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Medical student well-being during the COVID-19 pandemic
During the initial stage of the COVID-19 pandemic U.S. medical students were suspended from in-person clinical interaction. This decision was based on specific guidance from the Association of American Medical Colleges and subsequently implemented in medical schools across the United States.1 Our research project addressed students’ stress level before and after clinical in-person suspension and assessed medical students perceived COVID-19–related risk level. We were particularly curious to learn about students’ emotional struggles as they navigated the initial pedagogical uncertainty associated with the pandemic.
It is likely that heightened stress was greater than before and the rationale was likely multifactorial in nature.2
One key stressor U.S. medical students faced was the negative impacts of COVID-19 on medical education. U.S. Medical Licensing Examination exam-taking was severely impacted, and some students needed to reschedule their test dates because of increased restrictions at testing centers. Third-year medical students in particular were worried about how COVID-19 would influence their residency application; for example, in-person residency interviews and away rotations as fourth-year medical students. Another concern was not being able to be involved in clinical work during the direst stage of this public health emergency because of personal protective equipment shortages and attempts to reduce community spread of COVID-19.
Our study also showed that students had a relatively lower perceived risk level when it comes to COVID-19 than health care workers in the 2003 SARS epidemic, which we suspect is mostly attributable to the suspension of clinical in-person interaction. We also found that female gender and self-reported mental illness diagnosis were two risk factors for perceived stress level, consistent with our current literature.
The reality of clinical in-person inaction caused by PPE shortage and limited telehealth options, together with social isolation and uncertainty regarding future education opportunities, appear to have had a detrimental effect on medical students’ psychological wellbeing. This did not have to be the case. Some medical students found innovative ways to stay involved.
For example, in 2020 some of Dr. Zhang’s classmates helped proctor virtual group therapy sessions held by the local National Alliance on Mental Illness chapter. Medical students at the Icahn School of Medicine at Mount Sinai, New York were not only able to engage in telehealth but also join other task forces, such as PPE supply, distribution, and coordination, morale promotion, and administrative services.3 Finally, many medical students in New York volunteered in providing child care for frontline doctors to help relieve their burden.4 These actions, if implemented more widely, may have had a protective effect on the stress and well-being of medical students at that time.
While our study focused on the academic side of things, the personal impacts from COVID-19 need to be acknowledged – sickness from COVID-19 and its sequelae, family loss fromCOVID-19, financial struggle, and racial targeting of Asians to name a few. COVID-19 has influenced many families’ livelihood and changed our understanding of ourselves, others, and the world in unprecedented ways.
Fast forward to today – medical students are used to learning and living in a world with an ongoing pandemic, and medical education and residency application process have adapted to this new normal. The once-crippling uncertainty surrounding COVID-19 and disastrous PPE shortages have passed. Yet, COVID-19 continues to be a stressor. In fact, burnout related to “COVID-19 fatigue” has been on the rise and one recent national survey shows one in five physicians intends to leave practice within 2 years.5
Meanwhile, uncertainty continued to persist, as in August 2022 monkeypox was declared a public health emergency in the United States.6 What Dr. Zhang learned as a medical student during the initial months of COVID-19 continues to be relevant: connect with loved ones, understand the changing reality, process the emotions, recognize what is under one’s control, have a solution-oriented mindset, and be forgiving and patient with oneself and others.
Dr. Zhang is a second-year psychiatry resident physician at Saint Elizabeth’s Hospital/DC DBH, Washington. Dr. Himelhoch serves as professor and chair of the department of psychiatry at the University of Kentucky, Lexington. His research focuses on developing and studying the efficacy of innovative strategies aimed at improving the health and welfare among people with co-occurring psychiatric and substance use disorders.
References
1. Association of American Medical Colleges. Important Guidance for Medical Students on Clinical Rotations During the Coronavirus (COVID-19) Outbreak. 2020 Mar 17.
2. Zhang Y et al. Psychiatry Res. 2022;313:114595. doi: 10.1016/j.psychres.2022.114595.
3. Bahethi RR et al. Acad Med. 2021 Jun 1;96(6):859-63. doi: 10.1097/ACM.0000000000003863.
4. Krieger P and Goodnough A. Medical Students, Sidelined for Now, Find New Ways to Fight Coronavirus. The New York Times. 2020 Mar 23.
5. Abbasi J. JAMA. 2022 Apr 19;327(15):1435-7. doi: 10.1001/jama.2022.5074.
6. Department of Health & Human Services. Biden-Harris Administration Bolsters Monkeypox Response; HHS Secretary Becerra Declares Public Health Emergency. 2022 Aug 4.
During the initial stage of the COVID-19 pandemic U.S. medical students were suspended from in-person clinical interaction. This decision was based on specific guidance from the Association of American Medical Colleges and subsequently implemented in medical schools across the United States.1 Our research project addressed students’ stress level before and after clinical in-person suspension and assessed medical students perceived COVID-19–related risk level. We were particularly curious to learn about students’ emotional struggles as they navigated the initial pedagogical uncertainty associated with the pandemic.
It is likely that heightened stress was greater than before and the rationale was likely multifactorial in nature.2
One key stressor U.S. medical students faced was the negative impacts of COVID-19 on medical education. U.S. Medical Licensing Examination exam-taking was severely impacted, and some students needed to reschedule their test dates because of increased restrictions at testing centers. Third-year medical students in particular were worried about how COVID-19 would influence their residency application; for example, in-person residency interviews and away rotations as fourth-year medical students. Another concern was not being able to be involved in clinical work during the direst stage of this public health emergency because of personal protective equipment shortages and attempts to reduce community spread of COVID-19.
Our study also showed that students had a relatively lower perceived risk level when it comes to COVID-19 than health care workers in the 2003 SARS epidemic, which we suspect is mostly attributable to the suspension of clinical in-person interaction. We also found that female gender and self-reported mental illness diagnosis were two risk factors for perceived stress level, consistent with our current literature.
The reality of clinical in-person inaction caused by PPE shortage and limited telehealth options, together with social isolation and uncertainty regarding future education opportunities, appear to have had a detrimental effect on medical students’ psychological wellbeing. This did not have to be the case. Some medical students found innovative ways to stay involved.
For example, in 2020 some of Dr. Zhang’s classmates helped proctor virtual group therapy sessions held by the local National Alliance on Mental Illness chapter. Medical students at the Icahn School of Medicine at Mount Sinai, New York were not only able to engage in telehealth but also join other task forces, such as PPE supply, distribution, and coordination, morale promotion, and administrative services.3 Finally, many medical students in New York volunteered in providing child care for frontline doctors to help relieve their burden.4 These actions, if implemented more widely, may have had a protective effect on the stress and well-being of medical students at that time.
While our study focused on the academic side of things, the personal impacts from COVID-19 need to be acknowledged – sickness from COVID-19 and its sequelae, family loss fromCOVID-19, financial struggle, and racial targeting of Asians to name a few. COVID-19 has influenced many families’ livelihood and changed our understanding of ourselves, others, and the world in unprecedented ways.
Fast forward to today – medical students are used to learning and living in a world with an ongoing pandemic, and medical education and residency application process have adapted to this new normal. The once-crippling uncertainty surrounding COVID-19 and disastrous PPE shortages have passed. Yet, COVID-19 continues to be a stressor. In fact, burnout related to “COVID-19 fatigue” has been on the rise and one recent national survey shows one in five physicians intends to leave practice within 2 years.5
Meanwhile, uncertainty continued to persist, as in August 2022 monkeypox was declared a public health emergency in the United States.6 What Dr. Zhang learned as a medical student during the initial months of COVID-19 continues to be relevant: connect with loved ones, understand the changing reality, process the emotions, recognize what is under one’s control, have a solution-oriented mindset, and be forgiving and patient with oneself and others.
Dr. Zhang is a second-year psychiatry resident physician at Saint Elizabeth’s Hospital/DC DBH, Washington. Dr. Himelhoch serves as professor and chair of the department of psychiatry at the University of Kentucky, Lexington. His research focuses on developing and studying the efficacy of innovative strategies aimed at improving the health and welfare among people with co-occurring psychiatric and substance use disorders.
References
1. Association of American Medical Colleges. Important Guidance for Medical Students on Clinical Rotations During the Coronavirus (COVID-19) Outbreak. 2020 Mar 17.
2. Zhang Y et al. Psychiatry Res. 2022;313:114595. doi: 10.1016/j.psychres.2022.114595.
3. Bahethi RR et al. Acad Med. 2021 Jun 1;96(6):859-63. doi: 10.1097/ACM.0000000000003863.
4. Krieger P and Goodnough A. Medical Students, Sidelined for Now, Find New Ways to Fight Coronavirus. The New York Times. 2020 Mar 23.
5. Abbasi J. JAMA. 2022 Apr 19;327(15):1435-7. doi: 10.1001/jama.2022.5074.
6. Department of Health & Human Services. Biden-Harris Administration Bolsters Monkeypox Response; HHS Secretary Becerra Declares Public Health Emergency. 2022 Aug 4.
During the initial stage of the COVID-19 pandemic U.S. medical students were suspended from in-person clinical interaction. This decision was based on specific guidance from the Association of American Medical Colleges and subsequently implemented in medical schools across the United States.1 Our research project addressed students’ stress level before and after clinical in-person suspension and assessed medical students perceived COVID-19–related risk level. We were particularly curious to learn about students’ emotional struggles as they navigated the initial pedagogical uncertainty associated with the pandemic.
It is likely that heightened stress was greater than before and the rationale was likely multifactorial in nature.2
One key stressor U.S. medical students faced was the negative impacts of COVID-19 on medical education. U.S. Medical Licensing Examination exam-taking was severely impacted, and some students needed to reschedule their test dates because of increased restrictions at testing centers. Third-year medical students in particular were worried about how COVID-19 would influence their residency application; for example, in-person residency interviews and away rotations as fourth-year medical students. Another concern was not being able to be involved in clinical work during the direst stage of this public health emergency because of personal protective equipment shortages and attempts to reduce community spread of COVID-19.
Our study also showed that students had a relatively lower perceived risk level when it comes to COVID-19 than health care workers in the 2003 SARS epidemic, which we suspect is mostly attributable to the suspension of clinical in-person interaction. We also found that female gender and self-reported mental illness diagnosis were two risk factors for perceived stress level, consistent with our current literature.
The reality of clinical in-person inaction caused by PPE shortage and limited telehealth options, together with social isolation and uncertainty regarding future education opportunities, appear to have had a detrimental effect on medical students’ psychological wellbeing. This did not have to be the case. Some medical students found innovative ways to stay involved.
For example, in 2020 some of Dr. Zhang’s classmates helped proctor virtual group therapy sessions held by the local National Alliance on Mental Illness chapter. Medical students at the Icahn School of Medicine at Mount Sinai, New York were not only able to engage in telehealth but also join other task forces, such as PPE supply, distribution, and coordination, morale promotion, and administrative services.3 Finally, many medical students in New York volunteered in providing child care for frontline doctors to help relieve their burden.4 These actions, if implemented more widely, may have had a protective effect on the stress and well-being of medical students at that time.
While our study focused on the academic side of things, the personal impacts from COVID-19 need to be acknowledged – sickness from COVID-19 and its sequelae, family loss fromCOVID-19, financial struggle, and racial targeting of Asians to name a few. COVID-19 has influenced many families’ livelihood and changed our understanding of ourselves, others, and the world in unprecedented ways.
Fast forward to today – medical students are used to learning and living in a world with an ongoing pandemic, and medical education and residency application process have adapted to this new normal. The once-crippling uncertainty surrounding COVID-19 and disastrous PPE shortages have passed. Yet, COVID-19 continues to be a stressor. In fact, burnout related to “COVID-19 fatigue” has been on the rise and one recent national survey shows one in five physicians intends to leave practice within 2 years.5
Meanwhile, uncertainty continued to persist, as in August 2022 monkeypox was declared a public health emergency in the United States.6 What Dr. Zhang learned as a medical student during the initial months of COVID-19 continues to be relevant: connect with loved ones, understand the changing reality, process the emotions, recognize what is under one’s control, have a solution-oriented mindset, and be forgiving and patient with oneself and others.
Dr. Zhang is a second-year psychiatry resident physician at Saint Elizabeth’s Hospital/DC DBH, Washington. Dr. Himelhoch serves as professor and chair of the department of psychiatry at the University of Kentucky, Lexington. His research focuses on developing and studying the efficacy of innovative strategies aimed at improving the health and welfare among people with co-occurring psychiatric and substance use disorders.
References
1. Association of American Medical Colleges. Important Guidance for Medical Students on Clinical Rotations During the Coronavirus (COVID-19) Outbreak. 2020 Mar 17.
2. Zhang Y et al. Psychiatry Res. 2022;313:114595. doi: 10.1016/j.psychres.2022.114595.
3. Bahethi RR et al. Acad Med. 2021 Jun 1;96(6):859-63. doi: 10.1097/ACM.0000000000003863.
4. Krieger P and Goodnough A. Medical Students, Sidelined for Now, Find New Ways to Fight Coronavirus. The New York Times. 2020 Mar 23.
5. Abbasi J. JAMA. 2022 Apr 19;327(15):1435-7. doi: 10.1001/jama.2022.5074.
6. Department of Health & Human Services. Biden-Harris Administration Bolsters Monkeypox Response; HHS Secretary Becerra Declares Public Health Emergency. 2022 Aug 4.
Obesity impacts peripheral airway reactivity, asthma
Peripheral airway response to methacholine was similar among obese adults with and without asthma, although forced expiratory volume was lower for those with asthma, based on data from 53 individuals.
Obesity remains a risk factor for asthma, and obese individuals with asthma tend to have worse control and more severe disease, compared with nonobese asthma patients, wrote Anne E. Dixon, BM, BCh, of the University of Vermont, Burlington, and colleagues.
Previous studies have shown that airway reactivity can occur in obese individuals without airway inflammation, but studies characterizing obese asthma based on lung function are lacking, they said. “Combining spirometry and oscillometry might reveal abnormalities in lung mechanics particularly pertinent to people with obesity and asthma,” the researchers noted.
In a cross-sectional study published in the journal CHEST, the researchers reviewed data from 31 obese adults with asthma and 22 obese adults without asthma. The participants were aged 18 years and older, with forced expiratory volume (FEV1) of at least 60% of predicted. All had class III obesity, with an average BMI of 47.2 kg/m2 for those with asthma and 46.7 kg/m2 for nonasthma controls. Demographic characteristics were similar between the groups.
Airway reactivity was defined as a 20% decrease in FEV1 and/or a 50% change in resistance or reactance at 5 Hz (R5 and X5), at a concentration of 16 mg/mL or less of methacholine. Patients were assessed using spirometry and oscillometry.
For those with asthma, the resistance at 5 Hz, measured by oscillometry, increased by 52% in response to the PC20 methacholine challenge, with an area under the reactance curve (AX) of 361%. For controls without asthma, the resistance at 5 Hz increased by 45%, with an AX of 268% in response to 16 mg/mL of methacholine.
This finding suggests that obesity predisposes individuals to peripheral airway reactivity regardless of asthma status, the researchers wrote in their discussion.
The researchers also identified two distinct groups of asthma patients categorized by respiratory system impedance based on more concordant vs. discordant bronchoconstriction in the central and peripheral airways. The baseline AX for these two groups was 11.8 and 46.7, respectively, with interquartile ranges of 9.9-23.4 and 23.2-53.7, respectively.
The discordant group included only women, and these patients reported significantly more gastroesophageal reflux, increased chest tightness, and more wheezing and asthma exacerbations than the concordant group, which may be related to air trapping, shown on previous studies of obese individuals with asthma, the researchers wrote.
The findings were limited by several factors, including the measurement of airway impedance only at the peak methacholine dose and the measurement of oscillometry after spirometry, the researchers noted. Other limitations included the relatively small study population at a single center, and the focus on obese individuals only.
More research is needed in larger and more diverse patient populations, but the results support the characterization of a subgroup of obese asthma patients with significant peripheral airway dysfunction, the researchers wrote.
“Oscillometry testing can reveal a physiologic phenotype of asthma in obesity that may be related to worse symptoms and more severe disease, and also reveal subclinical abnormalities in people with obesity, but without clinically diagnosed lung disease,” they concluded.
The study was supported in part by the National Institutes of Health. The researchers declared no financial conflicts.
A version of this article first appeared on Medscape.com.
Peripheral airway response to methacholine was similar among obese adults with and without asthma, although forced expiratory volume was lower for those with asthma, based on data from 53 individuals.
Obesity remains a risk factor for asthma, and obese individuals with asthma tend to have worse control and more severe disease, compared with nonobese asthma patients, wrote Anne E. Dixon, BM, BCh, of the University of Vermont, Burlington, and colleagues.
Previous studies have shown that airway reactivity can occur in obese individuals without airway inflammation, but studies characterizing obese asthma based on lung function are lacking, they said. “Combining spirometry and oscillometry might reveal abnormalities in lung mechanics particularly pertinent to people with obesity and asthma,” the researchers noted.
In a cross-sectional study published in the journal CHEST, the researchers reviewed data from 31 obese adults with asthma and 22 obese adults without asthma. The participants were aged 18 years and older, with forced expiratory volume (FEV1) of at least 60% of predicted. All had class III obesity, with an average BMI of 47.2 kg/m2 for those with asthma and 46.7 kg/m2 for nonasthma controls. Demographic characteristics were similar between the groups.
Airway reactivity was defined as a 20% decrease in FEV1 and/or a 50% change in resistance or reactance at 5 Hz (R5 and X5), at a concentration of 16 mg/mL or less of methacholine. Patients were assessed using spirometry and oscillometry.
For those with asthma, the resistance at 5 Hz, measured by oscillometry, increased by 52% in response to the PC20 methacholine challenge, with an area under the reactance curve (AX) of 361%. For controls without asthma, the resistance at 5 Hz increased by 45%, with an AX of 268% in response to 16 mg/mL of methacholine.
This finding suggests that obesity predisposes individuals to peripheral airway reactivity regardless of asthma status, the researchers wrote in their discussion.
The researchers also identified two distinct groups of asthma patients categorized by respiratory system impedance based on more concordant vs. discordant bronchoconstriction in the central and peripheral airways. The baseline AX for these two groups was 11.8 and 46.7, respectively, with interquartile ranges of 9.9-23.4 and 23.2-53.7, respectively.
The discordant group included only women, and these patients reported significantly more gastroesophageal reflux, increased chest tightness, and more wheezing and asthma exacerbations than the concordant group, which may be related to air trapping, shown on previous studies of obese individuals with asthma, the researchers wrote.
The findings were limited by several factors, including the measurement of airway impedance only at the peak methacholine dose and the measurement of oscillometry after spirometry, the researchers noted. Other limitations included the relatively small study population at a single center, and the focus on obese individuals only.
More research is needed in larger and more diverse patient populations, but the results support the characterization of a subgroup of obese asthma patients with significant peripheral airway dysfunction, the researchers wrote.
“Oscillometry testing can reveal a physiologic phenotype of asthma in obesity that may be related to worse symptoms and more severe disease, and also reveal subclinical abnormalities in people with obesity, but without clinically diagnosed lung disease,” they concluded.
The study was supported in part by the National Institutes of Health. The researchers declared no financial conflicts.
A version of this article first appeared on Medscape.com.
Peripheral airway response to methacholine was similar among obese adults with and without asthma, although forced expiratory volume was lower for those with asthma, based on data from 53 individuals.
Obesity remains a risk factor for asthma, and obese individuals with asthma tend to have worse control and more severe disease, compared with nonobese asthma patients, wrote Anne E. Dixon, BM, BCh, of the University of Vermont, Burlington, and colleagues.
Previous studies have shown that airway reactivity can occur in obese individuals without airway inflammation, but studies characterizing obese asthma based on lung function are lacking, they said. “Combining spirometry and oscillometry might reveal abnormalities in lung mechanics particularly pertinent to people with obesity and asthma,” the researchers noted.
In a cross-sectional study published in the journal CHEST, the researchers reviewed data from 31 obese adults with asthma and 22 obese adults without asthma. The participants were aged 18 years and older, with forced expiratory volume (FEV1) of at least 60% of predicted. All had class III obesity, with an average BMI of 47.2 kg/m2 for those with asthma and 46.7 kg/m2 for nonasthma controls. Demographic characteristics were similar between the groups.
Airway reactivity was defined as a 20% decrease in FEV1 and/or a 50% change in resistance or reactance at 5 Hz (R5 and X5), at a concentration of 16 mg/mL or less of methacholine. Patients were assessed using spirometry and oscillometry.
For those with asthma, the resistance at 5 Hz, measured by oscillometry, increased by 52% in response to the PC20 methacholine challenge, with an area under the reactance curve (AX) of 361%. For controls without asthma, the resistance at 5 Hz increased by 45%, with an AX of 268% in response to 16 mg/mL of methacholine.
This finding suggests that obesity predisposes individuals to peripheral airway reactivity regardless of asthma status, the researchers wrote in their discussion.
The researchers also identified two distinct groups of asthma patients categorized by respiratory system impedance based on more concordant vs. discordant bronchoconstriction in the central and peripheral airways. The baseline AX for these two groups was 11.8 and 46.7, respectively, with interquartile ranges of 9.9-23.4 and 23.2-53.7, respectively.
The discordant group included only women, and these patients reported significantly more gastroesophageal reflux, increased chest tightness, and more wheezing and asthma exacerbations than the concordant group, which may be related to air trapping, shown on previous studies of obese individuals with asthma, the researchers wrote.
The findings were limited by several factors, including the measurement of airway impedance only at the peak methacholine dose and the measurement of oscillometry after spirometry, the researchers noted. Other limitations included the relatively small study population at a single center, and the focus on obese individuals only.
More research is needed in larger and more diverse patient populations, but the results support the characterization of a subgroup of obese asthma patients with significant peripheral airway dysfunction, the researchers wrote.
“Oscillometry testing can reveal a physiologic phenotype of asthma in obesity that may be related to worse symptoms and more severe disease, and also reveal subclinical abnormalities in people with obesity, but without clinically diagnosed lung disease,” they concluded.
The study was supported in part by the National Institutes of Health. The researchers declared no financial conflicts.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL CHEST
New guidelines on peds obesity call for aggressive treatment
and hope the problem solves itself. That’s the upshot of new guidelines from the American Academy of Pediatrics.
The authors of the guidelines also encourage primary care doctors to collaborate with other medical professionals to treat the comorbidities often linked to obesity, rather than take on the entire challenge themselves.
“It’s impossible to treat obesity within the four walls of the clinic. That’s one thing I have learned,” Ihuoma Eneli, MD, associate director of the AAP Institute for Healthy Childhood Weight, told this news organization. For example, a primary care doctor could partner with a gastroenterologist when treating a child who has nonalcoholic fatty liver disease, added Dr. Eneli, a professor of pediatrics at the Ohio State University, Columbus, who helped write the recommendations.
The new document updates 2007 recommendations from AAP about treating children and adolescents who are overweight or obese. The earlier statement focused on behavioral modification and healthy eating behaviors and paid less attention to weight-lowering medications or bariatric surgery for young people. That document did not offer specific advice to health care providers about how to address childhood overweight or obesity.
The 2023 guidelines recommend that pediatricians offer anyone aged 12 years and older with obesity – defined as a body mass index (BMI) at the 95th percentile or higher – the option of receiving weight-loss medications in addition to ongoing support for lifestyle modifications, such as exercising more and eating healthier foods.
The same approach holds for bariatric surgery once children reach age 13, and AAP stressed that no physician should ever stigmatize children or imply that they are to blame for their weight.
AAP did not receive any industry funding to develop the guidelines.
As children reach the threshold BMI levels, physicians should conduct complete physicals and order blood tests to get a fuller picture of the patients’ health.
These are the first guidelines from AAP aimed at giving pediatricians and other primary care providers concrete guidance for managing overweight and obesity in younger patients.
“Obesity is a complex, chronic disease, and that’s a frame shift here,” said Sandra S. Hassink, MD, leader of the guideline group and director of the AAP Institute for Healthy Childhood Weight.
Dr. Hassink compared obesity to asthma, another chronic disease that merits prompt attention and ongoing treatment. A physician would never let a child with asthma go untreated until their breathing problems are so severe that they turn blue, Dr. Hassink said; similarly, physicians should treat obesity in young people promptly and over time.
While some aspects of treating overweight and obesity are the same for children and adults, Dr. Hassink noted distinct differences. “Every child is embedded in a family and extended support structure,” Dr. Hassink said, which means that any obesity management technique needs the buy-in and support of the child’s family too.
AAP’s new advice reflects current understanding that excess weight or obesity in children is a result of biological and social factors, such as living in a food desert or experiencing the effects of structural racism.
The guidelines synthesize the results of hundreds of studies about the best way to treat excess weight in young people. If multiple studies were of high quality and all reached similar conclusions, they received an “A.” Less robust but still informative studies rated a “B.” In aggregate, the guideline about weight-lowering medication is based on “B” evidence that could shift with further research.
The authors recommend that clinicians calculate a child’s BMI beginning at age 2 years, with particular attention to those at the 85th percentile or higher for their age and sex (which would be defined as overweight), at the 95th percentile or higher (obesity), or at the 120th percentile and higher (severe obesity). Clinicians also should monitor blood pressure and cholesterol in their patients with overweight or obesity, particularly once they reach age 10.
Starting at age 6, providers should interview patients and their families about what would motivate them to lose weight, then tailor interventions to those factors rather than just make a blanket declaration that weight loss is necessary. This step should be coupled with intensive support – ideally, at least 26 hours of face-to-face support over the course of a year, although more is better – about effective exercise and dietary habits that result in weight loss.
The intensive support model should remain in place throughout childhood and adolescence and should be coupled with referrals for weight-loss medications or bariatric surgeries as needed once children reach age 12 or 13. Those age cutoffs are based on current evidence as to when weight-loss medications or surgery becomes effective, Dr. Hassink said, and could be shifted to lower ages if that’s what new evidence shows.
“Intensive health behavioral and lifestyle treatment is the base of all other treatment extensions,” Dr. Eneli said.
Young patients who needed weight-lowering medication used to have fewer options, according to Aaron S. Kelly, PhD, the Minnesota American Legion and Auxiliary Chair in Children’s Health at the University of Minnesota, Minneapolis.
.No longer.
Dr. Kelly was not involved in drafting the guidelines but was the lead investigator for trials of liraglutide (Saxenda), which in 2020 received U.S. Food and Drug Administration approval for treating obesity in adolescents. In 2022, the agency approved phentermine and topiramate extended-release capsules (Qsymia) for long-term weight management for patients aged 12 years and older, along with a once-weekly injection of semaglutide (Wegovy) patients in this age group. There are no weight-lowering medications for children younger than 12, Dr. Kelly said.
“Obesity is not a lifestyle problem. A lot of it is driven by the underlying biology,” Dr. Kelly said. “Really, what these medicines do is make it easier for people to make the right lifestyle choices by pushing back against the biology.”
For example, a drug can make people feel full for longer or disrupt chemical pathways that result in craving certain foods. Dr. Kelly emphasized that these drugs do not give license for people to eat as much as they want.
As for bariatric surgery, the new guidelines adhere closely to those in a 2019 AAP statement that bariatric surgery is safe and effective in pediatric settings. This is gratifying to Kirk W. Reichard, MD, MBA, a lead author of the 2019 article and director of the bariatric surgery program at Nemours Children’s Health.
Even if the information isn’t new as of 2023, Dr. Reichard said, AAP’s imprimatur could cause some eligible families to consider bariatric surgery when they may not have done so before.
Dr. Eneli, Dr. Hassink, and Dr. Reichard reported no relevant financial conflicts of interest. Dr. Kelly has relationships with Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus.
A version of this article first appeared on Medscape.com.
and hope the problem solves itself. That’s the upshot of new guidelines from the American Academy of Pediatrics.
The authors of the guidelines also encourage primary care doctors to collaborate with other medical professionals to treat the comorbidities often linked to obesity, rather than take on the entire challenge themselves.
“It’s impossible to treat obesity within the four walls of the clinic. That’s one thing I have learned,” Ihuoma Eneli, MD, associate director of the AAP Institute for Healthy Childhood Weight, told this news organization. For example, a primary care doctor could partner with a gastroenterologist when treating a child who has nonalcoholic fatty liver disease, added Dr. Eneli, a professor of pediatrics at the Ohio State University, Columbus, who helped write the recommendations.
The new document updates 2007 recommendations from AAP about treating children and adolescents who are overweight or obese. The earlier statement focused on behavioral modification and healthy eating behaviors and paid less attention to weight-lowering medications or bariatric surgery for young people. That document did not offer specific advice to health care providers about how to address childhood overweight or obesity.
The 2023 guidelines recommend that pediatricians offer anyone aged 12 years and older with obesity – defined as a body mass index (BMI) at the 95th percentile or higher – the option of receiving weight-loss medications in addition to ongoing support for lifestyle modifications, such as exercising more and eating healthier foods.
The same approach holds for bariatric surgery once children reach age 13, and AAP stressed that no physician should ever stigmatize children or imply that they are to blame for their weight.
AAP did not receive any industry funding to develop the guidelines.
As children reach the threshold BMI levels, physicians should conduct complete physicals and order blood tests to get a fuller picture of the patients’ health.
These are the first guidelines from AAP aimed at giving pediatricians and other primary care providers concrete guidance for managing overweight and obesity in younger patients.
“Obesity is a complex, chronic disease, and that’s a frame shift here,” said Sandra S. Hassink, MD, leader of the guideline group and director of the AAP Institute for Healthy Childhood Weight.
Dr. Hassink compared obesity to asthma, another chronic disease that merits prompt attention and ongoing treatment. A physician would never let a child with asthma go untreated until their breathing problems are so severe that they turn blue, Dr. Hassink said; similarly, physicians should treat obesity in young people promptly and over time.
While some aspects of treating overweight and obesity are the same for children and adults, Dr. Hassink noted distinct differences. “Every child is embedded in a family and extended support structure,” Dr. Hassink said, which means that any obesity management technique needs the buy-in and support of the child’s family too.
AAP’s new advice reflects current understanding that excess weight or obesity in children is a result of biological and social factors, such as living in a food desert or experiencing the effects of structural racism.
The guidelines synthesize the results of hundreds of studies about the best way to treat excess weight in young people. If multiple studies were of high quality and all reached similar conclusions, they received an “A.” Less robust but still informative studies rated a “B.” In aggregate, the guideline about weight-lowering medication is based on “B” evidence that could shift with further research.
The authors recommend that clinicians calculate a child’s BMI beginning at age 2 years, with particular attention to those at the 85th percentile or higher for their age and sex (which would be defined as overweight), at the 95th percentile or higher (obesity), or at the 120th percentile and higher (severe obesity). Clinicians also should monitor blood pressure and cholesterol in their patients with overweight or obesity, particularly once they reach age 10.
Starting at age 6, providers should interview patients and their families about what would motivate them to lose weight, then tailor interventions to those factors rather than just make a blanket declaration that weight loss is necessary. This step should be coupled with intensive support – ideally, at least 26 hours of face-to-face support over the course of a year, although more is better – about effective exercise and dietary habits that result in weight loss.
The intensive support model should remain in place throughout childhood and adolescence and should be coupled with referrals for weight-loss medications or bariatric surgeries as needed once children reach age 12 or 13. Those age cutoffs are based on current evidence as to when weight-loss medications or surgery becomes effective, Dr. Hassink said, and could be shifted to lower ages if that’s what new evidence shows.
“Intensive health behavioral and lifestyle treatment is the base of all other treatment extensions,” Dr. Eneli said.
Young patients who needed weight-lowering medication used to have fewer options, according to Aaron S. Kelly, PhD, the Minnesota American Legion and Auxiliary Chair in Children’s Health at the University of Minnesota, Minneapolis.
.No longer.
Dr. Kelly was not involved in drafting the guidelines but was the lead investigator for trials of liraglutide (Saxenda), which in 2020 received U.S. Food and Drug Administration approval for treating obesity in adolescents. In 2022, the agency approved phentermine and topiramate extended-release capsules (Qsymia) for long-term weight management for patients aged 12 years and older, along with a once-weekly injection of semaglutide (Wegovy) patients in this age group. There are no weight-lowering medications for children younger than 12, Dr. Kelly said.
“Obesity is not a lifestyle problem. A lot of it is driven by the underlying biology,” Dr. Kelly said. “Really, what these medicines do is make it easier for people to make the right lifestyle choices by pushing back against the biology.”
For example, a drug can make people feel full for longer or disrupt chemical pathways that result in craving certain foods. Dr. Kelly emphasized that these drugs do not give license for people to eat as much as they want.
As for bariatric surgery, the new guidelines adhere closely to those in a 2019 AAP statement that bariatric surgery is safe and effective in pediatric settings. This is gratifying to Kirk W. Reichard, MD, MBA, a lead author of the 2019 article and director of the bariatric surgery program at Nemours Children’s Health.
Even if the information isn’t new as of 2023, Dr. Reichard said, AAP’s imprimatur could cause some eligible families to consider bariatric surgery when they may not have done so before.
Dr. Eneli, Dr. Hassink, and Dr. Reichard reported no relevant financial conflicts of interest. Dr. Kelly has relationships with Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus.
A version of this article first appeared on Medscape.com.
and hope the problem solves itself. That’s the upshot of new guidelines from the American Academy of Pediatrics.
The authors of the guidelines also encourage primary care doctors to collaborate with other medical professionals to treat the comorbidities often linked to obesity, rather than take on the entire challenge themselves.
“It’s impossible to treat obesity within the four walls of the clinic. That’s one thing I have learned,” Ihuoma Eneli, MD, associate director of the AAP Institute for Healthy Childhood Weight, told this news organization. For example, a primary care doctor could partner with a gastroenterologist when treating a child who has nonalcoholic fatty liver disease, added Dr. Eneli, a professor of pediatrics at the Ohio State University, Columbus, who helped write the recommendations.
The new document updates 2007 recommendations from AAP about treating children and adolescents who are overweight or obese. The earlier statement focused on behavioral modification and healthy eating behaviors and paid less attention to weight-lowering medications or bariatric surgery for young people. That document did not offer specific advice to health care providers about how to address childhood overweight or obesity.
The 2023 guidelines recommend that pediatricians offer anyone aged 12 years and older with obesity – defined as a body mass index (BMI) at the 95th percentile or higher – the option of receiving weight-loss medications in addition to ongoing support for lifestyle modifications, such as exercising more and eating healthier foods.
The same approach holds for bariatric surgery once children reach age 13, and AAP stressed that no physician should ever stigmatize children or imply that they are to blame for their weight.
AAP did not receive any industry funding to develop the guidelines.
As children reach the threshold BMI levels, physicians should conduct complete physicals and order blood tests to get a fuller picture of the patients’ health.
These are the first guidelines from AAP aimed at giving pediatricians and other primary care providers concrete guidance for managing overweight and obesity in younger patients.
“Obesity is a complex, chronic disease, and that’s a frame shift here,” said Sandra S. Hassink, MD, leader of the guideline group and director of the AAP Institute for Healthy Childhood Weight.
Dr. Hassink compared obesity to asthma, another chronic disease that merits prompt attention and ongoing treatment. A physician would never let a child with asthma go untreated until their breathing problems are so severe that they turn blue, Dr. Hassink said; similarly, physicians should treat obesity in young people promptly and over time.
While some aspects of treating overweight and obesity are the same for children and adults, Dr. Hassink noted distinct differences. “Every child is embedded in a family and extended support structure,” Dr. Hassink said, which means that any obesity management technique needs the buy-in and support of the child’s family too.
AAP’s new advice reflects current understanding that excess weight or obesity in children is a result of biological and social factors, such as living in a food desert or experiencing the effects of structural racism.
The guidelines synthesize the results of hundreds of studies about the best way to treat excess weight in young people. If multiple studies were of high quality and all reached similar conclusions, they received an “A.” Less robust but still informative studies rated a “B.” In aggregate, the guideline about weight-lowering medication is based on “B” evidence that could shift with further research.
The authors recommend that clinicians calculate a child’s BMI beginning at age 2 years, with particular attention to those at the 85th percentile or higher for their age and sex (which would be defined as overweight), at the 95th percentile or higher (obesity), or at the 120th percentile and higher (severe obesity). Clinicians also should monitor blood pressure and cholesterol in their patients with overweight or obesity, particularly once they reach age 10.
Starting at age 6, providers should interview patients and their families about what would motivate them to lose weight, then tailor interventions to those factors rather than just make a blanket declaration that weight loss is necessary. This step should be coupled with intensive support – ideally, at least 26 hours of face-to-face support over the course of a year, although more is better – about effective exercise and dietary habits that result in weight loss.
The intensive support model should remain in place throughout childhood and adolescence and should be coupled with referrals for weight-loss medications or bariatric surgeries as needed once children reach age 12 or 13. Those age cutoffs are based on current evidence as to when weight-loss medications or surgery becomes effective, Dr. Hassink said, and could be shifted to lower ages if that’s what new evidence shows.
“Intensive health behavioral and lifestyle treatment is the base of all other treatment extensions,” Dr. Eneli said.
Young patients who needed weight-lowering medication used to have fewer options, according to Aaron S. Kelly, PhD, the Minnesota American Legion and Auxiliary Chair in Children’s Health at the University of Minnesota, Minneapolis.
.No longer.
Dr. Kelly was not involved in drafting the guidelines but was the lead investigator for trials of liraglutide (Saxenda), which in 2020 received U.S. Food and Drug Administration approval for treating obesity in adolescents. In 2022, the agency approved phentermine and topiramate extended-release capsules (Qsymia) for long-term weight management for patients aged 12 years and older, along with a once-weekly injection of semaglutide (Wegovy) patients in this age group. There are no weight-lowering medications for children younger than 12, Dr. Kelly said.
“Obesity is not a lifestyle problem. A lot of it is driven by the underlying biology,” Dr. Kelly said. “Really, what these medicines do is make it easier for people to make the right lifestyle choices by pushing back against the biology.”
For example, a drug can make people feel full for longer or disrupt chemical pathways that result in craving certain foods. Dr. Kelly emphasized that these drugs do not give license for people to eat as much as they want.
As for bariatric surgery, the new guidelines adhere closely to those in a 2019 AAP statement that bariatric surgery is safe and effective in pediatric settings. This is gratifying to Kirk W. Reichard, MD, MBA, a lead author of the 2019 article and director of the bariatric surgery program at Nemours Children’s Health.
Even if the information isn’t new as of 2023, Dr. Reichard said, AAP’s imprimatur could cause some eligible families to consider bariatric surgery when they may not have done so before.
Dr. Eneli, Dr. Hassink, and Dr. Reichard reported no relevant financial conflicts of interest. Dr. Kelly has relationships with Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus.
A version of this article first appeared on Medscape.com.
FROM PEDIATRICS
Little-used fitness measure could be key to exercise results
A new study out of Brigham Young University, Provo, Utah, suggests doctors could take that initiative to the next level, prescribing exercise plans that result in a specific health outcome; say, lowering your blood pressure or losing weight.
“The findings of this study, and others, suggest that we should be able to more consistently and accurately prescribe exercise like medicine,” says senior study author Jayson Gifford, PhD, an exercise sciences professor at BYU.
These exercise prescriptions would be tailored to patients based on a largely ignored fitness measure called critical power, or maximum steady state – the fastest you can go while maintaining a pace you can sustain for a long time.
By crafting workouts around critical power instead of the more frequently used VO2 max (maximum effort), we could more accurately predict health outcomes, just as we can with medicine, the researchers wrote in the Journal of Applied Physiology.
“We’ve known for centuries that exercise is part of the way to develop a healthy and long life,” says Jordan Metzl, MD, a sports medicine doctor at the Hospital for Special Surgery in New York and author of The Exercise Cure. “But it’s only in the past 70 years that we’ve recognized the medicinal value of exercise.”
Dr. Metzl, who was not involved in the study, helped develop an annual seminar at Cornell Medical School teaching medical students ways to prescribe exercise that go beyond the “30 minutes per day” cookie-cutter advice. Still, doctors and other health care professionals often struggle to prescribe exercise to prevent or treat disease. And a recent study from Oxford found that when doctors do give weight loss advice, it’s often vague and hard for patients to use.
“The drug of movement is one of the safest and most effective forms of preventive health,” says Dr. Metzl. “We need to get the medical community fully engaged in prescribing exercise for their patients.”
This study suggests that a focus on critical power could be key in making that happen.
What the research found
In the study, 22 adults completed 8 weeks of either moderate-intensity training or high-intensity interval training (HIIT). The intensity levels specified in both plans were based on VO2 max. So, the people in the study trained at given percentages of their VO2 max.
Both groups saw improvements in endurance, but results varied greatly from person to person. Those mixed results could be explained by individual differences in critical power.
“Improvement was much more correlated with the percentage of critical powers the individuals worked at rather than the percentage of their VO2max, like exercise physiologists have thought for years,” says lead study author Jessica Collins, a researcher at Brigham Young University.
Not only that but several subjects who did not improve their VO2 max did see an increase in critical power and endurance.
“People tend to only focus on VO2 max,” Dr. Gifford says. “Many might see the lack of increase in VO2 max for some people and conclude that the training was ineffective. I personally believe that a lot of potentially useful therapies have been ruled out because of an almost exclusive focus on VO2 max.”
Turns out, critical power varies a lot from person to person, even among those with similar VO2 maxes.
“Let’s say you and Jessica had the same VO2 max,” explains Dr. Gifford. “If we had you both going at 70% of [your VO2 max], it could be above your maximum steady state, which would make it really hard for you. And it could be below her maximum steady state, which would make it easy for her.”
This means you are each stressing your body differently, and that stress is what triggers improvements in fitness and endurance.
“Below critical power, the metabolic stressors are well-managed and maintained at elevated-but-steady levels,” Dr. Gifford says. “Above critical power, the metabolic stressors are produced so fast that they cannot be controlled, and consistently accrue until reaching very high levels that cause failure.”
Knowing your critical power means you can predict how those stressors will build up, and you can tailor an exercise program that provides just the right stressor “dose” for you, Dr. Gifford says.
Such programs could be used for rehab patients recovering from a heart attack or from lung disease, Dr. Gifford suggests. Or they could help older adults improve endurance and physical function, Ms. Collins notes.
But first, researchers must confirm these results by programming workouts based on people’s critical power and seeing how much different measures improve.
How to find your critical power
Critical power is not new, but exercise physiologists and medical professionals have largely ignored it because it’s not easy to measure.
“People generally train off VO2 max or maximum heart rate, which is even less precise,” Dr. Gifford says.
Finding people’s critical power in the study involved multiple timed trials and calculating the relationship between speed/power and time, Dr. Gifford explains.
But for a rough measure of your critical power, you could use an app that measures functional threshold power (FTP), something Dr. Gifford refers to as the “Walmart version” of critical power. “It’s not exactly the same, but it’s close,” he says. (The app Strava features FTP as well as a pretty sophisticated power analysis.)
Or skip the tech and go by feel. If you’re below your critical power, “it’s going to be challenging, but you’ll feel under control,” Dr. Gifford says. Above your critical power, “your breathing and heart rate will continuously climb until you fail in about 2 to 15 minutes, depending on how far above you are.” Still, you don’t need to know your critical power to start exercising, Ms. Collins notes.
“The beauty of exercise is that it is such a powerful drug that you can see benefits without fine-tuning the workout this way,” Dr. Gifford explains. “I would hate for this to become a barrier to exercising. The important thing is to do something.”
A version of this article first appeared on WebMD.com.
A new study out of Brigham Young University, Provo, Utah, suggests doctors could take that initiative to the next level, prescribing exercise plans that result in a specific health outcome; say, lowering your blood pressure or losing weight.
“The findings of this study, and others, suggest that we should be able to more consistently and accurately prescribe exercise like medicine,” says senior study author Jayson Gifford, PhD, an exercise sciences professor at BYU.
These exercise prescriptions would be tailored to patients based on a largely ignored fitness measure called critical power, or maximum steady state – the fastest you can go while maintaining a pace you can sustain for a long time.
By crafting workouts around critical power instead of the more frequently used VO2 max (maximum effort), we could more accurately predict health outcomes, just as we can with medicine, the researchers wrote in the Journal of Applied Physiology.
“We’ve known for centuries that exercise is part of the way to develop a healthy and long life,” says Jordan Metzl, MD, a sports medicine doctor at the Hospital for Special Surgery in New York and author of The Exercise Cure. “But it’s only in the past 70 years that we’ve recognized the medicinal value of exercise.”
Dr. Metzl, who was not involved in the study, helped develop an annual seminar at Cornell Medical School teaching medical students ways to prescribe exercise that go beyond the “30 minutes per day” cookie-cutter advice. Still, doctors and other health care professionals often struggle to prescribe exercise to prevent or treat disease. And a recent study from Oxford found that when doctors do give weight loss advice, it’s often vague and hard for patients to use.
“The drug of movement is one of the safest and most effective forms of preventive health,” says Dr. Metzl. “We need to get the medical community fully engaged in prescribing exercise for their patients.”
This study suggests that a focus on critical power could be key in making that happen.
What the research found
In the study, 22 adults completed 8 weeks of either moderate-intensity training or high-intensity interval training (HIIT). The intensity levels specified in both plans were based on VO2 max. So, the people in the study trained at given percentages of their VO2 max.
Both groups saw improvements in endurance, but results varied greatly from person to person. Those mixed results could be explained by individual differences in critical power.
“Improvement was much more correlated with the percentage of critical powers the individuals worked at rather than the percentage of their VO2max, like exercise physiologists have thought for years,” says lead study author Jessica Collins, a researcher at Brigham Young University.
Not only that but several subjects who did not improve their VO2 max did see an increase in critical power and endurance.
“People tend to only focus on VO2 max,” Dr. Gifford says. “Many might see the lack of increase in VO2 max for some people and conclude that the training was ineffective. I personally believe that a lot of potentially useful therapies have been ruled out because of an almost exclusive focus on VO2 max.”
Turns out, critical power varies a lot from person to person, even among those with similar VO2 maxes.
“Let’s say you and Jessica had the same VO2 max,” explains Dr. Gifford. “If we had you both going at 70% of [your VO2 max], it could be above your maximum steady state, which would make it really hard for you. And it could be below her maximum steady state, which would make it easy for her.”
This means you are each stressing your body differently, and that stress is what triggers improvements in fitness and endurance.
“Below critical power, the metabolic stressors are well-managed and maintained at elevated-but-steady levels,” Dr. Gifford says. “Above critical power, the metabolic stressors are produced so fast that they cannot be controlled, and consistently accrue until reaching very high levels that cause failure.”
Knowing your critical power means you can predict how those stressors will build up, and you can tailor an exercise program that provides just the right stressor “dose” for you, Dr. Gifford says.
Such programs could be used for rehab patients recovering from a heart attack or from lung disease, Dr. Gifford suggests. Or they could help older adults improve endurance and physical function, Ms. Collins notes.
But first, researchers must confirm these results by programming workouts based on people’s critical power and seeing how much different measures improve.
How to find your critical power
Critical power is not new, but exercise physiologists and medical professionals have largely ignored it because it’s not easy to measure.
“People generally train off VO2 max or maximum heart rate, which is even less precise,” Dr. Gifford says.
Finding people’s critical power in the study involved multiple timed trials and calculating the relationship between speed/power and time, Dr. Gifford explains.
But for a rough measure of your critical power, you could use an app that measures functional threshold power (FTP), something Dr. Gifford refers to as the “Walmart version” of critical power. “It’s not exactly the same, but it’s close,” he says. (The app Strava features FTP as well as a pretty sophisticated power analysis.)
Or skip the tech and go by feel. If you’re below your critical power, “it’s going to be challenging, but you’ll feel under control,” Dr. Gifford says. Above your critical power, “your breathing and heart rate will continuously climb until you fail in about 2 to 15 minutes, depending on how far above you are.” Still, you don’t need to know your critical power to start exercising, Ms. Collins notes.
“The beauty of exercise is that it is such a powerful drug that you can see benefits without fine-tuning the workout this way,” Dr. Gifford explains. “I would hate for this to become a barrier to exercising. The important thing is to do something.”
A version of this article first appeared on WebMD.com.
A new study out of Brigham Young University, Provo, Utah, suggests doctors could take that initiative to the next level, prescribing exercise plans that result in a specific health outcome; say, lowering your blood pressure or losing weight.
“The findings of this study, and others, suggest that we should be able to more consistently and accurately prescribe exercise like medicine,” says senior study author Jayson Gifford, PhD, an exercise sciences professor at BYU.
These exercise prescriptions would be tailored to patients based on a largely ignored fitness measure called critical power, or maximum steady state – the fastest you can go while maintaining a pace you can sustain for a long time.
By crafting workouts around critical power instead of the more frequently used VO2 max (maximum effort), we could more accurately predict health outcomes, just as we can with medicine, the researchers wrote in the Journal of Applied Physiology.
“We’ve known for centuries that exercise is part of the way to develop a healthy and long life,” says Jordan Metzl, MD, a sports medicine doctor at the Hospital for Special Surgery in New York and author of The Exercise Cure. “But it’s only in the past 70 years that we’ve recognized the medicinal value of exercise.”
Dr. Metzl, who was not involved in the study, helped develop an annual seminar at Cornell Medical School teaching medical students ways to prescribe exercise that go beyond the “30 minutes per day” cookie-cutter advice. Still, doctors and other health care professionals often struggle to prescribe exercise to prevent or treat disease. And a recent study from Oxford found that when doctors do give weight loss advice, it’s often vague and hard for patients to use.
“The drug of movement is one of the safest and most effective forms of preventive health,” says Dr. Metzl. “We need to get the medical community fully engaged in prescribing exercise for their patients.”
This study suggests that a focus on critical power could be key in making that happen.
What the research found
In the study, 22 adults completed 8 weeks of either moderate-intensity training or high-intensity interval training (HIIT). The intensity levels specified in both plans were based on VO2 max. So, the people in the study trained at given percentages of their VO2 max.
Both groups saw improvements in endurance, but results varied greatly from person to person. Those mixed results could be explained by individual differences in critical power.
“Improvement was much more correlated with the percentage of critical powers the individuals worked at rather than the percentage of their VO2max, like exercise physiologists have thought for years,” says lead study author Jessica Collins, a researcher at Brigham Young University.
Not only that but several subjects who did not improve their VO2 max did see an increase in critical power and endurance.
“People tend to only focus on VO2 max,” Dr. Gifford says. “Many might see the lack of increase in VO2 max for some people and conclude that the training was ineffective. I personally believe that a lot of potentially useful therapies have been ruled out because of an almost exclusive focus on VO2 max.”
Turns out, critical power varies a lot from person to person, even among those with similar VO2 maxes.
“Let’s say you and Jessica had the same VO2 max,” explains Dr. Gifford. “If we had you both going at 70% of [your VO2 max], it could be above your maximum steady state, which would make it really hard for you. And it could be below her maximum steady state, which would make it easy for her.”
This means you are each stressing your body differently, and that stress is what triggers improvements in fitness and endurance.
“Below critical power, the metabolic stressors are well-managed and maintained at elevated-but-steady levels,” Dr. Gifford says. “Above critical power, the metabolic stressors are produced so fast that they cannot be controlled, and consistently accrue until reaching very high levels that cause failure.”
Knowing your critical power means you can predict how those stressors will build up, and you can tailor an exercise program that provides just the right stressor “dose” for you, Dr. Gifford says.
Such programs could be used for rehab patients recovering from a heart attack or from lung disease, Dr. Gifford suggests. Or they could help older adults improve endurance and physical function, Ms. Collins notes.
But first, researchers must confirm these results by programming workouts based on people’s critical power and seeing how much different measures improve.
How to find your critical power
Critical power is not new, but exercise physiologists and medical professionals have largely ignored it because it’s not easy to measure.
“People generally train off VO2 max or maximum heart rate, which is even less precise,” Dr. Gifford says.
Finding people’s critical power in the study involved multiple timed trials and calculating the relationship between speed/power and time, Dr. Gifford explains.
But for a rough measure of your critical power, you could use an app that measures functional threshold power (FTP), something Dr. Gifford refers to as the “Walmart version” of critical power. “It’s not exactly the same, but it’s close,” he says. (The app Strava features FTP as well as a pretty sophisticated power analysis.)
Or skip the tech and go by feel. If you’re below your critical power, “it’s going to be challenging, but you’ll feel under control,” Dr. Gifford says. Above your critical power, “your breathing and heart rate will continuously climb until you fail in about 2 to 15 minutes, depending on how far above you are.” Still, you don’t need to know your critical power to start exercising, Ms. Collins notes.
“The beauty of exercise is that it is such a powerful drug that you can see benefits without fine-tuning the workout this way,” Dr. Gifford explains. “I would hate for this to become a barrier to exercising. The important thing is to do something.”
A version of this article first appeared on WebMD.com.
FROM THE JOURNAL OF APPLIED PHYSIOLOGY
‘Low-value’ prostate cancer screening prevalent in primary care
Yet a new study shows that testing for prostate-specific antigen (PSA) and also digital rectal examinations (DRE) are both carried out frequently in older men, even when there is no indication for such testing.
“As a man ages, the risk for a false-positive result increases,” said lead author Chris Gillette, PhD, associate professor of physician assistant studies at Wake Forest University, Winston-Salem, N.C., in a statement
The study authors looked at primary care visits for men who were age 70 or older, and found that, per 100 visits, there were 6.7 PSA tests and 1.6 DRE performed.
Dr. Gillette and colleagues emphasized the importance of their findings. Whereas prior studies have relied on commercially insured men or patient-reported rates of PSA testing, they used a nationally representative clinical dataset that is much more inclusive, as it includes men who are also uninsured or insured through traditional Medicare.
The study was published online in the Journal of the American Board of Family Medicine.
Screening for prostate cancer has been much debated, and the guidelines have changed in recent years. In the period 2012-2018, the U.S. Preventive Services Task Force recommended against PSA-based screening in all men, but then the guidelines changed, and the USPSTF subsequently endorsed individualized screening in those aged 55-69 years after a shared decision-making discussion. That same 2018 update also recommends against PSA screening in men over the age of 70.
In addition, the American Urological Association has recommended against PSA-based prostate cancer screening for men over the age of 70 since 2013.
Previous studies have shown that clinicians are not adhering to the guidelines. An analysis conducted in March 2022 found that about one in four accredited U.S. cancer centers fails to follow national guidelines for PSA testing to screen for prostate cancer. Contrary to national guidelines, which advocate shared decision-making, 22% of centers recommend all men universally initiate PSA screening at either age 50 or 55 and another 4% of centers recommend this before age 50, earlier than the guidelines advise.
In the current study, Dr. Gillette and colleagues conducted a secondary analysis of the National Ambulatory Medical Care Survey datasets from 2013 to 2016 and 2018. The dataset is a nationally representative sample of visits to nonfederal, office-based physician clinics. This analysis was restricted to male patients aged 70 years and older who visited a primary care clinic.
The team found that health care professionals who order a lot of tests are more likely to order low-value screening such as PSA and DRE.
The data also showed that when there were a higher number of services ordered/provided, the patients were significantly more likely to receive a low-value PSA (odds ratio, 1.49) and a low-value DRE (OR, 1.37). In contrast, patients who had more previous visits to the clinician were less likely to receive a low-value DRE (OR, 0.92).
Overall, there a decline in low-value PSA screening after 2014, but this trend was not seen for DRE during primary care visits.
Speculating as to why these low-value tests are being carried out, Dr. Gillette suggested that health care professionals might be responding to patient requests when ordering these screening tests, or they may be using what’s known as a “shotgun” approach to medical testing where all possible tests are ordered during a medical visit.
“However, as health care systems move toward a more value-based care system – where the benefit of services provided outweighs any risks – clinicians need to engage patients in these discussions on the complexity of this testing,” he commented. “Ultimately, when and if to screen is a decision best left between a provider and the patient.”
There was no outside funding and the authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Yet a new study shows that testing for prostate-specific antigen (PSA) and also digital rectal examinations (DRE) are both carried out frequently in older men, even when there is no indication for such testing.
“As a man ages, the risk for a false-positive result increases,” said lead author Chris Gillette, PhD, associate professor of physician assistant studies at Wake Forest University, Winston-Salem, N.C., in a statement
The study authors looked at primary care visits for men who were age 70 or older, and found that, per 100 visits, there were 6.7 PSA tests and 1.6 DRE performed.
Dr. Gillette and colleagues emphasized the importance of their findings. Whereas prior studies have relied on commercially insured men or patient-reported rates of PSA testing, they used a nationally representative clinical dataset that is much more inclusive, as it includes men who are also uninsured or insured through traditional Medicare.
The study was published online in the Journal of the American Board of Family Medicine.
Screening for prostate cancer has been much debated, and the guidelines have changed in recent years. In the period 2012-2018, the U.S. Preventive Services Task Force recommended against PSA-based screening in all men, but then the guidelines changed, and the USPSTF subsequently endorsed individualized screening in those aged 55-69 years after a shared decision-making discussion. That same 2018 update also recommends against PSA screening in men over the age of 70.
In addition, the American Urological Association has recommended against PSA-based prostate cancer screening for men over the age of 70 since 2013.
Previous studies have shown that clinicians are not adhering to the guidelines. An analysis conducted in March 2022 found that about one in four accredited U.S. cancer centers fails to follow national guidelines for PSA testing to screen for prostate cancer. Contrary to national guidelines, which advocate shared decision-making, 22% of centers recommend all men universally initiate PSA screening at either age 50 or 55 and another 4% of centers recommend this before age 50, earlier than the guidelines advise.
In the current study, Dr. Gillette and colleagues conducted a secondary analysis of the National Ambulatory Medical Care Survey datasets from 2013 to 2016 and 2018. The dataset is a nationally representative sample of visits to nonfederal, office-based physician clinics. This analysis was restricted to male patients aged 70 years and older who visited a primary care clinic.
The team found that health care professionals who order a lot of tests are more likely to order low-value screening such as PSA and DRE.
The data also showed that when there were a higher number of services ordered/provided, the patients were significantly more likely to receive a low-value PSA (odds ratio, 1.49) and a low-value DRE (OR, 1.37). In contrast, patients who had more previous visits to the clinician were less likely to receive a low-value DRE (OR, 0.92).
Overall, there a decline in low-value PSA screening after 2014, but this trend was not seen for DRE during primary care visits.
Speculating as to why these low-value tests are being carried out, Dr. Gillette suggested that health care professionals might be responding to patient requests when ordering these screening tests, or they may be using what’s known as a “shotgun” approach to medical testing where all possible tests are ordered during a medical visit.
“However, as health care systems move toward a more value-based care system – where the benefit of services provided outweighs any risks – clinicians need to engage patients in these discussions on the complexity of this testing,” he commented. “Ultimately, when and if to screen is a decision best left between a provider and the patient.”
There was no outside funding and the authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Yet a new study shows that testing for prostate-specific antigen (PSA) and also digital rectal examinations (DRE) are both carried out frequently in older men, even when there is no indication for such testing.
“As a man ages, the risk for a false-positive result increases,” said lead author Chris Gillette, PhD, associate professor of physician assistant studies at Wake Forest University, Winston-Salem, N.C., in a statement
The study authors looked at primary care visits for men who were age 70 or older, and found that, per 100 visits, there were 6.7 PSA tests and 1.6 DRE performed.
Dr. Gillette and colleagues emphasized the importance of their findings. Whereas prior studies have relied on commercially insured men or patient-reported rates of PSA testing, they used a nationally representative clinical dataset that is much more inclusive, as it includes men who are also uninsured or insured through traditional Medicare.
The study was published online in the Journal of the American Board of Family Medicine.
Screening for prostate cancer has been much debated, and the guidelines have changed in recent years. In the period 2012-2018, the U.S. Preventive Services Task Force recommended against PSA-based screening in all men, but then the guidelines changed, and the USPSTF subsequently endorsed individualized screening in those aged 55-69 years after a shared decision-making discussion. That same 2018 update also recommends against PSA screening in men over the age of 70.
In addition, the American Urological Association has recommended against PSA-based prostate cancer screening for men over the age of 70 since 2013.
Previous studies have shown that clinicians are not adhering to the guidelines. An analysis conducted in March 2022 found that about one in four accredited U.S. cancer centers fails to follow national guidelines for PSA testing to screen for prostate cancer. Contrary to national guidelines, which advocate shared decision-making, 22% of centers recommend all men universally initiate PSA screening at either age 50 or 55 and another 4% of centers recommend this before age 50, earlier than the guidelines advise.
In the current study, Dr. Gillette and colleagues conducted a secondary analysis of the National Ambulatory Medical Care Survey datasets from 2013 to 2016 and 2018. The dataset is a nationally representative sample of visits to nonfederal, office-based physician clinics. This analysis was restricted to male patients aged 70 years and older who visited a primary care clinic.
The team found that health care professionals who order a lot of tests are more likely to order low-value screening such as PSA and DRE.
The data also showed that when there were a higher number of services ordered/provided, the patients were significantly more likely to receive a low-value PSA (odds ratio, 1.49) and a low-value DRE (OR, 1.37). In contrast, patients who had more previous visits to the clinician were less likely to receive a low-value DRE (OR, 0.92).
Overall, there a decline in low-value PSA screening after 2014, but this trend was not seen for DRE during primary care visits.
Speculating as to why these low-value tests are being carried out, Dr. Gillette suggested that health care professionals might be responding to patient requests when ordering these screening tests, or they may be using what’s known as a “shotgun” approach to medical testing where all possible tests are ordered during a medical visit.
“However, as health care systems move toward a more value-based care system – where the benefit of services provided outweighs any risks – clinicians need to engage patients in these discussions on the complexity of this testing,” he commented. “Ultimately, when and if to screen is a decision best left between a provider and the patient.”
There was no outside funding and the authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN BOARD OF FAMILY MEDICINE
Screen all patients for cannabis use before surgery: Guideline
All patients who undergo procedures that require regional or general anesthesia should be asked if, how often, and in what forms they use the drug, according to recommendations from the American Society of Regional Anesthesia and Pain Medicine.
One reason: Patients who regularly use cannabis may experience worse pain and nausea after surgery and may require more opioid analgesia, the group said.
The society’s recommendations – published in Regional Anesthesia and Pain Medicine – are the first guidelines in the United States to cover cannabis use as it relates to surgery, the group said.
Possible interactions
Use of cannabis has increased in recent years, and researchers have been concerned that the drug may interact with anesthesia and complicate pain management. Few studies have evaluated interactions between cannabis and anesthetic agents, however, according to the authors of the new guidelines.
“With the rising prevalence of both medical and recreational cannabis use in the general population, anesthesiologists, surgeons, and perioperative physicians must have an understanding of the effects of cannabis on physiology in order to provide safe perioperative care,” the guideline said.
“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, PhD, ASRA president and senior author of the guidelines, said in a news release about the recommendations.
Although some patients may use cannabis to relieve pain, research shows that “regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort,” said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.
Risks for vomiting, heart attack
The new recommendations were created by a committee of 13 experts, including anesthesiologists, chronic pain physicians, and a patient advocate. Shalini Shah, MD, vice chair of anesthesiology at the University of California, Irvine, was lead author of the document.
Four of 21 recommendations were classified as grade A, meaning that following them would be expected to provide substantial benefits. Those recommendations are to screen all patients before surgery; postpone elective surgery for patients who have altered mental status or impaired decision-making capacity at the time of surgery; counsel frequent, heavy users about the potential for cannabis use to impair postoperative pain control; and counsel pregnant patients about the risks of cannabis use to unborn children.
The authors cited studies to support their recommendations, including one showing that long-term cannabis use was associated with a 20% increase in the incidence of postoperative nausea and vomiting, a leading complaint of surgery patients. Other research has shown that cannabis use is linked to more pain and use of opioids after surgery.
Other recommendations include delaying elective surgery for at least 2 hours after a patient has smoked cannabis, owing to an increased risk for heart attack, and considering adjustment of ventilation settings during surgery for regular smokers of cannabis. Research has shown that smoking cannabis may be a rare trigger for myocardial infarction and is associated with airway inflammation and self-reported respiratory symptoms.
Nevertheless, doctors should not conduct universal toxicology screening, given a lack of evidence supporting this practice, the guideline stated.
The authors did not have enough information to make recommendations about reducing cannabis use before surgery or adjusting opioid prescriptions after surgery for patients who use cannabis, they said.
Kenneth Finn, MD, president of the American Board of Pain Medicine, welcomed the publication of the new guidelines. Dr. Finn, who practices at Springs Rehabilitation in Colorado Springs, has edited a textbook about cannabis in medicine and founded the International Academy on the Science and Impact of Cannabis.
“The vast majority of medical providers really have no idea about cannabis and what its impacts are on the human body,” Dr. Finn said.
For one, it can interact with numerous other drugs, including warfarin.
Guideline coauthor Eugene R. Viscusi, MD, professor of anesthesiology at the Sidney Kimmel Medical College, Philadelphia, emphasized that, while cannabis may be perceived as “natural,” it should not be considered differently from manufactured drugs.
Cannabis and cannabinoids represent “a class of very potent and pharmacologically active compounds,” Dr. Viscusi said in an interview. While researchers continue to assess possible medically beneficial effects of cannabis compounds, clinicians also need to be aware of the risks.
“The literature continues to emerge, and while we are always hopeful for good news, as physicians, we need to be very well versed on potential risks, especially in a high-risk situation like surgery,” he said.
Dr. Shah has consulted for companies that develop medical devices and drugs. Dr. Finn is the editor of the textbook, “Cannabis in Medicine: An Evidence-Based Approach” (Springer: New York, 2020), for which he receives royalties.
A version of this article first appeared on Medscape.com.
All patients who undergo procedures that require regional or general anesthesia should be asked if, how often, and in what forms they use the drug, according to recommendations from the American Society of Regional Anesthesia and Pain Medicine.
One reason: Patients who regularly use cannabis may experience worse pain and nausea after surgery and may require more opioid analgesia, the group said.
The society’s recommendations – published in Regional Anesthesia and Pain Medicine – are the first guidelines in the United States to cover cannabis use as it relates to surgery, the group said.
Possible interactions
Use of cannabis has increased in recent years, and researchers have been concerned that the drug may interact with anesthesia and complicate pain management. Few studies have evaluated interactions between cannabis and anesthetic agents, however, according to the authors of the new guidelines.
“With the rising prevalence of both medical and recreational cannabis use in the general population, anesthesiologists, surgeons, and perioperative physicians must have an understanding of the effects of cannabis on physiology in order to provide safe perioperative care,” the guideline said.
“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, PhD, ASRA president and senior author of the guidelines, said in a news release about the recommendations.
Although some patients may use cannabis to relieve pain, research shows that “regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort,” said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.
Risks for vomiting, heart attack
The new recommendations were created by a committee of 13 experts, including anesthesiologists, chronic pain physicians, and a patient advocate. Shalini Shah, MD, vice chair of anesthesiology at the University of California, Irvine, was lead author of the document.
Four of 21 recommendations were classified as grade A, meaning that following them would be expected to provide substantial benefits. Those recommendations are to screen all patients before surgery; postpone elective surgery for patients who have altered mental status or impaired decision-making capacity at the time of surgery; counsel frequent, heavy users about the potential for cannabis use to impair postoperative pain control; and counsel pregnant patients about the risks of cannabis use to unborn children.
The authors cited studies to support their recommendations, including one showing that long-term cannabis use was associated with a 20% increase in the incidence of postoperative nausea and vomiting, a leading complaint of surgery patients. Other research has shown that cannabis use is linked to more pain and use of opioids after surgery.
Other recommendations include delaying elective surgery for at least 2 hours after a patient has smoked cannabis, owing to an increased risk for heart attack, and considering adjustment of ventilation settings during surgery for regular smokers of cannabis. Research has shown that smoking cannabis may be a rare trigger for myocardial infarction and is associated with airway inflammation and self-reported respiratory symptoms.
Nevertheless, doctors should not conduct universal toxicology screening, given a lack of evidence supporting this practice, the guideline stated.
The authors did not have enough information to make recommendations about reducing cannabis use before surgery or adjusting opioid prescriptions after surgery for patients who use cannabis, they said.
Kenneth Finn, MD, president of the American Board of Pain Medicine, welcomed the publication of the new guidelines. Dr. Finn, who practices at Springs Rehabilitation in Colorado Springs, has edited a textbook about cannabis in medicine and founded the International Academy on the Science and Impact of Cannabis.
“The vast majority of medical providers really have no idea about cannabis and what its impacts are on the human body,” Dr. Finn said.
For one, it can interact with numerous other drugs, including warfarin.
Guideline coauthor Eugene R. Viscusi, MD, professor of anesthesiology at the Sidney Kimmel Medical College, Philadelphia, emphasized that, while cannabis may be perceived as “natural,” it should not be considered differently from manufactured drugs.
Cannabis and cannabinoids represent “a class of very potent and pharmacologically active compounds,” Dr. Viscusi said in an interview. While researchers continue to assess possible medically beneficial effects of cannabis compounds, clinicians also need to be aware of the risks.
“The literature continues to emerge, and while we are always hopeful for good news, as physicians, we need to be very well versed on potential risks, especially in a high-risk situation like surgery,” he said.
Dr. Shah has consulted for companies that develop medical devices and drugs. Dr. Finn is the editor of the textbook, “Cannabis in Medicine: An Evidence-Based Approach” (Springer: New York, 2020), for which he receives royalties.
A version of this article first appeared on Medscape.com.
All patients who undergo procedures that require regional or general anesthesia should be asked if, how often, and in what forms they use the drug, according to recommendations from the American Society of Regional Anesthesia and Pain Medicine.
One reason: Patients who regularly use cannabis may experience worse pain and nausea after surgery and may require more opioid analgesia, the group said.
The society’s recommendations – published in Regional Anesthesia and Pain Medicine – are the first guidelines in the United States to cover cannabis use as it relates to surgery, the group said.
Possible interactions
Use of cannabis has increased in recent years, and researchers have been concerned that the drug may interact with anesthesia and complicate pain management. Few studies have evaluated interactions between cannabis and anesthetic agents, however, according to the authors of the new guidelines.
“With the rising prevalence of both medical and recreational cannabis use in the general population, anesthesiologists, surgeons, and perioperative physicians must have an understanding of the effects of cannabis on physiology in order to provide safe perioperative care,” the guideline said.
“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, PhD, ASRA president and senior author of the guidelines, said in a news release about the recommendations.
Although some patients may use cannabis to relieve pain, research shows that “regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort,” said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.
Risks for vomiting, heart attack
The new recommendations were created by a committee of 13 experts, including anesthesiologists, chronic pain physicians, and a patient advocate. Shalini Shah, MD, vice chair of anesthesiology at the University of California, Irvine, was lead author of the document.
Four of 21 recommendations were classified as grade A, meaning that following them would be expected to provide substantial benefits. Those recommendations are to screen all patients before surgery; postpone elective surgery for patients who have altered mental status or impaired decision-making capacity at the time of surgery; counsel frequent, heavy users about the potential for cannabis use to impair postoperative pain control; and counsel pregnant patients about the risks of cannabis use to unborn children.
The authors cited studies to support their recommendations, including one showing that long-term cannabis use was associated with a 20% increase in the incidence of postoperative nausea and vomiting, a leading complaint of surgery patients. Other research has shown that cannabis use is linked to more pain and use of opioids after surgery.
Other recommendations include delaying elective surgery for at least 2 hours after a patient has smoked cannabis, owing to an increased risk for heart attack, and considering adjustment of ventilation settings during surgery for regular smokers of cannabis. Research has shown that smoking cannabis may be a rare trigger for myocardial infarction and is associated with airway inflammation and self-reported respiratory symptoms.
Nevertheless, doctors should not conduct universal toxicology screening, given a lack of evidence supporting this practice, the guideline stated.
The authors did not have enough information to make recommendations about reducing cannabis use before surgery or adjusting opioid prescriptions after surgery for patients who use cannabis, they said.
Kenneth Finn, MD, president of the American Board of Pain Medicine, welcomed the publication of the new guidelines. Dr. Finn, who practices at Springs Rehabilitation in Colorado Springs, has edited a textbook about cannabis in medicine and founded the International Academy on the Science and Impact of Cannabis.
“The vast majority of medical providers really have no idea about cannabis and what its impacts are on the human body,” Dr. Finn said.
For one, it can interact with numerous other drugs, including warfarin.
Guideline coauthor Eugene R. Viscusi, MD, professor of anesthesiology at the Sidney Kimmel Medical College, Philadelphia, emphasized that, while cannabis may be perceived as “natural,” it should not be considered differently from manufactured drugs.
Cannabis and cannabinoids represent “a class of very potent and pharmacologically active compounds,” Dr. Viscusi said in an interview. While researchers continue to assess possible medically beneficial effects of cannabis compounds, clinicians also need to be aware of the risks.
“The literature continues to emerge, and while we are always hopeful for good news, as physicians, we need to be very well versed on potential risks, especially in a high-risk situation like surgery,” he said.
Dr. Shah has consulted for companies that develop medical devices and drugs. Dr. Finn is the editor of the textbook, “Cannabis in Medicine: An Evidence-Based Approach” (Springer: New York, 2020), for which he receives royalties.
A version of this article first appeared on Medscape.com.
FROM REGIONAL ANETHESIA AND MEDICINE
More evidence suicidal thoughts, behaviors are genetically based
“It’s really important for us to continue to study the genetic risk factors for suicidal behaviors so we can really understand the biology and develop better treatments,” study investigator Allison E. Ashley-Koch, PhD, professor in the department of medicine at Duke University Medical Center, Durham, N.C., told this news organization.
The findings were published online in JAMA Psychiatry).
SITB heritability
Suicide is a leading cause of death, particularly among individuals aged 15-29 years. Whereas the global rate of suicide has decreased by 36% in the past 20 years, the rate in the United States has increased by 35%, with the greatest rise in military veterans.
Twin studies suggest heritability for SITB is between 30% and 55%, but the molecular genetic basis of SITB remains elusive.
To address this research gap, investigators conducted a study of 633,778 U.S. military veterans from the Million Veteran Program (MVP) cohort. Of these, 71% had European ancestry, 19% had African ancestry, 8% were Hispanic, and 1% were Asian. Just under 10% of the sample was female.
Study participants donated a blood sample and agreed to have their genetic information linked with their electronic health record data.
From diagnostic codes and other sources, researchers identified 121,211 individuals with SITB. They classified participants with no documented lifetime history of suicidal ideation, suicide attempt, or suicide death as controls.
Rates of SITB differed significantly by ancestry – 25% in those with African or Hispanic ancestry, 21% in those with Asian ancestry, and 16.8% in those with European ancestry. Rates also differed by age and sex; those with SITB were younger and more likely to be female.
In addition to age and sex, covariates included “genetic principal components,” which Dr. Ashley-Koch said accounts for combining data of individuals with different ethnic/racial backgrounds.
Through meta-analysis, the investigators identified seven genome-wide, significant cross-ancestry risk loci.
To evaluate whether the findings could be replicated, researchers used the International Suicide Genetics Consortium (ISGC), a primarily civilian international consortium of roughly 550,000 individuals of mostly European ancestry.
The analysis showed the top replicated cross-ancestry risk locus was rs6557168, an intronic single-nucleotide variant (SNV) in the ESR1 gene that encodes an estrogen receptor. Previous work identified ESR1 as a causal genetic driver gene for development of posttraumatic stress disorder and depression, both of which are risk factors for SITB among veterans.
The second-strongest replicated cross-ancestry locus was rs12808482, an intronic variant in the DRD2 gene, which encodes the D2 dopamine-receptor subtype. The authors noted DRD2 is highly expressed in brain tissue and has been associated with numerous psychiatric phenotypes.
Research suggests DRD2 is associated with other risk factors for SITB, such as schizophrenia, mood disorders, and attention-deficit/hyperactivity disorder, but DRD2 could also contribute to suicide risk directly. The authors noted it is highly expressed in the prefrontal cortex, nucleus accumbens, substantia nigra, and hippocampus.
Outstanding candidate gene
The study revealed a cross-ancestry GWS association for rs10671545, a variant in DCC, which is “also an outstanding candidate gene,” the investigators write.
They note it is expressed in brain tissue, is involved in synaptic plasticity, axon guidance, and circadian entrainment, and has been associated with multiple psychiatric phenotypes.
Researchers also found what they called “intriguing” cross-ancestry GWS associations for the TRAF3 gene, which regulates type-1 interferon production. Many patients receiving interferon therapy develop major depressive disorder and suicidal ideation.
TRAF3 is also associated with antisocial behavior, substance use, and ADHD. Lithium – a standard treatment for bipolar disorder that reduces suicide risk – modulates the expression of TRAF3.
Dr. Ashley-Koch noted the replication of these loci (ESR1, DRD2, TRAF3, and DCC) was in a population of mostly White civilians. “This suggests to us that at least some of the risk for suicidal thoughts and behaviors does cross ancestry and also crosses military and civilian populations.”
It was “exciting” that all four genes the study focused on had previously been implicated in other psychiatric disorders, said Dr. Ashley-Koch. “What gave us a little more confidence, above and beyond the replication, was that these genes are somehow important for psychiatric disorders, and not any psychiatric disorders, but the ones that are also associated with a high risk of suicide behavior, such as depression, PTSD, schizophrenia, and ADHD.”
The findings will not have an immediate impact on clinical practice, said Dr. Ashley-Koch.
“We need to take the next step, which is to try to understand how these genetic factors may impact risk and what else is happening biologically to increase that risk. Then once we do that, hopefully we can develop some new treatments,” she added.
‘Valuable and noble’ research
Commenting on the study, Elspeth Cameron Ritchie, MD, chief of psychiatry at Medstar Washington Hospital Center, Washington, said this kind of genetic research is “valuable and noble.”
Researchers have long been interested in risk factors for suicide among military personnel and veterans, said Dr. Ritchie. Evidence to date suggests being a young male is a risk factor as is feeling excluded or not fitting into the unit, and drug or alcohol addiction.
Dr. Ritchie noted other psychiatric disorders, including schizophrenia, depression, and bipolar disorder, are at least partially inherited.
She noted the study’s findings should not be used to discriminate against those who might have the identified genetic loci without clearer evidence of their impact.
“If we were able to identify these genes, would we start screening everybody who joins the military to see if they have these genes, and how would that impact the ability to recruit or retain personnel?”
She agreed additional work is needed to determine if and how carrying these genes might impact clinical care.
In addition, she pointed out that behavior is influenced not only by genetic load but also by environment. “This study may show the impact of the genetic load a little bit more clearly; right now, we tend to look at environmental factors.”
The study was supported by an award from the Clinical Science Research and Development (CSR&D) service of the Veterans Health Administration’s Office of Research and Development. The work was also supported in part by the joint U.S. Department of Veterans Affairs and U.S. Department of Energy MVP CHAMPION program.
Dr. Ashley-Koch reported grants from Veterans Administration during the conduct of the study. Several other coauthors report relationships with industry, nonprofit organizations, and government agencies. The full list can be found with the original article. Dr. Ritchie reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“It’s really important for us to continue to study the genetic risk factors for suicidal behaviors so we can really understand the biology and develop better treatments,” study investigator Allison E. Ashley-Koch, PhD, professor in the department of medicine at Duke University Medical Center, Durham, N.C., told this news organization.
The findings were published online in JAMA Psychiatry).
SITB heritability
Suicide is a leading cause of death, particularly among individuals aged 15-29 years. Whereas the global rate of suicide has decreased by 36% in the past 20 years, the rate in the United States has increased by 35%, with the greatest rise in military veterans.
Twin studies suggest heritability for SITB is between 30% and 55%, but the molecular genetic basis of SITB remains elusive.
To address this research gap, investigators conducted a study of 633,778 U.S. military veterans from the Million Veteran Program (MVP) cohort. Of these, 71% had European ancestry, 19% had African ancestry, 8% were Hispanic, and 1% were Asian. Just under 10% of the sample was female.
Study participants donated a blood sample and agreed to have their genetic information linked with their electronic health record data.
From diagnostic codes and other sources, researchers identified 121,211 individuals with SITB. They classified participants with no documented lifetime history of suicidal ideation, suicide attempt, or suicide death as controls.
Rates of SITB differed significantly by ancestry – 25% in those with African or Hispanic ancestry, 21% in those with Asian ancestry, and 16.8% in those with European ancestry. Rates also differed by age and sex; those with SITB were younger and more likely to be female.
In addition to age and sex, covariates included “genetic principal components,” which Dr. Ashley-Koch said accounts for combining data of individuals with different ethnic/racial backgrounds.
Through meta-analysis, the investigators identified seven genome-wide, significant cross-ancestry risk loci.
To evaluate whether the findings could be replicated, researchers used the International Suicide Genetics Consortium (ISGC), a primarily civilian international consortium of roughly 550,000 individuals of mostly European ancestry.
The analysis showed the top replicated cross-ancestry risk locus was rs6557168, an intronic single-nucleotide variant (SNV) in the ESR1 gene that encodes an estrogen receptor. Previous work identified ESR1 as a causal genetic driver gene for development of posttraumatic stress disorder and depression, both of which are risk factors for SITB among veterans.
The second-strongest replicated cross-ancestry locus was rs12808482, an intronic variant in the DRD2 gene, which encodes the D2 dopamine-receptor subtype. The authors noted DRD2 is highly expressed in brain tissue and has been associated with numerous psychiatric phenotypes.
Research suggests DRD2 is associated with other risk factors for SITB, such as schizophrenia, mood disorders, and attention-deficit/hyperactivity disorder, but DRD2 could also contribute to suicide risk directly. The authors noted it is highly expressed in the prefrontal cortex, nucleus accumbens, substantia nigra, and hippocampus.
Outstanding candidate gene
The study revealed a cross-ancestry GWS association for rs10671545, a variant in DCC, which is “also an outstanding candidate gene,” the investigators write.
They note it is expressed in brain tissue, is involved in synaptic plasticity, axon guidance, and circadian entrainment, and has been associated with multiple psychiatric phenotypes.
Researchers also found what they called “intriguing” cross-ancestry GWS associations for the TRAF3 gene, which regulates type-1 interferon production. Many patients receiving interferon therapy develop major depressive disorder and suicidal ideation.
TRAF3 is also associated with antisocial behavior, substance use, and ADHD. Lithium – a standard treatment for bipolar disorder that reduces suicide risk – modulates the expression of TRAF3.
Dr. Ashley-Koch noted the replication of these loci (ESR1, DRD2, TRAF3, and DCC) was in a population of mostly White civilians. “This suggests to us that at least some of the risk for suicidal thoughts and behaviors does cross ancestry and also crosses military and civilian populations.”
It was “exciting” that all four genes the study focused on had previously been implicated in other psychiatric disorders, said Dr. Ashley-Koch. “What gave us a little more confidence, above and beyond the replication, was that these genes are somehow important for psychiatric disorders, and not any psychiatric disorders, but the ones that are also associated with a high risk of suicide behavior, such as depression, PTSD, schizophrenia, and ADHD.”
The findings will not have an immediate impact on clinical practice, said Dr. Ashley-Koch.
“We need to take the next step, which is to try to understand how these genetic factors may impact risk and what else is happening biologically to increase that risk. Then once we do that, hopefully we can develop some new treatments,” she added.
‘Valuable and noble’ research
Commenting on the study, Elspeth Cameron Ritchie, MD, chief of psychiatry at Medstar Washington Hospital Center, Washington, said this kind of genetic research is “valuable and noble.”
Researchers have long been interested in risk factors for suicide among military personnel and veterans, said Dr. Ritchie. Evidence to date suggests being a young male is a risk factor as is feeling excluded or not fitting into the unit, and drug or alcohol addiction.
Dr. Ritchie noted other psychiatric disorders, including schizophrenia, depression, and bipolar disorder, are at least partially inherited.
She noted the study’s findings should not be used to discriminate against those who might have the identified genetic loci without clearer evidence of their impact.
“If we were able to identify these genes, would we start screening everybody who joins the military to see if they have these genes, and how would that impact the ability to recruit or retain personnel?”
She agreed additional work is needed to determine if and how carrying these genes might impact clinical care.
In addition, she pointed out that behavior is influenced not only by genetic load but also by environment. “This study may show the impact of the genetic load a little bit more clearly; right now, we tend to look at environmental factors.”
The study was supported by an award from the Clinical Science Research and Development (CSR&D) service of the Veterans Health Administration’s Office of Research and Development. The work was also supported in part by the joint U.S. Department of Veterans Affairs and U.S. Department of Energy MVP CHAMPION program.
Dr. Ashley-Koch reported grants from Veterans Administration during the conduct of the study. Several other coauthors report relationships with industry, nonprofit organizations, and government agencies. The full list can be found with the original article. Dr. Ritchie reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“It’s really important for us to continue to study the genetic risk factors for suicidal behaviors so we can really understand the biology and develop better treatments,” study investigator Allison E. Ashley-Koch, PhD, professor in the department of medicine at Duke University Medical Center, Durham, N.C., told this news organization.
The findings were published online in JAMA Psychiatry).
SITB heritability
Suicide is a leading cause of death, particularly among individuals aged 15-29 years. Whereas the global rate of suicide has decreased by 36% in the past 20 years, the rate in the United States has increased by 35%, with the greatest rise in military veterans.
Twin studies suggest heritability for SITB is between 30% and 55%, but the molecular genetic basis of SITB remains elusive.
To address this research gap, investigators conducted a study of 633,778 U.S. military veterans from the Million Veteran Program (MVP) cohort. Of these, 71% had European ancestry, 19% had African ancestry, 8% were Hispanic, and 1% were Asian. Just under 10% of the sample was female.
Study participants donated a blood sample and agreed to have their genetic information linked with their electronic health record data.
From diagnostic codes and other sources, researchers identified 121,211 individuals with SITB. They classified participants with no documented lifetime history of suicidal ideation, suicide attempt, or suicide death as controls.
Rates of SITB differed significantly by ancestry – 25% in those with African or Hispanic ancestry, 21% in those with Asian ancestry, and 16.8% in those with European ancestry. Rates also differed by age and sex; those with SITB were younger and more likely to be female.
In addition to age and sex, covariates included “genetic principal components,” which Dr. Ashley-Koch said accounts for combining data of individuals with different ethnic/racial backgrounds.
Through meta-analysis, the investigators identified seven genome-wide, significant cross-ancestry risk loci.
To evaluate whether the findings could be replicated, researchers used the International Suicide Genetics Consortium (ISGC), a primarily civilian international consortium of roughly 550,000 individuals of mostly European ancestry.
The analysis showed the top replicated cross-ancestry risk locus was rs6557168, an intronic single-nucleotide variant (SNV) in the ESR1 gene that encodes an estrogen receptor. Previous work identified ESR1 as a causal genetic driver gene for development of posttraumatic stress disorder and depression, both of which are risk factors for SITB among veterans.
The second-strongest replicated cross-ancestry locus was rs12808482, an intronic variant in the DRD2 gene, which encodes the D2 dopamine-receptor subtype. The authors noted DRD2 is highly expressed in brain tissue and has been associated with numerous psychiatric phenotypes.
Research suggests DRD2 is associated with other risk factors for SITB, such as schizophrenia, mood disorders, and attention-deficit/hyperactivity disorder, but DRD2 could also contribute to suicide risk directly. The authors noted it is highly expressed in the prefrontal cortex, nucleus accumbens, substantia nigra, and hippocampus.
Outstanding candidate gene
The study revealed a cross-ancestry GWS association for rs10671545, a variant in DCC, which is “also an outstanding candidate gene,” the investigators write.
They note it is expressed in brain tissue, is involved in synaptic plasticity, axon guidance, and circadian entrainment, and has been associated with multiple psychiatric phenotypes.
Researchers also found what they called “intriguing” cross-ancestry GWS associations for the TRAF3 gene, which regulates type-1 interferon production. Many patients receiving interferon therapy develop major depressive disorder and suicidal ideation.
TRAF3 is also associated with antisocial behavior, substance use, and ADHD. Lithium – a standard treatment for bipolar disorder that reduces suicide risk – modulates the expression of TRAF3.
Dr. Ashley-Koch noted the replication of these loci (ESR1, DRD2, TRAF3, and DCC) was in a population of mostly White civilians. “This suggests to us that at least some of the risk for suicidal thoughts and behaviors does cross ancestry and also crosses military and civilian populations.”
It was “exciting” that all four genes the study focused on had previously been implicated in other psychiatric disorders, said Dr. Ashley-Koch. “What gave us a little more confidence, above and beyond the replication, was that these genes are somehow important for psychiatric disorders, and not any psychiatric disorders, but the ones that are also associated with a high risk of suicide behavior, such as depression, PTSD, schizophrenia, and ADHD.”
The findings will not have an immediate impact on clinical practice, said Dr. Ashley-Koch.
“We need to take the next step, which is to try to understand how these genetic factors may impact risk and what else is happening biologically to increase that risk. Then once we do that, hopefully we can develop some new treatments,” she added.
‘Valuable and noble’ research
Commenting on the study, Elspeth Cameron Ritchie, MD, chief of psychiatry at Medstar Washington Hospital Center, Washington, said this kind of genetic research is “valuable and noble.”
Researchers have long been interested in risk factors for suicide among military personnel and veterans, said Dr. Ritchie. Evidence to date suggests being a young male is a risk factor as is feeling excluded or not fitting into the unit, and drug or alcohol addiction.
Dr. Ritchie noted other psychiatric disorders, including schizophrenia, depression, and bipolar disorder, are at least partially inherited.
She noted the study’s findings should not be used to discriminate against those who might have the identified genetic loci without clearer evidence of their impact.
“If we were able to identify these genes, would we start screening everybody who joins the military to see if they have these genes, and how would that impact the ability to recruit or retain personnel?”
She agreed additional work is needed to determine if and how carrying these genes might impact clinical care.
In addition, she pointed out that behavior is influenced not only by genetic load but also by environment. “This study may show the impact of the genetic load a little bit more clearly; right now, we tend to look at environmental factors.”
The study was supported by an award from the Clinical Science Research and Development (CSR&D) service of the Veterans Health Administration’s Office of Research and Development. The work was also supported in part by the joint U.S. Department of Veterans Affairs and U.S. Department of Energy MVP CHAMPION program.
Dr. Ashley-Koch reported grants from Veterans Administration during the conduct of the study. Several other coauthors report relationships with industry, nonprofit organizations, and government agencies. The full list can be found with the original article. Dr. Ritchie reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Is thrombolysis safe for stroke patients on DOACs?
, a new study has found.
The study, the largest ever regarding the safety of thrombolysis in patients on DOACs, actually found a lower rate of sICH among patients taking DOACs than among those not taking anticoagulants.
“Thrombolysis is a backbone therapy in stroke, but the large population of patients who take DOACs are currently excluded from this treatment because DOAC use is a contraindication to treatment with thrombolysis. This is based on the presumption of an increased risk of sICH, but data to support or refute this presumption are lacking,” said senior author David J. Seiffge, MD, Bern University Hospital, Switzerland.
“Our results suggest that current guidelines need to be revised to remove the absolute contraindication of thrombolysis in patients on DOACs. The guidelines need to be more liberal on the use of thrombolysis in these patients,” he added.
“This study provides the basis for extending vital thrombolysis treatment to this substantial population of patients who take DOACs,” Dr. Seiffge said.
He estimates that 1 of every 6 stroke patients are taking a DOAC and that 1% to 2% of patients taking DOACs have a stroke each year. “As millions of patients are on DOACs, this is a large number of people who are not getting potentially life-saving thrombolysis therapy.”
Dr. Seiffge comments: “In our hospital we see at least one stroke patient on DOACs every day. It is a very frequent scenario. With this new data, we believe many of these patients could now benefit from thrombolysis without an increased bleeding risk.”
The study was published online in JAMA Neurology.
An international investigation
While thrombolysis is currently contraindicated for patients taking DOACs, some clinicians still administer thrombolysis to these patients. Different selection strategies are used, including the use of DOAC reversal agents prior to thrombolysis or the selection of patients with low anticoagulant activity, the authors noted.
The current study involved an international collaboration. The investigators compared the risk of sICH among patients who had recently taken DOACs and who underwent thrombolysis as treatment for acute ischemic stroke with the risk among control stroke patients who underwent thrombolysis but who had not been taking DOACs.
Potential contributing centers were identified by a systematic search of the literature based on published studies on the use of thrombolysis for patients who had recently taken DOACs or prospective stroke registries that may include patients who had recently taken DOACs.
The study included 832 patients from 64 centers worldwide who were confirmed to have taken a DOAC within 48 hours of receiving thrombolysis for acute ischemic stroke. The comparison group was made up of 32,375 patients who had experienced ischemic stroke that was treated with thrombolysis but who had received no prior anticoagulation therapy.
Compared with control patients, patients who had recently taken DOACs were older; the incidence of hypertension among them was higher; they had a higher degree of prestroke disability; they were less likely to be smokers; the time from symptom onset to treatment was longer; they had experienced more severe stroke; and they were more likely to have a large-vessel occlusion.
Of the patients taking DOACs, 30.3% received DOAC reversal prior to thrombolysis. For 27.0%, DOAC plasma levels were measured. The remainder were treated with thrombolysis without either of these selection methods.
Results showed that the unadjusted rate of sICH was 2.5% among patients taking DOACs, compared with 4.1% among control patients who were not taking anticoagulants.
After adjustment for stroke severity and other baseline sICH predictors, patients who had recently taken DOACs and who received thrombolysis had lower odds of developing sICH (adjusted odds ratio, 0.57; 95% confidence interval, 0.36-0.92; P = .02).
There was no difference between the selection strategies, and results were consistent in different sensitivity analyses.
The secondary outcome of any ICH occurred in 18.0% in patients taking DOACs, compared with 17.4% among control patients who used no anticoagulants. After adjustment, there was no difference in the odds for any ICH between the groups (aOR, 1.18; 95% CI, 0.95-1.45; P = .14).
The unadjusted rate of functional independence was 45% among patients taking DOACs, compared with 57% among control patients. After adjustment, patients who had recently taken DOACs and who underwent thrombolysis had numerically higher odds of being functionally independent than control patients, although this difference did not reach statistical significance (aOR, 1.13; 95% CI, 0.94-1.36; P = .20).
The association of DOAC therapy with lower odds of sICH remained when mechanical thrombectomy, large-vessel occlusion, or concomitant antiplatelet therapy was added to the model.
“This is by far the largest study to look at this issue of thrombolytic use in patients on DOACs, and we did not find any group on DOACs that had an excess ICH rate with thrombolysis,” Dr. Seiffge said,
He explained that receiving warfarin was at one time an absolute contraindication for thrombolysis, but after a 2014 study suggested that the risk was not increased for patients with an international normalized ratio below 117, this was downgraded to a relative contraindication.
“We think our study is comparable and should lead to a guideline change,” Dr. Seiffge commented.
“A relative contraindication allows clinicians the space to make a considered decision on an individual basis,” he added.
Dr. Seiffge said that at his hospital, local guidelines regarding this issue have already been changed on the basis of these data, and use of DOACs is now considered a relative contraindication.
“International guidelines can take years to update, so in the meantime, I think other centers will also go ahead with a more liberal approach. There are always some centers that are ahead of the guidelines,” he added.
Although the lower risk of sICH seen in patients who have recently used DOACs seems counterintuitive at first glance, there could be a pathophysiologic explanation for this finding, the authors suggest.
They point out that thrombin inhibition, either directly or via the coagulation cascade, might be protective against the occurrence of sICH.
“Anticoagulants may allow the clot to respond better to thrombolysis – the clot is not as solid and is easier to recanalize. This leads to smaller strokes and a lower bleeding risk. Thrombin generation is also a major driver for blood brain barrier breakdown. DOACs reduce thrombin generation, so reduce blood brain barrier breakdown and reduce bleeding,” Dr. Seiffge explained. “But these are hypotheses,” he added.
Study ‘meaningfully advances the field’
In an accompanying editorial, Eva A. Mistry, MBBS, University of Cincinnati, said the current study “meaningfully advances the field” and provides an estimation of safety of intravenous thrombolysis among patients who have taken DOACs within 48 hours of hospital admission.
She lists strengths of the study as inclusion of a large number of patients across several geographically diverse institutions with heterogeneous standard practices for thrombolysis with recent DOAC use and narrow confidence intervals regarding observed rates of sICH.
“Further, the upper bound of this confidence interval for the DOAC group is below 4%, which is a welcome result and provides supportive data for clinicians who already practice thrombolysis for patients with recent DOAC ingestion,” Dr. Mistry adds.
However, she points out several study limitations, which she says limit immediate, widespread clinical applicability.
These include use of a nonconcurrent control population, which included patients from centers that did not contribute to the DOAC group and the inclusion of Asian patients who likely received a lower thrombolytic dose.
Dr. Seiffge noted that the researchers did adjust for Asian patients but not for the thrombolytic dosage. “I personally do not think this affects the results, as Asian patients have a lower dosage because they have a higher bleeding risk. The lower bleeding risk with DOACs was seen in all continents.”
Dr. Mistry also suggests that the DOAC group itself is prone to selection bias from preferential thrombolysis of patients receiving DOAC who are at lower risk of sICH.
But Dr. Seiffge argued: “I think, actually, the opposite is true. The DOAC patients were older, had more severe comorbidities, and an increased bleeding risk.”
Dr. Mistry concluded, “Despite the limitations of the study design and enrolled population, these data may be used by clinicians to make individualized decisions regarding thrombolysis among patients with recent DOAC use. Importantly, this study lays the foundation for prospective, well-powered studies that definitively determine the safety of thrombolysis in this population.”
The study was supported by a grant from the Bangerter-Rhyner Foundation. Dr. Seiffge received grants from Bangerter Rhyner Foundation during the conduct of the study and personal fees from Bayer, Alexion, and VarmX outside the submitted work. Dr. Mistry receives grant funding from the National Institute of Neurological Disorders and Stroke and serves as a consultant for RAPID AI.
A version of this article first appeared on Medscape.com.
, a new study has found.
The study, the largest ever regarding the safety of thrombolysis in patients on DOACs, actually found a lower rate of sICH among patients taking DOACs than among those not taking anticoagulants.
“Thrombolysis is a backbone therapy in stroke, but the large population of patients who take DOACs are currently excluded from this treatment because DOAC use is a contraindication to treatment with thrombolysis. This is based on the presumption of an increased risk of sICH, but data to support or refute this presumption are lacking,” said senior author David J. Seiffge, MD, Bern University Hospital, Switzerland.
“Our results suggest that current guidelines need to be revised to remove the absolute contraindication of thrombolysis in patients on DOACs. The guidelines need to be more liberal on the use of thrombolysis in these patients,” he added.
“This study provides the basis for extending vital thrombolysis treatment to this substantial population of patients who take DOACs,” Dr. Seiffge said.
He estimates that 1 of every 6 stroke patients are taking a DOAC and that 1% to 2% of patients taking DOACs have a stroke each year. “As millions of patients are on DOACs, this is a large number of people who are not getting potentially life-saving thrombolysis therapy.”
Dr. Seiffge comments: “In our hospital we see at least one stroke patient on DOACs every day. It is a very frequent scenario. With this new data, we believe many of these patients could now benefit from thrombolysis without an increased bleeding risk.”
The study was published online in JAMA Neurology.
An international investigation
While thrombolysis is currently contraindicated for patients taking DOACs, some clinicians still administer thrombolysis to these patients. Different selection strategies are used, including the use of DOAC reversal agents prior to thrombolysis or the selection of patients with low anticoagulant activity, the authors noted.
The current study involved an international collaboration. The investigators compared the risk of sICH among patients who had recently taken DOACs and who underwent thrombolysis as treatment for acute ischemic stroke with the risk among control stroke patients who underwent thrombolysis but who had not been taking DOACs.
Potential contributing centers were identified by a systematic search of the literature based on published studies on the use of thrombolysis for patients who had recently taken DOACs or prospective stroke registries that may include patients who had recently taken DOACs.
The study included 832 patients from 64 centers worldwide who were confirmed to have taken a DOAC within 48 hours of receiving thrombolysis for acute ischemic stroke. The comparison group was made up of 32,375 patients who had experienced ischemic stroke that was treated with thrombolysis but who had received no prior anticoagulation therapy.
Compared with control patients, patients who had recently taken DOACs were older; the incidence of hypertension among them was higher; they had a higher degree of prestroke disability; they were less likely to be smokers; the time from symptom onset to treatment was longer; they had experienced more severe stroke; and they were more likely to have a large-vessel occlusion.
Of the patients taking DOACs, 30.3% received DOAC reversal prior to thrombolysis. For 27.0%, DOAC plasma levels were measured. The remainder were treated with thrombolysis without either of these selection methods.
Results showed that the unadjusted rate of sICH was 2.5% among patients taking DOACs, compared with 4.1% among control patients who were not taking anticoagulants.
After adjustment for stroke severity and other baseline sICH predictors, patients who had recently taken DOACs and who received thrombolysis had lower odds of developing sICH (adjusted odds ratio, 0.57; 95% confidence interval, 0.36-0.92; P = .02).
There was no difference between the selection strategies, and results were consistent in different sensitivity analyses.
The secondary outcome of any ICH occurred in 18.0% in patients taking DOACs, compared with 17.4% among control patients who used no anticoagulants. After adjustment, there was no difference in the odds for any ICH between the groups (aOR, 1.18; 95% CI, 0.95-1.45; P = .14).
The unadjusted rate of functional independence was 45% among patients taking DOACs, compared with 57% among control patients. After adjustment, patients who had recently taken DOACs and who underwent thrombolysis had numerically higher odds of being functionally independent than control patients, although this difference did not reach statistical significance (aOR, 1.13; 95% CI, 0.94-1.36; P = .20).
The association of DOAC therapy with lower odds of sICH remained when mechanical thrombectomy, large-vessel occlusion, or concomitant antiplatelet therapy was added to the model.
“This is by far the largest study to look at this issue of thrombolytic use in patients on DOACs, and we did not find any group on DOACs that had an excess ICH rate with thrombolysis,” Dr. Seiffge said,
He explained that receiving warfarin was at one time an absolute contraindication for thrombolysis, but after a 2014 study suggested that the risk was not increased for patients with an international normalized ratio below 117, this was downgraded to a relative contraindication.
“We think our study is comparable and should lead to a guideline change,” Dr. Seiffge commented.
“A relative contraindication allows clinicians the space to make a considered decision on an individual basis,” he added.
Dr. Seiffge said that at his hospital, local guidelines regarding this issue have already been changed on the basis of these data, and use of DOACs is now considered a relative contraindication.
“International guidelines can take years to update, so in the meantime, I think other centers will also go ahead with a more liberal approach. There are always some centers that are ahead of the guidelines,” he added.
Although the lower risk of sICH seen in patients who have recently used DOACs seems counterintuitive at first glance, there could be a pathophysiologic explanation for this finding, the authors suggest.
They point out that thrombin inhibition, either directly or via the coagulation cascade, might be protective against the occurrence of sICH.
“Anticoagulants may allow the clot to respond better to thrombolysis – the clot is not as solid and is easier to recanalize. This leads to smaller strokes and a lower bleeding risk. Thrombin generation is also a major driver for blood brain barrier breakdown. DOACs reduce thrombin generation, so reduce blood brain barrier breakdown and reduce bleeding,” Dr. Seiffge explained. “But these are hypotheses,” he added.
Study ‘meaningfully advances the field’
In an accompanying editorial, Eva A. Mistry, MBBS, University of Cincinnati, said the current study “meaningfully advances the field” and provides an estimation of safety of intravenous thrombolysis among patients who have taken DOACs within 48 hours of hospital admission.
She lists strengths of the study as inclusion of a large number of patients across several geographically diverse institutions with heterogeneous standard practices for thrombolysis with recent DOAC use and narrow confidence intervals regarding observed rates of sICH.
“Further, the upper bound of this confidence interval for the DOAC group is below 4%, which is a welcome result and provides supportive data for clinicians who already practice thrombolysis for patients with recent DOAC ingestion,” Dr. Mistry adds.
However, she points out several study limitations, which she says limit immediate, widespread clinical applicability.
These include use of a nonconcurrent control population, which included patients from centers that did not contribute to the DOAC group and the inclusion of Asian patients who likely received a lower thrombolytic dose.
Dr. Seiffge noted that the researchers did adjust for Asian patients but not for the thrombolytic dosage. “I personally do not think this affects the results, as Asian patients have a lower dosage because they have a higher bleeding risk. The lower bleeding risk with DOACs was seen in all continents.”
Dr. Mistry also suggests that the DOAC group itself is prone to selection bias from preferential thrombolysis of patients receiving DOAC who are at lower risk of sICH.
But Dr. Seiffge argued: “I think, actually, the opposite is true. The DOAC patients were older, had more severe comorbidities, and an increased bleeding risk.”
Dr. Mistry concluded, “Despite the limitations of the study design and enrolled population, these data may be used by clinicians to make individualized decisions regarding thrombolysis among patients with recent DOAC use. Importantly, this study lays the foundation for prospective, well-powered studies that definitively determine the safety of thrombolysis in this population.”
The study was supported by a grant from the Bangerter-Rhyner Foundation. Dr. Seiffge received grants from Bangerter Rhyner Foundation during the conduct of the study and personal fees from Bayer, Alexion, and VarmX outside the submitted work. Dr. Mistry receives grant funding from the National Institute of Neurological Disorders and Stroke and serves as a consultant for RAPID AI.
A version of this article first appeared on Medscape.com.
, a new study has found.
The study, the largest ever regarding the safety of thrombolysis in patients on DOACs, actually found a lower rate of sICH among patients taking DOACs than among those not taking anticoagulants.
“Thrombolysis is a backbone therapy in stroke, but the large population of patients who take DOACs are currently excluded from this treatment because DOAC use is a contraindication to treatment with thrombolysis. This is based on the presumption of an increased risk of sICH, but data to support or refute this presumption are lacking,” said senior author David J. Seiffge, MD, Bern University Hospital, Switzerland.
“Our results suggest that current guidelines need to be revised to remove the absolute contraindication of thrombolysis in patients on DOACs. The guidelines need to be more liberal on the use of thrombolysis in these patients,” he added.
“This study provides the basis for extending vital thrombolysis treatment to this substantial population of patients who take DOACs,” Dr. Seiffge said.
He estimates that 1 of every 6 stroke patients are taking a DOAC and that 1% to 2% of patients taking DOACs have a stroke each year. “As millions of patients are on DOACs, this is a large number of people who are not getting potentially life-saving thrombolysis therapy.”
Dr. Seiffge comments: “In our hospital we see at least one stroke patient on DOACs every day. It is a very frequent scenario. With this new data, we believe many of these patients could now benefit from thrombolysis without an increased bleeding risk.”
The study was published online in JAMA Neurology.
An international investigation
While thrombolysis is currently contraindicated for patients taking DOACs, some clinicians still administer thrombolysis to these patients. Different selection strategies are used, including the use of DOAC reversal agents prior to thrombolysis or the selection of patients with low anticoagulant activity, the authors noted.
The current study involved an international collaboration. The investigators compared the risk of sICH among patients who had recently taken DOACs and who underwent thrombolysis as treatment for acute ischemic stroke with the risk among control stroke patients who underwent thrombolysis but who had not been taking DOACs.
Potential contributing centers were identified by a systematic search of the literature based on published studies on the use of thrombolysis for patients who had recently taken DOACs or prospective stroke registries that may include patients who had recently taken DOACs.
The study included 832 patients from 64 centers worldwide who were confirmed to have taken a DOAC within 48 hours of receiving thrombolysis for acute ischemic stroke. The comparison group was made up of 32,375 patients who had experienced ischemic stroke that was treated with thrombolysis but who had received no prior anticoagulation therapy.
Compared with control patients, patients who had recently taken DOACs were older; the incidence of hypertension among them was higher; they had a higher degree of prestroke disability; they were less likely to be smokers; the time from symptom onset to treatment was longer; they had experienced more severe stroke; and they were more likely to have a large-vessel occlusion.
Of the patients taking DOACs, 30.3% received DOAC reversal prior to thrombolysis. For 27.0%, DOAC plasma levels were measured. The remainder were treated with thrombolysis without either of these selection methods.
Results showed that the unadjusted rate of sICH was 2.5% among patients taking DOACs, compared with 4.1% among control patients who were not taking anticoagulants.
After adjustment for stroke severity and other baseline sICH predictors, patients who had recently taken DOACs and who received thrombolysis had lower odds of developing sICH (adjusted odds ratio, 0.57; 95% confidence interval, 0.36-0.92; P = .02).
There was no difference between the selection strategies, and results were consistent in different sensitivity analyses.
The secondary outcome of any ICH occurred in 18.0% in patients taking DOACs, compared with 17.4% among control patients who used no anticoagulants. After adjustment, there was no difference in the odds for any ICH between the groups (aOR, 1.18; 95% CI, 0.95-1.45; P = .14).
The unadjusted rate of functional independence was 45% among patients taking DOACs, compared with 57% among control patients. After adjustment, patients who had recently taken DOACs and who underwent thrombolysis had numerically higher odds of being functionally independent than control patients, although this difference did not reach statistical significance (aOR, 1.13; 95% CI, 0.94-1.36; P = .20).
The association of DOAC therapy with lower odds of sICH remained when mechanical thrombectomy, large-vessel occlusion, or concomitant antiplatelet therapy was added to the model.
“This is by far the largest study to look at this issue of thrombolytic use in patients on DOACs, and we did not find any group on DOACs that had an excess ICH rate with thrombolysis,” Dr. Seiffge said,
He explained that receiving warfarin was at one time an absolute contraindication for thrombolysis, but after a 2014 study suggested that the risk was not increased for patients with an international normalized ratio below 117, this was downgraded to a relative contraindication.
“We think our study is comparable and should lead to a guideline change,” Dr. Seiffge commented.
“A relative contraindication allows clinicians the space to make a considered decision on an individual basis,” he added.
Dr. Seiffge said that at his hospital, local guidelines regarding this issue have already been changed on the basis of these data, and use of DOACs is now considered a relative contraindication.
“International guidelines can take years to update, so in the meantime, I think other centers will also go ahead with a more liberal approach. There are always some centers that are ahead of the guidelines,” he added.
Although the lower risk of sICH seen in patients who have recently used DOACs seems counterintuitive at first glance, there could be a pathophysiologic explanation for this finding, the authors suggest.
They point out that thrombin inhibition, either directly or via the coagulation cascade, might be protective against the occurrence of sICH.
“Anticoagulants may allow the clot to respond better to thrombolysis – the clot is not as solid and is easier to recanalize. This leads to smaller strokes and a lower bleeding risk. Thrombin generation is also a major driver for blood brain barrier breakdown. DOACs reduce thrombin generation, so reduce blood brain barrier breakdown and reduce bleeding,” Dr. Seiffge explained. “But these are hypotheses,” he added.
Study ‘meaningfully advances the field’
In an accompanying editorial, Eva A. Mistry, MBBS, University of Cincinnati, said the current study “meaningfully advances the field” and provides an estimation of safety of intravenous thrombolysis among patients who have taken DOACs within 48 hours of hospital admission.
She lists strengths of the study as inclusion of a large number of patients across several geographically diverse institutions with heterogeneous standard practices for thrombolysis with recent DOAC use and narrow confidence intervals regarding observed rates of sICH.
“Further, the upper bound of this confidence interval for the DOAC group is below 4%, which is a welcome result and provides supportive data for clinicians who already practice thrombolysis for patients with recent DOAC ingestion,” Dr. Mistry adds.
However, she points out several study limitations, which she says limit immediate, widespread clinical applicability.
These include use of a nonconcurrent control population, which included patients from centers that did not contribute to the DOAC group and the inclusion of Asian patients who likely received a lower thrombolytic dose.
Dr. Seiffge noted that the researchers did adjust for Asian patients but not for the thrombolytic dosage. “I personally do not think this affects the results, as Asian patients have a lower dosage because they have a higher bleeding risk. The lower bleeding risk with DOACs was seen in all continents.”
Dr. Mistry also suggests that the DOAC group itself is prone to selection bias from preferential thrombolysis of patients receiving DOAC who are at lower risk of sICH.
But Dr. Seiffge argued: “I think, actually, the opposite is true. The DOAC patients were older, had more severe comorbidities, and an increased bleeding risk.”
Dr. Mistry concluded, “Despite the limitations of the study design and enrolled population, these data may be used by clinicians to make individualized decisions regarding thrombolysis among patients with recent DOAC use. Importantly, this study lays the foundation for prospective, well-powered studies that definitively determine the safety of thrombolysis in this population.”
The study was supported by a grant from the Bangerter-Rhyner Foundation. Dr. Seiffge received grants from Bangerter Rhyner Foundation during the conduct of the study and personal fees from Bayer, Alexion, and VarmX outside the submitted work. Dr. Mistry receives grant funding from the National Institute of Neurological Disorders and Stroke and serves as a consultant for RAPID AI.
A version of this article first appeared on Medscape.com.
From JAMA Neurology
Why is a healthy diet so hard to maintain?
Does this surprise anyone?
Although first publicized in 1975, the diet really didn’t gain attention until the 1990s. But, since then, the evidence in its favor has steadily grown.
Granted, while it was codified into a diet then, the benefits of fruits and vegetables weren’t exactly a secret beforehand. I’m pretty sure all of us remember being told to eat our vegetables (often repeatedly) while growing up.
So it’s not like we, both medical and nonmedical people, should be surprised at the results.
Is it really going to change anyone’s dietary habits?
Of course it will! It’s the beginning of the new year, and this time people are actually going to stick with their resolutions! For the first time they understand that ... who am I kidding?
For some people (hopefully myself included) there will be success at eating better and taking care of themselves. For most it will be Groundhog Day, both literally and figuratively, when February comes around.
It makes me wonder why this is. We all know what’s good for us. The evidence to support the Mediterranean diet is solid. The foods on it are widely available, often at lower cost than the usual American protein-heavy and processed foods habits. They’re flexible, and, generally taste good.
Yet, for all the evidence behind it, most won’t stick with it. Too many years of habits. Too many stressful days at work that lower our willpower to stick with it. Too many convenient reasons to count.
The question really isn’t “what’s the best diet?” That’s been answered. Realistically I don’t see that changing anytime soon.
The real question is “how do I stick with it?”
And another 5, 10, or 20 years of annually trying to figure out what the best diet is won’t change that.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Does this surprise anyone?
Although first publicized in 1975, the diet really didn’t gain attention until the 1990s. But, since then, the evidence in its favor has steadily grown.
Granted, while it was codified into a diet then, the benefits of fruits and vegetables weren’t exactly a secret beforehand. I’m pretty sure all of us remember being told to eat our vegetables (often repeatedly) while growing up.
So it’s not like we, both medical and nonmedical people, should be surprised at the results.
Is it really going to change anyone’s dietary habits?
Of course it will! It’s the beginning of the new year, and this time people are actually going to stick with their resolutions! For the first time they understand that ... who am I kidding?
For some people (hopefully myself included) there will be success at eating better and taking care of themselves. For most it will be Groundhog Day, both literally and figuratively, when February comes around.
It makes me wonder why this is. We all know what’s good for us. The evidence to support the Mediterranean diet is solid. The foods on it are widely available, often at lower cost than the usual American protein-heavy and processed foods habits. They’re flexible, and, generally taste good.
Yet, for all the evidence behind it, most won’t stick with it. Too many years of habits. Too many stressful days at work that lower our willpower to stick with it. Too many convenient reasons to count.
The question really isn’t “what’s the best diet?” That’s been answered. Realistically I don’t see that changing anytime soon.
The real question is “how do I stick with it?”
And another 5, 10, or 20 years of annually trying to figure out what the best diet is won’t change that.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Does this surprise anyone?
Although first publicized in 1975, the diet really didn’t gain attention until the 1990s. But, since then, the evidence in its favor has steadily grown.
Granted, while it was codified into a diet then, the benefits of fruits and vegetables weren’t exactly a secret beforehand. I’m pretty sure all of us remember being told to eat our vegetables (often repeatedly) while growing up.
So it’s not like we, both medical and nonmedical people, should be surprised at the results.
Is it really going to change anyone’s dietary habits?
Of course it will! It’s the beginning of the new year, and this time people are actually going to stick with their resolutions! For the first time they understand that ... who am I kidding?
For some people (hopefully myself included) there will be success at eating better and taking care of themselves. For most it will be Groundhog Day, both literally and figuratively, when February comes around.
It makes me wonder why this is. We all know what’s good for us. The evidence to support the Mediterranean diet is solid. The foods on it are widely available, often at lower cost than the usual American protein-heavy and processed foods habits. They’re flexible, and, generally taste good.
Yet, for all the evidence behind it, most won’t stick with it. Too many years of habits. Too many stressful days at work that lower our willpower to stick with it. Too many convenient reasons to count.
The question really isn’t “what’s the best diet?” That’s been answered. Realistically I don’t see that changing anytime soon.
The real question is “how do I stick with it?”
And another 5, 10, or 20 years of annually trying to figure out what the best diet is won’t change that.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
New consensus on thyroid eye disease prompts some debate
A new consensus statement from the American Thyroid Association (ATA) and European Thyroid Association (ETA) offers recommendations for endocrinologists on the management of thyroid eye disease (TED), addressing key questions, including about important novel treatments, that transcend international borders.
The consensus statement is important as new therapies transform the treatment of TED that, notably, have even played a key role in simplifying the name of the disease, which has had numerous other, often confusing names over the years, ranging from thyrotropic exophthalmos to Graves ophthalmopathy, Terry F. Davies, MD, of the thyroid research unit, department of medicine, Icahn School of Medicine at Mount Sinai, New York, said in an editorial published along with the statement in Thyroid.
“The emergence of novel therapies has changed the entire discussion concerning TED and not just its name,” he wrote. “These are early and exciting days in the treatment of TED, which is likely to be a much more manageable disease in the years to come.”
However, Dr. Davies stressed to this news organization that there are still a lot of unanswered questions, particularly when it comes to newer therapies. For example, teprotumumab can cost up to $300,000 for one course of treatment for one patient, the consensus statement notes.
When to consult an ophthalmologist
Graves disease is the most common cause of hyperthyroidism and affects > 1% of the U.S. population. TED is the most common complication of Graves disease that occurs outside of the thyroid gland. TED causes a variety of eye-related signs and symptoms, which can be disfiguring and negatively affect quality of life, and in rare cases, threaten vision.
Key issues covered in the consensus statement include timely diagnosis of TED, assessment of disease activity and severity, initial care and referral for specialty care, and treatment recommendations for moderate to severe TED.
In terms of disease assessment, for instance, the statement authors noted the important distinction in TED “between the two interdependent components of inflammatory activity, manifested by pain, redness, and edema, and disease severity, including proptosis, lid malposition, exposure keratopathy, impaired ocular motility, and optic neuropathy.”
“The presence of multiple features of inflammation usually signifies active disease,” they explained.
For initial care, input from endocrinologists as well as ophthalmologists with experience in TED management is urged, and “an ophthalmologist should be consulted when the diagnosis of TED is uncertain, in cases of moderate to severe TED, and when surgical intervention needs to be considered.”
Furthermore, “urgent referral is required when sight-threatening TED is suspected or confirmed,” the authors noted.
Debate over some treatment recommendations
In terms of therapy, for initial care, “a single course of selenium selenite 100 mcg twice daily for 6 months may be considered for patients with mild, active TED, particularly in regions of selenium insufficiency,” the consensus statement recommends.
Intravenous glucocorticoid (IVGC) therapy is meanwhile recommended as a preferred treatment for active moderate to severe TED specifically when disease activity is the prominent feature in the absence of significant proptosis or diplopia.
For patients with active moderate to severe TED who are glucocorticoid-resistant, the authors noted that rituximab and tocilizumab may be considered and that teprotumumab has not been evaluated in this setting.
Teprotumumab, if available, is a preferred therapy for patients with active moderate to severe TED who have significant proptosis.
There is, however, some debate over the issue, editorial author Dr. Davies told this news organization.
“It is still argued over how bad the eyes need to be before recommending this new treatment,” he said. “I think the answer is in the proptosis – the amount of bulging present rather than just inflammation,” Dr. Davies said.
“There is also a real clinical problem in that we have no specific biomarker for the disease, however, high levels of TSH receptor antibody are often a good indicator of eye disease.”
The authors cautioned, however, that clinical trials with medical therapies have been limited by inclusion criteria and other factors, and biologics have meanwhile increased the cost of treatment “many-fold” compared with conventional agents.
Therefore, “clinicians should balance the demonstrated efficacy of recently introduced therapies [such as teprotumumab] against the absence of experience on sustained long-term efficacy, safety, and cost-effectiveness,” they noted.
Importantly, “one course consisting of eight infusions of teprotumumab has a retail cost of approximately $300,000, depending on patient weight, [which is] approximately 2,000 times that of IVGC,” they noted.
“The process involved in selecting therapy with these drugs and other drugs includes a consideration of both short- and long-term efficacy, adverse effects that are both known and unknown, the likelihood of disease aggravation or relapse after a previously beneficial response, and the relative cost and availability,” said Henry B. Burch, MD, who is at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, in Bethesda, Md., and is on the consensus statement task force.
To help with those decisions, the consensus statement provides comprehensive tables that compare drug efficacy for key outcomes including inflammation, proptosis, diplopia, and quality of life, and importantly, comparisons also of drug costs and potential adverse effects for each of the current TED therapies.
Consensus statement not a guideline
The groups noted that the consensus statement is not meant to be a clinical practice guideline and was not written to “establish a standard of care, replace sound clinical judgment, or capture all nuances likely to be present in any particular patient,” and “specific outcomes are not guaranteed.”
What the statement is intended for is to “provide a concise and timely appraisal of a rapidly changing therapeutic arena” for practicing endocrinologists, they explained.
Overall, the authors recommend an individualized management approach, based on factors ranging from disease severity, duration, its impact on daily living, patient age, comorbidities, and importantly, the costs of therapies.
Ultimately, patient satisfaction is essential in TED management, Dr. Burch added.
“Consideration of the impact of TED on patient’s satisfaction with their appearance and visual functioning is a key component in management decisions concerning TED.”A version of this article first appeared on Medscape.com.
A new consensus statement from the American Thyroid Association (ATA) and European Thyroid Association (ETA) offers recommendations for endocrinologists on the management of thyroid eye disease (TED), addressing key questions, including about important novel treatments, that transcend international borders.
The consensus statement is important as new therapies transform the treatment of TED that, notably, have even played a key role in simplifying the name of the disease, which has had numerous other, often confusing names over the years, ranging from thyrotropic exophthalmos to Graves ophthalmopathy, Terry F. Davies, MD, of the thyroid research unit, department of medicine, Icahn School of Medicine at Mount Sinai, New York, said in an editorial published along with the statement in Thyroid.
“The emergence of novel therapies has changed the entire discussion concerning TED and not just its name,” he wrote. “These are early and exciting days in the treatment of TED, which is likely to be a much more manageable disease in the years to come.”
However, Dr. Davies stressed to this news organization that there are still a lot of unanswered questions, particularly when it comes to newer therapies. For example, teprotumumab can cost up to $300,000 for one course of treatment for one patient, the consensus statement notes.
When to consult an ophthalmologist
Graves disease is the most common cause of hyperthyroidism and affects > 1% of the U.S. population. TED is the most common complication of Graves disease that occurs outside of the thyroid gland. TED causes a variety of eye-related signs and symptoms, which can be disfiguring and negatively affect quality of life, and in rare cases, threaten vision.
Key issues covered in the consensus statement include timely diagnosis of TED, assessment of disease activity and severity, initial care and referral for specialty care, and treatment recommendations for moderate to severe TED.
In terms of disease assessment, for instance, the statement authors noted the important distinction in TED “between the two interdependent components of inflammatory activity, manifested by pain, redness, and edema, and disease severity, including proptosis, lid malposition, exposure keratopathy, impaired ocular motility, and optic neuropathy.”
“The presence of multiple features of inflammation usually signifies active disease,” they explained.
For initial care, input from endocrinologists as well as ophthalmologists with experience in TED management is urged, and “an ophthalmologist should be consulted when the diagnosis of TED is uncertain, in cases of moderate to severe TED, and when surgical intervention needs to be considered.”
Furthermore, “urgent referral is required when sight-threatening TED is suspected or confirmed,” the authors noted.
Debate over some treatment recommendations
In terms of therapy, for initial care, “a single course of selenium selenite 100 mcg twice daily for 6 months may be considered for patients with mild, active TED, particularly in regions of selenium insufficiency,” the consensus statement recommends.
Intravenous glucocorticoid (IVGC) therapy is meanwhile recommended as a preferred treatment for active moderate to severe TED specifically when disease activity is the prominent feature in the absence of significant proptosis or diplopia.
For patients with active moderate to severe TED who are glucocorticoid-resistant, the authors noted that rituximab and tocilizumab may be considered and that teprotumumab has not been evaluated in this setting.
Teprotumumab, if available, is a preferred therapy for patients with active moderate to severe TED who have significant proptosis.
There is, however, some debate over the issue, editorial author Dr. Davies told this news organization.
“It is still argued over how bad the eyes need to be before recommending this new treatment,” he said. “I think the answer is in the proptosis – the amount of bulging present rather than just inflammation,” Dr. Davies said.
“There is also a real clinical problem in that we have no specific biomarker for the disease, however, high levels of TSH receptor antibody are often a good indicator of eye disease.”
The authors cautioned, however, that clinical trials with medical therapies have been limited by inclusion criteria and other factors, and biologics have meanwhile increased the cost of treatment “many-fold” compared with conventional agents.
Therefore, “clinicians should balance the demonstrated efficacy of recently introduced therapies [such as teprotumumab] against the absence of experience on sustained long-term efficacy, safety, and cost-effectiveness,” they noted.
Importantly, “one course consisting of eight infusions of teprotumumab has a retail cost of approximately $300,000, depending on patient weight, [which is] approximately 2,000 times that of IVGC,” they noted.
“The process involved in selecting therapy with these drugs and other drugs includes a consideration of both short- and long-term efficacy, adverse effects that are both known and unknown, the likelihood of disease aggravation or relapse after a previously beneficial response, and the relative cost and availability,” said Henry B. Burch, MD, who is at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, in Bethesda, Md., and is on the consensus statement task force.
To help with those decisions, the consensus statement provides comprehensive tables that compare drug efficacy for key outcomes including inflammation, proptosis, diplopia, and quality of life, and importantly, comparisons also of drug costs and potential adverse effects for each of the current TED therapies.
Consensus statement not a guideline
The groups noted that the consensus statement is not meant to be a clinical practice guideline and was not written to “establish a standard of care, replace sound clinical judgment, or capture all nuances likely to be present in any particular patient,” and “specific outcomes are not guaranteed.”
What the statement is intended for is to “provide a concise and timely appraisal of a rapidly changing therapeutic arena” for practicing endocrinologists, they explained.
Overall, the authors recommend an individualized management approach, based on factors ranging from disease severity, duration, its impact on daily living, patient age, comorbidities, and importantly, the costs of therapies.
Ultimately, patient satisfaction is essential in TED management, Dr. Burch added.
“Consideration of the impact of TED on patient’s satisfaction with their appearance and visual functioning is a key component in management decisions concerning TED.”A version of this article first appeared on Medscape.com.
A new consensus statement from the American Thyroid Association (ATA) and European Thyroid Association (ETA) offers recommendations for endocrinologists on the management of thyroid eye disease (TED), addressing key questions, including about important novel treatments, that transcend international borders.
The consensus statement is important as new therapies transform the treatment of TED that, notably, have even played a key role in simplifying the name of the disease, which has had numerous other, often confusing names over the years, ranging from thyrotropic exophthalmos to Graves ophthalmopathy, Terry F. Davies, MD, of the thyroid research unit, department of medicine, Icahn School of Medicine at Mount Sinai, New York, said in an editorial published along with the statement in Thyroid.
“The emergence of novel therapies has changed the entire discussion concerning TED and not just its name,” he wrote. “These are early and exciting days in the treatment of TED, which is likely to be a much more manageable disease in the years to come.”
However, Dr. Davies stressed to this news organization that there are still a lot of unanswered questions, particularly when it comes to newer therapies. For example, teprotumumab can cost up to $300,000 for one course of treatment for one patient, the consensus statement notes.
When to consult an ophthalmologist
Graves disease is the most common cause of hyperthyroidism and affects > 1% of the U.S. population. TED is the most common complication of Graves disease that occurs outside of the thyroid gland. TED causes a variety of eye-related signs and symptoms, which can be disfiguring and negatively affect quality of life, and in rare cases, threaten vision.
Key issues covered in the consensus statement include timely diagnosis of TED, assessment of disease activity and severity, initial care and referral for specialty care, and treatment recommendations for moderate to severe TED.
In terms of disease assessment, for instance, the statement authors noted the important distinction in TED “between the two interdependent components of inflammatory activity, manifested by pain, redness, and edema, and disease severity, including proptosis, lid malposition, exposure keratopathy, impaired ocular motility, and optic neuropathy.”
“The presence of multiple features of inflammation usually signifies active disease,” they explained.
For initial care, input from endocrinologists as well as ophthalmologists with experience in TED management is urged, and “an ophthalmologist should be consulted when the diagnosis of TED is uncertain, in cases of moderate to severe TED, and when surgical intervention needs to be considered.”
Furthermore, “urgent referral is required when sight-threatening TED is suspected or confirmed,” the authors noted.
Debate over some treatment recommendations
In terms of therapy, for initial care, “a single course of selenium selenite 100 mcg twice daily for 6 months may be considered for patients with mild, active TED, particularly in regions of selenium insufficiency,” the consensus statement recommends.
Intravenous glucocorticoid (IVGC) therapy is meanwhile recommended as a preferred treatment for active moderate to severe TED specifically when disease activity is the prominent feature in the absence of significant proptosis or diplopia.
For patients with active moderate to severe TED who are glucocorticoid-resistant, the authors noted that rituximab and tocilizumab may be considered and that teprotumumab has not been evaluated in this setting.
Teprotumumab, if available, is a preferred therapy for patients with active moderate to severe TED who have significant proptosis.
There is, however, some debate over the issue, editorial author Dr. Davies told this news organization.
“It is still argued over how bad the eyes need to be before recommending this new treatment,” he said. “I think the answer is in the proptosis – the amount of bulging present rather than just inflammation,” Dr. Davies said.
“There is also a real clinical problem in that we have no specific biomarker for the disease, however, high levels of TSH receptor antibody are often a good indicator of eye disease.”
The authors cautioned, however, that clinical trials with medical therapies have been limited by inclusion criteria and other factors, and biologics have meanwhile increased the cost of treatment “many-fold” compared with conventional agents.
Therefore, “clinicians should balance the demonstrated efficacy of recently introduced therapies [such as teprotumumab] against the absence of experience on sustained long-term efficacy, safety, and cost-effectiveness,” they noted.
Importantly, “one course consisting of eight infusions of teprotumumab has a retail cost of approximately $300,000, depending on patient weight, [which is] approximately 2,000 times that of IVGC,” they noted.
“The process involved in selecting therapy with these drugs and other drugs includes a consideration of both short- and long-term efficacy, adverse effects that are both known and unknown, the likelihood of disease aggravation or relapse after a previously beneficial response, and the relative cost and availability,” said Henry B. Burch, MD, who is at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, in Bethesda, Md., and is on the consensus statement task force.
To help with those decisions, the consensus statement provides comprehensive tables that compare drug efficacy for key outcomes including inflammation, proptosis, diplopia, and quality of life, and importantly, comparisons also of drug costs and potential adverse effects for each of the current TED therapies.
Consensus statement not a guideline
The groups noted that the consensus statement is not meant to be a clinical practice guideline and was not written to “establish a standard of care, replace sound clinical judgment, or capture all nuances likely to be present in any particular patient,” and “specific outcomes are not guaranteed.”
What the statement is intended for is to “provide a concise and timely appraisal of a rapidly changing therapeutic arena” for practicing endocrinologists, they explained.
Overall, the authors recommend an individualized management approach, based on factors ranging from disease severity, duration, its impact on daily living, patient age, comorbidities, and importantly, the costs of therapies.
Ultimately, patient satisfaction is essential in TED management, Dr. Burch added.
“Consideration of the impact of TED on patient’s satisfaction with their appearance and visual functioning is a key component in management decisions concerning TED.”A version of this article first appeared on Medscape.com.