Randy Dotinga

SAN DIEGO – The end of the legal standards set by Roe v. Wade will likely lead to bans in as many as 26 states and send a flood of abortion seekers to the remaining states that still allow the procedure, an obstetrician-gynecologist warned colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“The blue states neighboring those states will likely see an outpouring of patients among those who can travel,” Kristyn Brandi, MD, of New Jersey Medical School, Newark, said in a presentation about legal threats to abortion rights. “These will likely flood the health care systems and delay care for everyone. Make no mistake: Virtually all ob.gyns. across the country have the potential to be impacted.”

Indeed, research suggests that thousands more Texans than usual are heading out of state for abortions each month in the wake of a new, strict antiabortion law there.

Only three sessions at the 3-day ACOG meeting directly addressed abortion. But the topic was clearly on the minds of attendees in the wake of the release of a leaked draft of a Supreme Court ruling that would eliminate federal protection for abortion rights.

The 57,000-member ACOG organization firmly supports abortion rights and declares on its website that “Abortion Is Healthcare.”

In a workshop on challenges to abortion, ACOG chief of staff Dorothea Calvano Lindquist said “we remain your steadfast partner in advocacy and guidance on all levels.”

Ivana S. Thompson, MD, an ob.gyn. at Vanderbilt University, Nashville, Tenn., explained in a presentation that Roe v. Wade established a framework for regulations around abortion; they may not be regulated during the first trimester, but states may impose rules in the second semester that are related to health. “And then in the third trimester, once the fetus reaches viability, the state may regulate abortions or even prohibit them entirely, so long as there are exceptions for medical emergencies,” she said.

The Supreme Court ruling in the 1992 case of Planned Parenthood v. Casey did away with the trimester framework, Dr. Thompson said, and declared that abortion regulations could not place an “undue burden” on women.

This change allowed laws that “are purposely designed to trap providers and clinics and to restrict their ability to provide abortions, not due to health concerns but really just to prevent pregnant people from accessing care,” she said.

In 2018, Mississippi passed a law – which never went into effect and is now challenged before the Supreme Court – that makes most abortions illegal after 15 weeks. And in September 2021, a Texas law went into effect that outlaws abortions after a fetal heartbeat is detected.

What happens if Roe is overturned and laws that ban or severely limit abortion go into effect in states across the country? In Nashville, Dr. Thompson said, patients will have to travel to Illinois – more than 300 miles away – to reach the nearest abortion clinic.

“When I think about my own clinical practice over the last year, [if the law were in place] I would not have been able to offer an abortion to a developmentally delayed, nonverbal patient who was raped by her brother,” she said. “I would not have been able to offer an abortion to the service person who was sexually assaulted by a coworker in the field. I would not have been able to offer an abortion to a person with a pregnancy complicated by a hypoplastic left heart, congenital diaphragmatic hernias with the stomach in the thorax, an unformed lumbar spine, and other anomalies.”

Bhavik Kumar, MD, a family medicine physician and medical director for primary and trans care at Planned Parenthood Gulf Coast in Houston, said the effects of the new law in Texas are already apparent. As he told ABC News last fall, he used to perform 20-30 abortions per day, but the number dwindled immediately the day the law went into effect.

At the ACOG presentation, Dr. Kumar highlighted a March 2022 research brief that reported that abortions in Texas fell by half in the month after the law was implemented compared with the previous year. And the average number of abortions performed on Texans who left the state grew by more than 10-fold from the period of September-December 2019 (514) to September-December 2021 (5,574).

Once the law went into effect, Dr. Kumar said, “we began to see longer waiting times at clinics in nearby states, wait times that started out as short as a day go to an average of 2-3 weeks to get an initial appointment. And some of these states also have mandatory delays of up to 72 hours.”

Dr. Kumar added that he’s “heard from emergency-room physicians and nurses who call and ask me what they can and cannot say when providing care for pregnant people in Texas and how they should be counseling their patients who may need emergency or urgent care after returning to Texas.”

Dr. Brandi cautioned colleagues that even ob.gyns. who don’t perform abortions will still be affected by the overturning of Roe. In some states, they’ll have to understand the rules about treating women with early ruptured membranes when cardiac motion is detected or with atopic pregnancies with cardiac activity at risk of potential tubal rupture.

The speakers urged colleagues to take action at the ballot box and their own clinics to protect patients. “While the recent leak is a truly scary moment for our country and for our practices, I’m hopeful that it will help galvanize our communities,” Dr. Brandi said. Regardless of where you live, regardless of where you practice, this ruling impacts all ob.gyns., everyone in this room. Each of us needs to go home after this conference and figure out what you are going to do to make sure that our patients can still get the care that they need.”

SAN DIEGO – The end of the legal standards set by Roe v. Wade will likely lead to bans in as many as 26 states and send a flood of abortion seekers to the remaining states that still allow the procedure, an obstetrician-gynecologist warned colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“The blue states neighboring those states will likely see an outpouring of patients among those who can travel,” Kristyn Brandi, MD, of New Jersey Medical School, Newark, said in a presentation about legal threats to abortion rights. “These will likely flood the health care systems and delay care for everyone. Make no mistake: Virtually all ob.gyns. across the country have the potential to be impacted.”

Indeed, research suggests that thousands more Texans than usual are heading out of state for abortions each month in the wake of a new, strict antiabortion law there.

Only three sessions at the 3-day ACOG meeting directly addressed abortion. But the topic was clearly on the minds of attendees in the wake of the release of a leaked draft of a Supreme Court ruling that would eliminate federal protection for abortion rights.

The 57,000-member ACOG organization firmly supports abortion rights and declares on its website that “Abortion Is Healthcare.”

In a workshop on challenges to abortion, ACOG chief of staff Dorothea Calvano Lindquist said “we remain your steadfast partner in advocacy and guidance on all levels.”

Ivana S. Thompson, MD, an ob.gyn. at Vanderbilt University, Nashville, Tenn., explained in a presentation that Roe v. Wade established a framework for regulations around abortion; they may not be regulated during the first trimester, but states may impose rules in the second semester that are related to health. “And then in the third trimester, once the fetus reaches viability, the state may regulate abortions or even prohibit them entirely, so long as there are exceptions for medical emergencies,” she said.

The Supreme Court ruling in the 1992 case of Planned Parenthood v. Casey did away with the trimester framework, Dr. Thompson said, and declared that abortion regulations could not place an “undue burden” on women.

This change allowed laws that “are purposely designed to trap providers and clinics and to restrict their ability to provide abortions, not due to health concerns but really just to prevent pregnant people from accessing care,” she said.

In 2018, Mississippi passed a law – which never went into effect and is now challenged before the Supreme Court – that makes most abortions illegal after 15 weeks. And in September 2021, a Texas law went into effect that outlaws abortions after a fetal heartbeat is detected.

What happens if Roe is overturned and laws that ban or severely limit abortion go into effect in states across the country? In Nashville, Dr. Thompson said, patients will have to travel to Illinois – more than 300 miles away – to reach the nearest abortion clinic.

“When I think about my own clinical practice over the last year, [if the law were in place] I would not have been able to offer an abortion to a developmentally delayed, nonverbal patient who was raped by her brother,” she said. “I would not have been able to offer an abortion to the service person who was sexually assaulted by a coworker in the field. I would not have been able to offer an abortion to a person with a pregnancy complicated by a hypoplastic left heart, congenital diaphragmatic hernias with the stomach in the thorax, an unformed lumbar spine, and other anomalies.”

Bhavik Kumar, MD, a family medicine physician and medical director for primary and trans care at Planned Parenthood Gulf Coast in Houston, said the effects of the new law in Texas are already apparent. As he told ABC News last fall, he used to perform 20-30 abortions per day, but the number dwindled immediately the day the law went into effect.

At the ACOG presentation, Dr. Kumar highlighted a March 2022 research brief that reported that abortions in Texas fell by half in the month after the law was implemented compared with the previous year. And the average number of abortions performed on Texans who left the state grew by more than 10-fold from the period of September-December 2019 (514) to September-December 2021 (5,574).

Once the law went into effect, Dr. Kumar said, “we began to see longer waiting times at clinics in nearby states, wait times that started out as short as a day go to an average of 2-3 weeks to get an initial appointment. And some of these states also have mandatory delays of up to 72 hours.”

Dr. Kumar added that he’s “heard from emergency-room physicians and nurses who call and ask me what they can and cannot say when providing care for pregnant people in Texas and how they should be counseling their patients who may need emergency or urgent care after returning to Texas.”

Dr. Brandi cautioned colleagues that even ob.gyns. who don’t perform abortions will still be affected by the overturning of Roe. In some states, they’ll have to understand the rules about treating women with early ruptured membranes when cardiac motion is detected or with atopic pregnancies with cardiac activity at risk of potential tubal rupture.

The speakers urged colleagues to take action at the ballot box and their own clinics to protect patients. “While the recent leak is a truly scary moment for our country and for our practices, I’m hopeful that it will help galvanize our communities,” Dr. Brandi said. Regardless of where you live, regardless of where you practice, this ruling impacts all ob.gyns., everyone in this room. Each of us needs to go home after this conference and figure out what you are going to do to make sure that our patients can still get the care that they need.”

SAN DIEGO – The end of the legal standards set by Roe v. Wade will likely lead to bans in as many as 26 states and send a flood of abortion seekers to the remaining states that still allow the procedure, an obstetrician-gynecologist warned colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“The blue states neighboring those states will likely see an outpouring of patients among those who can travel,” Kristyn Brandi, MD, of New Jersey Medical School, Newark, said in a presentation about legal threats to abortion rights. “These will likely flood the health care systems and delay care for everyone. Make no mistake: Virtually all ob.gyns. across the country have the potential to be impacted.”

Indeed, research suggests that thousands more Texans than usual are heading out of state for abortions each month in the wake of a new, strict antiabortion law there.

Only three sessions at the 3-day ACOG meeting directly addressed abortion. But the topic was clearly on the minds of attendees in the wake of the release of a leaked draft of a Supreme Court ruling that would eliminate federal protection for abortion rights.

The 57,000-member ACOG organization firmly supports abortion rights and declares on its website that “Abortion Is Healthcare.”

In a workshop on challenges to abortion, ACOG chief of staff Dorothea Calvano Lindquist said “we remain your steadfast partner in advocacy and guidance on all levels.”

Ivana S. Thompson, MD, an ob.gyn. at Vanderbilt University, Nashville, Tenn., explained in a presentation that Roe v. Wade established a framework for regulations around abortion; they may not be regulated during the first trimester, but states may impose rules in the second semester that are related to health. “And then in the third trimester, once the fetus reaches viability, the state may regulate abortions or even prohibit them entirely, so long as there are exceptions for medical emergencies,” she said.

The Supreme Court ruling in the 1992 case of Planned Parenthood v. Casey did away with the trimester framework, Dr. Thompson said, and declared that abortion regulations could not place an “undue burden” on women.

This change allowed laws that “are purposely designed to trap providers and clinics and to restrict their ability to provide abortions, not due to health concerns but really just to prevent pregnant people from accessing care,” she said.

In 2018, Mississippi passed a law – which never went into effect and is now challenged before the Supreme Court – that makes most abortions illegal after 15 weeks. And in September 2021, a Texas law went into effect that outlaws abortions after a fetal heartbeat is detected.

What happens if Roe is overturned and laws that ban or severely limit abortion go into effect in states across the country? In Nashville, Dr. Thompson said, patients will have to travel to Illinois – more than 300 miles away – to reach the nearest abortion clinic.

“When I think about my own clinical practice over the last year, [if the law were in place] I would not have been able to offer an abortion to a developmentally delayed, nonverbal patient who was raped by her brother,” she said. “I would not have been able to offer an abortion to the service person who was sexually assaulted by a coworker in the field. I would not have been able to offer an abortion to a person with a pregnancy complicated by a hypoplastic left heart, congenital diaphragmatic hernias with the stomach in the thorax, an unformed lumbar spine, and other anomalies.”

Bhavik Kumar, MD, a family medicine physician and medical director for primary and trans care at Planned Parenthood Gulf Coast in Houston, said the effects of the new law in Texas are already apparent. As he told ABC News last fall, he used to perform 20-30 abortions per day, but the number dwindled immediately the day the law went into effect.

At the ACOG presentation, Dr. Kumar highlighted a March 2022 research brief that reported that abortions in Texas fell by half in the month after the law was implemented compared with the previous year. And the average number of abortions performed on Texans who left the state grew by more than 10-fold from the period of September-December 2019 (514) to September-December 2021 (5,574).

Once the law went into effect, Dr. Kumar said, “we began to see longer waiting times at clinics in nearby states, wait times that started out as short as a day go to an average of 2-3 weeks to get an initial appointment. And some of these states also have mandatory delays of up to 72 hours.”

Dr. Kumar added that he’s “heard from emergency-room physicians and nurses who call and ask me what they can and cannot say when providing care for pregnant people in Texas and how they should be counseling their patients who may need emergency or urgent care after returning to Texas.”

Dr. Brandi cautioned colleagues that even ob.gyns. who don’t perform abortions will still be affected by the overturning of Roe. In some states, they’ll have to understand the rules about treating women with early ruptured membranes when cardiac motion is detected or with atopic pregnancies with cardiac activity at risk of potential tubal rupture.

The speakers urged colleagues to take action at the ballot box and their own clinics to protect patients. “While the recent leak is a truly scary moment for our country and for our practices, I’m hopeful that it will help galvanize our communities,” Dr. Brandi said. Regardless of where you live, regardless of where you practice, this ruling impacts all ob.gyns., everyone in this room. Each of us needs to go home after this conference and figure out what you are going to do to make sure that our patients can still get the care that they need.”

The percentage of low-income pregnant mothers who received influenza and Tdap vaccinations fell sharply during the COVID-19 pandemic, especially in Black and Hispanic patients, a new study finds.

The percentage of patients who received the influenza vaccines at two Medicaid clinics in Houston dropped from 78% before the pandemic to 61% during it (adjusted odds ratio, 0.38; 95% CI, 0.26-0.53; P < .01), researchers reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The percentage receiving the Tdap vaccine dipped from 85% to 76% (aOR, 0.56; 95% CI, 0.40-0.79; P < .01).

New York–Presbyterian/Weill Cornell Medical Center pediatrician Sallie Permar, MD, PhD, who’s familiar with the study findings, called them “alarming” and said in an interview that they should be “a call to action for providers.”

“Continuing the status quo in our routine preventative health care and clinic operations means that we are losing ground in reduction and elimination of vaccine-preventable diseases,” Dr. Permar said in an interview.

According to corresponding author Bani Ratan, MD, an ob.gyn. with the Baylor College of Medicine, Houston, there’s been little if any previous research into routine, non-COVID vaccination in pregnant women during the pandemic.

For the study, researchers retrospectively analyzed the records of 939 pregnant women who entered prenatal care before 20 weeks (462 from May–November 2019, and 477 from May–November 2020) and delivered at full term.

Among ethnic groups, non-Hispanic Blacks saw the largest decline in influenza vaccines. Among them, the percentage who got them fell from 64% (73/114) to 35% (35/101; aOR, 0.30; 95% CI, 0.17-0.52; P < .01). Only Hispanics had a statistically significant decline in Tdap vaccination (OR, 0.52, 95% CI, 0.34-0.80; P < .01, percentages not provided).

Another study presented at ACOG examined vaccination rates during the pandemic and found that Tdap vaccination rates dipped among pregnant women in a Philadelphia-area health care system.

Possible causes for the decline in routine vaccination include hesitancy linked to the COVID-19 vaccines and fewer office visits because of telemedicine, said Dr. Batan in an interview.

Dr. Permar blamed the role of vaccine misinformation during the pandemic and the mistrust caused by the exclusion of pregnant women from early vaccine trials. She added that “challenges in health care staffing and issues of health care provider burnout that worsened during the pandemic likely contributed to a fraying of the focus on preventive health maintenance simply due to bandwidth of health professionals.”

In a separate study presented at ACOG, researchers at the State University of New York, Syracuse, reported on a survey of 157 pregnant women of whom just 38.2% were vaccinated against COVID-19. Among the unvaccinated, who were more likely to have less education, 66% reported that lack of data about vaccination was their primary concern.

No funding or disclosures are reported by study authors. Dr. Permar reported consulting for Merck, Moderna, GlaxoSmithKline, Pfizer, Dynavax, and Hookipa on cytomegalovirus vaccine programs.

*This story was updated on 5/11/2022.

The percentage of low-income pregnant mothers who received influenza and Tdap vaccinations fell sharply during the COVID-19 pandemic, especially in Black and Hispanic patients, a new study finds.

The percentage of patients who received the influenza vaccines at two Medicaid clinics in Houston dropped from 78% before the pandemic to 61% during it (adjusted odds ratio, 0.38; 95% CI, 0.26-0.53; P < .01), researchers reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The percentage receiving the Tdap vaccine dipped from 85% to 76% (aOR, 0.56; 95% CI, 0.40-0.79; P < .01).

New York–Presbyterian/Weill Cornell Medical Center pediatrician Sallie Permar, MD, PhD, who’s familiar with the study findings, called them “alarming” and said in an interview that they should be “a call to action for providers.”

“Continuing the status quo in our routine preventative health care and clinic operations means that we are losing ground in reduction and elimination of vaccine-preventable diseases,” Dr. Permar said in an interview.

According to corresponding author Bani Ratan, MD, an ob.gyn. with the Baylor College of Medicine, Houston, there’s been little if any previous research into routine, non-COVID vaccination in pregnant women during the pandemic.

For the study, researchers retrospectively analyzed the records of 939 pregnant women who entered prenatal care before 20 weeks (462 from May–November 2019, and 477 from May–November 2020) and delivered at full term.

Among ethnic groups, non-Hispanic Blacks saw the largest decline in influenza vaccines. Among them, the percentage who got them fell from 64% (73/114) to 35% (35/101; aOR, 0.30; 95% CI, 0.17-0.52; P < .01). Only Hispanics had a statistically significant decline in Tdap vaccination (OR, 0.52, 95% CI, 0.34-0.80; P < .01, percentages not provided).

Another study presented at ACOG examined vaccination rates during the pandemic and found that Tdap vaccination rates dipped among pregnant women in a Philadelphia-area health care system.

Possible causes for the decline in routine vaccination include hesitancy linked to the COVID-19 vaccines and fewer office visits because of telemedicine, said Dr. Batan in an interview.

Dr. Permar blamed the role of vaccine misinformation during the pandemic and the mistrust caused by the exclusion of pregnant women from early vaccine trials. She added that “challenges in health care staffing and issues of health care provider burnout that worsened during the pandemic likely contributed to a fraying of the focus on preventive health maintenance simply due to bandwidth of health professionals.”

In a separate study presented at ACOG, researchers at the State University of New York, Syracuse, reported on a survey of 157 pregnant women of whom just 38.2% were vaccinated against COVID-19. Among the unvaccinated, who were more likely to have less education, 66% reported that lack of data about vaccination was their primary concern.

No funding or disclosures are reported by study authors. Dr. Permar reported consulting for Merck, Moderna, GlaxoSmithKline, Pfizer, Dynavax, and Hookipa on cytomegalovirus vaccine programs.

*This story was updated on 5/11/2022.

The percentage of low-income pregnant mothers who received influenza and Tdap vaccinations fell sharply during the COVID-19 pandemic, especially in Black and Hispanic patients, a new study finds.

The percentage of patients who received the influenza vaccines at two Medicaid clinics in Houston dropped from 78% before the pandemic to 61% during it (adjusted odds ratio, 0.38; 95% CI, 0.26-0.53; P < .01), researchers reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The percentage receiving the Tdap vaccine dipped from 85% to 76% (aOR, 0.56; 95% CI, 0.40-0.79; P < .01).

New York–Presbyterian/Weill Cornell Medical Center pediatrician Sallie Permar, MD, PhD, who’s familiar with the study findings, called them “alarming” and said in an interview that they should be “a call to action for providers.”

“Continuing the status quo in our routine preventative health care and clinic operations means that we are losing ground in reduction and elimination of vaccine-preventable diseases,” Dr. Permar said in an interview.

According to corresponding author Bani Ratan, MD, an ob.gyn. with the Baylor College of Medicine, Houston, there’s been little if any previous research into routine, non-COVID vaccination in pregnant women during the pandemic.

For the study, researchers retrospectively analyzed the records of 939 pregnant women who entered prenatal care before 20 weeks (462 from May–November 2019, and 477 from May–November 2020) and delivered at full term.

Among ethnic groups, non-Hispanic Blacks saw the largest decline in influenza vaccines. Among them, the percentage who got them fell from 64% (73/114) to 35% (35/101; aOR, 0.30; 95% CI, 0.17-0.52; P < .01). Only Hispanics had a statistically significant decline in Tdap vaccination (OR, 0.52, 95% CI, 0.34-0.80; P < .01, percentages not provided).

Another study presented at ACOG examined vaccination rates during the pandemic and found that Tdap vaccination rates dipped among pregnant women in a Philadelphia-area health care system.

Possible causes for the decline in routine vaccination include hesitancy linked to the COVID-19 vaccines and fewer office visits because of telemedicine, said Dr. Batan in an interview.

Dr. Permar blamed the role of vaccine misinformation during the pandemic and the mistrust caused by the exclusion of pregnant women from early vaccine trials. She added that “challenges in health care staffing and issues of health care provider burnout that worsened during the pandemic likely contributed to a fraying of the focus on preventive health maintenance simply due to bandwidth of health professionals.”

In a separate study presented at ACOG, researchers at the State University of New York, Syracuse, reported on a survey of 157 pregnant women of whom just 38.2% were vaccinated against COVID-19. Among the unvaccinated, who were more likely to have less education, 66% reported that lack of data about vaccination was their primary concern.

No funding or disclosures are reported by study authors. Dr. Permar reported consulting for Merck, Moderna, GlaxoSmithKline, Pfizer, Dynavax, and Hookipa on cytomegalovirus vaccine programs.

*This story was updated on 5/11/2022.

The wide majority of at-home sexually transmitted infection testing kits in the United States appear to be limited to use by adults, a new study finds, and many have limitations that make them less than ideal for young people to use.

While at-home kits do allow more access to STI testing, “we need to create programs that are specific for youth because they have extra needs,” said lead author Saumya Sao, a research assistant at the department of gynecology & obstetrics at Johns Hopkins University, Baltimore, in an interview. “The only platform that did meet our needs was the program that we developed specifically.”

The findings were released ahead of the study’s scheduled presentation at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (Session A117).

According to Ms. Sao, companies began to offer more at-home testing kits during the pandemic as in-person STI clinics shut down. Still, “the fact that we only found 13 self-collect mail-in STI programs shows you that this is pretty new,” she said. “There are not too many companies that do it. We found a lot more platforms that allow users to place orders for testing online, but you’re still required to go into a lab and actually do the testing.”

The researchers gathered information about 13 programs, including the one that they developed at Johns Hopkins known as Violet. Of those, seven limited testing to adults aged 18 and up, and one didn’t list an age requirement. The rest had some age requirements (such as 14 and up) or no age requirements.

The lack of full access for teens is problematic, Ms. Sao said. According to the study, “access to testing among young people is especially important because youth (ages 13-24) bear a disproportionate burden of sexually transmitted infection, accounting for 50% of cases but only 25% of the sexually active population.”

Research has suggested that young people are often wary of visiting STI clinics because they fear stigma from medical professionals or worry about being seen there, Ms. Sao said.

Tests are free in only three of the programs analyzed in the new study. Among the other programs, tests for Chlamydia trachomatis and Neisseria gonorrhoeae cost $45-$179; only two accepted insurance. “These out-of-pocket costs are really high in regard to what a young person might be able to afford for testing, especially if they would need to do repeat testing between partners, or 3 months after testing positive,” Ms. Sao said.

Most of the programs will link users to medical professionals if they test positive. This is a key feature, Ms. Sao said, in order to make sure young people have support.

As for location, most of the programs – including all those that offer free testing – are limited to certain states. Planned Parenthood, for example, only offers at-home STI testing in Maine, New Hampshire, and Vermont. The program charges patients on a sliding scale, accepts insurance, and is available for ages 14 and up. It connects users who test positive to physicians.

Another free program, TakeMeHome, is restricted to 16 states. It includes an HIV panel for ages 17+ (although it doesn’t have vaginal swab testing). It recommends that patients who are positive consult a doctor.

The researchers also found that some, but not all, of the programs send testing material in discreet packaging. This is important to young people because they may not want their parents to know that they’re getting tested.

Some of the testing programs analyzed don’t make it clear on their web sites whether their packaging is discreet, Ms. Sao said.

At Johns Hopkins, Ms. Sao has helped develop the Violet Project, which is designed to meet the needs of young people and offers free STI testing to residents of Maryland of any age for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Mailing packages are discreet, and physicians reach out to those who test positive. Fees are covered.

“We don’t have money yet to expand beyond Maryland, but we’re hopeful,” she said.

In an interview, Loma Linda (Calif.) University Health maternal-fetal medicine specialist Sarah Smithson, DO, MS, praised the study and said she supports optimizing at-home testing for young people. It may be useful for youths who first get tested in a clinic but then need follow-up testing or testing of their partners, she said.

Dr. Smithson added that transportation is often a challenge for young people. At her pregnancy clinic in California’s Inland Empire, she said, some patients live in remote areas and make virtual doctor visits because of the distance. STI testing is crucial for pregnant women, she said, “and this could be a game changer for them.”

The wide majority of at-home sexually transmitted infection testing kits in the United States appear to be limited to use by adults, a new study finds, and many have limitations that make them less than ideal for young people to use.

While at-home kits do allow more access to STI testing, “we need to create programs that are specific for youth because they have extra needs,” said lead author Saumya Sao, a research assistant at the department of gynecology & obstetrics at Johns Hopkins University, Baltimore, in an interview. “The only platform that did meet our needs was the program that we developed specifically.”

The findings were released ahead of the study’s scheduled presentation at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (Session A117).

According to Ms. Sao, companies began to offer more at-home testing kits during the pandemic as in-person STI clinics shut down. Still, “the fact that we only found 13 self-collect mail-in STI programs shows you that this is pretty new,” she said. “There are not too many companies that do it. We found a lot more platforms that allow users to place orders for testing online, but you’re still required to go into a lab and actually do the testing.”

The researchers gathered information about 13 programs, including the one that they developed at Johns Hopkins known as Violet. Of those, seven limited testing to adults aged 18 and up, and one didn’t list an age requirement. The rest had some age requirements (such as 14 and up) or no age requirements.

The lack of full access for teens is problematic, Ms. Sao said. According to the study, “access to testing among young people is especially important because youth (ages 13-24) bear a disproportionate burden of sexually transmitted infection, accounting for 50% of cases but only 25% of the sexually active population.”

Research has suggested that young people are often wary of visiting STI clinics because they fear stigma from medical professionals or worry about being seen there, Ms. Sao said.

Tests are free in only three of the programs analyzed in the new study. Among the other programs, tests for Chlamydia trachomatis and Neisseria gonorrhoeae cost $45-$179; only two accepted insurance. “These out-of-pocket costs are really high in regard to what a young person might be able to afford for testing, especially if they would need to do repeat testing between partners, or 3 months after testing positive,” Ms. Sao said.

Most of the programs will link users to medical professionals if they test positive. This is a key feature, Ms. Sao said, in order to make sure young people have support.

As for location, most of the programs – including all those that offer free testing – are limited to certain states. Planned Parenthood, for example, only offers at-home STI testing in Maine, New Hampshire, and Vermont. The program charges patients on a sliding scale, accepts insurance, and is available for ages 14 and up. It connects users who test positive to physicians.

Another free program, TakeMeHome, is restricted to 16 states. It includes an HIV panel for ages 17+ (although it doesn’t have vaginal swab testing). It recommends that patients who are positive consult a doctor.

The researchers also found that some, but not all, of the programs send testing material in discreet packaging. This is important to young people because they may not want their parents to know that they’re getting tested.

Some of the testing programs analyzed don’t make it clear on their web sites whether their packaging is discreet, Ms. Sao said.

At Johns Hopkins, Ms. Sao has helped develop the Violet Project, which is designed to meet the needs of young people and offers free STI testing to residents of Maryland of any age for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Mailing packages are discreet, and physicians reach out to those who test positive. Fees are covered.

“We don’t have money yet to expand beyond Maryland, but we’re hopeful,” she said.

In an interview, Loma Linda (Calif.) University Health maternal-fetal medicine specialist Sarah Smithson, DO, MS, praised the study and said she supports optimizing at-home testing for young people. It may be useful for youths who first get tested in a clinic but then need follow-up testing or testing of their partners, she said.

Dr. Smithson added that transportation is often a challenge for young people. At her pregnancy clinic in California’s Inland Empire, she said, some patients live in remote areas and make virtual doctor visits because of the distance. STI testing is crucial for pregnant women, she said, “and this could be a game changer for them.”

The wide majority of at-home sexually transmitted infection testing kits in the United States appear to be limited to use by adults, a new study finds, and many have limitations that make them less than ideal for young people to use.

While at-home kits do allow more access to STI testing, “we need to create programs that are specific for youth because they have extra needs,” said lead author Saumya Sao, a research assistant at the department of gynecology & obstetrics at Johns Hopkins University, Baltimore, in an interview. “The only platform that did meet our needs was the program that we developed specifically.”

The findings were released ahead of the study’s scheduled presentation at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (Session A117).

According to Ms. Sao, companies began to offer more at-home testing kits during the pandemic as in-person STI clinics shut down. Still, “the fact that we only found 13 self-collect mail-in STI programs shows you that this is pretty new,” she said. “There are not too many companies that do it. We found a lot more platforms that allow users to place orders for testing online, but you’re still required to go into a lab and actually do the testing.”

The researchers gathered information about 13 programs, including the one that they developed at Johns Hopkins known as Violet. Of those, seven limited testing to adults aged 18 and up, and one didn’t list an age requirement. The rest had some age requirements (such as 14 and up) or no age requirements.

The lack of full access for teens is problematic, Ms. Sao said. According to the study, “access to testing among young people is especially important because youth (ages 13-24) bear a disproportionate burden of sexually transmitted infection, accounting for 50% of cases but only 25% of the sexually active population.”

Research has suggested that young people are often wary of visiting STI clinics because they fear stigma from medical professionals or worry about being seen there, Ms. Sao said.

Tests are free in only three of the programs analyzed in the new study. Among the other programs, tests for Chlamydia trachomatis and Neisseria gonorrhoeae cost $45-$179; only two accepted insurance. “These out-of-pocket costs are really high in regard to what a young person might be able to afford for testing, especially if they would need to do repeat testing between partners, or 3 months after testing positive,” Ms. Sao said.

Most of the programs will link users to medical professionals if they test positive. This is a key feature, Ms. Sao said, in order to make sure young people have support.

As for location, most of the programs – including all those that offer free testing – are limited to certain states. Planned Parenthood, for example, only offers at-home STI testing in Maine, New Hampshire, and Vermont. The program charges patients on a sliding scale, accepts insurance, and is available for ages 14 and up. It connects users who test positive to physicians.

Another free program, TakeMeHome, is restricted to 16 states. It includes an HIV panel for ages 17+ (although it doesn’t have vaginal swab testing). It recommends that patients who are positive consult a doctor.

The researchers also found that some, but not all, of the programs send testing material in discreet packaging. This is important to young people because they may not want their parents to know that they’re getting tested.

Some of the testing programs analyzed don’t make it clear on their web sites whether their packaging is discreet, Ms. Sao said.

At Johns Hopkins, Ms. Sao has helped develop the Violet Project, which is designed to meet the needs of young people and offers free STI testing to residents of Maryland of any age for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Mailing packages are discreet, and physicians reach out to those who test positive. Fees are covered.

“We don’t have money yet to expand beyond Maryland, but we’re hopeful,” she said.

In an interview, Loma Linda (Calif.) University Health maternal-fetal medicine specialist Sarah Smithson, DO, MS, praised the study and said she supports optimizing at-home testing for young people. It may be useful for youths who first get tested in a clinic but then need follow-up testing or testing of their partners, she said.

Dr. Smithson added that transportation is often a challenge for young people. At her pregnancy clinic in California’s Inland Empire, she said, some patients live in remote areas and make virtual doctor visits because of the distance. STI testing is crucial for pregnant women, she said, “and this could be a game changer for them.”

A small new study of women suggests that adopting a low-fat vegan diet and then eliminating remaining trigger foods may dramatically reduce symptoms of rheumatoid arthritis (RA) within months. After 16 weeks, the mean Disease Activity Score in 28 joints (DAS28) decreased from 4.5 to 2.5 (P < .001), and the mean number of swollen joints dipped from 7.0 to 3.3 (P = .03).

The study was published in the American Journal of Lifestyle Medicine. It’s not clear whether the vegan diet or the restriction of trigger foods – or both or neither – was helpful. Significant weight loss in the diet group could have played a role in reducing symptoms.

galitskaya / iStock / Getty Images

Still, the dietary strategy is “a life-changing experience for people,” lead author Neal D. Barnard, MD, an internal medicine specialist and adjunct professor of medicine at George Washington University, Washington, D.C, and president of the Physicians Committee for Responsible Medicine, said in an interview. “Doctors should know about it, and they should try it themselves.”

The researchers launched the study to determine the feasibility of a “practical and easy-to-prescribe diet” without caloric limits, Dr. Barnard said. “People have done a variety of studies where they’ve looked at diet changes, often with fasting, and the quality has been variable.”

There’s no consensus in the medical literature on which dietary approach is best for patients with RA. A 2021 systematic review by Philippa and colleagues found positive results for the Mediterranean diet, high doses of omega-3 fatty acids, vitamin D supplementation, and sodium restriction. Fasting had significant but temporary effects, and the reviewers noted “outcomes from vegetarian, elimination, peptide, or elemental diets suggested that responses are very individualized.”

For the new randomized, crossover study, researchers assigned 44 women to one of two diet phases. After 16 weeks, they had a 4-week washout period, then began the other 16-week phase. A total of 32 patients completed the study, and they had a mean age of 57 years. Overall, 66% were White, 16% were Black, and 79% held a college degree or graduate degree.

In the 16-week intervention phase, participants went on a low-fat vegan diet. After 4 weeks, they eliminated common RA trigger foods such as grains with gluten, nuts, citrus fruits, and chocolate. After week 7, the subjects added back the trigger foods one by one, keeping them in their diet if they didn’t seem to cause pain.

In the 16-week placebo phase, the women took a supplement that they were told contained omega-3 oils and vitamin E. However, the amounts of omega-3 and vitamin E were very low and had no apparent effect.

Participants in the diet phase attended weekly 1-hour dietary support-group sessions. Thirty-two women completed the full study.

Average DAS28 scores fell in the diet phase, compared with the supplement phase (treatment effect, 1.8 [95% confidence interval [CI], 3.2 to 0.4]; P = .01), as did swollen joints (treatment effect, –4.2 [95% CI, –8.3 to –0.1], P = .047).

While the researchers reported dips in the DAS28 score and swollen joints, “the reductions in the number of painful and tender joints did not reach statistical significance (treatment effects, –4.1 [95% CI, –8.7 to +0.5]; P = .08; and –1.8 [95% CI, –5.5 to +1.9]; P = .41, respectively).”

Mean body weight fell by 6.5 kg among those in the diet group, while those in the placebo group gained 0.8 kg (treatment effect, –7.3 kg [95% CI, –9.4 to –5.1]; P < .001).

The researchers noted “the presumed mechanisms by which diets such [as this intervention strategy] reduce joint symptoms relate to the removal of inflammatory elements of an omnivorous diet, the presence of anti-inflammatory constituents in a plant-based diet, and diet-induced reductions in gut permeability that may, in turn, reduce the passage of antigens into circulation.”

Patients tolerate the diet well, Dr. Barnard said. “It’s practical for day-to-day life, and you don’t have to check into a fasting hospital.”

Elliott O’Donovan Photography

The message for physicians, he said, is to encourage patients to try changing their eating patterns before turning to medication. “It’s a good idea for anyone to have a chance to try a diet change,” he said. “You’ll know within a matter of weeks whether it will work.”

Vegan diets are also cheaper than diets with meat and dairy, he added.

The study has various limitations. It began with 44 participants, but 12 failed to complete it for various reasons. Four participants who were assigned to the diet phase first refused to resume their regular diets during the next phase. It’s not clear if the lost weight is most responsible for the diet’s benefits, Harvard Medical School rheumatologist Daniel H. Solomon, MD, MPH, said in an interview. In his review of the study findings, Dr. Solomon said that another possibility is that certain aspects of the diet – and not the full diet – were responsible.

A small new study of women suggests that adopting a low-fat vegan diet and then eliminating remaining trigger foods may dramatically reduce symptoms of rheumatoid arthritis (RA) within months. After 16 weeks, the mean Disease Activity Score in 28 joints (DAS28) decreased from 4.5 to 2.5 (P < .001), and the mean number of swollen joints dipped from 7.0 to 3.3 (P = .03).

The study was published in the American Journal of Lifestyle Medicine. It’s not clear whether the vegan diet or the restriction of trigger foods – or both or neither – was helpful. Significant weight loss in the diet group could have played a role in reducing symptoms.

galitskaya / iStock / Getty Images

Still, the dietary strategy is “a life-changing experience for people,” lead author Neal D. Barnard, MD, an internal medicine specialist and adjunct professor of medicine at George Washington University, Washington, D.C, and president of the Physicians Committee for Responsible Medicine, said in an interview. “Doctors should know about it, and they should try it themselves.”

The researchers launched the study to determine the feasibility of a “practical and easy-to-prescribe diet” without caloric limits, Dr. Barnard said. “People have done a variety of studies where they’ve looked at diet changes, often with fasting, and the quality has been variable.”

There’s no consensus in the medical literature on which dietary approach is best for patients with RA. A 2021 systematic review by Philippa and colleagues found positive results for the Mediterranean diet, high doses of omega-3 fatty acids, vitamin D supplementation, and sodium restriction. Fasting had significant but temporary effects, and the reviewers noted “outcomes from vegetarian, elimination, peptide, or elemental diets suggested that responses are very individualized.”

For the new randomized, crossover study, researchers assigned 44 women to one of two diet phases. After 16 weeks, they had a 4-week washout period, then began the other 16-week phase. A total of 32 patients completed the study, and they had a mean age of 57 years. Overall, 66% were White, 16% were Black, and 79% held a college degree or graduate degree.

In the 16-week intervention phase, participants went on a low-fat vegan diet. After 4 weeks, they eliminated common RA trigger foods such as grains with gluten, nuts, citrus fruits, and chocolate. After week 7, the subjects added back the trigger foods one by one, keeping them in their diet if they didn’t seem to cause pain.

In the 16-week placebo phase, the women took a supplement that they were told contained omega-3 oils and vitamin E. However, the amounts of omega-3 and vitamin E were very low and had no apparent effect.

Participants in the diet phase attended weekly 1-hour dietary support-group sessions. Thirty-two women completed the full study.

Average DAS28 scores fell in the diet phase, compared with the supplement phase (treatment effect, 1.8 [95% confidence interval [CI], 3.2 to 0.4]; P = .01), as did swollen joints (treatment effect, –4.2 [95% CI, –8.3 to –0.1], P = .047).

While the researchers reported dips in the DAS28 score and swollen joints, “the reductions in the number of painful and tender joints did not reach statistical significance (treatment effects, –4.1 [95% CI, –8.7 to +0.5]; P = .08; and –1.8 [95% CI, –5.5 to +1.9]; P = .41, respectively).”

Mean body weight fell by 6.5 kg among those in the diet group, while those in the placebo group gained 0.8 kg (treatment effect, –7.3 kg [95% CI, –9.4 to –5.1]; P < .001).

The researchers noted “the presumed mechanisms by which diets such [as this intervention strategy] reduce joint symptoms relate to the removal of inflammatory elements of an omnivorous diet, the presence of anti-inflammatory constituents in a plant-based diet, and diet-induced reductions in gut permeability that may, in turn, reduce the passage of antigens into circulation.”

Patients tolerate the diet well, Dr. Barnard said. “It’s practical for day-to-day life, and you don’t have to check into a fasting hospital.”

Elliott O’Donovan Photography

The message for physicians, he said, is to encourage patients to try changing their eating patterns before turning to medication. “It’s a good idea for anyone to have a chance to try a diet change,” he said. “You’ll know within a matter of weeks whether it will work.”

Vegan diets are also cheaper than diets with meat and dairy, he added.

The study has various limitations. It began with 44 participants, but 12 failed to complete it for various reasons. Four participants who were assigned to the diet phase first refused to resume their regular diets during the next phase. It’s not clear if the lost weight is most responsible for the diet’s benefits, Harvard Medical School rheumatologist Daniel H. Solomon, MD, MPH, said in an interview. In his review of the study findings, Dr. Solomon said that another possibility is that certain aspects of the diet – and not the full diet – were responsible.

A small new study of women suggests that adopting a low-fat vegan diet and then eliminating remaining trigger foods may dramatically reduce symptoms of rheumatoid arthritis (RA) within months. After 16 weeks, the mean Disease Activity Score in 28 joints (DAS28) decreased from 4.5 to 2.5 (P < .001), and the mean number of swollen joints dipped from 7.0 to 3.3 (P = .03).

The study was published in the American Journal of Lifestyle Medicine. It’s not clear whether the vegan diet or the restriction of trigger foods – or both or neither – was helpful. Significant weight loss in the diet group could have played a role in reducing symptoms.

galitskaya / iStock / Getty Images

Still, the dietary strategy is “a life-changing experience for people,” lead author Neal D. Barnard, MD, an internal medicine specialist and adjunct professor of medicine at George Washington University, Washington, D.C, and president of the Physicians Committee for Responsible Medicine, said in an interview. “Doctors should know about it, and they should try it themselves.”

The researchers launched the study to determine the feasibility of a “practical and easy-to-prescribe diet” without caloric limits, Dr. Barnard said. “People have done a variety of studies where they’ve looked at diet changes, often with fasting, and the quality has been variable.”

There’s no consensus in the medical literature on which dietary approach is best for patients with RA. A 2021 systematic review by Philippa and colleagues found positive results for the Mediterranean diet, high doses of omega-3 fatty acids, vitamin D supplementation, and sodium restriction. Fasting had significant but temporary effects, and the reviewers noted “outcomes from vegetarian, elimination, peptide, or elemental diets suggested that responses are very individualized.”

For the new randomized, crossover study, researchers assigned 44 women to one of two diet phases. After 16 weeks, they had a 4-week washout period, then began the other 16-week phase. A total of 32 patients completed the study, and they had a mean age of 57 years. Overall, 66% were White, 16% were Black, and 79% held a college degree or graduate degree.

In the 16-week intervention phase, participants went on a low-fat vegan diet. After 4 weeks, they eliminated common RA trigger foods such as grains with gluten, nuts, citrus fruits, and chocolate. After week 7, the subjects added back the trigger foods one by one, keeping them in their diet if they didn’t seem to cause pain.

In the 16-week placebo phase, the women took a supplement that they were told contained omega-3 oils and vitamin E. However, the amounts of omega-3 and vitamin E were very low and had no apparent effect.

Participants in the diet phase attended weekly 1-hour dietary support-group sessions. Thirty-two women completed the full study.

Average DAS28 scores fell in the diet phase, compared with the supplement phase (treatment effect, 1.8 [95% confidence interval [CI], 3.2 to 0.4]; P = .01), as did swollen joints (treatment effect, –4.2 [95% CI, –8.3 to –0.1], P = .047).

While the researchers reported dips in the DAS28 score and swollen joints, “the reductions in the number of painful and tender joints did not reach statistical significance (treatment effects, –4.1 [95% CI, –8.7 to +0.5]; P = .08; and –1.8 [95% CI, –5.5 to +1.9]; P = .41, respectively).”

Mean body weight fell by 6.5 kg among those in the diet group, while those in the placebo group gained 0.8 kg (treatment effect, –7.3 kg [95% CI, –9.4 to –5.1]; P < .001).

The researchers noted “the presumed mechanisms by which diets such [as this intervention strategy] reduce joint symptoms relate to the removal of inflammatory elements of an omnivorous diet, the presence of anti-inflammatory constituents in a plant-based diet, and diet-induced reductions in gut permeability that may, in turn, reduce the passage of antigens into circulation.”

Patients tolerate the diet well, Dr. Barnard said. “It’s practical for day-to-day life, and you don’t have to check into a fasting hospital.”

Elliott O’Donovan Photography

The message for physicians, he said, is to encourage patients to try changing their eating patterns before turning to medication. “It’s a good idea for anyone to have a chance to try a diet change,” he said. “You’ll know within a matter of weeks whether it will work.”

Vegan diets are also cheaper than diets with meat and dairy, he added.

The study has various limitations. It began with 44 participants, but 12 failed to complete it for various reasons. Four participants who were assigned to the diet phase first refused to resume their regular diets during the next phase. It’s not clear if the lost weight is most responsible for the diet’s benefits, Harvard Medical School rheumatologist Daniel H. Solomon, MD, MPH, said in an interview. In his review of the study findings, Dr. Solomon said that another possibility is that certain aspects of the diet – and not the full diet – were responsible.

A pair of new studies offers more evidence for the value of vegetables and the risk of red meat on the cancer prevention front. Researchers report that high consumption of vegetables – especially lettuce, legumes, and cruciferous varieties – appears to lower the risk of liver cancer/liver disease. A separate team suggests that high consumption of red meat, organ meats, and processed meats boosts the risk of gastric cancer.

The findings of the latter study “reinforce the idea that avoidance of red meat and processed meat is probably good beyond [the prevention of] colorectal cancer,” said corresponding author and epidemiologist Paolo Boffetta, MD, MPH, of Stony Brook University Cancer Center, New York, in an interview. “The possible carcinogenic effect may extend beyond the colon.”

Both studies were released at the annual meeting of the American Association for Cancer Research.

For the red meat study, researchers examined statistics from the Golestan cohort study, which is prospectively tracking 50,045 people aged 40-75 from northeastern Iran. The study focuses on esophageal cancer due to the region’s high rate of the disease.

Red meat consumption is fairly rare in the region, where residents typically prefer chicken, said study lead author Giulia Collatuzzo, MD, a resident physician in occupational medicine at the University of Bologna, Italy, in an interview. On average, participants reported eating 18.4 grams daily of red meat and 72.1 grams daily of white meat.

The researchers tracked study participants for a median 12-year follow-up, during which 369 developed esophageal cancer and 368 developed gastric cancer. Red meat was only linked to more esophageal cancer in women (hazard ratio, 1.13, 95% confidence interval, 1.00-1.18, for each quintile increase in consumption).

Overall red meat consumption (including red meat, organ meat, and processed meat) was linked to higher rates of gastric cancer (HR, 1.08, 95% CI, 1.00-1.17) for each quartile increase in consumption, as was consumption of the red meat subtype alone (HR, 1.09, 95% CI, 1.00-1.18).

According to Dr. Collatuzzo, the findings suggest that those in the highest quartile of overall red meat consumption may have around a 25% increase in risk, compared with the lowest quartile.

Overall, she said, the study findings aren’t surprising. The lack of a connection between red meat consumption and esophageal cancer may be due to the fact that meat only temporarily transits through the esophagus, she said.

For the liver cancer/liver disease study, researchers examined the medical records of 470,653 subjects in the NIH-AARP Diet and Health Study. They were recruited in 1995-1996 when they were 50-71 years old. Over a median follow-up of 15.5 years, 899 developed liver cancer, and 934 died of chronic liver disease.

The median intakes of vegetables in quintile 5 (highest) and quintile 1 (lowest) were 3.7 cups daily and 1.0 cups daily, respectively, said study lead author Long-Gang Zhao, MS, a graduate student at Harvard University.

After adjusting for possible cofounders, those in the highest quintile of vegetable consumption were a third less likely to develop liver cancer, compared with the lowest quintile (HR, 0.66, 95% CI, 0.53-0.82, P < 0.01). Several types of vegetables appeared to be the strongest cancer fighters: cruciferous (broccoli, cauliflower), lettuce, legumes, and carrots. These kinds of vegetables were also linked to lower rates of chronic liver disease mortality (all P < 0.01), as was total vegetable intake for the top quintile versus the lowest quintile (HR, 0.60, 95% CI, 0.49-0.74, P = < 0.01).

“A one-cup increase (8 oz or 225 g) in vegetable intake was associated with about 20% decreased risk of liver cancer incidence and chronic liver mortality,” Zhao said.

There was no statistically significant link between fruit consumption and liver cancer or chronic liver disease mortality.

The findings provide more insight into diet and liver disease, Zhao said. “Chronic liver disease, which predisposes to liver cancer, is the tenth cause of death worldwide, causing two million deaths each year. It shares some etiological processes with liver cancer. Therefore, examining both chronic liver disease mortality and liver cancer incidence in our study may provide a more general picture for the prevention of liver diseases.”

As for limitations, both studies are based on self-reports about food consumption, which can be unreliable, and the subjects in the fruit/vegetable analysis were mainly of European origin.

The authors of both studies report no relevant disclosures. No funding is reported for either study.

A pair of new studies offers more evidence for the value of vegetables and the risk of red meat on the cancer prevention front. Researchers report that high consumption of vegetables – especially lettuce, legumes, and cruciferous varieties – appears to lower the risk of liver cancer/liver disease. A separate team suggests that high consumption of red meat, organ meats, and processed meats boosts the risk of gastric cancer.

The findings of the latter study “reinforce the idea that avoidance of red meat and processed meat is probably good beyond [the prevention of] colorectal cancer,” said corresponding author and epidemiologist Paolo Boffetta, MD, MPH, of Stony Brook University Cancer Center, New York, in an interview. “The possible carcinogenic effect may extend beyond the colon.”

Both studies were released at the annual meeting of the American Association for Cancer Research.

For the red meat study, researchers examined statistics from the Golestan cohort study, which is prospectively tracking 50,045 people aged 40-75 from northeastern Iran. The study focuses on esophageal cancer due to the region’s high rate of the disease.

Red meat consumption is fairly rare in the region, where residents typically prefer chicken, said study lead author Giulia Collatuzzo, MD, a resident physician in occupational medicine at the University of Bologna, Italy, in an interview. On average, participants reported eating 18.4 grams daily of red meat and 72.1 grams daily of white meat.

The researchers tracked study participants for a median 12-year follow-up, during which 369 developed esophageal cancer and 368 developed gastric cancer. Red meat was only linked to more esophageal cancer in women (hazard ratio, 1.13, 95% confidence interval, 1.00-1.18, for each quintile increase in consumption).

Overall red meat consumption (including red meat, organ meat, and processed meat) was linked to higher rates of gastric cancer (HR, 1.08, 95% CI, 1.00-1.17) for each quartile increase in consumption, as was consumption of the red meat subtype alone (HR, 1.09, 95% CI, 1.00-1.18).

According to Dr. Collatuzzo, the findings suggest that those in the highest quartile of overall red meat consumption may have around a 25% increase in risk, compared with the lowest quartile.

Overall, she said, the study findings aren’t surprising. The lack of a connection between red meat consumption and esophageal cancer may be due to the fact that meat only temporarily transits through the esophagus, she said.

For the liver cancer/liver disease study, researchers examined the medical records of 470,653 subjects in the NIH-AARP Diet and Health Study. They were recruited in 1995-1996 when they were 50-71 years old. Over a median follow-up of 15.5 years, 899 developed liver cancer, and 934 died of chronic liver disease.

The median intakes of vegetables in quintile 5 (highest) and quintile 1 (lowest) were 3.7 cups daily and 1.0 cups daily, respectively, said study lead author Long-Gang Zhao, MS, a graduate student at Harvard University.

After adjusting for possible cofounders, those in the highest quintile of vegetable consumption were a third less likely to develop liver cancer, compared with the lowest quintile (HR, 0.66, 95% CI, 0.53-0.82, P < 0.01). Several types of vegetables appeared to be the strongest cancer fighters: cruciferous (broccoli, cauliflower), lettuce, legumes, and carrots. These kinds of vegetables were also linked to lower rates of chronic liver disease mortality (all P < 0.01), as was total vegetable intake for the top quintile versus the lowest quintile (HR, 0.60, 95% CI, 0.49-0.74, P = < 0.01).

“A one-cup increase (8 oz or 225 g) in vegetable intake was associated with about 20% decreased risk of liver cancer incidence and chronic liver mortality,” Zhao said.

There was no statistically significant link between fruit consumption and liver cancer or chronic liver disease mortality.

The findings provide more insight into diet and liver disease, Zhao said. “Chronic liver disease, which predisposes to liver cancer, is the tenth cause of death worldwide, causing two million deaths each year. It shares some etiological processes with liver cancer. Therefore, examining both chronic liver disease mortality and liver cancer incidence in our study may provide a more general picture for the prevention of liver diseases.”

As for limitations, both studies are based on self-reports about food consumption, which can be unreliable, and the subjects in the fruit/vegetable analysis were mainly of European origin.

The authors of both studies report no relevant disclosures. No funding is reported for either study.

A pair of new studies offers more evidence for the value of vegetables and the risk of red meat on the cancer prevention front. Researchers report that high consumption of vegetables – especially lettuce, legumes, and cruciferous varieties – appears to lower the risk of liver cancer/liver disease. A separate team suggests that high consumption of red meat, organ meats, and processed meats boosts the risk of gastric cancer.

The findings of the latter study “reinforce the idea that avoidance of red meat and processed meat is probably good beyond [the prevention of] colorectal cancer,” said corresponding author and epidemiologist Paolo Boffetta, MD, MPH, of Stony Brook University Cancer Center, New York, in an interview. “The possible carcinogenic effect may extend beyond the colon.”

Both studies were released at the annual meeting of the American Association for Cancer Research.

For the red meat study, researchers examined statistics from the Golestan cohort study, which is prospectively tracking 50,045 people aged 40-75 from northeastern Iran. The study focuses on esophageal cancer due to the region’s high rate of the disease.

Red meat consumption is fairly rare in the region, where residents typically prefer chicken, said study lead author Giulia Collatuzzo, MD, a resident physician in occupational medicine at the University of Bologna, Italy, in an interview. On average, participants reported eating 18.4 grams daily of red meat and 72.1 grams daily of white meat.

The researchers tracked study participants for a median 12-year follow-up, during which 369 developed esophageal cancer and 368 developed gastric cancer. Red meat was only linked to more esophageal cancer in women (hazard ratio, 1.13, 95% confidence interval, 1.00-1.18, for each quintile increase in consumption).

Overall red meat consumption (including red meat, organ meat, and processed meat) was linked to higher rates of gastric cancer (HR, 1.08, 95% CI, 1.00-1.17) for each quartile increase in consumption, as was consumption of the red meat subtype alone (HR, 1.09, 95% CI, 1.00-1.18).

According to Dr. Collatuzzo, the findings suggest that those in the highest quartile of overall red meat consumption may have around a 25% increase in risk, compared with the lowest quartile.

Overall, she said, the study findings aren’t surprising. The lack of a connection between red meat consumption and esophageal cancer may be due to the fact that meat only temporarily transits through the esophagus, she said.

For the liver cancer/liver disease study, researchers examined the medical records of 470,653 subjects in the NIH-AARP Diet and Health Study. They were recruited in 1995-1996 when they were 50-71 years old. Over a median follow-up of 15.5 years, 899 developed liver cancer, and 934 died of chronic liver disease.

The median intakes of vegetables in quintile 5 (highest) and quintile 1 (lowest) were 3.7 cups daily and 1.0 cups daily, respectively, said study lead author Long-Gang Zhao, MS, a graduate student at Harvard University.

After adjusting for possible cofounders, those in the highest quintile of vegetable consumption were a third less likely to develop liver cancer, compared with the lowest quintile (HR, 0.66, 95% CI, 0.53-0.82, P < 0.01). Several types of vegetables appeared to be the strongest cancer fighters: cruciferous (broccoli, cauliflower), lettuce, legumes, and carrots. These kinds of vegetables were also linked to lower rates of chronic liver disease mortality (all P < 0.01), as was total vegetable intake for the top quintile versus the lowest quintile (HR, 0.60, 95% CI, 0.49-0.74, P = < 0.01).

“A one-cup increase (8 oz or 225 g) in vegetable intake was associated with about 20% decreased risk of liver cancer incidence and chronic liver mortality,” Zhao said.

There was no statistically significant link between fruit consumption and liver cancer or chronic liver disease mortality.

The findings provide more insight into diet and liver disease, Zhao said. “Chronic liver disease, which predisposes to liver cancer, is the tenth cause of death worldwide, causing two million deaths each year. It shares some etiological processes with liver cancer. Therefore, examining both chronic liver disease mortality and liver cancer incidence in our study may provide a more general picture for the prevention of liver diseases.”

As for limitations, both studies are based on self-reports about food consumption, which can be unreliable, and the subjects in the fruit/vegetable analysis were mainly of European origin.

The authors of both studies report no relevant disclosures. No funding is reported for either study.

Because they have detected sluggishness in hospital diagnoses, researchers have developed an algorithm to help clinicians determine whether patients have acquired hemophilia A (AHA), a rare bleeding disorder that mainly affects elderly men with medical problems.

“A simple algorithm for unexplained bleeding might be helpful to emergency department physicians and other frontline workers to improve recognition of the disease,” said Amar Kelkar, MD, a fellow at the Dana-Farber Cancer Institute, Boston, and corresponding author of “Time is blood: The impact of diagnostic delays on acquired hemophilia A,” a report that appeared in the journal Cureus.

According to Dr. Kelkar, AHA is an autoimmune disease caused by the formation of autoantibodies against factor VIII (FVIII). “Classically, patients present with various forms of bleeding symptoms, including extensive bruising, spontaneous prolonged or persistent bleeding, and blood in the urine. These symptoms are usually accompanied by a prolonged activated partial thromboplastin time (aPTT) test,” he said in an interview. “While this is a rare diagnosis to be seen in primary, critical, or emergency care, it’s a disease that most hematologists should have seen and managed before.”

For the new study, researchers retrospectively tracked patients with AHA at the OSF Healthcare System in Illinois from 2010 to 2017. They focused on six patients (mean age, 79.5; male = 5). Cancer was considered a cause in four cases, and autoimmune disease in one. The sixth case was idiopathic. Five of the six patients died, with all but one death related to bleeding.

The researchers note that they saw more cases than expected (6 per 2.1 million vs. an estimated incidence of 1.48 per 1 million per year), although they attributed this high incidence to the population being made up of older hospitalized patients. In fact, Dr. Kelkar said, researchers believe this is an undercount reflecting diagnostic misses.

The median time to diagnosis was 14 days, the authors report, reflecting other studies that have also shown delays. Pseudo-thrombosis and preexisting anticoagulant therapy likely contribute to the diagnostic delays, they write.

In their new report, the authors developed an algorithm to speed diagnosis.

“The initial step is the identification of a patient with new, unexplained bleeding,” they write. “In the setting of unexplained bleeding, a detailed clinical history, including medication use, along with a thorough physical examination is critical. Prompt primary laboratory testing should include a complete blood count, a metabolic panel including creatinine and bilirubin, and coagulation testing including aPTT and prothrombin time with international normalized ratio (PT/INR). A resulting isolated aPTT elevation will initiate subsequent steps. Early inpatient hematology consultation is recommended.”

The authors add: “An important point to highlight is that we recommend concurrently ordering an aPTT mixing study and a factor VIII activity (FVIII:C) once a prolonged aPTT is confirmed. This may decrease the time to initiate treatment and improve patient outcomes. If the mixing study result is abnormal with low FVIII:C, hemostatic treatment could be initiated with concurrent confirmatory Bethesda assay or anti-FVIII ELISA, preventing further delay in patient recovery and hopefully reducing potential complications. If there is limited availability of specialty testing or prolonged delays in getting test results, such as for FVIII:C, or an inability to confirm a diagnosis at any stage of the algorithm, transferring the patient to a higher level of care with these laboratory and hematology services should be strongly considered.”

The authors also note that “when the diagnostic delay is greater than 1 month, there will be a significant increase in the days that the patient is required to be on hemostatic therapy, compared to diagnosis before 1 month (23.8 ± 13 vs. 7.6 ± 5.7 days, respectively; P = .003).”

The algorithm is meant to be widely available, Dr. Kelkar said. “That is why we targeted an open-source, general medicine journal like Cureus.”

Jerome Teitel, MD, a hematologist with St. Michael’s Hospital in Toronto, said in an interview that the algorithm “might be a useful guide for initial investigation at community hospitals.”

However, he recommended against emphasizing the use of mixing studies. They are “often ambiguous and just delay ordering the definitive tests (FVIII activity and inhibitor assay), which will need to be done regardless,” he said. “The most important message should be that patients with AHA should be referred to, or at least comanaged with, a hematologist who has specific experience and expertise in the field, and who will likely have access to specialized coagulation tests with short turnaround times.”

Another hematologist, George M. Rodgers III, MD, of the University of Utah, Salt Lake City, said in an interview that the algorithm is appropriate for the evaluation of possible AHA. “Patients with the disorder who present with minor bleeding are not evaluated with high priority by physicians,” he said. “Patients with bleeding and a prolonged PTT should be taken very seriously because AHA patients can develop spontaneous fatal bleeding.”

No study funding is reported. The authors, Dr. Teitel, and Dr. Rodgers report no relevant disclosures.

Because they have detected sluggishness in hospital diagnoses, researchers have developed an algorithm to help clinicians determine whether patients have acquired hemophilia A (AHA), a rare bleeding disorder that mainly affects elderly men with medical problems.

“A simple algorithm for unexplained bleeding might be helpful to emergency department physicians and other frontline workers to improve recognition of the disease,” said Amar Kelkar, MD, a fellow at the Dana-Farber Cancer Institute, Boston, and corresponding author of “Time is blood: The impact of diagnostic delays on acquired hemophilia A,” a report that appeared in the journal Cureus.

According to Dr. Kelkar, AHA is an autoimmune disease caused by the formation of autoantibodies against factor VIII (FVIII). “Classically, patients present with various forms of bleeding symptoms, including extensive bruising, spontaneous prolonged or persistent bleeding, and blood in the urine. These symptoms are usually accompanied by a prolonged activated partial thromboplastin time (aPTT) test,” he said in an interview. “While this is a rare diagnosis to be seen in primary, critical, or emergency care, it’s a disease that most hematologists should have seen and managed before.”

For the new study, researchers retrospectively tracked patients with AHA at the OSF Healthcare System in Illinois from 2010 to 2017. They focused on six patients (mean age, 79.5; male = 5). Cancer was considered a cause in four cases, and autoimmune disease in one. The sixth case was idiopathic. Five of the six patients died, with all but one death related to bleeding.

The researchers note that they saw more cases than expected (6 per 2.1 million vs. an estimated incidence of 1.48 per 1 million per year), although they attributed this high incidence to the population being made up of older hospitalized patients. In fact, Dr. Kelkar said, researchers believe this is an undercount reflecting diagnostic misses.

The median time to diagnosis was 14 days, the authors report, reflecting other studies that have also shown delays. Pseudo-thrombosis and preexisting anticoagulant therapy likely contribute to the diagnostic delays, they write.

In their new report, the authors developed an algorithm to speed diagnosis.

“The initial step is the identification of a patient with new, unexplained bleeding,” they write. “In the setting of unexplained bleeding, a detailed clinical history, including medication use, along with a thorough physical examination is critical. Prompt primary laboratory testing should include a complete blood count, a metabolic panel including creatinine and bilirubin, and coagulation testing including aPTT and prothrombin time with international normalized ratio (PT/INR). A resulting isolated aPTT elevation will initiate subsequent steps. Early inpatient hematology consultation is recommended.”

The authors add: “An important point to highlight is that we recommend concurrently ordering an aPTT mixing study and a factor VIII activity (FVIII:C) once a prolonged aPTT is confirmed. This may decrease the time to initiate treatment and improve patient outcomes. If the mixing study result is abnormal with low FVIII:C, hemostatic treatment could be initiated with concurrent confirmatory Bethesda assay or anti-FVIII ELISA, preventing further delay in patient recovery and hopefully reducing potential complications. If there is limited availability of specialty testing or prolonged delays in getting test results, such as for FVIII:C, or an inability to confirm a diagnosis at any stage of the algorithm, transferring the patient to a higher level of care with these laboratory and hematology services should be strongly considered.”

The authors also note that “when the diagnostic delay is greater than 1 month, there will be a significant increase in the days that the patient is required to be on hemostatic therapy, compared to diagnosis before 1 month (23.8 ± 13 vs. 7.6 ± 5.7 days, respectively; P = .003).”

The algorithm is meant to be widely available, Dr. Kelkar said. “That is why we targeted an open-source, general medicine journal like Cureus.”

Jerome Teitel, MD, a hematologist with St. Michael’s Hospital in Toronto, said in an interview that the algorithm “might be a useful guide for initial investigation at community hospitals.”

However, he recommended against emphasizing the use of mixing studies. They are “often ambiguous and just delay ordering the definitive tests (FVIII activity and inhibitor assay), which will need to be done regardless,” he said. “The most important message should be that patients with AHA should be referred to, or at least comanaged with, a hematologist who has specific experience and expertise in the field, and who will likely have access to specialized coagulation tests with short turnaround times.”

Another hematologist, George M. Rodgers III, MD, of the University of Utah, Salt Lake City, said in an interview that the algorithm is appropriate for the evaluation of possible AHA. “Patients with the disorder who present with minor bleeding are not evaluated with high priority by physicians,” he said. “Patients with bleeding and a prolonged PTT should be taken very seriously because AHA patients can develop spontaneous fatal bleeding.”

No study funding is reported. The authors, Dr. Teitel, and Dr. Rodgers report no relevant disclosures.

Because they have detected sluggishness in hospital diagnoses, researchers have developed an algorithm to help clinicians determine whether patients have acquired hemophilia A (AHA), a rare bleeding disorder that mainly affects elderly men with medical problems.

“A simple algorithm for unexplained bleeding might be helpful to emergency department physicians and other frontline workers to improve recognition of the disease,” said Amar Kelkar, MD, a fellow at the Dana-Farber Cancer Institute, Boston, and corresponding author of “Time is blood: The impact of diagnostic delays on acquired hemophilia A,” a report that appeared in the journal Cureus.

According to Dr. Kelkar, AHA is an autoimmune disease caused by the formation of autoantibodies against factor VIII (FVIII). “Classically, patients present with various forms of bleeding symptoms, including extensive bruising, spontaneous prolonged or persistent bleeding, and blood in the urine. These symptoms are usually accompanied by a prolonged activated partial thromboplastin time (aPTT) test,” he said in an interview. “While this is a rare diagnosis to be seen in primary, critical, or emergency care, it’s a disease that most hematologists should have seen and managed before.”

For the new study, researchers retrospectively tracked patients with AHA at the OSF Healthcare System in Illinois from 2010 to 2017. They focused on six patients (mean age, 79.5; male = 5). Cancer was considered a cause in four cases, and autoimmune disease in one. The sixth case was idiopathic. Five of the six patients died, with all but one death related to bleeding.

The researchers note that they saw more cases than expected (6 per 2.1 million vs. an estimated incidence of 1.48 per 1 million per year), although they attributed this high incidence to the population being made up of older hospitalized patients. In fact, Dr. Kelkar said, researchers believe this is an undercount reflecting diagnostic misses.

The median time to diagnosis was 14 days, the authors report, reflecting other studies that have also shown delays. Pseudo-thrombosis and preexisting anticoagulant therapy likely contribute to the diagnostic delays, they write.

In their new report, the authors developed an algorithm to speed diagnosis.

“The initial step is the identification of a patient with new, unexplained bleeding,” they write. “In the setting of unexplained bleeding, a detailed clinical history, including medication use, along with a thorough physical examination is critical. Prompt primary laboratory testing should include a complete blood count, a metabolic panel including creatinine and bilirubin, and coagulation testing including aPTT and prothrombin time with international normalized ratio (PT/INR). A resulting isolated aPTT elevation will initiate subsequent steps. Early inpatient hematology consultation is recommended.”

The authors add: “An important point to highlight is that we recommend concurrently ordering an aPTT mixing study and a factor VIII activity (FVIII:C) once a prolonged aPTT is confirmed. This may decrease the time to initiate treatment and improve patient outcomes. If the mixing study result is abnormal with low FVIII:C, hemostatic treatment could be initiated with concurrent confirmatory Bethesda assay or anti-FVIII ELISA, preventing further delay in patient recovery and hopefully reducing potential complications. If there is limited availability of specialty testing or prolonged delays in getting test results, such as for FVIII:C, or an inability to confirm a diagnosis at any stage of the algorithm, transferring the patient to a higher level of care with these laboratory and hematology services should be strongly considered.”

The authors also note that “when the diagnostic delay is greater than 1 month, there will be a significant increase in the days that the patient is required to be on hemostatic therapy, compared to diagnosis before 1 month (23.8 ± 13 vs. 7.6 ± 5.7 days, respectively; P = .003).”

The algorithm is meant to be widely available, Dr. Kelkar said. “That is why we targeted an open-source, general medicine journal like Cureus.”

Jerome Teitel, MD, a hematologist with St. Michael’s Hospital in Toronto, said in an interview that the algorithm “might be a useful guide for initial investigation at community hospitals.”

However, he recommended against emphasizing the use of mixing studies. They are “often ambiguous and just delay ordering the definitive tests (FVIII activity and inhibitor assay), which will need to be done regardless,” he said. “The most important message should be that patients with AHA should be referred to, or at least comanaged with, a hematologist who has specific experience and expertise in the field, and who will likely have access to specialized coagulation tests with short turnaround times.”

Another hematologist, George M. Rodgers III, MD, of the University of Utah, Salt Lake City, said in an interview that the algorithm is appropriate for the evaluation of possible AHA. “Patients with the disorder who present with minor bleeding are not evaluated with high priority by physicians,” he said. “Patients with bleeding and a prolonged PTT should be taken very seriously because AHA patients can develop spontaneous fatal bleeding.”

No study funding is reported. The authors, Dr. Teitel, and Dr. Rodgers report no relevant disclosures.

More than one in seven patients with breast cancer saw their financial status deteriorate within the first years after their diagnosis, a new study found. Factors like disease severity and treatment type didn’t seem to have an impact on financial status.

The findings, presented at the annual meeting of the American Association for Cancer Research, were unexpected. “We were surprised that we did not find that patients who received more aggressive therapies were more likely to experience worsening financial concerns,” said corresponding author and medical oncologist Kathryn J. Ruddy, MD, of the Mayo Clinici in Rochester, Minn.

The study was undertaken to understand the financial stress facing patients with breast cancer. The question was whether individual or disease factors, or both, were at play.

The study is based on results from the Mayo Clinic Breast Disease Registry, a prospective cohort of patient who were at Mayo Clinic Rochester. Participants answered questions about their finances at baseline and then again at annual follow-ups.

Researchers examined survey findings from 1,957 patients (mean age 58.5, 99.1% female, 95.4% White, 54.9% bachelor degree or higher) who answered questions at least twice from 2015-2020. The average time between diagnosis and the most recent follow-up was 25.6 months.

Of the 1,957 patients, 357 (18.2%) said their finances deteriorated as measured by a 1 point or higher decline on a 10-point scale.

There was no statistically significant link between deteriorating finances and age, race, employment status, stage of cancer at diagnosis, type of cancer, or treatment type. There was a slight link between deteriorating finances and reporting that they were in the category of “pay bills, no money for special things” near diagnosis.

Other research has suggested that breast cancer may not disrupt finances to a large extent, at least early on. Earlier in 2022, Stanford (Calif.) University researchers reported the results of a survey of 273 breast and gynecologic cancer patients who were surveyed about their finances at a mean of 3.4 years after diagnosis. While one-third said their cancer caused career changes, the study described overall financial toxicity as mild.

In regard to limitations, the subject population of the new study is overwhelmingly White, and the finances were self-reported by those who participated in the survey. Also, “because our participants were recruited at a tertiary medical center, there were relatively financially secure at baseline,” Dr. Ruddy said. “More financial hardship would be expected in a more financially diverse population.”

In an interview, Cathy Bradley, PhD, associate dean for research at the University of Colorado at Denver and deputy director of the University of Colorado Cancer Center, both in Aurora, praised the study as “an important start toward assessing financial burden in the clinic. Having more universal assessments in the clinic would remove stigma.”

She cautioned about interpreting a seemingly low number of patients whose financial situation worsened. “This was for a single site where there is a high rate of health insurance either through Medicare or Medicaid. There may be some selection bias as well given that Mayo may attract a wealthier patient population. Most women completed treatment and may not have been on long-term therapies.”

Moving forward, Dr. Ruddy said, “we hope to study cost of oncologic care in more geographically and financially diverse populations with breast cancer and other cancers.”

The study was funded by the Breast Cancer Research Foundation and National Cancer Institute. The study authors and Dr. Ruddy report no relevant disclosures.

More than one in seven patients with breast cancer saw their financial status deteriorate within the first years after their diagnosis, a new study found. Factors like disease severity and treatment type didn’t seem to have an impact on financial status.

The findings, presented at the annual meeting of the American Association for Cancer Research, were unexpected. “We were surprised that we did not find that patients who received more aggressive therapies were more likely to experience worsening financial concerns,” said corresponding author and medical oncologist Kathryn J. Ruddy, MD, of the Mayo Clinici in Rochester, Minn.

The study was undertaken to understand the financial stress facing patients with breast cancer. The question was whether individual or disease factors, or both, were at play.

The study is based on results from the Mayo Clinic Breast Disease Registry, a prospective cohort of patient who were at Mayo Clinic Rochester. Participants answered questions about their finances at baseline and then again at annual follow-ups.

Researchers examined survey findings from 1,957 patients (mean age 58.5, 99.1% female, 95.4% White, 54.9% bachelor degree or higher) who answered questions at least twice from 2015-2020. The average time between diagnosis and the most recent follow-up was 25.6 months.

Of the 1,957 patients, 357 (18.2%) said their finances deteriorated as measured by a 1 point or higher decline on a 10-point scale.

There was no statistically significant link between deteriorating finances and age, race, employment status, stage of cancer at diagnosis, type of cancer, or treatment type. There was a slight link between deteriorating finances and reporting that they were in the category of “pay bills, no money for special things” near diagnosis.

Other research has suggested that breast cancer may not disrupt finances to a large extent, at least early on. Earlier in 2022, Stanford (Calif.) University researchers reported the results of a survey of 273 breast and gynecologic cancer patients who were surveyed about their finances at a mean of 3.4 years after diagnosis. While one-third said their cancer caused career changes, the study described overall financial toxicity as mild.

In regard to limitations, the subject population of the new study is overwhelmingly White, and the finances were self-reported by those who participated in the survey. Also, “because our participants were recruited at a tertiary medical center, there were relatively financially secure at baseline,” Dr. Ruddy said. “More financial hardship would be expected in a more financially diverse population.”

In an interview, Cathy Bradley, PhD, associate dean for research at the University of Colorado at Denver and deputy director of the University of Colorado Cancer Center, both in Aurora, praised the study as “an important start toward assessing financial burden in the clinic. Having more universal assessments in the clinic would remove stigma.”

She cautioned about interpreting a seemingly low number of patients whose financial situation worsened. “This was for a single site where there is a high rate of health insurance either through Medicare or Medicaid. There may be some selection bias as well given that Mayo may attract a wealthier patient population. Most women completed treatment and may not have been on long-term therapies.”

Moving forward, Dr. Ruddy said, “we hope to study cost of oncologic care in more geographically and financially diverse populations with breast cancer and other cancers.”

The study was funded by the Breast Cancer Research Foundation and National Cancer Institute. The study authors and Dr. Ruddy report no relevant disclosures.

More than one in seven patients with breast cancer saw their financial status deteriorate within the first years after their diagnosis, a new study found. Factors like disease severity and treatment type didn’t seem to have an impact on financial status.

The findings, presented at the annual meeting of the American Association for Cancer Research, were unexpected. “We were surprised that we did not find that patients who received more aggressive therapies were more likely to experience worsening financial concerns,” said corresponding author and medical oncologist Kathryn J. Ruddy, MD, of the Mayo Clinici in Rochester, Minn.

The study was undertaken to understand the financial stress facing patients with breast cancer. The question was whether individual or disease factors, or both, were at play.

The study is based on results from the Mayo Clinic Breast Disease Registry, a prospective cohort of patient who were at Mayo Clinic Rochester. Participants answered questions about their finances at baseline and then again at annual follow-ups.

Researchers examined survey findings from 1,957 patients (mean age 58.5, 99.1% female, 95.4% White, 54.9% bachelor degree or higher) who answered questions at least twice from 2015-2020. The average time between diagnosis and the most recent follow-up was 25.6 months.

Of the 1,957 patients, 357 (18.2%) said their finances deteriorated as measured by a 1 point or higher decline on a 10-point scale.

There was no statistically significant link between deteriorating finances and age, race, employment status, stage of cancer at diagnosis, type of cancer, or treatment type. There was a slight link between deteriorating finances and reporting that they were in the category of “pay bills, no money for special things” near diagnosis.

Other research has suggested that breast cancer may not disrupt finances to a large extent, at least early on. Earlier in 2022, Stanford (Calif.) University researchers reported the results of a survey of 273 breast and gynecologic cancer patients who were surveyed about their finances at a mean of 3.4 years after diagnosis. While one-third said their cancer caused career changes, the study described overall financial toxicity as mild.

In regard to limitations, the subject population of the new study is overwhelmingly White, and the finances were self-reported by those who participated in the survey. Also, “because our participants were recruited at a tertiary medical center, there were relatively financially secure at baseline,” Dr. Ruddy said. “More financial hardship would be expected in a more financially diverse population.”

In an interview, Cathy Bradley, PhD, associate dean for research at the University of Colorado at Denver and deputy director of the University of Colorado Cancer Center, both in Aurora, praised the study as “an important start toward assessing financial burden in the clinic. Having more universal assessments in the clinic would remove stigma.”

She cautioned about interpreting a seemingly low number of patients whose financial situation worsened. “This was for a single site where there is a high rate of health insurance either through Medicare or Medicaid. There may be some selection bias as well given that Mayo may attract a wealthier patient population. Most women completed treatment and may not have been on long-term therapies.”

Moving forward, Dr. Ruddy said, “we hope to study cost of oncologic care in more geographically and financially diverse populations with breast cancer and other cancers.”

The study was funded by the Breast Cancer Research Foundation and National Cancer Institute. The study authors and Dr. Ruddy report no relevant disclosures.

Researchers have demonstrated that diet supplementation with high-dose omega-3 fatty acids can lead to a decrease in potentially dangerous FOXA1 in benign breast tissue, potentially pointing the way toward the use of the pioneer transcription factor as a helpful biomarker for breast cancer researchers.

The findings were released at the annual meeting of the American Association for Cancer Research.

In the study, researchers who were led by Bruce F. Kimler, PhD, a radiation biologist and breast cancer researcher at the University of Kansas Medical Center, Kansas City, examined benign breast tissue cells aspirated from 12 women (mean age, 53 years; 7 on low-dose hormone replacement) before and after 6 months of high-dose omega-3 fatty acid supplementation. After the supplementation, FOXA1 positive cells fell in 11 of 12 women (P = .019). “There was a robust linear relationship between stain positivity for FOXA1 and AGR2,” the researchers reported (P < .001).

Increased FOXA1 activity along with GRHL2) transcription factor can boost endocrine resistance, while omega-3 fatty acids can reduce it.

In an interview, Robert S. Chapkin, PhD, the Allen Endowed Chair in Nutrition and Chronic Disease Prevention at Texas A&M University, College Station, said it’s important to examine the value of omega-3 fatty acid supplementation, and the understanding of biomarkers is crucial. “Omega 3 fatty acids are pleiotropic, dose dependent, and likely impact multiple signaling mechanisms in select cells types and cancer contexts. The key is to dissect out the highest impact targets and pursue them in the context of preclinical and clinical studies.”

However, he said, “in many cases, the lack of a mechanistic understanding detracts from the merit of the work.”

Studies like this are useful in the development of clinical trials to test the value of high-dose omega-3 fatty acids in breast cancer prevention trials, said Carol Fabian, MD, a breast medical oncologist with the University of Kansas Medical Center, and the study’s first author.

“They help us understand both what dose will be needed and biomarkers that will likely be helpful in predicting response. Early-phase trials with biomarker modulation as a primary endpoint are generally necessary to make sure you have the right dose for the target population prior to committing to a long-term cancer incidence study involving thousands of women and tens of millions of dollars,” she said.

What’s next? “This work was done on reserved specimens from a prior pilot trial,” Dr. Fabian said. “We need a placebo-controlled study to know for sure that omega-3 FA in a dose of about 3.2g daily, or about 2% of calories, modulates FOXA1 and/or AGR2 in postmenopausal women.”

Previously, she said, the researchers “found that high dose omega-3 administered to overweight peri- and postmenopausal high-risk women undergoing a 6-month weight loss intervention increased the number of systemic risk biomarkers which were favorably modulated compared to placebo despite the same median weight loss in each group [–10%],” Dr. Fabian said. “We want to duplicate that finding in a larger study as well as determine if omega-3 fatty acids can block tamoxifen-induced increases in AGR2 associated with endocrine resistance.”

The study was funded by the Breast Cancer Research Foundation, the Morris Family Foundation, and the University of Kansas Cancer Center. The authors and Chapkin report no relevant disclosures.

Researchers have demonstrated that diet supplementation with high-dose omega-3 fatty acids can lead to a decrease in potentially dangerous FOXA1 in benign breast tissue, potentially pointing the way toward the use of the pioneer transcription factor as a helpful biomarker for breast cancer researchers.

The findings were released at the annual meeting of the American Association for Cancer Research.

In the study, researchers who were led by Bruce F. Kimler, PhD, a radiation biologist and breast cancer researcher at the University of Kansas Medical Center, Kansas City, examined benign breast tissue cells aspirated from 12 women (mean age, 53 years; 7 on low-dose hormone replacement) before and after 6 months of high-dose omega-3 fatty acid supplementation. After the supplementation, FOXA1 positive cells fell in 11 of 12 women (P = .019). “There was a robust linear relationship between stain positivity for FOXA1 and AGR2,” the researchers reported (P < .001).

Increased FOXA1 activity along with GRHL2) transcription factor can boost endocrine resistance, while omega-3 fatty acids can reduce it.

In an interview, Robert S. Chapkin, PhD, the Allen Endowed Chair in Nutrition and Chronic Disease Prevention at Texas A&M University, College Station, said it’s important to examine the value of omega-3 fatty acid supplementation, and the understanding of biomarkers is crucial. “Omega 3 fatty acids are pleiotropic, dose dependent, and likely impact multiple signaling mechanisms in select cells types and cancer contexts. The key is to dissect out the highest impact targets and pursue them in the context of preclinical and clinical studies.”

However, he said, “in many cases, the lack of a mechanistic understanding detracts from the merit of the work.”

Studies like this are useful in the development of clinical trials to test the value of high-dose omega-3 fatty acids in breast cancer prevention trials, said Carol Fabian, MD, a breast medical oncologist with the University of Kansas Medical Center, and the study’s first author.

“They help us understand both what dose will be needed and biomarkers that will likely be helpful in predicting response. Early-phase trials with biomarker modulation as a primary endpoint are generally necessary to make sure you have the right dose for the target population prior to committing to a long-term cancer incidence study involving thousands of women and tens of millions of dollars,” she said.

What’s next? “This work was done on reserved specimens from a prior pilot trial,” Dr. Fabian said. “We need a placebo-controlled study to know for sure that omega-3 FA in a dose of about 3.2g daily, or about 2% of calories, modulates FOXA1 and/or AGR2 in postmenopausal women.”

Previously, she said, the researchers “found that high dose omega-3 administered to overweight peri- and postmenopausal high-risk women undergoing a 6-month weight loss intervention increased the number of systemic risk biomarkers which were favorably modulated compared to placebo despite the same median weight loss in each group [–10%],” Dr. Fabian said. “We want to duplicate that finding in a larger study as well as determine if omega-3 fatty acids can block tamoxifen-induced increases in AGR2 associated with endocrine resistance.”

The study was funded by the Breast Cancer Research Foundation, the Morris Family Foundation, and the University of Kansas Cancer Center. The authors and Chapkin report no relevant disclosures.

Researchers have demonstrated that diet supplementation with high-dose omega-3 fatty acids can lead to a decrease in potentially dangerous FOXA1 in benign breast tissue, potentially pointing the way toward the use of the pioneer transcription factor as a helpful biomarker for breast cancer researchers.

The findings were released at the annual meeting of the American Association for Cancer Research.

In the study, researchers who were led by Bruce F. Kimler, PhD, a radiation biologist and breast cancer researcher at the University of Kansas Medical Center, Kansas City, examined benign breast tissue cells aspirated from 12 women (mean age, 53 years; 7 on low-dose hormone replacement) before and after 6 months of high-dose omega-3 fatty acid supplementation. After the supplementation, FOXA1 positive cells fell in 11 of 12 women (P = .019). “There was a robust linear relationship between stain positivity for FOXA1 and AGR2,” the researchers reported (P < .001).

Increased FOXA1 activity along with GRHL2) transcription factor can boost endocrine resistance, while omega-3 fatty acids can reduce it.

In an interview, Robert S. Chapkin, PhD, the Allen Endowed Chair in Nutrition and Chronic Disease Prevention at Texas A&M University, College Station, said it’s important to examine the value of omega-3 fatty acid supplementation, and the understanding of biomarkers is crucial. “Omega 3 fatty acids are pleiotropic, dose dependent, and likely impact multiple signaling mechanisms in select cells types and cancer contexts. The key is to dissect out the highest impact targets and pursue them in the context of preclinical and clinical studies.”

However, he said, “in many cases, the lack of a mechanistic understanding detracts from the merit of the work.”

Studies like this are useful in the development of clinical trials to test the value of high-dose omega-3 fatty acids in breast cancer prevention trials, said Carol Fabian, MD, a breast medical oncologist with the University of Kansas Medical Center, and the study’s first author.

“They help us understand both what dose will be needed and biomarkers that will likely be helpful in predicting response. Early-phase trials with biomarker modulation as a primary endpoint are generally necessary to make sure you have the right dose for the target population prior to committing to a long-term cancer incidence study involving thousands of women and tens of millions of dollars,” she said.

What’s next? “This work was done on reserved specimens from a prior pilot trial,” Dr. Fabian said. “We need a placebo-controlled study to know for sure that omega-3 FA in a dose of about 3.2g daily, or about 2% of calories, modulates FOXA1 and/or AGR2 in postmenopausal women.”

Previously, she said, the researchers “found that high dose omega-3 administered to overweight peri- and postmenopausal high-risk women undergoing a 6-month weight loss intervention increased the number of systemic risk biomarkers which were favorably modulated compared to placebo despite the same median weight loss in each group [–10%],” Dr. Fabian said. “We want to duplicate that finding in a larger study as well as determine if omega-3 fatty acids can block tamoxifen-induced increases in AGR2 associated with endocrine resistance.”

The study was funded by the Breast Cancer Research Foundation, the Morris Family Foundation, and the University of Kansas Cancer Center. The authors and Chapkin report no relevant disclosures.

New research suggests that chemotherapy treatments for recurrent high-grade gliomas indicated by an assay-guided tool called ChemoID can boost median survival, compared with physician choice.

The randomized, phase 3 trial results were presented at the annual meeting of the American Association for Cancer Research.

Over a median follow-up of 9 months, median overall survival in the ChemoID group was 12.5 months (95% confidence interval, 10.2-14.7), compared with 9 months (95% CI, 4.2-13.8) in the group whose treatments were chosen by physicians (P = .010).

“While the prognosis is very dismal, we’re still providing a 3.5-month benefit in the guided arm versus physician choice,” said study coauthor Jagan Valluri, PhD, professor of cellular biology and integrative medicine at Marshall University, Huntington, W. Va.

As Dr. Valluri noted, patients with recurrent high-grade gliomas typically have failed radiation and are left with poor prognoses. Fewer than one in four patients respond to chemotherapy at this point, he said, and the response is inconsistent from patient to patient.

“We developed ChemoID since cancer is very unique,” he said, “and any kind of chemotherapy should be tailored to each individual patient on a case-by-case basis.”

The ChemoID tool, a proprietary assay, tests the response of patient cells to various chemotherapy treatments. A test costs $3,500, and some insurers cover it, Dr. Valluri said.

For the new study, researchers randomly assigned 50 patients with grade III/IV recurrent glioma to be treated with chemotherapy chosen by physicians or chemotherapy recommended by the ChemoID tool.

Risk of death in the ChemoID group was lower than in the physician-guided group (hazard ratio, 0.44; 95% CI, 0.24-0.81; P = .008), and median progression-free survival was higher in the ChemoID group (10.1 months vs. 3.5 months; 95% CI, 4.8-15.4 vs. 1.9-5.1; HR, 0.25; 95% CI, 0.14-0.44; P < .001).

“We want the treating physician to have actionable tools in front of them before they treat the patient,” Dr. Valluri said. “We want this assay to become mainstream and part of the standard care workup.”

The study is funded by Cordgenics, where Dr. Valluri serves as chief operating officer.

New research suggests that chemotherapy treatments for recurrent high-grade gliomas indicated by an assay-guided tool called ChemoID can boost median survival, compared with physician choice.

The randomized, phase 3 trial results were presented at the annual meeting of the American Association for Cancer Research.

Over a median follow-up of 9 months, median overall survival in the ChemoID group was 12.5 months (95% confidence interval, 10.2-14.7), compared with 9 months (95% CI, 4.2-13.8) in the group whose treatments were chosen by physicians (P = .010).

“While the prognosis is very dismal, we’re still providing a 3.5-month benefit in the guided arm versus physician choice,” said study coauthor Jagan Valluri, PhD, professor of cellular biology and integrative medicine at Marshall University, Huntington, W. Va.

As Dr. Valluri noted, patients with recurrent high-grade gliomas typically have failed radiation and are left with poor prognoses. Fewer than one in four patients respond to chemotherapy at this point, he said, and the response is inconsistent from patient to patient.

“We developed ChemoID since cancer is very unique,” he said, “and any kind of chemotherapy should be tailored to each individual patient on a case-by-case basis.”

The ChemoID tool, a proprietary assay, tests the response of patient cells to various chemotherapy treatments. A test costs $3,500, and some insurers cover it, Dr. Valluri said.

For the new study, researchers randomly assigned 50 patients with grade III/IV recurrent glioma to be treated with chemotherapy chosen by physicians or chemotherapy recommended by the ChemoID tool.

Risk of death in the ChemoID group was lower than in the physician-guided group (hazard ratio, 0.44; 95% CI, 0.24-0.81; P = .008), and median progression-free survival was higher in the ChemoID group (10.1 months vs. 3.5 months; 95% CI, 4.8-15.4 vs. 1.9-5.1; HR, 0.25; 95% CI, 0.14-0.44; P < .001).

“We want the treating physician to have actionable tools in front of them before they treat the patient,” Dr. Valluri said. “We want this assay to become mainstream and part of the standard care workup.”

The study is funded by Cordgenics, where Dr. Valluri serves as chief operating officer.

New research suggests that chemotherapy treatments for recurrent high-grade gliomas indicated by an assay-guided tool called ChemoID can boost median survival, compared with physician choice.

The randomized, phase 3 trial results were presented at the annual meeting of the American Association for Cancer Research.

Over a median follow-up of 9 months, median overall survival in the ChemoID group was 12.5 months (95% confidence interval, 10.2-14.7), compared with 9 months (95% CI, 4.2-13.8) in the group whose treatments were chosen by physicians (P = .010).

“While the prognosis is very dismal, we’re still providing a 3.5-month benefit in the guided arm versus physician choice,” said study coauthor Jagan Valluri, PhD, professor of cellular biology and integrative medicine at Marshall University, Huntington, W. Va.

As Dr. Valluri noted, patients with recurrent high-grade gliomas typically have failed radiation and are left with poor prognoses. Fewer than one in four patients respond to chemotherapy at this point, he said, and the response is inconsistent from patient to patient.

“We developed ChemoID since cancer is very unique,” he said, “and any kind of chemotherapy should be tailored to each individual patient on a case-by-case basis.”

The ChemoID tool, a proprietary assay, tests the response of patient cells to various chemotherapy treatments. A test costs $3,500, and some insurers cover it, Dr. Valluri said.

For the new study, researchers randomly assigned 50 patients with grade III/IV recurrent glioma to be treated with chemotherapy chosen by physicians or chemotherapy recommended by the ChemoID tool.

Risk of death in the ChemoID group was lower than in the physician-guided group (hazard ratio, 0.44; 95% CI, 0.24-0.81; P = .008), and median progression-free survival was higher in the ChemoID group (10.1 months vs. 3.5 months; 95% CI, 4.8-15.4 vs. 1.9-5.1; HR, 0.25; 95% CI, 0.14-0.44; P < .001).

“We want the treating physician to have actionable tools in front of them before they treat the patient,” Dr. Valluri said. “We want this assay to become mainstream and part of the standard care workup.”

The study is funded by Cordgenics, where Dr. Valluri serves as chief operating officer.

New research suggests that the casirivimab-imdevimab monoclonal antibody treatment for COVID-19 could have been delivered via injection instead of intravenously. There was no statistically significant difference in 28-day hospitalization or death in those treated intravenously and via subcutaneous injection.

The findings, published in JAMA Network Open, aren’t directly relevant at the moment, since the casirivimab-imdevimab treatment was abandoned when it failed to work during the Omicron outbreak. However, they point toward the importance of studying multiple routes of administration, said study lead author and pharmacist Erin K. McCreary, PharmD, of the University of Pittsburgh, in an interview.

“It would be beneficial for all future monoclonal antibodies for COVID-19 to be studied subcutaneously or intramuscularly, if possible, since that’s logistically easier than IV in the outpatient setting,” she said.

According to Dr. McCreary, an outpatient casirivimab-imdevimab treatment was used from 2020 to 2022 to treat higher-risk patients with mild to moderate COVID-19. The treatment was typically given intravenously as recommended by the federal government’s Emergency Use Authorization, she said. Clinical trials of the treatment, according to the study, allowed only IV administration.

“However, during the Delta surge, we were faced with so many patient referrals for treatment and staffing shortages that we couldn’t accommodate every patient unless we switched to [the] subcutaneous route,” Dr. McCreary said. This approach shortened appointment times by 30 minutes vs. infusion, she said.

There are many benefits to subcutaneous administration versus IV, Dr. McCreary said. “You don’t need to start an intravenous line, so you avoid the line kit and the nursing time needed for that. You draw up the drug directly into syringes and inject under the skin, so you avoid the need for a fluid bag to mix the drug in and run intravenously,” she said. “The appointment times are shorter, so you can accommodate more patients per day. Pharmacy interns can give subcutaneous injections, so you avoid the need for a nurse trained in placing intravenous lines.”

The researchers prospectively assigned 1,959 matched adults with mild to moderate COVID-19 to subcutaneous or intravenous treatment. Of 969 patients who received the subcutaneous treatment (mean age, 53.8; 56.4% women), the 28-day rate of hospitalization or death was 3.4%. Of 1,216 patients who received intravenous treatment (mean age, 54.3; 54.4% women), the rate was 1.7%. The difference was not statistically significant (P = .16).

Among 1,306 nontreated controls, 7.0% were hospitalized or died within 28 days (risk ratio = 0.48 vs. subcutaneous treatment group; 95% confidence interval, 0.30-0.80; P = .002).

“We did not find any patients where IV is a must,” Dr. McCreary said. “However, our study wasn’t powered to see a difference in certain subgroups.”

In an interview, University of Toronto internal medicine and pharmacology/toxicology physician Peter Wu, MD, said he agrees that the study has value because it emphasizes the importance of testing whether monoclonal antibodies can be administered in ways other than intravenously.

However, in the larger picture, he said, this may be irrelevant since it’s clear that anti-spike treatments are not holding up against COVID-19 variants.

No study funding is reported. Some study authors reported disclosures outside the submitted work. Dr. Wu has disclosed no relevant financial relationships.

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

New research suggests that the casirivimab-imdevimab monoclonal antibody treatment for COVID-19 could have been delivered via injection instead of intravenously. There was no statistically significant difference in 28-day hospitalization or death in those treated intravenously and via subcutaneous injection.

The findings, published in JAMA Network Open, aren’t directly relevant at the moment, since the casirivimab-imdevimab treatment was abandoned when it failed to work during the Omicron outbreak. However, they point toward the importance of studying multiple routes of administration, said study lead author and pharmacist Erin K. McCreary, PharmD, of the University of Pittsburgh, in an interview.

“It would be beneficial for all future monoclonal antibodies for COVID-19 to be studied subcutaneously or intramuscularly, if possible, since that’s logistically easier than IV in the outpatient setting,” she said.

According to Dr. McCreary, an outpatient casirivimab-imdevimab treatment was used from 2020 to 2022 to treat higher-risk patients with mild to moderate COVID-19. The treatment was typically given intravenously as recommended by the federal government’s Emergency Use Authorization, she said. Clinical trials of the treatment, according to the study, allowed only IV administration.

“However, during the Delta surge, we were faced with so many patient referrals for treatment and staffing shortages that we couldn’t accommodate every patient unless we switched to [the] subcutaneous route,” Dr. McCreary said. This approach shortened appointment times by 30 minutes vs. infusion, she said.

There are many benefits to subcutaneous administration versus IV, Dr. McCreary said. “You don’t need to start an intravenous line, so you avoid the line kit and the nursing time needed for that. You draw up the drug directly into syringes and inject under the skin, so you avoid the need for a fluid bag to mix the drug in and run intravenously,” she said. “The appointment times are shorter, so you can accommodate more patients per day. Pharmacy interns can give subcutaneous injections, so you avoid the need for a nurse trained in placing intravenous lines.”

The researchers prospectively assigned 1,959 matched adults with mild to moderate COVID-19 to subcutaneous or intravenous treatment. Of 969 patients who received the subcutaneous treatment (mean age, 53.8; 56.4% women), the 28-day rate of hospitalization or death was 3.4%. Of 1,216 patients who received intravenous treatment (mean age, 54.3; 54.4% women), the rate was 1.7%. The difference was not statistically significant (P = .16).

Among 1,306 nontreated controls, 7.0% were hospitalized or died within 28 days (risk ratio = 0.48 vs. subcutaneous treatment group; 95% confidence interval, 0.30-0.80; P = .002).

“We did not find any patients where IV is a must,” Dr. McCreary said. “However, our study wasn’t powered to see a difference in certain subgroups.”

In an interview, University of Toronto internal medicine and pharmacology/toxicology physician Peter Wu, MD, said he agrees that the study has value because it emphasizes the importance of testing whether monoclonal antibodies can be administered in ways other than intravenously.

However, in the larger picture, he said, this may be irrelevant since it’s clear that anti-spike treatments are not holding up against COVID-19 variants.

No study funding is reported. Some study authors reported disclosures outside the submitted work. Dr. Wu has disclosed no relevant financial relationships.

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

New research suggests that the casirivimab-imdevimab monoclonal antibody treatment for COVID-19 could have been delivered via injection instead of intravenously. There was no statistically significant difference in 28-day hospitalization or death in those treated intravenously and via subcutaneous injection.

The findings, published in JAMA Network Open, aren’t directly relevant at the moment, since the casirivimab-imdevimab treatment was abandoned when it failed to work during the Omicron outbreak. However, they point toward the importance of studying multiple routes of administration, said study lead author and pharmacist Erin K. McCreary, PharmD, of the University of Pittsburgh, in an interview.

“It would be beneficial for all future monoclonal antibodies for COVID-19 to be studied subcutaneously or intramuscularly, if possible, since that’s logistically easier than IV in the outpatient setting,” she said.

According to Dr. McCreary, an outpatient casirivimab-imdevimab treatment was used from 2020 to 2022 to treat higher-risk patients with mild to moderate COVID-19. The treatment was typically given intravenously as recommended by the federal government’s Emergency Use Authorization, she said. Clinical trials of the treatment, according to the study, allowed only IV administration.

“However, during the Delta surge, we were faced with so many patient referrals for treatment and staffing shortages that we couldn’t accommodate every patient unless we switched to [the] subcutaneous route,” Dr. McCreary said. This approach shortened appointment times by 30 minutes vs. infusion, she said.

There are many benefits to subcutaneous administration versus IV, Dr. McCreary said. “You don’t need to start an intravenous line, so you avoid the line kit and the nursing time needed for that. You draw up the drug directly into syringes and inject under the skin, so you avoid the need for a fluid bag to mix the drug in and run intravenously,” she said. “The appointment times are shorter, so you can accommodate more patients per day. Pharmacy interns can give subcutaneous injections, so you avoid the need for a nurse trained in placing intravenous lines.”

The researchers prospectively assigned 1,959 matched adults with mild to moderate COVID-19 to subcutaneous or intravenous treatment. Of 969 patients who received the subcutaneous treatment (mean age, 53.8; 56.4% women), the 28-day rate of hospitalization or death was 3.4%. Of 1,216 patients who received intravenous treatment (mean age, 54.3; 54.4% women), the rate was 1.7%. The difference was not statistically significant (P = .16).

Among 1,306 nontreated controls, 7.0% were hospitalized or died within 28 days (risk ratio = 0.48 vs. subcutaneous treatment group; 95% confidence interval, 0.30-0.80; P = .002).

“We did not find any patients where IV is a must,” Dr. McCreary said. “However, our study wasn’t powered to see a difference in certain subgroups.”

In an interview, University of Toronto internal medicine and pharmacology/toxicology physician Peter Wu, MD, said he agrees that the study has value because it emphasizes the importance of testing whether monoclonal antibodies can be administered in ways other than intravenously.

However, in the larger picture, he said, this may be irrelevant since it’s clear that anti-spike treatments are not holding up against COVID-19 variants.

No study funding is reported. Some study authors reported disclosures outside the submitted work. Dr. Wu has disclosed no relevant financial relationships.

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