Women's Health

Despite federal legislation doing away with cost-sharing for initial breast cancer screening, out-of-pocket costs for needed follow-up tests remain significant financial barriers for many women.

An analysis of claims data found that women with higher cost-sharing undergo fewer subsequent breast diagnostic tests after an abnormal screening mammogram, compared with peers with lower cost-sharing.

“The chief clinical implication is that women with abnormal mammograms – that is, potentially at risk for cancer – are deciding not to follow-up on diagnostic imaging because of high out-of-pocket costs,” Danny Hughes, PhD, professor, College of Health Solutions, Arizona State University in Phoenix, told this news organization.

One course of action for radiologists is to “strongly communicate the importance of adhering to recommended follow-on testing,” Dr. Hughes said.

Another is to “work to pass national and state legislation, such as recently passed [legislation] in Connecticut, that removes out-of-pocket costs for follow-on diagnostic breast imaging and biopsy in the same way that these patient costs are prohibited for screening mammography,” he suggested.

The study was published online in JAMA Network Open.


 

‘Worrisome’ findings

The Affordable Care Act removed out-of-pocket costs for preventive health care, such as screening mammograms in women aged 40 and over.

However, lingering cost barriers remain for some individuals who have a positive initial screening mammogram and need follow-up tests. For instance, research shows that women in high-deductible plans, which often have higher out-of-pocket costs than other plans, may experience delays in follow-on care, including diagnostic breast imaging.

Dr. Hughes and colleagues examined the association between the degree of patient cost-sharing across different health plans – those dominated by copays, coinsurance, or deductibles as well as those classified as balanced across the three categories – and the use of diagnostic breast cancer imaging after a screening mammogram.

The data came from Optum’s database of administrative health claims for members of large commercial and Medicare Advantage health plans. The team used a machine learning algorithm to rank patient insurance plans by type of cost-sharing.

The sample included 230,845 mostly White (71%) women 40 years and older with no prior history of breast cancer who underwent screening mammography. These women were covered by 22,828 distinct insurance plans associated with roughly 6 million enrollees and nearly 45 million distinct medical claims.

Plans dominated by coinsurance had the lowest average out-of-pocket costs ($945), followed by plans balanced across the three cost-sharing categories ($1,017), plans dominated by copays ($1,020), and plans dominated by deductibles ($1,186).

Compared with women with coinsurance plans, those with copay- and deductible-dominated plans underwent significantly fewer subsequent breast-imaging procedures – 24 and 16 fewer procedures per 1,000 women, respectively.

Use of follow-on breast MRI was nearly 24% lower among women in plans with the highest cost-sharing versus those in plans with the lowest cost-sharing.

The team found no statistically significant difference in breast biopsy use between plan types.

Considering the risks posed by an unconfirmed positive mammogram result, these findings are “startling” and question the efficacy of legislation that eliminated cost-sharing from many preventive services, including screening mammograms, Dr. Hughes and colleagues write.

“Additional policy changes, such as removing cost-sharing for subsequent tests after abnormal screening results or bundling all breast cancer diagnostic testing into a single reimbursement, may provide avenues to mitigate these financial barriers to care,” the authors add.

The authors of an accompanying editorial found the study’s main finding – that some women who have an abnormal result on a mammogram may not get appropriate follow-up because of cost – is “worrisome.” 

“From a population health perspective, failure to complete the screening process limits the program’s effectiveness and likely exacerbates health disparities,” write Ilana Richman, MD, with Yale University, New Haven, Conn., and A. Mark Fendrick, MD, with the University of Michigan, Ann Arbor.

“On an individual level, high out-of-pocket costs may directly contribute to worse health outcomes or require individuals to use scarce financial resources that may otherwise be used for critical items such as food or rent,” Dr. Richman and Dr. Fendrick add. And “the removal of financial barriers for the entire breast cancer screening process has potential to improve total screening uptake and follow-up rates.”

Support for the study was provided by the Harvey L. Neiman Health Policy Institute. Dr. Hughes has reported no relevant financial relationships. Dr. Richman has reported receiving salary support from the Centers for Medicare & Medicaid Services to develop health care quality measures outside the submitted work. Dr. Fendrick has reported serving as a consultant for AbbVie, Amgen, Bayer, CareFirst, BlueCross BlueShield, Centivo, Community Oncology Association, Covered California, EmblemHealth, Exact Sciences, GRAIL, Harvard University, HealthCorum, Hygieia, Johnson & Johnson, MedZed, Merck, Mercer, Montana Health Cooperative, Phathom Pharmaceuticals, Proton Intelligence, RA Capital, Teladoc Health, U.S. Department of Defense, Virginia Center for Health Innovation, Washington Health Benefit Exchange, Wildflower Health, and Yale-New Haven Health System; and serving as a consultant for and holding equity in Health at Scale Technologies, Pair Team, Sempre Health, Silver Fern Health, and Wellth.

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

Despite federal legislation doing away with cost-sharing for initial breast cancer screening, out-of-pocket costs for needed follow-up tests remain significant financial barriers for many women.

An analysis of claims data found that women with higher cost-sharing undergo fewer subsequent breast diagnostic tests after an abnormal screening mammogram, compared with peers with lower cost-sharing.

“The chief clinical implication is that women with abnormal mammograms – that is, potentially at risk for cancer – are deciding not to follow-up on diagnostic imaging because of high out-of-pocket costs,” Danny Hughes, PhD, professor, College of Health Solutions, Arizona State University in Phoenix, told this news organization.

One course of action for radiologists is to “strongly communicate the importance of adhering to recommended follow-on testing,” Dr. Hughes said.

Another is to “work to pass national and state legislation, such as recently passed [legislation] in Connecticut, that removes out-of-pocket costs for follow-on diagnostic breast imaging and biopsy in the same way that these patient costs are prohibited for screening mammography,” he suggested.

The study was published online in JAMA Network Open.


 

‘Worrisome’ findings

The Affordable Care Act removed out-of-pocket costs for preventive health care, such as screening mammograms in women aged 40 and over.

However, lingering cost barriers remain for some individuals who have a positive initial screening mammogram and need follow-up tests. For instance, research shows that women in high-deductible plans, which often have higher out-of-pocket costs than other plans, may experience delays in follow-on care, including diagnostic breast imaging.

Dr. Hughes and colleagues examined the association between the degree of patient cost-sharing across different health plans – those dominated by copays, coinsurance, or deductibles as well as those classified as balanced across the three categories – and the use of diagnostic breast cancer imaging after a screening mammogram.

The data came from Optum’s database of administrative health claims for members of large commercial and Medicare Advantage health plans. The team used a machine learning algorithm to rank patient insurance plans by type of cost-sharing.

The sample included 230,845 mostly White (71%) women 40 years and older with no prior history of breast cancer who underwent screening mammography. These women were covered by 22,828 distinct insurance plans associated with roughly 6 million enrollees and nearly 45 million distinct medical claims.

Plans dominated by coinsurance had the lowest average out-of-pocket costs ($945), followed by plans balanced across the three cost-sharing categories ($1,017), plans dominated by copays ($1,020), and plans dominated by deductibles ($1,186).

Compared with women with coinsurance plans, those with copay- and deductible-dominated plans underwent significantly fewer subsequent breast-imaging procedures – 24 and 16 fewer procedures per 1,000 women, respectively.

Use of follow-on breast MRI was nearly 24% lower among women in plans with the highest cost-sharing versus those in plans with the lowest cost-sharing.

The team found no statistically significant difference in breast biopsy use between plan types.

Considering the risks posed by an unconfirmed positive mammogram result, these findings are “startling” and question the efficacy of legislation that eliminated cost-sharing from many preventive services, including screening mammograms, Dr. Hughes and colleagues write.

“Additional policy changes, such as removing cost-sharing for subsequent tests after abnormal screening results or bundling all breast cancer diagnostic testing into a single reimbursement, may provide avenues to mitigate these financial barriers to care,” the authors add.

The authors of an accompanying editorial found the study’s main finding – that some women who have an abnormal result on a mammogram may not get appropriate follow-up because of cost – is “worrisome.” 

“From a population health perspective, failure to complete the screening process limits the program’s effectiveness and likely exacerbates health disparities,” write Ilana Richman, MD, with Yale University, New Haven, Conn., and A. Mark Fendrick, MD, with the University of Michigan, Ann Arbor.

“On an individual level, high out-of-pocket costs may directly contribute to worse health outcomes or require individuals to use scarce financial resources that may otherwise be used for critical items such as food or rent,” Dr. Richman and Dr. Fendrick add. And “the removal of financial barriers for the entire breast cancer screening process has potential to improve total screening uptake and follow-up rates.”

Support for the study was provided by the Harvey L. Neiman Health Policy Institute. Dr. Hughes has reported no relevant financial relationships. Dr. Richman has reported receiving salary support from the Centers for Medicare & Medicaid Services to develop health care quality measures outside the submitted work. Dr. Fendrick has reported serving as a consultant for AbbVie, Amgen, Bayer, CareFirst, BlueCross BlueShield, Centivo, Community Oncology Association, Covered California, EmblemHealth, Exact Sciences, GRAIL, Harvard University, HealthCorum, Hygieia, Johnson & Johnson, MedZed, Merck, Mercer, Montana Health Cooperative, Phathom Pharmaceuticals, Proton Intelligence, RA Capital, Teladoc Health, U.S. Department of Defense, Virginia Center for Health Innovation, Washington Health Benefit Exchange, Wildflower Health, and Yale-New Haven Health System; and serving as a consultant for and holding equity in Health at Scale Technologies, Pair Team, Sempre Health, Silver Fern Health, and Wellth.

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

Despite federal legislation doing away with cost-sharing for initial breast cancer screening, out-of-pocket costs for needed follow-up tests remain significant financial barriers for many women.

An analysis of claims data found that women with higher cost-sharing undergo fewer subsequent breast diagnostic tests after an abnormal screening mammogram, compared with peers with lower cost-sharing.

“The chief clinical implication is that women with abnormal mammograms – that is, potentially at risk for cancer – are deciding not to follow-up on diagnostic imaging because of high out-of-pocket costs,” Danny Hughes, PhD, professor, College of Health Solutions, Arizona State University in Phoenix, told this news organization.

One course of action for radiologists is to “strongly communicate the importance of adhering to recommended follow-on testing,” Dr. Hughes said.

Another is to “work to pass national and state legislation, such as recently passed [legislation] in Connecticut, that removes out-of-pocket costs for follow-on diagnostic breast imaging and biopsy in the same way that these patient costs are prohibited for screening mammography,” he suggested.

The study was published online in JAMA Network Open.


 

‘Worrisome’ findings

The Affordable Care Act removed out-of-pocket costs for preventive health care, such as screening mammograms in women aged 40 and over.

However, lingering cost barriers remain for some individuals who have a positive initial screening mammogram and need follow-up tests. For instance, research shows that women in high-deductible plans, which often have higher out-of-pocket costs than other plans, may experience delays in follow-on care, including diagnostic breast imaging.

Dr. Hughes and colleagues examined the association between the degree of patient cost-sharing across different health plans – those dominated by copays, coinsurance, or deductibles as well as those classified as balanced across the three categories – and the use of diagnostic breast cancer imaging after a screening mammogram.

The data came from Optum’s database of administrative health claims for members of large commercial and Medicare Advantage health plans. The team used a machine learning algorithm to rank patient insurance plans by type of cost-sharing.

The sample included 230,845 mostly White (71%) women 40 years and older with no prior history of breast cancer who underwent screening mammography. These women were covered by 22,828 distinct insurance plans associated with roughly 6 million enrollees and nearly 45 million distinct medical claims.

Plans dominated by coinsurance had the lowest average out-of-pocket costs ($945), followed by plans balanced across the three cost-sharing categories ($1,017), plans dominated by copays ($1,020), and plans dominated by deductibles ($1,186).

Compared with women with coinsurance plans, those with copay- and deductible-dominated plans underwent significantly fewer subsequent breast-imaging procedures – 24 and 16 fewer procedures per 1,000 women, respectively.

Use of follow-on breast MRI was nearly 24% lower among women in plans with the highest cost-sharing versus those in plans with the lowest cost-sharing.

The team found no statistically significant difference in breast biopsy use between plan types.

Considering the risks posed by an unconfirmed positive mammogram result, these findings are “startling” and question the efficacy of legislation that eliminated cost-sharing from many preventive services, including screening mammograms, Dr. Hughes and colleagues write.

“Additional policy changes, such as removing cost-sharing for subsequent tests after abnormal screening results or bundling all breast cancer diagnostic testing into a single reimbursement, may provide avenues to mitigate these financial barriers to care,” the authors add.

The authors of an accompanying editorial found the study’s main finding – that some women who have an abnormal result on a mammogram may not get appropriate follow-up because of cost – is “worrisome.” 

“From a population health perspective, failure to complete the screening process limits the program’s effectiveness and likely exacerbates health disparities,” write Ilana Richman, MD, with Yale University, New Haven, Conn., and A. Mark Fendrick, MD, with the University of Michigan, Ann Arbor.

“On an individual level, high out-of-pocket costs may directly contribute to worse health outcomes or require individuals to use scarce financial resources that may otherwise be used for critical items such as food or rent,” Dr. Richman and Dr. Fendrick add. And “the removal of financial barriers for the entire breast cancer screening process has potential to improve total screening uptake and follow-up rates.”

Support for the study was provided by the Harvey L. Neiman Health Policy Institute. Dr. Hughes has reported no relevant financial relationships. Dr. Richman has reported receiving salary support from the Centers for Medicare & Medicaid Services to develop health care quality measures outside the submitted work. Dr. Fendrick has reported serving as a consultant for AbbVie, Amgen, Bayer, CareFirst, BlueCross BlueShield, Centivo, Community Oncology Association, Covered California, EmblemHealth, Exact Sciences, GRAIL, Harvard University, HealthCorum, Hygieia, Johnson & Johnson, MedZed, Merck, Mercer, Montana Health Cooperative, Phathom Pharmaceuticals, Proton Intelligence, RA Capital, Teladoc Health, U.S. Department of Defense, Virginia Center for Health Innovation, Washington Health Benefit Exchange, Wildflower Health, and Yale-New Haven Health System; and serving as a consultant for and holding equity in Health at Scale Technologies, Pair Team, Sempre Health, Silver Fern Health, and Wellth.

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

Vaginal swabs are more effective than urine analysis in detecting certain types of sexually transmitted infections, researchers have found.

In the study, which was published online in the Annals of Family Medicine, investigators found that the diagnostic sensitivity of commercially available vaginal swabs was significantly greater than that of urine tests in detecting certain infections, including those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Researchers studied chlamydia and gonorrhea, which are two of the most frequently reported STIs in the United States. Trichomoniasis is the most curable nonviral STI globally, with 156 million cases worldwide in 2016.

The Centers for Disease Control and Prevention has long recommended that vaginal swabs be used to produce optimal samples.

But despite the CDC’s recommendation, urine analysis for these STIs is more commonly used than vaginal swabs among U.S. health care providers.

“We’re using a poor sample type, and we can do better,” said Barbara Van Der Pol, PhD, a professor of medicine and public health at the University of Alabama at Birmingham and an author of the new study, a meta-analysis of 97 studies published between 1995 and 2021.

Vaginal swabs for chlamydia trachomatis had a diagnostic sensitivity of 94.1% (95% confidence interval, 93.2%-94.9%; P < .001), higher than urine testing (86.9%; 95% CI, 85.6%-88.0%; P < .001). The pooled sensitivity estimates for Neisseria gonorrhoeae were 96.5% (95% CI, 94.8%-97.7%; P < .001) for vaginal swabs and 90.7% (95% CI, 88.4%-92.5%; P < .001) for urine specimens.

The difference in pooled sensitivity estimates between vaginal swabs and urine analyses for Trichomonas vaginalis was 98% (95% CI, 97.0%-98.7%; P < .001) for vaginal swabs and 95.1% (95% CI, 93.6%-96.3%) for urine specimens.

STIs included in the study are not typically found in the urethra and appear in urine analyses only if cervical or vaginal cells have dripped into a urine sample. Dr. Van Der Pol and her colleagues estimated that the use of urine samples rather than vaginal swabs may result in more than 400,000 undiagnosed infections annually.

Undiagnosed and untreated STIs can lead to transmissions of the infection as well as infertility and can have negative effects on romantic relationships, according to Dr. Van Der Pol.

Sarah Wood, MD, an attending physician at Children’s Hospital of Philadelphia, said some health care providers may use urine analysis because patients may be more comfortable with this method. The approach also can be more convenient for medical offices: All they must do is hand a specimen container to the patient.

Conversations between clinicians and patients about vaginal swabbing may be considered “sensitive” and the swabbing more invasive, Dr. Wood, an author of an editorial accompanying the journal article, said. Clinicians may also lack awareness that the swab is a more sensitive method of detecting these STIs.

“We all want to do what’s right for our patient, but we often don’t know what’s right for the patient,” Dr. Wood said. “I don’t think people are really aware of a potential real difference in outcomes with one method over the other.”

Dr. Wood advised making STI screening using vaginal swabs more common by “offering universal opt-out screening, so not waiting until you find out if someone’s having sex but just sort of saying, ‘Hey, across our practice, we screen everybody for chlamydia. Is that something that you want to do today?’ That approach sort of takes out the piece of talking about sex, talking about sexual activity.”

Dr. Van Der Pol, who said she has worked in STI diagnostics for 40 years, said she was not surprised by the results and hopes the study changes how samples are collected and used.

“I really hope that it influences practice so that we really start using vaginal swabs, because it gives us better diagnostics for chlamydia and gonorrhea,” Dr. Van Der Pol said.

“Also, then starting to think about comprehensive women’s care in such a way that they actually order other tests on that same sample if a woman is presenting with complaints.”

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

Vaginal swabs are more effective than urine analysis in detecting certain types of sexually transmitted infections, researchers have found.

In the study, which was published online in the Annals of Family Medicine, investigators found that the diagnostic sensitivity of commercially available vaginal swabs was significantly greater than that of urine tests in detecting certain infections, including those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Researchers studied chlamydia and gonorrhea, which are two of the most frequently reported STIs in the United States. Trichomoniasis is the most curable nonviral STI globally, with 156 million cases worldwide in 2016.

The Centers for Disease Control and Prevention has long recommended that vaginal swabs be used to produce optimal samples.

But despite the CDC’s recommendation, urine analysis for these STIs is more commonly used than vaginal swabs among U.S. health care providers.

“We’re using a poor sample type, and we can do better,” said Barbara Van Der Pol, PhD, a professor of medicine and public health at the University of Alabama at Birmingham and an author of the new study, a meta-analysis of 97 studies published between 1995 and 2021.

Vaginal swabs for chlamydia trachomatis had a diagnostic sensitivity of 94.1% (95% confidence interval, 93.2%-94.9%; P < .001), higher than urine testing (86.9%; 95% CI, 85.6%-88.0%; P < .001). The pooled sensitivity estimates for Neisseria gonorrhoeae were 96.5% (95% CI, 94.8%-97.7%; P < .001) for vaginal swabs and 90.7% (95% CI, 88.4%-92.5%; P < .001) for urine specimens.

The difference in pooled sensitivity estimates between vaginal swabs and urine analyses for Trichomonas vaginalis was 98% (95% CI, 97.0%-98.7%; P < .001) for vaginal swabs and 95.1% (95% CI, 93.6%-96.3%) for urine specimens.

STIs included in the study are not typically found in the urethra and appear in urine analyses only if cervical or vaginal cells have dripped into a urine sample. Dr. Van Der Pol and her colleagues estimated that the use of urine samples rather than vaginal swabs may result in more than 400,000 undiagnosed infections annually.

Undiagnosed and untreated STIs can lead to transmissions of the infection as well as infertility and can have negative effects on romantic relationships, according to Dr. Van Der Pol.

Sarah Wood, MD, an attending physician at Children’s Hospital of Philadelphia, said some health care providers may use urine analysis because patients may be more comfortable with this method. The approach also can be more convenient for medical offices: All they must do is hand a specimen container to the patient.

Conversations between clinicians and patients about vaginal swabbing may be considered “sensitive” and the swabbing more invasive, Dr. Wood, an author of an editorial accompanying the journal article, said. Clinicians may also lack awareness that the swab is a more sensitive method of detecting these STIs.

“We all want to do what’s right for our patient, but we often don’t know what’s right for the patient,” Dr. Wood said. “I don’t think people are really aware of a potential real difference in outcomes with one method over the other.”

Dr. Wood advised making STI screening using vaginal swabs more common by “offering universal opt-out screening, so not waiting until you find out if someone’s having sex but just sort of saying, ‘Hey, across our practice, we screen everybody for chlamydia. Is that something that you want to do today?’ That approach sort of takes out the piece of talking about sex, talking about sexual activity.”

Dr. Van Der Pol, who said she has worked in STI diagnostics for 40 years, said she was not surprised by the results and hopes the study changes how samples are collected and used.

“I really hope that it influences practice so that we really start using vaginal swabs, because it gives us better diagnostics for chlamydia and gonorrhea,” Dr. Van Der Pol said.

“Also, then starting to think about comprehensive women’s care in such a way that they actually order other tests on that same sample if a woman is presenting with complaints.”

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

Vaginal swabs are more effective than urine analysis in detecting certain types of sexually transmitted infections, researchers have found.

In the study, which was published online in the Annals of Family Medicine, investigators found that the diagnostic sensitivity of commercially available vaginal swabs was significantly greater than that of urine tests in detecting certain infections, including those caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Researchers studied chlamydia and gonorrhea, which are two of the most frequently reported STIs in the United States. Trichomoniasis is the most curable nonviral STI globally, with 156 million cases worldwide in 2016.

The Centers for Disease Control and Prevention has long recommended that vaginal swabs be used to produce optimal samples.

But despite the CDC’s recommendation, urine analysis for these STIs is more commonly used than vaginal swabs among U.S. health care providers.

“We’re using a poor sample type, and we can do better,” said Barbara Van Der Pol, PhD, a professor of medicine and public health at the University of Alabama at Birmingham and an author of the new study, a meta-analysis of 97 studies published between 1995 and 2021.

Vaginal swabs for chlamydia trachomatis had a diagnostic sensitivity of 94.1% (95% confidence interval, 93.2%-94.9%; P < .001), higher than urine testing (86.9%; 95% CI, 85.6%-88.0%; P < .001). The pooled sensitivity estimates for Neisseria gonorrhoeae were 96.5% (95% CI, 94.8%-97.7%; P < .001) for vaginal swabs and 90.7% (95% CI, 88.4%-92.5%; P < .001) for urine specimens.

The difference in pooled sensitivity estimates between vaginal swabs and urine analyses for Trichomonas vaginalis was 98% (95% CI, 97.0%-98.7%; P < .001) for vaginal swabs and 95.1% (95% CI, 93.6%-96.3%) for urine specimens.

STIs included in the study are not typically found in the urethra and appear in urine analyses only if cervical or vaginal cells have dripped into a urine sample. Dr. Van Der Pol and her colleagues estimated that the use of urine samples rather than vaginal swabs may result in more than 400,000 undiagnosed infections annually.

Undiagnosed and untreated STIs can lead to transmissions of the infection as well as infertility and can have negative effects on romantic relationships, according to Dr. Van Der Pol.

Sarah Wood, MD, an attending physician at Children’s Hospital of Philadelphia, said some health care providers may use urine analysis because patients may be more comfortable with this method. The approach also can be more convenient for medical offices: All they must do is hand a specimen container to the patient.

Conversations between clinicians and patients about vaginal swabbing may be considered “sensitive” and the swabbing more invasive, Dr. Wood, an author of an editorial accompanying the journal article, said. Clinicians may also lack awareness that the swab is a more sensitive method of detecting these STIs.

“We all want to do what’s right for our patient, but we often don’t know what’s right for the patient,” Dr. Wood said. “I don’t think people are really aware of a potential real difference in outcomes with one method over the other.”

Dr. Wood advised making STI screening using vaginal swabs more common by “offering universal opt-out screening, so not waiting until you find out if someone’s having sex but just sort of saying, ‘Hey, across our practice, we screen everybody for chlamydia. Is that something that you want to do today?’ That approach sort of takes out the piece of talking about sex, talking about sexual activity.”

Dr. Van Der Pol, who said she has worked in STI diagnostics for 40 years, said she was not surprised by the results and hopes the study changes how samples are collected and used.

“I really hope that it influences practice so that we really start using vaginal swabs, because it gives us better diagnostics for chlamydia and gonorrhea,” Dr. Van Der Pol said.

“Also, then starting to think about comprehensive women’s care in such a way that they actually order other tests on that same sample if a woman is presenting with complaints.”

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

The US Preventive Services Task Force (USPSTF) recently published a draft recommendation on the use of folic acid before and during pregnancy to prevent fetal neural tube defects.¹ This reaffirmation of the 2017 recommendation states that all persons planning to or who could become pregnant should take a daily supplement of folic acid.^1,2 This is an “A” recommendation.

Neural tube defects are caused by a failure of the embryonic neural tube to close completely, which should occur in the first 28 days following fertilization. This is why folic acid is most effective if started at least 1 month before conception and continued for the first 2 to 3 months of pregnancy.

An estimated 3000 neural tube defects occur each year in the United States. Spina bifida, anencephaly, and encephalocele occur at respective rates of 3.9, 2.5, and 1.0 in 10,000 live births in the United States, which totals 7.4/10,000.³

Folic acid, if taken before and during pregnancy, can prevent about half of neural tube defects; if taken only during pregnancy, it prevents about one-third. If 50% of neural tube defects could be prevented with folic acid supplements, the number needed to treat (NNT) to prevent 1 case is about 3000.⁴

The case for supplementation. The recommended daily dose of folic acid is between 0.4 mg (400 μg) and 0.8 mg (800 μg), which is contained in many multivitamin products. Certain enriched cereal grain products in the United States have been fortified with folic acid for more than 2 decades, but it is unknown whether women in the United States are ingesting enough of these fortified foods to provide maximum prevention of neural tube defects. There are no known harms to mother or fetus from folic acid supplementation at recommended levels.

Room for improvement. Only 20% to 40% of people who are pregnant or trying to get pregnant, and 5% to 10% of people with an unplanned pregnancy, take folic acid supplements. Half of all pregnancies in the United States are unplanned.⁴ This leaves a lot of room for improvement in the prevention of neural tube defects.

An important recommendation, even if you don’t see the results. The NNT to prevent a case of neural tube defect is high; most family physicians providing perinatal care will not prevent a case during their career. And, as with most preventive interventions, we do not see the cases prevented. However, on a population-wide basis, if all women took folic acid as recommended, the number of severe birth defects prevented would be significant—making this simple recommendation worth mentioning to those of reproductive age.

The US Preventive Services Task Force (USPSTF) recently published a draft recommendation on the use of folic acid before and during pregnancy to prevent fetal neural tube defects.¹ This reaffirmation of the 2017 recommendation states that all persons planning to or who could become pregnant should take a daily supplement of folic acid.^1,2 This is an “A” recommendation.

Neural tube defects are caused by a failure of the embryonic neural tube to close completely, which should occur in the first 28 days following fertilization. This is why folic acid is most effective if started at least 1 month before conception and continued for the first 2 to 3 months of pregnancy.

An estimated 3000 neural tube defects occur each year in the United States. Spina bifida, anencephaly, and encephalocele occur at respective rates of 3.9, 2.5, and 1.0 in 10,000 live births in the United States, which totals 7.4/10,000.³

Folic acid, if taken before and during pregnancy, can prevent about half of neural tube defects; if taken only during pregnancy, it prevents about one-third. If 50% of neural tube defects could be prevented with folic acid supplements, the number needed to treat (NNT) to prevent 1 case is about 3000.⁴

The case for supplementation. The recommended daily dose of folic acid is between 0.4 mg (400 μg) and 0.8 mg (800 μg), which is contained in many multivitamin products. Certain enriched cereal grain products in the United States have been fortified with folic acid for more than 2 decades, but it is unknown whether women in the United States are ingesting enough of these fortified foods to provide maximum prevention of neural tube defects. There are no known harms to mother or fetus from folic acid supplementation at recommended levels.

Room for improvement. Only 20% to 40% of people who are pregnant or trying to get pregnant, and 5% to 10% of people with an unplanned pregnancy, take folic acid supplements. Half of all pregnancies in the United States are unplanned.⁴ This leaves a lot of room for improvement in the prevention of neural tube defects.

An important recommendation, even if you don’t see the results. The NNT to prevent a case of neural tube defect is high; most family physicians providing perinatal care will not prevent a case during their career. And, as with most preventive interventions, we do not see the cases prevented. However, on a population-wide basis, if all women took folic acid as recommended, the number of severe birth defects prevented would be significant—making this simple recommendation worth mentioning to those of reproductive age.

The US Preventive Services Task Force (USPSTF) recently published a draft recommendation on the use of folic acid before and during pregnancy to prevent fetal neural tube defects.¹ This reaffirmation of the 2017 recommendation states that all persons planning to or who could become pregnant should take a daily supplement of folic acid.^1,2 This is an “A” recommendation.

Neural tube defects are caused by a failure of the embryonic neural tube to close completely, which should occur in the first 28 days following fertilization. This is why folic acid is most effective if started at least 1 month before conception and continued for the first 2 to 3 months of pregnancy.

An estimated 3000 neural tube defects occur each year in the United States. Spina bifida, anencephaly, and encephalocele occur at respective rates of 3.9, 2.5, and 1.0 in 10,000 live births in the United States, which totals 7.4/10,000.³

Folic acid, if taken before and during pregnancy, can prevent about half of neural tube defects; if taken only during pregnancy, it prevents about one-third. If 50% of neural tube defects could be prevented with folic acid supplements, the number needed to treat (NNT) to prevent 1 case is about 3000.⁴

The case for supplementation. The recommended daily dose of folic acid is between 0.4 mg (400 μg) and 0.8 mg (800 μg), which is contained in many multivitamin products. Certain enriched cereal grain products in the United States have been fortified with folic acid for more than 2 decades, but it is unknown whether women in the United States are ingesting enough of these fortified foods to provide maximum prevention of neural tube defects. There are no known harms to mother or fetus from folic acid supplementation at recommended levels.

Room for improvement. Only 20% to 40% of people who are pregnant or trying to get pregnant, and 5% to 10% of people with an unplanned pregnancy, take folic acid supplements. Half of all pregnancies in the United States are unplanned.⁴ This leaves a lot of room for improvement in the prevention of neural tube defects.

An important recommendation, even if you don’t see the results. The NNT to prevent a case of neural tube defect is high; most family physicians providing perinatal care will not prevent a case during their career. And, as with most preventive interventions, we do not see the cases prevented. However, on a population-wide basis, if all women took folic acid as recommended, the number of severe birth defects prevented would be significant—making this simple recommendation worth mentioning to those of reproductive age.

California lawmakers are considering legislation to protect California physicians and pharmacists who prescribe abortion pills to out-of-state patients. The proposed law would shield health care providers who are legally performing their jobs in California from facing prosecution in another state or being extradited.

State Sen. Nancy Skinner, who introduced the bill, said the legislation is necessary in a fractured, post-Roe legal landscape where doctors in some states can face felony charges or civil penalties for providing reproductive health care. It’s part of a package of 17 new bills aiming to “strengthen California’s standing as a safe haven for abortion, contraception, and pregnancy care,” according to a press release.

“I’m trying to protect our healthcare practitioners so they can do their jobs, without fear,” Ms. Skinner said in a statement on March 24.

Most abortions are banned in 14 states after the Supreme Court overturned Roe v. Wade. Lawmakers in those states have established a variety of penalties for doctors, pharmacists, and other clinicians to provide abortion care or assist patients in obtaining abortions, including jail time, fines, and loss of professional licenses.

As a result, doctors in restrictive states have anguished over having to delay treatment for patients experiencing miscarriages, ectopic pregnancies, and other conditions until their lives are enough at risk to satisfy exceptions to state abortion laws.

“As a physician, I believe everyone deserves the care they need, regardless of where they live,” said Daniel Grossman, MD, a University of California, San Francisco, ob.gyn. professor who directs the university’s Advancing New Standards in Reproductive Health program.

“Since the fall of Roe v. Wade, patients are being forced to travel long distances – often over 500 miles – to access abortion care in a clinic. People should be able to access this essential care closer to home, including by telemedicine, which has been shown to be safe and effective. I am hopeful that SB 345 will provide additional legal protections that would allow California clinicians to help patients in other states,” he stated.

Other states, including New York, Vermont, New Jersey, Massachusetts, and Connecticut, have passed or are considering similar legislation to protect doctors using telemedicine to prescribe abortion medication to out-of-state patients. These laws come amid a growing push by some states and anti-abortion groups to severely restrict access to abortion pills.

Wyoming is the first state to explicitly ban the pills, although a judge on March 22 blocked that ban. And, in a closely watched case, a conservative federal judge could soon rule to ban sales of mifepristone, one of the medications in a two-pill regimen approved for abortions early in pregnancy.

California’s legislation protects clinicians from losing their California professional licenses if an out-of-state medical board takes action against them. It also allows clinicians to sue anyone who tries to legally interfere with the care they are providing.

It also covers California physicians prescribing contraceptives or gender-affirming care to out-of-state patients. At least 21 states are considering restrictions on gender-affirming care for minors and another 9 states have passed them, according to the advocacy group Human Rights Campaign. Courts have blocked the restrictions in some states.

“It’s understandable that states like California want to reassure their doctors ... that, if one of their patients is caught in one of those states and can’t get help locally, they can step up to help and feel safe in doing so,” said Matthew Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora.

“This is also a crazy development in terms of the law. It’s just one part of the legal mayhem that was predicted when the Supreme Court overturned Roe,” Dr. Wynia said of the growing number of bills protecting in-state doctors. These bills “will almost certainly end up being litigated over issues of interstate commerce, cross-state licensure and practice compacts, FDA regulations and authorities, and maybe more. It’s a huge mess, in which both doctors and patients are being hurt.”

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

California lawmakers are considering legislation to protect California physicians and pharmacists who prescribe abortion pills to out-of-state patients. The proposed law would shield health care providers who are legally performing their jobs in California from facing prosecution in another state or being extradited.

State Sen. Nancy Skinner, who introduced the bill, said the legislation is necessary in a fractured, post-Roe legal landscape where doctors in some states can face felony charges or civil penalties for providing reproductive health care. It’s part of a package of 17 new bills aiming to “strengthen California’s standing as a safe haven for abortion, contraception, and pregnancy care,” according to a press release.

“I’m trying to protect our healthcare practitioners so they can do their jobs, without fear,” Ms. Skinner said in a statement on March 24.

Most abortions are banned in 14 states after the Supreme Court overturned Roe v. Wade. Lawmakers in those states have established a variety of penalties for doctors, pharmacists, and other clinicians to provide abortion care or assist patients in obtaining abortions, including jail time, fines, and loss of professional licenses.

As a result, doctors in restrictive states have anguished over having to delay treatment for patients experiencing miscarriages, ectopic pregnancies, and other conditions until their lives are enough at risk to satisfy exceptions to state abortion laws.

“As a physician, I believe everyone deserves the care they need, regardless of where they live,” said Daniel Grossman, MD, a University of California, San Francisco, ob.gyn. professor who directs the university’s Advancing New Standards in Reproductive Health program.

“Since the fall of Roe v. Wade, patients are being forced to travel long distances – often over 500 miles – to access abortion care in a clinic. People should be able to access this essential care closer to home, including by telemedicine, which has been shown to be safe and effective. I am hopeful that SB 345 will provide additional legal protections that would allow California clinicians to help patients in other states,” he stated.

Other states, including New York, Vermont, New Jersey, Massachusetts, and Connecticut, have passed or are considering similar legislation to protect doctors using telemedicine to prescribe abortion medication to out-of-state patients. These laws come amid a growing push by some states and anti-abortion groups to severely restrict access to abortion pills.

Wyoming is the first state to explicitly ban the pills, although a judge on March 22 blocked that ban. And, in a closely watched case, a conservative federal judge could soon rule to ban sales of mifepristone, one of the medications in a two-pill regimen approved for abortions early in pregnancy.

California’s legislation protects clinicians from losing their California professional licenses if an out-of-state medical board takes action against them. It also allows clinicians to sue anyone who tries to legally interfere with the care they are providing.

It also covers California physicians prescribing contraceptives or gender-affirming care to out-of-state patients. At least 21 states are considering restrictions on gender-affirming care for minors and another 9 states have passed them, according to the advocacy group Human Rights Campaign. Courts have blocked the restrictions in some states.

“It’s understandable that states like California want to reassure their doctors ... that, if one of their patients is caught in one of those states and can’t get help locally, they can step up to help and feel safe in doing so,” said Matthew Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora.

“This is also a crazy development in terms of the law. It’s just one part of the legal mayhem that was predicted when the Supreme Court overturned Roe,” Dr. Wynia said of the growing number of bills protecting in-state doctors. These bills “will almost certainly end up being litigated over issues of interstate commerce, cross-state licensure and practice compacts, FDA regulations and authorities, and maybe more. It’s a huge mess, in which both doctors and patients are being hurt.”

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

California lawmakers are considering legislation to protect California physicians and pharmacists who prescribe abortion pills to out-of-state patients. The proposed law would shield health care providers who are legally performing their jobs in California from facing prosecution in another state or being extradited.

State Sen. Nancy Skinner, who introduced the bill, said the legislation is necessary in a fractured, post-Roe legal landscape where doctors in some states can face felony charges or civil penalties for providing reproductive health care. It’s part of a package of 17 new bills aiming to “strengthen California’s standing as a safe haven for abortion, contraception, and pregnancy care,” according to a press release.

“I’m trying to protect our healthcare practitioners so they can do their jobs, without fear,” Ms. Skinner said in a statement on March 24.

Most abortions are banned in 14 states after the Supreme Court overturned Roe v. Wade. Lawmakers in those states have established a variety of penalties for doctors, pharmacists, and other clinicians to provide abortion care or assist patients in obtaining abortions, including jail time, fines, and loss of professional licenses.

As a result, doctors in restrictive states have anguished over having to delay treatment for patients experiencing miscarriages, ectopic pregnancies, and other conditions until their lives are enough at risk to satisfy exceptions to state abortion laws.

“As a physician, I believe everyone deserves the care they need, regardless of where they live,” said Daniel Grossman, MD, a University of California, San Francisco, ob.gyn. professor who directs the university’s Advancing New Standards in Reproductive Health program.

“Since the fall of Roe v. Wade, patients are being forced to travel long distances – often over 500 miles – to access abortion care in a clinic. People should be able to access this essential care closer to home, including by telemedicine, which has been shown to be safe and effective. I am hopeful that SB 345 will provide additional legal protections that would allow California clinicians to help patients in other states,” he stated.

Other states, including New York, Vermont, New Jersey, Massachusetts, and Connecticut, have passed or are considering similar legislation to protect doctors using telemedicine to prescribe abortion medication to out-of-state patients. These laws come amid a growing push by some states and anti-abortion groups to severely restrict access to abortion pills.

Wyoming is the first state to explicitly ban the pills, although a judge on March 22 blocked that ban. And, in a closely watched case, a conservative federal judge could soon rule to ban sales of mifepristone, one of the medications in a two-pill regimen approved for abortions early in pregnancy.

California’s legislation protects clinicians from losing their California professional licenses if an out-of-state medical board takes action against them. It also allows clinicians to sue anyone who tries to legally interfere with the care they are providing.

It also covers California physicians prescribing contraceptives or gender-affirming care to out-of-state patients. At least 21 states are considering restrictions on gender-affirming care for minors and another 9 states have passed them, according to the advocacy group Human Rights Campaign. Courts have blocked the restrictions in some states.

“It’s understandable that states like California want to reassure their doctors ... that, if one of their patients is caught in one of those states and can’t get help locally, they can step up to help and feel safe in doing so,” said Matthew Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora.

“This is also a crazy development in terms of the law. It’s just one part of the legal mayhem that was predicted when the Supreme Court overturned Roe,” Dr. Wynia said of the growing number of bills protecting in-state doctors. These bills “will almost certainly end up being litigated over issues of interstate commerce, cross-state licensure and practice compacts, FDA regulations and authorities, and maybe more. It’s a huge mess, in which both doctors and patients are being hurt.”

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

Among patients who undergo forceps-assisted vaginal delivery, obesity does not appear to be associated with increased risk for complications such as injuries to the anal sphincter or the need for their babies to be admitted to the neonatal intensive care unit, researchers have found.

But obesity does appear to increase the chances that when physicians attempt operative vaginal delivery with either forceps or a vacuum, patients will wind up undergoing cesarean delivery, another study found.

Taken together, the new data may help inform physicians’ decisions about when to consider operative vaginal delivery as an alternative to emergency cesarean births.

A prospective study showed that failed operative vaginal delivery – that is, a cesarean delivery after an attempted operative vaginal delivery – occurred for 10.1% of patients with obesity and 4.2% of those without obesity.

Researchers presented the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“We want to really try to reduce the rate of C-sections and primary cesarean deliveries. One of the ways to do that is to attempt operative vaginal delivery,” said Marissa Platner, MD, assistant professor of maternal-fetal medicine at Emory University School of Medicine, Atlanta, who was not involved in the new research.

Data on how obesity influences risks with operative vaginal delivery have been limited and mixed, the researchers said.

To examine how often attempted operative vaginal delivery fails in patients with obesity, Jennifer Grasch, MD, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus, and her colleagues conducted a secondary analysis of data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which included more than 10,000 participants.

“We know that cesarean sections among people with obesity are associated with increased complications, such as higher rates of infection and wound complications, than for people with lower BMI,” Dr. Grasch said. “Operative vaginal delivery can be an alternative to cesarean delivery in some situations, so we were interested in whether attempted operative vaginal delivery was also associated with higher rates of complications in individuals with obesity than those without obesity.”

The researchers focused on 791 patients with an attempted operative vaginal delivery. About 40% had a BMI of 30 or greater. Clinicians used a vacuum in approximately 60% of the attempts.

After an attempted vacuum-assisted delivery, neonatal morbidity was more common for infants whose mothers had obesity than for those whose mothers did not (32.7% vs. 22.3%; adjusted odds ratio, 1.61 [1.07-2.43]). Neonatal morbidity did not differ by obesity status following forceps-attempted delivery. Other adverse outcomes, including measures of maternal morbidity, did not significantly differ by obesity status, according to the researchers.
 

Choice may come down to experience

Several factors influence whether a clinician chooses forceps- or vacuum-assisted delivery or cesarean delivery, “but one of the most important is experience,” Dr. Grasch said. “Complication rates with both forms of operative vaginal delivery are low, yet there has been a trend toward lower rates of both in the last few decades.”

Elizabeth Cochrane, MD, a maternal-fetal medicine fellow at Mount Sinai Hospital, New York, and her colleagues investigated the relationship between obesity and adverse outcomes among patients with forceps-assisted vaginal deliveries.

The researchers analyzed data from 897 patients who underwent a forceps-assisted vaginal delivery between 2017 and 2021; 29% had a BMI of 30 or greater.

Injuries to the anal sphincter – which can lead to fecal incontinence – occurred in 18.7% of patients without obesity and in 17.7% of those with obesity. Admission to the neonatal intensive care unit occurred in 11.5% of patients without obesity and in 12.3% of patients with obesity. The differences were not statistically significant.

The bottom line: For forceps-assisted vaginal delivery, “obesity does not appear to be associated with increased rates” of adverse outcomes for mothers or newborns, the researchers concluded.
 

Reassuring data

The study by Dr. Cochrane’s group “provides helpful information for providers to be reassured when they are performing forceps deliveries” for patients with obesity, Dr. Platner said.

Rates of obesity have risen in the United States, and physicians often wonder whether a patient with obesity could be a candidate for forceps-assisted delivery, Dr. Cochrane said. In 2019, 29% of women had obesity before becoming pregnant.

“It all really comes down to how comfortable the provider is in that skill set and also the overall clinical scenario,” she said. “Sometimes an operative delivery with forceps or a vacuum can be the fastest way to deliver a baby when there is acute concern for maternal decompensation or fetal decompensation.”

The alternative is an emergency cesarean delivery. Given that those operations can be riskier and more difficult for patients with higher BMIs, a forceps-assisted delivery may be “an interesting alternative to emergency caesarean sections, as long as it is in an appropriate clinical setting with providers who feel very confident and comfortable using those devices,” Dr. Cochrane said.

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

Among patients who undergo forceps-assisted vaginal delivery, obesity does not appear to be associated with increased risk for complications such as injuries to the anal sphincter or the need for their babies to be admitted to the neonatal intensive care unit, researchers have found.

But obesity does appear to increase the chances that when physicians attempt operative vaginal delivery with either forceps or a vacuum, patients will wind up undergoing cesarean delivery, another study found.

Taken together, the new data may help inform physicians’ decisions about when to consider operative vaginal delivery as an alternative to emergency cesarean births.

A prospective study showed that failed operative vaginal delivery – that is, a cesarean delivery after an attempted operative vaginal delivery – occurred for 10.1% of patients with obesity and 4.2% of those without obesity.

Researchers presented the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“We want to really try to reduce the rate of C-sections and primary cesarean deliveries. One of the ways to do that is to attempt operative vaginal delivery,” said Marissa Platner, MD, assistant professor of maternal-fetal medicine at Emory University School of Medicine, Atlanta, who was not involved in the new research.

Data on how obesity influences risks with operative vaginal delivery have been limited and mixed, the researchers said.

To examine how often attempted operative vaginal delivery fails in patients with obesity, Jennifer Grasch, MD, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus, and her colleagues conducted a secondary analysis of data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which included more than 10,000 participants.

“We know that cesarean sections among people with obesity are associated with increased complications, such as higher rates of infection and wound complications, than for people with lower BMI,” Dr. Grasch said. “Operative vaginal delivery can be an alternative to cesarean delivery in some situations, so we were interested in whether attempted operative vaginal delivery was also associated with higher rates of complications in individuals with obesity than those without obesity.”

The researchers focused on 791 patients with an attempted operative vaginal delivery. About 40% had a BMI of 30 or greater. Clinicians used a vacuum in approximately 60% of the attempts.

After an attempted vacuum-assisted delivery, neonatal morbidity was more common for infants whose mothers had obesity than for those whose mothers did not (32.7% vs. 22.3%; adjusted odds ratio, 1.61 [1.07-2.43]). Neonatal morbidity did not differ by obesity status following forceps-attempted delivery. Other adverse outcomes, including measures of maternal morbidity, did not significantly differ by obesity status, according to the researchers.
 

Choice may come down to experience

Several factors influence whether a clinician chooses forceps- or vacuum-assisted delivery or cesarean delivery, “but one of the most important is experience,” Dr. Grasch said. “Complication rates with both forms of operative vaginal delivery are low, yet there has been a trend toward lower rates of both in the last few decades.”

Elizabeth Cochrane, MD, a maternal-fetal medicine fellow at Mount Sinai Hospital, New York, and her colleagues investigated the relationship between obesity and adverse outcomes among patients with forceps-assisted vaginal deliveries.

The researchers analyzed data from 897 patients who underwent a forceps-assisted vaginal delivery between 2017 and 2021; 29% had a BMI of 30 or greater.

Injuries to the anal sphincter – which can lead to fecal incontinence – occurred in 18.7% of patients without obesity and in 17.7% of those with obesity. Admission to the neonatal intensive care unit occurred in 11.5% of patients without obesity and in 12.3% of patients with obesity. The differences were not statistically significant.

The bottom line: For forceps-assisted vaginal delivery, “obesity does not appear to be associated with increased rates” of adverse outcomes for mothers or newborns, the researchers concluded.
 

Reassuring data

The study by Dr. Cochrane’s group “provides helpful information for providers to be reassured when they are performing forceps deliveries” for patients with obesity, Dr. Platner said.

Rates of obesity have risen in the United States, and physicians often wonder whether a patient with obesity could be a candidate for forceps-assisted delivery, Dr. Cochrane said. In 2019, 29% of women had obesity before becoming pregnant.

“It all really comes down to how comfortable the provider is in that skill set and also the overall clinical scenario,” she said. “Sometimes an operative delivery with forceps or a vacuum can be the fastest way to deliver a baby when there is acute concern for maternal decompensation or fetal decompensation.”

The alternative is an emergency cesarean delivery. Given that those operations can be riskier and more difficult for patients with higher BMIs, a forceps-assisted delivery may be “an interesting alternative to emergency caesarean sections, as long as it is in an appropriate clinical setting with providers who feel very confident and comfortable using those devices,” Dr. Cochrane said.

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

Among patients who undergo forceps-assisted vaginal delivery, obesity does not appear to be associated with increased risk for complications such as injuries to the anal sphincter or the need for their babies to be admitted to the neonatal intensive care unit, researchers have found.

But obesity does appear to increase the chances that when physicians attempt operative vaginal delivery with either forceps or a vacuum, patients will wind up undergoing cesarean delivery, another study found.

Taken together, the new data may help inform physicians’ decisions about when to consider operative vaginal delivery as an alternative to emergency cesarean births.

A prospective study showed that failed operative vaginal delivery – that is, a cesarean delivery after an attempted operative vaginal delivery – occurred for 10.1% of patients with obesity and 4.2% of those without obesity.

Researchers presented the findings at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“We want to really try to reduce the rate of C-sections and primary cesarean deliveries. One of the ways to do that is to attempt operative vaginal delivery,” said Marissa Platner, MD, assistant professor of maternal-fetal medicine at Emory University School of Medicine, Atlanta, who was not involved in the new research.

Data on how obesity influences risks with operative vaginal delivery have been limited and mixed, the researchers said.

To examine how often attempted operative vaginal delivery fails in patients with obesity, Jennifer Grasch, MD, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus, and her colleagues conducted a secondary analysis of data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, which included more than 10,000 participants.

“We know that cesarean sections among people with obesity are associated with increased complications, such as higher rates of infection and wound complications, than for people with lower BMI,” Dr. Grasch said. “Operative vaginal delivery can be an alternative to cesarean delivery in some situations, so we were interested in whether attempted operative vaginal delivery was also associated with higher rates of complications in individuals with obesity than those without obesity.”

The researchers focused on 791 patients with an attempted operative vaginal delivery. About 40% had a BMI of 30 or greater. Clinicians used a vacuum in approximately 60% of the attempts.

After an attempted vacuum-assisted delivery, neonatal morbidity was more common for infants whose mothers had obesity than for those whose mothers did not (32.7% vs. 22.3%; adjusted odds ratio, 1.61 [1.07-2.43]). Neonatal morbidity did not differ by obesity status following forceps-attempted delivery. Other adverse outcomes, including measures of maternal morbidity, did not significantly differ by obesity status, according to the researchers.
 

Choice may come down to experience

Several factors influence whether a clinician chooses forceps- or vacuum-assisted delivery or cesarean delivery, “but one of the most important is experience,” Dr. Grasch said. “Complication rates with both forms of operative vaginal delivery are low, yet there has been a trend toward lower rates of both in the last few decades.”

Elizabeth Cochrane, MD, a maternal-fetal medicine fellow at Mount Sinai Hospital, New York, and her colleagues investigated the relationship between obesity and adverse outcomes among patients with forceps-assisted vaginal deliveries.

The researchers analyzed data from 897 patients who underwent a forceps-assisted vaginal delivery between 2017 and 2021; 29% had a BMI of 30 or greater.

Injuries to the anal sphincter – which can lead to fecal incontinence – occurred in 18.7% of patients without obesity and in 17.7% of those with obesity. Admission to the neonatal intensive care unit occurred in 11.5% of patients without obesity and in 12.3% of patients with obesity. The differences were not statistically significant.

The bottom line: For forceps-assisted vaginal delivery, “obesity does not appear to be associated with increased rates” of adverse outcomes for mothers or newborns, the researchers concluded.
 

Reassuring data

The study by Dr. Cochrane’s group “provides helpful information for providers to be reassured when they are performing forceps deliveries” for patients with obesity, Dr. Platner said.

Rates of obesity have risen in the United States, and physicians often wonder whether a patient with obesity could be a candidate for forceps-assisted delivery, Dr. Cochrane said. In 2019, 29% of women had obesity before becoming pregnant.

“It all really comes down to how comfortable the provider is in that skill set and also the overall clinical scenario,” she said. “Sometimes an operative delivery with forceps or a vacuum can be the fastest way to deliver a baby when there is acute concern for maternal decompensation or fetal decompensation.”

The alternative is an emergency cesarean delivery. Given that those operations can be riskier and more difficult for patients with higher BMIs, a forceps-assisted delivery may be “an interesting alternative to emergency caesarean sections, as long as it is in an appropriate clinical setting with providers who feel very confident and comfortable using those devices,” Dr. Cochrane said.

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

Long-term osteoporosis medications are associated with a reduced mortality risk following a fracture, new data suggest.

The findings, from nearly 50,000 individuals in a nationwide Taiwanese database from 2009 until 2018, suggest that alendronate/risedronate, denosumab, and zoledronic acid all result in a significantly lower mortality risk post fracture of 17%-22%, compared with raloxifene and bazedoxifene.

“Treatment for osteoporosis has the potential to minimize mortality risk in people of all ages and sexes for any type of fracture. The longer-acting treatments could lower mortality risk,” wrote Chih-Hsing Wu, MD, of the Institute of Gerontology at National Cheng Kung University, Tainan, Taiwan, and colleagues.

The findings have been published online in the Journal of Clinical Endocrinology and Metabolism.

Robert A. Adler, MD, who is chief of endocrinology at the Central Virginia Veterans Affairs Health Care System, Richmond, told this news organization that he hopes these new findings from a “really good database ... may be helpful in talking to a patient about the pros and cons of taking these drugs.”

“Patients have been made very fearful of the unusual side effects, particularly of the antiresorptive drugs,” which he notes include the rare adverse effects of jaw necrosis and atypical femoral fracture, which occur in about 1 per 10,000 patient-years.

“And because of that we have a hard time convincing people to want to take the drug in the first place or to stay on the drug once they start,” said Dr. Adler, who stressed that his viewpoints are his own and not representative of the VA.

“These data should help reinforce the advice already given in professional guidelines that their benefit outweighs any risks,” he stresses.

Dr. Adler also pointed out that both bisphosphonates included in the study, alendronate and zoledronic acid, are now available as generics and therefore inexpensive, but the latter can be subject to facility fees depending on where the infusion is delivered.

He added that hip fracture, in particular, triples the overall 1-year mortality risk in women aged 75-84 years and quadruples the risk in men. The study’s findings suggest that bisphosphonates, in particular, have pleiotropic effects beyond the bone; however, the underlying mechanisms are hard to determine.

“We don’t know all the reasons why people die after a fracture. These are older people who often have multiple medical problems, so it’s hard to dissect that out,” he said.

But whatever the mechanism for the salutary effect of the drugs, Dr. Adler said: “This is one other factor that might change people’s minds. You’re less likely to die. Well, that’s pretty good.”
 

‘Denosumab is a more potent antiresorptive than bisphosphonates’

Dr. Wu and colleagues analyzed data for individuals from Taiwan’s National Health Insurance Research Database. Between 2009 and 2017, 219,461 individuals had been newly diagnosed with an osteoporotic fracture. Of those, 46,729 were aged 40 and older and had been prescribed at least one anti-osteoporosis medication.

Participants were a mean age of 74.5 years, were 80% women, and 32% died during a mean follow-up of 4.7 years. The most commonly used anti-osteoporosis medications were the bisphosphonates alendronate or risedronate, followed by denosumab and the selective estrogen-receptor modulators (SERMs) daily oral raloxifene or bazedoxifene.

Patients treated with SERMs were used as the reference group because those drugs have been shown to have a neutral effect on mortality.

After adjustments, all but one of the medications had significantly lower mortality risks during follow-up, compared with raloxifene and bazedoxifene.

Compared with SERMs, at all fracture sites, the hazard ratios for mortality were 0.83 for alendronate/risedronate, 0.86 for denosumab, and 0.78 for zoledronic acid. Only ibandronate did not show the same protective effect.

Similar results were found for hip and vertebral fractures analyzed individually.  

Women had a lower mortality risk than men.

Dr. Adler wrote an accompanying editorial for the article by Dr. Wu and colleagues.

Regarding the finding of benefit for denosumab, Dr. Adler notes: “I don’t know of another study that found denosumab leads to lower mortality. On the other hand, denosumab is a more potent antiresorptive than bisphosphonates.”

The study was funded by research grants from the Ministry of Science and Technology, Taiwan, partially supported by a research grant from the Taiwanese Osteoporosis Association and grants from National Cheng Kung University Hospital, Taiwan. Dr. Wu has reported receiving honoraria for lectures, attending meetings, and/or travel from Eli Lilly, Roche, Amgen, Merck, Servier, GE Lunar, Harvester, TCM Biotech, and Alvogen/Lotus. Dr. Adler has reported no relevant financial relationships.

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

Long-term osteoporosis medications are associated with a reduced mortality risk following a fracture, new data suggest.

The findings, from nearly 50,000 individuals in a nationwide Taiwanese database from 2009 until 2018, suggest that alendronate/risedronate, denosumab, and zoledronic acid all result in a significantly lower mortality risk post fracture of 17%-22%, compared with raloxifene and bazedoxifene.

“Treatment for osteoporosis has the potential to minimize mortality risk in people of all ages and sexes for any type of fracture. The longer-acting treatments could lower mortality risk,” wrote Chih-Hsing Wu, MD, of the Institute of Gerontology at National Cheng Kung University, Tainan, Taiwan, and colleagues.

The findings have been published online in the Journal of Clinical Endocrinology and Metabolism.

Robert A. Adler, MD, who is chief of endocrinology at the Central Virginia Veterans Affairs Health Care System, Richmond, told this news organization that he hopes these new findings from a “really good database ... may be helpful in talking to a patient about the pros and cons of taking these drugs.”

“Patients have been made very fearful of the unusual side effects, particularly of the antiresorptive drugs,” which he notes include the rare adverse effects of jaw necrosis and atypical femoral fracture, which occur in about 1 per 10,000 patient-years.

“And because of that we have a hard time convincing people to want to take the drug in the first place or to stay on the drug once they start,” said Dr. Adler, who stressed that his viewpoints are his own and not representative of the VA.

“These data should help reinforce the advice already given in professional guidelines that their benefit outweighs any risks,” he stresses.

Dr. Adler also pointed out that both bisphosphonates included in the study, alendronate and zoledronic acid, are now available as generics and therefore inexpensive, but the latter can be subject to facility fees depending on where the infusion is delivered.

He added that hip fracture, in particular, triples the overall 1-year mortality risk in women aged 75-84 years and quadruples the risk in men. The study’s findings suggest that bisphosphonates, in particular, have pleiotropic effects beyond the bone; however, the underlying mechanisms are hard to determine.

“We don’t know all the reasons why people die after a fracture. These are older people who often have multiple medical problems, so it’s hard to dissect that out,” he said.

But whatever the mechanism for the salutary effect of the drugs, Dr. Adler said: “This is one other factor that might change people’s minds. You’re less likely to die. Well, that’s pretty good.”
 

‘Denosumab is a more potent antiresorptive than bisphosphonates’

Dr. Wu and colleagues analyzed data for individuals from Taiwan’s National Health Insurance Research Database. Between 2009 and 2017, 219,461 individuals had been newly diagnosed with an osteoporotic fracture. Of those, 46,729 were aged 40 and older and had been prescribed at least one anti-osteoporosis medication.

Participants were a mean age of 74.5 years, were 80% women, and 32% died during a mean follow-up of 4.7 years. The most commonly used anti-osteoporosis medications were the bisphosphonates alendronate or risedronate, followed by denosumab and the selective estrogen-receptor modulators (SERMs) daily oral raloxifene or bazedoxifene.

Patients treated with SERMs were used as the reference group because those drugs have been shown to have a neutral effect on mortality.

After adjustments, all but one of the medications had significantly lower mortality risks during follow-up, compared with raloxifene and bazedoxifene.

Compared with SERMs, at all fracture sites, the hazard ratios for mortality were 0.83 for alendronate/risedronate, 0.86 for denosumab, and 0.78 for zoledronic acid. Only ibandronate did not show the same protective effect.

Similar results were found for hip and vertebral fractures analyzed individually.  

Women had a lower mortality risk than men.

Dr. Adler wrote an accompanying editorial for the article by Dr. Wu and colleagues.

Regarding the finding of benefit for denosumab, Dr. Adler notes: “I don’t know of another study that found denosumab leads to lower mortality. On the other hand, denosumab is a more potent antiresorptive than bisphosphonates.”

The study was funded by research grants from the Ministry of Science and Technology, Taiwan, partially supported by a research grant from the Taiwanese Osteoporosis Association and grants from National Cheng Kung University Hospital, Taiwan. Dr. Wu has reported receiving honoraria for lectures, attending meetings, and/or travel from Eli Lilly, Roche, Amgen, Merck, Servier, GE Lunar, Harvester, TCM Biotech, and Alvogen/Lotus. Dr. Adler has reported no relevant financial relationships.

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

Long-term osteoporosis medications are associated with a reduced mortality risk following a fracture, new data suggest.

The findings, from nearly 50,000 individuals in a nationwide Taiwanese database from 2009 until 2018, suggest that alendronate/risedronate, denosumab, and zoledronic acid all result in a significantly lower mortality risk post fracture of 17%-22%, compared with raloxifene and bazedoxifene.

“Treatment for osteoporosis has the potential to minimize mortality risk in people of all ages and sexes for any type of fracture. The longer-acting treatments could lower mortality risk,” wrote Chih-Hsing Wu, MD, of the Institute of Gerontology at National Cheng Kung University, Tainan, Taiwan, and colleagues.

The findings have been published online in the Journal of Clinical Endocrinology and Metabolism.

Robert A. Adler, MD, who is chief of endocrinology at the Central Virginia Veterans Affairs Health Care System, Richmond, told this news organization that he hopes these new findings from a “really good database ... may be helpful in talking to a patient about the pros and cons of taking these drugs.”

“Patients have been made very fearful of the unusual side effects, particularly of the antiresorptive drugs,” which he notes include the rare adverse effects of jaw necrosis and atypical femoral fracture, which occur in about 1 per 10,000 patient-years.

“And because of that we have a hard time convincing people to want to take the drug in the first place or to stay on the drug once they start,” said Dr. Adler, who stressed that his viewpoints are his own and not representative of the VA.

“These data should help reinforce the advice already given in professional guidelines that their benefit outweighs any risks,” he stresses.

Dr. Adler also pointed out that both bisphosphonates included in the study, alendronate and zoledronic acid, are now available as generics and therefore inexpensive, but the latter can be subject to facility fees depending on where the infusion is delivered.

He added that hip fracture, in particular, triples the overall 1-year mortality risk in women aged 75-84 years and quadruples the risk in men. The study’s findings suggest that bisphosphonates, in particular, have pleiotropic effects beyond the bone; however, the underlying mechanisms are hard to determine.

“We don’t know all the reasons why people die after a fracture. These are older people who often have multiple medical problems, so it’s hard to dissect that out,” he said.

But whatever the mechanism for the salutary effect of the drugs, Dr. Adler said: “This is one other factor that might change people’s minds. You’re less likely to die. Well, that’s pretty good.”
 

‘Denosumab is a more potent antiresorptive than bisphosphonates’

Dr. Wu and colleagues analyzed data for individuals from Taiwan’s National Health Insurance Research Database. Between 2009 and 2017, 219,461 individuals had been newly diagnosed with an osteoporotic fracture. Of those, 46,729 were aged 40 and older and had been prescribed at least one anti-osteoporosis medication.

Participants were a mean age of 74.5 years, were 80% women, and 32% died during a mean follow-up of 4.7 years. The most commonly used anti-osteoporosis medications were the bisphosphonates alendronate or risedronate, followed by denosumab and the selective estrogen-receptor modulators (SERMs) daily oral raloxifene or bazedoxifene.

Patients treated with SERMs were used as the reference group because those drugs have been shown to have a neutral effect on mortality.

After adjustments, all but one of the medications had significantly lower mortality risks during follow-up, compared with raloxifene and bazedoxifene.

Compared with SERMs, at all fracture sites, the hazard ratios for mortality were 0.83 for alendronate/risedronate, 0.86 for denosumab, and 0.78 for zoledronic acid. Only ibandronate did not show the same protective effect.

Similar results were found for hip and vertebral fractures analyzed individually.  

Women had a lower mortality risk than men.

Dr. Adler wrote an accompanying editorial for the article by Dr. Wu and colleagues.

Regarding the finding of benefit for denosumab, Dr. Adler notes: “I don’t know of another study that found denosumab leads to lower mortality. On the other hand, denosumab is a more potent antiresorptive than bisphosphonates.”

The study was funded by research grants from the Ministry of Science and Technology, Taiwan, partially supported by a research grant from the Taiwanese Osteoporosis Association and grants from National Cheng Kung University Hospital, Taiwan. Dr. Wu has reported receiving honoraria for lectures, attending meetings, and/or travel from Eli Lilly, Roche, Amgen, Merck, Servier, GE Lunar, Harvester, TCM Biotech, and Alvogen/Lotus. Dr. Adler has reported no relevant financial relationships.

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

For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large U.S. trial.

The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.

The study was published by JAMA Network Open.

“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in U.S. health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, department of epidemiology, University of Washington, Seattle.

They note that their results are consistent with those from previous studies in other health care contexts, but their analysis “benefited from the randomized clinical trial design and a large sample size,” they write.

However, they point out that the trial was conducted “before the beginning of the COVID-19 pandemic,” and it is “well established” that cancer screening rates “decreased substantially during the pandemic.”

They suggest that mailed HPV self-sampling kits could nevertheless be a “means of overcoming screening barriers among underscreened women,” which may have been exacerbated by the “societal consequences of the pandemic.”


 

Reducing barriers to screening

Cervical screening is associated with “substantial global reductions” in the incidence and mortality of cervical cancer, the authors point out. Because most cases of the disease are consequently preventable, it now occurs “predominantly in individuals who have never or rarely received screening.”

Home-based HPV-only testing reduces the need for office visits and reduces barriers to screening, such as discomfort, embarrassment, and difficulties with scheduling or attending appointments.

Previous studies have shown that the direct mailing of home-based HPV self-collection kits is associated with increased uptake of screening among underscreened women and is cost-effective, although the researchers point out that these previous studies were conducted in countries with “organized national screening programs.”

For their own study, they focused on home-based HPV screening among underscreened individuals in the United States. The team examined data from the Home-based Options to Make cervical cancer screening Easy trial, which has previously showed that mailing kits to women increased screening uptake, compared with usual care alone.

For the current analysis, they conducted an economic evaluation of data on 19,851 trial participants, who were randomized to receive home-based screening or usual care between February 2014 and August 2016 and were followed up to February 2018.

All of the women were aged 30-64 years and had been enrolled in a health plan from Kaiser Permanente Washington (KPW) for at least 3 years and 5 months. They were also required not have undergone a hysterectomy.

Participant-level economic data were collected between June 2019 and March 2021, with intervention delivery costs calculated from the perspective of both the KPW and Medicare health systems and based on the cost of either a wellness visit or Papanicolaou (Pap) test–only visit.

The mean age of the participants was 50.1 years, and the majority (76.7%) were White; 9.7% were Asian and 4.7% were Black or African American.

There were no significant differences in baseline characteristics between the group assigned to usual care, which comprised patient reminders and ad hoc screening outreach, and those in the intervention group, who received usual care and a mailed HPV self-sampling kit.

The researchers report that 1,206 women in the intervention group sent back a mailed HPV kit, with 1,178 (97.7%) meeting the criteria for completed screening uptake.

Overall, screening uptake was higher in the intervention group than in control participants, at 26.3% vs. 17.4%, respectively (relative risk, 1.51).

Intervention participants were also more likely than controls to have a positive test result (relative risk, 1.49) and to receive treatment (relative risk, 1.70).

The incremental cost-effectiveness ratio for increased screening uptake, defined as the incremental difference in cost between the study groups divided by the difference in the number of participants completing screening within 6 months, ranged from $85.84 per additional completed screening to $146.29, depending on the health system and test considered.

In terms of willingness-to-pay (WTP) thresholds for each additional completed screening, the team found that home-based screening achieved a 90% probability of cost-effectiveness, at a WTP of just $148 if the participant’s last Pap test was between 3.4 and 5.0 years before randomization.

A 90% probability of cost-effectiveness was also achieved at a WTP of $198 among participants aged 50-64 years, a threshold that was lower than that among other age groups.

At a WTP threshold of over $350, the intervention was considered to have 100% probability of being cost-effective in all age groups.

The study was supported by a grant from the National Cancer Institute of the National Institutes of Health. Dr. Winer reports a relationship with the National Cancer Institute outside of the submitted work, as do several other authors.

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

For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large U.S. trial.

The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.

The study was published by JAMA Network Open.

“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in U.S. health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, department of epidemiology, University of Washington, Seattle.

They note that their results are consistent with those from previous studies in other health care contexts, but their analysis “benefited from the randomized clinical trial design and a large sample size,” they write.

However, they point out that the trial was conducted “before the beginning of the COVID-19 pandemic,” and it is “well established” that cancer screening rates “decreased substantially during the pandemic.”

They suggest that mailed HPV self-sampling kits could nevertheless be a “means of overcoming screening barriers among underscreened women,” which may have been exacerbated by the “societal consequences of the pandemic.”


 

Reducing barriers to screening

Cervical screening is associated with “substantial global reductions” in the incidence and mortality of cervical cancer, the authors point out. Because most cases of the disease are consequently preventable, it now occurs “predominantly in individuals who have never or rarely received screening.”

Home-based HPV-only testing reduces the need for office visits and reduces barriers to screening, such as discomfort, embarrassment, and difficulties with scheduling or attending appointments.

Previous studies have shown that the direct mailing of home-based HPV self-collection kits is associated with increased uptake of screening among underscreened women and is cost-effective, although the researchers point out that these previous studies were conducted in countries with “organized national screening programs.”

For their own study, they focused on home-based HPV screening among underscreened individuals in the United States. The team examined data from the Home-based Options to Make cervical cancer screening Easy trial, which has previously showed that mailing kits to women increased screening uptake, compared with usual care alone.

For the current analysis, they conducted an economic evaluation of data on 19,851 trial participants, who were randomized to receive home-based screening or usual care between February 2014 and August 2016 and were followed up to February 2018.

All of the women were aged 30-64 years and had been enrolled in a health plan from Kaiser Permanente Washington (KPW) for at least 3 years and 5 months. They were also required not have undergone a hysterectomy.

Participant-level economic data were collected between June 2019 and March 2021, with intervention delivery costs calculated from the perspective of both the KPW and Medicare health systems and based on the cost of either a wellness visit or Papanicolaou (Pap) test–only visit.

The mean age of the participants was 50.1 years, and the majority (76.7%) were White; 9.7% were Asian and 4.7% were Black or African American.

There were no significant differences in baseline characteristics between the group assigned to usual care, which comprised patient reminders and ad hoc screening outreach, and those in the intervention group, who received usual care and a mailed HPV self-sampling kit.

The researchers report that 1,206 women in the intervention group sent back a mailed HPV kit, with 1,178 (97.7%) meeting the criteria for completed screening uptake.

Overall, screening uptake was higher in the intervention group than in control participants, at 26.3% vs. 17.4%, respectively (relative risk, 1.51).

Intervention participants were also more likely than controls to have a positive test result (relative risk, 1.49) and to receive treatment (relative risk, 1.70).

The incremental cost-effectiveness ratio for increased screening uptake, defined as the incremental difference in cost between the study groups divided by the difference in the number of participants completing screening within 6 months, ranged from $85.84 per additional completed screening to $146.29, depending on the health system and test considered.

In terms of willingness-to-pay (WTP) thresholds for each additional completed screening, the team found that home-based screening achieved a 90% probability of cost-effectiveness, at a WTP of just $148 if the participant’s last Pap test was between 3.4 and 5.0 years before randomization.

A 90% probability of cost-effectiveness was also achieved at a WTP of $198 among participants aged 50-64 years, a threshold that was lower than that among other age groups.

At a WTP threshold of over $350, the intervention was considered to have 100% probability of being cost-effective in all age groups.

The study was supported by a grant from the National Cancer Institute of the National Institutes of Health. Dr. Winer reports a relationship with the National Cancer Institute outside of the submitted work, as do several other authors.

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

For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large U.S. trial.

The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.

The study was published by JAMA Network Open.

“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in U.S. health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, department of epidemiology, University of Washington, Seattle.

They note that their results are consistent with those from previous studies in other health care contexts, but their analysis “benefited from the randomized clinical trial design and a large sample size,” they write.

However, they point out that the trial was conducted “before the beginning of the COVID-19 pandemic,” and it is “well established” that cancer screening rates “decreased substantially during the pandemic.”

They suggest that mailed HPV self-sampling kits could nevertheless be a “means of overcoming screening barriers among underscreened women,” which may have been exacerbated by the “societal consequences of the pandemic.”


 

Reducing barriers to screening

Cervical screening is associated with “substantial global reductions” in the incidence and mortality of cervical cancer, the authors point out. Because most cases of the disease are consequently preventable, it now occurs “predominantly in individuals who have never or rarely received screening.”

Home-based HPV-only testing reduces the need for office visits and reduces barriers to screening, such as discomfort, embarrassment, and difficulties with scheduling or attending appointments.

Previous studies have shown that the direct mailing of home-based HPV self-collection kits is associated with increased uptake of screening among underscreened women and is cost-effective, although the researchers point out that these previous studies were conducted in countries with “organized national screening programs.”

For their own study, they focused on home-based HPV screening among underscreened individuals in the United States. The team examined data from the Home-based Options to Make cervical cancer screening Easy trial, which has previously showed that mailing kits to women increased screening uptake, compared with usual care alone.

For the current analysis, they conducted an economic evaluation of data on 19,851 trial participants, who were randomized to receive home-based screening or usual care between February 2014 and August 2016 and were followed up to February 2018.

All of the women were aged 30-64 years and had been enrolled in a health plan from Kaiser Permanente Washington (KPW) for at least 3 years and 5 months. They were also required not have undergone a hysterectomy.

Participant-level economic data were collected between June 2019 and March 2021, with intervention delivery costs calculated from the perspective of both the KPW and Medicare health systems and based on the cost of either a wellness visit or Papanicolaou (Pap) test–only visit.

The mean age of the participants was 50.1 years, and the majority (76.7%) were White; 9.7% were Asian and 4.7% were Black or African American.

There were no significant differences in baseline characteristics between the group assigned to usual care, which comprised patient reminders and ad hoc screening outreach, and those in the intervention group, who received usual care and a mailed HPV self-sampling kit.

The researchers report that 1,206 women in the intervention group sent back a mailed HPV kit, with 1,178 (97.7%) meeting the criteria for completed screening uptake.

Overall, screening uptake was higher in the intervention group than in control participants, at 26.3% vs. 17.4%, respectively (relative risk, 1.51).

Intervention participants were also more likely than controls to have a positive test result (relative risk, 1.49) and to receive treatment (relative risk, 1.70).

The incremental cost-effectiveness ratio for increased screening uptake, defined as the incremental difference in cost between the study groups divided by the difference in the number of participants completing screening within 6 months, ranged from $85.84 per additional completed screening to $146.29, depending on the health system and test considered.

In terms of willingness-to-pay (WTP) thresholds for each additional completed screening, the team found that home-based screening achieved a 90% probability of cost-effectiveness, at a WTP of just $148 if the participant’s last Pap test was between 3.4 and 5.0 years before randomization.

A 90% probability of cost-effectiveness was also achieved at a WTP of $198 among participants aged 50-64 years, a threshold that was lower than that among other age groups.

At a WTP threshold of over $350, the intervention was considered to have 100% probability of being cost-effective in all age groups.

The study was supported by a grant from the National Cancer Institute of the National Institutes of Health. Dr. Winer reports a relationship with the National Cancer Institute outside of the submitted work, as do several other authors.

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

Sports-related sudden cardiac arrest (Sr-SCA) appears to be extremely rare in women, compared with men, despite similar characteristics and circumstances of occurrence, data from three European population-based registries suggest.

“Our study shows that cardiac arrest during sports activities is up to 13 times less frequent in women, which means that the risk of sports-related cardiac arrest is substantially lower in women than in men. This tighter risk is consistent across all age subgroups and registries,” Orianne Weizman, MD, MPH, Université Paris Cité, said in an interview.

“Even if it is a nonconsensual suggestion, the question of risk-adapted screening in women must be asked,” Dr. Weizman and colleagues propose.

Their study was published online  in the Journal of the American College of Cardiology.
 

Annual incidence

Among 34,826 cases of SCA in the registries that occurred in adults between 2006 and 2017, 760 (2.2%) were related to sports, and the vast majority occurred in men (706, 92.9%). Only 54 (7.1%) occurred in women.

Viktor Cap/Thinkstock

Overall, the average annual incidence of Sr-SCA in women was 0.19 per million, compared with 2.63 per million in men (P < .0001).

When extrapolating to the total European population and accounting for age and sex, this translates into 98 expected cases of Sr-SCA each year in women versus 1,350 cases annually in men.

The average age of Sr-SCA was similar in women and men (59 years). Most cases occurred during moderate-vigorous physical activity, although data on the types of sports and time spent on sports per week or month were not defined.

However, the investigators note that women with Sr-SCA were more likely than men to be engaged in light or moderate physical activity at the time of arrest (17.5% vs. 4.2%) – suggesting a potential higher propensity for women to present with SCA at moderate workloads.

The incidence of Sr-SCA increased only slightly in postmenopausal women, while there was an 8-fold increase in men aged 60-74 years, relative to peers younger than 40 years.

History of heart disease was relatively uncommon in both men and women. Previous myocardial infarction was the most frequent preexisting condition in men (26.8%), whereas nonischemic heart disease (cardiomyopathy and valvular heart disease) was more frequent among women (29.0%).

Cardiovascular risk factors were frequently present in both men and women, with at least one factor present in two-thirds of the patients, regardless of sex.

Pulseless electrical activity and asystole were more common in women than in men (40.7% vs. 19.1%), as has been shown in previous studies of resuscitation from SCA in the general population. Ventricular tachycardia or fibrillation was the initial rhythm in 80.9% of men and 59.3% of women.

The cause of SCA was MI in 31.4% of women and 29.0% of men. Other cases were related to dilated cardiomyopathy (5.6% in women, 1.8% in men) or hypertrophic cardiomyopathy (1.9% in women, 1.3% in men). Electrical heart disease was found in two women (3.7%) and 15 men (2.1%).

In most cases (86%), one or more witnesses were present and assisted after the collapse. There was no significant difference between men and women in bystander response, time to defibrillation, and survival, which approached 60% at hospital discharge with early bystander cardiorespiratory resuscitation and automatic external defibrillator use.

A limitation of the study is a predominantly White European population, meaning that the findings may not be extrapolated to other populations.
 

Tailored screening?

“These findings raise questions about the causes of this extremely low risk, which are not yet clear, and the extent to which we should revise our pre-sport screening methods,” Dr. Weizman told this news organization.

“We suggest that extensive, routinely conducted screening in women would not be cost-effective because of the extremely rare incidence of serious events,” Dr. Weizman said.

What’s lacking, however, is sport-specific data on whether specific activities (endurance or resistance) would be more risky for women. Further information, particularly on the sports at highest risk for Sr-SCA in women, is needed to propose tailor-made screening algorithms, Dr. Weizman noted.

The value of preparticipation screening for occult heart disease beyond the history and physical examination has been debated, with some organizations recommending electrocardiogram in addition to baseline assessments.

But this can lead to false-positives, “with the anxiety and cost associated with additional testing,” Anne Curtis, MD, State University of New York at Buffalo, Buffalo General Medical Center, and Jan Tijssen, PhD, University of Amsterdam, write in a linked editorial.

Currently, the American Heart Association recommends screening before sports participation, with a focused personal and family history and physical examination.

Dr. Curtis told this news organization that the U.S. guidelines “should stay as they are, but if one were to change them, it would be important to recognize that male athletes are much more likely to suffer arrhythmic events during sports than female athletes.”

“That to me means that female athletes in particular should not need to have ECGs prior to sports participation unless the history and physical examination detects a potential problem that needs further investigation,” Dr. Curtis said.

“Both women and men should be screened for cardiovascular risk factors during routine primary care, with appropriate interventions for hypertension, hyperlipidemia, smoking, and other risk factors,” Dr. Curtis and Dr. Tijssen advise in their editorial.

“In asymptomatic individuals who wish to become more active, in most cases they should be given the green light to proceed, starting slow and increasing intensity/duration over time, without specific additional testing. This advice is particularly relevant for women, given the findings of the current and prior studies,” they add.

This research was funded by Horizon 2020 and COST Action PARQ, supported by the European Cooperation in Science and Technology. Additional support was provided by INSERM, University of Paris, Assistance Publique-Hôpitaux de Paris, Fondation Coeur et Artères, Global Heart Watch, Fédération Française de Cardiologie, Société Française de Cardiologie, Fondation Recherche Medicale, as well as unrestricted grants from industrial partners. The authors and Dr. Tijssen have declared no relevant financial relationships. Dr. Curtis has disclosed relationships with Janssen several pharmaceutical companies.

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

Sports-related sudden cardiac arrest (Sr-SCA) appears to be extremely rare in women, compared with men, despite similar characteristics and circumstances of occurrence, data from three European population-based registries suggest.

“Our study shows that cardiac arrest during sports activities is up to 13 times less frequent in women, which means that the risk of sports-related cardiac arrest is substantially lower in women than in men. This tighter risk is consistent across all age subgroups and registries,” Orianne Weizman, MD, MPH, Université Paris Cité, said in an interview.

“Even if it is a nonconsensual suggestion, the question of risk-adapted screening in women must be asked,” Dr. Weizman and colleagues propose.

Their study was published online  in the Journal of the American College of Cardiology.
 

Annual incidence

Among 34,826 cases of SCA in the registries that occurred in adults between 2006 and 2017, 760 (2.2%) were related to sports, and the vast majority occurred in men (706, 92.9%). Only 54 (7.1%) occurred in women.

Viktor Cap/Thinkstock

Overall, the average annual incidence of Sr-SCA in women was 0.19 per million, compared with 2.63 per million in men (P < .0001).

When extrapolating to the total European population and accounting for age and sex, this translates into 98 expected cases of Sr-SCA each year in women versus 1,350 cases annually in men.

The average age of Sr-SCA was similar in women and men (59 years). Most cases occurred during moderate-vigorous physical activity, although data on the types of sports and time spent on sports per week or month were not defined.

However, the investigators note that women with Sr-SCA were more likely than men to be engaged in light or moderate physical activity at the time of arrest (17.5% vs. 4.2%) – suggesting a potential higher propensity for women to present with SCA at moderate workloads.

The incidence of Sr-SCA increased only slightly in postmenopausal women, while there was an 8-fold increase in men aged 60-74 years, relative to peers younger than 40 years.

History of heart disease was relatively uncommon in both men and women. Previous myocardial infarction was the most frequent preexisting condition in men (26.8%), whereas nonischemic heart disease (cardiomyopathy and valvular heart disease) was more frequent among women (29.0%).

Cardiovascular risk factors were frequently present in both men and women, with at least one factor present in two-thirds of the patients, regardless of sex.

Pulseless electrical activity and asystole were more common in women than in men (40.7% vs. 19.1%), as has been shown in previous studies of resuscitation from SCA in the general population. Ventricular tachycardia or fibrillation was the initial rhythm in 80.9% of men and 59.3% of women.

The cause of SCA was MI in 31.4% of women and 29.0% of men. Other cases were related to dilated cardiomyopathy (5.6% in women, 1.8% in men) or hypertrophic cardiomyopathy (1.9% in women, 1.3% in men). Electrical heart disease was found in two women (3.7%) and 15 men (2.1%).

In most cases (86%), one or more witnesses were present and assisted after the collapse. There was no significant difference between men and women in bystander response, time to defibrillation, and survival, which approached 60% at hospital discharge with early bystander cardiorespiratory resuscitation and automatic external defibrillator use.

A limitation of the study is a predominantly White European population, meaning that the findings may not be extrapolated to other populations.
 

Tailored screening?

“These findings raise questions about the causes of this extremely low risk, which are not yet clear, and the extent to which we should revise our pre-sport screening methods,” Dr. Weizman told this news organization.

“We suggest that extensive, routinely conducted screening in women would not be cost-effective because of the extremely rare incidence of serious events,” Dr. Weizman said.

What’s lacking, however, is sport-specific data on whether specific activities (endurance or resistance) would be more risky for women. Further information, particularly on the sports at highest risk for Sr-SCA in women, is needed to propose tailor-made screening algorithms, Dr. Weizman noted.

The value of preparticipation screening for occult heart disease beyond the history and physical examination has been debated, with some organizations recommending electrocardiogram in addition to baseline assessments.

But this can lead to false-positives, “with the anxiety and cost associated with additional testing,” Anne Curtis, MD, State University of New York at Buffalo, Buffalo General Medical Center, and Jan Tijssen, PhD, University of Amsterdam, write in a linked editorial.

Currently, the American Heart Association recommends screening before sports participation, with a focused personal and family history and physical examination.

Dr. Curtis told this news organization that the U.S. guidelines “should stay as they are, but if one were to change them, it would be important to recognize that male athletes are much more likely to suffer arrhythmic events during sports than female athletes.”

“That to me means that female athletes in particular should not need to have ECGs prior to sports participation unless the history and physical examination detects a potential problem that needs further investigation,” Dr. Curtis said.

“Both women and men should be screened for cardiovascular risk factors during routine primary care, with appropriate interventions for hypertension, hyperlipidemia, smoking, and other risk factors,” Dr. Curtis and Dr. Tijssen advise in their editorial.

“In asymptomatic individuals who wish to become more active, in most cases they should be given the green light to proceed, starting slow and increasing intensity/duration over time, without specific additional testing. This advice is particularly relevant for women, given the findings of the current and prior studies,” they add.

This research was funded by Horizon 2020 and COST Action PARQ, supported by the European Cooperation in Science and Technology. Additional support was provided by INSERM, University of Paris, Assistance Publique-Hôpitaux de Paris, Fondation Coeur et Artères, Global Heart Watch, Fédération Française de Cardiologie, Société Française de Cardiologie, Fondation Recherche Medicale, as well as unrestricted grants from industrial partners. The authors and Dr. Tijssen have declared no relevant financial relationships. Dr. Curtis has disclosed relationships with Janssen several pharmaceutical companies.

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

Sports-related sudden cardiac arrest (Sr-SCA) appears to be extremely rare in women, compared with men, despite similar characteristics and circumstances of occurrence, data from three European population-based registries suggest.

“Our study shows that cardiac arrest during sports activities is up to 13 times less frequent in women, which means that the risk of sports-related cardiac arrest is substantially lower in women than in men. This tighter risk is consistent across all age subgroups and registries,” Orianne Weizman, MD, MPH, Université Paris Cité, said in an interview.

“Even if it is a nonconsensual suggestion, the question of risk-adapted screening in women must be asked,” Dr. Weizman and colleagues propose.

Their study was published online  in the Journal of the American College of Cardiology.
 

Annual incidence

Among 34,826 cases of SCA in the registries that occurred in adults between 2006 and 2017, 760 (2.2%) were related to sports, and the vast majority occurred in men (706, 92.9%). Only 54 (7.1%) occurred in women.

Viktor Cap/Thinkstock

Overall, the average annual incidence of Sr-SCA in women was 0.19 per million, compared with 2.63 per million in men (P < .0001).

When extrapolating to the total European population and accounting for age and sex, this translates into 98 expected cases of Sr-SCA each year in women versus 1,350 cases annually in men.

The average age of Sr-SCA was similar in women and men (59 years). Most cases occurred during moderate-vigorous physical activity, although data on the types of sports and time spent on sports per week or month were not defined.

However, the investigators note that women with Sr-SCA were more likely than men to be engaged in light or moderate physical activity at the time of arrest (17.5% vs. 4.2%) – suggesting a potential higher propensity for women to present with SCA at moderate workloads.

The incidence of Sr-SCA increased only slightly in postmenopausal women, while there was an 8-fold increase in men aged 60-74 years, relative to peers younger than 40 years.

History of heart disease was relatively uncommon in both men and women. Previous myocardial infarction was the most frequent preexisting condition in men (26.8%), whereas nonischemic heart disease (cardiomyopathy and valvular heart disease) was more frequent among women (29.0%).

Cardiovascular risk factors were frequently present in both men and women, with at least one factor present in two-thirds of the patients, regardless of sex.

Pulseless electrical activity and asystole were more common in women than in men (40.7% vs. 19.1%), as has been shown in previous studies of resuscitation from SCA in the general population. Ventricular tachycardia or fibrillation was the initial rhythm in 80.9% of men and 59.3% of women.

The cause of SCA was MI in 31.4% of women and 29.0% of men. Other cases were related to dilated cardiomyopathy (5.6% in women, 1.8% in men) or hypertrophic cardiomyopathy (1.9% in women, 1.3% in men). Electrical heart disease was found in two women (3.7%) and 15 men (2.1%).

In most cases (86%), one or more witnesses were present and assisted after the collapse. There was no significant difference between men and women in bystander response, time to defibrillation, and survival, which approached 60% at hospital discharge with early bystander cardiorespiratory resuscitation and automatic external defibrillator use.

A limitation of the study is a predominantly White European population, meaning that the findings may not be extrapolated to other populations.
 

Tailored screening?

“These findings raise questions about the causes of this extremely low risk, which are not yet clear, and the extent to which we should revise our pre-sport screening methods,” Dr. Weizman told this news organization.

“We suggest that extensive, routinely conducted screening in women would not be cost-effective because of the extremely rare incidence of serious events,” Dr. Weizman said.

What’s lacking, however, is sport-specific data on whether specific activities (endurance or resistance) would be more risky for women. Further information, particularly on the sports at highest risk for Sr-SCA in women, is needed to propose tailor-made screening algorithms, Dr. Weizman noted.

The value of preparticipation screening for occult heart disease beyond the history and physical examination has been debated, with some organizations recommending electrocardiogram in addition to baseline assessments.

But this can lead to false-positives, “with the anxiety and cost associated with additional testing,” Anne Curtis, MD, State University of New York at Buffalo, Buffalo General Medical Center, and Jan Tijssen, PhD, University of Amsterdam, write in a linked editorial.

Currently, the American Heart Association recommends screening before sports participation, with a focused personal and family history and physical examination.

Dr. Curtis told this news organization that the U.S. guidelines “should stay as they are, but if one were to change them, it would be important to recognize that male athletes are much more likely to suffer arrhythmic events during sports than female athletes.”

“That to me means that female athletes in particular should not need to have ECGs prior to sports participation unless the history and physical examination detects a potential problem that needs further investigation,” Dr. Curtis said.

“Both women and men should be screened for cardiovascular risk factors during routine primary care, with appropriate interventions for hypertension, hyperlipidemia, smoking, and other risk factors,” Dr. Curtis and Dr. Tijssen advise in their editorial.

“In asymptomatic individuals who wish to become more active, in most cases they should be given the green light to proceed, starting slow and increasing intensity/duration over time, without specific additional testing. This advice is particularly relevant for women, given the findings of the current and prior studies,” they add.

This research was funded by Horizon 2020 and COST Action PARQ, supported by the European Cooperation in Science and Technology. Additional support was provided by INSERM, University of Paris, Assistance Publique-Hôpitaux de Paris, Fondation Coeur et Artères, Global Heart Watch, Fédération Française de Cardiologie, Société Française de Cardiologie, Fondation Recherche Medicale, as well as unrestricted grants from industrial partners. The authors and Dr. Tijssen have declared no relevant financial relationships. Dr. Curtis has disclosed relationships with Janssen several pharmaceutical companies.

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

Intrauterine device (IUD) placement at 2-4 weeks postpartum was noninferior to placement at 6-8 weeks postpartum for complete expulsion, and carried only a slightly higher risk of partial expulsion. A randomized study of expulsion rates reports the risk of expulsion at these points may help patients and clinicians make informed choices about the timing of IUD insertion, wrote the study authors, led by Sarah H. Averbach, MD, MAS, an obstetrician-gynecologist at the University of California, San Diego. “We found that the risk of complete IUD expulsion was low at 2% after early IUD placement 2-4 weeks after delivery, and was noninferior to interval placement 6-8 weeks after delivery at 0%,” Dr. Averbach said in an interview.

Although the risks of partial expulsion and malposition were modestly greater after early placement, “the possibility of a small increase in the risk of IUD expulsion or malposition with early IUD placement should be weighed against the risk of undesired pregnancy and short-interval pregnancy by delaying placement.”

University of California, San Diego

The timing of IUD placement in the postpartum period should be guided by patients’ goals and preferences, she added. The early postpartum period 2-4 weeks after birth has the advantage of convenience since it coincides with early-postpartum or well-baby visits. The absolute risk differences observed between early and interval placement were small for both complete or partial expulsion at 3.8%, and the rate for complete expulsion after early placement was much lower than historical expulsion rates for immediate postpartum placement within in few days of delivery.

Last year, a large study showed an increase in expulsion risk with IUD insertion within 3 days of delivery. Current guidelines, however, support immediate insertion as a safe practice.

The study

Enrolling 404 participants from diverse settings during the period of 2018 to July 2021, researchers for the noninferiority trial randomly assigned 203 to early IUD placement 14-28 days postpartum and 201 to standard-interval placement at 42-56 days. Patients had a mean age of 29.9 years, 11.4% were Black, 56.4% were White, and 43.3% were Hispanic (some Hispanic participants self-identified as White and some as Black). By 6 months postpartum, 73% of the cohort had received an IUD and completed 6-months of follow-up, while 13% had never received an IUD and 14% were lost to follow-up. Complete expulsion rates were 3 of 149, or 2.0% (95% confidence interval [CI], 0.4-5.8) in the early group and 0 of 145, or 0% (95% CI, 0.0-2.5) in the standard group, for a between-group difference of 2.0 percentage points (95% CI, −0.5 to 5.7, P = .04). Two women chose to replace their IUDs.

Partial expulsion occurred in 14, or 9.4% (95% CI, 5.2-15.3) of patients in the early group and 11, or 7.6% (95% CI, 3.9-13.2) in the standard-interval group, for a between-group difference of 1.8 (95% CI, −4.8 to 8.6) percentage points (P = .22).

The small absolute increase in risk of partial expulsion in the early arm did not meet the prespecified criterion for noninferiority of 6%. Three pelvic infections occurred in the early placement arm.

There were 42 IUD removals: 25 in the early placement group and 17 in the standard interval group. Thirteen participants had their IUDs removed for symptoms such as cramping and bothersome vaginal bleeding.

No perforations were identified in either group at 6 months, suggesting that the rate of uterine perforations is low when IUDs are placed in the early and standard-interval postpartum periods. IUD use at 6 months remained comparable between arms: 69.5% in the early group vs. 67.2% in the standard-interval group.

Commenting on the trial but not involved in it, Maureen K. Baldwin, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland, said it provides further data on the prevalence of expulsion and malposition after placements using ultrasonography as needed. While two failures occurred with asymptomatic malposition, she added, “It should be noted that IUD position can change as a result of pregnancy, so it was not determined that malposition occurred prior to contraceptive failure.”

Oregon Health &amp; Science University

According to Dr. Baldwin, one strategy to reduce concerns is to use transvaginal ultrasonography at a later time or in the presence of unusual symptoms.

Overall, the study establishes that postpartum placement is an option equivalent to standard timing and it should be incorporated into patient preferences, she said. “Pain may be lowest at early placement compared to other timings, particularly for those who had vaginal birth.”

The study was supported by the Society of Family Planning research fund and the National Institutes of Health - National Institute of Child Health and Human Development. Dr. Averbach reported personal fees from Bayer Pharmaceuticals for advice on postpartum IUD placement as well as grants from the NIH outside of the submitted work. Dr. Baldwin disclosed no potential conflicts of interest with regard to her comments.

Intrauterine device (IUD) placement at 2-4 weeks postpartum was noninferior to placement at 6-8 weeks postpartum for complete expulsion, and carried only a slightly higher risk of partial expulsion. A randomized study of expulsion rates reports the risk of expulsion at these points may help patients and clinicians make informed choices about the timing of IUD insertion, wrote the study authors, led by Sarah H. Averbach, MD, MAS, an obstetrician-gynecologist at the University of California, San Diego. “We found that the risk of complete IUD expulsion was low at 2% after early IUD placement 2-4 weeks after delivery, and was noninferior to interval placement 6-8 weeks after delivery at 0%,” Dr. Averbach said in an interview.

Although the risks of partial expulsion and malposition were modestly greater after early placement, “the possibility of a small increase in the risk of IUD expulsion or malposition with early IUD placement should be weighed against the risk of undesired pregnancy and short-interval pregnancy by delaying placement.”

University of California, San Diego

The timing of IUD placement in the postpartum period should be guided by patients’ goals and preferences, she added. The early postpartum period 2-4 weeks after birth has the advantage of convenience since it coincides with early-postpartum or well-baby visits. The absolute risk differences observed between early and interval placement were small for both complete or partial expulsion at 3.8%, and the rate for complete expulsion after early placement was much lower than historical expulsion rates for immediate postpartum placement within in few days of delivery.

Last year, a large study showed an increase in expulsion risk with IUD insertion within 3 days of delivery. Current guidelines, however, support immediate insertion as a safe practice.

The study

Enrolling 404 participants from diverse settings during the period of 2018 to July 2021, researchers for the noninferiority trial randomly assigned 203 to early IUD placement 14-28 days postpartum and 201 to standard-interval placement at 42-56 days. Patients had a mean age of 29.9 years, 11.4% were Black, 56.4% were White, and 43.3% were Hispanic (some Hispanic participants self-identified as White and some as Black). By 6 months postpartum, 73% of the cohort had received an IUD and completed 6-months of follow-up, while 13% had never received an IUD and 14% were lost to follow-up. Complete expulsion rates were 3 of 149, or 2.0% (95% confidence interval [CI], 0.4-5.8) in the early group and 0 of 145, or 0% (95% CI, 0.0-2.5) in the standard group, for a between-group difference of 2.0 percentage points (95% CI, −0.5 to 5.7, P = .04). Two women chose to replace their IUDs.

Partial expulsion occurred in 14, or 9.4% (95% CI, 5.2-15.3) of patients in the early group and 11, or 7.6% (95% CI, 3.9-13.2) in the standard-interval group, for a between-group difference of 1.8 (95% CI, −4.8 to 8.6) percentage points (P = .22).

The small absolute increase in risk of partial expulsion in the early arm did not meet the prespecified criterion for noninferiority of 6%. Three pelvic infections occurred in the early placement arm.

There were 42 IUD removals: 25 in the early placement group and 17 in the standard interval group. Thirteen participants had their IUDs removed for symptoms such as cramping and bothersome vaginal bleeding.

No perforations were identified in either group at 6 months, suggesting that the rate of uterine perforations is low when IUDs are placed in the early and standard-interval postpartum periods. IUD use at 6 months remained comparable between arms: 69.5% in the early group vs. 67.2% in the standard-interval group.

Commenting on the trial but not involved in it, Maureen K. Baldwin, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland, said it provides further data on the prevalence of expulsion and malposition after placements using ultrasonography as needed. While two failures occurred with asymptomatic malposition, she added, “It should be noted that IUD position can change as a result of pregnancy, so it was not determined that malposition occurred prior to contraceptive failure.”

Oregon Health &amp; Science University

According to Dr. Baldwin, one strategy to reduce concerns is to use transvaginal ultrasonography at a later time or in the presence of unusual symptoms.

Overall, the study establishes that postpartum placement is an option equivalent to standard timing and it should be incorporated into patient preferences, she said. “Pain may be lowest at early placement compared to other timings, particularly for those who had vaginal birth.”

The study was supported by the Society of Family Planning research fund and the National Institutes of Health - National Institute of Child Health and Human Development. Dr. Averbach reported personal fees from Bayer Pharmaceuticals for advice on postpartum IUD placement as well as grants from the NIH outside of the submitted work. Dr. Baldwin disclosed no potential conflicts of interest with regard to her comments.

Intrauterine device (IUD) placement at 2-4 weeks postpartum was noninferior to placement at 6-8 weeks postpartum for complete expulsion, and carried only a slightly higher risk of partial expulsion. A randomized study of expulsion rates reports the risk of expulsion at these points may help patients and clinicians make informed choices about the timing of IUD insertion, wrote the study authors, led by Sarah H. Averbach, MD, MAS, an obstetrician-gynecologist at the University of California, San Diego. “We found that the risk of complete IUD expulsion was low at 2% after early IUD placement 2-4 weeks after delivery, and was noninferior to interval placement 6-8 weeks after delivery at 0%,” Dr. Averbach said in an interview.

Although the risks of partial expulsion and malposition were modestly greater after early placement, “the possibility of a small increase in the risk of IUD expulsion or malposition with early IUD placement should be weighed against the risk of undesired pregnancy and short-interval pregnancy by delaying placement.”

University of California, San Diego

The timing of IUD placement in the postpartum period should be guided by patients’ goals and preferences, she added. The early postpartum period 2-4 weeks after birth has the advantage of convenience since it coincides with early-postpartum or well-baby visits. The absolute risk differences observed between early and interval placement were small for both complete or partial expulsion at 3.8%, and the rate for complete expulsion after early placement was much lower than historical expulsion rates for immediate postpartum placement within in few days of delivery.

Last year, a large study showed an increase in expulsion risk with IUD insertion within 3 days of delivery. Current guidelines, however, support immediate insertion as a safe practice.

The study

Enrolling 404 participants from diverse settings during the period of 2018 to July 2021, researchers for the noninferiority trial randomly assigned 203 to early IUD placement 14-28 days postpartum and 201 to standard-interval placement at 42-56 days. Patients had a mean age of 29.9 years, 11.4% were Black, 56.4% were White, and 43.3% were Hispanic (some Hispanic participants self-identified as White and some as Black). By 6 months postpartum, 73% of the cohort had received an IUD and completed 6-months of follow-up, while 13% had never received an IUD and 14% were lost to follow-up. Complete expulsion rates were 3 of 149, or 2.0% (95% confidence interval [CI], 0.4-5.8) in the early group and 0 of 145, or 0% (95% CI, 0.0-2.5) in the standard group, for a between-group difference of 2.0 percentage points (95% CI, −0.5 to 5.7, P = .04). Two women chose to replace their IUDs.

Partial expulsion occurred in 14, or 9.4% (95% CI, 5.2-15.3) of patients in the early group and 11, or 7.6% (95% CI, 3.9-13.2) in the standard-interval group, for a between-group difference of 1.8 (95% CI, −4.8 to 8.6) percentage points (P = .22).

The small absolute increase in risk of partial expulsion in the early arm did not meet the prespecified criterion for noninferiority of 6%. Three pelvic infections occurred in the early placement arm.

There were 42 IUD removals: 25 in the early placement group and 17 in the standard interval group. Thirteen participants had their IUDs removed for symptoms such as cramping and bothersome vaginal bleeding.

No perforations were identified in either group at 6 months, suggesting that the rate of uterine perforations is low when IUDs are placed in the early and standard-interval postpartum periods. IUD use at 6 months remained comparable between arms: 69.5% in the early group vs. 67.2% in the standard-interval group.

Commenting on the trial but not involved in it, Maureen K. Baldwin, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland, said it provides further data on the prevalence of expulsion and malposition after placements using ultrasonography as needed. While two failures occurred with asymptomatic malposition, she added, “It should be noted that IUD position can change as a result of pregnancy, so it was not determined that malposition occurred prior to contraceptive failure.”

Oregon Health &amp; Science University

According to Dr. Baldwin, one strategy to reduce concerns is to use transvaginal ultrasonography at a later time or in the presence of unusual symptoms.

Overall, the study establishes that postpartum placement is an option equivalent to standard timing and it should be incorporated into patient preferences, she said. “Pain may be lowest at early placement compared to other timings, particularly for those who had vaginal birth.”

The study was supported by the Society of Family Planning research fund and the National Institutes of Health - National Institute of Child Health and Human Development. Dr. Averbach reported personal fees from Bayer Pharmaceuticals for advice on postpartum IUD placement as well as grants from the NIH outside of the submitted work. Dr. Baldwin disclosed no potential conflicts of interest with regard to her comments.

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

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

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

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

A substantial number of older women may experience worsening frailty after undergoing surgery and radiation therapy for early-stage breast cancer, according to a new study.

About 1 in 5 experienced clinically significant deterioration in frailty status after treatment, the study team found. Women at highest risk for declines in frailty following treatment had “robust” baseline frailty status at diagnosis and underwent more invasive mastectomy compared with lumpectomy.

The fact that “robust” older women were more likely to become frail after locoregional therapy suggests that “thoughtful treatment decisions should be undertaken in all older women, not simply those who have frailty at diagnosis,” said the investigators, led by Christina Minami, MD, of Dana-Farber/Brigham and Women’s Cancer Center in Boston.

The study findings emphasize that there is no one-size-fits-all approach to breast cancer treatment in the elderly, said Sarah P. Cate, MD, director, Breast Surgery Quality Program, Mount Sinai Health System, New York, who wasn’t involved in the research. “Some patients will sail through a surgery, and others are severely affected by it.”

The study was published online in JAMA Surgery.

Given the growing number of older adults with breast cancer, understanding how age-related syndromes, such as frailty, may alter cancer outcomes and how cancer treatments change aging trajectories remains important.

To investigate, Dr. Minami and colleagues used Surveillance, Epidemiology, and End Results Medicare data to identify 31,084 women (mean age, 73) who had been diagnosed with ductal carcinoma in situ (DCIS) or stage I HR-positive, ERBB2-positive breast cancer and who underwent surgery (23% mastectomy, 77% lumpectomy) and radiation therapy.

Worsening frailty status was defined as a decline of 0.03 or greater in a validated frailty index from the time of diagnosis to 1 year. This level of change has been linked to greater mortality risk and greater cost of care.

Frailty status at diagnosis was “robust” in 56% of the women, prefrail in 40%, mildly frail in 4%, and moderately to severely frail in 0.3%.

According to the researchers, 21.4% of the women experienced clinically significant declines in their frailty status after treatment. These declines occurred in 25% of women who underwent mastectomy and 20% of those who underwent lumpectomy.

After adjusting for covariates, there was a higher likelihood of worsening frailty among women who were robustly frail at baseline, in comparison with those who were moderately to severely frail at baseline (odds ratio, 6.12), and in those who underwent mastectomy vs. lumpectomy (OR, 1.31).

Older age and race were also linked to worsening frailty status following treatment. Compared with younger women (aged 65-74 years), older women were more likely to experience worsening frailty (OR, 1.21 for women aged 75-79; OR, 1.53 for those aged 80-84; OR, 1.94 for those aged 85 and older). In addition, Black women were more likely than non-Hispanic White women to experience worsening frailty after treatment (OR, 1.12).

“Previous studies have documented lasting declines in functional status after surgery in older patients with breast cancer, but breast cancer treatment has not been implicated in worsening frailty to date,” Dr. Minami and colleagues explain. But “given the substantial proportion of women experiencing worsening frailty and the significant difference by breast surgery type, frailty status as a cancer therapy outcome should be further explored.” In addition, “tailoring locoregional therapy intensity in this population is important,” they write.

Dr. Cate explained that randomized clinical trials such as COMET and LORIS, which explore the monitoring of patients with DCIS in lieu of active treatment, “will likely make a big impact on this population, as we currently do not have randomized controlled data for observation of breast cancer.”

Dr. Cate added as well that assessing a patient’s ECOG [Eastern Cooperative Oncology Group] performance status is vital “to determine who can really tolerate a breast cancer surgery” and that opting for antiestrogens, such as aromatase inhibitors, which can keep cancer at bay for years, “may be preferable for many older patients.”

The study was funded by Brigham and Women’s Hospital’s Department of Surgery’s Beal Fellowship. Dr. Minami and Dr. Cate have disclosed no relevant financial relationships.
 

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