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In-Depth Look at a Community- Based Population of Multiple Myeloma (MM) Patients Undergoing an in-Class Transition (iCT) from Parenteral Bortezomib to Oral Ixazomib in the United States (US) MM-6 Study
BACKGROUND: Randomized clinical trials (RCTs) typically enroll highly selected populations. Oncology RCTs have an average of 16 eligibility criteria (Unger JNCI 2014). Registry analyses indicate that up to ~40% of ‘real-world’ MM patients are ineligible for RCTs based on common criteria (Shah CLML 2017).
PURPOSE: US MM-6 (NCT03173092) is evaluating iCT from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) in MM patients treated at US community oncology centers. Eligibility criteria are less stringent than RCTs, to enroll patients more representative of the real-world MM population.
METHODS: Non-transplant-eligible newly-diagnosed MM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at 22 US community sites (including three Veterans Affairs hospitals) to receive ixazomib-Rd for up to 39 28- day cycles or until progression/toxicity.
DATA ANALYSIS: We reviewed 84 consecutively enrolled patients using standard RCT eligibility criteria. Initially, six criteria were explored to determine the proportion of patients who might have been RCT-ineligible: renal dysfunction, congestive heart failure (CHF), stroke, prior malignancies, chronic obstructive pulmonary disease (COPD), and memory loss. Dosing information was evaluated to determine any correlation between dose modifications and eligibility status.
RESULTS: Based on six criteria, 24/84 patients (29%) may have been RCT-ineligible: 12% (n=10) had renal dysfunction, 7% (n=6) CHF, 6% (n=5) stroke, 5% (n=4) each other prior malignancies and COPD, and 2% (n=2) memory loss; 6% (n=5) had >1 criterion. Among the 24 RCT-ineligible patients, 75% (n=18), 42% (n=10), and 54% (n=13) received the highest starting doses of ixazomib (4mg), lenalidomide (25mg), and dexamethasone (40mg), respectively. Ixazomib, lenalidomide, and dexamethasone dose reductions were required in 29% (n=7), 25% (n=6), and 21% (n=5), respectively (due to adverse events [AEs]: 21% [n=5], 21% [n=5], 4% [n=1]). 50% (n=12) discontinued treatment (consent withdrawal/patient decision, n=7; disease progression, n=2; sufficient response, AE, death, each n=1); n=3/2/2 discontinued ixazomib/lenalidomide/ dexamethasone due to AEs.
IMPLICATIONS: US MM-6 is enrolling real-world, community- based MM patients, including those who may be ineligible for RCTs based on standard inclusion criteria. Our analysis indicates that iCT to ixazomib- Rd appears to be feasible in these RCT-ineligible US MM-6 patients. Further criteria will be analyzed and presented.
BACKGROUND: Randomized clinical trials (RCTs) typically enroll highly selected populations. Oncology RCTs have an average of 16 eligibility criteria (Unger JNCI 2014). Registry analyses indicate that up to ~40% of ‘real-world’ MM patients are ineligible for RCTs based on common criteria (Shah CLML 2017).
PURPOSE: US MM-6 (NCT03173092) is evaluating iCT from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) in MM patients treated at US community oncology centers. Eligibility criteria are less stringent than RCTs, to enroll patients more representative of the real-world MM population.
METHODS: Non-transplant-eligible newly-diagnosed MM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at 22 US community sites (including three Veterans Affairs hospitals) to receive ixazomib-Rd for up to 39 28- day cycles or until progression/toxicity.
DATA ANALYSIS: We reviewed 84 consecutively enrolled patients using standard RCT eligibility criteria. Initially, six criteria were explored to determine the proportion of patients who might have been RCT-ineligible: renal dysfunction, congestive heart failure (CHF), stroke, prior malignancies, chronic obstructive pulmonary disease (COPD), and memory loss. Dosing information was evaluated to determine any correlation between dose modifications and eligibility status.
RESULTS: Based on six criteria, 24/84 patients (29%) may have been RCT-ineligible: 12% (n=10) had renal dysfunction, 7% (n=6) CHF, 6% (n=5) stroke, 5% (n=4) each other prior malignancies and COPD, and 2% (n=2) memory loss; 6% (n=5) had >1 criterion. Among the 24 RCT-ineligible patients, 75% (n=18), 42% (n=10), and 54% (n=13) received the highest starting doses of ixazomib (4mg), lenalidomide (25mg), and dexamethasone (40mg), respectively. Ixazomib, lenalidomide, and dexamethasone dose reductions were required in 29% (n=7), 25% (n=6), and 21% (n=5), respectively (due to adverse events [AEs]: 21% [n=5], 21% [n=5], 4% [n=1]). 50% (n=12) discontinued treatment (consent withdrawal/patient decision, n=7; disease progression, n=2; sufficient response, AE, death, each n=1); n=3/2/2 discontinued ixazomib/lenalidomide/ dexamethasone due to AEs.
IMPLICATIONS: US MM-6 is enrolling real-world, community- based MM patients, including those who may be ineligible for RCTs based on standard inclusion criteria. Our analysis indicates that iCT to ixazomib- Rd appears to be feasible in these RCT-ineligible US MM-6 patients. Further criteria will be analyzed and presented.
BACKGROUND: Randomized clinical trials (RCTs) typically enroll highly selected populations. Oncology RCTs have an average of 16 eligibility criteria (Unger JNCI 2014). Registry analyses indicate that up to ~40% of ‘real-world’ MM patients are ineligible for RCTs based on common criteria (Shah CLML 2017).
PURPOSE: US MM-6 (NCT03173092) is evaluating iCT from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) in MM patients treated at US community oncology centers. Eligibility criteria are less stringent than RCTs, to enroll patients more representative of the real-world MM population.
METHODS: Non-transplant-eligible newly-diagnosed MM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at 22 US community sites (including three Veterans Affairs hospitals) to receive ixazomib-Rd for up to 39 28- day cycles or until progression/toxicity.
DATA ANALYSIS: We reviewed 84 consecutively enrolled patients using standard RCT eligibility criteria. Initially, six criteria were explored to determine the proportion of patients who might have been RCT-ineligible: renal dysfunction, congestive heart failure (CHF), stroke, prior malignancies, chronic obstructive pulmonary disease (COPD), and memory loss. Dosing information was evaluated to determine any correlation between dose modifications and eligibility status.
RESULTS: Based on six criteria, 24/84 patients (29%) may have been RCT-ineligible: 12% (n=10) had renal dysfunction, 7% (n=6) CHF, 6% (n=5) stroke, 5% (n=4) each other prior malignancies and COPD, and 2% (n=2) memory loss; 6% (n=5) had >1 criterion. Among the 24 RCT-ineligible patients, 75% (n=18), 42% (n=10), and 54% (n=13) received the highest starting doses of ixazomib (4mg), lenalidomide (25mg), and dexamethasone (40mg), respectively. Ixazomib, lenalidomide, and dexamethasone dose reductions were required in 29% (n=7), 25% (n=6), and 21% (n=5), respectively (due to adverse events [AEs]: 21% [n=5], 21% [n=5], 4% [n=1]). 50% (n=12) discontinued treatment (consent withdrawal/patient decision, n=7; disease progression, n=2; sufficient response, AE, death, each n=1); n=3/2/2 discontinued ixazomib/lenalidomide/ dexamethasone due to AEs.
IMPLICATIONS: US MM-6 is enrolling real-world, community- based MM patients, including those who may be ineligible for RCTs based on standard inclusion criteria. Our analysis indicates that iCT to ixazomib- Rd appears to be feasible in these RCT-ineligible US MM-6 patients. Further criteria will be analyzed and presented.
Effective Pain Control With Very Low Dose Palliative Radiotherapy for Multiple Myeloma Patients With Osseous Lesions
BACKGROUND: Osteolytic lesions are present in 75% of multiple myeloma (MM) patients and frequently require palliation with radiation therapy (RT). Case series of MM patients with bone pain undergoing palliative RT suggest doses > 12 Gy (EQD2) provide excellent bone pain relief. However, recent advances in novel biologic agents have significantly improved overall survival and quality of life for MM patients. We hypothesized that lower-dose RT (LDRT, EQD2 < 12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 > 12 Gy) for palliation of painful MM bone lesions.
METHODS: We retrospectively identified MM patients treated with RT for painful bone lesions and stratified by EQD2 < 12Gy versus ≥12Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 71 treated lesions were included: 24 patients (49 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow up was 16.8 months. The median dose of HDRT treatment was 20 Gy (range 8-30 Gy, EQD2 12- 32.5 Gy) versus 4 Gy in the LDRT group (range = 4-8 Gy, EQD2 4.67-9.3 Gy). The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any grade acute toxicity between the HDRT cohort and LDRT cohort (24.5% vs. 9.1%, χ2 P=0.20). Pain recurred in 10% of lesions (12% HDRT versus 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (p=0.91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort and 3 (6.3%) in the HDRT cohort.
CONCLUSIONS: In this study, LDRT effectively palliated painful MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful MM bony lesions.
BACKGROUND: Osteolytic lesions are present in 75% of multiple myeloma (MM) patients and frequently require palliation with radiation therapy (RT). Case series of MM patients with bone pain undergoing palliative RT suggest doses > 12 Gy (EQD2) provide excellent bone pain relief. However, recent advances in novel biologic agents have significantly improved overall survival and quality of life for MM patients. We hypothesized that lower-dose RT (LDRT, EQD2 < 12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 > 12 Gy) for palliation of painful MM bone lesions.
METHODS: We retrospectively identified MM patients treated with RT for painful bone lesions and stratified by EQD2 < 12Gy versus ≥12Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 71 treated lesions were included: 24 patients (49 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow up was 16.8 months. The median dose of HDRT treatment was 20 Gy (range 8-30 Gy, EQD2 12- 32.5 Gy) versus 4 Gy in the LDRT group (range = 4-8 Gy, EQD2 4.67-9.3 Gy). The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any grade acute toxicity between the HDRT cohort and LDRT cohort (24.5% vs. 9.1%, χ2 P=0.20). Pain recurred in 10% of lesions (12% HDRT versus 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (p=0.91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort and 3 (6.3%) in the HDRT cohort.
CONCLUSIONS: In this study, LDRT effectively palliated painful MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful MM bony lesions.
BACKGROUND: Osteolytic lesions are present in 75% of multiple myeloma (MM) patients and frequently require palliation with radiation therapy (RT). Case series of MM patients with bone pain undergoing palliative RT suggest doses > 12 Gy (EQD2) provide excellent bone pain relief. However, recent advances in novel biologic agents have significantly improved overall survival and quality of life for MM patients. We hypothesized that lower-dose RT (LDRT, EQD2 < 12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 > 12 Gy) for palliation of painful MM bone lesions.
METHODS: We retrospectively identified MM patients treated with RT for painful bone lesions and stratified by EQD2 < 12Gy versus ≥12Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 71 treated lesions were included: 24 patients (49 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow up was 16.8 months. The median dose of HDRT treatment was 20 Gy (range 8-30 Gy, EQD2 12- 32.5 Gy) versus 4 Gy in the LDRT group (range = 4-8 Gy, EQD2 4.67-9.3 Gy). The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any grade acute toxicity between the HDRT cohort and LDRT cohort (24.5% vs. 9.1%, χ2 P=0.20). Pain recurred in 10% of lesions (12% HDRT versus 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (p=0.91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort and 3 (6.3%) in the HDRT cohort.
CONCLUSIONS: In this study, LDRT effectively palliated painful MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful MM bony lesions.
Assessing Risk for and Management of Secondary CNS Involvement in Patients With DLBCL Within the Veterans Health Administration (VHA)
INTRODUCTION: In diffuse large B-cell lymphoma (DLBCL), approximately 5-10% of patients develop secondary central nervous system (CNS) involvement. CNS disease is associated with very poor outcomes. Therefore, it is important to identify patients at risk, via the CNS International Prognostic Index (IPI), in order to initiate appropriate interventions. Additional independent risk factors for CNS involvement include HIV-related lymphoma and high-grade B-cell lymphomas. The purpose of this study was to assess for appropriate CNS evaluation and prophylaxis in DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected patients seen in the VHA nationwide who were diagnosed with lymphoma between January 1, 2011 and December 31, 2017. We included patients diagnosed with DLBCL and excluded patients diagnosed or treated outside the VHA. We evaluated CNS IPI score, HIV status, pathology reports to identify high-grade lymphomas, performance of lumbar puncture (LP), and administration of CNS prophylaxis.
RESULTS: A total of 725 patients met our inclusion criteria. Patients were predominantly male (96.8%), white (74.5%), had a median age of 67, and presented with advanced disease (stage III 26.5%, stage IV 40.3%). From the included population, 190 (26.2%) had a highrisk CNS IPI score. Of those with high-risk CNS IPI scores, 64 (33.7%) underwent LP and 46 (24.2%) were treated with CNS prophylaxis. 23 (3.2%) were HIV positive; of those, 14 (60.8%) underwent LP and 4 (17.4%) were treated with CNS prophylaxis. FISH results were available in only 242 (33.4%) of patients and of these, 25 (10.3%) met criteria for high-grade lymphoma. Of those with high-grade lymphoma, 9 (36%) underwent LP and 7 (28%) were treated with CNS prophylaxis.
CONCLUSIONS: The National Comprehensive Cancer Network guidelines recommend that patients at high risk for CNS involvement undergo LP and treatment with CNS prophylaxis. This study found that within the VHA, patients with DLBCL at high risk for CNS involvement are not being evaluated with LPs or treated with CNS prophylaxis as often as indicated, based on CNS IPI, HIV status, and high-grade pathology. We demonstrate a need for improvement in the evaluation and treatment of these patients in order to improve outcomes.
INTRODUCTION: In diffuse large B-cell lymphoma (DLBCL), approximately 5-10% of patients develop secondary central nervous system (CNS) involvement. CNS disease is associated with very poor outcomes. Therefore, it is important to identify patients at risk, via the CNS International Prognostic Index (IPI), in order to initiate appropriate interventions. Additional independent risk factors for CNS involvement include HIV-related lymphoma and high-grade B-cell lymphomas. The purpose of this study was to assess for appropriate CNS evaluation and prophylaxis in DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected patients seen in the VHA nationwide who were diagnosed with lymphoma between January 1, 2011 and December 31, 2017. We included patients diagnosed with DLBCL and excluded patients diagnosed or treated outside the VHA. We evaluated CNS IPI score, HIV status, pathology reports to identify high-grade lymphomas, performance of lumbar puncture (LP), and administration of CNS prophylaxis.
RESULTS: A total of 725 patients met our inclusion criteria. Patients were predominantly male (96.8%), white (74.5%), had a median age of 67, and presented with advanced disease (stage III 26.5%, stage IV 40.3%). From the included population, 190 (26.2%) had a highrisk CNS IPI score. Of those with high-risk CNS IPI scores, 64 (33.7%) underwent LP and 46 (24.2%) were treated with CNS prophylaxis. 23 (3.2%) were HIV positive; of those, 14 (60.8%) underwent LP and 4 (17.4%) were treated with CNS prophylaxis. FISH results were available in only 242 (33.4%) of patients and of these, 25 (10.3%) met criteria for high-grade lymphoma. Of those with high-grade lymphoma, 9 (36%) underwent LP and 7 (28%) were treated with CNS prophylaxis.
CONCLUSIONS: The National Comprehensive Cancer Network guidelines recommend that patients at high risk for CNS involvement undergo LP and treatment with CNS prophylaxis. This study found that within the VHA, patients with DLBCL at high risk for CNS involvement are not being evaluated with LPs or treated with CNS prophylaxis as often as indicated, based on CNS IPI, HIV status, and high-grade pathology. We demonstrate a need for improvement in the evaluation and treatment of these patients in order to improve outcomes.
INTRODUCTION: In diffuse large B-cell lymphoma (DLBCL), approximately 5-10% of patients develop secondary central nervous system (CNS) involvement. CNS disease is associated with very poor outcomes. Therefore, it is important to identify patients at risk, via the CNS International Prognostic Index (IPI), in order to initiate appropriate interventions. Additional independent risk factors for CNS involvement include HIV-related lymphoma and high-grade B-cell lymphomas. The purpose of this study was to assess for appropriate CNS evaluation and prophylaxis in DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected patients seen in the VHA nationwide who were diagnosed with lymphoma between January 1, 2011 and December 31, 2017. We included patients diagnosed with DLBCL and excluded patients diagnosed or treated outside the VHA. We evaluated CNS IPI score, HIV status, pathology reports to identify high-grade lymphomas, performance of lumbar puncture (LP), and administration of CNS prophylaxis.
RESULTS: A total of 725 patients met our inclusion criteria. Patients were predominantly male (96.8%), white (74.5%), had a median age of 67, and presented with advanced disease (stage III 26.5%, stage IV 40.3%). From the included population, 190 (26.2%) had a highrisk CNS IPI score. Of those with high-risk CNS IPI scores, 64 (33.7%) underwent LP and 46 (24.2%) were treated with CNS prophylaxis. 23 (3.2%) were HIV positive; of those, 14 (60.8%) underwent LP and 4 (17.4%) were treated with CNS prophylaxis. FISH results were available in only 242 (33.4%) of patients and of these, 25 (10.3%) met criteria for high-grade lymphoma. Of those with high-grade lymphoma, 9 (36%) underwent LP and 7 (28%) were treated with CNS prophylaxis.
CONCLUSIONS: The National Comprehensive Cancer Network guidelines recommend that patients at high risk for CNS involvement undergo LP and treatment with CNS prophylaxis. This study found that within the VHA, patients with DLBCL at high risk for CNS involvement are not being evaluated with LPs or treated with CNS prophylaxis as often as indicated, based on CNS IPI, HIV status, and high-grade pathology. We demonstrate a need for improvement in the evaluation and treatment of these patients in order to improve outcomes.
A Single Center Experience of Immune Related Adverse Events From Immune Checkpoint Inhibitors and an Attempt to Identify Populations at High Risk
INTRODUCTION: American Society of Clinical Oncology (ASCO) has developed guidelines on the management of immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICPIs). However, many irAEs are under-reported and the studies to investigate predictive factors are limited with variable results.
METHODS: A total of 66 patients who received ICPIs at Stratton VAMC Albany between January 2015 to December 2018 were studied. Computerized Patient Record System (CPRS) was used to do a retrospective chart review to identify irAEs and related parameters. IRB approval was obtained.
RESULTS: Sixty-three patients received PD-1 inhibitors (62 males). Our study included 39 patients with lung, 10 renal, 6 head and neck, 4 skin (melanoma), and 2 bladder cancers, and 1 metastatic cancer with unknown primary. Median age of patients with irAEs was 69.5 years versus 66.7 years for patients without irAEs. 23 (36.5%) patients experienced 28 irAEs. 45 patients received nivolumab, 18 (40%) of which had 21 irAEs. 17 got pembrolizumab and 5 (35.2%) had 7 irAEs. Majority of the irAEs were grade I (n=10, 35.7%) or grade II (n=11, 39.2%), while 6 (21.4%) grade III and only 1 (3.5%) grade IV irAE was observed. Median time to appearance of irAEs was 2 cycles. Immunotherapy was continued in 12, temporarily held in 7 and permanently discontinued only in 4 patients. No death was attributed to irAEs. Six patients developed diarrhea, 4 hepatitis, 6 skin rash, 5 thyroid issues and 3 pneumonitis. Rare irAEs included cardiac tamponade (grade IV), uveitis (grade II), central adrenal insufficiency and mild neutropenia in one patient each. 2 patients had pre-existing autoimmune conditions (rheumatoid arthritis and chronic dermatitis), both had transient flares though immunotherapy was continued. Of note, only 3 patients received PDL-1 inhibitors and 1 developed grade II polymyalgia rheumatica and hypothyroidism.
Using multivariate logistic regression, we found no significant association between irAEs and age, body mass index, derived neutrophil to lymphocyte ratio, chronic kidney disease or environmental/medical allergies.
CONCLUSIONS: ICPIs were generally well tolerated in our population, though prompt recognition of rare and severe irAEs is essential. Larger studies are needed to investigate the predictive risk factors for irAEs.
INTRODUCTION: American Society of Clinical Oncology (ASCO) has developed guidelines on the management of immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICPIs). However, many irAEs are under-reported and the studies to investigate predictive factors are limited with variable results.
METHODS: A total of 66 patients who received ICPIs at Stratton VAMC Albany between January 2015 to December 2018 were studied. Computerized Patient Record System (CPRS) was used to do a retrospective chart review to identify irAEs and related parameters. IRB approval was obtained.
RESULTS: Sixty-three patients received PD-1 inhibitors (62 males). Our study included 39 patients with lung, 10 renal, 6 head and neck, 4 skin (melanoma), and 2 bladder cancers, and 1 metastatic cancer with unknown primary. Median age of patients with irAEs was 69.5 years versus 66.7 years for patients without irAEs. 23 (36.5%) patients experienced 28 irAEs. 45 patients received nivolumab, 18 (40%) of which had 21 irAEs. 17 got pembrolizumab and 5 (35.2%) had 7 irAEs. Majority of the irAEs were grade I (n=10, 35.7%) or grade II (n=11, 39.2%), while 6 (21.4%) grade III and only 1 (3.5%) grade IV irAE was observed. Median time to appearance of irAEs was 2 cycles. Immunotherapy was continued in 12, temporarily held in 7 and permanently discontinued only in 4 patients. No death was attributed to irAEs. Six patients developed diarrhea, 4 hepatitis, 6 skin rash, 5 thyroid issues and 3 pneumonitis. Rare irAEs included cardiac tamponade (grade IV), uveitis (grade II), central adrenal insufficiency and mild neutropenia in one patient each. 2 patients had pre-existing autoimmune conditions (rheumatoid arthritis and chronic dermatitis), both had transient flares though immunotherapy was continued. Of note, only 3 patients received PDL-1 inhibitors and 1 developed grade II polymyalgia rheumatica and hypothyroidism.
Using multivariate logistic regression, we found no significant association between irAEs and age, body mass index, derived neutrophil to lymphocyte ratio, chronic kidney disease or environmental/medical allergies.
CONCLUSIONS: ICPIs were generally well tolerated in our population, though prompt recognition of rare and severe irAEs is essential. Larger studies are needed to investigate the predictive risk factors for irAEs.
INTRODUCTION: American Society of Clinical Oncology (ASCO) has developed guidelines on the management of immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICPIs). However, many irAEs are under-reported and the studies to investigate predictive factors are limited with variable results.
METHODS: A total of 66 patients who received ICPIs at Stratton VAMC Albany between January 2015 to December 2018 were studied. Computerized Patient Record System (CPRS) was used to do a retrospective chart review to identify irAEs and related parameters. IRB approval was obtained.
RESULTS: Sixty-three patients received PD-1 inhibitors (62 males). Our study included 39 patients with lung, 10 renal, 6 head and neck, 4 skin (melanoma), and 2 bladder cancers, and 1 metastatic cancer with unknown primary. Median age of patients with irAEs was 69.5 years versus 66.7 years for patients without irAEs. 23 (36.5%) patients experienced 28 irAEs. 45 patients received nivolumab, 18 (40%) of which had 21 irAEs. 17 got pembrolizumab and 5 (35.2%) had 7 irAEs. Majority of the irAEs were grade I (n=10, 35.7%) or grade II (n=11, 39.2%), while 6 (21.4%) grade III and only 1 (3.5%) grade IV irAE was observed. Median time to appearance of irAEs was 2 cycles. Immunotherapy was continued in 12, temporarily held in 7 and permanently discontinued only in 4 patients. No death was attributed to irAEs. Six patients developed diarrhea, 4 hepatitis, 6 skin rash, 5 thyroid issues and 3 pneumonitis. Rare irAEs included cardiac tamponade (grade IV), uveitis (grade II), central adrenal insufficiency and mild neutropenia in one patient each. 2 patients had pre-existing autoimmune conditions (rheumatoid arthritis and chronic dermatitis), both had transient flares though immunotherapy was continued. Of note, only 3 patients received PDL-1 inhibitors and 1 developed grade II polymyalgia rheumatica and hypothyroidism.
Using multivariate logistic regression, we found no significant association between irAEs and age, body mass index, derived neutrophil to lymphocyte ratio, chronic kidney disease or environmental/medical allergies.
CONCLUSIONS: ICPIs were generally well tolerated in our population, though prompt recognition of rare and severe irAEs is essential. Larger studies are needed to investigate the predictive risk factors for irAEs.
A Multi-Center Retrospective Study Evaluating Palliative Antineoplastic Therapy Administered and Medication De-escalation in Veteran Cancer Patients Toward the End-of-life
BACKGROUND: Metastatic cancer patients near endof- life often continue to receive aggressive cancer treatments and are prescribed many chronic futile medications. The American Society of Clinical Oncology recommends avoiding use of chemotherapy towards end of life in solid tumor patients with poor performance due to potential risk of adverse events.
OBJECTIVES: The objective of this multi-site study was to evaluate the incidence of palliative antineoplastic therapy administration for patients with metastatic cancer as well as the number of patients who received non-essential medications at thirty and fourteen days prior to death.
METHODS: This was a retrospective, multicenter study conducted at 6 Veteran Affairs Medical Centers: Southern Arizona, Lexington, Robley Rex, John D Dingell, San Diego, and Richard L Roudebush. The electronic medical record system identified patients deceased between July 1, 2016 to June 30, 2018 with metastatic lung, colorectal, prostate, pancreatic cancer, or melanoma. Data were analyzed using descriptive analysis.
RESULTS: A total of 651 patients were included in the multicenter study, and the average age of veterans was 71 years with metastatic lung cancer being the most common malignancy at 55%. Within 30 days and 14 days of death, respectively, 24.6% and 13.2% had an antineoplastic agent. Within the last 30 days of life, 45% of patients received systemic chemotherapy, 38% received oral targeted agent, and 17% received immunotherapy. Within last 30 days of life, 50% received a first line treatment, 26.9% received a second line treatment, and 23.2% received ≥ third line of treatment. There was a large proportion of patients hospitalized (n=208) and/ or had ED visits (n=204) due to antineoplastic treatment and/or complications from malignancy. Within the last 30 days of death, 76.3% had ≥ 1 active chronic medication. Palliative care providers were the top recommenders for medication de-escalation.
CONCLUSION: The results of this multi-site retrospective study provides insight into the management of endof- life care for metastatic cancer patients across the VA health care system. Overall the results of this study demonstrate an opportunity for promoting detailed discussions with patients regarding palliative care earlier after diagnosis of metastatic cancer.
BACKGROUND: Metastatic cancer patients near endof- life often continue to receive aggressive cancer treatments and are prescribed many chronic futile medications. The American Society of Clinical Oncology recommends avoiding use of chemotherapy towards end of life in solid tumor patients with poor performance due to potential risk of adverse events.
OBJECTIVES: The objective of this multi-site study was to evaluate the incidence of palliative antineoplastic therapy administration for patients with metastatic cancer as well as the number of patients who received non-essential medications at thirty and fourteen days prior to death.
METHODS: This was a retrospective, multicenter study conducted at 6 Veteran Affairs Medical Centers: Southern Arizona, Lexington, Robley Rex, John D Dingell, San Diego, and Richard L Roudebush. The electronic medical record system identified patients deceased between July 1, 2016 to June 30, 2018 with metastatic lung, colorectal, prostate, pancreatic cancer, or melanoma. Data were analyzed using descriptive analysis.
RESULTS: A total of 651 patients were included in the multicenter study, and the average age of veterans was 71 years with metastatic lung cancer being the most common malignancy at 55%. Within 30 days and 14 days of death, respectively, 24.6% and 13.2% had an antineoplastic agent. Within the last 30 days of life, 45% of patients received systemic chemotherapy, 38% received oral targeted agent, and 17% received immunotherapy. Within last 30 days of life, 50% received a first line treatment, 26.9% received a second line treatment, and 23.2% received ≥ third line of treatment. There was a large proportion of patients hospitalized (n=208) and/ or had ED visits (n=204) due to antineoplastic treatment and/or complications from malignancy. Within the last 30 days of death, 76.3% had ≥ 1 active chronic medication. Palliative care providers were the top recommenders for medication de-escalation.
CONCLUSION: The results of this multi-site retrospective study provides insight into the management of endof- life care for metastatic cancer patients across the VA health care system. Overall the results of this study demonstrate an opportunity for promoting detailed discussions with patients regarding palliative care earlier after diagnosis of metastatic cancer.
BACKGROUND: Metastatic cancer patients near endof- life often continue to receive aggressive cancer treatments and are prescribed many chronic futile medications. The American Society of Clinical Oncology recommends avoiding use of chemotherapy towards end of life in solid tumor patients with poor performance due to potential risk of adverse events.
OBJECTIVES: The objective of this multi-site study was to evaluate the incidence of palliative antineoplastic therapy administration for patients with metastatic cancer as well as the number of patients who received non-essential medications at thirty and fourteen days prior to death.
METHODS: This was a retrospective, multicenter study conducted at 6 Veteran Affairs Medical Centers: Southern Arizona, Lexington, Robley Rex, John D Dingell, San Diego, and Richard L Roudebush. The electronic medical record system identified patients deceased between July 1, 2016 to June 30, 2018 with metastatic lung, colorectal, prostate, pancreatic cancer, or melanoma. Data were analyzed using descriptive analysis.
RESULTS: A total of 651 patients were included in the multicenter study, and the average age of veterans was 71 years with metastatic lung cancer being the most common malignancy at 55%. Within 30 days and 14 days of death, respectively, 24.6% and 13.2% had an antineoplastic agent. Within the last 30 days of life, 45% of patients received systemic chemotherapy, 38% received oral targeted agent, and 17% received immunotherapy. Within last 30 days of life, 50% received a first line treatment, 26.9% received a second line treatment, and 23.2% received ≥ third line of treatment. There was a large proportion of patients hospitalized (n=208) and/ or had ED visits (n=204) due to antineoplastic treatment and/or complications from malignancy. Within the last 30 days of death, 76.3% had ≥ 1 active chronic medication. Palliative care providers were the top recommenders for medication de-escalation.
CONCLUSION: The results of this multi-site retrospective study provides insight into the management of endof- life care for metastatic cancer patients across the VA health care system. Overall the results of this study demonstrate an opportunity for promoting detailed discussions with patients regarding palliative care earlier after diagnosis of metastatic cancer.
Effects of Computer-Based Documentation Procedures on Health Care Workload Assessment and Resource Allocation: An Example From VA Sleep Medicine Programs
Health care systems are faced with the challenge of meeting increasing patient care demands with finite resources.1 Advocating for additional capital—specifically, human resources—requires compelling data that accurately capture workload credit. When workload is not captured accurately, clinicians may be tasked with providing care to a high volume of patients without appropriate resource allocation. This understaffing can delay care delivery and increase the risk of diagnostic and treatment errors.2 Furthermore, workers in understaffed medical facilities are more likely to experience burnout, which leads to high workforce turnover.
Computer based documentation (CBD) is used often in medical practices to track patient care and clinical workload. However, improperly designed and implemented CBD systems can contribute to cumbersome documentation tasks and inaccurate or incomplete data capture.3 Conversely, CBD can be a useful tool to capture workload credit and can subsequently facilitate justification for medical staff allocation to meet patient care demands. This article uses our experience with US Department of Veterans Affairs (VA) national sleep medicine programs to illustrate the impact of CBD procedures on health care workload assessment and allocation. Specifically, we examine how appropriate workload capture facilitates growth and improves the efficiency of health care programs.
The VA is the largest integrated health care system in the US, serving 9 million veterans at 1,255 facilities, including 170 VA Medical Centers (VAMCs).4 As veterans’ demands for VA medical services have outpaced available resources, there have been several media reports of lapses in timely care delivery.5-7 These lapses have been due, in part, to insufficient workforce resource allocation within the Veterans Health Administration (VHA) facilities. A 2012 audit of physician staffing levels conducted by the VA Inspector General concluded that the VA did not have an effective staffing methodology to ensure appropriate staffing levels for specialty care services.8 The lack of staffing plans and productivity standards limits the ability of medical facility officials to make informed business decisions regarding the appropriate number of specialty physicians required to meet patient care needs.8 In 2017, the Government Accountability Office (GAO) issued a report to Congress that stated the “VA’s productivity metrics and efficiency models do not provide complete and accurate information, they may misrepresent the true level of productivity and efficiency across VAMCs and limit the VA’s ability to determine the extent to which its resources are being used effectively.”9 To understand how and why many VA medical facilities remain understaffed, and therefore struggle to provide health care to veterans in a timely fashion, a description of VA CBD procedures is provided.
Background
VA Directive 1082 on Patient Care Data requires the capture of all outpatient and inpatient billable encounter data.10 Accurate capture of workload informs budget allocation models and is necessary for health care provider (HCP) productivity metrics. These data points help identify staff shortages relative to the generated workload. The Veterans Equitable Resource Allocation (VERA) model is used to allocate general purpose funds to the Veterans Integrated Service Networks (VISNs) regional network of VHA facilities. The underlying data components of the VERA model rely on comprehensive data systems that track and analyze the many management information systems used in VHA. Historically, at least 90% of the funds allocated by the VERA model have been attributed directly to patient care. All workload that is appropriately documented is accounted for in the VERA patient classification process, which is the official data source for funding patient care in VHA.
VA medical facilities use Stop Codes (formerly known as Decision Support System Identifiers) to identify workload for all outpatient encounters and inpatient professional services. Each code is composed of a 6-character descriptor that includes a primary Stop Code and a credit (secondary) Stop Code. Primary Stop Codes—the first 3 numbers in the sequence—designate the main clinical group responsible for patient care, such as sleep medicine or neurology. Secondary Stop Codes—the last 3 numbers in the sequence—further define the primary workgroup, such as the type of services provided (eg, telehealth) or the type of HCP (eg, nurse practitioner). These codes help ensure that workload and generated revenue are allocated or credited to the proper specialty care service.11 An example of how changes or inaccuracies in Stop Code reporting can affect VHA clinical workload assessment and resource allocation is provided by the VHA sleep medicine program.
The prevalence of sleep disorders—particularly apnea and insomnia—among US military service members and veterans has increased dramatically over the past 2 decades and continues to rise.12-14 Consequently, demand for sleep care services at VHA facilities also has increased substantially (Figure 1). Unfortunately, this demand has outpaced the VHA’s staffing models, sometimes resulting in long wait times for appointments.15 In fact, sleep medicine remains one of the most backlogged services in the VHA, despite significant improvements in program efficiency achieved by incorporating telehealth modalities.16 Untreated sleep disorders are associated with increased risk of depression, anxiety, impaired neurocognitive functions, cardiovascular disease, motor vehicle accidents, and premature death.17-23
A major contributor to understaffing of VHA sleep medicine programs is the CBD system’s historical inability to accurately track sleep resources and demand for sleep care services. For many years, Stop Codes attributed sleep workload credit primarily to pulmonary medicine, neurology, and internal medicine workgroups. Within these workgroups, few individuals contributed to sleep care, but the entire workgroup received credit for these services, masking the workload of sleep care providers. Additional barriers to accurate sleep medicine workload capture within the VHA included (1) inability to centrally identify personnel, including physicians, as providers of sleep care; (2) limited and variable understanding among VA sleep physicians of the importance of proper encounter form completion (the mechanism by which the cost of a service is calculated); and (3) a lack of awareness that encounter closure is directly linked to productivity measures such as relative value units (RVUs) that support sleep medicine programs and the salaries of those who provide care.
Methods
The critical role of accurate CBD in health care administration is illustrated by the proper use of Stop Codes as a foundational step in tracking services provided to justify adequate resource allocation within VA. A complete redesign of tracking sleep service documentation was initiated in 2014 and resulted in national changes to sleep medicine Stop Codes. The Stop Code initiative was the first step of several to improve CBD for VA sleep services.
Primary Stop Code 349 designates sleep medicine encounters in VA facilities (Table). However, before changes were implemented in fiscal year (FY) 2015, Stop Codes for VHA sleep care did not differentiate between specific services provided, such as laboratory-based sleep testing, at-home sleep testing, education/training sessions, follow-up appointments, equipment consults, telephone or video consults, or administrative tasks. In early FY 2015, several changes were made to Stop Codes used for VHA sleep medicine services nationwide to capture the breadth of services that were being provided; services that had previously been performed but were not documented. A new standardized coding methodology was established for continuous positive airway pressure (CPAP) clinics (349/116 or 349/117); telephone consults for sleep care (324/349); and store and forward sleep telehealth encounters (349/694, 349/695, or 349/696).
In the VA, store-and-forward telehealth refers to asynchronous telemedicine involving the acquisition and storing of clinical information (eg, data, image, sound, or video) that another site or clinician reviews later for evaluation and interpretation. In sleep medicine, data uploaded from home sleep apnea test units or CPAP devices are examples of this asynchronous telehealth model. The goal of these changes in VA Stop Codes was to accurately assess the volume of sleep care delivered and the demand for sleep care (consult volumes); enable planning for resource allocation and utilization appropriately; provide veterans with consistent access to sleep services across the country; and facilitate reductions in wait times for sleep care appointments. Results of these changes were immediate and dramatic in terms of data capture and reporting.
Results
Figure 1 illustrates an increase in patient encounters in VA sleep clinics by 24,197 (19.6%) in the first quarter of Stop Code change implementation (FY 2015, quarter 2) compared with those of the previous quarter. VHA sleep clinic patient encounters increased in subsequent quarters of FY 2015 by 29,910 (20.2%) and 11,206 (6.3%) respectively. By the end of FY 2015, reported sleep clinic encounters increased by 190,803 compared with the those at the end of FY 2014, an increase of 42.7%.
Figures 2, 3, and 4 show the additional effects of sleep Stop Code changes that were implemented in FY 2015 for CPAP clinics, telephone encounters, and store-and-forward telehealth encounters, respectively. The large increases in reported sleep patient encounters between FY 2014 and FY 2016 reflect changes in CBD and are not entirely due to actual changes in clinical workloads. These results indicate that workloads in many VHA sleep medicine clinics were grossly underreported or misallocated to other specialty services prior to the changes implemented in FY 2015. This discrepancy in care delivery vs workload capture is a contributing factor to the understaffing that continues to challenge VHA sleep programs. However, the improved accuracy of workload reporting that resulted from Stop Code modifications has resulted in only a small proportional increase in VHA clinical resources allocated to provide adequate services and care for veterans with sleep disorders.
In response to the substantial and increasing demand for sleep services by veterans, the VA Office of Rural Health (ORH) funded an enterprise-wide initiative (EWI) to develop and implement a national TeleSleep Program.16 The goal of this program is to improve the health and well-being of rural veterans by increasing their access to sleep care and services.
Discussion
Inaccuracies in CBD procedures can adversely affect health care workload assessment and allocation, contributing to ongoing challenges faced by sleep medicine clinics and other VHA programs that have limited staff yet strive to provide timely and high-quality care to veterans. “Not only does inaccurate coding contribute to miscalculations in staffing and resource allocation, it can also contribute to inaccuracies in overall measures of VA healthcare efficiency,” the GAO reported to Congress.9 The GAO went on to recommend that the VA should ensure the accuracy of underlying staffing and workload data. VHA sleep medicine programs have made efforts to educate HCPs and administrators on the importance of accurate CBD as a tool for accurate data capture that is necessary to facilitate improvements in health care availability and delivery.
In 2018, the VA Sleep Program Office released an updated set of Stop Code changes, including expansion of telehealth codes and improved designation of laboratory and home sleep testing services. These changes are anticipated to result in accurate documentation of VA sleep clinic workload and services, especially as the VA TeleSleep EWI to reach rural veterans expands.16 In light of the improved accuracy of reporting of delivered sleep services due to changes in Stop Codes over the past 4 years, VHA sleep medicine providers continue to advocate for allocation of resources commensurate with their clinical workload. An appropriate administrative response to the significant clinical workload performed by disproportionately few providers should include the authorization of increased resources and personnel for sleep medicine as well as providing the tools needed to further streamline workflow efficiency (eg, artificial intelligence, machine learning, and population health management).
Conclusions
Despite the barriers faced by many large integrated health care systems, VHA sleep medicine leadership continues to implement changes in CBD protocols that improve the accuracy of clinical workload tracking and reporting. Ultimately, these changes will support proposals for increased resources necessary to improve the quality and availability of sleep care for veterans. This example from VA illustrates the importance of accurate workload capture and its role in informing administrators of health care systems as they strive to meet the needs of patients. Although some VA sleep medicine programs continue to face challenges imposed by systemwide limitations, the ORH TeleSleep Program is a major initiative that improves veterans’ access to care by disseminating and implementing effective telehealth technologies and strategies.16
Acknowledgments
This work was supported by a VA Office of Rural Health Enterprise-Wide Initiative.
1. World Health Organization. Workload indicators of staffing need (WISN). https://www.who.int/hrh/resources/WISN_Eng_UsersManual.pdf?ua=1. Published December 2015. Accessed June 24, 2020.
2. American Association for Respiratory Care. Position statement: best practices in respiratory care productivity and staffing. https://www.aarc.org/wp-content/uploads/2017/03/statement-of-best-practices_productivity-and-staffing.pdf. Revised July 2015. Accessed June 24, 2020.
3. Wu DTY, Smart N, Ciemins EL, Lanham HJ, Lindberg C, Zheng K. Using EHR audit trail logs to analyze clinical workflow: a case study from community-based ambulatory clinics. AMIA Annu Symp Proc. 2018;2017:1820-1827. Published 2018 Apr 16.
4. US Department of Veterans Affairs, Veterans Health Administration. https://www.va.gov/health.
5. Cohen T. VA crisis: solutions exist, but haven’t happened, panel hears. https://www.cnn.com/2014/06/12/politics/va-reforms/index.html. Published June 12, 2014. Accessed June 24, 2020.
6. Richardson B. IG probes uncover more problems at VA hospitals. https://thehill.com/policy/defense/258652-ig-probes-uncover-more-problems-at-va-hospitals. Published October 30, 2015. Accessed June 24, 2020.
7. Slack D. Inaccurate VA wait times prelude thousands of vets from getting outside care, probe finds. USA Today. March 3, 2017. https://www.usatoday.com/story/news/politics/2017/03/03/veterans-affairs-inspector-general-widespread-inaccuracies-wait-times/98693856. Accessed June 24, 2020.
8. US Department of Veterans Affairs, Office of the Inspector General. Veterans Health Administration: audit of physician staffing levels for specialty care services. https://www.va.gov/oig/pubs/VAOIG-11-01827-36.pdf. Published December 27, 2012. Accessed June 24, 2020.
9. Government Accountability Office. VA health care: improvements needed in data and monitoring of clinical productivity and efficiency. https://www.gao.gov/assets/690/684869.pdf. Published May 2017. Accessed June 24, 2020.
10. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1082. Patient care data capture. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3091. Published March 24, 2015. Accessed June 24, 2020.
11. US Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1006.02. VHA site classifications and definitions. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2970. Published December 30, 2013. Accessed June 24, 2020.
12. Alexander M, Ray MA, Hébert JR, et al. The National Veteran Sleep Disorder Study: Descriptive Epidemiology and Secular Trends, 2000-2010. Sleep. 2016;39(7):1399-1410. Published 2016 Jul 1. doi:10.5665/sleep.5972.
13. A Caldwell J, Knapik JJ, Lieberman HR. Trends and factors associated with insomnia and sleep apnea in all United States military service members from 2005 to 2014. J Sleep Res. 2017;26(5):665-670. doi:10.1111/jsr.12543
14. Klingaman EA, Brownlow JA, Boland EM, Mosti C, Gehrman PR. Prevalence, predictors and correlates of insomnia in US army soldiers. J Sleep Res. 2018;27(3):e12612. doi:10.1111/jsr.12612
15. Sharafkhaneh A, Richardson P, Hirshkowitz M. Sleep apnea in a high risk population: a study of Veterans Health Administration beneficiaries. Sleep Med. 2004;5(4):345-350. doi:10.1016/j.sleep.2004.01.019.
16. Sarmiento KF, Folmer RL, Stepnowsky CJ, et al. National Expansion of Sleep Telemedicine for Veterans: The TeleSleep Program. J Clin Sleep Med. 2019;15(9):1355-1364. doi:10.5664/jcsm.7934
17. Van Dongen HP, Maislin G, Mullington JM, Dinges DF. The cumulative cost of additional wakefulness: dose-response effects on neurobehavioral functions and sleep physiology from chronic sleep restriction and total sleep deprivation [published correction appears in Sleep. 2004 Jun 15;27(4):600]. Sleep. 2003;26(2):117-126. doi:10.1093/sleep/26.2.117
18. Johnson EO, Roth T, Breslau N. The association of insomnia with anxiety disorders and depression: exploration of the direction of risk. J Psychiatr Res. 2006;40(8):700-708. doi:10.1016/j.jpsychires.2006.07.008
19. Léger D, Bayon V, Ohayon MM, et al. Insomnia and accidents: cross-sectional study (EQUINOX) on sleep-related home, work and car accidents in 5293 subjects with insomnia from 10 countries. J Sleep Res. 2014;23(2):143-152. doi:10.1111/jsr.12104
20. Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015;7(8):1311-1322. doi:10.3978/j.issn.2072-1439.2015.06.11
21. Javaheri S, Redline S. Insomnia and Risk of Cardiovascular Disease. Chest. 2017;152(2):435-444. doi:10.1016/j.chest.2017.01.026
22. Linz D, McEvoy RD, Cowie MR, et al. Associations of obstructivesSleepaApnea with atrial fibrillation and continuous positive airway pressure treatment: a review. JAMA Cardiol. 2018;3(6):532-540. doi:10.1001/jamacardio.2018.0095
23. Ogilvie RP, Lakshminarayan K, Iber C, Patel SR, Lutsey PL. Joint effects of OSA and self-reported sleepiness on incident CHD and stroke. Sleep Med. 2018;44:32-37. doi:10.1016/j.sleep.2018.01.004
Health care systems are faced with the challenge of meeting increasing patient care demands with finite resources.1 Advocating for additional capital—specifically, human resources—requires compelling data that accurately capture workload credit. When workload is not captured accurately, clinicians may be tasked with providing care to a high volume of patients without appropriate resource allocation. This understaffing can delay care delivery and increase the risk of diagnostic and treatment errors.2 Furthermore, workers in understaffed medical facilities are more likely to experience burnout, which leads to high workforce turnover.
Computer based documentation (CBD) is used often in medical practices to track patient care and clinical workload. However, improperly designed and implemented CBD systems can contribute to cumbersome documentation tasks and inaccurate or incomplete data capture.3 Conversely, CBD can be a useful tool to capture workload credit and can subsequently facilitate justification for medical staff allocation to meet patient care demands. This article uses our experience with US Department of Veterans Affairs (VA) national sleep medicine programs to illustrate the impact of CBD procedures on health care workload assessment and allocation. Specifically, we examine how appropriate workload capture facilitates growth and improves the efficiency of health care programs.
The VA is the largest integrated health care system in the US, serving 9 million veterans at 1,255 facilities, including 170 VA Medical Centers (VAMCs).4 As veterans’ demands for VA medical services have outpaced available resources, there have been several media reports of lapses in timely care delivery.5-7 These lapses have been due, in part, to insufficient workforce resource allocation within the Veterans Health Administration (VHA) facilities. A 2012 audit of physician staffing levels conducted by the VA Inspector General concluded that the VA did not have an effective staffing methodology to ensure appropriate staffing levels for specialty care services.8 The lack of staffing plans and productivity standards limits the ability of medical facility officials to make informed business decisions regarding the appropriate number of specialty physicians required to meet patient care needs.8 In 2017, the Government Accountability Office (GAO) issued a report to Congress that stated the “VA’s productivity metrics and efficiency models do not provide complete and accurate information, they may misrepresent the true level of productivity and efficiency across VAMCs and limit the VA’s ability to determine the extent to which its resources are being used effectively.”9 To understand how and why many VA medical facilities remain understaffed, and therefore struggle to provide health care to veterans in a timely fashion, a description of VA CBD procedures is provided.
Background
VA Directive 1082 on Patient Care Data requires the capture of all outpatient and inpatient billable encounter data.10 Accurate capture of workload informs budget allocation models and is necessary for health care provider (HCP) productivity metrics. These data points help identify staff shortages relative to the generated workload. The Veterans Equitable Resource Allocation (VERA) model is used to allocate general purpose funds to the Veterans Integrated Service Networks (VISNs) regional network of VHA facilities. The underlying data components of the VERA model rely on comprehensive data systems that track and analyze the many management information systems used in VHA. Historically, at least 90% of the funds allocated by the VERA model have been attributed directly to patient care. All workload that is appropriately documented is accounted for in the VERA patient classification process, which is the official data source for funding patient care in VHA.
VA medical facilities use Stop Codes (formerly known as Decision Support System Identifiers) to identify workload for all outpatient encounters and inpatient professional services. Each code is composed of a 6-character descriptor that includes a primary Stop Code and a credit (secondary) Stop Code. Primary Stop Codes—the first 3 numbers in the sequence—designate the main clinical group responsible for patient care, such as sleep medicine or neurology. Secondary Stop Codes—the last 3 numbers in the sequence—further define the primary workgroup, such as the type of services provided (eg, telehealth) or the type of HCP (eg, nurse practitioner). These codes help ensure that workload and generated revenue are allocated or credited to the proper specialty care service.11 An example of how changes or inaccuracies in Stop Code reporting can affect VHA clinical workload assessment and resource allocation is provided by the VHA sleep medicine program.
The prevalence of sleep disorders—particularly apnea and insomnia—among US military service members and veterans has increased dramatically over the past 2 decades and continues to rise.12-14 Consequently, demand for sleep care services at VHA facilities also has increased substantially (Figure 1). Unfortunately, this demand has outpaced the VHA’s staffing models, sometimes resulting in long wait times for appointments.15 In fact, sleep medicine remains one of the most backlogged services in the VHA, despite significant improvements in program efficiency achieved by incorporating telehealth modalities.16 Untreated sleep disorders are associated with increased risk of depression, anxiety, impaired neurocognitive functions, cardiovascular disease, motor vehicle accidents, and premature death.17-23
A major contributor to understaffing of VHA sleep medicine programs is the CBD system’s historical inability to accurately track sleep resources and demand for sleep care services. For many years, Stop Codes attributed sleep workload credit primarily to pulmonary medicine, neurology, and internal medicine workgroups. Within these workgroups, few individuals contributed to sleep care, but the entire workgroup received credit for these services, masking the workload of sleep care providers. Additional barriers to accurate sleep medicine workload capture within the VHA included (1) inability to centrally identify personnel, including physicians, as providers of sleep care; (2) limited and variable understanding among VA sleep physicians of the importance of proper encounter form completion (the mechanism by which the cost of a service is calculated); and (3) a lack of awareness that encounter closure is directly linked to productivity measures such as relative value units (RVUs) that support sleep medicine programs and the salaries of those who provide care.
Methods
The critical role of accurate CBD in health care administration is illustrated by the proper use of Stop Codes as a foundational step in tracking services provided to justify adequate resource allocation within VA. A complete redesign of tracking sleep service documentation was initiated in 2014 and resulted in national changes to sleep medicine Stop Codes. The Stop Code initiative was the first step of several to improve CBD for VA sleep services.
Primary Stop Code 349 designates sleep medicine encounters in VA facilities (Table). However, before changes were implemented in fiscal year (FY) 2015, Stop Codes for VHA sleep care did not differentiate between specific services provided, such as laboratory-based sleep testing, at-home sleep testing, education/training sessions, follow-up appointments, equipment consults, telephone or video consults, or administrative tasks. In early FY 2015, several changes were made to Stop Codes used for VHA sleep medicine services nationwide to capture the breadth of services that were being provided; services that had previously been performed but were not documented. A new standardized coding methodology was established for continuous positive airway pressure (CPAP) clinics (349/116 or 349/117); telephone consults for sleep care (324/349); and store and forward sleep telehealth encounters (349/694, 349/695, or 349/696).
In the VA, store-and-forward telehealth refers to asynchronous telemedicine involving the acquisition and storing of clinical information (eg, data, image, sound, or video) that another site or clinician reviews later for evaluation and interpretation. In sleep medicine, data uploaded from home sleep apnea test units or CPAP devices are examples of this asynchronous telehealth model. The goal of these changes in VA Stop Codes was to accurately assess the volume of sleep care delivered and the demand for sleep care (consult volumes); enable planning for resource allocation and utilization appropriately; provide veterans with consistent access to sleep services across the country; and facilitate reductions in wait times for sleep care appointments. Results of these changes were immediate and dramatic in terms of data capture and reporting.
Results
Figure 1 illustrates an increase in patient encounters in VA sleep clinics by 24,197 (19.6%) in the first quarter of Stop Code change implementation (FY 2015, quarter 2) compared with those of the previous quarter. VHA sleep clinic patient encounters increased in subsequent quarters of FY 2015 by 29,910 (20.2%) and 11,206 (6.3%) respectively. By the end of FY 2015, reported sleep clinic encounters increased by 190,803 compared with the those at the end of FY 2014, an increase of 42.7%.
Figures 2, 3, and 4 show the additional effects of sleep Stop Code changes that were implemented in FY 2015 for CPAP clinics, telephone encounters, and store-and-forward telehealth encounters, respectively. The large increases in reported sleep patient encounters between FY 2014 and FY 2016 reflect changes in CBD and are not entirely due to actual changes in clinical workloads. These results indicate that workloads in many VHA sleep medicine clinics were grossly underreported or misallocated to other specialty services prior to the changes implemented in FY 2015. This discrepancy in care delivery vs workload capture is a contributing factor to the understaffing that continues to challenge VHA sleep programs. However, the improved accuracy of workload reporting that resulted from Stop Code modifications has resulted in only a small proportional increase in VHA clinical resources allocated to provide adequate services and care for veterans with sleep disorders.
In response to the substantial and increasing demand for sleep services by veterans, the VA Office of Rural Health (ORH) funded an enterprise-wide initiative (EWI) to develop and implement a national TeleSleep Program.16 The goal of this program is to improve the health and well-being of rural veterans by increasing their access to sleep care and services.
Discussion
Inaccuracies in CBD procedures can adversely affect health care workload assessment and allocation, contributing to ongoing challenges faced by sleep medicine clinics and other VHA programs that have limited staff yet strive to provide timely and high-quality care to veterans. “Not only does inaccurate coding contribute to miscalculations in staffing and resource allocation, it can also contribute to inaccuracies in overall measures of VA healthcare efficiency,” the GAO reported to Congress.9 The GAO went on to recommend that the VA should ensure the accuracy of underlying staffing and workload data. VHA sleep medicine programs have made efforts to educate HCPs and administrators on the importance of accurate CBD as a tool for accurate data capture that is necessary to facilitate improvements in health care availability and delivery.
In 2018, the VA Sleep Program Office released an updated set of Stop Code changes, including expansion of telehealth codes and improved designation of laboratory and home sleep testing services. These changes are anticipated to result in accurate documentation of VA sleep clinic workload and services, especially as the VA TeleSleep EWI to reach rural veterans expands.16 In light of the improved accuracy of reporting of delivered sleep services due to changes in Stop Codes over the past 4 years, VHA sleep medicine providers continue to advocate for allocation of resources commensurate with their clinical workload. An appropriate administrative response to the significant clinical workload performed by disproportionately few providers should include the authorization of increased resources and personnel for sleep medicine as well as providing the tools needed to further streamline workflow efficiency (eg, artificial intelligence, machine learning, and population health management).
Conclusions
Despite the barriers faced by many large integrated health care systems, VHA sleep medicine leadership continues to implement changes in CBD protocols that improve the accuracy of clinical workload tracking and reporting. Ultimately, these changes will support proposals for increased resources necessary to improve the quality and availability of sleep care for veterans. This example from VA illustrates the importance of accurate workload capture and its role in informing administrators of health care systems as they strive to meet the needs of patients. Although some VA sleep medicine programs continue to face challenges imposed by systemwide limitations, the ORH TeleSleep Program is a major initiative that improves veterans’ access to care by disseminating and implementing effective telehealth technologies and strategies.16
Acknowledgments
This work was supported by a VA Office of Rural Health Enterprise-Wide Initiative.
Health care systems are faced with the challenge of meeting increasing patient care demands with finite resources.1 Advocating for additional capital—specifically, human resources—requires compelling data that accurately capture workload credit. When workload is not captured accurately, clinicians may be tasked with providing care to a high volume of patients without appropriate resource allocation. This understaffing can delay care delivery and increase the risk of diagnostic and treatment errors.2 Furthermore, workers in understaffed medical facilities are more likely to experience burnout, which leads to high workforce turnover.
Computer based documentation (CBD) is used often in medical practices to track patient care and clinical workload. However, improperly designed and implemented CBD systems can contribute to cumbersome documentation tasks and inaccurate or incomplete data capture.3 Conversely, CBD can be a useful tool to capture workload credit and can subsequently facilitate justification for medical staff allocation to meet patient care demands. This article uses our experience with US Department of Veterans Affairs (VA) national sleep medicine programs to illustrate the impact of CBD procedures on health care workload assessment and allocation. Specifically, we examine how appropriate workload capture facilitates growth and improves the efficiency of health care programs.
The VA is the largest integrated health care system in the US, serving 9 million veterans at 1,255 facilities, including 170 VA Medical Centers (VAMCs).4 As veterans’ demands for VA medical services have outpaced available resources, there have been several media reports of lapses in timely care delivery.5-7 These lapses have been due, in part, to insufficient workforce resource allocation within the Veterans Health Administration (VHA) facilities. A 2012 audit of physician staffing levels conducted by the VA Inspector General concluded that the VA did not have an effective staffing methodology to ensure appropriate staffing levels for specialty care services.8 The lack of staffing plans and productivity standards limits the ability of medical facility officials to make informed business decisions regarding the appropriate number of specialty physicians required to meet patient care needs.8 In 2017, the Government Accountability Office (GAO) issued a report to Congress that stated the “VA’s productivity metrics and efficiency models do not provide complete and accurate information, they may misrepresent the true level of productivity and efficiency across VAMCs and limit the VA’s ability to determine the extent to which its resources are being used effectively.”9 To understand how and why many VA medical facilities remain understaffed, and therefore struggle to provide health care to veterans in a timely fashion, a description of VA CBD procedures is provided.
Background
VA Directive 1082 on Patient Care Data requires the capture of all outpatient and inpatient billable encounter data.10 Accurate capture of workload informs budget allocation models and is necessary for health care provider (HCP) productivity metrics. These data points help identify staff shortages relative to the generated workload. The Veterans Equitable Resource Allocation (VERA) model is used to allocate general purpose funds to the Veterans Integrated Service Networks (VISNs) regional network of VHA facilities. The underlying data components of the VERA model rely on comprehensive data systems that track and analyze the many management information systems used in VHA. Historically, at least 90% of the funds allocated by the VERA model have been attributed directly to patient care. All workload that is appropriately documented is accounted for in the VERA patient classification process, which is the official data source for funding patient care in VHA.
VA medical facilities use Stop Codes (formerly known as Decision Support System Identifiers) to identify workload for all outpatient encounters and inpatient professional services. Each code is composed of a 6-character descriptor that includes a primary Stop Code and a credit (secondary) Stop Code. Primary Stop Codes—the first 3 numbers in the sequence—designate the main clinical group responsible for patient care, such as sleep medicine or neurology. Secondary Stop Codes—the last 3 numbers in the sequence—further define the primary workgroup, such as the type of services provided (eg, telehealth) or the type of HCP (eg, nurse practitioner). These codes help ensure that workload and generated revenue are allocated or credited to the proper specialty care service.11 An example of how changes or inaccuracies in Stop Code reporting can affect VHA clinical workload assessment and resource allocation is provided by the VHA sleep medicine program.
The prevalence of sleep disorders—particularly apnea and insomnia—among US military service members and veterans has increased dramatically over the past 2 decades and continues to rise.12-14 Consequently, demand for sleep care services at VHA facilities also has increased substantially (Figure 1). Unfortunately, this demand has outpaced the VHA’s staffing models, sometimes resulting in long wait times for appointments.15 In fact, sleep medicine remains one of the most backlogged services in the VHA, despite significant improvements in program efficiency achieved by incorporating telehealth modalities.16 Untreated sleep disorders are associated with increased risk of depression, anxiety, impaired neurocognitive functions, cardiovascular disease, motor vehicle accidents, and premature death.17-23
A major contributor to understaffing of VHA sleep medicine programs is the CBD system’s historical inability to accurately track sleep resources and demand for sleep care services. For many years, Stop Codes attributed sleep workload credit primarily to pulmonary medicine, neurology, and internal medicine workgroups. Within these workgroups, few individuals contributed to sleep care, but the entire workgroup received credit for these services, masking the workload of sleep care providers. Additional barriers to accurate sleep medicine workload capture within the VHA included (1) inability to centrally identify personnel, including physicians, as providers of sleep care; (2) limited and variable understanding among VA sleep physicians of the importance of proper encounter form completion (the mechanism by which the cost of a service is calculated); and (3) a lack of awareness that encounter closure is directly linked to productivity measures such as relative value units (RVUs) that support sleep medicine programs and the salaries of those who provide care.
Methods
The critical role of accurate CBD in health care administration is illustrated by the proper use of Stop Codes as a foundational step in tracking services provided to justify adequate resource allocation within VA. A complete redesign of tracking sleep service documentation was initiated in 2014 and resulted in national changes to sleep medicine Stop Codes. The Stop Code initiative was the first step of several to improve CBD for VA sleep services.
Primary Stop Code 349 designates sleep medicine encounters in VA facilities (Table). However, before changes were implemented in fiscal year (FY) 2015, Stop Codes for VHA sleep care did not differentiate between specific services provided, such as laboratory-based sleep testing, at-home sleep testing, education/training sessions, follow-up appointments, equipment consults, telephone or video consults, or administrative tasks. In early FY 2015, several changes were made to Stop Codes used for VHA sleep medicine services nationwide to capture the breadth of services that were being provided; services that had previously been performed but were not documented. A new standardized coding methodology was established for continuous positive airway pressure (CPAP) clinics (349/116 or 349/117); telephone consults for sleep care (324/349); and store and forward sleep telehealth encounters (349/694, 349/695, or 349/696).
In the VA, store-and-forward telehealth refers to asynchronous telemedicine involving the acquisition and storing of clinical information (eg, data, image, sound, or video) that another site or clinician reviews later for evaluation and interpretation. In sleep medicine, data uploaded from home sleep apnea test units or CPAP devices are examples of this asynchronous telehealth model. The goal of these changes in VA Stop Codes was to accurately assess the volume of sleep care delivered and the demand for sleep care (consult volumes); enable planning for resource allocation and utilization appropriately; provide veterans with consistent access to sleep services across the country; and facilitate reductions in wait times for sleep care appointments. Results of these changes were immediate and dramatic in terms of data capture and reporting.
Results
Figure 1 illustrates an increase in patient encounters in VA sleep clinics by 24,197 (19.6%) in the first quarter of Stop Code change implementation (FY 2015, quarter 2) compared with those of the previous quarter. VHA sleep clinic patient encounters increased in subsequent quarters of FY 2015 by 29,910 (20.2%) and 11,206 (6.3%) respectively. By the end of FY 2015, reported sleep clinic encounters increased by 190,803 compared with the those at the end of FY 2014, an increase of 42.7%.
Figures 2, 3, and 4 show the additional effects of sleep Stop Code changes that were implemented in FY 2015 for CPAP clinics, telephone encounters, and store-and-forward telehealth encounters, respectively. The large increases in reported sleep patient encounters between FY 2014 and FY 2016 reflect changes in CBD and are not entirely due to actual changes in clinical workloads. These results indicate that workloads in many VHA sleep medicine clinics were grossly underreported or misallocated to other specialty services prior to the changes implemented in FY 2015. This discrepancy in care delivery vs workload capture is a contributing factor to the understaffing that continues to challenge VHA sleep programs. However, the improved accuracy of workload reporting that resulted from Stop Code modifications has resulted in only a small proportional increase in VHA clinical resources allocated to provide adequate services and care for veterans with sleep disorders.
In response to the substantial and increasing demand for sleep services by veterans, the VA Office of Rural Health (ORH) funded an enterprise-wide initiative (EWI) to develop and implement a national TeleSleep Program.16 The goal of this program is to improve the health and well-being of rural veterans by increasing their access to sleep care and services.
Discussion
Inaccuracies in CBD procedures can adversely affect health care workload assessment and allocation, contributing to ongoing challenges faced by sleep medicine clinics and other VHA programs that have limited staff yet strive to provide timely and high-quality care to veterans. “Not only does inaccurate coding contribute to miscalculations in staffing and resource allocation, it can also contribute to inaccuracies in overall measures of VA healthcare efficiency,” the GAO reported to Congress.9 The GAO went on to recommend that the VA should ensure the accuracy of underlying staffing and workload data. VHA sleep medicine programs have made efforts to educate HCPs and administrators on the importance of accurate CBD as a tool for accurate data capture that is necessary to facilitate improvements in health care availability and delivery.
In 2018, the VA Sleep Program Office released an updated set of Stop Code changes, including expansion of telehealth codes and improved designation of laboratory and home sleep testing services. These changes are anticipated to result in accurate documentation of VA sleep clinic workload and services, especially as the VA TeleSleep EWI to reach rural veterans expands.16 In light of the improved accuracy of reporting of delivered sleep services due to changes in Stop Codes over the past 4 years, VHA sleep medicine providers continue to advocate for allocation of resources commensurate with their clinical workload. An appropriate administrative response to the significant clinical workload performed by disproportionately few providers should include the authorization of increased resources and personnel for sleep medicine as well as providing the tools needed to further streamline workflow efficiency (eg, artificial intelligence, machine learning, and population health management).
Conclusions
Despite the barriers faced by many large integrated health care systems, VHA sleep medicine leadership continues to implement changes in CBD protocols that improve the accuracy of clinical workload tracking and reporting. Ultimately, these changes will support proposals for increased resources necessary to improve the quality and availability of sleep care for veterans. This example from VA illustrates the importance of accurate workload capture and its role in informing administrators of health care systems as they strive to meet the needs of patients. Although some VA sleep medicine programs continue to face challenges imposed by systemwide limitations, the ORH TeleSleep Program is a major initiative that improves veterans’ access to care by disseminating and implementing effective telehealth technologies and strategies.16
Acknowledgments
This work was supported by a VA Office of Rural Health Enterprise-Wide Initiative.
1. World Health Organization. Workload indicators of staffing need (WISN). https://www.who.int/hrh/resources/WISN_Eng_UsersManual.pdf?ua=1. Published December 2015. Accessed June 24, 2020.
2. American Association for Respiratory Care. Position statement: best practices in respiratory care productivity and staffing. https://www.aarc.org/wp-content/uploads/2017/03/statement-of-best-practices_productivity-and-staffing.pdf. Revised July 2015. Accessed June 24, 2020.
3. Wu DTY, Smart N, Ciemins EL, Lanham HJ, Lindberg C, Zheng K. Using EHR audit trail logs to analyze clinical workflow: a case study from community-based ambulatory clinics. AMIA Annu Symp Proc. 2018;2017:1820-1827. Published 2018 Apr 16.
4. US Department of Veterans Affairs, Veterans Health Administration. https://www.va.gov/health.
5. Cohen T. VA crisis: solutions exist, but haven’t happened, panel hears. https://www.cnn.com/2014/06/12/politics/va-reforms/index.html. Published June 12, 2014. Accessed June 24, 2020.
6. Richardson B. IG probes uncover more problems at VA hospitals. https://thehill.com/policy/defense/258652-ig-probes-uncover-more-problems-at-va-hospitals. Published October 30, 2015. Accessed June 24, 2020.
7. Slack D. Inaccurate VA wait times prelude thousands of vets from getting outside care, probe finds. USA Today. March 3, 2017. https://www.usatoday.com/story/news/politics/2017/03/03/veterans-affairs-inspector-general-widespread-inaccuracies-wait-times/98693856. Accessed June 24, 2020.
8. US Department of Veterans Affairs, Office of the Inspector General. Veterans Health Administration: audit of physician staffing levels for specialty care services. https://www.va.gov/oig/pubs/VAOIG-11-01827-36.pdf. Published December 27, 2012. Accessed June 24, 2020.
9. Government Accountability Office. VA health care: improvements needed in data and monitoring of clinical productivity and efficiency. https://www.gao.gov/assets/690/684869.pdf. Published May 2017. Accessed June 24, 2020.
10. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1082. Patient care data capture. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3091. Published March 24, 2015. Accessed June 24, 2020.
11. US Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1006.02. VHA site classifications and definitions. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2970. Published December 30, 2013. Accessed June 24, 2020.
12. Alexander M, Ray MA, Hébert JR, et al. The National Veteran Sleep Disorder Study: Descriptive Epidemiology and Secular Trends, 2000-2010. Sleep. 2016;39(7):1399-1410. Published 2016 Jul 1. doi:10.5665/sleep.5972.
13. A Caldwell J, Knapik JJ, Lieberman HR. Trends and factors associated with insomnia and sleep apnea in all United States military service members from 2005 to 2014. J Sleep Res. 2017;26(5):665-670. doi:10.1111/jsr.12543
14. Klingaman EA, Brownlow JA, Boland EM, Mosti C, Gehrman PR. Prevalence, predictors and correlates of insomnia in US army soldiers. J Sleep Res. 2018;27(3):e12612. doi:10.1111/jsr.12612
15. Sharafkhaneh A, Richardson P, Hirshkowitz M. Sleep apnea in a high risk population: a study of Veterans Health Administration beneficiaries. Sleep Med. 2004;5(4):345-350. doi:10.1016/j.sleep.2004.01.019.
16. Sarmiento KF, Folmer RL, Stepnowsky CJ, et al. National Expansion of Sleep Telemedicine for Veterans: The TeleSleep Program. J Clin Sleep Med. 2019;15(9):1355-1364. doi:10.5664/jcsm.7934
17. Van Dongen HP, Maislin G, Mullington JM, Dinges DF. The cumulative cost of additional wakefulness: dose-response effects on neurobehavioral functions and sleep physiology from chronic sleep restriction and total sleep deprivation [published correction appears in Sleep. 2004 Jun 15;27(4):600]. Sleep. 2003;26(2):117-126. doi:10.1093/sleep/26.2.117
18. Johnson EO, Roth T, Breslau N. The association of insomnia with anxiety disorders and depression: exploration of the direction of risk. J Psychiatr Res. 2006;40(8):700-708. doi:10.1016/j.jpsychires.2006.07.008
19. Léger D, Bayon V, Ohayon MM, et al. Insomnia and accidents: cross-sectional study (EQUINOX) on sleep-related home, work and car accidents in 5293 subjects with insomnia from 10 countries. J Sleep Res. 2014;23(2):143-152. doi:10.1111/jsr.12104
20. Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015;7(8):1311-1322. doi:10.3978/j.issn.2072-1439.2015.06.11
21. Javaheri S, Redline S. Insomnia and Risk of Cardiovascular Disease. Chest. 2017;152(2):435-444. doi:10.1016/j.chest.2017.01.026
22. Linz D, McEvoy RD, Cowie MR, et al. Associations of obstructivesSleepaApnea with atrial fibrillation and continuous positive airway pressure treatment: a review. JAMA Cardiol. 2018;3(6):532-540. doi:10.1001/jamacardio.2018.0095
23. Ogilvie RP, Lakshminarayan K, Iber C, Patel SR, Lutsey PL. Joint effects of OSA and self-reported sleepiness on incident CHD and stroke. Sleep Med. 2018;44:32-37. doi:10.1016/j.sleep.2018.01.004
1. World Health Organization. Workload indicators of staffing need (WISN). https://www.who.int/hrh/resources/WISN_Eng_UsersManual.pdf?ua=1. Published December 2015. Accessed June 24, 2020.
2. American Association for Respiratory Care. Position statement: best practices in respiratory care productivity and staffing. https://www.aarc.org/wp-content/uploads/2017/03/statement-of-best-practices_productivity-and-staffing.pdf. Revised July 2015. Accessed June 24, 2020.
3. Wu DTY, Smart N, Ciemins EL, Lanham HJ, Lindberg C, Zheng K. Using EHR audit trail logs to analyze clinical workflow: a case study from community-based ambulatory clinics. AMIA Annu Symp Proc. 2018;2017:1820-1827. Published 2018 Apr 16.
4. US Department of Veterans Affairs, Veterans Health Administration. https://www.va.gov/health.
5. Cohen T. VA crisis: solutions exist, but haven’t happened, panel hears. https://www.cnn.com/2014/06/12/politics/va-reforms/index.html. Published June 12, 2014. Accessed June 24, 2020.
6. Richardson B. IG probes uncover more problems at VA hospitals. https://thehill.com/policy/defense/258652-ig-probes-uncover-more-problems-at-va-hospitals. Published October 30, 2015. Accessed June 24, 2020.
7. Slack D. Inaccurate VA wait times prelude thousands of vets from getting outside care, probe finds. USA Today. March 3, 2017. https://www.usatoday.com/story/news/politics/2017/03/03/veterans-affairs-inspector-general-widespread-inaccuracies-wait-times/98693856. Accessed June 24, 2020.
8. US Department of Veterans Affairs, Office of the Inspector General. Veterans Health Administration: audit of physician staffing levels for specialty care services. https://www.va.gov/oig/pubs/VAOIG-11-01827-36.pdf. Published December 27, 2012. Accessed June 24, 2020.
9. Government Accountability Office. VA health care: improvements needed in data and monitoring of clinical productivity and efficiency. https://www.gao.gov/assets/690/684869.pdf. Published May 2017. Accessed June 24, 2020.
10. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1082. Patient care data capture. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3091. Published March 24, 2015. Accessed June 24, 2020.
11. US Department of Veterans Affairs, Veterans Health Administration. VHA Handbook 1006.02. VHA site classifications and definitions. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2970. Published December 30, 2013. Accessed June 24, 2020.
12. Alexander M, Ray MA, Hébert JR, et al. The National Veteran Sleep Disorder Study: Descriptive Epidemiology and Secular Trends, 2000-2010. Sleep. 2016;39(7):1399-1410. Published 2016 Jul 1. doi:10.5665/sleep.5972.
13. A Caldwell J, Knapik JJ, Lieberman HR. Trends and factors associated with insomnia and sleep apnea in all United States military service members from 2005 to 2014. J Sleep Res. 2017;26(5):665-670. doi:10.1111/jsr.12543
14. Klingaman EA, Brownlow JA, Boland EM, Mosti C, Gehrman PR. Prevalence, predictors and correlates of insomnia in US army soldiers. J Sleep Res. 2018;27(3):e12612. doi:10.1111/jsr.12612
15. Sharafkhaneh A, Richardson P, Hirshkowitz M. Sleep apnea in a high risk population: a study of Veterans Health Administration beneficiaries. Sleep Med. 2004;5(4):345-350. doi:10.1016/j.sleep.2004.01.019.
16. Sarmiento KF, Folmer RL, Stepnowsky CJ, et al. National Expansion of Sleep Telemedicine for Veterans: The TeleSleep Program. J Clin Sleep Med. 2019;15(9):1355-1364. doi:10.5664/jcsm.7934
17. Van Dongen HP, Maislin G, Mullington JM, Dinges DF. The cumulative cost of additional wakefulness: dose-response effects on neurobehavioral functions and sleep physiology from chronic sleep restriction and total sleep deprivation [published correction appears in Sleep. 2004 Jun 15;27(4):600]. Sleep. 2003;26(2):117-126. doi:10.1093/sleep/26.2.117
18. Johnson EO, Roth T, Breslau N. The association of insomnia with anxiety disorders and depression: exploration of the direction of risk. J Psychiatr Res. 2006;40(8):700-708. doi:10.1016/j.jpsychires.2006.07.008
19. Léger D, Bayon V, Ohayon MM, et al. Insomnia and accidents: cross-sectional study (EQUINOX) on sleep-related home, work and car accidents in 5293 subjects with insomnia from 10 countries. J Sleep Res. 2014;23(2):143-152. doi:10.1111/jsr.12104
20. Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015;7(8):1311-1322. doi:10.3978/j.issn.2072-1439.2015.06.11
21. Javaheri S, Redline S. Insomnia and Risk of Cardiovascular Disease. Chest. 2017;152(2):435-444. doi:10.1016/j.chest.2017.01.026
22. Linz D, McEvoy RD, Cowie MR, et al. Associations of obstructivesSleepaApnea with atrial fibrillation and continuous positive airway pressure treatment: a review. JAMA Cardiol. 2018;3(6):532-540. doi:10.1001/jamacardio.2018.0095
23. Ogilvie RP, Lakshminarayan K, Iber C, Patel SR, Lutsey PL. Joint effects of OSA and self-reported sleepiness on incident CHD and stroke. Sleep Med. 2018;44:32-37. doi:10.1016/j.sleep.2018.01.004
Scalp Wound Closures in Mohs Micrographic Surgery: A Survey of Staples vs Sutures
Limited data exist comparing staples and sutures for scalp closures during Mohs micrographic surgery (MMS). As a result, the closure method for these scalp wounds is based on surgeon preference without established consensus. The purpose of this study was to survey practicing Mohs surgeons on their scalp wound closure preferences as well as the clinical and economic variables that impact their decisions. Understanding practice habits can guide future trial design, with a goal of creating established criterion for MMS scalp wound closures.
Methods
An anonymous survey was distributed from April 2019 to June 2019 to fellowship-trained Mohs surgeons using an electronic mailing list from the American College of Mohs Surgery (ACMS). The 10-question survey was approved by the University of Kansas institutional review board and the executive committee of the ACMS. Surgeons were asked about their preferred method for scalp wound closure as well as clinical and economic variables that impacted those preferences. Respondents indicated their frequency of using deep sutures, epidermal sutures, and wound undermining on a sliding scale of 0% to 100%. Comparisons were made between practice habits, preferences, and surgeon demographics using t tests. Statistical significance was determined as P<.05.
Results
Sixty-eight ACMS fellowship-trained Mohs surgeons completed the survey. The average age of respondents was 45 years; 69.1% (n=47) of respondents were male, and 76.5% (n=52) practiced in a private setting (Table 1). Regardless of epidermal closure type, deep suture placement was used in an average (standard deviation [SD]) of 88.8% (19.5%) of cases overall, which did not statistically differ between years of Mohs experience or practice setting (Table 2). Wound undermining was performed in an average (SD) of 83.0% (24.3%) of cases overall and was more prevalent in private vs academic settings (87.6% [17.8%] vs 65.7% [35.0%]; P<.01). Epidermal sutures were used in an average (SD) of 27.1% (33.5%) of scalp wound cases overall. Surgeons with less experience (≤5 years) used them more frequently (average [SD], 42.7% [36.2%] of cases) than surgeons with more experience (≥16 years; average [SD], 18.8% [32.6%] of cases; P=.037). There was no significant difference between epidermal suture placement rates and practice setting (average [SD], 18.1% [28.1%] of cases for academic providers vs 30.0% [34.8%] of cases with private providers; P=.210).
Clinical and economic factors that were most important during wound closure were ranked (beginning with most important) as the following: risk of complications, cosmetic outcome, hair preservation, patient comfort during closure, healing time, and closure cost. In all demographic cases, risk of complications was ranked 1 or 2 (1=most important; 6=least important) overall; cost was the least important factor overall (Table 2).
Surgeons perceived staples to be superior for speed of closure and for closing wounds in high-tension areas, whereas sutures were perceived as superior when considering cost of closure and ease of removal (Table 3). Successful healing rate, healing time, hair preservation, overall cosmetic outcome, and lower risk of complications were viewed as equivalent when comparing staples and sutures.
In cases in which surgeons did not use staples for closure, the most important factors for opting to not use them were patient discomfort (52.9% [n=36]), cost (25.0% [n=17]), and worse overall cosmetic outcome (23.5% [n=16])(Table 4). The most frequent locations outside of scalp wounds that physicians considered the use of staples for closure were the back (19.1% [n=13]), thigh (10.3% [n=7]), and shoulder (8.8% [n=6]).
Comment
Epidermal closure with sutures was reportedly used in an average of only 27.1% of scalp wound cases, with clinical factors such as cosmetic outcome, risk of complications, and closure time seen as either equivalent or inferior to staples. Our data suggest that surgeon closure perceptions generally are in agreement with established head and neck literature within different medical specialties that favor staple closures, particularly in high-tension areas.1 Interestingly, the most common reasons given for not using staples included patient discomfort, cost, and worse cosmetic outcomes, which are unsubstantiated with head and neck comparative studies.2-4
Although cost was the least important variable for determining closure type in our surveyed cohort, it is likely that the overall cost of closure is frequently underestimated. A higher material cost is noted with staples; however, the largest determinant of overall cost remains the surgeon’s time, which is reduced by factors of 10 or more when closing with staples.2,3 This difference—coupled with the unchanged cosmetic outcome and complication rates—makes staples more advantageous for high-tension scalp wounds.4 Moreover, the stapling technique is more reproducible than suturing, which requires more surgical skill and experience.
Limitations of this study include a lack of directly comparable data for staple and suture scalp wound closures. In addition, the small cohort of respondents in this preliminary study can serve to guide future studies.
Conclusion
Scalp wounds during MMS were most frequently closed using staples vs sutures, with the perception that these methods are equivalent in complication risk, cosmetic outcome, and overall patient satisfaction. These results agree with comparative literature for head and neck surgery and assist with establishing an epidemiologic baseline for future studies comparing their use during MMS.
- Ritchie AJ, Rocke LG. Staples versus sutures in the closure of scalp wounds: a prospective, double-blind, randomized trial. Injury. 1989;20:217-218.
- Batra J, Bekal RK, Byadgi S, et al. Comparison of skin staples and standard sutures for closing incisions after head and neck cancer surgery: a double-blind, randomized and prospective study. J Maxillofac Oral Surg. 2016;15:243-250.
- Kanegaye JT, Vance CW, Chan L, et al. Comparison of skin stapling devices and standard sutures for pediatric scalp lacerations: a randomized study of cost and time benefits. J Pediatr. 1997;130:808-813.
- Khan ANGA, Dayan PS, Miller S, et al. Cosmetic outcome of scalp wound closure with staples in the pediatric emergency department: a prospective, randomized trial. Pediatr Emerg Care. 2002;18:171-173.
Limited data exist comparing staples and sutures for scalp closures during Mohs micrographic surgery (MMS). As a result, the closure method for these scalp wounds is based on surgeon preference without established consensus. The purpose of this study was to survey practicing Mohs surgeons on their scalp wound closure preferences as well as the clinical and economic variables that impact their decisions. Understanding practice habits can guide future trial design, with a goal of creating established criterion for MMS scalp wound closures.
Methods
An anonymous survey was distributed from April 2019 to June 2019 to fellowship-trained Mohs surgeons using an electronic mailing list from the American College of Mohs Surgery (ACMS). The 10-question survey was approved by the University of Kansas institutional review board and the executive committee of the ACMS. Surgeons were asked about their preferred method for scalp wound closure as well as clinical and economic variables that impacted those preferences. Respondents indicated their frequency of using deep sutures, epidermal sutures, and wound undermining on a sliding scale of 0% to 100%. Comparisons were made between practice habits, preferences, and surgeon demographics using t tests. Statistical significance was determined as P<.05.
Results
Sixty-eight ACMS fellowship-trained Mohs surgeons completed the survey. The average age of respondents was 45 years; 69.1% (n=47) of respondents were male, and 76.5% (n=52) practiced in a private setting (Table 1). Regardless of epidermal closure type, deep suture placement was used in an average (standard deviation [SD]) of 88.8% (19.5%) of cases overall, which did not statistically differ between years of Mohs experience or practice setting (Table 2). Wound undermining was performed in an average (SD) of 83.0% (24.3%) of cases overall and was more prevalent in private vs academic settings (87.6% [17.8%] vs 65.7% [35.0%]; P<.01). Epidermal sutures were used in an average (SD) of 27.1% (33.5%) of scalp wound cases overall. Surgeons with less experience (≤5 years) used them more frequently (average [SD], 42.7% [36.2%] of cases) than surgeons with more experience (≥16 years; average [SD], 18.8% [32.6%] of cases; P=.037). There was no significant difference between epidermal suture placement rates and practice setting (average [SD], 18.1% [28.1%] of cases for academic providers vs 30.0% [34.8%] of cases with private providers; P=.210).
Clinical and economic factors that were most important during wound closure were ranked (beginning with most important) as the following: risk of complications, cosmetic outcome, hair preservation, patient comfort during closure, healing time, and closure cost. In all demographic cases, risk of complications was ranked 1 or 2 (1=most important; 6=least important) overall; cost was the least important factor overall (Table 2).
Surgeons perceived staples to be superior for speed of closure and for closing wounds in high-tension areas, whereas sutures were perceived as superior when considering cost of closure and ease of removal (Table 3). Successful healing rate, healing time, hair preservation, overall cosmetic outcome, and lower risk of complications were viewed as equivalent when comparing staples and sutures.
In cases in which surgeons did not use staples for closure, the most important factors for opting to not use them were patient discomfort (52.9% [n=36]), cost (25.0% [n=17]), and worse overall cosmetic outcome (23.5% [n=16])(Table 4). The most frequent locations outside of scalp wounds that physicians considered the use of staples for closure were the back (19.1% [n=13]), thigh (10.3% [n=7]), and shoulder (8.8% [n=6]).
Comment
Epidermal closure with sutures was reportedly used in an average of only 27.1% of scalp wound cases, with clinical factors such as cosmetic outcome, risk of complications, and closure time seen as either equivalent or inferior to staples. Our data suggest that surgeon closure perceptions generally are in agreement with established head and neck literature within different medical specialties that favor staple closures, particularly in high-tension areas.1 Interestingly, the most common reasons given for not using staples included patient discomfort, cost, and worse cosmetic outcomes, which are unsubstantiated with head and neck comparative studies.2-4
Although cost was the least important variable for determining closure type in our surveyed cohort, it is likely that the overall cost of closure is frequently underestimated. A higher material cost is noted with staples; however, the largest determinant of overall cost remains the surgeon’s time, which is reduced by factors of 10 or more when closing with staples.2,3 This difference—coupled with the unchanged cosmetic outcome and complication rates—makes staples more advantageous for high-tension scalp wounds.4 Moreover, the stapling technique is more reproducible than suturing, which requires more surgical skill and experience.
Limitations of this study include a lack of directly comparable data for staple and suture scalp wound closures. In addition, the small cohort of respondents in this preliminary study can serve to guide future studies.
Conclusion
Scalp wounds during MMS were most frequently closed using staples vs sutures, with the perception that these methods are equivalent in complication risk, cosmetic outcome, and overall patient satisfaction. These results agree with comparative literature for head and neck surgery and assist with establishing an epidemiologic baseline for future studies comparing their use during MMS.
Limited data exist comparing staples and sutures for scalp closures during Mohs micrographic surgery (MMS). As a result, the closure method for these scalp wounds is based on surgeon preference without established consensus. The purpose of this study was to survey practicing Mohs surgeons on their scalp wound closure preferences as well as the clinical and economic variables that impact their decisions. Understanding practice habits can guide future trial design, with a goal of creating established criterion for MMS scalp wound closures.
Methods
An anonymous survey was distributed from April 2019 to June 2019 to fellowship-trained Mohs surgeons using an electronic mailing list from the American College of Mohs Surgery (ACMS). The 10-question survey was approved by the University of Kansas institutional review board and the executive committee of the ACMS. Surgeons were asked about their preferred method for scalp wound closure as well as clinical and economic variables that impacted those preferences. Respondents indicated their frequency of using deep sutures, epidermal sutures, and wound undermining on a sliding scale of 0% to 100%. Comparisons were made between practice habits, preferences, and surgeon demographics using t tests. Statistical significance was determined as P<.05.
Results
Sixty-eight ACMS fellowship-trained Mohs surgeons completed the survey. The average age of respondents was 45 years; 69.1% (n=47) of respondents were male, and 76.5% (n=52) practiced in a private setting (Table 1). Regardless of epidermal closure type, deep suture placement was used in an average (standard deviation [SD]) of 88.8% (19.5%) of cases overall, which did not statistically differ between years of Mohs experience or practice setting (Table 2). Wound undermining was performed in an average (SD) of 83.0% (24.3%) of cases overall and was more prevalent in private vs academic settings (87.6% [17.8%] vs 65.7% [35.0%]; P<.01). Epidermal sutures were used in an average (SD) of 27.1% (33.5%) of scalp wound cases overall. Surgeons with less experience (≤5 years) used them more frequently (average [SD], 42.7% [36.2%] of cases) than surgeons with more experience (≥16 years; average [SD], 18.8% [32.6%] of cases; P=.037). There was no significant difference between epidermal suture placement rates and practice setting (average [SD], 18.1% [28.1%] of cases for academic providers vs 30.0% [34.8%] of cases with private providers; P=.210).
Clinical and economic factors that were most important during wound closure were ranked (beginning with most important) as the following: risk of complications, cosmetic outcome, hair preservation, patient comfort during closure, healing time, and closure cost. In all demographic cases, risk of complications was ranked 1 or 2 (1=most important; 6=least important) overall; cost was the least important factor overall (Table 2).
Surgeons perceived staples to be superior for speed of closure and for closing wounds in high-tension areas, whereas sutures were perceived as superior when considering cost of closure and ease of removal (Table 3). Successful healing rate, healing time, hair preservation, overall cosmetic outcome, and lower risk of complications were viewed as equivalent when comparing staples and sutures.
In cases in which surgeons did not use staples for closure, the most important factors for opting to not use them were patient discomfort (52.9% [n=36]), cost (25.0% [n=17]), and worse overall cosmetic outcome (23.5% [n=16])(Table 4). The most frequent locations outside of scalp wounds that physicians considered the use of staples for closure were the back (19.1% [n=13]), thigh (10.3% [n=7]), and shoulder (8.8% [n=6]).
Comment
Epidermal closure with sutures was reportedly used in an average of only 27.1% of scalp wound cases, with clinical factors such as cosmetic outcome, risk of complications, and closure time seen as either equivalent or inferior to staples. Our data suggest that surgeon closure perceptions generally are in agreement with established head and neck literature within different medical specialties that favor staple closures, particularly in high-tension areas.1 Interestingly, the most common reasons given for not using staples included patient discomfort, cost, and worse cosmetic outcomes, which are unsubstantiated with head and neck comparative studies.2-4
Although cost was the least important variable for determining closure type in our surveyed cohort, it is likely that the overall cost of closure is frequently underestimated. A higher material cost is noted with staples; however, the largest determinant of overall cost remains the surgeon’s time, which is reduced by factors of 10 or more when closing with staples.2,3 This difference—coupled with the unchanged cosmetic outcome and complication rates—makes staples more advantageous for high-tension scalp wounds.4 Moreover, the stapling technique is more reproducible than suturing, which requires more surgical skill and experience.
Limitations of this study include a lack of directly comparable data for staple and suture scalp wound closures. In addition, the small cohort of respondents in this preliminary study can serve to guide future studies.
Conclusion
Scalp wounds during MMS were most frequently closed using staples vs sutures, with the perception that these methods are equivalent in complication risk, cosmetic outcome, and overall patient satisfaction. These results agree with comparative literature for head and neck surgery and assist with establishing an epidemiologic baseline for future studies comparing their use during MMS.
- Ritchie AJ, Rocke LG. Staples versus sutures in the closure of scalp wounds: a prospective, double-blind, randomized trial. Injury. 1989;20:217-218.
- Batra J, Bekal RK, Byadgi S, et al. Comparison of skin staples and standard sutures for closing incisions after head and neck cancer surgery: a double-blind, randomized and prospective study. J Maxillofac Oral Surg. 2016;15:243-250.
- Kanegaye JT, Vance CW, Chan L, et al. Comparison of skin stapling devices and standard sutures for pediatric scalp lacerations: a randomized study of cost and time benefits. J Pediatr. 1997;130:808-813.
- Khan ANGA, Dayan PS, Miller S, et al. Cosmetic outcome of scalp wound closure with staples in the pediatric emergency department: a prospective, randomized trial. Pediatr Emerg Care. 2002;18:171-173.
- Ritchie AJ, Rocke LG. Staples versus sutures in the closure of scalp wounds: a prospective, double-blind, randomized trial. Injury. 1989;20:217-218.
- Batra J, Bekal RK, Byadgi S, et al. Comparison of skin staples and standard sutures for closing incisions after head and neck cancer surgery: a double-blind, randomized and prospective study. J Maxillofac Oral Surg. 2016;15:243-250.
- Kanegaye JT, Vance CW, Chan L, et al. Comparison of skin stapling devices and standard sutures for pediatric scalp lacerations: a randomized study of cost and time benefits. J Pediatr. 1997;130:808-813.
- Khan ANGA, Dayan PS, Miller S, et al. Cosmetic outcome of scalp wound closure with staples in the pediatric emergency department: a prospective, randomized trial. Pediatr Emerg Care. 2002;18:171-173.
Practice Points
- Scalp wounds present a unique challenge for closure during Mohs micrographic surgery due to the scalp's tendency to bleed, limited elasticity, and hair-bearing nature.
- Among fellowship-trained Mohs surgeons, scalp wounds were closed with staples more often than with epidermal sutures.
- Staples and sutures for scalp wounds were perceived to be equivalent in risk of complications, cosmetic outcome, and overall patient satisfaction.
- Compared to epidermal sutures, staples were perceived as advantageous in high-tension areas and for speed of closure.
Laser Safety: The Need for Protocols
The use of lasers in dermatology has evolved and expanded since their first cutaneous use in 1963.1 As the fundamental understanding of the interaction of laser energy with biological tissues increased, the need for laser safety became apparent. Since then, lasers of varying wavelengths have been developed, each with its specific chromophore target and specific safety need. Protocols, such as a checklist, that have been shown to reduce adverse events in surgery and in the intensive care unit can be borrowed to decrease risk from laser injury and optimize laser safety in dermatology.2 The safety of the patient, the laser operator, and the other health care providers involved in the delivery of laser therapy led to the first US Food and Drug Administration (FDA) guidelines for laser use in 1984.3
There are 4 regulatory organizations for laser safety in the United States: the American National Standards Institute (ANSI), the Occupational Health and Safety Administration (OSHA), the FDA’s Center for Devices and Radiological Health, and The Joint Commission.
Laser Principles
The basic principles of lasers include transmission, absorption, scatter, and reflection, all occurring when laser light is applied to biological tissues. The effects of the laser are a function of the target tissue (the chromophore) and the wavelength of light being used.4 In the skin, there are 3 main endogenous chromophores: water, hemoglobin, and melanin. Some experts consider collagen to be a fourth and separate entity as a chromophore. Tattoos are considered exogenous chromophores.3 The basic principles of lasers are important to understand and keep in mind when discussing laser safety, as they are the mechanisms through which unintended consequences can occur.
Laser Safety
Ocular Hazards
Ocular hazards are a notable concern in laser surgery. The eye is uniquely susceptible to laser light, and eye injuries represent a majority of reported injuries, which can occur through direct beam, mirror reflection by surgical instruments, and beam reflection off the skin (4%–7% of light that hits the skin is reflected because of the refractive index between air and the stratum corneum).3 The different wavelengths of lasers affect different parts of the eye. The 3 parts of the eye affected most are the retina, cornea, and lens. Not only is the lens primarily at risk for acute (lenticular burns) and chronic (cataracts) injury from the laser, but secondarily the lens also can concentrate a laser beam onto the retina by a factor of 100,000 (Table 1).3
The use of ocular protective equipment, sometimes referred to as personal protective eyewear (PPE), is essential and is mandated by ANSI and OSHA for all class 3 and class 4 lasers. The eyewear must be labeled with the wavelength and the degree of optical protection—termed the optical density (OD) or filter factor—of each lens and should match the laser being used. Laser manufacturers, as required by ANSI, must provide the wavelength and OD of their lasers, and both can be found on each laser as well as in ANSI Z136.1.3
Vendors supplying PPE generally provide the material, usually glass or polycarbonate; color; visible light transmission, which is the actual amount of light that reaches one’s eye through the lens; filter specifications, which contain the OD at certain wavelengths; and the types of lasers for which each specific PPE is used. It is important to match the laser to the correct PPE. The use of multiple types of lasers in the same office or laser treatment area can present challenges regarding eye safety. Matching the PPE to the laser in use is critical, and therefore all steps to prevent error for patients and personnel should be employed. One recommendation is to place each laser in a separate room with the appropriate PPE hung outside on the door of that room.
When the treatment area is in the periocular region, protection of the patient’s cornea is essential. Leaded eye shields with nonreflective surfaces have been shown to offer the best protection.5 Prior to placement, anesthetic eye drops and lubrication are important for patient comfort and protection from corneal injury.
Laser-Generated Airborne Contaminants
Other hazards associated with laser use not directly related to the beam are laser-generated airborne contaminants (LGACs), including chemicals, viruses, bacteria, aerosolized blood products, and nanoparticles (<1 µm) known as ultrafine particles (UFPs). According to ANSI, electrosurgical devices and lasers generate the same smoke. The plume (surgical smoke) is known to contain as many as 60 chemicals, including but not limited to carbon monoxide, acrylonitrite, hydrocyanide, benzene, toluene, naphthalene, and formaldehyde. Several are known carcinogens, and others are environmental toxins.6,7
Smoke management is an important consideration for dermatologists and their patients and generally includes respiratory protection via masks and ventilation techniques. However, the practice is not universal, and oversight agencies such as OSHA and the National Institute for Occupational Safety and Health (NIOSH) provide guidelines only; they do not enforce. As such, smoke management is voluntary and not widely practiced. In a 2014 survey of 997 dermatologic surgeons who were asked if smoke management is used in their practice, 77% of respondents indicated no smoke management was used.6
The Surgical Plume: Composition
A 2014 study from the University of California, San Diego Department of Dermatology analyzed surgical smoke.6 The researchers placed the smoke collection probe 16 to 18 inches above the electrocautery site, which approximates the location of the surgeon’s head during the procedure. Assessing smoke composition, they found high levels of carcinogens and irritants. Two compounds found in their assay—1,3-butadiene and benzene—also are found in secondhand cigarette smoke. However, the concentrations in the plume were 17-fold higher for 1,3-butadiene and 10-fold higher for benzene than those found in secondhand cigarette smoke. The risk from chronic, long-term exposure to these airborne contaminants is notable, as benzene (a known carcinogen as determined by the US Department of Health and Human Services) is known to cause leukemia. For example, a busy Mohs surgeon can reach the equivalent of as many as 50 hours of continuous smoke exposure over the course of a year.6
The Surgical Plume: Particle Concentration
Ultrafine particles can bypass conventional filtering systems (surgical masks and N95 respirators) because of their extremely small size, which allows them to pass further into the lungs and all the way to the alveolar spaces. Geographic regions with high UFPs have been shown to have higher overall mortality rates, as well as higher rates of reactive airway disease, cardiovascular disease, and lung cancer. A 2016 study by Chuang et al7 published in JAMA Dermatology looked at the UFPs in the surgical plume from laser hair removal (LHR) procedures. The plume of LHR has a distinct odor and easily discernible particulates. The investigators measured the UFPs at the level of the laser practitioner and the patient’s face during LHR with a smoke evacuator turned on and again with it turned off for 30 seconds, and then compared them to UFPs measured in the treatment room, the waiting room, and outside the building. There were substantial increases in UFPs from the LHR procedure, especially for the laser practitioner, when the smoke evacuator was off. The ambient baseline particle count, as measured in the clinic waiting area, began at 15,300 particles per cubic centimeter (PPC), and once the LHR procedure began (smoke evacuator on), there was a greater than 8-fold PPC increase above baseline (15,300 PPC to 129,376 PPC) in UFPs measured for the laser practitioner. Importantly, during LHR when the smoke evacuator was turned off for 30 seconds, there was a more than 28-fold increase (15,300 PPC to 435,888 PPC) over baseline to the practitioner (Figure).7
The Surgical Plume: Viruses, Bacteria, and Aerosolized Blood Products
Viruses and bacteria are thought to be transmissible via the plume, and proviral human immunodeficiency virus DNA has been found in the plume as well as evacuator equipment used to reduce plume exposure.8 A study from 1988 found that CO2 laser users treating verrucae had human papillomavirus in the laser plume.9 A comparison study of CO2 laser users treating verrucae had an increased incidence of nasopharyngeal human papillomavirus infection when compared to a control group, and the plume also contained aerosolized blood.10 The American National Standards Institute, OSHA, and NIOSH all agree that LGAC control from lasers is necessary through respiratory protection and ventilation, but none of these organizations provides specific equipment recommendations. The American Society for Laser Medicine and Surgery has published a position statement on laser plume.11
The Surgical Plume: Smoke Management
Many virus particles and UFPs are less than 0.1 µm in size. It is important to note that neither surgical masks nor high-filtration masks, such as the N95 respirator, filter particles smaller than 0.1 µm. The first line of defense in smoke management is the local exhaust ventilation (LEV) system, which includes wall suction and/or a smoke evacuator. The smoke evacuator is considered the more important of the two. General filtration, such as wall suction, is a low-flow system and is really used for liquids. It can be used as a supplement to the smoke evacuator to control small amounts of plume if fitted with an in-line filter. There are 2 types of LEV filters: ultralow particulate air filters filter particles larger than 0.1
Of utmost importance when using a smoke evacuator system is suction tip placement. Placing the suction tip 1 cm from the tissue damage site has been shown to be 98.6% effective at removing laser plume. If moved to 2 cm, effectiveness decreases to less than 50%.11 Proper management recommendations based on current evidence suggest that use of a smoke evacuator and an approved fit-tested N95 respirator might provide maximum protection.6 In addition to plume exposure, tissue splatter can occur, especially during ablative (CO2) and tattoo laser therapy, which should prompt consideration of a face shield.11 There are several vendors and models available online, and a simple Internet search for surgical tissue splatter face shields will provide multiple options.
The standard surgical mask is not NIOSH approved and only effectively (99%) filters particles larger than 5 µm (vs 25% efficacy for 0.3-µm particles). Its main purpose is to protect the patient from the wearer.12
High-filtration masks, which capture particles as small as 0.1 µm, should be used instead. The surgical N95 respirator is a NIOSH-certified respirator and is recommended for use in cases when smoke management is necessary. The FDA does not test or certify these masks; it only clears them after reviewing manufacturer test data. Technically, to be called a surgical mask, it must be cleared by the FDA.12 The 95 of N95 indicates filter efficiency ratings of 95% when testing the filter efficiency using particles of approximately 0.3 µm in diameter (Table 2).13 Because 77% of surgical smoke particles are smaller than 1.1 µm, surgical masks and N95 respirators are never sufficient as stand-alone protection.14 An LEV system is much more important for safe surgical smoke management. However, recommendations call for the use of a smoke evacuator and a high-filtration mask together to obtain the most protection available.14
Fire Hazards
Fire hazards constitute another area of concern for the laser user and are seen with class 4 lasers. There usually are 2 types of fire hazards: electrical fires inside the laser (often faulty wiring) and flash fires (laser beam contacts flammable material). Flammable materials (eg, hair, hair products, makeup, fabrics, plastic, alcohol, chlorhexidine, aluminum chloride, elastic strap on safety goggles, gauze, drapes) should be identified and removed prior to laser use. CO2 and erbium:YAG lasers tend to pose the worst risk for flash fires.15
Precautions for fire control in the laser room should include fire extinguishers and/or fire extinguisher blankets, a water basin, and fire-resistant drapes available as needed. Flammable material such as gauze should be kept wet, or a nonflammable version should be used.3
Additional Safety Considerations
Whenever lasers are being used, it is important to cover any windows in the laser treatment area (LTA) to prevent the laser beam from passing through the glass window. Laser-blocking window covers are a requirement and are available from several vendors. Covers that block every laser class are available and come as a shade or a flat cover that is attached with Velcro or magnets. They also come with “Laser in Use” warning signs for additional safety. Access to the LTA when the laser is in use should be controlled and appropriate warning signs placed on the door to prevent inadvertent entry without proper PPE. Locking the door to the LTA while using the laser is an additional safety measure and can be included on a checklist.
For the dermatologist, the skin is a primary focus, and similar to the eye, can be at risk for injury. The most common type of injury resembles a sunburn, such as those seen in the UVB range, that appears as redness and sometimes blistering,15 which is an important consideration, and attention should be given to all those in the laser room.
Checklists
Checklists are ubiquitous throughout many occupations and many medical specialties. Their usefulness in preventing adverse events is well established. Any patient-provider encounter in which a series of sequential actions is required is a perfect situation for a checklist. In dermatologic laser surgery where the eye is uniquely susceptible to injury, a laser safety checklist is essential. Additionally, there are issues with LGACs and fire that are important to consider. Having protocols (ie, a checklist) in place that address these safety issues has been shown to reduce adverse outcomes.2 There are a number of templates available from various sources that can be customized to the laser treatment area. We provide a modifiable example (Table 3).
Conclusion
Laser usage in dermatologic surgery has increased. According to surveys from the American Society for Dermatologic Surgery, in 2012 there were approximately 2 million laser/light/energy-based procedures performed. By 2017, there were 3.27 million, up from 2.79 million in 2016, representing an approximate 1-year increase of 17%.16 Lasers have allowed interventions for skin, vascular, and aesthetic conditions that were once untreatable. As their use increases in number and broadens in scope, there also has been an increase in litigation alleging malpractice for misuse of the laser.17 Adverse events, which include photochemical or thermal injuries to the skin, pigmentation issues, scarring, plume-related issues, and fires, do occur. One solution to reduce the chance of an adverse outcome is to implement a checklist. Research using checklists has shown that adverse events are reduced when checklists are created and implemented properly. Improving checklist compliance also improves patient outcomes.17 The American National Standards Institute, in their ANSI Z136 series, and the World Health Organization provide checklist templates. We include our checklist for use in laser surgery (Table 3). Understanding that each laser treatment area is unique, the templates can serve as a starting point and can then be customized to suit the needs of each dermatologist.
- Goldman L, Blaney DJ, Kindel DJ, et al. Effect of the laser beam on the skin. J Invest Dermatol. 1963;40:121-122.
- Daggett C, Daggett A. The surgical check list revisited. Int J Surg Res Pract. 2017;4:051.
- Pritzker RN, Rohrer TE. Laser safety: standards and guidelines. In: Nouri K, ed. Handbook of Lasers in Dermatology. London, England: Springer; 2014:11-28.
- Husain Z, Alster TS. The role of lasers and intense pulsed light technology in dermatology. Clin Cosmet Investig Dermatol. 2016;9:29-40.
- Ries WR, Clymer MA, Reinisch L. Laser safety features of eye shields. Lasers Surg Med. 1996;18:309-315.
- Oganesyan G, Eimputh S, Kim SS, et al. Surgical smoke detection in dermatologic surgery. Dermatol Surg. 2014;40:1373-1377.
- Chuang GS, Farinelli W, Christiani DC, et al. Gaseous and particulate content of laser hair removal plume. JAMA Dermatol. 2016;152:1320-1326.
- Baggish MS, Poiesz BJ, Joret D, et al. Presence of human immunodeficiency DNA in laser smoke. Lasers Surg Med. 1991;11:197-203.
- Garden JM, O’Banion MK, Shelnitz LS, et al. Papilloma virus in the vapor of carbon dioxide laser-treated verrucae. JAMA. 1988;259:1199-1202.
- Gloster HM Jr, Roenigk RK. Risk of acquiring human papillomavirus from the plume produced by the carbon dioxide laser in the treatment of warts. J Am Acad Dermatol. 1995;32:436-441.
- American Society for Laser Medicine and Surgery. ASLMS laser and energy device plume position statement. http://www.aslms.org/for-professionals/professional-resources/safety-and-complications/aslms-laser-and-energy-device-plume-position-statement. Accessed October 4, 2019.
- A comparison of surgical masks, surgical N95 respirators, and industrial N95 respirators. OH&S website. https://ohsonline.com/Articles/2014/05/01/Comparison-Respiratory.aspx?Page=3. Published May 1, 2014. Accessed October 4, 2019.
- 3M Infection Prevention N95 particulate respirators, 1860/1860s and 1870. Frequently Asked Questions. http://multimedia.3m.com/mws/media/323208O/n95-particulate-respirators-1860-1860s-1870-faqs.pdf. Accessed October 4, 2019.
- Lewin JM, Brauer JA, Ostad A. Surgical smoke and the dermatologist. J Am Acad Dermatol. 2011;65:636-641.
- Arefiev K, Warycha M, Whiting D, et al. Flammability of topical preparations and surgical dressings in cutaneous and laser surgery: a controlled simulation study. J Am Acad Dermatol. 2012;67:700-705.
- ASDS survey on dermatologic procedures. American Society for Dermatologic Surgery website. https://www.asds.net/Medical-Professionals/Practice-Resources/ASDS-Survey-on-Dermatologic-Procedures. Accessed October 4, 2019.
- Jalian HR, Jalian CA, Avram MM. Common causes of injury and legal action in laser surgery. JAMA Dermatol. 2013;149:188-193.
The use of lasers in dermatology has evolved and expanded since their first cutaneous use in 1963.1 As the fundamental understanding of the interaction of laser energy with biological tissues increased, the need for laser safety became apparent. Since then, lasers of varying wavelengths have been developed, each with its specific chromophore target and specific safety need. Protocols, such as a checklist, that have been shown to reduce adverse events in surgery and in the intensive care unit can be borrowed to decrease risk from laser injury and optimize laser safety in dermatology.2 The safety of the patient, the laser operator, and the other health care providers involved in the delivery of laser therapy led to the first US Food and Drug Administration (FDA) guidelines for laser use in 1984.3
There are 4 regulatory organizations for laser safety in the United States: the American National Standards Institute (ANSI), the Occupational Health and Safety Administration (OSHA), the FDA’s Center for Devices and Radiological Health, and The Joint Commission.
Laser Principles
The basic principles of lasers include transmission, absorption, scatter, and reflection, all occurring when laser light is applied to biological tissues. The effects of the laser are a function of the target tissue (the chromophore) and the wavelength of light being used.4 In the skin, there are 3 main endogenous chromophores: water, hemoglobin, and melanin. Some experts consider collagen to be a fourth and separate entity as a chromophore. Tattoos are considered exogenous chromophores.3 The basic principles of lasers are important to understand and keep in mind when discussing laser safety, as they are the mechanisms through which unintended consequences can occur.
Laser Safety
Ocular Hazards
Ocular hazards are a notable concern in laser surgery. The eye is uniquely susceptible to laser light, and eye injuries represent a majority of reported injuries, which can occur through direct beam, mirror reflection by surgical instruments, and beam reflection off the skin (4%–7% of light that hits the skin is reflected because of the refractive index between air and the stratum corneum).3 The different wavelengths of lasers affect different parts of the eye. The 3 parts of the eye affected most are the retina, cornea, and lens. Not only is the lens primarily at risk for acute (lenticular burns) and chronic (cataracts) injury from the laser, but secondarily the lens also can concentrate a laser beam onto the retina by a factor of 100,000 (Table 1).3
The use of ocular protective equipment, sometimes referred to as personal protective eyewear (PPE), is essential and is mandated by ANSI and OSHA for all class 3 and class 4 lasers. The eyewear must be labeled with the wavelength and the degree of optical protection—termed the optical density (OD) or filter factor—of each lens and should match the laser being used. Laser manufacturers, as required by ANSI, must provide the wavelength and OD of their lasers, and both can be found on each laser as well as in ANSI Z136.1.3
Vendors supplying PPE generally provide the material, usually glass or polycarbonate; color; visible light transmission, which is the actual amount of light that reaches one’s eye through the lens; filter specifications, which contain the OD at certain wavelengths; and the types of lasers for which each specific PPE is used. It is important to match the laser to the correct PPE. The use of multiple types of lasers in the same office or laser treatment area can present challenges regarding eye safety. Matching the PPE to the laser in use is critical, and therefore all steps to prevent error for patients and personnel should be employed. One recommendation is to place each laser in a separate room with the appropriate PPE hung outside on the door of that room.
When the treatment area is in the periocular region, protection of the patient’s cornea is essential. Leaded eye shields with nonreflective surfaces have been shown to offer the best protection.5 Prior to placement, anesthetic eye drops and lubrication are important for patient comfort and protection from corneal injury.
Laser-Generated Airborne Contaminants
Other hazards associated with laser use not directly related to the beam are laser-generated airborne contaminants (LGACs), including chemicals, viruses, bacteria, aerosolized blood products, and nanoparticles (<1 µm) known as ultrafine particles (UFPs). According to ANSI, electrosurgical devices and lasers generate the same smoke. The plume (surgical smoke) is known to contain as many as 60 chemicals, including but not limited to carbon monoxide, acrylonitrite, hydrocyanide, benzene, toluene, naphthalene, and formaldehyde. Several are known carcinogens, and others are environmental toxins.6,7
Smoke management is an important consideration for dermatologists and their patients and generally includes respiratory protection via masks and ventilation techniques. However, the practice is not universal, and oversight agencies such as OSHA and the National Institute for Occupational Safety and Health (NIOSH) provide guidelines only; they do not enforce. As such, smoke management is voluntary and not widely practiced. In a 2014 survey of 997 dermatologic surgeons who were asked if smoke management is used in their practice, 77% of respondents indicated no smoke management was used.6
The Surgical Plume: Composition
A 2014 study from the University of California, San Diego Department of Dermatology analyzed surgical smoke.6 The researchers placed the smoke collection probe 16 to 18 inches above the electrocautery site, which approximates the location of the surgeon’s head during the procedure. Assessing smoke composition, they found high levels of carcinogens and irritants. Two compounds found in their assay—1,3-butadiene and benzene—also are found in secondhand cigarette smoke. However, the concentrations in the plume were 17-fold higher for 1,3-butadiene and 10-fold higher for benzene than those found in secondhand cigarette smoke. The risk from chronic, long-term exposure to these airborne contaminants is notable, as benzene (a known carcinogen as determined by the US Department of Health and Human Services) is known to cause leukemia. For example, a busy Mohs surgeon can reach the equivalent of as many as 50 hours of continuous smoke exposure over the course of a year.6
The Surgical Plume: Particle Concentration
Ultrafine particles can bypass conventional filtering systems (surgical masks and N95 respirators) because of their extremely small size, which allows them to pass further into the lungs and all the way to the alveolar spaces. Geographic regions with high UFPs have been shown to have higher overall mortality rates, as well as higher rates of reactive airway disease, cardiovascular disease, and lung cancer. A 2016 study by Chuang et al7 published in JAMA Dermatology looked at the UFPs in the surgical plume from laser hair removal (LHR) procedures. The plume of LHR has a distinct odor and easily discernible particulates. The investigators measured the UFPs at the level of the laser practitioner and the patient’s face during LHR with a smoke evacuator turned on and again with it turned off for 30 seconds, and then compared them to UFPs measured in the treatment room, the waiting room, and outside the building. There were substantial increases in UFPs from the LHR procedure, especially for the laser practitioner, when the smoke evacuator was off. The ambient baseline particle count, as measured in the clinic waiting area, began at 15,300 particles per cubic centimeter (PPC), and once the LHR procedure began (smoke evacuator on), there was a greater than 8-fold PPC increase above baseline (15,300 PPC to 129,376 PPC) in UFPs measured for the laser practitioner. Importantly, during LHR when the smoke evacuator was turned off for 30 seconds, there was a more than 28-fold increase (15,300 PPC to 435,888 PPC) over baseline to the practitioner (Figure).7
The Surgical Plume: Viruses, Bacteria, and Aerosolized Blood Products
Viruses and bacteria are thought to be transmissible via the plume, and proviral human immunodeficiency virus DNA has been found in the plume as well as evacuator equipment used to reduce plume exposure.8 A study from 1988 found that CO2 laser users treating verrucae had human papillomavirus in the laser plume.9 A comparison study of CO2 laser users treating verrucae had an increased incidence of nasopharyngeal human papillomavirus infection when compared to a control group, and the plume also contained aerosolized blood.10 The American National Standards Institute, OSHA, and NIOSH all agree that LGAC control from lasers is necessary through respiratory protection and ventilation, but none of these organizations provides specific equipment recommendations. The American Society for Laser Medicine and Surgery has published a position statement on laser plume.11
The Surgical Plume: Smoke Management
Many virus particles and UFPs are less than 0.1 µm in size. It is important to note that neither surgical masks nor high-filtration masks, such as the N95 respirator, filter particles smaller than 0.1 µm. The first line of defense in smoke management is the local exhaust ventilation (LEV) system, which includes wall suction and/or a smoke evacuator. The smoke evacuator is considered the more important of the two. General filtration, such as wall suction, is a low-flow system and is really used for liquids. It can be used as a supplement to the smoke evacuator to control small amounts of plume if fitted with an in-line filter. There are 2 types of LEV filters: ultralow particulate air filters filter particles larger than 0.1
Of utmost importance when using a smoke evacuator system is suction tip placement. Placing the suction tip 1 cm from the tissue damage site has been shown to be 98.6% effective at removing laser plume. If moved to 2 cm, effectiveness decreases to less than 50%.11 Proper management recommendations based on current evidence suggest that use of a smoke evacuator and an approved fit-tested N95 respirator might provide maximum protection.6 In addition to plume exposure, tissue splatter can occur, especially during ablative (CO2) and tattoo laser therapy, which should prompt consideration of a face shield.11 There are several vendors and models available online, and a simple Internet search for surgical tissue splatter face shields will provide multiple options.
The standard surgical mask is not NIOSH approved and only effectively (99%) filters particles larger than 5 µm (vs 25% efficacy for 0.3-µm particles). Its main purpose is to protect the patient from the wearer.12
High-filtration masks, which capture particles as small as 0.1 µm, should be used instead. The surgical N95 respirator is a NIOSH-certified respirator and is recommended for use in cases when smoke management is necessary. The FDA does not test or certify these masks; it only clears them after reviewing manufacturer test data. Technically, to be called a surgical mask, it must be cleared by the FDA.12 The 95 of N95 indicates filter efficiency ratings of 95% when testing the filter efficiency using particles of approximately 0.3 µm in diameter (Table 2).13 Because 77% of surgical smoke particles are smaller than 1.1 µm, surgical masks and N95 respirators are never sufficient as stand-alone protection.14 An LEV system is much more important for safe surgical smoke management. However, recommendations call for the use of a smoke evacuator and a high-filtration mask together to obtain the most protection available.14
Fire Hazards
Fire hazards constitute another area of concern for the laser user and are seen with class 4 lasers. There usually are 2 types of fire hazards: electrical fires inside the laser (often faulty wiring) and flash fires (laser beam contacts flammable material). Flammable materials (eg, hair, hair products, makeup, fabrics, plastic, alcohol, chlorhexidine, aluminum chloride, elastic strap on safety goggles, gauze, drapes) should be identified and removed prior to laser use. CO2 and erbium:YAG lasers tend to pose the worst risk for flash fires.15
Precautions for fire control in the laser room should include fire extinguishers and/or fire extinguisher blankets, a water basin, and fire-resistant drapes available as needed. Flammable material such as gauze should be kept wet, or a nonflammable version should be used.3
Additional Safety Considerations
Whenever lasers are being used, it is important to cover any windows in the laser treatment area (LTA) to prevent the laser beam from passing through the glass window. Laser-blocking window covers are a requirement and are available from several vendors. Covers that block every laser class are available and come as a shade or a flat cover that is attached with Velcro or magnets. They also come with “Laser in Use” warning signs for additional safety. Access to the LTA when the laser is in use should be controlled and appropriate warning signs placed on the door to prevent inadvertent entry without proper PPE. Locking the door to the LTA while using the laser is an additional safety measure and can be included on a checklist.
For the dermatologist, the skin is a primary focus, and similar to the eye, can be at risk for injury. The most common type of injury resembles a sunburn, such as those seen in the UVB range, that appears as redness and sometimes blistering,15 which is an important consideration, and attention should be given to all those in the laser room.
Checklists
Checklists are ubiquitous throughout many occupations and many medical specialties. Their usefulness in preventing adverse events is well established. Any patient-provider encounter in which a series of sequential actions is required is a perfect situation for a checklist. In dermatologic laser surgery where the eye is uniquely susceptible to injury, a laser safety checklist is essential. Additionally, there are issues with LGACs and fire that are important to consider. Having protocols (ie, a checklist) in place that address these safety issues has been shown to reduce adverse outcomes.2 There are a number of templates available from various sources that can be customized to the laser treatment area. We provide a modifiable example (Table 3).
Conclusion
Laser usage in dermatologic surgery has increased. According to surveys from the American Society for Dermatologic Surgery, in 2012 there were approximately 2 million laser/light/energy-based procedures performed. By 2017, there were 3.27 million, up from 2.79 million in 2016, representing an approximate 1-year increase of 17%.16 Lasers have allowed interventions for skin, vascular, and aesthetic conditions that were once untreatable. As their use increases in number and broadens in scope, there also has been an increase in litigation alleging malpractice for misuse of the laser.17 Adverse events, which include photochemical or thermal injuries to the skin, pigmentation issues, scarring, plume-related issues, and fires, do occur. One solution to reduce the chance of an adverse outcome is to implement a checklist. Research using checklists has shown that adverse events are reduced when checklists are created and implemented properly. Improving checklist compliance also improves patient outcomes.17 The American National Standards Institute, in their ANSI Z136 series, and the World Health Organization provide checklist templates. We include our checklist for use in laser surgery (Table 3). Understanding that each laser treatment area is unique, the templates can serve as a starting point and can then be customized to suit the needs of each dermatologist.
The use of lasers in dermatology has evolved and expanded since their first cutaneous use in 1963.1 As the fundamental understanding of the interaction of laser energy with biological tissues increased, the need for laser safety became apparent. Since then, lasers of varying wavelengths have been developed, each with its specific chromophore target and specific safety need. Protocols, such as a checklist, that have been shown to reduce adverse events in surgery and in the intensive care unit can be borrowed to decrease risk from laser injury and optimize laser safety in dermatology.2 The safety of the patient, the laser operator, and the other health care providers involved in the delivery of laser therapy led to the first US Food and Drug Administration (FDA) guidelines for laser use in 1984.3
There are 4 regulatory organizations for laser safety in the United States: the American National Standards Institute (ANSI), the Occupational Health and Safety Administration (OSHA), the FDA’s Center for Devices and Radiological Health, and The Joint Commission.
Laser Principles
The basic principles of lasers include transmission, absorption, scatter, and reflection, all occurring when laser light is applied to biological tissues. The effects of the laser are a function of the target tissue (the chromophore) and the wavelength of light being used.4 In the skin, there are 3 main endogenous chromophores: water, hemoglobin, and melanin. Some experts consider collagen to be a fourth and separate entity as a chromophore. Tattoos are considered exogenous chromophores.3 The basic principles of lasers are important to understand and keep in mind when discussing laser safety, as they are the mechanisms through which unintended consequences can occur.
Laser Safety
Ocular Hazards
Ocular hazards are a notable concern in laser surgery. The eye is uniquely susceptible to laser light, and eye injuries represent a majority of reported injuries, which can occur through direct beam, mirror reflection by surgical instruments, and beam reflection off the skin (4%–7% of light that hits the skin is reflected because of the refractive index between air and the stratum corneum).3 The different wavelengths of lasers affect different parts of the eye. The 3 parts of the eye affected most are the retina, cornea, and lens. Not only is the lens primarily at risk for acute (lenticular burns) and chronic (cataracts) injury from the laser, but secondarily the lens also can concentrate a laser beam onto the retina by a factor of 100,000 (Table 1).3
The use of ocular protective equipment, sometimes referred to as personal protective eyewear (PPE), is essential and is mandated by ANSI and OSHA for all class 3 and class 4 lasers. The eyewear must be labeled with the wavelength and the degree of optical protection—termed the optical density (OD) or filter factor—of each lens and should match the laser being used. Laser manufacturers, as required by ANSI, must provide the wavelength and OD of their lasers, and both can be found on each laser as well as in ANSI Z136.1.3
Vendors supplying PPE generally provide the material, usually glass or polycarbonate; color; visible light transmission, which is the actual amount of light that reaches one’s eye through the lens; filter specifications, which contain the OD at certain wavelengths; and the types of lasers for which each specific PPE is used. It is important to match the laser to the correct PPE. The use of multiple types of lasers in the same office or laser treatment area can present challenges regarding eye safety. Matching the PPE to the laser in use is critical, and therefore all steps to prevent error for patients and personnel should be employed. One recommendation is to place each laser in a separate room with the appropriate PPE hung outside on the door of that room.
When the treatment area is in the periocular region, protection of the patient’s cornea is essential. Leaded eye shields with nonreflective surfaces have been shown to offer the best protection.5 Prior to placement, anesthetic eye drops and lubrication are important for patient comfort and protection from corneal injury.
Laser-Generated Airborne Contaminants
Other hazards associated with laser use not directly related to the beam are laser-generated airborne contaminants (LGACs), including chemicals, viruses, bacteria, aerosolized blood products, and nanoparticles (<1 µm) known as ultrafine particles (UFPs). According to ANSI, electrosurgical devices and lasers generate the same smoke. The plume (surgical smoke) is known to contain as many as 60 chemicals, including but not limited to carbon monoxide, acrylonitrite, hydrocyanide, benzene, toluene, naphthalene, and formaldehyde. Several are known carcinogens, and others are environmental toxins.6,7
Smoke management is an important consideration for dermatologists and their patients and generally includes respiratory protection via masks and ventilation techniques. However, the practice is not universal, and oversight agencies such as OSHA and the National Institute for Occupational Safety and Health (NIOSH) provide guidelines only; they do not enforce. As such, smoke management is voluntary and not widely practiced. In a 2014 survey of 997 dermatologic surgeons who were asked if smoke management is used in their practice, 77% of respondents indicated no smoke management was used.6
The Surgical Plume: Composition
A 2014 study from the University of California, San Diego Department of Dermatology analyzed surgical smoke.6 The researchers placed the smoke collection probe 16 to 18 inches above the electrocautery site, which approximates the location of the surgeon’s head during the procedure. Assessing smoke composition, they found high levels of carcinogens and irritants. Two compounds found in their assay—1,3-butadiene and benzene—also are found in secondhand cigarette smoke. However, the concentrations in the plume were 17-fold higher for 1,3-butadiene and 10-fold higher for benzene than those found in secondhand cigarette smoke. The risk from chronic, long-term exposure to these airborne contaminants is notable, as benzene (a known carcinogen as determined by the US Department of Health and Human Services) is known to cause leukemia. For example, a busy Mohs surgeon can reach the equivalent of as many as 50 hours of continuous smoke exposure over the course of a year.6
The Surgical Plume: Particle Concentration
Ultrafine particles can bypass conventional filtering systems (surgical masks and N95 respirators) because of their extremely small size, which allows them to pass further into the lungs and all the way to the alveolar spaces. Geographic regions with high UFPs have been shown to have higher overall mortality rates, as well as higher rates of reactive airway disease, cardiovascular disease, and lung cancer. A 2016 study by Chuang et al7 published in JAMA Dermatology looked at the UFPs in the surgical plume from laser hair removal (LHR) procedures. The plume of LHR has a distinct odor and easily discernible particulates. The investigators measured the UFPs at the level of the laser practitioner and the patient’s face during LHR with a smoke evacuator turned on and again with it turned off for 30 seconds, and then compared them to UFPs measured in the treatment room, the waiting room, and outside the building. There were substantial increases in UFPs from the LHR procedure, especially for the laser practitioner, when the smoke evacuator was off. The ambient baseline particle count, as measured in the clinic waiting area, began at 15,300 particles per cubic centimeter (PPC), and once the LHR procedure began (smoke evacuator on), there was a greater than 8-fold PPC increase above baseline (15,300 PPC to 129,376 PPC) in UFPs measured for the laser practitioner. Importantly, during LHR when the smoke evacuator was turned off for 30 seconds, there was a more than 28-fold increase (15,300 PPC to 435,888 PPC) over baseline to the practitioner (Figure).7
The Surgical Plume: Viruses, Bacteria, and Aerosolized Blood Products
Viruses and bacteria are thought to be transmissible via the plume, and proviral human immunodeficiency virus DNA has been found in the plume as well as evacuator equipment used to reduce plume exposure.8 A study from 1988 found that CO2 laser users treating verrucae had human papillomavirus in the laser plume.9 A comparison study of CO2 laser users treating verrucae had an increased incidence of nasopharyngeal human papillomavirus infection when compared to a control group, and the plume also contained aerosolized blood.10 The American National Standards Institute, OSHA, and NIOSH all agree that LGAC control from lasers is necessary through respiratory protection and ventilation, but none of these organizations provides specific equipment recommendations. The American Society for Laser Medicine and Surgery has published a position statement on laser plume.11
The Surgical Plume: Smoke Management
Many virus particles and UFPs are less than 0.1 µm in size. It is important to note that neither surgical masks nor high-filtration masks, such as the N95 respirator, filter particles smaller than 0.1 µm. The first line of defense in smoke management is the local exhaust ventilation (LEV) system, which includes wall suction and/or a smoke evacuator. The smoke evacuator is considered the more important of the two. General filtration, such as wall suction, is a low-flow system and is really used for liquids. It can be used as a supplement to the smoke evacuator to control small amounts of plume if fitted with an in-line filter. There are 2 types of LEV filters: ultralow particulate air filters filter particles larger than 0.1
Of utmost importance when using a smoke evacuator system is suction tip placement. Placing the suction tip 1 cm from the tissue damage site has been shown to be 98.6% effective at removing laser plume. If moved to 2 cm, effectiveness decreases to less than 50%.11 Proper management recommendations based on current evidence suggest that use of a smoke evacuator and an approved fit-tested N95 respirator might provide maximum protection.6 In addition to plume exposure, tissue splatter can occur, especially during ablative (CO2) and tattoo laser therapy, which should prompt consideration of a face shield.11 There are several vendors and models available online, and a simple Internet search for surgical tissue splatter face shields will provide multiple options.
The standard surgical mask is not NIOSH approved and only effectively (99%) filters particles larger than 5 µm (vs 25% efficacy for 0.3-µm particles). Its main purpose is to protect the patient from the wearer.12
High-filtration masks, which capture particles as small as 0.1 µm, should be used instead. The surgical N95 respirator is a NIOSH-certified respirator and is recommended for use in cases when smoke management is necessary. The FDA does not test or certify these masks; it only clears them after reviewing manufacturer test data. Technically, to be called a surgical mask, it must be cleared by the FDA.12 The 95 of N95 indicates filter efficiency ratings of 95% when testing the filter efficiency using particles of approximately 0.3 µm in diameter (Table 2).13 Because 77% of surgical smoke particles are smaller than 1.1 µm, surgical masks and N95 respirators are never sufficient as stand-alone protection.14 An LEV system is much more important for safe surgical smoke management. However, recommendations call for the use of a smoke evacuator and a high-filtration mask together to obtain the most protection available.14
Fire Hazards
Fire hazards constitute another area of concern for the laser user and are seen with class 4 lasers. There usually are 2 types of fire hazards: electrical fires inside the laser (often faulty wiring) and flash fires (laser beam contacts flammable material). Flammable materials (eg, hair, hair products, makeup, fabrics, plastic, alcohol, chlorhexidine, aluminum chloride, elastic strap on safety goggles, gauze, drapes) should be identified and removed prior to laser use. CO2 and erbium:YAG lasers tend to pose the worst risk for flash fires.15
Precautions for fire control in the laser room should include fire extinguishers and/or fire extinguisher blankets, a water basin, and fire-resistant drapes available as needed. Flammable material such as gauze should be kept wet, or a nonflammable version should be used.3
Additional Safety Considerations
Whenever lasers are being used, it is important to cover any windows in the laser treatment area (LTA) to prevent the laser beam from passing through the glass window. Laser-blocking window covers are a requirement and are available from several vendors. Covers that block every laser class are available and come as a shade or a flat cover that is attached with Velcro or magnets. They also come with “Laser in Use” warning signs for additional safety. Access to the LTA when the laser is in use should be controlled and appropriate warning signs placed on the door to prevent inadvertent entry without proper PPE. Locking the door to the LTA while using the laser is an additional safety measure and can be included on a checklist.
For the dermatologist, the skin is a primary focus, and similar to the eye, can be at risk for injury. The most common type of injury resembles a sunburn, such as those seen in the UVB range, that appears as redness and sometimes blistering,15 which is an important consideration, and attention should be given to all those in the laser room.
Checklists
Checklists are ubiquitous throughout many occupations and many medical specialties. Their usefulness in preventing adverse events is well established. Any patient-provider encounter in which a series of sequential actions is required is a perfect situation for a checklist. In dermatologic laser surgery where the eye is uniquely susceptible to injury, a laser safety checklist is essential. Additionally, there are issues with LGACs and fire that are important to consider. Having protocols (ie, a checklist) in place that address these safety issues has been shown to reduce adverse outcomes.2 There are a number of templates available from various sources that can be customized to the laser treatment area. We provide a modifiable example (Table 3).
Conclusion
Laser usage in dermatologic surgery has increased. According to surveys from the American Society for Dermatologic Surgery, in 2012 there were approximately 2 million laser/light/energy-based procedures performed. By 2017, there were 3.27 million, up from 2.79 million in 2016, representing an approximate 1-year increase of 17%.16 Lasers have allowed interventions for skin, vascular, and aesthetic conditions that were once untreatable. As their use increases in number and broadens in scope, there also has been an increase in litigation alleging malpractice for misuse of the laser.17 Adverse events, which include photochemical or thermal injuries to the skin, pigmentation issues, scarring, plume-related issues, and fires, do occur. One solution to reduce the chance of an adverse outcome is to implement a checklist. Research using checklists has shown that adverse events are reduced when checklists are created and implemented properly. Improving checklist compliance also improves patient outcomes.17 The American National Standards Institute, in their ANSI Z136 series, and the World Health Organization provide checklist templates. We include our checklist for use in laser surgery (Table 3). Understanding that each laser treatment area is unique, the templates can serve as a starting point and can then be customized to suit the needs of each dermatologist.
- Goldman L, Blaney DJ, Kindel DJ, et al. Effect of the laser beam on the skin. J Invest Dermatol. 1963;40:121-122.
- Daggett C, Daggett A. The surgical check list revisited. Int J Surg Res Pract. 2017;4:051.
- Pritzker RN, Rohrer TE. Laser safety: standards and guidelines. In: Nouri K, ed. Handbook of Lasers in Dermatology. London, England: Springer; 2014:11-28.
- Husain Z, Alster TS. The role of lasers and intense pulsed light technology in dermatology. Clin Cosmet Investig Dermatol. 2016;9:29-40.
- Ries WR, Clymer MA, Reinisch L. Laser safety features of eye shields. Lasers Surg Med. 1996;18:309-315.
- Oganesyan G, Eimputh S, Kim SS, et al. Surgical smoke detection in dermatologic surgery. Dermatol Surg. 2014;40:1373-1377.
- Chuang GS, Farinelli W, Christiani DC, et al. Gaseous and particulate content of laser hair removal plume. JAMA Dermatol. 2016;152:1320-1326.
- Baggish MS, Poiesz BJ, Joret D, et al. Presence of human immunodeficiency DNA in laser smoke. Lasers Surg Med. 1991;11:197-203.
- Garden JM, O’Banion MK, Shelnitz LS, et al. Papilloma virus in the vapor of carbon dioxide laser-treated verrucae. JAMA. 1988;259:1199-1202.
- Gloster HM Jr, Roenigk RK. Risk of acquiring human papillomavirus from the plume produced by the carbon dioxide laser in the treatment of warts. J Am Acad Dermatol. 1995;32:436-441.
- American Society for Laser Medicine and Surgery. ASLMS laser and energy device plume position statement. http://www.aslms.org/for-professionals/professional-resources/safety-and-complications/aslms-laser-and-energy-device-plume-position-statement. Accessed October 4, 2019.
- A comparison of surgical masks, surgical N95 respirators, and industrial N95 respirators. OH&S website. https://ohsonline.com/Articles/2014/05/01/Comparison-Respiratory.aspx?Page=3. Published May 1, 2014. Accessed October 4, 2019.
- 3M Infection Prevention N95 particulate respirators, 1860/1860s and 1870. Frequently Asked Questions. http://multimedia.3m.com/mws/media/323208O/n95-particulate-respirators-1860-1860s-1870-faqs.pdf. Accessed October 4, 2019.
- Lewin JM, Brauer JA, Ostad A. Surgical smoke and the dermatologist. J Am Acad Dermatol. 2011;65:636-641.
- Arefiev K, Warycha M, Whiting D, et al. Flammability of topical preparations and surgical dressings in cutaneous and laser surgery: a controlled simulation study. J Am Acad Dermatol. 2012;67:700-705.
- ASDS survey on dermatologic procedures. American Society for Dermatologic Surgery website. https://www.asds.net/Medical-Professionals/Practice-Resources/ASDS-Survey-on-Dermatologic-Procedures. Accessed October 4, 2019.
- Jalian HR, Jalian CA, Avram MM. Common causes of injury and legal action in laser surgery. JAMA Dermatol. 2013;149:188-193.
- Goldman L, Blaney DJ, Kindel DJ, et al. Effect of the laser beam on the skin. J Invest Dermatol. 1963;40:121-122.
- Daggett C, Daggett A. The surgical check list revisited. Int J Surg Res Pract. 2017;4:051.
- Pritzker RN, Rohrer TE. Laser safety: standards and guidelines. In: Nouri K, ed. Handbook of Lasers in Dermatology. London, England: Springer; 2014:11-28.
- Husain Z, Alster TS. The role of lasers and intense pulsed light technology in dermatology. Clin Cosmet Investig Dermatol. 2016;9:29-40.
- Ries WR, Clymer MA, Reinisch L. Laser safety features of eye shields. Lasers Surg Med. 1996;18:309-315.
- Oganesyan G, Eimputh S, Kim SS, et al. Surgical smoke detection in dermatologic surgery. Dermatol Surg. 2014;40:1373-1377.
- Chuang GS, Farinelli W, Christiani DC, et al. Gaseous and particulate content of laser hair removal plume. JAMA Dermatol. 2016;152:1320-1326.
- Baggish MS, Poiesz BJ, Joret D, et al. Presence of human immunodeficiency DNA in laser smoke. Lasers Surg Med. 1991;11:197-203.
- Garden JM, O’Banion MK, Shelnitz LS, et al. Papilloma virus in the vapor of carbon dioxide laser-treated verrucae. JAMA. 1988;259:1199-1202.
- Gloster HM Jr, Roenigk RK. Risk of acquiring human papillomavirus from the plume produced by the carbon dioxide laser in the treatment of warts. J Am Acad Dermatol. 1995;32:436-441.
- American Society for Laser Medicine and Surgery. ASLMS laser and energy device plume position statement. http://www.aslms.org/for-professionals/professional-resources/safety-and-complications/aslms-laser-and-energy-device-plume-position-statement. Accessed October 4, 2019.
- A comparison of surgical masks, surgical N95 respirators, and industrial N95 respirators. OH&S website. https://ohsonline.com/Articles/2014/05/01/Comparison-Respiratory.aspx?Page=3. Published May 1, 2014. Accessed October 4, 2019.
- 3M Infection Prevention N95 particulate respirators, 1860/1860s and 1870. Frequently Asked Questions. http://multimedia.3m.com/mws/media/323208O/n95-particulate-respirators-1860-1860s-1870-faqs.pdf. Accessed October 4, 2019.
- Lewin JM, Brauer JA, Ostad A. Surgical smoke and the dermatologist. J Am Acad Dermatol. 2011;65:636-641.
- Arefiev K, Warycha M, Whiting D, et al. Flammability of topical preparations and surgical dressings in cutaneous and laser surgery: a controlled simulation study. J Am Acad Dermatol. 2012;67:700-705.
- ASDS survey on dermatologic procedures. American Society for Dermatologic Surgery website. https://www.asds.net/Medical-Professionals/Practice-Resources/ASDS-Survey-on-Dermatologic-Procedures. Accessed October 4, 2019.
- Jalian HR, Jalian CA, Avram MM. Common causes of injury and legal action in laser surgery. JAMA Dermatol. 2013;149:188-193.
Practice Points
- Laser therapy has evolved and expanded since its first cutaneous use in 1963.
- The 4 regulatory agencies for laser safety in the United States establish standards and guidelines, but implementation is voluntary.
- Ocular hazards, laser-generated airborne contaminants, fires, and unintended laser beam injuries constitute the main safety concerns.
- Safety protocols with a laser checklist can reduce adverse outcomes.
A Curriculum for Training Medical Faculty to Teach Mental Health Care—and Their Responses to the Learning
From Michigan State University, East Lansing, MI.
Abstract
- Objective: We previously reported that training medical faculty to teach mental health care to residents was effective. We here describe the faculty’s training curriculum and their responses to learning and teaching mental health care, a unique focus in the educational literature.
- Design: Qualitative researchers assessed the experiences of medical faculty trainees in learning and teaching mental health care.
- Setting: Internal medicine residency training program at Michigan State University.
- Participants: One early career medicine faculty learner and another faculty learner at mid-career, 4 faculty trainers, and 2 qualitative researchers.
- Measurements: Typed qualitative research reports were evaluated by the authors from 4 time periods: (1) following didactic and interviewing training; (2) following training in a mental health clinic; (3) following training to teach residents mental health care; and (4) 8 months after training.
- Results: Faculty expressed anxiety and low confidence at each of 3 levels of training, but progressively developed confidence and satisfaction during training at each level. They rated didactic experiences as least valuable, seeing these experiences as lacking practical application. Experiential training in interviewing and mental health care were positively viewed, as was the benefit from mentoring. Teaching mental health skills to residents was initially difficult, but faculty became comfortable with experience, which solidified the faculty’s confidence in their own skills.
- Conclusion: A new curriculum for training medical faculty to teach mental health care was demonstrated to be acceptable to the faculty, based on findings from multiple focus groups.
Keywords: psychiatry; primary care mental health; medical education; curriculum; formative evaluation.
We previously trained general medicine faculty intensively in 3 evidence-based models essential for mental health care.1-4 They, in turn, trained medical residents in the models over all 3 years of residency training.5 The results of this quasi-experimental trial demonstrated highly significant learning by residents on all 3 models.6 To address the mental health care crisis caused by the severe shortage of psychiatrists in the United States,7-14 we propose this train-the-trainer intervention as a model for widescale training of medical faculty in mental health care, thus enabling them to then train their own residents and students indefinitely.6
This brief report details the faculty training curriculum in mental health care and its teaching, along with the responses of medical faculty to the training; no similar training experiences have been reported in the medical or psychiatric literature. While the residency training curriculum has been published,5 the faculty training curriculum has not. Additionally, faculty responses to the training are important because they can provide key information about what did and did not work. Even though demonstrated to be effective for teaching mental health care to residents,6 the training must also be acceptable to its new teachers.15
Methods
Design, Setting, and Participants
This descriptive study was conducted by 2 experienced qualitative researchers in the setting of a 5-year quantitative study of residents’ learning of mental health care.5,6 They interviewed 2 general medicine faculty undergoing training in mental health care on 4 occasions: 3 times during training and once following training. Learners were taught by 4 faculty trainers (2 general medicine, 2 psychiatry). The setting was the internal medicine residency program at Michigan State University. The project was approved by the local Institutional Review Board.
Faculty Training Intervention
The 2 training faculty evaluated in this study were taught in a predominantly experiential way.5 Learning objectives were behaviorally defined (see Table 1, which also presents the teaching methods). Teaching occurred in 3 segments over 15 months, with a 10% weekly commitment to training supported by a research grant.
First 6 Months. For 1 half-day (4 hours) every week, teaching sessions were divided into 2 parts:
1. Experiential learning of the objectives, particularly patient-centered interviewing (Table 2)16 and mental health care models (Table 3).3,17 This initially involved role playing and was followed by using the models with hospital and clinic patients, sometimes directly observed, other times evaluated via audiotaped recordings.
2. Lecture and reading series, which occurred in 2 parts: (a) For the first 3 months, a biopsychosocial and patient-centered medicine seminar was guided by readings from a patient-centered interviewing textbook and 4 articles.3,16,18-20 These readings were supplemented by a large collection of material on our website that was utilized in a learner-centered fashion, depending on learners’ interests (these are available from the authors, along with a detailed outline we followed for each teaching session). (b) For the last 3 months, a psychiatry lecture series addressed the material needed for primary care mental health. The lectures were guided by a psychiatry textbook (the schedule and content of presentations is available from the authors).21
Beginning in the first 6 months, faculty also participated as co-teachers with their trainers in a long-standing psychosocial rotation, a 1-month full-time rotation for PGY-1 residents that occurred twice yearly during training. This initially helped them learn the models, and they later received experience in how to teach the models.
Middle 4 Months. During this period, faculty learners were supervised by trainers as they transitioned to learn mental health care in a Complex Patient Clinic (CPC). Training was guided by a syllabus now contained in a textbook.17 The CPC is a unique mental health care clinic located in the clinic area where faculty and residents observe other patients. Rooms resemble other exam rooms, except they have a computer attached to an audio-video camera that delivers the physician-patient interaction live to another room, where faculty observe it via a software program (Vidyo, Hackensack, NJ)22,23; no recordings are made of the live interactions. The details of patient recruitment and the CPC are described elsewhere.22 CPC patients had an average of 2.3 DSM-V diagnoses and 3.3 major medical diagnoses. Faculty trainees evaluated 2 or 3 patients each day.
Final 5 Months. Supervision continued for faculty learners as they taught mental health care to postgraduate year (PGY) 2 and 3 residents in the CPC. Residents had between 6 and 8 sessions in each of their last 2 years of training; 2 residents were assigned for each half-day CPC session and each evaluated 2 or 3 patients under faculty-learner supervision.
Data Collection
The qualitative interviewers were independent of the study. The research team members did not see the transcripts until preparing this report in conjunction with the interviewers. Data were collected from faculty at 4 points: following the initial 6 months of training in the models; following training in mental health care in the CPC; following supervision of faculty training of residents; and 8 months following completion of training, during which time they independently taught residents.
Data were collected in a systematic way over 1 hour, beginning and continuing open-endedly for about 30 minutes and concluding with closed-ended inquiry to pin down details and to ask any pre-planned questions that had not been answered. The protocol that guided focus group interviews is available from the authors.
Audio recordings were made from each group, and a 500- to 1000-word report was written by the interviewers, which served as the basis of the present descriptive evaluation. The authors independently analyzed the data at each collection point and then came to the consensus that follows.
Results
Lectures/Didactic Training
The training sessions involved 2 parts: lectures and didactic material around interviewing, general system theory, and psychiatry diagnoses; and skills practice in interviewing and the mental health care models. The trainers and faculty met weekly for 4 hours, and the first 2 hours of these sessions were spent reviewing the background of what would become the mainstay of the teaching, the models for interviewing and mental health care (Table 2 and Table 3). These readings differed in content and style from the typical clinical readings that physicians use, and they required considerable outside time and preparation, beyond that anticipated by the trainees. Digging into these theoretical concepts was described as interesting and “refreshing,” but the trainees at first found the readings disconnected from their clinical work. Faculty trainees later recognized the importance of understanding the models as they prepared for their roles as teachers. All told, however, the trainees believed there was too much didactic material.
Receiving education on diagnosis and management of common psychiatric disorders from academic psychiatrists was appreciated, but the trainees also expressed the greatest frustrations about this part of the curriculum. They felt that the level of these sessions was not always appropriately gauged—ranging from too simplistic, as in medical school, to too detailed, especially around neurochemical and neurobiological mechanisms. Although they appreciated learning about advanced psychiatric illness and treatments (eg, electroconvulsive treatment, especially), they did not believe the information was necessary in primary care. Trainees were experienced primary care providers and were more interested in case-based education that could highlight the types of patients seen in their office every day. One trainee indicated that these sessions were lacking “the patient voice.” Abstract discussion of diagnoses and treatments made it challenging to apply this new knowledge to the trainees’ practices. Trainees also suggested trying to integrate this section of the training with the interviewing skills training to better highlight that interplay. The trainees believed that their understanding and familiarity with the diagnosis and management of mental disorders occurred primarily in later CPC training. The trainees recommended that all didactic material be reduced by half or more in future teaching.
Skills Practice
The patient-centered interviewing skills practice, which occurred in the second 2-hour period during the first 6 months, was lauded by the faculty trainees. It was considered the “most immediately relevant component” of this period of training. Because the trainees were experienced physicians when they began this project, they felt this part of training made the “…material more accessible to myself, more germane to what I do day in and day out.” The insight of modifying the interviewing techniques to connect with different patient personality types was particularly helpful. One trainee described an “aha moment” of “getting patients to open up in a way I had not been able to do before.” As time went on, the trainees felt empowered to adapt “the interviewing script” modestly to fit their already developed “rhythm and style with their patients.”
Wellness/Mentoring
The 2 trainees were at different stages of their careers, 1 early-career faculty and 1 mid-career faculty. This academic diversity within the small training group provided varied perspectives not only on the concepts presented and discussed, but also on a more personal level. In an otherwise hectic academic medicine environment, this group had a weekly chance to stop, “check in” with each other, and truly connect on a personal level. To be asked “about your week and actually mean it and want to hear the answer” is an unusual opportunity, one noted. It also offered time and support for purposeful self-reflection, which “often brought some emotions to the surface…at different times.” These connections were perhaps one of the most valuable parts of the experience. With burnout among physicians rampant,24 establishing these networks is invaluable. In addition to introspection and personal connections, there was a strong element of mentoring during these weekly meetings. The opportunity to meet in a small group with senior faculty was highly valued by the trainees.
Mental Health Care: Complex Patient Clinic
The faculty were eager, but very apprehensive, in beginning the second segment of training, where work shifted from lectures and practicing skills to mental health care training in the CPC. The trainees expressed anxiety about several areas. These included additional clinical workload, patient referral/selection, and transition of patient care back to the primary care provider. Of note, they did not particularly express worries about the care they would be providing, because a psychiatrist would be available to them on site. In reflection, after spending 4 months in the clinic, trainees noted “how important observing live interviews for evaluation/feedback was to their learning.” The CPC provided “learning in the moment on specific patients [which] was without question the most powerful teaching tool.” The support of the training faculty who were present at each clinic was invaluable. Whereas the earlier didactics given by psychiatrists were received by trainees with lukewarm enthusiasm, the point-of-care, case-by-case learning and feedback truly advanced the trainees’ knowledge, as well as skills, and improved their confidence in providing mental health care.
One of the tenets of the mental health care models is collaborative care.25 Recognizing this critical component of patient care, the CPC experience integrated a clinical social worker. The faculty noted the critical role she played in the patient care experience. They described her as “fabulous and awesome.” Her grasp of the health care system and community resources (particularly for an underserved population) was indispensable. Additionally, she was able to serve as a steady contact to follow patients through multiple visits and improve their feelings of continuity.
Teaching: Psychosocial Rotation
The first psychosocial teaching occurred after the interviewing skills and didactic experiences in the first 6 months. The trainees expressed great doubt about tackling this initial teaching experience. From residents challenging the need for interviewing and other aspects of “touchy-feely” teaching, to patients expressing raw emotions, the trainees lacked confidence in their ability to handle these moments. At this early stage of their training, one trainee said, “I feel like I am becoming a better interrogator, but I haven’t learned the skills to be a better healer yet.” Over time, this concern disappeared. As training evolved, the trainees began to thrive in their role as educator. At the final focus group, it was noted that “teaching has enhanced [my] confidence in the framework and in turn has made it easier to teach.”
Teaching: Complex Patient Clinic
This powerful teaching tool to train residents was the centerpiece of training. The faculty trainees had some hesitation about their role as teacher before it began. The faculty trainees were at different stages of their careers, and their confidence in their own teaching skills was not uniform. Importantly, the initial structure of the CPC, which included psychiatrists and senior faculty supervision, provided strong and continued support for the faculty trainees. Later work in the CPC as teacher, rather than trainee, further bolstered the faculty’s confidence in the treatment models. As confidence with their own skills grew, faculty noted that it became “easier to teach” as well. Faculty also recognized the unique opportunity that the CPC provided in directly observing a resident’s patient interaction. This allows them to “monitor progress, provide specific feedback, and address issues.” The time spent debriefing after each patient encounter was noted to be particularly important. When they became too busy to adequately provide this debriefing, changes to the schedule were made to accommodate it (follow-up visits were lengthened from 30 to 60 minutes). In addition to giving an opportunity to provide feedback, this extra time available for residents to interact with a patient—to utilize and practice the interviewing skills, for example—was quite valuable, independent of actual mental health care training. Finally, the faculty were able to create a “relaxed and comfortable” space in the CPC. Indeed, the faculty felt comfortable sharing some of their struggles and reflections on caring for a mental health patient population, and residents were able, in turn, to engage in some self-reflection and debriefing as well.
Discussion
Faculty trainees demonstrated a striking evolution as they progressed through this curriculum. At each of the 3 stages of training, they endorsed a broad range of feelings, from anxiety and uncertainty initially, to confidence and growth and appreciation later. They felt satisfied with having participated in the project and are engaged in exploring next steps.
Of note, these faculty members had some exposure to the skills models prior to starting the program because the residency program has integrated patient-centered interviewing into its program for many years. The faculty were supportive of the models prior to engaging in the curriculum, and they volunteered to participate. Similarly, the residents were familiar with the expectations as they went through the psychosocial rotation and the CPC. It is conceivable that the interviewing and mental health material may not be received as easily at an institution where the culture has had less exposure to such teaching.
While describing a faculty curriculum for mental health training is unique5 and the primary intent of this paper, we wanted to present its formative evaluation even though only 2 faculty trainees were involved. Simply put, the grant for this project supported only 2 trainees, and no more were required. Nevertheless, we propose that this only reported experience of medical faculty with mental health training is an important addition to the literature in mental health education. It will be a critical guide for others who choose the new direction of training medical faculty to teach mental health care.
As the research team looks to foster dissemination of the curriculum, it continues to be streamlined to highlight the components most useful and germane to learners. The early didactic readings on subjects such as general system theory were less engaging. (In later training of new medical faculty learners, the focus on theory and other didactics was reduced.) In contrast, the trainees clearly valued the interviewing skills experience (both learning and teaching). While the mental health curriculum and the CPC were associated with much greater anxiety in the trainees, with practical, respectful, and supervised teaching, they became confident and satisfied—as well as effective.6 Future teachers will benefit from slowly and understandingly addressing trainees’ personal issues, particularly during the initial phases of training.26 It appeared to us to be the key factor enabling the faculty to successfully learn and teach mental health care. Once they overcame their personal reactions to mental health material, they learned mental health skills just as they learn the more familiar physical disease material.
Conclusion
In a new direction in medical education, a curriculum for training medical faculty to teach mental health care is presented. Not only did prior research demonstrate that the faculty effectively trained residents, but we also demonstrated here that the training was acceptable to and valued by faculty. With mental health often an alien dimension of medicine, acceptability is especially important when we recommend disseminating the curriculum as a way to offset the national mental health care crisis.
Corresponding author: Robert C. Smith, 788 Service Road, B314 Clinical Center, East Lansing, MI 48824; smithrr@msu.edu.
Financial disclosures: None.
Funding support: The authors are grateful for the generous support from the Health Resources and Services Administration (D58HP23259).
1. Smith R, Gardiner J, Luo Z, et al. Primary care physicians treat somatization. J Gen Int Med. 2009;24:829-832.
2. Smith RC, Lyles JS, Gardiner JC, et al. Primary care clinicians treat patients with medically unexplained symptoms—a randomized controlled trial. J Gen Intern Med. 2006;21:671-677.
3. Smith RC, Lein C, Collins C, et al. Treating patients with medically unexplained symptoms in primary care. J Gen Intern Med. 2003;18:478-489.
4. Smith RC, Lyles JS, Mettler J, et al. The effectiveness of intensive training for residents in interviewing. A randomized, controlled study. Ann Intern Med. 1998;128:118-126.
5. Smith R, Laird-Fick H, D’Mello D, et al. Addressing mental health issues in primary care: an initial curriculum for medical residents. Patient Educ Couns. 2014;94:33-42.
6. Smith R, Laird-Fick H, Dwamena F, et al. Teaching residents mental health care. Patient Educ Couns. 2018;101:2145-2155.
7. Cunningham PJ. Beyond parity: primary care physicians’ perspectives on access to mental health care. Health Aff (Millwood). 2009;28:w490-501.
8. US Department of Health and Human Services: Healthy People 2020: The Road Ahead. Washington, DC: US Governmant Printing Office; 2011.
9. US Department of Health and Human Services. Facing Addiction in America—The Surgeon General’s Report on Alcohol, Drugs, and Health. Washington, DC: US Dept of Health and Human Services; 2016.
10. US Department of Health and Human Services. Mental Health and Mental Disorders. Washington, DC: US Government Printing Office; 2000.
11. Hogan MF. The President’s New Freedom Commission: recommendations to transform mental health care in America. Psychiatr Serv. 2003;54:1467-1474.
12. Morrisey J, Thomas K, Ellis A, et al. Development of a New Method for Designation of Mental Health Professional Shortage Areas. Chapel Hill, NC: University of North Carolina at Chapel Hill; 2007.
13. US Department of Health and Human Services. Mental Health: a Report of the Surgeon General. Rockville, MD: Dept. of Health and Human Services; 1999.
14. Wang PS, Lane M, Olfson M, et al. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:629-640.
15. Kern DE, Thomas PA, Hughes MT. Curriculum Development for Medical Education: A Six-Step Approach. Baltimore, MD: The Johns Hopkins University Press; 2009.
16. Fortin 6th AH, Dwamena F, Frankel R, et al. Smith’s Patient-Centered Interviewing: An Evidence-Based Method. 4th ed. New York, NY: McGraw-Hill; 2018.
17. Smith R, D’Mello D, Osborn G, et al. Essentials of Psychiatry in Primary Care: Behavioral Health in the Medical Setting. New York, NY: McGraw Hill; 2019 .
18. Smith R, Fortin AH 6th, Dwamena F, et al. An evidence-based patient-centered method makes the biopsychosocial model scientific. Patient Educ Couns. 2013;90:265-270.
19. Smith R, Dwamena F, Grover M, et al. Behaviorally-defined patient-centered communication—a narrative review of the literature. J Gen Intern Med. 2010;26:185-191.
20. Smith RC, Dwamena FC. Classification and diagnosis of patients with medically unexplained symptoms. J Gen Intern Med. 2007;22:685-691.
21. Schneider RK, Levenson JL. Psychiatry Essentials for Primary Care. Philadelphia, PA: American College of Physicians; 2008.
22. Dwamena F, Laird-Fick H, Freilich L, et al. Behavioral health problems in medical patients. J Clin Outcomes Manage. 2014;21:497-505.
23. Vidyo (Hackensack, NJ). http://www.vidyo.com/products/use/. 2014.
24. Panagioti M, Panagopoulou E, Bower P, et al. Controlled interventions to reduce burnout in physicians: a systematic review and meta-analysis. JAMA Intern Med. 2017;177:195-205.
25. Huffman JC, Niazi SK, Rundell JR, et al. Essential articles on collaborative care models for the treatment of psychiatric disorders in medical settings: a publication by the Academy of Psychosomatic Medicine Research and Evidence-Based Practice Committee. Psychosomatics. 2014;55:109-122.
26. Smith RC, Dwamena FC, Fortin AH 6th. Teaching personal awareness. J Gen Intern Med. 2005;20:201-207.
From Michigan State University, East Lansing, MI.
Abstract
- Objective: We previously reported that training medical faculty to teach mental health care to residents was effective. We here describe the faculty’s training curriculum and their responses to learning and teaching mental health care, a unique focus in the educational literature.
- Design: Qualitative researchers assessed the experiences of medical faculty trainees in learning and teaching mental health care.
- Setting: Internal medicine residency training program at Michigan State University.
- Participants: One early career medicine faculty learner and another faculty learner at mid-career, 4 faculty trainers, and 2 qualitative researchers.
- Measurements: Typed qualitative research reports were evaluated by the authors from 4 time periods: (1) following didactic and interviewing training; (2) following training in a mental health clinic; (3) following training to teach residents mental health care; and (4) 8 months after training.
- Results: Faculty expressed anxiety and low confidence at each of 3 levels of training, but progressively developed confidence and satisfaction during training at each level. They rated didactic experiences as least valuable, seeing these experiences as lacking practical application. Experiential training in interviewing and mental health care were positively viewed, as was the benefit from mentoring. Teaching mental health skills to residents was initially difficult, but faculty became comfortable with experience, which solidified the faculty’s confidence in their own skills.
- Conclusion: A new curriculum for training medical faculty to teach mental health care was demonstrated to be acceptable to the faculty, based on findings from multiple focus groups.
Keywords: psychiatry; primary care mental health; medical education; curriculum; formative evaluation.
We previously trained general medicine faculty intensively in 3 evidence-based models essential for mental health care.1-4 They, in turn, trained medical residents in the models over all 3 years of residency training.5 The results of this quasi-experimental trial demonstrated highly significant learning by residents on all 3 models.6 To address the mental health care crisis caused by the severe shortage of psychiatrists in the United States,7-14 we propose this train-the-trainer intervention as a model for widescale training of medical faculty in mental health care, thus enabling them to then train their own residents and students indefinitely.6
This brief report details the faculty training curriculum in mental health care and its teaching, along with the responses of medical faculty to the training; no similar training experiences have been reported in the medical or psychiatric literature. While the residency training curriculum has been published,5 the faculty training curriculum has not. Additionally, faculty responses to the training are important because they can provide key information about what did and did not work. Even though demonstrated to be effective for teaching mental health care to residents,6 the training must also be acceptable to its new teachers.15
Methods
Design, Setting, and Participants
This descriptive study was conducted by 2 experienced qualitative researchers in the setting of a 5-year quantitative study of residents’ learning of mental health care.5,6 They interviewed 2 general medicine faculty undergoing training in mental health care on 4 occasions: 3 times during training and once following training. Learners were taught by 4 faculty trainers (2 general medicine, 2 psychiatry). The setting was the internal medicine residency program at Michigan State University. The project was approved by the local Institutional Review Board.
Faculty Training Intervention
The 2 training faculty evaluated in this study were taught in a predominantly experiential way.5 Learning objectives were behaviorally defined (see Table 1, which also presents the teaching methods). Teaching occurred in 3 segments over 15 months, with a 10% weekly commitment to training supported by a research grant.
First 6 Months. For 1 half-day (4 hours) every week, teaching sessions were divided into 2 parts:
1. Experiential learning of the objectives, particularly patient-centered interviewing (Table 2)16 and mental health care models (Table 3).3,17 This initially involved role playing and was followed by using the models with hospital and clinic patients, sometimes directly observed, other times evaluated via audiotaped recordings.
2. Lecture and reading series, which occurred in 2 parts: (a) For the first 3 months, a biopsychosocial and patient-centered medicine seminar was guided by readings from a patient-centered interviewing textbook and 4 articles.3,16,18-20 These readings were supplemented by a large collection of material on our website that was utilized in a learner-centered fashion, depending on learners’ interests (these are available from the authors, along with a detailed outline we followed for each teaching session). (b) For the last 3 months, a psychiatry lecture series addressed the material needed for primary care mental health. The lectures were guided by a psychiatry textbook (the schedule and content of presentations is available from the authors).21
Beginning in the first 6 months, faculty also participated as co-teachers with their trainers in a long-standing psychosocial rotation, a 1-month full-time rotation for PGY-1 residents that occurred twice yearly during training. This initially helped them learn the models, and they later received experience in how to teach the models.
Middle 4 Months. During this period, faculty learners were supervised by trainers as they transitioned to learn mental health care in a Complex Patient Clinic (CPC). Training was guided by a syllabus now contained in a textbook.17 The CPC is a unique mental health care clinic located in the clinic area where faculty and residents observe other patients. Rooms resemble other exam rooms, except they have a computer attached to an audio-video camera that delivers the physician-patient interaction live to another room, where faculty observe it via a software program (Vidyo, Hackensack, NJ)22,23; no recordings are made of the live interactions. The details of patient recruitment and the CPC are described elsewhere.22 CPC patients had an average of 2.3 DSM-V diagnoses and 3.3 major medical diagnoses. Faculty trainees evaluated 2 or 3 patients each day.
Final 5 Months. Supervision continued for faculty learners as they taught mental health care to postgraduate year (PGY) 2 and 3 residents in the CPC. Residents had between 6 and 8 sessions in each of their last 2 years of training; 2 residents were assigned for each half-day CPC session and each evaluated 2 or 3 patients under faculty-learner supervision.
Data Collection
The qualitative interviewers were independent of the study. The research team members did not see the transcripts until preparing this report in conjunction with the interviewers. Data were collected from faculty at 4 points: following the initial 6 months of training in the models; following training in mental health care in the CPC; following supervision of faculty training of residents; and 8 months following completion of training, during which time they independently taught residents.
Data were collected in a systematic way over 1 hour, beginning and continuing open-endedly for about 30 minutes and concluding with closed-ended inquiry to pin down details and to ask any pre-planned questions that had not been answered. The protocol that guided focus group interviews is available from the authors.
Audio recordings were made from each group, and a 500- to 1000-word report was written by the interviewers, which served as the basis of the present descriptive evaluation. The authors independently analyzed the data at each collection point and then came to the consensus that follows.
Results
Lectures/Didactic Training
The training sessions involved 2 parts: lectures and didactic material around interviewing, general system theory, and psychiatry diagnoses; and skills practice in interviewing and the mental health care models. The trainers and faculty met weekly for 4 hours, and the first 2 hours of these sessions were spent reviewing the background of what would become the mainstay of the teaching, the models for interviewing and mental health care (Table 2 and Table 3). These readings differed in content and style from the typical clinical readings that physicians use, and they required considerable outside time and preparation, beyond that anticipated by the trainees. Digging into these theoretical concepts was described as interesting and “refreshing,” but the trainees at first found the readings disconnected from their clinical work. Faculty trainees later recognized the importance of understanding the models as they prepared for their roles as teachers. All told, however, the trainees believed there was too much didactic material.
Receiving education on diagnosis and management of common psychiatric disorders from academic psychiatrists was appreciated, but the trainees also expressed the greatest frustrations about this part of the curriculum. They felt that the level of these sessions was not always appropriately gauged—ranging from too simplistic, as in medical school, to too detailed, especially around neurochemical and neurobiological mechanisms. Although they appreciated learning about advanced psychiatric illness and treatments (eg, electroconvulsive treatment, especially), they did not believe the information was necessary in primary care. Trainees were experienced primary care providers and were more interested in case-based education that could highlight the types of patients seen in their office every day. One trainee indicated that these sessions were lacking “the patient voice.” Abstract discussion of diagnoses and treatments made it challenging to apply this new knowledge to the trainees’ practices. Trainees also suggested trying to integrate this section of the training with the interviewing skills training to better highlight that interplay. The trainees believed that their understanding and familiarity with the diagnosis and management of mental disorders occurred primarily in later CPC training. The trainees recommended that all didactic material be reduced by half or more in future teaching.
Skills Practice
The patient-centered interviewing skills practice, which occurred in the second 2-hour period during the first 6 months, was lauded by the faculty trainees. It was considered the “most immediately relevant component” of this period of training. Because the trainees were experienced physicians when they began this project, they felt this part of training made the “…material more accessible to myself, more germane to what I do day in and day out.” The insight of modifying the interviewing techniques to connect with different patient personality types was particularly helpful. One trainee described an “aha moment” of “getting patients to open up in a way I had not been able to do before.” As time went on, the trainees felt empowered to adapt “the interviewing script” modestly to fit their already developed “rhythm and style with their patients.”
Wellness/Mentoring
The 2 trainees were at different stages of their careers, 1 early-career faculty and 1 mid-career faculty. This academic diversity within the small training group provided varied perspectives not only on the concepts presented and discussed, but also on a more personal level. In an otherwise hectic academic medicine environment, this group had a weekly chance to stop, “check in” with each other, and truly connect on a personal level. To be asked “about your week and actually mean it and want to hear the answer” is an unusual opportunity, one noted. It also offered time and support for purposeful self-reflection, which “often brought some emotions to the surface…at different times.” These connections were perhaps one of the most valuable parts of the experience. With burnout among physicians rampant,24 establishing these networks is invaluable. In addition to introspection and personal connections, there was a strong element of mentoring during these weekly meetings. The opportunity to meet in a small group with senior faculty was highly valued by the trainees.
Mental Health Care: Complex Patient Clinic
The faculty were eager, but very apprehensive, in beginning the second segment of training, where work shifted from lectures and practicing skills to mental health care training in the CPC. The trainees expressed anxiety about several areas. These included additional clinical workload, patient referral/selection, and transition of patient care back to the primary care provider. Of note, they did not particularly express worries about the care they would be providing, because a psychiatrist would be available to them on site. In reflection, after spending 4 months in the clinic, trainees noted “how important observing live interviews for evaluation/feedback was to their learning.” The CPC provided “learning in the moment on specific patients [which] was without question the most powerful teaching tool.” The support of the training faculty who were present at each clinic was invaluable. Whereas the earlier didactics given by psychiatrists were received by trainees with lukewarm enthusiasm, the point-of-care, case-by-case learning and feedback truly advanced the trainees’ knowledge, as well as skills, and improved their confidence in providing mental health care.
One of the tenets of the mental health care models is collaborative care.25 Recognizing this critical component of patient care, the CPC experience integrated a clinical social worker. The faculty noted the critical role she played in the patient care experience. They described her as “fabulous and awesome.” Her grasp of the health care system and community resources (particularly for an underserved population) was indispensable. Additionally, she was able to serve as a steady contact to follow patients through multiple visits and improve their feelings of continuity.
Teaching: Psychosocial Rotation
The first psychosocial teaching occurred after the interviewing skills and didactic experiences in the first 6 months. The trainees expressed great doubt about tackling this initial teaching experience. From residents challenging the need for interviewing and other aspects of “touchy-feely” teaching, to patients expressing raw emotions, the trainees lacked confidence in their ability to handle these moments. At this early stage of their training, one trainee said, “I feel like I am becoming a better interrogator, but I haven’t learned the skills to be a better healer yet.” Over time, this concern disappeared. As training evolved, the trainees began to thrive in their role as educator. At the final focus group, it was noted that “teaching has enhanced [my] confidence in the framework and in turn has made it easier to teach.”
Teaching: Complex Patient Clinic
This powerful teaching tool to train residents was the centerpiece of training. The faculty trainees had some hesitation about their role as teacher before it began. The faculty trainees were at different stages of their careers, and their confidence in their own teaching skills was not uniform. Importantly, the initial structure of the CPC, which included psychiatrists and senior faculty supervision, provided strong and continued support for the faculty trainees. Later work in the CPC as teacher, rather than trainee, further bolstered the faculty’s confidence in the treatment models. As confidence with their own skills grew, faculty noted that it became “easier to teach” as well. Faculty also recognized the unique opportunity that the CPC provided in directly observing a resident’s patient interaction. This allows them to “monitor progress, provide specific feedback, and address issues.” The time spent debriefing after each patient encounter was noted to be particularly important. When they became too busy to adequately provide this debriefing, changes to the schedule were made to accommodate it (follow-up visits were lengthened from 30 to 60 minutes). In addition to giving an opportunity to provide feedback, this extra time available for residents to interact with a patient—to utilize and practice the interviewing skills, for example—was quite valuable, independent of actual mental health care training. Finally, the faculty were able to create a “relaxed and comfortable” space in the CPC. Indeed, the faculty felt comfortable sharing some of their struggles and reflections on caring for a mental health patient population, and residents were able, in turn, to engage in some self-reflection and debriefing as well.
Discussion
Faculty trainees demonstrated a striking evolution as they progressed through this curriculum. At each of the 3 stages of training, they endorsed a broad range of feelings, from anxiety and uncertainty initially, to confidence and growth and appreciation later. They felt satisfied with having participated in the project and are engaged in exploring next steps.
Of note, these faculty members had some exposure to the skills models prior to starting the program because the residency program has integrated patient-centered interviewing into its program for many years. The faculty were supportive of the models prior to engaging in the curriculum, and they volunteered to participate. Similarly, the residents were familiar with the expectations as they went through the psychosocial rotation and the CPC. It is conceivable that the interviewing and mental health material may not be received as easily at an institution where the culture has had less exposure to such teaching.
While describing a faculty curriculum for mental health training is unique5 and the primary intent of this paper, we wanted to present its formative evaluation even though only 2 faculty trainees were involved. Simply put, the grant for this project supported only 2 trainees, and no more were required. Nevertheless, we propose that this only reported experience of medical faculty with mental health training is an important addition to the literature in mental health education. It will be a critical guide for others who choose the new direction of training medical faculty to teach mental health care.
As the research team looks to foster dissemination of the curriculum, it continues to be streamlined to highlight the components most useful and germane to learners. The early didactic readings on subjects such as general system theory were less engaging. (In later training of new medical faculty learners, the focus on theory and other didactics was reduced.) In contrast, the trainees clearly valued the interviewing skills experience (both learning and teaching). While the mental health curriculum and the CPC were associated with much greater anxiety in the trainees, with practical, respectful, and supervised teaching, they became confident and satisfied—as well as effective.6 Future teachers will benefit from slowly and understandingly addressing trainees’ personal issues, particularly during the initial phases of training.26 It appeared to us to be the key factor enabling the faculty to successfully learn and teach mental health care. Once they overcame their personal reactions to mental health material, they learned mental health skills just as they learn the more familiar physical disease material.
Conclusion
In a new direction in medical education, a curriculum for training medical faculty to teach mental health care is presented. Not only did prior research demonstrate that the faculty effectively trained residents, but we also demonstrated here that the training was acceptable to and valued by faculty. With mental health often an alien dimension of medicine, acceptability is especially important when we recommend disseminating the curriculum as a way to offset the national mental health care crisis.
Corresponding author: Robert C. Smith, 788 Service Road, B314 Clinical Center, East Lansing, MI 48824; smithrr@msu.edu.
Financial disclosures: None.
Funding support: The authors are grateful for the generous support from the Health Resources and Services Administration (D58HP23259).
From Michigan State University, East Lansing, MI.
Abstract
- Objective: We previously reported that training medical faculty to teach mental health care to residents was effective. We here describe the faculty’s training curriculum and their responses to learning and teaching mental health care, a unique focus in the educational literature.
- Design: Qualitative researchers assessed the experiences of medical faculty trainees in learning and teaching mental health care.
- Setting: Internal medicine residency training program at Michigan State University.
- Participants: One early career medicine faculty learner and another faculty learner at mid-career, 4 faculty trainers, and 2 qualitative researchers.
- Measurements: Typed qualitative research reports were evaluated by the authors from 4 time periods: (1) following didactic and interviewing training; (2) following training in a mental health clinic; (3) following training to teach residents mental health care; and (4) 8 months after training.
- Results: Faculty expressed anxiety and low confidence at each of 3 levels of training, but progressively developed confidence and satisfaction during training at each level. They rated didactic experiences as least valuable, seeing these experiences as lacking practical application. Experiential training in interviewing and mental health care were positively viewed, as was the benefit from mentoring. Teaching mental health skills to residents was initially difficult, but faculty became comfortable with experience, which solidified the faculty’s confidence in their own skills.
- Conclusion: A new curriculum for training medical faculty to teach mental health care was demonstrated to be acceptable to the faculty, based on findings from multiple focus groups.
Keywords: psychiatry; primary care mental health; medical education; curriculum; formative evaluation.
We previously trained general medicine faculty intensively in 3 evidence-based models essential for mental health care.1-4 They, in turn, trained medical residents in the models over all 3 years of residency training.5 The results of this quasi-experimental trial demonstrated highly significant learning by residents on all 3 models.6 To address the mental health care crisis caused by the severe shortage of psychiatrists in the United States,7-14 we propose this train-the-trainer intervention as a model for widescale training of medical faculty in mental health care, thus enabling them to then train their own residents and students indefinitely.6
This brief report details the faculty training curriculum in mental health care and its teaching, along with the responses of medical faculty to the training; no similar training experiences have been reported in the medical or psychiatric literature. While the residency training curriculum has been published,5 the faculty training curriculum has not. Additionally, faculty responses to the training are important because they can provide key information about what did and did not work. Even though demonstrated to be effective for teaching mental health care to residents,6 the training must also be acceptable to its new teachers.15
Methods
Design, Setting, and Participants
This descriptive study was conducted by 2 experienced qualitative researchers in the setting of a 5-year quantitative study of residents’ learning of mental health care.5,6 They interviewed 2 general medicine faculty undergoing training in mental health care on 4 occasions: 3 times during training and once following training. Learners were taught by 4 faculty trainers (2 general medicine, 2 psychiatry). The setting was the internal medicine residency program at Michigan State University. The project was approved by the local Institutional Review Board.
Faculty Training Intervention
The 2 training faculty evaluated in this study were taught in a predominantly experiential way.5 Learning objectives were behaviorally defined (see Table 1, which also presents the teaching methods). Teaching occurred in 3 segments over 15 months, with a 10% weekly commitment to training supported by a research grant.
First 6 Months. For 1 half-day (4 hours) every week, teaching sessions were divided into 2 parts:
1. Experiential learning of the objectives, particularly patient-centered interviewing (Table 2)16 and mental health care models (Table 3).3,17 This initially involved role playing and was followed by using the models with hospital and clinic patients, sometimes directly observed, other times evaluated via audiotaped recordings.
2. Lecture and reading series, which occurred in 2 parts: (a) For the first 3 months, a biopsychosocial and patient-centered medicine seminar was guided by readings from a patient-centered interviewing textbook and 4 articles.3,16,18-20 These readings were supplemented by a large collection of material on our website that was utilized in a learner-centered fashion, depending on learners’ interests (these are available from the authors, along with a detailed outline we followed for each teaching session). (b) For the last 3 months, a psychiatry lecture series addressed the material needed for primary care mental health. The lectures were guided by a psychiatry textbook (the schedule and content of presentations is available from the authors).21
Beginning in the first 6 months, faculty also participated as co-teachers with their trainers in a long-standing psychosocial rotation, a 1-month full-time rotation for PGY-1 residents that occurred twice yearly during training. This initially helped them learn the models, and they later received experience in how to teach the models.
Middle 4 Months. During this period, faculty learners were supervised by trainers as they transitioned to learn mental health care in a Complex Patient Clinic (CPC). Training was guided by a syllabus now contained in a textbook.17 The CPC is a unique mental health care clinic located in the clinic area where faculty and residents observe other patients. Rooms resemble other exam rooms, except they have a computer attached to an audio-video camera that delivers the physician-patient interaction live to another room, where faculty observe it via a software program (Vidyo, Hackensack, NJ)22,23; no recordings are made of the live interactions. The details of patient recruitment and the CPC are described elsewhere.22 CPC patients had an average of 2.3 DSM-V diagnoses and 3.3 major medical diagnoses. Faculty trainees evaluated 2 or 3 patients each day.
Final 5 Months. Supervision continued for faculty learners as they taught mental health care to postgraduate year (PGY) 2 and 3 residents in the CPC. Residents had between 6 and 8 sessions in each of their last 2 years of training; 2 residents were assigned for each half-day CPC session and each evaluated 2 or 3 patients under faculty-learner supervision.
Data Collection
The qualitative interviewers were independent of the study. The research team members did not see the transcripts until preparing this report in conjunction with the interviewers. Data were collected from faculty at 4 points: following the initial 6 months of training in the models; following training in mental health care in the CPC; following supervision of faculty training of residents; and 8 months following completion of training, during which time they independently taught residents.
Data were collected in a systematic way over 1 hour, beginning and continuing open-endedly for about 30 minutes and concluding with closed-ended inquiry to pin down details and to ask any pre-planned questions that had not been answered. The protocol that guided focus group interviews is available from the authors.
Audio recordings were made from each group, and a 500- to 1000-word report was written by the interviewers, which served as the basis of the present descriptive evaluation. The authors independently analyzed the data at each collection point and then came to the consensus that follows.
Results
Lectures/Didactic Training
The training sessions involved 2 parts: lectures and didactic material around interviewing, general system theory, and psychiatry diagnoses; and skills practice in interviewing and the mental health care models. The trainers and faculty met weekly for 4 hours, and the first 2 hours of these sessions were spent reviewing the background of what would become the mainstay of the teaching, the models for interviewing and mental health care (Table 2 and Table 3). These readings differed in content and style from the typical clinical readings that physicians use, and they required considerable outside time and preparation, beyond that anticipated by the trainees. Digging into these theoretical concepts was described as interesting and “refreshing,” but the trainees at first found the readings disconnected from their clinical work. Faculty trainees later recognized the importance of understanding the models as they prepared for their roles as teachers. All told, however, the trainees believed there was too much didactic material.
Receiving education on diagnosis and management of common psychiatric disorders from academic psychiatrists was appreciated, but the trainees also expressed the greatest frustrations about this part of the curriculum. They felt that the level of these sessions was not always appropriately gauged—ranging from too simplistic, as in medical school, to too detailed, especially around neurochemical and neurobiological mechanisms. Although they appreciated learning about advanced psychiatric illness and treatments (eg, electroconvulsive treatment, especially), they did not believe the information was necessary in primary care. Trainees were experienced primary care providers and were more interested in case-based education that could highlight the types of patients seen in their office every day. One trainee indicated that these sessions were lacking “the patient voice.” Abstract discussion of diagnoses and treatments made it challenging to apply this new knowledge to the trainees’ practices. Trainees also suggested trying to integrate this section of the training with the interviewing skills training to better highlight that interplay. The trainees believed that their understanding and familiarity with the diagnosis and management of mental disorders occurred primarily in later CPC training. The trainees recommended that all didactic material be reduced by half or more in future teaching.
Skills Practice
The patient-centered interviewing skills practice, which occurred in the second 2-hour period during the first 6 months, was lauded by the faculty trainees. It was considered the “most immediately relevant component” of this period of training. Because the trainees were experienced physicians when they began this project, they felt this part of training made the “…material more accessible to myself, more germane to what I do day in and day out.” The insight of modifying the interviewing techniques to connect with different patient personality types was particularly helpful. One trainee described an “aha moment” of “getting patients to open up in a way I had not been able to do before.” As time went on, the trainees felt empowered to adapt “the interviewing script” modestly to fit their already developed “rhythm and style with their patients.”
Wellness/Mentoring
The 2 trainees were at different stages of their careers, 1 early-career faculty and 1 mid-career faculty. This academic diversity within the small training group provided varied perspectives not only on the concepts presented and discussed, but also on a more personal level. In an otherwise hectic academic medicine environment, this group had a weekly chance to stop, “check in” with each other, and truly connect on a personal level. To be asked “about your week and actually mean it and want to hear the answer” is an unusual opportunity, one noted. It also offered time and support for purposeful self-reflection, which “often brought some emotions to the surface…at different times.” These connections were perhaps one of the most valuable parts of the experience. With burnout among physicians rampant,24 establishing these networks is invaluable. In addition to introspection and personal connections, there was a strong element of mentoring during these weekly meetings. The opportunity to meet in a small group with senior faculty was highly valued by the trainees.
Mental Health Care: Complex Patient Clinic
The faculty were eager, but very apprehensive, in beginning the second segment of training, where work shifted from lectures and practicing skills to mental health care training in the CPC. The trainees expressed anxiety about several areas. These included additional clinical workload, patient referral/selection, and transition of patient care back to the primary care provider. Of note, they did not particularly express worries about the care they would be providing, because a psychiatrist would be available to them on site. In reflection, after spending 4 months in the clinic, trainees noted “how important observing live interviews for evaluation/feedback was to their learning.” The CPC provided “learning in the moment on specific patients [which] was without question the most powerful teaching tool.” The support of the training faculty who were present at each clinic was invaluable. Whereas the earlier didactics given by psychiatrists were received by trainees with lukewarm enthusiasm, the point-of-care, case-by-case learning and feedback truly advanced the trainees’ knowledge, as well as skills, and improved their confidence in providing mental health care.
One of the tenets of the mental health care models is collaborative care.25 Recognizing this critical component of patient care, the CPC experience integrated a clinical social worker. The faculty noted the critical role she played in the patient care experience. They described her as “fabulous and awesome.” Her grasp of the health care system and community resources (particularly for an underserved population) was indispensable. Additionally, she was able to serve as a steady contact to follow patients through multiple visits and improve their feelings of continuity.
Teaching: Psychosocial Rotation
The first psychosocial teaching occurred after the interviewing skills and didactic experiences in the first 6 months. The trainees expressed great doubt about tackling this initial teaching experience. From residents challenging the need for interviewing and other aspects of “touchy-feely” teaching, to patients expressing raw emotions, the trainees lacked confidence in their ability to handle these moments. At this early stage of their training, one trainee said, “I feel like I am becoming a better interrogator, but I haven’t learned the skills to be a better healer yet.” Over time, this concern disappeared. As training evolved, the trainees began to thrive in their role as educator. At the final focus group, it was noted that “teaching has enhanced [my] confidence in the framework and in turn has made it easier to teach.”
Teaching: Complex Patient Clinic
This powerful teaching tool to train residents was the centerpiece of training. The faculty trainees had some hesitation about their role as teacher before it began. The faculty trainees were at different stages of their careers, and their confidence in their own teaching skills was not uniform. Importantly, the initial structure of the CPC, which included psychiatrists and senior faculty supervision, provided strong and continued support for the faculty trainees. Later work in the CPC as teacher, rather than trainee, further bolstered the faculty’s confidence in the treatment models. As confidence with their own skills grew, faculty noted that it became “easier to teach” as well. Faculty also recognized the unique opportunity that the CPC provided in directly observing a resident’s patient interaction. This allows them to “monitor progress, provide specific feedback, and address issues.” The time spent debriefing after each patient encounter was noted to be particularly important. When they became too busy to adequately provide this debriefing, changes to the schedule were made to accommodate it (follow-up visits were lengthened from 30 to 60 minutes). In addition to giving an opportunity to provide feedback, this extra time available for residents to interact with a patient—to utilize and practice the interviewing skills, for example—was quite valuable, independent of actual mental health care training. Finally, the faculty were able to create a “relaxed and comfortable” space in the CPC. Indeed, the faculty felt comfortable sharing some of their struggles and reflections on caring for a mental health patient population, and residents were able, in turn, to engage in some self-reflection and debriefing as well.
Discussion
Faculty trainees demonstrated a striking evolution as they progressed through this curriculum. At each of the 3 stages of training, they endorsed a broad range of feelings, from anxiety and uncertainty initially, to confidence and growth and appreciation later. They felt satisfied with having participated in the project and are engaged in exploring next steps.
Of note, these faculty members had some exposure to the skills models prior to starting the program because the residency program has integrated patient-centered interviewing into its program for many years. The faculty were supportive of the models prior to engaging in the curriculum, and they volunteered to participate. Similarly, the residents were familiar with the expectations as they went through the psychosocial rotation and the CPC. It is conceivable that the interviewing and mental health material may not be received as easily at an institution where the culture has had less exposure to such teaching.
While describing a faculty curriculum for mental health training is unique5 and the primary intent of this paper, we wanted to present its formative evaluation even though only 2 faculty trainees were involved. Simply put, the grant for this project supported only 2 trainees, and no more were required. Nevertheless, we propose that this only reported experience of medical faculty with mental health training is an important addition to the literature in mental health education. It will be a critical guide for others who choose the new direction of training medical faculty to teach mental health care.
As the research team looks to foster dissemination of the curriculum, it continues to be streamlined to highlight the components most useful and germane to learners. The early didactic readings on subjects such as general system theory were less engaging. (In later training of new medical faculty learners, the focus on theory and other didactics was reduced.) In contrast, the trainees clearly valued the interviewing skills experience (both learning and teaching). While the mental health curriculum and the CPC were associated with much greater anxiety in the trainees, with practical, respectful, and supervised teaching, they became confident and satisfied—as well as effective.6 Future teachers will benefit from slowly and understandingly addressing trainees’ personal issues, particularly during the initial phases of training.26 It appeared to us to be the key factor enabling the faculty to successfully learn and teach mental health care. Once they overcame their personal reactions to mental health material, they learned mental health skills just as they learn the more familiar physical disease material.
Conclusion
In a new direction in medical education, a curriculum for training medical faculty to teach mental health care is presented. Not only did prior research demonstrate that the faculty effectively trained residents, but we also demonstrated here that the training was acceptable to and valued by faculty. With mental health often an alien dimension of medicine, acceptability is especially important when we recommend disseminating the curriculum as a way to offset the national mental health care crisis.
Corresponding author: Robert C. Smith, 788 Service Road, B314 Clinical Center, East Lansing, MI 48824; smithrr@msu.edu.
Financial disclosures: None.
Funding support: The authors are grateful for the generous support from the Health Resources and Services Administration (D58HP23259).
1. Smith R, Gardiner J, Luo Z, et al. Primary care physicians treat somatization. J Gen Int Med. 2009;24:829-832.
2. Smith RC, Lyles JS, Gardiner JC, et al. Primary care clinicians treat patients with medically unexplained symptoms—a randomized controlled trial. J Gen Intern Med. 2006;21:671-677.
3. Smith RC, Lein C, Collins C, et al. Treating patients with medically unexplained symptoms in primary care. J Gen Intern Med. 2003;18:478-489.
4. Smith RC, Lyles JS, Mettler J, et al. The effectiveness of intensive training for residents in interviewing. A randomized, controlled study. Ann Intern Med. 1998;128:118-126.
5. Smith R, Laird-Fick H, D’Mello D, et al. Addressing mental health issues in primary care: an initial curriculum for medical residents. Patient Educ Couns. 2014;94:33-42.
6. Smith R, Laird-Fick H, Dwamena F, et al. Teaching residents mental health care. Patient Educ Couns. 2018;101:2145-2155.
7. Cunningham PJ. Beyond parity: primary care physicians’ perspectives on access to mental health care. Health Aff (Millwood). 2009;28:w490-501.
8. US Department of Health and Human Services: Healthy People 2020: The Road Ahead. Washington, DC: US Governmant Printing Office; 2011.
9. US Department of Health and Human Services. Facing Addiction in America—The Surgeon General’s Report on Alcohol, Drugs, and Health. Washington, DC: US Dept of Health and Human Services; 2016.
10. US Department of Health and Human Services. Mental Health and Mental Disorders. Washington, DC: US Government Printing Office; 2000.
11. Hogan MF. The President’s New Freedom Commission: recommendations to transform mental health care in America. Psychiatr Serv. 2003;54:1467-1474.
12. Morrisey J, Thomas K, Ellis A, et al. Development of a New Method for Designation of Mental Health Professional Shortage Areas. Chapel Hill, NC: University of North Carolina at Chapel Hill; 2007.
13. US Department of Health and Human Services. Mental Health: a Report of the Surgeon General. Rockville, MD: Dept. of Health and Human Services; 1999.
14. Wang PS, Lane M, Olfson M, et al. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:629-640.
15. Kern DE, Thomas PA, Hughes MT. Curriculum Development for Medical Education: A Six-Step Approach. Baltimore, MD: The Johns Hopkins University Press; 2009.
16. Fortin 6th AH, Dwamena F, Frankel R, et al. Smith’s Patient-Centered Interviewing: An Evidence-Based Method. 4th ed. New York, NY: McGraw-Hill; 2018.
17. Smith R, D’Mello D, Osborn G, et al. Essentials of Psychiatry in Primary Care: Behavioral Health in the Medical Setting. New York, NY: McGraw Hill; 2019 .
18. Smith R, Fortin AH 6th, Dwamena F, et al. An evidence-based patient-centered method makes the biopsychosocial model scientific. Patient Educ Couns. 2013;90:265-270.
19. Smith R, Dwamena F, Grover M, et al. Behaviorally-defined patient-centered communication—a narrative review of the literature. J Gen Intern Med. 2010;26:185-191.
20. Smith RC, Dwamena FC. Classification and diagnosis of patients with medically unexplained symptoms. J Gen Intern Med. 2007;22:685-691.
21. Schneider RK, Levenson JL. Psychiatry Essentials for Primary Care. Philadelphia, PA: American College of Physicians; 2008.
22. Dwamena F, Laird-Fick H, Freilich L, et al. Behavioral health problems in medical patients. J Clin Outcomes Manage. 2014;21:497-505.
23. Vidyo (Hackensack, NJ). http://www.vidyo.com/products/use/. 2014.
24. Panagioti M, Panagopoulou E, Bower P, et al. Controlled interventions to reduce burnout in physicians: a systematic review and meta-analysis. JAMA Intern Med. 2017;177:195-205.
25. Huffman JC, Niazi SK, Rundell JR, et al. Essential articles on collaborative care models for the treatment of psychiatric disorders in medical settings: a publication by the Academy of Psychosomatic Medicine Research and Evidence-Based Practice Committee. Psychosomatics. 2014;55:109-122.
26. Smith RC, Dwamena FC, Fortin AH 6th. Teaching personal awareness. J Gen Intern Med. 2005;20:201-207.
1. Smith R, Gardiner J, Luo Z, et al. Primary care physicians treat somatization. J Gen Int Med. 2009;24:829-832.
2. Smith RC, Lyles JS, Gardiner JC, et al. Primary care clinicians treat patients with medically unexplained symptoms—a randomized controlled trial. J Gen Intern Med. 2006;21:671-677.
3. Smith RC, Lein C, Collins C, et al. Treating patients with medically unexplained symptoms in primary care. J Gen Intern Med. 2003;18:478-489.
4. Smith RC, Lyles JS, Mettler J, et al. The effectiveness of intensive training for residents in interviewing. A randomized, controlled study. Ann Intern Med. 1998;128:118-126.
5. Smith R, Laird-Fick H, D’Mello D, et al. Addressing mental health issues in primary care: an initial curriculum for medical residents. Patient Educ Couns. 2014;94:33-42.
6. Smith R, Laird-Fick H, Dwamena F, et al. Teaching residents mental health care. Patient Educ Couns. 2018;101:2145-2155.
7. Cunningham PJ. Beyond parity: primary care physicians’ perspectives on access to mental health care. Health Aff (Millwood). 2009;28:w490-501.
8. US Department of Health and Human Services: Healthy People 2020: The Road Ahead. Washington, DC: US Governmant Printing Office; 2011.
9. US Department of Health and Human Services. Facing Addiction in America—The Surgeon General’s Report on Alcohol, Drugs, and Health. Washington, DC: US Dept of Health and Human Services; 2016.
10. US Department of Health and Human Services. Mental Health and Mental Disorders. Washington, DC: US Government Printing Office; 2000.
11. Hogan MF. The President’s New Freedom Commission: recommendations to transform mental health care in America. Psychiatr Serv. 2003;54:1467-1474.
12. Morrisey J, Thomas K, Ellis A, et al. Development of a New Method for Designation of Mental Health Professional Shortage Areas. Chapel Hill, NC: University of North Carolina at Chapel Hill; 2007.
13. US Department of Health and Human Services. Mental Health: a Report of the Surgeon General. Rockville, MD: Dept. of Health and Human Services; 1999.
14. Wang PS, Lane M, Olfson M, et al. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:629-640.
15. Kern DE, Thomas PA, Hughes MT. Curriculum Development for Medical Education: A Six-Step Approach. Baltimore, MD: The Johns Hopkins University Press; 2009.
16. Fortin 6th AH, Dwamena F, Frankel R, et al. Smith’s Patient-Centered Interviewing: An Evidence-Based Method. 4th ed. New York, NY: McGraw-Hill; 2018.
17. Smith R, D’Mello D, Osborn G, et al. Essentials of Psychiatry in Primary Care: Behavioral Health in the Medical Setting. New York, NY: McGraw Hill; 2019 .
18. Smith R, Fortin AH 6th, Dwamena F, et al. An evidence-based patient-centered method makes the biopsychosocial model scientific. Patient Educ Couns. 2013;90:265-270.
19. Smith R, Dwamena F, Grover M, et al. Behaviorally-defined patient-centered communication—a narrative review of the literature. J Gen Intern Med. 2010;26:185-191.
20. Smith RC, Dwamena FC. Classification and diagnosis of patients with medically unexplained symptoms. J Gen Intern Med. 2007;22:685-691.
21. Schneider RK, Levenson JL. Psychiatry Essentials for Primary Care. Philadelphia, PA: American College of Physicians; 2008.
22. Dwamena F, Laird-Fick H, Freilich L, et al. Behavioral health problems in medical patients. J Clin Outcomes Manage. 2014;21:497-505.
23. Vidyo (Hackensack, NJ). http://www.vidyo.com/products/use/. 2014.
24. Panagioti M, Panagopoulou E, Bower P, et al. Controlled interventions to reduce burnout in physicians: a systematic review and meta-analysis. JAMA Intern Med. 2017;177:195-205.
25. Huffman JC, Niazi SK, Rundell JR, et al. Essential articles on collaborative care models for the treatment of psychiatric disorders in medical settings: a publication by the Academy of Psychosomatic Medicine Research and Evidence-Based Practice Committee. Psychosomatics. 2014;55:109-122.
26. Smith RC, Dwamena FC, Fortin AH 6th. Teaching personal awareness. J Gen Intern Med. 2005;20:201-207.