Ob.Gyn. News

Takeaway

• Early or delayed menopause and a history of irregular menstrual cycles were significantly associated with a greater risk of new-onset atrial fibrillation (AF) in women.
• Women with nulliparity and multiparity had a greater risk of new-onset AF compared with those with one to two live births.

Why this matters

• Findings highlight the significance of considering the reproductive history of women while developing tailored screening and prevention strategies for AF.

Study design

• A population-based cohort study of 235,191 women (age, 40-69 years) without AF and a history of hysterectomy and/or bilateral oophorectomy, identified from the UK Biobank (2006-2010).
• Funding: Gender and Prevention Grant from ZonMw and other.

Key results

• During a median follow-up of 11.6 years, 4,629 (2.0%) women were diagnosed with new-onset AF.
• A history of irregular menstrual cycle was associated with higher risk of new-onset AF (adjusted HR, 1.34; 95% confidence interval, 1.01-1.79; P = .04).
• Compared with women who experienced menarche at the age of 12 years, the risk of new-onset AF was significantly higher in those who experienced menarche:
• –Earlier between the ages of 7 and 11 years (aHR, 1.10; 95% CI, 1.00-1.21; P = .04) and
• –Later between the ages of 13 and 18 years (aHR, 1.08; 95% CI, 1.00-1.17; P = .05).

• The risk of new-onset AF was significantly higher in women who experienced menopause:
• –At the age of < 35 years (aHR, 2.25; 95% CI, 1.48-3.43; P < .001);
• –Between the ages of 35 and 44 years (aHR, 1.24; 95% CI, 1.10-1.39; P < .001); and
• –At the age of ≥ 60 years (aHR, 1.34; 95% CI, 1.10-1.78; P = .04).
• Women with no live births (aHR, 1.13; 95% CI, 1.04-1.24; P < .01), four to six live births (aHR, 1.12; 95% CI, 1.01-1.24; P = .04), and ≥ seven live births (aHR, 1.67; 95% CI, 1.03-2.70; P = .03) vs. those with one to two live births had a significantly higher risk of new-onset AF.

Limitations

• Observational design.

A version of this article first appeared on Medscape UK.

Reference

Lu Z, Aribas E, Geurts S, Roeters van Lennep JE, Ikram MA, Bos MM, de Groot NMS, Kavousi M. Association Between Sex-Specific Risk Factors and Risk of New-Onset Atrial Fibrillation Among Women. JAMA Netw Open. 2022;5(9):e2229716. doi: 10.1001/jamanetworkopen.2022.29716. PMID: 36048441.

Takeaway

• Early or delayed menopause and a history of irregular menstrual cycles were significantly associated with a greater risk of new-onset atrial fibrillation (AF) in women.
• Women with nulliparity and multiparity had a greater risk of new-onset AF compared with those with one to two live births.

Why this matters

• Findings highlight the significance of considering the reproductive history of women while developing tailored screening and prevention strategies for AF.

Study design

• A population-based cohort study of 235,191 women (age, 40-69 years) without AF and a history of hysterectomy and/or bilateral oophorectomy, identified from the UK Biobank (2006-2010).
• Funding: Gender and Prevention Grant from ZonMw and other.

Key results

• During a median follow-up of 11.6 years, 4,629 (2.0%) women were diagnosed with new-onset AF.
• A history of irregular menstrual cycle was associated with higher risk of new-onset AF (adjusted HR, 1.34; 95% confidence interval, 1.01-1.79; P = .04).
• Compared with women who experienced menarche at the age of 12 years, the risk of new-onset AF was significantly higher in those who experienced menarche:
• –Earlier between the ages of 7 and 11 years (aHR, 1.10; 95% CI, 1.00-1.21; P = .04) and
• –Later between the ages of 13 and 18 years (aHR, 1.08; 95% CI, 1.00-1.17; P = .05).

• The risk of new-onset AF was significantly higher in women who experienced menopause:
• –At the age of < 35 years (aHR, 2.25; 95% CI, 1.48-3.43; P < .001);
• –Between the ages of 35 and 44 years (aHR, 1.24; 95% CI, 1.10-1.39; P < .001); and
• –At the age of ≥ 60 years (aHR, 1.34; 95% CI, 1.10-1.78; P = .04).
• Women with no live births (aHR, 1.13; 95% CI, 1.04-1.24; P < .01), four to six live births (aHR, 1.12; 95% CI, 1.01-1.24; P = .04), and ≥ seven live births (aHR, 1.67; 95% CI, 1.03-2.70; P = .03) vs. those with one to two live births had a significantly higher risk of new-onset AF.

Limitations

• Observational design.

A version of this article first appeared on Medscape UK.

Reference

Lu Z, Aribas E, Geurts S, Roeters van Lennep JE, Ikram MA, Bos MM, de Groot NMS, Kavousi M. Association Between Sex-Specific Risk Factors and Risk of New-Onset Atrial Fibrillation Among Women. JAMA Netw Open. 2022;5(9):e2229716. doi: 10.1001/jamanetworkopen.2022.29716. PMID: 36048441.

Takeaway

• Early or delayed menopause and a history of irregular menstrual cycles were significantly associated with a greater risk of new-onset atrial fibrillation (AF) in women.
• Women with nulliparity and multiparity had a greater risk of new-onset AF compared with those with one to two live births.

Why this matters

• Findings highlight the significance of considering the reproductive history of women while developing tailored screening and prevention strategies for AF.

Study design

• A population-based cohort study of 235,191 women (age, 40-69 years) without AF and a history of hysterectomy and/or bilateral oophorectomy, identified from the UK Biobank (2006-2010).
• Funding: Gender and Prevention Grant from ZonMw and other.

Key results

• During a median follow-up of 11.6 years, 4,629 (2.0%) women were diagnosed with new-onset AF.
• A history of irregular menstrual cycle was associated with higher risk of new-onset AF (adjusted HR, 1.34; 95% confidence interval, 1.01-1.79; P = .04).
• Compared with women who experienced menarche at the age of 12 years, the risk of new-onset AF was significantly higher in those who experienced menarche:
• –Earlier between the ages of 7 and 11 years (aHR, 1.10; 95% CI, 1.00-1.21; P = .04) and
• –Later between the ages of 13 and 18 years (aHR, 1.08; 95% CI, 1.00-1.17; P = .05).

• The risk of new-onset AF was significantly higher in women who experienced menopause:
• –At the age of < 35 years (aHR, 2.25; 95% CI, 1.48-3.43; P < .001);
• –Between the ages of 35 and 44 years (aHR, 1.24; 95% CI, 1.10-1.39; P < .001); and
• –At the age of ≥ 60 years (aHR, 1.34; 95% CI, 1.10-1.78; P = .04).
• Women with no live births (aHR, 1.13; 95% CI, 1.04-1.24; P < .01), four to six live births (aHR, 1.12; 95% CI, 1.01-1.24; P = .04), and ≥ seven live births (aHR, 1.67; 95% CI, 1.03-2.70; P = .03) vs. those with one to two live births had a significantly higher risk of new-onset AF.

Limitations

• Observational design.

A version of this article first appeared on Medscape UK.

Reference

Lu Z, Aribas E, Geurts S, Roeters van Lennep JE, Ikram MA, Bos MM, de Groot NMS, Kavousi M. Association Between Sex-Specific Risk Factors and Risk of New-Onset Atrial Fibrillation Among Women. JAMA Netw Open. 2022;5(9):e2229716. doi: 10.1001/jamanetworkopen.2022.29716. PMID: 36048441.

More than 80% of U.S. maternal deaths across a 2-year period were due to preventable causes, according to a new CDC report.

Black mothers made up about a third of deaths, and more than 90% of deaths among Indigenous mothers were preventable.

“It’s significant. It’s staggering. It’s heartbreaking,” Allison Bryant, MD, a high-risk pregnancy specialist and senior medical director for health equity at Massachusetts General Hospital, told USA Today.

“It just means that we have so much work to do,” she said.

In the report, CDC researchers looked at pregnancy-related deaths between 2017 to 2019 based on numbers from maternal mortality review committees, which are multidisciplinary groups in 36 states that investigate the circumstances around maternal deaths.

Of the 1,018 deaths during the 2-year period, 839 occurred up to a year after delivery. About 22% of deaths happened during pregnancy, and 25% happened on the day of delivery or within a week after delivery. But 53% occurred more than 7 days after delivery.

Mental health conditions, such as overdoses and deaths by suicide, were the top underlying cause, followed by hemorrhage, or extreme bleeding. About a quarter of deaths were due to mental health conditions, followed by 14% due to hemorrhage and 13% due to heart problems. The rest were related to infection, embolism, cardiomyopathy, and high blood pressure-related disorders.

The analysis included a section on maternal deaths for American Indian and Alaska Native mothers, who are more than twice as likely as White mothers to die but are often undercounted in health data due to misclassification. More than 90% of their deaths were preventable between 2017 to 2019, with most due to mental health conditions and hemorrhage.

“It’s incredibly distressful,” Brian Thompson, MD, of the Oneida Nation and assistant professor of obstetrics and gynecology at Upstate Medical University, New York, told USA Today.

Dr. Thompson is working with the National Indian Health Board to create the first national tribal review committee for maternal deaths.

“It really needs to be looked at and examined why that is the case if essentially all of them are preventable,” he said.

Black mothers were also three times as likely as White mothers to die and more likely to die from heart problems. Hispanic mothers, who made up 14% of deaths, were more likely to die from mental health conditions.

Some of the deaths, such as hemorrhage, should be highly preventable. Existing toolkits for clinicians provide evidence-based guidelines to prevent and treat excessive bleeding.

“No pregnant person should be passing away from a hemorrhage,” Andrea Jackson, MD, division chief of obstetrics and gynecology at the University of California, San Francisco, told USA Today.

“We have the tools in the United States, and we know how to deal with it,” she said. “That was really disheartening to see.”

What’s more, the new CDC report highlights the need for more mental health resources during pregnancy and the postpartum period – up to a year or more after delivery – including improvements in access to care, diagnosis, and treatment.

“These are things that need to happen systemically,” LeThenia Baker, MD, an obstetrician and gynecologist at Wellstar Health, Georgia, told USA Today.

“It can’t just be a few practices here or there who are adopting best practices,” she said. “It has to be a systemic change.”

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

More than 80% of U.S. maternal deaths across a 2-year period were due to preventable causes, according to a new CDC report.

Black mothers made up about a third of deaths, and more than 90% of deaths among Indigenous mothers were preventable.

“It’s significant. It’s staggering. It’s heartbreaking,” Allison Bryant, MD, a high-risk pregnancy specialist and senior medical director for health equity at Massachusetts General Hospital, told USA Today.

“It just means that we have so much work to do,” she said.

In the report, CDC researchers looked at pregnancy-related deaths between 2017 to 2019 based on numbers from maternal mortality review committees, which are multidisciplinary groups in 36 states that investigate the circumstances around maternal deaths.

Of the 1,018 deaths during the 2-year period, 839 occurred up to a year after delivery. About 22% of deaths happened during pregnancy, and 25% happened on the day of delivery or within a week after delivery. But 53% occurred more than 7 days after delivery.

Mental health conditions, such as overdoses and deaths by suicide, were the top underlying cause, followed by hemorrhage, or extreme bleeding. About a quarter of deaths were due to mental health conditions, followed by 14% due to hemorrhage and 13% due to heart problems. The rest were related to infection, embolism, cardiomyopathy, and high blood pressure-related disorders.

The analysis included a section on maternal deaths for American Indian and Alaska Native mothers, who are more than twice as likely as White mothers to die but are often undercounted in health data due to misclassification. More than 90% of their deaths were preventable between 2017 to 2019, with most due to mental health conditions and hemorrhage.

“It’s incredibly distressful,” Brian Thompson, MD, of the Oneida Nation and assistant professor of obstetrics and gynecology at Upstate Medical University, New York, told USA Today.

Dr. Thompson is working with the National Indian Health Board to create the first national tribal review committee for maternal deaths.

“It really needs to be looked at and examined why that is the case if essentially all of them are preventable,” he said.

Black mothers were also three times as likely as White mothers to die and more likely to die from heart problems. Hispanic mothers, who made up 14% of deaths, were more likely to die from mental health conditions.

Some of the deaths, such as hemorrhage, should be highly preventable. Existing toolkits for clinicians provide evidence-based guidelines to prevent and treat excessive bleeding.

“No pregnant person should be passing away from a hemorrhage,” Andrea Jackson, MD, division chief of obstetrics and gynecology at the University of California, San Francisco, told USA Today.

“We have the tools in the United States, and we know how to deal with it,” she said. “That was really disheartening to see.”

What’s more, the new CDC report highlights the need for more mental health resources during pregnancy and the postpartum period – up to a year or more after delivery – including improvements in access to care, diagnosis, and treatment.

“These are things that need to happen systemically,” LeThenia Baker, MD, an obstetrician and gynecologist at Wellstar Health, Georgia, told USA Today.

“It can’t just be a few practices here or there who are adopting best practices,” she said. “It has to be a systemic change.”

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

More than 80% of U.S. maternal deaths across a 2-year period were due to preventable causes, according to a new CDC report.

Black mothers made up about a third of deaths, and more than 90% of deaths among Indigenous mothers were preventable.

“It’s significant. It’s staggering. It’s heartbreaking,” Allison Bryant, MD, a high-risk pregnancy specialist and senior medical director for health equity at Massachusetts General Hospital, told USA Today.

“It just means that we have so much work to do,” she said.

In the report, CDC researchers looked at pregnancy-related deaths between 2017 to 2019 based on numbers from maternal mortality review committees, which are multidisciplinary groups in 36 states that investigate the circumstances around maternal deaths.

Of the 1,018 deaths during the 2-year period, 839 occurred up to a year after delivery. About 22% of deaths happened during pregnancy, and 25% happened on the day of delivery or within a week after delivery. But 53% occurred more than 7 days after delivery.

Mental health conditions, such as overdoses and deaths by suicide, were the top underlying cause, followed by hemorrhage, or extreme bleeding. About a quarter of deaths were due to mental health conditions, followed by 14% due to hemorrhage and 13% due to heart problems. The rest were related to infection, embolism, cardiomyopathy, and high blood pressure-related disorders.

The analysis included a section on maternal deaths for American Indian and Alaska Native mothers, who are more than twice as likely as White mothers to die but are often undercounted in health data due to misclassification. More than 90% of their deaths were preventable between 2017 to 2019, with most due to mental health conditions and hemorrhage.

“It’s incredibly distressful,” Brian Thompson, MD, of the Oneida Nation and assistant professor of obstetrics and gynecology at Upstate Medical University, New York, told USA Today.

Dr. Thompson is working with the National Indian Health Board to create the first national tribal review committee for maternal deaths.

“It really needs to be looked at and examined why that is the case if essentially all of them are preventable,” he said.

Black mothers were also three times as likely as White mothers to die and more likely to die from heart problems. Hispanic mothers, who made up 14% of deaths, were more likely to die from mental health conditions.

Some of the deaths, such as hemorrhage, should be highly preventable. Existing toolkits for clinicians provide evidence-based guidelines to prevent and treat excessive bleeding.

“No pregnant person should be passing away from a hemorrhage,” Andrea Jackson, MD, division chief of obstetrics and gynecology at the University of California, San Francisco, told USA Today.

“We have the tools in the United States, and we know how to deal with it,” she said. “That was really disheartening to see.”

What’s more, the new CDC report highlights the need for more mental health resources during pregnancy and the postpartum period – up to a year or more after delivery – including improvements in access to care, diagnosis, and treatment.

“These are things that need to happen systemically,” LeThenia Baker, MD, an obstetrician and gynecologist at Wellstar Health, Georgia, told USA Today.

“It can’t just be a few practices here or there who are adopting best practices,” she said. “It has to be a systemic change.”

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

Queen Elizabeth is everywhere. She was even on the last slide of a presentation on COVID, monkeypox, and influenza vaccines given by our physician in charge of quality. This was odd. The presenter wasn’t English. The Queen had nothing to do with vaccines. Nor apparently would she have said even if she did have an opinion about them. But there we were, an audience of physicians and staff pausing for a moment of remembrance of her.

I’m not a Monarchist – except perhaps for the Kennedys. I grew up in New England. I don’t have an opinion on whether or not the British Crown should endure. But I do marvel at the astounding effect Queen Elizabeth’s passing had on so many around the world. Her personal qualities, particularly her steadiness and humane sympathy, might explain why so many are sad hearing the news. But also I think there was something in her role that we all wished for: Not the owning of palaces and sceptres, but rather, the respect that was given to her.

She was a stateswoman of “unmatched dignity,” the White House wrote. That was true, but it seems being the Queen might have been the last job on earth where such dignity is still possible. Certainly in politics, education, and even health care, there doesn’t seem to be much left lately.

The same day of that presentation I walked into the room of a patient 22 minutes late, she held her arm forth tapping her watch to indicate the time and my tardiness. Unnecessary, if not impertinent. Covering for one of my female physician colleagues, I read an email from a patient which began, “Dear Julie, With all due respect …” Another patient submitted a photo for us to review that was clearly taken from her car while waiting at a stop light. Hardly the consideration a clinical encounter should be given.

Much has been lost for patients. too. There are patients trying to make appointments lately who are told: “There are none. Call back later.” Gone it seems are the days of a two-part office visit, the first part fully clothed in the physician’s office, then the exam. There is no dignified way to remove exam paper stuck to your backside before introducing yourself to the doctor. Maybe that last slide of Her Majesty was in fact for us to have a moment of silence for what we’ve all lost.

Walter Bagehot (pronounce it “Baj-et” if you tell this story to your Harlan wine friends) was a political writer and editor of The Economist in the 1860s. He famously said that the secret to the English government was having two kinds of institutions, the dignified and the efficient. The efficient, Parliament, was responsible for all the work. The dignified, the Crown, gives significance and holds everyone’s respect. If medicine ever once was both dignified and efficient, we aren’t lately. We push to reduce backlogs, offer same-time virtual care, work to reduce costs. We’ve driven medicine to the efficient and left little of the dignity it seems.

The Queen will be remembered for her lifelong dedication to the laborious service of others. Even though each of us in medicine pledges the same, we also mourn this week the loss of dignity that once came with it.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Queen Elizabeth is everywhere. She was even on the last slide of a presentation on COVID, monkeypox, and influenza vaccines given by our physician in charge of quality. This was odd. The presenter wasn’t English. The Queen had nothing to do with vaccines. Nor apparently would she have said even if she did have an opinion about them. But there we were, an audience of physicians and staff pausing for a moment of remembrance of her.

I’m not a Monarchist – except perhaps for the Kennedys. I grew up in New England. I don’t have an opinion on whether or not the British Crown should endure. But I do marvel at the astounding effect Queen Elizabeth’s passing had on so many around the world. Her personal qualities, particularly her steadiness and humane sympathy, might explain why so many are sad hearing the news. But also I think there was something in her role that we all wished for: Not the owning of palaces and sceptres, but rather, the respect that was given to her.

She was a stateswoman of “unmatched dignity,” the White House wrote. That was true, but it seems being the Queen might have been the last job on earth where such dignity is still possible. Certainly in politics, education, and even health care, there doesn’t seem to be much left lately.

The same day of that presentation I walked into the room of a patient 22 minutes late, she held her arm forth tapping her watch to indicate the time and my tardiness. Unnecessary, if not impertinent. Covering for one of my female physician colleagues, I read an email from a patient which began, “Dear Julie, With all due respect …” Another patient submitted a photo for us to review that was clearly taken from her car while waiting at a stop light. Hardly the consideration a clinical encounter should be given.

Much has been lost for patients. too. There are patients trying to make appointments lately who are told: “There are none. Call back later.” Gone it seems are the days of a two-part office visit, the first part fully clothed in the physician’s office, then the exam. There is no dignified way to remove exam paper stuck to your backside before introducing yourself to the doctor. Maybe that last slide of Her Majesty was in fact for us to have a moment of silence for what we’ve all lost.

Walter Bagehot (pronounce it “Baj-et” if you tell this story to your Harlan wine friends) was a political writer and editor of The Economist in the 1860s. He famously said that the secret to the English government was having two kinds of institutions, the dignified and the efficient. The efficient, Parliament, was responsible for all the work. The dignified, the Crown, gives significance and holds everyone’s respect. If medicine ever once was both dignified and efficient, we aren’t lately. We push to reduce backlogs, offer same-time virtual care, work to reduce costs. We’ve driven medicine to the efficient and left little of the dignity it seems.

The Queen will be remembered for her lifelong dedication to the laborious service of others. Even though each of us in medicine pledges the same, we also mourn this week the loss of dignity that once came with it.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Queen Elizabeth is everywhere. She was even on the last slide of a presentation on COVID, monkeypox, and influenza vaccines given by our physician in charge of quality. This was odd. The presenter wasn’t English. The Queen had nothing to do with vaccines. Nor apparently would she have said even if she did have an opinion about them. But there we were, an audience of physicians and staff pausing for a moment of remembrance of her.

I’m not a Monarchist – except perhaps for the Kennedys. I grew up in New England. I don’t have an opinion on whether or not the British Crown should endure. But I do marvel at the astounding effect Queen Elizabeth’s passing had on so many around the world. Her personal qualities, particularly her steadiness and humane sympathy, might explain why so many are sad hearing the news. But also I think there was something in her role that we all wished for: Not the owning of palaces and sceptres, but rather, the respect that was given to her.

She was a stateswoman of “unmatched dignity,” the White House wrote. That was true, but it seems being the Queen might have been the last job on earth where such dignity is still possible. Certainly in politics, education, and even health care, there doesn’t seem to be much left lately.

The same day of that presentation I walked into the room of a patient 22 minutes late, she held her arm forth tapping her watch to indicate the time and my tardiness. Unnecessary, if not impertinent. Covering for one of my female physician colleagues, I read an email from a patient which began, “Dear Julie, With all due respect …” Another patient submitted a photo for us to review that was clearly taken from her car while waiting at a stop light. Hardly the consideration a clinical encounter should be given.

Much has been lost for patients. too. There are patients trying to make appointments lately who are told: “There are none. Call back later.” Gone it seems are the days of a two-part office visit, the first part fully clothed in the physician’s office, then the exam. There is no dignified way to remove exam paper stuck to your backside before introducing yourself to the doctor. Maybe that last slide of Her Majesty was in fact for us to have a moment of silence for what we’ve all lost.

Walter Bagehot (pronounce it “Baj-et” if you tell this story to your Harlan wine friends) was a political writer and editor of The Economist in the 1860s. He famously said that the secret to the English government was having two kinds of institutions, the dignified and the efficient. The efficient, Parliament, was responsible for all the work. The dignified, the Crown, gives significance and holds everyone’s respect. If medicine ever once was both dignified and efficient, we aren’t lately. We push to reduce backlogs, offer same-time virtual care, work to reduce costs. We’ve driven medicine to the efficient and left little of the dignity it seems.

The Queen will be remembered for her lifelong dedication to the laborious service of others. Even though each of us in medicine pledges the same, we also mourn this week the loss of dignity that once came with it.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

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

More than two dozen patient advocacy organizations have raised alarms about a recent court ruling that could threaten patient access to no-cost preventive screenings, including cancer screenings.

In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”

The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).

Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.

The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.

But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.

After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.

In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.

Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”

In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.

“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.

For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.

“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”

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

More than two dozen patient advocacy organizations have raised alarms about a recent court ruling that could threaten patient access to no-cost preventive screenings, including cancer screenings.

In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”

The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).

Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.

The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.

But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.

After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.

In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.

Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”

In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.

“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.

For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.

“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”

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

More than two dozen patient advocacy organizations have raised alarms about a recent court ruling that could threaten patient access to no-cost preventive screenings, including cancer screenings.

In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”

The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).

Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.

The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.

But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.

After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.

In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.

Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”

In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.

“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.

For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.

“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”

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

Long-awaited global transgender care guidelines have dropped, with no recommendations regarding age limits for treatment and surgery in teenagers but acknowledging the complexity of dealing with such adolescents amid lack of longitudinal research on the impact of transitioning gender.

The World Professional Association of Transgender Health published its latest standards of care (SOC8) as it opens its annual meeting on Sept. 16 in Montreal.

Origovisualis/Getty Images

These are “the most comprehensive set of guidelines ever produced to assist health care professionals around the world in support of transgender and gender diverse adults, adolescents, and children who are taking steps to live their lives authentically,” wrote WPATH President Walter Bouman, MD, PhD, and WPATH President-Elect Marci Bowers, MD, in a news release.

The SOC8 is the first update to guidance on the treatment of transgender individuals in 10 years and appears online in the International Journal of Transgender Health.

For the first time, the association wrote a chapter dedicated to transgender and gender-diverse adolescents – distinct from the child chapter.
 

The complexity of treating adolescents

WPATH officials said that this was owed to exponential growth in adolescent referral rates, more research on adolescent gender diversity–related care, and the unique developmental and care issues of this age group.

Until recently, there was limited information regarding the prevalence of gender diversity among adolescents. Studies from high-school samples indicate much higher rates than was earlier thought, with reports of up to 1.2% of participants identifying as transgender and up to 2.7% or more (for example, 7%-9%) experiencing some level of self-reported gender diversity, WPATH said.

The new chapter “applies to adolescents from the start of puberty until the legal age of majority (in most cases 18 years),” it stated.

However, WPATH did not go as far as to recommend lowering the age at which youth can receive cross-sex hormone therapy or gender-affirming surgeries, as earlier decreed in a draft of the guidelines. That draft suggested that young people could receive hormone therapy at age 14 years and surgeries for double mastectomies at age 15 years and for genital reassignment at age 17 years.

The exception was phalloplasty – surgery to construct a penis in female-to-male individuals – which WPATH stressed should not be performed under the age of 18 years owing to its complexity.

Now, the final SOC8 emphasizes that each transgender adolescent is unique, and decisions must be made on an individual basis, with no recommendations on specific ages for any treatment. This could be interpreted in many ways.

The SOC8 also acknowledges the “very rare” regret of individuals who have transitioned to the opposite gender and then changed their minds.

“[Health care] providers may consider the possibility an adolescent may regret gender-affirming decisions made during adolescence, and a young person will want to stop treatment and return to living in the birth-assigned gender role in the future. Providers may discuss this topic in a collaborative and trusting manner with the adolescent and their parents/caregivers before gender-affirming medical treatments are started,” it states.

WPATH, in addition, stressed the importance of counseling and supporting regretting patients, many who “expressed difficulties finding help during their detransition process and reported their detransition was an isolating experience during which they did not receive either sufficient or appropriate support.”

Although it doesn’t put a firm figure on the rate of regret overall, in its chapter on surgery, WPATH estimates that 0.3%-3.8% of transgender individuals regret gender-affirming surgery.

SOC8 also acknowledges “A pattern of uneven ratios by assigned sex has been reported in gender clinics, with assigned female-at-birth patients initiating care 2.5-7.1 times more frequently” than patients who were assigned male at birth.

And WPATH states in SOC8 that another phenomenon is the growing number of adolescents seeking care who had not previously experienced or expressed gender diversity during their childhood years.

It goes on to cite the 2018 paper of Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research. Dr. Littman coined the term, “rapid-onset gender dysphoria” to describe this phenomenon; SOC8 refrains from using this phrase, but does acknowledge: “For a select subgroup of young people, susceptibility to social influence impacting gender may be an important differential to consider.”

SOC8 recommends that before any medical or surgical treatment is considered, health care professionals “undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical/surgical transition-related care.”

And it specifically mentions that transgender adolescents “show high rates of autism spectrum disorder/characteristics,” and notes that “other neurodevelopmental presentations and/or mental health challenges may also be present, (e.g., ADHD, intellectual disability, and psychotic disorders).”

Who uses WPATH to guide care? This is ‘a big unknown’

WPATH is an umbrella organization with offshoots in most Western nations, such as USPATH in the United States, EPATH in Europe, and AUSPATH and NZPATH in Australia and New Zealand.

However, it is not the only organization to issue guidance on the care of transgender individuals; several specialties take care of this patient population, including, but not limited to: pediatricians, endocrinologists, psychiatrists, psychologists and plastic surgeons.

The extent to which any health care professional, or professional body, follows WPATH guidance is extremely varied.

“There is nothing binding clinicians to the SOC, and the SOC is so broad and vague that anyone can say they’re following it but according to their own biases and interpretation,” Aaron Kimberly, a trans man and mental health clinician from the Gender Dysphoria Alliance, said in an interview.

In North America, some clinics practice full “informed consent” with no assessment and prescriptions at the first visit, Mr. Kimberly said, whereas others do comprehensive assessments.

“I think SOC should be observed. It shouldn’t just be people going rogue,” Erica Anderson, a clinical psychologist in Berkeley, Calif., former president of USPATH, and former member of WPATH, who is herself transgender, said in an interview. “The reason there are standards of care is because hundreds of scientists have weighed in – is it perfect? No. We have a long way to go. But you can’t just ignore whatever it is that we know and let people make their own decisions.”

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

Long-awaited global transgender care guidelines have dropped, with no recommendations regarding age limits for treatment and surgery in teenagers but acknowledging the complexity of dealing with such adolescents amid lack of longitudinal research on the impact of transitioning gender.

The World Professional Association of Transgender Health published its latest standards of care (SOC8) as it opens its annual meeting on Sept. 16 in Montreal.

Origovisualis/Getty Images

These are “the most comprehensive set of guidelines ever produced to assist health care professionals around the world in support of transgender and gender diverse adults, adolescents, and children who are taking steps to live their lives authentically,” wrote WPATH President Walter Bouman, MD, PhD, and WPATH President-Elect Marci Bowers, MD, in a news release.

The SOC8 is the first update to guidance on the treatment of transgender individuals in 10 years and appears online in the International Journal of Transgender Health.

For the first time, the association wrote a chapter dedicated to transgender and gender-diverse adolescents – distinct from the child chapter.
 

The complexity of treating adolescents

WPATH officials said that this was owed to exponential growth in adolescent referral rates, more research on adolescent gender diversity–related care, and the unique developmental and care issues of this age group.

Until recently, there was limited information regarding the prevalence of gender diversity among adolescents. Studies from high-school samples indicate much higher rates than was earlier thought, with reports of up to 1.2% of participants identifying as transgender and up to 2.7% or more (for example, 7%-9%) experiencing some level of self-reported gender diversity, WPATH said.

The new chapter “applies to adolescents from the start of puberty until the legal age of majority (in most cases 18 years),” it stated.

However, WPATH did not go as far as to recommend lowering the age at which youth can receive cross-sex hormone therapy or gender-affirming surgeries, as earlier decreed in a draft of the guidelines. That draft suggested that young people could receive hormone therapy at age 14 years and surgeries for double mastectomies at age 15 years and for genital reassignment at age 17 years.

The exception was phalloplasty – surgery to construct a penis in female-to-male individuals – which WPATH stressed should not be performed under the age of 18 years owing to its complexity.

Now, the final SOC8 emphasizes that each transgender adolescent is unique, and decisions must be made on an individual basis, with no recommendations on specific ages for any treatment. This could be interpreted in many ways.

The SOC8 also acknowledges the “very rare” regret of individuals who have transitioned to the opposite gender and then changed their minds.

“[Health care] providers may consider the possibility an adolescent may regret gender-affirming decisions made during adolescence, and a young person will want to stop treatment and return to living in the birth-assigned gender role in the future. Providers may discuss this topic in a collaborative and trusting manner with the adolescent and their parents/caregivers before gender-affirming medical treatments are started,” it states.

WPATH, in addition, stressed the importance of counseling and supporting regretting patients, many who “expressed difficulties finding help during their detransition process and reported their detransition was an isolating experience during which they did not receive either sufficient or appropriate support.”

Although it doesn’t put a firm figure on the rate of regret overall, in its chapter on surgery, WPATH estimates that 0.3%-3.8% of transgender individuals regret gender-affirming surgery.

SOC8 also acknowledges “A pattern of uneven ratios by assigned sex has been reported in gender clinics, with assigned female-at-birth patients initiating care 2.5-7.1 times more frequently” than patients who were assigned male at birth.

And WPATH states in SOC8 that another phenomenon is the growing number of adolescents seeking care who had not previously experienced or expressed gender diversity during their childhood years.

It goes on to cite the 2018 paper of Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research. Dr. Littman coined the term, “rapid-onset gender dysphoria” to describe this phenomenon; SOC8 refrains from using this phrase, but does acknowledge: “For a select subgroup of young people, susceptibility to social influence impacting gender may be an important differential to consider.”

SOC8 recommends that before any medical or surgical treatment is considered, health care professionals “undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical/surgical transition-related care.”

And it specifically mentions that transgender adolescents “show high rates of autism spectrum disorder/characteristics,” and notes that “other neurodevelopmental presentations and/or mental health challenges may also be present, (e.g., ADHD, intellectual disability, and psychotic disorders).”

Who uses WPATH to guide care? This is ‘a big unknown’

WPATH is an umbrella organization with offshoots in most Western nations, such as USPATH in the United States, EPATH in Europe, and AUSPATH and NZPATH in Australia and New Zealand.

However, it is not the only organization to issue guidance on the care of transgender individuals; several specialties take care of this patient population, including, but not limited to: pediatricians, endocrinologists, psychiatrists, psychologists and plastic surgeons.

The extent to which any health care professional, or professional body, follows WPATH guidance is extremely varied.

“There is nothing binding clinicians to the SOC, and the SOC is so broad and vague that anyone can say they’re following it but according to their own biases and interpretation,” Aaron Kimberly, a trans man and mental health clinician from the Gender Dysphoria Alliance, said in an interview.

In North America, some clinics practice full “informed consent” with no assessment and prescriptions at the first visit, Mr. Kimberly said, whereas others do comprehensive assessments.

“I think SOC should be observed. It shouldn’t just be people going rogue,” Erica Anderson, a clinical psychologist in Berkeley, Calif., former president of USPATH, and former member of WPATH, who is herself transgender, said in an interview. “The reason there are standards of care is because hundreds of scientists have weighed in – is it perfect? No. We have a long way to go. But you can’t just ignore whatever it is that we know and let people make their own decisions.”

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

Long-awaited global transgender care guidelines have dropped, with no recommendations regarding age limits for treatment and surgery in teenagers but acknowledging the complexity of dealing with such adolescents amid lack of longitudinal research on the impact of transitioning gender.

The World Professional Association of Transgender Health published its latest standards of care (SOC8) as it opens its annual meeting on Sept. 16 in Montreal.

Origovisualis/Getty Images

These are “the most comprehensive set of guidelines ever produced to assist health care professionals around the world in support of transgender and gender diverse adults, adolescents, and children who are taking steps to live their lives authentically,” wrote WPATH President Walter Bouman, MD, PhD, and WPATH President-Elect Marci Bowers, MD, in a news release.

The SOC8 is the first update to guidance on the treatment of transgender individuals in 10 years and appears online in the International Journal of Transgender Health.

For the first time, the association wrote a chapter dedicated to transgender and gender-diverse adolescents – distinct from the child chapter.
 

The complexity of treating adolescents

WPATH officials said that this was owed to exponential growth in adolescent referral rates, more research on adolescent gender diversity–related care, and the unique developmental and care issues of this age group.

Until recently, there was limited information regarding the prevalence of gender diversity among adolescents. Studies from high-school samples indicate much higher rates than was earlier thought, with reports of up to 1.2% of participants identifying as transgender and up to 2.7% or more (for example, 7%-9%) experiencing some level of self-reported gender diversity, WPATH said.

The new chapter “applies to adolescents from the start of puberty until the legal age of majority (in most cases 18 years),” it stated.

However, WPATH did not go as far as to recommend lowering the age at which youth can receive cross-sex hormone therapy or gender-affirming surgeries, as earlier decreed in a draft of the guidelines. That draft suggested that young people could receive hormone therapy at age 14 years and surgeries for double mastectomies at age 15 years and for genital reassignment at age 17 years.

The exception was phalloplasty – surgery to construct a penis in female-to-male individuals – which WPATH stressed should not be performed under the age of 18 years owing to its complexity.

Now, the final SOC8 emphasizes that each transgender adolescent is unique, and decisions must be made on an individual basis, with no recommendations on specific ages for any treatment. This could be interpreted in many ways.

The SOC8 also acknowledges the “very rare” regret of individuals who have transitioned to the opposite gender and then changed their minds.

“[Health care] providers may consider the possibility an adolescent may regret gender-affirming decisions made during adolescence, and a young person will want to stop treatment and return to living in the birth-assigned gender role in the future. Providers may discuss this topic in a collaborative and trusting manner with the adolescent and their parents/caregivers before gender-affirming medical treatments are started,” it states.

WPATH, in addition, stressed the importance of counseling and supporting regretting patients, many who “expressed difficulties finding help during their detransition process and reported their detransition was an isolating experience during which they did not receive either sufficient or appropriate support.”

Although it doesn’t put a firm figure on the rate of regret overall, in its chapter on surgery, WPATH estimates that 0.3%-3.8% of transgender individuals regret gender-affirming surgery.

SOC8 also acknowledges “A pattern of uneven ratios by assigned sex has been reported in gender clinics, with assigned female-at-birth patients initiating care 2.5-7.1 times more frequently” than patients who were assigned male at birth.

And WPATH states in SOC8 that another phenomenon is the growing number of adolescents seeking care who had not previously experienced or expressed gender diversity during their childhood years.

It goes on to cite the 2018 paper of Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research. Dr. Littman coined the term, “rapid-onset gender dysphoria” to describe this phenomenon; SOC8 refrains from using this phrase, but does acknowledge: “For a select subgroup of young people, susceptibility to social influence impacting gender may be an important differential to consider.”

SOC8 recommends that before any medical or surgical treatment is considered, health care professionals “undertake a comprehensive biopsychosocial assessment of adolescents who present with gender identity-related concerns and seek medical/surgical transition-related care.”

And it specifically mentions that transgender adolescents “show high rates of autism spectrum disorder/characteristics,” and notes that “other neurodevelopmental presentations and/or mental health challenges may also be present, (e.g., ADHD, intellectual disability, and psychotic disorders).”

Who uses WPATH to guide care? This is ‘a big unknown’

WPATH is an umbrella organization with offshoots in most Western nations, such as USPATH in the United States, EPATH in Europe, and AUSPATH and NZPATH in Australia and New Zealand.

However, it is not the only organization to issue guidance on the care of transgender individuals; several specialties take care of this patient population, including, but not limited to: pediatricians, endocrinologists, psychiatrists, psychologists and plastic surgeons.

The extent to which any health care professional, or professional body, follows WPATH guidance is extremely varied.

“There is nothing binding clinicians to the SOC, and the SOC is so broad and vague that anyone can say they’re following it but according to their own biases and interpretation,” Aaron Kimberly, a trans man and mental health clinician from the Gender Dysphoria Alliance, said in an interview.

In North America, some clinics practice full “informed consent” with no assessment and prescriptions at the first visit, Mr. Kimberly said, whereas others do comprehensive assessments.

“I think SOC should be observed. It shouldn’t just be people going rogue,” Erica Anderson, a clinical psychologist in Berkeley, Calif., former president of USPATH, and former member of WPATH, who is herself transgender, said in an interview. “The reason there are standards of care is because hundreds of scientists have weighed in – is it perfect? No. We have a long way to go. But you can’t just ignore whatever it is that we know and let people make their own decisions.”

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

There’s big buzz about the hot prospects for blood tests designed to detect multiple kinds of cancer. President Biden highlighted them in a speech about the Cancer Moonshot program on Sept. 12, just a day after study results touted an experimental test’s ability to detect dozens of kinds of cancer. Meanwhile, the federal government is heralding an upcoming trial that will eventually enroll as many as 225,000 subjects.

There are plenty of reasons to be cautious, however. While the future looks promising, experts say that much more research is needed into multicancer early-detection assays. And if these tests become standard, the oncology field will need to figure out how to navigate a thicket of new challenges.

“Our friends in internal medicine and primary care will be looking to us for guidance. We need to make sure that we’re coming at this without too much optimism before we really have the data,” said Jyoti D. Patel, MD, medical director of thoracic oncology and assistant director for clinical research at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago.

Dr. Patel is a member of the communications workgroup of the Multicancer Early Detection Consortium, a nonprofit, public-private organization that’s providing insight and guidance into the development of screening tests. The consortium published a position paper earlier this year.

According to Dr. Patel, early cancer screening today can detect only five types of cancer: prostate, breast, lung, cervical, and colon. The Cancer Moonshot program has prioritized research into greatly expanding this number. President Biden referred to this goal in his Sept. 12 speech: “Imagine a simple blood test during an annual physical that could detect cancer early, where the chances of a cure are best.”

Biden said the National Cancer Institute is launching a major trial as part of the Cancer Moonshot program. The Vanguard Study on Multi-Cancer Detection plans to enlist 25,000 healthy women and men between 45 and 70 years old in 2024, then later enroll as many as 225,000 people.

Meanwhile, researchers reported on Sept. 11 that the Galleri multicancer detection blood test found positive cancer signals in 1.4% of 6,621 healthy subjects, and cancer was ultimately confirmed in 38% of those in that group. Nineteen solid tumors and 17 hematologic cancers were diagnosed; 26 of these were cancer types that don’t have routine screening available.

The Galleri test is widely available in the United States, although the $950 cost is not covered by insurance.

While the data is exciting, the high false-positive rate is worrisome, Dr. Patel said. “Are there ways that we can further define that by cancer-risk assessment or by having better captures in our technology that reflect RNA methylation or epigenetic changes that may lead to susceptibility to cancers?”
 

Additional research is essential

Ernest Hawk, MD, vice president and division head of cancer prevention and population sciences at the University of Texas MD Anderson Cancer Center, Houston, said it’s “absolutely essential” that research into screening tests clearly demonstrates improved patient outcomes over time.

“We need to have much longer follow-up of all participants – whether the screening results are positive or negative – and mitigate the potential risks of such testing,” said Dr. Hawk, who’s worked with the Multicancer Early Detection Consortium.

On another front, Northwestern University’s Dr. Patel highlighted that while easy-to-access cancer screening could create tremendous opportunities to treat early cancer and shrink disparities in care, it may produce “an onslaught of patients with early-stage disease. Do we have the workforce to help us?” Also, she said, “if we find a patient with early-stage disease, how are we going to risk-stratify their follow-up and adjuvant therapy? Are there ways to prognosticate with more granularity than we do now?”

What’s next? “Multicancer early-detection tests could truly revolutionize cancer care if they work as we hope they will, but only time, extensive participation in research, and hard work will prove whether that is true or not,” said MD Anderson’s Dr. Hawk. “I anticipate that we’ll have reasonable answers within the next decade, given the pace of existing company-sponsored research and NCI’s planned involvement in testing various technologies available.”

For her part, Dr. Patel said oncologists should be aware that multicancer screening tests are available and be ready to address questions about them. “Think about how you can advise patients in the absence of data,” she said.

Dr. Patel and Dr. Hawk have no relevant disclosures.

There’s big buzz about the hot prospects for blood tests designed to detect multiple kinds of cancer. President Biden highlighted them in a speech about the Cancer Moonshot program on Sept. 12, just a day after study results touted an experimental test’s ability to detect dozens of kinds of cancer. Meanwhile, the federal government is heralding an upcoming trial that will eventually enroll as many as 225,000 subjects.

There are plenty of reasons to be cautious, however. While the future looks promising, experts say that much more research is needed into multicancer early-detection assays. And if these tests become standard, the oncology field will need to figure out how to navigate a thicket of new challenges.

“Our friends in internal medicine and primary care will be looking to us for guidance. We need to make sure that we’re coming at this without too much optimism before we really have the data,” said Jyoti D. Patel, MD, medical director of thoracic oncology and assistant director for clinical research at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago.

Dr. Patel is a member of the communications workgroup of the Multicancer Early Detection Consortium, a nonprofit, public-private organization that’s providing insight and guidance into the development of screening tests. The consortium published a position paper earlier this year.

According to Dr. Patel, early cancer screening today can detect only five types of cancer: prostate, breast, lung, cervical, and colon. The Cancer Moonshot program has prioritized research into greatly expanding this number. President Biden referred to this goal in his Sept. 12 speech: “Imagine a simple blood test during an annual physical that could detect cancer early, where the chances of a cure are best.”

Biden said the National Cancer Institute is launching a major trial as part of the Cancer Moonshot program. The Vanguard Study on Multi-Cancer Detection plans to enlist 25,000 healthy women and men between 45 and 70 years old in 2024, then later enroll as many as 225,000 people.

Meanwhile, researchers reported on Sept. 11 that the Galleri multicancer detection blood test found positive cancer signals in 1.4% of 6,621 healthy subjects, and cancer was ultimately confirmed in 38% of those in that group. Nineteen solid tumors and 17 hematologic cancers were diagnosed; 26 of these were cancer types that don’t have routine screening available.

The Galleri test is widely available in the United States, although the $950 cost is not covered by insurance.

While the data is exciting, the high false-positive rate is worrisome, Dr. Patel said. “Are there ways that we can further define that by cancer-risk assessment or by having better captures in our technology that reflect RNA methylation or epigenetic changes that may lead to susceptibility to cancers?”
 

Additional research is essential

Ernest Hawk, MD, vice president and division head of cancer prevention and population sciences at the University of Texas MD Anderson Cancer Center, Houston, said it’s “absolutely essential” that research into screening tests clearly demonstrates improved patient outcomes over time.

“We need to have much longer follow-up of all participants – whether the screening results are positive or negative – and mitigate the potential risks of such testing,” said Dr. Hawk, who’s worked with the Multicancer Early Detection Consortium.

On another front, Northwestern University’s Dr. Patel highlighted that while easy-to-access cancer screening could create tremendous opportunities to treat early cancer and shrink disparities in care, it may produce “an onslaught of patients with early-stage disease. Do we have the workforce to help us?” Also, she said, “if we find a patient with early-stage disease, how are we going to risk-stratify their follow-up and adjuvant therapy? Are there ways to prognosticate with more granularity than we do now?”

What’s next? “Multicancer early-detection tests could truly revolutionize cancer care if they work as we hope they will, but only time, extensive participation in research, and hard work will prove whether that is true or not,” said MD Anderson’s Dr. Hawk. “I anticipate that we’ll have reasonable answers within the next decade, given the pace of existing company-sponsored research and NCI’s planned involvement in testing various technologies available.”

For her part, Dr. Patel said oncologists should be aware that multicancer screening tests are available and be ready to address questions about them. “Think about how you can advise patients in the absence of data,” she said.

Dr. Patel and Dr. Hawk have no relevant disclosures.

There’s big buzz about the hot prospects for blood tests designed to detect multiple kinds of cancer. President Biden highlighted them in a speech about the Cancer Moonshot program on Sept. 12, just a day after study results touted an experimental test’s ability to detect dozens of kinds of cancer. Meanwhile, the federal government is heralding an upcoming trial that will eventually enroll as many as 225,000 subjects.

There are plenty of reasons to be cautious, however. While the future looks promising, experts say that much more research is needed into multicancer early-detection assays. And if these tests become standard, the oncology field will need to figure out how to navigate a thicket of new challenges.

“Our friends in internal medicine and primary care will be looking to us for guidance. We need to make sure that we’re coming at this without too much optimism before we really have the data,” said Jyoti D. Patel, MD, medical director of thoracic oncology and assistant director for clinical research at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago.

Dr. Patel is a member of the communications workgroup of the Multicancer Early Detection Consortium, a nonprofit, public-private organization that’s providing insight and guidance into the development of screening tests. The consortium published a position paper earlier this year.

According to Dr. Patel, early cancer screening today can detect only five types of cancer: prostate, breast, lung, cervical, and colon. The Cancer Moonshot program has prioritized research into greatly expanding this number. President Biden referred to this goal in his Sept. 12 speech: “Imagine a simple blood test during an annual physical that could detect cancer early, where the chances of a cure are best.”

Biden said the National Cancer Institute is launching a major trial as part of the Cancer Moonshot program. The Vanguard Study on Multi-Cancer Detection plans to enlist 25,000 healthy women and men between 45 and 70 years old in 2024, then later enroll as many as 225,000 people.

Meanwhile, researchers reported on Sept. 11 that the Galleri multicancer detection blood test found positive cancer signals in 1.4% of 6,621 healthy subjects, and cancer was ultimately confirmed in 38% of those in that group. Nineteen solid tumors and 17 hematologic cancers were diagnosed; 26 of these were cancer types that don’t have routine screening available.

The Galleri test is widely available in the United States, although the $950 cost is not covered by insurance.

While the data is exciting, the high false-positive rate is worrisome, Dr. Patel said. “Are there ways that we can further define that by cancer-risk assessment or by having better captures in our technology that reflect RNA methylation or epigenetic changes that may lead to susceptibility to cancers?”
 

Additional research is essential

Ernest Hawk, MD, vice president and division head of cancer prevention and population sciences at the University of Texas MD Anderson Cancer Center, Houston, said it’s “absolutely essential” that research into screening tests clearly demonstrates improved patient outcomes over time.

“We need to have much longer follow-up of all participants – whether the screening results are positive or negative – and mitigate the potential risks of such testing,” said Dr. Hawk, who’s worked with the Multicancer Early Detection Consortium.

On another front, Northwestern University’s Dr. Patel highlighted that while easy-to-access cancer screening could create tremendous opportunities to treat early cancer and shrink disparities in care, it may produce “an onslaught of patients with early-stage disease. Do we have the workforce to help us?” Also, she said, “if we find a patient with early-stage disease, how are we going to risk-stratify their follow-up and adjuvant therapy? Are there ways to prognosticate with more granularity than we do now?”

What’s next? “Multicancer early-detection tests could truly revolutionize cancer care if they work as we hope they will, but only time, extensive participation in research, and hard work will prove whether that is true or not,” said MD Anderson’s Dr. Hawk. “I anticipate that we’ll have reasonable answers within the next decade, given the pace of existing company-sponsored research and NCI’s planned involvement in testing various technologies available.”

For her part, Dr. Patel said oncologists should be aware that multicancer screening tests are available and be ready to address questions about them. “Think about how you can advise patients in the absence of data,” she said.

Dr. Patel and Dr. Hawk have no relevant disclosures.

As reproductive specialists, part of our obligation is to improve a woman’s or couple’s ability to conceive in the most cost-effective manner, ideally through natural attempts at conception. While assisted reproductive technologies (ART) have provided impressive pregnancy rates across many diagnoses, including unexplained infertility, this advanced procedure comes with a significant financial cost to those without insurance and an emotional burden from the lack of a guaranteed outcome. Infertility procedures have minimal associated but potentially significant risks, most importantly multiple gestations. Contrary to popular belief, ovulation induction with intrauterine insemination (IUI) treatment has a greater risk of high-order multiple gestation when compared with IVF, given the inability of the former to control the number of embryos that may enter and implant in the endometrial cavity and the increased use of single embryo transfers with the latter. The specialist should evaluate the woman or couple for the basic issues of ovulation, tubal, and sperm function, as well as for lifestyle and environmental factors that can impede reproduction. As a result, “one size fits all” should not apply to patients, specifically those with infertility. This month’s column will present the detrimental effect of environmental and lifestyle factors on the goal of enhancing fertility through natural cycles of urine luteinizing-hormone timed intercourse.

Nutrition

Often overlooked in the infertility evaluation, an optimal diet improves fertility for both partners. Processed meat has been associated with reduced sperm quality. In ART, red meat has been associated with decreased embryo blastocyst formation. Lower trans fatty acids and higher omega-3s may improve fecundity. Considered one of the best overall diets, the Mediterranean diet consists of plant-based foods, such as whole grains, vegetables, legumes, fruits, nuts, seeds, herbs, and spices. Olive oil is the main source of added fat whereas fish, seafood, dairy, and poultry should be eaten in moderation. Fatty fish, such as mackerel, herring, sardines, albacore tuna, and salmon, are rich in omega-3 fatty acids, which have been shown to improve fecundity and IVF success, and have a positive association with blastocyst embryo development.^1-3

Stress

The emotional effect of an infertility diagnosis has been demonstrated to be equivalent to a diagnosis of cancer and other major medical morbidities.⁴ Whether stress causes or is a result of infertility has been a longstanding debate.⁵ Nevertheless, stress is the number-one reason patients discontinue fertility treatment.⁶ As fertility specialists, we must be cognizant of the devastation endured by infertility patients and maintain an open dialogue, as well as provide resources for coping strategies and counseling.

One popular method of improving mental health and fertility has been acupuncture. Initial enthusiasm originated from one of the first studies to explore the use of acupuncture during IVF. This was a prospective randomized study that showed treated patients had an approximately 100% improvement in clinical pregnancy rate. Unfortunately, there was no appropriate control group, just untreated controls.⁷ A subsequent study by the same investigator added a placebo acupuncture control group and did not show a statistically significant increase in pregnancy rates.⁸ Finally, a meta-analysis and reanalysis did not demonstrate any improvement in pregnancy outcome, whereas three of the studies analyzed suggested a possible reduction in pregnancies; placebo acupuncture was shown to have a higher success rate.^9-11 While acupuncture is relatively safe, there appears to be only a placebo effect that may be helpful.

The effect of stress on reproduction has been addressed in one of my previous columns.
 

Alcohol and caffeine

The damaging effects of alcohol on the fetus during pregnancy are legion – abnormal facial features, microcephaly, low birth weight, hyperactive behavior, vision or hearing deficits, speech and language delays, and intellectual disability. Less known is the amount of alcohol that may have an effect during preconception. One of the first reports on the effect of alcohol on IVF concluded: a 13% decrease in the number of eggs aspirated; a 2.86 times increase in risk of not achieving pregnancy; and a 2.21 times increase in risk of miscarriage. For men, one additional drink per day increased the risk of not achieving a live birth from 2.28 to 8.32 times.¹² Subsequent studies demonstrate a 16% reduction in IVF pregnancies in women who have at least four drinks per week; when the couple drank at least four drinks per week, the pregnancy rate decreased by 21%.¹³

However, a study from Denmark did not demonstrate a negative effect of low to moderate pretreatment amounts of alcohol and caffeine on IVF outcomes.¹⁴ Nevertheless, there is evidence that reducing or abstaining from alcohol intake may improve IVF outcomes.¹⁵ While there have been reports of higher miscarriage rates from caffeine,^16,17 not all reports support a negative association.¹⁸

Smoking

The use of tobacco has been estimated to contribute to 13% of female infertility in a dose-response manner, including secondhand smoke. During ART, smoking reduces ovarian response to gonadotropins and decreases IVF success by up to 50%. Discontinuing smoking for 6 months beforehand appears to restore normal outcomes.^19-20

The American Society for Reproductive Medicine Practice Committee on smoking provides the following invaluable information to share with patients on the harmful reproductive effects of smoking:²¹

• Early menopause by accelerating the loss of eggs.
• Higher rates of miscarriage and ectopic pregnancy.
• A decrease in sperm function.
• Possible genetic damage to eggs and sperm.
• Reduced sperm in son from maternal smoking.

Weight and exercise

Compared with normal-weight women, those with obesity are three times more likely to have ovulatory dysfunction;²² a lower chance for conception;²³ and infertility.²⁴ Obese women have higher rates of miscarriage and recurrent miscarriage, reduced success with ART, an increased number of canceled cycles, and poorer quality oocytes retrieved. During pregnancy, obese women have three to four times higher rates of gestational diabetes and preeclampsia,²⁵ as well as likelihood of having a fetus with macrosomia and birth defects, and a 1.3-2.1 times higher risk of stillbirth.²⁶

Regarding physical activity, the rate of pregnancies (39.0% vs. 16.0%, P = .002) and live births (24.4% vs. 7.4% (P = .004) were higher with regular exercise vs. being sedentary. Obese women who exercised regularly had a live birth rate over threefold higher compared with those who were not active.²⁷ Moderation should be employed given that women who exercise to exhaustion have 2.3 times the odds of fertility problems.²⁸ In men, obesity has been shown to increase estrogens and reduce spermatogenesis. Exercise has improved semen parameters and testosterone. Paternal physical and sedentary activities were not related to clinical pregnancy or live birth rates following infertility treatment.²⁹ As in women, men experience negative effects from high-intensity exercise, including bicycling, which can result in decreased semen parameters, follicle-stimulating hormone, LH, and testosterone levels.³⁰

In couples desiring a more natural approach to infertility, fertility specialists can address environmental and lifestyle factors that may improve reproduction. When natural attempts at conception are not applicable or successful, IUI and ART are appropriate treatment options after considering estimated success rates as well as the physical, emotional, and financial investment of patients.

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.
 

References

1. Wise LA et al. Am J Epidemiol. 2018;187:60-74.

2. Chui Y-H. Hum Reprod. 2018;33:156-65.

3. Ferreira Braga DPA et al. Reprod Biomed Online. 2015;31:30-8.

4. Domar AD et al. J Psychosom Obstet Gynaecol. 1993;14[suppl]:45-52.

5. Trolice MP. J Assist Reprod Genet. 2021 Apr;38[4]:873-5.

6. Gameiro S et al. Hum Reprod Update. 2012;18[6]:652-69.

7. Paulus WE et al. Fertil Steril. 2002;77:721-4.

8. Paulus WE et al. Hum Reprod. 2003;18:S18(abstr).

9. Wing SSE et al. Hum Reprod. 2009;24:341-8.

10. Hong Zheng C et al. Fertil Steril. 2012;97:599-611.

11. Meldrum DR et al. Fertil Steril. 2013;99:1821-4.

12. Klonoff-Cohen H et al. Fertil Steril. 2003;79:330-9.

13. Rossi BV et al. Obstet Gynecol. 2011;117:136-42.

14. Abadia L et al. Hum Reprod. 2017;32:1846-54.

15. Gormack AA et al. Hum Reprod. 2015;30:1617.

16. James JE. BMJ Evid Based Med. 2021;26:114-15.

17. Gaskins AJ et al. Eur J Nutr. 2018 Feb;57:107-17.

18. Machtinger R et al. Fertil Steril. 2017;108:1026-33.

19. Hughes EG et al. Fertil Steril. 1994;62:807.

20. de Ziegler D et al. Fertil Steril. 2013;100:927-8.

21. Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2018;110:611-8.

22. Brewer CJ, Balen AH. Reproduction. 2010;140:347-64.

23. Wise LA et al. Hum Reprod. 2010;25:253-64.

24. Silvestris S et al. Reprod Biol Endocrinol. 2018;16[1]:22.

25. Alwash SM et al. Obes Res Clin Pract. 2021;15:425-30.

26. Aune D et al. JAMA. 2014;311:1536-46.

27. Palomba S et al. Reprod Biomed Online. 2014;29:72-9.

28. Gudmundsdottir SL et al. Hum Reprod. 2009;24[12]:3196-204.

29. Gaskins AJ et al. Hum Reprod. 2014;29:2575-82.

30. Wise LA et al. Fertil Steril. 2011;95:1025-30.

As reproductive specialists, part of our obligation is to improve a woman’s or couple’s ability to conceive in the most cost-effective manner, ideally through natural attempts at conception. While assisted reproductive technologies (ART) have provided impressive pregnancy rates across many diagnoses, including unexplained infertility, this advanced procedure comes with a significant financial cost to those without insurance and an emotional burden from the lack of a guaranteed outcome. Infertility procedures have minimal associated but potentially significant risks, most importantly multiple gestations. Contrary to popular belief, ovulation induction with intrauterine insemination (IUI) treatment has a greater risk of high-order multiple gestation when compared with IVF, given the inability of the former to control the number of embryos that may enter and implant in the endometrial cavity and the increased use of single embryo transfers with the latter. The specialist should evaluate the woman or couple for the basic issues of ovulation, tubal, and sperm function, as well as for lifestyle and environmental factors that can impede reproduction. As a result, “one size fits all” should not apply to patients, specifically those with infertility. This month’s column will present the detrimental effect of environmental and lifestyle factors on the goal of enhancing fertility through natural cycles of urine luteinizing-hormone timed intercourse.

Nutrition

Often overlooked in the infertility evaluation, an optimal diet improves fertility for both partners. Processed meat has been associated with reduced sperm quality. In ART, red meat has been associated with decreased embryo blastocyst formation. Lower trans fatty acids and higher omega-3s may improve fecundity. Considered one of the best overall diets, the Mediterranean diet consists of plant-based foods, such as whole grains, vegetables, legumes, fruits, nuts, seeds, herbs, and spices. Olive oil is the main source of added fat whereas fish, seafood, dairy, and poultry should be eaten in moderation. Fatty fish, such as mackerel, herring, sardines, albacore tuna, and salmon, are rich in omega-3 fatty acids, which have been shown to improve fecundity and IVF success, and have a positive association with blastocyst embryo development.^1-3

Stress

The emotional effect of an infertility diagnosis has been demonstrated to be equivalent to a diagnosis of cancer and other major medical morbidities.⁴ Whether stress causes or is a result of infertility has been a longstanding debate.⁵ Nevertheless, stress is the number-one reason patients discontinue fertility treatment.⁶ As fertility specialists, we must be cognizant of the devastation endured by infertility patients and maintain an open dialogue, as well as provide resources for coping strategies and counseling.

One popular method of improving mental health and fertility has been acupuncture. Initial enthusiasm originated from one of the first studies to explore the use of acupuncture during IVF. This was a prospective randomized study that showed treated patients had an approximately 100% improvement in clinical pregnancy rate. Unfortunately, there was no appropriate control group, just untreated controls.⁷ A subsequent study by the same investigator added a placebo acupuncture control group and did not show a statistically significant increase in pregnancy rates.⁸ Finally, a meta-analysis and reanalysis did not demonstrate any improvement in pregnancy outcome, whereas three of the studies analyzed suggested a possible reduction in pregnancies; placebo acupuncture was shown to have a higher success rate.^9-11 While acupuncture is relatively safe, there appears to be only a placebo effect that may be helpful.

The effect of stress on reproduction has been addressed in one of my previous columns.
 

Alcohol and caffeine

The damaging effects of alcohol on the fetus during pregnancy are legion – abnormal facial features, microcephaly, low birth weight, hyperactive behavior, vision or hearing deficits, speech and language delays, and intellectual disability. Less known is the amount of alcohol that may have an effect during preconception. One of the first reports on the effect of alcohol on IVF concluded: a 13% decrease in the number of eggs aspirated; a 2.86 times increase in risk of not achieving pregnancy; and a 2.21 times increase in risk of miscarriage. For men, one additional drink per day increased the risk of not achieving a live birth from 2.28 to 8.32 times.¹² Subsequent studies demonstrate a 16% reduction in IVF pregnancies in women who have at least four drinks per week; when the couple drank at least four drinks per week, the pregnancy rate decreased by 21%.¹³

However, a study from Denmark did not demonstrate a negative effect of low to moderate pretreatment amounts of alcohol and caffeine on IVF outcomes.¹⁴ Nevertheless, there is evidence that reducing or abstaining from alcohol intake may improve IVF outcomes.¹⁵ While there have been reports of higher miscarriage rates from caffeine,^16,17 not all reports support a negative association.¹⁸

Smoking

The use of tobacco has been estimated to contribute to 13% of female infertility in a dose-response manner, including secondhand smoke. During ART, smoking reduces ovarian response to gonadotropins and decreases IVF success by up to 50%. Discontinuing smoking for 6 months beforehand appears to restore normal outcomes.^19-20

The American Society for Reproductive Medicine Practice Committee on smoking provides the following invaluable information to share with patients on the harmful reproductive effects of smoking:²¹

• Early menopause by accelerating the loss of eggs.
• Higher rates of miscarriage and ectopic pregnancy.
• A decrease in sperm function.
• Possible genetic damage to eggs and sperm.
• Reduced sperm in son from maternal smoking.

Weight and exercise

Compared with normal-weight women, those with obesity are three times more likely to have ovulatory dysfunction;²² a lower chance for conception;²³ and infertility.²⁴ Obese women have higher rates of miscarriage and recurrent miscarriage, reduced success with ART, an increased number of canceled cycles, and poorer quality oocytes retrieved. During pregnancy, obese women have three to four times higher rates of gestational diabetes and preeclampsia,²⁵ as well as likelihood of having a fetus with macrosomia and birth defects, and a 1.3-2.1 times higher risk of stillbirth.²⁶

Regarding physical activity, the rate of pregnancies (39.0% vs. 16.0%, P = .002) and live births (24.4% vs. 7.4% (P = .004) were higher with regular exercise vs. being sedentary. Obese women who exercised regularly had a live birth rate over threefold higher compared with those who were not active.²⁷ Moderation should be employed given that women who exercise to exhaustion have 2.3 times the odds of fertility problems.²⁸ In men, obesity has been shown to increase estrogens and reduce spermatogenesis. Exercise has improved semen parameters and testosterone. Paternal physical and sedentary activities were not related to clinical pregnancy or live birth rates following infertility treatment.²⁹ As in women, men experience negative effects from high-intensity exercise, including bicycling, which can result in decreased semen parameters, follicle-stimulating hormone, LH, and testosterone levels.³⁰

In couples desiring a more natural approach to infertility, fertility specialists can address environmental and lifestyle factors that may improve reproduction. When natural attempts at conception are not applicable or successful, IUI and ART are appropriate treatment options after considering estimated success rates as well as the physical, emotional, and financial investment of patients.

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.
 

References

1. Wise LA et al. Am J Epidemiol. 2018;187:60-74.

2. Chui Y-H. Hum Reprod. 2018;33:156-65.

3. Ferreira Braga DPA et al. Reprod Biomed Online. 2015;31:30-8.

4. Domar AD et al. J Psychosom Obstet Gynaecol. 1993;14[suppl]:45-52.

5. Trolice MP. J Assist Reprod Genet. 2021 Apr;38[4]:873-5.

6. Gameiro S et al. Hum Reprod Update. 2012;18[6]:652-69.

7. Paulus WE et al. Fertil Steril. 2002;77:721-4.

8. Paulus WE et al. Hum Reprod. 2003;18:S18(abstr).

9. Wing SSE et al. Hum Reprod. 2009;24:341-8.

10. Hong Zheng C et al. Fertil Steril. 2012;97:599-611.

11. Meldrum DR et al. Fertil Steril. 2013;99:1821-4.

12. Klonoff-Cohen H et al. Fertil Steril. 2003;79:330-9.

13. Rossi BV et al. Obstet Gynecol. 2011;117:136-42.

14. Abadia L et al. Hum Reprod. 2017;32:1846-54.

15. Gormack AA et al. Hum Reprod. 2015;30:1617.

16. James JE. BMJ Evid Based Med. 2021;26:114-15.

17. Gaskins AJ et al. Eur J Nutr. 2018 Feb;57:107-17.

18. Machtinger R et al. Fertil Steril. 2017;108:1026-33.

19. Hughes EG et al. Fertil Steril. 1994;62:807.

20. de Ziegler D et al. Fertil Steril. 2013;100:927-8.

21. Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2018;110:611-8.

22. Brewer CJ, Balen AH. Reproduction. 2010;140:347-64.

23. Wise LA et al. Hum Reprod. 2010;25:253-64.

24. Silvestris S et al. Reprod Biol Endocrinol. 2018;16[1]:22.

25. Alwash SM et al. Obes Res Clin Pract. 2021;15:425-30.

26. Aune D et al. JAMA. 2014;311:1536-46.

27. Palomba S et al. Reprod Biomed Online. 2014;29:72-9.

28. Gudmundsdottir SL et al. Hum Reprod. 2009;24[12]:3196-204.

29. Gaskins AJ et al. Hum Reprod. 2014;29:2575-82.

30. Wise LA et al. Fertil Steril. 2011;95:1025-30.

As reproductive specialists, part of our obligation is to improve a woman’s or couple’s ability to conceive in the most cost-effective manner, ideally through natural attempts at conception. While assisted reproductive technologies (ART) have provided impressive pregnancy rates across many diagnoses, including unexplained infertility, this advanced procedure comes with a significant financial cost to those without insurance and an emotional burden from the lack of a guaranteed outcome. Infertility procedures have minimal associated but potentially significant risks, most importantly multiple gestations. Contrary to popular belief, ovulation induction with intrauterine insemination (IUI) treatment has a greater risk of high-order multiple gestation when compared with IVF, given the inability of the former to control the number of embryos that may enter and implant in the endometrial cavity and the increased use of single embryo transfers with the latter. The specialist should evaluate the woman or couple for the basic issues of ovulation, tubal, and sperm function, as well as for lifestyle and environmental factors that can impede reproduction. As a result, “one size fits all” should not apply to patients, specifically those with infertility. This month’s column will present the detrimental effect of environmental and lifestyle factors on the goal of enhancing fertility through natural cycles of urine luteinizing-hormone timed intercourse.

Nutrition

Often overlooked in the infertility evaluation, an optimal diet improves fertility for both partners. Processed meat has been associated with reduced sperm quality. In ART, red meat has been associated with decreased embryo blastocyst formation. Lower trans fatty acids and higher omega-3s may improve fecundity. Considered one of the best overall diets, the Mediterranean diet consists of plant-based foods, such as whole grains, vegetables, legumes, fruits, nuts, seeds, herbs, and spices. Olive oil is the main source of added fat whereas fish, seafood, dairy, and poultry should be eaten in moderation. Fatty fish, such as mackerel, herring, sardines, albacore tuna, and salmon, are rich in omega-3 fatty acids, which have been shown to improve fecundity and IVF success, and have a positive association with blastocyst embryo development.^1-3

Stress

The emotional effect of an infertility diagnosis has been demonstrated to be equivalent to a diagnosis of cancer and other major medical morbidities.⁴ Whether stress causes or is a result of infertility has been a longstanding debate.⁵ Nevertheless, stress is the number-one reason patients discontinue fertility treatment.⁶ As fertility specialists, we must be cognizant of the devastation endured by infertility patients and maintain an open dialogue, as well as provide resources for coping strategies and counseling.

One popular method of improving mental health and fertility has been acupuncture. Initial enthusiasm originated from one of the first studies to explore the use of acupuncture during IVF. This was a prospective randomized study that showed treated patients had an approximately 100% improvement in clinical pregnancy rate. Unfortunately, there was no appropriate control group, just untreated controls.⁷ A subsequent study by the same investigator added a placebo acupuncture control group and did not show a statistically significant increase in pregnancy rates.⁸ Finally, a meta-analysis and reanalysis did not demonstrate any improvement in pregnancy outcome, whereas three of the studies analyzed suggested a possible reduction in pregnancies; placebo acupuncture was shown to have a higher success rate.^9-11 While acupuncture is relatively safe, there appears to be only a placebo effect that may be helpful.

The effect of stress on reproduction has been addressed in one of my previous columns.
 

Alcohol and caffeine

The damaging effects of alcohol on the fetus during pregnancy are legion – abnormal facial features, microcephaly, low birth weight, hyperactive behavior, vision or hearing deficits, speech and language delays, and intellectual disability. Less known is the amount of alcohol that may have an effect during preconception. One of the first reports on the effect of alcohol on IVF concluded: a 13% decrease in the number of eggs aspirated; a 2.86 times increase in risk of not achieving pregnancy; and a 2.21 times increase in risk of miscarriage. For men, one additional drink per day increased the risk of not achieving a live birth from 2.28 to 8.32 times.¹² Subsequent studies demonstrate a 16% reduction in IVF pregnancies in women who have at least four drinks per week; when the couple drank at least four drinks per week, the pregnancy rate decreased by 21%.¹³

However, a study from Denmark did not demonstrate a negative effect of low to moderate pretreatment amounts of alcohol and caffeine on IVF outcomes.¹⁴ Nevertheless, there is evidence that reducing or abstaining from alcohol intake may improve IVF outcomes.¹⁵ While there have been reports of higher miscarriage rates from caffeine,^16,17 not all reports support a negative association.¹⁸

Smoking

The use of tobacco has been estimated to contribute to 13% of female infertility in a dose-response manner, including secondhand smoke. During ART, smoking reduces ovarian response to gonadotropins and decreases IVF success by up to 50%. Discontinuing smoking for 6 months beforehand appears to restore normal outcomes.^19-20

The American Society for Reproductive Medicine Practice Committee on smoking provides the following invaluable information to share with patients on the harmful reproductive effects of smoking:²¹

• Early menopause by accelerating the loss of eggs.
• Higher rates of miscarriage and ectopic pregnancy.
• A decrease in sperm function.
• Possible genetic damage to eggs and sperm.
• Reduced sperm in son from maternal smoking.

Weight and exercise

Compared with normal-weight women, those with obesity are three times more likely to have ovulatory dysfunction;²² a lower chance for conception;²³ and infertility.²⁴ Obese women have higher rates of miscarriage and recurrent miscarriage, reduced success with ART, an increased number of canceled cycles, and poorer quality oocytes retrieved. During pregnancy, obese women have three to four times higher rates of gestational diabetes and preeclampsia,²⁵ as well as likelihood of having a fetus with macrosomia and birth defects, and a 1.3-2.1 times higher risk of stillbirth.²⁶

Regarding physical activity, the rate of pregnancies (39.0% vs. 16.0%, P = .002) and live births (24.4% vs. 7.4% (P = .004) were higher with regular exercise vs. being sedentary. Obese women who exercised regularly had a live birth rate over threefold higher compared with those who were not active.²⁷ Moderation should be employed given that women who exercise to exhaustion have 2.3 times the odds of fertility problems.²⁸ In men, obesity has been shown to increase estrogens and reduce spermatogenesis. Exercise has improved semen parameters and testosterone. Paternal physical and sedentary activities were not related to clinical pregnancy or live birth rates following infertility treatment.²⁹ As in women, men experience negative effects from high-intensity exercise, including bicycling, which can result in decreased semen parameters, follicle-stimulating hormone, LH, and testosterone levels.³⁰

In couples desiring a more natural approach to infertility, fertility specialists can address environmental and lifestyle factors that may improve reproduction. When natural attempts at conception are not applicable or successful, IUI and ART are appropriate treatment options after considering estimated success rates as well as the physical, emotional, and financial investment of patients.

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.
 

References

1. Wise LA et al. Am J Epidemiol. 2018;187:60-74.

2. Chui Y-H. Hum Reprod. 2018;33:156-65.

3. Ferreira Braga DPA et al. Reprod Biomed Online. 2015;31:30-8.

4. Domar AD et al. J Psychosom Obstet Gynaecol. 1993;14[suppl]:45-52.

5. Trolice MP. J Assist Reprod Genet. 2021 Apr;38[4]:873-5.

6. Gameiro S et al. Hum Reprod Update. 2012;18[6]:652-69.

7. Paulus WE et al. Fertil Steril. 2002;77:721-4.

8. Paulus WE et al. Hum Reprod. 2003;18:S18(abstr).

9. Wing SSE et al. Hum Reprod. 2009;24:341-8.

10. Hong Zheng C et al. Fertil Steril. 2012;97:599-611.

11. Meldrum DR et al. Fertil Steril. 2013;99:1821-4.

12. Klonoff-Cohen H et al. Fertil Steril. 2003;79:330-9.

13. Rossi BV et al. Obstet Gynecol. 2011;117:136-42.

14. Abadia L et al. Hum Reprod. 2017;32:1846-54.

15. Gormack AA et al. Hum Reprod. 2015;30:1617.

16. James JE. BMJ Evid Based Med. 2021;26:114-15.

17. Gaskins AJ et al. Eur J Nutr. 2018 Feb;57:107-17.

18. Machtinger R et al. Fertil Steril. 2017;108:1026-33.

19. Hughes EG et al. Fertil Steril. 1994;62:807.

20. de Ziegler D et al. Fertil Steril. 2013;100:927-8.

21. Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2018;110:611-8.

22. Brewer CJ, Balen AH. Reproduction. 2010;140:347-64.

23. Wise LA et al. Hum Reprod. 2010;25:253-64.

24. Silvestris S et al. Reprod Biol Endocrinol. 2018;16[1]:22.

25. Alwash SM et al. Obes Res Clin Pract. 2021;15:425-30.

26. Aune D et al. JAMA. 2014;311:1536-46.

27. Palomba S et al. Reprod Biomed Online. 2014;29:72-9.

28. Gudmundsdottir SL et al. Hum Reprod. 2009;24[12]:3196-204.

29. Gaskins AJ et al. Hum Reprod. 2014;29:2575-82.

30. Wise LA et al. Fertil Steril. 2011;95:1025-30.

Maya Iyer, MD, MEd, experienced bullying as a faculty member, and she sensed that she wasn’t alone. “The best ideas for research often come from individual experiences, in both personal and the professional academic medicine setting,” she said in an interview.

“And I was correct. I was not the only one who experienced bullying. In fact, the most severe bullying experiences among ... women physician leaders occurred when they were in leadership positions,” said Dr. Iyer, a pediatric emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

She is a coauthor of a study that was published in JAMA Network Open in which investigators surveyed the existence of antibullying policies for faculty at almost 100 U.S. medical schools.

The researchers defined bullying as “a severe form of mistreatment [that] occurs in the medical setting when a power differential allows offenders to consciously target individuals through persistent negative actions to impede the education or career of the target.”

The study included 91 medical schools, of which 4 schools had antibullying policies that included the reporting of procedures. Of the 87 medical schools without antibullying policies, 60 had antiharrassment policies; of those schools, 10 of the schools’ websites cited bullying and antiharassment policies. Five schools required a login to access policies, and one school’s website had a broken webpage link, per the study.

“We need to bring the silent scourge of bullying to the forefront because bullying is causing a brain drain on the medical profession,” said Dr. Iyer. “Bullying has numerous downstream negative effects, including depression, anxiety, burnout stress, decreased patient care satisfaction, increased medical errors, and job attrition.”

She added: “Through bullying, we are losing voices in medicine just at that point in time where we are trying to diversify the workforce to improve representation of all physicians.”

Dr. Iyer’s team sampled the top 25 schools for research and the top 25 schools for primary care. They also took a random sampling from 25 schools for research and a random sampling from top 25 schools for primary care. They assessed antibullying policies, antiharassment policies that mentioned bullying, antiharrassment policies that did not mention bullying, and the absence of policies addressing these issues.

Policy comprehensiveness was another focus for the researchers. They evaluated whether the relevant policies included faculty members and articulated the institution’s commitment to providing a safe and healthy workplace. Other factors included defining bullying and the roles and responsibilities of employees and procedures for reporting bullying.
 

Physicians can’t be bystanders to bullying

Dr. Iyer called on physicians to “acknowledge that bullying in academic medicine exists and [to] speak up when they witness such events. This means transitioning from being a bystander to an upstander.”

She doesn’t let medical schools off the hook, however. Instead, she advocated having institutions “provide safe spaces and opportunities for near-peer mentoring so that targets of bullying can share stories.”

Regarding who is responsible for addressing bullying, Dr. Iyer is emphatic. “I do want to be clear that the onus of disrupting does not fall on the targets. Rather, we need to fix the systems in which such behavior is tolerated.”

Her advice to leaders in academic medicine is to create comprehensive, zero-retaliation bullying policies that include detailed reporting procedures. Dr. Iyer advised leaders to partner with colleagues in human resources, offices of equity, and ombudspersons to develop, implement, and enforce these policies.

The study authors reported no conflicts of interest.

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