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Tool in development aims to steer telehealth visit appropriateness in rheumatology
Researchers have created a model to suggest which rheumatology visits can be effectively carried out via telehealth and which should remain in-person visits. The model not only could help to alleviate the decision burden on providers but also help to navigate how to incorporate telehealth into daily rheumatology practice as the COVID-19 pandemic subsides, experts say.
The beginning of the pandemic quickly drove rheumatology practices to adopt telehealth – which in the past has been studied only in selective groups of relatively stable patients. In Duke University’s department of rheumatology, nearly 90% of visits were conducted via telehealth for several weeks in April and May 2020, said David L. Leverenz, MD, an assistant professor of medicine at Duke University in Durham, N.C.
Since then, the practice has continued providing telehealth for a wider variety of patients: patients with high disease activity, those with low disease activity, people living 3 hours away or just 5 minutes from the medical center.
“Although the pandemic has really improved, and certainly we feel very safe providing in-person care, we’ve realized that it’s actually really possible to provide telehealth care to a lot of patients,” he said.
The model was then piloted with four Duke University rheumatologists for visits that took place from March through July 2022. A month prior to visits, researchers provided the rheumatologists a list of in-patient visits that the model suggested could be changed to telehealth visits. The list also included false changes, in which randomly selected visits were presented as being recommended for telehealth, although the model had not actually recommended the changes.
Dr. Leverenz and colleagues measured how frequently providers agreed with changes recommended by the model and the false changes. If a provider accepted a model-suggested change, the patient was contacted to either accept or reject the proposed switch. If a provider agreed with a false change, no additional action was taken.
Of the 201 patient encounters, there were 101 model-recommended changes and 100 artificial changes. Nearly all (99%) model-recommended changes suggested moving from in-person visits to telehealth visits. There was one recommendation to change a scheduled telehealth encounter to an in-person encounter. Of the false recommendations, 90 were for scheduled in-person visits, and 10 were for scheduled telehealth appointments.
Providers agreed with 71% of the model-recommended changes and with 21% of the false changes. Dr. Leverenz and colleagues reported “moderate agreement” between providers and model recommendations, reflected by a Cohen kappa coefficient of 0.45.
“This lined up pretty well with what providers thought was appropriate for the patient when presented with the information, and it also showed that, on top of current practice, that the model really does have the ability to expand appropriate telehealth care, which is really what we’re looking to do,” Dr. Leverenz said.
The article describing these results was published in Arthritis Care and Research.
Perhaps unsurprisingly, clinician preference for and experience with telemedicine were the biggest predictors of whether changes suggested by the model were accepted.
Focus model to specific diagnoses or many?
Currently, clinicians who are already juggling many other responsibilities throughout the day must use their own judgment to determine whether telemedicine may be appropriate. A model such as this could help alleviate that decision burden, said Kathleen Fear, PhD, the director of data and analytics at the University of Rochester Medical Center Health Lab, in New York.
“A model that can help with scheduling or prompt a provider or patient for when a visit is appropriate for telemedicine seems like a really effective way to make the most of telemedicine while reducing potential burden on providers,” she said.
Dr. Leverenz imagines that this model could be embedded into electronic health records as a “decision support tool” to aid discussions between patients and providers on whether telehealth might be appropriate for upcoming visits.
But developing a model that can generate predictions for the wide variety of conditions seen in daily rheumatology practice can be a challenge, said Christine Peoples, MD, a clinical associate professor of medicine and director of the tele-rheumatology program at the University of Pittsburgh.
“If you focus the model to certain diagnoses, at least in the beginning, that’s very helpful, because it’s too difficult to have one model for every single reason that folks see a rheumatologist,” she said.
Daniel A. Albert, MD, a professor of medicine and pediatrics at the Geisel School of Medicine at Dartmouth in Hanover, N,H., agreed. The model is “a good start,” he said, and highlights that tele-rheumatology continues to be underutilized in practice. But he argued that the moderate agreement found with the model was relatively low.
A more focused algorithm that targets a single or several more common conditions may be more accurate, he said. “You probably want to break it down,” Dr. Albert said.
But Dr. Leverenz argued that the novelty of this model is that it incorporates the many different conditions seen in daily rheumatology practice, whereas previous programs utilizing telehealth focused on specific conditions and patients with low disease activity.
In addition, the model is currently provider centric and does not take patient preference into account, Dr. Albert added. Dr. Leverenz said that that is the next step in further developing this model. He is currently conducting qualitative analyses with patients to better understand what patients think and how often their views on telehealth differ from that of their care providers.
“Hopefully, we can expand appropriate telehealth visits by teaching providers not just to do what they think is right for the patient but also meet the patient’s expectations and needs, based on what we learn,” he said.
The study was funded by a grant from Pfizer. Dr. Leverenz has received grants from Pfizer and has served as a consultant for Sanofi. None of the study’s other authors report relevant financial relationships. Dr. Peoples is an educational consultant on telehealth for Pfizer. Dr. Alberts has previously received grant funding from Pfizer. Dr. Fear has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers have created a model to suggest which rheumatology visits can be effectively carried out via telehealth and which should remain in-person visits. The model not only could help to alleviate the decision burden on providers but also help to navigate how to incorporate telehealth into daily rheumatology practice as the COVID-19 pandemic subsides, experts say.
The beginning of the pandemic quickly drove rheumatology practices to adopt telehealth – which in the past has been studied only in selective groups of relatively stable patients. In Duke University’s department of rheumatology, nearly 90% of visits were conducted via telehealth for several weeks in April and May 2020, said David L. Leverenz, MD, an assistant professor of medicine at Duke University in Durham, N.C.
Since then, the practice has continued providing telehealth for a wider variety of patients: patients with high disease activity, those with low disease activity, people living 3 hours away or just 5 minutes from the medical center.
“Although the pandemic has really improved, and certainly we feel very safe providing in-person care, we’ve realized that it’s actually really possible to provide telehealth care to a lot of patients,” he said.
The model was then piloted with four Duke University rheumatologists for visits that took place from March through July 2022. A month prior to visits, researchers provided the rheumatologists a list of in-patient visits that the model suggested could be changed to telehealth visits. The list also included false changes, in which randomly selected visits were presented as being recommended for telehealth, although the model had not actually recommended the changes.
Dr. Leverenz and colleagues measured how frequently providers agreed with changes recommended by the model and the false changes. If a provider accepted a model-suggested change, the patient was contacted to either accept or reject the proposed switch. If a provider agreed with a false change, no additional action was taken.
Of the 201 patient encounters, there were 101 model-recommended changes and 100 artificial changes. Nearly all (99%) model-recommended changes suggested moving from in-person visits to telehealth visits. There was one recommendation to change a scheduled telehealth encounter to an in-person encounter. Of the false recommendations, 90 were for scheduled in-person visits, and 10 were for scheduled telehealth appointments.
Providers agreed with 71% of the model-recommended changes and with 21% of the false changes. Dr. Leverenz and colleagues reported “moderate agreement” between providers and model recommendations, reflected by a Cohen kappa coefficient of 0.45.
“This lined up pretty well with what providers thought was appropriate for the patient when presented with the information, and it also showed that, on top of current practice, that the model really does have the ability to expand appropriate telehealth care, which is really what we’re looking to do,” Dr. Leverenz said.
The article describing these results was published in Arthritis Care and Research.
Perhaps unsurprisingly, clinician preference for and experience with telemedicine were the biggest predictors of whether changes suggested by the model were accepted.
Focus model to specific diagnoses or many?
Currently, clinicians who are already juggling many other responsibilities throughout the day must use their own judgment to determine whether telemedicine may be appropriate. A model such as this could help alleviate that decision burden, said Kathleen Fear, PhD, the director of data and analytics at the University of Rochester Medical Center Health Lab, in New York.
“A model that can help with scheduling or prompt a provider or patient for when a visit is appropriate for telemedicine seems like a really effective way to make the most of telemedicine while reducing potential burden on providers,” she said.
Dr. Leverenz imagines that this model could be embedded into electronic health records as a “decision support tool” to aid discussions between patients and providers on whether telehealth might be appropriate for upcoming visits.
But developing a model that can generate predictions for the wide variety of conditions seen in daily rheumatology practice can be a challenge, said Christine Peoples, MD, a clinical associate professor of medicine and director of the tele-rheumatology program at the University of Pittsburgh.
“If you focus the model to certain diagnoses, at least in the beginning, that’s very helpful, because it’s too difficult to have one model for every single reason that folks see a rheumatologist,” she said.
Daniel A. Albert, MD, a professor of medicine and pediatrics at the Geisel School of Medicine at Dartmouth in Hanover, N,H., agreed. The model is “a good start,” he said, and highlights that tele-rheumatology continues to be underutilized in practice. But he argued that the moderate agreement found with the model was relatively low.
A more focused algorithm that targets a single or several more common conditions may be more accurate, he said. “You probably want to break it down,” Dr. Albert said.
But Dr. Leverenz argued that the novelty of this model is that it incorporates the many different conditions seen in daily rheumatology practice, whereas previous programs utilizing telehealth focused on specific conditions and patients with low disease activity.
In addition, the model is currently provider centric and does not take patient preference into account, Dr. Albert added. Dr. Leverenz said that that is the next step in further developing this model. He is currently conducting qualitative analyses with patients to better understand what patients think and how often their views on telehealth differ from that of their care providers.
“Hopefully, we can expand appropriate telehealth visits by teaching providers not just to do what they think is right for the patient but also meet the patient’s expectations and needs, based on what we learn,” he said.
The study was funded by a grant from Pfizer. Dr. Leverenz has received grants from Pfizer and has served as a consultant for Sanofi. None of the study’s other authors report relevant financial relationships. Dr. Peoples is an educational consultant on telehealth for Pfizer. Dr. Alberts has previously received grant funding from Pfizer. Dr. Fear has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Researchers have created a model to suggest which rheumatology visits can be effectively carried out via telehealth and which should remain in-person visits. The model not only could help to alleviate the decision burden on providers but also help to navigate how to incorporate telehealth into daily rheumatology practice as the COVID-19 pandemic subsides, experts say.
The beginning of the pandemic quickly drove rheumatology practices to adopt telehealth – which in the past has been studied only in selective groups of relatively stable patients. In Duke University’s department of rheumatology, nearly 90% of visits were conducted via telehealth for several weeks in April and May 2020, said David L. Leverenz, MD, an assistant professor of medicine at Duke University in Durham, N.C.
Since then, the practice has continued providing telehealth for a wider variety of patients: patients with high disease activity, those with low disease activity, people living 3 hours away or just 5 minutes from the medical center.
“Although the pandemic has really improved, and certainly we feel very safe providing in-person care, we’ve realized that it’s actually really possible to provide telehealth care to a lot of patients,” he said.
The model was then piloted with four Duke University rheumatologists for visits that took place from March through July 2022. A month prior to visits, researchers provided the rheumatologists a list of in-patient visits that the model suggested could be changed to telehealth visits. The list also included false changes, in which randomly selected visits were presented as being recommended for telehealth, although the model had not actually recommended the changes.
Dr. Leverenz and colleagues measured how frequently providers agreed with changes recommended by the model and the false changes. If a provider accepted a model-suggested change, the patient was contacted to either accept or reject the proposed switch. If a provider agreed with a false change, no additional action was taken.
Of the 201 patient encounters, there were 101 model-recommended changes and 100 artificial changes. Nearly all (99%) model-recommended changes suggested moving from in-person visits to telehealth visits. There was one recommendation to change a scheduled telehealth encounter to an in-person encounter. Of the false recommendations, 90 were for scheduled in-person visits, and 10 were for scheduled telehealth appointments.
Providers agreed with 71% of the model-recommended changes and with 21% of the false changes. Dr. Leverenz and colleagues reported “moderate agreement” between providers and model recommendations, reflected by a Cohen kappa coefficient of 0.45.
“This lined up pretty well with what providers thought was appropriate for the patient when presented with the information, and it also showed that, on top of current practice, that the model really does have the ability to expand appropriate telehealth care, which is really what we’re looking to do,” Dr. Leverenz said.
The article describing these results was published in Arthritis Care and Research.
Perhaps unsurprisingly, clinician preference for and experience with telemedicine were the biggest predictors of whether changes suggested by the model were accepted.
Focus model to specific diagnoses or many?
Currently, clinicians who are already juggling many other responsibilities throughout the day must use their own judgment to determine whether telemedicine may be appropriate. A model such as this could help alleviate that decision burden, said Kathleen Fear, PhD, the director of data and analytics at the University of Rochester Medical Center Health Lab, in New York.
“A model that can help with scheduling or prompt a provider or patient for when a visit is appropriate for telemedicine seems like a really effective way to make the most of telemedicine while reducing potential burden on providers,” she said.
Dr. Leverenz imagines that this model could be embedded into electronic health records as a “decision support tool” to aid discussions between patients and providers on whether telehealth might be appropriate for upcoming visits.
But developing a model that can generate predictions for the wide variety of conditions seen in daily rheumatology practice can be a challenge, said Christine Peoples, MD, a clinical associate professor of medicine and director of the tele-rheumatology program at the University of Pittsburgh.
“If you focus the model to certain diagnoses, at least in the beginning, that’s very helpful, because it’s too difficult to have one model for every single reason that folks see a rheumatologist,” she said.
Daniel A. Albert, MD, a professor of medicine and pediatrics at the Geisel School of Medicine at Dartmouth in Hanover, N,H., agreed. The model is “a good start,” he said, and highlights that tele-rheumatology continues to be underutilized in practice. But he argued that the moderate agreement found with the model was relatively low.
A more focused algorithm that targets a single or several more common conditions may be more accurate, he said. “You probably want to break it down,” Dr. Albert said.
But Dr. Leverenz argued that the novelty of this model is that it incorporates the many different conditions seen in daily rheumatology practice, whereas previous programs utilizing telehealth focused on specific conditions and patients with low disease activity.
In addition, the model is currently provider centric and does not take patient preference into account, Dr. Albert added. Dr. Leverenz said that that is the next step in further developing this model. He is currently conducting qualitative analyses with patients to better understand what patients think and how often their views on telehealth differ from that of their care providers.
“Hopefully, we can expand appropriate telehealth visits by teaching providers not just to do what they think is right for the patient but also meet the patient’s expectations and needs, based on what we learn,” he said.
The study was funded by a grant from Pfizer. Dr. Leverenz has received grants from Pfizer and has served as a consultant for Sanofi. None of the study’s other authors report relevant financial relationships. Dr. Peoples is an educational consultant on telehealth for Pfizer. Dr. Alberts has previously received grant funding from Pfizer. Dr. Fear has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ARTHRITIS CARE AND RESEARCH
CHEST philanthropy: Moving into the future
In an ideal world, change would be progressive, the direction would be clear, and adoption would be easy. We learned in these past few years that sometimes change cannot wait. The vulnerabilities of the health care system were laid bare by the pandemic, including vast disparities in treatment and the urgent need to grow our profession.
In the light of these truths, CHEST looked within and asked a difficult question: Are we doing everything we can? This question probably sounds very familiar – one you ask every day, one you know the importance of asking. It was time we asked it of ourselves.
Milestones are a good time to reevaluate
Philanthropy is not new to CHEST. We celebrated 25 years of the CHEST Foundation in Nashville during CHEST 2022. Stories about community and clinical research grants were circulated in website blogs, emails, and newsletters and on social media for years. Our committee member volunteers worked hard developing accurate and credible patient education content for the CHEST Foundation website. Because of our faithful donors, communities around the world had access to better medical care and healthier environments.
This is amazing work, but it was time to ask:
- What can CHEST provide that others cannot?
- Where are the gaps we can fill?
- What is our community passionate about changing?
Working collectively, CHEST and CHEST Foundation leadership, along with staff, rigorously reviewed the success of our past fundraising efforts, areas of commitment our donors had specified, and the direction of interest our membership was leading us toward – like social accountability, growth and diversification of our profession, grassroots community impact, and partnerships to expand our reach. The process took nearly a year to complete – but, in the realm of big changes, that’s equal to the time needed for one good, deep breath.
Focusing on significant change means narrowing our scope
Meeting these goals would mean changing how we worked and letting go of areas better served elsewhere. CHEST needed to:
1. Align philanthropy with our mission to elevate the value placed on giving, making it a core priority and responsibility of CHEST as an organization.
2. Consolidate philanthropy under CHEST to reduce administrative costs and create efficiencies, allowing more funds to go directly to our philanthropic efforts.
3. Establish clear and transparent areas of giving that resonate with our members as a way to grow our impact and make real change.
With the full support of the CHEST Board of Regents, the CHEST Foundation Board of Advisors – under the guidance of Advisory Chair, Robert De Marco, MD, FCCP, and CHEST Foundation President, Ian Nathanson, MD, FCCP – approved a merger of the CHEST Foundation with CHEST.
In order to increase our impact and create greater awareness of CHEST philanthropic efforts, the Board of Advisors got to work defining a giving strategy that would meet the philanthropic goals and priorities of the CHEST membership. Four areas were defined and are referred to as our philanthropic pillars: clinical research, community impact, support of the profession, and dedication to education.
These pillars were approved by the Board of Regents at their spring leadership meeting.
Giving goals without support are just dreams
This transition puts the responsibility for funding the giving pillars in the hands of CHEST. The first step is ensuring the members see the impact of their donations.
“When you see your donation in action, you never doubt that you made a good decision,” said CHEST CEO, Robert A. Musacchio, PhD. “If we can show that to every member, the next 25 years of CHEST philanthropy are limitless.”
Helping connect donors to that experience is Meggie Cramer, the new Director of Philanthropy and Advancement , who has experience working directly with health care systems like Rush University Medical Center in Chicago and Hospital Sister Health System in Green Bay, Wisconsin.
“When you are giving to programs you are passionate about, you feel good about being a part of making a difference,” explained Cramer. “That’s my goal – to help our members find areas they care about and know their gift is part of creating real change.”
For frequently asked questions about the transition, please visit our website.
In an ideal world, change would be progressive, the direction would be clear, and adoption would be easy. We learned in these past few years that sometimes change cannot wait. The vulnerabilities of the health care system were laid bare by the pandemic, including vast disparities in treatment and the urgent need to grow our profession.
In the light of these truths, CHEST looked within and asked a difficult question: Are we doing everything we can? This question probably sounds very familiar – one you ask every day, one you know the importance of asking. It was time we asked it of ourselves.
Milestones are a good time to reevaluate
Philanthropy is not new to CHEST. We celebrated 25 years of the CHEST Foundation in Nashville during CHEST 2022. Stories about community and clinical research grants were circulated in website blogs, emails, and newsletters and on social media for years. Our committee member volunteers worked hard developing accurate and credible patient education content for the CHEST Foundation website. Because of our faithful donors, communities around the world had access to better medical care and healthier environments.
This is amazing work, but it was time to ask:
- What can CHEST provide that others cannot?
- Where are the gaps we can fill?
- What is our community passionate about changing?
Working collectively, CHEST and CHEST Foundation leadership, along with staff, rigorously reviewed the success of our past fundraising efforts, areas of commitment our donors had specified, and the direction of interest our membership was leading us toward – like social accountability, growth and diversification of our profession, grassroots community impact, and partnerships to expand our reach. The process took nearly a year to complete – but, in the realm of big changes, that’s equal to the time needed for one good, deep breath.
Focusing on significant change means narrowing our scope
Meeting these goals would mean changing how we worked and letting go of areas better served elsewhere. CHEST needed to:
1. Align philanthropy with our mission to elevate the value placed on giving, making it a core priority and responsibility of CHEST as an organization.
2. Consolidate philanthropy under CHEST to reduce administrative costs and create efficiencies, allowing more funds to go directly to our philanthropic efforts.
3. Establish clear and transparent areas of giving that resonate with our members as a way to grow our impact and make real change.
With the full support of the CHEST Board of Regents, the CHEST Foundation Board of Advisors – under the guidance of Advisory Chair, Robert De Marco, MD, FCCP, and CHEST Foundation President, Ian Nathanson, MD, FCCP – approved a merger of the CHEST Foundation with CHEST.
In order to increase our impact and create greater awareness of CHEST philanthropic efforts, the Board of Advisors got to work defining a giving strategy that would meet the philanthropic goals and priorities of the CHEST membership. Four areas were defined and are referred to as our philanthropic pillars: clinical research, community impact, support of the profession, and dedication to education.
These pillars were approved by the Board of Regents at their spring leadership meeting.
Giving goals without support are just dreams
This transition puts the responsibility for funding the giving pillars in the hands of CHEST. The first step is ensuring the members see the impact of their donations.
“When you see your donation in action, you never doubt that you made a good decision,” said CHEST CEO, Robert A. Musacchio, PhD. “If we can show that to every member, the next 25 years of CHEST philanthropy are limitless.”
Helping connect donors to that experience is Meggie Cramer, the new Director of Philanthropy and Advancement , who has experience working directly with health care systems like Rush University Medical Center in Chicago and Hospital Sister Health System in Green Bay, Wisconsin.
“When you are giving to programs you are passionate about, you feel good about being a part of making a difference,” explained Cramer. “That’s my goal – to help our members find areas they care about and know their gift is part of creating real change.”
For frequently asked questions about the transition, please visit our website.
In an ideal world, change would be progressive, the direction would be clear, and adoption would be easy. We learned in these past few years that sometimes change cannot wait. The vulnerabilities of the health care system were laid bare by the pandemic, including vast disparities in treatment and the urgent need to grow our profession.
In the light of these truths, CHEST looked within and asked a difficult question: Are we doing everything we can? This question probably sounds very familiar – one you ask every day, one you know the importance of asking. It was time we asked it of ourselves.
Milestones are a good time to reevaluate
Philanthropy is not new to CHEST. We celebrated 25 years of the CHEST Foundation in Nashville during CHEST 2022. Stories about community and clinical research grants were circulated in website blogs, emails, and newsletters and on social media for years. Our committee member volunteers worked hard developing accurate and credible patient education content for the CHEST Foundation website. Because of our faithful donors, communities around the world had access to better medical care and healthier environments.
This is amazing work, but it was time to ask:
- What can CHEST provide that others cannot?
- Where are the gaps we can fill?
- What is our community passionate about changing?
Working collectively, CHEST and CHEST Foundation leadership, along with staff, rigorously reviewed the success of our past fundraising efforts, areas of commitment our donors had specified, and the direction of interest our membership was leading us toward – like social accountability, growth and diversification of our profession, grassroots community impact, and partnerships to expand our reach. The process took nearly a year to complete – but, in the realm of big changes, that’s equal to the time needed for one good, deep breath.
Focusing on significant change means narrowing our scope
Meeting these goals would mean changing how we worked and letting go of areas better served elsewhere. CHEST needed to:
1. Align philanthropy with our mission to elevate the value placed on giving, making it a core priority and responsibility of CHEST as an organization.
2. Consolidate philanthropy under CHEST to reduce administrative costs and create efficiencies, allowing more funds to go directly to our philanthropic efforts.
3. Establish clear and transparent areas of giving that resonate with our members as a way to grow our impact and make real change.
With the full support of the CHEST Board of Regents, the CHEST Foundation Board of Advisors – under the guidance of Advisory Chair, Robert De Marco, MD, FCCP, and CHEST Foundation President, Ian Nathanson, MD, FCCP – approved a merger of the CHEST Foundation with CHEST.
In order to increase our impact and create greater awareness of CHEST philanthropic efforts, the Board of Advisors got to work defining a giving strategy that would meet the philanthropic goals and priorities of the CHEST membership. Four areas were defined and are referred to as our philanthropic pillars: clinical research, community impact, support of the profession, and dedication to education.
These pillars were approved by the Board of Regents at their spring leadership meeting.
Giving goals without support are just dreams
This transition puts the responsibility for funding the giving pillars in the hands of CHEST. The first step is ensuring the members see the impact of their donations.
“When you see your donation in action, you never doubt that you made a good decision,” said CHEST CEO, Robert A. Musacchio, PhD. “If we can show that to every member, the next 25 years of CHEST philanthropy are limitless.”
Helping connect donors to that experience is Meggie Cramer, the new Director of Philanthropy and Advancement , who has experience working directly with health care systems like Rush University Medical Center in Chicago and Hospital Sister Health System in Green Bay, Wisconsin.
“When you are giving to programs you are passionate about, you feel good about being a part of making a difference,” explained Cramer. “That’s my goal – to help our members find areas they care about and know their gift is part of creating real change.”
For frequently asked questions about the transition, please visit our website.
New guidelines for determining brain death released
The consensus practice guideline on brain death, also known as death by neurologic criteria (BD/DNC), was developed by a panel of 20 experts from different specialties, institutions, and medical societies.
As with previous guidelines, the updated version stipulates that brain death should be declared when a patient with a known cause of catastrophic brain injury has permanent loss of function of the brain, including the brain stem, which results in coma, brain stem areflexia, and apnea in the setting of an adequate stimulus.
But the updated version also clarifies questions on neurological examinations and apnea testing and offers new guidance on pre-evaluation targets for blood pressure and body temperature and evaluating brain death in patients who are pregnant, are on extracorporeal membrane oxygenation, or have an injury to the base of the brain.
Also, for the first time, the guidance clarifies that clinicians don’t need to obtain consent before performing a brain death evaluation, unless institutional policy, state laws, or regulations stipulate otherwise.
“The 2023 guidelines will be considered the standard of care in the U.S.,” lead author David M. Greer, MD, chair and chief of neurology, Boston University, and chief of neurology, Boston Medical Center, said in an interview. “Each hospital in the U.S. is responsible for its own policy for BD/DNC determination, and our hope is that they will quickly revise their policies in accordance with this new national standard.”
The guidelines, which are accompanied by a three-page checklist and a free digital app, were published online in Neurology.
Four years in the making
Work on the 85 recommendations in the new report began more than 4 years ago as a collaborative effort by the American Academy of Neurology, the American Academy of Pediatrics, the Child Neurology Society, and the Society of Critical Care Medicine.
A lack of high-quality evidence on brain death determination led panelists to devise an evidence-informed formal consensus process to develop the guidelines, which involved three rounds of anonymous voting on each recommendation and the rationales behind them.
The strength of each recommendation was based on the level of consensus reached through voting, with Level A denoting a recommendation that “must” be followed, Level B one that “should” be followed, and Level C one that “may” be followed.
The majority of recommendations received an A or B rating. Only one recommendation, about whether a second clinical exam is needed in adults, garnered a C rating.
In children, the guidelines recommend that clinicians must perform two clinical examinations and two apnea tests 12 hours apart. In adults, only one exam is required. Both of those recommendations were rated Level A. A recommendation for a second exam in adults received the single Level C rating.
A uniform set of guidelines?
The new guidelines replace adult practice guidance published by AAN in 2010 and guideline for infants and children released in 2011 by AAP, CNS, and SCCM, and for the first time combine brain death guidelines for adult and pediatric patients into one document.
“It is important for clinicians to review the new guideline carefully and ensure their hospital brain death guidelines are updated to be consistent with the new guideline in order to prevent inaccurate determinations of death,” guidelines coauthor Ariane Lewis, MD, NYU Langone Health, New York, said in an interview.
The 1981 Uniform Determination of Death Act (UDDA) is the legal foundation for the declaration of BD/DNC in the United States, but it only stipulates that brain death determination must be made in accordance with accepted medical standards.
There is no single national standard, and states and hospitals are free to adopt their own, which many have done. One goal of the new guidelines was to create a uniform set of guidelines that all institutions follow.
“This is a step toward having a set of guidelines that are accepted by most of the societies and clinical specialties involved in this sort of diagnosis,” that could lead to a national-level policy, Fernando Goldenberg, MD, professor of neurology and director of neuroscience critical care, University of Chicago Medicine, said in an interview.
Dr. Goldenberg was not part of the panel that developed the updated guidelines, but was a coauthor of a consensus statement from the World Brain Death Project in 2020.
Developing a singular global guideline for brain death determination is unlikely, Dr. Goldenberg said. Policies vary widely across the world, and some countries don’t even recognize brain death.
“But this attempts to unify things at the U.S. level, which is very important,” he said.
Permanent vs. irreversible
Dr. Goldenberg said that combining adult and pediatric guidelines into one document will be very helpful for clinicians like him who treat patients from age 16 years and up.
The expanded guidance on apnea testing, recommendations on specific ancillary tests to use or avoid, and inclusion of language stipulating that prior consent is not needed to perform a brain death evaluation are also useful.
He also noted that the section on credentialing and training of clinicians who perform BD/DNC evaluations recognizes advanced practice providers, the first time he recalls seeing these professionals included in brain death guidelines.
However, the panel’s decision to use the term “permanent” to describe loss of brain function instead of “irreversible” gave Dr. Goldenberg pause.
The UDDA provides that an individual is declared legally dead when “circulatory and respiratory functions irreversibly stop; or all functions of the entire brain, including the brain stem, irreversibly stop.”
Earlier in October, the American College of Physicians released a position paper on cardiorespiratory death determination that called for a revision of the UDDA language.
The ACP suggested that “irreversibly” be replaced with “permanently” with regard to the cessation of circulatory and respiratory functions, but that “irreversible” be kept in the description of brain death.
“Permanent means that there is damage that is potentially reversible and irreversible means that the damage is so profound, it cannot be reversed even if an attempt to do so is performed,” Dr. Goldenberg said.
Even though the World Brain Death Project, on which he worked, also used “permanent” to describe brain function loss, Dr. Goldenberg said he aligns with ACP’s position.
“The understanding of brain death is that the damage is so profound, it is irreversible, even if you were to try,” he said. “Therefore, I think that the most appropriate term for brain death should be irreversible as opposed to permanent.”
The report was funded by the American Academy of Neurology. Dr. Greer has received travel funding from Boston University; serves as editor-in-chief for Seminars in Neurology; receives publishing royalties for 50 Studies Every Neurologist Should Know and Successful Leadership in Academic Medicine; has received honoraria from AAN; has received research funding from Becton, Dickinson, and Company; and has served as expert witness in legal proceedings. Dr. Lewis has received honoraria from AAN and Neurodiem, serves as Neurology deputy editor of disputes and debates, and serves as deputy editor of seminars in Neurology. Dr. Goldenberg reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The consensus practice guideline on brain death, also known as death by neurologic criteria (BD/DNC), was developed by a panel of 20 experts from different specialties, institutions, and medical societies.
As with previous guidelines, the updated version stipulates that brain death should be declared when a patient with a known cause of catastrophic brain injury has permanent loss of function of the brain, including the brain stem, which results in coma, brain stem areflexia, and apnea in the setting of an adequate stimulus.
But the updated version also clarifies questions on neurological examinations and apnea testing and offers new guidance on pre-evaluation targets for blood pressure and body temperature and evaluating brain death in patients who are pregnant, are on extracorporeal membrane oxygenation, or have an injury to the base of the brain.
Also, for the first time, the guidance clarifies that clinicians don’t need to obtain consent before performing a brain death evaluation, unless institutional policy, state laws, or regulations stipulate otherwise.
“The 2023 guidelines will be considered the standard of care in the U.S.,” lead author David M. Greer, MD, chair and chief of neurology, Boston University, and chief of neurology, Boston Medical Center, said in an interview. “Each hospital in the U.S. is responsible for its own policy for BD/DNC determination, and our hope is that they will quickly revise their policies in accordance with this new national standard.”
The guidelines, which are accompanied by a three-page checklist and a free digital app, were published online in Neurology.
Four years in the making
Work on the 85 recommendations in the new report began more than 4 years ago as a collaborative effort by the American Academy of Neurology, the American Academy of Pediatrics, the Child Neurology Society, and the Society of Critical Care Medicine.
A lack of high-quality evidence on brain death determination led panelists to devise an evidence-informed formal consensus process to develop the guidelines, which involved three rounds of anonymous voting on each recommendation and the rationales behind them.
The strength of each recommendation was based on the level of consensus reached through voting, with Level A denoting a recommendation that “must” be followed, Level B one that “should” be followed, and Level C one that “may” be followed.
The majority of recommendations received an A or B rating. Only one recommendation, about whether a second clinical exam is needed in adults, garnered a C rating.
In children, the guidelines recommend that clinicians must perform two clinical examinations and two apnea tests 12 hours apart. In adults, only one exam is required. Both of those recommendations were rated Level A. A recommendation for a second exam in adults received the single Level C rating.
A uniform set of guidelines?
The new guidelines replace adult practice guidance published by AAN in 2010 and guideline for infants and children released in 2011 by AAP, CNS, and SCCM, and for the first time combine brain death guidelines for adult and pediatric patients into one document.
“It is important for clinicians to review the new guideline carefully and ensure their hospital brain death guidelines are updated to be consistent with the new guideline in order to prevent inaccurate determinations of death,” guidelines coauthor Ariane Lewis, MD, NYU Langone Health, New York, said in an interview.
The 1981 Uniform Determination of Death Act (UDDA) is the legal foundation for the declaration of BD/DNC in the United States, but it only stipulates that brain death determination must be made in accordance with accepted medical standards.
There is no single national standard, and states and hospitals are free to adopt their own, which many have done. One goal of the new guidelines was to create a uniform set of guidelines that all institutions follow.
“This is a step toward having a set of guidelines that are accepted by most of the societies and clinical specialties involved in this sort of diagnosis,” that could lead to a national-level policy, Fernando Goldenberg, MD, professor of neurology and director of neuroscience critical care, University of Chicago Medicine, said in an interview.
Dr. Goldenberg was not part of the panel that developed the updated guidelines, but was a coauthor of a consensus statement from the World Brain Death Project in 2020.
Developing a singular global guideline for brain death determination is unlikely, Dr. Goldenberg said. Policies vary widely across the world, and some countries don’t even recognize brain death.
“But this attempts to unify things at the U.S. level, which is very important,” he said.
Permanent vs. irreversible
Dr. Goldenberg said that combining adult and pediatric guidelines into one document will be very helpful for clinicians like him who treat patients from age 16 years and up.
The expanded guidance on apnea testing, recommendations on specific ancillary tests to use or avoid, and inclusion of language stipulating that prior consent is not needed to perform a brain death evaluation are also useful.
He also noted that the section on credentialing and training of clinicians who perform BD/DNC evaluations recognizes advanced practice providers, the first time he recalls seeing these professionals included in brain death guidelines.
However, the panel’s decision to use the term “permanent” to describe loss of brain function instead of “irreversible” gave Dr. Goldenberg pause.
The UDDA provides that an individual is declared legally dead when “circulatory and respiratory functions irreversibly stop; or all functions of the entire brain, including the brain stem, irreversibly stop.”
Earlier in October, the American College of Physicians released a position paper on cardiorespiratory death determination that called for a revision of the UDDA language.
The ACP suggested that “irreversibly” be replaced with “permanently” with regard to the cessation of circulatory and respiratory functions, but that “irreversible” be kept in the description of brain death.
“Permanent means that there is damage that is potentially reversible and irreversible means that the damage is so profound, it cannot be reversed even if an attempt to do so is performed,” Dr. Goldenberg said.
Even though the World Brain Death Project, on which he worked, also used “permanent” to describe brain function loss, Dr. Goldenberg said he aligns with ACP’s position.
“The understanding of brain death is that the damage is so profound, it is irreversible, even if you were to try,” he said. “Therefore, I think that the most appropriate term for brain death should be irreversible as opposed to permanent.”
The report was funded by the American Academy of Neurology. Dr. Greer has received travel funding from Boston University; serves as editor-in-chief for Seminars in Neurology; receives publishing royalties for 50 Studies Every Neurologist Should Know and Successful Leadership in Academic Medicine; has received honoraria from AAN; has received research funding from Becton, Dickinson, and Company; and has served as expert witness in legal proceedings. Dr. Lewis has received honoraria from AAN and Neurodiem, serves as Neurology deputy editor of disputes and debates, and serves as deputy editor of seminars in Neurology. Dr. Goldenberg reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The consensus practice guideline on brain death, also known as death by neurologic criteria (BD/DNC), was developed by a panel of 20 experts from different specialties, institutions, and medical societies.
As with previous guidelines, the updated version stipulates that brain death should be declared when a patient with a known cause of catastrophic brain injury has permanent loss of function of the brain, including the brain stem, which results in coma, brain stem areflexia, and apnea in the setting of an adequate stimulus.
But the updated version also clarifies questions on neurological examinations and apnea testing and offers new guidance on pre-evaluation targets for blood pressure and body temperature and evaluating brain death in patients who are pregnant, are on extracorporeal membrane oxygenation, or have an injury to the base of the brain.
Also, for the first time, the guidance clarifies that clinicians don’t need to obtain consent before performing a brain death evaluation, unless institutional policy, state laws, or regulations stipulate otherwise.
“The 2023 guidelines will be considered the standard of care in the U.S.,” lead author David M. Greer, MD, chair and chief of neurology, Boston University, and chief of neurology, Boston Medical Center, said in an interview. “Each hospital in the U.S. is responsible for its own policy for BD/DNC determination, and our hope is that they will quickly revise their policies in accordance with this new national standard.”
The guidelines, which are accompanied by a three-page checklist and a free digital app, were published online in Neurology.
Four years in the making
Work on the 85 recommendations in the new report began more than 4 years ago as a collaborative effort by the American Academy of Neurology, the American Academy of Pediatrics, the Child Neurology Society, and the Society of Critical Care Medicine.
A lack of high-quality evidence on brain death determination led panelists to devise an evidence-informed formal consensus process to develop the guidelines, which involved three rounds of anonymous voting on each recommendation and the rationales behind them.
The strength of each recommendation was based on the level of consensus reached through voting, with Level A denoting a recommendation that “must” be followed, Level B one that “should” be followed, and Level C one that “may” be followed.
The majority of recommendations received an A or B rating. Only one recommendation, about whether a second clinical exam is needed in adults, garnered a C rating.
In children, the guidelines recommend that clinicians must perform two clinical examinations and two apnea tests 12 hours apart. In adults, only one exam is required. Both of those recommendations were rated Level A. A recommendation for a second exam in adults received the single Level C rating.
A uniform set of guidelines?
The new guidelines replace adult practice guidance published by AAN in 2010 and guideline for infants and children released in 2011 by AAP, CNS, and SCCM, and for the first time combine brain death guidelines for adult and pediatric patients into one document.
“It is important for clinicians to review the new guideline carefully and ensure their hospital brain death guidelines are updated to be consistent with the new guideline in order to prevent inaccurate determinations of death,” guidelines coauthor Ariane Lewis, MD, NYU Langone Health, New York, said in an interview.
The 1981 Uniform Determination of Death Act (UDDA) is the legal foundation for the declaration of BD/DNC in the United States, but it only stipulates that brain death determination must be made in accordance with accepted medical standards.
There is no single national standard, and states and hospitals are free to adopt their own, which many have done. One goal of the new guidelines was to create a uniform set of guidelines that all institutions follow.
“This is a step toward having a set of guidelines that are accepted by most of the societies and clinical specialties involved in this sort of diagnosis,” that could lead to a national-level policy, Fernando Goldenberg, MD, professor of neurology and director of neuroscience critical care, University of Chicago Medicine, said in an interview.
Dr. Goldenberg was not part of the panel that developed the updated guidelines, but was a coauthor of a consensus statement from the World Brain Death Project in 2020.
Developing a singular global guideline for brain death determination is unlikely, Dr. Goldenberg said. Policies vary widely across the world, and some countries don’t even recognize brain death.
“But this attempts to unify things at the U.S. level, which is very important,” he said.
Permanent vs. irreversible
Dr. Goldenberg said that combining adult and pediatric guidelines into one document will be very helpful for clinicians like him who treat patients from age 16 years and up.
The expanded guidance on apnea testing, recommendations on specific ancillary tests to use or avoid, and inclusion of language stipulating that prior consent is not needed to perform a brain death evaluation are also useful.
He also noted that the section on credentialing and training of clinicians who perform BD/DNC evaluations recognizes advanced practice providers, the first time he recalls seeing these professionals included in brain death guidelines.
However, the panel’s decision to use the term “permanent” to describe loss of brain function instead of “irreversible” gave Dr. Goldenberg pause.
The UDDA provides that an individual is declared legally dead when “circulatory and respiratory functions irreversibly stop; or all functions of the entire brain, including the brain stem, irreversibly stop.”
Earlier in October, the American College of Physicians released a position paper on cardiorespiratory death determination that called for a revision of the UDDA language.
The ACP suggested that “irreversibly” be replaced with “permanently” with regard to the cessation of circulatory and respiratory functions, but that “irreversible” be kept in the description of brain death.
“Permanent means that there is damage that is potentially reversible and irreversible means that the damage is so profound, it cannot be reversed even if an attempt to do so is performed,” Dr. Goldenberg said.
Even though the World Brain Death Project, on which he worked, also used “permanent” to describe brain function loss, Dr. Goldenberg said he aligns with ACP’s position.
“The understanding of brain death is that the damage is so profound, it is irreversible, even if you were to try,” he said. “Therefore, I think that the most appropriate term for brain death should be irreversible as opposed to permanent.”
The report was funded by the American Academy of Neurology. Dr. Greer has received travel funding from Boston University; serves as editor-in-chief for Seminars in Neurology; receives publishing royalties for 50 Studies Every Neurologist Should Know and Successful Leadership in Academic Medicine; has received honoraria from AAN; has received research funding from Becton, Dickinson, and Company; and has served as expert witness in legal proceedings. Dr. Lewis has received honoraria from AAN and Neurodiem, serves as Neurology deputy editor of disputes and debates, and serves as deputy editor of seminars in Neurology. Dr. Goldenberg reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
CHEST Advocates raises awareness against tobacco use
“Ew, gross.”
“Um, no way.”
“Of course not.”
Earlier this summer, I partnered with Dr. Melissa Keene, the medical director of a federally qualified health center in southwest Virginia, to talk about tobacco with middle school students. A few minutes after our arrival, it was clear to us that cigarettes weren’t cool anymore.
We asked hundreds of kids if they or their friends smoked cigarettes. The above quoted responses were repeated over and over.
Tobacco health advocates have spent decades working on public health messaging surrounding cigarette use, which is clearly working in this Virginian middle school.
But our patients, friends, and family who are already dependent on tobacco products still face addiction, morbidity, and premature mortality. And the ever-changing forms of tobacco delivery pose new challenges for our collective cessation efforts.
The Summer 2023 issue of CHEST Advocates features parents, lawyers, doctors, and nonprofit leaders who all share their inspiring stories of action in the fight against tobacco use.
Learn from tobacco experts, Dr. Susan Walley and Dr. Evan Stepp, about evidence-based approaches to tobacco cessation in young people –including why we should start having conversations by age 11 about smoking or vaping and why it’s important to inform youth about big tobacco marketing strategies.
Read an interview with Dr. Anne Melzer, who shares lessons from her career in tobacco advocacy centered in a US veteran population. Dr. Melzer suggests free resources that are available to all clinicians who sometimes struggle to help patients find the best way to quit.
Watch a video of Dr. Iyaad Hasan and Dr. Roy St. John, who run The Breathing Association, a nonprofit in Ohio serving individuals who are underinsured or uninsured. This organization offers a mobile medical unit that provides a free, evidenced-based program to help with smoking cessation via education, counseling, and personalized quit plans.
Learn from Natasha Phelps, JD, the Director of Equity-Centered Policies at The Center for Black Health & Equity. For more than 2 decades, this organization has focused on building community capacity to give local constituents the tools needed for sustainable health improvements, including tobacco cessation.
Hear from Dr. Panagiotis Behrakis, who – after decades of advocacy against tobacco use—the World Health Organization recognized in May for his Smoke Free Greece program. He explains why his work focuses on a two-pronged approach that places equal emphasis on both cessation and prevention.
Listen to a podcast featuring an amazing organization called Parents Against Vaping e-cigarettes, which started in response to a predatory marketing strategy by a tobacco company in a school system.
See how CHEST is fighting the battle against smoking and vaping, as told by Dr. Frank Leone, Chair of the Tobacco/Vaping Work Group for the CHEST Health Policy and Advocacy Committee. And, lastly, interact with a timeline of CHEST’s advocacy work in tobacco cessation and regulation through the decades.
As Dr. Melzer so eloquently stated in her interview featured in this issue, “tobacco cessation is a process that belongs to everybody, and, therefore, sometimes to nobody.” We hope this issue will inspire you to advocate for your patients and partner with your communities in our shared mission to improve education, awareness, and action against tobacco use.
“Ew, gross.”
“Um, no way.”
“Of course not.”
Earlier this summer, I partnered with Dr. Melissa Keene, the medical director of a federally qualified health center in southwest Virginia, to talk about tobacco with middle school students. A few minutes after our arrival, it was clear to us that cigarettes weren’t cool anymore.
We asked hundreds of kids if they or their friends smoked cigarettes. The above quoted responses were repeated over and over.
Tobacco health advocates have spent decades working on public health messaging surrounding cigarette use, which is clearly working in this Virginian middle school.
But our patients, friends, and family who are already dependent on tobacco products still face addiction, morbidity, and premature mortality. And the ever-changing forms of tobacco delivery pose new challenges for our collective cessation efforts.
The Summer 2023 issue of CHEST Advocates features parents, lawyers, doctors, and nonprofit leaders who all share their inspiring stories of action in the fight against tobacco use.
Learn from tobacco experts, Dr. Susan Walley and Dr. Evan Stepp, about evidence-based approaches to tobacco cessation in young people –including why we should start having conversations by age 11 about smoking or vaping and why it’s important to inform youth about big tobacco marketing strategies.
Read an interview with Dr. Anne Melzer, who shares lessons from her career in tobacco advocacy centered in a US veteran population. Dr. Melzer suggests free resources that are available to all clinicians who sometimes struggle to help patients find the best way to quit.
Watch a video of Dr. Iyaad Hasan and Dr. Roy St. John, who run The Breathing Association, a nonprofit in Ohio serving individuals who are underinsured or uninsured. This organization offers a mobile medical unit that provides a free, evidenced-based program to help with smoking cessation via education, counseling, and personalized quit plans.
Learn from Natasha Phelps, JD, the Director of Equity-Centered Policies at The Center for Black Health & Equity. For more than 2 decades, this organization has focused on building community capacity to give local constituents the tools needed for sustainable health improvements, including tobacco cessation.
Hear from Dr. Panagiotis Behrakis, who – after decades of advocacy against tobacco use—the World Health Organization recognized in May for his Smoke Free Greece program. He explains why his work focuses on a two-pronged approach that places equal emphasis on both cessation and prevention.
Listen to a podcast featuring an amazing organization called Parents Against Vaping e-cigarettes, which started in response to a predatory marketing strategy by a tobacco company in a school system.
See how CHEST is fighting the battle against smoking and vaping, as told by Dr. Frank Leone, Chair of the Tobacco/Vaping Work Group for the CHEST Health Policy and Advocacy Committee. And, lastly, interact with a timeline of CHEST’s advocacy work in tobacco cessation and regulation through the decades.
As Dr. Melzer so eloquently stated in her interview featured in this issue, “tobacco cessation is a process that belongs to everybody, and, therefore, sometimes to nobody.” We hope this issue will inspire you to advocate for your patients and partner with your communities in our shared mission to improve education, awareness, and action against tobacco use.
“Ew, gross.”
“Um, no way.”
“Of course not.”
Earlier this summer, I partnered with Dr. Melissa Keene, the medical director of a federally qualified health center in southwest Virginia, to talk about tobacco with middle school students. A few minutes after our arrival, it was clear to us that cigarettes weren’t cool anymore.
We asked hundreds of kids if they or their friends smoked cigarettes. The above quoted responses were repeated over and over.
Tobacco health advocates have spent decades working on public health messaging surrounding cigarette use, which is clearly working in this Virginian middle school.
But our patients, friends, and family who are already dependent on tobacco products still face addiction, morbidity, and premature mortality. And the ever-changing forms of tobacco delivery pose new challenges for our collective cessation efforts.
The Summer 2023 issue of CHEST Advocates features parents, lawyers, doctors, and nonprofit leaders who all share their inspiring stories of action in the fight against tobacco use.
Learn from tobacco experts, Dr. Susan Walley and Dr. Evan Stepp, about evidence-based approaches to tobacco cessation in young people –including why we should start having conversations by age 11 about smoking or vaping and why it’s important to inform youth about big tobacco marketing strategies.
Read an interview with Dr. Anne Melzer, who shares lessons from her career in tobacco advocacy centered in a US veteran population. Dr. Melzer suggests free resources that are available to all clinicians who sometimes struggle to help patients find the best way to quit.
Watch a video of Dr. Iyaad Hasan and Dr. Roy St. John, who run The Breathing Association, a nonprofit in Ohio serving individuals who are underinsured or uninsured. This organization offers a mobile medical unit that provides a free, evidenced-based program to help with smoking cessation via education, counseling, and personalized quit plans.
Learn from Natasha Phelps, JD, the Director of Equity-Centered Policies at The Center for Black Health & Equity. For more than 2 decades, this organization has focused on building community capacity to give local constituents the tools needed for sustainable health improvements, including tobacco cessation.
Hear from Dr. Panagiotis Behrakis, who – after decades of advocacy against tobacco use—the World Health Organization recognized in May for his Smoke Free Greece program. He explains why his work focuses on a two-pronged approach that places equal emphasis on both cessation and prevention.
Listen to a podcast featuring an amazing organization called Parents Against Vaping e-cigarettes, which started in response to a predatory marketing strategy by a tobacco company in a school system.
See how CHEST is fighting the battle against smoking and vaping, as told by Dr. Frank Leone, Chair of the Tobacco/Vaping Work Group for the CHEST Health Policy and Advocacy Committee. And, lastly, interact with a timeline of CHEST’s advocacy work in tobacco cessation and regulation through the decades.
As Dr. Melzer so eloquently stated in her interview featured in this issue, “tobacco cessation is a process that belongs to everybody, and, therefore, sometimes to nobody.” We hope this issue will inspire you to advocate for your patients and partner with your communities in our shared mission to improve education, awareness, and action against tobacco use.
3-D stereophotogrammetry helps detect progression of craniofacial morphea
TOPLINE:
over time.
METHODOLOGY:
- Existing tools that detect disease progression in patients with CM are limited.
- In a prospective cohort study, researchers evaluated the use of 3-D stereophotogrammetry, a noninvasive, radiation-free imaging modality, to detect disease progression in 27 consecutive patients with CM seen at Boston Children’s Hospital and Brigham and Women’s Hospital from April 1, 2019, to March 1, 2023.
- After clinical and 3-D stereophotogrammetry assessments were performed at 2- to 12-month intervals, the 3-D images were rated by an expert (a board-certified plastic craniofacial surgeon) and a nonexpert (a board-certified dermatologist) as demonstrating progression or no progression.
- Kappa coefficients were used to calculate inter-rater reliability.
TAKEAWAY:
- Most of the study participants (73%) were female, their median age was 14 years (range, 5-40 years), and each underwent 3-D stereophotogrammetry imaging at least two times spaced a median of 3 months apart.
- On the basis of clinical assessments during the 48-month study period, 10 patients (37%) experienced progression of their disease.
- 3-D stereophotogrammetry not only corroborated clinical impressions of disease progression with strong inter-rater reliability (kappa = 0.80; 95% confidence interval, 0.61-0.99), but it also detected occult progression of asymmetry not noted on clinical examination in three additional patients.
- In subgroup analyses, assessment of 3-D images demonstrated substantial to near-perfect inter-rater reliability in patients with Fitzpatrick skin types IV-VI.
IN PRACTICE:
“Further work is necessary to validate this measure in a larger cohort and to guide its incorporation into medical decision-making for patients with CM,” the researchers wrote.
SOURCE:
Katharina S. Shaw, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, led the research. The study was published online in JAMA Dermatology.
LIMITATIONS:
The sample was small, and a criterion standard for assessing CM was lacking.
DISCLOSURES:
The researchers reported having no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
over time.
METHODOLOGY:
- Existing tools that detect disease progression in patients with CM are limited.
- In a prospective cohort study, researchers evaluated the use of 3-D stereophotogrammetry, a noninvasive, radiation-free imaging modality, to detect disease progression in 27 consecutive patients with CM seen at Boston Children’s Hospital and Brigham and Women’s Hospital from April 1, 2019, to March 1, 2023.
- After clinical and 3-D stereophotogrammetry assessments were performed at 2- to 12-month intervals, the 3-D images were rated by an expert (a board-certified plastic craniofacial surgeon) and a nonexpert (a board-certified dermatologist) as demonstrating progression or no progression.
- Kappa coefficients were used to calculate inter-rater reliability.
TAKEAWAY:
- Most of the study participants (73%) were female, their median age was 14 years (range, 5-40 years), and each underwent 3-D stereophotogrammetry imaging at least two times spaced a median of 3 months apart.
- On the basis of clinical assessments during the 48-month study period, 10 patients (37%) experienced progression of their disease.
- 3-D stereophotogrammetry not only corroborated clinical impressions of disease progression with strong inter-rater reliability (kappa = 0.80; 95% confidence interval, 0.61-0.99), but it also detected occult progression of asymmetry not noted on clinical examination in three additional patients.
- In subgroup analyses, assessment of 3-D images demonstrated substantial to near-perfect inter-rater reliability in patients with Fitzpatrick skin types IV-VI.
IN PRACTICE:
“Further work is necessary to validate this measure in a larger cohort and to guide its incorporation into medical decision-making for patients with CM,” the researchers wrote.
SOURCE:
Katharina S. Shaw, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, led the research. The study was published online in JAMA Dermatology.
LIMITATIONS:
The sample was small, and a criterion standard for assessing CM was lacking.
DISCLOSURES:
The researchers reported having no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
over time.
METHODOLOGY:
- Existing tools that detect disease progression in patients with CM are limited.
- In a prospective cohort study, researchers evaluated the use of 3-D stereophotogrammetry, a noninvasive, radiation-free imaging modality, to detect disease progression in 27 consecutive patients with CM seen at Boston Children’s Hospital and Brigham and Women’s Hospital from April 1, 2019, to March 1, 2023.
- After clinical and 3-D stereophotogrammetry assessments were performed at 2- to 12-month intervals, the 3-D images were rated by an expert (a board-certified plastic craniofacial surgeon) and a nonexpert (a board-certified dermatologist) as demonstrating progression or no progression.
- Kappa coefficients were used to calculate inter-rater reliability.
TAKEAWAY:
- Most of the study participants (73%) were female, their median age was 14 years (range, 5-40 years), and each underwent 3-D stereophotogrammetry imaging at least two times spaced a median of 3 months apart.
- On the basis of clinical assessments during the 48-month study period, 10 patients (37%) experienced progression of their disease.
- 3-D stereophotogrammetry not only corroborated clinical impressions of disease progression with strong inter-rater reliability (kappa = 0.80; 95% confidence interval, 0.61-0.99), but it also detected occult progression of asymmetry not noted on clinical examination in three additional patients.
- In subgroup analyses, assessment of 3-D images demonstrated substantial to near-perfect inter-rater reliability in patients with Fitzpatrick skin types IV-VI.
IN PRACTICE:
“Further work is necessary to validate this measure in a larger cohort and to guide its incorporation into medical decision-making for patients with CM,” the researchers wrote.
SOURCE:
Katharina S. Shaw, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, led the research. The study was published online in JAMA Dermatology.
LIMITATIONS:
The sample was small, and a criterion standard for assessing CM was lacking.
DISCLOSURES:
The researchers reported having no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Pediatric sleep-disordered breathing linked to multilevel risk factors
In the first study evaluating pediatric sleep-disordered breathing (SDB) from both indoor environment and neighborhood perspectives, multilevel risk factors were revealed as being associated with SDB-related symptoms. Beyond known associations with environmental tobacco smoke (ETS), .
Although it has been well known that pediatric SDB affects low socioeconomic status (SES) children disproportionately, the roles of multilevel risk factor drivers including individual health, household SES, indoor exposures to environmental tobacco smoke, pests, and neighborhood characteristics have not been well studied, Gueye-Ndiaye et al. wrote in CHEST Pulmonary.
Pediatric SDB, a known risk factor for many health, neurobehavioral, and functional outcomes, includes habitual snoring and obstructive sleep apnea and may contribute to health disparities. Adenotonsillar hypertrophy and obesity are the most commonly recognized risk factors for SDB in generally healthy school-aged children. A role for other risk factors, however, is suggested by the fact that Black children have a fourfold increased risk for obstructive sleep apnea (OSA), compared with White children, unexplained by obesity, and have decreased response to treatment of OSA with adenotonsillectomy, compared with White children. Several studies point in the direction of neighborhood disadvantages as factors in heightened SDB prevalence or severity, Gueye-Ndiaye et al. stated.
The authors performed cross-sectional analyses on data recorded from 303 children (aged 6-12 years) enrolled in the Environmental Assessment of Sleep Youth (EASY) study from 2018 to 2022. Among them, 39% were Hispanic, Latino, Latina, or Spanish origin, 30% were Black or African American, 22% were White, and 11% were other. Maternal education attainment of a high school diploma or less was reported in 27%, and 65% of the sample lived in disadvantaged neighborhoods. Twenty-eight percent of children met criteria for objective SDB (Apnea-Hypopnea Index/Oxygen Desaturation Index ≥ 5/hr). Exposure documentation was informed by caregiver reports, assays of measured settled dust from the child’s bedroom, and neighborhood-level census data from which the Childhood Opportunity Index characterizing neighborhood disadvantage (ND) was derived. The study primary outcome was the SDB-related symptom burden assessed by the OSA-18 questionnaire total score.
Compared with children with no adverse indoor exposures to ETS and pests, children with such exposures had an approximately 4-12 point increase in total OSA-18 scores, and the increase among those with exposure to both ETS and pests was about 20 points (approximately a 1.3 standard deviation increase), Gueye-Ndiaye et al. reported.
In models adjusted for age, sex, minority race, and ethnicity, low maternal education was associated with a 7.55 (95% confidence interval, 3.44-11.66; P < .01) increased OSA-18 score. In models adjusted for sociodemographics including maternal education, history of asthma and allergic rhinitis were associated with a 13.63 (95% CI, 9.44-17.82; P < .01) and a 6.95 (95% CI, 2.62-11.29; P < .02) increased OSA-18 score, respectively. The authors noted that prior Canadian studies have shown OSA to be three times as likely in children with mothers reporting less than a high school education than in children with university educated mothers.
Speculating on the drivers of this association, they noted that the poor air quality due to tobacco smoke and allergen exposures to rodents, mold, and cockroaches are known contributors to asthma symptoms. Despite the differing pathogenesis of OSA and asthma, they suggest overlapping risk factors. Irritants and allergens may exacerbate SDB by stimulating immune responses manifested as adenotonsillar hypertrophy and by amplifying nasopharyngeal inflammation, adversely affecting upper airway patency. While ETS was not common in the sample, it was associated strongly with SDB. Gueye-Ndiaye et al. also showed associations between pest exposure, bedroom dust, and SDB symptoms. The findings, they concluded, support the importance of household- and bedroom-environmental conditions and sleep health.
OSA-18 scores were also elevated by about 7-14 points with allergic rhinitis and asthma, respectively. The findings, Gueye-Ndiaye et al. stated, underscore that asthma prevention strategies can be leveraged to address SDB disparities. No amplification of pest exposure effects, however, was found for asthma or allergic rhinitis.
“This is an incredibly important study, one that adds to our understanding of the risk factors that contribute to pediatric sleep health disparities,” said assistant professor of pediatrics Anne C. Coates, MD, Tufts University, Boston. “We have previously understood risk factors for sleep-disordered breathing like adenotonsillar hypertrophy, but this adds other elements like environmental tobacco smoke, pests, and home and neighborhood factors,” she told this news organization. “One of the most important takeaways is that beyond the importance of accurate diagnosis, there is the importance of advocating for our patients to ensure that they have the healthiest homes and neighborhoods. We need to inspire our colleagues to be advocates – for example – for pest mitigation, for antismoking policies, for every policy preventing the factors that contribute to the burden of disease.”
Dr. Coates is coauthor of “Advocacy and Health Equity: The Role of the Pediatric Pulmonologist,” currently in press (Clinics in Chest Medicine), and a member of the CHEST Physician Editorial Board.
The authors noted that a study limitation was that the sample was from one geographic area (Boston). Neither the authors nor Dr. Coates listed any conflicts.
In the first study evaluating pediatric sleep-disordered breathing (SDB) from both indoor environment and neighborhood perspectives, multilevel risk factors were revealed as being associated with SDB-related symptoms. Beyond known associations with environmental tobacco smoke (ETS), .
Although it has been well known that pediatric SDB affects low socioeconomic status (SES) children disproportionately, the roles of multilevel risk factor drivers including individual health, household SES, indoor exposures to environmental tobacco smoke, pests, and neighborhood characteristics have not been well studied, Gueye-Ndiaye et al. wrote in CHEST Pulmonary.
Pediatric SDB, a known risk factor for many health, neurobehavioral, and functional outcomes, includes habitual snoring and obstructive sleep apnea and may contribute to health disparities. Adenotonsillar hypertrophy and obesity are the most commonly recognized risk factors for SDB in generally healthy school-aged children. A role for other risk factors, however, is suggested by the fact that Black children have a fourfold increased risk for obstructive sleep apnea (OSA), compared with White children, unexplained by obesity, and have decreased response to treatment of OSA with adenotonsillectomy, compared with White children. Several studies point in the direction of neighborhood disadvantages as factors in heightened SDB prevalence or severity, Gueye-Ndiaye et al. stated.
The authors performed cross-sectional analyses on data recorded from 303 children (aged 6-12 years) enrolled in the Environmental Assessment of Sleep Youth (EASY) study from 2018 to 2022. Among them, 39% were Hispanic, Latino, Latina, or Spanish origin, 30% were Black or African American, 22% were White, and 11% were other. Maternal education attainment of a high school diploma or less was reported in 27%, and 65% of the sample lived in disadvantaged neighborhoods. Twenty-eight percent of children met criteria for objective SDB (Apnea-Hypopnea Index/Oxygen Desaturation Index ≥ 5/hr). Exposure documentation was informed by caregiver reports, assays of measured settled dust from the child’s bedroom, and neighborhood-level census data from which the Childhood Opportunity Index characterizing neighborhood disadvantage (ND) was derived. The study primary outcome was the SDB-related symptom burden assessed by the OSA-18 questionnaire total score.
Compared with children with no adverse indoor exposures to ETS and pests, children with such exposures had an approximately 4-12 point increase in total OSA-18 scores, and the increase among those with exposure to both ETS and pests was about 20 points (approximately a 1.3 standard deviation increase), Gueye-Ndiaye et al. reported.
In models adjusted for age, sex, minority race, and ethnicity, low maternal education was associated with a 7.55 (95% confidence interval, 3.44-11.66; P < .01) increased OSA-18 score. In models adjusted for sociodemographics including maternal education, history of asthma and allergic rhinitis were associated with a 13.63 (95% CI, 9.44-17.82; P < .01) and a 6.95 (95% CI, 2.62-11.29; P < .02) increased OSA-18 score, respectively. The authors noted that prior Canadian studies have shown OSA to be three times as likely in children with mothers reporting less than a high school education than in children with university educated mothers.
Speculating on the drivers of this association, they noted that the poor air quality due to tobacco smoke and allergen exposures to rodents, mold, and cockroaches are known contributors to asthma symptoms. Despite the differing pathogenesis of OSA and asthma, they suggest overlapping risk factors. Irritants and allergens may exacerbate SDB by stimulating immune responses manifested as adenotonsillar hypertrophy and by amplifying nasopharyngeal inflammation, adversely affecting upper airway patency. While ETS was not common in the sample, it was associated strongly with SDB. Gueye-Ndiaye et al. also showed associations between pest exposure, bedroom dust, and SDB symptoms. The findings, they concluded, support the importance of household- and bedroom-environmental conditions and sleep health.
OSA-18 scores were also elevated by about 7-14 points with allergic rhinitis and asthma, respectively. The findings, Gueye-Ndiaye et al. stated, underscore that asthma prevention strategies can be leveraged to address SDB disparities. No amplification of pest exposure effects, however, was found for asthma or allergic rhinitis.
“This is an incredibly important study, one that adds to our understanding of the risk factors that contribute to pediatric sleep health disparities,” said assistant professor of pediatrics Anne C. Coates, MD, Tufts University, Boston. “We have previously understood risk factors for sleep-disordered breathing like adenotonsillar hypertrophy, but this adds other elements like environmental tobacco smoke, pests, and home and neighborhood factors,” she told this news organization. “One of the most important takeaways is that beyond the importance of accurate diagnosis, there is the importance of advocating for our patients to ensure that they have the healthiest homes and neighborhoods. We need to inspire our colleagues to be advocates – for example – for pest mitigation, for antismoking policies, for every policy preventing the factors that contribute to the burden of disease.”
Dr. Coates is coauthor of “Advocacy and Health Equity: The Role of the Pediatric Pulmonologist,” currently in press (Clinics in Chest Medicine), and a member of the CHEST Physician Editorial Board.
The authors noted that a study limitation was that the sample was from one geographic area (Boston). Neither the authors nor Dr. Coates listed any conflicts.
In the first study evaluating pediatric sleep-disordered breathing (SDB) from both indoor environment and neighborhood perspectives, multilevel risk factors were revealed as being associated with SDB-related symptoms. Beyond known associations with environmental tobacco smoke (ETS), .
Although it has been well known that pediatric SDB affects low socioeconomic status (SES) children disproportionately, the roles of multilevel risk factor drivers including individual health, household SES, indoor exposures to environmental tobacco smoke, pests, and neighborhood characteristics have not been well studied, Gueye-Ndiaye et al. wrote in CHEST Pulmonary.
Pediatric SDB, a known risk factor for many health, neurobehavioral, and functional outcomes, includes habitual snoring and obstructive sleep apnea and may contribute to health disparities. Adenotonsillar hypertrophy and obesity are the most commonly recognized risk factors for SDB in generally healthy school-aged children. A role for other risk factors, however, is suggested by the fact that Black children have a fourfold increased risk for obstructive sleep apnea (OSA), compared with White children, unexplained by obesity, and have decreased response to treatment of OSA with adenotonsillectomy, compared with White children. Several studies point in the direction of neighborhood disadvantages as factors in heightened SDB prevalence or severity, Gueye-Ndiaye et al. stated.
The authors performed cross-sectional analyses on data recorded from 303 children (aged 6-12 years) enrolled in the Environmental Assessment of Sleep Youth (EASY) study from 2018 to 2022. Among them, 39% were Hispanic, Latino, Latina, or Spanish origin, 30% were Black or African American, 22% were White, and 11% were other. Maternal education attainment of a high school diploma or less was reported in 27%, and 65% of the sample lived in disadvantaged neighborhoods. Twenty-eight percent of children met criteria for objective SDB (Apnea-Hypopnea Index/Oxygen Desaturation Index ≥ 5/hr). Exposure documentation was informed by caregiver reports, assays of measured settled dust from the child’s bedroom, and neighborhood-level census data from which the Childhood Opportunity Index characterizing neighborhood disadvantage (ND) was derived. The study primary outcome was the SDB-related symptom burden assessed by the OSA-18 questionnaire total score.
Compared with children with no adverse indoor exposures to ETS and pests, children with such exposures had an approximately 4-12 point increase in total OSA-18 scores, and the increase among those with exposure to both ETS and pests was about 20 points (approximately a 1.3 standard deviation increase), Gueye-Ndiaye et al. reported.
In models adjusted for age, sex, minority race, and ethnicity, low maternal education was associated with a 7.55 (95% confidence interval, 3.44-11.66; P < .01) increased OSA-18 score. In models adjusted for sociodemographics including maternal education, history of asthma and allergic rhinitis were associated with a 13.63 (95% CI, 9.44-17.82; P < .01) and a 6.95 (95% CI, 2.62-11.29; P < .02) increased OSA-18 score, respectively. The authors noted that prior Canadian studies have shown OSA to be three times as likely in children with mothers reporting less than a high school education than in children with university educated mothers.
Speculating on the drivers of this association, they noted that the poor air quality due to tobacco smoke and allergen exposures to rodents, mold, and cockroaches are known contributors to asthma symptoms. Despite the differing pathogenesis of OSA and asthma, they suggest overlapping risk factors. Irritants and allergens may exacerbate SDB by stimulating immune responses manifested as adenotonsillar hypertrophy and by amplifying nasopharyngeal inflammation, adversely affecting upper airway patency. While ETS was not common in the sample, it was associated strongly with SDB. Gueye-Ndiaye et al. also showed associations between pest exposure, bedroom dust, and SDB symptoms. The findings, they concluded, support the importance of household- and bedroom-environmental conditions and sleep health.
OSA-18 scores were also elevated by about 7-14 points with allergic rhinitis and asthma, respectively. The findings, Gueye-Ndiaye et al. stated, underscore that asthma prevention strategies can be leveraged to address SDB disparities. No amplification of pest exposure effects, however, was found for asthma or allergic rhinitis.
“This is an incredibly important study, one that adds to our understanding of the risk factors that contribute to pediatric sleep health disparities,” said assistant professor of pediatrics Anne C. Coates, MD, Tufts University, Boston. “We have previously understood risk factors for sleep-disordered breathing like adenotonsillar hypertrophy, but this adds other elements like environmental tobacco smoke, pests, and home and neighborhood factors,” she told this news organization. “One of the most important takeaways is that beyond the importance of accurate diagnosis, there is the importance of advocating for our patients to ensure that they have the healthiest homes and neighborhoods. We need to inspire our colleagues to be advocates – for example – for pest mitigation, for antismoking policies, for every policy preventing the factors that contribute to the burden of disease.”
Dr. Coates is coauthor of “Advocacy and Health Equity: The Role of the Pediatric Pulmonologist,” currently in press (Clinics in Chest Medicine), and a member of the CHEST Physician Editorial Board.
The authors noted that a study limitation was that the sample was from one geographic area (Boston). Neither the authors nor Dr. Coates listed any conflicts.
FROM CHEST PULMONARY
What the first authorized DNA cancer risk test can and can’t tell you
A novel DNA test system that assesses a person’s genetic predisposition for certain cancers – the first of its kind granted marketing authorization by the Food and Drug Administration – may become a valuable new public health tool.
The Common Hereditary Cancers Panel (Invitae) was approved late September following FDA review under the De Novo process, a regulatory pathway for new types of low- to moderate-risk devices.
Validation of the prescription-only in vitro test was based on assessments of more than 9,000 clinical samples, which demonstrated accuracy of at least 99% for all tested variants in 47 genes known to be associated with an increased risk of developing certain cancers, including breast, ovarian, uterine, prostate, colorectal, gastric, pancreatic as well as melanoma.
How the test system works
Next-generation sequencing assesses germline human genomic DNA extracted from a single blood sample collected at the point of care, such as a doctor’s office, and is sent to a laboratory for analysis.
Specifically, the system aims to detect substitutions, small insertion and deletion alterations, and copy number variants in the panel of 47 targeted genes.
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological health, explained in an FDA press release announcing the marketing authorization.
Clinical interpretation is based on evidence from the published literature, prediction programs, public databases, and Invitae’s own variants database, the FDA statement explained.
What the test can do
Not only can the Common Hereditary Cancer Panel identify genetic variants that increase an individual’s risk of certain cancers, the panel can also help identify potential cancer-related hereditary variants in patients already diagnosed with cancer.
The most clinically significant genes the test system can detect include BRCA1 and BRCA2, which have known associations with hereditary breast and ovarian cancer syndrome; Lynch syndrome–associated genes including MLH1, MSH2, MSH6, PMS2, and EPCAM; CDH1, which is largely associated with hereditary diffuse gastric cancer and lobular breast cancer; and STK11, which is associated with Peutz-Jeghers syndrome.
“Patients should speak with a health care professional, such as a genetic counselor, to discuss any personal/family history of cancer, as such information can be helpful in interpreting test results,” the FDA advised.
What the test can’t do
The test is not intended to identify or evaluate all known genes tied to a person’s potential predisposition for cancer. The test is also not intended for cancer screening or prenatal testing.
For these reasons, and because genetics are not the only factor associated with developing cancer, negative test results could lead to misunderstanding among some patients about their cancer risk.
“Results are intended to be interpreted within the context of additional laboratory results, family history, and clinical findings,” the company wrote in a statement.
Test safety
Risks associated with the test include the possibility of false positive and false negative results and the potential for people to misunderstand what the results mean about their risk for cancer.
A false sense of assurance after a false negative result might, for instance, lead patients to forgo recommended surveillance or clinical management, whereas false positive test results could lead to inappropriate decision-making and undesirable consequences.
“These risks are mitigated by the analytical performance validation, clinical validation, and appropriate labeling of this test,” the agency explained.
Along with the De Novo authorization, the FDA is establishing special controls to define requirements for these tests. For instance, accuracy must be 99% or higher for positive agreement and at least 99.9% for negative agreement with a validated, independent method.
Public health implications
The information gleaned from this tool can “help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants,” Dr. Shuren said.
The marketing authorization of Invitae’s test established a new regulatory category, which “means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process,” the FDA explained.
A version of this article first appeared on Medscape.com.
A novel DNA test system that assesses a person’s genetic predisposition for certain cancers – the first of its kind granted marketing authorization by the Food and Drug Administration – may become a valuable new public health tool.
The Common Hereditary Cancers Panel (Invitae) was approved late September following FDA review under the De Novo process, a regulatory pathway for new types of low- to moderate-risk devices.
Validation of the prescription-only in vitro test was based on assessments of more than 9,000 clinical samples, which demonstrated accuracy of at least 99% for all tested variants in 47 genes known to be associated with an increased risk of developing certain cancers, including breast, ovarian, uterine, prostate, colorectal, gastric, pancreatic as well as melanoma.
How the test system works
Next-generation sequencing assesses germline human genomic DNA extracted from a single blood sample collected at the point of care, such as a doctor’s office, and is sent to a laboratory for analysis.
Specifically, the system aims to detect substitutions, small insertion and deletion alterations, and copy number variants in the panel of 47 targeted genes.
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological health, explained in an FDA press release announcing the marketing authorization.
Clinical interpretation is based on evidence from the published literature, prediction programs, public databases, and Invitae’s own variants database, the FDA statement explained.
What the test can do
Not only can the Common Hereditary Cancer Panel identify genetic variants that increase an individual’s risk of certain cancers, the panel can also help identify potential cancer-related hereditary variants in patients already diagnosed with cancer.
The most clinically significant genes the test system can detect include BRCA1 and BRCA2, which have known associations with hereditary breast and ovarian cancer syndrome; Lynch syndrome–associated genes including MLH1, MSH2, MSH6, PMS2, and EPCAM; CDH1, which is largely associated with hereditary diffuse gastric cancer and lobular breast cancer; and STK11, which is associated with Peutz-Jeghers syndrome.
“Patients should speak with a health care professional, such as a genetic counselor, to discuss any personal/family history of cancer, as such information can be helpful in interpreting test results,” the FDA advised.
What the test can’t do
The test is not intended to identify or evaluate all known genes tied to a person’s potential predisposition for cancer. The test is also not intended for cancer screening or prenatal testing.
For these reasons, and because genetics are not the only factor associated with developing cancer, negative test results could lead to misunderstanding among some patients about their cancer risk.
“Results are intended to be interpreted within the context of additional laboratory results, family history, and clinical findings,” the company wrote in a statement.
Test safety
Risks associated with the test include the possibility of false positive and false negative results and the potential for people to misunderstand what the results mean about their risk for cancer.
A false sense of assurance after a false negative result might, for instance, lead patients to forgo recommended surveillance or clinical management, whereas false positive test results could lead to inappropriate decision-making and undesirable consequences.
“These risks are mitigated by the analytical performance validation, clinical validation, and appropriate labeling of this test,” the agency explained.
Along with the De Novo authorization, the FDA is establishing special controls to define requirements for these tests. For instance, accuracy must be 99% or higher for positive agreement and at least 99.9% for negative agreement with a validated, independent method.
Public health implications
The information gleaned from this tool can “help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants,” Dr. Shuren said.
The marketing authorization of Invitae’s test established a new regulatory category, which “means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process,” the FDA explained.
A version of this article first appeared on Medscape.com.
A novel DNA test system that assesses a person’s genetic predisposition for certain cancers – the first of its kind granted marketing authorization by the Food and Drug Administration – may become a valuable new public health tool.
The Common Hereditary Cancers Panel (Invitae) was approved late September following FDA review under the De Novo process, a regulatory pathway for new types of low- to moderate-risk devices.
Validation of the prescription-only in vitro test was based on assessments of more than 9,000 clinical samples, which demonstrated accuracy of at least 99% for all tested variants in 47 genes known to be associated with an increased risk of developing certain cancers, including breast, ovarian, uterine, prostate, colorectal, gastric, pancreatic as well as melanoma.
How the test system works
Next-generation sequencing assesses germline human genomic DNA extracted from a single blood sample collected at the point of care, such as a doctor’s office, and is sent to a laboratory for analysis.
Specifically, the system aims to detect substitutions, small insertion and deletion alterations, and copy number variants in the panel of 47 targeted genes.
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological health, explained in an FDA press release announcing the marketing authorization.
Clinical interpretation is based on evidence from the published literature, prediction programs, public databases, and Invitae’s own variants database, the FDA statement explained.
What the test can do
Not only can the Common Hereditary Cancer Panel identify genetic variants that increase an individual’s risk of certain cancers, the panel can also help identify potential cancer-related hereditary variants in patients already diagnosed with cancer.
The most clinically significant genes the test system can detect include BRCA1 and BRCA2, which have known associations with hereditary breast and ovarian cancer syndrome; Lynch syndrome–associated genes including MLH1, MSH2, MSH6, PMS2, and EPCAM; CDH1, which is largely associated with hereditary diffuse gastric cancer and lobular breast cancer; and STK11, which is associated with Peutz-Jeghers syndrome.
“Patients should speak with a health care professional, such as a genetic counselor, to discuss any personal/family history of cancer, as such information can be helpful in interpreting test results,” the FDA advised.
What the test can’t do
The test is not intended to identify or evaluate all known genes tied to a person’s potential predisposition for cancer. The test is also not intended for cancer screening or prenatal testing.
For these reasons, and because genetics are not the only factor associated with developing cancer, negative test results could lead to misunderstanding among some patients about their cancer risk.
“Results are intended to be interpreted within the context of additional laboratory results, family history, and clinical findings,” the company wrote in a statement.
Test safety
Risks associated with the test include the possibility of false positive and false negative results and the potential for people to misunderstand what the results mean about their risk for cancer.
A false sense of assurance after a false negative result might, for instance, lead patients to forgo recommended surveillance or clinical management, whereas false positive test results could lead to inappropriate decision-making and undesirable consequences.
“These risks are mitigated by the analytical performance validation, clinical validation, and appropriate labeling of this test,” the agency explained.
Along with the De Novo authorization, the FDA is establishing special controls to define requirements for these tests. For instance, accuracy must be 99% or higher for positive agreement and at least 99.9% for negative agreement with a validated, independent method.
Public health implications
The information gleaned from this tool can “help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants,” Dr. Shuren said.
The marketing authorization of Invitae’s test established a new regulatory category, which “means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process,” the FDA explained.
A version of this article first appeared on Medscape.com.
SCLC Pathophysiology & Epidemiology
Pruritic rash and nocturnal itching
A 62-YEAR-OLD HISPANIC WOMAN with a history of well-controlled diabetes and hypertension presented with an intensely pruritic rash of 3 months’ duration. She reported poor sleep due to scratching throughout the night. She denied close contact with individuals with similar rashes or itching, new intimate partners, or recent travel. She worked in an office setting and had stable, noncrowded housing.
A physical exam revealed brown and purple scaly papules and many excoriation marks. The rash was concentrated along clothing lines, around intertriginous areas, and on her ankles, wrists, and the interdigital spaces (FIGURE 1A and 1B).
WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?
Diagnosis: Scabies
Scabies is a diagnosis that should be considered in any patient with new-onset, widespread, nocturnal-dominant pruritus1 and it was suspected, in this case, after the initial history taking and physical exam. (See “Consider these diagnoses in cases of pruritic skin conditions” for more on lichen planus and prurigo nodularis, which were also included in the differential diagnosis.)
SIDEBAR
Consider these diagnoses in cases of pruritic skin conditions
Lichen planus is a chronic inflammatory condition that mostly affects the skin and mucosa. Characteristic findings are groups of shiny, flat-topped, firm papules. This patient’s widespread nodular lesions with rough scales were not typical of lichen planus, which usually manifests with flat (hence the name “planus”) and shiny lesions.
Prurigo nodularis is a chronic condition that manifests as intensely itchy, firm papules. The lesions can appear anywhere on the body, but more commonly are found on the extremities, back, and torso. The recent manifestation of the patient’s lesions and her lack of a history of chronic dermatitis argued against this diagnosis.
The use of a handheld dermatoscope confirmed the diagnosis by revealing white to yellow scales following the serpiginous lines. These serpiginous lines resembled scabies burrows, and at the end of some burrows, small triangular and hyperpigmented structures resembling “delta-winged jets” were seen. These “delta-winged jets” were the mite’s pigmented mouth parts and anterior legs. The burrows, which contain eggs and feces, have been described as the “contrails” behind the jets (FIGURE 2).
The use of a new UV illumination feature on our dermatoscope (which we’ll describe shortly) made for an even more dramatic diagnostic visual. With the click of a button, the mites fluoresced green to yellow and the burrows fluoresced white to blue (FIGURE 3).
Meeting the criteria. The clinical and dermoscopic findings met the 2020 International Alliance for the Control of Scabies (IACS) Consensus Criteria for the Diagnosis of Scabies,2 confirming the diagnosis in this patient. Scabies infestation poses a significant public health burden globally, with an estimated incidence of more than 454 million in 2016.3
Visualization is key to the diagnosis
Traditionally, the diagnosis of scabies infestation is made by direct visualization of mites via microscopy of skin scrapings.4 However, this approach is seldom feasible in a family medicine office. Fortunately, the 2020 IACS criteria included dermoscopy as a Level A diagnostic method for confirmed scabies.
Continue to: The pros and cons of dermoscopy
The pros and cons of dermoscopy. A handheld dermatoscope is an accessible, convenient tool for any clinician who treats the skin. It has been demonstrated that, in the hands of experts and novices alike, dermoscopy has a sensitivity of 91% and specificity of 86% for the diagnosis of scabies.5
However, accurate identification of the dermoscopic findings can depend on the operator and can be harder to achieve in patients who have skin of color.2 This is largely because the mite’s brown-to-black triangular head is small (sometimes hidden under skin scales) and easy to miss, especially against darker skin.
A new technologic feature helps. In this case, we used the built-in 365-nm UV illumination feature of our handheld dermatoscope (Dermlite-5) and both mites and burrows fluoresced intensely (FIGURE 3). A skin scraping at the location of the fluorescent body under microscopic examination confirmed that the organism was a Sarcoptes scabiei mite (FIGURE 4).
UV light dermoscopy can decrease operator error and ameliorate the challenge of diagnosing scabies in skin of color. Specifically, when using UV dermoscopy it’s easier to:
- locate mites, regardless of the patient’s skin color
- see the mite’s entire body, rather than just a small portion (thus increasing diagnostic certainty).
New diagnostic feature, classic treatment
Due to the severity of the patient’s scabies, she was prescribed both permethrin 5% cream and oral ivermectin 200 mcg/kg, both to be used immediately and repeated in 1 week. Notably, a systematic review indicated that topical permethrin is a superior treatment to oral ivermectin.6 However, in cases of widespread scabies and crusted scabies, it is standard of care to treat with both medications.
The patient’s pruritus was treated with cetirizine as needed. She was told that the itching might persist for a few weeks after treatment was completed.
Reinfestation was a concern with this patient because she was unable to identify a source for the mites. To minimize the likelihood of reinfestation, we advised her to decontaminate her bedding, clothing, and towels by washing them in hot water (≥ 122° F) or placing in a sealed plastic bag for at least 1 week.1 For crusted scabies cases, thorough vacuuming of a patient’s furniture and carpets is recommended.
1. Gunning K, Kiraly B, Pippitt K. Lice and scabies: treatment update. Am Fam Physician. 2019;99:635-642.
2. Engelman D, Yoshizumi J, Hay RJ, et al. The 2020 International Alliance for the Control of Scabies Consensus Criteria for the Diagnosis of Scabies. Br J Dermatol. 2020;183:808-820. doi: 10.1111/bjd.18943
A 62-YEAR-OLD HISPANIC WOMAN with a history of well-controlled diabetes and hypertension presented with an intensely pruritic rash of 3 months’ duration. She reported poor sleep due to scratching throughout the night. She denied close contact with individuals with similar rashes or itching, new intimate partners, or recent travel. She worked in an office setting and had stable, noncrowded housing.
A physical exam revealed brown and purple scaly papules and many excoriation marks. The rash was concentrated along clothing lines, around intertriginous areas, and on her ankles, wrists, and the interdigital spaces (FIGURE 1A and 1B).
WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?
Diagnosis: Scabies
Scabies is a diagnosis that should be considered in any patient with new-onset, widespread, nocturnal-dominant pruritus1 and it was suspected, in this case, after the initial history taking and physical exam. (See “Consider these diagnoses in cases of pruritic skin conditions” for more on lichen planus and prurigo nodularis, which were also included in the differential diagnosis.)
SIDEBAR
Consider these diagnoses in cases of pruritic skin conditions
Lichen planus is a chronic inflammatory condition that mostly affects the skin and mucosa. Characteristic findings are groups of shiny, flat-topped, firm papules. This patient’s widespread nodular lesions with rough scales were not typical of lichen planus, which usually manifests with flat (hence the name “planus”) and shiny lesions.
Prurigo nodularis is a chronic condition that manifests as intensely itchy, firm papules. The lesions can appear anywhere on the body, but more commonly are found on the extremities, back, and torso. The recent manifestation of the patient’s lesions and her lack of a history of chronic dermatitis argued against this diagnosis.
The use of a handheld dermatoscope confirmed the diagnosis by revealing white to yellow scales following the serpiginous lines. These serpiginous lines resembled scabies burrows, and at the end of some burrows, small triangular and hyperpigmented structures resembling “delta-winged jets” were seen. These “delta-winged jets” were the mite’s pigmented mouth parts and anterior legs. The burrows, which contain eggs and feces, have been described as the “contrails” behind the jets (FIGURE 2).
The use of a new UV illumination feature on our dermatoscope (which we’ll describe shortly) made for an even more dramatic diagnostic visual. With the click of a button, the mites fluoresced green to yellow and the burrows fluoresced white to blue (FIGURE 3).
Meeting the criteria. The clinical and dermoscopic findings met the 2020 International Alliance for the Control of Scabies (IACS) Consensus Criteria for the Diagnosis of Scabies,2 confirming the diagnosis in this patient. Scabies infestation poses a significant public health burden globally, with an estimated incidence of more than 454 million in 2016.3
Visualization is key to the diagnosis
Traditionally, the diagnosis of scabies infestation is made by direct visualization of mites via microscopy of skin scrapings.4 However, this approach is seldom feasible in a family medicine office. Fortunately, the 2020 IACS criteria included dermoscopy as a Level A diagnostic method for confirmed scabies.
Continue to: The pros and cons of dermoscopy
The pros and cons of dermoscopy. A handheld dermatoscope is an accessible, convenient tool for any clinician who treats the skin. It has been demonstrated that, in the hands of experts and novices alike, dermoscopy has a sensitivity of 91% and specificity of 86% for the diagnosis of scabies.5
However, accurate identification of the dermoscopic findings can depend on the operator and can be harder to achieve in patients who have skin of color.2 This is largely because the mite’s brown-to-black triangular head is small (sometimes hidden under skin scales) and easy to miss, especially against darker skin.
A new technologic feature helps. In this case, we used the built-in 365-nm UV illumination feature of our handheld dermatoscope (Dermlite-5) and both mites and burrows fluoresced intensely (FIGURE 3). A skin scraping at the location of the fluorescent body under microscopic examination confirmed that the organism was a Sarcoptes scabiei mite (FIGURE 4).
UV light dermoscopy can decrease operator error and ameliorate the challenge of diagnosing scabies in skin of color. Specifically, when using UV dermoscopy it’s easier to:
- locate mites, regardless of the patient’s skin color
- see the mite’s entire body, rather than just a small portion (thus increasing diagnostic certainty).
New diagnostic feature, classic treatment
Due to the severity of the patient’s scabies, she was prescribed both permethrin 5% cream and oral ivermectin 200 mcg/kg, both to be used immediately and repeated in 1 week. Notably, a systematic review indicated that topical permethrin is a superior treatment to oral ivermectin.6 However, in cases of widespread scabies and crusted scabies, it is standard of care to treat with both medications.
The patient’s pruritus was treated with cetirizine as needed. She was told that the itching might persist for a few weeks after treatment was completed.
Reinfestation was a concern with this patient because she was unable to identify a source for the mites. To minimize the likelihood of reinfestation, we advised her to decontaminate her bedding, clothing, and towels by washing them in hot water (≥ 122° F) or placing in a sealed plastic bag for at least 1 week.1 For crusted scabies cases, thorough vacuuming of a patient’s furniture and carpets is recommended.
A 62-YEAR-OLD HISPANIC WOMAN with a history of well-controlled diabetes and hypertension presented with an intensely pruritic rash of 3 months’ duration. She reported poor sleep due to scratching throughout the night. She denied close contact with individuals with similar rashes or itching, new intimate partners, or recent travel. She worked in an office setting and had stable, noncrowded housing.
A physical exam revealed brown and purple scaly papules and many excoriation marks. The rash was concentrated along clothing lines, around intertriginous areas, and on her ankles, wrists, and the interdigital spaces (FIGURE 1A and 1B).
WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?
Diagnosis: Scabies
Scabies is a diagnosis that should be considered in any patient with new-onset, widespread, nocturnal-dominant pruritus1 and it was suspected, in this case, after the initial history taking and physical exam. (See “Consider these diagnoses in cases of pruritic skin conditions” for more on lichen planus and prurigo nodularis, which were also included in the differential diagnosis.)
SIDEBAR
Consider these diagnoses in cases of pruritic skin conditions
Lichen planus is a chronic inflammatory condition that mostly affects the skin and mucosa. Characteristic findings are groups of shiny, flat-topped, firm papules. This patient’s widespread nodular lesions with rough scales were not typical of lichen planus, which usually manifests with flat (hence the name “planus”) and shiny lesions.
Prurigo nodularis is a chronic condition that manifests as intensely itchy, firm papules. The lesions can appear anywhere on the body, but more commonly are found on the extremities, back, and torso. The recent manifestation of the patient’s lesions and her lack of a history of chronic dermatitis argued against this diagnosis.
The use of a handheld dermatoscope confirmed the diagnosis by revealing white to yellow scales following the serpiginous lines. These serpiginous lines resembled scabies burrows, and at the end of some burrows, small triangular and hyperpigmented structures resembling “delta-winged jets” were seen. These “delta-winged jets” were the mite’s pigmented mouth parts and anterior legs. The burrows, which contain eggs and feces, have been described as the “contrails” behind the jets (FIGURE 2).
The use of a new UV illumination feature on our dermatoscope (which we’ll describe shortly) made for an even more dramatic diagnostic visual. With the click of a button, the mites fluoresced green to yellow and the burrows fluoresced white to blue (FIGURE 3).
Meeting the criteria. The clinical and dermoscopic findings met the 2020 International Alliance for the Control of Scabies (IACS) Consensus Criteria for the Diagnosis of Scabies,2 confirming the diagnosis in this patient. Scabies infestation poses a significant public health burden globally, with an estimated incidence of more than 454 million in 2016.3
Visualization is key to the diagnosis
Traditionally, the diagnosis of scabies infestation is made by direct visualization of mites via microscopy of skin scrapings.4 However, this approach is seldom feasible in a family medicine office. Fortunately, the 2020 IACS criteria included dermoscopy as a Level A diagnostic method for confirmed scabies.
Continue to: The pros and cons of dermoscopy
The pros and cons of dermoscopy. A handheld dermatoscope is an accessible, convenient tool for any clinician who treats the skin. It has been demonstrated that, in the hands of experts and novices alike, dermoscopy has a sensitivity of 91% and specificity of 86% for the diagnosis of scabies.5
However, accurate identification of the dermoscopic findings can depend on the operator and can be harder to achieve in patients who have skin of color.2 This is largely because the mite’s brown-to-black triangular head is small (sometimes hidden under skin scales) and easy to miss, especially against darker skin.
A new technologic feature helps. In this case, we used the built-in 365-nm UV illumination feature of our handheld dermatoscope (Dermlite-5) and both mites and burrows fluoresced intensely (FIGURE 3). A skin scraping at the location of the fluorescent body under microscopic examination confirmed that the organism was a Sarcoptes scabiei mite (FIGURE 4).
UV light dermoscopy can decrease operator error and ameliorate the challenge of diagnosing scabies in skin of color. Specifically, when using UV dermoscopy it’s easier to:
- locate mites, regardless of the patient’s skin color
- see the mite’s entire body, rather than just a small portion (thus increasing diagnostic certainty).
New diagnostic feature, classic treatment
Due to the severity of the patient’s scabies, she was prescribed both permethrin 5% cream and oral ivermectin 200 mcg/kg, both to be used immediately and repeated in 1 week. Notably, a systematic review indicated that topical permethrin is a superior treatment to oral ivermectin.6 However, in cases of widespread scabies and crusted scabies, it is standard of care to treat with both medications.
The patient’s pruritus was treated with cetirizine as needed. She was told that the itching might persist for a few weeks after treatment was completed.
Reinfestation was a concern with this patient because she was unable to identify a source for the mites. To minimize the likelihood of reinfestation, we advised her to decontaminate her bedding, clothing, and towels by washing them in hot water (≥ 122° F) or placing in a sealed plastic bag for at least 1 week.1 For crusted scabies cases, thorough vacuuming of a patient’s furniture and carpets is recommended.
1. Gunning K, Kiraly B, Pippitt K. Lice and scabies: treatment update. Am Fam Physician. 2019;99:635-642.
2. Engelman D, Yoshizumi J, Hay RJ, et al. The 2020 International Alliance for the Control of Scabies Consensus Criteria for the Diagnosis of Scabies. Br J Dermatol. 2020;183:808-820. doi: 10.1111/bjd.18943
1. Gunning K, Kiraly B, Pippitt K. Lice and scabies: treatment update. Am Fam Physician. 2019;99:635-642.
2. Engelman D, Yoshizumi J, Hay RJ, et al. The 2020 International Alliance for the Control of Scabies Consensus Criteria for the Diagnosis of Scabies. Br J Dermatol. 2020;183:808-820. doi: 10.1111/bjd.18943
Are manual therapies effective at reducing chronic tension headache frequency in adults?
Evidence summary
Small studies offer mixed evidence of benefit
Seven RCTs using manual therapies to treat chronic tension headaches have reported the change in headache frequency (TABLE1-7). Most, but not all, manual therapies significantly improved headache frequency.
Participants ranged in age from 18 to 65 years, with mean age ranges of 33 to 42 years in each study. At baseline, patients had 10 or more tension-type headaches per month. The manual therapies varied in techniques, duration, and the training of the person performing the intervention:
- Twice-weekly chiropractic spinal manipulation for 6 weeks1
- Soft-tissue therapy plus spinal manipulation (8 treatments over 4 weeks)2
- Chiropractic spinal manipulation with or without amitriptyline for 14 weeks3
- Corrective osteopathic manipulation treatment (OMT) techniques tailored for each patient for 1 month4
- High-velocity low-amplitude manipulation (HVLA) plus exercise or myofascial release plus exercise twice weekly for 8 weeks5
- Manual therapy treatment consisting of a combination of mobilizations of the cervical and thoracic spine, exercises, and postural correction for up to 9 sessions of 30 minutes each6
- One hour of direct or indirect myofascial release treatment twice weekly for 12 weeks.7
Three studies involved chiropractic providers.1-3 One study (n = 19) found a positive effect, in which chiropractic manipulation augmented with amitriptyline performed better than chiropractic manipulation alone.3 Another chiropractic study did not find an immediate posttreatment benefit but did report significant headache reduction at the 4-week follow-up interval.1 The third chiropractic study did not show additional benefit from HVLA manipulation.2
One small study involving osteopathic physicians using OMT found reduced headache frequency after 12 weeks but not at 4 weeks.4 Another study, comparing HVLA or myofascial release with exercise to exercise alone, found benefit for the HVLA group but not for myofascial release; interventions in this study were performed by a physician with at least 6 years of unspecified manual therapy experience.5 A small study of manual therapists found improvement at the end of manual therapy but not at 18 months.6 Another small study using providers with 10 months’ experience with myofascial release found reduced headache frequency 4 weeks after a course of direct and indirect myofascial release (compared with sham release).7
Editor’s takeaway
It isn’t hard to imagine why muscle tension headaches might respond to certain forms of manual therapy. However, all available studies of these modalities have been small (< 100 patients) or lacked blinding, introducing the potential for significant bias. Nevertheless, for now it appears reasonable to refer interested patients with tension headache to an osteopathic physician for OMT or myofascial release to reduce headache frequency.
1. Boline PD, Kassak K, Bronfort G, et al. Spinal manipulation vs amitriptyline for the treatment of chronic tension-type headaches—a randomized clinical-trial. J Manipulative Physiol Ther. 1995;18:148-254.
2. Bove G. Spinal manipulation in the treatment of episodic tension-type headache: a randomized controlled trial. JAMA. 1998;280:1576-1579.
3. Vernon H, Jansz G, Goldsmith CH, et al. A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial. J Manipulative Physiol Ther. 2009;32:344-351.
4. Rolle G, Tremolizzo L, Somalvico F, et al. Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. J Am Osteopath Assoc. 2014;114:678-685. doi: 10.7556/jaoa.2014.136
5. Corum M, Aydin T, Ceylan CM, et al. The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: a randomized controlled trial. Complement Ther Clin Pract. 2021;43:101319. doi: 0.1016/j.ctcp.2021.101319
6. Castien RF, van der Windt DAWM, Grooten A, et al. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2009;31:133-143.
7. Ajimsha MS. Effectiveness of direct vs indirect technique myofascial release in the management of tension-type headache. J Bodyw Mov Ther. 2011;15:431-435. doi: 10.1016/j.jbmt.2011.01.021
Evidence summary
Small studies offer mixed evidence of benefit
Seven RCTs using manual therapies to treat chronic tension headaches have reported the change in headache frequency (TABLE1-7). Most, but not all, manual therapies significantly improved headache frequency.
Participants ranged in age from 18 to 65 years, with mean age ranges of 33 to 42 years in each study. At baseline, patients had 10 or more tension-type headaches per month. The manual therapies varied in techniques, duration, and the training of the person performing the intervention:
- Twice-weekly chiropractic spinal manipulation for 6 weeks1
- Soft-tissue therapy plus spinal manipulation (8 treatments over 4 weeks)2
- Chiropractic spinal manipulation with or without amitriptyline for 14 weeks3
- Corrective osteopathic manipulation treatment (OMT) techniques tailored for each patient for 1 month4
- High-velocity low-amplitude manipulation (HVLA) plus exercise or myofascial release plus exercise twice weekly for 8 weeks5
- Manual therapy treatment consisting of a combination of mobilizations of the cervical and thoracic spine, exercises, and postural correction for up to 9 sessions of 30 minutes each6
- One hour of direct or indirect myofascial release treatment twice weekly for 12 weeks.7
Three studies involved chiropractic providers.1-3 One study (n = 19) found a positive effect, in which chiropractic manipulation augmented with amitriptyline performed better than chiropractic manipulation alone.3 Another chiropractic study did not find an immediate posttreatment benefit but did report significant headache reduction at the 4-week follow-up interval.1 The third chiropractic study did not show additional benefit from HVLA manipulation.2
One small study involving osteopathic physicians using OMT found reduced headache frequency after 12 weeks but not at 4 weeks.4 Another study, comparing HVLA or myofascial release with exercise to exercise alone, found benefit for the HVLA group but not for myofascial release; interventions in this study were performed by a physician with at least 6 years of unspecified manual therapy experience.5 A small study of manual therapists found improvement at the end of manual therapy but not at 18 months.6 Another small study using providers with 10 months’ experience with myofascial release found reduced headache frequency 4 weeks after a course of direct and indirect myofascial release (compared with sham release).7
Editor’s takeaway
It isn’t hard to imagine why muscle tension headaches might respond to certain forms of manual therapy. However, all available studies of these modalities have been small (< 100 patients) or lacked blinding, introducing the potential for significant bias. Nevertheless, for now it appears reasonable to refer interested patients with tension headache to an osteopathic physician for OMT or myofascial release to reduce headache frequency.
Evidence summary
Small studies offer mixed evidence of benefit
Seven RCTs using manual therapies to treat chronic tension headaches have reported the change in headache frequency (TABLE1-7). Most, but not all, manual therapies significantly improved headache frequency.
Participants ranged in age from 18 to 65 years, with mean age ranges of 33 to 42 years in each study. At baseline, patients had 10 or more tension-type headaches per month. The manual therapies varied in techniques, duration, and the training of the person performing the intervention:
- Twice-weekly chiropractic spinal manipulation for 6 weeks1
- Soft-tissue therapy plus spinal manipulation (8 treatments over 4 weeks)2
- Chiropractic spinal manipulation with or without amitriptyline for 14 weeks3
- Corrective osteopathic manipulation treatment (OMT) techniques tailored for each patient for 1 month4
- High-velocity low-amplitude manipulation (HVLA) plus exercise or myofascial release plus exercise twice weekly for 8 weeks5
- Manual therapy treatment consisting of a combination of mobilizations of the cervical and thoracic spine, exercises, and postural correction for up to 9 sessions of 30 minutes each6
- One hour of direct or indirect myofascial release treatment twice weekly for 12 weeks.7
Three studies involved chiropractic providers.1-3 One study (n = 19) found a positive effect, in which chiropractic manipulation augmented with amitriptyline performed better than chiropractic manipulation alone.3 Another chiropractic study did not find an immediate posttreatment benefit but did report significant headache reduction at the 4-week follow-up interval.1 The third chiropractic study did not show additional benefit from HVLA manipulation.2
One small study involving osteopathic physicians using OMT found reduced headache frequency after 12 weeks but not at 4 weeks.4 Another study, comparing HVLA or myofascial release with exercise to exercise alone, found benefit for the HVLA group but not for myofascial release; interventions in this study were performed by a physician with at least 6 years of unspecified manual therapy experience.5 A small study of manual therapists found improvement at the end of manual therapy but not at 18 months.6 Another small study using providers with 10 months’ experience with myofascial release found reduced headache frequency 4 weeks after a course of direct and indirect myofascial release (compared with sham release).7
Editor’s takeaway
It isn’t hard to imagine why muscle tension headaches might respond to certain forms of manual therapy. However, all available studies of these modalities have been small (< 100 patients) or lacked blinding, introducing the potential for significant bias. Nevertheless, for now it appears reasonable to refer interested patients with tension headache to an osteopathic physician for OMT or myofascial release to reduce headache frequency.
1. Boline PD, Kassak K, Bronfort G, et al. Spinal manipulation vs amitriptyline for the treatment of chronic tension-type headaches—a randomized clinical-trial. J Manipulative Physiol Ther. 1995;18:148-254.
2. Bove G. Spinal manipulation in the treatment of episodic tension-type headache: a randomized controlled trial. JAMA. 1998;280:1576-1579.
3. Vernon H, Jansz G, Goldsmith CH, et al. A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial. J Manipulative Physiol Ther. 2009;32:344-351.
4. Rolle G, Tremolizzo L, Somalvico F, et al. Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. J Am Osteopath Assoc. 2014;114:678-685. doi: 10.7556/jaoa.2014.136
5. Corum M, Aydin T, Ceylan CM, et al. The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: a randomized controlled trial. Complement Ther Clin Pract. 2021;43:101319. doi: 0.1016/j.ctcp.2021.101319
6. Castien RF, van der Windt DAWM, Grooten A, et al. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2009;31:133-143.
7. Ajimsha MS. Effectiveness of direct vs indirect technique myofascial release in the management of tension-type headache. J Bodyw Mov Ther. 2011;15:431-435. doi: 10.1016/j.jbmt.2011.01.021
1. Boline PD, Kassak K, Bronfort G, et al. Spinal manipulation vs amitriptyline for the treatment of chronic tension-type headaches—a randomized clinical-trial. J Manipulative Physiol Ther. 1995;18:148-254.
2. Bove G. Spinal manipulation in the treatment of episodic tension-type headache: a randomized controlled trial. JAMA. 1998;280:1576-1579.
3. Vernon H, Jansz G, Goldsmith CH, et al. A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial. J Manipulative Physiol Ther. 2009;32:344-351.
4. Rolle G, Tremolizzo L, Somalvico F, et al. Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. J Am Osteopath Assoc. 2014;114:678-685. doi: 10.7556/jaoa.2014.136
5. Corum M, Aydin T, Ceylan CM, et al. The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: a randomized controlled trial. Complement Ther Clin Pract. 2021;43:101319. doi: 0.1016/j.ctcp.2021.101319
6. Castien RF, van der Windt DAWM, Grooten A, et al. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2009;31:133-143.
7. Ajimsha MS. Effectiveness of direct vs indirect technique myofascial release in the management of tension-type headache. J Bodyw Mov Ther. 2011;15:431-435. doi: 10.1016/j.jbmt.2011.01.021
EVIDENCE-BASED ANSWER:
MAYBE. Among patients with chronic tension headaches, manual therapies may reduce headache frequency more than sham manual therapy, usual care, or exercise treatments—by 1.5 to 4.2 headaches or days with headache per week (strength of recommendation, B; preponderance of evidence from primarily small, heterogeneous randomized controlled trials [RCTs]).
