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New cardiology certification board: What’s the plan?
The proposal by the major cardiovascular societies in the US to form a new board of cardiovascular medicine to manage initial and ongoing certification of cardiologists represents something of a revolution in the field of continuing medical education and assessment of competency.
Five US cardiovascular societies — the American College of Cardiology (ACC), the American Heart Association (AHA), the Heart Failure Society of America (HFSA), the Heart Rhythm Society (HRS), and the Society for Cardiovascular Angiography & Interventions (SCAI) — have now joined forces to propose a new professional certification board for cardiovascular medicine, to be known as the American Board of Cardiovascular Medicine (ABCVM).
The ABCVM would be independent of the American Board of Internal Medicine (ABIM), the current organization providing maintenance of certification for cardiologists as well as many other internal medicine subspecialties. The ABIM’s maintenance of certification process has been widely criticized for many years and has been described as “needlessly burdensome and expensive.”
, according to Jeffrey Kuvin, MD, a trustee of the ACC, who has been heading up the working group to develop this plan.
Dr. Kuvin, who is chair of the cardiology at Northwell Health, Manhasset, New York, a large academic healthcare system, explained that maintenance of certification has been a topic of discussion across the cardiovascular community for many years, and the ACC has a working group focused on the next steps for evaluation of competency, which he chairs.
“The topic of evaluation of competence has been on the mind of the ACC for many years and hence a work group was developed to focus on this,” Dr. Kuvin noted. “A lot of evolution of the concepts and next steps have been drawn out of this working group. And now other cardiovascular societies have joined to show unification across the house of cardiology and that this is indeed the way that the cardiovascular profession should move.”
“Time to Separate from Internal Medicine”
The general concept behind the new cardiology board is to separate cardiology from the ABIM.
“This is rooted from the concept that cardiology has evolved so much over the last few decades into such a large multidimensional specialty that it really does demarcate itself from internal medicine, and as such, it deserves a separate board governed by cardiologists with collaboration across the entirely of cardiology,” Dr. Kuvin said.
Cardiology has had significant growth and expansion of technology, tools, medications, and the approach to patients in many specialities and subspecialties, he added. “We have defined training programs in many different areas within cardiology; we have our own guidelines, our own competency statements, and in many cases, cardiology exists as its own department outside of medicine in many institutions. It’s just time to separate cardiology from the umbrella of internal medicine.”
The new cardiology board would be separate from, and not report to, the ABIM; rather, it would report directly to the American Board of Medical Specialties (ABMS), the only recognized medical certification body in the US.
What Are the Proposed Changes
Under the present system, managed by the ABIM, clinicians must undergo two stages of certification to be a cardiologist. First, they have to pass the initial certification exam in general cardiology, and then exams in one of four subspecialties if they plan to enter one of these, including interventional cardiology, electrophysiology, advanced heart failure or adult congenital heart disease.
Next, clinicians enter the maintenance of certification phase, which can take three different forms: 1) taking another recertification exam every 10 years; 2) the collaborative maintenance pathway — a collaboration between ACC and ABIM, which includes evaluation, learning and a certified exam each year; or 3) longitudinal knowledge and assessment — in which the program interacts with the clinician on an ongoing basis, sending secured questions regularly.
All three of these pathways for maintenance of certification involve high stakes questions and a set bar for passing or failing.
Under the proposed new cardiology board, an initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured, with the new approach taking the form of continuous learning and assessment of competency.
“This is an iterative process, but we envision with a new American Board of Cardiovascular Medicine, we will pick up where the ABIM left off,” Dr. Kuvin notes. “That includes an initial certifying examination for the five areas that already exist under the ABIM system but with the opportunities to expand that to further specialties as well.”
He points out that there are several areas in cardiology that are currently not represented by these five areas that warrant some discussion, including multimodality imaging, vascular heart disease, and cardio-oncology.
“At present, everybody has to pass the general cardiology exam and then some may wish to further train and get certified in one of the other four other specific areas. But one topic that has been discussed over many years is how do we maintain competency in the areas in which clinicians practice over their lifetime as a cardiologist,” Dr. Kuvin commented.
He said the proposed cardiology board would like to adhere to some basic principles that are fundamental to the practice of medicine.
“We want to make sure that we are practicing medicine so that our patients derive the most benefit from seeing a cardiologist,” he said. “We also want to make sure, however, that this is a supportive process, supporting cardiologists to learn what they know and more importantly what they don’t know; to identify knowledge gaps in specific area; to help the cardiologist fill those knowledge gaps; to acknowledge those gaps have been filled; and then move on to another area of interest. This will be the focus of this new and improved model of continuous competency.”
The proposed new board also says it wants to make sure this is appropriate to the area in which the clinician is practicing.
“To take a closed book certified exam every 10 years on the world of cardiology as happens at the current time – or the assessments conducted in the other two pathways – is often meaningless to the cardiologist,” Dr. Kuvin says. “All three current pathways involve high stakes questions that are often irrelevant to one’s clinical practice.”
Lifelong Learning
“The crux of the changes we are proposing will be away from the focus of passing a test towards a model of helping the individual with their competency, with continuous learning and evaluation of competency to help the clinician fill in their knowledge gaps,” he explains.
He described the new approach as “lifelong learning,” adding that, instead of it being “a punitive pass/fail environment with no feedback, which causes a lot of discontent among clinicians,” it will be a supportive process, where a clinician will be helped in filling their knowledge gaps.
“I think this would be a welcome change not just for cardiology but across medical specialties,” Dr. Kuvin said.
He also pointed out the ABMS itself is considering a continuous competency approach, and the proposed new cardiology board aims to work with the ABMS to make sure that their goals of continuous competency assessment are matched.
“The world has changed. The ability to access information has changed. It is no longer imperative for a clinician to have every piece of knowledge in their brain, but rather to know how to get knowledge and to incorporate that knowledge into clinical practice,” Dr. Kuvin noted. “Competency should not involve knowledge alone as in a closed book exam. It is more about understanding the world that we live in, how to synthesize information, where we need to improve knowledge and how to do that.”
Dr. Kuvin acknowledged that asking clinicians questions is a very helpful tool to identify their knowledge base and their knowledge gaps. “But we believe the clinician needs to be given resources — that could be a conference, an article, a simulation — to fill that knowledge gap. Then we could ask clinicians some different questions and if they get those right then we have provided a service.”
Tactile skills for cardiologists needing to perform procedures – such as interventionalists or electrophysiologists may be incorporated by simulation in a technology-based scenario.
On how often these assessments would take place, Dr. Kuvin said that hadn’t been decided for sure.
“We certainly do not think an assessment every 10 years is appropriate. We envision, instead of an episodic model, it will be rather a lifelong journey of education and competency. This will involve frequent contact and making sure knowledge gaps are being filled. There are criteria being set out by the ABMS that there should be a certain number of touch points with individuals on an annual as well as a 5-year basis to make sure cardiologists are staying within specific guardrails. The exact nature of these is yet to be determined,” he said.
Dr. Kuvin added that it was not known yet what sort of hours would be required but added that “this will not be a significant time burden.”
What is the Timeframe?
The application to the ABMS for a separate cardiology board is still ongoing and has not yet received formal acceptance. Representatives from the five US cardiovascular societies are in the initial stages of formulating a transition board.
“The submission to the ABMS will take time for them to review. This could take up to a year or so,” Dr. Kuvin estimates.
This is the first time the ABMS has entertained the concept of a new board in many years, he noted. “It will be a paradigm shift for the whole country. I think that cardiology is really at the forefront and in a position where we can actually do this. If cardiovascular medicine is granted a new board, I think this will help change the approach of how physicians are assessed in terms of continuous competency not just in cardiology but across all specialties of medicine.”
He added: “We are confident that we can work within the construct of the ABMS guidelines that have been revised to be much more holistic in the approach of continuous competence across the board. This includes thinking beyond rote medical knowledge and thinking about the clinician as a whole and their abilities to communicate, act professionally, work within a complex medical system, utilize medical resources effectively. These all have to be part of continuous competence.”
How Much Will This Cost?
Noting that the ABIM has received criticism over the costs of the certification process, Dr. Kuvin said they intend to make this “as lean a machine as possible with the focus on reducing the financial [burden] as well as the time burden for cardiologists. It is very important that this is not cumbersome, that it is woven into clinical practice, and that it is not costly.”
But he pointed out that building a new board will have significant costs.
“We have to think about developing initial board certification examinations as well as changing the paradigm on continuous certification,” he said. “This will take some up-front costs, and our society partners have decided that they are willing to provide some start-up funds for this. We anticipate the initial certification will remain somewhat similar in price, but the cost of ongoing continuous competency assessment will be significantly reduced compared to today’s models.”
Dr. Kuvin said the collaboration of the five participating US cardiovascular societies was unprecedented. But he noted that while the transition board is beginning with representatives of these individual societies, it will ultimately be independent from these societies and have its own board of directors.
He suggested that other societies representing other parts of cardiology are also interested. “Cardiology has recognized how important this is,” he said. “Everybody is excited about this.”
A version of this article appeared on Medscape.com.
The proposal by the major cardiovascular societies in the US to form a new board of cardiovascular medicine to manage initial and ongoing certification of cardiologists represents something of a revolution in the field of continuing medical education and assessment of competency.
Five US cardiovascular societies — the American College of Cardiology (ACC), the American Heart Association (AHA), the Heart Failure Society of America (HFSA), the Heart Rhythm Society (HRS), and the Society for Cardiovascular Angiography & Interventions (SCAI) — have now joined forces to propose a new professional certification board for cardiovascular medicine, to be known as the American Board of Cardiovascular Medicine (ABCVM).
The ABCVM would be independent of the American Board of Internal Medicine (ABIM), the current organization providing maintenance of certification for cardiologists as well as many other internal medicine subspecialties. The ABIM’s maintenance of certification process has been widely criticized for many years and has been described as “needlessly burdensome and expensive.”
, according to Jeffrey Kuvin, MD, a trustee of the ACC, who has been heading up the working group to develop this plan.
Dr. Kuvin, who is chair of the cardiology at Northwell Health, Manhasset, New York, a large academic healthcare system, explained that maintenance of certification has been a topic of discussion across the cardiovascular community for many years, and the ACC has a working group focused on the next steps for evaluation of competency, which he chairs.
“The topic of evaluation of competence has been on the mind of the ACC for many years and hence a work group was developed to focus on this,” Dr. Kuvin noted. “A lot of evolution of the concepts and next steps have been drawn out of this working group. And now other cardiovascular societies have joined to show unification across the house of cardiology and that this is indeed the way that the cardiovascular profession should move.”
“Time to Separate from Internal Medicine”
The general concept behind the new cardiology board is to separate cardiology from the ABIM.
“This is rooted from the concept that cardiology has evolved so much over the last few decades into such a large multidimensional specialty that it really does demarcate itself from internal medicine, and as such, it deserves a separate board governed by cardiologists with collaboration across the entirely of cardiology,” Dr. Kuvin said.
Cardiology has had significant growth and expansion of technology, tools, medications, and the approach to patients in many specialities and subspecialties, he added. “We have defined training programs in many different areas within cardiology; we have our own guidelines, our own competency statements, and in many cases, cardiology exists as its own department outside of medicine in many institutions. It’s just time to separate cardiology from the umbrella of internal medicine.”
The new cardiology board would be separate from, and not report to, the ABIM; rather, it would report directly to the American Board of Medical Specialties (ABMS), the only recognized medical certification body in the US.
What Are the Proposed Changes
Under the present system, managed by the ABIM, clinicians must undergo two stages of certification to be a cardiologist. First, they have to pass the initial certification exam in general cardiology, and then exams in one of four subspecialties if they plan to enter one of these, including interventional cardiology, electrophysiology, advanced heart failure or adult congenital heart disease.
Next, clinicians enter the maintenance of certification phase, which can take three different forms: 1) taking another recertification exam every 10 years; 2) the collaborative maintenance pathway — a collaboration between ACC and ABIM, which includes evaluation, learning and a certified exam each year; or 3) longitudinal knowledge and assessment — in which the program interacts with the clinician on an ongoing basis, sending secured questions regularly.
All three of these pathways for maintenance of certification involve high stakes questions and a set bar for passing or failing.
Under the proposed new cardiology board, an initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured, with the new approach taking the form of continuous learning and assessment of competency.
“This is an iterative process, but we envision with a new American Board of Cardiovascular Medicine, we will pick up where the ABIM left off,” Dr. Kuvin notes. “That includes an initial certifying examination for the five areas that already exist under the ABIM system but with the opportunities to expand that to further specialties as well.”
He points out that there are several areas in cardiology that are currently not represented by these five areas that warrant some discussion, including multimodality imaging, vascular heart disease, and cardio-oncology.
“At present, everybody has to pass the general cardiology exam and then some may wish to further train and get certified in one of the other four other specific areas. But one topic that has been discussed over many years is how do we maintain competency in the areas in which clinicians practice over their lifetime as a cardiologist,” Dr. Kuvin commented.
He said the proposed cardiology board would like to adhere to some basic principles that are fundamental to the practice of medicine.
“We want to make sure that we are practicing medicine so that our patients derive the most benefit from seeing a cardiologist,” he said. “We also want to make sure, however, that this is a supportive process, supporting cardiologists to learn what they know and more importantly what they don’t know; to identify knowledge gaps in specific area; to help the cardiologist fill those knowledge gaps; to acknowledge those gaps have been filled; and then move on to another area of interest. This will be the focus of this new and improved model of continuous competency.”
The proposed new board also says it wants to make sure this is appropriate to the area in which the clinician is practicing.
“To take a closed book certified exam every 10 years on the world of cardiology as happens at the current time – or the assessments conducted in the other two pathways – is often meaningless to the cardiologist,” Dr. Kuvin says. “All three current pathways involve high stakes questions that are often irrelevant to one’s clinical practice.”
Lifelong Learning
“The crux of the changes we are proposing will be away from the focus of passing a test towards a model of helping the individual with their competency, with continuous learning and evaluation of competency to help the clinician fill in their knowledge gaps,” he explains.
He described the new approach as “lifelong learning,” adding that, instead of it being “a punitive pass/fail environment with no feedback, which causes a lot of discontent among clinicians,” it will be a supportive process, where a clinician will be helped in filling their knowledge gaps.
“I think this would be a welcome change not just for cardiology but across medical specialties,” Dr. Kuvin said.
He also pointed out the ABMS itself is considering a continuous competency approach, and the proposed new cardiology board aims to work with the ABMS to make sure that their goals of continuous competency assessment are matched.
“The world has changed. The ability to access information has changed. It is no longer imperative for a clinician to have every piece of knowledge in their brain, but rather to know how to get knowledge and to incorporate that knowledge into clinical practice,” Dr. Kuvin noted. “Competency should not involve knowledge alone as in a closed book exam. It is more about understanding the world that we live in, how to synthesize information, where we need to improve knowledge and how to do that.”
Dr. Kuvin acknowledged that asking clinicians questions is a very helpful tool to identify their knowledge base and their knowledge gaps. “But we believe the clinician needs to be given resources — that could be a conference, an article, a simulation — to fill that knowledge gap. Then we could ask clinicians some different questions and if they get those right then we have provided a service.”
Tactile skills for cardiologists needing to perform procedures – such as interventionalists or electrophysiologists may be incorporated by simulation in a technology-based scenario.
On how often these assessments would take place, Dr. Kuvin said that hadn’t been decided for sure.
“We certainly do not think an assessment every 10 years is appropriate. We envision, instead of an episodic model, it will be rather a lifelong journey of education and competency. This will involve frequent contact and making sure knowledge gaps are being filled. There are criteria being set out by the ABMS that there should be a certain number of touch points with individuals on an annual as well as a 5-year basis to make sure cardiologists are staying within specific guardrails. The exact nature of these is yet to be determined,” he said.
Dr. Kuvin added that it was not known yet what sort of hours would be required but added that “this will not be a significant time burden.”
What is the Timeframe?
The application to the ABMS for a separate cardiology board is still ongoing and has not yet received formal acceptance. Representatives from the five US cardiovascular societies are in the initial stages of formulating a transition board.
“The submission to the ABMS will take time for them to review. This could take up to a year or so,” Dr. Kuvin estimates.
This is the first time the ABMS has entertained the concept of a new board in many years, he noted. “It will be a paradigm shift for the whole country. I think that cardiology is really at the forefront and in a position where we can actually do this. If cardiovascular medicine is granted a new board, I think this will help change the approach of how physicians are assessed in terms of continuous competency not just in cardiology but across all specialties of medicine.”
He added: “We are confident that we can work within the construct of the ABMS guidelines that have been revised to be much more holistic in the approach of continuous competence across the board. This includes thinking beyond rote medical knowledge and thinking about the clinician as a whole and their abilities to communicate, act professionally, work within a complex medical system, utilize medical resources effectively. These all have to be part of continuous competence.”
How Much Will This Cost?
Noting that the ABIM has received criticism over the costs of the certification process, Dr. Kuvin said they intend to make this “as lean a machine as possible with the focus on reducing the financial [burden] as well as the time burden for cardiologists. It is very important that this is not cumbersome, that it is woven into clinical practice, and that it is not costly.”
But he pointed out that building a new board will have significant costs.
“We have to think about developing initial board certification examinations as well as changing the paradigm on continuous certification,” he said. “This will take some up-front costs, and our society partners have decided that they are willing to provide some start-up funds for this. We anticipate the initial certification will remain somewhat similar in price, but the cost of ongoing continuous competency assessment will be significantly reduced compared to today’s models.”
Dr. Kuvin said the collaboration of the five participating US cardiovascular societies was unprecedented. But he noted that while the transition board is beginning with representatives of these individual societies, it will ultimately be independent from these societies and have its own board of directors.
He suggested that other societies representing other parts of cardiology are also interested. “Cardiology has recognized how important this is,” he said. “Everybody is excited about this.”
A version of this article appeared on Medscape.com.
The proposal by the major cardiovascular societies in the US to form a new board of cardiovascular medicine to manage initial and ongoing certification of cardiologists represents something of a revolution in the field of continuing medical education and assessment of competency.
Five US cardiovascular societies — the American College of Cardiology (ACC), the American Heart Association (AHA), the Heart Failure Society of America (HFSA), the Heart Rhythm Society (HRS), and the Society for Cardiovascular Angiography & Interventions (SCAI) — have now joined forces to propose a new professional certification board for cardiovascular medicine, to be known as the American Board of Cardiovascular Medicine (ABCVM).
The ABCVM would be independent of the American Board of Internal Medicine (ABIM), the current organization providing maintenance of certification for cardiologists as well as many other internal medicine subspecialties. The ABIM’s maintenance of certification process has been widely criticized for many years and has been described as “needlessly burdensome and expensive.”
, according to Jeffrey Kuvin, MD, a trustee of the ACC, who has been heading up the working group to develop this plan.
Dr. Kuvin, who is chair of the cardiology at Northwell Health, Manhasset, New York, a large academic healthcare system, explained that maintenance of certification has been a topic of discussion across the cardiovascular community for many years, and the ACC has a working group focused on the next steps for evaluation of competency, which he chairs.
“The topic of evaluation of competence has been on the mind of the ACC for many years and hence a work group was developed to focus on this,” Dr. Kuvin noted. “A lot of evolution of the concepts and next steps have been drawn out of this working group. And now other cardiovascular societies have joined to show unification across the house of cardiology and that this is indeed the way that the cardiovascular profession should move.”
“Time to Separate from Internal Medicine”
The general concept behind the new cardiology board is to separate cardiology from the ABIM.
“This is rooted from the concept that cardiology has evolved so much over the last few decades into such a large multidimensional specialty that it really does demarcate itself from internal medicine, and as such, it deserves a separate board governed by cardiologists with collaboration across the entirely of cardiology,” Dr. Kuvin said.
Cardiology has had significant growth and expansion of technology, tools, medications, and the approach to patients in many specialities and subspecialties, he added. “We have defined training programs in many different areas within cardiology; we have our own guidelines, our own competency statements, and in many cases, cardiology exists as its own department outside of medicine in many institutions. It’s just time to separate cardiology from the umbrella of internal medicine.”
The new cardiology board would be separate from, and not report to, the ABIM; rather, it would report directly to the American Board of Medical Specialties (ABMS), the only recognized medical certification body in the US.
What Are the Proposed Changes
Under the present system, managed by the ABIM, clinicians must undergo two stages of certification to be a cardiologist. First, they have to pass the initial certification exam in general cardiology, and then exams in one of four subspecialties if they plan to enter one of these, including interventional cardiology, electrophysiology, advanced heart failure or adult congenital heart disease.
Next, clinicians enter the maintenance of certification phase, which can take three different forms: 1) taking another recertification exam every 10 years; 2) the collaborative maintenance pathway — a collaboration between ACC and ABIM, which includes evaluation, learning and a certified exam each year; or 3) longitudinal knowledge and assessment — in which the program interacts with the clinician on an ongoing basis, sending secured questions regularly.
All three of these pathways for maintenance of certification involve high stakes questions and a set bar for passing or failing.
Under the proposed new cardiology board, an initial certification exam would still be required after fellowship training, but the maintenance of certification process would be completely restructured, with the new approach taking the form of continuous learning and assessment of competency.
“This is an iterative process, but we envision with a new American Board of Cardiovascular Medicine, we will pick up where the ABIM left off,” Dr. Kuvin notes. “That includes an initial certifying examination for the five areas that already exist under the ABIM system but with the opportunities to expand that to further specialties as well.”
He points out that there are several areas in cardiology that are currently not represented by these five areas that warrant some discussion, including multimodality imaging, vascular heart disease, and cardio-oncology.
“At present, everybody has to pass the general cardiology exam and then some may wish to further train and get certified in one of the other four other specific areas. But one topic that has been discussed over many years is how do we maintain competency in the areas in which clinicians practice over their lifetime as a cardiologist,” Dr. Kuvin commented.
He said the proposed cardiology board would like to adhere to some basic principles that are fundamental to the practice of medicine.
“We want to make sure that we are practicing medicine so that our patients derive the most benefit from seeing a cardiologist,” he said. “We also want to make sure, however, that this is a supportive process, supporting cardiologists to learn what they know and more importantly what they don’t know; to identify knowledge gaps in specific area; to help the cardiologist fill those knowledge gaps; to acknowledge those gaps have been filled; and then move on to another area of interest. This will be the focus of this new and improved model of continuous competency.”
The proposed new board also says it wants to make sure this is appropriate to the area in which the clinician is practicing.
“To take a closed book certified exam every 10 years on the world of cardiology as happens at the current time – or the assessments conducted in the other two pathways – is often meaningless to the cardiologist,” Dr. Kuvin says. “All three current pathways involve high stakes questions that are often irrelevant to one’s clinical practice.”
Lifelong Learning
“The crux of the changes we are proposing will be away from the focus of passing a test towards a model of helping the individual with their competency, with continuous learning and evaluation of competency to help the clinician fill in their knowledge gaps,” he explains.
He described the new approach as “lifelong learning,” adding that, instead of it being “a punitive pass/fail environment with no feedback, which causes a lot of discontent among clinicians,” it will be a supportive process, where a clinician will be helped in filling their knowledge gaps.
“I think this would be a welcome change not just for cardiology but across medical specialties,” Dr. Kuvin said.
He also pointed out the ABMS itself is considering a continuous competency approach, and the proposed new cardiology board aims to work with the ABMS to make sure that their goals of continuous competency assessment are matched.
“The world has changed. The ability to access information has changed. It is no longer imperative for a clinician to have every piece of knowledge in their brain, but rather to know how to get knowledge and to incorporate that knowledge into clinical practice,” Dr. Kuvin noted. “Competency should not involve knowledge alone as in a closed book exam. It is more about understanding the world that we live in, how to synthesize information, where we need to improve knowledge and how to do that.”
Dr. Kuvin acknowledged that asking clinicians questions is a very helpful tool to identify their knowledge base and their knowledge gaps. “But we believe the clinician needs to be given resources — that could be a conference, an article, a simulation — to fill that knowledge gap. Then we could ask clinicians some different questions and if they get those right then we have provided a service.”
Tactile skills for cardiologists needing to perform procedures – such as interventionalists or electrophysiologists may be incorporated by simulation in a technology-based scenario.
On how often these assessments would take place, Dr. Kuvin said that hadn’t been decided for sure.
“We certainly do not think an assessment every 10 years is appropriate. We envision, instead of an episodic model, it will be rather a lifelong journey of education and competency. This will involve frequent contact and making sure knowledge gaps are being filled. There are criteria being set out by the ABMS that there should be a certain number of touch points with individuals on an annual as well as a 5-year basis to make sure cardiologists are staying within specific guardrails. The exact nature of these is yet to be determined,” he said.
Dr. Kuvin added that it was not known yet what sort of hours would be required but added that “this will not be a significant time burden.”
What is the Timeframe?
The application to the ABMS for a separate cardiology board is still ongoing and has not yet received formal acceptance. Representatives from the five US cardiovascular societies are in the initial stages of formulating a transition board.
“The submission to the ABMS will take time for them to review. This could take up to a year or so,” Dr. Kuvin estimates.
This is the first time the ABMS has entertained the concept of a new board in many years, he noted. “It will be a paradigm shift for the whole country. I think that cardiology is really at the forefront and in a position where we can actually do this. If cardiovascular medicine is granted a new board, I think this will help change the approach of how physicians are assessed in terms of continuous competency not just in cardiology but across all specialties of medicine.”
He added: “We are confident that we can work within the construct of the ABMS guidelines that have been revised to be much more holistic in the approach of continuous competence across the board. This includes thinking beyond rote medical knowledge and thinking about the clinician as a whole and their abilities to communicate, act professionally, work within a complex medical system, utilize medical resources effectively. These all have to be part of continuous competence.”
How Much Will This Cost?
Noting that the ABIM has received criticism over the costs of the certification process, Dr. Kuvin said they intend to make this “as lean a machine as possible with the focus on reducing the financial [burden] as well as the time burden for cardiologists. It is very important that this is not cumbersome, that it is woven into clinical practice, and that it is not costly.”
But he pointed out that building a new board will have significant costs.
“We have to think about developing initial board certification examinations as well as changing the paradigm on continuous certification,” he said. “This will take some up-front costs, and our society partners have decided that they are willing to provide some start-up funds for this. We anticipate the initial certification will remain somewhat similar in price, but the cost of ongoing continuous competency assessment will be significantly reduced compared to today’s models.”
Dr. Kuvin said the collaboration of the five participating US cardiovascular societies was unprecedented. But he noted that while the transition board is beginning with representatives of these individual societies, it will ultimately be independent from these societies and have its own board of directors.
He suggested that other societies representing other parts of cardiology are also interested. “Cardiology has recognized how important this is,” he said. “Everybody is excited about this.”
A version of this article appeared on Medscape.com.
Sleep problems exact high toll in women with breast cancer
SAN ANTONIO — Poor sleep quality and short sleep duration in particular were associated with poorer mental well-being.
“It’s important to ask patients [with breast cancer] about sleep and provide targeted interventions to improve sleep, when needed, to improve quality of life,” Lin Yang, PhD, with Cancer Care Alberta and University of Calgary, Canada, said in an interview.
The growing population of breast cancer survivors, particularly in developed countries, is burdened by a high prevalence of sleep problems, affecting more than half of the survivors, Dr. Yang said at the San Antonio Breast Cancer Symposium.
The AMBER cohort study delved into how sleep health aspects, including sleep duration, timing, and quality, relate to the physical and mental well-being of women recently diagnosed with breast cancer.
The study recruited 1409 women with newly diagnosed early-stage breast cancer from Edmonton and Calgary, Canada, between 2012 and 2019.
The women completed the Pittsburgh Sleep Quality Index (PSQI) to assess habitual sleep duration and timing as well as sleep latency, efficiency, disturbance, medication, and daytime dysfunction and version two of the Short Form-36 (SF-36) to assess physical and mental well-being.
Multivariable linear regressions were used to estimate the association of sleep characteristics with physical and mental well-being, adjusting for sociodemographic, disease, clinical, and lifestyle behavior factors.
Among the total patient cohort (mean age, 55 years), 41% experienced either short sleep duration (less than 6 h/d) or long sleep duration (more than 9 h/d), and the same percentage also reported regularly going to bed after 11 PM.
Of note, said Dr. Yang, in the multivariable model, short sleep duration was significantly associated with poorer mental well-being (beta-coefficient, -3.6; 95% CI, -4.7 to -2.4) but not poorer physical well-being (beta-coefficient, -1.5; 95% CI, -2.3 to -0.7).
Sleep timing didn’t appear to have a meaningful impact on quality of life.
However, poor sleep quality, measured through various metrics like sleep efficiency, disturbances, medication use, and daytime dysfunction, correlated with reduced physical and mental well-being, Dr. Yang said.
She noted that targeted interventions to improve sleep health may lead to improvements in the quality of life among women with newly diagnosed breast cancer.
“Sleep is something we don’t necessarily think about in patients with breast cancer,” said Don Dizon, MD, with Brown University, Providence, Rhode Island, discussant for the study presentation.
However, this study shows the “clinical significance” of sleep, he said. “Notably 35% of this population is taking a sleeping pill.”
Dr. Yang is an editorial board member of the Journal of Healthy Eating and Active Living. Dr. Dizon receives consulting fees from Astra Zeneca, Glaxo Smith Kline, Kronos Bio, and Pfizer and industry grant support from Bristol-Myers Squibb.
A version of this article appeared on Medscape.com.
SAN ANTONIO — Poor sleep quality and short sleep duration in particular were associated with poorer mental well-being.
“It’s important to ask patients [with breast cancer] about sleep and provide targeted interventions to improve sleep, when needed, to improve quality of life,” Lin Yang, PhD, with Cancer Care Alberta and University of Calgary, Canada, said in an interview.
The growing population of breast cancer survivors, particularly in developed countries, is burdened by a high prevalence of sleep problems, affecting more than half of the survivors, Dr. Yang said at the San Antonio Breast Cancer Symposium.
The AMBER cohort study delved into how sleep health aspects, including sleep duration, timing, and quality, relate to the physical and mental well-being of women recently diagnosed with breast cancer.
The study recruited 1409 women with newly diagnosed early-stage breast cancer from Edmonton and Calgary, Canada, between 2012 and 2019.
The women completed the Pittsburgh Sleep Quality Index (PSQI) to assess habitual sleep duration and timing as well as sleep latency, efficiency, disturbance, medication, and daytime dysfunction and version two of the Short Form-36 (SF-36) to assess physical and mental well-being.
Multivariable linear regressions were used to estimate the association of sleep characteristics with physical and mental well-being, adjusting for sociodemographic, disease, clinical, and lifestyle behavior factors.
Among the total patient cohort (mean age, 55 years), 41% experienced either short sleep duration (less than 6 h/d) or long sleep duration (more than 9 h/d), and the same percentage also reported regularly going to bed after 11 PM.
Of note, said Dr. Yang, in the multivariable model, short sleep duration was significantly associated with poorer mental well-being (beta-coefficient, -3.6; 95% CI, -4.7 to -2.4) but not poorer physical well-being (beta-coefficient, -1.5; 95% CI, -2.3 to -0.7).
Sleep timing didn’t appear to have a meaningful impact on quality of life.
However, poor sleep quality, measured through various metrics like sleep efficiency, disturbances, medication use, and daytime dysfunction, correlated with reduced physical and mental well-being, Dr. Yang said.
She noted that targeted interventions to improve sleep health may lead to improvements in the quality of life among women with newly diagnosed breast cancer.
“Sleep is something we don’t necessarily think about in patients with breast cancer,” said Don Dizon, MD, with Brown University, Providence, Rhode Island, discussant for the study presentation.
However, this study shows the “clinical significance” of sleep, he said. “Notably 35% of this population is taking a sleeping pill.”
Dr. Yang is an editorial board member of the Journal of Healthy Eating and Active Living. Dr. Dizon receives consulting fees from Astra Zeneca, Glaxo Smith Kline, Kronos Bio, and Pfizer and industry grant support from Bristol-Myers Squibb.
A version of this article appeared on Medscape.com.
SAN ANTONIO — Poor sleep quality and short sleep duration in particular were associated with poorer mental well-being.
“It’s important to ask patients [with breast cancer] about sleep and provide targeted interventions to improve sleep, when needed, to improve quality of life,” Lin Yang, PhD, with Cancer Care Alberta and University of Calgary, Canada, said in an interview.
The growing population of breast cancer survivors, particularly in developed countries, is burdened by a high prevalence of sleep problems, affecting more than half of the survivors, Dr. Yang said at the San Antonio Breast Cancer Symposium.
The AMBER cohort study delved into how sleep health aspects, including sleep duration, timing, and quality, relate to the physical and mental well-being of women recently diagnosed with breast cancer.
The study recruited 1409 women with newly diagnosed early-stage breast cancer from Edmonton and Calgary, Canada, between 2012 and 2019.
The women completed the Pittsburgh Sleep Quality Index (PSQI) to assess habitual sleep duration and timing as well as sleep latency, efficiency, disturbance, medication, and daytime dysfunction and version two of the Short Form-36 (SF-36) to assess physical and mental well-being.
Multivariable linear regressions were used to estimate the association of sleep characteristics with physical and mental well-being, adjusting for sociodemographic, disease, clinical, and lifestyle behavior factors.
Among the total patient cohort (mean age, 55 years), 41% experienced either short sleep duration (less than 6 h/d) or long sleep duration (more than 9 h/d), and the same percentage also reported regularly going to bed after 11 PM.
Of note, said Dr. Yang, in the multivariable model, short sleep duration was significantly associated with poorer mental well-being (beta-coefficient, -3.6; 95% CI, -4.7 to -2.4) but not poorer physical well-being (beta-coefficient, -1.5; 95% CI, -2.3 to -0.7).
Sleep timing didn’t appear to have a meaningful impact on quality of life.
However, poor sleep quality, measured through various metrics like sleep efficiency, disturbances, medication use, and daytime dysfunction, correlated with reduced physical and mental well-being, Dr. Yang said.
She noted that targeted interventions to improve sleep health may lead to improvements in the quality of life among women with newly diagnosed breast cancer.
“Sleep is something we don’t necessarily think about in patients with breast cancer,” said Don Dizon, MD, with Brown University, Providence, Rhode Island, discussant for the study presentation.
However, this study shows the “clinical significance” of sleep, he said. “Notably 35% of this population is taking a sleeping pill.”
Dr. Yang is an editorial board member of the Journal of Healthy Eating and Active Living. Dr. Dizon receives consulting fees from Astra Zeneca, Glaxo Smith Kline, Kronos Bio, and Pfizer and industry grant support from Bristol-Myers Squibb.
A version of this article appeared on Medscape.com.
FROM SABCS 2023
Some reasons to get off the fence about COVID booster
Though many people remain on the fence about getting the latest COVID vaccine booster, new research suggests a strong argument for getting the shot this winter: It sharply reduces the risk for COVID.
The risk reduction was 37% for those who received two doses. Experts say the research provides a strong argument for getting the vaccine, noting that about 10% of people infected with COVID go on to have long COVID, which can be debilitating for one quarter of those with long-lasting symptoms.
The data come from a systematic literature review and meta-analysis published in October in Antimicrobial Stewardship & Epidemiology. Researchers examined 32 studies published between December 2019 and June 2023, involving 775,931 adults. Twenty-four studies, encompassing 620,221 individuals, were included in the meta-analysis.
“The body of evidence from all these different studies converge on one single reality — that vaccines reduce the risk of long COVID, and people who keep up to date on their vaccinations also fared better than people who got it once or twice and didn’t follow up,” said Ziyad Al-Aly, MD, a clinical epidemiologist at Washington University in St Louis.
Researchers have reported similar results for children. The National Institutes of Health RECOVER Initiative team found that vaccines are up to 42% effective in preventing long COVID in children, said Dr. Carlos Oliveira, MD, a pediatric infectious diseases specialist and Yale researcher who contributed to the study, which is in preprint.
Vaccines also protect children from multisystem inflammatory syndrome, a condition that can happen after COVID, as well as protect against other COVID-related problems, such as missed school days, Oliveira said. “Even if the vaccine doesn’t completely stop long COVID, it’s still good for kids to get vaccinated for all these other reasons.”
However, uptake for the latest boosters has been slow: the Centers for Disease Control and Prevention reported that by mid-November, less than 16% of people aged 18 years or older had received a shot. For children, the number was closer to 6%. A recent Kaiser Family Foundation survey found that booster rates for adults are similar to what it was 1 year ago.
The survey results suggest that people are no longer as worried about COVID, which is why there is less concerned about keeping up with boosters. Though the current mutation of the virus is not as debilitating as its predecessors, long COVID continues to be a problem: as of January 2023, 28% of people who had contracted the virus had experienced long-COVID symptoms. And though the mechanisms are still not fully understood, and researchers have yet to agree on a definition of long COVID, they are certain about this much: The best way to avoid it is to avoid getting infected to begin with.
The lack of a diagnostic test for long COVID and the fact that the symptoms mimic those of other diseases lead to inconsistency that can make studies hard to replicate. In the papers reviewed for the Antimicrobial Stewardship & Epidemiology study, long COVID was defined as having symptoms lasting from more than 4 weeks to more than 6 months. Alexandre Marra, MD, the lead author and a researcher at the Hospital Israelita Albert Einstein, in São Paulo, Brazil, and at the University of Iowa, said that a clear standard definition is needed to better understand the actual prevalence and evaluate vaccine effectiveness.
Al-Aly noted that there is a logical explanation for one finding in the paper: The percentage of individuals who had COVID and reported that long-COVID symptoms declined from 19% in June 2022 to 11% in January 2023.
Because a pandemic is a dynamic event, constantly producing different variants with different phenotypes, the prevalence of disease is naturally going to be affected. “People who got infected early in the pandemic may have a different long COVID profile and long COVID risk than people who got infected in the second or third year of the pandemic,” Al-Aly said.
Most of the studies reported data from before the Omicron-variant era. Only eight reported data during that era. Omicron was not as lethal as previous variants, and consequently, fewer patients developed long COVID during that time.
One of those who did is Yeng Chang, age 40 years, a family doctor who lives in Sherwood Park, Alberta, Canada. Chang developed long COVID during fall 2022 after getting the virus in June. By then, she’d been vaccinated three times, but she isn’t surprised that she got sick because each vaccine she had was developed before Omicron.
“When I had COVID I was really sick, but I was well enough to stay home,” she said. “I think if I didn’t have my immunizations, I might have been hospitalized, and I don’t know what would have happened.”
Long COVID has left Chang with brain fog, fatigue, and a lack of physical stamina that forced her to pause her medical practice. For the past year and a half, she’s spent more time as a patient than a physician.
Chang had her fifth COVID vaccination in the fall and recommends that others do the same. “The booster you got however many years ago was effective for the COVID of that time but there is a new COVID now. You can’t just say, ‘I had one and I’m fine forever.’”
A version of this article appeared on Medscape.com.
Though many people remain on the fence about getting the latest COVID vaccine booster, new research suggests a strong argument for getting the shot this winter: It sharply reduces the risk for COVID.
The risk reduction was 37% for those who received two doses. Experts say the research provides a strong argument for getting the vaccine, noting that about 10% of people infected with COVID go on to have long COVID, which can be debilitating for one quarter of those with long-lasting symptoms.
The data come from a systematic literature review and meta-analysis published in October in Antimicrobial Stewardship & Epidemiology. Researchers examined 32 studies published between December 2019 and June 2023, involving 775,931 adults. Twenty-four studies, encompassing 620,221 individuals, were included in the meta-analysis.
“The body of evidence from all these different studies converge on one single reality — that vaccines reduce the risk of long COVID, and people who keep up to date on their vaccinations also fared better than people who got it once or twice and didn’t follow up,” said Ziyad Al-Aly, MD, a clinical epidemiologist at Washington University in St Louis.
Researchers have reported similar results for children. The National Institutes of Health RECOVER Initiative team found that vaccines are up to 42% effective in preventing long COVID in children, said Dr. Carlos Oliveira, MD, a pediatric infectious diseases specialist and Yale researcher who contributed to the study, which is in preprint.
Vaccines also protect children from multisystem inflammatory syndrome, a condition that can happen after COVID, as well as protect against other COVID-related problems, such as missed school days, Oliveira said. “Even if the vaccine doesn’t completely stop long COVID, it’s still good for kids to get vaccinated for all these other reasons.”
However, uptake for the latest boosters has been slow: the Centers for Disease Control and Prevention reported that by mid-November, less than 16% of people aged 18 years or older had received a shot. For children, the number was closer to 6%. A recent Kaiser Family Foundation survey found that booster rates for adults are similar to what it was 1 year ago.
The survey results suggest that people are no longer as worried about COVID, which is why there is less concerned about keeping up with boosters. Though the current mutation of the virus is not as debilitating as its predecessors, long COVID continues to be a problem: as of January 2023, 28% of people who had contracted the virus had experienced long-COVID symptoms. And though the mechanisms are still not fully understood, and researchers have yet to agree on a definition of long COVID, they are certain about this much: The best way to avoid it is to avoid getting infected to begin with.
The lack of a diagnostic test for long COVID and the fact that the symptoms mimic those of other diseases lead to inconsistency that can make studies hard to replicate. In the papers reviewed for the Antimicrobial Stewardship & Epidemiology study, long COVID was defined as having symptoms lasting from more than 4 weeks to more than 6 months. Alexandre Marra, MD, the lead author and a researcher at the Hospital Israelita Albert Einstein, in São Paulo, Brazil, and at the University of Iowa, said that a clear standard definition is needed to better understand the actual prevalence and evaluate vaccine effectiveness.
Al-Aly noted that there is a logical explanation for one finding in the paper: The percentage of individuals who had COVID and reported that long-COVID symptoms declined from 19% in June 2022 to 11% in January 2023.
Because a pandemic is a dynamic event, constantly producing different variants with different phenotypes, the prevalence of disease is naturally going to be affected. “People who got infected early in the pandemic may have a different long COVID profile and long COVID risk than people who got infected in the second or third year of the pandemic,” Al-Aly said.
Most of the studies reported data from before the Omicron-variant era. Only eight reported data during that era. Omicron was not as lethal as previous variants, and consequently, fewer patients developed long COVID during that time.
One of those who did is Yeng Chang, age 40 years, a family doctor who lives in Sherwood Park, Alberta, Canada. Chang developed long COVID during fall 2022 after getting the virus in June. By then, she’d been vaccinated three times, but she isn’t surprised that she got sick because each vaccine she had was developed before Omicron.
“When I had COVID I was really sick, but I was well enough to stay home,” she said. “I think if I didn’t have my immunizations, I might have been hospitalized, and I don’t know what would have happened.”
Long COVID has left Chang with brain fog, fatigue, and a lack of physical stamina that forced her to pause her medical practice. For the past year and a half, she’s spent more time as a patient than a physician.
Chang had her fifth COVID vaccination in the fall and recommends that others do the same. “The booster you got however many years ago was effective for the COVID of that time but there is a new COVID now. You can’t just say, ‘I had one and I’m fine forever.’”
A version of this article appeared on Medscape.com.
Though many people remain on the fence about getting the latest COVID vaccine booster, new research suggests a strong argument for getting the shot this winter: It sharply reduces the risk for COVID.
The risk reduction was 37% for those who received two doses. Experts say the research provides a strong argument for getting the vaccine, noting that about 10% of people infected with COVID go on to have long COVID, which can be debilitating for one quarter of those with long-lasting symptoms.
The data come from a systematic literature review and meta-analysis published in October in Antimicrobial Stewardship & Epidemiology. Researchers examined 32 studies published between December 2019 and June 2023, involving 775,931 adults. Twenty-four studies, encompassing 620,221 individuals, were included in the meta-analysis.
“The body of evidence from all these different studies converge on one single reality — that vaccines reduce the risk of long COVID, and people who keep up to date on their vaccinations also fared better than people who got it once or twice and didn’t follow up,” said Ziyad Al-Aly, MD, a clinical epidemiologist at Washington University in St Louis.
Researchers have reported similar results for children. The National Institutes of Health RECOVER Initiative team found that vaccines are up to 42% effective in preventing long COVID in children, said Dr. Carlos Oliveira, MD, a pediatric infectious diseases specialist and Yale researcher who contributed to the study, which is in preprint.
Vaccines also protect children from multisystem inflammatory syndrome, a condition that can happen after COVID, as well as protect against other COVID-related problems, such as missed school days, Oliveira said. “Even if the vaccine doesn’t completely stop long COVID, it’s still good for kids to get vaccinated for all these other reasons.”
However, uptake for the latest boosters has been slow: the Centers for Disease Control and Prevention reported that by mid-November, less than 16% of people aged 18 years or older had received a shot. For children, the number was closer to 6%. A recent Kaiser Family Foundation survey found that booster rates for adults are similar to what it was 1 year ago.
The survey results suggest that people are no longer as worried about COVID, which is why there is less concerned about keeping up with boosters. Though the current mutation of the virus is not as debilitating as its predecessors, long COVID continues to be a problem: as of January 2023, 28% of people who had contracted the virus had experienced long-COVID symptoms. And though the mechanisms are still not fully understood, and researchers have yet to agree on a definition of long COVID, they are certain about this much: The best way to avoid it is to avoid getting infected to begin with.
The lack of a diagnostic test for long COVID and the fact that the symptoms mimic those of other diseases lead to inconsistency that can make studies hard to replicate. In the papers reviewed for the Antimicrobial Stewardship & Epidemiology study, long COVID was defined as having symptoms lasting from more than 4 weeks to more than 6 months. Alexandre Marra, MD, the lead author and a researcher at the Hospital Israelita Albert Einstein, in São Paulo, Brazil, and at the University of Iowa, said that a clear standard definition is needed to better understand the actual prevalence and evaluate vaccine effectiveness.
Al-Aly noted that there is a logical explanation for one finding in the paper: The percentage of individuals who had COVID and reported that long-COVID symptoms declined from 19% in June 2022 to 11% in January 2023.
Because a pandemic is a dynamic event, constantly producing different variants with different phenotypes, the prevalence of disease is naturally going to be affected. “People who got infected early in the pandemic may have a different long COVID profile and long COVID risk than people who got infected in the second or third year of the pandemic,” Al-Aly said.
Most of the studies reported data from before the Omicron-variant era. Only eight reported data during that era. Omicron was not as lethal as previous variants, and consequently, fewer patients developed long COVID during that time.
One of those who did is Yeng Chang, age 40 years, a family doctor who lives in Sherwood Park, Alberta, Canada. Chang developed long COVID during fall 2022 after getting the virus in June. By then, she’d been vaccinated three times, but she isn’t surprised that she got sick because each vaccine she had was developed before Omicron.
“When I had COVID I was really sick, but I was well enough to stay home,” she said. “I think if I didn’t have my immunizations, I might have been hospitalized, and I don’t know what would have happened.”
Long COVID has left Chang with brain fog, fatigue, and a lack of physical stamina that forced her to pause her medical practice. For the past year and a half, she’s spent more time as a patient than a physician.
Chang had her fifth COVID vaccination in the fall and recommends that others do the same. “The booster you got however many years ago was effective for the COVID of that time but there is a new COVID now. You can’t just say, ‘I had one and I’m fine forever.’”
A version of this article appeared on Medscape.com.
Elagolix curbs heavy bleeding linked to uterine leiomyomas
Uterine leiomyomas are common in premenopausal women, and 60% experience heavy menstrual bleeding, but nonsurgical options as an alternative to hysterectomy are limited, wrote Eric Brown, MD, of Gyn-Care, Atlanta, Georgia, and colleagues.
Elagolix sodium, an oral, short-acting nonpeptide, gonadotropin-releasing hormone antagonist, has been approved by the Food and Drug Administration at a dose of 300 mg twice daily with add-back therapy for up to 24 months of use. However, this treatment protocol is contraindicated or not preferable for some patients, the researchers said.
In a study published in Obstetrics & Gynecology , the researchers randomized 54 women to 150 mg of oral elagolix once daily, and 28 to a placebo for 6 months to investigate the safety and efficacy of the lower dose. The study population included women aged 18-51 years with a history of heavy menstrual bleeding association with uterine leiomyomas. Approximately two-thirds (65.9%) were Black.
The primary endpoint was the proportion of patients who met the criteria of menstrual blood loss volume less than 80 mL during the final month of treatment and menstrual blood loss volume reduction of 50% or more from baseline to the final month of treatment.
After 6 months, nearly half (49.4%) of the elagolix group met the study endpoint compared with 23.3% of the placebo group (P = .035).
Elagolix patients showed significantly greater reductions in both mean and median menstrual blood loss volumes compared with the placebo patients over the study period, and significant differences between the groups in the mean reduction of menstrual blood loss were evident after 1 month of treatment (P < .05 for months 1, 2, 3, and 5).
Results were similar in a further sensitivity analysis in which patients with incomplete final month data were considered nonresponders; 44.4% of elagolix patients and 21.4% of patients met the primary endpoint.
Overall, 51.9% of elagolix patients and 39.3% of placebo patients reported adverse events; the most common were headache and hot flush. Three patients (5.6%) in the elagolix group discontinued the drug because of adverse events. No serious or severe adverse events were reported in the elagolix group; both cases of reported serious adverse events (COVID-19 and an enlarged uvula) occurred in placebo patients.
Patient-reported outcomes were significantly greater in the elagolix patients, based on symptom severity score, 5 of 6 Uterine Fibroid Symptom and Quality of Life (UFS-QOL) health-related quality of life subscales, and the HRQOL total score at the end of the study.
The findings were limited by several factors including the small study population and lenient eligibility criteria that may have led to a higher placebo response rate, and the study did not monitor bone mineral density, the researchers noted.
However, the results suggest that elagolix at a 150-mg dose was well tolerated, with a safety profile similar to that seen in women who took the drug for endometriosis pain, and may be an option for women with contraindications to other therapy or for those who prefer once-daily dosing, they concluded.
The study was funded by AbbVie. Lead author Dr. Brown had no additional financial conflicts to disclose, but several coauthors disclosed relationships with AbbVie and other companies.
Uterine leiomyomas are common in premenopausal women, and 60% experience heavy menstrual bleeding, but nonsurgical options as an alternative to hysterectomy are limited, wrote Eric Brown, MD, of Gyn-Care, Atlanta, Georgia, and colleagues.
Elagolix sodium, an oral, short-acting nonpeptide, gonadotropin-releasing hormone antagonist, has been approved by the Food and Drug Administration at a dose of 300 mg twice daily with add-back therapy for up to 24 months of use. However, this treatment protocol is contraindicated or not preferable for some patients, the researchers said.
In a study published in Obstetrics & Gynecology , the researchers randomized 54 women to 150 mg of oral elagolix once daily, and 28 to a placebo for 6 months to investigate the safety and efficacy of the lower dose. The study population included women aged 18-51 years with a history of heavy menstrual bleeding association with uterine leiomyomas. Approximately two-thirds (65.9%) were Black.
The primary endpoint was the proportion of patients who met the criteria of menstrual blood loss volume less than 80 mL during the final month of treatment and menstrual blood loss volume reduction of 50% or more from baseline to the final month of treatment.
After 6 months, nearly half (49.4%) of the elagolix group met the study endpoint compared with 23.3% of the placebo group (P = .035).
Elagolix patients showed significantly greater reductions in both mean and median menstrual blood loss volumes compared with the placebo patients over the study period, and significant differences between the groups in the mean reduction of menstrual blood loss were evident after 1 month of treatment (P < .05 for months 1, 2, 3, and 5).
Results were similar in a further sensitivity analysis in which patients with incomplete final month data were considered nonresponders; 44.4% of elagolix patients and 21.4% of patients met the primary endpoint.
Overall, 51.9% of elagolix patients and 39.3% of placebo patients reported adverse events; the most common were headache and hot flush. Three patients (5.6%) in the elagolix group discontinued the drug because of adverse events. No serious or severe adverse events were reported in the elagolix group; both cases of reported serious adverse events (COVID-19 and an enlarged uvula) occurred in placebo patients.
Patient-reported outcomes were significantly greater in the elagolix patients, based on symptom severity score, 5 of 6 Uterine Fibroid Symptom and Quality of Life (UFS-QOL) health-related quality of life subscales, and the HRQOL total score at the end of the study.
The findings were limited by several factors including the small study population and lenient eligibility criteria that may have led to a higher placebo response rate, and the study did not monitor bone mineral density, the researchers noted.
However, the results suggest that elagolix at a 150-mg dose was well tolerated, with a safety profile similar to that seen in women who took the drug for endometriosis pain, and may be an option for women with contraindications to other therapy or for those who prefer once-daily dosing, they concluded.
The study was funded by AbbVie. Lead author Dr. Brown had no additional financial conflicts to disclose, but several coauthors disclosed relationships with AbbVie and other companies.
Uterine leiomyomas are common in premenopausal women, and 60% experience heavy menstrual bleeding, but nonsurgical options as an alternative to hysterectomy are limited, wrote Eric Brown, MD, of Gyn-Care, Atlanta, Georgia, and colleagues.
Elagolix sodium, an oral, short-acting nonpeptide, gonadotropin-releasing hormone antagonist, has been approved by the Food and Drug Administration at a dose of 300 mg twice daily with add-back therapy for up to 24 months of use. However, this treatment protocol is contraindicated or not preferable for some patients, the researchers said.
In a study published in Obstetrics & Gynecology , the researchers randomized 54 women to 150 mg of oral elagolix once daily, and 28 to a placebo for 6 months to investigate the safety and efficacy of the lower dose. The study population included women aged 18-51 years with a history of heavy menstrual bleeding association with uterine leiomyomas. Approximately two-thirds (65.9%) were Black.
The primary endpoint was the proportion of patients who met the criteria of menstrual blood loss volume less than 80 mL during the final month of treatment and menstrual blood loss volume reduction of 50% or more from baseline to the final month of treatment.
After 6 months, nearly half (49.4%) of the elagolix group met the study endpoint compared with 23.3% of the placebo group (P = .035).
Elagolix patients showed significantly greater reductions in both mean and median menstrual blood loss volumes compared with the placebo patients over the study period, and significant differences between the groups in the mean reduction of menstrual blood loss were evident after 1 month of treatment (P < .05 for months 1, 2, 3, and 5).
Results were similar in a further sensitivity analysis in which patients with incomplete final month data were considered nonresponders; 44.4% of elagolix patients and 21.4% of patients met the primary endpoint.
Overall, 51.9% of elagolix patients and 39.3% of placebo patients reported adverse events; the most common were headache and hot flush. Three patients (5.6%) in the elagolix group discontinued the drug because of adverse events. No serious or severe adverse events were reported in the elagolix group; both cases of reported serious adverse events (COVID-19 and an enlarged uvula) occurred in placebo patients.
Patient-reported outcomes were significantly greater in the elagolix patients, based on symptom severity score, 5 of 6 Uterine Fibroid Symptom and Quality of Life (UFS-QOL) health-related quality of life subscales, and the HRQOL total score at the end of the study.
The findings were limited by several factors including the small study population and lenient eligibility criteria that may have led to a higher placebo response rate, and the study did not monitor bone mineral density, the researchers noted.
However, the results suggest that elagolix at a 150-mg dose was well tolerated, with a safety profile similar to that seen in women who took the drug for endometriosis pain, and may be an option for women with contraindications to other therapy or for those who prefer once-daily dosing, they concluded.
The study was funded by AbbVie. Lead author Dr. Brown had no additional financial conflicts to disclose, but several coauthors disclosed relationships with AbbVie and other companies.
FROM OBSTETRICS & GYNECOLOGY
AI-guided colonoscopy results in more small adenomas detected
according to results from a large meta-analysis of randomized controlled trials.
But while adenoma detection rates increased by nearly 25%, compared with conventional care, the AI-guided procedures were also associated with an increase in unnecessary removal of non-neoplastic polyps. Little effect was seen on the detection of larger, advanced lesions.
The findings, published in Annals of Internal Medicine, are likely to change clinical guidelines in favor of AI-assisted procedures, said Cesare Hassan, MD, PhD, of Humanitas Research Hospital and University in Milan, Italy.
For their research, Dr. Hassan and his colleagues looked at results from 21 trials randomizing more than 18,000 patients to colonoscopy with computer-aided detection (CADe) or standard colonoscopy. Colonoscopy could be carried out for screening, surveillance, or diagnostic purposes. The included trials, which were all published in 2019 or later, took place in Asia, North America, and Europe. In most of the studies endoscopists were not blinded to treatment allocation.
The adenoma detection rate, or the proportion of individuals undergoing colonoscopy who had at least one adenoma detected and removed, was 44% in the CADe arms, compared with 35.9% assigned to standard care (relative risk [RR], 1.24; 95% CI, 1.16-1.33). The CADe patients also saw more non-neoplastic polyps removed: 0.52 per colonoscopy, compared with 0.34 for standard care. The increased adenoma detection rate appeared to be driven by a 55% decrease in the error or miss rate of adenomas at per-polyp analysis, the investigators wrote in their paper.
CADe did not increase the number of advanced adenomas (defined as greater than 10 mm, with high-grade dysplasia and villous histology) detected per colonoscopy. Rather, the benefit was “mainly limited to increased detection of diminutive (≤5 mm) adenomas,” the investigators wrote. Dr. Hassan commented that the lack of benefit for detecting larger adenomas was expected, as these are easier for endoscopists to identify visually.
The key limitation of the meta-analysis, Dr. Hassan said, was the fact that endoscopists in the studies could not be blinded. “We can assume there is a risk of bias in our estimates — that is why we describe the quality of evidence as low or moderate, never high. Through randomization we can control other aspects, especially the prevalence of disease, which avoids a scenario in which the endoscopist opts to treat riskier patients with CADe.” But the possibility of a change in the endoscopist’s performance when using these systems cannot be excluded.
Dr. Hassan commented that quantifying the risks, and costs, of overtreatment linked to CADe would require more investigation. “Any time I remove a polyp there’s a risk of perforation and bleeding,” he noted, though most of the unnecessary resections seen in the meta-analysis were of small hyperplastic polyps considered to be low risk for complications. Use of CADe was associated with only slight increases in procedure time, the investigators found.
In a multicenter Spanish study also published in Annals of Internal Medicine, Carolina Mangas-Sanjuan, MD, PhD, of the Hospital General Universitario Dr. Balmis, Alicante, Spain, and her colleagues looked at computer-aided detection of advanced colorectal neoplasias in a higher-risk cohort and saw little advantage over standard colonoscopy.
This study, which randomized 3,213 subjects, is the largest to date aimed at learning whether AI can improve the detection of advanced lesions. As in Dr. Hassan’s meta-analysis, the researchers did not see significant differences in the rates of detection for these larger lesions. Nor, in this study, did CADe did improve the global adenoma detection rate among the FIT positive individuals undergoing screening.
The detection rate of advanced colorectal neoplasias (advanced adenoma or advanced serrated polyp) was 34.8% with CADe (95% CI, 32.5%-37.2%) and 34.6% for standard colonoscopy (95% CI, 32.2%-36.9%); adjusted risk ratio, 1.01 [95% CI, 0.92-1.10]. The mean number of advanced colorectal neoplasias detected per colonoscopy was 0.54 for the intervention group, compared with 0.52 for standard care. For all adenomas, the detection rate was 64.2% with CADe vs 62% for controls.
Dr. Rodrigo Jover of the Hospital General Universitario Dr. Balmis, the study’s corresponding author, commented to this news organization that “while CADe systems are able to improve detection of small low-risk lesions, these devices are not yet able to detect more significant high-risk lesions. Therefore, there is still room for improvement if these systems are adequately trained with datasets of large, difficult-to-detect lesions.”
In an editorial comment on the Spanish and Italian studies Dennis Shung, MD, PhD of Yale University in New Haven, Connecticut, concluded that “this recent evidence suggests that CADe systems do not meaningfully improve the detection of larger (≥10 mm) clinically significant polyps. This tempers enthusiasm for CADe but does not negate the clear performance benefit for detecting adenomas of all sizes.”
How to integrate the AI systems into real-world practice is the real challenge ahead, Dr. Shung argued, noting that, in contrast to randomized trials, “several recent real-world studies have found no improvement in [adenoma detection rate] when CADe is deployed.” Lower trust in the systems can result in their underutilization, Dr. Shung argued, while higher trust can lead to overreliance. “How lgorithmic systems partner with clinicians and how these should be designed and refined across heterogeneous systems and contexts are necessary questions that must be explored to minimize disruption and lead to real-world effectiveness.”
Dr. Mangas-Sanjuan’s study was funded by a grant from Medtronic; Part of Dr. Hassan’s meta-analysis was supported by a European Commission grant to one co-author. Drs. Shung, Hassan, Manguas-Sanjuan, and Jover declared no financial conflicts of interest.
according to results from a large meta-analysis of randomized controlled trials.
But while adenoma detection rates increased by nearly 25%, compared with conventional care, the AI-guided procedures were also associated with an increase in unnecessary removal of non-neoplastic polyps. Little effect was seen on the detection of larger, advanced lesions.
The findings, published in Annals of Internal Medicine, are likely to change clinical guidelines in favor of AI-assisted procedures, said Cesare Hassan, MD, PhD, of Humanitas Research Hospital and University in Milan, Italy.
For their research, Dr. Hassan and his colleagues looked at results from 21 trials randomizing more than 18,000 patients to colonoscopy with computer-aided detection (CADe) or standard colonoscopy. Colonoscopy could be carried out for screening, surveillance, or diagnostic purposes. The included trials, which were all published in 2019 or later, took place in Asia, North America, and Europe. In most of the studies endoscopists were not blinded to treatment allocation.
The adenoma detection rate, or the proportion of individuals undergoing colonoscopy who had at least one adenoma detected and removed, was 44% in the CADe arms, compared with 35.9% assigned to standard care (relative risk [RR], 1.24; 95% CI, 1.16-1.33). The CADe patients also saw more non-neoplastic polyps removed: 0.52 per colonoscopy, compared with 0.34 for standard care. The increased adenoma detection rate appeared to be driven by a 55% decrease in the error or miss rate of adenomas at per-polyp analysis, the investigators wrote in their paper.
CADe did not increase the number of advanced adenomas (defined as greater than 10 mm, with high-grade dysplasia and villous histology) detected per colonoscopy. Rather, the benefit was “mainly limited to increased detection of diminutive (≤5 mm) adenomas,” the investigators wrote. Dr. Hassan commented that the lack of benefit for detecting larger adenomas was expected, as these are easier for endoscopists to identify visually.
The key limitation of the meta-analysis, Dr. Hassan said, was the fact that endoscopists in the studies could not be blinded. “We can assume there is a risk of bias in our estimates — that is why we describe the quality of evidence as low or moderate, never high. Through randomization we can control other aspects, especially the prevalence of disease, which avoids a scenario in which the endoscopist opts to treat riskier patients with CADe.” But the possibility of a change in the endoscopist’s performance when using these systems cannot be excluded.
Dr. Hassan commented that quantifying the risks, and costs, of overtreatment linked to CADe would require more investigation. “Any time I remove a polyp there’s a risk of perforation and bleeding,” he noted, though most of the unnecessary resections seen in the meta-analysis were of small hyperplastic polyps considered to be low risk for complications. Use of CADe was associated with only slight increases in procedure time, the investigators found.
In a multicenter Spanish study also published in Annals of Internal Medicine, Carolina Mangas-Sanjuan, MD, PhD, of the Hospital General Universitario Dr. Balmis, Alicante, Spain, and her colleagues looked at computer-aided detection of advanced colorectal neoplasias in a higher-risk cohort and saw little advantage over standard colonoscopy.
This study, which randomized 3,213 subjects, is the largest to date aimed at learning whether AI can improve the detection of advanced lesions. As in Dr. Hassan’s meta-analysis, the researchers did not see significant differences in the rates of detection for these larger lesions. Nor, in this study, did CADe did improve the global adenoma detection rate among the FIT positive individuals undergoing screening.
The detection rate of advanced colorectal neoplasias (advanced adenoma or advanced serrated polyp) was 34.8% with CADe (95% CI, 32.5%-37.2%) and 34.6% for standard colonoscopy (95% CI, 32.2%-36.9%); adjusted risk ratio, 1.01 [95% CI, 0.92-1.10]. The mean number of advanced colorectal neoplasias detected per colonoscopy was 0.54 for the intervention group, compared with 0.52 for standard care. For all adenomas, the detection rate was 64.2% with CADe vs 62% for controls.
Dr. Rodrigo Jover of the Hospital General Universitario Dr. Balmis, the study’s corresponding author, commented to this news organization that “while CADe systems are able to improve detection of small low-risk lesions, these devices are not yet able to detect more significant high-risk lesions. Therefore, there is still room for improvement if these systems are adequately trained with datasets of large, difficult-to-detect lesions.”
In an editorial comment on the Spanish and Italian studies Dennis Shung, MD, PhD of Yale University in New Haven, Connecticut, concluded that “this recent evidence suggests that CADe systems do not meaningfully improve the detection of larger (≥10 mm) clinically significant polyps. This tempers enthusiasm for CADe but does not negate the clear performance benefit for detecting adenomas of all sizes.”
How to integrate the AI systems into real-world practice is the real challenge ahead, Dr. Shung argued, noting that, in contrast to randomized trials, “several recent real-world studies have found no improvement in [adenoma detection rate] when CADe is deployed.” Lower trust in the systems can result in their underutilization, Dr. Shung argued, while higher trust can lead to overreliance. “How lgorithmic systems partner with clinicians and how these should be designed and refined across heterogeneous systems and contexts are necessary questions that must be explored to minimize disruption and lead to real-world effectiveness.”
Dr. Mangas-Sanjuan’s study was funded by a grant from Medtronic; Part of Dr. Hassan’s meta-analysis was supported by a European Commission grant to one co-author. Drs. Shung, Hassan, Manguas-Sanjuan, and Jover declared no financial conflicts of interest.
according to results from a large meta-analysis of randomized controlled trials.
But while adenoma detection rates increased by nearly 25%, compared with conventional care, the AI-guided procedures were also associated with an increase in unnecessary removal of non-neoplastic polyps. Little effect was seen on the detection of larger, advanced lesions.
The findings, published in Annals of Internal Medicine, are likely to change clinical guidelines in favor of AI-assisted procedures, said Cesare Hassan, MD, PhD, of Humanitas Research Hospital and University in Milan, Italy.
For their research, Dr. Hassan and his colleagues looked at results from 21 trials randomizing more than 18,000 patients to colonoscopy with computer-aided detection (CADe) or standard colonoscopy. Colonoscopy could be carried out for screening, surveillance, or diagnostic purposes. The included trials, which were all published in 2019 or later, took place in Asia, North America, and Europe. In most of the studies endoscopists were not blinded to treatment allocation.
The adenoma detection rate, or the proportion of individuals undergoing colonoscopy who had at least one adenoma detected and removed, was 44% in the CADe arms, compared with 35.9% assigned to standard care (relative risk [RR], 1.24; 95% CI, 1.16-1.33). The CADe patients also saw more non-neoplastic polyps removed: 0.52 per colonoscopy, compared with 0.34 for standard care. The increased adenoma detection rate appeared to be driven by a 55% decrease in the error or miss rate of adenomas at per-polyp analysis, the investigators wrote in their paper.
CADe did not increase the number of advanced adenomas (defined as greater than 10 mm, with high-grade dysplasia and villous histology) detected per colonoscopy. Rather, the benefit was “mainly limited to increased detection of diminutive (≤5 mm) adenomas,” the investigators wrote. Dr. Hassan commented that the lack of benefit for detecting larger adenomas was expected, as these are easier for endoscopists to identify visually.
The key limitation of the meta-analysis, Dr. Hassan said, was the fact that endoscopists in the studies could not be blinded. “We can assume there is a risk of bias in our estimates — that is why we describe the quality of evidence as low or moderate, never high. Through randomization we can control other aspects, especially the prevalence of disease, which avoids a scenario in which the endoscopist opts to treat riskier patients with CADe.” But the possibility of a change in the endoscopist’s performance when using these systems cannot be excluded.
Dr. Hassan commented that quantifying the risks, and costs, of overtreatment linked to CADe would require more investigation. “Any time I remove a polyp there’s a risk of perforation and bleeding,” he noted, though most of the unnecessary resections seen in the meta-analysis were of small hyperplastic polyps considered to be low risk for complications. Use of CADe was associated with only slight increases in procedure time, the investigators found.
In a multicenter Spanish study also published in Annals of Internal Medicine, Carolina Mangas-Sanjuan, MD, PhD, of the Hospital General Universitario Dr. Balmis, Alicante, Spain, and her colleagues looked at computer-aided detection of advanced colorectal neoplasias in a higher-risk cohort and saw little advantage over standard colonoscopy.
This study, which randomized 3,213 subjects, is the largest to date aimed at learning whether AI can improve the detection of advanced lesions. As in Dr. Hassan’s meta-analysis, the researchers did not see significant differences in the rates of detection for these larger lesions. Nor, in this study, did CADe did improve the global adenoma detection rate among the FIT positive individuals undergoing screening.
The detection rate of advanced colorectal neoplasias (advanced adenoma or advanced serrated polyp) was 34.8% with CADe (95% CI, 32.5%-37.2%) and 34.6% for standard colonoscopy (95% CI, 32.2%-36.9%); adjusted risk ratio, 1.01 [95% CI, 0.92-1.10]. The mean number of advanced colorectal neoplasias detected per colonoscopy was 0.54 for the intervention group, compared with 0.52 for standard care. For all adenomas, the detection rate was 64.2% with CADe vs 62% for controls.
Dr. Rodrigo Jover of the Hospital General Universitario Dr. Balmis, the study’s corresponding author, commented to this news organization that “while CADe systems are able to improve detection of small low-risk lesions, these devices are not yet able to detect more significant high-risk lesions. Therefore, there is still room for improvement if these systems are adequately trained with datasets of large, difficult-to-detect lesions.”
In an editorial comment on the Spanish and Italian studies Dennis Shung, MD, PhD of Yale University in New Haven, Connecticut, concluded that “this recent evidence suggests that CADe systems do not meaningfully improve the detection of larger (≥10 mm) clinically significant polyps. This tempers enthusiasm for CADe but does not negate the clear performance benefit for detecting adenomas of all sizes.”
How to integrate the AI systems into real-world practice is the real challenge ahead, Dr. Shung argued, noting that, in contrast to randomized trials, “several recent real-world studies have found no improvement in [adenoma detection rate] when CADe is deployed.” Lower trust in the systems can result in their underutilization, Dr. Shung argued, while higher trust can lead to overreliance. “How lgorithmic systems partner with clinicians and how these should be designed and refined across heterogeneous systems and contexts are necessary questions that must be explored to minimize disruption and lead to real-world effectiveness.”
Dr. Mangas-Sanjuan’s study was funded by a grant from Medtronic; Part of Dr. Hassan’s meta-analysis was supported by a European Commission grant to one co-author. Drs. Shung, Hassan, Manguas-Sanjuan, and Jover declared no financial conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
Clinician responsibilities during times of geopolitical conflict
In the realm of clinical psychology and psychiatry, our primary duty and commitment is (and should be) to the well-being of our patients. Yet, as we find ourselves in an era marked by escalating geopolitical conflict, such as the Israel-Hamas war, probably more aptly titled the Israeli-Hamas-Hezbollah-Houthi war (a clarification that elucidates a later point), clinicians are increasingly confronted with ethical dilemmas that extend far beyond what is outlined in our code of ethics.
These challenges are not only impacting us on a personal level but are also spilling over into our professional lives, creating a divisive and non-collegial environment within the healthcare community. We commit to “do no harm” when delivering care and yet we are doing harm to one another as colleagues.
We are no strangers to the complexities of human behavior and the intricate tapestry of emotions that are involved with our professional work. However, the current geopolitical landscape has added an extra layer of difficulty to our already taxing professional lives. We are, after all, human first with unconscious drives that govern how we negotiate cognitive dissonance and our need for the illusion of absolute justice as Yuval Noah Harari explains in a recent podcast.
Humans are notoriously bad at holding the multiplicity of experience in mind and various (often competing narratives) that impede the capacity for nuanced thinking. We would like to believe we are better and more capable than the average person in doing so, but divisiveness in our profession has become disturbingly pronounced, making it essential for us to carve out reflective space, more than ever.
The personal and professional divide
Geopolitical conflicts like the current war have a unique capacity to ignite strong emotions and deeply held convictions. It’s not hard to quickly become embroiled in passionate and engaged debate.
While discussion and discourse are healthy, these are bleeding into professional spheres, creating rifts within our clinical communities and contributing to a culture where not everyone feels safe. Look at any professional listserv in medicine or psychology and you will find the evidence. It should be an immediate call to action that we need to be fostering a different type of environment.
The impact of divisiveness is profound, hindering opportunities for collaboration, mentorship, and the free exchange of ideas among clinicians. It may lead to misunderstandings, mistrust, and an erosion of the support systems we rely on, ultimately diverting energy away from the pursuit of providing quality patient-care.
Balancing obligations and limits
Because of the inherent power differential that accompanies being in a provider role (physician and psychologist alike), we have a social and moral responsibility to be mindful of what we share – for the sake of humanity. There is an implicit assumption that a provider’s guidance should be adhered to and respected. In other words, words carry tremendous weight and deeply matter, and people in the general public ascribe significant meaning to messages put out by professionals.
When providers steer from their lanes of professional expertise to provide the general public with opinions or recommendations on nonmedical topics, problematic precedents can be set. We may be doing people a disservice.
Unfortunately, I have heard several anecdotes about clinicians who spend their patient’s time in session pushing their own ideological agendas. The patient-provider relationship is founded on principles of trust, empathy, and collaboration, with the primary goal of improving overall well-being and addressing a specific presenting problem. Of course, issues emerge that need to be addressed outside of the initial scope of treatment, an inherent part of the process. However, a grave concern emerges when clinicians initiate dialogue that is not meaningful to a patient, disclose and discuss their personal ideologies, or put pressure on patients to explain their beliefs in an attempt to change the patients’ minds.
Clinicians pushing their own agenda during patient sessions is antithetical to the objectives of psychotherapy and compromises the therapeutic alliance by diverting the focus of care in a way that serves the clinician rather than the client. It is quite the opposite of the patient-centered care that we strive for in training and practice.
Even within one’s theoretical professional scope of competence, I have seen the impact of emotions running high during this conflict, and have witnessed trained professionals making light of, or even mocking, hostages and their behavior upon release. These are care providers who could elucidate the complexities of captor-captive dynamics and the impact of trauma for the general public, yet they are contributing to dangerous perceptions and divisiveness.
I have also seen providers justify sexual violence, diminishing survivor and witness testimony due to ideological differences and strong personal beliefs. This is harmful to those impacted and does a disservice to our profession at large. In a helping profession we should strive to support and advocate for anyone who has been maltreated or experienced any form of victimization, violence, or abuse. This should be a professional standard.
As clinicians, we have an ethical obligation to uphold the well-being, autonomy, and dignity of our patients — and humanity. It is crucial to recognize the limits of our expertise and the ethical concerns that can arise in light of geopolitical conflict. How can we balance our duty to provide psychological support while also being cautious about delving into the realms of political analysis, foreign policy, or international relations?
The pitfalls of well-intentioned speaking out
In the age of social media and instant communication, a critical aspect to consider is the role of speaking out. The point I made above, in naming all partaking in the current conflict, speaks to this issue.
As providers and programs, we must be mindful of the inadvertent harm that can arise from making brief, underdeveloped, uninformed, or emotionally charged statements. Expressing opinions without a solid understanding of the historical, cultural, and political nuances of a conflict can contribute to misinformation and further polarization.
Anecdotally, there appears to be some significant degree of bias emerging within professional fields (e.g., psychology, medicine) and an innate calling for providers to “weigh in” as the war continues. Obviously, physicians and psychologists are trained to provide care and to be humanistic and empathic, but the majority do not have expertise in geopolitics or a nuanced awareness of the complexities of the conflict in the Middle East.
While hearts may be in the right place, issuing statements on complicated humanitarian/political situations can inadvertently have unintended and harmful consequences (in terms of antisemitism and islamophobia, increased incidence of hate crimes, and colleagues not feeling safe within professional societies or member organizations).
Unsophisticated, overly simplistic, and reductionistic statements that do not adequately convey nuance will not reflect the range of experience reflected by providers in the field (or the patients we treat). It is essential for clinicians and institutions putting out public statements to engage in deep reflection and utilize discernment. We must recognize that our words carry weight, given our position of influence as treatment providers. To minimize harm, we should seek to provide information that is fair, vetted, and balanced, and encourage open, respectful dialogue rather than asserting definitive positions.
Ultimately, as providers we must strive to seek unity and inclusivity amidst the current challenges. It is important for us to embody a spirit of collaboration during a time demarcated by deep fragmentation.
By acknowledging our limitations, promoting informed discussion, and avoiding the pitfalls of uninformed advocacy, we can contribute to a more compassionate and understanding world, even in the face of the most divisive geopolitical conflicts. We have an obligation to uphold when it comes to ourselves as professionals, and we need to foster healthy, respectful dialogue while maintaining an awareness of our blind spots.
Dr. Feldman is a licensed clinical psychologist in private practice in Miami. She is an adjunct professor in the College of Psychology at Nova Southeastern University, Fort Lauderdale, Fla., where she teaches clinical psychology doctoral students. She is an affiliate of Baptist West Kendall Hospital/FIU Family Medicine Residency Program and serves as president on the board of directors of The Southeast Florida Association for Psychoanalytic Psychology. The opinions expressed by Dr. Feldman are her own and do not represent the institutions with which she is affiliated. She has no disclosures.
In the realm of clinical psychology and psychiatry, our primary duty and commitment is (and should be) to the well-being of our patients. Yet, as we find ourselves in an era marked by escalating geopolitical conflict, such as the Israel-Hamas war, probably more aptly titled the Israeli-Hamas-Hezbollah-Houthi war (a clarification that elucidates a later point), clinicians are increasingly confronted with ethical dilemmas that extend far beyond what is outlined in our code of ethics.
These challenges are not only impacting us on a personal level but are also spilling over into our professional lives, creating a divisive and non-collegial environment within the healthcare community. We commit to “do no harm” when delivering care and yet we are doing harm to one another as colleagues.
We are no strangers to the complexities of human behavior and the intricate tapestry of emotions that are involved with our professional work. However, the current geopolitical landscape has added an extra layer of difficulty to our already taxing professional lives. We are, after all, human first with unconscious drives that govern how we negotiate cognitive dissonance and our need for the illusion of absolute justice as Yuval Noah Harari explains in a recent podcast.
Humans are notoriously bad at holding the multiplicity of experience in mind and various (often competing narratives) that impede the capacity for nuanced thinking. We would like to believe we are better and more capable than the average person in doing so, but divisiveness in our profession has become disturbingly pronounced, making it essential for us to carve out reflective space, more than ever.
The personal and professional divide
Geopolitical conflicts like the current war have a unique capacity to ignite strong emotions and deeply held convictions. It’s not hard to quickly become embroiled in passionate and engaged debate.
While discussion and discourse are healthy, these are bleeding into professional spheres, creating rifts within our clinical communities and contributing to a culture where not everyone feels safe. Look at any professional listserv in medicine or psychology and you will find the evidence. It should be an immediate call to action that we need to be fostering a different type of environment.
The impact of divisiveness is profound, hindering opportunities for collaboration, mentorship, and the free exchange of ideas among clinicians. It may lead to misunderstandings, mistrust, and an erosion of the support systems we rely on, ultimately diverting energy away from the pursuit of providing quality patient-care.
Balancing obligations and limits
Because of the inherent power differential that accompanies being in a provider role (physician and psychologist alike), we have a social and moral responsibility to be mindful of what we share – for the sake of humanity. There is an implicit assumption that a provider’s guidance should be adhered to and respected. In other words, words carry tremendous weight and deeply matter, and people in the general public ascribe significant meaning to messages put out by professionals.
When providers steer from their lanes of professional expertise to provide the general public with opinions or recommendations on nonmedical topics, problematic precedents can be set. We may be doing people a disservice.
Unfortunately, I have heard several anecdotes about clinicians who spend their patient’s time in session pushing their own ideological agendas. The patient-provider relationship is founded on principles of trust, empathy, and collaboration, with the primary goal of improving overall well-being and addressing a specific presenting problem. Of course, issues emerge that need to be addressed outside of the initial scope of treatment, an inherent part of the process. However, a grave concern emerges when clinicians initiate dialogue that is not meaningful to a patient, disclose and discuss their personal ideologies, or put pressure on patients to explain their beliefs in an attempt to change the patients’ minds.
Clinicians pushing their own agenda during patient sessions is antithetical to the objectives of psychotherapy and compromises the therapeutic alliance by diverting the focus of care in a way that serves the clinician rather than the client. It is quite the opposite of the patient-centered care that we strive for in training and practice.
Even within one’s theoretical professional scope of competence, I have seen the impact of emotions running high during this conflict, and have witnessed trained professionals making light of, or even mocking, hostages and their behavior upon release. These are care providers who could elucidate the complexities of captor-captive dynamics and the impact of trauma for the general public, yet they are contributing to dangerous perceptions and divisiveness.
I have also seen providers justify sexual violence, diminishing survivor and witness testimony due to ideological differences and strong personal beliefs. This is harmful to those impacted and does a disservice to our profession at large. In a helping profession we should strive to support and advocate for anyone who has been maltreated or experienced any form of victimization, violence, or abuse. This should be a professional standard.
As clinicians, we have an ethical obligation to uphold the well-being, autonomy, and dignity of our patients — and humanity. It is crucial to recognize the limits of our expertise and the ethical concerns that can arise in light of geopolitical conflict. How can we balance our duty to provide psychological support while also being cautious about delving into the realms of political analysis, foreign policy, or international relations?
The pitfalls of well-intentioned speaking out
In the age of social media and instant communication, a critical aspect to consider is the role of speaking out. The point I made above, in naming all partaking in the current conflict, speaks to this issue.
As providers and programs, we must be mindful of the inadvertent harm that can arise from making brief, underdeveloped, uninformed, or emotionally charged statements. Expressing opinions without a solid understanding of the historical, cultural, and political nuances of a conflict can contribute to misinformation and further polarization.
Anecdotally, there appears to be some significant degree of bias emerging within professional fields (e.g., psychology, medicine) and an innate calling for providers to “weigh in” as the war continues. Obviously, physicians and psychologists are trained to provide care and to be humanistic and empathic, but the majority do not have expertise in geopolitics or a nuanced awareness of the complexities of the conflict in the Middle East.
While hearts may be in the right place, issuing statements on complicated humanitarian/political situations can inadvertently have unintended and harmful consequences (in terms of antisemitism and islamophobia, increased incidence of hate crimes, and colleagues not feeling safe within professional societies or member organizations).
Unsophisticated, overly simplistic, and reductionistic statements that do not adequately convey nuance will not reflect the range of experience reflected by providers in the field (or the patients we treat). It is essential for clinicians and institutions putting out public statements to engage in deep reflection and utilize discernment. We must recognize that our words carry weight, given our position of influence as treatment providers. To minimize harm, we should seek to provide information that is fair, vetted, and balanced, and encourage open, respectful dialogue rather than asserting definitive positions.
Ultimately, as providers we must strive to seek unity and inclusivity amidst the current challenges. It is important for us to embody a spirit of collaboration during a time demarcated by deep fragmentation.
By acknowledging our limitations, promoting informed discussion, and avoiding the pitfalls of uninformed advocacy, we can contribute to a more compassionate and understanding world, even in the face of the most divisive geopolitical conflicts. We have an obligation to uphold when it comes to ourselves as professionals, and we need to foster healthy, respectful dialogue while maintaining an awareness of our blind spots.
Dr. Feldman is a licensed clinical psychologist in private practice in Miami. She is an adjunct professor in the College of Psychology at Nova Southeastern University, Fort Lauderdale, Fla., where she teaches clinical psychology doctoral students. She is an affiliate of Baptist West Kendall Hospital/FIU Family Medicine Residency Program and serves as president on the board of directors of The Southeast Florida Association for Psychoanalytic Psychology. The opinions expressed by Dr. Feldman are her own and do not represent the institutions with which she is affiliated. She has no disclosures.
In the realm of clinical psychology and psychiatry, our primary duty and commitment is (and should be) to the well-being of our patients. Yet, as we find ourselves in an era marked by escalating geopolitical conflict, such as the Israel-Hamas war, probably more aptly titled the Israeli-Hamas-Hezbollah-Houthi war (a clarification that elucidates a later point), clinicians are increasingly confronted with ethical dilemmas that extend far beyond what is outlined in our code of ethics.
These challenges are not only impacting us on a personal level but are also spilling over into our professional lives, creating a divisive and non-collegial environment within the healthcare community. We commit to “do no harm” when delivering care and yet we are doing harm to one another as colleagues.
We are no strangers to the complexities of human behavior and the intricate tapestry of emotions that are involved with our professional work. However, the current geopolitical landscape has added an extra layer of difficulty to our already taxing professional lives. We are, after all, human first with unconscious drives that govern how we negotiate cognitive dissonance and our need for the illusion of absolute justice as Yuval Noah Harari explains in a recent podcast.
Humans are notoriously bad at holding the multiplicity of experience in mind and various (often competing narratives) that impede the capacity for nuanced thinking. We would like to believe we are better and more capable than the average person in doing so, but divisiveness in our profession has become disturbingly pronounced, making it essential for us to carve out reflective space, more than ever.
The personal and professional divide
Geopolitical conflicts like the current war have a unique capacity to ignite strong emotions and deeply held convictions. It’s not hard to quickly become embroiled in passionate and engaged debate.
While discussion and discourse are healthy, these are bleeding into professional spheres, creating rifts within our clinical communities and contributing to a culture where not everyone feels safe. Look at any professional listserv in medicine or psychology and you will find the evidence. It should be an immediate call to action that we need to be fostering a different type of environment.
The impact of divisiveness is profound, hindering opportunities for collaboration, mentorship, and the free exchange of ideas among clinicians. It may lead to misunderstandings, mistrust, and an erosion of the support systems we rely on, ultimately diverting energy away from the pursuit of providing quality patient-care.
Balancing obligations and limits
Because of the inherent power differential that accompanies being in a provider role (physician and psychologist alike), we have a social and moral responsibility to be mindful of what we share – for the sake of humanity. There is an implicit assumption that a provider’s guidance should be adhered to and respected. In other words, words carry tremendous weight and deeply matter, and people in the general public ascribe significant meaning to messages put out by professionals.
When providers steer from their lanes of professional expertise to provide the general public with opinions or recommendations on nonmedical topics, problematic precedents can be set. We may be doing people a disservice.
Unfortunately, I have heard several anecdotes about clinicians who spend their patient’s time in session pushing their own ideological agendas. The patient-provider relationship is founded on principles of trust, empathy, and collaboration, with the primary goal of improving overall well-being and addressing a specific presenting problem. Of course, issues emerge that need to be addressed outside of the initial scope of treatment, an inherent part of the process. However, a grave concern emerges when clinicians initiate dialogue that is not meaningful to a patient, disclose and discuss their personal ideologies, or put pressure on patients to explain their beliefs in an attempt to change the patients’ minds.
Clinicians pushing their own agenda during patient sessions is antithetical to the objectives of psychotherapy and compromises the therapeutic alliance by diverting the focus of care in a way that serves the clinician rather than the client. It is quite the opposite of the patient-centered care that we strive for in training and practice.
Even within one’s theoretical professional scope of competence, I have seen the impact of emotions running high during this conflict, and have witnessed trained professionals making light of, or even mocking, hostages and their behavior upon release. These are care providers who could elucidate the complexities of captor-captive dynamics and the impact of trauma for the general public, yet they are contributing to dangerous perceptions and divisiveness.
I have also seen providers justify sexual violence, diminishing survivor and witness testimony due to ideological differences and strong personal beliefs. This is harmful to those impacted and does a disservice to our profession at large. In a helping profession we should strive to support and advocate for anyone who has been maltreated or experienced any form of victimization, violence, or abuse. This should be a professional standard.
As clinicians, we have an ethical obligation to uphold the well-being, autonomy, and dignity of our patients — and humanity. It is crucial to recognize the limits of our expertise and the ethical concerns that can arise in light of geopolitical conflict. How can we balance our duty to provide psychological support while also being cautious about delving into the realms of political analysis, foreign policy, or international relations?
The pitfalls of well-intentioned speaking out
In the age of social media and instant communication, a critical aspect to consider is the role of speaking out. The point I made above, in naming all partaking in the current conflict, speaks to this issue.
As providers and programs, we must be mindful of the inadvertent harm that can arise from making brief, underdeveloped, uninformed, or emotionally charged statements. Expressing opinions without a solid understanding of the historical, cultural, and political nuances of a conflict can contribute to misinformation and further polarization.
Anecdotally, there appears to be some significant degree of bias emerging within professional fields (e.g., psychology, medicine) and an innate calling for providers to “weigh in” as the war continues. Obviously, physicians and psychologists are trained to provide care and to be humanistic and empathic, but the majority do not have expertise in geopolitics or a nuanced awareness of the complexities of the conflict in the Middle East.
While hearts may be in the right place, issuing statements on complicated humanitarian/political situations can inadvertently have unintended and harmful consequences (in terms of antisemitism and islamophobia, increased incidence of hate crimes, and colleagues not feeling safe within professional societies or member organizations).
Unsophisticated, overly simplistic, and reductionistic statements that do not adequately convey nuance will not reflect the range of experience reflected by providers in the field (or the patients we treat). It is essential for clinicians and institutions putting out public statements to engage in deep reflection and utilize discernment. We must recognize that our words carry weight, given our position of influence as treatment providers. To minimize harm, we should seek to provide information that is fair, vetted, and balanced, and encourage open, respectful dialogue rather than asserting definitive positions.
Ultimately, as providers we must strive to seek unity and inclusivity amidst the current challenges. It is important for us to embody a spirit of collaboration during a time demarcated by deep fragmentation.
By acknowledging our limitations, promoting informed discussion, and avoiding the pitfalls of uninformed advocacy, we can contribute to a more compassionate and understanding world, even in the face of the most divisive geopolitical conflicts. We have an obligation to uphold when it comes to ourselves as professionals, and we need to foster healthy, respectful dialogue while maintaining an awareness of our blind spots.
Dr. Feldman is a licensed clinical psychologist in private practice in Miami. She is an adjunct professor in the College of Psychology at Nova Southeastern University, Fort Lauderdale, Fla., where she teaches clinical psychology doctoral students. She is an affiliate of Baptist West Kendall Hospital/FIU Family Medicine Residency Program and serves as president on the board of directors of The Southeast Florida Association for Psychoanalytic Psychology. The opinions expressed by Dr. Feldman are her own and do not represent the institutions with which she is affiliated. She has no disclosures.
When to skip regional nodal radiation in breast cancer
SAN ANTONIO — There’s a long-standing debate in breast oncology about what to do when positive axillary lymph nodes turn negative after neoadjuvant chemotherapy.
Currently, it’s about a 50/50 split among oncologists, according to breast cancer surgeon Eleftherios P. Mamounas, MD, medical director of the Comprehensive Breast Program at the Orlando Health Cancer Institute in Florida.
Until now, Dr. Mamounas’s own institution has opted for regional irradiation just to be on the safe side, but he said that’s going to change in the wake of a multicenter trial he presented at the San Antonio Breast Cancer Symposium.
Dr. Mamounas led a team that randomized 1556 women equally to either regional nodal irradiation or no nodal irradiation following surgery, which was lumpectomy in just over half the subjects and mastectomy in the rest.
Women were a median of 52 years old. Almost 60% had T2 disease and the rest were split about evenly between T1 and T3 disease. Nearly a quarter of the tumors were triple-negative, and over half were HER2 positive.
In the regional nodal irradiation arm, women who had mastectomies had chest wall irradiation in addition to regional nodal irradiation, while women who underwent lumpectomies had whole breast irradiation with regional nodal irradiation. In the no-irradiation group, mastectomies were followed by observation and lumpectomies by whole breast irradiation alone.
All the women had positive axillary lymph nodes (N1) on needle biopsies at baseline that were found to be free of cancer at surgery (ypN0) following neoadjuvant chemotherapy. Neoadjuvant therapy consisted of at least 8 weeks of chemotherapy plus anti-HER2 therapy for HER2-positive patients.
Dr. Mamounas and colleagues observed no meaningful differences in outcomes between the two groups: 92.7% of women in the nodal irradiation arm and 91.8% in the no-irradiation arm were free from invasive recurrences 5 years after surgery.
Patients in both groups demonstrated similar 5-year disease-free survival and overall survival. The 5-year disease-free survival was 88.5% without and 88.3% with regional nodal irradiation and 5-year overall survival was 94% without and 93.6% with regional nodal irradiation.
The team did not observe study-related deaths or unexpected toxicities. Overall, 6.5% of patients without regional nodal irradiation developed grade 3 toxicity vs. 10% of patients with irradiation. Grade 4 toxicity was rare, occurring in 0.1% of patients in the no-irradiation group vs. 0.5% in the irradiation group.
The trial answers “a very important question,” according to Kate Lathrop, MD, a breast medical oncologist at UT Health San Antonio, who moderated the presentation.
The trial results were “highly awaited” because “we didn’t have the data to make these” decisions, Dr. Lathrop said.
Knowing these patients do just as well without regional nodal irradiation is “going to change a lot of opinions,” said Dr. Lathrop, because we can avoid subjecting patients to unnecessary toxicity, including lymphedema with regional nodal irradiation as well as problems with breast reconstruction after mastectomy.
Because recurrences can still occur after 5 years, Dr. Mamounas’s team will continue to follow the women, but he believes “it’s very unlikely that long-term distant disease-free survival will change.”
Based on the study, “we will omit” regional nodal irradiation for women who fit the study criteria, Dr. Mamounas said.
When asked if women should ask their doctors about skipping regional nodal irradiation, Dr. Mamounas said “absolutely.”
“I think it requires a discussion at this point,” he explained. “Based on the data, it’s a reasonable conclusion that radiotherapy can be avoided” in many cases, such as in lower-stage women with one initially positive node.
Dr. Mamounas said he thinks patients will be interested in the approach “because they are really looking to avoid radiotherapy” if they can.
The work was funded by the National Cancer Institute. Dr. Mamounas has been a consultant and speaker for Genentech, Merck, and an adviser for TerSera Therapeutics, Biotheranostics Inc., and Sanofi. He owns stock in Moderna. Dr. Lathrop is a consultant for Pfizer, GE Healthcare, and Biotheranostics, and a speaker for Biotheranostics.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — There’s a long-standing debate in breast oncology about what to do when positive axillary lymph nodes turn negative after neoadjuvant chemotherapy.
Currently, it’s about a 50/50 split among oncologists, according to breast cancer surgeon Eleftherios P. Mamounas, MD, medical director of the Comprehensive Breast Program at the Orlando Health Cancer Institute in Florida.
Until now, Dr. Mamounas’s own institution has opted for regional irradiation just to be on the safe side, but he said that’s going to change in the wake of a multicenter trial he presented at the San Antonio Breast Cancer Symposium.
Dr. Mamounas led a team that randomized 1556 women equally to either regional nodal irradiation or no nodal irradiation following surgery, which was lumpectomy in just over half the subjects and mastectomy in the rest.
Women were a median of 52 years old. Almost 60% had T2 disease and the rest were split about evenly between T1 and T3 disease. Nearly a quarter of the tumors were triple-negative, and over half were HER2 positive.
In the regional nodal irradiation arm, women who had mastectomies had chest wall irradiation in addition to regional nodal irradiation, while women who underwent lumpectomies had whole breast irradiation with regional nodal irradiation. In the no-irradiation group, mastectomies were followed by observation and lumpectomies by whole breast irradiation alone.
All the women had positive axillary lymph nodes (N1) on needle biopsies at baseline that were found to be free of cancer at surgery (ypN0) following neoadjuvant chemotherapy. Neoadjuvant therapy consisted of at least 8 weeks of chemotherapy plus anti-HER2 therapy for HER2-positive patients.
Dr. Mamounas and colleagues observed no meaningful differences in outcomes between the two groups: 92.7% of women in the nodal irradiation arm and 91.8% in the no-irradiation arm were free from invasive recurrences 5 years after surgery.
Patients in both groups demonstrated similar 5-year disease-free survival and overall survival. The 5-year disease-free survival was 88.5% without and 88.3% with regional nodal irradiation and 5-year overall survival was 94% without and 93.6% with regional nodal irradiation.
The team did not observe study-related deaths or unexpected toxicities. Overall, 6.5% of patients without regional nodal irradiation developed grade 3 toxicity vs. 10% of patients with irradiation. Grade 4 toxicity was rare, occurring in 0.1% of patients in the no-irradiation group vs. 0.5% in the irradiation group.
The trial answers “a very important question,” according to Kate Lathrop, MD, a breast medical oncologist at UT Health San Antonio, who moderated the presentation.
The trial results were “highly awaited” because “we didn’t have the data to make these” decisions, Dr. Lathrop said.
Knowing these patients do just as well without regional nodal irradiation is “going to change a lot of opinions,” said Dr. Lathrop, because we can avoid subjecting patients to unnecessary toxicity, including lymphedema with regional nodal irradiation as well as problems with breast reconstruction after mastectomy.
Because recurrences can still occur after 5 years, Dr. Mamounas’s team will continue to follow the women, but he believes “it’s very unlikely that long-term distant disease-free survival will change.”
Based on the study, “we will omit” regional nodal irradiation for women who fit the study criteria, Dr. Mamounas said.
When asked if women should ask their doctors about skipping regional nodal irradiation, Dr. Mamounas said “absolutely.”
“I think it requires a discussion at this point,” he explained. “Based on the data, it’s a reasonable conclusion that radiotherapy can be avoided” in many cases, such as in lower-stage women with one initially positive node.
Dr. Mamounas said he thinks patients will be interested in the approach “because they are really looking to avoid radiotherapy” if they can.
The work was funded by the National Cancer Institute. Dr. Mamounas has been a consultant and speaker for Genentech, Merck, and an adviser for TerSera Therapeutics, Biotheranostics Inc., and Sanofi. He owns stock in Moderna. Dr. Lathrop is a consultant for Pfizer, GE Healthcare, and Biotheranostics, and a speaker for Biotheranostics.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — There’s a long-standing debate in breast oncology about what to do when positive axillary lymph nodes turn negative after neoadjuvant chemotherapy.
Currently, it’s about a 50/50 split among oncologists, according to breast cancer surgeon Eleftherios P. Mamounas, MD, medical director of the Comprehensive Breast Program at the Orlando Health Cancer Institute in Florida.
Until now, Dr. Mamounas’s own institution has opted for regional irradiation just to be on the safe side, but he said that’s going to change in the wake of a multicenter trial he presented at the San Antonio Breast Cancer Symposium.
Dr. Mamounas led a team that randomized 1556 women equally to either regional nodal irradiation or no nodal irradiation following surgery, which was lumpectomy in just over half the subjects and mastectomy in the rest.
Women were a median of 52 years old. Almost 60% had T2 disease and the rest were split about evenly between T1 and T3 disease. Nearly a quarter of the tumors were triple-negative, and over half were HER2 positive.
In the regional nodal irradiation arm, women who had mastectomies had chest wall irradiation in addition to regional nodal irradiation, while women who underwent lumpectomies had whole breast irradiation with regional nodal irradiation. In the no-irradiation group, mastectomies were followed by observation and lumpectomies by whole breast irradiation alone.
All the women had positive axillary lymph nodes (N1) on needle biopsies at baseline that were found to be free of cancer at surgery (ypN0) following neoadjuvant chemotherapy. Neoadjuvant therapy consisted of at least 8 weeks of chemotherapy plus anti-HER2 therapy for HER2-positive patients.
Dr. Mamounas and colleagues observed no meaningful differences in outcomes between the two groups: 92.7% of women in the nodal irradiation arm and 91.8% in the no-irradiation arm were free from invasive recurrences 5 years after surgery.
Patients in both groups demonstrated similar 5-year disease-free survival and overall survival. The 5-year disease-free survival was 88.5% without and 88.3% with regional nodal irradiation and 5-year overall survival was 94% without and 93.6% with regional nodal irradiation.
The team did not observe study-related deaths or unexpected toxicities. Overall, 6.5% of patients without regional nodal irradiation developed grade 3 toxicity vs. 10% of patients with irradiation. Grade 4 toxicity was rare, occurring in 0.1% of patients in the no-irradiation group vs. 0.5% in the irradiation group.
The trial answers “a very important question,” according to Kate Lathrop, MD, a breast medical oncologist at UT Health San Antonio, who moderated the presentation.
The trial results were “highly awaited” because “we didn’t have the data to make these” decisions, Dr. Lathrop said.
Knowing these patients do just as well without regional nodal irradiation is “going to change a lot of opinions,” said Dr. Lathrop, because we can avoid subjecting patients to unnecessary toxicity, including lymphedema with regional nodal irradiation as well as problems with breast reconstruction after mastectomy.
Because recurrences can still occur after 5 years, Dr. Mamounas’s team will continue to follow the women, but he believes “it’s very unlikely that long-term distant disease-free survival will change.”
Based on the study, “we will omit” regional nodal irradiation for women who fit the study criteria, Dr. Mamounas said.
When asked if women should ask their doctors about skipping regional nodal irradiation, Dr. Mamounas said “absolutely.”
“I think it requires a discussion at this point,” he explained. “Based on the data, it’s a reasonable conclusion that radiotherapy can be avoided” in many cases, such as in lower-stage women with one initially positive node.
Dr. Mamounas said he thinks patients will be interested in the approach “because they are really looking to avoid radiotherapy” if they can.
The work was funded by the National Cancer Institute. Dr. Mamounas has been a consultant and speaker for Genentech, Merck, and an adviser for TerSera Therapeutics, Biotheranostics Inc., and Sanofi. He owns stock in Moderna. Dr. Lathrop is a consultant for Pfizer, GE Healthcare, and Biotheranostics, and a speaker for Biotheranostics.
A version of this article first appeared on Medscape.com.
AT SABCS 2023
What will help ease the financial toll of breast cancer?
SAN ANTONIO — , new survey findings show.
Almost half of patients surveyed reported a “significant” or “catastrophic” financial burden related to their breast cancer care. But patients also found a range of resources helpful for minimizing this burden, including direct assistance programs that reduce the cost of medications, grants from nonprofits that can cover cancer-related expenses, as well as programs that offer free or low-cost transportation to medical appointments.
Financial toxicity remains a “pervasive problem in the breast cancer community and we really need to go to the next step, which is designing patient-centered, patient-facing interventions to make improvements,” Fumiko Chino, MD, with Memorial Sloan Kettering Cancer Center in New York City, said when presenting the survey results at the San Antonio Breast Cancer Symposium.
A growing body of evidence shows that cancer care, especially for breast cancer, can take a heavy financial toll on patients. However, routine screening for financial toxicity is not necessarily a routine part of clinical care, and providers may not know the types of financial assistance patients value most, Dr. Chino explained.
Dr. Chino and colleagues surveyed 1437 women with breast cancer about their level of financial distress as well as the specific interventions or education initiatives they found most helpful.
Most patients (60%) were White, 27% were Hispanic, and 8% Black. Three quarters of patients were on active treatments, 89% had nonmetastatic disease, and 11% had metastatic disease.
Overall, 47% of patients reported a significant or catastrophic financial burden related to their breast cancer diagnosis and care. This burden was higher for those with metastatic disease (61% vs 45%).
Patients assessed 10 strategies for coping with the financial burdens of care. The top-rated interventions included patient assistance programs offered by pharmaceutical or medical test companies, rated highly by 32% of respondents, and grants from nonprofits, rated highly by 31% of respondents. Patients also found financial assistance departments at cancer centers or hospitals helpful (29%); coupons and savings cards to reduce the cost of prescription drugs (28%); and programs that provide free or low-cost transportation to medical appointments (28%).
In terms of education, respondents said having a checklist of questions to ask their oncology team as well as a list of breast cancer-specific financial grants to apply for would be especially helpful when navigating the financial burdens of breast cancer care.
These preferences, however, did vary by race/ethnicity and disease status. Hispanic patients, for instance, found patient assistance programs offered by companies and cancer centers as well as transportation assistance more helpful than other groups.
Patients with metastatic disease found patient assistance programs offered by medical companies particularly helpful compared with patients with nonmetastatic disease. And compared with patients with metastatic disease, those with nonmetastatic breast cancer found assistance through clinical trials and professional medical billing advocates helpful.
This study confirms the high rates of financial burden in women with breast cancer and clearly demonstrates that intervention preferences vary by sociodemographic and clinical characteristics, study discussant Claire C. Conley, PhD, from Georgetown University, Washington, DC, commented.
“This highlights that one size really doesn’t fit all when it comes to those financial burden interventions,” Dr. Conley said. “We need to think about factors at the patient level, the organizational level, and the environment level.”
The study had no commercial funding. Dr. Chino and Dr. Conley have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — , new survey findings show.
Almost half of patients surveyed reported a “significant” or “catastrophic” financial burden related to their breast cancer care. But patients also found a range of resources helpful for minimizing this burden, including direct assistance programs that reduce the cost of medications, grants from nonprofits that can cover cancer-related expenses, as well as programs that offer free or low-cost transportation to medical appointments.
Financial toxicity remains a “pervasive problem in the breast cancer community and we really need to go to the next step, which is designing patient-centered, patient-facing interventions to make improvements,” Fumiko Chino, MD, with Memorial Sloan Kettering Cancer Center in New York City, said when presenting the survey results at the San Antonio Breast Cancer Symposium.
A growing body of evidence shows that cancer care, especially for breast cancer, can take a heavy financial toll on patients. However, routine screening for financial toxicity is not necessarily a routine part of clinical care, and providers may not know the types of financial assistance patients value most, Dr. Chino explained.
Dr. Chino and colleagues surveyed 1437 women with breast cancer about their level of financial distress as well as the specific interventions or education initiatives they found most helpful.
Most patients (60%) were White, 27% were Hispanic, and 8% Black. Three quarters of patients were on active treatments, 89% had nonmetastatic disease, and 11% had metastatic disease.
Overall, 47% of patients reported a significant or catastrophic financial burden related to their breast cancer diagnosis and care. This burden was higher for those with metastatic disease (61% vs 45%).
Patients assessed 10 strategies for coping with the financial burdens of care. The top-rated interventions included patient assistance programs offered by pharmaceutical or medical test companies, rated highly by 32% of respondents, and grants from nonprofits, rated highly by 31% of respondents. Patients also found financial assistance departments at cancer centers or hospitals helpful (29%); coupons and savings cards to reduce the cost of prescription drugs (28%); and programs that provide free or low-cost transportation to medical appointments (28%).
In terms of education, respondents said having a checklist of questions to ask their oncology team as well as a list of breast cancer-specific financial grants to apply for would be especially helpful when navigating the financial burdens of breast cancer care.
These preferences, however, did vary by race/ethnicity and disease status. Hispanic patients, for instance, found patient assistance programs offered by companies and cancer centers as well as transportation assistance more helpful than other groups.
Patients with metastatic disease found patient assistance programs offered by medical companies particularly helpful compared with patients with nonmetastatic disease. And compared with patients with metastatic disease, those with nonmetastatic breast cancer found assistance through clinical trials and professional medical billing advocates helpful.
This study confirms the high rates of financial burden in women with breast cancer and clearly demonstrates that intervention preferences vary by sociodemographic and clinical characteristics, study discussant Claire C. Conley, PhD, from Georgetown University, Washington, DC, commented.
“This highlights that one size really doesn’t fit all when it comes to those financial burden interventions,” Dr. Conley said. “We need to think about factors at the patient level, the organizational level, and the environment level.”
The study had no commercial funding. Dr. Chino and Dr. Conley have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — , new survey findings show.
Almost half of patients surveyed reported a “significant” or “catastrophic” financial burden related to their breast cancer care. But patients also found a range of resources helpful for minimizing this burden, including direct assistance programs that reduce the cost of medications, grants from nonprofits that can cover cancer-related expenses, as well as programs that offer free or low-cost transportation to medical appointments.
Financial toxicity remains a “pervasive problem in the breast cancer community and we really need to go to the next step, which is designing patient-centered, patient-facing interventions to make improvements,” Fumiko Chino, MD, with Memorial Sloan Kettering Cancer Center in New York City, said when presenting the survey results at the San Antonio Breast Cancer Symposium.
A growing body of evidence shows that cancer care, especially for breast cancer, can take a heavy financial toll on patients. However, routine screening for financial toxicity is not necessarily a routine part of clinical care, and providers may not know the types of financial assistance patients value most, Dr. Chino explained.
Dr. Chino and colleagues surveyed 1437 women with breast cancer about their level of financial distress as well as the specific interventions or education initiatives they found most helpful.
Most patients (60%) were White, 27% were Hispanic, and 8% Black. Three quarters of patients were on active treatments, 89% had nonmetastatic disease, and 11% had metastatic disease.
Overall, 47% of patients reported a significant or catastrophic financial burden related to their breast cancer diagnosis and care. This burden was higher for those with metastatic disease (61% vs 45%).
Patients assessed 10 strategies for coping with the financial burdens of care. The top-rated interventions included patient assistance programs offered by pharmaceutical or medical test companies, rated highly by 32% of respondents, and grants from nonprofits, rated highly by 31% of respondents. Patients also found financial assistance departments at cancer centers or hospitals helpful (29%); coupons and savings cards to reduce the cost of prescription drugs (28%); and programs that provide free or low-cost transportation to medical appointments (28%).
In terms of education, respondents said having a checklist of questions to ask their oncology team as well as a list of breast cancer-specific financial grants to apply for would be especially helpful when navigating the financial burdens of breast cancer care.
These preferences, however, did vary by race/ethnicity and disease status. Hispanic patients, for instance, found patient assistance programs offered by companies and cancer centers as well as transportation assistance more helpful than other groups.
Patients with metastatic disease found patient assistance programs offered by medical companies particularly helpful compared with patients with nonmetastatic disease. And compared with patients with metastatic disease, those with nonmetastatic breast cancer found assistance through clinical trials and professional medical billing advocates helpful.
This study confirms the high rates of financial burden in women with breast cancer and clearly demonstrates that intervention preferences vary by sociodemographic and clinical characteristics, study discussant Claire C. Conley, PhD, from Georgetown University, Washington, DC, commented.
“This highlights that one size really doesn’t fit all when it comes to those financial burden interventions,” Dr. Conley said. “We need to think about factors at the patient level, the organizational level, and the environment level.”
The study had no commercial funding. Dr. Chino and Dr. Conley have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM SABCS 2023
Antihypertensives show similar long-term mortality rates
Long-term data showed negligible differences in mortality among hypertensive adults treated with thiazide-type diuretics, calcium channel blockers, or angiotensin-converting enzyme inhibitors in a review of nearly 33,000 individuals published in JAMA Network Open.
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study was designed to compare initial antihypertensive treatments with a calcium channel blocker (CCB; amlodipine), an angiotensin-converting enzyme (ACE) inhibitor (lisinopril) or an alpha-blocker (doxazosin), and a thiazide-type diuretic (chlorthalidone).
The composite primary outcome was fatal coronary heart disease (CHD) or nonfatal myocardial infarction (MI), but long-term data were lacking, wrote Jose-Miguel Yamal, PhD, of University of Texas Health Science Center at Houston, and colleagues. A previous study with 8-13 years of follow-up showed no significant differences in mortality between the treatment groups, the researchers noted.
In the current study, a prespecified secondary analysis of ALLHAT, the researchers added 11 more years of data for a total of 19-24 years of follow-up after randomization.
In the original ALLHAT, 32,804 adults aged 55 years and older with a diagnosis of hypertension and at least one additional coronary heart disease risk factor were followed for 4-8 years for all-cause mortality. A subgroup of 22,754 were followed for fatal or nonfatal cardiovascular disease (CVD) for a mean of 13.7 years, with a maximum of 23.9 years.
The study occurred from Feb. 23, 1994, to Dec. 31, 2017. The participants were randomized to receive a thiazide-type diuretic (15,002 patients), a CCB (8,898 patients), or an ACE inhibitor (8,904 patients).
The primary outcome was CVD mortality; secondary outcomes included all-cause mortality, combined fatal and nonfatal CVD (CVD morbidity), and both morbidity and mortality for coronary heart disease, stroke, heart failure, end-stage renal disease, and cancer.
At 23 years, CVD mortality rates per 100 persons were 23.7, 21.6, and 23.8 in the diuretic, CCB, and ACE inhibitor groups, respectively. The adjusted hazard ratios were 0.97 for CCB vs. diuretics and 1.06 for ACE inhibitors vs. diuretics.
Although the risk of stroke mortality and of combined fatal and nonfatal hospitalized stroke was higher in the ACE inhibitor group compared with the diuretic group (adjusted hazard ratios 1.19 and 1.11, respectively), this increase was no longer significant after adjustment for multiple comparisons. “In contrast to the in-trial and 8-year to 13-year analyses, we now observed that the lisinopril group had an increased risk of kidney disease mortality that emerged after approximately 13 years after randomization, but this effect was attenuated after adjustment for baseline variables,” the researchers wrote in their discussion.
The findings were limited by several factors including the potential effect of unblinding if participants stopped the randomized drug, and by the lack of morbidity and mortality data on Canadian participants, Veterans Affairs participants, and those with no Medicare number, the researchers noted. Other limitations included the lack of data on posttrial medication use, blood pressure, and laboratory findings, they said.
However, the results over the follow-up period of up to 23 years supported those of the larger ALLHAT study, with similar outcomes among the drugs, and with 11 years of passive follow-up, “the results for lisinopril vs. chlorthalidone for stroke and stroke mortality are almost the same,” they concluded.
Findings support current practice, but new drug data are needed
The current study was important to determine whether there was a significant difference in long-term morbidity and mortality between patients treated with thiazide diuretics, calcium channel blockers and ACE inhibitors, Noel Deep, MD, said in an interview.
“Previously reported data had indicated no significant differences between patients randomized to one of these three classes of antihypertensive medications during the trial period or at 8-13 years post trial,” said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep is chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
“This study reinforces the previously noted benefits of the three classes of antihypertensive medications, as well as the higher rates of cardiovascular disease and stroke in the ACE inhibitor arm,” he said.
In clinical practice, the results suggest that thiazide diuretics should be considered first-line agents for management of hypertension based on their noninferiority compared with ACE inhibitors and CCBs, and lower risk of stroke compared with ACE inhibitors, Dr. Deep said in an interview. “All three classes of antihypertensive medications are equally efficacious in blood pressure control and preventing all-cause mortality,” he said.
More research is needed in the wake of the introduction of other classes of antihypertensives since the original ALLHAT trial, Dr. Deep said. “It would be beneficial to assess the relative benefit/risks of those medications compared to the thiazide diuretics, and I would also look at studies comparing beta blockers to the thiazide diuretics,” he said. The question remains as to whether outcomes were affected by patients’ use of other classes of antihypertensives after the trial period, he said.
The study was supported by the National Institute on Aging of the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the editorial advisory board of Internal Medicine News.
Long-term data showed negligible differences in mortality among hypertensive adults treated with thiazide-type diuretics, calcium channel blockers, or angiotensin-converting enzyme inhibitors in a review of nearly 33,000 individuals published in JAMA Network Open.
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study was designed to compare initial antihypertensive treatments with a calcium channel blocker (CCB; amlodipine), an angiotensin-converting enzyme (ACE) inhibitor (lisinopril) or an alpha-blocker (doxazosin), and a thiazide-type diuretic (chlorthalidone).
The composite primary outcome was fatal coronary heart disease (CHD) or nonfatal myocardial infarction (MI), but long-term data were lacking, wrote Jose-Miguel Yamal, PhD, of University of Texas Health Science Center at Houston, and colleagues. A previous study with 8-13 years of follow-up showed no significant differences in mortality between the treatment groups, the researchers noted.
In the current study, a prespecified secondary analysis of ALLHAT, the researchers added 11 more years of data for a total of 19-24 years of follow-up after randomization.
In the original ALLHAT, 32,804 adults aged 55 years and older with a diagnosis of hypertension and at least one additional coronary heart disease risk factor were followed for 4-8 years for all-cause mortality. A subgroup of 22,754 were followed for fatal or nonfatal cardiovascular disease (CVD) for a mean of 13.7 years, with a maximum of 23.9 years.
The study occurred from Feb. 23, 1994, to Dec. 31, 2017. The participants were randomized to receive a thiazide-type diuretic (15,002 patients), a CCB (8,898 patients), or an ACE inhibitor (8,904 patients).
The primary outcome was CVD mortality; secondary outcomes included all-cause mortality, combined fatal and nonfatal CVD (CVD morbidity), and both morbidity and mortality for coronary heart disease, stroke, heart failure, end-stage renal disease, and cancer.
At 23 years, CVD mortality rates per 100 persons were 23.7, 21.6, and 23.8 in the diuretic, CCB, and ACE inhibitor groups, respectively. The adjusted hazard ratios were 0.97 for CCB vs. diuretics and 1.06 for ACE inhibitors vs. diuretics.
Although the risk of stroke mortality and of combined fatal and nonfatal hospitalized stroke was higher in the ACE inhibitor group compared with the diuretic group (adjusted hazard ratios 1.19 and 1.11, respectively), this increase was no longer significant after adjustment for multiple comparisons. “In contrast to the in-trial and 8-year to 13-year analyses, we now observed that the lisinopril group had an increased risk of kidney disease mortality that emerged after approximately 13 years after randomization, but this effect was attenuated after adjustment for baseline variables,” the researchers wrote in their discussion.
The findings were limited by several factors including the potential effect of unblinding if participants stopped the randomized drug, and by the lack of morbidity and mortality data on Canadian participants, Veterans Affairs participants, and those with no Medicare number, the researchers noted. Other limitations included the lack of data on posttrial medication use, blood pressure, and laboratory findings, they said.
However, the results over the follow-up period of up to 23 years supported those of the larger ALLHAT study, with similar outcomes among the drugs, and with 11 years of passive follow-up, “the results for lisinopril vs. chlorthalidone for stroke and stroke mortality are almost the same,” they concluded.
Findings support current practice, but new drug data are needed
The current study was important to determine whether there was a significant difference in long-term morbidity and mortality between patients treated with thiazide diuretics, calcium channel blockers and ACE inhibitors, Noel Deep, MD, said in an interview.
“Previously reported data had indicated no significant differences between patients randomized to one of these three classes of antihypertensive medications during the trial period or at 8-13 years post trial,” said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep is chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
“This study reinforces the previously noted benefits of the three classes of antihypertensive medications, as well as the higher rates of cardiovascular disease and stroke in the ACE inhibitor arm,” he said.
In clinical practice, the results suggest that thiazide diuretics should be considered first-line agents for management of hypertension based on their noninferiority compared with ACE inhibitors and CCBs, and lower risk of stroke compared with ACE inhibitors, Dr. Deep said in an interview. “All three classes of antihypertensive medications are equally efficacious in blood pressure control and preventing all-cause mortality,” he said.
More research is needed in the wake of the introduction of other classes of antihypertensives since the original ALLHAT trial, Dr. Deep said. “It would be beneficial to assess the relative benefit/risks of those medications compared to the thiazide diuretics, and I would also look at studies comparing beta blockers to the thiazide diuretics,” he said. The question remains as to whether outcomes were affected by patients’ use of other classes of antihypertensives after the trial period, he said.
The study was supported by the National Institute on Aging of the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the editorial advisory board of Internal Medicine News.
Long-term data showed negligible differences in mortality among hypertensive adults treated with thiazide-type diuretics, calcium channel blockers, or angiotensin-converting enzyme inhibitors in a review of nearly 33,000 individuals published in JAMA Network Open.
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study was designed to compare initial antihypertensive treatments with a calcium channel blocker (CCB; amlodipine), an angiotensin-converting enzyme (ACE) inhibitor (lisinopril) or an alpha-blocker (doxazosin), and a thiazide-type diuretic (chlorthalidone).
The composite primary outcome was fatal coronary heart disease (CHD) or nonfatal myocardial infarction (MI), but long-term data were lacking, wrote Jose-Miguel Yamal, PhD, of University of Texas Health Science Center at Houston, and colleagues. A previous study with 8-13 years of follow-up showed no significant differences in mortality between the treatment groups, the researchers noted.
In the current study, a prespecified secondary analysis of ALLHAT, the researchers added 11 more years of data for a total of 19-24 years of follow-up after randomization.
In the original ALLHAT, 32,804 adults aged 55 years and older with a diagnosis of hypertension and at least one additional coronary heart disease risk factor were followed for 4-8 years for all-cause mortality. A subgroup of 22,754 were followed for fatal or nonfatal cardiovascular disease (CVD) for a mean of 13.7 years, with a maximum of 23.9 years.
The study occurred from Feb. 23, 1994, to Dec. 31, 2017. The participants were randomized to receive a thiazide-type diuretic (15,002 patients), a CCB (8,898 patients), or an ACE inhibitor (8,904 patients).
The primary outcome was CVD mortality; secondary outcomes included all-cause mortality, combined fatal and nonfatal CVD (CVD morbidity), and both morbidity and mortality for coronary heart disease, stroke, heart failure, end-stage renal disease, and cancer.
At 23 years, CVD mortality rates per 100 persons were 23.7, 21.6, and 23.8 in the diuretic, CCB, and ACE inhibitor groups, respectively. The adjusted hazard ratios were 0.97 for CCB vs. diuretics and 1.06 for ACE inhibitors vs. diuretics.
Although the risk of stroke mortality and of combined fatal and nonfatal hospitalized stroke was higher in the ACE inhibitor group compared with the diuretic group (adjusted hazard ratios 1.19 and 1.11, respectively), this increase was no longer significant after adjustment for multiple comparisons. “In contrast to the in-trial and 8-year to 13-year analyses, we now observed that the lisinopril group had an increased risk of kidney disease mortality that emerged after approximately 13 years after randomization, but this effect was attenuated after adjustment for baseline variables,” the researchers wrote in their discussion.
The findings were limited by several factors including the potential effect of unblinding if participants stopped the randomized drug, and by the lack of morbidity and mortality data on Canadian participants, Veterans Affairs participants, and those with no Medicare number, the researchers noted. Other limitations included the lack of data on posttrial medication use, blood pressure, and laboratory findings, they said.
However, the results over the follow-up period of up to 23 years supported those of the larger ALLHAT study, with similar outcomes among the drugs, and with 11 years of passive follow-up, “the results for lisinopril vs. chlorthalidone for stroke and stroke mortality are almost the same,” they concluded.
Findings support current practice, but new drug data are needed
The current study was important to determine whether there was a significant difference in long-term morbidity and mortality between patients treated with thiazide diuretics, calcium channel blockers and ACE inhibitors, Noel Deep, MD, said in an interview.
“Previously reported data had indicated no significant differences between patients randomized to one of these three classes of antihypertensive medications during the trial period or at 8-13 years post trial,” said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep is chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
“This study reinforces the previously noted benefits of the three classes of antihypertensive medications, as well as the higher rates of cardiovascular disease and stroke in the ACE inhibitor arm,” he said.
In clinical practice, the results suggest that thiazide diuretics should be considered first-line agents for management of hypertension based on their noninferiority compared with ACE inhibitors and CCBs, and lower risk of stroke compared with ACE inhibitors, Dr. Deep said in an interview. “All three classes of antihypertensive medications are equally efficacious in blood pressure control and preventing all-cause mortality,” he said.
More research is needed in the wake of the introduction of other classes of antihypertensives since the original ALLHAT trial, Dr. Deep said. “It would be beneficial to assess the relative benefit/risks of those medications compared to the thiazide diuretics, and I would also look at studies comparing beta blockers to the thiazide diuretics,” he said. The question remains as to whether outcomes were affected by patients’ use of other classes of antihypertensives after the trial period, he said.
The study was supported by the National Institute on Aging of the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the editorial advisory board of Internal Medicine News.
FROM JAMA NETWORK OPEN
Poverty tied to poor cognition in patients with epilepsy
ORLANDO — , early research suggests.
Seniors with epilepsy present with multiple comorbidities, including, for example, hypertension and diabetes, and they are at increased risk of developing dementia, said study investigator Anny Reyes, PhD, a postdoctoral scholar at the University of California at San Diego.
Past research has shown neighborhood disadvantage is associated with numerous adverse health outcomes, including an increased risk for developing Alzheimer’s disease and related dementias (ADRD).
“We already know epilepsy on its own increases risks for dementia, and when you add disadvantaged to that, it’s going to increase the risk even more,” said Dr. Reyes.
Neurologists should ask their older patients with epilepsy, many of whom live alone, about food insecurity and access to resources “not just within the hospital system but also within their community,” she said.
The findings were presented at the annual meeting of the American Epilepsy Society.
Proxy Measure of Disadvantage
The incidence and prevalence of epilepsy increases with age. Older adults represent the fastest growing segment of individuals with epilepsy, said Dr. Reyes.
The new study included 40 patients with focal epilepsy, average age 67 years, from three areas: San Diego, California; Madison, Wisconsin; and Cleveland, Ohio.
Researchers collected clinical and sociodemographic information as well as vascular biomarkers. They also gathered individual-level data, including income, parental education levels, details on childhood upbringing, etc.
Using residential addresses, investigators determined the area deprivation index (ADI) value for study participants. The ADI is a proxy measure for neighborhood-level socioeconomic disadvantage that captures factors such a poverty, employment, housing, and education opportunities.
ADI values range from 1 to 10, with a higher number indicating greater neighborhood disadvantage. About 30% of the cohort had an ADI decile greater than 6.
Researchers divided subjects into Most Disadvantaged (ADI greater than 7) and Least Disadvantaged (AD 7 or less). The two groups were similar with regard to age, education level, and race/ethnicity.
But those from the most disadvantaged areas were younger, taking more antiseizure medications, had fewer years of education, lower levels of father’s education, less personal and family income, and were less likely to be diagnosed with hypertension.
Study subjects completed neuropsychological testing, including:
- Measures of learning (Rey Auditory Verbal Learning Test [RAVLT] Learning Over Trials; Wechsler Memory Scale 4th Edition [WMS-4] Logical Memory [LM] Story B immediate; and WMS-4 Visual Reproduction [VR] immediate)
- Memory (RAVLT delayed recall, WMS-4 LM delayed recall, and WMS-4 VR delayed recall)
- Language (Multilingual Naming Test, Auditory Naming Test, and animal fluency)
- Executive function/processing speed (Letter fluency and Trail-Making Test Parts A and B)
The study found a correlation between higher ADI (most disadvantaged) and poorer performance on learning (Spearman rho: -0.433; 95% CI -0.664 to -0.126; P = .006), memory (r = -0.496; 95% CI -0.707 to -0.205; P = .001), and executive function/processes speed (r = -0.315; 95% CI -0.577 to 0.006; P = .048), but no significant association with language.
Looking at individual-level data, the study found memory and processing speed “were driving the relationship, and again, patients had worse performance when they were coming from the most disadvantaged neighborhoods,” said Dr. Reyes.
The investigators also examined mood, including depression and anxiety, and subjective complaints of cognitive problems. “We found those patients residing in the most disadvantaged neighborhoods complained more about memory problems,” she said.
The results underscore the need for community-level interventions “that could provide resources in support of these older adults and their families and connect them to services we know are good for brain health,” said Dr. Reyes.
Alzheimer’s disease experts “have done a really good job of this, but this is new for epilepsy,” she added. “This gives us a great opportunity to kind of bridge the worlds of dementia and epilepsy.”
Novel Research
Commenting on the research, Rani Sarkis, MD, assistant professor of neurology, Brigham and Women’s Hospital, Boston, said the study is “very useful” as it ties social determinants of health to cognition.
“We have not been doing that” in people with epilepsy, he said.
The study, one of the first to look at the link between disadvantaged neighborhoods and cognitive impairment, “has very important” public health implications, including the need to consider access to activities that promote cognitive resilience and other brain health initiatives, said Dr. Sarkis.
Another larger study that looked at neighborhood deprivation and cognition in epilepsy was also presented at the AES meeting and published earlier this year in the journal Neurology.
That study included 800 patients with pharmaco-resistant temporal lobe epilepsy being evaluated for surgery at the Cleveland Clinic, mean age about 38 years. It examined numerous cognitive domains as well as depression and anxiety in relation to ADI generated by patient addresses and split into quintiles from least to most disadvantaged.
After controlling for covariants, the study found scores for all cognitive domains were significantly worse in the most disadvantaged quintile except for executive function, which was close to reaching significance (P = .052), said lead author Robyn M. Busch, PhD, a clinical neuropsychologist in the Epilepsy Center, Department of Neurology, Cleveland Clinic.
The study also found people in the most disadvantaged areas had more symptoms of depression and anxiety compared with people in the least disadvantaged areas, said Busch.
A Complex Issue
Although the exact mechanism tying disadvantaged areas to cognition in epilepsy isn’t fully understood, having less access to health care and educational opportunities, poor nutrition, and being under chronic stress “are all things that affect the brain,” said Dr. Busch.
“This is super complex and it’s going to be really difficult to tease apart, but we’d like to look at imaging data to see if it’s something structural, if there are functional changes in the brain or something that might help us understand this better.”
But it’s also possible that having epilepsy “might be pushing people into environments” that offer fewer employment and educational opportunities and less access to resources, she said.
The study authors and Dr. Sarkis report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ORLANDO — , early research suggests.
Seniors with epilepsy present with multiple comorbidities, including, for example, hypertension and diabetes, and they are at increased risk of developing dementia, said study investigator Anny Reyes, PhD, a postdoctoral scholar at the University of California at San Diego.
Past research has shown neighborhood disadvantage is associated with numerous adverse health outcomes, including an increased risk for developing Alzheimer’s disease and related dementias (ADRD).
“We already know epilepsy on its own increases risks for dementia, and when you add disadvantaged to that, it’s going to increase the risk even more,” said Dr. Reyes.
Neurologists should ask their older patients with epilepsy, many of whom live alone, about food insecurity and access to resources “not just within the hospital system but also within their community,” she said.
The findings were presented at the annual meeting of the American Epilepsy Society.
Proxy Measure of Disadvantage
The incidence and prevalence of epilepsy increases with age. Older adults represent the fastest growing segment of individuals with epilepsy, said Dr. Reyes.
The new study included 40 patients with focal epilepsy, average age 67 years, from three areas: San Diego, California; Madison, Wisconsin; and Cleveland, Ohio.
Researchers collected clinical and sociodemographic information as well as vascular biomarkers. They also gathered individual-level data, including income, parental education levels, details on childhood upbringing, etc.
Using residential addresses, investigators determined the area deprivation index (ADI) value for study participants. The ADI is a proxy measure for neighborhood-level socioeconomic disadvantage that captures factors such a poverty, employment, housing, and education opportunities.
ADI values range from 1 to 10, with a higher number indicating greater neighborhood disadvantage. About 30% of the cohort had an ADI decile greater than 6.
Researchers divided subjects into Most Disadvantaged (ADI greater than 7) and Least Disadvantaged (AD 7 or less). The two groups were similar with regard to age, education level, and race/ethnicity.
But those from the most disadvantaged areas were younger, taking more antiseizure medications, had fewer years of education, lower levels of father’s education, less personal and family income, and were less likely to be diagnosed with hypertension.
Study subjects completed neuropsychological testing, including:
- Measures of learning (Rey Auditory Verbal Learning Test [RAVLT] Learning Over Trials; Wechsler Memory Scale 4th Edition [WMS-4] Logical Memory [LM] Story B immediate; and WMS-4 Visual Reproduction [VR] immediate)
- Memory (RAVLT delayed recall, WMS-4 LM delayed recall, and WMS-4 VR delayed recall)
- Language (Multilingual Naming Test, Auditory Naming Test, and animal fluency)
- Executive function/processing speed (Letter fluency and Trail-Making Test Parts A and B)
The study found a correlation between higher ADI (most disadvantaged) and poorer performance on learning (Spearman rho: -0.433; 95% CI -0.664 to -0.126; P = .006), memory (r = -0.496; 95% CI -0.707 to -0.205; P = .001), and executive function/processes speed (r = -0.315; 95% CI -0.577 to 0.006; P = .048), but no significant association with language.
Looking at individual-level data, the study found memory and processing speed “were driving the relationship, and again, patients had worse performance when they were coming from the most disadvantaged neighborhoods,” said Dr. Reyes.
The investigators also examined mood, including depression and anxiety, and subjective complaints of cognitive problems. “We found those patients residing in the most disadvantaged neighborhoods complained more about memory problems,” she said.
The results underscore the need for community-level interventions “that could provide resources in support of these older adults and their families and connect them to services we know are good for brain health,” said Dr. Reyes.
Alzheimer’s disease experts “have done a really good job of this, but this is new for epilepsy,” she added. “This gives us a great opportunity to kind of bridge the worlds of dementia and epilepsy.”
Novel Research
Commenting on the research, Rani Sarkis, MD, assistant professor of neurology, Brigham and Women’s Hospital, Boston, said the study is “very useful” as it ties social determinants of health to cognition.
“We have not been doing that” in people with epilepsy, he said.
The study, one of the first to look at the link between disadvantaged neighborhoods and cognitive impairment, “has very important” public health implications, including the need to consider access to activities that promote cognitive resilience and other brain health initiatives, said Dr. Sarkis.
Another larger study that looked at neighborhood deprivation and cognition in epilepsy was also presented at the AES meeting and published earlier this year in the journal Neurology.
That study included 800 patients with pharmaco-resistant temporal lobe epilepsy being evaluated for surgery at the Cleveland Clinic, mean age about 38 years. It examined numerous cognitive domains as well as depression and anxiety in relation to ADI generated by patient addresses and split into quintiles from least to most disadvantaged.
After controlling for covariants, the study found scores for all cognitive domains were significantly worse in the most disadvantaged quintile except for executive function, which was close to reaching significance (P = .052), said lead author Robyn M. Busch, PhD, a clinical neuropsychologist in the Epilepsy Center, Department of Neurology, Cleveland Clinic.
The study also found people in the most disadvantaged areas had more symptoms of depression and anxiety compared with people in the least disadvantaged areas, said Busch.
A Complex Issue
Although the exact mechanism tying disadvantaged areas to cognition in epilepsy isn’t fully understood, having less access to health care and educational opportunities, poor nutrition, and being under chronic stress “are all things that affect the brain,” said Dr. Busch.
“This is super complex and it’s going to be really difficult to tease apart, but we’d like to look at imaging data to see if it’s something structural, if there are functional changes in the brain or something that might help us understand this better.”
But it’s also possible that having epilepsy “might be pushing people into environments” that offer fewer employment and educational opportunities and less access to resources, she said.
The study authors and Dr. Sarkis report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ORLANDO — , early research suggests.
Seniors with epilepsy present with multiple comorbidities, including, for example, hypertension and diabetes, and they are at increased risk of developing dementia, said study investigator Anny Reyes, PhD, a postdoctoral scholar at the University of California at San Diego.
Past research has shown neighborhood disadvantage is associated with numerous adverse health outcomes, including an increased risk for developing Alzheimer’s disease and related dementias (ADRD).
“We already know epilepsy on its own increases risks for dementia, and when you add disadvantaged to that, it’s going to increase the risk even more,” said Dr. Reyes.
Neurologists should ask their older patients with epilepsy, many of whom live alone, about food insecurity and access to resources “not just within the hospital system but also within their community,” she said.
The findings were presented at the annual meeting of the American Epilepsy Society.
Proxy Measure of Disadvantage
The incidence and prevalence of epilepsy increases with age. Older adults represent the fastest growing segment of individuals with epilepsy, said Dr. Reyes.
The new study included 40 patients with focal epilepsy, average age 67 years, from three areas: San Diego, California; Madison, Wisconsin; and Cleveland, Ohio.
Researchers collected clinical and sociodemographic information as well as vascular biomarkers. They also gathered individual-level data, including income, parental education levels, details on childhood upbringing, etc.
Using residential addresses, investigators determined the area deprivation index (ADI) value for study participants. The ADI is a proxy measure for neighborhood-level socioeconomic disadvantage that captures factors such a poverty, employment, housing, and education opportunities.
ADI values range from 1 to 10, with a higher number indicating greater neighborhood disadvantage. About 30% of the cohort had an ADI decile greater than 6.
Researchers divided subjects into Most Disadvantaged (ADI greater than 7) and Least Disadvantaged (AD 7 or less). The two groups were similar with regard to age, education level, and race/ethnicity.
But those from the most disadvantaged areas were younger, taking more antiseizure medications, had fewer years of education, lower levels of father’s education, less personal and family income, and were less likely to be diagnosed with hypertension.
Study subjects completed neuropsychological testing, including:
- Measures of learning (Rey Auditory Verbal Learning Test [RAVLT] Learning Over Trials; Wechsler Memory Scale 4th Edition [WMS-4] Logical Memory [LM] Story B immediate; and WMS-4 Visual Reproduction [VR] immediate)
- Memory (RAVLT delayed recall, WMS-4 LM delayed recall, and WMS-4 VR delayed recall)
- Language (Multilingual Naming Test, Auditory Naming Test, and animal fluency)
- Executive function/processing speed (Letter fluency and Trail-Making Test Parts A and B)
The study found a correlation between higher ADI (most disadvantaged) and poorer performance on learning (Spearman rho: -0.433; 95% CI -0.664 to -0.126; P = .006), memory (r = -0.496; 95% CI -0.707 to -0.205; P = .001), and executive function/processes speed (r = -0.315; 95% CI -0.577 to 0.006; P = .048), but no significant association with language.
Looking at individual-level data, the study found memory and processing speed “were driving the relationship, and again, patients had worse performance when they were coming from the most disadvantaged neighborhoods,” said Dr. Reyes.
The investigators also examined mood, including depression and anxiety, and subjective complaints of cognitive problems. “We found those patients residing in the most disadvantaged neighborhoods complained more about memory problems,” she said.
The results underscore the need for community-level interventions “that could provide resources in support of these older adults and their families and connect them to services we know are good for brain health,” said Dr. Reyes.
Alzheimer’s disease experts “have done a really good job of this, but this is new for epilepsy,” she added. “This gives us a great opportunity to kind of bridge the worlds of dementia and epilepsy.”
Novel Research
Commenting on the research, Rani Sarkis, MD, assistant professor of neurology, Brigham and Women’s Hospital, Boston, said the study is “very useful” as it ties social determinants of health to cognition.
“We have not been doing that” in people with epilepsy, he said.
The study, one of the first to look at the link between disadvantaged neighborhoods and cognitive impairment, “has very important” public health implications, including the need to consider access to activities that promote cognitive resilience and other brain health initiatives, said Dr. Sarkis.
Another larger study that looked at neighborhood deprivation and cognition in epilepsy was also presented at the AES meeting and published earlier this year in the journal Neurology.
That study included 800 patients with pharmaco-resistant temporal lobe epilepsy being evaluated for surgery at the Cleveland Clinic, mean age about 38 years. It examined numerous cognitive domains as well as depression and anxiety in relation to ADI generated by patient addresses and split into quintiles from least to most disadvantaged.
After controlling for covariants, the study found scores for all cognitive domains were significantly worse in the most disadvantaged quintile except for executive function, which was close to reaching significance (P = .052), said lead author Robyn M. Busch, PhD, a clinical neuropsychologist in the Epilepsy Center, Department of Neurology, Cleveland Clinic.
The study also found people in the most disadvantaged areas had more symptoms of depression and anxiety compared with people in the least disadvantaged areas, said Busch.
A Complex Issue
Although the exact mechanism tying disadvantaged areas to cognition in epilepsy isn’t fully understood, having less access to health care and educational opportunities, poor nutrition, and being under chronic stress “are all things that affect the brain,” said Dr. Busch.
“This is super complex and it’s going to be really difficult to tease apart, but we’d like to look at imaging data to see if it’s something structural, if there are functional changes in the brain or something that might help us understand this better.”
But it’s also possible that having epilepsy “might be pushing people into environments” that offer fewer employment and educational opportunities and less access to resources, she said.
The study authors and Dr. Sarkis report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AES 2023