Ob.Gyn. News

The Food and Drug Administration has approved the oral medication fezolinetant (Veozah) for the treatment of moderate to severe hot flashes in menopausal women, according to an FDA statement. The approved dose is 45 mg once daily.

Fezolinetant, a neurokinin 3 (NK3) receptor antagonist, is the first drug of its kind to earn FDA approval for the vasomotor symptoms associated with menopause, according to the statement. The drug works by binding to the NK3 receptor, which plays a role in regulating body temperature, and blocking its activity. Fezolinetant is not a hormone, and can be taken by women for whom hormones are contraindicated, such as those with a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease, the FDA stated.

The approval was based on data from the SKYLIGHT 2 trial, results of which were presented at the annual meeting of the Endocrine Society, reported by this news organization, and published in the Journal of Clinical Endocrinology and Metabolism.

In the two-phase trial, women were randomized to 30 mg or 45 mg of fezolinetant or a placebo. After 12 weeks, women in placebo groups were rerandomized to fezolinetant for a 40-week safety study.

The study population included women aged 40-65 years, with an average minimum of seven moderate-to-severe hot flashes per day. The study included 120 sites in North America and Europe.

At 12 weeks, both placebo and fezolinetant patients experienced reductions in moderate to severe vasomotor symptoms of approximately 60%, as well as a significant decrease in vasomotor symptom severity.

The FDA statement noted that patients should undergo baseline blood work before starting fezolinetant to test for liver infection or damage, and the prescribing information includes a warning for liver injury; blood work should be repeated at 3, 6, and 9 months after starting the medication, according to the FDA and a press release from the manufacturer Astellas.

The most common side effects associated with fezolinetant include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver values, according to the FDA statement. The FDA granted Astellas Pharma’s application a Priority Review designation. Astellas has priced the drug at $550 for a 30-day supply, significantly higher than the Institute for Clinical and Economic Review’s previously recommended range of $2,000 to $2,500 per year.

Full prescribing information is available here.

The Food and Drug Administration has approved the oral medication fezolinetant (Veozah) for the treatment of moderate to severe hot flashes in menopausal women, according to an FDA statement. The approved dose is 45 mg once daily.

Fezolinetant, a neurokinin 3 (NK3) receptor antagonist, is the first drug of its kind to earn FDA approval for the vasomotor symptoms associated with menopause, according to the statement. The drug works by binding to the NK3 receptor, which plays a role in regulating body temperature, and blocking its activity. Fezolinetant is not a hormone, and can be taken by women for whom hormones are contraindicated, such as those with a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease, the FDA stated.

The approval was based on data from the SKYLIGHT 2 trial, results of which were presented at the annual meeting of the Endocrine Society, reported by this news organization, and published in the Journal of Clinical Endocrinology and Metabolism.

In the two-phase trial, women were randomized to 30 mg or 45 mg of fezolinetant or a placebo. After 12 weeks, women in placebo groups were rerandomized to fezolinetant for a 40-week safety study.

The study population included women aged 40-65 years, with an average minimum of seven moderate-to-severe hot flashes per day. The study included 120 sites in North America and Europe.

At 12 weeks, both placebo and fezolinetant patients experienced reductions in moderate to severe vasomotor symptoms of approximately 60%, as well as a significant decrease in vasomotor symptom severity.

The FDA statement noted that patients should undergo baseline blood work before starting fezolinetant to test for liver infection or damage, and the prescribing information includes a warning for liver injury; blood work should be repeated at 3, 6, and 9 months after starting the medication, according to the FDA and a press release from the manufacturer Astellas.

The most common side effects associated with fezolinetant include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver values, according to the FDA statement. The FDA granted Astellas Pharma’s application a Priority Review designation. Astellas has priced the drug at $550 for a 30-day supply, significantly higher than the Institute for Clinical and Economic Review’s previously recommended range of $2,000 to $2,500 per year.

Full prescribing information is available here.

The Food and Drug Administration has approved the oral medication fezolinetant (Veozah) for the treatment of moderate to severe hot flashes in menopausal women, according to an FDA statement. The approved dose is 45 mg once daily.

Fezolinetant, a neurokinin 3 (NK3) receptor antagonist, is the first drug of its kind to earn FDA approval for the vasomotor symptoms associated with menopause, according to the statement. The drug works by binding to the NK3 receptor, which plays a role in regulating body temperature, and blocking its activity. Fezolinetant is not a hormone, and can be taken by women for whom hormones are contraindicated, such as those with a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease, the FDA stated.

The approval was based on data from the SKYLIGHT 2 trial, results of which were presented at the annual meeting of the Endocrine Society, reported by this news organization, and published in the Journal of Clinical Endocrinology and Metabolism.

In the two-phase trial, women were randomized to 30 mg or 45 mg of fezolinetant or a placebo. After 12 weeks, women in placebo groups were rerandomized to fezolinetant for a 40-week safety study.

The study population included women aged 40-65 years, with an average minimum of seven moderate-to-severe hot flashes per day. The study included 120 sites in North America and Europe.

At 12 weeks, both placebo and fezolinetant patients experienced reductions in moderate to severe vasomotor symptoms of approximately 60%, as well as a significant decrease in vasomotor symptom severity.

The FDA statement noted that patients should undergo baseline blood work before starting fezolinetant to test for liver infection or damage, and the prescribing information includes a warning for liver injury; blood work should be repeated at 3, 6, and 9 months after starting the medication, according to the FDA and a press release from the manufacturer Astellas.

The most common side effects associated with fezolinetant include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver values, according to the FDA statement. The FDA granted Astellas Pharma’s application a Priority Review designation. Astellas has priced the drug at $550 for a 30-day supply, significantly higher than the Institute for Clinical and Economic Review’s previously recommended range of $2,000 to $2,500 per year.

Full prescribing information is available here.

As the number of cases of early-onset colorectal cancer (CRC) diagnosed before age 50 continues to rise, early detection has become increasingly important.

A new study has identified four signs and symptoms that can serve as red flags to facilitate earlier detection of early-onset CRC. The signs and symptoms are abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia.

Two symptoms in particular – rectal bleeding and iron-deficiency anemia – point to the need for timely endoscopy and follow-up, the researchers say.

“Colorectal cancer is not simply a disease affecting older people; we want younger adults to be aware of and act on these potentially very telling signs and symptoms – particularly because people under 50 are considered to be at low risk, and they don’t receive routine colorectal cancer screening,” senior investigator Yin Cao, ScD, with Washington University School of Medicine, St. Louis, said in a news release.

“It’s also crucial to spread awareness among primary care doctors, gastroenterologists, and emergency medicine doctors,” Dr. Cao added. “To date, many early-onset colorectal cancers are detected in emergency rooms, and there often are significant diagnostic delays with this cancer.”

The study was published online  in the Journal of the National Cancer Institute.

Although previous research has identified rectal bleeding, iron-deficiency anemia, and rectal/abdominal pain as symptoms of early-onset CRC, most studies “have aggregated symptoms till the time of diagnosis,” which limits their use for early detection, the authors explain.

In the current study, the researchers analyzed data from more than 5,000 cases of early-onset CRC and from more than 22,000 control patients using the IBM MarketScan commercial database.

Dr. Cao and colleagues found that between 3 months and 2 years before diagnosis, abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia each indicated an increased risk for early-onset CRC.

Among patients with early-onset CRC, 19.3% presented with one or more of the four red flags between 3 months and 2 years prior to the index date; 15.6% had one symptom, and 3.7% had two or more.

After multivariable adjustment, having one symptom almost doubled the risk for early-onset CRC (odds ratio, 1.94); having two symptoms increased risk by more than threefold (OR, 3.59); and having three or more boosted the risk by more than 6.5-fold (OR, 6.52).

Abdominal pain was associated with a 34% higher risk of early-onset CRC (11.6% among case patients vs. 7.7% among controls; OR, 1.34).

Although not as common, rectal bleeding was associated with the highest odds for early-onset CRC (7.2% case patients vs. 1.3% controls; OR, 5.13).

The other predictive signs and symptoms included diarrhea (2.8% case patients vs. 1.4% controls; OR, 1.43) and iron-deficiency anemia (2.3% case patients vs. 0.9% controls; OR, 2.07).

No differences were observed by gender for each sign or symptom.

Among patients with a red-flag symptom who presented between 3 months and 2 years before diagnosis, for those with early-onset CRC, the median diagnostic interval was 8.7 months.

The researchers suggest that clinicians prioritize prompt diagnostic workups for patients younger than 50 who present with rectal bleeding and/or iron-deficiency anemia and that they also keep abdominal pain and diarrhea in mind as early symptoms.

Dr. Cao noted that since most early-onset CRC cases “have been and will continue to be diagnosed after symptom presentation, it is crucial to recognize these red-flag signs and symptoms promptly and conduct a diagnostic workup as soon as possible.

“By doing so, we can diagnose the disease earlier, which in turn can reduce the need for more aggressive treatment and improve patients’ quality of life and survival rates,” said Dr. Cao.

The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

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

As the number of cases of early-onset colorectal cancer (CRC) diagnosed before age 50 continues to rise, early detection has become increasingly important.

A new study has identified four signs and symptoms that can serve as red flags to facilitate earlier detection of early-onset CRC. The signs and symptoms are abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia.

Two symptoms in particular – rectal bleeding and iron-deficiency anemia – point to the need for timely endoscopy and follow-up, the researchers say.

“Colorectal cancer is not simply a disease affecting older people; we want younger adults to be aware of and act on these potentially very telling signs and symptoms – particularly because people under 50 are considered to be at low risk, and they don’t receive routine colorectal cancer screening,” senior investigator Yin Cao, ScD, with Washington University School of Medicine, St. Louis, said in a news release.

“It’s also crucial to spread awareness among primary care doctors, gastroenterologists, and emergency medicine doctors,” Dr. Cao added. “To date, many early-onset colorectal cancers are detected in emergency rooms, and there often are significant diagnostic delays with this cancer.”

The study was published online  in the Journal of the National Cancer Institute.

Although previous research has identified rectal bleeding, iron-deficiency anemia, and rectal/abdominal pain as symptoms of early-onset CRC, most studies “have aggregated symptoms till the time of diagnosis,” which limits their use for early detection, the authors explain.

In the current study, the researchers analyzed data from more than 5,000 cases of early-onset CRC and from more than 22,000 control patients using the IBM MarketScan commercial database.

Dr. Cao and colleagues found that between 3 months and 2 years before diagnosis, abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia each indicated an increased risk for early-onset CRC.

Among patients with early-onset CRC, 19.3% presented with one or more of the four red flags between 3 months and 2 years prior to the index date; 15.6% had one symptom, and 3.7% had two or more.

After multivariable adjustment, having one symptom almost doubled the risk for early-onset CRC (odds ratio, 1.94); having two symptoms increased risk by more than threefold (OR, 3.59); and having three or more boosted the risk by more than 6.5-fold (OR, 6.52).

Abdominal pain was associated with a 34% higher risk of early-onset CRC (11.6% among case patients vs. 7.7% among controls; OR, 1.34).

Although not as common, rectal bleeding was associated with the highest odds for early-onset CRC (7.2% case patients vs. 1.3% controls; OR, 5.13).

The other predictive signs and symptoms included diarrhea (2.8% case patients vs. 1.4% controls; OR, 1.43) and iron-deficiency anemia (2.3% case patients vs. 0.9% controls; OR, 2.07).

No differences were observed by gender for each sign or symptom.

Among patients with a red-flag symptom who presented between 3 months and 2 years before diagnosis, for those with early-onset CRC, the median diagnostic interval was 8.7 months.

The researchers suggest that clinicians prioritize prompt diagnostic workups for patients younger than 50 who present with rectal bleeding and/or iron-deficiency anemia and that they also keep abdominal pain and diarrhea in mind as early symptoms.

Dr. Cao noted that since most early-onset CRC cases “have been and will continue to be diagnosed after symptom presentation, it is crucial to recognize these red-flag signs and symptoms promptly and conduct a diagnostic workup as soon as possible.

“By doing so, we can diagnose the disease earlier, which in turn can reduce the need for more aggressive treatment and improve patients’ quality of life and survival rates,” said Dr. Cao.

The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

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

As the number of cases of early-onset colorectal cancer (CRC) diagnosed before age 50 continues to rise, early detection has become increasingly important.

A new study has identified four signs and symptoms that can serve as red flags to facilitate earlier detection of early-onset CRC. The signs and symptoms are abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia.

Two symptoms in particular – rectal bleeding and iron-deficiency anemia – point to the need for timely endoscopy and follow-up, the researchers say.

“Colorectal cancer is not simply a disease affecting older people; we want younger adults to be aware of and act on these potentially very telling signs and symptoms – particularly because people under 50 are considered to be at low risk, and they don’t receive routine colorectal cancer screening,” senior investigator Yin Cao, ScD, with Washington University School of Medicine, St. Louis, said in a news release.

“It’s also crucial to spread awareness among primary care doctors, gastroenterologists, and emergency medicine doctors,” Dr. Cao added. “To date, many early-onset colorectal cancers are detected in emergency rooms, and there often are significant diagnostic delays with this cancer.”

The study was published online  in the Journal of the National Cancer Institute.

Although previous research has identified rectal bleeding, iron-deficiency anemia, and rectal/abdominal pain as symptoms of early-onset CRC, most studies “have aggregated symptoms till the time of diagnosis,” which limits their use for early detection, the authors explain.

In the current study, the researchers analyzed data from more than 5,000 cases of early-onset CRC and from more than 22,000 control patients using the IBM MarketScan commercial database.

Dr. Cao and colleagues found that between 3 months and 2 years before diagnosis, abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia each indicated an increased risk for early-onset CRC.

Among patients with early-onset CRC, 19.3% presented with one or more of the four red flags between 3 months and 2 years prior to the index date; 15.6% had one symptom, and 3.7% had two or more.

After multivariable adjustment, having one symptom almost doubled the risk for early-onset CRC (odds ratio, 1.94); having two symptoms increased risk by more than threefold (OR, 3.59); and having three or more boosted the risk by more than 6.5-fold (OR, 6.52).

Abdominal pain was associated with a 34% higher risk of early-onset CRC (11.6% among case patients vs. 7.7% among controls; OR, 1.34).

Although not as common, rectal bleeding was associated with the highest odds for early-onset CRC (7.2% case patients vs. 1.3% controls; OR, 5.13).

The other predictive signs and symptoms included diarrhea (2.8% case patients vs. 1.4% controls; OR, 1.43) and iron-deficiency anemia (2.3% case patients vs. 0.9% controls; OR, 2.07).

No differences were observed by gender for each sign or symptom.

Among patients with a red-flag symptom who presented between 3 months and 2 years before diagnosis, for those with early-onset CRC, the median diagnostic interval was 8.7 months.

The researchers suggest that clinicians prioritize prompt diagnostic workups for patients younger than 50 who present with rectal bleeding and/or iron-deficiency anemia and that they also keep abdominal pain and diarrhea in mind as early symptoms.

Dr. Cao noted that since most early-onset CRC cases “have been and will continue to be diagnosed after symptom presentation, it is crucial to recognize these red-flag signs and symptoms promptly and conduct a diagnostic workup as soon as possible.

“By doing so, we can diagnose the disease earlier, which in turn can reduce the need for more aggressive treatment and improve patients’ quality of life and survival rates,” said Dr. Cao.

The study was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

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

In postmenopausal women with hormone receptor–positive breast cancer, overweight and obesity were overall predictors of lower disease-free survival, but body mass index had no apparent association with the effect of extended endocrine therapy on disease-free survival, new data suggest.

Obesity is a well-known risk factor for breast cancer in postmenopausal women and has been associated with adverse prognosis, said Senna W.M. Lammers, MD, of Maastricht (the Netherlands) University during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. In addition, some studies suggest that patients with higher body mass index (BMI) experience reduced benefits from endocrine therapy, she said.

Dr. Lammers and colleagues conducted a study to determine the prognostic and predictive effect of BMI on disease-free survival in postmenopausal women with hormone receptor–positive (HR+) breast cancer who were treated with extended endocrine therapy.

The study population included participants in the randomized, phase III DATA trial, which evaluated the use of 6 years vs. 3 years of anastrozole in postmenopausal women with HR+ breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen therapy.

Patients were categorized based on BMI as having normal weight (18.5-24.9 kg/m²), overweight (25-29.9 kg/m²), or obese (30 kg/m² or higher). The primary outcome was disease-free survival (DFS); the median follow-up period was 13.1 years.

DFS for patients with normal weight, overweight, and obesity was 66.2%, 59.5%, and 52.4%, with a P value of less than .001 for the trend, Dr. Lammers said. “These results were confirmed in multivariable analysis,” she said. Overall, patients with overweight and obesity had a worse DFS when compared with patients with normal weight (hazard ratio, 1.16; P = .10, for patients with overweight and HR, 1.26; P = .03 for patients with obesity).

“Next, we aimed to determine whether the prognostic effect of BMI differed by age,” Dr. Lammers said.

In women younger than 60 years, overweight and obesity were significantly associated with worse DFS (HR, 1.29; P = .05 and HR 1.83, P less than .001, respectively). However, this effect was not observed in women aged 60 years and older.

The researchers also examined the treatment effect of extended anastrozole on adapted DFS by weight, and found no significant differences among patients with normal weight, overweight, and obesity (HR, 1.00; HR, 0.74; and HR, 0.97, respectively), said Dr. Lammers.

In the question and answer session, Dr. Lammers was asked about possible explanations for the difference in DFS by age. Potential explanations include possible survival bias “as only the healthier [patients with obesity] survive to old age,” she said. Other potential explanations are biological, such as the potentially higher levels of bone density in older [patients with obesity], she said.

When asked about additional clinical implications, Dr. Lammers emphasized the importance of maintaining a healthy BMI for breast cancer patients of all ages. Other research areas might involve the use of lifestyle interventions, although these are challenging to implement, she noted.
 

Data draw attention to quality of life and lifestyle factors

The need to “look at drug development with new eyes” is particularly important when reviewing patient-reported outcomes, said Otto Metzger, MD, of the Dana Farber Cancer Institute, Boston, who served as the discussant for the session.

Dr. Metzger brought up the association between age and the effect of BMI on DFS, specifically.

Based on data from multiple studies and meta-analyses, “I do believe that obesity does play a role in prognosis,” he said, but the question is how long will researchers continue to simply record data without acting to add lifestyle interventions while also trying to develop new drugs, he said. Although convincing patients to make lifestyle changes remains a challenge, patients are often more motivated to make such changes after a cancer diagnosis, Dr. Metzger noted.

“I am a firm believer in the use of digital therapeutics in the context of clinical trials,” said Dr. Metzger. Digital technology offers great potential to educate patients on [adverse effects] and also to improve treatment adherence and quality of life, he concluded.

The study was supported by AstraZeneca, and Dr. Lammers disclosed financial relationships with AstraZeneca and Eli Lilly. Dr. Metzger disclosed receiving research funding to his institution from Pfizer, Genentech/Roche, and Sanofi, and serving as an adviser/consultant to AstraZeneca, Merck, Oncoclinicas, Resilience, and Roche.

In postmenopausal women with hormone receptor–positive breast cancer, overweight and obesity were overall predictors of lower disease-free survival, but body mass index had no apparent association with the effect of extended endocrine therapy on disease-free survival, new data suggest.

Obesity is a well-known risk factor for breast cancer in postmenopausal women and has been associated with adverse prognosis, said Senna W.M. Lammers, MD, of Maastricht (the Netherlands) University during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. In addition, some studies suggest that patients with higher body mass index (BMI) experience reduced benefits from endocrine therapy, she said.

Dr. Lammers and colleagues conducted a study to determine the prognostic and predictive effect of BMI on disease-free survival in postmenopausal women with hormone receptor–positive (HR+) breast cancer who were treated with extended endocrine therapy.

The study population included participants in the randomized, phase III DATA trial, which evaluated the use of 6 years vs. 3 years of anastrozole in postmenopausal women with HR+ breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen therapy.

Patients were categorized based on BMI as having normal weight (18.5-24.9 kg/m²), overweight (25-29.9 kg/m²), or obese (30 kg/m² or higher). The primary outcome was disease-free survival (DFS); the median follow-up period was 13.1 years.

DFS for patients with normal weight, overweight, and obesity was 66.2%, 59.5%, and 52.4%, with a P value of less than .001 for the trend, Dr. Lammers said. “These results were confirmed in multivariable analysis,” she said. Overall, patients with overweight and obesity had a worse DFS when compared with patients with normal weight (hazard ratio, 1.16; P = .10, for patients with overweight and HR, 1.26; P = .03 for patients with obesity).

“Next, we aimed to determine whether the prognostic effect of BMI differed by age,” Dr. Lammers said.

In women younger than 60 years, overweight and obesity were significantly associated with worse DFS (HR, 1.29; P = .05 and HR 1.83, P less than .001, respectively). However, this effect was not observed in women aged 60 years and older.

The researchers also examined the treatment effect of extended anastrozole on adapted DFS by weight, and found no significant differences among patients with normal weight, overweight, and obesity (HR, 1.00; HR, 0.74; and HR, 0.97, respectively), said Dr. Lammers.

In the question and answer session, Dr. Lammers was asked about possible explanations for the difference in DFS by age. Potential explanations include possible survival bias “as only the healthier [patients with obesity] survive to old age,” she said. Other potential explanations are biological, such as the potentially higher levels of bone density in older [patients with obesity], she said.

When asked about additional clinical implications, Dr. Lammers emphasized the importance of maintaining a healthy BMI for breast cancer patients of all ages. Other research areas might involve the use of lifestyle interventions, although these are challenging to implement, she noted.
 

Data draw attention to quality of life and lifestyle factors

The need to “look at drug development with new eyes” is particularly important when reviewing patient-reported outcomes, said Otto Metzger, MD, of the Dana Farber Cancer Institute, Boston, who served as the discussant for the session.

Dr. Metzger brought up the association between age and the effect of BMI on DFS, specifically.

Based on data from multiple studies and meta-analyses, “I do believe that obesity does play a role in prognosis,” he said, but the question is how long will researchers continue to simply record data without acting to add lifestyle interventions while also trying to develop new drugs, he said. Although convincing patients to make lifestyle changes remains a challenge, patients are often more motivated to make such changes after a cancer diagnosis, Dr. Metzger noted.

“I am a firm believer in the use of digital therapeutics in the context of clinical trials,” said Dr. Metzger. Digital technology offers great potential to educate patients on [adverse effects] and also to improve treatment adherence and quality of life, he concluded.

The study was supported by AstraZeneca, and Dr. Lammers disclosed financial relationships with AstraZeneca and Eli Lilly. Dr. Metzger disclosed receiving research funding to his institution from Pfizer, Genentech/Roche, and Sanofi, and serving as an adviser/consultant to AstraZeneca, Merck, Oncoclinicas, Resilience, and Roche.

In postmenopausal women with hormone receptor–positive breast cancer, overweight and obesity were overall predictors of lower disease-free survival, but body mass index had no apparent association with the effect of extended endocrine therapy on disease-free survival, new data suggest.

Obesity is a well-known risk factor for breast cancer in postmenopausal women and has been associated with adverse prognosis, said Senna W.M. Lammers, MD, of Maastricht (the Netherlands) University during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. In addition, some studies suggest that patients with higher body mass index (BMI) experience reduced benefits from endocrine therapy, she said.

Dr. Lammers and colleagues conducted a study to determine the prognostic and predictive effect of BMI on disease-free survival in postmenopausal women with hormone receptor–positive (HR+) breast cancer who were treated with extended endocrine therapy.

The study population included participants in the randomized, phase III DATA trial, which evaluated the use of 6 years vs. 3 years of anastrozole in postmenopausal women with HR+ breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen therapy.

Patients were categorized based on BMI as having normal weight (18.5-24.9 kg/m²), overweight (25-29.9 kg/m²), or obese (30 kg/m² or higher). The primary outcome was disease-free survival (DFS); the median follow-up period was 13.1 years.

DFS for patients with normal weight, overweight, and obesity was 66.2%, 59.5%, and 52.4%, with a P value of less than .001 for the trend, Dr. Lammers said. “These results were confirmed in multivariable analysis,” she said. Overall, patients with overweight and obesity had a worse DFS when compared with patients with normal weight (hazard ratio, 1.16; P = .10, for patients with overweight and HR, 1.26; P = .03 for patients with obesity).

“Next, we aimed to determine whether the prognostic effect of BMI differed by age,” Dr. Lammers said.

In women younger than 60 years, overweight and obesity were significantly associated with worse DFS (HR, 1.29; P = .05 and HR 1.83, P less than .001, respectively). However, this effect was not observed in women aged 60 years and older.

The researchers also examined the treatment effect of extended anastrozole on adapted DFS by weight, and found no significant differences among patients with normal weight, overweight, and obesity (HR, 1.00; HR, 0.74; and HR, 0.97, respectively), said Dr. Lammers.

In the question and answer session, Dr. Lammers was asked about possible explanations for the difference in DFS by age. Potential explanations include possible survival bias “as only the healthier [patients with obesity] survive to old age,” she said. Other potential explanations are biological, such as the potentially higher levels of bone density in older [patients with obesity], she said.

When asked about additional clinical implications, Dr. Lammers emphasized the importance of maintaining a healthy BMI for breast cancer patients of all ages. Other research areas might involve the use of lifestyle interventions, although these are challenging to implement, she noted.
 

Data draw attention to quality of life and lifestyle factors

The need to “look at drug development with new eyes” is particularly important when reviewing patient-reported outcomes, said Otto Metzger, MD, of the Dana Farber Cancer Institute, Boston, who served as the discussant for the session.

Dr. Metzger brought up the association between age and the effect of BMI on DFS, specifically.

Based on data from multiple studies and meta-analyses, “I do believe that obesity does play a role in prognosis,” he said, but the question is how long will researchers continue to simply record data without acting to add lifestyle interventions while also trying to develop new drugs, he said. Although convincing patients to make lifestyle changes remains a challenge, patients are often more motivated to make such changes after a cancer diagnosis, Dr. Metzger noted.

“I am a firm believer in the use of digital therapeutics in the context of clinical trials,” said Dr. Metzger. Digital technology offers great potential to educate patients on [adverse effects] and also to improve treatment adherence and quality of life, he concluded.

The study was supported by AstraZeneca, and Dr. Lammers disclosed financial relationships with AstraZeneca and Eli Lilly. Dr. Metzger disclosed receiving research funding to his institution from Pfizer, Genentech/Roche, and Sanofi, and serving as an adviser/consultant to AstraZeneca, Merck, Oncoclinicas, Resilience, and Roche.

Most adults in the United States (70%) are anxious or extremely anxious about keeping themselves or their families safe, with 42% very anxious about gun violence, results of a national mental health poll conducted by the American Psychiatric Association (APA) show.

“There is a lot of worry in the world right now about economic uncertainty, about violence, about how we’re going to come out of this period of time,” APA President Rebecca W. Brendel, MD, JD, said during an APA press briefing announcing the latest poll results.

Brendel said the results are an important reminder and opportunity for psychiatrists to put their finger on the pulse of Americans’ mental health.

“If 70% of people are feeling unsafe, we need to come up with individual and also society-based solutions to help people move forward so that we can see a brighter future and not experience so much anxiety,” she added.

The poll was conducted between April 20 and 22, 2023, among a nationally representative sample of 2,201 adults. The analysis also tracks data from a poll conducted between April 23 and 24, 2022, among a sample of 2,210 adults.

Overall, nearly two in five adults (37%) reported feeling more anxious than they were at this time last year, which is higher than in 2022 (32%) but lower than in 2021 (41%) and 2020 (62%).

About one-third (30%) of adults said they have consulted a mental health care professional, a slight uptick from 2022.

Other issues keeping Americans up at night include keeping their identity safe (68%), their health (66%), paying bills or expenses (65%), climate change (59%), the opioid epidemic (50%) and the impact of emerging technology on day-to-day life (45%).

Half of respondents reported they would be likely to consider a mental health treatment involving cannabis or marijuana, while most said they would be unlikely to consider a treatment involving psychedelics (59%) or ketamine (56%).

Two-thirds (68%) of American adults reported that their children and teenagers have more mental health problems than they did a decade ago.

More than 50% of parents are concerned about their children’s technology use (59%) and mental state (55%), and 31% have encountered difficulty scheduling appointments with mental health professionals for their children.

More than three-quarters (78%) of U.S. adults believe mental health affects physical health and that untreated mental illness has a significant negative effect on families (78%). About two-thirds (64%) believe untreated mental illness harms the economy.

One in three adults (34%) would not vote for a candidate for elected office who has a mental illness – up 7% from 2022.

“The majority of the public understands something we’ve been saying for a long time: Your mental health is about your health,” Saul Levin, MD, MPA, chief executive officer and medical director at the American Psychiatric Association, said in the release.

“It’s contingent upon us as a field to continue to spread that message, and that those who are experiencing mental health concerns aren’t alone and that there are ways to receive help,” Dr. Levin added.
 

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

Most adults in the United States (70%) are anxious or extremely anxious about keeping themselves or their families safe, with 42% very anxious about gun violence, results of a national mental health poll conducted by the American Psychiatric Association (APA) show.

“There is a lot of worry in the world right now about economic uncertainty, about violence, about how we’re going to come out of this period of time,” APA President Rebecca W. Brendel, MD, JD, said during an APA press briefing announcing the latest poll results.

Brendel said the results are an important reminder and opportunity for psychiatrists to put their finger on the pulse of Americans’ mental health.

“If 70% of people are feeling unsafe, we need to come up with individual and also society-based solutions to help people move forward so that we can see a brighter future and not experience so much anxiety,” she added.

The poll was conducted between April 20 and 22, 2023, among a nationally representative sample of 2,201 adults. The analysis also tracks data from a poll conducted between April 23 and 24, 2022, among a sample of 2,210 adults.

Overall, nearly two in five adults (37%) reported feeling more anxious than they were at this time last year, which is higher than in 2022 (32%) but lower than in 2021 (41%) and 2020 (62%).

About one-third (30%) of adults said they have consulted a mental health care professional, a slight uptick from 2022.

Other issues keeping Americans up at night include keeping their identity safe (68%), their health (66%), paying bills or expenses (65%), climate change (59%), the opioid epidemic (50%) and the impact of emerging technology on day-to-day life (45%).

Half of respondents reported they would be likely to consider a mental health treatment involving cannabis or marijuana, while most said they would be unlikely to consider a treatment involving psychedelics (59%) or ketamine (56%).

Two-thirds (68%) of American adults reported that their children and teenagers have more mental health problems than they did a decade ago.

More than 50% of parents are concerned about their children’s technology use (59%) and mental state (55%), and 31% have encountered difficulty scheduling appointments with mental health professionals for their children.

More than three-quarters (78%) of U.S. adults believe mental health affects physical health and that untreated mental illness has a significant negative effect on families (78%). About two-thirds (64%) believe untreated mental illness harms the economy.

One in three adults (34%) would not vote for a candidate for elected office who has a mental illness – up 7% from 2022.

“The majority of the public understands something we’ve been saying for a long time: Your mental health is about your health,” Saul Levin, MD, MPA, chief executive officer and medical director at the American Psychiatric Association, said in the release.

“It’s contingent upon us as a field to continue to spread that message, and that those who are experiencing mental health concerns aren’t alone and that there are ways to receive help,” Dr. Levin added.
 

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

Most adults in the United States (70%) are anxious or extremely anxious about keeping themselves or their families safe, with 42% very anxious about gun violence, results of a national mental health poll conducted by the American Psychiatric Association (APA) show.

“There is a lot of worry in the world right now about economic uncertainty, about violence, about how we’re going to come out of this period of time,” APA President Rebecca W. Brendel, MD, JD, said during an APA press briefing announcing the latest poll results.

Brendel said the results are an important reminder and opportunity for psychiatrists to put their finger on the pulse of Americans’ mental health.

“If 70% of people are feeling unsafe, we need to come up with individual and also society-based solutions to help people move forward so that we can see a brighter future and not experience so much anxiety,” she added.

The poll was conducted between April 20 and 22, 2023, among a nationally representative sample of 2,201 adults. The analysis also tracks data from a poll conducted between April 23 and 24, 2022, among a sample of 2,210 adults.

Overall, nearly two in five adults (37%) reported feeling more anxious than they were at this time last year, which is higher than in 2022 (32%) but lower than in 2021 (41%) and 2020 (62%).

About one-third (30%) of adults said they have consulted a mental health care professional, a slight uptick from 2022.

Other issues keeping Americans up at night include keeping their identity safe (68%), their health (66%), paying bills or expenses (65%), climate change (59%), the opioid epidemic (50%) and the impact of emerging technology on day-to-day life (45%).

Half of respondents reported they would be likely to consider a mental health treatment involving cannabis or marijuana, while most said they would be unlikely to consider a treatment involving psychedelics (59%) or ketamine (56%).

Two-thirds (68%) of American adults reported that their children and teenagers have more mental health problems than they did a decade ago.

More than 50% of parents are concerned about their children’s technology use (59%) and mental state (55%), and 31% have encountered difficulty scheduling appointments with mental health professionals for their children.

More than three-quarters (78%) of U.S. adults believe mental health affects physical health and that untreated mental illness has a significant negative effect on families (78%). About two-thirds (64%) believe untreated mental illness harms the economy.

One in three adults (34%) would not vote for a candidate for elected office who has a mental illness – up 7% from 2022.

“The majority of the public understands something we’ve been saying for a long time: Your mental health is about your health,” Saul Levin, MD, MPA, chief executive officer and medical director at the American Psychiatric Association, said in the release.

“It’s contingent upon us as a field to continue to spread that message, and that those who are experiencing mental health concerns aren’t alone and that there are ways to receive help,” Dr. Levin added.
 

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

Adverse neonatal outcomes occurred in 24.9% of women treated for gestational diabetes at less than 20 weeks’ gestation compared to 30.5% of controls treated later or not at all, based on data from nearly 800 women.

Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.

“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.

In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.

The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.

The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.

Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.

Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.

Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).

No differences in serious adverse events related to either screening or treatment were noted between the groups.
 

Impact on neonatal outcomes merits further study

Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.

“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.

“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.

The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.

The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.

Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
 

Findings support early screening

Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.

“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.

The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.

The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.

“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.

Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.

The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.

Adverse neonatal outcomes occurred in 24.9% of women treated for gestational diabetes at less than 20 weeks’ gestation compared to 30.5% of controls treated later or not at all, based on data from nearly 800 women.

Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.

“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.

In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.

The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.

The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.

Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.

Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.

Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).

No differences in serious adverse events related to either screening or treatment were noted between the groups.
 

Impact on neonatal outcomes merits further study

Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.

“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.

“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.

The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.

The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.

Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
 

Findings support early screening

Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.

“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.

The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.

The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.

“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.

Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.

The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.

Adverse neonatal outcomes occurred in 24.9% of women treated for gestational diabetes at less than 20 weeks’ gestation compared to 30.5% of controls treated later or not at all, based on data from nearly 800 women.

Screening and treatment for gestational diabetes are currently recommended at 24-28 weeks’ gestation, with earlier testing recommended for women at increased risk, but the potential benefits of earlier intervention remain debatable, wrote David Simmons, MD, of Western Sydney University, Campbelltown, Australia, and colleagues.

“Until now, there has been complete equipoise over whether to treat hyperglycemia below that of overt diabetes early in pregnancy,” Dr. Simmons said in an interview. The conflicting questions: “Would early treatment reduce the excess deposition of fat on the baby with all of its sequelae; but would early treatment reduce fuel supply to some babies at a critical time and lead to SGA [small for gestational age]?” Dr. Simmons noted.

In a study published in the New England Journal of Medicine, Dr. Simmons and colleagues randomized 406 women aged 18 years and older with singleton pregnancies to immediate treatment for gestational diabetes. Another 396 women were randomized to a control group for deferred treatment or no treatment, based on results of an oral glucose tolerance test at 24-28 weeks’ gestation. All participants had at least one risk factor for hyperglycemia, and met the World Health Organization criteria for gestational diabetes. Women with preexisting diabetes or contraindicating comorbid medical conditions were excluded.

The study had three primary outcomes. The first was a composite of neonatal outcomes including birth before 37 weeks’ gestation, birth weight of 4,500 g or higher, birth trauma, neonatal respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia.

The final sample included 748 women for adverse neonatal outcomes, 750 for pregnancy-related hypertension, and 492 for neonatal lean body mass. The mean age of the participants was 32 years; approximately one-third were white European and another third were South Asian. Overall baseline demographics were similar between the groups, and the initial oral glucose tolerance tests were performed at a mean of 15.6 weeks’ gestation.

Overall, 24.9% of women in the early treatment group experienced an adverse neonatal event vs. 30.5% of controls, for an adjusted risk difference of –5.6% and adjusted relative risk of 0.82.

Notably, in an exploratory subgroup analysis, respiratory distress occurred in 9.8% of infants born to women in the immediate treatment group vs. 17.0% of infants in the control group. “Neonatal respiratory distress was the main driver of the between-group difference observed for the first primary outcome,” the researchers wrote. A prespecified subgroup analysis suggested that the impact of an earlier intervention on adverse neonatal outcomes might be greater among women with a higher glycemic value and those whose oral glucose tolerance tests occurred at less than 14 weeks’ gestation, they noted. Stillbirths or neonatal deaths were similar and infrequent in both groups.

Pregnancy-related hypertension occurred in 10.6% of the immediate-treatment group and 9.9% of the controls group (adjusted risk difference, 0.7%). For the third outcome, the mean neonatal lean body mass was 2.86 g in the immediate-treatment group and 2.91 g for the controls (adjusted mean difference, −0.04 g).

No differences in serious adverse events related to either screening or treatment were noted between the groups.
 

Impact on neonatal outcomes merits further study

Dr. Simmons said that he was surprised by the study findings. “We thought if there was an effect, it would be small, but it isn’t,” he told this publication.

“If you combine the severe adverse outcomes, the perineal trauma and the reduction in days in NICU/special care unit, this is a significant impact on morbidity and likely on cost,” and researchers are currently examining data for cost-effectiveness, he said.

“We did not expect the likely large impact on reducing respiratory distress and perineal trauma,” he noted. “These findings have not been previously reported, perhaps because they were not looked for.” By contrast, “we thought here might be reductions in lower gestational age and cesarean delivery, but there was not,” he added.

The findings were limited by several factors including the nonstandardized approach to gestational diabetes treatment and the use of third-trimester treatment targets that had not been tested in earlier trimesters, the researchers noted. Other limitations included the focus on women already at high risk for hyperglycemia; therefore, the results might not generalize to women not at risk, they wrote.

The current study represents a beginning of answers, with data suggesting that early treatment for gestational diabetes reduces severe adverse pregnancy outcomes, days in NICU/special care unit, and perineal trauma, likely from the first trimester, said Dr. Simmons. However, the findings must be interpreted with caution, as criteria that are too low “might lead to more small babies,” he said. “We look forward to working with others to translate these findings into practice,” he added.

Much more research is needed to answer the many questions prompted by the current study, including who did and did not have complications, Dr. Simmons told this publication. Other studies are needed to collect data on cost-effectiveness, as well as consumer views, especially “different perspectives from different parts of the globe,” he said. Although there is not enough evidence yet to draw conclusions about the role of continuous glucose monitoring (CGM) in managing gestational diabetes, many studies are underway; “we look forward to the results,” of these studies, Dr. Simmons added.
 

Findings support early screening

Gestational diabetes is one of the most common medical complications of pregnancy, and accounts for more than 80% of diabetes-related diagnoses in pregnancy, said Emily Fay, MD, a maternal-fetal medicine specialist at the University of Washington, Seattle, in an interview.

“Previous studies have found that women with gestational diabetes are at higher risk in their pregnancy, including higher chance of developing preeclampsia, higher chance of cesarean delivery, and higher risks for their baby, including risk of shoulder dystocia, birth trauma, and jaundice, and higher birth weights,” she said. “Fortunately, studies have also shown that treatment of gestational diabetes helps lower these risks,” she noted. Currently, patients undergo routine screening for gestational diabetes between 24 and 28 weeks of pregnancy, but some who have risk factors for gestational diabetes may have screening in the early part of pregnancy, said Dr. Fay.

The current findings were not surprising overall, said Dr. Fay, who was not involved in the study. “The study authors looked at a variety of outcomes including neonatal adverse outcomes, neonatal body weight, and pregnancy-related hypertension,” she said.

The researchers found that patients treated early had a lower rate of adverse neonatal outcomes, which was to be expected, Dr. Fay said. “They did not find a difference in neonatal body weight; this also was not surprising, as the women who were not in the early treatment group still received treatment at the time of diagnosis later in pregnancy, which likely helped normalize the weights,” she explained.

“My takeaway from this study is that we should continue to screen patients with risk factors for gestational diabetes early in pregnancy and treat them at the time of diagnosis,” Dr. Fay told this publication. However, barriers that may exist to early treatment involve access to care, including being able to see a provider early in pregnancy, she said. “The treatment for gestational diabetes includes dietary education with diet changes and checking blood sugars frequently. Access to nutrition education can be limited and access to healthy foods can be expensive and difficult to obtain,” she noted. “Checking blood sugars throughout the day can also be difficult for those who are busy or working and who may not have the ability to take time to do this,” she said. However, “these barriers may be overcome by health care reform that improves patient access to and coverage of pregnancy care, improved access and affordability of healthy foods, and employer flexibility to allow the time and space to check blood sugars if needed,” she added.

Looking ahead, the use of continuous glucose monitors in pregnancy is an expanding area of research, said Dr. Fay. “Patients can quickly view their blood sugar without the use of finger sticks, which may help overcome some of the barriers patients may have with using finger sticks,” she noted. “Continuous glucose monitors have been used for those with type 1 and type 2 diabetes with success, and we need to better understand if these can also be helpful in gestational diabetes,” she said. Dr. Fay and colleagues at the University of Washington are currently conducting an ongoing study to explore the use of CGM in gestational diabetes.

The study was supported by the National Health and Medical Research Council, the Region Örebro Research Committee, the Medical Scientific Fund of the Mayor of Vienna, the South Western Sydney Local Health District Academic Unit, and a Western Sydney University Ainsworth Trust Grant. The researchers had no financial conflicts to disclose. Dr. Fay had no relevant financial conflicts to disclose.

The number of cancer survivors who report functional limitation has more than doubled in 20 years, according to a research letter published in JAMA Oncology.

Vishal Patel, BS, a student at the Dell Medical School at The University of Texas at Austin, and colleagues identified 51,258 cancer survivors from the National Health Interview Survey, representing a weighted population of approximately 178.8 million from 1999 to 2018.

Most survivors were women (60.2%) and were at least 65 years old (55.4%). In 1999, 3.6 million weighted survivors reported functional limitation. In 2018, the number increased to 8.2 million, a 2.25-fold increase.

The number of survivors who reported no limitations also increased, but not by as much. That group grew 1.34-fold during the study period.

For context, “the 70% prevalence of functional limitation among survivors in 2018 is nearly twice that of the general population,” the authors wrote.
 

Patients surveyed on function

Functional limitation was defined as “self-reported difficulty performing any of 12 routine physical or social activities without assistance.” Examples of the activities included difficulty sitting for more than 2 hours, difficulty participating in social activities or difficulty pushing or pulling an object the size of a living room chair.

Over the 2 decades analyzed, the adjusted prevalence of functional limitation was highest among survivors of pancreatic cancer (80.3%) and lung cancer (76.5%). Prevalence was lowest for survivors of melanoma (62.2%), breast (61.8%) and prostate (59.5%) cancers.
 

Not just a result of living longer

Mr. Patel told this publication that one assumption people might make when they read these results is that people are just living longer with cancer and losing functional ability accordingly.

“But, in fact, we found that the youngest [– those less than 65 years–] actually contributed to this trend more than the oldest people, which means it’s not just [happening], because people are getting older,” he said.

Hispanic and Black individuals had disproportionately higher increases in functional limitation; percentage point increases over the 2 decades were 19.5 for Black people, 25.1 for Hispanic people and 12.5 for White people. There may be a couple of reasons for that, Mr. Patel noted.

Those who are Black or Hispanic tend to have less access to cancer survivorship care for reasons including insurance status and historic health care inequities, he noted.

“The other potential reason is that they have had less access to cancer care historically. And if, 20 years ago Black and Hispanic individuals didn’t have access to some chemotherapies, and now they do, maybe it’s the increased access to care that’s causing these functional limitations. Because chemotherapy can sometimes be very toxic. It may be sort of a catch-up toxicity,” he said.
 

Quality of life beyond survivorship

Mr. Patel said the results seem to call for building on improved survival rates by tracking and improving function.

“It’s good to celebrate that there are more survivors. But now that we can keep people alive longer, maybe we can shift gears to improving their quality of life,” he said.

The more-than-doubling of functional limitations over 2 decades “is a very sobering trend,” he noted, while pointing out that the functional limitations applied to 8 million people in the United States – people whose needs are not being met.

There’s no sign of the trend stopping, he continued. “We saw no downward trend, only an upward trend.”

Increasingly, including functionality as an endpoint in cancer trials, in addition to improvements in mortality, is one place to start, he added.

“Our findings suggest an urgent need for care teams to understand and address function, for researchers to evaluate function as a core outcome in trials, and for health systems and policy makers to reimagine survivorship care, recognizing the burden of cancer and its treatment on physical, psychosocial, and cognitive function,” the authors wrote in their paper. Limitations of the study include the potential for recall bias, lack of cancer staging or treatment information, and the subjective perception of function.

A coauthor reported personal fees from Astellas, AstraZeneca, AAA, Blue Earth, Janssen, Lantheus, Myovant, Myriad Genetics, Novartis, Telix, and Sanofi, as well as grants from Pfizer and Bayer during the conduct of the study. No other disclosures were reported.

The number of cancer survivors who report functional limitation has more than doubled in 20 years, according to a research letter published in JAMA Oncology.

Vishal Patel, BS, a student at the Dell Medical School at The University of Texas at Austin, and colleagues identified 51,258 cancer survivors from the National Health Interview Survey, representing a weighted population of approximately 178.8 million from 1999 to 2018.

Most survivors were women (60.2%) and were at least 65 years old (55.4%). In 1999, 3.6 million weighted survivors reported functional limitation. In 2018, the number increased to 8.2 million, a 2.25-fold increase.

The number of survivors who reported no limitations also increased, but not by as much. That group grew 1.34-fold during the study period.

For context, “the 70% prevalence of functional limitation among survivors in 2018 is nearly twice that of the general population,” the authors wrote.
 

Patients surveyed on function

Functional limitation was defined as “self-reported difficulty performing any of 12 routine physical or social activities without assistance.” Examples of the activities included difficulty sitting for more than 2 hours, difficulty participating in social activities or difficulty pushing or pulling an object the size of a living room chair.

Over the 2 decades analyzed, the adjusted prevalence of functional limitation was highest among survivors of pancreatic cancer (80.3%) and lung cancer (76.5%). Prevalence was lowest for survivors of melanoma (62.2%), breast (61.8%) and prostate (59.5%) cancers.
 

Not just a result of living longer

Mr. Patel told this publication that one assumption people might make when they read these results is that people are just living longer with cancer and losing functional ability accordingly.

“But, in fact, we found that the youngest [– those less than 65 years–] actually contributed to this trend more than the oldest people, which means it’s not just [happening], because people are getting older,” he said.

Hispanic and Black individuals had disproportionately higher increases in functional limitation; percentage point increases over the 2 decades were 19.5 for Black people, 25.1 for Hispanic people and 12.5 for White people. There may be a couple of reasons for that, Mr. Patel noted.

Those who are Black or Hispanic tend to have less access to cancer survivorship care for reasons including insurance status and historic health care inequities, he noted.

“The other potential reason is that they have had less access to cancer care historically. And if, 20 years ago Black and Hispanic individuals didn’t have access to some chemotherapies, and now they do, maybe it’s the increased access to care that’s causing these functional limitations. Because chemotherapy can sometimes be very toxic. It may be sort of a catch-up toxicity,” he said.
 

Quality of life beyond survivorship

Mr. Patel said the results seem to call for building on improved survival rates by tracking and improving function.

“It’s good to celebrate that there are more survivors. But now that we can keep people alive longer, maybe we can shift gears to improving their quality of life,” he said.

The more-than-doubling of functional limitations over 2 decades “is a very sobering trend,” he noted, while pointing out that the functional limitations applied to 8 million people in the United States – people whose needs are not being met.

There’s no sign of the trend stopping, he continued. “We saw no downward trend, only an upward trend.”

Increasingly, including functionality as an endpoint in cancer trials, in addition to improvements in mortality, is one place to start, he added.

“Our findings suggest an urgent need for care teams to understand and address function, for researchers to evaluate function as a core outcome in trials, and for health systems and policy makers to reimagine survivorship care, recognizing the burden of cancer and its treatment on physical, psychosocial, and cognitive function,” the authors wrote in their paper. Limitations of the study include the potential for recall bias, lack of cancer staging or treatment information, and the subjective perception of function.

A coauthor reported personal fees from Astellas, AstraZeneca, AAA, Blue Earth, Janssen, Lantheus, Myovant, Myriad Genetics, Novartis, Telix, and Sanofi, as well as grants from Pfizer and Bayer during the conduct of the study. No other disclosures were reported.

The number of cancer survivors who report functional limitation has more than doubled in 20 years, according to a research letter published in JAMA Oncology.

Vishal Patel, BS, a student at the Dell Medical School at The University of Texas at Austin, and colleagues identified 51,258 cancer survivors from the National Health Interview Survey, representing a weighted population of approximately 178.8 million from 1999 to 2018.

Most survivors were women (60.2%) and were at least 65 years old (55.4%). In 1999, 3.6 million weighted survivors reported functional limitation. In 2018, the number increased to 8.2 million, a 2.25-fold increase.

The number of survivors who reported no limitations also increased, but not by as much. That group grew 1.34-fold during the study period.

For context, “the 70% prevalence of functional limitation among survivors in 2018 is nearly twice that of the general population,” the authors wrote.
 

Patients surveyed on function

Functional limitation was defined as “self-reported difficulty performing any of 12 routine physical or social activities without assistance.” Examples of the activities included difficulty sitting for more than 2 hours, difficulty participating in social activities or difficulty pushing or pulling an object the size of a living room chair.

Over the 2 decades analyzed, the adjusted prevalence of functional limitation was highest among survivors of pancreatic cancer (80.3%) and lung cancer (76.5%). Prevalence was lowest for survivors of melanoma (62.2%), breast (61.8%) and prostate (59.5%) cancers.
 

Not just a result of living longer

Mr. Patel told this publication that one assumption people might make when they read these results is that people are just living longer with cancer and losing functional ability accordingly.

“But, in fact, we found that the youngest [– those less than 65 years–] actually contributed to this trend more than the oldest people, which means it’s not just [happening], because people are getting older,” he said.

Hispanic and Black individuals had disproportionately higher increases in functional limitation; percentage point increases over the 2 decades were 19.5 for Black people, 25.1 for Hispanic people and 12.5 for White people. There may be a couple of reasons for that, Mr. Patel noted.

Those who are Black or Hispanic tend to have less access to cancer survivorship care for reasons including insurance status and historic health care inequities, he noted.

“The other potential reason is that they have had less access to cancer care historically. And if, 20 years ago Black and Hispanic individuals didn’t have access to some chemotherapies, and now they do, maybe it’s the increased access to care that’s causing these functional limitations. Because chemotherapy can sometimes be very toxic. It may be sort of a catch-up toxicity,” he said.
 

Quality of life beyond survivorship

Mr. Patel said the results seem to call for building on improved survival rates by tracking and improving function.

“It’s good to celebrate that there are more survivors. But now that we can keep people alive longer, maybe we can shift gears to improving their quality of life,” he said.

The more-than-doubling of functional limitations over 2 decades “is a very sobering trend,” he noted, while pointing out that the functional limitations applied to 8 million people in the United States – people whose needs are not being met.

There’s no sign of the trend stopping, he continued. “We saw no downward trend, only an upward trend.”

Increasingly, including functionality as an endpoint in cancer trials, in addition to improvements in mortality, is one place to start, he added.

“Our findings suggest an urgent need for care teams to understand and address function, for researchers to evaluate function as a core outcome in trials, and for health systems and policy makers to reimagine survivorship care, recognizing the burden of cancer and its treatment on physical, psychosocial, and cognitive function,” the authors wrote in their paper. Limitations of the study include the potential for recall bias, lack of cancer staging or treatment information, and the subjective perception of function.

A coauthor reported personal fees from Astellas, AstraZeneca, AAA, Blue Earth, Janssen, Lantheus, Myovant, Myriad Genetics, Novartis, Telix, and Sanofi, as well as grants from Pfizer and Bayer during the conduct of the study. No other disclosures were reported.

A new Canadian guideline on screening for the primary prevention of fragility fractures recommends risk assessment first, before bone mineral density (BMD) testing, for women aged 65 and older. For younger women and men aged 40 and older, screening is not recommended.

To develop the guideline, a writing group from Canadian Task Force on Preventive Health Care commissioned systematic reviews of studies on the benefits and harms of fragility fracture screenings; the predictive accuracy of current risk-assessment tools; patient acceptability; and benefits of treatment. Treatment harms were analyzed via a rapid overview of reviews.

The guideline, published online in the Canadian Medical Association Journal, is aimed at primary care practitioners for their community-dwelling patients aged 40 and older. The recommendations do not apply to people already taking preventive drugs.

Nondrug treatments were beyond the scope of the current guideline, but guidelines on the prevention of falls and other strategies are planned, Roland Grad, MD, a guideline author and associate professor at McGill University in Montreal, told this news organization.

The new guideline says that women aged 65 and older may be able to avoid fracture through screening and preventive medication. An individual’s fracture risk can be estimated with a new Fragility Fractures Decision Aid, which uses the Canadian FRAX risk-assessment tool.

“A risk assessment–first approach promotes shared decision-making with the patient, based on best medical evidence,” Dr. Grad said.

“To help clinicians, we have created an infographic with visuals to communicate the time spent on BMD vs risk assessment first.”
 

New evidence

“At least three things motivated this new guideline,” Dr. Grad said. “When we started work on this prior to the pandemic, we saw a need for updated guidance on screening to prevent fragility fractures. We were also aware of new evidence from the publication of screening trials in females older than 65.”

To conduct the risk assessment in older women, clinicians are advised to do the following:

• Use the decision aid (which patients can also use on their own).
• Use the 10-year absolute risk of major osteoporotic fracture to facilitate shared decision-making about possible benefits and harms of preventive pharmacotherapy.
• If pharmacotherapy is being considered, request a BMD using DXA of the femoral neck, then reestimate the fracture risk by adding the BMD T-score into the FRAX.

Potential harms associated with various treatments, with varying levels of evidence, include the following: with alendronate and denosumab, nonserious gastrointestinal adverse events; with denosumab, rash, eczema, and infections; with zoledronic acid, nonserious events, such as headache and flulike symptoms; and with alendronate and bisphosphonates, rare but serious harms of atypical femoral fracture and osteonecrosis of the jaw.

“These recommendations emphasize the importance of good clinical practice, where clinicians are alert to changes in physical health and patient well-being,” the authors wrote. “Clinicians should also be aware of the importance of secondary prevention (i.e., after fracture) and manage patients accordingly.”

“This is an important topic,” Dr. Grad said. “Fragility fractures are consequential for individuals and for our publicly funded health care system. We anticipate questions from clinicians about the time needed to screen with the risk assessment–first strategy. Our modeling work suggests time savings with [this] strategy compared to a strategy of BMD testing first. Following our recommendations may lead to a reduction in BMD testing.”

To promote the guideline, the CMAJ has recorded a podcast and will use other strategies to increase awareness, Dr. Grad said. “The Canadian Task Force has a communications strategy that includes outreach to primary care, stakeholder webinars, social media, partnerships, and other tactics. The College of Family Physicians of Canada has endorsed the guideline and will help promote to its members.”
 

Other at-risk groups?

Aliya Khan, MD, FRCPC, FACP, FACE, professor in the divisions of endocrinology and metabolism and geriatrics and director of the fellowship in metabolic bone diseases at McMaster University in Hamilton, Ont., told this news organization she agrees with the strategy of evaluating women aged 65 and older for fracture risk.

“The decision aid is useful, but I would like to see it expanded to other circumstances and situations,” she said.

For example, Dr. Khan would like to see recommendations for younger women and for men of all ages regarding secondary causes of osteoporosis or medications known to have a detrimental effect on bone health. By not addressing these patients, she said, “we may miss patients who would benefit from a fracture risk assessment and potentially treatment to prevent low-trauma fractures.”

A recommendation for younger postmenopausal women was included in the most recent Society of Obstetricians and Gynaecologists Canada guideline, she noted.

Overall, she said, “I believe these recommendations will reduce the excess or inappropriate use of BMD testing and that is welcome.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. The task force members report no relevant financial relationships.

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

A new Canadian guideline on screening for the primary prevention of fragility fractures recommends risk assessment first, before bone mineral density (BMD) testing, for women aged 65 and older. For younger women and men aged 40 and older, screening is not recommended.

To develop the guideline, a writing group from Canadian Task Force on Preventive Health Care commissioned systematic reviews of studies on the benefits and harms of fragility fracture screenings; the predictive accuracy of current risk-assessment tools; patient acceptability; and benefits of treatment. Treatment harms were analyzed via a rapid overview of reviews.

The guideline, published online in the Canadian Medical Association Journal, is aimed at primary care practitioners for their community-dwelling patients aged 40 and older. The recommendations do not apply to people already taking preventive drugs.

Nondrug treatments were beyond the scope of the current guideline, but guidelines on the prevention of falls and other strategies are planned, Roland Grad, MD, a guideline author and associate professor at McGill University in Montreal, told this news organization.

The new guideline says that women aged 65 and older may be able to avoid fracture through screening and preventive medication. An individual’s fracture risk can be estimated with a new Fragility Fractures Decision Aid, which uses the Canadian FRAX risk-assessment tool.

“A risk assessment–first approach promotes shared decision-making with the patient, based on best medical evidence,” Dr. Grad said.

“To help clinicians, we have created an infographic with visuals to communicate the time spent on BMD vs risk assessment first.”
 

New evidence

“At least three things motivated this new guideline,” Dr. Grad said. “When we started work on this prior to the pandemic, we saw a need for updated guidance on screening to prevent fragility fractures. We were also aware of new evidence from the publication of screening trials in females older than 65.”

To conduct the risk assessment in older women, clinicians are advised to do the following:

• Use the decision aid (which patients can also use on their own).
• Use the 10-year absolute risk of major osteoporotic fracture to facilitate shared decision-making about possible benefits and harms of preventive pharmacotherapy.
• If pharmacotherapy is being considered, request a BMD using DXA of the femoral neck, then reestimate the fracture risk by adding the BMD T-score into the FRAX.

Potential harms associated with various treatments, with varying levels of evidence, include the following: with alendronate and denosumab, nonserious gastrointestinal adverse events; with denosumab, rash, eczema, and infections; with zoledronic acid, nonserious events, such as headache and flulike symptoms; and with alendronate and bisphosphonates, rare but serious harms of atypical femoral fracture and osteonecrosis of the jaw.

“These recommendations emphasize the importance of good clinical practice, where clinicians are alert to changes in physical health and patient well-being,” the authors wrote. “Clinicians should also be aware of the importance of secondary prevention (i.e., after fracture) and manage patients accordingly.”

“This is an important topic,” Dr. Grad said. “Fragility fractures are consequential for individuals and for our publicly funded health care system. We anticipate questions from clinicians about the time needed to screen with the risk assessment–first strategy. Our modeling work suggests time savings with [this] strategy compared to a strategy of BMD testing first. Following our recommendations may lead to a reduction in BMD testing.”

To promote the guideline, the CMAJ has recorded a podcast and will use other strategies to increase awareness, Dr. Grad said. “The Canadian Task Force has a communications strategy that includes outreach to primary care, stakeholder webinars, social media, partnerships, and other tactics. The College of Family Physicians of Canada has endorsed the guideline and will help promote to its members.”
 

Other at-risk groups?

Aliya Khan, MD, FRCPC, FACP, FACE, professor in the divisions of endocrinology and metabolism and geriatrics and director of the fellowship in metabolic bone diseases at McMaster University in Hamilton, Ont., told this news organization she agrees with the strategy of evaluating women aged 65 and older for fracture risk.

“The decision aid is useful, but I would like to see it expanded to other circumstances and situations,” she said.

For example, Dr. Khan would like to see recommendations for younger women and for men of all ages regarding secondary causes of osteoporosis or medications known to have a detrimental effect on bone health. By not addressing these patients, she said, “we may miss patients who would benefit from a fracture risk assessment and potentially treatment to prevent low-trauma fractures.”

A recommendation for younger postmenopausal women was included in the most recent Society of Obstetricians and Gynaecologists Canada guideline, she noted.

Overall, she said, “I believe these recommendations will reduce the excess or inappropriate use of BMD testing and that is welcome.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. The task force members report no relevant financial relationships.

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

A new Canadian guideline on screening for the primary prevention of fragility fractures recommends risk assessment first, before bone mineral density (BMD) testing, for women aged 65 and older. For younger women and men aged 40 and older, screening is not recommended.

To develop the guideline, a writing group from Canadian Task Force on Preventive Health Care commissioned systematic reviews of studies on the benefits and harms of fragility fracture screenings; the predictive accuracy of current risk-assessment tools; patient acceptability; and benefits of treatment. Treatment harms were analyzed via a rapid overview of reviews.

The guideline, published online in the Canadian Medical Association Journal, is aimed at primary care practitioners for their community-dwelling patients aged 40 and older. The recommendations do not apply to people already taking preventive drugs.

Nondrug treatments were beyond the scope of the current guideline, but guidelines on the prevention of falls and other strategies are planned, Roland Grad, MD, a guideline author and associate professor at McGill University in Montreal, told this news organization.

The new guideline says that women aged 65 and older may be able to avoid fracture through screening and preventive medication. An individual’s fracture risk can be estimated with a new Fragility Fractures Decision Aid, which uses the Canadian FRAX risk-assessment tool.

“A risk assessment–first approach promotes shared decision-making with the patient, based on best medical evidence,” Dr. Grad said.

“To help clinicians, we have created an infographic with visuals to communicate the time spent on BMD vs risk assessment first.”
 

New evidence

“At least three things motivated this new guideline,” Dr. Grad said. “When we started work on this prior to the pandemic, we saw a need for updated guidance on screening to prevent fragility fractures. We were also aware of new evidence from the publication of screening trials in females older than 65.”

To conduct the risk assessment in older women, clinicians are advised to do the following:

• Use the decision aid (which patients can also use on their own).
• Use the 10-year absolute risk of major osteoporotic fracture to facilitate shared decision-making about possible benefits and harms of preventive pharmacotherapy.
• If pharmacotherapy is being considered, request a BMD using DXA of the femoral neck, then reestimate the fracture risk by adding the BMD T-score into the FRAX.

Potential harms associated with various treatments, with varying levels of evidence, include the following: with alendronate and denosumab, nonserious gastrointestinal adverse events; with denosumab, rash, eczema, and infections; with zoledronic acid, nonserious events, such as headache and flulike symptoms; and with alendronate and bisphosphonates, rare but serious harms of atypical femoral fracture and osteonecrosis of the jaw.

“These recommendations emphasize the importance of good clinical practice, where clinicians are alert to changes in physical health and patient well-being,” the authors wrote. “Clinicians should also be aware of the importance of secondary prevention (i.e., after fracture) and manage patients accordingly.”

“This is an important topic,” Dr. Grad said. “Fragility fractures are consequential for individuals and for our publicly funded health care system. We anticipate questions from clinicians about the time needed to screen with the risk assessment–first strategy. Our modeling work suggests time savings with [this] strategy compared to a strategy of BMD testing first. Following our recommendations may lead to a reduction in BMD testing.”

To promote the guideline, the CMAJ has recorded a podcast and will use other strategies to increase awareness, Dr. Grad said. “The Canadian Task Force has a communications strategy that includes outreach to primary care, stakeholder webinars, social media, partnerships, and other tactics. The College of Family Physicians of Canada has endorsed the guideline and will help promote to its members.”
 

Other at-risk groups?

Aliya Khan, MD, FRCPC, FACP, FACE, professor in the divisions of endocrinology and metabolism and geriatrics and director of the fellowship in metabolic bone diseases at McMaster University in Hamilton, Ont., told this news organization she agrees with the strategy of evaluating women aged 65 and older for fracture risk.

“The decision aid is useful, but I would like to see it expanded to other circumstances and situations,” she said.

For example, Dr. Khan would like to see recommendations for younger women and for men of all ages regarding secondary causes of osteoporosis or medications known to have a detrimental effect on bone health. By not addressing these patients, she said, “we may miss patients who would benefit from a fracture risk assessment and potentially treatment to prevent low-trauma fractures.”

A recommendation for younger postmenopausal women was included in the most recent Society of Obstetricians and Gynaecologists Canada guideline, she noted.

Overall, she said, “I believe these recommendations will reduce the excess or inappropriate use of BMD testing and that is welcome.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. The task force members report no relevant financial relationships.

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

Leaders of medical student groups and legislators in a few states are trying to convince medical schools to end a century-old practice of legacy admissions, which they say offer preferential treatment to applicants based on their association with donors or alumni.

While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.

Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.

Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.

As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy. 

Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.

Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
 

Diversity of medical applicants

Diversity in medical schools  continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.

Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.

Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.

The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
 

Legislation may hasten legacies’ end

In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.

The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.

“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”

Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.

The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.

At schools like Harvard,  whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”

Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.   
 

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

Leaders of medical student groups and legislators in a few states are trying to convince medical schools to end a century-old practice of legacy admissions, which they say offer preferential treatment to applicants based on their association with donors or alumni.

While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.

Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.

Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.

As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy. 

Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.

Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
 

Diversity of medical applicants

Diversity in medical schools  continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.

Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.

Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.

The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
 

Legislation may hasten legacies’ end

In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.

The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.

“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”

Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.

The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.

At schools like Harvard,  whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”

Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.   
 

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

Leaders of medical student groups and legislators in a few states are trying to convince medical schools to end a century-old practice of legacy admissions, which they say offer preferential treatment to applicants based on their association with donors or alumni.

While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.

Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.

Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.

As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy. 

Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.

Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
 

Diversity of medical applicants

Diversity in medical schools  continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.

Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.

Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.

The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
 

Legislation may hasten legacies’ end

In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.

The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.

“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”

Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.

The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.

At schools like Harvard,  whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”

Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.   
 

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

As the cost of malpractice insurance continues to increase in many states, physicians in private practice may want to take advantage of discounts insurers offer to reduce premiums.

Getting a better deal might simply mean taking advantage of incentives and discounts your insurer may already offer. These include claims-free, new-to-practice, and working part-time discounts.

However, if you decide to shop around, keep in mind that discounts are just one factor that can affect your premium price – insurers look at your specialty, location, and claims history.

One of the most common ways physicians can earn discounts is by participating in risk management programs. With this type of program, physicians evaluate elements of their practice and documentation practices and identify areas that might leave them at risk for a lawsuit. While they save money, physician risk management programs also are designed to reduce malpractice claims, which ultimately minimizes the potential for bigger financial losses, insurance experts say.

“It’s a win-win situation when liability insurers and physicians work together to minimize risk, and it’s a win for patients,” said Gary Price, MD, president of The Physicians Foundation.

Doctors in private practice or employed by small hospitals that are not self-insured can qualify for these discounts, said David Zetter, president of Zetter HealthCare Management Consultants.

“I do a lot of work with medical malpractice companies trying to find clients policies. All the carriers are transparent about what physicians have to do to lower their premiums. Physicians can receive the discounts if they follow through and meet the insurer’s requirements,” said Mr. Zetter.

State insurance departments regulate medical malpractice insurance, including the premium credits insurers offer. Most states cap discounts at 25%, but some go as high as 70%, according to The Doctors Company, a national physician-owned medical malpractice insurer.

Insurers typically offer doctors several ways to earn discounts. The size of the discount also can depend on whether a doctor is new to a practice, remains claims free, or takes risk management courses.

In addition to the premium discount, some online risk management classes and webinars are eligible for CME credits.

“The credits can add up and they can be used for recertification or relicensure,” said Susan Boisvert, senior patient safety risk manager at The Doctors Company.

Here are five ways you may qualify for discounts with your insurer.

1. Make use of discounts available to new doctors

Doctors can earn hefty discounts on their premiums when they are no longer interns or residents and start practicing medicine. The Doctors Company usually gives a 50% discount on member premiums the first year they’re in practice and a 25% discount credit in their second year. The discounts end after that.  

Other insurance carriers offer similar discounts to doctors starting to practice medicine. The deepest one is offered in the first year (at least 50%) and a smaller one (20%-25%) the second year, according to medical malpractice brokers.

“The new-to-practice discount is based solely on when the physician left their formal training to begin their practice for the first time; it is not based on claim-free history,” explained Mr. Zetter.

This is a very common discount used by different insurer carriers, said Dr. Price. “New physicians don’t have the same amount of risk of a lawsuit when they’re starting out. It’s unlikely they will have a claim and most liability actions have a 2-year time limit from the date of injury to be filed.”

2. Take advantage of being claims free

If you’ve been claims free for at least a few years, you may be eligible for a large discount.

“Doctors without claims are a better risk. Once a doctor has one claim, they’re likely to have a second, which the research shows,” said Mr. Zetter.

The most common credit The Doctors Company offers is 3 years of being claim free – this earns doctors up to 25%, he said. Mr. Zetter explained that the criteria and size of The Doctors Company credit may depend on the state where physicians practice.

“We allowed insurance carriers that we acquired to continue with their own claim-free discount program such as Florida’s First Professionals Insurance Company we acquired in 2011,” he said.

Doctors with other medical malpractice insurers may also be eligible for a credit up to 25%. In some instances, they may have to be claims free for 5 or 10 years, say insurance experts.

It pays to shop around before purchasing insurance.

3. If you work part time, make sure your premium reflects that

Physicians who see patients part time can receive up to a 75% discount on their medical liability insurance premiums.

The discounts are based on the hours the physician works per week. The fewer hours worked, the larger the discount. This type of discount does not vary by specialty.

According to The Doctors Company, working 10 hours or less per week may entitle doctors to a 75% discount; working 11-20 hours per week may entitle them to a 50% discount, and working 21-30 hours per week may entitle them to a 25% discount. If you are in this situation, it pays to ask your insurer if there is a discount available to you.

4. Look into your professional medical society insurance company

“I would look at your state medical association [or] state specialty society and talk to your colleagues to learn what premiums they’re paying and about any discounts they’re getting,” advised Mr. Zetter.

Some state medical societies have formed their own liability companies and offer lower premiums to their members because “they’re organized and managed by doctors, which makes their premiums more competitive,” Dr. Price said.

Other state medical societies endorse specific insurance carriers and offer their members a 5% discount for enrolling with them.

5. Enroll in a risk management program

Most insurers offer online educational activities designed to improve patient safety and reduce the risk of a lawsuit. Physicians may be eligible for both premium discounts and CME credits.

Medical Liability Mutual Insurance Company, owned by Berkshire Hathaway, operates in New York and offers physicians a premium discount of up to 5%, CME credit, and maintenance of certification credit for successfully completing its risk management program every other year.

ProAssurance members nationwide can earn 5% in premium discounts if they complete a 2-hour video series called “Back to Basics: Loss Prevention and Navigating Everyday Risks: Using Data to Drive Change.”

They can earn one credit for completing each webinar on topics such as “Medication Management: Minimizing Errors and Improving Safety” and “Opioid Prescribing: Keeping Patients Safe.”

MagMutual offers its insured physicians 1 CME credit for completing their specialty’s risk assessment and courses, which may be applied toward their premium discounts.

The Doctors Company offers its members a 5% premium discount if they complete 4 CME credits. One of its most popular courses is “How To Get Rid of a Difficult Patient.”

“Busy residents like the shorter case studies worth one-quarter credit that they can complete in 15 minutes,” said Ms. Boisvert.

“This is a good bargain from the physician’s standpoint and the fact that risk management education is offered online makes it a lot easier than going to a seminar in person,” said Dr. Price.

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

As the cost of malpractice insurance continues to increase in many states, physicians in private practice may want to take advantage of discounts insurers offer to reduce premiums.

Getting a better deal might simply mean taking advantage of incentives and discounts your insurer may already offer. These include claims-free, new-to-practice, and working part-time discounts.

However, if you decide to shop around, keep in mind that discounts are just one factor that can affect your premium price – insurers look at your specialty, location, and claims history.

One of the most common ways physicians can earn discounts is by participating in risk management programs. With this type of program, physicians evaluate elements of their practice and documentation practices and identify areas that might leave them at risk for a lawsuit. While they save money, physician risk management programs also are designed to reduce malpractice claims, which ultimately minimizes the potential for bigger financial losses, insurance experts say.

“It’s a win-win situation when liability insurers and physicians work together to minimize risk, and it’s a win for patients,” said Gary Price, MD, president of The Physicians Foundation.

Doctors in private practice or employed by small hospitals that are not self-insured can qualify for these discounts, said David Zetter, president of Zetter HealthCare Management Consultants.

“I do a lot of work with medical malpractice companies trying to find clients policies. All the carriers are transparent about what physicians have to do to lower their premiums. Physicians can receive the discounts if they follow through and meet the insurer’s requirements,” said Mr. Zetter.

State insurance departments regulate medical malpractice insurance, including the premium credits insurers offer. Most states cap discounts at 25%, but some go as high as 70%, according to The Doctors Company, a national physician-owned medical malpractice insurer.

Insurers typically offer doctors several ways to earn discounts. The size of the discount also can depend on whether a doctor is new to a practice, remains claims free, or takes risk management courses.

In addition to the premium discount, some online risk management classes and webinars are eligible for CME credits.

“The credits can add up and they can be used for recertification or relicensure,” said Susan Boisvert, senior patient safety risk manager at The Doctors Company.

Here are five ways you may qualify for discounts with your insurer.

1. Make use of discounts available to new doctors

Doctors can earn hefty discounts on their premiums when they are no longer interns or residents and start practicing medicine. The Doctors Company usually gives a 50% discount on member premiums the first year they’re in practice and a 25% discount credit in their second year. The discounts end after that.  

Other insurance carriers offer similar discounts to doctors starting to practice medicine. The deepest one is offered in the first year (at least 50%) and a smaller one (20%-25%) the second year, according to medical malpractice brokers.

“The new-to-practice discount is based solely on when the physician left their formal training to begin their practice for the first time; it is not based on claim-free history,” explained Mr. Zetter.

This is a very common discount used by different insurer carriers, said Dr. Price. “New physicians don’t have the same amount of risk of a lawsuit when they’re starting out. It’s unlikely they will have a claim and most liability actions have a 2-year time limit from the date of injury to be filed.”

2. Take advantage of being claims free

If you’ve been claims free for at least a few years, you may be eligible for a large discount.

“Doctors without claims are a better risk. Once a doctor has one claim, they’re likely to have a second, which the research shows,” said Mr. Zetter.

The most common credit The Doctors Company offers is 3 years of being claim free – this earns doctors up to 25%, he said. Mr. Zetter explained that the criteria and size of The Doctors Company credit may depend on the state where physicians practice.

“We allowed insurance carriers that we acquired to continue with their own claim-free discount program such as Florida’s First Professionals Insurance Company we acquired in 2011,” he said.

Doctors with other medical malpractice insurers may also be eligible for a credit up to 25%. In some instances, they may have to be claims free for 5 or 10 years, say insurance experts.

It pays to shop around before purchasing insurance.

3. If you work part time, make sure your premium reflects that

Physicians who see patients part time can receive up to a 75% discount on their medical liability insurance premiums.

The discounts are based on the hours the physician works per week. The fewer hours worked, the larger the discount. This type of discount does not vary by specialty.

According to The Doctors Company, working 10 hours or less per week may entitle doctors to a 75% discount; working 11-20 hours per week may entitle them to a 50% discount, and working 21-30 hours per week may entitle them to a 25% discount. If you are in this situation, it pays to ask your insurer if there is a discount available to you.

4. Look into your professional medical society insurance company

“I would look at your state medical association [or] state specialty society and talk to your colleagues to learn what premiums they’re paying and about any discounts they’re getting,” advised Mr. Zetter.