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One in four feel fully recovered following COVID-19 hospitalization
One year after hospitalization for COVID-19 only a minority of people feel fully recovered, with being female, obesity, and having had mechanical ventilation in hospital risk factors for not feeling fully recovered.
In the new U.K. study of more than 2,000 patients, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), and published in The Lancet Respiratory Medicine, research showed that one in four patients feel fully well again 1 year after hospitalization for COVID-19.
For their study, researchers from the University of Leicester used data from the post-hospitalization COVID-19 (PHOSP-COVID) prospective, longitudinal cohort study, which assessed adults aged 18 years and over who had been hospitalized with COVID-19 across the United Kingdom and subsequently discharged. The researchers assessed the recovery of 2,320 participants discharged from 39 U.K. hospitals between March 7, 2020, and April 18, 2021, who were assessed via patient-reported outcome measures, physical performance, and organ function at 5 months and at 1 year after hospital discharge. Blood samples were taken at the 5-month visit to be analyzed for the presence of various inflammatory proteins.
All participants were assessed at 5 months after discharge and 807 participants (33%) completed both the 5-month and 1-year visits at the time of the analysis. The study is ongoing. The 807 patients were mean age of 59 years, 36% were women, and 28% received invasive mechanical ventilation. The proportion of patients reporting full recovery was similar between 5 months (26%) and 1 year (29%).
Female sex and obesity major risk factors for not recovering
Being female, obese, and having had mechanical ventilation in hospital makes someone 32%, 50%, and 58%, respectively, less likely to feel fully recovered 1 year after COVID-19 hospitalization, the authors said.
“We found female sex and obesity were major risk factors for not recovering at one year,” said the researchers, led by Rachael Evans, PhD, Louise V. Wain, and Christopher E. Brightling, PhD, National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester.
The authors said fatigue, muscle pain, physically slowing down, poor sleep, and breathlessness were most common ongoing long COVID symptoms. They noted how the total number and range of ongoing symptoms at 1 year was “striking,” positively associated with the severity of long COVID, and emphasizes the “multisystem nature of long COVID.”
Several inflammatory mediators increased
An earlier publication from this study identified four groups or “clusters” of symptom severity at 5 months, which were confirmed by this new study at 1 year, the authors said. They reported that 20% had very severe physical and mental health impairment, 30% had severe physical and mental health impairment, 11% had moderate physical health impairment with cognitive impairment, and 39% had mild mental and physical health impairment.
They added that having obesity, reduced exercise capacity, a greater number of symptoms, and increased levels of C-reactive protein were associated with the “more severe clusters.” In both the very severe and the moderate with cognitive impairment clusters, levels of interleukin-6 (IL-6) were higher when compared with the mild cluster.
“The limited recovery from 5 months to 1 year after hospitalisation in our study across symptoms, mental health, exercise capacity, organ impairment, and quality-of-life is striking,” the researchers noted.
“In our clusters, female sex and obesity were also associated with more severe ongoing health impairments including reduced exercise performance and health-related quality of life at one year,” and suggested that this potentially highlighted a group that “might need higher intensity interventions such as supervised rehabilitation,” they added.
There are no specific therapeutics for long COVID, the researchers said, noting that “effective interventions are urgently required.” The persistent systemic inflammation identified, particularly in those in the very severe and moderate with cognitive impairment clusters, suggested that these groups “might respond to anti-inflammatory strategies,” the authors wrote.
“We found that a minority of participants felt fully recovered 1 year after hospital discharge, with minimal improvement after a 5-month assessment,” they noted.
They added that the findings suggest the need for complex interventions that target both physical and mental health impairments to alleviate symptoms, and that specific therapeutic approaches to manage posttraumatic stress disorder might also be needed. The authors pointed out how “pharmacological and non-pharmacological interventions are urgently needed,” with a “precision-medicine approach with potential treatable traits of systemic inflammation and obesity.”
They said their study highlighted the “urgent need for health-care services to support the large and rapidly increasing patient population in whom a substantial burden of symptoms exist, including reduced exercise capacity and substantially decreased health-related quality of life one year after hospital discharge.”
They warned that without effective treatments, long COVID could become a “highly prevalent new long-term condition.”
A version of this article first appeared on Medscape UK.
One year after hospitalization for COVID-19 only a minority of people feel fully recovered, with being female, obesity, and having had mechanical ventilation in hospital risk factors for not feeling fully recovered.
In the new U.K. study of more than 2,000 patients, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), and published in The Lancet Respiratory Medicine, research showed that one in four patients feel fully well again 1 year after hospitalization for COVID-19.
For their study, researchers from the University of Leicester used data from the post-hospitalization COVID-19 (PHOSP-COVID) prospective, longitudinal cohort study, which assessed adults aged 18 years and over who had been hospitalized with COVID-19 across the United Kingdom and subsequently discharged. The researchers assessed the recovery of 2,320 participants discharged from 39 U.K. hospitals between March 7, 2020, and April 18, 2021, who were assessed via patient-reported outcome measures, physical performance, and organ function at 5 months and at 1 year after hospital discharge. Blood samples were taken at the 5-month visit to be analyzed for the presence of various inflammatory proteins.
All participants were assessed at 5 months after discharge and 807 participants (33%) completed both the 5-month and 1-year visits at the time of the analysis. The study is ongoing. The 807 patients were mean age of 59 years, 36% were women, and 28% received invasive mechanical ventilation. The proportion of patients reporting full recovery was similar between 5 months (26%) and 1 year (29%).
Female sex and obesity major risk factors for not recovering
Being female, obese, and having had mechanical ventilation in hospital makes someone 32%, 50%, and 58%, respectively, less likely to feel fully recovered 1 year after COVID-19 hospitalization, the authors said.
“We found female sex and obesity were major risk factors for not recovering at one year,” said the researchers, led by Rachael Evans, PhD, Louise V. Wain, and Christopher E. Brightling, PhD, National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester.
The authors said fatigue, muscle pain, physically slowing down, poor sleep, and breathlessness were most common ongoing long COVID symptoms. They noted how the total number and range of ongoing symptoms at 1 year was “striking,” positively associated with the severity of long COVID, and emphasizes the “multisystem nature of long COVID.”
Several inflammatory mediators increased
An earlier publication from this study identified four groups or “clusters” of symptom severity at 5 months, which were confirmed by this new study at 1 year, the authors said. They reported that 20% had very severe physical and mental health impairment, 30% had severe physical and mental health impairment, 11% had moderate physical health impairment with cognitive impairment, and 39% had mild mental and physical health impairment.
They added that having obesity, reduced exercise capacity, a greater number of symptoms, and increased levels of C-reactive protein were associated with the “more severe clusters.” In both the very severe and the moderate with cognitive impairment clusters, levels of interleukin-6 (IL-6) were higher when compared with the mild cluster.
“The limited recovery from 5 months to 1 year after hospitalisation in our study across symptoms, mental health, exercise capacity, organ impairment, and quality-of-life is striking,” the researchers noted.
“In our clusters, female sex and obesity were also associated with more severe ongoing health impairments including reduced exercise performance and health-related quality of life at one year,” and suggested that this potentially highlighted a group that “might need higher intensity interventions such as supervised rehabilitation,” they added.
There are no specific therapeutics for long COVID, the researchers said, noting that “effective interventions are urgently required.” The persistent systemic inflammation identified, particularly in those in the very severe and moderate with cognitive impairment clusters, suggested that these groups “might respond to anti-inflammatory strategies,” the authors wrote.
“We found that a minority of participants felt fully recovered 1 year after hospital discharge, with minimal improvement after a 5-month assessment,” they noted.
They added that the findings suggest the need for complex interventions that target both physical and mental health impairments to alleviate symptoms, and that specific therapeutic approaches to manage posttraumatic stress disorder might also be needed. The authors pointed out how “pharmacological and non-pharmacological interventions are urgently needed,” with a “precision-medicine approach with potential treatable traits of systemic inflammation and obesity.”
They said their study highlighted the “urgent need for health-care services to support the large and rapidly increasing patient population in whom a substantial burden of symptoms exist, including reduced exercise capacity and substantially decreased health-related quality of life one year after hospital discharge.”
They warned that without effective treatments, long COVID could become a “highly prevalent new long-term condition.”
A version of this article first appeared on Medscape UK.
One year after hospitalization for COVID-19 only a minority of people feel fully recovered, with being female, obesity, and having had mechanical ventilation in hospital risk factors for not feeling fully recovered.
In the new U.K. study of more than 2,000 patients, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), and published in The Lancet Respiratory Medicine, research showed that one in four patients feel fully well again 1 year after hospitalization for COVID-19.
For their study, researchers from the University of Leicester used data from the post-hospitalization COVID-19 (PHOSP-COVID) prospective, longitudinal cohort study, which assessed adults aged 18 years and over who had been hospitalized with COVID-19 across the United Kingdom and subsequently discharged. The researchers assessed the recovery of 2,320 participants discharged from 39 U.K. hospitals between March 7, 2020, and April 18, 2021, who were assessed via patient-reported outcome measures, physical performance, and organ function at 5 months and at 1 year after hospital discharge. Blood samples were taken at the 5-month visit to be analyzed for the presence of various inflammatory proteins.
All participants were assessed at 5 months after discharge and 807 participants (33%) completed both the 5-month and 1-year visits at the time of the analysis. The study is ongoing. The 807 patients were mean age of 59 years, 36% were women, and 28% received invasive mechanical ventilation. The proportion of patients reporting full recovery was similar between 5 months (26%) and 1 year (29%).
Female sex and obesity major risk factors for not recovering
Being female, obese, and having had mechanical ventilation in hospital makes someone 32%, 50%, and 58%, respectively, less likely to feel fully recovered 1 year after COVID-19 hospitalization, the authors said.
“We found female sex and obesity were major risk factors for not recovering at one year,” said the researchers, led by Rachael Evans, PhD, Louise V. Wain, and Christopher E. Brightling, PhD, National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester.
The authors said fatigue, muscle pain, physically slowing down, poor sleep, and breathlessness were most common ongoing long COVID symptoms. They noted how the total number and range of ongoing symptoms at 1 year was “striking,” positively associated with the severity of long COVID, and emphasizes the “multisystem nature of long COVID.”
Several inflammatory mediators increased
An earlier publication from this study identified four groups or “clusters” of symptom severity at 5 months, which were confirmed by this new study at 1 year, the authors said. They reported that 20% had very severe physical and mental health impairment, 30% had severe physical and mental health impairment, 11% had moderate physical health impairment with cognitive impairment, and 39% had mild mental and physical health impairment.
They added that having obesity, reduced exercise capacity, a greater number of symptoms, and increased levels of C-reactive protein were associated with the “more severe clusters.” In both the very severe and the moderate with cognitive impairment clusters, levels of interleukin-6 (IL-6) were higher when compared with the mild cluster.
“The limited recovery from 5 months to 1 year after hospitalisation in our study across symptoms, mental health, exercise capacity, organ impairment, and quality-of-life is striking,” the researchers noted.
“In our clusters, female sex and obesity were also associated with more severe ongoing health impairments including reduced exercise performance and health-related quality of life at one year,” and suggested that this potentially highlighted a group that “might need higher intensity interventions such as supervised rehabilitation,” they added.
There are no specific therapeutics for long COVID, the researchers said, noting that “effective interventions are urgently required.” The persistent systemic inflammation identified, particularly in those in the very severe and moderate with cognitive impairment clusters, suggested that these groups “might respond to anti-inflammatory strategies,” the authors wrote.
“We found that a minority of participants felt fully recovered 1 year after hospital discharge, with minimal improvement after a 5-month assessment,” they noted.
They added that the findings suggest the need for complex interventions that target both physical and mental health impairments to alleviate symptoms, and that specific therapeutic approaches to manage posttraumatic stress disorder might also be needed. The authors pointed out how “pharmacological and non-pharmacological interventions are urgently needed,” with a “precision-medicine approach with potential treatable traits of systemic inflammation and obesity.”
They said their study highlighted the “urgent need for health-care services to support the large and rapidly increasing patient population in whom a substantial burden of symptoms exist, including reduced exercise capacity and substantially decreased health-related quality of life one year after hospital discharge.”
They warned that without effective treatments, long COVID could become a “highly prevalent new long-term condition.”
A version of this article first appeared on Medscape UK.
FROM THE LANCET RESPIRATORY MEDICINE
Endoscopic obesity treatments offer alternatives to surgery
SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.
Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.
Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”
Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.
Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m2 who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.
Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.
Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”
One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.
Balloon therapy should be highly individualized, according to Dr. Schulman.
Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.
In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.
ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.
During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.
“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.
Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.
Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.
“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.
Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.
Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.
SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.
Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.
Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”
Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.
Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m2 who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.
Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.
Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”
One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.
Balloon therapy should be highly individualized, according to Dr. Schulman.
Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.
In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.
ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.
During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.
“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.
Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.
Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.
“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.
Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.
Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.
SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.
Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.
Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”
Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.
Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m2 who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.
Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.
Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”
One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.
Balloon therapy should be highly individualized, according to Dr. Schulman.
Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.
In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.
ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.
During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.
“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.
Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.
Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.
“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.
Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.
Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.
AT 2022 AGA TECH SUMMIT
Complicated appendicitis during pregnancy: Immediate surgery may be best
Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.
Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.
“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.
The retrospective study was published in JAMA Network Open.
While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.
National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.
To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.
Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.
Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.
Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).
Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.
Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”
Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.
Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.
“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.
This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”
Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.
Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.
“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.
The retrospective study was published in JAMA Network Open.
While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.
National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.
To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.
Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.
Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.
Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).
Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.
Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”
Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.
Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.
“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.
This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”
Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.
Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.
“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.
The retrospective study was published in JAMA Network Open.
While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.
National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.
To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.
Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.
Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.
Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).
Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.
Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”
Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.
Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.
“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.
This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”
Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Three in four U.S. doctors are employed by hospitals, corporate entities: Report
Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.
, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.
“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”
Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.
“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”
More than half of physician practices owned by hospitals, corporate entities
The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.
“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”
According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.
From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.
Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.
The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.
Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.
Value-based care, venture capital firms driving change
Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”
Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.
Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?
“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”
The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.
A version of this article first appeared on Medscape.com.
Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.
, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.
“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”
Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.
“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”
More than half of physician practices owned by hospitals, corporate entities
The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.
“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”
According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.
From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.
Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.
The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.
Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.
Value-based care, venture capital firms driving change
Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”
Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.
Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?
“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”
The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.
A version of this article first appeared on Medscape.com.
Marcus Welby, MD, was a fictitious hometown doctor featured in a TV drama with the same name that was shown on ABC from 1969 to 1976. Played by actor Robert Young, Dr. Welby treated his patients through their bouts with breast cancer, impotence, and Alzheimer’s disease.
, according to a recent report sponsored by the Physicians Advocacy Institute and prepared by consulting firm Avalere Health.
“COVID-19 drove physicians to leave private practice for employment at an even more rapid pace than we’ve seen in recent years, and these trends continued to accelerate in 2021,” Kelly Kenney, chief executive officer of Physicians Advocacy Institute, said in an announcement. “This study underscores the fact that physicians across the nation are facing severe burnout and strain. The pressures of the pandemic forced many independent physicians to make difficult decisions to sell their practices, health insurers, or other corporate entities.”
Corporate entities are defined in the report as health insurers, private equity firms, and umbrella corporate entities that own multiple physician practices.
“The pandemic has been just brutal ... for nurses and physicians who are caring for patients,” Ms. Kenney told this news organization. “Between the financial stress that the pandemic certainly had on practices, because they certainly had little revenue for a while, and then also we know that the stress that physicians have felt mentally, you can’t overstate that.”
More than half of physician practices owned by hospitals, corporate entities
The Physicians Advocacy Institute has tracked changes in physician employment consistently since 2012, said Ms. Kenney. In 2012, 25% of physicians were employed; that has jumped to nearly 74%, which means the past decade has brought a world of change to the nation’s physicians.
“These are essentially small-business people ... and they were primarily trained to care for patients,” said Ms. Kenney, referring to physicians in independent practice. Still, she understands why physicians would seek employment in the face of “the crushing kind of pressure of having to deal with 20 different payers, pay overhead, and keep the lights on [at the practice].”
According to the report, 108,700 physicians left independent practice to enter employment with hospitals or other corporate entities in the 3-year period that ended in 2021. Seventy-six percent of that shift to employed status among physicians has occurred since the start of the COVID-19 pandemic in March 2020.
From a regional perspective, the report found continued growth among employed physicians across all U.S. regions in the last half of 2020. Hospital- or corporate-owned physician practices increased between 28% and 44%, while the percentage of hospital- or corporate-employed physicians increased between 13% and 24%.
Eighty percent of physicians in the Midwest are employed by hospitals or corporations, which leads the rest of the country, per the report. That’s followed by the Northeast, the West, and the South. Overall, the number of physicians working for such entities increased in all regions.
The report revealed that physician employment by corporations such as health insurers and venture capital firms grew from 92,400 in January 2019 to 142,900 in January 2022.
Hospitals and corporate entities acquired 36,200 physician practices (representing 38% growth) between 2019 and 2021, and the majority of these moves occurred since the pandemic’s start, according to the report.
Value-based care, venture capital firms driving change
Ms. Kenney pointed to value-based care as driving much of this activity by hospitals. “We all embrace [value-based payment], because we need to get a handle on cost, and we want better quality [but] those trends tend to favor integrated systems and systems that can handle a lot of risk and populations of patients.”
Still, the moves by private equity firms and health insurers in this space is relatively new, said Ms. Kenney, who added that her organization started tracking this trend 3 years ago. She pointed to a “marked acceleration” in the trend toward employing physicians and the sale of practices in the 18 months following the pandemic’s start; nonhospital corporate entities drove that steep increase, she said.
Ms. Kenney calls for further study and “guardrails” to respond to “that force in the health care system,” referring to the acquisition of practices by entities such as private equity firms. “Are these big [health care] systems going to continue to see patients in underserved areas, rural areas, and Medicaid patients if it doesn’t make sense financially to do so?
“That’s what we’re teeing up with this research,” added Ms. Kenney. “We are providing information that starts some conversations around what we might want to think about in terms of policies to ensure that we don’t impact patients’ access to care.”
The Physicians Advocacy Institute represents more than 170,000 physicians and medical students. Avalere Health used the IQVIA OneKey database for the report. The researchers studied the 3-year period from Jan. 1, 2019, to Jan. 1, 2022.
A version of this article first appeared on Medscape.com.
Wearable sensors deemed reliable for home gait assessment in knee OA
Remote gait assessment in people with knee osteoarthritis using wearable sensors appears reliable but yields results slightly different from those achieved in the laboratory, researchers from Boston University have found.
As reported at the OARSI 2022 World Congress, there was “good to excellent reliability” in repeated measures collected by patients at home while being instructed via video teleconferencing.
Agreement was “moderate to excellent” when the findings were compared with those recorded in the lab, Michael J. Rose of Boston University reported at the congress, sponsored by the Osteoarthritis Research Society International.
“People walked faster and stood up faster in the lab,” Mr. Rose said. “Later we found that the difference in gait speed was statistically significant between the lab and home environment.”
This has been suggested previously and implies that data collected at home may have “greater ecological validity,” he observed.
Accelerated adoption of telehealth
Assessing how well someone walks or can stand from a seated position are well known and important assessments in knee OA, but these have but have traditionally only been done in large and expensive gait labs, Mr. Rose said.
Wearable technologies, such as the ones used in the study he presented, could help move these assessments out into the community. This is particularly timely considering the increased adoption of telehealth practices during the COVID-19 pandemic.
To look at the reliability measurements obtained via wearable sensors versus lab assessments, Mr. Rose and associates set up a substudy within a larger ongoing, single-arm trial looking at the use of digital assessments to measure the efficacy of an exercise intervention in reducing knee pain and improving knee function.
For inclusion in the main trial (n = 60), and hence the substudy (n = 20), participants had to have physician-diagnosed knee OA, be 50 years of age or older, have a body mass index of 40 kg/m2 or lower, be able to walk at for a least 20 minutes, and have a score of three or higher on the Knee Injury and Osteoarthritis Outcome Score pain subscale for weight-bearing items.
Acceptance of in-lab versus home testing
The substudy participants (mean age, 70.5 years) all underwent in-person lab visits in which a wearable sensor was placed on each foot and one around the lower back and the participant asked to perform walking and chair stand tests. The latter involved standing from a seated position as quickly as possible without using the arms five times, while the former involved walking 28 meters in two laps of a 7-meter path defined by two cones. These tests were repeated twice.
Participants were then given the equipment to repeat these tests at home; this included the three sensors, a tablet computer, and chair and cones. The home assessments were conducted via video conferencing, with the researchers reminding how to place the sensors correctly. The walking and chair stand tests were then each performed four times: Twice in a row and then a 15-minute rest period before being performed twice in a row again.
The researchers collected participants’ feedback about the process on questionnaires and Likert scales that showed an overall positive experience for the remote home visit, with the median rating being “very likely” to participate in another home visit and that the time commitment required was “very manageable.”
Good correlation found
To determine the correlation and the test-retest reliability of the data obtained during the repeated home tasks, Mr. Rose and collaborators used Pearson’s correlation R2 and the intra-class correlation coefficients (ICC).
ICCs for various gait and chair stand variables obtained with the sensors were between 0.85 and 0.96 for the test-retest reliability during the remote home visit, and R2 ranged between 0.81 and 0.95. Variables include stance, cadence (steps per minute), step duration and length, speed, and chair stand duration.
With regard to the agreement between the home versus lab results, ICCs ranged between 0.63 and 0.9.
“There were some logistical and technological challenges with the approach,” Mr. Rose conceded. “Despite written and verbal instructions, 2 of the 20 participants ended up having gait data that was unusable in the home visit.”
Another limitation is that the study population, while “representative,” contained a higher number of individuals than the general population who identified as being White (95%) and female (85%), and 90% had a college degree.
“Individuals typically representative of an OA population were generally accepting and willing to participate in remote visits showing the feasibility of our approach,” Mr. Rose said.
“We need to determine the responsiveness of gait and chair stand outcomes from wearable sensors at home to change over time.”
The study was sponsored by Boston University with funding from Pfizer and Eli Lilly. The researchers used the OPAL inertial sensor (APDM Wearable Technologies) in the study. Mr. Rose made no personal disclosures. Four of his collaborators were employees of Pfizer and one is an employee of Eli Lilly & Company, all with stock or stock options.
Remote gait assessment in people with knee osteoarthritis using wearable sensors appears reliable but yields results slightly different from those achieved in the laboratory, researchers from Boston University have found.
As reported at the OARSI 2022 World Congress, there was “good to excellent reliability” in repeated measures collected by patients at home while being instructed via video teleconferencing.
Agreement was “moderate to excellent” when the findings were compared with those recorded in the lab, Michael J. Rose of Boston University reported at the congress, sponsored by the Osteoarthritis Research Society International.
“People walked faster and stood up faster in the lab,” Mr. Rose said. “Later we found that the difference in gait speed was statistically significant between the lab and home environment.”
This has been suggested previously and implies that data collected at home may have “greater ecological validity,” he observed.
Accelerated adoption of telehealth
Assessing how well someone walks or can stand from a seated position are well known and important assessments in knee OA, but these have but have traditionally only been done in large and expensive gait labs, Mr. Rose said.
Wearable technologies, such as the ones used in the study he presented, could help move these assessments out into the community. This is particularly timely considering the increased adoption of telehealth practices during the COVID-19 pandemic.
To look at the reliability measurements obtained via wearable sensors versus lab assessments, Mr. Rose and associates set up a substudy within a larger ongoing, single-arm trial looking at the use of digital assessments to measure the efficacy of an exercise intervention in reducing knee pain and improving knee function.
For inclusion in the main trial (n = 60), and hence the substudy (n = 20), participants had to have physician-diagnosed knee OA, be 50 years of age or older, have a body mass index of 40 kg/m2 or lower, be able to walk at for a least 20 minutes, and have a score of three or higher on the Knee Injury and Osteoarthritis Outcome Score pain subscale for weight-bearing items.
Acceptance of in-lab versus home testing
The substudy participants (mean age, 70.5 years) all underwent in-person lab visits in which a wearable sensor was placed on each foot and one around the lower back and the participant asked to perform walking and chair stand tests. The latter involved standing from a seated position as quickly as possible without using the arms five times, while the former involved walking 28 meters in two laps of a 7-meter path defined by two cones. These tests were repeated twice.
Participants were then given the equipment to repeat these tests at home; this included the three sensors, a tablet computer, and chair and cones. The home assessments were conducted via video conferencing, with the researchers reminding how to place the sensors correctly. The walking and chair stand tests were then each performed four times: Twice in a row and then a 15-minute rest period before being performed twice in a row again.
The researchers collected participants’ feedback about the process on questionnaires and Likert scales that showed an overall positive experience for the remote home visit, with the median rating being “very likely” to participate in another home visit and that the time commitment required was “very manageable.”
Good correlation found
To determine the correlation and the test-retest reliability of the data obtained during the repeated home tasks, Mr. Rose and collaborators used Pearson’s correlation R2 and the intra-class correlation coefficients (ICC).
ICCs for various gait and chair stand variables obtained with the sensors were between 0.85 and 0.96 for the test-retest reliability during the remote home visit, and R2 ranged between 0.81 and 0.95. Variables include stance, cadence (steps per minute), step duration and length, speed, and chair stand duration.
With regard to the agreement between the home versus lab results, ICCs ranged between 0.63 and 0.9.
“There were some logistical and technological challenges with the approach,” Mr. Rose conceded. “Despite written and verbal instructions, 2 of the 20 participants ended up having gait data that was unusable in the home visit.”
Another limitation is that the study population, while “representative,” contained a higher number of individuals than the general population who identified as being White (95%) and female (85%), and 90% had a college degree.
“Individuals typically representative of an OA population were generally accepting and willing to participate in remote visits showing the feasibility of our approach,” Mr. Rose said.
“We need to determine the responsiveness of gait and chair stand outcomes from wearable sensors at home to change over time.”
The study was sponsored by Boston University with funding from Pfizer and Eli Lilly. The researchers used the OPAL inertial sensor (APDM Wearable Technologies) in the study. Mr. Rose made no personal disclosures. Four of his collaborators were employees of Pfizer and one is an employee of Eli Lilly & Company, all with stock or stock options.
Remote gait assessment in people with knee osteoarthritis using wearable sensors appears reliable but yields results slightly different from those achieved in the laboratory, researchers from Boston University have found.
As reported at the OARSI 2022 World Congress, there was “good to excellent reliability” in repeated measures collected by patients at home while being instructed via video teleconferencing.
Agreement was “moderate to excellent” when the findings were compared with those recorded in the lab, Michael J. Rose of Boston University reported at the congress, sponsored by the Osteoarthritis Research Society International.
“People walked faster and stood up faster in the lab,” Mr. Rose said. “Later we found that the difference in gait speed was statistically significant between the lab and home environment.”
This has been suggested previously and implies that data collected at home may have “greater ecological validity,” he observed.
Accelerated adoption of telehealth
Assessing how well someone walks or can stand from a seated position are well known and important assessments in knee OA, but these have but have traditionally only been done in large and expensive gait labs, Mr. Rose said.
Wearable technologies, such as the ones used in the study he presented, could help move these assessments out into the community. This is particularly timely considering the increased adoption of telehealth practices during the COVID-19 pandemic.
To look at the reliability measurements obtained via wearable sensors versus lab assessments, Mr. Rose and associates set up a substudy within a larger ongoing, single-arm trial looking at the use of digital assessments to measure the efficacy of an exercise intervention in reducing knee pain and improving knee function.
For inclusion in the main trial (n = 60), and hence the substudy (n = 20), participants had to have physician-diagnosed knee OA, be 50 years of age or older, have a body mass index of 40 kg/m2 or lower, be able to walk at for a least 20 minutes, and have a score of three or higher on the Knee Injury and Osteoarthritis Outcome Score pain subscale for weight-bearing items.
Acceptance of in-lab versus home testing
The substudy participants (mean age, 70.5 years) all underwent in-person lab visits in which a wearable sensor was placed on each foot and one around the lower back and the participant asked to perform walking and chair stand tests. The latter involved standing from a seated position as quickly as possible without using the arms five times, while the former involved walking 28 meters in two laps of a 7-meter path defined by two cones. These tests were repeated twice.
Participants were then given the equipment to repeat these tests at home; this included the three sensors, a tablet computer, and chair and cones. The home assessments were conducted via video conferencing, with the researchers reminding how to place the sensors correctly. The walking and chair stand tests were then each performed four times: Twice in a row and then a 15-minute rest period before being performed twice in a row again.
The researchers collected participants’ feedback about the process on questionnaires and Likert scales that showed an overall positive experience for the remote home visit, with the median rating being “very likely” to participate in another home visit and that the time commitment required was “very manageable.”
Good correlation found
To determine the correlation and the test-retest reliability of the data obtained during the repeated home tasks, Mr. Rose and collaborators used Pearson’s correlation R2 and the intra-class correlation coefficients (ICC).
ICCs for various gait and chair stand variables obtained with the sensors were between 0.85 and 0.96 for the test-retest reliability during the remote home visit, and R2 ranged between 0.81 and 0.95. Variables include stance, cadence (steps per minute), step duration and length, speed, and chair stand duration.
With regard to the agreement between the home versus lab results, ICCs ranged between 0.63 and 0.9.
“There were some logistical and technological challenges with the approach,” Mr. Rose conceded. “Despite written and verbal instructions, 2 of the 20 participants ended up having gait data that was unusable in the home visit.”
Another limitation is that the study population, while “representative,” contained a higher number of individuals than the general population who identified as being White (95%) and female (85%), and 90% had a college degree.
“Individuals typically representative of an OA population were generally accepting and willing to participate in remote visits showing the feasibility of our approach,” Mr. Rose said.
“We need to determine the responsiveness of gait and chair stand outcomes from wearable sensors at home to change over time.”
The study was sponsored by Boston University with funding from Pfizer and Eli Lilly. The researchers used the OPAL inertial sensor (APDM Wearable Technologies) in the study. Mr. Rose made no personal disclosures. Four of his collaborators were employees of Pfizer and one is an employee of Eli Lilly & Company, all with stock or stock options.
FROM OARSI 2022
Myocarditis higher with Moderna COVID vax in young men
One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.
The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.
The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.
By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.
The study was published online in JAMA Cardiology.
The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.
For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.
“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.
“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.
“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.
After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.
The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.
Risk higher with vaccination than infection?
For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.
Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.
Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.
“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”
The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.
“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.
The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.
“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.
Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions.
But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.
Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.
What to advise patients?
In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.
They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.
They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.
“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.
But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.
The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.
“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.
Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.
A version of this article first appeared on Medscape.com.
One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.
The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.
The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.
By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.
The study was published online in JAMA Cardiology.
The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.
For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.
“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.
“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.
“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.
After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.
The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.
Risk higher with vaccination than infection?
For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.
Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.
Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.
“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”
The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.
“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.
The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.
“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.
Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions.
But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.
Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.
What to advise patients?
In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.
They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.
They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.
“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.
But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.
The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.
“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.
Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.
A version of this article first appeared on Medscape.com.
One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.
The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.
The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.
By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.
The study was published online in JAMA Cardiology.
The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.
For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.
“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.
“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.
“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.
After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.
The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.
Risk higher with vaccination than infection?
For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.
Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.
Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.
“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”
The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.
“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.
The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.
“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.
Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions.
But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.
Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.
What to advise patients?
In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.
They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.
They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.
“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.
But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.
The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.
“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.
Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.
A version of this article first appeared on Medscape.com.
FROM JAMA CARDIOLOGY
TNF inhibitors prior to surgery safe in patients with IBD: Study
Patients with inflammatory bowel disease (IBD) can safely take tumor necrosis factor inhibitors (TNFi) prior to abdominal surgery, a prospective, multicenter, observational study confirms.
The researchers found that exposure to TNFi in the 12 weeks prior to surgery was not associated with an increased risk of either overall infections or surgical site infections (SSI).
The findings should be “very reassuring” for clinicians, lead author Benjamin L. Cohen, MD, Cleveland Clinic Foundation, told this news organization. “In the past, when clinicians were unsure about the safety of using these drugs in the perioperative period, they may have delayed surgeries or stopped medications unnecessarily.”
“For me, the key take-home point of this study is that we need to plan the timing and management of medications around surgery based on factors other than the use of tumor necrosis factor inhibitors in most patients,” Dr. Cohen continued.
Ultimately, “we will help change practice in how we manage patients with IBD having surgery,” he said.
The research was published online in Gastroenterology.
No increased postop infection risk
The Prospective Cohort of Ulcerative Colitis and Crohn’s Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I (PUCCINI) trial enrolled patients with IBD from 17 sites participating in the Crohn’s and Colitis Foundation Clinical Research Alliance between September 2014 and June 2017.
Patients had Crohn’s disease, ulcerative colitis, or indeterminate colitis, as determined by standard criteria, and planned to undergo intra-abdominal surgery or had undergone intra-abdominal surgery in the preceding 4 days.
Among the 947 patients enrolled, 47.8% were women. All were aged 18 years or older. The median disease duration was 10 years; 34.4% of patients had undergone prior bowel resection, and a further 17.5% had undergone other abdominal surgery.
Systemic corticosteroid use within 2 weeks of surgery was reported by 40.9% of patients, and 42.3% had used antibiotics.
TNFi exposure within the 12 weeks prior to surgery was reported by 40.3% of patients. Adalimumab and infliximab were the most commonly used drugs. Among those who had not used TNFi prior to surgery, 23.7% were TNFi-naive, and 36.0% had used them in the past.
The researchers report that there was no significant difference in the rate of postoperative infections between patients who reported using TNFi in the 12 weeks prior to surgery and those who did not (18.1% vs. 20.2%; P = .469). There was also no difference in SSI, as defined using the Centers for Disease Control and Prevention criteria, between the two groups (12.0% vs 12.6%; P = .889).
Multivariate analysis revealed that current TNFi exposure was not associated with any infection, at an odds ratio versus no exposure of 1.050 (P = .80), or with SSI, at an odds ratio of 1.249 (P = .34).
In contrast, preoperative corticosteroid exposure, prior bowel resection, and current smoking were associated with any infection and with SSI.
Approached for comment, Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, said that the current findings are consistent with those of previous studies and that their relevance extends beyond abdominal surgery.
In the past, when surgeons were “confronted with a patient on a TNF blocker, even if it’s orthopedic or plastic surgery, they recommended against using a TNF blocker or operating at the end of the cycle when the drug levels are low,” he told this news organization.
Dr. Hanauer said such practice gets clinicians into a “bind because you’ve got a patient, for instance, who’s got a blockage with Crohn’s disease ... but the only way you could manage them when the TNFi was out of their system was with steroids, which is worse” in terms of postoperative infection risk, he explained.
Prospective studies important
The researchers note that up to 50% of patients with IBD are exposed to TNFi prior to their first surgery. They also note that there is concern that preoperative treatment with these and other immunosuppressive medications may increase the risk of postoperative infections.
However, the evidence is inconsistent, they write, so whether to continue or stop the drugs prior to surgery remains controversial.
“A lot of the initial studies in the perioperative population were single-center and retrospective for the most part,” Dr. Cohen said, adding that the studies used different modes of assessment and followed different time frames.
“So, there’s a lot of heterogeneity,” he said.
In addition, early studies of TNFi were often conducted with patients who were very ill and who had started receiving the drug right before surgery, and they sometimes had a complication Dr. Cohen said. “But you don’t know if that’s because of the drug itself or because of many other factors associated with them being very sick, such as being on steroids, being very malnourished, or having other complications of disease.”
It is difficult to control for such risk factors in retrospective analyses because the information is not always available from medical records, he said. “That’s why it’s so important to study clinical questions like this in a prospective manner.”
Dr. Cohen added that it is important that studies such as theirs continue to be undertaken as new drugs become available.
“We’re entering an era of rapidly expanding drug discovery, so we’re going to have new medications available for use in our patients with IBD,” he explained. “It’s important that we continue to build prospective cohorts to look at questions such as the safety of medications in the perioperative period, rather than solely relying on retrospective data.”
The study was funded by a Crohn’s & Colitis Foundation Senior Research Award. Dr. Cohen reports relationships with AbbVie, Celgene, Bristol-Myers Squibb, Pfizer, Sublimity Therapeutics, Target RWE, Janssen, Ferring, AlphaSigma, and Takeda. Other authors report numerous financial relationships. Dr. Hanauer reports relationships with Janssen, AbbVie, Pfizer, Amgen, Genentech, and Merck.
A version of this article first appeared on Medscape.com.
Patients with inflammatory bowel disease (IBD) can safely take tumor necrosis factor inhibitors (TNFi) prior to abdominal surgery, a prospective, multicenter, observational study confirms.
The researchers found that exposure to TNFi in the 12 weeks prior to surgery was not associated with an increased risk of either overall infections or surgical site infections (SSI).
The findings should be “very reassuring” for clinicians, lead author Benjamin L. Cohen, MD, Cleveland Clinic Foundation, told this news organization. “In the past, when clinicians were unsure about the safety of using these drugs in the perioperative period, they may have delayed surgeries or stopped medications unnecessarily.”
“For me, the key take-home point of this study is that we need to plan the timing and management of medications around surgery based on factors other than the use of tumor necrosis factor inhibitors in most patients,” Dr. Cohen continued.
Ultimately, “we will help change practice in how we manage patients with IBD having surgery,” he said.
The research was published online in Gastroenterology.
No increased postop infection risk
The Prospective Cohort of Ulcerative Colitis and Crohn’s Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I (PUCCINI) trial enrolled patients with IBD from 17 sites participating in the Crohn’s and Colitis Foundation Clinical Research Alliance between September 2014 and June 2017.
Patients had Crohn’s disease, ulcerative colitis, or indeterminate colitis, as determined by standard criteria, and planned to undergo intra-abdominal surgery or had undergone intra-abdominal surgery in the preceding 4 days.
Among the 947 patients enrolled, 47.8% were women. All were aged 18 years or older. The median disease duration was 10 years; 34.4% of patients had undergone prior bowel resection, and a further 17.5% had undergone other abdominal surgery.
Systemic corticosteroid use within 2 weeks of surgery was reported by 40.9% of patients, and 42.3% had used antibiotics.
TNFi exposure within the 12 weeks prior to surgery was reported by 40.3% of patients. Adalimumab and infliximab were the most commonly used drugs. Among those who had not used TNFi prior to surgery, 23.7% were TNFi-naive, and 36.0% had used them in the past.
The researchers report that there was no significant difference in the rate of postoperative infections between patients who reported using TNFi in the 12 weeks prior to surgery and those who did not (18.1% vs. 20.2%; P = .469). There was also no difference in SSI, as defined using the Centers for Disease Control and Prevention criteria, between the two groups (12.0% vs 12.6%; P = .889).
Multivariate analysis revealed that current TNFi exposure was not associated with any infection, at an odds ratio versus no exposure of 1.050 (P = .80), or with SSI, at an odds ratio of 1.249 (P = .34).
In contrast, preoperative corticosteroid exposure, prior bowel resection, and current smoking were associated with any infection and with SSI.
Approached for comment, Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, said that the current findings are consistent with those of previous studies and that their relevance extends beyond abdominal surgery.
In the past, when surgeons were “confronted with a patient on a TNF blocker, even if it’s orthopedic or plastic surgery, they recommended against using a TNF blocker or operating at the end of the cycle when the drug levels are low,” he told this news organization.
Dr. Hanauer said such practice gets clinicians into a “bind because you’ve got a patient, for instance, who’s got a blockage with Crohn’s disease ... but the only way you could manage them when the TNFi was out of their system was with steroids, which is worse” in terms of postoperative infection risk, he explained.
Prospective studies important
The researchers note that up to 50% of patients with IBD are exposed to TNFi prior to their first surgery. They also note that there is concern that preoperative treatment with these and other immunosuppressive medications may increase the risk of postoperative infections.
However, the evidence is inconsistent, they write, so whether to continue or stop the drugs prior to surgery remains controversial.
“A lot of the initial studies in the perioperative population were single-center and retrospective for the most part,” Dr. Cohen said, adding that the studies used different modes of assessment and followed different time frames.
“So, there’s a lot of heterogeneity,” he said.
In addition, early studies of TNFi were often conducted with patients who were very ill and who had started receiving the drug right before surgery, and they sometimes had a complication Dr. Cohen said. “But you don’t know if that’s because of the drug itself or because of many other factors associated with them being very sick, such as being on steroids, being very malnourished, or having other complications of disease.”
It is difficult to control for such risk factors in retrospective analyses because the information is not always available from medical records, he said. “That’s why it’s so important to study clinical questions like this in a prospective manner.”
Dr. Cohen added that it is important that studies such as theirs continue to be undertaken as new drugs become available.
“We’re entering an era of rapidly expanding drug discovery, so we’re going to have new medications available for use in our patients with IBD,” he explained. “It’s important that we continue to build prospective cohorts to look at questions such as the safety of medications in the perioperative period, rather than solely relying on retrospective data.”
The study was funded by a Crohn’s & Colitis Foundation Senior Research Award. Dr. Cohen reports relationships with AbbVie, Celgene, Bristol-Myers Squibb, Pfizer, Sublimity Therapeutics, Target RWE, Janssen, Ferring, AlphaSigma, and Takeda. Other authors report numerous financial relationships. Dr. Hanauer reports relationships with Janssen, AbbVie, Pfizer, Amgen, Genentech, and Merck.
A version of this article first appeared on Medscape.com.
Patients with inflammatory bowel disease (IBD) can safely take tumor necrosis factor inhibitors (TNFi) prior to abdominal surgery, a prospective, multicenter, observational study confirms.
The researchers found that exposure to TNFi in the 12 weeks prior to surgery was not associated with an increased risk of either overall infections or surgical site infections (SSI).
The findings should be “very reassuring” for clinicians, lead author Benjamin L. Cohen, MD, Cleveland Clinic Foundation, told this news organization. “In the past, when clinicians were unsure about the safety of using these drugs in the perioperative period, they may have delayed surgeries or stopped medications unnecessarily.”
“For me, the key take-home point of this study is that we need to plan the timing and management of medications around surgery based on factors other than the use of tumor necrosis factor inhibitors in most patients,” Dr. Cohen continued.
Ultimately, “we will help change practice in how we manage patients with IBD having surgery,” he said.
The research was published online in Gastroenterology.
No increased postop infection risk
The Prospective Cohort of Ulcerative Colitis and Crohn’s Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I (PUCCINI) trial enrolled patients with IBD from 17 sites participating in the Crohn’s and Colitis Foundation Clinical Research Alliance between September 2014 and June 2017.
Patients had Crohn’s disease, ulcerative colitis, or indeterminate colitis, as determined by standard criteria, and planned to undergo intra-abdominal surgery or had undergone intra-abdominal surgery in the preceding 4 days.
Among the 947 patients enrolled, 47.8% were women. All were aged 18 years or older. The median disease duration was 10 years; 34.4% of patients had undergone prior bowel resection, and a further 17.5% had undergone other abdominal surgery.
Systemic corticosteroid use within 2 weeks of surgery was reported by 40.9% of patients, and 42.3% had used antibiotics.
TNFi exposure within the 12 weeks prior to surgery was reported by 40.3% of patients. Adalimumab and infliximab were the most commonly used drugs. Among those who had not used TNFi prior to surgery, 23.7% were TNFi-naive, and 36.0% had used them in the past.
The researchers report that there was no significant difference in the rate of postoperative infections between patients who reported using TNFi in the 12 weeks prior to surgery and those who did not (18.1% vs. 20.2%; P = .469). There was also no difference in SSI, as defined using the Centers for Disease Control and Prevention criteria, between the two groups (12.0% vs 12.6%; P = .889).
Multivariate analysis revealed that current TNFi exposure was not associated with any infection, at an odds ratio versus no exposure of 1.050 (P = .80), or with SSI, at an odds ratio of 1.249 (P = .34).
In contrast, preoperative corticosteroid exposure, prior bowel resection, and current smoking were associated with any infection and with SSI.
Approached for comment, Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern University, Chicago, said that the current findings are consistent with those of previous studies and that their relevance extends beyond abdominal surgery.
In the past, when surgeons were “confronted with a patient on a TNF blocker, even if it’s orthopedic or plastic surgery, they recommended against using a TNF blocker or operating at the end of the cycle when the drug levels are low,” he told this news organization.
Dr. Hanauer said such practice gets clinicians into a “bind because you’ve got a patient, for instance, who’s got a blockage with Crohn’s disease ... but the only way you could manage them when the TNFi was out of their system was with steroids, which is worse” in terms of postoperative infection risk, he explained.
Prospective studies important
The researchers note that up to 50% of patients with IBD are exposed to TNFi prior to their first surgery. They also note that there is concern that preoperative treatment with these and other immunosuppressive medications may increase the risk of postoperative infections.
However, the evidence is inconsistent, they write, so whether to continue or stop the drugs prior to surgery remains controversial.
“A lot of the initial studies in the perioperative population were single-center and retrospective for the most part,” Dr. Cohen said, adding that the studies used different modes of assessment and followed different time frames.
“So, there’s a lot of heterogeneity,” he said.
In addition, early studies of TNFi were often conducted with patients who were very ill and who had started receiving the drug right before surgery, and they sometimes had a complication Dr. Cohen said. “But you don’t know if that’s because of the drug itself or because of many other factors associated with them being very sick, such as being on steroids, being very malnourished, or having other complications of disease.”
It is difficult to control for such risk factors in retrospective analyses because the information is not always available from medical records, he said. “That’s why it’s so important to study clinical questions like this in a prospective manner.”
Dr. Cohen added that it is important that studies such as theirs continue to be undertaken as new drugs become available.
“We’re entering an era of rapidly expanding drug discovery, so we’re going to have new medications available for use in our patients with IBD,” he explained. “It’s important that we continue to build prospective cohorts to look at questions such as the safety of medications in the perioperative period, rather than solely relying on retrospective data.”
The study was funded by a Crohn’s & Colitis Foundation Senior Research Award. Dr. Cohen reports relationships with AbbVie, Celgene, Bristol-Myers Squibb, Pfizer, Sublimity Therapeutics, Target RWE, Janssen, Ferring, AlphaSigma, and Takeda. Other authors report numerous financial relationships. Dr. Hanauer reports relationships with Janssen, AbbVie, Pfizer, Amgen, Genentech, and Merck.
A version of this article first appeared on Medscape.com.
FROM GASTROENTEROLOGY
Breast anatomy and augmentation in transfeminine individuals
Augmentation mammaplasty, otherwise known as a breast augmentation, is one of the most common cosmetic procedures performed in cisgender females. Gynecologists routinely perform annual breast examinations and order screening mammography in cisgender women with breast implants. Similarly, there is an increasing number of transgender women seeking breast augmentation – with approximately 60%-70% of patients having desired or undergone the procedure.1 Consequently, these patients are instructed by their surgeons to follow up with gynecologists for annual examinations and screening. While there are many similarities in technique and procedure, there are nuances in patient demographics, anatomy, and surgical technique that obstetricians/gynecologists should be aware of when examining these patients or prior to referring them to a surgeon for augmentation.2
Many patients who are dissatisfied with breast size from hormone therapy alone will seek out augmentation mammaplasty. In patients taking estrogen for hormone therapy, breast growth will commence around 2-3 months and peak over 1-2 years.3 Unlike chest surgery for transmasculine individuals, it is recommended that transfeminine patients seeking breast augmentation wait a minimum of 12 months before to surgery to allow for maximum breast enlargement. As with breast growth in cisgender females, the extent of breast development is multifactorial and varies from individual to individual. Current literature does not suggest that estrogen type or dose affects the ultimate breast size; however, younger age, tissue sensitivity, and body weight may affect breast volume.3 Referral to a genetic counselor and preoperative imaging may be necessary if a patient has a history concerning for a genetic or familial predisposition to breast cancer.
Implant selection and placement is determined by a variety of factors. While the overall principles of augmentation mammaplasty are essentially the same, there are anatomic differences in transfeminine patients that surgeons must take into consideration at the time of the consultation and during the surgery itself. For example, the pectoralis major muscle is more defined, there is a longer sternal notch-to-nipple distance, the chest wall is broader and more barrel-shaped, and there is a shorter distance between the nipple and the inframammary crease.2-4 As a result of the broader chest wall, it is extremely difficult to achieve central cleavage even with larger implant selection. The surgeon must also ensure that the nipple and areola overlie the implant centrally. Medial placement of the implant will result in lateral displacement of the nipples, which can have an unsatisfactory cosmetic appearance.
Incision location can be axillary, inframammary, or even transareolar, although the latter is less common due to the smaller areolar size and larger implant choice.3 If the inframammary incision is used, it should be placed lower than the natural inframammary fold because the distance between the inferior areolar margin and inframammary fold is shorter and will expand after the implant is placed.4 While both saline and silicone implants are available, many surgeons (myself included), favor more form-stable silicone implants. Given the association between anaplastic large-cell lymphoma and textured implants, many surgeons also use nontextured, or smooth, cohesive gel silicone implants.5
Pocket selection of the implant itself can be subglandular – directly under the breast mound – or subpectoral – behind the pectoralis muscle. For patients with a pinch test of greater than 1.5 cm (outside of the area of the breast bud), good skin softening, and marked pectoralis hypertrophy, subglandular placement is reasonable.6 In thin patients with minimal breast development, subglandular placement can result in a “double-mound” appearance and can lead to visible implant edges on the periphery.6 Use of the subpectoral plane is more common and is associated with less implant visibility due to an increased amount of soft-tissue coverage and has lower rates of capsular contracture.4 However, due to the more robust pectoralis muscle in transfeminine patients, implant displacement can occur more frequently compared to subglandular placement. The surgeon and patient must have a thorough discussion about the location of the incision, implant material, and pocket placement along with the benefits and complications of the surgical plan.
Complications of augmentation mammaplasty are rare. However, when they occur it can include capsular contracture, breast asymmetry, hematoma formation, loss of nipple sensation, implant malposition, implant displacement below the inframammary crease, implant rupture, and need for revisional surgery.7 If an obstetrician/gynecologist observes any of the aforementioned findings in a postoperative patient, consultation and referral to a plastic surgeon is imperative.
Postoperative assessment and screening are mandatory in all patients who undergo breast augmentation. It is important for the gynecologist to note the incision placement, know the type of implant used (saline or silicone), and delineate where the implant was placed. If silicone implants are used, breast MRI is more sensitive in detecting implant rupture compared to mammography alone. Given the relatively poor epidemiologic data on breast cancer in transgender women, the Endocrine Society recommends that these patients follow the same screening guidelines as cisgender women.4,6
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Wierckx K et al. J Sex Med. 2014;11(5):1240-7.
2. Mehra G et al. Plast Reconstr Surg Glob Open 2021 Jan 21;9(1):e3362. doi: 10.1097/GOX.0000000000003362.
3. Schecter LS, Schechter RB. Breast and chest surgery for transgender patients. In: Ferrando CA, ed. Comprehensive Care of the Transgender Patient. Philadelphia, PA: Elsevier, 2020:73-81.
4. Colebunders B et al. Top surgery. In: Salgado CJ et al. ed. Gender Affirmation: Medical and Surgical Perspectives. New York, NY: Thieme, 2017:51-66.
5. De Boer M et al. Aesthet Surg J. 2017;37:NP83-NP87.
6. Coon D et al. Plast Reconstr Surg. 2020 Jun;145(6):1343-53.
7. Kanhai RC et al. Br J Plast Surg. 2000;53:209-11.
Augmentation mammaplasty, otherwise known as a breast augmentation, is one of the most common cosmetic procedures performed in cisgender females. Gynecologists routinely perform annual breast examinations and order screening mammography in cisgender women with breast implants. Similarly, there is an increasing number of transgender women seeking breast augmentation – with approximately 60%-70% of patients having desired or undergone the procedure.1 Consequently, these patients are instructed by their surgeons to follow up with gynecologists for annual examinations and screening. While there are many similarities in technique and procedure, there are nuances in patient demographics, anatomy, and surgical technique that obstetricians/gynecologists should be aware of when examining these patients or prior to referring them to a surgeon for augmentation.2
Many patients who are dissatisfied with breast size from hormone therapy alone will seek out augmentation mammaplasty. In patients taking estrogen for hormone therapy, breast growth will commence around 2-3 months and peak over 1-2 years.3 Unlike chest surgery for transmasculine individuals, it is recommended that transfeminine patients seeking breast augmentation wait a minimum of 12 months before to surgery to allow for maximum breast enlargement. As with breast growth in cisgender females, the extent of breast development is multifactorial and varies from individual to individual. Current literature does not suggest that estrogen type or dose affects the ultimate breast size; however, younger age, tissue sensitivity, and body weight may affect breast volume.3 Referral to a genetic counselor and preoperative imaging may be necessary if a patient has a history concerning for a genetic or familial predisposition to breast cancer.
Implant selection and placement is determined by a variety of factors. While the overall principles of augmentation mammaplasty are essentially the same, there are anatomic differences in transfeminine patients that surgeons must take into consideration at the time of the consultation and during the surgery itself. For example, the pectoralis major muscle is more defined, there is a longer sternal notch-to-nipple distance, the chest wall is broader and more barrel-shaped, and there is a shorter distance between the nipple and the inframammary crease.2-4 As a result of the broader chest wall, it is extremely difficult to achieve central cleavage even with larger implant selection. The surgeon must also ensure that the nipple and areola overlie the implant centrally. Medial placement of the implant will result in lateral displacement of the nipples, which can have an unsatisfactory cosmetic appearance.
Incision location can be axillary, inframammary, or even transareolar, although the latter is less common due to the smaller areolar size and larger implant choice.3 If the inframammary incision is used, it should be placed lower than the natural inframammary fold because the distance between the inferior areolar margin and inframammary fold is shorter and will expand after the implant is placed.4 While both saline and silicone implants are available, many surgeons (myself included), favor more form-stable silicone implants. Given the association between anaplastic large-cell lymphoma and textured implants, many surgeons also use nontextured, or smooth, cohesive gel silicone implants.5
Pocket selection of the implant itself can be subglandular – directly under the breast mound – or subpectoral – behind the pectoralis muscle. For patients with a pinch test of greater than 1.5 cm (outside of the area of the breast bud), good skin softening, and marked pectoralis hypertrophy, subglandular placement is reasonable.6 In thin patients with minimal breast development, subglandular placement can result in a “double-mound” appearance and can lead to visible implant edges on the periphery.6 Use of the subpectoral plane is more common and is associated with less implant visibility due to an increased amount of soft-tissue coverage and has lower rates of capsular contracture.4 However, due to the more robust pectoralis muscle in transfeminine patients, implant displacement can occur more frequently compared to subglandular placement. The surgeon and patient must have a thorough discussion about the location of the incision, implant material, and pocket placement along with the benefits and complications of the surgical plan.
Complications of augmentation mammaplasty are rare. However, when they occur it can include capsular contracture, breast asymmetry, hematoma formation, loss of nipple sensation, implant malposition, implant displacement below the inframammary crease, implant rupture, and need for revisional surgery.7 If an obstetrician/gynecologist observes any of the aforementioned findings in a postoperative patient, consultation and referral to a plastic surgeon is imperative.
Postoperative assessment and screening are mandatory in all patients who undergo breast augmentation. It is important for the gynecologist to note the incision placement, know the type of implant used (saline or silicone), and delineate where the implant was placed. If silicone implants are used, breast MRI is more sensitive in detecting implant rupture compared to mammography alone. Given the relatively poor epidemiologic data on breast cancer in transgender women, the Endocrine Society recommends that these patients follow the same screening guidelines as cisgender women.4,6
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Wierckx K et al. J Sex Med. 2014;11(5):1240-7.
2. Mehra G et al. Plast Reconstr Surg Glob Open 2021 Jan 21;9(1):e3362. doi: 10.1097/GOX.0000000000003362.
3. Schecter LS, Schechter RB. Breast and chest surgery for transgender patients. In: Ferrando CA, ed. Comprehensive Care of the Transgender Patient. Philadelphia, PA: Elsevier, 2020:73-81.
4. Colebunders B et al. Top surgery. In: Salgado CJ et al. ed. Gender Affirmation: Medical and Surgical Perspectives. New York, NY: Thieme, 2017:51-66.
5. De Boer M et al. Aesthet Surg J. 2017;37:NP83-NP87.
6. Coon D et al. Plast Reconstr Surg. 2020 Jun;145(6):1343-53.
7. Kanhai RC et al. Br J Plast Surg. 2000;53:209-11.
Augmentation mammaplasty, otherwise known as a breast augmentation, is one of the most common cosmetic procedures performed in cisgender females. Gynecologists routinely perform annual breast examinations and order screening mammography in cisgender women with breast implants. Similarly, there is an increasing number of transgender women seeking breast augmentation – with approximately 60%-70% of patients having desired or undergone the procedure.1 Consequently, these patients are instructed by their surgeons to follow up with gynecologists for annual examinations and screening. While there are many similarities in technique and procedure, there are nuances in patient demographics, anatomy, and surgical technique that obstetricians/gynecologists should be aware of when examining these patients or prior to referring them to a surgeon for augmentation.2
Many patients who are dissatisfied with breast size from hormone therapy alone will seek out augmentation mammaplasty. In patients taking estrogen for hormone therapy, breast growth will commence around 2-3 months and peak over 1-2 years.3 Unlike chest surgery for transmasculine individuals, it is recommended that transfeminine patients seeking breast augmentation wait a minimum of 12 months before to surgery to allow for maximum breast enlargement. As with breast growth in cisgender females, the extent of breast development is multifactorial and varies from individual to individual. Current literature does not suggest that estrogen type or dose affects the ultimate breast size; however, younger age, tissue sensitivity, and body weight may affect breast volume.3 Referral to a genetic counselor and preoperative imaging may be necessary if a patient has a history concerning for a genetic or familial predisposition to breast cancer.
Implant selection and placement is determined by a variety of factors. While the overall principles of augmentation mammaplasty are essentially the same, there are anatomic differences in transfeminine patients that surgeons must take into consideration at the time of the consultation and during the surgery itself. For example, the pectoralis major muscle is more defined, there is a longer sternal notch-to-nipple distance, the chest wall is broader and more barrel-shaped, and there is a shorter distance between the nipple and the inframammary crease.2-4 As a result of the broader chest wall, it is extremely difficult to achieve central cleavage even with larger implant selection. The surgeon must also ensure that the nipple and areola overlie the implant centrally. Medial placement of the implant will result in lateral displacement of the nipples, which can have an unsatisfactory cosmetic appearance.
Incision location can be axillary, inframammary, or even transareolar, although the latter is less common due to the smaller areolar size and larger implant choice.3 If the inframammary incision is used, it should be placed lower than the natural inframammary fold because the distance between the inferior areolar margin and inframammary fold is shorter and will expand after the implant is placed.4 While both saline and silicone implants are available, many surgeons (myself included), favor more form-stable silicone implants. Given the association between anaplastic large-cell lymphoma and textured implants, many surgeons also use nontextured, or smooth, cohesive gel silicone implants.5
Pocket selection of the implant itself can be subglandular – directly under the breast mound – or subpectoral – behind the pectoralis muscle. For patients with a pinch test of greater than 1.5 cm (outside of the area of the breast bud), good skin softening, and marked pectoralis hypertrophy, subglandular placement is reasonable.6 In thin patients with minimal breast development, subglandular placement can result in a “double-mound” appearance and can lead to visible implant edges on the periphery.6 Use of the subpectoral plane is more common and is associated with less implant visibility due to an increased amount of soft-tissue coverage and has lower rates of capsular contracture.4 However, due to the more robust pectoralis muscle in transfeminine patients, implant displacement can occur more frequently compared to subglandular placement. The surgeon and patient must have a thorough discussion about the location of the incision, implant material, and pocket placement along with the benefits and complications of the surgical plan.
Complications of augmentation mammaplasty are rare. However, when they occur it can include capsular contracture, breast asymmetry, hematoma formation, loss of nipple sensation, implant malposition, implant displacement below the inframammary crease, implant rupture, and need for revisional surgery.7 If an obstetrician/gynecologist observes any of the aforementioned findings in a postoperative patient, consultation and referral to a plastic surgeon is imperative.
Postoperative assessment and screening are mandatory in all patients who undergo breast augmentation. It is important for the gynecologist to note the incision placement, know the type of implant used (saline or silicone), and delineate where the implant was placed. If silicone implants are used, breast MRI is more sensitive in detecting implant rupture compared to mammography alone. Given the relatively poor epidemiologic data on breast cancer in transgender women, the Endocrine Society recommends that these patients follow the same screening guidelines as cisgender women.4,6
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Wierckx K et al. J Sex Med. 2014;11(5):1240-7.
2. Mehra G et al. Plast Reconstr Surg Glob Open 2021 Jan 21;9(1):e3362. doi: 10.1097/GOX.0000000000003362.
3. Schecter LS, Schechter RB. Breast and chest surgery for transgender patients. In: Ferrando CA, ed. Comprehensive Care of the Transgender Patient. Philadelphia, PA: Elsevier, 2020:73-81.
4. Colebunders B et al. Top surgery. In: Salgado CJ et al. ed. Gender Affirmation: Medical and Surgical Perspectives. New York, NY: Thieme, 2017:51-66.
5. De Boer M et al. Aesthet Surg J. 2017;37:NP83-NP87.
6. Coon D et al. Plast Reconstr Surg. 2020 Jun;145(6):1343-53.
7. Kanhai RC et al. Br J Plast Surg. 2000;53:209-11.
Doc accused of killing 14 patients found not guilty
In an unprecedented murder case about end-of-life care, a physician accused of killing 14 critically ill patients with opioid overdoses in a Columbus, Ohio, hospital ICU over a period of 4 years was found not guilty by a jury April 20.
The jury, after a 7-week trial featuring more than 50 witnesses in the Franklin County Court of Common Pleas, declared William Husel, DO, not guilty on 14 counts of murder and attempted murder.
In a news conference after the verdict was announced, lead defense attorney Jose Baez said Dr. Husel, whom he called a “great doctor,” hopes to practice medicine again in the future. “They don’t need to be looking over their shoulders worrying about whether they’ll get charged with crimes,” he said.
The prosecutors in the case declined to comment, other than to say they “accept” the verdict.
Legal experts said it’s highly unlikely that Ohio or any other state would restore Dr. Husel’s suspended medical license. “I doubt he could ever work in medicine again,” said Mark Schumacher, a Columbus medical malpractice defense attorney who retired in 2020 after practicing for 39 years. Mr. Schumacher followed the trial closely.
The trial raised the specific issue of what constitutes a medically justifiable dose of opioid painkillers during the end-of-life procedure known as palliative extubation, in which critically ill patients are withdrawn from the ventilator when they are expected to die. Under medicine’s so-called double-effect principle, physicians must weigh the benefits and risks of ordering potentially lethal doses of painkillers and sedatives to provide comfort care for critically ill patients.
To many observers, however, the case really centered on the largely hidden debate over whether it’s acceptable to hasten the deaths of dying patients who haven’t chosen that path. That’s called euthanasia, which is illegal in the United States. In contrast, 10 states plus the District of Columbia allow physicians to prescribe lethal drugs to terminally ill, mentally competent adults who can self-administer them. That’s called medical aid in dying, or physician-assisted dying or suicide.
“Maybe this is a wake-up call that people believe this is the right thing to do,” said Lewis Nelson, MD, chair of emergency medicine at New Jersey Medical School in Newark. “The medical community has a sense that we often prolong life unnecessarily. But a physician cannot unilaterally decide it’s time for someone to die. It sounds like [Dr. Husel] took that decision into his own hands.”
The case also exposed major gaps in the patient safety culture at Mount Carmel West Hospital in Columbus, which is owned by the Catholic chain Trinity Health. Experts say failures by hospital staff to question physicians’ orders and raise patient safety concerns, as happened at Mount Carmel, occur at many hospitals around the country. Experts say the Husel case offers vital lessons for health care professionals about improving safety procedures.
“This is an extreme example, that everyone should learn from, about what not to do,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “Husel was giving massive overdoses of drugs, people knew it was problematic, and someone didn’t put their foot down. You’ve got to have a process in place to address these situations where there is disagreement over the safety of a medication order.”
Dr. Husel was charged with killing the 14 patients from 2015 through 2018 by ordering single large doses of the painkiller fentanyl – from 500 to 2,000 micrograms – often in combination with other opioids and sedatives, while working as the solo physician on the overnight shift in the ICU at Mount Carmel West Hospital and at Mount Carmel St. Ann’s Hospital in Westerville, Ohio.
Dr. Husel ordered administration of the drugs while his patients were having an endotracheal tube removed as part of palliative extubation. There was conflicting testimony during the trial about whether the patients were showing signs of pain or were even capable of feeling pain.
Prosecutors argued that Dr. Husel, who did a residency and fellowship in critical care medicine at Cleveland Clinic and started working at Mount Carmel in 2013 in his first job as a full-fledged physician, intended to kill the patients or hasten their deaths. They contended that the inexperienced nurses in the ICU went along with his large drug doses because they were “in thrall” to him because of his prestigious background at the Cleveland Clinic and his willingness to take the time to teach them.
“With his training in anesthesiology, he knew what those drugs do,” assistant prosecutor David Zeyen said in closing arguments. “This isn’t negligence. This is on purpose ... Euthanizing animals with the intent to kill is fine in veterinary medicine. It’s not fine in the ICU at Mount Carmel or anywhere.”
The defense team argued that Dr. Husel was a caring and compassionate physician who ordered the drugs to relieve the patients’ pain and discomfort during the extubation process. He did not testify.
“Common sense says Dr Husel had no motive to harm patients,” defense attorney Baez said in his closing. “He dedicated his life to taking care of patients and saving lives, not taking them. ... Why would this man risk his family, career, and 17 years of trying to be a doctor to hasten someone’s death or kill them?”
There were 35 Mount Carmel patients who died in the ICU under Dr. Husel’s care after receiving large fentanyl doses during palliative extubation. The state originally charged him with murder in 25 of those cases, then reduced that to 14.
Many of Dr. Husel’s drug orders were given verbally instead of through the regular process of being entered into the electronic health record. He and the nurses on duty also skipped the standard nonemergency process of getting approval from the pharmacist on duty, instead using the override function on Mount Carmel’s automated Pyxis drug dispensing system.
Dr. Husel’s unusual dosing patterns were first reported to Mount Carmel officials by pharmacists in October 2018, spurring an investigation. The hospital system let him go in December 2018, after concluding that the opioid dosages he used were “significantly excessive and potentially fatal” and “went beyond providing comfort.”
Nearly two dozen RNs and two pharmacists involved in these cases have faced state disciplinary action, mostly license suspension. Federal and state agencies have cited the Mount Carmel system for faults in its patient safety processes and culture that were exposed by the Husel cases.
The Mount Carmel CEO; the chief clinical officer; other physician, nursing, and pharmacy leaders; and dozens of nurses and pharmacists were forced out following the Husel investigation.
In 2019, the Centers for Medicare & Medicaid Services, after threatening to cut off federal reimbursements to Mount Carmel, accepted the hospital system’s correction plan restricting the use of verbal drug orders and prohibiting Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.
Mount Carmel and Trinity have settled a number of civil wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. Gerry Leeseberg, a Columbus medical malpractice plaintiff attorney who is representing 17 of the families, said a number of the cases are set for trial starting in June.
During the trial, family members of many of the 14 patients whom Dr. Husel allegedly murdered testified that Dr. Husel told them their loved ones were dying. Some said they felt rushed into making a decision to extubate the person.
Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved ones gasping for breath. But most medical experts – including the state’s two physician expert witnesses – say the fentanyl doses Dr. Husel ordered were 5-20 times larger than doses normally used in palliative extubation. Such doses, they say, will quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.
Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 micrograms for relieving pain, and its 2018 guidelines reduced that to 25-50 micrograms.
The doses Dr. Husel ordered are lethal, even for most patients with some tolerance to opioids, said Rutgers EM chair Dr. Nelson, who practices medical toxicology and addiction medicine. “Those are doses to provide euthanasia, not to relieve pain.”
At trial, the prosecutors had to overcome two big challenges to win murder convictions against Dr. Husel: They had to prove beyond a reasonable doubt that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.
Late in the trial, at the state’s request, the judge ruled to allow the jury to also consider attempted murder charges, which require proof of intent but not that the defendant’s actions directly caused the deaths.
Another challenge was that physicians have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia. That’s what prosecutors accused Dr. Husel of doing.
“If you hasten a person’s death, even if their death is as sure as the sun is going to rise in the morning ... you have caused their death in the eyes of the law,” assistant prosecutor Mr. Zeyen said in his closing. “You don’t get a pass for killing a dying man ...”
Mr. Leeseberg said it was always going to be extremely hard to convince a jury to convict a physician of murder, with the potential of life in prison, in a case where the physician’s acts occurred openly over 4 years in a hospital setting where no one did anything to stop him. It would have been much easier to convince a jury to convict him of reckless homicide, a lesser offense with a shorter prison term. That would have required proving that he acted in reckless disregard for his patients’ health and safety.
In post-verdict comments to the news media, Judge Michael Holbrook said jurors told him that the procedures for the dispensing of fentanyl and other drugs at Mount Carmel weren’t properly explained to them during the trial, and that they were confused by the large number of prosecution witnesses. He also said they were confused that no one had stated a maximum dosage for fentanyl.
Mr. Schumacher, the retired malpractice defense lawyer who followed the trial, disagreed with defense attorney Baez’s takeaway about the impact of the case on pain-relief practices. In his view, the case likely will heighten rather than reduce the anxiety of physicians and nurses about administering opioids, even when the dosages are clearly needed and appropriate. He doesn’t think Dr. Husel’s dosages can be justified, however.
“Physicians have a naive overreaction to any legal development, and overgeneralize from a particular case to everyday practice,” he said.
There is only one known prior case that’s somewhat comparable of a physician tried for murder or attempted murder for giving a critically ill patient opioids for pain relief. In 1996, a Kansas jury convicted Lloyd Stanley Naramore, DO, of attempted murder in the death of a patient to whom he gave an opioid, and of second-degree murder for removing a patient from a ventilator. After Dr. Naramore served 6 months in prison, an appellate court reversed the convictions for lack of evidence.
In March, RaDonda Vaught, a nurse who worked at Vanderbilt University Medical Center in Nashville, Tenn., was convicted of criminal neglect and negligent homicide for mistakenly administering a fatal dose of the paralyzing drug vecuronium, instead of the prescribed drug Versed (midazolam), to a patient. Providers around the country were alarmed by her criminal prosecution for what was clearly an unintentional error.
But legal and medical experts said Dr. Husel’s case was sharply different from Vaught’s and Dr. Naramore’s because he deliberately and repeatedly ordered large doses of fentanyl and other drugs that he knew or should have known were potentially lethal. “You don’t need 2,000 micrograms of fentanyl plus other drugs for comfort care, and repeat that again and again for patient after patient,” said Mr. Cohen, of the Institute for Safe Medication Practices. “No one gives that to patients. You’ll knock them off.”
During the trial, prosecutors said repeatedly that no one except Dr. Husel knows what he was thinking when he ordered those huge drug dosages for his ICU patients. Judge Holbrook told the jury the state did not have to prove motive, only intent. But many observers still have wondered what his motives were.
Dr. Husel’s own view of his care in these cases soon will become public. Immediately after the April 20 verdict, Mr. Leeseberg filed a notice requesting a May 9 deposition of Dr. Husel, who will no longer be able to claim the Fifth Amendment right against self-incrimination. He predicted the deposition will last about a week, and then the transcript will be publicly available.
A version of this article first appeared on Medscape.com.
In an unprecedented murder case about end-of-life care, a physician accused of killing 14 critically ill patients with opioid overdoses in a Columbus, Ohio, hospital ICU over a period of 4 years was found not guilty by a jury April 20.
The jury, after a 7-week trial featuring more than 50 witnesses in the Franklin County Court of Common Pleas, declared William Husel, DO, not guilty on 14 counts of murder and attempted murder.
In a news conference after the verdict was announced, lead defense attorney Jose Baez said Dr. Husel, whom he called a “great doctor,” hopes to practice medicine again in the future. “They don’t need to be looking over their shoulders worrying about whether they’ll get charged with crimes,” he said.
The prosecutors in the case declined to comment, other than to say they “accept” the verdict.
Legal experts said it’s highly unlikely that Ohio or any other state would restore Dr. Husel’s suspended medical license. “I doubt he could ever work in medicine again,” said Mark Schumacher, a Columbus medical malpractice defense attorney who retired in 2020 after practicing for 39 years. Mr. Schumacher followed the trial closely.
The trial raised the specific issue of what constitutes a medically justifiable dose of opioid painkillers during the end-of-life procedure known as palliative extubation, in which critically ill patients are withdrawn from the ventilator when they are expected to die. Under medicine’s so-called double-effect principle, physicians must weigh the benefits and risks of ordering potentially lethal doses of painkillers and sedatives to provide comfort care for critically ill patients.
To many observers, however, the case really centered on the largely hidden debate over whether it’s acceptable to hasten the deaths of dying patients who haven’t chosen that path. That’s called euthanasia, which is illegal in the United States. In contrast, 10 states plus the District of Columbia allow physicians to prescribe lethal drugs to terminally ill, mentally competent adults who can self-administer them. That’s called medical aid in dying, or physician-assisted dying or suicide.
“Maybe this is a wake-up call that people believe this is the right thing to do,” said Lewis Nelson, MD, chair of emergency medicine at New Jersey Medical School in Newark. “The medical community has a sense that we often prolong life unnecessarily. But a physician cannot unilaterally decide it’s time for someone to die. It sounds like [Dr. Husel] took that decision into his own hands.”
The case also exposed major gaps in the patient safety culture at Mount Carmel West Hospital in Columbus, which is owned by the Catholic chain Trinity Health. Experts say failures by hospital staff to question physicians’ orders and raise patient safety concerns, as happened at Mount Carmel, occur at many hospitals around the country. Experts say the Husel case offers vital lessons for health care professionals about improving safety procedures.
“This is an extreme example, that everyone should learn from, about what not to do,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “Husel was giving massive overdoses of drugs, people knew it was problematic, and someone didn’t put their foot down. You’ve got to have a process in place to address these situations where there is disagreement over the safety of a medication order.”
Dr. Husel was charged with killing the 14 patients from 2015 through 2018 by ordering single large doses of the painkiller fentanyl – from 500 to 2,000 micrograms – often in combination with other opioids and sedatives, while working as the solo physician on the overnight shift in the ICU at Mount Carmel West Hospital and at Mount Carmel St. Ann’s Hospital in Westerville, Ohio.
Dr. Husel ordered administration of the drugs while his patients were having an endotracheal tube removed as part of palliative extubation. There was conflicting testimony during the trial about whether the patients were showing signs of pain or were even capable of feeling pain.
Prosecutors argued that Dr. Husel, who did a residency and fellowship in critical care medicine at Cleveland Clinic and started working at Mount Carmel in 2013 in his first job as a full-fledged physician, intended to kill the patients or hasten their deaths. They contended that the inexperienced nurses in the ICU went along with his large drug doses because they were “in thrall” to him because of his prestigious background at the Cleveland Clinic and his willingness to take the time to teach them.
“With his training in anesthesiology, he knew what those drugs do,” assistant prosecutor David Zeyen said in closing arguments. “This isn’t negligence. This is on purpose ... Euthanizing animals with the intent to kill is fine in veterinary medicine. It’s not fine in the ICU at Mount Carmel or anywhere.”
The defense team argued that Dr. Husel was a caring and compassionate physician who ordered the drugs to relieve the patients’ pain and discomfort during the extubation process. He did not testify.
“Common sense says Dr Husel had no motive to harm patients,” defense attorney Baez said in his closing. “He dedicated his life to taking care of patients and saving lives, not taking them. ... Why would this man risk his family, career, and 17 years of trying to be a doctor to hasten someone’s death or kill them?”
There were 35 Mount Carmel patients who died in the ICU under Dr. Husel’s care after receiving large fentanyl doses during palliative extubation. The state originally charged him with murder in 25 of those cases, then reduced that to 14.
Many of Dr. Husel’s drug orders were given verbally instead of through the regular process of being entered into the electronic health record. He and the nurses on duty also skipped the standard nonemergency process of getting approval from the pharmacist on duty, instead using the override function on Mount Carmel’s automated Pyxis drug dispensing system.
Dr. Husel’s unusual dosing patterns were first reported to Mount Carmel officials by pharmacists in October 2018, spurring an investigation. The hospital system let him go in December 2018, after concluding that the opioid dosages he used were “significantly excessive and potentially fatal” and “went beyond providing comfort.”
Nearly two dozen RNs and two pharmacists involved in these cases have faced state disciplinary action, mostly license suspension. Federal and state agencies have cited the Mount Carmel system for faults in its patient safety processes and culture that were exposed by the Husel cases.
The Mount Carmel CEO; the chief clinical officer; other physician, nursing, and pharmacy leaders; and dozens of nurses and pharmacists were forced out following the Husel investigation.
In 2019, the Centers for Medicare & Medicaid Services, after threatening to cut off federal reimbursements to Mount Carmel, accepted the hospital system’s correction plan restricting the use of verbal drug orders and prohibiting Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.
Mount Carmel and Trinity have settled a number of civil wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. Gerry Leeseberg, a Columbus medical malpractice plaintiff attorney who is representing 17 of the families, said a number of the cases are set for trial starting in June.
During the trial, family members of many of the 14 patients whom Dr. Husel allegedly murdered testified that Dr. Husel told them their loved ones were dying. Some said they felt rushed into making a decision to extubate the person.
Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved ones gasping for breath. But most medical experts – including the state’s two physician expert witnesses – say the fentanyl doses Dr. Husel ordered were 5-20 times larger than doses normally used in palliative extubation. Such doses, they say, will quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.
Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 micrograms for relieving pain, and its 2018 guidelines reduced that to 25-50 micrograms.
The doses Dr. Husel ordered are lethal, even for most patients with some tolerance to opioids, said Rutgers EM chair Dr. Nelson, who practices medical toxicology and addiction medicine. “Those are doses to provide euthanasia, not to relieve pain.”
At trial, the prosecutors had to overcome two big challenges to win murder convictions against Dr. Husel: They had to prove beyond a reasonable doubt that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.
Late in the trial, at the state’s request, the judge ruled to allow the jury to also consider attempted murder charges, which require proof of intent but not that the defendant’s actions directly caused the deaths.
Another challenge was that physicians have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia. That’s what prosecutors accused Dr. Husel of doing.
“If you hasten a person’s death, even if their death is as sure as the sun is going to rise in the morning ... you have caused their death in the eyes of the law,” assistant prosecutor Mr. Zeyen said in his closing. “You don’t get a pass for killing a dying man ...”
Mr. Leeseberg said it was always going to be extremely hard to convince a jury to convict a physician of murder, with the potential of life in prison, in a case where the physician’s acts occurred openly over 4 years in a hospital setting where no one did anything to stop him. It would have been much easier to convince a jury to convict him of reckless homicide, a lesser offense with a shorter prison term. That would have required proving that he acted in reckless disregard for his patients’ health and safety.
In post-verdict comments to the news media, Judge Michael Holbrook said jurors told him that the procedures for the dispensing of fentanyl and other drugs at Mount Carmel weren’t properly explained to them during the trial, and that they were confused by the large number of prosecution witnesses. He also said they were confused that no one had stated a maximum dosage for fentanyl.
Mr. Schumacher, the retired malpractice defense lawyer who followed the trial, disagreed with defense attorney Baez’s takeaway about the impact of the case on pain-relief practices. In his view, the case likely will heighten rather than reduce the anxiety of physicians and nurses about administering opioids, even when the dosages are clearly needed and appropriate. He doesn’t think Dr. Husel’s dosages can be justified, however.
“Physicians have a naive overreaction to any legal development, and overgeneralize from a particular case to everyday practice,” he said.
There is only one known prior case that’s somewhat comparable of a physician tried for murder or attempted murder for giving a critically ill patient opioids for pain relief. In 1996, a Kansas jury convicted Lloyd Stanley Naramore, DO, of attempted murder in the death of a patient to whom he gave an opioid, and of second-degree murder for removing a patient from a ventilator. After Dr. Naramore served 6 months in prison, an appellate court reversed the convictions for lack of evidence.
In March, RaDonda Vaught, a nurse who worked at Vanderbilt University Medical Center in Nashville, Tenn., was convicted of criminal neglect and negligent homicide for mistakenly administering a fatal dose of the paralyzing drug vecuronium, instead of the prescribed drug Versed (midazolam), to a patient. Providers around the country were alarmed by her criminal prosecution for what was clearly an unintentional error.
But legal and medical experts said Dr. Husel’s case was sharply different from Vaught’s and Dr. Naramore’s because he deliberately and repeatedly ordered large doses of fentanyl and other drugs that he knew or should have known were potentially lethal. “You don’t need 2,000 micrograms of fentanyl plus other drugs for comfort care, and repeat that again and again for patient after patient,” said Mr. Cohen, of the Institute for Safe Medication Practices. “No one gives that to patients. You’ll knock them off.”
During the trial, prosecutors said repeatedly that no one except Dr. Husel knows what he was thinking when he ordered those huge drug dosages for his ICU patients. Judge Holbrook told the jury the state did not have to prove motive, only intent. But many observers still have wondered what his motives were.
Dr. Husel’s own view of his care in these cases soon will become public. Immediately after the April 20 verdict, Mr. Leeseberg filed a notice requesting a May 9 deposition of Dr. Husel, who will no longer be able to claim the Fifth Amendment right against self-incrimination. He predicted the deposition will last about a week, and then the transcript will be publicly available.
A version of this article first appeared on Medscape.com.
In an unprecedented murder case about end-of-life care, a physician accused of killing 14 critically ill patients with opioid overdoses in a Columbus, Ohio, hospital ICU over a period of 4 years was found not guilty by a jury April 20.
The jury, after a 7-week trial featuring more than 50 witnesses in the Franklin County Court of Common Pleas, declared William Husel, DO, not guilty on 14 counts of murder and attempted murder.
In a news conference after the verdict was announced, lead defense attorney Jose Baez said Dr. Husel, whom he called a “great doctor,” hopes to practice medicine again in the future. “They don’t need to be looking over their shoulders worrying about whether they’ll get charged with crimes,” he said.
The prosecutors in the case declined to comment, other than to say they “accept” the verdict.
Legal experts said it’s highly unlikely that Ohio or any other state would restore Dr. Husel’s suspended medical license. “I doubt he could ever work in medicine again,” said Mark Schumacher, a Columbus medical malpractice defense attorney who retired in 2020 after practicing for 39 years. Mr. Schumacher followed the trial closely.
The trial raised the specific issue of what constitutes a medically justifiable dose of opioid painkillers during the end-of-life procedure known as palliative extubation, in which critically ill patients are withdrawn from the ventilator when they are expected to die. Under medicine’s so-called double-effect principle, physicians must weigh the benefits and risks of ordering potentially lethal doses of painkillers and sedatives to provide comfort care for critically ill patients.
To many observers, however, the case really centered on the largely hidden debate over whether it’s acceptable to hasten the deaths of dying patients who haven’t chosen that path. That’s called euthanasia, which is illegal in the United States. In contrast, 10 states plus the District of Columbia allow physicians to prescribe lethal drugs to terminally ill, mentally competent adults who can self-administer them. That’s called medical aid in dying, or physician-assisted dying or suicide.
“Maybe this is a wake-up call that people believe this is the right thing to do,” said Lewis Nelson, MD, chair of emergency medicine at New Jersey Medical School in Newark. “The medical community has a sense that we often prolong life unnecessarily. But a physician cannot unilaterally decide it’s time for someone to die. It sounds like [Dr. Husel] took that decision into his own hands.”
The case also exposed major gaps in the patient safety culture at Mount Carmel West Hospital in Columbus, which is owned by the Catholic chain Trinity Health. Experts say failures by hospital staff to question physicians’ orders and raise patient safety concerns, as happened at Mount Carmel, occur at many hospitals around the country. Experts say the Husel case offers vital lessons for health care professionals about improving safety procedures.
“This is an extreme example, that everyone should learn from, about what not to do,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “Husel was giving massive overdoses of drugs, people knew it was problematic, and someone didn’t put their foot down. You’ve got to have a process in place to address these situations where there is disagreement over the safety of a medication order.”
Dr. Husel was charged with killing the 14 patients from 2015 through 2018 by ordering single large doses of the painkiller fentanyl – from 500 to 2,000 micrograms – often in combination with other opioids and sedatives, while working as the solo physician on the overnight shift in the ICU at Mount Carmel West Hospital and at Mount Carmel St. Ann’s Hospital in Westerville, Ohio.
Dr. Husel ordered administration of the drugs while his patients were having an endotracheal tube removed as part of palliative extubation. There was conflicting testimony during the trial about whether the patients were showing signs of pain or were even capable of feeling pain.
Prosecutors argued that Dr. Husel, who did a residency and fellowship in critical care medicine at Cleveland Clinic and started working at Mount Carmel in 2013 in his first job as a full-fledged physician, intended to kill the patients or hasten their deaths. They contended that the inexperienced nurses in the ICU went along with his large drug doses because they were “in thrall” to him because of his prestigious background at the Cleveland Clinic and his willingness to take the time to teach them.
“With his training in anesthesiology, he knew what those drugs do,” assistant prosecutor David Zeyen said in closing arguments. “This isn’t negligence. This is on purpose ... Euthanizing animals with the intent to kill is fine in veterinary medicine. It’s not fine in the ICU at Mount Carmel or anywhere.”
The defense team argued that Dr. Husel was a caring and compassionate physician who ordered the drugs to relieve the patients’ pain and discomfort during the extubation process. He did not testify.
“Common sense says Dr Husel had no motive to harm patients,” defense attorney Baez said in his closing. “He dedicated his life to taking care of patients and saving lives, not taking them. ... Why would this man risk his family, career, and 17 years of trying to be a doctor to hasten someone’s death or kill them?”
There were 35 Mount Carmel patients who died in the ICU under Dr. Husel’s care after receiving large fentanyl doses during palliative extubation. The state originally charged him with murder in 25 of those cases, then reduced that to 14.
Many of Dr. Husel’s drug orders were given verbally instead of through the regular process of being entered into the electronic health record. He and the nurses on duty also skipped the standard nonemergency process of getting approval from the pharmacist on duty, instead using the override function on Mount Carmel’s automated Pyxis drug dispensing system.
Dr. Husel’s unusual dosing patterns were first reported to Mount Carmel officials by pharmacists in October 2018, spurring an investigation. The hospital system let him go in December 2018, after concluding that the opioid dosages he used were “significantly excessive and potentially fatal” and “went beyond providing comfort.”
Nearly two dozen RNs and two pharmacists involved in these cases have faced state disciplinary action, mostly license suspension. Federal and state agencies have cited the Mount Carmel system for faults in its patient safety processes and culture that were exposed by the Husel cases.
The Mount Carmel CEO; the chief clinical officer; other physician, nursing, and pharmacy leaders; and dozens of nurses and pharmacists were forced out following the Husel investigation.
In 2019, the Centers for Medicare & Medicaid Services, after threatening to cut off federal reimbursements to Mount Carmel, accepted the hospital system’s correction plan restricting the use of verbal drug orders and prohibiting Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.
Mount Carmel and Trinity have settled a number of civil wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. Gerry Leeseberg, a Columbus medical malpractice plaintiff attorney who is representing 17 of the families, said a number of the cases are set for trial starting in June.
During the trial, family members of many of the 14 patients whom Dr. Husel allegedly murdered testified that Dr. Husel told them their loved ones were dying. Some said they felt rushed into making a decision to extubate the person.
Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved ones gasping for breath. But most medical experts – including the state’s two physician expert witnesses – say the fentanyl doses Dr. Husel ordered were 5-20 times larger than doses normally used in palliative extubation. Such doses, they say, will quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.
Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 micrograms for relieving pain, and its 2018 guidelines reduced that to 25-50 micrograms.
The doses Dr. Husel ordered are lethal, even for most patients with some tolerance to opioids, said Rutgers EM chair Dr. Nelson, who practices medical toxicology and addiction medicine. “Those are doses to provide euthanasia, not to relieve pain.”
At trial, the prosecutors had to overcome two big challenges to win murder convictions against Dr. Husel: They had to prove beyond a reasonable doubt that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.
Late in the trial, at the state’s request, the judge ruled to allow the jury to also consider attempted murder charges, which require proof of intent but not that the defendant’s actions directly caused the deaths.
Another challenge was that physicians have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia. That’s what prosecutors accused Dr. Husel of doing.
“If you hasten a person’s death, even if their death is as sure as the sun is going to rise in the morning ... you have caused their death in the eyes of the law,” assistant prosecutor Mr. Zeyen said in his closing. “You don’t get a pass for killing a dying man ...”
Mr. Leeseberg said it was always going to be extremely hard to convince a jury to convict a physician of murder, with the potential of life in prison, in a case where the physician’s acts occurred openly over 4 years in a hospital setting where no one did anything to stop him. It would have been much easier to convince a jury to convict him of reckless homicide, a lesser offense with a shorter prison term. That would have required proving that he acted in reckless disregard for his patients’ health and safety.
In post-verdict comments to the news media, Judge Michael Holbrook said jurors told him that the procedures for the dispensing of fentanyl and other drugs at Mount Carmel weren’t properly explained to them during the trial, and that they were confused by the large number of prosecution witnesses. He also said they were confused that no one had stated a maximum dosage for fentanyl.
Mr. Schumacher, the retired malpractice defense lawyer who followed the trial, disagreed with defense attorney Baez’s takeaway about the impact of the case on pain-relief practices. In his view, the case likely will heighten rather than reduce the anxiety of physicians and nurses about administering opioids, even when the dosages are clearly needed and appropriate. He doesn’t think Dr. Husel’s dosages can be justified, however.
“Physicians have a naive overreaction to any legal development, and overgeneralize from a particular case to everyday practice,” he said.
There is only one known prior case that’s somewhat comparable of a physician tried for murder or attempted murder for giving a critically ill patient opioids for pain relief. In 1996, a Kansas jury convicted Lloyd Stanley Naramore, DO, of attempted murder in the death of a patient to whom he gave an opioid, and of second-degree murder for removing a patient from a ventilator. After Dr. Naramore served 6 months in prison, an appellate court reversed the convictions for lack of evidence.
In March, RaDonda Vaught, a nurse who worked at Vanderbilt University Medical Center in Nashville, Tenn., was convicted of criminal neglect and negligent homicide for mistakenly administering a fatal dose of the paralyzing drug vecuronium, instead of the prescribed drug Versed (midazolam), to a patient. Providers around the country were alarmed by her criminal prosecution for what was clearly an unintentional error.
But legal and medical experts said Dr. Husel’s case was sharply different from Vaught’s and Dr. Naramore’s because he deliberately and repeatedly ordered large doses of fentanyl and other drugs that he knew or should have known were potentially lethal. “You don’t need 2,000 micrograms of fentanyl plus other drugs for comfort care, and repeat that again and again for patient after patient,” said Mr. Cohen, of the Institute for Safe Medication Practices. “No one gives that to patients. You’ll knock them off.”
During the trial, prosecutors said repeatedly that no one except Dr. Husel knows what he was thinking when he ordered those huge drug dosages for his ICU patients. Judge Holbrook told the jury the state did not have to prove motive, only intent. But many observers still have wondered what his motives were.
Dr. Husel’s own view of his care in these cases soon will become public. Immediately after the April 20 verdict, Mr. Leeseberg filed a notice requesting a May 9 deposition of Dr. Husel, who will no longer be able to claim the Fifth Amendment right against self-incrimination. He predicted the deposition will last about a week, and then the transcript will be publicly available.
A version of this article first appeared on Medscape.com.
Which breast cancer surgery leads to better quality of life?
Women diagnosed with early breast cancer facing surgery often have a choice of having all of their breast or only a part of the breast removed.
A new study shows that a patient’s satisfaction with their breasts at 10 years after surgery is similar for both groups of women.
However, superior psychosocial and sexual well-being at 10 years after surgery was reported by women who underwent breast-conserving surgery and adjuvant radiation therapy (RT), compared with those who underwent mastectomy and reconstruction.
“These findings may inform preference-sensitive decision-making for women with early-stage breast cancer,” write the authors, led by Benjamin D. Smith, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.
The study was published online in JAMA Surgery.
These findings have important implications for patient decision-making, given that more women eligible for breast-conserving surgery are opting for a mastectomy, say Sudheer Vemuru, MD, from the University of Colorado at Denver, Aurora, and colleagues, writing in an accompanying editorial.
“Overall, the preponderance of evidence suggests superior short-term and long-term patient-reported outcomes in patients with early-stage breast cancer undergoing breast conserving surgery compared with mastectomy,” they comment.
Study details
For their study, Dr. Smith and colleagues conducted a comparative effectiveness research study using data from the Texas Cancer Registry and identified women diagnosed with stage 0-II breast cancer and treated with breast-conserving surgery or mastectomy and reconstruction between 2006 and 2008.
A total of 647 patients were included in their analysis (40%; 356 had undergone breast-conserving surgery; 291 had undergone mastectomy and reconstruction), 551 (85.2%) confirmed treatment with breast-conserving surgery with RT (n = 315) or mastectomy and reconstruction without RT (n = 236).
The median age of the cohort was 53 years and the median time from diagnosis to survey was 10.3 years. Mastectomy and reconstruction were more common among women who were White, younger, node positive, had larger tumors, had bilateral breast cancer, received chemotherapy, and had higher income.
The primary outcome was patient satisfaction with their breasts, as measured with the BREAST-Q patient-reported outcome measure. Secondary outcomes included physical well-being, psychosocial well-being, and sexual well-being. The EuroQol Health-Related Quality of Life 5-Dimension, 3-Level gaged health utility, and local therapy decisional regret was measured via the Decisional Regret Scale.
Using breast-conserving surgery plus RT as the referent, the authors did not find any significant differences in breast satisfaction, physical well-being, health utility, or decisional regret among the study cohorts: breast satisfaction: effect size, 2.71 (P = .30); physical well-being: effect size, –1.80 (P = .36); health utility: effect size, –0.003 (P = .83); and decisional regret: effect size, 1.32 (P = .61).
However, psychosocial well-being (effect size, –8.61; P < .001) and sexual well-being (effect size, –10.68; P < .001) were significantly worse among women who had undergone mastectomy and reconstruction without RT.
They noted that interactions of race and ethnicity and age by treatment group were not significant for reported satisfaction with breast outcomes. But the findings “indicated that the burden of poor long-term QOL outcomes was greater among younger individuals, those with lower educational attainment and income, and certain racial and ethnic minority populations,” they write. “These findings suggest that opportunities exist to enhance equity in the long-term QOL of individuals with breast cancer.”
The editorialists note that previous studies have also found diminished quality of life following mastectomy compared with breast-conserving surgery. However, most of these prior studies included patients undergoing breast-conserving surgery without RT, patients undergoing mastectomy without reconstruction, and patients undergoing mastectomy with RT.
In contrast, this latest study “directly compared breast-conserving surgery with RT vs. mastectomy and reconstruction without RT to avoid those potential confounders,” they point out.
The study was supported by grants from the National Cancer Institute and other bodies. Several of the study authors disclosed relationships with industry and/or with nonprofit organizations. The full list can be found with the original article. Editorialist Clara Lee, MD, reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study.
A version of this article first appeared on Medscape.com.
Women diagnosed with early breast cancer facing surgery often have a choice of having all of their breast or only a part of the breast removed.
A new study shows that a patient’s satisfaction with their breasts at 10 years after surgery is similar for both groups of women.
However, superior psychosocial and sexual well-being at 10 years after surgery was reported by women who underwent breast-conserving surgery and adjuvant radiation therapy (RT), compared with those who underwent mastectomy and reconstruction.
“These findings may inform preference-sensitive decision-making for women with early-stage breast cancer,” write the authors, led by Benjamin D. Smith, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.
The study was published online in JAMA Surgery.
These findings have important implications for patient decision-making, given that more women eligible for breast-conserving surgery are opting for a mastectomy, say Sudheer Vemuru, MD, from the University of Colorado at Denver, Aurora, and colleagues, writing in an accompanying editorial.
“Overall, the preponderance of evidence suggests superior short-term and long-term patient-reported outcomes in patients with early-stage breast cancer undergoing breast conserving surgery compared with mastectomy,” they comment.
Study details
For their study, Dr. Smith and colleagues conducted a comparative effectiveness research study using data from the Texas Cancer Registry and identified women diagnosed with stage 0-II breast cancer and treated with breast-conserving surgery or mastectomy and reconstruction between 2006 and 2008.
A total of 647 patients were included in their analysis (40%; 356 had undergone breast-conserving surgery; 291 had undergone mastectomy and reconstruction), 551 (85.2%) confirmed treatment with breast-conserving surgery with RT (n = 315) or mastectomy and reconstruction without RT (n = 236).
The median age of the cohort was 53 years and the median time from diagnosis to survey was 10.3 years. Mastectomy and reconstruction were more common among women who were White, younger, node positive, had larger tumors, had bilateral breast cancer, received chemotherapy, and had higher income.
The primary outcome was patient satisfaction with their breasts, as measured with the BREAST-Q patient-reported outcome measure. Secondary outcomes included physical well-being, psychosocial well-being, and sexual well-being. The EuroQol Health-Related Quality of Life 5-Dimension, 3-Level gaged health utility, and local therapy decisional regret was measured via the Decisional Regret Scale.
Using breast-conserving surgery plus RT as the referent, the authors did not find any significant differences in breast satisfaction, physical well-being, health utility, or decisional regret among the study cohorts: breast satisfaction: effect size, 2.71 (P = .30); physical well-being: effect size, –1.80 (P = .36); health utility: effect size, –0.003 (P = .83); and decisional regret: effect size, 1.32 (P = .61).
However, psychosocial well-being (effect size, –8.61; P < .001) and sexual well-being (effect size, –10.68; P < .001) were significantly worse among women who had undergone mastectomy and reconstruction without RT.
They noted that interactions of race and ethnicity and age by treatment group were not significant for reported satisfaction with breast outcomes. But the findings “indicated that the burden of poor long-term QOL outcomes was greater among younger individuals, those with lower educational attainment and income, and certain racial and ethnic minority populations,” they write. “These findings suggest that opportunities exist to enhance equity in the long-term QOL of individuals with breast cancer.”
The editorialists note that previous studies have also found diminished quality of life following mastectomy compared with breast-conserving surgery. However, most of these prior studies included patients undergoing breast-conserving surgery without RT, patients undergoing mastectomy without reconstruction, and patients undergoing mastectomy with RT.
In contrast, this latest study “directly compared breast-conserving surgery with RT vs. mastectomy and reconstruction without RT to avoid those potential confounders,” they point out.
The study was supported by grants from the National Cancer Institute and other bodies. Several of the study authors disclosed relationships with industry and/or with nonprofit organizations. The full list can be found with the original article. Editorialist Clara Lee, MD, reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study.
A version of this article first appeared on Medscape.com.
Women diagnosed with early breast cancer facing surgery often have a choice of having all of their breast or only a part of the breast removed.
A new study shows that a patient’s satisfaction with their breasts at 10 years after surgery is similar for both groups of women.
However, superior psychosocial and sexual well-being at 10 years after surgery was reported by women who underwent breast-conserving surgery and adjuvant radiation therapy (RT), compared with those who underwent mastectomy and reconstruction.
“These findings may inform preference-sensitive decision-making for women with early-stage breast cancer,” write the authors, led by Benjamin D. Smith, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.
The study was published online in JAMA Surgery.
These findings have important implications for patient decision-making, given that more women eligible for breast-conserving surgery are opting for a mastectomy, say Sudheer Vemuru, MD, from the University of Colorado at Denver, Aurora, and colleagues, writing in an accompanying editorial.
“Overall, the preponderance of evidence suggests superior short-term and long-term patient-reported outcomes in patients with early-stage breast cancer undergoing breast conserving surgery compared with mastectomy,” they comment.
Study details
For their study, Dr. Smith and colleagues conducted a comparative effectiveness research study using data from the Texas Cancer Registry and identified women diagnosed with stage 0-II breast cancer and treated with breast-conserving surgery or mastectomy and reconstruction between 2006 and 2008.
A total of 647 patients were included in their analysis (40%; 356 had undergone breast-conserving surgery; 291 had undergone mastectomy and reconstruction), 551 (85.2%) confirmed treatment with breast-conserving surgery with RT (n = 315) or mastectomy and reconstruction without RT (n = 236).
The median age of the cohort was 53 years and the median time from diagnosis to survey was 10.3 years. Mastectomy and reconstruction were more common among women who were White, younger, node positive, had larger tumors, had bilateral breast cancer, received chemotherapy, and had higher income.
The primary outcome was patient satisfaction with their breasts, as measured with the BREAST-Q patient-reported outcome measure. Secondary outcomes included physical well-being, psychosocial well-being, and sexual well-being. The EuroQol Health-Related Quality of Life 5-Dimension, 3-Level gaged health utility, and local therapy decisional regret was measured via the Decisional Regret Scale.
Using breast-conserving surgery plus RT as the referent, the authors did not find any significant differences in breast satisfaction, physical well-being, health utility, or decisional regret among the study cohorts: breast satisfaction: effect size, 2.71 (P = .30); physical well-being: effect size, –1.80 (P = .36); health utility: effect size, –0.003 (P = .83); and decisional regret: effect size, 1.32 (P = .61).
However, psychosocial well-being (effect size, –8.61; P < .001) and sexual well-being (effect size, –10.68; P < .001) were significantly worse among women who had undergone mastectomy and reconstruction without RT.
They noted that interactions of race and ethnicity and age by treatment group were not significant for reported satisfaction with breast outcomes. But the findings “indicated that the burden of poor long-term QOL outcomes was greater among younger individuals, those with lower educational attainment and income, and certain racial and ethnic minority populations,” they write. “These findings suggest that opportunities exist to enhance equity in the long-term QOL of individuals with breast cancer.”
The editorialists note that previous studies have also found diminished quality of life following mastectomy compared with breast-conserving surgery. However, most of these prior studies included patients undergoing breast-conserving surgery without RT, patients undergoing mastectomy without reconstruction, and patients undergoing mastectomy with RT.
In contrast, this latest study “directly compared breast-conserving surgery with RT vs. mastectomy and reconstruction without RT to avoid those potential confounders,” they point out.
The study was supported by grants from the National Cancer Institute and other bodies. Several of the study authors disclosed relationships with industry and/or with nonprofit organizations. The full list can be found with the original article. Editorialist Clara Lee, MD, reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study.
A version of this article first appeared on Medscape.com.
FROM JAMA SURGERY