Competency in paracentesis is an important procedural skill for medical practitioners caring for patients with decompensated liver cirrhosis. Paracentesis is performed to drain ascitic fluid for both diagnosis and/or therapeutic purposes.¹ While this procedure can be performed without the use of ultrasound, it is preferable to use ultrasound to identify an area of fluid that is away from dangerous anatomy including bowel loops, the liver, and spleen. After prepping the area, lidocaine is administered locally. A catheter is then inserted until fluid begins flowing freely. The catheter is connected to a suction canister or collection kit, and the patient is monitored until the flow ceases. Samples can be sent for analysis to determine the etiology of ascites, identify concerns for infection, and more.

Paracentesis is a very common procedure. Barsuk and colleagues noted that between 2010 and 2012, 97,577 procedures were performed across 120 academic medical centers and 290 affiliated hospitals.² Patients undergo paracentesis in a variety of settings including the emergency department, inpatient hospitalizations, and clinics. Some patients may require only 1 paracentesis procedure while others may require it regularly.

Due to the rising need for paracentesis in the Central Texas Veterans Affairs Hospital (CTVAH) in Temple, a paracentesis clinic was started in February 2018. The goal of the paracentesis clinic was multifocal—to reduce hospital admissions, improve access to regularly scheduled procedures, decrease wait times, and increase patient satisfaction.³ Through the CTVAH affiliation with the Texas A&M internal medicine residency program, the paracentesis clinic started involving and training residents on this procedure. Up to 3 residents are on weekly rotation and can perform up to 6 paracentesis procedures in a week. The purpose of this article was to evaluate resident competency in paracentesis after completion of the paracentesis clinic.

Methods

The paracentesis clinic schedules up to 3 patients on Tuesdays and Thursdays between 8 am and noon. All the necessary equipment is readily available and includes the paracentesis kit, lidocaine, sterile gloves, ultrasound, and albumin if needed. Because this procedure is performed at the hospital, direct access to the emergency department is available. Residents are scheduled weekly. Up to 2 residents are scheduled for the paracentesis clinic during their dedicated clinic week. They are expected to practice obtaining consent, performing the procedure, and documenting the encounter under staff supervision. Additionally, 1 or 2 residents participate in the paracentesis clinic as part of an ultrasound elective twice per year. In this elective, they practice ultrasound skills using a simulation and translate that information in the paracentesis clinic while identifying anatomy and performing the paracentesis procedure under staff supervision.

A survey was sent via email to all categorical internal medicine residents across all 3 program years at the time of data collection. Competency for paracentesis sign-off was defined as completing and logging 5 procedures supervised by a competent physician who confirmed that all portions of the procedure were performed correctly. Residents were also asked to answer questions on a scale from 1 to 10, with 1 representing no confidence and 10 representing strong confidence to practice independently (Table).

We also evaluated the number of procedures performed by internal medicine residents 3 years before the clinic was started in 2015 up to the completion of 2022. The numbers were obtained by examining procedural log data for each year for all internal medicine residents.

Results

Thirty-three residents completed the survey: 10 first-year internal medicine residents (PGY1), 12 second-year residents (PGY2), and 11 third-year residents (PGY3). The mean participation was 4.8 paracentesis sessions per person for the duration of the study. The range of paracentesis procedures performed varied based on PGY year: PGY1s performed 1 to > 10 procedures, PGY2s performed 2 to > 10 procedures, and PGY3s performed 5 to > 10 procedures. Thirty-six percent of residents completed > 10 procedures in the paracentesis clinic; 82% of PGY3s had completed > 10 procedures by December of their third year. Twenty-six residents (79%) were credentialed to perform paracentesis procedures independently after performing > 5 procedures, and 7 residents were not yet cleared for procedural independence.

In the survey, residents rated their comfort with performing paracentesis procedures independently at a mean of 7.9. The mean comfort reported by PGY1s was 7.2, PGY2s was 7.3, and PGY3s was 9.3. Residents also rated their opinion on whether or not the paracentesis clinic adequately prepared them for paracentesis procedural independence; the mean was 8.9 across all residents.

The total number of procedures performed by residents at CTVAH also increased. Starting in 2015, 3 years before the clinic was started, 38 procedures were performed by internal medicine residents, followed by 72 procedures in 2016; 76 in 2017; 58 in 2018; 94 in 2019; 88 in 2020; 136 in 2021; and 188 in 2022.

Paracentesis is a simple but invasive procedure to relieve ascites, often relieving patients’ symptoms, preventing hospital admission, and increasing patient satisfaction.⁴ The CTVAH does not have the capacity to perform outpatient paracentesis effectively in its emergency or radiology departments. Furthermore, the use of the emergency or radiology departments for routine paracentesis may not be feasible due to the acuity of care being provided, as these procedures can be time consuming and can draw away critical resources and time from patients that need emergent care. The paracentesis clinic was then formed to provide veterans access to the procedural care they need, while also preparing residents to ably and confidently perform the procedure independently.

Based on our study, most residents were cleared to independently perform paracentesis procedures across all 3 years, with 79% of residents having completed the required 5 supervised procedures to independently practice. A study assessing unsupervised practice standards showed that paracentesis skill declines as soon as 3 months after training. However, retraining was shown to potentially interrupt this skill decline.⁵ Studies have shown that procedure-driven electives or services significantly improved paracentesis certification rates and total logged procedures, with minimal funding or scheduling changes required.⁶ Our clinic showed a significant increase in the number of procedures logged starting with the minimum of 38 procedures in 2015 and ending with 188 procedures logged at the end of 2022.

By allowing residents to routinely return to the paracentesis clinic across all 3 years, residents were more likely to feel comfortable independently performing the procedure, with residents reporting a mean comfort score of 7.9. The spaced repetition and ability to work with the clinic during elective time allows regular opportunities to undergo supervised training in a controlled environment and created scheduled retraining opportunities. Future studies should evaluate residents prior to each paracentesis clinic to ascertain if skill decline is occurring at a slower rate.

The inpatient effect of the clinic is also multifocal. Pham and colleagues showed that integrating paracentesis into timely training can reduce paracentesis delay and delays in care.⁷ By increasing the volume of procedures each resident performs and creating a sense of confidence amongst residents, the clinic increases the number of residents able and willing to perform inpatient procedures, thus reducing the number of unnecessary consultations and hospital resources. One of the reasons the paracentesis clinic was started was to allow patients to have scheduled times to remove fluid from their abdomen, thus cutting down on emergency department procedures and unnecessary admissions. Additionally, the benefits of early paracentesis procedural performance by residents and internal medicine physicians have been demonstrated in the literature. A study by Gaetano and colleagues noted that patients undergoing early paracentesis had reduced mortality of 5.5% vs 7.5% in those undergoing late paracentesis.⁸ This study also showed the in-hospital mortality rate was decreased with paracentesis (6.3%) vs without paracentesis (8.9%).⁸ By offering residents a chance to participate in the clinic, we have shown that regular opportunities to perform paracentesis may increase the number of physicians capable of independently practicing, improve procedural competency, and improve patient access to this procedure.

Limitations

Our study was not free of bias and has potential weaknesses. The survey was sent to all current residents who have participated in the paracentesis clinic, but not every resident filled out the survey (55% of all residents across 3 years completed the survey, 68.7% who had done clinic that year completed the survey). There is a possibility that those not signed off avoided doing the survey, but we are unable to confirm this. The survey also depended on resident recall of the number of paracenteses completed or looking at their procedure log. It is possible that some procedures were not documented, changing the true number. Additionally, rating comfortability with procedures is subjective, which may also create a source of potential weakness. Future projects should include a baseline survey for residents, followed by a repeat survey a year later to show changes from baseline competency.

Conclusions

A dedicated paracentesis clinic with internal medicine resident involvement may increase resident paracentesis procedural independence, the number of procedures available and performed, and procedural comfort level.

Competency in paracentesis is an important procedural skill for medical practitioners caring for patients with decompensated liver cirrhosis. Paracentesis is performed to drain ascitic fluid for both diagnosis and/or therapeutic purposes.¹ While this procedure can be performed without the use of ultrasound, it is preferable to use ultrasound to identify an area of fluid that is away from dangerous anatomy including bowel loops, the liver, and spleen. After prepping the area, lidocaine is administered locally. A catheter is then inserted until fluid begins flowing freely. The catheter is connected to a suction canister or collection kit, and the patient is monitored until the flow ceases. Samples can be sent for analysis to determine the etiology of ascites, identify concerns for infection, and more.

Paracentesis is a very common procedure. Barsuk and colleagues noted that between 2010 and 2012, 97,577 procedures were performed across 120 academic medical centers and 290 affiliated hospitals.² Patients undergo paracentesis in a variety of settings including the emergency department, inpatient hospitalizations, and clinics. Some patients may require only 1 paracentesis procedure while others may require it regularly.

Due to the rising need for paracentesis in the Central Texas Veterans Affairs Hospital (CTVAH) in Temple, a paracentesis clinic was started in February 2018. The goal of the paracentesis clinic was multifocal—to reduce hospital admissions, improve access to regularly scheduled procedures, decrease wait times, and increase patient satisfaction.³ Through the CTVAH affiliation with the Texas A&M internal medicine residency program, the paracentesis clinic started involving and training residents on this procedure. Up to 3 residents are on weekly rotation and can perform up to 6 paracentesis procedures in a week. The purpose of this article was to evaluate resident competency in paracentesis after completion of the paracentesis clinic.

Methods

The paracentesis clinic schedules up to 3 patients on Tuesdays and Thursdays between 8 am and noon. All the necessary equipment is readily available and includes the paracentesis kit, lidocaine, sterile gloves, ultrasound, and albumin if needed. Because this procedure is performed at the hospital, direct access to the emergency department is available. Residents are scheduled weekly. Up to 2 residents are scheduled for the paracentesis clinic during their dedicated clinic week. They are expected to practice obtaining consent, performing the procedure, and documenting the encounter under staff supervision. Additionally, 1 or 2 residents participate in the paracentesis clinic as part of an ultrasound elective twice per year. In this elective, they practice ultrasound skills using a simulation and translate that information in the paracentesis clinic while identifying anatomy and performing the paracentesis procedure under staff supervision.

A survey was sent via email to all categorical internal medicine residents across all 3 program years at the time of data collection. Competency for paracentesis sign-off was defined as completing and logging 5 procedures supervised by a competent physician who confirmed that all portions of the procedure were performed correctly. Residents were also asked to answer questions on a scale from 1 to 10, with 1 representing no confidence and 10 representing strong confidence to practice independently (Table).

We also evaluated the number of procedures performed by internal medicine residents 3 years before the clinic was started in 2015 up to the completion of 2022. The numbers were obtained by examining procedural log data for each year for all internal medicine residents.

Results

Thirty-three residents completed the survey: 10 first-year internal medicine residents (PGY1), 12 second-year residents (PGY2), and 11 third-year residents (PGY3). The mean participation was 4.8 paracentesis sessions per person for the duration of the study. The range of paracentesis procedures performed varied based on PGY year: PGY1s performed 1 to > 10 procedures, PGY2s performed 2 to > 10 procedures, and PGY3s performed 5 to > 10 procedures. Thirty-six percent of residents completed > 10 procedures in the paracentesis clinic; 82% of PGY3s had completed > 10 procedures by December of their third year. Twenty-six residents (79%) were credentialed to perform paracentesis procedures independently after performing > 5 procedures, and 7 residents were not yet cleared for procedural independence.

In the survey, residents rated their comfort with performing paracentesis procedures independently at a mean of 7.9. The mean comfort reported by PGY1s was 7.2, PGY2s was 7.3, and PGY3s was 9.3. Residents also rated their opinion on whether or not the paracentesis clinic adequately prepared them for paracentesis procedural independence; the mean was 8.9 across all residents.

The total number of procedures performed by residents at CTVAH also increased. Starting in 2015, 3 years before the clinic was started, 38 procedures were performed by internal medicine residents, followed by 72 procedures in 2016; 76 in 2017; 58 in 2018; 94 in 2019; 88 in 2020; 136 in 2021; and 188 in 2022.

Paracentesis is a simple but invasive procedure to relieve ascites, often relieving patients’ symptoms, preventing hospital admission, and increasing patient satisfaction.⁴ The CTVAH does not have the capacity to perform outpatient paracentesis effectively in its emergency or radiology departments. Furthermore, the use of the emergency or radiology departments for routine paracentesis may not be feasible due to the acuity of care being provided, as these procedures can be time consuming and can draw away critical resources and time from patients that need emergent care. The paracentesis clinic was then formed to provide veterans access to the procedural care they need, while also preparing residents to ably and confidently perform the procedure independently.

Based on our study, most residents were cleared to independently perform paracentesis procedures across all 3 years, with 79% of residents having completed the required 5 supervised procedures to independently practice. A study assessing unsupervised practice standards showed that paracentesis skill declines as soon as 3 months after training. However, retraining was shown to potentially interrupt this skill decline.⁵ Studies have shown that procedure-driven electives or services significantly improved paracentesis certification rates and total logged procedures, with minimal funding or scheduling changes required.⁶ Our clinic showed a significant increase in the number of procedures logged starting with the minimum of 38 procedures in 2015 and ending with 188 procedures logged at the end of 2022.

By allowing residents to routinely return to the paracentesis clinic across all 3 years, residents were more likely to feel comfortable independently performing the procedure, with residents reporting a mean comfort score of 7.9. The spaced repetition and ability to work with the clinic during elective time allows regular opportunities to undergo supervised training in a controlled environment and created scheduled retraining opportunities. Future studies should evaluate residents prior to each paracentesis clinic to ascertain if skill decline is occurring at a slower rate.

The inpatient effect of the clinic is also multifocal. Pham and colleagues showed that integrating paracentesis into timely training can reduce paracentesis delay and delays in care.⁷ By increasing the volume of procedures each resident performs and creating a sense of confidence amongst residents, the clinic increases the number of residents able and willing to perform inpatient procedures, thus reducing the number of unnecessary consultations and hospital resources. One of the reasons the paracentesis clinic was started was to allow patients to have scheduled times to remove fluid from their abdomen, thus cutting down on emergency department procedures and unnecessary admissions. Additionally, the benefits of early paracentesis procedural performance by residents and internal medicine physicians have been demonstrated in the literature. A study by Gaetano and colleagues noted that patients undergoing early paracentesis had reduced mortality of 5.5% vs 7.5% in those undergoing late paracentesis.⁸ This study also showed the in-hospital mortality rate was decreased with paracentesis (6.3%) vs without paracentesis (8.9%).⁸ By offering residents a chance to participate in the clinic, we have shown that regular opportunities to perform paracentesis may increase the number of physicians capable of independently practicing, improve procedural competency, and improve patient access to this procedure.

Limitations

Our study was not free of bias and has potential weaknesses. The survey was sent to all current residents who have participated in the paracentesis clinic, but not every resident filled out the survey (55% of all residents across 3 years completed the survey, 68.7% who had done clinic that year completed the survey). There is a possibility that those not signed off avoided doing the survey, but we are unable to confirm this. The survey also depended on resident recall of the number of paracenteses completed or looking at their procedure log. It is possible that some procedures were not documented, changing the true number. Additionally, rating comfortability with procedures is subjective, which may also create a source of potential weakness. Future projects should include a baseline survey for residents, followed by a repeat survey a year later to show changes from baseline competency.

Conclusions

A dedicated paracentesis clinic with internal medicine resident involvement may increase resident paracentesis procedural independence, the number of procedures available and performed, and procedural comfort level.

Competency in paracentesis is an important procedural skill for medical practitioners caring for patients with decompensated liver cirrhosis. Paracentesis is performed to drain ascitic fluid for both diagnosis and/or therapeutic purposes.¹ While this procedure can be performed without the use of ultrasound, it is preferable to use ultrasound to identify an area of fluid that is away from dangerous anatomy including bowel loops, the liver, and spleen. After prepping the area, lidocaine is administered locally. A catheter is then inserted until fluid begins flowing freely. The catheter is connected to a suction canister or collection kit, and the patient is monitored until the flow ceases. Samples can be sent for analysis to determine the etiology of ascites, identify concerns for infection, and more.

Paracentesis is a very common procedure. Barsuk and colleagues noted that between 2010 and 2012, 97,577 procedures were performed across 120 academic medical centers and 290 affiliated hospitals.² Patients undergo paracentesis in a variety of settings including the emergency department, inpatient hospitalizations, and clinics. Some patients may require only 1 paracentesis procedure while others may require it regularly.

Due to the rising need for paracentesis in the Central Texas Veterans Affairs Hospital (CTVAH) in Temple, a paracentesis clinic was started in February 2018. The goal of the paracentesis clinic was multifocal—to reduce hospital admissions, improve access to regularly scheduled procedures, decrease wait times, and increase patient satisfaction.³ Through the CTVAH affiliation with the Texas A&M internal medicine residency program, the paracentesis clinic started involving and training residents on this procedure. Up to 3 residents are on weekly rotation and can perform up to 6 paracentesis procedures in a week. The purpose of this article was to evaluate resident competency in paracentesis after completion of the paracentesis clinic.

Methods

The paracentesis clinic schedules up to 3 patients on Tuesdays and Thursdays between 8 am and noon. All the necessary equipment is readily available and includes the paracentesis kit, lidocaine, sterile gloves, ultrasound, and albumin if needed. Because this procedure is performed at the hospital, direct access to the emergency department is available. Residents are scheduled weekly. Up to 2 residents are scheduled for the paracentesis clinic during their dedicated clinic week. They are expected to practice obtaining consent, performing the procedure, and documenting the encounter under staff supervision. Additionally, 1 or 2 residents participate in the paracentesis clinic as part of an ultrasound elective twice per year. In this elective, they practice ultrasound skills using a simulation and translate that information in the paracentesis clinic while identifying anatomy and performing the paracentesis procedure under staff supervision.

A survey was sent via email to all categorical internal medicine residents across all 3 program years at the time of data collection. Competency for paracentesis sign-off was defined as completing and logging 5 procedures supervised by a competent physician who confirmed that all portions of the procedure were performed correctly. Residents were also asked to answer questions on a scale from 1 to 10, with 1 representing no confidence and 10 representing strong confidence to practice independently (Table).

We also evaluated the number of procedures performed by internal medicine residents 3 years before the clinic was started in 2015 up to the completion of 2022. The numbers were obtained by examining procedural log data for each year for all internal medicine residents.

Results

Thirty-three residents completed the survey: 10 first-year internal medicine residents (PGY1), 12 second-year residents (PGY2), and 11 third-year residents (PGY3). The mean participation was 4.8 paracentesis sessions per person for the duration of the study. The range of paracentesis procedures performed varied based on PGY year: PGY1s performed 1 to > 10 procedures, PGY2s performed 2 to > 10 procedures, and PGY3s performed 5 to > 10 procedures. Thirty-six percent of residents completed > 10 procedures in the paracentesis clinic; 82% of PGY3s had completed > 10 procedures by December of their third year. Twenty-six residents (79%) were credentialed to perform paracentesis procedures independently after performing > 5 procedures, and 7 residents were not yet cleared for procedural independence.

In the survey, residents rated their comfort with performing paracentesis procedures independently at a mean of 7.9. The mean comfort reported by PGY1s was 7.2, PGY2s was 7.3, and PGY3s was 9.3. Residents also rated their opinion on whether or not the paracentesis clinic adequately prepared them for paracentesis procedural independence; the mean was 8.9 across all residents.

The total number of procedures performed by residents at CTVAH also increased. Starting in 2015, 3 years before the clinic was started, 38 procedures were performed by internal medicine residents, followed by 72 procedures in 2016; 76 in 2017; 58 in 2018; 94 in 2019; 88 in 2020; 136 in 2021; and 188 in 2022.

Paracentesis is a simple but invasive procedure to relieve ascites, often relieving patients’ symptoms, preventing hospital admission, and increasing patient satisfaction.⁴ The CTVAH does not have the capacity to perform outpatient paracentesis effectively in its emergency or radiology departments. Furthermore, the use of the emergency or radiology departments for routine paracentesis may not be feasible due to the acuity of care being provided, as these procedures can be time consuming and can draw away critical resources and time from patients that need emergent care. The paracentesis clinic was then formed to provide veterans access to the procedural care they need, while also preparing residents to ably and confidently perform the procedure independently.

Based on our study, most residents were cleared to independently perform paracentesis procedures across all 3 years, with 79% of residents having completed the required 5 supervised procedures to independently practice. A study assessing unsupervised practice standards showed that paracentesis skill declines as soon as 3 months after training. However, retraining was shown to potentially interrupt this skill decline.⁵ Studies have shown that procedure-driven electives or services significantly improved paracentesis certification rates and total logged procedures, with minimal funding or scheduling changes required.⁶ Our clinic showed a significant increase in the number of procedures logged starting with the minimum of 38 procedures in 2015 and ending with 188 procedures logged at the end of 2022.

By allowing residents to routinely return to the paracentesis clinic across all 3 years, residents were more likely to feel comfortable independently performing the procedure, with residents reporting a mean comfort score of 7.9. The spaced repetition and ability to work with the clinic during elective time allows regular opportunities to undergo supervised training in a controlled environment and created scheduled retraining opportunities. Future studies should evaluate residents prior to each paracentesis clinic to ascertain if skill decline is occurring at a slower rate.

The inpatient effect of the clinic is also multifocal. Pham and colleagues showed that integrating paracentesis into timely training can reduce paracentesis delay and delays in care.⁷ By increasing the volume of procedures each resident performs and creating a sense of confidence amongst residents, the clinic increases the number of residents able and willing to perform inpatient procedures, thus reducing the number of unnecessary consultations and hospital resources. One of the reasons the paracentesis clinic was started was to allow patients to have scheduled times to remove fluid from their abdomen, thus cutting down on emergency department procedures and unnecessary admissions. Additionally, the benefits of early paracentesis procedural performance by residents and internal medicine physicians have been demonstrated in the literature. A study by Gaetano and colleagues noted that patients undergoing early paracentesis had reduced mortality of 5.5% vs 7.5% in those undergoing late paracentesis.⁸ This study also showed the in-hospital mortality rate was decreased with paracentesis (6.3%) vs without paracentesis (8.9%).⁸ By offering residents a chance to participate in the clinic, we have shown that regular opportunities to perform paracentesis may increase the number of physicians capable of independently practicing, improve procedural competency, and improve patient access to this procedure.

Limitations

Our study was not free of bias and has potential weaknesses. The survey was sent to all current residents who have participated in the paracentesis clinic, but not every resident filled out the survey (55% of all residents across 3 years completed the survey, 68.7% who had done clinic that year completed the survey). There is a possibility that those not signed off avoided doing the survey, but we are unable to confirm this. The survey also depended on resident recall of the number of paracenteses completed or looking at their procedure log. It is possible that some procedures were not documented, changing the true number. Additionally, rating comfortability with procedures is subjective, which may also create a source of potential weakness. Future projects should include a baseline survey for residents, followed by a repeat survey a year later to show changes from baseline competency.

Conclusions

A dedicated paracentesis clinic with internal medicine resident involvement may increase resident paracentesis procedural independence, the number of procedures available and performed, and procedural comfort level.

Piperacillin/tazobactam (PTZ) is a combination IV antibiotic comprised of the semisynthetic antipseudomonal β-lactam, piperacillin sodium, and the β-lactamase inhibitor, tazobactam sodium.¹ PTZ is extensively prescribed in the hospital setting for a multitude of infections including but not limited to the US Food and Drug Administration–approved indications: intra-abdominal infection, skin and skin structure infection (SSTI), urinary tract infection (UTI), and pneumonia. Given its broad spectrum of activity and relative safety profile, PTZ is a mainstay of many empiric IV antibiotic regimens. The primary elimination pathway for PTZ is renal excretion, and dosage adjustments are recommended with reduced creatinine clearance. Additionally, PTZ use has been associated with acute renal injury and delayed renal recovery.^1-3

There are various mechanisms through which medications can contribute to acute decomopensated heart failure (ADHF).⁴ These mechanisms include direct cardiotoxicity; negative inotropic, lusitropic, or chronotropic effects; exacerbating hypertension; sodium loading; and drug-drug interactions that limit the benefits of heart failure (HF) medications. One potentially overlooked constituent of PTZ is the sodium content, with the standard formulation containing 65 mg of sodium per gram of piperacillin.^1-3 Furthermore, PTZ must be diluted in 50 to 150 mL of diluent, commonly 0.9% sodium chloride, which can contribute an additional 177 to 531 mg of sodium per dose. PTZ prescribing information advises caution for use in patients with decreased renal, hepatic, and/or cardiac function and notes that geriatric patients, particularly with HF, may be at risk of impaired natriuresis in the setting of large sodium doses.

It is estimated that roughly 6.2 million adults in the United States have HF and prevalence continues to rise.^5,6 Mortality rates after hospitalization due to HF are 20% to 25% at 1 year. Health care expenditures for the management of HF surpass $30 billion per year in the US, with most of this cost attributed to hospitalizations. Consequently, it is important to continue to identify and practice preventative strategies when managing patients with HF.

Methods

This single-center, retrospective, cohort study was conducted at James H. Quillen Veterans Affairs Medical Center (JHQVAMC) in Mountain Home, Tennessee, a 174-bed tertiary medical center. The purpose of this study was to compare the incidence of ADHF in patients who received PTZ vs cefepime (CFP). This project was reviewed by the JHQVAMC Institutional Review Board and deemed exempt as a clinical process improvement operations activity.

The antimicrobial stewardship team at JHQVAMC reviewed the use of PTZ in veterans between January 1, 2018, to December 31, 2019, and compared baseline demographics, history of HF, and outcomes in patients receiving analogous broad-spectrum empiric antibiotic therapy with CFP. Patients were included if they received at least 24 hours of PTZ or CFP. Patients were excluded if they were diagnosed with ADHF before initiation of antibiotic therapy. Patients with ADHF were identified by clinical diagnosis of ADHF documented by the treating clinician and reaffirmed by the study clinician during retrospective chart review. Clinical information used to determine ADHF included clinical presentation, imaging (ie, chest X-ray, echocardiograms), and laboratory parameters, such as B-type natriuretic peptide. The primary endpoint of this study was the incidence of ADHF during the current hospitalization. Secondary endpoints included the length of hospital stay, hospital readmission, and overall mortality. Patient chart reviews were performed using the JHQVAMC Computerized Patient Record System (CPRS).

Statistical Analysis

Analysis was conducted with R Software. Pearson χ² and t tests were used to compare baseline demographics, length of stay, readmission, and mortality. Significance used was α = .05.

A retrospective chart review was performed on 389 veterans. Of the 389, 204 patients received at least 24 hours of PTZ, and 185 patients received CFP. The mean age in both groups was 75 years. Patients in the PTZ group were more likely to have been admitted with the diagnosis of pneumonia (105 vs 49, P < .001). However, 29 patients (15.7%) in the CFP group were admitted with a UTI diagnosis compared with 6 patients (2.9%) in the PTZ group (P < .001) and 62 patients (33.5%) in the CFP group were admitted with a SSTI diagnosis compared with 48 patients (23.5%) in the PTZ group (P = .03). Otherwise, there were no differences between other admitting diagnoses. Additionally, there was no difference in prior history of HF between groups (Table 1).

Twenty-five patients (12.3%) in the PTZ group and 4 patients (2.2%) in the CFP group were subsequently diagnosed with ADHF (P < .001). Hospital readmissions due to HF were higher in the PTZ group compared with the CFP group (11 vs 2, P = .02). Hospital readmission due to other causes was not significantly different between groups. Hospital readmission due to infection occurred in 18 patients who received PTZ and 25 who received CFP (8.8% vs 13.5%, P = .14). Hospital readmission due to any other indication occurred in 24 patients who received PTZ and 24 who received CFP (11.8% vs 13.0%, P = .72). There was no statistically significant difference in all-cause mortality during the associated admission or within 6 months of discharge between groups, with 59 total deaths in the PTZ group and 50 in the CFP group (28.9% vs 27.0%, P = .63).

There was no difference in length of stay outcomes between patients receiving PTZ compared with CFP. Twenty-eight patients in the PTZ group and 20 in the CFP group had a length of stay duration of < 3 days (13.7% vs 10.8%, P = .46). Seventy-three patients in the PTZ group and 76 in the CFP group had a length of stay duration of 4 to 6 days (36.3% vs 41.1%, P = .28). One hundred three patients in the PTZ group and 89 in the CFP group had a length of stay duration ≥ 7 days (50.5% vs 48.1%, P = .78). Table 2 includes a complete overview of primary and secondary endpoint results.

Discussion

The American Heart Association (AHA) lists PTZ as a medication that may cause or exacerbate HF, though no studies have identified a clear association between PTZ use and ADHF.⁴ Sodium restriction is consistently recommended as an important strategy for the prevention of ADHF. Accordingly, PTZ prescribing information and the AHA advise careful consideration with PTZ use in this patient population.^1,4

The specific mechanism responsible for the association of PTZ with cardiac-related adverse outcomes is unclear. It is easy to presume that the sodium content of PTZ is solely responsible; however, other antibiotic regimens not included as agents of concern by the AHA, such as meropenem, can approach similar overall daily sodium amounts.^4,7 Additionally, total sodium and volume can also be contributed by various IV medications and fluids. This study did not evaluate total sodium intake from all sources, but it is notable that this study identified a possible trend toward the risk of ADHF with PTZ use in a routine practice environment. It is reasonable to postulate additional intrinsic properties of PTZ may be contributing to the development of ADHF, such as its association with renal injury possibly resulting in increased fluid retainment and subsequent fluid volume overload.^1,2,4 Other hypothesized mechanisms may include those previously described, such as direct myocardial toxicity; negative inotropic, lusitropic, or chronotropic effects; exacerbating hypertension; and drug-drug interactions that limit the benefits of HF medications, although these have not been overtly associated with PTZ in the literature to date.^4,8

ADHF can present similarly to other acute pulmonary conditions, including pneumonia.^9,10 It is important to acknowledge the challenge this creates for diagnosticians to differentiate between these conditions rapidly and precisely. As a result, this patient population is likely at increased risk of IV antibiotic exposure. Other studies have identified worse outcomes in patients who receive potentially unwarranted IV antibiotics in patients with ADHF.^9,10 The results of this study further emphasize the importance of careful considerate antibiotic selection and overall avoidance of unnecessary antibiotic exposure to limit potential adverse outcomes.

Limitations

There are various limitations to this study. Firstly, no women were included due to the predominantly male population within the Veterans Health Administration system. Secondly, this study was retrospective in design and was therefore limited to the completeness and accuracy of the available data collected. Additionally, this study evaluated any ADHF episode during the associated hospitalization as the primary endpoint. The time to diagnosis of ADHF in relation to PTZ initiation was not evaluated, which may have helped better elucidate this possible association. Furthermore, while a significant statistical difference was identified, the smaller sample size may have limited the ability to accurately identify differences in lower event rate outcomes.

Conclusions

This study identifies an association between PTZ use and significant cardiac-related adverse outcomes, including increased incidence of ADHF and readmission due to HF exacerbation. While more research is needed to define the exact mechanisms by which PTZ may precipitate acute decompensation in patients with HF, it is judicious to consider close monitoring or the avoidance of PTZ when appropriate antibiotic alternatives are available in patients with a known history of HF.

Piperacillin/tazobactam (PTZ) is a combination IV antibiotic comprised of the semisynthetic antipseudomonal β-lactam, piperacillin sodium, and the β-lactamase inhibitor, tazobactam sodium.¹ PTZ is extensively prescribed in the hospital setting for a multitude of infections including but not limited to the US Food and Drug Administration–approved indications: intra-abdominal infection, skin and skin structure infection (SSTI), urinary tract infection (UTI), and pneumonia. Given its broad spectrum of activity and relative safety profile, PTZ is a mainstay of many empiric IV antibiotic regimens. The primary elimination pathway for PTZ is renal excretion, and dosage adjustments are recommended with reduced creatinine clearance. Additionally, PTZ use has been associated with acute renal injury and delayed renal recovery.^1-3

There are various mechanisms through which medications can contribute to acute decomopensated heart failure (ADHF).⁴ These mechanisms include direct cardiotoxicity; negative inotropic, lusitropic, or chronotropic effects; exacerbating hypertension; sodium loading; and drug-drug interactions that limit the benefits of heart failure (HF) medications. One potentially overlooked constituent of PTZ is the sodium content, with the standard formulation containing 65 mg of sodium per gram of piperacillin.^1-3 Furthermore, PTZ must be diluted in 50 to 150 mL of diluent, commonly 0.9% sodium chloride, which can contribute an additional 177 to 531 mg of sodium per dose. PTZ prescribing information advises caution for use in patients with decreased renal, hepatic, and/or cardiac function and notes that geriatric patients, particularly with HF, may be at risk of impaired natriuresis in the setting of large sodium doses.

It is estimated that roughly 6.2 million adults in the United States have HF and prevalence continues to rise.^5,6 Mortality rates after hospitalization due to HF are 20% to 25% at 1 year. Health care expenditures for the management of HF surpass $30 billion per year in the US, with most of this cost attributed to hospitalizations. Consequently, it is important to continue to identify and practice preventative strategies when managing patients with HF.

Methods

This single-center, retrospective, cohort study was conducted at James H. Quillen Veterans Affairs Medical Center (JHQVAMC) in Mountain Home, Tennessee, a 174-bed tertiary medical center. The purpose of this study was to compare the incidence of ADHF in patients who received PTZ vs cefepime (CFP). This project was reviewed by the JHQVAMC Institutional Review Board and deemed exempt as a clinical process improvement operations activity.

The antimicrobial stewardship team at JHQVAMC reviewed the use of PTZ in veterans between January 1, 2018, to December 31, 2019, and compared baseline demographics, history of HF, and outcomes in patients receiving analogous broad-spectrum empiric antibiotic therapy with CFP. Patients were included if they received at least 24 hours of PTZ or CFP. Patients were excluded if they were diagnosed with ADHF before initiation of antibiotic therapy. Patients with ADHF were identified by clinical diagnosis of ADHF documented by the treating clinician and reaffirmed by the study clinician during retrospective chart review. Clinical information used to determine ADHF included clinical presentation, imaging (ie, chest X-ray, echocardiograms), and laboratory parameters, such as B-type natriuretic peptide. The primary endpoint of this study was the incidence of ADHF during the current hospitalization. Secondary endpoints included the length of hospital stay, hospital readmission, and overall mortality. Patient chart reviews were performed using the JHQVAMC Computerized Patient Record System (CPRS).

Statistical Analysis

Analysis was conducted with R Software. Pearson χ² and t tests were used to compare baseline demographics, length of stay, readmission, and mortality. Significance used was α = .05.

A retrospective chart review was performed on 389 veterans. Of the 389, 204 patients received at least 24 hours of PTZ, and 185 patients received CFP. The mean age in both groups was 75 years. Patients in the PTZ group were more likely to have been admitted with the diagnosis of pneumonia (105 vs 49, P < .001). However, 29 patients (15.7%) in the CFP group were admitted with a UTI diagnosis compared with 6 patients (2.9%) in the PTZ group (P < .001) and 62 patients (33.5%) in the CFP group were admitted with a SSTI diagnosis compared with 48 patients (23.5%) in the PTZ group (P = .03). Otherwise, there were no differences between other admitting diagnoses. Additionally, there was no difference in prior history of HF between groups (Table 1).

Twenty-five patients (12.3%) in the PTZ group and 4 patients (2.2%) in the CFP group were subsequently diagnosed with ADHF (P < .001). Hospital readmissions due to HF were higher in the PTZ group compared with the CFP group (11 vs 2, P = .02). Hospital readmission due to other causes was not significantly different between groups. Hospital readmission due to infection occurred in 18 patients who received PTZ and 25 who received CFP (8.8% vs 13.5%, P = .14). Hospital readmission due to any other indication occurred in 24 patients who received PTZ and 24 who received CFP (11.8% vs 13.0%, P = .72). There was no statistically significant difference in all-cause mortality during the associated admission or within 6 months of discharge between groups, with 59 total deaths in the PTZ group and 50 in the CFP group (28.9% vs 27.0%, P = .63).

There was no difference in length of stay outcomes between patients receiving PTZ compared with CFP. Twenty-eight patients in the PTZ group and 20 in the CFP group had a length of stay duration of < 3 days (13.7% vs 10.8%, P = .46). Seventy-three patients in the PTZ group and 76 in the CFP group had a length of stay duration of 4 to 6 days (36.3% vs 41.1%, P = .28). One hundred three patients in the PTZ group and 89 in the CFP group had a length of stay duration ≥ 7 days (50.5% vs 48.1%, P = .78). Table 2 includes a complete overview of primary and secondary endpoint results.

Discussion

The American Heart Association (AHA) lists PTZ as a medication that may cause or exacerbate HF, though no studies have identified a clear association between PTZ use and ADHF.⁴ Sodium restriction is consistently recommended as an important strategy for the prevention of ADHF. Accordingly, PTZ prescribing information and the AHA advise careful consideration with PTZ use in this patient population.^1,4

The specific mechanism responsible for the association of PTZ with cardiac-related adverse outcomes is unclear. It is easy to presume that the sodium content of PTZ is solely responsible; however, other antibiotic regimens not included as agents of concern by the AHA, such as meropenem, can approach similar overall daily sodium amounts.^4,7 Additionally, total sodium and volume can also be contributed by various IV medications and fluids. This study did not evaluate total sodium intake from all sources, but it is notable that this study identified a possible trend toward the risk of ADHF with PTZ use in a routine practice environment. It is reasonable to postulate additional intrinsic properties of PTZ may be contributing to the development of ADHF, such as its association with renal injury possibly resulting in increased fluid retainment and subsequent fluid volume overload.^1,2,4 Other hypothesized mechanisms may include those previously described, such as direct myocardial toxicity; negative inotropic, lusitropic, or chronotropic effects; exacerbating hypertension; and drug-drug interactions that limit the benefits of HF medications, although these have not been overtly associated with PTZ in the literature to date.^4,8

ADHF can present similarly to other acute pulmonary conditions, including pneumonia.^9,10 It is important to acknowledge the challenge this creates for diagnosticians to differentiate between these conditions rapidly and precisely. As a result, this patient population is likely at increased risk of IV antibiotic exposure. Other studies have identified worse outcomes in patients who receive potentially unwarranted IV antibiotics in patients with ADHF.^9,10 The results of this study further emphasize the importance of careful considerate antibiotic selection and overall avoidance of unnecessary antibiotic exposure to limit potential adverse outcomes.

Limitations

There are various limitations to this study. Firstly, no women were included due to the predominantly male population within the Veterans Health Administration system. Secondly, this study was retrospective in design and was therefore limited to the completeness and accuracy of the available data collected. Additionally, this study evaluated any ADHF episode during the associated hospitalization as the primary endpoint. The time to diagnosis of ADHF in relation to PTZ initiation was not evaluated, which may have helped better elucidate this possible association. Furthermore, while a significant statistical difference was identified, the smaller sample size may have limited the ability to accurately identify differences in lower event rate outcomes.

Conclusions

This study identifies an association between PTZ use and significant cardiac-related adverse outcomes, including increased incidence of ADHF and readmission due to HF exacerbation. While more research is needed to define the exact mechanisms by which PTZ may precipitate acute decompensation in patients with HF, it is judicious to consider close monitoring or the avoidance of PTZ when appropriate antibiotic alternatives are available in patients with a known history of HF.

Piperacillin/tazobactam (PTZ) is a combination IV antibiotic comprised of the semisynthetic antipseudomonal β-lactam, piperacillin sodium, and the β-lactamase inhibitor, tazobactam sodium.¹ PTZ is extensively prescribed in the hospital setting for a multitude of infections including but not limited to the US Food and Drug Administration–approved indications: intra-abdominal infection, skin and skin structure infection (SSTI), urinary tract infection (UTI), and pneumonia. Given its broad spectrum of activity and relative safety profile, PTZ is a mainstay of many empiric IV antibiotic regimens. The primary elimination pathway for PTZ is renal excretion, and dosage adjustments are recommended with reduced creatinine clearance. Additionally, PTZ use has been associated with acute renal injury and delayed renal recovery.^1-3

There are various mechanisms through which medications can contribute to acute decomopensated heart failure (ADHF).⁴ These mechanisms include direct cardiotoxicity; negative inotropic, lusitropic, or chronotropic effects; exacerbating hypertension; sodium loading; and drug-drug interactions that limit the benefits of heart failure (HF) medications. One potentially overlooked constituent of PTZ is the sodium content, with the standard formulation containing 65 mg of sodium per gram of piperacillin.^1-3 Furthermore, PTZ must be diluted in 50 to 150 mL of diluent, commonly 0.9% sodium chloride, which can contribute an additional 177 to 531 mg of sodium per dose. PTZ prescribing information advises caution for use in patients with decreased renal, hepatic, and/or cardiac function and notes that geriatric patients, particularly with HF, may be at risk of impaired natriuresis in the setting of large sodium doses.

It is estimated that roughly 6.2 million adults in the United States have HF and prevalence continues to rise.^5,6 Mortality rates after hospitalization due to HF are 20% to 25% at 1 year. Health care expenditures for the management of HF surpass $30 billion per year in the US, with most of this cost attributed to hospitalizations. Consequently, it is important to continue to identify and practice preventative strategies when managing patients with HF.

Methods

This single-center, retrospective, cohort study was conducted at James H. Quillen Veterans Affairs Medical Center (JHQVAMC) in Mountain Home, Tennessee, a 174-bed tertiary medical center. The purpose of this study was to compare the incidence of ADHF in patients who received PTZ vs cefepime (CFP). This project was reviewed by the JHQVAMC Institutional Review Board and deemed exempt as a clinical process improvement operations activity.

The antimicrobial stewardship team at JHQVAMC reviewed the use of PTZ in veterans between January 1, 2018, to December 31, 2019, and compared baseline demographics, history of HF, and outcomes in patients receiving analogous broad-spectrum empiric antibiotic therapy with CFP. Patients were included if they received at least 24 hours of PTZ or CFP. Patients were excluded if they were diagnosed with ADHF before initiation of antibiotic therapy. Patients with ADHF were identified by clinical diagnosis of ADHF documented by the treating clinician and reaffirmed by the study clinician during retrospective chart review. Clinical information used to determine ADHF included clinical presentation, imaging (ie, chest X-ray, echocardiograms), and laboratory parameters, such as B-type natriuretic peptide. The primary endpoint of this study was the incidence of ADHF during the current hospitalization. Secondary endpoints included the length of hospital stay, hospital readmission, and overall mortality. Patient chart reviews were performed using the JHQVAMC Computerized Patient Record System (CPRS).

Statistical Analysis

Analysis was conducted with R Software. Pearson χ² and t tests were used to compare baseline demographics, length of stay, readmission, and mortality. Significance used was α = .05.

A retrospective chart review was performed on 389 veterans. Of the 389, 204 patients received at least 24 hours of PTZ, and 185 patients received CFP. The mean age in both groups was 75 years. Patients in the PTZ group were more likely to have been admitted with the diagnosis of pneumonia (105 vs 49, P < .001). However, 29 patients (15.7%) in the CFP group were admitted with a UTI diagnosis compared with 6 patients (2.9%) in the PTZ group (P < .001) and 62 patients (33.5%) in the CFP group were admitted with a SSTI diagnosis compared with 48 patients (23.5%) in the PTZ group (P = .03). Otherwise, there were no differences between other admitting diagnoses. Additionally, there was no difference in prior history of HF between groups (Table 1).

Twenty-five patients (12.3%) in the PTZ group and 4 patients (2.2%) in the CFP group were subsequently diagnosed with ADHF (P < .001). Hospital readmissions due to HF were higher in the PTZ group compared with the CFP group (11 vs 2, P = .02). Hospital readmission due to other causes was not significantly different between groups. Hospital readmission due to infection occurred in 18 patients who received PTZ and 25 who received CFP (8.8% vs 13.5%, P = .14). Hospital readmission due to any other indication occurred in 24 patients who received PTZ and 24 who received CFP (11.8% vs 13.0%, P = .72). There was no statistically significant difference in all-cause mortality during the associated admission or within 6 months of discharge between groups, with 59 total deaths in the PTZ group and 50 in the CFP group (28.9% vs 27.0%, P = .63).

There was no difference in length of stay outcomes between patients receiving PTZ compared with CFP. Twenty-eight patients in the PTZ group and 20 in the CFP group had a length of stay duration of < 3 days (13.7% vs 10.8%, P = .46). Seventy-three patients in the PTZ group and 76 in the CFP group had a length of stay duration of 4 to 6 days (36.3% vs 41.1%, P = .28). One hundred three patients in the PTZ group and 89 in the CFP group had a length of stay duration ≥ 7 days (50.5% vs 48.1%, P = .78). Table 2 includes a complete overview of primary and secondary endpoint results.

Discussion

The American Heart Association (AHA) lists PTZ as a medication that may cause or exacerbate HF, though no studies have identified a clear association between PTZ use and ADHF.⁴ Sodium restriction is consistently recommended as an important strategy for the prevention of ADHF. Accordingly, PTZ prescribing information and the AHA advise careful consideration with PTZ use in this patient population.^1,4

The specific mechanism responsible for the association of PTZ with cardiac-related adverse outcomes is unclear. It is easy to presume that the sodium content of PTZ is solely responsible; however, other antibiotic regimens not included as agents of concern by the AHA, such as meropenem, can approach similar overall daily sodium amounts.^4,7 Additionally, total sodium and volume can also be contributed by various IV medications and fluids. This study did not evaluate total sodium intake from all sources, but it is notable that this study identified a possible trend toward the risk of ADHF with PTZ use in a routine practice environment. It is reasonable to postulate additional intrinsic properties of PTZ may be contributing to the development of ADHF, such as its association with renal injury possibly resulting in increased fluid retainment and subsequent fluid volume overload.^1,2,4 Other hypothesized mechanisms may include those previously described, such as direct myocardial toxicity; negative inotropic, lusitropic, or chronotropic effects; exacerbating hypertension; and drug-drug interactions that limit the benefits of HF medications, although these have not been overtly associated with PTZ in the literature to date.^4,8

ADHF can present similarly to other acute pulmonary conditions, including pneumonia.^9,10 It is important to acknowledge the challenge this creates for diagnosticians to differentiate between these conditions rapidly and precisely. As a result, this patient population is likely at increased risk of IV antibiotic exposure. Other studies have identified worse outcomes in patients who receive potentially unwarranted IV antibiotics in patients with ADHF.^9,10 The results of this study further emphasize the importance of careful considerate antibiotic selection and overall avoidance of unnecessary antibiotic exposure to limit potential adverse outcomes.

Limitations

There are various limitations to this study. Firstly, no women were included due to the predominantly male population within the Veterans Health Administration system. Secondly, this study was retrospective in design and was therefore limited to the completeness and accuracy of the available data collected. Additionally, this study evaluated any ADHF episode during the associated hospitalization as the primary endpoint. The time to diagnosis of ADHF in relation to PTZ initiation was not evaluated, which may have helped better elucidate this possible association. Furthermore, while a significant statistical difference was identified, the smaller sample size may have limited the ability to accurately identify differences in lower event rate outcomes.

Conclusions

This study identifies an association between PTZ use and significant cardiac-related adverse outcomes, including increased incidence of ADHF and readmission due to HF exacerbation. While more research is needed to define the exact mechanisms by which PTZ may precipitate acute decompensation in patients with HF, it is judicious to consider close monitoring or the avoidance of PTZ when appropriate antibiotic alternatives are available in patients with a known history of HF.

This transcript has been edited for clarity.

I’ve been spending time recently reflecting on the biggest developments from last year. I have to say that the breakthrough of the year, based on the amount of data presented and the importance of the data, is chemotherapy. I never thought I would say that. Many folks have tried to relegate chemotherapy to the museum, but last year it came to the forefront.

Let’s start with neoadjuvant therapy. We now have multiple drug approvals for giving a checkpoint inhibitor and neoadjuvant therapy in what I would say is a new standard of care for patients with locally advanced lung cancers who are candidates for surgery. In all those trials, there was a clear improvement in progression-free survival by adding a checkpoint inhibitor to chemotherapy. The cornerstone of this regimen is chemotherapy.

What about adjuvant therapy? I think one of the most astounding pieces of data last year was in the adjuvant realm. In the trial comparing adjuvant osimertinib with placebo in patients with EGFR-mutant disease, patients who received chemotherapy in addition to osimertinib had a 7% improvement in 5-year survival. Patients who had placebo, who got chemotherapy vs didn’t, had a 9% improvement in 5-year survival. Those are huge numbers for that kind of metric, and it happened with chemotherapy.

What about targeted therapies? Again, I think people were astounded that, by adding chemotherapy to osimertinib compared with osimertinib alone, there was a 9-month improvement overall in progression-free survival. I think in the presentation of the data that has been made, the most remarkable piece of data is that, in patients with brain metastases, chemotherapy on top of osimertinib improved progression-free survival. Not only did it improve progression-free survival, but it did it with brain metastases, where people think it just doesn’t help at all.

What about other, newer agents with chemotherapy? Amivantamab, I would say, has hitched itself to chemotherapy. A trial in EGFR exon 20 compared chemo to amivantamab plus chemotherapy. There again, chemo is the common denominator. Amivantamab added approximately 5 months of improved progression-free survival. Again, chemo was used. In adjuvant, neoadjuvant, and targeted therapies, chemotherapy adds.

What about the second line? I think everybody was very disappointed when second-line sotorasib gave a very tiny amount of progression-free survival improvement over docetaxel. I think we all want more for our patients than we can deliver with docetaxel. The roughly 5-week improvement seen with sotorasib was one that raised a question about the place of sotorasib in this setting.

Clearly, we’ve all seen patients have an excellent result with sotorasib as an additional option for treating patients with long progression-free survival, high rates of response, and good tolerability even at the 960 mg dose. But in the randomized trial, it wasn’t better than docetaxel. Again, I think we were disappointed with tusamitamab ravtansine in that it could not beat docetaxel either. I think the idea here is that chemo still has a huge place and still remains the treatment that we have to beat.

We’re all very excited about the antibody-drug conjugates and I think everybody sees them as another advance. Many folks have said that they are just a more precise way of delivering chemotherapy, and when you look at the side effects, it supports that — they’re largely side effects of chemotherapy with these drugs across the board. Also, when you look at the patterns of resistance, the resistance really isn’t a resistance to the targeted therapy; it’s a resistance to chemotherapy more than anything else.

So we’re happy that the antibody-drug conjugates are available and we were disappointed with tusamitamab ravtansine because we thought that it could beat docetaxel. But in truth, it didn’t, and unfortunately, that pivotal trial led to the end of the entire development program for that agent, as stated in a press release.

The molecule or treatment of the year is chemotherapy — added to targeted therapies, used with immunotherapy, and now attached to antibodies as part of antibody-drug conjugates. I think it remains, more than any one treatment, a very effective treatment for patients and deserves to be used.

There are a lot of choices here. I think you have to be very careful to choose wisely, and you also have to be careful because chemotherapy has side effects. The nice thing is that many of those side effects can be ameliorated. We have to make sure that we use all the supportive medications we can.

Who would have thought that chemotherapy would be the treatment of the year in 2023 for lung cancers?
 

Dr. Kris is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York City. He disclosed ties with AstraZeneca, Roche/Genentech, Ariad Pharmaceuticals, Pfizer Inc, and PUMA.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

I’ve been spending time recently reflecting on the biggest developments from last year. I have to say that the breakthrough of the year, based on the amount of data presented and the importance of the data, is chemotherapy. I never thought I would say that. Many folks have tried to relegate chemotherapy to the museum, but last year it came to the forefront.

Let’s start with neoadjuvant therapy. We now have multiple drug approvals for giving a checkpoint inhibitor and neoadjuvant therapy in what I would say is a new standard of care for patients with locally advanced lung cancers who are candidates for surgery. In all those trials, there was a clear improvement in progression-free survival by adding a checkpoint inhibitor to chemotherapy. The cornerstone of this regimen is chemotherapy.

What about adjuvant therapy? I think one of the most astounding pieces of data last year was in the adjuvant realm. In the trial comparing adjuvant osimertinib with placebo in patients with EGFR-mutant disease, patients who received chemotherapy in addition to osimertinib had a 7% improvement in 5-year survival. Patients who had placebo, who got chemotherapy vs didn’t, had a 9% improvement in 5-year survival. Those are huge numbers for that kind of metric, and it happened with chemotherapy.

What about targeted therapies? Again, I think people were astounded that, by adding chemotherapy to osimertinib compared with osimertinib alone, there was a 9-month improvement overall in progression-free survival. I think in the presentation of the data that has been made, the most remarkable piece of data is that, in patients with brain metastases, chemotherapy on top of osimertinib improved progression-free survival. Not only did it improve progression-free survival, but it did it with brain metastases, where people think it just doesn’t help at all.

What about other, newer agents with chemotherapy? Amivantamab, I would say, has hitched itself to chemotherapy. A trial in EGFR exon 20 compared chemo to amivantamab plus chemotherapy. There again, chemo is the common denominator. Amivantamab added approximately 5 months of improved progression-free survival. Again, chemo was used. In adjuvant, neoadjuvant, and targeted therapies, chemotherapy adds.

What about the second line? I think everybody was very disappointed when second-line sotorasib gave a very tiny amount of progression-free survival improvement over docetaxel. I think we all want more for our patients than we can deliver with docetaxel. The roughly 5-week improvement seen with sotorasib was one that raised a question about the place of sotorasib in this setting.

Clearly, we’ve all seen patients have an excellent result with sotorasib as an additional option for treating patients with long progression-free survival, high rates of response, and good tolerability even at the 960 mg dose. But in the randomized trial, it wasn’t better than docetaxel. Again, I think we were disappointed with tusamitamab ravtansine in that it could not beat docetaxel either. I think the idea here is that chemo still has a huge place and still remains the treatment that we have to beat.

We’re all very excited about the antibody-drug conjugates and I think everybody sees them as another advance. Many folks have said that they are just a more precise way of delivering chemotherapy, and when you look at the side effects, it supports that — they’re largely side effects of chemotherapy with these drugs across the board. Also, when you look at the patterns of resistance, the resistance really isn’t a resistance to the targeted therapy; it’s a resistance to chemotherapy more than anything else.

So we’re happy that the antibody-drug conjugates are available and we were disappointed with tusamitamab ravtansine because we thought that it could beat docetaxel. But in truth, it didn’t, and unfortunately, that pivotal trial led to the end of the entire development program for that agent, as stated in a press release.

The molecule or treatment of the year is chemotherapy — added to targeted therapies, used with immunotherapy, and now attached to antibodies as part of antibody-drug conjugates. I think it remains, more than any one treatment, a very effective treatment for patients and deserves to be used.

There are a lot of choices here. I think you have to be very careful to choose wisely, and you also have to be careful because chemotherapy has side effects. The nice thing is that many of those side effects can be ameliorated. We have to make sure that we use all the supportive medications we can.

Who would have thought that chemotherapy would be the treatment of the year in 2023 for lung cancers?
 

Dr. Kris is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York City. He disclosed ties with AstraZeneca, Roche/Genentech, Ariad Pharmaceuticals, Pfizer Inc, and PUMA.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

I’ve been spending time recently reflecting on the biggest developments from last year. I have to say that the breakthrough of the year, based on the amount of data presented and the importance of the data, is chemotherapy. I never thought I would say that. Many folks have tried to relegate chemotherapy to the museum, but last year it came to the forefront.

Let’s start with neoadjuvant therapy. We now have multiple drug approvals for giving a checkpoint inhibitor and neoadjuvant therapy in what I would say is a new standard of care for patients with locally advanced lung cancers who are candidates for surgery. In all those trials, there was a clear improvement in progression-free survival by adding a checkpoint inhibitor to chemotherapy. The cornerstone of this regimen is chemotherapy.

What about adjuvant therapy? I think one of the most astounding pieces of data last year was in the adjuvant realm. In the trial comparing adjuvant osimertinib with placebo in patients with EGFR-mutant disease, patients who received chemotherapy in addition to osimertinib had a 7% improvement in 5-year survival. Patients who had placebo, who got chemotherapy vs didn’t, had a 9% improvement in 5-year survival. Those are huge numbers for that kind of metric, and it happened with chemotherapy.

What about targeted therapies? Again, I think people were astounded that, by adding chemotherapy to osimertinib compared with osimertinib alone, there was a 9-month improvement overall in progression-free survival. I think in the presentation of the data that has been made, the most remarkable piece of data is that, in patients with brain metastases, chemotherapy on top of osimertinib improved progression-free survival. Not only did it improve progression-free survival, but it did it with brain metastases, where people think it just doesn’t help at all.

What about other, newer agents with chemotherapy? Amivantamab, I would say, has hitched itself to chemotherapy. A trial in EGFR exon 20 compared chemo to amivantamab plus chemotherapy. There again, chemo is the common denominator. Amivantamab added approximately 5 months of improved progression-free survival. Again, chemo was used. In adjuvant, neoadjuvant, and targeted therapies, chemotherapy adds.

What about the second line? I think everybody was very disappointed when second-line sotorasib gave a very tiny amount of progression-free survival improvement over docetaxel. I think we all want more for our patients than we can deliver with docetaxel. The roughly 5-week improvement seen with sotorasib was one that raised a question about the place of sotorasib in this setting.

Clearly, we’ve all seen patients have an excellent result with sotorasib as an additional option for treating patients with long progression-free survival, high rates of response, and good tolerability even at the 960 mg dose. But in the randomized trial, it wasn’t better than docetaxel. Again, I think we were disappointed with tusamitamab ravtansine in that it could not beat docetaxel either. I think the idea here is that chemo still has a huge place and still remains the treatment that we have to beat.

We’re all very excited about the antibody-drug conjugates and I think everybody sees them as another advance. Many folks have said that they are just a more precise way of delivering chemotherapy, and when you look at the side effects, it supports that — they’re largely side effects of chemotherapy with these drugs across the board. Also, when you look at the patterns of resistance, the resistance really isn’t a resistance to the targeted therapy; it’s a resistance to chemotherapy more than anything else.

So we’re happy that the antibody-drug conjugates are available and we were disappointed with tusamitamab ravtansine because we thought that it could beat docetaxel. But in truth, it didn’t, and unfortunately, that pivotal trial led to the end of the entire development program for that agent, as stated in a press release.

The molecule or treatment of the year is chemotherapy — added to targeted therapies, used with immunotherapy, and now attached to antibodies as part of antibody-drug conjugates. I think it remains, more than any one treatment, a very effective treatment for patients and deserves to be used.

There are a lot of choices here. I think you have to be very careful to choose wisely, and you also have to be careful because chemotherapy has side effects. The nice thing is that many of those side effects can be ameliorated. We have to make sure that we use all the supportive medications we can.

Who would have thought that chemotherapy would be the treatment of the year in 2023 for lung cancers?
 

Dr. Kris is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York City. He disclosed ties with AstraZeneca, Roche/Genentech, Ariad Pharmaceuticals, Pfizer Inc, and PUMA.

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — For some people, acne carries a one-two punch. First, they experience acne that is significant enough to decrease their quality of life, followed by scarring that can last a lifetime. For those patients, dermatologists have several options: Subcision to lift the depression of the scar, laser treatment to lower the height of scar tissue, and injections to fill scars.

“In my practice, I find that these [acne scars] are probably the hardest things to treat. But along the way, I created a protocol that I would love to share with you today,” Robyn Siperstein, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.

Dr. Siperstein starts by identifying the type of acne scar — rolling scars, boxcar scars, or ice pick scars. Rolling scars tend to be shallower with no sharp edges; boxcar scars are deeper, more defined round or oval depressions; and ice pick scars, as the name suggests, look like someone stuck tiny ice picks into the skin, leaving a sunken or pitted appearance.

“It’s really important to categorize so that we know which ones are going to be effectively treated with different modalities and which ones aren’t, so that we can give our patients realistic expectations,” said Dr. Siperstein, a cosmetic dermatologist in private practice in Boca Raton, Florida, and a clinical affiliate associate professor of dermatology at Florida Atlantic University, Boca Raton.

“There’s not going to be one treatment that’s right for everything,” she said. Different approaches may be required even for the same patient because some people present with all three types of acne scars, she added.

Combining Treatments

When it comes to injecting dermal fillers into acne scars to lift the depressed areas, the US Food and Drug Administration approved a filler with polymethyl methacrylate filler and bovine collagen (Bellafill) for this indication (moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21) in 2015. “And off-label, I use hyaluronic acid in my practice,” Dr. Siperstein said. Each filler “probably works a little bit better or differently on different types of scars.”

For rolling scars, she recommends hyaluronic acid (HA) dermal filler for everyone. “Of course, this is my opinion.” She was also a lead investigator in a randomized, placebo-controlled split-face study comparing HA filler with saline for correcting atrophic facial scars in 15 patients. The HA filler emerged superior, although there were some improvements with saline.

In her clinical experience, patients are happy with the results and ask, “Why didn’t the last four doctors do this?”

Boxcar scars are more challenging to fill with HA. In some cases, Dr. Siperstein is able to raise the depressed portion of the scar, but some of the vertical edges remain. In this scenario, she might combine treatments. Laser resurfacing, for example, might help convert boxcar scars into rolling scars, which then can be filled more successfully.

“Ice pick scars are tough,” Dr. Siperstein said. A punch removal technique can work in some cases, or she might try the “cross technique.” This involves placing acetic acid inside the scar using a Q-tip. “You have to be really careful,” she added, “because if you get it around the edges, it’s actually going to make the scar bigger.”
 

Choosing the Right Candidates

Selecting the right candidate for HA treatment of acne scars is essential. Dr. Siperstein shared the example of a lifeguard who had prominent acne scarring down the center of his chest. “He was embarrassed to go to the beach and take off his shirt. He said he felt like he had bullet holes in his chest.”

One month following treatment, “he had a really nice improvement, and now he feels really comfortable,” she said.

Some dermatologists might be reluctant to consider HA fillers for acne scarring because there is a misconception that HA is short-acting, lasting 6 months to 1 year before the effect wears off. That impression can persist from company-sponsored studies that limit follow-up to 6 months or 1 year “to get their drug to market,” she noted.

Also adding to this impression is that HA fillers in wrinkles may not last as long. Dr. Siperstein explained that wrinkles on the face are dynamic and constantly moving. In contrast, acne scars experience less movement, which helps the HA last longer. There is MRI evidence that shows HA fillers last over 2 years in the face, she added.

One tip to predict how well an acne scar might respond to filler injections is to squeeze it and look for the “dimple sign.” If the floor of the scar lifts up when squeezed, “we know that they’ll be a good candidate for hyaluronic acid filler.” Another tip is to inject HA in a retrograde technique high up in the skin. Inject tiny amounts — microdroplets — of the HA filler high on the dermis, she advised.

Deeper injections run the risk of raising the entire scar instead of filling it, she added.

Like many dermatologic procedures, before and after photos are essential to demonstrate improvements, Dr. Siperstein pointed out. Patients are often skeptical. “This happens a lot with acne scar patients. They’ve been to a million places that have promised results, they have not gotten them, and they are frustrated.”

Acne scars can result from picking, inflammation, or treatment. “This is what we see all day in clinic,” Dr. Siperstein said. “Somebody who had to undergo Accutane treatment but unfortunately is left with holes. This is a huge psychological burden on our patients,” she said, describing a younger patient who had scarring, which “led to depression — it was ruining his life.”

“His mom was willing to do whatever it took. And I said, You know what, I think filler will be enough,” Dr. Siperstein said. She counseled them that treatment would not make the scars disappear completely. But patients used to 10% improvements are very happy when their acne scars look 80% or 90% better, she added.

Dr. Siperstein received grant or research support and is a member of the speakers bureau for Allergan and Galderma. She is also a consultant/advisory board member for Allergan.
 

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — For some people, acne carries a one-two punch. First, they experience acne that is significant enough to decrease their quality of life, followed by scarring that can last a lifetime. For those patients, dermatologists have several options: Subcision to lift the depression of the scar, laser treatment to lower the height of scar tissue, and injections to fill scars.

“In my practice, I find that these [acne scars] are probably the hardest things to treat. But along the way, I created a protocol that I would love to share with you today,” Robyn Siperstein, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.

Dr. Siperstein starts by identifying the type of acne scar — rolling scars, boxcar scars, or ice pick scars. Rolling scars tend to be shallower with no sharp edges; boxcar scars are deeper, more defined round or oval depressions; and ice pick scars, as the name suggests, look like someone stuck tiny ice picks into the skin, leaving a sunken or pitted appearance.

“It’s really important to categorize so that we know which ones are going to be effectively treated with different modalities and which ones aren’t, so that we can give our patients realistic expectations,” said Dr. Siperstein, a cosmetic dermatologist in private practice in Boca Raton, Florida, and a clinical affiliate associate professor of dermatology at Florida Atlantic University, Boca Raton.

“There’s not going to be one treatment that’s right for everything,” she said. Different approaches may be required even for the same patient because some people present with all three types of acne scars, she added.

Combining Treatments

When it comes to injecting dermal fillers into acne scars to lift the depressed areas, the US Food and Drug Administration approved a filler with polymethyl methacrylate filler and bovine collagen (Bellafill) for this indication (moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21) in 2015. “And off-label, I use hyaluronic acid in my practice,” Dr. Siperstein said. Each filler “probably works a little bit better or differently on different types of scars.”

For rolling scars, she recommends hyaluronic acid (HA) dermal filler for everyone. “Of course, this is my opinion.” She was also a lead investigator in a randomized, placebo-controlled split-face study comparing HA filler with saline for correcting atrophic facial scars in 15 patients. The HA filler emerged superior, although there were some improvements with saline.

In her clinical experience, patients are happy with the results and ask, “Why didn’t the last four doctors do this?”

Boxcar scars are more challenging to fill with HA. In some cases, Dr. Siperstein is able to raise the depressed portion of the scar, but some of the vertical edges remain. In this scenario, she might combine treatments. Laser resurfacing, for example, might help convert boxcar scars into rolling scars, which then can be filled more successfully.

“Ice pick scars are tough,” Dr. Siperstein said. A punch removal technique can work in some cases, or she might try the “cross technique.” This involves placing acetic acid inside the scar using a Q-tip. “You have to be really careful,” she added, “because if you get it around the edges, it’s actually going to make the scar bigger.”
 

Choosing the Right Candidates

Selecting the right candidate for HA treatment of acne scars is essential. Dr. Siperstein shared the example of a lifeguard who had prominent acne scarring down the center of his chest. “He was embarrassed to go to the beach and take off his shirt. He said he felt like he had bullet holes in his chest.”

One month following treatment, “he had a really nice improvement, and now he feels really comfortable,” she said.

Some dermatologists might be reluctant to consider HA fillers for acne scarring because there is a misconception that HA is short-acting, lasting 6 months to 1 year before the effect wears off. That impression can persist from company-sponsored studies that limit follow-up to 6 months or 1 year “to get their drug to market,” she noted.

Also adding to this impression is that HA fillers in wrinkles may not last as long. Dr. Siperstein explained that wrinkles on the face are dynamic and constantly moving. In contrast, acne scars experience less movement, which helps the HA last longer. There is MRI evidence that shows HA fillers last over 2 years in the face, she added.

One tip to predict how well an acne scar might respond to filler injections is to squeeze it and look for the “dimple sign.” If the floor of the scar lifts up when squeezed, “we know that they’ll be a good candidate for hyaluronic acid filler.” Another tip is to inject HA in a retrograde technique high up in the skin. Inject tiny amounts — microdroplets — of the HA filler high on the dermis, she advised.

Deeper injections run the risk of raising the entire scar instead of filling it, she added.

Like many dermatologic procedures, before and after photos are essential to demonstrate improvements, Dr. Siperstein pointed out. Patients are often skeptical. “This happens a lot with acne scar patients. They’ve been to a million places that have promised results, they have not gotten them, and they are frustrated.”

Acne scars can result from picking, inflammation, or treatment. “This is what we see all day in clinic,” Dr. Siperstein said. “Somebody who had to undergo Accutane treatment but unfortunately is left with holes. This is a huge psychological burden on our patients,” she said, describing a younger patient who had scarring, which “led to depression — it was ruining his life.”

“His mom was willing to do whatever it took. And I said, You know what, I think filler will be enough,” Dr. Siperstein said. She counseled them that treatment would not make the scars disappear completely. But patients used to 10% improvements are very happy when their acne scars look 80% or 90% better, she added.

Dr. Siperstein received grant or research support and is a member of the speakers bureau for Allergan and Galderma. She is also a consultant/advisory board member for Allergan.
 

A version of this article appeared on Medscape.com.

ORLANDO, FLORIDA — For some people, acne carries a one-two punch. First, they experience acne that is significant enough to decrease their quality of life, followed by scarring that can last a lifetime. For those patients, dermatologists have several options: Subcision to lift the depression of the scar, laser treatment to lower the height of scar tissue, and injections to fill scars.

“In my practice, I find that these [acne scars] are probably the hardest things to treat. But along the way, I created a protocol that I would love to share with you today,” Robyn Siperstein, MD, said at the annual ODAC Dermatology, Aesthetic & Surgical Conference.

Dr. Siperstein starts by identifying the type of acne scar — rolling scars, boxcar scars, or ice pick scars. Rolling scars tend to be shallower with no sharp edges; boxcar scars are deeper, more defined round or oval depressions; and ice pick scars, as the name suggests, look like someone stuck tiny ice picks into the skin, leaving a sunken or pitted appearance.

“It’s really important to categorize so that we know which ones are going to be effectively treated with different modalities and which ones aren’t, so that we can give our patients realistic expectations,” said Dr. Siperstein, a cosmetic dermatologist in private practice in Boca Raton, Florida, and a clinical affiliate associate professor of dermatology at Florida Atlantic University, Boca Raton.

“There’s not going to be one treatment that’s right for everything,” she said. Different approaches may be required even for the same patient because some people present with all three types of acne scars, she added.

Combining Treatments

When it comes to injecting dermal fillers into acne scars to lift the depressed areas, the US Food and Drug Administration approved a filler with polymethyl methacrylate filler and bovine collagen (Bellafill) for this indication (moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over age 21) in 2015. “And off-label, I use hyaluronic acid in my practice,” Dr. Siperstein said. Each filler “probably works a little bit better or differently on different types of scars.”

For rolling scars, she recommends hyaluronic acid (HA) dermal filler for everyone. “Of course, this is my opinion.” She was also a lead investigator in a randomized, placebo-controlled split-face study comparing HA filler with saline for correcting atrophic facial scars in 15 patients. The HA filler emerged superior, although there were some improvements with saline.

In her clinical experience, patients are happy with the results and ask, “Why didn’t the last four doctors do this?”

Boxcar scars are more challenging to fill with HA. In some cases, Dr. Siperstein is able to raise the depressed portion of the scar, but some of the vertical edges remain. In this scenario, she might combine treatments. Laser resurfacing, for example, might help convert boxcar scars into rolling scars, which then can be filled more successfully.

“Ice pick scars are tough,” Dr. Siperstein said. A punch removal technique can work in some cases, or she might try the “cross technique.” This involves placing acetic acid inside the scar using a Q-tip. “You have to be really careful,” she added, “because if you get it around the edges, it’s actually going to make the scar bigger.”
 

Choosing the Right Candidates

Selecting the right candidate for HA treatment of acne scars is essential. Dr. Siperstein shared the example of a lifeguard who had prominent acne scarring down the center of his chest. “He was embarrassed to go to the beach and take off his shirt. He said he felt like he had bullet holes in his chest.”

One month following treatment, “he had a really nice improvement, and now he feels really comfortable,” she said.

Some dermatologists might be reluctant to consider HA fillers for acne scarring because there is a misconception that HA is short-acting, lasting 6 months to 1 year before the effect wears off. That impression can persist from company-sponsored studies that limit follow-up to 6 months or 1 year “to get their drug to market,” she noted.

Also adding to this impression is that HA fillers in wrinkles may not last as long. Dr. Siperstein explained that wrinkles on the face are dynamic and constantly moving. In contrast, acne scars experience less movement, which helps the HA last longer. There is MRI evidence that shows HA fillers last over 2 years in the face, she added.

One tip to predict how well an acne scar might respond to filler injections is to squeeze it and look for the “dimple sign.” If the floor of the scar lifts up when squeezed, “we know that they’ll be a good candidate for hyaluronic acid filler.” Another tip is to inject HA in a retrograde technique high up in the skin. Inject tiny amounts — microdroplets — of the HA filler high on the dermis, she advised.

Deeper injections run the risk of raising the entire scar instead of filling it, she added.

Like many dermatologic procedures, before and after photos are essential to demonstrate improvements, Dr. Siperstein pointed out. Patients are often skeptical. “This happens a lot with acne scar patients. They’ve been to a million places that have promised results, they have not gotten them, and they are frustrated.”

Acne scars can result from picking, inflammation, or treatment. “This is what we see all day in clinic,” Dr. Siperstein said. “Somebody who had to undergo Accutane treatment but unfortunately is left with holes. This is a huge psychological burden on our patients,” she said, describing a younger patient who had scarring, which “led to depression — it was ruining his life.”

“His mom was willing to do whatever it took. And I said, You know what, I think filler will be enough,” Dr. Siperstein said. She counseled them that treatment would not make the scars disappear completely. But patients used to 10% improvements are very happy when their acne scars look 80% or 90% better, she added.

Dr. Siperstein received grant or research support and is a member of the speakers bureau for Allergan and Galderma. She is also a consultant/advisory board member for Allergan.
 

A version of this article appeared on Medscape.com.

Clinicians at Valley-Wide Health Systems never know who will appear at their clinic in San Luis, a town of about 600 people in southern Colorado.

“If someone’s in labor, they’ll show up. If someone has a laceration, they’ll show up,” said nurse practitioner Emelin Martinez, the chief medical officer for the healthcare system serving 13 rural Colorado counties.

But she struggled to find a full-time medical provider for that clinic, the only one in Costilla County. Born and raised in the area, Martinez filled some of the gap by driving about 45 minutes from Alamosa, the nearest city, once a week for months. A physician assistant from another town chipped in, too.

As one of the nation’s more than 1000 federally designated primary care shortage areas, Costilla County has many carrots to dangle in front of medical providers willing to practice there, including federal student loan repayments, bonus Medicare payments, and expedited visas for foreign clinicians. Still, Ms. Martinez said, its latest opening remained unfilled for more than a year. Not a single physician applied.

Policymakers have long tried to lure more primary care providers to the areas of the nation that have fewer than one physician for every 3500 residents. Recent examples include the Biden administration boosting funding in 2022 to address shortages and Sen. Bernie Sanders (I-Vt.) pushing sweeping primary care legislation in 2023.

But researchers steeped in the issue have a persistent frustration: It’s hard to know if any policy is working given that the data the federal government collects on primary care shortage areas has been flawed for a long time. One of the biggest gaps is that the system counts only physicians, not the myriad other healthcare professionals who now provide much of our nation›s primary care.

Additionally, a Health Affairs study shows the federal designations, which help allocate an estimated $1 billion in annual funding through at least 20 federal programs aimed at boosting primary care capacity, haven›t helped much.

In fact, Costilla County is among more than 180 federally designated areas that have remained stuck on the primary care shortage list for at least 40 years, according to a KFF Health News analysis. That›s even as the overall number of licensed US physicians more than doubled from 1990 to 2022 to over 1 million, according to the Federation of State Medical Boards, outpacing overall population growth.

No one disputes that much of the nation is starved for primary care clinicians, with patients having to wait weeks to get appointments or travel long distances for basic preventive care. Many doctors decide against primary care career paths, let alone practicing in isolated communities, because those jobs entail heavy workloads and earn less money and respect than specialists. But how does the nation solve the problem without knowing exactly where it is? And what tools must be used? Does a physician need to be the one providing the care?

Whitney Zahnd, president of the board of the Iowa Rural Health Association, said the fact that some rural areas have had such federal shortage designations for decades doesn’t prove they are ineffective. “Had the program not been there, would it have been even worse?” she said.

Federal funding supports 18,000 primary care doctors, nurse practitioners, and physician assistants to provide care to more than 18 million patients in the highest-need urban and rural communities across the country, said David Bowman, a spokesperson for the Health Resources and Services Administration, which manages the shortage designations. He said more than 80% of clinicians who get such scholarships or loan repayments continue to practice in shortage areas beyond their obligation of several years.

But that doesn’t mean they stick around forever.

Justin Markowski, a Yale School of Public Health doctoral student, coauthored the Health Affairs study that found the federal shortage designation makes no difference in upping physician density long-term. He is skeptical of policy ideas that promise big primary care fixes. That includes the Biden administration’s investment in more scholarships and loan repayments through the National Health Service Corps.

“You’re just throwing more money at a set of programs that don’t really seem to work,” he said. “We’ll see in a few years, but I’ll be shocked if it actually moved any physicians or any other advanced practice providers.”

One possible explanation for the persistence of shortage areas is that such incentives are too small or too fleeting.

But another issue is how shortages are measured. The government considers geographic shortage areas, now numbering just over 1000, but also population groups such as migrant farmworkers and individual facilities such as prisons that lack enough providers. Yet it’s up to state offices to identify populations and locations that might qualify as shortage areas and submit them to HRSA, which then scores the extent of any shortages. The funding and staffing for those state offices vary, creating an uneven foundation from which to map actual shortages.

“Some states became very adept at the equivalent of gerrymandering, where they were piecing together census blocks or census tracts in odd shapes in order to maximize the areas that are eligible,” said Stephen Petterson, a senior scholar at the Robert Graham Center, a policy think tank in Washington, DC, that focuses on primary care.

The federal Government Accountability Office has highlighted such issues since at least 1995, when it released a report identifying widespread data problems with the shortage area system and concluding it had “little assurance that federal funds are used where most needed.” The report noted one of the persistent shortcomings is that the system counts only physicians, not other key primary care providers.

Since 1998, federal officials have made three attempts to update the 1970s-era rules that define what counts as a shortage area. The authors of the Affordable Care Act tried most recently, tasking a committee of experts to decide on an update.

Among other things, the committee concluded in its 2011 report that nurse practitioners, physician assistants, and certified nurse midwives should be counted as primary care providers. But the recommendations fell short by just a handful of votes.

“We failed and the committee as a whole failed and HRSA failed by not moving the process forward,” said Petterson, who presented to the committee on how to comprehensively measure primary care needs.

Steve Holloway, who directs the Colorado health department’s Primary Care Office, served on the committee. Without action at the federal level, he then led a team to create Colorado’s own health professional shortage area designations that factor in nurse practitioners and physician assistants, not just doctors.

He said it’s taken about 6 years to create a tool and map of Colorado to answer a deceptively simple question: “How many actual flesh-and-blood, live clinicians are seeing patients?”

Ed Salsberg, who was the lead federal government representative on that committee and who headed HRSA’s National Center for Health Workforce Analysis, said the rest of the nation needs more precise data, too.

“It’s so important for the nation to target its resources to the highest-need communities,” he said. “It’s time again to try one more time to develop an improved methodology.”

In the past few years, more readily available data from insurance claims has allowed researchers to distinguish the medical providers who are practicing primary care from those who have specialized or retired.

Candice Chen, an associate professor of health policy and management at George Washington University’s Fitzhugh Mullan Institute for Health Workforce Equity, used claims data that reflects one large slice of the American population — about 66 million Medicaid beneficiaries — to map the primary care workforce.

Meanwhile, Monica O’Reilly-Jacob, a nurse-scientist who recently moved from Boston College to Columbia University’s School of Nursing, studied Medicare claims to conclude that fewer than 70% of physicians typically considered primary care providers were actually providing primary care. The rest, she said, often find more lucrative positions, such as subspecializing or working in hospitals. By contrast, nurse practitioners are likely undercounted. Her study found that close to half are providing primary care.

But such publicly available data leaves out much of the country, given that fewer than 40% of Americans are insured through Medicaid or Medicare.

“There’s no government organization that’s tracking: Who trained in what, where, and where are they now, and what are they practicing,” said Alison Huffstetler, medical director of the Robert Graham Center. “And if we don’t know who is doing what kind of care — and where — then there is no way for us to equitably manage the patient-to-clinician ratio across every state.”

In Costilla County, Ms. Martinez finally found someone to provide primary care: An experienced physician assistant who moved from Texas in December.

The physician assistant’s presence should bump the county out of its dire shortage, according to Colorado’s measure. But since he isn’t a physician, he’ll remain invisible in the national data and Costilla County will likely remain on the books as a federal shortage area.

Data reporter Hannah Recht, data editor Holly K. Hacker, and rural editor/correspondent Tony Leys contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — an independent source of health policy research, polling, and journalism.

Clinicians at Valley-Wide Health Systems never know who will appear at their clinic in San Luis, a town of about 600 people in southern Colorado.

“If someone’s in labor, they’ll show up. If someone has a laceration, they’ll show up,” said nurse practitioner Emelin Martinez, the chief medical officer for the healthcare system serving 13 rural Colorado counties.

But she struggled to find a full-time medical provider for that clinic, the only one in Costilla County. Born and raised in the area, Martinez filled some of the gap by driving about 45 minutes from Alamosa, the nearest city, once a week for months. A physician assistant from another town chipped in, too.

As one of the nation’s more than 1000 federally designated primary care shortage areas, Costilla County has many carrots to dangle in front of medical providers willing to practice there, including federal student loan repayments, bonus Medicare payments, and expedited visas for foreign clinicians. Still, Ms. Martinez said, its latest opening remained unfilled for more than a year. Not a single physician applied.

Policymakers have long tried to lure more primary care providers to the areas of the nation that have fewer than one physician for every 3500 residents. Recent examples include the Biden administration boosting funding in 2022 to address shortages and Sen. Bernie Sanders (I-Vt.) pushing sweeping primary care legislation in 2023.

But researchers steeped in the issue have a persistent frustration: It’s hard to know if any policy is working given that the data the federal government collects on primary care shortage areas has been flawed for a long time. One of the biggest gaps is that the system counts only physicians, not the myriad other healthcare professionals who now provide much of our nation›s primary care.

Additionally, a Health Affairs study shows the federal designations, which help allocate an estimated $1 billion in annual funding through at least 20 federal programs aimed at boosting primary care capacity, haven›t helped much.

In fact, Costilla County is among more than 180 federally designated areas that have remained stuck on the primary care shortage list for at least 40 years, according to a KFF Health News analysis. That›s even as the overall number of licensed US physicians more than doubled from 1990 to 2022 to over 1 million, according to the Federation of State Medical Boards, outpacing overall population growth.

No one disputes that much of the nation is starved for primary care clinicians, with patients having to wait weeks to get appointments or travel long distances for basic preventive care. Many doctors decide against primary care career paths, let alone practicing in isolated communities, because those jobs entail heavy workloads and earn less money and respect than specialists. But how does the nation solve the problem without knowing exactly where it is? And what tools must be used? Does a physician need to be the one providing the care?

Whitney Zahnd, president of the board of the Iowa Rural Health Association, said the fact that some rural areas have had such federal shortage designations for decades doesn’t prove they are ineffective. “Had the program not been there, would it have been even worse?” she said.

Federal funding supports 18,000 primary care doctors, nurse practitioners, and physician assistants to provide care to more than 18 million patients in the highest-need urban and rural communities across the country, said David Bowman, a spokesperson for the Health Resources and Services Administration, which manages the shortage designations. He said more than 80% of clinicians who get such scholarships or loan repayments continue to practice in shortage areas beyond their obligation of several years.

But that doesn’t mean they stick around forever.

Justin Markowski, a Yale School of Public Health doctoral student, coauthored the Health Affairs study that found the federal shortage designation makes no difference in upping physician density long-term. He is skeptical of policy ideas that promise big primary care fixes. That includes the Biden administration’s investment in more scholarships and loan repayments through the National Health Service Corps.

“You’re just throwing more money at a set of programs that don’t really seem to work,” he said. “We’ll see in a few years, but I’ll be shocked if it actually moved any physicians or any other advanced practice providers.”

One possible explanation for the persistence of shortage areas is that such incentives are too small or too fleeting.

But another issue is how shortages are measured. The government considers geographic shortage areas, now numbering just over 1000, but also population groups such as migrant farmworkers and individual facilities such as prisons that lack enough providers. Yet it’s up to state offices to identify populations and locations that might qualify as shortage areas and submit them to HRSA, which then scores the extent of any shortages. The funding and staffing for those state offices vary, creating an uneven foundation from which to map actual shortages.

“Some states became very adept at the equivalent of gerrymandering, where they were piecing together census blocks or census tracts in odd shapes in order to maximize the areas that are eligible,” said Stephen Petterson, a senior scholar at the Robert Graham Center, a policy think tank in Washington, DC, that focuses on primary care.

The federal Government Accountability Office has highlighted such issues since at least 1995, when it released a report identifying widespread data problems with the shortage area system and concluding it had “little assurance that federal funds are used where most needed.” The report noted one of the persistent shortcomings is that the system counts only physicians, not other key primary care providers.

Since 1998, federal officials have made three attempts to update the 1970s-era rules that define what counts as a shortage area. The authors of the Affordable Care Act tried most recently, tasking a committee of experts to decide on an update.

Among other things, the committee concluded in its 2011 report that nurse practitioners, physician assistants, and certified nurse midwives should be counted as primary care providers. But the recommendations fell short by just a handful of votes.

“We failed and the committee as a whole failed and HRSA failed by not moving the process forward,” said Petterson, who presented to the committee on how to comprehensively measure primary care needs.

Steve Holloway, who directs the Colorado health department’s Primary Care Office, served on the committee. Without action at the federal level, he then led a team to create Colorado’s own health professional shortage area designations that factor in nurse practitioners and physician assistants, not just doctors.

He said it’s taken about 6 years to create a tool and map of Colorado to answer a deceptively simple question: “How many actual flesh-and-blood, live clinicians are seeing patients?”

Ed Salsberg, who was the lead federal government representative on that committee and who headed HRSA’s National Center for Health Workforce Analysis, said the rest of the nation needs more precise data, too.

“It’s so important for the nation to target its resources to the highest-need communities,” he said. “It’s time again to try one more time to develop an improved methodology.”

In the past few years, more readily available data from insurance claims has allowed researchers to distinguish the medical providers who are practicing primary care from those who have specialized or retired.

Candice Chen, an associate professor of health policy and management at George Washington University’s Fitzhugh Mullan Institute for Health Workforce Equity, used claims data that reflects one large slice of the American population — about 66 million Medicaid beneficiaries — to map the primary care workforce.

Meanwhile, Monica O’Reilly-Jacob, a nurse-scientist who recently moved from Boston College to Columbia University’s School of Nursing, studied Medicare claims to conclude that fewer than 70% of physicians typically considered primary care providers were actually providing primary care. The rest, she said, often find more lucrative positions, such as subspecializing or working in hospitals. By contrast, nurse practitioners are likely undercounted. Her study found that close to half are providing primary care.

But such publicly available data leaves out much of the country, given that fewer than 40% of Americans are insured through Medicaid or Medicare.

“There’s no government organization that’s tracking: Who trained in what, where, and where are they now, and what are they practicing,” said Alison Huffstetler, medical director of the Robert Graham Center. “And if we don’t know who is doing what kind of care — and where — then there is no way for us to equitably manage the patient-to-clinician ratio across every state.”

In Costilla County, Ms. Martinez finally found someone to provide primary care: An experienced physician assistant who moved from Texas in December.

The physician assistant’s presence should bump the county out of its dire shortage, according to Colorado’s measure. But since he isn’t a physician, he’ll remain invisible in the national data and Costilla County will likely remain on the books as a federal shortage area.

Data reporter Hannah Recht, data editor Holly K. Hacker, and rural editor/correspondent Tony Leys contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — an independent source of health policy research, polling, and journalism.

Clinicians at Valley-Wide Health Systems never know who will appear at their clinic in San Luis, a town of about 600 people in southern Colorado.

“If someone’s in labor, they’ll show up. If someone has a laceration, they’ll show up,” said nurse practitioner Emelin Martinez, the chief medical officer for the healthcare system serving 13 rural Colorado counties.

But she struggled to find a full-time medical provider for that clinic, the only one in Costilla County. Born and raised in the area, Martinez filled some of the gap by driving about 45 minutes from Alamosa, the nearest city, once a week for months. A physician assistant from another town chipped in, too.

As one of the nation’s more than 1000 federally designated primary care shortage areas, Costilla County has many carrots to dangle in front of medical providers willing to practice there, including federal student loan repayments, bonus Medicare payments, and expedited visas for foreign clinicians. Still, Ms. Martinez said, its latest opening remained unfilled for more than a year. Not a single physician applied.

Policymakers have long tried to lure more primary care providers to the areas of the nation that have fewer than one physician for every 3500 residents. Recent examples include the Biden administration boosting funding in 2022 to address shortages and Sen. Bernie Sanders (I-Vt.) pushing sweeping primary care legislation in 2023.

But researchers steeped in the issue have a persistent frustration: It’s hard to know if any policy is working given that the data the federal government collects on primary care shortage areas has been flawed for a long time. One of the biggest gaps is that the system counts only physicians, not the myriad other healthcare professionals who now provide much of our nation›s primary care.

Additionally, a Health Affairs study shows the federal designations, which help allocate an estimated $1 billion in annual funding through at least 20 federal programs aimed at boosting primary care capacity, haven›t helped much.

In fact, Costilla County is among more than 180 federally designated areas that have remained stuck on the primary care shortage list for at least 40 years, according to a KFF Health News analysis. That›s even as the overall number of licensed US physicians more than doubled from 1990 to 2022 to over 1 million, according to the Federation of State Medical Boards, outpacing overall population growth.

No one disputes that much of the nation is starved for primary care clinicians, with patients having to wait weeks to get appointments or travel long distances for basic preventive care. Many doctors decide against primary care career paths, let alone practicing in isolated communities, because those jobs entail heavy workloads and earn less money and respect than specialists. But how does the nation solve the problem without knowing exactly where it is? And what tools must be used? Does a physician need to be the one providing the care?

Whitney Zahnd, president of the board of the Iowa Rural Health Association, said the fact that some rural areas have had such federal shortage designations for decades doesn’t prove they are ineffective. “Had the program not been there, would it have been even worse?” she said.

Federal funding supports 18,000 primary care doctors, nurse practitioners, and physician assistants to provide care to more than 18 million patients in the highest-need urban and rural communities across the country, said David Bowman, a spokesperson for the Health Resources and Services Administration, which manages the shortage designations. He said more than 80% of clinicians who get such scholarships or loan repayments continue to practice in shortage areas beyond their obligation of several years.

But that doesn’t mean they stick around forever.

Justin Markowski, a Yale School of Public Health doctoral student, coauthored the Health Affairs study that found the federal shortage designation makes no difference in upping physician density long-term. He is skeptical of policy ideas that promise big primary care fixes. That includes the Biden administration’s investment in more scholarships and loan repayments through the National Health Service Corps.

“You’re just throwing more money at a set of programs that don’t really seem to work,” he said. “We’ll see in a few years, but I’ll be shocked if it actually moved any physicians or any other advanced practice providers.”

One possible explanation for the persistence of shortage areas is that such incentives are too small or too fleeting.

But another issue is how shortages are measured. The government considers geographic shortage areas, now numbering just over 1000, but also population groups such as migrant farmworkers and individual facilities such as prisons that lack enough providers. Yet it’s up to state offices to identify populations and locations that might qualify as shortage areas and submit them to HRSA, which then scores the extent of any shortages. The funding and staffing for those state offices vary, creating an uneven foundation from which to map actual shortages.

“Some states became very adept at the equivalent of gerrymandering, where they were piecing together census blocks or census tracts in odd shapes in order to maximize the areas that are eligible,” said Stephen Petterson, a senior scholar at the Robert Graham Center, a policy think tank in Washington, DC, that focuses on primary care.

The federal Government Accountability Office has highlighted such issues since at least 1995, when it released a report identifying widespread data problems with the shortage area system and concluding it had “little assurance that federal funds are used where most needed.” The report noted one of the persistent shortcomings is that the system counts only physicians, not other key primary care providers.

Since 1998, federal officials have made three attempts to update the 1970s-era rules that define what counts as a shortage area. The authors of the Affordable Care Act tried most recently, tasking a committee of experts to decide on an update.

Among other things, the committee concluded in its 2011 report that nurse practitioners, physician assistants, and certified nurse midwives should be counted as primary care providers. But the recommendations fell short by just a handful of votes.

“We failed and the committee as a whole failed and HRSA failed by not moving the process forward,” said Petterson, who presented to the committee on how to comprehensively measure primary care needs.

Steve Holloway, who directs the Colorado health department’s Primary Care Office, served on the committee. Without action at the federal level, he then led a team to create Colorado’s own health professional shortage area designations that factor in nurse practitioners and physician assistants, not just doctors.

He said it’s taken about 6 years to create a tool and map of Colorado to answer a deceptively simple question: “How many actual flesh-and-blood, live clinicians are seeing patients?”

Ed Salsberg, who was the lead federal government representative on that committee and who headed HRSA’s National Center for Health Workforce Analysis, said the rest of the nation needs more precise data, too.

“It’s so important for the nation to target its resources to the highest-need communities,” he said. “It’s time again to try one more time to develop an improved methodology.”

In the past few years, more readily available data from insurance claims has allowed researchers to distinguish the medical providers who are practicing primary care from those who have specialized or retired.

Candice Chen, an associate professor of health policy and management at George Washington University’s Fitzhugh Mullan Institute for Health Workforce Equity, used claims data that reflects one large slice of the American population — about 66 million Medicaid beneficiaries — to map the primary care workforce.

Meanwhile, Monica O’Reilly-Jacob, a nurse-scientist who recently moved from Boston College to Columbia University’s School of Nursing, studied Medicare claims to conclude that fewer than 70% of physicians typically considered primary care providers were actually providing primary care. The rest, she said, often find more lucrative positions, such as subspecializing or working in hospitals. By contrast, nurse practitioners are likely undercounted. Her study found that close to half are providing primary care.

But such publicly available data leaves out much of the country, given that fewer than 40% of Americans are insured through Medicaid or Medicare.

“There’s no government organization that’s tracking: Who trained in what, where, and where are they now, and what are they practicing,” said Alison Huffstetler, medical director of the Robert Graham Center. “And if we don’t know who is doing what kind of care — and where — then there is no way for us to equitably manage the patient-to-clinician ratio across every state.”

In Costilla County, Ms. Martinez finally found someone to provide primary care: An experienced physician assistant who moved from Texas in December.

The physician assistant’s presence should bump the county out of its dire shortage, according to Colorado’s measure. But since he isn’t a physician, he’ll remain invisible in the national data and Costilla County will likely remain on the books as a federal shortage area.

Data reporter Hannah Recht, data editor Holly K. Hacker, and rural editor/correspondent Tony Leys contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — an independent source of health policy research, polling, and journalism.

Artificial intelligence (AI) has lagged in health care but has considerable potential to improve quality, safety, clinician experience, and access to care. It is being tested in areas like billing, hospital operations, and preventing adverse events (eg, sepsis mortality) with some early success. However, there are still many barriers preventing the widespread use of AI, such as data problems, mismatched rewards, and workplace obstacles. Innovative projects, partnerships, better rewards, and more investment could remove barriers. Implemented reliably and safely, AI can add to what clinicians know, help them work faster, cut costs, and, most importantly, improve patient care.¹

AI can potentially bring several clinical benefits, such as reducing the administrative strain on clinicians and granting them more time for direct patient care. It can also improve diagnostic accuracy by analyzing patient data and diagnostic images, providing differential diagnoses, and increasing access to care by providing medical information and essential online services to patients.²

High Reliability Organizations

High reliability health care organizations have considerable experience safely launching new programs. For example, the Patient Safety Adoption Framework gives practical tips for smoothly rolling out safety initiatives (Table 1). Developed with experts and diverse views, this framework has 5 key areas: leadership, culture and context, process, measurement, and person-centeredness. These address adoption problems, guide leaders step-by-step, and focus on leadership buy-in, safety culture, cooperation, and local customization. Checklists and tools make it systematic to go from ideas to action on patient safety.³

Leadership involves establishing organizational commitment behind new safety programs. This visible commitment signals importance and priorities to others. Leaders model desired behaviors and language around safety, allocate resources, remove obstacles, and keep initiatives energized over time through consistent messaging.⁴ Culture and context recognizes that safety culture differs across units and facilities. Local input tailors programs to fit and examines strengths to build on, like psychological safety. Surveys gauge the existing culture and its need for change. Process details how to plan, design, test, implement, and improve new safety practices and provides a phased roadmap from idea to results. Measurement collects data to drive improvement and show impact. Metrics track progress and allow benchmarking. Person-centeredness puts patients first in safety efforts through participation, education, and transparency.

The Veterans Health Administration piloted a comprehensive high reliability hospital (HRH) model. Over 3 years, the Veterans Health Administration focused on leadership, culture, and process improvement at a hospital. After initiating the model, the pilot hospital improved its safety culture, reported more minor safety issues, and reduced deaths and complications better than other hospitals. The high-reliability approach successfully instilled principles and improved culture and outcomes. The HRH model is set to be expanded to 18 more US Department of Veterans Affairs (VA) sites for further evaluation across diverse settings.⁵

Trustworthy AI Framework

AI systems are growing more powerful and widespread, including in health care. Unfortunately, irresponsible AI can introduce new harm. ChatGPT and other large language models, for example, sometimes are known to provide erroneous information in a compelling way. Clinicians and patients who use such programs can act on such information, which would lead to unforeseen negative consequences. Several frameworks on ethical AI have come from governmental groups.^6-9 In 2023, the VA National AI Institute suggested a Trustworthy AI Framework based on core principles tailored for federal health care. The framework has 6 key principles: purposeful, effective and safe, secure and private, fair and equitable, transparent and explainable, and accountable and monitored (Table 2).¹⁰

First, AI must clearly help veterans while minimizing risks. To ensure purpose, the VA will assess patient and clinician needs and design AI that targets meaningful problems to avoid scope creep or feature bloat. For example, adding new features to the AI software after release can clutter and complicate the interface, making it difficult to use. Rigorous testing will confirm that AI meets intent prior to deployment. Second, AI is designed and checked for effectiveness, safety, and reliability. The VA pledges to monitor AI’s impact to ensure it performs as expected without unintended consequences. Algorithms will be stress tested across representative datasets and approval processes will screen for safety issues. Third, AI models are secured from vulnerabilities and misuse. Technical controls will prevent unauthorized access or changes to AI systems. Audits will check for appropriate internal usage per policies. Continual patches and upgrades will maintain security. Fourth, the VA manages AI for fairness, avoiding bias. They will proactively assess datasets and algorithms for potential biases based on protected attributes like race, gender, or age. Biased outputs will be addressed through techniques such as data augmentation, reweighting, and algorithm tweaks. Fifth, transparency explains AI’s role in care. Documentation will detail an AI system’s data sources, methodology, testing, limitations, and integration with clinical workflows. Clinicians and patients will receive education on interpreting AI outputs. Finally, the VA pledges to closely monitor AI systems to sustain trust. The VA will establish oversight processes to quickly identify any declines in reliability or unfair impacts on subgroups. AI models will be retrained as needed based on incoming data patterns.

Each Trustworthy AI Framework principle connects to others in existing frameworks. The purpose principle aligns with human-centric AI focused on benefits. Effectiveness and safety link to technical robustness and risk management principles. Security maps to privacy protection principles. Fairness connects to principles of avoiding bias and discrimination. Transparency corresponds with accountable and explainable AI. Monitoring and accountability tie back to governance principles. Overall, the VA framework aims to guide ethical AI based on context. It offers a model for managing risks and building trust in health care AI.

Combining VA principles with high-reliability safety principles can ensure that AI benefits veterans. The leadership and culture aspects will drive commitment to trustworthy AI practices. Leaders will communicate the importance of responsible AI through words and actions. Culture surveys can assess baseline awareness of AI ethics issues to target education. AI security and fairness will be emphasized as safety critical. The process aspect will institute policies and procedures to uphold AI principles through the project lifecycle. For example, structured testing processes will validate safety. Measurement will collect data on principles like transparency and fairness. Dashboards can track metrics like explainability and biases. A patient-centered approach will incorporate veteran perspectives on AI through participatory design and advisory councils. They can give input on AI explainability and potential biases based on their diverse backgrounds.

Conclusions

Joint principles will lead to successful AI that improves care while proactively managing risks. Involve leaders to stress the necessity of eliminating biases. Build security into the AI development process. Co-design AI transparency features with end users. Closely monitor the impact of AI across safety, fairness, and other principles. Adhering to both Trustworthy AI and high reliability organizations principles will earn veterans’ confidence. Health care organizations like the VA can integrate ethical AI safely via established frameworks. With responsible design and implementation, AI’s potential to enhance care quality, safety, and access can be realized.

Acknowledgments

We would like to acknowledge Joshua Mueller, Theo Tiffney, John Zachary, and Gil Alterovitz for their excellent work creating the VA Trustworthy Principles. This material is the result of work supported by resources and the use of facilities at the James A. Haley Veterans’ Hospital.

Artificial intelligence (AI) has lagged in health care but has considerable potential to improve quality, safety, clinician experience, and access to care. It is being tested in areas like billing, hospital operations, and preventing adverse events (eg, sepsis mortality) with some early success. However, there are still many barriers preventing the widespread use of AI, such as data problems, mismatched rewards, and workplace obstacles. Innovative projects, partnerships, better rewards, and more investment could remove barriers. Implemented reliably and safely, AI can add to what clinicians know, help them work faster, cut costs, and, most importantly, improve patient care.¹

AI can potentially bring several clinical benefits, such as reducing the administrative strain on clinicians and granting them more time for direct patient care. It can also improve diagnostic accuracy by analyzing patient data and diagnostic images, providing differential diagnoses, and increasing access to care by providing medical information and essential online services to patients.²

High Reliability Organizations

High reliability health care organizations have considerable experience safely launching new programs. For example, the Patient Safety Adoption Framework gives practical tips for smoothly rolling out safety initiatives (Table 1). Developed with experts and diverse views, this framework has 5 key areas: leadership, culture and context, process, measurement, and person-centeredness. These address adoption problems, guide leaders step-by-step, and focus on leadership buy-in, safety culture, cooperation, and local customization. Checklists and tools make it systematic to go from ideas to action on patient safety.³

Leadership involves establishing organizational commitment behind new safety programs. This visible commitment signals importance and priorities to others. Leaders model desired behaviors and language around safety, allocate resources, remove obstacles, and keep initiatives energized over time through consistent messaging.⁴ Culture and context recognizes that safety culture differs across units and facilities. Local input tailors programs to fit and examines strengths to build on, like psychological safety. Surveys gauge the existing culture and its need for change. Process details how to plan, design, test, implement, and improve new safety practices and provides a phased roadmap from idea to results. Measurement collects data to drive improvement and show impact. Metrics track progress and allow benchmarking. Person-centeredness puts patients first in safety efforts through participation, education, and transparency.

The Veterans Health Administration piloted a comprehensive high reliability hospital (HRH) model. Over 3 years, the Veterans Health Administration focused on leadership, culture, and process improvement at a hospital. After initiating the model, the pilot hospital improved its safety culture, reported more minor safety issues, and reduced deaths and complications better than other hospitals. The high-reliability approach successfully instilled principles and improved culture and outcomes. The HRH model is set to be expanded to 18 more US Department of Veterans Affairs (VA) sites for further evaluation across diverse settings.⁵

Trustworthy AI Framework

AI systems are growing more powerful and widespread, including in health care. Unfortunately, irresponsible AI can introduce new harm. ChatGPT and other large language models, for example, sometimes are known to provide erroneous information in a compelling way. Clinicians and patients who use such programs can act on such information, which would lead to unforeseen negative consequences. Several frameworks on ethical AI have come from governmental groups.^6-9 In 2023, the VA National AI Institute suggested a Trustworthy AI Framework based on core principles tailored for federal health care. The framework has 6 key principles: purposeful, effective and safe, secure and private, fair and equitable, transparent and explainable, and accountable and monitored (Table 2).¹⁰

First, AI must clearly help veterans while minimizing risks. To ensure purpose, the VA will assess patient and clinician needs and design AI that targets meaningful problems to avoid scope creep or feature bloat. For example, adding new features to the AI software after release can clutter and complicate the interface, making it difficult to use. Rigorous testing will confirm that AI meets intent prior to deployment. Second, AI is designed and checked for effectiveness, safety, and reliability. The VA pledges to monitor AI’s impact to ensure it performs as expected without unintended consequences. Algorithms will be stress tested across representative datasets and approval processes will screen for safety issues. Third, AI models are secured from vulnerabilities and misuse. Technical controls will prevent unauthorized access or changes to AI systems. Audits will check for appropriate internal usage per policies. Continual patches and upgrades will maintain security. Fourth, the VA manages AI for fairness, avoiding bias. They will proactively assess datasets and algorithms for potential biases based on protected attributes like race, gender, or age. Biased outputs will be addressed through techniques such as data augmentation, reweighting, and algorithm tweaks. Fifth, transparency explains AI’s role in care. Documentation will detail an AI system’s data sources, methodology, testing, limitations, and integration with clinical workflows. Clinicians and patients will receive education on interpreting AI outputs. Finally, the VA pledges to closely monitor AI systems to sustain trust. The VA will establish oversight processes to quickly identify any declines in reliability or unfair impacts on subgroups. AI models will be retrained as needed based on incoming data patterns.

Each Trustworthy AI Framework principle connects to others in existing frameworks. The purpose principle aligns with human-centric AI focused on benefits. Effectiveness and safety link to technical robustness and risk management principles. Security maps to privacy protection principles. Fairness connects to principles of avoiding bias and discrimination. Transparency corresponds with accountable and explainable AI. Monitoring and accountability tie back to governance principles. Overall, the VA framework aims to guide ethical AI based on context. It offers a model for managing risks and building trust in health care AI.

Combining VA principles with high-reliability safety principles can ensure that AI benefits veterans. The leadership and culture aspects will drive commitment to trustworthy AI practices. Leaders will communicate the importance of responsible AI through words and actions. Culture surveys can assess baseline awareness of AI ethics issues to target education. AI security and fairness will be emphasized as safety critical. The process aspect will institute policies and procedures to uphold AI principles through the project lifecycle. For example, structured testing processes will validate safety. Measurement will collect data on principles like transparency and fairness. Dashboards can track metrics like explainability and biases. A patient-centered approach will incorporate veteran perspectives on AI through participatory design and advisory councils. They can give input on AI explainability and potential biases based on their diverse backgrounds.

Conclusions

Joint principles will lead to successful AI that improves care while proactively managing risks. Involve leaders to stress the necessity of eliminating biases. Build security into the AI development process. Co-design AI transparency features with end users. Closely monitor the impact of AI across safety, fairness, and other principles. Adhering to both Trustworthy AI and high reliability organizations principles will earn veterans’ confidence. Health care organizations like the VA can integrate ethical AI safely via established frameworks. With responsible design and implementation, AI’s potential to enhance care quality, safety, and access can be realized.

Acknowledgments

We would like to acknowledge Joshua Mueller, Theo Tiffney, John Zachary, and Gil Alterovitz for their excellent work creating the VA Trustworthy Principles. This material is the result of work supported by resources and the use of facilities at the James A. Haley Veterans’ Hospital.

Artificial intelligence (AI) has lagged in health care but has considerable potential to improve quality, safety, clinician experience, and access to care. It is being tested in areas like billing, hospital operations, and preventing adverse events (eg, sepsis mortality) with some early success. However, there are still many barriers preventing the widespread use of AI, such as data problems, mismatched rewards, and workplace obstacles. Innovative projects, partnerships, better rewards, and more investment could remove barriers. Implemented reliably and safely, AI can add to what clinicians know, help them work faster, cut costs, and, most importantly, improve patient care.¹

AI can potentially bring several clinical benefits, such as reducing the administrative strain on clinicians and granting them more time for direct patient care. It can also improve diagnostic accuracy by analyzing patient data and diagnostic images, providing differential diagnoses, and increasing access to care by providing medical information and essential online services to patients.²

High Reliability Organizations

High reliability health care organizations have considerable experience safely launching new programs. For example, the Patient Safety Adoption Framework gives practical tips for smoothly rolling out safety initiatives (Table 1). Developed with experts and diverse views, this framework has 5 key areas: leadership, culture and context, process, measurement, and person-centeredness. These address adoption problems, guide leaders step-by-step, and focus on leadership buy-in, safety culture, cooperation, and local customization. Checklists and tools make it systematic to go from ideas to action on patient safety.³

Leadership involves establishing organizational commitment behind new safety programs. This visible commitment signals importance and priorities to others. Leaders model desired behaviors and language around safety, allocate resources, remove obstacles, and keep initiatives energized over time through consistent messaging.⁴ Culture and context recognizes that safety culture differs across units and facilities. Local input tailors programs to fit and examines strengths to build on, like psychological safety. Surveys gauge the existing culture and its need for change. Process details how to plan, design, test, implement, and improve new safety practices and provides a phased roadmap from idea to results. Measurement collects data to drive improvement and show impact. Metrics track progress and allow benchmarking. Person-centeredness puts patients first in safety efforts through participation, education, and transparency.

The Veterans Health Administration piloted a comprehensive high reliability hospital (HRH) model. Over 3 years, the Veterans Health Administration focused on leadership, culture, and process improvement at a hospital. After initiating the model, the pilot hospital improved its safety culture, reported more minor safety issues, and reduced deaths and complications better than other hospitals. The high-reliability approach successfully instilled principles and improved culture and outcomes. The HRH model is set to be expanded to 18 more US Department of Veterans Affairs (VA) sites for further evaluation across diverse settings.⁵

Trustworthy AI Framework

AI systems are growing more powerful and widespread, including in health care. Unfortunately, irresponsible AI can introduce new harm. ChatGPT and other large language models, for example, sometimes are known to provide erroneous information in a compelling way. Clinicians and patients who use such programs can act on such information, which would lead to unforeseen negative consequences. Several frameworks on ethical AI have come from governmental groups.^6-9 In 2023, the VA National AI Institute suggested a Trustworthy AI Framework based on core principles tailored for federal health care. The framework has 6 key principles: purposeful, effective and safe, secure and private, fair and equitable, transparent and explainable, and accountable and monitored (Table 2).¹⁰

First, AI must clearly help veterans while minimizing risks. To ensure purpose, the VA will assess patient and clinician needs and design AI that targets meaningful problems to avoid scope creep or feature bloat. For example, adding new features to the AI software after release can clutter and complicate the interface, making it difficult to use. Rigorous testing will confirm that AI meets intent prior to deployment. Second, AI is designed and checked for effectiveness, safety, and reliability. The VA pledges to monitor AI’s impact to ensure it performs as expected without unintended consequences. Algorithms will be stress tested across representative datasets and approval processes will screen for safety issues. Third, AI models are secured from vulnerabilities and misuse. Technical controls will prevent unauthorized access or changes to AI systems. Audits will check for appropriate internal usage per policies. Continual patches and upgrades will maintain security. Fourth, the VA manages AI for fairness, avoiding bias. They will proactively assess datasets and algorithms for potential biases based on protected attributes like race, gender, or age. Biased outputs will be addressed through techniques such as data augmentation, reweighting, and algorithm tweaks. Fifth, transparency explains AI’s role in care. Documentation will detail an AI system’s data sources, methodology, testing, limitations, and integration with clinical workflows. Clinicians and patients will receive education on interpreting AI outputs. Finally, the VA pledges to closely monitor AI systems to sustain trust. The VA will establish oversight processes to quickly identify any declines in reliability or unfair impacts on subgroups. AI models will be retrained as needed based on incoming data patterns.

Each Trustworthy AI Framework principle connects to others in existing frameworks. The purpose principle aligns with human-centric AI focused on benefits. Effectiveness and safety link to technical robustness and risk management principles. Security maps to privacy protection principles. Fairness connects to principles of avoiding bias and discrimination. Transparency corresponds with accountable and explainable AI. Monitoring and accountability tie back to governance principles. Overall, the VA framework aims to guide ethical AI based on context. It offers a model for managing risks and building trust in health care AI.

Combining VA principles with high-reliability safety principles can ensure that AI benefits veterans. The leadership and culture aspects will drive commitment to trustworthy AI practices. Leaders will communicate the importance of responsible AI through words and actions. Culture surveys can assess baseline awareness of AI ethics issues to target education. AI security and fairness will be emphasized as safety critical. The process aspect will institute policies and procedures to uphold AI principles through the project lifecycle. For example, structured testing processes will validate safety. Measurement will collect data on principles like transparency and fairness. Dashboards can track metrics like explainability and biases. A patient-centered approach will incorporate veteran perspectives on AI through participatory design and advisory councils. They can give input on AI explainability and potential biases based on their diverse backgrounds.

Conclusions

Joint principles will lead to successful AI that improves care while proactively managing risks. Involve leaders to stress the necessity of eliminating biases. Build security into the AI development process. Co-design AI transparency features with end users. Closely monitor the impact of AI across safety, fairness, and other principles. Adhering to both Trustworthy AI and high reliability organizations principles will earn veterans’ confidence. Health care organizations like the VA can integrate ethical AI safely via established frameworks. With responsible design and implementation, AI’s potential to enhance care quality, safety, and access can be realized.

Acknowledgments

We would like to acknowledge Joshua Mueller, Theo Tiffney, John Zachary, and Gil Alterovitz for their excellent work creating the VA Trustworthy Principles. This material is the result of work supported by resources and the use of facilities at the James A. Haley Veterans’ Hospital.

Most Americans’ views about obesity and bariatric surgery are colored by stigmas, according to a new survey from the healthcare system at Orlando Health.

For example, most Americans believe that weight loss surgery should be pursued only as a last resort and that bariatric surgery is a shortcut to shedding pounds, the survey found.

Common stigmas could be deterring people who qualify for bariatric surgery from pursuing it, according to Orlando Health, located in Florida.

“Bariatric surgery is by no means an easy way out. If you have the courage to ask for help and commit to doing the hard work of changing your diet and improving your life, you’re a champion in my book,” said Andre Teixeira, MD, medical director and bariatric surgeon at Orlando Health Weight Loss and Bariatric Surgery Institute, Orlando, Florida.

“Surgery is simply a tool to jumpstart that change,” he said. “After surgery, it is up to the patient to learn how to eat well, implement exercise into their routine, and shift their mindset to maintain their health for the rest of their lives.”

The survey results were published in January by Orlando Health.
 

Surveying Americans

The national survey, conducted for Orlando Health by the market research firm Ipsos in early November 2023, asked 1017 US adults whether they agreed or disagreed with several statements about weight loss and bariatric surgery. The statements and responses are as follows:

• “Weight loss surgery is a shortcut to shedding pounds” — 60% strongly or somewhat agreed, 38% strongly or somewhat disagreed, and the remainder declined to answer.
• “Weight loss surgery is cosmetic and mainly impacts appearance” — 37% strongly or somewhat agreed, 61% strongly or somewhat disagreed, and the remainder declined to respond.
• “Exercise and diet should be enough for weight loss” — 61% strongly or somewhat agreed, 37% strongly or somewhat disagreed, and the remainder declined to respond.
• “Weight loss surgery should only be pursued as a last resort” — 79% strongly or somewhat agreed, 19% strongly or somewhat disagreed, and the remainder declined to answer.
• “Surgery should be more socially accepted as a way to lose weight” — 46% strongly or somewhat agreed, 52% strongly or somewhat disagreed, and the remainder declined to respond.

Men’s responses indicated that they are more likely to have negative views toward weight loss surgery than women. For example, 66% of men vs 54% of women respondents see weight loss surgery as a shortcut to losing weight. Conversely, 42% of men vs 50% of women said that surgery should be a more socially accepted weight loss method.

Opinions that might interfere with the willingness to have weight loss surgery were apparent among people with obesity. The survey found that 65% of respondents with obesity and 59% with extreme obesity view surgery as a shortcut. Eighty-two percent of respondents with obesity and 68% with extreme obesity see surgery as a last resort.

At the end of 2022, the American Society of Metabolic and Bariatric Surgery and the International Federation for the Surgery of Obesity and Metabolic Disorders updated their guidelines for metabolic and bariatric surgery for the first time since 1991, with the aim of expanding access to surgery, Orlando Health noted. However, only 1% of those who are clinically eligible end up undergoing weight loss surgery, even with advancements in laparoscopic and robotic techniques that have made it safer and less invasive, the health system added.

“Because of the stigma around obesity and bariatric surgery, so many of my patients feel defeated if they can’t lose weight on their own,” said Muhammad Ghanem, MD, a bariatric surgeon at Orlando Health.

“But when I tell them obesity is a disease and that many of its causes are outside of their control, you can see their relief,” he said. “They often even shed a tear because they’ve struggled with their weight all their lives and finally have some validation.”
 

Individualizing Treatment

Obesity treatment plans should be tailored to patients on the basis of individual factors such as body mass index, existing medical conditions, and family history, Dr. Teixeira said.

Besides bariatric surgery, patients also may consider options such as counseling, lifestyle changes, and medications including the latest weight loss drugs, he added.

The clinical approach to obesity treatment has evolved, said Miguel Burch, MD, director of general surgery and chief of minimally invasive and gastrointestinal surgery at Cedars-Sinai, Los Angeles, California, who was not involved in the survey.

“At one point in my career, I could say the only proven durable treatment for obesity is weight loss surgery. This was in the context of patients who were morbidly obese requiring risk reduction, not for a year or two but for decades, and not for 10-20 pounds but for 40-60 pounds of weight loss,” said Dr. Burch, who also directs the bariatric surgery program at Torrance Memorial Medical Center, Torrance, California.

“That was a previous era. We are now in a new one with the weight loss drugs,” Dr. Burch said. “In fact, it’s wonderful to have the opportunity to serve so many patients with an option other than just surgery.”

Still, Dr. Burch added, “we have to change the way we look at obesity management as being either surgery or medicine and start thinking about it more as a multidisciplinary approach to a chronic and potentially relapsing disease.”

A version of this article appeared on Medscape.com.

Most Americans’ views about obesity and bariatric surgery are colored by stigmas, according to a new survey from the healthcare system at Orlando Health.

For example, most Americans believe that weight loss surgery should be pursued only as a last resort and that bariatric surgery is a shortcut to shedding pounds, the survey found.

Common stigmas could be deterring people who qualify for bariatric surgery from pursuing it, according to Orlando Health, located in Florida.

“Bariatric surgery is by no means an easy way out. If you have the courage to ask for help and commit to doing the hard work of changing your diet and improving your life, you’re a champion in my book,” said Andre Teixeira, MD, medical director and bariatric surgeon at Orlando Health Weight Loss and Bariatric Surgery Institute, Orlando, Florida.

“Surgery is simply a tool to jumpstart that change,” he said. “After surgery, it is up to the patient to learn how to eat well, implement exercise into their routine, and shift their mindset to maintain their health for the rest of their lives.”

The survey results were published in January by Orlando Health.
 

Surveying Americans

The national survey, conducted for Orlando Health by the market research firm Ipsos in early November 2023, asked 1017 US adults whether they agreed or disagreed with several statements about weight loss and bariatric surgery. The statements and responses are as follows:

• “Weight loss surgery is a shortcut to shedding pounds” — 60% strongly or somewhat agreed, 38% strongly or somewhat disagreed, and the remainder declined to answer.
• “Weight loss surgery is cosmetic and mainly impacts appearance” — 37% strongly or somewhat agreed, 61% strongly or somewhat disagreed, and the remainder declined to respond.
• “Exercise and diet should be enough for weight loss” — 61% strongly or somewhat agreed, 37% strongly or somewhat disagreed, and the remainder declined to respond.
• “Weight loss surgery should only be pursued as a last resort” — 79% strongly or somewhat agreed, 19% strongly or somewhat disagreed, and the remainder declined to answer.
• “Surgery should be more socially accepted as a way to lose weight” — 46% strongly or somewhat agreed, 52% strongly or somewhat disagreed, and the remainder declined to respond.

Men’s responses indicated that they are more likely to have negative views toward weight loss surgery than women. For example, 66% of men vs 54% of women respondents see weight loss surgery as a shortcut to losing weight. Conversely, 42% of men vs 50% of women said that surgery should be a more socially accepted weight loss method.

Opinions that might interfere with the willingness to have weight loss surgery were apparent among people with obesity. The survey found that 65% of respondents with obesity and 59% with extreme obesity view surgery as a shortcut. Eighty-two percent of respondents with obesity and 68% with extreme obesity see surgery as a last resort.

At the end of 2022, the American Society of Metabolic and Bariatric Surgery and the International Federation for the Surgery of Obesity and Metabolic Disorders updated their guidelines for metabolic and bariatric surgery for the first time since 1991, with the aim of expanding access to surgery, Orlando Health noted. However, only 1% of those who are clinically eligible end up undergoing weight loss surgery, even with advancements in laparoscopic and robotic techniques that have made it safer and less invasive, the health system added.

“Because of the stigma around obesity and bariatric surgery, so many of my patients feel defeated if they can’t lose weight on their own,” said Muhammad Ghanem, MD, a bariatric surgeon at Orlando Health.

“But when I tell them obesity is a disease and that many of its causes are outside of their control, you can see their relief,” he said. “They often even shed a tear because they’ve struggled with their weight all their lives and finally have some validation.”
 

Individualizing Treatment

Obesity treatment plans should be tailored to patients on the basis of individual factors such as body mass index, existing medical conditions, and family history, Dr. Teixeira said.

Besides bariatric surgery, patients also may consider options such as counseling, lifestyle changes, and medications including the latest weight loss drugs, he added.

The clinical approach to obesity treatment has evolved, said Miguel Burch, MD, director of general surgery and chief of minimally invasive and gastrointestinal surgery at Cedars-Sinai, Los Angeles, California, who was not involved in the survey.

“At one point in my career, I could say the only proven durable treatment for obesity is weight loss surgery. This was in the context of patients who were morbidly obese requiring risk reduction, not for a year or two but for decades, and not for 10-20 pounds but for 40-60 pounds of weight loss,” said Dr. Burch, who also directs the bariatric surgery program at Torrance Memorial Medical Center, Torrance, California.

“That was a previous era. We are now in a new one with the weight loss drugs,” Dr. Burch said. “In fact, it’s wonderful to have the opportunity to serve so many patients with an option other than just surgery.”

Still, Dr. Burch added, “we have to change the way we look at obesity management as being either surgery or medicine and start thinking about it more as a multidisciplinary approach to a chronic and potentially relapsing disease.”

A version of this article appeared on Medscape.com.

Most Americans’ views about obesity and bariatric surgery are colored by stigmas, according to a new survey from the healthcare system at Orlando Health.

For example, most Americans believe that weight loss surgery should be pursued only as a last resort and that bariatric surgery is a shortcut to shedding pounds, the survey found.

Common stigmas could be deterring people who qualify for bariatric surgery from pursuing it, according to Orlando Health, located in Florida.

“Bariatric surgery is by no means an easy way out. If you have the courage to ask for help and commit to doing the hard work of changing your diet and improving your life, you’re a champion in my book,” said Andre Teixeira, MD, medical director and bariatric surgeon at Orlando Health Weight Loss and Bariatric Surgery Institute, Orlando, Florida.

“Surgery is simply a tool to jumpstart that change,” he said. “After surgery, it is up to the patient to learn how to eat well, implement exercise into their routine, and shift their mindset to maintain their health for the rest of their lives.”

The survey results were published in January by Orlando Health.
 

Surveying Americans

The national survey, conducted for Orlando Health by the market research firm Ipsos in early November 2023, asked 1017 US adults whether they agreed or disagreed with several statements about weight loss and bariatric surgery. The statements and responses are as follows:

• “Weight loss surgery is a shortcut to shedding pounds” — 60% strongly or somewhat agreed, 38% strongly or somewhat disagreed, and the remainder declined to answer.
• “Weight loss surgery is cosmetic and mainly impacts appearance” — 37% strongly or somewhat agreed, 61% strongly or somewhat disagreed, and the remainder declined to respond.
• “Exercise and diet should be enough for weight loss” — 61% strongly or somewhat agreed, 37% strongly or somewhat disagreed, and the remainder declined to respond.
• “Weight loss surgery should only be pursued as a last resort” — 79% strongly or somewhat agreed, 19% strongly or somewhat disagreed, and the remainder declined to answer.
• “Surgery should be more socially accepted as a way to lose weight” — 46% strongly or somewhat agreed, 52% strongly or somewhat disagreed, and the remainder declined to respond.

Men’s responses indicated that they are more likely to have negative views toward weight loss surgery than women. For example, 66% of men vs 54% of women respondents see weight loss surgery as a shortcut to losing weight. Conversely, 42% of men vs 50% of women said that surgery should be a more socially accepted weight loss method.

Opinions that might interfere with the willingness to have weight loss surgery were apparent among people with obesity. The survey found that 65% of respondents with obesity and 59% with extreme obesity view surgery as a shortcut. Eighty-two percent of respondents with obesity and 68% with extreme obesity see surgery as a last resort.

At the end of 2022, the American Society of Metabolic and Bariatric Surgery and the International Federation for the Surgery of Obesity and Metabolic Disorders updated their guidelines for metabolic and bariatric surgery for the first time since 1991, with the aim of expanding access to surgery, Orlando Health noted. However, only 1% of those who are clinically eligible end up undergoing weight loss surgery, even with advancements in laparoscopic and robotic techniques that have made it safer and less invasive, the health system added.

“Because of the stigma around obesity and bariatric surgery, so many of my patients feel defeated if they can’t lose weight on their own,” said Muhammad Ghanem, MD, a bariatric surgeon at Orlando Health.

“But when I tell them obesity is a disease and that many of its causes are outside of their control, you can see their relief,” he said. “They often even shed a tear because they’ve struggled with their weight all their lives and finally have some validation.”
 

Individualizing Treatment

Obesity treatment plans should be tailored to patients on the basis of individual factors such as body mass index, existing medical conditions, and family history, Dr. Teixeira said.

Besides bariatric surgery, patients also may consider options such as counseling, lifestyle changes, and medications including the latest weight loss drugs, he added.

The clinical approach to obesity treatment has evolved, said Miguel Burch, MD, director of general surgery and chief of minimally invasive and gastrointestinal surgery at Cedars-Sinai, Los Angeles, California, who was not involved in the survey.

“At one point in my career, I could say the only proven durable treatment for obesity is weight loss surgery. This was in the context of patients who were morbidly obese requiring risk reduction, not for a year or two but for decades, and not for 10-20 pounds but for 40-60 pounds of weight loss,” said Dr. Burch, who also directs the bariatric surgery program at Torrance Memorial Medical Center, Torrance, California.

“That was a previous era. We are now in a new one with the weight loss drugs,” Dr. Burch said. “In fact, it’s wonderful to have the opportunity to serve so many patients with an option other than just surgery.”

Still, Dr. Burch added, “we have to change the way we look at obesity management as being either surgery or medicine and start thinking about it more as a multidisciplinary approach to a chronic and potentially relapsing disease.”

A version of this article appeared on Medscape.com.

Dear Friends,

After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.

Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.

In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.

As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.

Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.
 

Yours truly,

Judy A. Trieu, MD, MPH

Editor-in-Chief

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

Dear Friends,

After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.

Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.

In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.

As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.

Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.
 

Yours truly,

Judy A. Trieu, MD, MPH

Editor-in-Chief

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

Dear Friends,

After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.

Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.

In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.

As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.

Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.
 

Yours truly,

Judy A. Trieu, MD, MPH

Editor-in-Chief

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

As an organization, AGA has invested heavily in programs and initiatives to support the professional development of its members across career stages. This includes programs such as the AGA-AASLD Academic Skills Workshop (in which I was fortunate to participate in 2016), Women’s Leadership and Executive Leadership Conferences (with the Midwest Women in GI Regional Workshop taking place later this month), and the AGA Research Foundation Awards Program, which distributes over $2 million in funding annually to support promising early career and senior investigators.

AGA’s Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) Program, which was first funded by the National Institutes of Health in 2018 and is focused on improving the diversity of the GI research workforce, is another shining example. Led by Dr. Byron Cryer and Dr. Sandra Quezada, the program recently welcomed its 3rd cohort of participants, including 14 mentees and 28 senior and near-peer mentors.

As a longstanding AGA member, I am proud to be a part of an organization that values diversity and invests in cutting-edge programs to support development of future leaders in our field across multiple domains. We are pleased to frequently highlight these programs in the pages of GI & Hepatology News, and hope you enjoy learning more about each of these initiatives in future issues.

University of Michigan

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

As an organization, AGA has invested heavily in programs and initiatives to support the professional development of its members across career stages. This includes programs such as the AGA-AASLD Academic Skills Workshop (in which I was fortunate to participate in 2016), Women’s Leadership and Executive Leadership Conferences (with the Midwest Women in GI Regional Workshop taking place later this month), and the AGA Research Foundation Awards Program, which distributes over $2 million in funding annually to support promising early career and senior investigators.

AGA’s Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) Program, which was first funded by the National Institutes of Health in 2018 and is focused on improving the diversity of the GI research workforce, is another shining example. Led by Dr. Byron Cryer and Dr. Sandra Quezada, the program recently welcomed its 3rd cohort of participants, including 14 mentees and 28 senior and near-peer mentors.

As a longstanding AGA member, I am proud to be a part of an organization that values diversity and invests in cutting-edge programs to support development of future leaders in our field across multiple domains. We are pleased to frequently highlight these programs in the pages of GI & Hepatology News, and hope you enjoy learning more about each of these initiatives in future issues.

University of Michigan

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

As an organization, AGA has invested heavily in programs and initiatives to support the professional development of its members across career stages. This includes programs such as the AGA-AASLD Academic Skills Workshop (in which I was fortunate to participate in 2016), Women’s Leadership and Executive Leadership Conferences (with the Midwest Women in GI Regional Workshop taking place later this month), and the AGA Research Foundation Awards Program, which distributes over $2 million in funding annually to support promising early career and senior investigators.

AGA’s Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) Program, which was first funded by the National Institutes of Health in 2018 and is focused on improving the diversity of the GI research workforce, is another shining example. Led by Dr. Byron Cryer and Dr. Sandra Quezada, the program recently welcomed its 3rd cohort of participants, including 14 mentees and 28 senior and near-peer mentors.

As a longstanding AGA member, I am proud to be a part of an organization that values diversity and invests in cutting-edge programs to support development of future leaders in our field across multiple domains. We are pleased to frequently highlight these programs in the pages of GI & Hepatology News, and hope you enjoy learning more about each of these initiatives in future issues.

University of Michigan

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

To the Editor:

A 14-year-old Black adolescent girl presented with episodic, painful, edematous plaques that occurred symmetrically on the arms and legs of 5 years’ duration. The plaques evolved into hyperpigmented patches within 24 to 48 hours before eventually resolving. Fatigue, headache, arthralgias of the arms and legs, chest pain, abdominal pain, nausea, and vomiting variably accompanied these episodes.

Prior to visiting our clinic, the patient had been seen by numerous specialists. A review of her medical records revealed an initial diagnosis of Henoch-Schönlein purpura (HSP), then urticarial vasculitis. She had been treated with antihistamines, topical and systemic steroids, hydroxychloroquine, mycophenolate mofetil, dapsone, azathioprine, and gabapentin. All treatments were ineffectual. She underwent extensive diagnostic testing and imaging, which were normal or noncontributory, including type I allergy testing; multiple exhaustive batteries of hematologic testing; and computed tomography/magnetic resonance imaging/magnetic resonance angiography of the brain, chest, abdomen, and pelvic region. Biopsies from symptomatic segments of the gastrointestinal tract were normal.

Chronic treatment with systemic steroids over 9 months resulted in gastritis and an episode of hematemesis requiring emergent hospitalization. A lengthy multidisciplinary evaluation was conducted at the patient’s local community hospital; the team concluded that she had an urticarial-type rash with accompanying symptoms that did not have an autoimmune, rheumatologic, or inflammatory basis.

The patient’s medical history was remarkable for recent-onset panic attacks. Her family medical history was noncontributory. Physical examination revealed multiple violaceous hyperpigmented patches diffusely located on the proximal upper arms (Figure 1). There were no additional findings on physical examination.

Punch biopsies were performed on lesional areas of the arm. Histopathology indicated a mild superficial perivascular dermal mixed infiltrate and extravasated erythrocytes (Figure 2). Direct immunofluorescence (DIF) testing was negative for vasculitis. Immunohistochemical stains for CD117 and tryptase demonstrated a slight increase in the number of dermal mast cells; however, the increase was not sufficient to diagnose cutaneous mastocytosis, which was in the differential. We proposed a diagnosis of psychogenic purpura (PP)(also known as Gardner-Diamond syndrome). She was treated with gabapentin, a selective serotonin reuptake inhibitor, and cognitive therapy. Unfortunately, after starting therapy the patient was lost to follow-up.

Psychogenic purpura is a rare vasculopathy of unknown etiology that may be a special form of factitious disorder.^1,2 In one study, PP occurred predominantly in females aged 15 to 66 years, with a median onset age of 33 years.³ A prodrome of localized itching, burning, and/or pain precedes the development of edematous plaques. The plaques evolve into painful ecchymoses within 1 to 2 days and resolve in 10 days or fewer without treatment. Lesions most commonly occur on the extremities but may occur anywhere on the body. The most common associated finding is an underlying depressive disorder. Episodes may be accompanied by headache, dizziness, fatigue, fever, arthralgia, nausea, vomiting, abdominal pain, menstrual irregularities, myalgia, and urologic conditions.

In 1955, Gardner and Diamond⁴ described the first cases of PP in 4 female patients at Peter Bent Brigham Hospital in Boston, Massachusetts. The investigators were able to replicate the painful ecchymoses with intradermal injection of the patient’s own erythrocytes into the skin. They proposed that the underlying pathogenesis involved autosensitization to erythrocyte stroma.⁴ Since then, others have suggested that the pathogenesis may include autosensitization to erythrocyte phosphatidylserine, tonus dysregulation of venous capillaries, abnormal endothelial fibrin synthesis, and capillary wall instability.^5-7 

Histopathology typically reveals superficial and deep perivascular inflammation with extravasated erythrocytes. Direct immunofluorescence is negative for vasculitis.⁸ Diagnostics and laboratory findings for underlying systemic illness are negative or noncontributory. Cutaneous injection of 1 mL of the patient’s own washed erythrocytes may result in the formation of the characteristic painful plaques within 24 hours; however, this test is limited by lack of standardization and low sensitivity.³

Psychogenic purpura may share clinical features with cutaneous small vessel vasculitis, such as HSP or urticarial vasculitis. Some of the findings that our patient was experiencing, including purpura, arthralgia, and abdominal pain, are associated with HSP. However, HSP typically is self-limiting and classically features palpable purpura distributed across the lower extremities and buttocks. Histopathology demonstrates the classic findings of leukocytoclastic vasculitis; DIF typically is positive for perivascular IgA and C3 deposition. Increased serum IgA may be present.⁹ Urticarial vasculitis appears as erythematous indurated wheals that favor a proximal extremity and truncal distribution. They characteristically last longer than 24 hours, are frequently associated with nonprodromal pain or burning, and resolve with hyperpigmentation. Arthralgia and gastrointestinal, renal, pulmonary, cardiac, and neurologic symptoms may be present, especially in patients with low complement levels.¹⁰ Skin biopsy demonstrates leukocytoclasia that must be accompanied by vessel wall necrosis. Fibrinoid deposition, erythrocyte extravasation, or perivascular inflammation may be present. In 70% of cases revealing perivascular immunoglobulin, C3, and fibrinogen deposition, DIF is positive. Serum C1q autoantibody may be associated with the hypocomplementemic form.¹⁰

The classic histopathologic findings in leukocytoclastic vasculitis include transmural neutrophilic infiltration of the walls of small vessels, fibrinoid necrosis of vessel walls, leukocytoclasia, extravasated erythrocytes, and signs of endothelial cell damage.⁹ A prior punch biopsy in this patient demonstrated rare neutrophilic nuclear debris within the vessel walls without fibrin deposition. Although the presence of nuclear debris and extravasated erythrocytes could be compatible with a manifestation of urticarial vasculitis, the lack of direct evidence of vessel wall necrosis combined with subsequent biopsies unequivocally ruled out cutaneous small vessel vasculitis in our patient.

Psychogenic purpura has been reported to occur frequently in the background of psycho-emotional distress. In 1989, Ratnoff¹¹ noted that many of the patients he was treating at the University Hospitals of Cleveland, Ohio, had a depressive syndrome. A review of patients treated at the Mayo Clinic in Rochester, Minnesota, illustrated concomitant psychiatric illnesses in 41 of 76 (54%) patients treated for PP, most commonly depressive, personality, and anxiety disorders.³

There is no consensus on therapy for PP. Treatment is based on providing symptomatic relief and relieving underlying psychiatric distress. Block et al¹² found the use of selective serotonin reuptake inhibitors, tricyclic antidepressants, and psychotherapy to be successful in improving symptoms and reducing lesions at follow-up visits.

To the Editor:

A 14-year-old Black adolescent girl presented with episodic, painful, edematous plaques that occurred symmetrically on the arms and legs of 5 years’ duration. The plaques evolved into hyperpigmented patches within 24 to 48 hours before eventually resolving. Fatigue, headache, arthralgias of the arms and legs, chest pain, abdominal pain, nausea, and vomiting variably accompanied these episodes.

Prior to visiting our clinic, the patient had been seen by numerous specialists. A review of her medical records revealed an initial diagnosis of Henoch-Schönlein purpura (HSP), then urticarial vasculitis. She had been treated with antihistamines, topical and systemic steroids, hydroxychloroquine, mycophenolate mofetil, dapsone, azathioprine, and gabapentin. All treatments were ineffectual. She underwent extensive diagnostic testing and imaging, which were normal or noncontributory, including type I allergy testing; multiple exhaustive batteries of hematologic testing; and computed tomography/magnetic resonance imaging/magnetic resonance angiography of the brain, chest, abdomen, and pelvic region. Biopsies from symptomatic segments of the gastrointestinal tract were normal.

Chronic treatment with systemic steroids over 9 months resulted in gastritis and an episode of hematemesis requiring emergent hospitalization. A lengthy multidisciplinary evaluation was conducted at the patient’s local community hospital; the team concluded that she had an urticarial-type rash with accompanying symptoms that did not have an autoimmune, rheumatologic, or inflammatory basis.

The patient’s medical history was remarkable for recent-onset panic attacks. Her family medical history was noncontributory. Physical examination revealed multiple violaceous hyperpigmented patches diffusely located on the proximal upper arms (Figure 1). There were no additional findings on physical examination.

Punch biopsies were performed on lesional areas of the arm. Histopathology indicated a mild superficial perivascular dermal mixed infiltrate and extravasated erythrocytes (Figure 2). Direct immunofluorescence (DIF) testing was negative for vasculitis. Immunohistochemical stains for CD117 and tryptase demonstrated a slight increase in the number of dermal mast cells; however, the increase was not sufficient to diagnose cutaneous mastocytosis, which was in the differential. We proposed a diagnosis of psychogenic purpura (PP)(also known as Gardner-Diamond syndrome). She was treated with gabapentin, a selective serotonin reuptake inhibitor, and cognitive therapy. Unfortunately, after starting therapy the patient was lost to follow-up.

Psychogenic purpura is a rare vasculopathy of unknown etiology that may be a special form of factitious disorder.^1,2 In one study, PP occurred predominantly in females aged 15 to 66 years, with a median onset age of 33 years.³ A prodrome of localized itching, burning, and/or pain precedes the development of edematous plaques. The plaques evolve into painful ecchymoses within 1 to 2 days and resolve in 10 days or fewer without treatment. Lesions most commonly occur on the extremities but may occur anywhere on the body. The most common associated finding is an underlying depressive disorder. Episodes may be accompanied by headache, dizziness, fatigue, fever, arthralgia, nausea, vomiting, abdominal pain, menstrual irregularities, myalgia, and urologic conditions.

In 1955, Gardner and Diamond⁴ described the first cases of PP in 4 female patients at Peter Bent Brigham Hospital in Boston, Massachusetts. The investigators were able to replicate the painful ecchymoses with intradermal injection of the patient’s own erythrocytes into the skin. They proposed that the underlying pathogenesis involved autosensitization to erythrocyte stroma.⁴ Since then, others have suggested that the pathogenesis may include autosensitization to erythrocyte phosphatidylserine, tonus dysregulation of venous capillaries, abnormal endothelial fibrin synthesis, and capillary wall instability.^5-7 

Histopathology typically reveals superficial and deep perivascular inflammation with extravasated erythrocytes. Direct immunofluorescence is negative for vasculitis.⁸ Diagnostics and laboratory findings for underlying systemic illness are negative or noncontributory. Cutaneous injection of 1 mL of the patient’s own washed erythrocytes may result in the formation of the characteristic painful plaques within 24 hours; however, this test is limited by lack of standardization and low sensitivity.³

Psychogenic purpura may share clinical features with cutaneous small vessel vasculitis, such as HSP or urticarial vasculitis. Some of the findings that our patient was experiencing, including purpura, arthralgia, and abdominal pain, are associated with HSP. However, HSP typically is self-limiting and classically features palpable purpura distributed across the lower extremities and buttocks. Histopathology demonstrates the classic findings of leukocytoclastic vasculitis; DIF typically is positive for perivascular IgA and C3 deposition. Increased serum IgA may be present.⁹ Urticarial vasculitis appears as erythematous indurated wheals that favor a proximal extremity and truncal distribution. They characteristically last longer than 24 hours, are frequently associated with nonprodromal pain or burning, and resolve with hyperpigmentation. Arthralgia and gastrointestinal, renal, pulmonary, cardiac, and neurologic symptoms may be present, especially in patients with low complement levels.¹⁰ Skin biopsy demonstrates leukocytoclasia that must be accompanied by vessel wall necrosis. Fibrinoid deposition, erythrocyte extravasation, or perivascular inflammation may be present. In 70% of cases revealing perivascular immunoglobulin, C3, and fibrinogen deposition, DIF is positive. Serum C1q autoantibody may be associated with the hypocomplementemic form.¹⁰

The classic histopathologic findings in leukocytoclastic vasculitis include transmural neutrophilic infiltration of the walls of small vessels, fibrinoid necrosis of vessel walls, leukocytoclasia, extravasated erythrocytes, and signs of endothelial cell damage.⁹ A prior punch biopsy in this patient demonstrated rare neutrophilic nuclear debris within the vessel walls without fibrin deposition. Although the presence of nuclear debris and extravasated erythrocytes could be compatible with a manifestation of urticarial vasculitis, the lack of direct evidence of vessel wall necrosis combined with subsequent biopsies unequivocally ruled out cutaneous small vessel vasculitis in our patient.

Psychogenic purpura has been reported to occur frequently in the background of psycho-emotional distress. In 1989, Ratnoff¹¹ noted that many of the patients he was treating at the University Hospitals of Cleveland, Ohio, had a depressive syndrome. A review of patients treated at the Mayo Clinic in Rochester, Minnesota, illustrated concomitant psychiatric illnesses in 41 of 76 (54%) patients treated for PP, most commonly depressive, personality, and anxiety disorders.³

There is no consensus on therapy for PP. Treatment is based on providing symptomatic relief and relieving underlying psychiatric distress. Block et al¹² found the use of selective serotonin reuptake inhibitors, tricyclic antidepressants, and psychotherapy to be successful in improving symptoms and reducing lesions at follow-up visits.

To the Editor:

A 14-year-old Black adolescent girl presented with episodic, painful, edematous plaques that occurred symmetrically on the arms and legs of 5 years’ duration. The plaques evolved into hyperpigmented patches within 24 to 48 hours before eventually resolving. Fatigue, headache, arthralgias of the arms and legs, chest pain, abdominal pain, nausea, and vomiting variably accompanied these episodes.

Prior to visiting our clinic, the patient had been seen by numerous specialists. A review of her medical records revealed an initial diagnosis of Henoch-Schönlein purpura (HSP), then urticarial vasculitis. She had been treated with antihistamines, topical and systemic steroids, hydroxychloroquine, mycophenolate mofetil, dapsone, azathioprine, and gabapentin. All treatments were ineffectual. She underwent extensive diagnostic testing and imaging, which were normal or noncontributory, including type I allergy testing; multiple exhaustive batteries of hematologic testing; and computed tomography/magnetic resonance imaging/magnetic resonance angiography of the brain, chest, abdomen, and pelvic region. Biopsies from symptomatic segments of the gastrointestinal tract were normal.

Chronic treatment with systemic steroids over 9 months resulted in gastritis and an episode of hematemesis requiring emergent hospitalization. A lengthy multidisciplinary evaluation was conducted at the patient’s local community hospital; the team concluded that she had an urticarial-type rash with accompanying symptoms that did not have an autoimmune, rheumatologic, or inflammatory basis.

The patient’s medical history was remarkable for recent-onset panic attacks. Her family medical history was noncontributory. Physical examination revealed multiple violaceous hyperpigmented patches diffusely located on the proximal upper arms (Figure 1). There were no additional findings on physical examination.

Punch biopsies were performed on lesional areas of the arm. Histopathology indicated a mild superficial perivascular dermal mixed infiltrate and extravasated erythrocytes (Figure 2). Direct immunofluorescence (DIF) testing was negative for vasculitis. Immunohistochemical stains for CD117 and tryptase demonstrated a slight increase in the number of dermal mast cells; however, the increase was not sufficient to diagnose cutaneous mastocytosis, which was in the differential. We proposed a diagnosis of psychogenic purpura (PP)(also known as Gardner-Diamond syndrome). She was treated with gabapentin, a selective serotonin reuptake inhibitor, and cognitive therapy. Unfortunately, after starting therapy the patient was lost to follow-up.

Psychogenic purpura is a rare vasculopathy of unknown etiology that may be a special form of factitious disorder.^1,2 In one study, PP occurred predominantly in females aged 15 to 66 years, with a median onset age of 33 years.³ A prodrome of localized itching, burning, and/or pain precedes the development of edematous plaques. The plaques evolve into painful ecchymoses within 1 to 2 days and resolve in 10 days or fewer without treatment. Lesions most commonly occur on the extremities but may occur anywhere on the body. The most common associated finding is an underlying depressive disorder. Episodes may be accompanied by headache, dizziness, fatigue, fever, arthralgia, nausea, vomiting, abdominal pain, menstrual irregularities, myalgia, and urologic conditions.

In 1955, Gardner and Diamond⁴ described the first cases of PP in 4 female patients at Peter Bent Brigham Hospital in Boston, Massachusetts. The investigators were able to replicate the painful ecchymoses with intradermal injection of the patient’s own erythrocytes into the skin. They proposed that the underlying pathogenesis involved autosensitization to erythrocyte stroma.⁴ Since then, others have suggested that the pathogenesis may include autosensitization to erythrocyte phosphatidylserine, tonus dysregulation of venous capillaries, abnormal endothelial fibrin synthesis, and capillary wall instability.^5-7 

Histopathology typically reveals superficial and deep perivascular inflammation with extravasated erythrocytes. Direct immunofluorescence is negative for vasculitis.⁸ Diagnostics and laboratory findings for underlying systemic illness are negative or noncontributory. Cutaneous injection of 1 mL of the patient’s own washed erythrocytes may result in the formation of the characteristic painful plaques within 24 hours; however, this test is limited by lack of standardization and low sensitivity.³

Psychogenic purpura may share clinical features with cutaneous small vessel vasculitis, such as HSP or urticarial vasculitis. Some of the findings that our patient was experiencing, including purpura, arthralgia, and abdominal pain, are associated with HSP. However, HSP typically is self-limiting and classically features palpable purpura distributed across the lower extremities and buttocks. Histopathology demonstrates the classic findings of leukocytoclastic vasculitis; DIF typically is positive for perivascular IgA and C3 deposition. Increased serum IgA may be present.⁹ Urticarial vasculitis appears as erythematous indurated wheals that favor a proximal extremity and truncal distribution. They characteristically last longer than 24 hours, are frequently associated with nonprodromal pain or burning, and resolve with hyperpigmentation. Arthralgia and gastrointestinal, renal, pulmonary, cardiac, and neurologic symptoms may be present, especially in patients with low complement levels.¹⁰ Skin biopsy demonstrates leukocytoclasia that must be accompanied by vessel wall necrosis. Fibrinoid deposition, erythrocyte extravasation, or perivascular inflammation may be present. In 70% of cases revealing perivascular immunoglobulin, C3, and fibrinogen deposition, DIF is positive. Serum C1q autoantibody may be associated with the hypocomplementemic form.¹⁰

The classic histopathologic findings in leukocytoclastic vasculitis include transmural neutrophilic infiltration of the walls of small vessels, fibrinoid necrosis of vessel walls, leukocytoclasia, extravasated erythrocytes, and signs of endothelial cell damage.⁹ A prior punch biopsy in this patient demonstrated rare neutrophilic nuclear debris within the vessel walls without fibrin deposition. Although the presence of nuclear debris and extravasated erythrocytes could be compatible with a manifestation of urticarial vasculitis, the lack of direct evidence of vessel wall necrosis combined with subsequent biopsies unequivocally ruled out cutaneous small vessel vasculitis in our patient.

Psychogenic purpura has been reported to occur frequently in the background of psycho-emotional distress. In 1989, Ratnoff¹¹ noted that many of the patients he was treating at the University Hospitals of Cleveland, Ohio, had a depressive syndrome. A review of patients treated at the Mayo Clinic in Rochester, Minnesota, illustrated concomitant psychiatric illnesses in 41 of 76 (54%) patients treated for PP, most commonly depressive, personality, and anxiety disorders.³

There is no consensus on therapy for PP. Treatment is based on providing symptomatic relief and relieving underlying psychiatric distress. Block et al¹² found the use of selective serotonin reuptake inhibitors, tricyclic antidepressants, and psychotherapy to be successful in improving symptoms and reducing lesions at follow-up visits.