A “high-intensity-care” strategy based on early and rapid uptitration of guideline-directed meds improves postdischarge clinical outcomes for patients hospitalized with decompensated heart failure (HF), suggest topline results from a randomized trial.

The STRONG-HF study was halted early on recommendation from its data safety monitoring board after an interim analysis suggested the high-intensity-care strategy significantly cut risk of death or HF readmission, compared with a standard-of-care approach.

The trial termination was announced  in a press release from one of its sponsors, The Heart Initiative, a nonprofit organization. STRONG-HF was also supported by Roche Diagnostics.

The early termination was based on interim data from the approximately 1,000 patients, out of an estimated planned enrollment of 1,800, who had been followed for at least 90 days. The study’s actual primary endpoint had been defined by death or HF readmission at 6 months.

The announcement did not include outcomes data or P values, or any other indication of the magnitude of benefit from the high-intensity-care approach.

Patients in STRONG-HF who had been assigned to a high-intensity-care strategy had been started in-hospital on a beta blocker, a renin-angiotensin system inhibitor (RASi), and a mineralocorticoid receptor blocker (MRA) with dosages uptitrated at least halfway by the time of discharge.

The meds were uptitrated fully within 2 weeks of discharge guided by clinical and biomarker assessments, especially natriuretic peptides, at frequent postdischarge visits, the press release states.

Patients conducted “safety visits 1 week after any uptitration and follow-up visits at 6 weeks and 3 months,” the announcement notes. “At each visit, patients were assessed by physical examination for congestion and blood tests, including NT-proBNP measurements.”

The “full STRONG-HF trial results” are scheduled for presentation at the American Heart Association annual scientific sessions, the announcement states.

STRONG-HF is sponsored by The Heart Initiative and Roche Diagnostics.

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

A “high-intensity-care” strategy based on early and rapid uptitration of guideline-directed meds improves postdischarge clinical outcomes for patients hospitalized with decompensated heart failure (HF), suggest topline results from a randomized trial.

The STRONG-HF study was halted early on recommendation from its data safety monitoring board after an interim analysis suggested the high-intensity-care strategy significantly cut risk of death or HF readmission, compared with a standard-of-care approach.

The trial termination was announced  in a press release from one of its sponsors, The Heart Initiative, a nonprofit organization. STRONG-HF was also supported by Roche Diagnostics.

The early termination was based on interim data from the approximately 1,000 patients, out of an estimated planned enrollment of 1,800, who had been followed for at least 90 days. The study’s actual primary endpoint had been defined by death or HF readmission at 6 months.

The announcement did not include outcomes data or P values, or any other indication of the magnitude of benefit from the high-intensity-care approach.

Patients in STRONG-HF who had been assigned to a high-intensity-care strategy had been started in-hospital on a beta blocker, a renin-angiotensin system inhibitor (RASi), and a mineralocorticoid receptor blocker (MRA) with dosages uptitrated at least halfway by the time of discharge.

The meds were uptitrated fully within 2 weeks of discharge guided by clinical and biomarker assessments, especially natriuretic peptides, at frequent postdischarge visits, the press release states.

Patients conducted “safety visits 1 week after any uptitration and follow-up visits at 6 weeks and 3 months,” the announcement notes. “At each visit, patients were assessed by physical examination for congestion and blood tests, including NT-proBNP measurements.”

The “full STRONG-HF trial results” are scheduled for presentation at the American Heart Association annual scientific sessions, the announcement states.

STRONG-HF is sponsored by The Heart Initiative and Roche Diagnostics.

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

A “high-intensity-care” strategy based on early and rapid uptitration of guideline-directed meds improves postdischarge clinical outcomes for patients hospitalized with decompensated heart failure (HF), suggest topline results from a randomized trial.

The STRONG-HF study was halted early on recommendation from its data safety monitoring board after an interim analysis suggested the high-intensity-care strategy significantly cut risk of death or HF readmission, compared with a standard-of-care approach.

The trial termination was announced  in a press release from one of its sponsors, The Heart Initiative, a nonprofit organization. STRONG-HF was also supported by Roche Diagnostics.

The early termination was based on interim data from the approximately 1,000 patients, out of an estimated planned enrollment of 1,800, who had been followed for at least 90 days. The study’s actual primary endpoint had been defined by death or HF readmission at 6 months.

The announcement did not include outcomes data or P values, or any other indication of the magnitude of benefit from the high-intensity-care approach.

Patients in STRONG-HF who had been assigned to a high-intensity-care strategy had been started in-hospital on a beta blocker, a renin-angiotensin system inhibitor (RASi), and a mineralocorticoid receptor blocker (MRA) with dosages uptitrated at least halfway by the time of discharge.

The meds were uptitrated fully within 2 weeks of discharge guided by clinical and biomarker assessments, especially natriuretic peptides, at frequent postdischarge visits, the press release states.

Patients conducted “safety visits 1 week after any uptitration and follow-up visits at 6 weeks and 3 months,” the announcement notes. “At each visit, patients were assessed by physical examination for congestion and blood tests, including NT-proBNP measurements.”

The “full STRONG-HF trial results” are scheduled for presentation at the American Heart Association annual scientific sessions, the announcement states.

STRONG-HF is sponsored by The Heart Initiative and Roche Diagnostics.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

Athletes with mild hypertrophic cardiomyopathy (HCM) at low risk of sudden cardiac death (SCD) can safely continue to exercise at competitive levels, a retrospective study suggests.

During a mean follow-up of 4.5 years, athletes who continued to engage in high-intensity competitive sports after a mild HCM diagnosis were free of cardiac symptoms, and there were no deaths, incidents of sustained ventricular tachycardia or syncope, or changes in cardiac electrical, structural, or functional phenotypes.

Pavel1964/iStock/Getty Images

“This study supports emerging evidence that HCM individuals with a low-risk profile and mild hypertrophy may engage in vigorous exercise and competitive sport,” Sanjay Sharma, MD, of St. George’s University of London, said in an interview. Current guidelines from the European Society of Cardiology and the American College of Cardiology support a more liberal approach to exercise for these individuals.

That said, he added, “it is important to emphasize that our cohort consisted of a group of adult competitive athletes who had probably been competing for several years before the diagnosis was made and therefore represented a self-selected, low-risk cohort. It is difficult to extrapolate this data to adolescent athletes, who appear to be more vulnerable to exercise-related SCD from HCM.”

The study was published online in the Journal of the American College of Cardiology.
 

Vigorous exercise OK for some

Dr. Sharma and colleagues analyzed data from 53 athletes with HCM who continued to participate in competitive sports. The mean age was 39 years, 98% were men, and 72% were White. About half (53%) competed as professionals, and were most commonly engaged in cycling, football, running, and rugby.

Participants underwent 6-12 monthly assessments that included electrocardiograms, echocardiograms, cardiopulmonary exercise testing, Holter monitoring (≥ 24 hours), and cardiac magnetic resonance imaging. A majority (64.2%) were evaluated because of an abnormal electrocardiograms, and one presented with an incidental abnormal echocardiogram.

About a quarter (24.5%) were symptomatic and 5 (9.4%) were identified on family screening. Eight (15%) had a family history of HCM, and six (11.3%) of SCD.

At the baseline evaluation, all athletes had a “low” ESC 5-year SCD risk score for HCM (1.9% ± 0.9%). None had syncope. Mean peak VO₂ was 40.7 ± 6.8 mL/kg per minute.

The mean left ventricular wall thickness was 14.6 ± 2.3 mm; all had normal LV systolic and diastolic function and no LV outflow tract obstruction at rest or on provocation testing. In addition, none had an LV apical aneurysm.

Twenty-two (41%) showed late gadolinium enhancement on baseline cardiac magnetic resonance imaging.

A total of 19 participants underwent genotyping; 4 (21.1%) had a pathogenic/likely pathogenic sarcomeric variant. None took cardiovascular medication or had an implantable cardioverter defibrillator (ICD).

During a mean follow-up of 4.5 years, all participants continued to exercise at the same level as before their diagnosis; none underwent detraining. All stayed free of cardiac symptoms, and there were no deaths, sustained ventricular tachycardia episodes, or syncope.

Four demonstrated new, nonsustained ventricular tachycardia (NSVT) during follow-up, one of whom underwent ICD implantation because of an increased risk score and subsequently moderated exercise levels.

One participant had a 30-second atrial fibrillation (AFib) episode lasting longer than 30 seconds, started on a beta-blocker and oral anticoagulation, and also moderated exercise levels.

The event rate was 2.1% per year for asymptomatic arrhythmias (NSVT and AFib). No changes were observed in the cardiac electrical, structural, or functional phenotype during follow-up.

Dr. Sharma and colleagues stated: “Our sample size is small; however, it is nearly double the size of a previously studied Italian athletic cohort, and one-half were professional athletes. Furthermore, 17% of our cohort comprised Black athletes who are perceived to be at higher risk of SCD than White athletes.”

Daniele Massera, MD, assistant professor in the HCM program, department of medicine, Charney Division of Cardiology, New York University Langone Health, said in an interview: “Of note, these were athletes/patients at the very low end of phenotypic severity of HCM. ... It is also notable that diastolic function was normal in all of them, an uncommon finding in patients with HCM.”

Like Dr. Sharma, he said the findings are in line with recent guidelines, and cautioned: “This small study applies only to a very small subset of patients who are being evaluated at specialized HCM programs: asymptomatic male individuals who have mild, low-risk HCM and are on no medicines.

“The findings cannot be generalized to the population of symptomatic individuals with (or without) outflow obstruction, more severe hypertrophy, and who have ICDs and/or take medication for symptoms, nor to younger patients or adolescents, who may be at higher risk for adverse outcomes,” he concluded.
 

Individualized approach urged

Dr. Sharma was a coauthor of the recent article challenging the traditional restrictive approach to exercise for athletes diagnosed with HCM and other inherited cardiovascular diseases. The article suggested that individualized recommendations, taking risks into consideration, can help guide those who want to exercise or participate in competitive sports.

Dr. Sharma also is a coauthor of a 6-month follow-up to the SAFE-HCM study, which compared the effects of a supervised 12-week high-intensity exercise program to usual care in low-risk individuals with HCM (mean age, 45.7). 

In the 6-month follow-up study, published as an abstract in the European Journal of Preventive Cardiology 2021 supplement, “exercising individuals had improved functional capacity and atherosclerotic risk profile and there were no differences in the composite safety outcomes [cardiovascular death, cardiac arrest, device therapy, exercise-induced syncope, sustained VT, NSVT, or sustained atrial arrhythmias] between exercising individuals and usual care individuals,” Dr. Sharma said.

The full study will soon be ready to submit for publication, he added.

No commercial funding or relevant conflicts of interest were disclosed.

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

Athletes with mild hypertrophic cardiomyopathy (HCM) at low risk of sudden cardiac death (SCD) can safely continue to exercise at competitive levels, a retrospective study suggests.

During a mean follow-up of 4.5 years, athletes who continued to engage in high-intensity competitive sports after a mild HCM diagnosis were free of cardiac symptoms, and there were no deaths, incidents of sustained ventricular tachycardia or syncope, or changes in cardiac electrical, structural, or functional phenotypes.

Pavel1964/iStock/Getty Images

“This study supports emerging evidence that HCM individuals with a low-risk profile and mild hypertrophy may engage in vigorous exercise and competitive sport,” Sanjay Sharma, MD, of St. George’s University of London, said in an interview. Current guidelines from the European Society of Cardiology and the American College of Cardiology support a more liberal approach to exercise for these individuals.

That said, he added, “it is important to emphasize that our cohort consisted of a group of adult competitive athletes who had probably been competing for several years before the diagnosis was made and therefore represented a self-selected, low-risk cohort. It is difficult to extrapolate this data to adolescent athletes, who appear to be more vulnerable to exercise-related SCD from HCM.”

The study was published online in the Journal of the American College of Cardiology.
 

Vigorous exercise OK for some

Dr. Sharma and colleagues analyzed data from 53 athletes with HCM who continued to participate in competitive sports. The mean age was 39 years, 98% were men, and 72% were White. About half (53%) competed as professionals, and were most commonly engaged in cycling, football, running, and rugby.

Participants underwent 6-12 monthly assessments that included electrocardiograms, echocardiograms, cardiopulmonary exercise testing, Holter monitoring (≥ 24 hours), and cardiac magnetic resonance imaging. A majority (64.2%) were evaluated because of an abnormal electrocardiograms, and one presented with an incidental abnormal echocardiogram.

About a quarter (24.5%) were symptomatic and 5 (9.4%) were identified on family screening. Eight (15%) had a family history of HCM, and six (11.3%) of SCD.

At the baseline evaluation, all athletes had a “low” ESC 5-year SCD risk score for HCM (1.9% ± 0.9%). None had syncope. Mean peak VO₂ was 40.7 ± 6.8 mL/kg per minute.

The mean left ventricular wall thickness was 14.6 ± 2.3 mm; all had normal LV systolic and diastolic function and no LV outflow tract obstruction at rest or on provocation testing. In addition, none had an LV apical aneurysm.

Twenty-two (41%) showed late gadolinium enhancement on baseline cardiac magnetic resonance imaging.

A total of 19 participants underwent genotyping; 4 (21.1%) had a pathogenic/likely pathogenic sarcomeric variant. None took cardiovascular medication or had an implantable cardioverter defibrillator (ICD).

During a mean follow-up of 4.5 years, all participants continued to exercise at the same level as before their diagnosis; none underwent detraining. All stayed free of cardiac symptoms, and there were no deaths, sustained ventricular tachycardia episodes, or syncope.

Four demonstrated new, nonsustained ventricular tachycardia (NSVT) during follow-up, one of whom underwent ICD implantation because of an increased risk score and subsequently moderated exercise levels.

One participant had a 30-second atrial fibrillation (AFib) episode lasting longer than 30 seconds, started on a beta-blocker and oral anticoagulation, and also moderated exercise levels.

The event rate was 2.1% per year for asymptomatic arrhythmias (NSVT and AFib). No changes were observed in the cardiac electrical, structural, or functional phenotype during follow-up.

Dr. Sharma and colleagues stated: “Our sample size is small; however, it is nearly double the size of a previously studied Italian athletic cohort, and one-half were professional athletes. Furthermore, 17% of our cohort comprised Black athletes who are perceived to be at higher risk of SCD than White athletes.”

Daniele Massera, MD, assistant professor in the HCM program, department of medicine, Charney Division of Cardiology, New York University Langone Health, said in an interview: “Of note, these were athletes/patients at the very low end of phenotypic severity of HCM. ... It is also notable that diastolic function was normal in all of them, an uncommon finding in patients with HCM.”

Like Dr. Sharma, he said the findings are in line with recent guidelines, and cautioned: “This small study applies only to a very small subset of patients who are being evaluated at specialized HCM programs: asymptomatic male individuals who have mild, low-risk HCM and are on no medicines.

“The findings cannot be generalized to the population of symptomatic individuals with (or without) outflow obstruction, more severe hypertrophy, and who have ICDs and/or take medication for symptoms, nor to younger patients or adolescents, who may be at higher risk for adverse outcomes,” he concluded.
 

Individualized approach urged

Dr. Sharma was a coauthor of the recent article challenging the traditional restrictive approach to exercise for athletes diagnosed with HCM and other inherited cardiovascular diseases. The article suggested that individualized recommendations, taking risks into consideration, can help guide those who want to exercise or participate in competitive sports.

Dr. Sharma also is a coauthor of a 6-month follow-up to the SAFE-HCM study, which compared the effects of a supervised 12-week high-intensity exercise program to usual care in low-risk individuals with HCM (mean age, 45.7). 

In the 6-month follow-up study, published as an abstract in the European Journal of Preventive Cardiology 2021 supplement, “exercising individuals had improved functional capacity and atherosclerotic risk profile and there were no differences in the composite safety outcomes [cardiovascular death, cardiac arrest, device therapy, exercise-induced syncope, sustained VT, NSVT, or sustained atrial arrhythmias] between exercising individuals and usual care individuals,” Dr. Sharma said.

The full study will soon be ready to submit for publication, he added.

No commercial funding or relevant conflicts of interest were disclosed.

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

Athletes with mild hypertrophic cardiomyopathy (HCM) at low risk of sudden cardiac death (SCD) can safely continue to exercise at competitive levels, a retrospective study suggests.

During a mean follow-up of 4.5 years, athletes who continued to engage in high-intensity competitive sports after a mild HCM diagnosis were free of cardiac symptoms, and there were no deaths, incidents of sustained ventricular tachycardia or syncope, or changes in cardiac electrical, structural, or functional phenotypes.

Pavel1964/iStock/Getty Images

“This study supports emerging evidence that HCM individuals with a low-risk profile and mild hypertrophy may engage in vigorous exercise and competitive sport,” Sanjay Sharma, MD, of St. George’s University of London, said in an interview. Current guidelines from the European Society of Cardiology and the American College of Cardiology support a more liberal approach to exercise for these individuals.

That said, he added, “it is important to emphasize that our cohort consisted of a group of adult competitive athletes who had probably been competing for several years before the diagnosis was made and therefore represented a self-selected, low-risk cohort. It is difficult to extrapolate this data to adolescent athletes, who appear to be more vulnerable to exercise-related SCD from HCM.”

The study was published online in the Journal of the American College of Cardiology.
 

Vigorous exercise OK for some

Dr. Sharma and colleagues analyzed data from 53 athletes with HCM who continued to participate in competitive sports. The mean age was 39 years, 98% were men, and 72% were White. About half (53%) competed as professionals, and were most commonly engaged in cycling, football, running, and rugby.

Participants underwent 6-12 monthly assessments that included electrocardiograms, echocardiograms, cardiopulmonary exercise testing, Holter monitoring (≥ 24 hours), and cardiac magnetic resonance imaging. A majority (64.2%) were evaluated because of an abnormal electrocardiograms, and one presented with an incidental abnormal echocardiogram.

About a quarter (24.5%) were symptomatic and 5 (9.4%) were identified on family screening. Eight (15%) had a family history of HCM, and six (11.3%) of SCD.

At the baseline evaluation, all athletes had a “low” ESC 5-year SCD risk score for HCM (1.9% ± 0.9%). None had syncope. Mean peak VO₂ was 40.7 ± 6.8 mL/kg per minute.

The mean left ventricular wall thickness was 14.6 ± 2.3 mm; all had normal LV systolic and diastolic function and no LV outflow tract obstruction at rest or on provocation testing. In addition, none had an LV apical aneurysm.

Twenty-two (41%) showed late gadolinium enhancement on baseline cardiac magnetic resonance imaging.

A total of 19 participants underwent genotyping; 4 (21.1%) had a pathogenic/likely pathogenic sarcomeric variant. None took cardiovascular medication or had an implantable cardioverter defibrillator (ICD).

During a mean follow-up of 4.5 years, all participants continued to exercise at the same level as before their diagnosis; none underwent detraining. All stayed free of cardiac symptoms, and there were no deaths, sustained ventricular tachycardia episodes, or syncope.

Four demonstrated new, nonsustained ventricular tachycardia (NSVT) during follow-up, one of whom underwent ICD implantation because of an increased risk score and subsequently moderated exercise levels.

One participant had a 30-second atrial fibrillation (AFib) episode lasting longer than 30 seconds, started on a beta-blocker and oral anticoagulation, and also moderated exercise levels.

The event rate was 2.1% per year for asymptomatic arrhythmias (NSVT and AFib). No changes were observed in the cardiac electrical, structural, or functional phenotype during follow-up.

Dr. Sharma and colleagues stated: “Our sample size is small; however, it is nearly double the size of a previously studied Italian athletic cohort, and one-half were professional athletes. Furthermore, 17% of our cohort comprised Black athletes who are perceived to be at higher risk of SCD than White athletes.”

Daniele Massera, MD, assistant professor in the HCM program, department of medicine, Charney Division of Cardiology, New York University Langone Health, said in an interview: “Of note, these were athletes/patients at the very low end of phenotypic severity of HCM. ... It is also notable that diastolic function was normal in all of them, an uncommon finding in patients with HCM.”

Like Dr. Sharma, he said the findings are in line with recent guidelines, and cautioned: “This small study applies only to a very small subset of patients who are being evaluated at specialized HCM programs: asymptomatic male individuals who have mild, low-risk HCM and are on no medicines.

“The findings cannot be generalized to the population of symptomatic individuals with (or without) outflow obstruction, more severe hypertrophy, and who have ICDs and/or take medication for symptoms, nor to younger patients or adolescents, who may be at higher risk for adverse outcomes,” he concluded.
 

Individualized approach urged

Dr. Sharma was a coauthor of the recent article challenging the traditional restrictive approach to exercise for athletes diagnosed with HCM and other inherited cardiovascular diseases. The article suggested that individualized recommendations, taking risks into consideration, can help guide those who want to exercise or participate in competitive sports.

Dr. Sharma also is a coauthor of a 6-month follow-up to the SAFE-HCM study, which compared the effects of a supervised 12-week high-intensity exercise program to usual care in low-risk individuals with HCM (mean age, 45.7). 

In the 6-month follow-up study, published as an abstract in the European Journal of Preventive Cardiology 2021 supplement, “exercising individuals had improved functional capacity and atherosclerotic risk profile and there were no differences in the composite safety outcomes [cardiovascular death, cardiac arrest, device therapy, exercise-induced syncope, sustained VT, NSVT, or sustained atrial arrhythmias] between exercising individuals and usual care individuals,” Dr. Sharma said.

The full study will soon be ready to submit for publication, he added.

No commercial funding or relevant conflicts of interest were disclosed.

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

While rainbow-colored flags may wave proudly from hotel balconies and sports arenas, LGBTQ+ patients might still feel some discrimination in the medical space, according to a Center for American Progress survey.

“Despite health care being considered a basic human right by the World Health Organization, it’s common for LGBTQ+ folks to face difficulties not only when trying to access care but also within the walls of the doctor’s office or hospital,” says Samantha Estevez, MD, a reproductive endocrinology and infertility fellow in New York.

In Medscape’s Physicians’ Views on LGBTQ+ Rights Issues Report 2022: Strong Emotions, Contrary Opinions, physicians were asked whether they see disparities in the care LGBTQ+ patients receive in comparison with the care that non-LGBTQ+ patients receive. About 35% of physicians said LGBTQ+ patients receive a different level of care; 52% of respondents younger than 45 said so.

It’s an issue unlikely to be resolved without the medical community’s awareness. With insights from four LGBTQ+ clinicians, here are several steps physicians can take to close the disparity gap.
 

Update intake forms

Many patient medical forms are populated with checkboxes. These forms may make it easier for patients to share their medical information and for practices to collect data. But unfortunately, they don’t allow for patients to fill in contextual information.

“It’s extremely important for health care professionals to understand the people they are serving,” says Nicholas Grant, PhD, ABPP, president of GLMA: Health Professionals Advancing LGBTQ+ Equality. Dr. Grant is a board-certified clinical psychologist in Hawaii. “The more accurate we are with our information gathering and paperwork, the more accurate we will be at serving our LGBTQ+ communities.”

Dr. Grant recommends asking open-ended questions, such as the following:

• What is your gender identity?
• What was your assigned sex at birth?
• What pronouns do you prefer?
• What gender(s) are your sexual partners?

However, Frances Grimstad, MD, a Boston-based ob/gyn and GLMA board member, adds this advice: Before revising intake forms, consider their purpose.

“As an ob/gyn, information about a patient’s sexual orientation and their sexual activity is beneficial for my care,” says Dr. Grimstad. “But that information may not be relevant for a physical therapy clinic where most patients are coming in with knee injuries. So, you shouldn’t just place items on your intake forms by default. Instead, clinicians should consider what is relevant to the encounter you’re having and how you are going to use the information.”
 

Change signage

Take stock of posters and brochures in the office and signs outside restrooms. If they communicate traditional gender roles, then it may be time for a change.

“It’s important to ensure representation of all types of people and families in your office,” says Chase Anderson, MD, an assistant professor of child and adolescent psychiatry in San Francisco.

Hang posters with images of diverse families. Display brochures that address LGBTQ+ health concerns when warranted. And for restrooms, replace traditional binary images with gender-neutral ones. You can also add signage about each bathroom’s purpose, suggests Dr. Grimstad.

“Let’s not just de-gender bathrooms,” she says. “Let’s hang signs that tell if the bathroom has multiple stalls, urinals, or handicap access. Let signage focus on the functions of each bathroom, not gender.”
 

Ask for feedback

Feedback forms give LBGTQ+ patients a platform to share concerns. For example, consider an email with a linked document that all patients can fill out anonymously. Ask questions such as the following:

• Did you feel affirmed during your appointment? If so, how? If not, how can we improve?
• Did we use the proper pronouns?
• Did signage make you feel like you were in a safe space? What didn’t make you feel safe?

Set up a system with team members to process feedback and implement changes.

Also, if you have a large-scale practice, consider forming an LGBTQ+ community advisory board. “They can offer feedback about your practice’s clinical structure,” Dr. Grimstad tells Medscape.
 

Hire diverse employees

Building a diverse and inclusive workforce is critical to serving the LBGTQ+ community. Team members should reflect your patient population.

“Diversity isn’t a monolith,” says Dr. Grimstad. “It isn’t just racial diversity, or sexual or gender diversity. Even in a town which appears homogeneous in one area of diversity, such as a majority White town, it’s important to remember all the other facets of diversity that exist, such as gender, sexual orientation, cultural diversity.”

A diverse team may offer a surprising boost to your practice. According to a study published in the Journal of the National Medical Association, patient outcomes improve when a more diverse team provides care. In fact, diverse teams fare better in innovation, communication, risk assessment, and financial performance.

Dr. Anderson also recommends allowing team members “to be themselves.” For example, let employees wear their hair in whatever way they prefer or display their tattoos.

“This signals to patients that if staff members can be themselves here, patients can be themselves here, too,” says Dr. Anderson.
 

Provide training

Medical staff may sometimes feel uncomfortable serving LBGTQ+ patients because of their own biases, attitudes, or lack of knowledge about the community. Regular training can ease their discomfort.

“Make sure all health professionals are trained and educated on the needs of LGBTQ+ patients,” says Dr. Grant. “Understanding their health needs is the provider’s responsibility.”

For basic information, Dr. Anderson recommends visiting The Trevor Project, an organization that serves LGBTQ+ youth. “They’re really good at keeping up with changing verbiage and trends,” says Dr. Anderson.

To strengthen community connections, Dr. Grimstad recommends using trainers from your local area if possible. Do a Google search to find an LGBTQ+ center nearby or in the closest major city. Invite them to staff meetings or ask them to organize a workshop.

By implementing these strategies, you can start building a bridge between your practice and the LGBTQ+ community and provide better care for them as patients.

“Whether it’s knowing about PrEP ... or ensuring staff members are trained in caring for patients with any general or sexual identity, we as doctors and medical professionals must continue to move forward and serve our LGBTQ+ patients in big and small ways,” says Dr. Estevez.

For in-depth training, check the following organizations:

National LGBTQIA+ Health Education Center at the Fenway Institute provides educational programs and resources to health care organizations.

GLMA has a top 10 health issues webpage that doctors can use to educate themselves and staff members on the LGBTQ+ community’s most urgent health needs.

Alliance for Full Acceptance offers LGBTQ cultural competency training, including a 1-hour awareness class and a 3-hour inclusivity workshop for clinicians.

The Substance Abuse and Mental Health Services Administration has compiled a list of training curricula for behavioral health counselors and primary care providers.

UCSF’s Lesbian, Gay, Bisexual, and Transgender Resource Center has a list of training and educational materials for medical professionals.

Equality California Institute offers both in-person and virtual training covering basic terminology, data on LGBTQ+ health issues, and how to create an inclusive environment.

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

While rainbow-colored flags may wave proudly from hotel balconies and sports arenas, LGBTQ+ patients might still feel some discrimination in the medical space, according to a Center for American Progress survey.

“Despite health care being considered a basic human right by the World Health Organization, it’s common for LGBTQ+ folks to face difficulties not only when trying to access care but also within the walls of the doctor’s office or hospital,” says Samantha Estevez, MD, a reproductive endocrinology and infertility fellow in New York.

In Medscape’s Physicians’ Views on LGBTQ+ Rights Issues Report 2022: Strong Emotions, Contrary Opinions, physicians were asked whether they see disparities in the care LGBTQ+ patients receive in comparison with the care that non-LGBTQ+ patients receive. About 35% of physicians said LGBTQ+ patients receive a different level of care; 52% of respondents younger than 45 said so.

It’s an issue unlikely to be resolved without the medical community’s awareness. With insights from four LGBTQ+ clinicians, here are several steps physicians can take to close the disparity gap.
 

Update intake forms

Many patient medical forms are populated with checkboxes. These forms may make it easier for patients to share their medical information and for practices to collect data. But unfortunately, they don’t allow for patients to fill in contextual information.

“It’s extremely important for health care professionals to understand the people they are serving,” says Nicholas Grant, PhD, ABPP, president of GLMA: Health Professionals Advancing LGBTQ+ Equality. Dr. Grant is a board-certified clinical psychologist in Hawaii. “The more accurate we are with our information gathering and paperwork, the more accurate we will be at serving our LGBTQ+ communities.”

Dr. Grant recommends asking open-ended questions, such as the following:

• What is your gender identity?
• What was your assigned sex at birth?
• What pronouns do you prefer?
• What gender(s) are your sexual partners?

However, Frances Grimstad, MD, a Boston-based ob/gyn and GLMA board member, adds this advice: Before revising intake forms, consider their purpose.

“As an ob/gyn, information about a patient’s sexual orientation and their sexual activity is beneficial for my care,” says Dr. Grimstad. “But that information may not be relevant for a physical therapy clinic where most patients are coming in with knee injuries. So, you shouldn’t just place items on your intake forms by default. Instead, clinicians should consider what is relevant to the encounter you’re having and how you are going to use the information.”
 

Change signage

Take stock of posters and brochures in the office and signs outside restrooms. If they communicate traditional gender roles, then it may be time for a change.

“It’s important to ensure representation of all types of people and families in your office,” says Chase Anderson, MD, an assistant professor of child and adolescent psychiatry in San Francisco.

Hang posters with images of diverse families. Display brochures that address LGBTQ+ health concerns when warranted. And for restrooms, replace traditional binary images with gender-neutral ones. You can also add signage about each bathroom’s purpose, suggests Dr. Grimstad.

“Let’s not just de-gender bathrooms,” she says. “Let’s hang signs that tell if the bathroom has multiple stalls, urinals, or handicap access. Let signage focus on the functions of each bathroom, not gender.”
 

Ask for feedback

Feedback forms give LBGTQ+ patients a platform to share concerns. For example, consider an email with a linked document that all patients can fill out anonymously. Ask questions such as the following:

• Did you feel affirmed during your appointment? If so, how? If not, how can we improve?
• Did we use the proper pronouns?
• Did signage make you feel like you were in a safe space? What didn’t make you feel safe?

Set up a system with team members to process feedback and implement changes.

Also, if you have a large-scale practice, consider forming an LGBTQ+ community advisory board. “They can offer feedback about your practice’s clinical structure,” Dr. Grimstad tells Medscape.
 

Hire diverse employees

Building a diverse and inclusive workforce is critical to serving the LBGTQ+ community. Team members should reflect your patient population.

“Diversity isn’t a monolith,” says Dr. Grimstad. “It isn’t just racial diversity, or sexual or gender diversity. Even in a town which appears homogeneous in one area of diversity, such as a majority White town, it’s important to remember all the other facets of diversity that exist, such as gender, sexual orientation, cultural diversity.”

A diverse team may offer a surprising boost to your practice. According to a study published in the Journal of the National Medical Association, patient outcomes improve when a more diverse team provides care. In fact, diverse teams fare better in innovation, communication, risk assessment, and financial performance.

Dr. Anderson also recommends allowing team members “to be themselves.” For example, let employees wear their hair in whatever way they prefer or display their tattoos.

“This signals to patients that if staff members can be themselves here, patients can be themselves here, too,” says Dr. Anderson.
 

Provide training

Medical staff may sometimes feel uncomfortable serving LBGTQ+ patients because of their own biases, attitudes, or lack of knowledge about the community. Regular training can ease their discomfort.

“Make sure all health professionals are trained and educated on the needs of LGBTQ+ patients,” says Dr. Grant. “Understanding their health needs is the provider’s responsibility.”

For basic information, Dr. Anderson recommends visiting The Trevor Project, an organization that serves LGBTQ+ youth. “They’re really good at keeping up with changing verbiage and trends,” says Dr. Anderson.

To strengthen community connections, Dr. Grimstad recommends using trainers from your local area if possible. Do a Google search to find an LGBTQ+ center nearby or in the closest major city. Invite them to staff meetings or ask them to organize a workshop.

By implementing these strategies, you can start building a bridge between your practice and the LGBTQ+ community and provide better care for them as patients.

“Whether it’s knowing about PrEP ... or ensuring staff members are trained in caring for patients with any general or sexual identity, we as doctors and medical professionals must continue to move forward and serve our LGBTQ+ patients in big and small ways,” says Dr. Estevez.

For in-depth training, check the following organizations:

National LGBTQIA+ Health Education Center at the Fenway Institute provides educational programs and resources to health care organizations.

GLMA has a top 10 health issues webpage that doctors can use to educate themselves and staff members on the LGBTQ+ community’s most urgent health needs.

Alliance for Full Acceptance offers LGBTQ cultural competency training, including a 1-hour awareness class and a 3-hour inclusivity workshop for clinicians.

The Substance Abuse and Mental Health Services Administration has compiled a list of training curricula for behavioral health counselors and primary care providers.

UCSF’s Lesbian, Gay, Bisexual, and Transgender Resource Center has a list of training and educational materials for medical professionals.

Equality California Institute offers both in-person and virtual training covering basic terminology, data on LGBTQ+ health issues, and how to create an inclusive environment.

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

While rainbow-colored flags may wave proudly from hotel balconies and sports arenas, LGBTQ+ patients might still feel some discrimination in the medical space, according to a Center for American Progress survey.

“Despite health care being considered a basic human right by the World Health Organization, it’s common for LGBTQ+ folks to face difficulties not only when trying to access care but also within the walls of the doctor’s office or hospital,” says Samantha Estevez, MD, a reproductive endocrinology and infertility fellow in New York.

In Medscape’s Physicians’ Views on LGBTQ+ Rights Issues Report 2022: Strong Emotions, Contrary Opinions, physicians were asked whether they see disparities in the care LGBTQ+ patients receive in comparison with the care that non-LGBTQ+ patients receive. About 35% of physicians said LGBTQ+ patients receive a different level of care; 52% of respondents younger than 45 said so.

It’s an issue unlikely to be resolved without the medical community’s awareness. With insights from four LGBTQ+ clinicians, here are several steps physicians can take to close the disparity gap.
 

Update intake forms

Many patient medical forms are populated with checkboxes. These forms may make it easier for patients to share their medical information and for practices to collect data. But unfortunately, they don’t allow for patients to fill in contextual information.

“It’s extremely important for health care professionals to understand the people they are serving,” says Nicholas Grant, PhD, ABPP, president of GLMA: Health Professionals Advancing LGBTQ+ Equality. Dr. Grant is a board-certified clinical psychologist in Hawaii. “The more accurate we are with our information gathering and paperwork, the more accurate we will be at serving our LGBTQ+ communities.”

Dr. Grant recommends asking open-ended questions, such as the following:

• What is your gender identity?
• What was your assigned sex at birth?
• What pronouns do you prefer?
• What gender(s) are your sexual partners?

However, Frances Grimstad, MD, a Boston-based ob/gyn and GLMA board member, adds this advice: Before revising intake forms, consider their purpose.

“As an ob/gyn, information about a patient’s sexual orientation and their sexual activity is beneficial for my care,” says Dr. Grimstad. “But that information may not be relevant for a physical therapy clinic where most patients are coming in with knee injuries. So, you shouldn’t just place items on your intake forms by default. Instead, clinicians should consider what is relevant to the encounter you’re having and how you are going to use the information.”
 

Change signage

Take stock of posters and brochures in the office and signs outside restrooms. If they communicate traditional gender roles, then it may be time for a change.

“It’s important to ensure representation of all types of people and families in your office,” says Chase Anderson, MD, an assistant professor of child and adolescent psychiatry in San Francisco.

Hang posters with images of diverse families. Display brochures that address LGBTQ+ health concerns when warranted. And for restrooms, replace traditional binary images with gender-neutral ones. You can also add signage about each bathroom’s purpose, suggests Dr. Grimstad.

“Let’s not just de-gender bathrooms,” she says. “Let’s hang signs that tell if the bathroom has multiple stalls, urinals, or handicap access. Let signage focus on the functions of each bathroom, not gender.”
 

Ask for feedback

Feedback forms give LBGTQ+ patients a platform to share concerns. For example, consider an email with a linked document that all patients can fill out anonymously. Ask questions such as the following:

• Did you feel affirmed during your appointment? If so, how? If not, how can we improve?
• Did we use the proper pronouns?
• Did signage make you feel like you were in a safe space? What didn’t make you feel safe?

Set up a system with team members to process feedback and implement changes.

Also, if you have a large-scale practice, consider forming an LGBTQ+ community advisory board. “They can offer feedback about your practice’s clinical structure,” Dr. Grimstad tells Medscape.
 

Hire diverse employees

Building a diverse and inclusive workforce is critical to serving the LBGTQ+ community. Team members should reflect your patient population.

“Diversity isn’t a monolith,” says Dr. Grimstad. “It isn’t just racial diversity, or sexual or gender diversity. Even in a town which appears homogeneous in one area of diversity, such as a majority White town, it’s important to remember all the other facets of diversity that exist, such as gender, sexual orientation, cultural diversity.”

A diverse team may offer a surprising boost to your practice. According to a study published in the Journal of the National Medical Association, patient outcomes improve when a more diverse team provides care. In fact, diverse teams fare better in innovation, communication, risk assessment, and financial performance.

Dr. Anderson also recommends allowing team members “to be themselves.” For example, let employees wear their hair in whatever way they prefer or display their tattoos.

“This signals to patients that if staff members can be themselves here, patients can be themselves here, too,” says Dr. Anderson.
 

Provide training

Medical staff may sometimes feel uncomfortable serving LBGTQ+ patients because of their own biases, attitudes, or lack of knowledge about the community. Regular training can ease their discomfort.

“Make sure all health professionals are trained and educated on the needs of LGBTQ+ patients,” says Dr. Grant. “Understanding their health needs is the provider’s responsibility.”

For basic information, Dr. Anderson recommends visiting The Trevor Project, an organization that serves LGBTQ+ youth. “They’re really good at keeping up with changing verbiage and trends,” says Dr. Anderson.

To strengthen community connections, Dr. Grimstad recommends using trainers from your local area if possible. Do a Google search to find an LGBTQ+ center nearby or in the closest major city. Invite them to staff meetings or ask them to organize a workshop.

By implementing these strategies, you can start building a bridge between your practice and the LGBTQ+ community and provide better care for them as patients.

“Whether it’s knowing about PrEP ... or ensuring staff members are trained in caring for patients with any general or sexual identity, we as doctors and medical professionals must continue to move forward and serve our LGBTQ+ patients in big and small ways,” says Dr. Estevez.

For in-depth training, check the following organizations:

National LGBTQIA+ Health Education Center at the Fenway Institute provides educational programs and resources to health care organizations.

GLMA has a top 10 health issues webpage that doctors can use to educate themselves and staff members on the LGBTQ+ community’s most urgent health needs.

Alliance for Full Acceptance offers LGBTQ cultural competency training, including a 1-hour awareness class and a 3-hour inclusivity workshop for clinicians.

The Substance Abuse and Mental Health Services Administration has compiled a list of training curricula for behavioral health counselors and primary care providers.

UCSF’s Lesbian, Gay, Bisexual, and Transgender Resource Center has a list of training and educational materials for medical professionals.

Equality California Institute offers both in-person and virtual training covering basic terminology, data on LGBTQ+ health issues, and how to create an inclusive environment.

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

ANAHEIM, CALIF. – Black and Hispanic pediatric faculty earn less than their White counterparts regardless of rank and degree, according to a study presented at the American Academy of Pediatrics National Conference.

“Our results demonstrated broad disparities in compensation by both gender and race/ethnicity,” Kimberly Montez, MD, MPH, of the department of pediatrics at Wake Forest University, Winston-Salem, N.C., told attendees.

Arghavan Salles, MD, PhD, of Stanford (Calif.) University and a senior research scholar at the Clayman Institute for Gender Research, also in Stanford, was not involved in this study but conducts similar research and was unsurprised by these findings.

“It may surprise some people that these gender-based disparities persist in pediatrics, given it is a female-dominated specialty,” Dr. Salles said in an interview. “However, we see the same pattern in other female-dominated medical fields, such as obstetrics and gynecology and nursing.”

Dr. Montez, also the associate director of Wake Forest’s Maya Angelou Center for Health Equity and the associate editor for Diversity, Equity, Inclusion and Justice at the journal Pediatrics, told attendees that it’s important for academic medical centers to “identify, acknowledge, and address inequities in compensation models, including conducting transparent salary audits, standardizing new hire compensation benchmarks, and automatic review of salary outliers.”

Among the barriers to advancement that exist in academic medicine for individuals underrepresented in medicine are “racism, bias, discrimination, lack of mentorship, and the minority tax – extra responsibilities placed on individuals in the name of diversity,” Dr. Montez said. She drew attention to an article she coauthored in Pediatrics in August that highlighted how historically underrepresented individuals’ representation declined as rank increased and how the diversity of faculty pediatricians does not reflect that of the U.S. population.

Dr. Salles elaborated on the “minority tax” Dr. Montez referenced.

Faculty who are underrepresented in medicine “unfairly bear the majority of the responsibility to mentor [underrepresented] trainees and are more likely to be asked to serve in diversity, equity, and inclusion roles,” Dr. Salles said. “This work is too often uncompensated and undervalued, thereby affecting compensation.” This work also plays a role in gender salary disparities since women, especially women of color, are more likely to take on these roles, Dr. Salles added.

In this study, Dr. Montez and her colleagues aimed to investigate the differences in pediatric faculty salaries by race, ethnicity, and rank and then assess the association of median salary with race/ethnicity after adjustment for degree, rank, and gender. They conducted a cross-sectional study relying on 2020-2021 pediatric faculty median compensation data from the Association of American Medical Colleges annual Medical School Faculty Salary Survey report. The report had a response rate greater than 98% from the 152 medical schools queried.

For both the AAMC report and this study, individuals underrepresented in medicine included those who are African American/Black, Hispanic, American Indian/Alaska Native, or Native Hawaiian/Pacific Islander.

The survey included data on 26,548 pediatric faculty, 58% of whom were women, with a median salary of $216,289. Two-thirds of these faculty (67.2%) were White, 4.5% were Hispanic, and 4.4% were Black. Half (50%) were assistant professors, 25% were associate professors, and 17% were professors.

”Women were overly represented among instructors and assistant professors, while men were overly represented [among] associate professors, professors, chiefs, and chairs,” the authors reported. “Men consistently had higher median salaries among all ranks and races/ethnicities.”

For positions of associate professor, professor, chief, and chair, representation of those underrepresented in medicine decreased compared with their overall percentage, but the trend was the opposite for White faculty, who were overrepresented in higher positions relative to their overall percentage. Those with the lowest median salary across all ranks and races/ethnicities were Hispanic women.

Median salaries for those underrepresented in medicine were lower than salaries of White faculty even after adjustment for degree. Black, Hispanic, and American Indian or Alaska Native faculty also had lower median salaries than White faculty after adjusting for rank, but Asian faculty and those who self-identified as “other” race/ethnicity had slightly higher median salaries than White faculty.

Though the findings were not surprising overall, Dr. Montez did note a couple unexpected findings: Hispanic women earn the least across all ranks and Black men earn the most at the associate and professor levels – though Black men also represent a very tiny percentage of individuals at those ranks in the first place.

Dr. Salles noted that the gender wage gap appears widest for Hispanic physicians, compared with White or Black physicians. “It’s important to keep in mind, though, that due to structural racism, implicit bias, and many other factors, there are very few Black and Hispanic full professors of medicine,” Dr. Salles said.  

“Gender bias, sexism, and misogyny” are among the many factors that contribute to the gender pay gap,” Dr. Salles said, and ”the work of women is not valued in the same way as the work of men.”

She pointed to past research showing that CVs with male names at the top are judged as better than those with female names at the top.

”Similarly, it will be judged as being better if the name is Emily or Greg rather than Lakisha or Jamal,” Dr. Salles said. “These findings suggest we evaluate people’s work through the lens of who we think they are and we automatically judge women and other marginalized people to be less worthy.”

Dr. Montez agreed that discrimination is the most likely reason for the salary disparities between men and women and also noted additional factors.

“Women are more likely to shoulder the household and childcare responsibilities as compared to men and they may accept a lower salary for other benefits, such as flexible work hours [and] onsite childcare,” Dr. Montez said. In addition, she said, since most chairs in academic pediatrics are men, new women faculty may not feel able to negotiate higher salaries, or may feel different pressures than men.

Dr. Salles emphasized the importance of not blaming women for not negotiating enough since “women pay a social penalty when they do negotiate.” This problem is likely compounded for women of color, she added. “Offering equitable packages to begin with, rather than requiring applicants to negotiate, would be more equitable.”

Because the AAMC report data was disaggregated, it’s not possible to identify trends by institution, Dr. Montez said, but the August article specifically recommends “that future data be institution specific, and provide race, ethnicity, sex, and rank information, including hiring and promotion details,” including salary information.

In fact, a publicly available, institution-specific equity dashboard would be a “minimum starting point” for tracking and addressing disparities as well as the effect of any interventions, Dr. Montez said. She noted other potential policies that could ameliorate disparities.

“Given that caregiving responsibilities for women often lead to fewer hours worked, work interruptions, and less opportunity for advancement, restructuring jobs with more flexible work schedules without pay reduction and not limiting advancement based on part-time status could be considered,” Dr. Montez said. ”For promotion, given that individuals [underrepresented in medicine] often shoulder the minority tax, institutions should develop promotion criteria to account for this academic credit. Institutions could also implement an annual salary-monitoring system with corrections, should it reveal disparities.”

Dr. Salles consults for Intuitive Surgical and the Intuitive Foundation, but neither of these are related to diversity, equity, and inclusion. Dr. Montez had no disclosures. The study involved no external funding.

ANAHEIM, CALIF. – Black and Hispanic pediatric faculty earn less than their White counterparts regardless of rank and degree, according to a study presented at the American Academy of Pediatrics National Conference.

“Our results demonstrated broad disparities in compensation by both gender and race/ethnicity,” Kimberly Montez, MD, MPH, of the department of pediatrics at Wake Forest University, Winston-Salem, N.C., told attendees.

Arghavan Salles, MD, PhD, of Stanford (Calif.) University and a senior research scholar at the Clayman Institute for Gender Research, also in Stanford, was not involved in this study but conducts similar research and was unsurprised by these findings.

“It may surprise some people that these gender-based disparities persist in pediatrics, given it is a female-dominated specialty,” Dr. Salles said in an interview. “However, we see the same pattern in other female-dominated medical fields, such as obstetrics and gynecology and nursing.”

Dr. Montez, also the associate director of Wake Forest’s Maya Angelou Center for Health Equity and the associate editor for Diversity, Equity, Inclusion and Justice at the journal Pediatrics, told attendees that it’s important for academic medical centers to “identify, acknowledge, and address inequities in compensation models, including conducting transparent salary audits, standardizing new hire compensation benchmarks, and automatic review of salary outliers.”

Among the barriers to advancement that exist in academic medicine for individuals underrepresented in medicine are “racism, bias, discrimination, lack of mentorship, and the minority tax – extra responsibilities placed on individuals in the name of diversity,” Dr. Montez said. She drew attention to an article she coauthored in Pediatrics in August that highlighted how historically underrepresented individuals’ representation declined as rank increased and how the diversity of faculty pediatricians does not reflect that of the U.S. population.

Dr. Salles elaborated on the “minority tax” Dr. Montez referenced.

Faculty who are underrepresented in medicine “unfairly bear the majority of the responsibility to mentor [underrepresented] trainees and are more likely to be asked to serve in diversity, equity, and inclusion roles,” Dr. Salles said. “This work is too often uncompensated and undervalued, thereby affecting compensation.” This work also plays a role in gender salary disparities since women, especially women of color, are more likely to take on these roles, Dr. Salles added.

In this study, Dr. Montez and her colleagues aimed to investigate the differences in pediatric faculty salaries by race, ethnicity, and rank and then assess the association of median salary with race/ethnicity after adjustment for degree, rank, and gender. They conducted a cross-sectional study relying on 2020-2021 pediatric faculty median compensation data from the Association of American Medical Colleges annual Medical School Faculty Salary Survey report. The report had a response rate greater than 98% from the 152 medical schools queried.

For both the AAMC report and this study, individuals underrepresented in medicine included those who are African American/Black, Hispanic, American Indian/Alaska Native, or Native Hawaiian/Pacific Islander.

The survey included data on 26,548 pediatric faculty, 58% of whom were women, with a median salary of $216,289. Two-thirds of these faculty (67.2%) were White, 4.5% were Hispanic, and 4.4% were Black. Half (50%) were assistant professors, 25% were associate professors, and 17% were professors.

”Women were overly represented among instructors and assistant professors, while men were overly represented [among] associate professors, professors, chiefs, and chairs,” the authors reported. “Men consistently had higher median salaries among all ranks and races/ethnicities.”

For positions of associate professor, professor, chief, and chair, representation of those underrepresented in medicine decreased compared with their overall percentage, but the trend was the opposite for White faculty, who were overrepresented in higher positions relative to their overall percentage. Those with the lowest median salary across all ranks and races/ethnicities were Hispanic women.

Median salaries for those underrepresented in medicine were lower than salaries of White faculty even after adjustment for degree. Black, Hispanic, and American Indian or Alaska Native faculty also had lower median salaries than White faculty after adjusting for rank, but Asian faculty and those who self-identified as “other” race/ethnicity had slightly higher median salaries than White faculty.

Though the findings were not surprising overall, Dr. Montez did note a couple unexpected findings: Hispanic women earn the least across all ranks and Black men earn the most at the associate and professor levels – though Black men also represent a very tiny percentage of individuals at those ranks in the first place.

Dr. Salles noted that the gender wage gap appears widest for Hispanic physicians, compared with White or Black physicians. “It’s important to keep in mind, though, that due to structural racism, implicit bias, and many other factors, there are very few Black and Hispanic full professors of medicine,” Dr. Salles said.  

“Gender bias, sexism, and misogyny” are among the many factors that contribute to the gender pay gap,” Dr. Salles said, and ”the work of women is not valued in the same way as the work of men.”

She pointed to past research showing that CVs with male names at the top are judged as better than those with female names at the top.

”Similarly, it will be judged as being better if the name is Emily or Greg rather than Lakisha or Jamal,” Dr. Salles said. “These findings suggest we evaluate people’s work through the lens of who we think they are and we automatically judge women and other marginalized people to be less worthy.”

Dr. Montez agreed that discrimination is the most likely reason for the salary disparities between men and women and also noted additional factors.

“Women are more likely to shoulder the household and childcare responsibilities as compared to men and they may accept a lower salary for other benefits, such as flexible work hours [and] onsite childcare,” Dr. Montez said. In addition, she said, since most chairs in academic pediatrics are men, new women faculty may not feel able to negotiate higher salaries, or may feel different pressures than men.

Dr. Salles emphasized the importance of not blaming women for not negotiating enough since “women pay a social penalty when they do negotiate.” This problem is likely compounded for women of color, she added. “Offering equitable packages to begin with, rather than requiring applicants to negotiate, would be more equitable.”

Because the AAMC report data was disaggregated, it’s not possible to identify trends by institution, Dr. Montez said, but the August article specifically recommends “that future data be institution specific, and provide race, ethnicity, sex, and rank information, including hiring and promotion details,” including salary information.

In fact, a publicly available, institution-specific equity dashboard would be a “minimum starting point” for tracking and addressing disparities as well as the effect of any interventions, Dr. Montez said. She noted other potential policies that could ameliorate disparities.

“Given that caregiving responsibilities for women often lead to fewer hours worked, work interruptions, and less opportunity for advancement, restructuring jobs with more flexible work schedules without pay reduction and not limiting advancement based on part-time status could be considered,” Dr. Montez said. ”For promotion, given that individuals [underrepresented in medicine] often shoulder the minority tax, institutions should develop promotion criteria to account for this academic credit. Institutions could also implement an annual salary-monitoring system with corrections, should it reveal disparities.”

Dr. Salles consults for Intuitive Surgical and the Intuitive Foundation, but neither of these are related to diversity, equity, and inclusion. Dr. Montez had no disclosures. The study involved no external funding.

ANAHEIM, CALIF. – Black and Hispanic pediatric faculty earn less than their White counterparts regardless of rank and degree, according to a study presented at the American Academy of Pediatrics National Conference.

“Our results demonstrated broad disparities in compensation by both gender and race/ethnicity,” Kimberly Montez, MD, MPH, of the department of pediatrics at Wake Forest University, Winston-Salem, N.C., told attendees.

Arghavan Salles, MD, PhD, of Stanford (Calif.) University and a senior research scholar at the Clayman Institute for Gender Research, also in Stanford, was not involved in this study but conducts similar research and was unsurprised by these findings.

“It may surprise some people that these gender-based disparities persist in pediatrics, given it is a female-dominated specialty,” Dr. Salles said in an interview. “However, we see the same pattern in other female-dominated medical fields, such as obstetrics and gynecology and nursing.”

Dr. Montez, also the associate director of Wake Forest’s Maya Angelou Center for Health Equity and the associate editor for Diversity, Equity, Inclusion and Justice at the journal Pediatrics, told attendees that it’s important for academic medical centers to “identify, acknowledge, and address inequities in compensation models, including conducting transparent salary audits, standardizing new hire compensation benchmarks, and automatic review of salary outliers.”

Among the barriers to advancement that exist in academic medicine for individuals underrepresented in medicine are “racism, bias, discrimination, lack of mentorship, and the minority tax – extra responsibilities placed on individuals in the name of diversity,” Dr. Montez said. She drew attention to an article she coauthored in Pediatrics in August that highlighted how historically underrepresented individuals’ representation declined as rank increased and how the diversity of faculty pediatricians does not reflect that of the U.S. population.

Dr. Salles elaborated on the “minority tax” Dr. Montez referenced.

Faculty who are underrepresented in medicine “unfairly bear the majority of the responsibility to mentor [underrepresented] trainees and are more likely to be asked to serve in diversity, equity, and inclusion roles,” Dr. Salles said. “This work is too often uncompensated and undervalued, thereby affecting compensation.” This work also plays a role in gender salary disparities since women, especially women of color, are more likely to take on these roles, Dr. Salles added.

In this study, Dr. Montez and her colleagues aimed to investigate the differences in pediatric faculty salaries by race, ethnicity, and rank and then assess the association of median salary with race/ethnicity after adjustment for degree, rank, and gender. They conducted a cross-sectional study relying on 2020-2021 pediatric faculty median compensation data from the Association of American Medical Colleges annual Medical School Faculty Salary Survey report. The report had a response rate greater than 98% from the 152 medical schools queried.

For both the AAMC report and this study, individuals underrepresented in medicine included those who are African American/Black, Hispanic, American Indian/Alaska Native, or Native Hawaiian/Pacific Islander.

The survey included data on 26,548 pediatric faculty, 58% of whom were women, with a median salary of $216,289. Two-thirds of these faculty (67.2%) were White, 4.5% were Hispanic, and 4.4% were Black. Half (50%) were assistant professors, 25% were associate professors, and 17% were professors.

”Women were overly represented among instructors and assistant professors, while men were overly represented [among] associate professors, professors, chiefs, and chairs,” the authors reported. “Men consistently had higher median salaries among all ranks and races/ethnicities.”

For positions of associate professor, professor, chief, and chair, representation of those underrepresented in medicine decreased compared with their overall percentage, but the trend was the opposite for White faculty, who were overrepresented in higher positions relative to their overall percentage. Those with the lowest median salary across all ranks and races/ethnicities were Hispanic women.

Median salaries for those underrepresented in medicine were lower than salaries of White faculty even after adjustment for degree. Black, Hispanic, and American Indian or Alaska Native faculty also had lower median salaries than White faculty after adjusting for rank, but Asian faculty and those who self-identified as “other” race/ethnicity had slightly higher median salaries than White faculty.

Though the findings were not surprising overall, Dr. Montez did note a couple unexpected findings: Hispanic women earn the least across all ranks and Black men earn the most at the associate and professor levels – though Black men also represent a very tiny percentage of individuals at those ranks in the first place.

Dr. Salles noted that the gender wage gap appears widest for Hispanic physicians, compared with White or Black physicians. “It’s important to keep in mind, though, that due to structural racism, implicit bias, and many other factors, there are very few Black and Hispanic full professors of medicine,” Dr. Salles said.  

“Gender bias, sexism, and misogyny” are among the many factors that contribute to the gender pay gap,” Dr. Salles said, and ”the work of women is not valued in the same way as the work of men.”

She pointed to past research showing that CVs with male names at the top are judged as better than those with female names at the top.

”Similarly, it will be judged as being better if the name is Emily or Greg rather than Lakisha or Jamal,” Dr. Salles said. “These findings suggest we evaluate people’s work through the lens of who we think they are and we automatically judge women and other marginalized people to be less worthy.”

Dr. Montez agreed that discrimination is the most likely reason for the salary disparities between men and women and also noted additional factors.

“Women are more likely to shoulder the household and childcare responsibilities as compared to men and they may accept a lower salary for other benefits, such as flexible work hours [and] onsite childcare,” Dr. Montez said. In addition, she said, since most chairs in academic pediatrics are men, new women faculty may not feel able to negotiate higher salaries, or may feel different pressures than men.

Dr. Salles emphasized the importance of not blaming women for not negotiating enough since “women pay a social penalty when they do negotiate.” This problem is likely compounded for women of color, she added. “Offering equitable packages to begin with, rather than requiring applicants to negotiate, would be more equitable.”

Because the AAMC report data was disaggregated, it’s not possible to identify trends by institution, Dr. Montez said, but the August article specifically recommends “that future data be institution specific, and provide race, ethnicity, sex, and rank information, including hiring and promotion details,” including salary information.

In fact, a publicly available, institution-specific equity dashboard would be a “minimum starting point” for tracking and addressing disparities as well as the effect of any interventions, Dr. Montez said. She noted other potential policies that could ameliorate disparities.

“Given that caregiving responsibilities for women often lead to fewer hours worked, work interruptions, and less opportunity for advancement, restructuring jobs with more flexible work schedules without pay reduction and not limiting advancement based on part-time status could be considered,” Dr. Montez said. ”For promotion, given that individuals [underrepresented in medicine] often shoulder the minority tax, institutions should develop promotion criteria to account for this academic credit. Institutions could also implement an annual salary-monitoring system with corrections, should it reveal disparities.”

Dr. Salles consults for Intuitive Surgical and the Intuitive Foundation, but neither of these are related to diversity, equity, and inclusion. Dr. Montez had no disclosures. The study involved no external funding.

This transcript has been edited for clarity.

Hello. This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about the recent research (particularly randomized clinical trials) of vitamin D supplementation and the implications for clinical practice. As a director of the Vitamin D and Omega-3 trial (VITAL), the largest randomized clinical trial in the world, I’m often asked, “How much vitamin D do we need, and should I take a vitamin D supplement?” I want to review the findings from recent randomized clinical trials and the implications for practice.

For a long time, vitamin D has been perceived as a magic bullet, a panacea, and a cure-all for many chronic health conditions such as cancer, cardiovascular disease, diabetes, bone fractures, cognitive decline, and depression. Many of the findings, though, have been from observational studies where a higher blood level of 25-hydroxy vitamin D has been linked to a lower risk for these health conditions.

We know in epidemiology that correlation doesn’t prove causation. Other factors could be involved; for example, people who have higher blood levels of vitamin D may have healthier diets, or they may be spending more time outdoors, being physically active and exposed to the sun. Some of these other factors could be lowering their risk.

When the randomized trials began to emerge, in many of these large-scale trials, the findings were generally neutral or null for cardiovascular disease, total cancer, diabetes, cognitive decline, depression, and many other health outcomes, including fracture. So, the question was asked, does this mean that vitamin D is not important to health?

To the contrary, these findings suggest that vitamin D is so essential to health that we need only small to moderate amounts of vitamin D. Vitamin D is very tightly regulated in the body – the metabolism and function of vitamin D. Even small to moderate amounts will meet the requirements for vitamin D and bone health and many other outcomes.

This is what the National Academy of Medicine, U.S. Preventive Services Task Force, and many other professional organizations have advised, that widespread screening for vitamin D deficiency and blanket universal supplementation with vitamin D would not be indicated.

The randomized trials of vitamin D, including the VITAL study, have generally not shown reductions in the major health outcomes. We found two exceptions in VITAL. We saw promising signals, including a 22% reduction in autoimmune conditions (rheumatoid arthritis and psoriasis) and a 17% reduction in advanced (metastatic or fatal) cancers. In meta-analyses of other large-scale randomized trials, the findings were a signal for a reduction in advanced cancers, even with very small doses of vitamin D (400-800 IUs daily). We tested 2,000 IUs daily in VITAL.

Overall, it’s recommended that small to moderate amounts of vitamin D are adequate, and among the healthy population, most people do not need screening or supplements.

The reduction in autoimmune diseases suggests that vitamin D may play a role in tamping down inflammation. The question has been raised about whether vitamin D is beneficial in reducing the severity of COVID illness, the need for hospitalization, and long COVID. We are looking at this question in a separate trial called VIVID (Vitamin D for COVID Trial) which tests a higher dose (> 3,000 IUs daily) of vitamin D. Those results will be available at the end of this year or early next year.

In other randomized trials of COVID and vitamin D, the results have been mixed and inconsistent, with no clear answer. During the COVID pandemic, I have generally advised that it’s reasonable to take 1,000-2,000 IUs of vitamin D daily as a form of insurance. This dose is known to be very safe. Over 5.3 years in the VITAL trial we saw that a dose of 2,000 IUs was very safe.

But it’s not essential to take a supplement. And overall, aside from some high-risk groups, most people do not need a supplement. The high-risk groups include patients in nursing homes who may have restricted diets and limited time out of doors. For people with malabsorption conditions such as Crohn’s disease, celiac disease, post–gastric bypass surgery, and those with osteoporosis who are on medications for osteoporosis, it’s still quite reasonable to prescribe calcium and vitamin D.

Recommendations for vitamin D in the generally healthy population really should focus on a healthy diet. The United States has a fortified food supply. Vitamin D is added to many foods, dairy products, and cereals, as well as beverages. Natural sources of vitamin D include fatty fish and wild mushrooms.

We should be looking at food labels (which now include vitamin D content) and try to get adequate vitamin D from our diet, and also do our best to spend time outdoors, being physically active, because it is of great benefit to our health. The general principle is that a dietary supplement will never be a substitute for a healthy diet or healthy lifestyle. And those other behaviors really should be the focus at this time.

Dr. Manson is professor of medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, and chief of the division of preventive medicine at Brigham and Women’s Hospital, both in Boston. She has received infrastructure support from Mars Symbioscience for the COSMOS trial.

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

This transcript has been edited for clarity.

Hello. This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about the recent research (particularly randomized clinical trials) of vitamin D supplementation and the implications for clinical practice. As a director of the Vitamin D and Omega-3 trial (VITAL), the largest randomized clinical trial in the world, I’m often asked, “How much vitamin D do we need, and should I take a vitamin D supplement?” I want to review the findings from recent randomized clinical trials and the implications for practice.

For a long time, vitamin D has been perceived as a magic bullet, a panacea, and a cure-all for many chronic health conditions such as cancer, cardiovascular disease, diabetes, bone fractures, cognitive decline, and depression. Many of the findings, though, have been from observational studies where a higher blood level of 25-hydroxy vitamin D has been linked to a lower risk for these health conditions.

We know in epidemiology that correlation doesn’t prove causation. Other factors could be involved; for example, people who have higher blood levels of vitamin D may have healthier diets, or they may be spending more time outdoors, being physically active and exposed to the sun. Some of these other factors could be lowering their risk.

When the randomized trials began to emerge, in many of these large-scale trials, the findings were generally neutral or null for cardiovascular disease, total cancer, diabetes, cognitive decline, depression, and many other health outcomes, including fracture. So, the question was asked, does this mean that vitamin D is not important to health?

To the contrary, these findings suggest that vitamin D is so essential to health that we need only small to moderate amounts of vitamin D. Vitamin D is very tightly regulated in the body – the metabolism and function of vitamin D. Even small to moderate amounts will meet the requirements for vitamin D and bone health and many other outcomes.

This is what the National Academy of Medicine, U.S. Preventive Services Task Force, and many other professional organizations have advised, that widespread screening for vitamin D deficiency and blanket universal supplementation with vitamin D would not be indicated.

The randomized trials of vitamin D, including the VITAL study, have generally not shown reductions in the major health outcomes. We found two exceptions in VITAL. We saw promising signals, including a 22% reduction in autoimmune conditions (rheumatoid arthritis and psoriasis) and a 17% reduction in advanced (metastatic or fatal) cancers. In meta-analyses of other large-scale randomized trials, the findings were a signal for a reduction in advanced cancers, even with very small doses of vitamin D (400-800 IUs daily). We tested 2,000 IUs daily in VITAL.

Overall, it’s recommended that small to moderate amounts of vitamin D are adequate, and among the healthy population, most people do not need screening or supplements.

The reduction in autoimmune diseases suggests that vitamin D may play a role in tamping down inflammation. The question has been raised about whether vitamin D is beneficial in reducing the severity of COVID illness, the need for hospitalization, and long COVID. We are looking at this question in a separate trial called VIVID (Vitamin D for COVID Trial) which tests a higher dose (> 3,000 IUs daily) of vitamin D. Those results will be available at the end of this year or early next year.

In other randomized trials of COVID and vitamin D, the results have been mixed and inconsistent, with no clear answer. During the COVID pandemic, I have generally advised that it’s reasonable to take 1,000-2,000 IUs of vitamin D daily as a form of insurance. This dose is known to be very safe. Over 5.3 years in the VITAL trial we saw that a dose of 2,000 IUs was very safe.

But it’s not essential to take a supplement. And overall, aside from some high-risk groups, most people do not need a supplement. The high-risk groups include patients in nursing homes who may have restricted diets and limited time out of doors. For people with malabsorption conditions such as Crohn’s disease, celiac disease, post–gastric bypass surgery, and those with osteoporosis who are on medications for osteoporosis, it’s still quite reasonable to prescribe calcium and vitamin D.

Recommendations for vitamin D in the generally healthy population really should focus on a healthy diet. The United States has a fortified food supply. Vitamin D is added to many foods, dairy products, and cereals, as well as beverages. Natural sources of vitamin D include fatty fish and wild mushrooms.

We should be looking at food labels (which now include vitamin D content) and try to get adequate vitamin D from our diet, and also do our best to spend time outdoors, being physically active, because it is of great benefit to our health. The general principle is that a dietary supplement will never be a substitute for a healthy diet or healthy lifestyle. And those other behaviors really should be the focus at this time.

Dr. Manson is professor of medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, and chief of the division of preventive medicine at Brigham and Women’s Hospital, both in Boston. She has received infrastructure support from Mars Symbioscience for the COSMOS trial.

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

This transcript has been edited for clarity.

Hello. This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about the recent research (particularly randomized clinical trials) of vitamin D supplementation and the implications for clinical practice. As a director of the Vitamin D and Omega-3 trial (VITAL), the largest randomized clinical trial in the world, I’m often asked, “How much vitamin D do we need, and should I take a vitamin D supplement?” I want to review the findings from recent randomized clinical trials and the implications for practice.

For a long time, vitamin D has been perceived as a magic bullet, a panacea, and a cure-all for many chronic health conditions such as cancer, cardiovascular disease, diabetes, bone fractures, cognitive decline, and depression. Many of the findings, though, have been from observational studies where a higher blood level of 25-hydroxy vitamin D has been linked to a lower risk for these health conditions.

We know in epidemiology that correlation doesn’t prove causation. Other factors could be involved; for example, people who have higher blood levels of vitamin D may have healthier diets, or they may be spending more time outdoors, being physically active and exposed to the sun. Some of these other factors could be lowering their risk.

When the randomized trials began to emerge, in many of these large-scale trials, the findings were generally neutral or null for cardiovascular disease, total cancer, diabetes, cognitive decline, depression, and many other health outcomes, including fracture. So, the question was asked, does this mean that vitamin D is not important to health?

To the contrary, these findings suggest that vitamin D is so essential to health that we need only small to moderate amounts of vitamin D. Vitamin D is very tightly regulated in the body – the metabolism and function of vitamin D. Even small to moderate amounts will meet the requirements for vitamin D and bone health and many other outcomes.

This is what the National Academy of Medicine, U.S. Preventive Services Task Force, and many other professional organizations have advised, that widespread screening for vitamin D deficiency and blanket universal supplementation with vitamin D would not be indicated.

The randomized trials of vitamin D, including the VITAL study, have generally not shown reductions in the major health outcomes. We found two exceptions in VITAL. We saw promising signals, including a 22% reduction in autoimmune conditions (rheumatoid arthritis and psoriasis) and a 17% reduction in advanced (metastatic or fatal) cancers. In meta-analyses of other large-scale randomized trials, the findings were a signal for a reduction in advanced cancers, even with very small doses of vitamin D (400-800 IUs daily). We tested 2,000 IUs daily in VITAL.

Overall, it’s recommended that small to moderate amounts of vitamin D are adequate, and among the healthy population, most people do not need screening or supplements.

The reduction in autoimmune diseases suggests that vitamin D may play a role in tamping down inflammation. The question has been raised about whether vitamin D is beneficial in reducing the severity of COVID illness, the need for hospitalization, and long COVID. We are looking at this question in a separate trial called VIVID (Vitamin D for COVID Trial) which tests a higher dose (> 3,000 IUs daily) of vitamin D. Those results will be available at the end of this year or early next year.

In other randomized trials of COVID and vitamin D, the results have been mixed and inconsistent, with no clear answer. During the COVID pandemic, I have generally advised that it’s reasonable to take 1,000-2,000 IUs of vitamin D daily as a form of insurance. This dose is known to be very safe. Over 5.3 years in the VITAL trial we saw that a dose of 2,000 IUs was very safe.

But it’s not essential to take a supplement. And overall, aside from some high-risk groups, most people do not need a supplement. The high-risk groups include patients in nursing homes who may have restricted diets and limited time out of doors. For people with malabsorption conditions such as Crohn’s disease, celiac disease, post–gastric bypass surgery, and those with osteoporosis who are on medications for osteoporosis, it’s still quite reasonable to prescribe calcium and vitamin D.

Recommendations for vitamin D in the generally healthy population really should focus on a healthy diet. The United States has a fortified food supply. Vitamin D is added to many foods, dairy products, and cereals, as well as beverages. Natural sources of vitamin D include fatty fish and wild mushrooms.

We should be looking at food labels (which now include vitamin D content) and try to get adequate vitamin D from our diet, and also do our best to spend time outdoors, being physically active, because it is of great benefit to our health. The general principle is that a dietary supplement will never be a substitute for a healthy diet or healthy lifestyle. And those other behaviors really should be the focus at this time.

Dr. Manson is professor of medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School, and chief of the division of preventive medicine at Brigham and Women’s Hospital, both in Boston. She has received infrastructure support from Mars Symbioscience for the COSMOS trial.

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

The U.S. Food and Drug Administration has confirmed a nationwide shortage of the immediate release formulation of amphetamine mixed salts (Adderall, Adderall IR), which are approved for treating attention deficit hyperactivity disorder and narcolepsy.

The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.

The agency said it is in “frequent” contact with all manufacturers of Adderall – and reported that one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.

Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through those producers, the FDA noted.

“Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts, available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the agency said.

Patients should work with their health care provider to determine their best treatment option, it added.

The organization is continuing to monitor the supply of Adderall and to help manufacturers resolve the shortage.

Its Drug Shortage webpage has additional information about the situation and is updated regularly.

“We continue to use all the tools we have available to help keep supply available for patients and will provide public updates regarding the Adderall shortage,” the FDA said.

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

The U.S. Food and Drug Administration has confirmed a nationwide shortage of the immediate release formulation of amphetamine mixed salts (Adderall, Adderall IR), which are approved for treating attention deficit hyperactivity disorder and narcolepsy.

The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.

The agency said it is in “frequent” contact with all manufacturers of Adderall – and reported that one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.

Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through those producers, the FDA noted.

“Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts, available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the agency said.

Patients should work with their health care provider to determine their best treatment option, it added.

The organization is continuing to monitor the supply of Adderall and to help manufacturers resolve the shortage.

Its Drug Shortage webpage has additional information about the situation and is updated regularly.

“We continue to use all the tools we have available to help keep supply available for patients and will provide public updates regarding the Adderall shortage,” the FDA said.

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

The U.S. Food and Drug Administration has confirmed a nationwide shortage of the immediate release formulation of amphetamine mixed salts (Adderall, Adderall IR), which are approved for treating attention deficit hyperactivity disorder and narcolepsy.

The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.

The agency said it is in “frequent” contact with all manufacturers of Adderall – and reported that one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.

Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through those producers, the FDA noted.

“Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts, available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the agency said.

Patients should work with their health care provider to determine their best treatment option, it added.

The organization is continuing to monitor the supply of Adderall and to help manufacturers resolve the shortage.

Its Drug Shortage webpage has additional information about the situation and is updated regularly.

“We continue to use all the tools we have available to help keep supply available for patients and will provide public updates regarding the Adderall shortage,” the FDA said.

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

Women with repeated attempts at weight loss, even if the weight is regained, have modestly greater weight loss at an obesity management clinic than women without such a history, data suggest.

In a retrospective study of data for more than 11,000 participants in a weight-management program, the frequency of weight loss was significantly correlated with the total lifetime weight loss in men (r = 0.61, P < .0001) and women (r = 0.60, P < .0001).

“It should be harder for you to lose weight when you’re older, as opposed to younger. That’s just biology,” study author Sean Wharton, MD, PharmD, medical director of the Wharton Medical Clinic, Burlington, Ont., told this news organization. But older people “have practiced a whole lot more than younger people. That’s probably one of the big things” in their favor, he added.

Dr. Wharton also is a clinical adjunct professor at York University, Toronto, and the lead author of 2020 Canadian clinical practice guidelines on obesity.

The current data were published in Obesity.
 

Practice makes perfect?

The prevalence of obesity is increasing. It is uncertain whether frequent weight losses help or hinder future weight-loss attempts. The effect of age at overweight on future weight loss attempts is also unclear.

To examine these questions, the current researchers analyzed the experiences of patients with obesity treated at the Wharton Medical Clinic Weight Management Program, Hamilton, Ont. At enrollment, participants responded to a questionnaire that elicited information about basic demographics, past weight loss and health practices, medical history, and family medical history. Patients did not receive any stipend for their participation and consented to the use of their medical data for research purposes. The investigators assessed weight change through a retrospective review of electronic medical records.

The study examined a data set that included 36,124 patients who were predominantly White, middle-aged women. “Although this is reflective of the demographic that is most commonly seeking obesity management in North America, the applicability of these findings to other groups is unclear,” wrote the investigators.

As a group, women under age 40 lost 1.7 kg, while those from ages 40 to 60 lost 3.2 kg, and women older than 60 lost 4.2 kg. Weight loss among men was greater and followed a similar pattern. Men under age 40 lost 3.0 kg, those between ages 40 and 60 lost 4.2 kg, and those older than 60 lost 5.2 kg.

To examine how long participants had been trying to lose weight, the investigators analyzed their age of overweight onset. Most participants reported having become overweight before age 40 and having lost at least 4.5 kg at least once in their lifetime. Older women with a longer history of losing weight had better results during the study.

In middle-aged and older women, but not men or younger women, earlier age of overweight onset and lifetime weight loss were associated with modestly greater weight loss at the clinic. When the researchers assessed women age 60 and older, they found that those who had an age of overweight onset before age 10 lost 4.9 kg on average, while those whose age of overweight onset was between ages 20 and 39 lost 4.3 kg. Women with an age of overweight onset above 40 had a weight loss of 3.5 kg.

The finding of greater weight loss in older women who were experienced in dieting was surprising, said Dr. Wharton. It may reflect the effects of perseverance and lifestyle changes. “The other thing is that [older women] also have more time. They have more availability. They make more appointments. They have the ability to be more focused,” said Dr. Wharton.

The Wharton Medical Clinic operates within the Ontario Health Insurance Plan, and all services are provided at no charge to the patient, which may reduce the selection bias against patients with low socioeconomic status, wrote the investigators.
 

Inclusive population

Lesley D. Lutes, PhD, director of the Center for Obesity and Well-Being Research Excellence (CORE) at the University of British Columbia, Vancouver, said that one of its strengths was its reflection of real-world experience.

Too often, study populations do not reflect well the experiences of people battling obesity, she added. Many potential participants are excluded because of common medical comorbidities such as heart conditions. “So, you don’t see the real-world outcomes for the majority of people” from these studies, said Dr. Lutes.

Furthermore, researchers sometimes draw conclusions about obesity based on data that draws from only a “tiny slice” of the group of patients who can qualify for studies, she added. The resulting recommendations may not suit most patients.

In contrast, the current research was based on a more inclusive set of patient data. “That was an incredible strength of this study, that there [were] no exclusionary criteria” in terms of medical conditions, she said.

No outside funding for the study was reported. Dr. Wharton is the medical director of the Wharton Medical Clinic.

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

Women with repeated attempts at weight loss, even if the weight is regained, have modestly greater weight loss at an obesity management clinic than women without such a history, data suggest.

In a retrospective study of data for more than 11,000 participants in a weight-management program, the frequency of weight loss was significantly correlated with the total lifetime weight loss in men (r = 0.61, P < .0001) and women (r = 0.60, P < .0001).

“It should be harder for you to lose weight when you’re older, as opposed to younger. That’s just biology,” study author Sean Wharton, MD, PharmD, medical director of the Wharton Medical Clinic, Burlington, Ont., told this news organization. But older people “have practiced a whole lot more than younger people. That’s probably one of the big things” in their favor, he added.

Dr. Wharton also is a clinical adjunct professor at York University, Toronto, and the lead author of 2020 Canadian clinical practice guidelines on obesity.

The current data were published in Obesity.
 

Practice makes perfect?

The prevalence of obesity is increasing. It is uncertain whether frequent weight losses help or hinder future weight-loss attempts. The effect of age at overweight on future weight loss attempts is also unclear.

To examine these questions, the current researchers analyzed the experiences of patients with obesity treated at the Wharton Medical Clinic Weight Management Program, Hamilton, Ont. At enrollment, participants responded to a questionnaire that elicited information about basic demographics, past weight loss and health practices, medical history, and family medical history. Patients did not receive any stipend for their participation and consented to the use of their medical data for research purposes. The investigators assessed weight change through a retrospective review of electronic medical records.

The study examined a data set that included 36,124 patients who were predominantly White, middle-aged women. “Although this is reflective of the demographic that is most commonly seeking obesity management in North America, the applicability of these findings to other groups is unclear,” wrote the investigators.

As a group, women under age 40 lost 1.7 kg, while those from ages 40 to 60 lost 3.2 kg, and women older than 60 lost 4.2 kg. Weight loss among men was greater and followed a similar pattern. Men under age 40 lost 3.0 kg, those between ages 40 and 60 lost 4.2 kg, and those older than 60 lost 5.2 kg.

To examine how long participants had been trying to lose weight, the investigators analyzed their age of overweight onset. Most participants reported having become overweight before age 40 and having lost at least 4.5 kg at least once in their lifetime. Older women with a longer history of losing weight had better results during the study.

In middle-aged and older women, but not men or younger women, earlier age of overweight onset and lifetime weight loss were associated with modestly greater weight loss at the clinic. When the researchers assessed women age 60 and older, they found that those who had an age of overweight onset before age 10 lost 4.9 kg on average, while those whose age of overweight onset was between ages 20 and 39 lost 4.3 kg. Women with an age of overweight onset above 40 had a weight loss of 3.5 kg.

The finding of greater weight loss in older women who were experienced in dieting was surprising, said Dr. Wharton. It may reflect the effects of perseverance and lifestyle changes. “The other thing is that [older women] also have more time. They have more availability. They make more appointments. They have the ability to be more focused,” said Dr. Wharton.

The Wharton Medical Clinic operates within the Ontario Health Insurance Plan, and all services are provided at no charge to the patient, which may reduce the selection bias against patients with low socioeconomic status, wrote the investigators.
 

Inclusive population

Lesley D. Lutes, PhD, director of the Center for Obesity and Well-Being Research Excellence (CORE) at the University of British Columbia, Vancouver, said that one of its strengths was its reflection of real-world experience.

Too often, study populations do not reflect well the experiences of people battling obesity, she added. Many potential participants are excluded because of common medical comorbidities such as heart conditions. “So, you don’t see the real-world outcomes for the majority of people” from these studies, said Dr. Lutes.

Furthermore, researchers sometimes draw conclusions about obesity based on data that draws from only a “tiny slice” of the group of patients who can qualify for studies, she added. The resulting recommendations may not suit most patients.

In contrast, the current research was based on a more inclusive set of patient data. “That was an incredible strength of this study, that there [were] no exclusionary criteria” in terms of medical conditions, she said.

No outside funding for the study was reported. Dr. Wharton is the medical director of the Wharton Medical Clinic.

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

Women with repeated attempts at weight loss, even if the weight is regained, have modestly greater weight loss at an obesity management clinic than women without such a history, data suggest.

In a retrospective study of data for more than 11,000 participants in a weight-management program, the frequency of weight loss was significantly correlated with the total lifetime weight loss in men (r = 0.61, P < .0001) and women (r = 0.60, P < .0001).

“It should be harder for you to lose weight when you’re older, as opposed to younger. That’s just biology,” study author Sean Wharton, MD, PharmD, medical director of the Wharton Medical Clinic, Burlington, Ont., told this news organization. But older people “have practiced a whole lot more than younger people. That’s probably one of the big things” in their favor, he added.

Dr. Wharton also is a clinical adjunct professor at York University, Toronto, and the lead author of 2020 Canadian clinical practice guidelines on obesity.

The current data were published in Obesity.
 

Practice makes perfect?

The prevalence of obesity is increasing. It is uncertain whether frequent weight losses help or hinder future weight-loss attempts. The effect of age at overweight on future weight loss attempts is also unclear.

To examine these questions, the current researchers analyzed the experiences of patients with obesity treated at the Wharton Medical Clinic Weight Management Program, Hamilton, Ont. At enrollment, participants responded to a questionnaire that elicited information about basic demographics, past weight loss and health practices, medical history, and family medical history. Patients did not receive any stipend for their participation and consented to the use of their medical data for research purposes. The investigators assessed weight change through a retrospective review of electronic medical records.

The study examined a data set that included 36,124 patients who were predominantly White, middle-aged women. “Although this is reflective of the demographic that is most commonly seeking obesity management in North America, the applicability of these findings to other groups is unclear,” wrote the investigators.

As a group, women under age 40 lost 1.7 kg, while those from ages 40 to 60 lost 3.2 kg, and women older than 60 lost 4.2 kg. Weight loss among men was greater and followed a similar pattern. Men under age 40 lost 3.0 kg, those between ages 40 and 60 lost 4.2 kg, and those older than 60 lost 5.2 kg.

To examine how long participants had been trying to lose weight, the investigators analyzed their age of overweight onset. Most participants reported having become overweight before age 40 and having lost at least 4.5 kg at least once in their lifetime. Older women with a longer history of losing weight had better results during the study.

In middle-aged and older women, but not men or younger women, earlier age of overweight onset and lifetime weight loss were associated with modestly greater weight loss at the clinic. When the researchers assessed women age 60 and older, they found that those who had an age of overweight onset before age 10 lost 4.9 kg on average, while those whose age of overweight onset was between ages 20 and 39 lost 4.3 kg. Women with an age of overweight onset above 40 had a weight loss of 3.5 kg.

The finding of greater weight loss in older women who were experienced in dieting was surprising, said Dr. Wharton. It may reflect the effects of perseverance and lifestyle changes. “The other thing is that [older women] also have more time. They have more availability. They make more appointments. They have the ability to be more focused,” said Dr. Wharton.

The Wharton Medical Clinic operates within the Ontario Health Insurance Plan, and all services are provided at no charge to the patient, which may reduce the selection bias against patients with low socioeconomic status, wrote the investigators.
 

Inclusive population

Lesley D. Lutes, PhD, director of the Center for Obesity and Well-Being Research Excellence (CORE) at the University of British Columbia, Vancouver, said that one of its strengths was its reflection of real-world experience.

Too often, study populations do not reflect well the experiences of people battling obesity, she added. Many potential participants are excluded because of common medical comorbidities such as heart conditions. “So, you don’t see the real-world outcomes for the majority of people” from these studies, said Dr. Lutes.

Furthermore, researchers sometimes draw conclusions about obesity based on data that draws from only a “tiny slice” of the group of patients who can qualify for studies, she added. The resulting recommendations may not suit most patients.

In contrast, the current research was based on a more inclusive set of patient data. “That was an incredible strength of this study, that there [were] no exclusionary criteria” in terms of medical conditions, she said.

No outside funding for the study was reported. Dr. Wharton is the medical director of the Wharton Medical Clinic.

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

Babies born from the 37th week of pregnancy who are mild to moderately small for gestational age (SGA) could benefit from monitoring to check for developmental problems, a study suggested.

A team of researchers at Coventry (England) University found that birth weight below the 25th percentile was associated with more developmental concerns in early childhood than a weight between the 25th and 74th percentile.

Those difficulties were apparent at percentiles higher than the conventional threshold defining SGA, they noted.

Low and high extremes of birth weight have been associated with adverse pregnancy and neonatal health outcomes, but little is known about the effects on motor skills, socialization, language, and other developmental markers for the entire range of birth weights for nonpremature babies.
 

Study linked health databases to child assessment results

To find out more, researchers conducted a population-based cohort study of 686,284 singleton infants born from 37 weeks of gestation, linking pregnancy and birth records from health databases covering all of Scotland to child development assessments carried out between the ages of 2 and 3.5 years.

The researchers looked for associations between birth weight and early childhood developmental concerns, taking into account confounders, such as maternal age, the mother’s medical history during pregnancy, early pregnancy body mass index, deprivation, ethnicity, alcohol use, and smoking history.

The study, published in the open access journal PLOS Medicine, found that babies born below the 25th percentile for birth weight had a higher risk of developmental concerns, compared with babies born between the 25th and 74th percentiles, with the infants who had the lowest birth weight most at risk of later developmental difficulties.

Those born between the 10th and 24th percentile had a relative risk of 1.07 (95% confidence interval, 1.03-1.12; P < .001); between the 3rd and 9th percentile, the RR was 1.18 (95% CI, 1.12-1.25, P < .001), and below the 3rd percentile the RR was 1.37 (95% CI, 1.24-1.50; P < .001).

No substantial increase in the risk of early childhood developmental concerns was identified for larger birth weight categories in the 75th-89th percentile range, the researchers reported.
 

Monitoring and support

The researchers concluded that having mild to moderate SGA “is an unrecognized, potentially important contributor to the prevalence of developmental concerns.”

Before this study, babies below the 10th percentile were usually considered at risk for developmental concerns. However, the investigation found a greater number of babies within the 10th-24th percentile range of birth weights with these issues, simply because there were a larger number of babies within that population.

Abiodun Adanikin, MBBS, PhD, MPH, of Coventry University’s Centre for Healthcare Research, and study first author, said: “Though it is mostly unrecognized, babies who are mild to moderately small at birth are key contributors to the burden of childhood developmental concerns. They may need closer monitoring and increased support to reduce the risk of developmental concerns.”

The study also involved colleagues from the University of Bristol (England), the University of Glasgow, the University of Cambridge (England), and Queen Mary University of London.

This work was supported by a Wellbeing of Women Research Grant. One author has received research support from Roche Diagnostics, GSK, Illumina, and Sera Prognostics (fetal growth restriction, preeclampsia and preterm birth). He has been a paid consultant to GSK (preterm birth) and is a member of a Data Monitoring Committee for GSK trials of RSV vaccination in pregnancy. He is one of three named inventors on a patent application filed by Cambridge Enterprise for novel predictive test for fetal growth disorder. He is an academic editor on PLOS Medicine’s editorial board. The authors declare no other competing interest.

A version of this article first appeared on Medscape UK.

Babies born from the 37th week of pregnancy who are mild to moderately small for gestational age (SGA) could benefit from monitoring to check for developmental problems, a study suggested.

A team of researchers at Coventry (England) University found that birth weight below the 25th percentile was associated with more developmental concerns in early childhood than a weight between the 25th and 74th percentile.

Those difficulties were apparent at percentiles higher than the conventional threshold defining SGA, they noted.

Low and high extremes of birth weight have been associated with adverse pregnancy and neonatal health outcomes, but little is known about the effects on motor skills, socialization, language, and other developmental markers for the entire range of birth weights for nonpremature babies.
 

Study linked health databases to child assessment results

To find out more, researchers conducted a population-based cohort study of 686,284 singleton infants born from 37 weeks of gestation, linking pregnancy and birth records from health databases covering all of Scotland to child development assessments carried out between the ages of 2 and 3.5 years.

The researchers looked for associations between birth weight and early childhood developmental concerns, taking into account confounders, such as maternal age, the mother’s medical history during pregnancy, early pregnancy body mass index, deprivation, ethnicity, alcohol use, and smoking history.

The study, published in the open access journal PLOS Medicine, found that babies born below the 25th percentile for birth weight had a higher risk of developmental concerns, compared with babies born between the 25th and 74th percentiles, with the infants who had the lowest birth weight most at risk of later developmental difficulties.

Those born between the 10th and 24th percentile had a relative risk of 1.07 (95% confidence interval, 1.03-1.12; P < .001); between the 3rd and 9th percentile, the RR was 1.18 (95% CI, 1.12-1.25, P < .001), and below the 3rd percentile the RR was 1.37 (95% CI, 1.24-1.50; P < .001).

No substantial increase in the risk of early childhood developmental concerns was identified for larger birth weight categories in the 75th-89th percentile range, the researchers reported.
 

Monitoring and support

The researchers concluded that having mild to moderate SGA “is an unrecognized, potentially important contributor to the prevalence of developmental concerns.”

Before this study, babies below the 10th percentile were usually considered at risk for developmental concerns. However, the investigation found a greater number of babies within the 10th-24th percentile range of birth weights with these issues, simply because there were a larger number of babies within that population.

Abiodun Adanikin, MBBS, PhD, MPH, of Coventry University’s Centre for Healthcare Research, and study first author, said: “Though it is mostly unrecognized, babies who are mild to moderately small at birth are key contributors to the burden of childhood developmental concerns. They may need closer monitoring and increased support to reduce the risk of developmental concerns.”

The study also involved colleagues from the University of Bristol (England), the University of Glasgow, the University of Cambridge (England), and Queen Mary University of London.

This work was supported by a Wellbeing of Women Research Grant. One author has received research support from Roche Diagnostics, GSK, Illumina, and Sera Prognostics (fetal growth restriction, preeclampsia and preterm birth). He has been a paid consultant to GSK (preterm birth) and is a member of a Data Monitoring Committee for GSK trials of RSV vaccination in pregnancy. He is one of three named inventors on a patent application filed by Cambridge Enterprise for novel predictive test for fetal growth disorder. He is an academic editor on PLOS Medicine’s editorial board. The authors declare no other competing interest.

A version of this article first appeared on Medscape UK.

Babies born from the 37th week of pregnancy who are mild to moderately small for gestational age (SGA) could benefit from monitoring to check for developmental problems, a study suggested.

A team of researchers at Coventry (England) University found that birth weight below the 25th percentile was associated with more developmental concerns in early childhood than a weight between the 25th and 74th percentile.

Those difficulties were apparent at percentiles higher than the conventional threshold defining SGA, they noted.

Low and high extremes of birth weight have been associated with adverse pregnancy and neonatal health outcomes, but little is known about the effects on motor skills, socialization, language, and other developmental markers for the entire range of birth weights for nonpremature babies.
 

Study linked health databases to child assessment results

To find out more, researchers conducted a population-based cohort study of 686,284 singleton infants born from 37 weeks of gestation, linking pregnancy and birth records from health databases covering all of Scotland to child development assessments carried out between the ages of 2 and 3.5 years.

The researchers looked for associations between birth weight and early childhood developmental concerns, taking into account confounders, such as maternal age, the mother’s medical history during pregnancy, early pregnancy body mass index, deprivation, ethnicity, alcohol use, and smoking history.

The study, published in the open access journal PLOS Medicine, found that babies born below the 25th percentile for birth weight had a higher risk of developmental concerns, compared with babies born between the 25th and 74th percentiles, with the infants who had the lowest birth weight most at risk of later developmental difficulties.

Those born between the 10th and 24th percentile had a relative risk of 1.07 (95% confidence interval, 1.03-1.12; P < .001); between the 3rd and 9th percentile, the RR was 1.18 (95% CI, 1.12-1.25, P < .001), and below the 3rd percentile the RR was 1.37 (95% CI, 1.24-1.50; P < .001).

No substantial increase in the risk of early childhood developmental concerns was identified for larger birth weight categories in the 75th-89th percentile range, the researchers reported.
 

Monitoring and support

The researchers concluded that having mild to moderate SGA “is an unrecognized, potentially important contributor to the prevalence of developmental concerns.”

Before this study, babies below the 10th percentile were usually considered at risk for developmental concerns. However, the investigation found a greater number of babies within the 10th-24th percentile range of birth weights with these issues, simply because there were a larger number of babies within that population.

Abiodun Adanikin, MBBS, PhD, MPH, of Coventry University’s Centre for Healthcare Research, and study first author, said: “Though it is mostly unrecognized, babies who are mild to moderately small at birth are key contributors to the burden of childhood developmental concerns. They may need closer monitoring and increased support to reduce the risk of developmental concerns.”

The study also involved colleagues from the University of Bristol (England), the University of Glasgow, the University of Cambridge (England), and Queen Mary University of London.

This work was supported by a Wellbeing of Women Research Grant. One author has received research support from Roche Diagnostics, GSK, Illumina, and Sera Prognostics (fetal growth restriction, preeclampsia and preterm birth). He has been a paid consultant to GSK (preterm birth) and is a member of a Data Monitoring Committee for GSK trials of RSV vaccination in pregnancy. He is one of three named inventors on a patent application filed by Cambridge Enterprise for novel predictive test for fetal growth disorder. He is an academic editor on PLOS Medicine’s editorial board. The authors declare no other competing interest.

A version of this article first appeared on Medscape UK.

Home-based transcranial direct current stimulation with real-time supervision significantly improved clinical symptoms of major depressive disorder, based on data from 26 individuals.

Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.

Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.

“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.

The researchers proposed that tDCS could be provided at home under real-time remote supervision.

In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.

The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.

Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.

The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.

All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”

The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”

However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.

The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
 

Home-based transcranial direct current stimulation with real-time supervision significantly improved clinical symptoms of major depressive disorder, based on data from 26 individuals.

Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.

Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.

“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.

The researchers proposed that tDCS could be provided at home under real-time remote supervision.

In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.

The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.

Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.

The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.

All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”

The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”

However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.

The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.
 

Home-based transcranial direct current stimulation with real-time supervision significantly improved clinical symptoms of major depressive disorder, based on data from 26 individuals.

Major depressive disorder (MDD) remains a leading cause of disability and a significant predictor of suicide worldwide, Rachel D. Woodham, PhD, of the University of East London and colleagues wrote.

Transcranial direct current stimulation (tDCS) has demonstrated effectiveness as a noninvasive therapy for MDD, but requires frequent sessions, and repeat visits to treatment centers are a barrier for many patients, they noted. The tDCS procedure involves delivery of a weak direct electric current via placement of electrodes, usually with the anode over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex, suborbital, or frontotemporal region.

“The current changes neuronal membrane potential and facilitates discharge,” but “in contrast to rTMS and ECT, tDCS does not directly trigger an action potential,” the researchers wrote. The most common side effects reported with tDCS are tingling, itching, burning sensation, skin redness or headache.

The researchers proposed that tDCS could be provided at home under real-time remote supervision.

In an open-label feasibility study published in the Journal of Psychiatric Research, they recruited 26 adults with MDD in current depressive episodes of moderate to severe severity. In addition to maintaining their current treatment regimens of medication, psychotherapy, or cognitive behavioral therapy, participants used tDCS at home in 30-minute sessions, for a total of 21 sessions over 6 weeks. A researcher was present in person or on a real-time video call for each at-home session.

The primary outcome of Hamilton Rating Scale for Depression (HAMD) score improved significantly, from a mean of 19.12 at baseline to 5.33 after 6 weeks. At 3 months, the mean HAMD score was 5.65, and 78.2% of patients met the criteria for clinical remission (HAMD score less than 9). At 6 months, patients maintained this improvement, with a mean HAMD score of 5.43 and 73.9% of the participants in clinical remission. The majority of participants (24 of 26) completed the full 6-week treatment.

Clinical assessments were conducted at baseline, at the end of the 6-week treatment period, at 3 months, and at 6 months, and included not only the HAMD, but also the Hamilton Anxiety Rating Scale (HAMA), Sheehan Disability Scale (SDS), Patient Health Questionnaire–9 (PHQ-9), and Young Mania Rating Scale. All participants showed significant improvements in HAMA, SDS, and PHQ-9 scores from baseline that endured from the end of the treatment period to the 6 months’ follow-up.

The tDCS involved a bilateral frontal montage, F3 anode, F4 cathode, 2mA, and two different devices were used.

All participants reported the acceptability of at-home tDCS as either “very acceptable” or “quite acceptable.”

The results were limited by the open-label feasibility design and lack of a sham control treatment; therefore, the findings of efficacy are preliminary, the researchers emphasized. “Having real-time supervision for each session likely contributed to symptom improvement.”

However, the results support the feasibility of at-home tDCS to improve outcomes both short- and long-term in patients with moderate to severe MDD, the researchers said. Larger, sham-controlled trials are needed to show efficacy, and additional assessment of feasibility should include the use of app-based devices, which may be more feasible for individuals with lower socioeconomic status.

The study received no outside funding. The study was supported by the Rosetrees Trust. The researchers had no financial conflicts to disclose.