Federal Practitioner

Visceral adipose tissue is significantly reduced with the green Mediterranean diet (MED), which consists of polyphenols and reduced red meat intake, according to a new analysis of the 18-month Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed (DIRECT-PLUS) trial.

The new results indicate that the green Mediterranean diet lowered visceral fat by twice as much as the standard Mediterranean diet (14% vs. 7%), reported Iris Shai, PhD, of Ben-Gurion University of the Negev in Be’er Sheva, Israel, and colleagues.

“This study may suggest an improved dietary protocol for treating visceral adiposity,” the authors wrote in their article, published recently in BMC Medicine.

“A healthy lifestyle is a strong basis for any weight-loss program. We learned from the results of our experiment that the quality of food is no less important than the number of calories consumed and the goal today is to understand the mechanisms of various nutrients, for example, positive ones such as the polyphenols, and negative ones such as empty carbohydrates and processed red meat, on the pace of fat cell differentiation and their aggregation in the viscera,” Dr. Shai said in a press release from Ben‐Gurion University.

“A 14% reduction in visceral fat is a dramatic achievement for making simple changes to your diet and lifestyle. Weight loss is an important goal only if it is accompanied by impressive results in reducing adipose tissue,” added coauthor Hila Zelicha, RD, PhD, also of Ben‐Gurion University of the Negev.

Previous randomized controlled trials have shown that dietary changes with a higher polyphenol content tend to produce better cardiometabolic outcomes and appear to mobilize particular ectopic fat depots, the researchers noted.

The main results of the DIRECT-PLUS trial were published in 2020 in Heart. Almost 300 participants with abdominal obesity/dyslipidemia were randomized to one of three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean diet, and the so-called green Mediterranean diet. The mean age of participants was 51 years, and men comprised 88% of the study cohort.

Participants in both Mediterranean diet groups ate 28 grams/day of walnuts, which accounted for about 440 mg/day of polyphenols. Participants in the green Mediterranean group also ate 100 grams/day of frozen cubes of a Wolffia globosa (duckweed strain) plant green shake, and three to four cups/day of green tea, which contributed to consumption of 800 mg/day of polyphenols, and decreased red meat consumption.

Both the green and standard Mediterranean diet groups achieved similar weight loss (–6.2 kg and –5.4 kg) compared with the HDG group (–1.5 kg; P < .001). However, the green Mediterranean diet group had a greater reduction in waist circumference (–8.6 cm) than the standard Mediterranean diet group (–6.8 cm; P = .033) and HDG group (–4.3 cm; P < .001). Stratification by gender showed these differences were significant only among men.

Explaining the rationale for the study, the researchers noted that visceral adipose tissue accumulation is a key factor that differentiates metabolic healthy and unhealthy obese individuals, is closely related to the development of multiple cardiovascular risk factors, including hypertension, dyslipidemia, and type 2 diabetes, and is an independent marker of mortality.

Now, their latest data show the green Mediterranean diet group lost approximately twice as much visceral adipose tissue compared with the standard Mediterranean diet and HDG groups (−14.1%, −6.0%, and − 4.2%; P < .05 independent of weight loss, sex, waist circumference, or age).

Lower red meat consumption, greater dietary consumption of walnuts, Wolffia globosa, and green tea, increased urine urolithin A polyphenol, and elevated total plasma polyphenols were significantly associated with greater visceral adipose tissue loss (P < .05, multivariate models).

“A green Mediterranean diet enriched with polyphenols and decreased red meat consumption might serve as an improved version of the Mediterranean diet for targeted VAT reduction. Future studies are needed to explore the exact mechanisms of specific polyphenol-rich foods on visceral adiposity,” the study authors concluded.

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

Visceral adipose tissue is significantly reduced with the green Mediterranean diet (MED), which consists of polyphenols and reduced red meat intake, according to a new analysis of the 18-month Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed (DIRECT-PLUS) trial.

The new results indicate that the green Mediterranean diet lowered visceral fat by twice as much as the standard Mediterranean diet (14% vs. 7%), reported Iris Shai, PhD, of Ben-Gurion University of the Negev in Be’er Sheva, Israel, and colleagues.

“This study may suggest an improved dietary protocol for treating visceral adiposity,” the authors wrote in their article, published recently in BMC Medicine.

“A healthy lifestyle is a strong basis for any weight-loss program. We learned from the results of our experiment that the quality of food is no less important than the number of calories consumed and the goal today is to understand the mechanisms of various nutrients, for example, positive ones such as the polyphenols, and negative ones such as empty carbohydrates and processed red meat, on the pace of fat cell differentiation and their aggregation in the viscera,” Dr. Shai said in a press release from Ben‐Gurion University.

“A 14% reduction in visceral fat is a dramatic achievement for making simple changes to your diet and lifestyle. Weight loss is an important goal only if it is accompanied by impressive results in reducing adipose tissue,” added coauthor Hila Zelicha, RD, PhD, also of Ben‐Gurion University of the Negev.

Previous randomized controlled trials have shown that dietary changes with a higher polyphenol content tend to produce better cardiometabolic outcomes and appear to mobilize particular ectopic fat depots, the researchers noted.

The main results of the DIRECT-PLUS trial were published in 2020 in Heart. Almost 300 participants with abdominal obesity/dyslipidemia were randomized to one of three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean diet, and the so-called green Mediterranean diet. The mean age of participants was 51 years, and men comprised 88% of the study cohort.

Participants in both Mediterranean diet groups ate 28 grams/day of walnuts, which accounted for about 440 mg/day of polyphenols. Participants in the green Mediterranean group also ate 100 grams/day of frozen cubes of a Wolffia globosa (duckweed strain) plant green shake, and three to four cups/day of green tea, which contributed to consumption of 800 mg/day of polyphenols, and decreased red meat consumption.

Both the green and standard Mediterranean diet groups achieved similar weight loss (–6.2 kg and –5.4 kg) compared with the HDG group (–1.5 kg; P < .001). However, the green Mediterranean diet group had a greater reduction in waist circumference (–8.6 cm) than the standard Mediterranean diet group (–6.8 cm; P = .033) and HDG group (–4.3 cm; P < .001). Stratification by gender showed these differences were significant only among men.

Explaining the rationale for the study, the researchers noted that visceral adipose tissue accumulation is a key factor that differentiates metabolic healthy and unhealthy obese individuals, is closely related to the development of multiple cardiovascular risk factors, including hypertension, dyslipidemia, and type 2 diabetes, and is an independent marker of mortality.

Now, their latest data show the green Mediterranean diet group lost approximately twice as much visceral adipose tissue compared with the standard Mediterranean diet and HDG groups (−14.1%, −6.0%, and − 4.2%; P < .05 independent of weight loss, sex, waist circumference, or age).

Lower red meat consumption, greater dietary consumption of walnuts, Wolffia globosa, and green tea, increased urine urolithin A polyphenol, and elevated total plasma polyphenols were significantly associated with greater visceral adipose tissue loss (P < .05, multivariate models).

“A green Mediterranean diet enriched with polyphenols and decreased red meat consumption might serve as an improved version of the Mediterranean diet for targeted VAT reduction. Future studies are needed to explore the exact mechanisms of specific polyphenol-rich foods on visceral adiposity,” the study authors concluded.

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

Visceral adipose tissue is significantly reduced with the green Mediterranean diet (MED), which consists of polyphenols and reduced red meat intake, according to a new analysis of the 18-month Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed (DIRECT-PLUS) trial.

The new results indicate that the green Mediterranean diet lowered visceral fat by twice as much as the standard Mediterranean diet (14% vs. 7%), reported Iris Shai, PhD, of Ben-Gurion University of the Negev in Be’er Sheva, Israel, and colleagues.

“This study may suggest an improved dietary protocol for treating visceral adiposity,” the authors wrote in their article, published recently in BMC Medicine.

“A healthy lifestyle is a strong basis for any weight-loss program. We learned from the results of our experiment that the quality of food is no less important than the number of calories consumed and the goal today is to understand the mechanisms of various nutrients, for example, positive ones such as the polyphenols, and negative ones such as empty carbohydrates and processed red meat, on the pace of fat cell differentiation and their aggregation in the viscera,” Dr. Shai said in a press release from Ben‐Gurion University.

“A 14% reduction in visceral fat is a dramatic achievement for making simple changes to your diet and lifestyle. Weight loss is an important goal only if it is accompanied by impressive results in reducing adipose tissue,” added coauthor Hila Zelicha, RD, PhD, also of Ben‐Gurion University of the Negev.

Previous randomized controlled trials have shown that dietary changes with a higher polyphenol content tend to produce better cardiometabolic outcomes and appear to mobilize particular ectopic fat depots, the researchers noted.

The main results of the DIRECT-PLUS trial were published in 2020 in Heart. Almost 300 participants with abdominal obesity/dyslipidemia were randomized to one of three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean diet, and the so-called green Mediterranean diet. The mean age of participants was 51 years, and men comprised 88% of the study cohort.

Participants in both Mediterranean diet groups ate 28 grams/day of walnuts, which accounted for about 440 mg/day of polyphenols. Participants in the green Mediterranean group also ate 100 grams/day of frozen cubes of a Wolffia globosa (duckweed strain) plant green shake, and three to four cups/day of green tea, which contributed to consumption of 800 mg/day of polyphenols, and decreased red meat consumption.

Both the green and standard Mediterranean diet groups achieved similar weight loss (–6.2 kg and –5.4 kg) compared with the HDG group (–1.5 kg; P < .001). However, the green Mediterranean diet group had a greater reduction in waist circumference (–8.6 cm) than the standard Mediterranean diet group (–6.8 cm; P = .033) and HDG group (–4.3 cm; P < .001). Stratification by gender showed these differences were significant only among men.

Explaining the rationale for the study, the researchers noted that visceral adipose tissue accumulation is a key factor that differentiates metabolic healthy and unhealthy obese individuals, is closely related to the development of multiple cardiovascular risk factors, including hypertension, dyslipidemia, and type 2 diabetes, and is an independent marker of mortality.

Now, their latest data show the green Mediterranean diet group lost approximately twice as much visceral adipose tissue compared with the standard Mediterranean diet and HDG groups (−14.1%, −6.0%, and − 4.2%; P < .05 independent of weight loss, sex, waist circumference, or age).

Lower red meat consumption, greater dietary consumption of walnuts, Wolffia globosa, and green tea, increased urine urolithin A polyphenol, and elevated total plasma polyphenols were significantly associated with greater visceral adipose tissue loss (P < .05, multivariate models).

“A green Mediterranean diet enriched with polyphenols and decreased red meat consumption might serve as an improved version of the Mediterranean diet for targeted VAT reduction. Future studies are needed to explore the exact mechanisms of specific polyphenol-rich foods on visceral adiposity,” the study authors concluded.

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

The offspring of mothers who sustain unintentional injuries during pregnancy appear to have a modest 33% increased risk of developing cerebral palsy (CP) – higher when injuries are more severe, multiple, or lead to delivery soon afterward, a Canadian birth cohort study found.

Such children may benefit from long-term monitoring for neurodevelpmental issues, wrote a group led by Asma Ahmed, MD, PhD, MPH, a pediatric epidemiologist at the Hospital for Sick Children Research Institute in Toronto in JAMA Pediatrics.

“We need to provide better support for babies whose mothers have been injured in pregnancy, especially after severe injuries,” Dr. Ahmed said in a press release. “As well, these findings suggest the need for early monitoring of babies’ development, regular check-ups, and longer-term neurodevelopmental assessments.” Future studies should directly measure injury severity and its possible link to CP.

Current guidelines, however, focus on monitoring fetal condition immediately after injury with little attention to its long-term effects.

In their findings from the population-based linkage study of 2,110,177 children born in Ontario’s public health system during 2002-2017 and followed to 2018 with a median follow-up of 8 years:

• A total of 81,281 fetuses were exposed in utero to unintentional maternal injury.
• Overall, 0.3% children were diagnosed with CP, and the mean CP incidence rates were 4.36 per 10,000 child-years for the exposed versus 2.93 for the unexposed.
• In those exposed, the hazard ratio was 1.33 (95% confidence interval, 1.18-1.50) after adjusting for maternal sociodemographic and clinical characteristics.
• Injuries resulting in hospitalization or delivery within 1 week were linked to higher adjusted hazard ratios of 2.18 (95% CI, 1.29-3.68) and 3.40 (95% CI, 1.93-6.00), respectively.
• Injuries most frequently resulted from transportation mishaps, falls, and being struck by a person or object. They were most commonly associated with age younger than 20 years, substance use disorder, residence in rural and under-resourced areas, and lower socioeconomic status.

The authors noted that complications after maternal injuries – which affect 6%-8% of pregnant women – include uterine rupture, preterm delivery, and placental abruption and are linked to fetal complications such as asphyxia. The association with an offspring’s neurodevelopment has been rarely investigated. One U.K. population study, however, suggested a link between vehicular crashes and higher CP risk in preterm infants.

A related editorial on the study noted that while CP affects about two to four children per 1,000 live births each year in high-income countries, the etiological causes of most cases remain unknown. “This large population-based cohort study ... should inspire more research into preventing and mitigating factors for maternal injuries and offspring CP development,” wrote Zeyan Liew, PhD, MPH, and Haoran Zhuo, MPH, of Yale University School of Public Health in New Haven, Conn.

This study was supported by Santé-Québec and ICES, a research institute funded by the Ontario Ministry of Health and the Ministry of Long-Term Care.

Dr. Ahmed and coauthor Seungmi Yang, PhD, reported research funding from Santé-Québec during the conduct of the study.

The offspring of mothers who sustain unintentional injuries during pregnancy appear to have a modest 33% increased risk of developing cerebral palsy (CP) – higher when injuries are more severe, multiple, or lead to delivery soon afterward, a Canadian birth cohort study found.

Such children may benefit from long-term monitoring for neurodevelpmental issues, wrote a group led by Asma Ahmed, MD, PhD, MPH, a pediatric epidemiologist at the Hospital for Sick Children Research Institute in Toronto in JAMA Pediatrics.

“We need to provide better support for babies whose mothers have been injured in pregnancy, especially after severe injuries,” Dr. Ahmed said in a press release. “As well, these findings suggest the need for early monitoring of babies’ development, regular check-ups, and longer-term neurodevelopmental assessments.” Future studies should directly measure injury severity and its possible link to CP.

Current guidelines, however, focus on monitoring fetal condition immediately after injury with little attention to its long-term effects.

In their findings from the population-based linkage study of 2,110,177 children born in Ontario’s public health system during 2002-2017 and followed to 2018 with a median follow-up of 8 years:

• A total of 81,281 fetuses were exposed in utero to unintentional maternal injury.
• Overall, 0.3% children were diagnosed with CP, and the mean CP incidence rates were 4.36 per 10,000 child-years for the exposed versus 2.93 for the unexposed.
• In those exposed, the hazard ratio was 1.33 (95% confidence interval, 1.18-1.50) after adjusting for maternal sociodemographic and clinical characteristics.
• Injuries resulting in hospitalization or delivery within 1 week were linked to higher adjusted hazard ratios of 2.18 (95% CI, 1.29-3.68) and 3.40 (95% CI, 1.93-6.00), respectively.
• Injuries most frequently resulted from transportation mishaps, falls, and being struck by a person or object. They were most commonly associated with age younger than 20 years, substance use disorder, residence in rural and under-resourced areas, and lower socioeconomic status.

The authors noted that complications after maternal injuries – which affect 6%-8% of pregnant women – include uterine rupture, preterm delivery, and placental abruption and are linked to fetal complications such as asphyxia. The association with an offspring’s neurodevelopment has been rarely investigated. One U.K. population study, however, suggested a link between vehicular crashes and higher CP risk in preterm infants.

A related editorial on the study noted that while CP affects about two to four children per 1,000 live births each year in high-income countries, the etiological causes of most cases remain unknown. “This large population-based cohort study ... should inspire more research into preventing and mitigating factors for maternal injuries and offspring CP development,” wrote Zeyan Liew, PhD, MPH, and Haoran Zhuo, MPH, of Yale University School of Public Health in New Haven, Conn.

This study was supported by Santé-Québec and ICES, a research institute funded by the Ontario Ministry of Health and the Ministry of Long-Term Care.

Dr. Ahmed and coauthor Seungmi Yang, PhD, reported research funding from Santé-Québec during the conduct of the study.

The offspring of mothers who sustain unintentional injuries during pregnancy appear to have a modest 33% increased risk of developing cerebral palsy (CP) – higher when injuries are more severe, multiple, or lead to delivery soon afterward, a Canadian birth cohort study found.

Such children may benefit from long-term monitoring for neurodevelpmental issues, wrote a group led by Asma Ahmed, MD, PhD, MPH, a pediatric epidemiologist at the Hospital for Sick Children Research Institute in Toronto in JAMA Pediatrics.

“We need to provide better support for babies whose mothers have been injured in pregnancy, especially after severe injuries,” Dr. Ahmed said in a press release. “As well, these findings suggest the need for early monitoring of babies’ development, regular check-ups, and longer-term neurodevelopmental assessments.” Future studies should directly measure injury severity and its possible link to CP.

Current guidelines, however, focus on monitoring fetal condition immediately after injury with little attention to its long-term effects.

In their findings from the population-based linkage study of 2,110,177 children born in Ontario’s public health system during 2002-2017 and followed to 2018 with a median follow-up of 8 years:

• A total of 81,281 fetuses were exposed in utero to unintentional maternal injury.
• Overall, 0.3% children were diagnosed with CP, and the mean CP incidence rates were 4.36 per 10,000 child-years for the exposed versus 2.93 for the unexposed.
• In those exposed, the hazard ratio was 1.33 (95% confidence interval, 1.18-1.50) after adjusting for maternal sociodemographic and clinical characteristics.
• Injuries resulting in hospitalization or delivery within 1 week were linked to higher adjusted hazard ratios of 2.18 (95% CI, 1.29-3.68) and 3.40 (95% CI, 1.93-6.00), respectively.
• Injuries most frequently resulted from transportation mishaps, falls, and being struck by a person or object. They were most commonly associated with age younger than 20 years, substance use disorder, residence in rural and under-resourced areas, and lower socioeconomic status.

The authors noted that complications after maternal injuries – which affect 6%-8% of pregnant women – include uterine rupture, preterm delivery, and placental abruption and are linked to fetal complications such as asphyxia. The association with an offspring’s neurodevelopment has been rarely investigated. One U.K. population study, however, suggested a link between vehicular crashes and higher CP risk in preterm infants.

A related editorial on the study noted that while CP affects about two to four children per 1,000 live births each year in high-income countries, the etiological causes of most cases remain unknown. “This large population-based cohort study ... should inspire more research into preventing and mitigating factors for maternal injuries and offspring CP development,” wrote Zeyan Liew, PhD, MPH, and Haoran Zhuo, MPH, of Yale University School of Public Health in New Haven, Conn.

This study was supported by Santé-Québec and ICES, a research institute funded by the Ontario Ministry of Health and the Ministry of Long-Term Care.

Dr. Ahmed and coauthor Seungmi Yang, PhD, reported research funding from Santé-Québec during the conduct of the study.

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

An online yoga program appears to be effective, feasible, and safe for patients with irritable bowel syndrome (IBS), according to a new report.

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.

An online yoga program appears to be effective, feasible, and safe for patients with irritable bowel syndrome (IBS), according to a new report.

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.

An online yoga program appears to be effective, feasible, and safe for patients with irritable bowel syndrome (IBS), according to a new report.

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.

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.

The early stages of the COVID-19 pandemic caused an average treatment delay of 3.2 months for 53% of patients with cutaneous T-cell lymphoma (CTCL), results from a retrospective study of nine international centers showed. However, among patients with CTCL diagnosed with COVID-19 during that time, no cases were acquired from outpatient visits.

“Delays in therapy for patients with cutaneous lymphomas should likely be avoided,” two of the study authors, Larisa J. Geskin, MD, of the department of dermatology at Columbia University Irving Medical Center, New York, and Bradley D. Kwinta, a medical student at Columbia University, told this news organization in a combined response via email.

“Continuing treatment and maintenance therapy appears critical to avoiding disease progression, highlighting the importance of maintenance therapy in CTCL,” they said. “These patients can be safely treated according to established treatment protocols while practicing physical distancing and using personal protective equipment without significantly increasing their risk of COVID-19 infection.”

The United States Cutaneous Lymphoma Consortium and the European Organization for Research and Treatment of Cancer developed emergency guidelines for the management of patients with cutaneous lymphomas during the pandemic to ensure patient safety, and the International Society for Cutaneous Lymphomas created an International Cutaneous Lymphomas Pandemic Section to collect data to assess the impact of these guidelines.

“Using this data, we can determine if these measures were effective in preventing COVID-19 infection, what the impact was of maintenance therapy, and how delays in treatment affected disease outcomes in CTCL patients,” the authors and their colleagues wrote in the study, which was published in the Journal of the American Academy of Dermatology.

They retrospectively analyzed data from the electronic medical records of 149 patients with CTCL who were being managed at one of nine international academic medical centers in seven countries from March to October 2020. Slightly more than half (56%) were male, 70% were White, 18% were Black, 52% had stage IA-IIA disease, and 19% acquired COVID-19 during the study period.

Of the 149 patients, 79 (53%) experienced a mean treatment delay of 3.2 months (range, 10 days to 10 months). After adjusting for age, race, biological sex, COVID-19 status, and disease stage, treatment delay was associated with a significant risk of disease relapse or progression across all stages (odds ratio, 5.00; P < .001). Specifically, for each additional month that a patient experienced treatment delay, the odds of disease progression increased by 37% (OR, 1.37; P < .001).

A total of 28 patients with CTCL (19%) were diagnosed with COVID-19, but none were acquired from outpatient office visits. Patients who contracted COVID-19 did not have a statistically significant increase in odds of disease progression, compared with COVID-negative patients (OR, 0.41; P = .07).

According to Dr. Geskin, who is also director of the Comprehensive Skin Cancer Center in the division of cutaneous oncology in the department of dermatology at Columbia, and Mr. Kwinta, no clinical trials exist to inform maintenance protocols in patients with cutaneous lymphomas. “There are also no randomized and controlled observational studies that demonstrate the impact that therapy delay may have on disease outcomes,” they said in the email. “In fact, the need for maintenance therapy for CTCL is often debated. Our findings demonstrate the importance of continuing treatment and the use of maintenance therapy in avoiding disease progression in these incurable lymphomas.”

They acknowledged certain limitations of the study, including its retrospective observational design. “Therefore, we cannot establish a definitive causal link between treatment delay and disease progression,” they said. “Our cohort of patients were on various and often multiple therapies, making it hard to extrapolate our data to discern which maintenance therapies were most effective in preventing disease progression.”

In addition, their data only includes patients from March to October 2020, “before the discovery of new variants and the development of COVID-19 vaccines,” they added. “Additional studies would be required to draw conclusions on how COVID-19 vaccines may affect patients with CTCL, including outcomes in the setting of new variants.”

The authors reported having no financial disclosures.

The early stages of the COVID-19 pandemic caused an average treatment delay of 3.2 months for 53% of patients with cutaneous T-cell lymphoma (CTCL), results from a retrospective study of nine international centers showed. However, among patients with CTCL diagnosed with COVID-19 during that time, no cases were acquired from outpatient visits.

“Delays in therapy for patients with cutaneous lymphomas should likely be avoided,” two of the study authors, Larisa J. Geskin, MD, of the department of dermatology at Columbia University Irving Medical Center, New York, and Bradley D. Kwinta, a medical student at Columbia University, told this news organization in a combined response via email.

“Continuing treatment and maintenance therapy appears critical to avoiding disease progression, highlighting the importance of maintenance therapy in CTCL,” they said. “These patients can be safely treated according to established treatment protocols while practicing physical distancing and using personal protective equipment without significantly increasing their risk of COVID-19 infection.”

The United States Cutaneous Lymphoma Consortium and the European Organization for Research and Treatment of Cancer developed emergency guidelines for the management of patients with cutaneous lymphomas during the pandemic to ensure patient safety, and the International Society for Cutaneous Lymphomas created an International Cutaneous Lymphomas Pandemic Section to collect data to assess the impact of these guidelines.

“Using this data, we can determine if these measures were effective in preventing COVID-19 infection, what the impact was of maintenance therapy, and how delays in treatment affected disease outcomes in CTCL patients,” the authors and their colleagues wrote in the study, which was published in the Journal of the American Academy of Dermatology.

They retrospectively analyzed data from the electronic medical records of 149 patients with CTCL who were being managed at one of nine international academic medical centers in seven countries from March to October 2020. Slightly more than half (56%) were male, 70% were White, 18% were Black, 52% had stage IA-IIA disease, and 19% acquired COVID-19 during the study period.

Of the 149 patients, 79 (53%) experienced a mean treatment delay of 3.2 months (range, 10 days to 10 months). After adjusting for age, race, biological sex, COVID-19 status, and disease stage, treatment delay was associated with a significant risk of disease relapse or progression across all stages (odds ratio, 5.00; P < .001). Specifically, for each additional month that a patient experienced treatment delay, the odds of disease progression increased by 37% (OR, 1.37; P < .001).

A total of 28 patients with CTCL (19%) were diagnosed with COVID-19, but none were acquired from outpatient office visits. Patients who contracted COVID-19 did not have a statistically significant increase in odds of disease progression, compared with COVID-negative patients (OR, 0.41; P = .07).

According to Dr. Geskin, who is also director of the Comprehensive Skin Cancer Center in the division of cutaneous oncology in the department of dermatology at Columbia, and Mr. Kwinta, no clinical trials exist to inform maintenance protocols in patients with cutaneous lymphomas. “There are also no randomized and controlled observational studies that demonstrate the impact that therapy delay may have on disease outcomes,” they said in the email. “In fact, the need for maintenance therapy for CTCL is often debated. Our findings demonstrate the importance of continuing treatment and the use of maintenance therapy in avoiding disease progression in these incurable lymphomas.”

They acknowledged certain limitations of the study, including its retrospective observational design. “Therefore, we cannot establish a definitive causal link between treatment delay and disease progression,” they said. “Our cohort of patients were on various and often multiple therapies, making it hard to extrapolate our data to discern which maintenance therapies were most effective in preventing disease progression.”

In addition, their data only includes patients from March to October 2020, “before the discovery of new variants and the development of COVID-19 vaccines,” they added. “Additional studies would be required to draw conclusions on how COVID-19 vaccines may affect patients with CTCL, including outcomes in the setting of new variants.”

The authors reported having no financial disclosures.

The early stages of the COVID-19 pandemic caused an average treatment delay of 3.2 months for 53% of patients with cutaneous T-cell lymphoma (CTCL), results from a retrospective study of nine international centers showed. However, among patients with CTCL diagnosed with COVID-19 during that time, no cases were acquired from outpatient visits.

“Delays in therapy for patients with cutaneous lymphomas should likely be avoided,” two of the study authors, Larisa J. Geskin, MD, of the department of dermatology at Columbia University Irving Medical Center, New York, and Bradley D. Kwinta, a medical student at Columbia University, told this news organization in a combined response via email.

“Continuing treatment and maintenance therapy appears critical to avoiding disease progression, highlighting the importance of maintenance therapy in CTCL,” they said. “These patients can be safely treated according to established treatment protocols while practicing physical distancing and using personal protective equipment without significantly increasing their risk of COVID-19 infection.”

The United States Cutaneous Lymphoma Consortium and the European Organization for Research and Treatment of Cancer developed emergency guidelines for the management of patients with cutaneous lymphomas during the pandemic to ensure patient safety, and the International Society for Cutaneous Lymphomas created an International Cutaneous Lymphomas Pandemic Section to collect data to assess the impact of these guidelines.

“Using this data, we can determine if these measures were effective in preventing COVID-19 infection, what the impact was of maintenance therapy, and how delays in treatment affected disease outcomes in CTCL patients,” the authors and their colleagues wrote in the study, which was published in the Journal of the American Academy of Dermatology.

They retrospectively analyzed data from the electronic medical records of 149 patients with CTCL who were being managed at one of nine international academic medical centers in seven countries from March to October 2020. Slightly more than half (56%) were male, 70% were White, 18% were Black, 52% had stage IA-IIA disease, and 19% acquired COVID-19 during the study period.

Of the 149 patients, 79 (53%) experienced a mean treatment delay of 3.2 months (range, 10 days to 10 months). After adjusting for age, race, biological sex, COVID-19 status, and disease stage, treatment delay was associated with a significant risk of disease relapse or progression across all stages (odds ratio, 5.00; P < .001). Specifically, for each additional month that a patient experienced treatment delay, the odds of disease progression increased by 37% (OR, 1.37; P < .001).

A total of 28 patients with CTCL (19%) were diagnosed with COVID-19, but none were acquired from outpatient office visits. Patients who contracted COVID-19 did not have a statistically significant increase in odds of disease progression, compared with COVID-negative patients (OR, 0.41; P = .07).

According to Dr. Geskin, who is also director of the Comprehensive Skin Cancer Center in the division of cutaneous oncology in the department of dermatology at Columbia, and Mr. Kwinta, no clinical trials exist to inform maintenance protocols in patients with cutaneous lymphomas. “There are also no randomized and controlled observational studies that demonstrate the impact that therapy delay may have on disease outcomes,” they said in the email. “In fact, the need for maintenance therapy for CTCL is often debated. Our findings demonstrate the importance of continuing treatment and the use of maintenance therapy in avoiding disease progression in these incurable lymphomas.”

They acknowledged certain limitations of the study, including its retrospective observational design. “Therefore, we cannot establish a definitive causal link between treatment delay and disease progression,” they said. “Our cohort of patients were on various and often multiple therapies, making it hard to extrapolate our data to discern which maintenance therapies were most effective in preventing disease progression.”

In addition, their data only includes patients from March to October 2020, “before the discovery of new variants and the development of COVID-19 vaccines,” they added. “Additional studies would be required to draw conclusions on how COVID-19 vaccines may affect patients with CTCL, including outcomes in the setting of new variants.”

The authors reported having no financial disclosures.

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

• On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. 1 On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. 2 We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper 1 while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

A profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

• Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

• The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

• On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. 1 On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. 2 We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper 1 while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

A profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

• Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

• The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

• On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. 1 On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. 2 We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper 1 while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

A profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

• Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

• The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

Individuals with a primary melanoma may be more likely to develop a second primary melanoma if they have certain characteristics, a new study suggests.

In a cohort study of more than 38,000 patients, those diagnosed with a second primary melanoma were significantly more likely to have a “nevus-prone” phenotype and a high polygenic risk score for melanoma.

Notably, the researchers also found only limited evidence that elevated levels of sun exposure contributed to second melanoma risk.

Overall, the findings suggest that “within the general population, the presence of many nevi and having a high genetic predisposition to melanoma were associated with the highest risks of developing second primary melanoma,” Catherine M. Olsen, PhD, of the University of Queensland, Australia, and colleagues concluded.

The study was published online in JAMA Dermatology.

People with melanoma are believed to be at high risk for developing subsequent tumors, yet most never do. Population-based studies indicate that only about 8%-18% of patients are diagnosed with a second primary melanoma.

Previous studies using modified case-control design have identified several factors associated with developing multiple primary melanomas, including older age, male sex, a family history of melanoma, high nevus counts or presence of atypical nevi, higher ambient UV radiation and personal sun exposure, as well as certain inherited genetic variants.

However, these studies aren’t equipped to assess the magnitude of risk of developing multiple melanomas among those who have not yet had melanoma.

In the current analysis, Dr. Olsen and colleagues set out to understand the level of risk using a prospective cohort study design. The cohort comprised participants in the QSkin Sun and Health Study and included 38,845 patients with a baseline median age of 56 years, followed for a median of 7.4 years. Among these participants, 1,212 (3.1%) had only one primary melanoma diagnosis, and 245 (0.6%) had two or more primary melanomas. Of those with more primary melanomas, 59 had synchronous primary melanoma, meaning first and second primary melanomas were diagnosed on the same day.

The investigators compared the clinical characteristics of patients with first and second melanomas, looking at demographic, phenotypic, sun exposure, and genetic factors. The team found that the median time between first and second melanoma, excluding cases of synchronous primary melanoma, was 18.4 months.

Those who developed second melanomas were older at baseline than those who developed only one (59.3 years vs. 58.2 years, respectively; P < .001), and were more likely to have a sun-sensitive phenotype, a self-reported history of excisions for nonmelanoma skin cancers, and a high polygenic risk score for melanoma. Among people who developed second primary melanomas, the second melanomas were more likely to be in situ and of the lentigo maligna subtype.

Notably, factors including age, sex, sunburn tendency, and family history of melanoma had similarly elevated effect sizes among those diagnosed with first and second melanomas. The authors also found similar associations with baseline measures for personal sun exposure – including sunburns and cumulative sun exposure; however, the number of past skin cancer excisions was more strongly associated with second primaries (P = .05).

The team did identify two factors associated with a higher risk of developing a second primary melanoma. A nevus phenotype was more strongly associated with developing a second primary melanoma (hazard ratio, 6.36) than the initial one (HR, 3.46). And second primary melanomas had stronger associations with high melanoma polygenic risk scores than first primary melanomas (HR, 3.28 vs HR, 2.06; P = .03).

The authors noted several limitations to the study, including the generalizability of the findings outside of Australia and the relatively small number of people with second primary melanomas.

Still, the investigators note that the data “offer unique insights that differ from earlier efforts.” Namely, the “findings showed that many of the classic phenotypic risk factors for melanoma were similarly associated with risk of first and second melanomas; however, high numbers of nevi and high genetic predisposition were more strongly associated with second [rather] than first primary melanomas.”

This work was supported by grants from the National Health and Medical Research Council of Australia. Dr. Olsen reports no relevant financial relationships. Coauthor Rachel Neale, PhD, reported grants from Viatris and the National Health and Medical Research Council of Australia outside the submitted work. Coauthor David Whiteman, MBBS, PhD, reported personal fees from Pierre Fabre (speaker fees for conference presentation) outside the submitted work. No other disclosures were reported.

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

Individuals with a primary melanoma may be more likely to develop a second primary melanoma if they have certain characteristics, a new study suggests.

In a cohort study of more than 38,000 patients, those diagnosed with a second primary melanoma were significantly more likely to have a “nevus-prone” phenotype and a high polygenic risk score for melanoma.

Notably, the researchers also found only limited evidence that elevated levels of sun exposure contributed to second melanoma risk.

Overall, the findings suggest that “within the general population, the presence of many nevi and having a high genetic predisposition to melanoma were associated with the highest risks of developing second primary melanoma,” Catherine M. Olsen, PhD, of the University of Queensland, Australia, and colleagues concluded.

The study was published online in JAMA Dermatology.

People with melanoma are believed to be at high risk for developing subsequent tumors, yet most never do. Population-based studies indicate that only about 8%-18% of patients are diagnosed with a second primary melanoma.

Previous studies using modified case-control design have identified several factors associated with developing multiple primary melanomas, including older age, male sex, a family history of melanoma, high nevus counts or presence of atypical nevi, higher ambient UV radiation and personal sun exposure, as well as certain inherited genetic variants.

However, these studies aren’t equipped to assess the magnitude of risk of developing multiple melanomas among those who have not yet had melanoma.

In the current analysis, Dr. Olsen and colleagues set out to understand the level of risk using a prospective cohort study design. The cohort comprised participants in the QSkin Sun and Health Study and included 38,845 patients with a baseline median age of 56 years, followed for a median of 7.4 years. Among these participants, 1,212 (3.1%) had only one primary melanoma diagnosis, and 245 (0.6%) had two or more primary melanomas. Of those with more primary melanomas, 59 had synchronous primary melanoma, meaning first and second primary melanomas were diagnosed on the same day.

The investigators compared the clinical characteristics of patients with first and second melanomas, looking at demographic, phenotypic, sun exposure, and genetic factors. The team found that the median time between first and second melanoma, excluding cases of synchronous primary melanoma, was 18.4 months.

Those who developed second melanomas were older at baseline than those who developed only one (59.3 years vs. 58.2 years, respectively; P < .001), and were more likely to have a sun-sensitive phenotype, a self-reported history of excisions for nonmelanoma skin cancers, and a high polygenic risk score for melanoma. Among people who developed second primary melanomas, the second melanomas were more likely to be in situ and of the lentigo maligna subtype.

Notably, factors including age, sex, sunburn tendency, and family history of melanoma had similarly elevated effect sizes among those diagnosed with first and second melanomas. The authors also found similar associations with baseline measures for personal sun exposure – including sunburns and cumulative sun exposure; however, the number of past skin cancer excisions was more strongly associated with second primaries (P = .05).

The team did identify two factors associated with a higher risk of developing a second primary melanoma. A nevus phenotype was more strongly associated with developing a second primary melanoma (hazard ratio, 6.36) than the initial one (HR, 3.46). And second primary melanomas had stronger associations with high melanoma polygenic risk scores than first primary melanomas (HR, 3.28 vs HR, 2.06; P = .03).

The authors noted several limitations to the study, including the generalizability of the findings outside of Australia and the relatively small number of people with second primary melanomas.

Still, the investigators note that the data “offer unique insights that differ from earlier efforts.” Namely, the “findings showed that many of the classic phenotypic risk factors for melanoma were similarly associated with risk of first and second melanomas; however, high numbers of nevi and high genetic predisposition were more strongly associated with second [rather] than first primary melanomas.”

This work was supported by grants from the National Health and Medical Research Council of Australia. Dr. Olsen reports no relevant financial relationships. Coauthor Rachel Neale, PhD, reported grants from Viatris and the National Health and Medical Research Council of Australia outside the submitted work. Coauthor David Whiteman, MBBS, PhD, reported personal fees from Pierre Fabre (speaker fees for conference presentation) outside the submitted work. No other disclosures were reported.

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

Individuals with a primary melanoma may be more likely to develop a second primary melanoma if they have certain characteristics, a new study suggests.

In a cohort study of more than 38,000 patients, those diagnosed with a second primary melanoma were significantly more likely to have a “nevus-prone” phenotype and a high polygenic risk score for melanoma.

Notably, the researchers also found only limited evidence that elevated levels of sun exposure contributed to second melanoma risk.

Overall, the findings suggest that “within the general population, the presence of many nevi and having a high genetic predisposition to melanoma were associated with the highest risks of developing second primary melanoma,” Catherine M. Olsen, PhD, of the University of Queensland, Australia, and colleagues concluded.

The study was published online in JAMA Dermatology.

People with melanoma are believed to be at high risk for developing subsequent tumors, yet most never do. Population-based studies indicate that only about 8%-18% of patients are diagnosed with a second primary melanoma.

Previous studies using modified case-control design have identified several factors associated with developing multiple primary melanomas, including older age, male sex, a family history of melanoma, high nevus counts or presence of atypical nevi, higher ambient UV radiation and personal sun exposure, as well as certain inherited genetic variants.

However, these studies aren’t equipped to assess the magnitude of risk of developing multiple melanomas among those who have not yet had melanoma.

In the current analysis, Dr. Olsen and colleagues set out to understand the level of risk using a prospective cohort study design. The cohort comprised participants in the QSkin Sun and Health Study and included 38,845 patients with a baseline median age of 56 years, followed for a median of 7.4 years. Among these participants, 1,212 (3.1%) had only one primary melanoma diagnosis, and 245 (0.6%) had two or more primary melanomas. Of those with more primary melanomas, 59 had synchronous primary melanoma, meaning first and second primary melanomas were diagnosed on the same day.

The investigators compared the clinical characteristics of patients with first and second melanomas, looking at demographic, phenotypic, sun exposure, and genetic factors. The team found that the median time between first and second melanoma, excluding cases of synchronous primary melanoma, was 18.4 months.

Those who developed second melanomas were older at baseline than those who developed only one (59.3 years vs. 58.2 years, respectively; P < .001), and were more likely to have a sun-sensitive phenotype, a self-reported history of excisions for nonmelanoma skin cancers, and a high polygenic risk score for melanoma. Among people who developed second primary melanomas, the second melanomas were more likely to be in situ and of the lentigo maligna subtype.

Notably, factors including age, sex, sunburn tendency, and family history of melanoma had similarly elevated effect sizes among those diagnosed with first and second melanomas. The authors also found similar associations with baseline measures for personal sun exposure – including sunburns and cumulative sun exposure; however, the number of past skin cancer excisions was more strongly associated with second primaries (P = .05).

The team did identify two factors associated with a higher risk of developing a second primary melanoma. A nevus phenotype was more strongly associated with developing a second primary melanoma (hazard ratio, 6.36) than the initial one (HR, 3.46). And second primary melanomas had stronger associations with high melanoma polygenic risk scores than first primary melanomas (HR, 3.28 vs HR, 2.06; P = .03).

The authors noted several limitations to the study, including the generalizability of the findings outside of Australia and the relatively small number of people with second primary melanomas.

Still, the investigators note that the data “offer unique insights that differ from earlier efforts.” Namely, the “findings showed that many of the classic phenotypic risk factors for melanoma were similarly associated with risk of first and second melanomas; however, high numbers of nevi and high genetic predisposition were more strongly associated with second [rather] than first primary melanomas.”

This work was supported by grants from the National Health and Medical Research Council of Australia. Dr. Olsen reports no relevant financial relationships. Coauthor Rachel Neale, PhD, reported grants from Viatris and the National Health and Medical Research Council of Australia outside the submitted work. Coauthor David Whiteman, MBBS, PhD, reported personal fees from Pierre Fabre (speaker fees for conference presentation) outside the submitted work. No other disclosures were reported.

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

Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.

According to the Medscape “Right and Wrong in Medicine: Life, Death, and Wrenching Choices” report, how you handle the informed consent process can be the difference between a positive outcome and a negative one.

“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.

In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.

“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”

That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.

“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”

Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.

How long an informed consent discussion takes depends on the procedure.

“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.

Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.

She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.

When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.

“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
 

Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”

It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.

In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
 

What happens when things go wrong?

If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.

“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”

Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.

Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.

“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”

To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.

“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”

For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.

Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.

“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”

In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.

“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”

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

Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.

According to the Medscape “Right and Wrong in Medicine: Life, Death, and Wrenching Choices” report, how you handle the informed consent process can be the difference between a positive outcome and a negative one.

“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.

In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.

“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”

That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.

“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”

Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.

How long an informed consent discussion takes depends on the procedure.

“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.

Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.

She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.

When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.

“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
 

Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”

It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.

In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
 

What happens when things go wrong?

If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.

“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”

Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.

Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.

“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”

To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.

“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”

For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.

Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.

“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”

In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.

“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”

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

Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.

According to the Medscape “Right and Wrong in Medicine: Life, Death, and Wrenching Choices” report, how you handle the informed consent process can be the difference between a positive outcome and a negative one.

“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.

In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.

“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”

That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.

“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”

Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.

How long an informed consent discussion takes depends on the procedure.

“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.

Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.

She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.

When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.

“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
 

Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”

It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.

In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
 

What happens when things go wrong?

If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.

“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”

Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.

Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.

“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”

To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.

“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”

For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.

Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.

“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”

In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.

“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”

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