PHILADELPHIA – Treatment with the interleukin-6 receptor antagonist sarilumab (Kevzara), along with a 14-week taper of glucocorticoids, proved to have significant efficacy in patients with relapsing polymyalgia rheumatica (PMR) who were resistant to glucocorticoids in a phase 3 trial.

No new safety concerns were found with sarilumab in the multicenter, randomized, double-blind, placebo-controlled SAPHYR trial. Sarilumab is approved in the United States for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.

The results, presented at the annual meeting of the American College of Rheumatology by Robert Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery in New York, included clinically meaningful improvement in quality-of-life scores.

The disease, which primarily affects people over age 65, can cause widespread aching and stiffness. It’s one of the most common inflammatory diseases among older adults.

PMR is relatively easy to treat with glucocorticoids, but relapses are common, which means long courses of glucocorticoid therapy and the side effects that come with them.
 

Need for a steroid-sparing therapy

“We recognize that a steroid-sparing drug in polymyalgia rheumatica seems to be an unmet need,” Dr. Spiera said at the meeting.

The trial, sponsored by Sanofi, included active, refractory PMR patients who flared within 3 months of study entry while on at least 7.5 mg/day of prednisone or the equivalent. They were randomly assigned (1:1) to 52 weeks of treatment with subcutaneous sarilumab 200 mg every 2 weeks plus the rapid 14-week glucocorticoid tapering regimen or were given placebo every 2 weeks plus a more traditional 52-week tapering of glucocorticoids.
 

COVID hampered recruitment

Recruitment was stopped early because of complications during the COVID-19 pandemic, so between October 2018 and July 2020, 118 of the intended 280 patients were recruited, and 117 were treated (sarilumab = 59, placebo = 58). Median age was 69 years in the treatment group and 70 among those taking placebo.

Of the 117 treated, only 78 patients (67%) completed treatment (sarilumab = 42, placebo = 36). The main reasons for stopping treatment were adverse events – including seven with sarilumab and four with placebo – and lack of efficacy (sarilumab = four, placebo = nine).

The primary outcome was the proportion of patients who reached sustained remission at 52 weeks, defined as disease remission by week 12 and no disease flare, normal C-reactive protein (CRP), and adherence to the glucocorticoid taper during weeks 12-52.

The researchers found that sustained remission was significantly higher in the sarilumab arm versus the control group (28.3% versus 10.3%; P = .0193).

IL-6 inhibitors lower CRP, but if you take CRP out of the definition, Dr. Spiera said, “we still saw this difference: 31.7% of patients treated with sarilumab and 13.8% treated with placebo and a longer taper achieved that endpoint.”
 

Forty-four percent lower risk of flare with sarilumab

Patients in the sarilumab group also had 44% lower risk of having a flare after achieving clinical remission versus the comparator group (16.7% versus 29.3%; hazard ratio, 0.56; 95% confidence interval, 0.35-0.90; P = .0153).

Patient-reported outcomes, which included physical and mental health scores and disability index results, favored sarilumab.

The incidence of treatment-emergent adverse events (TEAEs) was numerically higher in the sarilumab group, compared with the control group (94.9% versus 84.5%). TEAEs included neutropenia (15.3%) and arthralgia (15.3%) in the sarilumab group and insomnia (15.5%) in the comparator arm.

However, the frequency of serious AEs was higher in the control group, compared with the sarilumab arm (20.7% versus 13.6%). No deaths were reported, and, importantly in this age group treated with concurrent glucocorticoids and an IL-6 inhibitor, Dr. Spiera said, “there were no cases of diverticulitis requiring intervention.”

Dr. Spiera was asked about a seemingly low remission rate. He answered that the bar was very high for remission in this study.

Patients had to achieve remission by week 12 and with the rapid 14-week taper. “That means by week 12 the sarilumab arm patients were only on 2 mg of daily prednisone or its equivalent,” he said.

Patients had to maintain that for another 40 weeks, he noted, adding, “I think especially in the context of quality of life and function indices, these were important results.”

Sebastian E. Sattui, MD, director of the University of Pittsburgh Medical Center vasculitis clinic, told this news organization that prolonged use of glucocorticoids in patients with PMR remains an important concern and the need for other options is critical.

“Around 30% of patients with PMR remain on prednisone 5 years after diagnosis,” he said. “Low-dose glucocorticoids are still associated with significant morbidity. Until recently, there has been a paucity of high-quality data regarding the use of steroid-sparing agents in PMR. “

He noted that the SAPHYR trial data are promising “with sarilumab being successful in achieving remission while minimizing glucocorticoids in patients with relapsing PMR.” The clinically meaningful improvement in patient-reported outcomes was just as important, he added.

The main unanswered question is whether the disease-modifying ability of sarilumab will continue after it is stopped, Dr. Sattui said.

Dr. Spiera is a consultant for Sanofi, which funded the trial. He also disclosed financial relationships with GlaxoSmithKline, Boehringer Ingelheim, Corbus, InflaRx, AbbVie/Abbott, Novartis, Chemocentryx, Roche, and Vera. Dr. Sattui has received research support from AstraZeneca and has done unpaid consulting work for Sanofi.

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

PHILADELPHIA – Treatment with the interleukin-6 receptor antagonist sarilumab (Kevzara), along with a 14-week taper of glucocorticoids, proved to have significant efficacy in patients with relapsing polymyalgia rheumatica (PMR) who were resistant to glucocorticoids in a phase 3 trial.

No new safety concerns were found with sarilumab in the multicenter, randomized, double-blind, placebo-controlled SAPHYR trial. Sarilumab is approved in the United States for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.

The results, presented at the annual meeting of the American College of Rheumatology by Robert Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery in New York, included clinically meaningful improvement in quality-of-life scores.

The disease, which primarily affects people over age 65, can cause widespread aching and stiffness. It’s one of the most common inflammatory diseases among older adults.

PMR is relatively easy to treat with glucocorticoids, but relapses are common, which means long courses of glucocorticoid therapy and the side effects that come with them.
 

Need for a steroid-sparing therapy

“We recognize that a steroid-sparing drug in polymyalgia rheumatica seems to be an unmet need,” Dr. Spiera said at the meeting.

The trial, sponsored by Sanofi, included active, refractory PMR patients who flared within 3 months of study entry while on at least 7.5 mg/day of prednisone or the equivalent. They were randomly assigned (1:1) to 52 weeks of treatment with subcutaneous sarilumab 200 mg every 2 weeks plus the rapid 14-week glucocorticoid tapering regimen or were given placebo every 2 weeks plus a more traditional 52-week tapering of glucocorticoids.
 

COVID hampered recruitment

Recruitment was stopped early because of complications during the COVID-19 pandemic, so between October 2018 and July 2020, 118 of the intended 280 patients were recruited, and 117 were treated (sarilumab = 59, placebo = 58). Median age was 69 years in the treatment group and 70 among those taking placebo.

Of the 117 treated, only 78 patients (67%) completed treatment (sarilumab = 42, placebo = 36). The main reasons for stopping treatment were adverse events – including seven with sarilumab and four with placebo – and lack of efficacy (sarilumab = four, placebo = nine).

The primary outcome was the proportion of patients who reached sustained remission at 52 weeks, defined as disease remission by week 12 and no disease flare, normal C-reactive protein (CRP), and adherence to the glucocorticoid taper during weeks 12-52.

The researchers found that sustained remission was significantly higher in the sarilumab arm versus the control group (28.3% versus 10.3%; P = .0193).

IL-6 inhibitors lower CRP, but if you take CRP out of the definition, Dr. Spiera said, “we still saw this difference: 31.7% of patients treated with sarilumab and 13.8% treated with placebo and a longer taper achieved that endpoint.”
 

Forty-four percent lower risk of flare with sarilumab

Patients in the sarilumab group also had 44% lower risk of having a flare after achieving clinical remission versus the comparator group (16.7% versus 29.3%; hazard ratio, 0.56; 95% confidence interval, 0.35-0.90; P = .0153).

Patient-reported outcomes, which included physical and mental health scores and disability index results, favored sarilumab.

The incidence of treatment-emergent adverse events (TEAEs) was numerically higher in the sarilumab group, compared with the control group (94.9% versus 84.5%). TEAEs included neutropenia (15.3%) and arthralgia (15.3%) in the sarilumab group and insomnia (15.5%) in the comparator arm.

However, the frequency of serious AEs was higher in the control group, compared with the sarilumab arm (20.7% versus 13.6%). No deaths were reported, and, importantly in this age group treated with concurrent glucocorticoids and an IL-6 inhibitor, Dr. Spiera said, “there were no cases of diverticulitis requiring intervention.”

Dr. Spiera was asked about a seemingly low remission rate. He answered that the bar was very high for remission in this study.

Patients had to achieve remission by week 12 and with the rapid 14-week taper. “That means by week 12 the sarilumab arm patients were only on 2 mg of daily prednisone or its equivalent,” he said.

Patients had to maintain that for another 40 weeks, he noted, adding, “I think especially in the context of quality of life and function indices, these were important results.”

Sebastian E. Sattui, MD, director of the University of Pittsburgh Medical Center vasculitis clinic, told this news organization that prolonged use of glucocorticoids in patients with PMR remains an important concern and the need for other options is critical.

“Around 30% of patients with PMR remain on prednisone 5 years after diagnosis,” he said. “Low-dose glucocorticoids are still associated with significant morbidity. Until recently, there has been a paucity of high-quality data regarding the use of steroid-sparing agents in PMR. “

He noted that the SAPHYR trial data are promising “with sarilumab being successful in achieving remission while minimizing glucocorticoids in patients with relapsing PMR.” The clinically meaningful improvement in patient-reported outcomes was just as important, he added.

The main unanswered question is whether the disease-modifying ability of sarilumab will continue after it is stopped, Dr. Sattui said.

Dr. Spiera is a consultant for Sanofi, which funded the trial. He also disclosed financial relationships with GlaxoSmithKline, Boehringer Ingelheim, Corbus, InflaRx, AbbVie/Abbott, Novartis, Chemocentryx, Roche, and Vera. Dr. Sattui has received research support from AstraZeneca and has done unpaid consulting work for Sanofi.

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

PHILADELPHIA – Treatment with the interleukin-6 receptor antagonist sarilumab (Kevzara), along with a 14-week taper of glucocorticoids, proved to have significant efficacy in patients with relapsing polymyalgia rheumatica (PMR) who were resistant to glucocorticoids in a phase 3 trial.

No new safety concerns were found with sarilumab in the multicenter, randomized, double-blind, placebo-controlled SAPHYR trial. Sarilumab is approved in the United States for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.

The results, presented at the annual meeting of the American College of Rheumatology by Robert Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery in New York, included clinically meaningful improvement in quality-of-life scores.

The disease, which primarily affects people over age 65, can cause widespread aching and stiffness. It’s one of the most common inflammatory diseases among older adults.

PMR is relatively easy to treat with glucocorticoids, but relapses are common, which means long courses of glucocorticoid therapy and the side effects that come with them.
 

Need for a steroid-sparing therapy

“We recognize that a steroid-sparing drug in polymyalgia rheumatica seems to be an unmet need,” Dr. Spiera said at the meeting.

The trial, sponsored by Sanofi, included active, refractory PMR patients who flared within 3 months of study entry while on at least 7.5 mg/day of prednisone or the equivalent. They were randomly assigned (1:1) to 52 weeks of treatment with subcutaneous sarilumab 200 mg every 2 weeks plus the rapid 14-week glucocorticoid tapering regimen or were given placebo every 2 weeks plus a more traditional 52-week tapering of glucocorticoids.
 

COVID hampered recruitment

Recruitment was stopped early because of complications during the COVID-19 pandemic, so between October 2018 and July 2020, 118 of the intended 280 patients were recruited, and 117 were treated (sarilumab = 59, placebo = 58). Median age was 69 years in the treatment group and 70 among those taking placebo.

Of the 117 treated, only 78 patients (67%) completed treatment (sarilumab = 42, placebo = 36). The main reasons for stopping treatment were adverse events – including seven with sarilumab and four with placebo – and lack of efficacy (sarilumab = four, placebo = nine).

The primary outcome was the proportion of patients who reached sustained remission at 52 weeks, defined as disease remission by week 12 and no disease flare, normal C-reactive protein (CRP), and adherence to the glucocorticoid taper during weeks 12-52.

The researchers found that sustained remission was significantly higher in the sarilumab arm versus the control group (28.3% versus 10.3%; P = .0193).

IL-6 inhibitors lower CRP, but if you take CRP out of the definition, Dr. Spiera said, “we still saw this difference: 31.7% of patients treated with sarilumab and 13.8% treated with placebo and a longer taper achieved that endpoint.”
 

Forty-four percent lower risk of flare with sarilumab

Patients in the sarilumab group also had 44% lower risk of having a flare after achieving clinical remission versus the comparator group (16.7% versus 29.3%; hazard ratio, 0.56; 95% confidence interval, 0.35-0.90; P = .0153).

Patient-reported outcomes, which included physical and mental health scores and disability index results, favored sarilumab.

The incidence of treatment-emergent adverse events (TEAEs) was numerically higher in the sarilumab group, compared with the control group (94.9% versus 84.5%). TEAEs included neutropenia (15.3%) and arthralgia (15.3%) in the sarilumab group and insomnia (15.5%) in the comparator arm.

However, the frequency of serious AEs was higher in the control group, compared with the sarilumab arm (20.7% versus 13.6%). No deaths were reported, and, importantly in this age group treated with concurrent glucocorticoids and an IL-6 inhibitor, Dr. Spiera said, “there were no cases of diverticulitis requiring intervention.”

Dr. Spiera was asked about a seemingly low remission rate. He answered that the bar was very high for remission in this study.

Patients had to achieve remission by week 12 and with the rapid 14-week taper. “That means by week 12 the sarilumab arm patients were only on 2 mg of daily prednisone or its equivalent,” he said.

Patients had to maintain that for another 40 weeks, he noted, adding, “I think especially in the context of quality of life and function indices, these were important results.”

Sebastian E. Sattui, MD, director of the University of Pittsburgh Medical Center vasculitis clinic, told this news organization that prolonged use of glucocorticoids in patients with PMR remains an important concern and the need for other options is critical.

“Around 30% of patients with PMR remain on prednisone 5 years after diagnosis,” he said. “Low-dose glucocorticoids are still associated with significant morbidity. Until recently, there has been a paucity of high-quality data regarding the use of steroid-sparing agents in PMR. “

He noted that the SAPHYR trial data are promising “with sarilumab being successful in achieving remission while minimizing glucocorticoids in patients with relapsing PMR.” The clinically meaningful improvement in patient-reported outcomes was just as important, he added.

The main unanswered question is whether the disease-modifying ability of sarilumab will continue after it is stopped, Dr. Sattui said.

Dr. Spiera is a consultant for Sanofi, which funded the trial. He also disclosed financial relationships with GlaxoSmithKline, Boehringer Ingelheim, Corbus, InflaRx, AbbVie/Abbott, Novartis, Chemocentryx, Roche, and Vera. Dr. Sattui has received research support from AstraZeneca and has done unpaid consulting work for Sanofi.

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

In September, the World Professional Association for Transgender Health released its much-anticipated standards of care (SOC8). While this update has unfortunately received intense scrutiny for its guidance about gender-diverse adolescents and youth, the SOC8 is their most evidence-based version to date. Recommendations were developed based on data from independent systematic literature reviews, background reviews, and expert opinions.¹ These guidelines also recognize knowledge deficits and are intended to be flexible to meet the individual needs of transgender patients. While the scope of this column will not delve into all 258 pages of these new standards, it will highlight pertinent information on hormonal management.

Ever since the original publication of the standards of care in 1979, gender-affirming hormone therapy (GAHT) has been considered medically necessary. The approach to GAHT depends on the patient’s goals and the age at which the patient is seeking to medically transition. Given the complexity of GAHT for transgender youth and adolescents, this article will focus primarily on adult patients.

There are a few pertinent differences in the management and monitoring of GAHT in adults. For patients assigned female at birth, testosterone is the primary modality by which patients can achieve masculinizing features. GAHT for patients assigned male at birth often consists of estrogen and an androgen-lowering medication. Like its predecessor, SOC8 recommends against prescribing ethinyl estradiol because of its marked association with thromboembolic events.

While the formulations of estrogen (oral, injectable, and patches) and hormone blockers (finasteride, spironolactone, gonadotropin-releasing hormone agonists, and bicalutamide) are discussed in prior standards of care, SOC8 further delineates their utilization. It suggests that transdermal estrogen should be considered in transgender women over the age of 45 who are at high risk for developing a venous thromboembolism or have a previous history of thromboembolism. Furthermore, SOC8 establishes spironolactone as the mainstay for androgen blockage and discourages routine usage of bicalutamide and finasteride because of a lack of safety data and questionable efficacy.¹ Even though some patients anecdotally report increased breast growth with progesterone supplementation, there is insufficient evidence to regularly prescribe progesterone for breast development.¹

Both WPATH and the Endocrine Society recommend checking serum levels of sex hormones every 3 months during the first year until stable levels are achieved, then once or twice a year thereafter.¹ Hormone levels should be maintained at physiologic concentrations of the targeted gender. Some patients on feminizing GAHT often request evaluation of estrone/estradiol ratios as there was an assumption that higher ratios were associated with antagonistic effects on breast development. However, recent published evidence refutes this claim and estrone/estradiol ratios need not be measured.¹

In addition to monitoring sex hormone levels, providers should check the metabolic effects that can be associated with GAHT. Both testosterone and estrogen can influence lipid panels: Testosterone can increase the red blood cell count, and spironolactone may cause hyperkalemia. While the SOC7 previously encouraged assessment of these laboratory values every 3 months, the new guidelines are more flexible in the frequency of testing of asymptomatic individuals as there is no strong evidence from published studies that supports these 3-month intervals.¹

Providers are responsible for informing patients about the possible effects of GAHT on fertility. Estrogen often will cause a reduction in spermatogenesis, which may be irreversible. Patients who plan on taking estrogen should be counseled regarding sperm cryopreservation prior to starting GAHT. Even though testosterone inhibits ovulation and induces menstrual suppression, patients often regain their fertility after cessation of testosterone therapy. However, given the significant knowledge deficit about long-term fertility in transmasculine patients, providers should still offer oocyte or embryo cryopreservation.

Health care providers should collaborate with surgeons regarding preoperative and postoperative GAHT. To mitigate the risk of thromboembolism, many surgeons would stop hormones 1-4 weeks before and after gender-affirming surgery. Recent evidence does not support this practice, as studies indicate no increased risk for venous thromboembolism in individuals on GAHT undergoing surgery. These studies are consistent with other well-established guidelines on preoperative management of cisgender women taking estrogen or progestins. As exogenous sex steroids are necessary for bone health in patients who undergo gonadectomy, surgeons and other health care providers should educate patients on the importance of continuing GAHT.

There are many procedures available for gender-affirming surgery. Many of these surgeries involve three regions: the face, chest/breast, and/or genitalia (both internal and external). Prior to making a surgical referral, providers should be familiar with the surgeon’s scope of practice, performance measures, and surgical outcomes.¹ For the first time, the SOC8 also addresses the surgical training of the providers who offer these procedures. While gender-affirming surgery can be performed by a variety of different specialists, training and documented supervision (often by an existing expert in gender-affirming surgery) is essential. Maintaining an active practice in these procedures, tracking surgical outcomes, and continuing education within the field of gender-affirming surgery are additional requirements for surgeons performing these complex operations.¹

As their name implies, the SOC8 attempts to create a standardized guide to assist practitioners caring for gender-diverse patients. It’s important for providers to be familiar with updates while also recognizing the evolving nature of this rapidly growing field.

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

Reference

1. World Professional Association for Transgender Health. Standards of care for the health of transgender and gender diverse people, Version 8. Int J Transgend Health. 2022 Sep 15. doi: 10.1080/26895269.2022.2100644.

In September, the World Professional Association for Transgender Health released its much-anticipated standards of care (SOC8). While this update has unfortunately received intense scrutiny for its guidance about gender-diverse adolescents and youth, the SOC8 is their most evidence-based version to date. Recommendations were developed based on data from independent systematic literature reviews, background reviews, and expert opinions.¹ These guidelines also recognize knowledge deficits and are intended to be flexible to meet the individual needs of transgender patients. While the scope of this column will not delve into all 258 pages of these new standards, it will highlight pertinent information on hormonal management.

Ever since the original publication of the standards of care in 1979, gender-affirming hormone therapy (GAHT) has been considered medically necessary. The approach to GAHT depends on the patient’s goals and the age at which the patient is seeking to medically transition. Given the complexity of GAHT for transgender youth and adolescents, this article will focus primarily on adult patients.

There are a few pertinent differences in the management and monitoring of GAHT in adults. For patients assigned female at birth, testosterone is the primary modality by which patients can achieve masculinizing features. GAHT for patients assigned male at birth often consists of estrogen and an androgen-lowering medication. Like its predecessor, SOC8 recommends against prescribing ethinyl estradiol because of its marked association with thromboembolic events.

While the formulations of estrogen (oral, injectable, and patches) and hormone blockers (finasteride, spironolactone, gonadotropin-releasing hormone agonists, and bicalutamide) are discussed in prior standards of care, SOC8 further delineates their utilization. It suggests that transdermal estrogen should be considered in transgender women over the age of 45 who are at high risk for developing a venous thromboembolism or have a previous history of thromboembolism. Furthermore, SOC8 establishes spironolactone as the mainstay for androgen blockage and discourages routine usage of bicalutamide and finasteride because of a lack of safety data and questionable efficacy.¹ Even though some patients anecdotally report increased breast growth with progesterone supplementation, there is insufficient evidence to regularly prescribe progesterone for breast development.¹

Both WPATH and the Endocrine Society recommend checking serum levels of sex hormones every 3 months during the first year until stable levels are achieved, then once or twice a year thereafter.¹ Hormone levels should be maintained at physiologic concentrations of the targeted gender. Some patients on feminizing GAHT often request evaluation of estrone/estradiol ratios as there was an assumption that higher ratios were associated with antagonistic effects on breast development. However, recent published evidence refutes this claim and estrone/estradiol ratios need not be measured.¹

In addition to monitoring sex hormone levels, providers should check the metabolic effects that can be associated with GAHT. Both testosterone and estrogen can influence lipid panels: Testosterone can increase the red blood cell count, and spironolactone may cause hyperkalemia. While the SOC7 previously encouraged assessment of these laboratory values every 3 months, the new guidelines are more flexible in the frequency of testing of asymptomatic individuals as there is no strong evidence from published studies that supports these 3-month intervals.¹

Providers are responsible for informing patients about the possible effects of GAHT on fertility. Estrogen often will cause a reduction in spermatogenesis, which may be irreversible. Patients who plan on taking estrogen should be counseled regarding sperm cryopreservation prior to starting GAHT. Even though testosterone inhibits ovulation and induces menstrual suppression, patients often regain their fertility after cessation of testosterone therapy. However, given the significant knowledge deficit about long-term fertility in transmasculine patients, providers should still offer oocyte or embryo cryopreservation.

Health care providers should collaborate with surgeons regarding preoperative and postoperative GAHT. To mitigate the risk of thromboembolism, many surgeons would stop hormones 1-4 weeks before and after gender-affirming surgery. Recent evidence does not support this practice, as studies indicate no increased risk for venous thromboembolism in individuals on GAHT undergoing surgery. These studies are consistent with other well-established guidelines on preoperative management of cisgender women taking estrogen or progestins. As exogenous sex steroids are necessary for bone health in patients who undergo gonadectomy, surgeons and other health care providers should educate patients on the importance of continuing GAHT.

There are many procedures available for gender-affirming surgery. Many of these surgeries involve three regions: the face, chest/breast, and/or genitalia (both internal and external). Prior to making a surgical referral, providers should be familiar with the surgeon’s scope of practice, performance measures, and surgical outcomes.¹ For the first time, the SOC8 also addresses the surgical training of the providers who offer these procedures. While gender-affirming surgery can be performed by a variety of different specialists, training and documented supervision (often by an existing expert in gender-affirming surgery) is essential. Maintaining an active practice in these procedures, tracking surgical outcomes, and continuing education within the field of gender-affirming surgery are additional requirements for surgeons performing these complex operations.¹

As their name implies, the SOC8 attempts to create a standardized guide to assist practitioners caring for gender-diverse patients. It’s important for providers to be familiar with updates while also recognizing the evolving nature of this rapidly growing field.

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

Reference

1. World Professional Association for Transgender Health. Standards of care for the health of transgender and gender diverse people, Version 8. Int J Transgend Health. 2022 Sep 15. doi: 10.1080/26895269.2022.2100644.

In September, the World Professional Association for Transgender Health released its much-anticipated standards of care (SOC8). While this update has unfortunately received intense scrutiny for its guidance about gender-diverse adolescents and youth, the SOC8 is their most evidence-based version to date. Recommendations were developed based on data from independent systematic literature reviews, background reviews, and expert opinions.¹ These guidelines also recognize knowledge deficits and are intended to be flexible to meet the individual needs of transgender patients. While the scope of this column will not delve into all 258 pages of these new standards, it will highlight pertinent information on hormonal management.

Ever since the original publication of the standards of care in 1979, gender-affirming hormone therapy (GAHT) has been considered medically necessary. The approach to GAHT depends on the patient’s goals and the age at which the patient is seeking to medically transition. Given the complexity of GAHT for transgender youth and adolescents, this article will focus primarily on adult patients.

There are a few pertinent differences in the management and monitoring of GAHT in adults. For patients assigned female at birth, testosterone is the primary modality by which patients can achieve masculinizing features. GAHT for patients assigned male at birth often consists of estrogen and an androgen-lowering medication. Like its predecessor, SOC8 recommends against prescribing ethinyl estradiol because of its marked association with thromboembolic events.

While the formulations of estrogen (oral, injectable, and patches) and hormone blockers (finasteride, spironolactone, gonadotropin-releasing hormone agonists, and bicalutamide) are discussed in prior standards of care, SOC8 further delineates their utilization. It suggests that transdermal estrogen should be considered in transgender women over the age of 45 who are at high risk for developing a venous thromboembolism or have a previous history of thromboembolism. Furthermore, SOC8 establishes spironolactone as the mainstay for androgen blockage and discourages routine usage of bicalutamide and finasteride because of a lack of safety data and questionable efficacy.¹ Even though some patients anecdotally report increased breast growth with progesterone supplementation, there is insufficient evidence to regularly prescribe progesterone for breast development.¹

Both WPATH and the Endocrine Society recommend checking serum levels of sex hormones every 3 months during the first year until stable levels are achieved, then once or twice a year thereafter.¹ Hormone levels should be maintained at physiologic concentrations of the targeted gender. Some patients on feminizing GAHT often request evaluation of estrone/estradiol ratios as there was an assumption that higher ratios were associated with antagonistic effects on breast development. However, recent published evidence refutes this claim and estrone/estradiol ratios need not be measured.¹

In addition to monitoring sex hormone levels, providers should check the metabolic effects that can be associated with GAHT. Both testosterone and estrogen can influence lipid panels: Testosterone can increase the red blood cell count, and spironolactone may cause hyperkalemia. While the SOC7 previously encouraged assessment of these laboratory values every 3 months, the new guidelines are more flexible in the frequency of testing of asymptomatic individuals as there is no strong evidence from published studies that supports these 3-month intervals.¹

Providers are responsible for informing patients about the possible effects of GAHT on fertility. Estrogen often will cause a reduction in spermatogenesis, which may be irreversible. Patients who plan on taking estrogen should be counseled regarding sperm cryopreservation prior to starting GAHT. Even though testosterone inhibits ovulation and induces menstrual suppression, patients often regain their fertility after cessation of testosterone therapy. However, given the significant knowledge deficit about long-term fertility in transmasculine patients, providers should still offer oocyte or embryo cryopreservation.

Health care providers should collaborate with surgeons regarding preoperative and postoperative GAHT. To mitigate the risk of thromboembolism, many surgeons would stop hormones 1-4 weeks before and after gender-affirming surgery. Recent evidence does not support this practice, as studies indicate no increased risk for venous thromboembolism in individuals on GAHT undergoing surgery. These studies are consistent with other well-established guidelines on preoperative management of cisgender women taking estrogen or progestins. As exogenous sex steroids are necessary for bone health in patients who undergo gonadectomy, surgeons and other health care providers should educate patients on the importance of continuing GAHT.

There are many procedures available for gender-affirming surgery. Many of these surgeries involve three regions: the face, chest/breast, and/or genitalia (both internal and external). Prior to making a surgical referral, providers should be familiar with the surgeon’s scope of practice, performance measures, and surgical outcomes.¹ For the first time, the SOC8 also addresses the surgical training of the providers who offer these procedures. While gender-affirming surgery can be performed by a variety of different specialists, training and documented supervision (often by an existing expert in gender-affirming surgery) is essential. Maintaining an active practice in these procedures, tracking surgical outcomes, and continuing education within the field of gender-affirming surgery are additional requirements for surgeons performing these complex operations.¹

As their name implies, the SOC8 attempts to create a standardized guide to assist practitioners caring for gender-diverse patients. It’s important for providers to be familiar with updates while also recognizing the evolving nature of this rapidly growing field.

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

Reference

1. World Professional Association for Transgender Health. Standards of care for the health of transgender and gender diverse people, Version 8. Int J Transgend Health. 2022 Sep 15. doi: 10.1080/26895269.2022.2100644.

To the Editor:

An 82-year-old man presented to our dermatology clinic for a total-body skin examination due to a recently diagnosed primary melanoma of the left middle ear. He reported pain of the left ear and water behind the left eardrum of 1 year’s duration. An otorhinolaryngologist performed surgery due to the severe mastoiditis. A biopsy of the contents of the left middle ear revealed malignant melanoma. Positron emission tomography–computed tomography revealed the mass was mainly located in the anterior aspect of the left middle ear with suspicion of tumor extension into the bony portion of the eustachian tube. No other disease was present. Prior to presentation to dermatology, gross excision of the left middle ear with removal of additional melanoma was confirmed by biopsy, and further analysis revealed v-Raf murine sarcoma viral oncogene (BRAF) was not detected while cellular proto-oncogene receptor kinase (KIT) mutation was detected on exon 13p (K642E).

The patient had no family history of melanoma. He never smoked and did not have contact with hazardous material. Initial examination at our clinic revealed no other suspicious pigmented lesions. After additional negative workup by the oncologist, the patient was presented to the tumor board, and postoperative radiotherapy was recommended to improve local control. Eight months after the patient’s initial diagnosis of the primary middle ear melanoma, a computed tomography–guided right lung biopsy showed metastatic melanoma. After various treatment modalities were discussed with the patient and his family, he was started on pembrolizumab. After 6 months on pembrolizumab, the patient developed autoimmune pneumonitis and pembrolizumab was discontinued. The patient elected to discontinue treatment and died 6 months later.

Malignant melanoma with primary involvement of the middle ear and mastoid mucosa rarely has been reported.^1-3 Primary malignant melanoma of the middle ear mucosa is difficult to diagnose clinically. Difficulty and delay in diagnosis occur because of the location and frequent lack of pathognomonic symptoms of the disease.² A comprehensive literature review by Maxwell et al³ in 2018 of the 10 reported primary middle ear mucosal melanomas found that patients most commonly presented with otorrhea, aural fullness, and hearing loss. Less common symptoms included otalgia, tinnitus, and facial weakness. Clinical examination revealed patients presented with serous otitis and/or a visible mass within the middle ear or external auditory canal. These melanomas demonstrated particularly poor outcomes, with 70% mortality, 20% local recurrence, and 50% distant metastasis. Distant metastases that occurred with primary middle ear mucosal melanoma include lung, liver, intraparotid, abdomen, and cutaneous metastasis.³

The specific pathophysiologic factors underlying the development of primary malignant melanoma of the middle ear mucosa are not known.² The middle ear and its components develop from the first and second pharyngeal arches.⁴ Melanocyte precursors from the neural crest migrate during the seventh or eighth week of embryogenesis. These precursors migrate to the epidermis, various mucosal epithelial, hair follicles, dermis, retina, uveal tract, leptomeninges, inner ear, and other tissues.⁵ The ossicles of the middle ear develop from the neural crest⁶ and remain in the mesenchyme until the eighth month, when the surrounding tissue dissolves.⁴ Cutaneous melanomas arise from the malignant transformation of melanocytes in the skin of neural crest lineage. Noncutaneous melanomas are hypothesized to arise from melanoblasts migrating to noncutaneous organs after neural crest cells undergo an epithelial-mesenchymal translation.⁷

Melanoma 5-year survival rates vary based on the melanoma disease stage: 98% for stage 1, 90% for stage 2, 70% for stage 3, and 10% for stage 4. Although early-stage disease mainly is treated with surgery, advanced and unresectable disease is managed with different therapeutic options, including BRAF inhibitors such as vemurafenib, dabrafenib mesylate, and encorafenib; immune checkpoint inhibitors such as ipilimumab, nivolumab, and pembrolizumab; and oncolytic virus such as talimogene laherparepvec.^8,9

Ninety percent of melanomas are of cutaneous origin. Extracutaneous melanomas may be derived from the uvea, leptomeninges, mucous membranes, and gastrointestinal tract.¹⁰ Mucosal melanomas are rare and represent only approximately 1% of all melanomas.¹¹ In order of frequency, primary mucosal melanomas include the head and neck, anorectal region, vulvovaginal region, and urinary tract. UV radiation exposure is an important risk factor for cutaneous melanoma but has not been associated with the development of mucosal melanoma.⁷ In 2019, Altieri et al¹¹ analyzed 1824 cases of mucosal melanoma and found that anatomic site influences survival because mucosal melanomas in the most occult anatomic sites—spinal/central nervous system, lung and pleura, liver, and pancreas—have the worst prognosis, likely because they have already metastasized by the time they are diagnosed. Due to their occult anatomic location and lack of early presenting signs and symptoms, mucosal melanomas are difficult to diagnose at an early stage, resulting in a poorer prognosis compared with cutaneous melanomas. The most important prognostic indicator for cutaneous melanomas of tumor thickness (ie, Breslow depth) provides less prognostic value for patients with mucosal melanoma. Limitations also include the lack of a standardized staging system for mucosal melanoma, but Altieri et al¹¹ found that poorer survival in patients with mucosal melanoma was observed in relation to stage based on the clinical and pathologic tumor-node-metastasis staging system of the Surveillance, Epidemiology, and End Results program. An aggregate 5-year survival estimate of patients diagnosed with mucosal melanoma is 28%, underscoring that mucosal melanoma is an aggressive melanoma that carries a poor prognosis and warrants a more aggressive treatment approach at the time of diagnosis.¹¹

Common treatment of primary middle ear mucosal melanoma involves a multimodality therapy including surgical oncological resection for most patients. Currently, radiation is in use for adjuvant treatment and definitive therapy in unresectable tumors or patients who are poor surgical candidates. Malignant melanoma traditionally was considered radioresistant, yet considerable variability in responsiveness has been observed both within and between tumors. Although there are no defined indications for adjuvant therapy, it is often administered in advanced or recurrent cases and those with positive or close margins. Chemotherapy generally is reserved for patients with systemic disease. The chemotherapeutic agents that have been used in the treatment of patients with melanoma of the middle ear include the alkylating agents dacarbazine, cisplatin, nimustine, paclitaxel, and temozolomide. Also, chemotherapeutic agents that have been reported in the treatment of melanoma of the middle ear include tamoxifen, the selective estrogen receptor inhibitor, and interferon. Most recently, programed cell death protein 1 inhibitors pembrolizumab and nivolumab have been used in the treatment of middle ear melanoma. Outcomes remain poor with a high rate of mortality. Novel immunotherapeutic agents combined with adjuvant radiotherapy have been proposed to improve disease control and survival rates.³

Data on systemic therapies for mucosal melanomas are limited due to the rarity of the disease. Even with the development of novel therapies, outcomes remain poor for mucosal melanomas, and additional treatment strategies are needed. Although proto-oncogene BRAF mutations occur in 50% to 70% of cutaneous melanomas, these mutations are rare in mucosal melanomas.³ In mucosal melanomas, activating mutations of the cell receptor KIT are identified more frequently.⁷ Alterations in proto-oncogene KIT have been found in acral, mucosal, and cutaneous melanoma. KIT mutations were found on exons 11 and 13.¹² Variability in the biology of KIT is suggested. Treatment of melanomas with the KIT mutations with tyrosine inhibitors imatinib and nilotinib have shown variable benefits.¹⁰ In a 2019 study of 44 patients with mucosal melanoma, Moya-Plana et al¹³ found that in cases of unresectable and/or metastatic disease, immunotherapy with pembrolizumab had a better benefit-risk ratio than immune treatment with ipilimumab, a cytotoxic T-cell lymphocyte-associated protein 4 inhibitor.

Primary malignant melanoma of the middle ear is unusual and difficult to diagnose clinically. These melanomas have a poor prognosis and can have distant metastasis including cutaneous metastasis. We present this case to emphasize the need to be aware that melanoma can arise in the middle ear.

To the Editor:

An 82-year-old man presented to our dermatology clinic for a total-body skin examination due to a recently diagnosed primary melanoma of the left middle ear. He reported pain of the left ear and water behind the left eardrum of 1 year’s duration. An otorhinolaryngologist performed surgery due to the severe mastoiditis. A biopsy of the contents of the left middle ear revealed malignant melanoma. Positron emission tomography–computed tomography revealed the mass was mainly located in the anterior aspect of the left middle ear with suspicion of tumor extension into the bony portion of the eustachian tube. No other disease was present. Prior to presentation to dermatology, gross excision of the left middle ear with removal of additional melanoma was confirmed by biopsy, and further analysis revealed v-Raf murine sarcoma viral oncogene (BRAF) was not detected while cellular proto-oncogene receptor kinase (KIT) mutation was detected on exon 13p (K642E).

The patient had no family history of melanoma. He never smoked and did not have contact with hazardous material. Initial examination at our clinic revealed no other suspicious pigmented lesions. After additional negative workup by the oncologist, the patient was presented to the tumor board, and postoperative radiotherapy was recommended to improve local control. Eight months after the patient’s initial diagnosis of the primary middle ear melanoma, a computed tomography–guided right lung biopsy showed metastatic melanoma. After various treatment modalities were discussed with the patient and his family, he was started on pembrolizumab. After 6 months on pembrolizumab, the patient developed autoimmune pneumonitis and pembrolizumab was discontinued. The patient elected to discontinue treatment and died 6 months later.

Malignant melanoma with primary involvement of the middle ear and mastoid mucosa rarely has been reported.^1-3 Primary malignant melanoma of the middle ear mucosa is difficult to diagnose clinically. Difficulty and delay in diagnosis occur because of the location and frequent lack of pathognomonic symptoms of the disease.² A comprehensive literature review by Maxwell et al³ in 2018 of the 10 reported primary middle ear mucosal melanomas found that patients most commonly presented with otorrhea, aural fullness, and hearing loss. Less common symptoms included otalgia, tinnitus, and facial weakness. Clinical examination revealed patients presented with serous otitis and/or a visible mass within the middle ear or external auditory canal. These melanomas demonstrated particularly poor outcomes, with 70% mortality, 20% local recurrence, and 50% distant metastasis. Distant metastases that occurred with primary middle ear mucosal melanoma include lung, liver, intraparotid, abdomen, and cutaneous metastasis.³

The specific pathophysiologic factors underlying the development of primary malignant melanoma of the middle ear mucosa are not known.² The middle ear and its components develop from the first and second pharyngeal arches.⁴ Melanocyte precursors from the neural crest migrate during the seventh or eighth week of embryogenesis. These precursors migrate to the epidermis, various mucosal epithelial, hair follicles, dermis, retina, uveal tract, leptomeninges, inner ear, and other tissues.⁵ The ossicles of the middle ear develop from the neural crest⁶ and remain in the mesenchyme until the eighth month, when the surrounding tissue dissolves.⁴ Cutaneous melanomas arise from the malignant transformation of melanocytes in the skin of neural crest lineage. Noncutaneous melanomas are hypothesized to arise from melanoblasts migrating to noncutaneous organs after neural crest cells undergo an epithelial-mesenchymal translation.⁷

Melanoma 5-year survival rates vary based on the melanoma disease stage: 98% for stage 1, 90% for stage 2, 70% for stage 3, and 10% for stage 4. Although early-stage disease mainly is treated with surgery, advanced and unresectable disease is managed with different therapeutic options, including BRAF inhibitors such as vemurafenib, dabrafenib mesylate, and encorafenib; immune checkpoint inhibitors such as ipilimumab, nivolumab, and pembrolizumab; and oncolytic virus such as talimogene laherparepvec.^8,9

Ninety percent of melanomas are of cutaneous origin. Extracutaneous melanomas may be derived from the uvea, leptomeninges, mucous membranes, and gastrointestinal tract.¹⁰ Mucosal melanomas are rare and represent only approximately 1% of all melanomas.¹¹ In order of frequency, primary mucosal melanomas include the head and neck, anorectal region, vulvovaginal region, and urinary tract. UV radiation exposure is an important risk factor for cutaneous melanoma but has not been associated with the development of mucosal melanoma.⁷ In 2019, Altieri et al¹¹ analyzed 1824 cases of mucosal melanoma and found that anatomic site influences survival because mucosal melanomas in the most occult anatomic sites—spinal/central nervous system, lung and pleura, liver, and pancreas—have the worst prognosis, likely because they have already metastasized by the time they are diagnosed. Due to their occult anatomic location and lack of early presenting signs and symptoms, mucosal melanomas are difficult to diagnose at an early stage, resulting in a poorer prognosis compared with cutaneous melanomas. The most important prognostic indicator for cutaneous melanomas of tumor thickness (ie, Breslow depth) provides less prognostic value for patients with mucosal melanoma. Limitations also include the lack of a standardized staging system for mucosal melanoma, but Altieri et al¹¹ found that poorer survival in patients with mucosal melanoma was observed in relation to stage based on the clinical and pathologic tumor-node-metastasis staging system of the Surveillance, Epidemiology, and End Results program. An aggregate 5-year survival estimate of patients diagnosed with mucosal melanoma is 28%, underscoring that mucosal melanoma is an aggressive melanoma that carries a poor prognosis and warrants a more aggressive treatment approach at the time of diagnosis.¹¹

Common treatment of primary middle ear mucosal melanoma involves a multimodality therapy including surgical oncological resection for most patients. Currently, radiation is in use for adjuvant treatment and definitive therapy in unresectable tumors or patients who are poor surgical candidates. Malignant melanoma traditionally was considered radioresistant, yet considerable variability in responsiveness has been observed both within and between tumors. Although there are no defined indications for adjuvant therapy, it is often administered in advanced or recurrent cases and those with positive or close margins. Chemotherapy generally is reserved for patients with systemic disease. The chemotherapeutic agents that have been used in the treatment of patients with melanoma of the middle ear include the alkylating agents dacarbazine, cisplatin, nimustine, paclitaxel, and temozolomide. Also, chemotherapeutic agents that have been reported in the treatment of melanoma of the middle ear include tamoxifen, the selective estrogen receptor inhibitor, and interferon. Most recently, programed cell death protein 1 inhibitors pembrolizumab and nivolumab have been used in the treatment of middle ear melanoma. Outcomes remain poor with a high rate of mortality. Novel immunotherapeutic agents combined with adjuvant radiotherapy have been proposed to improve disease control and survival rates.³

Data on systemic therapies for mucosal melanomas are limited due to the rarity of the disease. Even with the development of novel therapies, outcomes remain poor for mucosal melanomas, and additional treatment strategies are needed. Although proto-oncogene BRAF mutations occur in 50% to 70% of cutaneous melanomas, these mutations are rare in mucosal melanomas.³ In mucosal melanomas, activating mutations of the cell receptor KIT are identified more frequently.⁷ Alterations in proto-oncogene KIT have been found in acral, mucosal, and cutaneous melanoma. KIT mutations were found on exons 11 and 13.¹² Variability in the biology of KIT is suggested. Treatment of melanomas with the KIT mutations with tyrosine inhibitors imatinib and nilotinib have shown variable benefits.¹⁰ In a 2019 study of 44 patients with mucosal melanoma, Moya-Plana et al¹³ found that in cases of unresectable and/or metastatic disease, immunotherapy with pembrolizumab had a better benefit-risk ratio than immune treatment with ipilimumab, a cytotoxic T-cell lymphocyte-associated protein 4 inhibitor.

Primary malignant melanoma of the middle ear is unusual and difficult to diagnose clinically. These melanomas have a poor prognosis and can have distant metastasis including cutaneous metastasis. We present this case to emphasize the need to be aware that melanoma can arise in the middle ear.

To the Editor:

An 82-year-old man presented to our dermatology clinic for a total-body skin examination due to a recently diagnosed primary melanoma of the left middle ear. He reported pain of the left ear and water behind the left eardrum of 1 year’s duration. An otorhinolaryngologist performed surgery due to the severe mastoiditis. A biopsy of the contents of the left middle ear revealed malignant melanoma. Positron emission tomography–computed tomography revealed the mass was mainly located in the anterior aspect of the left middle ear with suspicion of tumor extension into the bony portion of the eustachian tube. No other disease was present. Prior to presentation to dermatology, gross excision of the left middle ear with removal of additional melanoma was confirmed by biopsy, and further analysis revealed v-Raf murine sarcoma viral oncogene (BRAF) was not detected while cellular proto-oncogene receptor kinase (KIT) mutation was detected on exon 13p (K642E).

The patient had no family history of melanoma. He never smoked and did not have contact with hazardous material. Initial examination at our clinic revealed no other suspicious pigmented lesions. After additional negative workup by the oncologist, the patient was presented to the tumor board, and postoperative radiotherapy was recommended to improve local control. Eight months after the patient’s initial diagnosis of the primary middle ear melanoma, a computed tomography–guided right lung biopsy showed metastatic melanoma. After various treatment modalities were discussed with the patient and his family, he was started on pembrolizumab. After 6 months on pembrolizumab, the patient developed autoimmune pneumonitis and pembrolizumab was discontinued. The patient elected to discontinue treatment and died 6 months later.

Malignant melanoma with primary involvement of the middle ear and mastoid mucosa rarely has been reported.^1-3 Primary malignant melanoma of the middle ear mucosa is difficult to diagnose clinically. Difficulty and delay in diagnosis occur because of the location and frequent lack of pathognomonic symptoms of the disease.² A comprehensive literature review by Maxwell et al³ in 2018 of the 10 reported primary middle ear mucosal melanomas found that patients most commonly presented with otorrhea, aural fullness, and hearing loss. Less common symptoms included otalgia, tinnitus, and facial weakness. Clinical examination revealed patients presented with serous otitis and/or a visible mass within the middle ear or external auditory canal. These melanomas demonstrated particularly poor outcomes, with 70% mortality, 20% local recurrence, and 50% distant metastasis. Distant metastases that occurred with primary middle ear mucosal melanoma include lung, liver, intraparotid, abdomen, and cutaneous metastasis.³

The specific pathophysiologic factors underlying the development of primary malignant melanoma of the middle ear mucosa are not known.² The middle ear and its components develop from the first and second pharyngeal arches.⁴ Melanocyte precursors from the neural crest migrate during the seventh or eighth week of embryogenesis. These precursors migrate to the epidermis, various mucosal epithelial, hair follicles, dermis, retina, uveal tract, leptomeninges, inner ear, and other tissues.⁵ The ossicles of the middle ear develop from the neural crest⁶ and remain in the mesenchyme until the eighth month, when the surrounding tissue dissolves.⁴ Cutaneous melanomas arise from the malignant transformation of melanocytes in the skin of neural crest lineage. Noncutaneous melanomas are hypothesized to arise from melanoblasts migrating to noncutaneous organs after neural crest cells undergo an epithelial-mesenchymal translation.⁷

Melanoma 5-year survival rates vary based on the melanoma disease stage: 98% for stage 1, 90% for stage 2, 70% for stage 3, and 10% for stage 4. Although early-stage disease mainly is treated with surgery, advanced and unresectable disease is managed with different therapeutic options, including BRAF inhibitors such as vemurafenib, dabrafenib mesylate, and encorafenib; immune checkpoint inhibitors such as ipilimumab, nivolumab, and pembrolizumab; and oncolytic virus such as talimogene laherparepvec.^8,9

Ninety percent of melanomas are of cutaneous origin. Extracutaneous melanomas may be derived from the uvea, leptomeninges, mucous membranes, and gastrointestinal tract.¹⁰ Mucosal melanomas are rare and represent only approximately 1% of all melanomas.¹¹ In order of frequency, primary mucosal melanomas include the head and neck, anorectal region, vulvovaginal region, and urinary tract. UV radiation exposure is an important risk factor for cutaneous melanoma but has not been associated with the development of mucosal melanoma.⁷ In 2019, Altieri et al¹¹ analyzed 1824 cases of mucosal melanoma and found that anatomic site influences survival because mucosal melanomas in the most occult anatomic sites—spinal/central nervous system, lung and pleura, liver, and pancreas—have the worst prognosis, likely because they have already metastasized by the time they are diagnosed. Due to their occult anatomic location and lack of early presenting signs and symptoms, mucosal melanomas are difficult to diagnose at an early stage, resulting in a poorer prognosis compared with cutaneous melanomas. The most important prognostic indicator for cutaneous melanomas of tumor thickness (ie, Breslow depth) provides less prognostic value for patients with mucosal melanoma. Limitations also include the lack of a standardized staging system for mucosal melanoma, but Altieri et al¹¹ found that poorer survival in patients with mucosal melanoma was observed in relation to stage based on the clinical and pathologic tumor-node-metastasis staging system of the Surveillance, Epidemiology, and End Results program. An aggregate 5-year survival estimate of patients diagnosed with mucosal melanoma is 28%, underscoring that mucosal melanoma is an aggressive melanoma that carries a poor prognosis and warrants a more aggressive treatment approach at the time of diagnosis.¹¹

Common treatment of primary middle ear mucosal melanoma involves a multimodality therapy including surgical oncological resection for most patients. Currently, radiation is in use for adjuvant treatment and definitive therapy in unresectable tumors or patients who are poor surgical candidates. Malignant melanoma traditionally was considered radioresistant, yet considerable variability in responsiveness has been observed both within and between tumors. Although there are no defined indications for adjuvant therapy, it is often administered in advanced or recurrent cases and those with positive or close margins. Chemotherapy generally is reserved for patients with systemic disease. The chemotherapeutic agents that have been used in the treatment of patients with melanoma of the middle ear include the alkylating agents dacarbazine, cisplatin, nimustine, paclitaxel, and temozolomide. Also, chemotherapeutic agents that have been reported in the treatment of melanoma of the middle ear include tamoxifen, the selective estrogen receptor inhibitor, and interferon. Most recently, programed cell death protein 1 inhibitors pembrolizumab and nivolumab have been used in the treatment of middle ear melanoma. Outcomes remain poor with a high rate of mortality. Novel immunotherapeutic agents combined with adjuvant radiotherapy have been proposed to improve disease control and survival rates.³

Data on systemic therapies for mucosal melanomas are limited due to the rarity of the disease. Even with the development of novel therapies, outcomes remain poor for mucosal melanomas, and additional treatment strategies are needed. Although proto-oncogene BRAF mutations occur in 50% to 70% of cutaneous melanomas, these mutations are rare in mucosal melanomas.³ In mucosal melanomas, activating mutations of the cell receptor KIT are identified more frequently.⁷ Alterations in proto-oncogene KIT have been found in acral, mucosal, and cutaneous melanoma. KIT mutations were found on exons 11 and 13.¹² Variability in the biology of KIT is suggested. Treatment of melanomas with the KIT mutations with tyrosine inhibitors imatinib and nilotinib have shown variable benefits.¹⁰ In a 2019 study of 44 patients with mucosal melanoma, Moya-Plana et al¹³ found that in cases of unresectable and/or metastatic disease, immunotherapy with pembrolizumab had a better benefit-risk ratio than immune treatment with ipilimumab, a cytotoxic T-cell lymphocyte-associated protein 4 inhibitor.

Primary malignant melanoma of the middle ear is unusual and difficult to diagnose clinically. These melanomas have a poor prognosis and can have distant metastasis including cutaneous metastasis. We present this case to emphasize the need to be aware that melanoma can arise in the middle ear.

To the Editor:

The posttraumatic pseudolipoma (PTL) is a painless localized mass comprised of unencapsulated adipose tissue that develops at the site of acute or prolonged blunt soft tissue trauma. It may be round or fusiform in shape and has areas of saponification leading to fat necrosis.¹ Posttraumatic pseudolipomas are 12 times more likely to occur in females, which may be attributed to sex-determined adipose tissue distribution or cosmetic concerns.² Most PTLs are found in areas of the body with high adiposity, including the hip, thigh, and gluteal regions.³ A patient history of a traumatic event resulting in a hematoma and a subsequent latent period of several months to years before the pseudolipoma formation occurs is common.^1,2,4-6

A 27-year-old woman presented to the family medicine clinic for examination of a deformity on the right buttock. She noticed a soft protruding mass months after landing on the buttocks and on top of a stick during routine physical training. Prior ultrasonography of the deformity proved unhelpful in determining the etiology. Physical examination revealed a protruding, 2-cm, flesh-colored mass on the right buttock intergluteal fold that was soft, compressible, and nontender (Figure 1). There was no capsule, nodule, loculation, or sinus tract. The patient underwent excisional resection with findings of benign-appearing unencapsulated adipose tissue (Figure 2). The wound was closed without difficulty. After several weeks, she had a well-healing scar without contour deficits of the buttocks. Two to 3 months after the initial repair, the patient presented to the family medicine clinic with recurrence of the fatty protrusion. She was referred for consultation and definitive management to a plastic surgeon but was lost to follow up.

In a systematic review of the literature to research pathogenesis theories, a PubMed search of articles indexed for MEDLINE using the terms trauma and pseudolipoma, lipoma, fat, or adipose yielded 45 citations, with only 10 publications addressing the pathology specific to pseudolipomas. Two leading theories of the pathogenesis of PTLs include the adipose herniation pathway and the inflammatory proliferation pathway.^4,5

Adipose tissue comprises fat lobules that are organized underneath the supportive elastic fascial layers. Injury from forces exceeding the fascial strength is the basis for the oldest pathogenesis theory. The adipose herniation theory suggests that fat lobules are displaced through the damaged septae, allowing for the development of an epidermal pseudolipoma at the site of blunt trauma.⁷ This theory has been supported by many case reports; however, more recent reports have identified a larger number of PTL cases that showed no identifiable disruptions in the fascia.^1,4,8

In 1997, the inflammatory proliferation theory began to gain attention. The theory describes how local tissue trauma leads to the release of inflammatory cytokines, which successively signals the development of preadipocytes or adipose tissue–derived stem cells (ASCs) into mature adipocytes.⁴ Most patients report a history of a hematoma in the area of pseudolipoma development, which strongly supports this newer theory. Studies exploring hematomas have found elevated levels of growth factors and inflammatory markers.^2,9 In particular, tumor necrosis factor α, peroxisome proliferator–activated receptor γ, vascular endothelial growth factor, and IL-6 and IL-8 may foster an environment in which adipogenic cells are both chemotaxed to the area of trauma and differentiated to white adipose tissue.^2,10

Despite addressing the role of the preadipocyte, the available research fails to address the general development of mesenchymal cells into the preadipocyte. White adipose tissue develops at sites of neovascularization and frequently has been observed spreading into the nearby tissue toward other blood vessels. Furthermore, these white adipose tissue expansions remain reliant on multiple growth factors and cell-signaling molecules.¹⁰ Numerous investigations into stem cell grafting have found that implantation of ASCs in vivo within animal models does not result in the proliferation and differentiation of ASCs unless specific conditions have been met such as prior tissue injury or immunodeficiency.^10-12 These investigations support and expand on the inflammatory proliferation pathway. Thus, most of the true PTLs in the available research appear as de novo tumors and are more congruent with the inflammatory proliferation model.^1,2,4-6,8

Typical treatment of a PTL is surgical excision or liposuction depending on the pathology and size of the pseudolipoma. Biopsy examination prior to liposuction is critical for evaluation of liposarcoma and may help identify damage to Scarpa fascia. Recurrence of a PTL is rare regardless of treatment method; however, in a study of 31 PTL cases, only 6 were pathologically identified as PTLs without fibrous material.¹

Our patient experienced a blunt trauma to the buttocks and subsequently developed a PTL that was surgically excised and recurred within 3 months. Research surrounding the pathogenesis of the PTL has evolved from the theory of physical herniation of adipose tissue to an inflammatory differentiation of preadipocytes, but there is still much to learn about how and why it occurs and the mesenchymal differentiation following tissue injury.

To the Editor:

The posttraumatic pseudolipoma (PTL) is a painless localized mass comprised of unencapsulated adipose tissue that develops at the site of acute or prolonged blunt soft tissue trauma. It may be round or fusiform in shape and has areas of saponification leading to fat necrosis.¹ Posttraumatic pseudolipomas are 12 times more likely to occur in females, which may be attributed to sex-determined adipose tissue distribution or cosmetic concerns.² Most PTLs are found in areas of the body with high adiposity, including the hip, thigh, and gluteal regions.³ A patient history of a traumatic event resulting in a hematoma and a subsequent latent period of several months to years before the pseudolipoma formation occurs is common.^1,2,4-6

A 27-year-old woman presented to the family medicine clinic for examination of a deformity on the right buttock. She noticed a soft protruding mass months after landing on the buttocks and on top of a stick during routine physical training. Prior ultrasonography of the deformity proved unhelpful in determining the etiology. Physical examination revealed a protruding, 2-cm, flesh-colored mass on the right buttock intergluteal fold that was soft, compressible, and nontender (Figure 1). There was no capsule, nodule, loculation, or sinus tract. The patient underwent excisional resection with findings of benign-appearing unencapsulated adipose tissue (Figure 2). The wound was closed without difficulty. After several weeks, she had a well-healing scar without contour deficits of the buttocks. Two to 3 months after the initial repair, the patient presented to the family medicine clinic with recurrence of the fatty protrusion. She was referred for consultation and definitive management to a plastic surgeon but was lost to follow up.

In a systematic review of the literature to research pathogenesis theories, a PubMed search of articles indexed for MEDLINE using the terms trauma and pseudolipoma, lipoma, fat, or adipose yielded 45 citations, with only 10 publications addressing the pathology specific to pseudolipomas. Two leading theories of the pathogenesis of PTLs include the adipose herniation pathway and the inflammatory proliferation pathway.^4,5

Adipose tissue comprises fat lobules that are organized underneath the supportive elastic fascial layers. Injury from forces exceeding the fascial strength is the basis for the oldest pathogenesis theory. The adipose herniation theory suggests that fat lobules are displaced through the damaged septae, allowing for the development of an epidermal pseudolipoma at the site of blunt trauma.⁷ This theory has been supported by many case reports; however, more recent reports have identified a larger number of PTL cases that showed no identifiable disruptions in the fascia.^1,4,8

In 1997, the inflammatory proliferation theory began to gain attention. The theory describes how local tissue trauma leads to the release of inflammatory cytokines, which successively signals the development of preadipocytes or adipose tissue–derived stem cells (ASCs) into mature adipocytes.⁴ Most patients report a history of a hematoma in the area of pseudolipoma development, which strongly supports this newer theory. Studies exploring hematomas have found elevated levels of growth factors and inflammatory markers.^2,9 In particular, tumor necrosis factor α, peroxisome proliferator–activated receptor γ, vascular endothelial growth factor, and IL-6 and IL-8 may foster an environment in which adipogenic cells are both chemotaxed to the area of trauma and differentiated to white adipose tissue.^2,10

Despite addressing the role of the preadipocyte, the available research fails to address the general development of mesenchymal cells into the preadipocyte. White adipose tissue develops at sites of neovascularization and frequently has been observed spreading into the nearby tissue toward other blood vessels. Furthermore, these white adipose tissue expansions remain reliant on multiple growth factors and cell-signaling molecules.¹⁰ Numerous investigations into stem cell grafting have found that implantation of ASCs in vivo within animal models does not result in the proliferation and differentiation of ASCs unless specific conditions have been met such as prior tissue injury or immunodeficiency.^10-12 These investigations support and expand on the inflammatory proliferation pathway. Thus, most of the true PTLs in the available research appear as de novo tumors and are more congruent with the inflammatory proliferation model.^1,2,4-6,8

Typical treatment of a PTL is surgical excision or liposuction depending on the pathology and size of the pseudolipoma. Biopsy examination prior to liposuction is critical for evaluation of liposarcoma and may help identify damage to Scarpa fascia. Recurrence of a PTL is rare regardless of treatment method; however, in a study of 31 PTL cases, only 6 were pathologically identified as PTLs without fibrous material.¹

Our patient experienced a blunt trauma to the buttocks and subsequently developed a PTL that was surgically excised and recurred within 3 months. Research surrounding the pathogenesis of the PTL has evolved from the theory of physical herniation of adipose tissue to an inflammatory differentiation of preadipocytes, but there is still much to learn about how and why it occurs and the mesenchymal differentiation following tissue injury.

To the Editor:

The posttraumatic pseudolipoma (PTL) is a painless localized mass comprised of unencapsulated adipose tissue that develops at the site of acute or prolonged blunt soft tissue trauma. It may be round or fusiform in shape and has areas of saponification leading to fat necrosis.¹ Posttraumatic pseudolipomas are 12 times more likely to occur in females, which may be attributed to sex-determined adipose tissue distribution or cosmetic concerns.² Most PTLs are found in areas of the body with high adiposity, including the hip, thigh, and gluteal regions.³ A patient history of a traumatic event resulting in a hematoma and a subsequent latent period of several months to years before the pseudolipoma formation occurs is common.^1,2,4-6

A 27-year-old woman presented to the family medicine clinic for examination of a deformity on the right buttock. She noticed a soft protruding mass months after landing on the buttocks and on top of a stick during routine physical training. Prior ultrasonography of the deformity proved unhelpful in determining the etiology. Physical examination revealed a protruding, 2-cm, flesh-colored mass on the right buttock intergluteal fold that was soft, compressible, and nontender (Figure 1). There was no capsule, nodule, loculation, or sinus tract. The patient underwent excisional resection with findings of benign-appearing unencapsulated adipose tissue (Figure 2). The wound was closed without difficulty. After several weeks, she had a well-healing scar without contour deficits of the buttocks. Two to 3 months after the initial repair, the patient presented to the family medicine clinic with recurrence of the fatty protrusion. She was referred for consultation and definitive management to a plastic surgeon but was lost to follow up.

In a systematic review of the literature to research pathogenesis theories, a PubMed search of articles indexed for MEDLINE using the terms trauma and pseudolipoma, lipoma, fat, or adipose yielded 45 citations, with only 10 publications addressing the pathology specific to pseudolipomas. Two leading theories of the pathogenesis of PTLs include the adipose herniation pathway and the inflammatory proliferation pathway.^4,5

Adipose tissue comprises fat lobules that are organized underneath the supportive elastic fascial layers. Injury from forces exceeding the fascial strength is the basis for the oldest pathogenesis theory. The adipose herniation theory suggests that fat lobules are displaced through the damaged septae, allowing for the development of an epidermal pseudolipoma at the site of blunt trauma.⁷ This theory has been supported by many case reports; however, more recent reports have identified a larger number of PTL cases that showed no identifiable disruptions in the fascia.^1,4,8

In 1997, the inflammatory proliferation theory began to gain attention. The theory describes how local tissue trauma leads to the release of inflammatory cytokines, which successively signals the development of preadipocytes or adipose tissue–derived stem cells (ASCs) into mature adipocytes.⁴ Most patients report a history of a hematoma in the area of pseudolipoma development, which strongly supports this newer theory. Studies exploring hematomas have found elevated levels of growth factors and inflammatory markers.^2,9 In particular, tumor necrosis factor α, peroxisome proliferator–activated receptor γ, vascular endothelial growth factor, and IL-6 and IL-8 may foster an environment in which adipogenic cells are both chemotaxed to the area of trauma and differentiated to white adipose tissue.^2,10

Despite addressing the role of the preadipocyte, the available research fails to address the general development of mesenchymal cells into the preadipocyte. White adipose tissue develops at sites of neovascularization and frequently has been observed spreading into the nearby tissue toward other blood vessels. Furthermore, these white adipose tissue expansions remain reliant on multiple growth factors and cell-signaling molecules.¹⁰ Numerous investigations into stem cell grafting have found that implantation of ASCs in vivo within animal models does not result in the proliferation and differentiation of ASCs unless specific conditions have been met such as prior tissue injury or immunodeficiency.^10-12 These investigations support and expand on the inflammatory proliferation pathway. Thus, most of the true PTLs in the available research appear as de novo tumors and are more congruent with the inflammatory proliferation model.^1,2,4-6,8

Typical treatment of a PTL is surgical excision or liposuction depending on the pathology and size of the pseudolipoma. Biopsy examination prior to liposuction is critical for evaluation of liposarcoma and may help identify damage to Scarpa fascia. Recurrence of a PTL is rare regardless of treatment method; however, in a study of 31 PTL cases, only 6 were pathologically identified as PTLs without fibrous material.¹

Our patient experienced a blunt trauma to the buttocks and subsequently developed a PTL that was surgically excised and recurred within 3 months. Research surrounding the pathogenesis of the PTL has evolved from the theory of physical herniation of adipose tissue to an inflammatory differentiation of preadipocytes, but there is still much to learn about how and why it occurs and the mesenchymal differentiation following tissue injury.

A less-than-1% decrease in weekly COVID-19 cases in children demonstrated continued stability in the pandemic situation as the nation heads into the holiday season.

“Over the past 6 weeks, weekly reported child cases have plateaued at an average of about 27,000 cases,” the American Academy of Pediatrics and the Children’s Hospital Association said in the latest edition of their joint COVID report.

New cases for the week of Nov. 11-17 totaled 27,899, down by 0.9% from the previous week and just 4 weeks removed from the lowest total of the year: 22,719 for Oct. 14-20. There have been just under 15 million cases of COVID-19 in children since the pandemic began, and children represent 18.3% of cases in all ages, the AAP and CHA reported.

Conditions look favorable for that plateau to continue, despite the upcoming holidays, White House COVID-19 coordinator Ashish Jha said recently. “We are in a very different place and we will remain in a different place,” Dr. Jha said, according to STAT News. “We are now at a point where I believe if you’re up to date on your vaccines, you have access to treatments ... there really should be no restrictions on people’s activities.”

One possible spoiler, an apparent spike in COVID-related hospitalizations in children we reported last week, seems to have been a false alarm. The rate of new admissions for Nov. 11, which preliminary data suggested was 0.48 per 100,000 population, has now been revised with more solid data to 0.20 per 100,000, according to the Centers for Disease Control and Prevention.

“We continue to monitor the recent increases in admissions among children. Some of these may be admissions with COVID-19, not because of COVID-19. Co-infections are being noted in our surveillance systems for hospitalizations among children; as much as 10% of admissions or higher have viruses codetected (RSV, influenza, enterovirus/rhinovirus, and other respiratory viruses),” a CDC spokesperson told this news organization.

For children aged 0-17 years, the current 7-day (Nov. 13-19) average number of new admissions with confirmed COVID is 129 per day, down from 147 for the previous 7-day average. Emergency department visits with diagnosed COVID, measured as a percentage of all ED visits, are largely holding steady. The latest 7-day averages available (Nov. 18) – 1.0% for children aged 0-11 years, 0.7% for 12- to 15-year-olds, and 0.8% in 16- to 17-year-olds – are the same or within a tenth of a percent of the rates recorded on Oct. 18, CDC data show.

New vaccinations for the week of Nov. 10-16 were down just slightly for children under age 5 years and for those aged 5-11 years, with a larger drop seen among 12- to 17-year-olds, the AAP said in its weekly vaccination report. So far, 7.9% of all children under age 5 have received at least one dose of COVID vaccine, as have 39.1% of 5 to 11-year-olds and 71.5% of those aged 12-17years, the CDC said on its COVID Data Tracker.
 

A less-than-1% decrease in weekly COVID-19 cases in children demonstrated continued stability in the pandemic situation as the nation heads into the holiday season.

“Over the past 6 weeks, weekly reported child cases have plateaued at an average of about 27,000 cases,” the American Academy of Pediatrics and the Children’s Hospital Association said in the latest edition of their joint COVID report.

New cases for the week of Nov. 11-17 totaled 27,899, down by 0.9% from the previous week and just 4 weeks removed from the lowest total of the year: 22,719 for Oct. 14-20. There have been just under 15 million cases of COVID-19 in children since the pandemic began, and children represent 18.3% of cases in all ages, the AAP and CHA reported.

Conditions look favorable for that plateau to continue, despite the upcoming holidays, White House COVID-19 coordinator Ashish Jha said recently. “We are in a very different place and we will remain in a different place,” Dr. Jha said, according to STAT News. “We are now at a point where I believe if you’re up to date on your vaccines, you have access to treatments ... there really should be no restrictions on people’s activities.”

One possible spoiler, an apparent spike in COVID-related hospitalizations in children we reported last week, seems to have been a false alarm. The rate of new admissions for Nov. 11, which preliminary data suggested was 0.48 per 100,000 population, has now been revised with more solid data to 0.20 per 100,000, according to the Centers for Disease Control and Prevention.

“We continue to monitor the recent increases in admissions among children. Some of these may be admissions with COVID-19, not because of COVID-19. Co-infections are being noted in our surveillance systems for hospitalizations among children; as much as 10% of admissions or higher have viruses codetected (RSV, influenza, enterovirus/rhinovirus, and other respiratory viruses),” a CDC spokesperson told this news organization.

For children aged 0-17 years, the current 7-day (Nov. 13-19) average number of new admissions with confirmed COVID is 129 per day, down from 147 for the previous 7-day average. Emergency department visits with diagnosed COVID, measured as a percentage of all ED visits, are largely holding steady. The latest 7-day averages available (Nov. 18) – 1.0% for children aged 0-11 years, 0.7% for 12- to 15-year-olds, and 0.8% in 16- to 17-year-olds – are the same or within a tenth of a percent of the rates recorded on Oct. 18, CDC data show.

New vaccinations for the week of Nov. 10-16 were down just slightly for children under age 5 years and for those aged 5-11 years, with a larger drop seen among 12- to 17-year-olds, the AAP said in its weekly vaccination report. So far, 7.9% of all children under age 5 have received at least one dose of COVID vaccine, as have 39.1% of 5 to 11-year-olds and 71.5% of those aged 12-17years, the CDC said on its COVID Data Tracker.
 

A less-than-1% decrease in weekly COVID-19 cases in children demonstrated continued stability in the pandemic situation as the nation heads into the holiday season.

“Over the past 6 weeks, weekly reported child cases have plateaued at an average of about 27,000 cases,” the American Academy of Pediatrics and the Children’s Hospital Association said in the latest edition of their joint COVID report.

New cases for the week of Nov. 11-17 totaled 27,899, down by 0.9% from the previous week and just 4 weeks removed from the lowest total of the year: 22,719 for Oct. 14-20. There have been just under 15 million cases of COVID-19 in children since the pandemic began, and children represent 18.3% of cases in all ages, the AAP and CHA reported.

Conditions look favorable for that plateau to continue, despite the upcoming holidays, White House COVID-19 coordinator Ashish Jha said recently. “We are in a very different place and we will remain in a different place,” Dr. Jha said, according to STAT News. “We are now at a point where I believe if you’re up to date on your vaccines, you have access to treatments ... there really should be no restrictions on people’s activities.”

One possible spoiler, an apparent spike in COVID-related hospitalizations in children we reported last week, seems to have been a false alarm. The rate of new admissions for Nov. 11, which preliminary data suggested was 0.48 per 100,000 population, has now been revised with more solid data to 0.20 per 100,000, according to the Centers for Disease Control and Prevention.

“We continue to monitor the recent increases in admissions among children. Some of these may be admissions with COVID-19, not because of COVID-19. Co-infections are being noted in our surveillance systems for hospitalizations among children; as much as 10% of admissions or higher have viruses codetected (RSV, influenza, enterovirus/rhinovirus, and other respiratory viruses),” a CDC spokesperson told this news organization.

For children aged 0-17 years, the current 7-day (Nov. 13-19) average number of new admissions with confirmed COVID is 129 per day, down from 147 for the previous 7-day average. Emergency department visits with diagnosed COVID, measured as a percentage of all ED visits, are largely holding steady. The latest 7-day averages available (Nov. 18) – 1.0% for children aged 0-11 years, 0.7% for 12- to 15-year-olds, and 0.8% in 16- to 17-year-olds – are the same or within a tenth of a percent of the rates recorded on Oct. 18, CDC data show.

New vaccinations for the week of Nov. 10-16 were down just slightly for children under age 5 years and for those aged 5-11 years, with a larger drop seen among 12- to 17-year-olds, the AAP said in its weekly vaccination report. So far, 7.9% of all children under age 5 have received at least one dose of COVID vaccine, as have 39.1% of 5 to 11-year-olds and 71.5% of those aged 12-17years, the CDC said on its COVID Data Tracker.
 

Rates of youth suicides at the county level increased as mental health professional shortages increased, based on data from more than 5,000 youth suicides across all counties in the United States.

Suicide remains the second leading cause of death among adolescents in the United States, and shortages of pediatric mental health providers are well known, but the association between mental health workforce shortages and youth suicides at the local level has not been well studied, Jennifer A. Hoffmann, MD, of Northwestern University, Chicago, and colleagues wrote.

Previous studies have shown few or no child psychiatrists or child-focused mental health professionals in most counties across the United States, and shortages are more likely in rural and high-poverty counties, the researchers noted.

In a cross-sectional study published in JAMA Pediatrics, the researchers reviewed all youth suicide data from January 2015 to Dec. 31, 2016 using the Centers for Disease Control and Prevention’s Compressed Mortality File. They used a multivariate binomial regression model to examine the association between youth suicide rates and the presence or absence of mental health care. Mental health care shortages were based on data from the U.S. Health Resources and Services Administration’s assessment of the number of mental health professionals relative to the country population and the availability of nearby services. Areas identified as having shortages were designated as Health Professional Shortage Areas (HPSAs) and scored on a severity level of 0-25, with higher scores indicating greater shortages. Approximately two-thirds (67.6%) of the 3,133 counties included in the study met criteria for mental health workforce shortage areas.

The researchers identified 5,034 suicides in youth aged 5-19 years during the study period, for an annual rate of 3.99 per 100,000 individuals. Of these, 72.8% were male and 68.2% were non-Hispanic White.

Overall, a county designation of mental health care shortage was significantly associated with an increased rate of youth suicide (adjusted incidence rate ratio, 1.16) and also increased rate of youth firearm suicide (aIRR, 1.27) after controlling for county and socioeconomic characteristics including the presence of a children’s mental health hospital, the percentage of children without health insurance, median household income, and racial makeup of the county.

The adjusted youth suicide rate increased by 4% for every 1-point increase in the HPSA score in counties with designated mental health workforce shortages.

The adjusted youth suicide rates were higher in counties with a lower median household income, and youth suicides increased with increases in the percentages of uninsured children, the researchers wrote.

“Reducing poverty, addressing social determinants of health, and improving insurance coverage may be considered as components of a multipronged societal strategy to improve child health and reduce youth suicides,” they said. “Efforts are needed to enhance the mental health professional workforce to match current levels of need.” Possible strategies to increase the pediatric mental health workforce may include improving reimbursement and integrating mental health care into primary care and schools by expanding telehealth services.

The study findings were limited by several factors including the potential misclassification of demographics or cause of death, the researchers noted. Other limitations included the inability to assess actual use of mental health services or firearm ownership in a household, and the possible differences between county-level associations and those of a city, neighborhood, or individual.

However, the results indicate that mental health professional workforce shortages were associated with increased youth suicide rates, and the data may inform local-level suicide prevention efforts, they concluded.
 

Data support the need for early intervention

“It was very important to conduct this study at this time because mental health problems, to include suicidal ideation, continue to increase in adolescents,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “This study reinforces the immense import of sufficient mental health workforce to mitigate this increasing risk of suicide in adolescents.”

Dr. Loper said: “I believe that early intervention, or consistent access to mental health services, can go a very long way in preventing suicide in adolescents.

“I think the primary implications of this study are more relevant at the systems level, and reinforce the necessity of clinicians advocating for policies that address mental health workforce shortages in counties that are underserved,” he added.

However, “One primary barrier to increasing the number of mental health professionals at a local level, and specifically the number of child psychiatrists, is that demand is currently outpacing supply,” said Dr. Loper, a pediatrician and psychiatrist who was not involved in the study. “As the study authors cite, increasing telepsychiatry services and increasing mental health workforce specifically in the primary care setting may help offset these deficiencies,” he noted. Looking ahead, primary prevention of mental health problems by grassroots efforts is vital to stopping the trend in increased youth suicides and more mental health professionals are needed to mitigate the phenomenon of isolation and the degradation of community constructs.

As for additional research, Dr. Loper agreed with the study authors comments on the need for “more granular data” to better understand the correlation between mental health workforce and suicide in adolescents. “Data that captures city or neighborhood statistics related to mental health workforce and adolescent suicide could go a long way in our efforts to continue to better understand this very important correlation.”

The study was supported by an Academic Pediatric Association Young Investigator Award. Dr. Hoffmann disclosed research funding from the U.S. Agency for Healthcare Research and Quality unrelated to the current study. Dr. Loper had no financial conflicts to disclose.

Rates of youth suicides at the county level increased as mental health professional shortages increased, based on data from more than 5,000 youth suicides across all counties in the United States.

Suicide remains the second leading cause of death among adolescents in the United States, and shortages of pediatric mental health providers are well known, but the association between mental health workforce shortages and youth suicides at the local level has not been well studied, Jennifer A. Hoffmann, MD, of Northwestern University, Chicago, and colleagues wrote.

Previous studies have shown few or no child psychiatrists or child-focused mental health professionals in most counties across the United States, and shortages are more likely in rural and high-poverty counties, the researchers noted.

In a cross-sectional study published in JAMA Pediatrics, the researchers reviewed all youth suicide data from January 2015 to Dec. 31, 2016 using the Centers for Disease Control and Prevention’s Compressed Mortality File. They used a multivariate binomial regression model to examine the association between youth suicide rates and the presence or absence of mental health care. Mental health care shortages were based on data from the U.S. Health Resources and Services Administration’s assessment of the number of mental health professionals relative to the country population and the availability of nearby services. Areas identified as having shortages were designated as Health Professional Shortage Areas (HPSAs) and scored on a severity level of 0-25, with higher scores indicating greater shortages. Approximately two-thirds (67.6%) of the 3,133 counties included in the study met criteria for mental health workforce shortage areas.

The researchers identified 5,034 suicides in youth aged 5-19 years during the study period, for an annual rate of 3.99 per 100,000 individuals. Of these, 72.8% were male and 68.2% were non-Hispanic White.

Overall, a county designation of mental health care shortage was significantly associated with an increased rate of youth suicide (adjusted incidence rate ratio, 1.16) and also increased rate of youth firearm suicide (aIRR, 1.27) after controlling for county and socioeconomic characteristics including the presence of a children’s mental health hospital, the percentage of children without health insurance, median household income, and racial makeup of the county.

The adjusted youth suicide rate increased by 4% for every 1-point increase in the HPSA score in counties with designated mental health workforce shortages.

The adjusted youth suicide rates were higher in counties with a lower median household income, and youth suicides increased with increases in the percentages of uninsured children, the researchers wrote.

“Reducing poverty, addressing social determinants of health, and improving insurance coverage may be considered as components of a multipronged societal strategy to improve child health and reduce youth suicides,” they said. “Efforts are needed to enhance the mental health professional workforce to match current levels of need.” Possible strategies to increase the pediatric mental health workforce may include improving reimbursement and integrating mental health care into primary care and schools by expanding telehealth services.

The study findings were limited by several factors including the potential misclassification of demographics or cause of death, the researchers noted. Other limitations included the inability to assess actual use of mental health services or firearm ownership in a household, and the possible differences between county-level associations and those of a city, neighborhood, or individual.

However, the results indicate that mental health professional workforce shortages were associated with increased youth suicide rates, and the data may inform local-level suicide prevention efforts, they concluded.
 

Data support the need for early intervention

“It was very important to conduct this study at this time because mental health problems, to include suicidal ideation, continue to increase in adolescents,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “This study reinforces the immense import of sufficient mental health workforce to mitigate this increasing risk of suicide in adolescents.”

Dr. Loper said: “I believe that early intervention, or consistent access to mental health services, can go a very long way in preventing suicide in adolescents.

“I think the primary implications of this study are more relevant at the systems level, and reinforce the necessity of clinicians advocating for policies that address mental health workforce shortages in counties that are underserved,” he added.

However, “One primary barrier to increasing the number of mental health professionals at a local level, and specifically the number of child psychiatrists, is that demand is currently outpacing supply,” said Dr. Loper, a pediatrician and psychiatrist who was not involved in the study. “As the study authors cite, increasing telepsychiatry services and increasing mental health workforce specifically in the primary care setting may help offset these deficiencies,” he noted. Looking ahead, primary prevention of mental health problems by grassroots efforts is vital to stopping the trend in increased youth suicides and more mental health professionals are needed to mitigate the phenomenon of isolation and the degradation of community constructs.

As for additional research, Dr. Loper agreed with the study authors comments on the need for “more granular data” to better understand the correlation between mental health workforce and suicide in adolescents. “Data that captures city or neighborhood statistics related to mental health workforce and adolescent suicide could go a long way in our efforts to continue to better understand this very important correlation.”

The study was supported by an Academic Pediatric Association Young Investigator Award. Dr. Hoffmann disclosed research funding from the U.S. Agency for Healthcare Research and Quality unrelated to the current study. Dr. Loper had no financial conflicts to disclose.

Rates of youth suicides at the county level increased as mental health professional shortages increased, based on data from more than 5,000 youth suicides across all counties in the United States.

Suicide remains the second leading cause of death among adolescents in the United States, and shortages of pediatric mental health providers are well known, but the association between mental health workforce shortages and youth suicides at the local level has not been well studied, Jennifer A. Hoffmann, MD, of Northwestern University, Chicago, and colleagues wrote.

Previous studies have shown few or no child psychiatrists or child-focused mental health professionals in most counties across the United States, and shortages are more likely in rural and high-poverty counties, the researchers noted.

In a cross-sectional study published in JAMA Pediatrics, the researchers reviewed all youth suicide data from January 2015 to Dec. 31, 2016 using the Centers for Disease Control and Prevention’s Compressed Mortality File. They used a multivariate binomial regression model to examine the association between youth suicide rates and the presence or absence of mental health care. Mental health care shortages were based on data from the U.S. Health Resources and Services Administration’s assessment of the number of mental health professionals relative to the country population and the availability of nearby services. Areas identified as having shortages were designated as Health Professional Shortage Areas (HPSAs) and scored on a severity level of 0-25, with higher scores indicating greater shortages. Approximately two-thirds (67.6%) of the 3,133 counties included in the study met criteria for mental health workforce shortage areas.

The researchers identified 5,034 suicides in youth aged 5-19 years during the study period, for an annual rate of 3.99 per 100,000 individuals. Of these, 72.8% were male and 68.2% were non-Hispanic White.

Overall, a county designation of mental health care shortage was significantly associated with an increased rate of youth suicide (adjusted incidence rate ratio, 1.16) and also increased rate of youth firearm suicide (aIRR, 1.27) after controlling for county and socioeconomic characteristics including the presence of a children’s mental health hospital, the percentage of children without health insurance, median household income, and racial makeup of the county.

The adjusted youth suicide rate increased by 4% for every 1-point increase in the HPSA score in counties with designated mental health workforce shortages.

The adjusted youth suicide rates were higher in counties with a lower median household income, and youth suicides increased with increases in the percentages of uninsured children, the researchers wrote.

“Reducing poverty, addressing social determinants of health, and improving insurance coverage may be considered as components of a multipronged societal strategy to improve child health and reduce youth suicides,” they said. “Efforts are needed to enhance the mental health professional workforce to match current levels of need.” Possible strategies to increase the pediatric mental health workforce may include improving reimbursement and integrating mental health care into primary care and schools by expanding telehealth services.

The study findings were limited by several factors including the potential misclassification of demographics or cause of death, the researchers noted. Other limitations included the inability to assess actual use of mental health services or firearm ownership in a household, and the possible differences between county-level associations and those of a city, neighborhood, or individual.

However, the results indicate that mental health professional workforce shortages were associated with increased youth suicide rates, and the data may inform local-level suicide prevention efforts, they concluded.
 

Data support the need for early intervention

“It was very important to conduct this study at this time because mental health problems, to include suicidal ideation, continue to increase in adolescents,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “This study reinforces the immense import of sufficient mental health workforce to mitigate this increasing risk of suicide in adolescents.”

Dr. Loper said: “I believe that early intervention, or consistent access to mental health services, can go a very long way in preventing suicide in adolescents.

“I think the primary implications of this study are more relevant at the systems level, and reinforce the necessity of clinicians advocating for policies that address mental health workforce shortages in counties that are underserved,” he added.

However, “One primary barrier to increasing the number of mental health professionals at a local level, and specifically the number of child psychiatrists, is that demand is currently outpacing supply,” said Dr. Loper, a pediatrician and psychiatrist who was not involved in the study. “As the study authors cite, increasing telepsychiatry services and increasing mental health workforce specifically in the primary care setting may help offset these deficiencies,” he noted. Looking ahead, primary prevention of mental health problems by grassroots efforts is vital to stopping the trend in increased youth suicides and more mental health professionals are needed to mitigate the phenomenon of isolation and the degradation of community constructs.

As for additional research, Dr. Loper agreed with the study authors comments on the need for “more granular data” to better understand the correlation between mental health workforce and suicide in adolescents. “Data that captures city or neighborhood statistics related to mental health workforce and adolescent suicide could go a long way in our efforts to continue to better understand this very important correlation.”

The study was supported by an Academic Pediatric Association Young Investigator Award. Dr. Hoffmann disclosed research funding from the U.S. Agency for Healthcare Research and Quality unrelated to the current study. Dr. Loper had no financial conflicts to disclose.

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m².

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m².

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m².

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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