Guidelines

A new statement from the American College of Cardiology is calling for a greater degree of career flexibility in the specialty to promote cardiologists’ personal and professional well-being and preserve excellence in patient care.

The statement recommends that cardiologists, from trainees to those contemplating retirement, be granted more leeway in their careers to allow them to take time for common life events, such as child-rearing, taking care of aged parents, or reducing their workload in case of poor health or physical disabilities, without jeopardizing their careers.

The “2022 ACC Health Policy Statement on Career Flexibility in Cardiology: A Report of the American College of Cardiology Solution Set Oversight Committee” was published online in the Journal of the American College of Cardiology.
 

‘Hard-driving profession’

The well-being of the cardiovascular workforce is critical to the achievement of the mission of the ACC, which is to transform cardiovascular care and improve heart health, the Health Policy writing committee stated. Career flexibility is an important component of ensuring that well-being, the authors wrote.

“The ACC has critically looked at the factors that contribute to the lack of diversity and inclusion in cardiovascular practice, and one of the issues is the lack of flexibility in our profession,” writing committee chair, Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation programs, Ascension St. Vincent Heart Center, Indianapolis, Ind., told this news organization.

The notion of work-life balance has become increasingly important but cardiology as a profession has traditionally not been open to the idea of its value, Dr. Walsh said.

“We have a very hard-driving profession. It takes many years to train to do the work we do. The need for on-call services is very significant, and we go along because we have always done it this way, but if you don’t reexamine the way that you are structuring your work, you’ll never change it,” she said.

“For example, the ‘full time, full call, come to work after you’ve been up all night’ work ethic, which is no longer allowed for trainees, is still in effect once you get into university practice or clinical practice. We have interventional cardiologists up all night doing STEMI care for patients and then having a full clinic the next day,” Dr. Walsh said. “The changes that came about for trainees have not trickled up to the faculty or clinical practice level. It’s really a patient safety issue.”

She emphasized that the new policy statement is not focused solely on women. “The need for time away or flexible time around family planning, childbirth, and parental leave is increasingly important to our younger colleagues, both men and women.”

Dr. Walsh pointed out that the writing committee was carefully composed to include representation from all stakeholders.

“We have representation from very young cardiologists, one of whom was in training at the time we began our work. We have two systems CEOs who are cardiologists, we have a chair of medicine, we have two very senior cardiologists, and someone who works in industry,” she said.

The ACC also believes that cardiologists with physically demanding roles should have pathways to transition into other opportunities in patient care, research, or education.

“Right now, there are many cardiology practices that have traditional policies, where you are either all in, or you are all out. They do not allow for what we term a ‘step down’ policy, where you perhaps stop going into the cath lab, but you still do clinic and see patients,” Dr. Walsh noted.

“One of the goals of this policy statement is to allow for such practices to look at their compensation and structure, and to realize that their most senior cardiologists may be willing to stay on for several more years and be contributing members to the practice, but they may no longer wish to stay in the cath lab or be in the night call pool,” she said.

Transparency around compensation is also very important because cardiologists contemplating a reduced work schedule need to know how this will affect the amount of money they will be earning, she added.

“Transparency about policies around compensation are crucial because if an individual cardiologist wishes to pursue a flexible scheduling at any time in their career, it’s clear that they won’t have the same compensation as someone who is a full-time employee. All of this has to be very transparent and clear on both sides, so that the person deciding toward some flexibility understands what the implications are from a financial and compensation standpoint,” Dr. Walsh said.

As an example, a senior career cardiologist who no longer wants to take night calls should know what this may cost financially.

“The practice should set a valuation of night calls, so that the individual who makes the choice to step out of the call pool understands what the impact on their compensation will be. That type of transparency is necessary for all to ensure that individuals who seek flexibility will not be blindsided by the resulting decrease in financial compensation,” she said.
 

A growing need

“In its new health policy statement, the American College of Cardiology addresses the growing need for career flexibility as an important component of ensuring the well-being of the cardiovascular care workforce,” Harlan M. Krumholz, MD, SM, Harold H. Hines Jr. Professor of Medicine and professor in the Institute for Social and Policy Studies at Yale University, New Haven, Conn., told this news organization.

Courtesy Yale University

“The writing committee reviews opportunities for offering flexibility at all career levels to combat burnout and increase retention in the field, as well as proposes system, policy, and practice solutions to allow both men and women to emphasize and embrace work-life balance,” Dr. Krumholz said.

“The document provides pathways for cardiologists looking to pursue other interests or career transitions while maintaining excellence in clinical care,” he added. “Chief among these recommendations are flexible/part-time hours, leave and reentry policies, changes in job descriptions to support overarching cultural change, and equitable compensation and opportunities. The document is intended to be used as a guide for innovation in the cardiology workforce.”
 

‘Thoughtful and long overdue’

“This policy statement is thoughtful and long overdue,” Steven E. Nissen, MD, Lewis and Patricia Dickey Chair in Cardiovascular Medicine and professor of medicine at Cleveland Clinic, told this news organization.

“Career flexibility will allow cardiologists to fulfill family responsibilities while continuing to advance their careers. Successfully contributing to patient care and research does not require physicians to isolate themselves from all their other responsibilities,” Dr. Nissen added.

“I am pleased that the ACC has articulated the value of a balanced approach to career and family.”

Dr. Walsh, Dr. Krumholz, and Dr. Nissen report no relevant financial relationships.

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

A new statement from the American College of Cardiology is calling for a greater degree of career flexibility in the specialty to promote cardiologists’ personal and professional well-being and preserve excellence in patient care.

The statement recommends that cardiologists, from trainees to those contemplating retirement, be granted more leeway in their careers to allow them to take time for common life events, such as child-rearing, taking care of aged parents, or reducing their workload in case of poor health or physical disabilities, without jeopardizing their careers.

The “2022 ACC Health Policy Statement on Career Flexibility in Cardiology: A Report of the American College of Cardiology Solution Set Oversight Committee” was published online in the Journal of the American College of Cardiology.
 

‘Hard-driving profession’

The well-being of the cardiovascular workforce is critical to the achievement of the mission of the ACC, which is to transform cardiovascular care and improve heart health, the Health Policy writing committee stated. Career flexibility is an important component of ensuring that well-being, the authors wrote.

“The ACC has critically looked at the factors that contribute to the lack of diversity and inclusion in cardiovascular practice, and one of the issues is the lack of flexibility in our profession,” writing committee chair, Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation programs, Ascension St. Vincent Heart Center, Indianapolis, Ind., told this news organization.

The notion of work-life balance has become increasingly important but cardiology as a profession has traditionally not been open to the idea of its value, Dr. Walsh said.

“We have a very hard-driving profession. It takes many years to train to do the work we do. The need for on-call services is very significant, and we go along because we have always done it this way, but if you don’t reexamine the way that you are structuring your work, you’ll never change it,” she said.

“For example, the ‘full time, full call, come to work after you’ve been up all night’ work ethic, which is no longer allowed for trainees, is still in effect once you get into university practice or clinical practice. We have interventional cardiologists up all night doing STEMI care for patients and then having a full clinic the next day,” Dr. Walsh said. “The changes that came about for trainees have not trickled up to the faculty or clinical practice level. It’s really a patient safety issue.”

She emphasized that the new policy statement is not focused solely on women. “The need for time away or flexible time around family planning, childbirth, and parental leave is increasingly important to our younger colleagues, both men and women.”

Dr. Walsh pointed out that the writing committee was carefully composed to include representation from all stakeholders.

“We have representation from very young cardiologists, one of whom was in training at the time we began our work. We have two systems CEOs who are cardiologists, we have a chair of medicine, we have two very senior cardiologists, and someone who works in industry,” she said.

The ACC also believes that cardiologists with physically demanding roles should have pathways to transition into other opportunities in patient care, research, or education.

“Right now, there are many cardiology practices that have traditional policies, where you are either all in, or you are all out. They do not allow for what we term a ‘step down’ policy, where you perhaps stop going into the cath lab, but you still do clinic and see patients,” Dr. Walsh noted.

“One of the goals of this policy statement is to allow for such practices to look at their compensation and structure, and to realize that their most senior cardiologists may be willing to stay on for several more years and be contributing members to the practice, but they may no longer wish to stay in the cath lab or be in the night call pool,” she said.

Transparency around compensation is also very important because cardiologists contemplating a reduced work schedule need to know how this will affect the amount of money they will be earning, she added.

“Transparency about policies around compensation are crucial because if an individual cardiologist wishes to pursue a flexible scheduling at any time in their career, it’s clear that they won’t have the same compensation as someone who is a full-time employee. All of this has to be very transparent and clear on both sides, so that the person deciding toward some flexibility understands what the implications are from a financial and compensation standpoint,” Dr. Walsh said.

As an example, a senior career cardiologist who no longer wants to take night calls should know what this may cost financially.

“The practice should set a valuation of night calls, so that the individual who makes the choice to step out of the call pool understands what the impact on their compensation will be. That type of transparency is necessary for all to ensure that individuals who seek flexibility will not be blindsided by the resulting decrease in financial compensation,” she said.
 

A growing need

“In its new health policy statement, the American College of Cardiology addresses the growing need for career flexibility as an important component of ensuring the well-being of the cardiovascular care workforce,” Harlan M. Krumholz, MD, SM, Harold H. Hines Jr. Professor of Medicine and professor in the Institute for Social and Policy Studies at Yale University, New Haven, Conn., told this news organization.

Courtesy Yale University

“The writing committee reviews opportunities for offering flexibility at all career levels to combat burnout and increase retention in the field, as well as proposes system, policy, and practice solutions to allow both men and women to emphasize and embrace work-life balance,” Dr. Krumholz said.

“The document provides pathways for cardiologists looking to pursue other interests or career transitions while maintaining excellence in clinical care,” he added. “Chief among these recommendations are flexible/part-time hours, leave and reentry policies, changes in job descriptions to support overarching cultural change, and equitable compensation and opportunities. The document is intended to be used as a guide for innovation in the cardiology workforce.”
 

‘Thoughtful and long overdue’

“This policy statement is thoughtful and long overdue,” Steven E. Nissen, MD, Lewis and Patricia Dickey Chair in Cardiovascular Medicine and professor of medicine at Cleveland Clinic, told this news organization.

“Career flexibility will allow cardiologists to fulfill family responsibilities while continuing to advance their careers. Successfully contributing to patient care and research does not require physicians to isolate themselves from all their other responsibilities,” Dr. Nissen added.

“I am pleased that the ACC has articulated the value of a balanced approach to career and family.”

Dr. Walsh, Dr. Krumholz, and Dr. Nissen report no relevant financial relationships.

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

A new statement from the American College of Cardiology is calling for a greater degree of career flexibility in the specialty to promote cardiologists’ personal and professional well-being and preserve excellence in patient care.

The statement recommends that cardiologists, from trainees to those contemplating retirement, be granted more leeway in their careers to allow them to take time for common life events, such as child-rearing, taking care of aged parents, or reducing their workload in case of poor health or physical disabilities, without jeopardizing their careers.

The “2022 ACC Health Policy Statement on Career Flexibility in Cardiology: A Report of the American College of Cardiology Solution Set Oversight Committee” was published online in the Journal of the American College of Cardiology.
 

‘Hard-driving profession’

The well-being of the cardiovascular workforce is critical to the achievement of the mission of the ACC, which is to transform cardiovascular care and improve heart health, the Health Policy writing committee stated. Career flexibility is an important component of ensuring that well-being, the authors wrote.

“The ACC has critically looked at the factors that contribute to the lack of diversity and inclusion in cardiovascular practice, and one of the issues is the lack of flexibility in our profession,” writing committee chair, Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation programs, Ascension St. Vincent Heart Center, Indianapolis, Ind., told this news organization.

The notion of work-life balance has become increasingly important but cardiology as a profession has traditionally not been open to the idea of its value, Dr. Walsh said.

“We have a very hard-driving profession. It takes many years to train to do the work we do. The need for on-call services is very significant, and we go along because we have always done it this way, but if you don’t reexamine the way that you are structuring your work, you’ll never change it,” she said.

“For example, the ‘full time, full call, come to work after you’ve been up all night’ work ethic, which is no longer allowed for trainees, is still in effect once you get into university practice or clinical practice. We have interventional cardiologists up all night doing STEMI care for patients and then having a full clinic the next day,” Dr. Walsh said. “The changes that came about for trainees have not trickled up to the faculty or clinical practice level. It’s really a patient safety issue.”

She emphasized that the new policy statement is not focused solely on women. “The need for time away or flexible time around family planning, childbirth, and parental leave is increasingly important to our younger colleagues, both men and women.”

Dr. Walsh pointed out that the writing committee was carefully composed to include representation from all stakeholders.

“We have representation from very young cardiologists, one of whom was in training at the time we began our work. We have two systems CEOs who are cardiologists, we have a chair of medicine, we have two very senior cardiologists, and someone who works in industry,” she said.

The ACC also believes that cardiologists with physically demanding roles should have pathways to transition into other opportunities in patient care, research, or education.

“Right now, there are many cardiology practices that have traditional policies, where you are either all in, or you are all out. They do not allow for what we term a ‘step down’ policy, where you perhaps stop going into the cath lab, but you still do clinic and see patients,” Dr. Walsh noted.

“One of the goals of this policy statement is to allow for such practices to look at their compensation and structure, and to realize that their most senior cardiologists may be willing to stay on for several more years and be contributing members to the practice, but they may no longer wish to stay in the cath lab or be in the night call pool,” she said.

Transparency around compensation is also very important because cardiologists contemplating a reduced work schedule need to know how this will affect the amount of money they will be earning, she added.

“Transparency about policies around compensation are crucial because if an individual cardiologist wishes to pursue a flexible scheduling at any time in their career, it’s clear that they won’t have the same compensation as someone who is a full-time employee. All of this has to be very transparent and clear on both sides, so that the person deciding toward some flexibility understands what the implications are from a financial and compensation standpoint,” Dr. Walsh said.

As an example, a senior career cardiologist who no longer wants to take night calls should know what this may cost financially.

“The practice should set a valuation of night calls, so that the individual who makes the choice to step out of the call pool understands what the impact on their compensation will be. That type of transparency is necessary for all to ensure that individuals who seek flexibility will not be blindsided by the resulting decrease in financial compensation,” she said.
 

A growing need

“In its new health policy statement, the American College of Cardiology addresses the growing need for career flexibility as an important component of ensuring the well-being of the cardiovascular care workforce,” Harlan M. Krumholz, MD, SM, Harold H. Hines Jr. Professor of Medicine and professor in the Institute for Social and Policy Studies at Yale University, New Haven, Conn., told this news organization.

Courtesy Yale University

“The writing committee reviews opportunities for offering flexibility at all career levels to combat burnout and increase retention in the field, as well as proposes system, policy, and practice solutions to allow both men and women to emphasize and embrace work-life balance,” Dr. Krumholz said.

“The document provides pathways for cardiologists looking to pursue other interests or career transitions while maintaining excellence in clinical care,” he added. “Chief among these recommendations are flexible/part-time hours, leave and reentry policies, changes in job descriptions to support overarching cultural change, and equitable compensation and opportunities. The document is intended to be used as a guide for innovation in the cardiology workforce.”
 

‘Thoughtful and long overdue’

“This policy statement is thoughtful and long overdue,” Steven E. Nissen, MD, Lewis and Patricia Dickey Chair in Cardiovascular Medicine and professor of medicine at Cleveland Clinic, told this news organization.

“Career flexibility will allow cardiologists to fulfill family responsibilities while continuing to advance their careers. Successfully contributing to patient care and research does not require physicians to isolate themselves from all their other responsibilities,” Dr. Nissen added.

“I am pleased that the ACC has articulated the value of a balanced approach to career and family.”

Dr. Walsh, Dr. Krumholz, and Dr. Nissen report no relevant financial relationships.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.  

“Automated insulin delivery systems” is becoming the standard terminology – including by the U.S. Food and Drug Administration – to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. “Hybrid AID” or “hybrid closed-loop” refers to the current status of these systems, which still require some degree of user input to control glucose levels.

The term “artificial pancreas” was used interchangeably with AID in the past, but it doesn’t take into account exocrine pancreatic function. The term “bionic pancreas” refers to a specific system in development that would ultimately include glucagon along with insulin.

The new consensus report, titled “Automated insulin delivery: Benefits, challenges, and recommendations,” was published online in Diabetes Care and Diabetologia.  

The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dietitians. Colleagues working at regulatory agencies, health care organizations, and related media might also benefit from reading it.

It is endorsed by two professional societies – the European Association for the Study of Diabetes and the American Diabetes Association – and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, England, in a statement.

“Many clinically relevant aspects, including safety, are addressed in this report. The aim ... is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it,” Dr. Evans said.

Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Conn., commented that the report “addresses the clinical usage of AID systems from a practical point of view rather than as ... a meta-analysis or a review of all relevant clinical studies. ... As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
 

AID systems do not mean diabetes is “cured”

Separate recommendations provided at the end of the document are aimed at specific stakeholders, including health care providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.  

The authors make clear in the introduction that, while representing “a significant movement toward optimizing glucose management for individuals with diabetes,” the use of AID systems doesn’t mean that diabetes is “cured.” Rather, “expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.”

In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.

“When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care,” the authors write.

The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.

“Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (that is, nonautomated subcutaneous insulin delivery by pump or injections) in case the AID system fails. They should be able to independently troubleshoot and have access to their health care provider if needed.”

To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.

Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.

Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
 

Recommendations for health care professionals

A table near the end of the document provides specific recommendations for health care professionals, including the following:

• Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with patients with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number or method by which a person with diabetes can always access support from a health care provider at the practice, including weekends and nights.
• Implement, potentially, protocols on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Dr. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Dr. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Dr. Evans from the National Health Service.

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

A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.  

“Automated insulin delivery systems” is becoming the standard terminology – including by the U.S. Food and Drug Administration – to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. “Hybrid AID” or “hybrid closed-loop” refers to the current status of these systems, which still require some degree of user input to control glucose levels.

The term “artificial pancreas” was used interchangeably with AID in the past, but it doesn’t take into account exocrine pancreatic function. The term “bionic pancreas” refers to a specific system in development that would ultimately include glucagon along with insulin.

The new consensus report, titled “Automated insulin delivery: Benefits, challenges, and recommendations,” was published online in Diabetes Care and Diabetologia.  

The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dietitians. Colleagues working at regulatory agencies, health care organizations, and related media might also benefit from reading it.

It is endorsed by two professional societies – the European Association for the Study of Diabetes and the American Diabetes Association – and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, England, in a statement.

“Many clinically relevant aspects, including safety, are addressed in this report. The aim ... is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it,” Dr. Evans said.

Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Conn., commented that the report “addresses the clinical usage of AID systems from a practical point of view rather than as ... a meta-analysis or a review of all relevant clinical studies. ... As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
 

AID systems do not mean diabetes is “cured”

Separate recommendations provided at the end of the document are aimed at specific stakeholders, including health care providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.  

The authors make clear in the introduction that, while representing “a significant movement toward optimizing glucose management for individuals with diabetes,” the use of AID systems doesn’t mean that diabetes is “cured.” Rather, “expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.”

In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.

“When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care,” the authors write.

The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.

“Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (that is, nonautomated subcutaneous insulin delivery by pump or injections) in case the AID system fails. They should be able to independently troubleshoot and have access to their health care provider if needed.”

To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.

Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.

Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
 

Recommendations for health care professionals

A table near the end of the document provides specific recommendations for health care professionals, including the following:

• Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with patients with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number or method by which a person with diabetes can always access support from a health care provider at the practice, including weekends and nights.
• Implement, potentially, protocols on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Dr. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Dr. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Dr. Evans from the National Health Service.

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

A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.  

“Automated insulin delivery systems” is becoming the standard terminology – including by the U.S. Food and Drug Administration – to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. “Hybrid AID” or “hybrid closed-loop” refers to the current status of these systems, which still require some degree of user input to control glucose levels.

The term “artificial pancreas” was used interchangeably with AID in the past, but it doesn’t take into account exocrine pancreatic function. The term “bionic pancreas” refers to a specific system in development that would ultimately include glucagon along with insulin.

The new consensus report, titled “Automated insulin delivery: Benefits, challenges, and recommendations,” was published online in Diabetes Care and Diabetologia.  

The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dietitians. Colleagues working at regulatory agencies, health care organizations, and related media might also benefit from reading it.

It is endorsed by two professional societies – the European Association for the Study of Diabetes and the American Diabetes Association – and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, England, in a statement.

“Many clinically relevant aspects, including safety, are addressed in this report. The aim ... is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it,” Dr. Evans said.

Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Conn., commented that the report “addresses the clinical usage of AID systems from a practical point of view rather than as ... a meta-analysis or a review of all relevant clinical studies. ... As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
 

AID systems do not mean diabetes is “cured”

Separate recommendations provided at the end of the document are aimed at specific stakeholders, including health care providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.  

The authors make clear in the introduction that, while representing “a significant movement toward optimizing glucose management for individuals with diabetes,” the use of AID systems doesn’t mean that diabetes is “cured.” Rather, “expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.”

In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.

“When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care,” the authors write.

The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.

“Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (that is, nonautomated subcutaneous insulin delivery by pump or injections) in case the AID system fails. They should be able to independently troubleshoot and have access to their health care provider if needed.”

To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.

Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.

Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
 

Recommendations for health care professionals

A table near the end of the document provides specific recommendations for health care professionals, including the following:

• Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with patients with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number or method by which a person with diabetes can always access support from a health care provider at the practice, including weekends and nights.
• Implement, potentially, protocols on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Dr. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Dr. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Dr. Evans from the National Health Service.

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

Physician authors of clinical practice guidelines for psoriatic arthritis in the United States and Japan received payments from pharmaceutical companies totaling over $7 million during 2016-2018, according to a retrospective analysis of all authors on the most recent guidelines issued by the American College of Rheumatology (ACR) and the Japanese Dermatological Association (JDA).

In addition to finding that the majority of the authors of psoriatic arthritis (PsA) clinical practice guidelines (CPGs) issued by the JDA and ACR received substantial personal payments from pharmaceutical companies before and during CPG development, researchers led by Hanano Mamada and Anju Murayama of the Medical Governance Research Institute, Tokyo, wrote in Arthritis Care & Research that “several CPG authors self-cited their articles without the disclosure of NFCOI [nonfinancial conflicts of interest], and most of the recommendations were based on low or very low quality of evidence. Although the COI policies used by JDA and ACR are clearly inadequate, no significant revisions have been made for the last 3 years.”

Based on their findings, which were made using payment data from major Japanese pharmaceutical companies and the U.S. Open Payments Database from 2016 to 2018, the researchers suggested that the medical societies should:

• Adopt global standard COI policies from organizations such as the National Academy of Medicine and Guidelines International Network, including a 3-year lookback period for COI declaration.
• Consider a comprehensive definition and rigorous management with full disclosure of NFCOI.
• Publish a list of authors making each recommendation to grasp the implications of COI in clinical practice guidelines.
• Mention the detailed date of the COI disclosure, which should be close to the publication date as much as possible.

Financial conflicts of interest

The researchers used payment data published between 2016 and 2018 for all 83 companies belonging to the Japan Pharmaceutical Manufacturers Association, focusing on personal payments (for lecturing, writing, and consultancy) and excluding research payments, “since in Japan, the name, institution, and position of the author or researcher who received the research payment is not disclosed, which makes assessing research payments difficult.” To evaluate authors’ FCOI in the ACR’s CPG, the researchers analyzed the U.S. Open Payments Database “for all categories of general payments such as speaking, consulting, meals, and travel expenses 3 years from before the guideline’s first online publication on November 30, 2018.”

The 2018 ACR/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis had 36 authors and the JDA’s Clinical Practice Guideline for the Treatment of Psoriatic Arthritis 2019 had 23. Overall, 61% of JDA authors and half of ACR authors voluntarily declared FCOI with pharmaceutical companies; 25 of the ACR authors were U.S. physicians and could be included in the Open Payments Database search.

A total of 21 (91.3%) JDA authors and 21 (84.0%) ACR authors received at least one payment, with the combined total of $3,335,413 and $4,081,629 payments, respectively, over the 3 years. The average and median personal payments were $145,018 and $123,876 for JDA authors and $162,825 and $58,826 for ACR authors. When the payments to ACR authors were limited to lecturing, writing, and consulting fees that are required under the ACR’s COI policy, the mean was $130,102 and median was $39,375. The corresponding payments for JDA authors were $123,876 and $8,170, respectively,

The researchers found undisclosed payments for more than three-quarters of physician authors of the Japanese guideline, and nearly half of the doctors authoring the American guideline had undisclosed payments. These added up to $474,000 for the JDA, which amounted to 38% of the total for personal payments that must be reported to the JDA based on its COI policy for clinical practice guidelines, and $218,000 for the ACR, amounting to 18% of the total for personal payments that must be reported to the society based on its COI policy.

Of the 11 ACR authors who were not eligible for the U.S. Open Payments Database search, 5 declared FCOI with pharmaceutical companies in the guideline, meaning that 26 (72%) of the 36 authors had FCOI with pharmaceutical companies.

The ACR only required authors to declare FCOI covering 1 year before and during guideline development, and although the JDA required authors to declare their FCOI for the past 3 years of guideline development, the study authors noted that the JDA guideline disclosed them for only 2 years (between Jan. 1, 2017, and Dec. 31, 2018).

“It is true that influential doctors such as clinical practice guideline authors tend to receive various types of payments from pharmaceutical companies and that it is difficult to conduct research without funding from pharmaceutical companies. However, our current research mainly focuses on personal payments from pharmaceutical companies such as lecture fees and consulting fees. These payments are recognized as pocket money and are not used for research. Thus, it is questionable that the observed relationships are something evitable,” the researchers wrote.
 

Nonfinancial conflicts of interest

Many authors of the ACR’s CPG and the JDA’s CPG also had NFCOI, defined objectively in this study as self-citation rate. NFCOI have been more broadly defined by the International Committee of Medical Journal Editors (ICMJE) as “conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs”; the ICMJE recommends reporting NFCOI on its COI form.

The JDA guideline included self-citations by 78% of its authors, compared with 32% of the ACR guideline authors, but this weighed differently among the two guidelines in that only 12 of the 354 (3.4%) citations in the JDA guideline were self-cited, compared with 46 of 137 (34%) citations in the ACR guideline.

The researchers noted that while the self-citation rates between JDA and ACR authors “differed remarkably,” the impact of ACR authors on CPG recommendations was much more direct. Three-quarters of JDA authors’ self-cited articles were about observational studies, whereas 52% of the ACR authors’ self-cited articles were clinical trials, most of which were randomized, controlled studies, and these NFCOI were not disclosed in the guideline.

Half of the strong recommendations in the JDA guideline were based on low or very low quality of evidence, whereas the ACR guideline had no strong recommendations based on low or very low quality of evidence.

This study was supported by the nonprofit Medical Governance Research Institute, which receives donations from Ain Pharmacies Inc., other organizations, and private individuals. The study also received support from the Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. Three authors reported receiving personal fees from several pharmaceutical companies for work outside of the scope of this study.

Physician authors of clinical practice guidelines for psoriatic arthritis in the United States and Japan received payments from pharmaceutical companies totaling over $7 million during 2016-2018, according to a retrospective analysis of all authors on the most recent guidelines issued by the American College of Rheumatology (ACR) and the Japanese Dermatological Association (JDA).

In addition to finding that the majority of the authors of psoriatic arthritis (PsA) clinical practice guidelines (CPGs) issued by the JDA and ACR received substantial personal payments from pharmaceutical companies before and during CPG development, researchers led by Hanano Mamada and Anju Murayama of the Medical Governance Research Institute, Tokyo, wrote in Arthritis Care & Research that “several CPG authors self-cited their articles without the disclosure of NFCOI [nonfinancial conflicts of interest], and most of the recommendations were based on low or very low quality of evidence. Although the COI policies used by JDA and ACR are clearly inadequate, no significant revisions have been made for the last 3 years.”

Based on their findings, which were made using payment data from major Japanese pharmaceutical companies and the U.S. Open Payments Database from 2016 to 2018, the researchers suggested that the medical societies should:

• Adopt global standard COI policies from organizations such as the National Academy of Medicine and Guidelines International Network, including a 3-year lookback period for COI declaration.
• Consider a comprehensive definition and rigorous management with full disclosure of NFCOI.
• Publish a list of authors making each recommendation to grasp the implications of COI in clinical practice guidelines.
• Mention the detailed date of the COI disclosure, which should be close to the publication date as much as possible.

Financial conflicts of interest

The researchers used payment data published between 2016 and 2018 for all 83 companies belonging to the Japan Pharmaceutical Manufacturers Association, focusing on personal payments (for lecturing, writing, and consultancy) and excluding research payments, “since in Japan, the name, institution, and position of the author or researcher who received the research payment is not disclosed, which makes assessing research payments difficult.” To evaluate authors’ FCOI in the ACR’s CPG, the researchers analyzed the U.S. Open Payments Database “for all categories of general payments such as speaking, consulting, meals, and travel expenses 3 years from before the guideline’s first online publication on November 30, 2018.”

The 2018 ACR/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis had 36 authors and the JDA’s Clinical Practice Guideline for the Treatment of Psoriatic Arthritis 2019 had 23. Overall, 61% of JDA authors and half of ACR authors voluntarily declared FCOI with pharmaceutical companies; 25 of the ACR authors were U.S. physicians and could be included in the Open Payments Database search.

A total of 21 (91.3%) JDA authors and 21 (84.0%) ACR authors received at least one payment, with the combined total of $3,335,413 and $4,081,629 payments, respectively, over the 3 years. The average and median personal payments were $145,018 and $123,876 for JDA authors and $162,825 and $58,826 for ACR authors. When the payments to ACR authors were limited to lecturing, writing, and consulting fees that are required under the ACR’s COI policy, the mean was $130,102 and median was $39,375. The corresponding payments for JDA authors were $123,876 and $8,170, respectively,

The researchers found undisclosed payments for more than three-quarters of physician authors of the Japanese guideline, and nearly half of the doctors authoring the American guideline had undisclosed payments. These added up to $474,000 for the JDA, which amounted to 38% of the total for personal payments that must be reported to the JDA based on its COI policy for clinical practice guidelines, and $218,000 for the ACR, amounting to 18% of the total for personal payments that must be reported to the society based on its COI policy.

Of the 11 ACR authors who were not eligible for the U.S. Open Payments Database search, 5 declared FCOI with pharmaceutical companies in the guideline, meaning that 26 (72%) of the 36 authors had FCOI with pharmaceutical companies.

The ACR only required authors to declare FCOI covering 1 year before and during guideline development, and although the JDA required authors to declare their FCOI for the past 3 years of guideline development, the study authors noted that the JDA guideline disclosed them for only 2 years (between Jan. 1, 2017, and Dec. 31, 2018).

“It is true that influential doctors such as clinical practice guideline authors tend to receive various types of payments from pharmaceutical companies and that it is difficult to conduct research without funding from pharmaceutical companies. However, our current research mainly focuses on personal payments from pharmaceutical companies such as lecture fees and consulting fees. These payments are recognized as pocket money and are not used for research. Thus, it is questionable that the observed relationships are something evitable,” the researchers wrote.
 

Nonfinancial conflicts of interest

Many authors of the ACR’s CPG and the JDA’s CPG also had NFCOI, defined objectively in this study as self-citation rate. NFCOI have been more broadly defined by the International Committee of Medical Journal Editors (ICMJE) as “conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs”; the ICMJE recommends reporting NFCOI on its COI form.

The JDA guideline included self-citations by 78% of its authors, compared with 32% of the ACR guideline authors, but this weighed differently among the two guidelines in that only 12 of the 354 (3.4%) citations in the JDA guideline were self-cited, compared with 46 of 137 (34%) citations in the ACR guideline.

The researchers noted that while the self-citation rates between JDA and ACR authors “differed remarkably,” the impact of ACR authors on CPG recommendations was much more direct. Three-quarters of JDA authors’ self-cited articles were about observational studies, whereas 52% of the ACR authors’ self-cited articles were clinical trials, most of which were randomized, controlled studies, and these NFCOI were not disclosed in the guideline.

Half of the strong recommendations in the JDA guideline were based on low or very low quality of evidence, whereas the ACR guideline had no strong recommendations based on low or very low quality of evidence.

This study was supported by the nonprofit Medical Governance Research Institute, which receives donations from Ain Pharmacies Inc., other organizations, and private individuals. The study also received support from the Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. Three authors reported receiving personal fees from several pharmaceutical companies for work outside of the scope of this study.

Physician authors of clinical practice guidelines for psoriatic arthritis in the United States and Japan received payments from pharmaceutical companies totaling over $7 million during 2016-2018, according to a retrospective analysis of all authors on the most recent guidelines issued by the American College of Rheumatology (ACR) and the Japanese Dermatological Association (JDA).

In addition to finding that the majority of the authors of psoriatic arthritis (PsA) clinical practice guidelines (CPGs) issued by the JDA and ACR received substantial personal payments from pharmaceutical companies before and during CPG development, researchers led by Hanano Mamada and Anju Murayama of the Medical Governance Research Institute, Tokyo, wrote in Arthritis Care & Research that “several CPG authors self-cited their articles without the disclosure of NFCOI [nonfinancial conflicts of interest], and most of the recommendations were based on low or very low quality of evidence. Although the COI policies used by JDA and ACR are clearly inadequate, no significant revisions have been made for the last 3 years.”

Based on their findings, which were made using payment data from major Japanese pharmaceutical companies and the U.S. Open Payments Database from 2016 to 2018, the researchers suggested that the medical societies should:

• Adopt global standard COI policies from organizations such as the National Academy of Medicine and Guidelines International Network, including a 3-year lookback period for COI declaration.
• Consider a comprehensive definition and rigorous management with full disclosure of NFCOI.
• Publish a list of authors making each recommendation to grasp the implications of COI in clinical practice guidelines.
• Mention the detailed date of the COI disclosure, which should be close to the publication date as much as possible.

Financial conflicts of interest

The researchers used payment data published between 2016 and 2018 for all 83 companies belonging to the Japan Pharmaceutical Manufacturers Association, focusing on personal payments (for lecturing, writing, and consultancy) and excluding research payments, “since in Japan, the name, institution, and position of the author or researcher who received the research payment is not disclosed, which makes assessing research payments difficult.” To evaluate authors’ FCOI in the ACR’s CPG, the researchers analyzed the U.S. Open Payments Database “for all categories of general payments such as speaking, consulting, meals, and travel expenses 3 years from before the guideline’s first online publication on November 30, 2018.”

The 2018 ACR/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis had 36 authors and the JDA’s Clinical Practice Guideline for the Treatment of Psoriatic Arthritis 2019 had 23. Overall, 61% of JDA authors and half of ACR authors voluntarily declared FCOI with pharmaceutical companies; 25 of the ACR authors were U.S. physicians and could be included in the Open Payments Database search.

A total of 21 (91.3%) JDA authors and 21 (84.0%) ACR authors received at least one payment, with the combined total of $3,335,413 and $4,081,629 payments, respectively, over the 3 years. The average and median personal payments were $145,018 and $123,876 for JDA authors and $162,825 and $58,826 for ACR authors. When the payments to ACR authors were limited to lecturing, writing, and consulting fees that are required under the ACR’s COI policy, the mean was $130,102 and median was $39,375. The corresponding payments for JDA authors were $123,876 and $8,170, respectively,

The researchers found undisclosed payments for more than three-quarters of physician authors of the Japanese guideline, and nearly half of the doctors authoring the American guideline had undisclosed payments. These added up to $474,000 for the JDA, which amounted to 38% of the total for personal payments that must be reported to the JDA based on its COI policy for clinical practice guidelines, and $218,000 for the ACR, amounting to 18% of the total for personal payments that must be reported to the society based on its COI policy.

Of the 11 ACR authors who were not eligible for the U.S. Open Payments Database search, 5 declared FCOI with pharmaceutical companies in the guideline, meaning that 26 (72%) of the 36 authors had FCOI with pharmaceutical companies.

The ACR only required authors to declare FCOI covering 1 year before and during guideline development, and although the JDA required authors to declare their FCOI for the past 3 years of guideline development, the study authors noted that the JDA guideline disclosed them for only 2 years (between Jan. 1, 2017, and Dec. 31, 2018).

“It is true that influential doctors such as clinical practice guideline authors tend to receive various types of payments from pharmaceutical companies and that it is difficult to conduct research without funding from pharmaceutical companies. However, our current research mainly focuses on personal payments from pharmaceutical companies such as lecture fees and consulting fees. These payments are recognized as pocket money and are not used for research. Thus, it is questionable that the observed relationships are something evitable,” the researchers wrote.
 

Nonfinancial conflicts of interest

Many authors of the ACR’s CPG and the JDA’s CPG also had NFCOI, defined objectively in this study as self-citation rate. NFCOI have been more broadly defined by the International Committee of Medical Journal Editors (ICMJE) as “conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs”; the ICMJE recommends reporting NFCOI on its COI form.

The JDA guideline included self-citations by 78% of its authors, compared with 32% of the ACR guideline authors, but this weighed differently among the two guidelines in that only 12 of the 354 (3.4%) citations in the JDA guideline were self-cited, compared with 46 of 137 (34%) citations in the ACR guideline.

The researchers noted that while the self-citation rates between JDA and ACR authors “differed remarkably,” the impact of ACR authors on CPG recommendations was much more direct. Three-quarters of JDA authors’ self-cited articles were about observational studies, whereas 52% of the ACR authors’ self-cited articles were clinical trials, most of which were randomized, controlled studies, and these NFCOI were not disclosed in the guideline.

Half of the strong recommendations in the JDA guideline were based on low or very low quality of evidence, whereas the ACR guideline had no strong recommendations based on low or very low quality of evidence.

This study was supported by the nonprofit Medical Governance Research Institute, which receives donations from Ain Pharmacies Inc., other organizations, and private individuals. The study also received support from the Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. Three authors reported receiving personal fees from several pharmaceutical companies for work outside of the scope of this study.

The proper management of subepithelial lesions (SELs) depends on the size, histopathology, malignant potential, and presence of symptoms, according to a new American Gastroenterological Association clinical practice update published in Clinical Gastroenterology and Hepatology.

“SELs are found in 1 in every 300 endoscopies, and two-thirds of these lesions are located in the stomach,” explained Kaveh Sharzehi, MD, an associate professor of medicine in the division of gastroenterology and hepatology at Oregon Health & Science University, Portland, and colleagues. “They represent a heterogeneous group of lesions including nonneoplastic lesions such as ectopic pancreatic tissue and neoplastic lesions. The neoplastic SELs can vary from lesions with no malignant potential such as lipomas to those with malignant potential such as gastrointestinal stromal tumors (GISTs). The majority of SELs are small and found incidentally.”

The authors developed 10 clinical practice advice statements on the diagnosis and management of subepithelial lesions based on a review of the published literature and expert opinion.

First, standard mucosal biopsies often don’t reach deep enough to obtain a pathologic diagnosis for SELs because the lesions have normal overlying mucosa. Forceps bite-on-bite/deep-well biopsies or tunnel biopsies may help to establish a pathologic diagnosis.

Used as an adjunct to standard endoscopy, endoscopic ultrasound (EUS) has become the primary method for determining diagnostic and prognostic characteristics of SELs – such as the layer of origin, echogenicity, and presence of blood vessels within the lesion. It can also help with tissue acquisition.

For SELs arising from the submucosa, EUS-guided fine-needle aspiration and fine-needle biopsy have evolved as widely used methods for obtaining tissue. For SELs arising from muscularis propria, fine-needle aspiration and fine-needle biopsy should be used to determine whether the lesion is a GIST or leiomyoma. Using structural assessment and staining will allow for the differentiation of mesenchymal tumors and assessment of their malignant potential.

To remove SELs, multiple endoscopic resection techniques may be appropriate, depending on the layer of origin, size, and location, with the goal of complete, en bloc resection with no disruption to the wall or capsule of the lesion. These techniques should be limited to endoscopists skilled in advanced tissue resection.

SELs without malignant potential, such as lipoma or pancreatic rest, don’t need further evaluation or surveillance.

SELs that are ulcerated, bleeding, or causing symptoms should be considered for resection.

Other lesions are managed with resection or surveillance based on pathology. For example, leiomyomas, which are benign and most often found in the esophagus, generally don’t require surveillance or resection. On the other hand, all GISTs have some malignant potential, and management varies by size, location, and presence of symptoms. GISTs larger than 2 cm, should be considered for resection. Some GISTs between 2 cm and 4 cm without high-risk features can be removed by using advanced endoscopic resection techniques.

The determination for resection in all cases should include a multidisciplinary approach, with confirmation of a low mitotic index and lack of metastatic disease on cross-sectional imaging.

“The ultimate goal of endoscopic resection is to have a complete resection,” the authors wrote. “Determining the layer of involvement by EUS is critical in planning resection techniques.”

The authors reported no grant support or funding sources for this report. One author serves as a consultant for Boston Scientific, Fujifilm, Intuitive Surgical, Medtronic, and Olympus. The remaining authors disclosed no conflicts.

The proper management of subepithelial lesions (SELs) depends on the size, histopathology, malignant potential, and presence of symptoms, according to a new American Gastroenterological Association clinical practice update published in Clinical Gastroenterology and Hepatology.

“SELs are found in 1 in every 300 endoscopies, and two-thirds of these lesions are located in the stomach,” explained Kaveh Sharzehi, MD, an associate professor of medicine in the division of gastroenterology and hepatology at Oregon Health & Science University, Portland, and colleagues. “They represent a heterogeneous group of lesions including nonneoplastic lesions such as ectopic pancreatic tissue and neoplastic lesions. The neoplastic SELs can vary from lesions with no malignant potential such as lipomas to those with malignant potential such as gastrointestinal stromal tumors (GISTs). The majority of SELs are small and found incidentally.”

The authors developed 10 clinical practice advice statements on the diagnosis and management of subepithelial lesions based on a review of the published literature and expert opinion.

First, standard mucosal biopsies often don’t reach deep enough to obtain a pathologic diagnosis for SELs because the lesions have normal overlying mucosa. Forceps bite-on-bite/deep-well biopsies or tunnel biopsies may help to establish a pathologic diagnosis.

Used as an adjunct to standard endoscopy, endoscopic ultrasound (EUS) has become the primary method for determining diagnostic and prognostic characteristics of SELs – such as the layer of origin, echogenicity, and presence of blood vessels within the lesion. It can also help with tissue acquisition.

For SELs arising from the submucosa, EUS-guided fine-needle aspiration and fine-needle biopsy have evolved as widely used methods for obtaining tissue. For SELs arising from muscularis propria, fine-needle aspiration and fine-needle biopsy should be used to determine whether the lesion is a GIST or leiomyoma. Using structural assessment and staining will allow for the differentiation of mesenchymal tumors and assessment of their malignant potential.

To remove SELs, multiple endoscopic resection techniques may be appropriate, depending on the layer of origin, size, and location, with the goal of complete, en bloc resection with no disruption to the wall or capsule of the lesion. These techniques should be limited to endoscopists skilled in advanced tissue resection.

SELs without malignant potential, such as lipoma or pancreatic rest, don’t need further evaluation or surveillance.

SELs that are ulcerated, bleeding, or causing symptoms should be considered for resection.

Other lesions are managed with resection or surveillance based on pathology. For example, leiomyomas, which are benign and most often found in the esophagus, generally don’t require surveillance or resection. On the other hand, all GISTs have some malignant potential, and management varies by size, location, and presence of symptoms. GISTs larger than 2 cm, should be considered for resection. Some GISTs between 2 cm and 4 cm without high-risk features can be removed by using advanced endoscopic resection techniques.

The determination for resection in all cases should include a multidisciplinary approach, with confirmation of a low mitotic index and lack of metastatic disease on cross-sectional imaging.

“The ultimate goal of endoscopic resection is to have a complete resection,” the authors wrote. “Determining the layer of involvement by EUS is critical in planning resection techniques.”

The authors reported no grant support or funding sources for this report. One author serves as a consultant for Boston Scientific, Fujifilm, Intuitive Surgical, Medtronic, and Olympus. The remaining authors disclosed no conflicts.

The proper management of subepithelial lesions (SELs) depends on the size, histopathology, malignant potential, and presence of symptoms, according to a new American Gastroenterological Association clinical practice update published in Clinical Gastroenterology and Hepatology.

“SELs are found in 1 in every 300 endoscopies, and two-thirds of these lesions are located in the stomach,” explained Kaveh Sharzehi, MD, an associate professor of medicine in the division of gastroenterology and hepatology at Oregon Health & Science University, Portland, and colleagues. “They represent a heterogeneous group of lesions including nonneoplastic lesions such as ectopic pancreatic tissue and neoplastic lesions. The neoplastic SELs can vary from lesions with no malignant potential such as lipomas to those with malignant potential such as gastrointestinal stromal tumors (GISTs). The majority of SELs are small and found incidentally.”

The authors developed 10 clinical practice advice statements on the diagnosis and management of subepithelial lesions based on a review of the published literature and expert opinion.

First, standard mucosal biopsies often don’t reach deep enough to obtain a pathologic diagnosis for SELs because the lesions have normal overlying mucosa. Forceps bite-on-bite/deep-well biopsies or tunnel biopsies may help to establish a pathologic diagnosis.

Used as an adjunct to standard endoscopy, endoscopic ultrasound (EUS) has become the primary method for determining diagnostic and prognostic characteristics of SELs – such as the layer of origin, echogenicity, and presence of blood vessels within the lesion. It can also help with tissue acquisition.

For SELs arising from the submucosa, EUS-guided fine-needle aspiration and fine-needle biopsy have evolved as widely used methods for obtaining tissue. For SELs arising from muscularis propria, fine-needle aspiration and fine-needle biopsy should be used to determine whether the lesion is a GIST or leiomyoma. Using structural assessment and staining will allow for the differentiation of mesenchymal tumors and assessment of their malignant potential.

To remove SELs, multiple endoscopic resection techniques may be appropriate, depending on the layer of origin, size, and location, with the goal of complete, en bloc resection with no disruption to the wall or capsule of the lesion. These techniques should be limited to endoscopists skilled in advanced tissue resection.

SELs without malignant potential, such as lipoma or pancreatic rest, don’t need further evaluation or surveillance.

SELs that are ulcerated, bleeding, or causing symptoms should be considered for resection.

Other lesions are managed with resection or surveillance based on pathology. For example, leiomyomas, which are benign and most often found in the esophagus, generally don’t require surveillance or resection. On the other hand, all GISTs have some malignant potential, and management varies by size, location, and presence of symptoms. GISTs larger than 2 cm, should be considered for resection. Some GISTs between 2 cm and 4 cm without high-risk features can be removed by using advanced endoscopic resection techniques.

The determination for resection in all cases should include a multidisciplinary approach, with confirmation of a low mitotic index and lack of metastatic disease on cross-sectional imaging.

“The ultimate goal of endoscopic resection is to have a complete resection,” the authors wrote. “Determining the layer of involvement by EUS is critical in planning resection techniques.”

The authors reported no grant support or funding sources for this report. One author serves as a consultant for Boston Scientific, Fujifilm, Intuitive Surgical, Medtronic, and Olympus. The remaining authors disclosed no conflicts.

The American Academy of Pediatrics says children with head lice don’t need to be sent home from school.

Head lice infestations aren’t really a health hazard because of low transmission rates, a new report from the academy says, and sending students home “may stigmatize children suspected of having head lice.” The group says schools should instead offer education programs to help families understand how to manage head lice.

“Head lice are an unpleasant part of the human experience, but they can be successfully managed and are no reason for a child to miss school,” Dawn Nolt, MD, lead author of the report on head lice, said in a news release.

The report advises schools to abandon “no-nit” policies, which call for a student to be lice-free before being allowed back in class.

“A child or adolescent should not be restricted from school attendance because of head lice, given the low contagion within classrooms. ‘No-nit’ policies that exclude children or adolescents until all nits are removed may violate a child’s or adolescent’s civil liberties and are best addressed with legal counsel for schools,” the report says.

The report notes that lice almost always spread through head-to-head contact, not by “jumping” from one person to another. It’s possible for lice to spread by touching the belongings of a person with lice, such as combs or sports helmets, but the chances of that happening are very low, the academy said.

“Lice found on combs are likely to be injured or dead, and a louse is not likely to leave a healthy head unless there is a heavy infestation,” the report says.

The report lists new medications for treatment and gives an algorithm for managing head lice cases.

“The ideal treatment of head lice should be safe, free of toxic chemicals, readily available, simple to apply, effective, and inexpensive,” the report says.

This is the first updated guidance on head lice from the American Academy of Pediatrics since 2015. The CDC also says students with head lice don’t need to be sent home.

“Students diagnosed with live head lice do not need to be sent home early from school; they can go home at the end of the day, be treated, and return to class after appropriate treatment has begun. Nits may persist after treatment, but successful treatment should kill crawling lice,” the CDC says. 

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

The American Academy of Pediatrics says children with head lice don’t need to be sent home from school.

Head lice infestations aren’t really a health hazard because of low transmission rates, a new report from the academy says, and sending students home “may stigmatize children suspected of having head lice.” The group says schools should instead offer education programs to help families understand how to manage head lice.

“Head lice are an unpleasant part of the human experience, but they can be successfully managed and are no reason for a child to miss school,” Dawn Nolt, MD, lead author of the report on head lice, said in a news release.

The report advises schools to abandon “no-nit” policies, which call for a student to be lice-free before being allowed back in class.

“A child or adolescent should not be restricted from school attendance because of head lice, given the low contagion within classrooms. ‘No-nit’ policies that exclude children or adolescents until all nits are removed may violate a child’s or adolescent’s civil liberties and are best addressed with legal counsel for schools,” the report says.

The report notes that lice almost always spread through head-to-head contact, not by “jumping” from one person to another. It’s possible for lice to spread by touching the belongings of a person with lice, such as combs or sports helmets, but the chances of that happening are very low, the academy said.

“Lice found on combs are likely to be injured or dead, and a louse is not likely to leave a healthy head unless there is a heavy infestation,” the report says.

The report lists new medications for treatment and gives an algorithm for managing head lice cases.

“The ideal treatment of head lice should be safe, free of toxic chemicals, readily available, simple to apply, effective, and inexpensive,” the report says.

This is the first updated guidance on head lice from the American Academy of Pediatrics since 2015. The CDC also says students with head lice don’t need to be sent home.

“Students diagnosed with live head lice do not need to be sent home early from school; they can go home at the end of the day, be treated, and return to class after appropriate treatment has begun. Nits may persist after treatment, but successful treatment should kill crawling lice,” the CDC says. 

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

The American Academy of Pediatrics says children with head lice don’t need to be sent home from school.

Head lice infestations aren’t really a health hazard because of low transmission rates, a new report from the academy says, and sending students home “may stigmatize children suspected of having head lice.” The group says schools should instead offer education programs to help families understand how to manage head lice.

“Head lice are an unpleasant part of the human experience, but they can be successfully managed and are no reason for a child to miss school,” Dawn Nolt, MD, lead author of the report on head lice, said in a news release.

The report advises schools to abandon “no-nit” policies, which call for a student to be lice-free before being allowed back in class.

“A child or adolescent should not be restricted from school attendance because of head lice, given the low contagion within classrooms. ‘No-nit’ policies that exclude children or adolescents until all nits are removed may violate a child’s or adolescent’s civil liberties and are best addressed with legal counsel for schools,” the report says.

The report notes that lice almost always spread through head-to-head contact, not by “jumping” from one person to another. It’s possible for lice to spread by touching the belongings of a person with lice, such as combs or sports helmets, but the chances of that happening are very low, the academy said.

“Lice found on combs are likely to be injured or dead, and a louse is not likely to leave a healthy head unless there is a heavy infestation,” the report says.

The report lists new medications for treatment and gives an algorithm for managing head lice cases.

“The ideal treatment of head lice should be safe, free of toxic chemicals, readily available, simple to apply, effective, and inexpensive,” the report says.

This is the first updated guidance on head lice from the American Academy of Pediatrics since 2015. The CDC also says students with head lice don’t need to be sent home.

“Students diagnosed with live head lice do not need to be sent home early from school; they can go home at the end of the day, be treated, and return to class after appropriate treatment has begun. Nits may persist after treatment, but successful treatment should kill crawling lice,” the CDC says. 

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

The diagnosis and management of refractory celiac disease remains challenging, but ongoing studies can provide the proper diagnostic criteria and identify the optimal management strategies, according to a new American Gastroenterological Association expert review published in Gastroenterology.

Celiac disease is present in about 1% of the U.S. population and can cause various symptoms, wrote Peter H. R. Green, MD, director of the Celiac Disease Center at Columbia University, New York, and colleagues. Adhering to a strict gluten-free diet can improve symptoms, normalize serum antibody levels, and reverse small bowel villous atrophy. However, persistent or recurrent symptoms and elevated celiac antibodies can persist in some patients after a year of trying a gluten-free diet, a condition called nonresponsive celiac disease. In some patients, this raises concern for refractory celiac disease, or RCD.

“RCD is believed to occur in only approximately 1% of patients with celiac disease, although this may be an overestimate, as data are obtained from referral centers,” the authors wrote.

RCD can be classified into two subtypes with different diagnostic criteria, prognoses, and therapy responses. The first, called RCD1, is characterized by villous atrophy but has intraepithelial lymphocytes similar to conventional celiac disease. The other, called RCD2, is characterized by aberrant clonal T-cell expansion in the intestinal tract and other organs, has a poorer prognosis than RCD1, and has a risk of developing ulcerative jejunoileitis or enteropathy-associated T-cell lymphoma.

The experts developed 10 clinical practice advice statements based on a review of the published literature and expert opinion.

First, in patients who have persistent or recurring symptoms, an initial celiac disease diagnosis should be confirmed through review of prior diagnostic testing, including serologies, endoscopies, and histologic findings. Celiac disease can overlap with other gastrointestinal conditions, and some pathologic findings aren’t specific to celiac disease. Results of serologic testing with tissue transglutaminase immunoglobulin A, deamidated gliadin peptide IgA and IgG, and endomysial antibodies should be reviewed or obtained if not previously performed.

Next, in those with confirmed but nonresponsive celiac disease, ongoing gluten ingestion should be excluded as a cause of symptoms with serologic testing, dietitian review, and potentially detection of immunogenic peptides in stool or urine samples. The authors noted that persistent gluten ingestion, whether intentional or inadvertent, accounts for 40%-50% of patients with nonresponsive celiac disease. In these cases, esophagogastroduodenoscopy and small bowel biopsies should be performed to look for persistent villous atrophy, which can also be caused by common variable immunodeficiency, autoimmune enteropathy, tropical sprue, and medication-induced enteropathy. Patients with villous atrophy due to other causes won’t respond to a gluten-free diet.

After excluding gluten, clinicians should perform a systematic evaluation for other potential causes of symptoms, including functional bowel disorders, lactose or fructose intolerance, microscopic colitis, pancreatic insufficiency, inflammatory bowel disease, and small intestinal bacterial growth. Irritable bowel syndrome, for instance, may contribute to persistent symptoms and respond to fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) restriction. RCD should be strongly considered in patients with persistent symptoms or signs of malabsorption after the exclusion of the other causes.

To distinguish between the two subtypes of RCD and exclude enteropathy-associated T-cell lymphoma, clinicians should use flow cytometry, immunohistochemistry, and T-cell receptor rearrangement studies. RCD1 has a normal intraepithelial lymphocyte population, and RCD2 has an aberrant, clonal intraepithelial lymphocyte population. Consulting with a hematopathologist may be necessary to interpret these studies.

After RCD2 is diagnosed, complications such as enteropathy-associated T-cell lymphoma and ulcerative jejunoileitis should be excluded through small bowel imaging with capsule endoscopy and either computed tomography (CT) or magnetic resonance enterography. In general, the extent and severity of villous atrophy is greater in patients with RCD2, compared with RCD1.

In patients diagnosed with RCD, clinicians should complete a detailed nutritional assessment with investigation of micronutrient and macronutrient deficiencies. Check albumin as an independent prognostic factor. Then, try to correct deficiencies with oral supplements. Malnourished patients may need enteral support, and those with severe malnutrition due to malabsorption may need parenteral support.

So far, RCD management suggestions are based on small retrospective studies and expert opinion, with minimal prospective data and no Food and Drug Administration–approved therapies. The goals should be to improve symptoms and duodenal mucosal abnormalities, manage malnutrition, and prevent lymphoma. Glucocorticoids are considered first-line therapy, typically open-capsule budesonide given as 3 mg three times daily. Prednisone serves as an alternative with proven efficacy but a higher risk for adverse effects.

The optimal choice for second-line therapy is unknown, but the addition of an immunosuppressant agent to steroids appears to be effective in RCD1, including azathioprine, mercaptopurine, and tioguanine. The best treatment for RCD2 is unknown, though clinical response has been reported with steroids, and cladribine has been well tolerated in some patients.

Patients with RCD who don’t respond to steroids may benefit from referral to a center with expertise for management or evaluation for inclusion in clinical trials. Frequent medical visits are advised until the disease is well controlled, with regular follow-up after that. 

Ultimately, “patients with RCD benefit from evaluation and regular follow-up by a multidisciplinary team, including gastroenterologists and dietitians, to assess clinical and histologic response to therapy,” the authors wrote. “Identify local experts with expertise in celiac disease to assist with management.”

The authors reported no grant support or funding sources for this study. One author has received research report from Freenome, and another is on the celiac disease advisory board for Takeda. The remaining authors disclosed no conflicts.

The diagnosis and management of refractory celiac disease remains challenging, but ongoing studies can provide the proper diagnostic criteria and identify the optimal management strategies, according to a new American Gastroenterological Association expert review published in Gastroenterology.

Celiac disease is present in about 1% of the U.S. population and can cause various symptoms, wrote Peter H. R. Green, MD, director of the Celiac Disease Center at Columbia University, New York, and colleagues. Adhering to a strict gluten-free diet can improve symptoms, normalize serum antibody levels, and reverse small bowel villous atrophy. However, persistent or recurrent symptoms and elevated celiac antibodies can persist in some patients after a year of trying a gluten-free diet, a condition called nonresponsive celiac disease. In some patients, this raises concern for refractory celiac disease, or RCD.

“RCD is believed to occur in only approximately 1% of patients with celiac disease, although this may be an overestimate, as data are obtained from referral centers,” the authors wrote.

RCD can be classified into two subtypes with different diagnostic criteria, prognoses, and therapy responses. The first, called RCD1, is characterized by villous atrophy but has intraepithelial lymphocytes similar to conventional celiac disease. The other, called RCD2, is characterized by aberrant clonal T-cell expansion in the intestinal tract and other organs, has a poorer prognosis than RCD1, and has a risk of developing ulcerative jejunoileitis or enteropathy-associated T-cell lymphoma.

The experts developed 10 clinical practice advice statements based on a review of the published literature and expert opinion.

First, in patients who have persistent or recurring symptoms, an initial celiac disease diagnosis should be confirmed through review of prior diagnostic testing, including serologies, endoscopies, and histologic findings. Celiac disease can overlap with other gastrointestinal conditions, and some pathologic findings aren’t specific to celiac disease. Results of serologic testing with tissue transglutaminase immunoglobulin A, deamidated gliadin peptide IgA and IgG, and endomysial antibodies should be reviewed or obtained if not previously performed.

Next, in those with confirmed but nonresponsive celiac disease, ongoing gluten ingestion should be excluded as a cause of symptoms with serologic testing, dietitian review, and potentially detection of immunogenic peptides in stool or urine samples. The authors noted that persistent gluten ingestion, whether intentional or inadvertent, accounts for 40%-50% of patients with nonresponsive celiac disease. In these cases, esophagogastroduodenoscopy and small bowel biopsies should be performed to look for persistent villous atrophy, which can also be caused by common variable immunodeficiency, autoimmune enteropathy, tropical sprue, and medication-induced enteropathy. Patients with villous atrophy due to other causes won’t respond to a gluten-free diet.

After excluding gluten, clinicians should perform a systematic evaluation for other potential causes of symptoms, including functional bowel disorders, lactose or fructose intolerance, microscopic colitis, pancreatic insufficiency, inflammatory bowel disease, and small intestinal bacterial growth. Irritable bowel syndrome, for instance, may contribute to persistent symptoms and respond to fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) restriction. RCD should be strongly considered in patients with persistent symptoms or signs of malabsorption after the exclusion of the other causes.

To distinguish between the two subtypes of RCD and exclude enteropathy-associated T-cell lymphoma, clinicians should use flow cytometry, immunohistochemistry, and T-cell receptor rearrangement studies. RCD1 has a normal intraepithelial lymphocyte population, and RCD2 has an aberrant, clonal intraepithelial lymphocyte population. Consulting with a hematopathologist may be necessary to interpret these studies.

After RCD2 is diagnosed, complications such as enteropathy-associated T-cell lymphoma and ulcerative jejunoileitis should be excluded through small bowel imaging with capsule endoscopy and either computed tomography (CT) or magnetic resonance enterography. In general, the extent and severity of villous atrophy is greater in patients with RCD2, compared with RCD1.

In patients diagnosed with RCD, clinicians should complete a detailed nutritional assessment with investigation of micronutrient and macronutrient deficiencies. Check albumin as an independent prognostic factor. Then, try to correct deficiencies with oral supplements. Malnourished patients may need enteral support, and those with severe malnutrition due to malabsorption may need parenteral support.

So far, RCD management suggestions are based on small retrospective studies and expert opinion, with minimal prospective data and no Food and Drug Administration–approved therapies. The goals should be to improve symptoms and duodenal mucosal abnormalities, manage malnutrition, and prevent lymphoma. Glucocorticoids are considered first-line therapy, typically open-capsule budesonide given as 3 mg three times daily. Prednisone serves as an alternative with proven efficacy but a higher risk for adverse effects.

The optimal choice for second-line therapy is unknown, but the addition of an immunosuppressant agent to steroids appears to be effective in RCD1, including azathioprine, mercaptopurine, and tioguanine. The best treatment for RCD2 is unknown, though clinical response has been reported with steroids, and cladribine has been well tolerated in some patients.

Patients with RCD who don’t respond to steroids may benefit from referral to a center with expertise for management or evaluation for inclusion in clinical trials. Frequent medical visits are advised until the disease is well controlled, with regular follow-up after that. 

Ultimately, “patients with RCD benefit from evaluation and regular follow-up by a multidisciplinary team, including gastroenterologists and dietitians, to assess clinical and histologic response to therapy,” the authors wrote. “Identify local experts with expertise in celiac disease to assist with management.”

The authors reported no grant support or funding sources for this study. One author has received research report from Freenome, and another is on the celiac disease advisory board for Takeda. The remaining authors disclosed no conflicts.

The diagnosis and management of refractory celiac disease remains challenging, but ongoing studies can provide the proper diagnostic criteria and identify the optimal management strategies, according to a new American Gastroenterological Association expert review published in Gastroenterology.

Celiac disease is present in about 1% of the U.S. population and can cause various symptoms, wrote Peter H. R. Green, MD, director of the Celiac Disease Center at Columbia University, New York, and colleagues. Adhering to a strict gluten-free diet can improve symptoms, normalize serum antibody levels, and reverse small bowel villous atrophy. However, persistent or recurrent symptoms and elevated celiac antibodies can persist in some patients after a year of trying a gluten-free diet, a condition called nonresponsive celiac disease. In some patients, this raises concern for refractory celiac disease, or RCD.

“RCD is believed to occur in only approximately 1% of patients with celiac disease, although this may be an overestimate, as data are obtained from referral centers,” the authors wrote.

RCD can be classified into two subtypes with different diagnostic criteria, prognoses, and therapy responses. The first, called RCD1, is characterized by villous atrophy but has intraepithelial lymphocytes similar to conventional celiac disease. The other, called RCD2, is characterized by aberrant clonal T-cell expansion in the intestinal tract and other organs, has a poorer prognosis than RCD1, and has a risk of developing ulcerative jejunoileitis or enteropathy-associated T-cell lymphoma.

The experts developed 10 clinical practice advice statements based on a review of the published literature and expert opinion.

First, in patients who have persistent or recurring symptoms, an initial celiac disease diagnosis should be confirmed through review of prior diagnostic testing, including serologies, endoscopies, and histologic findings. Celiac disease can overlap with other gastrointestinal conditions, and some pathologic findings aren’t specific to celiac disease. Results of serologic testing with tissue transglutaminase immunoglobulin A, deamidated gliadin peptide IgA and IgG, and endomysial antibodies should be reviewed or obtained if not previously performed.

Next, in those with confirmed but nonresponsive celiac disease, ongoing gluten ingestion should be excluded as a cause of symptoms with serologic testing, dietitian review, and potentially detection of immunogenic peptides in stool or urine samples. The authors noted that persistent gluten ingestion, whether intentional or inadvertent, accounts for 40%-50% of patients with nonresponsive celiac disease. In these cases, esophagogastroduodenoscopy and small bowel biopsies should be performed to look for persistent villous atrophy, which can also be caused by common variable immunodeficiency, autoimmune enteropathy, tropical sprue, and medication-induced enteropathy. Patients with villous atrophy due to other causes won’t respond to a gluten-free diet.

After excluding gluten, clinicians should perform a systematic evaluation for other potential causes of symptoms, including functional bowel disorders, lactose or fructose intolerance, microscopic colitis, pancreatic insufficiency, inflammatory bowel disease, and small intestinal bacterial growth. Irritable bowel syndrome, for instance, may contribute to persistent symptoms and respond to fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) restriction. RCD should be strongly considered in patients with persistent symptoms or signs of malabsorption after the exclusion of the other causes.

To distinguish between the two subtypes of RCD and exclude enteropathy-associated T-cell lymphoma, clinicians should use flow cytometry, immunohistochemistry, and T-cell receptor rearrangement studies. RCD1 has a normal intraepithelial lymphocyte population, and RCD2 has an aberrant, clonal intraepithelial lymphocyte population. Consulting with a hematopathologist may be necessary to interpret these studies.

After RCD2 is diagnosed, complications such as enteropathy-associated T-cell lymphoma and ulcerative jejunoileitis should be excluded through small bowel imaging with capsule endoscopy and either computed tomography (CT) or magnetic resonance enterography. In general, the extent and severity of villous atrophy is greater in patients with RCD2, compared with RCD1.

In patients diagnosed with RCD, clinicians should complete a detailed nutritional assessment with investigation of micronutrient and macronutrient deficiencies. Check albumin as an independent prognostic factor. Then, try to correct deficiencies with oral supplements. Malnourished patients may need enteral support, and those with severe malnutrition due to malabsorption may need parenteral support.

So far, RCD management suggestions are based on small retrospective studies and expert opinion, with minimal prospective data and no Food and Drug Administration–approved therapies. The goals should be to improve symptoms and duodenal mucosal abnormalities, manage malnutrition, and prevent lymphoma. Glucocorticoids are considered first-line therapy, typically open-capsule budesonide given as 3 mg three times daily. Prednisone serves as an alternative with proven efficacy but a higher risk for adverse effects.

The optimal choice for second-line therapy is unknown, but the addition of an immunosuppressant agent to steroids appears to be effective in RCD1, including azathioprine, mercaptopurine, and tioguanine. The best treatment for RCD2 is unknown, though clinical response has been reported with steroids, and cladribine has been well tolerated in some patients.

Patients with RCD who don’t respond to steroids may benefit from referral to a center with expertise for management or evaluation for inclusion in clinical trials. Frequent medical visits are advised until the disease is well controlled, with regular follow-up after that. 

Ultimately, “patients with RCD benefit from evaluation and regular follow-up by a multidisciplinary team, including gastroenterologists and dietitians, to assess clinical and histologic response to therapy,” the authors wrote. “Identify local experts with expertise in celiac disease to assist with management.”

The authors reported no grant support or funding sources for this study. One author has received research report from Freenome, and another is on the celiac disease advisory board for Takeda. The remaining authors disclosed no conflicts.

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

Doctors caring for patients taking steroids now have broader flexibility for which drugs to use to prevent osteoporosis associated with the medications.

The American College of Rheumatology (ACR) has released an updated guideline that advises treatment providers on when and how long to prescribe therapies that prevent or treat glucocorticoid-induced osteoporosis (GIOP). Since the ACR last updated the guideline in 2017, the Food and Drug Administration has approved new treatments for osteoporosis, which are now included in the recommendations.

The new guideline also advises physicians that they may need to transition patients to a second treatment after concluding a first course – so-called sequential therapy – to better protect them against bone loss and fracture. It also offers detailed instructions for which drugs to use, when, and how long these medications should be administered for patients taking glucocorticoids over a long period of time.

The guideline’s inclusion of sequential therapy is significant and will be helpful to practicing clinicians, according to S.B. Tanner IV, MD, director of the Osteoporosis Clinic at Vanderbilt Health, Nashville, Tenn.

“For the first time, the ACR has offered guidance for starting and stopping treatments,” Dr. Tanner said. “This guideline supports awareness that osteoporosis is lifelong – something that will consistently need monitoring.”

An estimated 2.5 million Americans use glucocorticoids, according to a 2013 study in Arthritis Care & Research. Meanwhile, a 2019 study of residents in Denmark found 3% of people in the country were prescribed glucocorticoids annually. That study estimated 54% of glucocorticoid users were female and found the percentage of people taking glucocorticoids increased with age.

Glucocorticoids are used to treat a variety of inflammatory conditions, from multiple sclerosis to lupus, and often are prescribed to transplant patients to prevent their immune systems from rejecting new organs. When taken over time these medications can cause osteoporosis, which in turn raises the risk of fracture.

More than 10% of patients who receive long-term glucocorticoid treatment are diagnosed with clinical fractures. In addition, even low-dose glucocorticoid therapy is associated with a bone loss rate of 10% per year for a patient.

Osteoporosis prevention

After stopping some prevention therapies for GIOP, a high risk of bone loss or fracture still persists, according to Linda A. Russell, MD, director of the Osteoporosis and Metabolic Bone Health Center for the Hospital for Special Surgery, New York, and co-principal investigator of the new guideline.

“We wanted to be sure the need for sequential treatment is adequately communicated, including to patients who might not know they need to start a second medication,” Dr. Russell said.

Physicians and patients must be aware that when completing a course of one GIOP treatment, another drug for the condition should be started, as specified in the guideline.

“Early intervention can prevent glucocorticoid-induced fractures that can lead to substantial morbidity and increased mortality,” said Mary Beth Humphrey, MD, PhD, interim vice president for research at the University of Oklahoma Health Sciences Center in Oklahoma City and co-principal investigator of the ACR guideline.

Anyone can fracture

While age and other risk factors, including menopause, increase the risk of developing GIOP, bone loss can occur rapidly for a patient of any age.

Even a glucocorticoid dose as low as 2.5 mg will increase the risk of vertebral fractures, with some occurring as soon as 3 months after treatment starts, Dr. Humphrey said. For patients taking up to 7.5 mg daily, the risk of vertebral fracture doubles. Doses greater than 10 mg daily for more than 3 months raise the likelihood of a vertebral fracture by a factor of 14, and result in a 300% increase in the likelihood of hip fractures, according to Dr. Humphrey.

“When on steroids, even patients with high bone density scores can fracture,” Dr. Tanner said. “The 2017 guideline was almost too elaborate in its effort to calculate risk. The updated guideline acknowledges moderate risk and suggests that this is a group of patients who need treatment.”
 

Rank ordering adds flexibility

The updated ACR guideline no longer ranks medications based on patient fracture data, side effects, cost care, and whether the drug is provided through injection, pill, or IV.

All of the preventive treatments the panel recommends reduce the risk of steroid-induced bone loss, Dr. Humphrey said.

“We thought the 2017 guideline was too restrictive,” Dr. Russell said. “We’re giving physicians and patients more leeway to choose a medication based on their preferences.”

Patient preference of delivery mechanism – such as a desire for pills only – can now be weighed more heavily into drug treatment decisions.

“In the exam room, there are three dynamics going on: What the patient wants, what the doctor knows is most effective, and what the insurer will pay,” Dr. Tanner said. “Doing away with rank ordering opens up the conversation beyond cost to consider all those factors.”

The guideline team conducted a systematic literature review for clinical questions on nonpharmacologic and pharmacologic treatment addressed in the 2017 guideline, and for questions on new pharmacologic treatments, discontinuation of medications, and sequential and combination therapy. The voting panel consisted of two patient representatives and 13 experts representing adult and pediatric rheumatology and endocrinology, nephrology, and gastroenterology.

A full manuscript has been submitted for publication in Arthritis & Rheumatology and Arthritis Care and Research for peer review, and is expected to publish in early 2023.

Dr. Humphrey and Dr. Russell, the co-principal investigators for the guideline, and Dr. Rubin have disclosed no relevant financial relationships. Dr. Tanner reported a current research grant funded by Amgen through the University of Alabama at Birmingham and being a paid course instructor for the International Society for Clinical Densitometry bone density course, Osteoporosis Essentials.

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

Doctors caring for patients taking steroids now have broader flexibility for which drugs to use to prevent osteoporosis associated with the medications.

The American College of Rheumatology (ACR) has released an updated guideline that advises treatment providers on when and how long to prescribe therapies that prevent or treat glucocorticoid-induced osteoporosis (GIOP). Since the ACR last updated the guideline in 2017, the Food and Drug Administration has approved new treatments for osteoporosis, which are now included in the recommendations.

The new guideline also advises physicians that they may need to transition patients to a second treatment after concluding a first course – so-called sequential therapy – to better protect them against bone loss and fracture. It also offers detailed instructions for which drugs to use, when, and how long these medications should be administered for patients taking glucocorticoids over a long period of time.

The guideline’s inclusion of sequential therapy is significant and will be helpful to practicing clinicians, according to S.B. Tanner IV, MD, director of the Osteoporosis Clinic at Vanderbilt Health, Nashville, Tenn.

“For the first time, the ACR has offered guidance for starting and stopping treatments,” Dr. Tanner said. “This guideline supports awareness that osteoporosis is lifelong – something that will consistently need monitoring.”

An estimated 2.5 million Americans use glucocorticoids, according to a 2013 study in Arthritis Care & Research. Meanwhile, a 2019 study of residents in Denmark found 3% of people in the country were prescribed glucocorticoids annually. That study estimated 54% of glucocorticoid users were female and found the percentage of people taking glucocorticoids increased with age.

Glucocorticoids are used to treat a variety of inflammatory conditions, from multiple sclerosis to lupus, and often are prescribed to transplant patients to prevent their immune systems from rejecting new organs. When taken over time these medications can cause osteoporosis, which in turn raises the risk of fracture.

More than 10% of patients who receive long-term glucocorticoid treatment are diagnosed with clinical fractures. In addition, even low-dose glucocorticoid therapy is associated with a bone loss rate of 10% per year for a patient.

Osteoporosis prevention

After stopping some prevention therapies for GIOP, a high risk of bone loss or fracture still persists, according to Linda A. Russell, MD, director of the Osteoporosis and Metabolic Bone Health Center for the Hospital for Special Surgery, New York, and co-principal investigator of the new guideline.

“We wanted to be sure the need for sequential treatment is adequately communicated, including to patients who might not know they need to start a second medication,” Dr. Russell said.

Physicians and patients must be aware that when completing a course of one GIOP treatment, another drug for the condition should be started, as specified in the guideline.

“Early intervention can prevent glucocorticoid-induced fractures that can lead to substantial morbidity and increased mortality,” said Mary Beth Humphrey, MD, PhD, interim vice president for research at the University of Oklahoma Health Sciences Center in Oklahoma City and co-principal investigator of the ACR guideline.

Anyone can fracture

While age and other risk factors, including menopause, increase the risk of developing GIOP, bone loss can occur rapidly for a patient of any age.

Even a glucocorticoid dose as low as 2.5 mg will increase the risk of vertebral fractures, with some occurring as soon as 3 months after treatment starts, Dr. Humphrey said. For patients taking up to 7.5 mg daily, the risk of vertebral fracture doubles. Doses greater than 10 mg daily for more than 3 months raise the likelihood of a vertebral fracture by a factor of 14, and result in a 300% increase in the likelihood of hip fractures, according to Dr. Humphrey.

“When on steroids, even patients with high bone density scores can fracture,” Dr. Tanner said. “The 2017 guideline was almost too elaborate in its effort to calculate risk. The updated guideline acknowledges moderate risk and suggests that this is a group of patients who need treatment.”
 

Rank ordering adds flexibility

The updated ACR guideline no longer ranks medications based on patient fracture data, side effects, cost care, and whether the drug is provided through injection, pill, or IV.

All of the preventive treatments the panel recommends reduce the risk of steroid-induced bone loss, Dr. Humphrey said.

“We thought the 2017 guideline was too restrictive,” Dr. Russell said. “We’re giving physicians and patients more leeway to choose a medication based on their preferences.”

Patient preference of delivery mechanism – such as a desire for pills only – can now be weighed more heavily into drug treatment decisions.

“In the exam room, there are three dynamics going on: What the patient wants, what the doctor knows is most effective, and what the insurer will pay,” Dr. Tanner said. “Doing away with rank ordering opens up the conversation beyond cost to consider all those factors.”

The guideline team conducted a systematic literature review for clinical questions on nonpharmacologic and pharmacologic treatment addressed in the 2017 guideline, and for questions on new pharmacologic treatments, discontinuation of medications, and sequential and combination therapy. The voting panel consisted of two patient representatives and 13 experts representing adult and pediatric rheumatology and endocrinology, nephrology, and gastroenterology.

A full manuscript has been submitted for publication in Arthritis & Rheumatology and Arthritis Care and Research for peer review, and is expected to publish in early 2023.

Dr. Humphrey and Dr. Russell, the co-principal investigators for the guideline, and Dr. Rubin have disclosed no relevant financial relationships. Dr. Tanner reported a current research grant funded by Amgen through the University of Alabama at Birmingham and being a paid course instructor for the International Society for Clinical Densitometry bone density course, Osteoporosis Essentials.

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

Doctors caring for patients taking steroids now have broader flexibility for which drugs to use to prevent osteoporosis associated with the medications.

The American College of Rheumatology (ACR) has released an updated guideline that advises treatment providers on when and how long to prescribe therapies that prevent or treat glucocorticoid-induced osteoporosis (GIOP). Since the ACR last updated the guideline in 2017, the Food and Drug Administration has approved new treatments for osteoporosis, which are now included in the recommendations.

The new guideline also advises physicians that they may need to transition patients to a second treatment after concluding a first course – so-called sequential therapy – to better protect them against bone loss and fracture. It also offers detailed instructions for which drugs to use, when, and how long these medications should be administered for patients taking glucocorticoids over a long period of time.

The guideline’s inclusion of sequential therapy is significant and will be helpful to practicing clinicians, according to S.B. Tanner IV, MD, director of the Osteoporosis Clinic at Vanderbilt Health, Nashville, Tenn.

“For the first time, the ACR has offered guidance for starting and stopping treatments,” Dr. Tanner said. “This guideline supports awareness that osteoporosis is lifelong – something that will consistently need monitoring.”

An estimated 2.5 million Americans use glucocorticoids, according to a 2013 study in Arthritis Care & Research. Meanwhile, a 2019 study of residents in Denmark found 3% of people in the country were prescribed glucocorticoids annually. That study estimated 54% of glucocorticoid users were female and found the percentage of people taking glucocorticoids increased with age.

Glucocorticoids are used to treat a variety of inflammatory conditions, from multiple sclerosis to lupus, and often are prescribed to transplant patients to prevent their immune systems from rejecting new organs. When taken over time these medications can cause osteoporosis, which in turn raises the risk of fracture.

More than 10% of patients who receive long-term glucocorticoid treatment are diagnosed with clinical fractures. In addition, even low-dose glucocorticoid therapy is associated with a bone loss rate of 10% per year for a patient.

Osteoporosis prevention

After stopping some prevention therapies for GIOP, a high risk of bone loss or fracture still persists, according to Linda A. Russell, MD, director of the Osteoporosis and Metabolic Bone Health Center for the Hospital for Special Surgery, New York, and co-principal investigator of the new guideline.

“We wanted to be sure the need for sequential treatment is adequately communicated, including to patients who might not know they need to start a second medication,” Dr. Russell said.

Physicians and patients must be aware that when completing a course of one GIOP treatment, another drug for the condition should be started, as specified in the guideline.

“Early intervention can prevent glucocorticoid-induced fractures that can lead to substantial morbidity and increased mortality,” said Mary Beth Humphrey, MD, PhD, interim vice president for research at the University of Oklahoma Health Sciences Center in Oklahoma City and co-principal investigator of the ACR guideline.

Anyone can fracture

While age and other risk factors, including menopause, increase the risk of developing GIOP, bone loss can occur rapidly for a patient of any age.

Even a glucocorticoid dose as low as 2.5 mg will increase the risk of vertebral fractures, with some occurring as soon as 3 months after treatment starts, Dr. Humphrey said. For patients taking up to 7.5 mg daily, the risk of vertebral fracture doubles. Doses greater than 10 mg daily for more than 3 months raise the likelihood of a vertebral fracture by a factor of 14, and result in a 300% increase in the likelihood of hip fractures, according to Dr. Humphrey.

“When on steroids, even patients with high bone density scores can fracture,” Dr. Tanner said. “The 2017 guideline was almost too elaborate in its effort to calculate risk. The updated guideline acknowledges moderate risk and suggests that this is a group of patients who need treatment.”
 

Rank ordering adds flexibility

The updated ACR guideline no longer ranks medications based on patient fracture data, side effects, cost care, and whether the drug is provided through injection, pill, or IV.

All of the preventive treatments the panel recommends reduce the risk of steroid-induced bone loss, Dr. Humphrey said.

“We thought the 2017 guideline was too restrictive,” Dr. Russell said. “We’re giving physicians and patients more leeway to choose a medication based on their preferences.”

Patient preference of delivery mechanism – such as a desire for pills only – can now be weighed more heavily into drug treatment decisions.

“In the exam room, there are three dynamics going on: What the patient wants, what the doctor knows is most effective, and what the insurer will pay,” Dr. Tanner said. “Doing away with rank ordering opens up the conversation beyond cost to consider all those factors.”

The guideline team conducted a systematic literature review for clinical questions on nonpharmacologic and pharmacologic treatment addressed in the 2017 guideline, and for questions on new pharmacologic treatments, discontinuation of medications, and sequential and combination therapy. The voting panel consisted of two patient representatives and 13 experts representing adult and pediatric rheumatology and endocrinology, nephrology, and gastroenterology.

A full manuscript has been submitted for publication in Arthritis & Rheumatology and Arthritis Care and Research for peer review, and is expected to publish in early 2023.

Dr. Humphrey and Dr. Russell, the co-principal investigators for the guideline, and Dr. Rubin have disclosed no relevant financial relationships. Dr. Tanner reported a current research grant funded by Amgen through the University of Alabama at Birmingham and being a paid course instructor for the International Society for Clinical Densitometry bone density course, Osteoporosis Essentials.

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

In some cases, bruising or bleeding from bleeding disorders may look like signs of child abuse, but new guidance may help clinicians distinguish one from the other.

On Sept. 19 the American Academy of Pediatrics published two reports – a clinical report and a technical report – in the October 2022 issue of Pediatrics on evaluating for bleeding disorders when child abuse is suspected.

The reports were written by the AAP Section on Hematology/Oncology and the AAP Council on Child Abuse and Neglect.
 

One doesn’t rule out the other

The reports emphasize that laboratory testing of bleeding cannot always rule out abuse, just as a history of trauma (accidental or nonaccidental) may not rule out a bleeding disorder or other medical condition.

In the clinical report, led by James Anderst, MD, MSCI, with the division of child adversity and resilience, Children’s Mercy Hospital, University of Missouri–Kansas City, the researchers note that infants are at especially high risk of abusive bruising/bleeding, but bleeding disorders may also present in infancy.

The authors give an example of a situation when taking a thorough history won’t necessarily rule out a bleeding disorder: Male infants who have been circumcised with no significant bleeding issues may still have a bleeding disorder. Therefore, laboratory evaluations are often needed to detect disordered bleeding.

Children’s medications should be documented, the authors note, because certain drugs, such as nonsteroidal anti-inflammatory drugs, some antibiotics, antiepileptics, and herbal supplements, can affect tests that might be used to detect bleeding disorders.

Likewise, asking about restrictive or unusual diets or alternative therapies is important as some could increase the likelihood of bleeding/bruising.

Signs that bleeding disorder is not likely

The authors advise that, if a child has any of the following, an evaluation for a bleeding disorder is generally not needed:

• Caregivers’ description of trauma sufficiently explains the bruising.
• The child or an independent witness can provide a history of abuse or nonabusive trauma that explains the bruising.
• The outline of the bruising follows an object or hand pattern.
• The location of the bruising is on the ears, neck, or genitals.

“Bruising to the ears, neck, or genitals is rarely seen in either accidental injuries or in children with bleeding disorders,” the authors write.

Specification of which locations for injuries are more indicative of abuse in both mobile and immobile children was among the most important information from the paper, Seattle pediatrician Timothy Joos, MD, said in an interview.

Also very helpful, he said, was the listing of which tests should be done if bruising looks like potential abuse.

The authors write that if bruising is concerning for abuse that necessitates evaluation for bleeding disorders, the following tests should be done: PT (prothrombin time); aPTT (activated partial thromboplastin time); von Willebrand Factor (VWF) activity (Ristocetin cofactor); factor VIII activity level; factor IX activity level; and a complete blood count, including platelets.

“I think that’s what a lot of us suspected, but there’s not a lot of summary evidence regarding that until now,” Dr. Joos said.

Case-by-case decisions on when to test

The decision on whether to evaluate for a bleeding disorder may be made case by case.

If there is no obvious known trauma or intracranial hemorrhage (ICH), particularly subdural hematoma (SDH) in a nonmobile child, abuse should be suspected, the authors write.

They acknowledge that children can have ICH, such as a small SDH or an epidural hematoma, under the point of impact from a short fall.

“However,” the authors write, “short falls rarely result in significant brain injury.”

Conditions may affect screening tests

Screening tests for bleeding disorders can be falsely positive or falsely negative, the authors caution in the technical report, led by Shannon Carpenter, MD, MS, with the department of pediatrics, University of Missouri–Kansas City.

• If coagulation laboratory test specimens sit in a hot metal box all day, for instance, factor levels may be falsely low, the authors explain.
• Conversely, factors such as VWF and factor VIII are acute-phase reactants and factor levels will be deceptively high if blood specimens are taken in a stressful time.
• Patients who have a traumatic brain injury often show temporary coagulopathy that does not signal a congenital disorder.

Vitamin K deficiency

The technical report explains that if an infant, typically younger than 6 months, presents with bleeding/bruising that raises flags for abuse and has a long PT, clinicians should confirm vitamin K was provided at birth and/or testing for vitamin K deficiency should be performed.

Not all states require vitamin K to be administered at birth and some parents refuse it. Deficiency can lead to bleeding in the skin or from mucosal surfaces from circumcision, generalized ecchymoses, and large intramuscular hemorrhages or ICH.

When infants don’t get vitamin K at birth, vitamin K deficiency bleeding (VKDB) is seen most often in the first days of life, the technical report states. It can also occur 1-3 months after birth.

“Late VKDB occurs from the first month to 3 months after birth,” the authors write. “This deficiency is more prevalent in breast-fed babies, because human milk contains less vitamin K than does cow milk.”

Overall, the authors write, extensive lab tests are usually not necessary, given the rarity of most bleeding disorders and specific clinical factors that decrease the odds that a bleeding disorder caused the child’s findings.

Dr. Joos said the decisions described in this paper are the kind that can keep pediatricians up at night.

“Any kind of guidance is helpful in these difficult cases,” he said. “These are scenarios that can often happen in the middle of the night, and you’re often struggling with evidence or past experience that can help you make some of these decisions.”

Authors of the reports and Dr. Joos declared no relevant financial relationships.

In some cases, bruising or bleeding from bleeding disorders may look like signs of child abuse, but new guidance may help clinicians distinguish one from the other.

On Sept. 19 the American Academy of Pediatrics published two reports – a clinical report and a technical report – in the October 2022 issue of Pediatrics on evaluating for bleeding disorders when child abuse is suspected.

The reports were written by the AAP Section on Hematology/Oncology and the AAP Council on Child Abuse and Neglect.
 

One doesn’t rule out the other

The reports emphasize that laboratory testing of bleeding cannot always rule out abuse, just as a history of trauma (accidental or nonaccidental) may not rule out a bleeding disorder or other medical condition.

In the clinical report, led by James Anderst, MD, MSCI, with the division of child adversity and resilience, Children’s Mercy Hospital, University of Missouri–Kansas City, the researchers note that infants are at especially high risk of abusive bruising/bleeding, but bleeding disorders may also present in infancy.

The authors give an example of a situation when taking a thorough history won’t necessarily rule out a bleeding disorder: Male infants who have been circumcised with no significant bleeding issues may still have a bleeding disorder. Therefore, laboratory evaluations are often needed to detect disordered bleeding.

Children’s medications should be documented, the authors note, because certain drugs, such as nonsteroidal anti-inflammatory drugs, some antibiotics, antiepileptics, and herbal supplements, can affect tests that might be used to detect bleeding disorders.

Likewise, asking about restrictive or unusual diets or alternative therapies is important as some could increase the likelihood of bleeding/bruising.

Signs that bleeding disorder is not likely

The authors advise that, if a child has any of the following, an evaluation for a bleeding disorder is generally not needed:

• Caregivers’ description of trauma sufficiently explains the bruising.
• The child or an independent witness can provide a history of abuse or nonabusive trauma that explains the bruising.
• The outline of the bruising follows an object or hand pattern.
• The location of the bruising is on the ears, neck, or genitals.

“Bruising to the ears, neck, or genitals is rarely seen in either accidental injuries or in children with bleeding disorders,” the authors write.

Specification of which locations for injuries are more indicative of abuse in both mobile and immobile children was among the most important information from the paper, Seattle pediatrician Timothy Joos, MD, said in an interview.

Also very helpful, he said, was the listing of which tests should be done if bruising looks like potential abuse.

The authors write that if bruising is concerning for abuse that necessitates evaluation for bleeding disorders, the following tests should be done: PT (prothrombin time); aPTT (activated partial thromboplastin time); von Willebrand Factor (VWF) activity (Ristocetin cofactor); factor VIII activity level; factor IX activity level; and a complete blood count, including platelets.

“I think that’s what a lot of us suspected, but there’s not a lot of summary evidence regarding that until now,” Dr. Joos said.

Case-by-case decisions on when to test

The decision on whether to evaluate for a bleeding disorder may be made case by case.

If there is no obvious known trauma or intracranial hemorrhage (ICH), particularly subdural hematoma (SDH) in a nonmobile child, abuse should be suspected, the authors write.

They acknowledge that children can have ICH, such as a small SDH or an epidural hematoma, under the point of impact from a short fall.

“However,” the authors write, “short falls rarely result in significant brain injury.”

Conditions may affect screening tests

Screening tests for bleeding disorders can be falsely positive or falsely negative, the authors caution in the technical report, led by Shannon Carpenter, MD, MS, with the department of pediatrics, University of Missouri–Kansas City.

• If coagulation laboratory test specimens sit in a hot metal box all day, for instance, factor levels may be falsely low, the authors explain.
• Conversely, factors such as VWF and factor VIII are acute-phase reactants and factor levels will be deceptively high if blood specimens are taken in a stressful time.
• Patients who have a traumatic brain injury often show temporary coagulopathy that does not signal a congenital disorder.

Vitamin K deficiency

The technical report explains that if an infant, typically younger than 6 months, presents with bleeding/bruising that raises flags for abuse and has a long PT, clinicians should confirm vitamin K was provided at birth and/or testing for vitamin K deficiency should be performed.

Not all states require vitamin K to be administered at birth and some parents refuse it. Deficiency can lead to bleeding in the skin or from mucosal surfaces from circumcision, generalized ecchymoses, and large intramuscular hemorrhages or ICH.

When infants don’t get vitamin K at birth, vitamin K deficiency bleeding (VKDB) is seen most often in the first days of life, the technical report states. It can also occur 1-3 months after birth.

“Late VKDB occurs from the first month to 3 months after birth,” the authors write. “This deficiency is more prevalent in breast-fed babies, because human milk contains less vitamin K than does cow milk.”

Overall, the authors write, extensive lab tests are usually not necessary, given the rarity of most bleeding disorders and specific clinical factors that decrease the odds that a bleeding disorder caused the child’s findings.

Dr. Joos said the decisions described in this paper are the kind that can keep pediatricians up at night.

“Any kind of guidance is helpful in these difficult cases,” he said. “These are scenarios that can often happen in the middle of the night, and you’re often struggling with evidence or past experience that can help you make some of these decisions.”

Authors of the reports and Dr. Joos declared no relevant financial relationships.

In some cases, bruising or bleeding from bleeding disorders may look like signs of child abuse, but new guidance may help clinicians distinguish one from the other.

On Sept. 19 the American Academy of Pediatrics published two reports – a clinical report and a technical report – in the October 2022 issue of Pediatrics on evaluating for bleeding disorders when child abuse is suspected.

The reports were written by the AAP Section on Hematology/Oncology and the AAP Council on Child Abuse and Neglect.
 

One doesn’t rule out the other

The reports emphasize that laboratory testing of bleeding cannot always rule out abuse, just as a history of trauma (accidental or nonaccidental) may not rule out a bleeding disorder or other medical condition.

In the clinical report, led by James Anderst, MD, MSCI, with the division of child adversity and resilience, Children’s Mercy Hospital, University of Missouri–Kansas City, the researchers note that infants are at especially high risk of abusive bruising/bleeding, but bleeding disorders may also present in infancy.

The authors give an example of a situation when taking a thorough history won’t necessarily rule out a bleeding disorder: Male infants who have been circumcised with no significant bleeding issues may still have a bleeding disorder. Therefore, laboratory evaluations are often needed to detect disordered bleeding.

Children’s medications should be documented, the authors note, because certain drugs, such as nonsteroidal anti-inflammatory drugs, some antibiotics, antiepileptics, and herbal supplements, can affect tests that might be used to detect bleeding disorders.

Likewise, asking about restrictive or unusual diets or alternative therapies is important as some could increase the likelihood of bleeding/bruising.

Signs that bleeding disorder is not likely

The authors advise that, if a child has any of the following, an evaluation for a bleeding disorder is generally not needed:

• Caregivers’ description of trauma sufficiently explains the bruising.
• The child or an independent witness can provide a history of abuse or nonabusive trauma that explains the bruising.
• The outline of the bruising follows an object or hand pattern.
• The location of the bruising is on the ears, neck, or genitals.

“Bruising to the ears, neck, or genitals is rarely seen in either accidental injuries or in children with bleeding disorders,” the authors write.

Specification of which locations for injuries are more indicative of abuse in both mobile and immobile children was among the most important information from the paper, Seattle pediatrician Timothy Joos, MD, said in an interview.

Also very helpful, he said, was the listing of which tests should be done if bruising looks like potential abuse.

The authors write that if bruising is concerning for abuse that necessitates evaluation for bleeding disorders, the following tests should be done: PT (prothrombin time); aPTT (activated partial thromboplastin time); von Willebrand Factor (VWF) activity (Ristocetin cofactor); factor VIII activity level; factor IX activity level; and a complete blood count, including platelets.

“I think that’s what a lot of us suspected, but there’s not a lot of summary evidence regarding that until now,” Dr. Joos said.

Case-by-case decisions on when to test

The decision on whether to evaluate for a bleeding disorder may be made case by case.

If there is no obvious known trauma or intracranial hemorrhage (ICH), particularly subdural hematoma (SDH) in a nonmobile child, abuse should be suspected, the authors write.

They acknowledge that children can have ICH, such as a small SDH or an epidural hematoma, under the point of impact from a short fall.

“However,” the authors write, “short falls rarely result in significant brain injury.”

Conditions may affect screening tests

Screening tests for bleeding disorders can be falsely positive or falsely negative, the authors caution in the technical report, led by Shannon Carpenter, MD, MS, with the department of pediatrics, University of Missouri–Kansas City.

• If coagulation laboratory test specimens sit in a hot metal box all day, for instance, factor levels may be falsely low, the authors explain.
• Conversely, factors such as VWF and factor VIII are acute-phase reactants and factor levels will be deceptively high if blood specimens are taken in a stressful time.
• Patients who have a traumatic brain injury often show temporary coagulopathy that does not signal a congenital disorder.

Vitamin K deficiency

The technical report explains that if an infant, typically younger than 6 months, presents with bleeding/bruising that raises flags for abuse and has a long PT, clinicians should confirm vitamin K was provided at birth and/or testing for vitamin K deficiency should be performed.

Not all states require vitamin K to be administered at birth and some parents refuse it. Deficiency can lead to bleeding in the skin or from mucosal surfaces from circumcision, generalized ecchymoses, and large intramuscular hemorrhages or ICH.

When infants don’t get vitamin K at birth, vitamin K deficiency bleeding (VKDB) is seen most often in the first days of life, the technical report states. It can also occur 1-3 months after birth.

“Late VKDB occurs from the first month to 3 months after birth,” the authors write. “This deficiency is more prevalent in breast-fed babies, because human milk contains less vitamin K than does cow milk.”

Overall, the authors write, extensive lab tests are usually not necessary, given the rarity of most bleeding disorders and specific clinical factors that decrease the odds that a bleeding disorder caused the child’s findings.

Dr. Joos said the decisions described in this paper are the kind that can keep pediatricians up at night.

“Any kind of guidance is helpful in these difficult cases,” he said. “These are scenarios that can often happen in the middle of the night, and you’re often struggling with evidence or past experience that can help you make some of these decisions.”

Authors of the reports and Dr. Joos declared no relevant financial relationships.