MDedge Endocrinology

Patients who receive parathyroidectomy for mild primary hyperparathyroidism show no benefits in survival or morbidity, including fractures, cancer, or cardiovascular outcomes over more than 10 years, compared with those not receiving the surgery, results from a randomized, prospective trial show.

“In contrast to existing data showing increased mortality and cardiovascular morbidity in mild primary hyperparathyroidism, we did not find any treatment effect of parathyroidectomy on these important clinical endpoints,” report the authors of the study, published in the Annals of Internal Medicine.
 

Reason to evaluate and revise current recommendations?

With mild primary hyperparathyroidism becoming the predominant form of hyperparathyroidism, the results suggest rethinking the current recommendations for the condition, the study authors note. 

“Over the years, more active management of mild primary hyperparathyroidism has been recommended, with a widening of criteria for parathyroidectomy,” they write.

“With the low number of kidney stones (n = 5) and no effect of parathyroidectomy on fractures, there may be a need to evaluate and potentially revise the current recommendations.”

The authors of an accompanying editorial agree that “the [results] provide a strong rationale for nonoperative management of patients with mild primary hyperparathyroidism.”

“The findings suggest that most patients can be managed nonoperatively, with monitoring of serum calcium levels every 1 to 2 years or if symptoms occur,” write the editorial authors, Mark J. Bolland, PhD, and Andrew Grey, MD, of the department of medicine, University of Auckland, New Zealand.

Although parathyroidectomy is recommended for the treatment in patients with hyperparathyroidism with severe hypercalcemia or overt symptoms, there has been debate on the long-term benefits of surgery among those with milder cases.  

Most previous studies that have shown benefits, such as reductions in the risk of fracture with parathyroidectomy, have importantly not distinguished between mild and more severe primary hyperparathyroidism, the authors note.
 

No significant differences in mortality between surgery, nonsurgery groups

For the Scandinavian Investigation of Primary Hyperparathyroidism (SIPH) trial, first author Mikkel Pretorius, MD, Oslo University Hospital and Faculty of Medicine, University of Oslo, and colleagues enrolled 191 patients between 1998 and 2005 in Sweden, Norway, and Denmark, who were aged 50-80 years and had mild primary hyperparathyroidism, defined as serum calcium levels of 10.42-11.22 mg/dL.

Participants were randomized to receive surgery (n = 95) or nonoperative observation without intervention (n = 96).

After a 10-year follow-up, 129 patients had completed the final visit. The overall death rate was 7.6%, and, with eight deaths in the surgery group and seven in the nonsurgery group, there were no significant differences between groups in terms of mortality (HR, 1.17; P = .76).

During an extended observation period that lasted until 2018, mortality rates increased by 23%, but with a relatively even distribution of 24 deaths in the surgery group and 20 among those with no surgery.

Chronic hypercalcemia related to primary hyperparathyroidism has been debated as being associated with an increased risk of cardiovascular disease or cancer, however, “the absolute numbers for these and the other disease-specific causes of death were nearly identical between groups,” the authors write, with 17 deaths from cardiovascular disease, eight from cancer, and eight from cerebrovascular disease.

In terms of morbidity, including cardiovascular events, cerebrovascular events, cancer, peripheral fractures, and renal stones, there were 101 events overall, with 52 in the parathyroidectomy group and 49 in the nonsurgery group, which again, was not a significant difference.

Sixteen vertebral fractures occurred overall in 14 patients, which were evenly split at seven patients in each group.

The authors note that “the incidence of peripheral fractures for women in our study was around 2,900 per 100,000 person-years, in the same range as for 70-year-old women in a study in Gothenburg, Sweden (about 2,600 per 100,000 person-years).”

There were no between-group differences in terms of time to death or first morbidity event for any of the prespecified events.

Of the 96 patients originally assigned to the nonsurgery group, 17 (18%) had surgery during follow-up, including three for serious hypercalcemia, three by their own choice, two for decreasing bone density, one for kidney stones, and the others for unclear or unrelated reasons.

Study limitations include that only 26 men (13 in each group) were included, and only 16 completed the study. “The external validity for men based on this study is therefore limited,” the authors note.

And although most people with primary hyperparathyroidism are adults, the older age of participants suggests the results should not be generalized to younger patients with benign parathyroid tumors.

The editorialists note that age should be one of the few factors that may, indeed, suggest appropriate candidates for parathyroidectomy.

“Younger patients (aged < 50 years) may have more aggressive disease,” they explain.

In addition, “patients with serum calcium levels above 3 mmol/L (> 12 mg/dL) are at greater risk for symptomatic hypercalcemia, and patients with a recent history of kidney stones may have fewer future stones after surgical cure.”

“Yet, such patients are a small minority of those with primary hyperparathyroidism,” they note.

The study authors underscore that “our data add evidence to guide the decisionmaking process in deliberative dialogue between clinicians and patients.”

The study received funding from Swedish government grants, the Norwegian Research Council, and the South-Eastern Norway Regional Health Authority.

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

Patients who receive parathyroidectomy for mild primary hyperparathyroidism show no benefits in survival or morbidity, including fractures, cancer, or cardiovascular outcomes over more than 10 years, compared with those not receiving the surgery, results from a randomized, prospective trial show.

“In contrast to existing data showing increased mortality and cardiovascular morbidity in mild primary hyperparathyroidism, we did not find any treatment effect of parathyroidectomy on these important clinical endpoints,” report the authors of the study, published in the Annals of Internal Medicine.
 

Reason to evaluate and revise current recommendations?

With mild primary hyperparathyroidism becoming the predominant form of hyperparathyroidism, the results suggest rethinking the current recommendations for the condition, the study authors note. 

“Over the years, more active management of mild primary hyperparathyroidism has been recommended, with a widening of criteria for parathyroidectomy,” they write.

“With the low number of kidney stones (n = 5) and no effect of parathyroidectomy on fractures, there may be a need to evaluate and potentially revise the current recommendations.”

The authors of an accompanying editorial agree that “the [results] provide a strong rationale for nonoperative management of patients with mild primary hyperparathyroidism.”

“The findings suggest that most patients can be managed nonoperatively, with monitoring of serum calcium levels every 1 to 2 years or if symptoms occur,” write the editorial authors, Mark J. Bolland, PhD, and Andrew Grey, MD, of the department of medicine, University of Auckland, New Zealand.

Although parathyroidectomy is recommended for the treatment in patients with hyperparathyroidism with severe hypercalcemia or overt symptoms, there has been debate on the long-term benefits of surgery among those with milder cases.  

Most previous studies that have shown benefits, such as reductions in the risk of fracture with parathyroidectomy, have importantly not distinguished between mild and more severe primary hyperparathyroidism, the authors note.
 

No significant differences in mortality between surgery, nonsurgery groups

For the Scandinavian Investigation of Primary Hyperparathyroidism (SIPH) trial, first author Mikkel Pretorius, MD, Oslo University Hospital and Faculty of Medicine, University of Oslo, and colleagues enrolled 191 patients between 1998 and 2005 in Sweden, Norway, and Denmark, who were aged 50-80 years and had mild primary hyperparathyroidism, defined as serum calcium levels of 10.42-11.22 mg/dL.

Participants were randomized to receive surgery (n = 95) or nonoperative observation without intervention (n = 96).

After a 10-year follow-up, 129 patients had completed the final visit. The overall death rate was 7.6%, and, with eight deaths in the surgery group and seven in the nonsurgery group, there were no significant differences between groups in terms of mortality (HR, 1.17; P = .76).

During an extended observation period that lasted until 2018, mortality rates increased by 23%, but with a relatively even distribution of 24 deaths in the surgery group and 20 among those with no surgery.

Chronic hypercalcemia related to primary hyperparathyroidism has been debated as being associated with an increased risk of cardiovascular disease or cancer, however, “the absolute numbers for these and the other disease-specific causes of death were nearly identical between groups,” the authors write, with 17 deaths from cardiovascular disease, eight from cancer, and eight from cerebrovascular disease.

In terms of morbidity, including cardiovascular events, cerebrovascular events, cancer, peripheral fractures, and renal stones, there were 101 events overall, with 52 in the parathyroidectomy group and 49 in the nonsurgery group, which again, was not a significant difference.

Sixteen vertebral fractures occurred overall in 14 patients, which were evenly split at seven patients in each group.

The authors note that “the incidence of peripheral fractures for women in our study was around 2,900 per 100,000 person-years, in the same range as for 70-year-old women in a study in Gothenburg, Sweden (about 2,600 per 100,000 person-years).”

There were no between-group differences in terms of time to death or first morbidity event for any of the prespecified events.

Of the 96 patients originally assigned to the nonsurgery group, 17 (18%) had surgery during follow-up, including three for serious hypercalcemia, three by their own choice, two for decreasing bone density, one for kidney stones, and the others for unclear or unrelated reasons.

Study limitations include that only 26 men (13 in each group) were included, and only 16 completed the study. “The external validity for men based on this study is therefore limited,” the authors note.

And although most people with primary hyperparathyroidism are adults, the older age of participants suggests the results should not be generalized to younger patients with benign parathyroid tumors.

The editorialists note that age should be one of the few factors that may, indeed, suggest appropriate candidates for parathyroidectomy.

“Younger patients (aged < 50 years) may have more aggressive disease,” they explain.

In addition, “patients with serum calcium levels above 3 mmol/L (> 12 mg/dL) are at greater risk for symptomatic hypercalcemia, and patients with a recent history of kidney stones may have fewer future stones after surgical cure.”

“Yet, such patients are a small minority of those with primary hyperparathyroidism,” they note.

The study authors underscore that “our data add evidence to guide the decisionmaking process in deliberative dialogue between clinicians and patients.”

The study received funding from Swedish government grants, the Norwegian Research Council, and the South-Eastern Norway Regional Health Authority.

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

Patients who receive parathyroidectomy for mild primary hyperparathyroidism show no benefits in survival or morbidity, including fractures, cancer, or cardiovascular outcomes over more than 10 years, compared with those not receiving the surgery, results from a randomized, prospective trial show.

“In contrast to existing data showing increased mortality and cardiovascular morbidity in mild primary hyperparathyroidism, we did not find any treatment effect of parathyroidectomy on these important clinical endpoints,” report the authors of the study, published in the Annals of Internal Medicine.
 

Reason to evaluate and revise current recommendations?

With mild primary hyperparathyroidism becoming the predominant form of hyperparathyroidism, the results suggest rethinking the current recommendations for the condition, the study authors note. 

“Over the years, more active management of mild primary hyperparathyroidism has been recommended, with a widening of criteria for parathyroidectomy,” they write.

“With the low number of kidney stones (n = 5) and no effect of parathyroidectomy on fractures, there may be a need to evaluate and potentially revise the current recommendations.”

The authors of an accompanying editorial agree that “the [results] provide a strong rationale for nonoperative management of patients with mild primary hyperparathyroidism.”

“The findings suggest that most patients can be managed nonoperatively, with monitoring of serum calcium levels every 1 to 2 years or if symptoms occur,” write the editorial authors, Mark J. Bolland, PhD, and Andrew Grey, MD, of the department of medicine, University of Auckland, New Zealand.

Although parathyroidectomy is recommended for the treatment in patients with hyperparathyroidism with severe hypercalcemia or overt symptoms, there has been debate on the long-term benefits of surgery among those with milder cases.  

Most previous studies that have shown benefits, such as reductions in the risk of fracture with parathyroidectomy, have importantly not distinguished between mild and more severe primary hyperparathyroidism, the authors note.
 

No significant differences in mortality between surgery, nonsurgery groups

For the Scandinavian Investigation of Primary Hyperparathyroidism (SIPH) trial, first author Mikkel Pretorius, MD, Oslo University Hospital and Faculty of Medicine, University of Oslo, and colleagues enrolled 191 patients between 1998 and 2005 in Sweden, Norway, and Denmark, who were aged 50-80 years and had mild primary hyperparathyroidism, defined as serum calcium levels of 10.42-11.22 mg/dL.

Participants were randomized to receive surgery (n = 95) or nonoperative observation without intervention (n = 96).

After a 10-year follow-up, 129 patients had completed the final visit. The overall death rate was 7.6%, and, with eight deaths in the surgery group and seven in the nonsurgery group, there were no significant differences between groups in terms of mortality (HR, 1.17; P = .76).

During an extended observation period that lasted until 2018, mortality rates increased by 23%, but with a relatively even distribution of 24 deaths in the surgery group and 20 among those with no surgery.

Chronic hypercalcemia related to primary hyperparathyroidism has been debated as being associated with an increased risk of cardiovascular disease or cancer, however, “the absolute numbers for these and the other disease-specific causes of death were nearly identical between groups,” the authors write, with 17 deaths from cardiovascular disease, eight from cancer, and eight from cerebrovascular disease.

In terms of morbidity, including cardiovascular events, cerebrovascular events, cancer, peripheral fractures, and renal stones, there were 101 events overall, with 52 in the parathyroidectomy group and 49 in the nonsurgery group, which again, was not a significant difference.

Sixteen vertebral fractures occurred overall in 14 patients, which were evenly split at seven patients in each group.

The authors note that “the incidence of peripheral fractures for women in our study was around 2,900 per 100,000 person-years, in the same range as for 70-year-old women in a study in Gothenburg, Sweden (about 2,600 per 100,000 person-years).”

There were no between-group differences in terms of time to death or first morbidity event for any of the prespecified events.

Of the 96 patients originally assigned to the nonsurgery group, 17 (18%) had surgery during follow-up, including three for serious hypercalcemia, three by their own choice, two for decreasing bone density, one for kidney stones, and the others for unclear or unrelated reasons.

Study limitations include that only 26 men (13 in each group) were included, and only 16 completed the study. “The external validity for men based on this study is therefore limited,” the authors note.

And although most people with primary hyperparathyroidism are adults, the older age of participants suggests the results should not be generalized to younger patients with benign parathyroid tumors.

The editorialists note that age should be one of the few factors that may, indeed, suggest appropriate candidates for parathyroidectomy.

“Younger patients (aged < 50 years) may have more aggressive disease,” they explain.

In addition, “patients with serum calcium levels above 3 mmol/L (> 12 mg/dL) are at greater risk for symptomatic hypercalcemia, and patients with a recent history of kidney stones may have fewer future stones after surgical cure.”

“Yet, such patients are a small minority of those with primary hyperparathyroidism,” they note.

The study authors underscore that “our data add evidence to guide the decisionmaking process in deliberative dialogue between clinicians and patients.”

The study received funding from Swedish government grants, the Norwegian Research Council, and the South-Eastern Norway Regional Health Authority.

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

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Bariatric surgery can reduce the risk of long-term cardiovascular outcomes in older Medicare beneficiaries with obesity, a large new observational study in which a third of the patients were over age 65 years suggests.

Overall, patients who underwent bariatric surgery had 37% lower all-cause mortality and were significantly less likely to have admissions for new-onset heart failure (64% risk reduction), myocardial infarction (37% risk reduction), and ischemic stroke (29% risk reduction), compared with similar patients who received more conservative treatment, after a median of 4 years of follow-up, report Amgad Mentias, MD, MS, a clinical cardiologist at the Cleveland Clinic Foundation, Ohio, and colleagues.

The results were published in the Journal of the American College of Cardiology.

Previous studies on bariatric surgery outcomes have primarily focused on individuals from select health care networks or medical facilities with restricted coverage in the United States or on patients with diabetes, noted Tiffany M. Powell-Wiley, MD, MPH, of the National Institutes of Health’s National Heart, Lung, and Blood Institute, Bethesda, Maryland, and colleagues in an accompanying editorial.

Contemporary cohort of patients

“A lot of the studies showed long-term outcomes outside of the U.S., specifically in Europe,” Dr. Mentias added.

The aim of this study was to evaluate the long-term association between bariatric surgery and risk of adverse cardiovascular outcomes in a contemporary large cohort from the United States.

Older patients (> 65 years) and those without diabetes were looked at as specific subgroups.

The researchers assessed 189,770 patients. There were 94,885 matched patients in each cohort. Mean age was 62.33 years. Female patients comprised 70% of the cohort. The study group had an average BMI of 44.7 kg/m2.

The study cohort was matched 1:1. Participants were either part of a control group with obesity or a group of Medicare beneficiaries who had bariatric surgery between 2013 and 2019. Sex, propensity score matching on 87 clinical variables, age, and BMI were used to match patients.

Myocardial infarction, new-onset heart failure, ischemic stroke, and all-cause mortality were all study outcomes. As a sensitivity analysis, the study team conducted an instrumental variable assessment.

More specifically, the findings showed that bariatric surgery was linked with the following after a median follow-up of 4.0 years:

• Myocardial infarction (hazard ratio, 0.63; 95% confidence interval, 0.59-0.68)
• Stroke (HR, 0.71; 95% CI, 0.65-0.79)
• New-onset heart failure (HR, 0.46; 95% CI, 0.44-0.49)
• Reduced risk of death (9.2 vs. 14.7 per 1000 person-years; HR, 0.63; 95% CI, 0.60-0.66)

Findings for those over the age of 65 were similar – lower risks of all-cause mortality (HR, 0.64), new-onset heart failure (HR, 0.52), myocardial infarction (HR, 0.70), and stroke (HR, 0.76; all P < .001). Similar findings were shown in subgroup analyses in men and women and in patients with and without diabetes.

The study cohort primarily consisted of Medicare patients, which limits the generalizability of the data. Lack of data on medications taken for cardiovascular and weight loss purposes and potential coding errors because the information was gathered from an administrative database were all limitations of the study, the researchers note.

An additional limitation was that residual unmeasured confounders, particularly patient-focused physical, social, and mental support factors, could play a role in whether a patient opted to have bariatric surgery, the study authors note.

“Additional studies are needed to compare cardiovascular outcomes after bariatric surgery with weight loss medications like glucagon-like peptide-1 (GLP-1) analogues,” the researchers add.

This study was partially funded by philanthropic contributions by the Khouri family, Bailey family, and Haslam family to the Cleveland Clinic for co-author Dr. Milind Y. Desai’s research. Dr. Mentias has disclosed no relevant financial relationships. Dr. Powell-Wiley disclosed relationships with the National Institute on Minority Health and Health Disparities and the Division of Intramural Research of the National, Heart, Lung, and Blood Institute of the National Institutes of Health.

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

Bariatric surgery can reduce the risk of long-term cardiovascular outcomes in older Medicare beneficiaries with obesity, a large new observational study in which a third of the patients were over age 65 years suggests.

Overall, patients who underwent bariatric surgery had 37% lower all-cause mortality and were significantly less likely to have admissions for new-onset heart failure (64% risk reduction), myocardial infarction (37% risk reduction), and ischemic stroke (29% risk reduction), compared with similar patients who received more conservative treatment, after a median of 4 years of follow-up, report Amgad Mentias, MD, MS, a clinical cardiologist at the Cleveland Clinic Foundation, Ohio, and colleagues.

The results were published in the Journal of the American College of Cardiology.

Previous studies on bariatric surgery outcomes have primarily focused on individuals from select health care networks or medical facilities with restricted coverage in the United States or on patients with diabetes, noted Tiffany M. Powell-Wiley, MD, MPH, of the National Institutes of Health’s National Heart, Lung, and Blood Institute, Bethesda, Maryland, and colleagues in an accompanying editorial.

Contemporary cohort of patients

“A lot of the studies showed long-term outcomes outside of the U.S., specifically in Europe,” Dr. Mentias added.

The aim of this study was to evaluate the long-term association between bariatric surgery and risk of adverse cardiovascular outcomes in a contemporary large cohort from the United States.

Older patients (> 65 years) and those without diabetes were looked at as specific subgroups.

The researchers assessed 189,770 patients. There were 94,885 matched patients in each cohort. Mean age was 62.33 years. Female patients comprised 70% of the cohort. The study group had an average BMI of 44.7 kg/m2.

The study cohort was matched 1:1. Participants were either part of a control group with obesity or a group of Medicare beneficiaries who had bariatric surgery between 2013 and 2019. Sex, propensity score matching on 87 clinical variables, age, and BMI were used to match patients.

Myocardial infarction, new-onset heart failure, ischemic stroke, and all-cause mortality were all study outcomes. As a sensitivity analysis, the study team conducted an instrumental variable assessment.

More specifically, the findings showed that bariatric surgery was linked with the following after a median follow-up of 4.0 years:

• Myocardial infarction (hazard ratio, 0.63; 95% confidence interval, 0.59-0.68)
• Stroke (HR, 0.71; 95% CI, 0.65-0.79)
• New-onset heart failure (HR, 0.46; 95% CI, 0.44-0.49)
• Reduced risk of death (9.2 vs. 14.7 per 1000 person-years; HR, 0.63; 95% CI, 0.60-0.66)

Findings for those over the age of 65 were similar – lower risks of all-cause mortality (HR, 0.64), new-onset heart failure (HR, 0.52), myocardial infarction (HR, 0.70), and stroke (HR, 0.76; all P < .001). Similar findings were shown in subgroup analyses in men and women and in patients with and without diabetes.

The study cohort primarily consisted of Medicare patients, which limits the generalizability of the data. Lack of data on medications taken for cardiovascular and weight loss purposes and potential coding errors because the information was gathered from an administrative database were all limitations of the study, the researchers note.

An additional limitation was that residual unmeasured confounders, particularly patient-focused physical, social, and mental support factors, could play a role in whether a patient opted to have bariatric surgery, the study authors note.

“Additional studies are needed to compare cardiovascular outcomes after bariatric surgery with weight loss medications like glucagon-like peptide-1 (GLP-1) analogues,” the researchers add.

This study was partially funded by philanthropic contributions by the Khouri family, Bailey family, and Haslam family to the Cleveland Clinic for co-author Dr. Milind Y. Desai’s research. Dr. Mentias has disclosed no relevant financial relationships. Dr. Powell-Wiley disclosed relationships with the National Institute on Minority Health and Health Disparities and the Division of Intramural Research of the National, Heart, Lung, and Blood Institute of the National Institutes of Health.

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

Bariatric surgery can reduce the risk of long-term cardiovascular outcomes in older Medicare beneficiaries with obesity, a large new observational study in which a third of the patients were over age 65 years suggests.

Overall, patients who underwent bariatric surgery had 37% lower all-cause mortality and were significantly less likely to have admissions for new-onset heart failure (64% risk reduction), myocardial infarction (37% risk reduction), and ischemic stroke (29% risk reduction), compared with similar patients who received more conservative treatment, after a median of 4 years of follow-up, report Amgad Mentias, MD, MS, a clinical cardiologist at the Cleveland Clinic Foundation, Ohio, and colleagues.

The results were published in the Journal of the American College of Cardiology.

Previous studies on bariatric surgery outcomes have primarily focused on individuals from select health care networks or medical facilities with restricted coverage in the United States or on patients with diabetes, noted Tiffany M. Powell-Wiley, MD, MPH, of the National Institutes of Health’s National Heart, Lung, and Blood Institute, Bethesda, Maryland, and colleagues in an accompanying editorial.

Contemporary cohort of patients

“A lot of the studies showed long-term outcomes outside of the U.S., specifically in Europe,” Dr. Mentias added.

The aim of this study was to evaluate the long-term association between bariatric surgery and risk of adverse cardiovascular outcomes in a contemporary large cohort from the United States.

Older patients (> 65 years) and those without diabetes were looked at as specific subgroups.

The researchers assessed 189,770 patients. There were 94,885 matched patients in each cohort. Mean age was 62.33 years. Female patients comprised 70% of the cohort. The study group had an average BMI of 44.7 kg/m2.

The study cohort was matched 1:1. Participants were either part of a control group with obesity or a group of Medicare beneficiaries who had bariatric surgery between 2013 and 2019. Sex, propensity score matching on 87 clinical variables, age, and BMI were used to match patients.

Myocardial infarction, new-onset heart failure, ischemic stroke, and all-cause mortality were all study outcomes. As a sensitivity analysis, the study team conducted an instrumental variable assessment.

More specifically, the findings showed that bariatric surgery was linked with the following after a median follow-up of 4.0 years:

• Myocardial infarction (hazard ratio, 0.63; 95% confidence interval, 0.59-0.68)
• Stroke (HR, 0.71; 95% CI, 0.65-0.79)
• New-onset heart failure (HR, 0.46; 95% CI, 0.44-0.49)
• Reduced risk of death (9.2 vs. 14.7 per 1000 person-years; HR, 0.63; 95% CI, 0.60-0.66)

Findings for those over the age of 65 were similar – lower risks of all-cause mortality (HR, 0.64), new-onset heart failure (HR, 0.52), myocardial infarction (HR, 0.70), and stroke (HR, 0.76; all P < .001). Similar findings were shown in subgroup analyses in men and women and in patients with and without diabetes.

The study cohort primarily consisted of Medicare patients, which limits the generalizability of the data. Lack of data on medications taken for cardiovascular and weight loss purposes and potential coding errors because the information was gathered from an administrative database were all limitations of the study, the researchers note.

An additional limitation was that residual unmeasured confounders, particularly patient-focused physical, social, and mental support factors, could play a role in whether a patient opted to have bariatric surgery, the study authors note.

“Additional studies are needed to compare cardiovascular outcomes after bariatric surgery with weight loss medications like glucagon-like peptide-1 (GLP-1) analogues,” the researchers add.

This study was partially funded by philanthropic contributions by the Khouri family, Bailey family, and Haslam family to the Cleveland Clinic for co-author Dr. Milind Y. Desai’s research. Dr. Mentias has disclosed no relevant financial relationships. Dr. Powell-Wiley disclosed relationships with the National Institute on Minority Health and Health Disparities and the Division of Intramural Research of the National, Heart, Lung, and Blood Institute of the National Institutes of Health.

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

A scientific analysis of metabolites from plant-based-diets – especially those rich in whole grains, fruits, and vegetables – may in the future yield clues as to how such eating patterns lower the risk of type 2 diabetes, finds a new study of more than 8,000 people.

The research looked at healthy, unhealthy, and overall plant-based diets, but only metabolic profiles for the healthy and overall plant-based diets showed an inverse relationship with type 2 diabetes.

Lisovskaya/iStock/Getty Images Plus

A primarily “unhealthy” plant-based diet was one including mainly refined grains (e.g., white bread and pasta), fruit juices, potatoes, sugar-sweetened beverages, and sweets/desserts.

“Individual metabolites from consumption of polyphenol-rich plant foods like fruits, vegetables, coffee, and legumes are all closely linked to healthy plant-based diet and lower risk of diabetes,” lead author Frank Hu, MD, said in a press release.

Dr. Hu, of the department of nutrition at Harvard T.H. Chan School of Public Health, Boston, and colleagues reported their findings in Diabetologia.
 

High-throughput profiling of the metabolome

Given that an individual’s metabolic profile reflects their diet, there is a growing trend in nutritional research to use a technique called high-throughput metabolomics to profile biological samples.

The team conducted an analysis of blood plasma samples and dietary intake using food frequency questionnaires of 10,684 participants from three prospective cohorts (Nurses’ Health Study, Nurses’ Health Study II, and Health Professionals Follow-Up Study). Participants were predominantly White and middle-aged (mean age 54 years), with a mean body mass index of 25.6 kg/m².

Metabolite profile scores were generated from the blood samples, taken in the 1980s and 1990s, and matched to any cases of incident type 2 diabetes reported during follow-up, which ended in 2016-2017.

The team looked at three different plant-based diets – by definition, higher in plant foods and lower in animal foods – and further categorized them according to the actual foods consumed, to generate an overall plant diet index (PDI), a healthy PDI, or an unhealthy PDI.

In all, 8,827 participants completed the study, and 270 cases of diabetes were reported.

Multi-metabolite profiles were composed of 55 metabolites for the overall PDI, 93 metabolites for healthy PDI, and 75 metabolites for unhealthy PDI.

The findings are that metabolomics can be harnessed and “the identified metabolic profiles could be used to assess adherence to ... plant-based diets as part of type 2 diabetes prevention ... and provide new insights for future investigation,” the researchers concluded.

One coauthor received research support from the California Walnut Commission and Swiss ReManagement; another reported being a scientific consultant to LayerIV. The other authors have reported no relevant financial relationships.

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

A scientific analysis of metabolites from plant-based-diets – especially those rich in whole grains, fruits, and vegetables – may in the future yield clues as to how such eating patterns lower the risk of type 2 diabetes, finds a new study of more than 8,000 people.

The research looked at healthy, unhealthy, and overall plant-based diets, but only metabolic profiles for the healthy and overall plant-based diets showed an inverse relationship with type 2 diabetes.

Lisovskaya/iStock/Getty Images Plus

A primarily “unhealthy” plant-based diet was one including mainly refined grains (e.g., white bread and pasta), fruit juices, potatoes, sugar-sweetened beverages, and sweets/desserts.

“Individual metabolites from consumption of polyphenol-rich plant foods like fruits, vegetables, coffee, and legumes are all closely linked to healthy plant-based diet and lower risk of diabetes,” lead author Frank Hu, MD, said in a press release.

Dr. Hu, of the department of nutrition at Harvard T.H. Chan School of Public Health, Boston, and colleagues reported their findings in Diabetologia.
 

High-throughput profiling of the metabolome

Given that an individual’s metabolic profile reflects their diet, there is a growing trend in nutritional research to use a technique called high-throughput metabolomics to profile biological samples.

The team conducted an analysis of blood plasma samples and dietary intake using food frequency questionnaires of 10,684 participants from three prospective cohorts (Nurses’ Health Study, Nurses’ Health Study II, and Health Professionals Follow-Up Study). Participants were predominantly White and middle-aged (mean age 54 years), with a mean body mass index of 25.6 kg/m².

Metabolite profile scores were generated from the blood samples, taken in the 1980s and 1990s, and matched to any cases of incident type 2 diabetes reported during follow-up, which ended in 2016-2017.

The team looked at three different plant-based diets – by definition, higher in plant foods and lower in animal foods – and further categorized them according to the actual foods consumed, to generate an overall plant diet index (PDI), a healthy PDI, or an unhealthy PDI.

In all, 8,827 participants completed the study, and 270 cases of diabetes were reported.

Multi-metabolite profiles were composed of 55 metabolites for the overall PDI, 93 metabolites for healthy PDI, and 75 metabolites for unhealthy PDI.

The findings are that metabolomics can be harnessed and “the identified metabolic profiles could be used to assess adherence to ... plant-based diets as part of type 2 diabetes prevention ... and provide new insights for future investigation,” the researchers concluded.

One coauthor received research support from the California Walnut Commission and Swiss ReManagement; another reported being a scientific consultant to LayerIV. The other authors have reported no relevant financial relationships.

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

A scientific analysis of metabolites from plant-based-diets – especially those rich in whole grains, fruits, and vegetables – may in the future yield clues as to how such eating patterns lower the risk of type 2 diabetes, finds a new study of more than 8,000 people.

The research looked at healthy, unhealthy, and overall plant-based diets, but only metabolic profiles for the healthy and overall plant-based diets showed an inverse relationship with type 2 diabetes.

Lisovskaya/iStock/Getty Images Plus

A primarily “unhealthy” plant-based diet was one including mainly refined grains (e.g., white bread and pasta), fruit juices, potatoes, sugar-sweetened beverages, and sweets/desserts.

“Individual metabolites from consumption of polyphenol-rich plant foods like fruits, vegetables, coffee, and legumes are all closely linked to healthy plant-based diet and lower risk of diabetes,” lead author Frank Hu, MD, said in a press release.

Dr. Hu, of the department of nutrition at Harvard T.H. Chan School of Public Health, Boston, and colleagues reported their findings in Diabetologia.
 

High-throughput profiling of the metabolome

Given that an individual’s metabolic profile reflects their diet, there is a growing trend in nutritional research to use a technique called high-throughput metabolomics to profile biological samples.

The team conducted an analysis of blood plasma samples and dietary intake using food frequency questionnaires of 10,684 participants from three prospective cohorts (Nurses’ Health Study, Nurses’ Health Study II, and Health Professionals Follow-Up Study). Participants were predominantly White and middle-aged (mean age 54 years), with a mean body mass index of 25.6 kg/m².

Metabolite profile scores were generated from the blood samples, taken in the 1980s and 1990s, and matched to any cases of incident type 2 diabetes reported during follow-up, which ended in 2016-2017.

The team looked at three different plant-based diets – by definition, higher in plant foods and lower in animal foods – and further categorized them according to the actual foods consumed, to generate an overall plant diet index (PDI), a healthy PDI, or an unhealthy PDI.

In all, 8,827 participants completed the study, and 270 cases of diabetes were reported.

Multi-metabolite profiles were composed of 55 metabolites for the overall PDI, 93 metabolites for healthy PDI, and 75 metabolites for unhealthy PDI.

The findings are that metabolomics can be harnessed and “the identified metabolic profiles could be used to assess adherence to ... plant-based diets as part of type 2 diabetes prevention ... and provide new insights for future investigation,” the researchers concluded.

One coauthor received research support from the California Walnut Commission and Swiss ReManagement; another reported being a scientific consultant to LayerIV. The other authors have reported no relevant financial relationships.

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

A new study has found that aged black garlic (ABG) on top of dietary guidance lowers diastolic blood pressure (DBP) in men with moderately elevated cholesterol.

After 6 weeks, consumption of ABG with a high concentration of s-allyl-L-cystine (SAC) was associated with a nearly 6-mm Hg reduction in DBP in men. Other cardiovascular disease (CVD) risk factors were not significantly affected.

“The observed reduction in DBP by ABG extract was similar to the effects of dietary approaches, including the effects of the Dietary Approaches to Stop Hypertension(DASH) diet on BP,” say Rosa M. Valls, PhD, Universitat Rovira i Virgili, Reus, Spain, and colleagues.

“The potential beneficial effects of ABG may contribute to obtaining an optimal DBP” but were “better observed in men and in nonoptimal DBP populations,” they write in the study, published in Nutrients.

Pure SAC and aged garlics have shown healthy effects on multiple targets in in vitro and in vivo tests. However, previous studies in humans have not focused on ABG but rather on other types of aged garlic in patients with some type of CVD risk factor and suffered from methodologic or design weaknesses, the authors note.

To address this gap, Dr. Valls and colleagues randomly assigned 67 individuals with moderate hypercholesterolemia (defined as LDL levels of at least 115 mg/dL) to receive one ABG tablet (250 mg ABG extract/1.25 mg SAC) or placebo daily for 6 weeks. Following a 3-week washout, the groups were reversed and the new intervention continued for another 6 weeks.

Participants received dietary recommendations regarding CVD risk factors and had their dietary habits assessed through a 3-day food record at baseline and after 6 weeks during both treatments.

Individuals receiving lipid-lowering treatment or antihypertensives were excluded, as were those with a body mass index of 35 kg/m² or higher, those with a fasting blood glucose of at least 126 mg/dL, or active smokers.

There were no differences in baseline characteristics between the two groups. The mean systolic and diastolic pressures at baseline were 124/75 mm Hg in the ABG group and 121/74 mm Hg in the placebo group. Their mean age was 53 years.

Adherence with the protocol was “high” at 96.5% in both groups, and no adverse effects were reported.
 

Reduced risk of death from stroke, ischemic heart disease

Although no significant differences between ABG and placebo were observed at 3 weeks, the decline in DBP after consumption of the ABG extract became significant at 6 weeks (mean change, –3.7 mm Hg vs. –0.10 mm Hg; P = .007).

When stratified by sex and categories of DBP, the mean change in DBP after 6 weeks of ABG consumption was particularly prominent in men and in those with a baseline DBP of at least 75 mm Hg.

Small study

Commenting for this news organization, Linda Van Horn, PhD, RDN, professor and chief of the department of preventive medicine’s nutrition division, Northwestern University, Chicago, said that for many years, garlic has been “reported to be an adjunct to the benefits of a healthy eating pattern, with inconclusive results.”

She noted that ABG is “literally aged for many months to years, and the resulting concentrate is found higher in many organosulfur compounds and phytochemicals that suggest enhanced response.”

Dr. Van Horn, a member of the American Heart Association’s Nutrition Committee, who was not involved with the study, continued: “The data suggest that ABG that is much more highly concentrated than fresh or processed garlic might be helpful in lowering BP in certain subgroups, in this case men with higher BP.”

However, she cautioned, “these results are limited in a small study, and ... potential other issues, such as sodium, potassium, or other nutrients known to be associated with blood pressure, were not reported, thereby raising questions about the exclusivity of the ABG over other accompanying dietary factors.”

The study was funded by the Center for the Development of Industrial Technology of the Spanish Ministry of Science and Innovation. Two authors are employees of Pharmactive Biotech Products, SL (Madrid), which manufactured the ABG product, but neither played a role in any result or conclusion. The other authors and Dr. Van Horn report no relevant financial relationships.

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

A new study has found that aged black garlic (ABG) on top of dietary guidance lowers diastolic blood pressure (DBP) in men with moderately elevated cholesterol.

After 6 weeks, consumption of ABG with a high concentration of s-allyl-L-cystine (SAC) was associated with a nearly 6-mm Hg reduction in DBP in men. Other cardiovascular disease (CVD) risk factors were not significantly affected.

“The observed reduction in DBP by ABG extract was similar to the effects of dietary approaches, including the effects of the Dietary Approaches to Stop Hypertension(DASH) diet on BP,” say Rosa M. Valls, PhD, Universitat Rovira i Virgili, Reus, Spain, and colleagues.

“The potential beneficial effects of ABG may contribute to obtaining an optimal DBP” but were “better observed in men and in nonoptimal DBP populations,” they write in the study, published in Nutrients.

Pure SAC and aged garlics have shown healthy effects on multiple targets in in vitro and in vivo tests. However, previous studies in humans have not focused on ABG but rather on other types of aged garlic in patients with some type of CVD risk factor and suffered from methodologic or design weaknesses, the authors note.

To address this gap, Dr. Valls and colleagues randomly assigned 67 individuals with moderate hypercholesterolemia (defined as LDL levels of at least 115 mg/dL) to receive one ABG tablet (250 mg ABG extract/1.25 mg SAC) or placebo daily for 6 weeks. Following a 3-week washout, the groups were reversed and the new intervention continued for another 6 weeks.

Participants received dietary recommendations regarding CVD risk factors and had their dietary habits assessed through a 3-day food record at baseline and after 6 weeks during both treatments.

Individuals receiving lipid-lowering treatment or antihypertensives were excluded, as were those with a body mass index of 35 kg/m² or higher, those with a fasting blood glucose of at least 126 mg/dL, or active smokers.

There were no differences in baseline characteristics between the two groups. The mean systolic and diastolic pressures at baseline were 124/75 mm Hg in the ABG group and 121/74 mm Hg in the placebo group. Their mean age was 53 years.

Adherence with the protocol was “high” at 96.5% in both groups, and no adverse effects were reported.
 

Reduced risk of death from stroke, ischemic heart disease

Although no significant differences between ABG and placebo were observed at 3 weeks, the decline in DBP after consumption of the ABG extract became significant at 6 weeks (mean change, –3.7 mm Hg vs. –0.10 mm Hg; P = .007).

When stratified by sex and categories of DBP, the mean change in DBP after 6 weeks of ABG consumption was particularly prominent in men and in those with a baseline DBP of at least 75 mm Hg.

Small study

Commenting for this news organization, Linda Van Horn, PhD, RDN, professor and chief of the department of preventive medicine’s nutrition division, Northwestern University, Chicago, said that for many years, garlic has been “reported to be an adjunct to the benefits of a healthy eating pattern, with inconclusive results.”

She noted that ABG is “literally aged for many months to years, and the resulting concentrate is found higher in many organosulfur compounds and phytochemicals that suggest enhanced response.”

Dr. Van Horn, a member of the American Heart Association’s Nutrition Committee, who was not involved with the study, continued: “The data suggest that ABG that is much more highly concentrated than fresh or processed garlic might be helpful in lowering BP in certain subgroups, in this case men with higher BP.”

However, she cautioned, “these results are limited in a small study, and ... potential other issues, such as sodium, potassium, or other nutrients known to be associated with blood pressure, were not reported, thereby raising questions about the exclusivity of the ABG over other accompanying dietary factors.”

The study was funded by the Center for the Development of Industrial Technology of the Spanish Ministry of Science and Innovation. Two authors are employees of Pharmactive Biotech Products, SL (Madrid), which manufactured the ABG product, but neither played a role in any result or conclusion. The other authors and Dr. Van Horn report no relevant financial relationships.

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

A new study has found that aged black garlic (ABG) on top of dietary guidance lowers diastolic blood pressure (DBP) in men with moderately elevated cholesterol.

After 6 weeks, consumption of ABG with a high concentration of s-allyl-L-cystine (SAC) was associated with a nearly 6-mm Hg reduction in DBP in men. Other cardiovascular disease (CVD) risk factors were not significantly affected.

“The observed reduction in DBP by ABG extract was similar to the effects of dietary approaches, including the effects of the Dietary Approaches to Stop Hypertension(DASH) diet on BP,” say Rosa M. Valls, PhD, Universitat Rovira i Virgili, Reus, Spain, and colleagues.

“The potential beneficial effects of ABG may contribute to obtaining an optimal DBP” but were “better observed in men and in nonoptimal DBP populations,” they write in the study, published in Nutrients.

Pure SAC and aged garlics have shown healthy effects on multiple targets in in vitro and in vivo tests. However, previous studies in humans have not focused on ABG but rather on other types of aged garlic in patients with some type of CVD risk factor and suffered from methodologic or design weaknesses, the authors note.

To address this gap, Dr. Valls and colleagues randomly assigned 67 individuals with moderate hypercholesterolemia (defined as LDL levels of at least 115 mg/dL) to receive one ABG tablet (250 mg ABG extract/1.25 mg SAC) or placebo daily for 6 weeks. Following a 3-week washout, the groups were reversed and the new intervention continued for another 6 weeks.

Participants received dietary recommendations regarding CVD risk factors and had their dietary habits assessed through a 3-day food record at baseline and after 6 weeks during both treatments.

Individuals receiving lipid-lowering treatment or antihypertensives were excluded, as were those with a body mass index of 35 kg/m² or higher, those with a fasting blood glucose of at least 126 mg/dL, or active smokers.

There were no differences in baseline characteristics between the two groups. The mean systolic and diastolic pressures at baseline were 124/75 mm Hg in the ABG group and 121/74 mm Hg in the placebo group. Their mean age was 53 years.

Adherence with the protocol was “high” at 96.5% in both groups, and no adverse effects were reported.
 

Reduced risk of death from stroke, ischemic heart disease

Although no significant differences between ABG and placebo were observed at 3 weeks, the decline in DBP after consumption of the ABG extract became significant at 6 weeks (mean change, –3.7 mm Hg vs. –0.10 mm Hg; P = .007).

When stratified by sex and categories of DBP, the mean change in DBP after 6 weeks of ABG consumption was particularly prominent in men and in those with a baseline DBP of at least 75 mm Hg.

Small study

Commenting for this news organization, Linda Van Horn, PhD, RDN, professor and chief of the department of preventive medicine’s nutrition division, Northwestern University, Chicago, said that for many years, garlic has been “reported to be an adjunct to the benefits of a healthy eating pattern, with inconclusive results.”

She noted that ABG is “literally aged for many months to years, and the resulting concentrate is found higher in many organosulfur compounds and phytochemicals that suggest enhanced response.”

Dr. Van Horn, a member of the American Heart Association’s Nutrition Committee, who was not involved with the study, continued: “The data suggest that ABG that is much more highly concentrated than fresh or processed garlic might be helpful in lowering BP in certain subgroups, in this case men with higher BP.”

However, she cautioned, “these results are limited in a small study, and ... potential other issues, such as sodium, potassium, or other nutrients known to be associated with blood pressure, were not reported, thereby raising questions about the exclusivity of the ABG over other accompanying dietary factors.”

The study was funded by the Center for the Development of Industrial Technology of the Spanish Ministry of Science and Innovation. Two authors are employees of Pharmactive Biotech Products, SL (Madrid), which manufactured the ABG product, but neither played a role in any result or conclusion. The other authors and Dr. Van Horn report no relevant financial relationships.

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

West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

With New York nurse practitioners recently gaining full practice authority (FPA), half of the country’s NPs now have the ability to provide patients with easier access to care, according to leading national nurse organizations.

New York joins 24 other states, the District of Columbia, and two U.S. territories that have adopted FPA legislation, as reported by the American Association of Nurse Practitioners (AANP). Like other states, New York has been under an emergency order during the pandemic that allowed NPs to practice to their full authority because of staffing shortages. That order was extended multiple times and was expected to expire this month, AANP reports.

“This has been in the making for nurse practitioners in New York since 2014, trying to get full practice authority,” Michelle Jones, RN, MSN, ANP-C, director at large for the New York State Nurses Association, said in an interview.

NPs who were allowed to practice independently during the pandemic campaigned for that provision to become permanent once the emergency order expired, she said. Ms. Jones explained that the FPA law expands the scope of practice and “removes unnecessary barriers,” namely an agreement with doctors to oversee NPs’ actions.

FPA gives NPs the authority to evaluate patients; diagnose, order, and interpret diagnostic tests; and initiate and manage treatments – including prescribing medications – without oversight by a doctor or state medical board, according to AANP.

Before the pandemic, New York NPs had “reduced” practice authority with those who had more than 3,600 hours of experience required to maintain a collaborative practice agreement with doctors and those with less experience maintaining a written agreement. The change gives full practice authority to those with more than 3,600 hours of experience, Stephen A. Ferrara, DNP, FNP-BC, AANP regional director, said in an interview.

Ferrara, who practices in New York, said the state is the largest to change to FPA. He said the state and others that have moved to FPA have determined that there “has been no lapse in quality care” during the emergency order period and that the regulatory barriers kept NPs from providing access to care.

Jones said that the law also will allow NPs to open private practices and serve underserved patients in areas that lack access to health care. “This is a step to improve access to health care and health equity of the New York population.”

It’s been a while since another state passed FPA legislation, Massachusetts in January 2021 and Delaware in August 2021, according to AANP.

Earlier this month, AANP released new data showing a 9% increase in NPs licensed to practice in the United States, rising from 325,000 in May 2021 to 355,000.

The New York legislation “will help New York attract and retain nurse practitioners and provide New Yorkers better access to quality care,” AANP President April Kapu, DNP, APRN, said in a statement.

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

With New York nurse practitioners recently gaining full practice authority (FPA), half of the country’s NPs now have the ability to provide patients with easier access to care, according to leading national nurse organizations.

New York joins 24 other states, the District of Columbia, and two U.S. territories that have adopted FPA legislation, as reported by the American Association of Nurse Practitioners (AANP). Like other states, New York has been under an emergency order during the pandemic that allowed NPs to practice to their full authority because of staffing shortages. That order was extended multiple times and was expected to expire this month, AANP reports.

“This has been in the making for nurse practitioners in New York since 2014, trying to get full practice authority,” Michelle Jones, RN, MSN, ANP-C, director at large for the New York State Nurses Association, said in an interview.

NPs who were allowed to practice independently during the pandemic campaigned for that provision to become permanent once the emergency order expired, she said. Ms. Jones explained that the FPA law expands the scope of practice and “removes unnecessary barriers,” namely an agreement with doctors to oversee NPs’ actions.

FPA gives NPs the authority to evaluate patients; diagnose, order, and interpret diagnostic tests; and initiate and manage treatments – including prescribing medications – without oversight by a doctor or state medical board, according to AANP.

Before the pandemic, New York NPs had “reduced” practice authority with those who had more than 3,600 hours of experience required to maintain a collaborative practice agreement with doctors and those with less experience maintaining a written agreement. The change gives full practice authority to those with more than 3,600 hours of experience, Stephen A. Ferrara, DNP, FNP-BC, AANP regional director, said in an interview.

Ferrara, who practices in New York, said the state is the largest to change to FPA. He said the state and others that have moved to FPA have determined that there “has been no lapse in quality care” during the emergency order period and that the regulatory barriers kept NPs from providing access to care.

Jones said that the law also will allow NPs to open private practices and serve underserved patients in areas that lack access to health care. “This is a step to improve access to health care and health equity of the New York population.”

It’s been a while since another state passed FPA legislation, Massachusetts in January 2021 and Delaware in August 2021, according to AANP.

Earlier this month, AANP released new data showing a 9% increase in NPs licensed to practice in the United States, rising from 325,000 in May 2021 to 355,000.

The New York legislation “will help New York attract and retain nurse practitioners and provide New Yorkers better access to quality care,” AANP President April Kapu, DNP, APRN, said in a statement.

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

With New York nurse practitioners recently gaining full practice authority (FPA), half of the country’s NPs now have the ability to provide patients with easier access to care, according to leading national nurse organizations.

New York joins 24 other states, the District of Columbia, and two U.S. territories that have adopted FPA legislation, as reported by the American Association of Nurse Practitioners (AANP). Like other states, New York has been under an emergency order during the pandemic that allowed NPs to practice to their full authority because of staffing shortages. That order was extended multiple times and was expected to expire this month, AANP reports.

“This has been in the making for nurse practitioners in New York since 2014, trying to get full practice authority,” Michelle Jones, RN, MSN, ANP-C, director at large for the New York State Nurses Association, said in an interview.

NPs who were allowed to practice independently during the pandemic campaigned for that provision to become permanent once the emergency order expired, she said. Ms. Jones explained that the FPA law expands the scope of practice and “removes unnecessary barriers,” namely an agreement with doctors to oversee NPs’ actions.

FPA gives NPs the authority to evaluate patients; diagnose, order, and interpret diagnostic tests; and initiate and manage treatments – including prescribing medications – without oversight by a doctor or state medical board, according to AANP.

Before the pandemic, New York NPs had “reduced” practice authority with those who had more than 3,600 hours of experience required to maintain a collaborative practice agreement with doctors and those with less experience maintaining a written agreement. The change gives full practice authority to those with more than 3,600 hours of experience, Stephen A. Ferrara, DNP, FNP-BC, AANP regional director, said in an interview.

Ferrara, who practices in New York, said the state is the largest to change to FPA. He said the state and others that have moved to FPA have determined that there “has been no lapse in quality care” during the emergency order period and that the regulatory barriers kept NPs from providing access to care.

Jones said that the law also will allow NPs to open private practices and serve underserved patients in areas that lack access to health care. “This is a step to improve access to health care and health equity of the New York population.”

It’s been a while since another state passed FPA legislation, Massachusetts in January 2021 and Delaware in August 2021, according to AANP.

Earlier this month, AANP released new data showing a 9% increase in NPs licensed to practice in the United States, rising from 325,000 in May 2021 to 355,000.

The New York legislation “will help New York attract and retain nurse practitioners and provide New Yorkers better access to quality care,” AANP President April Kapu, DNP, APRN, said in a statement.

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

Klay Noto wants to be the kind of doctor he never had when he began to question his gender identity.

A second-year student at Tulane University in New Orleans, he wants to listen compassionately to patients’ concerns and recognize the hurt when they question who they are. He will be the kind of doctor who knows that a breast exam can be traumatizing if someone has been breast binding or that instructing a patient to take everything off and put on a gown can be triggering for someone with gender dysphoria.

Being in the room for hard conversations is part of why he pursued med school. “There aren’t many LGBT people in medicine and as I started to understand all the dynamics that go into it, I started to see that I could do it and I could be that different kind of doctor,” he told this news organization.

Mr. Noto, who transitioned after college, wants to see more transgender people like himself teaching gender medicine, and for all medical students to be trained in what it means to be transgender and how to give compassionate and comprehensive care to all patients.

Gains have been made in providing curriculum in transgender care that trains medical students in such concepts as how to approach gender identity with sensitivity and how to manage hormone therapy and surgery for transitioning patients who request that, according to those interviewed for this story.

But they agree there’s a long way to go to having widespread medical school integration of the health care needs of about 1.4 million transgender people in the United States.

According to the Association of American Medical Colleges (AAMC) Curriculum Inventory data collected from 131 U.S. medical schools, more than 65% offered some form of transgender-related education in 2018, and more than 80% of those provided such curriculum in required courses.
 

Lack of transgender, nonbinary faculty

Jason Klein, MD, is a pediatric endocrinologist and medical director of the Transgender Youth Health Program at New York (N.Y.) University.

He said in an interview that the number of programs nationally that have gender medicine as a structured part of their curriculum has increased over the last 5-10 years, but that education is not standardized from program to program.

The program at NYU includes lecture-style learning, case presentations, real-world conversations with people in the community, group discussions, and patient care, Dr. Klein said. There are formal lectures as part of adolescent medicine where students learn the differences between gender and sexual identity, and education on medical treatment of transgender and nonbinary adolescents, starting with puberty blockers and moving into affirming hormones.

Doctors also learn to know their limits and decide when to refer patients to a specialist.

“The focus is really about empathic and supportive care,” said Dr. Klein, assistant professor in the department of pediatrics at Hassenfeld Children’s Hospital at NYU Langone Health. “It’s about communication and understanding and the language we use and how to deliver affirming care in a health care setting in general.”

Imagine the potential stressors, he said, of a transgender person entering a typical health care setting. The electronic health record may only have room for the legal name of a person and not the name a person may currently be using. The intake form typically asks patients to check either male or female. The bathrooms give the same two choices. 

“Every physician should know how to speak with, treat, emote with, and empathize with care for the trans and nonbinary individual,” Dr. Klein said.

Dr. Klein noted there is a glaring shortage of trans and nonbinary physicians to lead efforts to expand education on integrating the medical, psychological, and psychosocial care that patients will receive.

Currently, gender medicine is not included on board exams for adolescent medicine or endocrinology, he said.

“Adding formal training in gender medicine to board exams would really help solidify the importance of this arena of medicine,” he noted.
 

First AAMC standards

In 2014, the AAMC released the first standards to guide curricula across medical school and residency to support training doctors to be competent in caring for transgender patients.

The standards include recommending that all doctors be able to communicate with patients related to their gender identity and understand how to deliver high-quality care to transgender and gender-diverse patients within their specialty, Kristen L. Eckstrand, MD, a coauthor of the guidelines, told this news organization.

“Many medical schools have developed their own curricula to meet these standards,” said Dr. Eckstrand, medical director for LGBTQIA+ Health at the University of Pittsburgh Medical Center.

Norma Poll-Hunter, PhD, AAMC’s senior director for workforce diversity, noted that the organization recently released its diversity, equity, and inclusion competencies that guide the medical education of students, residents, and faculty.

Dr. Poll-Hunter told this news organization that AAMC partners with the Building the Next Generation of Academic Physicians LGBT Health Workforce Conference “to support safe spaces for scholarly efforts and mentorship to advance this area of work.”
 

Team approach at Rutgers

Among the medical schools that incorporate comprehensive transgender care into the curriculum is Rutgers University’s Robert Wood Johnson Medical School in New Brunswick, N.J.

Gloria Bachmann, MD, is professor of obstetrics and gynecology at the school and medical director of its partner, the PROUD Gender Center of New Jersey. PROUD stands for “Promoting Respect, Outreach, Understanding, and Dignity,” and the center provides comprehensive care for transgender and nonbinary patients in one location.

Courtesy Rutgers University

Dr. Bachmann said Rutgers takes a team approach with both instructors and learners teaching medical students about transgender care. The teachers are not only professors in traditional classroom lectures, but patient navigators and nurses at the PROUD center, established as part of the medical school in 2020. Students learn from the navigators, for instance, how to help patients through the spectrum of inpatient and outpatient care.

“All of our learners do get to care for individuals who identify as transgender,” said Dr. Bachmann.

Among the improvements in educating students on transgender care over the years, she said, is the emphasis on social determinants of health. In the transgender population, initial questions may include whether the person is able to access care through insurance as laws vary widely on what care and procedures are covered.

As another example, Dr. Bachmann cites: “If they are seen on an emergency basis and are sent home with medication and follow-up, can they afford it?”

Another consideration is whether there is a home to which they can return.

“Many individuals who are transgender may not have a home. Their family may not be accepting of them. Therefore, it’s the social determinants of health as well as their transgender identity that have to be put into the equation of best care,” she said.
 

Giving back to the trans community

Mr. Noto doesn’t know whether he will specialize in gender medicine, but he is committed to serving the transgender community in whatever physician path he chooses.

He said he realizes he is fortunate to have strong family support and good insurance and that he can afford fees, such as the copay to see transgender care specialists. Many in the community do not have those resources and are likely to get care “only if they have to.”

At Tulane, training in transgender care starts during orientation week and continues on different levels, with different options, throughout medical school and residency, he added.

Mr. Noto said he would like to see more mandatory learning such as a “queer-centered exam, where you have to give an organ inventory and you have to ask patients if it’s OK to talk about X, Y, and Z.” He’d also like more opportunities for clinical interaction with transgender patients, such as queer-centered rotations.

When physicians aren’t well trained in transgender care, you have patients educating the doctors, which, Mr. Noto said, should not be acceptable.

“People come to you on their worst day. And to not be informed about them in my mind is negligent. In what other population can you choose not to learn about someone just because you don’t want to?” he said.

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

Klay Noto wants to be the kind of doctor he never had when he began to question his gender identity.

A second-year student at Tulane University in New Orleans, he wants to listen compassionately to patients’ concerns and recognize the hurt when they question who they are. He will be the kind of doctor who knows that a breast exam can be traumatizing if someone has been breast binding or that instructing a patient to take everything off and put on a gown can be triggering for someone with gender dysphoria.

Being in the room for hard conversations is part of why he pursued med school. “There aren’t many LGBT people in medicine and as I started to understand all the dynamics that go into it, I started to see that I could do it and I could be that different kind of doctor,” he told this news organization.

Mr. Noto, who transitioned after college, wants to see more transgender people like himself teaching gender medicine, and for all medical students to be trained in what it means to be transgender and how to give compassionate and comprehensive care to all patients.

Gains have been made in providing curriculum in transgender care that trains medical students in such concepts as how to approach gender identity with sensitivity and how to manage hormone therapy and surgery for transitioning patients who request that, according to those interviewed for this story.

But they agree there’s a long way to go to having widespread medical school integration of the health care needs of about 1.4 million transgender people in the United States.

According to the Association of American Medical Colleges (AAMC) Curriculum Inventory data collected from 131 U.S. medical schools, more than 65% offered some form of transgender-related education in 2018, and more than 80% of those provided such curriculum in required courses.
 

Lack of transgender, nonbinary faculty

Jason Klein, MD, is a pediatric endocrinologist and medical director of the Transgender Youth Health Program at New York (N.Y.) University.

He said in an interview that the number of programs nationally that have gender medicine as a structured part of their curriculum has increased over the last 5-10 years, but that education is not standardized from program to program.

The program at NYU includes lecture-style learning, case presentations, real-world conversations with people in the community, group discussions, and patient care, Dr. Klein said. There are formal lectures as part of adolescent medicine where students learn the differences between gender and sexual identity, and education on medical treatment of transgender and nonbinary adolescents, starting with puberty blockers and moving into affirming hormones.

Doctors also learn to know their limits and decide when to refer patients to a specialist.

“The focus is really about empathic and supportive care,” said Dr. Klein, assistant professor in the department of pediatrics at Hassenfeld Children’s Hospital at NYU Langone Health. “It’s about communication and understanding and the language we use and how to deliver affirming care in a health care setting in general.”

Imagine the potential stressors, he said, of a transgender person entering a typical health care setting. The electronic health record may only have room for the legal name of a person and not the name a person may currently be using. The intake form typically asks patients to check either male or female. The bathrooms give the same two choices. 

“Every physician should know how to speak with, treat, emote with, and empathize with care for the trans and nonbinary individual,” Dr. Klein said.

Dr. Klein noted there is a glaring shortage of trans and nonbinary physicians to lead efforts to expand education on integrating the medical, psychological, and psychosocial care that patients will receive.

Currently, gender medicine is not included on board exams for adolescent medicine or endocrinology, he said.

“Adding formal training in gender medicine to board exams would really help solidify the importance of this arena of medicine,” he noted.
 

First AAMC standards

In 2014, the AAMC released the first standards to guide curricula across medical school and residency to support training doctors to be competent in caring for transgender patients.

The standards include recommending that all doctors be able to communicate with patients related to their gender identity and understand how to deliver high-quality care to transgender and gender-diverse patients within their specialty, Kristen L. Eckstrand, MD, a coauthor of the guidelines, told this news organization.

“Many medical schools have developed their own curricula to meet these standards,” said Dr. Eckstrand, medical director for LGBTQIA+ Health at the University of Pittsburgh Medical Center.

Norma Poll-Hunter, PhD, AAMC’s senior director for workforce diversity, noted that the organization recently released its diversity, equity, and inclusion competencies that guide the medical education of students, residents, and faculty.

Dr. Poll-Hunter told this news organization that AAMC partners with the Building the Next Generation of Academic Physicians LGBT Health Workforce Conference “to support safe spaces for scholarly efforts and mentorship to advance this area of work.”
 

Team approach at Rutgers

Among the medical schools that incorporate comprehensive transgender care into the curriculum is Rutgers University’s Robert Wood Johnson Medical School in New Brunswick, N.J.

Gloria Bachmann, MD, is professor of obstetrics and gynecology at the school and medical director of its partner, the PROUD Gender Center of New Jersey. PROUD stands for “Promoting Respect, Outreach, Understanding, and Dignity,” and the center provides comprehensive care for transgender and nonbinary patients in one location.

Courtesy Rutgers University

Dr. Bachmann said Rutgers takes a team approach with both instructors and learners teaching medical students about transgender care. The teachers are not only professors in traditional classroom lectures, but patient navigators and nurses at the PROUD center, established as part of the medical school in 2020. Students learn from the navigators, for instance, how to help patients through the spectrum of inpatient and outpatient care.

“All of our learners do get to care for individuals who identify as transgender,” said Dr. Bachmann.

Among the improvements in educating students on transgender care over the years, she said, is the emphasis on social determinants of health. In the transgender population, initial questions may include whether the person is able to access care through insurance as laws vary widely on what care and procedures are covered.

As another example, Dr. Bachmann cites: “If they are seen on an emergency basis and are sent home with medication and follow-up, can they afford it?”

Another consideration is whether there is a home to which they can return.

“Many individuals who are transgender may not have a home. Their family may not be accepting of them. Therefore, it’s the social determinants of health as well as their transgender identity that have to be put into the equation of best care,” she said.
 

Giving back to the trans community

Mr. Noto doesn’t know whether he will specialize in gender medicine, but he is committed to serving the transgender community in whatever physician path he chooses.

He said he realizes he is fortunate to have strong family support and good insurance and that he can afford fees, such as the copay to see transgender care specialists. Many in the community do not have those resources and are likely to get care “only if they have to.”

At Tulane, training in transgender care starts during orientation week and continues on different levels, with different options, throughout medical school and residency, he added.

Mr. Noto said he would like to see more mandatory learning such as a “queer-centered exam, where you have to give an organ inventory and you have to ask patients if it’s OK to talk about X, Y, and Z.” He’d also like more opportunities for clinical interaction with transgender patients, such as queer-centered rotations.

When physicians aren’t well trained in transgender care, you have patients educating the doctors, which, Mr. Noto said, should not be acceptable.

“People come to you on their worst day. And to not be informed about them in my mind is negligent. In what other population can you choose not to learn about someone just because you don’t want to?” he said.

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

Klay Noto wants to be the kind of doctor he never had when he began to question his gender identity.

A second-year student at Tulane University in New Orleans, he wants to listen compassionately to patients’ concerns and recognize the hurt when they question who they are. He will be the kind of doctor who knows that a breast exam can be traumatizing if someone has been breast binding or that instructing a patient to take everything off and put on a gown can be triggering for someone with gender dysphoria.

Being in the room for hard conversations is part of why he pursued med school. “There aren’t many LGBT people in medicine and as I started to understand all the dynamics that go into it, I started to see that I could do it and I could be that different kind of doctor,” he told this news organization.

Mr. Noto, who transitioned after college, wants to see more transgender people like himself teaching gender medicine, and for all medical students to be trained in what it means to be transgender and how to give compassionate and comprehensive care to all patients.

Gains have been made in providing curriculum in transgender care that trains medical students in such concepts as how to approach gender identity with sensitivity and how to manage hormone therapy and surgery for transitioning patients who request that, according to those interviewed for this story.

But they agree there’s a long way to go to having widespread medical school integration of the health care needs of about 1.4 million transgender people in the United States.

According to the Association of American Medical Colleges (AAMC) Curriculum Inventory data collected from 131 U.S. medical schools, more than 65% offered some form of transgender-related education in 2018, and more than 80% of those provided such curriculum in required courses.
 

Lack of transgender, nonbinary faculty

Jason Klein, MD, is a pediatric endocrinologist and medical director of the Transgender Youth Health Program at New York (N.Y.) University.

He said in an interview that the number of programs nationally that have gender medicine as a structured part of their curriculum has increased over the last 5-10 years, but that education is not standardized from program to program.

The program at NYU includes lecture-style learning, case presentations, real-world conversations with people in the community, group discussions, and patient care, Dr. Klein said. There are formal lectures as part of adolescent medicine where students learn the differences between gender and sexual identity, and education on medical treatment of transgender and nonbinary adolescents, starting with puberty blockers and moving into affirming hormones.

Doctors also learn to know their limits and decide when to refer patients to a specialist.

“The focus is really about empathic and supportive care,” said Dr. Klein, assistant professor in the department of pediatrics at Hassenfeld Children’s Hospital at NYU Langone Health. “It’s about communication and understanding and the language we use and how to deliver affirming care in a health care setting in general.”

Imagine the potential stressors, he said, of a transgender person entering a typical health care setting. The electronic health record may only have room for the legal name of a person and not the name a person may currently be using. The intake form typically asks patients to check either male or female. The bathrooms give the same two choices. 

“Every physician should know how to speak with, treat, emote with, and empathize with care for the trans and nonbinary individual,” Dr. Klein said.

Dr. Klein noted there is a glaring shortage of trans and nonbinary physicians to lead efforts to expand education on integrating the medical, psychological, and psychosocial care that patients will receive.

Currently, gender medicine is not included on board exams for adolescent medicine or endocrinology, he said.

“Adding formal training in gender medicine to board exams would really help solidify the importance of this arena of medicine,” he noted.
 

First AAMC standards

In 2014, the AAMC released the first standards to guide curricula across medical school and residency to support training doctors to be competent in caring for transgender patients.

The standards include recommending that all doctors be able to communicate with patients related to their gender identity and understand how to deliver high-quality care to transgender and gender-diverse patients within their specialty, Kristen L. Eckstrand, MD, a coauthor of the guidelines, told this news organization.

“Many medical schools have developed their own curricula to meet these standards,” said Dr. Eckstrand, medical director for LGBTQIA+ Health at the University of Pittsburgh Medical Center.

Norma Poll-Hunter, PhD, AAMC’s senior director for workforce diversity, noted that the organization recently released its diversity, equity, and inclusion competencies that guide the medical education of students, residents, and faculty.

Dr. Poll-Hunter told this news organization that AAMC partners with the Building the Next Generation of Academic Physicians LGBT Health Workforce Conference “to support safe spaces for scholarly efforts and mentorship to advance this area of work.”
 

Team approach at Rutgers

Among the medical schools that incorporate comprehensive transgender care into the curriculum is Rutgers University’s Robert Wood Johnson Medical School in New Brunswick, N.J.

Gloria Bachmann, MD, is professor of obstetrics and gynecology at the school and medical director of its partner, the PROUD Gender Center of New Jersey. PROUD stands for “Promoting Respect, Outreach, Understanding, and Dignity,” and the center provides comprehensive care for transgender and nonbinary patients in one location.

Courtesy Rutgers University

Dr. Bachmann said Rutgers takes a team approach with both instructors and learners teaching medical students about transgender care. The teachers are not only professors in traditional classroom lectures, but patient navigators and nurses at the PROUD center, established as part of the medical school in 2020. Students learn from the navigators, for instance, how to help patients through the spectrum of inpatient and outpatient care.

“All of our learners do get to care for individuals who identify as transgender,” said Dr. Bachmann.

Among the improvements in educating students on transgender care over the years, she said, is the emphasis on social determinants of health. In the transgender population, initial questions may include whether the person is able to access care through insurance as laws vary widely on what care and procedures are covered.

As another example, Dr. Bachmann cites: “If they are seen on an emergency basis and are sent home with medication and follow-up, can they afford it?”

Another consideration is whether there is a home to which they can return.

“Many individuals who are transgender may not have a home. Their family may not be accepting of them. Therefore, it’s the social determinants of health as well as their transgender identity that have to be put into the equation of best care,” she said.
 

Giving back to the trans community

Mr. Noto doesn’t know whether he will specialize in gender medicine, but he is committed to serving the transgender community in whatever physician path he chooses.

He said he realizes he is fortunate to have strong family support and good insurance and that he can afford fees, such as the copay to see transgender care specialists. Many in the community do not have those resources and are likely to get care “only if they have to.”

At Tulane, training in transgender care starts during orientation week and continues on different levels, with different options, throughout medical school and residency, he added.

Mr. Noto said he would like to see more mandatory learning such as a “queer-centered exam, where you have to give an organ inventory and you have to ask patients if it’s OK to talk about X, Y, and Z.” He’d also like more opportunities for clinical interaction with transgender patients, such as queer-centered rotations.

When physicians aren’t well trained in transgender care, you have patients educating the doctors, which, Mr. Noto said, should not be acceptable.

“People come to you on their worst day. And to not be informed about them in my mind is negligent. In what other population can you choose not to learn about someone just because you don’t want to?” he said.

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

A network meta-analysis of 42 clinical trials concludes that rosuvastatin, simvastatin, and atorvastatin are the statins most effective at lowering non-high-density-lipoprotein cholesterol (non-HDL-C) in people with diabetes and at risk for cardiovascular disease.

The analysis focused on the efficacy of statin treatment on reducing non-HDL-C, as opposed to reducing low-density-lipoprotein cholesterol (LDL-C), which has traditionally been used as a surrogate to determine cardiovascular disease risk from hypercholesterolemia.

“The National Cholesterol Education Program in the United States recommends that LDL-C values should be used to estimate the risk of cardiovascular disease related to lipoproteins,” lead author Alexander Hodkinson, MD, senior National Institute for Health Research fellow, University of Manchester, England, told this news organization.

“But we believe that non-high-density-lipoprotein cholesterol is more strongly associated with the risk of cardiovascular disease, because non-HDL-C combines all the bad types of cholesterol, which LDL-C misses, so it could be a better tool than LDL-C for assessing CVD risk and effects of treatment. We already knew which of the statins reduce LDL-C, but we wanted to know which ones reduced non-HDL-C; hence the reason for our study,” Dr. Hodkinson said.

The findings were published online  in BMJ.

In April 2021, the National Institute for Health and Care Excellence (NICE) in the United Kingdom updated guidelines for adults with diabetes to recommend that non-HDL-C should replace LDL-C as the primary target for reducing the risk for cardiovascular disease with lipid-lowering treatment.

Currently, NICE is alone in its recommendation. Other international guidelines do not have a non-HDL-C target and use LDL-C reduction instead. These include guidelines from the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA), and the National Lipid Association.

Non–HDL-C is simple to calculate and can easily be done by clinicians by subtracting HDL-C from the total cholesterol level, he added.

This analysis compared the effectiveness of different statins at different intensities in reducing levels of non-HDL-C in 42 randomized controlled trials that included 20,193 adults with diabetes.

Compared with placebo, rosuvastatin, given at moderate- and high-intensity doses, and simvastatin and atorvastatin at high-intensity doses, were the best at lowering levels of non-HDL-C over an average treatment period of 12 weeks.

High-intensity rosuvastatin led to a 2.31 mmol/L reduction in non-HDL-C (95% credible interval, –3.39 to –1.21). Moderate-intensity rosuvastatin led to a 2.27 mmol/L reduction in non-HDL-C (95% credible interval, –3.00 to –1.49).

High-intensity simvastatin led to a 2.26 mmol/L reduction in non-HDL-C (95% credible interval, –2.99 to –1.51).

High-intensity atorvastatin led to a 2.20 mmol/L reduction in non-HDL-C (95% credible interval, –2.69 to –1.70).

Atorvastatin and simvastatin at any intensity and pravastatin at low intensity were also effective in reducing levels of non-HDL-C, the researchers noted.

In 4,670 patients who were at great risk for a major cardiovascular event, atorvastatin at high intensity showed the largest reduction in levels of non-HDL-C (1.98 mmol/L; 95% credible interval, –4.16 to 0.26).

In addition, high-intensity simvastatin and rosuvastatin were the most effective in reducing LDL-C.

High-intensity simvastatin led to a 1.93 mmol/L reduction in LDL-C (95% credible interval, –2.63 to –1.21), and high-intensity rosuvastatin led to a 1.76 mmol/L reduction in LDL-C (95% credible interval, –2.37 to –1.15).

In four studies, significant reductions in nonfatal myocardial infarction were shown for atorvastatin at moderate intensity, compared with placebo (relative risk, 0.57; 95% confidence interval, 0.43-.76). No significant differences were seen for discontinuations, nonfatal stroke, or cardiovascular death.

“We hope our findings will help guide clinicians on statin selection itself, and what types of doses they should be giving patients. These results support using NICE’s new policy guidelines on cholesterol monitoring, using this non-HDL-C measure, which contains all the bad types of cholesterol for patients with diabetes,” Dr. Hodkinson said.

“This study further emphasizes what we have known about the benefit of statin therapy in patients with type 2 diabetes,” Prakash Deedwania, MD, professor of medicine, University of California, San Francisco, told this news organization.

Dr. Deedwania and others have published data on patients with diabetes that showed that treatment with high-intensity atorvastatin was associated with significant reductions in major adverse cardiovascular events.

“Here they use non-HDL cholesterol as a target. The NICE guidelines are the only guidelines looking at non-HDL cholesterol; however, all guidelines suggest an LDL to be less than 70 in all people with diabetes, and for those with recent acute coronary syndromes, the latest evidence suggests the LDL should actually be less than 50,” said Dr. Deedwania, spokesperson for the AHA and ACC.

As far as which measure to use, he believes both are useful. “It’s six of one and half a dozen of the other, in my opinion. The societies have not recommended non-HDL cholesterol and it’s easier to stay with what is readily available for clinicians, and using LDL cholesterol is still okay. The results of this analysis are confirmatory, in that looking at non-HDL cholesterol gives results very similar to what these statins have shown for their effect on LDL cholesterol,” he said.
 

Non-HDL cholesterol a better marker?

For Robert Rosenson, MD, director of metabolism and lipids at Mount Sinai Health System and professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai, New York, non-HDL cholesterol is becoming an important marker of risk for several reasons.

“The focus on LDL cholesterol has been due to the causal relationship of LDL with atherosclerotic cardiovascular disease, but in the last few decades, non-HDL has emerged because more people are overweight, have insulin resistance, and have diabetes,” Dr. Rosenson told this news organization. “In those situations, the LDL cholesterol underrepresents the risk of the LDL particles. With insulin resistance, the particles become more triglycerides and less cholesterol, so on a per-particle basis, you need to get more LDL particles to get to a certain LDL cholesterol concentration.”

Non-HDL cholesterol testing does not require fasting, another advantage of using it to monitor cholesterol, he added.

What is often forgotten is that moderate- to high-intensity statins have very good triglyceride-lowering effects, Dr. Rosenson said.

“This article highlights that, by using higher doses, you get more triglyceride-lowering. Hopefully, this will get practitioners to recognize that non-HDL cholesterol is a better predictor of risk in people with diabetes,” he said.

The study was funded by the National Institute for Health Research. Dr. Hodkinson, Dr. Rosenson, and Dr. Deedwania report no relevant financial relationships.

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

A network meta-analysis of 42 clinical trials concludes that rosuvastatin, simvastatin, and atorvastatin are the statins most effective at lowering non-high-density-lipoprotein cholesterol (non-HDL-C) in people with diabetes and at risk for cardiovascular disease.

The analysis focused on the efficacy of statin treatment on reducing non-HDL-C, as opposed to reducing low-density-lipoprotein cholesterol (LDL-C), which has traditionally been used as a surrogate to determine cardiovascular disease risk from hypercholesterolemia.

“The National Cholesterol Education Program in the United States recommends that LDL-C values should be used to estimate the risk of cardiovascular disease related to lipoproteins,” lead author Alexander Hodkinson, MD, senior National Institute for Health Research fellow, University of Manchester, England, told this news organization.

“But we believe that non-high-density-lipoprotein cholesterol is more strongly associated with the risk of cardiovascular disease, because non-HDL-C combines all the bad types of cholesterol, which LDL-C misses, so it could be a better tool than LDL-C for assessing CVD risk and effects of treatment. We already knew which of the statins reduce LDL-C, but we wanted to know which ones reduced non-HDL-C; hence the reason for our study,” Dr. Hodkinson said.

The findings were published online  in BMJ.

In April 2021, the National Institute for Health and Care Excellence (NICE) in the United Kingdom updated guidelines for adults with diabetes to recommend that non-HDL-C should replace LDL-C as the primary target for reducing the risk for cardiovascular disease with lipid-lowering treatment.

Currently, NICE is alone in its recommendation. Other international guidelines do not have a non-HDL-C target and use LDL-C reduction instead. These include guidelines from the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA), and the National Lipid Association.

Non–HDL-C is simple to calculate and can easily be done by clinicians by subtracting HDL-C from the total cholesterol level, he added.

This analysis compared the effectiveness of different statins at different intensities in reducing levels of non-HDL-C in 42 randomized controlled trials that included 20,193 adults with diabetes.

Compared with placebo, rosuvastatin, given at moderate- and high-intensity doses, and simvastatin and atorvastatin at high-intensity doses, were the best at lowering levels of non-HDL-C over an average treatment period of 12 weeks.

High-intensity rosuvastatin led to a 2.31 mmol/L reduction in non-HDL-C (95% credible interval, –3.39 to –1.21). Moderate-intensity rosuvastatin led to a 2.27 mmol/L reduction in non-HDL-C (95% credible interval, –3.00 to –1.49).

High-intensity simvastatin led to a 2.26 mmol/L reduction in non-HDL-C (95% credible interval, –2.99 to –1.51).

High-intensity atorvastatin led to a 2.20 mmol/L reduction in non-HDL-C (95% credible interval, –2.69 to –1.70).

Atorvastatin and simvastatin at any intensity and pravastatin at low intensity were also effective in reducing levels of non-HDL-C, the researchers noted.

In 4,670 patients who were at great risk for a major cardiovascular event, atorvastatin at high intensity showed the largest reduction in levels of non-HDL-C (1.98 mmol/L; 95% credible interval, –4.16 to 0.26).

In addition, high-intensity simvastatin and rosuvastatin were the most effective in reducing LDL-C.

High-intensity simvastatin led to a 1.93 mmol/L reduction in LDL-C (95% credible interval, –2.63 to –1.21), and high-intensity rosuvastatin led to a 1.76 mmol/L reduction in LDL-C (95% credible interval, –2.37 to –1.15).

In four studies, significant reductions in nonfatal myocardial infarction were shown for atorvastatin at moderate intensity, compared with placebo (relative risk, 0.57; 95% confidence interval, 0.43-.76). No significant differences were seen for discontinuations, nonfatal stroke, or cardiovascular death.

“We hope our findings will help guide clinicians on statin selection itself, and what types of doses they should be giving patients. These results support using NICE’s new policy guidelines on cholesterol monitoring, using this non-HDL-C measure, which contains all the bad types of cholesterol for patients with diabetes,” Dr. Hodkinson said.

“This study further emphasizes what we have known about the benefit of statin therapy in patients with type 2 diabetes,” Prakash Deedwania, MD, professor of medicine, University of California, San Francisco, told this news organization.

Dr. Deedwania and others have published data on patients with diabetes that showed that treatment with high-intensity atorvastatin was associated with significant reductions in major adverse cardiovascular events.

“Here they use non-HDL cholesterol as a target. The NICE guidelines are the only guidelines looking at non-HDL cholesterol; however, all guidelines suggest an LDL to be less than 70 in all people with diabetes, and for those with recent acute coronary syndromes, the latest evidence suggests the LDL should actually be less than 50,” said Dr. Deedwania, spokesperson for the AHA and ACC.

As far as which measure to use, he believes both are useful. “It’s six of one and half a dozen of the other, in my opinion. The societies have not recommended non-HDL cholesterol and it’s easier to stay with what is readily available for clinicians, and using LDL cholesterol is still okay. The results of this analysis are confirmatory, in that looking at non-HDL cholesterol gives results very similar to what these statins have shown for their effect on LDL cholesterol,” he said.
 

Non-HDL cholesterol a better marker?

For Robert Rosenson, MD, director of metabolism and lipids at Mount Sinai Health System and professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai, New York, non-HDL cholesterol is becoming an important marker of risk for several reasons.

“The focus on LDL cholesterol has been due to the causal relationship of LDL with atherosclerotic cardiovascular disease, but in the last few decades, non-HDL has emerged because more people are overweight, have insulin resistance, and have diabetes,” Dr. Rosenson told this news organization. “In those situations, the LDL cholesterol underrepresents the risk of the LDL particles. With insulin resistance, the particles become more triglycerides and less cholesterol, so on a per-particle basis, you need to get more LDL particles to get to a certain LDL cholesterol concentration.”

Non-HDL cholesterol testing does not require fasting, another advantage of using it to monitor cholesterol, he added.

What is often forgotten is that moderate- to high-intensity statins have very good triglyceride-lowering effects, Dr. Rosenson said.

“This article highlights that, by using higher doses, you get more triglyceride-lowering. Hopefully, this will get practitioners to recognize that non-HDL cholesterol is a better predictor of risk in people with diabetes,” he said.

The study was funded by the National Institute for Health Research. Dr. Hodkinson, Dr. Rosenson, and Dr. Deedwania report no relevant financial relationships.

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

A network meta-analysis of 42 clinical trials concludes that rosuvastatin, simvastatin, and atorvastatin are the statins most effective at lowering non-high-density-lipoprotein cholesterol (non-HDL-C) in people with diabetes and at risk for cardiovascular disease.

The analysis focused on the efficacy of statin treatment on reducing non-HDL-C, as opposed to reducing low-density-lipoprotein cholesterol (LDL-C), which has traditionally been used as a surrogate to determine cardiovascular disease risk from hypercholesterolemia.

“The National Cholesterol Education Program in the United States recommends that LDL-C values should be used to estimate the risk of cardiovascular disease related to lipoproteins,” lead author Alexander Hodkinson, MD, senior National Institute for Health Research fellow, University of Manchester, England, told this news organization.

“But we believe that non-high-density-lipoprotein cholesterol is more strongly associated with the risk of cardiovascular disease, because non-HDL-C combines all the bad types of cholesterol, which LDL-C misses, so it could be a better tool than LDL-C for assessing CVD risk and effects of treatment. We already knew which of the statins reduce LDL-C, but we wanted to know which ones reduced non-HDL-C; hence the reason for our study,” Dr. Hodkinson said.

The findings were published online  in BMJ.

In April 2021, the National Institute for Health and Care Excellence (NICE) in the United Kingdom updated guidelines for adults with diabetes to recommend that non-HDL-C should replace LDL-C as the primary target for reducing the risk for cardiovascular disease with lipid-lowering treatment.

Currently, NICE is alone in its recommendation. Other international guidelines do not have a non-HDL-C target and use LDL-C reduction instead. These include guidelines from the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA), and the National Lipid Association.

Non–HDL-C is simple to calculate and can easily be done by clinicians by subtracting HDL-C from the total cholesterol level, he added.

This analysis compared the effectiveness of different statins at different intensities in reducing levels of non-HDL-C in 42 randomized controlled trials that included 20,193 adults with diabetes.

Compared with placebo, rosuvastatin, given at moderate- and high-intensity doses, and simvastatin and atorvastatin at high-intensity doses, were the best at lowering levels of non-HDL-C over an average treatment period of 12 weeks.

High-intensity rosuvastatin led to a 2.31 mmol/L reduction in non-HDL-C (95% credible interval, –3.39 to –1.21). Moderate-intensity rosuvastatin led to a 2.27 mmol/L reduction in non-HDL-C (95% credible interval, –3.00 to –1.49).

High-intensity simvastatin led to a 2.26 mmol/L reduction in non-HDL-C (95% credible interval, –2.99 to –1.51).

High-intensity atorvastatin led to a 2.20 mmol/L reduction in non-HDL-C (95% credible interval, –2.69 to –1.70).

Atorvastatin and simvastatin at any intensity and pravastatin at low intensity were also effective in reducing levels of non-HDL-C, the researchers noted.

In 4,670 patients who were at great risk for a major cardiovascular event, atorvastatin at high intensity showed the largest reduction in levels of non-HDL-C (1.98 mmol/L; 95% credible interval, –4.16 to 0.26).

In addition, high-intensity simvastatin and rosuvastatin were the most effective in reducing LDL-C.

High-intensity simvastatin led to a 1.93 mmol/L reduction in LDL-C (95% credible interval, –2.63 to –1.21), and high-intensity rosuvastatin led to a 1.76 mmol/L reduction in LDL-C (95% credible interval, –2.37 to –1.15).

In four studies, significant reductions in nonfatal myocardial infarction were shown for atorvastatin at moderate intensity, compared with placebo (relative risk, 0.57; 95% confidence interval, 0.43-.76). No significant differences were seen for discontinuations, nonfatal stroke, or cardiovascular death.

“We hope our findings will help guide clinicians on statin selection itself, and what types of doses they should be giving patients. These results support using NICE’s new policy guidelines on cholesterol monitoring, using this non-HDL-C measure, which contains all the bad types of cholesterol for patients with diabetes,” Dr. Hodkinson said.

“This study further emphasizes what we have known about the benefit of statin therapy in patients with type 2 diabetes,” Prakash Deedwania, MD, professor of medicine, University of California, San Francisco, told this news organization.

Dr. Deedwania and others have published data on patients with diabetes that showed that treatment with high-intensity atorvastatin was associated with significant reductions in major adverse cardiovascular events.

“Here they use non-HDL cholesterol as a target. The NICE guidelines are the only guidelines looking at non-HDL cholesterol; however, all guidelines suggest an LDL to be less than 70 in all people with diabetes, and for those with recent acute coronary syndromes, the latest evidence suggests the LDL should actually be less than 50,” said Dr. Deedwania, spokesperson for the AHA and ACC.

As far as which measure to use, he believes both are useful. “It’s six of one and half a dozen of the other, in my opinion. The societies have not recommended non-HDL cholesterol and it’s easier to stay with what is readily available for clinicians, and using LDL cholesterol is still okay. The results of this analysis are confirmatory, in that looking at non-HDL cholesterol gives results very similar to what these statins have shown for their effect on LDL cholesterol,” he said.
 

Non-HDL cholesterol a better marker?

For Robert Rosenson, MD, director of metabolism and lipids at Mount Sinai Health System and professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai, New York, non-HDL cholesterol is becoming an important marker of risk for several reasons.

“The focus on LDL cholesterol has been due to the causal relationship of LDL with atherosclerotic cardiovascular disease, but in the last few decades, non-HDL has emerged because more people are overweight, have insulin resistance, and have diabetes,” Dr. Rosenson told this news organization. “In those situations, the LDL cholesterol underrepresents the risk of the LDL particles. With insulin resistance, the particles become more triglycerides and less cholesterol, so on a per-particle basis, you need to get more LDL particles to get to a certain LDL cholesterol concentration.”

Non-HDL cholesterol testing does not require fasting, another advantage of using it to monitor cholesterol, he added.

What is often forgotten is that moderate- to high-intensity statins have very good triglyceride-lowering effects, Dr. Rosenson said.

“This article highlights that, by using higher doses, you get more triglyceride-lowering. Hopefully, this will get practitioners to recognize that non-HDL cholesterol is a better predictor of risk in people with diabetes,” he said.

The study was funded by the National Institute for Health Research. Dr. Hodkinson, Dr. Rosenson, and Dr. Deedwania report no relevant financial relationships.

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