The safety and the efficacy of shorter durations of antibiotic therapy for uncomplicated pneumonia have been clearly established in the past decade.^1,2 Guidelines from the Infectious Diseases Society of America (IDSA) and the American Thoracic Society have been available since 2007. These expert consensus statements recommend that uncomplicated community-acquired pneumonia (CAP) should be treated for 5 to 7 days, as long as the patient exhibits signs and symptoms of clinical stability.³ Similarly, recently updated guidelines for hospital-acquired and ventilator-associated pneumonias call for short-course therapy.⁴ Despite this guidance, pneumonia treatment duration is often discordant.⁵ Unnecessary antimicrobial use is associated with greater selection pressure on pathogens, increased risk of adverse events (AEs), and elevated treatment costs.⁶ The growing burden of antibiotic resistance coupled with limited availability of new antibiotics requires judicious use of these agents.

The IDSA guidelines for Clostridium difficile infection (CDI) note that exposure to antimicrobial agents is the most important modifiable risk factor for the development of CDI.⁷ Longer durations of antibiotics increase the risk of CDI compared with shorter durations.^8,9 Antibiotics are a frequent cause of drug-associated AEs and likely are underestimated.¹⁰ To decrease the unwanted effects of excessive therapy, IDSA and CDC suggest that antimicrobial stewardship interventions should be implemented.^11-13

Antimicrobial stewardship efforts in small community hospitals (also known as district, rural, general, and primary hospitals) are varied and can be challenging due to limited staff and resources.^14,15 The World Health Organization defines a primary care facility as having few specialties, mainly internal medicine and general surgery with limited laboratory services for general (but not specialized) pathologic analysis, and bed size ranging from 30 to 200 beds.¹⁶ Although guidance is available for effective intervention strategies in smaller hospitals, there are limited data in the literature regarding successful outcomes.^17-22

The purpose of this study was to establish the need and evaluate the impact of a pharmacy-initiated 3-part intervention targeting treatment duration in patients hospitalized with uncomplicated pneumonia in a primary hospital setting. The Veterans Health Care System of the Ozarks (VHSO) in Fayetteville, Arkansas, has 50 acute care beds, including 7 intensive care unit beds and excluding 15 mental health beds. The pharmacy is staffed 24 hours a day. Acute-care providers consist of 7 full-time hospitalists, not including nocturnists and contract physicians. The VHSO does not have an infectious disease physician on staff.

The antimicrobial stewardship committee consists of 3 clinical pharmacists, a pulmonologist, a pathologist, and 2 infection-control nurses. There is 1 full-time equivalent allotted for inpatient clinical pharmacy activities in the acute care areas, including enforcement of all antimicrobial stewardship policies, which are conducted by a single pharmacist.

Methods

This was a retrospective chart review of two 12-month periods using a before and after study design. Medical records were reviewed during October 2012 through September 2013 (before the stewardship implementation) and December 2014 through November 2015 (after implementation). Inclusion criteria consisted of a primary discharge diagnosis of pneumonia as documented by the provider (or secondary diagnosis if sepsis was primary), hospitalization for at least 48 hours, administration of antibiotics for a minimum of 24 hours, and survival to discharge.

Exclusion criteria consisted of direct transfer from another facility, inappropriate empiric therapy as evidenced by culture data (isolated pathogens not covered by prescribed antibiotics), pneumonia that developed 48 hours after admission, extrapulmonary sources of infection, hospitalization > 14 days, discharge without a known duration of outpatient antibiotics, discharge for pneumonia within 28 days prior to admission, documented infection caused by Pseudomonas aeruginosa or other nonlactose fermenting Gram-negative rod, and complicated pneumonias defined as lung abscess, empyema, or severe immunosuppression (eg, cancer with chemotherapy within the previous 30 days, transplant recipients, HIV infection, acquired or congenital immunodeficiency, or absolute neutrophil count 1,500 cell/mm³ within past 28 days).

Patients were designated with health care-associated pneumonia (HCAP) if they were hospitalized ≥ 2 days or resided in a skilled nursing or extended-care facility within the previous 90 days; on chronic dialysis; or had wound care, tracheostomy care, or ventilator care from a health care professional within the previous 28 days. Criteria for clinical stability were defined as ≤ 100.4º F temperature, ≤ 100 beats/min heart rate, ≤ 24 breaths/min respiratory rate, ≥ 90 mm Hg systolic blood pressure, ≥ 90% or PaO₂ ≥ 60 mm Hg oxygen saturation on room air (or baseline oxygen requirements), and return to baseline mental status. To compare groups, researchers tabulated the pneumonia severity index on hospital day 1.

The intervention consisted of a 3-part process. First, hospitalists were educated on VHSO’s baseline treatment duration data, and these were compared with current IDSA recommendations. The education was followed by an open-discussion component to solicit feedback from providers on perceived barriers to following guidelines. Provider feedback was used to tailor an antimicrobial stewardship intervention to address perceived barriers to optimal antibiotic treatment duration.

After the education component, prospective intervention and feedback were provided for hospitalized patients by a single clinical pharmacist. This pharmacist interacted verbally and in writing with the patients’ providers, discussing antimicrobial appropriateness, de-escalation, duration of therapy, and intravenous to oral switching. Finally, a stewardship note for the Computerized Patient Record System (CPRS) was generated and included a template with reminders of clinical stability, duration of current therapy, and a request to discontinue therapy if the patient met criteria. For patients who remained hospitalized, this note was entered into CPRS on or about day 7 of antibiotic therapy; this required an electronic signature from the provider.

The VHSO Pharmacy and Therapeutics Committee approved both the provider education and the stewardship note in November 2014, and implementation of the stewardship intervention occurred immediately afterward. The pharmacy staff also was educated on the VHSO baseline data and stewardship efforts.

The primary outcome of the study was the change in days of total antibiotic treatment. Secondary outcomes included days of intravenous antibiotic therapy, days of inpatient oral therapy, mean length of stay (LOS), and number of outpatient antibiotic days once discharged. Incidence of CDI and 28-day readmissions were also evaluated. The VHSO Institutional Review Board approved these methods and the procedures that followed were in accord with the ethical standards of the VHSO Committee on Human Experimentation.

Statistical Analysis

All continuous variables are reported as mean ± standard deviation. Data analysis for significance was performed using a Student t test for continuous variables and a χ² test (or Fisher exact test) for categorical variables in R Foundation for Statistical Computing version 3.1.0. All samples were 2-tailed. A P value < .05 was considered statistically significant. Using the smaller of the 2 study populations, the investigators calculated that the given sample size of 88 in each group would provide 99% power to detect a 2-day difference in the primary endpoint at a 2-sided significance level of 5%.

Results

During the baseline assessment (group 1), 192 cases were reviewed with 103 meeting the inclusion criteria. Group 1 consisted of 85 cases of CAP and 18 cases of HCAP (mean age, 70.7 years). During the follow-up assessment (group 2), 168 cases were reviewed with 88 meeting the inclusion criteria. Group 2 consisted of 68 cases of CAP and 20 cases of HCAP (mean age, 70.8 years).

There was no difference in inpatient mortality rates between groups (3.1% vs 3.0%, P = .99). This mortality rate is consistent with published reports.²³ Empiric antibiotic selection was appropriate because there were no exclusions for drug/pathogen mismatch. Pneumonia severity was similar in both groups (Table).

The total duration of antibiotic treatment decreased significantly for CAP and HCAP (Figure). The observed median treatment days for groups 1 and 2 were 11 days and 8 days, respectively. Outpatient antibiotic days also decreased. Mean LOS was shorter in the follow-up group (4.9 ± 2.6 days vs 4.0 ± 2.6 days, P = .02). Length of IV antibiotic duration decreased. Oral antibiotic days while inpatient were not statistically different (1.5 ± 1.8 days vs 1.1 ± 1.5 days, P = .15). During the follow-up period, 26 stewardship notes were entered into CPRS; antibiotics were stopped in 65% of cases.

There were no recorded cases of CDI in either group. There were eleven 28-day readmissions in group 1, only 3 of which were due to infectious causes. One patient had a primary diagnosis of necrotizing pneumonia, 1 had Pseudomonas pneumonia, and 1 patient had a new lung mass and was diagnosed with postobstructive pneumonia. Of eight 28-day readmissions in group 2, only 2 resulted from infectious causes. One readmission primary diagnosis was sinusitis and 1 was recurrent pneumonia (of note, this patient received a 10-day treatment course for pneumonia on initial admission). Two patients died within 28 days of discharge in each group.

Discussion

Other multifaceted single-center interventions have been shown to be effective in large, teaching hospitals,^24,25 and it has been suggested that smaller, rural hospitals may be underserved in antimicrobial stewardship activities.^26,27 In the global struggle with antimicrobial resistance, McGregor and colleagues highlighted the importance of evaluating successful stewardship methods in an array of clinical settings to help tailor an approach for a specific type of facility.²⁸ To the authors knowledge, this is the first publication showing efficacy of such antimicrobial stewardship interventions specific to pneumonia therapy in a small, primary facility.

The intervention methods used at VHSO are supported by recent IDSA and Society for Healthcare Epidemiology of America guidelines for effective stewardship implementation.²⁹ Prospective audit and feedback is considered a core recommendation, whereas didactic education is recommended only in conjunction with other stewardship activities. Additionally, the guidelines recommend evaluating specific infectious disease syndromes, in this case uncomplicated pneumonia, to focus on specific treatment guidelines. Last, the results of the 3-part intervention can be used to aid in demonstrating facility improvement and encourage continued success.

Of note, VHSO has had established inpatient and outpatient clinical pharmacy roles for several years. Stewardship interventions already in place included an intravenous-to-oral antibiotic switch policy, automatic antibiotic stop dates, as well as pharmacist-driven vancomycin and aminoglycoside dosing. Prior to this multifaceted intervention specific to pneumonia duration, prospective audit and feedback interventions (verbal and written) also were common. The number of interventions specific to this study outside of the stewardship note was not recorded. Using rapid diagnostic testing and biomarkers to aid in stewardship activities at VHSO have been considered, but these tools are not available due to a lab personnel shortage.

Soliciting feedback from providers on their preferred stewardship strategy and perceived barriers was a key component of the educational intervention. Of equal importance was presenting providers with their baseline prescribing data to provide objective evidence of a problem. While all were familiar with existing treatment guidelines, some feedback indicated that it can be difficult to determine accurate antibiotic duration in CPRS. Prescribers reported that identifying antibiotic duration was especially challenging when antibiotics as well as providers change during an admission. Also frequently overlooked were antibiotics given in the emergency department. This could be a key area for clinical pharmacists’ intervention given their familiarity with the CPRS medication sections.

Charani and colleagues suggest that recognizing barriers to implementing best practices and adapting to the local facility culture is paramount for changing prescribing behaviors and developing a successful stewardship intervention.³⁰ At VHSO, the providers were presented with multiple stewardship options but agreed to the new note and template. This process gave providers a voice in selecting their own stewardship intervention. In a culture with no infectious disease physician to champion initiatives, the investigators felt that provider involvement in the intervention selection was unique and may have encouraged provider concurrence.

Although not directly targeted by the intervention strategies, average LOS was shorter in the follow-up group. According to investigators, frequent reminders of clinical stability in the stewardship notes may have influenced this. Even though the note was used only in patients who remained hospitalized for their entire treatment course, investigators felt that it still served as a reminder for prescribing habits as they were also able to show a decrease in outpatient prescription duration.

Limitations

Potential weaknesses of the study include changes in providers. During the transition between group 1 and group 2, 2 hospitalists left and 2 new hospitalists arrived. Given the small size of the staff, this could significantly impact prescribing trends. Another potential weakness is the high exclusion rate, although these rates were similar in both groups (46% group 1, 47% group 2). Furthermore, similar exclusion rates have been reported elsewhere.^24,25,31 The most common reasons for exclusion were complicated pneumonias (36%) and immunocompromised patients (18%). These patient populations were not evaluated in the current study, and optimal treatment durations are unknown. Hospital-acquired and ventilator-associated pneumonias also were excluded. Therefore, limitations in applicability of the results should be noted.

The authors acknowledge that, prior to this publication, the IDSA guidelines have removed the designation of HCAP as a separate clinical entity.⁴ However, this should not affect the significance of the intervention for treatment duration.

The study facility experienced a hiring freeze resulting in a 9.3% decrease in overall admissions from fiscal year 2013 to fiscal year 2015. This is likely why there were fewer admissions for pneumonia in group 2. Regardless, power analysis revealed the study was of adequate sample size to detect its primary outcome. It is possible that patients in either group could have sought health care at other facilities, making the CDI and readmission endpoints less inclusive.

The study was not of a scale to detect changes in antimicrobial resistance pressure or clinical outcomes. Cost savings were not analyzed. However, this study adds to the growing body of evidence that a structured intervention can result in positive outcomes at the facility level. This study shows that interventions targeting pneumonia treatment duration could feasibly be added to the menu of stewardship options available to smaller facilities.

Like other stewardship studies in the literature, the follow-up treatment duration, while improved, still exceeded those recommended in the IDSA guidelines. The investigators noted that not all providers were equal regarding change in prescribing habits, perhaps making the average duration longer. Additionally, the request to discontinue antibiotic therapy through the stewardship note could have been entered earlier (eg, as early as day 5 of therapy) to target the shortest effective date as recommended in the recent stewardship guidelines.²⁹ Future steps include continued feedback to providers on their progress in this area and encouragement to document day of antibiotic treatment in their daily progress notes.

Conclusion

This study showed a significant decrease in antibiotic duration for the treatment of uncomplicated pneumonia using a 3-part pharmacy intervention in a primary hospital setting. The investigators feel that each arm of the strategy was equally important and fewer interventions were not likely to be as effective.³² Although data collection for baseline prescribing and follow-up on outcomes may be a time-consuming task, it can be a valuable component of successful stewardship interventions.

The safety and the efficacy of shorter durations of antibiotic therapy for uncomplicated pneumonia have been clearly established in the past decade.^1,2 Guidelines from the Infectious Diseases Society of America (IDSA) and the American Thoracic Society have been available since 2007. These expert consensus statements recommend that uncomplicated community-acquired pneumonia (CAP) should be treated for 5 to 7 days, as long as the patient exhibits signs and symptoms of clinical stability.³ Similarly, recently updated guidelines for hospital-acquired and ventilator-associated pneumonias call for short-course therapy.⁴ Despite this guidance, pneumonia treatment duration is often discordant.⁵ Unnecessary antimicrobial use is associated with greater selection pressure on pathogens, increased risk of adverse events (AEs), and elevated treatment costs.⁶ The growing burden of antibiotic resistance coupled with limited availability of new antibiotics requires judicious use of these agents.

The IDSA guidelines for Clostridium difficile infection (CDI) note that exposure to antimicrobial agents is the most important modifiable risk factor for the development of CDI.⁷ Longer durations of antibiotics increase the risk of CDI compared with shorter durations.^8,9 Antibiotics are a frequent cause of drug-associated AEs and likely are underestimated.¹⁰ To decrease the unwanted effects of excessive therapy, IDSA and CDC suggest that antimicrobial stewardship interventions should be implemented.^11-13

Antimicrobial stewardship efforts in small community hospitals (also known as district, rural, general, and primary hospitals) are varied and can be challenging due to limited staff and resources.^14,15 The World Health Organization defines a primary care facility as having few specialties, mainly internal medicine and general surgery with limited laboratory services for general (but not specialized) pathologic analysis, and bed size ranging from 30 to 200 beds.¹⁶ Although guidance is available for effective intervention strategies in smaller hospitals, there are limited data in the literature regarding successful outcomes.^17-22

The purpose of this study was to establish the need and evaluate the impact of a pharmacy-initiated 3-part intervention targeting treatment duration in patients hospitalized with uncomplicated pneumonia in a primary hospital setting. The Veterans Health Care System of the Ozarks (VHSO) in Fayetteville, Arkansas, has 50 acute care beds, including 7 intensive care unit beds and excluding 15 mental health beds. The pharmacy is staffed 24 hours a day. Acute-care providers consist of 7 full-time hospitalists, not including nocturnists and contract physicians. The VHSO does not have an infectious disease physician on staff.

The antimicrobial stewardship committee consists of 3 clinical pharmacists, a pulmonologist, a pathologist, and 2 infection-control nurses. There is 1 full-time equivalent allotted for inpatient clinical pharmacy activities in the acute care areas, including enforcement of all antimicrobial stewardship policies, which are conducted by a single pharmacist.

Methods

This was a retrospective chart review of two 12-month periods using a before and after study design. Medical records were reviewed during October 2012 through September 2013 (before the stewardship implementation) and December 2014 through November 2015 (after implementation). Inclusion criteria consisted of a primary discharge diagnosis of pneumonia as documented by the provider (or secondary diagnosis if sepsis was primary), hospitalization for at least 48 hours, administration of antibiotics for a minimum of 24 hours, and survival to discharge.

Exclusion criteria consisted of direct transfer from another facility, inappropriate empiric therapy as evidenced by culture data (isolated pathogens not covered by prescribed antibiotics), pneumonia that developed 48 hours after admission, extrapulmonary sources of infection, hospitalization > 14 days, discharge without a known duration of outpatient antibiotics, discharge for pneumonia within 28 days prior to admission, documented infection caused by Pseudomonas aeruginosa or other nonlactose fermenting Gram-negative rod, and complicated pneumonias defined as lung abscess, empyema, or severe immunosuppression (eg, cancer with chemotherapy within the previous 30 days, transplant recipients, HIV infection, acquired or congenital immunodeficiency, or absolute neutrophil count 1,500 cell/mm³ within past 28 days).

Patients were designated with health care-associated pneumonia (HCAP) if they were hospitalized ≥ 2 days or resided in a skilled nursing or extended-care facility within the previous 90 days; on chronic dialysis; or had wound care, tracheostomy care, or ventilator care from a health care professional within the previous 28 days. Criteria for clinical stability were defined as ≤ 100.4º F temperature, ≤ 100 beats/min heart rate, ≤ 24 breaths/min respiratory rate, ≥ 90 mm Hg systolic blood pressure, ≥ 90% or PaO₂ ≥ 60 mm Hg oxygen saturation on room air (or baseline oxygen requirements), and return to baseline mental status. To compare groups, researchers tabulated the pneumonia severity index on hospital day 1.

The intervention consisted of a 3-part process. First, hospitalists were educated on VHSO’s baseline treatment duration data, and these were compared with current IDSA recommendations. The education was followed by an open-discussion component to solicit feedback from providers on perceived barriers to following guidelines. Provider feedback was used to tailor an antimicrobial stewardship intervention to address perceived barriers to optimal antibiotic treatment duration.

After the education component, prospective intervention and feedback were provided for hospitalized patients by a single clinical pharmacist. This pharmacist interacted verbally and in writing with the patients’ providers, discussing antimicrobial appropriateness, de-escalation, duration of therapy, and intravenous to oral switching. Finally, a stewardship note for the Computerized Patient Record System (CPRS) was generated and included a template with reminders of clinical stability, duration of current therapy, and a request to discontinue therapy if the patient met criteria. For patients who remained hospitalized, this note was entered into CPRS on or about day 7 of antibiotic therapy; this required an electronic signature from the provider.

The VHSO Pharmacy and Therapeutics Committee approved both the provider education and the stewardship note in November 2014, and implementation of the stewardship intervention occurred immediately afterward. The pharmacy staff also was educated on the VHSO baseline data and stewardship efforts.

The primary outcome of the study was the change in days of total antibiotic treatment. Secondary outcomes included days of intravenous antibiotic therapy, days of inpatient oral therapy, mean length of stay (LOS), and number of outpatient antibiotic days once discharged. Incidence of CDI and 28-day readmissions were also evaluated. The VHSO Institutional Review Board approved these methods and the procedures that followed were in accord with the ethical standards of the VHSO Committee on Human Experimentation.

Statistical Analysis

All continuous variables are reported as mean ± standard deviation. Data analysis for significance was performed using a Student t test for continuous variables and a χ² test (or Fisher exact test) for categorical variables in R Foundation for Statistical Computing version 3.1.0. All samples were 2-tailed. A P value < .05 was considered statistically significant. Using the smaller of the 2 study populations, the investigators calculated that the given sample size of 88 in each group would provide 99% power to detect a 2-day difference in the primary endpoint at a 2-sided significance level of 5%.

Results

During the baseline assessment (group 1), 192 cases were reviewed with 103 meeting the inclusion criteria. Group 1 consisted of 85 cases of CAP and 18 cases of HCAP (mean age, 70.7 years). During the follow-up assessment (group 2), 168 cases were reviewed with 88 meeting the inclusion criteria. Group 2 consisted of 68 cases of CAP and 20 cases of HCAP (mean age, 70.8 years).

There was no difference in inpatient mortality rates between groups (3.1% vs 3.0%, P = .99). This mortality rate is consistent with published reports.²³ Empiric antibiotic selection was appropriate because there were no exclusions for drug/pathogen mismatch. Pneumonia severity was similar in both groups (Table).

The total duration of antibiotic treatment decreased significantly for CAP and HCAP (Figure). The observed median treatment days for groups 1 and 2 were 11 days and 8 days, respectively. Outpatient antibiotic days also decreased. Mean LOS was shorter in the follow-up group (4.9 ± 2.6 days vs 4.0 ± 2.6 days, P = .02). Length of IV antibiotic duration decreased. Oral antibiotic days while inpatient were not statistically different (1.5 ± 1.8 days vs 1.1 ± 1.5 days, P = .15). During the follow-up period, 26 stewardship notes were entered into CPRS; antibiotics were stopped in 65% of cases.

There were no recorded cases of CDI in either group. There were eleven 28-day readmissions in group 1, only 3 of which were due to infectious causes. One patient had a primary diagnosis of necrotizing pneumonia, 1 had Pseudomonas pneumonia, and 1 patient had a new lung mass and was diagnosed with postobstructive pneumonia. Of eight 28-day readmissions in group 2, only 2 resulted from infectious causes. One readmission primary diagnosis was sinusitis and 1 was recurrent pneumonia (of note, this patient received a 10-day treatment course for pneumonia on initial admission). Two patients died within 28 days of discharge in each group.

Discussion

Other multifaceted single-center interventions have been shown to be effective in large, teaching hospitals,^24,25 and it has been suggested that smaller, rural hospitals may be underserved in antimicrobial stewardship activities.^26,27 In the global struggle with antimicrobial resistance, McGregor and colleagues highlighted the importance of evaluating successful stewardship methods in an array of clinical settings to help tailor an approach for a specific type of facility.²⁸ To the authors knowledge, this is the first publication showing efficacy of such antimicrobial stewardship interventions specific to pneumonia therapy in a small, primary facility.

The intervention methods used at VHSO are supported by recent IDSA and Society for Healthcare Epidemiology of America guidelines for effective stewardship implementation.²⁹ Prospective audit and feedback is considered a core recommendation, whereas didactic education is recommended only in conjunction with other stewardship activities. Additionally, the guidelines recommend evaluating specific infectious disease syndromes, in this case uncomplicated pneumonia, to focus on specific treatment guidelines. Last, the results of the 3-part intervention can be used to aid in demonstrating facility improvement and encourage continued success.

Of note, VHSO has had established inpatient and outpatient clinical pharmacy roles for several years. Stewardship interventions already in place included an intravenous-to-oral antibiotic switch policy, automatic antibiotic stop dates, as well as pharmacist-driven vancomycin and aminoglycoside dosing. Prior to this multifaceted intervention specific to pneumonia duration, prospective audit and feedback interventions (verbal and written) also were common. The number of interventions specific to this study outside of the stewardship note was not recorded. Using rapid diagnostic testing and biomarkers to aid in stewardship activities at VHSO have been considered, but these tools are not available due to a lab personnel shortage.

Soliciting feedback from providers on their preferred stewardship strategy and perceived barriers was a key component of the educational intervention. Of equal importance was presenting providers with their baseline prescribing data to provide objective evidence of a problem. While all were familiar with existing treatment guidelines, some feedback indicated that it can be difficult to determine accurate antibiotic duration in CPRS. Prescribers reported that identifying antibiotic duration was especially challenging when antibiotics as well as providers change during an admission. Also frequently overlooked were antibiotics given in the emergency department. This could be a key area for clinical pharmacists’ intervention given their familiarity with the CPRS medication sections.

Charani and colleagues suggest that recognizing barriers to implementing best practices and adapting to the local facility culture is paramount for changing prescribing behaviors and developing a successful stewardship intervention.³⁰ At VHSO, the providers were presented with multiple stewardship options but agreed to the new note and template. This process gave providers a voice in selecting their own stewardship intervention. In a culture with no infectious disease physician to champion initiatives, the investigators felt that provider involvement in the intervention selection was unique and may have encouraged provider concurrence.

Although not directly targeted by the intervention strategies, average LOS was shorter in the follow-up group. According to investigators, frequent reminders of clinical stability in the stewardship notes may have influenced this. Even though the note was used only in patients who remained hospitalized for their entire treatment course, investigators felt that it still served as a reminder for prescribing habits as they were also able to show a decrease in outpatient prescription duration.

Limitations

Potential weaknesses of the study include changes in providers. During the transition between group 1 and group 2, 2 hospitalists left and 2 new hospitalists arrived. Given the small size of the staff, this could significantly impact prescribing trends. Another potential weakness is the high exclusion rate, although these rates were similar in both groups (46% group 1, 47% group 2). Furthermore, similar exclusion rates have been reported elsewhere.^24,25,31 The most common reasons for exclusion were complicated pneumonias (36%) and immunocompromised patients (18%). These patient populations were not evaluated in the current study, and optimal treatment durations are unknown. Hospital-acquired and ventilator-associated pneumonias also were excluded. Therefore, limitations in applicability of the results should be noted.

The authors acknowledge that, prior to this publication, the IDSA guidelines have removed the designation of HCAP as a separate clinical entity.⁴ However, this should not affect the significance of the intervention for treatment duration.

The study facility experienced a hiring freeze resulting in a 9.3% decrease in overall admissions from fiscal year 2013 to fiscal year 2015. This is likely why there were fewer admissions for pneumonia in group 2. Regardless, power analysis revealed the study was of adequate sample size to detect its primary outcome. It is possible that patients in either group could have sought health care at other facilities, making the CDI and readmission endpoints less inclusive.

The study was not of a scale to detect changes in antimicrobial resistance pressure or clinical outcomes. Cost savings were not analyzed. However, this study adds to the growing body of evidence that a structured intervention can result in positive outcomes at the facility level. This study shows that interventions targeting pneumonia treatment duration could feasibly be added to the menu of stewardship options available to smaller facilities.

Like other stewardship studies in the literature, the follow-up treatment duration, while improved, still exceeded those recommended in the IDSA guidelines. The investigators noted that not all providers were equal regarding change in prescribing habits, perhaps making the average duration longer. Additionally, the request to discontinue antibiotic therapy through the stewardship note could have been entered earlier (eg, as early as day 5 of therapy) to target the shortest effective date as recommended in the recent stewardship guidelines.²⁹ Future steps include continued feedback to providers on their progress in this area and encouragement to document day of antibiotic treatment in their daily progress notes.

Conclusion

This study showed a significant decrease in antibiotic duration for the treatment of uncomplicated pneumonia using a 3-part pharmacy intervention in a primary hospital setting. The investigators feel that each arm of the strategy was equally important and fewer interventions were not likely to be as effective.³² Although data collection for baseline prescribing and follow-up on outcomes may be a time-consuming task, it can be a valuable component of successful stewardship interventions.

The safety and the efficacy of shorter durations of antibiotic therapy for uncomplicated pneumonia have been clearly established in the past decade.^1,2 Guidelines from the Infectious Diseases Society of America (IDSA) and the American Thoracic Society have been available since 2007. These expert consensus statements recommend that uncomplicated community-acquired pneumonia (CAP) should be treated for 5 to 7 days, as long as the patient exhibits signs and symptoms of clinical stability.³ Similarly, recently updated guidelines for hospital-acquired and ventilator-associated pneumonias call for short-course therapy.⁴ Despite this guidance, pneumonia treatment duration is often discordant.⁵ Unnecessary antimicrobial use is associated with greater selection pressure on pathogens, increased risk of adverse events (AEs), and elevated treatment costs.⁶ The growing burden of antibiotic resistance coupled with limited availability of new antibiotics requires judicious use of these agents.

The IDSA guidelines for Clostridium difficile infection (CDI) note that exposure to antimicrobial agents is the most important modifiable risk factor for the development of CDI.⁷ Longer durations of antibiotics increase the risk of CDI compared with shorter durations.^8,9 Antibiotics are a frequent cause of drug-associated AEs and likely are underestimated.¹⁰ To decrease the unwanted effects of excessive therapy, IDSA and CDC suggest that antimicrobial stewardship interventions should be implemented.^11-13

Antimicrobial stewardship efforts in small community hospitals (also known as district, rural, general, and primary hospitals) are varied and can be challenging due to limited staff and resources.^14,15 The World Health Organization defines a primary care facility as having few specialties, mainly internal medicine and general surgery with limited laboratory services for general (but not specialized) pathologic analysis, and bed size ranging from 30 to 200 beds.¹⁶ Although guidance is available for effective intervention strategies in smaller hospitals, there are limited data in the literature regarding successful outcomes.^17-22

The purpose of this study was to establish the need and evaluate the impact of a pharmacy-initiated 3-part intervention targeting treatment duration in patients hospitalized with uncomplicated pneumonia in a primary hospital setting. The Veterans Health Care System of the Ozarks (VHSO) in Fayetteville, Arkansas, has 50 acute care beds, including 7 intensive care unit beds and excluding 15 mental health beds. The pharmacy is staffed 24 hours a day. Acute-care providers consist of 7 full-time hospitalists, not including nocturnists and contract physicians. The VHSO does not have an infectious disease physician on staff.

The antimicrobial stewardship committee consists of 3 clinical pharmacists, a pulmonologist, a pathologist, and 2 infection-control nurses. There is 1 full-time equivalent allotted for inpatient clinical pharmacy activities in the acute care areas, including enforcement of all antimicrobial stewardship policies, which are conducted by a single pharmacist.

Methods

This was a retrospective chart review of two 12-month periods using a before and after study design. Medical records were reviewed during October 2012 through September 2013 (before the stewardship implementation) and December 2014 through November 2015 (after implementation). Inclusion criteria consisted of a primary discharge diagnosis of pneumonia as documented by the provider (or secondary diagnosis if sepsis was primary), hospitalization for at least 48 hours, administration of antibiotics for a minimum of 24 hours, and survival to discharge.

Exclusion criteria consisted of direct transfer from another facility, inappropriate empiric therapy as evidenced by culture data (isolated pathogens not covered by prescribed antibiotics), pneumonia that developed 48 hours after admission, extrapulmonary sources of infection, hospitalization > 14 days, discharge without a known duration of outpatient antibiotics, discharge for pneumonia within 28 days prior to admission, documented infection caused by Pseudomonas aeruginosa or other nonlactose fermenting Gram-negative rod, and complicated pneumonias defined as lung abscess, empyema, or severe immunosuppression (eg, cancer with chemotherapy within the previous 30 days, transplant recipients, HIV infection, acquired or congenital immunodeficiency, or absolute neutrophil count 1,500 cell/mm³ within past 28 days).

Patients were designated with health care-associated pneumonia (HCAP) if they were hospitalized ≥ 2 days or resided in a skilled nursing or extended-care facility within the previous 90 days; on chronic dialysis; or had wound care, tracheostomy care, or ventilator care from a health care professional within the previous 28 days. Criteria for clinical stability were defined as ≤ 100.4º F temperature, ≤ 100 beats/min heart rate, ≤ 24 breaths/min respiratory rate, ≥ 90 mm Hg systolic blood pressure, ≥ 90% or PaO₂ ≥ 60 mm Hg oxygen saturation on room air (or baseline oxygen requirements), and return to baseline mental status. To compare groups, researchers tabulated the pneumonia severity index on hospital day 1.

The intervention consisted of a 3-part process. First, hospitalists were educated on VHSO’s baseline treatment duration data, and these were compared with current IDSA recommendations. The education was followed by an open-discussion component to solicit feedback from providers on perceived barriers to following guidelines. Provider feedback was used to tailor an antimicrobial stewardship intervention to address perceived barriers to optimal antibiotic treatment duration.

After the education component, prospective intervention and feedback were provided for hospitalized patients by a single clinical pharmacist. This pharmacist interacted verbally and in writing with the patients’ providers, discussing antimicrobial appropriateness, de-escalation, duration of therapy, and intravenous to oral switching. Finally, a stewardship note for the Computerized Patient Record System (CPRS) was generated and included a template with reminders of clinical stability, duration of current therapy, and a request to discontinue therapy if the patient met criteria. For patients who remained hospitalized, this note was entered into CPRS on or about day 7 of antibiotic therapy; this required an electronic signature from the provider.

The VHSO Pharmacy and Therapeutics Committee approved both the provider education and the stewardship note in November 2014, and implementation of the stewardship intervention occurred immediately afterward. The pharmacy staff also was educated on the VHSO baseline data and stewardship efforts.

The primary outcome of the study was the change in days of total antibiotic treatment. Secondary outcomes included days of intravenous antibiotic therapy, days of inpatient oral therapy, mean length of stay (LOS), and number of outpatient antibiotic days once discharged. Incidence of CDI and 28-day readmissions were also evaluated. The VHSO Institutional Review Board approved these methods and the procedures that followed were in accord with the ethical standards of the VHSO Committee on Human Experimentation.

Statistical Analysis

All continuous variables are reported as mean ± standard deviation. Data analysis for significance was performed using a Student t test for continuous variables and a χ² test (or Fisher exact test) for categorical variables in R Foundation for Statistical Computing version 3.1.0. All samples were 2-tailed. A P value < .05 was considered statistically significant. Using the smaller of the 2 study populations, the investigators calculated that the given sample size of 88 in each group would provide 99% power to detect a 2-day difference in the primary endpoint at a 2-sided significance level of 5%.

Results

During the baseline assessment (group 1), 192 cases were reviewed with 103 meeting the inclusion criteria. Group 1 consisted of 85 cases of CAP and 18 cases of HCAP (mean age, 70.7 years). During the follow-up assessment (group 2), 168 cases were reviewed with 88 meeting the inclusion criteria. Group 2 consisted of 68 cases of CAP and 20 cases of HCAP (mean age, 70.8 years).

There was no difference in inpatient mortality rates between groups (3.1% vs 3.0%, P = .99). This mortality rate is consistent with published reports.²³ Empiric antibiotic selection was appropriate because there were no exclusions for drug/pathogen mismatch. Pneumonia severity was similar in both groups (Table).

The total duration of antibiotic treatment decreased significantly for CAP and HCAP (Figure). The observed median treatment days for groups 1 and 2 were 11 days and 8 days, respectively. Outpatient antibiotic days also decreased. Mean LOS was shorter in the follow-up group (4.9 ± 2.6 days vs 4.0 ± 2.6 days, P = .02). Length of IV antibiotic duration decreased. Oral antibiotic days while inpatient were not statistically different (1.5 ± 1.8 days vs 1.1 ± 1.5 days, P = .15). During the follow-up period, 26 stewardship notes were entered into CPRS; antibiotics were stopped in 65% of cases.

There were no recorded cases of CDI in either group. There were eleven 28-day readmissions in group 1, only 3 of which were due to infectious causes. One patient had a primary diagnosis of necrotizing pneumonia, 1 had Pseudomonas pneumonia, and 1 patient had a new lung mass and was diagnosed with postobstructive pneumonia. Of eight 28-day readmissions in group 2, only 2 resulted from infectious causes. One readmission primary diagnosis was sinusitis and 1 was recurrent pneumonia (of note, this patient received a 10-day treatment course for pneumonia on initial admission). Two patients died within 28 days of discharge in each group.

Discussion

Other multifaceted single-center interventions have been shown to be effective in large, teaching hospitals,^24,25 and it has been suggested that smaller, rural hospitals may be underserved in antimicrobial stewardship activities.^26,27 In the global struggle with antimicrobial resistance, McGregor and colleagues highlighted the importance of evaluating successful stewardship methods in an array of clinical settings to help tailor an approach for a specific type of facility.²⁸ To the authors knowledge, this is the first publication showing efficacy of such antimicrobial stewardship interventions specific to pneumonia therapy in a small, primary facility.

The intervention methods used at VHSO are supported by recent IDSA and Society for Healthcare Epidemiology of America guidelines for effective stewardship implementation.²⁹ Prospective audit and feedback is considered a core recommendation, whereas didactic education is recommended only in conjunction with other stewardship activities. Additionally, the guidelines recommend evaluating specific infectious disease syndromes, in this case uncomplicated pneumonia, to focus on specific treatment guidelines. Last, the results of the 3-part intervention can be used to aid in demonstrating facility improvement and encourage continued success.

Of note, VHSO has had established inpatient and outpatient clinical pharmacy roles for several years. Stewardship interventions already in place included an intravenous-to-oral antibiotic switch policy, automatic antibiotic stop dates, as well as pharmacist-driven vancomycin and aminoglycoside dosing. Prior to this multifaceted intervention specific to pneumonia duration, prospective audit and feedback interventions (verbal and written) also were common. The number of interventions specific to this study outside of the stewardship note was not recorded. Using rapid diagnostic testing and biomarkers to aid in stewardship activities at VHSO have been considered, but these tools are not available due to a lab personnel shortage.

Soliciting feedback from providers on their preferred stewardship strategy and perceived barriers was a key component of the educational intervention. Of equal importance was presenting providers with their baseline prescribing data to provide objective evidence of a problem. While all were familiar with existing treatment guidelines, some feedback indicated that it can be difficult to determine accurate antibiotic duration in CPRS. Prescribers reported that identifying antibiotic duration was especially challenging when antibiotics as well as providers change during an admission. Also frequently overlooked were antibiotics given in the emergency department. This could be a key area for clinical pharmacists’ intervention given their familiarity with the CPRS medication sections.

Charani and colleagues suggest that recognizing barriers to implementing best practices and adapting to the local facility culture is paramount for changing prescribing behaviors and developing a successful stewardship intervention.³⁰ At VHSO, the providers were presented with multiple stewardship options but agreed to the new note and template. This process gave providers a voice in selecting their own stewardship intervention. In a culture with no infectious disease physician to champion initiatives, the investigators felt that provider involvement in the intervention selection was unique and may have encouraged provider concurrence.

Although not directly targeted by the intervention strategies, average LOS was shorter in the follow-up group. According to investigators, frequent reminders of clinical stability in the stewardship notes may have influenced this. Even though the note was used only in patients who remained hospitalized for their entire treatment course, investigators felt that it still served as a reminder for prescribing habits as they were also able to show a decrease in outpatient prescription duration.

Limitations

Potential weaknesses of the study include changes in providers. During the transition between group 1 and group 2, 2 hospitalists left and 2 new hospitalists arrived. Given the small size of the staff, this could significantly impact prescribing trends. Another potential weakness is the high exclusion rate, although these rates were similar in both groups (46% group 1, 47% group 2). Furthermore, similar exclusion rates have been reported elsewhere.^24,25,31 The most common reasons for exclusion were complicated pneumonias (36%) and immunocompromised patients (18%). These patient populations were not evaluated in the current study, and optimal treatment durations are unknown. Hospital-acquired and ventilator-associated pneumonias also were excluded. Therefore, limitations in applicability of the results should be noted.

The authors acknowledge that, prior to this publication, the IDSA guidelines have removed the designation of HCAP as a separate clinical entity.⁴ However, this should not affect the significance of the intervention for treatment duration.

The study facility experienced a hiring freeze resulting in a 9.3% decrease in overall admissions from fiscal year 2013 to fiscal year 2015. This is likely why there were fewer admissions for pneumonia in group 2. Regardless, power analysis revealed the study was of adequate sample size to detect its primary outcome. It is possible that patients in either group could have sought health care at other facilities, making the CDI and readmission endpoints less inclusive.

The study was not of a scale to detect changes in antimicrobial resistance pressure or clinical outcomes. Cost savings were not analyzed. However, this study adds to the growing body of evidence that a structured intervention can result in positive outcomes at the facility level. This study shows that interventions targeting pneumonia treatment duration could feasibly be added to the menu of stewardship options available to smaller facilities.

Like other stewardship studies in the literature, the follow-up treatment duration, while improved, still exceeded those recommended in the IDSA guidelines. The investigators noted that not all providers were equal regarding change in prescribing habits, perhaps making the average duration longer. Additionally, the request to discontinue antibiotic therapy through the stewardship note could have been entered earlier (eg, as early as day 5 of therapy) to target the shortest effective date as recommended in the recent stewardship guidelines.²⁹ Future steps include continued feedback to providers on their progress in this area and encouragement to document day of antibiotic treatment in their daily progress notes.

Conclusion

This study showed a significant decrease in antibiotic duration for the treatment of uncomplicated pneumonia using a 3-part pharmacy intervention in a primary hospital setting. The investigators feel that each arm of the strategy was equally important and fewer interventions were not likely to be as effective.³² Although data collection for baseline prescribing and follow-up on outcomes may be a time-consuming task, it can be a valuable component of successful stewardship interventions.

ORLANDO – A uniquely designed multielectrode radiofrequency ablation (RFA) balloon catheter system for the treatment of atrial fibrillation (AF) performed well in a first-in-man study.

The new ablation system is designed to provide the flexibility of conventional RFA devices in treating a broad array of AF triggers with the type of predictable energy delivery more closely associated with cryoballoon ablation, according to the principal investigator, Matthew G. Daly, MB, ChB, a cardiologist at Christchurch (New Zealand) Hospital.

The inflatable experimental device features 18 electrodes, a built-in camera, integrated mapping and pacing, and irrigation designed to reduce the risk of clot formation. On contact, the 12 electrodes situated on the equator of the spherical device, along with the six electrodes situated on the polar ends, are initially employed to select the ablation pattern. RFA can be delivered immediately through the same electrodes once proper contact is established using the built-in cameras for real-time visualization.

Dr. Daly reported no industry relationships relevant to this study.

ORLANDO – A uniquely designed multielectrode radiofrequency ablation (RFA) balloon catheter system for the treatment of atrial fibrillation (AF) performed well in a first-in-man study.

The new ablation system is designed to provide the flexibility of conventional RFA devices in treating a broad array of AF triggers with the type of predictable energy delivery more closely associated with cryoballoon ablation, according to the principal investigator, Matthew G. Daly, MB, ChB, a cardiologist at Christchurch (New Zealand) Hospital.

The inflatable experimental device features 18 electrodes, a built-in camera, integrated mapping and pacing, and irrigation designed to reduce the risk of clot formation. On contact, the 12 electrodes situated on the equator of the spherical device, along with the six electrodes situated on the polar ends, are initially employed to select the ablation pattern. RFA can be delivered immediately through the same electrodes once proper contact is established using the built-in cameras for real-time visualization.

Dr. Daly reported no industry relationships relevant to this study.

ORLANDO – A uniquely designed multielectrode radiofrequency ablation (RFA) balloon catheter system for the treatment of atrial fibrillation (AF) performed well in a first-in-man study.

The new ablation system is designed to provide the flexibility of conventional RFA devices in treating a broad array of AF triggers with the type of predictable energy delivery more closely associated with cryoballoon ablation, according to the principal investigator, Matthew G. Daly, MB, ChB, a cardiologist at Christchurch (New Zealand) Hospital.

The inflatable experimental device features 18 electrodes, a built-in camera, integrated mapping and pacing, and irrigation designed to reduce the risk of clot formation. On contact, the 12 electrodes situated on the equator of the spherical device, along with the six electrodes situated on the polar ends, are initially employed to select the ablation pattern. RFA can be delivered immediately through the same electrodes once proper contact is established using the built-in cameras for real-time visualization.

Dr. Daly reported no industry relationships relevant to this study.

Some 15 years ago, when Daniel Roberts, MD, FHM, decided at the end of his medical residency that his career path was going to be that of a hospitalist, he heard the same thing. A lot.

“Geesh, don’t you think you’re going to burn out?”

The reasons for such a response are well known in HM circles: the 7-on, 7-off shift structure; the constant rounding; the push-pull between clinical, administrative, and – what many would term – clerical work.

Darrin Klimek/Thinkstock

• Work effort.

• Work efficiency.

• Work-home interference.

• A sense of meaning.

• “Flexibility, control, and autonomy.”

Basically, the five drivers lead to this: Physicians who work too much and too inefficiently, with too little control and sense of purpose, end up flaming out more so than do doctors who work fewer hours, with fewer obstacles – all the while feeling satisfied with their autonomy and value.

Academic hospitalist John Yoon, MD, assistant professor of medicine at the University of Chicago, says that health care has to work harder to promote its benefits as being more important than a highly paid profession. Instead, health care should focus on giving meaning to its practitioners.

“I think it is time for leaders of HM groups to honestly discuss the intrinsic meaning and essential ‘calling’ of what it means to be a good hospitalist,” Dr. Yoon wrote in an email interview with The Hospitalist. “What can we do to make the hospitalist vocation a meaningful, long-term career, so that they do not feel like simply revenue-generating ‘pawns’ in a medical-bureaucratic system?”

A ‘meaningful’ career

The modern discussion of burnout as a phenomenon traces back to the Maslach Burnout Inventory, a three-pronged test that measures emotional exhaustion, depersonalization, and personal accomplishment.¹ But why does burnout hit physicians – hospitalists, in particular – so intensely? In part, it’s because – like their predecessors in emergency medicine – hospitalists are responsible for managing the care of patients other specialties consult with, operate on, or for whom they run tests.

“Once the patients come up from the emergency room or get admitted to the hospital from the outside, the hospitalist is the one who is largely running that show,” said Dr. West, whose researchshows that HM doctors suffer burnout more than the average across medical specialties.² “So they’re the front line of inpatient medicine.”

Another factor contributing to burnout’s impact on hospitalists is that the specialty’s rank and file (by definition) work within the walls of institutions that have a lot of contentious and complicated issues that – while outside the purview of HM – can directly or indirectly affect the field. Dr. West calls it the hassle factor.

“You want to get a test in the hospital and, even though you’re the attending on the service, you end up going through three layers of bureaucracy with an insurance company to be able to finally get what you know that patient needs,” he said. “Anything like that contributes to the burnout problem because it pulls the physician away from what they want to be doing, what is purposeful, what is meaningful for them.”

For Dr. Yoon, the exhaustion and cynicism borne out by the work of Maslach and Dr. West’s team are measures indicative of a field where physicians struggle more and more to “make sense of why their practice is worthwhile.

“In the contemporary medical literature, we have been encouraged to adopt the concepts and practices of industrial engineering and quality improvement,” Dr. Yoon added. “In other words, it seems that to the extent physicians’ aspirations to practice good medicine are confined to the narrow and unimaginative constraints of mere scientific technique (more data, higher ‘quality,’ better outcomes) physicians will struggle to recognize and respond to their practice as meaningful. There is no intrinsic meaning to simply being a ‘cog’ in a medical-industrial process or an ‘independent variable’ in an economic equation.”

Finding meaning in one’s job, of course, is less empirical an endpoint than using a reversal agent for a GI bleed. Therein lies the challenge of battling burnout, whose causes and interventions can be as varied as the people who suffer the syndrome.

Local, customized solutions

Once a group leader identifies the symptoms of burnout, the obvious question is how to address it.

Dr. West and his colleagues have identified two broad categories of interventions: individual-focused approaches and organizational solutions. Physician-centered efforts include such tacks as mindfulness, stress reduction, resilience training and small-group communication. Institutional-level changes are, typically, much harder to implement and make successful.

“It doesn’t make sense to ... simply send physicians to stress-management training so that they’re better equipped to deal with a system that is not working to improve itself,” Dr. West said. “The system and the leadership in that system needs to take responsibility from an organizational standpoint.”

Health care as a whole has worked to address the systems-level issue. Duty-hour regulations have been reined in for trainees to be proactive in addressing both fatigue and its inevitable endpoint: burnout.

In a report, “Controlled Interventions to Reduce Burnout in Physicians: A Systematic Review and Meta-Analysis,”³ published online Dec. 5 in JAMA Internal Medicine, researchers concluded that interventions associated with small benefits “may be boosted by adoption of organization-directed approaches.

“This finding provides support for the view that burnout is a problem of the whole health care organization, rather than individuals,” they wrote.

But the issue typically remains a local one, as group leaders need to realize that what could cause or contribute to burnout in one employee might be enjoyable to another.

The silent epidemic

So if there are measurements for burnout, and even best practices on how to address it, why is the issue one that Dr. Mayer calls a silent epidemic? One word: stigma.

“We as physicians can’t afford to propagate that stigma any further,” Dr. Roberts said. “People who have even tougher jobs than we have, involving combat and hostage negotiation and things like that, have found a way to have honest conversations about the impact of their work on their lives. There is no reason physicians shouldn’t be able to slowly change the culture of medicine to be able to do that, so that there isn’t a stigma around saying, ‘I need some time away before this begins to impact the safety of our patients.’ ”

Dr. West said that when data show that as many as half of all physicians show symptoms of burnout, there is no need to stigmatize a group that large.

Dike Drummond, MD, a family physician, coach, and consultant on burnout prevention, said that the No. 1 mistake physicians and leaders make about burnout is labeling it a “problem.”

“Burnout does not have a single solution because it is not a problem to begin with,” he added. “Burnout is a classic dilemma – a never-ending balancing act. Think of the balancing act of burnout as a teeter-totter, like the one you see in a children’s playground. On one side is the energy you put into your practice and larger life … and on the other side your ability to recharge your energy levels.

“To prevent burnout you must keep your energy expenditure and your recharge activities in balance to keep this teeter-totter in a relatively horizontal position. And the way you address the dilemma is with a strategy: three to five individual tools you use to lower your stress levels or recharge your energy balance.”

And a strategy is a long-term approach to a long-term problem, he said.

“Burnout is not necessarily a terminal condition,” Dr. Roberts said. “If we can structure their work and the balance in their life in such a way that they don’t experience it, or that when they do experience it, they can recognize it and make the changes they need to avoid it getting worse, I think we’d be better off as a profession.”
 

Richard Quinn is a freelance writer in New Jersey.

References

1. Maslach C, Jackson S. The measurement of experienced burnout. J Occup Behavior. 1981;2:99-113

2. Roberts DL, Shanafelt TD, Dyrbye LN, West CP. A national comparison of burnout and work-life balance among internal medicine hospitalists and outpatient general internists. J Hosp Med. 2014;9(3):176-81.

3. Panagioti M, Panagopoulou E, Brower P. Controlled interventions to reduce burnout in physicians: a systematic review and meta-analysis [published online Dec. 5, 2016 ahead of print]. JAMA Intern Med. doi: 10.1001/jamainternmed.2016.7674.

Some 15 years ago, when Daniel Roberts, MD, FHM, decided at the end of his medical residency that his career path was going to be that of a hospitalist, he heard the same thing. A lot.

“Geesh, don’t you think you’re going to burn out?”

The reasons for such a response are well known in HM circles: the 7-on, 7-off shift structure; the constant rounding; the push-pull between clinical, administrative, and – what many would term – clerical work.

Darrin Klimek/Thinkstock

• Work effort.

• Work efficiency.

• Work-home interference.

• A sense of meaning.

• “Flexibility, control, and autonomy.”

Basically, the five drivers lead to this: Physicians who work too much and too inefficiently, with too little control and sense of purpose, end up flaming out more so than do doctors who work fewer hours, with fewer obstacles – all the while feeling satisfied with their autonomy and value.

Academic hospitalist John Yoon, MD, assistant professor of medicine at the University of Chicago, says that health care has to work harder to promote its benefits as being more important than a highly paid profession. Instead, health care should focus on giving meaning to its practitioners.

“I think it is time for leaders of HM groups to honestly discuss the intrinsic meaning and essential ‘calling’ of what it means to be a good hospitalist,” Dr. Yoon wrote in an email interview with The Hospitalist. “What can we do to make the hospitalist vocation a meaningful, long-term career, so that they do not feel like simply revenue-generating ‘pawns’ in a medical-bureaucratic system?”

A ‘meaningful’ career

The modern discussion of burnout as a phenomenon traces back to the Maslach Burnout Inventory, a three-pronged test that measures emotional exhaustion, depersonalization, and personal accomplishment.¹ But why does burnout hit physicians – hospitalists, in particular – so intensely? In part, it’s because – like their predecessors in emergency medicine – hospitalists are responsible for managing the care of patients other specialties consult with, operate on, or for whom they run tests.

“Once the patients come up from the emergency room or get admitted to the hospital from the outside, the hospitalist is the one who is largely running that show,” said Dr. West, whose researchshows that HM doctors suffer burnout more than the average across medical specialties.² “So they’re the front line of inpatient medicine.”

Another factor contributing to burnout’s impact on hospitalists is that the specialty’s rank and file (by definition) work within the walls of institutions that have a lot of contentious and complicated issues that – while outside the purview of HM – can directly or indirectly affect the field. Dr. West calls it the hassle factor.

“You want to get a test in the hospital and, even though you’re the attending on the service, you end up going through three layers of bureaucracy with an insurance company to be able to finally get what you know that patient needs,” he said. “Anything like that contributes to the burnout problem because it pulls the physician away from what they want to be doing, what is purposeful, what is meaningful for them.”

For Dr. Yoon, the exhaustion and cynicism borne out by the work of Maslach and Dr. West’s team are measures indicative of a field where physicians struggle more and more to “make sense of why their practice is worthwhile.

“In the contemporary medical literature, we have been encouraged to adopt the concepts and practices of industrial engineering and quality improvement,” Dr. Yoon added. “In other words, it seems that to the extent physicians’ aspirations to practice good medicine are confined to the narrow and unimaginative constraints of mere scientific technique (more data, higher ‘quality,’ better outcomes) physicians will struggle to recognize and respond to their practice as meaningful. There is no intrinsic meaning to simply being a ‘cog’ in a medical-industrial process or an ‘independent variable’ in an economic equation.”

Finding meaning in one’s job, of course, is less empirical an endpoint than using a reversal agent for a GI bleed. Therein lies the challenge of battling burnout, whose causes and interventions can be as varied as the people who suffer the syndrome.

Local, customized solutions

Once a group leader identifies the symptoms of burnout, the obvious question is how to address it.

Dr. West and his colleagues have identified two broad categories of interventions: individual-focused approaches and organizational solutions. Physician-centered efforts include such tacks as mindfulness, stress reduction, resilience training and small-group communication. Institutional-level changes are, typically, much harder to implement and make successful.

“It doesn’t make sense to ... simply send physicians to stress-management training so that they’re better equipped to deal with a system that is not working to improve itself,” Dr. West said. “The system and the leadership in that system needs to take responsibility from an organizational standpoint.”

Health care as a whole has worked to address the systems-level issue. Duty-hour regulations have been reined in for trainees to be proactive in addressing both fatigue and its inevitable endpoint: burnout.

In a report, “Controlled Interventions to Reduce Burnout in Physicians: A Systematic Review and Meta-Analysis,”³ published online Dec. 5 in JAMA Internal Medicine, researchers concluded that interventions associated with small benefits “may be boosted by adoption of organization-directed approaches.

“This finding provides support for the view that burnout is a problem of the whole health care organization, rather than individuals,” they wrote.

But the issue typically remains a local one, as group leaders need to realize that what could cause or contribute to burnout in one employee might be enjoyable to another.

The silent epidemic

So if there are measurements for burnout, and even best practices on how to address it, why is the issue one that Dr. Mayer calls a silent epidemic? One word: stigma.

“We as physicians can’t afford to propagate that stigma any further,” Dr. Roberts said. “People who have even tougher jobs than we have, involving combat and hostage negotiation and things like that, have found a way to have honest conversations about the impact of their work on their lives. There is no reason physicians shouldn’t be able to slowly change the culture of medicine to be able to do that, so that there isn’t a stigma around saying, ‘I need some time away before this begins to impact the safety of our patients.’ ”

Dr. West said that when data show that as many as half of all physicians show symptoms of burnout, there is no need to stigmatize a group that large.

Dike Drummond, MD, a family physician, coach, and consultant on burnout prevention, said that the No. 1 mistake physicians and leaders make about burnout is labeling it a “problem.”

“Burnout does not have a single solution because it is not a problem to begin with,” he added. “Burnout is a classic dilemma – a never-ending balancing act. Think of the balancing act of burnout as a teeter-totter, like the one you see in a children’s playground. On one side is the energy you put into your practice and larger life … and on the other side your ability to recharge your energy levels.

“To prevent burnout you must keep your energy expenditure and your recharge activities in balance to keep this teeter-totter in a relatively horizontal position. And the way you address the dilemma is with a strategy: three to five individual tools you use to lower your stress levels or recharge your energy balance.”

And a strategy is a long-term approach to a long-term problem, he said.

“Burnout is not necessarily a terminal condition,” Dr. Roberts said. “If we can structure their work and the balance in their life in such a way that they don’t experience it, or that when they do experience it, they can recognize it and make the changes they need to avoid it getting worse, I think we’d be better off as a profession.”
 

Richard Quinn is a freelance writer in New Jersey.

References

1. Maslach C, Jackson S. The measurement of experienced burnout. J Occup Behavior. 1981;2:99-113

2. Roberts DL, Shanafelt TD, Dyrbye LN, West CP. A national comparison of burnout and work-life balance among internal medicine hospitalists and outpatient general internists. J Hosp Med. 2014;9(3):176-81.

3. Panagioti M, Panagopoulou E, Brower P. Controlled interventions to reduce burnout in physicians: a systematic review and meta-analysis [published online Dec. 5, 2016 ahead of print]. JAMA Intern Med. doi: 10.1001/jamainternmed.2016.7674.

Some 15 years ago, when Daniel Roberts, MD, FHM, decided at the end of his medical residency that his career path was going to be that of a hospitalist, he heard the same thing. A lot.

“Geesh, don’t you think you’re going to burn out?”

The reasons for such a response are well known in HM circles: the 7-on, 7-off shift structure; the constant rounding; the push-pull between clinical, administrative, and – what many would term – clerical work.

Darrin Klimek/Thinkstock

• Work effort.

• Work efficiency.

• Work-home interference.

• A sense of meaning.

• “Flexibility, control, and autonomy.”

Basically, the five drivers lead to this: Physicians who work too much and too inefficiently, with too little control and sense of purpose, end up flaming out more so than do doctors who work fewer hours, with fewer obstacles – all the while feeling satisfied with their autonomy and value.

Academic hospitalist John Yoon, MD, assistant professor of medicine at the University of Chicago, says that health care has to work harder to promote its benefits as being more important than a highly paid profession. Instead, health care should focus on giving meaning to its practitioners.

“I think it is time for leaders of HM groups to honestly discuss the intrinsic meaning and essential ‘calling’ of what it means to be a good hospitalist,” Dr. Yoon wrote in an email interview with The Hospitalist. “What can we do to make the hospitalist vocation a meaningful, long-term career, so that they do not feel like simply revenue-generating ‘pawns’ in a medical-bureaucratic system?”

A ‘meaningful’ career

The modern discussion of burnout as a phenomenon traces back to the Maslach Burnout Inventory, a three-pronged test that measures emotional exhaustion, depersonalization, and personal accomplishment.¹ But why does burnout hit physicians – hospitalists, in particular – so intensely? In part, it’s because – like their predecessors in emergency medicine – hospitalists are responsible for managing the care of patients other specialties consult with, operate on, or for whom they run tests.

“Once the patients come up from the emergency room or get admitted to the hospital from the outside, the hospitalist is the one who is largely running that show,” said Dr. West, whose researchshows that HM doctors suffer burnout more than the average across medical specialties.² “So they’re the front line of inpatient medicine.”

Another factor contributing to burnout’s impact on hospitalists is that the specialty’s rank and file (by definition) work within the walls of institutions that have a lot of contentious and complicated issues that – while outside the purview of HM – can directly or indirectly affect the field. Dr. West calls it the hassle factor.

“You want to get a test in the hospital and, even though you’re the attending on the service, you end up going through three layers of bureaucracy with an insurance company to be able to finally get what you know that patient needs,” he said. “Anything like that contributes to the burnout problem because it pulls the physician away from what they want to be doing, what is purposeful, what is meaningful for them.”

For Dr. Yoon, the exhaustion and cynicism borne out by the work of Maslach and Dr. West’s team are measures indicative of a field where physicians struggle more and more to “make sense of why their practice is worthwhile.

“In the contemporary medical literature, we have been encouraged to adopt the concepts and practices of industrial engineering and quality improvement,” Dr. Yoon added. “In other words, it seems that to the extent physicians’ aspirations to practice good medicine are confined to the narrow and unimaginative constraints of mere scientific technique (more data, higher ‘quality,’ better outcomes) physicians will struggle to recognize and respond to their practice as meaningful. There is no intrinsic meaning to simply being a ‘cog’ in a medical-industrial process or an ‘independent variable’ in an economic equation.”

Finding meaning in one’s job, of course, is less empirical an endpoint than using a reversal agent for a GI bleed. Therein lies the challenge of battling burnout, whose causes and interventions can be as varied as the people who suffer the syndrome.

Local, customized solutions

Once a group leader identifies the symptoms of burnout, the obvious question is how to address it.

Dr. West and his colleagues have identified two broad categories of interventions: individual-focused approaches and organizational solutions. Physician-centered efforts include such tacks as mindfulness, stress reduction, resilience training and small-group communication. Institutional-level changes are, typically, much harder to implement and make successful.

“It doesn’t make sense to ... simply send physicians to stress-management training so that they’re better equipped to deal with a system that is not working to improve itself,” Dr. West said. “The system and the leadership in that system needs to take responsibility from an organizational standpoint.”

Health care as a whole has worked to address the systems-level issue. Duty-hour regulations have been reined in for trainees to be proactive in addressing both fatigue and its inevitable endpoint: burnout.

In a report, “Controlled Interventions to Reduce Burnout in Physicians: A Systematic Review and Meta-Analysis,”³ published online Dec. 5 in JAMA Internal Medicine, researchers concluded that interventions associated with small benefits “may be boosted by adoption of organization-directed approaches.

“This finding provides support for the view that burnout is a problem of the whole health care organization, rather than individuals,” they wrote.

But the issue typically remains a local one, as group leaders need to realize that what could cause or contribute to burnout in one employee might be enjoyable to another.

The silent epidemic

So if there are measurements for burnout, and even best practices on how to address it, why is the issue one that Dr. Mayer calls a silent epidemic? One word: stigma.

“We as physicians can’t afford to propagate that stigma any further,” Dr. Roberts said. “People who have even tougher jobs than we have, involving combat and hostage negotiation and things like that, have found a way to have honest conversations about the impact of their work on their lives. There is no reason physicians shouldn’t be able to slowly change the culture of medicine to be able to do that, so that there isn’t a stigma around saying, ‘I need some time away before this begins to impact the safety of our patients.’ ”

Dr. West said that when data show that as many as half of all physicians show symptoms of burnout, there is no need to stigmatize a group that large.

Dike Drummond, MD, a family physician, coach, and consultant on burnout prevention, said that the No. 1 mistake physicians and leaders make about burnout is labeling it a “problem.”

“Burnout does not have a single solution because it is not a problem to begin with,” he added. “Burnout is a classic dilemma – a never-ending balancing act. Think of the balancing act of burnout as a teeter-totter, like the one you see in a children’s playground. On one side is the energy you put into your practice and larger life … and on the other side your ability to recharge your energy levels.

“To prevent burnout you must keep your energy expenditure and your recharge activities in balance to keep this teeter-totter in a relatively horizontal position. And the way you address the dilemma is with a strategy: three to five individual tools you use to lower your stress levels or recharge your energy balance.”

And a strategy is a long-term approach to a long-term problem, he said.

“Burnout is not necessarily a terminal condition,” Dr. Roberts said. “If we can structure their work and the balance in their life in such a way that they don’t experience it, or that when they do experience it, they can recognize it and make the changes they need to avoid it getting worse, I think we’d be better off as a profession.”
 

Richard Quinn is a freelance writer in New Jersey.

References

1. Maslach C, Jackson S. The measurement of experienced burnout. J Occup Behavior. 1981;2:99-113

2. Roberts DL, Shanafelt TD, Dyrbye LN, West CP. A national comparison of burnout and work-life balance among internal medicine hospitalists and outpatient general internists. J Hosp Med. 2014;9(3):176-81.

3. Panagioti M, Panagopoulou E, Brower P. Controlled interventions to reduce burnout in physicians: a systematic review and meta-analysis [published online Dec. 5, 2016 ahead of print]. JAMA Intern Med. doi: 10.1001/jamainternmed.2016.7674.

Arguably, the introduction of the birth control pill has transformed female health more than any other drug in modern medicine. Although many of us practicing now do not know life without it, its history is not that long.

“The Pill” – as it is often referred to – was introduced in May of 1950.¹ At that time, prevention of pregnancy was not listed as an indication, and promoting birth control was politically, socially, and legally unacceptable. In fact, the Comstock Law prohibited public discussion and research about contraception.¹ Therefore, when the birth control pill was introduced, it was for cycle control and for married women only. It was not indicated for use as contraception in the United States until 1960.

Since that time, the birth control pill has evolved dramatically, not only in its formulation but in its indications as well. As pediatricians, we do not always find it easy to discuss with parents hormonal regulation and starting a patient on the birth control pill, particularly when it will not be used for contraception. There are many fears about using hormonal control, but there are many useful indications that improve the health and well-being of the pediatric patient.

Menorrhagia and dysmenorrhea are likely the most common reasons that hormonal therapy is started in adolescence. Beginning with the lowest estrogen dose to reduce side effects is prudent, adjusting accordingly if side effects should occur. Breakthrough bleeding is a common side effect that usually improves over time. Patients should continue treatment for at least 3 months before deciding if treatment is effective or not. If breakthrough bleeding continues, increasing the estrogen component or changing to a triphasic pill might reduce bleeding.

©areeya_ann/Thinkstock.com

References

1. Can Fam Physician. 2012 Dec;58(12):e757–60.

2. J Midwifery Womens Health. 2012 Nov-Dec;57(6):585-92.

3. Obstet Gynecol. 2009;114:1428-31.

4. Semin Cutan Med Surg. 2008 Sep;27(3):188-96.

5. Pediatr Rev. 2008;29(11);386-97.

6. J Eur Acad Dermatol Venereol. 2005 Mar;19(2):163-6.

7. Obstet Gynecol. 2005 Sep;106(3):492-501.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures.

Arguably, the introduction of the birth control pill has transformed female health more than any other drug in modern medicine. Although many of us practicing now do not know life without it, its history is not that long.

“The Pill” – as it is often referred to – was introduced in May of 1950.¹ At that time, prevention of pregnancy was not listed as an indication, and promoting birth control was politically, socially, and legally unacceptable. In fact, the Comstock Law prohibited public discussion and research about contraception.¹ Therefore, when the birth control pill was introduced, it was for cycle control and for married women only. It was not indicated for use as contraception in the United States until 1960.

Since that time, the birth control pill has evolved dramatically, not only in its formulation but in its indications as well. As pediatricians, we do not always find it easy to discuss with parents hormonal regulation and starting a patient on the birth control pill, particularly when it will not be used for contraception. There are many fears about using hormonal control, but there are many useful indications that improve the health and well-being of the pediatric patient.

Menorrhagia and dysmenorrhea are likely the most common reasons that hormonal therapy is started in adolescence. Beginning with the lowest estrogen dose to reduce side effects is prudent, adjusting accordingly if side effects should occur. Breakthrough bleeding is a common side effect that usually improves over time. Patients should continue treatment for at least 3 months before deciding if treatment is effective or not. If breakthrough bleeding continues, increasing the estrogen component or changing to a triphasic pill might reduce bleeding.

©areeya_ann/Thinkstock.com

References

1. Can Fam Physician. 2012 Dec;58(12):e757–60.

2. J Midwifery Womens Health. 2012 Nov-Dec;57(6):585-92.

3. Obstet Gynecol. 2009;114:1428-31.

4. Semin Cutan Med Surg. 2008 Sep;27(3):188-96.

5. Pediatr Rev. 2008;29(11);386-97.

6. J Eur Acad Dermatol Venereol. 2005 Mar;19(2):163-6.

7. Obstet Gynecol. 2005 Sep;106(3):492-501.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures.

Arguably, the introduction of the birth control pill has transformed female health more than any other drug in modern medicine. Although many of us practicing now do not know life without it, its history is not that long.

“The Pill” – as it is often referred to – was introduced in May of 1950.¹ At that time, prevention of pregnancy was not listed as an indication, and promoting birth control was politically, socially, and legally unacceptable. In fact, the Comstock Law prohibited public discussion and research about contraception.¹ Therefore, when the birth control pill was introduced, it was for cycle control and for married women only. It was not indicated for use as contraception in the United States until 1960.

Since that time, the birth control pill has evolved dramatically, not only in its formulation but in its indications as well. As pediatricians, we do not always find it easy to discuss with parents hormonal regulation and starting a patient on the birth control pill, particularly when it will not be used for contraception. There are many fears about using hormonal control, but there are many useful indications that improve the health and well-being of the pediatric patient.

Menorrhagia and dysmenorrhea are likely the most common reasons that hormonal therapy is started in adolescence. Beginning with the lowest estrogen dose to reduce side effects is prudent, adjusting accordingly if side effects should occur. Breakthrough bleeding is a common side effect that usually improves over time. Patients should continue treatment for at least 3 months before deciding if treatment is effective or not. If breakthrough bleeding continues, increasing the estrogen component or changing to a triphasic pill might reduce bleeding.

©areeya_ann/Thinkstock.com

References

1. Can Fam Physician. 2012 Dec;58(12):e757–60.

2. J Midwifery Womens Health. 2012 Nov-Dec;57(6):585-92.

3. Obstet Gynecol. 2009;114:1428-31.

4. Semin Cutan Med Surg. 2008 Sep;27(3):188-96.

5. Pediatr Rev. 2008;29(11);386-97.

6. J Eur Acad Dermatol Venereol. 2005 Mar;19(2):163-6.

7. Obstet Gynecol. 2005 Sep;106(3):492-501.

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures.

CHICAGO – Five years after the Society for Vascular Surgery launched the Vascular Quality Initiative, participating centers are more likely to use chlorhexidine and have also cut their surgery times and reduced their transfusion rates, according to results presented at a symposium on vascular surgery sponsored by Northwestern University.

But more drastic have been the improvements once low-performing centers have made in these measures and others, Larry Kraiss, MD, of the University of Utah, Salt Lake City, said in reporting an update on VQI. “If you look at centers that had a big change in not using chlorhexidine to using chlorhexidine, the reduction of surgical site infections [SSI] in that subgroup was actually pretty significant,” said Dr. Kraiss, chair of the governing council of the SVS Patient Safety Organization, which oversees VQI.

CHICAGO – Five years after the Society for Vascular Surgery launched the Vascular Quality Initiative, participating centers are more likely to use chlorhexidine and have also cut their surgery times and reduced their transfusion rates, according to results presented at a symposium on vascular surgery sponsored by Northwestern University.

But more drastic have been the improvements once low-performing centers have made in these measures and others, Larry Kraiss, MD, of the University of Utah, Salt Lake City, said in reporting an update on VQI. “If you look at centers that had a big change in not using chlorhexidine to using chlorhexidine, the reduction of surgical site infections [SSI] in that subgroup was actually pretty significant,” said Dr. Kraiss, chair of the governing council of the SVS Patient Safety Organization, which oversees VQI.

CHICAGO – Five years after the Society for Vascular Surgery launched the Vascular Quality Initiative, participating centers are more likely to use chlorhexidine and have also cut their surgery times and reduced their transfusion rates, according to results presented at a symposium on vascular surgery sponsored by Northwestern University.

But more drastic have been the improvements once low-performing centers have made in these measures and others, Larry Kraiss, MD, of the University of Utah, Salt Lake City, said in reporting an update on VQI. “If you look at centers that had a big change in not using chlorhexidine to using chlorhexidine, the reduction of surgical site infections [SSI] in that subgroup was actually pretty significant,” said Dr. Kraiss, chair of the governing council of the SVS Patient Safety Organization, which oversees VQI.

Take-Home Points

• RTSA is projected to triple by 2020.
• RTSA for fracture indication anticipates a 4.9% compound quarterly growth rate.

• RTSA is gaining in popularity likely due to unpredictable results of hemiarthroplasty in select patients.

Reverse total shoulder arthroplasty (RTSA) is an accepted treatment option for the pain and dysfunction associated with glenohumeral arthritis and severe rotator cuff pathology.^1-3 Recently, it has been gaining acceptance as an alternative to hemiarthroplasty (HA) and open reduction and internal fixation (ORIF) in the surgical management of complex proximal humerus fractures (PHFs) in elderly patients.^4-6 The advantages of RTSA over other PHF treatment options include a lower revision rate and superior range of motion.^4,5

PHF remains one of the most common fracture pathologies in the United States.⁷ Given the country’s aging patient population, the popularity of RTSA likely will continue to increase.^4-6 The release of supercomputer data from individual private-payer insurance providers provides an opportunity to investigate trends in the surgical management of PHFs and to formulate models for predicting use. In this study, we used a large private-payer database to analyze these trends over the period 2010 to 2014 and project RTSA use through 2020.

Methods

We used PearlDiver’s supercomputer application to search the Humana private-payer database to retrospectively identify cases of PHF treated with the index procedure of RTSA. PearlDiver, a publicly available national database compliant with HIPAA (Health Insurance Portability and Accountability Act of 1996), compiles private-payer records submitted by Humana. These records represent 100% of the orthopedics-related payer records within the dataset. The database includes International Classification of Diseases, Ninth Revision (ICD-9) codes and Current Procedural Terminology (CPT) codes from 2007 to 2014.

RTSA cases were identified by ICD-9 codes 81.80 and 81.88 and CPT code 23472. PHFs were identified by ICD-9, Clinical Modification (ICD-9-CM) codes 812.00, 812.01, 812.02, 812.03, 812.09, 812.10, 812.11, 812.12, 812.13, 812.19, and 812.20. Holt-Winters quarterly (Q) projection analysis was performed on the RTSA-PHF data from Q1-2010 through Q4-2020 (Figure).

Results

For the known study period Q1-2010 through Q3-2014, our search yielded 46,106 PHF cases, 4057 (8.8%) of which were surgically treated with RTSAs (Table 1).

Age-based subgroup analysis revealed RTSA was performed primarily in the older-than-65 years patient population, with the highest percentage in the 70-to-74 years age group (24.4%), followed by the 75-to-79 years age group (21.6%) (Table 2).

Discussion

Use of RTSA for the management of complex PHFs has increased tremendously over the past several years. The primary results of our study showed an upward trend in RTSA use in the Humana population. CQGR was 6.5% from Q1-2010 through Q3-2014 (the number of RTSAs increased to 294 from 95). Based on the Holt-Winters projection analysis, CQGR was projected to be 2.8% through 2020 (339 RTSAs in Q4-2014 increasing to 664 RTSAs in Q4-2020), resulting in an overall 10-year CQGR of 4.6%.

Recent studies have shown RTSA to be a viable alternative to HA in patients with PHFs. It has been suggested that RTSAs may have more reliable clinical outcomes without a comparative increase in complication rates.^1,8,9 HA has been associated with unpredictable motion, higher complication rates, and high rates of unsatisfactory results in patients older than 65 years.^10-12 In addition, studies have found that, compared with HA and ORIF, RTSA produces superior range of motion.^8,9 The reliability of clinical outcomes in the early transition to use of RTSA for complex fractures suggests that use of RTSA for PHF management is trending upward. Results of the present study showed a steady increase in RTSA use. This trend is further supported by a recent study finding on national trends in RTSA use in PHF cases: 12.3% annual growth during the period 2000 to 2008.⁶Our study results showed a continued steady quarterly increase in use of RTSA for PHFs, projected to triple by Q4-2020 (Table 1). The increasing popularity of RTSA may be attributable to its better clinical outcomes and to the procedural instruction given to newly trained orthopedic surgeons during residency. A recent study found a substantial increase in the use of RTSA for PHFs—from 2% in 2005 to 38% in 2012—among newly trained orthopedic surgeons.¹³ Another possible driver of the increase is cost. Although RTSA implant costs are often a multiple of the costs of other treatment options, different findings were reported in 2 recent studies that used quality-adjusted life-years (QALY) to determine RTSA cost-effectiveness. Coe and colleagues¹⁴ compared RTSA with HA and found RTSA to be cost-effective but highly dependent on implant cost. They determined that an implant cost of over $13,000 put RTSA cost-effectiveness at just under $100,000 QALY, whereas an implant cost of under $7000 brought QALY down to under $50,000. Renfree and colleagues¹⁵ used the same QALY benchmark but found RTSA to be at the highly cost-effective threshold of under $25,000 QALY.

Current literature recommends RTSA be performed primarily for elderly patients.^1,2,16,17 Guery and colleagues² suggested limiting RTSA to patients who are older than 70 years and have low functional demands. In 2 studies of RTSA use in complex humeral fractures, Gallinet and colleagues^16,18 found an increased rate of scapular notching in younger patients and recommended restricting RTSA to patients 70 years or older. PHFs in patients older than 70 years often have more complex fracture patterns and poor-quality bone, which makes fracture healing more challenging in HA and ORIF settings. As tuberosity healing is crucial to functional outcomes of surgically treated PHFs, RTSA has been advanced as a more reliable option in patients in whom tuberosity healing is expected to be unreliable. The present study’s finding that 68.5% of the RTSA patients in the Humana population were older than 70 years further supports the literature’s emphasis on reserving RTSA for patients over 70 years.

This study had its limitations. The PearlDiver database depends on accurate ICD-9 and CPT coding, and there was potential for reporting bias. In addition, a new, specific ICD-9 code for RTSA was introduced in 2010 and may not have been immediately used; data reported during this time could have been affected. Furthermore, the data were primarily represented by a single private-payer organization (Humana) and therefore may not have fully encapsulated the entire US trend. Projection in this study did not account for US Census–predicted population growth and therefore may have underestimated the true projected use of RTSA for PHFs.

This study benefited from the completeness of the data used. PearlDiver represents 100% of Humana claims data, providing a large patient population for analysis and capturing data as recent as 2014. To our knowledge, no other large database studies have used such up-to-date data.

Conclusion

RTSA is becoming an increasingly popular treatment option for PHFs. Modest overall quarterly growth in use of RTSA for PHFs (CQGR, 4.6%) is predicted through Q4-2020. Number of RTSAs performed for PHF management is projected to more than triple by 2020.

Am J Orthop. 2017;46(1):E28-E31. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• RTSA is projected to triple by 2020.
• RTSA for fracture indication anticipates a 4.9% compound quarterly growth rate.

• RTSA is gaining in popularity likely due to unpredictable results of hemiarthroplasty in select patients.

Reverse total shoulder arthroplasty (RTSA) is an accepted treatment option for the pain and dysfunction associated with glenohumeral arthritis and severe rotator cuff pathology.^1-3 Recently, it has been gaining acceptance as an alternative to hemiarthroplasty (HA) and open reduction and internal fixation (ORIF) in the surgical management of complex proximal humerus fractures (PHFs) in elderly patients.^4-6 The advantages of RTSA over other PHF treatment options include a lower revision rate and superior range of motion.^4,5

PHF remains one of the most common fracture pathologies in the United States.⁷ Given the country’s aging patient population, the popularity of RTSA likely will continue to increase.^4-6 The release of supercomputer data from individual private-payer insurance providers provides an opportunity to investigate trends in the surgical management of PHFs and to formulate models for predicting use. In this study, we used a large private-payer database to analyze these trends over the period 2010 to 2014 and project RTSA use through 2020.

Methods

We used PearlDiver’s supercomputer application to search the Humana private-payer database to retrospectively identify cases of PHF treated with the index procedure of RTSA. PearlDiver, a publicly available national database compliant with HIPAA (Health Insurance Portability and Accountability Act of 1996), compiles private-payer records submitted by Humana. These records represent 100% of the orthopedics-related payer records within the dataset. The database includes International Classification of Diseases, Ninth Revision (ICD-9) codes and Current Procedural Terminology (CPT) codes from 2007 to 2014.

RTSA cases were identified by ICD-9 codes 81.80 and 81.88 and CPT code 23472. PHFs were identified by ICD-9, Clinical Modification (ICD-9-CM) codes 812.00, 812.01, 812.02, 812.03, 812.09, 812.10, 812.11, 812.12, 812.13, 812.19, and 812.20. Holt-Winters quarterly (Q) projection analysis was performed on the RTSA-PHF data from Q1-2010 through Q4-2020 (Figure).

Results

For the known study period Q1-2010 through Q3-2014, our search yielded 46,106 PHF cases, 4057 (8.8%) of which were surgically treated with RTSAs (Table 1).

Age-based subgroup analysis revealed RTSA was performed primarily in the older-than-65 years patient population, with the highest percentage in the 70-to-74 years age group (24.4%), followed by the 75-to-79 years age group (21.6%) (Table 2).

Discussion

Use of RTSA for the management of complex PHFs has increased tremendously over the past several years. The primary results of our study showed an upward trend in RTSA use in the Humana population. CQGR was 6.5% from Q1-2010 through Q3-2014 (the number of RTSAs increased to 294 from 95). Based on the Holt-Winters projection analysis, CQGR was projected to be 2.8% through 2020 (339 RTSAs in Q4-2014 increasing to 664 RTSAs in Q4-2020), resulting in an overall 10-year CQGR of 4.6%.

Recent studies have shown RTSA to be a viable alternative to HA in patients with PHFs. It has been suggested that RTSAs may have more reliable clinical outcomes without a comparative increase in complication rates.^1,8,9 HA has been associated with unpredictable motion, higher complication rates, and high rates of unsatisfactory results in patients older than 65 years.^10-12 In addition, studies have found that, compared with HA and ORIF, RTSA produces superior range of motion.^8,9 The reliability of clinical outcomes in the early transition to use of RTSA for complex fractures suggests that use of RTSA for PHF management is trending upward. Results of the present study showed a steady increase in RTSA use. This trend is further supported by a recent study finding on national trends in RTSA use in PHF cases: 12.3% annual growth during the period 2000 to 2008.⁶Our study results showed a continued steady quarterly increase in use of RTSA for PHFs, projected to triple by Q4-2020 (Table 1). The increasing popularity of RTSA may be attributable to its better clinical outcomes and to the procedural instruction given to newly trained orthopedic surgeons during residency. A recent study found a substantial increase in the use of RTSA for PHFs—from 2% in 2005 to 38% in 2012—among newly trained orthopedic surgeons.¹³ Another possible driver of the increase is cost. Although RTSA implant costs are often a multiple of the costs of other treatment options, different findings were reported in 2 recent studies that used quality-adjusted life-years (QALY) to determine RTSA cost-effectiveness. Coe and colleagues¹⁴ compared RTSA with HA and found RTSA to be cost-effective but highly dependent on implant cost. They determined that an implant cost of over $13,000 put RTSA cost-effectiveness at just under $100,000 QALY, whereas an implant cost of under $7000 brought QALY down to under $50,000. Renfree and colleagues¹⁵ used the same QALY benchmark but found RTSA to be at the highly cost-effective threshold of under $25,000 QALY.

Current literature recommends RTSA be performed primarily for elderly patients.^1,2,16,17 Guery and colleagues² suggested limiting RTSA to patients who are older than 70 years and have low functional demands. In 2 studies of RTSA use in complex humeral fractures, Gallinet and colleagues^16,18 found an increased rate of scapular notching in younger patients and recommended restricting RTSA to patients 70 years or older. PHFs in patients older than 70 years often have more complex fracture patterns and poor-quality bone, which makes fracture healing more challenging in HA and ORIF settings. As tuberosity healing is crucial to functional outcomes of surgically treated PHFs, RTSA has been advanced as a more reliable option in patients in whom tuberosity healing is expected to be unreliable. The present study’s finding that 68.5% of the RTSA patients in the Humana population were older than 70 years further supports the literature’s emphasis on reserving RTSA for patients over 70 years.

This study had its limitations. The PearlDiver database depends on accurate ICD-9 and CPT coding, and there was potential for reporting bias. In addition, a new, specific ICD-9 code for RTSA was introduced in 2010 and may not have been immediately used; data reported during this time could have been affected. Furthermore, the data were primarily represented by a single private-payer organization (Humana) and therefore may not have fully encapsulated the entire US trend. Projection in this study did not account for US Census–predicted population growth and therefore may have underestimated the true projected use of RTSA for PHFs.

This study benefited from the completeness of the data used. PearlDiver represents 100% of Humana claims data, providing a large patient population for analysis and capturing data as recent as 2014. To our knowledge, no other large database studies have used such up-to-date data.

Conclusion

RTSA is becoming an increasingly popular treatment option for PHFs. Modest overall quarterly growth in use of RTSA for PHFs (CQGR, 4.6%) is predicted through Q4-2020. Number of RTSAs performed for PHF management is projected to more than triple by 2020.

Am J Orthop. 2017;46(1):E28-E31. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• RTSA is projected to triple by 2020.
• RTSA for fracture indication anticipates a 4.9% compound quarterly growth rate.

• RTSA is gaining in popularity likely due to unpredictable results of hemiarthroplasty in select patients.

Reverse total shoulder arthroplasty (RTSA) is an accepted treatment option for the pain and dysfunction associated with glenohumeral arthritis and severe rotator cuff pathology.^1-3 Recently, it has been gaining acceptance as an alternative to hemiarthroplasty (HA) and open reduction and internal fixation (ORIF) in the surgical management of complex proximal humerus fractures (PHFs) in elderly patients.^4-6 The advantages of RTSA over other PHF treatment options include a lower revision rate and superior range of motion.^4,5

PHF remains one of the most common fracture pathologies in the United States.⁷ Given the country’s aging patient population, the popularity of RTSA likely will continue to increase.^4-6 The release of supercomputer data from individual private-payer insurance providers provides an opportunity to investigate trends in the surgical management of PHFs and to formulate models for predicting use. In this study, we used a large private-payer database to analyze these trends over the period 2010 to 2014 and project RTSA use through 2020.

Methods

We used PearlDiver’s supercomputer application to search the Humana private-payer database to retrospectively identify cases of PHF treated with the index procedure of RTSA. PearlDiver, a publicly available national database compliant with HIPAA (Health Insurance Portability and Accountability Act of 1996), compiles private-payer records submitted by Humana. These records represent 100% of the orthopedics-related payer records within the dataset. The database includes International Classification of Diseases, Ninth Revision (ICD-9) codes and Current Procedural Terminology (CPT) codes from 2007 to 2014.

RTSA cases were identified by ICD-9 codes 81.80 and 81.88 and CPT code 23472. PHFs were identified by ICD-9, Clinical Modification (ICD-9-CM) codes 812.00, 812.01, 812.02, 812.03, 812.09, 812.10, 812.11, 812.12, 812.13, 812.19, and 812.20. Holt-Winters quarterly (Q) projection analysis was performed on the RTSA-PHF data from Q1-2010 through Q4-2020 (Figure).

Results

For the known study period Q1-2010 through Q3-2014, our search yielded 46,106 PHF cases, 4057 (8.8%) of which were surgically treated with RTSAs (Table 1).

Age-based subgroup analysis revealed RTSA was performed primarily in the older-than-65 years patient population, with the highest percentage in the 70-to-74 years age group (24.4%), followed by the 75-to-79 years age group (21.6%) (Table 2).

Discussion

Use of RTSA for the management of complex PHFs has increased tremendously over the past several years. The primary results of our study showed an upward trend in RTSA use in the Humana population. CQGR was 6.5% from Q1-2010 through Q3-2014 (the number of RTSAs increased to 294 from 95). Based on the Holt-Winters projection analysis, CQGR was projected to be 2.8% through 2020 (339 RTSAs in Q4-2014 increasing to 664 RTSAs in Q4-2020), resulting in an overall 10-year CQGR of 4.6%.

Recent studies have shown RTSA to be a viable alternative to HA in patients with PHFs. It has been suggested that RTSAs may have more reliable clinical outcomes without a comparative increase in complication rates.^1,8,9 HA has been associated with unpredictable motion, higher complication rates, and high rates of unsatisfactory results in patients older than 65 years.^10-12 In addition, studies have found that, compared with HA and ORIF, RTSA produces superior range of motion.^8,9 The reliability of clinical outcomes in the early transition to use of RTSA for complex fractures suggests that use of RTSA for PHF management is trending upward. Results of the present study showed a steady increase in RTSA use. This trend is further supported by a recent study finding on national trends in RTSA use in PHF cases: 12.3% annual growth during the period 2000 to 2008.⁶Our study results showed a continued steady quarterly increase in use of RTSA for PHFs, projected to triple by Q4-2020 (Table 1). The increasing popularity of RTSA may be attributable to its better clinical outcomes and to the procedural instruction given to newly trained orthopedic surgeons during residency. A recent study found a substantial increase in the use of RTSA for PHFs—from 2% in 2005 to 38% in 2012—among newly trained orthopedic surgeons.¹³ Another possible driver of the increase is cost. Although RTSA implant costs are often a multiple of the costs of other treatment options, different findings were reported in 2 recent studies that used quality-adjusted life-years (QALY) to determine RTSA cost-effectiveness. Coe and colleagues¹⁴ compared RTSA with HA and found RTSA to be cost-effective but highly dependent on implant cost. They determined that an implant cost of over $13,000 put RTSA cost-effectiveness at just under $100,000 QALY, whereas an implant cost of under $7000 brought QALY down to under $50,000. Renfree and colleagues¹⁵ used the same QALY benchmark but found RTSA to be at the highly cost-effective threshold of under $25,000 QALY.

Current literature recommends RTSA be performed primarily for elderly patients.^1,2,16,17 Guery and colleagues² suggested limiting RTSA to patients who are older than 70 years and have low functional demands. In 2 studies of RTSA use in complex humeral fractures, Gallinet and colleagues^16,18 found an increased rate of scapular notching in younger patients and recommended restricting RTSA to patients 70 years or older. PHFs in patients older than 70 years often have more complex fracture patterns and poor-quality bone, which makes fracture healing more challenging in HA and ORIF settings. As tuberosity healing is crucial to functional outcomes of surgically treated PHFs, RTSA has been advanced as a more reliable option in patients in whom tuberosity healing is expected to be unreliable. The present study’s finding that 68.5% of the RTSA patients in the Humana population were older than 70 years further supports the literature’s emphasis on reserving RTSA for patients over 70 years.

This study had its limitations. The PearlDiver database depends on accurate ICD-9 and CPT coding, and there was potential for reporting bias. In addition, a new, specific ICD-9 code for RTSA was introduced in 2010 and may not have been immediately used; data reported during this time could have been affected. Furthermore, the data were primarily represented by a single private-payer organization (Humana) and therefore may not have fully encapsulated the entire US trend. Projection in this study did not account for US Census–predicted population growth and therefore may have underestimated the true projected use of RTSA for PHFs.

This study benefited from the completeness of the data used. PearlDiver represents 100% of Humana claims data, providing a large patient population for analysis and capturing data as recent as 2014. To our knowledge, no other large database studies have used such up-to-date data.

Conclusion

RTSA is becoming an increasingly popular treatment option for PHFs. Modest overall quarterly growth in use of RTSA for PHFs (CQGR, 4.6%) is predicted through Q4-2020. Number of RTSAs performed for PHF management is projected to more than triple by 2020.

Am J Orthop. 2017;46(1):E28-E31. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

AMSTERDAM – Axillary radiotherapy appears to be a safe and effective alternative to completion axillary lymph node dissection (cALND) for selected patients who have early invasive breast cancer with sentinel lymph node metastasis, a randomized phase III trial showed.

After a mean of just over 8 years of follow-up, there were no significant differences in breast cancer recurrence, overall survival (OS), disease-free survival (DFS), or breast cancer deaths between patients treated with cALND or axillary radiotherapy, reported Akos Savolt, MD, PhD, of the National Institute of Oncology in Budapest.

“This trial has changed our everyday practice about the optimal care of the axilla,” he said at an annual congress sponsored by the European Cancer Organisation.

An estimated 25%-50% of patients with positive sentinel lymph nodes will have disease that extends to other lymph nodes, and for these patients, cALND is the standard of care.

But patients for whom metastasis is limited to the sentinel lymph node are unlikely to benefit from more extensive dissections, and for these patients, the proven benefits of cALND must be weighed against the significant complications associated with the procedure, including lymphedema, arm pain, nerve injury, shoulder dysfunction, and paresthesias, Dr. Savolt noted.

The OTOASOR (Optimal Treatment of the Axilla – Surgery or Radiotherapy) trial was a single-center study designed to see whether axillary radiotherapy could be noninferior to cALND for preventing recurrence and breast cancer deaths.

From mid-2002 through mid-2009,the investigators enrolled women with primary invasive breast cancer (tumors 3 cm or smaller and no clinically detected lymph node metastases), and randomized them prior to surgery to receive either cALND or axillary radiotherapy at a dose of 50 Gy. Patients also received adjuvant therapy as per institutional guidelines.

A total of 474 patients were evaluable for follow-up: 244 assigned to cALND and 230 assigned to radiotherapy. In all, 94 patients assigned to cALND (38.5%) were found to have additional lymph node metastases.

At a mean follow-up of 97 months, 2% of women in the cALND group had experienced an axillary recurrence (the primary endpoint), compared with 1.7% in the axillary radiation arm.

Overall survival was also similar between the groups, at 77.9% vs. 84.8%, respectively, as was disease-free survival, at 72.1% and 77.4%; neither comparison yielded statistically significant results.

There were also no between-group differences in the percentage of patients alive with recurrence, breast cancer deaths (13.9% of patients in the cALND arm vs. 8.7 in the radiation arm), or deaths from other causes (8.2% vs. 6.5%, respectively).

In contrast, however, 15.3% of patients assigned to cALND reported lymphedema, paresthesia, swelling, arm pain, or shoulder mobility problems, compared with 4.7% treated with radiotherapy. There were no significant differences in quality of life as assessed by standard instruments, however.

The study was supported by the Hungarian National Institute of Oncology. Dr. Savolt and colleagues reported no competing interests.

op@frontlinemedcom.com

AMSTERDAM – Axillary radiotherapy appears to be a safe and effective alternative to completion axillary lymph node dissection (cALND) for selected patients who have early invasive breast cancer with sentinel lymph node metastasis, a randomized phase III trial showed.

After a mean of just over 8 years of follow-up, there were no significant differences in breast cancer recurrence, overall survival (OS), disease-free survival (DFS), or breast cancer deaths between patients treated with cALND or axillary radiotherapy, reported Akos Savolt, MD, PhD, of the National Institute of Oncology in Budapest.

“This trial has changed our everyday practice about the optimal care of the axilla,” he said at an annual congress sponsored by the European Cancer Organisation.

An estimated 25%-50% of patients with positive sentinel lymph nodes will have disease that extends to other lymph nodes, and for these patients, cALND is the standard of care.

But patients for whom metastasis is limited to the sentinel lymph node are unlikely to benefit from more extensive dissections, and for these patients, the proven benefits of cALND must be weighed against the significant complications associated with the procedure, including lymphedema, arm pain, nerve injury, shoulder dysfunction, and paresthesias, Dr. Savolt noted.

The OTOASOR (Optimal Treatment of the Axilla – Surgery or Radiotherapy) trial was a single-center study designed to see whether axillary radiotherapy could be noninferior to cALND for preventing recurrence and breast cancer deaths.

From mid-2002 through mid-2009,the investigators enrolled women with primary invasive breast cancer (tumors 3 cm or smaller and no clinically detected lymph node metastases), and randomized them prior to surgery to receive either cALND or axillary radiotherapy at a dose of 50 Gy. Patients also received adjuvant therapy as per institutional guidelines.

A total of 474 patients were evaluable for follow-up: 244 assigned to cALND and 230 assigned to radiotherapy. In all, 94 patients assigned to cALND (38.5%) were found to have additional lymph node metastases.

At a mean follow-up of 97 months, 2% of women in the cALND group had experienced an axillary recurrence (the primary endpoint), compared with 1.7% in the axillary radiation arm.

Overall survival was also similar between the groups, at 77.9% vs. 84.8%, respectively, as was disease-free survival, at 72.1% and 77.4%; neither comparison yielded statistically significant results.

There were also no between-group differences in the percentage of patients alive with recurrence, breast cancer deaths (13.9% of patients in the cALND arm vs. 8.7 in the radiation arm), or deaths from other causes (8.2% vs. 6.5%, respectively).

In contrast, however, 15.3% of patients assigned to cALND reported lymphedema, paresthesia, swelling, arm pain, or shoulder mobility problems, compared with 4.7% treated with radiotherapy. There were no significant differences in quality of life as assessed by standard instruments, however.

The study was supported by the Hungarian National Institute of Oncology. Dr. Savolt and colleagues reported no competing interests.

op@frontlinemedcom.com

AMSTERDAM – Axillary radiotherapy appears to be a safe and effective alternative to completion axillary lymph node dissection (cALND) for selected patients who have early invasive breast cancer with sentinel lymph node metastasis, a randomized phase III trial showed.

After a mean of just over 8 years of follow-up, there were no significant differences in breast cancer recurrence, overall survival (OS), disease-free survival (DFS), or breast cancer deaths between patients treated with cALND or axillary radiotherapy, reported Akos Savolt, MD, PhD, of the National Institute of Oncology in Budapest.

“This trial has changed our everyday practice about the optimal care of the axilla,” he said at an annual congress sponsored by the European Cancer Organisation.

An estimated 25%-50% of patients with positive sentinel lymph nodes will have disease that extends to other lymph nodes, and for these patients, cALND is the standard of care.

But patients for whom metastasis is limited to the sentinel lymph node are unlikely to benefit from more extensive dissections, and for these patients, the proven benefits of cALND must be weighed against the significant complications associated with the procedure, including lymphedema, arm pain, nerve injury, shoulder dysfunction, and paresthesias, Dr. Savolt noted.

The OTOASOR (Optimal Treatment of the Axilla – Surgery or Radiotherapy) trial was a single-center study designed to see whether axillary radiotherapy could be noninferior to cALND for preventing recurrence and breast cancer deaths.

From mid-2002 through mid-2009,the investigators enrolled women with primary invasive breast cancer (tumors 3 cm or smaller and no clinically detected lymph node metastases), and randomized them prior to surgery to receive either cALND or axillary radiotherapy at a dose of 50 Gy. Patients also received adjuvant therapy as per institutional guidelines.

A total of 474 patients were evaluable for follow-up: 244 assigned to cALND and 230 assigned to radiotherapy. In all, 94 patients assigned to cALND (38.5%) were found to have additional lymph node metastases.

At a mean follow-up of 97 months, 2% of women in the cALND group had experienced an axillary recurrence (the primary endpoint), compared with 1.7% in the axillary radiation arm.

Overall survival was also similar between the groups, at 77.9% vs. 84.8%, respectively, as was disease-free survival, at 72.1% and 77.4%; neither comparison yielded statistically significant results.

There were also no between-group differences in the percentage of patients alive with recurrence, breast cancer deaths (13.9% of patients in the cALND arm vs. 8.7 in the radiation arm), or deaths from other causes (8.2% vs. 6.5%, respectively).

In contrast, however, 15.3% of patients assigned to cALND reported lymphedema, paresthesia, swelling, arm pain, or shoulder mobility problems, compared with 4.7% treated with radiotherapy. There were no significant differences in quality of life as assessed by standard instruments, however.

The study was supported by the Hungarian National Institute of Oncology. Dr. Savolt and colleagues reported no competing interests.

op@frontlinemedcom.com

WAILEA, HAWAII – Two hyaluronic acid products now available in the United States are “much more stretchable and flexible” than other fillers, according to Nowell Solish, MD, of the University of Toronto.

The dermal fillers, Restylane Defyne and Restylane Refyne, have been available in Canada, and Dr. Solish was involved in a Canadian study of the fillers in patients in motion. With the new fillers, “animation looks more natural after than before the fillers,” he said at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation. In addition to providing a more natural look, the new fillers may also help prevent the development of lines in certain areas, such as around the mouth, he noted.

In a video interview at the meeting, Dr. Solish explained that when he treats a patient, he looks for where there is “too much activity,” such as frequent pursing of the lips, and puts filler in to balance the activity.

He disclosed relationships with Allergan, Galderma (the manufacturer of Restylane products), and Revance.

SDEF and this news organization are owned by the same parent company.

WAILEA, HAWAII – Two hyaluronic acid products now available in the United States are “much more stretchable and flexible” than other fillers, according to Nowell Solish, MD, of the University of Toronto.

The dermal fillers, Restylane Defyne and Restylane Refyne, have been available in Canada, and Dr. Solish was involved in a Canadian study of the fillers in patients in motion. With the new fillers, “animation looks more natural after than before the fillers,” he said at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation. In addition to providing a more natural look, the new fillers may also help prevent the development of lines in certain areas, such as around the mouth, he noted.

In a video interview at the meeting, Dr. Solish explained that when he treats a patient, he looks for where there is “too much activity,” such as frequent pursing of the lips, and puts filler in to balance the activity.

He disclosed relationships with Allergan, Galderma (the manufacturer of Restylane products), and Revance.

SDEF and this news organization are owned by the same parent company.

WAILEA, HAWAII – Two hyaluronic acid products now available in the United States are “much more stretchable and flexible” than other fillers, according to Nowell Solish, MD, of the University of Toronto.

The dermal fillers, Restylane Defyne and Restylane Refyne, have been available in Canada, and Dr. Solish was involved in a Canadian study of the fillers in patients in motion. With the new fillers, “animation looks more natural after than before the fillers,” he said at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation. In addition to providing a more natural look, the new fillers may also help prevent the development of lines in certain areas, such as around the mouth, he noted.

In a video interview at the meeting, Dr. Solish explained that when he treats a patient, he looks for where there is “too much activity,” such as frequent pursing of the lips, and puts filler in to balance the activity.

He disclosed relationships with Allergan, Galderma (the manufacturer of Restylane products), and Revance.

SDEF and this news organization are owned by the same parent company.

Cardiopulmonary exercise testing (CPET) is a versatile tool that can be useful in patient management and clinical decision-making. Many physicians are unfamiliar with it, in part because historically it was cumbersome, done mostly in research or exercise physiology centers, and used mostly in assessing athletic fitness rather than pathologic conditions. In addition, medical schools provide little instruction about it, and hands-on use has typically been relegated to pulmonologists.

Improvements in hardware and software and ease of use have brought this test into the clinical arena to the point that clinicians should consider it earlier in the evaluation of appropriate patients. It now has a class I recommendation (ie, the test is indicated) from the American College of Cardiology and American Heart Association for evaluating exertional dyspnea of uncertain cause and for evaluating cardiac patients being considered for transplant.¹ It also is a powerful prognosticator of outcomes in heart failure patients.

CARDIOPULMONARY EXERCISE TESTING MADE SIMPLE

CPET is the analysis of gas exchange during exercise. Modern systems measure, breath-by-breath, the volume of oxygen taken up (Vo₂), and the volumes of carbon dioxide (Vco₂) and air expired (Ve).

Testing can be done with nearly any kind of exercise (treadmill, cycle, arm ergometry), thus accommodating patient or provider preference. Most exercise protocols involve a gradual increase in work rather than increasing stages of work for smooth data collection, and graphical display for optimal test interpretation.

After undergoing baseline screening spirometry, the patient rides a stationary bicycle or walks on a treadmill while breathing through a nonrebreathing mask and wearing electrocardiographic leads, a blood pressure cuff, and a pulse oximeter. The test starts out easy and gets progressively harder until the patient fatigues, reaches his or her predicted peak Vo₂, or, as in any stress test, experiences any other clinical indication for stopping, such as arrhythmias, hypotension, or symptoms (rare). We advise patients to wear comfortable workout clothes, and we ask them to try as hard as they can. The test takes about 10 to 15 minutes. Patients are instructed to take all of their usual medications, including beta-blockers, unless advised otherwise at the discretion of the supervising physician.

What the numbers mean

Table 1 lists common CPET variables; Table 2 lists common patterns of results and what they suggest. Other reviews further discuss disease-specific CPET patterns.^2–5

Peak Vo₂. As the level of work increases, the body needs more oxygen, and oxygen consumption (Vo₂^­) increases in a linear fashion up to a peak value (Figure 1). Peak Vo₂ is the central variable in CPET. Whereas elite athletes have high peak Vo₂ values, patients with exercise impairment from any cause have lower values, and average adults typically have results in the middle. Peak Vo₂ can be expressed in absolute terms as liters of oxygen per minute, in indexed terms as milliliters of oxygen per kilogram of body weight per minute, and as a percentage of the predicted value.

Ventilatory threshold. Before people reach their peak Vo₂, they reach a point where the work demand on the muscles exceeds the oxygen that is being delivered to them, and their metabolism becomes more anaerobic. This point is called the anaerobic threshold, or more precisely the ventilatory threshold. In states of deconditioning or disease, this threshold is often lower than predicted. It can be detected either directly by measuring blood lactate levels or, more often, indirectly from the Vo₂, Vco₂, and Ve data (Figure 2).

Ve/Vco₂ slope. As exercise impairment advances, ventilatory efficiency worsens. Put simply, the demands of exercise result in greater ventilatory effort at any given level of work. This is a consequence of ventilation-perfusion mismatching from a milieu of metabolic, ventilatory, and cardiac dysregulation that accompanies advanced cardiopulmonary or metabolic disease.^6,7 The most validated CPET variable reflecting this is the minute ventilation-carbon dioxide relationship (Ve/Vco₂ slope) (Figure 3).

Coupled with other common CPET variables and measures such as screening spirometry, electrocardiography, heart and respiratory rate responses, pulse oximetry, and blood pressure, the Ve/Vco₂ allows for a detailed and integrated assessment of exercise performance.

USING CPET TO EVALUATE EXERTIONAL DYSPNEA

Shortness of breath, particularly with exertion, is a common reason patients are referred to internists, pulmonologists, and cardiologists. It is a nonspecific symptom for which a precise cause can be elusive. Possible causes range from physical deconditioning due to obesity to new or progressive cardiopulmonary or muscular disease.

If conventional initial studies such as standard exercise testing, echocardiography, or spirometry do not definitively identify the problem, CPET can help guide additional investigation or management. Any abnormal patterns seen, together with the patient’s clinical context and other test results, can give direction to additional evaluation.

Table 2 outlines various CPET patterns that can suggest clinically significant cardiac, pulmonary, or muscle disorders.^8–13 Alternatively, normal responses reassure the patient and clinician, since they suggest the patient does not have clinically significant disease.

Case 1: Obesity and dyspnea

You evaluate a 53-year-old mildly obese man for dyspnea. Cardiology evaluation 1 year earlier included normal transthoracic and stress echocardiograms. He is referred for CPET.

His peak Vo₂ is low in indexed terms (22.3 mL/kg/min; 74% of predicted) but 90% of predicted in absolute terms (2.8 L/min), reflecting the contribution of his obesity. His ventilatory threshold is near the lower end of normal (50% of peak Vo₂), and all other findings are normal. You conclude his dyspnea is due to deconditioning and obesity.

Case 2: Diastolic dysfunction

You follow a normal-weight 65-year-old woman who has long-standing exertional dyspnea. Evaluation 1 year ago included an echocardiogram showing a normal left ventricular ejection fraction and grade II (moderate) diastolic dysfunction, a normal exercise stress test (details were not provided), normal pulmonary function testing, and high-resolution computed tomography of the chest. She too is referred for CPET.

The findings include mild sinus tachycardia at rest and low peak Vo₂ (23.7 mL/kg/min; 69% of predicted). The Ve/Vco₂ slope is substantially elevated at 43. Other measures of cardiopulmonary impairment and ventilatory inefficiency such as the end-tidal Pco₂ response, oxygen uptake efficiency slope, and oxygen-pulse relationship (O₂-pulse, a surrogate for stroke volume) are also abnormal. In clinical context this suggests diastolic dysfunction or unappreciated pulmonary hypertension. You refer her for right heart catheterization, which confirms findings consistent with diastolic dysfunction.

Case 3: Systemic sclerosis

A 64-year-old woman with systemic sclerosis, hypertension, diabetes, and sleep apnea is referred for CPET evaluation of dyspnea. Echocardiography 6 months ago showed a normal left ventricular ejection fraction and moderate diastolic dysfunction.

She undergoes screening spirometry. Results are abnormal and suggest restrictive disease, borderline-low breathing reserve, and low peak Vo₂ (20 mL/kg/min; 71% of predicted). She also has chronotropic incompetence (peak heart rate 105 beats per minute; 67% of predicted). These findings are thought to be manifestations of her systemic sclerosis. You refer her for both pulmonary and electrophysiology consultation.

Case 4: Mitral valve prolapse

A generally healthy 73-year-old woman undergoes echocardiography because of a murmur. Findings reveal mitral valve prolapse and mitral regurgitation, which is difficult to quantify. She is referred for CPET as a noninvasive means of assessing the hemodynamic significance of her mitral regurgitation.

Her overall peak Vo₂ is low (15 mL/kg/min). The Ve/Vco₂ slope is elevated at 32 (normal < 30), and end-tidal Pco₂ response is also abnormal. The recovery heart rate is also abnormally elevated. Collectively, these findings indicate that her mitral valve regurgitation is hemodynamically significant, and you refer her for mitral valve surgery.

CPET’S ROLE IN HEART FAILURE

Over 2 decades ago, the direct measure of peak Vo₂ during exercise was found to be an important prognosticator for patients with advanced heart failure and thus became a conventional measure for stratifying patients most in need of a heart transplant.¹⁴ To this day, a peak Vo₂ of 14 mL/kg/min remains a prognostic threshold—values this low or less carry a poor prognosis.

Additional CPET variables are prognostically useful, both independently and with each other. Many of them reflect the ventilatory and metabolic inefficiencies that result from the extensive central and peripheral pathophysiology seen in heart failure.^7,15–17

An elevated Ve/Vco₂ slope is a strong predictor of adverse outcomes for patients with heart failure with either reduced or preserved ejection fraction.^18,19 Other recognized prognostic indicators include^20–23:

Low end-tidal Pco₂

Exercise oscillatory breathing

Low oxygen uptake efficiency slope. All of these are readily provided in the reports of modern CPET systems. Explanations are in Table 1.

Collectively, these variables are strong predictors of outcomes in heart failure patients in terms of survival, adverse cardiac events, or progression to advanced therapy such as a left ventricular assist device or transplant. A multicenter consortium analyzed CPET results from more than 2,600 systolic heart failure patients and devised a scoring system for predicting outcomes (Table 3). This scoring system is a recommended component of the standard evaluation in patients with advanced heart failure.²⁴

EXERCISE TEST REPORTING

Currently there is no universal reporting format for CPET. Using a systematic approach such as the one proposed by Guazzi et al⁵ can help assure that abnormal values and patterns in all areas will be identified and incorporated in test interpretation. Table 4 lists suggested components of a CPET report and representative examples.

OTHER USES OF EXERCISE TESTING

CPET has also been found useful in several other clinical conditions that are beyond the scope of this review. These include pulmonary hypertension,²⁵ differentiation of pathologic vs physiologic hypertrophy of the left ventricle,²⁶ preclinical diastolic dysfunction,^27,28 congenital heart disease in adults,²⁹ prediction of postoperative complications in bariatric surgery,³⁰ preoperative evaluation for lung resection and pectus excavatum,^31,32 hemodynamic impact of mitral regurgitation,³³ and mitochondrial myopathies.³⁴

COST-EFFECTIVENESS UNKNOWN

The Current Procedural Terminology code for billing for CPET is 94621 (complex pulmonary stress test). The technical fee is $1,605, and the professional fee is $250. The allowable charges vary according to insurer, but under Medicare A and B, the charges are $258.93 and $70.65, respectively, of which patients typically must copay 20%. Total relative value units are 4.60, of which 1.95 are work relative value units.

The cost-effectiveness of CPET has not been studied. As illustrated in the case examples, patients often undergo numerous tests before CPET. While one might infer that CPET could streamline testing and management if done sooner in disease evaluation, this hypothesis has not been adequately studied, and further research is needed to determine if and how doing so will affect overall costs.

IMPLICATIONS FOR PRACTICE

Newer hardware and software have made CPET more available to practicing clinicians.

CPET has proven value in evaluating patients with exertional dyspnea. If first-line evaluation has not revealed an obvious cause of a patient’s dyspnea, CPET should be considered. This may avoid additional testing or streamline subsequent evaluation and management. CPET also has an established role in risk stratification of those with heart failure.

The clinical application of CPET continues to evolve. Future research will continue to refine its diagnostic and prognostic abilities in a variety of diseases. Most major hospitals and medical centers have CPET capabilities, and interested practitioners should seek out those experienced in test interpretation to increase personal familiarity and to foster appropriate patient referrals.

Cardiopulmonary exercise testing (CPET) is a versatile tool that can be useful in patient management and clinical decision-making. Many physicians are unfamiliar with it, in part because historically it was cumbersome, done mostly in research or exercise physiology centers, and used mostly in assessing athletic fitness rather than pathologic conditions. In addition, medical schools provide little instruction about it, and hands-on use has typically been relegated to pulmonologists.

Improvements in hardware and software and ease of use have brought this test into the clinical arena to the point that clinicians should consider it earlier in the evaluation of appropriate patients. It now has a class I recommendation (ie, the test is indicated) from the American College of Cardiology and American Heart Association for evaluating exertional dyspnea of uncertain cause and for evaluating cardiac patients being considered for transplant.¹ It also is a powerful prognosticator of outcomes in heart failure patients.

CARDIOPULMONARY EXERCISE TESTING MADE SIMPLE

CPET is the analysis of gas exchange during exercise. Modern systems measure, breath-by-breath, the volume of oxygen taken up (Vo₂), and the volumes of carbon dioxide (Vco₂) and air expired (Ve).

Testing can be done with nearly any kind of exercise (treadmill, cycle, arm ergometry), thus accommodating patient or provider preference. Most exercise protocols involve a gradual increase in work rather than increasing stages of work for smooth data collection, and graphical display for optimal test interpretation.

After undergoing baseline screening spirometry, the patient rides a stationary bicycle or walks on a treadmill while breathing through a nonrebreathing mask and wearing electrocardiographic leads, a blood pressure cuff, and a pulse oximeter. The test starts out easy and gets progressively harder until the patient fatigues, reaches his or her predicted peak Vo₂, or, as in any stress test, experiences any other clinical indication for stopping, such as arrhythmias, hypotension, or symptoms (rare). We advise patients to wear comfortable workout clothes, and we ask them to try as hard as they can. The test takes about 10 to 15 minutes. Patients are instructed to take all of their usual medications, including beta-blockers, unless advised otherwise at the discretion of the supervising physician.

What the numbers mean

Table 1 lists common CPET variables; Table 2 lists common patterns of results and what they suggest. Other reviews further discuss disease-specific CPET patterns.^2–5

Peak Vo₂. As the level of work increases, the body needs more oxygen, and oxygen consumption (Vo₂^­) increases in a linear fashion up to a peak value (Figure 1). Peak Vo₂ is the central variable in CPET. Whereas elite athletes have high peak Vo₂ values, patients with exercise impairment from any cause have lower values, and average adults typically have results in the middle. Peak Vo₂ can be expressed in absolute terms as liters of oxygen per minute, in indexed terms as milliliters of oxygen per kilogram of body weight per minute, and as a percentage of the predicted value.

Ventilatory threshold. Before people reach their peak Vo₂, they reach a point where the work demand on the muscles exceeds the oxygen that is being delivered to them, and their metabolism becomes more anaerobic. This point is called the anaerobic threshold, or more precisely the ventilatory threshold. In states of deconditioning or disease, this threshold is often lower than predicted. It can be detected either directly by measuring blood lactate levels or, more often, indirectly from the Vo₂, Vco₂, and Ve data (Figure 2).

Ve/Vco₂ slope. As exercise impairment advances, ventilatory efficiency worsens. Put simply, the demands of exercise result in greater ventilatory effort at any given level of work. This is a consequence of ventilation-perfusion mismatching from a milieu of metabolic, ventilatory, and cardiac dysregulation that accompanies advanced cardiopulmonary or metabolic disease.^6,7 The most validated CPET variable reflecting this is the minute ventilation-carbon dioxide relationship (Ve/Vco₂ slope) (Figure 3).

Coupled with other common CPET variables and measures such as screening spirometry, electrocardiography, heart and respiratory rate responses, pulse oximetry, and blood pressure, the Ve/Vco₂ allows for a detailed and integrated assessment of exercise performance.

USING CPET TO EVALUATE EXERTIONAL DYSPNEA

Shortness of breath, particularly with exertion, is a common reason patients are referred to internists, pulmonologists, and cardiologists. It is a nonspecific symptom for which a precise cause can be elusive. Possible causes range from physical deconditioning due to obesity to new or progressive cardiopulmonary or muscular disease.

If conventional initial studies such as standard exercise testing, echocardiography, or spirometry do not definitively identify the problem, CPET can help guide additional investigation or management. Any abnormal patterns seen, together with the patient’s clinical context and other test results, can give direction to additional evaluation.

Table 2 outlines various CPET patterns that can suggest clinically significant cardiac, pulmonary, or muscle disorders.^8–13 Alternatively, normal responses reassure the patient and clinician, since they suggest the patient does not have clinically significant disease.

Case 1: Obesity and dyspnea

You evaluate a 53-year-old mildly obese man for dyspnea. Cardiology evaluation 1 year earlier included normal transthoracic and stress echocardiograms. He is referred for CPET.

His peak Vo₂ is low in indexed terms (22.3 mL/kg/min; 74% of predicted) but 90% of predicted in absolute terms (2.8 L/min), reflecting the contribution of his obesity. His ventilatory threshold is near the lower end of normal (50% of peak Vo₂), and all other findings are normal. You conclude his dyspnea is due to deconditioning and obesity.

Case 2: Diastolic dysfunction

You follow a normal-weight 65-year-old woman who has long-standing exertional dyspnea. Evaluation 1 year ago included an echocardiogram showing a normal left ventricular ejection fraction and grade II (moderate) diastolic dysfunction, a normal exercise stress test (details were not provided), normal pulmonary function testing, and high-resolution computed tomography of the chest. She too is referred for CPET.

The findings include mild sinus tachycardia at rest and low peak Vo₂ (23.7 mL/kg/min; 69% of predicted). The Ve/Vco₂ slope is substantially elevated at 43. Other measures of cardiopulmonary impairment and ventilatory inefficiency such as the end-tidal Pco₂ response, oxygen uptake efficiency slope, and oxygen-pulse relationship (O₂-pulse, a surrogate for stroke volume) are also abnormal. In clinical context this suggests diastolic dysfunction or unappreciated pulmonary hypertension. You refer her for right heart catheterization, which confirms findings consistent with diastolic dysfunction.

Case 3: Systemic sclerosis

A 64-year-old woman with systemic sclerosis, hypertension, diabetes, and sleep apnea is referred for CPET evaluation of dyspnea. Echocardiography 6 months ago showed a normal left ventricular ejection fraction and moderate diastolic dysfunction.

She undergoes screening spirometry. Results are abnormal and suggest restrictive disease, borderline-low breathing reserve, and low peak Vo₂ (20 mL/kg/min; 71% of predicted). She also has chronotropic incompetence (peak heart rate 105 beats per minute; 67% of predicted). These findings are thought to be manifestations of her systemic sclerosis. You refer her for both pulmonary and electrophysiology consultation.

Case 4: Mitral valve prolapse

A generally healthy 73-year-old woman undergoes echocardiography because of a murmur. Findings reveal mitral valve prolapse and mitral regurgitation, which is difficult to quantify. She is referred for CPET as a noninvasive means of assessing the hemodynamic significance of her mitral regurgitation.

Her overall peak Vo₂ is low (15 mL/kg/min). The Ve/Vco₂ slope is elevated at 32 (normal < 30), and end-tidal Pco₂ response is also abnormal. The recovery heart rate is also abnormally elevated. Collectively, these findings indicate that her mitral valve regurgitation is hemodynamically significant, and you refer her for mitral valve surgery.

CPET’S ROLE IN HEART FAILURE

Over 2 decades ago, the direct measure of peak Vo₂ during exercise was found to be an important prognosticator for patients with advanced heart failure and thus became a conventional measure for stratifying patients most in need of a heart transplant.¹⁴ To this day, a peak Vo₂ of 14 mL/kg/min remains a prognostic threshold—values this low or less carry a poor prognosis.

Additional CPET variables are prognostically useful, both independently and with each other. Many of them reflect the ventilatory and metabolic inefficiencies that result from the extensive central and peripheral pathophysiology seen in heart failure.^7,15–17

An elevated Ve/Vco₂ slope is a strong predictor of adverse outcomes for patients with heart failure with either reduced or preserved ejection fraction.^18,19 Other recognized prognostic indicators include^20–23:

Low end-tidal Pco₂

Exercise oscillatory breathing

Low oxygen uptake efficiency slope. All of these are readily provided in the reports of modern CPET systems. Explanations are in Table 1.

Collectively, these variables are strong predictors of outcomes in heart failure patients in terms of survival, adverse cardiac events, or progression to advanced therapy such as a left ventricular assist device or transplant. A multicenter consortium analyzed CPET results from more than 2,600 systolic heart failure patients and devised a scoring system for predicting outcomes (Table 3). This scoring system is a recommended component of the standard evaluation in patients with advanced heart failure.²⁴

EXERCISE TEST REPORTING

Currently there is no universal reporting format for CPET. Using a systematic approach such as the one proposed by Guazzi et al⁵ can help assure that abnormal values and patterns in all areas will be identified and incorporated in test interpretation. Table 4 lists suggested components of a CPET report and representative examples.

OTHER USES OF EXERCISE TESTING

CPET has also been found useful in several other clinical conditions that are beyond the scope of this review. These include pulmonary hypertension,²⁵ differentiation of pathologic vs physiologic hypertrophy of the left ventricle,²⁶ preclinical diastolic dysfunction,^27,28 congenital heart disease in adults,²⁹ prediction of postoperative complications in bariatric surgery,³⁰ preoperative evaluation for lung resection and pectus excavatum,^31,32 hemodynamic impact of mitral regurgitation,³³ and mitochondrial myopathies.³⁴

COST-EFFECTIVENESS UNKNOWN

The Current Procedural Terminology code for billing for CPET is 94621 (complex pulmonary stress test). The technical fee is $1,605, and the professional fee is $250. The allowable charges vary according to insurer, but under Medicare A and B, the charges are $258.93 and $70.65, respectively, of which patients typically must copay 20%. Total relative value units are 4.60, of which 1.95 are work relative value units.

The cost-effectiveness of CPET has not been studied. As illustrated in the case examples, patients often undergo numerous tests before CPET. While one might infer that CPET could streamline testing and management if done sooner in disease evaluation, this hypothesis has not been adequately studied, and further research is needed to determine if and how doing so will affect overall costs.

IMPLICATIONS FOR PRACTICE

Newer hardware and software have made CPET more available to practicing clinicians.

CPET has proven value in evaluating patients with exertional dyspnea. If first-line evaluation has not revealed an obvious cause of a patient’s dyspnea, CPET should be considered. This may avoid additional testing or streamline subsequent evaluation and management. CPET also has an established role in risk stratification of those with heart failure.

The clinical application of CPET continues to evolve. Future research will continue to refine its diagnostic and prognostic abilities in a variety of diseases. Most major hospitals and medical centers have CPET capabilities, and interested practitioners should seek out those experienced in test interpretation to increase personal familiarity and to foster appropriate patient referrals.

Cardiopulmonary exercise testing (CPET) is a versatile tool that can be useful in patient management and clinical decision-making. Many physicians are unfamiliar with it, in part because historically it was cumbersome, done mostly in research or exercise physiology centers, and used mostly in assessing athletic fitness rather than pathologic conditions. In addition, medical schools provide little instruction about it, and hands-on use has typically been relegated to pulmonologists.

Improvements in hardware and software and ease of use have brought this test into the clinical arena to the point that clinicians should consider it earlier in the evaluation of appropriate patients. It now has a class I recommendation (ie, the test is indicated) from the American College of Cardiology and American Heart Association for evaluating exertional dyspnea of uncertain cause and for evaluating cardiac patients being considered for transplant.¹ It also is a powerful prognosticator of outcomes in heart failure patients.

CARDIOPULMONARY EXERCISE TESTING MADE SIMPLE

CPET is the analysis of gas exchange during exercise. Modern systems measure, breath-by-breath, the volume of oxygen taken up (Vo₂), and the volumes of carbon dioxide (Vco₂) and air expired (Ve).

Testing can be done with nearly any kind of exercise (treadmill, cycle, arm ergometry), thus accommodating patient or provider preference. Most exercise protocols involve a gradual increase in work rather than increasing stages of work for smooth data collection, and graphical display for optimal test interpretation.

After undergoing baseline screening spirometry, the patient rides a stationary bicycle or walks on a treadmill while breathing through a nonrebreathing mask and wearing electrocardiographic leads, a blood pressure cuff, and a pulse oximeter. The test starts out easy and gets progressively harder until the patient fatigues, reaches his or her predicted peak Vo₂, or, as in any stress test, experiences any other clinical indication for stopping, such as arrhythmias, hypotension, or symptoms (rare). We advise patients to wear comfortable workout clothes, and we ask them to try as hard as they can. The test takes about 10 to 15 minutes. Patients are instructed to take all of their usual medications, including beta-blockers, unless advised otherwise at the discretion of the supervising physician.

What the numbers mean

Table 1 lists common CPET variables; Table 2 lists common patterns of results and what they suggest. Other reviews further discuss disease-specific CPET patterns.^2–5

Peak Vo₂. As the level of work increases, the body needs more oxygen, and oxygen consumption (Vo₂^­) increases in a linear fashion up to a peak value (Figure 1). Peak Vo₂ is the central variable in CPET. Whereas elite athletes have high peak Vo₂ values, patients with exercise impairment from any cause have lower values, and average adults typically have results in the middle. Peak Vo₂ can be expressed in absolute terms as liters of oxygen per minute, in indexed terms as milliliters of oxygen per kilogram of body weight per minute, and as a percentage of the predicted value.

Ventilatory threshold. Before people reach their peak Vo₂, they reach a point where the work demand on the muscles exceeds the oxygen that is being delivered to them, and their metabolism becomes more anaerobic. This point is called the anaerobic threshold, or more precisely the ventilatory threshold. In states of deconditioning or disease, this threshold is often lower than predicted. It can be detected either directly by measuring blood lactate levels or, more often, indirectly from the Vo₂, Vco₂, and Ve data (Figure 2).

Ve/Vco₂ slope. As exercise impairment advances, ventilatory efficiency worsens. Put simply, the demands of exercise result in greater ventilatory effort at any given level of work. This is a consequence of ventilation-perfusion mismatching from a milieu of metabolic, ventilatory, and cardiac dysregulation that accompanies advanced cardiopulmonary or metabolic disease.^6,7 The most validated CPET variable reflecting this is the minute ventilation-carbon dioxide relationship (Ve/Vco₂ slope) (Figure 3).

Coupled with other common CPET variables and measures such as screening spirometry, electrocardiography, heart and respiratory rate responses, pulse oximetry, and blood pressure, the Ve/Vco₂ allows for a detailed and integrated assessment of exercise performance.

USING CPET TO EVALUATE EXERTIONAL DYSPNEA

Shortness of breath, particularly with exertion, is a common reason patients are referred to internists, pulmonologists, and cardiologists. It is a nonspecific symptom for which a precise cause can be elusive. Possible causes range from physical deconditioning due to obesity to new or progressive cardiopulmonary or muscular disease.

If conventional initial studies such as standard exercise testing, echocardiography, or spirometry do not definitively identify the problem, CPET can help guide additional investigation or management. Any abnormal patterns seen, together with the patient’s clinical context and other test results, can give direction to additional evaluation.

Table 2 outlines various CPET patterns that can suggest clinically significant cardiac, pulmonary, or muscle disorders.^8–13 Alternatively, normal responses reassure the patient and clinician, since they suggest the patient does not have clinically significant disease.

Case 1: Obesity and dyspnea

You evaluate a 53-year-old mildly obese man for dyspnea. Cardiology evaluation 1 year earlier included normal transthoracic and stress echocardiograms. He is referred for CPET.

His peak Vo₂ is low in indexed terms (22.3 mL/kg/min; 74% of predicted) but 90% of predicted in absolute terms (2.8 L/min), reflecting the contribution of his obesity. His ventilatory threshold is near the lower end of normal (50% of peak Vo₂), and all other findings are normal. You conclude his dyspnea is due to deconditioning and obesity.

Case 2: Diastolic dysfunction

You follow a normal-weight 65-year-old woman who has long-standing exertional dyspnea. Evaluation 1 year ago included an echocardiogram showing a normal left ventricular ejection fraction and grade II (moderate) diastolic dysfunction, a normal exercise stress test (details were not provided), normal pulmonary function testing, and high-resolution computed tomography of the chest. She too is referred for CPET.

The findings include mild sinus tachycardia at rest and low peak Vo₂ (23.7 mL/kg/min; 69% of predicted). The Ve/Vco₂ slope is substantially elevated at 43. Other measures of cardiopulmonary impairment and ventilatory inefficiency such as the end-tidal Pco₂ response, oxygen uptake efficiency slope, and oxygen-pulse relationship (O₂-pulse, a surrogate for stroke volume) are also abnormal. In clinical context this suggests diastolic dysfunction or unappreciated pulmonary hypertension. You refer her for right heart catheterization, which confirms findings consistent with diastolic dysfunction.

Case 3: Systemic sclerosis

A 64-year-old woman with systemic sclerosis, hypertension, diabetes, and sleep apnea is referred for CPET evaluation of dyspnea. Echocardiography 6 months ago showed a normal left ventricular ejection fraction and moderate diastolic dysfunction.

She undergoes screening spirometry. Results are abnormal and suggest restrictive disease, borderline-low breathing reserve, and low peak Vo₂ (20 mL/kg/min; 71% of predicted). She also has chronotropic incompetence (peak heart rate 105 beats per minute; 67% of predicted). These findings are thought to be manifestations of her systemic sclerosis. You refer her for both pulmonary and electrophysiology consultation.

Case 4: Mitral valve prolapse

A generally healthy 73-year-old woman undergoes echocardiography because of a murmur. Findings reveal mitral valve prolapse and mitral regurgitation, which is difficult to quantify. She is referred for CPET as a noninvasive means of assessing the hemodynamic significance of her mitral regurgitation.

Her overall peak Vo₂ is low (15 mL/kg/min). The Ve/Vco₂ slope is elevated at 32 (normal < 30), and end-tidal Pco₂ response is also abnormal. The recovery heart rate is also abnormally elevated. Collectively, these findings indicate that her mitral valve regurgitation is hemodynamically significant, and you refer her for mitral valve surgery.

CPET’S ROLE IN HEART FAILURE

Over 2 decades ago, the direct measure of peak Vo₂ during exercise was found to be an important prognosticator for patients with advanced heart failure and thus became a conventional measure for stratifying patients most in need of a heart transplant.¹⁴ To this day, a peak Vo₂ of 14 mL/kg/min remains a prognostic threshold—values this low or less carry a poor prognosis.

Additional CPET variables are prognostically useful, both independently and with each other. Many of them reflect the ventilatory and metabolic inefficiencies that result from the extensive central and peripheral pathophysiology seen in heart failure.^7,15–17

An elevated Ve/Vco₂ slope is a strong predictor of adverse outcomes for patients with heart failure with either reduced or preserved ejection fraction.^18,19 Other recognized prognostic indicators include^20–23:

Low end-tidal Pco₂

Exercise oscillatory breathing

Low oxygen uptake efficiency slope. All of these are readily provided in the reports of modern CPET systems. Explanations are in Table 1.

Collectively, these variables are strong predictors of outcomes in heart failure patients in terms of survival, adverse cardiac events, or progression to advanced therapy such as a left ventricular assist device or transplant. A multicenter consortium analyzed CPET results from more than 2,600 systolic heart failure patients and devised a scoring system for predicting outcomes (Table 3). This scoring system is a recommended component of the standard evaluation in patients with advanced heart failure.²⁴

EXERCISE TEST REPORTING

Currently there is no universal reporting format for CPET. Using a systematic approach such as the one proposed by Guazzi et al⁵ can help assure that abnormal values and patterns in all areas will be identified and incorporated in test interpretation. Table 4 lists suggested components of a CPET report and representative examples.

OTHER USES OF EXERCISE TESTING

CPET has also been found useful in several other clinical conditions that are beyond the scope of this review. These include pulmonary hypertension,²⁵ differentiation of pathologic vs physiologic hypertrophy of the left ventricle,²⁶ preclinical diastolic dysfunction,^27,28 congenital heart disease in adults,²⁹ prediction of postoperative complications in bariatric surgery,³⁰ preoperative evaluation for lung resection and pectus excavatum,^31,32 hemodynamic impact of mitral regurgitation,³³ and mitochondrial myopathies.³⁴

COST-EFFECTIVENESS UNKNOWN

The Current Procedural Terminology code for billing for CPET is 94621 (complex pulmonary stress test). The technical fee is $1,605, and the professional fee is $250. The allowable charges vary according to insurer, but under Medicare A and B, the charges are $258.93 and $70.65, respectively, of which patients typically must copay 20%. Total relative value units are 4.60, of which 1.95 are work relative value units.

The cost-effectiveness of CPET has not been studied. As illustrated in the case examples, patients often undergo numerous tests before CPET. While one might infer that CPET could streamline testing and management if done sooner in disease evaluation, this hypothesis has not been adequately studied, and further research is needed to determine if and how doing so will affect overall costs.

IMPLICATIONS FOR PRACTICE

Newer hardware and software have made CPET more available to practicing clinicians.

CPET has proven value in evaluating patients with exertional dyspnea. If first-line evaluation has not revealed an obvious cause of a patient’s dyspnea, CPET should be considered. This may avoid additional testing or streamline subsequent evaluation and management. CPET also has an established role in risk stratification of those with heart failure.

The clinical application of CPET continues to evolve. Future research will continue to refine its diagnostic and prognostic abilities in a variety of diseases. Most major hospitals and medical centers have CPET capabilities, and interested practitioners should seek out those experienced in test interpretation to increase personal familiarity and to foster appropriate patient referrals.