Ob.Gyn. News

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The widely used antidiabetic drug metformin may cause genital birth defects such as undescended testicles and urethral problems in the male offspring of men who take the medication, researchers have found.

The association appears to involve the effects of metformin on the development of sperm during a critical window prior to conception. Female offspring were not affected. Although previous studies have linked diabetes with fertility problems in men, the latest study is the first to show that these problems can result from treatment rather than the disease itself, according to the researchers, whose findings appear in Annals of Internal Medicine.

“This is the first data to suggest that paternal metformin [use] may be associated with birth defects in children. As such, it would be early to begin to alter clinical practice,” Michael Eisenberg, MD, director of male reproductive medicine and surgery, department of urology, Stanford (Calif.) University, who is a coauthor of the study, said in an interview. “However, if it is confirmed in other populations, then it may begin to enter counseling discussions.”

Dr. Eisenberg added that eating a nutritious diet, exercising, and maintaining a healthy body weight “can improve a man’s health and likely his fertility as well.”

For the new study, Dr. Eisenberg and colleagues analyzed records in a registry of all 1.25 million births that occurred in Denmark between 1997 and 2016. The registry included information on birth defects and parental drug prescriptions.

Offspring were considered exposed to a diabetes drug if a father had filled one or more prescriptions for the medications during the 3 months prior to conception, when the fertilizing sperm would have been produced.

The final analysis included 1,116,779 offspring – all singleton births to women without a history of diabetes or essential hypertension – of whom 7,029 were exposed to diabetes drugs via the father, and 3.3% (n = 36,585) had one or more major birth defects.

Among male offspring whose fathers had taken metformin (n = 1,451), there was a 3.4-fold greater incidence of major genitourinary birth defects, according to the researchers. The study failed to find associations between birth defects and the use of insulin. Although a signal did emerge for sulfonylurea-based drugs, it did not reach statistical significance.

The risk associated with metformin did not appear for men who were prescribed the drug in the year before or after sperm development. Nor was it evident in siblings of the boys with birth defects who were not considered to have been exposed to the medication, the researchers reported.

In an editorial accompanying the journal article, Germaine Buck Louis, PhD, a reproductive and perinatal epidemiologist, wrote: “Given the prevalence of metformin use as first-line therapy for type 2 diabetes, corroboration of these findings is urgently needed.”

Dr. Louis, dean of the College of Health and Human Services at George Mason University, Washington, said a key limitation of the research is the lack of data on how well men in the study adhered to their diabetes treatment. Nevertheless, “clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal metformin use relative to other medications.”

The researchers received funding from the National Institutes of Health and the Centers for Disease Control and Prevention.

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

The widely used antidiabetic drug metformin may cause genital birth defects such as undescended testicles and urethral problems in the male offspring of men who take the medication, researchers have found.

The association appears to involve the effects of metformin on the development of sperm during a critical window prior to conception. Female offspring were not affected. Although previous studies have linked diabetes with fertility problems in men, the latest study is the first to show that these problems can result from treatment rather than the disease itself, according to the researchers, whose findings appear in Annals of Internal Medicine.

“This is the first data to suggest that paternal metformin [use] may be associated with birth defects in children. As such, it would be early to begin to alter clinical practice,” Michael Eisenberg, MD, director of male reproductive medicine and surgery, department of urology, Stanford (Calif.) University, who is a coauthor of the study, said in an interview. “However, if it is confirmed in other populations, then it may begin to enter counseling discussions.”

Dr. Eisenberg added that eating a nutritious diet, exercising, and maintaining a healthy body weight “can improve a man’s health and likely his fertility as well.”

For the new study, Dr. Eisenberg and colleagues analyzed records in a registry of all 1.25 million births that occurred in Denmark between 1997 and 2016. The registry included information on birth defects and parental drug prescriptions.

Offspring were considered exposed to a diabetes drug if a father had filled one or more prescriptions for the medications during the 3 months prior to conception, when the fertilizing sperm would have been produced.

The final analysis included 1,116,779 offspring – all singleton births to women without a history of diabetes or essential hypertension – of whom 7,029 were exposed to diabetes drugs via the father, and 3.3% (n = 36,585) had one or more major birth defects.

Among male offspring whose fathers had taken metformin (n = 1,451), there was a 3.4-fold greater incidence of major genitourinary birth defects, according to the researchers. The study failed to find associations between birth defects and the use of insulin. Although a signal did emerge for sulfonylurea-based drugs, it did not reach statistical significance.

The risk associated with metformin did not appear for men who were prescribed the drug in the year before or after sperm development. Nor was it evident in siblings of the boys with birth defects who were not considered to have been exposed to the medication, the researchers reported.

In an editorial accompanying the journal article, Germaine Buck Louis, PhD, a reproductive and perinatal epidemiologist, wrote: “Given the prevalence of metformin use as first-line therapy for type 2 diabetes, corroboration of these findings is urgently needed.”

Dr. Louis, dean of the College of Health and Human Services at George Mason University, Washington, said a key limitation of the research is the lack of data on how well men in the study adhered to their diabetes treatment. Nevertheless, “clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal metformin use relative to other medications.”

The researchers received funding from the National Institutes of Health and the Centers for Disease Control and Prevention.

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

The widely used antidiabetic drug metformin may cause genital birth defects such as undescended testicles and urethral problems in the male offspring of men who take the medication, researchers have found.

The association appears to involve the effects of metformin on the development of sperm during a critical window prior to conception. Female offspring were not affected. Although previous studies have linked diabetes with fertility problems in men, the latest study is the first to show that these problems can result from treatment rather than the disease itself, according to the researchers, whose findings appear in Annals of Internal Medicine.

“This is the first data to suggest that paternal metformin [use] may be associated with birth defects in children. As such, it would be early to begin to alter clinical practice,” Michael Eisenberg, MD, director of male reproductive medicine and surgery, department of urology, Stanford (Calif.) University, who is a coauthor of the study, said in an interview. “However, if it is confirmed in other populations, then it may begin to enter counseling discussions.”

Dr. Eisenberg added that eating a nutritious diet, exercising, and maintaining a healthy body weight “can improve a man’s health and likely his fertility as well.”

For the new study, Dr. Eisenberg and colleagues analyzed records in a registry of all 1.25 million births that occurred in Denmark between 1997 and 2016. The registry included information on birth defects and parental drug prescriptions.

Offspring were considered exposed to a diabetes drug if a father had filled one or more prescriptions for the medications during the 3 months prior to conception, when the fertilizing sperm would have been produced.

The final analysis included 1,116,779 offspring – all singleton births to women without a history of diabetes or essential hypertension – of whom 7,029 were exposed to diabetes drugs via the father, and 3.3% (n = 36,585) had one or more major birth defects.

Among male offspring whose fathers had taken metformin (n = 1,451), there was a 3.4-fold greater incidence of major genitourinary birth defects, according to the researchers. The study failed to find associations between birth defects and the use of insulin. Although a signal did emerge for sulfonylurea-based drugs, it did not reach statistical significance.

The risk associated with metformin did not appear for men who were prescribed the drug in the year before or after sperm development. Nor was it evident in siblings of the boys with birth defects who were not considered to have been exposed to the medication, the researchers reported.

In an editorial accompanying the journal article, Germaine Buck Louis, PhD, a reproductive and perinatal epidemiologist, wrote: “Given the prevalence of metformin use as first-line therapy for type 2 diabetes, corroboration of these findings is urgently needed.”

Dr. Louis, dean of the College of Health and Human Services at George Mason University, Washington, said a key limitation of the research is the lack of data on how well men in the study adhered to their diabetes treatment. Nevertheless, “clinical guidance is needed to help couples planning pregnancy weigh the risks and benefits of paternal metformin use relative to other medications.”

The researchers received funding from the National Institutes of Health and the Centers for Disease Control and Prevention.

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

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

Before working to create standards for electronic prior authorization, the entire process itself needs some work.

That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”

According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.

In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”

AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.

Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.

Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
 

AHA: Most common prior auth means are phones, fax

The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”

The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.

To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.

In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.

The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.

Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.

In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”

The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”

The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”

In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”

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

Children prenatally exposed to opioids alone have an increased risk of attention-deficit/hyperactivity disorder (ADHD), but interactions between opioids and both cannabis use and alcohol use were linked to varying levels of ADHD risk as well, according to findings published March 11 in JAMA Network Open.

While many prenatal exposure studies examine associations with one substance, the results of this case-control study “suggest that it is important to consider prenatal exposure to multiple substances and the interactions between these substances when counseling women regarding substance use during pregnancy,” wrote Henri M. Garrison-Desany of the Johns Hopkins University, Baltimore, and colleagues.

Using data from children in the prospective Boston Birth Cohort between 1998 and 2019, the researchers did a secondary analysis on the 3,138 children (50.4% of whom were male) with at least 2 years of follow-up, excluding children from multiple-gestation pregnancies, in vitro fertilization pregnancies, and deliveries involving major maternal trauma or major chromosomal anomalies. Mothers answered a questionnaire within 24-72 hours of delivery regarding their demographics, substance use, pregnancy history, and health status. Among the mothers, 58.6% were Black, 22.3% were Hispanic, 7.2% were White, 1.5% were Asian, and 10.4% were other races/ethnicities.

The children’s electronic medical records were used to identify those with ADHD diagnoses. The researchers did not assess prescription opioid exposure during pregnancy, but they based opioid exposure on mothers’ reports of recreationally using heroin or oxycodone, mothers’ reports of receiving methadone treatment, or a newborn diagnosis of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome.

Just under a quarter of the women (24.2%) reported using at least one substance during pregnancy. After tobacco smoking (18.5%), the next most reported substances were alcohol (8.1%), cannabis (3.9%), and opioids (1.9%). With a median 12 years of follow-up, 15.5% of the children had been diagnosed with ADHD, most of whom (71.6%) were male.

Before considering interaction of different substances, children exposed to opioids had a little over twice the risk of ADHD (hazard ratio [HR], 2.19) compared to those with no prenatal substance exposure. Although neither cannabis nor alcohol was independently associated with ADHD, smoking had a 40% increased risk, and researchers found a 21% increase in risk of ADHD with each additional substance mothers used during pregnancy. The researchers had adjusted these findings for maternal age, race/ethnicity, marital status, educational level, annual household income, parity, number of perinatal visits, and general stress during pregnancy, based on a structured interview.

When the researchers considered all the substances together, opioid exposure increased risk of ADHD by 60% (HR, 1.6), opioids with cannabis increased risk by 42%, opioids with alcohol increased risk by 15%, and opioids with smoking increased risk by 17%.

”Our findings suggest opioids may interact with other substances (including cannabis), which may be particularly deleterious,” the researchers reported. “It is not clear whether this interaction is owing to biological or environmental factors, such as whether individuals with illicit polysubstance use are more likely to use more substances or whether they have other characteristics that may impact child development.”

The authors noted that cannabis exposure has been linked to other neurodevelopmental outcomes, including reduced executive and motor function in infants. ”Notably, although we did not find a significant independent association between cannabis exposure and ADHD, children exposed to both cannabis and opioids had a 23% greater risk than expected from either exposure individually,” they reported.

The researchers suggest that their findings provide data for considering harm reduction approaches that reduce use of any single substance during pregnancy. “Focusing on the most obviously harmful exposures may be a useful way to reduce the risk of ADHD,” they wrote. “Further work is needed to directly investigate this hypothesis and examine whether reduction in the use of any substance among those with polysubstance use could be acceptable compared with abstinence.”

In an invited commentary, Angela Lupattelli, PhD, and Nhung T. H. Trinh, PhD, both of the department of pharmacy at the University of Oslo, noted the methodological challenges of assessing exposures and associations from multiple different substances during pregnancy.

“First, how can we disentangle the consequences of individual and/or combined substance exposures during pregnancy from the underlying risks?” they asked. In addition to differences in baseline characteristic between those who use opioids or cannabis, Dr. Lupattelli and Dr. Trinh noted that other important unmeasured factors, such as genetics and family environment, may confound the effect size estimates for ADHD.

They also noted the need to consider intensity, dose, duration, and timing of substance use during pregnancy.

“Understanding the longer-term safety of substance use during pregnancy is paramount to inform prevention policy and shape counseling strategies. Observational studies, despite their limitations, are a necessary piece of the puzzle,” they wrote. “However, the study findings should be interpreted with caution, as the use of advanced analytical methods cannot overcome the unavailability of some important confounding factors and exposure information.”

The research was funded by the U.S. Department of Health and Human Services and the National Institutes of Health. The authors had no industry-related disclosures.

Children prenatally exposed to opioids alone have an increased risk of attention-deficit/hyperactivity disorder (ADHD), but interactions between opioids and both cannabis use and alcohol use were linked to varying levels of ADHD risk as well, according to findings published March 11 in JAMA Network Open.

While many prenatal exposure studies examine associations with one substance, the results of this case-control study “suggest that it is important to consider prenatal exposure to multiple substances and the interactions between these substances when counseling women regarding substance use during pregnancy,” wrote Henri M. Garrison-Desany of the Johns Hopkins University, Baltimore, and colleagues.

Using data from children in the prospective Boston Birth Cohort between 1998 and 2019, the researchers did a secondary analysis on the 3,138 children (50.4% of whom were male) with at least 2 years of follow-up, excluding children from multiple-gestation pregnancies, in vitro fertilization pregnancies, and deliveries involving major maternal trauma or major chromosomal anomalies. Mothers answered a questionnaire within 24-72 hours of delivery regarding their demographics, substance use, pregnancy history, and health status. Among the mothers, 58.6% were Black, 22.3% were Hispanic, 7.2% were White, 1.5% were Asian, and 10.4% were other races/ethnicities.

The children’s electronic medical records were used to identify those with ADHD diagnoses. The researchers did not assess prescription opioid exposure during pregnancy, but they based opioid exposure on mothers’ reports of recreationally using heroin or oxycodone, mothers’ reports of receiving methadone treatment, or a newborn diagnosis of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome.

Just under a quarter of the women (24.2%) reported using at least one substance during pregnancy. After tobacco smoking (18.5%), the next most reported substances were alcohol (8.1%), cannabis (3.9%), and opioids (1.9%). With a median 12 years of follow-up, 15.5% of the children had been diagnosed with ADHD, most of whom (71.6%) were male.

Before considering interaction of different substances, children exposed to opioids had a little over twice the risk of ADHD (hazard ratio [HR], 2.19) compared to those with no prenatal substance exposure. Although neither cannabis nor alcohol was independently associated with ADHD, smoking had a 40% increased risk, and researchers found a 21% increase in risk of ADHD with each additional substance mothers used during pregnancy. The researchers had adjusted these findings for maternal age, race/ethnicity, marital status, educational level, annual household income, parity, number of perinatal visits, and general stress during pregnancy, based on a structured interview.

When the researchers considered all the substances together, opioid exposure increased risk of ADHD by 60% (HR, 1.6), opioids with cannabis increased risk by 42%, opioids with alcohol increased risk by 15%, and opioids with smoking increased risk by 17%.

”Our findings suggest opioids may interact with other substances (including cannabis), which may be particularly deleterious,” the researchers reported. “It is not clear whether this interaction is owing to biological or environmental factors, such as whether individuals with illicit polysubstance use are more likely to use more substances or whether they have other characteristics that may impact child development.”

The authors noted that cannabis exposure has been linked to other neurodevelopmental outcomes, including reduced executive and motor function in infants. ”Notably, although we did not find a significant independent association between cannabis exposure and ADHD, children exposed to both cannabis and opioids had a 23% greater risk than expected from either exposure individually,” they reported.

The researchers suggest that their findings provide data for considering harm reduction approaches that reduce use of any single substance during pregnancy. “Focusing on the most obviously harmful exposures may be a useful way to reduce the risk of ADHD,” they wrote. “Further work is needed to directly investigate this hypothesis and examine whether reduction in the use of any substance among those with polysubstance use could be acceptable compared with abstinence.”

In an invited commentary, Angela Lupattelli, PhD, and Nhung T. H. Trinh, PhD, both of the department of pharmacy at the University of Oslo, noted the methodological challenges of assessing exposures and associations from multiple different substances during pregnancy.

“First, how can we disentangle the consequences of individual and/or combined substance exposures during pregnancy from the underlying risks?” they asked. In addition to differences in baseline characteristic between those who use opioids or cannabis, Dr. Lupattelli and Dr. Trinh noted that other important unmeasured factors, such as genetics and family environment, may confound the effect size estimates for ADHD.

They also noted the need to consider intensity, dose, duration, and timing of substance use during pregnancy.

“Understanding the longer-term safety of substance use during pregnancy is paramount to inform prevention policy and shape counseling strategies. Observational studies, despite their limitations, are a necessary piece of the puzzle,” they wrote. “However, the study findings should be interpreted with caution, as the use of advanced analytical methods cannot overcome the unavailability of some important confounding factors and exposure information.”

The research was funded by the U.S. Department of Health and Human Services and the National Institutes of Health. The authors had no industry-related disclosures.

Children prenatally exposed to opioids alone have an increased risk of attention-deficit/hyperactivity disorder (ADHD), but interactions between opioids and both cannabis use and alcohol use were linked to varying levels of ADHD risk as well, according to findings published March 11 in JAMA Network Open.

While many prenatal exposure studies examine associations with one substance, the results of this case-control study “suggest that it is important to consider prenatal exposure to multiple substances and the interactions between these substances when counseling women regarding substance use during pregnancy,” wrote Henri M. Garrison-Desany of the Johns Hopkins University, Baltimore, and colleagues.

Using data from children in the prospective Boston Birth Cohort between 1998 and 2019, the researchers did a secondary analysis on the 3,138 children (50.4% of whom were male) with at least 2 years of follow-up, excluding children from multiple-gestation pregnancies, in vitro fertilization pregnancies, and deliveries involving major maternal trauma or major chromosomal anomalies. Mothers answered a questionnaire within 24-72 hours of delivery regarding their demographics, substance use, pregnancy history, and health status. Among the mothers, 58.6% were Black, 22.3% were Hispanic, 7.2% were White, 1.5% were Asian, and 10.4% were other races/ethnicities.

The children’s electronic medical records were used to identify those with ADHD diagnoses. The researchers did not assess prescription opioid exposure during pregnancy, but they based opioid exposure on mothers’ reports of recreationally using heroin or oxycodone, mothers’ reports of receiving methadone treatment, or a newborn diagnosis of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome.

Just under a quarter of the women (24.2%) reported using at least one substance during pregnancy. After tobacco smoking (18.5%), the next most reported substances were alcohol (8.1%), cannabis (3.9%), and opioids (1.9%). With a median 12 years of follow-up, 15.5% of the children had been diagnosed with ADHD, most of whom (71.6%) were male.

Before considering interaction of different substances, children exposed to opioids had a little over twice the risk of ADHD (hazard ratio [HR], 2.19) compared to those with no prenatal substance exposure. Although neither cannabis nor alcohol was independently associated with ADHD, smoking had a 40% increased risk, and researchers found a 21% increase in risk of ADHD with each additional substance mothers used during pregnancy. The researchers had adjusted these findings for maternal age, race/ethnicity, marital status, educational level, annual household income, parity, number of perinatal visits, and general stress during pregnancy, based on a structured interview.

When the researchers considered all the substances together, opioid exposure increased risk of ADHD by 60% (HR, 1.6), opioids with cannabis increased risk by 42%, opioids with alcohol increased risk by 15%, and opioids with smoking increased risk by 17%.

”Our findings suggest opioids may interact with other substances (including cannabis), which may be particularly deleterious,” the researchers reported. “It is not clear whether this interaction is owing to biological or environmental factors, such as whether individuals with illicit polysubstance use are more likely to use more substances or whether they have other characteristics that may impact child development.”

The authors noted that cannabis exposure has been linked to other neurodevelopmental outcomes, including reduced executive and motor function in infants. ”Notably, although we did not find a significant independent association between cannabis exposure and ADHD, children exposed to both cannabis and opioids had a 23% greater risk than expected from either exposure individually,” they reported.

The researchers suggest that their findings provide data for considering harm reduction approaches that reduce use of any single substance during pregnancy. “Focusing on the most obviously harmful exposures may be a useful way to reduce the risk of ADHD,” they wrote. “Further work is needed to directly investigate this hypothesis and examine whether reduction in the use of any substance among those with polysubstance use could be acceptable compared with abstinence.”

In an invited commentary, Angela Lupattelli, PhD, and Nhung T. H. Trinh, PhD, both of the department of pharmacy at the University of Oslo, noted the methodological challenges of assessing exposures and associations from multiple different substances during pregnancy.

“First, how can we disentangle the consequences of individual and/or combined substance exposures during pregnancy from the underlying risks?” they asked. In addition to differences in baseline characteristic between those who use opioids or cannabis, Dr. Lupattelli and Dr. Trinh noted that other important unmeasured factors, such as genetics and family environment, may confound the effect size estimates for ADHD.

They also noted the need to consider intensity, dose, duration, and timing of substance use during pregnancy.

“Understanding the longer-term safety of substance use during pregnancy is paramount to inform prevention policy and shape counseling strategies. Observational studies, despite their limitations, are a necessary piece of the puzzle,” they wrote. “However, the study findings should be interpreted with caution, as the use of advanced analytical methods cannot overcome the unavailability of some important confounding factors and exposure information.”

The research was funded by the U.S. Department of Health and Human Services and the National Institutes of Health. The authors had no industry-related disclosures.

Despite the original intent of permanent contraception, tubal sterilization regret is experienced by 2%-26% of women as demonstrated by the United States Collaborative Review of Sterilization “CREST” 14-year study (Obstet Gynecol. 1999 Jun;93[6]:889-95). Regret appears to be higher in the United States than Europe and in resource-limited countries and is more common in women who are less than age 30, African-American, and unmarried. Nevertheless, requests for tubal reversal are estimated to be between 1% and 4% (Contraception. 1981 Jun;23[6]:579-89). The alternative option for fertility is in vitro fertilization (IVF) and this month’s column considers the pros and cons of both methods.

The procedure of tubal reanastomosis involves removing abnormal tissue and reapproximating the healthy tubal segments with attention to minimize adhesion formation through continued gentle irrigation. The surgery involves microsuturing using 6-0 to 10-0 sutures. Tubal patency can be confirmed during the procedure and with a subsequent hysterosalpingogram. While time from sterilization and the type of sterilization technique are factors that may influence the success rate of tubal reanastomosis, the age of the woman is the most predictive for pregnancy outcome.

In the original CREST study, the risk of ectopic pregnancy following tubal reanastomosis was contingent on the method of sterilization: Bipolar electrosurgery resulted in the highest probability of ectopic pregnancy (17.1 per 1,000 procedures at 10 years after permanent contraception), while postpartum partial salpingectomy resulted in the lowest (1.5 per 1,000 procedures at 10 years after permanent contraception) (N Engl J Med. 1997;336[11]:762). Comparatively, the ectopic pregnancy rate during an IVF cycle was 1.9% for pregnancies from transfers of fresh cleavage embryo, followed by transfers of frozen cleavage embryo (1.7%), transfers of fresh blastocyst (1.3%), and transfers of frozen blastocyst (0.8%) (Hum Reprod. 2015;30[9]:2048-54).

Reports vary regarding pregnancy rates from tubal reanastomosis. Prior use of rings and clips for sterilization appear to yield the highest outcomes as opposed to the use of electrocautery. In one large Canadian cohort study of over 300,000 women, those aged 15-30 years, 30-33 years, and 34-49 years had a conception rate of 73%, 64%, and 46%, respectively (Obstet Gynecol. 2003;101[4]:677-84). Most pregnancies were within 2 years after reversal and 48% of women achieved a delivery. Of interest, 23% of patients subsequently underwent another sterilization.

An Australian study of nearly 2,000 women found an overall cumulative live-delivery rate of 20% within the first year after reversal, 40% at 2 years, 51% at 5 years, and 52% at 10 years. As expected, the 5-year cumulative live-delivery rate was significantly lower in women who were aged 40-44 years (26%), compared with younger women. For all women below age 40 years, the live-delivery rate was approximately 50% within 5 years after tubal reanastomosis, while the rate halves after the age of 40 (Fertil Steril. 2015 Oct;104[4]:921-6).

To compare tubal reanastomosis with IVF, a retrospective cohort study of 163 patients demonstrated the cumulative delivery rate over 72 months was comparable for IVF vs. sterilization reversal (52% vs. 60%). The only significant difference was in a subset of patients aged <37 years (52% after IVF and 72% after reversal) and the lower cost of surgery. The authors advocated laparoscopic sterilization reversal in women younger than 37 years who have ≥4 cm of residual tube with IVF as the better alternative for all other women (Hum Reprod. 2007;22[10]:2660).

Indeed, tubal length is another important factor in successful reversal. The pregnancy rate after tubal anastomosis is 75% in women with tubal length of 4 cm or more, but only 19% in those with shorter tubes (Fertil Steril. 1987;48[1]:13-7). The literature does suggest equivalent pregnancy rates after laparoscopic tubal anastomosis and conventional microsurgical anastomosis. Although the laparoscopic approach may be more economical, it is more demanding technically than an open microsurgical procedure.

Tubal reanastomosis can also be performed using robot-assisted laparoscopy. In preliminary studies, robotic surgery appears to have a similar success rate and a shorter recovery time, but longer operative times and higher costs (Obstet Gynecol. 2007;109[6]:1375; Fertil Steril. 2008;90[4]:1175).

To educate women on the success of IVF based on individual characteristics, a valuable tool to approximate the cumulative outcome for a live birth following one cycle of IVF is offered by the Society for Assisted Reproductive Technology. To clarify, a cycle of IVF consists of one egg retrieval and the ultimate transfer of all embryos produced, i.e., fresh and frozen. The website also includes estimations of success following a second and third IVF cycle.

The woman’s age is a significant predictor of IVF success. Ovarian aging is currently best measured by combining chronologic age, antral follicle count (AFC) by transvaginal pelvic ultrasound, and serum anti-Müllerian hormone (AMH). Natural fecundity begins to decline, on average, above age 32-33 years. An AFC less than 11 reflects diminished ovarian reserve (DOR) and less than 6 is severe. AMH levels below 1.6 ng/mL have been shown to reduce the number of eggs retrieved with IVF, while levels below 0.4 ng/mL are very low. Very low AMH levels negatively affect the outcome of IVF cycles as demonstrated in the SART data study from a population of women with a mean age of 39.4 years: Cycle cancellation was 54%; of all retrieval attempts, no oocytes were obtained in 5.4%, and no embryo transfer occurred in 25.1% of cycles; the live birth rate per embryo transfer was 20.5% (9.5% per cycle start and 16.3% per retrieval) from a mean age of 36.8 years (Fertil Steril. 2016 Feb;105[2]:385-93.e3). The predictive ability of AMH on the live birth rate from IVF cycles was also shown in a study of over 85,000 women (Fertil Steril. 2018;109:258-65).

While low AMH has been shown to lessen a successful outcome from IVF, there appears to be no difference in natural pregnancy rates in women aged 30-44 years irrespective of AMH levels (JAMA. 2017;318[14]:1367-76). Of importance, the use of AMH in a population at low risk for DOR will yield a larger number of false-positive results (i.e., characterizing a woman as DOR when in fact she has normal ovarian reserve). Further, users of hormonal contraceptives have a 25.2% lower mean AMH level than nonusers.

When a patient is considering tubal reanastomosis vs. IVF, a useful acronym to remember is to check “AGE” – the A is for AMH because severely diminished ovarian reserve will reduce success with IVF as shown by the SART calculator; the G represents guy, i.e., ensuring a reasonably normal sperm analysis; and E stands for eggs representing ovulation function. In a woman who is anovulatory and who will require fertility medication, it would be reasonable to consider IVF given the need for ovarian stimulation. As in females, advanced paternal age has demonstrated a decline in fertility and sperm analysis parameters. Men above age 45 take approximately five times as long to achieve a pregnancy, compared with men less than 25 years of age. Further, there is evidence for advanced paternal age increasing risk of miscarriage, preterm birth, and birth defects. Men older than 40-45 years have twice the risk of an autistic child and five times the risk of having a child with schizophrenia (Transl Psychiatry 2017;7: e1019; Am J Psychiatry. 2002;159:1528-33).

To conclude, the data support consideration for sterilization reversal in women less than age 37 years with more than 4 cm of residual functional fallopian tube and the prior use of rings or clip sterilization. In other women, IVF may be the better option, particularly when ovulation dysfunction and/or male factor is present. IVF also offers the advantage of maintaining contraception and gender determination. However, given that AMH does not appear to reduce natural fertility, unlike during its effect during an IVF cycle, the option of tubal reversal may be more favorable in women with severe DOR.

Dr. Trolice is director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Despite the original intent of permanent contraception, tubal sterilization regret is experienced by 2%-26% of women as demonstrated by the United States Collaborative Review of Sterilization “CREST” 14-year study (Obstet Gynecol. 1999 Jun;93[6]:889-95). Regret appears to be higher in the United States than Europe and in resource-limited countries and is more common in women who are less than age 30, African-American, and unmarried. Nevertheless, requests for tubal reversal are estimated to be between 1% and 4% (Contraception. 1981 Jun;23[6]:579-89). The alternative option for fertility is in vitro fertilization (IVF) and this month’s column considers the pros and cons of both methods.

The procedure of tubal reanastomosis involves removing abnormal tissue and reapproximating the healthy tubal segments with attention to minimize adhesion formation through continued gentle irrigation. The surgery involves microsuturing using 6-0 to 10-0 sutures. Tubal patency can be confirmed during the procedure and with a subsequent hysterosalpingogram. While time from sterilization and the type of sterilization technique are factors that may influence the success rate of tubal reanastomosis, the age of the woman is the most predictive for pregnancy outcome.

In the original CREST study, the risk of ectopic pregnancy following tubal reanastomosis was contingent on the method of sterilization: Bipolar electrosurgery resulted in the highest probability of ectopic pregnancy (17.1 per 1,000 procedures at 10 years after permanent contraception), while postpartum partial salpingectomy resulted in the lowest (1.5 per 1,000 procedures at 10 years after permanent contraception) (N Engl J Med. 1997;336[11]:762). Comparatively, the ectopic pregnancy rate during an IVF cycle was 1.9% for pregnancies from transfers of fresh cleavage embryo, followed by transfers of frozen cleavage embryo (1.7%), transfers of fresh blastocyst (1.3%), and transfers of frozen blastocyst (0.8%) (Hum Reprod. 2015;30[9]:2048-54).

Reports vary regarding pregnancy rates from tubal reanastomosis. Prior use of rings and clips for sterilization appear to yield the highest outcomes as opposed to the use of electrocautery. In one large Canadian cohort study of over 300,000 women, those aged 15-30 years, 30-33 years, and 34-49 years had a conception rate of 73%, 64%, and 46%, respectively (Obstet Gynecol. 2003;101[4]:677-84). Most pregnancies were within 2 years after reversal and 48% of women achieved a delivery. Of interest, 23% of patients subsequently underwent another sterilization.

An Australian study of nearly 2,000 women found an overall cumulative live-delivery rate of 20% within the first year after reversal, 40% at 2 years, 51% at 5 years, and 52% at 10 years. As expected, the 5-year cumulative live-delivery rate was significantly lower in women who were aged 40-44 years (26%), compared with younger women. For all women below age 40 years, the live-delivery rate was approximately 50% within 5 years after tubal reanastomosis, while the rate halves after the age of 40 (Fertil Steril. 2015 Oct;104[4]:921-6).

To compare tubal reanastomosis with IVF, a retrospective cohort study of 163 patients demonstrated the cumulative delivery rate over 72 months was comparable for IVF vs. sterilization reversal (52% vs. 60%). The only significant difference was in a subset of patients aged <37 years (52% after IVF and 72% after reversal) and the lower cost of surgery. The authors advocated laparoscopic sterilization reversal in women younger than 37 years who have ≥4 cm of residual tube with IVF as the better alternative for all other women (Hum Reprod. 2007;22[10]:2660).

Indeed, tubal length is another important factor in successful reversal. The pregnancy rate after tubal anastomosis is 75% in women with tubal length of 4 cm or more, but only 19% in those with shorter tubes (Fertil Steril. 1987;48[1]:13-7). The literature does suggest equivalent pregnancy rates after laparoscopic tubal anastomosis and conventional microsurgical anastomosis. Although the laparoscopic approach may be more economical, it is more demanding technically than an open microsurgical procedure.

Tubal reanastomosis can also be performed using robot-assisted laparoscopy. In preliminary studies, robotic surgery appears to have a similar success rate and a shorter recovery time, but longer operative times and higher costs (Obstet Gynecol. 2007;109[6]:1375; Fertil Steril. 2008;90[4]:1175).

To educate women on the success of IVF based on individual characteristics, a valuable tool to approximate the cumulative outcome for a live birth following one cycle of IVF is offered by the Society for Assisted Reproductive Technology. To clarify, a cycle of IVF consists of one egg retrieval and the ultimate transfer of all embryos produced, i.e., fresh and frozen. The website also includes estimations of success following a second and third IVF cycle.

The woman’s age is a significant predictor of IVF success. Ovarian aging is currently best measured by combining chronologic age, antral follicle count (AFC) by transvaginal pelvic ultrasound, and serum anti-Müllerian hormone (AMH). Natural fecundity begins to decline, on average, above age 32-33 years. An AFC less than 11 reflects diminished ovarian reserve (DOR) and less than 6 is severe. AMH levels below 1.6 ng/mL have been shown to reduce the number of eggs retrieved with IVF, while levels below 0.4 ng/mL are very low. Very low AMH levels negatively affect the outcome of IVF cycles as demonstrated in the SART data study from a population of women with a mean age of 39.4 years: Cycle cancellation was 54%; of all retrieval attempts, no oocytes were obtained in 5.4%, and no embryo transfer occurred in 25.1% of cycles; the live birth rate per embryo transfer was 20.5% (9.5% per cycle start and 16.3% per retrieval) from a mean age of 36.8 years (Fertil Steril. 2016 Feb;105[2]:385-93.e3). The predictive ability of AMH on the live birth rate from IVF cycles was also shown in a study of over 85,000 women (Fertil Steril. 2018;109:258-65).

While low AMH has been shown to lessen a successful outcome from IVF, there appears to be no difference in natural pregnancy rates in women aged 30-44 years irrespective of AMH levels (JAMA. 2017;318[14]:1367-76). Of importance, the use of AMH in a population at low risk for DOR will yield a larger number of false-positive results (i.e., characterizing a woman as DOR when in fact she has normal ovarian reserve). Further, users of hormonal contraceptives have a 25.2% lower mean AMH level than nonusers.

When a patient is considering tubal reanastomosis vs. IVF, a useful acronym to remember is to check “AGE” – the A is for AMH because severely diminished ovarian reserve will reduce success with IVF as shown by the SART calculator; the G represents guy, i.e., ensuring a reasonably normal sperm analysis; and E stands for eggs representing ovulation function. In a woman who is anovulatory and who will require fertility medication, it would be reasonable to consider IVF given the need for ovarian stimulation. As in females, advanced paternal age has demonstrated a decline in fertility and sperm analysis parameters. Men above age 45 take approximately five times as long to achieve a pregnancy, compared with men less than 25 years of age. Further, there is evidence for advanced paternal age increasing risk of miscarriage, preterm birth, and birth defects. Men older than 40-45 years have twice the risk of an autistic child and five times the risk of having a child with schizophrenia (Transl Psychiatry 2017;7: e1019; Am J Psychiatry. 2002;159:1528-33).

To conclude, the data support consideration for sterilization reversal in women less than age 37 years with more than 4 cm of residual functional fallopian tube and the prior use of rings or clip sterilization. In other women, IVF may be the better option, particularly when ovulation dysfunction and/or male factor is present. IVF also offers the advantage of maintaining contraception and gender determination. However, given that AMH does not appear to reduce natural fertility, unlike during its effect during an IVF cycle, the option of tubal reversal may be more favorable in women with severe DOR.

Dr. Trolice is director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Despite the original intent of permanent contraception, tubal sterilization regret is experienced by 2%-26% of women as demonstrated by the United States Collaborative Review of Sterilization “CREST” 14-year study (Obstet Gynecol. 1999 Jun;93[6]:889-95). Regret appears to be higher in the United States than Europe and in resource-limited countries and is more common in women who are less than age 30, African-American, and unmarried. Nevertheless, requests for tubal reversal are estimated to be between 1% and 4% (Contraception. 1981 Jun;23[6]:579-89). The alternative option for fertility is in vitro fertilization (IVF) and this month’s column considers the pros and cons of both methods.

The procedure of tubal reanastomosis involves removing abnormal tissue and reapproximating the healthy tubal segments with attention to minimize adhesion formation through continued gentle irrigation. The surgery involves microsuturing using 6-0 to 10-0 sutures. Tubal patency can be confirmed during the procedure and with a subsequent hysterosalpingogram. While time from sterilization and the type of sterilization technique are factors that may influence the success rate of tubal reanastomosis, the age of the woman is the most predictive for pregnancy outcome.

In the original CREST study, the risk of ectopic pregnancy following tubal reanastomosis was contingent on the method of sterilization: Bipolar electrosurgery resulted in the highest probability of ectopic pregnancy (17.1 per 1,000 procedures at 10 years after permanent contraception), while postpartum partial salpingectomy resulted in the lowest (1.5 per 1,000 procedures at 10 years after permanent contraception) (N Engl J Med. 1997;336[11]:762). Comparatively, the ectopic pregnancy rate during an IVF cycle was 1.9% for pregnancies from transfers of fresh cleavage embryo, followed by transfers of frozen cleavage embryo (1.7%), transfers of fresh blastocyst (1.3%), and transfers of frozen blastocyst (0.8%) (Hum Reprod. 2015;30[9]:2048-54).

Reports vary regarding pregnancy rates from tubal reanastomosis. Prior use of rings and clips for sterilization appear to yield the highest outcomes as opposed to the use of electrocautery. In one large Canadian cohort study of over 300,000 women, those aged 15-30 years, 30-33 years, and 34-49 years had a conception rate of 73%, 64%, and 46%, respectively (Obstet Gynecol. 2003;101[4]:677-84). Most pregnancies were within 2 years after reversal and 48% of women achieved a delivery. Of interest, 23% of patients subsequently underwent another sterilization.

An Australian study of nearly 2,000 women found an overall cumulative live-delivery rate of 20% within the first year after reversal, 40% at 2 years, 51% at 5 years, and 52% at 10 years. As expected, the 5-year cumulative live-delivery rate was significantly lower in women who were aged 40-44 years (26%), compared with younger women. For all women below age 40 years, the live-delivery rate was approximately 50% within 5 years after tubal reanastomosis, while the rate halves after the age of 40 (Fertil Steril. 2015 Oct;104[4]:921-6).

To compare tubal reanastomosis with IVF, a retrospective cohort study of 163 patients demonstrated the cumulative delivery rate over 72 months was comparable for IVF vs. sterilization reversal (52% vs. 60%). The only significant difference was in a subset of patients aged <37 years (52% after IVF and 72% after reversal) and the lower cost of surgery. The authors advocated laparoscopic sterilization reversal in women younger than 37 years who have ≥4 cm of residual tube with IVF as the better alternative for all other women (Hum Reprod. 2007;22[10]:2660).

Indeed, tubal length is another important factor in successful reversal. The pregnancy rate after tubal anastomosis is 75% in women with tubal length of 4 cm or more, but only 19% in those with shorter tubes (Fertil Steril. 1987;48[1]:13-7). The literature does suggest equivalent pregnancy rates after laparoscopic tubal anastomosis and conventional microsurgical anastomosis. Although the laparoscopic approach may be more economical, it is more demanding technically than an open microsurgical procedure.

Tubal reanastomosis can also be performed using robot-assisted laparoscopy. In preliminary studies, robotic surgery appears to have a similar success rate and a shorter recovery time, but longer operative times and higher costs (Obstet Gynecol. 2007;109[6]:1375; Fertil Steril. 2008;90[4]:1175).

To educate women on the success of IVF based on individual characteristics, a valuable tool to approximate the cumulative outcome for a live birth following one cycle of IVF is offered by the Society for Assisted Reproductive Technology. To clarify, a cycle of IVF consists of one egg retrieval and the ultimate transfer of all embryos produced, i.e., fresh and frozen. The website also includes estimations of success following a second and third IVF cycle.

The woman’s age is a significant predictor of IVF success. Ovarian aging is currently best measured by combining chronologic age, antral follicle count (AFC) by transvaginal pelvic ultrasound, and serum anti-Müllerian hormone (AMH). Natural fecundity begins to decline, on average, above age 32-33 years. An AFC less than 11 reflects diminished ovarian reserve (DOR) and less than 6 is severe. AMH levels below 1.6 ng/mL have been shown to reduce the number of eggs retrieved with IVF, while levels below 0.4 ng/mL are very low. Very low AMH levels negatively affect the outcome of IVF cycles as demonstrated in the SART data study from a population of women with a mean age of 39.4 years: Cycle cancellation was 54%; of all retrieval attempts, no oocytes were obtained in 5.4%, and no embryo transfer occurred in 25.1% of cycles; the live birth rate per embryo transfer was 20.5% (9.5% per cycle start and 16.3% per retrieval) from a mean age of 36.8 years (Fertil Steril. 2016 Feb;105[2]:385-93.e3). The predictive ability of AMH on the live birth rate from IVF cycles was also shown in a study of over 85,000 women (Fertil Steril. 2018;109:258-65).

While low AMH has been shown to lessen a successful outcome from IVF, there appears to be no difference in natural pregnancy rates in women aged 30-44 years irrespective of AMH levels (JAMA. 2017;318[14]:1367-76). Of importance, the use of AMH in a population at low risk for DOR will yield a larger number of false-positive results (i.e., characterizing a woman as DOR when in fact she has normal ovarian reserve). Further, users of hormonal contraceptives have a 25.2% lower mean AMH level than nonusers.

When a patient is considering tubal reanastomosis vs. IVF, a useful acronym to remember is to check “AGE” – the A is for AMH because severely diminished ovarian reserve will reduce success with IVF as shown by the SART calculator; the G represents guy, i.e., ensuring a reasonably normal sperm analysis; and E stands for eggs representing ovulation function. In a woman who is anovulatory and who will require fertility medication, it would be reasonable to consider IVF given the need for ovarian stimulation. As in females, advanced paternal age has demonstrated a decline in fertility and sperm analysis parameters. Men above age 45 take approximately five times as long to achieve a pregnancy, compared with men less than 25 years of age. Further, there is evidence for advanced paternal age increasing risk of miscarriage, preterm birth, and birth defects. Men older than 40-45 years have twice the risk of an autistic child and five times the risk of having a child with schizophrenia (Transl Psychiatry 2017;7: e1019; Am J Psychiatry. 2002;159:1528-33).

To conclude, the data support consideration for sterilization reversal in women less than age 37 years with more than 4 cm of residual functional fallopian tube and the prior use of rings or clip sterilization. In other women, IVF may be the better option, particularly when ovulation dysfunction and/or male factor is present. IVF also offers the advantage of maintaining contraception and gender determination. However, given that AMH does not appear to reduce natural fertility, unlike during its effect during an IVF cycle, the option of tubal reversal may be more favorable in women with severe DOR.

Dr. Trolice is director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

 Further support for the benefits of regular exercise in reducing severe COVID-19 outcomes has come from a large study, the first to directly measure physical activity in its participants.

Researchers identified 65,361 members of a South African private health plan who had a COVID-19 diagnosis from March 2020 to June 2021 and matched them with physical activity data during the 2 years prior to the country’s March 2020 lockdown captured by smart devices, and clocked gym attendance and mass event participation in a voluntary healthy lifestyle behavior program linked to the insurer.

UberImages/iStock/Getty Images

In all, 20.4% of participants had engaged in low levels of at least moderate-intensity physical activity per week (0-59 minutes), 34.5% in moderate levels (60-149 minutes), and 45.1% in high levels (150 minutes or more).

Overall, 11.1% were hospitalized as a result of COVID-19, 2.4% were admitted to the ICU, 1.3% required a ventilator, and 1.6% died.

As reported in the British Journal of Sports Medicine, analyses adjusted for demographic and other risk factors showed that, with COVID-19 infection, people with high versus low physical activity had a 34% lower risk for hospitalization (risk ratio, 0.66; 95% confidence interval, 0.63-0.70), a 41% lower risk for ICU admission (RR, 0.59; 95% CI, 0.52-0.66), a 45% lower risk of requiring ventilation (RR, 0.55; 95% CI, 0.47-0.64), and a 42% lower risk for death (RR, 0.58; 95% CI, 0.50-0.68).

Even moderate physical exercise, below the recommended guidelines of at least 150 minutes per week, was associated with several benefits, such as a 13% lower risk for hospitalization (RR, 0.87; 95% CI, 0.82-0.91), a 20% lower risk for ICU admission (RR, 0.80; 95% CI, 0.71-0.89), a 27% lower risk of requiring ventilation (RR, 0.73; 95% CI, 0.62-0.84), and a21% lower risk for death (RR, 0.79; 95% CI, 0.69-0.91).

“Should we come across further waves of this pandemic, our advice from a medical point of view should be to promote and facilitate exercise,” senior author Jon Patricios, MD, Wits Sport and Health, University of the Witwatersrand, Johannesburg, South Africa, said in an interview. “The likelihood is that exercise and vaccination are going to be the two most significant interventions in terms of helping to offload the health care system rather than face the catastrophic events endured a year or so ago.”

The study showed that males are at greater risk than females for severe COVID-19 outcomes, as were patients with essential hypertension, diabetes, and chronic renal disease.

It also suggests that the protective benefit of exercise extends to HIV-positive patients and those with rheumatoid arthritis, two groups previously not evaluated, the authors noted.

The results are comparable with previous reports of self-reported exercise and COVID-19 from the United States and South Korea, although the effect of even moderate exercise was more significant, possibly due to the use of direct measures of exercise rather than self-report, Dr. Patricios suggested.

Previous data suggest that regular physical activity may protect against many viral infections including influenza, rhinovirus, and the reactivation of latent herpes viruses, he noted. However, emerging evidence also points to significant decreases in physical activity during the pandemic.

“Regular physical activity should be a message that is strongly, strongly advocated for, particularly in less well-developed countries where we don’t have access or the resources to afford pharmacological interventions in many of these scenarios,” Dr. Patricios said. “It’s frustrating that the message is not driven strongly enough. It should be part of every government’s agenda.”

The cohort all being members of a medical insurance plan could imply some selection bias based on affordability and limit generalizability of the results, the authors noted. Other limitations include a lack of data on sociodemographic criteria such as education, income, and race, as well as behavioral risk factors such as smoking and diet.

Dr. Patricios and one coauthor are editors of the British Journal of Sports Medicine. Several coauthors are employees of Discovery Health, Johannesburg.

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

 Further support for the benefits of regular exercise in reducing severe COVID-19 outcomes has come from a large study, the first to directly measure physical activity in its participants.

Researchers identified 65,361 members of a South African private health plan who had a COVID-19 diagnosis from March 2020 to June 2021 and matched them with physical activity data during the 2 years prior to the country’s March 2020 lockdown captured by smart devices, and clocked gym attendance and mass event participation in a voluntary healthy lifestyle behavior program linked to the insurer.

UberImages/iStock/Getty Images

In all, 20.4% of participants had engaged in low levels of at least moderate-intensity physical activity per week (0-59 minutes), 34.5% in moderate levels (60-149 minutes), and 45.1% in high levels (150 minutes or more).

Overall, 11.1% were hospitalized as a result of COVID-19, 2.4% were admitted to the ICU, 1.3% required a ventilator, and 1.6% died.

As reported in the British Journal of Sports Medicine, analyses adjusted for demographic and other risk factors showed that, with COVID-19 infection, people with high versus low physical activity had a 34% lower risk for hospitalization (risk ratio, 0.66; 95% confidence interval, 0.63-0.70), a 41% lower risk for ICU admission (RR, 0.59; 95% CI, 0.52-0.66), a 45% lower risk of requiring ventilation (RR, 0.55; 95% CI, 0.47-0.64), and a 42% lower risk for death (RR, 0.58; 95% CI, 0.50-0.68).

Even moderate physical exercise, below the recommended guidelines of at least 150 minutes per week, was associated with several benefits, such as a 13% lower risk for hospitalization (RR, 0.87; 95% CI, 0.82-0.91), a 20% lower risk for ICU admission (RR, 0.80; 95% CI, 0.71-0.89), a 27% lower risk of requiring ventilation (RR, 0.73; 95% CI, 0.62-0.84), and a21% lower risk for death (RR, 0.79; 95% CI, 0.69-0.91).

“Should we come across further waves of this pandemic, our advice from a medical point of view should be to promote and facilitate exercise,” senior author Jon Patricios, MD, Wits Sport and Health, University of the Witwatersrand, Johannesburg, South Africa, said in an interview. “The likelihood is that exercise and vaccination are going to be the two most significant interventions in terms of helping to offload the health care system rather than face the catastrophic events endured a year or so ago.”

The study showed that males are at greater risk than females for severe COVID-19 outcomes, as were patients with essential hypertension, diabetes, and chronic renal disease.

It also suggests that the protective benefit of exercise extends to HIV-positive patients and those with rheumatoid arthritis, two groups previously not evaluated, the authors noted.

The results are comparable with previous reports of self-reported exercise and COVID-19 from the United States and South Korea, although the effect of even moderate exercise was more significant, possibly due to the use of direct measures of exercise rather than self-report, Dr. Patricios suggested.

Previous data suggest that regular physical activity may protect against many viral infections including influenza, rhinovirus, and the reactivation of latent herpes viruses, he noted. However, emerging evidence also points to significant decreases in physical activity during the pandemic.

“Regular physical activity should be a message that is strongly, strongly advocated for, particularly in less well-developed countries where we don’t have access or the resources to afford pharmacological interventions in many of these scenarios,” Dr. Patricios said. “It’s frustrating that the message is not driven strongly enough. It should be part of every government’s agenda.”

The cohort all being members of a medical insurance plan could imply some selection bias based on affordability and limit generalizability of the results, the authors noted. Other limitations include a lack of data on sociodemographic criteria such as education, income, and race, as well as behavioral risk factors such as smoking and diet.

Dr. Patricios and one coauthor are editors of the British Journal of Sports Medicine. Several coauthors are employees of Discovery Health, Johannesburg.

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

 Further support for the benefits of regular exercise in reducing severe COVID-19 outcomes has come from a large study, the first to directly measure physical activity in its participants.

Researchers identified 65,361 members of a South African private health plan who had a COVID-19 diagnosis from March 2020 to June 2021 and matched them with physical activity data during the 2 years prior to the country’s March 2020 lockdown captured by smart devices, and clocked gym attendance and mass event participation in a voluntary healthy lifestyle behavior program linked to the insurer.

UberImages/iStock/Getty Images

In all, 20.4% of participants had engaged in low levels of at least moderate-intensity physical activity per week (0-59 minutes), 34.5% in moderate levels (60-149 minutes), and 45.1% in high levels (150 minutes or more).

Overall, 11.1% were hospitalized as a result of COVID-19, 2.4% were admitted to the ICU, 1.3% required a ventilator, and 1.6% died.

As reported in the British Journal of Sports Medicine, analyses adjusted for demographic and other risk factors showed that, with COVID-19 infection, people with high versus low physical activity had a 34% lower risk for hospitalization (risk ratio, 0.66; 95% confidence interval, 0.63-0.70), a 41% lower risk for ICU admission (RR, 0.59; 95% CI, 0.52-0.66), a 45% lower risk of requiring ventilation (RR, 0.55; 95% CI, 0.47-0.64), and a 42% lower risk for death (RR, 0.58; 95% CI, 0.50-0.68).

Even moderate physical exercise, below the recommended guidelines of at least 150 minutes per week, was associated with several benefits, such as a 13% lower risk for hospitalization (RR, 0.87; 95% CI, 0.82-0.91), a 20% lower risk for ICU admission (RR, 0.80; 95% CI, 0.71-0.89), a 27% lower risk of requiring ventilation (RR, 0.73; 95% CI, 0.62-0.84), and a21% lower risk for death (RR, 0.79; 95% CI, 0.69-0.91).

“Should we come across further waves of this pandemic, our advice from a medical point of view should be to promote and facilitate exercise,” senior author Jon Patricios, MD, Wits Sport and Health, University of the Witwatersrand, Johannesburg, South Africa, said in an interview. “The likelihood is that exercise and vaccination are going to be the two most significant interventions in terms of helping to offload the health care system rather than face the catastrophic events endured a year or so ago.”

The study showed that males are at greater risk than females for severe COVID-19 outcomes, as were patients with essential hypertension, diabetes, and chronic renal disease.

It also suggests that the protective benefit of exercise extends to HIV-positive patients and those with rheumatoid arthritis, two groups previously not evaluated, the authors noted.

The results are comparable with previous reports of self-reported exercise and COVID-19 from the United States and South Korea, although the effect of even moderate exercise was more significant, possibly due to the use of direct measures of exercise rather than self-report, Dr. Patricios suggested.

Previous data suggest that regular physical activity may protect against many viral infections including influenza, rhinovirus, and the reactivation of latent herpes viruses, he noted. However, emerging evidence also points to significant decreases in physical activity during the pandemic.

“Regular physical activity should be a message that is strongly, strongly advocated for, particularly in less well-developed countries where we don’t have access or the resources to afford pharmacological interventions in many of these scenarios,” Dr. Patricios said. “It’s frustrating that the message is not driven strongly enough. It should be part of every government’s agenda.”

The cohort all being members of a medical insurance plan could imply some selection bias based on affordability and limit generalizability of the results, the authors noted. Other limitations include a lack of data on sociodemographic criteria such as education, income, and race, as well as behavioral risk factors such as smoking and diet.

Dr. Patricios and one coauthor are editors of the British Journal of Sports Medicine. Several coauthors are employees of Discovery Health, Johannesburg.

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

Thank Goodness it’s Monday? Sincerely yours, #hustle. 

The COVID-19 pandemic has given us the opportunity to reevaluate what we believe is important and valuable in our life. For some, it’s the opportunity to perform meaningful work; for others, it’s increased financial compensation; and, for the remaining, it may be autonomy (e.g., control over their time). One example of where this mindset has manifested has been in the Great Resignation. 

The Great Resignation refers to the significant increase in resignations that was recorded in April 2021. Resignation rates tend to be higher in fields with high turnover rates (e.g., health care, tech) as a result of increased demand and burnout. Although hustle culture has been an ongoing trend for the last few years, the pandemic has given somewhat of a reality check of the future. 

Hustle culture refers to the embracing of work as a lifestyle such that it takes over other important aspects of your life – in other words, when work-life balance becomes work-work (im)balance. It has also been aptly referred to as burnout culture or grind culture. It’s a bit ironic or counterintuitive to think that stopping work means increased productivity – but it’s true. 

During my undergraduate years, I was always hustling – there wasn’t a moment where I wasn’t studying, doing research, training for my sport, or thinking about how I could do better and be better. It was all about working 24/7 – an illusion to think I was being productive. Now don’t get me wrong, I think the time and effort I invested during those years paid off. However, it also resulted in a sense of dissatisfaction; that is, dissatisfaction that I didn’t explore other potential paths, that I didn’t have the courage to try new things and to be okay with making mistakes. I had extremely narrow tunnel vision because my one and only goal was to go to medical school. 

However, after entering graduate school and actually taking the time to explore other options and career pathways in health, as well as realize that nontraditional pathways are becoming more and more conventional, there is a sense of relief that “failure” is not about changing paths or making mistakes. 

The part of hustle culture that has me hung up is being able to take the time to reflect whether this is what you truly want. I still believe in the value of hard work but I also believe in the value of meaningful and efficient work while also taking the time to reflect. 

The pandemic has shaped a lot of the way we think, what we value, and how we proceed forward. Who we are and what we value is a continuing and ever-growing process, and how we choose to live our lives will play a part. 

I’m curious to hear from you, do you believe in #hustle? Are you part of the #grind culture? Or do you believe we can achieve success, greatness, and satisfaction without the hustle culture?
 

Ms. Lui is an MSc candidate at the University of Toronto, and is with the Mood Disorders Psychopharmacology Unit, Toronto Western Hospital. She has received income from Braxia Scientific. A version of this article first appeared on Medscape.com.

Thank Goodness it’s Monday? Sincerely yours, #hustle. 

The COVID-19 pandemic has given us the opportunity to reevaluate what we believe is important and valuable in our life. For some, it’s the opportunity to perform meaningful work; for others, it’s increased financial compensation; and, for the remaining, it may be autonomy (e.g., control over their time). One example of where this mindset has manifested has been in the Great Resignation. 

The Great Resignation refers to the significant increase in resignations that was recorded in April 2021. Resignation rates tend to be higher in fields with high turnover rates (e.g., health care, tech) as a result of increased demand and burnout. Although hustle culture has been an ongoing trend for the last few years, the pandemic has given somewhat of a reality check of the future. 

Hustle culture refers to the embracing of work as a lifestyle such that it takes over other important aspects of your life – in other words, when work-life balance becomes work-work (im)balance. It has also been aptly referred to as burnout culture or grind culture. It’s a bit ironic or counterintuitive to think that stopping work means increased productivity – but it’s true. 

During my undergraduate years, I was always hustling – there wasn’t a moment where I wasn’t studying, doing research, training for my sport, or thinking about how I could do better and be better. It was all about working 24/7 – an illusion to think I was being productive. Now don’t get me wrong, I think the time and effort I invested during those years paid off. However, it also resulted in a sense of dissatisfaction; that is, dissatisfaction that I didn’t explore other potential paths, that I didn’t have the courage to try new things and to be okay with making mistakes. I had extremely narrow tunnel vision because my one and only goal was to go to medical school. 

However, after entering graduate school and actually taking the time to explore other options and career pathways in health, as well as realize that nontraditional pathways are becoming more and more conventional, there is a sense of relief that “failure” is not about changing paths or making mistakes. 

The part of hustle culture that has me hung up is being able to take the time to reflect whether this is what you truly want. I still believe in the value of hard work but I also believe in the value of meaningful and efficient work while also taking the time to reflect. 

The pandemic has shaped a lot of the way we think, what we value, and how we proceed forward. Who we are and what we value is a continuing and ever-growing process, and how we choose to live our lives will play a part. 

I’m curious to hear from you, do you believe in #hustle? Are you part of the #grind culture? Or do you believe we can achieve success, greatness, and satisfaction without the hustle culture?
 

Ms. Lui is an MSc candidate at the University of Toronto, and is with the Mood Disorders Psychopharmacology Unit, Toronto Western Hospital. She has received income from Braxia Scientific. A version of this article first appeared on Medscape.com.

Thank Goodness it’s Monday? Sincerely yours, #hustle. 

The COVID-19 pandemic has given us the opportunity to reevaluate what we believe is important and valuable in our life. For some, it’s the opportunity to perform meaningful work; for others, it’s increased financial compensation; and, for the remaining, it may be autonomy (e.g., control over their time). One example of where this mindset has manifested has been in the Great Resignation. 

The Great Resignation refers to the significant increase in resignations that was recorded in April 2021. Resignation rates tend to be higher in fields with high turnover rates (e.g., health care, tech) as a result of increased demand and burnout. Although hustle culture has been an ongoing trend for the last few years, the pandemic has given somewhat of a reality check of the future. 

Hustle culture refers to the embracing of work as a lifestyle such that it takes over other important aspects of your life – in other words, when work-life balance becomes work-work (im)balance. It has also been aptly referred to as burnout culture or grind culture. It’s a bit ironic or counterintuitive to think that stopping work means increased productivity – but it’s true. 

During my undergraduate years, I was always hustling – there wasn’t a moment where I wasn’t studying, doing research, training for my sport, or thinking about how I could do better and be better. It was all about working 24/7 – an illusion to think I was being productive. Now don’t get me wrong, I think the time and effort I invested during those years paid off. However, it also resulted in a sense of dissatisfaction; that is, dissatisfaction that I didn’t explore other potential paths, that I didn’t have the courage to try new things and to be okay with making mistakes. I had extremely narrow tunnel vision because my one and only goal was to go to medical school. 

However, after entering graduate school and actually taking the time to explore other options and career pathways in health, as well as realize that nontraditional pathways are becoming more and more conventional, there is a sense of relief that “failure” is not about changing paths or making mistakes. 

The part of hustle culture that has me hung up is being able to take the time to reflect whether this is what you truly want. I still believe in the value of hard work but I also believe in the value of meaningful and efficient work while also taking the time to reflect. 

The pandemic has shaped a lot of the way we think, what we value, and how we proceed forward. Who we are and what we value is a continuing and ever-growing process, and how we choose to live our lives will play a part. 

I’m curious to hear from you, do you believe in #hustle? Are you part of the #grind culture? Or do you believe we can achieve success, greatness, and satisfaction without the hustle culture?
 

Ms. Lui is an MSc candidate at the University of Toronto, and is with the Mood Disorders Psychopharmacology Unit, Toronto Western Hospital. She has received income from Braxia Scientific. A version of this article first appeared on Medscape.com.

Breast cancer screening modality has less effect on the probability of false-positive results than screening interval, patient age, and breast density according to a new study comparing digital breast tomosynthesis (DBT) with digital mammography.

Although DBT was associated with a modest improvement in recalls for false-positive results compared with mammography, about half of women in both groups received at least one false-positive result over a 10-year period of annual screening, reported senior author Diana L. Miglioretti, PhD, from the University of California, Davis, and colleagues.

By contrast, the authors reported “substantial reductions” in false-positive recalls with biennial screening. Specifically, while annual mammography and DBT resulted in cumulative 10-year false-positive recall rates of 56.3% and 49.6% respectively, biennial rates were 38.1% and 35.7%.

The comparative effectiveness study, published in JAMA Network Open, included 903,495 women who underwent 10 years of breast cancer screening at 126 radiology facilities in the Breast Cancer Surveillance Consortium. The mean age of participants was 57.6 years, and 46% of them had dense breasts. A total of 2,969,055 screening exams were performed (15% DBT), with each woman receiving a mean of 3.3 exams over 10 years. Most participants (71.8%) had annual exams, while 16.8% had biennial, with the remainder being performed at intervals of 3 years or more.

Investigators looked at the cumulative rate of three kinds of false-positive results over 10 years: false-positive recalls for further imaging, false-positive short-interval follow-up recommendations, and false-positive biopsy recommendations. A result was considered false positive if there was no diagnosis of invasive carcinoma or ductal carcinoma in situ within 1 year of the screening examination and before the next screening examination.

Overall, across all screening intervals, and after adjusting for age and breast density, the percentage of false-positive results was slightly lower for DBT vs. mammography: 7.6% vs. 9.0%, respectively, for false-positive recalls; 1.8% vs. 2.1%, respectively, for false-positive short-interval follow-up recommendations; and 1.1% vs. 1.2% for false-positive biopsy recommendations. “We did not observe consistent clinically meaningful differences in the cumulative probabilities of false-positive short-interval follow-up or biopsy recommendation by screening modality,” they noted, adding that, although DBT provided “modest” reductions in false-positive recalls, compared with mammography (2.4% less for biennial screening and 6.7% less for annual screening), “nonetheless, this percentage equates to many thousands of individuals in absolute numbers, especially for annual screening, which is the dominant practice in the U.S.”

The authors also noted that, regardless of screening modality, all three types of false-positive results were substantially lower for biennial versus annual mammograph, and depended on age and breast density. The highest cumulative rates of false-positive results occurred in women aged 40-49 years (68.0% with annual digital mammography and 60.8% with annual DBT). Women with extremely dense breasts had the highest probability of all three types of false positive, which “may be due to the lack of interspersed fat within dense fibroglandular tissue, with the contrast between the fat and tissue being a requirement for more accurate detection of suspicious features by interpreting radiologists.”

The study findings “offer new information about the potential harms of repeated screening, which may be used to inform screening guidelines and decision-making between individuals and their physicians. However, it is important to weigh these and other potential harms with potential benefits of earlier diagnosis. … Women at high risk of an advanced cancer under biennial screening, including some women with dense breasts, may reduce their risk with annual screening,” they suggested.

Although DBT is now widely used in the United States, amid growing optimism about its superiority over digital mammography, this study reminds clinicians to counsel patients appropriately, according to Lydia E. Pace, MD, from Brigham and Women’s Hospital in Boston. “Unfortunately, the growing availability of DBT does not substantially change the likelihood that women will experience a false-positive result over years of regular mammograms,” she wrote in an invited commentary published with the study. She noted that, although many women tolerate false-positive results, “they are associated with at least transient anxiety as well as time, inconvenience, and expense. More information is needed to understand the association of DBT with overdiagnosis, which is the more clinically important harm of screening.”

The study was funded by the National Cancer Institute. Dr. Miglioretti and Dr. Pace reported no conflicts of interest. One coauthor of the study is an unpaid consultant for Grail, for the STRIVE study, and another coauthor receives personal fees from Grail for work on a data safety monitoring board. No other disclosures were reported.

Breast cancer screening modality has less effect on the probability of false-positive results than screening interval, patient age, and breast density according to a new study comparing digital breast tomosynthesis (DBT) with digital mammography.

Although DBT was associated with a modest improvement in recalls for false-positive results compared with mammography, about half of women in both groups received at least one false-positive result over a 10-year period of annual screening, reported senior author Diana L. Miglioretti, PhD, from the University of California, Davis, and colleagues.

By contrast, the authors reported “substantial reductions” in false-positive recalls with biennial screening. Specifically, while annual mammography and DBT resulted in cumulative 10-year false-positive recall rates of 56.3% and 49.6% respectively, biennial rates were 38.1% and 35.7%.

The comparative effectiveness study, published in JAMA Network Open, included 903,495 women who underwent 10 years of breast cancer screening at 126 radiology facilities in the Breast Cancer Surveillance Consortium. The mean age of participants was 57.6 years, and 46% of them had dense breasts. A total of 2,969,055 screening exams were performed (15% DBT), with each woman receiving a mean of 3.3 exams over 10 years. Most participants (71.8%) had annual exams, while 16.8% had biennial, with the remainder being performed at intervals of 3 years or more.

Investigators looked at the cumulative rate of three kinds of false-positive results over 10 years: false-positive recalls for further imaging, false-positive short-interval follow-up recommendations, and false-positive biopsy recommendations. A result was considered false positive if there was no diagnosis of invasive carcinoma or ductal carcinoma in situ within 1 year of the screening examination and before the next screening examination.

Overall, across all screening intervals, and after adjusting for age and breast density, the percentage of false-positive results was slightly lower for DBT vs. mammography: 7.6% vs. 9.0%, respectively, for false-positive recalls; 1.8% vs. 2.1%, respectively, for false-positive short-interval follow-up recommendations; and 1.1% vs. 1.2% for false-positive biopsy recommendations. “We did not observe consistent clinically meaningful differences in the cumulative probabilities of false-positive short-interval follow-up or biopsy recommendation by screening modality,” they noted, adding that, although DBT provided “modest” reductions in false-positive recalls, compared with mammography (2.4% less for biennial screening and 6.7% less for annual screening), “nonetheless, this percentage equates to many thousands of individuals in absolute numbers, especially for annual screening, which is the dominant practice in the U.S.”

The authors also noted that, regardless of screening modality, all three types of false-positive results were substantially lower for biennial versus annual mammograph, and depended on age and breast density. The highest cumulative rates of false-positive results occurred in women aged 40-49 years (68.0% with annual digital mammography and 60.8% with annual DBT). Women with extremely dense breasts had the highest probability of all three types of false positive, which “may be due to the lack of interspersed fat within dense fibroglandular tissue, with the contrast between the fat and tissue being a requirement for more accurate detection of suspicious features by interpreting radiologists.”

The study findings “offer new information about the potential harms of repeated screening, which may be used to inform screening guidelines and decision-making between individuals and their physicians. However, it is important to weigh these and other potential harms with potential benefits of earlier diagnosis. … Women at high risk of an advanced cancer under biennial screening, including some women with dense breasts, may reduce their risk with annual screening,” they suggested.

Although DBT is now widely used in the United States, amid growing optimism about its superiority over digital mammography, this study reminds clinicians to counsel patients appropriately, according to Lydia E. Pace, MD, from Brigham and Women’s Hospital in Boston. “Unfortunately, the growing availability of DBT does not substantially change the likelihood that women will experience a false-positive result over years of regular mammograms,” she wrote in an invited commentary published with the study. She noted that, although many women tolerate false-positive results, “they are associated with at least transient anxiety as well as time, inconvenience, and expense. More information is needed to understand the association of DBT with overdiagnosis, which is the more clinically important harm of screening.”

The study was funded by the National Cancer Institute. Dr. Miglioretti and Dr. Pace reported no conflicts of interest. One coauthor of the study is an unpaid consultant for Grail, for the STRIVE study, and another coauthor receives personal fees from Grail for work on a data safety monitoring board. No other disclosures were reported.

Breast cancer screening modality has less effect on the probability of false-positive results than screening interval, patient age, and breast density according to a new study comparing digital breast tomosynthesis (DBT) with digital mammography.

Although DBT was associated with a modest improvement in recalls for false-positive results compared with mammography, about half of women in both groups received at least one false-positive result over a 10-year period of annual screening, reported senior author Diana L. Miglioretti, PhD, from the University of California, Davis, and colleagues.

By contrast, the authors reported “substantial reductions” in false-positive recalls with biennial screening. Specifically, while annual mammography and DBT resulted in cumulative 10-year false-positive recall rates of 56.3% and 49.6% respectively, biennial rates were 38.1% and 35.7%.

The comparative effectiveness study, published in JAMA Network Open, included 903,495 women who underwent 10 years of breast cancer screening at 126 radiology facilities in the Breast Cancer Surveillance Consortium. The mean age of participants was 57.6 years, and 46% of them had dense breasts. A total of 2,969,055 screening exams were performed (15% DBT), with each woman receiving a mean of 3.3 exams over 10 years. Most participants (71.8%) had annual exams, while 16.8% had biennial, with the remainder being performed at intervals of 3 years or more.

Investigators looked at the cumulative rate of three kinds of false-positive results over 10 years: false-positive recalls for further imaging, false-positive short-interval follow-up recommendations, and false-positive biopsy recommendations. A result was considered false positive if there was no diagnosis of invasive carcinoma or ductal carcinoma in situ within 1 year of the screening examination and before the next screening examination.

Overall, across all screening intervals, and after adjusting for age and breast density, the percentage of false-positive results was slightly lower for DBT vs. mammography: 7.6% vs. 9.0%, respectively, for false-positive recalls; 1.8% vs. 2.1%, respectively, for false-positive short-interval follow-up recommendations; and 1.1% vs. 1.2% for false-positive biopsy recommendations. “We did not observe consistent clinically meaningful differences in the cumulative probabilities of false-positive short-interval follow-up or biopsy recommendation by screening modality,” they noted, adding that, although DBT provided “modest” reductions in false-positive recalls, compared with mammography (2.4% less for biennial screening and 6.7% less for annual screening), “nonetheless, this percentage equates to many thousands of individuals in absolute numbers, especially for annual screening, which is the dominant practice in the U.S.”

The authors also noted that, regardless of screening modality, all three types of false-positive results were substantially lower for biennial versus annual mammograph, and depended on age and breast density. The highest cumulative rates of false-positive results occurred in women aged 40-49 years (68.0% with annual digital mammography and 60.8% with annual DBT). Women with extremely dense breasts had the highest probability of all three types of false positive, which “may be due to the lack of interspersed fat within dense fibroglandular tissue, with the contrast between the fat and tissue being a requirement for more accurate detection of suspicious features by interpreting radiologists.”

The study findings “offer new information about the potential harms of repeated screening, which may be used to inform screening guidelines and decision-making between individuals and their physicians. However, it is important to weigh these and other potential harms with potential benefits of earlier diagnosis. … Women at high risk of an advanced cancer under biennial screening, including some women with dense breasts, may reduce their risk with annual screening,” they suggested.

Although DBT is now widely used in the United States, amid growing optimism about its superiority over digital mammography, this study reminds clinicians to counsel patients appropriately, according to Lydia E. Pace, MD, from Brigham and Women’s Hospital in Boston. “Unfortunately, the growing availability of DBT does not substantially change the likelihood that women will experience a false-positive result over years of regular mammograms,” she wrote in an invited commentary published with the study. She noted that, although many women tolerate false-positive results, “they are associated with at least transient anxiety as well as time, inconvenience, and expense. More information is needed to understand the association of DBT with overdiagnosis, which is the more clinically important harm of screening.”

The study was funded by the National Cancer Institute. Dr. Miglioretti and Dr. Pace reported no conflicts of interest. One coauthor of the study is an unpaid consultant for Grail, for the STRIVE study, and another coauthor receives personal fees from Grail for work on a data safety monitoring board. No other disclosures were reported.

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

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

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

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

During a recent virtual medical malpractice trial, the judge called a break, and the participants left their screens. When the trial resumed a short time later, one juror was missing. The court called his phone, but there was no answer.

“Everyone had to keep waiting and waiting while the bailiff kept trying to call,” recalled Elizabeth Leedom, a medical malpractice defense attorney based in Seattle. “The juror fell asleep.”

The sleeping juror caused a significant delay in the trial, Ms. Leedom said. Finally, he woke up, and the trial was able to continue.

In another instance, a potential juror showed up drunk to a virtual jury selection. The man was slurring his words as he answered questions, Ms. Leedom said, and when asked if he was okay, he admitted that he had a drinking problem. The judge asked whether he had consumed alcohol, and the man admitted that he’d been drinking that day. He was excused from jury selection.

These alarming incidents are among the mishaps that happen during virtual medical malpractice trials. Since the pandemic started, many courts have moved to virtual settings to slow the spread of COVID-19. Although some courts have now shifted back to in-person trials, some areas continue to mandate virtual malpractice trials, hearings, and depositions.

Such trials can save money and are convenient, but legal experts say virtual trials present serious challenges for physicians and raise concerns about fairness. Some jurors are not taking virtual cases seriously or do not stay focused on the subject matter, according to attorneys.

“Virtual trials are not as fair to physicians as in-person trials,” said Andrew DeSimone, a medical malpractice defense attorney based in Lexington, Ky. “It’s too easy not to pay attention in a virtual setting. And when you are dealing with complex medical topics, juror attention is a paramount issue.”
 

Casual settings, constant interruptions during jury selections

Understanding and reaching the jury have been the greatest challenges with virtual and hybrid trials, said Laura Eschleman, a medical liability defense attorney based in Atlanta. Hybrid trials are part virtual and part in person.

Ms. Eschleman has participated in jury selections via Zoom in which jurors lounge in bed during the process and spouses and children waltz into the room as they please, she said.

“With over 36 Zoom boxes of potential jurors, assessing each potential juror was difficult to say the least,” she said. “[Jury selection] has always been an opportunity to introduce the defendant physicians to the jurors as humans; doing it virtually took that away. It is difficult to humanize a box on a screen.”

Regarding one virtual jury selection, Ms. Eschleman said the court had narrowed the pool to a final 12 jurors when one juror’s wife burst into his room and started yelling in front of his computer.

The judge allowed her to speak, and the crying woman begged the judge not to select her husband for the trial because it would disrupt the couple’s child care. After a lengthy exchange, they learned that the child was 16 years old and had his own car. The husband disagreed with his wife and wanted to remain a juror.

“This would have never happened had the twelfth juror been called to an in-person jury selection,” Ms. Eschleman said.

Keeping juries focused while the trial is underway can also be a problem, DeSimone said. He describes the courtroom during malpractice trials as a theater of sorts. Jurors watch intently as witnesses testify, evidence is presented, and the judge gives instructions. During virtual trials, however, watching through a screen doesn’t always yield the same captive audiences, he said.

“During Zoom, it’s much harder to connect with the jury because they won’t be as tuned into it,” he said. “If the jury believes the physician is empathetic, conscientious, caring, and compassionate, they will give the physician the benefit of the doubt, even if something went wrong or a bad outcome occurred. Developing that connection through good eye contact, being a teacher, and showing compassion is the most important thing a physician can do when testifying.”

A related challenge is that medical experts can’t connect as well with jurors, and some may have trouble conveying their message from a screen, said Evan Lyman, a medical malpractice defense attorney based in White Plains, N.Y.

“Some experts like to get out of the witness box and kind of take over the courtroom with a laser pointer or a white board,” he said. “For some, that’s what makes them effective experts. Some experts lose their touch when they can’t do that.”

Technical difficulties during virtual trials can cause further woes, said Kari Adams, vice president of claims for Physicians Insurance – A Mutual Company. She recalled a recent case in which technical problems arose during the defense attorney’s closing arguments.

“It’s hard to see our defense attorneys who are used to using all of their advocacy skills, all of their charisma trying to convey it in a virtual format,” she said. “When it’s disrupted, it can really throw things. A lot of their advocacy and personality can play through, but it’s just a little less in that forum.”
 

Doc fights against virtual trial

When Texas cardiologist Amin Al-Ahmad’s malpractice trial was changed to a virtual format because of COVID-19 concerns, Dr. Al-Ahmad and his attorneys fought the move.

They argued that the malpractice case was too complex for a virtual format and that a video trial would deprive Dr. Al-Ahmad of his rights to due process, including the right to trial by jury.

Dr. Al-Ahmad’s case involved allegations that he had failed to promptly diagnose and treat an atrial esophageal fistula, resulting in a patient’s stroke and ongoing neurologic problems. The trial was expected to last up to 10 days. Nine witnesses were expected to testify, and $1 million in damages were at stake, according to court documents.

“The length of trial anticipated, complexity of the medical issues, the confidential medical information at issue, and the number of anticipated medical records exhibits lead to a real risk of juror ‘Zoom fatigue,’ even if the trial is not interrupted with technology glitches, such as jurors dropping off the link or sound loss,” Dr. Al-Ahmad’s attorneys wrote in a petition to the Texas Supreme Court. “The risks of forcing [the defendants] to trial through the procedure of a remote or virtual jury trial are numerous. Not least of these is the risk that [defendants’] relators will be prevented from presenting an adequate defense or being able to fully preserve error during a virtual trial.”

Another concern regards the lack of uniformity from county to county in conducting a virtual trial, said David A. Wright, an attorney for Dr. Al-Ahmad. Some counties don’t permit them, while others permit parties to opt out of virtual trials, he noted.

“Even those that hold virtual trials seem to have different procedures and rules,” he said. “Travis County, where I have tried my virtual cases, has iPads that they provide to each juror so that they are limited to using just the county iPad for the trial. Others, I have heard, permit jurors to use their own devices. There are simply no uniform rules.”

Despite requests to the trial court and petitions to the appellate and Texas Supreme Court, Dr. Al-Ahmad lost his bid to have his trial delayed until in-person trials resumed. The Texas Supreme Court in late 2021 refused to halt the virtual trial.

Dr. Al-Ahmad, based in Austin, declined to comment through his attorney. Mr. Wright said the court’s denial “was not unexpected.”

Dr. Al-Ahmad’s virtual trial went forward in October 2021, and the jury ruled in his favor.

“We were very pleased with the jury’s verdict,” Mr. Wright said.
 

Are virtual trials ending in higher awards?

In addition to jurors’ not taking their roles as seriously, the casual vibe of virtual trials may also be diminishing how jurors view the verdict’s magnitude.

“Virtual trials don’t have the gravity or the seriousness of a real trial,” Ms. Leedom said. “I don’t think the importance of the jury’s decision weighs on them as much during a Zoom trial as it does an in-person trial.”

Alarmingly, Ms. Leedom said that, in her experience, damages in virtual trials have been higher in comparison with damages awarded during in-person trials.

Ms. Adams agreed with this observation.

“We’ll still win cases, but we’re concerned that, in the cases we lose, the damages can be slightly higher because there hasn’t been that interpersonal connection with the defendant,” she said. “It almost becomes like monopoly money to jurors.”
 

Remember these tips during virtual trials

Physicians undergoing virtual trials may have better experiences if they keep a few tips in mind.

Mr. DeSimone emphasized the importance of eye contact with jurors, which can be tricky during virtual settings. It helps if physicians look at the camera, rather than the screen, while talking.

Physicians should be cognizant of their facial expressions as they watch others speak.

“Don’t roll your eyes like: ‘Oh my gosh, he’s an idiot,’ ” Mr. DeSimone said. “Keep a poker face. Be respectful of what’s going on. Don’t be lulled into letting your guard down.”

Before the virtual trial, practice the cross examination and direct examination with your attorney and record it, Ms. Leedom said. That way, doctors can watch how they present on video and make necessary changes before the real trial. Lighting is also important, she noted. Her firm provides special lamps to clients and witnesses for virtual trials and proceedings.

“The lighting makes a huge difference,” she said.

Its also a good idea for physicians to have a paper copy of the records or exhibits that are going to be used so it’s easy for them to flip through them while on the screen. Physicians should also be mindful of how they come across during video depositions, which are sometimes played during virtual trials, Ms. Adams said.

“If you’re not looking professional during the video deposition – you’re eating, you’re not dressed well – the plaintiff’s attorney will take the most inopportune segment of the deposition and portray the physician as: ‘Look, here’s someone who was careless in the medical care, and look, they don’t even look professional when they’re testifying about this horrifying experience,’ ” she said. “They’ll use the clips to make a very careful provider appear distracted.”
 

Are virtual trials and hearings here to stay?

Whether virtual malpractice trials continue will largely depend on the location in which physicians practice. Some insurance carriers are opting to continue virtual trials, but in some areas, trials are being delayed until in-person proceedings can resume, Ms. Adams said. Some areas never adopted video trials and never ceased in-person trials.

“I think it’s going to be very regionally based,” she said. “Some of the smaller, rural counties just don’t have the capacity or the resources to continue, so they’ll probably just go back to in person.”

Not all virtual proceedings are problematic for physicians, say legal experts. Virtual depositions can be beneficial for doctors because they are less intimidating and confrontational than in-person depositions, Mr. Lyman said.

Additionally, virtual mediations can take much less time than in-person mediations, Ms. Adams said. Video depositions and mediations also save travel costs and reduce time missed from work for physicians.

“But I hope we all go back to in-person trials,” Ms. Leedom said. “Even here in King County, [Washington,] where we’ve done federal and state court trials by Zoom, I’m hopeful that it will go back to in-person trials.”

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