A new clinical practice update expert review for the diagnosis and management of atrophic gastritis (AG) from the American Gastroenterological Association focuses on cases linked to Helicobacter pylori infection or autoimmunity.

This update addresses a sparsity of guidelines for AG in the United States and should be seen as complementary to the AGA Clinical Practice Guidelines on Management of Gastric Intestinal Metaplasia, according to the authors led by Shailja C. Shah, MD, MPH, of the gastroenterology section at Veterans Affairs San Diego Healthcare System and the division of gastroenterology at the University of California, San Diego.

The 2020 guidelines didn’t specifically discuss diagnosis and management of AG; however, a diagnosis of intestinal metaplasia based on gastric histopathology indicates the presence AG since metaplasia occurs in atrophic mucosa. Nevertheless, AG often goes unmentioned in histopathology reports. Such omissions are important because AG is an important stage in the potential development of gastric cancer.

AG is believed to result from genetic and environmental factors. The two primary triggers for the condition are H. pylori infection (HpAG) and autoimmunity (AIG). The condition results from chronic inflammation and replacement of normal gastric glandular structures with connective tissue or nonnative epithelium. It can proceed to other precancerous conditions, including gastric intestinal metaplasia and dysplasia. An estimated 15% of the U.S. population has AG, according to the authors, although this prevalence could be higher in populations with higher rates of H. pylori infection. AIG is rare, occurring in 0.5%-2% of the U.S. population.

Among individuals with AG, 0.1%-0.3% per year go on to develop gastric adenocarcinoma, though additional factors could heighten this risk. Furthermore, 0.4%-0.7% per year go on develop type 1 neuroendocrine tumors.

HpAG and AIG have different patterns of mucosal involvement. During diagnosis, the authors advised careful mucosal visualization with air insufflation and mucosal cleansing. High-definition white-light endoscopy is more sensitive than traditional WLE in the identification of premalignant mucosal changes.

AG diagnosis should be confirmed by histopathology. The updated Sydney protocol should be used to obtain biopsies, and serum pepsinogens can be used to identify extensive atrophy, though this testing is not generally available in the United States for clinical use. When histology results are suggestive of AIG, the presence of parietal cell antibodies and intrinsic factor antibodies can contribute to a diagnosis, although the former can be prone to false positives because of H. pylori infection, and the latter has low sensitivity.

Patients identified with AG should be tested for H. pylori and treated for infection, followed by nonserologic testing to confirm treatment success. If H. pylori is present, successful eradication may allow for reversal of AG to normal gastric mucosa; however, patients may have irreversible changes. This could leave them at elevated risk of further progression, though elimination of H. pylori does appear to blunt that risk somewhat.

Neoplastic complications from AG are rare, and the benefits of surveillance among those with AG have not been demonstrated in prospective trials. Observational trials show that severe AG is associated with greater risk of gastric adenocarcinoma, and other factors, such as comorbidities and patient values and priorities, should inform decision-making. When called for, providers should consider surveillance endoscopies every 3 years, though the authors noted that the optimal surveillance interval is unknown. Factors such as the quality of the original endoscopy, family history of gastric cancer, and a history of immigration from regions with high rates of H. pylori infection may impact decisions on surveillance intervals.

AG can lead to iron or vitamin B₁₂ deficiency, so patients with AG, especially those with corpus-predominant AG, should be evaluated for both. AG should also be considered as a differential diagnosis in patients presenting with either deficiency.

A diagnosis of AIG should be accompanied by screening for autoimmune thyroid disease, and type 1 diabetes or Addison’s disease may also be indicated if clinical presentation is consistent.

Because AG is commonly underdiagnosed, the authors advise that gastroenterologists and pathologists should improve coordination to maximize diagnosis of the condition, and they call for comparative clinical trials to improve risk stratification algorithms and surveillance strategies.

The authors disclose no relevant conflicts of interest.

A new clinical practice update expert review for the diagnosis and management of atrophic gastritis (AG) from the American Gastroenterological Association focuses on cases linked to Helicobacter pylori infection or autoimmunity.

This update addresses a sparsity of guidelines for AG in the United States and should be seen as complementary to the AGA Clinical Practice Guidelines on Management of Gastric Intestinal Metaplasia, according to the authors led by Shailja C. Shah, MD, MPH, of the gastroenterology section at Veterans Affairs San Diego Healthcare System and the division of gastroenterology at the University of California, San Diego.

The 2020 guidelines didn’t specifically discuss diagnosis and management of AG; however, a diagnosis of intestinal metaplasia based on gastric histopathology indicates the presence AG since metaplasia occurs in atrophic mucosa. Nevertheless, AG often goes unmentioned in histopathology reports. Such omissions are important because AG is an important stage in the potential development of gastric cancer.

AG is believed to result from genetic and environmental factors. The two primary triggers for the condition are H. pylori infection (HpAG) and autoimmunity (AIG). The condition results from chronic inflammation and replacement of normal gastric glandular structures with connective tissue or nonnative epithelium. It can proceed to other precancerous conditions, including gastric intestinal metaplasia and dysplasia. An estimated 15% of the U.S. population has AG, according to the authors, although this prevalence could be higher in populations with higher rates of H. pylori infection. AIG is rare, occurring in 0.5%-2% of the U.S. population.

Among individuals with AG, 0.1%-0.3% per year go on to develop gastric adenocarcinoma, though additional factors could heighten this risk. Furthermore, 0.4%-0.7% per year go on develop type 1 neuroendocrine tumors.

HpAG and AIG have different patterns of mucosal involvement. During diagnosis, the authors advised careful mucosal visualization with air insufflation and mucosal cleansing. High-definition white-light endoscopy is more sensitive than traditional WLE in the identification of premalignant mucosal changes.

AG diagnosis should be confirmed by histopathology. The updated Sydney protocol should be used to obtain biopsies, and serum pepsinogens can be used to identify extensive atrophy, though this testing is not generally available in the United States for clinical use. When histology results are suggestive of AIG, the presence of parietal cell antibodies and intrinsic factor antibodies can contribute to a diagnosis, although the former can be prone to false positives because of H. pylori infection, and the latter has low sensitivity.

Patients identified with AG should be tested for H. pylori and treated for infection, followed by nonserologic testing to confirm treatment success. If H. pylori is present, successful eradication may allow for reversal of AG to normal gastric mucosa; however, patients may have irreversible changes. This could leave them at elevated risk of further progression, though elimination of H. pylori does appear to blunt that risk somewhat.

Neoplastic complications from AG are rare, and the benefits of surveillance among those with AG have not been demonstrated in prospective trials. Observational trials show that severe AG is associated with greater risk of gastric adenocarcinoma, and other factors, such as comorbidities and patient values and priorities, should inform decision-making. When called for, providers should consider surveillance endoscopies every 3 years, though the authors noted that the optimal surveillance interval is unknown. Factors such as the quality of the original endoscopy, family history of gastric cancer, and a history of immigration from regions with high rates of H. pylori infection may impact decisions on surveillance intervals.

AG can lead to iron or vitamin B₁₂ deficiency, so patients with AG, especially those with corpus-predominant AG, should be evaluated for both. AG should also be considered as a differential diagnosis in patients presenting with either deficiency.

A diagnosis of AIG should be accompanied by screening for autoimmune thyroid disease, and type 1 diabetes or Addison’s disease may also be indicated if clinical presentation is consistent.

Because AG is commonly underdiagnosed, the authors advise that gastroenterologists and pathologists should improve coordination to maximize diagnosis of the condition, and they call for comparative clinical trials to improve risk stratification algorithms and surveillance strategies.

The authors disclose no relevant conflicts of interest.

A new clinical practice update expert review for the diagnosis and management of atrophic gastritis (AG) from the American Gastroenterological Association focuses on cases linked to Helicobacter pylori infection or autoimmunity.

This update addresses a sparsity of guidelines for AG in the United States and should be seen as complementary to the AGA Clinical Practice Guidelines on Management of Gastric Intestinal Metaplasia, according to the authors led by Shailja C. Shah, MD, MPH, of the gastroenterology section at Veterans Affairs San Diego Healthcare System and the division of gastroenterology at the University of California, San Diego.

The 2020 guidelines didn’t specifically discuss diagnosis and management of AG; however, a diagnosis of intestinal metaplasia based on gastric histopathology indicates the presence AG since metaplasia occurs in atrophic mucosa. Nevertheless, AG often goes unmentioned in histopathology reports. Such omissions are important because AG is an important stage in the potential development of gastric cancer.

AG is believed to result from genetic and environmental factors. The two primary triggers for the condition are H. pylori infection (HpAG) and autoimmunity (AIG). The condition results from chronic inflammation and replacement of normal gastric glandular structures with connective tissue or nonnative epithelium. It can proceed to other precancerous conditions, including gastric intestinal metaplasia and dysplasia. An estimated 15% of the U.S. population has AG, according to the authors, although this prevalence could be higher in populations with higher rates of H. pylori infection. AIG is rare, occurring in 0.5%-2% of the U.S. population.

Among individuals with AG, 0.1%-0.3% per year go on to develop gastric adenocarcinoma, though additional factors could heighten this risk. Furthermore, 0.4%-0.7% per year go on develop type 1 neuroendocrine tumors.

HpAG and AIG have different patterns of mucosal involvement. During diagnosis, the authors advised careful mucosal visualization with air insufflation and mucosal cleansing. High-definition white-light endoscopy is more sensitive than traditional WLE in the identification of premalignant mucosal changes.

AG diagnosis should be confirmed by histopathology. The updated Sydney protocol should be used to obtain biopsies, and serum pepsinogens can be used to identify extensive atrophy, though this testing is not generally available in the United States for clinical use. When histology results are suggestive of AIG, the presence of parietal cell antibodies and intrinsic factor antibodies can contribute to a diagnosis, although the former can be prone to false positives because of H. pylori infection, and the latter has low sensitivity.

Patients identified with AG should be tested for H. pylori and treated for infection, followed by nonserologic testing to confirm treatment success. If H. pylori is present, successful eradication may allow for reversal of AG to normal gastric mucosa; however, patients may have irreversible changes. This could leave them at elevated risk of further progression, though elimination of H. pylori does appear to blunt that risk somewhat.

Neoplastic complications from AG are rare, and the benefits of surveillance among those with AG have not been demonstrated in prospective trials. Observational trials show that severe AG is associated with greater risk of gastric adenocarcinoma, and other factors, such as comorbidities and patient values and priorities, should inform decision-making. When called for, providers should consider surveillance endoscopies every 3 years, though the authors noted that the optimal surveillance interval is unknown. Factors such as the quality of the original endoscopy, family history of gastric cancer, and a history of immigration from regions with high rates of H. pylori infection may impact decisions on surveillance intervals.

AG can lead to iron or vitamin B₁₂ deficiency, so patients with AG, especially those with corpus-predominant AG, should be evaluated for both. AG should also be considered as a differential diagnosis in patients presenting with either deficiency.

A diagnosis of AIG should be accompanied by screening for autoimmune thyroid disease, and type 1 diabetes or Addison’s disease may also be indicated if clinical presentation is consistent.

Because AG is commonly underdiagnosed, the authors advise that gastroenterologists and pathologists should improve coordination to maximize diagnosis of the condition, and they call for comparative clinical trials to improve risk stratification algorithms and surveillance strategies.

The authors disclose no relevant conflicts of interest.

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”

The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.

Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.

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

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”

The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.

Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.

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

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”

The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.

Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.

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

Nearly 2 years into the pandemic, all things COVID-19 will of course be a major focus at the annual meeting of the American College of Chest Physicians, held virtually this year.

“During the pandemic, critical care has been at the forefront of what people are interested in,” said CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford.

“There is so much volume in critical care units that people have interest in anything related to critical care, including infectious diseases and disaster management in critical care,” he said in an interview.

Sessions at this year’s meeting that have a COVID-19 theme will focus on care of both patients and caregivers. Multiple symposiums, oral abstracts, scientific posters, and case reports will focus on clinical aspects of SARS-CoV-2 infections and COVID-19, including complications such as ventilator-associated and hospital-acquired pneumonia, a session called “Viruses, Variants, Vaccines, and Virulence: The Present and Future of COVID-19,” and support of patients and families.

Other presentations will focus on how COVID-19 has affected lung cancer screening, outpatient practices, pulmonary care, and sleep medicine.

Importantly, the meeting will include sessions focusing on the mental, physical, and social health of clinicians, especially those on the front lines in critical care and intensive care units. There will be sessions on how to recognize and avoid burnout, practice mental health awareness, and take time for self-care.

Presidential Honor Lecturer Curtis N. Sessler, MD, Master FCCP, FCCM, of Virginia Commonwealth University, Richmond, with give a talk titled, “Navigating the Road to Well-Being in the ICU.”
 

Empathy and diversity

Program cochair David Zielinski, MD, FCCP, of Montreal Children’s Hospital, Quebec, told this news organization that the COVID-19 pandemic has brought into even starker contrast inequities in patient care and in the health care system at large.

“This is a subject people are very keen about right now, whether it’s about how providers are treated, opportunities for improvement, or correcting inequities in outcomes for patients,” he said in an interview.

The program doesn’t shy away from the controversy, either, with a session provocatively titled, “Racism in Health Care: The Fuel That Lit the COVID-19 Fire.”

Keynote speaker Demondes Haynes, MD, FCCP, professor of medicine and associate dean of admissions at the University of Mississippi, Jackson, will speak on the importance of empathy in physician-patient communications and on ways to create a more diverse and inclusive workforce in medicine.
 

Beyond COVID-19

CHEST 2021 will include important information for sleep medicine physicians, including the latest news regarding an equipment recall affecting one of the two major manufacturers of continuous positive airway pressure devices.

“This has caused a lot of angst among sleep physicians and patients, and there are not enough devices to replace them,” Dr. Zielinski said.

“People who are on home ventilators are also affected by this recall,” Dr. Carroll added. “The population of patients who have sleep apnea is much greater than the population who are on home ventilators, but patients who are on home ventilators need it to save their lives.”

The meeting will include informative sessions summarizing U.S. and European asthma guidelines published over the past 2 years, as well as pending guidelines from the American College of Chest Physicians on venous thromboembolism and lung cancer screening.

Additional topics of importance include chronic obstructive pulmonary disease, interstitial lung disease, asthma management, acute respiratory failure in special populations, new therapies and strategies for treating tuberculosis, and many others.

There will be skill-polishing simulation sessions designed to help clinicians connect with experts in the field, update their knowledge, and sharpen their technique.
 

Fun and games

In addition to the serious subjects, CHEST 2021 attendees will have the chance to network with colleagues and friends and enjoy online games, including the 20th annual CHEST Challenge, which will pit teams of fellows-in-training from the Interfaith Medical Center, in Brooklyn, New York; the State University of New York, in Buffalo; and the Ohio State University Medical Center, in Columbus, in a Jeopardy!-style battle of wits and medical knowledge.

Close to 7,000 registrants from around the world took part in last year’s CHEST annual meeting, and a similar number is expected for this year’s edition, Dr. Carroll and Dr. Zielinski said.
 

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

Nearly 2 years into the pandemic, all things COVID-19 will of course be a major focus at the annual meeting of the American College of Chest Physicians, held virtually this year.

“During the pandemic, critical care has been at the forefront of what people are interested in,” said CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford.

“There is so much volume in critical care units that people have interest in anything related to critical care, including infectious diseases and disaster management in critical care,” he said in an interview.

Sessions at this year’s meeting that have a COVID-19 theme will focus on care of both patients and caregivers. Multiple symposiums, oral abstracts, scientific posters, and case reports will focus on clinical aspects of SARS-CoV-2 infections and COVID-19, including complications such as ventilator-associated and hospital-acquired pneumonia, a session called “Viruses, Variants, Vaccines, and Virulence: The Present and Future of COVID-19,” and support of patients and families.

Other presentations will focus on how COVID-19 has affected lung cancer screening, outpatient practices, pulmonary care, and sleep medicine.

Importantly, the meeting will include sessions focusing on the mental, physical, and social health of clinicians, especially those on the front lines in critical care and intensive care units. There will be sessions on how to recognize and avoid burnout, practice mental health awareness, and take time for self-care.

Presidential Honor Lecturer Curtis N. Sessler, MD, Master FCCP, FCCM, of Virginia Commonwealth University, Richmond, with give a talk titled, “Navigating the Road to Well-Being in the ICU.”
 

Empathy and diversity

Program cochair David Zielinski, MD, FCCP, of Montreal Children’s Hospital, Quebec, told this news organization that the COVID-19 pandemic has brought into even starker contrast inequities in patient care and in the health care system at large.

“This is a subject people are very keen about right now, whether it’s about how providers are treated, opportunities for improvement, or correcting inequities in outcomes for patients,” he said in an interview.

The program doesn’t shy away from the controversy, either, with a session provocatively titled, “Racism in Health Care: The Fuel That Lit the COVID-19 Fire.”

Keynote speaker Demondes Haynes, MD, FCCP, professor of medicine and associate dean of admissions at the University of Mississippi, Jackson, will speak on the importance of empathy in physician-patient communications and on ways to create a more diverse and inclusive workforce in medicine.
 

Beyond COVID-19

CHEST 2021 will include important information for sleep medicine physicians, including the latest news regarding an equipment recall affecting one of the two major manufacturers of continuous positive airway pressure devices.

“This has caused a lot of angst among sleep physicians and patients, and there are not enough devices to replace them,” Dr. Zielinski said.

“People who are on home ventilators are also affected by this recall,” Dr. Carroll added. “The population of patients who have sleep apnea is much greater than the population who are on home ventilators, but patients who are on home ventilators need it to save their lives.”

The meeting will include informative sessions summarizing U.S. and European asthma guidelines published over the past 2 years, as well as pending guidelines from the American College of Chest Physicians on venous thromboembolism and lung cancer screening.

Additional topics of importance include chronic obstructive pulmonary disease, interstitial lung disease, asthma management, acute respiratory failure in special populations, new therapies and strategies for treating tuberculosis, and many others.

There will be skill-polishing simulation sessions designed to help clinicians connect with experts in the field, update their knowledge, and sharpen their technique.
 

Fun and games

In addition to the serious subjects, CHEST 2021 attendees will have the chance to network with colleagues and friends and enjoy online games, including the 20th annual CHEST Challenge, which will pit teams of fellows-in-training from the Interfaith Medical Center, in Brooklyn, New York; the State University of New York, in Buffalo; and the Ohio State University Medical Center, in Columbus, in a Jeopardy!-style battle of wits and medical knowledge.

Close to 7,000 registrants from around the world took part in last year’s CHEST annual meeting, and a similar number is expected for this year’s edition, Dr. Carroll and Dr. Zielinski said.
 

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

Nearly 2 years into the pandemic, all things COVID-19 will of course be a major focus at the annual meeting of the American College of Chest Physicians, held virtually this year.

“During the pandemic, critical care has been at the forefront of what people are interested in,” said CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford.

“There is so much volume in critical care units that people have interest in anything related to critical care, including infectious diseases and disaster management in critical care,” he said in an interview.

Sessions at this year’s meeting that have a COVID-19 theme will focus on care of both patients and caregivers. Multiple symposiums, oral abstracts, scientific posters, and case reports will focus on clinical aspects of SARS-CoV-2 infections and COVID-19, including complications such as ventilator-associated and hospital-acquired pneumonia, a session called “Viruses, Variants, Vaccines, and Virulence: The Present and Future of COVID-19,” and support of patients and families.

Other presentations will focus on how COVID-19 has affected lung cancer screening, outpatient practices, pulmonary care, and sleep medicine.

Importantly, the meeting will include sessions focusing on the mental, physical, and social health of clinicians, especially those on the front lines in critical care and intensive care units. There will be sessions on how to recognize and avoid burnout, practice mental health awareness, and take time for self-care.

Presidential Honor Lecturer Curtis N. Sessler, MD, Master FCCP, FCCM, of Virginia Commonwealth University, Richmond, with give a talk titled, “Navigating the Road to Well-Being in the ICU.”
 

Empathy and diversity

Program cochair David Zielinski, MD, FCCP, of Montreal Children’s Hospital, Quebec, told this news organization that the COVID-19 pandemic has brought into even starker contrast inequities in patient care and in the health care system at large.

“This is a subject people are very keen about right now, whether it’s about how providers are treated, opportunities for improvement, or correcting inequities in outcomes for patients,” he said in an interview.

The program doesn’t shy away from the controversy, either, with a session provocatively titled, “Racism in Health Care: The Fuel That Lit the COVID-19 Fire.”

Keynote speaker Demondes Haynes, MD, FCCP, professor of medicine and associate dean of admissions at the University of Mississippi, Jackson, will speak on the importance of empathy in physician-patient communications and on ways to create a more diverse and inclusive workforce in medicine.
 

Beyond COVID-19

CHEST 2021 will include important information for sleep medicine physicians, including the latest news regarding an equipment recall affecting one of the two major manufacturers of continuous positive airway pressure devices.

“This has caused a lot of angst among sleep physicians and patients, and there are not enough devices to replace them,” Dr. Zielinski said.

“People who are on home ventilators are also affected by this recall,” Dr. Carroll added. “The population of patients who have sleep apnea is much greater than the population who are on home ventilators, but patients who are on home ventilators need it to save their lives.”

The meeting will include informative sessions summarizing U.S. and European asthma guidelines published over the past 2 years, as well as pending guidelines from the American College of Chest Physicians on venous thromboembolism and lung cancer screening.

Additional topics of importance include chronic obstructive pulmonary disease, interstitial lung disease, asthma management, acute respiratory failure in special populations, new therapies and strategies for treating tuberculosis, and many others.

There will be skill-polishing simulation sessions designed to help clinicians connect with experts in the field, update their knowledge, and sharpen their technique.
 

Fun and games

In addition to the serious subjects, CHEST 2021 attendees will have the chance to network with colleagues and friends and enjoy online games, including the 20th annual CHEST Challenge, which will pit teams of fellows-in-training from the Interfaith Medical Center, in Brooklyn, New York; the State University of New York, in Buffalo; and the Ohio State University Medical Center, in Columbus, in a Jeopardy!-style battle of wits and medical knowledge.

Close to 7,000 registrants from around the world took part in last year’s CHEST annual meeting, and a similar number is expected for this year’s edition, Dr. Carroll and Dr. Zielinski said.
 

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

A case report describes the dramatic shrinkage of a tumor to a quarter of its original size in a patient with non–small cell lung cancer (NSCLC) who had declined conventional treatment, continued smoking, and who later revealed that she was ingesting cannabidiol (CBD) oil.

The patient was an 80-year-old woman.

At diagnosis, the tumor measured 41 mm, and there was no evidence of local or further spread. Hence, it was suitable for a standard treatment regimen of surgery, chemotherapy, and radiotherapy, note the authors.

The patient declined conventional treatment. She underwent monitoring with regular CT scans every 3–6 months.

After 2.5 years, the CT scans showed that the tumor had shrunk to 10 mm.

The patient then disclosed that she had been ingesting CBD oil, which had been suggested to her by a family member. It was taken orally about two to three times a day.

Details of the case were published on October 14 in BMJ Case Reports.

“We are aware of the limitations of this case report,” write the authors, led by Kah Ling Liew, MD, of Watford General Hospital, Watford, United Kingdom.

“Although there appears to be a relationship between the intake of ‘CBD oil’ and the observed tumour regression, we are unable to conclusively confirm that the tumour regression is due to the patient taking ‘CBD oil,’ ” they comment.

The team also notes that there are similar case reports in the medical literature.

Both points were emphasized by experts reacting to the publication via the UK Science Media Center.

“This is one of many such promising single case reports of medical cannabis self-treatment for various cancers,” said David Nutt, DM, FRCP, FRCPsych, the Edmond J. Safra Chair in Neuropsychopharmacology, Imperial College London, United Kingdom. “Such case reports are biologically credible given the adaptogenic nature of the endocannabinoid system.”

He noted that a “case report itself is not sufficient to give any form of proof that one thing caused the other -- we need trials for that. There are some controlled trials already started and more are required to properly explore the potential of medical cannabis in a range of cancers.”

Another expert, Edzard Ernst, MD, PhD, professor emeritus of complementary medicine, University of Exeter, United Kingdom, pointed out that in animal models, cannabinoids have reduced the size of prostate cancer tumors. “Previous case reports have yielded encouraging findings also in human cancers,” he noted. He too said that further study is needed.

“Case reports cannot be considered to be reliable evidence, and there are currently no data from rigorous clinical trials to suggest that cannabis products will alter the natural history of any cancer,”Dr. Ernst said.

Patient declined recommended treatment

The patient initially presented with a persistent cough that did not resolve with antibiotic therapy. She has a history of mild chronic obstructive pulmonary disease, osteoarthritis, and hypertension. She is a current smoker with a 68 pack-year history of smoking. She has no history of alcohol consumption and is taking several prescription medications.

After an initial CT scan, she underwent a CT-guided lung biopsy and was diagnosed with NSCLC (TNM stage T2bN0Mx). Further analysis of the tumor tissue showed that it was negative for ALK and EGFR mutations. PDL1 was expressed by <1% of the tumor cells. No distant metastases were detected.

A subsequent CT scan revealed that the main tumor in her right middle lobe had shrunk from 41 mm to 33 mm. There were new bilateral upper lobe nodules, one in the left apex, which measured 4 mm, and one in right apex, which measured 6 mm.

The patient was referred to cardiothoracic surgeons for a possible lobectomy, but the patient declined to have surgery. She was then referred to the oncologists. She underwent repeat CT and positron-emission tomography (PET) scans, which showed that her cancer had continued to shrink. On CT, there was an 11-mm reduction, and on PET, an 18-mm reduction. The left apical nodule had resolved, and the right upper lobe nodule was reduced in size.

The patient was offered stereotactic ablative radiotherapy, but she declined this treatment. Because she had refused all standard therapies, a decision was made to “watch and wait.” The patient underwent regular CT surveillance.

Over the course of 2.5 years, the tumor continued to regress. By February 2021, it had shrunk to 10 mm, which represents an overall reduction of 76% in maximum axial diameter. The average rate of reduction was 2.4% per month throughout the monitoring period.

“This case was brought to the attention of the local lung MDT [multidisciplinary team] in February 2019 when the serial imaging showed a reduction in tumor size despite having received no conventional treatment for her lung cancer,” write the authors.

The patient was contacted to discuss her results. She revealed that she was using CBD oil and that she had started taking it in August 2018. No changes had been made in her prescription medications, diet, and lifestyle, and she continued to smoke a pack of cigarettes every week.

“I was not very interested in traditional cancer treatments,” the patient said, “as I was worried about the risks of surgery, and I saw my late husband suffer through the side effects of radiotherapy. My relative suggested that I should try ‘cannabidiol (CBD) oil’ to treat my cancer, and I have been taking it regularly ever since. I am ‘over the moon’ with my cancer shrinking, which I believe was caused by the ‘CBD oil’. I am tolerating it very well and I intend to take this treatment indefinitely.”

The source of the CBD oil was outside the United Kingdom. The main active ingredients, according to her supplier, were Δ9-tetrahydrocannabinol (THC), at 19.5%, CBD, at 20.05%, and tetrahydrocannabinolic acid, at 23.8%.

“The product used by this patient reportedly contained high levels of THC (the intoxicating component of cannabis) and was sourced from outside the U.K.,” commented Tom Freeman, PhD, senior lecturer and director of the Addiction and Mental Health Group, University of Bath, United Kingdom. “This type of product is very different to most CBD oils, which predominantly contain CBD. Unlike prescribed medicines, CBD wellness products lack assurance of quality, safety, or efficacy and should not be used for medicinal purposes.”

The authors have disclosed no relevant financial relationships. Dr. Nutt chairs the scientific committee of the charity Drug Science, which receives unrestricted educational grants from some medical cannabis companies. Dr. Ernst and Dr. Freeman have disclosed no relevant financial relationships.

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

A case report describes the dramatic shrinkage of a tumor to a quarter of its original size in a patient with non–small cell lung cancer (NSCLC) who had declined conventional treatment, continued smoking, and who later revealed that she was ingesting cannabidiol (CBD) oil.

The patient was an 80-year-old woman.

At diagnosis, the tumor measured 41 mm, and there was no evidence of local or further spread. Hence, it was suitable for a standard treatment regimen of surgery, chemotherapy, and radiotherapy, note the authors.

The patient declined conventional treatment. She underwent monitoring with regular CT scans every 3–6 months.

After 2.5 years, the CT scans showed that the tumor had shrunk to 10 mm.

The patient then disclosed that she had been ingesting CBD oil, which had been suggested to her by a family member. It was taken orally about two to three times a day.

Details of the case were published on October 14 in BMJ Case Reports.

“We are aware of the limitations of this case report,” write the authors, led by Kah Ling Liew, MD, of Watford General Hospital, Watford, United Kingdom.

“Although there appears to be a relationship between the intake of ‘CBD oil’ and the observed tumour regression, we are unable to conclusively confirm that the tumour regression is due to the patient taking ‘CBD oil,’ ” they comment.

The team also notes that there are similar case reports in the medical literature.

Both points were emphasized by experts reacting to the publication via the UK Science Media Center.

“This is one of many such promising single case reports of medical cannabis self-treatment for various cancers,” said David Nutt, DM, FRCP, FRCPsych, the Edmond J. Safra Chair in Neuropsychopharmacology, Imperial College London, United Kingdom. “Such case reports are biologically credible given the adaptogenic nature of the endocannabinoid system.”

He noted that a “case report itself is not sufficient to give any form of proof that one thing caused the other -- we need trials for that. There are some controlled trials already started and more are required to properly explore the potential of medical cannabis in a range of cancers.”

Another expert, Edzard Ernst, MD, PhD, professor emeritus of complementary medicine, University of Exeter, United Kingdom, pointed out that in animal models, cannabinoids have reduced the size of prostate cancer tumors. “Previous case reports have yielded encouraging findings also in human cancers,” he noted. He too said that further study is needed.

“Case reports cannot be considered to be reliable evidence, and there are currently no data from rigorous clinical trials to suggest that cannabis products will alter the natural history of any cancer,”Dr. Ernst said.

Patient declined recommended treatment

The patient initially presented with a persistent cough that did not resolve with antibiotic therapy. She has a history of mild chronic obstructive pulmonary disease, osteoarthritis, and hypertension. She is a current smoker with a 68 pack-year history of smoking. She has no history of alcohol consumption and is taking several prescription medications.

After an initial CT scan, she underwent a CT-guided lung biopsy and was diagnosed with NSCLC (TNM stage T2bN0Mx). Further analysis of the tumor tissue showed that it was negative for ALK and EGFR mutations. PDL1 was expressed by <1% of the tumor cells. No distant metastases were detected.

A subsequent CT scan revealed that the main tumor in her right middle lobe had shrunk from 41 mm to 33 mm. There were new bilateral upper lobe nodules, one in the left apex, which measured 4 mm, and one in right apex, which measured 6 mm.

The patient was referred to cardiothoracic surgeons for a possible lobectomy, but the patient declined to have surgery. She was then referred to the oncologists. She underwent repeat CT and positron-emission tomography (PET) scans, which showed that her cancer had continued to shrink. On CT, there was an 11-mm reduction, and on PET, an 18-mm reduction. The left apical nodule had resolved, and the right upper lobe nodule was reduced in size.

The patient was offered stereotactic ablative radiotherapy, but she declined this treatment. Because she had refused all standard therapies, a decision was made to “watch and wait.” The patient underwent regular CT surveillance.

Over the course of 2.5 years, the tumor continued to regress. By February 2021, it had shrunk to 10 mm, which represents an overall reduction of 76% in maximum axial diameter. The average rate of reduction was 2.4% per month throughout the monitoring period.

“This case was brought to the attention of the local lung MDT [multidisciplinary team] in February 2019 when the serial imaging showed a reduction in tumor size despite having received no conventional treatment for her lung cancer,” write the authors.

The patient was contacted to discuss her results. She revealed that she was using CBD oil and that she had started taking it in August 2018. No changes had been made in her prescription medications, diet, and lifestyle, and she continued to smoke a pack of cigarettes every week.

“I was not very interested in traditional cancer treatments,” the patient said, “as I was worried about the risks of surgery, and I saw my late husband suffer through the side effects of radiotherapy. My relative suggested that I should try ‘cannabidiol (CBD) oil’ to treat my cancer, and I have been taking it regularly ever since. I am ‘over the moon’ with my cancer shrinking, which I believe was caused by the ‘CBD oil’. I am tolerating it very well and I intend to take this treatment indefinitely.”

The source of the CBD oil was outside the United Kingdom. The main active ingredients, according to her supplier, were Δ9-tetrahydrocannabinol (THC), at 19.5%, CBD, at 20.05%, and tetrahydrocannabinolic acid, at 23.8%.

“The product used by this patient reportedly contained high levels of THC (the intoxicating component of cannabis) and was sourced from outside the U.K.,” commented Tom Freeman, PhD, senior lecturer and director of the Addiction and Mental Health Group, University of Bath, United Kingdom. “This type of product is very different to most CBD oils, which predominantly contain CBD. Unlike prescribed medicines, CBD wellness products lack assurance of quality, safety, or efficacy and should not be used for medicinal purposes.”

The authors have disclosed no relevant financial relationships. Dr. Nutt chairs the scientific committee of the charity Drug Science, which receives unrestricted educational grants from some medical cannabis companies. Dr. Ernst and Dr. Freeman have disclosed no relevant financial relationships.

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

A case report describes the dramatic shrinkage of a tumor to a quarter of its original size in a patient with non–small cell lung cancer (NSCLC) who had declined conventional treatment, continued smoking, and who later revealed that she was ingesting cannabidiol (CBD) oil.

The patient was an 80-year-old woman.

At diagnosis, the tumor measured 41 mm, and there was no evidence of local or further spread. Hence, it was suitable for a standard treatment regimen of surgery, chemotherapy, and radiotherapy, note the authors.

The patient declined conventional treatment. She underwent monitoring with regular CT scans every 3–6 months.

After 2.5 years, the CT scans showed that the tumor had shrunk to 10 mm.

The patient then disclosed that she had been ingesting CBD oil, which had been suggested to her by a family member. It was taken orally about two to three times a day.

Details of the case were published on October 14 in BMJ Case Reports.

“We are aware of the limitations of this case report,” write the authors, led by Kah Ling Liew, MD, of Watford General Hospital, Watford, United Kingdom.

“Although there appears to be a relationship between the intake of ‘CBD oil’ and the observed tumour regression, we are unable to conclusively confirm that the tumour regression is due to the patient taking ‘CBD oil,’ ” they comment.

The team also notes that there are similar case reports in the medical literature.

Both points were emphasized by experts reacting to the publication via the UK Science Media Center.

“This is one of many such promising single case reports of medical cannabis self-treatment for various cancers,” said David Nutt, DM, FRCP, FRCPsych, the Edmond J. Safra Chair in Neuropsychopharmacology, Imperial College London, United Kingdom. “Such case reports are biologically credible given the adaptogenic nature of the endocannabinoid system.”

He noted that a “case report itself is not sufficient to give any form of proof that one thing caused the other -- we need trials for that. There are some controlled trials already started and more are required to properly explore the potential of medical cannabis in a range of cancers.”

Another expert, Edzard Ernst, MD, PhD, professor emeritus of complementary medicine, University of Exeter, United Kingdom, pointed out that in animal models, cannabinoids have reduced the size of prostate cancer tumors. “Previous case reports have yielded encouraging findings also in human cancers,” he noted. He too said that further study is needed.

“Case reports cannot be considered to be reliable evidence, and there are currently no data from rigorous clinical trials to suggest that cannabis products will alter the natural history of any cancer,”Dr. Ernst said.

Patient declined recommended treatment

The patient initially presented with a persistent cough that did not resolve with antibiotic therapy. She has a history of mild chronic obstructive pulmonary disease, osteoarthritis, and hypertension. She is a current smoker with a 68 pack-year history of smoking. She has no history of alcohol consumption and is taking several prescription medications.

After an initial CT scan, she underwent a CT-guided lung biopsy and was diagnosed with NSCLC (TNM stage T2bN0Mx). Further analysis of the tumor tissue showed that it was negative for ALK and EGFR mutations. PDL1 was expressed by <1% of the tumor cells. No distant metastases were detected.

A subsequent CT scan revealed that the main tumor in her right middle lobe had shrunk from 41 mm to 33 mm. There were new bilateral upper lobe nodules, one in the left apex, which measured 4 mm, and one in right apex, which measured 6 mm.

The patient was referred to cardiothoracic surgeons for a possible lobectomy, but the patient declined to have surgery. She was then referred to the oncologists. She underwent repeat CT and positron-emission tomography (PET) scans, which showed that her cancer had continued to shrink. On CT, there was an 11-mm reduction, and on PET, an 18-mm reduction. The left apical nodule had resolved, and the right upper lobe nodule was reduced in size.

The patient was offered stereotactic ablative radiotherapy, but she declined this treatment. Because she had refused all standard therapies, a decision was made to “watch and wait.” The patient underwent regular CT surveillance.

Over the course of 2.5 years, the tumor continued to regress. By February 2021, it had shrunk to 10 mm, which represents an overall reduction of 76% in maximum axial diameter. The average rate of reduction was 2.4% per month throughout the monitoring period.

“This case was brought to the attention of the local lung MDT [multidisciplinary team] in February 2019 when the serial imaging showed a reduction in tumor size despite having received no conventional treatment for her lung cancer,” write the authors.

The patient was contacted to discuss her results. She revealed that she was using CBD oil and that she had started taking it in August 2018. No changes had been made in her prescription medications, diet, and lifestyle, and she continued to smoke a pack of cigarettes every week.

“I was not very interested in traditional cancer treatments,” the patient said, “as I was worried about the risks of surgery, and I saw my late husband suffer through the side effects of radiotherapy. My relative suggested that I should try ‘cannabidiol (CBD) oil’ to treat my cancer, and I have been taking it regularly ever since. I am ‘over the moon’ with my cancer shrinking, which I believe was caused by the ‘CBD oil’. I am tolerating it very well and I intend to take this treatment indefinitely.”

The source of the CBD oil was outside the United Kingdom. The main active ingredients, according to her supplier, were Δ9-tetrahydrocannabinol (THC), at 19.5%, CBD, at 20.05%, and tetrahydrocannabinolic acid, at 23.8%.

“The product used by this patient reportedly contained high levels of THC (the intoxicating component of cannabis) and was sourced from outside the U.K.,” commented Tom Freeman, PhD, senior lecturer and director of the Addiction and Mental Health Group, University of Bath, United Kingdom. “This type of product is very different to most CBD oils, which predominantly contain CBD. Unlike prescribed medicines, CBD wellness products lack assurance of quality, safety, or efficacy and should not be used for medicinal purposes.”

The authors have disclosed no relevant financial relationships. Dr. Nutt chairs the scientific committee of the charity Drug Science, which receives unrestricted educational grants from some medical cannabis companies. Dr. Ernst and Dr. Freeman have disclosed no relevant financial relationships.

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

Wide-area transepithelial sampling with 3D (WATS-3D) analysis increased detection of dysplasia when used as an adjunct to the Seattle forceps biopsy protocol in patients with Barrett’s esophagus, according to a recent meta-analysis. While the findings demonstrate potential for increased dysplasia detection, the analysis failed to identify the clinical significance of this detection.

©Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

Despite its ability to evaluate Barrett’s esophagus segments and examine targeted biopsies of mucosal abnormalities, the Seattle protocol is primarily limited by lack of adherence and increased risk of sampling error. “Moreover, the rates of ‘missed’ dysplasia and EAC [esophageal adenocarcinoma] remain high, with up to a quarter of all EAC being ‘missed,’ ” wrote study authors Don Codipilly, MD, of the Mayo Clinic, and colleagues. The report is in Gastrointestinal Endoscopy.

There are challenges associated with the Seattle protocol, specifically poor protocol adherence and missed identification of subtle abnormalities potentially harboring dysplasia. In contrast, the novel WATS-3D may overcome issues related to sampling error due to its ability to obtain higher proportions of Barrett’s esophagus mucosa through the use of a brush-only technique. According to the researchers, previous studies suggest WATS-3D may increase dysplasia yield by approximately 40% compared with conventional surveillance methods.

To gauge the incremental yield of WATS-3D for dysplasia detection compared with the Seattle forceps biopsy protocol, Dr. Codipilly and colleagues performed a systematic review and meta-analysis of seven studies using the two techniques from 2000 to 2020. The researchers defined “incremental yield” of detected dysplasia as a composite of indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). They also compared the two surveillance techniques in terms of incremental yields of HGD/EAC, as well as the rate of reconfirmation of WATS-3D dysplasia on subsequent forceps biopsies.

The seven studies in the final analysis included a pooled cohort of 3,206 patients. According to the meta-analysis, forceps biopsies diagnosed dysplasia in 15.9% (95% confidence interval, 5.4-30.5) of all cases, while the incremental yield of WATS-3D was 7.2% (95% CI, 3.9-11.5). In the pooled analysis of six studies that reported the secondary outcomes, forceps biopsies diagnosed HGD/EAC in 2.3% (95% CI, 0.6-5.1) of patients, while the incremental yield with WATS-3D was 2.1% (95% CI, 0.4-5.3). The researchers point out that WATS-3D was negative in 62.5% of cases where forceps biopsies detected dysplasia. Reports from two of the studies reconfirmed WATS-3D dysplasia with forceps biopsies histology in 20 patients.

“Based on these findings, it cannot be recommended to replace the Seattle Protocol but instead to use both techniques in conjunction to detect dysplasia most effectively,” Omar Awais, DO, assistant professor of surgery in the Department of Cardiothoracic Surgery at the University of Pittsburgh School of Medicine, said in an email to this news organization.

Dr. Awais, who was not involved in the meta-analysis, suggests further prospective, randomized studies are needed to confirm the results. “Additionally, we will also need studies to show cost-effectiveness for using WATS-3D in addition to Seattle protocol, as these may help verify WATS-3D dysplasia by standard endoscopic protocol and show we are not missing dysplasia using the technique,” he said.

Felice H. Schnoll-Sussman, MD, professor of clinical medicine and director of the Jay Monahan Center for Gastrointestinal Health at New York–Presbyterian Hospital/Weill Medical College, added that the meta-analysis “adds to our understanding” of the place of WATS as an adjunct approach in dysplasia detection. “In spite of the rigid selection of studies, this analysis also leaves us with questions about the overall utility of WATS given the lack of follow-up cases where dysplasia was only identified on the WATS brush as well as the overall cost-effectiveness of this approach,” she said.

Dr. Schnoll-Sussman, who was not involved in the study conducted by Dr. Codipilly and colleagues, told this news organization that one of the issues with the WATS brush is obtaining adequate sampling, which may impede adherence. “Attention has to be paid to sampling all quadrants with the brush, which at times may be challenging, especially in esophagi that are tortuous, angulated, or dilated,” she explained. “Like with any endoscopic technique, care must be taken to obtain high-yield sampling.”

Dr. Schnoll-Sussman noted that the subtle, small areas of denuded mucosa left where the brush has made appropriate contact with the mucosa should be appreciated during sampling. “Taking one’s time to sample the esophageal lining – a major reason for missed lesions in the Seattle protocol – can also become an issue with WATS,” she added.

The study researchers reported conflicts of interest with several pharmaceutical companies. No funding was reported for the study. Dr. Awais and Dr. Schnoll-Sussman had no conflicts to disclose.

Help your patients better understand the risks, testing and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE. 

Wide-area transepithelial sampling with 3D (WATS-3D) analysis increased detection of dysplasia when used as an adjunct to the Seattle forceps biopsy protocol in patients with Barrett’s esophagus, according to a recent meta-analysis. While the findings demonstrate potential for increased dysplasia detection, the analysis failed to identify the clinical significance of this detection.

©Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

Despite its ability to evaluate Barrett’s esophagus segments and examine targeted biopsies of mucosal abnormalities, the Seattle protocol is primarily limited by lack of adherence and increased risk of sampling error. “Moreover, the rates of ‘missed’ dysplasia and EAC [esophageal adenocarcinoma] remain high, with up to a quarter of all EAC being ‘missed,’ ” wrote study authors Don Codipilly, MD, of the Mayo Clinic, and colleagues. The report is in Gastrointestinal Endoscopy.

There are challenges associated with the Seattle protocol, specifically poor protocol adherence and missed identification of subtle abnormalities potentially harboring dysplasia. In contrast, the novel WATS-3D may overcome issues related to sampling error due to its ability to obtain higher proportions of Barrett’s esophagus mucosa through the use of a brush-only technique. According to the researchers, previous studies suggest WATS-3D may increase dysplasia yield by approximately 40% compared with conventional surveillance methods.

To gauge the incremental yield of WATS-3D for dysplasia detection compared with the Seattle forceps biopsy protocol, Dr. Codipilly and colleagues performed a systematic review and meta-analysis of seven studies using the two techniques from 2000 to 2020. The researchers defined “incremental yield” of detected dysplasia as a composite of indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). They also compared the two surveillance techniques in terms of incremental yields of HGD/EAC, as well as the rate of reconfirmation of WATS-3D dysplasia on subsequent forceps biopsies.

The seven studies in the final analysis included a pooled cohort of 3,206 patients. According to the meta-analysis, forceps biopsies diagnosed dysplasia in 15.9% (95% confidence interval, 5.4-30.5) of all cases, while the incremental yield of WATS-3D was 7.2% (95% CI, 3.9-11.5). In the pooled analysis of six studies that reported the secondary outcomes, forceps biopsies diagnosed HGD/EAC in 2.3% (95% CI, 0.6-5.1) of patients, while the incremental yield with WATS-3D was 2.1% (95% CI, 0.4-5.3). The researchers point out that WATS-3D was negative in 62.5% of cases where forceps biopsies detected dysplasia. Reports from two of the studies reconfirmed WATS-3D dysplasia with forceps biopsies histology in 20 patients.

“Based on these findings, it cannot be recommended to replace the Seattle Protocol but instead to use both techniques in conjunction to detect dysplasia most effectively,” Omar Awais, DO, assistant professor of surgery in the Department of Cardiothoracic Surgery at the University of Pittsburgh School of Medicine, said in an email to this news organization.

Dr. Awais, who was not involved in the meta-analysis, suggests further prospective, randomized studies are needed to confirm the results. “Additionally, we will also need studies to show cost-effectiveness for using WATS-3D in addition to Seattle protocol, as these may help verify WATS-3D dysplasia by standard endoscopic protocol and show we are not missing dysplasia using the technique,” he said.

Felice H. Schnoll-Sussman, MD, professor of clinical medicine and director of the Jay Monahan Center for Gastrointestinal Health at New York–Presbyterian Hospital/Weill Medical College, added that the meta-analysis “adds to our understanding” of the place of WATS as an adjunct approach in dysplasia detection. “In spite of the rigid selection of studies, this analysis also leaves us with questions about the overall utility of WATS given the lack of follow-up cases where dysplasia was only identified on the WATS brush as well as the overall cost-effectiveness of this approach,” she said.

Dr. Schnoll-Sussman, who was not involved in the study conducted by Dr. Codipilly and colleagues, told this news organization that one of the issues with the WATS brush is obtaining adequate sampling, which may impede adherence. “Attention has to be paid to sampling all quadrants with the brush, which at times may be challenging, especially in esophagi that are tortuous, angulated, or dilated,” she explained. “Like with any endoscopic technique, care must be taken to obtain high-yield sampling.”

Dr. Schnoll-Sussman noted that the subtle, small areas of denuded mucosa left where the brush has made appropriate contact with the mucosa should be appreciated during sampling. “Taking one’s time to sample the esophageal lining – a major reason for missed lesions in the Seattle protocol – can also become an issue with WATS,” she added.

The study researchers reported conflicts of interest with several pharmaceutical companies. No funding was reported for the study. Dr. Awais and Dr. Schnoll-Sussman had no conflicts to disclose.

Help your patients better understand the risks, testing and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE. 

Wide-area transepithelial sampling with 3D (WATS-3D) analysis increased detection of dysplasia when used as an adjunct to the Seattle forceps biopsy protocol in patients with Barrett’s esophagus, according to a recent meta-analysis. While the findings demonstrate potential for increased dysplasia detection, the analysis failed to identify the clinical significance of this detection.

©Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

Despite its ability to evaluate Barrett’s esophagus segments and examine targeted biopsies of mucosal abnormalities, the Seattle protocol is primarily limited by lack of adherence and increased risk of sampling error. “Moreover, the rates of ‘missed’ dysplasia and EAC [esophageal adenocarcinoma] remain high, with up to a quarter of all EAC being ‘missed,’ ” wrote study authors Don Codipilly, MD, of the Mayo Clinic, and colleagues. The report is in Gastrointestinal Endoscopy.

There are challenges associated with the Seattle protocol, specifically poor protocol adherence and missed identification of subtle abnormalities potentially harboring dysplasia. In contrast, the novel WATS-3D may overcome issues related to sampling error due to its ability to obtain higher proportions of Barrett’s esophagus mucosa through the use of a brush-only technique. According to the researchers, previous studies suggest WATS-3D may increase dysplasia yield by approximately 40% compared with conventional surveillance methods.

To gauge the incremental yield of WATS-3D for dysplasia detection compared with the Seattle forceps biopsy protocol, Dr. Codipilly and colleagues performed a systematic review and meta-analysis of seven studies using the two techniques from 2000 to 2020. The researchers defined “incremental yield” of detected dysplasia as a composite of indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). They also compared the two surveillance techniques in terms of incremental yields of HGD/EAC, as well as the rate of reconfirmation of WATS-3D dysplasia on subsequent forceps biopsies.

The seven studies in the final analysis included a pooled cohort of 3,206 patients. According to the meta-analysis, forceps biopsies diagnosed dysplasia in 15.9% (95% confidence interval, 5.4-30.5) of all cases, while the incremental yield of WATS-3D was 7.2% (95% CI, 3.9-11.5). In the pooled analysis of six studies that reported the secondary outcomes, forceps biopsies diagnosed HGD/EAC in 2.3% (95% CI, 0.6-5.1) of patients, while the incremental yield with WATS-3D was 2.1% (95% CI, 0.4-5.3). The researchers point out that WATS-3D was negative in 62.5% of cases where forceps biopsies detected dysplasia. Reports from two of the studies reconfirmed WATS-3D dysplasia with forceps biopsies histology in 20 patients.

“Based on these findings, it cannot be recommended to replace the Seattle Protocol but instead to use both techniques in conjunction to detect dysplasia most effectively,” Omar Awais, DO, assistant professor of surgery in the Department of Cardiothoracic Surgery at the University of Pittsburgh School of Medicine, said in an email to this news organization.

Dr. Awais, who was not involved in the meta-analysis, suggests further prospective, randomized studies are needed to confirm the results. “Additionally, we will also need studies to show cost-effectiveness for using WATS-3D in addition to Seattle protocol, as these may help verify WATS-3D dysplasia by standard endoscopic protocol and show we are not missing dysplasia using the technique,” he said.

Felice H. Schnoll-Sussman, MD, professor of clinical medicine and director of the Jay Monahan Center for Gastrointestinal Health at New York–Presbyterian Hospital/Weill Medical College, added that the meta-analysis “adds to our understanding” of the place of WATS as an adjunct approach in dysplasia detection. “In spite of the rigid selection of studies, this analysis also leaves us with questions about the overall utility of WATS given the lack of follow-up cases where dysplasia was only identified on the WATS brush as well as the overall cost-effectiveness of this approach,” she said.

Dr. Schnoll-Sussman, who was not involved in the study conducted by Dr. Codipilly and colleagues, told this news organization that one of the issues with the WATS brush is obtaining adequate sampling, which may impede adherence. “Attention has to be paid to sampling all quadrants with the brush, which at times may be challenging, especially in esophagi that are tortuous, angulated, or dilated,” she explained. “Like with any endoscopic technique, care must be taken to obtain high-yield sampling.”

Dr. Schnoll-Sussman noted that the subtle, small areas of denuded mucosa left where the brush has made appropriate contact with the mucosa should be appreciated during sampling. “Taking one’s time to sample the esophageal lining – a major reason for missed lesions in the Seattle protocol – can also become an issue with WATS,” she added.

The study researchers reported conflicts of interest with several pharmaceutical companies. No funding was reported for the study. Dr. Awais and Dr. Schnoll-Sussman had no conflicts to disclose.

Help your patients better understand the risks, testing and treatment options for Barrett’s esophagus by sharing education from the AGA GI Patient Center: www.gastro.org/BE. 

The Barcelona baseline risk score predicted progression of multiple sclerosis (MS) in patients by assigning them to low-, medium-, and high-risk groups. The high-risk group had the shortest time to progression to an Expanded Disability Status Score (EDSS) of 3.0, and were also more likely to progress by MRI and quality of life measures.

The ranking is based on sex, age at the first clinically isolated syndrome, CIS topography, the number of T2 lesions, and the presence of infratentorial and spinal cord lesions, contrast-enhancing lesions, and oligoclonal bands.

“What we wanted to do is merge all of the different prognostic variables for one single patient into one single score,” said Mar Tintoré, MD, PhD, in an interview. Dr. Tintoré is a professor of neurology at Vall d’Hebron University Hospital in Barcelona and a senior consultant at the Multiple Sclerosis Centre of Catalonia (Cemcat). Dr. Tintoré presented the results of the study at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

The three groups had different outcomes in MRI, clinical factors, and MRI scans, and quality of life outcomes over the course of their disease. “So this is a confirmation that this classification at baseline is really meaningful,” Dr. Tintoré said in an interview.

She attributed the success of the model to its reliance on multiple factors, but it is also designed to be simple to use. “We have been trying to use it with simple factors, [information] that you always have, like age, sex, gender, number of lesions, and topography of the region. Everybody has this information at their desk.”
 

Proof of concept

The study validates the approach that neurologists already utilize, according to Patricia Coyle, MD, who moderated the session. “I think the prospective study is a really unique and powerful concept,” said Dr. Coyle, who is a professor of neurology, vice chair of neurology, and director of the Stony Brook (N.Y.) Comprehensive Care Center.

The new study “kind of confirmed their concept of the initial rating, judging long-term disability progression measures in subsets. They also looked at brain atrophy, they looked at gray-matter atrophy, and that also traveled with these three different groups of severity. So it kind of gives value to looking at prognostic indicators at a first attack,” said Dr. Coyle.

The results also validate the Barcelona group’s heavy emphasis on MRI, which Dr. Coyle pointed out is common practice. “If the brain MRI looks very bad, if there are a lot of spinal cord lesions, then that’s somebody we’re much more worried about.”

Once the model is confirmed in other cohorts, the researchers plan to release the model as a generally available algorithm that clinicians could use to help manage patients. Dr. Tintoré pointed out the debate over when to begin a patient on high-efficacy disease-modifying therapies. That choice depends on a lot of factors, including patient choice, safety, and comorbidities. “But knowing that your patient is at risk of having a bad prognosis is something that is helpful” in that decision-making process, she said.
 

Predicting time to EDSS 3.0

The researchers used the Barcelona CIS cohort to build a Weibull survival regression in order to estimate the median time to EDSS 3.0. The model produced three categories with widely divergent predicted times from CIS to EDSS 3.0: low risk, medium risk, and high risk.

In the current report, the researchers compared the model to a “360 degree” measure of measures in 1,308 patients, including clinical milestones (McDonald 2017 MS, confirmed secondary progressive MS, progression independent of relapse activity [PIRA], EDSS disability, number of T2 MRI lesions and brain atrophy, and Patient Reported Outcomes for MS [walking speed, manual dexterity, processing speed, and contrast sensitivity]).

At 30 years after CIS, the risk of reaching EDSS 3.0 was higher in the medium risk (hazard ratio, 3.0 versus low risk) and in the high risk group (HR, 8.3 versus low risk). At 10 years, the low risk group had a 40% risk of fulfilling McDonald 2017 criteria, versus 89% in the intermediate group, and 98% in the high risk group. A similar relationship was seen for SPMS (1%, 8%, 16%) and PIRA (17%, 26%, 35%).

At 10 years, the estimated accumulated T2 lesions was 7 in the low-risk group (95% CI, 5-9), 15 in the medium-risk group (95% CI, 12-17), and 21 in the high-risk group (95% CI, 15-27).

Compared with the low- and medium-risk groups, the high-risk group had lower brain parenchymal fraction and gray-matter fraction at 5 years. They also experienced higher stigma, had worse perception of upper and lower limb function as measured by Neuro QoL, and had worse cognitive performance.

Dr. Tintoré has received compensation for consulting services and speaking honoraria from Aimirall, Bayer Schering Pharma, Biogen-Idec, Genzyme, Janssen, Merck-Serono, Novartis, Roche, Sanofi-Aventis, Teva Pharmaceuticals, and Viela Bio. Dr. Coyle has no relevant disclosures.

The Barcelona baseline risk score predicted progression of multiple sclerosis (MS) in patients by assigning them to low-, medium-, and high-risk groups. The high-risk group had the shortest time to progression to an Expanded Disability Status Score (EDSS) of 3.0, and were also more likely to progress by MRI and quality of life measures.

The ranking is based on sex, age at the first clinically isolated syndrome, CIS topography, the number of T2 lesions, and the presence of infratentorial and spinal cord lesions, contrast-enhancing lesions, and oligoclonal bands.

“What we wanted to do is merge all of the different prognostic variables for one single patient into one single score,” said Mar Tintoré, MD, PhD, in an interview. Dr. Tintoré is a professor of neurology at Vall d’Hebron University Hospital in Barcelona and a senior consultant at the Multiple Sclerosis Centre of Catalonia (Cemcat). Dr. Tintoré presented the results of the study at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

The three groups had different outcomes in MRI, clinical factors, and MRI scans, and quality of life outcomes over the course of their disease. “So this is a confirmation that this classification at baseline is really meaningful,” Dr. Tintoré said in an interview.

She attributed the success of the model to its reliance on multiple factors, but it is also designed to be simple to use. “We have been trying to use it with simple factors, [information] that you always have, like age, sex, gender, number of lesions, and topography of the region. Everybody has this information at their desk.”
 

Proof of concept

The study validates the approach that neurologists already utilize, according to Patricia Coyle, MD, who moderated the session. “I think the prospective study is a really unique and powerful concept,” said Dr. Coyle, who is a professor of neurology, vice chair of neurology, and director of the Stony Brook (N.Y.) Comprehensive Care Center.

The new study “kind of confirmed their concept of the initial rating, judging long-term disability progression measures in subsets. They also looked at brain atrophy, they looked at gray-matter atrophy, and that also traveled with these three different groups of severity. So it kind of gives value to looking at prognostic indicators at a first attack,” said Dr. Coyle.

The results also validate the Barcelona group’s heavy emphasis on MRI, which Dr. Coyle pointed out is common practice. “If the brain MRI looks very bad, if there are a lot of spinal cord lesions, then that’s somebody we’re much more worried about.”

Once the model is confirmed in other cohorts, the researchers plan to release the model as a generally available algorithm that clinicians could use to help manage patients. Dr. Tintoré pointed out the debate over when to begin a patient on high-efficacy disease-modifying therapies. That choice depends on a lot of factors, including patient choice, safety, and comorbidities. “But knowing that your patient is at risk of having a bad prognosis is something that is helpful” in that decision-making process, she said.
 

Predicting time to EDSS 3.0

The researchers used the Barcelona CIS cohort to build a Weibull survival regression in order to estimate the median time to EDSS 3.0. The model produced three categories with widely divergent predicted times from CIS to EDSS 3.0: low risk, medium risk, and high risk.

In the current report, the researchers compared the model to a “360 degree” measure of measures in 1,308 patients, including clinical milestones (McDonald 2017 MS, confirmed secondary progressive MS, progression independent of relapse activity [PIRA], EDSS disability, number of T2 MRI lesions and brain atrophy, and Patient Reported Outcomes for MS [walking speed, manual dexterity, processing speed, and contrast sensitivity]).

At 30 years after CIS, the risk of reaching EDSS 3.0 was higher in the medium risk (hazard ratio, 3.0 versus low risk) and in the high risk group (HR, 8.3 versus low risk). At 10 years, the low risk group had a 40% risk of fulfilling McDonald 2017 criteria, versus 89% in the intermediate group, and 98% in the high risk group. A similar relationship was seen for SPMS (1%, 8%, 16%) and PIRA (17%, 26%, 35%).

At 10 years, the estimated accumulated T2 lesions was 7 in the low-risk group (95% CI, 5-9), 15 in the medium-risk group (95% CI, 12-17), and 21 in the high-risk group (95% CI, 15-27).

Compared with the low- and medium-risk groups, the high-risk group had lower brain parenchymal fraction and gray-matter fraction at 5 years. They also experienced higher stigma, had worse perception of upper and lower limb function as measured by Neuro QoL, and had worse cognitive performance.

Dr. Tintoré has received compensation for consulting services and speaking honoraria from Aimirall, Bayer Schering Pharma, Biogen-Idec, Genzyme, Janssen, Merck-Serono, Novartis, Roche, Sanofi-Aventis, Teva Pharmaceuticals, and Viela Bio. Dr. Coyle has no relevant disclosures.

The Barcelona baseline risk score predicted progression of multiple sclerosis (MS) in patients by assigning them to low-, medium-, and high-risk groups. The high-risk group had the shortest time to progression to an Expanded Disability Status Score (EDSS) of 3.0, and were also more likely to progress by MRI and quality of life measures.

The ranking is based on sex, age at the first clinically isolated syndrome, CIS topography, the number of T2 lesions, and the presence of infratentorial and spinal cord lesions, contrast-enhancing lesions, and oligoclonal bands.

“What we wanted to do is merge all of the different prognostic variables for one single patient into one single score,” said Mar Tintoré, MD, PhD, in an interview. Dr. Tintoré is a professor of neurology at Vall d’Hebron University Hospital in Barcelona and a senior consultant at the Multiple Sclerosis Centre of Catalonia (Cemcat). Dr. Tintoré presented the results of the study at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

The three groups had different outcomes in MRI, clinical factors, and MRI scans, and quality of life outcomes over the course of their disease. “So this is a confirmation that this classification at baseline is really meaningful,” Dr. Tintoré said in an interview.

She attributed the success of the model to its reliance on multiple factors, but it is also designed to be simple to use. “We have been trying to use it with simple factors, [information] that you always have, like age, sex, gender, number of lesions, and topography of the region. Everybody has this information at their desk.”
 

Proof of concept

The study validates the approach that neurologists already utilize, according to Patricia Coyle, MD, who moderated the session. “I think the prospective study is a really unique and powerful concept,” said Dr. Coyle, who is a professor of neurology, vice chair of neurology, and director of the Stony Brook (N.Y.) Comprehensive Care Center.

The new study “kind of confirmed their concept of the initial rating, judging long-term disability progression measures in subsets. They also looked at brain atrophy, they looked at gray-matter atrophy, and that also traveled with these three different groups of severity. So it kind of gives value to looking at prognostic indicators at a first attack,” said Dr. Coyle.

The results also validate the Barcelona group’s heavy emphasis on MRI, which Dr. Coyle pointed out is common practice. “If the brain MRI looks very bad, if there are a lot of spinal cord lesions, then that’s somebody we’re much more worried about.”

Once the model is confirmed in other cohorts, the researchers plan to release the model as a generally available algorithm that clinicians could use to help manage patients. Dr. Tintoré pointed out the debate over when to begin a patient on high-efficacy disease-modifying therapies. That choice depends on a lot of factors, including patient choice, safety, and comorbidities. “But knowing that your patient is at risk of having a bad prognosis is something that is helpful” in that decision-making process, she said.
 

Predicting time to EDSS 3.0

The researchers used the Barcelona CIS cohort to build a Weibull survival regression in order to estimate the median time to EDSS 3.0. The model produced three categories with widely divergent predicted times from CIS to EDSS 3.0: low risk, medium risk, and high risk.

In the current report, the researchers compared the model to a “360 degree” measure of measures in 1,308 patients, including clinical milestones (McDonald 2017 MS, confirmed secondary progressive MS, progression independent of relapse activity [PIRA], EDSS disability, number of T2 MRI lesions and brain atrophy, and Patient Reported Outcomes for MS [walking speed, manual dexterity, processing speed, and contrast sensitivity]).

At 30 years after CIS, the risk of reaching EDSS 3.0 was higher in the medium risk (hazard ratio, 3.0 versus low risk) and in the high risk group (HR, 8.3 versus low risk). At 10 years, the low risk group had a 40% risk of fulfilling McDonald 2017 criteria, versus 89% in the intermediate group, and 98% in the high risk group. A similar relationship was seen for SPMS (1%, 8%, 16%) and PIRA (17%, 26%, 35%).

At 10 years, the estimated accumulated T2 lesions was 7 in the low-risk group (95% CI, 5-9), 15 in the medium-risk group (95% CI, 12-17), and 21 in the high-risk group (95% CI, 15-27).

Compared with the low- and medium-risk groups, the high-risk group had lower brain parenchymal fraction and gray-matter fraction at 5 years. They also experienced higher stigma, had worse perception of upper and lower limb function as measured by Neuro QoL, and had worse cognitive performance.

Dr. Tintoré has received compensation for consulting services and speaking honoraria from Aimirall, Bayer Schering Pharma, Biogen-Idec, Genzyme, Janssen, Merck-Serono, Novartis, Roche, Sanofi-Aventis, Teva Pharmaceuticals, and Viela Bio. Dr. Coyle has no relevant disclosures.

Add-on treatment with dupilumab may improve lung function in children aged 6-11 years with uncontrolled moderate to severe type 2 inflammatory asthma, results from a randomized, placebo-controlled, phase 3 study show.

Improvements in lung function parameters were observed as early as 2 weeks and persisted over the 52-week treatment period among children in the LIBERTY ASTHMA VOYAGE study, according to investigator Leonard B. Bacharier, MD, of Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn.

“Dupilumab led to clinically meaningful rapid and sustained improvements in lung function parameters,” Dr. Bacharier said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

The improvements in forced expiratory volume in 1 second (FEV₁) and other measures reported for children with moderate to severe asthma who have the type 2 phenotype, which is the most common driver of pediatric asthma, according to Dr. Bacharier.

“Many children with moderate to severe asthma have abnormal lung function, and this can be a risk factor for future lung disease in adulthood,” Dr. Bacharier said in his presentation.
 

The VOYAGE continues

The findings presented at the meeting build on another report earlier this year from the LIBERTY ASTHMA VOYAGE study demonstrating that add-on dupilumab treatment led to a significant improvement versus placebo in FEV₁ up to 12 weeks.

“We now have a long term data on this drug as well, showing its efficacy over a period of time,” said Muhammad Adrish, MD, MBA, FCCP, associate professor of pulmonary, critical care and sleep medicine at Baylor College of Medicine, Houston.

“I think that’s pretty exciting, and that’s another step towards precision medicine in treatment of asthma,” Dr. Adrish, who is Vice-Chair of CHEST’s Airways Disorders NetWork Steering Committee and was not involved in the study.

Dupilumab received Food and Drug Administration approval in 2018 as add-on maintenance therapy for the treatment of patients aged 12 years or older with moderate to severe asthma that has an eosinophilic phenotype or that is dependent on oral corticosteroid treatment.

In March 2021, Sanofi and Regeneron announced that the FDA had accepted for review a supplemental Biologics License Application for dupilumab as an add-on treatment in children aged 6-11 years with uncontrolled moderate to severe asthma.

That sBLA is supported by data from the LIBERTY ASTHMA VOYAGE study, Sanofi and Regeneron said.

In results of the phase 3 study that Dr. Bacharier presented in May at the American Thoracic Society International Conference, add-on dupilumab dosed every 2 weeks significant improved percent predicted prebronchodilator FEV₁ by an additional 5.21 percentage points versus placebo at week 12.
 

Dupilumab and the type 2 phenotype

The new data reported at the CHEST meeting come from a prespecified analysis evaluating the impact of dupilumab on lung function over a 52-week treatment period in patients with a T2 inflammatory asthma phenotype.

“Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and -13, key and central drivers of T2 inflammation in multiple diseases,” Dr. Bacharier and coinvestigators reported in their study abstract.

Of 408 patients in the study, 350 met the T2 phenotype criteria, including 236 in the dupilumab arm and 114 in the placebo arm.

Patients met T2 phenotype criteria if they had blood eosinophils of at least 150 cells/mcL or fractional exhaled nitric oxide FeNO of at least 20 parts per billion at baseline, investigators said.

Dr. Bacharier and coinvestigators reported on several different endpoints, including absolute and percent predicted prebronchodilator FEV₁, percent predicted postbronchodilator FEV₁, prebronchodilator forced expiratory flow at 25%-75% of pulmonary volume (FEF_25%-75%), and forced vital capacity (FVC).

Dupilumab, when compared with placebo, significantly improved prebronchodilator FEV₁ in pediatric patients with uncontrolled moderate to severe type 2 asthma, according to Dr. Bacharier.

“Patients receiving dupilumab experienced rapid improvements by week 2, and this was sustained for up to 52 weeks,” he said.

The prebronchodilator FEV₁ improved from baseline for dupilumab versus placebo, with a least squares mean difference of 0.06 L at week 2, which reached 0.17 L by week 52, according to their data. Similarly, postbronchodilator FEV₁ improved from baseline for dupilumab, with a least square mean difference versus placebo of 0.09 L at week 52.

Dupilumab compared to placebo also significantly improved percent predicted FEF_25%-75%, and percent predicted FVC over the 52-week treatment period, according to Dr. Bacharier.

“Dupilumab led to significant, rapid, and sustained improvements in multiple aspects of lung function in children aged 6-11 years,” Dr. Bacharier added in a CHEST press release that described the findings.

The LIBERTY ASTHMA VOYAGE study was sponsored by Sanofi and Regeneron Pharmaceuticals. Dr. Bacharier provided disclosures related to AstraZeneca, GlaxoSmithKline, Regeneron Pharmaceuticals, Sanofi, CF Foundation, DBV Technologies, NIH, and Vectura.

Add-on treatment with dupilumab may improve lung function in children aged 6-11 years with uncontrolled moderate to severe type 2 inflammatory asthma, results from a randomized, placebo-controlled, phase 3 study show.

Improvements in lung function parameters were observed as early as 2 weeks and persisted over the 52-week treatment period among children in the LIBERTY ASTHMA VOYAGE study, according to investigator Leonard B. Bacharier, MD, of Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn.

“Dupilumab led to clinically meaningful rapid and sustained improvements in lung function parameters,” Dr. Bacharier said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

The improvements in forced expiratory volume in 1 second (FEV₁) and other measures reported for children with moderate to severe asthma who have the type 2 phenotype, which is the most common driver of pediatric asthma, according to Dr. Bacharier.

“Many children with moderate to severe asthma have abnormal lung function, and this can be a risk factor for future lung disease in adulthood,” Dr. Bacharier said in his presentation.
 

The VOYAGE continues

The findings presented at the meeting build on another report earlier this year from the LIBERTY ASTHMA VOYAGE study demonstrating that add-on dupilumab treatment led to a significant improvement versus placebo in FEV₁ up to 12 weeks.

“We now have a long term data on this drug as well, showing its efficacy over a period of time,” said Muhammad Adrish, MD, MBA, FCCP, associate professor of pulmonary, critical care and sleep medicine at Baylor College of Medicine, Houston.

“I think that’s pretty exciting, and that’s another step towards precision medicine in treatment of asthma,” Dr. Adrish, who is Vice-Chair of CHEST’s Airways Disorders NetWork Steering Committee and was not involved in the study.

Dupilumab received Food and Drug Administration approval in 2018 as add-on maintenance therapy for the treatment of patients aged 12 years or older with moderate to severe asthma that has an eosinophilic phenotype or that is dependent on oral corticosteroid treatment.

In March 2021, Sanofi and Regeneron announced that the FDA had accepted for review a supplemental Biologics License Application for dupilumab as an add-on treatment in children aged 6-11 years with uncontrolled moderate to severe asthma.

That sBLA is supported by data from the LIBERTY ASTHMA VOYAGE study, Sanofi and Regeneron said.

In results of the phase 3 study that Dr. Bacharier presented in May at the American Thoracic Society International Conference, add-on dupilumab dosed every 2 weeks significant improved percent predicted prebronchodilator FEV₁ by an additional 5.21 percentage points versus placebo at week 12.
 

Dupilumab and the type 2 phenotype

The new data reported at the CHEST meeting come from a prespecified analysis evaluating the impact of dupilumab on lung function over a 52-week treatment period in patients with a T2 inflammatory asthma phenotype.

“Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and -13, key and central drivers of T2 inflammation in multiple diseases,” Dr. Bacharier and coinvestigators reported in their study abstract.

Of 408 patients in the study, 350 met the T2 phenotype criteria, including 236 in the dupilumab arm and 114 in the placebo arm.

Patients met T2 phenotype criteria if they had blood eosinophils of at least 150 cells/mcL or fractional exhaled nitric oxide FeNO of at least 20 parts per billion at baseline, investigators said.

Dr. Bacharier and coinvestigators reported on several different endpoints, including absolute and percent predicted prebronchodilator FEV₁, percent predicted postbronchodilator FEV₁, prebronchodilator forced expiratory flow at 25%-75% of pulmonary volume (FEF_25%-75%), and forced vital capacity (FVC).

Dupilumab, when compared with placebo, significantly improved prebronchodilator FEV₁ in pediatric patients with uncontrolled moderate to severe type 2 asthma, according to Dr. Bacharier.

“Patients receiving dupilumab experienced rapid improvements by week 2, and this was sustained for up to 52 weeks,” he said.

The prebronchodilator FEV₁ improved from baseline for dupilumab versus placebo, with a least squares mean difference of 0.06 L at week 2, which reached 0.17 L by week 52, according to their data. Similarly, postbronchodilator FEV₁ improved from baseline for dupilumab, with a least square mean difference versus placebo of 0.09 L at week 52.

Dupilumab compared to placebo also significantly improved percent predicted FEF_25%-75%, and percent predicted FVC over the 52-week treatment period, according to Dr. Bacharier.

“Dupilumab led to significant, rapid, and sustained improvements in multiple aspects of lung function in children aged 6-11 years,” Dr. Bacharier added in a CHEST press release that described the findings.

The LIBERTY ASTHMA VOYAGE study was sponsored by Sanofi and Regeneron Pharmaceuticals. Dr. Bacharier provided disclosures related to AstraZeneca, GlaxoSmithKline, Regeneron Pharmaceuticals, Sanofi, CF Foundation, DBV Technologies, NIH, and Vectura.

Add-on treatment with dupilumab may improve lung function in children aged 6-11 years with uncontrolled moderate to severe type 2 inflammatory asthma, results from a randomized, placebo-controlled, phase 3 study show.

Improvements in lung function parameters were observed as early as 2 weeks and persisted over the 52-week treatment period among children in the LIBERTY ASTHMA VOYAGE study, according to investigator Leonard B. Bacharier, MD, of Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn.

“Dupilumab led to clinically meaningful rapid and sustained improvements in lung function parameters,” Dr. Bacharier said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.

The improvements in forced expiratory volume in 1 second (FEV₁) and other measures reported for children with moderate to severe asthma who have the type 2 phenotype, which is the most common driver of pediatric asthma, according to Dr. Bacharier.

“Many children with moderate to severe asthma have abnormal lung function, and this can be a risk factor for future lung disease in adulthood,” Dr. Bacharier said in his presentation.
 

The VOYAGE continues

The findings presented at the meeting build on another report earlier this year from the LIBERTY ASTHMA VOYAGE study demonstrating that add-on dupilumab treatment led to a significant improvement versus placebo in FEV₁ up to 12 weeks.

“We now have a long term data on this drug as well, showing its efficacy over a period of time,” said Muhammad Adrish, MD, MBA, FCCP, associate professor of pulmonary, critical care and sleep medicine at Baylor College of Medicine, Houston.

“I think that’s pretty exciting, and that’s another step towards precision medicine in treatment of asthma,” Dr. Adrish, who is Vice-Chair of CHEST’s Airways Disorders NetWork Steering Committee and was not involved in the study.

Dupilumab received Food and Drug Administration approval in 2018 as add-on maintenance therapy for the treatment of patients aged 12 years or older with moderate to severe asthma that has an eosinophilic phenotype or that is dependent on oral corticosteroid treatment.

In March 2021, Sanofi and Regeneron announced that the FDA had accepted for review a supplemental Biologics License Application for dupilumab as an add-on treatment in children aged 6-11 years with uncontrolled moderate to severe asthma.

That sBLA is supported by data from the LIBERTY ASTHMA VOYAGE study, Sanofi and Regeneron said.

In results of the phase 3 study that Dr. Bacharier presented in May at the American Thoracic Society International Conference, add-on dupilumab dosed every 2 weeks significant improved percent predicted prebronchodilator FEV₁ by an additional 5.21 percentage points versus placebo at week 12.
 

Dupilumab and the type 2 phenotype

The new data reported at the CHEST meeting come from a prespecified analysis evaluating the impact of dupilumab on lung function over a 52-week treatment period in patients with a T2 inflammatory asthma phenotype.

“Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and -13, key and central drivers of T2 inflammation in multiple diseases,” Dr. Bacharier and coinvestigators reported in their study abstract.

Of 408 patients in the study, 350 met the T2 phenotype criteria, including 236 in the dupilumab arm and 114 in the placebo arm.

Patients met T2 phenotype criteria if they had blood eosinophils of at least 150 cells/mcL or fractional exhaled nitric oxide FeNO of at least 20 parts per billion at baseline, investigators said.

Dr. Bacharier and coinvestigators reported on several different endpoints, including absolute and percent predicted prebronchodilator FEV₁, percent predicted postbronchodilator FEV₁, prebronchodilator forced expiratory flow at 25%-75% of pulmonary volume (FEF_25%-75%), and forced vital capacity (FVC).

Dupilumab, when compared with placebo, significantly improved prebronchodilator FEV₁ in pediatric patients with uncontrolled moderate to severe type 2 asthma, according to Dr. Bacharier.

“Patients receiving dupilumab experienced rapid improvements by week 2, and this was sustained for up to 52 weeks,” he said.

The prebronchodilator FEV₁ improved from baseline for dupilumab versus placebo, with a least squares mean difference of 0.06 L at week 2, which reached 0.17 L by week 52, according to their data. Similarly, postbronchodilator FEV₁ improved from baseline for dupilumab, with a least square mean difference versus placebo of 0.09 L at week 52.

Dupilumab compared to placebo also significantly improved percent predicted FEF_25%-75%, and percent predicted FVC over the 52-week treatment period, according to Dr. Bacharier.

“Dupilumab led to significant, rapid, and sustained improvements in multiple aspects of lung function in children aged 6-11 years,” Dr. Bacharier added in a CHEST press release that described the findings.

The LIBERTY ASTHMA VOYAGE study was sponsored by Sanofi and Regeneron Pharmaceuticals. Dr. Bacharier provided disclosures related to AstraZeneca, GlaxoSmithKline, Regeneron Pharmaceuticals, Sanofi, CF Foundation, DBV Technologies, NIH, and Vectura.

Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.

Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.

“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.

In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.

Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.

Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.

Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.

“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.

The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.

Birth location should be an informed decision

The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.

“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.

“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.

“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.

Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
 

Patient selection is key to successful community birth

The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.

“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.

Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.

“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.

“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.

“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.

The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.

Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.

Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.

“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.

In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.

Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.

Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.

Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.

“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.

The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.

Birth location should be an informed decision

The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.

“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.

“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.

“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.

Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
 

Patient selection is key to successful community birth

The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.

“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.

Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.

“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.

“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.

“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.

The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.

Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.

Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.

“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.

In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.

Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.

Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.

Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.

“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.

The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.

Birth location should be an informed decision

The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.

“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.

“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.

“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.

Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
 

Patient selection is key to successful community birth

The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.

“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.

Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.

“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.

“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.

“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.

The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.

Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.

Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.

Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
 

You could be immediately terminated without notice

One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.

“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”

What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.

The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
 

No protections if you’re let go through no fault of your own

You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.

In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.

What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”

Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.

In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
 

Employer could unilaterally alter your compensation

Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.

Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.

What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”

“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
 

Accelerating notice for without-cause terminations

Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.

Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.

“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.

Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.

What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
 

You could be assigned to far-off locations

As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.

Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.

What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.

You could end up working too many off-hours

“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”

What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.

If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
 

You wouldn’t be able to work nearby if you left the job

Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.

“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”

Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.

For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.

What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
 

You might end up with too much call

Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.

Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.

But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.

Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.

What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
 

Physician must pay for reimbursement claw-backs by payers

When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?

In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.

What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
 

Some work may be outside of your subspecialty

In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.

For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.

What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.

What the employer promised isn’t in the contract

“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”

Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.

For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.

What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
 

Contract is simply accepted as is

“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.

But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.

The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”

Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.

“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”

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

Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.

Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.

Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
 

You could be immediately terminated without notice

One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.

“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”

What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.

The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
 

No protections if you’re let go through no fault of your own

You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.

In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.

What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”

Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.

In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
 

Employer could unilaterally alter your compensation

Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.

Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.

What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”

“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
 

Accelerating notice for without-cause terminations

Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.

Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.

“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.

Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.

What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
 

You could be assigned to far-off locations

As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.

Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.

What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.

You could end up working too many off-hours

“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”

What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.

If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
 

You wouldn’t be able to work nearby if you left the job

Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.

“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”

Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.

For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.

What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
 

You might end up with too much call

Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.

Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.

But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.

Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.

What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
 

Physician must pay for reimbursement claw-backs by payers

When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?

In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.

What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
 

Some work may be outside of your subspecialty

In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.

For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.

What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.

What the employer promised isn’t in the contract

“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”

Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.

For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.

What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
 

Contract is simply accepted as is

“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.

But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.

The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”

Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.

“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”

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

Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.

Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.

Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
 

You could be immediately terminated without notice

One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.

“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”

What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.

The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
 

No protections if you’re let go through no fault of your own

You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.

In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.

What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”

Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.

In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
 

Employer could unilaterally alter your compensation

Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.

Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.

What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”

“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
 

Accelerating notice for without-cause terminations

Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.

Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.

“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.

Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.

What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
 

You could be assigned to far-off locations

As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.

Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.

What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.

You could end up working too many off-hours

“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”

What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.

If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
 

You wouldn’t be able to work nearby if you left the job

Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.

“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”

Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.

For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.

What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
 

You might end up with too much call

Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.

Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.

But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.

Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.

What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
 

Physician must pay for reimbursement claw-backs by payers

When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?

In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.

What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
 

Some work may be outside of your subspecialty

In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.

For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.

What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.

What the employer promised isn’t in the contract

“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”

Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.

For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.

What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
 

Contract is simply accepted as is

“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.

But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.

The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”

Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.

“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”

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

New classes of antimigraine drugs demonstrate efficacy and improved tolerability for patients with chronic migraine, a new systematic review and meta-analysis finds.

“[T]he lack of cardiovascular risks of these new classes of migraine-specific treatments may provide alternative treatment options for individuals for whom currently available acute treatments have failed or for those with cardiovascular contraindications,” write lead author Chun-Pai Yang, MD, PhD, of Taichung (Taiwan) Veterans General Hospital and colleagues, in the paper, published online in JAMA Network Open.
 

Methods

The new study compared the outcomes for acute migraine management using the ditan, lasmiditan (a 5-hydroxytryptamine [5HT]1F–receptor agonist), and the two gepants, rimegepant, and ubrogepant (calcitonin gene–related peptide [CGRP] antagonists), with standard triptan (selective 5-HT1B/1D–receptor agonist) therapy.

The researchers evaluated 64 double-blind randomized clinical trials which included 46,442 patients, the majority of whom (74%-87%) were women with an age range of 36-43 years.

The primary outcome evaluated was the odds ratio for freedom from pain at 2 hours after a single dose and secondary outcomes were the OR for pain relief at 2 hours following a dose, as well as any adverse events.
 

Results

Dr. Yang and colleagues found that virtually all medications with widespread clinical use, regardless of class, were associated with higher ORs for pain freedom when compared with placebo.

Compared to ditan and gepant agents, however, triptans were associated with significantly higher ORs for pain freedom. The odds ratio ranges were 1.72-3.40 for lasmiditan, 1.58-3.13 for rimegepant, and 1.54-3.05 for ubrogepant.

With respect to pain relief at 2 hours, while all medications were more effective than placebo, triptans were associated with higher ORs when compared with the other drug classes: lasmiditan (range: OR, 1.46; 95% confidence interval, 1.09-1.96 to OR, 3.31; 95% CI, 2.41-4.55), rimegepant (range: OR, 1.33; 95% CI, 1.01-1.76 to OR, 3.01; 95% CI, 2.33-3.88), and ubrogepant (range: OR, 1.38; 95% CI, 1.02-1.88 to OR, 3.13; 95% CI, 2.35-4.15)

When assessing tolerability, the researchers found that overall, triptans were associated with the higher ORs for any adverse events (AE) with a trend of dose-response relationship. Lasmiditan (in the ditan class) was associated with the highest risk for AEs among all treatments. Most of the AEs were mild to moderate and included chest pain, tightness, heaviness, and pressure.

Dr. Yang and colleagues note that, “although these two new classes of antimigraine drugs may not be as efficacious as triptans, these novel abortive agents without cardiovascular risks might offer an alternative to current specific migraine treatments for patients at risk of cardiovascular disease.”
 

Balancing efficacy and tolerability

“When choosing an acute medication for a patient there is always a balance between efficacy and tolerability,” headache specialist and associate director of North Shore Headache and Spine Lauren Natbony, MD, said in an interview.

“A medication can only be effective if a patient is able to tolerate it and will actually use it,” Dr. Natbony said.

With respect to the current review, Dr. Natbony pointed out, “response to acute therapy can differ between migraine attacks and may be based on variables not controlled for, such as how early in an attack the medication was taken, associated symptoms such as nausea that may make oral medications less efficacious, etc.”

The authors acknowledge that the focus on short-term responses and AEs after a single dose is a limitation of the study. They also pointed out what they considered to be a strength of the study, which was its network meta-analysis design. According to the authors, this design allowed for “multiple direct and indirect comparisons, ranking the efficacy and safety of individual pharmacologic interventions and providing more precise estimates than those of RCTs and traditional meta-analysis.”

Funding for this study was provided through grants from the Ministry of Science and Technology, Taiwan; the Brain Research Center; and National Yang Ming Chiao Tung University.

Dr. Yang has received personal fees and grants from various pharmaceutical companies. He has also received grants from the Taiwan Ministry of Technology and Science, the Brain Research Center, National Yang Ming Chiao Tung University, and Taipei Veterans General Hospital outside the submitted work. The other authors and Dr. Natbony disclosed no relevant financial relationships.

New classes of antimigraine drugs demonstrate efficacy and improved tolerability for patients with chronic migraine, a new systematic review and meta-analysis finds.

“[T]he lack of cardiovascular risks of these new classes of migraine-specific treatments may provide alternative treatment options for individuals for whom currently available acute treatments have failed or for those with cardiovascular contraindications,” write lead author Chun-Pai Yang, MD, PhD, of Taichung (Taiwan) Veterans General Hospital and colleagues, in the paper, published online in JAMA Network Open.
 

Methods

The new study compared the outcomes for acute migraine management using the ditan, lasmiditan (a 5-hydroxytryptamine [5HT]1F–receptor agonist), and the two gepants, rimegepant, and ubrogepant (calcitonin gene–related peptide [CGRP] antagonists), with standard triptan (selective 5-HT1B/1D–receptor agonist) therapy.

The researchers evaluated 64 double-blind randomized clinical trials which included 46,442 patients, the majority of whom (74%-87%) were women with an age range of 36-43 years.

The primary outcome evaluated was the odds ratio for freedom from pain at 2 hours after a single dose and secondary outcomes were the OR for pain relief at 2 hours following a dose, as well as any adverse events.
 

Results

Dr. Yang and colleagues found that virtually all medications with widespread clinical use, regardless of class, were associated with higher ORs for pain freedom when compared with placebo.

Compared to ditan and gepant agents, however, triptans were associated with significantly higher ORs for pain freedom. The odds ratio ranges were 1.72-3.40 for lasmiditan, 1.58-3.13 for rimegepant, and 1.54-3.05 for ubrogepant.

With respect to pain relief at 2 hours, while all medications were more effective than placebo, triptans were associated with higher ORs when compared with the other drug classes: lasmiditan (range: OR, 1.46; 95% confidence interval, 1.09-1.96 to OR, 3.31; 95% CI, 2.41-4.55), rimegepant (range: OR, 1.33; 95% CI, 1.01-1.76 to OR, 3.01; 95% CI, 2.33-3.88), and ubrogepant (range: OR, 1.38; 95% CI, 1.02-1.88 to OR, 3.13; 95% CI, 2.35-4.15)

When assessing tolerability, the researchers found that overall, triptans were associated with the higher ORs for any adverse events (AE) with a trend of dose-response relationship. Lasmiditan (in the ditan class) was associated with the highest risk for AEs among all treatments. Most of the AEs were mild to moderate and included chest pain, tightness, heaviness, and pressure.

Dr. Yang and colleagues note that, “although these two new classes of antimigraine drugs may not be as efficacious as triptans, these novel abortive agents without cardiovascular risks might offer an alternative to current specific migraine treatments for patients at risk of cardiovascular disease.”
 

Balancing efficacy and tolerability

“When choosing an acute medication for a patient there is always a balance between efficacy and tolerability,” headache specialist and associate director of North Shore Headache and Spine Lauren Natbony, MD, said in an interview.

“A medication can only be effective if a patient is able to tolerate it and will actually use it,” Dr. Natbony said.

With respect to the current review, Dr. Natbony pointed out, “response to acute therapy can differ between migraine attacks and may be based on variables not controlled for, such as how early in an attack the medication was taken, associated symptoms such as nausea that may make oral medications less efficacious, etc.”

The authors acknowledge that the focus on short-term responses and AEs after a single dose is a limitation of the study. They also pointed out what they considered to be a strength of the study, which was its network meta-analysis design. According to the authors, this design allowed for “multiple direct and indirect comparisons, ranking the efficacy and safety of individual pharmacologic interventions and providing more precise estimates than those of RCTs and traditional meta-analysis.”

Funding for this study was provided through grants from the Ministry of Science and Technology, Taiwan; the Brain Research Center; and National Yang Ming Chiao Tung University.

Dr. Yang has received personal fees and grants from various pharmaceutical companies. He has also received grants from the Taiwan Ministry of Technology and Science, the Brain Research Center, National Yang Ming Chiao Tung University, and Taipei Veterans General Hospital outside the submitted work. The other authors and Dr. Natbony disclosed no relevant financial relationships.

New classes of antimigraine drugs demonstrate efficacy and improved tolerability for patients with chronic migraine, a new systematic review and meta-analysis finds.

“[T]he lack of cardiovascular risks of these new classes of migraine-specific treatments may provide alternative treatment options for individuals for whom currently available acute treatments have failed or for those with cardiovascular contraindications,” write lead author Chun-Pai Yang, MD, PhD, of Taichung (Taiwan) Veterans General Hospital and colleagues, in the paper, published online in JAMA Network Open.
 

Methods

The new study compared the outcomes for acute migraine management using the ditan, lasmiditan (a 5-hydroxytryptamine [5HT]1F–receptor agonist), and the two gepants, rimegepant, and ubrogepant (calcitonin gene–related peptide [CGRP] antagonists), with standard triptan (selective 5-HT1B/1D–receptor agonist) therapy.

The researchers evaluated 64 double-blind randomized clinical trials which included 46,442 patients, the majority of whom (74%-87%) were women with an age range of 36-43 years.

The primary outcome evaluated was the odds ratio for freedom from pain at 2 hours after a single dose and secondary outcomes were the OR for pain relief at 2 hours following a dose, as well as any adverse events.
 

Results

Dr. Yang and colleagues found that virtually all medications with widespread clinical use, regardless of class, were associated with higher ORs for pain freedom when compared with placebo.

Compared to ditan and gepant agents, however, triptans were associated with significantly higher ORs for pain freedom. The odds ratio ranges were 1.72-3.40 for lasmiditan, 1.58-3.13 for rimegepant, and 1.54-3.05 for ubrogepant.

With respect to pain relief at 2 hours, while all medications were more effective than placebo, triptans were associated with higher ORs when compared with the other drug classes: lasmiditan (range: OR, 1.46; 95% confidence interval, 1.09-1.96 to OR, 3.31; 95% CI, 2.41-4.55), rimegepant (range: OR, 1.33; 95% CI, 1.01-1.76 to OR, 3.01; 95% CI, 2.33-3.88), and ubrogepant (range: OR, 1.38; 95% CI, 1.02-1.88 to OR, 3.13; 95% CI, 2.35-4.15)

When assessing tolerability, the researchers found that overall, triptans were associated with the higher ORs for any adverse events (AE) with a trend of dose-response relationship. Lasmiditan (in the ditan class) was associated with the highest risk for AEs among all treatments. Most of the AEs were mild to moderate and included chest pain, tightness, heaviness, and pressure.

Dr. Yang and colleagues note that, “although these two new classes of antimigraine drugs may not be as efficacious as triptans, these novel abortive agents without cardiovascular risks might offer an alternative to current specific migraine treatments for patients at risk of cardiovascular disease.”
 

Balancing efficacy and tolerability

“When choosing an acute medication for a patient there is always a balance between efficacy and tolerability,” headache specialist and associate director of North Shore Headache and Spine Lauren Natbony, MD, said in an interview.

“A medication can only be effective if a patient is able to tolerate it and will actually use it,” Dr. Natbony said.

With respect to the current review, Dr. Natbony pointed out, “response to acute therapy can differ between migraine attacks and may be based on variables not controlled for, such as how early in an attack the medication was taken, associated symptoms such as nausea that may make oral medications less efficacious, etc.”

The authors acknowledge that the focus on short-term responses and AEs after a single dose is a limitation of the study. They also pointed out what they considered to be a strength of the study, which was its network meta-analysis design. According to the authors, this design allowed for “multiple direct and indirect comparisons, ranking the efficacy and safety of individual pharmacologic interventions and providing more precise estimates than those of RCTs and traditional meta-analysis.”

Funding for this study was provided through grants from the Ministry of Science and Technology, Taiwan; the Brain Research Center; and National Yang Ming Chiao Tung University.

Dr. Yang has received personal fees and grants from various pharmaceutical companies. He has also received grants from the Taiwan Ministry of Technology and Science, the Brain Research Center, National Yang Ming Chiao Tung University, and Taipei Veterans General Hospital outside the submitted work. The other authors and Dr. Natbony disclosed no relevant financial relationships.