Will Pass

A recent study that reported no association between race and in-hospital mortality among patients with COVID-19 failed to capture broader health care inequities, according to a leading expert.

During an AGA FORWARD Program webinar, Darrell Gray II, MD, deputy director of the Center for Cancer Health Equity at Ohio State University in Columbus, noted that the study by Baligh R. Yehia, MD, and colleagues had several important limitations: specifically, a lack of data from before or after hospitalization, flawed neighborhood deprivation indices, and poorly characterized comorbidities.

While Dr. Yehia and colleagues described these limitations in their publication, Dr. Gray suggested that future studies evaluating race and health outcomes need to be “deliberate and intentional with collecting data.”

According to Dr. Gray, statistics from the Centers for Disease Control and Prevention and the APM Research Lab paint a more accurate picture of health care inequities. The CDC, for instance, reports that people who are Black are nearly five times as likely to be hospitalized for COVID-19, and approximately twice as likely to die from the disease, compared with those who are White. The APM Research Lab reports an even more striking relative mortality rate for Black Americans – almost four times higher than that of White Americans.

“People of color have been disproportionately impacted by COVID-19, whether it be by cases, hospitalizations, or deaths,” Dr. Gray said. “We have to think about why that is, and what has led to this.”

Dr. Gray emphasized that poorer outcomes among people of color are “not necessarily biological.”

“It’s the environment and social constructs that contribute to why there’s a disproportionate burden of chronic disease and why there’s a disproportionate burden of COVID-19,” he said.

According to Dr. Gray, disparate health care outcomes can be traced back to social determinants of health, which he and his colleagues highlighted in a June comment published in Nature Reviews Gastroenterology & Hepatology.

“Although much attention has focused on the high burden of chronic disease among [people of color], which predisposes them to poor outcomes if they acquire COVID-19, there is less recognition of the nonmedical health-related social needs and social determinants of health that represent the root causes of such health disparities,” they wrote.

Social determinants of health include an array of population factors, including economic stability, social and community context, neighborhood and environment, education, and access to health care.

For each, Dr. Gray encouraged comprehensive and nuanced assessment.

“Is there access to health care?” Dr. Gray asked. “Not just access in the sense of having insurance – certainly that’s a benefit – but if someone has insurance, can they get to where the health center is? Or is that something they might have to catch three buses and a cab to get to?”

Dr. Gray said that such obstacles are not outside the scope of the medical community.

“This is not beyond our responsibility ... to address social determinants of health,” Dr. Gray said.

When asked by a webinar attendee how the medical community can tackle racism, Dr. Gray offered several practical steps to move forward.

First, he suggested that clinicians and researchers listen to affected patient populations.

“Many of us, including clinicians, have been privileged to have their blinders on, if you will, to issues of racism that have been affecting our patients for a long time,” he said.

Second, Dr. Gray encouraged those who have learned to teach others.

“You need to start teaching your peers, your colleagues, your family, and friends about how racism affects patient outcomes.”

Third, he recommended that clinicians incorporate these lessons into routine practice, whether in a private or an academic setting.

“Are there ways in which you can refer patients to address social determinants of health? Are you capturing that information in your check-in materials?” Dr. Gray asked. “If you’re an investigator, when you’re doing research – whether it’s health disparities research or other – are you looking at your research through a health equity lens? Are you asking questions about social determinants of health?”

Finally, Dr. Gray called for stronger community engagement during design and conduction of clinical trials.

“People don’t care how much you know until they know how much you care,” he said. “And they won’t know how much you care unless you’re visible, and unless you’re there, and these are sustainable relationships.”

The FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

A recent study that reported no association between race and in-hospital mortality among patients with COVID-19 failed to capture broader health care inequities, according to a leading expert.

During an AGA FORWARD Program webinar, Darrell Gray II, MD, deputy director of the Center for Cancer Health Equity at Ohio State University in Columbus, noted that the study by Baligh R. Yehia, MD, and colleagues had several important limitations: specifically, a lack of data from before or after hospitalization, flawed neighborhood deprivation indices, and poorly characterized comorbidities.

While Dr. Yehia and colleagues described these limitations in their publication, Dr. Gray suggested that future studies evaluating race and health outcomes need to be “deliberate and intentional with collecting data.”

According to Dr. Gray, statistics from the Centers for Disease Control and Prevention and the APM Research Lab paint a more accurate picture of health care inequities. The CDC, for instance, reports that people who are Black are nearly five times as likely to be hospitalized for COVID-19, and approximately twice as likely to die from the disease, compared with those who are White. The APM Research Lab reports an even more striking relative mortality rate for Black Americans – almost four times higher than that of White Americans.

“People of color have been disproportionately impacted by COVID-19, whether it be by cases, hospitalizations, or deaths,” Dr. Gray said. “We have to think about why that is, and what has led to this.”

Dr. Gray emphasized that poorer outcomes among people of color are “not necessarily biological.”

“It’s the environment and social constructs that contribute to why there’s a disproportionate burden of chronic disease and why there’s a disproportionate burden of COVID-19,” he said.

According to Dr. Gray, disparate health care outcomes can be traced back to social determinants of health, which he and his colleagues highlighted in a June comment published in Nature Reviews Gastroenterology & Hepatology.

“Although much attention has focused on the high burden of chronic disease among [people of color], which predisposes them to poor outcomes if they acquire COVID-19, there is less recognition of the nonmedical health-related social needs and social determinants of health that represent the root causes of such health disparities,” they wrote.

Social determinants of health include an array of population factors, including economic stability, social and community context, neighborhood and environment, education, and access to health care.

For each, Dr. Gray encouraged comprehensive and nuanced assessment.

“Is there access to health care?” Dr. Gray asked. “Not just access in the sense of having insurance – certainly that’s a benefit – but if someone has insurance, can they get to where the health center is? Or is that something they might have to catch three buses and a cab to get to?”

Dr. Gray said that such obstacles are not outside the scope of the medical community.

“This is not beyond our responsibility ... to address social determinants of health,” Dr. Gray said.

When asked by a webinar attendee how the medical community can tackle racism, Dr. Gray offered several practical steps to move forward.

First, he suggested that clinicians and researchers listen to affected patient populations.

“Many of us, including clinicians, have been privileged to have their blinders on, if you will, to issues of racism that have been affecting our patients for a long time,” he said.

Second, Dr. Gray encouraged those who have learned to teach others.

“You need to start teaching your peers, your colleagues, your family, and friends about how racism affects patient outcomes.”

Third, he recommended that clinicians incorporate these lessons into routine practice, whether in a private or an academic setting.

“Are there ways in which you can refer patients to address social determinants of health? Are you capturing that information in your check-in materials?” Dr. Gray asked. “If you’re an investigator, when you’re doing research – whether it’s health disparities research or other – are you looking at your research through a health equity lens? Are you asking questions about social determinants of health?”

Finally, Dr. Gray called for stronger community engagement during design and conduction of clinical trials.

“People don’t care how much you know until they know how much you care,” he said. “And they won’t know how much you care unless you’re visible, and unless you’re there, and these are sustainable relationships.”

The FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

A recent study that reported no association between race and in-hospital mortality among patients with COVID-19 failed to capture broader health care inequities, according to a leading expert.

During an AGA FORWARD Program webinar, Darrell Gray II, MD, deputy director of the Center for Cancer Health Equity at Ohio State University in Columbus, noted that the study by Baligh R. Yehia, MD, and colleagues had several important limitations: specifically, a lack of data from before or after hospitalization, flawed neighborhood deprivation indices, and poorly characterized comorbidities.

While Dr. Yehia and colleagues described these limitations in their publication, Dr. Gray suggested that future studies evaluating race and health outcomes need to be “deliberate and intentional with collecting data.”

According to Dr. Gray, statistics from the Centers for Disease Control and Prevention and the APM Research Lab paint a more accurate picture of health care inequities. The CDC, for instance, reports that people who are Black are nearly five times as likely to be hospitalized for COVID-19, and approximately twice as likely to die from the disease, compared with those who are White. The APM Research Lab reports an even more striking relative mortality rate for Black Americans – almost four times higher than that of White Americans.

“People of color have been disproportionately impacted by COVID-19, whether it be by cases, hospitalizations, or deaths,” Dr. Gray said. “We have to think about why that is, and what has led to this.”

Dr. Gray emphasized that poorer outcomes among people of color are “not necessarily biological.”

“It’s the environment and social constructs that contribute to why there’s a disproportionate burden of chronic disease and why there’s a disproportionate burden of COVID-19,” he said.

According to Dr. Gray, disparate health care outcomes can be traced back to social determinants of health, which he and his colleagues highlighted in a June comment published in Nature Reviews Gastroenterology & Hepatology.

“Although much attention has focused on the high burden of chronic disease among [people of color], which predisposes them to poor outcomes if they acquire COVID-19, there is less recognition of the nonmedical health-related social needs and social determinants of health that represent the root causes of such health disparities,” they wrote.

Social determinants of health include an array of population factors, including economic stability, social and community context, neighborhood and environment, education, and access to health care.

For each, Dr. Gray encouraged comprehensive and nuanced assessment.

“Is there access to health care?” Dr. Gray asked. “Not just access in the sense of having insurance – certainly that’s a benefit – but if someone has insurance, can they get to where the health center is? Or is that something they might have to catch three buses and a cab to get to?”

Dr. Gray said that such obstacles are not outside the scope of the medical community.

“This is not beyond our responsibility ... to address social determinants of health,” Dr. Gray said.

When asked by a webinar attendee how the medical community can tackle racism, Dr. Gray offered several practical steps to move forward.

First, he suggested that clinicians and researchers listen to affected patient populations.

“Many of us, including clinicians, have been privileged to have their blinders on, if you will, to issues of racism that have been affecting our patients for a long time,” he said.

Second, Dr. Gray encouraged those who have learned to teach others.

“You need to start teaching your peers, your colleagues, your family, and friends about how racism affects patient outcomes.”

Third, he recommended that clinicians incorporate these lessons into routine practice, whether in a private or an academic setting.

“Are there ways in which you can refer patients to address social determinants of health? Are you capturing that information in your check-in materials?” Dr. Gray asked. “If you’re an investigator, when you’re doing research – whether it’s health disparities research or other – are you looking at your research through a health equity lens? Are you asking questions about social determinants of health?”

Finally, Dr. Gray called for stronger community engagement during design and conduction of clinical trials.

“People don’t care how much you know until they know how much you care,” he said. “And they won’t know how much you care unless you’re visible, and unless you’re there, and these are sustainable relationships.”

The FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

Suspension of disease screening and nonurgent procedures because of the COVID-19 pandemic will negatively impact long-term outcomes of GI and liver disease, and people of color will be disproportionately affected, according to a leading expert.

Novel, multipronged approaches are needed to overcome widening disparities in gastroenterology and hepatology, said Rachel Issaka, MD, of Fred Hutchinson Cancer Research Center in Seattle.

“The COVID-19 pandemic has led to unprecedented drops in breast, colorectal, and cervical cancer screenings,” Dr. Issaka said during an AGA FORWARD Program webinar. Screening rates for these diseases are down 83%-90%, she said.

“Certainly this creates a backlog of cancer screenings that need to occur, which poses very significant challenges for health systems as they’re adapting to this new state of health care that we have to provide,” Dr. Issaka said.

During her presentation, Dr. Issaka first addressed pandemic-related issues in colorectal cancer (CRC).

The sudden decrease in colonoscopies has already affected diagnoses, she said, as 32% fewer cases of CRC were diagnosed in April 2020 compared with April 2019, a finding that is “obviously very concerning.” All downstream effects remain to be seen; however, one estimate suggests that over the next decade, delayed screening may lead to an additional 4,500 deaths from CRC.

“These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest,” Dr. Issaka wrote, as coauthor of a study published in Gastrointestinal Endoscopy.

Dr. Issaka and colleagues predict that the pandemic will likely worsen “persistent CRC disparities” in African-American and Hispanic communities, including relatively decreased screening participation, delayed follow-up of abnormal stool results, limited community-based research and partnerships, and limited community engagement and advocacy.

“COVID-19 related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations,” wrote Dr. Issaka and colleagues.

Dr. Issaka described similar issues in hepatology. She referred to a recent opinion article by Tapper and colleagues, which predicted that the COVID-19 pandemic will impact patients with liver disease in three waves: first, by delaying liver transplants, elective procedures, imaging, and routine patient follow-up; second, by increasing emergent decompensations, transplant wait-list dropouts, and care deferrals; and third, by losing patients to follow-up, resulting in missed diagnoses, incomplete cancer screening, and progressive disease.

“This could disproportionately impact Black, Hispanic, and Native-American populations, who may have already had difficulty accessing [liver care],” Dr. Issaka said.

To mitigate growing disparities, Dr. Issaka proposed a variety of strategies for CRC and liver disease.

For CRC screening, Dr. Issaka suggested noninvasive modalities, including mailed fecal immunochemical tests (FIT), with focused follow-up on patients with highest FIT values. For those conducting CRC research, Dr. Issaka recommended using accessible technology, engaging with community partners, providing incentives where appropriate, and other methods. For cirrhosis care, Dr. Issaka suggested that practitioners turn to telehealth and remote care, including weight monitoring, cognitive function testing, home medication delivery, and online education.

More broadly, Dr. Issaka called for universal health insurance not associated with employment, research funding for health disparities, sustainable employment wages, climate justice, desegregation of housing, and universal broadband Internet.

“The solutions to these problems are multipronged,” Dr. Issaka said. “Some will happen locally; for instance, well-executed planning around telehealth. Some will happen at the state level through opportunities like advocacy or even just reaching out to your own [congressional representative]. And then some will also happen programmatically – How can we as a health system begin to leverage something like mailed FIT?”

Finally, Dr. Issaka suggested that tools from another branch of science can help improve screening rates.

“We don’t, in medicine, tap into the benefits of behavioral psychology enough,” she said. “That’s a great discipline with really great tools that we can all use.”

Dr. Issaka described the power of community, in that people are more likely to undergo screening if they know how many others in their community are also being screened.

“I think as much as we can gather those kinds of data and share those with individuals to provide reassurance about the safety and importance of screening, I think [that] will help,” she said.

The AGA FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (DK118761). Dr. Issaka has no conflicts of interest.

SOURCES: Issaka. AGA FORWARD Program Webinar. 2020 Aug 27; Balzora et al. Gastrointestinal Endoscopy. 2020 June 20. doi: 10.1016/j.gie.2020.06.042; Tapper et al. Journal of Hepatology. 2020 Apr 13. doi: 10.1016/j.jhep.2020.04.005.

Suspension of disease screening and nonurgent procedures because of the COVID-19 pandemic will negatively impact long-term outcomes of GI and liver disease, and people of color will be disproportionately affected, according to a leading expert.

Novel, multipronged approaches are needed to overcome widening disparities in gastroenterology and hepatology, said Rachel Issaka, MD, of Fred Hutchinson Cancer Research Center in Seattle.

“The COVID-19 pandemic has led to unprecedented drops in breast, colorectal, and cervical cancer screenings,” Dr. Issaka said during an AGA FORWARD Program webinar. Screening rates for these diseases are down 83%-90%, she said.

“Certainly this creates a backlog of cancer screenings that need to occur, which poses very significant challenges for health systems as they’re adapting to this new state of health care that we have to provide,” Dr. Issaka said.

During her presentation, Dr. Issaka first addressed pandemic-related issues in colorectal cancer (CRC).

The sudden decrease in colonoscopies has already affected diagnoses, she said, as 32% fewer cases of CRC were diagnosed in April 2020 compared with April 2019, a finding that is “obviously very concerning.” All downstream effects remain to be seen; however, one estimate suggests that over the next decade, delayed screening may lead to an additional 4,500 deaths from CRC.

“These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest,” Dr. Issaka wrote, as coauthor of a study published in Gastrointestinal Endoscopy.

Dr. Issaka and colleagues predict that the pandemic will likely worsen “persistent CRC disparities” in African-American and Hispanic communities, including relatively decreased screening participation, delayed follow-up of abnormal stool results, limited community-based research and partnerships, and limited community engagement and advocacy.

“COVID-19 related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations,” wrote Dr. Issaka and colleagues.

Dr. Issaka described similar issues in hepatology. She referred to a recent opinion article by Tapper and colleagues, which predicted that the COVID-19 pandemic will impact patients with liver disease in three waves: first, by delaying liver transplants, elective procedures, imaging, and routine patient follow-up; second, by increasing emergent decompensations, transplant wait-list dropouts, and care deferrals; and third, by losing patients to follow-up, resulting in missed diagnoses, incomplete cancer screening, and progressive disease.

“This could disproportionately impact Black, Hispanic, and Native-American populations, who may have already had difficulty accessing [liver care],” Dr. Issaka said.

To mitigate growing disparities, Dr. Issaka proposed a variety of strategies for CRC and liver disease.

For CRC screening, Dr. Issaka suggested noninvasive modalities, including mailed fecal immunochemical tests (FIT), with focused follow-up on patients with highest FIT values. For those conducting CRC research, Dr. Issaka recommended using accessible technology, engaging with community partners, providing incentives where appropriate, and other methods. For cirrhosis care, Dr. Issaka suggested that practitioners turn to telehealth and remote care, including weight monitoring, cognitive function testing, home medication delivery, and online education.

More broadly, Dr. Issaka called for universal health insurance not associated with employment, research funding for health disparities, sustainable employment wages, climate justice, desegregation of housing, and universal broadband Internet.

“The solutions to these problems are multipronged,” Dr. Issaka said. “Some will happen locally; for instance, well-executed planning around telehealth. Some will happen at the state level through opportunities like advocacy or even just reaching out to your own [congressional representative]. And then some will also happen programmatically – How can we as a health system begin to leverage something like mailed FIT?”

Finally, Dr. Issaka suggested that tools from another branch of science can help improve screening rates.

“We don’t, in medicine, tap into the benefits of behavioral psychology enough,” she said. “That’s a great discipline with really great tools that we can all use.”

Dr. Issaka described the power of community, in that people are more likely to undergo screening if they know how many others in their community are also being screened.

“I think as much as we can gather those kinds of data and share those with individuals to provide reassurance about the safety and importance of screening, I think [that] will help,” she said.

The AGA FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (DK118761). Dr. Issaka has no conflicts of interest.

SOURCES: Issaka. AGA FORWARD Program Webinar. 2020 Aug 27; Balzora et al. Gastrointestinal Endoscopy. 2020 June 20. doi: 10.1016/j.gie.2020.06.042; Tapper et al. Journal of Hepatology. 2020 Apr 13. doi: 10.1016/j.jhep.2020.04.005.

Suspension of disease screening and nonurgent procedures because of the COVID-19 pandemic will negatively impact long-term outcomes of GI and liver disease, and people of color will be disproportionately affected, according to a leading expert.

Novel, multipronged approaches are needed to overcome widening disparities in gastroenterology and hepatology, said Rachel Issaka, MD, of Fred Hutchinson Cancer Research Center in Seattle.

“The COVID-19 pandemic has led to unprecedented drops in breast, colorectal, and cervical cancer screenings,” Dr. Issaka said during an AGA FORWARD Program webinar. Screening rates for these diseases are down 83%-90%, she said.

“Certainly this creates a backlog of cancer screenings that need to occur, which poses very significant challenges for health systems as they’re adapting to this new state of health care that we have to provide,” Dr. Issaka said.

During her presentation, Dr. Issaka first addressed pandemic-related issues in colorectal cancer (CRC).

The sudden decrease in colonoscopies has already affected diagnoses, she said, as 32% fewer cases of CRC were diagnosed in April 2020 compared with April 2019, a finding that is “obviously very concerning.” All downstream effects remain to be seen; however, one estimate suggests that over the next decade, delayed screening may lead to an additional 4,500 deaths from CRC.

“These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest,” Dr. Issaka wrote, as coauthor of a study published in Gastrointestinal Endoscopy.

Dr. Issaka and colleagues predict that the pandemic will likely worsen “persistent CRC disparities” in African-American and Hispanic communities, including relatively decreased screening participation, delayed follow-up of abnormal stool results, limited community-based research and partnerships, and limited community engagement and advocacy.

“COVID-19 related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations,” wrote Dr. Issaka and colleagues.

Dr. Issaka described similar issues in hepatology. She referred to a recent opinion article by Tapper and colleagues, which predicted that the COVID-19 pandemic will impact patients with liver disease in three waves: first, by delaying liver transplants, elective procedures, imaging, and routine patient follow-up; second, by increasing emergent decompensations, transplant wait-list dropouts, and care deferrals; and third, by losing patients to follow-up, resulting in missed diagnoses, incomplete cancer screening, and progressive disease.

“This could disproportionately impact Black, Hispanic, and Native-American populations, who may have already had difficulty accessing [liver care],” Dr. Issaka said.

To mitigate growing disparities, Dr. Issaka proposed a variety of strategies for CRC and liver disease.

For CRC screening, Dr. Issaka suggested noninvasive modalities, including mailed fecal immunochemical tests (FIT), with focused follow-up on patients with highest FIT values. For those conducting CRC research, Dr. Issaka recommended using accessible technology, engaging with community partners, providing incentives where appropriate, and other methods. For cirrhosis care, Dr. Issaka suggested that practitioners turn to telehealth and remote care, including weight monitoring, cognitive function testing, home medication delivery, and online education.

More broadly, Dr. Issaka called for universal health insurance not associated with employment, research funding for health disparities, sustainable employment wages, climate justice, desegregation of housing, and universal broadband Internet.

“The solutions to these problems are multipronged,” Dr. Issaka said. “Some will happen locally; for instance, well-executed planning around telehealth. Some will happen at the state level through opportunities like advocacy or even just reaching out to your own [congressional representative]. And then some will also happen programmatically – How can we as a health system begin to leverage something like mailed FIT?”

Finally, Dr. Issaka suggested that tools from another branch of science can help improve screening rates.

“We don’t, in medicine, tap into the benefits of behavioral psychology enough,” she said. “That’s a great discipline with really great tools that we can all use.”

Dr. Issaka described the power of community, in that people are more likely to undergo screening if they know how many others in their community are also being screened.

“I think as much as we can gather those kinds of data and share those with individuals to provide reassurance about the safety and importance of screening, I think [that] will help,” she said.

The AGA FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (DK118761). Dr. Issaka has no conflicts of interest.

SOURCES: Issaka. AGA FORWARD Program Webinar. 2020 Aug 27; Balzora et al. Gastrointestinal Endoscopy. 2020 June 20. doi: 10.1016/j.gie.2020.06.042; Tapper et al. Journal of Hepatology. 2020 Apr 13. doi: 10.1016/j.jhep.2020.04.005.

The American Gastroenterological Association (AGA) has published a clinical practice update for endoscopic management of nonvariceal upper GI bleeding (NVUGIB).

The update includes 10 best practice recommendations based on clinical experience and a comprehensive literature review, reported lead author Daniel K. Mullady, MD, of Washington University in St. Louis.

“Numerous endoscopic devices have been developed over the past 30 years with demonstrated effectiveness in treating NVUGIB,” Dr. Mullady and colleagues wrote in Gastroenterology. “The purpose of this clinical practice update is to review the key concepts, new devices, and therapeutic strategies in endoscopically combating this age-old clinical dilemma.”

According to the investigators, endoscopy is central to management of NVUGIB, but only after patients are appropriately triaged and stabilized.

“[E]ndoscopy should be performed to determine the source of bleeding, to assess rebleeding risk, and to treat lesions at high risk for rebleeding,” they wrote. “Exactly when the endoscopy should be performed is a clinical judgment made by the gastroenterologist in consultation with the primary service.”

The investigators recommended that endoscopy be performed within 12 hours for emergent cases and within 24 hours for urgent cases, whereas elective cases could wait longer.

They noted that NVUGIB can range from mild and self-limiting, allowing for outpatient management, to severe and life-threatening, necessitating intensive care. Because of this broad range, the investigators recommended familiarity with triage scoring systems, including the Glasgow-Blatchford Score, the Rockall Score, and AIMS-65.

“A common decision is deciding whether or not to wait until the next morning to perform endoscopy on a patient presenting after hours with suspected NVUGIB,” the investigators wrote.

The investigators cautioned that emergent endoscopy may actually be associated with poorer outcomes because of “inadequate resuscitation,” and suggested that “[p]atients who are hemodynamically stable, do not have ongoing hematemesis, and have melena only can generally be deferred to the following morning.”

Concerning hemostatic technique, Dr. Mullady and colleagues recommended familiarity with conventional thermal therapy and placement of hemoclips. If these approaches are unsuccessful, or deemed unlikely to succeed, they recommended an over-the-scope clip.

For ulcers “with a rigid and fibrotic base,” or those that are hard to reach, the investigators recommended monopolar hemostatic forceps with low-voltage coagulation.

According to the update, hemostatic powder should be reserved for scenarios in which bleeding is diffuse and difficult to locate.

“In most instances, hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement,” the investigators wrote.

They noted that hemostatic powder generally dissolves in less than 24 hours, so additional treatment approaches should be considered, particular when there is a high risk of rebleeding.

When deciding between transcatheter arterial embolization (TAE) and surgery after endoscopic failure, the update calls for a comprehensive clinical assessment that incorporates patient factors, such as coagulopathy, hemodynamic instability, and multiorgan failure; bleeding etiology; potential adverse effects; and rebleeding risk.

“An important point is that prophylactic TAE of high-risk ulcers after successful endoscopic therapy is not recommended,” the investigators wrote.

Beyond these recommendations, the update includes a comprehensive discussion of relevant literature and strategies for effective clinical decision making. The discussion concludes with global remarks about the evolving role of endoscopy in managing NVUGIB, including a note about cost-effectiveness despite up-front expenses associated with some methods.

“With this expanded endoscopic armamentarium, endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB,” the investigators wrote. “Despite the increased costs of newer devices or multimodal therapy, effective hemostasis to preventing rebleeding and the need for hospital readmission is likely to be a dominant cost-saving strategy.”

Dr. Mullady disclosed relationships with Boston Scientific, ConMed, and Cook Medical.

This story was updated on 9/9/2020.

SOURCE: Mullady DK et al. Gastro. 2020 Jun 20. doi: 10.1053/j.gastro.2020.05.095.

The American Gastroenterological Association (AGA) has published a clinical practice update for endoscopic management of nonvariceal upper GI bleeding (NVUGIB).

The update includes 10 best practice recommendations based on clinical experience and a comprehensive literature review, reported lead author Daniel K. Mullady, MD, of Washington University in St. Louis.

“Numerous endoscopic devices have been developed over the past 30 years with demonstrated effectiveness in treating NVUGIB,” Dr. Mullady and colleagues wrote in Gastroenterology. “The purpose of this clinical practice update is to review the key concepts, new devices, and therapeutic strategies in endoscopically combating this age-old clinical dilemma.”

According to the investigators, endoscopy is central to management of NVUGIB, but only after patients are appropriately triaged and stabilized.

“[E]ndoscopy should be performed to determine the source of bleeding, to assess rebleeding risk, and to treat lesions at high risk for rebleeding,” they wrote. “Exactly when the endoscopy should be performed is a clinical judgment made by the gastroenterologist in consultation with the primary service.”

The investigators recommended that endoscopy be performed within 12 hours for emergent cases and within 24 hours for urgent cases, whereas elective cases could wait longer.

They noted that NVUGIB can range from mild and self-limiting, allowing for outpatient management, to severe and life-threatening, necessitating intensive care. Because of this broad range, the investigators recommended familiarity with triage scoring systems, including the Glasgow-Blatchford Score, the Rockall Score, and AIMS-65.

“A common decision is deciding whether or not to wait until the next morning to perform endoscopy on a patient presenting after hours with suspected NVUGIB,” the investigators wrote.

The investigators cautioned that emergent endoscopy may actually be associated with poorer outcomes because of “inadequate resuscitation,” and suggested that “[p]atients who are hemodynamically stable, do not have ongoing hematemesis, and have melena only can generally be deferred to the following morning.”

Concerning hemostatic technique, Dr. Mullady and colleagues recommended familiarity with conventional thermal therapy and placement of hemoclips. If these approaches are unsuccessful, or deemed unlikely to succeed, they recommended an over-the-scope clip.

For ulcers “with a rigid and fibrotic base,” or those that are hard to reach, the investigators recommended monopolar hemostatic forceps with low-voltage coagulation.

According to the update, hemostatic powder should be reserved for scenarios in which bleeding is diffuse and difficult to locate.

“In most instances, hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement,” the investigators wrote.

They noted that hemostatic powder generally dissolves in less than 24 hours, so additional treatment approaches should be considered, particular when there is a high risk of rebleeding.

When deciding between transcatheter arterial embolization (TAE) and surgery after endoscopic failure, the update calls for a comprehensive clinical assessment that incorporates patient factors, such as coagulopathy, hemodynamic instability, and multiorgan failure; bleeding etiology; potential adverse effects; and rebleeding risk.

“An important point is that prophylactic TAE of high-risk ulcers after successful endoscopic therapy is not recommended,” the investigators wrote.

Beyond these recommendations, the update includes a comprehensive discussion of relevant literature and strategies for effective clinical decision making. The discussion concludes with global remarks about the evolving role of endoscopy in managing NVUGIB, including a note about cost-effectiveness despite up-front expenses associated with some methods.

“With this expanded endoscopic armamentarium, endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB,” the investigators wrote. “Despite the increased costs of newer devices or multimodal therapy, effective hemostasis to preventing rebleeding and the need for hospital readmission is likely to be a dominant cost-saving strategy.”

Dr. Mullady disclosed relationships with Boston Scientific, ConMed, and Cook Medical.

This story was updated on 9/9/2020.

SOURCE: Mullady DK et al. Gastro. 2020 Jun 20. doi: 10.1053/j.gastro.2020.05.095.

The American Gastroenterological Association (AGA) has published a clinical practice update for endoscopic management of nonvariceal upper GI bleeding (NVUGIB).

The update includes 10 best practice recommendations based on clinical experience and a comprehensive literature review, reported lead author Daniel K. Mullady, MD, of Washington University in St. Louis.

“Numerous endoscopic devices have been developed over the past 30 years with demonstrated effectiveness in treating NVUGIB,” Dr. Mullady and colleagues wrote in Gastroenterology. “The purpose of this clinical practice update is to review the key concepts, new devices, and therapeutic strategies in endoscopically combating this age-old clinical dilemma.”

According to the investigators, endoscopy is central to management of NVUGIB, but only after patients are appropriately triaged and stabilized.

“[E]ndoscopy should be performed to determine the source of bleeding, to assess rebleeding risk, and to treat lesions at high risk for rebleeding,” they wrote. “Exactly when the endoscopy should be performed is a clinical judgment made by the gastroenterologist in consultation with the primary service.”

The investigators recommended that endoscopy be performed within 12 hours for emergent cases and within 24 hours for urgent cases, whereas elective cases could wait longer.

They noted that NVUGIB can range from mild and self-limiting, allowing for outpatient management, to severe and life-threatening, necessitating intensive care. Because of this broad range, the investigators recommended familiarity with triage scoring systems, including the Glasgow-Blatchford Score, the Rockall Score, and AIMS-65.

“A common decision is deciding whether or not to wait until the next morning to perform endoscopy on a patient presenting after hours with suspected NVUGIB,” the investigators wrote.

The investigators cautioned that emergent endoscopy may actually be associated with poorer outcomes because of “inadequate resuscitation,” and suggested that “[p]atients who are hemodynamically stable, do not have ongoing hematemesis, and have melena only can generally be deferred to the following morning.”

Concerning hemostatic technique, Dr. Mullady and colleagues recommended familiarity with conventional thermal therapy and placement of hemoclips. If these approaches are unsuccessful, or deemed unlikely to succeed, they recommended an over-the-scope clip.

For ulcers “with a rigid and fibrotic base,” or those that are hard to reach, the investigators recommended monopolar hemostatic forceps with low-voltage coagulation.

According to the update, hemostatic powder should be reserved for scenarios in which bleeding is diffuse and difficult to locate.

“In most instances, hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement,” the investigators wrote.

They noted that hemostatic powder generally dissolves in less than 24 hours, so additional treatment approaches should be considered, particular when there is a high risk of rebleeding.

When deciding between transcatheter arterial embolization (TAE) and surgery after endoscopic failure, the update calls for a comprehensive clinical assessment that incorporates patient factors, such as coagulopathy, hemodynamic instability, and multiorgan failure; bleeding etiology; potential adverse effects; and rebleeding risk.

“An important point is that prophylactic TAE of high-risk ulcers after successful endoscopic therapy is not recommended,” the investigators wrote.

Beyond these recommendations, the update includes a comprehensive discussion of relevant literature and strategies for effective clinical decision making. The discussion concludes with global remarks about the evolving role of endoscopy in managing NVUGIB, including a note about cost-effectiveness despite up-front expenses associated with some methods.

“With this expanded endoscopic armamentarium, endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB,” the investigators wrote. “Despite the increased costs of newer devices or multimodal therapy, effective hemostasis to preventing rebleeding and the need for hospital readmission is likely to be a dominant cost-saving strategy.”

Dr. Mullady disclosed relationships with Boston Scientific, ConMed, and Cook Medical.

This story was updated on 9/9/2020.

SOURCE: Mullady DK et al. Gastro. 2020 Jun 20. doi: 10.1053/j.gastro.2020.05.095.

The American Gastroenterological Association (AGA) has released a clinical practice guideline for gastrointestinal evaluation of iron-deficiency anemia.

The seven recommendations aim to improve quality of care and reduce practice variability, according to lead author Cynthia W. Ko, MD, of the University of Washington , Seattle, and four copanelists.

First, the panel recommended that iron deficiency be defined by a serum ferritin level less than 45 ng/mL, instead of 15 ng/mL. Data from 55 studies showed that the higher cutoff value had a sensitivity of 85% and a specificity of 92%, compared with respective values of 59% and 99% for the lower threshold.

“Optimizing the threshold ferritin level with high sensitivity will detect the great majority of patients who are truly iron deficient, minimize delays in diagnostic workup, and minimize the number of patients in whom serious underlying etiologies such as gastrointestinal malignancy might be missed,” the panelists wrote. The guideline was published in Gastroenterology.

For asymptomatic postmenopausal women and men with iron-deficiency anemia, the panel recommended bidirectional endoscopy instead of no endoscopy. A similar recommendation was given for premenopausal women, calling for bidirectional endoscopy instead of iron-replacement therapy alone.

Dr. Ko and colleagues noted that these recommendations differ from those issued by the British Society of Gastroenterology (BSG).

For postmenopausal women and men, the BSG suggests that symptoms and local availability of endoscopy should inform diagnostic workup, with either colonoscopy or CT colonography used for assessment. The BSG recommends against bidirectional endoscopy in premenopausal women, unless they are older than 50 years, have a family history of colorectal cancer, or show symptoms of gastrointestinal disease.

“In contrast, the AGA recommends bidirectional endoscopy as the mainstay for gastrointestinal evaluation, particularly in men and in postmenopausal women where no other unequivocal source of iron deficiency has been identified,” the panelists wrote.

When bidirectional endoscopy does not reveal an etiology, the panelists recommended noninvasive testing for Helicobacter pylori.

“An association between H. pylori infection and iron deficiency has been demonstrated in observational studies,” noted Dr. Ko and colleagues.

They also cited three randomized controlled trials in which treating patients with iron-deficiency anemia for H. pylori infection in combination with iron replacement therapy led to a 23.2-ng/mL mean improvement in serum ferritin, compared with patients who received iron-replacement therapy alone.

According to the guideline, if asymptomatic patients with negative bidirectional endoscopy are also negative for H. pylori, then they should receive trial iron supplementation, instead of undergoing video capsule endoscopy.

“[T]he evidence required to evaluate the benefits of video capsule endoscopy in iron-deficiency anemia is not currently available,” the panelists noted.

Dr. Ko and colleagues also recommended against routine gastric biopsies to diagnose autoimmune atrophic gastritis, as earlier diagnosis does not appear to affect outcomes or management of iron-deficiency anemia.

Finally, the panelists recommended that asymptomatic patients with iron-deficiency anemia and suspected celiac disease undergo serologic testing first, with small bowel biopsy only performed if testing is positive.

The only two strong recommendations in the guideline are for the ferritin cutoff value and the use of bidirectional endoscopy in men and postmenopausal women. The other five recommendations are conditional, three of which are based on very low quality evidence. As such, the guideline includes a discussion of research needs.

Dr. Ko and colleagues called for more studies investigating the prevalence of gastrointestinal lesions and risks of bidirectional endoscopy in premenopausal women, role of fecal occult blood testing, timing of serologic testing for H. pylori and celiac disease in relation to endoscopy, patient subgroups, comparative efficacy of small bowel visualization techniques, and other topics.

The investigators disclosed no conflicts of interest. The guideline was funded by the AGA Institute.

SOURCE: Ko CW et al. Gastroenterology 2020 Aug 15. doi: 10.1053/j.gastro.2020.06.046.

The American Gastroenterological Association (AGA) has released a clinical practice guideline for gastrointestinal evaluation of iron-deficiency anemia.

The seven recommendations aim to improve quality of care and reduce practice variability, according to lead author Cynthia W. Ko, MD, of the University of Washington , Seattle, and four copanelists.

First, the panel recommended that iron deficiency be defined by a serum ferritin level less than 45 ng/mL, instead of 15 ng/mL. Data from 55 studies showed that the higher cutoff value had a sensitivity of 85% and a specificity of 92%, compared with respective values of 59% and 99% for the lower threshold.

“Optimizing the threshold ferritin level with high sensitivity will detect the great majority of patients who are truly iron deficient, minimize delays in diagnostic workup, and minimize the number of patients in whom serious underlying etiologies such as gastrointestinal malignancy might be missed,” the panelists wrote. The guideline was published in Gastroenterology.

For asymptomatic postmenopausal women and men with iron-deficiency anemia, the panel recommended bidirectional endoscopy instead of no endoscopy. A similar recommendation was given for premenopausal women, calling for bidirectional endoscopy instead of iron-replacement therapy alone.

Dr. Ko and colleagues noted that these recommendations differ from those issued by the British Society of Gastroenterology (BSG).

For postmenopausal women and men, the BSG suggests that symptoms and local availability of endoscopy should inform diagnostic workup, with either colonoscopy or CT colonography used for assessment. The BSG recommends against bidirectional endoscopy in premenopausal women, unless they are older than 50 years, have a family history of colorectal cancer, or show symptoms of gastrointestinal disease.

“In contrast, the AGA recommends bidirectional endoscopy as the mainstay for gastrointestinal evaluation, particularly in men and in postmenopausal women where no other unequivocal source of iron deficiency has been identified,” the panelists wrote.

When bidirectional endoscopy does not reveal an etiology, the panelists recommended noninvasive testing for Helicobacter pylori.

“An association between H. pylori infection and iron deficiency has been demonstrated in observational studies,” noted Dr. Ko and colleagues.

They also cited three randomized controlled trials in which treating patients with iron-deficiency anemia for H. pylori infection in combination with iron replacement therapy led to a 23.2-ng/mL mean improvement in serum ferritin, compared with patients who received iron-replacement therapy alone.

According to the guideline, if asymptomatic patients with negative bidirectional endoscopy are also negative for H. pylori, then they should receive trial iron supplementation, instead of undergoing video capsule endoscopy.

“[T]he evidence required to evaluate the benefits of video capsule endoscopy in iron-deficiency anemia is not currently available,” the panelists noted.

Dr. Ko and colleagues also recommended against routine gastric biopsies to diagnose autoimmune atrophic gastritis, as earlier diagnosis does not appear to affect outcomes or management of iron-deficiency anemia.

Finally, the panelists recommended that asymptomatic patients with iron-deficiency anemia and suspected celiac disease undergo serologic testing first, with small bowel biopsy only performed if testing is positive.

The only two strong recommendations in the guideline are for the ferritin cutoff value and the use of bidirectional endoscopy in men and postmenopausal women. The other five recommendations are conditional, three of which are based on very low quality evidence. As such, the guideline includes a discussion of research needs.

Dr. Ko and colleagues called for more studies investigating the prevalence of gastrointestinal lesions and risks of bidirectional endoscopy in premenopausal women, role of fecal occult blood testing, timing of serologic testing for H. pylori and celiac disease in relation to endoscopy, patient subgroups, comparative efficacy of small bowel visualization techniques, and other topics.

The investigators disclosed no conflicts of interest. The guideline was funded by the AGA Institute.

SOURCE: Ko CW et al. Gastroenterology 2020 Aug 15. doi: 10.1053/j.gastro.2020.06.046.

The American Gastroenterological Association (AGA) has released a clinical practice guideline for gastrointestinal evaluation of iron-deficiency anemia.

The seven recommendations aim to improve quality of care and reduce practice variability, according to lead author Cynthia W. Ko, MD, of the University of Washington , Seattle, and four copanelists.

First, the panel recommended that iron deficiency be defined by a serum ferritin level less than 45 ng/mL, instead of 15 ng/mL. Data from 55 studies showed that the higher cutoff value had a sensitivity of 85% and a specificity of 92%, compared with respective values of 59% and 99% for the lower threshold.

“Optimizing the threshold ferritin level with high sensitivity will detect the great majority of patients who are truly iron deficient, minimize delays in diagnostic workup, and minimize the number of patients in whom serious underlying etiologies such as gastrointestinal malignancy might be missed,” the panelists wrote. The guideline was published in Gastroenterology.

For asymptomatic postmenopausal women and men with iron-deficiency anemia, the panel recommended bidirectional endoscopy instead of no endoscopy. A similar recommendation was given for premenopausal women, calling for bidirectional endoscopy instead of iron-replacement therapy alone.

Dr. Ko and colleagues noted that these recommendations differ from those issued by the British Society of Gastroenterology (BSG).

For postmenopausal women and men, the BSG suggests that symptoms and local availability of endoscopy should inform diagnostic workup, with either colonoscopy or CT colonography used for assessment. The BSG recommends against bidirectional endoscopy in premenopausal women, unless they are older than 50 years, have a family history of colorectal cancer, or show symptoms of gastrointestinal disease.

“In contrast, the AGA recommends bidirectional endoscopy as the mainstay for gastrointestinal evaluation, particularly in men and in postmenopausal women where no other unequivocal source of iron deficiency has been identified,” the panelists wrote.

When bidirectional endoscopy does not reveal an etiology, the panelists recommended noninvasive testing for Helicobacter pylori.

“An association between H. pylori infection and iron deficiency has been demonstrated in observational studies,” noted Dr. Ko and colleagues.

They also cited three randomized controlled trials in which treating patients with iron-deficiency anemia for H. pylori infection in combination with iron replacement therapy led to a 23.2-ng/mL mean improvement in serum ferritin, compared with patients who received iron-replacement therapy alone.

According to the guideline, if asymptomatic patients with negative bidirectional endoscopy are also negative for H. pylori, then they should receive trial iron supplementation, instead of undergoing video capsule endoscopy.

“[T]he evidence required to evaluate the benefits of video capsule endoscopy in iron-deficiency anemia is not currently available,” the panelists noted.

Dr. Ko and colleagues also recommended against routine gastric biopsies to diagnose autoimmune atrophic gastritis, as earlier diagnosis does not appear to affect outcomes or management of iron-deficiency anemia.

Finally, the panelists recommended that asymptomatic patients with iron-deficiency anemia and suspected celiac disease undergo serologic testing first, with small bowel biopsy only performed if testing is positive.

The only two strong recommendations in the guideline are for the ferritin cutoff value and the use of bidirectional endoscopy in men and postmenopausal women. The other five recommendations are conditional, three of which are based on very low quality evidence. As such, the guideline includes a discussion of research needs.

Dr. Ko and colleagues called for more studies investigating the prevalence of gastrointestinal lesions and risks of bidirectional endoscopy in premenopausal women, role of fecal occult blood testing, timing of serologic testing for H. pylori and celiac disease in relation to endoscopy, patient subgroups, comparative efficacy of small bowel visualization techniques, and other topics.

The investigators disclosed no conflicts of interest. The guideline was funded by the AGA Institute.

SOURCE: Ko CW et al. Gastroenterology 2020 Aug 15. doi: 10.1053/j.gastro.2020.06.046.

Clinicians frequently increase doses of anti–tumor necrosis factor (anti-TNF) agents for patients with inflammatory bowel disease (IBD) without objective evidence of active inflammation, based on a retrospective study.

This strategy may be ineffective and expensive, according to lead author Evan D. Elias, MD, of the University of Manitoba, Winnipeg, Canada, and colleagues, who noted that worsening symptoms may have noninflammatory causes, such as coexisting functional disorders.

“Objective evidence of active inflammation is a key part of [the dose escalation] process,” the investigators wrote in the Journal of Clinical Gastroenterology, “however, there are no data assessing whether an adequate evaluation of the cause of persistent gastrointestinal symptoms is routinely undertaken in clinical practice.”

To address this knowledge gap, Dr. Elias and colleagues conducted a retrospective study involving 23 physicians in Manitoba who initiated anti-TNF therapy in 838 patients with IBD during 2005-2016. The primary outcome was rate of dose escalation within 1 year. Secondarily, the investigators audited 11 out of 23 prescribers to determine how frequently patients receiving increased doses underwent objective assessment of inflammation, both in general and in the 90 days preceding dose escalation.

Of note, therapeutic drug monitoring, fecal calprotectin testing, and transabdominal ultrasound were not commonly available to prescribers during the study period.

Within 1 year, almost one-third of patients (32.9%) received increased doses of either adalimumab or infliximab, with no significant difference in escalation practices between the two agents. After approximately 2 years, increased doses were prescribed for almost half of the patients (49%), with a median time to dose increase of 17.4 months.

Patients with ulcerative colitis were 83% more likely to receive increased doses than were those with Crohn’s disease (P = .0001), and doses were typically escalated at an earlier date (7.1 vs. 11.1 months). In contrast, dose escalation was not associated with a variety of other patient factors, such as sex, age, or baseline laboratory values.

Comprehensive data from 11 prescribers showed that 70.8% of patients who received increased doses underwent some form of testing to assess inflammation, but only 24.7% of them had objective evidence of inflammatory activity that supported the dose increase.

Raymond K. Cross Jr., MD, MS, AGAF, FACG, director of the IBD program at the University of Maryland, Baltimore County, said that the findings were “not surprising.”

Dr. Cross said that patients with IBD should ideally undergo testing for drug levels and inflammatory activity prior to dose escalation, but this one-size-fits-all approach doesn’t always translate to real-world practice.

“There’s the science, and there’s the practical,” he said, noting that dose escalation may precede testing “in an effort to be efficient and decrease suffering.” This includes cases in which patients receive an earlier or increased dose to bridge the gap between worsening of symptoms and completion of diagnostics.

Dr. Cross also pointed out that patients with ulcerative colitis typically have a strong correlation between symptoms and level of inflammation.

“If [a patient with ulcerative colitis] has bloody diarrhea, it’s 90% or so that they’re going to have active inflammation in their colon, so I feel less obligated to do those checks in an ulcerative colitis patient who has classic symptoms,” he said.

Byron Vaughn, MD, codirector of the IBD program at the University of Minnesota, Minneapolis, suggested that the study by Elias and colleagues “serves as an important reminder to follow the tenets of a treat-to-target strategy, which include regular assessment of objective markers of inflammation specific to IBD before and after a dose adjustment.”

Still, like Dr. Cross, Dr. Vaughn noted that dose escalation without additional testing “may be reasonable” in certain scenarios, such as when patients with ulcerative colitis have bloody diarrhea and tenesmus or for patients with perianal Crohn’s disease.

“A key limitation of this study is the lack of drug concentration monitoring,” Dr. Vaughn said. “Due to the immunogenicity of anti-TNF medications there is a strong rationale for proactive dose adjustments to avoid low or undetectable concentrations and subsequent antibody formation. However, as the authors point out, this is unlikely to be a major factor in this particular study as drug concentration measurement was not routinely available over the study period.”

The investigators disclosed relationships with AbbVie, Ferring, Janssen, and others. Dr. Vaughn disclosed relationships with AbbVie, Celgene, Genentech, Takeda, and others. Dr. Cross disclosed relationships with AbbVie, Janssen, and Samsung Bioepis.

SOURCE: Elias ED et al. J Clin Gastroenterol. 2020 Jul 17. doi: 10.1097/MCG.0000000000001391.

Clinicians frequently increase doses of anti–tumor necrosis factor (anti-TNF) agents for patients with inflammatory bowel disease (IBD) without objective evidence of active inflammation, based on a retrospective study.

This strategy may be ineffective and expensive, according to lead author Evan D. Elias, MD, of the University of Manitoba, Winnipeg, Canada, and colleagues, who noted that worsening symptoms may have noninflammatory causes, such as coexisting functional disorders.

“Objective evidence of active inflammation is a key part of [the dose escalation] process,” the investigators wrote in the Journal of Clinical Gastroenterology, “however, there are no data assessing whether an adequate evaluation of the cause of persistent gastrointestinal symptoms is routinely undertaken in clinical practice.”

To address this knowledge gap, Dr. Elias and colleagues conducted a retrospective study involving 23 physicians in Manitoba who initiated anti-TNF therapy in 838 patients with IBD during 2005-2016. The primary outcome was rate of dose escalation within 1 year. Secondarily, the investigators audited 11 out of 23 prescribers to determine how frequently patients receiving increased doses underwent objective assessment of inflammation, both in general and in the 90 days preceding dose escalation.

Of note, therapeutic drug monitoring, fecal calprotectin testing, and transabdominal ultrasound were not commonly available to prescribers during the study period.

Within 1 year, almost one-third of patients (32.9%) received increased doses of either adalimumab or infliximab, with no significant difference in escalation practices between the two agents. After approximately 2 years, increased doses were prescribed for almost half of the patients (49%), with a median time to dose increase of 17.4 months.

Patients with ulcerative colitis were 83% more likely to receive increased doses than were those with Crohn’s disease (P = .0001), and doses were typically escalated at an earlier date (7.1 vs. 11.1 months). In contrast, dose escalation was not associated with a variety of other patient factors, such as sex, age, or baseline laboratory values.

Comprehensive data from 11 prescribers showed that 70.8% of patients who received increased doses underwent some form of testing to assess inflammation, but only 24.7% of them had objective evidence of inflammatory activity that supported the dose increase.

Raymond K. Cross Jr., MD, MS, AGAF, FACG, director of the IBD program at the University of Maryland, Baltimore County, said that the findings were “not surprising.”

Dr. Cross said that patients with IBD should ideally undergo testing for drug levels and inflammatory activity prior to dose escalation, but this one-size-fits-all approach doesn’t always translate to real-world practice.

“There’s the science, and there’s the practical,” he said, noting that dose escalation may precede testing “in an effort to be efficient and decrease suffering.” This includes cases in which patients receive an earlier or increased dose to bridge the gap between worsening of symptoms and completion of diagnostics.

Dr. Cross also pointed out that patients with ulcerative colitis typically have a strong correlation between symptoms and level of inflammation.

“If [a patient with ulcerative colitis] has bloody diarrhea, it’s 90% or so that they’re going to have active inflammation in their colon, so I feel less obligated to do those checks in an ulcerative colitis patient who has classic symptoms,” he said.

Byron Vaughn, MD, codirector of the IBD program at the University of Minnesota, Minneapolis, suggested that the study by Elias and colleagues “serves as an important reminder to follow the tenets of a treat-to-target strategy, which include regular assessment of objective markers of inflammation specific to IBD before and after a dose adjustment.”

Still, like Dr. Cross, Dr. Vaughn noted that dose escalation without additional testing “may be reasonable” in certain scenarios, such as when patients with ulcerative colitis have bloody diarrhea and tenesmus or for patients with perianal Crohn’s disease.

“A key limitation of this study is the lack of drug concentration monitoring,” Dr. Vaughn said. “Due to the immunogenicity of anti-TNF medications there is a strong rationale for proactive dose adjustments to avoid low or undetectable concentrations and subsequent antibody formation. However, as the authors point out, this is unlikely to be a major factor in this particular study as drug concentration measurement was not routinely available over the study period.”

The investigators disclosed relationships with AbbVie, Ferring, Janssen, and others. Dr. Vaughn disclosed relationships with AbbVie, Celgene, Genentech, Takeda, and others. Dr. Cross disclosed relationships with AbbVie, Janssen, and Samsung Bioepis.

SOURCE: Elias ED et al. J Clin Gastroenterol. 2020 Jul 17. doi: 10.1097/MCG.0000000000001391.

Clinicians frequently increase doses of anti–tumor necrosis factor (anti-TNF) agents for patients with inflammatory bowel disease (IBD) without objective evidence of active inflammation, based on a retrospective study.

This strategy may be ineffective and expensive, according to lead author Evan D. Elias, MD, of the University of Manitoba, Winnipeg, Canada, and colleagues, who noted that worsening symptoms may have noninflammatory causes, such as coexisting functional disorders.

“Objective evidence of active inflammation is a key part of [the dose escalation] process,” the investigators wrote in the Journal of Clinical Gastroenterology, “however, there are no data assessing whether an adequate evaluation of the cause of persistent gastrointestinal symptoms is routinely undertaken in clinical practice.”

To address this knowledge gap, Dr. Elias and colleagues conducted a retrospective study involving 23 physicians in Manitoba who initiated anti-TNF therapy in 838 patients with IBD during 2005-2016. The primary outcome was rate of dose escalation within 1 year. Secondarily, the investigators audited 11 out of 23 prescribers to determine how frequently patients receiving increased doses underwent objective assessment of inflammation, both in general and in the 90 days preceding dose escalation.

Of note, therapeutic drug monitoring, fecal calprotectin testing, and transabdominal ultrasound were not commonly available to prescribers during the study period.

Within 1 year, almost one-third of patients (32.9%) received increased doses of either adalimumab or infliximab, with no significant difference in escalation practices between the two agents. After approximately 2 years, increased doses were prescribed for almost half of the patients (49%), with a median time to dose increase of 17.4 months.

Patients with ulcerative colitis were 83% more likely to receive increased doses than were those with Crohn’s disease (P = .0001), and doses were typically escalated at an earlier date (7.1 vs. 11.1 months). In contrast, dose escalation was not associated with a variety of other patient factors, such as sex, age, or baseline laboratory values.

Comprehensive data from 11 prescribers showed that 70.8% of patients who received increased doses underwent some form of testing to assess inflammation, but only 24.7% of them had objective evidence of inflammatory activity that supported the dose increase.

Raymond K. Cross Jr., MD, MS, AGAF, FACG, director of the IBD program at the University of Maryland, Baltimore County, said that the findings were “not surprising.”

Dr. Cross said that patients with IBD should ideally undergo testing for drug levels and inflammatory activity prior to dose escalation, but this one-size-fits-all approach doesn’t always translate to real-world practice.

“There’s the science, and there’s the practical,” he said, noting that dose escalation may precede testing “in an effort to be efficient and decrease suffering.” This includes cases in which patients receive an earlier or increased dose to bridge the gap between worsening of symptoms and completion of diagnostics.

Dr. Cross also pointed out that patients with ulcerative colitis typically have a strong correlation between symptoms and level of inflammation.

“If [a patient with ulcerative colitis] has bloody diarrhea, it’s 90% or so that they’re going to have active inflammation in their colon, so I feel less obligated to do those checks in an ulcerative colitis patient who has classic symptoms,” he said.

Byron Vaughn, MD, codirector of the IBD program at the University of Minnesota, Minneapolis, suggested that the study by Elias and colleagues “serves as an important reminder to follow the tenets of a treat-to-target strategy, which include regular assessment of objective markers of inflammation specific to IBD before and after a dose adjustment.”

Still, like Dr. Cross, Dr. Vaughn noted that dose escalation without additional testing “may be reasonable” in certain scenarios, such as when patients with ulcerative colitis have bloody diarrhea and tenesmus or for patients with perianal Crohn’s disease.

“A key limitation of this study is the lack of drug concentration monitoring,” Dr. Vaughn said. “Due to the immunogenicity of anti-TNF medications there is a strong rationale for proactive dose adjustments to avoid low or undetectable concentrations and subsequent antibody formation. However, as the authors point out, this is unlikely to be a major factor in this particular study as drug concentration measurement was not routinely available over the study period.”

The investigators disclosed relationships with AbbVie, Ferring, Janssen, and others. Dr. Vaughn disclosed relationships with AbbVie, Celgene, Genentech, Takeda, and others. Dr. Cross disclosed relationships with AbbVie, Janssen, and Samsung Bioepis.

SOURCE: Elias ED et al. J Clin Gastroenterol. 2020 Jul 17. doi: 10.1097/MCG.0000000000001391.

Mailing fecal immunochemical testing (FIT) kits with colorectal cancer (CRC) screening reminders appears cost effective and may boost screening rates across a variety of payers and providers, according to investigators.

Cost savings, when compared with mailing reminders alone, would be greatest from a Medicaid and state government perspective, reported lead author Stephanie B. Wheeler, PhD, MPH, of the University of North Carolina at Chapel Hill and colleagues.

“As payers and providers endeavor to increase the proportion of age-eligible adults who are up to date with CRC screening, according to the National Colorectal Cancer Roundtable target of 80% screened, understanding the comparative value of mailed FIT-based programs in low-income populations is urgently needed,” the investigators wrote in Cancer.

To address this need, Dr. Wheeler and colleagues coupled a randomized clinical trial with a cost-effectiveness analysis.

The trial involved 2,144 North Carolina Medicaid enrollees between 52 and 64 years of age who were overdue for CRC screening. Participants were randomly assigned to receive either a mailed reminder with an FIT kit or a mailed reminder alone. Those who received the reminder alone were provided with information about how to get an FIT kit or undergo screening colonoscopy.

The screening rate was significantly higher in the combination mailer group than it was the reminder-only group, at 21.1% versus 12.3% (P less than .01). Based on data from previous research, the investigators estimated that a number of participants also underwent colonoscopy screenings because of the reminders; this resulted in an estimated 23.3% screening rate among those who received an FIT kit, compared with 15.8% among those who received a reminder alone.

For cost analysis, these rates were entered into a model involving 35,000 Medicaid enrollees. Annual costs were compared from two perspectives: Medicaid/state and health clinic/facility, the latter of which included primary care providers, integrated health care systems, county health departments, and federally qualified health centers. The model incorporated a number of costs, such as those associated with equipment, mailing supplies, FIT kits, colonoscopy screenings, and personnel.

From a Medicaid/state perspective, the estimated total population screening cost of mailing both an FIT kit and reminder was $1.40 million, compared with $1.45 million for a reminder alone. This translated to a total cost per person screened of $172 for the combination mailer versus $262 for the reminder alone.

“Notably, compared with the reminder-only alternative, the reminder + FIT alternative was cost-saving or dominant from this perspective because it yielded more screenings at lower cost,” the investigators wrote.

The cost analysis from a health clinic/facility perspective was more nuanced.

While the estimated total population screening cost of a combination mailer was more than the reminder alone ($927,000 vs. $624,000), sending test kits led to screening of 2,598 additional individuals (8,131 vs. 5,533). The incremental cost-effectiveness ratio (ICER) for the combination mailer was $116 per person screened.

“This ICER fell within the range of what decision makers typically would be willing to pay for an additional person screened for CRC, previously shown to include ICERs as high as several hundred dollars or more,” the investigators noted.

According to Beverly B. Green, MD, MPH, of Kaiser Permanente Washington, Seattle, and Richard T. Meenan, PhD, MPH, of Kaiser Permanente Northwest, Portland, Oregon, who wrote a simultaneously published editorial, the study “suggests that direct FIT mailing can be highly cost effective if not cost saving within the Medicaid population, similar to tobacco-cessation programs or diabetes prevention programs in the same context of a Medicaid population.”

Still, practical details need to be resolved prior to real-world application, they added.

“[T]he analysis by Wheeler et al. raises an important question: Who should pay for mailed FIT screening programs?”

The answer, they suggested, may be health plans, since prevention of CRC could mitigate greater costs of care down the line. Further motivation could come from a program such as the Medicare 5-star program, which rewards higher screening rates with bonuses such as longer enrollment periods and higher payments, according to Dr. Green and Dr. Meenan.

“Unsurprisingly, Medicare CRC screening rates have been steadily increasing and now are approaching 80%,” they noted, “whereas Medicaid CRC screening rates remain low.”

The study was supported by the University of North Carolina, the Cancer Prevention and Control Research Network, the Centers for Disease Control and Prevention, and the National Cancer Institute. Dr. Wheeler reported grant funding from Pfizer.

SOURCE: Wheeler SB et al. Cancer. 2020 Jul 20. doi: 10.1002/cncr.32992.

Mailing fecal immunochemical testing (FIT) kits with colorectal cancer (CRC) screening reminders appears cost effective and may boost screening rates across a variety of payers and providers, according to investigators.

Cost savings, when compared with mailing reminders alone, would be greatest from a Medicaid and state government perspective, reported lead author Stephanie B. Wheeler, PhD, MPH, of the University of North Carolina at Chapel Hill and colleagues.

“As payers and providers endeavor to increase the proportion of age-eligible adults who are up to date with CRC screening, according to the National Colorectal Cancer Roundtable target of 80% screened, understanding the comparative value of mailed FIT-based programs in low-income populations is urgently needed,” the investigators wrote in Cancer.

To address this need, Dr. Wheeler and colleagues coupled a randomized clinical trial with a cost-effectiveness analysis.

The trial involved 2,144 North Carolina Medicaid enrollees between 52 and 64 years of age who were overdue for CRC screening. Participants were randomly assigned to receive either a mailed reminder with an FIT kit or a mailed reminder alone. Those who received the reminder alone were provided with information about how to get an FIT kit or undergo screening colonoscopy.

The screening rate was significantly higher in the combination mailer group than it was the reminder-only group, at 21.1% versus 12.3% (P less than .01). Based on data from previous research, the investigators estimated that a number of participants also underwent colonoscopy screenings because of the reminders; this resulted in an estimated 23.3% screening rate among those who received an FIT kit, compared with 15.8% among those who received a reminder alone.

For cost analysis, these rates were entered into a model involving 35,000 Medicaid enrollees. Annual costs were compared from two perspectives: Medicaid/state and health clinic/facility, the latter of which included primary care providers, integrated health care systems, county health departments, and federally qualified health centers. The model incorporated a number of costs, such as those associated with equipment, mailing supplies, FIT kits, colonoscopy screenings, and personnel.

From a Medicaid/state perspective, the estimated total population screening cost of mailing both an FIT kit and reminder was $1.40 million, compared with $1.45 million for a reminder alone. This translated to a total cost per person screened of $172 for the combination mailer versus $262 for the reminder alone.

“Notably, compared with the reminder-only alternative, the reminder + FIT alternative was cost-saving or dominant from this perspective because it yielded more screenings at lower cost,” the investigators wrote.

The cost analysis from a health clinic/facility perspective was more nuanced.

While the estimated total population screening cost of a combination mailer was more than the reminder alone ($927,000 vs. $624,000), sending test kits led to screening of 2,598 additional individuals (8,131 vs. 5,533). The incremental cost-effectiveness ratio (ICER) for the combination mailer was $116 per person screened.

“This ICER fell within the range of what decision makers typically would be willing to pay for an additional person screened for CRC, previously shown to include ICERs as high as several hundred dollars or more,” the investigators noted.

According to Beverly B. Green, MD, MPH, of Kaiser Permanente Washington, Seattle, and Richard T. Meenan, PhD, MPH, of Kaiser Permanente Northwest, Portland, Oregon, who wrote a simultaneously published editorial, the study “suggests that direct FIT mailing can be highly cost effective if not cost saving within the Medicaid population, similar to tobacco-cessation programs or diabetes prevention programs in the same context of a Medicaid population.”

Still, practical details need to be resolved prior to real-world application, they added.

“[T]he analysis by Wheeler et al. raises an important question: Who should pay for mailed FIT screening programs?”

The answer, they suggested, may be health plans, since prevention of CRC could mitigate greater costs of care down the line. Further motivation could come from a program such as the Medicare 5-star program, which rewards higher screening rates with bonuses such as longer enrollment periods and higher payments, according to Dr. Green and Dr. Meenan.

“Unsurprisingly, Medicare CRC screening rates have been steadily increasing and now are approaching 80%,” they noted, “whereas Medicaid CRC screening rates remain low.”

The study was supported by the University of North Carolina, the Cancer Prevention and Control Research Network, the Centers for Disease Control and Prevention, and the National Cancer Institute. Dr. Wheeler reported grant funding from Pfizer.

SOURCE: Wheeler SB et al. Cancer. 2020 Jul 20. doi: 10.1002/cncr.32992.

Mailing fecal immunochemical testing (FIT) kits with colorectal cancer (CRC) screening reminders appears cost effective and may boost screening rates across a variety of payers and providers, according to investigators.

Cost savings, when compared with mailing reminders alone, would be greatest from a Medicaid and state government perspective, reported lead author Stephanie B. Wheeler, PhD, MPH, of the University of North Carolina at Chapel Hill and colleagues.

“As payers and providers endeavor to increase the proportion of age-eligible adults who are up to date with CRC screening, according to the National Colorectal Cancer Roundtable target of 80% screened, understanding the comparative value of mailed FIT-based programs in low-income populations is urgently needed,” the investigators wrote in Cancer.

To address this need, Dr. Wheeler and colleagues coupled a randomized clinical trial with a cost-effectiveness analysis.

The trial involved 2,144 North Carolina Medicaid enrollees between 52 and 64 years of age who were overdue for CRC screening. Participants were randomly assigned to receive either a mailed reminder with an FIT kit or a mailed reminder alone. Those who received the reminder alone were provided with information about how to get an FIT kit or undergo screening colonoscopy.

The screening rate was significantly higher in the combination mailer group than it was the reminder-only group, at 21.1% versus 12.3% (P less than .01). Based on data from previous research, the investigators estimated that a number of participants also underwent colonoscopy screenings because of the reminders; this resulted in an estimated 23.3% screening rate among those who received an FIT kit, compared with 15.8% among those who received a reminder alone.

For cost analysis, these rates were entered into a model involving 35,000 Medicaid enrollees. Annual costs were compared from two perspectives: Medicaid/state and health clinic/facility, the latter of which included primary care providers, integrated health care systems, county health departments, and federally qualified health centers. The model incorporated a number of costs, such as those associated with equipment, mailing supplies, FIT kits, colonoscopy screenings, and personnel.

From a Medicaid/state perspective, the estimated total population screening cost of mailing both an FIT kit and reminder was $1.40 million, compared with $1.45 million for a reminder alone. This translated to a total cost per person screened of $172 for the combination mailer versus $262 for the reminder alone.

“Notably, compared with the reminder-only alternative, the reminder + FIT alternative was cost-saving or dominant from this perspective because it yielded more screenings at lower cost,” the investigators wrote.

The cost analysis from a health clinic/facility perspective was more nuanced.

While the estimated total population screening cost of a combination mailer was more than the reminder alone ($927,000 vs. $624,000), sending test kits led to screening of 2,598 additional individuals (8,131 vs. 5,533). The incremental cost-effectiveness ratio (ICER) for the combination mailer was $116 per person screened.

“This ICER fell within the range of what decision makers typically would be willing to pay for an additional person screened for CRC, previously shown to include ICERs as high as several hundred dollars or more,” the investigators noted.

According to Beverly B. Green, MD, MPH, of Kaiser Permanente Washington, Seattle, and Richard T. Meenan, PhD, MPH, of Kaiser Permanente Northwest, Portland, Oregon, who wrote a simultaneously published editorial, the study “suggests that direct FIT mailing can be highly cost effective if not cost saving within the Medicaid population, similar to tobacco-cessation programs or diabetes prevention programs in the same context of a Medicaid population.”

Still, practical details need to be resolved prior to real-world application, they added.

“[T]he analysis by Wheeler et al. raises an important question: Who should pay for mailed FIT screening programs?”

The answer, they suggested, may be health plans, since prevention of CRC could mitigate greater costs of care down the line. Further motivation could come from a program such as the Medicare 5-star program, which rewards higher screening rates with bonuses such as longer enrollment periods and higher payments, according to Dr. Green and Dr. Meenan.

“Unsurprisingly, Medicare CRC screening rates have been steadily increasing and now are approaching 80%,” they noted, “whereas Medicaid CRC screening rates remain low.”

The study was supported by the University of North Carolina, the Cancer Prevention and Control Research Network, the Centers for Disease Control and Prevention, and the National Cancer Institute. Dr. Wheeler reported grant funding from Pfizer.

SOURCE: Wheeler SB et al. Cancer. 2020 Jul 20. doi: 10.1002/cncr.32992.

Hemospray is highly effective for initial gastrointestinal hemostasis, but not long-term therapy, based on a recent meta-analysis.

Among 814 patients with GI bleeding who were treated with Hemospray, respective rates of clinical success and early rebleeding were 92% and 20%, reported lead author Andrew Ofosu, MD, of the Brooklyn Hospital Center, New York, and colleagues.

“Since its introduction, multiple studies have evaluated the efficacy of Hemospray for endoscopic hemostasis in a wide array of bleeding disorders in either the upper and/or lower GI tract,” the investigators wrote. Their report is in the Journal of Clinical Gastroenterology.

The present review and meta-analysis included 19 of those studies, including randomized controlled trials, case series, and case-control studies.

Of 814 adult patients, 212 were treated with Hemospray as monotherapy, while 602 were treated with Hemospray combined with conventional hemostatic techniques.

“Unlike conventional endoscopic methods currently in use to achieve immediate hemostasis in GI bleeding, Hemospray is noncontact, nonthermal, and nontraumatic,” the investigators noted.

Clinical success, defined by endoscopically observed initial hemostasis, was achieved in 91% of patients who were treated with Hemospray as monotherapy, a rate that did not significantly differ from the 93% success rate achieved by a combination approach.

Early rebleeding, defined by rebleeding within 7 days, was comparable between monotherapy (21%) and combination therapy (20%), a finding that was maintained in subgroup analysis. Similarly, no statistical difference was found between rates of rebleeding within 30 days, which were 22% and 24%, for monotherapy and combination therapy, respectively.

“Our study showed the rate of rebleeding increased with time after the application of Hemospray, likely due to the limited duration of action of the hemostatic powder at the site of bleeding,” wrote Dr. Ofosu and colleagues. “Second-look endoscopy performed in some studies has shown Hemospray is eliminated from the GI tract in as few as 24 hours after use, which potentially increases the risk of recurrent bleeding.”

The investigators suggested that Hemospray is best suited for short-term use because of the rebleeding risk.

“The use of Hemospray offers the potential to control bleeding initially and to optimize positioning or application of other modalities if needed in a more controlled setting,” concluded Dr. Ofosu and colleagues, who noted that this stance aligns with the views of other investigators.

Daljeet Chahal, MD and Fergal Donnellan, MD, of the University of British Columbia, Vancouver, are two such investigators, having just published a retrospective cohort study that involved 86 applications of Hemospray. Their study, which was not included in the present meta-analysis because of recency of publication, revealed that “Hemospray is effective in achieving immediate hemostasis but is plagued by high rates of rebleeding.”

According to Dr. Chahal and Dr. Donnellan, who provided a written comment, the findings of Dr. Ofosu and colleagues are comparable to their own, thereby supporting a similar conclusion.

“Hemospray appears more suited to emergent situations, where it should be used as a last resort; as a bridge therapy to more definitive measures such as embolization or surgery,” they wrote.

Dr. Chahal and Dr. Donnellan also suggested that more work is needed to develop a comprehensive picture of Hemospray outcomes, which could guide usage.

“The meta-analysis does not comment specifically on rates of embolization or surgery after Hemospray use, or whether these rates differ by type of lesion,” they wrote. “These would be interesting measures to explore in future studies to more concretely define appropriate indications for Hemospray use.”

Bilal Toka, MD, of Sakarya University in Serdivan, Turkey, who has previously published research comparing conventional hemostatic techniques, also provided a written comment, in which he advised clinicians to be ready for a combination approach, particularly among high-risk patients.

“This meta-analysis shows that Hemospray is very useful in providing initial hemostasis in patients with GI bleeding,” Dr. Toka wrote. “[However], due to its high early and delayed rebleeding rates, additional mechanical or thermal endoscopic treatment should be applied in high-risk lesions such as actively bleeding peptic ulcers.”

The investigators reported no conflicts of interest.

SOURCE: Ofosu A et al. J Clin Gastroenterol. 2020 Jul 3. doi: 10.1097/MCG.0000000000001379.

Hemospray is highly effective for initial gastrointestinal hemostasis, but not long-term therapy, based on a recent meta-analysis.

Among 814 patients with GI bleeding who were treated with Hemospray, respective rates of clinical success and early rebleeding were 92% and 20%, reported lead author Andrew Ofosu, MD, of the Brooklyn Hospital Center, New York, and colleagues.

“Since its introduction, multiple studies have evaluated the efficacy of Hemospray for endoscopic hemostasis in a wide array of bleeding disorders in either the upper and/or lower GI tract,” the investigators wrote. Their report is in the Journal of Clinical Gastroenterology.

The present review and meta-analysis included 19 of those studies, including randomized controlled trials, case series, and case-control studies.

Of 814 adult patients, 212 were treated with Hemospray as monotherapy, while 602 were treated with Hemospray combined with conventional hemostatic techniques.

“Unlike conventional endoscopic methods currently in use to achieve immediate hemostasis in GI bleeding, Hemospray is noncontact, nonthermal, and nontraumatic,” the investigators noted.

Clinical success, defined by endoscopically observed initial hemostasis, was achieved in 91% of patients who were treated with Hemospray as monotherapy, a rate that did not significantly differ from the 93% success rate achieved by a combination approach.

Early rebleeding, defined by rebleeding within 7 days, was comparable between monotherapy (21%) and combination therapy (20%), a finding that was maintained in subgroup analysis. Similarly, no statistical difference was found between rates of rebleeding within 30 days, which were 22% and 24%, for monotherapy and combination therapy, respectively.

“Our study showed the rate of rebleeding increased with time after the application of Hemospray, likely due to the limited duration of action of the hemostatic powder at the site of bleeding,” wrote Dr. Ofosu and colleagues. “Second-look endoscopy performed in some studies has shown Hemospray is eliminated from the GI tract in as few as 24 hours after use, which potentially increases the risk of recurrent bleeding.”

The investigators suggested that Hemospray is best suited for short-term use because of the rebleeding risk.

“The use of Hemospray offers the potential to control bleeding initially and to optimize positioning or application of other modalities if needed in a more controlled setting,” concluded Dr. Ofosu and colleagues, who noted that this stance aligns with the views of other investigators.

Daljeet Chahal, MD and Fergal Donnellan, MD, of the University of British Columbia, Vancouver, are two such investigators, having just published a retrospective cohort study that involved 86 applications of Hemospray. Their study, which was not included in the present meta-analysis because of recency of publication, revealed that “Hemospray is effective in achieving immediate hemostasis but is plagued by high rates of rebleeding.”

According to Dr. Chahal and Dr. Donnellan, who provided a written comment, the findings of Dr. Ofosu and colleagues are comparable to their own, thereby supporting a similar conclusion.

“Hemospray appears more suited to emergent situations, where it should be used as a last resort; as a bridge therapy to more definitive measures such as embolization or surgery,” they wrote.

Dr. Chahal and Dr. Donnellan also suggested that more work is needed to develop a comprehensive picture of Hemospray outcomes, which could guide usage.

“The meta-analysis does not comment specifically on rates of embolization or surgery after Hemospray use, or whether these rates differ by type of lesion,” they wrote. “These would be interesting measures to explore in future studies to more concretely define appropriate indications for Hemospray use.”

Bilal Toka, MD, of Sakarya University in Serdivan, Turkey, who has previously published research comparing conventional hemostatic techniques, also provided a written comment, in which he advised clinicians to be ready for a combination approach, particularly among high-risk patients.

“This meta-analysis shows that Hemospray is very useful in providing initial hemostasis in patients with GI bleeding,” Dr. Toka wrote. “[However], due to its high early and delayed rebleeding rates, additional mechanical or thermal endoscopic treatment should be applied in high-risk lesions such as actively bleeding peptic ulcers.”

The investigators reported no conflicts of interest.

SOURCE: Ofosu A et al. J Clin Gastroenterol. 2020 Jul 3. doi: 10.1097/MCG.0000000000001379.

Hemospray is highly effective for initial gastrointestinal hemostasis, but not long-term therapy, based on a recent meta-analysis.

Among 814 patients with GI bleeding who were treated with Hemospray, respective rates of clinical success and early rebleeding were 92% and 20%, reported lead author Andrew Ofosu, MD, of the Brooklyn Hospital Center, New York, and colleagues.

“Since its introduction, multiple studies have evaluated the efficacy of Hemospray for endoscopic hemostasis in a wide array of bleeding disorders in either the upper and/or lower GI tract,” the investigators wrote. Their report is in the Journal of Clinical Gastroenterology.

The present review and meta-analysis included 19 of those studies, including randomized controlled trials, case series, and case-control studies.

Of 814 adult patients, 212 were treated with Hemospray as monotherapy, while 602 were treated with Hemospray combined with conventional hemostatic techniques.

“Unlike conventional endoscopic methods currently in use to achieve immediate hemostasis in GI bleeding, Hemospray is noncontact, nonthermal, and nontraumatic,” the investigators noted.

Clinical success, defined by endoscopically observed initial hemostasis, was achieved in 91% of patients who were treated with Hemospray as monotherapy, a rate that did not significantly differ from the 93% success rate achieved by a combination approach.

Early rebleeding, defined by rebleeding within 7 days, was comparable between monotherapy (21%) and combination therapy (20%), a finding that was maintained in subgroup analysis. Similarly, no statistical difference was found between rates of rebleeding within 30 days, which were 22% and 24%, for monotherapy and combination therapy, respectively.

“Our study showed the rate of rebleeding increased with time after the application of Hemospray, likely due to the limited duration of action of the hemostatic powder at the site of bleeding,” wrote Dr. Ofosu and colleagues. “Second-look endoscopy performed in some studies has shown Hemospray is eliminated from the GI tract in as few as 24 hours after use, which potentially increases the risk of recurrent bleeding.”

The investigators suggested that Hemospray is best suited for short-term use because of the rebleeding risk.

“The use of Hemospray offers the potential to control bleeding initially and to optimize positioning or application of other modalities if needed in a more controlled setting,” concluded Dr. Ofosu and colleagues, who noted that this stance aligns with the views of other investigators.

Daljeet Chahal, MD and Fergal Donnellan, MD, of the University of British Columbia, Vancouver, are two such investigators, having just published a retrospective cohort study that involved 86 applications of Hemospray. Their study, which was not included in the present meta-analysis because of recency of publication, revealed that “Hemospray is effective in achieving immediate hemostasis but is plagued by high rates of rebleeding.”

According to Dr. Chahal and Dr. Donnellan, who provided a written comment, the findings of Dr. Ofosu and colleagues are comparable to their own, thereby supporting a similar conclusion.

“Hemospray appears more suited to emergent situations, where it should be used as a last resort; as a bridge therapy to more definitive measures such as embolization or surgery,” they wrote.

Dr. Chahal and Dr. Donnellan also suggested that more work is needed to develop a comprehensive picture of Hemospray outcomes, which could guide usage.

“The meta-analysis does not comment specifically on rates of embolization or surgery after Hemospray use, or whether these rates differ by type of lesion,” they wrote. “These would be interesting measures to explore in future studies to more concretely define appropriate indications for Hemospray use.”

Bilal Toka, MD, of Sakarya University in Serdivan, Turkey, who has previously published research comparing conventional hemostatic techniques, also provided a written comment, in which he advised clinicians to be ready for a combination approach, particularly among high-risk patients.

“This meta-analysis shows that Hemospray is very useful in providing initial hemostasis in patients with GI bleeding,” Dr. Toka wrote. “[However], due to its high early and delayed rebleeding rates, additional mechanical or thermal endoscopic treatment should be applied in high-risk lesions such as actively bleeding peptic ulcers.”

The investigators reported no conflicts of interest.

SOURCE: Ofosu A et al. J Clin Gastroenterol. 2020 Jul 3. doi: 10.1097/MCG.0000000000001379.

BRCA carrier status alone should not influence screening recommendations for colorectal cancer or pancreatic ductal adenocarcinoma, according to an American Gastroenterological Association clinical practice update.

Relationships between BRCA carrier status and risks of pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC) remain unclear, reported lead author Sonia S. Kupfer, MD, AGAF, of the University of Chicago, and colleagues.

“Pathogenic variants in BRCA1 and BRCA2 have ... been associated with variable risk of GI cancer, including CRC, PDAC, biliary, and gastric cancers,” the investigators wrote in Gastroenterology. “However, the magnitude of GI cancer risks is not well established and there is minimal evidence or guidance on screening for GI cancers among BRCA1 and BRCA2 carriers.”

According to the investigators, personalized screening for CRC is well supported by evidence, as higher-risk individuals, such as those with a family history of CRC, have been shown to benefit from earlier and more frequent colonoscopies. Although the value of risk-based screening is less clear for other types of GI cancer, the investigators cited a growing body of evidence that supports screening individuals at high risk of PDAC.

Still, data illuminating the role of BRCA carrier status are relatively scarce, which has led to variability in clinical practice.

“Lack of accurate CRC and PDAC risk estimates in BRCA1 and BRCA2 leave physicians and patients without guidance, and result in a range of screening recommendations and practices in this population,” wrote Dr. Kupfer and colleagues.

To offer some clarity, they drafted the present clinical practice update on behalf of the AGA. The recommendations are framed within a discussion of relevant publications.

Data from multiple studies, for instance, suggest that BRCA pathogenic variants are found in 1.3% of patients with early-onset CRC, 0.2% of those with high-risk CRC, and 1.0% of those with any type of CRC, all of which are higher rates “than would be expected by chance.

“However,” the investigators added, “this association is not proof that the observed BRCA1 and BRCA2 pathogenic variants play a causative role in CRC.”

The investigators went on to discuss a 2018 meta-analysis by Oho et al., which included 14 studies evaluating risk of CRC among BRCA carriers. The analysis found that BRCA carriers had a 24% increased risk of CRC, which Dr. Kupfer and colleagues described as “small but statistically significant.” Subgroup analysis suggested that BRCA1 carriers drove this association, with a 49% increased risk of CRC, whereas no significant link was found with BRCA2.

Dr. Kupfer and colleagues described the 49% increase as “very modest,” and therefore insufficient to warrant more intensive screening, particularly when considered in the context of other risk factors, such as Lynch syndrome, which may entail a 1,600% increased risk of CRC. For PDAC, no such meta-analysis has been conducted; however, multiple studies have pointed to associations between BRCA and risk of PDAC.

For example, a 2018 case-control study by Hu et al. showed that BRCA1 and BRCA2 had relative prevalence rates of 0.59% and 1.95% among patients with PDAC. These rates translated to a 158% increased risk of PDAC for BRCA1, and a 520% increase risk for BRCA2; but Dr. Kupfer and colleagues noted that the BRCA2 carriers were from high-risk families, so the findings may not extend to the general population.

In light of these findings, the update recommends PDAC screening for BRCA carriers only if they have a family history of PDAC, with the caveat that the association between risk and degree of family involvement remains unknown.

Ultimately, for both CRC and PDAC, the investigators called for further BRCA research, based on the conclusion that “results from published studies provide inconsistent levels of evidence.”

The investigators reported no conflicts of interest.

SOURCE: Kupfer SS et al. Gastroenterology. 2020 Apr 23. doi: 10.1053/j.gastro.2020.03.086.

BRCA carrier status alone should not influence screening recommendations for colorectal cancer or pancreatic ductal adenocarcinoma, according to an American Gastroenterological Association clinical practice update.

Relationships between BRCA carrier status and risks of pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC) remain unclear, reported lead author Sonia S. Kupfer, MD, AGAF, of the University of Chicago, and colleagues.

“Pathogenic variants in BRCA1 and BRCA2 have ... been associated with variable risk of GI cancer, including CRC, PDAC, biliary, and gastric cancers,” the investigators wrote in Gastroenterology. “However, the magnitude of GI cancer risks is not well established and there is minimal evidence or guidance on screening for GI cancers among BRCA1 and BRCA2 carriers.”

According to the investigators, personalized screening for CRC is well supported by evidence, as higher-risk individuals, such as those with a family history of CRC, have been shown to benefit from earlier and more frequent colonoscopies. Although the value of risk-based screening is less clear for other types of GI cancer, the investigators cited a growing body of evidence that supports screening individuals at high risk of PDAC.

Still, data illuminating the role of BRCA carrier status are relatively scarce, which has led to variability in clinical practice.

“Lack of accurate CRC and PDAC risk estimates in BRCA1 and BRCA2 leave physicians and patients without guidance, and result in a range of screening recommendations and practices in this population,” wrote Dr. Kupfer and colleagues.

To offer some clarity, they drafted the present clinical practice update on behalf of the AGA. The recommendations are framed within a discussion of relevant publications.

Data from multiple studies, for instance, suggest that BRCA pathogenic variants are found in 1.3% of patients with early-onset CRC, 0.2% of those with high-risk CRC, and 1.0% of those with any type of CRC, all of which are higher rates “than would be expected by chance.

“However,” the investigators added, “this association is not proof that the observed BRCA1 and BRCA2 pathogenic variants play a causative role in CRC.”

The investigators went on to discuss a 2018 meta-analysis by Oho et al., which included 14 studies evaluating risk of CRC among BRCA carriers. The analysis found that BRCA carriers had a 24% increased risk of CRC, which Dr. Kupfer and colleagues described as “small but statistically significant.” Subgroup analysis suggested that BRCA1 carriers drove this association, with a 49% increased risk of CRC, whereas no significant link was found with BRCA2.

Dr. Kupfer and colleagues described the 49% increase as “very modest,” and therefore insufficient to warrant more intensive screening, particularly when considered in the context of other risk factors, such as Lynch syndrome, which may entail a 1,600% increased risk of CRC. For PDAC, no such meta-analysis has been conducted; however, multiple studies have pointed to associations between BRCA and risk of PDAC.

For example, a 2018 case-control study by Hu et al. showed that BRCA1 and BRCA2 had relative prevalence rates of 0.59% and 1.95% among patients with PDAC. These rates translated to a 158% increased risk of PDAC for BRCA1, and a 520% increase risk for BRCA2; but Dr. Kupfer and colleagues noted that the BRCA2 carriers were from high-risk families, so the findings may not extend to the general population.

In light of these findings, the update recommends PDAC screening for BRCA carriers only if they have a family history of PDAC, with the caveat that the association between risk and degree of family involvement remains unknown.

Ultimately, for both CRC and PDAC, the investigators called for further BRCA research, based on the conclusion that “results from published studies provide inconsistent levels of evidence.”

The investigators reported no conflicts of interest.

SOURCE: Kupfer SS et al. Gastroenterology. 2020 Apr 23. doi: 10.1053/j.gastro.2020.03.086.

BRCA carrier status alone should not influence screening recommendations for colorectal cancer or pancreatic ductal adenocarcinoma, according to an American Gastroenterological Association clinical practice update.

Relationships between BRCA carrier status and risks of pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC) remain unclear, reported lead author Sonia S. Kupfer, MD, AGAF, of the University of Chicago, and colleagues.

“Pathogenic variants in BRCA1 and BRCA2 have ... been associated with variable risk of GI cancer, including CRC, PDAC, biliary, and gastric cancers,” the investigators wrote in Gastroenterology. “However, the magnitude of GI cancer risks is not well established and there is minimal evidence or guidance on screening for GI cancers among BRCA1 and BRCA2 carriers.”

According to the investigators, personalized screening for CRC is well supported by evidence, as higher-risk individuals, such as those with a family history of CRC, have been shown to benefit from earlier and more frequent colonoscopies. Although the value of risk-based screening is less clear for other types of GI cancer, the investigators cited a growing body of evidence that supports screening individuals at high risk of PDAC.

Still, data illuminating the role of BRCA carrier status are relatively scarce, which has led to variability in clinical practice.

“Lack of accurate CRC and PDAC risk estimates in BRCA1 and BRCA2 leave physicians and patients without guidance, and result in a range of screening recommendations and practices in this population,” wrote Dr. Kupfer and colleagues.

To offer some clarity, they drafted the present clinical practice update on behalf of the AGA. The recommendations are framed within a discussion of relevant publications.

Data from multiple studies, for instance, suggest that BRCA pathogenic variants are found in 1.3% of patients with early-onset CRC, 0.2% of those with high-risk CRC, and 1.0% of those with any type of CRC, all of which are higher rates “than would be expected by chance.

“However,” the investigators added, “this association is not proof that the observed BRCA1 and BRCA2 pathogenic variants play a causative role in CRC.”

The investigators went on to discuss a 2018 meta-analysis by Oho et al., which included 14 studies evaluating risk of CRC among BRCA carriers. The analysis found that BRCA carriers had a 24% increased risk of CRC, which Dr. Kupfer and colleagues described as “small but statistically significant.” Subgroup analysis suggested that BRCA1 carriers drove this association, with a 49% increased risk of CRC, whereas no significant link was found with BRCA2.

Dr. Kupfer and colleagues described the 49% increase as “very modest,” and therefore insufficient to warrant more intensive screening, particularly when considered in the context of other risk factors, such as Lynch syndrome, which may entail a 1,600% increased risk of CRC. For PDAC, no such meta-analysis has been conducted; however, multiple studies have pointed to associations between BRCA and risk of PDAC.

For example, a 2018 case-control study by Hu et al. showed that BRCA1 and BRCA2 had relative prevalence rates of 0.59% and 1.95% among patients with PDAC. These rates translated to a 158% increased risk of PDAC for BRCA1, and a 520% increase risk for BRCA2; but Dr. Kupfer and colleagues noted that the BRCA2 carriers were from high-risk families, so the findings may not extend to the general population.

In light of these findings, the update recommends PDAC screening for BRCA carriers only if they have a family history of PDAC, with the caveat that the association between risk and degree of family involvement remains unknown.

Ultimately, for both CRC and PDAC, the investigators called for further BRCA research, based on the conclusion that “results from published studies provide inconsistent levels of evidence.”

The investigators reported no conflicts of interest.

SOURCE: Kupfer SS et al. Gastroenterology. 2020 Apr 23. doi: 10.1053/j.gastro.2020.03.086.

The role of probiotics in the management of gastrointestinal disorders remains largely unclear, according to a clinical practice guideline published by the American Gastroenterological Association (AGA).

Out of eight disorders reviewed by the guideline panel, four had enough relevant data to support conditional recommendations, while the other four were associated with knowledge gaps that precluded guidance, reported lead author Grace L. Su, MD, AGAF, of the University of Michigan, Ann Arbor, and colleagues.

“It is estimated that 3.9 million American adults used some form of probiotics or prebiotics ... in 2015, an amount which is four times that in 2007,” the guideline panelists wrote. Their report is in Gastroenterology. “Given widespread use and often biased sources of information, it is essential that clinicians have objective guidance for their patients about the appropriate use of and indications for probiotics.”

The creation of such guidance, however, proved a challenging task for the panel, who faced an “extremely varied” evidence base.

Dr. Su and colleagues, who were selected by the AGA Governing Board and Clinical Guidelines Committee, encountered “differences in the strain of microbe(s) used, dose, and route of administration.”

They noted that such differences can significantly affect clinical outcomes.

“Within species, different strains can have widely different activities and biologic effects,” they wrote. “Many immunologic, neurologic, and biochemical effects of gut microbiota are likely not only to be strain specific, but also dose specific. Furthermore, combinations of different microbial strains may also have widely different activity as some microbial activities are dependent on interactions between different strains.”

Beyond differences in treatments, the investigators also reported wide variability in endpoints and outcomes, as well as relatively small study populations compared with pharmacological trials.

Still, data were sufficient to provide some conditional recommendations.

The guideline supports probiotics for patients with pouchitis, those receiving antibiotic therapy, and preterm/low-birthweight infants. In contrast, the panel recommended against probiotics for children with acute infectious gastroenteritis, noting that this recommendation differs from those made by other medical organizations.

“While other society guidelines have previously recommended the use of probiotics in [children with acute infectious gastroenteritis], these guidelines were developed without utilizing GRADE methodology and also relied on data outside of North America which became available after the recommendations were made,” wrote Dr. Su and colleagues. They described a moderate quality of evidence relevant to this indication.

In comparison, the quality of evidence was very low for patients with pouchitis, low for those receiving antibiotics, and moderate/high for preterm/low-birthweight infants.

For Clostridioides difficile infection, Crohn’s disease, ulcerative colitis, and irritable bowel syndrome, the panel recommended probiotics only in the context of a clinical trial, citing knowledge gaps in these areas.

They also noted that probiotics may not be suitable for those at high risk of infection.

“[F]or patients who place a high value on avoidance of potential harms, particularly those with severe illnesses or immunosuppression, it would be reasonable to select not to use probiotics,” the panelists wrote.

Concluding their discussion, Dr. Su and colleagues called for more high-quality research.

“We identified that significant knowledge gaps exist in this very promising and important area of research due to the significant heterogeneity between studies and variability in the probiotic strains studied,” they wrote. “The lack of consistent harms reporting makes it difficult to assess true harms. The lack of product manufacturing details prohibits true comparisons and decreases the feasibility of obtaining certain products by patients. Future high-quality studies are urgently needed which address these pitfalls.”

According to the panelists, the probiotic guideline will be updated in 3-5 years, or possibly earlier if practice-altering findings are published.

The investigators disclosed relationships with Nestex, AbbVie, Takeda, and others.

The role of probiotics in the management of gastrointestinal disorders remains largely unclear, according to a clinical practice guideline published by the American Gastroenterological Association (AGA).

Out of eight disorders reviewed by the guideline panel, four had enough relevant data to support conditional recommendations, while the other four were associated with knowledge gaps that precluded guidance, reported lead author Grace L. Su, MD, AGAF, of the University of Michigan, Ann Arbor, and colleagues.

“It is estimated that 3.9 million American adults used some form of probiotics or prebiotics ... in 2015, an amount which is four times that in 2007,” the guideline panelists wrote. Their report is in Gastroenterology. “Given widespread use and often biased sources of information, it is essential that clinicians have objective guidance for their patients about the appropriate use of and indications for probiotics.”

The creation of such guidance, however, proved a challenging task for the panel, who faced an “extremely varied” evidence base.

Dr. Su and colleagues, who were selected by the AGA Governing Board and Clinical Guidelines Committee, encountered “differences in the strain of microbe(s) used, dose, and route of administration.”

They noted that such differences can significantly affect clinical outcomes.

“Within species, different strains can have widely different activities and biologic effects,” they wrote. “Many immunologic, neurologic, and biochemical effects of gut microbiota are likely not only to be strain specific, but also dose specific. Furthermore, combinations of different microbial strains may also have widely different activity as some microbial activities are dependent on interactions between different strains.”

Beyond differences in treatments, the investigators also reported wide variability in endpoints and outcomes, as well as relatively small study populations compared with pharmacological trials.

Still, data were sufficient to provide some conditional recommendations.

The guideline supports probiotics for patients with pouchitis, those receiving antibiotic therapy, and preterm/low-birthweight infants. In contrast, the panel recommended against probiotics for children with acute infectious gastroenteritis, noting that this recommendation differs from those made by other medical organizations.

“While other society guidelines have previously recommended the use of probiotics in [children with acute infectious gastroenteritis], these guidelines were developed without utilizing GRADE methodology and also relied on data outside of North America which became available after the recommendations were made,” wrote Dr. Su and colleagues. They described a moderate quality of evidence relevant to this indication.

In comparison, the quality of evidence was very low for patients with pouchitis, low for those receiving antibiotics, and moderate/high for preterm/low-birthweight infants.

For Clostridioides difficile infection, Crohn’s disease, ulcerative colitis, and irritable bowel syndrome, the panel recommended probiotics only in the context of a clinical trial, citing knowledge gaps in these areas.

They also noted that probiotics may not be suitable for those at high risk of infection.

“[F]or patients who place a high value on avoidance of potential harms, particularly those with severe illnesses or immunosuppression, it would be reasonable to select not to use probiotics,” the panelists wrote.

Concluding their discussion, Dr. Su and colleagues called for more high-quality research.

“We identified that significant knowledge gaps exist in this very promising and important area of research due to the significant heterogeneity between studies and variability in the probiotic strains studied,” they wrote. “The lack of consistent harms reporting makes it difficult to assess true harms. The lack of product manufacturing details prohibits true comparisons and decreases the feasibility of obtaining certain products by patients. Future high-quality studies are urgently needed which address these pitfalls.”

According to the panelists, the probiotic guideline will be updated in 3-5 years, or possibly earlier if practice-altering findings are published.

The investigators disclosed relationships with Nestex, AbbVie, Takeda, and others.

The role of probiotics in the management of gastrointestinal disorders remains largely unclear, according to a clinical practice guideline published by the American Gastroenterological Association (AGA).

Out of eight disorders reviewed by the guideline panel, four had enough relevant data to support conditional recommendations, while the other four were associated with knowledge gaps that precluded guidance, reported lead author Grace L. Su, MD, AGAF, of the University of Michigan, Ann Arbor, and colleagues.

“It is estimated that 3.9 million American adults used some form of probiotics or prebiotics ... in 2015, an amount which is four times that in 2007,” the guideline panelists wrote. Their report is in Gastroenterology. “Given widespread use and often biased sources of information, it is essential that clinicians have objective guidance for their patients about the appropriate use of and indications for probiotics.”

The creation of such guidance, however, proved a challenging task for the panel, who faced an “extremely varied” evidence base.

Dr. Su and colleagues, who were selected by the AGA Governing Board and Clinical Guidelines Committee, encountered “differences in the strain of microbe(s) used, dose, and route of administration.”

They noted that such differences can significantly affect clinical outcomes.

“Within species, different strains can have widely different activities and biologic effects,” they wrote. “Many immunologic, neurologic, and biochemical effects of gut microbiota are likely not only to be strain specific, but also dose specific. Furthermore, combinations of different microbial strains may also have widely different activity as some microbial activities are dependent on interactions between different strains.”

Beyond differences in treatments, the investigators also reported wide variability in endpoints and outcomes, as well as relatively small study populations compared with pharmacological trials.

Still, data were sufficient to provide some conditional recommendations.

The guideline supports probiotics for patients with pouchitis, those receiving antibiotic therapy, and preterm/low-birthweight infants. In contrast, the panel recommended against probiotics for children with acute infectious gastroenteritis, noting that this recommendation differs from those made by other medical organizations.

“While other society guidelines have previously recommended the use of probiotics in [children with acute infectious gastroenteritis], these guidelines were developed without utilizing GRADE methodology and also relied on data outside of North America which became available after the recommendations were made,” wrote Dr. Su and colleagues. They described a moderate quality of evidence relevant to this indication.

In comparison, the quality of evidence was very low for patients with pouchitis, low for those receiving antibiotics, and moderate/high for preterm/low-birthweight infants.

For Clostridioides difficile infection, Crohn’s disease, ulcerative colitis, and irritable bowel syndrome, the panel recommended probiotics only in the context of a clinical trial, citing knowledge gaps in these areas.

They also noted that probiotics may not be suitable for those at high risk of infection.

“[F]or patients who place a high value on avoidance of potential harms, particularly those with severe illnesses or immunosuppression, it would be reasonable to select not to use probiotics,” the panelists wrote.

Concluding their discussion, Dr. Su and colleagues called for more high-quality research.

“We identified that significant knowledge gaps exist in this very promising and important area of research due to the significant heterogeneity between studies and variability in the probiotic strains studied,” they wrote. “The lack of consistent harms reporting makes it difficult to assess true harms. The lack of product manufacturing details prohibits true comparisons and decreases the feasibility of obtaining certain products by patients. Future high-quality studies are urgently needed which address these pitfalls.”

According to the panelists, the probiotic guideline will be updated in 3-5 years, or possibly earlier if practice-altering findings are published.

The investigators disclosed relationships with Nestex, AbbVie, Takeda, and others.

The American Gastroenterological Association has released a new guideline for consultative management of patients with COVID-19.

The recommendations, which were written by Shahnaz Sultan, MD, AGAF, chair of the AGA Clinical Guidelines Committee, of the University of Minnesota, Minneapolis, and colleagues, were based on a meta-analysis of data from 47 studies involving 10,890 unique patients.

“We seek to summarize international data on the GI and liver manifestations of COVID-19 infection and treatment,” the panelists wrote in Gastroenterology. “Additionally, this document provides evidence-based clinical guidance on clinical questions that gastroenterologists may be consulted for.”

The guideline includes seven best practice statements.

The first three statements relate to COVID-19–related GI symptoms, which are estimated to occur in less than 10% of patients, and rarely in the absence of other COVID-19–related symptoms, according to Dr. Sultan and her copanelists.

“The overall prevalence of GI symptoms in the context of COVID-19, including nausea, vomiting, abdominal pain, and diarrhea, is lower than estimated previously,” the panelists wrote, referencing a previous meta-analysis by Ka Shing Cheung, MBBS, and colleagues that showed a prevalence of 17.6%.

“It is important to note that the majority of studies were focused on hospitalized patients with COVID-19, and the prevalence of diarrhea in patients with mild symptoms who were not hospitalized is not known.”

Since GI issues may precede other symptoms of COVID-19, the guideline recommends questioning outpatients with new-onset GI symptoms about other symptoms of COVID-19, with viral testing recommended in areas of high prevalence. Conversely, the panelists recommended that patients with suspected or known COVID-19 should undergo thorough history taking for GI symptoms, “including onset, characteristics, duration, and severity.”

The fourth practice statement advises against COVID-19 stool testing in routine clinical practice, either for diagnostic or monitoring purposes.

Although Dr. Cheung and colleagues reported that 48.1% of fecal specimens from patients with COVID-19 contained viral RNA, the panelists concluded that the practical relevance of this finding remains unknown.

“Stool infectivity and transmission have not been confirmed,” the panelists wrote, citing a lack of evidence and conflicting findings.

The final three practice statements address liver concerns.

First, any patient with suspected or confirmed COVID-19 who has elevated liver function tests should be evaluated for alternative etiologies. Second, hospitalized patients with suspected or confirmed COVID-19 should undergo baseline liver function testing, followed by liver monitoring throughout their stay, “particularly in the context of drug treatment for COVID-19.” And third, any patient receiving drugs to treat COVID-19 should be monitored for treatment-related hepatic and GI adverse effects.

Dr. Sultan and colleagues found that approximately 15% of patients with COVID-19 included in their meta-analysis had abnormal liver function tests, more often because of secondary effects rather than virally induced liver injury.

Although liver function test abnormalities were inconsistently reported across studies, and when available, often lacked relevant contextual data, such as information about underlying liver disease, published data suggest that abnormal liver values could predict more severe COVID-19, supporting baseline and serial liver testing, the panelists wrote.

Following these recommendations, the guideline includes a discussion of GI and hepatic adverse effects related to specific COVID-19 treatments.

According to the panelists, chloroquine and hydroxychloroquine may infrequently lead to GI disturbances, and rarely, liver injury, with the latter thought to be a sequela of a hypersensitivity reaction; among antiviral medications, lopinavir/ritonavir and favipiravir may cause GI adverse effects in approximately 5%-15% of patients, with potentially higher rates in children and those receiving higher doses.

“In particular, GI adverse events are poorly understood for both favipiravir and remdesivir,” the panelists wrote.

Hepatic adverse effects, ranging from mild elevations in aminotransferases to acute liver failure, have been documented, albeit rarely, among patients receiving lopinavir/ritonavir, according to the panelists. For remdesivir, liver injury has also been reported, although frequency is unknown, and for favipiravir, hepatic adverse events may be seen in 3% of patients, although, again, the panelists noted a scarcity of relevant findings.

In their concluding remarks, Dr. Sultan and colleagues called for more high-quality data, and encouraged clinicians to contribute to international registries, as these could help guide COVID-19 recommendations for patient subgroups.

The article was funded by the American Gastroenterological Association Institute.

SOURCE: Sultan S et al. Gastroenterology. 2020 May 11. doi: 10.1053/j.gastro.2020.05.001.

The American Gastroenterological Association has released a new guideline for consultative management of patients with COVID-19.

The recommendations, which were written by Shahnaz Sultan, MD, AGAF, chair of the AGA Clinical Guidelines Committee, of the University of Minnesota, Minneapolis, and colleagues, were based on a meta-analysis of data from 47 studies involving 10,890 unique patients.

“We seek to summarize international data on the GI and liver manifestations of COVID-19 infection and treatment,” the panelists wrote in Gastroenterology. “Additionally, this document provides evidence-based clinical guidance on clinical questions that gastroenterologists may be consulted for.”

The guideline includes seven best practice statements.

The first three statements relate to COVID-19–related GI symptoms, which are estimated to occur in less than 10% of patients, and rarely in the absence of other COVID-19–related symptoms, according to Dr. Sultan and her copanelists.

“The overall prevalence of GI symptoms in the context of COVID-19, including nausea, vomiting, abdominal pain, and diarrhea, is lower than estimated previously,” the panelists wrote, referencing a previous meta-analysis by Ka Shing Cheung, MBBS, and colleagues that showed a prevalence of 17.6%.

“It is important to note that the majority of studies were focused on hospitalized patients with COVID-19, and the prevalence of diarrhea in patients with mild symptoms who were not hospitalized is not known.”

Since GI issues may precede other symptoms of COVID-19, the guideline recommends questioning outpatients with new-onset GI symptoms about other symptoms of COVID-19, with viral testing recommended in areas of high prevalence. Conversely, the panelists recommended that patients with suspected or known COVID-19 should undergo thorough history taking for GI symptoms, “including onset, characteristics, duration, and severity.”

The fourth practice statement advises against COVID-19 stool testing in routine clinical practice, either for diagnostic or monitoring purposes.

Although Dr. Cheung and colleagues reported that 48.1% of fecal specimens from patients with COVID-19 contained viral RNA, the panelists concluded that the practical relevance of this finding remains unknown.

“Stool infectivity and transmission have not been confirmed,” the panelists wrote, citing a lack of evidence and conflicting findings.

The final three practice statements address liver concerns.

First, any patient with suspected or confirmed COVID-19 who has elevated liver function tests should be evaluated for alternative etiologies. Second, hospitalized patients with suspected or confirmed COVID-19 should undergo baseline liver function testing, followed by liver monitoring throughout their stay, “particularly in the context of drug treatment for COVID-19.” And third, any patient receiving drugs to treat COVID-19 should be monitored for treatment-related hepatic and GI adverse effects.

Dr. Sultan and colleagues found that approximately 15% of patients with COVID-19 included in their meta-analysis had abnormal liver function tests, more often because of secondary effects rather than virally induced liver injury.

Although liver function test abnormalities were inconsistently reported across studies, and when available, often lacked relevant contextual data, such as information about underlying liver disease, published data suggest that abnormal liver values could predict more severe COVID-19, supporting baseline and serial liver testing, the panelists wrote.

Following these recommendations, the guideline includes a discussion of GI and hepatic adverse effects related to specific COVID-19 treatments.

According to the panelists, chloroquine and hydroxychloroquine may infrequently lead to GI disturbances, and rarely, liver injury, with the latter thought to be a sequela of a hypersensitivity reaction; among antiviral medications, lopinavir/ritonavir and favipiravir may cause GI adverse effects in approximately 5%-15% of patients, with potentially higher rates in children and those receiving higher doses.

“In particular, GI adverse events are poorly understood for both favipiravir and remdesivir,” the panelists wrote.

Hepatic adverse effects, ranging from mild elevations in aminotransferases to acute liver failure, have been documented, albeit rarely, among patients receiving lopinavir/ritonavir, according to the panelists. For remdesivir, liver injury has also been reported, although frequency is unknown, and for favipiravir, hepatic adverse events may be seen in 3% of patients, although, again, the panelists noted a scarcity of relevant findings.

In their concluding remarks, Dr. Sultan and colleagues called for more high-quality data, and encouraged clinicians to contribute to international registries, as these could help guide COVID-19 recommendations for patient subgroups.

The article was funded by the American Gastroenterological Association Institute.

SOURCE: Sultan S et al. Gastroenterology. 2020 May 11. doi: 10.1053/j.gastro.2020.05.001.

The American Gastroenterological Association has released a new guideline for consultative management of patients with COVID-19.

The recommendations, which were written by Shahnaz Sultan, MD, AGAF, chair of the AGA Clinical Guidelines Committee, of the University of Minnesota, Minneapolis, and colleagues, were based on a meta-analysis of data from 47 studies involving 10,890 unique patients.

“We seek to summarize international data on the GI and liver manifestations of COVID-19 infection and treatment,” the panelists wrote in Gastroenterology. “Additionally, this document provides evidence-based clinical guidance on clinical questions that gastroenterologists may be consulted for.”

The guideline includes seven best practice statements.

The first three statements relate to COVID-19–related GI symptoms, which are estimated to occur in less than 10% of patients, and rarely in the absence of other COVID-19–related symptoms, according to Dr. Sultan and her copanelists.

“The overall prevalence of GI symptoms in the context of COVID-19, including nausea, vomiting, abdominal pain, and diarrhea, is lower than estimated previously,” the panelists wrote, referencing a previous meta-analysis by Ka Shing Cheung, MBBS, and colleagues that showed a prevalence of 17.6%.

“It is important to note that the majority of studies were focused on hospitalized patients with COVID-19, and the prevalence of diarrhea in patients with mild symptoms who were not hospitalized is not known.”

Since GI issues may precede other symptoms of COVID-19, the guideline recommends questioning outpatients with new-onset GI symptoms about other symptoms of COVID-19, with viral testing recommended in areas of high prevalence. Conversely, the panelists recommended that patients with suspected or known COVID-19 should undergo thorough history taking for GI symptoms, “including onset, characteristics, duration, and severity.”

The fourth practice statement advises against COVID-19 stool testing in routine clinical practice, either for diagnostic or monitoring purposes.

Although Dr. Cheung and colleagues reported that 48.1% of fecal specimens from patients with COVID-19 contained viral RNA, the panelists concluded that the practical relevance of this finding remains unknown.

“Stool infectivity and transmission have not been confirmed,” the panelists wrote, citing a lack of evidence and conflicting findings.

The final three practice statements address liver concerns.

First, any patient with suspected or confirmed COVID-19 who has elevated liver function tests should be evaluated for alternative etiologies. Second, hospitalized patients with suspected or confirmed COVID-19 should undergo baseline liver function testing, followed by liver monitoring throughout their stay, “particularly in the context of drug treatment for COVID-19.” And third, any patient receiving drugs to treat COVID-19 should be monitored for treatment-related hepatic and GI adverse effects.

Dr. Sultan and colleagues found that approximately 15% of patients with COVID-19 included in their meta-analysis had abnormal liver function tests, more often because of secondary effects rather than virally induced liver injury.

Although liver function test abnormalities were inconsistently reported across studies, and when available, often lacked relevant contextual data, such as information about underlying liver disease, published data suggest that abnormal liver values could predict more severe COVID-19, supporting baseline and serial liver testing, the panelists wrote.

Following these recommendations, the guideline includes a discussion of GI and hepatic adverse effects related to specific COVID-19 treatments.

According to the panelists, chloroquine and hydroxychloroquine may infrequently lead to GI disturbances, and rarely, liver injury, with the latter thought to be a sequela of a hypersensitivity reaction; among antiviral medications, lopinavir/ritonavir and favipiravir may cause GI adverse effects in approximately 5%-15% of patients, with potentially higher rates in children and those receiving higher doses.

“In particular, GI adverse events are poorly understood for both favipiravir and remdesivir,” the panelists wrote.

Hepatic adverse effects, ranging from mild elevations in aminotransferases to acute liver failure, have been documented, albeit rarely, among patients receiving lopinavir/ritonavir, according to the panelists. For remdesivir, liver injury has also been reported, although frequency is unknown, and for favipiravir, hepatic adverse events may be seen in 3% of patients, although, again, the panelists noted a scarcity of relevant findings.

In their concluding remarks, Dr. Sultan and colleagues called for more high-quality data, and encouraged clinicians to contribute to international registries, as these could help guide COVID-19 recommendations for patient subgroups.

The article was funded by the American Gastroenterological Association Institute.

SOURCE: Sultan S et al. Gastroenterology. 2020 May 11. doi: 10.1053/j.gastro.2020.05.001.