Use of a combination antihypertensive product containing quarter doses of four different drugs could be an effective strategy to get patients to target blood pressures in one step, a new study suggests. 

The study, QUARTET-USA, showed a reduction in BP of almost 5 mm Hg more than the comparator of one antihypertensive agent at standard dose over the 12-week follow-up period in patients with mild to moderate hypertension.

The QUARTET-USA study was presented at the American Heart Association scientific sessions by Mark Huffman, MD, professor of medicine at Washington University in St. Louis. 

It builds on a previous trial, QUARTET, conducted in Australia, which first showed benefits with this approach.

In the new U.S. study, which was considerably smaller than the Australian trial, the four-drug combination, including candesartan, amlodipine, indapamide, and bisoprolol, led to a –4.8/–4.9 mm Hg greater reduction in BP from baseline to 12 weeks, compared with standard-dose candesartan monotherapy.

Differences in systolic BP were not statistically significant, which is likely because of limited power related to the sample size, Dr. Huffman noted.

Adverse events were more common in the four-drug intervention group, but the rate of discontinuation was higher in the comparator group. No severe adverse events were deemed related to the study drug.

“The direction and magnitude of [the] blood pressure–lowering effect were similar between the previous Australian study and this American study, despite different populations with lower baseline blood pressure in the current study, thus strengthening the case for this new approach,” Dr. Huffman concluded.

“The two studies together show that the approach of using four drugs in quarter doses is more effective in lowering blood pressure than a single standard dose antihypertensive agent and has an acceptable safely profile,” he said in an interview.

He said the four-drug combination could be an effective way of getting patients to target without multiple appointments.

“If you think about how many visits to the doctor’s office it takes to get patients to goal blood pressures, this combination gets patients down to new guideline target levels in one step, whereas in the SPRINT trial it took three or more visits to get down to these levels. And in practice we lose people – they don’t come back,” he said.

Dr. Huffman explained that the rationale for the study was the persistently low hypertension control rate, which demonstrates the need for a new approach.

The previous Australian QUARTET study suggested that ultra–low-dose combination therapy has a favorable balance between blood pressure–lowering effect, tolerability, and adherence.

That study, conducted in 591 patients and reported in 2021, demonstrated a greater BP-lowering effect with a four-drug combination at quarter doses (irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, bisoprolol 2.5 mg) at 12 weeks, compared with irbesartan 150 mg daily. Systolic BP was reduced by more than 6.9 mm Hg and diastolic BP by 5.8 mm Hg than full-dose irbesartan alone, both significant differences.

The current study, QUARTET-USA, aimed to see if a similar strategy could produce comparable results in a U.S. population.

The U.S. study included 62 patients from the Access Community Health Network, Chicago, who were either treatment naive with BPs above 140/90 mm Hg, or already taking antihypertensive monotherapy with BPs above 130/85 mm Hg.

The mean systolic BP at baseline was 138 mm Hg and the mean diastolic pressure was 84 mm Hg.

Study participants were mainly from ethnic minorities (90% Hispanic or Black) and over half were from low-income households (annual household income less than $25,000).

They were randomly assigned to daily administration of a four-drug combination at quarter doses (candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, bisoprolol 2.5 mg) or a full dose of candesartan 8 mg (the comparator arm).

Amlodipine 5 mg daily could be added on to treatment if BP remained above 130/80 mm Hg at 6 weeks. This occurred in 18% of the study group versus 53% of the comparator group.

Results showed that at 12 weeks the adjusted mean change in systolic BP weeks was –4.8 mm Hg (95% CI,–10.7 to 1.2), and the adjusted mean change in diastolic BP was –4.9 mm Hg (95% CI, –8.6 to –1.1) in the four-drug combination group, compared with the comparator arm.

Average BPs at the end of 12-week study period were 121 mm Hg systolic and 73 mm Hg diastolic in the four-drug intervention group, compared with 124 mm Hg systolic and 77 mm Hg diastolic in the comparator group.

Any adverse events that were possibly related to drug therapy occurred in 25% of the intervention group versus 10% of the comparator group. But adverse events leading to discontinuation occurred in 6.3% of the study group versus 26.7% of patients in the comparator arm.

“New approaches are needed to achieve lower blood pressure targets, especially for patients and communities with a high burden of hypertension and hypertension-related diseases. QUARTET-USA was the first trial of a four-drug, ultra–low-dose, blood pressure–lowering combination therapy in the U.S.,” Dr. Huffman said.

“We showed reductions in blood pressure similar in magnitude to those in the Australian study. It is useful to know that the direction of the effect is similar across varied populations. Now that we have that signal of efficacy and tolerability, we can move to actually getting it into the hands of patients and providers,” he added.

Noting that further studies will be required to attain marketing authorization, Dr. Huffman suggested that a pharmaceutical company would need to complete that process.

“These are promising results for companies who may be interested in partnering,” he said.

‘A more efficient approach’ 

LaPrincess C. Brewer, MD, assistant professor of medicine at the Mayo Clinic, Rochester, Minn., and discussant of the study, said the QUARTET-USA study suggests the four-drug, low-dose combination shows promise in lowering BP, compared with the standard dose, and while the reduction in systolic BP was not quite significant, it was clinically meaningful.

“Most U.S. adults with hypertension do not have it under control. This is due to unfavorable social and structural determinants of health which limit adherence to antihypertensive medication,” Dr. Brewer noted.  

From a patient point of view, the multiple visits needed to attain goals are a burden and there is also the issue of clinical inertia and lack of medication intensification by clinicians, she commented. 

“Of patients with uncontrolled hypertension, 40% are taking just one antihypertensive medication, so up-front, low-dose combination therapy is likely a more efficient approach,” she said.

“This study builds the evidence base for the need for tailored interventions that address the social determinants of health and the intentional prioritization of diverse population in clinical trials,” Dr. Brewer concluded.

QUARTET was an investigator-initiated study, Dr. Huffman reported a pending patent for a heart failure polypill. The George Institute for Global Health, Sydney, Australia, where Huffman has a secondary appointment, has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy. Dr. Brewer reported research support from the National Institutes of Health, Centers for Disease Control and Prevention, American Heart Association, and Bristol-Meyers Squibb Foundation.

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

Use of a combination antihypertensive product containing quarter doses of four different drugs could be an effective strategy to get patients to target blood pressures in one step, a new study suggests. 

The study, QUARTET-USA, showed a reduction in BP of almost 5 mm Hg more than the comparator of one antihypertensive agent at standard dose over the 12-week follow-up period in patients with mild to moderate hypertension.

The QUARTET-USA study was presented at the American Heart Association scientific sessions by Mark Huffman, MD, professor of medicine at Washington University in St. Louis. 

It builds on a previous trial, QUARTET, conducted in Australia, which first showed benefits with this approach.

In the new U.S. study, which was considerably smaller than the Australian trial, the four-drug combination, including candesartan, amlodipine, indapamide, and bisoprolol, led to a –4.8/–4.9 mm Hg greater reduction in BP from baseline to 12 weeks, compared with standard-dose candesartan monotherapy.

Differences in systolic BP were not statistically significant, which is likely because of limited power related to the sample size, Dr. Huffman noted.

Adverse events were more common in the four-drug intervention group, but the rate of discontinuation was higher in the comparator group. No severe adverse events were deemed related to the study drug.

“The direction and magnitude of [the] blood pressure–lowering effect were similar between the previous Australian study and this American study, despite different populations with lower baseline blood pressure in the current study, thus strengthening the case for this new approach,” Dr. Huffman concluded.

“The two studies together show that the approach of using four drugs in quarter doses is more effective in lowering blood pressure than a single standard dose antihypertensive agent and has an acceptable safely profile,” he said in an interview.

He said the four-drug combination could be an effective way of getting patients to target without multiple appointments.

“If you think about how many visits to the doctor’s office it takes to get patients to goal blood pressures, this combination gets patients down to new guideline target levels in one step, whereas in the SPRINT trial it took three or more visits to get down to these levels. And in practice we lose people – they don’t come back,” he said.

Dr. Huffman explained that the rationale for the study was the persistently low hypertension control rate, which demonstrates the need for a new approach.

The previous Australian QUARTET study suggested that ultra–low-dose combination therapy has a favorable balance between blood pressure–lowering effect, tolerability, and adherence.

That study, conducted in 591 patients and reported in 2021, demonstrated a greater BP-lowering effect with a four-drug combination at quarter doses (irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, bisoprolol 2.5 mg) at 12 weeks, compared with irbesartan 150 mg daily. Systolic BP was reduced by more than 6.9 mm Hg and diastolic BP by 5.8 mm Hg than full-dose irbesartan alone, both significant differences.

The current study, QUARTET-USA, aimed to see if a similar strategy could produce comparable results in a U.S. population.

The U.S. study included 62 patients from the Access Community Health Network, Chicago, who were either treatment naive with BPs above 140/90 mm Hg, or already taking antihypertensive monotherapy with BPs above 130/85 mm Hg.

The mean systolic BP at baseline was 138 mm Hg and the mean diastolic pressure was 84 mm Hg.

Study participants were mainly from ethnic minorities (90% Hispanic or Black) and over half were from low-income households (annual household income less than $25,000).

They were randomly assigned to daily administration of a four-drug combination at quarter doses (candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, bisoprolol 2.5 mg) or a full dose of candesartan 8 mg (the comparator arm).

Amlodipine 5 mg daily could be added on to treatment if BP remained above 130/80 mm Hg at 6 weeks. This occurred in 18% of the study group versus 53% of the comparator group.

Results showed that at 12 weeks the adjusted mean change in systolic BP weeks was –4.8 mm Hg (95% CI,–10.7 to 1.2), and the adjusted mean change in diastolic BP was –4.9 mm Hg (95% CI, –8.6 to –1.1) in the four-drug combination group, compared with the comparator arm.

Average BPs at the end of 12-week study period were 121 mm Hg systolic and 73 mm Hg diastolic in the four-drug intervention group, compared with 124 mm Hg systolic and 77 mm Hg diastolic in the comparator group.

Any adverse events that were possibly related to drug therapy occurred in 25% of the intervention group versus 10% of the comparator group. But adverse events leading to discontinuation occurred in 6.3% of the study group versus 26.7% of patients in the comparator arm.

“New approaches are needed to achieve lower blood pressure targets, especially for patients and communities with a high burden of hypertension and hypertension-related diseases. QUARTET-USA was the first trial of a four-drug, ultra–low-dose, blood pressure–lowering combination therapy in the U.S.,” Dr. Huffman said.

“We showed reductions in blood pressure similar in magnitude to those in the Australian study. It is useful to know that the direction of the effect is similar across varied populations. Now that we have that signal of efficacy and tolerability, we can move to actually getting it into the hands of patients and providers,” he added.

Noting that further studies will be required to attain marketing authorization, Dr. Huffman suggested that a pharmaceutical company would need to complete that process.

“These are promising results for companies who may be interested in partnering,” he said.

‘A more efficient approach’ 

LaPrincess C. Brewer, MD, assistant professor of medicine at the Mayo Clinic, Rochester, Minn., and discussant of the study, said the QUARTET-USA study suggests the four-drug, low-dose combination shows promise in lowering BP, compared with the standard dose, and while the reduction in systolic BP was not quite significant, it was clinically meaningful.

“Most U.S. adults with hypertension do not have it under control. This is due to unfavorable social and structural determinants of health which limit adherence to antihypertensive medication,” Dr. Brewer noted.  

From a patient point of view, the multiple visits needed to attain goals are a burden and there is also the issue of clinical inertia and lack of medication intensification by clinicians, she commented. 

“Of patients with uncontrolled hypertension, 40% are taking just one antihypertensive medication, so up-front, low-dose combination therapy is likely a more efficient approach,” she said.

“This study builds the evidence base for the need for tailored interventions that address the social determinants of health and the intentional prioritization of diverse population in clinical trials,” Dr. Brewer concluded.

QUARTET was an investigator-initiated study, Dr. Huffman reported a pending patent for a heart failure polypill. The George Institute for Global Health, Sydney, Australia, where Huffman has a secondary appointment, has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy. Dr. Brewer reported research support from the National Institutes of Health, Centers for Disease Control and Prevention, American Heart Association, and Bristol-Meyers Squibb Foundation.

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

Use of a combination antihypertensive product containing quarter doses of four different drugs could be an effective strategy to get patients to target blood pressures in one step, a new study suggests. 

The study, QUARTET-USA, showed a reduction in BP of almost 5 mm Hg more than the comparator of one antihypertensive agent at standard dose over the 12-week follow-up period in patients with mild to moderate hypertension.

The QUARTET-USA study was presented at the American Heart Association scientific sessions by Mark Huffman, MD, professor of medicine at Washington University in St. Louis. 

It builds on a previous trial, QUARTET, conducted in Australia, which first showed benefits with this approach.

In the new U.S. study, which was considerably smaller than the Australian trial, the four-drug combination, including candesartan, amlodipine, indapamide, and bisoprolol, led to a –4.8/–4.9 mm Hg greater reduction in BP from baseline to 12 weeks, compared with standard-dose candesartan monotherapy.

Differences in systolic BP were not statistically significant, which is likely because of limited power related to the sample size, Dr. Huffman noted.

Adverse events were more common in the four-drug intervention group, but the rate of discontinuation was higher in the comparator group. No severe adverse events were deemed related to the study drug.

“The direction and magnitude of [the] blood pressure–lowering effect were similar between the previous Australian study and this American study, despite different populations with lower baseline blood pressure in the current study, thus strengthening the case for this new approach,” Dr. Huffman concluded.

“The two studies together show that the approach of using four drugs in quarter doses is more effective in lowering blood pressure than a single standard dose antihypertensive agent and has an acceptable safely profile,” he said in an interview.

He said the four-drug combination could be an effective way of getting patients to target without multiple appointments.

“If you think about how many visits to the doctor’s office it takes to get patients to goal blood pressures, this combination gets patients down to new guideline target levels in one step, whereas in the SPRINT trial it took three or more visits to get down to these levels. And in practice we lose people – they don’t come back,” he said.

Dr. Huffman explained that the rationale for the study was the persistently low hypertension control rate, which demonstrates the need for a new approach.

The previous Australian QUARTET study suggested that ultra–low-dose combination therapy has a favorable balance between blood pressure–lowering effect, tolerability, and adherence.

That study, conducted in 591 patients and reported in 2021, demonstrated a greater BP-lowering effect with a four-drug combination at quarter doses (irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, bisoprolol 2.5 mg) at 12 weeks, compared with irbesartan 150 mg daily. Systolic BP was reduced by more than 6.9 mm Hg and diastolic BP by 5.8 mm Hg than full-dose irbesartan alone, both significant differences.

The current study, QUARTET-USA, aimed to see if a similar strategy could produce comparable results in a U.S. population.

The U.S. study included 62 patients from the Access Community Health Network, Chicago, who were either treatment naive with BPs above 140/90 mm Hg, or already taking antihypertensive monotherapy with BPs above 130/85 mm Hg.

The mean systolic BP at baseline was 138 mm Hg and the mean diastolic pressure was 84 mm Hg.

Study participants were mainly from ethnic minorities (90% Hispanic or Black) and over half were from low-income households (annual household income less than $25,000).

They were randomly assigned to daily administration of a four-drug combination at quarter doses (candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, bisoprolol 2.5 mg) or a full dose of candesartan 8 mg (the comparator arm).

Amlodipine 5 mg daily could be added on to treatment if BP remained above 130/80 mm Hg at 6 weeks. This occurred in 18% of the study group versus 53% of the comparator group.

Results showed that at 12 weeks the adjusted mean change in systolic BP weeks was –4.8 mm Hg (95% CI,–10.7 to 1.2), and the adjusted mean change in diastolic BP was –4.9 mm Hg (95% CI, –8.6 to –1.1) in the four-drug combination group, compared with the comparator arm.

Average BPs at the end of 12-week study period were 121 mm Hg systolic and 73 mm Hg diastolic in the four-drug intervention group, compared with 124 mm Hg systolic and 77 mm Hg diastolic in the comparator group.

Any adverse events that were possibly related to drug therapy occurred in 25% of the intervention group versus 10% of the comparator group. But adverse events leading to discontinuation occurred in 6.3% of the study group versus 26.7% of patients in the comparator arm.

“New approaches are needed to achieve lower blood pressure targets, especially for patients and communities with a high burden of hypertension and hypertension-related diseases. QUARTET-USA was the first trial of a four-drug, ultra–low-dose, blood pressure–lowering combination therapy in the U.S.,” Dr. Huffman said.

“We showed reductions in blood pressure similar in magnitude to those in the Australian study. It is useful to know that the direction of the effect is similar across varied populations. Now that we have that signal of efficacy and tolerability, we can move to actually getting it into the hands of patients and providers,” he added.

Noting that further studies will be required to attain marketing authorization, Dr. Huffman suggested that a pharmaceutical company would need to complete that process.

“These are promising results for companies who may be interested in partnering,” he said.

‘A more efficient approach’ 

LaPrincess C. Brewer, MD, assistant professor of medicine at the Mayo Clinic, Rochester, Minn., and discussant of the study, said the QUARTET-USA study suggests the four-drug, low-dose combination shows promise in lowering BP, compared with the standard dose, and while the reduction in systolic BP was not quite significant, it was clinically meaningful.

“Most U.S. adults with hypertension do not have it under control. This is due to unfavorable social and structural determinants of health which limit adherence to antihypertensive medication,” Dr. Brewer noted.  

From a patient point of view, the multiple visits needed to attain goals are a burden and there is also the issue of clinical inertia and lack of medication intensification by clinicians, she commented. 

“Of patients with uncontrolled hypertension, 40% are taking just one antihypertensive medication, so up-front, low-dose combination therapy is likely a more efficient approach,” she said.

“This study builds the evidence base for the need for tailored interventions that address the social determinants of health and the intentional prioritization of diverse population in clinical trials,” Dr. Brewer concluded.

QUARTET was an investigator-initiated study, Dr. Huffman reported a pending patent for a heart failure polypill. The George Institute for Global Health, Sydney, Australia, where Huffman has a secondary appointment, has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy. Dr. Brewer reported research support from the National Institutes of Health, Centers for Disease Control and Prevention, American Heart Association, and Bristol-Meyers Squibb Foundation.

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

This year Medscape surveyed more than 2,300 physicians about how they prioritized various social issues. Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.

Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
 

Relevance of climate change to health care

In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.

What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”

However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.

And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
 

Domestic violence: What physicians can do

About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.

Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”

Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
 

Expanding legal immigration

In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.

“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.

A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.

A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
 

Reproductive rights: No easy answers

Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.

At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.

While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”

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

This year Medscape surveyed more than 2,300 physicians about how they prioritized various social issues. Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.

Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
 

Relevance of climate change to health care

In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.

What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”

However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.

And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
 

Domestic violence: What physicians can do

About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.

Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”

Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
 

Expanding legal immigration

In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.

“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.

A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.

A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
 

Reproductive rights: No easy answers

Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.

At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.

While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”

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

This year Medscape surveyed more than 2,300 physicians about how they prioritized various social issues. Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.

Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
 

Relevance of climate change to health care

In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.

What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”

However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.

And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
 

Domestic violence: What physicians can do

About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.

Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”

Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
 

Expanding legal immigration

In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.

“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.

A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.

A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
 

Reproductive rights: No easy answers

Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.

At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.

While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”

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

Exercise tops the list of 28 recommendations in a guideline for integrative interventions in patients with rheumatoid arthritis developed by the American College of Rheumatology.

The guideline is specific to RA and presents integrative interventions to accompany treatment with disease-modifying antirheumatic drugs (DMARDs), according to a summary statement issued by the ACR. The summary was approved by the ACR Board of Directors on Oct. 31, and the recommendations are part of a manuscript that will be submitted for publication in both Arthritis & Rheumatology and Arthritis Care & Research.

Consistent engagement in exercise earned the only strong recommendation; the other 27 were conditional. In the exercise category, the authors offered conditional recommendations for aerobic exercise, aquatic exercise, resistance exercise, and mind-body exercise.

Three recommendations focused on diet. Notably, the recommended diet is Mediterranean style. Two other recommendations were specifically against any other formal diet and against the use of dietary supplements. “The conditional recommendation for adhering to a Mediterranean-style diet, but not other formally defined diets, to improve RA-specific outcomes may be surprising to some clinicians,” said Bryant R. England, MD, PhD, of the University of Nebraska Medical Center, Omaha, and one of the guideline’s coprincipal investigators, in a press release. “The voting panel acknowledged, however, that other health indications may exist for alternative diet and dietary supplements, which makes it crucial for clinicians and patients to engage in shared decision-making,” Dr. England said.

Nearly half of the 28 recommendations (13) focused on rehabilitation, but all were conditional. These included comprehensive occupational and physical therapy and hand therapy, as well as the use of splinting, orthoses, compression, bracing, and taping of affected areas. Other conditional recommendations supported the use of joint protection techniques, assistive devices, adaptive equipment, and/or environmental adaptations. The authors also included a conditional recommendation for vocational rehabilitation and work-site evaluations and/or modifications.

A category of additional integrative interventions included recommendations against both electrotherapy and chiropractic care. However, conditional recommendations were positive for acupuncture, massage therapy, and thermal modalities. Conditional recommendations also supported cognitive-behavioral therapy and/or mind-body strategies, and a standardized self-management program.

The guideline was developed by an interprofessional voting panel of 20 individuals with expertise in epidemiology, exercise physiology, GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology, integrative medicine, nursing, nutrition, occupational therapy, physical therapy, rheumatology, and social work, as well as three individuals who have RA. The panel developed questions, conducted a literature review, and used the GRADE approach to rate the certainty of evidence.

“These recommendations are specific to RA management, understanding that other medical indications and general health benefits may exist for many of these interventions,” the authors write in the summary statement.

The range of interventions shows both the importance of an interprofessional team–based approach to RA management and the need to engage patients in shared decision-making, they said.

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

Exercise tops the list of 28 recommendations in a guideline for integrative interventions in patients with rheumatoid arthritis developed by the American College of Rheumatology.

The guideline is specific to RA and presents integrative interventions to accompany treatment with disease-modifying antirheumatic drugs (DMARDs), according to a summary statement issued by the ACR. The summary was approved by the ACR Board of Directors on Oct. 31, and the recommendations are part of a manuscript that will be submitted for publication in both Arthritis & Rheumatology and Arthritis Care & Research.

Consistent engagement in exercise earned the only strong recommendation; the other 27 were conditional. In the exercise category, the authors offered conditional recommendations for aerobic exercise, aquatic exercise, resistance exercise, and mind-body exercise.

Three recommendations focused on diet. Notably, the recommended diet is Mediterranean style. Two other recommendations were specifically against any other formal diet and against the use of dietary supplements. “The conditional recommendation for adhering to a Mediterranean-style diet, but not other formally defined diets, to improve RA-specific outcomes may be surprising to some clinicians,” said Bryant R. England, MD, PhD, of the University of Nebraska Medical Center, Omaha, and one of the guideline’s coprincipal investigators, in a press release. “The voting panel acknowledged, however, that other health indications may exist for alternative diet and dietary supplements, which makes it crucial for clinicians and patients to engage in shared decision-making,” Dr. England said.

Nearly half of the 28 recommendations (13) focused on rehabilitation, but all were conditional. These included comprehensive occupational and physical therapy and hand therapy, as well as the use of splinting, orthoses, compression, bracing, and taping of affected areas. Other conditional recommendations supported the use of joint protection techniques, assistive devices, adaptive equipment, and/or environmental adaptations. The authors also included a conditional recommendation for vocational rehabilitation and work-site evaluations and/or modifications.

A category of additional integrative interventions included recommendations against both electrotherapy and chiropractic care. However, conditional recommendations were positive for acupuncture, massage therapy, and thermal modalities. Conditional recommendations also supported cognitive-behavioral therapy and/or mind-body strategies, and a standardized self-management program.

The guideline was developed by an interprofessional voting panel of 20 individuals with expertise in epidemiology, exercise physiology, GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology, integrative medicine, nursing, nutrition, occupational therapy, physical therapy, rheumatology, and social work, as well as three individuals who have RA. The panel developed questions, conducted a literature review, and used the GRADE approach to rate the certainty of evidence.

“These recommendations are specific to RA management, understanding that other medical indications and general health benefits may exist for many of these interventions,” the authors write in the summary statement.

The range of interventions shows both the importance of an interprofessional team–based approach to RA management and the need to engage patients in shared decision-making, they said.

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

Exercise tops the list of 28 recommendations in a guideline for integrative interventions in patients with rheumatoid arthritis developed by the American College of Rheumatology.

The guideline is specific to RA and presents integrative interventions to accompany treatment with disease-modifying antirheumatic drugs (DMARDs), according to a summary statement issued by the ACR. The summary was approved by the ACR Board of Directors on Oct. 31, and the recommendations are part of a manuscript that will be submitted for publication in both Arthritis & Rheumatology and Arthritis Care & Research.

Consistent engagement in exercise earned the only strong recommendation; the other 27 were conditional. In the exercise category, the authors offered conditional recommendations for aerobic exercise, aquatic exercise, resistance exercise, and mind-body exercise.

Three recommendations focused on diet. Notably, the recommended diet is Mediterranean style. Two other recommendations were specifically against any other formal diet and against the use of dietary supplements. “The conditional recommendation for adhering to a Mediterranean-style diet, but not other formally defined diets, to improve RA-specific outcomes may be surprising to some clinicians,” said Bryant R. England, MD, PhD, of the University of Nebraska Medical Center, Omaha, and one of the guideline’s coprincipal investigators, in a press release. “The voting panel acknowledged, however, that other health indications may exist for alternative diet and dietary supplements, which makes it crucial for clinicians and patients to engage in shared decision-making,” Dr. England said.

Nearly half of the 28 recommendations (13) focused on rehabilitation, but all were conditional. These included comprehensive occupational and physical therapy and hand therapy, as well as the use of splinting, orthoses, compression, bracing, and taping of affected areas. Other conditional recommendations supported the use of joint protection techniques, assistive devices, adaptive equipment, and/or environmental adaptations. The authors also included a conditional recommendation for vocational rehabilitation and work-site evaluations and/or modifications.

A category of additional integrative interventions included recommendations against both electrotherapy and chiropractic care. However, conditional recommendations were positive for acupuncture, massage therapy, and thermal modalities. Conditional recommendations also supported cognitive-behavioral therapy and/or mind-body strategies, and a standardized self-management program.

The guideline was developed by an interprofessional voting panel of 20 individuals with expertise in epidemiology, exercise physiology, GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology, integrative medicine, nursing, nutrition, occupational therapy, physical therapy, rheumatology, and social work, as well as three individuals who have RA. The panel developed questions, conducted a literature review, and used the GRADE approach to rate the certainty of evidence.

“These recommendations are specific to RA management, understanding that other medical indications and general health benefits may exist for many of these interventions,” the authors write in the summary statement.

The range of interventions shows both the importance of an interprofessional team–based approach to RA management and the need to engage patients in shared decision-making, they said.

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

Staying mentally healthy is essential for everyone, and it’s vital for physicians. As medical professionals, you’re continually exposed to overwork, burnout, stressful situations, and challenging ethical decisions. Yet seeking help for mental health care may be last on your to-do list – or completely off your radar.

That’s sad and dangerous, since the American College of Emergency Physicians said 300-400 physicians die by suicide each year, and the stigma keeps 69% of female physicians from seeking mental health care, according to a prepandemic study.

In the 2022 Medscape Physician Suicide Report, 11% of female doctors and 9% of male doctors said they have had thoughts of suicide, and 64% experienced colloquial depression (feeling down, sad, or blue).

What’s more, physicians are typically seen as strong and capable and are often put on a pedestal by loved ones, patients, and the public and thought of as superhuman. No wonder it isn’t easy when you need to take time away to decompress and treat your mental well-being.

“There is a real fear for physicians when it comes to getting mental health care,” said Emil Tsai, MD, PhD, MAS, professor at the department of psychiatry and behavioral sciences at the University of California, Los Angeles, and an internationally reputed scientist in neurosciences and brain disorders.

The fear, said Dr. Tsai, comes from the stigma of mental health issues, potential repercussions to employment, and conceivable medical board suspension or revocation of your medical license.

Dr. Tsai said in an interview that to combat anxiety about “punishment” that many physicians fear when seeking care for their mental health, we must allow physicians to take time away from their day-to-day patient care for respite and treatment without reprisal.

Since the medical profession is high stress and has a high depression and suicide rate, finding solutions is imperative. And physicians must feel supported enough to seek treatment when needed. So how can we normalize seeking mental health care among physicians?
 

Get honest about stress and burnout

The only way to normalize any behavior is to be open and candid, Dr. Tsai said in an interview. The mental health conversation must occur across the board, not just within the medical profession.

“The greatest thing we can do to try and lift the burden that we place on physicians is to be willing to talk and be honest about the stress that physicians deal with and the importance of everyone feeling free to seek treatment and rest to strengthen their mental health,” said Dr. Tsai.

The more we talk about mental health and its treatment, the more we lessen the stigma, said Dr. Tsai. That could be more employer-employee check-ins, counseling as part of physician wellness, and programs structured so as not to construe a penal system.

“Mental health in the medical profession is a big issue and one that has to be met with the same compassion and care as it should be for any patient. We have annual physical checkups. Why don’t we offer annual mental health checkups for all, physicians included?” asked Dr. Tsai.
 

Evaluate the workload

Elizabeth Lombardo, PhD, psychologist, coach, and global keynote speaker, thinks that health care employers should reexamine their physicians’ workloads to see if they’re contributing to mental health issues.

The conversation on mental health in the workplace shouldn’t be about whether a certain person can handle stressors that are “normal” for health care settings. Instead, workplace managers in health care institutions should redefine workloads to ensure that physicians aren’t too heavily burdened with responsibilities that can cause overwork, burnout, and mental health problems,” she said.
 

Lessen the stigma

Even when physicians want to seek help for their psychological struggles, they may be weary of how their colleagues would react if they knew.

Raffaello Antonino, MD, clinical director at Therapy Central in London, said several underlying fears may exist at a physician’s core that prevent them from seeking care – being seen as weak, being judged as unfit to practice medicine, and the notion that “something is wrong with them.”

Dr. Antonino said we need to understand that physicians face challenges of bereavement and trauma derived from losing patients and the inability to save someone’s life. “These issues can easily develop into an accumulation of difficult, unprocessed emotions, later arising in symptoms and signs of PTSD, anxiety, and depression.”

Education is the best way to end this stigma, just like with any form of prejudice and stereotypes. For instance, we know that health care professionals are at risk of developing burnout. So, educating physicians on the symptoms and management of burnout and its consequences and prevention strategies is a must.

“Imagine what could happen if there were regular opportunities to work through the day’s events before signing out from a shift. The idea that individual weekly therapy is the only way to relieve mental distress is false,” said Lori McIsaac Bewsher, MSW, RSW, a trauma therapist and owner of a trauma-focused mental health clinic in New Brunswick.

“There are ways of integrating individual care into our doctor’s offices and hospitals that can be brief, effective, and confidential. The best way to introduce these interventions is early and collectively; no one is immune to the potential impact of exposure to trauma. The earlier these interventions can be accessed, the better the outcomes for everyone,” she said.

Dr. Antonino suggests, perhaps in the future, organizations can have “burnout checks” or mental health wellness checks for physicians akin to how we also have quick examinations for various physical ailments. What if physicians regularly answered a 10-question mental health survey as part of a burnout or trauma prevention strategy?

“Theirs is a profession and an identity which is often linked with a sense of strength, leadership and [benevolent] power: adjectives, which on the surface one might see as incompatible with what instead, unfortunately, and wrongly, may be associated with mental health issues,” said Dr. Antonino.
 

Keep it private

When it comes to removing the stigma from mental health care and treatment for physicians, privacy is top of mind. There needs to be some form of privacy protection for physicians who seek professional help for mental health reasons. Dr. Lombardo said physicians need to have the choice to keep their mental health journeys private. “Ideally, normalization should mean openly conversing about mental health, but for physicians, it can be a matter of life or death for their career, so the choice to remain private is something that should be afforded to them.”

Along those lines, the American Medical Association is pushing for system changes in legislative and regulatory arenas to support the mental health of practicing physicians, residents, and medical students. The organization is also urging health systems and state medical licensing bodies to remove questions on their applications that ask about prior treatment for mental health conditions.

Among many programs across the country, the Foundation of the Pennsylvania Medical Society has also created a Physicians’ Health Program, which provides confidential assessment, counseling, and referral services for physicians with mental health concerns.

“All of these initiatives are important in helping to destigmatize mental health issues among physicians,” said Harold Hong, MD, a board-certified psychiatrist in Raleigh, N.C.
 

Hail the benefits of treatment

Dr. Hong said to continue to destigmatize mental health among physicians and normalize its treatment, we not only have to emphasize how attending to mental health has individual benefits but also how it helps us help our patients.

“One key aspect that perhaps underpins this issue is the still present separation between mental and physical health, between mind and body, Dr. Hong said in an interview. “Feeling sad or angry or anxious should become a fact of life, a characteristic of being human, just like catching a cold or breaking a leg.”

It’s a normalization that, perhaps more than anything else, can lead the way for improving physicians’ mental health outcomes while also improving them for the rest of society. When society can finally see the health and well-being of someone in both their psychological and physical status, some of the stigmas may dissipate, and perhaps more physicians’ lives can be saved.

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

Staying mentally healthy is essential for everyone, and it’s vital for physicians. As medical professionals, you’re continually exposed to overwork, burnout, stressful situations, and challenging ethical decisions. Yet seeking help for mental health care may be last on your to-do list – or completely off your radar.

That’s sad and dangerous, since the American College of Emergency Physicians said 300-400 physicians die by suicide each year, and the stigma keeps 69% of female physicians from seeking mental health care, according to a prepandemic study.

In the 2022 Medscape Physician Suicide Report, 11% of female doctors and 9% of male doctors said they have had thoughts of suicide, and 64% experienced colloquial depression (feeling down, sad, or blue).

What’s more, physicians are typically seen as strong and capable and are often put on a pedestal by loved ones, patients, and the public and thought of as superhuman. No wonder it isn’t easy when you need to take time away to decompress and treat your mental well-being.

“There is a real fear for physicians when it comes to getting mental health care,” said Emil Tsai, MD, PhD, MAS, professor at the department of psychiatry and behavioral sciences at the University of California, Los Angeles, and an internationally reputed scientist in neurosciences and brain disorders.

The fear, said Dr. Tsai, comes from the stigma of mental health issues, potential repercussions to employment, and conceivable medical board suspension or revocation of your medical license.

Dr. Tsai said in an interview that to combat anxiety about “punishment” that many physicians fear when seeking care for their mental health, we must allow physicians to take time away from their day-to-day patient care for respite and treatment without reprisal.

Since the medical profession is high stress and has a high depression and suicide rate, finding solutions is imperative. And physicians must feel supported enough to seek treatment when needed. So how can we normalize seeking mental health care among physicians?
 

Get honest about stress and burnout

The only way to normalize any behavior is to be open and candid, Dr. Tsai said in an interview. The mental health conversation must occur across the board, not just within the medical profession.

“The greatest thing we can do to try and lift the burden that we place on physicians is to be willing to talk and be honest about the stress that physicians deal with and the importance of everyone feeling free to seek treatment and rest to strengthen their mental health,” said Dr. Tsai.

The more we talk about mental health and its treatment, the more we lessen the stigma, said Dr. Tsai. That could be more employer-employee check-ins, counseling as part of physician wellness, and programs structured so as not to construe a penal system.

“Mental health in the medical profession is a big issue and one that has to be met with the same compassion and care as it should be for any patient. We have annual physical checkups. Why don’t we offer annual mental health checkups for all, physicians included?” asked Dr. Tsai.
 

Evaluate the workload

Elizabeth Lombardo, PhD, psychologist, coach, and global keynote speaker, thinks that health care employers should reexamine their physicians’ workloads to see if they’re contributing to mental health issues.

The conversation on mental health in the workplace shouldn’t be about whether a certain person can handle stressors that are “normal” for health care settings. Instead, workplace managers in health care institutions should redefine workloads to ensure that physicians aren’t too heavily burdened with responsibilities that can cause overwork, burnout, and mental health problems,” she said.
 

Lessen the stigma

Even when physicians want to seek help for their psychological struggles, they may be weary of how their colleagues would react if they knew.

Raffaello Antonino, MD, clinical director at Therapy Central in London, said several underlying fears may exist at a physician’s core that prevent them from seeking care – being seen as weak, being judged as unfit to practice medicine, and the notion that “something is wrong with them.”

Dr. Antonino said we need to understand that physicians face challenges of bereavement and trauma derived from losing patients and the inability to save someone’s life. “These issues can easily develop into an accumulation of difficult, unprocessed emotions, later arising in symptoms and signs of PTSD, anxiety, and depression.”

Education is the best way to end this stigma, just like with any form of prejudice and stereotypes. For instance, we know that health care professionals are at risk of developing burnout. So, educating physicians on the symptoms and management of burnout and its consequences and prevention strategies is a must.

“Imagine what could happen if there were regular opportunities to work through the day’s events before signing out from a shift. The idea that individual weekly therapy is the only way to relieve mental distress is false,” said Lori McIsaac Bewsher, MSW, RSW, a trauma therapist and owner of a trauma-focused mental health clinic in New Brunswick.

“There are ways of integrating individual care into our doctor’s offices and hospitals that can be brief, effective, and confidential. The best way to introduce these interventions is early and collectively; no one is immune to the potential impact of exposure to trauma. The earlier these interventions can be accessed, the better the outcomes for everyone,” she said.

Dr. Antonino suggests, perhaps in the future, organizations can have “burnout checks” or mental health wellness checks for physicians akin to how we also have quick examinations for various physical ailments. What if physicians regularly answered a 10-question mental health survey as part of a burnout or trauma prevention strategy?

“Theirs is a profession and an identity which is often linked with a sense of strength, leadership and [benevolent] power: adjectives, which on the surface one might see as incompatible with what instead, unfortunately, and wrongly, may be associated with mental health issues,” said Dr. Antonino.
 

Keep it private

When it comes to removing the stigma from mental health care and treatment for physicians, privacy is top of mind. There needs to be some form of privacy protection for physicians who seek professional help for mental health reasons. Dr. Lombardo said physicians need to have the choice to keep their mental health journeys private. “Ideally, normalization should mean openly conversing about mental health, but for physicians, it can be a matter of life or death for their career, so the choice to remain private is something that should be afforded to them.”

Along those lines, the American Medical Association is pushing for system changes in legislative and regulatory arenas to support the mental health of practicing physicians, residents, and medical students. The organization is also urging health systems and state medical licensing bodies to remove questions on their applications that ask about prior treatment for mental health conditions.

Among many programs across the country, the Foundation of the Pennsylvania Medical Society has also created a Physicians’ Health Program, which provides confidential assessment, counseling, and referral services for physicians with mental health concerns.

“All of these initiatives are important in helping to destigmatize mental health issues among physicians,” said Harold Hong, MD, a board-certified psychiatrist in Raleigh, N.C.
 

Hail the benefits of treatment

Dr. Hong said to continue to destigmatize mental health among physicians and normalize its treatment, we not only have to emphasize how attending to mental health has individual benefits but also how it helps us help our patients.

“One key aspect that perhaps underpins this issue is the still present separation between mental and physical health, between mind and body, Dr. Hong said in an interview. “Feeling sad or angry or anxious should become a fact of life, a characteristic of being human, just like catching a cold or breaking a leg.”

It’s a normalization that, perhaps more than anything else, can lead the way for improving physicians’ mental health outcomes while also improving them for the rest of society. When society can finally see the health and well-being of someone in both their psychological and physical status, some of the stigmas may dissipate, and perhaps more physicians’ lives can be saved.

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

Staying mentally healthy is essential for everyone, and it’s vital for physicians. As medical professionals, you’re continually exposed to overwork, burnout, stressful situations, and challenging ethical decisions. Yet seeking help for mental health care may be last on your to-do list – or completely off your radar.

That’s sad and dangerous, since the American College of Emergency Physicians said 300-400 physicians die by suicide each year, and the stigma keeps 69% of female physicians from seeking mental health care, according to a prepandemic study.

In the 2022 Medscape Physician Suicide Report, 11% of female doctors and 9% of male doctors said they have had thoughts of suicide, and 64% experienced colloquial depression (feeling down, sad, or blue).

What’s more, physicians are typically seen as strong and capable and are often put on a pedestal by loved ones, patients, and the public and thought of as superhuman. No wonder it isn’t easy when you need to take time away to decompress and treat your mental well-being.

“There is a real fear for physicians when it comes to getting mental health care,” said Emil Tsai, MD, PhD, MAS, professor at the department of psychiatry and behavioral sciences at the University of California, Los Angeles, and an internationally reputed scientist in neurosciences and brain disorders.

The fear, said Dr. Tsai, comes from the stigma of mental health issues, potential repercussions to employment, and conceivable medical board suspension or revocation of your medical license.

Dr. Tsai said in an interview that to combat anxiety about “punishment” that many physicians fear when seeking care for their mental health, we must allow physicians to take time away from their day-to-day patient care for respite and treatment without reprisal.

Since the medical profession is high stress and has a high depression and suicide rate, finding solutions is imperative. And physicians must feel supported enough to seek treatment when needed. So how can we normalize seeking mental health care among physicians?
 

Get honest about stress and burnout

The only way to normalize any behavior is to be open and candid, Dr. Tsai said in an interview. The mental health conversation must occur across the board, not just within the medical profession.

“The greatest thing we can do to try and lift the burden that we place on physicians is to be willing to talk and be honest about the stress that physicians deal with and the importance of everyone feeling free to seek treatment and rest to strengthen their mental health,” said Dr. Tsai.

The more we talk about mental health and its treatment, the more we lessen the stigma, said Dr. Tsai. That could be more employer-employee check-ins, counseling as part of physician wellness, and programs structured so as not to construe a penal system.

“Mental health in the medical profession is a big issue and one that has to be met with the same compassion and care as it should be for any patient. We have annual physical checkups. Why don’t we offer annual mental health checkups for all, physicians included?” asked Dr. Tsai.
 

Evaluate the workload

Elizabeth Lombardo, PhD, psychologist, coach, and global keynote speaker, thinks that health care employers should reexamine their physicians’ workloads to see if they’re contributing to mental health issues.

The conversation on mental health in the workplace shouldn’t be about whether a certain person can handle stressors that are “normal” for health care settings. Instead, workplace managers in health care institutions should redefine workloads to ensure that physicians aren’t too heavily burdened with responsibilities that can cause overwork, burnout, and mental health problems,” she said.
 

Lessen the stigma

Even when physicians want to seek help for their psychological struggles, they may be weary of how their colleagues would react if they knew.

Raffaello Antonino, MD, clinical director at Therapy Central in London, said several underlying fears may exist at a physician’s core that prevent them from seeking care – being seen as weak, being judged as unfit to practice medicine, and the notion that “something is wrong with them.”

Dr. Antonino said we need to understand that physicians face challenges of bereavement and trauma derived from losing patients and the inability to save someone’s life. “These issues can easily develop into an accumulation of difficult, unprocessed emotions, later arising in symptoms and signs of PTSD, anxiety, and depression.”

Education is the best way to end this stigma, just like with any form of prejudice and stereotypes. For instance, we know that health care professionals are at risk of developing burnout. So, educating physicians on the symptoms and management of burnout and its consequences and prevention strategies is a must.

“Imagine what could happen if there were regular opportunities to work through the day’s events before signing out from a shift. The idea that individual weekly therapy is the only way to relieve mental distress is false,” said Lori McIsaac Bewsher, MSW, RSW, a trauma therapist and owner of a trauma-focused mental health clinic in New Brunswick.

“There are ways of integrating individual care into our doctor’s offices and hospitals that can be brief, effective, and confidential. The best way to introduce these interventions is early and collectively; no one is immune to the potential impact of exposure to trauma. The earlier these interventions can be accessed, the better the outcomes for everyone,” she said.

Dr. Antonino suggests, perhaps in the future, organizations can have “burnout checks” or mental health wellness checks for physicians akin to how we also have quick examinations for various physical ailments. What if physicians regularly answered a 10-question mental health survey as part of a burnout or trauma prevention strategy?

“Theirs is a profession and an identity which is often linked with a sense of strength, leadership and [benevolent] power: adjectives, which on the surface one might see as incompatible with what instead, unfortunately, and wrongly, may be associated with mental health issues,” said Dr. Antonino.
 

Keep it private

When it comes to removing the stigma from mental health care and treatment for physicians, privacy is top of mind. There needs to be some form of privacy protection for physicians who seek professional help for mental health reasons. Dr. Lombardo said physicians need to have the choice to keep their mental health journeys private. “Ideally, normalization should mean openly conversing about mental health, but for physicians, it can be a matter of life or death for their career, so the choice to remain private is something that should be afforded to them.”

Along those lines, the American Medical Association is pushing for system changes in legislative and regulatory arenas to support the mental health of practicing physicians, residents, and medical students. The organization is also urging health systems and state medical licensing bodies to remove questions on their applications that ask about prior treatment for mental health conditions.

Among many programs across the country, the Foundation of the Pennsylvania Medical Society has also created a Physicians’ Health Program, which provides confidential assessment, counseling, and referral services for physicians with mental health concerns.

“All of these initiatives are important in helping to destigmatize mental health issues among physicians,” said Harold Hong, MD, a board-certified psychiatrist in Raleigh, N.C.
 

Hail the benefits of treatment

Dr. Hong said to continue to destigmatize mental health among physicians and normalize its treatment, we not only have to emphasize how attending to mental health has individual benefits but also how it helps us help our patients.

“One key aspect that perhaps underpins this issue is the still present separation between mental and physical health, between mind and body, Dr. Hong said in an interview. “Feeling sad or angry or anxious should become a fact of life, a characteristic of being human, just like catching a cold or breaking a leg.”

It’s a normalization that, perhaps more than anything else, can lead the way for improving physicians’ mental health outcomes while also improving them for the rest of society. When society can finally see the health and well-being of someone in both their psychological and physical status, some of the stigmas may dissipate, and perhaps more physicians’ lives can be saved.

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

The National Resident Matching Program’s (NRMP) decision to nix a proposal for a 2-day medical resident matching process has left some students scratching their heads about why the organization discounted the opinions of the majority of respondents – mostly medical students, residents, and fellows – who supported the change.

The program’s decision comes after nearly 3 months of feedback from the public, medical students, and education community. Although about 60% of public respondents believed the change could reduce stress and allow students more time for momentous career decisions, the program’s board of directors decided the disadvantages were “of greater consequence,” according to a Oct. 28 statement.

Those disadvantages included introducing application or interview behaviors that could increase students’ stress; potentially identifying partially matched or unmatched applicants, which could lead to bias; and extending the match process time for those applicants.

In addition, members of 12 medical education and student organizations raised other concerns, such as the proposed change not addressing high application numbers, according to the statement. NRMP has reported record numbers of applicants over the past few years, typically with more applicants than available program slots.

“While the testimony gave nod to the positive aspects of the proposal ... there was substantially more concern voiced about the potential negative consequences identified in the public comments,” NRMP President and CEO Donna L. Lamb, DHSc, MBA, BSN, told this news organization. Some of those issues could not be addressed without further study, so the board decided not to proceed with the proposal, she explained.

The proposal would have separated the Main Residency Match into two phases and replaced the Supplemental Offer and Acceptance Program (SOAP), in which unmatched or partially matched applicants apply for unfilled residency positions. Under the proposed change, each phase would have operated the same way, from rank order lists and using a matching algorithm to a pair of Match Days instead of a single day.

The two-phase process would have given students who didn’t match more time to carefully weigh residency programs – they can apply to up to 45 placements as part of SOAP – that will guide their career path for the next few years, PGY-1 intern Asim A., who asked not to be identified further, told this news organization. The alternative is a hasty decision once students learn which residency spots are available, he added. “Applicants would have breathing room to make a more informed decision.”

Asim, who is Canadian, said he is participating in a transitional year in internal medicine in the hopes of being matched into internal medicine or psychiatry. He said Canada’s two-phase match is a “lot less stressful” than the U.S. system.

Meanwhile, students on Reddit’s medical school community also questioned NRMP’s decision.

“A significant majority of those surveyed thought it would be beneficial. But NRMP decides to not go through with it,” one Reddit user wrote. Another posted, “The one thing that could have improved the match and they chose not to do it.”

Others supported the decision to retain a 1-day match.

“I think this was the right call,” Bryan Carmody, MD, an outspoken medical education blogger, tweeted after learning of NRMP’s decision. Dr. Carmody, a pediatric nephrologist, previously expressed to this news organization misgivings about whether the two-phase match would make it difficult for programs to thoroughly review candidates and vice versa. He was concerned that it would compress the interview season and pressure programs to rapidly review applicants and conduct interviews.

More than 8,000 people responded to the public survey that began in August and ran for a month. Nearly two-thirds of the respondents (60%) were students, residents, or fellows. About 25% included faculty, program directors, and staff. Among the survey findings, respondents were equally divided between whether the two-phase match would be modestly advantageous (30%) or significantly advantageous (30%) compared to 20% who viewed it as modestly or significantly disadvantageous.

The NRMP said it would continue engaging with the community through focus groups and other means to improve the match experience and transition to residency.

“It is important to remember that a proposal is just that,” Dr. Lamb told this news orgnization, “an opportunity to discuss the pros and cons of an idea or framework ... and to mitigate unwanted consequences determined to be detrimental to learners and programs.”

The NRMP will involve the community in future discussions “to continue to give learners a voice,” she said.

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

The National Resident Matching Program’s (NRMP) decision to nix a proposal for a 2-day medical resident matching process has left some students scratching their heads about why the organization discounted the opinions of the majority of respondents – mostly medical students, residents, and fellows – who supported the change.

The program’s decision comes after nearly 3 months of feedback from the public, medical students, and education community. Although about 60% of public respondents believed the change could reduce stress and allow students more time for momentous career decisions, the program’s board of directors decided the disadvantages were “of greater consequence,” according to a Oct. 28 statement.

Those disadvantages included introducing application or interview behaviors that could increase students’ stress; potentially identifying partially matched or unmatched applicants, which could lead to bias; and extending the match process time for those applicants.

In addition, members of 12 medical education and student organizations raised other concerns, such as the proposed change not addressing high application numbers, according to the statement. NRMP has reported record numbers of applicants over the past few years, typically with more applicants than available program slots.

“While the testimony gave nod to the positive aspects of the proposal ... there was substantially more concern voiced about the potential negative consequences identified in the public comments,” NRMP President and CEO Donna L. Lamb, DHSc, MBA, BSN, told this news organization. Some of those issues could not be addressed without further study, so the board decided not to proceed with the proposal, she explained.

The proposal would have separated the Main Residency Match into two phases and replaced the Supplemental Offer and Acceptance Program (SOAP), in which unmatched or partially matched applicants apply for unfilled residency positions. Under the proposed change, each phase would have operated the same way, from rank order lists and using a matching algorithm to a pair of Match Days instead of a single day.

The two-phase process would have given students who didn’t match more time to carefully weigh residency programs – they can apply to up to 45 placements as part of SOAP – that will guide their career path for the next few years, PGY-1 intern Asim A., who asked not to be identified further, told this news organization. The alternative is a hasty decision once students learn which residency spots are available, he added. “Applicants would have breathing room to make a more informed decision.”

Asim, who is Canadian, said he is participating in a transitional year in internal medicine in the hopes of being matched into internal medicine or psychiatry. He said Canada’s two-phase match is a “lot less stressful” than the U.S. system.

Meanwhile, students on Reddit’s medical school community also questioned NRMP’s decision.

“A significant majority of those surveyed thought it would be beneficial. But NRMP decides to not go through with it,” one Reddit user wrote. Another posted, “The one thing that could have improved the match and they chose not to do it.”

Others supported the decision to retain a 1-day match.

“I think this was the right call,” Bryan Carmody, MD, an outspoken medical education blogger, tweeted after learning of NRMP’s decision. Dr. Carmody, a pediatric nephrologist, previously expressed to this news organization misgivings about whether the two-phase match would make it difficult for programs to thoroughly review candidates and vice versa. He was concerned that it would compress the interview season and pressure programs to rapidly review applicants and conduct interviews.

More than 8,000 people responded to the public survey that began in August and ran for a month. Nearly two-thirds of the respondents (60%) were students, residents, or fellows. About 25% included faculty, program directors, and staff. Among the survey findings, respondents were equally divided between whether the two-phase match would be modestly advantageous (30%) or significantly advantageous (30%) compared to 20% who viewed it as modestly or significantly disadvantageous.

The NRMP said it would continue engaging with the community through focus groups and other means to improve the match experience and transition to residency.

“It is important to remember that a proposal is just that,” Dr. Lamb told this news orgnization, “an opportunity to discuss the pros and cons of an idea or framework ... and to mitigate unwanted consequences determined to be detrimental to learners and programs.”

The NRMP will involve the community in future discussions “to continue to give learners a voice,” she said.

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

The National Resident Matching Program’s (NRMP) decision to nix a proposal for a 2-day medical resident matching process has left some students scratching their heads about why the organization discounted the opinions of the majority of respondents – mostly medical students, residents, and fellows – who supported the change.

The program’s decision comes after nearly 3 months of feedback from the public, medical students, and education community. Although about 60% of public respondents believed the change could reduce stress and allow students more time for momentous career decisions, the program’s board of directors decided the disadvantages were “of greater consequence,” according to a Oct. 28 statement.

Those disadvantages included introducing application or interview behaviors that could increase students’ stress; potentially identifying partially matched or unmatched applicants, which could lead to bias; and extending the match process time for those applicants.

In addition, members of 12 medical education and student organizations raised other concerns, such as the proposed change not addressing high application numbers, according to the statement. NRMP has reported record numbers of applicants over the past few years, typically with more applicants than available program slots.

“While the testimony gave nod to the positive aspects of the proposal ... there was substantially more concern voiced about the potential negative consequences identified in the public comments,” NRMP President and CEO Donna L. Lamb, DHSc, MBA, BSN, told this news organization. Some of those issues could not be addressed without further study, so the board decided not to proceed with the proposal, she explained.

The proposal would have separated the Main Residency Match into two phases and replaced the Supplemental Offer and Acceptance Program (SOAP), in which unmatched or partially matched applicants apply for unfilled residency positions. Under the proposed change, each phase would have operated the same way, from rank order lists and using a matching algorithm to a pair of Match Days instead of a single day.

The two-phase process would have given students who didn’t match more time to carefully weigh residency programs – they can apply to up to 45 placements as part of SOAP – that will guide their career path for the next few years, PGY-1 intern Asim A., who asked not to be identified further, told this news organization. The alternative is a hasty decision once students learn which residency spots are available, he added. “Applicants would have breathing room to make a more informed decision.”

Asim, who is Canadian, said he is participating in a transitional year in internal medicine in the hopes of being matched into internal medicine or psychiatry. He said Canada’s two-phase match is a “lot less stressful” than the U.S. system.

Meanwhile, students on Reddit’s medical school community also questioned NRMP’s decision.

“A significant majority of those surveyed thought it would be beneficial. But NRMP decides to not go through with it,” one Reddit user wrote. Another posted, “The one thing that could have improved the match and they chose not to do it.”

Others supported the decision to retain a 1-day match.

“I think this was the right call,” Bryan Carmody, MD, an outspoken medical education blogger, tweeted after learning of NRMP’s decision. Dr. Carmody, a pediatric nephrologist, previously expressed to this news organization misgivings about whether the two-phase match would make it difficult for programs to thoroughly review candidates and vice versa. He was concerned that it would compress the interview season and pressure programs to rapidly review applicants and conduct interviews.

More than 8,000 people responded to the public survey that began in August and ran for a month. Nearly two-thirds of the respondents (60%) were students, residents, or fellows. About 25% included faculty, program directors, and staff. Among the survey findings, respondents were equally divided between whether the two-phase match would be modestly advantageous (30%) or significantly advantageous (30%) compared to 20% who viewed it as modestly or significantly disadvantageous.

The NRMP said it would continue engaging with the community through focus groups and other means to improve the match experience and transition to residency.

“It is important to remember that a proposal is just that,” Dr. Lamb told this news orgnization, “an opportunity to discuss the pros and cons of an idea or framework ... and to mitigate unwanted consequences determined to be detrimental to learners and programs.”

The NRMP will involve the community in future discussions “to continue to give learners a voice,” she said.

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

Nondisabling relapses that occur early in the course of relapsing-remitting multiple sclerosis (RRMS) signal faster accumulation of disability relative to no early relapses, new research suggests. However, in the large registry study, this association was not found in patients treated with high-efficacy, disease-modifying therapies (DMTs) early on.

The results suggest that nondisabling relapses “should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” said lead author Cyrus Daruwalla, MD, department of clinical neurosciences at the University of Cambridge, and Addenbrooke’s Hospital, Cambridge, England.

Dr. Daruwalla presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Questioning EMA restrictions 

“We designed this project because regulators, including EMA [European Medicines Agency], restrict the use of certain DMTs to only those with disabling relapses. In particular, natalizumab [Tysabri] and fingolimod [Gilenya] can only be used as the first-line therapy for people with rapidly evolving, severe MS – which includes having two disabling relapses in a year,” Dr. Daruwalla noted.

“In clinic, when we see somebody who has a nondisabling relapse, we’re left with the question of what is the prognostic significance of that relapse, and how should it influence treatment decisions,” he added.

Using prospectively collected data from the MSBase international registry, the researchers examined data on individuals with RRMS and complete early relapse severity information. 

They compared patients with exclusively nondisabling relapses in the 2 years after definitive RRMS diagnosis with peers with no relapses within this time frame.

To mitigate the confounding effect of DMT use, the investigators performed analyses in participants untreated during follow-up, and then in those who received only older or “platform” therapies (interferon-beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) during follow-up.

In the untreated cohort, 285 patients had nondisabling relapses and 4,717 had no relapses during the 2 years after diagnosis. Those with early nondisabling relapses had a significantly increased risk for disability accumulation (adjusted hazard ratio [aHR], 1.29; 95% confidence interval [CI], 1.00-1.68).

In the treated cohort, 1,074 patients had nondisabling early relapses and 7,262 did not. 

In this cohort, those treated with “platform” DMTs who had nondisabling relapses showed a significantly increased risk for disability accumulation compared with treated peers who had no relapses (aHR, 1.33; 95% CI, 1.15-1.54).

Notably, said Dr. Daruwalla, in patients treated at any point during follow-up with high-efficacy DMTs, including monoclonal antibodies, sphingosphine-1 phosphate modulators, and hematopoietic stem cell transplantation, there was no difference in disability accumulation between patients who did and did not experience nondisabling relapses (aHR, 0.90; 95% CI, 0.71-1.13).

The data clearly show that early nondisabling relapses are associated with a higher risk of disability accumulation than no early relapses in people with relapsing remitting MS,” Dr. Daruwalla said.

However, he noted, treatment with high-efficacy DMTs offers protection against disability accumulations.

“Therefore, contrary to EMA guidance, nondisabling relapses should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” he added.
 

Valuable, confirmatory data

Patricia Coyle, MD, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University, called the study “valuable.”

“It confirms prior data that having relapses is bad in MS even if they are mild, and provides additional modest data in support of high-efficacy versus moderate-efficacy DMT,” said Dr. Coyle, who was not involved with the research.

“Although certainly not definitive, it adds to data supporting high-efficacy as preferred treatment [and] addresses a completely arbitrary governmental limitation to DMT use in Europe,” she added.

The study had no commercial funding. Dr. Daruwalla has reported no relevant financial relationships. Dr. Coyle reports having received consulting fees from Accordant, Biogen, Bristol-Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio; and grant funding from Actelion, Alkermes, Bristol-Myers Squibb, CorEvitas, Genentech/Roche, Sanofi Genzyme, MedDay, and Novartis.

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

Nondisabling relapses that occur early in the course of relapsing-remitting multiple sclerosis (RRMS) signal faster accumulation of disability relative to no early relapses, new research suggests. However, in the large registry study, this association was not found in patients treated with high-efficacy, disease-modifying therapies (DMTs) early on.

The results suggest that nondisabling relapses “should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” said lead author Cyrus Daruwalla, MD, department of clinical neurosciences at the University of Cambridge, and Addenbrooke’s Hospital, Cambridge, England.

Dr. Daruwalla presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Questioning EMA restrictions 

“We designed this project because regulators, including EMA [European Medicines Agency], restrict the use of certain DMTs to only those with disabling relapses. In particular, natalizumab [Tysabri] and fingolimod [Gilenya] can only be used as the first-line therapy for people with rapidly evolving, severe MS – which includes having two disabling relapses in a year,” Dr. Daruwalla noted.

“In clinic, when we see somebody who has a nondisabling relapse, we’re left with the question of what is the prognostic significance of that relapse, and how should it influence treatment decisions,” he added.

Using prospectively collected data from the MSBase international registry, the researchers examined data on individuals with RRMS and complete early relapse severity information. 

They compared patients with exclusively nondisabling relapses in the 2 years after definitive RRMS diagnosis with peers with no relapses within this time frame.

To mitigate the confounding effect of DMT use, the investigators performed analyses in participants untreated during follow-up, and then in those who received only older or “platform” therapies (interferon-beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) during follow-up.

In the untreated cohort, 285 patients had nondisabling relapses and 4,717 had no relapses during the 2 years after diagnosis. Those with early nondisabling relapses had a significantly increased risk for disability accumulation (adjusted hazard ratio [aHR], 1.29; 95% confidence interval [CI], 1.00-1.68).

In the treated cohort, 1,074 patients had nondisabling early relapses and 7,262 did not. 

In this cohort, those treated with “platform” DMTs who had nondisabling relapses showed a significantly increased risk for disability accumulation compared with treated peers who had no relapses (aHR, 1.33; 95% CI, 1.15-1.54).

Notably, said Dr. Daruwalla, in patients treated at any point during follow-up with high-efficacy DMTs, including monoclonal antibodies, sphingosphine-1 phosphate modulators, and hematopoietic stem cell transplantation, there was no difference in disability accumulation between patients who did and did not experience nondisabling relapses (aHR, 0.90; 95% CI, 0.71-1.13).

The data clearly show that early nondisabling relapses are associated with a higher risk of disability accumulation than no early relapses in people with relapsing remitting MS,” Dr. Daruwalla said.

However, he noted, treatment with high-efficacy DMTs offers protection against disability accumulations.

“Therefore, contrary to EMA guidance, nondisabling relapses should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” he added.
 

Valuable, confirmatory data

Patricia Coyle, MD, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University, called the study “valuable.”

“It confirms prior data that having relapses is bad in MS even if they are mild, and provides additional modest data in support of high-efficacy versus moderate-efficacy DMT,” said Dr. Coyle, who was not involved with the research.

“Although certainly not definitive, it adds to data supporting high-efficacy as preferred treatment [and] addresses a completely arbitrary governmental limitation to DMT use in Europe,” she added.

The study had no commercial funding. Dr. Daruwalla has reported no relevant financial relationships. Dr. Coyle reports having received consulting fees from Accordant, Biogen, Bristol-Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio; and grant funding from Actelion, Alkermes, Bristol-Myers Squibb, CorEvitas, Genentech/Roche, Sanofi Genzyme, MedDay, and Novartis.

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

Nondisabling relapses that occur early in the course of relapsing-remitting multiple sclerosis (RRMS) signal faster accumulation of disability relative to no early relapses, new research suggests. However, in the large registry study, this association was not found in patients treated with high-efficacy, disease-modifying therapies (DMTs) early on.

The results suggest that nondisabling relapses “should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” said lead author Cyrus Daruwalla, MD, department of clinical neurosciences at the University of Cambridge, and Addenbrooke’s Hospital, Cambridge, England.

Dr. Daruwalla presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

Questioning EMA restrictions 

“We designed this project because regulators, including EMA [European Medicines Agency], restrict the use of certain DMTs to only those with disabling relapses. In particular, natalizumab [Tysabri] and fingolimod [Gilenya] can only be used as the first-line therapy for people with rapidly evolving, severe MS – which includes having two disabling relapses in a year,” Dr. Daruwalla noted.

“In clinic, when we see somebody who has a nondisabling relapse, we’re left with the question of what is the prognostic significance of that relapse, and how should it influence treatment decisions,” he added.

Using prospectively collected data from the MSBase international registry, the researchers examined data on individuals with RRMS and complete early relapse severity information. 

They compared patients with exclusively nondisabling relapses in the 2 years after definitive RRMS diagnosis with peers with no relapses within this time frame.

To mitigate the confounding effect of DMT use, the investigators performed analyses in participants untreated during follow-up, and then in those who received only older or “platform” therapies (interferon-beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) during follow-up.

In the untreated cohort, 285 patients had nondisabling relapses and 4,717 had no relapses during the 2 years after diagnosis. Those with early nondisabling relapses had a significantly increased risk for disability accumulation (adjusted hazard ratio [aHR], 1.29; 95% confidence interval [CI], 1.00-1.68).

In the treated cohort, 1,074 patients had nondisabling early relapses and 7,262 did not. 

In this cohort, those treated with “platform” DMTs who had nondisabling relapses showed a significantly increased risk for disability accumulation compared with treated peers who had no relapses (aHR, 1.33; 95% CI, 1.15-1.54).

Notably, said Dr. Daruwalla, in patients treated at any point during follow-up with high-efficacy DMTs, including monoclonal antibodies, sphingosphine-1 phosphate modulators, and hematopoietic stem cell transplantation, there was no difference in disability accumulation between patients who did and did not experience nondisabling relapses (aHR, 0.90; 95% CI, 0.71-1.13).

The data clearly show that early nondisabling relapses are associated with a higher risk of disability accumulation than no early relapses in people with relapsing remitting MS,” Dr. Daruwalla said.

However, he noted, treatment with high-efficacy DMTs offers protection against disability accumulations.

“Therefore, contrary to EMA guidance, nondisabling relapses should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” he added.
 

Valuable, confirmatory data

Patricia Coyle, MD, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University, called the study “valuable.”

“It confirms prior data that having relapses is bad in MS even if they are mild, and provides additional modest data in support of high-efficacy versus moderate-efficacy DMT,” said Dr. Coyle, who was not involved with the research.

“Although certainly not definitive, it adds to data supporting high-efficacy as preferred treatment [and] addresses a completely arbitrary governmental limitation to DMT use in Europe,” she added.

The study had no commercial funding. Dr. Daruwalla has reported no relevant financial relationships. Dr. Coyle reports having received consulting fees from Accordant, Biogen, Bristol-Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio; and grant funding from Actelion, Alkermes, Bristol-Myers Squibb, CorEvitas, Genentech/Roche, Sanofi Genzyme, MedDay, and Novartis.

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

CHICAGO – In patients with chronic limb-threatening ischemia (CLTI) and a usable saphenous vein segment, a surgical procedure leads to better outcomes than an endovascular approach, according results of the multinational randomized BEST-CLI trial.

In that study, conducted with two cohorts, the advantage of surgery was limited to the group with an available saphenous vein, but in this group the advantage over an endovascular approach was substantial, according to Alik Farber, MD, chief of vascular and endovascular surgery at Boston University.

Ted Bosworth/MDedge News

“Bypass with adequate saphenous vein should be offered as a first-line treatment option for suitable candidates with CLTI as part of fully informed, shared decision-making,” Dr. Farber stated in presenting the results at the annual scientific sessions of the American Heart Association.

The study pursued two hypotheses, which is why CLTI patients were divided into two cohorts. For cohort 1, which was limited to CLTI patients with an available saphenous vein, it was predicted that surgery would be better than an endovascular approach. For cohort 2, which enrolled patients who needed an alternative conduit, the hypothesis was that endovascular procedures would prove superior.

The study confirmed the first hypothesis, but there was no difference between the two approaches for the composite primary outcome of major adverse limb events (MALE) in the second cohort.
 

Saphenous vein availability determined cohort

Candidates for the BEST-CLI (Best Endovascular versus Best Surgical Therapy in Patients with CLTI) trial had to have CLTI producing severe ischemia and to be judged by both surgeons and cardiovascular specialists to be candidates for both types of interventions. Eligible patients were then enrolled in cohort 1 if the saphenous vein was considered the best conduit on imaging. If not, they were enrolled in cohort 2.

Patients were randomized to undergo surgical or endovascular repair only after the cohort was assigned. The primary composite MALE endpoint consisted of an adjudicated first major reintervention, such as new bypass or thrombectomy, an above-the-ankle amputation, or death from any cause.

In cohort 1, the primary composite MALE endpoint was reached in 42.6% of those in surgical arm and 57.4% in the endovascular arm, translating into a 32% relative risk reduction (hazard ratio, 0.68; P < .001) in favor of surgery at the end of a median of 2.7 years of follow-up.

The main advantage was the difference in reinterventions. The lower rate in the surgical group (9.2% vs. 23.5%), translated into a 65% relative risk reduction for this endpoint (HR, 035; P < .001).

The reduction in above-ankle amputations in the surgical group (10.4% vs. 14.9%) was also significant (HR, 0.73; P = .04), but the reduction in all-cause mortality (33.0% vs. 37.6%) was not (HR, 0.98; P = .81).

BEST-CLI involved 150 sites in North America, Europe, and New Zealand. Cohort 1, which randomized 1,434 patients, was the larger of the two. In the second cohort, only 396 patients were randomized, which Dr. Farber said “might have been underpowered.”

The results were published in the New England Journal of Medicine simultaneously with presentation of the results at the meeting.

After a median follow-up of 1.6 years in cohort 2, the slightly lower proportion of patients who reached the composite MALE endpoint in the surgical group relative to the endovascular group (42.8% vs. 47.7%) did not translate into a significant advantage (HR, 0.79; P = .12).

For the individual components, the lower rate of reinterventions in the surgical arm (14.4% vs. 25.6%) did reach statistical significance (HR, 0.47; P = .002), but both amputation (14.9% vs. 14.1%) and all-cause death (26.3% vs. 24.1%) were numerically but not significantly higher in the surgical group.

The primary safety endpoint was major adverse cardiovascular events (MACE). This was not significantly different in either cohort. There were also no major differences between groups in the risk of perioperative complications.

Level 1 evidence provided for intervention choice

Overall, BEST-CLI showed that both surgical and endovascular revascularizations are effective and safe, according to Dr. Farber. As a result, he suggested that both can be considered even if a saphenous vein is available when specific patient characteristics make one more attractive than another.

Yet, in a general population with an available saphenous vein, these data provide “level 1 evidence” that a surgical approach should be the dominant choice, he added.

Ted Bosworth/MDedge News

A quality of life (QOL) substudy of BEST-CLI did not challenge this conclusion. Rather, the main finding was that restoring circulation by either approach has a major favorable impact on patient well-being, according to Matthew Menard, MD, codirector of endovascular surgery at Brigham and Women’s Hospital, Boston.

In this substudy, presented separately from the primary BEST-CLI results, that analysis confirmed that baseline QOL was extremely poor, whether measured with a disease specific instrument such as VascuQol, or generic instruments, such as SF-12.

Surgical or endovascular treatment produced clinically meaningful and sustained improvements in every QOL measure employed, according to Dr. Menard, and this was true in either cohort.
 

Results not necessarily relevant to all

These data are likely relevant to the patients evaluated, but “it is important to consider who made it into this trial,” according to Naomi M. Hamburg, MD, section chief of vascular biology at Boston University.

Ted Bosworth/MDedge News

Not least, patients had to be candidates for either surgical or endovascular repair to get into the study, omitting those patients not deemed by the investigators to be suited for either.

In addition, Dr. Hamburg pointed out that there was a low enrollment of Blacks (20%) and women (28%), two groups for whom CTLI is a common condition.

Lastly, Dr Hamburg questioned whether specific types of anatomy might be better suited to one procedure relative to another, a variable not considered in this study. Reassured by Dr. Farber that this will be explored in subsequent analyses of BEST-CLI data, Dr. Hamburg expressed interest in learning the results.

Dr. Hamburg was among those who spoke about the growing urgency to optimize strategies for early diagnosis and treatment of CTLI. She plugged the PAD National Action Plan as one of the efforts to thwart the coming wave of CTLI expected from the steep climb in the prevalence of diabetes in the United States.

Dr. Farber reported a financial relationship with Sanifit Therapeutics. The study was funded by the National Heart, Lung, and Blood Institute, but received additional support from multiple pharmaceutical companies. Dr. Menard reported a financial relationship with Janssen Pharmaceuticals. Dr. Hamburg reported financial relationships with Acceleron Pharma, Merck, NovoNordisk, and Sanifit.

CHICAGO – In patients with chronic limb-threatening ischemia (CLTI) and a usable saphenous vein segment, a surgical procedure leads to better outcomes than an endovascular approach, according results of the multinational randomized BEST-CLI trial.

In that study, conducted with two cohorts, the advantage of surgery was limited to the group with an available saphenous vein, but in this group the advantage over an endovascular approach was substantial, according to Alik Farber, MD, chief of vascular and endovascular surgery at Boston University.

Ted Bosworth/MDedge News

“Bypass with adequate saphenous vein should be offered as a first-line treatment option for suitable candidates with CLTI as part of fully informed, shared decision-making,” Dr. Farber stated in presenting the results at the annual scientific sessions of the American Heart Association.

The study pursued two hypotheses, which is why CLTI patients were divided into two cohorts. For cohort 1, which was limited to CLTI patients with an available saphenous vein, it was predicted that surgery would be better than an endovascular approach. For cohort 2, which enrolled patients who needed an alternative conduit, the hypothesis was that endovascular procedures would prove superior.

The study confirmed the first hypothesis, but there was no difference between the two approaches for the composite primary outcome of major adverse limb events (MALE) in the second cohort.
 

Saphenous vein availability determined cohort

Candidates for the BEST-CLI (Best Endovascular versus Best Surgical Therapy in Patients with CLTI) trial had to have CLTI producing severe ischemia and to be judged by both surgeons and cardiovascular specialists to be candidates for both types of interventions. Eligible patients were then enrolled in cohort 1 if the saphenous vein was considered the best conduit on imaging. If not, they were enrolled in cohort 2.

Patients were randomized to undergo surgical or endovascular repair only after the cohort was assigned. The primary composite MALE endpoint consisted of an adjudicated first major reintervention, such as new bypass or thrombectomy, an above-the-ankle amputation, or death from any cause.

In cohort 1, the primary composite MALE endpoint was reached in 42.6% of those in surgical arm and 57.4% in the endovascular arm, translating into a 32% relative risk reduction (hazard ratio, 0.68; P < .001) in favor of surgery at the end of a median of 2.7 years of follow-up.

The main advantage was the difference in reinterventions. The lower rate in the surgical group (9.2% vs. 23.5%), translated into a 65% relative risk reduction for this endpoint (HR, 035; P < .001).

The reduction in above-ankle amputations in the surgical group (10.4% vs. 14.9%) was also significant (HR, 0.73; P = .04), but the reduction in all-cause mortality (33.0% vs. 37.6%) was not (HR, 0.98; P = .81).

BEST-CLI involved 150 sites in North America, Europe, and New Zealand. Cohort 1, which randomized 1,434 patients, was the larger of the two. In the second cohort, only 396 patients were randomized, which Dr. Farber said “might have been underpowered.”

The results were published in the New England Journal of Medicine simultaneously with presentation of the results at the meeting.

After a median follow-up of 1.6 years in cohort 2, the slightly lower proportion of patients who reached the composite MALE endpoint in the surgical group relative to the endovascular group (42.8% vs. 47.7%) did not translate into a significant advantage (HR, 0.79; P = .12).

For the individual components, the lower rate of reinterventions in the surgical arm (14.4% vs. 25.6%) did reach statistical significance (HR, 0.47; P = .002), but both amputation (14.9% vs. 14.1%) and all-cause death (26.3% vs. 24.1%) were numerically but not significantly higher in the surgical group.

The primary safety endpoint was major adverse cardiovascular events (MACE). This was not significantly different in either cohort. There were also no major differences between groups in the risk of perioperative complications.

Level 1 evidence provided for intervention choice

Overall, BEST-CLI showed that both surgical and endovascular revascularizations are effective and safe, according to Dr. Farber. As a result, he suggested that both can be considered even if a saphenous vein is available when specific patient characteristics make one more attractive than another.

Yet, in a general population with an available saphenous vein, these data provide “level 1 evidence” that a surgical approach should be the dominant choice, he added.

Ted Bosworth/MDedge News

A quality of life (QOL) substudy of BEST-CLI did not challenge this conclusion. Rather, the main finding was that restoring circulation by either approach has a major favorable impact on patient well-being, according to Matthew Menard, MD, codirector of endovascular surgery at Brigham and Women’s Hospital, Boston.

In this substudy, presented separately from the primary BEST-CLI results, that analysis confirmed that baseline QOL was extremely poor, whether measured with a disease specific instrument such as VascuQol, or generic instruments, such as SF-12.

Surgical or endovascular treatment produced clinically meaningful and sustained improvements in every QOL measure employed, according to Dr. Menard, and this was true in either cohort.
 

Results not necessarily relevant to all

These data are likely relevant to the patients evaluated, but “it is important to consider who made it into this trial,” according to Naomi M. Hamburg, MD, section chief of vascular biology at Boston University.

Ted Bosworth/MDedge News

Not least, patients had to be candidates for either surgical or endovascular repair to get into the study, omitting those patients not deemed by the investigators to be suited for either.

In addition, Dr. Hamburg pointed out that there was a low enrollment of Blacks (20%) and women (28%), two groups for whom CTLI is a common condition.

Lastly, Dr Hamburg questioned whether specific types of anatomy might be better suited to one procedure relative to another, a variable not considered in this study. Reassured by Dr. Farber that this will be explored in subsequent analyses of BEST-CLI data, Dr. Hamburg expressed interest in learning the results.

Dr. Hamburg was among those who spoke about the growing urgency to optimize strategies for early diagnosis and treatment of CTLI. She plugged the PAD National Action Plan as one of the efforts to thwart the coming wave of CTLI expected from the steep climb in the prevalence of diabetes in the United States.

Dr. Farber reported a financial relationship with Sanifit Therapeutics. The study was funded by the National Heart, Lung, and Blood Institute, but received additional support from multiple pharmaceutical companies. Dr. Menard reported a financial relationship with Janssen Pharmaceuticals. Dr. Hamburg reported financial relationships with Acceleron Pharma, Merck, NovoNordisk, and Sanifit.

CHICAGO – In patients with chronic limb-threatening ischemia (CLTI) and a usable saphenous vein segment, a surgical procedure leads to better outcomes than an endovascular approach, according results of the multinational randomized BEST-CLI trial.

In that study, conducted with two cohorts, the advantage of surgery was limited to the group with an available saphenous vein, but in this group the advantage over an endovascular approach was substantial, according to Alik Farber, MD, chief of vascular and endovascular surgery at Boston University.

Ted Bosworth/MDedge News

“Bypass with adequate saphenous vein should be offered as a first-line treatment option for suitable candidates with CLTI as part of fully informed, shared decision-making,” Dr. Farber stated in presenting the results at the annual scientific sessions of the American Heart Association.

The study pursued two hypotheses, which is why CLTI patients were divided into two cohorts. For cohort 1, which was limited to CLTI patients with an available saphenous vein, it was predicted that surgery would be better than an endovascular approach. For cohort 2, which enrolled patients who needed an alternative conduit, the hypothesis was that endovascular procedures would prove superior.

The study confirmed the first hypothesis, but there was no difference between the two approaches for the composite primary outcome of major adverse limb events (MALE) in the second cohort.
 

Saphenous vein availability determined cohort

Candidates for the BEST-CLI (Best Endovascular versus Best Surgical Therapy in Patients with CLTI) trial had to have CLTI producing severe ischemia and to be judged by both surgeons and cardiovascular specialists to be candidates for both types of interventions. Eligible patients were then enrolled in cohort 1 if the saphenous vein was considered the best conduit on imaging. If not, they were enrolled in cohort 2.

Patients were randomized to undergo surgical or endovascular repair only after the cohort was assigned. The primary composite MALE endpoint consisted of an adjudicated first major reintervention, such as new bypass or thrombectomy, an above-the-ankle amputation, or death from any cause.

In cohort 1, the primary composite MALE endpoint was reached in 42.6% of those in surgical arm and 57.4% in the endovascular arm, translating into a 32% relative risk reduction (hazard ratio, 0.68; P < .001) in favor of surgery at the end of a median of 2.7 years of follow-up.

The main advantage was the difference in reinterventions. The lower rate in the surgical group (9.2% vs. 23.5%), translated into a 65% relative risk reduction for this endpoint (HR, 035; P < .001).

The reduction in above-ankle amputations in the surgical group (10.4% vs. 14.9%) was also significant (HR, 0.73; P = .04), but the reduction in all-cause mortality (33.0% vs. 37.6%) was not (HR, 0.98; P = .81).

BEST-CLI involved 150 sites in North America, Europe, and New Zealand. Cohort 1, which randomized 1,434 patients, was the larger of the two. In the second cohort, only 396 patients were randomized, which Dr. Farber said “might have been underpowered.”

The results were published in the New England Journal of Medicine simultaneously with presentation of the results at the meeting.

After a median follow-up of 1.6 years in cohort 2, the slightly lower proportion of patients who reached the composite MALE endpoint in the surgical group relative to the endovascular group (42.8% vs. 47.7%) did not translate into a significant advantage (HR, 0.79; P = .12).

For the individual components, the lower rate of reinterventions in the surgical arm (14.4% vs. 25.6%) did reach statistical significance (HR, 0.47; P = .002), but both amputation (14.9% vs. 14.1%) and all-cause death (26.3% vs. 24.1%) were numerically but not significantly higher in the surgical group.

The primary safety endpoint was major adverse cardiovascular events (MACE). This was not significantly different in either cohort. There were also no major differences between groups in the risk of perioperative complications.

Level 1 evidence provided for intervention choice

Overall, BEST-CLI showed that both surgical and endovascular revascularizations are effective and safe, according to Dr. Farber. As a result, he suggested that both can be considered even if a saphenous vein is available when specific patient characteristics make one more attractive than another.

Yet, in a general population with an available saphenous vein, these data provide “level 1 evidence” that a surgical approach should be the dominant choice, he added.

Ted Bosworth/MDedge News

A quality of life (QOL) substudy of BEST-CLI did not challenge this conclusion. Rather, the main finding was that restoring circulation by either approach has a major favorable impact on patient well-being, according to Matthew Menard, MD, codirector of endovascular surgery at Brigham and Women’s Hospital, Boston.

In this substudy, presented separately from the primary BEST-CLI results, that analysis confirmed that baseline QOL was extremely poor, whether measured with a disease specific instrument such as VascuQol, or generic instruments, such as SF-12.

Surgical or endovascular treatment produced clinically meaningful and sustained improvements in every QOL measure employed, according to Dr. Menard, and this was true in either cohort.
 

Results not necessarily relevant to all

These data are likely relevant to the patients evaluated, but “it is important to consider who made it into this trial,” according to Naomi M. Hamburg, MD, section chief of vascular biology at Boston University.

Ted Bosworth/MDedge News

Not least, patients had to be candidates for either surgical or endovascular repair to get into the study, omitting those patients not deemed by the investigators to be suited for either.

In addition, Dr. Hamburg pointed out that there was a low enrollment of Blacks (20%) and women (28%), two groups for whom CTLI is a common condition.

Lastly, Dr Hamburg questioned whether specific types of anatomy might be better suited to one procedure relative to another, a variable not considered in this study. Reassured by Dr. Farber that this will be explored in subsequent analyses of BEST-CLI data, Dr. Hamburg expressed interest in learning the results.

Dr. Hamburg was among those who spoke about the growing urgency to optimize strategies for early diagnosis and treatment of CTLI. She plugged the PAD National Action Plan as one of the efforts to thwart the coming wave of CTLI expected from the steep climb in the prevalence of diabetes in the United States.

Dr. Farber reported a financial relationship with Sanifit Therapeutics. The study was funded by the National Heart, Lung, and Blood Institute, but received additional support from multiple pharmaceutical companies. Dr. Menard reported a financial relationship with Janssen Pharmaceuticals. Dr. Hamburg reported financial relationships with Acceleron Pharma, Merck, NovoNordisk, and Sanifit.

A new retrospective study provides more evidence that previous breast cancer diagnoses don’t disrupt the health of mothers and newborns in pregnancy: Women who became pregnant at least 12 months after breast cancer diagnosis weren’t more likely than a control group to have preterm births or suffer maternal/neonatal morbidity – even though they were more likely to undergo cesarean section.

“For patients who are more than 1 year out from the diagnosis of breast cancer, it may be safe and reasonable to consider pregnancy without significantly increased odds of maternal or neonatal complications,” said study lead author Kirsten Jorgensen, MD, a gynecologic oncology fellow at the University of Texas Houston School of Public Health, in an interview. “This study does not suggest there is no risk, but it does place the risk that exists in context with the risk that is associated with any pregnancy.”

The study appears in Obstetrics & Gynecology.

The researchers launched the analysis because “there is relatively little data to help guide patients, their oncologists, and their obstetricians as they navigate the potential for pregnancy after a cancer diagnosis,” Dr. Jorgensen said. “There have been prior studies looking at birth outcomes, but they often include people who become pregnant very shortly after diagnosis, which may skew results.”

Researchers used databases to track 30,021 women in California aged 18-45 who were diagnosed with breast cancer from 2000 to 2012. Of those, only 553 met the study criteria and conceived at least 1 year after a stage I-III breast cancer diagnosis (median age at delivery = 36; 50.6% non-Hispanic White, 23.9% Hispanic, 6.0% Black; 83.2% private insurance).

Study authors compared these women to a matched control group of 1,659 women without breast cancer.

After adjustment for various factors, there was no significant difference between the groups in terms of maternal outcomes – preterm birth at less than 37 weeks of gestation (12.5% in the breast cancer group vs. 10.0% in the control group; odds ratio = 1.29; 95% confidence interval, 0.95-1.74) or preterm birth at less than 32 weeks of gestation (1.3% vs. 1.6%, respectively, OR = 0.77; 95% CI, 0.34-1.79).

Researchers didn’t find a significant difference in neonatal outcomes either – small for gestational age (less than the 5th percentile, 3.1% vs. 5.0%, respectively; OR = 0.60, 95% CI, 0.35-1.03; less than the 10th percentile: 9.4% vs. 10%, respectively; OR = 0.94; 95% CI, 0.68-1.30), or neonatal morbidity (8.7% vs. 7.7%, respectively; OR = 1.15; 95% CI, 0.81-1.62).

“It is possible that breast cancer may have little impact because some breast cancer is treated only with surgery or radiation to the chest,” Dr. Jorgensen said. “These treatments likely do not impact fertility and may not impact a developing pregnancy.”

There were neonatal deaths: one in the breast cancer group and four in the control group. The researchers said the small number of deaths limited their ability to interpret the data.

Researchers found no evidence that treatment with chemotherapy affected outcomes. They did turn up a difference between the groups: those who’d had breast cancer were more likely to undergo cesarean delivery (45.6% in the breast cancer group, and 40.1% in the control group; OR = 1.25; 95% CI 1.03-1.53), However, offspring of women in the cesarean group weren’t more likely to have neonatal morbidity (OR = 1.15; 95% CI 0.81-1.62).

It’s hard to explain the higher rate of cesarean deliveries in the breast cancer group, Dr. Jorgensen said. “Overall, among our study population and the matched controls there was a high rate of cesarean section. It is possible there was bias on the provider side. Perhaps they intervened with cesarean section earlier among those with a history of breast cancer – a type of bias due to knowing the history of the patient. We attempted to match for other comorbidities that impact obstetric outcomes, but it is possible that we did not account for all of them.”

In an interview, Patricia A. Ganz, MD, director of cancer prevention and control research at University of California, Los Angeles, praised the new research.

It’s “a well-conducted study with state-of-the-art analysis and interpretation,” she said. “Based on my experience with patients I have cared for with breast cancer, there were no surprises here. Most have had uncomplicated pregnancies. This should be reassuring for women who wish to have children after treatment for breast cancer and clinicians should support this decision.”

As for the higher rate of cesarean delivery in breast-cancer survivors, she said “there may be a tendency to think of these as ‘high risk’ pregnancies, and C-sections may be selected at a more frequent rate as a result.”

The study was funded by the National Institutes of Health, including grants from the National Cancer Institute and the National Center for Advancing Translational Sciences. Dr. Jorgensen has no disclosures. Other authors disclosed advisory board service (Delfina Care) and payments from the NIH, Guidepoint, the Schlesinger Group, and Johnson & Johnson. Dr. Ganz has no disclosures.

A new retrospective study provides more evidence that previous breast cancer diagnoses don’t disrupt the health of mothers and newborns in pregnancy: Women who became pregnant at least 12 months after breast cancer diagnosis weren’t more likely than a control group to have preterm births or suffer maternal/neonatal morbidity – even though they were more likely to undergo cesarean section.

“For patients who are more than 1 year out from the diagnosis of breast cancer, it may be safe and reasonable to consider pregnancy without significantly increased odds of maternal or neonatal complications,” said study lead author Kirsten Jorgensen, MD, a gynecologic oncology fellow at the University of Texas Houston School of Public Health, in an interview. “This study does not suggest there is no risk, but it does place the risk that exists in context with the risk that is associated with any pregnancy.”

The study appears in Obstetrics & Gynecology.

The researchers launched the analysis because “there is relatively little data to help guide patients, their oncologists, and their obstetricians as they navigate the potential for pregnancy after a cancer diagnosis,” Dr. Jorgensen said. “There have been prior studies looking at birth outcomes, but they often include people who become pregnant very shortly after diagnosis, which may skew results.”

Researchers used databases to track 30,021 women in California aged 18-45 who were diagnosed with breast cancer from 2000 to 2012. Of those, only 553 met the study criteria and conceived at least 1 year after a stage I-III breast cancer diagnosis (median age at delivery = 36; 50.6% non-Hispanic White, 23.9% Hispanic, 6.0% Black; 83.2% private insurance).

Study authors compared these women to a matched control group of 1,659 women without breast cancer.

After adjustment for various factors, there was no significant difference between the groups in terms of maternal outcomes – preterm birth at less than 37 weeks of gestation (12.5% in the breast cancer group vs. 10.0% in the control group; odds ratio = 1.29; 95% confidence interval, 0.95-1.74) or preterm birth at less than 32 weeks of gestation (1.3% vs. 1.6%, respectively, OR = 0.77; 95% CI, 0.34-1.79).

Researchers didn’t find a significant difference in neonatal outcomes either – small for gestational age (less than the 5th percentile, 3.1% vs. 5.0%, respectively; OR = 0.60, 95% CI, 0.35-1.03; less than the 10th percentile: 9.4% vs. 10%, respectively; OR = 0.94; 95% CI, 0.68-1.30), or neonatal morbidity (8.7% vs. 7.7%, respectively; OR = 1.15; 95% CI, 0.81-1.62).

“It is possible that breast cancer may have little impact because some breast cancer is treated only with surgery or radiation to the chest,” Dr. Jorgensen said. “These treatments likely do not impact fertility and may not impact a developing pregnancy.”

There were neonatal deaths: one in the breast cancer group and four in the control group. The researchers said the small number of deaths limited their ability to interpret the data.

Researchers found no evidence that treatment with chemotherapy affected outcomes. They did turn up a difference between the groups: those who’d had breast cancer were more likely to undergo cesarean delivery (45.6% in the breast cancer group, and 40.1% in the control group; OR = 1.25; 95% CI 1.03-1.53), However, offspring of women in the cesarean group weren’t more likely to have neonatal morbidity (OR = 1.15; 95% CI 0.81-1.62).

It’s hard to explain the higher rate of cesarean deliveries in the breast cancer group, Dr. Jorgensen said. “Overall, among our study population and the matched controls there was a high rate of cesarean section. It is possible there was bias on the provider side. Perhaps they intervened with cesarean section earlier among those with a history of breast cancer – a type of bias due to knowing the history of the patient. We attempted to match for other comorbidities that impact obstetric outcomes, but it is possible that we did not account for all of them.”

In an interview, Patricia A. Ganz, MD, director of cancer prevention and control research at University of California, Los Angeles, praised the new research.

It’s “a well-conducted study with state-of-the-art analysis and interpretation,” she said. “Based on my experience with patients I have cared for with breast cancer, there were no surprises here. Most have had uncomplicated pregnancies. This should be reassuring for women who wish to have children after treatment for breast cancer and clinicians should support this decision.”

As for the higher rate of cesarean delivery in breast-cancer survivors, she said “there may be a tendency to think of these as ‘high risk’ pregnancies, and C-sections may be selected at a more frequent rate as a result.”

The study was funded by the National Institutes of Health, including grants from the National Cancer Institute and the National Center for Advancing Translational Sciences. Dr. Jorgensen has no disclosures. Other authors disclosed advisory board service (Delfina Care) and payments from the NIH, Guidepoint, the Schlesinger Group, and Johnson & Johnson. Dr. Ganz has no disclosures.

A new retrospective study provides more evidence that previous breast cancer diagnoses don’t disrupt the health of mothers and newborns in pregnancy: Women who became pregnant at least 12 months after breast cancer diagnosis weren’t more likely than a control group to have preterm births or suffer maternal/neonatal morbidity – even though they were more likely to undergo cesarean section.

“For patients who are more than 1 year out from the diagnosis of breast cancer, it may be safe and reasonable to consider pregnancy without significantly increased odds of maternal or neonatal complications,” said study lead author Kirsten Jorgensen, MD, a gynecologic oncology fellow at the University of Texas Houston School of Public Health, in an interview. “This study does not suggest there is no risk, but it does place the risk that exists in context with the risk that is associated with any pregnancy.”

The study appears in Obstetrics & Gynecology.

The researchers launched the analysis because “there is relatively little data to help guide patients, their oncologists, and their obstetricians as they navigate the potential for pregnancy after a cancer diagnosis,” Dr. Jorgensen said. “There have been prior studies looking at birth outcomes, but they often include people who become pregnant very shortly after diagnosis, which may skew results.”

Researchers used databases to track 30,021 women in California aged 18-45 who were diagnosed with breast cancer from 2000 to 2012. Of those, only 553 met the study criteria and conceived at least 1 year after a stage I-III breast cancer diagnosis (median age at delivery = 36; 50.6% non-Hispanic White, 23.9% Hispanic, 6.0% Black; 83.2% private insurance).

Study authors compared these women to a matched control group of 1,659 women without breast cancer.

After adjustment for various factors, there was no significant difference between the groups in terms of maternal outcomes – preterm birth at less than 37 weeks of gestation (12.5% in the breast cancer group vs. 10.0% in the control group; odds ratio = 1.29; 95% confidence interval, 0.95-1.74) or preterm birth at less than 32 weeks of gestation (1.3% vs. 1.6%, respectively, OR = 0.77; 95% CI, 0.34-1.79).

Researchers didn’t find a significant difference in neonatal outcomes either – small for gestational age (less than the 5th percentile, 3.1% vs. 5.0%, respectively; OR = 0.60, 95% CI, 0.35-1.03; less than the 10th percentile: 9.4% vs. 10%, respectively; OR = 0.94; 95% CI, 0.68-1.30), or neonatal morbidity (8.7% vs. 7.7%, respectively; OR = 1.15; 95% CI, 0.81-1.62).

“It is possible that breast cancer may have little impact because some breast cancer is treated only with surgery or radiation to the chest,” Dr. Jorgensen said. “These treatments likely do not impact fertility and may not impact a developing pregnancy.”

There were neonatal deaths: one in the breast cancer group and four in the control group. The researchers said the small number of deaths limited their ability to interpret the data.

Researchers found no evidence that treatment with chemotherapy affected outcomes. They did turn up a difference between the groups: those who’d had breast cancer were more likely to undergo cesarean delivery (45.6% in the breast cancer group, and 40.1% in the control group; OR = 1.25; 95% CI 1.03-1.53), However, offspring of women in the cesarean group weren’t more likely to have neonatal morbidity (OR = 1.15; 95% CI 0.81-1.62).

It’s hard to explain the higher rate of cesarean deliveries in the breast cancer group, Dr. Jorgensen said. “Overall, among our study population and the matched controls there was a high rate of cesarean section. It is possible there was bias on the provider side. Perhaps they intervened with cesarean section earlier among those with a history of breast cancer – a type of bias due to knowing the history of the patient. We attempted to match for other comorbidities that impact obstetric outcomes, but it is possible that we did not account for all of them.”

In an interview, Patricia A. Ganz, MD, director of cancer prevention and control research at University of California, Los Angeles, praised the new research.

It’s “a well-conducted study with state-of-the-art analysis and interpretation,” she said. “Based on my experience with patients I have cared for with breast cancer, there were no surprises here. Most have had uncomplicated pregnancies. This should be reassuring for women who wish to have children after treatment for breast cancer and clinicians should support this decision.”

As for the higher rate of cesarean delivery in breast-cancer survivors, she said “there may be a tendency to think of these as ‘high risk’ pregnancies, and C-sections may be selected at a more frequent rate as a result.”

The study was funded by the National Institutes of Health, including grants from the National Cancer Institute and the National Center for Advancing Translational Sciences. Dr. Jorgensen has no disclosures. Other authors disclosed advisory board service (Delfina Care) and payments from the NIH, Guidepoint, the Schlesinger Group, and Johnson & Johnson. Dr. Ganz has no disclosures.

The spotlight continues to shine on vitiligo as Lego has released the first-ever mini-character featuring the hallmark dark and light skin patches of the disease.

The character appears with the customizable array of players to assemble for a table football team.

It’s the latest representation of the disease as toymakers diversify their lines.

In May 2022, Mattel released a Ken doll with vitiligo after a Barbie with vitiligo was released in 2020. Rainbow High and other toy makers also have character versions.

The Lego addition follows a big summer medically for vitiligo as the first treatment was approved for repigmentation. In July, a cream formulation of ruxolitinib (Opzelura), a Janus kinase inhibitor, became the first repigmentation treatment approved by the Food and Drug Administration for nonsegmental vitiligo, the most common form of the disease.

Vitiligo is estimated to affect 1.9 million–2.8 million adults in the United States and more than 100 million people worldwide. It cuts across races and genders and can be psychologically painful for many who live with it.

John E. Harris, MD, director of the Vitiligo Clinic and Research Center at the University of Massachusetts, Worcester, wrote about the Lego character in his blog “Speaking of Vitiligo ...” saying: “I could not be more excited. This new minifigure also serves as a way to educate both children and adults who are not familiar with vitiligo about the disease.”

He noted that until recently vitiligo representation in kids’ toys has been limited. “By adding diversity such as representations of vitiligo in toys, it can help remove stigmas associated with vitiligo and give children more options that they can relate to.”

Erika Page of Richmond, Va., who founded and edits the vitiligo blog “Living Dappled,” told this news organization she was thrilled to see the new Lego character.

“Growing up I didn’t know anyone who looked like me, let alone a toy or a character,” she said. The message the representations send is important not just for the kids but for the parents of kids with vitiligo who want to help their kids in any way they can.

Ms. Page was diagnosed with vitiligo at age 7 and struggled emotionally in her high school and college years when she often looked in the mirror, saw “giraffe-like” spots, and cried. Over time she lost 100% of her pigment to the condition and today at age 33, lives with universal vitiligo or overall very pale skin.

She founded the Living Dappled blog 6 years ago to help people with the disease feel less alone. The Lego character will also help with that, she said.

“Growing up with vitiligo was so isolating and you felt so different,” Ms. Page said. “Today we see billboards and models and dolls and now Legos that look like us. I hope this is a first of many to come for Lego.”

Dr. Harris and Ms. Page declared no relevant financial relationships.

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

The spotlight continues to shine on vitiligo as Lego has released the first-ever mini-character featuring the hallmark dark and light skin patches of the disease.

The character appears with the customizable array of players to assemble for a table football team.

It’s the latest representation of the disease as toymakers diversify their lines.

In May 2022, Mattel released a Ken doll with vitiligo after a Barbie with vitiligo was released in 2020. Rainbow High and other toy makers also have character versions.

The Lego addition follows a big summer medically for vitiligo as the first treatment was approved for repigmentation. In July, a cream formulation of ruxolitinib (Opzelura), a Janus kinase inhibitor, became the first repigmentation treatment approved by the Food and Drug Administration for nonsegmental vitiligo, the most common form of the disease.

Vitiligo is estimated to affect 1.9 million–2.8 million adults in the United States and more than 100 million people worldwide. It cuts across races and genders and can be psychologically painful for many who live with it.

John E. Harris, MD, director of the Vitiligo Clinic and Research Center at the University of Massachusetts, Worcester, wrote about the Lego character in his blog “Speaking of Vitiligo ...” saying: “I could not be more excited. This new minifigure also serves as a way to educate both children and adults who are not familiar with vitiligo about the disease.”

He noted that until recently vitiligo representation in kids’ toys has been limited. “By adding diversity such as representations of vitiligo in toys, it can help remove stigmas associated with vitiligo and give children more options that they can relate to.”

Erika Page of Richmond, Va., who founded and edits the vitiligo blog “Living Dappled,” told this news organization she was thrilled to see the new Lego character.

“Growing up I didn’t know anyone who looked like me, let alone a toy or a character,” she said. The message the representations send is important not just for the kids but for the parents of kids with vitiligo who want to help their kids in any way they can.

Ms. Page was diagnosed with vitiligo at age 7 and struggled emotionally in her high school and college years when she often looked in the mirror, saw “giraffe-like” spots, and cried. Over time she lost 100% of her pigment to the condition and today at age 33, lives with universal vitiligo or overall very pale skin.

She founded the Living Dappled blog 6 years ago to help people with the disease feel less alone. The Lego character will also help with that, she said.

“Growing up with vitiligo was so isolating and you felt so different,” Ms. Page said. “Today we see billboards and models and dolls and now Legos that look like us. I hope this is a first of many to come for Lego.”

Dr. Harris and Ms. Page declared no relevant financial relationships.

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

The spotlight continues to shine on vitiligo as Lego has released the first-ever mini-character featuring the hallmark dark and light skin patches of the disease.

The character appears with the customizable array of players to assemble for a table football team.

It’s the latest representation of the disease as toymakers diversify their lines.

In May 2022, Mattel released a Ken doll with vitiligo after a Barbie with vitiligo was released in 2020. Rainbow High and other toy makers also have character versions.

The Lego addition follows a big summer medically for vitiligo as the first treatment was approved for repigmentation. In July, a cream formulation of ruxolitinib (Opzelura), a Janus kinase inhibitor, became the first repigmentation treatment approved by the Food and Drug Administration for nonsegmental vitiligo, the most common form of the disease.

Vitiligo is estimated to affect 1.9 million–2.8 million adults in the United States and more than 100 million people worldwide. It cuts across races and genders and can be psychologically painful for many who live with it.

John E. Harris, MD, director of the Vitiligo Clinic and Research Center at the University of Massachusetts, Worcester, wrote about the Lego character in his blog “Speaking of Vitiligo ...” saying: “I could not be more excited. This new minifigure also serves as a way to educate both children and adults who are not familiar with vitiligo about the disease.”

He noted that until recently vitiligo representation in kids’ toys has been limited. “By adding diversity such as representations of vitiligo in toys, it can help remove stigmas associated with vitiligo and give children more options that they can relate to.”

Erika Page of Richmond, Va., who founded and edits the vitiligo blog “Living Dappled,” told this news organization she was thrilled to see the new Lego character.

“Growing up I didn’t know anyone who looked like me, let alone a toy or a character,” she said. The message the representations send is important not just for the kids but for the parents of kids with vitiligo who want to help their kids in any way they can.

Ms. Page was diagnosed with vitiligo at age 7 and struggled emotionally in her high school and college years when she often looked in the mirror, saw “giraffe-like” spots, and cried. Over time she lost 100% of her pigment to the condition and today at age 33, lives with universal vitiligo or overall very pale skin.

She founded the Living Dappled blog 6 years ago to help people with the disease feel less alone. The Lego character will also help with that, she said.

“Growing up with vitiligo was so isolating and you felt so different,” Ms. Page said. “Today we see billboards and models and dolls and now Legos that look like us. I hope this is a first of many to come for Lego.”

Dr. Harris and Ms. Page declared no relevant financial relationships.

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

During screening colonoscopy, a scope withdrawal time (WT) of 9 minutes versus 6 minutes led to a reduced adenoma miss rate (AMR) and advanced adenoma miss rate (AAMR) and an improved adenoma detection rate (ADR), according to a randomized controlled trial conducted in China.

“Individual colonoscopists may acquire significant benefits in the ADR, AMR, AAMR, and high-risk adenoma miss rate from a 3-minute WT prolongation without compromising detection efficiency,” Zhao-Shen Li, MD, PhD, director, department of gastroenterology, Changhai Hospital and Second Military Medical University, Shanghai, said in an interview.

Based on evidence to date, the 9-minute WT “deserves to be considered as a new quality indicator to further optimize colonoscopy quality,” Dr. Li added.

The study is published online in the American Journal of Gastroenterology.

“This study certainly supports the notion that lengthening the examination time during colonoscopy results in more adenomas being detected,” Ziad F. Gellad, MD, who wasn’t involved in the study, told this news organization.

“When linking that with other studies showing a positive correlation between adenoma detection rate and interval cancers, we can conjecture that these longer exams will result in improved cancer detection. This makes intuitive sense,” said Dr. Gellad, associate professor of medicine, Duke University Medical Center, Durham, N.C.

In an earlier study, Dr. Li and colleagues found that prolonging the WT from a mean of 6 minutes to 9 minutes significantly improved the ADR (27.1% vs. 36.6%, P = .001).

Their latest study involved 733 asymptomatic adults aged 40-75 years undergoing screening colonoscopy by 15 gastroenterologists at 11 tertiary hospitals in China.

Participants were randomly allocated to segmental tandem screening colonoscopy with 9-minute withdrawal first (9MF) followed by 6-minute withdrawal (6MF) or vice versa.

In an intention-to-treat analysis, compared with 6MF, 9MF significantly reduced the lesion-level AMR (14.5% vs. 36.6%, P < .001), which was the primary outcome, and the participant-level AMR (10.9% vs. 25.9%; P < .001).

The 9MF also significantly reduced the AAMR (5.3% vs. 46.9%, P = .002), multiple AMR (20.7% vs. 56.5%; P = .01), and high-risk AMR (14.6% vs. 39.5%; P = .01) – without compromising detection efficiency.

The longer withdrawal time was also associated with a lower false-negative rate for adenomas (5.2% vs. 11.7%; P = .002) and high-risk adenomas (2.2% vs. 5%; P < .05), as well as a lower rate of shortening the surveillance schedule (P < .001).

A 9-minute mean WT also led to an improved ADR (42.3% vs. 33.5%, P = .02). The ADR improvement was associated with diminutive (P = .01), flat (P = .01), and tubular adenomas (P = .02).

Notably, colonoscopists with high ADRs (≥ 25%) in routine practice also showed a tendency of ADR improvement through a 3-minute prolongation (41% vs. 34.8%; P for interaction = .62), the investigators wrote.

Dr. Gellad said in an interview the study “reinforces the importance of careful inspection of the colonic mucosa during colonoscopy withdrawal. This should take as long as it takes to do it right, and that will vary by patient and by endoscopist.”

“Measurement of withdrawal time is helpful for quality improvement purposes when physician detection rates or miss rates are below goal,” Dr. Gellad added, “but timing the withdrawal should not be a goal in and of itself,”

The study was supported by the National Science and Technology Plan Project of the Ministry of Science and Technology of China. The authors reported no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and a cofounder of Higgs Boson.

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

During screening colonoscopy, a scope withdrawal time (WT) of 9 minutes versus 6 minutes led to a reduced adenoma miss rate (AMR) and advanced adenoma miss rate (AAMR) and an improved adenoma detection rate (ADR), according to a randomized controlled trial conducted in China.

“Individual colonoscopists may acquire significant benefits in the ADR, AMR, AAMR, and high-risk adenoma miss rate from a 3-minute WT prolongation without compromising detection efficiency,” Zhao-Shen Li, MD, PhD, director, department of gastroenterology, Changhai Hospital and Second Military Medical University, Shanghai, said in an interview.

Based on evidence to date, the 9-minute WT “deserves to be considered as a new quality indicator to further optimize colonoscopy quality,” Dr. Li added.

The study is published online in the American Journal of Gastroenterology.

“This study certainly supports the notion that lengthening the examination time during colonoscopy results in more adenomas being detected,” Ziad F. Gellad, MD, who wasn’t involved in the study, told this news organization.

“When linking that with other studies showing a positive correlation between adenoma detection rate and interval cancers, we can conjecture that these longer exams will result in improved cancer detection. This makes intuitive sense,” said Dr. Gellad, associate professor of medicine, Duke University Medical Center, Durham, N.C.

In an earlier study, Dr. Li and colleagues found that prolonging the WT from a mean of 6 minutes to 9 minutes significantly improved the ADR (27.1% vs. 36.6%, P = .001).

Their latest study involved 733 asymptomatic adults aged 40-75 years undergoing screening colonoscopy by 15 gastroenterologists at 11 tertiary hospitals in China.

Participants were randomly allocated to segmental tandem screening colonoscopy with 9-minute withdrawal first (9MF) followed by 6-minute withdrawal (6MF) or vice versa.

In an intention-to-treat analysis, compared with 6MF, 9MF significantly reduced the lesion-level AMR (14.5% vs. 36.6%, P < .001), which was the primary outcome, and the participant-level AMR (10.9% vs. 25.9%; P < .001).

The 9MF also significantly reduced the AAMR (5.3% vs. 46.9%, P = .002), multiple AMR (20.7% vs. 56.5%; P = .01), and high-risk AMR (14.6% vs. 39.5%; P = .01) – without compromising detection efficiency.

The longer withdrawal time was also associated with a lower false-negative rate for adenomas (5.2% vs. 11.7%; P = .002) and high-risk adenomas (2.2% vs. 5%; P < .05), as well as a lower rate of shortening the surveillance schedule (P < .001).

A 9-minute mean WT also led to an improved ADR (42.3% vs. 33.5%, P = .02). The ADR improvement was associated with diminutive (P = .01), flat (P = .01), and tubular adenomas (P = .02).

Notably, colonoscopists with high ADRs (≥ 25%) in routine practice also showed a tendency of ADR improvement through a 3-minute prolongation (41% vs. 34.8%; P for interaction = .62), the investigators wrote.

Dr. Gellad said in an interview the study “reinforces the importance of careful inspection of the colonic mucosa during colonoscopy withdrawal. This should take as long as it takes to do it right, and that will vary by patient and by endoscopist.”

“Measurement of withdrawal time is helpful for quality improvement purposes when physician detection rates or miss rates are below goal,” Dr. Gellad added, “but timing the withdrawal should not be a goal in and of itself,”

The study was supported by the National Science and Technology Plan Project of the Ministry of Science and Technology of China. The authors reported no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and a cofounder of Higgs Boson.

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

During screening colonoscopy, a scope withdrawal time (WT) of 9 minutes versus 6 minutes led to a reduced adenoma miss rate (AMR) and advanced adenoma miss rate (AAMR) and an improved adenoma detection rate (ADR), according to a randomized controlled trial conducted in China.

“Individual colonoscopists may acquire significant benefits in the ADR, AMR, AAMR, and high-risk adenoma miss rate from a 3-minute WT prolongation without compromising detection efficiency,” Zhao-Shen Li, MD, PhD, director, department of gastroenterology, Changhai Hospital and Second Military Medical University, Shanghai, said in an interview.

Based on evidence to date, the 9-minute WT “deserves to be considered as a new quality indicator to further optimize colonoscopy quality,” Dr. Li added.

The study is published online in the American Journal of Gastroenterology.

“This study certainly supports the notion that lengthening the examination time during colonoscopy results in more adenomas being detected,” Ziad F. Gellad, MD, who wasn’t involved in the study, told this news organization.

“When linking that with other studies showing a positive correlation between adenoma detection rate and interval cancers, we can conjecture that these longer exams will result in improved cancer detection. This makes intuitive sense,” said Dr. Gellad, associate professor of medicine, Duke University Medical Center, Durham, N.C.

In an earlier study, Dr. Li and colleagues found that prolonging the WT from a mean of 6 minutes to 9 minutes significantly improved the ADR (27.1% vs. 36.6%, P = .001).

Their latest study involved 733 asymptomatic adults aged 40-75 years undergoing screening colonoscopy by 15 gastroenterologists at 11 tertiary hospitals in China.

Participants were randomly allocated to segmental tandem screening colonoscopy with 9-minute withdrawal first (9MF) followed by 6-minute withdrawal (6MF) or vice versa.

In an intention-to-treat analysis, compared with 6MF, 9MF significantly reduced the lesion-level AMR (14.5% vs. 36.6%, P < .001), which was the primary outcome, and the participant-level AMR (10.9% vs. 25.9%; P < .001).

The 9MF also significantly reduced the AAMR (5.3% vs. 46.9%, P = .002), multiple AMR (20.7% vs. 56.5%; P = .01), and high-risk AMR (14.6% vs. 39.5%; P = .01) – without compromising detection efficiency.

The longer withdrawal time was also associated with a lower false-negative rate for adenomas (5.2% vs. 11.7%; P = .002) and high-risk adenomas (2.2% vs. 5%; P < .05), as well as a lower rate of shortening the surveillance schedule (P < .001).

A 9-minute mean WT also led to an improved ADR (42.3% vs. 33.5%, P = .02). The ADR improvement was associated with diminutive (P = .01), flat (P = .01), and tubular adenomas (P = .02).

Notably, colonoscopists with high ADRs (≥ 25%) in routine practice also showed a tendency of ADR improvement through a 3-minute prolongation (41% vs. 34.8%; P for interaction = .62), the investigators wrote.

Dr. Gellad said in an interview the study “reinforces the importance of careful inspection of the colonic mucosa during colonoscopy withdrawal. This should take as long as it takes to do it right, and that will vary by patient and by endoscopist.”

“Measurement of withdrawal time is helpful for quality improvement purposes when physician detection rates or miss rates are below goal,” Dr. Gellad added, “but timing the withdrawal should not be a goal in and of itself,”

The study was supported by the National Science and Technology Plan Project of the Ministry of Science and Technology of China. The authors reported no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and a cofounder of Higgs Boson.

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