Finerenone, an investigational agent from a new drug class, just scored a second pivotal trial win after showing significant benefit for slowing progression of diabetic kidney disease in patients with type 2 diabetes in the FIDELIO-DKD pivotal trial with more than 5,700 patients.

Top-line results from FIGARO-DKD showed significant benefit for the primary endpoint of cardiovascular death and nonfatal cardiovascular disease endpoints in a placebo-controlled trial with about 7,400 patients with type 2 diabetes, reported Bayer, the company developing finerenone in statement released on May 10, 2021.

Based on the FIDELIO-DKD results, finerenone is currently under review by the U.S. Food and Drug Administration for marketing approval as a treatment for patients with type 2 diabetes and chronic kidney disease. FIDELIO-DKD, in addition to the primary endpoint that focused on slowing progression of diabetic kidney disease, had a secondary endpoint that assessed the combined incidence on treatment of cardiovascular death, or nonfatal episodes of stroke, MI, or hospitalization for heart failure. Results from the study published in 2020 in the New England Journal of Medicine showed that finerenone was safe and effective for both endpoints.

In the current study, FIGARO-DKD, run at more than 1,000 sites in 47 countries, these endpoints flipped. The primary outcome was a composite of cardiovascular death or nonfatal cardiovascular disease events, and the secondary outcome was prevention of DKD progression.

Other than stating the results significantly fulfilled FIGARO-DKD’s primary endpoint of reducing the incidence of combined cardiovascular disease endpoints, the release gave no further outcome details. The release noted that the enrolled patient cohort in FIGARO-DKD included more patients with earlier-stage chronic kidney disease, compared with FIDELIO-DKD.

Finerenone is a first-in-class investigational nonsteroidal, selective mineralocorticoid receptor antagonist (MRA). As an MRA it shares certain activities with the steroidal MRAs spironolactone and eplerenone. But the absence of a steroidal structure means that finerenone does not cause steroidal adverse effects such as gynecomastia. Results in FIDELIO-DKD showed that finerenone caused more hyperkalemia than placebo, but the level of hyperkalemia that it causes relative to spironolactone or eplerenone remains uncertain.

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Finerenone, an investigational agent from a new drug class, just scored a second pivotal trial win after showing significant benefit for slowing progression of diabetic kidney disease in patients with type 2 diabetes in the FIDELIO-DKD pivotal trial with more than 5,700 patients.

Top-line results from FIGARO-DKD showed significant benefit for the primary endpoint of cardiovascular death and nonfatal cardiovascular disease endpoints in a placebo-controlled trial with about 7,400 patients with type 2 diabetes, reported Bayer, the company developing finerenone in statement released on May 10, 2021.

Based on the FIDELIO-DKD results, finerenone is currently under review by the U.S. Food and Drug Administration for marketing approval as a treatment for patients with type 2 diabetes and chronic kidney disease. FIDELIO-DKD, in addition to the primary endpoint that focused on slowing progression of diabetic kidney disease, had a secondary endpoint that assessed the combined incidence on treatment of cardiovascular death, or nonfatal episodes of stroke, MI, or hospitalization for heart failure. Results from the study published in 2020 in the New England Journal of Medicine showed that finerenone was safe and effective for both endpoints.

In the current study, FIGARO-DKD, run at more than 1,000 sites in 47 countries, these endpoints flipped. The primary outcome was a composite of cardiovascular death or nonfatal cardiovascular disease events, and the secondary outcome was prevention of DKD progression.

Other than stating the results significantly fulfilled FIGARO-DKD’s primary endpoint of reducing the incidence of combined cardiovascular disease endpoints, the release gave no further outcome details. The release noted that the enrolled patient cohort in FIGARO-DKD included more patients with earlier-stage chronic kidney disease, compared with FIDELIO-DKD.

Finerenone is a first-in-class investigational nonsteroidal, selective mineralocorticoid receptor antagonist (MRA). As an MRA it shares certain activities with the steroidal MRAs spironolactone and eplerenone. But the absence of a steroidal structure means that finerenone does not cause steroidal adverse effects such as gynecomastia. Results in FIDELIO-DKD showed that finerenone caused more hyperkalemia than placebo, but the level of hyperkalemia that it causes relative to spironolactone or eplerenone remains uncertain.

[email protected]

Finerenone, an investigational agent from a new drug class, just scored a second pivotal trial win after showing significant benefit for slowing progression of diabetic kidney disease in patients with type 2 diabetes in the FIDELIO-DKD pivotal trial with more than 5,700 patients.

Top-line results from FIGARO-DKD showed significant benefit for the primary endpoint of cardiovascular death and nonfatal cardiovascular disease endpoints in a placebo-controlled trial with about 7,400 patients with type 2 diabetes, reported Bayer, the company developing finerenone in statement released on May 10, 2021.

Based on the FIDELIO-DKD results, finerenone is currently under review by the U.S. Food and Drug Administration for marketing approval as a treatment for patients with type 2 diabetes and chronic kidney disease. FIDELIO-DKD, in addition to the primary endpoint that focused on slowing progression of diabetic kidney disease, had a secondary endpoint that assessed the combined incidence on treatment of cardiovascular death, or nonfatal episodes of stroke, MI, or hospitalization for heart failure. Results from the study published in 2020 in the New England Journal of Medicine showed that finerenone was safe and effective for both endpoints.

In the current study, FIGARO-DKD, run at more than 1,000 sites in 47 countries, these endpoints flipped. The primary outcome was a composite of cardiovascular death or nonfatal cardiovascular disease events, and the secondary outcome was prevention of DKD progression.

Other than stating the results significantly fulfilled FIGARO-DKD’s primary endpoint of reducing the incidence of combined cardiovascular disease endpoints, the release gave no further outcome details. The release noted that the enrolled patient cohort in FIGARO-DKD included more patients with earlier-stage chronic kidney disease, compared with FIDELIO-DKD.

Finerenone is a first-in-class investigational nonsteroidal, selective mineralocorticoid receptor antagonist (MRA). As an MRA it shares certain activities with the steroidal MRAs spironolactone and eplerenone. But the absence of a steroidal structure means that finerenone does not cause steroidal adverse effects such as gynecomastia. Results in FIDELIO-DKD showed that finerenone caused more hyperkalemia than placebo, but the level of hyperkalemia that it causes relative to spironolactone or eplerenone remains uncertain.

[email protected]

For patients with mild or remitted ulcerative colitis, a catered, low-fat, high-fiber diet improved quality of life and stool markers of dysbiosis and inflammation, according to the findings of a small crossover trial.

Lisovskaya/iStock/Getty Images

Patients with inflammatory bowel disease often ask what they should eat, but few studies have addressed that question, Julia Fritsch, of the University of Miami and her associates wrote in Clinical Gastroenterology and Hepatology. Building on previous findings that a high-fat diet may contribute to inflammatory bowel disease, they randomly assigned 38 adults whose ulcerative colitis was in remission or mild (with a flare within the past 18 months) to receive either a low-fat diet (with 10% of daily calories from fat and high amounts of fruit and vegetables) or an “improved American standard diet” (with 35%-40% of daily calories from fat but more fruit and vegetables than Americans typically eat). Each diet was catered, delivered to patients’ homes, and lasted 4 weeks, followed by a 2-week washout period, after which each participant switched to the other diet.

Of the 38 patients, 17 completed the study. Food recall surveys over 24 hours showed that both diets were healthier than what participants ate at baseline, and daily web-based food diaries (such as www.nutrihand.com/Static/index.html) confirmed that more than 94% of patients adhered to the amount of fat in each diet. Even though participants in both groups ate only about half of the provided fruits and vegetables, the primary outcome of quality of life based on the short inflammatory bowel disease questionnaire (SIBDQ) significantly improved from a median of 4.98 (interquartile range, 4.1-6.0) at baseline to 5.77 (IQR, 5-6.4) with the low-fat diet and 5.55 (IQR, 4.75-6.25) with the improved American standard diet. Both diets also produced significant improvements in quality of life as measured by the 36-Item Short Form Survey and in disease activity as measured by the partial Mayo score.

Notably, however, only the low-fat diet significantly reduced serum amyloid A, which is a marker of mucosal inflammation, and intestinal dysbiosis, which was quantified by 16S RNA ribosomal sequencing. “Of note, there were several variables that were associated with changes in the microbiota composition,” the researchers wrote. These included the SIBDQ, C-reactive protein, interleukin-6, interleukin-1 beta, and 32 dietary components such as protein, potassium, iron, and zinc.

“These data suggest that even patients in remission [from ulcerative colitis] could benefit from a healthier diet,” the investigators concluded. “Just as importantly, neither diet exacerbated symptoms, which is notable given the higher fiber in both catered diets.” They called catering “a feasible way to perform a diet intervention study with high adherence,” noting that “catering a diet for a patient with IBD for a year costs between $19,000 and $21,000 per patient. The cost of a patient on a biologic such as ustekinumab is approximately $130,752 to $261,504.”

The study was supported by the Crohn’s and Colitis Foundation Broad Medical Research Program, Micky and Madeleine Arison Family Foundation Crohn’s and Colitis Discovery Laboratory, and the Martin Kalser Chair. The senior author disclosed ties to Boehringer Ingelheim, Gilead, AbbVie, Seres Therapeutics, Shire, Landos, Pfizer, and several other pharmaceutical companies. The other researchers reported having no conflicts of interest.

For patients with mild or remitted ulcerative colitis, a catered, low-fat, high-fiber diet improved quality of life and stool markers of dysbiosis and inflammation, according to the findings of a small crossover trial.

Lisovskaya/iStock/Getty Images

Patients with inflammatory bowel disease often ask what they should eat, but few studies have addressed that question, Julia Fritsch, of the University of Miami and her associates wrote in Clinical Gastroenterology and Hepatology. Building on previous findings that a high-fat diet may contribute to inflammatory bowel disease, they randomly assigned 38 adults whose ulcerative colitis was in remission or mild (with a flare within the past 18 months) to receive either a low-fat diet (with 10% of daily calories from fat and high amounts of fruit and vegetables) or an “improved American standard diet” (with 35%-40% of daily calories from fat but more fruit and vegetables than Americans typically eat). Each diet was catered, delivered to patients’ homes, and lasted 4 weeks, followed by a 2-week washout period, after which each participant switched to the other diet.

Of the 38 patients, 17 completed the study. Food recall surveys over 24 hours showed that both diets were healthier than what participants ate at baseline, and daily web-based food diaries (such as www.nutrihand.com/Static/index.html) confirmed that more than 94% of patients adhered to the amount of fat in each diet. Even though participants in both groups ate only about half of the provided fruits and vegetables, the primary outcome of quality of life based on the short inflammatory bowel disease questionnaire (SIBDQ) significantly improved from a median of 4.98 (interquartile range, 4.1-6.0) at baseline to 5.77 (IQR, 5-6.4) with the low-fat diet and 5.55 (IQR, 4.75-6.25) with the improved American standard diet. Both diets also produced significant improvements in quality of life as measured by the 36-Item Short Form Survey and in disease activity as measured by the partial Mayo score.

Notably, however, only the low-fat diet significantly reduced serum amyloid A, which is a marker of mucosal inflammation, and intestinal dysbiosis, which was quantified by 16S RNA ribosomal sequencing. “Of note, there were several variables that were associated with changes in the microbiota composition,” the researchers wrote. These included the SIBDQ, C-reactive protein, interleukin-6, interleukin-1 beta, and 32 dietary components such as protein, potassium, iron, and zinc.

“These data suggest that even patients in remission [from ulcerative colitis] could benefit from a healthier diet,” the investigators concluded. “Just as importantly, neither diet exacerbated symptoms, which is notable given the higher fiber in both catered diets.” They called catering “a feasible way to perform a diet intervention study with high adherence,” noting that “catering a diet for a patient with IBD for a year costs between $19,000 and $21,000 per patient. The cost of a patient on a biologic such as ustekinumab is approximately $130,752 to $261,504.”

The study was supported by the Crohn’s and Colitis Foundation Broad Medical Research Program, Micky and Madeleine Arison Family Foundation Crohn’s and Colitis Discovery Laboratory, and the Martin Kalser Chair. The senior author disclosed ties to Boehringer Ingelheim, Gilead, AbbVie, Seres Therapeutics, Shire, Landos, Pfizer, and several other pharmaceutical companies. The other researchers reported having no conflicts of interest.

For patients with mild or remitted ulcerative colitis, a catered, low-fat, high-fiber diet improved quality of life and stool markers of dysbiosis and inflammation, according to the findings of a small crossover trial.

Lisovskaya/iStock/Getty Images

Patients with inflammatory bowel disease often ask what they should eat, but few studies have addressed that question, Julia Fritsch, of the University of Miami and her associates wrote in Clinical Gastroenterology and Hepatology. Building on previous findings that a high-fat diet may contribute to inflammatory bowel disease, they randomly assigned 38 adults whose ulcerative colitis was in remission or mild (with a flare within the past 18 months) to receive either a low-fat diet (with 10% of daily calories from fat and high amounts of fruit and vegetables) or an “improved American standard diet” (with 35%-40% of daily calories from fat but more fruit and vegetables than Americans typically eat). Each diet was catered, delivered to patients’ homes, and lasted 4 weeks, followed by a 2-week washout period, after which each participant switched to the other diet.

Of the 38 patients, 17 completed the study. Food recall surveys over 24 hours showed that both diets were healthier than what participants ate at baseline, and daily web-based food diaries (such as www.nutrihand.com/Static/index.html) confirmed that more than 94% of patients adhered to the amount of fat in each diet. Even though participants in both groups ate only about half of the provided fruits and vegetables, the primary outcome of quality of life based on the short inflammatory bowel disease questionnaire (SIBDQ) significantly improved from a median of 4.98 (interquartile range, 4.1-6.0) at baseline to 5.77 (IQR, 5-6.4) with the low-fat diet and 5.55 (IQR, 4.75-6.25) with the improved American standard diet. Both diets also produced significant improvements in quality of life as measured by the 36-Item Short Form Survey and in disease activity as measured by the partial Mayo score.

Notably, however, only the low-fat diet significantly reduced serum amyloid A, which is a marker of mucosal inflammation, and intestinal dysbiosis, which was quantified by 16S RNA ribosomal sequencing. “Of note, there were several variables that were associated with changes in the microbiota composition,” the researchers wrote. These included the SIBDQ, C-reactive protein, interleukin-6, interleukin-1 beta, and 32 dietary components such as protein, potassium, iron, and zinc.

“These data suggest that even patients in remission [from ulcerative colitis] could benefit from a healthier diet,” the investigators concluded. “Just as importantly, neither diet exacerbated symptoms, which is notable given the higher fiber in both catered diets.” They called catering “a feasible way to perform a diet intervention study with high adherence,” noting that “catering a diet for a patient with IBD for a year costs between $19,000 and $21,000 per patient. The cost of a patient on a biologic such as ustekinumab is approximately $130,752 to $261,504.”

The study was supported by the Crohn’s and Colitis Foundation Broad Medical Research Program, Micky and Madeleine Arison Family Foundation Crohn’s and Colitis Discovery Laboratory, and the Martin Kalser Chair. The senior author disclosed ties to Boehringer Ingelheim, Gilead, AbbVie, Seres Therapeutics, Shire, Landos, Pfizer, and several other pharmaceutical companies. The other researchers reported having no conflicts of interest.

Initiatives targeting hypoglycemia and insulin pen wastage could lead to dramatic cost savings in small community hospitals, new data suggest.

The two projects are part of a dedicated inpatient glucose management service led by Mihail (“Misha”) Zilbermint, MD, one of the few full-time endocrine hospitalists in the United States and one of even fewer who work at a small community hospital.

In 2019, Dr. Zilbermint and colleagues reported that their inpatient glucose management program resulted in a 27% reduction in length of stay and a 10.7% lower 30-day readmission rate. The projected cost savings for the period January 2016 to May 2017 was $953,578.

Dr. Zilbermint’s team has written two new articles that document cost savings for specific elements of the program; namely, a set of hospital-wide hypoglycemia prevention measures, and an initiative that reduced duplicate inpatient insulin pen dispensing.

About 1 in 4 people in U.S. hospitals have diabetes or hyperglycemia. Large academic hospitals have endocrine divisions and training programs, but 85% of people receive care at small community hospitals.

“There are management guidelines, but they’re not always followed ... That’s why I’ve been advocating for endocrine hospitalists to be deployed nationally,” Dr. Zilbermint said. He is chief and director of endocrinology, diabetes, and metabolism at Johns Hopkins Community Physicians at Suburban Hospital, Bethesda, Maryland.

Asked to comment on behalf of the Society of Hospital Medicine (SHM), Greg Maynard, MD, program lead for SHM’s Electronic Quality Improvement Programs, said that Suburban’s overall program goals align with those of the SHM.

“Dedicated inpatient glycemic control teams are very important and desirable to improve the quality and safety of care for inpatients with hyperglycemia and diabetes,” he said.

Regarding specific initiatives, such as those aimed at reducing hypoglycemia and insulin pen wastage, Dr. Maynard said, “All of these are feasible in a wide variety of institutions. The main barrier is getting the institutional support for people to work on these interventions. This series of studies can help spread the word about the positive return on investment.”

Another barrier – the current lack of publicly reported measures or pay-for-performance programs for hypoglycemia prevention and glycemic control – may soon change, added Dr. Maynard, who is also chief quality officer at the University of California, Davis, Medical Center.

“The National Quality Forum has endorsed new measures, and the CDC’s National Healthcare Safety Network is working on ways to augment those measures and embed them into their infrastructure,” he said.

Although SHM doesn’t specifically endorse full-time glycemic control hospitalists over endocrinology-trained glycemic control experts, “certainly hospitalists who accrue added training are very well positioned to be an important part of these interdisciplinary teams,” Dr. Maynard said.
 

‘The nurses were so afraid of hypoglycemia’

Tackling hypoglycemia was Dr. Zilbermint’s first priority when he started the glycemic management program at Suburban in late 2015.

“One of the most common complaints from the nurses was that a lot of their patients had hypoglycemia, especially in the ICU, when patients were placed on insulin infusion protocols ... Every time, the nurse would have to call the attending and ask what to do,” he explains.

In addition, Dr. Zilbermint says, there was no standard for treating hypoglycemia. A nurse in one unit would give two cups of juice, another a 50% dextrose infusion, or another, milk. Even more concerning, “the nurses were so afraid of hypoglycemia they would reflexively discontinue all insulin, including basal.”

So one of the new initiatives, led by Carter Shelton, MSHCM, an administrative fellow at the Medical University of South Carolina, Charleston, was to implement a set of hospital-wide hypoglycemia prevention measures, as described in an article published online April 21 in the Journal of Diabetes Science and Technology.
 

Inpatient hypoglycemia rate was cut nearly in half

This began in 2016, when the multidisciplinary Suburban Hospital Glucose Steering Committee identified four main causes of insulin-induced hypoglycemia (defined as a blood glucose level of ≤70 mg/dL in a patient who had received at least one dose of insulin in the past 24 hours) and devised solutions for each:

1. Lack of a unified hypoglycemia protocol. A formal, evidence-based, nurse-driven treatment protocol with clinical decision support in the electronic medical record was developed. The Suburban team adapted much of the protocol from one that had been recently implemented at the flagship Johns Hopkins Hospital, in Baltimore, Maryland.

According to that protocol, if patients are able to swallow, they are given 15 g or 30 g of carbohydrates in order to achieve a blood glucose level of 50 to 70 mg/dL and <50 mg/dL, respectively. Levels are checked 15 minutes later. Intravenous D50 or glucagon is reserved for patients who can’t swallow.

2. For patients in critical care, the insulin infusion protocol that had been in use set blood glucose targets of 80 to 110 mg/dL, which resulted in hypoglycemia in nearly every patient who received an insulin infusion. This protocol was changed to the currently recommended 140 to 180 mg/dL.

3. Most patients were managed with sliding-scale insulin, an outdated yet still widely used regimen whereby insulin is given based only on current blood glucose without accounting for carbohydrates consumed with meals and not corrected until the subsequent meal. This was changed so that nurses give insulin after the patient has consumed at least 50% of their meal carbohydrates.

4. Lack of hypoglycemia reporting. A glucometrics dashboard – now used throughout the Johns Hopkins system – was adopted to produce daily hypoglycemia reports in the EMR system that could be reviewed by the inpatient glucose management service to track quality metrics and plan further interventions.

Between Jan. 1, 2016, and Sept. 30, 2019, out of a total 49,315 patient-days, there were 2,682 days on which any hypoglycemia occurred and 874 days on which moderate hypoglycemia occurred (≤54 mg/dL). Type 2 diabetes accounted for 84.4% of the total patient-days; type 1 accounted for 4.4%.

The overall frequency of any hypoglycemia patient-days per month decreased from 7.5% to 3.9% during the study period (P = .001). This was significant for the patients with type 2 diabetes (7.4% to 3.8%; P < .0001) but not for those with type 1 diabetes (18.5% to 18.0%; P = .08).

Rates of moderate hypoglycemia also decreased significantly among the patients with type 2 diabetes (1.9% to 1.0%; P = .03) but not for those with type 1 diabetes (7.4% to 6.0%; P = .14).

On the basis of these rates in reducing hypoglycemia, in which the inpatient hypoglycemia rate was cut nearly in half, the estimated savings in cost of care to the hospital was $98,635 during the period of January 2016 to September 2019.
 

Reducing insulin pen waste by minimizing duplicate prescriptions

Suburban Hospital had been using insulin vials and syringes when Dr. Zilbermint first arrived there. He lobbied the administration to allow use of pens, because they’re easier to use and they reduce the risk for needlestick injuries. Nurses were educated and retrained monthly in their use.

The switch to pens – aspart (Novolog Flexpen) for bolus insulin and glargine (Lantus SoloSTAR) – took place in 2018. The cost of the aspart pen was $16.19, and the cost of glargine was $25.08. Each holds 300 units of insulin.

After the first month, the team noticed a large increase in expenses. A quality improvement project was devised to address the issue.

“We were dispensing sometimes three or four pens per person. That’s a lot. Each pen holds 300 units, so one pen should last the entire hospital stay of an average 4- or 5-day stay,” Dr. Zilbermint explained. “We had to figure out where we were bleeding the money and where the pens were going.”

When pens disappeared, the pharmacy would have to dispense new ones. One problem was that when patients were transferred from one unit to another, the pen would be left behind and the room would be cleaned. Sometimes the pens weren’t stored properly or were misplaced. Often, they’d end up in a nurse’s pocket.

The second intervention was led by Urooj Najmi, MD, of the American International School of Medicine, Atlanta, Georgia. A program was instituted to reduce duplicate inpatient insulin pen dispensing, as detailed in an article published in the same issue of the Journal of Diabetes Science and Technology.

Solutions to reduce duplicate pen dispensing included having pharmacy track daily insulin pen reports and monitor duplicate orders, with “do not dispense” instructions conveyed via the EMR system. All multidose medications, including insulin pens, were to be placed in patients’ bins at the nursing station, and nurses were instructed to look for patients’ insulin pens prior to their being transferred to another unit, rather than ask for a replacement pen.

From July 2018 to July 2019, 3,121 patients received insulin, of whom 95% received aspart and 47% received glargine. Of the 9,516 pens dispensed, 68% were for aspart and 32% were for glargine. During the study period, the number of pens dispensed per patient dropped from 2.2 to 1.2 for aspart and from 2.1 to 1.3 for glargine; differences were highly significant (P = .0002 and P = .0005, respectively).

The total amount of unnecessary dispensing during the first 4 months after initiating the pen implementation program was 58%. The average monthly cost was $11,820.68; the projected cost per year was $141,848.

Six months after the waste reduction strategies were implemented, monthly waste had dropped to 42%, translating to an estimated potential cost savings of $66,261 over 12 months.

Because Suburban Hospital doesn’t have an outpatient dispensing license, there is still wastage when patients are discharged, because they can’t take their pens home with them. That remains a challenge, Dr. Zilbermint noted.

The team is working on implementing automatic A1c testing for patients admitted with hyperglycemia who either have a history of diabetes or whose blood glucose level is >140 mg/dL. Dr. Zilbermint said, “it’s in the guidelines, but it’s not always done.”

Dr. Zilbermint is a consultant for Guidepoint. Dr. Maynard, Mr. Shelton, and Dr. Najmi have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Initiatives targeting hypoglycemia and insulin pen wastage could lead to dramatic cost savings in small community hospitals, new data suggest.

The two projects are part of a dedicated inpatient glucose management service led by Mihail (“Misha”) Zilbermint, MD, one of the few full-time endocrine hospitalists in the United States and one of even fewer who work at a small community hospital.

In 2019, Dr. Zilbermint and colleagues reported that their inpatient glucose management program resulted in a 27% reduction in length of stay and a 10.7% lower 30-day readmission rate. The projected cost savings for the period January 2016 to May 2017 was $953,578.

Dr. Zilbermint’s team has written two new articles that document cost savings for specific elements of the program; namely, a set of hospital-wide hypoglycemia prevention measures, and an initiative that reduced duplicate inpatient insulin pen dispensing.

About 1 in 4 people in U.S. hospitals have diabetes or hyperglycemia. Large academic hospitals have endocrine divisions and training programs, but 85% of people receive care at small community hospitals.

“There are management guidelines, but they’re not always followed ... That’s why I’ve been advocating for endocrine hospitalists to be deployed nationally,” Dr. Zilbermint said. He is chief and director of endocrinology, diabetes, and metabolism at Johns Hopkins Community Physicians at Suburban Hospital, Bethesda, Maryland.

Asked to comment on behalf of the Society of Hospital Medicine (SHM), Greg Maynard, MD, program lead for SHM’s Electronic Quality Improvement Programs, said that Suburban’s overall program goals align with those of the SHM.

“Dedicated inpatient glycemic control teams are very important and desirable to improve the quality and safety of care for inpatients with hyperglycemia and diabetes,” he said.

Regarding specific initiatives, such as those aimed at reducing hypoglycemia and insulin pen wastage, Dr. Maynard said, “All of these are feasible in a wide variety of institutions. The main barrier is getting the institutional support for people to work on these interventions. This series of studies can help spread the word about the positive return on investment.”

Another barrier – the current lack of publicly reported measures or pay-for-performance programs for hypoglycemia prevention and glycemic control – may soon change, added Dr. Maynard, who is also chief quality officer at the University of California, Davis, Medical Center.

“The National Quality Forum has endorsed new measures, and the CDC’s National Healthcare Safety Network is working on ways to augment those measures and embed them into their infrastructure,” he said.

Although SHM doesn’t specifically endorse full-time glycemic control hospitalists over endocrinology-trained glycemic control experts, “certainly hospitalists who accrue added training are very well positioned to be an important part of these interdisciplinary teams,” Dr. Maynard said.
 

‘The nurses were so afraid of hypoglycemia’

Tackling hypoglycemia was Dr. Zilbermint’s first priority when he started the glycemic management program at Suburban in late 2015.

“One of the most common complaints from the nurses was that a lot of their patients had hypoglycemia, especially in the ICU, when patients were placed on insulin infusion protocols ... Every time, the nurse would have to call the attending and ask what to do,” he explains.

In addition, Dr. Zilbermint says, there was no standard for treating hypoglycemia. A nurse in one unit would give two cups of juice, another a 50% dextrose infusion, or another, milk. Even more concerning, “the nurses were so afraid of hypoglycemia they would reflexively discontinue all insulin, including basal.”

So one of the new initiatives, led by Carter Shelton, MSHCM, an administrative fellow at the Medical University of South Carolina, Charleston, was to implement a set of hospital-wide hypoglycemia prevention measures, as described in an article published online April 21 in the Journal of Diabetes Science and Technology.
 

Inpatient hypoglycemia rate was cut nearly in half

This began in 2016, when the multidisciplinary Suburban Hospital Glucose Steering Committee identified four main causes of insulin-induced hypoglycemia (defined as a blood glucose level of ≤70 mg/dL in a patient who had received at least one dose of insulin in the past 24 hours) and devised solutions for each:

1. Lack of a unified hypoglycemia protocol. A formal, evidence-based, nurse-driven treatment protocol with clinical decision support in the electronic medical record was developed. The Suburban team adapted much of the protocol from one that had been recently implemented at the flagship Johns Hopkins Hospital, in Baltimore, Maryland.

According to that protocol, if patients are able to swallow, they are given 15 g or 30 g of carbohydrates in order to achieve a blood glucose level of 50 to 70 mg/dL and <50 mg/dL, respectively. Levels are checked 15 minutes later. Intravenous D50 or glucagon is reserved for patients who can’t swallow.

2. For patients in critical care, the insulin infusion protocol that had been in use set blood glucose targets of 80 to 110 mg/dL, which resulted in hypoglycemia in nearly every patient who received an insulin infusion. This protocol was changed to the currently recommended 140 to 180 mg/dL.

3. Most patients were managed with sliding-scale insulin, an outdated yet still widely used regimen whereby insulin is given based only on current blood glucose without accounting for carbohydrates consumed with meals and not corrected until the subsequent meal. This was changed so that nurses give insulin after the patient has consumed at least 50% of their meal carbohydrates.

4. Lack of hypoglycemia reporting. A glucometrics dashboard – now used throughout the Johns Hopkins system – was adopted to produce daily hypoglycemia reports in the EMR system that could be reviewed by the inpatient glucose management service to track quality metrics and plan further interventions.

Between Jan. 1, 2016, and Sept. 30, 2019, out of a total 49,315 patient-days, there were 2,682 days on which any hypoglycemia occurred and 874 days on which moderate hypoglycemia occurred (≤54 mg/dL). Type 2 diabetes accounted for 84.4% of the total patient-days; type 1 accounted for 4.4%.

The overall frequency of any hypoglycemia patient-days per month decreased from 7.5% to 3.9% during the study period (P = .001). This was significant for the patients with type 2 diabetes (7.4% to 3.8%; P < .0001) but not for those with type 1 diabetes (18.5% to 18.0%; P = .08).

Rates of moderate hypoglycemia also decreased significantly among the patients with type 2 diabetes (1.9% to 1.0%; P = .03) but not for those with type 1 diabetes (7.4% to 6.0%; P = .14).

On the basis of these rates in reducing hypoglycemia, in which the inpatient hypoglycemia rate was cut nearly in half, the estimated savings in cost of care to the hospital was $98,635 during the period of January 2016 to September 2019.
 

Reducing insulin pen waste by minimizing duplicate prescriptions

Suburban Hospital had been using insulin vials and syringes when Dr. Zilbermint first arrived there. He lobbied the administration to allow use of pens, because they’re easier to use and they reduce the risk for needlestick injuries. Nurses were educated and retrained monthly in their use.

The switch to pens – aspart (Novolog Flexpen) for bolus insulin and glargine (Lantus SoloSTAR) – took place in 2018. The cost of the aspart pen was $16.19, and the cost of glargine was $25.08. Each holds 300 units of insulin.

After the first month, the team noticed a large increase in expenses. A quality improvement project was devised to address the issue.

“We were dispensing sometimes three or four pens per person. That’s a lot. Each pen holds 300 units, so one pen should last the entire hospital stay of an average 4- or 5-day stay,” Dr. Zilbermint explained. “We had to figure out where we were bleeding the money and where the pens were going.”

When pens disappeared, the pharmacy would have to dispense new ones. One problem was that when patients were transferred from one unit to another, the pen would be left behind and the room would be cleaned. Sometimes the pens weren’t stored properly or were misplaced. Often, they’d end up in a nurse’s pocket.

The second intervention was led by Urooj Najmi, MD, of the American International School of Medicine, Atlanta, Georgia. A program was instituted to reduce duplicate inpatient insulin pen dispensing, as detailed in an article published in the same issue of the Journal of Diabetes Science and Technology.

Solutions to reduce duplicate pen dispensing included having pharmacy track daily insulin pen reports and monitor duplicate orders, with “do not dispense” instructions conveyed via the EMR system. All multidose medications, including insulin pens, were to be placed in patients’ bins at the nursing station, and nurses were instructed to look for patients’ insulin pens prior to their being transferred to another unit, rather than ask for a replacement pen.

From July 2018 to July 2019, 3,121 patients received insulin, of whom 95% received aspart and 47% received glargine. Of the 9,516 pens dispensed, 68% were for aspart and 32% were for glargine. During the study period, the number of pens dispensed per patient dropped from 2.2 to 1.2 for aspart and from 2.1 to 1.3 for glargine; differences were highly significant (P = .0002 and P = .0005, respectively).

The total amount of unnecessary dispensing during the first 4 months after initiating the pen implementation program was 58%. The average monthly cost was $11,820.68; the projected cost per year was $141,848.

Six months after the waste reduction strategies were implemented, monthly waste had dropped to 42%, translating to an estimated potential cost savings of $66,261 over 12 months.

Because Suburban Hospital doesn’t have an outpatient dispensing license, there is still wastage when patients are discharged, because they can’t take their pens home with them. That remains a challenge, Dr. Zilbermint noted.

The team is working on implementing automatic A1c testing for patients admitted with hyperglycemia who either have a history of diabetes or whose blood glucose level is >140 mg/dL. Dr. Zilbermint said, “it’s in the guidelines, but it’s not always done.”

Dr. Zilbermint is a consultant for Guidepoint. Dr. Maynard, Mr. Shelton, and Dr. Najmi have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Initiatives targeting hypoglycemia and insulin pen wastage could lead to dramatic cost savings in small community hospitals, new data suggest.

The two projects are part of a dedicated inpatient glucose management service led by Mihail (“Misha”) Zilbermint, MD, one of the few full-time endocrine hospitalists in the United States and one of even fewer who work at a small community hospital.

In 2019, Dr. Zilbermint and colleagues reported that their inpatient glucose management program resulted in a 27% reduction in length of stay and a 10.7% lower 30-day readmission rate. The projected cost savings for the period January 2016 to May 2017 was $953,578.

Dr. Zilbermint’s team has written two new articles that document cost savings for specific elements of the program; namely, a set of hospital-wide hypoglycemia prevention measures, and an initiative that reduced duplicate inpatient insulin pen dispensing.

About 1 in 4 people in U.S. hospitals have diabetes or hyperglycemia. Large academic hospitals have endocrine divisions and training programs, but 85% of people receive care at small community hospitals.

“There are management guidelines, but they’re not always followed ... That’s why I’ve been advocating for endocrine hospitalists to be deployed nationally,” Dr. Zilbermint said. He is chief and director of endocrinology, diabetes, and metabolism at Johns Hopkins Community Physicians at Suburban Hospital, Bethesda, Maryland.

Asked to comment on behalf of the Society of Hospital Medicine (SHM), Greg Maynard, MD, program lead for SHM’s Electronic Quality Improvement Programs, said that Suburban’s overall program goals align with those of the SHM.

“Dedicated inpatient glycemic control teams are very important and desirable to improve the quality and safety of care for inpatients with hyperglycemia and diabetes,” he said.

Regarding specific initiatives, such as those aimed at reducing hypoglycemia and insulin pen wastage, Dr. Maynard said, “All of these are feasible in a wide variety of institutions. The main barrier is getting the institutional support for people to work on these interventions. This series of studies can help spread the word about the positive return on investment.”

Another barrier – the current lack of publicly reported measures or pay-for-performance programs for hypoglycemia prevention and glycemic control – may soon change, added Dr. Maynard, who is also chief quality officer at the University of California, Davis, Medical Center.

“The National Quality Forum has endorsed new measures, and the CDC’s National Healthcare Safety Network is working on ways to augment those measures and embed them into their infrastructure,” he said.

Although SHM doesn’t specifically endorse full-time glycemic control hospitalists over endocrinology-trained glycemic control experts, “certainly hospitalists who accrue added training are very well positioned to be an important part of these interdisciplinary teams,” Dr. Maynard said.
 

‘The nurses were so afraid of hypoglycemia’

Tackling hypoglycemia was Dr. Zilbermint’s first priority when he started the glycemic management program at Suburban in late 2015.

“One of the most common complaints from the nurses was that a lot of their patients had hypoglycemia, especially in the ICU, when patients were placed on insulin infusion protocols ... Every time, the nurse would have to call the attending and ask what to do,” he explains.

In addition, Dr. Zilbermint says, there was no standard for treating hypoglycemia. A nurse in one unit would give two cups of juice, another a 50% dextrose infusion, or another, milk. Even more concerning, “the nurses were so afraid of hypoglycemia they would reflexively discontinue all insulin, including basal.”

So one of the new initiatives, led by Carter Shelton, MSHCM, an administrative fellow at the Medical University of South Carolina, Charleston, was to implement a set of hospital-wide hypoglycemia prevention measures, as described in an article published online April 21 in the Journal of Diabetes Science and Technology.
 

Inpatient hypoglycemia rate was cut nearly in half

This began in 2016, when the multidisciplinary Suburban Hospital Glucose Steering Committee identified four main causes of insulin-induced hypoglycemia (defined as a blood glucose level of ≤70 mg/dL in a patient who had received at least one dose of insulin in the past 24 hours) and devised solutions for each:

1. Lack of a unified hypoglycemia protocol. A formal, evidence-based, nurse-driven treatment protocol with clinical decision support in the electronic medical record was developed. The Suburban team adapted much of the protocol from one that had been recently implemented at the flagship Johns Hopkins Hospital, in Baltimore, Maryland.

According to that protocol, if patients are able to swallow, they are given 15 g or 30 g of carbohydrates in order to achieve a blood glucose level of 50 to 70 mg/dL and <50 mg/dL, respectively. Levels are checked 15 minutes later. Intravenous D50 or glucagon is reserved for patients who can’t swallow.

2. For patients in critical care, the insulin infusion protocol that had been in use set blood glucose targets of 80 to 110 mg/dL, which resulted in hypoglycemia in nearly every patient who received an insulin infusion. This protocol was changed to the currently recommended 140 to 180 mg/dL.

3. Most patients were managed with sliding-scale insulin, an outdated yet still widely used regimen whereby insulin is given based only on current blood glucose without accounting for carbohydrates consumed with meals and not corrected until the subsequent meal. This was changed so that nurses give insulin after the patient has consumed at least 50% of their meal carbohydrates.

4. Lack of hypoglycemia reporting. A glucometrics dashboard – now used throughout the Johns Hopkins system – was adopted to produce daily hypoglycemia reports in the EMR system that could be reviewed by the inpatient glucose management service to track quality metrics and plan further interventions.

Between Jan. 1, 2016, and Sept. 30, 2019, out of a total 49,315 patient-days, there were 2,682 days on which any hypoglycemia occurred and 874 days on which moderate hypoglycemia occurred (≤54 mg/dL). Type 2 diabetes accounted for 84.4% of the total patient-days; type 1 accounted for 4.4%.

The overall frequency of any hypoglycemia patient-days per month decreased from 7.5% to 3.9% during the study period (P = .001). This was significant for the patients with type 2 diabetes (7.4% to 3.8%; P < .0001) but not for those with type 1 diabetes (18.5% to 18.0%; P = .08).

Rates of moderate hypoglycemia also decreased significantly among the patients with type 2 diabetes (1.9% to 1.0%; P = .03) but not for those with type 1 diabetes (7.4% to 6.0%; P = .14).

On the basis of these rates in reducing hypoglycemia, in which the inpatient hypoglycemia rate was cut nearly in half, the estimated savings in cost of care to the hospital was $98,635 during the period of January 2016 to September 2019.
 

Reducing insulin pen waste by minimizing duplicate prescriptions

Suburban Hospital had been using insulin vials and syringes when Dr. Zilbermint first arrived there. He lobbied the administration to allow use of pens, because they’re easier to use and they reduce the risk for needlestick injuries. Nurses were educated and retrained monthly in their use.

The switch to pens – aspart (Novolog Flexpen) for bolus insulin and glargine (Lantus SoloSTAR) – took place in 2018. The cost of the aspart pen was $16.19, and the cost of glargine was $25.08. Each holds 300 units of insulin.

After the first month, the team noticed a large increase in expenses. A quality improvement project was devised to address the issue.

“We were dispensing sometimes three or four pens per person. That’s a lot. Each pen holds 300 units, so one pen should last the entire hospital stay of an average 4- or 5-day stay,” Dr. Zilbermint explained. “We had to figure out where we were bleeding the money and where the pens were going.”

When pens disappeared, the pharmacy would have to dispense new ones. One problem was that when patients were transferred from one unit to another, the pen would be left behind and the room would be cleaned. Sometimes the pens weren’t stored properly or were misplaced. Often, they’d end up in a nurse’s pocket.

The second intervention was led by Urooj Najmi, MD, of the American International School of Medicine, Atlanta, Georgia. A program was instituted to reduce duplicate inpatient insulin pen dispensing, as detailed in an article published in the same issue of the Journal of Diabetes Science and Technology.

Solutions to reduce duplicate pen dispensing included having pharmacy track daily insulin pen reports and monitor duplicate orders, with “do not dispense” instructions conveyed via the EMR system. All multidose medications, including insulin pens, were to be placed in patients’ bins at the nursing station, and nurses were instructed to look for patients’ insulin pens prior to their being transferred to another unit, rather than ask for a replacement pen.

From July 2018 to July 2019, 3,121 patients received insulin, of whom 95% received aspart and 47% received glargine. Of the 9,516 pens dispensed, 68% were for aspart and 32% were for glargine. During the study period, the number of pens dispensed per patient dropped from 2.2 to 1.2 for aspart and from 2.1 to 1.3 for glargine; differences were highly significant (P = .0002 and P = .0005, respectively).

The total amount of unnecessary dispensing during the first 4 months after initiating the pen implementation program was 58%. The average monthly cost was $11,820.68; the projected cost per year was $141,848.

Six months after the waste reduction strategies were implemented, monthly waste had dropped to 42%, translating to an estimated potential cost savings of $66,261 over 12 months.

Because Suburban Hospital doesn’t have an outpatient dispensing license, there is still wastage when patients are discharged, because they can’t take their pens home with them. That remains a challenge, Dr. Zilbermint noted.

The team is working on implementing automatic A1c testing for patients admitted with hyperglycemia who either have a history of diabetes or whose blood glucose level is >140 mg/dL. Dr. Zilbermint said, “it’s in the guidelines, but it’s not always done.”

Dr. Zilbermint is a consultant for Guidepoint. Dr. Maynard, Mr. Shelton, and Dr. Najmi have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The selective interleukin-6 (IL-6) trans-signaling inhibitor olamkicept was well tolerated and induced clinical remissions in 3 of 16 adults with moderately to severely active inflammatory bowel disease (IBD), and remission was associated with clear alterations in levels of phospho-STAT3 (pSTAT3) in the intestinal mucosa, researchers reported.

In a 12-week, open-label, prospective phase 2a trial, patients received up to seven infusions of 600-mg olamkicept (sgp130Fc) every 2 weeks. Clinical remissions occurred in two of nine patients with ulcerative colitis and one of seven patients with Crohn’s disease. The overall rate of clinical response was 44%, which included five patients with ulcerative colitis and two patients with Crohn’s disease. Transcriptome isolation and high-throughput RNA sequencing of mucosal tissue specimens showed that clinical remitters had a decrease from baseline to week 14 in the expression of TNF, IL-1A, REG1A, IL-8, IL-1B, and LILRA, a known composite molecular surrogate for mucosal inflammation. In addition, exposing whole-blood samples to a recombinant IL-6/IL-6R fusion protein mimicked physiologic IL-6 activity and demonstrated that pSTAT3 levels dropped within 4 hours of the first olamkicept infusion and throughout treatment. “Our overall finding of decreased pSTAT3-positive cells in remission patients indicates that STAT3 is crucially involved in the mechanism of action of olamkicept,” wrote Stefan Schreiber, MD, of University Medical Center Schleswig-Holstein, Campus Kiel (Germany) together with his associates. The study is published in Gastroenterology.

Blocking the IL-6/ILR receptor can induce IBD remissions but causes “profound immunosuppression,” the investigators noted. Building on prior findings that chronic proinflammatory IL-6 activity is primarily mediated by trans-signaling of a complex of IL-6 and soluble IL6R that engages the gp130 receptor, the researchers developed a “decoy protein,” sgp130Fc (now known as olamkicept), which “exclusively blocks” IL-6 proinflammatory trans-signaling. This decoy protein showed promise in preclinical studies, with no evidence of immunosuppression, they wrote. To further evaluate olamkicept, they recruited adults with moderately to severely active ulcerative colitis or Crohn’s disease from two centers in Germany. The primary clinical assessment was remission, defined as a Mayo score under 2, with a bleeding score of 0 and an endoscopy score of less than 1 for patients with ulcerative colitis, and a Crohn’s Disease Activity Index (CDAI) of less than 150 for patients with Crohn’s disease. The primary molecular outcome was change in the composite molecular surrogate score.

Of the 16 patients, 10 completed the trial. At week 14, endoscopic responses were observed in six patients, all of whom also had a clinical response, and all three patients with clinical remissions also had endoscopic remissions. “The drug was well tolerated in all 16 treated individuals, similar to the results of the [two prior] phase 1 trials,” the researchers wrote. Although significant immunosuppression and intestinal perforations were not seen, 13 patients developed adverse events, most commonly seasonal upper respiratory tract infections, recurrence of herpes labialis, and eczema or erythema. There were five serious adverse events, two of which were cardiac in nature. A larger placebo-controlled trial is underway to further evaluate safety. For now, the researchers wrote, it appears that IL-6 trans-signaling inhibition “might open up novel therapeutic avenues for the treatment of IBD.”

University Hospital Schleswig-Holstein sponsored the study. Ferring AG provided funding and donated the olamkicept. Analyses were funded by EU H2020 SYSCID and EU H2020 Innovative Medicines Initiative 2 Joint Undertaking. Dr. Schreiber reported having coinvented IP and having ties to Pfizer, Bristol Myers Squibb, and Roche. Four coinvestigators disclosed ties to Ferring, AbbVie, Chugai, Roche, Regeneron, Pfizer, Sanofi, Conaris, and Genentech Roche. The other researchers reported having no conflicts of interest.

The selective interleukin-6 (IL-6) trans-signaling inhibitor olamkicept was well tolerated and induced clinical remissions in 3 of 16 adults with moderately to severely active inflammatory bowel disease (IBD), and remission was associated with clear alterations in levels of phospho-STAT3 (pSTAT3) in the intestinal mucosa, researchers reported.

In a 12-week, open-label, prospective phase 2a trial, patients received up to seven infusions of 600-mg olamkicept (sgp130Fc) every 2 weeks. Clinical remissions occurred in two of nine patients with ulcerative colitis and one of seven patients with Crohn’s disease. The overall rate of clinical response was 44%, which included five patients with ulcerative colitis and two patients with Crohn’s disease. Transcriptome isolation and high-throughput RNA sequencing of mucosal tissue specimens showed that clinical remitters had a decrease from baseline to week 14 in the expression of TNF, IL-1A, REG1A, IL-8, IL-1B, and LILRA, a known composite molecular surrogate for mucosal inflammation. In addition, exposing whole-blood samples to a recombinant IL-6/IL-6R fusion protein mimicked physiologic IL-6 activity and demonstrated that pSTAT3 levels dropped within 4 hours of the first olamkicept infusion and throughout treatment. “Our overall finding of decreased pSTAT3-positive cells in remission patients indicates that STAT3 is crucially involved in the mechanism of action of olamkicept,” wrote Stefan Schreiber, MD, of University Medical Center Schleswig-Holstein, Campus Kiel (Germany) together with his associates. The study is published in Gastroenterology.

Blocking the IL-6/ILR receptor can induce IBD remissions but causes “profound immunosuppression,” the investigators noted. Building on prior findings that chronic proinflammatory IL-6 activity is primarily mediated by trans-signaling of a complex of IL-6 and soluble IL6R that engages the gp130 receptor, the researchers developed a “decoy protein,” sgp130Fc (now known as olamkicept), which “exclusively blocks” IL-6 proinflammatory trans-signaling. This decoy protein showed promise in preclinical studies, with no evidence of immunosuppression, they wrote. To further evaluate olamkicept, they recruited adults with moderately to severely active ulcerative colitis or Crohn’s disease from two centers in Germany. The primary clinical assessment was remission, defined as a Mayo score under 2, with a bleeding score of 0 and an endoscopy score of less than 1 for patients with ulcerative colitis, and a Crohn’s Disease Activity Index (CDAI) of less than 150 for patients with Crohn’s disease. The primary molecular outcome was change in the composite molecular surrogate score.

Of the 16 patients, 10 completed the trial. At week 14, endoscopic responses were observed in six patients, all of whom also had a clinical response, and all three patients with clinical remissions also had endoscopic remissions. “The drug was well tolerated in all 16 treated individuals, similar to the results of the [two prior] phase 1 trials,” the researchers wrote. Although significant immunosuppression and intestinal perforations were not seen, 13 patients developed adverse events, most commonly seasonal upper respiratory tract infections, recurrence of herpes labialis, and eczema or erythema. There were five serious adverse events, two of which were cardiac in nature. A larger placebo-controlled trial is underway to further evaluate safety. For now, the researchers wrote, it appears that IL-6 trans-signaling inhibition “might open up novel therapeutic avenues for the treatment of IBD.”

University Hospital Schleswig-Holstein sponsored the study. Ferring AG provided funding and donated the olamkicept. Analyses were funded by EU H2020 SYSCID and EU H2020 Innovative Medicines Initiative 2 Joint Undertaking. Dr. Schreiber reported having coinvented IP and having ties to Pfizer, Bristol Myers Squibb, and Roche. Four coinvestigators disclosed ties to Ferring, AbbVie, Chugai, Roche, Regeneron, Pfizer, Sanofi, Conaris, and Genentech Roche. The other researchers reported having no conflicts of interest.

The selective interleukin-6 (IL-6) trans-signaling inhibitor olamkicept was well tolerated and induced clinical remissions in 3 of 16 adults with moderately to severely active inflammatory bowel disease (IBD), and remission was associated with clear alterations in levels of phospho-STAT3 (pSTAT3) in the intestinal mucosa, researchers reported.

In a 12-week, open-label, prospective phase 2a trial, patients received up to seven infusions of 600-mg olamkicept (sgp130Fc) every 2 weeks. Clinical remissions occurred in two of nine patients with ulcerative colitis and one of seven patients with Crohn’s disease. The overall rate of clinical response was 44%, which included five patients with ulcerative colitis and two patients with Crohn’s disease. Transcriptome isolation and high-throughput RNA sequencing of mucosal tissue specimens showed that clinical remitters had a decrease from baseline to week 14 in the expression of TNF, IL-1A, REG1A, IL-8, IL-1B, and LILRA, a known composite molecular surrogate for mucosal inflammation. In addition, exposing whole-blood samples to a recombinant IL-6/IL-6R fusion protein mimicked physiologic IL-6 activity and demonstrated that pSTAT3 levels dropped within 4 hours of the first olamkicept infusion and throughout treatment. “Our overall finding of decreased pSTAT3-positive cells in remission patients indicates that STAT3 is crucially involved in the mechanism of action of olamkicept,” wrote Stefan Schreiber, MD, of University Medical Center Schleswig-Holstein, Campus Kiel (Germany) together with his associates. The study is published in Gastroenterology.

Blocking the IL-6/ILR receptor can induce IBD remissions but causes “profound immunosuppression,” the investigators noted. Building on prior findings that chronic proinflammatory IL-6 activity is primarily mediated by trans-signaling of a complex of IL-6 and soluble IL6R that engages the gp130 receptor, the researchers developed a “decoy protein,” sgp130Fc (now known as olamkicept), which “exclusively blocks” IL-6 proinflammatory trans-signaling. This decoy protein showed promise in preclinical studies, with no evidence of immunosuppression, they wrote. To further evaluate olamkicept, they recruited adults with moderately to severely active ulcerative colitis or Crohn’s disease from two centers in Germany. The primary clinical assessment was remission, defined as a Mayo score under 2, with a bleeding score of 0 and an endoscopy score of less than 1 for patients with ulcerative colitis, and a Crohn’s Disease Activity Index (CDAI) of less than 150 for patients with Crohn’s disease. The primary molecular outcome was change in the composite molecular surrogate score.

Of the 16 patients, 10 completed the trial. At week 14, endoscopic responses were observed in six patients, all of whom also had a clinical response, and all three patients with clinical remissions also had endoscopic remissions. “The drug was well tolerated in all 16 treated individuals, similar to the results of the [two prior] phase 1 trials,” the researchers wrote. Although significant immunosuppression and intestinal perforations were not seen, 13 patients developed adverse events, most commonly seasonal upper respiratory tract infections, recurrence of herpes labialis, and eczema or erythema. There were five serious adverse events, two of which were cardiac in nature. A larger placebo-controlled trial is underway to further evaluate safety. For now, the researchers wrote, it appears that IL-6 trans-signaling inhibition “might open up novel therapeutic avenues for the treatment of IBD.”

University Hospital Schleswig-Holstein sponsored the study. Ferring AG provided funding and donated the olamkicept. Analyses were funded by EU H2020 SYSCID and EU H2020 Innovative Medicines Initiative 2 Joint Undertaking. Dr. Schreiber reported having coinvented IP and having ties to Pfizer, Bristol Myers Squibb, and Roche. Four coinvestigators disclosed ties to Ferring, AbbVie, Chugai, Roche, Regeneron, Pfizer, Sanofi, Conaris, and Genentech Roche. The other researchers reported having no conflicts of interest.

Two different agents showed potential for safely treating patients with hypothalamic obesity in two pilot studies with small numbers of patients.

One study prospectively randomized 21 adults with acquired hypothalamic obesity to treatment with placebo or Tesomet, a compound that combines the novel monoamine reuptake inhibitor tesofensine with metoprolol, a beta-blocker added to protect against adverse effects from tesofensine on heart rate and cardiac contractility. After 24 weeks of treatment, people on tesofensine/metoprolol had significant weight loss, compared with controls, while showing good tolerance with no significant effects on heart rate, blood pressure, or heart rhythm, Ulla Feldt-Rasmussen, MD, DMSc, reported at the annual meeting of the Endocrine Society.

The second report reviewed 18 children and adolescents with either acquired or genetic hypothalamic obesity who received open-label treatment with dextroamphetamine for an average of 20 months, and overall patients safely lost an average of 0.43 in their body mass index (BMI) standard deviation score, reported Jiska van Schaik, MD, in a separate talk at the meeting.



‘A supplement for lost satiety’

Patients with hypothalamic obesity face a dual problem from hypothalamic dysfunction that’s addressed by tesofensine, the weight-loss agent in Tesomet that increases hypothalamic levels of dopamine, serotonin, and noradrenaline by blocking reuptake, and thereby dulls appetite and food craving while also increasing fat metabolism, explained Dr. Feldt-Rasmussen, a professor of medical endocrinology at the University of Denmark and Rigshospitalet in Copenhagen. No treatment currently has regulatory approval for treating any form of hypothalamic obesity.

Tesofensine works as “a supplement for lost satiety, and satiety is what is lost” in patients with hypothalamic obesity as well in patients as Prader-Willi syndrome, the two disorders for which tesofensine/metoprolol is currently undergoing testing. “That’s the rationale, and it seems to work,” she declared during her talk. The formulation contains 0.5 mg tesofensine and 50 mg metoprolol administered orally once daily.

The study, run at Rigshospitalet, randomized 21 patients aged 18-75 years and with a BMI of at least 27 kg/m²who all had acquired hypothalamic obesity secondary to hypothalamic damage following cancer treatment. Patients averaged about 45 years of age, three-quarters were women, and their average BMI was about 37^, with 90% having a BMI of at least 30.

The study’s design calls for 48-week follow-up; Dr. Feldt-Rasmussen presented the interim results after 24 weeks, with 18 of the 21 enrolled patients remaining in the study through 24 weeks. Three patients dropped out because of adverse events: one in the placebo arm, and two who received tesofensine/metoprolol.

Weight dropped by an average of 6.6 kg from baseline among the 11 patients who completed 24 weeks on tesofensine/metoprolol treatment, compared with no average change from baseline among the seven patients who completed the study on placebo, a significant difference. The researchers measured a validated, composite satiety score every 4 weeks, and found significantly more improvement among patients on tesofensine/metoprolol than in those on placebo during the study’s first half, but subsequently average scores among the actively treated patients fell to the same level of modest improvement as in the placebo patients.

Despite this, average weight loss in the patients on tesofensine/metoprolol steadily increased throughout the full 24 weeks.

Safety measures of diastolic blood pressure, heart rate, and corrected QT interval showed no significant between-group difference. Systolic pressure showed a transient average rise of 4 mm Hg above baseline in the tesofensine/metoprolol group, compared with a small dip in the control patients, but by 24 weeks average systolic blood pressure had reverted closer to baseline levels in both subgroups and showed no significant between-group difference. Two patients on tesofensine/metoprolol developed serious adverse events. In one patient these were not treatment related. The other patient developed anxiety after 8 weeks that was possibly treatment related but remained on treatment. Other adverse effects on tesofensine/metoprolol included dizziness, sleep disorder, and dry mouth, but all of these were mild and patients were willing to tolerate them to achieve their weight loss, Dr. Feldt-Rasmussen said.



Repurposing an ADHD treatment

Dextroamphetamine increases satiety and boosts resting energy expenditure, and is a common treatment for attention deficit hyperactivity disorder. Dr. van Schaik and coauthors reviewed 13 children and adolescents with acquired hypothalamic obesity and 5 with genetic hypothalamic obesity who received the treatment at either of two Dutch hospitals during 2014-2020. All 18 patients went on dextroamphetamine after other interventions had failed to produce improvement, said Dr. van Schaik, a researcher at University Medical Center and Wilhelmina Children’s Hospital in Utrecht, the Netherlands. The patients averaged about 13 years of age.

In addition to an overall effect on weight across all 18 subjects, the researchers found they could subdivide the full cohort into 10 responders (56%), 4 (22%) with weight stabilization on treatment, and 4 nonresponders (22%) who continued to gain weight despite treatment. The 10 responding patients had an average drop in their BMI standard deviation score of 0.91. All 10 responders had acquired hypothalamic obesity, and they averaged a 12.5 percentage point rise in their resting energy expenditure level, compared with baseline, while on treatment. The four whose weight stabilized on treatment included three patients with genetic hypothalamic obesity. The four nonresponders split into two with acquired hypothalamic obesity and two with the genetic form.

Thirteen patients (72%) had improvements in hyperphagia, energy, and behavior, and no patient had a serious adverse effect. One patient stopped treatment after 1 month because of elevated blood pressure.

“Dextroamphetamine may be promising, especially for acquired hypothalamic obesity,” Dr. van Schaik concluded, adding that prospective, controlled assessments are needed, and that a healthy lifestyle is the foundation of hypothalamic obesity treatment.

The Tesomet study was sponsored by Saniona, the company developing Tesomet. Dr Feldt-Rasmussen is an advisor to Saniona, and some of the coauthors on the study are Saniona employees. Dr. van Schaik had no disclosures.

[email protected]

Two different agents showed potential for safely treating patients with hypothalamic obesity in two pilot studies with small numbers of patients.

One study prospectively randomized 21 adults with acquired hypothalamic obesity to treatment with placebo or Tesomet, a compound that combines the novel monoamine reuptake inhibitor tesofensine with metoprolol, a beta-blocker added to protect against adverse effects from tesofensine on heart rate and cardiac contractility. After 24 weeks of treatment, people on tesofensine/metoprolol had significant weight loss, compared with controls, while showing good tolerance with no significant effects on heart rate, blood pressure, or heart rhythm, Ulla Feldt-Rasmussen, MD, DMSc, reported at the annual meeting of the Endocrine Society.

The second report reviewed 18 children and adolescents with either acquired or genetic hypothalamic obesity who received open-label treatment with dextroamphetamine for an average of 20 months, and overall patients safely lost an average of 0.43 in their body mass index (BMI) standard deviation score, reported Jiska van Schaik, MD, in a separate talk at the meeting.



‘A supplement for lost satiety’

Patients with hypothalamic obesity face a dual problem from hypothalamic dysfunction that’s addressed by tesofensine, the weight-loss agent in Tesomet that increases hypothalamic levels of dopamine, serotonin, and noradrenaline by blocking reuptake, and thereby dulls appetite and food craving while also increasing fat metabolism, explained Dr. Feldt-Rasmussen, a professor of medical endocrinology at the University of Denmark and Rigshospitalet in Copenhagen. No treatment currently has regulatory approval for treating any form of hypothalamic obesity.

Tesofensine works as “a supplement for lost satiety, and satiety is what is lost” in patients with hypothalamic obesity as well in patients as Prader-Willi syndrome, the two disorders for which tesofensine/metoprolol is currently undergoing testing. “That’s the rationale, and it seems to work,” she declared during her talk. The formulation contains 0.5 mg tesofensine and 50 mg metoprolol administered orally once daily.

The study, run at Rigshospitalet, randomized 21 patients aged 18-75 years and with a BMI of at least 27 kg/m²who all had acquired hypothalamic obesity secondary to hypothalamic damage following cancer treatment. Patients averaged about 45 years of age, three-quarters were women, and their average BMI was about 37^, with 90% having a BMI of at least 30.

The study’s design calls for 48-week follow-up; Dr. Feldt-Rasmussen presented the interim results after 24 weeks, with 18 of the 21 enrolled patients remaining in the study through 24 weeks. Three patients dropped out because of adverse events: one in the placebo arm, and two who received tesofensine/metoprolol.

Weight dropped by an average of 6.6 kg from baseline among the 11 patients who completed 24 weeks on tesofensine/metoprolol treatment, compared with no average change from baseline among the seven patients who completed the study on placebo, a significant difference. The researchers measured a validated, composite satiety score every 4 weeks, and found significantly more improvement among patients on tesofensine/metoprolol than in those on placebo during the study’s first half, but subsequently average scores among the actively treated patients fell to the same level of modest improvement as in the placebo patients.

Despite this, average weight loss in the patients on tesofensine/metoprolol steadily increased throughout the full 24 weeks.

Safety measures of diastolic blood pressure, heart rate, and corrected QT interval showed no significant between-group difference. Systolic pressure showed a transient average rise of 4 mm Hg above baseline in the tesofensine/metoprolol group, compared with a small dip in the control patients, but by 24 weeks average systolic blood pressure had reverted closer to baseline levels in both subgroups and showed no significant between-group difference. Two patients on tesofensine/metoprolol developed serious adverse events. In one patient these were not treatment related. The other patient developed anxiety after 8 weeks that was possibly treatment related but remained on treatment. Other adverse effects on tesofensine/metoprolol included dizziness, sleep disorder, and dry mouth, but all of these were mild and patients were willing to tolerate them to achieve their weight loss, Dr. Feldt-Rasmussen said.



Repurposing an ADHD treatment

Dextroamphetamine increases satiety and boosts resting energy expenditure, and is a common treatment for attention deficit hyperactivity disorder. Dr. van Schaik and coauthors reviewed 13 children and adolescents with acquired hypothalamic obesity and 5 with genetic hypothalamic obesity who received the treatment at either of two Dutch hospitals during 2014-2020. All 18 patients went on dextroamphetamine after other interventions had failed to produce improvement, said Dr. van Schaik, a researcher at University Medical Center and Wilhelmina Children’s Hospital in Utrecht, the Netherlands. The patients averaged about 13 years of age.

In addition to an overall effect on weight across all 18 subjects, the researchers found they could subdivide the full cohort into 10 responders (56%), 4 (22%) with weight stabilization on treatment, and 4 nonresponders (22%) who continued to gain weight despite treatment. The 10 responding patients had an average drop in their BMI standard deviation score of 0.91. All 10 responders had acquired hypothalamic obesity, and they averaged a 12.5 percentage point rise in their resting energy expenditure level, compared with baseline, while on treatment. The four whose weight stabilized on treatment included three patients with genetic hypothalamic obesity. The four nonresponders split into two with acquired hypothalamic obesity and two with the genetic form.

Thirteen patients (72%) had improvements in hyperphagia, energy, and behavior, and no patient had a serious adverse effect. One patient stopped treatment after 1 month because of elevated blood pressure.

“Dextroamphetamine may be promising, especially for acquired hypothalamic obesity,” Dr. van Schaik concluded, adding that prospective, controlled assessments are needed, and that a healthy lifestyle is the foundation of hypothalamic obesity treatment.

The Tesomet study was sponsored by Saniona, the company developing Tesomet. Dr Feldt-Rasmussen is an advisor to Saniona, and some of the coauthors on the study are Saniona employees. Dr. van Schaik had no disclosures.

[email protected]

Two different agents showed potential for safely treating patients with hypothalamic obesity in two pilot studies with small numbers of patients.

One study prospectively randomized 21 adults with acquired hypothalamic obesity to treatment with placebo or Tesomet, a compound that combines the novel monoamine reuptake inhibitor tesofensine with metoprolol, a beta-blocker added to protect against adverse effects from tesofensine on heart rate and cardiac contractility. After 24 weeks of treatment, people on tesofensine/metoprolol had significant weight loss, compared with controls, while showing good tolerance with no significant effects on heart rate, blood pressure, or heart rhythm, Ulla Feldt-Rasmussen, MD, DMSc, reported at the annual meeting of the Endocrine Society.

The second report reviewed 18 children and adolescents with either acquired or genetic hypothalamic obesity who received open-label treatment with dextroamphetamine for an average of 20 months, and overall patients safely lost an average of 0.43 in their body mass index (BMI) standard deviation score, reported Jiska van Schaik, MD, in a separate talk at the meeting.



‘A supplement for lost satiety’

Patients with hypothalamic obesity face a dual problem from hypothalamic dysfunction that’s addressed by tesofensine, the weight-loss agent in Tesomet that increases hypothalamic levels of dopamine, serotonin, and noradrenaline by blocking reuptake, and thereby dulls appetite and food craving while also increasing fat metabolism, explained Dr. Feldt-Rasmussen, a professor of medical endocrinology at the University of Denmark and Rigshospitalet in Copenhagen. No treatment currently has regulatory approval for treating any form of hypothalamic obesity.

Tesofensine works as “a supplement for lost satiety, and satiety is what is lost” in patients with hypothalamic obesity as well in patients as Prader-Willi syndrome, the two disorders for which tesofensine/metoprolol is currently undergoing testing. “That’s the rationale, and it seems to work,” she declared during her talk. The formulation contains 0.5 mg tesofensine and 50 mg metoprolol administered orally once daily.

The study, run at Rigshospitalet, randomized 21 patients aged 18-75 years and with a BMI of at least 27 kg/m²who all had acquired hypothalamic obesity secondary to hypothalamic damage following cancer treatment. Patients averaged about 45 years of age, three-quarters were women, and their average BMI was about 37^, with 90% having a BMI of at least 30.

The study’s design calls for 48-week follow-up; Dr. Feldt-Rasmussen presented the interim results after 24 weeks, with 18 of the 21 enrolled patients remaining in the study through 24 weeks. Three patients dropped out because of adverse events: one in the placebo arm, and two who received tesofensine/metoprolol.

Weight dropped by an average of 6.6 kg from baseline among the 11 patients who completed 24 weeks on tesofensine/metoprolol treatment, compared with no average change from baseline among the seven patients who completed the study on placebo, a significant difference. The researchers measured a validated, composite satiety score every 4 weeks, and found significantly more improvement among patients on tesofensine/metoprolol than in those on placebo during the study’s first half, but subsequently average scores among the actively treated patients fell to the same level of modest improvement as in the placebo patients.

Despite this, average weight loss in the patients on tesofensine/metoprolol steadily increased throughout the full 24 weeks.

Safety measures of diastolic blood pressure, heart rate, and corrected QT interval showed no significant between-group difference. Systolic pressure showed a transient average rise of 4 mm Hg above baseline in the tesofensine/metoprolol group, compared with a small dip in the control patients, but by 24 weeks average systolic blood pressure had reverted closer to baseline levels in both subgroups and showed no significant between-group difference. Two patients on tesofensine/metoprolol developed serious adverse events. In one patient these were not treatment related. The other patient developed anxiety after 8 weeks that was possibly treatment related but remained on treatment. Other adverse effects on tesofensine/metoprolol included dizziness, sleep disorder, and dry mouth, but all of these were mild and patients were willing to tolerate them to achieve their weight loss, Dr. Feldt-Rasmussen said.



Repurposing an ADHD treatment

Dextroamphetamine increases satiety and boosts resting energy expenditure, and is a common treatment for attention deficit hyperactivity disorder. Dr. van Schaik and coauthors reviewed 13 children and adolescents with acquired hypothalamic obesity and 5 with genetic hypothalamic obesity who received the treatment at either of two Dutch hospitals during 2014-2020. All 18 patients went on dextroamphetamine after other interventions had failed to produce improvement, said Dr. van Schaik, a researcher at University Medical Center and Wilhelmina Children’s Hospital in Utrecht, the Netherlands. The patients averaged about 13 years of age.

In addition to an overall effect on weight across all 18 subjects, the researchers found they could subdivide the full cohort into 10 responders (56%), 4 (22%) with weight stabilization on treatment, and 4 nonresponders (22%) who continued to gain weight despite treatment. The 10 responding patients had an average drop in their BMI standard deviation score of 0.91. All 10 responders had acquired hypothalamic obesity, and they averaged a 12.5 percentage point rise in their resting energy expenditure level, compared with baseline, while on treatment. The four whose weight stabilized on treatment included three patients with genetic hypothalamic obesity. The four nonresponders split into two with acquired hypothalamic obesity and two with the genetic form.

Thirteen patients (72%) had improvements in hyperphagia, energy, and behavior, and no patient had a serious adverse effect. One patient stopped treatment after 1 month because of elevated blood pressure.

“Dextroamphetamine may be promising, especially for acquired hypothalamic obesity,” Dr. van Schaik concluded, adding that prospective, controlled assessments are needed, and that a healthy lifestyle is the foundation of hypothalamic obesity treatment.

The Tesomet study was sponsored by Saniona, the company developing Tesomet. Dr Feldt-Rasmussen is an advisor to Saniona, and some of the coauthors on the study are Saniona employees. Dr. van Schaik had no disclosures.

[email protected]

The past year presented unprecedented challenges for many. In addition, mental health services have also been stretched to capacity. Anecdotally, some hospitals and emergency departments note that more youth have been presenting in mental health crises, and the severity of symptoms has also been higher. Safety planning is important, including working with patients to identify skills they can use in distress. Even those who do not experience suicidal thoughts may struggle with dysregulation or may use coping strategies that may not be the healthiest in the long term.

Within my practice, I see some families who are still waiting for an available therapist, or some may not wish to participate in therapy despite its being recommended. For these families, supporting them in using strategies that they may be willing and able to use in the moment to help them get through the moment of crisis can been helpful:
 

Case example (identifying details have been changed)

Emily is a 17-year-old girl who has a history of generalized anxiety disorder and obsessive-compulsive disorder. She has had multiple medication trials and a course of cognitive behavioral therapy when younger, with significant improvement in symptoms. She returns to clinic because of increased anxiety related to stressors of the pandemic. She wishes to not return to therapy because of feeling that she received maximal benefit and that further sessions would not be fruitful. However, she struggles with identifying what skills she can use, and her anxiety heightens significantly to near-panic and hyperventilating with even cursory exploration of triggers for her symptoms. Medications are also discussed during this appointment, and it is noted that it may take some time to see therapeutic effect. Of note, she reports no acute safety concerns. She has engaged in skin picking. No reported substance use. As she hyperventilates, she was asked to identify items in the room matching the colors of the rainbow in order. She was able to quickly do this, and then was asked to do it again. Afterward, she noted feeling much less anxious because it distracted her from her thoughts.

Distress tolerance skills can be very helpful to navigate getting through a crisis. When under stress, some may be more likely to engage in behaviors that are not helpful in the long term such as using avoidance; procrastinating; consuming tobacco, alcohol, or other substances; spending too much time on screens; or engaging in self-harm behaviors. While some of these activities may be okay in moderation, others are always harmful. At times, when encouraging patients to use skills with which they may be more familiar, e.g., deep breathing, progressive muscle relaxation, the response may be, “these don’t work!” It can be important to distinguish that the function of these skills is not to make someone feel good or to eliminate the stressor, but to “take some of the edge off” so they are less likely to slide into problematic behaviors. It can be beneficial to have multiple tools at one’s disposal because not all skills will always be effective or available.

TIPP skills (temperature, intense exercise, paced breathing, progressive muscle relaxation) are distress tolerance skills from dialectical behavioral therapy (DBT),¹ which was initially developed to treat individuals with borderline personality disorder. More recently, the therapy modality has been applied to individuals who may struggle with emotion regulation for a variety of reasons. TIPP skills work quickly (within seconds to minutes) with the aim to decrease physiological arousal. They do not require a lot of thinking, and many are portable or easy to use. Given the speed of effect, these skills can also be used in lieu of p.r.n. medications or patients can be counseled about trying these instead of turning to substance use. The effect is brief (5-20 minutes), although this may lower the affective temperature sufficiently for someone to get through the intense moment or to be able to then utilize other skills that may require more cognitive reserves.
 

T – Temperature

Holding one’s breath and placing one’s face in cold water (above 50°) for 10-20 seconds to stimulate the diving response and decrease heart rate. Patients can repeat this up to 3 times. Alternatively, cold compresses or gel eye masks can be used.

I – Intense exercise

Aerobic exercise for 10-20 minutes. This can include running, jumping jacks, dancing to loud music in a way that feels intense. The parasympathetic nervous system (PNS) is activated for approximately 20 minutes after cessation of intense exercise.

P – Paced breathing

Decreasing rate of breathing, with each inhalation/exhalation cycle lasting 10-12 seconds and the exhale being longer than the inhale also activates the PNS.

P – Progressive muscle relaxation (PMR)

Sequentially tensing and relaxing muscles from head to toes. Having at least 5-10 minutes to perform this exercise is preferred.² Children’s Hospital of Philadelphia offerssample PMR recordings.

Body scans can also be helpful. This practice differs from PMR in that it is a mindfulness practice noting body sensations without trying to change them. The University of Vermont offers some sample exercises.³

These skills were described to Emily. She noted that dunking her face in cold water was effective and it was reassuring knowing she had a tool to help her anxiety. She started to push herself to go outside to exercise. We additionally incorporated other distraction techniques such as identifying items from colors of the rainbow that were around her. She appreciated that she could even do this discreetly while at school. At times she had to do a couple of rounds, but this could help stop her repetitive thoughts so she could use other skills.

Helping patients identify skills that can help in the moment can help them feel supported and gain traction in other areas.
 

Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. She has no relevant financial disclosures

References

1. Rathus JH, Miller AL. DBT® Skills manual for adolescents. 2015. Guilford Press.

2. Guided Relaxation Exercises, Children’s Hospital of Philadelphia.

3. Vermont Center for Children, Youth, and Families: Staying Close While Keeping Your Distance.
 

The past year presented unprecedented challenges for many. In addition, mental health services have also been stretched to capacity. Anecdotally, some hospitals and emergency departments note that more youth have been presenting in mental health crises, and the severity of symptoms has also been higher. Safety planning is important, including working with patients to identify skills they can use in distress. Even those who do not experience suicidal thoughts may struggle with dysregulation or may use coping strategies that may not be the healthiest in the long term.

Within my practice, I see some families who are still waiting for an available therapist, or some may not wish to participate in therapy despite its being recommended. For these families, supporting them in using strategies that they may be willing and able to use in the moment to help them get through the moment of crisis can been helpful:
 

Case example (identifying details have been changed)

Emily is a 17-year-old girl who has a history of generalized anxiety disorder and obsessive-compulsive disorder. She has had multiple medication trials and a course of cognitive behavioral therapy when younger, with significant improvement in symptoms. She returns to clinic because of increased anxiety related to stressors of the pandemic. She wishes to not return to therapy because of feeling that she received maximal benefit and that further sessions would not be fruitful. However, she struggles with identifying what skills she can use, and her anxiety heightens significantly to near-panic and hyperventilating with even cursory exploration of triggers for her symptoms. Medications are also discussed during this appointment, and it is noted that it may take some time to see therapeutic effect. Of note, she reports no acute safety concerns. She has engaged in skin picking. No reported substance use. As she hyperventilates, she was asked to identify items in the room matching the colors of the rainbow in order. She was able to quickly do this, and then was asked to do it again. Afterward, she noted feeling much less anxious because it distracted her from her thoughts.

Distress tolerance skills can be very helpful to navigate getting through a crisis. When under stress, some may be more likely to engage in behaviors that are not helpful in the long term such as using avoidance; procrastinating; consuming tobacco, alcohol, or other substances; spending too much time on screens; or engaging in self-harm behaviors. While some of these activities may be okay in moderation, others are always harmful. At times, when encouraging patients to use skills with which they may be more familiar, e.g., deep breathing, progressive muscle relaxation, the response may be, “these don’t work!” It can be important to distinguish that the function of these skills is not to make someone feel good or to eliminate the stressor, but to “take some of the edge off” so they are less likely to slide into problematic behaviors. It can be beneficial to have multiple tools at one’s disposal because not all skills will always be effective or available.

TIPP skills (temperature, intense exercise, paced breathing, progressive muscle relaxation) are distress tolerance skills from dialectical behavioral therapy (DBT),¹ which was initially developed to treat individuals with borderline personality disorder. More recently, the therapy modality has been applied to individuals who may struggle with emotion regulation for a variety of reasons. TIPP skills work quickly (within seconds to minutes) with the aim to decrease physiological arousal. They do not require a lot of thinking, and many are portable or easy to use. Given the speed of effect, these skills can also be used in lieu of p.r.n. medications or patients can be counseled about trying these instead of turning to substance use. The effect is brief (5-20 minutes), although this may lower the affective temperature sufficiently for someone to get through the intense moment or to be able to then utilize other skills that may require more cognitive reserves.
 

T – Temperature

Holding one’s breath and placing one’s face in cold water (above 50°) for 10-20 seconds to stimulate the diving response and decrease heart rate. Patients can repeat this up to 3 times. Alternatively, cold compresses or gel eye masks can be used.

I – Intense exercise

Aerobic exercise for 10-20 minutes. This can include running, jumping jacks, dancing to loud music in a way that feels intense. The parasympathetic nervous system (PNS) is activated for approximately 20 minutes after cessation of intense exercise.

P – Paced breathing

Decreasing rate of breathing, with each inhalation/exhalation cycle lasting 10-12 seconds and the exhale being longer than the inhale also activates the PNS.

P – Progressive muscle relaxation (PMR)

Sequentially tensing and relaxing muscles from head to toes. Having at least 5-10 minutes to perform this exercise is preferred.² Children’s Hospital of Philadelphia offerssample PMR recordings.

Body scans can also be helpful. This practice differs from PMR in that it is a mindfulness practice noting body sensations without trying to change them. The University of Vermont offers some sample exercises.³

These skills were described to Emily. She noted that dunking her face in cold water was effective and it was reassuring knowing she had a tool to help her anxiety. She started to push herself to go outside to exercise. We additionally incorporated other distraction techniques such as identifying items from colors of the rainbow that were around her. She appreciated that she could even do this discreetly while at school. At times she had to do a couple of rounds, but this could help stop her repetitive thoughts so she could use other skills.

Helping patients identify skills that can help in the moment can help them feel supported and gain traction in other areas.
 

Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. She has no relevant financial disclosures

References

1. Rathus JH, Miller AL. DBT® Skills manual for adolescents. 2015. Guilford Press.

2. Guided Relaxation Exercises, Children’s Hospital of Philadelphia.

3. Vermont Center for Children, Youth, and Families: Staying Close While Keeping Your Distance.
 

The past year presented unprecedented challenges for many. In addition, mental health services have also been stretched to capacity. Anecdotally, some hospitals and emergency departments note that more youth have been presenting in mental health crises, and the severity of symptoms has also been higher. Safety planning is important, including working with patients to identify skills they can use in distress. Even those who do not experience suicidal thoughts may struggle with dysregulation or may use coping strategies that may not be the healthiest in the long term.

Within my practice, I see some families who are still waiting for an available therapist, or some may not wish to participate in therapy despite its being recommended. For these families, supporting them in using strategies that they may be willing and able to use in the moment to help them get through the moment of crisis can been helpful:
 

Case example (identifying details have been changed)

Emily is a 17-year-old girl who has a history of generalized anxiety disorder and obsessive-compulsive disorder. She has had multiple medication trials and a course of cognitive behavioral therapy when younger, with significant improvement in symptoms. She returns to clinic because of increased anxiety related to stressors of the pandemic. She wishes to not return to therapy because of feeling that she received maximal benefit and that further sessions would not be fruitful. However, she struggles with identifying what skills she can use, and her anxiety heightens significantly to near-panic and hyperventilating with even cursory exploration of triggers for her symptoms. Medications are also discussed during this appointment, and it is noted that it may take some time to see therapeutic effect. Of note, she reports no acute safety concerns. She has engaged in skin picking. No reported substance use. As she hyperventilates, she was asked to identify items in the room matching the colors of the rainbow in order. She was able to quickly do this, and then was asked to do it again. Afterward, she noted feeling much less anxious because it distracted her from her thoughts.

Distress tolerance skills can be very helpful to navigate getting through a crisis. When under stress, some may be more likely to engage in behaviors that are not helpful in the long term such as using avoidance; procrastinating; consuming tobacco, alcohol, or other substances; spending too much time on screens; or engaging in self-harm behaviors. While some of these activities may be okay in moderation, others are always harmful. At times, when encouraging patients to use skills with which they may be more familiar, e.g., deep breathing, progressive muscle relaxation, the response may be, “these don’t work!” It can be important to distinguish that the function of these skills is not to make someone feel good or to eliminate the stressor, but to “take some of the edge off” so they are less likely to slide into problematic behaviors. It can be beneficial to have multiple tools at one’s disposal because not all skills will always be effective or available.

TIPP skills (temperature, intense exercise, paced breathing, progressive muscle relaxation) are distress tolerance skills from dialectical behavioral therapy (DBT),¹ which was initially developed to treat individuals with borderline personality disorder. More recently, the therapy modality has been applied to individuals who may struggle with emotion regulation for a variety of reasons. TIPP skills work quickly (within seconds to minutes) with the aim to decrease physiological arousal. They do not require a lot of thinking, and many are portable or easy to use. Given the speed of effect, these skills can also be used in lieu of p.r.n. medications or patients can be counseled about trying these instead of turning to substance use. The effect is brief (5-20 minutes), although this may lower the affective temperature sufficiently for someone to get through the intense moment or to be able to then utilize other skills that may require more cognitive reserves.
 

T – Temperature

Holding one’s breath and placing one’s face in cold water (above 50°) for 10-20 seconds to stimulate the diving response and decrease heart rate. Patients can repeat this up to 3 times. Alternatively, cold compresses or gel eye masks can be used.

I – Intense exercise

Aerobic exercise for 10-20 minutes. This can include running, jumping jacks, dancing to loud music in a way that feels intense. The parasympathetic nervous system (PNS) is activated for approximately 20 minutes after cessation of intense exercise.

P – Paced breathing

Decreasing rate of breathing, with each inhalation/exhalation cycle lasting 10-12 seconds and the exhale being longer than the inhale also activates the PNS.

P – Progressive muscle relaxation (PMR)

Sequentially tensing and relaxing muscles from head to toes. Having at least 5-10 minutes to perform this exercise is preferred.² Children’s Hospital of Philadelphia offerssample PMR recordings.

Body scans can also be helpful. This practice differs from PMR in that it is a mindfulness practice noting body sensations without trying to change them. The University of Vermont offers some sample exercises.³

These skills were described to Emily. She noted that dunking her face in cold water was effective and it was reassuring knowing she had a tool to help her anxiety. She started to push herself to go outside to exercise. We additionally incorporated other distraction techniques such as identifying items from colors of the rainbow that were around her. She appreciated that she could even do this discreetly while at school. At times she had to do a couple of rounds, but this could help stop her repetitive thoughts so she could use other skills.

Helping patients identify skills that can help in the moment can help them feel supported and gain traction in other areas.
 

Dr. Strange is an assistant professor in the department of psychiatry at the University of Vermont Medical Center and University of Vermont Robert Larner College of Medicine, both in Burlington. She works with children and adolescents. She has no relevant financial disclosures

References

1. Rathus JH, Miller AL. DBT® Skills manual for adolescents. 2015. Guilford Press.

2. Guided Relaxation Exercises, Children’s Hospital of Philadelphia.

3. Vermont Center for Children, Youth, and Families: Staying Close While Keeping Your Distance.
 

Taking teens’ strengths, values, and dreams, into account through a previsit questionnaire was acceptable to them and may promote discussions with providers, based on data from 91 adolescents.

The American Academy of Pediatrics’ Bright Futures initiative recommends the use of a strength-based approach for adolescent well visits, but the extensive positive psychology inventories to identify teen strengths and values are impractical for the clinical visit setting, wrote Yidan Cao, MPH, of the Child Development through Primary Care at the University of Michigan, Ann Arbor, and colleagues. However, 76% of youth participating in focus groups responded that “using a confidential questionnaire about a teen’s strengths and goals before checkup visits would be a good addition to health care for teens,” the researchers said.

In a study presented in a poster session (#515) at the Pediatric Academic Societies annual meeting, the researchers recruited 91 community youth to participate in 13 focus groups related to teen depression and substance use. The age of the focus group participants ranged from 12 to 18 years, with an average of 15 years, 61.5% were female, and 1.1% identified as transgender. The racial breakdown was 51.6% White, 27.5% African American, 8.8% Asian, 2.2% Native American, 3.3% biracial, and 6.6% unknown.

The participants provided information on potential questionnaire items for an online previsit screening for well visits to assess strengths and identify values, goals, dream jobs, and life wishes.

Suggestions from the participants informed changes to the questionnaire, which included five categories: personal/social goals, goals for academics/training, strengths, values, and dream jobs.

The top endorsed personal goal of “to be happy” was chosen by 13.1% of the participants. The top academic goal was “get good grades” (45.5%). The top endorsed strength was “fitness/coordination/sports/physical activity” (22.9%), while the top value was caring and kindness (25.8%), and the top dream job category was health/medical (30.8%).

Key comments made by the youth participants for improving the previsit questionnaire included adding an option for “I can’t decide,” and allowing for multiple responses to avoid feeling pinned down or judged, the researchers noted.

The researchers highlighted one teen comment: “While I understand the purpose of limiting the participants to two answers, it is incredibly difficult to only choose two. Being limited to two very much restricts your understanding of our values. For example, I would’ve also liked to select ‘to do well in school’ and ‘to make a difference,’ but ‘being happy’ and ‘being loving to all those around me’ had to take precedent.”

The study was limited by not being fully generalizable to all teens, as other teens may hold views and beliefs that differ from those of the focus group participants, the researchers noted.

However, the findings support the value of a strength-based previsit questionnaire for adolescents, they said.

“Structured previsit data could facilitate relationship building and be actionable for assigning strength and resiliency building resources,” they noted. “A final strengths and goals questionnaire is now being piloted in computerized form contributing to decision supports for suggested teleprompters and associated resource options,” and future research may show the value of such previsit data for improved clinical process and outcomes of youth well visits, they concluded.

Recognize the uncertainty of adolescence

“Adolescents are at crossroads of identity, trying to figure out who they are, their goals and values,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview. “Adolescence is also a critical time when teens have more control and choice over behaviors that impact their health, such as diet, exercise, substance use, and sexual activity. In this critical time period, clinicians can intervene on health-related behaviors and shape the trajectory of a teen’s life. However, to promote teen health, pediatricians need to have their patients’ trust, which can be hard to gain,” she emphasized.

“In my practice, I’ve found that teens often just want to be seen and heard,” said Dr. Curran. “Teens often have many adults in their life who focus on the ‘don’ts’ – don’t use drugs, don’t have sex, for example – and few that praise healthy behaviors or strengths, or seek to understand what is important to them. By listening to teens and understanding what’s important to them, we can then use motivational interviewing techniques to help create meaningful change in health-related behaviors. However, this takes time and investment, which is often in conflict with time pressures in the modern medical system.

“This study is useful because it examined the acceptability of a positive psychology questionnaire to be used at well visits when reviewed by youth, that could be used to streamline this important process,” said Dr. Curran.

“From my practice, I know that understanding a teen’s goals, values, and strengths is important – we do this daily in our practice when working with patients – but it was exciting to see that youth found it acceptable to do this via a previsit survey, which can potentially streamline well visits,” she noted.

The questionnaire is being developed as a pilot program, but more research is needed to determine the direct clinical impact, said Dr. Curran. “It will be important in the future to see if implementation of this questionnaire can be helpful in integrating this information into motivational interviewing and rapport building to help improve teens’ health outcomes.”

The study was supported in part by the National Institute on Drug Abuse and the National Institute of Mental Health. Two coauthors have a financial interest in the CHADIS online reporting program used in the study. Dr. Curran had no financial conflicts to disclose.

Taking teens’ strengths, values, and dreams, into account through a previsit questionnaire was acceptable to them and may promote discussions with providers, based on data from 91 adolescents.

The American Academy of Pediatrics’ Bright Futures initiative recommends the use of a strength-based approach for adolescent well visits, but the extensive positive psychology inventories to identify teen strengths and values are impractical for the clinical visit setting, wrote Yidan Cao, MPH, of the Child Development through Primary Care at the University of Michigan, Ann Arbor, and colleagues. However, 76% of youth participating in focus groups responded that “using a confidential questionnaire about a teen’s strengths and goals before checkup visits would be a good addition to health care for teens,” the researchers said.

In a study presented in a poster session (#515) at the Pediatric Academic Societies annual meeting, the researchers recruited 91 community youth to participate in 13 focus groups related to teen depression and substance use. The age of the focus group participants ranged from 12 to 18 years, with an average of 15 years, 61.5% were female, and 1.1% identified as transgender. The racial breakdown was 51.6% White, 27.5% African American, 8.8% Asian, 2.2% Native American, 3.3% biracial, and 6.6% unknown.

The participants provided information on potential questionnaire items for an online previsit screening for well visits to assess strengths and identify values, goals, dream jobs, and life wishes.

Suggestions from the participants informed changes to the questionnaire, which included five categories: personal/social goals, goals for academics/training, strengths, values, and dream jobs.

The top endorsed personal goal of “to be happy” was chosen by 13.1% of the participants. The top academic goal was “get good grades” (45.5%). The top endorsed strength was “fitness/coordination/sports/physical activity” (22.9%), while the top value was caring and kindness (25.8%), and the top dream job category was health/medical (30.8%).

Key comments made by the youth participants for improving the previsit questionnaire included adding an option for “I can’t decide,” and allowing for multiple responses to avoid feeling pinned down or judged, the researchers noted.

The researchers highlighted one teen comment: “While I understand the purpose of limiting the participants to two answers, it is incredibly difficult to only choose two. Being limited to two very much restricts your understanding of our values. For example, I would’ve also liked to select ‘to do well in school’ and ‘to make a difference,’ but ‘being happy’ and ‘being loving to all those around me’ had to take precedent.”

The study was limited by not being fully generalizable to all teens, as other teens may hold views and beliefs that differ from those of the focus group participants, the researchers noted.

However, the findings support the value of a strength-based previsit questionnaire for adolescents, they said.

“Structured previsit data could facilitate relationship building and be actionable for assigning strength and resiliency building resources,” they noted. “A final strengths and goals questionnaire is now being piloted in computerized form contributing to decision supports for suggested teleprompters and associated resource options,” and future research may show the value of such previsit data for improved clinical process and outcomes of youth well visits, they concluded.

Recognize the uncertainty of adolescence

“Adolescents are at crossroads of identity, trying to figure out who they are, their goals and values,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview. “Adolescence is also a critical time when teens have more control and choice over behaviors that impact their health, such as diet, exercise, substance use, and sexual activity. In this critical time period, clinicians can intervene on health-related behaviors and shape the trajectory of a teen’s life. However, to promote teen health, pediatricians need to have their patients’ trust, which can be hard to gain,” she emphasized.

“In my practice, I’ve found that teens often just want to be seen and heard,” said Dr. Curran. “Teens often have many adults in their life who focus on the ‘don’ts’ – don’t use drugs, don’t have sex, for example – and few that praise healthy behaviors or strengths, or seek to understand what is important to them. By listening to teens and understanding what’s important to them, we can then use motivational interviewing techniques to help create meaningful change in health-related behaviors. However, this takes time and investment, which is often in conflict with time pressures in the modern medical system.

“This study is useful because it examined the acceptability of a positive psychology questionnaire to be used at well visits when reviewed by youth, that could be used to streamline this important process,” said Dr. Curran.

“From my practice, I know that understanding a teen’s goals, values, and strengths is important – we do this daily in our practice when working with patients – but it was exciting to see that youth found it acceptable to do this via a previsit survey, which can potentially streamline well visits,” she noted.

The questionnaire is being developed as a pilot program, but more research is needed to determine the direct clinical impact, said Dr. Curran. “It will be important in the future to see if implementation of this questionnaire can be helpful in integrating this information into motivational interviewing and rapport building to help improve teens’ health outcomes.”

The study was supported in part by the National Institute on Drug Abuse and the National Institute of Mental Health. Two coauthors have a financial interest in the CHADIS online reporting program used in the study. Dr. Curran had no financial conflicts to disclose.

Taking teens’ strengths, values, and dreams, into account through a previsit questionnaire was acceptable to them and may promote discussions with providers, based on data from 91 adolescents.

The American Academy of Pediatrics’ Bright Futures initiative recommends the use of a strength-based approach for adolescent well visits, but the extensive positive psychology inventories to identify teen strengths and values are impractical for the clinical visit setting, wrote Yidan Cao, MPH, of the Child Development through Primary Care at the University of Michigan, Ann Arbor, and colleagues. However, 76% of youth participating in focus groups responded that “using a confidential questionnaire about a teen’s strengths and goals before checkup visits would be a good addition to health care for teens,” the researchers said.

In a study presented in a poster session (#515) at the Pediatric Academic Societies annual meeting, the researchers recruited 91 community youth to participate in 13 focus groups related to teen depression and substance use. The age of the focus group participants ranged from 12 to 18 years, with an average of 15 years, 61.5% were female, and 1.1% identified as transgender. The racial breakdown was 51.6% White, 27.5% African American, 8.8% Asian, 2.2% Native American, 3.3% biracial, and 6.6% unknown.

The participants provided information on potential questionnaire items for an online previsit screening for well visits to assess strengths and identify values, goals, dream jobs, and life wishes.

Suggestions from the participants informed changes to the questionnaire, which included five categories: personal/social goals, goals for academics/training, strengths, values, and dream jobs.

The top endorsed personal goal of “to be happy” was chosen by 13.1% of the participants. The top academic goal was “get good grades” (45.5%). The top endorsed strength was “fitness/coordination/sports/physical activity” (22.9%), while the top value was caring and kindness (25.8%), and the top dream job category was health/medical (30.8%).

Key comments made by the youth participants for improving the previsit questionnaire included adding an option for “I can’t decide,” and allowing for multiple responses to avoid feeling pinned down or judged, the researchers noted.

The researchers highlighted one teen comment: “While I understand the purpose of limiting the participants to two answers, it is incredibly difficult to only choose two. Being limited to two very much restricts your understanding of our values. For example, I would’ve also liked to select ‘to do well in school’ and ‘to make a difference,’ but ‘being happy’ and ‘being loving to all those around me’ had to take precedent.”

The study was limited by not being fully generalizable to all teens, as other teens may hold views and beliefs that differ from those of the focus group participants, the researchers noted.

However, the findings support the value of a strength-based previsit questionnaire for adolescents, they said.

“Structured previsit data could facilitate relationship building and be actionable for assigning strength and resiliency building resources,” they noted. “A final strengths and goals questionnaire is now being piloted in computerized form contributing to decision supports for suggested teleprompters and associated resource options,” and future research may show the value of such previsit data for improved clinical process and outcomes of youth well visits, they concluded.

Recognize the uncertainty of adolescence

“Adolescents are at crossroads of identity, trying to figure out who they are, their goals and values,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, in an interview. “Adolescence is also a critical time when teens have more control and choice over behaviors that impact their health, such as diet, exercise, substance use, and sexual activity. In this critical time period, clinicians can intervene on health-related behaviors and shape the trajectory of a teen’s life. However, to promote teen health, pediatricians need to have their patients’ trust, which can be hard to gain,” she emphasized.

“In my practice, I’ve found that teens often just want to be seen and heard,” said Dr. Curran. “Teens often have many adults in their life who focus on the ‘don’ts’ – don’t use drugs, don’t have sex, for example – and few that praise healthy behaviors or strengths, or seek to understand what is important to them. By listening to teens and understanding what’s important to them, we can then use motivational interviewing techniques to help create meaningful change in health-related behaviors. However, this takes time and investment, which is often in conflict with time pressures in the modern medical system.

“This study is useful because it examined the acceptability of a positive psychology questionnaire to be used at well visits when reviewed by youth, that could be used to streamline this important process,” said Dr. Curran.

“From my practice, I know that understanding a teen’s goals, values, and strengths is important – we do this daily in our practice when working with patients – but it was exciting to see that youth found it acceptable to do this via a previsit survey, which can potentially streamline well visits,” she noted.

The questionnaire is being developed as a pilot program, but more research is needed to determine the direct clinical impact, said Dr. Curran. “It will be important in the future to see if implementation of this questionnaire can be helpful in integrating this information into motivational interviewing and rapport building to help improve teens’ health outcomes.”

The study was supported in part by the National Institute on Drug Abuse and the National Institute of Mental Health. Two coauthors have a financial interest in the CHADIS online reporting program used in the study. Dr. Curran had no financial conflicts to disclose.

In her welcome video on the opening day at the annual meeting of the Society of General Internal Medicine, meeting chair Rita Lee, MD, said she hoped that this year’s event, though virtual, will allow attendees an opportunity to “regroup, find inspiration, and celebrate the incredible strengths and diverse voices of our community.”

“We are living in an incredibly polarized world,” Dr. Lee said in an interview. “The conference theme of ‘Transforming Values Into Action’ is especially important at this time, as recent events, such as the death of George Floyd and many others, plus the disparities revealed by the COVID-19 pandemic, have brought issues of structural racism and oppression in the United States to the forefront,” she said in the interview.

“Given these circumstances, it is important now, more than ever, for generalists to move our values into action – to effect change at the health system, community, and policy levels – so our patients can achieve optimal health,” Dr. Lee emphasized.

She noted that SGIM’s vision: “A just system of care in which all people can achieve optimal health,” underlies the meeting’s sessions.

Some challenges related to adopting more antiracist training in medical education center on faculty development, Dr. Lee noted. “There are also students who don’t feel that this is part of the role of being a physician. One way to overcome these challenges is by directly linking structural competency to health outcomes for our patients,” she added. “We have evidence that structural racism impacts health and we should make that clear to our educational leaders and faculty to increase buy in. So many of our SGIM members are working on developing curricula for this.”

Two of the meeting’s workshops that addressed racism in medicine and medical education and strategies for change were “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” and “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today.” Below are some details about these.
 

Medical education evolves to include structural competency

In the workshop “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” participants used interactive exercises to build structural differentials for patient cases. The workshop was based in part on the experiences of including structural competency in medical education at Albert Einstein College of Medicine, New York, and the University of Pittsburgh.

During the session, participants practiced building a structural differential diagnosis in small groups, and also practiced using a structurally competent version of the 1-minute preceptor to promote structural competency in learners.

“Structural competency represents a shift in medical education towards attention to forces that influence health outcomes at levels above individual clinical interactions and develop a provider’s capacity to recognize and respond to health and illness as downstream effects of social, political and economic structures,” presenter Iman Hassan, MD, of Albert Einstein College of Medicine and Montefiore Health System, both in New York, said in an interview.

“At the same time, structural competency incorporates structural humility, which decentralizes the provider role in addressing structural factors and emphasizes collaboration with patients and communities,” she said in the interview. “Structural competency is a useful antiracism framework because it explicitly engages learners with the broader structural forces that result in health disparities, including structural racism and its downstream effects,” Dr. Hassan explained.

Addressing structural competency is important in medical education because structural and social determinants of health contribute more than half of overall health outcomes, said Dr. Hassan.

A structural competency framework equips learners to identify, discuss, and work with patients to navigate social needs such as lack of health insurance, food, or transportation, that are preventing them from accessing needed health care services, Dr. Hassan noted.

“Importantly, training in structural competency empowers physicians to be agents of change within their clinics, health systems, and communities and to recognize the value of community-led advocacy in promoting health equity,” she said.

Structural competency training also “will also allow them to engage more fully with the body of literature that exists surrounding social determinants of health and health disparities, and the use of approaches such as critical race theory through which to view health care,” she emphasized. “Importantly, understanding of the historical and structural context of medicine allows clinicians to more readily recognize when their own clinical practices, such as use of race-based clinical prediction tools, may perpetuate disparities, and work collectively to eliminate those practices.”
 

Recalibrating calculators for clinical care

Another workshop, “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today,” took on the challenge of inherent bias in clinical care caused by various factors, notably medical calculators such as those used to measure kidney function and pulmonary function.

Lamar K. Johnson, MD, of Christiana Care Hospital Partners/Christiana Care Pediatric Hospitalists in Newark, Del., and Celeste Newby, MD, of Tulane University, New Orleans, discussed the inherent biases in some calculators and how to take those biases into account. A stated goal of the workshop was to increase awareness of the origins of medical calculators in order to enhance equity and improve shared decision-making between patients and providers.

Addressing implicit bias in clinical practice is important because such bias has been shown to negatively affect physician behavior and clinical decision making, Dr. Johnson said in an interview.

“These effects can also negatively affect the doctor-patient relationship and lead to poorer health outcomes due to delays in or avoidance of care or avoidance of the health care system, and mistrust, resulting in nonadherence,” Dr. Johnson noted.

“Implicit bias training helps empower medical students and residents to recognize and address bias and advocate for patients. Such training can potentially be beneficial to faculty, too,” Dr. Johnson emphasized in the interview.

“Race is primarily a social, not a biological, construct, and we must be careful when we use it, as its use in the past has been largely inappropriate and not scientifically sound,” he said.

During the session, one of the presenters said removing specific mentions of race from clinical documentation can reduce racial bias in clinical practice.

The presenters also highlighted the estimated glomerular filtration rate (eGFR) which is used to estimate kidney function.

The eGFR “reports higher eGFR values for Blacks based on a faulty hypothesis that Black people have higher muscle mass. This higher estimated value can delay referral for specialist care or transplantation, leading to worse outcomes,” Dr. Johnson explained in the interview.

In response, “Many major institutions have eliminated the race modifier in eGFR, and a joint task force created by the National Kidney Foundation and American Society of Nephrology has recommended against using a race modifier as of March 2021,” Dr. Johnson said.

The presenters had no relevant financial conflicts to disclose.

In her welcome video on the opening day at the annual meeting of the Society of General Internal Medicine, meeting chair Rita Lee, MD, said she hoped that this year’s event, though virtual, will allow attendees an opportunity to “regroup, find inspiration, and celebrate the incredible strengths and diverse voices of our community.”

“We are living in an incredibly polarized world,” Dr. Lee said in an interview. “The conference theme of ‘Transforming Values Into Action’ is especially important at this time, as recent events, such as the death of George Floyd and many others, plus the disparities revealed by the COVID-19 pandemic, have brought issues of structural racism and oppression in the United States to the forefront,” she said in the interview.

“Given these circumstances, it is important now, more than ever, for generalists to move our values into action – to effect change at the health system, community, and policy levels – so our patients can achieve optimal health,” Dr. Lee emphasized.

She noted that SGIM’s vision: “A just system of care in which all people can achieve optimal health,” underlies the meeting’s sessions.

Some challenges related to adopting more antiracist training in medical education center on faculty development, Dr. Lee noted. “There are also students who don’t feel that this is part of the role of being a physician. One way to overcome these challenges is by directly linking structural competency to health outcomes for our patients,” she added. “We have evidence that structural racism impacts health and we should make that clear to our educational leaders and faculty to increase buy in. So many of our SGIM members are working on developing curricula for this.”

Two of the meeting’s workshops that addressed racism in medicine and medical education and strategies for change were “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” and “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today.” Below are some details about these.
 

Medical education evolves to include structural competency

In the workshop “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” participants used interactive exercises to build structural differentials for patient cases. The workshop was based in part on the experiences of including structural competency in medical education at Albert Einstein College of Medicine, New York, and the University of Pittsburgh.

During the session, participants practiced building a structural differential diagnosis in small groups, and also practiced using a structurally competent version of the 1-minute preceptor to promote structural competency in learners.

“Structural competency represents a shift in medical education towards attention to forces that influence health outcomes at levels above individual clinical interactions and develop a provider’s capacity to recognize and respond to health and illness as downstream effects of social, political and economic structures,” presenter Iman Hassan, MD, of Albert Einstein College of Medicine and Montefiore Health System, both in New York, said in an interview.

“At the same time, structural competency incorporates structural humility, which decentralizes the provider role in addressing structural factors and emphasizes collaboration with patients and communities,” she said in the interview. “Structural competency is a useful antiracism framework because it explicitly engages learners with the broader structural forces that result in health disparities, including structural racism and its downstream effects,” Dr. Hassan explained.

Addressing structural competency is important in medical education because structural and social determinants of health contribute more than half of overall health outcomes, said Dr. Hassan.

A structural competency framework equips learners to identify, discuss, and work with patients to navigate social needs such as lack of health insurance, food, or transportation, that are preventing them from accessing needed health care services, Dr. Hassan noted.

“Importantly, training in structural competency empowers physicians to be agents of change within their clinics, health systems, and communities and to recognize the value of community-led advocacy in promoting health equity,” she said.

Structural competency training also “will also allow them to engage more fully with the body of literature that exists surrounding social determinants of health and health disparities, and the use of approaches such as critical race theory through which to view health care,” she emphasized. “Importantly, understanding of the historical and structural context of medicine allows clinicians to more readily recognize when their own clinical practices, such as use of race-based clinical prediction tools, may perpetuate disparities, and work collectively to eliminate those practices.”
 

Recalibrating calculators for clinical care

Another workshop, “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today,” took on the challenge of inherent bias in clinical care caused by various factors, notably medical calculators such as those used to measure kidney function and pulmonary function.

Lamar K. Johnson, MD, of Christiana Care Hospital Partners/Christiana Care Pediatric Hospitalists in Newark, Del., and Celeste Newby, MD, of Tulane University, New Orleans, discussed the inherent biases in some calculators and how to take those biases into account. A stated goal of the workshop was to increase awareness of the origins of medical calculators in order to enhance equity and improve shared decision-making between patients and providers.

Addressing implicit bias in clinical practice is important because such bias has been shown to negatively affect physician behavior and clinical decision making, Dr. Johnson said in an interview.

“These effects can also negatively affect the doctor-patient relationship and lead to poorer health outcomes due to delays in or avoidance of care or avoidance of the health care system, and mistrust, resulting in nonadherence,” Dr. Johnson noted.

“Implicit bias training helps empower medical students and residents to recognize and address bias and advocate for patients. Such training can potentially be beneficial to faculty, too,” Dr. Johnson emphasized in the interview.

“Race is primarily a social, not a biological, construct, and we must be careful when we use it, as its use in the past has been largely inappropriate and not scientifically sound,” he said.

During the session, one of the presenters said removing specific mentions of race from clinical documentation can reduce racial bias in clinical practice.

The presenters also highlighted the estimated glomerular filtration rate (eGFR) which is used to estimate kidney function.

The eGFR “reports higher eGFR values for Blacks based on a faulty hypothesis that Black people have higher muscle mass. This higher estimated value can delay referral for specialist care or transplantation, leading to worse outcomes,” Dr. Johnson explained in the interview.

In response, “Many major institutions have eliminated the race modifier in eGFR, and a joint task force created by the National Kidney Foundation and American Society of Nephrology has recommended against using a race modifier as of March 2021,” Dr. Johnson said.

The presenters had no relevant financial conflicts to disclose.

In her welcome video on the opening day at the annual meeting of the Society of General Internal Medicine, meeting chair Rita Lee, MD, said she hoped that this year’s event, though virtual, will allow attendees an opportunity to “regroup, find inspiration, and celebrate the incredible strengths and diverse voices of our community.”

“We are living in an incredibly polarized world,” Dr. Lee said in an interview. “The conference theme of ‘Transforming Values Into Action’ is especially important at this time, as recent events, such as the death of George Floyd and many others, plus the disparities revealed by the COVID-19 pandemic, have brought issues of structural racism and oppression in the United States to the forefront,” she said in the interview.

“Given these circumstances, it is important now, more than ever, for generalists to move our values into action – to effect change at the health system, community, and policy levels – so our patients can achieve optimal health,” Dr. Lee emphasized.

She noted that SGIM’s vision: “A just system of care in which all people can achieve optimal health,” underlies the meeting’s sessions.

Some challenges related to adopting more antiracist training in medical education center on faculty development, Dr. Lee noted. “There are also students who don’t feel that this is part of the role of being a physician. One way to overcome these challenges is by directly linking structural competency to health outcomes for our patients,” she added. “We have evidence that structural racism impacts health and we should make that clear to our educational leaders and faculty to increase buy in. So many of our SGIM members are working on developing curricula for this.”

Two of the meeting’s workshops that addressed racism in medicine and medical education and strategies for change were “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” and “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today.” Below are some details about these.
 

Medical education evolves to include structural competency

In the workshop “Demystifying Structural Competency – How to Develop Antiracist Training in Medical Education,” participants used interactive exercises to build structural differentials for patient cases. The workshop was based in part on the experiences of including structural competency in medical education at Albert Einstein College of Medicine, New York, and the University of Pittsburgh.

During the session, participants practiced building a structural differential diagnosis in small groups, and also practiced using a structurally competent version of the 1-minute preceptor to promote structural competency in learners.

“Structural competency represents a shift in medical education towards attention to forces that influence health outcomes at levels above individual clinical interactions and develop a provider’s capacity to recognize and respond to health and illness as downstream effects of social, political and economic structures,” presenter Iman Hassan, MD, of Albert Einstein College of Medicine and Montefiore Health System, both in New York, said in an interview.

“At the same time, structural competency incorporates structural humility, which decentralizes the provider role in addressing structural factors and emphasizes collaboration with patients and communities,” she said in the interview. “Structural competency is a useful antiracism framework because it explicitly engages learners with the broader structural forces that result in health disparities, including structural racism and its downstream effects,” Dr. Hassan explained.

Addressing structural competency is important in medical education because structural and social determinants of health contribute more than half of overall health outcomes, said Dr. Hassan.

A structural competency framework equips learners to identify, discuss, and work with patients to navigate social needs such as lack of health insurance, food, or transportation, that are preventing them from accessing needed health care services, Dr. Hassan noted.

“Importantly, training in structural competency empowers physicians to be agents of change within their clinics, health systems, and communities and to recognize the value of community-led advocacy in promoting health equity,” she said.

Structural competency training also “will also allow them to engage more fully with the body of literature that exists surrounding social determinants of health and health disparities, and the use of approaches such as critical race theory through which to view health care,” she emphasized. “Importantly, understanding of the historical and structural context of medicine allows clinicians to more readily recognize when their own clinical practices, such as use of race-based clinical prediction tools, may perpetuate disparities, and work collectively to eliminate those practices.”
 

Recalibrating calculators for clinical care

Another workshop, “Combating Systemic Racism in the Health Care System – Practical Actions You Can Take Today,” took on the challenge of inherent bias in clinical care caused by various factors, notably medical calculators such as those used to measure kidney function and pulmonary function.

Lamar K. Johnson, MD, of Christiana Care Hospital Partners/Christiana Care Pediatric Hospitalists in Newark, Del., and Celeste Newby, MD, of Tulane University, New Orleans, discussed the inherent biases in some calculators and how to take those biases into account. A stated goal of the workshop was to increase awareness of the origins of medical calculators in order to enhance equity and improve shared decision-making between patients and providers.

Addressing implicit bias in clinical practice is important because such bias has been shown to negatively affect physician behavior and clinical decision making, Dr. Johnson said in an interview.

“These effects can also negatively affect the doctor-patient relationship and lead to poorer health outcomes due to delays in or avoidance of care or avoidance of the health care system, and mistrust, resulting in nonadherence,” Dr. Johnson noted.

“Implicit bias training helps empower medical students and residents to recognize and address bias and advocate for patients. Such training can potentially be beneficial to faculty, too,” Dr. Johnson emphasized in the interview.

“Race is primarily a social, not a biological, construct, and we must be careful when we use it, as its use in the past has been largely inappropriate and not scientifically sound,” he said.

During the session, one of the presenters said removing specific mentions of race from clinical documentation can reduce racial bias in clinical practice.

The presenters also highlighted the estimated glomerular filtration rate (eGFR) which is used to estimate kidney function.

The eGFR “reports higher eGFR values for Blacks based on a faulty hypothesis that Black people have higher muscle mass. This higher estimated value can delay referral for specialist care or transplantation, leading to worse outcomes,” Dr. Johnson explained in the interview.

In response, “Many major institutions have eliminated the race modifier in eGFR, and a joint task force created by the National Kidney Foundation and American Society of Nephrology has recommended against using a race modifier as of March 2021,” Dr. Johnson said.

The presenters had no relevant financial conflicts to disclose.

Noninvasive brain stimulation has the potential to boost a patient’s placebo experience or blunt the nocebo experience, according to results of a new study published in the Proceedings of the National Academy of Sciences (PNAS).

“Placebo and nocebo effects are a critical component of clinical care and efficacy studies,” said senior author Jian Kong, MD, associate professor in the department of psychiatry at Massachusetts General Hospital, Charlestown campus. “Harnessing these effects in clinical practice and research could facilitate the development of new pain management methods,” he said. “Healing may involve multiple components: the self-healing properties of the body; the nonspecific effects of treatment (i.e., placebo effect); and the specific effect of a physical or pharmacologic intervention. Therefore, enhancing the placebo effect may ultimately boost the overall therapeutic effect of existing treatment,” he explained, emphasizing that the results are preliminary and should be interpreted with caution.

The authors noted that reducing nocebo effects could also be a major benefit “since patients discontinue prescribed medications, make unnecessary medical visits, and take additional medications to counteract adverse effects that are actually nocebo effects.”


 

Testing the hypothesis

The randomized, double-blind, sham-controlled study used transcranial direct current stimulation (tDCS), which delivers an electrical current to the brain via scalp electrodes. The aim was to see if stimulating the dorsolateral prefrontal cortex with tDCS could alter the brain’s perception of placebo and nocebo experiences.

The study included 81 participants (37 females, mean age: 27.4 years), who were randomized into one of three tDCS groups (anodal, cathodal, or sham).

All participants were first conditioned to believe that an inert cream was either lidocaine or capsaicin and that this cream could either dull the impact of a painful heat stimulus (placebo analgesia) or exacerbate it (nocebo hyperalgesia). Participants were then placed into a functional MRI scanner where tDCS was initiated. Painful stimuli were then applied to spots on their forearms where they believed they had either lidocaine, capsaicin, or a neutral control cream and they rated the pain using the Gracely Sensory Scale.

Placebo analgesia was defined as the difference between perceived pain intensity where participants believed they had lidocaine cream compared with where they believed they had control cream. Nocebo hyperalgesia was defined as the difference between perceived pain intensity where they believed they had capsaicin cream compared with where they believed they had control cream.

The researchers found that compared with sham tDCS, cathodal tDCS showed significant effects in increasing placebo analgesia and brain responses in the ventromedial prefrontal cortex (vmPFC), while anodal tDCS showed significant effects in inhibiting nocebo hyperalgesia and brain responses in the insula.

“The potential to enhance salubrious placebo effects and/or diminish treatment-interfering nocebo effects may have clinical significance,” the authors noted. “For example, clinical studies have suggested that expectancy is positively associated with chronic pain improvement, and using conditioning-like expectancy manipulation, we have shown that significantly boosting expectancy can improve treatment outcome.”
 

Proof of concept

Asked to comment on the study, Brian E. McGeeney, MD, of the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital in Boston, said “the findings are a proof of concept that it is possible to use noninvasive brain stimulation to modulate placebo and nocebo pain effects.”

Although the findings do not have immediate clinical application, they are “exciting” and “break new ground in expectancy research,” he said.

“It is important to recognize that the researchers are trying to utilize a purported expectancy mechanism rather than attempting to alter placebo/nocebo by verbal and other cues. It remains to be seen whether the manipulation of brief experimental pain like this can translate into altered chronic pain over time, the main clinical goal. Current tDCS therapy for various reasons is necessarily brief and one can ask whether there are meaningful changes from brief stimulation. Such results can foster speculation as to whether direct strategic placement of intracranial stimulation leads could result in more longstanding similar benefits.”

Dr. Kong holds equity in a startup company (MNT) and a pending patent to develop new peripheral neuromodulation tools, but declares no conflict of interest. All other authors declare no conflict of interest.

Noninvasive brain stimulation has the potential to boost a patient’s placebo experience or blunt the nocebo experience, according to results of a new study published in the Proceedings of the National Academy of Sciences (PNAS).

“Placebo and nocebo effects are a critical component of clinical care and efficacy studies,” said senior author Jian Kong, MD, associate professor in the department of psychiatry at Massachusetts General Hospital, Charlestown campus. “Harnessing these effects in clinical practice and research could facilitate the development of new pain management methods,” he said. “Healing may involve multiple components: the self-healing properties of the body; the nonspecific effects of treatment (i.e., placebo effect); and the specific effect of a physical or pharmacologic intervention. Therefore, enhancing the placebo effect may ultimately boost the overall therapeutic effect of existing treatment,” he explained, emphasizing that the results are preliminary and should be interpreted with caution.

The authors noted that reducing nocebo effects could also be a major benefit “since patients discontinue prescribed medications, make unnecessary medical visits, and take additional medications to counteract adverse effects that are actually nocebo effects.”


 

Testing the hypothesis

The randomized, double-blind, sham-controlled study used transcranial direct current stimulation (tDCS), which delivers an electrical current to the brain via scalp electrodes. The aim was to see if stimulating the dorsolateral prefrontal cortex with tDCS could alter the brain’s perception of placebo and nocebo experiences.

The study included 81 participants (37 females, mean age: 27.4 years), who were randomized into one of three tDCS groups (anodal, cathodal, or sham).

All participants were first conditioned to believe that an inert cream was either lidocaine or capsaicin and that this cream could either dull the impact of a painful heat stimulus (placebo analgesia) or exacerbate it (nocebo hyperalgesia). Participants were then placed into a functional MRI scanner where tDCS was initiated. Painful stimuli were then applied to spots on their forearms where they believed they had either lidocaine, capsaicin, or a neutral control cream and they rated the pain using the Gracely Sensory Scale.

Placebo analgesia was defined as the difference between perceived pain intensity where participants believed they had lidocaine cream compared with where they believed they had control cream. Nocebo hyperalgesia was defined as the difference between perceived pain intensity where they believed they had capsaicin cream compared with where they believed they had control cream.

The researchers found that compared with sham tDCS, cathodal tDCS showed significant effects in increasing placebo analgesia and brain responses in the ventromedial prefrontal cortex (vmPFC), while anodal tDCS showed significant effects in inhibiting nocebo hyperalgesia and brain responses in the insula.

“The potential to enhance salubrious placebo effects and/or diminish treatment-interfering nocebo effects may have clinical significance,” the authors noted. “For example, clinical studies have suggested that expectancy is positively associated with chronic pain improvement, and using conditioning-like expectancy manipulation, we have shown that significantly boosting expectancy can improve treatment outcome.”
 

Proof of concept

Asked to comment on the study, Brian E. McGeeney, MD, of the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital in Boston, said “the findings are a proof of concept that it is possible to use noninvasive brain stimulation to modulate placebo and nocebo pain effects.”

Although the findings do not have immediate clinical application, they are “exciting” and “break new ground in expectancy research,” he said.

“It is important to recognize that the researchers are trying to utilize a purported expectancy mechanism rather than attempting to alter placebo/nocebo by verbal and other cues. It remains to be seen whether the manipulation of brief experimental pain like this can translate into altered chronic pain over time, the main clinical goal. Current tDCS therapy for various reasons is necessarily brief and one can ask whether there are meaningful changes from brief stimulation. Such results can foster speculation as to whether direct strategic placement of intracranial stimulation leads could result in more longstanding similar benefits.”

Dr. Kong holds equity in a startup company (MNT) and a pending patent to develop new peripheral neuromodulation tools, but declares no conflict of interest. All other authors declare no conflict of interest.

Noninvasive brain stimulation has the potential to boost a patient’s placebo experience or blunt the nocebo experience, according to results of a new study published in the Proceedings of the National Academy of Sciences (PNAS).

“Placebo and nocebo effects are a critical component of clinical care and efficacy studies,” said senior author Jian Kong, MD, associate professor in the department of psychiatry at Massachusetts General Hospital, Charlestown campus. “Harnessing these effects in clinical practice and research could facilitate the development of new pain management methods,” he said. “Healing may involve multiple components: the self-healing properties of the body; the nonspecific effects of treatment (i.e., placebo effect); and the specific effect of a physical or pharmacologic intervention. Therefore, enhancing the placebo effect may ultimately boost the overall therapeutic effect of existing treatment,” he explained, emphasizing that the results are preliminary and should be interpreted with caution.

The authors noted that reducing nocebo effects could also be a major benefit “since patients discontinue prescribed medications, make unnecessary medical visits, and take additional medications to counteract adverse effects that are actually nocebo effects.”


 

Testing the hypothesis

The randomized, double-blind, sham-controlled study used transcranial direct current stimulation (tDCS), which delivers an electrical current to the brain via scalp electrodes. The aim was to see if stimulating the dorsolateral prefrontal cortex with tDCS could alter the brain’s perception of placebo and nocebo experiences.

The study included 81 participants (37 females, mean age: 27.4 years), who were randomized into one of three tDCS groups (anodal, cathodal, or sham).

All participants were first conditioned to believe that an inert cream was either lidocaine or capsaicin and that this cream could either dull the impact of a painful heat stimulus (placebo analgesia) or exacerbate it (nocebo hyperalgesia). Participants were then placed into a functional MRI scanner where tDCS was initiated. Painful stimuli were then applied to spots on their forearms where they believed they had either lidocaine, capsaicin, or a neutral control cream and they rated the pain using the Gracely Sensory Scale.

Placebo analgesia was defined as the difference between perceived pain intensity where participants believed they had lidocaine cream compared with where they believed they had control cream. Nocebo hyperalgesia was defined as the difference between perceived pain intensity where they believed they had capsaicin cream compared with where they believed they had control cream.

The researchers found that compared with sham tDCS, cathodal tDCS showed significant effects in increasing placebo analgesia and brain responses in the ventromedial prefrontal cortex (vmPFC), while anodal tDCS showed significant effects in inhibiting nocebo hyperalgesia and brain responses in the insula.

“The potential to enhance salubrious placebo effects and/or diminish treatment-interfering nocebo effects may have clinical significance,” the authors noted. “For example, clinical studies have suggested that expectancy is positively associated with chronic pain improvement, and using conditioning-like expectancy manipulation, we have shown that significantly boosting expectancy can improve treatment outcome.”
 

Proof of concept

Asked to comment on the study, Brian E. McGeeney, MD, of the John R. Graham Headache Center at Brigham and Women’s Faulkner Hospital in Boston, said “the findings are a proof of concept that it is possible to use noninvasive brain stimulation to modulate placebo and nocebo pain effects.”

Although the findings do not have immediate clinical application, they are “exciting” and “break new ground in expectancy research,” he said.

“It is important to recognize that the researchers are trying to utilize a purported expectancy mechanism rather than attempting to alter placebo/nocebo by verbal and other cues. It remains to be seen whether the manipulation of brief experimental pain like this can translate into altered chronic pain over time, the main clinical goal. Current tDCS therapy for various reasons is necessarily brief and one can ask whether there are meaningful changes from brief stimulation. Such results can foster speculation as to whether direct strategic placement of intracranial stimulation leads could result in more longstanding similar benefits.”

Dr. Kong holds equity in a startup company (MNT) and a pending patent to develop new peripheral neuromodulation tools, but declares no conflict of interest. All other authors declare no conflict of interest.

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

A version of this article first appeared on Medscape.com.

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

A version of this article first appeared on Medscape.com.

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

A version of this article first appeared on Medscape.com.