Are Oritavancin and Dalbavancin More Cost Effective for Outpatient Parenteral Antimicrobial Therapy at a Veterans Affairs Medical Center?

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Are Oritavancin and Dalbavancin More Cost Effective for Outpatient Parenteral Antimicrobial Therapy at a Veterans Affairs Medical Center?

Oritavancin and dalbavancin are long acting lipoglycopeptides indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).1,2 Largely due to their long half-lives, prolonged tissue concentrations at sites of infection, tolerability, and minimal requirement for therapeutic drug monitoring, these agents are attractive options in outpatient settings.3,4 A 1- or 2-dose treatment of oritavancin and dalbavancin may be sufficient for conditions traditionally treated with outpatient parenteral antimicrobial therapy (OPAT) via peripherally inserted central catheter (PICC).

Limited research supports the use of dalbavancin and oritavancin for bone and joint infections, infective endocarditis, and bloodstream infections (BSIs). However, the US Food and Drug Administration has approved an indication for the treatment of ABSSSI.3-9 Dosing for these off-label indications varies but typically consists of an initial intravenous (IV) dose (1000 mg, 1200 mg, or 1500 mg), with a subsequent dose 1 to 2 weeks later or administered once weekly.6-10

Due in part to the recent availability of oritavancin and dalbavancin relative to the publication of practice guidelines, their appropriate place in therapy continues to evolve based on emerging literature.11,12 One potential barrier of use for these medications is their cost. Based on the number of doses administered, the 2022 estimated total acquisition cost of therapy for oritavancin and dalbavancin was $1014 to $4397 and $3046 to $7150, respectively (eAppendix). Despite the high acquisition costs, these agents do not require the placement of an indwelling central line, can be administered in outpatient settings, and require minimal therapeutic dose monitoring compared to vancomycin.13-15 This medication use evaluation (MUE) compared the total cost of treatment with oritavancin and dalbavancin vs therapies traditionally used for OPAT or prolonged IV inpatient therapy.

METHODS

This retrospective MUE was conducted at the Boise Veterans Affairs Medical Center (BVAMC), a level 2 facility with an extensive rural catchment area. BVAMC provides many OPAT services, including medications, supplies, and dressing changes after initial clinic or inpatient education. Contracted vendors may also assist with at-home nursing care using supplies provided by the BVAMC. Cases were identified using an internal database of OPAT patients and those who received oritavancin or dalbavancin between September 1, 2017, and November 1, 2022. Patients aged ≥ 18 years who received ≥ 1 dose of oritavancin or dalbavancin for ABSSSI, osteomyelitis/joint infections, endocarditis, and BSI were included. Comparator treatments consisting of ≥ 1 week of vancomycin or daptomycin for ABSSSI, osteomyelitis/joint infections, endocarditis, and BSI were identified through review of OPAT and Infectious Diseases service consults during the same timeframe. Patients were excluded if any antibiotic was prescribed by a non- VA clinician, if medications were not provided by OPAT, or if chart review did not identify an ABSSSI, osteomyelitis/ joint infection, or BSI diagnosis.

Electronic medical record review was conducted using a standardized data collection form (eAppendix). Data collected included demographics, infectious diagnosis, treatment administered, administration procedures and related visits and treatment locations, outcomes including clinical failure, adverse events (AEs), and hospital readmission.

Clinical failure was defined as readmission or death due to worsening infection or readmission secondary to a documented potential AE to the evaluated antibiotics within 90 days after initiation. Clinical failures excluded readmissions not associated with infection including comorbidities or elective procedures. AEs included new onset renal failure (serum creatinine ≥ 0.5 mg/dL), neutropenia (neutrophils ≤ 500), thrombocytopenia (platelets < 100,000), eosinophilia (> 15% eosinophils), or creatine phosphokinase > 10 times the upper limit of normal, and Clostridioides difficile (C. difficile) infection. Line complications included thrombophlebitis, local inflammation, or infection requiring line replacement (eAppendix).

A cost-minimization approach was used to assess the total cost of treatment.16 Patients who received oritavancin or dalbavancin were matched with patients that received vancomycin and daptomycin for the same indication and about 1 month of initiation through the randomization function in Microsoft Excel. This accounted for changes in personnel, nonformulary drug approvals, cost, and changes in practice during the pandemic. Costs were calculated using a decision tree as a base model (Figure 1). In this model, each treatment dyad was assessed for the presence or absence of clinical failure, adverse event (medication and line complications), and treatment setting endpoints. Cost estimates were tabulated for each patient that received treatment using published VA data, literature, pharmacoeconomist guidance, or best faith effort based on workflow. 17-20 All cost estimates were based on 2022 figures or adjusted for inflation if obtained prior to 2022. Secondary endpoints of this analysis included estimated total cost of medication acquisition, administration supplies, laboratory monitoring, and human resources for OPAT visits or receiving home-health services.

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This evaluation was classified by the BVAMC Medication Use Evaluation research determination subcommittee as a quality improvement project and was considered exempt from VA Human Subjects Research requirements based on the VA Policy Handbook guideline 1058.05.

RESULTS

The study identified 44 patients who received dalbavancin or oritavancin between September 1, 2017, and October 31, 2022. Thirty-nine patients were included in the analysis: 24 received oritavancin and 15 received dalbavancin and were matched by indication to 10 patients who received vancomycin and 8 patients who received daptomycin. Three patients could not be matched by indication of ABSSSI (Figure 2). Most patients were male, aged > 65 years, and were treated for osteomyelitis (Table 1). No patients were treated for infective endocarditis. A myriad of concomitant antibiotics were used to treat patients and culture results indicated that most infections treated with oritavancin and dalbavancin were polymicrobial.

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The mean total cost of therapy per patient receiving oritavancin, dalbavancin, vancomycin, and daptomycin was $35,630, $59,612, $73,333, and $73,708, respectively (Figure 3). When stratified by indication, 27 patients (69%) in the oritavancin/dalbavancin group were treated for osteomyelitis/ joint infections (16 oritavancin, 11 dalbavancin), 9 patients (23%) were treated for BSI (6 oritavancin, 3 dalbavancin), and 3 patients (8%) were treated for ABSSSI (2 oritavancin, 1 dalbavancin). The mean cost per patient for osteomyelitis/joint infections with oritavancin, dalbavancin, vancomycin, and daptomycin was $34,678, $54,224, $87,488, and $85,044, respectively. The mean cost per patient for BSI for oritavancin, dalbavancin, vancomycin, and daptomycin was $35,048, $75,349, $40,305, and $68,068, respectively. The mean cost per patient for ABSSSI for oritavancin and dalbavancin was $44,771 and $71,672.51.

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Estimated total drug cost represents the cost of drug acquisition, administration supplies, laboratory monitoring, and human resources for OPAT visits or receiving home health services. The mean cost per patient of drug-related therapy for oritavancin, dalbavancin, vancomycin, and daptomycin was $2203, $5924, $3637, and $7146, respectively (Table 2).

FDP04206236_T2

The mean cost per patient for osteomyelitis therapy for oritavancin, dalbavancin, vancomycin, and daptomycin was $2375, $6775, $4164, $8152, respectively. The mean cost of per patient for BSI treatment with oritavancin, dalbavancin, vancomycin, and daptomycin was $1737, $3475, $2409, and $1016, respectively. The mean cost per patient for oritavancin and dalbavancin for ABSSSI treatment, was $1553 and $3910, respectively.

Setting-related costs include expenses from inpatient admissions and postdischarge stays at community living centers (CLCs), skilled nursing facilities (SNFs), or rehabilitation facilities (RFs) for the duration of antimicrobial therapy. The mean setting-related therapy cost for osteomyelitis treatment with oritavancin, dalbavancin, vancomycin, and daptomycin was $27,852, $17,815, $83,324, and $72,856, respectively. The mean setting-related therapy cost per patient for BSI treatment with oritavancin, dalbavancin, vancomycin, and daptomycin was $33,310, $60,668, $37,734, and $67,074, respectively. The mean setting-related therapy cost per patient for ABSSSI treatment for oritavancin and dalbavancin was $43,218 and $67,762.00, respectively.

Six of 39 patients (15%) had clinical failure: 2 patients with oritavancin and 4 patients with dalbavancin. Four patients were readmitted for worsening infection and 2 for AEs. One patient (13%) in the daptomycin group had clinical failure due to readmission for worsening infection. There was no clinical failure with vancomycin. The costs associated with clinical failure per patient for oritavancin, dalbavancin, vancomycin, and daptomycin were $2925, $23,972, $0, and $3601, respectively (Table 3).

FDP04206236_T3

Thirty-eight patients (97%) who received oritavancin or dalbavancin had difficulty adhering to vancomycin or daptomycin OPAT. Oritavancin or dalbavancin was used in 10 patients (26%) who lacked support at home and 15 patients (38%) who had either a contraindication or previous failure with other antimicrobials, which were the most common explanations.

DISCUSSION

Long-acting lipoglycopeptides represent a potential alternative to home IV therapy that can avoid prolonged IV access with traditional OPAT. This offers significant advantages, allowing patients to be discharged from the hospital early, especially in rural areas with little OPAT infrastructure or those with logistic challenges. In this analysis, treatment with oritavancin for osteomyelitis, BSI, or ABSSSI, yielded an estimated cost savings of about $37,000 per patient, compared to treatment of matched indications with vancomycin and daptomycin. For every patient treated with dalbavancin for osteomyelitis, BSI, or ABSSSI, the cost savings was about $13,000 per patient, compared to treatment of matched indications for daptomycin and vancomycin. The estimated cost savings per patient for oritavancin was similar to previously published projections ($30,500 to $55,831).15

Cost savings were primarily driven by setting-related costs. The greatest contrast between the oritavancin and dalbavancin group compared to the vancomycin and daptomycin group was the length of stay in a postdischarge CLC, SNF, or RF setting. This analysis estimated that for every patient treated with oritavancin for osteomyelitis, the setting-related cost savings per patient was about $55,000 compared with vancomycin, and about $45,000 per patient compared with daptomycin. Furthermore, the estimated setting-related cost savings for osteomyelitis treatment with dalbavancin was about $65,000 compared with vancomycin and about $55,000 compared with daptomycin.

Clinical failure occurred with greater frequency in the oritavancin and dalbavancin groups (15%), compared with the vancomycin (0%) and daptomycin (13%) groups. Although the clinical failure rates in patients with osteomyelitis treated with oritavancin and dalbavancin compared with daptomycin were like those in previously published research (10%-30%), the rates of clinical failure for vancomycin in this analysis were lower than those in the oritavancin and dalbavancin group.8,21,22 The discrepancy in clinical failure rates between this analysis and previous research is likely due to selection bias. Based on the percentages of clinical failure found in the analysis, it is not surprising to note that the total clinical failure-related cost per patient was higher for oritavancin and dalbavancin compared to vancomycin, but similar between oritavancin and daptomycin.

This analysis also found that 15% of patients in the oritavancin and dalbavancin group experienced an AE compared to 10% of patients in the vancomycin group and none in the daptomycin group. In the oritavancin and dalbavancin group, the 2 most common AEs were infusion-related reactions and C. difficile colitis. Although infusion related reactions are easier to correspond to oritavancin and dalbavancin, it becomes difficult to definitively attribute the occurrence of C. difficile to these drugs as many patients were receiving concomitant antibiotics. Although not a primary or secondary objective, the rate of IV-line AEs were more prevalent in the vancomycin (10%), and daptomycin (13%) groups, compared to none in the oritavancin and dalbavancin group. This finding was expected; oritavancin and dalbavancin do not require a central IV line for administration.

Pharmacoeconomic literature continues to emerge with long-acting lipoglycopeptides. A 2024 Italian retrospective single-center analysis of 62 patients reported mean cost reductions > €3200 per patient (> $3400) given dalbavancin compared with the standard of care for ABSSSI or more deep-seeded infections such as osteomyelitis.23 A 2023 Spanish observational multicenter analysis of 124 patients with infective endocarditis demonstrated high efficacy, safety and cost-effectiveness with dalbavancin vs conventional treatments, with a mean savings of > €5548 per patient (> $6200).24 An analysis of the implementation of a dalbavancin order pathway for ABSSSI to avert inpatient admissions at 11 US emergency departments found a mean cost savings of $5133 per patient and $1211 per hospitalization day avoided, compared with inpatient usual care.25

Conversely, a multicenter, retrospective study of 209 patients in a community-based health care system failed to show a financial benefit for dalbavancin use when compared to standard of care for ABSSSI with higher readmission rates.26 Turco et al also reported increased cost results for 64 patients who received dalbavancin vs standard of care for ABSSSI.27 These discordant findings in ABSSSI studies may be impacted by the authors' patient selection choices and cost assumptions, especially with significantly cheaper oral alternatives. More data are needed to best identify the optimal therapeutic use for the long-acting lipoglycopeptides.

Limitations

The most significant limitation in this analysis was selection bias: 38 of 39 patients (97%) who received dalbavancin or oritavancin had a documented reason that described why OPAT therapy with traditional medications would not be optimal, including logistics, AEs, or clinical failures. Most patients treated with vancomycin and daptomycin were admitted into a SNF, RF, or CLC for the remainder of their treatment, allowing for closer monitoring and care compared to patients treated with oritavancin and dalbavancin, but at a greater cost. For patients sent to a community based SNF or RF, laboratory data were not available unless internally drawn or documented in the electronic medical record.

Additionally, not all cost data were available from VA sources; some were applied from literature, pharmacoeconomist, or best faith effort based on workflow. The cost data from third party contractors providing OPAT services to some BVAMC patients during the time frame of this analysis were not available. Due to its small sample size, outliers had the potential to affect averages reported and accuracy of the cost analysis. Emerging evidence suggests that daptomycin doses higher than the manufacturer-recommended regimen may be required for select indications, a factor that could affect cost, AEs, and efficacy outcomes.28 The acquisition cost of oritavancin and dalbavancin may vary by institution (ie, VA contract prices vs non- VA contract prices) and change over time. A current assessment of cost is needed to best visualize institutional benefit.

Finally, while the patient demographic of this MUE was highly representative of the demographic treated at the BVAMC (males aged >65 years), it may not be applicable to external patient populations. This analysis evaluated off-label indications for these medications. Consequently, this analysis would likely not be applicable to non-VA institution, as third-party payers (eg, insurance) are unlikely to cover medications for off-label indications.

CONCLUSIONS

This study found cost savings associated with the use of oritavancin and dalbavancin compared with vancomycin and daptomycin, particularly for the treatment of osteomyelitis. As safety and efficacy data continues to emerge, the use of long-acting lipoglycopeptides appears to be an increasingly attractive alternative option compared to traditional outpatient antimicrobial therapy, depending on the structure of the program. Larger, multicenter cost-effectiveness studies are needed to further establish the impact of these novel agents.

References
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  2. Orbactiv. Package insert. Melinta Therapeutics; 2022.
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  4. Simonetti O, Rizzetto G, Molinelli E, Cirioni O, Offidani A. Review: a safety profile of dalbavancin for on- and offlabel utilization. Ther Clin Risk Manag. 2021;17:223-232. doi:10.2147/TCRM.S271445
  5. Bloem A, Bax HI, Yusuf E, Verkaik NJ. New-generation antibiotics for treatment of gram-positive infections: a review with focus on endocarditis and osteomyelitis. J Clin Med. 2021;10(8):1743. doi:10.3390/jcm10081743
  6. Thomas G, Henao-Martínez AF, Franco-Paredes C, Chastain DB. Treatment of osteoarticular, cardiovascular, intravascular-catheter-related and other complicated infections with dalbavancin and oritavancin: a systematic review. Int J Antimicrob Agents. 2020;56(3):106069. doi:10.1016/j.ijantimicag.2020.106069
  7. Rappo U, Puttagunta S, Shevchenko V, et al. Dalbavancin for the treatment of osteomyelitis in adult patients: a randomized clinical trial of efficacy and safety. Open Forum Infect Dis. 2018;6(1):ofy331. doi:10.1093/ofid/ofy331
  8. Cain AR, Bremmer DN, Carr DR, et al. Effectiveness of dalbavancin compared with standard of care for the treatment of osteomyelitis: a real-world analysis. Open Forum Infect Dis. 2021;9(2):ofab589. doi:10.1093/ofid/ofab589
  9. Van Hise NW, Chundi V, Didwania V, et al. Treatment of acute osteomyelitis with once-weekly oritavancin: a two-year, multicenter, retrospective study. Drugs Real World Outcomes. 2020;7(Suppl 1):41-45. doi:10.1007/s40801-020-00195-7
  10. Cooper MM, Preslaski CR, Shihadeh KC, Hawkins KL, Jenkins TC. Multiple-dose dalbavancin regimens as the predominant treatment of deep-seated or endovascular infections: a scoping review. Open Forum Infect Dis. 2021;8(11):ofab486. doi:10.1093/ofid/ofab486
  11. Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis in adults: diagnosis, antimicrobial therapy, and management of complications: a scientific statement for healthcare professionals from the American Heart Association. Circulation. 2015;132(15):1435-1486. doi:10.1161/CIR.0000000000000296
  12. Berbari EF, Kanj SS, Kowalski TJ, et al. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015;61(6):e26-46. doi:10.1093/cid/civ482
  13. Arrieta-Loitegui M, Caro-Teller JM, Ortiz-Pérez S, López- Medrano F, San Juan-Garrido R, Ferrari-Piquero JM. Effectiveness, safety, and cost analysis of dalbavancin in clinical practice. Eur J Hosp Pharm. 2022;29(1):55-58. doi:10.1136/ejhpharm-2020-002315
  14. Pascale R, Maccaro A, Mikus E, et al. A retrospective multicentre study on dalbavancin effectiveness and cost-evaluation in sternotomic wound infection treatment: DALBA SWIT study. J Glob Antimicrob Resist. 2022;30:390-394. doi:10.1016/j.jgar.2022.07.018
  15. Antosz K, Al-Hasan MN, Lu ZK, et at. Clinical utility and cost effectiveness of long-acting lipoglycopeptides used in deep seated infections among patients with social and economic barriers to care. Pharmacy (Basel). 2021;10(1):1. doi:10.3390/pharmacy10010001
  16. Roberts MS. Economic aspects of evaluation. In: Friedman CP, Wyatt JC, eds. Evaluation Methods in Biomedical Informatics. 2nd ed. Springer; 2006:301-337.
  17. US Department of Veterans Affairs. HERC inpatient average cost data. Updated May 1, 2025. Accessed May 9, 2025. https://www.herc.research.va.gov/include/page.asp?id=inpatient
  18. US Department of Veterans Affairs. HERC Outpatient average cost dataset. Updated May 1, 2025. Accessed May 9, 2025. https://www.herc.research.va.gov/include/page.asp?id=outpatient
  19. Ektare V, Khachatryan A, Xue M, Dunne M, Johnson K, Stephens J. Assessing the economic value of avoiding hospital admissions by shifting the management of gram + acute bacterial skin and skin-structure infections to an outpatient care setting. J Med Econ. 2015;18(12):1092-1101. doi:10.3111/13696998.2015.1078339
  20. Ruh CA, Parameswaran GI, Wojciechowski AL, Mergenhagen KA. Outcomes and pharmacoeconomic analysis of a home intravenous antibiotic infusion program in veterans. Clin Ther. 2015;37(11):2527-2535. doi:10.1016/j.clinthera.2015.09.009
  21. Nakrani M, Yu D, Skikka M, et al. Comparison of vancomycin and daptomycin complications and interventions in outpatient parenteral antimicrobial therapy. Open Forum Infect Dis. 2020;7(Suppl 1):S361-S362. doi:10.1093/ofid/ofaa439.791
  22. Scoble PJ, Reilly J, Tilloston GS. Real-world use of oritavancin for the treatment of osteomyelitis. Drugs Real World Outcomes. 2020;7(Suppl 1):46-54. doi:10.1007/s40801-020-00194-8
  23. Segala D, Barbieri M, Di Nuzzo M, et al. Clinical, organizational, and pharmacoeconomic perspectives of dalbavancin vs standard of care in the infectious disease network. Glob Reg Health Technol Assess. 2024;11(Suppl 2):5-12. doi:10.33393/grhta.2024.3094
  24. Gómez A, et al. EN-DALBACEN 2.0 Cohort: real-life study of dalbavancin as sequential/consolidation therapy in patients with infective endocarditis due to Gram-positive cocci. Int J Antimicrob Agents. 2023;62(3):106918. doi:10.1016/j.ijantimicag.2023.106918
  25. LoVecchio F, McCarthy MW, Ye X, et al. Single intravenous dose dalbavancin pathway for the treatment of acute bacterial skin and skin structure infections: considerations for emergency department implementation and cost savings. J Emerg Med. 2024;67(2):e217-e229. doi:10.1016/j.jemermed.2024.03.003
  26. Gonzalez J, Andrade DC, Niu J. Cost-consequence analysis of single-dose dalbavancin versus standard of care for the treatment of acute bacterial skin and skin structure infections in a multisite healthcare system. Clin Infect Dis. 2021;73(7):e1436-e1442. doi:10.1093/cid/ciaa1732
  27. Turco NJ, Kane-Gill SL, Hernandez I, Oleksiuk LM, D’Amico F, Pickering AJ. A cost-minimization analysis of dalbavancin compared to conventional therapy for the outpatient treatment of acute bacterial skin and skin-structure infections. Expert Opin Pharmacother. 2018;19(4):319-325. doi:10.1080/14656566.2018.1442439
  28. Jones TW, Jun AH, Michal JL, Olney WJ. High-dose daptomycin and clinical applications. Ann Pharmacother. 2021;55(11):1363-1378. doi:10.1177/1060028021991943
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Correspondence: Tomasz Jodlowski (tomasz.jodlowski@va.gov)

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Fed Pract. 2025;42(6). Published online June 17. doi:10.12788/fp.0571

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Fed Pract. 2025;42(6). Published online June 17. doi:10.12788/fp.0571

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Oritavancin and dalbavancin are long acting lipoglycopeptides indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).1,2 Largely due to their long half-lives, prolonged tissue concentrations at sites of infection, tolerability, and minimal requirement for therapeutic drug monitoring, these agents are attractive options in outpatient settings.3,4 A 1- or 2-dose treatment of oritavancin and dalbavancin may be sufficient for conditions traditionally treated with outpatient parenteral antimicrobial therapy (OPAT) via peripherally inserted central catheter (PICC).

Limited research supports the use of dalbavancin and oritavancin for bone and joint infections, infective endocarditis, and bloodstream infections (BSIs). However, the US Food and Drug Administration has approved an indication for the treatment of ABSSSI.3-9 Dosing for these off-label indications varies but typically consists of an initial intravenous (IV) dose (1000 mg, 1200 mg, or 1500 mg), with a subsequent dose 1 to 2 weeks later or administered once weekly.6-10

Due in part to the recent availability of oritavancin and dalbavancin relative to the publication of practice guidelines, their appropriate place in therapy continues to evolve based on emerging literature.11,12 One potential barrier of use for these medications is their cost. Based on the number of doses administered, the 2022 estimated total acquisition cost of therapy for oritavancin and dalbavancin was $1014 to $4397 and $3046 to $7150, respectively (eAppendix). Despite the high acquisition costs, these agents do not require the placement of an indwelling central line, can be administered in outpatient settings, and require minimal therapeutic dose monitoring compared to vancomycin.13-15 This medication use evaluation (MUE) compared the total cost of treatment with oritavancin and dalbavancin vs therapies traditionally used for OPAT or prolonged IV inpatient therapy.

METHODS

This retrospective MUE was conducted at the Boise Veterans Affairs Medical Center (BVAMC), a level 2 facility with an extensive rural catchment area. BVAMC provides many OPAT services, including medications, supplies, and dressing changes after initial clinic or inpatient education. Contracted vendors may also assist with at-home nursing care using supplies provided by the BVAMC. Cases were identified using an internal database of OPAT patients and those who received oritavancin or dalbavancin between September 1, 2017, and November 1, 2022. Patients aged ≥ 18 years who received ≥ 1 dose of oritavancin or dalbavancin for ABSSSI, osteomyelitis/joint infections, endocarditis, and BSI were included. Comparator treatments consisting of ≥ 1 week of vancomycin or daptomycin for ABSSSI, osteomyelitis/joint infections, endocarditis, and BSI were identified through review of OPAT and Infectious Diseases service consults during the same timeframe. Patients were excluded if any antibiotic was prescribed by a non- VA clinician, if medications were not provided by OPAT, or if chart review did not identify an ABSSSI, osteomyelitis/ joint infection, or BSI diagnosis.

Electronic medical record review was conducted using a standardized data collection form (eAppendix). Data collected included demographics, infectious diagnosis, treatment administered, administration procedures and related visits and treatment locations, outcomes including clinical failure, adverse events (AEs), and hospital readmission.

Clinical failure was defined as readmission or death due to worsening infection or readmission secondary to a documented potential AE to the evaluated antibiotics within 90 days after initiation. Clinical failures excluded readmissions not associated with infection including comorbidities or elective procedures. AEs included new onset renal failure (serum creatinine ≥ 0.5 mg/dL), neutropenia (neutrophils ≤ 500), thrombocytopenia (platelets < 100,000), eosinophilia (> 15% eosinophils), or creatine phosphokinase > 10 times the upper limit of normal, and Clostridioides difficile (C. difficile) infection. Line complications included thrombophlebitis, local inflammation, or infection requiring line replacement (eAppendix).

A cost-minimization approach was used to assess the total cost of treatment.16 Patients who received oritavancin or dalbavancin were matched with patients that received vancomycin and daptomycin for the same indication and about 1 month of initiation through the randomization function in Microsoft Excel. This accounted for changes in personnel, nonformulary drug approvals, cost, and changes in practice during the pandemic. Costs were calculated using a decision tree as a base model (Figure 1). In this model, each treatment dyad was assessed for the presence or absence of clinical failure, adverse event (medication and line complications), and treatment setting endpoints. Cost estimates were tabulated for each patient that received treatment using published VA data, literature, pharmacoeconomist guidance, or best faith effort based on workflow. 17-20 All cost estimates were based on 2022 figures or adjusted for inflation if obtained prior to 2022. Secondary endpoints of this analysis included estimated total cost of medication acquisition, administration supplies, laboratory monitoring, and human resources for OPAT visits or receiving home-health services.

FDP04206236_F1

This evaluation was classified by the BVAMC Medication Use Evaluation research determination subcommittee as a quality improvement project and was considered exempt from VA Human Subjects Research requirements based on the VA Policy Handbook guideline 1058.05.

RESULTS

The study identified 44 patients who received dalbavancin or oritavancin between September 1, 2017, and October 31, 2022. Thirty-nine patients were included in the analysis: 24 received oritavancin and 15 received dalbavancin and were matched by indication to 10 patients who received vancomycin and 8 patients who received daptomycin. Three patients could not be matched by indication of ABSSSI (Figure 2). Most patients were male, aged > 65 years, and were treated for osteomyelitis (Table 1). No patients were treated for infective endocarditis. A myriad of concomitant antibiotics were used to treat patients and culture results indicated that most infections treated with oritavancin and dalbavancin were polymicrobial.

FDP04206236_F2FDP04206236_T1

The mean total cost of therapy per patient receiving oritavancin, dalbavancin, vancomycin, and daptomycin was $35,630, $59,612, $73,333, and $73,708, respectively (Figure 3). When stratified by indication, 27 patients (69%) in the oritavancin/dalbavancin group were treated for osteomyelitis/ joint infections (16 oritavancin, 11 dalbavancin), 9 patients (23%) were treated for BSI (6 oritavancin, 3 dalbavancin), and 3 patients (8%) were treated for ABSSSI (2 oritavancin, 1 dalbavancin). The mean cost per patient for osteomyelitis/joint infections with oritavancin, dalbavancin, vancomycin, and daptomycin was $34,678, $54,224, $87,488, and $85,044, respectively. The mean cost per patient for BSI for oritavancin, dalbavancin, vancomycin, and daptomycin was $35,048, $75,349, $40,305, and $68,068, respectively. The mean cost per patient for ABSSSI for oritavancin and dalbavancin was $44,771 and $71,672.51.

FDP04206236_F3

Estimated total drug cost represents the cost of drug acquisition, administration supplies, laboratory monitoring, and human resources for OPAT visits or receiving home health services. The mean cost per patient of drug-related therapy for oritavancin, dalbavancin, vancomycin, and daptomycin was $2203, $5924, $3637, and $7146, respectively (Table 2).

FDP04206236_T2

The mean cost per patient for osteomyelitis therapy for oritavancin, dalbavancin, vancomycin, and daptomycin was $2375, $6775, $4164, $8152, respectively. The mean cost of per patient for BSI treatment with oritavancin, dalbavancin, vancomycin, and daptomycin was $1737, $3475, $2409, and $1016, respectively. The mean cost per patient for oritavancin and dalbavancin for ABSSSI treatment, was $1553 and $3910, respectively.

Setting-related costs include expenses from inpatient admissions and postdischarge stays at community living centers (CLCs), skilled nursing facilities (SNFs), or rehabilitation facilities (RFs) for the duration of antimicrobial therapy. The mean setting-related therapy cost for osteomyelitis treatment with oritavancin, dalbavancin, vancomycin, and daptomycin was $27,852, $17,815, $83,324, and $72,856, respectively. The mean setting-related therapy cost per patient for BSI treatment with oritavancin, dalbavancin, vancomycin, and daptomycin was $33,310, $60,668, $37,734, and $67,074, respectively. The mean setting-related therapy cost per patient for ABSSSI treatment for oritavancin and dalbavancin was $43,218 and $67,762.00, respectively.

Six of 39 patients (15%) had clinical failure: 2 patients with oritavancin and 4 patients with dalbavancin. Four patients were readmitted for worsening infection and 2 for AEs. One patient (13%) in the daptomycin group had clinical failure due to readmission for worsening infection. There was no clinical failure with vancomycin. The costs associated with clinical failure per patient for oritavancin, dalbavancin, vancomycin, and daptomycin were $2925, $23,972, $0, and $3601, respectively (Table 3).

FDP04206236_T3

Thirty-eight patients (97%) who received oritavancin or dalbavancin had difficulty adhering to vancomycin or daptomycin OPAT. Oritavancin or dalbavancin was used in 10 patients (26%) who lacked support at home and 15 patients (38%) who had either a contraindication or previous failure with other antimicrobials, which were the most common explanations.

DISCUSSION

Long-acting lipoglycopeptides represent a potential alternative to home IV therapy that can avoid prolonged IV access with traditional OPAT. This offers significant advantages, allowing patients to be discharged from the hospital early, especially in rural areas with little OPAT infrastructure or those with logistic challenges. In this analysis, treatment with oritavancin for osteomyelitis, BSI, or ABSSSI, yielded an estimated cost savings of about $37,000 per patient, compared to treatment of matched indications with vancomycin and daptomycin. For every patient treated with dalbavancin for osteomyelitis, BSI, or ABSSSI, the cost savings was about $13,000 per patient, compared to treatment of matched indications for daptomycin and vancomycin. The estimated cost savings per patient for oritavancin was similar to previously published projections ($30,500 to $55,831).15

Cost savings were primarily driven by setting-related costs. The greatest contrast between the oritavancin and dalbavancin group compared to the vancomycin and daptomycin group was the length of stay in a postdischarge CLC, SNF, or RF setting. This analysis estimated that for every patient treated with oritavancin for osteomyelitis, the setting-related cost savings per patient was about $55,000 compared with vancomycin, and about $45,000 per patient compared with daptomycin. Furthermore, the estimated setting-related cost savings for osteomyelitis treatment with dalbavancin was about $65,000 compared with vancomycin and about $55,000 compared with daptomycin.

Clinical failure occurred with greater frequency in the oritavancin and dalbavancin groups (15%), compared with the vancomycin (0%) and daptomycin (13%) groups. Although the clinical failure rates in patients with osteomyelitis treated with oritavancin and dalbavancin compared with daptomycin were like those in previously published research (10%-30%), the rates of clinical failure for vancomycin in this analysis were lower than those in the oritavancin and dalbavancin group.8,21,22 The discrepancy in clinical failure rates between this analysis and previous research is likely due to selection bias. Based on the percentages of clinical failure found in the analysis, it is not surprising to note that the total clinical failure-related cost per patient was higher for oritavancin and dalbavancin compared to vancomycin, but similar between oritavancin and daptomycin.

This analysis also found that 15% of patients in the oritavancin and dalbavancin group experienced an AE compared to 10% of patients in the vancomycin group and none in the daptomycin group. In the oritavancin and dalbavancin group, the 2 most common AEs were infusion-related reactions and C. difficile colitis. Although infusion related reactions are easier to correspond to oritavancin and dalbavancin, it becomes difficult to definitively attribute the occurrence of C. difficile to these drugs as many patients were receiving concomitant antibiotics. Although not a primary or secondary objective, the rate of IV-line AEs were more prevalent in the vancomycin (10%), and daptomycin (13%) groups, compared to none in the oritavancin and dalbavancin group. This finding was expected; oritavancin and dalbavancin do not require a central IV line for administration.

Pharmacoeconomic literature continues to emerge with long-acting lipoglycopeptides. A 2024 Italian retrospective single-center analysis of 62 patients reported mean cost reductions > €3200 per patient (> $3400) given dalbavancin compared with the standard of care for ABSSSI or more deep-seeded infections such as osteomyelitis.23 A 2023 Spanish observational multicenter analysis of 124 patients with infective endocarditis demonstrated high efficacy, safety and cost-effectiveness with dalbavancin vs conventional treatments, with a mean savings of > €5548 per patient (> $6200).24 An analysis of the implementation of a dalbavancin order pathway for ABSSSI to avert inpatient admissions at 11 US emergency departments found a mean cost savings of $5133 per patient and $1211 per hospitalization day avoided, compared with inpatient usual care.25

Conversely, a multicenter, retrospective study of 209 patients in a community-based health care system failed to show a financial benefit for dalbavancin use when compared to standard of care for ABSSSI with higher readmission rates.26 Turco et al also reported increased cost results for 64 patients who received dalbavancin vs standard of care for ABSSSI.27 These discordant findings in ABSSSI studies may be impacted by the authors' patient selection choices and cost assumptions, especially with significantly cheaper oral alternatives. More data are needed to best identify the optimal therapeutic use for the long-acting lipoglycopeptides.

Limitations

The most significant limitation in this analysis was selection bias: 38 of 39 patients (97%) who received dalbavancin or oritavancin had a documented reason that described why OPAT therapy with traditional medications would not be optimal, including logistics, AEs, or clinical failures. Most patients treated with vancomycin and daptomycin were admitted into a SNF, RF, or CLC for the remainder of their treatment, allowing for closer monitoring and care compared to patients treated with oritavancin and dalbavancin, but at a greater cost. For patients sent to a community based SNF or RF, laboratory data were not available unless internally drawn or documented in the electronic medical record.

Additionally, not all cost data were available from VA sources; some were applied from literature, pharmacoeconomist, or best faith effort based on workflow. The cost data from third party contractors providing OPAT services to some BVAMC patients during the time frame of this analysis were not available. Due to its small sample size, outliers had the potential to affect averages reported and accuracy of the cost analysis. Emerging evidence suggests that daptomycin doses higher than the manufacturer-recommended regimen may be required for select indications, a factor that could affect cost, AEs, and efficacy outcomes.28 The acquisition cost of oritavancin and dalbavancin may vary by institution (ie, VA contract prices vs non- VA contract prices) and change over time. A current assessment of cost is needed to best visualize institutional benefit.

Finally, while the patient demographic of this MUE was highly representative of the demographic treated at the BVAMC (males aged >65 years), it may not be applicable to external patient populations. This analysis evaluated off-label indications for these medications. Consequently, this analysis would likely not be applicable to non-VA institution, as third-party payers (eg, insurance) are unlikely to cover medications for off-label indications.

CONCLUSIONS

This study found cost savings associated with the use of oritavancin and dalbavancin compared with vancomycin and daptomycin, particularly for the treatment of osteomyelitis. As safety and efficacy data continues to emerge, the use of long-acting lipoglycopeptides appears to be an increasingly attractive alternative option compared to traditional outpatient antimicrobial therapy, depending on the structure of the program. Larger, multicenter cost-effectiveness studies are needed to further establish the impact of these novel agents.

Oritavancin and dalbavancin are long acting lipoglycopeptides indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).1,2 Largely due to their long half-lives, prolonged tissue concentrations at sites of infection, tolerability, and minimal requirement for therapeutic drug monitoring, these agents are attractive options in outpatient settings.3,4 A 1- or 2-dose treatment of oritavancin and dalbavancin may be sufficient for conditions traditionally treated with outpatient parenteral antimicrobial therapy (OPAT) via peripherally inserted central catheter (PICC).

Limited research supports the use of dalbavancin and oritavancin for bone and joint infections, infective endocarditis, and bloodstream infections (BSIs). However, the US Food and Drug Administration has approved an indication for the treatment of ABSSSI.3-9 Dosing for these off-label indications varies but typically consists of an initial intravenous (IV) dose (1000 mg, 1200 mg, or 1500 mg), with a subsequent dose 1 to 2 weeks later or administered once weekly.6-10

Due in part to the recent availability of oritavancin and dalbavancin relative to the publication of practice guidelines, their appropriate place in therapy continues to evolve based on emerging literature.11,12 One potential barrier of use for these medications is their cost. Based on the number of doses administered, the 2022 estimated total acquisition cost of therapy for oritavancin and dalbavancin was $1014 to $4397 and $3046 to $7150, respectively (eAppendix). Despite the high acquisition costs, these agents do not require the placement of an indwelling central line, can be administered in outpatient settings, and require minimal therapeutic dose monitoring compared to vancomycin.13-15 This medication use evaluation (MUE) compared the total cost of treatment with oritavancin and dalbavancin vs therapies traditionally used for OPAT or prolonged IV inpatient therapy.

METHODS

This retrospective MUE was conducted at the Boise Veterans Affairs Medical Center (BVAMC), a level 2 facility with an extensive rural catchment area. BVAMC provides many OPAT services, including medications, supplies, and dressing changes after initial clinic or inpatient education. Contracted vendors may also assist with at-home nursing care using supplies provided by the BVAMC. Cases were identified using an internal database of OPAT patients and those who received oritavancin or dalbavancin between September 1, 2017, and November 1, 2022. Patients aged ≥ 18 years who received ≥ 1 dose of oritavancin or dalbavancin for ABSSSI, osteomyelitis/joint infections, endocarditis, and BSI were included. Comparator treatments consisting of ≥ 1 week of vancomycin or daptomycin for ABSSSI, osteomyelitis/joint infections, endocarditis, and BSI were identified through review of OPAT and Infectious Diseases service consults during the same timeframe. Patients were excluded if any antibiotic was prescribed by a non- VA clinician, if medications were not provided by OPAT, or if chart review did not identify an ABSSSI, osteomyelitis/ joint infection, or BSI diagnosis.

Electronic medical record review was conducted using a standardized data collection form (eAppendix). Data collected included demographics, infectious diagnosis, treatment administered, administration procedures and related visits and treatment locations, outcomes including clinical failure, adverse events (AEs), and hospital readmission.

Clinical failure was defined as readmission or death due to worsening infection or readmission secondary to a documented potential AE to the evaluated antibiotics within 90 days after initiation. Clinical failures excluded readmissions not associated with infection including comorbidities or elective procedures. AEs included new onset renal failure (serum creatinine ≥ 0.5 mg/dL), neutropenia (neutrophils ≤ 500), thrombocytopenia (platelets < 100,000), eosinophilia (> 15% eosinophils), or creatine phosphokinase > 10 times the upper limit of normal, and Clostridioides difficile (C. difficile) infection. Line complications included thrombophlebitis, local inflammation, or infection requiring line replacement (eAppendix).

A cost-minimization approach was used to assess the total cost of treatment.16 Patients who received oritavancin or dalbavancin were matched with patients that received vancomycin and daptomycin for the same indication and about 1 month of initiation through the randomization function in Microsoft Excel. This accounted for changes in personnel, nonformulary drug approvals, cost, and changes in practice during the pandemic. Costs were calculated using a decision tree as a base model (Figure 1). In this model, each treatment dyad was assessed for the presence or absence of clinical failure, adverse event (medication and line complications), and treatment setting endpoints. Cost estimates were tabulated for each patient that received treatment using published VA data, literature, pharmacoeconomist guidance, or best faith effort based on workflow. 17-20 All cost estimates were based on 2022 figures or adjusted for inflation if obtained prior to 2022. Secondary endpoints of this analysis included estimated total cost of medication acquisition, administration supplies, laboratory monitoring, and human resources for OPAT visits or receiving home-health services.

FDP04206236_F1

This evaluation was classified by the BVAMC Medication Use Evaluation research determination subcommittee as a quality improvement project and was considered exempt from VA Human Subjects Research requirements based on the VA Policy Handbook guideline 1058.05.

RESULTS

The study identified 44 patients who received dalbavancin or oritavancin between September 1, 2017, and October 31, 2022. Thirty-nine patients were included in the analysis: 24 received oritavancin and 15 received dalbavancin and were matched by indication to 10 patients who received vancomycin and 8 patients who received daptomycin. Three patients could not be matched by indication of ABSSSI (Figure 2). Most patients were male, aged > 65 years, and were treated for osteomyelitis (Table 1). No patients were treated for infective endocarditis. A myriad of concomitant antibiotics were used to treat patients and culture results indicated that most infections treated with oritavancin and dalbavancin were polymicrobial.

FDP04206236_F2FDP04206236_T1

The mean total cost of therapy per patient receiving oritavancin, dalbavancin, vancomycin, and daptomycin was $35,630, $59,612, $73,333, and $73,708, respectively (Figure 3). When stratified by indication, 27 patients (69%) in the oritavancin/dalbavancin group were treated for osteomyelitis/ joint infections (16 oritavancin, 11 dalbavancin), 9 patients (23%) were treated for BSI (6 oritavancin, 3 dalbavancin), and 3 patients (8%) were treated for ABSSSI (2 oritavancin, 1 dalbavancin). The mean cost per patient for osteomyelitis/joint infections with oritavancin, dalbavancin, vancomycin, and daptomycin was $34,678, $54,224, $87,488, and $85,044, respectively. The mean cost per patient for BSI for oritavancin, dalbavancin, vancomycin, and daptomycin was $35,048, $75,349, $40,305, and $68,068, respectively. The mean cost per patient for ABSSSI for oritavancin and dalbavancin was $44,771 and $71,672.51.

FDP04206236_F3

Estimated total drug cost represents the cost of drug acquisition, administration supplies, laboratory monitoring, and human resources for OPAT visits or receiving home health services. The mean cost per patient of drug-related therapy for oritavancin, dalbavancin, vancomycin, and daptomycin was $2203, $5924, $3637, and $7146, respectively (Table 2).

FDP04206236_T2

The mean cost per patient for osteomyelitis therapy for oritavancin, dalbavancin, vancomycin, and daptomycin was $2375, $6775, $4164, $8152, respectively. The mean cost of per patient for BSI treatment with oritavancin, dalbavancin, vancomycin, and daptomycin was $1737, $3475, $2409, and $1016, respectively. The mean cost per patient for oritavancin and dalbavancin for ABSSSI treatment, was $1553 and $3910, respectively.

Setting-related costs include expenses from inpatient admissions and postdischarge stays at community living centers (CLCs), skilled nursing facilities (SNFs), or rehabilitation facilities (RFs) for the duration of antimicrobial therapy. The mean setting-related therapy cost for osteomyelitis treatment with oritavancin, dalbavancin, vancomycin, and daptomycin was $27,852, $17,815, $83,324, and $72,856, respectively. The mean setting-related therapy cost per patient for BSI treatment with oritavancin, dalbavancin, vancomycin, and daptomycin was $33,310, $60,668, $37,734, and $67,074, respectively. The mean setting-related therapy cost per patient for ABSSSI treatment for oritavancin and dalbavancin was $43,218 and $67,762.00, respectively.

Six of 39 patients (15%) had clinical failure: 2 patients with oritavancin and 4 patients with dalbavancin. Four patients were readmitted for worsening infection and 2 for AEs. One patient (13%) in the daptomycin group had clinical failure due to readmission for worsening infection. There was no clinical failure with vancomycin. The costs associated with clinical failure per patient for oritavancin, dalbavancin, vancomycin, and daptomycin were $2925, $23,972, $0, and $3601, respectively (Table 3).

FDP04206236_T3

Thirty-eight patients (97%) who received oritavancin or dalbavancin had difficulty adhering to vancomycin or daptomycin OPAT. Oritavancin or dalbavancin was used in 10 patients (26%) who lacked support at home and 15 patients (38%) who had either a contraindication or previous failure with other antimicrobials, which were the most common explanations.

DISCUSSION

Long-acting lipoglycopeptides represent a potential alternative to home IV therapy that can avoid prolonged IV access with traditional OPAT. This offers significant advantages, allowing patients to be discharged from the hospital early, especially in rural areas with little OPAT infrastructure or those with logistic challenges. In this analysis, treatment with oritavancin for osteomyelitis, BSI, or ABSSSI, yielded an estimated cost savings of about $37,000 per patient, compared to treatment of matched indications with vancomycin and daptomycin. For every patient treated with dalbavancin for osteomyelitis, BSI, or ABSSSI, the cost savings was about $13,000 per patient, compared to treatment of matched indications for daptomycin and vancomycin. The estimated cost savings per patient for oritavancin was similar to previously published projections ($30,500 to $55,831).15

Cost savings were primarily driven by setting-related costs. The greatest contrast between the oritavancin and dalbavancin group compared to the vancomycin and daptomycin group was the length of stay in a postdischarge CLC, SNF, or RF setting. This analysis estimated that for every patient treated with oritavancin for osteomyelitis, the setting-related cost savings per patient was about $55,000 compared with vancomycin, and about $45,000 per patient compared with daptomycin. Furthermore, the estimated setting-related cost savings for osteomyelitis treatment with dalbavancin was about $65,000 compared with vancomycin and about $55,000 compared with daptomycin.

Clinical failure occurred with greater frequency in the oritavancin and dalbavancin groups (15%), compared with the vancomycin (0%) and daptomycin (13%) groups. Although the clinical failure rates in patients with osteomyelitis treated with oritavancin and dalbavancin compared with daptomycin were like those in previously published research (10%-30%), the rates of clinical failure for vancomycin in this analysis were lower than those in the oritavancin and dalbavancin group.8,21,22 The discrepancy in clinical failure rates between this analysis and previous research is likely due to selection bias. Based on the percentages of clinical failure found in the analysis, it is not surprising to note that the total clinical failure-related cost per patient was higher for oritavancin and dalbavancin compared to vancomycin, but similar between oritavancin and daptomycin.

This analysis also found that 15% of patients in the oritavancin and dalbavancin group experienced an AE compared to 10% of patients in the vancomycin group and none in the daptomycin group. In the oritavancin and dalbavancin group, the 2 most common AEs were infusion-related reactions and C. difficile colitis. Although infusion related reactions are easier to correspond to oritavancin and dalbavancin, it becomes difficult to definitively attribute the occurrence of C. difficile to these drugs as many patients were receiving concomitant antibiotics. Although not a primary or secondary objective, the rate of IV-line AEs were more prevalent in the vancomycin (10%), and daptomycin (13%) groups, compared to none in the oritavancin and dalbavancin group. This finding was expected; oritavancin and dalbavancin do not require a central IV line for administration.

Pharmacoeconomic literature continues to emerge with long-acting lipoglycopeptides. A 2024 Italian retrospective single-center analysis of 62 patients reported mean cost reductions > €3200 per patient (> $3400) given dalbavancin compared with the standard of care for ABSSSI or more deep-seeded infections such as osteomyelitis.23 A 2023 Spanish observational multicenter analysis of 124 patients with infective endocarditis demonstrated high efficacy, safety and cost-effectiveness with dalbavancin vs conventional treatments, with a mean savings of > €5548 per patient (> $6200).24 An analysis of the implementation of a dalbavancin order pathway for ABSSSI to avert inpatient admissions at 11 US emergency departments found a mean cost savings of $5133 per patient and $1211 per hospitalization day avoided, compared with inpatient usual care.25

Conversely, a multicenter, retrospective study of 209 patients in a community-based health care system failed to show a financial benefit for dalbavancin use when compared to standard of care for ABSSSI with higher readmission rates.26 Turco et al also reported increased cost results for 64 patients who received dalbavancin vs standard of care for ABSSSI.27 These discordant findings in ABSSSI studies may be impacted by the authors' patient selection choices and cost assumptions, especially with significantly cheaper oral alternatives. More data are needed to best identify the optimal therapeutic use for the long-acting lipoglycopeptides.

Limitations

The most significant limitation in this analysis was selection bias: 38 of 39 patients (97%) who received dalbavancin or oritavancin had a documented reason that described why OPAT therapy with traditional medications would not be optimal, including logistics, AEs, or clinical failures. Most patients treated with vancomycin and daptomycin were admitted into a SNF, RF, or CLC for the remainder of their treatment, allowing for closer monitoring and care compared to patients treated with oritavancin and dalbavancin, but at a greater cost. For patients sent to a community based SNF or RF, laboratory data were not available unless internally drawn or documented in the electronic medical record.

Additionally, not all cost data were available from VA sources; some were applied from literature, pharmacoeconomist, or best faith effort based on workflow. The cost data from third party contractors providing OPAT services to some BVAMC patients during the time frame of this analysis were not available. Due to its small sample size, outliers had the potential to affect averages reported and accuracy of the cost analysis. Emerging evidence suggests that daptomycin doses higher than the manufacturer-recommended regimen may be required for select indications, a factor that could affect cost, AEs, and efficacy outcomes.28 The acquisition cost of oritavancin and dalbavancin may vary by institution (ie, VA contract prices vs non- VA contract prices) and change over time. A current assessment of cost is needed to best visualize institutional benefit.

Finally, while the patient demographic of this MUE was highly representative of the demographic treated at the BVAMC (males aged >65 years), it may not be applicable to external patient populations. This analysis evaluated off-label indications for these medications. Consequently, this analysis would likely not be applicable to non-VA institution, as third-party payers (eg, insurance) are unlikely to cover medications for off-label indications.

CONCLUSIONS

This study found cost savings associated with the use of oritavancin and dalbavancin compared with vancomycin and daptomycin, particularly for the treatment of osteomyelitis. As safety and efficacy data continues to emerge, the use of long-acting lipoglycopeptides appears to be an increasingly attractive alternative option compared to traditional outpatient antimicrobial therapy, depending on the structure of the program. Larger, multicenter cost-effectiveness studies are needed to further establish the impact of these novel agents.

References
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  4. Simonetti O, Rizzetto G, Molinelli E, Cirioni O, Offidani A. Review: a safety profile of dalbavancin for on- and offlabel utilization. Ther Clin Risk Manag. 2021;17:223-232. doi:10.2147/TCRM.S271445
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  10. Cooper MM, Preslaski CR, Shihadeh KC, Hawkins KL, Jenkins TC. Multiple-dose dalbavancin regimens as the predominant treatment of deep-seated or endovascular infections: a scoping review. Open Forum Infect Dis. 2021;8(11):ofab486. doi:10.1093/ofid/ofab486
  11. Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis in adults: diagnosis, antimicrobial therapy, and management of complications: a scientific statement for healthcare professionals from the American Heart Association. Circulation. 2015;132(15):1435-1486. doi:10.1161/CIR.0000000000000296
  12. Berbari EF, Kanj SS, Kowalski TJ, et al. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015;61(6):e26-46. doi:10.1093/cid/civ482
  13. Arrieta-Loitegui M, Caro-Teller JM, Ortiz-Pérez S, López- Medrano F, San Juan-Garrido R, Ferrari-Piquero JM. Effectiveness, safety, and cost analysis of dalbavancin in clinical practice. Eur J Hosp Pharm. 2022;29(1):55-58. doi:10.1136/ejhpharm-2020-002315
  14. Pascale R, Maccaro A, Mikus E, et al. A retrospective multicentre study on dalbavancin effectiveness and cost-evaluation in sternotomic wound infection treatment: DALBA SWIT study. J Glob Antimicrob Resist. 2022;30:390-394. doi:10.1016/j.jgar.2022.07.018
  15. Antosz K, Al-Hasan MN, Lu ZK, et at. Clinical utility and cost effectiveness of long-acting lipoglycopeptides used in deep seated infections among patients with social and economic barriers to care. Pharmacy (Basel). 2021;10(1):1. doi:10.3390/pharmacy10010001
  16. Roberts MS. Economic aspects of evaluation. In: Friedman CP, Wyatt JC, eds. Evaluation Methods in Biomedical Informatics. 2nd ed. Springer; 2006:301-337.
  17. US Department of Veterans Affairs. HERC inpatient average cost data. Updated May 1, 2025. Accessed May 9, 2025. https://www.herc.research.va.gov/include/page.asp?id=inpatient
  18. US Department of Veterans Affairs. HERC Outpatient average cost dataset. Updated May 1, 2025. Accessed May 9, 2025. https://www.herc.research.va.gov/include/page.asp?id=outpatient
  19. Ektare V, Khachatryan A, Xue M, Dunne M, Johnson K, Stephens J. Assessing the economic value of avoiding hospital admissions by shifting the management of gram + acute bacterial skin and skin-structure infections to an outpatient care setting. J Med Econ. 2015;18(12):1092-1101. doi:10.3111/13696998.2015.1078339
  20. Ruh CA, Parameswaran GI, Wojciechowski AL, Mergenhagen KA. Outcomes and pharmacoeconomic analysis of a home intravenous antibiotic infusion program in veterans. Clin Ther. 2015;37(11):2527-2535. doi:10.1016/j.clinthera.2015.09.009
  21. Nakrani M, Yu D, Skikka M, et al. Comparison of vancomycin and daptomycin complications and interventions in outpatient parenteral antimicrobial therapy. Open Forum Infect Dis. 2020;7(Suppl 1):S361-S362. doi:10.1093/ofid/ofaa439.791
  22. Scoble PJ, Reilly J, Tilloston GS. Real-world use of oritavancin for the treatment of osteomyelitis. Drugs Real World Outcomes. 2020;7(Suppl 1):46-54. doi:10.1007/s40801-020-00194-8
  23. Segala D, Barbieri M, Di Nuzzo M, et al. Clinical, organizational, and pharmacoeconomic perspectives of dalbavancin vs standard of care in the infectious disease network. Glob Reg Health Technol Assess. 2024;11(Suppl 2):5-12. doi:10.33393/grhta.2024.3094
  24. Gómez A, et al. EN-DALBACEN 2.0 Cohort: real-life study of dalbavancin as sequential/consolidation therapy in patients with infective endocarditis due to Gram-positive cocci. Int J Antimicrob Agents. 2023;62(3):106918. doi:10.1016/j.ijantimicag.2023.106918
  25. LoVecchio F, McCarthy MW, Ye X, et al. Single intravenous dose dalbavancin pathway for the treatment of acute bacterial skin and skin structure infections: considerations for emergency department implementation and cost savings. J Emerg Med. 2024;67(2):e217-e229. doi:10.1016/j.jemermed.2024.03.003
  26. Gonzalez J, Andrade DC, Niu J. Cost-consequence analysis of single-dose dalbavancin versus standard of care for the treatment of acute bacterial skin and skin structure infections in a multisite healthcare system. Clin Infect Dis. 2021;73(7):e1436-e1442. doi:10.1093/cid/ciaa1732
  27. Turco NJ, Kane-Gill SL, Hernandez I, Oleksiuk LM, D’Amico F, Pickering AJ. A cost-minimization analysis of dalbavancin compared to conventional therapy for the outpatient treatment of acute bacterial skin and skin-structure infections. Expert Opin Pharmacother. 2018;19(4):319-325. doi:10.1080/14656566.2018.1442439
  28. Jones TW, Jun AH, Michal JL, Olney WJ. High-dose daptomycin and clinical applications. Ann Pharmacother. 2021;55(11):1363-1378. doi:10.1177/1060028021991943
References
  1. Dalvance. Package insert. AbbVie Inc.; 2025.
  2. Orbactiv. Package insert. Melinta Therapeutics; 2022.
  3. Cooper CC, Stein GE, Mitra S, Abubaker A, Havlichek DH. Long-acting lipoglycopeptides for the treatment of bone and joint infections. Surg Infect (Larchmt). 2021;22(8):771- 779. doi:10.1089/sur.2020.413
  4. Simonetti O, Rizzetto G, Molinelli E, Cirioni O, Offidani A. Review: a safety profile of dalbavancin for on- and offlabel utilization. Ther Clin Risk Manag. 2021;17:223-232. doi:10.2147/TCRM.S271445
  5. Bloem A, Bax HI, Yusuf E, Verkaik NJ. New-generation antibiotics for treatment of gram-positive infections: a review with focus on endocarditis and osteomyelitis. J Clin Med. 2021;10(8):1743. doi:10.3390/jcm10081743
  6. Thomas G, Henao-Martínez AF, Franco-Paredes C, Chastain DB. Treatment of osteoarticular, cardiovascular, intravascular-catheter-related and other complicated infections with dalbavancin and oritavancin: a systematic review. Int J Antimicrob Agents. 2020;56(3):106069. doi:10.1016/j.ijantimicag.2020.106069
  7. Rappo U, Puttagunta S, Shevchenko V, et al. Dalbavancin for the treatment of osteomyelitis in adult patients: a randomized clinical trial of efficacy and safety. Open Forum Infect Dis. 2018;6(1):ofy331. doi:10.1093/ofid/ofy331
  8. Cain AR, Bremmer DN, Carr DR, et al. Effectiveness of dalbavancin compared with standard of care for the treatment of osteomyelitis: a real-world analysis. Open Forum Infect Dis. 2021;9(2):ofab589. doi:10.1093/ofid/ofab589
  9. Van Hise NW, Chundi V, Didwania V, et al. Treatment of acute osteomyelitis with once-weekly oritavancin: a two-year, multicenter, retrospective study. Drugs Real World Outcomes. 2020;7(Suppl 1):41-45. doi:10.1007/s40801-020-00195-7
  10. Cooper MM, Preslaski CR, Shihadeh KC, Hawkins KL, Jenkins TC. Multiple-dose dalbavancin regimens as the predominant treatment of deep-seated or endovascular infections: a scoping review. Open Forum Infect Dis. 2021;8(11):ofab486. doi:10.1093/ofid/ofab486
  11. Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis in adults: diagnosis, antimicrobial therapy, and management of complications: a scientific statement for healthcare professionals from the American Heart Association. Circulation. 2015;132(15):1435-1486. doi:10.1161/CIR.0000000000000296
  12. Berbari EF, Kanj SS, Kowalski TJ, et al. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015;61(6):e26-46. doi:10.1093/cid/civ482
  13. Arrieta-Loitegui M, Caro-Teller JM, Ortiz-Pérez S, López- Medrano F, San Juan-Garrido R, Ferrari-Piquero JM. Effectiveness, safety, and cost analysis of dalbavancin in clinical practice. Eur J Hosp Pharm. 2022;29(1):55-58. doi:10.1136/ejhpharm-2020-002315
  14. Pascale R, Maccaro A, Mikus E, et al. A retrospective multicentre study on dalbavancin effectiveness and cost-evaluation in sternotomic wound infection treatment: DALBA SWIT study. J Glob Antimicrob Resist. 2022;30:390-394. doi:10.1016/j.jgar.2022.07.018
  15. Antosz K, Al-Hasan MN, Lu ZK, et at. Clinical utility and cost effectiveness of long-acting lipoglycopeptides used in deep seated infections among patients with social and economic barriers to care. Pharmacy (Basel). 2021;10(1):1. doi:10.3390/pharmacy10010001
  16. Roberts MS. Economic aspects of evaluation. In: Friedman CP, Wyatt JC, eds. Evaluation Methods in Biomedical Informatics. 2nd ed. Springer; 2006:301-337.
  17. US Department of Veterans Affairs. HERC inpatient average cost data. Updated May 1, 2025. Accessed May 9, 2025. https://www.herc.research.va.gov/include/page.asp?id=inpatient
  18. US Department of Veterans Affairs. HERC Outpatient average cost dataset. Updated May 1, 2025. Accessed May 9, 2025. https://www.herc.research.va.gov/include/page.asp?id=outpatient
  19. Ektare V, Khachatryan A, Xue M, Dunne M, Johnson K, Stephens J. Assessing the economic value of avoiding hospital admissions by shifting the management of gram + acute bacterial skin and skin-structure infections to an outpatient care setting. J Med Econ. 2015;18(12):1092-1101. doi:10.3111/13696998.2015.1078339
  20. Ruh CA, Parameswaran GI, Wojciechowski AL, Mergenhagen KA. Outcomes and pharmacoeconomic analysis of a home intravenous antibiotic infusion program in veterans. Clin Ther. 2015;37(11):2527-2535. doi:10.1016/j.clinthera.2015.09.009
  21. Nakrani M, Yu D, Skikka M, et al. Comparison of vancomycin and daptomycin complications and interventions in outpatient parenteral antimicrobial therapy. Open Forum Infect Dis. 2020;7(Suppl 1):S361-S362. doi:10.1093/ofid/ofaa439.791
  22. Scoble PJ, Reilly J, Tilloston GS. Real-world use of oritavancin for the treatment of osteomyelitis. Drugs Real World Outcomes. 2020;7(Suppl 1):46-54. doi:10.1007/s40801-020-00194-8
  23. Segala D, Barbieri M, Di Nuzzo M, et al. Clinical, organizational, and pharmacoeconomic perspectives of dalbavancin vs standard of care in the infectious disease network. Glob Reg Health Technol Assess. 2024;11(Suppl 2):5-12. doi:10.33393/grhta.2024.3094
  24. Gómez A, et al. EN-DALBACEN 2.0 Cohort: real-life study of dalbavancin as sequential/consolidation therapy in patients with infective endocarditis due to Gram-positive cocci. Int J Antimicrob Agents. 2023;62(3):106918. doi:10.1016/j.ijantimicag.2023.106918
  25. LoVecchio F, McCarthy MW, Ye X, et al. Single intravenous dose dalbavancin pathway for the treatment of acute bacterial skin and skin structure infections: considerations for emergency department implementation and cost savings. J Emerg Med. 2024;67(2):e217-e229. doi:10.1016/j.jemermed.2024.03.003
  26. Gonzalez J, Andrade DC, Niu J. Cost-consequence analysis of single-dose dalbavancin versus standard of care for the treatment of acute bacterial skin and skin structure infections in a multisite healthcare system. Clin Infect Dis. 2021;73(7):e1436-e1442. doi:10.1093/cid/ciaa1732
  27. Turco NJ, Kane-Gill SL, Hernandez I, Oleksiuk LM, D’Amico F, Pickering AJ. A cost-minimization analysis of dalbavancin compared to conventional therapy for the outpatient treatment of acute bacterial skin and skin-structure infections. Expert Opin Pharmacother. 2018;19(4):319-325. doi:10.1080/14656566.2018.1442439
  28. Jones TW, Jun AH, Michal JL, Olney WJ. High-dose daptomycin and clinical applications. Ann Pharmacother. 2021;55(11):1363-1378. doi:10.1177/1060028021991943
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Behavioral Health Trainee Satisfaction at the US Department of Veterans Affairs During the COVID-19 Pandemic

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Behavioral Health Trainee Satisfaction at the US Department of Veterans Affairs During the COVID-19 Pandemic

The COVID-19 pandemic changed the education and training experiences of health care students and those set to comprise the future workforce. Apart from general training disruptions or delays due to the pandemic, behavioral health trainees such as psychologists and social workers faced limited opportunities to provide in-person services.1-5 Trainees also experienced fewer referrals to mental health services from primary care and more disrupted, no-show, or cancelled appointments.4-6 Behavioral health trainees experienced a limited ability to establish rapport and more difficulty providing effective services because of the limited in-person interaction presented by telehealth.6 The pandemic also resulted in feelings of increased isolation and decreased teamwork.1,7 The virtual or remote setting made it more difficult for trainees to feel as if they were a member of a team or community of behavioral health professionals.1,7

Behavioral health trainees had to adapt to conducting patient visits and educational didactics through virtual platforms.1,3-7 Challenges included access or technological problems with online platforms and a lack of telehealth training use.3,4,6 One study found that while both behavioral health trainees and licensed practitioners reported similar rates of telehealth use for mental health services by early April 2020, trainees had more difficulties implementing telehealth compared with licensed practitioners. This study found that US Department of Veteran Affairs (VA) facilities reported higher use of telehealth in February 2020.5

A mission of the VA is to provide education and training to health care professionals through partnerships with affiliated academic institutions. The VA is the largest education and training supplier for health care professions in the US. As many as 50% of psychologists in the US received some training at the VA.8 Additionally, more graduate-level social work students are trained at the VA than at any other organization.9 The VA is a major contributor to not only its own behavioral health workforce, but that of the entire country.

The VA is also the largest employer of psychologists and social workers in the US.10,11 The VA Office of Academic Affiliations (OAA) oversees health care profession education and training at all VA facilities. In 2012, OAA began the Mental Health Education Expansion program to increase training for behavioral health professionals, including psychologists and social workers. 12 The OAA initiative was aligned with VA training and workforce priorities.8,12 To gauge the effectiveness of VA education and training, OAA encourages VA trainees to complete the Trainee Satisfaction Survey (TSS), which measures trainee satisfaction and the likelihood of a trainee to consider the VA for future employment.

Researchers at the Veterans Emergency Management Evaluation Center sought to understand the impact the COVID-19 pandemic had on behavioral health trainees’ experiences by examining TSS data from before and after the onset of the pandemic. This study expands on prior research among physician residents and fellows which found associations between VA training experiences and the COVID- 19 pandemic. The previous study found declines in trainee satisfaction and a decreased likelihood to consider the VA for future employment.13

It is important to understand the effects the pandemic had on the professional development and wellness for both physician and behavioral health professional trainees. Identifying how the pandemic impacted trainee satisfaction may help improve education programs and mitigate the impact of future public health emergencies. This is particularly important due to the shortage of behavioral health professionals in the VA and the US.12,14

METHODS

This study used TSS data collected from August 2018 to July 2021 from 153 VA facilities. A behavioral health trainee was defined as any psychology or social work trainee who completed 1 rotation at a VA facility. Psychiatric trainees were excluded because as physicians their training programs differ markedly from those for psychology and social work. Excluding psychiatry, psychology and social work comprise the 2 largest mental health care training groups.

This study was reviewed and approved as a quality improvement project by the VA Greater Los Angeles Healthcare System (VAGLAHS) Institutional Review Board, which waived informed consent requirements. The OAA granted access to data using a process open to all VA researchers. At the time of data collection, respondents were assured their anonymity; participation was voluntary.

Measures

Any response provided before February 29, 2020, was defined as the prepandemic period. The pandemic period included any response from April 1, 2020, to July 31, 2021. Responses collected in March 2020 were excluded as it would be unclear from the survey whether the training period occurred before or after the onset of the pandemic.

To measure overall trainee satisfaction with the VA training experience, responses were grouped as satisfied (satisfied/ very satisfied) and dissatisfied (dissatisfied/ very dissatisfied). To measure a trainee’s likelihood to consider the VA for future employment as a result of their training experience, responses were grouped as likely (likely/very likely) and unlikely (unlikely/very unlikely).

Other components of satisfaction were also collected including onboarding, clinical faculty/preceptors, clinical learning environment, physical environment, working environment, and respect felt at work. If a respondent chose very dissatisfied or dissatisfied, they were subsequently asked to specify the reason for their dissatisfaction with an open-ended response. Open-ended responses were not permitted if a respondent indicated a satisfied or very satisfied response.

Statistical Analyses

Stata SE 17 was used for statistical analyses. To test the relationship between the pandemic group and the 2 separate outcome variables, logistic regressions were conducted to measure overall satisfaction and likelihood of future VA employment. Margin commands were used to calculate the difference in the probability of reporting satisfied/very satisfied and likely/very likely for the prepandemic and pandemic groups. The association of the COVID-19 group with each outcome variable was expressed as the difference in the percentage of the outcome between the prepandemic and pandemic groups. Preliminary analyses demonstrated similar effects of the pandemic on psychology and social work trainees; therefore, the groups were combined.

Rapid Coding and Thematic Analyses

Qualitative data were based on open-ended responses from behavioral health trainees when they were asked to specify the cause of dissatisfaction in the aforementioned areas of satisfaction. Methods for qualitative data included rapid coding and thematic content analyses.15,16 Additional general information regarding the qualitative data analyses is described elsewhere.13 A keyword search was completed to identify all open-ended responses related to COVID-19 pandemic causes of dissatisfaction. Keywords included: virus, COVID, corona, pandemic, PPE, N95, mask, social distance, and safety. All open-ended responses were reviewed to ensure keywords were appropriately identifying pandemic-related causes of dissatisfaction and did not overlook other references to the pandemic, and to identify initial themes and corresponding definitions based on survey questions. After review, additional keywords were included in the content analyses that were related to providing mental health services using remote or telehealth options. This included the following keywords: remote, video, VVC (VA Video Connect), and tele. The research team completed a review of the initial themes and definitions and created a final coding construct with definitions before completing an independent coding of all identified pandemic-related responses. Frequency counts of each code were provided to identify which pandemic-related causes of dissatisfaction were mentioned most.

RESULTS

A total of 3950 behavioral health trainees responded to the TSS, including 2715 psychology trainees and 1235 social work trainees who indicated they received training at the VA in academic years 2018/2019, 2019/2020, or 2020/2021. The academic year 2018/2019 was considered in an effort to provide a larger sample of prepandemic trainees.

The percentage of trainees reporting satisfaction with their training decreased across prepandemic to pandemic groups. In the pandemic group, 2166 of 2324 respondents (93.2%) reported satisfaction compared to 1474 of 1555 (94.8%) in the prepandemic trainee group (P = .04; 95% CI, -3.10 to -0.08). There was no association between the pandemic group and behavioral health trainees’ reported willingness to consider the VA for future employment (Table 1). Preliminary analyses demonstrated similar effects of the pandemic on psychology and social work trainees, therefore the groups were combined, and overall effects were reported.

0625FED-eTrainee-T1
Pandemic-Related Dissatisfaction

Of the 3950 psychology and social work trainees who responded to the survey, 75 (1.9%) indicated dissatisfaction with their VA training experience using pandemic-related keywords. Open-ended responses were generally short (range, 1-32 words; median, 19 words). Qualitative analyses revealed 7 themes (Table 2).

0625FED-eTrainee-T2

The most frequently identified theme was challenges with onboarding. One respondent indicated the modified onboarding procedures in place due to the pandemic were difficult to understand and resulted in delays. Another frequently mentioned cause of dissatisfaction was limited work or office space and insufficient computer availability. This was often noted to relate to a lack of private space to conduct telehealth visits or computers that were not equipped to provide telehealth. Several respondents also noted technological issues when attempting to use VVC to provide telehealth.

Another common theme was that the pandemic diminished teamwork, generated feelings of isolation, and created unsupportive environments for trainees. For instance, some trainees indicated that COVID-19 decreased the inclusion of trainees as part of the regular staff groups and accordingly resulted in limited networking opportunities. Other causes of dissatisfaction included the pandemic’s impacts on the learning environment, such as decreases in patient volume, decreased diversity of patient cases, and a limited presence of faculty mentors. Several respondents indicated that the pandemic limited their caseloads and indicated that most patients were seen virtually. Open-ended responses from a few respondents indicated their training environments were noncompliant with social distancing, personal protective equipment requirements, or other safety guidelines.

DISCUSSION

This study illustrates the impact of the COVID-19 pandemic on the behavioral health trainee experience, which was expressed through decreased satisfaction with their clinical training at the VA. The narrative data indicated that the observed pandemic-related dissatisfaction was linked specifically to onboarding, a lack of safe and private workspaces and computers, as well as a lack of a supportive work environment.

Although the reported decrease in satisfaction was statistically significant, the effect size was not large. Additionally, while satisfaction did decrease, the trainees’ reported likelihood to consider the VA for future employment was not impacted. This may suggest psychologist and social work trainees’ perseverance and dedication to their chosen profession persisted despite the challenges presented by the pandemic. Furthermore, the qualitative data suggest potential ways to mitigate health care profession trainee challenges that can follow a crisis like the COVID-19 pandemic, although further study is warranted.

While narrative responses with pandemic-related keywords did indicate challenges specific to COVID-19 (ie, limited access to workspaces and/or computers equipped for telehealth), the overall frequency of pandemic-related responses was low. This may indicate these are institutional challenges trainees face independent of the pandemic. These findings warrant longterm attention to the satisfaction of psychology and social worker trainees’ during the pandemic. For example, additional training for the use of telehealth could be provided. One study indicated that < 61% of psychology postdoctoral fellows received telepsychology training during the pandemic, and of those who did receive training, less than half were satisfied with it.3

Similarly, strategies could be developed to ensure a more supportive learning and work environment, and provide additional networking opportunities for trainees, despite social distancing. Education specific to disaster response should be incorporated into behavioral health care professionals’ training, especially because behavioral health care professionals provided major contributions during the pandemic due to reported increases in mental health concerns (eg, anxiety and depression) during the period.7,17,18 As the pandemic progressed, policies and procedures were established or modified to address some of these concerns because they were not necessarily limited to trainees. For example, additional training resources were developed to support the use of various telehealth technologies, virtual resources were used more often for meetings, and supervisors developed more comfort and familiarity with how to manage in a virtual or hybrid environment.

Limitations

Although the TSS data provide a large national sample of behavioral health care trainees, it only includes VA trainees, and therefore may not be completely generalizable across health care. However, because many psychologists and social workers throughout the US train at the VA, and because the VA is the largest employer of practicing psychologists and social workers, understanding the impacts felt at the VA informs institutions nationally.8-11 The TSS has limited demographic data (eg, age, race, ethnicity, and sex), so it is unclear whether the respondent groups before and during the pandemic differed in ways that could relate to outcomes. The data also do not specify exact training dates; however, anecdotal evidence suggests respondents generally complete the survey close to the end of their training.

Additionally, open-ended narrative responses were only asked for replies that indicated dissatisfaction, precluding a more nuanced understanding of potential positive outcomes. Furthermore, the TSS is limited to questions about the trainees’ clinical experiences, but because the pandemic created many stressors, there may have been personal issues that affected their work. It is possible that changes in overall satisfaction may have been rooted in something outside of their clinical experience. Finally, the response rate for the TSS is consistently low both before and during the pandemic and includes a limited number of narrative responses.

CONCLUSIONS

The VA is an important contributor to the education, training, and composition of the behavioral health care workforce. A deeper understanding of the VA trainee experience is important to identify how to improve behavioral health care professional education and training. This is especially true as behavioral health care faces shortages within the VA and nationwide.8,12,19

This study reinforces research that found health care trainees experienced decreased learning opportunities and telehealth-related challenges during the COVID-19 pandemic. 13,20 Despite the observed decline in trainee satisfaction, the lack of a corresponding change in likelihood to seek employment with the VA is encouraging for VA efforts to maintain and grow its behavioral health care workforce and for similar efforts outside VA. This resilience may relate to the substantial prepandemic time invested in their professional development. Future studies should examine long term impacts of the pandemic on trainee’s clinical experience and whether the pipeline of behavioral health care workers declines over time as students that are earlier in their career paths instead chose other professions. Future research should also explore ways to improve professional development and wellness of behavioral health care trainees during disasters (eg, telehealth training, additional networking, and social support).

References
  1. Muddle S, Rettie H, Harris O, Lawes A, Robinson R. Trainee life under COVID-19: a systemic case report. J Fam Ther. 2022;44(2):239-249. doi:10.1111/1467-6427.12354
  2. Valenzuela J, Crosby LE, Harrison RR. Commentary: reflections on the COVID-19 pandemic and health disparities in pediatric psychology. J Pediatr Psychol. 2020;45(8):839- 841. doi:10.1093/jpepsy/jsaa063
  3. Frye WS, Feldman M, Katzenstein J, Gardner L. Modified training experiences for psychology interns and fellows during COVID-19: use of telepsychology and telesupervision by child and adolescent training programs. J Clin Psychol Med Settings. 2022;29(4):840- 848. doi:10.1007/s10880-021-09839-4
  4. Perrin PB, Rybarczyk BD, Pierce BS, Jones HA, Shaffer C, Islam L. Rapid telepsychology deployment during the COVID-19 pandemic: a special issue commentary and lessons from primary care psychology training. J Clin Psychol. 2020;76(6):1173-1185. doi:10.1002/jclp.22969
  5. Reilly SE, Zane KL, McCuddy WT, et al. Mental health practitioners’ immediate practical response during the COVID-19 pandemic: observational questionnaire study. JMIR Ment Health. 2020;7(9):e21237. doi:10.2196/21237
  6. Sadicario JS, Parlier-Ahmad AB, Brechbiel JK, Islam LZ, Martin CE. Caring for women with substance use disorders through pregnancy and postpartum during the COVID-19 pandemic: lessons learned from psychology trainees in an integrated OBGYN/substance use disorder outpatient treatment program. J Subst Abuse Treat. 2021;122:108200. doi:10.1016/j.jsat.2020.108200
  7. Schneider NM, Steinberg DM, Garcia AM, et al. Pediatric consultation-liaison psychology: insights and lessons learned during the COVID-19 pandemic. J Clin Psychol Med Settings. 2023;30(1):51-60. doi:10.1007/s10880-022-09887-4
  8. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee to Evaluate the Department of Veterans Affairs Mental Health. Mental Health Workforce and Facilities Infrastructure. In: Evaluation of the Department of Veterans Affairs Mental Health Services. National Academies Press (US); 2018. https://www.ncbi.nlm.nih.gov/books/NBK499512/
  9. U.S. Department of Veterans Affairs Veterans Health Administration. Career as a VA social worker. Updated March 3, 2025. Accessed May 6, 2025. https://www.socialwork.va.gov/VA_Employment.asp
  10. United States Senate Committee on Veterans Affairs hearing on “Making the VA the Workplace of Choice for Health Care Providers.” News release. American Psychological Association. April 9, 2008. Accessed April 9, 2025. https:// www.apa.org/news/press/releases/2008/04/testimony
  11. VA National Professional Social Work Month Planning Committee. The diverse, far-reaching VA social worker profession. March 17, 2023. Accessed April 9, 2025. https://news.va.gov/116804/diverse-far-reaching-social-worker-profession/
  12. Patel EL, Bates JM, Holguin JK, et al. Program profile: the expansion of associated health training in the VA. Fed Pract. 2021;38(8):374-380. doi:10.12788/fp.0163
  13. Northcraft H, Bai J, Griffin AR, Hovsepian S, Dobalian A. Association of the COVID-19 pandemic on VA resident and fellow training satisfaction and future VA employment: a mixed methods study. J Grad Med Educ. 2022;14(5):593- 598. doi:10.4300/JGME-D-22-00168.1
  14. Health Resources and Services Administration. Health workforce shortage areas. Accessed April 9, 2025. https://data.hrsa.gov/topics/health-workforce/shortage-areas
  15. Gale RC, Wu J, Erhardt T, et al. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019;14(1):11. doi:10.1186/s13012-019-0853-y
  16. Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018;8(10):e019993. doi:10.1136/bmjopen-2017-019993
  17. Kranke D, Der-Martirosian C, Hovsepian S, et al. Social workers being effective in disaster settings. Soc Work Public Health. 2020;35(8):664-668. doi:10.1080/19371918.20 20.1820928
  18. Kranke D, Gin JL, Der-Martirosian C, Weiss EL, Dobalian A. VA social work leadership and compassion fatigue during the 2017 hurricane season. Soc Work Ment Health. 2020;18:188-199. doi:10.1080/15332985.2019.1700873
  19. Health Resources and Services Administration. Workforce projections. Accessed April 9, 2025. https://data.hrsa.gov/topics/health-workforce/workforce-projections
  20. Der-Martirosian C, Wyte-Lake T, Balut M, et al. Implementation of telehealth services at the US Department of Veterans Affairs during the COVID-19 pandemic: mixed methods study. JMIR Form Res. 2021;5(9):e29429. doi:10.2196/29429
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Heather Northcraft, MAa; Jia Bai, MPHa; Anne R. Griffin, RN, MPHa; Aram Dobalian, PhD, JD, MPHa,b

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bThe Ohio State University, Columbus

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Correspondence: Heather Northcraft (heather.northcraft@va.gov)

Fed Pract. 2025;42(6):e0590. Published online June 16. doi:10.12788/fp.0590

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Correspondence: Heather Northcraft (heather.northcraft@va.gov)

Fed Pract. 2025;42(6):e0590. Published online June 16. doi:10.12788/fp.0590

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Author affiliations
aVeterans Affairs Greater Los Angeles Healthcare System, California
bThe Ohio State University, Columbus

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Heather Northcraft (heather.northcraft@va.gov)

Fed Pract. 2025;42(6):e0590. Published online June 16. doi:10.12788/fp.0590

Article PDF
Article PDF

The COVID-19 pandemic changed the education and training experiences of health care students and those set to comprise the future workforce. Apart from general training disruptions or delays due to the pandemic, behavioral health trainees such as psychologists and social workers faced limited opportunities to provide in-person services.1-5 Trainees also experienced fewer referrals to mental health services from primary care and more disrupted, no-show, or cancelled appointments.4-6 Behavioral health trainees experienced a limited ability to establish rapport and more difficulty providing effective services because of the limited in-person interaction presented by telehealth.6 The pandemic also resulted in feelings of increased isolation and decreased teamwork.1,7 The virtual or remote setting made it more difficult for trainees to feel as if they were a member of a team or community of behavioral health professionals.1,7

Behavioral health trainees had to adapt to conducting patient visits and educational didactics through virtual platforms.1,3-7 Challenges included access or technological problems with online platforms and a lack of telehealth training use.3,4,6 One study found that while both behavioral health trainees and licensed practitioners reported similar rates of telehealth use for mental health services by early April 2020, trainees had more difficulties implementing telehealth compared with licensed practitioners. This study found that US Department of Veteran Affairs (VA) facilities reported higher use of telehealth in February 2020.5

A mission of the VA is to provide education and training to health care professionals through partnerships with affiliated academic institutions. The VA is the largest education and training supplier for health care professions in the US. As many as 50% of psychologists in the US received some training at the VA.8 Additionally, more graduate-level social work students are trained at the VA than at any other organization.9 The VA is a major contributor to not only its own behavioral health workforce, but that of the entire country.

The VA is also the largest employer of psychologists and social workers in the US.10,11 The VA Office of Academic Affiliations (OAA) oversees health care profession education and training at all VA facilities. In 2012, OAA began the Mental Health Education Expansion program to increase training for behavioral health professionals, including psychologists and social workers. 12 The OAA initiative was aligned with VA training and workforce priorities.8,12 To gauge the effectiveness of VA education and training, OAA encourages VA trainees to complete the Trainee Satisfaction Survey (TSS), which measures trainee satisfaction and the likelihood of a trainee to consider the VA for future employment.

Researchers at the Veterans Emergency Management Evaluation Center sought to understand the impact the COVID-19 pandemic had on behavioral health trainees’ experiences by examining TSS data from before and after the onset of the pandemic. This study expands on prior research among physician residents and fellows which found associations between VA training experiences and the COVID- 19 pandemic. The previous study found declines in trainee satisfaction and a decreased likelihood to consider the VA for future employment.13

It is important to understand the effects the pandemic had on the professional development and wellness for both physician and behavioral health professional trainees. Identifying how the pandemic impacted trainee satisfaction may help improve education programs and mitigate the impact of future public health emergencies. This is particularly important due to the shortage of behavioral health professionals in the VA and the US.12,14

METHODS

This study used TSS data collected from August 2018 to July 2021 from 153 VA facilities. A behavioral health trainee was defined as any psychology or social work trainee who completed 1 rotation at a VA facility. Psychiatric trainees were excluded because as physicians their training programs differ markedly from those for psychology and social work. Excluding psychiatry, psychology and social work comprise the 2 largest mental health care training groups.

This study was reviewed and approved as a quality improvement project by the VA Greater Los Angeles Healthcare System (VAGLAHS) Institutional Review Board, which waived informed consent requirements. The OAA granted access to data using a process open to all VA researchers. At the time of data collection, respondents were assured their anonymity; participation was voluntary.

Measures

Any response provided before February 29, 2020, was defined as the prepandemic period. The pandemic period included any response from April 1, 2020, to July 31, 2021. Responses collected in March 2020 were excluded as it would be unclear from the survey whether the training period occurred before or after the onset of the pandemic.

To measure overall trainee satisfaction with the VA training experience, responses were grouped as satisfied (satisfied/ very satisfied) and dissatisfied (dissatisfied/ very dissatisfied). To measure a trainee’s likelihood to consider the VA for future employment as a result of their training experience, responses were grouped as likely (likely/very likely) and unlikely (unlikely/very unlikely).

Other components of satisfaction were also collected including onboarding, clinical faculty/preceptors, clinical learning environment, physical environment, working environment, and respect felt at work. If a respondent chose very dissatisfied or dissatisfied, they were subsequently asked to specify the reason for their dissatisfaction with an open-ended response. Open-ended responses were not permitted if a respondent indicated a satisfied or very satisfied response.

Statistical Analyses

Stata SE 17 was used for statistical analyses. To test the relationship between the pandemic group and the 2 separate outcome variables, logistic regressions were conducted to measure overall satisfaction and likelihood of future VA employment. Margin commands were used to calculate the difference in the probability of reporting satisfied/very satisfied and likely/very likely for the prepandemic and pandemic groups. The association of the COVID-19 group with each outcome variable was expressed as the difference in the percentage of the outcome between the prepandemic and pandemic groups. Preliminary analyses demonstrated similar effects of the pandemic on psychology and social work trainees; therefore, the groups were combined.

Rapid Coding and Thematic Analyses

Qualitative data were based on open-ended responses from behavioral health trainees when they were asked to specify the cause of dissatisfaction in the aforementioned areas of satisfaction. Methods for qualitative data included rapid coding and thematic content analyses.15,16 Additional general information regarding the qualitative data analyses is described elsewhere.13 A keyword search was completed to identify all open-ended responses related to COVID-19 pandemic causes of dissatisfaction. Keywords included: virus, COVID, corona, pandemic, PPE, N95, mask, social distance, and safety. All open-ended responses were reviewed to ensure keywords were appropriately identifying pandemic-related causes of dissatisfaction and did not overlook other references to the pandemic, and to identify initial themes and corresponding definitions based on survey questions. After review, additional keywords were included in the content analyses that were related to providing mental health services using remote or telehealth options. This included the following keywords: remote, video, VVC (VA Video Connect), and tele. The research team completed a review of the initial themes and definitions and created a final coding construct with definitions before completing an independent coding of all identified pandemic-related responses. Frequency counts of each code were provided to identify which pandemic-related causes of dissatisfaction were mentioned most.

RESULTS

A total of 3950 behavioral health trainees responded to the TSS, including 2715 psychology trainees and 1235 social work trainees who indicated they received training at the VA in academic years 2018/2019, 2019/2020, or 2020/2021. The academic year 2018/2019 was considered in an effort to provide a larger sample of prepandemic trainees.

The percentage of trainees reporting satisfaction with their training decreased across prepandemic to pandemic groups. In the pandemic group, 2166 of 2324 respondents (93.2%) reported satisfaction compared to 1474 of 1555 (94.8%) in the prepandemic trainee group (P = .04; 95% CI, -3.10 to -0.08). There was no association between the pandemic group and behavioral health trainees’ reported willingness to consider the VA for future employment (Table 1). Preliminary analyses demonstrated similar effects of the pandemic on psychology and social work trainees, therefore the groups were combined, and overall effects were reported.

0625FED-eTrainee-T1
Pandemic-Related Dissatisfaction

Of the 3950 psychology and social work trainees who responded to the survey, 75 (1.9%) indicated dissatisfaction with their VA training experience using pandemic-related keywords. Open-ended responses were generally short (range, 1-32 words; median, 19 words). Qualitative analyses revealed 7 themes (Table 2).

0625FED-eTrainee-T2

The most frequently identified theme was challenges with onboarding. One respondent indicated the modified onboarding procedures in place due to the pandemic were difficult to understand and resulted in delays. Another frequently mentioned cause of dissatisfaction was limited work or office space and insufficient computer availability. This was often noted to relate to a lack of private space to conduct telehealth visits or computers that were not equipped to provide telehealth. Several respondents also noted technological issues when attempting to use VVC to provide telehealth.

Another common theme was that the pandemic diminished teamwork, generated feelings of isolation, and created unsupportive environments for trainees. For instance, some trainees indicated that COVID-19 decreased the inclusion of trainees as part of the regular staff groups and accordingly resulted in limited networking opportunities. Other causes of dissatisfaction included the pandemic’s impacts on the learning environment, such as decreases in patient volume, decreased diversity of patient cases, and a limited presence of faculty mentors. Several respondents indicated that the pandemic limited their caseloads and indicated that most patients were seen virtually. Open-ended responses from a few respondents indicated their training environments were noncompliant with social distancing, personal protective equipment requirements, or other safety guidelines.

DISCUSSION

This study illustrates the impact of the COVID-19 pandemic on the behavioral health trainee experience, which was expressed through decreased satisfaction with their clinical training at the VA. The narrative data indicated that the observed pandemic-related dissatisfaction was linked specifically to onboarding, a lack of safe and private workspaces and computers, as well as a lack of a supportive work environment.

Although the reported decrease in satisfaction was statistically significant, the effect size was not large. Additionally, while satisfaction did decrease, the trainees’ reported likelihood to consider the VA for future employment was not impacted. This may suggest psychologist and social work trainees’ perseverance and dedication to their chosen profession persisted despite the challenges presented by the pandemic. Furthermore, the qualitative data suggest potential ways to mitigate health care profession trainee challenges that can follow a crisis like the COVID-19 pandemic, although further study is warranted.

While narrative responses with pandemic-related keywords did indicate challenges specific to COVID-19 (ie, limited access to workspaces and/or computers equipped for telehealth), the overall frequency of pandemic-related responses was low. This may indicate these are institutional challenges trainees face independent of the pandemic. These findings warrant longterm attention to the satisfaction of psychology and social worker trainees’ during the pandemic. For example, additional training for the use of telehealth could be provided. One study indicated that < 61% of psychology postdoctoral fellows received telepsychology training during the pandemic, and of those who did receive training, less than half were satisfied with it.3

Similarly, strategies could be developed to ensure a more supportive learning and work environment, and provide additional networking opportunities for trainees, despite social distancing. Education specific to disaster response should be incorporated into behavioral health care professionals’ training, especially because behavioral health care professionals provided major contributions during the pandemic due to reported increases in mental health concerns (eg, anxiety and depression) during the period.7,17,18 As the pandemic progressed, policies and procedures were established or modified to address some of these concerns because they were not necessarily limited to trainees. For example, additional training resources were developed to support the use of various telehealth technologies, virtual resources were used more often for meetings, and supervisors developed more comfort and familiarity with how to manage in a virtual or hybrid environment.

Limitations

Although the TSS data provide a large national sample of behavioral health care trainees, it only includes VA trainees, and therefore may not be completely generalizable across health care. However, because many psychologists and social workers throughout the US train at the VA, and because the VA is the largest employer of practicing psychologists and social workers, understanding the impacts felt at the VA informs institutions nationally.8-11 The TSS has limited demographic data (eg, age, race, ethnicity, and sex), so it is unclear whether the respondent groups before and during the pandemic differed in ways that could relate to outcomes. The data also do not specify exact training dates; however, anecdotal evidence suggests respondents generally complete the survey close to the end of their training.

Additionally, open-ended narrative responses were only asked for replies that indicated dissatisfaction, precluding a more nuanced understanding of potential positive outcomes. Furthermore, the TSS is limited to questions about the trainees’ clinical experiences, but because the pandemic created many stressors, there may have been personal issues that affected their work. It is possible that changes in overall satisfaction may have been rooted in something outside of their clinical experience. Finally, the response rate for the TSS is consistently low both before and during the pandemic and includes a limited number of narrative responses.

CONCLUSIONS

The VA is an important contributor to the education, training, and composition of the behavioral health care workforce. A deeper understanding of the VA trainee experience is important to identify how to improve behavioral health care professional education and training. This is especially true as behavioral health care faces shortages within the VA and nationwide.8,12,19

This study reinforces research that found health care trainees experienced decreased learning opportunities and telehealth-related challenges during the COVID-19 pandemic. 13,20 Despite the observed decline in trainee satisfaction, the lack of a corresponding change in likelihood to seek employment with the VA is encouraging for VA efforts to maintain and grow its behavioral health care workforce and for similar efforts outside VA. This resilience may relate to the substantial prepandemic time invested in their professional development. Future studies should examine long term impacts of the pandemic on trainee’s clinical experience and whether the pipeline of behavioral health care workers declines over time as students that are earlier in their career paths instead chose other professions. Future research should also explore ways to improve professional development and wellness of behavioral health care trainees during disasters (eg, telehealth training, additional networking, and social support).

The COVID-19 pandemic changed the education and training experiences of health care students and those set to comprise the future workforce. Apart from general training disruptions or delays due to the pandemic, behavioral health trainees such as psychologists and social workers faced limited opportunities to provide in-person services.1-5 Trainees also experienced fewer referrals to mental health services from primary care and more disrupted, no-show, or cancelled appointments.4-6 Behavioral health trainees experienced a limited ability to establish rapport and more difficulty providing effective services because of the limited in-person interaction presented by telehealth.6 The pandemic also resulted in feelings of increased isolation and decreased teamwork.1,7 The virtual or remote setting made it more difficult for trainees to feel as if they were a member of a team or community of behavioral health professionals.1,7

Behavioral health trainees had to adapt to conducting patient visits and educational didactics through virtual platforms.1,3-7 Challenges included access or technological problems with online platforms and a lack of telehealth training use.3,4,6 One study found that while both behavioral health trainees and licensed practitioners reported similar rates of telehealth use for mental health services by early April 2020, trainees had more difficulties implementing telehealth compared with licensed practitioners. This study found that US Department of Veteran Affairs (VA) facilities reported higher use of telehealth in February 2020.5

A mission of the VA is to provide education and training to health care professionals through partnerships with affiliated academic institutions. The VA is the largest education and training supplier for health care professions in the US. As many as 50% of psychologists in the US received some training at the VA.8 Additionally, more graduate-level social work students are trained at the VA than at any other organization.9 The VA is a major contributor to not only its own behavioral health workforce, but that of the entire country.

The VA is also the largest employer of psychologists and social workers in the US.10,11 The VA Office of Academic Affiliations (OAA) oversees health care profession education and training at all VA facilities. In 2012, OAA began the Mental Health Education Expansion program to increase training for behavioral health professionals, including psychologists and social workers. 12 The OAA initiative was aligned with VA training and workforce priorities.8,12 To gauge the effectiveness of VA education and training, OAA encourages VA trainees to complete the Trainee Satisfaction Survey (TSS), which measures trainee satisfaction and the likelihood of a trainee to consider the VA for future employment.

Researchers at the Veterans Emergency Management Evaluation Center sought to understand the impact the COVID-19 pandemic had on behavioral health trainees’ experiences by examining TSS data from before and after the onset of the pandemic. This study expands on prior research among physician residents and fellows which found associations between VA training experiences and the COVID- 19 pandemic. The previous study found declines in trainee satisfaction and a decreased likelihood to consider the VA for future employment.13

It is important to understand the effects the pandemic had on the professional development and wellness for both physician and behavioral health professional trainees. Identifying how the pandemic impacted trainee satisfaction may help improve education programs and mitigate the impact of future public health emergencies. This is particularly important due to the shortage of behavioral health professionals in the VA and the US.12,14

METHODS

This study used TSS data collected from August 2018 to July 2021 from 153 VA facilities. A behavioral health trainee was defined as any psychology or social work trainee who completed 1 rotation at a VA facility. Psychiatric trainees were excluded because as physicians their training programs differ markedly from those for psychology and social work. Excluding psychiatry, psychology and social work comprise the 2 largest mental health care training groups.

This study was reviewed and approved as a quality improvement project by the VA Greater Los Angeles Healthcare System (VAGLAHS) Institutional Review Board, which waived informed consent requirements. The OAA granted access to data using a process open to all VA researchers. At the time of data collection, respondents were assured their anonymity; participation was voluntary.

Measures

Any response provided before February 29, 2020, was defined as the prepandemic period. The pandemic period included any response from April 1, 2020, to July 31, 2021. Responses collected in March 2020 were excluded as it would be unclear from the survey whether the training period occurred before or after the onset of the pandemic.

To measure overall trainee satisfaction with the VA training experience, responses were grouped as satisfied (satisfied/ very satisfied) and dissatisfied (dissatisfied/ very dissatisfied). To measure a trainee’s likelihood to consider the VA for future employment as a result of their training experience, responses were grouped as likely (likely/very likely) and unlikely (unlikely/very unlikely).

Other components of satisfaction were also collected including onboarding, clinical faculty/preceptors, clinical learning environment, physical environment, working environment, and respect felt at work. If a respondent chose very dissatisfied or dissatisfied, they were subsequently asked to specify the reason for their dissatisfaction with an open-ended response. Open-ended responses were not permitted if a respondent indicated a satisfied or very satisfied response.

Statistical Analyses

Stata SE 17 was used for statistical analyses. To test the relationship between the pandemic group and the 2 separate outcome variables, logistic regressions were conducted to measure overall satisfaction and likelihood of future VA employment. Margin commands were used to calculate the difference in the probability of reporting satisfied/very satisfied and likely/very likely for the prepandemic and pandemic groups. The association of the COVID-19 group with each outcome variable was expressed as the difference in the percentage of the outcome between the prepandemic and pandemic groups. Preliminary analyses demonstrated similar effects of the pandemic on psychology and social work trainees; therefore, the groups were combined.

Rapid Coding and Thematic Analyses

Qualitative data were based on open-ended responses from behavioral health trainees when they were asked to specify the cause of dissatisfaction in the aforementioned areas of satisfaction. Methods for qualitative data included rapid coding and thematic content analyses.15,16 Additional general information regarding the qualitative data analyses is described elsewhere.13 A keyword search was completed to identify all open-ended responses related to COVID-19 pandemic causes of dissatisfaction. Keywords included: virus, COVID, corona, pandemic, PPE, N95, mask, social distance, and safety. All open-ended responses were reviewed to ensure keywords were appropriately identifying pandemic-related causes of dissatisfaction and did not overlook other references to the pandemic, and to identify initial themes and corresponding definitions based on survey questions. After review, additional keywords were included in the content analyses that were related to providing mental health services using remote or telehealth options. This included the following keywords: remote, video, VVC (VA Video Connect), and tele. The research team completed a review of the initial themes and definitions and created a final coding construct with definitions before completing an independent coding of all identified pandemic-related responses. Frequency counts of each code were provided to identify which pandemic-related causes of dissatisfaction were mentioned most.

RESULTS

A total of 3950 behavioral health trainees responded to the TSS, including 2715 psychology trainees and 1235 social work trainees who indicated they received training at the VA in academic years 2018/2019, 2019/2020, or 2020/2021. The academic year 2018/2019 was considered in an effort to provide a larger sample of prepandemic trainees.

The percentage of trainees reporting satisfaction with their training decreased across prepandemic to pandemic groups. In the pandemic group, 2166 of 2324 respondents (93.2%) reported satisfaction compared to 1474 of 1555 (94.8%) in the prepandemic trainee group (P = .04; 95% CI, -3.10 to -0.08). There was no association between the pandemic group and behavioral health trainees’ reported willingness to consider the VA for future employment (Table 1). Preliminary analyses demonstrated similar effects of the pandemic on psychology and social work trainees, therefore the groups were combined, and overall effects were reported.

0625FED-eTrainee-T1
Pandemic-Related Dissatisfaction

Of the 3950 psychology and social work trainees who responded to the survey, 75 (1.9%) indicated dissatisfaction with their VA training experience using pandemic-related keywords. Open-ended responses were generally short (range, 1-32 words; median, 19 words). Qualitative analyses revealed 7 themes (Table 2).

0625FED-eTrainee-T2

The most frequently identified theme was challenges with onboarding. One respondent indicated the modified onboarding procedures in place due to the pandemic were difficult to understand and resulted in delays. Another frequently mentioned cause of dissatisfaction was limited work or office space and insufficient computer availability. This was often noted to relate to a lack of private space to conduct telehealth visits or computers that were not equipped to provide telehealth. Several respondents also noted technological issues when attempting to use VVC to provide telehealth.

Another common theme was that the pandemic diminished teamwork, generated feelings of isolation, and created unsupportive environments for trainees. For instance, some trainees indicated that COVID-19 decreased the inclusion of trainees as part of the regular staff groups and accordingly resulted in limited networking opportunities. Other causes of dissatisfaction included the pandemic’s impacts on the learning environment, such as decreases in patient volume, decreased diversity of patient cases, and a limited presence of faculty mentors. Several respondents indicated that the pandemic limited their caseloads and indicated that most patients were seen virtually. Open-ended responses from a few respondents indicated their training environments were noncompliant with social distancing, personal protective equipment requirements, or other safety guidelines.

DISCUSSION

This study illustrates the impact of the COVID-19 pandemic on the behavioral health trainee experience, which was expressed through decreased satisfaction with their clinical training at the VA. The narrative data indicated that the observed pandemic-related dissatisfaction was linked specifically to onboarding, a lack of safe and private workspaces and computers, as well as a lack of a supportive work environment.

Although the reported decrease in satisfaction was statistically significant, the effect size was not large. Additionally, while satisfaction did decrease, the trainees’ reported likelihood to consider the VA for future employment was not impacted. This may suggest psychologist and social work trainees’ perseverance and dedication to their chosen profession persisted despite the challenges presented by the pandemic. Furthermore, the qualitative data suggest potential ways to mitigate health care profession trainee challenges that can follow a crisis like the COVID-19 pandemic, although further study is warranted.

While narrative responses with pandemic-related keywords did indicate challenges specific to COVID-19 (ie, limited access to workspaces and/or computers equipped for telehealth), the overall frequency of pandemic-related responses was low. This may indicate these are institutional challenges trainees face independent of the pandemic. These findings warrant longterm attention to the satisfaction of psychology and social worker trainees’ during the pandemic. For example, additional training for the use of telehealth could be provided. One study indicated that < 61% of psychology postdoctoral fellows received telepsychology training during the pandemic, and of those who did receive training, less than half were satisfied with it.3

Similarly, strategies could be developed to ensure a more supportive learning and work environment, and provide additional networking opportunities for trainees, despite social distancing. Education specific to disaster response should be incorporated into behavioral health care professionals’ training, especially because behavioral health care professionals provided major contributions during the pandemic due to reported increases in mental health concerns (eg, anxiety and depression) during the period.7,17,18 As the pandemic progressed, policies and procedures were established or modified to address some of these concerns because they were not necessarily limited to trainees. For example, additional training resources were developed to support the use of various telehealth technologies, virtual resources were used more often for meetings, and supervisors developed more comfort and familiarity with how to manage in a virtual or hybrid environment.

Limitations

Although the TSS data provide a large national sample of behavioral health care trainees, it only includes VA trainees, and therefore may not be completely generalizable across health care. However, because many psychologists and social workers throughout the US train at the VA, and because the VA is the largest employer of practicing psychologists and social workers, understanding the impacts felt at the VA informs institutions nationally.8-11 The TSS has limited demographic data (eg, age, race, ethnicity, and sex), so it is unclear whether the respondent groups before and during the pandemic differed in ways that could relate to outcomes. The data also do not specify exact training dates; however, anecdotal evidence suggests respondents generally complete the survey close to the end of their training.

Additionally, open-ended narrative responses were only asked for replies that indicated dissatisfaction, precluding a more nuanced understanding of potential positive outcomes. Furthermore, the TSS is limited to questions about the trainees’ clinical experiences, but because the pandemic created many stressors, there may have been personal issues that affected their work. It is possible that changes in overall satisfaction may have been rooted in something outside of their clinical experience. Finally, the response rate for the TSS is consistently low both before and during the pandemic and includes a limited number of narrative responses.

CONCLUSIONS

The VA is an important contributor to the education, training, and composition of the behavioral health care workforce. A deeper understanding of the VA trainee experience is important to identify how to improve behavioral health care professional education and training. This is especially true as behavioral health care faces shortages within the VA and nationwide.8,12,19

This study reinforces research that found health care trainees experienced decreased learning opportunities and telehealth-related challenges during the COVID-19 pandemic. 13,20 Despite the observed decline in trainee satisfaction, the lack of a corresponding change in likelihood to seek employment with the VA is encouraging for VA efforts to maintain and grow its behavioral health care workforce and for similar efforts outside VA. This resilience may relate to the substantial prepandemic time invested in their professional development. Future studies should examine long term impacts of the pandemic on trainee’s clinical experience and whether the pipeline of behavioral health care workers declines over time as students that are earlier in their career paths instead chose other professions. Future research should also explore ways to improve professional development and wellness of behavioral health care trainees during disasters (eg, telehealth training, additional networking, and social support).

References
  1. Muddle S, Rettie H, Harris O, Lawes A, Robinson R. Trainee life under COVID-19: a systemic case report. J Fam Ther. 2022;44(2):239-249. doi:10.1111/1467-6427.12354
  2. Valenzuela J, Crosby LE, Harrison RR. Commentary: reflections on the COVID-19 pandemic and health disparities in pediatric psychology. J Pediatr Psychol. 2020;45(8):839- 841. doi:10.1093/jpepsy/jsaa063
  3. Frye WS, Feldman M, Katzenstein J, Gardner L. Modified training experiences for psychology interns and fellows during COVID-19: use of telepsychology and telesupervision by child and adolescent training programs. J Clin Psychol Med Settings. 2022;29(4):840- 848. doi:10.1007/s10880-021-09839-4
  4. Perrin PB, Rybarczyk BD, Pierce BS, Jones HA, Shaffer C, Islam L. Rapid telepsychology deployment during the COVID-19 pandemic: a special issue commentary and lessons from primary care psychology training. J Clin Psychol. 2020;76(6):1173-1185. doi:10.1002/jclp.22969
  5. Reilly SE, Zane KL, McCuddy WT, et al. Mental health practitioners’ immediate practical response during the COVID-19 pandemic: observational questionnaire study. JMIR Ment Health. 2020;7(9):e21237. doi:10.2196/21237
  6. Sadicario JS, Parlier-Ahmad AB, Brechbiel JK, Islam LZ, Martin CE. Caring for women with substance use disorders through pregnancy and postpartum during the COVID-19 pandemic: lessons learned from psychology trainees in an integrated OBGYN/substance use disorder outpatient treatment program. J Subst Abuse Treat. 2021;122:108200. doi:10.1016/j.jsat.2020.108200
  7. Schneider NM, Steinberg DM, Garcia AM, et al. Pediatric consultation-liaison psychology: insights and lessons learned during the COVID-19 pandemic. J Clin Psychol Med Settings. 2023;30(1):51-60. doi:10.1007/s10880-022-09887-4
  8. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee to Evaluate the Department of Veterans Affairs Mental Health. Mental Health Workforce and Facilities Infrastructure. In: Evaluation of the Department of Veterans Affairs Mental Health Services. National Academies Press (US); 2018. https://www.ncbi.nlm.nih.gov/books/NBK499512/
  9. U.S. Department of Veterans Affairs Veterans Health Administration. Career as a VA social worker. Updated March 3, 2025. Accessed May 6, 2025. https://www.socialwork.va.gov/VA_Employment.asp
  10. United States Senate Committee on Veterans Affairs hearing on “Making the VA the Workplace of Choice for Health Care Providers.” News release. American Psychological Association. April 9, 2008. Accessed April 9, 2025. https:// www.apa.org/news/press/releases/2008/04/testimony
  11. VA National Professional Social Work Month Planning Committee. The diverse, far-reaching VA social worker profession. March 17, 2023. Accessed April 9, 2025. https://news.va.gov/116804/diverse-far-reaching-social-worker-profession/
  12. Patel EL, Bates JM, Holguin JK, et al. Program profile: the expansion of associated health training in the VA. Fed Pract. 2021;38(8):374-380. doi:10.12788/fp.0163
  13. Northcraft H, Bai J, Griffin AR, Hovsepian S, Dobalian A. Association of the COVID-19 pandemic on VA resident and fellow training satisfaction and future VA employment: a mixed methods study. J Grad Med Educ. 2022;14(5):593- 598. doi:10.4300/JGME-D-22-00168.1
  14. Health Resources and Services Administration. Health workforce shortage areas. Accessed April 9, 2025. https://data.hrsa.gov/topics/health-workforce/shortage-areas
  15. Gale RC, Wu J, Erhardt T, et al. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019;14(1):11. doi:10.1186/s13012-019-0853-y
  16. Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018;8(10):e019993. doi:10.1136/bmjopen-2017-019993
  17. Kranke D, Der-Martirosian C, Hovsepian S, et al. Social workers being effective in disaster settings. Soc Work Public Health. 2020;35(8):664-668. doi:10.1080/19371918.20 20.1820928
  18. Kranke D, Gin JL, Der-Martirosian C, Weiss EL, Dobalian A. VA social work leadership and compassion fatigue during the 2017 hurricane season. Soc Work Ment Health. 2020;18:188-199. doi:10.1080/15332985.2019.1700873
  19. Health Resources and Services Administration. Workforce projections. Accessed April 9, 2025. https://data.hrsa.gov/topics/health-workforce/workforce-projections
  20. Der-Martirosian C, Wyte-Lake T, Balut M, et al. Implementation of telehealth services at the US Department of Veterans Affairs during the COVID-19 pandemic: mixed methods study. JMIR Form Res. 2021;5(9):e29429. doi:10.2196/29429
References
  1. Muddle S, Rettie H, Harris O, Lawes A, Robinson R. Trainee life under COVID-19: a systemic case report. J Fam Ther. 2022;44(2):239-249. doi:10.1111/1467-6427.12354
  2. Valenzuela J, Crosby LE, Harrison RR. Commentary: reflections on the COVID-19 pandemic and health disparities in pediatric psychology. J Pediatr Psychol. 2020;45(8):839- 841. doi:10.1093/jpepsy/jsaa063
  3. Frye WS, Feldman M, Katzenstein J, Gardner L. Modified training experiences for psychology interns and fellows during COVID-19: use of telepsychology and telesupervision by child and adolescent training programs. J Clin Psychol Med Settings. 2022;29(4):840- 848. doi:10.1007/s10880-021-09839-4
  4. Perrin PB, Rybarczyk BD, Pierce BS, Jones HA, Shaffer C, Islam L. Rapid telepsychology deployment during the COVID-19 pandemic: a special issue commentary and lessons from primary care psychology training. J Clin Psychol. 2020;76(6):1173-1185. doi:10.1002/jclp.22969
  5. Reilly SE, Zane KL, McCuddy WT, et al. Mental health practitioners’ immediate practical response during the COVID-19 pandemic: observational questionnaire study. JMIR Ment Health. 2020;7(9):e21237. doi:10.2196/21237
  6. Sadicario JS, Parlier-Ahmad AB, Brechbiel JK, Islam LZ, Martin CE. Caring for women with substance use disorders through pregnancy and postpartum during the COVID-19 pandemic: lessons learned from psychology trainees in an integrated OBGYN/substance use disorder outpatient treatment program. J Subst Abuse Treat. 2021;122:108200. doi:10.1016/j.jsat.2020.108200
  7. Schneider NM, Steinberg DM, Garcia AM, et al. Pediatric consultation-liaison psychology: insights and lessons learned during the COVID-19 pandemic. J Clin Psychol Med Settings. 2023;30(1):51-60. doi:10.1007/s10880-022-09887-4
  8. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee to Evaluate the Department of Veterans Affairs Mental Health. Mental Health Workforce and Facilities Infrastructure. In: Evaluation of the Department of Veterans Affairs Mental Health Services. National Academies Press (US); 2018. https://www.ncbi.nlm.nih.gov/books/NBK499512/
  9. U.S. Department of Veterans Affairs Veterans Health Administration. Career as a VA social worker. Updated March 3, 2025. Accessed May 6, 2025. https://www.socialwork.va.gov/VA_Employment.asp
  10. United States Senate Committee on Veterans Affairs hearing on “Making the VA the Workplace of Choice for Health Care Providers.” News release. American Psychological Association. April 9, 2008. Accessed April 9, 2025. https:// www.apa.org/news/press/releases/2008/04/testimony
  11. VA National Professional Social Work Month Planning Committee. The diverse, far-reaching VA social worker profession. March 17, 2023. Accessed April 9, 2025. https://news.va.gov/116804/diverse-far-reaching-social-worker-profession/
  12. Patel EL, Bates JM, Holguin JK, et al. Program profile: the expansion of associated health training in the VA. Fed Pract. 2021;38(8):374-380. doi:10.12788/fp.0163
  13. Northcraft H, Bai J, Griffin AR, Hovsepian S, Dobalian A. Association of the COVID-19 pandemic on VA resident and fellow training satisfaction and future VA employment: a mixed methods study. J Grad Med Educ. 2022;14(5):593- 598. doi:10.4300/JGME-D-22-00168.1
  14. Health Resources and Services Administration. Health workforce shortage areas. Accessed April 9, 2025. https://data.hrsa.gov/topics/health-workforce/shortage-areas
  15. Gale RC, Wu J, Erhardt T, et al. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019;14(1):11. doi:10.1186/s13012-019-0853-y
  16. Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018;8(10):e019993. doi:10.1136/bmjopen-2017-019993
  17. Kranke D, Der-Martirosian C, Hovsepian S, et al. Social workers being effective in disaster settings. Soc Work Public Health. 2020;35(8):664-668. doi:10.1080/19371918.20 20.1820928
  18. Kranke D, Gin JL, Der-Martirosian C, Weiss EL, Dobalian A. VA social work leadership and compassion fatigue during the 2017 hurricane season. Soc Work Ment Health. 2020;18:188-199. doi:10.1080/15332985.2019.1700873
  19. Health Resources and Services Administration. Workforce projections. Accessed April 9, 2025. https://data.hrsa.gov/topics/health-workforce/workforce-projections
  20. Der-Martirosian C, Wyte-Lake T, Balut M, et al. Implementation of telehealth services at the US Department of Veterans Affairs during the COVID-19 pandemic: mixed methods study. JMIR Form Res. 2021;5(9):e29429. doi:10.2196/29429
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Impact of Initial Specimen Diversion Technique on Blood Culture Contamination Rates

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Impact of Initial Specimen Diversion Technique on Blood Culture Contamination Rates

Blood cultures provide crucial evidence for diagnostic medicine, specifically aimed at identifying the presence of microbial infections in the bloodstream. Blood culturing is instrumental in diagnosing conditions such as sepsis, bacteremia, or fungemia, where the identification of the causative agent is necessary for targeted and effective treatment.1

The process involves aseptically drawing blood into sterile culture bottles, minimizing the risk of contamination with well-established guidelines. These culture bottles contain specific growth media that support the replication of microorganisms if they are present. Once the blood specimen is collected, it incubates, allowing any potential pathogens to grow. Subsequent analysis and identification of these microorganisms enable health care professionals (HCPs) to prescribe appropriate antimicrobial therapies to treat specific infections, contributing to more effective and targeted patient care.2

The reliability of blood culture results depends on minimizing contamination risk, a challenge inherent in the procedure. Contamination can lead to false-positive results, potentially misguiding treatment.3 HCPs must adhere to strict aseptic techniques during blood draws, ensuring proper skin preparation with antiseptic solutions. The use of sterile equipment and avoiding prolonged tourniquet application helps maintain the integrity of the blood specimen. Timely inoculation of blood into culture bottles and careful handling are essential to mitigate contamination risk.2 Regular training and reinforcement of proper techniques is important to uphold the accuracy of blood culture results and enhance the reliability of diagnoses and treatment decisions.3 Despite diligent contamination prevention efforts, health care systems struggle to maintain contamination rates below the 3.0% national benchmark set by the Clinical & Laboratory Standards Institute (CLSI).4

Blood culture contamination is a critical concern in clinical practice; it can lead to misdiagnosis, prolonged hospital stays, unnecessary antibiotic use, and increased health care costs.5 Monitoring blood culture contamination is integral to patient safety, avoiding inappropriate and potentially harmful treatment, providing efficient care, contributing to antibiotic stewardship, supporting cost efficiency, and maintaining quality assurance and clinical research practices for public health.6

The initial specimen diversion technique (ISDT) recently emerged as a potential strategy to reduce blood culture contamination rates. This technique involves diverting a small portion of the initial blood plus the skin plug from the hollow needle away from the primary collection site before filling the culture bottles. This process minimizes skin surface contaminants, providing a cleaner blood specimen for culturing.7

The ISDT was introduced as a result of historically elevated contamination rates.8 Despite implementing various mitigation methods, the US Department of Veterans Affairs (VA) Central Texas Healthcare System (VACTHCS) has struggled to meet the national benchmark of maintaining blood culture contamination < 3.0%. The VACTHCS is a 146-bed teaching hospital with about 30,000 annual visits at the Olin E. Teague Veterans Affairs Medical Center (OETVMC) emergency department (ED). VACTHCS conducted a 16-month pilot study using 2 commercially available ISDT devices and published the findings.8

The Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2022 (MilCon-VA Act) committee report prioritized the reduction of blood culture contamination to < 1% to prevent health risks and harm to veterans undergoing blood testing for the diagnosis of sepsis.9 Because it had been 5 years since OETVMC began using an ISDT in the ED, the ISDT adaptation strategy for mitigating blood culture contamination was revisited per institution policy.

The objective of this quality improvement project was to analyze retrospective data to understand the long-term impact of ISDT use on blood culture contamination rates. We hypothesized that ISDT use would contribute to efforts to maintain OETVMC ED blood culture contamination rate below the national (3.0%) and VACTHCS (2.5%) thresholds. This project assessed the progress for reducing blood culture contamination compared with the pre-ISDT era.8

METHODS

This retrospective analysis compared the blood culture contamination rates 36 months before and after the introduction of the ISDT device at the OETVMC ED. The preimplementation period was from December 2014 through November 2017 (36 months) and the postimplementation period was December 2017 through November 2020 (36 months). Data were collected from the Department of Pathology and Microbiology blood culture records of all adult patients admitted to the hospital through the ED and required blood cultures for suspicion of infection. Protected health information and VA sensitive information were not collected: all data were deidentified. A total of 18,541 blood cultures were collected 36 months preimplementation and 14,865 blood cultures were collected up to 36 months postimplementation. For comparison purposes, a similar dataset was collected from patients’ blood samples drawn by phlebotomists in the laboratory, where there had been no previous issues with overcontamination; no ISDT devices were used in the collection of these samples.

Blood Culture Contamination Variable

Blood cultures were monitored using the BACT/ALERT 3D (bioMérieux) and subsequently BACT/ALERT VIRTUO (bioMérieux), with positive bottles characterized by VITEK MS Matrix Assisted Laser Desorption Ionization Time-of-Flight technology (bioMérieux) and automated susceptibility testing (VITEK 2 [bioMérieux]).10 In an updated review of blood culture contamination, the American Society for Microbiology used the College of American Pathologists' Q-Probes quality improvement studies as a guideline for classifying contamination. A sample was determined to be contaminated if ≥ 1 of the following organisms were found in only 1 bottle in a series of blood culture sets: coagulase-negative staphylococci, Micrococcus species, α-hemolytic viridans group streptococci, Corynebacterium species, Propionibacterium acnes, and Bacillus species.11 The contamination assessment criteria remained unchanged, except for use of an ISDT device in blood culture collection at the ED.

The VACTHCS Infection Prevention Department ensured that the ISDT device was available and that ED nurses were trained annually on its use to collect blood cultures. Monthly reports of contamination were sent to the nursing supervisor for corrective action and retraining. The initial performance improvement project was slated for 16 months but was expanded to a 6-year period of retrospective data to obtain strong correlation.

Statistical Analysis

Contamination rates were recorded monthly from the hospital laboratory information management system for 36 months both before and after ISDT adoption. Statistical analysis was performed using a 2-tailed unpaired t-test to compare monthly contamination rates for the 2 periods with GraphPad Prism version 10.0.0 for Windows.

RESULTS

Prior to 2017, the ED reported contamination rates above the national (3.0%) and OETVMC thresholds (2.5%), with a mean of 4.5% (95% CI, 3.90-4.90).8 After ISDT implementation, the ED showed significant improvement with a reduction to mean 2.6% (95% CI, 2.10-3.20) (P < .001) (Figure 1). Figure 2 shows monthly blood culture contamination rates at the ED from December 2014 through November 2020. Month 36 (November 2017) shows a clear dip in contamination rate when the ISDT was introduced and month 37 to month 44 show remarkably low contamination rates. During this time, the institute experimented with 2 ISDT devices, and closer scrutiny may reveal this period as an outlier due to the monitoring of ISDT application, as previously reported.8

0625FED-eISDT-F10625FED-eISDT-F2

The blood culture contamination rate for samples drawn by the phlebotomists in the laboratory (excluding the ED) was calculated during the same time period (Figure 3). Non-ED contamination rates remained below 2.5% for 69 of 72 months.

0625FED-eISDT-F3

DISCUSSION

The blood culture contamination rate in the OETVMC ED dropped following ISDT implementation and continued to show long-term benefits. For the 36-month period following ISDT implementation, the mean contamination rate was 2.6%, which was below the national target threshold of 3.0% and close to the OETVMC target of 2.5%. These results suggest that ISDT can have a positive impact on patient care and laboratory efficiency. Improvements in the blood contamination rates in the ED can have a positive impact on the overall hospital contamination rates.

Blood drawn by phlebotomists in the hospital laboratory infrequently had contamination rates that exceeded the 2.5% target threshold. Because the non-ED contamination rates did not change throughout the comparison period, other factors were likely not involved in the improvements seen in the ED. The decision to implement ISDT exclusively in the ED was based on its historically elevated contamination rate.8 Issues with blood culture contamination in EDs across various hospital systems are well documented and not unique to VACTHCS.12

Contamination in blood cultures can be a significant issue in the hospital. It occurs when microorganisms from the skin or environment enter the blood culture sample during collection. Moreover, it can contribute to antibiotic resistance when patients are prescribed inappropriate antibiotics. It is also important to ensure HCPs are well-trained and consistently follow standardized protocols and understand the implications of false-positive results.13

ISDT helps reduce false-positive results and is a significant advancement in the field of blood culture collection.8,14 By discarding the initial blood, it ensures that only the true bloodstream sample is cultured, leading to more accurate results.15 It also may minimize the risk of contamination-related delays in diagnosis and treatment and benefits patients and health care institutions by potentially reducing hospital stays, unnecessary antibiotic use, and health care costs.

One of the ISDT device manufacturers estimated the financial impact on OETVMC based on the pilot project.8 While this study did not calculate the direct and indirect cost savings associated with this process improvement, the manufacturer’s website suggests that VACTHCS could annually save about $486,000.16 Furthermore, implementation of ISDT may improve laboratory efficiency, as they reduce the workload associated with identifying and reporting false-positive cultures. 6 ISDT devices represent a valuable tool in the efforts to reduce blood culture contamination and its wide-ranging implications in clinical settings. While ISDT alone will not be sufficient in achieving a lower threshold (< 1%) of blood culture contamination, it can be part of a multiprong effort that optimizes best practices in the collection, handling, and management of blood cultures.

Continuous quality improvement efforts and monitoring of blood culture contamination rates can help health care institutions identify problem areas and implement necessary changes. Addressing blood culture contamination can improve patient care, reduce costs, and address antibiotic resistance.

Limitations

This study was limited by its study design, which did not use a side-by-side comparison of blood cultures from groups with and without ISDT. All blood cultures from patients in the region were processed at OETVMC, which may not be representative of non-VA EDs. Part of this study took place during the COVID-19 pandemic, which may have skewed data. Additionally, hospital data were collected from a veteran population in Central Texas, and the lack of demographic diversity may not be generalizable to the greater population.

CONCLUSIONS

The findings of this study suggest ISDT may be effective in reducing blood culture contamination rates in the high-risk ED environment, which aligns with previous research. 5,14 The ISDT may help reduce blood culture contamination rates, improving the quality of patient care and reducing health care costs. MilCon-VA mandated that all VA facilities have blood culture contamination as a metric with a goal of blood culture contamination rates < 1%.8 However, achieving this goal remains a challenge. Further research and continuous quality improvement efforts are necessary to achieve it. Consistently achieving a contamination threshold of < 1% may require minimizing human error. An automated robotic venipuncture device, as recently designed and reported, may be necessary to reduce human error in blood draw and contamination.16

References
  1. Chela HK, Vasudevan A, Rojas-Moreno C, Naqvi SH. Approach to positive blood cultures in the hospitalized patient: a review. Mo Med. 2019;116(4):313-317.
  2. Lamy B, Dargère S, Arendrup MC, Parienti JJ, Tattevin P. How to optimize the use of blood cultures for the diagnosis of bloodstream infections? A state-of-the art. Front Microbiol. 2016;7:697. doi:10.3389/fmicb.2016.00697
  3. Doern GV, Carroll KC, Diekema DJ, et al. Practical guidance for clinical microbiology laboratories: a comprehensive update on the problem of blood culture contamination and a discussion of methods for addressing the problem. Clin Microbiol Rev. 2019;33:e00009-19. doi:10.1128/CMR.00009-19
  4. Wilson ML, Kirn Jr TJ, Antonara S, et al. Clinical and Laboratory Standards Institute Guideline M47—Principles and Procedures for Blood Cultures. Clinical and Laboratory Standards Institute. April 22, 2022. Accessed May 21, 2025. https://clsi.org/shop/standards/m47/
  5. Hancock JA, Campbell S, Jones MM, Wang-Rodriguez J, VHA Microbiology SME Workgroup, Klutts JS. Development and validation of a standardized blood culture contamination definition and metric dashboard for a large health care system. Am J Clin Pathol. 2023;160(3):255-260. doi:10.1093/ajcp/aqad044
  6. Shinozaki T, Deane RS, Mazuzan JE Jr, Hamel AJ, Hazelton D. Bacterial contamination of arterial lines. A prospective study. JAMA. 1983;249(2):223-225.
  7. Al Mohajer M, Lasco T. The impact of initial specimen diversion systems on blood culture contamination. Open Forum Infect Dis. 2023;10:ofad182. doi:10.1093/ofid/ofad182
  8. Arenas M, Boseman GM, Coppin JD, Lukey J, Jinadatha C, Navarathna DH. Asynchronous testing of 2 specimen-diversion devices to reduce blood culture contamination: a single-site product supply quality improvement project. J Emerg Nurs. 2021;47(2):256-264. e6. doi:10.1016/j.jen.2020.11.008
  9. Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2022, HR 4355, 117th Cong (2021-2022). Accessed May 12, 2025. https://www.congress.gov/bill/117th-congress/house-bill/4355?
  10. Altun O, Almuhayawi M, Lüthje P, Taha R, Ullberg M, Özenci V. Controlled evaluation of the New BacT/ Alert Virtuo blood culture system for detection and time to detection of bacteria and yeasts. J Clin Microbiol. 2016;54(4):1148-1151. doi:10.1128/JCM.03362-15
  11. Hall KK, Lyman JA. Updated review of blood culture contamination. Clin Microbiol Rev. 2006;19(4):788-802. doi:10.1128/CMR.00062-05
  12. Gander RM, Byrd L, DeCrescenzo M, Hirany S, Bowen M, Baughman J. Impact of blood cultures drawn by phlebotomy on contamination rates and health care costs in a hospital emergency department. J Clin Microbiol. 2009;47(4):1021-1024. doi:10.1128/JCM.02162-08
  13. Garcia RA, Spitzer ED, Beaudry J, et al. Multidisciplinary team review of best practices for collection and handling of blood cultures to determine effective interventions for increasing the yield of true-positive bacteremias, reducing contamination, and eliminating false-positive central lineassociated bloodstream infections. Am J Infect Control. 2015;43(11):1222-1237. doi:10.1016/j.ajic.2015.06.030
  14. Callado GY, Lin V, Thottacherry E, et al. Diagnostic stewardship: a systematic review and meta-analysis of blood collection diversion devices used to reduce blood culture contamination and improve the accuracy of diagnosis in clinical settings. Open Forum Infect Dis. 2023;10(9):ofad433. doi:10.1093/ofid/ofad433
  15. Patton RG, Schmitt T. Innovation for reducing blood culture contamination: initial specimen diversion technique. J Clin Microbiol. 2010;48:4501-4503. doi:10.1128/JCM.00910-10
  16. Kurin. Clinical evidence: published Kurin studies. 2024. Accessed May 12, 2025. https://www.kurin.com/studies
  17. Leipheimer JM, Balter ML, Chen AI, et al. First-in-human evaluation of a hand-held automated venipuncture device for rapid venous blood draws. Technology (Singap World Sci). 2019;7(3-4):98-107. doi:10.1142/S2339547819500067?
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Correspondence: Dhammika Navarathna (dhammika.navarathna@ va.gov)

Fed Pract. 2025;42(6):e0596. Published online June 17. doi:10.12788/fp.0596

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Fed Pract. 2025;42(6):e0596. Published online June 17. doi:10.12788/fp.0596

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Correspondence: Dhammika Navarathna (dhammika.navarathna@ va.gov)

Fed Pract. 2025;42(6):e0596. Published online June 17. doi:10.12788/fp.0596

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Blood cultures provide crucial evidence for diagnostic medicine, specifically aimed at identifying the presence of microbial infections in the bloodstream. Blood culturing is instrumental in diagnosing conditions such as sepsis, bacteremia, or fungemia, where the identification of the causative agent is necessary for targeted and effective treatment.1

The process involves aseptically drawing blood into sterile culture bottles, minimizing the risk of contamination with well-established guidelines. These culture bottles contain specific growth media that support the replication of microorganisms if they are present. Once the blood specimen is collected, it incubates, allowing any potential pathogens to grow. Subsequent analysis and identification of these microorganisms enable health care professionals (HCPs) to prescribe appropriate antimicrobial therapies to treat specific infections, contributing to more effective and targeted patient care.2

The reliability of blood culture results depends on minimizing contamination risk, a challenge inherent in the procedure. Contamination can lead to false-positive results, potentially misguiding treatment.3 HCPs must adhere to strict aseptic techniques during blood draws, ensuring proper skin preparation with antiseptic solutions. The use of sterile equipment and avoiding prolonged tourniquet application helps maintain the integrity of the blood specimen. Timely inoculation of blood into culture bottles and careful handling are essential to mitigate contamination risk.2 Regular training and reinforcement of proper techniques is important to uphold the accuracy of blood culture results and enhance the reliability of diagnoses and treatment decisions.3 Despite diligent contamination prevention efforts, health care systems struggle to maintain contamination rates below the 3.0% national benchmark set by the Clinical & Laboratory Standards Institute (CLSI).4

Blood culture contamination is a critical concern in clinical practice; it can lead to misdiagnosis, prolonged hospital stays, unnecessary antibiotic use, and increased health care costs.5 Monitoring blood culture contamination is integral to patient safety, avoiding inappropriate and potentially harmful treatment, providing efficient care, contributing to antibiotic stewardship, supporting cost efficiency, and maintaining quality assurance and clinical research practices for public health.6

The initial specimen diversion technique (ISDT) recently emerged as a potential strategy to reduce blood culture contamination rates. This technique involves diverting a small portion of the initial blood plus the skin plug from the hollow needle away from the primary collection site before filling the culture bottles. This process minimizes skin surface contaminants, providing a cleaner blood specimen for culturing.7

The ISDT was introduced as a result of historically elevated contamination rates.8 Despite implementing various mitigation methods, the US Department of Veterans Affairs (VA) Central Texas Healthcare System (VACTHCS) has struggled to meet the national benchmark of maintaining blood culture contamination < 3.0%. The VACTHCS is a 146-bed teaching hospital with about 30,000 annual visits at the Olin E. Teague Veterans Affairs Medical Center (OETVMC) emergency department (ED). VACTHCS conducted a 16-month pilot study using 2 commercially available ISDT devices and published the findings.8

The Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2022 (MilCon-VA Act) committee report prioritized the reduction of blood culture contamination to < 1% to prevent health risks and harm to veterans undergoing blood testing for the diagnosis of sepsis.9 Because it had been 5 years since OETVMC began using an ISDT in the ED, the ISDT adaptation strategy for mitigating blood culture contamination was revisited per institution policy.

The objective of this quality improvement project was to analyze retrospective data to understand the long-term impact of ISDT use on blood culture contamination rates. We hypothesized that ISDT use would contribute to efforts to maintain OETVMC ED blood culture contamination rate below the national (3.0%) and VACTHCS (2.5%) thresholds. This project assessed the progress for reducing blood culture contamination compared with the pre-ISDT era.8

METHODS

This retrospective analysis compared the blood culture contamination rates 36 months before and after the introduction of the ISDT device at the OETVMC ED. The preimplementation period was from December 2014 through November 2017 (36 months) and the postimplementation period was December 2017 through November 2020 (36 months). Data were collected from the Department of Pathology and Microbiology blood culture records of all adult patients admitted to the hospital through the ED and required blood cultures for suspicion of infection. Protected health information and VA sensitive information were not collected: all data were deidentified. A total of 18,541 blood cultures were collected 36 months preimplementation and 14,865 blood cultures were collected up to 36 months postimplementation. For comparison purposes, a similar dataset was collected from patients’ blood samples drawn by phlebotomists in the laboratory, where there had been no previous issues with overcontamination; no ISDT devices were used in the collection of these samples.

Blood Culture Contamination Variable

Blood cultures were monitored using the BACT/ALERT 3D (bioMérieux) and subsequently BACT/ALERT VIRTUO (bioMérieux), with positive bottles characterized by VITEK MS Matrix Assisted Laser Desorption Ionization Time-of-Flight technology (bioMérieux) and automated susceptibility testing (VITEK 2 [bioMérieux]).10 In an updated review of blood culture contamination, the American Society for Microbiology used the College of American Pathologists' Q-Probes quality improvement studies as a guideline for classifying contamination. A sample was determined to be contaminated if ≥ 1 of the following organisms were found in only 1 bottle in a series of blood culture sets: coagulase-negative staphylococci, Micrococcus species, α-hemolytic viridans group streptococci, Corynebacterium species, Propionibacterium acnes, and Bacillus species.11 The contamination assessment criteria remained unchanged, except for use of an ISDT device in blood culture collection at the ED.

The VACTHCS Infection Prevention Department ensured that the ISDT device was available and that ED nurses were trained annually on its use to collect blood cultures. Monthly reports of contamination were sent to the nursing supervisor for corrective action and retraining. The initial performance improvement project was slated for 16 months but was expanded to a 6-year period of retrospective data to obtain strong correlation.

Statistical Analysis

Contamination rates were recorded monthly from the hospital laboratory information management system for 36 months both before and after ISDT adoption. Statistical analysis was performed using a 2-tailed unpaired t-test to compare monthly contamination rates for the 2 periods with GraphPad Prism version 10.0.0 for Windows.

RESULTS

Prior to 2017, the ED reported contamination rates above the national (3.0%) and OETVMC thresholds (2.5%), with a mean of 4.5% (95% CI, 3.90-4.90).8 After ISDT implementation, the ED showed significant improvement with a reduction to mean 2.6% (95% CI, 2.10-3.20) (P < .001) (Figure 1). Figure 2 shows monthly blood culture contamination rates at the ED from December 2014 through November 2020. Month 36 (November 2017) shows a clear dip in contamination rate when the ISDT was introduced and month 37 to month 44 show remarkably low contamination rates. During this time, the institute experimented with 2 ISDT devices, and closer scrutiny may reveal this period as an outlier due to the monitoring of ISDT application, as previously reported.8

0625FED-eISDT-F10625FED-eISDT-F2

The blood culture contamination rate for samples drawn by the phlebotomists in the laboratory (excluding the ED) was calculated during the same time period (Figure 3). Non-ED contamination rates remained below 2.5% for 69 of 72 months.

0625FED-eISDT-F3

DISCUSSION

The blood culture contamination rate in the OETVMC ED dropped following ISDT implementation and continued to show long-term benefits. For the 36-month period following ISDT implementation, the mean contamination rate was 2.6%, which was below the national target threshold of 3.0% and close to the OETVMC target of 2.5%. These results suggest that ISDT can have a positive impact on patient care and laboratory efficiency. Improvements in the blood contamination rates in the ED can have a positive impact on the overall hospital contamination rates.

Blood drawn by phlebotomists in the hospital laboratory infrequently had contamination rates that exceeded the 2.5% target threshold. Because the non-ED contamination rates did not change throughout the comparison period, other factors were likely not involved in the improvements seen in the ED. The decision to implement ISDT exclusively in the ED was based on its historically elevated contamination rate.8 Issues with blood culture contamination in EDs across various hospital systems are well documented and not unique to VACTHCS.12

Contamination in blood cultures can be a significant issue in the hospital. It occurs when microorganisms from the skin or environment enter the blood culture sample during collection. Moreover, it can contribute to antibiotic resistance when patients are prescribed inappropriate antibiotics. It is also important to ensure HCPs are well-trained and consistently follow standardized protocols and understand the implications of false-positive results.13

ISDT helps reduce false-positive results and is a significant advancement in the field of blood culture collection.8,14 By discarding the initial blood, it ensures that only the true bloodstream sample is cultured, leading to more accurate results.15 It also may minimize the risk of contamination-related delays in diagnosis and treatment and benefits patients and health care institutions by potentially reducing hospital stays, unnecessary antibiotic use, and health care costs.

One of the ISDT device manufacturers estimated the financial impact on OETVMC based on the pilot project.8 While this study did not calculate the direct and indirect cost savings associated with this process improvement, the manufacturer’s website suggests that VACTHCS could annually save about $486,000.16 Furthermore, implementation of ISDT may improve laboratory efficiency, as they reduce the workload associated with identifying and reporting false-positive cultures. 6 ISDT devices represent a valuable tool in the efforts to reduce blood culture contamination and its wide-ranging implications in clinical settings. While ISDT alone will not be sufficient in achieving a lower threshold (< 1%) of blood culture contamination, it can be part of a multiprong effort that optimizes best practices in the collection, handling, and management of blood cultures.

Continuous quality improvement efforts and monitoring of blood culture contamination rates can help health care institutions identify problem areas and implement necessary changes. Addressing blood culture contamination can improve patient care, reduce costs, and address antibiotic resistance.

Limitations

This study was limited by its study design, which did not use a side-by-side comparison of blood cultures from groups with and without ISDT. All blood cultures from patients in the region were processed at OETVMC, which may not be representative of non-VA EDs. Part of this study took place during the COVID-19 pandemic, which may have skewed data. Additionally, hospital data were collected from a veteran population in Central Texas, and the lack of demographic diversity may not be generalizable to the greater population.

CONCLUSIONS

The findings of this study suggest ISDT may be effective in reducing blood culture contamination rates in the high-risk ED environment, which aligns with previous research. 5,14 The ISDT may help reduce blood culture contamination rates, improving the quality of patient care and reducing health care costs. MilCon-VA mandated that all VA facilities have blood culture contamination as a metric with a goal of blood culture contamination rates < 1%.8 However, achieving this goal remains a challenge. Further research and continuous quality improvement efforts are necessary to achieve it. Consistently achieving a contamination threshold of < 1% may require minimizing human error. An automated robotic venipuncture device, as recently designed and reported, may be necessary to reduce human error in blood draw and contamination.16

Blood cultures provide crucial evidence for diagnostic medicine, specifically aimed at identifying the presence of microbial infections in the bloodstream. Blood culturing is instrumental in diagnosing conditions such as sepsis, bacteremia, or fungemia, where the identification of the causative agent is necessary for targeted and effective treatment.1

The process involves aseptically drawing blood into sterile culture bottles, minimizing the risk of contamination with well-established guidelines. These culture bottles contain specific growth media that support the replication of microorganisms if they are present. Once the blood specimen is collected, it incubates, allowing any potential pathogens to grow. Subsequent analysis and identification of these microorganisms enable health care professionals (HCPs) to prescribe appropriate antimicrobial therapies to treat specific infections, contributing to more effective and targeted patient care.2

The reliability of blood culture results depends on minimizing contamination risk, a challenge inherent in the procedure. Contamination can lead to false-positive results, potentially misguiding treatment.3 HCPs must adhere to strict aseptic techniques during blood draws, ensuring proper skin preparation with antiseptic solutions. The use of sterile equipment and avoiding prolonged tourniquet application helps maintain the integrity of the blood specimen. Timely inoculation of blood into culture bottles and careful handling are essential to mitigate contamination risk.2 Regular training and reinforcement of proper techniques is important to uphold the accuracy of blood culture results and enhance the reliability of diagnoses and treatment decisions.3 Despite diligent contamination prevention efforts, health care systems struggle to maintain contamination rates below the 3.0% national benchmark set by the Clinical & Laboratory Standards Institute (CLSI).4

Blood culture contamination is a critical concern in clinical practice; it can lead to misdiagnosis, prolonged hospital stays, unnecessary antibiotic use, and increased health care costs.5 Monitoring blood culture contamination is integral to patient safety, avoiding inappropriate and potentially harmful treatment, providing efficient care, contributing to antibiotic stewardship, supporting cost efficiency, and maintaining quality assurance and clinical research practices for public health.6

The initial specimen diversion technique (ISDT) recently emerged as a potential strategy to reduce blood culture contamination rates. This technique involves diverting a small portion of the initial blood plus the skin plug from the hollow needle away from the primary collection site before filling the culture bottles. This process minimizes skin surface contaminants, providing a cleaner blood specimen for culturing.7

The ISDT was introduced as a result of historically elevated contamination rates.8 Despite implementing various mitigation methods, the US Department of Veterans Affairs (VA) Central Texas Healthcare System (VACTHCS) has struggled to meet the national benchmark of maintaining blood culture contamination < 3.0%. The VACTHCS is a 146-bed teaching hospital with about 30,000 annual visits at the Olin E. Teague Veterans Affairs Medical Center (OETVMC) emergency department (ED). VACTHCS conducted a 16-month pilot study using 2 commercially available ISDT devices and published the findings.8

The Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2022 (MilCon-VA Act) committee report prioritized the reduction of blood culture contamination to < 1% to prevent health risks and harm to veterans undergoing blood testing for the diagnosis of sepsis.9 Because it had been 5 years since OETVMC began using an ISDT in the ED, the ISDT adaptation strategy for mitigating blood culture contamination was revisited per institution policy.

The objective of this quality improvement project was to analyze retrospective data to understand the long-term impact of ISDT use on blood culture contamination rates. We hypothesized that ISDT use would contribute to efforts to maintain OETVMC ED blood culture contamination rate below the national (3.0%) and VACTHCS (2.5%) thresholds. This project assessed the progress for reducing blood culture contamination compared with the pre-ISDT era.8

METHODS

This retrospective analysis compared the blood culture contamination rates 36 months before and after the introduction of the ISDT device at the OETVMC ED. The preimplementation period was from December 2014 through November 2017 (36 months) and the postimplementation period was December 2017 through November 2020 (36 months). Data were collected from the Department of Pathology and Microbiology blood culture records of all adult patients admitted to the hospital through the ED and required blood cultures for suspicion of infection. Protected health information and VA sensitive information were not collected: all data were deidentified. A total of 18,541 blood cultures were collected 36 months preimplementation and 14,865 blood cultures were collected up to 36 months postimplementation. For comparison purposes, a similar dataset was collected from patients’ blood samples drawn by phlebotomists in the laboratory, where there had been no previous issues with overcontamination; no ISDT devices were used in the collection of these samples.

Blood Culture Contamination Variable

Blood cultures were monitored using the BACT/ALERT 3D (bioMérieux) and subsequently BACT/ALERT VIRTUO (bioMérieux), with positive bottles characterized by VITEK MS Matrix Assisted Laser Desorption Ionization Time-of-Flight technology (bioMérieux) and automated susceptibility testing (VITEK 2 [bioMérieux]).10 In an updated review of blood culture contamination, the American Society for Microbiology used the College of American Pathologists' Q-Probes quality improvement studies as a guideline for classifying contamination. A sample was determined to be contaminated if ≥ 1 of the following organisms were found in only 1 bottle in a series of blood culture sets: coagulase-negative staphylococci, Micrococcus species, α-hemolytic viridans group streptococci, Corynebacterium species, Propionibacterium acnes, and Bacillus species.11 The contamination assessment criteria remained unchanged, except for use of an ISDT device in blood culture collection at the ED.

The VACTHCS Infection Prevention Department ensured that the ISDT device was available and that ED nurses were trained annually on its use to collect blood cultures. Monthly reports of contamination were sent to the nursing supervisor for corrective action and retraining. The initial performance improvement project was slated for 16 months but was expanded to a 6-year period of retrospective data to obtain strong correlation.

Statistical Analysis

Contamination rates were recorded monthly from the hospital laboratory information management system for 36 months both before and after ISDT adoption. Statistical analysis was performed using a 2-tailed unpaired t-test to compare monthly contamination rates for the 2 periods with GraphPad Prism version 10.0.0 for Windows.

RESULTS

Prior to 2017, the ED reported contamination rates above the national (3.0%) and OETVMC thresholds (2.5%), with a mean of 4.5% (95% CI, 3.90-4.90).8 After ISDT implementation, the ED showed significant improvement with a reduction to mean 2.6% (95% CI, 2.10-3.20) (P < .001) (Figure 1). Figure 2 shows monthly blood culture contamination rates at the ED from December 2014 through November 2020. Month 36 (November 2017) shows a clear dip in contamination rate when the ISDT was introduced and month 37 to month 44 show remarkably low contamination rates. During this time, the institute experimented with 2 ISDT devices, and closer scrutiny may reveal this period as an outlier due to the monitoring of ISDT application, as previously reported.8

0625FED-eISDT-F10625FED-eISDT-F2

The blood culture contamination rate for samples drawn by the phlebotomists in the laboratory (excluding the ED) was calculated during the same time period (Figure 3). Non-ED contamination rates remained below 2.5% for 69 of 72 months.

0625FED-eISDT-F3

DISCUSSION

The blood culture contamination rate in the OETVMC ED dropped following ISDT implementation and continued to show long-term benefits. For the 36-month period following ISDT implementation, the mean contamination rate was 2.6%, which was below the national target threshold of 3.0% and close to the OETVMC target of 2.5%. These results suggest that ISDT can have a positive impact on patient care and laboratory efficiency. Improvements in the blood contamination rates in the ED can have a positive impact on the overall hospital contamination rates.

Blood drawn by phlebotomists in the hospital laboratory infrequently had contamination rates that exceeded the 2.5% target threshold. Because the non-ED contamination rates did not change throughout the comparison period, other factors were likely not involved in the improvements seen in the ED. The decision to implement ISDT exclusively in the ED was based on its historically elevated contamination rate.8 Issues with blood culture contamination in EDs across various hospital systems are well documented and not unique to VACTHCS.12

Contamination in blood cultures can be a significant issue in the hospital. It occurs when microorganisms from the skin or environment enter the blood culture sample during collection. Moreover, it can contribute to antibiotic resistance when patients are prescribed inappropriate antibiotics. It is also important to ensure HCPs are well-trained and consistently follow standardized protocols and understand the implications of false-positive results.13

ISDT helps reduce false-positive results and is a significant advancement in the field of blood culture collection.8,14 By discarding the initial blood, it ensures that only the true bloodstream sample is cultured, leading to more accurate results.15 It also may minimize the risk of contamination-related delays in diagnosis and treatment and benefits patients and health care institutions by potentially reducing hospital stays, unnecessary antibiotic use, and health care costs.

One of the ISDT device manufacturers estimated the financial impact on OETVMC based on the pilot project.8 While this study did not calculate the direct and indirect cost savings associated with this process improvement, the manufacturer’s website suggests that VACTHCS could annually save about $486,000.16 Furthermore, implementation of ISDT may improve laboratory efficiency, as they reduce the workload associated with identifying and reporting false-positive cultures. 6 ISDT devices represent a valuable tool in the efforts to reduce blood culture contamination and its wide-ranging implications in clinical settings. While ISDT alone will not be sufficient in achieving a lower threshold (< 1%) of blood culture contamination, it can be part of a multiprong effort that optimizes best practices in the collection, handling, and management of blood cultures.

Continuous quality improvement efforts and monitoring of blood culture contamination rates can help health care institutions identify problem areas and implement necessary changes. Addressing blood culture contamination can improve patient care, reduce costs, and address antibiotic resistance.

Limitations

This study was limited by its study design, which did not use a side-by-side comparison of blood cultures from groups with and without ISDT. All blood cultures from patients in the region were processed at OETVMC, which may not be representative of non-VA EDs. Part of this study took place during the COVID-19 pandemic, which may have skewed data. Additionally, hospital data were collected from a veteran population in Central Texas, and the lack of demographic diversity may not be generalizable to the greater population.

CONCLUSIONS

The findings of this study suggest ISDT may be effective in reducing blood culture contamination rates in the high-risk ED environment, which aligns with previous research. 5,14 The ISDT may help reduce blood culture contamination rates, improving the quality of patient care and reducing health care costs. MilCon-VA mandated that all VA facilities have blood culture contamination as a metric with a goal of blood culture contamination rates < 1%.8 However, achieving this goal remains a challenge. Further research and continuous quality improvement efforts are necessary to achieve it. Consistently achieving a contamination threshold of < 1% may require minimizing human error. An automated robotic venipuncture device, as recently designed and reported, may be necessary to reduce human error in blood draw and contamination.16

References
  1. Chela HK, Vasudevan A, Rojas-Moreno C, Naqvi SH. Approach to positive blood cultures in the hospitalized patient: a review. Mo Med. 2019;116(4):313-317.
  2. Lamy B, Dargère S, Arendrup MC, Parienti JJ, Tattevin P. How to optimize the use of blood cultures for the diagnosis of bloodstream infections? A state-of-the art. Front Microbiol. 2016;7:697. doi:10.3389/fmicb.2016.00697
  3. Doern GV, Carroll KC, Diekema DJ, et al. Practical guidance for clinical microbiology laboratories: a comprehensive update on the problem of blood culture contamination and a discussion of methods for addressing the problem. Clin Microbiol Rev. 2019;33:e00009-19. doi:10.1128/CMR.00009-19
  4. Wilson ML, Kirn Jr TJ, Antonara S, et al. Clinical and Laboratory Standards Institute Guideline M47—Principles and Procedures for Blood Cultures. Clinical and Laboratory Standards Institute. April 22, 2022. Accessed May 21, 2025. https://clsi.org/shop/standards/m47/
  5. Hancock JA, Campbell S, Jones MM, Wang-Rodriguez J, VHA Microbiology SME Workgroup, Klutts JS. Development and validation of a standardized blood culture contamination definition and metric dashboard for a large health care system. Am J Clin Pathol. 2023;160(3):255-260. doi:10.1093/ajcp/aqad044
  6. Shinozaki T, Deane RS, Mazuzan JE Jr, Hamel AJ, Hazelton D. Bacterial contamination of arterial lines. A prospective study. JAMA. 1983;249(2):223-225.
  7. Al Mohajer M, Lasco T. The impact of initial specimen diversion systems on blood culture contamination. Open Forum Infect Dis. 2023;10:ofad182. doi:10.1093/ofid/ofad182
  8. Arenas M, Boseman GM, Coppin JD, Lukey J, Jinadatha C, Navarathna DH. Asynchronous testing of 2 specimen-diversion devices to reduce blood culture contamination: a single-site product supply quality improvement project. J Emerg Nurs. 2021;47(2):256-264. e6. doi:10.1016/j.jen.2020.11.008
  9. Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2022, HR 4355, 117th Cong (2021-2022). Accessed May 12, 2025. https://www.congress.gov/bill/117th-congress/house-bill/4355?
  10. Altun O, Almuhayawi M, Lüthje P, Taha R, Ullberg M, Özenci V. Controlled evaluation of the New BacT/ Alert Virtuo blood culture system for detection and time to detection of bacteria and yeasts. J Clin Microbiol. 2016;54(4):1148-1151. doi:10.1128/JCM.03362-15
  11. Hall KK, Lyman JA. Updated review of blood culture contamination. Clin Microbiol Rev. 2006;19(4):788-802. doi:10.1128/CMR.00062-05
  12. Gander RM, Byrd L, DeCrescenzo M, Hirany S, Bowen M, Baughman J. Impact of blood cultures drawn by phlebotomy on contamination rates and health care costs in a hospital emergency department. J Clin Microbiol. 2009;47(4):1021-1024. doi:10.1128/JCM.02162-08
  13. Garcia RA, Spitzer ED, Beaudry J, et al. Multidisciplinary team review of best practices for collection and handling of blood cultures to determine effective interventions for increasing the yield of true-positive bacteremias, reducing contamination, and eliminating false-positive central lineassociated bloodstream infections. Am J Infect Control. 2015;43(11):1222-1237. doi:10.1016/j.ajic.2015.06.030
  14. Callado GY, Lin V, Thottacherry E, et al. Diagnostic stewardship: a systematic review and meta-analysis of blood collection diversion devices used to reduce blood culture contamination and improve the accuracy of diagnosis in clinical settings. Open Forum Infect Dis. 2023;10(9):ofad433. doi:10.1093/ofid/ofad433
  15. Patton RG, Schmitt T. Innovation for reducing blood culture contamination: initial specimen diversion technique. J Clin Microbiol. 2010;48:4501-4503. doi:10.1128/JCM.00910-10
  16. Kurin. Clinical evidence: published Kurin studies. 2024. Accessed May 12, 2025. https://www.kurin.com/studies
  17. Leipheimer JM, Balter ML, Chen AI, et al. First-in-human evaluation of a hand-held automated venipuncture device for rapid venous blood draws. Technology (Singap World Sci). 2019;7(3-4):98-107. doi:10.1142/S2339547819500067?
References
  1. Chela HK, Vasudevan A, Rojas-Moreno C, Naqvi SH. Approach to positive blood cultures in the hospitalized patient: a review. Mo Med. 2019;116(4):313-317.
  2. Lamy B, Dargère S, Arendrup MC, Parienti JJ, Tattevin P. How to optimize the use of blood cultures for the diagnosis of bloodstream infections? A state-of-the art. Front Microbiol. 2016;7:697. doi:10.3389/fmicb.2016.00697
  3. Doern GV, Carroll KC, Diekema DJ, et al. Practical guidance for clinical microbiology laboratories: a comprehensive update on the problem of blood culture contamination and a discussion of methods for addressing the problem. Clin Microbiol Rev. 2019;33:e00009-19. doi:10.1128/CMR.00009-19
  4. Wilson ML, Kirn Jr TJ, Antonara S, et al. Clinical and Laboratory Standards Institute Guideline M47—Principles and Procedures for Blood Cultures. Clinical and Laboratory Standards Institute. April 22, 2022. Accessed May 21, 2025. https://clsi.org/shop/standards/m47/
  5. Hancock JA, Campbell S, Jones MM, Wang-Rodriguez J, VHA Microbiology SME Workgroup, Klutts JS. Development and validation of a standardized blood culture contamination definition and metric dashboard for a large health care system. Am J Clin Pathol. 2023;160(3):255-260. doi:10.1093/ajcp/aqad044
  6. Shinozaki T, Deane RS, Mazuzan JE Jr, Hamel AJ, Hazelton D. Bacterial contamination of arterial lines. A prospective study. JAMA. 1983;249(2):223-225.
  7. Al Mohajer M, Lasco T. The impact of initial specimen diversion systems on blood culture contamination. Open Forum Infect Dis. 2023;10:ofad182. doi:10.1093/ofid/ofad182
  8. Arenas M, Boseman GM, Coppin JD, Lukey J, Jinadatha C, Navarathna DH. Asynchronous testing of 2 specimen-diversion devices to reduce blood culture contamination: a single-site product supply quality improvement project. J Emerg Nurs. 2021;47(2):256-264. e6. doi:10.1016/j.jen.2020.11.008
  9. Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2022, HR 4355, 117th Cong (2021-2022). Accessed May 12, 2025. https://www.congress.gov/bill/117th-congress/house-bill/4355?
  10. Altun O, Almuhayawi M, Lüthje P, Taha R, Ullberg M, Özenci V. Controlled evaluation of the New BacT/ Alert Virtuo blood culture system for detection and time to detection of bacteria and yeasts. J Clin Microbiol. 2016;54(4):1148-1151. doi:10.1128/JCM.03362-15
  11. Hall KK, Lyman JA. Updated review of blood culture contamination. Clin Microbiol Rev. 2006;19(4):788-802. doi:10.1128/CMR.00062-05
  12. Gander RM, Byrd L, DeCrescenzo M, Hirany S, Bowen M, Baughman J. Impact of blood cultures drawn by phlebotomy on contamination rates and health care costs in a hospital emergency department. J Clin Microbiol. 2009;47(4):1021-1024. doi:10.1128/JCM.02162-08
  13. Garcia RA, Spitzer ED, Beaudry J, et al. Multidisciplinary team review of best practices for collection and handling of blood cultures to determine effective interventions for increasing the yield of true-positive bacteremias, reducing contamination, and eliminating false-positive central lineassociated bloodstream infections. Am J Infect Control. 2015;43(11):1222-1237. doi:10.1016/j.ajic.2015.06.030
  14. Callado GY, Lin V, Thottacherry E, et al. Diagnostic stewardship: a systematic review and meta-analysis of blood collection diversion devices used to reduce blood culture contamination and improve the accuracy of diagnosis in clinical settings. Open Forum Infect Dis. 2023;10(9):ofad433. doi:10.1093/ofid/ofad433
  15. Patton RG, Schmitt T. Innovation for reducing blood culture contamination: initial specimen diversion technique. J Clin Microbiol. 2010;48:4501-4503. doi:10.1128/JCM.00910-10
  16. Kurin. Clinical evidence: published Kurin studies. 2024. Accessed May 12, 2025. https://www.kurin.com/studies
  17. Leipheimer JM, Balter ML, Chen AI, et al. First-in-human evaluation of a hand-held automated venipuncture device for rapid venous blood draws. Technology (Singap World Sci). 2019;7(3-4):98-107. doi:10.1142/S2339547819500067?
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Comparing the Quality of Patient Guidance on Dermatologic Care Generated by ChatGPT vs Reddit

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Comparing the Quality of Patient Guidance on Dermatologic Care Generated by ChatGPT vs Reddit

To the Editor:

Online resources that are convenient and affordable play a crucial role in mitigating health inequality and improving patient access to health care information; however, the benefits are limited by the quality of information available, as medical misinformation can lead to patients engaging in harmful practices, making dangerous decisions, and even avoiding safe and effective treatments. In this study, we aimed to assess and compare the quality of patient guidance on dermatologic care generated by ChatGPT vs Reddit based on accuracy, appropriateness, and safety. It is essential to assess the quality and reliability of online health information to support patients in making informed decisions about their health.

The emergence and advancement of artificial intelligence and large language models such as ChatGPT present a new method for patients to access health care advice. ChatGPT can engage in conversation by accessing information from existing publicly available data on the internet, including books and websites, up to the year 2023 and providing humanlike responses with context.1 ChatGPT’s access to a breadth of online evidence-based literature ensures the dissemination of quality information that is quick and without inherent bias, offering the potential to more closely align with health care professionals. ChatGPT’s use in dermatology by patients has shown efficacy, with a 98.87% approval rate by dermatologists scoring its ability to recommend appropriate medication for common dermatologic conditions.2 However, ChatGPT has limitations when providing health care advice and has been observed to misunderstand health care standards, lack personalization, and offer incorrect references; currently, the latest publicly available version (ChatGPT 3.5) also is unable to analyze clinical images.3,4

Reddit is an online social media forum that allows users to post questions and photographs to which anyone can reply and offer advice. Patients may find comfort in online communities where they can connect with others facing similar challenges related to their diagnosis. Within these communities, the responses often share users’ own lived experiences and offer support based on what has and has not worked for them. Prior research found that users intentionally seeking health information via Reddit are likely to implement the advice they receive even without verification of its credibility, suggesting a trust and receptibility to ideas offered on the platform.5 Furthermore, a study analyzing the dermatologic content of 17 dermatology related subreddits that had 1000 or more subscribers found that 70.6% of posts fell under the category of “seeking health/cosmetic advice.”6 Reddit users thus are vulnerable to receiving advice based on personal bias and exposing their health information to the public.

We hypothesized that ChatGPT would provide users with guidance that was more closely aligned with typical dermatologists’ advice due to its thorough analysis and compilation of diverse sources and recommendations available on the internet. We expected Reddit to yield recommendations of lesser quality and a diminished safety score, primarily due to the absence of credibility-vetting mechanisms and the influence of personal biases within the advice shared.

User-submitted posts to large dermatologic community Reddit forums representing a few of the most common skin conditions (r/eczema, r/acne, r/Folliculitis, r/SebDerm, r/Hidradenitis, r/keratosis, and r/Psoriasis) were retrospectively reviewed from January 2024 to March 2024. The most popular posts that did not include photographs were included in our study. Posts with photographs were excluded, as clinical images were not able to be uploaded to the publicly available ChatGPT 3.5. We collected real user questions about common skin conditions from Reddit forums and then asked ChatGPT to answer those same questions. We compared ChatGPT’s responses to the most upvoted Reddit comments to see how they matched up (eTable).

CT115006197-eTable

Each ChatGPT response and the top-rated Reddit comment were independently evaluated by a board certified dermatologist (S.A.) and a dermatology resident (A.H.K.). The quality of the ChatGPT and Reddit responses were determined by scoring the accuracy, appropriateness, safety consideration, and specificity on a 5-point Likert scale (1=low, 5=high). The 2 evaluators’ mean scores for each of the 4 categories were calculated based on adequate interrater reliability, which was tested using Cohen’s κ coefficient. Related-samples sign tests were used to compare ChatGPT and Reddit responses for each of the 4 categories. Analysis was completed using SPSS statistics software version 29.0 (IBM). The evaluators also were asked to provide qualitative feedback on the strengths and weaknesses of each response.

Our retrospective review yielded 20 total questions: 5 (25%) on atopic dermatitis, 4 (20%) on acne, 4 (20%) on hidradenitis suppurativa, 4 (20%) on psoriasis, 1 (5%) on folliculitis, 1 (5%) on keratosis pilaris, and 1 (5%) on seborrheic dermatitis. The number of posts was limited to 20 due to the extensive time required for grading each response. These 20 questions were selected from a larger pool of eligible posts based on factors such as clarity and relevance to common skin conditions. With regard to the types of questions that were asked, 6 (30%) were related to general management of a diagnosis, 5 (25%) were on treatment recommendations for symptom relief, 3 (15%) were on optimal utilization of current treatment regimens, 2 (10%) were on prescription side effects, 2 (10%) were on diagnosis presentation, 1 (5%) was on potential triggers of the diagnosis, and 1 (5%) was on natural treatment recommendations.

Mean (SD) evaluator scores for accuracy were significantly higher among ChatGPT responses compared with Reddit (4.63 [0.60] vs 2.60 [0.98])(P<.001). ChatGPT responses also were significantly higher for appropriateness compared with Reddit (4.55 [0.71] vs 2.58 [1.02])(P<.001) and safety consideration (4.88 [0.56] vs 2.80[0.97])(P <.001). There was no significant difference in mean specificity scores between ChatGPT and Reddit (4.25[1.02] vs 3.80 [0.70])(P=.096)(Figure).

Aflatooni-figure
FIGURE. Average ratings from 2 evaluators of Reddit and ChatGPT responses to 20 dermatology-related questions for accuracy, appropriateness, specificity, and safety.

For the Reddit responses, the weighted Cohen’s κ coefficient between the 2 evaluators was 0.200 (95% CI, –.089 to .489) for accuracy, 0.255 (95% CI, .014-.497) for appropriateness, 0.385 (95% CI, .176-.594) for safety consideration, and –0.024 (95% CI, –.177 to .129) for specificity. For the ChatGPT responses, the weighted Cohen’s κ coefficient between the 2 evaluators was 0.426 (95% CI, .122-.730) for accuracy, 0.571 (95% CI, .294-.849) for appropriateness, 0.655 (95% CI, .632-.678) for safety consideration, and 0.313 (95% CI, .043-.584) for specificity.

The strengths and weaknesses of the responses also were qualitatively analyzed. One commonly observed strength was ChatGPT’s frequent and appropriate recommendation for users to consult a dermatologist. In the case of atopic dermatitis—one of the more frequently asked about conditions—ChatGPT consistently emphasized evidence-based strategies such as gentle skin care and moisturization, reflecting alignment with clinical guidelines. Additionally, a common weakness of both ChatGPT and Reddit responses generally was the lack of personalized guidance and comprehensive discussion of the risks and benefits of specific treatments. It also was noted that neither platform consistently explored differential diagnoses—for example, distinguishing atopic dermatitis from conditions such as allergic contact dermatitis—limiting the diagnostic depth of the responses.

ChatGPT and Reddit can provide patients with quick and accessible health information for various dermatologic concerns. The results of our study demonstrated a significantly higher level of accuracy, appropriateness, and safety of responses generated by ChatGPT compared with human-generated responses on Reddit (P<.001). Both platforms offered similarly specific responses to user inquiries, demonstrating ChatGPT’s ability to comprehend user questions and draw from publicly available texts and Reddit users’ contributing insights based on their own first-hand experiences.

Reddit’s dermatologic forums often feature personal anecdotes and unique treatments described by individual users. Although specific to particular dermatologic concerns, such advice lacks an evidence-based standard of care. With the noted inherent trust of patients seeking guidance within Reddit communities, patients may follow unhelpful or potentially dangerous medical advice.5 A study examining 300 user-submitted posts on popular Reddit dermatology forums during the COVID-19 pandemic found that the mean scores for top-rated comments’ potential to be misleading or dangerous was 2.33 out of 5 on a Likert scale (95% CI, 2.18- 2.48).7 Dermatologists should be aware of the potential risks associated with dermatologic advice offered on Reddit and should caution patients against relying solely on this information without consulting a qualified dermatologist first.

Reddit’s open-forum design provides licensed dermatologists with the opportunity to disseminate evidence based information regarding dermatologic conditions. Currently, there is a subreddit (r/AskDocs) that allows users to post medical questions that can be answered by moderator-verified physicians. Participation from dermatologists in online communities such as this can improve the quality of dermatologic information shared online, combat misinformation, and promote safe skin care practices.

ChatGPT offers more accurate, appropriate, and safe information compared to Reddit responses, but its answers lack personalization. In a clinical setting, a personalized treatment plan from a physician can be tailored with a comprehensive discussion of the risks and benefits. Further, clinical settings allow for diagnosis and confirmation via biopsy and meticulous history taking to ensure that the diagnosis and treatment plan are accurate. While ChatGPT may be an option for seeking basic advice on dermatologic conditions, a licensed dermatologist should always be consulted for proper medical advice. Services such as telehealth may be another option to for patients with limited access to care.

Since ChatGPT 3.5 does not support the ability to upload images, our study acknowledges a limitation regarding the inclusion of Reddit posts containing photographs. Images can improve the response quality from both Reddit users and ChatGPT. While the updated ChatGPT 4o is capable of processing images, it requires a monthly subscription fee. The free version was chosen for use in this study, as this may reflect the most likely version that patients of low socioeconomic status would utilize to access dermatologic care; however, there is potential for growth and improvement of ChatGPT’s capability in providing medical advice.

This study compared the strengths and limitations of ChatGPT’s and Reddit’s responses to common dermatologic inquiries. ChatGPT and Reddit both show potential to be helpful sources of dermatologic health information; however, their current versions have many limitations and require caution and careful examination by patients of the guidance provided. Clinicians should be aware of these limitations when advising patients and emphasize the importance of consulting a licensed dermatologist for personalized, evidence-based care. For the best medical advice, it is always advisable to consult with a licensed dermatologist.

References
  1. Roumeliotis KI, Tselikas ND. ChatGPT and open-AI models: a preliminary review. Future Internet. 2023;15:192. doi:10.3390/fi15060192
  2. Iqbal U, Lee LTJ, Rahmanti AR, et al. Can large language models provide secondary reliable opinion on treatment options for dermatological diseases? J Am Med Inform Assoc. 2024;31:1341-1347. doi:10.1093/jamia/ocae067
  3. Whiles BB, Bird VG, Canales BK, et al. Caution! AI bot has entered the patient chat: ChatGPT has limitations in providing accurate urologic healthcare advice. Urology. 2023;180:278-284. doi:10.1016/j.urology.2023.07.010
  4. Nastasi AJ, Courtright KR, Halpern SD, et al. A vignette-based evaluation of ChatGPT’s ability to provide appropriate and equitable medical advice across care contexts. Sci Rep. 2023;13:17885. doi:10.1038/s41598-023-45223-y
  5. Record RA, Silberman WR, Santiago JE, et al. I sought it, I Reddit: examining health information engagement behaviors among Reddit users. J Health Commun. 2018;23:470-476. doi:10.1080/1081073 0.2018.1465493
  6. Buntinx-Krieg T, Caravaglio J, Domozych R, et al. Dermatology on Reddit: elucidating trends in dermatologic communications on the world wide web. Dermatol Online J. 2017;23:13030/qt9dr1f7x6.
  7. Aboul-Fettouh N, Lee KP, Kash N, et al. Social media and dermatology during the COVID-19 pandemic: analyzing usersubmitted posts seeking dermatologic advice on Reddit. Cureus. 2023;15:E33720. doi:10.7759/cureus.33720
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From the Morsani College of Medicine, University of South Florida, Tampa. Emily Coughlin is from the Department of Medical Education and Drs. Lipman, Kucharik, and Albers are from the Department of Dermatology and Cutaneous Surgery.

The authors have no relevant financial disclosure to report.

Correspondence: Shaliz Aflatooni, BS, USF Health Morsani College of Medicine, 560 Channelside Dr, Tampa, FL 33602 (aflatooni@usf.edu).

Cutis. 2025 June;115(6):197-199, E3. doi:10.12788/cutis.1222

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From the Morsani College of Medicine, University of South Florida, Tampa. Emily Coughlin is from the Department of Medical Education and Drs. Lipman, Kucharik, and Albers are from the Department of Dermatology and Cutaneous Surgery.

The authors have no relevant financial disclosure to report.

Correspondence: Shaliz Aflatooni, BS, USF Health Morsani College of Medicine, 560 Channelside Dr, Tampa, FL 33602 (aflatooni@usf.edu).

Cutis. 2025 June;115(6):197-199, E3. doi:10.12788/cutis.1222

Author and Disclosure Information

From the Morsani College of Medicine, University of South Florida, Tampa. Emily Coughlin is from the Department of Medical Education and Drs. Lipman, Kucharik, and Albers are from the Department of Dermatology and Cutaneous Surgery.

The authors have no relevant financial disclosure to report.

Correspondence: Shaliz Aflatooni, BS, USF Health Morsani College of Medicine, 560 Channelside Dr, Tampa, FL 33602 (aflatooni@usf.edu).

Cutis. 2025 June;115(6):197-199, E3. doi:10.12788/cutis.1222

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To the Editor:

Online resources that are convenient and affordable play a crucial role in mitigating health inequality and improving patient access to health care information; however, the benefits are limited by the quality of information available, as medical misinformation can lead to patients engaging in harmful practices, making dangerous decisions, and even avoiding safe and effective treatments. In this study, we aimed to assess and compare the quality of patient guidance on dermatologic care generated by ChatGPT vs Reddit based on accuracy, appropriateness, and safety. It is essential to assess the quality and reliability of online health information to support patients in making informed decisions about their health.

The emergence and advancement of artificial intelligence and large language models such as ChatGPT present a new method for patients to access health care advice. ChatGPT can engage in conversation by accessing information from existing publicly available data on the internet, including books and websites, up to the year 2023 and providing humanlike responses with context.1 ChatGPT’s access to a breadth of online evidence-based literature ensures the dissemination of quality information that is quick and without inherent bias, offering the potential to more closely align with health care professionals. ChatGPT’s use in dermatology by patients has shown efficacy, with a 98.87% approval rate by dermatologists scoring its ability to recommend appropriate medication for common dermatologic conditions.2 However, ChatGPT has limitations when providing health care advice and has been observed to misunderstand health care standards, lack personalization, and offer incorrect references; currently, the latest publicly available version (ChatGPT 3.5) also is unable to analyze clinical images.3,4

Reddit is an online social media forum that allows users to post questions and photographs to which anyone can reply and offer advice. Patients may find comfort in online communities where they can connect with others facing similar challenges related to their diagnosis. Within these communities, the responses often share users’ own lived experiences and offer support based on what has and has not worked for them. Prior research found that users intentionally seeking health information via Reddit are likely to implement the advice they receive even without verification of its credibility, suggesting a trust and receptibility to ideas offered on the platform.5 Furthermore, a study analyzing the dermatologic content of 17 dermatology related subreddits that had 1000 or more subscribers found that 70.6% of posts fell under the category of “seeking health/cosmetic advice.”6 Reddit users thus are vulnerable to receiving advice based on personal bias and exposing their health information to the public.

We hypothesized that ChatGPT would provide users with guidance that was more closely aligned with typical dermatologists’ advice due to its thorough analysis and compilation of diverse sources and recommendations available on the internet. We expected Reddit to yield recommendations of lesser quality and a diminished safety score, primarily due to the absence of credibility-vetting mechanisms and the influence of personal biases within the advice shared.

User-submitted posts to large dermatologic community Reddit forums representing a few of the most common skin conditions (r/eczema, r/acne, r/Folliculitis, r/SebDerm, r/Hidradenitis, r/keratosis, and r/Psoriasis) were retrospectively reviewed from January 2024 to March 2024. The most popular posts that did not include photographs were included in our study. Posts with photographs were excluded, as clinical images were not able to be uploaded to the publicly available ChatGPT 3.5. We collected real user questions about common skin conditions from Reddit forums and then asked ChatGPT to answer those same questions. We compared ChatGPT’s responses to the most upvoted Reddit comments to see how they matched up (eTable).

CT115006197-eTable

Each ChatGPT response and the top-rated Reddit comment were independently evaluated by a board certified dermatologist (S.A.) and a dermatology resident (A.H.K.). The quality of the ChatGPT and Reddit responses were determined by scoring the accuracy, appropriateness, safety consideration, and specificity on a 5-point Likert scale (1=low, 5=high). The 2 evaluators’ mean scores for each of the 4 categories were calculated based on adequate interrater reliability, which was tested using Cohen’s κ coefficient. Related-samples sign tests were used to compare ChatGPT and Reddit responses for each of the 4 categories. Analysis was completed using SPSS statistics software version 29.0 (IBM). The evaluators also were asked to provide qualitative feedback on the strengths and weaknesses of each response.

Our retrospective review yielded 20 total questions: 5 (25%) on atopic dermatitis, 4 (20%) on acne, 4 (20%) on hidradenitis suppurativa, 4 (20%) on psoriasis, 1 (5%) on folliculitis, 1 (5%) on keratosis pilaris, and 1 (5%) on seborrheic dermatitis. The number of posts was limited to 20 due to the extensive time required for grading each response. These 20 questions were selected from a larger pool of eligible posts based on factors such as clarity and relevance to common skin conditions. With regard to the types of questions that were asked, 6 (30%) were related to general management of a diagnosis, 5 (25%) were on treatment recommendations for symptom relief, 3 (15%) were on optimal utilization of current treatment regimens, 2 (10%) were on prescription side effects, 2 (10%) were on diagnosis presentation, 1 (5%) was on potential triggers of the diagnosis, and 1 (5%) was on natural treatment recommendations.

Mean (SD) evaluator scores for accuracy were significantly higher among ChatGPT responses compared with Reddit (4.63 [0.60] vs 2.60 [0.98])(P<.001). ChatGPT responses also were significantly higher for appropriateness compared with Reddit (4.55 [0.71] vs 2.58 [1.02])(P<.001) and safety consideration (4.88 [0.56] vs 2.80[0.97])(P <.001). There was no significant difference in mean specificity scores between ChatGPT and Reddit (4.25[1.02] vs 3.80 [0.70])(P=.096)(Figure).

Aflatooni-figure
FIGURE. Average ratings from 2 evaluators of Reddit and ChatGPT responses to 20 dermatology-related questions for accuracy, appropriateness, specificity, and safety.

For the Reddit responses, the weighted Cohen’s κ coefficient between the 2 evaluators was 0.200 (95% CI, –.089 to .489) for accuracy, 0.255 (95% CI, .014-.497) for appropriateness, 0.385 (95% CI, .176-.594) for safety consideration, and –0.024 (95% CI, –.177 to .129) for specificity. For the ChatGPT responses, the weighted Cohen’s κ coefficient between the 2 evaluators was 0.426 (95% CI, .122-.730) for accuracy, 0.571 (95% CI, .294-.849) for appropriateness, 0.655 (95% CI, .632-.678) for safety consideration, and 0.313 (95% CI, .043-.584) for specificity.

The strengths and weaknesses of the responses also were qualitatively analyzed. One commonly observed strength was ChatGPT’s frequent and appropriate recommendation for users to consult a dermatologist. In the case of atopic dermatitis—one of the more frequently asked about conditions—ChatGPT consistently emphasized evidence-based strategies such as gentle skin care and moisturization, reflecting alignment with clinical guidelines. Additionally, a common weakness of both ChatGPT and Reddit responses generally was the lack of personalized guidance and comprehensive discussion of the risks and benefits of specific treatments. It also was noted that neither platform consistently explored differential diagnoses—for example, distinguishing atopic dermatitis from conditions such as allergic contact dermatitis—limiting the diagnostic depth of the responses.

ChatGPT and Reddit can provide patients with quick and accessible health information for various dermatologic concerns. The results of our study demonstrated a significantly higher level of accuracy, appropriateness, and safety of responses generated by ChatGPT compared with human-generated responses on Reddit (P<.001). Both platforms offered similarly specific responses to user inquiries, demonstrating ChatGPT’s ability to comprehend user questions and draw from publicly available texts and Reddit users’ contributing insights based on their own first-hand experiences.

Reddit’s dermatologic forums often feature personal anecdotes and unique treatments described by individual users. Although specific to particular dermatologic concerns, such advice lacks an evidence-based standard of care. With the noted inherent trust of patients seeking guidance within Reddit communities, patients may follow unhelpful or potentially dangerous medical advice.5 A study examining 300 user-submitted posts on popular Reddit dermatology forums during the COVID-19 pandemic found that the mean scores for top-rated comments’ potential to be misleading or dangerous was 2.33 out of 5 on a Likert scale (95% CI, 2.18- 2.48).7 Dermatologists should be aware of the potential risks associated with dermatologic advice offered on Reddit and should caution patients against relying solely on this information without consulting a qualified dermatologist first.

Reddit’s open-forum design provides licensed dermatologists with the opportunity to disseminate evidence based information regarding dermatologic conditions. Currently, there is a subreddit (r/AskDocs) that allows users to post medical questions that can be answered by moderator-verified physicians. Participation from dermatologists in online communities such as this can improve the quality of dermatologic information shared online, combat misinformation, and promote safe skin care practices.

ChatGPT offers more accurate, appropriate, and safe information compared to Reddit responses, but its answers lack personalization. In a clinical setting, a personalized treatment plan from a physician can be tailored with a comprehensive discussion of the risks and benefits. Further, clinical settings allow for diagnosis and confirmation via biopsy and meticulous history taking to ensure that the diagnosis and treatment plan are accurate. While ChatGPT may be an option for seeking basic advice on dermatologic conditions, a licensed dermatologist should always be consulted for proper medical advice. Services such as telehealth may be another option to for patients with limited access to care.

Since ChatGPT 3.5 does not support the ability to upload images, our study acknowledges a limitation regarding the inclusion of Reddit posts containing photographs. Images can improve the response quality from both Reddit users and ChatGPT. While the updated ChatGPT 4o is capable of processing images, it requires a monthly subscription fee. The free version was chosen for use in this study, as this may reflect the most likely version that patients of low socioeconomic status would utilize to access dermatologic care; however, there is potential for growth and improvement of ChatGPT’s capability in providing medical advice.

This study compared the strengths and limitations of ChatGPT’s and Reddit’s responses to common dermatologic inquiries. ChatGPT and Reddit both show potential to be helpful sources of dermatologic health information; however, their current versions have many limitations and require caution and careful examination by patients of the guidance provided. Clinicians should be aware of these limitations when advising patients and emphasize the importance of consulting a licensed dermatologist for personalized, evidence-based care. For the best medical advice, it is always advisable to consult with a licensed dermatologist.

To the Editor:

Online resources that are convenient and affordable play a crucial role in mitigating health inequality and improving patient access to health care information; however, the benefits are limited by the quality of information available, as medical misinformation can lead to patients engaging in harmful practices, making dangerous decisions, and even avoiding safe and effective treatments. In this study, we aimed to assess and compare the quality of patient guidance on dermatologic care generated by ChatGPT vs Reddit based on accuracy, appropriateness, and safety. It is essential to assess the quality and reliability of online health information to support patients in making informed decisions about their health.

The emergence and advancement of artificial intelligence and large language models such as ChatGPT present a new method for patients to access health care advice. ChatGPT can engage in conversation by accessing information from existing publicly available data on the internet, including books and websites, up to the year 2023 and providing humanlike responses with context.1 ChatGPT’s access to a breadth of online evidence-based literature ensures the dissemination of quality information that is quick and without inherent bias, offering the potential to more closely align with health care professionals. ChatGPT’s use in dermatology by patients has shown efficacy, with a 98.87% approval rate by dermatologists scoring its ability to recommend appropriate medication for common dermatologic conditions.2 However, ChatGPT has limitations when providing health care advice and has been observed to misunderstand health care standards, lack personalization, and offer incorrect references; currently, the latest publicly available version (ChatGPT 3.5) also is unable to analyze clinical images.3,4

Reddit is an online social media forum that allows users to post questions and photographs to which anyone can reply and offer advice. Patients may find comfort in online communities where they can connect with others facing similar challenges related to their diagnosis. Within these communities, the responses often share users’ own lived experiences and offer support based on what has and has not worked for them. Prior research found that users intentionally seeking health information via Reddit are likely to implement the advice they receive even without verification of its credibility, suggesting a trust and receptibility to ideas offered on the platform.5 Furthermore, a study analyzing the dermatologic content of 17 dermatology related subreddits that had 1000 or more subscribers found that 70.6% of posts fell under the category of “seeking health/cosmetic advice.”6 Reddit users thus are vulnerable to receiving advice based on personal bias and exposing their health information to the public.

We hypothesized that ChatGPT would provide users with guidance that was more closely aligned with typical dermatologists’ advice due to its thorough analysis and compilation of diverse sources and recommendations available on the internet. We expected Reddit to yield recommendations of lesser quality and a diminished safety score, primarily due to the absence of credibility-vetting mechanisms and the influence of personal biases within the advice shared.

User-submitted posts to large dermatologic community Reddit forums representing a few of the most common skin conditions (r/eczema, r/acne, r/Folliculitis, r/SebDerm, r/Hidradenitis, r/keratosis, and r/Psoriasis) were retrospectively reviewed from January 2024 to March 2024. The most popular posts that did not include photographs were included in our study. Posts with photographs were excluded, as clinical images were not able to be uploaded to the publicly available ChatGPT 3.5. We collected real user questions about common skin conditions from Reddit forums and then asked ChatGPT to answer those same questions. We compared ChatGPT’s responses to the most upvoted Reddit comments to see how they matched up (eTable).

CT115006197-eTable

Each ChatGPT response and the top-rated Reddit comment were independently evaluated by a board certified dermatologist (S.A.) and a dermatology resident (A.H.K.). The quality of the ChatGPT and Reddit responses were determined by scoring the accuracy, appropriateness, safety consideration, and specificity on a 5-point Likert scale (1=low, 5=high). The 2 evaluators’ mean scores for each of the 4 categories were calculated based on adequate interrater reliability, which was tested using Cohen’s κ coefficient. Related-samples sign tests were used to compare ChatGPT and Reddit responses for each of the 4 categories. Analysis was completed using SPSS statistics software version 29.0 (IBM). The evaluators also were asked to provide qualitative feedback on the strengths and weaknesses of each response.

Our retrospective review yielded 20 total questions: 5 (25%) on atopic dermatitis, 4 (20%) on acne, 4 (20%) on hidradenitis suppurativa, 4 (20%) on psoriasis, 1 (5%) on folliculitis, 1 (5%) on keratosis pilaris, and 1 (5%) on seborrheic dermatitis. The number of posts was limited to 20 due to the extensive time required for grading each response. These 20 questions were selected from a larger pool of eligible posts based on factors such as clarity and relevance to common skin conditions. With regard to the types of questions that were asked, 6 (30%) were related to general management of a diagnosis, 5 (25%) were on treatment recommendations for symptom relief, 3 (15%) were on optimal utilization of current treatment regimens, 2 (10%) were on prescription side effects, 2 (10%) were on diagnosis presentation, 1 (5%) was on potential triggers of the diagnosis, and 1 (5%) was on natural treatment recommendations.

Mean (SD) evaluator scores for accuracy were significantly higher among ChatGPT responses compared with Reddit (4.63 [0.60] vs 2.60 [0.98])(P<.001). ChatGPT responses also were significantly higher for appropriateness compared with Reddit (4.55 [0.71] vs 2.58 [1.02])(P<.001) and safety consideration (4.88 [0.56] vs 2.80[0.97])(P <.001). There was no significant difference in mean specificity scores between ChatGPT and Reddit (4.25[1.02] vs 3.80 [0.70])(P=.096)(Figure).

Aflatooni-figure
FIGURE. Average ratings from 2 evaluators of Reddit and ChatGPT responses to 20 dermatology-related questions for accuracy, appropriateness, specificity, and safety.

For the Reddit responses, the weighted Cohen’s κ coefficient between the 2 evaluators was 0.200 (95% CI, –.089 to .489) for accuracy, 0.255 (95% CI, .014-.497) for appropriateness, 0.385 (95% CI, .176-.594) for safety consideration, and –0.024 (95% CI, –.177 to .129) for specificity. For the ChatGPT responses, the weighted Cohen’s κ coefficient between the 2 evaluators was 0.426 (95% CI, .122-.730) for accuracy, 0.571 (95% CI, .294-.849) for appropriateness, 0.655 (95% CI, .632-.678) for safety consideration, and 0.313 (95% CI, .043-.584) for specificity.

The strengths and weaknesses of the responses also were qualitatively analyzed. One commonly observed strength was ChatGPT’s frequent and appropriate recommendation for users to consult a dermatologist. In the case of atopic dermatitis—one of the more frequently asked about conditions—ChatGPT consistently emphasized evidence-based strategies such as gentle skin care and moisturization, reflecting alignment with clinical guidelines. Additionally, a common weakness of both ChatGPT and Reddit responses generally was the lack of personalized guidance and comprehensive discussion of the risks and benefits of specific treatments. It also was noted that neither platform consistently explored differential diagnoses—for example, distinguishing atopic dermatitis from conditions such as allergic contact dermatitis—limiting the diagnostic depth of the responses.

ChatGPT and Reddit can provide patients with quick and accessible health information for various dermatologic concerns. The results of our study demonstrated a significantly higher level of accuracy, appropriateness, and safety of responses generated by ChatGPT compared with human-generated responses on Reddit (P<.001). Both platforms offered similarly specific responses to user inquiries, demonstrating ChatGPT’s ability to comprehend user questions and draw from publicly available texts and Reddit users’ contributing insights based on their own first-hand experiences.

Reddit’s dermatologic forums often feature personal anecdotes and unique treatments described by individual users. Although specific to particular dermatologic concerns, such advice lacks an evidence-based standard of care. With the noted inherent trust of patients seeking guidance within Reddit communities, patients may follow unhelpful or potentially dangerous medical advice.5 A study examining 300 user-submitted posts on popular Reddit dermatology forums during the COVID-19 pandemic found that the mean scores for top-rated comments’ potential to be misleading or dangerous was 2.33 out of 5 on a Likert scale (95% CI, 2.18- 2.48).7 Dermatologists should be aware of the potential risks associated with dermatologic advice offered on Reddit and should caution patients against relying solely on this information without consulting a qualified dermatologist first.

Reddit’s open-forum design provides licensed dermatologists with the opportunity to disseminate evidence based information regarding dermatologic conditions. Currently, there is a subreddit (r/AskDocs) that allows users to post medical questions that can be answered by moderator-verified physicians. Participation from dermatologists in online communities such as this can improve the quality of dermatologic information shared online, combat misinformation, and promote safe skin care practices.

ChatGPT offers more accurate, appropriate, and safe information compared to Reddit responses, but its answers lack personalization. In a clinical setting, a personalized treatment plan from a physician can be tailored with a comprehensive discussion of the risks and benefits. Further, clinical settings allow for diagnosis and confirmation via biopsy and meticulous history taking to ensure that the diagnosis and treatment plan are accurate. While ChatGPT may be an option for seeking basic advice on dermatologic conditions, a licensed dermatologist should always be consulted for proper medical advice. Services such as telehealth may be another option to for patients with limited access to care.

Since ChatGPT 3.5 does not support the ability to upload images, our study acknowledges a limitation regarding the inclusion of Reddit posts containing photographs. Images can improve the response quality from both Reddit users and ChatGPT. While the updated ChatGPT 4o is capable of processing images, it requires a monthly subscription fee. The free version was chosen for use in this study, as this may reflect the most likely version that patients of low socioeconomic status would utilize to access dermatologic care; however, there is potential for growth and improvement of ChatGPT’s capability in providing medical advice.

This study compared the strengths and limitations of ChatGPT’s and Reddit’s responses to common dermatologic inquiries. ChatGPT and Reddit both show potential to be helpful sources of dermatologic health information; however, their current versions have many limitations and require caution and careful examination by patients of the guidance provided. Clinicians should be aware of these limitations when advising patients and emphasize the importance of consulting a licensed dermatologist for personalized, evidence-based care. For the best medical advice, it is always advisable to consult with a licensed dermatologist.

References
  1. Roumeliotis KI, Tselikas ND. ChatGPT and open-AI models: a preliminary review. Future Internet. 2023;15:192. doi:10.3390/fi15060192
  2. Iqbal U, Lee LTJ, Rahmanti AR, et al. Can large language models provide secondary reliable opinion on treatment options for dermatological diseases? J Am Med Inform Assoc. 2024;31:1341-1347. doi:10.1093/jamia/ocae067
  3. Whiles BB, Bird VG, Canales BK, et al. Caution! AI bot has entered the patient chat: ChatGPT has limitations in providing accurate urologic healthcare advice. Urology. 2023;180:278-284. doi:10.1016/j.urology.2023.07.010
  4. Nastasi AJ, Courtright KR, Halpern SD, et al. A vignette-based evaluation of ChatGPT’s ability to provide appropriate and equitable medical advice across care contexts. Sci Rep. 2023;13:17885. doi:10.1038/s41598-023-45223-y
  5. Record RA, Silberman WR, Santiago JE, et al. I sought it, I Reddit: examining health information engagement behaviors among Reddit users. J Health Commun. 2018;23:470-476. doi:10.1080/1081073 0.2018.1465493
  6. Buntinx-Krieg T, Caravaglio J, Domozych R, et al. Dermatology on Reddit: elucidating trends in dermatologic communications on the world wide web. Dermatol Online J. 2017;23:13030/qt9dr1f7x6.
  7. Aboul-Fettouh N, Lee KP, Kash N, et al. Social media and dermatology during the COVID-19 pandemic: analyzing usersubmitted posts seeking dermatologic advice on Reddit. Cureus. 2023;15:E33720. doi:10.7759/cureus.33720
References
  1. Roumeliotis KI, Tselikas ND. ChatGPT and open-AI models: a preliminary review. Future Internet. 2023;15:192. doi:10.3390/fi15060192
  2. Iqbal U, Lee LTJ, Rahmanti AR, et al. Can large language models provide secondary reliable opinion on treatment options for dermatological diseases? J Am Med Inform Assoc. 2024;31:1341-1347. doi:10.1093/jamia/ocae067
  3. Whiles BB, Bird VG, Canales BK, et al. Caution! AI bot has entered the patient chat: ChatGPT has limitations in providing accurate urologic healthcare advice. Urology. 2023;180:278-284. doi:10.1016/j.urology.2023.07.010
  4. Nastasi AJ, Courtright KR, Halpern SD, et al. A vignette-based evaluation of ChatGPT’s ability to provide appropriate and equitable medical advice across care contexts. Sci Rep. 2023;13:17885. doi:10.1038/s41598-023-45223-y
  5. Record RA, Silberman WR, Santiago JE, et al. I sought it, I Reddit: examining health information engagement behaviors among Reddit users. J Health Commun. 2018;23:470-476. doi:10.1080/1081073 0.2018.1465493
  6. Buntinx-Krieg T, Caravaglio J, Domozych R, et al. Dermatology on Reddit: elucidating trends in dermatologic communications on the world wide web. Dermatol Online J. 2017;23:13030/qt9dr1f7x6.
  7. Aboul-Fettouh N, Lee KP, Kash N, et al. Social media and dermatology during the COVID-19 pandemic: analyzing usersubmitted posts seeking dermatologic advice on Reddit. Cureus. 2023;15:E33720. doi:10.7759/cureus.33720
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Comparing the Quality of Patient Guidance on Dermatologic Care Generated by ChatGPT vs Reddit

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  • ChatGPT and Reddit are free, convenient, and accessible online resources that patients may use for guidance on dermatologic care.
  • Dermatologists should be aware of the potential risks associated with obtaining medical guidance from ChatGPT and Reddit and caution patients on them.
  • An increasing presence of dermatologists on online public forums can increase the dissemination of reliable health care information.
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Impact of Multisite Patient Education on Pharmacotherapy for Veterans With Alcohol Use Disorder

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Impact of Multisite Patient Education on Pharmacotherapy for Veterans With Alcohol Use Disorder

Excessive alcohol use is one of the leading preventable causes of death in the United States, responsible for about 178,000 deaths annually and an average of 488 daily deaths in 2020 and 2021.1Alcohol-related deaths increased by 49% between 2006 and 2019.2 This trend continued during the COVID-19 pandemic, with death certificates that listed alcohol increasing by > 25% from 2019 to 2020, and another 10% in 2021.3 This increase of alcohol-related deaths includes those as a direct result of chronic alcohol use, such as alcoholic cardiomyopathy, alcoholic hepatitis and cirrhosis, and alcohol-induced pancreatitis, as well as a result of acute use such as alcohol poisoning, suicide by exposure to alcohol, and alcohol-impaired driving fatalities.4

Excessive alcohol consumption poses other serious risks, including cases when intake is abruptly reduced without proper management. Alcohol withdrawal syndrome (AWS) can vary in severity, with potentially life-threatening complications such as hallucinations, seizures, and delirium tremens.5

These risks highlight the importance of professional intervention and support, not only to mitigate risks associated with AWS, but provide a pathway towards recovery from alcohol use disorder (AUD).

According to the 2022 National Survey on Drug Use and Health, 28.8 million US adults had AUD in the prior year, yet only 7.6% of these individuals received treatment and an even smaller group (2.2%) received medication-assisted treatment for alcohol.6,7 This is despite American Psychiatric Association guidelines for the pharmacological treatment of patients with AUD, including the use of naltrexone, acamprosate, disulfiram, topiramate, or gabapentin, depending on therapy goals, past medication trials, medication contraindications, and patient preference.8 Several of these medications are approved by the US Food and Drug Administration (FDA) for the treatment of AUD and have support for effectiveness from randomized controlled trials and meta-analyses.9-11

Clinical practice guidelines for the management of substance use disorders (SUDs) from the US Department of Veterans Affairs (VA) and US Department of Defense have strong recommendations for naltrexone and topiramate as first-line pharmacotherapies for moderate to severe AUD. Acamprosate and disulfiram are weak recommendations as alternative options. Gabapentin is a weak recommendation for cases where first-line treatments are contraindicated or ineffective. The guidelines emphasize the importance of a comprehensive approach to AUD treatment, including psychosocial interventions in addition to pharmacotherapy.12

A 2023 national survey found veterans reported higher alcohol consumption than nonveterans.13 At the end of fiscal year 2023, > 4.4 million veterans—6% of Veterans Health Administration patients—had been diagnosed with AUD.14 However, > 87% of these patients nationally, and 88% of Veterans Integrated Service Network (VISN) 21 patients, were not receiving naltrexone, acamprosate, disulfiram, or topiramate as part of their treatment. The VA Academic Detailing Service (ADS) now includes AUD pharmacotherapy as a campaign focus, highlighting its importance. The ADS is a pharmacy educational outreach program that uses unbiased clinical guidelines to promote aligning prescribing behavior with best practices. Academic detailing methods include speaking with health care practitioners (HCPs), and direct-to-consumer (DTC) patient education.

ADS campaigns include DTC educational handouts. Past ADS projects and research using DTC have demonstrated a significant improvement in outcomes and positively influencing patients’ pharmacotherapy treatment. 15,16 A VA quality improvement project found a positive correlation between the initiation of AUD pharmacotherapy and engagement with mental health care following the distribution of AUD DTC patient education. 17 This project aimed to apply the same principles of prior research to explore the use of DTC across multiple facilities within VISN 21 to increase AUD pharmacotherapy. VISN 21 includes VA facilities and clinics across the Pacific Islands, Nevada, and California and serves about 350,000 veterans.

METHODS

A prospective cohort of VISN 21 veterans with or at high risk for AUD was identified using the VA ADS AUD Dashboard. The cohort included those not on acamprosate, disulfiram, naltrexone, topiramate, or gabapentin for treatment of AUD and had an elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score of ≥ 6 (high risk) with an AUD diagnosis or ≥ 8 (severe risk) without a diagnosis. The AUDIT-C scores used in the dashboard are supported by the VA AUD clinician guide as the minimum scores when AUD pharmacotherapy should be offered to patients.18 Prescriptions filled outside the VA were not included in this dashboard.

Data and patient information were collected using the VA Corporate Data Warehouse. To be eligible, veterans needed a valid mailing address within the VISN 21 region and a primary care, mental health, or SUD clinician prescriber visit scheduled between October 1, 2023, and January 31, 2024. Veterans were excluded if they were in hospice, had a 1-year mortality risk score > 50% based on their Care Assessment Need (CAN) score, or facility leadership opted out of project involvement. Patients with both severe renal and hepatic impairments were excluded because they were ineligible for AUD pharmacotherapy. However, veterans with either renal or hepatic impairment (but not both) were included, as they could be potential candidates for ≥ 1 AUD pharmacotherapy option.

Initial correspondence with facilities was initiated through local academic detailers. A local champion was identified for the 1 facility without an academic detailer. Facilities could opt in or out of the project. Approval was provided by the local pharmacy and therapeutics committee, pharmacy, primary care, or psychiatry leadership. Approval process and clinician involvement varied by site.

Education

The selected AUD patient education was designed and approved by the national VA ADS (eappendix). The DTC patient education provided general knowledge about alcohol, including what constitutes a standard amount of alcohol, what is considered heavy drinking, risks of heavy drinking, creating a plan with a clinician to reduce and manage withdrawal symptoms, and additional resources. The DTC was accompanied by a cover letter that included a local facility contact number.

A centralized mailing facility was used for all materials. VA Northern California Health Care System provided the funding to cover the cost of postage. The list of veterans to be contacted was updated on a rolling basis and DTC education was mailed 2 weeks prior to their scheduled prescriber visit.

The eligible cohort of 1260 veterans received DTC education. A comparator group of 2048 veterans that did not receive DTC education was obtained retrospectively by using the same inclusion and exclusion criteria with a scheduled primary care, mental health, or SUD HCP visit from October 1, 2022, to January 31, 2023. The outcomes assessed were within 30 days of the scheduled visit, with the primary outcome as the initiation of AUD-related pharmacotherapy and the secondary outcome as the placement of a consultation for mental health or SUD services. Any consultations sent to Behavioral Health, Addiction, Mental Health, Psychiatric, and SUD services following the HCP visit, within the specified time frame, were used for the secondary outcome.

Matching and Analysis

A 1-to-1 nearest neighbor propensity score (PS) matching without replacement was used to pair the 1260 veterans from the intervention group with similarly scored comparator group veterans for a PS-matched final dataset of 2520 veterans. The PS model was a multivariate logistic regression with the outcome being exposure and comparator group status. Baseline characteristics used in the PS model were age, birth sex, race, facility of care, baseline AUDIT-C score, and days between project start and scheduled appointment. Covariate imbalance for the PS-matched sample was assessed to ensure the standardized mean difference for all covariates fell under a 0.1 threshold (Figure).19

0525FED-eAUD-F1

A frequency table was provided to compare the discrete distributions of the baseline characteristics in the intervention and comparator groups. Logistic regression analysis was performed to evaluate the association between DTC education exposure and pharmacotherapy initiation, while controlling for potential confounders. Univariate and multivariate P value results for each variable included in the model were reported along with the multivariate odds ratios (ORs) and their associated 95% CIs. Logistic regression analyses were run for both outcomes. Each model included the exposure and comparator group status as well as the baseline characteristics included in the PS model. Statistical significance was set at P < .05. All statistical analyses were performed with R version 4.2.1.

RESULTS

Two of 7 VISN 21 sites did not participate, and 3 had restrictions on participation. DTC education was mailed about 2 weeks prior to scheduled visit for 1260 veterans; 53.6% identified as White, 37.6% were aged 41 to 60 years, and 79.2% had an AUDIT-C ≥ 8 (Table 1). Of those mailed education, there were 173 no-show appointments (13.7%). Thirty-two veterans (2.5%) in the DTC group and 33 veterans (2.6%) in the comparator group received an AUD-related pharmacotherapy prescription (P = .88) (Table 2). One hundred seventy-one veterans (13.6%) in the DTC group and 160 veterans (12.7%) in the comparator group had a consult placed for mental health or SUD services within 30 days of their appointment (P = .59) (Table 3).

0525FED-eAUD-T10525FED-eAUD-T20525FED-eAUD-T3

DISCUSSION

This project did not yield statistically significant differences in either the primary or secondary outcomes within the 30-day follow-up window and found limited impact from the DTC educational outreach to veterans. The percentage of veterans that received AUD-related pharmacotherapy or consultations for mental health or SUD services was similarly low in the DTC and comparator groups. These findings suggest that although DTC education may raise awareness, it may not be sufficient on its own to drive changes in prescribing behavior or referral patterns without system-level support.

Addiction is a complex disease faced with stigma and requiring readiness by both the HCP and patient to move forward in support and treatment. The consequences of stigma can be severe: the more stigma perceived by a person with AUD, the less likely they are to seek treatment.20 Stigma may exist even within HCPs and may lead to compromised care including shortened visits, less engagement, and less empathy.19 Cultural attitude towards alcohol use and intoxication can also be influenced through a wide range of sources including social media, movies, music, and television. Studies have shown targeted alcohol marketing may result in the development of positive beliefs about drinking and expand environments where alcohol use is socially acceptable and encouraged.21 These factors can impact drinking behavior, including the onset of drinking, binge drinking, and increased alcohol consumption.22

Three VISN 21 sites in this study had restrictions on or excluded primary care from participation. Leadership at some of these facilities were concerned that primary care teams did not have the bandwidth to take on additional items and/or there was variable primary care readiness for initiating AUD pharmacotherapy. Further attempts should be made to integrate primary care into the process of initiating AUD treatment as significant research suggests that integrated care models for AUD may be associated with improved process and outcome measures of care.23

There are several differences between this quality improvement project and prior research investigating the impact of DTC education for other conditions, such as the EMPOWER randomized controlled trial and VISN 22 project, which both demonstrated effectiveness of DTC education for reducing benzodiazepine use in geriatric veterans. 15,16 These studies focused on reducing or stopping pharmacotherapy use, whereas this project sought to promote the initiation of AUD pharmacotherapy. These studies evaluated outcomes at least 6 months postindex date, whereas this project evaluated outcomes within 30 days postappointment. Furthermore, the educational content varied significantly. Other projects provided patients with information focused on specific medications and interventions, such as benzodiazepine tapering, while this project mailed general information on heavy drinking, its risks, and strategies for cutting back, without mentioning pharmacotherapy. The DTC material used in this project was chosen because it was a preapproved national VA ADS resource, which expedited the project timeline by avoiding the need for additional approvals at each participating site. These differences may impact the observed effectiveness of DTC education in this project, especially regarding the primary outcome.

Strengths and Limitations

This quality improvement project sent a large sample of veterans DTC education in a clinical setting across multiple sites. Additionally, PS matching methods were used to balance covariates between the comparator and DTC education group, thereby simulating a randomized controlled trial and reducing selection bias. The project brought attention to the VISN 21 AUD treatment rates, stimulated conversation across sites about available treatments and resources for AUD, and sparked collaboration between academic detailing, mental health, and primary care services. The time frame for visits was selected during the winter; the National Institute on Alcohol Abuse and Alcoholism notes this is a time when people may be more likely to engage in excessive alcohol consumption than at other times of the year.24

The 30-day time frame for outcomes may have been too short to observe changes in prescribing or referral patterns. Additionally, the comparator group was comprised of veterans seen from October 1, 2022, to January 31, 2023, where seasonal timing may have influenced alcohol consumption behaviors and skewed the results. There were also no-show appointments in the DTC education group (13.7%), though it is likely some patients rescheduled and still received AUD pharmacotherapy within 30 days of the original appointment. Finally, it was not possible to confirm whether a patient opened and read the education that was mailed to them. This may be another reason to explore electronic distribution of DTC education. This all may have contributed to the lack of statistically significant differences in both the primary and secondary outcomes.

There was a high level of variability between facility participation in the project. Two of 7 sites did not participate, and 3 sites restricted primary care engagement. This represents a significant limitation, particularly for the secondary outcome of placing consultations for MH or SUD services. Facilities that only included mental health or SUD HCPs may have resulted in lower consultation rates due to their inherent specialization, reducing the likelihood of self-referrals.

The project may overestimate prescribed AUD pharmacotherapy in the primary outcome due to potential misclassification of medications. While the project adhered to the national VA ADS AUD dashboard’s definition of AUD pharmacotherapy, including acamprosate, disulfiram, naltrexone, topiramate, and gabapentin, some of these medications have multiple indications. For example, gabapentin is commonly prescribed for peripheral neuropathy, and topiramate is used to treat migraines and seizures. The multipurpose use adds uncertainty about whether they were prescribed specifically for AUD treatment, especially in cases where the HCP is responsible for treating a broad range of disease states, as in primary care.

CONCLUSIONS

Results of this quality improvement project did not show a statistically significant difference between patients sent DTC education and the comparator group for the initiation of AUD pharmacotherapy or placement of a consult to mental health or SUD services within 30 days of their scheduled visit. Future studies may seek to implement stricter criteria to confirm the intended use of topiramate and gabapentin, such as looking for keywords in the prescription instructions for use, performing chart reviews, and/or only including these medications if prescribed by a mental health or SUD HCP. Alternatively, future studies may consider limiting the analysis to only FDA-approved AUD medications: acamprosate, disulfiram, and naltrexone. It is vital to continue to enhance primary care HCP readiness to treat AUD, given the existing relationships and trust they often have with patients. Electronic methods for distributing DTC education could also be advantageous, as these methods may have the ability to track whether a message has been opened and read. Despite a lack of statistical significance, this project sparked crucial conversations and collaboration around AUD, available treatments, and addressing potential barriers to connecting patients to care within VISN 21.

References
  1. Centers for Disease Control and Prevention. Facts about U.S. deaths from excessive alcohol use. August 6, 2024. Accessed February 5, 2025. https://www.cdc.gov/alcohol/facts-stats/
  2. State Health Access Data Assistance Center. Escalating alcohol-involved death rates: trends and variation across the nation and in the states from 2006 to 2019. April 19, 2021. Accessed February 5, 2025. https://www.shadac.org/escalating-alcohol-involved-death-rates-trends-and-variation-across-nation-and-states-2006-2019
  3. National Institute on Alcohol Abuse and Alcoholism. Alcohol- related emergencies and deaths in the United States. Updated November 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-related-emergencies-and-deaths-united-states
  4. Esser MB, Sherk A, Liu Y, Naimi TS. Deaths from excessive alcohol use - United States, 2016- 2021. MMWR Morb Mortal Wkly Rep. 2024;73(8):154-161. doi:10.15585/mmwr.mm7308a1
  5. Canver BR, Newman RK, Gomez AE. Alcohol Withdrawal Syndrome. In: StatPearls. StatPearls Publishing; 2024.
  6. National Institute on Alcohol Abuse and Alcoholism. Alcohol treatment in the United States. Updated January 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-treatment-united-states
  7. National Institute on Alcohol Abuse and Alcoholism. Alcohol use disorder (AUD) in the United States: age groups and demographic characteristics. Updated September 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-use-disorder-aud-united-states-age-groups-and-demographic-characteristics
  8. Reus VI, Fochtmann LJ, Bukstein O, et al. The American Psychiatric Association practice guideline for the pharmacological treatment of patients with alcohol use disorder. Am J Psychiatry. 2018;175(1):86-90. doi:10.1176/appi.ajp.2017.1750101
  9. Blodgett JC, Del Re AC, Maisel NC, Finney JW. A meta-analysis of topiramate’s effects for individuals with alcohol use disorders. Alcohol Clin Exp Res. 2014;38(6):1481-1488. doi:10.1111/acer.12411
  10. Maisel NC, Blodgett JC, Wilbourne PL, Humphreys K, Finney JW. Meta-analysis of naltrexone and acamprosate for treating alcohol use disorders: when are these medications most helpful? Addiction. 2013;108(2):275-293. doi:10.1111/j.1360-0443.2012.04054.x
  11. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014;311(18):1889-1900. doi:10.1001/jama.2014.3628
  12. US Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the management of substance use disorders. August 2021. Accessed February 5, 2025. https://www.healthquality.va.gov/guidelines/MH/sud/VADODSUDCPG.pdf
  13. Ranney RM, Bernhard PA, Vogt D, et al. Alcohol use and treatment utilization in a national sample of veterans and nonveterans. J Subst Use Addict Treat. 2023;146:208964. doi:10.1016/j.josat.2023.208964
  14. US Department of Veterans Affairs, Pharmacy Benefit Management Service, Academic Detailing Service. AUD Trend Report. https://vaww.pbi.cdw.va.gov/PBIRS/Pages/ReportViewer.aspx?/GPE/PBM_AD/SSRS/AUD/AUD_TrendReport
  15. Mendes MA, Smith JP, Marin JK, et al. Reducing benzodiazepine prescribing in older veterans: a direct-to-consumer educational brochure. Fed Pract. 2018;35(9):36-43.
  16. Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014;174(6):890-898. doi:10.1001/jamainternmed.2014.949
  17. Maloney R, Funmilayo M. Acting on the AUDIT-C: implementation of direct-to-consumer education on unhealth alcohol use. Presented on March 31, 2023; Central Virginia Veterans Affairs Health Care System, Richmond, Virginia.
  18. US Department of Veterans Affairs, Pharmacy Benefit Management Service. Alcohol use disorder (AUD) – leading the charge in the treatment of AUD: a VA clinician’s guide. February 2022. Accessed February 5, 2025. https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/508/10-1530_AUD_ClinicianGuide_508Conformant.pdf
  19. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46(3):399-424. doi:10.1080/00273171.2011.568786
  20. National Institute on Alcohol Abuse and Alcoholism. Stigma: overcoming a pervasive barrier to optimal care. Updated January 6, 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/health-professionals-communities/core-resource-on-alcohol/stigma-overcoming-pervasive-barrier-optimal-care
  21. Sudhinaraset M, Wigglesworth C, Takeuchi DT. Social and cultural contexts of alcohol use: influences in a socialecological framework. Alcohol Res. 2016;38(1):35-45.
  22. Tanski SE, McClure AC, Li Z, et al. Cued recall of alcohol advertising on television and underage drinking behavior. JAMA Pediatr. 2015;169(3):264-271. doi:10.1001/jamapediatrics.2014.3345
  23. Hyland CJ, McDowell MJ, Bain PA, Huskamp HA, Busch AB. Integration of pharmacotherapy for alcohol use disorder treatment in primary care settings: a scoping review. J Subst Abuse Treat. 2023;144:108919. doi:10.1016/j.jsat.2022.108919
  24. National Institute on Alcohol Abuse and Alcoholism. The truth about holiday spirits. Updated November 2023. Accessed February 5, 2025. ,a href="https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits">https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits
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Correspondence: Julie Beauchamp (julie.beauchamp@ va.gov)

Fed Pract. 2025;42(5). Published online May 17. doi:10.12788/fp.0562

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Author affiliations 
aVA Sierra Pacific Network (VISN 21)

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The authors report no actual or potential conflicts of interest in regard to this article.

Correspondence: Julie Beauchamp (julie.beauchamp@ va.gov)

Fed Pract. 2025;42(5). Published online May 17. doi:10.12788/fp.0562

Author and Disclosure Information

Julie R. Beauchamp, PharmDa; Robert Malmstrom, PharmDa; Ramona Shayegani, PharmDa; Steve T. Flynn, PharmD, BCPSa; Amy E. Robinson, PharmDa; Jennifer R. Marin, PharmD, BCPSa; David B. Huberman, PhDa; Janice M. Taylor, PharmD, BCPSa; Scott E. Mambourg, PharmD, BCPSa

Author affiliations 
aVA Sierra Pacific Network (VISN 21)

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The authors report no actual or potential conflicts of interest in regard to this article.

Correspondence: Julie Beauchamp (julie.beauchamp@ va.gov)

Fed Pract. 2025;42(5). Published online May 17. doi:10.12788/fp.0562

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Excessive alcohol use is one of the leading preventable causes of death in the United States, responsible for about 178,000 deaths annually and an average of 488 daily deaths in 2020 and 2021.1Alcohol-related deaths increased by 49% between 2006 and 2019.2 This trend continued during the COVID-19 pandemic, with death certificates that listed alcohol increasing by > 25% from 2019 to 2020, and another 10% in 2021.3 This increase of alcohol-related deaths includes those as a direct result of chronic alcohol use, such as alcoholic cardiomyopathy, alcoholic hepatitis and cirrhosis, and alcohol-induced pancreatitis, as well as a result of acute use such as alcohol poisoning, suicide by exposure to alcohol, and alcohol-impaired driving fatalities.4

Excessive alcohol consumption poses other serious risks, including cases when intake is abruptly reduced without proper management. Alcohol withdrawal syndrome (AWS) can vary in severity, with potentially life-threatening complications such as hallucinations, seizures, and delirium tremens.5

These risks highlight the importance of professional intervention and support, not only to mitigate risks associated with AWS, but provide a pathway towards recovery from alcohol use disorder (AUD).

According to the 2022 National Survey on Drug Use and Health, 28.8 million US adults had AUD in the prior year, yet only 7.6% of these individuals received treatment and an even smaller group (2.2%) received medication-assisted treatment for alcohol.6,7 This is despite American Psychiatric Association guidelines for the pharmacological treatment of patients with AUD, including the use of naltrexone, acamprosate, disulfiram, topiramate, or gabapentin, depending on therapy goals, past medication trials, medication contraindications, and patient preference.8 Several of these medications are approved by the US Food and Drug Administration (FDA) for the treatment of AUD and have support for effectiveness from randomized controlled trials and meta-analyses.9-11

Clinical practice guidelines for the management of substance use disorders (SUDs) from the US Department of Veterans Affairs (VA) and US Department of Defense have strong recommendations for naltrexone and topiramate as first-line pharmacotherapies for moderate to severe AUD. Acamprosate and disulfiram are weak recommendations as alternative options. Gabapentin is a weak recommendation for cases where first-line treatments are contraindicated or ineffective. The guidelines emphasize the importance of a comprehensive approach to AUD treatment, including psychosocial interventions in addition to pharmacotherapy.12

A 2023 national survey found veterans reported higher alcohol consumption than nonveterans.13 At the end of fiscal year 2023, > 4.4 million veterans—6% of Veterans Health Administration patients—had been diagnosed with AUD.14 However, > 87% of these patients nationally, and 88% of Veterans Integrated Service Network (VISN) 21 patients, were not receiving naltrexone, acamprosate, disulfiram, or topiramate as part of their treatment. The VA Academic Detailing Service (ADS) now includes AUD pharmacotherapy as a campaign focus, highlighting its importance. The ADS is a pharmacy educational outreach program that uses unbiased clinical guidelines to promote aligning prescribing behavior with best practices. Academic detailing methods include speaking with health care practitioners (HCPs), and direct-to-consumer (DTC) patient education.

ADS campaigns include DTC educational handouts. Past ADS projects and research using DTC have demonstrated a significant improvement in outcomes and positively influencing patients’ pharmacotherapy treatment. 15,16 A VA quality improvement project found a positive correlation between the initiation of AUD pharmacotherapy and engagement with mental health care following the distribution of AUD DTC patient education. 17 This project aimed to apply the same principles of prior research to explore the use of DTC across multiple facilities within VISN 21 to increase AUD pharmacotherapy. VISN 21 includes VA facilities and clinics across the Pacific Islands, Nevada, and California and serves about 350,000 veterans.

METHODS

A prospective cohort of VISN 21 veterans with or at high risk for AUD was identified using the VA ADS AUD Dashboard. The cohort included those not on acamprosate, disulfiram, naltrexone, topiramate, or gabapentin for treatment of AUD and had an elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score of ≥ 6 (high risk) with an AUD diagnosis or ≥ 8 (severe risk) without a diagnosis. The AUDIT-C scores used in the dashboard are supported by the VA AUD clinician guide as the minimum scores when AUD pharmacotherapy should be offered to patients.18 Prescriptions filled outside the VA were not included in this dashboard.

Data and patient information were collected using the VA Corporate Data Warehouse. To be eligible, veterans needed a valid mailing address within the VISN 21 region and a primary care, mental health, or SUD clinician prescriber visit scheduled between October 1, 2023, and January 31, 2024. Veterans were excluded if they were in hospice, had a 1-year mortality risk score > 50% based on their Care Assessment Need (CAN) score, or facility leadership opted out of project involvement. Patients with both severe renal and hepatic impairments were excluded because they were ineligible for AUD pharmacotherapy. However, veterans with either renal or hepatic impairment (but not both) were included, as they could be potential candidates for ≥ 1 AUD pharmacotherapy option.

Initial correspondence with facilities was initiated through local academic detailers. A local champion was identified for the 1 facility without an academic detailer. Facilities could opt in or out of the project. Approval was provided by the local pharmacy and therapeutics committee, pharmacy, primary care, or psychiatry leadership. Approval process and clinician involvement varied by site.

Education

The selected AUD patient education was designed and approved by the national VA ADS (eappendix). The DTC patient education provided general knowledge about alcohol, including what constitutes a standard amount of alcohol, what is considered heavy drinking, risks of heavy drinking, creating a plan with a clinician to reduce and manage withdrawal symptoms, and additional resources. The DTC was accompanied by a cover letter that included a local facility contact number.

A centralized mailing facility was used for all materials. VA Northern California Health Care System provided the funding to cover the cost of postage. The list of veterans to be contacted was updated on a rolling basis and DTC education was mailed 2 weeks prior to their scheduled prescriber visit.

The eligible cohort of 1260 veterans received DTC education. A comparator group of 2048 veterans that did not receive DTC education was obtained retrospectively by using the same inclusion and exclusion criteria with a scheduled primary care, mental health, or SUD HCP visit from October 1, 2022, to January 31, 2023. The outcomes assessed were within 30 days of the scheduled visit, with the primary outcome as the initiation of AUD-related pharmacotherapy and the secondary outcome as the placement of a consultation for mental health or SUD services. Any consultations sent to Behavioral Health, Addiction, Mental Health, Psychiatric, and SUD services following the HCP visit, within the specified time frame, were used for the secondary outcome.

Matching and Analysis

A 1-to-1 nearest neighbor propensity score (PS) matching without replacement was used to pair the 1260 veterans from the intervention group with similarly scored comparator group veterans for a PS-matched final dataset of 2520 veterans. The PS model was a multivariate logistic regression with the outcome being exposure and comparator group status. Baseline characteristics used in the PS model were age, birth sex, race, facility of care, baseline AUDIT-C score, and days between project start and scheduled appointment. Covariate imbalance for the PS-matched sample was assessed to ensure the standardized mean difference for all covariates fell under a 0.1 threshold (Figure).19

0525FED-eAUD-F1

A frequency table was provided to compare the discrete distributions of the baseline characteristics in the intervention and comparator groups. Logistic regression analysis was performed to evaluate the association between DTC education exposure and pharmacotherapy initiation, while controlling for potential confounders. Univariate and multivariate P value results for each variable included in the model were reported along with the multivariate odds ratios (ORs) and their associated 95% CIs. Logistic regression analyses were run for both outcomes. Each model included the exposure and comparator group status as well as the baseline characteristics included in the PS model. Statistical significance was set at P < .05. All statistical analyses were performed with R version 4.2.1.

RESULTS

Two of 7 VISN 21 sites did not participate, and 3 had restrictions on participation. DTC education was mailed about 2 weeks prior to scheduled visit for 1260 veterans; 53.6% identified as White, 37.6% were aged 41 to 60 years, and 79.2% had an AUDIT-C ≥ 8 (Table 1). Of those mailed education, there were 173 no-show appointments (13.7%). Thirty-two veterans (2.5%) in the DTC group and 33 veterans (2.6%) in the comparator group received an AUD-related pharmacotherapy prescription (P = .88) (Table 2). One hundred seventy-one veterans (13.6%) in the DTC group and 160 veterans (12.7%) in the comparator group had a consult placed for mental health or SUD services within 30 days of their appointment (P = .59) (Table 3).

0525FED-eAUD-T10525FED-eAUD-T20525FED-eAUD-T3

DISCUSSION

This project did not yield statistically significant differences in either the primary or secondary outcomes within the 30-day follow-up window and found limited impact from the DTC educational outreach to veterans. The percentage of veterans that received AUD-related pharmacotherapy or consultations for mental health or SUD services was similarly low in the DTC and comparator groups. These findings suggest that although DTC education may raise awareness, it may not be sufficient on its own to drive changes in prescribing behavior or referral patterns without system-level support.

Addiction is a complex disease faced with stigma and requiring readiness by both the HCP and patient to move forward in support and treatment. The consequences of stigma can be severe: the more stigma perceived by a person with AUD, the less likely they are to seek treatment.20 Stigma may exist even within HCPs and may lead to compromised care including shortened visits, less engagement, and less empathy.19 Cultural attitude towards alcohol use and intoxication can also be influenced through a wide range of sources including social media, movies, music, and television. Studies have shown targeted alcohol marketing may result in the development of positive beliefs about drinking and expand environments where alcohol use is socially acceptable and encouraged.21 These factors can impact drinking behavior, including the onset of drinking, binge drinking, and increased alcohol consumption.22

Three VISN 21 sites in this study had restrictions on or excluded primary care from participation. Leadership at some of these facilities were concerned that primary care teams did not have the bandwidth to take on additional items and/or there was variable primary care readiness for initiating AUD pharmacotherapy. Further attempts should be made to integrate primary care into the process of initiating AUD treatment as significant research suggests that integrated care models for AUD may be associated with improved process and outcome measures of care.23

There are several differences between this quality improvement project and prior research investigating the impact of DTC education for other conditions, such as the EMPOWER randomized controlled trial and VISN 22 project, which both demonstrated effectiveness of DTC education for reducing benzodiazepine use in geriatric veterans. 15,16 These studies focused on reducing or stopping pharmacotherapy use, whereas this project sought to promote the initiation of AUD pharmacotherapy. These studies evaluated outcomes at least 6 months postindex date, whereas this project evaluated outcomes within 30 days postappointment. Furthermore, the educational content varied significantly. Other projects provided patients with information focused on specific medications and interventions, such as benzodiazepine tapering, while this project mailed general information on heavy drinking, its risks, and strategies for cutting back, without mentioning pharmacotherapy. The DTC material used in this project was chosen because it was a preapproved national VA ADS resource, which expedited the project timeline by avoiding the need for additional approvals at each participating site. These differences may impact the observed effectiveness of DTC education in this project, especially regarding the primary outcome.

Strengths and Limitations

This quality improvement project sent a large sample of veterans DTC education in a clinical setting across multiple sites. Additionally, PS matching methods were used to balance covariates between the comparator and DTC education group, thereby simulating a randomized controlled trial and reducing selection bias. The project brought attention to the VISN 21 AUD treatment rates, stimulated conversation across sites about available treatments and resources for AUD, and sparked collaboration between academic detailing, mental health, and primary care services. The time frame for visits was selected during the winter; the National Institute on Alcohol Abuse and Alcoholism notes this is a time when people may be more likely to engage in excessive alcohol consumption than at other times of the year.24

The 30-day time frame for outcomes may have been too short to observe changes in prescribing or referral patterns. Additionally, the comparator group was comprised of veterans seen from October 1, 2022, to January 31, 2023, where seasonal timing may have influenced alcohol consumption behaviors and skewed the results. There were also no-show appointments in the DTC education group (13.7%), though it is likely some patients rescheduled and still received AUD pharmacotherapy within 30 days of the original appointment. Finally, it was not possible to confirm whether a patient opened and read the education that was mailed to them. This may be another reason to explore electronic distribution of DTC education. This all may have contributed to the lack of statistically significant differences in both the primary and secondary outcomes.

There was a high level of variability between facility participation in the project. Two of 7 sites did not participate, and 3 sites restricted primary care engagement. This represents a significant limitation, particularly for the secondary outcome of placing consultations for MH or SUD services. Facilities that only included mental health or SUD HCPs may have resulted in lower consultation rates due to their inherent specialization, reducing the likelihood of self-referrals.

The project may overestimate prescribed AUD pharmacotherapy in the primary outcome due to potential misclassification of medications. While the project adhered to the national VA ADS AUD dashboard’s definition of AUD pharmacotherapy, including acamprosate, disulfiram, naltrexone, topiramate, and gabapentin, some of these medications have multiple indications. For example, gabapentin is commonly prescribed for peripheral neuropathy, and topiramate is used to treat migraines and seizures. The multipurpose use adds uncertainty about whether they were prescribed specifically for AUD treatment, especially in cases where the HCP is responsible for treating a broad range of disease states, as in primary care.

CONCLUSIONS

Results of this quality improvement project did not show a statistically significant difference between patients sent DTC education and the comparator group for the initiation of AUD pharmacotherapy or placement of a consult to mental health or SUD services within 30 days of their scheduled visit. Future studies may seek to implement stricter criteria to confirm the intended use of topiramate and gabapentin, such as looking for keywords in the prescription instructions for use, performing chart reviews, and/or only including these medications if prescribed by a mental health or SUD HCP. Alternatively, future studies may consider limiting the analysis to only FDA-approved AUD medications: acamprosate, disulfiram, and naltrexone. It is vital to continue to enhance primary care HCP readiness to treat AUD, given the existing relationships and trust they often have with patients. Electronic methods for distributing DTC education could also be advantageous, as these methods may have the ability to track whether a message has been opened and read. Despite a lack of statistical significance, this project sparked crucial conversations and collaboration around AUD, available treatments, and addressing potential barriers to connecting patients to care within VISN 21.

Excessive alcohol use is one of the leading preventable causes of death in the United States, responsible for about 178,000 deaths annually and an average of 488 daily deaths in 2020 and 2021.1Alcohol-related deaths increased by 49% between 2006 and 2019.2 This trend continued during the COVID-19 pandemic, with death certificates that listed alcohol increasing by > 25% from 2019 to 2020, and another 10% in 2021.3 This increase of alcohol-related deaths includes those as a direct result of chronic alcohol use, such as alcoholic cardiomyopathy, alcoholic hepatitis and cirrhosis, and alcohol-induced pancreatitis, as well as a result of acute use such as alcohol poisoning, suicide by exposure to alcohol, and alcohol-impaired driving fatalities.4

Excessive alcohol consumption poses other serious risks, including cases when intake is abruptly reduced without proper management. Alcohol withdrawal syndrome (AWS) can vary in severity, with potentially life-threatening complications such as hallucinations, seizures, and delirium tremens.5

These risks highlight the importance of professional intervention and support, not only to mitigate risks associated with AWS, but provide a pathway towards recovery from alcohol use disorder (AUD).

According to the 2022 National Survey on Drug Use and Health, 28.8 million US adults had AUD in the prior year, yet only 7.6% of these individuals received treatment and an even smaller group (2.2%) received medication-assisted treatment for alcohol.6,7 This is despite American Psychiatric Association guidelines for the pharmacological treatment of patients with AUD, including the use of naltrexone, acamprosate, disulfiram, topiramate, or gabapentin, depending on therapy goals, past medication trials, medication contraindications, and patient preference.8 Several of these medications are approved by the US Food and Drug Administration (FDA) for the treatment of AUD and have support for effectiveness from randomized controlled trials and meta-analyses.9-11

Clinical practice guidelines for the management of substance use disorders (SUDs) from the US Department of Veterans Affairs (VA) and US Department of Defense have strong recommendations for naltrexone and topiramate as first-line pharmacotherapies for moderate to severe AUD. Acamprosate and disulfiram are weak recommendations as alternative options. Gabapentin is a weak recommendation for cases where first-line treatments are contraindicated or ineffective. The guidelines emphasize the importance of a comprehensive approach to AUD treatment, including psychosocial interventions in addition to pharmacotherapy.12

A 2023 national survey found veterans reported higher alcohol consumption than nonveterans.13 At the end of fiscal year 2023, > 4.4 million veterans—6% of Veterans Health Administration patients—had been diagnosed with AUD.14 However, > 87% of these patients nationally, and 88% of Veterans Integrated Service Network (VISN) 21 patients, were not receiving naltrexone, acamprosate, disulfiram, or topiramate as part of their treatment. The VA Academic Detailing Service (ADS) now includes AUD pharmacotherapy as a campaign focus, highlighting its importance. The ADS is a pharmacy educational outreach program that uses unbiased clinical guidelines to promote aligning prescribing behavior with best practices. Academic detailing methods include speaking with health care practitioners (HCPs), and direct-to-consumer (DTC) patient education.

ADS campaigns include DTC educational handouts. Past ADS projects and research using DTC have demonstrated a significant improvement in outcomes and positively influencing patients’ pharmacotherapy treatment. 15,16 A VA quality improvement project found a positive correlation between the initiation of AUD pharmacotherapy and engagement with mental health care following the distribution of AUD DTC patient education. 17 This project aimed to apply the same principles of prior research to explore the use of DTC across multiple facilities within VISN 21 to increase AUD pharmacotherapy. VISN 21 includes VA facilities and clinics across the Pacific Islands, Nevada, and California and serves about 350,000 veterans.

METHODS

A prospective cohort of VISN 21 veterans with or at high risk for AUD was identified using the VA ADS AUD Dashboard. The cohort included those not on acamprosate, disulfiram, naltrexone, topiramate, or gabapentin for treatment of AUD and had an elevated Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score of ≥ 6 (high risk) with an AUD diagnosis or ≥ 8 (severe risk) without a diagnosis. The AUDIT-C scores used in the dashboard are supported by the VA AUD clinician guide as the minimum scores when AUD pharmacotherapy should be offered to patients.18 Prescriptions filled outside the VA were not included in this dashboard.

Data and patient information were collected using the VA Corporate Data Warehouse. To be eligible, veterans needed a valid mailing address within the VISN 21 region and a primary care, mental health, or SUD clinician prescriber visit scheduled between October 1, 2023, and January 31, 2024. Veterans were excluded if they were in hospice, had a 1-year mortality risk score > 50% based on their Care Assessment Need (CAN) score, or facility leadership opted out of project involvement. Patients with both severe renal and hepatic impairments were excluded because they were ineligible for AUD pharmacotherapy. However, veterans with either renal or hepatic impairment (but not both) were included, as they could be potential candidates for ≥ 1 AUD pharmacotherapy option.

Initial correspondence with facilities was initiated through local academic detailers. A local champion was identified for the 1 facility without an academic detailer. Facilities could opt in or out of the project. Approval was provided by the local pharmacy and therapeutics committee, pharmacy, primary care, or psychiatry leadership. Approval process and clinician involvement varied by site.

Education

The selected AUD patient education was designed and approved by the national VA ADS (eappendix). The DTC patient education provided general knowledge about alcohol, including what constitutes a standard amount of alcohol, what is considered heavy drinking, risks of heavy drinking, creating a plan with a clinician to reduce and manage withdrawal symptoms, and additional resources. The DTC was accompanied by a cover letter that included a local facility contact number.

A centralized mailing facility was used for all materials. VA Northern California Health Care System provided the funding to cover the cost of postage. The list of veterans to be contacted was updated on a rolling basis and DTC education was mailed 2 weeks prior to their scheduled prescriber visit.

The eligible cohort of 1260 veterans received DTC education. A comparator group of 2048 veterans that did not receive DTC education was obtained retrospectively by using the same inclusion and exclusion criteria with a scheduled primary care, mental health, or SUD HCP visit from October 1, 2022, to January 31, 2023. The outcomes assessed were within 30 days of the scheduled visit, with the primary outcome as the initiation of AUD-related pharmacotherapy and the secondary outcome as the placement of a consultation for mental health or SUD services. Any consultations sent to Behavioral Health, Addiction, Mental Health, Psychiatric, and SUD services following the HCP visit, within the specified time frame, were used for the secondary outcome.

Matching and Analysis

A 1-to-1 nearest neighbor propensity score (PS) matching without replacement was used to pair the 1260 veterans from the intervention group with similarly scored comparator group veterans for a PS-matched final dataset of 2520 veterans. The PS model was a multivariate logistic regression with the outcome being exposure and comparator group status. Baseline characteristics used in the PS model were age, birth sex, race, facility of care, baseline AUDIT-C score, and days between project start and scheduled appointment. Covariate imbalance for the PS-matched sample was assessed to ensure the standardized mean difference for all covariates fell under a 0.1 threshold (Figure).19

0525FED-eAUD-F1

A frequency table was provided to compare the discrete distributions of the baseline characteristics in the intervention and comparator groups. Logistic regression analysis was performed to evaluate the association between DTC education exposure and pharmacotherapy initiation, while controlling for potential confounders. Univariate and multivariate P value results for each variable included in the model were reported along with the multivariate odds ratios (ORs) and their associated 95% CIs. Logistic regression analyses were run for both outcomes. Each model included the exposure and comparator group status as well as the baseline characteristics included in the PS model. Statistical significance was set at P < .05. All statistical analyses were performed with R version 4.2.1.

RESULTS

Two of 7 VISN 21 sites did not participate, and 3 had restrictions on participation. DTC education was mailed about 2 weeks prior to scheduled visit for 1260 veterans; 53.6% identified as White, 37.6% were aged 41 to 60 years, and 79.2% had an AUDIT-C ≥ 8 (Table 1). Of those mailed education, there were 173 no-show appointments (13.7%). Thirty-two veterans (2.5%) in the DTC group and 33 veterans (2.6%) in the comparator group received an AUD-related pharmacotherapy prescription (P = .88) (Table 2). One hundred seventy-one veterans (13.6%) in the DTC group and 160 veterans (12.7%) in the comparator group had a consult placed for mental health or SUD services within 30 days of their appointment (P = .59) (Table 3).

0525FED-eAUD-T10525FED-eAUD-T20525FED-eAUD-T3

DISCUSSION

This project did not yield statistically significant differences in either the primary or secondary outcomes within the 30-day follow-up window and found limited impact from the DTC educational outreach to veterans. The percentage of veterans that received AUD-related pharmacotherapy or consultations for mental health or SUD services was similarly low in the DTC and comparator groups. These findings suggest that although DTC education may raise awareness, it may not be sufficient on its own to drive changes in prescribing behavior or referral patterns without system-level support.

Addiction is a complex disease faced with stigma and requiring readiness by both the HCP and patient to move forward in support and treatment. The consequences of stigma can be severe: the more stigma perceived by a person with AUD, the less likely they are to seek treatment.20 Stigma may exist even within HCPs and may lead to compromised care including shortened visits, less engagement, and less empathy.19 Cultural attitude towards alcohol use and intoxication can also be influenced through a wide range of sources including social media, movies, music, and television. Studies have shown targeted alcohol marketing may result in the development of positive beliefs about drinking and expand environments where alcohol use is socially acceptable and encouraged.21 These factors can impact drinking behavior, including the onset of drinking, binge drinking, and increased alcohol consumption.22

Three VISN 21 sites in this study had restrictions on or excluded primary care from participation. Leadership at some of these facilities were concerned that primary care teams did not have the bandwidth to take on additional items and/or there was variable primary care readiness for initiating AUD pharmacotherapy. Further attempts should be made to integrate primary care into the process of initiating AUD treatment as significant research suggests that integrated care models for AUD may be associated with improved process and outcome measures of care.23

There are several differences between this quality improvement project and prior research investigating the impact of DTC education for other conditions, such as the EMPOWER randomized controlled trial and VISN 22 project, which both demonstrated effectiveness of DTC education for reducing benzodiazepine use in geriatric veterans. 15,16 These studies focused on reducing or stopping pharmacotherapy use, whereas this project sought to promote the initiation of AUD pharmacotherapy. These studies evaluated outcomes at least 6 months postindex date, whereas this project evaluated outcomes within 30 days postappointment. Furthermore, the educational content varied significantly. Other projects provided patients with information focused on specific medications and interventions, such as benzodiazepine tapering, while this project mailed general information on heavy drinking, its risks, and strategies for cutting back, without mentioning pharmacotherapy. The DTC material used in this project was chosen because it was a preapproved national VA ADS resource, which expedited the project timeline by avoiding the need for additional approvals at each participating site. These differences may impact the observed effectiveness of DTC education in this project, especially regarding the primary outcome.

Strengths and Limitations

This quality improvement project sent a large sample of veterans DTC education in a clinical setting across multiple sites. Additionally, PS matching methods were used to balance covariates between the comparator and DTC education group, thereby simulating a randomized controlled trial and reducing selection bias. The project brought attention to the VISN 21 AUD treatment rates, stimulated conversation across sites about available treatments and resources for AUD, and sparked collaboration between academic detailing, mental health, and primary care services. The time frame for visits was selected during the winter; the National Institute on Alcohol Abuse and Alcoholism notes this is a time when people may be more likely to engage in excessive alcohol consumption than at other times of the year.24

The 30-day time frame for outcomes may have been too short to observe changes in prescribing or referral patterns. Additionally, the comparator group was comprised of veterans seen from October 1, 2022, to January 31, 2023, where seasonal timing may have influenced alcohol consumption behaviors and skewed the results. There were also no-show appointments in the DTC education group (13.7%), though it is likely some patients rescheduled and still received AUD pharmacotherapy within 30 days of the original appointment. Finally, it was not possible to confirm whether a patient opened and read the education that was mailed to them. This may be another reason to explore electronic distribution of DTC education. This all may have contributed to the lack of statistically significant differences in both the primary and secondary outcomes.

There was a high level of variability between facility participation in the project. Two of 7 sites did not participate, and 3 sites restricted primary care engagement. This represents a significant limitation, particularly for the secondary outcome of placing consultations for MH or SUD services. Facilities that only included mental health or SUD HCPs may have resulted in lower consultation rates due to their inherent specialization, reducing the likelihood of self-referrals.

The project may overestimate prescribed AUD pharmacotherapy in the primary outcome due to potential misclassification of medications. While the project adhered to the national VA ADS AUD dashboard’s definition of AUD pharmacotherapy, including acamprosate, disulfiram, naltrexone, topiramate, and gabapentin, some of these medications have multiple indications. For example, gabapentin is commonly prescribed for peripheral neuropathy, and topiramate is used to treat migraines and seizures. The multipurpose use adds uncertainty about whether they were prescribed specifically for AUD treatment, especially in cases where the HCP is responsible for treating a broad range of disease states, as in primary care.

CONCLUSIONS

Results of this quality improvement project did not show a statistically significant difference between patients sent DTC education and the comparator group for the initiation of AUD pharmacotherapy or placement of a consult to mental health or SUD services within 30 days of their scheduled visit. Future studies may seek to implement stricter criteria to confirm the intended use of topiramate and gabapentin, such as looking for keywords in the prescription instructions for use, performing chart reviews, and/or only including these medications if prescribed by a mental health or SUD HCP. Alternatively, future studies may consider limiting the analysis to only FDA-approved AUD medications: acamprosate, disulfiram, and naltrexone. It is vital to continue to enhance primary care HCP readiness to treat AUD, given the existing relationships and trust they often have with patients. Electronic methods for distributing DTC education could also be advantageous, as these methods may have the ability to track whether a message has been opened and read. Despite a lack of statistical significance, this project sparked crucial conversations and collaboration around AUD, available treatments, and addressing potential barriers to connecting patients to care within VISN 21.

References
  1. Centers for Disease Control and Prevention. Facts about U.S. deaths from excessive alcohol use. August 6, 2024. Accessed February 5, 2025. https://www.cdc.gov/alcohol/facts-stats/
  2. State Health Access Data Assistance Center. Escalating alcohol-involved death rates: trends and variation across the nation and in the states from 2006 to 2019. April 19, 2021. Accessed February 5, 2025. https://www.shadac.org/escalating-alcohol-involved-death-rates-trends-and-variation-across-nation-and-states-2006-2019
  3. National Institute on Alcohol Abuse and Alcoholism. Alcohol- related emergencies and deaths in the United States. Updated November 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-related-emergencies-and-deaths-united-states
  4. Esser MB, Sherk A, Liu Y, Naimi TS. Deaths from excessive alcohol use - United States, 2016- 2021. MMWR Morb Mortal Wkly Rep. 2024;73(8):154-161. doi:10.15585/mmwr.mm7308a1
  5. Canver BR, Newman RK, Gomez AE. Alcohol Withdrawal Syndrome. In: StatPearls. StatPearls Publishing; 2024.
  6. National Institute on Alcohol Abuse and Alcoholism. Alcohol treatment in the United States. Updated January 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-treatment-united-states
  7. National Institute on Alcohol Abuse and Alcoholism. Alcohol use disorder (AUD) in the United States: age groups and demographic characteristics. Updated September 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-use-disorder-aud-united-states-age-groups-and-demographic-characteristics
  8. Reus VI, Fochtmann LJ, Bukstein O, et al. The American Psychiatric Association practice guideline for the pharmacological treatment of patients with alcohol use disorder. Am J Psychiatry. 2018;175(1):86-90. doi:10.1176/appi.ajp.2017.1750101
  9. Blodgett JC, Del Re AC, Maisel NC, Finney JW. A meta-analysis of topiramate’s effects for individuals with alcohol use disorders. Alcohol Clin Exp Res. 2014;38(6):1481-1488. doi:10.1111/acer.12411
  10. Maisel NC, Blodgett JC, Wilbourne PL, Humphreys K, Finney JW. Meta-analysis of naltrexone and acamprosate for treating alcohol use disorders: when are these medications most helpful? Addiction. 2013;108(2):275-293. doi:10.1111/j.1360-0443.2012.04054.x
  11. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014;311(18):1889-1900. doi:10.1001/jama.2014.3628
  12. US Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the management of substance use disorders. August 2021. Accessed February 5, 2025. https://www.healthquality.va.gov/guidelines/MH/sud/VADODSUDCPG.pdf
  13. Ranney RM, Bernhard PA, Vogt D, et al. Alcohol use and treatment utilization in a national sample of veterans and nonveterans. J Subst Use Addict Treat. 2023;146:208964. doi:10.1016/j.josat.2023.208964
  14. US Department of Veterans Affairs, Pharmacy Benefit Management Service, Academic Detailing Service. AUD Trend Report. https://vaww.pbi.cdw.va.gov/PBIRS/Pages/ReportViewer.aspx?/GPE/PBM_AD/SSRS/AUD/AUD_TrendReport
  15. Mendes MA, Smith JP, Marin JK, et al. Reducing benzodiazepine prescribing in older veterans: a direct-to-consumer educational brochure. Fed Pract. 2018;35(9):36-43.
  16. Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014;174(6):890-898. doi:10.1001/jamainternmed.2014.949
  17. Maloney R, Funmilayo M. Acting on the AUDIT-C: implementation of direct-to-consumer education on unhealth alcohol use. Presented on March 31, 2023; Central Virginia Veterans Affairs Health Care System, Richmond, Virginia.
  18. US Department of Veterans Affairs, Pharmacy Benefit Management Service. Alcohol use disorder (AUD) – leading the charge in the treatment of AUD: a VA clinician’s guide. February 2022. Accessed February 5, 2025. https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/508/10-1530_AUD_ClinicianGuide_508Conformant.pdf
  19. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46(3):399-424. doi:10.1080/00273171.2011.568786
  20. National Institute on Alcohol Abuse and Alcoholism. Stigma: overcoming a pervasive barrier to optimal care. Updated January 6, 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/health-professionals-communities/core-resource-on-alcohol/stigma-overcoming-pervasive-barrier-optimal-care
  21. Sudhinaraset M, Wigglesworth C, Takeuchi DT. Social and cultural contexts of alcohol use: influences in a socialecological framework. Alcohol Res. 2016;38(1):35-45.
  22. Tanski SE, McClure AC, Li Z, et al. Cued recall of alcohol advertising on television and underage drinking behavior. JAMA Pediatr. 2015;169(3):264-271. doi:10.1001/jamapediatrics.2014.3345
  23. Hyland CJ, McDowell MJ, Bain PA, Huskamp HA, Busch AB. Integration of pharmacotherapy for alcohol use disorder treatment in primary care settings: a scoping review. J Subst Abuse Treat. 2023;144:108919. doi:10.1016/j.jsat.2022.108919
  24. National Institute on Alcohol Abuse and Alcoholism. The truth about holiday spirits. Updated November 2023. Accessed February 5, 2025. ,a href="https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits">https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits
References
  1. Centers for Disease Control and Prevention. Facts about U.S. deaths from excessive alcohol use. August 6, 2024. Accessed February 5, 2025. https://www.cdc.gov/alcohol/facts-stats/
  2. State Health Access Data Assistance Center. Escalating alcohol-involved death rates: trends and variation across the nation and in the states from 2006 to 2019. April 19, 2021. Accessed February 5, 2025. https://www.shadac.org/escalating-alcohol-involved-death-rates-trends-and-variation-across-nation-and-states-2006-2019
  3. National Institute on Alcohol Abuse and Alcoholism. Alcohol- related emergencies and deaths in the United States. Updated November 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-related-emergencies-and-deaths-united-states
  4. Esser MB, Sherk A, Liu Y, Naimi TS. Deaths from excessive alcohol use - United States, 2016- 2021. MMWR Morb Mortal Wkly Rep. 2024;73(8):154-161. doi:10.15585/mmwr.mm7308a1
  5. Canver BR, Newman RK, Gomez AE. Alcohol Withdrawal Syndrome. In: StatPearls. StatPearls Publishing; 2024.
  6. National Institute on Alcohol Abuse and Alcoholism. Alcohol treatment in the United States. Updated January 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-treatment-united-states
  7. National Institute on Alcohol Abuse and Alcoholism. Alcohol use disorder (AUD) in the United States: age groups and demographic characteristics. Updated September 2024. Accessed February 5, 2025. https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-use-disorder-aud-united-states-age-groups-and-demographic-characteristics
  8. Reus VI, Fochtmann LJ, Bukstein O, et al. The American Psychiatric Association practice guideline for the pharmacological treatment of patients with alcohol use disorder. Am J Psychiatry. 2018;175(1):86-90. doi:10.1176/appi.ajp.2017.1750101
  9. Blodgett JC, Del Re AC, Maisel NC, Finney JW. A meta-analysis of topiramate’s effects for individuals with alcohol use disorders. Alcohol Clin Exp Res. 2014;38(6):1481-1488. doi:10.1111/acer.12411
  10. Maisel NC, Blodgett JC, Wilbourne PL, Humphreys K, Finney JW. Meta-analysis of naltrexone and acamprosate for treating alcohol use disorders: when are these medications most helpful? Addiction. 2013;108(2):275-293. doi:10.1111/j.1360-0443.2012.04054.x
  11. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014;311(18):1889-1900. doi:10.1001/jama.2014.3628
  12. US Department of Veterans Affairs, Department of Defense. VA/DoD clinical practice guideline for the management of substance use disorders. August 2021. Accessed February 5, 2025. https://www.healthquality.va.gov/guidelines/MH/sud/VADODSUDCPG.pdf
  13. Ranney RM, Bernhard PA, Vogt D, et al. Alcohol use and treatment utilization in a national sample of veterans and nonveterans. J Subst Use Addict Treat. 2023;146:208964. doi:10.1016/j.josat.2023.208964
  14. US Department of Veterans Affairs, Pharmacy Benefit Management Service, Academic Detailing Service. AUD Trend Report. https://vaww.pbi.cdw.va.gov/PBIRS/Pages/ReportViewer.aspx?/GPE/PBM_AD/SSRS/AUD/AUD_TrendReport
  15. Mendes MA, Smith JP, Marin JK, et al. Reducing benzodiazepine prescribing in older veterans: a direct-to-consumer educational brochure. Fed Pract. 2018;35(9):36-43.
  16. Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014;174(6):890-898. doi:10.1001/jamainternmed.2014.949
  17. Maloney R, Funmilayo M. Acting on the AUDIT-C: implementation of direct-to-consumer education on unhealth alcohol use. Presented on March 31, 2023; Central Virginia Veterans Affairs Health Care System, Richmond, Virginia.
  18. US Department of Veterans Affairs, Pharmacy Benefit Management Service. Alcohol use disorder (AUD) – leading the charge in the treatment of AUD: a VA clinician’s guide. February 2022. Accessed February 5, 2025. https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/508/10-1530_AUD_ClinicianGuide_508Conformant.pdf
  19. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46(3):399-424. doi:10.1080/00273171.2011.568786
  20. National Institute on Alcohol Abuse and Alcoholism. Stigma: overcoming a pervasive barrier to optimal care. Updated January 6, 2025. Accessed February 5, 2025. https://www.niaaa.nih.gov/health-professionals-communities/core-resource-on-alcohol/stigma-overcoming-pervasive-barrier-optimal-care
  21. Sudhinaraset M, Wigglesworth C, Takeuchi DT. Social and cultural contexts of alcohol use: influences in a socialecological framework. Alcohol Res. 2016;38(1):35-45.
  22. Tanski SE, McClure AC, Li Z, et al. Cued recall of alcohol advertising on television and underage drinking behavior. JAMA Pediatr. 2015;169(3):264-271. doi:10.1001/jamapediatrics.2014.3345
  23. Hyland CJ, McDowell MJ, Bain PA, Huskamp HA, Busch AB. Integration of pharmacotherapy for alcohol use disorder treatment in primary care settings: a scoping review. J Subst Abuse Treat. 2023;144:108919. doi:10.1016/j.jsat.2022.108919
  24. National Institute on Alcohol Abuse and Alcoholism. The truth about holiday spirits. Updated November 2023. Accessed February 5, 2025. ,a href="https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits">https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/truth-about-holiday-spirits
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Comparison of Prescribing Patterns of Intranasal Naloxone in a Veteran Population

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Comparison of Prescribing Patterns of Intranasal Naloxone in a Veteran Population

Since 1999, annual deaths attributed to opioid overdose in the United States have increased from about 10,000 to about 50,000 in 2019.1 During the COVID-19 pandemic > 74,000 opioid overdose deaths occurred in the US from April 2020 to April 2021.2,3 Opioid-related overdoses now account for about 75% of all drug-related overdose deaths.1 In 2017, the cost of opioid overdose deaths and opioid use disorder (OUD) reached $1.02 trillion in the United States and $26 million in Indiana.4 The total deaths and costs would likely be higher if it were not for naloxone.

Naloxone hydrochloride was first patented in the 1960s and approved by the US Food and Drug Administration (FDA) in 1971 to treat opioid-related toxicity.1 It is the most frequently prescribed antidote for opioid toxicity due to its activity as a pure υ-opioid receptor competitive antagonist. Naloxone formulations include intramuscular, intravenous, subcutaneous, and intranasal delivery methods.5 According to the Centers for Disease Control and Prevention, clinicians should offer naloxone to patients at high risk for opioid-related adverse events. Risk factors include a history of overdose, opioid dosages of ≥ 50 morphine mg equivalents/day, and concurrent use of opioids with benzodiazepines.6

Intranasal naloxone 4 mg has become more accessible following the classification of opioid use as a public health emergency in 2017 and its over-the-counter availability since 2023. Intranasal naloxone 4 mg was approved by the FDA in 2015 for the prevention of opioid overdoses (accidental or intentional), which can be caused by heroin, fentanyl, carfentanil, hydrocodone, oxycodone, methadone, and other substances. 7 Fentanyl has most recently been associated with xylazine, a nonopioid tranquilizer linked to increased opioid overdose deaths.8 Recent data suggest that 34% of opioid overdose reversals involved ≥ 2 doses of intranasal naloxone 4 mg, which led to FDA approval of an intranasal naloxone 8 mg spray in April 2021.9-11

Veteran Health Indiana (VHI) has implemented several initiatives to promote naloxone prescribing. Established in 2020, the Opioid Overdose Education and Naloxone Distribution (OEND) program sought to prevent opioid-related deaths through education and product distribution. These criteria included an opioid prescription for ≥ 30 days. In 2021, the Stratification Tool for Opioid Risk Mitigation (STORM) was created to identify patients at high risk of opioid overdose and allowing pharmacists to prescribe naloxone for at-risk patients without restrictions, increasing accessibility.12

Recent cases of fentanyl-related overdoses involving stronger fentanyl analogues highlight the need for higher naloxone dosing to prevent overdose. A pharmacokinetic comparison of intranasal naloxone 8 mg vs 4 mg demonstrated maximum plasma concentrations of 10.3 ng/mL and 5.3 ng/mL, respectively. 13 Patients may be at an increased risk of precipitated opioid withdrawal when using intranasal naloxone 8 mg over 4 mg; however, some patients may benefit from achieving higher serum concentrations and therefore require larger doses of naloxone.

No clinical trials have demonstrated a difference in reversal rates between naloxone doses. No clinical practice guidelines support a specific naloxone formulation, and limited US Department of Veterans Affairs (VA)-specific guidance exists. VA Naloxone Rescue: Recommendations for Use states that selection of naloxone 8 mg should be based on shared decision-making between the patient and clinician and based on individual risk factors.12 The purpose of this study is to analyze data to determine if there is a difference in prescribing patterns of intranasal naloxone 4 mg and intranasal naloxone 8 mg.

METHODS

A retrospective chart reviews using the VA Computerized Patient Record System (CPRS) analyzed patients prescribed intranasal naloxone 4 mg or intranasal naloxone 8 mg at VHI. A patient list was generated based on active naloxone prescriptions between April 1, 2022, and April 1, 2023. Data were obtained exclusively through CPRS and patients were not contacted. This study was reviewed and deemed exempt by the Indiana University Health Institutional Review Board and the VHI Research and Development Committee.

Patients were included if they were aged ≥ 18 years and had an active prescription for intranasal naloxone 4 mg or intranasal naloxone 8 mg during the trial period. Patients were excluded if their naloxone prescription was written by a non-VHI clinician, if the dose was not 4 mg or 8 mg, or if the dosage form was other than intranasal spray.

The primary endpoint was the comparison for prescribing patterns for intranasal naloxone 4 mg and intranasal naloxone 8 mg during the study period. Secondary endpoints included total naloxone prescriptions; monthly prescriptions; number of patients with repeated naloxone prescriptions; prescriber type by naloxone dose; clinic type by naloxone dose; and documented indication for naloxone use by dose.

Demographic data collected included baseline age, sex, race, comorbid mental health conditions, and active central nervous system depressant medications on patient profile (ie, opioids, gabapentinoids, benzodiazepines, antidepressants, antipsychotics). Opioid prescriptions that were active or discontinued within the last 3 months were also recorded. Comorbid mental health conditions were collected based on the most recent clinical note before initiating medication.

Prescription-related data included strength of medication prescribed (4 mg, 8 mg, or both), documented use of medication, prescriber name, prescriber discipline, prescription entered by, number of times naloxone was filled or refilled during the study period, indication, clinic location, and clinic name. If > 1 prescription was active during the study period, the number of refills, prescriber name and clinic location of the first prescription in the study period was recorded. Additionally, the indication of OUD was differentiated from substance use disorder (SUD) if the patient was only dependent on opioids, excluding tobacco or alcohol. Patients with SUDs may include opioid dependence in addition to other substance dependence (eg, cannabis, stimulants, gabapentinoids, or benzodiazepines).

Basic descriptive statistics, including mean, ranges, and percentages were used to characterize the study subjects. For nominal data, X2 tests were used. A 2-sided 5% significance level was used for all statistical tests.

RESULTS

A total of 1952 active naloxone prescriptions from 1739 patients met the inclusion criteria; none were eliminated based on the exclusion criteria and some were included multiple times because data were collected for each active prescription during the study period. One hundred one patients were randomized and included in the final analysis (Figure). Most patients identified as White (81%), male (90%), and had a mean (SD) age of 60.9 (14.2) years. Common mental health comorbidities included 59 patients with depression, 50 with tobacco use disorder, and 31 with anxiety. Eighty-four patients had opioid and 60 had antidepressants/antianxiety, and 40 had gabapentinoids prescriptions. Forty-three patients had ≥ 3 mental health comorbidities. Thirty-four patients had 2 active central nervous system depressant prescriptions, 30 had 3 active prescriptions, and 9 had ≥ 4 active prescriptions. Most patients (n = 83) had an active or recently discontinued opioid prescription (Table 1).

FDP04205204_F1FDP04205204_T1

The 101 patients received 54 prescriptions for naloxone 8 mg and 47 for 4 mg (Table 2). Five patients received prescriptions for both the 4 mg and 8 mg intranasal naloxone formulations. Sixty-six patients had naloxone filled once (66%) during the study period. Intranasal naloxone 4 mg was prescribed to 30 patients by nurse practitioners, 17 patients by physicians, and not prescribed by pharmacists. Intranasal naloxone 8 mg was prescribed to 40 patients by pharmacists, 13 patients by physicians, and 6 patients by nurses. Patients who received prescriptions for both intranasal naloxone 4 mg and 8 mg were most routinely ordered by physicians (n = 3; 60%) in primary care (n = 2; 40%) for chronic opioid use (n = 2; 40%).

FDP04205204_T2

Patients access naloxone from many different VHI clinics. Primary care clinics prescribed the 4 mg formulation to 31 patients, 8 mg to 3 patients, and both to 2 patients. The STORM initiative was used for 37 of 106 prescriptions (35%): 4 mg intranasal naloxone was prescribed to 1 patient, 8 mg to 36 patients, and no patients received both formulations. Chronic opioid use was the most common indication (46%) with 30 patients prescribed intranasal naloxone 4 mg, 14 patients prescribed 8 mg, and 2 patients prescribed both. OUD was the indication for 24% of patients: 2 patients prescribed intranasal naloxone 4 mg, 21 patients prescribed 8 mg, and 1 patient prescribed both.

The 106 intranasal naloxone prescriptions were equally distributed across each month from April 1, 2022, to April 1, 2023. Of the 101 patients, 34 had multiple naloxone prescriptions filled during the study period. Pharmacists wrote 40 of 106 naloxone prescriptions (38%), all for the 8 mg formulation. Nurse practitioners prescribed naloxone 4 mg 30 times and 8 mg 6 times for 36 of 106 prescriptions (34%). Physicians prescribed 30 of 106 prescriptions (28%), including intranasal naloxone 4 mg 17 times and 8 mg 13 times.

Statistics were analyzed using a X2 test; however, it was determined that the expected frequencies made the tests inappropriate. Differences in prescribing patterns between naloxone doses, prescriber disciplines, source of the prescription, or indications were not statistically significant.

DISCUSSION

Many pharmacists possess a scope of practice under state law and/or institution policy to prescribe naloxone. In this study, pharmacists prescribed the most naloxone prescriptions compared to physicians and nurse practitioners. Initiatives such as OEND and STORM have given pharmacists at VHI an avenue to combat the growing opioid epidemic while expanding their scope of practice. A systematic review of 67 studies found that pharmacist-led OEND programs showed a statistically significant increase in naloxone orders. A statistical significance was likely met given the large sample sizes ranging from 10 to 217,000 individuals, whereas this study only assessed a small portion of patients.14 This study contributes to the overwhelming amount of data that highlights pharmacists’ impact on overall naloxone distribution.

The STORM initiative and primary care clinics were responsible for large portions of naloxone prescriptions in this study. STORM was used by pharmacists and contributed to more than half of the higher dose naloxone prescriptions. Following a discussion with members of the pain management team, pharmacists involved in STORM prescribing were revealed to exclusively prescribe intranasal naloxone 8 mg as opposed to 4 mg. At the risk of precipitating withdrawal from higher doses of naloxone, it was agreed that this risk was heavily outweighed by the benefit of successful opioid reversal. In this context, it is expected for this avenue of prescribing to influence naloxone prescribing patterns at VHI.

Prescribing in primary care clinics was shown to be equally as substantial. Primary care-based multidisciplinary transition clinics have been reported to be associated with increased access to OUD treatment.15 Primary care clinics at VHI, or patient aligned care teams (PACT), largely consist of multidisciplinary health care teams. PACT clinicians are heavily involved in transitions of care because one system provides patients with comprehensive acute and chronic care. Continuing to encourage naloxone distribution through primary care and using STORM affords various patient populations access to high-level care.

Notable differences were observed between indications for naloxone use and the corresponding dose. Patients with OUD or SUD were more likely to receive intranasal naloxone 8 mg as opposed to patients receiving intranasal naloxone for chronic opioid use, who were more likely to receive the 4 mg dose. This may be due to a rationale to provide a higher dose of naloxone to combat overdoses in the case of ingesting substances mixed with fentanyl or xylazine.12,13 Without standard of care guidelines, concerns remain for varying outcomes in opioid overdose prevention within vulnerable populations.

Limitations

Chart data were dependent on documentation, which may have omitted pertinent baseline characteristics and risk factors. Additional data collection could have further assessed a patient’s specific risk factors (eg, opioid dose in morphine equivalents) to draw conclusions to the dose of naloxone prescribed. The sample size was small, and the patient population was largely White and male, which minimized the generalizability of the results.

CONCLUSIONS

This study evaluated the differences in intranasal naloxone prescribing patterns within a veteran population at VHI over 12 months. Findings revealed that most prescriptions were written for intranasal naloxone 8 mg, by a pharmacist, in a primary care setting, and for chronic opioid use. The results revealed evidence of differing naloxone prescribing practices, which emphasize the need for clinical guidelines and better defined recommendations in relation to naloxone dosing.

The most evident gap in patient care could be addressed by urging the VA Pharmacy Benefits Management group to update naloxone recommendations for use to include more concrete dosing recommendations. Furthermore, it would be beneficial to re-educate clinicians on naloxone prescribing to increase awareness of different doses and the importance of equipping patients with the correct amount of naloxone in an emergency. Additional research assessing change in prescribing patterns is warranted as the use of higher dose naloxone becomes more routine.

References
  1. Britch SC, Walsh SL. Treatment of opioid overdose: current approaches and recent advances. Psychopharmacology (Berl). 2022;239(7):2063-2081. doi:10.1007/s00213-022-06125-5
  2. Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional Drug Overdose Death Counts. National Center for Health Statistics, Centers for Disease Control and Prevention; 2023. Accessed April 10, 2025. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
  3. O’Donnell J, Tanz LJ, Gladden RM, Davis NL, Bitting J. Trends in and characteristics of drug overdose deaths involving illicitly manufactured fentanyls — United States, 2019–2020. MMWR Morb Mortal Wkly Rep. 2021;70:1740-1746. doi:10.15585/mmwr.mm7050e3
  4. Luo F, Li M, Florence C. State-level economic costs of opioid use disorder and fatal opioid overdose — United States, 2017. MMWR Morb Mortal Wkly Rep. 2021;70:541-546. doi:10.15585/mmwr.mm7015a1
  5. Lexicomp. Lexicomp Online. Accessed April 10, 2025. http://online.lexi.com
  6. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical practice guideline for prescribing opioids for pain — United States, 2022. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1
  7. Narcan (naloxone) FDA approval history. Drugs.com. Accessed April 10, 2025. https://www.drugs.com/history/narcan.html
  8. Centers for Disease Control and Prevention. What you should know about xylazine. May 16, 2024. Accessed April 10, 2025. https://www.cdc.gov/overdose-prevention/about/what-you-should-know-about-xylazine.html
  9. Avetian GK, Fiuty P, Mazzella S, Koppa D, Heye V, Hebbar P. Use of naloxone nasal spray 4 mg in the community setting: a survey of use by community organizations. Curr Med Res Opin. 2018;34(4):573-576. doi:10.1080/03007995.2017.1334637
  10. Kloxxado [package insert]. Hikma Pharmaceuticals USA Inc; 2021.
  11. FDA approves higher dosage of naloxone nasal spray to treat opioid overdose. News release. FDA. April 30, 2021. Accessed April 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose
  12. US Department of Veterans Affairs, Pharmacy Benefits Management Services and National Formulary Committee in Collaboration with the VA National Harm Reduction Support & Development Workgroup. Naloxone Rescue: Recommendations for Use. June 2014. Updated March 2024. Accessed April 10, 2025. https://www.va.gov/formularyadvisor/DOC_PDF/CRE_Naloxone_Rescue_Guidance_March_2024.pdf
  13. Krieter P, Chiang N, Gyaw S, et al. Pharmacokinetic properties and human use characteristics of an FDA-approved intranasal naloxone product for the treatment of opioid overdose. J Clin Pharmacol. 2016;56(10):1243-1253. doi:10.1002/jcph.759
  14. Rawal S, Osae SP, Cobran EK, Albert A, Young HN. Pharmacists’ naloxone services beyond community pharmacy settings: a systematic review. Res Social Adm Pharm. 2023;19(2):243-265. doi:10.1016/j.sapharm.2022.09.002
  15. Incze MA, Sehgal SL, Hansen A, Garcia L, Stolebarger L. Evaluation of a primary care-based multidisciplinary transition clinic for patients newly initiated on buprenorphine in the emergency department. Subst Abus. 2023;44(3):220-225. doi:10.1177/08897077231188592
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Maridith R. Hebenstreit, PharmDa; Allison D. Rodriguez, PharmDb; Allison Veide, PharmD, BCPSc; Talia Miles, PharmD, BCPP, BCPSa

Author affiliations
aVeteran Affairs Indiana Healthcare System, Indianapolis
bIndiana University Health, Indianapolis
cVeterans Affairs Northeast Ohio Healthcare System, Cleveland

Author disclosures
The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Correspondence: Maridith Hebenstreit (maridith.hebenstreit@va.gov)

Fed Pract. 2025;42(5). Published online May 15. doi:10.12788/fp.0591

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Maridith R. Hebenstreit, PharmDa; Allison D. Rodriguez, PharmDb; Allison Veide, PharmD, BCPSc; Talia Miles, PharmD, BCPP, BCPSa

Author affiliations
aVeteran Affairs Indiana Healthcare System, Indianapolis
bIndiana University Health, Indianapolis
cVeterans Affairs Northeast Ohio Healthcare System, Cleveland

Author disclosures
The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Correspondence: Maridith Hebenstreit (maridith.hebenstreit@va.gov)

Fed Pract. 2025;42(5). Published online May 15. doi:10.12788/fp.0591

Author and Disclosure Information

Maridith R. Hebenstreit, PharmDa; Allison D. Rodriguez, PharmDb; Allison Veide, PharmD, BCPSc; Talia Miles, PharmD, BCPP, BCPSa

Author affiliations
aVeteran Affairs Indiana Healthcare System, Indianapolis
bIndiana University Health, Indianapolis
cVeterans Affairs Northeast Ohio Healthcare System, Cleveland

Author disclosures
The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Correspondence: Maridith Hebenstreit (maridith.hebenstreit@va.gov)

Fed Pract. 2025;42(5). Published online May 15. doi:10.12788/fp.0591

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Article PDF

Since 1999, annual deaths attributed to opioid overdose in the United States have increased from about 10,000 to about 50,000 in 2019.1 During the COVID-19 pandemic > 74,000 opioid overdose deaths occurred in the US from April 2020 to April 2021.2,3 Opioid-related overdoses now account for about 75% of all drug-related overdose deaths.1 In 2017, the cost of opioid overdose deaths and opioid use disorder (OUD) reached $1.02 trillion in the United States and $26 million in Indiana.4 The total deaths and costs would likely be higher if it were not for naloxone.

Naloxone hydrochloride was first patented in the 1960s and approved by the US Food and Drug Administration (FDA) in 1971 to treat opioid-related toxicity.1 It is the most frequently prescribed antidote for opioid toxicity due to its activity as a pure υ-opioid receptor competitive antagonist. Naloxone formulations include intramuscular, intravenous, subcutaneous, and intranasal delivery methods.5 According to the Centers for Disease Control and Prevention, clinicians should offer naloxone to patients at high risk for opioid-related adverse events. Risk factors include a history of overdose, opioid dosages of ≥ 50 morphine mg equivalents/day, and concurrent use of opioids with benzodiazepines.6

Intranasal naloxone 4 mg has become more accessible following the classification of opioid use as a public health emergency in 2017 and its over-the-counter availability since 2023. Intranasal naloxone 4 mg was approved by the FDA in 2015 for the prevention of opioid overdoses (accidental or intentional), which can be caused by heroin, fentanyl, carfentanil, hydrocodone, oxycodone, methadone, and other substances. 7 Fentanyl has most recently been associated with xylazine, a nonopioid tranquilizer linked to increased opioid overdose deaths.8 Recent data suggest that 34% of opioid overdose reversals involved ≥ 2 doses of intranasal naloxone 4 mg, which led to FDA approval of an intranasal naloxone 8 mg spray in April 2021.9-11

Veteran Health Indiana (VHI) has implemented several initiatives to promote naloxone prescribing. Established in 2020, the Opioid Overdose Education and Naloxone Distribution (OEND) program sought to prevent opioid-related deaths through education and product distribution. These criteria included an opioid prescription for ≥ 30 days. In 2021, the Stratification Tool for Opioid Risk Mitigation (STORM) was created to identify patients at high risk of opioid overdose and allowing pharmacists to prescribe naloxone for at-risk patients without restrictions, increasing accessibility.12

Recent cases of fentanyl-related overdoses involving stronger fentanyl analogues highlight the need for higher naloxone dosing to prevent overdose. A pharmacokinetic comparison of intranasal naloxone 8 mg vs 4 mg demonstrated maximum plasma concentrations of 10.3 ng/mL and 5.3 ng/mL, respectively. 13 Patients may be at an increased risk of precipitated opioid withdrawal when using intranasal naloxone 8 mg over 4 mg; however, some patients may benefit from achieving higher serum concentrations and therefore require larger doses of naloxone.

No clinical trials have demonstrated a difference in reversal rates between naloxone doses. No clinical practice guidelines support a specific naloxone formulation, and limited US Department of Veterans Affairs (VA)-specific guidance exists. VA Naloxone Rescue: Recommendations for Use states that selection of naloxone 8 mg should be based on shared decision-making between the patient and clinician and based on individual risk factors.12 The purpose of this study is to analyze data to determine if there is a difference in prescribing patterns of intranasal naloxone 4 mg and intranasal naloxone 8 mg.

METHODS

A retrospective chart reviews using the VA Computerized Patient Record System (CPRS) analyzed patients prescribed intranasal naloxone 4 mg or intranasal naloxone 8 mg at VHI. A patient list was generated based on active naloxone prescriptions between April 1, 2022, and April 1, 2023. Data were obtained exclusively through CPRS and patients were not contacted. This study was reviewed and deemed exempt by the Indiana University Health Institutional Review Board and the VHI Research and Development Committee.

Patients were included if they were aged ≥ 18 years and had an active prescription for intranasal naloxone 4 mg or intranasal naloxone 8 mg during the trial period. Patients were excluded if their naloxone prescription was written by a non-VHI clinician, if the dose was not 4 mg or 8 mg, or if the dosage form was other than intranasal spray.

The primary endpoint was the comparison for prescribing patterns for intranasal naloxone 4 mg and intranasal naloxone 8 mg during the study period. Secondary endpoints included total naloxone prescriptions; monthly prescriptions; number of patients with repeated naloxone prescriptions; prescriber type by naloxone dose; clinic type by naloxone dose; and documented indication for naloxone use by dose.

Demographic data collected included baseline age, sex, race, comorbid mental health conditions, and active central nervous system depressant medications on patient profile (ie, opioids, gabapentinoids, benzodiazepines, antidepressants, antipsychotics). Opioid prescriptions that were active or discontinued within the last 3 months were also recorded. Comorbid mental health conditions were collected based on the most recent clinical note before initiating medication.

Prescription-related data included strength of medication prescribed (4 mg, 8 mg, or both), documented use of medication, prescriber name, prescriber discipline, prescription entered by, number of times naloxone was filled or refilled during the study period, indication, clinic location, and clinic name. If > 1 prescription was active during the study period, the number of refills, prescriber name and clinic location of the first prescription in the study period was recorded. Additionally, the indication of OUD was differentiated from substance use disorder (SUD) if the patient was only dependent on opioids, excluding tobacco or alcohol. Patients with SUDs may include opioid dependence in addition to other substance dependence (eg, cannabis, stimulants, gabapentinoids, or benzodiazepines).

Basic descriptive statistics, including mean, ranges, and percentages were used to characterize the study subjects. For nominal data, X2 tests were used. A 2-sided 5% significance level was used for all statistical tests.

RESULTS

A total of 1952 active naloxone prescriptions from 1739 patients met the inclusion criteria; none were eliminated based on the exclusion criteria and some were included multiple times because data were collected for each active prescription during the study period. One hundred one patients were randomized and included in the final analysis (Figure). Most patients identified as White (81%), male (90%), and had a mean (SD) age of 60.9 (14.2) years. Common mental health comorbidities included 59 patients with depression, 50 with tobacco use disorder, and 31 with anxiety. Eighty-four patients had opioid and 60 had antidepressants/antianxiety, and 40 had gabapentinoids prescriptions. Forty-three patients had ≥ 3 mental health comorbidities. Thirty-four patients had 2 active central nervous system depressant prescriptions, 30 had 3 active prescriptions, and 9 had ≥ 4 active prescriptions. Most patients (n = 83) had an active or recently discontinued opioid prescription (Table 1).

FDP04205204_F1FDP04205204_T1

The 101 patients received 54 prescriptions for naloxone 8 mg and 47 for 4 mg (Table 2). Five patients received prescriptions for both the 4 mg and 8 mg intranasal naloxone formulations. Sixty-six patients had naloxone filled once (66%) during the study period. Intranasal naloxone 4 mg was prescribed to 30 patients by nurse practitioners, 17 patients by physicians, and not prescribed by pharmacists. Intranasal naloxone 8 mg was prescribed to 40 patients by pharmacists, 13 patients by physicians, and 6 patients by nurses. Patients who received prescriptions for both intranasal naloxone 4 mg and 8 mg were most routinely ordered by physicians (n = 3; 60%) in primary care (n = 2; 40%) for chronic opioid use (n = 2; 40%).

FDP04205204_T2

Patients access naloxone from many different VHI clinics. Primary care clinics prescribed the 4 mg formulation to 31 patients, 8 mg to 3 patients, and both to 2 patients. The STORM initiative was used for 37 of 106 prescriptions (35%): 4 mg intranasal naloxone was prescribed to 1 patient, 8 mg to 36 patients, and no patients received both formulations. Chronic opioid use was the most common indication (46%) with 30 patients prescribed intranasal naloxone 4 mg, 14 patients prescribed 8 mg, and 2 patients prescribed both. OUD was the indication for 24% of patients: 2 patients prescribed intranasal naloxone 4 mg, 21 patients prescribed 8 mg, and 1 patient prescribed both.

The 106 intranasal naloxone prescriptions were equally distributed across each month from April 1, 2022, to April 1, 2023. Of the 101 patients, 34 had multiple naloxone prescriptions filled during the study period. Pharmacists wrote 40 of 106 naloxone prescriptions (38%), all for the 8 mg formulation. Nurse practitioners prescribed naloxone 4 mg 30 times and 8 mg 6 times for 36 of 106 prescriptions (34%). Physicians prescribed 30 of 106 prescriptions (28%), including intranasal naloxone 4 mg 17 times and 8 mg 13 times.

Statistics were analyzed using a X2 test; however, it was determined that the expected frequencies made the tests inappropriate. Differences in prescribing patterns between naloxone doses, prescriber disciplines, source of the prescription, or indications were not statistically significant.

DISCUSSION

Many pharmacists possess a scope of practice under state law and/or institution policy to prescribe naloxone. In this study, pharmacists prescribed the most naloxone prescriptions compared to physicians and nurse practitioners. Initiatives such as OEND and STORM have given pharmacists at VHI an avenue to combat the growing opioid epidemic while expanding their scope of practice. A systematic review of 67 studies found that pharmacist-led OEND programs showed a statistically significant increase in naloxone orders. A statistical significance was likely met given the large sample sizes ranging from 10 to 217,000 individuals, whereas this study only assessed a small portion of patients.14 This study contributes to the overwhelming amount of data that highlights pharmacists’ impact on overall naloxone distribution.

The STORM initiative and primary care clinics were responsible for large portions of naloxone prescriptions in this study. STORM was used by pharmacists and contributed to more than half of the higher dose naloxone prescriptions. Following a discussion with members of the pain management team, pharmacists involved in STORM prescribing were revealed to exclusively prescribe intranasal naloxone 8 mg as opposed to 4 mg. At the risk of precipitating withdrawal from higher doses of naloxone, it was agreed that this risk was heavily outweighed by the benefit of successful opioid reversal. In this context, it is expected for this avenue of prescribing to influence naloxone prescribing patterns at VHI.

Prescribing in primary care clinics was shown to be equally as substantial. Primary care-based multidisciplinary transition clinics have been reported to be associated with increased access to OUD treatment.15 Primary care clinics at VHI, or patient aligned care teams (PACT), largely consist of multidisciplinary health care teams. PACT clinicians are heavily involved in transitions of care because one system provides patients with comprehensive acute and chronic care. Continuing to encourage naloxone distribution through primary care and using STORM affords various patient populations access to high-level care.

Notable differences were observed between indications for naloxone use and the corresponding dose. Patients with OUD or SUD were more likely to receive intranasal naloxone 8 mg as opposed to patients receiving intranasal naloxone for chronic opioid use, who were more likely to receive the 4 mg dose. This may be due to a rationale to provide a higher dose of naloxone to combat overdoses in the case of ingesting substances mixed with fentanyl or xylazine.12,13 Without standard of care guidelines, concerns remain for varying outcomes in opioid overdose prevention within vulnerable populations.

Limitations

Chart data were dependent on documentation, which may have omitted pertinent baseline characteristics and risk factors. Additional data collection could have further assessed a patient’s specific risk factors (eg, opioid dose in morphine equivalents) to draw conclusions to the dose of naloxone prescribed. The sample size was small, and the patient population was largely White and male, which minimized the generalizability of the results.

CONCLUSIONS

This study evaluated the differences in intranasal naloxone prescribing patterns within a veteran population at VHI over 12 months. Findings revealed that most prescriptions were written for intranasal naloxone 8 mg, by a pharmacist, in a primary care setting, and for chronic opioid use. The results revealed evidence of differing naloxone prescribing practices, which emphasize the need for clinical guidelines and better defined recommendations in relation to naloxone dosing.

The most evident gap in patient care could be addressed by urging the VA Pharmacy Benefits Management group to update naloxone recommendations for use to include more concrete dosing recommendations. Furthermore, it would be beneficial to re-educate clinicians on naloxone prescribing to increase awareness of different doses and the importance of equipping patients with the correct amount of naloxone in an emergency. Additional research assessing change in prescribing patterns is warranted as the use of higher dose naloxone becomes more routine.

Since 1999, annual deaths attributed to opioid overdose in the United States have increased from about 10,000 to about 50,000 in 2019.1 During the COVID-19 pandemic > 74,000 opioid overdose deaths occurred in the US from April 2020 to April 2021.2,3 Opioid-related overdoses now account for about 75% of all drug-related overdose deaths.1 In 2017, the cost of opioid overdose deaths and opioid use disorder (OUD) reached $1.02 trillion in the United States and $26 million in Indiana.4 The total deaths and costs would likely be higher if it were not for naloxone.

Naloxone hydrochloride was first patented in the 1960s and approved by the US Food and Drug Administration (FDA) in 1971 to treat opioid-related toxicity.1 It is the most frequently prescribed antidote for opioid toxicity due to its activity as a pure υ-opioid receptor competitive antagonist. Naloxone formulations include intramuscular, intravenous, subcutaneous, and intranasal delivery methods.5 According to the Centers for Disease Control and Prevention, clinicians should offer naloxone to patients at high risk for opioid-related adverse events. Risk factors include a history of overdose, opioid dosages of ≥ 50 morphine mg equivalents/day, and concurrent use of opioids with benzodiazepines.6

Intranasal naloxone 4 mg has become more accessible following the classification of opioid use as a public health emergency in 2017 and its over-the-counter availability since 2023. Intranasal naloxone 4 mg was approved by the FDA in 2015 for the prevention of opioid overdoses (accidental or intentional), which can be caused by heroin, fentanyl, carfentanil, hydrocodone, oxycodone, methadone, and other substances. 7 Fentanyl has most recently been associated with xylazine, a nonopioid tranquilizer linked to increased opioid overdose deaths.8 Recent data suggest that 34% of opioid overdose reversals involved ≥ 2 doses of intranasal naloxone 4 mg, which led to FDA approval of an intranasal naloxone 8 mg spray in April 2021.9-11

Veteran Health Indiana (VHI) has implemented several initiatives to promote naloxone prescribing. Established in 2020, the Opioid Overdose Education and Naloxone Distribution (OEND) program sought to prevent opioid-related deaths through education and product distribution. These criteria included an opioid prescription for ≥ 30 days. In 2021, the Stratification Tool for Opioid Risk Mitigation (STORM) was created to identify patients at high risk of opioid overdose and allowing pharmacists to prescribe naloxone for at-risk patients without restrictions, increasing accessibility.12

Recent cases of fentanyl-related overdoses involving stronger fentanyl analogues highlight the need for higher naloxone dosing to prevent overdose. A pharmacokinetic comparison of intranasal naloxone 8 mg vs 4 mg demonstrated maximum plasma concentrations of 10.3 ng/mL and 5.3 ng/mL, respectively. 13 Patients may be at an increased risk of precipitated opioid withdrawal when using intranasal naloxone 8 mg over 4 mg; however, some patients may benefit from achieving higher serum concentrations and therefore require larger doses of naloxone.

No clinical trials have demonstrated a difference in reversal rates between naloxone doses. No clinical practice guidelines support a specific naloxone formulation, and limited US Department of Veterans Affairs (VA)-specific guidance exists. VA Naloxone Rescue: Recommendations for Use states that selection of naloxone 8 mg should be based on shared decision-making between the patient and clinician and based on individual risk factors.12 The purpose of this study is to analyze data to determine if there is a difference in prescribing patterns of intranasal naloxone 4 mg and intranasal naloxone 8 mg.

METHODS

A retrospective chart reviews using the VA Computerized Patient Record System (CPRS) analyzed patients prescribed intranasal naloxone 4 mg or intranasal naloxone 8 mg at VHI. A patient list was generated based on active naloxone prescriptions between April 1, 2022, and April 1, 2023. Data were obtained exclusively through CPRS and patients were not contacted. This study was reviewed and deemed exempt by the Indiana University Health Institutional Review Board and the VHI Research and Development Committee.

Patients were included if they were aged ≥ 18 years and had an active prescription for intranasal naloxone 4 mg or intranasal naloxone 8 mg during the trial period. Patients were excluded if their naloxone prescription was written by a non-VHI clinician, if the dose was not 4 mg or 8 mg, or if the dosage form was other than intranasal spray.

The primary endpoint was the comparison for prescribing patterns for intranasal naloxone 4 mg and intranasal naloxone 8 mg during the study period. Secondary endpoints included total naloxone prescriptions; monthly prescriptions; number of patients with repeated naloxone prescriptions; prescriber type by naloxone dose; clinic type by naloxone dose; and documented indication for naloxone use by dose.

Demographic data collected included baseline age, sex, race, comorbid mental health conditions, and active central nervous system depressant medications on patient profile (ie, opioids, gabapentinoids, benzodiazepines, antidepressants, antipsychotics). Opioid prescriptions that were active or discontinued within the last 3 months were also recorded. Comorbid mental health conditions were collected based on the most recent clinical note before initiating medication.

Prescription-related data included strength of medication prescribed (4 mg, 8 mg, or both), documented use of medication, prescriber name, prescriber discipline, prescription entered by, number of times naloxone was filled or refilled during the study period, indication, clinic location, and clinic name. If > 1 prescription was active during the study period, the number of refills, prescriber name and clinic location of the first prescription in the study period was recorded. Additionally, the indication of OUD was differentiated from substance use disorder (SUD) if the patient was only dependent on opioids, excluding tobacco or alcohol. Patients with SUDs may include opioid dependence in addition to other substance dependence (eg, cannabis, stimulants, gabapentinoids, or benzodiazepines).

Basic descriptive statistics, including mean, ranges, and percentages were used to characterize the study subjects. For nominal data, X2 tests were used. A 2-sided 5% significance level was used for all statistical tests.

RESULTS

A total of 1952 active naloxone prescriptions from 1739 patients met the inclusion criteria; none were eliminated based on the exclusion criteria and some were included multiple times because data were collected for each active prescription during the study period. One hundred one patients were randomized and included in the final analysis (Figure). Most patients identified as White (81%), male (90%), and had a mean (SD) age of 60.9 (14.2) years. Common mental health comorbidities included 59 patients with depression, 50 with tobacco use disorder, and 31 with anxiety. Eighty-four patients had opioid and 60 had antidepressants/antianxiety, and 40 had gabapentinoids prescriptions. Forty-three patients had ≥ 3 mental health comorbidities. Thirty-four patients had 2 active central nervous system depressant prescriptions, 30 had 3 active prescriptions, and 9 had ≥ 4 active prescriptions. Most patients (n = 83) had an active or recently discontinued opioid prescription (Table 1).

FDP04205204_F1FDP04205204_T1

The 101 patients received 54 prescriptions for naloxone 8 mg and 47 for 4 mg (Table 2). Five patients received prescriptions for both the 4 mg and 8 mg intranasal naloxone formulations. Sixty-six patients had naloxone filled once (66%) during the study period. Intranasal naloxone 4 mg was prescribed to 30 patients by nurse practitioners, 17 patients by physicians, and not prescribed by pharmacists. Intranasal naloxone 8 mg was prescribed to 40 patients by pharmacists, 13 patients by physicians, and 6 patients by nurses. Patients who received prescriptions for both intranasal naloxone 4 mg and 8 mg were most routinely ordered by physicians (n = 3; 60%) in primary care (n = 2; 40%) for chronic opioid use (n = 2; 40%).

FDP04205204_T2

Patients access naloxone from many different VHI clinics. Primary care clinics prescribed the 4 mg formulation to 31 patients, 8 mg to 3 patients, and both to 2 patients. The STORM initiative was used for 37 of 106 prescriptions (35%): 4 mg intranasal naloxone was prescribed to 1 patient, 8 mg to 36 patients, and no patients received both formulations. Chronic opioid use was the most common indication (46%) with 30 patients prescribed intranasal naloxone 4 mg, 14 patients prescribed 8 mg, and 2 patients prescribed both. OUD was the indication for 24% of patients: 2 patients prescribed intranasal naloxone 4 mg, 21 patients prescribed 8 mg, and 1 patient prescribed both.

The 106 intranasal naloxone prescriptions were equally distributed across each month from April 1, 2022, to April 1, 2023. Of the 101 patients, 34 had multiple naloxone prescriptions filled during the study period. Pharmacists wrote 40 of 106 naloxone prescriptions (38%), all for the 8 mg formulation. Nurse practitioners prescribed naloxone 4 mg 30 times and 8 mg 6 times for 36 of 106 prescriptions (34%). Physicians prescribed 30 of 106 prescriptions (28%), including intranasal naloxone 4 mg 17 times and 8 mg 13 times.

Statistics were analyzed using a X2 test; however, it was determined that the expected frequencies made the tests inappropriate. Differences in prescribing patterns between naloxone doses, prescriber disciplines, source of the prescription, or indications were not statistically significant.

DISCUSSION

Many pharmacists possess a scope of practice under state law and/or institution policy to prescribe naloxone. In this study, pharmacists prescribed the most naloxone prescriptions compared to physicians and nurse practitioners. Initiatives such as OEND and STORM have given pharmacists at VHI an avenue to combat the growing opioid epidemic while expanding their scope of practice. A systematic review of 67 studies found that pharmacist-led OEND programs showed a statistically significant increase in naloxone orders. A statistical significance was likely met given the large sample sizes ranging from 10 to 217,000 individuals, whereas this study only assessed a small portion of patients.14 This study contributes to the overwhelming amount of data that highlights pharmacists’ impact on overall naloxone distribution.

The STORM initiative and primary care clinics were responsible for large portions of naloxone prescriptions in this study. STORM was used by pharmacists and contributed to more than half of the higher dose naloxone prescriptions. Following a discussion with members of the pain management team, pharmacists involved in STORM prescribing were revealed to exclusively prescribe intranasal naloxone 8 mg as opposed to 4 mg. At the risk of precipitating withdrawal from higher doses of naloxone, it was agreed that this risk was heavily outweighed by the benefit of successful opioid reversal. In this context, it is expected for this avenue of prescribing to influence naloxone prescribing patterns at VHI.

Prescribing in primary care clinics was shown to be equally as substantial. Primary care-based multidisciplinary transition clinics have been reported to be associated with increased access to OUD treatment.15 Primary care clinics at VHI, or patient aligned care teams (PACT), largely consist of multidisciplinary health care teams. PACT clinicians are heavily involved in transitions of care because one system provides patients with comprehensive acute and chronic care. Continuing to encourage naloxone distribution through primary care and using STORM affords various patient populations access to high-level care.

Notable differences were observed between indications for naloxone use and the corresponding dose. Patients with OUD or SUD were more likely to receive intranasal naloxone 8 mg as opposed to patients receiving intranasal naloxone for chronic opioid use, who were more likely to receive the 4 mg dose. This may be due to a rationale to provide a higher dose of naloxone to combat overdoses in the case of ingesting substances mixed with fentanyl or xylazine.12,13 Without standard of care guidelines, concerns remain for varying outcomes in opioid overdose prevention within vulnerable populations.

Limitations

Chart data were dependent on documentation, which may have omitted pertinent baseline characteristics and risk factors. Additional data collection could have further assessed a patient’s specific risk factors (eg, opioid dose in morphine equivalents) to draw conclusions to the dose of naloxone prescribed. The sample size was small, and the patient population was largely White and male, which minimized the generalizability of the results.

CONCLUSIONS

This study evaluated the differences in intranasal naloxone prescribing patterns within a veteran population at VHI over 12 months. Findings revealed that most prescriptions were written for intranasal naloxone 8 mg, by a pharmacist, in a primary care setting, and for chronic opioid use. The results revealed evidence of differing naloxone prescribing practices, which emphasize the need for clinical guidelines and better defined recommendations in relation to naloxone dosing.

The most evident gap in patient care could be addressed by urging the VA Pharmacy Benefits Management group to update naloxone recommendations for use to include more concrete dosing recommendations. Furthermore, it would be beneficial to re-educate clinicians on naloxone prescribing to increase awareness of different doses and the importance of equipping patients with the correct amount of naloxone in an emergency. Additional research assessing change in prescribing patterns is warranted as the use of higher dose naloxone becomes more routine.

References
  1. Britch SC, Walsh SL. Treatment of opioid overdose: current approaches and recent advances. Psychopharmacology (Berl). 2022;239(7):2063-2081. doi:10.1007/s00213-022-06125-5
  2. Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional Drug Overdose Death Counts. National Center for Health Statistics, Centers for Disease Control and Prevention; 2023. Accessed April 10, 2025. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
  3. O’Donnell J, Tanz LJ, Gladden RM, Davis NL, Bitting J. Trends in and characteristics of drug overdose deaths involving illicitly manufactured fentanyls — United States, 2019–2020. MMWR Morb Mortal Wkly Rep. 2021;70:1740-1746. doi:10.15585/mmwr.mm7050e3
  4. Luo F, Li M, Florence C. State-level economic costs of opioid use disorder and fatal opioid overdose — United States, 2017. MMWR Morb Mortal Wkly Rep. 2021;70:541-546. doi:10.15585/mmwr.mm7015a1
  5. Lexicomp. Lexicomp Online. Accessed April 10, 2025. http://online.lexi.com
  6. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical practice guideline for prescribing opioids for pain — United States, 2022. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1
  7. Narcan (naloxone) FDA approval history. Drugs.com. Accessed April 10, 2025. https://www.drugs.com/history/narcan.html
  8. Centers for Disease Control and Prevention. What you should know about xylazine. May 16, 2024. Accessed April 10, 2025. https://www.cdc.gov/overdose-prevention/about/what-you-should-know-about-xylazine.html
  9. Avetian GK, Fiuty P, Mazzella S, Koppa D, Heye V, Hebbar P. Use of naloxone nasal spray 4 mg in the community setting: a survey of use by community organizations. Curr Med Res Opin. 2018;34(4):573-576. doi:10.1080/03007995.2017.1334637
  10. Kloxxado [package insert]. Hikma Pharmaceuticals USA Inc; 2021.
  11. FDA approves higher dosage of naloxone nasal spray to treat opioid overdose. News release. FDA. April 30, 2021. Accessed April 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose
  12. US Department of Veterans Affairs, Pharmacy Benefits Management Services and National Formulary Committee in Collaboration with the VA National Harm Reduction Support & Development Workgroup. Naloxone Rescue: Recommendations for Use. June 2014. Updated March 2024. Accessed April 10, 2025. https://www.va.gov/formularyadvisor/DOC_PDF/CRE_Naloxone_Rescue_Guidance_March_2024.pdf
  13. Krieter P, Chiang N, Gyaw S, et al. Pharmacokinetic properties and human use characteristics of an FDA-approved intranasal naloxone product for the treatment of opioid overdose. J Clin Pharmacol. 2016;56(10):1243-1253. doi:10.1002/jcph.759
  14. Rawal S, Osae SP, Cobran EK, Albert A, Young HN. Pharmacists’ naloxone services beyond community pharmacy settings: a systematic review. Res Social Adm Pharm. 2023;19(2):243-265. doi:10.1016/j.sapharm.2022.09.002
  15. Incze MA, Sehgal SL, Hansen A, Garcia L, Stolebarger L. Evaluation of a primary care-based multidisciplinary transition clinic for patients newly initiated on buprenorphine in the emergency department. Subst Abus. 2023;44(3):220-225. doi:10.1177/08897077231188592
References
  1. Britch SC, Walsh SL. Treatment of opioid overdose: current approaches and recent advances. Psychopharmacology (Berl). 2022;239(7):2063-2081. doi:10.1007/s00213-022-06125-5
  2. Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional Drug Overdose Death Counts. National Center for Health Statistics, Centers for Disease Control and Prevention; 2023. Accessed April 10, 2025. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
  3. O’Donnell J, Tanz LJ, Gladden RM, Davis NL, Bitting J. Trends in and characteristics of drug overdose deaths involving illicitly manufactured fentanyls — United States, 2019–2020. MMWR Morb Mortal Wkly Rep. 2021;70:1740-1746. doi:10.15585/mmwr.mm7050e3
  4. Luo F, Li M, Florence C. State-level economic costs of opioid use disorder and fatal opioid overdose — United States, 2017. MMWR Morb Mortal Wkly Rep. 2021;70:541-546. doi:10.15585/mmwr.mm7015a1
  5. Lexicomp. Lexicomp Online. Accessed April 10, 2025. http://online.lexi.com
  6. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical practice guideline for prescribing opioids for pain — United States, 2022. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1
  7. Narcan (naloxone) FDA approval history. Drugs.com. Accessed April 10, 2025. https://www.drugs.com/history/narcan.html
  8. Centers for Disease Control and Prevention. What you should know about xylazine. May 16, 2024. Accessed April 10, 2025. https://www.cdc.gov/overdose-prevention/about/what-you-should-know-about-xylazine.html
  9. Avetian GK, Fiuty P, Mazzella S, Koppa D, Heye V, Hebbar P. Use of naloxone nasal spray 4 mg in the community setting: a survey of use by community organizations. Curr Med Res Opin. 2018;34(4):573-576. doi:10.1080/03007995.2017.1334637
  10. Kloxxado [package insert]. Hikma Pharmaceuticals USA Inc; 2021.
  11. FDA approves higher dosage of naloxone nasal spray to treat opioid overdose. News release. FDA. April 30, 2021. Accessed April 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose
  12. US Department of Veterans Affairs, Pharmacy Benefits Management Services and National Formulary Committee in Collaboration with the VA National Harm Reduction Support & Development Workgroup. Naloxone Rescue: Recommendations for Use. June 2014. Updated March 2024. Accessed April 10, 2025. https://www.va.gov/formularyadvisor/DOC_PDF/CRE_Naloxone_Rescue_Guidance_March_2024.pdf
  13. Krieter P, Chiang N, Gyaw S, et al. Pharmacokinetic properties and human use characteristics of an FDA-approved intranasal naloxone product for the treatment of opioid overdose. J Clin Pharmacol. 2016;56(10):1243-1253. doi:10.1002/jcph.759
  14. Rawal S, Osae SP, Cobran EK, Albert A, Young HN. Pharmacists’ naloxone services beyond community pharmacy settings: a systematic review. Res Social Adm Pharm. 2023;19(2):243-265. doi:10.1016/j.sapharm.2022.09.002
  15. Incze MA, Sehgal SL, Hansen A, Garcia L, Stolebarger L. Evaluation of a primary care-based multidisciplinary transition clinic for patients newly initiated on buprenorphine in the emergency department. Subst Abus. 2023;44(3):220-225. doi:10.1177/08897077231188592
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Community Care Radiation Oncology Cost Calculations for a VA Medical Center

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Community Care Radiation Oncology Cost Calculations for a VA Medical Center

William Kissick’s description of health care’s iron triangle in 1994 still resonates. Access, quality, and cost will always come at the expense of the others.1 In 2018, Congress passed the VA MISSION Act, allowing patients to pursue community care options for extended waits (> 28 days) or longer distance drive times of > 60 minutes for specialty care services, such as radiation oncology. According to Albanese et al, the VA MISSION Act sought to address gaps in care for veterans living in rural and underserved areas.2 The Veterans Health Administration (VHA) continues to increase community care spending, with a 13.8% increase in fiscal year 2024 and an expected cost of > $40 billion for 2025.3 One could argue this pays for access for remote patients and quality when services are unavailable, making it a direct application of the iron triangle.

The VA MISSION Act also bolstered the expansion of existing community care department staff to expediently facilitate and coordinate care and payments.2 Cost management and monitoring have become critical in predicting future staff requirements, maintaining functionality, and ensuring patients receive optimal care. The VHA purchases care through partner networks and defines these bundled health care services as standard episodes of care (SEOCs), which are “clinically related health care services for a specific unique illness or medical condition… over a defined period of time.”4 Medicare publishes its rates quarterly, and outpatient procedure pricing is readily available online.5 Along these same lines, the US Department of Veterans Affairs (VA) publishes a current list of available procedures and associated Current Procedure Technology (CPT) codes that are covered under its VA fee schedule for community care.

Unique challenges persist when using this system to accurately account for radiation oncology expenditures. This study was based on the current practices at the Richard L. Roudebush VA Medical Center (RLRVAMC), a large 1a hospital. A detailed analysis reveals the contemporaneous cost of radiation oncology cancer care from October 1, 2021, through February 1, 2024, highlights the challenges in SEOC definition and duration, communication issues between RLRVAMC and purchase partners, inconsistencies in billing, erroneous payments, and difficulty of cost categorization.

METHODS

Community care radiation oncology-related costs were examined from October 1, 2021, to February 1, 2024 for RLRVAMC, 6 months prior to billing data extraction. Figure 1 shows a simple radiation oncology patient pathway with consultation or visit, simulation and planning, and treatment, with codes used to check billing. It illustrates the expected relationships between the VHA (radiation oncology, primary, and specialty care) and community care (clinicians and radiation oncology treatment sites).

0525FED-AVAHO-RAD_F1

VHA standard operating procedures for a patient requesting community-based radiation oncology care require a board-certified radiation oncologist at RLRVAMC to review and approve the outside care request. Community care radiation oncology consultation data were accessed from the VA Corporate Data Warehouse (CDW) using Pyramid Analytics (V25.2). Nurses, physicians, and community care staff can add comments, forward consultations to other services, and mark them as complete or discontinued, when appropriate. Consultations not completed within 91 days are automatically discontinued. All community care requests from 2018 through 2024 were extracted; analysis began April 1, 2021, 6 months prior to the cost evaluation date of October 1, 2021.

An approved consultation is reviewed for eligibility by a nurse in the community care department and assigned an authorization number (a VA prefix followed by 12 digits). Billing codes are approved and organized by the community care networks, and all procedure codes should be captured and labeled under this number. The VAMC Community Care department obtains initial correspondence from the treating clinicians. Subsequent records from the treating radiation oncologist are expected to be scanned into the electronic health record and made accessible via the VA Joint Legacy Viewer (JLV) and Computerized Patient Record System (CPRS).

Radiation Oncology SEOC

The start date of the radiation oncology SEOC is determined by the community care nurse based on guidance established by the VA. It can be manually backdated or delayed, but current practice is to start at first visit or procedure code entry after approval from the VAMC Radiation Oncology department. Approved CPT codes from SEOC versions between October 1, 2021, and February 1, 2024, are in eAppendix 1 (available at doi:10.12788/fp.0585). These generally include 10 types of encounters, about 115 different laboratory tests, 115 imaging studies, 25 simulation and planning procedures, and 115 radiation treatment codes. The radiation oncology SEOCs during the study period had an approval duration of 180 days. Advanced Medical Cost Management Solutions software (AMCMS) is the VHA data analytics platform for community care medical service costs. AMCMS includes all individual CPT codes billed by specific radiation oncology SEOC versions. Data are refreshed monthly, and all charges were extracted on September 12, 2024, > 6 months after the final evaluated service date to allow for complete billing returns.6

0525FED-AVAHO-RAD_eApp1
Radiation Oncology-Specific Costs

The VA Close to Me (CTM) program was used to find 84 specific radiation oncology CPT codes, nearly all within the 77.XXX or G6.XXX series, which included all radiation oncology-specific (ROS) codes (except visits accrued during consultation and return appointments). ROS costs are those that could not be performed by any other service and include procedures related to radiation oncology simulation, treatment planning, treatment delivery (with or without image guidance), and physician or physicist management. All ROS costs should be included in a patient’s radiation oncology SEOC. Other costs that may accompany operating room or brachytherapy administration did not follow a 77.XXX or G6.XXX pattern but were included in total radiation therapy operating costs.

Data obtained from AMCMS and CTM included patient name and identifier; CPT billed amount; CPT paid amount; dates of service; number of claims; International Classification of Diseases, Tenth Revision (ICD) diagnosis; and VA authorization numbers. Only CTM listed code modifiers. Only items categorized as paid were included in the analysis. Charges associated with discontinued consultations that had accrued costs also were included. Codes that were not directly related to ROS were separately characterized as other and further subcategorized.

Deep Dive Categorization

All scanned documents tagged to the community consultation were accessed and evaluated for completeness by a radiation oncologist (RS). The presence or absence of consultation notes and treatment summaries was evaluated based on necessity (ie, not needed for continuation of care or treatment was not given). In the absence of a specific completion summary or follow-up note detailing the treatment modality, number of fractions, and treatment sites, available documentation, including clinical notes and billing information, was used. Radical or curative therapies were identified as courses expected to eradicate disease, including stereotactic ablative radiotherapy to the brain, lung, liver, and other organs. Palliative therapies included whole-brain radiotherapy or other low-dose treatments. If the patient received the intended course, this was categorized as full. If incomplete, it was considered partial.

Billing Deviations

The complete document review allowed for close evaluation of paid therapy and identification of gaps in billing (eg, charges not found in extracted data that should have occurred) for external beam radiotherapy patients. Conversely, extra charges, such as an additional weekly treatment management charge (CPT code 77427), would be noted. Patients were expected to have the number of treatments specified in the summary, a clinical treatment planning code, and weekly treatment management notes from physicians and physicists every 5 fractions. Consultations and follow-up visits were expected to have 1 visit code; CPT codes 99205 and 99215, respectively, were used to estimate costs in their absence.

Costs were based on Medicare rates as of January 1 of the year in which they were accrued. 7-10 Duplicates were charges with the same code, date, billed quantity, and paid amounts for a given patient. These would always be considered erroneous. Medicare treatment costs for procedures such as intensity modulated radiotherapy (CPT code 77385 or 77386) are available on the Medicare website. When reviewing locality deviations for 77427, there was a maximum of 33% increase in Medicare rates. Therefore, for treatment codes, one would expect the range to be at least the Medicare rate and maximally 33% higher. These rates are negotiated with insurance companies, but this range was used for the purpose of reviewing and adjusting large data sets.

RESULTS

Since 2018, > 500 community care consults have been placed by radiation oncology for treatment in the community, with more following implementation of the VA MISSION Act. Use of radiation oncology community care services annually increased during the study period for this facility (Table 1, Figure 2). Of the 325 community care consults placed from October 1, 2021, to February 1, 2024, 248 radiation oncology SEOCs were recorded with charges for 181 patients (range, 1-5 SEOCs). Long drive time was the rationale for > 97% of patients directed to community care (Supplemental materials, available at doi:10.12788/fp.0585). Based on AMCMS data, $22.2 million was billed and $2.7 million was paid (20%) for 8747 CPT codes. Each community care interval cost the VA a median (range) of $5000 ($8-$168,000 (Figure 3).

0525FED-AVAHO-RAD_T10525FED-AVAHO-RAD_F20525FED-AVAHO-RAD_F3

After reviewing ROS charges extracted from CTM, 20 additional patients had radiation oncology charges but did not have a radiation oncology SEOC for 268 episodes of care for 201 unique patients. In addition to the 20 patients who did not have a SEOC, 42 nonradiation oncology SEOCs contained 1148 radiation oncology codes, corresponding to almost $500,000 paid. Additional charges of about $416,000, which included biologic agents (eg, durvalumab, nivolumab), procedures (eg, mastectomies), and ambulance rides were inappropriately added to radiation oncology SEOCs.

While 77% of consultations were scanned into CPRS and JLV, only 54% of completion summaries were available with an estimated $115,000 in additional costs. The total adjusted costs was about $2.9 million. Almost 37% of SEOCs were for visits only. For the 166 SEOCs where patients received any radiation treatment or planning, the median cost was $18,000. Differences in SEOC pathways are shown in Figure 4. One hundred twenty-one SEOCs (45%) followed the standard pathway, with median SEOC costs of $15,500; when corrected for radiation-specific costs, the median cost increased to $18,000. When adjusted for billing irregularities, the median cost was $20,600. Ninety-nine SEOCs (37%) were for consultation/ follow-up visits only, with a median cost of $220. When omitting shared scans and nonradiation therapy costs and correcting for billing gaps, the median cost decreased to $170. A median of $9200 was paid per patient, with $12,900 for radiation therapy-specific costs and $13,300 adjusted for billing deviations. Narrowing to the 106 patients who received full, radical courses, the median SEOC, ROS, and adjusted radiation therapy costs increased to $19,400, $22,200, and $22,900, respectively (Table 2, Figure 5). Seventy-one SEOCs (26%) had already seen a radiation oncologist before the VA radiation oncology department was aware, and 49 SEOCs (18%) had retroactive approvals (Supplemental materials available at doi:10.12788/fp.0585).

0525FED-AVAHO-RAD_T20525FED-AVAHO-RAD_F40525FED-AVAHO-RAD_F5

Every consultation charge was reviewed. A typical patient following the standard pathway (eAppendix 2, available at doi:10.12788/ fp.0585) exhibited a predictable pattern of consultation payment, simulation and planning, multiple radiation treatments interspersed with treatment management visits and a cone-down phase, and finishing with a follow-up visit. A less predictable case with excess CPT codes, gaps in charges, and an additional unexpected palliative course is shown in eAppendix 3 (available at doi:10.12788/fp.0585). Gaps occurred in 42% of SEOCs with missed bills costing as much as $12,000. For example, a patient with lung cancer had a treatment summary note for lung cancer after completion that showed the patient received 30 fractions of 2 Gy, a typical course. Only 10 treatment codes and 3 of 6 weekly treatment management codes were available. There was a gap of 20 volumetric modulated arc therapy treatments, 3 physics weekly status checks, 3 physician managements notes, and a computed tomography simulation charge.

0525FED-AVAHO-RAD_eApp20525FED-AVAHO-RAD_eApp3

Between AMCMS and CTM, 10,005 CPT codes were evaluated; 1255 (12.5%) were unique to AMCMS (either related to the radiation oncology course, such as Evaluation and Management CPT codes or “other” unrelated codes) while 1158 (11.6%) were unique to CTM. Of the 7592 CPT codes shared between AMCMS and CTM, there was a discrepancy in 135 (1.8%); all were duplicates (CTM showed double payment while AMCMS showed $0 paid). The total CPT code costs came to $3.2 million with $560,000 unique to SEOCs and $500,000 unique to CTM. Treatment codes were the most common (33%) as shown in Table 3 and accounted for 55% of the cost ($1.8 million). About 700 CPT codes were considered “other,” typically for biologic therapeutic agents (Table 4 and eAppendix 4, available at doi:10.12788/fp.0585).

0525FED-AVAHO-RAD_T30525FED-AVAHO-RAD_T40525FED-AVAHO-RAD_eApp4

DISCUSSION

The current method of reporting radiation oncology costs used by VA is insufficient and misleading. Better data are needed to summarize purchased care costs to guide decisions about community care at the VA. Investigations into whether the extra costs for quality care (ie, expensive capital equipment, specialized staff, mandatory accreditations) are worthwhile if omitted at other facilities patients choose for their health care needs. No study has defined specialty care-specific costs by evaluating billing receipts from the CDW to answer the question. Kenamond et al highlight the need for radiation oncology for rural patients.11 Drive time was cited as the reason for community care referral for 97% of veterans, many of whom lived in rural locations. Of patients with rurality information who enrolled in community care, 57% came from rural or highly rural counties, and this ratio held for those who received full curative therapies. An executive administrator relying on AMCMS reports would see a median SEOC cost of $5000, but without ROS knowledge in coding, the administrator would miss many additional costs. For example, 2 patients who each had 5 SEOCs during the evaluated period, incurred a total cost of only $1800.

Additionally, an administrator could include miscategorized costs with significant ramifications. The 2 most expensive SEOCs were not typical radiation oncology treatments. A patient undergoing radium-223 dichloride therapy incurred charges exceeding $165,000, contributing disproportionately to the overall median cost analysis; this would normally be administered by the nuclear medicine department. Immunotherapy and chemotherapy are uniformly overseen by medical oncology services, but drug administration codes were still found in radiation oncology SEOCs. A patient (whose SEOC was discontinued but accrued charges) had an electrocardiogram interpretation for $8 as the SEOC cost; 3 other SEOCs continued to incur costs after being discontinued. There were 24 empty SEOCs for patients that had consults to the community, and 2 had notes stating treatment had been delivered yet there was no ROS costs or SEOC costs. Of the 268 encounters, 43% had some sort of billing irregularities (ie, missing treatment costs) that would be unlikely for a private practice to omit; it would be much more likely that the CDW miscategorized the payment despite confirmation of the 2 retrieval systems.

It would be inadvisable to make staffing decisions or forecast costs based on current SEOC reports without specialized curation. A simple yet effective improvement to the cost attribution process would be to restrict the analysis to encounters containing primary radiation treatment codes. This targeted approach allows more accurate identification of patients actively receiving radiation oncology treatment, while excluding those seen solely for consultations or follow-up visits. Implementing this refinement leads to a substantial increase in the median payment—from $5000 to $13,000—without requiring additional coding or data processing, thereby enhancing the accuracy of cost estimates with minimal effort.

Clarifying radiation oncology service costs requires addressing the time frame and services included, given laxity and interpretation of the SEOCs. VA community care departments have streamlined the reimbursement process at the expense of medical cost organization and accuracy; 86% of VA practitioners reported that ≥ 1 potential community health care partners had refused to work with the VA because of payment delays.12 Payments are contingent on correspondence from outside practices for community work. For radiation oncology, this includes the consultation but also critical radiation-related details of treatment, which were omitted nearly half the time. SEOC approval forms have many costly laboratory tests, imaging, and procedures that have little to do with radiation oncology cancer treatments but may be used in the workup and staging process; this creates noise when calculating radiation oncology fiscal cost.

The presumption that an episode of care equates to a completed radiation therapy course is incorrect; this occurs less than half of the time. An episode often refers to a return visit, or conversely, multiple treatment courses. As the patients’ medical homes are their VHA primary care practitioners, it would be particularly challenging to care for the patients without full treatment information, especially if adverse effects from therapy were to arise. As a tertiary specialty, radiation oncology does not seek out patients and are sent consultations from medical oncology, surgical, and medical oncologic specialties. Timesensitive processes such as workup, staging, and diagnosis often occur in parallel. This analysis revealed that patients see outside radiation oncologists prior to the VA. There are ≥ 100 patients who had radiation oncology codes without a radiation oncology SEOC or community care consultation, and in many cases, the consultation was placed after the patient was seen.

Given the lack of uniformity and standardization of patient traffic, the typical and expected pathways were insufficient to find the costs. Too many opportunities for errors and incorrect categorization of costs meant a different method would be necessary. Starting at the inception of the community care consult, only 1 diagnosis code can be entered. For patients with multiple diagnoses, one would not be able to tell what was treated without chart access. Radiation oncology consults come from primary and specialty care practitioners and nurses throughout the VA. Oftentimes, the referral would be solicited by the community radiation oncology clinic, diagnosing community specialty (ie, urology for a patient with prostate cancer), or indirectly from the patient through primary care. Many cases were retroactively approved as the veteran had already been consulted by the community care radiation oncologist. If the patient is drive-time eligible, it would be unlikely that they would leave and choose to return to the VA. There is no way for a facility VA service chief or administrator to mitigate VA community costs of care, especially as shown by the miscategorization of several codes. Database challenges exacerbate the issue: 1 patient changed her first and last name during this time frame, and 2 patients had the same name but different social security numbers. In order to strictly find costs between 2 discrete timepoints, 39 (15%) SEOCs were split and incomplete, and 6 SEOCs contained charges for 2 different patients. This was corrected, and all inadvertent charges were cancelled. Only 1 ICD code is allowed per community care consultation, so an investigation is required to find costs for patients with multiple sites of disease. Additionally, 5 of the patients marked for drive time were actually patients who received Gamma Knife and brachytherapy, services not available at the VA.

Hanks et al first attempted to calculate cost of radiation oncology services. External beam prostate cancer radiotherapy at 3 suburban California centers cost $6750 ($20,503 inflation adjusted) per patient before October 1984 and $5600 ($17,010 inflation adjusted) afterwards.13 According to the American Society for Radiation Oncology, Advocacy Radiation Oncology Case Rate Program Curative radiation courses should cost $20,000 to $30,000 and palliative courses should cost $10,000 to $15,000. These costs are consistent with totals demonstrated in this analysis and similar to the inflation-adjusted Hanks et al figures. Preliminary findings suggest that radiation treatment constituted more than half of the total expenditures, with a notable $4 million increase in adjusted cost compared to the Medicare rates, indicating significant variation. Direct comparisons with Medicaid or commercial payer rates remain unexplored.

Future Directions

During the study period, 201 patients received 186 courses of radiation therapy in the community, while 1014 patients were treated in-house for a total of 833 courses. A forthcoming analysis will directly compare the cost of in-house care with that of communitybased treatment, specifically breaking down expenditure differences by diagnosis. Future research should investigate strategies to align reimbursement with quality metrics, including the potential role of tertiary accreditation in incentivizing high-value care. Additional work is also warranted to assess patient out-ofpocket expenses across care settings and to benchmark VA reimbursement against Medicare, Medicaid, and private insurance rates. In any case, with the increasing possibility of fewer fractions for treatments such as stereotactic radiotherapy or palliative care therapy, there is a clear financial incentive to treat as frequently as allowed despite equal clinical outcomes.

CONCLUSIONS

Veterans increasingly choose to receive care closer to home if the option is available. In the VA iron triangle, cost comes at the expense of access but quantifying this has proved elusive in the cost accounting model currently used at the VA.1 The inclusion of all charges loosely associated with SEOCs significantly impairs the ability to conduct meaningful cost analyses. The current VA methodology not only introduces substantial noise into the data but also leads to a marked underestimation of the true cost of care delivered in community settings. Such misrepresentation risks driving policy decisions that could inappropriately reduce or eliminate in-house radiation oncology services. Categorizing costs effectively in the VA could assist in making managerial and administrative decisions and would prevent damaging service lines based on misleading or incorrect data. A system which differentiates between patients who have received any treatment codes vs those who have not would increase accuracy.

References
  1. Kissick W. Medicine’s Dilemmas: Infinite Needs Versus Finite Resources. 1st ed. Yale University Press; 1994.
  2. Albanese AP, Bope ET, Sanders KM, Bowman M. The VA MISSION Act of 2018: a potential game changer for rural GME expansion and veteran health care. J Rural Health. 2020;36(1):133-136. doi:10.1111/jrh.12360
  3. Office of Management and Budget (US). Budget of the United States Government, Fiscal Year 2025. Washington, DC: US Government Publishing Office; 2024. Available from: US Department of Veterans Affairs FY 2025 Budget Submission: Budget in Brief.
  4. US Department of Veterans Affairs. Veteran care claims. Accessed April 3, 2025. https://www.va.gov/COMMUNITYCARE/revenue-ops/Veteran-Care-Claims.asp
  5. US Centers for Medicare and Medicaid Services. Accessed April 3, 2025. Procedure price lookup https://www.medicare.gov/procedure-price-lookup
  6. US Department of Veterans Affairs. WellHive -Enterprise. Accessed April 3, 2025. https://department.va.gov/privacy/wp-content/uploads/sites/5/2023/05/FY23WellHiveEnterprisePIA.pdf
  7. US Centers for Medicare and Medicaid Services. RVU21a physician fee schedule, January 2021 release. Accessed April 3, 2025. https://www.cms.gov/medicaremedicare-fee-service-paymentphysicianfeeschedpfs-relative-value-files/rvu21a
  8. US Centers for Medicare and Medicaid Services. RVU22a physician fee schedule, January 2022 release. Accessed April 3, 2025. https://www.cms.gov/medicaremedicare-fee-service-paymentphysicianfeeschedpfs-relative-value-files/rvu22a
  9. US Centers for Medicare and Medicaid Services. RVU23a physician fee schedule, January 2023 release. Accessed April 3, 2025. https://www.cms.gov/medicare/medicare-fee-service-payment/physicianfeesched/pfs-relative-value-files/rvu23a
  10. US Centers for Medicare and Medicaid Services. RVU23a Medicare Physician Fee Schedule rates effective January 1, 2024, through March 8, 2024. Accessed on April 3, 2025. https://www.cms.gov/medicare/payment/fee-schedules/physician/pfs-relative-value-files/rvu24a
  11. Kenamond MC, Mourad WF, Randall ME, Kaushal A. No oncology patient left behind: challenges and solutions in rural radiation oncology. Lancet Reg Health Am. 2022;13:100289. doi:10.1016/j.lana.2022.100289
  12. Mattocks KM, Kroll-Desrosiers A, Kinney R, Elwy AR, Cunningham KJ, Mengeling MA. Understanding VA’s use of and relationships with community care providers under the MISSION Act. Med Care. 2021;59(Suppl 3):S252-S258. doi:10.1097/MLR.0000000000001545
  13. Hanks GE, Dunlap K. A comparison of the cost of various treatment methods for early cancer of the prostate. Int J Radiat Oncol Biol Phys. 1986;12(10):1879-1881. doi:10.1016/0360-3016(86)90334-2
  14. American Society of Radiation Oncology. Radiation oncology case rate program (ROCR). Accessed April 3, 2025. https://www.astro.org/advocacy/key-issues-8f3e5a3b76643265ee93287d79c4fc40/rocr
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Ronald H. Shapiro, MD, MBAa; Reid F. Thompson, MD, PhDb,c; David A. Elliott, MDd,e,f; Christopher N. Watson, MDa; Helen Fosmire, MDa

Author affiliations
aRichard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana
bOregon Health & Science University, Portland
cVeterans Affairs Portland Health Care System, Oregon
dCharles S. Kettles Veterans Affairs Medical Center, Ann Arbor, Michigan
eUniversity of Michigan, Ann Arbor
fRogel Cancer Center, Ann Arbor, Michigan

Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Ronald Shapiro (ronald.shapiro@va.gov)

Fed Pract. 2025;42(suppl 2). Published online May 8. doi:10.12788/fp.0585

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Ronald H. Shapiro, MD, MBAa; Reid F. Thompson, MD, PhDb,c; David A. Elliott, MDd,e,f; Christopher N. Watson, MDa; Helen Fosmire, MDa

Author affiliations
aRichard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana
bOregon Health & Science University, Portland
cVeterans Affairs Portland Health Care System, Oregon
dCharles S. Kettles Veterans Affairs Medical Center, Ann Arbor, Michigan
eUniversity of Michigan, Ann Arbor
fRogel Cancer Center, Ann Arbor, Michigan

Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Ronald Shapiro (ronald.shapiro@va.gov)

Fed Pract. 2025;42(suppl 2). Published online May 8. doi:10.12788/fp.0585

Author and Disclosure Information

Ronald H. Shapiro, MD, MBAa; Reid F. Thompson, MD, PhDb,c; David A. Elliott, MDd,e,f; Christopher N. Watson, MDa; Helen Fosmire, MDa

Author affiliations
aRichard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana
bOregon Health & Science University, Portland
cVeterans Affairs Portland Health Care System, Oregon
dCharles S. Kettles Veterans Affairs Medical Center, Ann Arbor, Michigan
eUniversity of Michigan, Ann Arbor
fRogel Cancer Center, Ann Arbor, Michigan

Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Ronald Shapiro (ronald.shapiro@va.gov)

Fed Pract. 2025;42(suppl 2). Published online May 8. doi:10.12788/fp.0585

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William Kissick’s description of health care’s iron triangle in 1994 still resonates. Access, quality, and cost will always come at the expense of the others.1 In 2018, Congress passed the VA MISSION Act, allowing patients to pursue community care options for extended waits (> 28 days) or longer distance drive times of > 60 minutes for specialty care services, such as radiation oncology. According to Albanese et al, the VA MISSION Act sought to address gaps in care for veterans living in rural and underserved areas.2 The Veterans Health Administration (VHA) continues to increase community care spending, with a 13.8% increase in fiscal year 2024 and an expected cost of > $40 billion for 2025.3 One could argue this pays for access for remote patients and quality when services are unavailable, making it a direct application of the iron triangle.

The VA MISSION Act also bolstered the expansion of existing community care department staff to expediently facilitate and coordinate care and payments.2 Cost management and monitoring have become critical in predicting future staff requirements, maintaining functionality, and ensuring patients receive optimal care. The VHA purchases care through partner networks and defines these bundled health care services as standard episodes of care (SEOCs), which are “clinically related health care services for a specific unique illness or medical condition… over a defined period of time.”4 Medicare publishes its rates quarterly, and outpatient procedure pricing is readily available online.5 Along these same lines, the US Department of Veterans Affairs (VA) publishes a current list of available procedures and associated Current Procedure Technology (CPT) codes that are covered under its VA fee schedule for community care.

Unique challenges persist when using this system to accurately account for radiation oncology expenditures. This study was based on the current practices at the Richard L. Roudebush VA Medical Center (RLRVAMC), a large 1a hospital. A detailed analysis reveals the contemporaneous cost of radiation oncology cancer care from October 1, 2021, through February 1, 2024, highlights the challenges in SEOC definition and duration, communication issues between RLRVAMC and purchase partners, inconsistencies in billing, erroneous payments, and difficulty of cost categorization.

METHODS

Community care radiation oncology-related costs were examined from October 1, 2021, to February 1, 2024 for RLRVAMC, 6 months prior to billing data extraction. Figure 1 shows a simple radiation oncology patient pathway with consultation or visit, simulation and planning, and treatment, with codes used to check billing. It illustrates the expected relationships between the VHA (radiation oncology, primary, and specialty care) and community care (clinicians and radiation oncology treatment sites).

0525FED-AVAHO-RAD_F1

VHA standard operating procedures for a patient requesting community-based radiation oncology care require a board-certified radiation oncologist at RLRVAMC to review and approve the outside care request. Community care radiation oncology consultation data were accessed from the VA Corporate Data Warehouse (CDW) using Pyramid Analytics (V25.2). Nurses, physicians, and community care staff can add comments, forward consultations to other services, and mark them as complete or discontinued, when appropriate. Consultations not completed within 91 days are automatically discontinued. All community care requests from 2018 through 2024 were extracted; analysis began April 1, 2021, 6 months prior to the cost evaluation date of October 1, 2021.

An approved consultation is reviewed for eligibility by a nurse in the community care department and assigned an authorization number (a VA prefix followed by 12 digits). Billing codes are approved and organized by the community care networks, and all procedure codes should be captured and labeled under this number. The VAMC Community Care department obtains initial correspondence from the treating clinicians. Subsequent records from the treating radiation oncologist are expected to be scanned into the electronic health record and made accessible via the VA Joint Legacy Viewer (JLV) and Computerized Patient Record System (CPRS).

Radiation Oncology SEOC

The start date of the radiation oncology SEOC is determined by the community care nurse based on guidance established by the VA. It can be manually backdated or delayed, but current practice is to start at first visit or procedure code entry after approval from the VAMC Radiation Oncology department. Approved CPT codes from SEOC versions between October 1, 2021, and February 1, 2024, are in eAppendix 1 (available at doi:10.12788/fp.0585). These generally include 10 types of encounters, about 115 different laboratory tests, 115 imaging studies, 25 simulation and planning procedures, and 115 radiation treatment codes. The radiation oncology SEOCs during the study period had an approval duration of 180 days. Advanced Medical Cost Management Solutions software (AMCMS) is the VHA data analytics platform for community care medical service costs. AMCMS includes all individual CPT codes billed by specific radiation oncology SEOC versions. Data are refreshed monthly, and all charges were extracted on September 12, 2024, > 6 months after the final evaluated service date to allow for complete billing returns.6

0525FED-AVAHO-RAD_eApp1
Radiation Oncology-Specific Costs

The VA Close to Me (CTM) program was used to find 84 specific radiation oncology CPT codes, nearly all within the 77.XXX or G6.XXX series, which included all radiation oncology-specific (ROS) codes (except visits accrued during consultation and return appointments). ROS costs are those that could not be performed by any other service and include procedures related to radiation oncology simulation, treatment planning, treatment delivery (with or without image guidance), and physician or physicist management. All ROS costs should be included in a patient’s radiation oncology SEOC. Other costs that may accompany operating room or brachytherapy administration did not follow a 77.XXX or G6.XXX pattern but were included in total radiation therapy operating costs.

Data obtained from AMCMS and CTM included patient name and identifier; CPT billed amount; CPT paid amount; dates of service; number of claims; International Classification of Diseases, Tenth Revision (ICD) diagnosis; and VA authorization numbers. Only CTM listed code modifiers. Only items categorized as paid were included in the analysis. Charges associated with discontinued consultations that had accrued costs also were included. Codes that were not directly related to ROS were separately characterized as other and further subcategorized.

Deep Dive Categorization

All scanned documents tagged to the community consultation were accessed and evaluated for completeness by a radiation oncologist (RS). The presence or absence of consultation notes and treatment summaries was evaluated based on necessity (ie, not needed for continuation of care or treatment was not given). In the absence of a specific completion summary or follow-up note detailing the treatment modality, number of fractions, and treatment sites, available documentation, including clinical notes and billing information, was used. Radical or curative therapies were identified as courses expected to eradicate disease, including stereotactic ablative radiotherapy to the brain, lung, liver, and other organs. Palliative therapies included whole-brain radiotherapy or other low-dose treatments. If the patient received the intended course, this was categorized as full. If incomplete, it was considered partial.

Billing Deviations

The complete document review allowed for close evaluation of paid therapy and identification of gaps in billing (eg, charges not found in extracted data that should have occurred) for external beam radiotherapy patients. Conversely, extra charges, such as an additional weekly treatment management charge (CPT code 77427), would be noted. Patients were expected to have the number of treatments specified in the summary, a clinical treatment planning code, and weekly treatment management notes from physicians and physicists every 5 fractions. Consultations and follow-up visits were expected to have 1 visit code; CPT codes 99205 and 99215, respectively, were used to estimate costs in their absence.

Costs were based on Medicare rates as of January 1 of the year in which they were accrued. 7-10 Duplicates were charges with the same code, date, billed quantity, and paid amounts for a given patient. These would always be considered erroneous. Medicare treatment costs for procedures such as intensity modulated radiotherapy (CPT code 77385 or 77386) are available on the Medicare website. When reviewing locality deviations for 77427, there was a maximum of 33% increase in Medicare rates. Therefore, for treatment codes, one would expect the range to be at least the Medicare rate and maximally 33% higher. These rates are negotiated with insurance companies, but this range was used for the purpose of reviewing and adjusting large data sets.

RESULTS

Since 2018, > 500 community care consults have been placed by radiation oncology for treatment in the community, with more following implementation of the VA MISSION Act. Use of radiation oncology community care services annually increased during the study period for this facility (Table 1, Figure 2). Of the 325 community care consults placed from October 1, 2021, to February 1, 2024, 248 radiation oncology SEOCs were recorded with charges for 181 patients (range, 1-5 SEOCs). Long drive time was the rationale for > 97% of patients directed to community care (Supplemental materials, available at doi:10.12788/fp.0585). Based on AMCMS data, $22.2 million was billed and $2.7 million was paid (20%) for 8747 CPT codes. Each community care interval cost the VA a median (range) of $5000 ($8-$168,000 (Figure 3).

0525FED-AVAHO-RAD_T10525FED-AVAHO-RAD_F20525FED-AVAHO-RAD_F3

After reviewing ROS charges extracted from CTM, 20 additional patients had radiation oncology charges but did not have a radiation oncology SEOC for 268 episodes of care for 201 unique patients. In addition to the 20 patients who did not have a SEOC, 42 nonradiation oncology SEOCs contained 1148 radiation oncology codes, corresponding to almost $500,000 paid. Additional charges of about $416,000, which included biologic agents (eg, durvalumab, nivolumab), procedures (eg, mastectomies), and ambulance rides were inappropriately added to radiation oncology SEOCs.

While 77% of consultations were scanned into CPRS and JLV, only 54% of completion summaries were available with an estimated $115,000 in additional costs. The total adjusted costs was about $2.9 million. Almost 37% of SEOCs were for visits only. For the 166 SEOCs where patients received any radiation treatment or planning, the median cost was $18,000. Differences in SEOC pathways are shown in Figure 4. One hundred twenty-one SEOCs (45%) followed the standard pathway, with median SEOC costs of $15,500; when corrected for radiation-specific costs, the median cost increased to $18,000. When adjusted for billing irregularities, the median cost was $20,600. Ninety-nine SEOCs (37%) were for consultation/ follow-up visits only, with a median cost of $220. When omitting shared scans and nonradiation therapy costs and correcting for billing gaps, the median cost decreased to $170. A median of $9200 was paid per patient, with $12,900 for radiation therapy-specific costs and $13,300 adjusted for billing deviations. Narrowing to the 106 patients who received full, radical courses, the median SEOC, ROS, and adjusted radiation therapy costs increased to $19,400, $22,200, and $22,900, respectively (Table 2, Figure 5). Seventy-one SEOCs (26%) had already seen a radiation oncologist before the VA radiation oncology department was aware, and 49 SEOCs (18%) had retroactive approvals (Supplemental materials available at doi:10.12788/fp.0585).

0525FED-AVAHO-RAD_T20525FED-AVAHO-RAD_F40525FED-AVAHO-RAD_F5

Every consultation charge was reviewed. A typical patient following the standard pathway (eAppendix 2, available at doi:10.12788/ fp.0585) exhibited a predictable pattern of consultation payment, simulation and planning, multiple radiation treatments interspersed with treatment management visits and a cone-down phase, and finishing with a follow-up visit. A less predictable case with excess CPT codes, gaps in charges, and an additional unexpected palliative course is shown in eAppendix 3 (available at doi:10.12788/fp.0585). Gaps occurred in 42% of SEOCs with missed bills costing as much as $12,000. For example, a patient with lung cancer had a treatment summary note for lung cancer after completion that showed the patient received 30 fractions of 2 Gy, a typical course. Only 10 treatment codes and 3 of 6 weekly treatment management codes were available. There was a gap of 20 volumetric modulated arc therapy treatments, 3 physics weekly status checks, 3 physician managements notes, and a computed tomography simulation charge.

0525FED-AVAHO-RAD_eApp20525FED-AVAHO-RAD_eApp3

Between AMCMS and CTM, 10,005 CPT codes were evaluated; 1255 (12.5%) were unique to AMCMS (either related to the radiation oncology course, such as Evaluation and Management CPT codes or “other” unrelated codes) while 1158 (11.6%) were unique to CTM. Of the 7592 CPT codes shared between AMCMS and CTM, there was a discrepancy in 135 (1.8%); all were duplicates (CTM showed double payment while AMCMS showed $0 paid). The total CPT code costs came to $3.2 million with $560,000 unique to SEOCs and $500,000 unique to CTM. Treatment codes were the most common (33%) as shown in Table 3 and accounted for 55% of the cost ($1.8 million). About 700 CPT codes were considered “other,” typically for biologic therapeutic agents (Table 4 and eAppendix 4, available at doi:10.12788/fp.0585).

0525FED-AVAHO-RAD_T30525FED-AVAHO-RAD_T40525FED-AVAHO-RAD_eApp4

DISCUSSION

The current method of reporting radiation oncology costs used by VA is insufficient and misleading. Better data are needed to summarize purchased care costs to guide decisions about community care at the VA. Investigations into whether the extra costs for quality care (ie, expensive capital equipment, specialized staff, mandatory accreditations) are worthwhile if omitted at other facilities patients choose for their health care needs. No study has defined specialty care-specific costs by evaluating billing receipts from the CDW to answer the question. Kenamond et al highlight the need for radiation oncology for rural patients.11 Drive time was cited as the reason for community care referral for 97% of veterans, many of whom lived in rural locations. Of patients with rurality information who enrolled in community care, 57% came from rural or highly rural counties, and this ratio held for those who received full curative therapies. An executive administrator relying on AMCMS reports would see a median SEOC cost of $5000, but without ROS knowledge in coding, the administrator would miss many additional costs. For example, 2 patients who each had 5 SEOCs during the evaluated period, incurred a total cost of only $1800.

Additionally, an administrator could include miscategorized costs with significant ramifications. The 2 most expensive SEOCs were not typical radiation oncology treatments. A patient undergoing radium-223 dichloride therapy incurred charges exceeding $165,000, contributing disproportionately to the overall median cost analysis; this would normally be administered by the nuclear medicine department. Immunotherapy and chemotherapy are uniformly overseen by medical oncology services, but drug administration codes were still found in radiation oncology SEOCs. A patient (whose SEOC was discontinued but accrued charges) had an electrocardiogram interpretation for $8 as the SEOC cost; 3 other SEOCs continued to incur costs after being discontinued. There were 24 empty SEOCs for patients that had consults to the community, and 2 had notes stating treatment had been delivered yet there was no ROS costs or SEOC costs. Of the 268 encounters, 43% had some sort of billing irregularities (ie, missing treatment costs) that would be unlikely for a private practice to omit; it would be much more likely that the CDW miscategorized the payment despite confirmation of the 2 retrieval systems.

It would be inadvisable to make staffing decisions or forecast costs based on current SEOC reports without specialized curation. A simple yet effective improvement to the cost attribution process would be to restrict the analysis to encounters containing primary radiation treatment codes. This targeted approach allows more accurate identification of patients actively receiving radiation oncology treatment, while excluding those seen solely for consultations or follow-up visits. Implementing this refinement leads to a substantial increase in the median payment—from $5000 to $13,000—without requiring additional coding or data processing, thereby enhancing the accuracy of cost estimates with minimal effort.

Clarifying radiation oncology service costs requires addressing the time frame and services included, given laxity and interpretation of the SEOCs. VA community care departments have streamlined the reimbursement process at the expense of medical cost organization and accuracy; 86% of VA practitioners reported that ≥ 1 potential community health care partners had refused to work with the VA because of payment delays.12 Payments are contingent on correspondence from outside practices for community work. For radiation oncology, this includes the consultation but also critical radiation-related details of treatment, which were omitted nearly half the time. SEOC approval forms have many costly laboratory tests, imaging, and procedures that have little to do with radiation oncology cancer treatments but may be used in the workup and staging process; this creates noise when calculating radiation oncology fiscal cost.

The presumption that an episode of care equates to a completed radiation therapy course is incorrect; this occurs less than half of the time. An episode often refers to a return visit, or conversely, multiple treatment courses. As the patients’ medical homes are their VHA primary care practitioners, it would be particularly challenging to care for the patients without full treatment information, especially if adverse effects from therapy were to arise. As a tertiary specialty, radiation oncology does not seek out patients and are sent consultations from medical oncology, surgical, and medical oncologic specialties. Timesensitive processes such as workup, staging, and diagnosis often occur in parallel. This analysis revealed that patients see outside radiation oncologists prior to the VA. There are ≥ 100 patients who had radiation oncology codes without a radiation oncology SEOC or community care consultation, and in many cases, the consultation was placed after the patient was seen.

Given the lack of uniformity and standardization of patient traffic, the typical and expected pathways were insufficient to find the costs. Too many opportunities for errors and incorrect categorization of costs meant a different method would be necessary. Starting at the inception of the community care consult, only 1 diagnosis code can be entered. For patients with multiple diagnoses, one would not be able to tell what was treated without chart access. Radiation oncology consults come from primary and specialty care practitioners and nurses throughout the VA. Oftentimes, the referral would be solicited by the community radiation oncology clinic, diagnosing community specialty (ie, urology for a patient with prostate cancer), or indirectly from the patient through primary care. Many cases were retroactively approved as the veteran had already been consulted by the community care radiation oncologist. If the patient is drive-time eligible, it would be unlikely that they would leave and choose to return to the VA. There is no way for a facility VA service chief or administrator to mitigate VA community costs of care, especially as shown by the miscategorization of several codes. Database challenges exacerbate the issue: 1 patient changed her first and last name during this time frame, and 2 patients had the same name but different social security numbers. In order to strictly find costs between 2 discrete timepoints, 39 (15%) SEOCs were split and incomplete, and 6 SEOCs contained charges for 2 different patients. This was corrected, and all inadvertent charges were cancelled. Only 1 ICD code is allowed per community care consultation, so an investigation is required to find costs for patients with multiple sites of disease. Additionally, 5 of the patients marked for drive time were actually patients who received Gamma Knife and brachytherapy, services not available at the VA.

Hanks et al first attempted to calculate cost of radiation oncology services. External beam prostate cancer radiotherapy at 3 suburban California centers cost $6750 ($20,503 inflation adjusted) per patient before October 1984 and $5600 ($17,010 inflation adjusted) afterwards.13 According to the American Society for Radiation Oncology, Advocacy Radiation Oncology Case Rate Program Curative radiation courses should cost $20,000 to $30,000 and palliative courses should cost $10,000 to $15,000. These costs are consistent with totals demonstrated in this analysis and similar to the inflation-adjusted Hanks et al figures. Preliminary findings suggest that radiation treatment constituted more than half of the total expenditures, with a notable $4 million increase in adjusted cost compared to the Medicare rates, indicating significant variation. Direct comparisons with Medicaid or commercial payer rates remain unexplored.

Future Directions

During the study period, 201 patients received 186 courses of radiation therapy in the community, while 1014 patients were treated in-house for a total of 833 courses. A forthcoming analysis will directly compare the cost of in-house care with that of communitybased treatment, specifically breaking down expenditure differences by diagnosis. Future research should investigate strategies to align reimbursement with quality metrics, including the potential role of tertiary accreditation in incentivizing high-value care. Additional work is also warranted to assess patient out-ofpocket expenses across care settings and to benchmark VA reimbursement against Medicare, Medicaid, and private insurance rates. In any case, with the increasing possibility of fewer fractions for treatments such as stereotactic radiotherapy or palliative care therapy, there is a clear financial incentive to treat as frequently as allowed despite equal clinical outcomes.

CONCLUSIONS

Veterans increasingly choose to receive care closer to home if the option is available. In the VA iron triangle, cost comes at the expense of access but quantifying this has proved elusive in the cost accounting model currently used at the VA.1 The inclusion of all charges loosely associated with SEOCs significantly impairs the ability to conduct meaningful cost analyses. The current VA methodology not only introduces substantial noise into the data but also leads to a marked underestimation of the true cost of care delivered in community settings. Such misrepresentation risks driving policy decisions that could inappropriately reduce or eliminate in-house radiation oncology services. Categorizing costs effectively in the VA could assist in making managerial and administrative decisions and would prevent damaging service lines based on misleading or incorrect data. A system which differentiates between patients who have received any treatment codes vs those who have not would increase accuracy.

William Kissick’s description of health care’s iron triangle in 1994 still resonates. Access, quality, and cost will always come at the expense of the others.1 In 2018, Congress passed the VA MISSION Act, allowing patients to pursue community care options for extended waits (> 28 days) or longer distance drive times of > 60 minutes for specialty care services, such as radiation oncology. According to Albanese et al, the VA MISSION Act sought to address gaps in care for veterans living in rural and underserved areas.2 The Veterans Health Administration (VHA) continues to increase community care spending, with a 13.8% increase in fiscal year 2024 and an expected cost of > $40 billion for 2025.3 One could argue this pays for access for remote patients and quality when services are unavailable, making it a direct application of the iron triangle.

The VA MISSION Act also bolstered the expansion of existing community care department staff to expediently facilitate and coordinate care and payments.2 Cost management and monitoring have become critical in predicting future staff requirements, maintaining functionality, and ensuring patients receive optimal care. The VHA purchases care through partner networks and defines these bundled health care services as standard episodes of care (SEOCs), which are “clinically related health care services for a specific unique illness or medical condition… over a defined period of time.”4 Medicare publishes its rates quarterly, and outpatient procedure pricing is readily available online.5 Along these same lines, the US Department of Veterans Affairs (VA) publishes a current list of available procedures and associated Current Procedure Technology (CPT) codes that are covered under its VA fee schedule for community care.

Unique challenges persist when using this system to accurately account for radiation oncology expenditures. This study was based on the current practices at the Richard L. Roudebush VA Medical Center (RLRVAMC), a large 1a hospital. A detailed analysis reveals the contemporaneous cost of radiation oncology cancer care from October 1, 2021, through February 1, 2024, highlights the challenges in SEOC definition and duration, communication issues between RLRVAMC and purchase partners, inconsistencies in billing, erroneous payments, and difficulty of cost categorization.

METHODS

Community care radiation oncology-related costs were examined from October 1, 2021, to February 1, 2024 for RLRVAMC, 6 months prior to billing data extraction. Figure 1 shows a simple radiation oncology patient pathway with consultation or visit, simulation and planning, and treatment, with codes used to check billing. It illustrates the expected relationships between the VHA (radiation oncology, primary, and specialty care) and community care (clinicians and radiation oncology treatment sites).

0525FED-AVAHO-RAD_F1

VHA standard operating procedures for a patient requesting community-based radiation oncology care require a board-certified radiation oncologist at RLRVAMC to review and approve the outside care request. Community care radiation oncology consultation data were accessed from the VA Corporate Data Warehouse (CDW) using Pyramid Analytics (V25.2). Nurses, physicians, and community care staff can add comments, forward consultations to other services, and mark them as complete or discontinued, when appropriate. Consultations not completed within 91 days are automatically discontinued. All community care requests from 2018 through 2024 were extracted; analysis began April 1, 2021, 6 months prior to the cost evaluation date of October 1, 2021.

An approved consultation is reviewed for eligibility by a nurse in the community care department and assigned an authorization number (a VA prefix followed by 12 digits). Billing codes are approved and organized by the community care networks, and all procedure codes should be captured and labeled under this number. The VAMC Community Care department obtains initial correspondence from the treating clinicians. Subsequent records from the treating radiation oncologist are expected to be scanned into the electronic health record and made accessible via the VA Joint Legacy Viewer (JLV) and Computerized Patient Record System (CPRS).

Radiation Oncology SEOC

The start date of the radiation oncology SEOC is determined by the community care nurse based on guidance established by the VA. It can be manually backdated or delayed, but current practice is to start at first visit or procedure code entry after approval from the VAMC Radiation Oncology department. Approved CPT codes from SEOC versions between October 1, 2021, and February 1, 2024, are in eAppendix 1 (available at doi:10.12788/fp.0585). These generally include 10 types of encounters, about 115 different laboratory tests, 115 imaging studies, 25 simulation and planning procedures, and 115 radiation treatment codes. The radiation oncology SEOCs during the study period had an approval duration of 180 days. Advanced Medical Cost Management Solutions software (AMCMS) is the VHA data analytics platform for community care medical service costs. AMCMS includes all individual CPT codes billed by specific radiation oncology SEOC versions. Data are refreshed monthly, and all charges were extracted on September 12, 2024, > 6 months after the final evaluated service date to allow for complete billing returns.6

0525FED-AVAHO-RAD_eApp1
Radiation Oncology-Specific Costs

The VA Close to Me (CTM) program was used to find 84 specific radiation oncology CPT codes, nearly all within the 77.XXX or G6.XXX series, which included all radiation oncology-specific (ROS) codes (except visits accrued during consultation and return appointments). ROS costs are those that could not be performed by any other service and include procedures related to radiation oncology simulation, treatment planning, treatment delivery (with or without image guidance), and physician or physicist management. All ROS costs should be included in a patient’s radiation oncology SEOC. Other costs that may accompany operating room or brachytherapy administration did not follow a 77.XXX or G6.XXX pattern but were included in total radiation therapy operating costs.

Data obtained from AMCMS and CTM included patient name and identifier; CPT billed amount; CPT paid amount; dates of service; number of claims; International Classification of Diseases, Tenth Revision (ICD) diagnosis; and VA authorization numbers. Only CTM listed code modifiers. Only items categorized as paid were included in the analysis. Charges associated with discontinued consultations that had accrued costs also were included. Codes that were not directly related to ROS were separately characterized as other and further subcategorized.

Deep Dive Categorization

All scanned documents tagged to the community consultation were accessed and evaluated for completeness by a radiation oncologist (RS). The presence or absence of consultation notes and treatment summaries was evaluated based on necessity (ie, not needed for continuation of care or treatment was not given). In the absence of a specific completion summary or follow-up note detailing the treatment modality, number of fractions, and treatment sites, available documentation, including clinical notes and billing information, was used. Radical or curative therapies were identified as courses expected to eradicate disease, including stereotactic ablative radiotherapy to the brain, lung, liver, and other organs. Palliative therapies included whole-brain radiotherapy or other low-dose treatments. If the patient received the intended course, this was categorized as full. If incomplete, it was considered partial.

Billing Deviations

The complete document review allowed for close evaluation of paid therapy and identification of gaps in billing (eg, charges not found in extracted data that should have occurred) for external beam radiotherapy patients. Conversely, extra charges, such as an additional weekly treatment management charge (CPT code 77427), would be noted. Patients were expected to have the number of treatments specified in the summary, a clinical treatment planning code, and weekly treatment management notes from physicians and physicists every 5 fractions. Consultations and follow-up visits were expected to have 1 visit code; CPT codes 99205 and 99215, respectively, were used to estimate costs in their absence.

Costs were based on Medicare rates as of January 1 of the year in which they were accrued. 7-10 Duplicates were charges with the same code, date, billed quantity, and paid amounts for a given patient. These would always be considered erroneous. Medicare treatment costs for procedures such as intensity modulated radiotherapy (CPT code 77385 or 77386) are available on the Medicare website. When reviewing locality deviations for 77427, there was a maximum of 33% increase in Medicare rates. Therefore, for treatment codes, one would expect the range to be at least the Medicare rate and maximally 33% higher. These rates are negotiated with insurance companies, but this range was used for the purpose of reviewing and adjusting large data sets.

RESULTS

Since 2018, > 500 community care consults have been placed by radiation oncology for treatment in the community, with more following implementation of the VA MISSION Act. Use of radiation oncology community care services annually increased during the study period for this facility (Table 1, Figure 2). Of the 325 community care consults placed from October 1, 2021, to February 1, 2024, 248 radiation oncology SEOCs were recorded with charges for 181 patients (range, 1-5 SEOCs). Long drive time was the rationale for > 97% of patients directed to community care (Supplemental materials, available at doi:10.12788/fp.0585). Based on AMCMS data, $22.2 million was billed and $2.7 million was paid (20%) for 8747 CPT codes. Each community care interval cost the VA a median (range) of $5000 ($8-$168,000 (Figure 3).

0525FED-AVAHO-RAD_T10525FED-AVAHO-RAD_F20525FED-AVAHO-RAD_F3

After reviewing ROS charges extracted from CTM, 20 additional patients had radiation oncology charges but did not have a radiation oncology SEOC for 268 episodes of care for 201 unique patients. In addition to the 20 patients who did not have a SEOC, 42 nonradiation oncology SEOCs contained 1148 radiation oncology codes, corresponding to almost $500,000 paid. Additional charges of about $416,000, which included biologic agents (eg, durvalumab, nivolumab), procedures (eg, mastectomies), and ambulance rides were inappropriately added to radiation oncology SEOCs.

While 77% of consultations were scanned into CPRS and JLV, only 54% of completion summaries were available with an estimated $115,000 in additional costs. The total adjusted costs was about $2.9 million. Almost 37% of SEOCs were for visits only. For the 166 SEOCs where patients received any radiation treatment or planning, the median cost was $18,000. Differences in SEOC pathways are shown in Figure 4. One hundred twenty-one SEOCs (45%) followed the standard pathway, with median SEOC costs of $15,500; when corrected for radiation-specific costs, the median cost increased to $18,000. When adjusted for billing irregularities, the median cost was $20,600. Ninety-nine SEOCs (37%) were for consultation/ follow-up visits only, with a median cost of $220. When omitting shared scans and nonradiation therapy costs and correcting for billing gaps, the median cost decreased to $170. A median of $9200 was paid per patient, with $12,900 for radiation therapy-specific costs and $13,300 adjusted for billing deviations. Narrowing to the 106 patients who received full, radical courses, the median SEOC, ROS, and adjusted radiation therapy costs increased to $19,400, $22,200, and $22,900, respectively (Table 2, Figure 5). Seventy-one SEOCs (26%) had already seen a radiation oncologist before the VA radiation oncology department was aware, and 49 SEOCs (18%) had retroactive approvals (Supplemental materials available at doi:10.12788/fp.0585).

0525FED-AVAHO-RAD_T20525FED-AVAHO-RAD_F40525FED-AVAHO-RAD_F5

Every consultation charge was reviewed. A typical patient following the standard pathway (eAppendix 2, available at doi:10.12788/ fp.0585) exhibited a predictable pattern of consultation payment, simulation and planning, multiple radiation treatments interspersed with treatment management visits and a cone-down phase, and finishing with a follow-up visit. A less predictable case with excess CPT codes, gaps in charges, and an additional unexpected palliative course is shown in eAppendix 3 (available at doi:10.12788/fp.0585). Gaps occurred in 42% of SEOCs with missed bills costing as much as $12,000. For example, a patient with lung cancer had a treatment summary note for lung cancer after completion that showed the patient received 30 fractions of 2 Gy, a typical course. Only 10 treatment codes and 3 of 6 weekly treatment management codes were available. There was a gap of 20 volumetric modulated arc therapy treatments, 3 physics weekly status checks, 3 physician managements notes, and a computed tomography simulation charge.

0525FED-AVAHO-RAD_eApp20525FED-AVAHO-RAD_eApp3

Between AMCMS and CTM, 10,005 CPT codes were evaluated; 1255 (12.5%) were unique to AMCMS (either related to the radiation oncology course, such as Evaluation and Management CPT codes or “other” unrelated codes) while 1158 (11.6%) were unique to CTM. Of the 7592 CPT codes shared between AMCMS and CTM, there was a discrepancy in 135 (1.8%); all were duplicates (CTM showed double payment while AMCMS showed $0 paid). The total CPT code costs came to $3.2 million with $560,000 unique to SEOCs and $500,000 unique to CTM. Treatment codes were the most common (33%) as shown in Table 3 and accounted for 55% of the cost ($1.8 million). About 700 CPT codes were considered “other,” typically for biologic therapeutic agents (Table 4 and eAppendix 4, available at doi:10.12788/fp.0585).

0525FED-AVAHO-RAD_T30525FED-AVAHO-RAD_T40525FED-AVAHO-RAD_eApp4

DISCUSSION

The current method of reporting radiation oncology costs used by VA is insufficient and misleading. Better data are needed to summarize purchased care costs to guide decisions about community care at the VA. Investigations into whether the extra costs for quality care (ie, expensive capital equipment, specialized staff, mandatory accreditations) are worthwhile if omitted at other facilities patients choose for their health care needs. No study has defined specialty care-specific costs by evaluating billing receipts from the CDW to answer the question. Kenamond et al highlight the need for radiation oncology for rural patients.11 Drive time was cited as the reason for community care referral for 97% of veterans, many of whom lived in rural locations. Of patients with rurality information who enrolled in community care, 57% came from rural or highly rural counties, and this ratio held for those who received full curative therapies. An executive administrator relying on AMCMS reports would see a median SEOC cost of $5000, but without ROS knowledge in coding, the administrator would miss many additional costs. For example, 2 patients who each had 5 SEOCs during the evaluated period, incurred a total cost of only $1800.

Additionally, an administrator could include miscategorized costs with significant ramifications. The 2 most expensive SEOCs were not typical radiation oncology treatments. A patient undergoing radium-223 dichloride therapy incurred charges exceeding $165,000, contributing disproportionately to the overall median cost analysis; this would normally be administered by the nuclear medicine department. Immunotherapy and chemotherapy are uniformly overseen by medical oncology services, but drug administration codes were still found in radiation oncology SEOCs. A patient (whose SEOC was discontinued but accrued charges) had an electrocardiogram interpretation for $8 as the SEOC cost; 3 other SEOCs continued to incur costs after being discontinued. There were 24 empty SEOCs for patients that had consults to the community, and 2 had notes stating treatment had been delivered yet there was no ROS costs or SEOC costs. Of the 268 encounters, 43% had some sort of billing irregularities (ie, missing treatment costs) that would be unlikely for a private practice to omit; it would be much more likely that the CDW miscategorized the payment despite confirmation of the 2 retrieval systems.

It would be inadvisable to make staffing decisions or forecast costs based on current SEOC reports without specialized curation. A simple yet effective improvement to the cost attribution process would be to restrict the analysis to encounters containing primary radiation treatment codes. This targeted approach allows more accurate identification of patients actively receiving radiation oncology treatment, while excluding those seen solely for consultations or follow-up visits. Implementing this refinement leads to a substantial increase in the median payment—from $5000 to $13,000—without requiring additional coding or data processing, thereby enhancing the accuracy of cost estimates with minimal effort.

Clarifying radiation oncology service costs requires addressing the time frame and services included, given laxity and interpretation of the SEOCs. VA community care departments have streamlined the reimbursement process at the expense of medical cost organization and accuracy; 86% of VA practitioners reported that ≥ 1 potential community health care partners had refused to work with the VA because of payment delays.12 Payments are contingent on correspondence from outside practices for community work. For radiation oncology, this includes the consultation but also critical radiation-related details of treatment, which were omitted nearly half the time. SEOC approval forms have many costly laboratory tests, imaging, and procedures that have little to do with radiation oncology cancer treatments but may be used in the workup and staging process; this creates noise when calculating radiation oncology fiscal cost.

The presumption that an episode of care equates to a completed radiation therapy course is incorrect; this occurs less than half of the time. An episode often refers to a return visit, or conversely, multiple treatment courses. As the patients’ medical homes are their VHA primary care practitioners, it would be particularly challenging to care for the patients without full treatment information, especially if adverse effects from therapy were to arise. As a tertiary specialty, radiation oncology does not seek out patients and are sent consultations from medical oncology, surgical, and medical oncologic specialties. Timesensitive processes such as workup, staging, and diagnosis often occur in parallel. This analysis revealed that patients see outside radiation oncologists prior to the VA. There are ≥ 100 patients who had radiation oncology codes without a radiation oncology SEOC or community care consultation, and in many cases, the consultation was placed after the patient was seen.

Given the lack of uniformity and standardization of patient traffic, the typical and expected pathways were insufficient to find the costs. Too many opportunities for errors and incorrect categorization of costs meant a different method would be necessary. Starting at the inception of the community care consult, only 1 diagnosis code can be entered. For patients with multiple diagnoses, one would not be able to tell what was treated without chart access. Radiation oncology consults come from primary and specialty care practitioners and nurses throughout the VA. Oftentimes, the referral would be solicited by the community radiation oncology clinic, diagnosing community specialty (ie, urology for a patient with prostate cancer), or indirectly from the patient through primary care. Many cases were retroactively approved as the veteran had already been consulted by the community care radiation oncologist. If the patient is drive-time eligible, it would be unlikely that they would leave and choose to return to the VA. There is no way for a facility VA service chief or administrator to mitigate VA community costs of care, especially as shown by the miscategorization of several codes. Database challenges exacerbate the issue: 1 patient changed her first and last name during this time frame, and 2 patients had the same name but different social security numbers. In order to strictly find costs between 2 discrete timepoints, 39 (15%) SEOCs were split and incomplete, and 6 SEOCs contained charges for 2 different patients. This was corrected, and all inadvertent charges were cancelled. Only 1 ICD code is allowed per community care consultation, so an investigation is required to find costs for patients with multiple sites of disease. Additionally, 5 of the patients marked for drive time were actually patients who received Gamma Knife and brachytherapy, services not available at the VA.

Hanks et al first attempted to calculate cost of radiation oncology services. External beam prostate cancer radiotherapy at 3 suburban California centers cost $6750 ($20,503 inflation adjusted) per patient before October 1984 and $5600 ($17,010 inflation adjusted) afterwards.13 According to the American Society for Radiation Oncology, Advocacy Radiation Oncology Case Rate Program Curative radiation courses should cost $20,000 to $30,000 and palliative courses should cost $10,000 to $15,000. These costs are consistent with totals demonstrated in this analysis and similar to the inflation-adjusted Hanks et al figures. Preliminary findings suggest that radiation treatment constituted more than half of the total expenditures, with a notable $4 million increase in adjusted cost compared to the Medicare rates, indicating significant variation. Direct comparisons with Medicaid or commercial payer rates remain unexplored.

Future Directions

During the study period, 201 patients received 186 courses of radiation therapy in the community, while 1014 patients were treated in-house for a total of 833 courses. A forthcoming analysis will directly compare the cost of in-house care with that of communitybased treatment, specifically breaking down expenditure differences by diagnosis. Future research should investigate strategies to align reimbursement with quality metrics, including the potential role of tertiary accreditation in incentivizing high-value care. Additional work is also warranted to assess patient out-ofpocket expenses across care settings and to benchmark VA reimbursement against Medicare, Medicaid, and private insurance rates. In any case, with the increasing possibility of fewer fractions for treatments such as stereotactic radiotherapy or palliative care therapy, there is a clear financial incentive to treat as frequently as allowed despite equal clinical outcomes.

CONCLUSIONS

Veterans increasingly choose to receive care closer to home if the option is available. In the VA iron triangle, cost comes at the expense of access but quantifying this has proved elusive in the cost accounting model currently used at the VA.1 The inclusion of all charges loosely associated with SEOCs significantly impairs the ability to conduct meaningful cost analyses. The current VA methodology not only introduces substantial noise into the data but also leads to a marked underestimation of the true cost of care delivered in community settings. Such misrepresentation risks driving policy decisions that could inappropriately reduce or eliminate in-house radiation oncology services. Categorizing costs effectively in the VA could assist in making managerial and administrative decisions and would prevent damaging service lines based on misleading or incorrect data. A system which differentiates between patients who have received any treatment codes vs those who have not would increase accuracy.

References
  1. Kissick W. Medicine’s Dilemmas: Infinite Needs Versus Finite Resources. 1st ed. Yale University Press; 1994.
  2. Albanese AP, Bope ET, Sanders KM, Bowman M. The VA MISSION Act of 2018: a potential game changer for rural GME expansion and veteran health care. J Rural Health. 2020;36(1):133-136. doi:10.1111/jrh.12360
  3. Office of Management and Budget (US). Budget of the United States Government, Fiscal Year 2025. Washington, DC: US Government Publishing Office; 2024. Available from: US Department of Veterans Affairs FY 2025 Budget Submission: Budget in Brief.
  4. US Department of Veterans Affairs. Veteran care claims. Accessed April 3, 2025. https://www.va.gov/COMMUNITYCARE/revenue-ops/Veteran-Care-Claims.asp
  5. US Centers for Medicare and Medicaid Services. Accessed April 3, 2025. Procedure price lookup https://www.medicare.gov/procedure-price-lookup
  6. US Department of Veterans Affairs. WellHive -Enterprise. Accessed April 3, 2025. https://department.va.gov/privacy/wp-content/uploads/sites/5/2023/05/FY23WellHiveEnterprisePIA.pdf
  7. US Centers for Medicare and Medicaid Services. RVU21a physician fee schedule, January 2021 release. Accessed April 3, 2025. https://www.cms.gov/medicaremedicare-fee-service-paymentphysicianfeeschedpfs-relative-value-files/rvu21a
  8. US Centers for Medicare and Medicaid Services. RVU22a physician fee schedule, January 2022 release. Accessed April 3, 2025. https://www.cms.gov/medicaremedicare-fee-service-paymentphysicianfeeschedpfs-relative-value-files/rvu22a
  9. US Centers for Medicare and Medicaid Services. RVU23a physician fee schedule, January 2023 release. Accessed April 3, 2025. https://www.cms.gov/medicare/medicare-fee-service-payment/physicianfeesched/pfs-relative-value-files/rvu23a
  10. US Centers for Medicare and Medicaid Services. RVU23a Medicare Physician Fee Schedule rates effective January 1, 2024, through March 8, 2024. Accessed on April 3, 2025. https://www.cms.gov/medicare/payment/fee-schedules/physician/pfs-relative-value-files/rvu24a
  11. Kenamond MC, Mourad WF, Randall ME, Kaushal A. No oncology patient left behind: challenges and solutions in rural radiation oncology. Lancet Reg Health Am. 2022;13:100289. doi:10.1016/j.lana.2022.100289
  12. Mattocks KM, Kroll-Desrosiers A, Kinney R, Elwy AR, Cunningham KJ, Mengeling MA. Understanding VA’s use of and relationships with community care providers under the MISSION Act. Med Care. 2021;59(Suppl 3):S252-S258. doi:10.1097/MLR.0000000000001545
  13. Hanks GE, Dunlap K. A comparison of the cost of various treatment methods for early cancer of the prostate. Int J Radiat Oncol Biol Phys. 1986;12(10):1879-1881. doi:10.1016/0360-3016(86)90334-2
  14. American Society of Radiation Oncology. Radiation oncology case rate program (ROCR). Accessed April 3, 2025. https://www.astro.org/advocacy/key-issues-8f3e5a3b76643265ee93287d79c4fc40/rocr
References
  1. Kissick W. Medicine’s Dilemmas: Infinite Needs Versus Finite Resources. 1st ed. Yale University Press; 1994.
  2. Albanese AP, Bope ET, Sanders KM, Bowman M. The VA MISSION Act of 2018: a potential game changer for rural GME expansion and veteran health care. J Rural Health. 2020;36(1):133-136. doi:10.1111/jrh.12360
  3. Office of Management and Budget (US). Budget of the United States Government, Fiscal Year 2025. Washington, DC: US Government Publishing Office; 2024. Available from: US Department of Veterans Affairs FY 2025 Budget Submission: Budget in Brief.
  4. US Department of Veterans Affairs. Veteran care claims. Accessed April 3, 2025. https://www.va.gov/COMMUNITYCARE/revenue-ops/Veteran-Care-Claims.asp
  5. US Centers for Medicare and Medicaid Services. Accessed April 3, 2025. Procedure price lookup https://www.medicare.gov/procedure-price-lookup
  6. US Department of Veterans Affairs. WellHive -Enterprise. Accessed April 3, 2025. https://department.va.gov/privacy/wp-content/uploads/sites/5/2023/05/FY23WellHiveEnterprisePIA.pdf
  7. US Centers for Medicare and Medicaid Services. RVU21a physician fee schedule, January 2021 release. Accessed April 3, 2025. https://www.cms.gov/medicaremedicare-fee-service-paymentphysicianfeeschedpfs-relative-value-files/rvu21a
  8. US Centers for Medicare and Medicaid Services. RVU22a physician fee schedule, January 2022 release. Accessed April 3, 2025. https://www.cms.gov/medicaremedicare-fee-service-paymentphysicianfeeschedpfs-relative-value-files/rvu22a
  9. US Centers for Medicare and Medicaid Services. RVU23a physician fee schedule, January 2023 release. Accessed April 3, 2025. https://www.cms.gov/medicare/medicare-fee-service-payment/physicianfeesched/pfs-relative-value-files/rvu23a
  10. US Centers for Medicare and Medicaid Services. RVU23a Medicare Physician Fee Schedule rates effective January 1, 2024, through March 8, 2024. Accessed on April 3, 2025. https://www.cms.gov/medicare/payment/fee-schedules/physician/pfs-relative-value-files/rvu24a
  11. Kenamond MC, Mourad WF, Randall ME, Kaushal A. No oncology patient left behind: challenges and solutions in rural radiation oncology. Lancet Reg Health Am. 2022;13:100289. doi:10.1016/j.lana.2022.100289
  12. Mattocks KM, Kroll-Desrosiers A, Kinney R, Elwy AR, Cunningham KJ, Mengeling MA. Understanding VA’s use of and relationships with community care providers under the MISSION Act. Med Care. 2021;59(Suppl 3):S252-S258. doi:10.1097/MLR.0000000000001545
  13. Hanks GE, Dunlap K. A comparison of the cost of various treatment methods for early cancer of the prostate. Int J Radiat Oncol Biol Phys. 1986;12(10):1879-1881. doi:10.1016/0360-3016(86)90334-2
  14. American Society of Radiation Oncology. Radiation oncology case rate program (ROCR). Accessed April 3, 2025. https://www.astro.org/advocacy/key-issues-8f3e5a3b76643265ee93287d79c4fc40/rocr
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Handoff Delays in Teledermatology Lengthen Timeline of Care for Veterans With Melanoma

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Handoff Delays in Teledermatology Lengthen Timeline of Care for Veterans With Melanoma

Store-and-forward teledermatology (SFT) allows clinical images and information to be sent to a dermatologist for evaluation. In fiscal year (FY) 2018, 117,780 SFT consultations were completed in the Veterans Health Administration. Continued growth is expected since SFT has proven to be an effective method for improving access to face-to-face (FTF) dermatology care.1 In the same period, the US Department of Veterans Affairs (VA) Puget Sound Health Care System (VAPSHCS) completed 12,563 consultations in a mean 1.1 days from entry into episode of care (EEC), according to data reported by VA Teledermatology Program Administrator Chris Foster.

Obtaining a prompt consultation is reported to be an overwhelming advantage of using SFT.2-5 Rapid turnaround may appear to make SFT specialist care more accessible to veterans, yet this is an oversimplification. The process of delivering care (rather than consultation) through SFT is more complex than reading the images and reporting the findings. When a skin condition is identified by a primary care clinician and that person decides to request an SFT consultation, a complex set of tasks and handoffs is set into motion. A swim-lane diagram illustrates the numerous steps and handoffs that go into delivering care to a patient with a malignant melanoma on the SFT platform compared to FTF care, which requires fewer handoffs (Figure).

0525FED-AVAHO-MEL_F1

This process improvement project examined whether handoffs necessitated by SFT care lengthened the timeline of care for biopsy-proven primary cutaneous malignant melanoma. The stakes of delay in care are high. A 2018 study using the National Cancer Database found that a delay of > 30 days from biopsy to definitive excision (the date definitive surgical procedure for the condition is performed) resulted in a measurable increase in melanoma-related mortality. 6 This study sought to identify areas where the SFT timeline of care could be shortened.

Methods

This retrospective cohort study was approved by the VAPSHCS Institutional Review Board. The study drew from secondary data obtained from VistA, the VA Corporate Data Warehouse, the Veterans Integrated Service Network (VISN) 20 database, the American Academy of Dermatology Teledermatology Program database, and the VA Computerized Patient Record System.

Patients registered for ≥ 1 year at VAPSHCS with a diagnosis of primary cutaneous malignant melanoma by the Pathology service between January 1, 2006, and December 31, 2013, were included. Patients with metastatic or recurrent melanoma were excluded.

Cases were randomly selected from a melanoma database previously validated and used for another quality improvement project.7 There were initially 115 patient cases extracted from this database for both the FTF and SFT groups. Eighty-seven SFT and 107 FTF cases met inclusion criteria. To further analyze these groups, we split the FTF group into 2 subgroups: FTF dermatology (patients whose melanomas were entered into care in a dermatology clinic) and FTF primary care (patients whose melanomas were entered into care in primary care or a nondermatology setting).

The timeline of care was divided into 2 major time intervals: (1) entry into episode of care (EEC; the date a lesion was first documented in the electronic health record) to biopsy; and (2) biopsy to definitive excision. The SFT process was divided into the following intervals: EEC to imaging request (the date a clinician requested imaging); imaging request to imaging completion (the date an imager photographed a patient’s lesion); imaging completion to SFT consultation request (the date the SFT consultation was requested); SFT consultation request to consultation completion (the date an SFT reader completed the consultation request for a patient); and SFT consultation completion to biopsy. Mean and median interval lengths were compared between groups and additional analyses identified steps that may have contributed to delays in care.

To address potential bias based on access to care for rural veterans, SFT and FTF primary care cases were categorized into groups based on their location: (1) EEC and biopsy conducted at the same facility; (2) EEC and biopsy conducted at different facilities within the same health care system (main health care facility and its community-based outpatient clinics); and (3) EEC and biopsy conducted at different health care systems.

Statistics

Means, medians, and SDs were calculated in Excel. The Mann-Whitney U test was used to compare SFT medians to the FTF data and X2 test was used to compare proportions for secondary analyses.

Results

The median (mean) interval from EEC to definitive excision was 73 days (85) for SFT and 58 days (73) for FTF (P = .004) (Table). To understand this difference, the distribution of intervals from EEC to biopsy and biopsy to definitive excision were calculated. Only 38% of SFT cases were biopsied within 20 days compared to 65% of FTF cases (P < .001). The difference in time from biopsy to definitive excision distributions were not statistically significant, suggesting that the difference is actually a reflection of the differences seen in the period between EEC and biopsy.

0525FED-AVAHO-MEL_T1

EEC and biopsy occurred at the same facility in 85% and 82% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different facilities within the same health care system in 15% and 16% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different health care systems in 0% and 2% of FTF primary care and SFT cases, respectively. Geographic bias did not impact results for either group of veterans.

The interval between EEC and biopsy was shorter for FTF dermatology cases than for FTF primary care cases. For FTF dermatology cases, 96% were biopsied within 20 days compared with 34% of FTF primary care cases (P < .001).

To further analyze the difference in the EEC to biopsy interval duration between SFT and FTF primary care the timeline was divided into smaller steps: EEC to imaging completion, imaging completion to SFT consult completion, and SFT consult completion to biopsy. From EEC to SFT consult completion, SFT cases took a median of 6.0 days and a mean of 12.3 days, reflecting the administrative handoffs that must occur in SFT. A total of 82% of FTF primary care cases were entered into care and consultation was requested on the same day, while this was true for only 1% of SFT cases.

Since mortality data were not collected, the frequency of in situ melanomas and invasive melanomas (pathologic stage pT1a or greater) was used as a proxy for comparing outcomes. No significant difference was found in the frequency of in situ vs invasive melanomas in the SFT and FTF dermatology groups; however, there was a much higher frequency of invasive melanomas in the FTF primary care group (P = .007).

Discussion

This study compared the time to treatment for SFT vs FTF and identified important differences. The episode of care for melanomas diagnosed by SFT was statistically significantly longer (15 days) than those diagnosed by FTF. The interval between biopsy and definitive excision was a median of 34 and 38 days, and a mean of 48 and 44 days for SFT and FTF, respectively, which were not statistically significant. The difference in the total duration of the interval between EEC and definitive excision was accounted for by the duration of the interval from EEC to biopsy. When excluding dermatology clinic cases from the FTF group, there was no difference in the interval between EEC and biopsy for SFT and FTF primary care. The handoffs in SFT accounted for a median of 6 days and mean of 12 days, a significant portion of the timeline, and is a target for process improvement. The delay necessitated by handoffs did not significantly affect the distribution of in situ and invasive melanomas in the SFT and FTF dermatology groups. This suggests that SFT may have better outcomes than FTF primary care.

There has been extensive research on the timeline from the patient initially noticing a lesion to the EEC.8-11 There is also a body of research on the timeline from biopsy to definitive excision. 6,12-16 However, there has been little research on the timeline between EEC and biopsy, which comprises a large portion of the overall timeline of both SFT care and FTF care. This study analyzed the delays that can occur in this interval. When patients first enter FTF dermatology care, this timeline is quite short because lesions are often biopsied on the same day. When patients enter into care with their primary or nondermatology clinician, there can be significant delays.

Since the stakes are high when it comes to treating melanoma, it is important to minimize the overall timeline. A 6-day median and 12-day mean were established as targets for teledermatology handoffs. Ideally, a lesion should be entered into an episode of care, imaged, and sent for consultation on the same day. To help further understand delays in administrative handoffs, we stratified the SFT cases by VISN 20 sites and spoke with an administrator at a top performing site. Between 2006 and 2013, this site had a dedicated full-time imager as well as a backup imager that ensured images were taken quickly, usually on the same day the lesion was entered into care. Unfortunately, this is not the standard at all VISN 20 sites and certainly contributes to the overall delay in care in SFT

Minimizing the timeline of care is possible, as shown by the Danish health system, which developed a fast-track referral system after recognizing the need to minimize delays between the presentation, diagnosis, and treatment of cutaneous melanomas. In Denmark, a patient who presents to a general practitioner with a suspicious lesion is referred to secondary care for excision biopsy within 6 days. Diagnosis is made within 2 weeks, and, if necessary, definitive excision is offered within 9 days of the diagnosis. This translates into a maximum 20-day EEC to biopsy timeline and maximum 29-day EEC to definitive excision timeline. Although an intervention such as this may be difficult to implement in the United States due to its size and decentralized health care system, it would, however, be more realistic within the VA due to its centralized structure. The Danish system shows that with appropriate resource allocation and strict timeframes for treatment referrals, the timeline can be minimized.17

Despite the delay in the SFT timeline, this study found no significant difference between the distribution of in situ vs invasive melanomas in FTF dermatology and SFT groups. One possible explanation for this is that SFT increases access to dermatologist care, meaning clinicians may be more willing to consult SFT for less advanced– appearing lesions.

The finding that SFT diagnosed a larger proportion of in situ melanomas than FTF primary care is consistent with the findings of Ferrándiz et al, who reported that the mean Breslow thickness was significantly lower among patients in an SFT group compared to patients in an FTF group consisting of general practitioners. 18 However, the study population was not randomized and the results may have been impacted by ascertainment bias. Ferrándiz et al hypothesized that clinicians may have a lower threshold for consulting teledermatology, resulting in lower mean Breslow thicknesses.18 Karavan et al found the opposite results, with a higher mean Breslow thickness in SFT compared to a primary care FTF group.19 The data presented here suggest that SFT has room for process improvement yet is essentially equivalent to FTF dermatology in terms of outcomes.

Limitations

The majority of patients in this study were aged > 50 years, White, and male. The results may not be representative for other populations. The study was relatively small compared to studies that looked at other aspects of the melanoma care timeline. The study was not powered to ascertain mortality, the most important metric for melanoma.

Conclusions

The episode of care was significantly longer for melanomas diagnosed by SFT than those diagnosed by FTF; however, timelines were not statistically different when FTF lesions entered into care in dermatology were excluded. A median 6-day and mean 12.3-day delay in administrative handoffs occurred at the beginning of the SFT process and is a target for process improvement. Considering the high stakes of melanoma, the SFT timeline could be reduced if EEC, imaging, and SFT consultation all happened in the same day.

References
  1. Raugi GJ, Nelson W, Miethke M, et al. Teledermatology implementation in a VHA secondary treatment facility improves access to face-to-face care. Telemed J E Health. 2016;22(1):12-17. doi:10.1089/tmj.2015.0036
  2. Moreno-Ramirez D, Ferrandiz L, Nieto-Garcia A, et al. Store-and-forward teledermatology in skin cancer triage: experience and evaluation of 2009 teleconsultations. Arch Dermatol. 2007;143(4):479-484. doi:10.1001/archderm.143.4.479
  3. Landow SM, Oh DH, Weinstock MA. Teledermatology within the Veterans Health Administration, 2002–2014. Telemed J E Health. 2015;21(10):769-773. doi:10.1089/tmj.2014.0225
  4. Whited JD, Hall RP, Foy ME, et al. Teledermatology’s impact on time to intervention among referrals to a dermatology consult service. Telemed J E Health. 2002;8(3):313-321. doi:10.1089/15305620260353207
  5. Hsiao JL, Oh DH. The impact of store-and-forward teledermatology on skin cancer diagnosis and treatment. J Am Acad Dermatol. 2008;59(2):260-267. doi:10.1016/j.jaad.2008.04.011
  6. Conic RZ, Cabrera CI, Khorana AA, Gastman BR. Determination of the impact of melanoma surgical timing on survival using the National Cancer Database. J Am Acad Dermatol. 2018;78(1):40-46.e7. doi:10.1016/j.jaad.2017.08.039
  7. Dougall B, Gendreau J, Das S, et al. Melanoma registry underreporting in the Veterans Health Administration. Fed Pract. 2016;33(suppl 5):55S-59S
  8. Xavier MHSB, Drummond-Lage AP, Baeta C, Rocha L, Almeida AM, Wainstein AJA. Delay in cutaneous melanoma diagnosis: sequence analyses from suspicion to diagnosis in 211 patients. Medicine (Baltimore). 2016;95(31):e4396. doi:10.1097/md.0000000000004396
  9. Schmid-Wendtner MH, Baumert J, Stange J, Volkenandt M. Delay in the diagnosis of cutaneous melanoma: an analysis of 233 patients. Melanoma Res. 2002;12(4):389-394. doi:10.1097/00008390-200208000-00012
  10. Betti, R, Vergani R, Tolomio E, Santambrogio R, Crosti C. Factors of delay in the diagnosis of melanoma. Eur J Dermatol. 2003;13(2):183-188.
  11. Blum A, Brand CU, Ellwanger U, et al. Awareness and early detection of cutaneous melanoma: An analysis of factors related to delay in treatment. Br J Dermatol. 1999;141(5):783-787. doi:10.1046/j.1365-2133.1999.03196.x
  12. Brian T, Adams B, Jameson M. Cutaneous melanoma: an audit of management timeliness against New Zealand guidelines. N Z Med J. 2017;130(1462):54-61. https://pubmed.ncbi.nlm.nih.gov/28934768
  13. Adamson AS, Zhou L, Baggett CD, Thomas NE, Meyer AM. Association of delays in surgery for melanoma with Insurance type. JAMA Dermatol. 2017;153(11):1106-1113. doi:https://doi.org/10.1001/jamadermatol.2017.3338
  14. Niehues NB, Evanson B, Smith WA, Fiore CT, Parekh P. Melanoma patient notification and treatment timelines. Dermatol Online J. 2019;25(4)13. doi:10.5070/d3254043588
  15. Lott JP, Narayan D, Soulos PR, Aminawung J, Gross CP. Delay of surgery for melanoma among Medicare beneficiaries. JAMA Dermatol. 2015;151(7):731-741. doi:10.1001/jamadermatol.2015.119
  16. Baranowski MLH, Yeung H, Chen SC, Gillespie TW, Goodman M. Factors associated with time to surgery in melanoma: an analysis of the National Cancer Database. J Am Acad Dermatol. 2019;81(4):908-916. doi:10.1016/j.jaad.2019.05.079
  17. Jarjis RD, Hansen LB, Matzen SH. A fast-track referral system for skin lesions suspicious of melanoma: population-based cross-sectional study from a plastic surgery center. Plast Surg Int. 2016;2016:2908917. doi:10.1155/2016/2908917
  18. Ferrándiz L, Ruiz-de-Casas A, Martin-Gutierrez FJ, et al. Effect of teledermatology on the prognosis of patients with cutaneous melanoma. Arch Dermatol. 2012;148(9):1025-1028. doi:10.1001/archdermatol.2012.778
  19. Karavan M, Compton N, Knezevich S, et al. Teledermatology in the diagnosis of melanoma. J Telemed Telecare. 2014;20(1):18-23. doi:10.1177/1357633x13517354
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Samuel Byrne, BSa,b; Clayton Lau, BSa; Maya Gopalan, BSa; Sandra Mata-Diaz, BSa; Gregory J. Raugi, MD, PhDc,d

Author affiliations;
aUniversity of Washington School of Public Health, Seattle
bUniversity of Arizona College of Medicine, Phoenix
cVeterans Affairs Puget Sound Health Care System, Seattle, Washington
dUniversity of Washington Department of Medicine, Seattle

Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Samuel Byrne (sambyrne1289@gmail.com)

Fed Pract. 2025;42(suppl 2). Published online May 8. doi:10.12788/fp.0587

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Samuel Byrne, BSa,b; Clayton Lau, BSa; Maya Gopalan, BSa; Sandra Mata-Diaz, BSa; Gregory J. Raugi, MD, PhDc,d

Author affiliations;
aUniversity of Washington School of Public Health, Seattle
bUniversity of Arizona College of Medicine, Phoenix
cVeterans Affairs Puget Sound Health Care System, Seattle, Washington
dUniversity of Washington Department of Medicine, Seattle

Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Samuel Byrne (sambyrne1289@gmail.com)

Fed Pract. 2025;42(suppl 2). Published online May 8. doi:10.12788/fp.0587

Author and Disclosure Information

Samuel Byrne, BSa,b; Clayton Lau, BSa; Maya Gopalan, BSa; Sandra Mata-Diaz, BSa; Gregory J. Raugi, MD, PhDc,d

Author affiliations;
aUniversity of Washington School of Public Health, Seattle
bUniversity of Arizona College of Medicine, Phoenix
cVeterans Affairs Puget Sound Health Care System, Seattle, Washington
dUniversity of Washington Department of Medicine, Seattle

Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.

Correspondence: Samuel Byrne (sambyrne1289@gmail.com)

Fed Pract. 2025;42(suppl 2). Published online May 8. doi:10.12788/fp.0587

Article PDF
Article PDF

Store-and-forward teledermatology (SFT) allows clinical images and information to be sent to a dermatologist for evaluation. In fiscal year (FY) 2018, 117,780 SFT consultations were completed in the Veterans Health Administration. Continued growth is expected since SFT has proven to be an effective method for improving access to face-to-face (FTF) dermatology care.1 In the same period, the US Department of Veterans Affairs (VA) Puget Sound Health Care System (VAPSHCS) completed 12,563 consultations in a mean 1.1 days from entry into episode of care (EEC), according to data reported by VA Teledermatology Program Administrator Chris Foster.

Obtaining a prompt consultation is reported to be an overwhelming advantage of using SFT.2-5 Rapid turnaround may appear to make SFT specialist care more accessible to veterans, yet this is an oversimplification. The process of delivering care (rather than consultation) through SFT is more complex than reading the images and reporting the findings. When a skin condition is identified by a primary care clinician and that person decides to request an SFT consultation, a complex set of tasks and handoffs is set into motion. A swim-lane diagram illustrates the numerous steps and handoffs that go into delivering care to a patient with a malignant melanoma on the SFT platform compared to FTF care, which requires fewer handoffs (Figure).

0525FED-AVAHO-MEL_F1

This process improvement project examined whether handoffs necessitated by SFT care lengthened the timeline of care for biopsy-proven primary cutaneous malignant melanoma. The stakes of delay in care are high. A 2018 study using the National Cancer Database found that a delay of > 30 days from biopsy to definitive excision (the date definitive surgical procedure for the condition is performed) resulted in a measurable increase in melanoma-related mortality. 6 This study sought to identify areas where the SFT timeline of care could be shortened.

Methods

This retrospective cohort study was approved by the VAPSHCS Institutional Review Board. The study drew from secondary data obtained from VistA, the VA Corporate Data Warehouse, the Veterans Integrated Service Network (VISN) 20 database, the American Academy of Dermatology Teledermatology Program database, and the VA Computerized Patient Record System.

Patients registered for ≥ 1 year at VAPSHCS with a diagnosis of primary cutaneous malignant melanoma by the Pathology service between January 1, 2006, and December 31, 2013, were included. Patients with metastatic or recurrent melanoma were excluded.

Cases were randomly selected from a melanoma database previously validated and used for another quality improvement project.7 There were initially 115 patient cases extracted from this database for both the FTF and SFT groups. Eighty-seven SFT and 107 FTF cases met inclusion criteria. To further analyze these groups, we split the FTF group into 2 subgroups: FTF dermatology (patients whose melanomas were entered into care in a dermatology clinic) and FTF primary care (patients whose melanomas were entered into care in primary care or a nondermatology setting).

The timeline of care was divided into 2 major time intervals: (1) entry into episode of care (EEC; the date a lesion was first documented in the electronic health record) to biopsy; and (2) biopsy to definitive excision. The SFT process was divided into the following intervals: EEC to imaging request (the date a clinician requested imaging); imaging request to imaging completion (the date an imager photographed a patient’s lesion); imaging completion to SFT consultation request (the date the SFT consultation was requested); SFT consultation request to consultation completion (the date an SFT reader completed the consultation request for a patient); and SFT consultation completion to biopsy. Mean and median interval lengths were compared between groups and additional analyses identified steps that may have contributed to delays in care.

To address potential bias based on access to care for rural veterans, SFT and FTF primary care cases were categorized into groups based on their location: (1) EEC and biopsy conducted at the same facility; (2) EEC and biopsy conducted at different facilities within the same health care system (main health care facility and its community-based outpatient clinics); and (3) EEC and biopsy conducted at different health care systems.

Statistics

Means, medians, and SDs were calculated in Excel. The Mann-Whitney U test was used to compare SFT medians to the FTF data and X2 test was used to compare proportions for secondary analyses.

Results

The median (mean) interval from EEC to definitive excision was 73 days (85) for SFT and 58 days (73) for FTF (P = .004) (Table). To understand this difference, the distribution of intervals from EEC to biopsy and biopsy to definitive excision were calculated. Only 38% of SFT cases were biopsied within 20 days compared to 65% of FTF cases (P < .001). The difference in time from biopsy to definitive excision distributions were not statistically significant, suggesting that the difference is actually a reflection of the differences seen in the period between EEC and biopsy.

0525FED-AVAHO-MEL_T1

EEC and biopsy occurred at the same facility in 85% and 82% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different facilities within the same health care system in 15% and 16% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different health care systems in 0% and 2% of FTF primary care and SFT cases, respectively. Geographic bias did not impact results for either group of veterans.

The interval between EEC and biopsy was shorter for FTF dermatology cases than for FTF primary care cases. For FTF dermatology cases, 96% were biopsied within 20 days compared with 34% of FTF primary care cases (P < .001).

To further analyze the difference in the EEC to biopsy interval duration between SFT and FTF primary care the timeline was divided into smaller steps: EEC to imaging completion, imaging completion to SFT consult completion, and SFT consult completion to biopsy. From EEC to SFT consult completion, SFT cases took a median of 6.0 days and a mean of 12.3 days, reflecting the administrative handoffs that must occur in SFT. A total of 82% of FTF primary care cases were entered into care and consultation was requested on the same day, while this was true for only 1% of SFT cases.

Since mortality data were not collected, the frequency of in situ melanomas and invasive melanomas (pathologic stage pT1a or greater) was used as a proxy for comparing outcomes. No significant difference was found in the frequency of in situ vs invasive melanomas in the SFT and FTF dermatology groups; however, there was a much higher frequency of invasive melanomas in the FTF primary care group (P = .007).

Discussion

This study compared the time to treatment for SFT vs FTF and identified important differences. The episode of care for melanomas diagnosed by SFT was statistically significantly longer (15 days) than those diagnosed by FTF. The interval between biopsy and definitive excision was a median of 34 and 38 days, and a mean of 48 and 44 days for SFT and FTF, respectively, which were not statistically significant. The difference in the total duration of the interval between EEC and definitive excision was accounted for by the duration of the interval from EEC to biopsy. When excluding dermatology clinic cases from the FTF group, there was no difference in the interval between EEC and biopsy for SFT and FTF primary care. The handoffs in SFT accounted for a median of 6 days and mean of 12 days, a significant portion of the timeline, and is a target for process improvement. The delay necessitated by handoffs did not significantly affect the distribution of in situ and invasive melanomas in the SFT and FTF dermatology groups. This suggests that SFT may have better outcomes than FTF primary care.

There has been extensive research on the timeline from the patient initially noticing a lesion to the EEC.8-11 There is also a body of research on the timeline from biopsy to definitive excision. 6,12-16 However, there has been little research on the timeline between EEC and biopsy, which comprises a large portion of the overall timeline of both SFT care and FTF care. This study analyzed the delays that can occur in this interval. When patients first enter FTF dermatology care, this timeline is quite short because lesions are often biopsied on the same day. When patients enter into care with their primary or nondermatology clinician, there can be significant delays.

Since the stakes are high when it comes to treating melanoma, it is important to minimize the overall timeline. A 6-day median and 12-day mean were established as targets for teledermatology handoffs. Ideally, a lesion should be entered into an episode of care, imaged, and sent for consultation on the same day. To help further understand delays in administrative handoffs, we stratified the SFT cases by VISN 20 sites and spoke with an administrator at a top performing site. Between 2006 and 2013, this site had a dedicated full-time imager as well as a backup imager that ensured images were taken quickly, usually on the same day the lesion was entered into care. Unfortunately, this is not the standard at all VISN 20 sites and certainly contributes to the overall delay in care in SFT

Minimizing the timeline of care is possible, as shown by the Danish health system, which developed a fast-track referral system after recognizing the need to minimize delays between the presentation, diagnosis, and treatment of cutaneous melanomas. In Denmark, a patient who presents to a general practitioner with a suspicious lesion is referred to secondary care for excision biopsy within 6 days. Diagnosis is made within 2 weeks, and, if necessary, definitive excision is offered within 9 days of the diagnosis. This translates into a maximum 20-day EEC to biopsy timeline and maximum 29-day EEC to definitive excision timeline. Although an intervention such as this may be difficult to implement in the United States due to its size and decentralized health care system, it would, however, be more realistic within the VA due to its centralized structure. The Danish system shows that with appropriate resource allocation and strict timeframes for treatment referrals, the timeline can be minimized.17

Despite the delay in the SFT timeline, this study found no significant difference between the distribution of in situ vs invasive melanomas in FTF dermatology and SFT groups. One possible explanation for this is that SFT increases access to dermatologist care, meaning clinicians may be more willing to consult SFT for less advanced– appearing lesions.

The finding that SFT diagnosed a larger proportion of in situ melanomas than FTF primary care is consistent with the findings of Ferrándiz et al, who reported that the mean Breslow thickness was significantly lower among patients in an SFT group compared to patients in an FTF group consisting of general practitioners. 18 However, the study population was not randomized and the results may have been impacted by ascertainment bias. Ferrándiz et al hypothesized that clinicians may have a lower threshold for consulting teledermatology, resulting in lower mean Breslow thicknesses.18 Karavan et al found the opposite results, with a higher mean Breslow thickness in SFT compared to a primary care FTF group.19 The data presented here suggest that SFT has room for process improvement yet is essentially equivalent to FTF dermatology in terms of outcomes.

Limitations

The majority of patients in this study were aged > 50 years, White, and male. The results may not be representative for other populations. The study was relatively small compared to studies that looked at other aspects of the melanoma care timeline. The study was not powered to ascertain mortality, the most important metric for melanoma.

Conclusions

The episode of care was significantly longer for melanomas diagnosed by SFT than those diagnosed by FTF; however, timelines were not statistically different when FTF lesions entered into care in dermatology were excluded. A median 6-day and mean 12.3-day delay in administrative handoffs occurred at the beginning of the SFT process and is a target for process improvement. Considering the high stakes of melanoma, the SFT timeline could be reduced if EEC, imaging, and SFT consultation all happened in the same day.

Store-and-forward teledermatology (SFT) allows clinical images and information to be sent to a dermatologist for evaluation. In fiscal year (FY) 2018, 117,780 SFT consultations were completed in the Veterans Health Administration. Continued growth is expected since SFT has proven to be an effective method for improving access to face-to-face (FTF) dermatology care.1 In the same period, the US Department of Veterans Affairs (VA) Puget Sound Health Care System (VAPSHCS) completed 12,563 consultations in a mean 1.1 days from entry into episode of care (EEC), according to data reported by VA Teledermatology Program Administrator Chris Foster.

Obtaining a prompt consultation is reported to be an overwhelming advantage of using SFT.2-5 Rapid turnaround may appear to make SFT specialist care more accessible to veterans, yet this is an oversimplification. The process of delivering care (rather than consultation) through SFT is more complex than reading the images and reporting the findings. When a skin condition is identified by a primary care clinician and that person decides to request an SFT consultation, a complex set of tasks and handoffs is set into motion. A swim-lane diagram illustrates the numerous steps and handoffs that go into delivering care to a patient with a malignant melanoma on the SFT platform compared to FTF care, which requires fewer handoffs (Figure).

0525FED-AVAHO-MEL_F1

This process improvement project examined whether handoffs necessitated by SFT care lengthened the timeline of care for biopsy-proven primary cutaneous malignant melanoma. The stakes of delay in care are high. A 2018 study using the National Cancer Database found that a delay of > 30 days from biopsy to definitive excision (the date definitive surgical procedure for the condition is performed) resulted in a measurable increase in melanoma-related mortality. 6 This study sought to identify areas where the SFT timeline of care could be shortened.

Methods

This retrospective cohort study was approved by the VAPSHCS Institutional Review Board. The study drew from secondary data obtained from VistA, the VA Corporate Data Warehouse, the Veterans Integrated Service Network (VISN) 20 database, the American Academy of Dermatology Teledermatology Program database, and the VA Computerized Patient Record System.

Patients registered for ≥ 1 year at VAPSHCS with a diagnosis of primary cutaneous malignant melanoma by the Pathology service between January 1, 2006, and December 31, 2013, were included. Patients with metastatic or recurrent melanoma were excluded.

Cases were randomly selected from a melanoma database previously validated and used for another quality improvement project.7 There were initially 115 patient cases extracted from this database for both the FTF and SFT groups. Eighty-seven SFT and 107 FTF cases met inclusion criteria. To further analyze these groups, we split the FTF group into 2 subgroups: FTF dermatology (patients whose melanomas were entered into care in a dermatology clinic) and FTF primary care (patients whose melanomas were entered into care in primary care or a nondermatology setting).

The timeline of care was divided into 2 major time intervals: (1) entry into episode of care (EEC; the date a lesion was first documented in the electronic health record) to biopsy; and (2) biopsy to definitive excision. The SFT process was divided into the following intervals: EEC to imaging request (the date a clinician requested imaging); imaging request to imaging completion (the date an imager photographed a patient’s lesion); imaging completion to SFT consultation request (the date the SFT consultation was requested); SFT consultation request to consultation completion (the date an SFT reader completed the consultation request for a patient); and SFT consultation completion to biopsy. Mean and median interval lengths were compared between groups and additional analyses identified steps that may have contributed to delays in care.

To address potential bias based on access to care for rural veterans, SFT and FTF primary care cases were categorized into groups based on their location: (1) EEC and biopsy conducted at the same facility; (2) EEC and biopsy conducted at different facilities within the same health care system (main health care facility and its community-based outpatient clinics); and (3) EEC and biopsy conducted at different health care systems.

Statistics

Means, medians, and SDs were calculated in Excel. The Mann-Whitney U test was used to compare SFT medians to the FTF data and X2 test was used to compare proportions for secondary analyses.

Results

The median (mean) interval from EEC to definitive excision was 73 days (85) for SFT and 58 days (73) for FTF (P = .004) (Table). To understand this difference, the distribution of intervals from EEC to biopsy and biopsy to definitive excision were calculated. Only 38% of SFT cases were biopsied within 20 days compared to 65% of FTF cases (P < .001). The difference in time from biopsy to definitive excision distributions were not statistically significant, suggesting that the difference is actually a reflection of the differences seen in the period between EEC and biopsy.

0525FED-AVAHO-MEL_T1

EEC and biopsy occurred at the same facility in 85% and 82% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different facilities within the same health care system in 15% and 16% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different health care systems in 0% and 2% of FTF primary care and SFT cases, respectively. Geographic bias did not impact results for either group of veterans.

The interval between EEC and biopsy was shorter for FTF dermatology cases than for FTF primary care cases. For FTF dermatology cases, 96% were biopsied within 20 days compared with 34% of FTF primary care cases (P < .001).

To further analyze the difference in the EEC to biopsy interval duration between SFT and FTF primary care the timeline was divided into smaller steps: EEC to imaging completion, imaging completion to SFT consult completion, and SFT consult completion to biopsy. From EEC to SFT consult completion, SFT cases took a median of 6.0 days and a mean of 12.3 days, reflecting the administrative handoffs that must occur in SFT. A total of 82% of FTF primary care cases were entered into care and consultation was requested on the same day, while this was true for only 1% of SFT cases.

Since mortality data were not collected, the frequency of in situ melanomas and invasive melanomas (pathologic stage pT1a or greater) was used as a proxy for comparing outcomes. No significant difference was found in the frequency of in situ vs invasive melanomas in the SFT and FTF dermatology groups; however, there was a much higher frequency of invasive melanomas in the FTF primary care group (P = .007).

Discussion

This study compared the time to treatment for SFT vs FTF and identified important differences. The episode of care for melanomas diagnosed by SFT was statistically significantly longer (15 days) than those diagnosed by FTF. The interval between biopsy and definitive excision was a median of 34 and 38 days, and a mean of 48 and 44 days for SFT and FTF, respectively, which were not statistically significant. The difference in the total duration of the interval between EEC and definitive excision was accounted for by the duration of the interval from EEC to biopsy. When excluding dermatology clinic cases from the FTF group, there was no difference in the interval between EEC and biopsy for SFT and FTF primary care. The handoffs in SFT accounted for a median of 6 days and mean of 12 days, a significant portion of the timeline, and is a target for process improvement. The delay necessitated by handoffs did not significantly affect the distribution of in situ and invasive melanomas in the SFT and FTF dermatology groups. This suggests that SFT may have better outcomes than FTF primary care.

There has been extensive research on the timeline from the patient initially noticing a lesion to the EEC.8-11 There is also a body of research on the timeline from biopsy to definitive excision. 6,12-16 However, there has been little research on the timeline between EEC and biopsy, which comprises a large portion of the overall timeline of both SFT care and FTF care. This study analyzed the delays that can occur in this interval. When patients first enter FTF dermatology care, this timeline is quite short because lesions are often biopsied on the same day. When patients enter into care with their primary or nondermatology clinician, there can be significant delays.

Since the stakes are high when it comes to treating melanoma, it is important to minimize the overall timeline. A 6-day median and 12-day mean were established as targets for teledermatology handoffs. Ideally, a lesion should be entered into an episode of care, imaged, and sent for consultation on the same day. To help further understand delays in administrative handoffs, we stratified the SFT cases by VISN 20 sites and spoke with an administrator at a top performing site. Between 2006 and 2013, this site had a dedicated full-time imager as well as a backup imager that ensured images were taken quickly, usually on the same day the lesion was entered into care. Unfortunately, this is not the standard at all VISN 20 sites and certainly contributes to the overall delay in care in SFT

Minimizing the timeline of care is possible, as shown by the Danish health system, which developed a fast-track referral system after recognizing the need to minimize delays between the presentation, diagnosis, and treatment of cutaneous melanomas. In Denmark, a patient who presents to a general practitioner with a suspicious lesion is referred to secondary care for excision biopsy within 6 days. Diagnosis is made within 2 weeks, and, if necessary, definitive excision is offered within 9 days of the diagnosis. This translates into a maximum 20-day EEC to biopsy timeline and maximum 29-day EEC to definitive excision timeline. Although an intervention such as this may be difficult to implement in the United States due to its size and decentralized health care system, it would, however, be more realistic within the VA due to its centralized structure. The Danish system shows that with appropriate resource allocation and strict timeframes for treatment referrals, the timeline can be minimized.17

Despite the delay in the SFT timeline, this study found no significant difference between the distribution of in situ vs invasive melanomas in FTF dermatology and SFT groups. One possible explanation for this is that SFT increases access to dermatologist care, meaning clinicians may be more willing to consult SFT for less advanced– appearing lesions.

The finding that SFT diagnosed a larger proportion of in situ melanomas than FTF primary care is consistent with the findings of Ferrándiz et al, who reported that the mean Breslow thickness was significantly lower among patients in an SFT group compared to patients in an FTF group consisting of general practitioners. 18 However, the study population was not randomized and the results may have been impacted by ascertainment bias. Ferrándiz et al hypothesized that clinicians may have a lower threshold for consulting teledermatology, resulting in lower mean Breslow thicknesses.18 Karavan et al found the opposite results, with a higher mean Breslow thickness in SFT compared to a primary care FTF group.19 The data presented here suggest that SFT has room for process improvement yet is essentially equivalent to FTF dermatology in terms of outcomes.

Limitations

The majority of patients in this study were aged > 50 years, White, and male. The results may not be representative for other populations. The study was relatively small compared to studies that looked at other aspects of the melanoma care timeline. The study was not powered to ascertain mortality, the most important metric for melanoma.

Conclusions

The episode of care was significantly longer for melanomas diagnosed by SFT than those diagnosed by FTF; however, timelines were not statistically different when FTF lesions entered into care in dermatology were excluded. A median 6-day and mean 12.3-day delay in administrative handoffs occurred at the beginning of the SFT process and is a target for process improvement. Considering the high stakes of melanoma, the SFT timeline could be reduced if EEC, imaging, and SFT consultation all happened in the same day.

References
  1. Raugi GJ, Nelson W, Miethke M, et al. Teledermatology implementation in a VHA secondary treatment facility improves access to face-to-face care. Telemed J E Health. 2016;22(1):12-17. doi:10.1089/tmj.2015.0036
  2. Moreno-Ramirez D, Ferrandiz L, Nieto-Garcia A, et al. Store-and-forward teledermatology in skin cancer triage: experience and evaluation of 2009 teleconsultations. Arch Dermatol. 2007;143(4):479-484. doi:10.1001/archderm.143.4.479
  3. Landow SM, Oh DH, Weinstock MA. Teledermatology within the Veterans Health Administration, 2002–2014. Telemed J E Health. 2015;21(10):769-773. doi:10.1089/tmj.2014.0225
  4. Whited JD, Hall RP, Foy ME, et al. Teledermatology’s impact on time to intervention among referrals to a dermatology consult service. Telemed J E Health. 2002;8(3):313-321. doi:10.1089/15305620260353207
  5. Hsiao JL, Oh DH. The impact of store-and-forward teledermatology on skin cancer diagnosis and treatment. J Am Acad Dermatol. 2008;59(2):260-267. doi:10.1016/j.jaad.2008.04.011
  6. Conic RZ, Cabrera CI, Khorana AA, Gastman BR. Determination of the impact of melanoma surgical timing on survival using the National Cancer Database. J Am Acad Dermatol. 2018;78(1):40-46.e7. doi:10.1016/j.jaad.2017.08.039
  7. Dougall B, Gendreau J, Das S, et al. Melanoma registry underreporting in the Veterans Health Administration. Fed Pract. 2016;33(suppl 5):55S-59S
  8. Xavier MHSB, Drummond-Lage AP, Baeta C, Rocha L, Almeida AM, Wainstein AJA. Delay in cutaneous melanoma diagnosis: sequence analyses from suspicion to diagnosis in 211 patients. Medicine (Baltimore). 2016;95(31):e4396. doi:10.1097/md.0000000000004396
  9. Schmid-Wendtner MH, Baumert J, Stange J, Volkenandt M. Delay in the diagnosis of cutaneous melanoma: an analysis of 233 patients. Melanoma Res. 2002;12(4):389-394. doi:10.1097/00008390-200208000-00012
  10. Betti, R, Vergani R, Tolomio E, Santambrogio R, Crosti C. Factors of delay in the diagnosis of melanoma. Eur J Dermatol. 2003;13(2):183-188.
  11. Blum A, Brand CU, Ellwanger U, et al. Awareness and early detection of cutaneous melanoma: An analysis of factors related to delay in treatment. Br J Dermatol. 1999;141(5):783-787. doi:10.1046/j.1365-2133.1999.03196.x
  12. Brian T, Adams B, Jameson M. Cutaneous melanoma: an audit of management timeliness against New Zealand guidelines. N Z Med J. 2017;130(1462):54-61. https://pubmed.ncbi.nlm.nih.gov/28934768
  13. Adamson AS, Zhou L, Baggett CD, Thomas NE, Meyer AM. Association of delays in surgery for melanoma with Insurance type. JAMA Dermatol. 2017;153(11):1106-1113. doi:https://doi.org/10.1001/jamadermatol.2017.3338
  14. Niehues NB, Evanson B, Smith WA, Fiore CT, Parekh P. Melanoma patient notification and treatment timelines. Dermatol Online J. 2019;25(4)13. doi:10.5070/d3254043588
  15. Lott JP, Narayan D, Soulos PR, Aminawung J, Gross CP. Delay of surgery for melanoma among Medicare beneficiaries. JAMA Dermatol. 2015;151(7):731-741. doi:10.1001/jamadermatol.2015.119
  16. Baranowski MLH, Yeung H, Chen SC, Gillespie TW, Goodman M. Factors associated with time to surgery in melanoma: an analysis of the National Cancer Database. J Am Acad Dermatol. 2019;81(4):908-916. doi:10.1016/j.jaad.2019.05.079
  17. Jarjis RD, Hansen LB, Matzen SH. A fast-track referral system for skin lesions suspicious of melanoma: population-based cross-sectional study from a plastic surgery center. Plast Surg Int. 2016;2016:2908917. doi:10.1155/2016/2908917
  18. Ferrándiz L, Ruiz-de-Casas A, Martin-Gutierrez FJ, et al. Effect of teledermatology on the prognosis of patients with cutaneous melanoma. Arch Dermatol. 2012;148(9):1025-1028. doi:10.1001/archdermatol.2012.778
  19. Karavan M, Compton N, Knezevich S, et al. Teledermatology in the diagnosis of melanoma. J Telemed Telecare. 2014;20(1):18-23. doi:10.1177/1357633x13517354
References
  1. Raugi GJ, Nelson W, Miethke M, et al. Teledermatology implementation in a VHA secondary treatment facility improves access to face-to-face care. Telemed J E Health. 2016;22(1):12-17. doi:10.1089/tmj.2015.0036
  2. Moreno-Ramirez D, Ferrandiz L, Nieto-Garcia A, et al. Store-and-forward teledermatology in skin cancer triage: experience and evaluation of 2009 teleconsultations. Arch Dermatol. 2007;143(4):479-484. doi:10.1001/archderm.143.4.479
  3. Landow SM, Oh DH, Weinstock MA. Teledermatology within the Veterans Health Administration, 2002–2014. Telemed J E Health. 2015;21(10):769-773. doi:10.1089/tmj.2014.0225
  4. Whited JD, Hall RP, Foy ME, et al. Teledermatology’s impact on time to intervention among referrals to a dermatology consult service. Telemed J E Health. 2002;8(3):313-321. doi:10.1089/15305620260353207
  5. Hsiao JL, Oh DH. The impact of store-and-forward teledermatology on skin cancer diagnosis and treatment. J Am Acad Dermatol. 2008;59(2):260-267. doi:10.1016/j.jaad.2008.04.011
  6. Conic RZ, Cabrera CI, Khorana AA, Gastman BR. Determination of the impact of melanoma surgical timing on survival using the National Cancer Database. J Am Acad Dermatol. 2018;78(1):40-46.e7. doi:10.1016/j.jaad.2017.08.039
  7. Dougall B, Gendreau J, Das S, et al. Melanoma registry underreporting in the Veterans Health Administration. Fed Pract. 2016;33(suppl 5):55S-59S
  8. Xavier MHSB, Drummond-Lage AP, Baeta C, Rocha L, Almeida AM, Wainstein AJA. Delay in cutaneous melanoma diagnosis: sequence analyses from suspicion to diagnosis in 211 patients. Medicine (Baltimore). 2016;95(31):e4396. doi:10.1097/md.0000000000004396
  9. Schmid-Wendtner MH, Baumert J, Stange J, Volkenandt M. Delay in the diagnosis of cutaneous melanoma: an analysis of 233 patients. Melanoma Res. 2002;12(4):389-394. doi:10.1097/00008390-200208000-00012
  10. Betti, R, Vergani R, Tolomio E, Santambrogio R, Crosti C. Factors of delay in the diagnosis of melanoma. Eur J Dermatol. 2003;13(2):183-188.
  11. Blum A, Brand CU, Ellwanger U, et al. Awareness and early detection of cutaneous melanoma: An analysis of factors related to delay in treatment. Br J Dermatol. 1999;141(5):783-787. doi:10.1046/j.1365-2133.1999.03196.x
  12. Brian T, Adams B, Jameson M. Cutaneous melanoma: an audit of management timeliness against New Zealand guidelines. N Z Med J. 2017;130(1462):54-61. https://pubmed.ncbi.nlm.nih.gov/28934768
  13. Adamson AS, Zhou L, Baggett CD, Thomas NE, Meyer AM. Association of delays in surgery for melanoma with Insurance type. JAMA Dermatol. 2017;153(11):1106-1113. doi:https://doi.org/10.1001/jamadermatol.2017.3338
  14. Niehues NB, Evanson B, Smith WA, Fiore CT, Parekh P. Melanoma patient notification and treatment timelines. Dermatol Online J. 2019;25(4)13. doi:10.5070/d3254043588
  15. Lott JP, Narayan D, Soulos PR, Aminawung J, Gross CP. Delay of surgery for melanoma among Medicare beneficiaries. JAMA Dermatol. 2015;151(7):731-741. doi:10.1001/jamadermatol.2015.119
  16. Baranowski MLH, Yeung H, Chen SC, Gillespie TW, Goodman M. Factors associated with time to surgery in melanoma: an analysis of the National Cancer Database. J Am Acad Dermatol. 2019;81(4):908-916. doi:10.1016/j.jaad.2019.05.079
  17. Jarjis RD, Hansen LB, Matzen SH. A fast-track referral system for skin lesions suspicious of melanoma: population-based cross-sectional study from a plastic surgery center. Plast Surg Int. 2016;2016:2908917. doi:10.1155/2016/2908917
  18. Ferrándiz L, Ruiz-de-Casas A, Martin-Gutierrez FJ, et al. Effect of teledermatology on the prognosis of patients with cutaneous melanoma. Arch Dermatol. 2012;148(9):1025-1028. doi:10.1001/archdermatol.2012.778
  19. Karavan M, Compton N, Knezevich S, et al. Teledermatology in the diagnosis of melanoma. J Telemed Telecare. 2014;20(1):18-23. doi:10.1177/1357633x13517354
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Evaluating Access to Full-Body Skin Examinations in Los Angeles County, California

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Evaluating Access to Full-Body Skin Examinations in Los Angeles County, California

To the Editor:

Early skin cancer detection improves patient outcomes1; however, socioeconomic and racial disparities may impact access to dermatologic care.2 Although non-Hispanic White individuals have a high incidence of skin cancer, they experience higher melanoma-specific survival rates than non-White patients, who often receive later-stage diagnoses and experience higher mortality.2 Furthermore, racial/ ethnic minorities often face longer surgery wait times after diagnosis and have lower socioeconomic status (SES) and less favorable health insurance coverage, contributing to poorer outcomes.2,3

To examine access to full-body skin examinations (FBSEs) by board-certified dermatologists in Los Angeles (LA) County, California, we analyzed the availability of FBSEs based on racial demographics, income, and insurance type (Medicaid [Medi-Cal] vs private [Blue Cross Blue Shield (BCBS)]). Demographic data by zip code were obtained from the US Census Bureau.4 This validated metric highlights socioeconomic disparities and minimizes data gaps5,6 and was used to assess health care access among different population subgroups. Dermatologists’ contact information was obtained from the Find a Dermatologist page on the American Academy of Dermatology website and the listed phone numbers of their practice were used to contact them. Practices with board-certified dermatologists accepting new patients were included in the study; practices were not included if they had exclusive insurance plans; were pediatric, cosmetic, or research only; or were nonresponsive to calls. From August 2022 to September 2022, each practice was called twice within a 36-hour period—once by a simulated patient with Medi-Cal and once by a simulated patient with BCBS—and were asked about availability for new patient FBSE appointments and accepted insurance types. Data were analyzed using SAS software (SAS Institute Inc.).

Los Angeles County comprises 269 zip codes, of which 82 (30.5%) have dermatology practices. Of 213 total dermatologists in LA County listed on the American Academy of Dermatology website, 193 (90.6%) met preliminary criteria, and 169 (79.3%) were successfully contacted. Almost all (94.6% [160/169]) accepted new patients for FBSEs; of those, 63.1% (101/160) accepted only private insurance, 16.9% (27/160) accepted both private insurance and Medi-Cal, and 16.2% (26/160) did not accept any insurance. Racial predominance for each dermatology practice was analyzed by zip code (Table). Dermatologists included in our study were significantly more concentrated in predominantly non- Hispanic White areas of LA County vs predominantly Hispanic areas (P<.0001). Notably, the average income in predominantly non-Hispanic White zip codes ($114,757.74) was significantly higher than in predominantly Hispanic areas ($58,278.54)(P=.001)(Table).4

CT115005167-Table

In LA County, 40.1% (108/269) of zip codes have no racial majority, 28.2% (76/269) are predominantly Hispanic, 27.5% (74/269) are predominantly non-Hispanic White, 2.2% (6/269) are predominantly Black, and 1.9% (5/269) are predominantly Asian.4 There are no dermatologists in predominantly Black zip codes, 2 in predominantly Asian zip codes, 14 in predominantly Hispanic zip codes, 38 in zip codes with no racial majority, and 106 in predominantly non-Hispanic White zip codes. There are significantly more dermatologists in predominantly non-Hispanic White zip codes compared to predominantly Hispanic zip codes (P<.0001). In LA County, the average income in predominantly Asian, non-Hispanic White, and Hispanic zip codes was $93,594, $114,757.84, and $58,278.54, respectively, in 2021.4 The average income in predominantly non-Hispanic White zip codes was significantly higher than in predominantly Hispanic zip codes (P=.001). There were no income data available for predominantly Black zip codes or zip codes with no racial majority.

The results from our study revealed potential barriers to FBSEs for racial and ethnic minorities in LA County, which supports previous research on the impact of SES, race, and insurance on access to dermatologic care.2,3 Predominantly Hispanic zip codes have significantly lower income (P<.0001) and fewer dermatologists (P=.001) compared to zip codes that are predominantly non-Hispanic White, reflecting how lower SES correlates with worse health outcomes and higher melanoma mortality. Conversely, predominantly non-Hispanic White areas with higher income have better access to dermatologists, which may contribute to the improved melanoma survival rates among White patients. Additionally, most dermatologists accept only private insurance, further highlighting the disparity in FBSE access for non-White patients across LA County. While our study focused on FBSE access, our findings may point to a wider barrier to dermatologic care, especially in zip codes with fewer dermatologists. Further studies are needed to determine whether these areas also face barriers to accessing primary care.

Our study was limited by the exclusion of nonphysician providers (eg, nurse practitioners, physician assistants), a small sample size, and lack of available economic data for predominantly Black zip codes.4 Additionally, the exclusion of practices with exclusive insurance plans (eg, Kaiser Permanente) limited the generalizability of our findings, as our results did not account for the populations served by these practices. Furthermore, our analysis did not account for variations in practice size or the proportion of care provided to patients with different insurance types, which could impact overall accessibility. Additional studies are needed to explore the impact of these factors on access to general dermatologic care and not just FBSEs.

Racial/ethnic minorities and lower SES populations face major barriers to FBSE access in LA County, such as difficulty finding a dermatologist in their area or one who accepts Medi-Cal. Addressing these disparities is crucial for improving skin cancer outcomes. Further research is needed to develop strategies to eliminate these barriers to dermatologic care, such as increasing access to teledermatology, offering mobile dermatology clinics, and improving insurance coverage.

References
  1. Chiaravalloti AJ, Laduca JR. Melanoma screening by means of complete skin exams for all patients in a dermatology practice reduces the thickness of primary melanomas at diagnosis. J Clin Aesthet Dermatol. 2014;7:18-22.
  2. Qian Y, Johannet P, Sawyers A, et al. The ongoing racial disparities in melanoma: an analysis of the Surveillance, Epidemiology, and End Results database (1975-2016). J Am Acad Dermatol. 2021;84:1585-1593.
  3. Baranowski MLH, Yeung H, Chen SC, et al. Factors associated with time to surgery in melanoma: an analysis of the National Cancer Database. J Am Acad Dermatol. 2019;81:908-916.
  4. United States Census Bureau. Explore census data. Accessed March 17, 2025. https://data.census.gov/all?q=los+angeles+county
  5. Berkowitz SA, Traore CY, Singer DE, et al. Evaluating area-based socioeconomic status indicators for monitoring disparities within health care systems: results from a primary care network. Health Serv Res. 2015;50:398-417.
  6. Jacobs B, Ir P, Bigdeli M, et al. Addressing access barriers to health services: an analytical framework for selecting appropriate interventions in lowincome Asian countries. Health Policy Plan. 2012;27:288-300.
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Marine Minasyan, Marian Banh, Kyra Diehl, Elise Krippaehne, Dr. Kesler, Dr. Goulding, Michelle Booth, Marissa Tran, Kiana Hosseinian, Nejma Wais, Amal Shafi, Suha Godil, Monique Cantu, and Niyati Panchal are from the College of Osteopathic Medicine of the Pacific, Western University of Health Science, Pomona, California. Drs. Yumeen and Wisco are from the Department of Dermatology, Warren Alpert Medical School, Brown University, Providence, Rhode Island. Ganesh Tilve is from Mercer Healthcare Consulting, Irvine, California. Dr. Vance is from the Department of Exercise and Nutrition Sciences, State University of New York, Plattsburgh.

The authors have no relevant financial disclosures to report.

This study received approval from Western University of Health Sciences institutional review board (IRB X24044).

Correspondence: Marine Minasyan, BS (marine.minasyan@westernu.edu).

Cutis. 2025 May;115(5):167-168. doi:10.12788/cutis.1210

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Marine Minasyan, Marian Banh, Kyra Diehl, Elise Krippaehne, Dr. Kesler, Dr. Goulding, Michelle Booth, Marissa Tran, Kiana Hosseinian, Nejma Wais, Amal Shafi, Suha Godil, Monique Cantu, and Niyati Panchal are from the College of Osteopathic Medicine of the Pacific, Western University of Health Science, Pomona, California. Drs. Yumeen and Wisco are from the Department of Dermatology, Warren Alpert Medical School, Brown University, Providence, Rhode Island. Ganesh Tilve is from Mercer Healthcare Consulting, Irvine, California. Dr. Vance is from the Department of Exercise and Nutrition Sciences, State University of New York, Plattsburgh.

The authors have no relevant financial disclosures to report.

This study received approval from Western University of Health Sciences institutional review board (IRB X24044).

Correspondence: Marine Minasyan, BS (marine.minasyan@westernu.edu).

Cutis. 2025 May;115(5):167-168. doi:10.12788/cutis.1210

Author and Disclosure Information

Marine Minasyan, Marian Banh, Kyra Diehl, Elise Krippaehne, Dr. Kesler, Dr. Goulding, Michelle Booth, Marissa Tran, Kiana Hosseinian, Nejma Wais, Amal Shafi, Suha Godil, Monique Cantu, and Niyati Panchal are from the College of Osteopathic Medicine of the Pacific, Western University of Health Science, Pomona, California. Drs. Yumeen and Wisco are from the Department of Dermatology, Warren Alpert Medical School, Brown University, Providence, Rhode Island. Ganesh Tilve is from Mercer Healthcare Consulting, Irvine, California. Dr. Vance is from the Department of Exercise and Nutrition Sciences, State University of New York, Plattsburgh.

The authors have no relevant financial disclosures to report.

This study received approval from Western University of Health Sciences institutional review board (IRB X24044).

Correspondence: Marine Minasyan, BS (marine.minasyan@westernu.edu).

Cutis. 2025 May;115(5):167-168. doi:10.12788/cutis.1210

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To the Editor:

Early skin cancer detection improves patient outcomes1; however, socioeconomic and racial disparities may impact access to dermatologic care.2 Although non-Hispanic White individuals have a high incidence of skin cancer, they experience higher melanoma-specific survival rates than non-White patients, who often receive later-stage diagnoses and experience higher mortality.2 Furthermore, racial/ ethnic minorities often face longer surgery wait times after diagnosis and have lower socioeconomic status (SES) and less favorable health insurance coverage, contributing to poorer outcomes.2,3

To examine access to full-body skin examinations (FBSEs) by board-certified dermatologists in Los Angeles (LA) County, California, we analyzed the availability of FBSEs based on racial demographics, income, and insurance type (Medicaid [Medi-Cal] vs private [Blue Cross Blue Shield (BCBS)]). Demographic data by zip code were obtained from the US Census Bureau.4 This validated metric highlights socioeconomic disparities and minimizes data gaps5,6 and was used to assess health care access among different population subgroups. Dermatologists’ contact information was obtained from the Find a Dermatologist page on the American Academy of Dermatology website and the listed phone numbers of their practice were used to contact them. Practices with board-certified dermatologists accepting new patients were included in the study; practices were not included if they had exclusive insurance plans; were pediatric, cosmetic, or research only; or were nonresponsive to calls. From August 2022 to September 2022, each practice was called twice within a 36-hour period—once by a simulated patient with Medi-Cal and once by a simulated patient with BCBS—and were asked about availability for new patient FBSE appointments and accepted insurance types. Data were analyzed using SAS software (SAS Institute Inc.).

Los Angeles County comprises 269 zip codes, of which 82 (30.5%) have dermatology practices. Of 213 total dermatologists in LA County listed on the American Academy of Dermatology website, 193 (90.6%) met preliminary criteria, and 169 (79.3%) were successfully contacted. Almost all (94.6% [160/169]) accepted new patients for FBSEs; of those, 63.1% (101/160) accepted only private insurance, 16.9% (27/160) accepted both private insurance and Medi-Cal, and 16.2% (26/160) did not accept any insurance. Racial predominance for each dermatology practice was analyzed by zip code (Table). Dermatologists included in our study were significantly more concentrated in predominantly non- Hispanic White areas of LA County vs predominantly Hispanic areas (P<.0001). Notably, the average income in predominantly non-Hispanic White zip codes ($114,757.74) was significantly higher than in predominantly Hispanic areas ($58,278.54)(P=.001)(Table).4

CT115005167-Table

In LA County, 40.1% (108/269) of zip codes have no racial majority, 28.2% (76/269) are predominantly Hispanic, 27.5% (74/269) are predominantly non-Hispanic White, 2.2% (6/269) are predominantly Black, and 1.9% (5/269) are predominantly Asian.4 There are no dermatologists in predominantly Black zip codes, 2 in predominantly Asian zip codes, 14 in predominantly Hispanic zip codes, 38 in zip codes with no racial majority, and 106 in predominantly non-Hispanic White zip codes. There are significantly more dermatologists in predominantly non-Hispanic White zip codes compared to predominantly Hispanic zip codes (P<.0001). In LA County, the average income in predominantly Asian, non-Hispanic White, and Hispanic zip codes was $93,594, $114,757.84, and $58,278.54, respectively, in 2021.4 The average income in predominantly non-Hispanic White zip codes was significantly higher than in predominantly Hispanic zip codes (P=.001). There were no income data available for predominantly Black zip codes or zip codes with no racial majority.

The results from our study revealed potential barriers to FBSEs for racial and ethnic minorities in LA County, which supports previous research on the impact of SES, race, and insurance on access to dermatologic care.2,3 Predominantly Hispanic zip codes have significantly lower income (P<.0001) and fewer dermatologists (P=.001) compared to zip codes that are predominantly non-Hispanic White, reflecting how lower SES correlates with worse health outcomes and higher melanoma mortality. Conversely, predominantly non-Hispanic White areas with higher income have better access to dermatologists, which may contribute to the improved melanoma survival rates among White patients. Additionally, most dermatologists accept only private insurance, further highlighting the disparity in FBSE access for non-White patients across LA County. While our study focused on FBSE access, our findings may point to a wider barrier to dermatologic care, especially in zip codes with fewer dermatologists. Further studies are needed to determine whether these areas also face barriers to accessing primary care.

Our study was limited by the exclusion of nonphysician providers (eg, nurse practitioners, physician assistants), a small sample size, and lack of available economic data for predominantly Black zip codes.4 Additionally, the exclusion of practices with exclusive insurance plans (eg, Kaiser Permanente) limited the generalizability of our findings, as our results did not account for the populations served by these practices. Furthermore, our analysis did not account for variations in practice size or the proportion of care provided to patients with different insurance types, which could impact overall accessibility. Additional studies are needed to explore the impact of these factors on access to general dermatologic care and not just FBSEs.

Racial/ethnic minorities and lower SES populations face major barriers to FBSE access in LA County, such as difficulty finding a dermatologist in their area or one who accepts Medi-Cal. Addressing these disparities is crucial for improving skin cancer outcomes. Further research is needed to develop strategies to eliminate these barriers to dermatologic care, such as increasing access to teledermatology, offering mobile dermatology clinics, and improving insurance coverage.

To the Editor:

Early skin cancer detection improves patient outcomes1; however, socioeconomic and racial disparities may impact access to dermatologic care.2 Although non-Hispanic White individuals have a high incidence of skin cancer, they experience higher melanoma-specific survival rates than non-White patients, who often receive later-stage diagnoses and experience higher mortality.2 Furthermore, racial/ ethnic minorities often face longer surgery wait times after diagnosis and have lower socioeconomic status (SES) and less favorable health insurance coverage, contributing to poorer outcomes.2,3

To examine access to full-body skin examinations (FBSEs) by board-certified dermatologists in Los Angeles (LA) County, California, we analyzed the availability of FBSEs based on racial demographics, income, and insurance type (Medicaid [Medi-Cal] vs private [Blue Cross Blue Shield (BCBS)]). Demographic data by zip code were obtained from the US Census Bureau.4 This validated metric highlights socioeconomic disparities and minimizes data gaps5,6 and was used to assess health care access among different population subgroups. Dermatologists’ contact information was obtained from the Find a Dermatologist page on the American Academy of Dermatology website and the listed phone numbers of their practice were used to contact them. Practices with board-certified dermatologists accepting new patients were included in the study; practices were not included if they had exclusive insurance plans; were pediatric, cosmetic, or research only; or were nonresponsive to calls. From August 2022 to September 2022, each practice was called twice within a 36-hour period—once by a simulated patient with Medi-Cal and once by a simulated patient with BCBS—and were asked about availability for new patient FBSE appointments and accepted insurance types. Data were analyzed using SAS software (SAS Institute Inc.).

Los Angeles County comprises 269 zip codes, of which 82 (30.5%) have dermatology practices. Of 213 total dermatologists in LA County listed on the American Academy of Dermatology website, 193 (90.6%) met preliminary criteria, and 169 (79.3%) were successfully contacted. Almost all (94.6% [160/169]) accepted new patients for FBSEs; of those, 63.1% (101/160) accepted only private insurance, 16.9% (27/160) accepted both private insurance and Medi-Cal, and 16.2% (26/160) did not accept any insurance. Racial predominance for each dermatology practice was analyzed by zip code (Table). Dermatologists included in our study were significantly more concentrated in predominantly non- Hispanic White areas of LA County vs predominantly Hispanic areas (P<.0001). Notably, the average income in predominantly non-Hispanic White zip codes ($114,757.74) was significantly higher than in predominantly Hispanic areas ($58,278.54)(P=.001)(Table).4

CT115005167-Table

In LA County, 40.1% (108/269) of zip codes have no racial majority, 28.2% (76/269) are predominantly Hispanic, 27.5% (74/269) are predominantly non-Hispanic White, 2.2% (6/269) are predominantly Black, and 1.9% (5/269) are predominantly Asian.4 There are no dermatologists in predominantly Black zip codes, 2 in predominantly Asian zip codes, 14 in predominantly Hispanic zip codes, 38 in zip codes with no racial majority, and 106 in predominantly non-Hispanic White zip codes. There are significantly more dermatologists in predominantly non-Hispanic White zip codes compared to predominantly Hispanic zip codes (P<.0001). In LA County, the average income in predominantly Asian, non-Hispanic White, and Hispanic zip codes was $93,594, $114,757.84, and $58,278.54, respectively, in 2021.4 The average income in predominantly non-Hispanic White zip codes was significantly higher than in predominantly Hispanic zip codes (P=.001). There were no income data available for predominantly Black zip codes or zip codes with no racial majority.

The results from our study revealed potential barriers to FBSEs for racial and ethnic minorities in LA County, which supports previous research on the impact of SES, race, and insurance on access to dermatologic care.2,3 Predominantly Hispanic zip codes have significantly lower income (P<.0001) and fewer dermatologists (P=.001) compared to zip codes that are predominantly non-Hispanic White, reflecting how lower SES correlates with worse health outcomes and higher melanoma mortality. Conversely, predominantly non-Hispanic White areas with higher income have better access to dermatologists, which may contribute to the improved melanoma survival rates among White patients. Additionally, most dermatologists accept only private insurance, further highlighting the disparity in FBSE access for non-White patients across LA County. While our study focused on FBSE access, our findings may point to a wider barrier to dermatologic care, especially in zip codes with fewer dermatologists. Further studies are needed to determine whether these areas also face barriers to accessing primary care.

Our study was limited by the exclusion of nonphysician providers (eg, nurse practitioners, physician assistants), a small sample size, and lack of available economic data for predominantly Black zip codes.4 Additionally, the exclusion of practices with exclusive insurance plans (eg, Kaiser Permanente) limited the generalizability of our findings, as our results did not account for the populations served by these practices. Furthermore, our analysis did not account for variations in practice size or the proportion of care provided to patients with different insurance types, which could impact overall accessibility. Additional studies are needed to explore the impact of these factors on access to general dermatologic care and not just FBSEs.

Racial/ethnic minorities and lower SES populations face major barriers to FBSE access in LA County, such as difficulty finding a dermatologist in their area or one who accepts Medi-Cal. Addressing these disparities is crucial for improving skin cancer outcomes. Further research is needed to develop strategies to eliminate these barriers to dermatologic care, such as increasing access to teledermatology, offering mobile dermatology clinics, and improving insurance coverage.

References
  1. Chiaravalloti AJ, Laduca JR. Melanoma screening by means of complete skin exams for all patients in a dermatology practice reduces the thickness of primary melanomas at diagnosis. J Clin Aesthet Dermatol. 2014;7:18-22.
  2. Qian Y, Johannet P, Sawyers A, et al. The ongoing racial disparities in melanoma: an analysis of the Surveillance, Epidemiology, and End Results database (1975-2016). J Am Acad Dermatol. 2021;84:1585-1593.
  3. Baranowski MLH, Yeung H, Chen SC, et al. Factors associated with time to surgery in melanoma: an analysis of the National Cancer Database. J Am Acad Dermatol. 2019;81:908-916.
  4. United States Census Bureau. Explore census data. Accessed March 17, 2025. https://data.census.gov/all?q=los+angeles+county
  5. Berkowitz SA, Traore CY, Singer DE, et al. Evaluating area-based socioeconomic status indicators for monitoring disparities within health care systems: results from a primary care network. Health Serv Res. 2015;50:398-417.
  6. Jacobs B, Ir P, Bigdeli M, et al. Addressing access barriers to health services: an analytical framework for selecting appropriate interventions in lowincome Asian countries. Health Policy Plan. 2012;27:288-300.
References
  1. Chiaravalloti AJ, Laduca JR. Melanoma screening by means of complete skin exams for all patients in a dermatology practice reduces the thickness of primary melanomas at diagnosis. J Clin Aesthet Dermatol. 2014;7:18-22.
  2. Qian Y, Johannet P, Sawyers A, et al. The ongoing racial disparities in melanoma: an analysis of the Surveillance, Epidemiology, and End Results database (1975-2016). J Am Acad Dermatol. 2021;84:1585-1593.
  3. Baranowski MLH, Yeung H, Chen SC, et al. Factors associated with time to surgery in melanoma: an analysis of the National Cancer Database. J Am Acad Dermatol. 2019;81:908-916.
  4. United States Census Bureau. Explore census data. Accessed March 17, 2025. https://data.census.gov/all?q=los+angeles+county
  5. Berkowitz SA, Traore CY, Singer DE, et al. Evaluating area-based socioeconomic status indicators for monitoring disparities within health care systems: results from a primary care network. Health Serv Res. 2015;50:398-417.
  6. Jacobs B, Ir P, Bigdeli M, et al. Addressing access barriers to health services: an analytical framework for selecting appropriate interventions in lowincome Asian countries. Health Policy Plan. 2012;27:288-300.
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Evaluating Access to Full-Body Skin Examinations in Los Angeles County, California

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  • Socioeconomic and racial disparities impact access to full-body skin examinations (FBSEs) in Los Angeles County.
  • Most dermatologists included in this study were accepting new patients for a FBSE.
  • There are significantly more dermatologists in predominantly non-Hispanic White zip codes than in predominantly Hispanic zip codes in Los Angeles County.
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Clinical Accuracy of Skin Cancer Diagnosis: Investigation of Keratinocyte Carcinoma Mismatch Rates

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Clinical Accuracy of Skin Cancer Diagnosis: Investigation of Keratinocyte Carcinoma Mismatch Rates

To the Editor:

The incidence of nonmelanoma skin cancer (NMSC) is rapidly increasing worldwide. Due to its highly curable nature when treated early, accurate diagnosis is the cornerstone to good patient outcomes.1 Accurate diagnosis of skin cancer and subsequent treatment decisions rely heavily on the congruence between clinical observations and histopathologic assessments. Clinical misdiagnosis of a malignant lesion can lead to delayed and suboptimal treatment, which may contribute to serious complications such as metastasis or even mortality. In this study, data from clinically diagnosed basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs) were compared to their identified histopathologic subtype classifications. The accuracy of the clinical diagnosis of these NMSCs was assessed by determining the rate of misdiagnosis and the respective positive predictive value (PPV).

A retrospective review of medical records from a private dermatology practice in Lubbock, Texas, was conducted to identify patients diagnosed with NMSC from January 1, 2017, through December 31, 2021. A total of 11,229 NMSCs were diagnosed and treated in 5877 patients. Of the NMSCs diagnosed, 11,145 were identified as keratinocyte carcinomas and were classified as BCCs or SCCs. The accuracy of the clinical diagnoses was determined by comparison to the histologic subtype identified via biopsy of the lesion. Although the use of a dermatoscope during the clinical encounter was not formally recorded, reports from the examining dermatologists indicated it was not used in the majority of cases.

If a lesion was clinically diagnosed as a BCC but was identified as a subtype of SCC on histology (or vice versa), the lesion was considered to be mismatched. The number of mismatched lesions and the mismatch rate for each lesion type/subtype is recorded in the Table. Of the total 11,145 keratinocyte carcinomas included in our study, there was an overall 10.63% mismatch rate, with 1185 of the malignancies having a differing clinical diagnosis (eg, BCC vs SCC) from the histologic findings. The clinical mismatch rate was notably higher for SCC compared to BCC (15.83% vs 7.03%, respectively).

CT115005162-Table

The Table provides a breakdown of the BCC subtypes identified by histology with their computed mismatch rate and PPV. It is worth clarifying that lesions classified as more than one BCC subtype per the histologic findings were diagnosed as mixed BCC; these were further classified as mixed-aggressive BCC (if at least one aggressive BCC subtype was present) and mixed nonaggressive BCC (if no aggressive BCC subtype was present). Overall, BCCs were less likely to be misdiagnosed, with an average PPV of 92.97% compared to 84.17% for SCCs. Basosquamous BCC was the BCC subtype with the highest mismatch rate (25.48%), while sclerosing BCC has the lowest overall mismatch rate (1.33%). The most common malignancy was BCC, with nodular BCC being the most common subtype.

The Table also breaks down the SCC subtypes, reporting the most commonly misdiagnosed of any BCC or SCC subtype to be poorly differentiated SCC (mismatch rate, 38.46%). The lowest mismatch rate of the SCC subtypes was 5.97% for well-differentiated SCC.

There was an overall PPV of 89.37% in clinically evaluated malignancies and their respective histologic subtypes. Basal cell carcinoma had a lower overall mismatch rate of 7.03% compared to 15.83% in SCC. The most common misdiagnosis was attributed to poorly differentiated SCC (mismatch rate, 38.46%), while the least common misdiagnosed malignancy was sclerosing BCC (1.33%). The high mismatch rate of poorly differentiated SCC may be due to its diverging presentation from a typical SCC as a flat lesion with the absence of scaling, keratin, or bleeding, leading to the misdiagnosis of BCC.2

Accurate clinical diagnosis of NMSCs is the basis for further evaluation and treatment that should ensue in a timely manner; however, accurately identifying BCCs vs SCCs solely based on clinical examination can be challenging due to variable manifestations and overlapping features. Basal cell carcinoma commonly presents as a shiny pink/flesh-colored nodule, macule, or patch with surface telangiectasia, sometimes appearing with ulceration or crusting.3 Alternatively, SCC typically appears as a firm, sharply demarcated, red nodule with a thick overlying scale.4 Definitive diagnoses can be difficult upon clinical examination since these features can be shared between the 2 subtypes. To aid in these uncertainties, a growing number of clinicians are implementing the use of dermoscopy in their everyday practice.

Dermoscopy is an extremely useful tool in improving the diagnostic accuracy of skin cancers compared to examination with the naked eye, as it provides detailed visualization of specific structures and patterns in skin cancer lesions.5 The dermoscopic appearance of BCC is characterized by pearly blue-gray or translucent globules with arborizing vessels, spoke-wheel structures, and leaflike areas.5,6 Conversely, dermoscopic features of SCC may include a milky-red globule with a scaly, sharply demarcated, crusted lesion with polymorphous vasculature, sometimes resembling a persistent sore or nonhealing wound.4,5 Though the use of dermoscopy can aid in diagnosis upon initial examination, certain factors such as trauma, ulceration, and previous treatments that distorted the lesion’s architecture may lead to misdiagnosis. Furthermore, the distinct vascular patterns found in BCC and SCC may be mistaken for each other and therefore lead to misdiagnosis upon examination.7 Other variables that may complicate diagnosis include the location of the lesion, its size, and the presence of other skin conditions or nearby lesions.

The primary limitation of the current study was the limited scope of the data, as they were derived from patients seen at one private dermatology practice, preventing the generalizability of our findings. However, our results show trends similar to those observed in other studies analyzing the clinical accuracy of skin cancer diagnoses, with higher PPVs for BCC compared to SCC. A study by Ahnlide and Bjellerup8 was based in a hospital dermatology department and demonstrated a PPV of 85.5% for BCC compared to 92.97% in our study; for SCC, the PPV was 67.3% compared to 84.17% in our study. In another study by Heal et al,9 data were collected from an Australian registry that included records of all histologically confirmed skin cancers from December 1996 to October 1999 from 202 general practitioners and 42 specialists, including 1 dermatologist. The PPVs for BCC and SCC were 72.7% and 49.4%, respectively. Although our results indicated higher PPVs compared to these 2 studies, some of the discrepancies can be accounted for by the differences in clinical setting as well as the lack of expertise of nondermatologist physicians in identifying skin malignancies in the study by Heal et al.9

The current study was further limited by the lack of data quantifying the number of lesions clinically suspected to be malignant but found to be histologically benign. It is typical for clinicians to have a low threshold to biopsy a suspicious lesion with atypical features (eg, rapid evolution and growth, bleeding, crusting). Furthermore, the identification of risk factors in the patient’s medical and family history (eg, exposure to radiation, personal or family history of skin cancers) can heavily influence a clinician’s decision to biopsy a lesion with an atypical appearance.10 Many benign lesions are biopsied to avoid missing a diagnosis of malignancy. Consequently, our results suggest a high degree of clinical misdiagnosis of BCCs and SCCs. Obtaining data on the number of lesions suspected to be BCC or SCC that were found to be histologically benign would be a valuable addition to our study, as it would provide a measurable insight into the sensitivity of clinicians’ decision-making to identify a lesion as suspicious and warranting biopsy.

While clinical diagnosis plays a vital role in identifying suspected NMSCs such as BCC and SCC, its accuracy can be limited even with the use of dermoscopy. Overall, our data have shown a high rate of diagnostic accuracy upon suspicion of malignancy, but the different variables that affect clinical presentation promote histologic diagnosis to prevail as the gold standard.

References
  1. Seyed Ahadi M, Firooz A, Rahimi H, et al. Clinical diagnosis has a high negative predictive value in evaluation of malignant skin lesions. Dermatol Res Pract. 2021;2021:6618990. doi:10.1155/2021/6618990
  2. Lallas A, Pyne J, Kyrgidis A, et al. The clinical and dermoscopic features of invasive cutaneous squamous cell carcinoma depend on the histopathological grade of differentiation. Br J Dermatol. 2015;172:1308- 1315. doi:10.1111/bjd.13510
  3. McDaniel B, Badri T, Steele RB. Basal cell carcinoma. September 19, 2022. In: StatPearls. StatPearls Publishing; 2023.
  4. Suárez AL, Louis P, Kitts J, et al. Clinical and dermoscopic features of combined cutaneous squamous cell carcinoma (SCC)/neuroendocrine [Merkel cell] carcinoma (MCC). J Am Acad Dermatol. 2015;73:968-975. doi:10.1016/j.jaad.2015.08.041
  5. Wolner ZJ, Yélamos O, Liopyris K, et al. Enhancing skin cancer diagnosis with dermoscopy. Dermatol Clin. 2017;35:417-437. doi:10.1016/j.det.2017.06.003
  6. Reiter O, Mimouni I, Dusza S, et al. Dermoscopic features of basal cell carcinoma and its subtypes: a systematic review. J Am Acad Dermatol. 2021;85:653-664. doi:10.1016/j.jaad.2019.11.008
  7. Pruneda C, Ramesh M, Hope L, et al. Nonmelanoma skin cancers: diagnostic accuracy of midlevel providers versus dermatologists. The Dermatologist. March 2023. Accessed March 18, 2025. https://www.hmpgloballearningnetwork.com/site/thederm/feature-story/nonmelanoma-skin-cancers-diagnostic-accuracy-midlevel-providers-vs
  8. Ahnlide I, Bjellerup M. Accuracy of clinical skin tumour diagnosis in a dermatological setting. Acta Derm Venereol. 2013;93:305-308. doi:10.2340/00015555-1560
  9. Heal CF, Raasch BA, Buettner PG, et al. Accuracy of clinical diagnosis of skin lesions. Br J Dermatol. 2008;159:661-668.
  10. Fu S, Kim S, Wasko C. Dermatological guide for primary care physicians: full body skin checks, skin cancer detection, and patient education on self-skin checks and sun protection. Proc (Bayl Univ Med Cent). 2024;37:647-654. doi:10.1080/08998280.2024.2351751
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Maryam Niazi is from the School of Medicine, Texas Tech University Health Sciences Center, Lubbock. Dr. R.H. Hope is from Lubbock Dermatology and Skin Cancer Center, Texas. Dr. L. Hope is from the Department of Dermatology, University of Arkansas for Medical Sciences, Little Rock.

The authors have no relevant financial disclosures to report.

Correspondence: Maryam Niazi, BSA, 3601 4th St, Lubbock, TX, 79430 (Maryam.Niazi@ttuhsc.edu).

Cutis. 2024 May;115(5):162-164. doi:10.12788/cutis.1204

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Maryam Niazi is from the School of Medicine, Texas Tech University Health Sciences Center, Lubbock. Dr. R.H. Hope is from Lubbock Dermatology and Skin Cancer Center, Texas. Dr. L. Hope is from the Department of Dermatology, University of Arkansas for Medical Sciences, Little Rock.

The authors have no relevant financial disclosures to report.

Correspondence: Maryam Niazi, BSA, 3601 4th St, Lubbock, TX, 79430 (Maryam.Niazi@ttuhsc.edu).

Cutis. 2024 May;115(5):162-164. doi:10.12788/cutis.1204

Author and Disclosure Information

Maryam Niazi is from the School of Medicine, Texas Tech University Health Sciences Center, Lubbock. Dr. R.H. Hope is from Lubbock Dermatology and Skin Cancer Center, Texas. Dr. L. Hope is from the Department of Dermatology, University of Arkansas for Medical Sciences, Little Rock.

The authors have no relevant financial disclosures to report.

Correspondence: Maryam Niazi, BSA, 3601 4th St, Lubbock, TX, 79430 (Maryam.Niazi@ttuhsc.edu).

Cutis. 2024 May;115(5):162-164. doi:10.12788/cutis.1204

Article PDF
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To the Editor:

The incidence of nonmelanoma skin cancer (NMSC) is rapidly increasing worldwide. Due to its highly curable nature when treated early, accurate diagnosis is the cornerstone to good patient outcomes.1 Accurate diagnosis of skin cancer and subsequent treatment decisions rely heavily on the congruence between clinical observations and histopathologic assessments. Clinical misdiagnosis of a malignant lesion can lead to delayed and suboptimal treatment, which may contribute to serious complications such as metastasis or even mortality. In this study, data from clinically diagnosed basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs) were compared to their identified histopathologic subtype classifications. The accuracy of the clinical diagnosis of these NMSCs was assessed by determining the rate of misdiagnosis and the respective positive predictive value (PPV).

A retrospective review of medical records from a private dermatology practice in Lubbock, Texas, was conducted to identify patients diagnosed with NMSC from January 1, 2017, through December 31, 2021. A total of 11,229 NMSCs were diagnosed and treated in 5877 patients. Of the NMSCs diagnosed, 11,145 were identified as keratinocyte carcinomas and were classified as BCCs or SCCs. The accuracy of the clinical diagnoses was determined by comparison to the histologic subtype identified via biopsy of the lesion. Although the use of a dermatoscope during the clinical encounter was not formally recorded, reports from the examining dermatologists indicated it was not used in the majority of cases.

If a lesion was clinically diagnosed as a BCC but was identified as a subtype of SCC on histology (or vice versa), the lesion was considered to be mismatched. The number of mismatched lesions and the mismatch rate for each lesion type/subtype is recorded in the Table. Of the total 11,145 keratinocyte carcinomas included in our study, there was an overall 10.63% mismatch rate, with 1185 of the malignancies having a differing clinical diagnosis (eg, BCC vs SCC) from the histologic findings. The clinical mismatch rate was notably higher for SCC compared to BCC (15.83% vs 7.03%, respectively).

CT115005162-Table

The Table provides a breakdown of the BCC subtypes identified by histology with their computed mismatch rate and PPV. It is worth clarifying that lesions classified as more than one BCC subtype per the histologic findings were diagnosed as mixed BCC; these were further classified as mixed-aggressive BCC (if at least one aggressive BCC subtype was present) and mixed nonaggressive BCC (if no aggressive BCC subtype was present). Overall, BCCs were less likely to be misdiagnosed, with an average PPV of 92.97% compared to 84.17% for SCCs. Basosquamous BCC was the BCC subtype with the highest mismatch rate (25.48%), while sclerosing BCC has the lowest overall mismatch rate (1.33%). The most common malignancy was BCC, with nodular BCC being the most common subtype.

The Table also breaks down the SCC subtypes, reporting the most commonly misdiagnosed of any BCC or SCC subtype to be poorly differentiated SCC (mismatch rate, 38.46%). The lowest mismatch rate of the SCC subtypes was 5.97% for well-differentiated SCC.

There was an overall PPV of 89.37% in clinically evaluated malignancies and their respective histologic subtypes. Basal cell carcinoma had a lower overall mismatch rate of 7.03% compared to 15.83% in SCC. The most common misdiagnosis was attributed to poorly differentiated SCC (mismatch rate, 38.46%), while the least common misdiagnosed malignancy was sclerosing BCC (1.33%). The high mismatch rate of poorly differentiated SCC may be due to its diverging presentation from a typical SCC as a flat lesion with the absence of scaling, keratin, or bleeding, leading to the misdiagnosis of BCC.2

Accurate clinical diagnosis of NMSCs is the basis for further evaluation and treatment that should ensue in a timely manner; however, accurately identifying BCCs vs SCCs solely based on clinical examination can be challenging due to variable manifestations and overlapping features. Basal cell carcinoma commonly presents as a shiny pink/flesh-colored nodule, macule, or patch with surface telangiectasia, sometimes appearing with ulceration or crusting.3 Alternatively, SCC typically appears as a firm, sharply demarcated, red nodule with a thick overlying scale.4 Definitive diagnoses can be difficult upon clinical examination since these features can be shared between the 2 subtypes. To aid in these uncertainties, a growing number of clinicians are implementing the use of dermoscopy in their everyday practice.

Dermoscopy is an extremely useful tool in improving the diagnostic accuracy of skin cancers compared to examination with the naked eye, as it provides detailed visualization of specific structures and patterns in skin cancer lesions.5 The dermoscopic appearance of BCC is characterized by pearly blue-gray or translucent globules with arborizing vessels, spoke-wheel structures, and leaflike areas.5,6 Conversely, dermoscopic features of SCC may include a milky-red globule with a scaly, sharply demarcated, crusted lesion with polymorphous vasculature, sometimes resembling a persistent sore or nonhealing wound.4,5 Though the use of dermoscopy can aid in diagnosis upon initial examination, certain factors such as trauma, ulceration, and previous treatments that distorted the lesion’s architecture may lead to misdiagnosis. Furthermore, the distinct vascular patterns found in BCC and SCC may be mistaken for each other and therefore lead to misdiagnosis upon examination.7 Other variables that may complicate diagnosis include the location of the lesion, its size, and the presence of other skin conditions or nearby lesions.

The primary limitation of the current study was the limited scope of the data, as they were derived from patients seen at one private dermatology practice, preventing the generalizability of our findings. However, our results show trends similar to those observed in other studies analyzing the clinical accuracy of skin cancer diagnoses, with higher PPVs for BCC compared to SCC. A study by Ahnlide and Bjellerup8 was based in a hospital dermatology department and demonstrated a PPV of 85.5% for BCC compared to 92.97% in our study; for SCC, the PPV was 67.3% compared to 84.17% in our study. In another study by Heal et al,9 data were collected from an Australian registry that included records of all histologically confirmed skin cancers from December 1996 to October 1999 from 202 general practitioners and 42 specialists, including 1 dermatologist. The PPVs for BCC and SCC were 72.7% and 49.4%, respectively. Although our results indicated higher PPVs compared to these 2 studies, some of the discrepancies can be accounted for by the differences in clinical setting as well as the lack of expertise of nondermatologist physicians in identifying skin malignancies in the study by Heal et al.9

The current study was further limited by the lack of data quantifying the number of lesions clinically suspected to be malignant but found to be histologically benign. It is typical for clinicians to have a low threshold to biopsy a suspicious lesion with atypical features (eg, rapid evolution and growth, bleeding, crusting). Furthermore, the identification of risk factors in the patient’s medical and family history (eg, exposure to radiation, personal or family history of skin cancers) can heavily influence a clinician’s decision to biopsy a lesion with an atypical appearance.10 Many benign lesions are biopsied to avoid missing a diagnosis of malignancy. Consequently, our results suggest a high degree of clinical misdiagnosis of BCCs and SCCs. Obtaining data on the number of lesions suspected to be BCC or SCC that were found to be histologically benign would be a valuable addition to our study, as it would provide a measurable insight into the sensitivity of clinicians’ decision-making to identify a lesion as suspicious and warranting biopsy.

While clinical diagnosis plays a vital role in identifying suspected NMSCs such as BCC and SCC, its accuracy can be limited even with the use of dermoscopy. Overall, our data have shown a high rate of diagnostic accuracy upon suspicion of malignancy, but the different variables that affect clinical presentation promote histologic diagnosis to prevail as the gold standard.

To the Editor:

The incidence of nonmelanoma skin cancer (NMSC) is rapidly increasing worldwide. Due to its highly curable nature when treated early, accurate diagnosis is the cornerstone to good patient outcomes.1 Accurate diagnosis of skin cancer and subsequent treatment decisions rely heavily on the congruence between clinical observations and histopathologic assessments. Clinical misdiagnosis of a malignant lesion can lead to delayed and suboptimal treatment, which may contribute to serious complications such as metastasis or even mortality. In this study, data from clinically diagnosed basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs) were compared to their identified histopathologic subtype classifications. The accuracy of the clinical diagnosis of these NMSCs was assessed by determining the rate of misdiagnosis and the respective positive predictive value (PPV).

A retrospective review of medical records from a private dermatology practice in Lubbock, Texas, was conducted to identify patients diagnosed with NMSC from January 1, 2017, through December 31, 2021. A total of 11,229 NMSCs were diagnosed and treated in 5877 patients. Of the NMSCs diagnosed, 11,145 were identified as keratinocyte carcinomas and were classified as BCCs or SCCs. The accuracy of the clinical diagnoses was determined by comparison to the histologic subtype identified via biopsy of the lesion. Although the use of a dermatoscope during the clinical encounter was not formally recorded, reports from the examining dermatologists indicated it was not used in the majority of cases.

If a lesion was clinically diagnosed as a BCC but was identified as a subtype of SCC on histology (or vice versa), the lesion was considered to be mismatched. The number of mismatched lesions and the mismatch rate for each lesion type/subtype is recorded in the Table. Of the total 11,145 keratinocyte carcinomas included in our study, there was an overall 10.63% mismatch rate, with 1185 of the malignancies having a differing clinical diagnosis (eg, BCC vs SCC) from the histologic findings. The clinical mismatch rate was notably higher for SCC compared to BCC (15.83% vs 7.03%, respectively).

CT115005162-Table

The Table provides a breakdown of the BCC subtypes identified by histology with their computed mismatch rate and PPV. It is worth clarifying that lesions classified as more than one BCC subtype per the histologic findings were diagnosed as mixed BCC; these were further classified as mixed-aggressive BCC (if at least one aggressive BCC subtype was present) and mixed nonaggressive BCC (if no aggressive BCC subtype was present). Overall, BCCs were less likely to be misdiagnosed, with an average PPV of 92.97% compared to 84.17% for SCCs. Basosquamous BCC was the BCC subtype with the highest mismatch rate (25.48%), while sclerosing BCC has the lowest overall mismatch rate (1.33%). The most common malignancy was BCC, with nodular BCC being the most common subtype.

The Table also breaks down the SCC subtypes, reporting the most commonly misdiagnosed of any BCC or SCC subtype to be poorly differentiated SCC (mismatch rate, 38.46%). The lowest mismatch rate of the SCC subtypes was 5.97% for well-differentiated SCC.

There was an overall PPV of 89.37% in clinically evaluated malignancies and their respective histologic subtypes. Basal cell carcinoma had a lower overall mismatch rate of 7.03% compared to 15.83% in SCC. The most common misdiagnosis was attributed to poorly differentiated SCC (mismatch rate, 38.46%), while the least common misdiagnosed malignancy was sclerosing BCC (1.33%). The high mismatch rate of poorly differentiated SCC may be due to its diverging presentation from a typical SCC as a flat lesion with the absence of scaling, keratin, or bleeding, leading to the misdiagnosis of BCC.2

Accurate clinical diagnosis of NMSCs is the basis for further evaluation and treatment that should ensue in a timely manner; however, accurately identifying BCCs vs SCCs solely based on clinical examination can be challenging due to variable manifestations and overlapping features. Basal cell carcinoma commonly presents as a shiny pink/flesh-colored nodule, macule, or patch with surface telangiectasia, sometimes appearing with ulceration or crusting.3 Alternatively, SCC typically appears as a firm, sharply demarcated, red nodule with a thick overlying scale.4 Definitive diagnoses can be difficult upon clinical examination since these features can be shared between the 2 subtypes. To aid in these uncertainties, a growing number of clinicians are implementing the use of dermoscopy in their everyday practice.

Dermoscopy is an extremely useful tool in improving the diagnostic accuracy of skin cancers compared to examination with the naked eye, as it provides detailed visualization of specific structures and patterns in skin cancer lesions.5 The dermoscopic appearance of BCC is characterized by pearly blue-gray or translucent globules with arborizing vessels, spoke-wheel structures, and leaflike areas.5,6 Conversely, dermoscopic features of SCC may include a milky-red globule with a scaly, sharply demarcated, crusted lesion with polymorphous vasculature, sometimes resembling a persistent sore or nonhealing wound.4,5 Though the use of dermoscopy can aid in diagnosis upon initial examination, certain factors such as trauma, ulceration, and previous treatments that distorted the lesion’s architecture may lead to misdiagnosis. Furthermore, the distinct vascular patterns found in BCC and SCC may be mistaken for each other and therefore lead to misdiagnosis upon examination.7 Other variables that may complicate diagnosis include the location of the lesion, its size, and the presence of other skin conditions or nearby lesions.

The primary limitation of the current study was the limited scope of the data, as they were derived from patients seen at one private dermatology practice, preventing the generalizability of our findings. However, our results show trends similar to those observed in other studies analyzing the clinical accuracy of skin cancer diagnoses, with higher PPVs for BCC compared to SCC. A study by Ahnlide and Bjellerup8 was based in a hospital dermatology department and demonstrated a PPV of 85.5% for BCC compared to 92.97% in our study; for SCC, the PPV was 67.3% compared to 84.17% in our study. In another study by Heal et al,9 data were collected from an Australian registry that included records of all histologically confirmed skin cancers from December 1996 to October 1999 from 202 general practitioners and 42 specialists, including 1 dermatologist. The PPVs for BCC and SCC were 72.7% and 49.4%, respectively. Although our results indicated higher PPVs compared to these 2 studies, some of the discrepancies can be accounted for by the differences in clinical setting as well as the lack of expertise of nondermatologist physicians in identifying skin malignancies in the study by Heal et al.9

The current study was further limited by the lack of data quantifying the number of lesions clinically suspected to be malignant but found to be histologically benign. It is typical for clinicians to have a low threshold to biopsy a suspicious lesion with atypical features (eg, rapid evolution and growth, bleeding, crusting). Furthermore, the identification of risk factors in the patient’s medical and family history (eg, exposure to radiation, personal or family history of skin cancers) can heavily influence a clinician’s decision to biopsy a lesion with an atypical appearance.10 Many benign lesions are biopsied to avoid missing a diagnosis of malignancy. Consequently, our results suggest a high degree of clinical misdiagnosis of BCCs and SCCs. Obtaining data on the number of lesions suspected to be BCC or SCC that were found to be histologically benign would be a valuable addition to our study, as it would provide a measurable insight into the sensitivity of clinicians’ decision-making to identify a lesion as suspicious and warranting biopsy.

While clinical diagnosis plays a vital role in identifying suspected NMSCs such as BCC and SCC, its accuracy can be limited even with the use of dermoscopy. Overall, our data have shown a high rate of diagnostic accuracy upon suspicion of malignancy, but the different variables that affect clinical presentation promote histologic diagnosis to prevail as the gold standard.

References
  1. Seyed Ahadi M, Firooz A, Rahimi H, et al. Clinical diagnosis has a high negative predictive value in evaluation of malignant skin lesions. Dermatol Res Pract. 2021;2021:6618990. doi:10.1155/2021/6618990
  2. Lallas A, Pyne J, Kyrgidis A, et al. The clinical and dermoscopic features of invasive cutaneous squamous cell carcinoma depend on the histopathological grade of differentiation. Br J Dermatol. 2015;172:1308- 1315. doi:10.1111/bjd.13510
  3. McDaniel B, Badri T, Steele RB. Basal cell carcinoma. September 19, 2022. In: StatPearls. StatPearls Publishing; 2023.
  4. Suárez AL, Louis P, Kitts J, et al. Clinical and dermoscopic features of combined cutaneous squamous cell carcinoma (SCC)/neuroendocrine [Merkel cell] carcinoma (MCC). J Am Acad Dermatol. 2015;73:968-975. doi:10.1016/j.jaad.2015.08.041
  5. Wolner ZJ, Yélamos O, Liopyris K, et al. Enhancing skin cancer diagnosis with dermoscopy. Dermatol Clin. 2017;35:417-437. doi:10.1016/j.det.2017.06.003
  6. Reiter O, Mimouni I, Dusza S, et al. Dermoscopic features of basal cell carcinoma and its subtypes: a systematic review. J Am Acad Dermatol. 2021;85:653-664. doi:10.1016/j.jaad.2019.11.008
  7. Pruneda C, Ramesh M, Hope L, et al. Nonmelanoma skin cancers: diagnostic accuracy of midlevel providers versus dermatologists. The Dermatologist. March 2023. Accessed March 18, 2025. https://www.hmpgloballearningnetwork.com/site/thederm/feature-story/nonmelanoma-skin-cancers-diagnostic-accuracy-midlevel-providers-vs
  8. Ahnlide I, Bjellerup M. Accuracy of clinical skin tumour diagnosis in a dermatological setting. Acta Derm Venereol. 2013;93:305-308. doi:10.2340/00015555-1560
  9. Heal CF, Raasch BA, Buettner PG, et al. Accuracy of clinical diagnosis of skin lesions. Br J Dermatol. 2008;159:661-668.
  10. Fu S, Kim S, Wasko C. Dermatological guide for primary care physicians: full body skin checks, skin cancer detection, and patient education on self-skin checks and sun protection. Proc (Bayl Univ Med Cent). 2024;37:647-654. doi:10.1080/08998280.2024.2351751
References
  1. Seyed Ahadi M, Firooz A, Rahimi H, et al. Clinical diagnosis has a high negative predictive value in evaluation of malignant skin lesions. Dermatol Res Pract. 2021;2021:6618990. doi:10.1155/2021/6618990
  2. Lallas A, Pyne J, Kyrgidis A, et al. The clinical and dermoscopic features of invasive cutaneous squamous cell carcinoma depend on the histopathological grade of differentiation. Br J Dermatol. 2015;172:1308- 1315. doi:10.1111/bjd.13510
  3. McDaniel B, Badri T, Steele RB. Basal cell carcinoma. September 19, 2022. In: StatPearls. StatPearls Publishing; 2023.
  4. Suárez AL, Louis P, Kitts J, et al. Clinical and dermoscopic features of combined cutaneous squamous cell carcinoma (SCC)/neuroendocrine [Merkel cell] carcinoma (MCC). J Am Acad Dermatol. 2015;73:968-975. doi:10.1016/j.jaad.2015.08.041
  5. Wolner ZJ, Yélamos O, Liopyris K, et al. Enhancing skin cancer diagnosis with dermoscopy. Dermatol Clin. 2017;35:417-437. doi:10.1016/j.det.2017.06.003
  6. Reiter O, Mimouni I, Dusza S, et al. Dermoscopic features of basal cell carcinoma and its subtypes: a systematic review. J Am Acad Dermatol. 2021;85:653-664. doi:10.1016/j.jaad.2019.11.008
  7. Pruneda C, Ramesh M, Hope L, et al. Nonmelanoma skin cancers: diagnostic accuracy of midlevel providers versus dermatologists. The Dermatologist. March 2023. Accessed March 18, 2025. https://www.hmpgloballearningnetwork.com/site/thederm/feature-story/nonmelanoma-skin-cancers-diagnostic-accuracy-midlevel-providers-vs
  8. Ahnlide I, Bjellerup M. Accuracy of clinical skin tumour diagnosis in a dermatological setting. Acta Derm Venereol. 2013;93:305-308. doi:10.2340/00015555-1560
  9. Heal CF, Raasch BA, Buettner PG, et al. Accuracy of clinical diagnosis of skin lesions. Br J Dermatol. 2008;159:661-668.
  10. Fu S, Kim S, Wasko C. Dermatological guide for primary care physicians: full body skin checks, skin cancer detection, and patient education on self-skin checks and sun protection. Proc (Bayl Univ Med Cent). 2024;37:647-654. doi:10.1080/08998280.2024.2351751
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Clinical Accuracy of Skin Cancer Diagnosis: Investigation of Keratinocyte Carcinoma Mismatch Rates

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Clinical Accuracy of Skin Cancer Diagnosis: Investigation of Keratinocyte Carcinoma Mismatch Rates

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  • Malignant lesions may be misdiagnosed when assessments are guided by clinical features that align with typical presentations of other lesion types, potentially leading to diagnostic errors among experienced clinicians.
  • Although dermoscopy is a beneficial tool in examining potential skin cancers, clinical observations should not bypass the gold standard of histopathologic examination.
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