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Virtual yoga program appears to improve IBS symptoms, fatigue, stress
Participants reported a decrease in IBS-related symptoms and improvements in quality of life, fatigue, and perceived stress.
“IBS affects upwards of 15%-20% of the North American population, and despite our advances in the area, we have very limited options to offer our patients,” Maitreyi Raman, MD, an associate professor of medicine at the University of Calgary (Alta.), said in an interview.
“Often, we are focused on treating symptoms but not addressing the underlying cause,” said Dr. Raman, who is director of Alberta’s Collaboration of Excellence for Nutrition in Digestive Diseases. “With advances around the gut microbiome and the evolving science on the brain-gut axis, mind-body interventions could offer a therapeutic option that patients can use to improve the overall course of their disease.”
The study was published online in the American Journal of Gastroenterology.
Online yoga program vs. IBS advice only
IBS often involves alterations of the gut-brain axis and can be affected by psychological or physiological stress, the study authors write. Previous studies have found that in-person yoga programs can manage IBS symptoms and improve physiological, psychological, and emotional health.
During the COVID-19 pandemic, yoga programs had to switch to a virtual format – a delivery method that could remain relevant due to limited health care resources. However, the efficacy, feasibility, and safety of virtual yoga for people with IBS were unknown.
Dr. Raman and colleagues conducted a randomized, two-group, controlled clinical trial at the University of Calgary (Alta.) between March 2021 and December 2022. The 79 participants weren’t blinded to the trial arms – an online yoga program or an advice-only control group.
The eligible participants had a diagnosis of IBS, scored at least 75 out of 500 points on the IBS Symptoms Severity Scale (IBS-SSS) for mild IBS, and were on stable doses of medications for IBS. They were instructed to continue with their current therapies during the study but didn’t start new medications or make major changes to their diet or physical patterns.
The yoga program was based on Upa Yoga, a subtype of Hatha Yoga developed by the Isha Foundation of Inner Sciences. The program was delivered by a certified yoga facilitator from the Isha Foundation and included directional movements, neck rotations, breathing practices, breath watching, and mantra meditation with aum/om chanting.
The online classes of three to seven participants were delivered in 60-minute sessions for 8 weeks. The participants were also asked to practice at home daily with the support of yoga videos.
The advice-only control group included a 10-minute video with general education on IBS, the mind-gut connection in IBS, and the role of mind-body therapies in managing IBS. The participants received a list of IBS-related resources from the Canadian Digestive Health Foundation, a link to an IBS patient support group, and information about physical activity guidelines from the World Health Organization.
The research team looked for a primary endpoint of at least a 50-point reduction on the IBS-SSS, which is considered clinically meaningful.
They also measured for secondary outcomes, such as quality of life, anxiety, depression, perceived stress, COVID-19–related stress, fatigue, somatic symptoms, self-compassion, and intention to practice yoga.
Among the 79 participants, 38 were randomized to the yoga program and 41 were randomized to the advice-only control group. The average age was 45 years. Most (92%) were women, and 81% were White. The average IBS duration since diagnosis was 11.5 years.
The overall average IBS-SSS was moderate, at 245.3, at the beginning of the program, and dropped to 207.9 at week 8. The score decreased from 255.2 to 200.5 in the yoga group and from 236.1 to 213.5 in the control group. The difference between the groups was 32 points, which wasn’t statistically significant, though symptom improvement began after 4 weeks in the yoga group.
In the yoga group, 14 participants (37%) met the target decrease of 50 points or more, compared with eight participants (20%) in the control group. These 22 “responders” reported improvements in IBS symptoms, quality of life, perceived stress, and COVID-19–related stress.
Specifically, among the 14 responders in the yoga group, there were significant improvements in IBS symptoms, quality of life, fatigue, somatic symptoms, self-compassion, and COVID-19–related stress. In the control group, there were significant improvements in IBS symptoms and COVID-19–related stress.
Using an intent-to-treat analysis, the research team found that the yoga group had improved quality of life, fatigue, and perceived stress. In the control group, improvements were seen only in COVID-19–related stress.
No significant improvements were found in anxiety or depression between the groups, although the changes in depression scores were in favor of the yoga group. The intention to practice yoga dropped in both groups during the study period, but it wasn’t associated with the actual yoga practice minutes or change in IBS-SSS scores.
“We saw a surprising improvement in quality of life,” Dr. Raman said. “Although we talk about quality of life as an important endpoint, it can be hard to show in studies, so that was a nice finding to demonstrate in this study.”
The yoga intervention was feasible in terms of adherence (79%), attrition rate (20%), and high program satisfaction, the researchers write. Safety was demonstrated by the absence of any adverse events.
Future program considerations
Dr. Raman and colleagues are interested in understanding the mechanisms that underlie the efficacy of mind-body interventions. They also plan to test the virtual yoga program in a mobile app, called LyfeMD, which is intended to support patients with digestive diseases through evidence-based dietary programs and mind-body interventions, such as guided meditation, breathing exercises, and cognitive behavioral therapy.
“We know that patients are looking for all possible resources,” Dr. Raman said. “Our next goal is to better understand how an app-based intervention can be effective, even without a live instructor.”
Future studies should also consider clinicians’ perspectives, she noted. In previous studies, Dr. Raman and colleagues have found that physicians are open to recommending yoga as a therapeutic option for patients, but some are unsure how to prescribe a recommended dose, frequency, or type of yoga.
“When treating patients with IBS, it is important to think broadly and creatively about all our treatment options,” said Elyse Thakur, PhD, a clinical health psychologist at Atrium Health Gastroenterology and Hepatology, Charlotte, N.C.
Dr. Thakur, who wasn’t involved with this study, specializes in gastrointestinal health psychology. She and colleagues use numerous complementary and alternative medicine options with patients.
“We have to remember that people may respond differently to available treatment options,” she said. “It is imperative to understand the evidence so we can have productive conversations with our patients about the pros and cons and the potential benefits and limitations.”
The study did not receive a specific grant from a funding agency. The authors and Dr. Thakur declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Participants reported a decrease in IBS-related symptoms and improvements in quality of life, fatigue, and perceived stress.
“IBS affects upwards of 15%-20% of the North American population, and despite our advances in the area, we have very limited options to offer our patients,” Maitreyi Raman, MD, an associate professor of medicine at the University of Calgary (Alta.), said in an interview.
“Often, we are focused on treating symptoms but not addressing the underlying cause,” said Dr. Raman, who is director of Alberta’s Collaboration of Excellence for Nutrition in Digestive Diseases. “With advances around the gut microbiome and the evolving science on the brain-gut axis, mind-body interventions could offer a therapeutic option that patients can use to improve the overall course of their disease.”
The study was published online in the American Journal of Gastroenterology.
Online yoga program vs. IBS advice only
IBS often involves alterations of the gut-brain axis and can be affected by psychological or physiological stress, the study authors write. Previous studies have found that in-person yoga programs can manage IBS symptoms and improve physiological, psychological, and emotional health.
During the COVID-19 pandemic, yoga programs had to switch to a virtual format – a delivery method that could remain relevant due to limited health care resources. However, the efficacy, feasibility, and safety of virtual yoga for people with IBS were unknown.
Dr. Raman and colleagues conducted a randomized, two-group, controlled clinical trial at the University of Calgary (Alta.) between March 2021 and December 2022. The 79 participants weren’t blinded to the trial arms – an online yoga program or an advice-only control group.
The eligible participants had a diagnosis of IBS, scored at least 75 out of 500 points on the IBS Symptoms Severity Scale (IBS-SSS) for mild IBS, and were on stable doses of medications for IBS. They were instructed to continue with their current therapies during the study but didn’t start new medications or make major changes to their diet or physical patterns.
The yoga program was based on Upa Yoga, a subtype of Hatha Yoga developed by the Isha Foundation of Inner Sciences. The program was delivered by a certified yoga facilitator from the Isha Foundation and included directional movements, neck rotations, breathing practices, breath watching, and mantra meditation with aum/om chanting.
The online classes of three to seven participants were delivered in 60-minute sessions for 8 weeks. The participants were also asked to practice at home daily with the support of yoga videos.
The advice-only control group included a 10-minute video with general education on IBS, the mind-gut connection in IBS, and the role of mind-body therapies in managing IBS. The participants received a list of IBS-related resources from the Canadian Digestive Health Foundation, a link to an IBS patient support group, and information about physical activity guidelines from the World Health Organization.
The research team looked for a primary endpoint of at least a 50-point reduction on the IBS-SSS, which is considered clinically meaningful.
They also measured for secondary outcomes, such as quality of life, anxiety, depression, perceived stress, COVID-19–related stress, fatigue, somatic symptoms, self-compassion, and intention to practice yoga.
Among the 79 participants, 38 were randomized to the yoga program and 41 were randomized to the advice-only control group. The average age was 45 years. Most (92%) were women, and 81% were White. The average IBS duration since diagnosis was 11.5 years.
The overall average IBS-SSS was moderate, at 245.3, at the beginning of the program, and dropped to 207.9 at week 8. The score decreased from 255.2 to 200.5 in the yoga group and from 236.1 to 213.5 in the control group. The difference between the groups was 32 points, which wasn’t statistically significant, though symptom improvement began after 4 weeks in the yoga group.
In the yoga group, 14 participants (37%) met the target decrease of 50 points or more, compared with eight participants (20%) in the control group. These 22 “responders” reported improvements in IBS symptoms, quality of life, perceived stress, and COVID-19–related stress.
Specifically, among the 14 responders in the yoga group, there were significant improvements in IBS symptoms, quality of life, fatigue, somatic symptoms, self-compassion, and COVID-19–related stress. In the control group, there were significant improvements in IBS symptoms and COVID-19–related stress.
Using an intent-to-treat analysis, the research team found that the yoga group had improved quality of life, fatigue, and perceived stress. In the control group, improvements were seen only in COVID-19–related stress.
No significant improvements were found in anxiety or depression between the groups, although the changes in depression scores were in favor of the yoga group. The intention to practice yoga dropped in both groups during the study period, but it wasn’t associated with the actual yoga practice minutes or change in IBS-SSS scores.
“We saw a surprising improvement in quality of life,” Dr. Raman said. “Although we talk about quality of life as an important endpoint, it can be hard to show in studies, so that was a nice finding to demonstrate in this study.”
The yoga intervention was feasible in terms of adherence (79%), attrition rate (20%), and high program satisfaction, the researchers write. Safety was demonstrated by the absence of any adverse events.
Future program considerations
Dr. Raman and colleagues are interested in understanding the mechanisms that underlie the efficacy of mind-body interventions. They also plan to test the virtual yoga program in a mobile app, called LyfeMD, which is intended to support patients with digestive diseases through evidence-based dietary programs and mind-body interventions, such as guided meditation, breathing exercises, and cognitive behavioral therapy.
“We know that patients are looking for all possible resources,” Dr. Raman said. “Our next goal is to better understand how an app-based intervention can be effective, even without a live instructor.”
Future studies should also consider clinicians’ perspectives, she noted. In previous studies, Dr. Raman and colleagues have found that physicians are open to recommending yoga as a therapeutic option for patients, but some are unsure how to prescribe a recommended dose, frequency, or type of yoga.
“When treating patients with IBS, it is important to think broadly and creatively about all our treatment options,” said Elyse Thakur, PhD, a clinical health psychologist at Atrium Health Gastroenterology and Hepatology, Charlotte, N.C.
Dr. Thakur, who wasn’t involved with this study, specializes in gastrointestinal health psychology. She and colleagues use numerous complementary and alternative medicine options with patients.
“We have to remember that people may respond differently to available treatment options,” she said. “It is imperative to understand the evidence so we can have productive conversations with our patients about the pros and cons and the potential benefits and limitations.”
The study did not receive a specific grant from a funding agency. The authors and Dr. Thakur declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Participants reported a decrease in IBS-related symptoms and improvements in quality of life, fatigue, and perceived stress.
“IBS affects upwards of 15%-20% of the North American population, and despite our advances in the area, we have very limited options to offer our patients,” Maitreyi Raman, MD, an associate professor of medicine at the University of Calgary (Alta.), said in an interview.
“Often, we are focused on treating symptoms but not addressing the underlying cause,” said Dr. Raman, who is director of Alberta’s Collaboration of Excellence for Nutrition in Digestive Diseases. “With advances around the gut microbiome and the evolving science on the brain-gut axis, mind-body interventions could offer a therapeutic option that patients can use to improve the overall course of their disease.”
The study was published online in the American Journal of Gastroenterology.
Online yoga program vs. IBS advice only
IBS often involves alterations of the gut-brain axis and can be affected by psychological or physiological stress, the study authors write. Previous studies have found that in-person yoga programs can manage IBS symptoms and improve physiological, psychological, and emotional health.
During the COVID-19 pandemic, yoga programs had to switch to a virtual format – a delivery method that could remain relevant due to limited health care resources. However, the efficacy, feasibility, and safety of virtual yoga for people with IBS were unknown.
Dr. Raman and colleagues conducted a randomized, two-group, controlled clinical trial at the University of Calgary (Alta.) between March 2021 and December 2022. The 79 participants weren’t blinded to the trial arms – an online yoga program or an advice-only control group.
The eligible participants had a diagnosis of IBS, scored at least 75 out of 500 points on the IBS Symptoms Severity Scale (IBS-SSS) for mild IBS, and were on stable doses of medications for IBS. They were instructed to continue with their current therapies during the study but didn’t start new medications or make major changes to their diet or physical patterns.
The yoga program was based on Upa Yoga, a subtype of Hatha Yoga developed by the Isha Foundation of Inner Sciences. The program was delivered by a certified yoga facilitator from the Isha Foundation and included directional movements, neck rotations, breathing practices, breath watching, and mantra meditation with aum/om chanting.
The online classes of three to seven participants were delivered in 60-minute sessions for 8 weeks. The participants were also asked to practice at home daily with the support of yoga videos.
The advice-only control group included a 10-minute video with general education on IBS, the mind-gut connection in IBS, and the role of mind-body therapies in managing IBS. The participants received a list of IBS-related resources from the Canadian Digestive Health Foundation, a link to an IBS patient support group, and information about physical activity guidelines from the World Health Organization.
The research team looked for a primary endpoint of at least a 50-point reduction on the IBS-SSS, which is considered clinically meaningful.
They also measured for secondary outcomes, such as quality of life, anxiety, depression, perceived stress, COVID-19–related stress, fatigue, somatic symptoms, self-compassion, and intention to practice yoga.
Among the 79 participants, 38 were randomized to the yoga program and 41 were randomized to the advice-only control group. The average age was 45 years. Most (92%) were women, and 81% were White. The average IBS duration since diagnosis was 11.5 years.
The overall average IBS-SSS was moderate, at 245.3, at the beginning of the program, and dropped to 207.9 at week 8. The score decreased from 255.2 to 200.5 in the yoga group and from 236.1 to 213.5 in the control group. The difference between the groups was 32 points, which wasn’t statistically significant, though symptom improvement began after 4 weeks in the yoga group.
In the yoga group, 14 participants (37%) met the target decrease of 50 points or more, compared with eight participants (20%) in the control group. These 22 “responders” reported improvements in IBS symptoms, quality of life, perceived stress, and COVID-19–related stress.
Specifically, among the 14 responders in the yoga group, there were significant improvements in IBS symptoms, quality of life, fatigue, somatic symptoms, self-compassion, and COVID-19–related stress. In the control group, there were significant improvements in IBS symptoms and COVID-19–related stress.
Using an intent-to-treat analysis, the research team found that the yoga group had improved quality of life, fatigue, and perceived stress. In the control group, improvements were seen only in COVID-19–related stress.
No significant improvements were found in anxiety or depression between the groups, although the changes in depression scores were in favor of the yoga group. The intention to practice yoga dropped in both groups during the study period, but it wasn’t associated with the actual yoga practice minutes or change in IBS-SSS scores.
“We saw a surprising improvement in quality of life,” Dr. Raman said. “Although we talk about quality of life as an important endpoint, it can be hard to show in studies, so that was a nice finding to demonstrate in this study.”
The yoga intervention was feasible in terms of adherence (79%), attrition rate (20%), and high program satisfaction, the researchers write. Safety was demonstrated by the absence of any adverse events.
Future program considerations
Dr. Raman and colleagues are interested in understanding the mechanisms that underlie the efficacy of mind-body interventions. They also plan to test the virtual yoga program in a mobile app, called LyfeMD, which is intended to support patients with digestive diseases through evidence-based dietary programs and mind-body interventions, such as guided meditation, breathing exercises, and cognitive behavioral therapy.
“We know that patients are looking for all possible resources,” Dr. Raman said. “Our next goal is to better understand how an app-based intervention can be effective, even without a live instructor.”
Future studies should also consider clinicians’ perspectives, she noted. In previous studies, Dr. Raman and colleagues have found that physicians are open to recommending yoga as a therapeutic option for patients, but some are unsure how to prescribe a recommended dose, frequency, or type of yoga.
“When treating patients with IBS, it is important to think broadly and creatively about all our treatment options,” said Elyse Thakur, PhD, a clinical health psychologist at Atrium Health Gastroenterology and Hepatology, Charlotte, N.C.
Dr. Thakur, who wasn’t involved with this study, specializes in gastrointestinal health psychology. She and colleagues use numerous complementary and alternative medicine options with patients.
“We have to remember that people may respond differently to available treatment options,” she said. “It is imperative to understand the evidence so we can have productive conversations with our patients about the pros and cons and the potential benefits and limitations.”
The study did not receive a specific grant from a funding agency. The authors and Dr. Thakur declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Transplant provides no clear survival benefit in real-world MCL study
In younger patients with mantle cell lymphoma treated in U.S. community oncology settings in recent years, use of autologous transplant was not associated with improved survival, results of a large observational study show.
Autologous stem-cell transplant (ASCT) use was not linked overall survival (OS), according to the authors of the retrospective analysis of patients diagnosed with mantle cell lymphoma (MCL) between 2011 and 2021.
This lack of a clear survival benefit with use of ASCT is an “apparent contradiction” with prospective data from earlier clinical trials, authors wrote in the Journal of Clinical Oncology
However, they added, the finding is consistent with several recent registry analyses that also do not support a link between ASCT and overall survival in patients with MCL.
Although these findings are limited by the retrospective nature of the study, the results at least suggest that it is ethical to do research that doesn’t involve ASCT, study author Peter Martin, MD, said in an interview.
Furthermore, emerging data from the randomized TRIANGLE study from the European MCL Network suggest the potential for ASCT to be replaced by maintenance therapy with the Bruton's tyrosine kinase inhibitor ibrutinib, according to Dr. Martin, associate professor with Weill Cornell Medicine, New York.
“There are probably a lot of questions that will come up there, but essentially the barriers to research that do not include ASCT have been moved away, and we can go ahead and study non-ASCT (approaches) in younger patients,” Dr. Martin said.
No clear OS benefit
In current guidelines, recommended initial therapy for MCL patients younger than 65 years includes use of high-dose cytarabine-containing chemoimmunotherapy induction, followed by ASCT as consolidation, and then rituximab maintenance, Dr. Martin and coauthors say in their report.
Their primary analysis was based on the Flatiron Health database, which is derived from electronic medical records, mostly in U.S. community oncology practices, according to the report.
The researchers identified 1,274 patients under the age of 65 with a record of first-line treatment for MCL, and of those, 962 (or 76%) were considered eligible for ASCT.
Among ASCT-eligible patients, there was no significant association between receipt of ASCT and OS, with a hazard ratio of 0.86 (95% confidence interval, 0.63-1.18). The 3-year OS was 88% for patients receiving ASCT and similarly, 84% for those who did not, according to authors.
Likewise, there was no association between ASCT and real-world time to next treatment, an endpoint defined as time from start of first-line therapy to subsequent treatment or death, the report says.
Findings in perspective
The lack of clear survival benefit with ASCT in this and other recent observational studies may be explained in part by improvements in induction regimens, according to Timothy Fenske, MD, professor in the department of medicine at the Medical College of Wisconsin, Milwaukee.
“As our induction regimens have improved, it is very possible that the benefit for autologous transplantation will become less apparent,” Dr. Fenske said in an interview.
The discussion over ASCT in MCL is expected to evolve further in light of findings from TRIANGLE and EA4151, a randomized phase 3 trial of rituximab with or without ASCT specifically in patients with minimal residual disease (MRD)–negative MCL in first complete remission.
“If that study shows that the MRD-negative patients do not have much benefit from autologous transplantation,” Dr. Fenske said, “I think these studies will all be giving the same message – that autologous transplantation was beneficial back when induction regimens were poor (for example, CHOP without rituximab), but will have much less benefit in patients receiving modern inductions, which by and large will get more patients to be MRD negative.”
However, subgroup analyses of those TRIANGLE will be important, he added, since some patients may still benefit from ASCT, such as younger patients who remain MRD positive, or who have certain other high-risk molecular features.
Dr. Martin reported consulting or advisory roles with Janssen, BeiGene, Karyopharm Therapeutics, Kite/Gilead, Verastem, ADC Therapeutics, Bristol Myers Squibb/Celgene, Epizyme, Merck, MorphoSys, and Takeda. He reported institutional research funding from Karyopharm Therapeutics.
In younger patients with mantle cell lymphoma treated in U.S. community oncology settings in recent years, use of autologous transplant was not associated with improved survival, results of a large observational study show.
Autologous stem-cell transplant (ASCT) use was not linked overall survival (OS), according to the authors of the retrospective analysis of patients diagnosed with mantle cell lymphoma (MCL) between 2011 and 2021.
This lack of a clear survival benefit with use of ASCT is an “apparent contradiction” with prospective data from earlier clinical trials, authors wrote in the Journal of Clinical Oncology
However, they added, the finding is consistent with several recent registry analyses that also do not support a link between ASCT and overall survival in patients with MCL.
Although these findings are limited by the retrospective nature of the study, the results at least suggest that it is ethical to do research that doesn’t involve ASCT, study author Peter Martin, MD, said in an interview.
Furthermore, emerging data from the randomized TRIANGLE study from the European MCL Network suggest the potential for ASCT to be replaced by maintenance therapy with the Bruton's tyrosine kinase inhibitor ibrutinib, according to Dr. Martin, associate professor with Weill Cornell Medicine, New York.
“There are probably a lot of questions that will come up there, but essentially the barriers to research that do not include ASCT have been moved away, and we can go ahead and study non-ASCT (approaches) in younger patients,” Dr. Martin said.
No clear OS benefit
In current guidelines, recommended initial therapy for MCL patients younger than 65 years includes use of high-dose cytarabine-containing chemoimmunotherapy induction, followed by ASCT as consolidation, and then rituximab maintenance, Dr. Martin and coauthors say in their report.
Their primary analysis was based on the Flatiron Health database, which is derived from electronic medical records, mostly in U.S. community oncology practices, according to the report.
The researchers identified 1,274 patients under the age of 65 with a record of first-line treatment for MCL, and of those, 962 (or 76%) were considered eligible for ASCT.
Among ASCT-eligible patients, there was no significant association between receipt of ASCT and OS, with a hazard ratio of 0.86 (95% confidence interval, 0.63-1.18). The 3-year OS was 88% for patients receiving ASCT and similarly, 84% for those who did not, according to authors.
Likewise, there was no association between ASCT and real-world time to next treatment, an endpoint defined as time from start of first-line therapy to subsequent treatment or death, the report says.
Findings in perspective
The lack of clear survival benefit with ASCT in this and other recent observational studies may be explained in part by improvements in induction regimens, according to Timothy Fenske, MD, professor in the department of medicine at the Medical College of Wisconsin, Milwaukee.
“As our induction regimens have improved, it is very possible that the benefit for autologous transplantation will become less apparent,” Dr. Fenske said in an interview.
The discussion over ASCT in MCL is expected to evolve further in light of findings from TRIANGLE and EA4151, a randomized phase 3 trial of rituximab with or without ASCT specifically in patients with minimal residual disease (MRD)–negative MCL in first complete remission.
“If that study shows that the MRD-negative patients do not have much benefit from autologous transplantation,” Dr. Fenske said, “I think these studies will all be giving the same message – that autologous transplantation was beneficial back when induction regimens were poor (for example, CHOP without rituximab), but will have much less benefit in patients receiving modern inductions, which by and large will get more patients to be MRD negative.”
However, subgroup analyses of those TRIANGLE will be important, he added, since some patients may still benefit from ASCT, such as younger patients who remain MRD positive, or who have certain other high-risk molecular features.
Dr. Martin reported consulting or advisory roles with Janssen, BeiGene, Karyopharm Therapeutics, Kite/Gilead, Verastem, ADC Therapeutics, Bristol Myers Squibb/Celgene, Epizyme, Merck, MorphoSys, and Takeda. He reported institutional research funding from Karyopharm Therapeutics.
In younger patients with mantle cell lymphoma treated in U.S. community oncology settings in recent years, use of autologous transplant was not associated with improved survival, results of a large observational study show.
Autologous stem-cell transplant (ASCT) use was not linked overall survival (OS), according to the authors of the retrospective analysis of patients diagnosed with mantle cell lymphoma (MCL) between 2011 and 2021.
This lack of a clear survival benefit with use of ASCT is an “apparent contradiction” with prospective data from earlier clinical trials, authors wrote in the Journal of Clinical Oncology
However, they added, the finding is consistent with several recent registry analyses that also do not support a link between ASCT and overall survival in patients with MCL.
Although these findings are limited by the retrospective nature of the study, the results at least suggest that it is ethical to do research that doesn’t involve ASCT, study author Peter Martin, MD, said in an interview.
Furthermore, emerging data from the randomized TRIANGLE study from the European MCL Network suggest the potential for ASCT to be replaced by maintenance therapy with the Bruton's tyrosine kinase inhibitor ibrutinib, according to Dr. Martin, associate professor with Weill Cornell Medicine, New York.
“There are probably a lot of questions that will come up there, but essentially the barriers to research that do not include ASCT have been moved away, and we can go ahead and study non-ASCT (approaches) in younger patients,” Dr. Martin said.
No clear OS benefit
In current guidelines, recommended initial therapy for MCL patients younger than 65 years includes use of high-dose cytarabine-containing chemoimmunotherapy induction, followed by ASCT as consolidation, and then rituximab maintenance, Dr. Martin and coauthors say in their report.
Their primary analysis was based on the Flatiron Health database, which is derived from electronic medical records, mostly in U.S. community oncology practices, according to the report.
The researchers identified 1,274 patients under the age of 65 with a record of first-line treatment for MCL, and of those, 962 (or 76%) were considered eligible for ASCT.
Among ASCT-eligible patients, there was no significant association between receipt of ASCT and OS, with a hazard ratio of 0.86 (95% confidence interval, 0.63-1.18). The 3-year OS was 88% for patients receiving ASCT and similarly, 84% for those who did not, according to authors.
Likewise, there was no association between ASCT and real-world time to next treatment, an endpoint defined as time from start of first-line therapy to subsequent treatment or death, the report says.
Findings in perspective
The lack of clear survival benefit with ASCT in this and other recent observational studies may be explained in part by improvements in induction regimens, according to Timothy Fenske, MD, professor in the department of medicine at the Medical College of Wisconsin, Milwaukee.
“As our induction regimens have improved, it is very possible that the benefit for autologous transplantation will become less apparent,” Dr. Fenske said in an interview.
The discussion over ASCT in MCL is expected to evolve further in light of findings from TRIANGLE and EA4151, a randomized phase 3 trial of rituximab with or without ASCT specifically in patients with minimal residual disease (MRD)–negative MCL in first complete remission.
“If that study shows that the MRD-negative patients do not have much benefit from autologous transplantation,” Dr. Fenske said, “I think these studies will all be giving the same message – that autologous transplantation was beneficial back when induction regimens were poor (for example, CHOP without rituximab), but will have much less benefit in patients receiving modern inductions, which by and large will get more patients to be MRD negative.”
However, subgroup analyses of those TRIANGLE will be important, he added, since some patients may still benefit from ASCT, such as younger patients who remain MRD positive, or who have certain other high-risk molecular features.
Dr. Martin reported consulting or advisory roles with Janssen, BeiGene, Karyopharm Therapeutics, Kite/Gilead, Verastem, ADC Therapeutics, Bristol Myers Squibb/Celgene, Epizyme, Merck, MorphoSys, and Takeda. He reported institutional research funding from Karyopharm Therapeutics.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
FDA approves olutasidenib for some AML patients
Specifically, the drug is approved for use in patients who have R/R AML with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation as detected by an FDA-approved test.
The FDA also approved the Abbott RealTime IDH1 Assay to select patients for treatment.
Olutasidenib is an oral inhibitor of mutated IDH1 that has been designed to bind and inhibit mutated IDH1 to reduce hydroxyglutarate levels and restore cellular differentiation of myeloid cells, says the manufacturer, Rigel.
About half of all patients with AML have relapse after treatment and remission, and about 10%-40% have refractory cases and do not achieve remission even after intensive treatment, the company noted.
“Given the limited treatment options for adult patients with mIDH1 R/R AML, who typically have a poor prognosis, olutasidenib may provide an effective new treatment option with a well-characterized safety profile,” Jorges Cortes, MD, director of the Georgia Cancer Center, Augusta, commented in the company press release. He was an investigator on the phase 2 trial that led to the drug’s approval.
This was Study 2102-HEM-101 (NCT02719574), an open-label, single-arm, multicenter clinical trial that included 147 adult patients with relapsed or refractory AML with an IDH1 mutation confirmed using the Abbott assay.
Olutasidenib was given orally at 150 mg twice daily until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation (performed in 16 patients [11%]). The median treatment duration was 4.7 months (range, 0.1-26 months).
The FDA noted that efficacy was established on the rate of complete remission (CR) plus complete remission with partial hematologic recovery (CRh), the duration of CR+CRh, and the rate of conversion from transfusion dependence to independence.
The CR+CRh rate was 35% (95% confidence interval, 27%-43%), including 32% CR and 2.7% CRh. The median time to CR+CRh was 1.9 months (range, 0.9-5.6 months), and the median duration of CR+CRh was 25.9 months (95% CI, 13.5 months to not reached).
Commenting on these results in the company statement, Dr. Cortes noted that among the patients who responded, more than 90% were experiencing incomplete remission. He added that the “25.9 months median duration of CR+CRh is a clinically meaningful improvement for AML patients and appears to be longer than currently available treatment options.”
The FDA also noted that among the 86 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 29 (34%) became independent of RBC and platelet transfusions during any 56-day postbaseline period.
Of the 61 patients who were independent of both RBC and platelet transfusions at baseline, 39 (64%) remained transfusion-independent during any 56-day post-baseline period.
The most common adverse reactions (≥ 20%) were nausea, fatigue/malaise, arthralgia, constipation, leukocytosis, dyspnea, fever, rash, mucositis, diarrhea, and transaminitis.
The prescribing information contains a boxed warning about the risk for differentiation syndrome, which can be fatal.
Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal, the company explained. Symptoms may include leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.
In the trial, differentiation syndrome was observed in 16% of patients, with grade 3 or 4 occurring in 8% of patients treated and death in 1% of patients. It occurred as early as 1 day and up to 18 months after starting treatment.
In most cases, differentiation syndrome was manageable with dose interruption and corticosteroids, the company said. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption.
Further details are available in the full prescribing information.
A version of this article first appeared on Medscape.com.
Specifically, the drug is approved for use in patients who have R/R AML with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation as detected by an FDA-approved test.
The FDA also approved the Abbott RealTime IDH1 Assay to select patients for treatment.
Olutasidenib is an oral inhibitor of mutated IDH1 that has been designed to bind and inhibit mutated IDH1 to reduce hydroxyglutarate levels and restore cellular differentiation of myeloid cells, says the manufacturer, Rigel.
About half of all patients with AML have relapse after treatment and remission, and about 10%-40% have refractory cases and do not achieve remission even after intensive treatment, the company noted.
“Given the limited treatment options for adult patients with mIDH1 R/R AML, who typically have a poor prognosis, olutasidenib may provide an effective new treatment option with a well-characterized safety profile,” Jorges Cortes, MD, director of the Georgia Cancer Center, Augusta, commented in the company press release. He was an investigator on the phase 2 trial that led to the drug’s approval.
This was Study 2102-HEM-101 (NCT02719574), an open-label, single-arm, multicenter clinical trial that included 147 adult patients with relapsed or refractory AML with an IDH1 mutation confirmed using the Abbott assay.
Olutasidenib was given orally at 150 mg twice daily until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation (performed in 16 patients [11%]). The median treatment duration was 4.7 months (range, 0.1-26 months).
The FDA noted that efficacy was established on the rate of complete remission (CR) plus complete remission with partial hematologic recovery (CRh), the duration of CR+CRh, and the rate of conversion from transfusion dependence to independence.
The CR+CRh rate was 35% (95% confidence interval, 27%-43%), including 32% CR and 2.7% CRh. The median time to CR+CRh was 1.9 months (range, 0.9-5.6 months), and the median duration of CR+CRh was 25.9 months (95% CI, 13.5 months to not reached).
Commenting on these results in the company statement, Dr. Cortes noted that among the patients who responded, more than 90% were experiencing incomplete remission. He added that the “25.9 months median duration of CR+CRh is a clinically meaningful improvement for AML patients and appears to be longer than currently available treatment options.”
The FDA also noted that among the 86 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 29 (34%) became independent of RBC and platelet transfusions during any 56-day postbaseline period.
Of the 61 patients who were independent of both RBC and platelet transfusions at baseline, 39 (64%) remained transfusion-independent during any 56-day post-baseline period.
The most common adverse reactions (≥ 20%) were nausea, fatigue/malaise, arthralgia, constipation, leukocytosis, dyspnea, fever, rash, mucositis, diarrhea, and transaminitis.
The prescribing information contains a boxed warning about the risk for differentiation syndrome, which can be fatal.
Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal, the company explained. Symptoms may include leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.
In the trial, differentiation syndrome was observed in 16% of patients, with grade 3 or 4 occurring in 8% of patients treated and death in 1% of patients. It occurred as early as 1 day and up to 18 months after starting treatment.
In most cases, differentiation syndrome was manageable with dose interruption and corticosteroids, the company said. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption.
Further details are available in the full prescribing information.
A version of this article first appeared on Medscape.com.
Specifically, the drug is approved for use in patients who have R/R AML with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation as detected by an FDA-approved test.
The FDA also approved the Abbott RealTime IDH1 Assay to select patients for treatment.
Olutasidenib is an oral inhibitor of mutated IDH1 that has been designed to bind and inhibit mutated IDH1 to reduce hydroxyglutarate levels and restore cellular differentiation of myeloid cells, says the manufacturer, Rigel.
About half of all patients with AML have relapse after treatment and remission, and about 10%-40% have refractory cases and do not achieve remission even after intensive treatment, the company noted.
“Given the limited treatment options for adult patients with mIDH1 R/R AML, who typically have a poor prognosis, olutasidenib may provide an effective new treatment option with a well-characterized safety profile,” Jorges Cortes, MD, director of the Georgia Cancer Center, Augusta, commented in the company press release. He was an investigator on the phase 2 trial that led to the drug’s approval.
This was Study 2102-HEM-101 (NCT02719574), an open-label, single-arm, multicenter clinical trial that included 147 adult patients with relapsed or refractory AML with an IDH1 mutation confirmed using the Abbott assay.
Olutasidenib was given orally at 150 mg twice daily until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation (performed in 16 patients [11%]). The median treatment duration was 4.7 months (range, 0.1-26 months).
The FDA noted that efficacy was established on the rate of complete remission (CR) plus complete remission with partial hematologic recovery (CRh), the duration of CR+CRh, and the rate of conversion from transfusion dependence to independence.
The CR+CRh rate was 35% (95% confidence interval, 27%-43%), including 32% CR and 2.7% CRh. The median time to CR+CRh was 1.9 months (range, 0.9-5.6 months), and the median duration of CR+CRh was 25.9 months (95% CI, 13.5 months to not reached).
Commenting on these results in the company statement, Dr. Cortes noted that among the patients who responded, more than 90% were experiencing incomplete remission. He added that the “25.9 months median duration of CR+CRh is a clinically meaningful improvement for AML patients and appears to be longer than currently available treatment options.”
The FDA also noted that among the 86 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 29 (34%) became independent of RBC and platelet transfusions during any 56-day postbaseline period.
Of the 61 patients who were independent of both RBC and platelet transfusions at baseline, 39 (64%) remained transfusion-independent during any 56-day post-baseline period.
The most common adverse reactions (≥ 20%) were nausea, fatigue/malaise, arthralgia, constipation, leukocytosis, dyspnea, fever, rash, mucositis, diarrhea, and transaminitis.
The prescribing information contains a boxed warning about the risk for differentiation syndrome, which can be fatal.
Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal, the company explained. Symptoms may include leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.
In the trial, differentiation syndrome was observed in 16% of patients, with grade 3 or 4 occurring in 8% of patients treated and death in 1% of patients. It occurred as early as 1 day and up to 18 months after starting treatment.
In most cases, differentiation syndrome was manageable with dose interruption and corticosteroids, the company said. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption.
Further details are available in the full prescribing information.
A version of this article first appeared on Medscape.com.
Commentary: Risk factors and treatment for pediatric migraine, December 2022
This month, we will take a look at three new studies investigating risk factors and treatments for headache in children.
Stress has long been noted to be one of the most consistent triggers for migraine attacks. Much has been written and studied regarding the effect of migraine on mood in adults; however, few studies have done the same in the pediatric and adolescent population. Childhood trauma has been associated with the development of chronic migraine as an adult, and behavioral treatments, such as cognitive-behavioral therapy and biofeedback, are considered as effective or more effective for migraine prevention in children compared with preventive medications. Falla and colleagues have quantified the risk for anxiety and depression in children and adolescents with migraine.
The "internalization of symptoms" is defined by the authors as an individual's tendency to react to stress with physical symptoms, including anxiety and depression. These are thought to be elevated in children and adolescents with many effects, including migraine. However, no correlation has yet been shown. Beyond the internalization of symptoms, specific psychiatric diagnoses may also be more prominent in this population.
This study was a meta-analysis of data pooled from studies that assessed migraine-related symptoms as they relate to disorders on the spectrum of anxiety, depression, and trauma-related disorders. Any studies with participants older than 18 years were excluded from this analysis. A total of 80 studies were included. Anxiety symptoms were seen to be significantly higher in children and adolescents with migraine compared to controls and the odds of having an anxiety disorder were higher among those with migraine compared with controls. Depressive symptoms were also significantly higher; however, this effect size was much smaller. The incidence of migraine was not different than that of other headache disorders.
Many patients describe stress as a trigger for migraine and other headache attacks. Mood disorders and childhood trauma are associated with the development of chronic migraine as an adult. This study reveals a two-way connection between mood disorders and headache diagnoses in children. Screening for the underlying symptoms of depression and anxiety should be done when evaluating children and adolescents for headache disorders, and there should be a focus on the treatment of these conditions in addition to treating the headache symptoms.
There are, unfortunately, very few acute pediatric migraine trials. Only a handful of medications have actually been investigated for the treatment of migraine in children younger than 12 years, and only one migraine-specific medication, rizatriptan, is approved in the United States for pediatric use. Because of this, many argue that children and adolescents with migraines end up overusing over-the-counter medication options, increasing the risk for medication overuse headache. In addition, many patients need nonoral acute migraine treatments due to nausea and vomiting or rapid onset migraine attacks.
Yonker and colleagues conducted a phase 3, randomized, double-blind, multicenter trial that only enrolled patients aged 6-11 years, all of whom had a diagnosis of episodic migraine (< 15 days of migraine per month). Children that weighed < 50 kg were given a randomly assigned lower dose of 1 mg or 2.5 mg zolmitriptan nasal spray, and those who weighed > 50 kg were randomly assigned to either 2.5 mg or 5 mg, which is the standard adult dose.
The primary outcome was a standard 2-hour pain freedom level; secondary outcomes included the proportion of improvement at 0.5, 1, and 24 hours post-dose, as well as sustained headache response for the following 2-24 hours and time to rescue medication use. Although 300 patients were enrolled and taken through the run-in process, 114 were discontinued either due to placebo response or because they had no treated migraine during the run-in phase. The mean age was 9.2 years and half of the patients were girls (of note, this is considered an appropriate proportion for pediatric migraine).
The primary endpoint of 2-hour pain freedom was not met; however, more patients in the high-dose treatment group were pain-free after 2 hours than in the placebo group. Several secondary endpoints did achieve statistical significance, including pain-free status at 1 hour post-dose, as well as headache response at 0.5, 1, and 2 hours — all of which were lower in the high-dose treatment group. The lower-dose treatment group was statistically similar to placebo for all the timepoints noted above. Treatment-related adverse events were rare in all groups.
This study did not meet its primary efficacy endpoint. However, it does show safety and effectiveness, enough at least to broaden the use of zolmitriptan for pediatric migraine. Many more effective medications for migraine treatment in adults should follow the lead of this group to find better and more specific treatments for children with migraine.
As we noted above, childhood trauma is associated with the development of chronic migraine in adulthood. Prior studies have defined childhood trauma as physical or emotional abuse primarily, and the correlation between childhood illnesses and headache disorder has not previously been determined. Davidsson and colleagues published a study in the Journal of Cancer Epidemiology that reviewed nationwide database registers longitudinally to better understand this potential risk factor.
The Danish Cancer Register was reviewed for the purpose of identifying anyone in the general Danish population who developed a diagnosis of cancer before age 20 years. The individual identification numbers in that register were linked to data in other nationwide registers for the purpose of determining whether those individuals initiated migraine-specific medications or were admitted for an inpatient hospitalization for migraine. Study participants were also grouped based on cancer type, specifically hematologic cancers involving chemotherapy and central nervous system-directed therapies, brain tumors needing intracranial surgery or radiation to the brain, blastomas or other solid tumors outside of the central nervous system, sarcomas treated with an alkylating chemotherapy, and all other carcinomas.
Among all individuals diagnosed with a childhood cancer, there was a significant increase in overall risk for the need to initiate antimigraine medication. Of interest, this was higher in those diagnosed in their teenage years. Migraine hospitalization was also noted to be higher in nearly all strata, with the exception of those diagnosed with cancer prior to the age of 5 years. The highest risk was also noted in individuals with hematologic cancers, blastomas, and brain tumors as opposed to those with sarcomas and other carcinomas. The highest cumulative risk for migraine remains in those who were diagnosed with cancer between ages 15 and 19 years.
This month, we will take a look at three new studies investigating risk factors and treatments for headache in children.
Stress has long been noted to be one of the most consistent triggers for migraine attacks. Much has been written and studied regarding the effect of migraine on mood in adults; however, few studies have done the same in the pediatric and adolescent population. Childhood trauma has been associated with the development of chronic migraine as an adult, and behavioral treatments, such as cognitive-behavioral therapy and biofeedback, are considered as effective or more effective for migraine prevention in children compared with preventive medications. Falla and colleagues have quantified the risk for anxiety and depression in children and adolescents with migraine.
The "internalization of symptoms" is defined by the authors as an individual's tendency to react to stress with physical symptoms, including anxiety and depression. These are thought to be elevated in children and adolescents with many effects, including migraine. However, no correlation has yet been shown. Beyond the internalization of symptoms, specific psychiatric diagnoses may also be more prominent in this population.
This study was a meta-analysis of data pooled from studies that assessed migraine-related symptoms as they relate to disorders on the spectrum of anxiety, depression, and trauma-related disorders. Any studies with participants older than 18 years were excluded from this analysis. A total of 80 studies were included. Anxiety symptoms were seen to be significantly higher in children and adolescents with migraine compared to controls and the odds of having an anxiety disorder were higher among those with migraine compared with controls. Depressive symptoms were also significantly higher; however, this effect size was much smaller. The incidence of migraine was not different than that of other headache disorders.
Many patients describe stress as a trigger for migraine and other headache attacks. Mood disorders and childhood trauma are associated with the development of chronic migraine as an adult. This study reveals a two-way connection between mood disorders and headache diagnoses in children. Screening for the underlying symptoms of depression and anxiety should be done when evaluating children and adolescents for headache disorders, and there should be a focus on the treatment of these conditions in addition to treating the headache symptoms.
There are, unfortunately, very few acute pediatric migraine trials. Only a handful of medications have actually been investigated for the treatment of migraine in children younger than 12 years, and only one migraine-specific medication, rizatriptan, is approved in the United States for pediatric use. Because of this, many argue that children and adolescents with migraines end up overusing over-the-counter medication options, increasing the risk for medication overuse headache. In addition, many patients need nonoral acute migraine treatments due to nausea and vomiting or rapid onset migraine attacks.
Yonker and colleagues conducted a phase 3, randomized, double-blind, multicenter trial that only enrolled patients aged 6-11 years, all of whom had a diagnosis of episodic migraine (< 15 days of migraine per month). Children that weighed < 50 kg were given a randomly assigned lower dose of 1 mg or 2.5 mg zolmitriptan nasal spray, and those who weighed > 50 kg were randomly assigned to either 2.5 mg or 5 mg, which is the standard adult dose.
The primary outcome was a standard 2-hour pain freedom level; secondary outcomes included the proportion of improvement at 0.5, 1, and 24 hours post-dose, as well as sustained headache response for the following 2-24 hours and time to rescue medication use. Although 300 patients were enrolled and taken through the run-in process, 114 were discontinued either due to placebo response or because they had no treated migraine during the run-in phase. The mean age was 9.2 years and half of the patients were girls (of note, this is considered an appropriate proportion for pediatric migraine).
The primary endpoint of 2-hour pain freedom was not met; however, more patients in the high-dose treatment group were pain-free after 2 hours than in the placebo group. Several secondary endpoints did achieve statistical significance, including pain-free status at 1 hour post-dose, as well as headache response at 0.5, 1, and 2 hours — all of which were lower in the high-dose treatment group. The lower-dose treatment group was statistically similar to placebo for all the timepoints noted above. Treatment-related adverse events were rare in all groups.
This study did not meet its primary efficacy endpoint. However, it does show safety and effectiveness, enough at least to broaden the use of zolmitriptan for pediatric migraine. Many more effective medications for migraine treatment in adults should follow the lead of this group to find better and more specific treatments for children with migraine.
As we noted above, childhood trauma is associated with the development of chronic migraine in adulthood. Prior studies have defined childhood trauma as physical or emotional abuse primarily, and the correlation between childhood illnesses and headache disorder has not previously been determined. Davidsson and colleagues published a study in the Journal of Cancer Epidemiology that reviewed nationwide database registers longitudinally to better understand this potential risk factor.
The Danish Cancer Register was reviewed for the purpose of identifying anyone in the general Danish population who developed a diagnosis of cancer before age 20 years. The individual identification numbers in that register were linked to data in other nationwide registers for the purpose of determining whether those individuals initiated migraine-specific medications or were admitted for an inpatient hospitalization for migraine. Study participants were also grouped based on cancer type, specifically hematologic cancers involving chemotherapy and central nervous system-directed therapies, brain tumors needing intracranial surgery or radiation to the brain, blastomas or other solid tumors outside of the central nervous system, sarcomas treated with an alkylating chemotherapy, and all other carcinomas.
Among all individuals diagnosed with a childhood cancer, there was a significant increase in overall risk for the need to initiate antimigraine medication. Of interest, this was higher in those diagnosed in their teenage years. Migraine hospitalization was also noted to be higher in nearly all strata, with the exception of those diagnosed with cancer prior to the age of 5 years. The highest risk was also noted in individuals with hematologic cancers, blastomas, and brain tumors as opposed to those with sarcomas and other carcinomas. The highest cumulative risk for migraine remains in those who were diagnosed with cancer between ages 15 and 19 years.
This month, we will take a look at three new studies investigating risk factors and treatments for headache in children.
Stress has long been noted to be one of the most consistent triggers for migraine attacks. Much has been written and studied regarding the effect of migraine on mood in adults; however, few studies have done the same in the pediatric and adolescent population. Childhood trauma has been associated with the development of chronic migraine as an adult, and behavioral treatments, such as cognitive-behavioral therapy and biofeedback, are considered as effective or more effective for migraine prevention in children compared with preventive medications. Falla and colleagues have quantified the risk for anxiety and depression in children and adolescents with migraine.
The "internalization of symptoms" is defined by the authors as an individual's tendency to react to stress with physical symptoms, including anxiety and depression. These are thought to be elevated in children and adolescents with many effects, including migraine. However, no correlation has yet been shown. Beyond the internalization of symptoms, specific psychiatric diagnoses may also be more prominent in this population.
This study was a meta-analysis of data pooled from studies that assessed migraine-related symptoms as they relate to disorders on the spectrum of anxiety, depression, and trauma-related disorders. Any studies with participants older than 18 years were excluded from this analysis. A total of 80 studies were included. Anxiety symptoms were seen to be significantly higher in children and adolescents with migraine compared to controls and the odds of having an anxiety disorder were higher among those with migraine compared with controls. Depressive symptoms were also significantly higher; however, this effect size was much smaller. The incidence of migraine was not different than that of other headache disorders.
Many patients describe stress as a trigger for migraine and other headache attacks. Mood disorders and childhood trauma are associated with the development of chronic migraine as an adult. This study reveals a two-way connection between mood disorders and headache diagnoses in children. Screening for the underlying symptoms of depression and anxiety should be done when evaluating children and adolescents for headache disorders, and there should be a focus on the treatment of these conditions in addition to treating the headache symptoms.
There are, unfortunately, very few acute pediatric migraine trials. Only a handful of medications have actually been investigated for the treatment of migraine in children younger than 12 years, and only one migraine-specific medication, rizatriptan, is approved in the United States for pediatric use. Because of this, many argue that children and adolescents with migraines end up overusing over-the-counter medication options, increasing the risk for medication overuse headache. In addition, many patients need nonoral acute migraine treatments due to nausea and vomiting or rapid onset migraine attacks.
Yonker and colleagues conducted a phase 3, randomized, double-blind, multicenter trial that only enrolled patients aged 6-11 years, all of whom had a diagnosis of episodic migraine (< 15 days of migraine per month). Children that weighed < 50 kg were given a randomly assigned lower dose of 1 mg or 2.5 mg zolmitriptan nasal spray, and those who weighed > 50 kg were randomly assigned to either 2.5 mg or 5 mg, which is the standard adult dose.
The primary outcome was a standard 2-hour pain freedom level; secondary outcomes included the proportion of improvement at 0.5, 1, and 24 hours post-dose, as well as sustained headache response for the following 2-24 hours and time to rescue medication use. Although 300 patients were enrolled and taken through the run-in process, 114 were discontinued either due to placebo response or because they had no treated migraine during the run-in phase. The mean age was 9.2 years and half of the patients were girls (of note, this is considered an appropriate proportion for pediatric migraine).
The primary endpoint of 2-hour pain freedom was not met; however, more patients in the high-dose treatment group were pain-free after 2 hours than in the placebo group. Several secondary endpoints did achieve statistical significance, including pain-free status at 1 hour post-dose, as well as headache response at 0.5, 1, and 2 hours — all of which were lower in the high-dose treatment group. The lower-dose treatment group was statistically similar to placebo for all the timepoints noted above. Treatment-related adverse events were rare in all groups.
This study did not meet its primary efficacy endpoint. However, it does show safety and effectiveness, enough at least to broaden the use of zolmitriptan for pediatric migraine. Many more effective medications for migraine treatment in adults should follow the lead of this group to find better and more specific treatments for children with migraine.
As we noted above, childhood trauma is associated with the development of chronic migraine in adulthood. Prior studies have defined childhood trauma as physical or emotional abuse primarily, and the correlation between childhood illnesses and headache disorder has not previously been determined. Davidsson and colleagues published a study in the Journal of Cancer Epidemiology that reviewed nationwide database registers longitudinally to better understand this potential risk factor.
The Danish Cancer Register was reviewed for the purpose of identifying anyone in the general Danish population who developed a diagnosis of cancer before age 20 years. The individual identification numbers in that register were linked to data in other nationwide registers for the purpose of determining whether those individuals initiated migraine-specific medications or were admitted for an inpatient hospitalization for migraine. Study participants were also grouped based on cancer type, specifically hematologic cancers involving chemotherapy and central nervous system-directed therapies, brain tumors needing intracranial surgery or radiation to the brain, blastomas or other solid tumors outside of the central nervous system, sarcomas treated with an alkylating chemotherapy, and all other carcinomas.
Among all individuals diagnosed with a childhood cancer, there was a significant increase in overall risk for the need to initiate antimigraine medication. Of interest, this was higher in those diagnosed in their teenage years. Migraine hospitalization was also noted to be higher in nearly all strata, with the exception of those diagnosed with cancer prior to the age of 5 years. The highest risk was also noted in individuals with hematologic cancers, blastomas, and brain tumors as opposed to those with sarcomas and other carcinomas. The highest cumulative risk for migraine remains in those who were diagnosed with cancer between ages 15 and 19 years.
Tips and tricks for a successful rollerball endometrial ablation
How can clinicians distinguish food allergy and GERD in young kids?
The debate about a possible link between food allergy (FA) and pediatric gastroesophageal reflux disease (GERD) continues, and more, better-designed research is needed, a position paper by the European Academy of Allergy and Clinical Immunology reports.
The report offers consensus-based recommendations and a graphical decision pathway to guide providers through assessing and treating food allergy–related GERD. And the authors call for further, better-designed related research.
Food allergy and GERD are common in babies under 1 year of age and can lead to bothersome GERD, the authors write.
“An extensive literature search has found that whilst food proteins, in particular cow milk protein, can be a contributing factor to FA-associated” GERD, distinguishing between FA and non–FA-associated GERD is difficult, lead author Rosan Meyer, RD, PhD, senior lecturer at Imperial College London, and colleagues from the Academy task force on non-IgE mediated allergy, write in Pediatric Allergy and Immunology.
Consensus despite limited data
Dr. Meyer and colleagues developed clinical questions that addressed various aspects of the relationship between food allergy and GERD – pathophysiology, symptoms, diagnosis, dietary and medical management, prevalence, and impact on quality of life.
To address these issues, they systematically searched the literature for randomized controlled, observational, case-control, and retrospective studies of infants and children diagnosed with non-IgE gastrointestinal food allergies and GERD, published in English until February 2021.
Because of limited data in many of these areas, they used a modified Delphi method to reach consensus and provide practical advice on food allergy–associated GERD management.
The task force concludes:
- Food proteins, especially cow’s milk protein, can contribute to food allergy–associated GERD. The confirmation of food allergy is based on the elimination diet, always followed by reintroducing the offending allergen, and the diagnosis and treatment pathway should consider effects on quality of life.
- Breastfeeding should be supported in food allergy–associated GERD, and dietary advice should consider the potential nutritional impact on the breastfeeding mother. When breast milk is not available or is insufficient, formula and dietary advice to counteract the child’s nutrient deficiencies should be considered.
- Although some clarity exists about when GERD medications may be considered, they are often used inappropriately and may harm patients, especially infants.
Rigorous research needed
“Clinicians can use this algorithm to help them identify patients who may be affected by food allergy–related GERD,” Jonathan Tam, MD, medical director of the Gores Family Allergy Center at Children’s Hospital Los Angeles, told this news organization by email.
“Clinicians who suspect their patients may have food allergy–related GERD now have clearer guidance on how to systemically evaluate their patients,” added Dr. Tam, who was not involved in developing the report.
“Many allergists fear that patients may be labeled with a food allergy unnecessarily. Because no biomarkers or tests for food allergy–related GERD are available, elimination diets are a crucial part of the evaluation,” he said.
Dr. Tam added that the authors point out two key parts of a trial elimination: First, the trial should last at least 2 weeks, but full resolution may not occur until 6 weeks. Second, targeted elimination must be followed by reintroduction to confirm that the food was causing the symptoms, not that time itself may have been responsible for the clinical change.
“The authors’ note on allergy testing is important,” he said. “Allergy testing is not necessary when a clinician is concerned about food allergy–related GERD unless there are other associated atopic comorbidities, like eczema or IgE-mediated immediate food allergies.”
Jonathan M. Spergel, MD, PhD, chief of the allergy section at Children’s Hospital of Philadelphia, said in an email that families often ask whether food allergy is causing their child’s reflux.
“Both conditions are common and, in most cases, may not be related. As the report highlights, the risk of food allergy is increased if the patient has other atopic disease (atopic dermatitis), and standard allergy testing (skin testing, specific IgE) and IgG4 testing are not recommended,” he explained. “Food allergy in a patient with reflux can be considered if standard therapy is failing.”
Expert opinion on diagnosis and management
Dr. Spergel, also not involved in the report, joined the authors in advocating further, stronger studies. “While the expert opinion is a major strength,” he said, “with most available studies being neither randomized nor placebo-controlled, the true prevalence of food allergy reflux is unknown.”
Jay M. Portnoy, MD, specialist in pediatric allergy and immunology and medical director of telemedicine at Children’s Mercy Kansas City, said: “While most physicians believe that food allergy contributes to GERD, the evidence for the relationship is minimal. Reflux often occurs regardless of what food is eaten,” said Dr. Portnoy, who was not associated with the research.
Before removing a food from the diet, it’s important to determine whether that food is causing the problem, he urged.
“Blaming a food is easy. Food allergy is often suspected to cause symptoms it does not cause,” he said. “This unfounded blame can lead to unnecessary avoidance, reduce a family’s quality of life, and cause malnutrition.
“How a child is evaluated and treated depends as much on which physician they see as on whether the food is the culprit,” Dr. Portnoy said. “This report is an attempt to clarify the issues and to standardize an approach to the condition, so each provider evaluates and manages the condition in a consistent and evidence-based manner.
“It is important to see how well this report is incorporated into practice and whether following its guidance actually improves patient care,” Dr. Portnoy noted.
Funding information was not provided. Dr. Meyer and two coauthors report financial relationships with the nutritional health care industry. The full list can be found with the original article. The remaining authors and Dr. Tam, Dr. Spergel, and Dr. Portnoy report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The debate about a possible link between food allergy (FA) and pediatric gastroesophageal reflux disease (GERD) continues, and more, better-designed research is needed, a position paper by the European Academy of Allergy and Clinical Immunology reports.
The report offers consensus-based recommendations and a graphical decision pathway to guide providers through assessing and treating food allergy–related GERD. And the authors call for further, better-designed related research.
Food allergy and GERD are common in babies under 1 year of age and can lead to bothersome GERD, the authors write.
“An extensive literature search has found that whilst food proteins, in particular cow milk protein, can be a contributing factor to FA-associated” GERD, distinguishing between FA and non–FA-associated GERD is difficult, lead author Rosan Meyer, RD, PhD, senior lecturer at Imperial College London, and colleagues from the Academy task force on non-IgE mediated allergy, write in Pediatric Allergy and Immunology.
Consensus despite limited data
Dr. Meyer and colleagues developed clinical questions that addressed various aspects of the relationship between food allergy and GERD – pathophysiology, symptoms, diagnosis, dietary and medical management, prevalence, and impact on quality of life.
To address these issues, they systematically searched the literature for randomized controlled, observational, case-control, and retrospective studies of infants and children diagnosed with non-IgE gastrointestinal food allergies and GERD, published in English until February 2021.
Because of limited data in many of these areas, they used a modified Delphi method to reach consensus and provide practical advice on food allergy–associated GERD management.
The task force concludes:
- Food proteins, especially cow’s milk protein, can contribute to food allergy–associated GERD. The confirmation of food allergy is based on the elimination diet, always followed by reintroducing the offending allergen, and the diagnosis and treatment pathway should consider effects on quality of life.
- Breastfeeding should be supported in food allergy–associated GERD, and dietary advice should consider the potential nutritional impact on the breastfeeding mother. When breast milk is not available or is insufficient, formula and dietary advice to counteract the child’s nutrient deficiencies should be considered.
- Although some clarity exists about when GERD medications may be considered, they are often used inappropriately and may harm patients, especially infants.
Rigorous research needed
“Clinicians can use this algorithm to help them identify patients who may be affected by food allergy–related GERD,” Jonathan Tam, MD, medical director of the Gores Family Allergy Center at Children’s Hospital Los Angeles, told this news organization by email.
“Clinicians who suspect their patients may have food allergy–related GERD now have clearer guidance on how to systemically evaluate their patients,” added Dr. Tam, who was not involved in developing the report.
“Many allergists fear that patients may be labeled with a food allergy unnecessarily. Because no biomarkers or tests for food allergy–related GERD are available, elimination diets are a crucial part of the evaluation,” he said.
Dr. Tam added that the authors point out two key parts of a trial elimination: First, the trial should last at least 2 weeks, but full resolution may not occur until 6 weeks. Second, targeted elimination must be followed by reintroduction to confirm that the food was causing the symptoms, not that time itself may have been responsible for the clinical change.
“The authors’ note on allergy testing is important,” he said. “Allergy testing is not necessary when a clinician is concerned about food allergy–related GERD unless there are other associated atopic comorbidities, like eczema or IgE-mediated immediate food allergies.”
Jonathan M. Spergel, MD, PhD, chief of the allergy section at Children’s Hospital of Philadelphia, said in an email that families often ask whether food allergy is causing their child’s reflux.
“Both conditions are common and, in most cases, may not be related. As the report highlights, the risk of food allergy is increased if the patient has other atopic disease (atopic dermatitis), and standard allergy testing (skin testing, specific IgE) and IgG4 testing are not recommended,” he explained. “Food allergy in a patient with reflux can be considered if standard therapy is failing.”
Expert opinion on diagnosis and management
Dr. Spergel, also not involved in the report, joined the authors in advocating further, stronger studies. “While the expert opinion is a major strength,” he said, “with most available studies being neither randomized nor placebo-controlled, the true prevalence of food allergy reflux is unknown.”
Jay M. Portnoy, MD, specialist in pediatric allergy and immunology and medical director of telemedicine at Children’s Mercy Kansas City, said: “While most physicians believe that food allergy contributes to GERD, the evidence for the relationship is minimal. Reflux often occurs regardless of what food is eaten,” said Dr. Portnoy, who was not associated with the research.
Before removing a food from the diet, it’s important to determine whether that food is causing the problem, he urged.
“Blaming a food is easy. Food allergy is often suspected to cause symptoms it does not cause,” he said. “This unfounded blame can lead to unnecessary avoidance, reduce a family’s quality of life, and cause malnutrition.
“How a child is evaluated and treated depends as much on which physician they see as on whether the food is the culprit,” Dr. Portnoy said. “This report is an attempt to clarify the issues and to standardize an approach to the condition, so each provider evaluates and manages the condition in a consistent and evidence-based manner.
“It is important to see how well this report is incorporated into practice and whether following its guidance actually improves patient care,” Dr. Portnoy noted.
Funding information was not provided. Dr. Meyer and two coauthors report financial relationships with the nutritional health care industry. The full list can be found with the original article. The remaining authors and Dr. Tam, Dr. Spergel, and Dr. Portnoy report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The debate about a possible link between food allergy (FA) and pediatric gastroesophageal reflux disease (GERD) continues, and more, better-designed research is needed, a position paper by the European Academy of Allergy and Clinical Immunology reports.
The report offers consensus-based recommendations and a graphical decision pathway to guide providers through assessing and treating food allergy–related GERD. And the authors call for further, better-designed related research.
Food allergy and GERD are common in babies under 1 year of age and can lead to bothersome GERD, the authors write.
“An extensive literature search has found that whilst food proteins, in particular cow milk protein, can be a contributing factor to FA-associated” GERD, distinguishing between FA and non–FA-associated GERD is difficult, lead author Rosan Meyer, RD, PhD, senior lecturer at Imperial College London, and colleagues from the Academy task force on non-IgE mediated allergy, write in Pediatric Allergy and Immunology.
Consensus despite limited data
Dr. Meyer and colleagues developed clinical questions that addressed various aspects of the relationship between food allergy and GERD – pathophysiology, symptoms, diagnosis, dietary and medical management, prevalence, and impact on quality of life.
To address these issues, they systematically searched the literature for randomized controlled, observational, case-control, and retrospective studies of infants and children diagnosed with non-IgE gastrointestinal food allergies and GERD, published in English until February 2021.
Because of limited data in many of these areas, they used a modified Delphi method to reach consensus and provide practical advice on food allergy–associated GERD management.
The task force concludes:
- Food proteins, especially cow’s milk protein, can contribute to food allergy–associated GERD. The confirmation of food allergy is based on the elimination diet, always followed by reintroducing the offending allergen, and the diagnosis and treatment pathway should consider effects on quality of life.
- Breastfeeding should be supported in food allergy–associated GERD, and dietary advice should consider the potential nutritional impact on the breastfeeding mother. When breast milk is not available or is insufficient, formula and dietary advice to counteract the child’s nutrient deficiencies should be considered.
- Although some clarity exists about when GERD medications may be considered, they are often used inappropriately and may harm patients, especially infants.
Rigorous research needed
“Clinicians can use this algorithm to help them identify patients who may be affected by food allergy–related GERD,” Jonathan Tam, MD, medical director of the Gores Family Allergy Center at Children’s Hospital Los Angeles, told this news organization by email.
“Clinicians who suspect their patients may have food allergy–related GERD now have clearer guidance on how to systemically evaluate their patients,” added Dr. Tam, who was not involved in developing the report.
“Many allergists fear that patients may be labeled with a food allergy unnecessarily. Because no biomarkers or tests for food allergy–related GERD are available, elimination diets are a crucial part of the evaluation,” he said.
Dr. Tam added that the authors point out two key parts of a trial elimination: First, the trial should last at least 2 weeks, but full resolution may not occur until 6 weeks. Second, targeted elimination must be followed by reintroduction to confirm that the food was causing the symptoms, not that time itself may have been responsible for the clinical change.
“The authors’ note on allergy testing is important,” he said. “Allergy testing is not necessary when a clinician is concerned about food allergy–related GERD unless there are other associated atopic comorbidities, like eczema or IgE-mediated immediate food allergies.”
Jonathan M. Spergel, MD, PhD, chief of the allergy section at Children’s Hospital of Philadelphia, said in an email that families often ask whether food allergy is causing their child’s reflux.
“Both conditions are common and, in most cases, may not be related. As the report highlights, the risk of food allergy is increased if the patient has other atopic disease (atopic dermatitis), and standard allergy testing (skin testing, specific IgE) and IgG4 testing are not recommended,” he explained. “Food allergy in a patient with reflux can be considered if standard therapy is failing.”
Expert opinion on diagnosis and management
Dr. Spergel, also not involved in the report, joined the authors in advocating further, stronger studies. “While the expert opinion is a major strength,” he said, “with most available studies being neither randomized nor placebo-controlled, the true prevalence of food allergy reflux is unknown.”
Jay M. Portnoy, MD, specialist in pediatric allergy and immunology and medical director of telemedicine at Children’s Mercy Kansas City, said: “While most physicians believe that food allergy contributes to GERD, the evidence for the relationship is minimal. Reflux often occurs regardless of what food is eaten,” said Dr. Portnoy, who was not associated with the research.
Before removing a food from the diet, it’s important to determine whether that food is causing the problem, he urged.
“Blaming a food is easy. Food allergy is often suspected to cause symptoms it does not cause,” he said. “This unfounded blame can lead to unnecessary avoidance, reduce a family’s quality of life, and cause malnutrition.
“How a child is evaluated and treated depends as much on which physician they see as on whether the food is the culprit,” Dr. Portnoy said. “This report is an attempt to clarify the issues and to standardize an approach to the condition, so each provider evaluates and manages the condition in a consistent and evidence-based manner.
“It is important to see how well this report is incorporated into practice and whether following its guidance actually improves patient care,” Dr. Portnoy noted.
Funding information was not provided. Dr. Meyer and two coauthors report financial relationships with the nutritional health care industry. The full list can be found with the original article. The remaining authors and Dr. Tam, Dr. Spergel, and Dr. Portnoy report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Deductibles a threat to more imaging after abnormal mammogram
CHICAGO – One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.
“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.
However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.
Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.
Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
Groups most likely to forgo further tests
The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).
Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.
“It caught a lot of women by surprise,” she told this news organization.
The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.
However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
Reducing false-positive recalls
The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”
Physicians who order additional tests must also consider the financial burden for patients, she said.
Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.
Further compounding the problem is that not every insurer is subject to state law, she said.
Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.
“It would be great to have a federal law that is inclusive,” she said.
Education efforts may help
Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”
He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”
Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.
“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.
However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.
Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.
Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
Groups most likely to forgo further tests
The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).
Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.
“It caught a lot of women by surprise,” she told this news organization.
The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.
However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
Reducing false-positive recalls
The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”
Physicians who order additional tests must also consider the financial burden for patients, she said.
Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.
Further compounding the problem is that not every insurer is subject to state law, she said.
Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.
“It would be great to have a federal law that is inclusive,” she said.
Education efforts may help
Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”
He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”
Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – One in five women will skip further imaging after an abnormal mammogram if they have to pay out of pocket before their deductible is met, new data indicate.
“The ACA [Affordable Care Act] removed out-of-pocket costs for screening mammograms under most health plans to encourage women to partake in this important preventative health care measure,” Michael Ngo, MD, a radiology resident at Boston Medical Center and Boston University, said in a statement.
However, the screening mammogram is only the first step. If it’s abnormal, additional tests and a biopsy help determine whether the patient has cancer. The ACA does not mandate coverage for those, Dr. Ngo noted.
Dr. Ngo was lead author of the study presented at the annual meeting of the Radiological Society of North America.
Researchers collected 932 surveys. Asked whether they would skip follow-up imaging if they knew that they would have to pay a deductible, 151 of 714 (21.2%) said that they would skip the imaging; 424 (59.4%) said that they would not skip further imaging; and 139 (19.5%) were undecided. Responses differed by race, education level, household income, and insurance payer.
Groups most likely to forgo further tests
The groups with the highest percentage of persons who would skip additional imaging were Hispanic persons (33%); persons whose level of education was high school or less (31.0%); persons with a household income of less than $35,000 (27%); and those covered by Medicaid or who were uninsured (31.5%).
Wendie Berg, MD, PhD, professor of radiology at the University of Pittsburgh, who was not part of the study, said that because insurance companies had to cover initial mammograms fully under the ACA, “they generally increased deductibles. That resulted in more charges to patients when they came in for additional testing.
“It caught a lot of women by surprise,” she told this news organization.
The out-of-pocket charges can escalate with each step – more images, a biopsy, then more if they do have cancer, she said. This puts patients on the hook for hundreds, if not thousands, of dollars in medical bills.
However, Dr. Berg said, “The vast majority of women – 95% – who are called back for additional testing don’t have cancer. It is a problem that a lot of women will experience the cost and don’t have any benefit.”
Reducing false-positive recalls
The study highlights several things, she said. One is that “it’s incumbent on all of us to reduce false-positive recalls, which is one of the benefits of 3-D mammogram.”
Physicians who order additional tests must also consider the financial burden for patients, she said.
Some states have tackled the issue, she said. “Seven states do require insurance to cover diagnostic testing.” But those states differ in the extent of the coverage. DenseBreast-info.org, a website she helps with on a volunteer basis, explains the benefits by state.
Further compounding the problem is that not every insurer is subject to state law, she said.
Many states have programs that cover the cost for those who meet income requirements, although, she noted, some women make too much to qualify.
“It would be great to have a federal law that is inclusive,” she said.
Education efforts may help
Brian N. Dontchos, MD, with the University of Washington in Seattle, who was not part of the study, views the data another way. He told this news organization, “It is encouraging from the study that the majority of women would pursue additional imaging after an abnormal screening mammogram despite incurring more cost.”
He said that since direct patient education “has been shown to be effective in improving patient participation in screening programs, it is possible that, with more education of patients and providers, that advocacy could influence payers to support downstream imaging and biopsies that result from screening programs.”
Dr. Ngo, Dr. Berg, and Dr. Dontchos report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT RSNA 2022
Consider quality of life, comorbidities in hidradenitis suppurativa
LAS VEGAS – , Robert G. Micheletti, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
For patients with HS, “the quality-of-life impact is profound, greater than any other systematically studied dermatologic condition,” said Dr. Micheletti, associate professor of dermatology at the Hospital of the University of Pennsylavnia, and chief of hospital dermatology, and chief of dermatology at Pennsylvania Hospital, Philadelphia.
Two key aspects of quality of life that affect HS patients are sexual health and overall pain, he said. The female-to-male ratio of HS is approximately 3:1, and data show that approximately 40% of female HS patients experience fertility issues and have unaddressed questions about HS and pregnancy, said Dr. Micheletti. Additionally, data from a systematic review showed that 50%-60% of patients with HS reported sexual dysfunction. Impaired sexual function is also associated with both overall impaired quality of life ratings and the presence of mood disorders, he noted.
Pain also has a significant impact on quality of life for HS patients. When these patients present in an emergency department, 70% report severe pain, and approximately 60% receive opioids, said Dr. Micheletti.
Data from a 2021 study showed that HS patients are significantly more likely to receive opioids compared with controls, and also more likely to be diagnosed with opioid use disorder than controls, especially if they are seen by nondermatologists, he noted.
For acute pain, Dr. Micheletti recommended starting with acetaminophen 500 mg every 4 to 6 hours as needed, and topical nonsteroidal anti-inflammatory drugs (NSAIDs). “It still makes sense to do topical care,” said Dr. Micheletti, but he added that he also prescribes medications for anxiety for these patients.
Patients with increased pain severity or refractory disease may benefit from systemic NSAIDs, or intralesional triamcinolone, he noted. Incision and draining of abscesses may provide temporary symptomatic relief, but keep in mind that lesions will recur, he noted.
For the most severe cases, Dr. Micheletti advised adding tramadol as a first-line opioid, or another short-acting opioid for breakthrough pain.
To manage patients with HS who have chronic pain, Dr. Micheletti recommended starting with HS disease–directed therapy, but also screening for pain severity and psychological comorbidities.
His strategies in these cases include nonpharmacological pain management in the form of physical therapy, wound care, and behavioral health. His algorithm for nociceptive pain is NSAIDs with or without acetaminophen; duloxetine or nortriptyline are other options. For neuropathic pain, gabapentin and/or duloxetine are top choices, but pregabalin, venlafaxine, and nortriptyline are on the list as well.
Topical NSAIDs or topical lidocaine may serve as add-ons to systemic therapy in more severe cases, or as first-line therapy for milder chronic pain, Dr. Micheletti noted. Patients who have failed treatment with at least two pharmacologic agents, suffer medically refractory HS with debilitating pain, or use opioids on an ongoing basis should be referred to a pain management specialist, he said.
Don’t forget lifestyle
Although data on the impact of diet on patients with HS are limited, “we know anecdotally that dairy and refined carbohydrates are associated with exacerbations,” said Dr. Micheletti.
In addition, many patients use complementary medicine “and they aren’t always telling us,” he emphasized. Smoking is prevalent among patients with HS, and is a risk factor for the disease in general, and for more severe and refractory disease, he added. Consequently, screening for tobacco smoking is recommended for patients with HS not only because of the impact on disease, but because it is a potentially modifiable cardiovascular risk factor, he explained.
Consider comorbidities
Cardiovascular disease is among several comorbidities associated with HS, said Dr. Micheletti. HS foundations in the United States and Canada recently published evidence-based recommendations for comorbidity screening. The recommendations included screening for 19 specific comorbidities: acne, dissecting cellulitis, pilonidal disease, pyoderma gangrenosum, depression, anxiety, suicide, smoking, substance abuse, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction.
Dr. Micheletti highlighted cardiovascular comorbidities, and noted the association between HS and modifiable cardiovascular risk factors: smoking, obesity, diabetes mellitus, and dyslipidemia. “HS is also independently associated with cardiovascular disease leading to myocardial infarction, stroke, cardiovascular-associated death, and all-cause mortality compared to controls,” he said. Studies show an incidence rate ratio of 1.53 for major adverse cardiovascular events in patients with HS compared with controls, with the highest relative risk among those aged 18-29 years, he added.
Medical management
Depending on the patient, medical management of HS may involve antibiotics, hormonal agents, and biologics, said Dr. Micheletti. Some of the most commonly used antibiotic regimens for HS are those recommended in treatment guidelines, including doxycycline and a clindamycin/rifampin combination, he said. However, the use of trimethoprim-sulfamethoxazole or ciprofloxacin has been associated with increased antibiotic resistance and is not supported by available evidence, he noted.
Hormonal therapies may help some women with HS, said Dr. Micheletti. Options include spironolactone, metformin, or estrogen-containing hormonal contraceptives, he said.
When it comes to biologics, only 33% of HS patients meet criteria for their use (Hurley stage II or III, moderate or severe HS), he noted. However, research suggests “a huge gap” in the use of anti-TNF therapy even among patients for whom it is recommended, he said.
Of the TNF-alpha inhibitors, data on adalimumab, which is FDA-approved for HS, are the most recent. Adalimumab “is our gold standard biologic and our gateway biologic, for HS at this time,” Dr. Micheletti said.
However, those who respond to adalimumab “can continue to do better, but they can wax and wane and flare,” he cautioned. Infliximab, while not approved for HS, has been studied in patients with HS and is prescribed by some providers. Although no comparative studies have been done for infliximab versus adalimumab, “anecdotally, response to infliximab tends to be better, and it is the most effective biologic in common use for severe HS,” he noted.
Dr. Micheletti’s top treatment recommendations for using biologics start with considering biosimilars. Most patients on biosimilars do fine, but some patients who previously responded to infliximab will unpredictably lose efficacy or have reactions when switched to a biosimilar, he said.
Patients on biologics also may experience waning efficacy in the wake of an immune response stimulated by foreign antibodies, said Dr. Micheletti. “Anti-drug antibody formation is more likely to occur when treatment is interrupted,” he noted. Minimize the risk of antibody formation by paying attention to adherence issues and dosing frequency, he advised.
If patients fail both adalimumab and infliximab, Dr. Micheletti tells them not to lose hope, and that treatment is a trial-and-error process that may involve more than one therapy. Other biologics in active use for HS include ustekinumab, anakinra, secukinumab, brodalumab, golimumab, and JAK inhibitors, any of which might be effective in any given patient, he said.
Surgical solutions
For HS patients with chronic, recurring inflammation and drainage associated with a sinus tract, surgical deroofing may the best treatment option, Dr. Micheletti said. “Deroofing involves the use of a probe to trace the extent of the subcutaneous tract, followed by incision and removal of the tract ‘roof,’ ’’ he explained. The deroofing procedure involves local anesthesia and has a low morbidity rate, as well as a low recurrence rate and high levels of patient satisfaction, he said.
“The acute role for surgery is to remove active foci of inflammation and relieve pain,” which is achieved more effectively with deroofing, said Dr. Micheletti. By contrast, incision and drainage is associated with an almost 100% recurrence rate, he added.
When planning elective surgery for HS, Dr. Micheletti noted that holding infliximab for less than 4 weeks does not affect postoperative infection rates in patients with rheumatoid arthritis, and a recent randomized, controlled trial showed that adalimumab can be continued safely through HS surgeries.
In fact, “continuing TNF inhibitors through elective surgery does not increase infection risk and results in better disease control,” and dermatologists should work with surgery to balance infection and disease flare concerns in HS patients, he said.
Dr. Micheletti disclosed serving as a consultant or advisor for Adaptimmune and Vertex, and research funding from Amgen and Cabaletta Bio. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – , Robert G. Micheletti, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
For patients with HS, “the quality-of-life impact is profound, greater than any other systematically studied dermatologic condition,” said Dr. Micheletti, associate professor of dermatology at the Hospital of the University of Pennsylavnia, and chief of hospital dermatology, and chief of dermatology at Pennsylvania Hospital, Philadelphia.
Two key aspects of quality of life that affect HS patients are sexual health and overall pain, he said. The female-to-male ratio of HS is approximately 3:1, and data show that approximately 40% of female HS patients experience fertility issues and have unaddressed questions about HS and pregnancy, said Dr. Micheletti. Additionally, data from a systematic review showed that 50%-60% of patients with HS reported sexual dysfunction. Impaired sexual function is also associated with both overall impaired quality of life ratings and the presence of mood disorders, he noted.
Pain also has a significant impact on quality of life for HS patients. When these patients present in an emergency department, 70% report severe pain, and approximately 60% receive opioids, said Dr. Micheletti.
Data from a 2021 study showed that HS patients are significantly more likely to receive opioids compared with controls, and also more likely to be diagnosed with opioid use disorder than controls, especially if they are seen by nondermatologists, he noted.
For acute pain, Dr. Micheletti recommended starting with acetaminophen 500 mg every 4 to 6 hours as needed, and topical nonsteroidal anti-inflammatory drugs (NSAIDs). “It still makes sense to do topical care,” said Dr. Micheletti, but he added that he also prescribes medications for anxiety for these patients.
Patients with increased pain severity or refractory disease may benefit from systemic NSAIDs, or intralesional triamcinolone, he noted. Incision and draining of abscesses may provide temporary symptomatic relief, but keep in mind that lesions will recur, he noted.
For the most severe cases, Dr. Micheletti advised adding tramadol as a first-line opioid, or another short-acting opioid for breakthrough pain.
To manage patients with HS who have chronic pain, Dr. Micheletti recommended starting with HS disease–directed therapy, but also screening for pain severity and psychological comorbidities.
His strategies in these cases include nonpharmacological pain management in the form of physical therapy, wound care, and behavioral health. His algorithm for nociceptive pain is NSAIDs with or without acetaminophen; duloxetine or nortriptyline are other options. For neuropathic pain, gabapentin and/or duloxetine are top choices, but pregabalin, venlafaxine, and nortriptyline are on the list as well.
Topical NSAIDs or topical lidocaine may serve as add-ons to systemic therapy in more severe cases, or as first-line therapy for milder chronic pain, Dr. Micheletti noted. Patients who have failed treatment with at least two pharmacologic agents, suffer medically refractory HS with debilitating pain, or use opioids on an ongoing basis should be referred to a pain management specialist, he said.
Don’t forget lifestyle
Although data on the impact of diet on patients with HS are limited, “we know anecdotally that dairy and refined carbohydrates are associated with exacerbations,” said Dr. Micheletti.
In addition, many patients use complementary medicine “and they aren’t always telling us,” he emphasized. Smoking is prevalent among patients with HS, and is a risk factor for the disease in general, and for more severe and refractory disease, he added. Consequently, screening for tobacco smoking is recommended for patients with HS not only because of the impact on disease, but because it is a potentially modifiable cardiovascular risk factor, he explained.
Consider comorbidities
Cardiovascular disease is among several comorbidities associated with HS, said Dr. Micheletti. HS foundations in the United States and Canada recently published evidence-based recommendations for comorbidity screening. The recommendations included screening for 19 specific comorbidities: acne, dissecting cellulitis, pilonidal disease, pyoderma gangrenosum, depression, anxiety, suicide, smoking, substance abuse, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction.
Dr. Micheletti highlighted cardiovascular comorbidities, and noted the association between HS and modifiable cardiovascular risk factors: smoking, obesity, diabetes mellitus, and dyslipidemia. “HS is also independently associated with cardiovascular disease leading to myocardial infarction, stroke, cardiovascular-associated death, and all-cause mortality compared to controls,” he said. Studies show an incidence rate ratio of 1.53 for major adverse cardiovascular events in patients with HS compared with controls, with the highest relative risk among those aged 18-29 years, he added.
Medical management
Depending on the patient, medical management of HS may involve antibiotics, hormonal agents, and biologics, said Dr. Micheletti. Some of the most commonly used antibiotic regimens for HS are those recommended in treatment guidelines, including doxycycline and a clindamycin/rifampin combination, he said. However, the use of trimethoprim-sulfamethoxazole or ciprofloxacin has been associated with increased antibiotic resistance and is not supported by available evidence, he noted.
Hormonal therapies may help some women with HS, said Dr. Micheletti. Options include spironolactone, metformin, or estrogen-containing hormonal contraceptives, he said.
When it comes to biologics, only 33% of HS patients meet criteria for their use (Hurley stage II or III, moderate or severe HS), he noted. However, research suggests “a huge gap” in the use of anti-TNF therapy even among patients for whom it is recommended, he said.
Of the TNF-alpha inhibitors, data on adalimumab, which is FDA-approved for HS, are the most recent. Adalimumab “is our gold standard biologic and our gateway biologic, for HS at this time,” Dr. Micheletti said.
However, those who respond to adalimumab “can continue to do better, but they can wax and wane and flare,” he cautioned. Infliximab, while not approved for HS, has been studied in patients with HS and is prescribed by some providers. Although no comparative studies have been done for infliximab versus adalimumab, “anecdotally, response to infliximab tends to be better, and it is the most effective biologic in common use for severe HS,” he noted.
Dr. Micheletti’s top treatment recommendations for using biologics start with considering biosimilars. Most patients on biosimilars do fine, but some patients who previously responded to infliximab will unpredictably lose efficacy or have reactions when switched to a biosimilar, he said.
Patients on biologics also may experience waning efficacy in the wake of an immune response stimulated by foreign antibodies, said Dr. Micheletti. “Anti-drug antibody formation is more likely to occur when treatment is interrupted,” he noted. Minimize the risk of antibody formation by paying attention to adherence issues and dosing frequency, he advised.
If patients fail both adalimumab and infliximab, Dr. Micheletti tells them not to lose hope, and that treatment is a trial-and-error process that may involve more than one therapy. Other biologics in active use for HS include ustekinumab, anakinra, secukinumab, brodalumab, golimumab, and JAK inhibitors, any of which might be effective in any given patient, he said.
Surgical solutions
For HS patients with chronic, recurring inflammation and drainage associated with a sinus tract, surgical deroofing may the best treatment option, Dr. Micheletti said. “Deroofing involves the use of a probe to trace the extent of the subcutaneous tract, followed by incision and removal of the tract ‘roof,’ ’’ he explained. The deroofing procedure involves local anesthesia and has a low morbidity rate, as well as a low recurrence rate and high levels of patient satisfaction, he said.
“The acute role for surgery is to remove active foci of inflammation and relieve pain,” which is achieved more effectively with deroofing, said Dr. Micheletti. By contrast, incision and drainage is associated with an almost 100% recurrence rate, he added.
When planning elective surgery for HS, Dr. Micheletti noted that holding infliximab for less than 4 weeks does not affect postoperative infection rates in patients with rheumatoid arthritis, and a recent randomized, controlled trial showed that adalimumab can be continued safely through HS surgeries.
In fact, “continuing TNF inhibitors through elective surgery does not increase infection risk and results in better disease control,” and dermatologists should work with surgery to balance infection and disease flare concerns in HS patients, he said.
Dr. Micheletti disclosed serving as a consultant or advisor for Adaptimmune and Vertex, and research funding from Amgen and Cabaletta Bio. MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – , Robert G. Micheletti, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
For patients with HS, “the quality-of-life impact is profound, greater than any other systematically studied dermatologic condition,” said Dr. Micheletti, associate professor of dermatology at the Hospital of the University of Pennsylavnia, and chief of hospital dermatology, and chief of dermatology at Pennsylvania Hospital, Philadelphia.
Two key aspects of quality of life that affect HS patients are sexual health and overall pain, he said. The female-to-male ratio of HS is approximately 3:1, and data show that approximately 40% of female HS patients experience fertility issues and have unaddressed questions about HS and pregnancy, said Dr. Micheletti. Additionally, data from a systematic review showed that 50%-60% of patients with HS reported sexual dysfunction. Impaired sexual function is also associated with both overall impaired quality of life ratings and the presence of mood disorders, he noted.
Pain also has a significant impact on quality of life for HS patients. When these patients present in an emergency department, 70% report severe pain, and approximately 60% receive opioids, said Dr. Micheletti.
Data from a 2021 study showed that HS patients are significantly more likely to receive opioids compared with controls, and also more likely to be diagnosed with opioid use disorder than controls, especially if they are seen by nondermatologists, he noted.
For acute pain, Dr. Micheletti recommended starting with acetaminophen 500 mg every 4 to 6 hours as needed, and topical nonsteroidal anti-inflammatory drugs (NSAIDs). “It still makes sense to do topical care,” said Dr. Micheletti, but he added that he also prescribes medications for anxiety for these patients.
Patients with increased pain severity or refractory disease may benefit from systemic NSAIDs, or intralesional triamcinolone, he noted. Incision and draining of abscesses may provide temporary symptomatic relief, but keep in mind that lesions will recur, he noted.
For the most severe cases, Dr. Micheletti advised adding tramadol as a first-line opioid, or another short-acting opioid for breakthrough pain.
To manage patients with HS who have chronic pain, Dr. Micheletti recommended starting with HS disease–directed therapy, but also screening for pain severity and psychological comorbidities.
His strategies in these cases include nonpharmacological pain management in the form of physical therapy, wound care, and behavioral health. His algorithm for nociceptive pain is NSAIDs with or without acetaminophen; duloxetine or nortriptyline are other options. For neuropathic pain, gabapentin and/or duloxetine are top choices, but pregabalin, venlafaxine, and nortriptyline are on the list as well.
Topical NSAIDs or topical lidocaine may serve as add-ons to systemic therapy in more severe cases, or as first-line therapy for milder chronic pain, Dr. Micheletti noted. Patients who have failed treatment with at least two pharmacologic agents, suffer medically refractory HS with debilitating pain, or use opioids on an ongoing basis should be referred to a pain management specialist, he said.
Don’t forget lifestyle
Although data on the impact of diet on patients with HS are limited, “we know anecdotally that dairy and refined carbohydrates are associated with exacerbations,” said Dr. Micheletti.
In addition, many patients use complementary medicine “and they aren’t always telling us,” he emphasized. Smoking is prevalent among patients with HS, and is a risk factor for the disease in general, and for more severe and refractory disease, he added. Consequently, screening for tobacco smoking is recommended for patients with HS not only because of the impact on disease, but because it is a potentially modifiable cardiovascular risk factor, he explained.
Consider comorbidities
Cardiovascular disease is among several comorbidities associated with HS, said Dr. Micheletti. HS foundations in the United States and Canada recently published evidence-based recommendations for comorbidity screening. The recommendations included screening for 19 specific comorbidities: acne, dissecting cellulitis, pilonidal disease, pyoderma gangrenosum, depression, anxiety, suicide, smoking, substance abuse, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction.
Dr. Micheletti highlighted cardiovascular comorbidities, and noted the association between HS and modifiable cardiovascular risk factors: smoking, obesity, diabetes mellitus, and dyslipidemia. “HS is also independently associated with cardiovascular disease leading to myocardial infarction, stroke, cardiovascular-associated death, and all-cause mortality compared to controls,” he said. Studies show an incidence rate ratio of 1.53 for major adverse cardiovascular events in patients with HS compared with controls, with the highest relative risk among those aged 18-29 years, he added.
Medical management
Depending on the patient, medical management of HS may involve antibiotics, hormonal agents, and biologics, said Dr. Micheletti. Some of the most commonly used antibiotic regimens for HS are those recommended in treatment guidelines, including doxycycline and a clindamycin/rifampin combination, he said. However, the use of trimethoprim-sulfamethoxazole or ciprofloxacin has been associated with increased antibiotic resistance and is not supported by available evidence, he noted.
Hormonal therapies may help some women with HS, said Dr. Micheletti. Options include spironolactone, metformin, or estrogen-containing hormonal contraceptives, he said.
When it comes to biologics, only 33% of HS patients meet criteria for their use (Hurley stage II or III, moderate or severe HS), he noted. However, research suggests “a huge gap” in the use of anti-TNF therapy even among patients for whom it is recommended, he said.
Of the TNF-alpha inhibitors, data on adalimumab, which is FDA-approved for HS, are the most recent. Adalimumab “is our gold standard biologic and our gateway biologic, for HS at this time,” Dr. Micheletti said.
However, those who respond to adalimumab “can continue to do better, but they can wax and wane and flare,” he cautioned. Infliximab, while not approved for HS, has been studied in patients with HS and is prescribed by some providers. Although no comparative studies have been done for infliximab versus adalimumab, “anecdotally, response to infliximab tends to be better, and it is the most effective biologic in common use for severe HS,” he noted.
Dr. Micheletti’s top treatment recommendations for using biologics start with considering biosimilars. Most patients on biosimilars do fine, but some patients who previously responded to infliximab will unpredictably lose efficacy or have reactions when switched to a biosimilar, he said.
Patients on biologics also may experience waning efficacy in the wake of an immune response stimulated by foreign antibodies, said Dr. Micheletti. “Anti-drug antibody formation is more likely to occur when treatment is interrupted,” he noted. Minimize the risk of antibody formation by paying attention to adherence issues and dosing frequency, he advised.
If patients fail both adalimumab and infliximab, Dr. Micheletti tells them not to lose hope, and that treatment is a trial-and-error process that may involve more than one therapy. Other biologics in active use for HS include ustekinumab, anakinra, secukinumab, brodalumab, golimumab, and JAK inhibitors, any of which might be effective in any given patient, he said.
Surgical solutions
For HS patients with chronic, recurring inflammation and drainage associated with a sinus tract, surgical deroofing may the best treatment option, Dr. Micheletti said. “Deroofing involves the use of a probe to trace the extent of the subcutaneous tract, followed by incision and removal of the tract ‘roof,’ ’’ he explained. The deroofing procedure involves local anesthesia and has a low morbidity rate, as well as a low recurrence rate and high levels of patient satisfaction, he said.
“The acute role for surgery is to remove active foci of inflammation and relieve pain,” which is achieved more effectively with deroofing, said Dr. Micheletti. By contrast, incision and drainage is associated with an almost 100% recurrence rate, he added.
When planning elective surgery for HS, Dr. Micheletti noted that holding infliximab for less than 4 weeks does not affect postoperative infection rates in patients with rheumatoid arthritis, and a recent randomized, controlled trial showed that adalimumab can be continued safely through HS surgeries.
In fact, “continuing TNF inhibitors through elective surgery does not increase infection risk and results in better disease control,” and dermatologists should work with surgery to balance infection and disease flare concerns in HS patients, he said.
Dr. Micheletti disclosed serving as a consultant or advisor for Adaptimmune and Vertex, and research funding from Amgen and Cabaletta Bio. MedscapeLive and this news organization are owned by the same parent company.
AT INNOVATIONS IN DERMATOLOGY
Flu, RSV infecting children at staggering rates
There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.
In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.
Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).
“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.
Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.
RSV rates are also stunningly high.
“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”
Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.
“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”
A version of this article first appeared on Medscape.com.
There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.
In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.
Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).
“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.
Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.
RSV rates are also stunningly high.
“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”
Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.
“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”
A version of this article first appeared on Medscape.com.
There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.
In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.
Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).
“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.
Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.
RSV rates are also stunningly high.
“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”
Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.
“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”
A version of this article first appeared on Medscape.com.
Women docs: How your next job contract can reflect your real goals
Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.
“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.
“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.
He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”
Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”
Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.
Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.
Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
It starts with the interview
“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.
He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.
Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
Know your worth and go for it
Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.
One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”
In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.
Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.
Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.
Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
Part-time vs. full-time
Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”
He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”
In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
Maternity leave: A tricky question
Many attorneys counsel against raising the question out of fear of scaring away potential employers.
“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.
“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”
Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”
The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.
“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”
Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”
Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.
“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
Do you want partnership?
Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.
Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.
On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
The impact of shift schedule
Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”
Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”
Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
Removing the ‘golden handcuffs’
Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”
Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.
“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”
She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.
Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”
Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”
Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”
It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.
A version of this article first appeared on Medscape.com.
Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.
“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.
“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.
He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”
Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”
Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.
Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.
Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
It starts with the interview
“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.
He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.
Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
Know your worth and go for it
Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.
One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”
In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.
Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.
Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.
Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
Part-time vs. full-time
Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”
He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”
In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
Maternity leave: A tricky question
Many attorneys counsel against raising the question out of fear of scaring away potential employers.
“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.
“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”
Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”
The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.
“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”
Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”
Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.
“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
Do you want partnership?
Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.
Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.
On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
The impact of shift schedule
Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”
Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”
Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
Removing the ‘golden handcuffs’
Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”
Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.
“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”
She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.
Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”
Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”
Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”
It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.
A version of this article first appeared on Medscape.com.
Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.
“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.
“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.
He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”
Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”
Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.
Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.
Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
It starts with the interview
“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.
He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.
Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
Know your worth and go for it
Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.
One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”
In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.
Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.
Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.
Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
Part-time vs. full-time
Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”
He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”
In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
Maternity leave: A tricky question
Many attorneys counsel against raising the question out of fear of scaring away potential employers.
“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.
“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”
Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”
The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.
“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”
Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”
Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.
“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
Do you want partnership?
Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.
Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.
On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
The impact of shift schedule
Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”
Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”
Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
Removing the ‘golden handcuffs’
Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”
Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.
“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”
She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.
Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”
Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”
Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”
It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.
A version of this article first appeared on Medscape.com.