Women's Health

Vaginal estradiol tablets promoted significant changes in the vaginal microbiota in postmenopausal women compared with vaginal moisturizer or placebo, but reduction in bothersome symptoms were similar, based on data from 144 individuals.

“In the Menopause Strategies–Finding Lasting Answers and Health (MsFLASH) trial network’s Vaginal Health Trial of treatment for moderate to severe vaginal symptoms of menopause, there were no significant differences in reduction of vaginal symptoms among women using the estradiol vaginal tablet or vaginal moisturizer compared to women using the placebo regimen; all three groups had a reduction in vaginal symptoms,” lead author Sujatha Srinivasan, PhD, of the Fred Hutchinson Cancer Center, Seattle, said in an interview.

“However, the impact of these treatments on the vaginal microenvironment are poorly understood,” she said.

In a study published in JAMA Network Open, Dr. Srinivasan and colleagues conducted a secondary analysis to examine the effects of estradiol or a low-pH vaginal moisturizer on the vaginal microbiota, metabolome, and pH after 12 weeks of treatment vs. a low-pH placebo.

“Changes, or lack thereof, in the vaginal microenvironment might have implications beyond symptoms, and might be linked to risk for cervical cancer, genital infections, or other outcomes, though our study did not evaluate those associations,” Dr. Srinivasan said in an interview. Dr. Srinivasan’s comments were corroborated by coauthor Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston.

The study population included postmenopausal women with moderate to severe genitourinary symptoms who were enrolled in a randomized, controlled trial between April 2016 and February 2017. The average age of the women was 61 years, and 90% were White. The women were randomized to 10 mcg vaginal estradiol plus placebo gel, placebo tablet plus vaginal moisturizer, or a dual placebo.

The primary outcome in the original study was a change in the reported most bothersome symptoms (MBS) selected by the participants at the time of study enrollment; these included pain with penetration, vaginal dryness, and vulvovaginal irritation, itching, and pain. The main outcomes in the secondary analysis were changes in the diversity and composition of the vaginal microbiota, changes in the metabolome, and pH. Microbiota diversity was calculated via the Shannon Diversity Index (SDI).

After 12 weeks, the bacterial microbiota were dominated by Lactobacillus and Bifidobacterium in 80% of the estradiol group, 36% of the moisturizer group, and 26% of the placebo group (P < .001).

In addition, diversity analysis showed significant changes in bacterial composition in women in the estradiol group compared with the placebo group, but no significant differences between the moisturizer and placebo groups.

The composition of vaginal fluid small molecule metabolites changed significantly in 90 of 171 metabolites measured in the estradiol group from baseline to 12 weeks. Changes in the moisturizer and placebo groups were not significant.

Vaginal pH among women in the estradiol group was significantly lower than placebo at 12 weeks, with a median of 5 vs. 6 (P = .005). No significant difference in pH occurred for women in the moisturizer group. “However, pH significantly decreased over 12 weeks within each treatment group, reflecting the low-pH formulations of both the moisturizer and the placebo,” the researchers wrote.

Overall, women with high-diversity bacterial communities at baseline showed a greater median change in pH compared with women with low-diversity communities (median change of −1 vs. −0.3, P = .007).

Improvement in MBS symptoms by at least 2 points occurred in 53% of the estradiol group, 44% of the moisturizer group, and 49% of the placebo group. The similarity in severe symptom improvement among the groups confirms the lack of a causal association between microbiota and postmenopausal vaginal symptom severity, the researchers wrote.

“This study demonstrated that a decrease in vaginal pH alone was insufficient to change the vaginal microbiota,” Dr. Srinivasan said. “While the changes with estrogen were somewhat expected, the observation that low-pH vaginal products don’t change the vaginal microbiota is contrary to some expectations, and suggests that “low-pH” products may not be as helpful as their marketing claims,” she added. “A vaginal microbiota with an abundance of lactobacilli, a vaginal microenvironment with high concentrations of lactate, and a low vaginal pH is associated with health in premenopausal women. We also know that such a microenvironment is typically associated with low inflammation,” said Dr. Srinivasan. “At this time, we don’t have specific information as to how this is beneficial to postmenopausal women,” she noted. However, “If we extrapolate from the data on premenopausal women, the data from this secondary analysis suggests that vaginal estradiol may have positive impacts on the vaginal microenvironment regardless of impact on symptoms,” she said.

“Future areas of investigation should focus on understanding potential benefits of a Lactobacillus-dominant microbiota in postmenopausal women,” Dr. Srinivasan said.

The study findings were limited by several factors including the relatively small number of participants, and collection of data samples at only three time periods, as well as the lack of data on whether the observed changes are durable over longer treatment times, the researchers noted.

“The need to increase participant diversity in studies of postmenopausal women is highlighted by our finding that the 6 Black women in our analysis were all categorized in the low-diversity subgroup; data from premenopausal women suggest that Black women have diverse bacterial communities,” they added.

However, the results suggest that “a significant decrease in pH over the course of a trial may not reflect the same underlying biological processes among different interventions, and thus, lowering pH should not be a primary goal,” they concluded.
 

Estradiol may have limited clinical impact

“For postmenopausal women with dyspareunia, vaginal dryness, and/or burning/itching/irritation, the question of appropriate treatment is common,” Constance Bohon, MD, a gynecologist in private practice in Washington, said in an interview. “It is helpful to have a study that focuses on the benefit of a moisturizer as compared with vaginal estrogen for these women,” she said.

Dr. Bohon said she was not surprised with the benefits of the moisturizer for dyspareunia and vaginal dryness. “What did surprise me was that the complaint of vaginal itch, burn, or irritation was not significantly improved in the vaginal estrogen group compared with the moisturizer group. I assumed that estrogen would have been more beneficial in this group because these symptoms are more likely to be caused by a vaginal infection that would not be improved with moisturizer alone,” she said. “I expected that the change in the vaginal flora to increase Lactobacillus would have had a greater impact on an infection than the moisturizer, which did not significantly change the flora.”

For clinicians, the take-home message is that, for these patients, use of a moisturizer may be sufficient, Dr. Bohon said.

“Additional research should be done to assess each issue,” she noted. “For example, in the women who have pain with sex, what is the frequency of intercourse?” she asked. Other research should address the questions of whether women who have intercourse at least once a week have less dyspareunia than those who have less frequent sex, and whether a lubricant decreases dyspareunia as well as a moisturizer or vaginal estrogen, she added.

The study was supported by the National Institutes of Health. Dr. Srinivasan disclosed personal fees from Lupin unrelated to the current study. Dr. Bohon had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Vaginal estradiol tablets promoted significant changes in the vaginal microbiota in postmenopausal women compared with vaginal moisturizer or placebo, but reduction in bothersome symptoms were similar, based on data from 144 individuals.

“In the Menopause Strategies–Finding Lasting Answers and Health (MsFLASH) trial network’s Vaginal Health Trial of treatment for moderate to severe vaginal symptoms of menopause, there were no significant differences in reduction of vaginal symptoms among women using the estradiol vaginal tablet or vaginal moisturizer compared to women using the placebo regimen; all three groups had a reduction in vaginal symptoms,” lead author Sujatha Srinivasan, PhD, of the Fred Hutchinson Cancer Center, Seattle, said in an interview.

“However, the impact of these treatments on the vaginal microenvironment are poorly understood,” she said.

In a study published in JAMA Network Open, Dr. Srinivasan and colleagues conducted a secondary analysis to examine the effects of estradiol or a low-pH vaginal moisturizer on the vaginal microbiota, metabolome, and pH after 12 weeks of treatment vs. a low-pH placebo.

“Changes, or lack thereof, in the vaginal microenvironment might have implications beyond symptoms, and might be linked to risk for cervical cancer, genital infections, or other outcomes, though our study did not evaluate those associations,” Dr. Srinivasan said in an interview. Dr. Srinivasan’s comments were corroborated by coauthor Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston.

The study population included postmenopausal women with moderate to severe genitourinary symptoms who were enrolled in a randomized, controlled trial between April 2016 and February 2017. The average age of the women was 61 years, and 90% were White. The women were randomized to 10 mcg vaginal estradiol plus placebo gel, placebo tablet plus vaginal moisturizer, or a dual placebo.

The primary outcome in the original study was a change in the reported most bothersome symptoms (MBS) selected by the participants at the time of study enrollment; these included pain with penetration, vaginal dryness, and vulvovaginal irritation, itching, and pain. The main outcomes in the secondary analysis were changes in the diversity and composition of the vaginal microbiota, changes in the metabolome, and pH. Microbiota diversity was calculated via the Shannon Diversity Index (SDI).

After 12 weeks, the bacterial microbiota were dominated by Lactobacillus and Bifidobacterium in 80% of the estradiol group, 36% of the moisturizer group, and 26% of the placebo group (P < .001).

In addition, diversity analysis showed significant changes in bacterial composition in women in the estradiol group compared with the placebo group, but no significant differences between the moisturizer and placebo groups.

The composition of vaginal fluid small molecule metabolites changed significantly in 90 of 171 metabolites measured in the estradiol group from baseline to 12 weeks. Changes in the moisturizer and placebo groups were not significant.

Vaginal pH among women in the estradiol group was significantly lower than placebo at 12 weeks, with a median of 5 vs. 6 (P = .005). No significant difference in pH occurred for women in the moisturizer group. “However, pH significantly decreased over 12 weeks within each treatment group, reflecting the low-pH formulations of both the moisturizer and the placebo,” the researchers wrote.

Overall, women with high-diversity bacterial communities at baseline showed a greater median change in pH compared with women with low-diversity communities (median change of −1 vs. −0.3, P = .007).

Improvement in MBS symptoms by at least 2 points occurred in 53% of the estradiol group, 44% of the moisturizer group, and 49% of the placebo group. The similarity in severe symptom improvement among the groups confirms the lack of a causal association between microbiota and postmenopausal vaginal symptom severity, the researchers wrote.

“This study demonstrated that a decrease in vaginal pH alone was insufficient to change the vaginal microbiota,” Dr. Srinivasan said. “While the changes with estrogen were somewhat expected, the observation that low-pH vaginal products don’t change the vaginal microbiota is contrary to some expectations, and suggests that “low-pH” products may not be as helpful as their marketing claims,” she added. “A vaginal microbiota with an abundance of lactobacilli, a vaginal microenvironment with high concentrations of lactate, and a low vaginal pH is associated with health in premenopausal women. We also know that such a microenvironment is typically associated with low inflammation,” said Dr. Srinivasan. “At this time, we don’t have specific information as to how this is beneficial to postmenopausal women,” she noted. However, “If we extrapolate from the data on premenopausal women, the data from this secondary analysis suggests that vaginal estradiol may have positive impacts on the vaginal microenvironment regardless of impact on symptoms,” she said.

“Future areas of investigation should focus on understanding potential benefits of a Lactobacillus-dominant microbiota in postmenopausal women,” Dr. Srinivasan said.

The study findings were limited by several factors including the relatively small number of participants, and collection of data samples at only three time periods, as well as the lack of data on whether the observed changes are durable over longer treatment times, the researchers noted.

“The need to increase participant diversity in studies of postmenopausal women is highlighted by our finding that the 6 Black women in our analysis were all categorized in the low-diversity subgroup; data from premenopausal women suggest that Black women have diverse bacterial communities,” they added.

However, the results suggest that “a significant decrease in pH over the course of a trial may not reflect the same underlying biological processes among different interventions, and thus, lowering pH should not be a primary goal,” they concluded.
 

Estradiol may have limited clinical impact

“For postmenopausal women with dyspareunia, vaginal dryness, and/or burning/itching/irritation, the question of appropriate treatment is common,” Constance Bohon, MD, a gynecologist in private practice in Washington, said in an interview. “It is helpful to have a study that focuses on the benefit of a moisturizer as compared with vaginal estrogen for these women,” she said.

Dr. Bohon said she was not surprised with the benefits of the moisturizer for dyspareunia and vaginal dryness. “What did surprise me was that the complaint of vaginal itch, burn, or irritation was not significantly improved in the vaginal estrogen group compared with the moisturizer group. I assumed that estrogen would have been more beneficial in this group because these symptoms are more likely to be caused by a vaginal infection that would not be improved with moisturizer alone,” she said. “I expected that the change in the vaginal flora to increase Lactobacillus would have had a greater impact on an infection than the moisturizer, which did not significantly change the flora.”

For clinicians, the take-home message is that, for these patients, use of a moisturizer may be sufficient, Dr. Bohon said.

“Additional research should be done to assess each issue,” she noted. “For example, in the women who have pain with sex, what is the frequency of intercourse?” she asked. Other research should address the questions of whether women who have intercourse at least once a week have less dyspareunia than those who have less frequent sex, and whether a lubricant decreases dyspareunia as well as a moisturizer or vaginal estrogen, she added.

The study was supported by the National Institutes of Health. Dr. Srinivasan disclosed personal fees from Lupin unrelated to the current study. Dr. Bohon had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Vaginal estradiol tablets promoted significant changes in the vaginal microbiota in postmenopausal women compared with vaginal moisturizer or placebo, but reduction in bothersome symptoms were similar, based on data from 144 individuals.

“In the Menopause Strategies–Finding Lasting Answers and Health (MsFLASH) trial network’s Vaginal Health Trial of treatment for moderate to severe vaginal symptoms of menopause, there were no significant differences in reduction of vaginal symptoms among women using the estradiol vaginal tablet or vaginal moisturizer compared to women using the placebo regimen; all three groups had a reduction in vaginal symptoms,” lead author Sujatha Srinivasan, PhD, of the Fred Hutchinson Cancer Center, Seattle, said in an interview.

“However, the impact of these treatments on the vaginal microenvironment are poorly understood,” she said.

In a study published in JAMA Network Open, Dr. Srinivasan and colleagues conducted a secondary analysis to examine the effects of estradiol or a low-pH vaginal moisturizer on the vaginal microbiota, metabolome, and pH after 12 weeks of treatment vs. a low-pH placebo.

“Changes, or lack thereof, in the vaginal microenvironment might have implications beyond symptoms, and might be linked to risk for cervical cancer, genital infections, or other outcomes, though our study did not evaluate those associations,” Dr. Srinivasan said in an interview. Dr. Srinivasan’s comments were corroborated by coauthor Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston.

The study population included postmenopausal women with moderate to severe genitourinary symptoms who were enrolled in a randomized, controlled trial between April 2016 and February 2017. The average age of the women was 61 years, and 90% were White. The women were randomized to 10 mcg vaginal estradiol plus placebo gel, placebo tablet plus vaginal moisturizer, or a dual placebo.

The primary outcome in the original study was a change in the reported most bothersome symptoms (MBS) selected by the participants at the time of study enrollment; these included pain with penetration, vaginal dryness, and vulvovaginal irritation, itching, and pain. The main outcomes in the secondary analysis were changes in the diversity and composition of the vaginal microbiota, changes in the metabolome, and pH. Microbiota diversity was calculated via the Shannon Diversity Index (SDI).

After 12 weeks, the bacterial microbiota were dominated by Lactobacillus and Bifidobacterium in 80% of the estradiol group, 36% of the moisturizer group, and 26% of the placebo group (P < .001).

In addition, diversity analysis showed significant changes in bacterial composition in women in the estradiol group compared with the placebo group, but no significant differences between the moisturizer and placebo groups.

The composition of vaginal fluid small molecule metabolites changed significantly in 90 of 171 metabolites measured in the estradiol group from baseline to 12 weeks. Changes in the moisturizer and placebo groups were not significant.

Vaginal pH among women in the estradiol group was significantly lower than placebo at 12 weeks, with a median of 5 vs. 6 (P = .005). No significant difference in pH occurred for women in the moisturizer group. “However, pH significantly decreased over 12 weeks within each treatment group, reflecting the low-pH formulations of both the moisturizer and the placebo,” the researchers wrote.

Overall, women with high-diversity bacterial communities at baseline showed a greater median change in pH compared with women with low-diversity communities (median change of −1 vs. −0.3, P = .007).

Improvement in MBS symptoms by at least 2 points occurred in 53% of the estradiol group, 44% of the moisturizer group, and 49% of the placebo group. The similarity in severe symptom improvement among the groups confirms the lack of a causal association between microbiota and postmenopausal vaginal symptom severity, the researchers wrote.

“This study demonstrated that a decrease in vaginal pH alone was insufficient to change the vaginal microbiota,” Dr. Srinivasan said. “While the changes with estrogen were somewhat expected, the observation that low-pH vaginal products don’t change the vaginal microbiota is contrary to some expectations, and suggests that “low-pH” products may not be as helpful as their marketing claims,” she added. “A vaginal microbiota with an abundance of lactobacilli, a vaginal microenvironment with high concentrations of lactate, and a low vaginal pH is associated with health in premenopausal women. We also know that such a microenvironment is typically associated with low inflammation,” said Dr. Srinivasan. “At this time, we don’t have specific information as to how this is beneficial to postmenopausal women,” she noted. However, “If we extrapolate from the data on premenopausal women, the data from this secondary analysis suggests that vaginal estradiol may have positive impacts on the vaginal microenvironment regardless of impact on symptoms,” she said.

“Future areas of investigation should focus on understanding potential benefits of a Lactobacillus-dominant microbiota in postmenopausal women,” Dr. Srinivasan said.

The study findings were limited by several factors including the relatively small number of participants, and collection of data samples at only three time periods, as well as the lack of data on whether the observed changes are durable over longer treatment times, the researchers noted.

“The need to increase participant diversity in studies of postmenopausal women is highlighted by our finding that the 6 Black women in our analysis were all categorized in the low-diversity subgroup; data from premenopausal women suggest that Black women have diverse bacterial communities,” they added.

However, the results suggest that “a significant decrease in pH over the course of a trial may not reflect the same underlying biological processes among different interventions, and thus, lowering pH should not be a primary goal,” they concluded.
 

Estradiol may have limited clinical impact

“For postmenopausal women with dyspareunia, vaginal dryness, and/or burning/itching/irritation, the question of appropriate treatment is common,” Constance Bohon, MD, a gynecologist in private practice in Washington, said in an interview. “It is helpful to have a study that focuses on the benefit of a moisturizer as compared with vaginal estrogen for these women,” she said.

Dr. Bohon said she was not surprised with the benefits of the moisturizer for dyspareunia and vaginal dryness. “What did surprise me was that the complaint of vaginal itch, burn, or irritation was not significantly improved in the vaginal estrogen group compared with the moisturizer group. I assumed that estrogen would have been more beneficial in this group because these symptoms are more likely to be caused by a vaginal infection that would not be improved with moisturizer alone,” she said. “I expected that the change in the vaginal flora to increase Lactobacillus would have had a greater impact on an infection than the moisturizer, which did not significantly change the flora.”

For clinicians, the take-home message is that, for these patients, use of a moisturizer may be sufficient, Dr. Bohon said.

“Additional research should be done to assess each issue,” she noted. “For example, in the women who have pain with sex, what is the frequency of intercourse?” she asked. Other research should address the questions of whether women who have intercourse at least once a week have less dyspareunia than those who have less frequent sex, and whether a lubricant decreases dyspareunia as well as a moisturizer or vaginal estrogen, she added.

The study was supported by the National Institutes of Health. Dr. Srinivasan disclosed personal fees from Lupin unrelated to the current study. Dr. Bohon had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Pregnant women with even mild hypertension should receive blood pressure–lowering medications to reduce the likelihood of adverse outcomes for the mother and the child, according to a large, open-label, randomized trial.

“Treating to the blood pressure goal in this study reduced the risk of adverse events associated with pregnancy but did not impair fetal growth,” Alan T. Tita, MD, PhD, associate dean for Global and Women’s Health, University of Alabama, Birmingham, reported at the annual scientific sessions of the American College of Cardiology.

The question of whether to treat chronic hypertension during pregnancy has been “an international controversy for decades,” said Dr. Tita, who led the investigator-initiated Chronic Hypertension and Pregnancy (CHAP) trial.

For the composite primary outcome of severe preeclampsia, medically indicated preterm birth at less than 35 weeks of gestation, placental abruption, or fetal/neonatal death, the treatment of hypertension versus no treatment showed a relative risk reduction of 18% (30.2% vs. 37%, (hazard ratio, 0.82; P < .001).
 

Small for gestational age is primary safety endpoint

An increase in preeclampsia risk in women whose fetus was small for gestational age (SGA), a theoretical consequence of reductions in arterial pressure, was not seen. The rate of SGA, defined as below the 10^th percentile, was slightly higher in the treatment group (11.2% vs. 10.4%), but the difference did not approach significance (P = 0.76).

By answering this long-pending question, the CHAP data are “practice changing,” declared an ACC-invited commentator, Athena Poppas, MD, chief of cardiology and director of the Lifespan Cardiovascular Institute, Providence, R.I. She agreed that the need for treatment of mild chronic hypertension has been a dilemma for clinicians that is now acceptably resolved.

In this trial, 2,408 pregnant women with chronic mild hypertension defined as a blood pressure of 160/90 mm Hg were randomized to treatment with a goal blood pressure of less than 140/90 mm Hg or no treatment unless the blood pressure rose to at least 160/105. All women had singleton pregnancies. Enrollment before 23 weeks of gestation was required. Severe hypertension (at least 160/105 mm Hg) was an exclusion criterion, as were several comorbidities, such as kidney disease.
 

Combination therapy accepted for <140/90 mm Hg goal

The beta-blocker labetalol or the calcium channel blocker nifedipine as single agents were the preferred antihypertensive medications in the protocol, but other medications were permitted. To reach the blood pressure goal, the single-agent therapy was titrated to the maximum dose before starting a second agent.

After randomization the systolic and diastolic blood pressures fell in both groups, but they fell more and remained consistently lower in the active treatment group, particularly during the first 20 weeks after randomization, according to graphs displayed by Dr. Tita. Over the course of the study, the mean diastolic blood pressures were 129.5 and 132.6 mm Hg in the active treatment and control groups, respectively, while the systolic pressures were 79.1 vs. 81.5 mm Hg.

When the components of the primary outcome were evaluated separately, the greatest advantage of treatment was the reduction in the rate of severe eclampsia (23.3% vs. 29.1%; HR, 0.80: 95% confidence interval, 0.70-0.92) and preterm birth (12.2% vs. 16.7%; HR, 0.73: 95% CI, 0.60-0.89).

Across a large array of subgroups, including those with or without diabetes and those treated before or after 14 weeks of gestation, there was a consistent advantage for treatment, even if not statistically different. It is notable that 48% of patients were Black and 35% had a body mass index of at least 40. The active treatment was favored across all groups stratified by these characteristics.

Although the incidences of placental abruption (1.7% on treatment vs. 1.9% without) and fetal or neonatal death (3.5% vs. 4.3%) were lower in the active treatment group, they were uncommon events in both arms of the study. The differences did not reach statistical significance.
 

Maternal morbidity rates lower on treatment

Severe SGA, which was defined as below the 5^th percentile, was also numerically but not significantly higher in the control arm than in the group receiving treatment (5.1% vs. 5.5%), but the incidence of composite adverse maternal events was numerically lower (2.1% vs. 2.8%). The incidences of all components of maternal morbidity, such as maternal death (0.1% vs. 0.2%) pulmonary edema (0.4% vs. 0.9%), heart failure (0.1% vs. 0.1%), and acute kidney injury (0.8% vs. 1.2%), were either lower or the same on active treatment versus no treatment.

According to Dr. Tita, who called CHAP one of the largest and most diverse studies to address the value of treating mild hypertension in pregnancy, the American College of Obstetricians and Gynecologists (ACOG) is evaluating these data for changing their current guidelines for managing hypertension during pregnancy.

“The rate of chronic hypertension during pregnancy has been rising in the United States due to the increase in the average age of pregnant women and the rising rates of obesity,” Dr. Tita commented.

“We definitely needed these data,” said Mary Norine Walsh, MD, medical director, Ascension Saint Vincent Cardiovascular Research Institute, Indianapolis. Not only has the value of treating mild hypertension been unresolved, but Dr. Walsh pointed out that the rates of maternal mortality in the United States are rising and now generally exceed those of many other developed countries.

There are several features in the design of this trial that make the results even more salient to clinical practice, according to Dr. Walsh. This includes the fact that about half of patients enrolled were on Medicaid. As a result, the study confirmed benefit in what Dr. Walsh characterized as a “vulnerable” population.

“We will be busy now to make sure that our [pregnant] patients are achieving these target blood pressures,” Dr. Walsh said. She indicated that CHAP validates the treatment target of 140/90 mm Hg as a standard of care.

The results were published in the New England Journal of Medicine simultaneously with its ACC presentation.

The trial was funded by the National Heart, Lung, and Blood Institute. Dr. Tita reports research grants from Pfizer. Dr. Walsh reports a financial relationship with EBR Systems. Dr. Poppas reports no potential conflicts of interest.

Pregnant women with even mild hypertension should receive blood pressure–lowering medications to reduce the likelihood of adverse outcomes for the mother and the child, according to a large, open-label, randomized trial.

“Treating to the blood pressure goal in this study reduced the risk of adverse events associated with pregnancy but did not impair fetal growth,” Alan T. Tita, MD, PhD, associate dean for Global and Women’s Health, University of Alabama, Birmingham, reported at the annual scientific sessions of the American College of Cardiology.

The question of whether to treat chronic hypertension during pregnancy has been “an international controversy for decades,” said Dr. Tita, who led the investigator-initiated Chronic Hypertension and Pregnancy (CHAP) trial.

For the composite primary outcome of severe preeclampsia, medically indicated preterm birth at less than 35 weeks of gestation, placental abruption, or fetal/neonatal death, the treatment of hypertension versus no treatment showed a relative risk reduction of 18% (30.2% vs. 37%, (hazard ratio, 0.82; P < .001).
 

Small for gestational age is primary safety endpoint

An increase in preeclampsia risk in women whose fetus was small for gestational age (SGA), a theoretical consequence of reductions in arterial pressure, was not seen. The rate of SGA, defined as below the 10^th percentile, was slightly higher in the treatment group (11.2% vs. 10.4%), but the difference did not approach significance (P = 0.76).

By answering this long-pending question, the CHAP data are “practice changing,” declared an ACC-invited commentator, Athena Poppas, MD, chief of cardiology and director of the Lifespan Cardiovascular Institute, Providence, R.I. She agreed that the need for treatment of mild chronic hypertension has been a dilemma for clinicians that is now acceptably resolved.

In this trial, 2,408 pregnant women with chronic mild hypertension defined as a blood pressure of 160/90 mm Hg were randomized to treatment with a goal blood pressure of less than 140/90 mm Hg or no treatment unless the blood pressure rose to at least 160/105. All women had singleton pregnancies. Enrollment before 23 weeks of gestation was required. Severe hypertension (at least 160/105 mm Hg) was an exclusion criterion, as were several comorbidities, such as kidney disease.
 

Combination therapy accepted for <140/90 mm Hg goal

The beta-blocker labetalol or the calcium channel blocker nifedipine as single agents were the preferred antihypertensive medications in the protocol, but other medications were permitted. To reach the blood pressure goal, the single-agent therapy was titrated to the maximum dose before starting a second agent.

After randomization the systolic and diastolic blood pressures fell in both groups, but they fell more and remained consistently lower in the active treatment group, particularly during the first 20 weeks after randomization, according to graphs displayed by Dr. Tita. Over the course of the study, the mean diastolic blood pressures were 129.5 and 132.6 mm Hg in the active treatment and control groups, respectively, while the systolic pressures were 79.1 vs. 81.5 mm Hg.

When the components of the primary outcome were evaluated separately, the greatest advantage of treatment was the reduction in the rate of severe eclampsia (23.3% vs. 29.1%; HR, 0.80: 95% confidence interval, 0.70-0.92) and preterm birth (12.2% vs. 16.7%; HR, 0.73: 95% CI, 0.60-0.89).

Across a large array of subgroups, including those with or without diabetes and those treated before or after 14 weeks of gestation, there was a consistent advantage for treatment, even if not statistically different. It is notable that 48% of patients were Black and 35% had a body mass index of at least 40. The active treatment was favored across all groups stratified by these characteristics.

Although the incidences of placental abruption (1.7% on treatment vs. 1.9% without) and fetal or neonatal death (3.5% vs. 4.3%) were lower in the active treatment group, they were uncommon events in both arms of the study. The differences did not reach statistical significance.
 

Maternal morbidity rates lower on treatment

Severe SGA, which was defined as below the 5^th percentile, was also numerically but not significantly higher in the control arm than in the group receiving treatment (5.1% vs. 5.5%), but the incidence of composite adverse maternal events was numerically lower (2.1% vs. 2.8%). The incidences of all components of maternal morbidity, such as maternal death (0.1% vs. 0.2%) pulmonary edema (0.4% vs. 0.9%), heart failure (0.1% vs. 0.1%), and acute kidney injury (0.8% vs. 1.2%), were either lower or the same on active treatment versus no treatment.

According to Dr. Tita, who called CHAP one of the largest and most diverse studies to address the value of treating mild hypertension in pregnancy, the American College of Obstetricians and Gynecologists (ACOG) is evaluating these data for changing their current guidelines for managing hypertension during pregnancy.

“The rate of chronic hypertension during pregnancy has been rising in the United States due to the increase in the average age of pregnant women and the rising rates of obesity,” Dr. Tita commented.

“We definitely needed these data,” said Mary Norine Walsh, MD, medical director, Ascension Saint Vincent Cardiovascular Research Institute, Indianapolis. Not only has the value of treating mild hypertension been unresolved, but Dr. Walsh pointed out that the rates of maternal mortality in the United States are rising and now generally exceed those of many other developed countries.

There are several features in the design of this trial that make the results even more salient to clinical practice, according to Dr. Walsh. This includes the fact that about half of patients enrolled were on Medicaid. As a result, the study confirmed benefit in what Dr. Walsh characterized as a “vulnerable” population.

“We will be busy now to make sure that our [pregnant] patients are achieving these target blood pressures,” Dr. Walsh said. She indicated that CHAP validates the treatment target of 140/90 mm Hg as a standard of care.

The results were published in the New England Journal of Medicine simultaneously with its ACC presentation.

The trial was funded by the National Heart, Lung, and Blood Institute. Dr. Tita reports research grants from Pfizer. Dr. Walsh reports a financial relationship with EBR Systems. Dr. Poppas reports no potential conflicts of interest.

Pregnant women with even mild hypertension should receive blood pressure–lowering medications to reduce the likelihood of adverse outcomes for the mother and the child, according to a large, open-label, randomized trial.

“Treating to the blood pressure goal in this study reduced the risk of adverse events associated with pregnancy but did not impair fetal growth,” Alan T. Tita, MD, PhD, associate dean for Global and Women’s Health, University of Alabama, Birmingham, reported at the annual scientific sessions of the American College of Cardiology.

The question of whether to treat chronic hypertension during pregnancy has been “an international controversy for decades,” said Dr. Tita, who led the investigator-initiated Chronic Hypertension and Pregnancy (CHAP) trial.

For the composite primary outcome of severe preeclampsia, medically indicated preterm birth at less than 35 weeks of gestation, placental abruption, or fetal/neonatal death, the treatment of hypertension versus no treatment showed a relative risk reduction of 18% (30.2% vs. 37%, (hazard ratio, 0.82; P < .001).
 

Small for gestational age is primary safety endpoint

An increase in preeclampsia risk in women whose fetus was small for gestational age (SGA), a theoretical consequence of reductions in arterial pressure, was not seen. The rate of SGA, defined as below the 10^th percentile, was slightly higher in the treatment group (11.2% vs. 10.4%), but the difference did not approach significance (P = 0.76).

By answering this long-pending question, the CHAP data are “practice changing,” declared an ACC-invited commentator, Athena Poppas, MD, chief of cardiology and director of the Lifespan Cardiovascular Institute, Providence, R.I. She agreed that the need for treatment of mild chronic hypertension has been a dilemma for clinicians that is now acceptably resolved.

In this trial, 2,408 pregnant women with chronic mild hypertension defined as a blood pressure of 160/90 mm Hg were randomized to treatment with a goal blood pressure of less than 140/90 mm Hg or no treatment unless the blood pressure rose to at least 160/105. All women had singleton pregnancies. Enrollment before 23 weeks of gestation was required. Severe hypertension (at least 160/105 mm Hg) was an exclusion criterion, as were several comorbidities, such as kidney disease.
 

Combination therapy accepted for <140/90 mm Hg goal

The beta-blocker labetalol or the calcium channel blocker nifedipine as single agents were the preferred antihypertensive medications in the protocol, but other medications were permitted. To reach the blood pressure goal, the single-agent therapy was titrated to the maximum dose before starting a second agent.

After randomization the systolic and diastolic blood pressures fell in both groups, but they fell more and remained consistently lower in the active treatment group, particularly during the first 20 weeks after randomization, according to graphs displayed by Dr. Tita. Over the course of the study, the mean diastolic blood pressures were 129.5 and 132.6 mm Hg in the active treatment and control groups, respectively, while the systolic pressures were 79.1 vs. 81.5 mm Hg.

When the components of the primary outcome were evaluated separately, the greatest advantage of treatment was the reduction in the rate of severe eclampsia (23.3% vs. 29.1%; HR, 0.80: 95% confidence interval, 0.70-0.92) and preterm birth (12.2% vs. 16.7%; HR, 0.73: 95% CI, 0.60-0.89).

Across a large array of subgroups, including those with or without diabetes and those treated before or after 14 weeks of gestation, there was a consistent advantage for treatment, even if not statistically different. It is notable that 48% of patients were Black and 35% had a body mass index of at least 40. The active treatment was favored across all groups stratified by these characteristics.

Although the incidences of placental abruption (1.7% on treatment vs. 1.9% without) and fetal or neonatal death (3.5% vs. 4.3%) were lower in the active treatment group, they were uncommon events in both arms of the study. The differences did not reach statistical significance.
 

Maternal morbidity rates lower on treatment

Severe SGA, which was defined as below the 5^th percentile, was also numerically but not significantly higher in the control arm than in the group receiving treatment (5.1% vs. 5.5%), but the incidence of composite adverse maternal events was numerically lower (2.1% vs. 2.8%). The incidences of all components of maternal morbidity, such as maternal death (0.1% vs. 0.2%) pulmonary edema (0.4% vs. 0.9%), heart failure (0.1% vs. 0.1%), and acute kidney injury (0.8% vs. 1.2%), were either lower or the same on active treatment versus no treatment.

According to Dr. Tita, who called CHAP one of the largest and most diverse studies to address the value of treating mild hypertension in pregnancy, the American College of Obstetricians and Gynecologists (ACOG) is evaluating these data for changing their current guidelines for managing hypertension during pregnancy.

“The rate of chronic hypertension during pregnancy has been rising in the United States due to the increase in the average age of pregnant women and the rising rates of obesity,” Dr. Tita commented.

“We definitely needed these data,” said Mary Norine Walsh, MD, medical director, Ascension Saint Vincent Cardiovascular Research Institute, Indianapolis. Not only has the value of treating mild hypertension been unresolved, but Dr. Walsh pointed out that the rates of maternal mortality in the United States are rising and now generally exceed those of many other developed countries.

There are several features in the design of this trial that make the results even more salient to clinical practice, according to Dr. Walsh. This includes the fact that about half of patients enrolled were on Medicaid. As a result, the study confirmed benefit in what Dr. Walsh characterized as a “vulnerable” population.

“We will be busy now to make sure that our [pregnant] patients are achieving these target blood pressures,” Dr. Walsh said. She indicated that CHAP validates the treatment target of 140/90 mm Hg as a standard of care.

The results were published in the New England Journal of Medicine simultaneously with its ACC presentation.

The trial was funded by the National Heart, Lung, and Blood Institute. Dr. Tita reports research grants from Pfizer. Dr. Walsh reports a financial relationship with EBR Systems. Dr. Poppas reports no potential conflicts of interest.

Among patients with diabetes, women are just as likely as men to suffer from sexual dysfunction, but their issues are overlooked, with the narrative focusing mainly on the impact of this issue on men, say experts.

Women with diabetes can experience reduced sexual desire, painful sex, reduced lubrication, and sexual distress, increasing the risk of depression, and such issues often go unnoticed despite treatments being available, said Kirsty Winkley, PhD, diabetes nurse and health psychologist, King’s College London.

There is also the “embarrassment factor” on the side of both the health care professional and the patient, she said in a session she chaired at the Diabetes UK Professional Conference 2022. Many women with diabetes “wouldn’t necessarily know” that their sexual dysfunction “is related to their diabetes,” she told this news organization.

For women, sexual health conversations are “often about contraception and pregnancy,” as well as menstrual disorders, genital infections, and hormone replacement therapy. “As health care professionals, you’re trained to focus on those things, and you’re not really considering there might be sexual dysfunction. If women aren’t aware that it’s related to diabetes, you’ve got the perfect situation where it goes under the radar.”

However, cochair Debbie Cooke, PhD, health psychologist at the University of Surrey in Guildford, explained that having psychotherapy embedded within the diabetes team and “integrated throughout the whole service” means that the problem can be identified and treatment offered.

The issue is that such integration is “very uncommon” and access needs to be improved, Dr. Cooke said in an interview.
 

Sexual dysfunction major predictor of depression in women

Jacqueline Fosbury, psychotherapy lead at Diabetes Care for You, Sussex Community NHS Foundation Trust, said that “intimate activity is clearly beneficial for emotional and physical health,” as it is associated with increased oxytocin release, the burning of calories, better immunity, and improved sleep.

Sexual dysfunction is common in people with diabetes, she noted. Poor glycemic control can “damage” blood vessels and nerves, causing reduced blood flow and loss of sensation in sexual organs.

A recent study led by Belgian researchers found that among more than 750 adults with diabetes, 36% of men and 33% of women reported sexual dysfunction.

Sexual dysfunction was more common in women with type 1 diabetes, at 36%, compared with 26% for those with type 2 diabetes. The most commonly reported issues were decreased sexual desire, lubrication problems, orgasmic dysfunction, and pain. Body image problems and fear of hypoglycemia also affect sexuality and intimacy, leading to “sexual distress.”

Moreover, Ms. Fosbury said female sexual dysfunction has been identified as a “major predictor” of depression, which in turn reduces libido.

Treatments for women can include lubricants, local estrogen, and medications that are prescribed off-label, such as sildenafil. The same is true of testosterone therapy, which can be used to boost libido.
 

Couples therapy?

Next, Trudy Hannington, a psychosexual therapist with Leger Clinic, Doncaster, U.K., talked about how to use an integrated approach to address sexuality overall in people with diabetes.

She said this should be seen in a biopsychosocial context, with emphasis on the couple, on sensation and communication, and sexual growth, as well as changes in daily routines.

There should be a move away from “penetrative sex,” Ms. Hannington said, with the goal being “enjoyment, not orgasm.” Pleasure should be facilitated and the opportunities for “performance pressure and/or anxiety” reduced.

She discussed the case of Marie, a 27-year-old woman with type 1 diabetes who had been referred with painful sex and vaginal dryness. Marie had “never experienced orgasm,” despite being in a same-sex relationship with Emily.

Marie’s treatment involved a sexual growth program, to which Emily was invited, as well as recommendations to use lubricants, vibrators, and to try sildenafil.
 

Prioritize women

Ms. Fosbury reiterated that, in men, sexual dysfunction is “readily identified as a complication of diabetes” and is described as “traumatic” and “crucial to well-being.” It is also seen as “easy to treat” with medication, such as that for erectile dysfunction.

It is therefore crucial to talk to women with diabetes about possible sexual dysfunction, and the scene must be set before the appointment to explain that the subject will be broached. In addition, handouts and leaflets should be available for patients in the clinic so they can read about female sexual health and to lower the stigma around discussing it.

“Cultural stereotypes diminish the importance of female sexuality and prevent us from providing equal consideration to the sexual difficulties of our patients,” she concluded.

No funding declared. No relevant financial relationships declared.

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

Among patients with diabetes, women are just as likely as men to suffer from sexual dysfunction, but their issues are overlooked, with the narrative focusing mainly on the impact of this issue on men, say experts.

Women with diabetes can experience reduced sexual desire, painful sex, reduced lubrication, and sexual distress, increasing the risk of depression, and such issues often go unnoticed despite treatments being available, said Kirsty Winkley, PhD, diabetes nurse and health psychologist, King’s College London.

There is also the “embarrassment factor” on the side of both the health care professional and the patient, she said in a session she chaired at the Diabetes UK Professional Conference 2022. Many women with diabetes “wouldn’t necessarily know” that their sexual dysfunction “is related to their diabetes,” she told this news organization.

For women, sexual health conversations are “often about contraception and pregnancy,” as well as menstrual disorders, genital infections, and hormone replacement therapy. “As health care professionals, you’re trained to focus on those things, and you’re not really considering there might be sexual dysfunction. If women aren’t aware that it’s related to diabetes, you’ve got the perfect situation where it goes under the radar.”

However, cochair Debbie Cooke, PhD, health psychologist at the University of Surrey in Guildford, explained that having psychotherapy embedded within the diabetes team and “integrated throughout the whole service” means that the problem can be identified and treatment offered.

The issue is that such integration is “very uncommon” and access needs to be improved, Dr. Cooke said in an interview.
 

Sexual dysfunction major predictor of depression in women

Jacqueline Fosbury, psychotherapy lead at Diabetes Care for You, Sussex Community NHS Foundation Trust, said that “intimate activity is clearly beneficial for emotional and physical health,” as it is associated with increased oxytocin release, the burning of calories, better immunity, and improved sleep.

Sexual dysfunction is common in people with diabetes, she noted. Poor glycemic control can “damage” blood vessels and nerves, causing reduced blood flow and loss of sensation in sexual organs.

A recent study led by Belgian researchers found that among more than 750 adults with diabetes, 36% of men and 33% of women reported sexual dysfunction.

Sexual dysfunction was more common in women with type 1 diabetes, at 36%, compared with 26% for those with type 2 diabetes. The most commonly reported issues were decreased sexual desire, lubrication problems, orgasmic dysfunction, and pain. Body image problems and fear of hypoglycemia also affect sexuality and intimacy, leading to “sexual distress.”

Moreover, Ms. Fosbury said female sexual dysfunction has been identified as a “major predictor” of depression, which in turn reduces libido.

Treatments for women can include lubricants, local estrogen, and medications that are prescribed off-label, such as sildenafil. The same is true of testosterone therapy, which can be used to boost libido.
 

Couples therapy?

Next, Trudy Hannington, a psychosexual therapist with Leger Clinic, Doncaster, U.K., talked about how to use an integrated approach to address sexuality overall in people with diabetes.

She said this should be seen in a biopsychosocial context, with emphasis on the couple, on sensation and communication, and sexual growth, as well as changes in daily routines.

There should be a move away from “penetrative sex,” Ms. Hannington said, with the goal being “enjoyment, not orgasm.” Pleasure should be facilitated and the opportunities for “performance pressure and/or anxiety” reduced.

She discussed the case of Marie, a 27-year-old woman with type 1 diabetes who had been referred with painful sex and vaginal dryness. Marie had “never experienced orgasm,” despite being in a same-sex relationship with Emily.

Marie’s treatment involved a sexual growth program, to which Emily was invited, as well as recommendations to use lubricants, vibrators, and to try sildenafil.
 

Prioritize women

Ms. Fosbury reiterated that, in men, sexual dysfunction is “readily identified as a complication of diabetes” and is described as “traumatic” and “crucial to well-being.” It is also seen as “easy to treat” with medication, such as that for erectile dysfunction.

It is therefore crucial to talk to women with diabetes about possible sexual dysfunction, and the scene must be set before the appointment to explain that the subject will be broached. In addition, handouts and leaflets should be available for patients in the clinic so they can read about female sexual health and to lower the stigma around discussing it.

“Cultural stereotypes diminish the importance of female sexuality and prevent us from providing equal consideration to the sexual difficulties of our patients,” she concluded.

No funding declared. No relevant financial relationships declared.

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

Among patients with diabetes, women are just as likely as men to suffer from sexual dysfunction, but their issues are overlooked, with the narrative focusing mainly on the impact of this issue on men, say experts.

Women with diabetes can experience reduced sexual desire, painful sex, reduced lubrication, and sexual distress, increasing the risk of depression, and such issues often go unnoticed despite treatments being available, said Kirsty Winkley, PhD, diabetes nurse and health psychologist, King’s College London.

There is also the “embarrassment factor” on the side of both the health care professional and the patient, she said in a session she chaired at the Diabetes UK Professional Conference 2022. Many women with diabetes “wouldn’t necessarily know” that their sexual dysfunction “is related to their diabetes,” she told this news organization.

For women, sexual health conversations are “often about contraception and pregnancy,” as well as menstrual disorders, genital infections, and hormone replacement therapy. “As health care professionals, you’re trained to focus on those things, and you’re not really considering there might be sexual dysfunction. If women aren’t aware that it’s related to diabetes, you’ve got the perfect situation where it goes under the radar.”

However, cochair Debbie Cooke, PhD, health psychologist at the University of Surrey in Guildford, explained that having psychotherapy embedded within the diabetes team and “integrated throughout the whole service” means that the problem can be identified and treatment offered.

The issue is that such integration is “very uncommon” and access needs to be improved, Dr. Cooke said in an interview.
 

Sexual dysfunction major predictor of depression in women

Jacqueline Fosbury, psychotherapy lead at Diabetes Care for You, Sussex Community NHS Foundation Trust, said that “intimate activity is clearly beneficial for emotional and physical health,” as it is associated with increased oxytocin release, the burning of calories, better immunity, and improved sleep.

Sexual dysfunction is common in people with diabetes, she noted. Poor glycemic control can “damage” blood vessels and nerves, causing reduced blood flow and loss of sensation in sexual organs.

A recent study led by Belgian researchers found that among more than 750 adults with diabetes, 36% of men and 33% of women reported sexual dysfunction.

Sexual dysfunction was more common in women with type 1 diabetes, at 36%, compared with 26% for those with type 2 diabetes. The most commonly reported issues were decreased sexual desire, lubrication problems, orgasmic dysfunction, and pain. Body image problems and fear of hypoglycemia also affect sexuality and intimacy, leading to “sexual distress.”

Moreover, Ms. Fosbury said female sexual dysfunction has been identified as a “major predictor” of depression, which in turn reduces libido.

Treatments for women can include lubricants, local estrogen, and medications that are prescribed off-label, such as sildenafil. The same is true of testosterone therapy, which can be used to boost libido.
 

Couples therapy?

Next, Trudy Hannington, a psychosexual therapist with Leger Clinic, Doncaster, U.K., talked about how to use an integrated approach to address sexuality overall in people with diabetes.

She said this should be seen in a biopsychosocial context, with emphasis on the couple, on sensation and communication, and sexual growth, as well as changes in daily routines.

There should be a move away from “penetrative sex,” Ms. Hannington said, with the goal being “enjoyment, not orgasm.” Pleasure should be facilitated and the opportunities for “performance pressure and/or anxiety” reduced.

She discussed the case of Marie, a 27-year-old woman with type 1 diabetes who had been referred with painful sex and vaginal dryness. Marie had “never experienced orgasm,” despite being in a same-sex relationship with Emily.

Marie’s treatment involved a sexual growth program, to which Emily was invited, as well as recommendations to use lubricants, vibrators, and to try sildenafil.
 

Prioritize women

Ms. Fosbury reiterated that, in men, sexual dysfunction is “readily identified as a complication of diabetes” and is described as “traumatic” and “crucial to well-being.” It is also seen as “easy to treat” with medication, such as that for erectile dysfunction.

It is therefore crucial to talk to women with diabetes about possible sexual dysfunction, and the scene must be set before the appointment to explain that the subject will be broached. In addition, handouts and leaflets should be available for patients in the clinic so they can read about female sexual health and to lower the stigma around discussing it.

“Cultural stereotypes diminish the importance of female sexuality and prevent us from providing equal consideration to the sexual difficulties of our patients,” she concluded.

No funding declared. No relevant financial relationships declared.

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

Jen Gunter, MD, refuses to stay silent when she sees misleading claims about women’s health products.

In fact, the world’s most famous – and outspoken – ob.gyn. (as described by The Guardian), is on a social media mission to speak up whenever she sees companies or governments “prey on women’s health and vaginal shame.”

With nearly 400,000 followers, Dr. Gunter never shies away from a controversy.

Recently, she railed against vitamin and supplement maker Olly’s vaginal probiotic, taking the company to task for its product premise and objectionable ad copy.

This news organization caught up with the San Francisco–based doctor and author of two books, “The Vagina Bible” and “The Menopause Manifesto.” The following interview has been lightly edited for length and clarity.

Question: So these Olly capsules purport to be “Probiotics for Your Panty Hamster.” What was your reaction to this?

Answer: Seeing the word “panty hamsters” is so egregious. I’m so used to baseline vaginal opportunism, but this was just absolutely egregious and I had to call it out.

Question: What are vaginal probiotics anyway?

Answer: These are one of these big wellness scams where companies try to sell you on somehow hacking your microbiome by taking them. They’re not inexpensive, either, and can range in price from $30 to $150 per month, depending on how bespoke they are. And yet the data isn’t good. There is little to no evidence of the value of these probiotics except to shareholders.

Question: What’s one claim made in the Olly probiotic packaging that bothers you the most?

Answer: The product claims to balance the vaginal pH. To say that is a gross misunderstanding of the vaginal ecosystem. If that tagline is what you’re leading with, what else don’t you know?

Also, if these things worked, we’d recommend them. Vaginitis is complex and often misdiagnosed, and it’s easy for a company to be predatory and swoop in and say they have a product for you.

If I think your product for the vagina is awful and you have not studied it in at least one quality clinical trial (never mind company-funded or not), and your marketing displays a stunning ignorance about vaginal health, don’t approach me about your product. Really.

Question: When there’s a pop culture reference to, say, menstruation, you’re quick to weigh in.

Answer: I saw these viral messages from a boy mom (that’s what she called herself) where she wrote about being disgusted that there were mentions of periods in Turning Red, the animated movie.

Everything is here because of menstruation. If you didn’t menstruate, you wouldn’t have a kid, we wouldn’t have the person who had the intelligence to build the computer you’re spreading this message on. Menstruation is a vital part of human reproduction, and it’s far more complex than people think. For that reason alone, people should know about it.

Question: Do you ever get worried about being so “out there” on social media?

Answer: I have my stalkers I suppose, but the trolls don’t bother me. I don’t care if some whatever art dealer in New York thinks I have mental illness for promoting masks. That’s the best you’ve got? Honestly, this doesn’t even register with me. It’s like throwing a grain of sand at a car.

Question: You also got into an exchange with Dr. Leana Wen, CNN’s medical analyst, about mask wearing.

Answer: She obviously has a different opinion than I do. I think one of the biggest issues in the pandemic is the change in messaging and this idea that somehow people aren’t living their normal lives right now. I was sad to see her promote that concept.

This weekend I went out for lunch, I went furniture shopping, I went to the movies, I took a hike. My family and I wear masks everywhere. I fail to understand how wearing a mask means you’re not living a normal life when it’s clearly linked with the reduced spread of the virus.

Almost everything in medicine is about risk reduction. You can do things to lower your risk of heart disease. It’s not 100% guaranteed, but wouldn’t we want a lower risk of bad things? I’m going to keep wearing a mask forever!

Question: Do you wish more doctors were more vocal like you?

Answer: I wish more doctors would have conversations about health outside of the office in ways they’re comfortable with. Like, you’re at the hairdresser and you share information, or you share information with 15 of your Facebook friends. If you’re a doctor and post an article about COVID-19 and how it impacts the heart, your 15 friends are more likely to read that article than if your friend who’s a lawyer puts that up.

As doctors, I believe we can often influence people in big and small ways.

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

Jen Gunter, MD, refuses to stay silent when she sees misleading claims about women’s health products.

In fact, the world’s most famous – and outspoken – ob.gyn. (as described by The Guardian), is on a social media mission to speak up whenever she sees companies or governments “prey on women’s health and vaginal shame.”

With nearly 400,000 followers, Dr. Gunter never shies away from a controversy.

Recently, she railed against vitamin and supplement maker Olly’s vaginal probiotic, taking the company to task for its product premise and objectionable ad copy.

This news organization caught up with the San Francisco–based doctor and author of two books, “The Vagina Bible” and “The Menopause Manifesto.” The following interview has been lightly edited for length and clarity.

Question: So these Olly capsules purport to be “Probiotics for Your Panty Hamster.” What was your reaction to this?

Answer: Seeing the word “panty hamsters” is so egregious. I’m so used to baseline vaginal opportunism, but this was just absolutely egregious and I had to call it out.

Question: What are vaginal probiotics anyway?

Answer: These are one of these big wellness scams where companies try to sell you on somehow hacking your microbiome by taking them. They’re not inexpensive, either, and can range in price from $30 to $150 per month, depending on how bespoke they are. And yet the data isn’t good. There is little to no evidence of the value of these probiotics except to shareholders.

Question: What’s one claim made in the Olly probiotic packaging that bothers you the most?

Answer: The product claims to balance the vaginal pH. To say that is a gross misunderstanding of the vaginal ecosystem. If that tagline is what you’re leading with, what else don’t you know?

Also, if these things worked, we’d recommend them. Vaginitis is complex and often misdiagnosed, and it’s easy for a company to be predatory and swoop in and say they have a product for you.

If I think your product for the vagina is awful and you have not studied it in at least one quality clinical trial (never mind company-funded or not), and your marketing displays a stunning ignorance about vaginal health, don’t approach me about your product. Really.

Question: When there’s a pop culture reference to, say, menstruation, you’re quick to weigh in.

Answer: I saw these viral messages from a boy mom (that’s what she called herself) where she wrote about being disgusted that there were mentions of periods in Turning Red, the animated movie.

Everything is here because of menstruation. If you didn’t menstruate, you wouldn’t have a kid, we wouldn’t have the person who had the intelligence to build the computer you’re spreading this message on. Menstruation is a vital part of human reproduction, and it’s far more complex than people think. For that reason alone, people should know about it.

Question: Do you ever get worried about being so “out there” on social media?

Answer: I have my stalkers I suppose, but the trolls don’t bother me. I don’t care if some whatever art dealer in New York thinks I have mental illness for promoting masks. That’s the best you’ve got? Honestly, this doesn’t even register with me. It’s like throwing a grain of sand at a car.

Question: You also got into an exchange with Dr. Leana Wen, CNN’s medical analyst, about mask wearing.

Answer: She obviously has a different opinion than I do. I think one of the biggest issues in the pandemic is the change in messaging and this idea that somehow people aren’t living their normal lives right now. I was sad to see her promote that concept.

This weekend I went out for lunch, I went furniture shopping, I went to the movies, I took a hike. My family and I wear masks everywhere. I fail to understand how wearing a mask means you’re not living a normal life when it’s clearly linked with the reduced spread of the virus.

Almost everything in medicine is about risk reduction. You can do things to lower your risk of heart disease. It’s not 100% guaranteed, but wouldn’t we want a lower risk of bad things? I’m going to keep wearing a mask forever!

Question: Do you wish more doctors were more vocal like you?

Answer: I wish more doctors would have conversations about health outside of the office in ways they’re comfortable with. Like, you’re at the hairdresser and you share information, or you share information with 15 of your Facebook friends. If you’re a doctor and post an article about COVID-19 and how it impacts the heart, your 15 friends are more likely to read that article than if your friend who’s a lawyer puts that up.

As doctors, I believe we can often influence people in big and small ways.

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

Jen Gunter, MD, refuses to stay silent when she sees misleading claims about women’s health products.

In fact, the world’s most famous – and outspoken – ob.gyn. (as described by The Guardian), is on a social media mission to speak up whenever she sees companies or governments “prey on women’s health and vaginal shame.”

With nearly 400,000 followers, Dr. Gunter never shies away from a controversy.

Recently, she railed against vitamin and supplement maker Olly’s vaginal probiotic, taking the company to task for its product premise and objectionable ad copy.

This news organization caught up with the San Francisco–based doctor and author of two books, “The Vagina Bible” and “The Menopause Manifesto.” The following interview has been lightly edited for length and clarity.

Question: So these Olly capsules purport to be “Probiotics for Your Panty Hamster.” What was your reaction to this?

Answer: Seeing the word “panty hamsters” is so egregious. I’m so used to baseline vaginal opportunism, but this was just absolutely egregious and I had to call it out.

Question: What are vaginal probiotics anyway?

Answer: These are one of these big wellness scams where companies try to sell you on somehow hacking your microbiome by taking them. They’re not inexpensive, either, and can range in price from $30 to $150 per month, depending on how bespoke they are. And yet the data isn’t good. There is little to no evidence of the value of these probiotics except to shareholders.

Question: What’s one claim made in the Olly probiotic packaging that bothers you the most?

Answer: The product claims to balance the vaginal pH. To say that is a gross misunderstanding of the vaginal ecosystem. If that tagline is what you’re leading with, what else don’t you know?

Also, if these things worked, we’d recommend them. Vaginitis is complex and often misdiagnosed, and it’s easy for a company to be predatory and swoop in and say they have a product for you.

If I think your product for the vagina is awful and you have not studied it in at least one quality clinical trial (never mind company-funded or not), and your marketing displays a stunning ignorance about vaginal health, don’t approach me about your product. Really.

Question: When there’s a pop culture reference to, say, menstruation, you’re quick to weigh in.

Answer: I saw these viral messages from a boy mom (that’s what she called herself) where she wrote about being disgusted that there were mentions of periods in Turning Red, the animated movie.

Everything is here because of menstruation. If you didn’t menstruate, you wouldn’t have a kid, we wouldn’t have the person who had the intelligence to build the computer you’re spreading this message on. Menstruation is a vital part of human reproduction, and it’s far more complex than people think. For that reason alone, people should know about it.

Question: Do you ever get worried about being so “out there” on social media?

Answer: I have my stalkers I suppose, but the trolls don’t bother me. I don’t care if some whatever art dealer in New York thinks I have mental illness for promoting masks. That’s the best you’ve got? Honestly, this doesn’t even register with me. It’s like throwing a grain of sand at a car.

Question: You also got into an exchange with Dr. Leana Wen, CNN’s medical analyst, about mask wearing.

Answer: She obviously has a different opinion than I do. I think one of the biggest issues in the pandemic is the change in messaging and this idea that somehow people aren’t living their normal lives right now. I was sad to see her promote that concept.

This weekend I went out for lunch, I went furniture shopping, I went to the movies, I took a hike. My family and I wear masks everywhere. I fail to understand how wearing a mask means you’re not living a normal life when it’s clearly linked with the reduced spread of the virus.

Almost everything in medicine is about risk reduction. You can do things to lower your risk of heart disease. It’s not 100% guaranteed, but wouldn’t we want a lower risk of bad things? I’m going to keep wearing a mask forever!

Question: Do you wish more doctors were more vocal like you?

Answer: I wish more doctors would have conversations about health outside of the office in ways they’re comfortable with. Like, you’re at the hairdresser and you share information, or you share information with 15 of your Facebook friends. If you’re a doctor and post an article about COVID-19 and how it impacts the heart, your 15 friends are more likely to read that article than if your friend who’s a lawyer puts that up.

As doctors, I believe we can often influence people in big and small ways.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Pediatric care centers are a significant point of access for intimate partner violence referrals, according to data from an IPV prevention program embedded in Boston Children’s Hospital.

The pediatric hospital’s embedded Advocacy for Women and Kids in Emergencies (AWAKE) program found an increase in IPV consults and referrals during the COVID-19 pandemic, particularly for emotional abuse. Despite the shift away from in-office consultations, care was effectively delivered remotely by telehealth.

The findings highlight the importance of pediatric primary care as a point of access for IPV survivor support, the authors concluded.

”Programming for survivors (including patients, family members, and staff) of intimate partner violence is critical in the pediatric hospital setting, especially during the COVID-19 pandemic,” Rehana Rahman, MSW, and colleagues wrote in Pediatrics.

Their results align with other research demonstrating an overall increase in violence against women and girls during the pandemic – a phenomenon the World Health Organization has called the “shadow pandemic.”

The challenges of accessing care during the COVID-19 restrictions demonstrate the utility of telehealth as a modality for providing assessment, support, and referrals, the authors stated.

They pointed to certain advantages in supporting IPV survivors virtually, including the ability to speak alone with the survivor, which is often not possible during in-person visits with children in the room.

Other research has documented that health care delivery via telemedicine, especially video teleconferencing, during the pandemic can be as effective as in-office visits. In fact, care providers may be able to pick up on significant visual cues on video that go unnoticed in the immediacy of the office setting.
 

The study

The researchers examined COVID-19–related variations in consultations and referrals in the 11 months before the COVID-19 pandemic (April 1, 2019, to Feb. 29, 2020) and those following its emergence (April 1, 2020, to Feb. 28, 2021).

Face-to-face consults declined from 28% to 2% (P < .001) after COVID-19 emergence, while total consults increased from 240 to 295 (P < .001), primarily for emotional abuse (from 195 to 264, P = .007).

There were no significant changes in the number of consults for other reasons or in the number of reasons recorded for each consult.

Psychoeducation referrals also rose significantly from 199 to 273 (P < .001), while referrals to community resources decreased significantly from 111 to 95 (P < .001).

Primary care was the only practice setting demonstrating significant differences in the overall number of and specific reasons for consultation, as well as associated referral types before and after COVID emergence.

“We hypothesize that this increase may be attributable to the fact that, although many survivors were at home with partners who use abusive behaviors, obligatory pediatric primary care visits may have been a rare opportunity for them to leave their residence and seek support,” the investigators wrote. “Our data support the importance of a domestic violence program in pediatric hospitals and suggest that such support be available as a standard part of care.”

They further suggested that support and assessment may be effective regardless of whether that care is performed face-to-face or via telehealth.
 

Commentary

An accompanying editorial noted that intimate partner violence affects one in five children and has profound health effects on survivors and their children.

“The health, economic, and social ramifications of the COVID-19 pandemic have created unique challenges for families experiencing IPV, by increasing isolation, decreasing available safe and secure services and spaces (e.g., schools), and compounding preexisting inequities, especially for families from marginalized communities,” wrote Maya Ragavan, MD, MS, MPH, and Elizabeth Miller, MD, PhD, of the department of pediatrics at the University of Pittsburgh.

They stressed that pediatric health care providers should be aware of the emotionally coercive control used by abusive partners during the pandemic, including social isolation, manipulating child custody, and taking stimulus money.

Dr. Ragavan and Dr. Miller agreed with the authors that pediatric health care settings can play an important role in supporting families exposed to intimate partner violence, particularly by developing partnerships with IPV aid agencies.

Many pediatric offices may not have access to a comprehensive service like AWAKE, highlighting the importance of developing partnerships with community-based IPV agencies, which have been working innovatively during the pandemic to support families experiencing IPV. “Pediatric health care providers should work to develop formalized partnerships with IPV agencies to assist with staff training, clinical protocols and policies to address IPV, including survivor-centered approaches to care when IPV is disclosed,” they wrote. “Health care settings must recognize that IPV agencies are integral to the pediatric medical home and essential collaborators in the provision of healing-centered care for IPV survivors and their children.”

Among these, Futures Without Violence, a national violence-prevention advocacy and policy organization, offers recommendations on collaboration via the IPV Health Partners website.

Matthew I. Harris, MD, a pediatric emergency physician at Cohen Children’s Medical Center in New York, concurred that the pediatric care setting can be an access point for IPV referrals. “Whether a child comes into our center with an ear infection or an injury, there’s a standard screening process for safety in the home,” he said in an interview. That standard filtering identifies the presence of smoking, alcohol, guns, and potential abusers. “It’s not uncommon that we discover violence or physical, verbal, or sexual abuse not only toward the child but also another family member, including IPV.”

Children’s hospitals are well positioned to identify at-risk families and refer them to appropriate protective services, Dr. Harris said. “Ultimately, we are charged with the responsibility of ensuring children have a safe home environment and that involves minimizing any harmful impact on other family members, including those exposed to IPV.”

The authors received no funding for this study and reported no competing interests. Dr. Ragavan had no relevant conflicts of interest to disclose. Dr. Miller reported royalties for writing content for UpToDate. Dr. Harris disclosed no competing interests.

This article was updated 3/25/22.

Pediatric care centers are a significant point of access for intimate partner violence referrals, according to data from an IPV prevention program embedded in Boston Children’s Hospital.

The pediatric hospital’s embedded Advocacy for Women and Kids in Emergencies (AWAKE) program found an increase in IPV consults and referrals during the COVID-19 pandemic, particularly for emotional abuse. Despite the shift away from in-office consultations, care was effectively delivered remotely by telehealth.

The findings highlight the importance of pediatric primary care as a point of access for IPV survivor support, the authors concluded.

”Programming for survivors (including patients, family members, and staff) of intimate partner violence is critical in the pediatric hospital setting, especially during the COVID-19 pandemic,” Rehana Rahman, MSW, and colleagues wrote in Pediatrics.

Their results align with other research demonstrating an overall increase in violence against women and girls during the pandemic – a phenomenon the World Health Organization has called the “shadow pandemic.”

The challenges of accessing care during the COVID-19 restrictions demonstrate the utility of telehealth as a modality for providing assessment, support, and referrals, the authors stated.

They pointed to certain advantages in supporting IPV survivors virtually, including the ability to speak alone with the survivor, which is often not possible during in-person visits with children in the room.

Other research has documented that health care delivery via telemedicine, especially video teleconferencing, during the pandemic can be as effective as in-office visits. In fact, care providers may be able to pick up on significant visual cues on video that go unnoticed in the immediacy of the office setting.
 

The study

The researchers examined COVID-19–related variations in consultations and referrals in the 11 months before the COVID-19 pandemic (April 1, 2019, to Feb. 29, 2020) and those following its emergence (April 1, 2020, to Feb. 28, 2021).

Face-to-face consults declined from 28% to 2% (P < .001) after COVID-19 emergence, while total consults increased from 240 to 295 (P < .001), primarily for emotional abuse (from 195 to 264, P = .007).

There were no significant changes in the number of consults for other reasons or in the number of reasons recorded for each consult.

Psychoeducation referrals also rose significantly from 199 to 273 (P < .001), while referrals to community resources decreased significantly from 111 to 95 (P < .001).

Primary care was the only practice setting demonstrating significant differences in the overall number of and specific reasons for consultation, as well as associated referral types before and after COVID emergence.

“We hypothesize that this increase may be attributable to the fact that, although many survivors were at home with partners who use abusive behaviors, obligatory pediatric primary care visits may have been a rare opportunity for them to leave their residence and seek support,” the investigators wrote. “Our data support the importance of a domestic violence program in pediatric hospitals and suggest that such support be available as a standard part of care.”

They further suggested that support and assessment may be effective regardless of whether that care is performed face-to-face or via telehealth.
 

Commentary

An accompanying editorial noted that intimate partner violence affects one in five children and has profound health effects on survivors and their children.

“The health, economic, and social ramifications of the COVID-19 pandemic have created unique challenges for families experiencing IPV, by increasing isolation, decreasing available safe and secure services and spaces (e.g., schools), and compounding preexisting inequities, especially for families from marginalized communities,” wrote Maya Ragavan, MD, MS, MPH, and Elizabeth Miller, MD, PhD, of the department of pediatrics at the University of Pittsburgh.

They stressed that pediatric health care providers should be aware of the emotionally coercive control used by abusive partners during the pandemic, including social isolation, manipulating child custody, and taking stimulus money.

Dr. Ragavan and Dr. Miller agreed with the authors that pediatric health care settings can play an important role in supporting families exposed to intimate partner violence, particularly by developing partnerships with IPV aid agencies.

Many pediatric offices may not have access to a comprehensive service like AWAKE, highlighting the importance of developing partnerships with community-based IPV agencies, which have been working innovatively during the pandemic to support families experiencing IPV. “Pediatric health care providers should work to develop formalized partnerships with IPV agencies to assist with staff training, clinical protocols and policies to address IPV, including survivor-centered approaches to care when IPV is disclosed,” they wrote. “Health care settings must recognize that IPV agencies are integral to the pediatric medical home and essential collaborators in the provision of healing-centered care for IPV survivors and their children.”

Among these, Futures Without Violence, a national violence-prevention advocacy and policy organization, offers recommendations on collaboration via the IPV Health Partners website.

Matthew I. Harris, MD, a pediatric emergency physician at Cohen Children’s Medical Center in New York, concurred that the pediatric care setting can be an access point for IPV referrals. “Whether a child comes into our center with an ear infection or an injury, there’s a standard screening process for safety in the home,” he said in an interview. That standard filtering identifies the presence of smoking, alcohol, guns, and potential abusers. “It’s not uncommon that we discover violence or physical, verbal, or sexual abuse not only toward the child but also another family member, including IPV.”

Children’s hospitals are well positioned to identify at-risk families and refer them to appropriate protective services, Dr. Harris said. “Ultimately, we are charged with the responsibility of ensuring children have a safe home environment and that involves minimizing any harmful impact on other family members, including those exposed to IPV.”

The authors received no funding for this study and reported no competing interests. Dr. Ragavan had no relevant conflicts of interest to disclose. Dr. Miller reported royalties for writing content for UpToDate. Dr. Harris disclosed no competing interests.

This article was updated 3/25/22.

Pediatric care centers are a significant point of access for intimate partner violence referrals, according to data from an IPV prevention program embedded in Boston Children’s Hospital.

The pediatric hospital’s embedded Advocacy for Women and Kids in Emergencies (AWAKE) program found an increase in IPV consults and referrals during the COVID-19 pandemic, particularly for emotional abuse. Despite the shift away from in-office consultations, care was effectively delivered remotely by telehealth.

The findings highlight the importance of pediatric primary care as a point of access for IPV survivor support, the authors concluded.

”Programming for survivors (including patients, family members, and staff) of intimate partner violence is critical in the pediatric hospital setting, especially during the COVID-19 pandemic,” Rehana Rahman, MSW, and colleagues wrote in Pediatrics.

Their results align with other research demonstrating an overall increase in violence against women and girls during the pandemic – a phenomenon the World Health Organization has called the “shadow pandemic.”

The challenges of accessing care during the COVID-19 restrictions demonstrate the utility of telehealth as a modality for providing assessment, support, and referrals, the authors stated.

They pointed to certain advantages in supporting IPV survivors virtually, including the ability to speak alone with the survivor, which is often not possible during in-person visits with children in the room.

Other research has documented that health care delivery via telemedicine, especially video teleconferencing, during the pandemic can be as effective as in-office visits. In fact, care providers may be able to pick up on significant visual cues on video that go unnoticed in the immediacy of the office setting.
 

The study

The researchers examined COVID-19–related variations in consultations and referrals in the 11 months before the COVID-19 pandemic (April 1, 2019, to Feb. 29, 2020) and those following its emergence (April 1, 2020, to Feb. 28, 2021).

Face-to-face consults declined from 28% to 2% (P < .001) after COVID-19 emergence, while total consults increased from 240 to 295 (P < .001), primarily for emotional abuse (from 195 to 264, P = .007).

There were no significant changes in the number of consults for other reasons or in the number of reasons recorded for each consult.

Psychoeducation referrals also rose significantly from 199 to 273 (P < .001), while referrals to community resources decreased significantly from 111 to 95 (P < .001).

Primary care was the only practice setting demonstrating significant differences in the overall number of and specific reasons for consultation, as well as associated referral types before and after COVID emergence.

“We hypothesize that this increase may be attributable to the fact that, although many survivors were at home with partners who use abusive behaviors, obligatory pediatric primary care visits may have been a rare opportunity for them to leave their residence and seek support,” the investigators wrote. “Our data support the importance of a domestic violence program in pediatric hospitals and suggest that such support be available as a standard part of care.”

They further suggested that support and assessment may be effective regardless of whether that care is performed face-to-face or via telehealth.
 

Commentary

An accompanying editorial noted that intimate partner violence affects one in five children and has profound health effects on survivors and their children.

“The health, economic, and social ramifications of the COVID-19 pandemic have created unique challenges for families experiencing IPV, by increasing isolation, decreasing available safe and secure services and spaces (e.g., schools), and compounding preexisting inequities, especially for families from marginalized communities,” wrote Maya Ragavan, MD, MS, MPH, and Elizabeth Miller, MD, PhD, of the department of pediatrics at the University of Pittsburgh.

They stressed that pediatric health care providers should be aware of the emotionally coercive control used by abusive partners during the pandemic, including social isolation, manipulating child custody, and taking stimulus money.

Dr. Ragavan and Dr. Miller agreed with the authors that pediatric health care settings can play an important role in supporting families exposed to intimate partner violence, particularly by developing partnerships with IPV aid agencies.

Many pediatric offices may not have access to a comprehensive service like AWAKE, highlighting the importance of developing partnerships with community-based IPV agencies, which have been working innovatively during the pandemic to support families experiencing IPV. “Pediatric health care providers should work to develop formalized partnerships with IPV agencies to assist with staff training, clinical protocols and policies to address IPV, including survivor-centered approaches to care when IPV is disclosed,” they wrote. “Health care settings must recognize that IPV agencies are integral to the pediatric medical home and essential collaborators in the provision of healing-centered care for IPV survivors and their children.”

Among these, Futures Without Violence, a national violence-prevention advocacy and policy organization, offers recommendations on collaboration via the IPV Health Partners website.

Matthew I. Harris, MD, a pediatric emergency physician at Cohen Children’s Medical Center in New York, concurred that the pediatric care setting can be an access point for IPV referrals. “Whether a child comes into our center with an ear infection or an injury, there’s a standard screening process for safety in the home,” he said in an interview. That standard filtering identifies the presence of smoking, alcohol, guns, and potential abusers. “It’s not uncommon that we discover violence or physical, verbal, or sexual abuse not only toward the child but also another family member, including IPV.”

Children’s hospitals are well positioned to identify at-risk families and refer them to appropriate protective services, Dr. Harris said. “Ultimately, we are charged with the responsibility of ensuring children have a safe home environment and that involves minimizing any harmful impact on other family members, including those exposed to IPV.”

The authors received no funding for this study and reported no competing interests. Dr. Ragavan had no relevant conflicts of interest to disclose. Dr. Miller reported royalties for writing content for UpToDate. Dr. Harris disclosed no competing interests.

This article was updated 3/25/22.

A French research team has developed a microRNA (miRNA) signature for diagnosing endometriosis through a simple saliva test. Its validation in a larger cohort could soon allow doctors to have a cheap, noninvasive, and accurate tool to use in diagnosing a disease that, for the time being, is difficult to identify with any certainty. The researchers suggest that their methodology could be used as a blueprint to investigate other pathologies, both benign and malignant.

ENDO-miRNA study

miRNAs regulate as much as 60% of gene expression at the posttranscriptional level. In the setting of endometriosis, several authors have evaluated the relevance of a blood-based miRNA signature, but the results are discordant because of methodological and control group issues. Other researchers have also sought to develop a miRNA saliva test. A French team wanted to determine whether it was possible to define a saliva-based diagnostic miRNome signature that would allow patients with and without endometriosis to be differentiated and, from there, develop the first specific diagnostic test for the disease.

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

One part of the study involved the identification of a biomarker based on genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing. The second part involved the development of a saliva-based miRNA diagnostic signature according to expression and accuracy profiling using a random forest algorithm.
 

High sensitivity, specificity

Among the 200 patients (mean age, 31 years) enrolled in the study, 76.5% (n = 153) were diagnosed with endometriosis. On average, their pain was statistically more severe than that of the women in the control group. The Visual Analogue Scale (VAS) scores were, respectively: dysmenorrhea 6 versus 5.0 (P < .001), dyspareunia 5.28 versus 4.95 (P < .001), and urinary pain during menstruation 4.35 versus 2.84 (P < .001).

Next-generation sequencing identified an average of 2,561 expressed miRNAs in the saliva samples. The feature selection method generated a subset of 109 miRNAs composing the endometriosis diagnostic signature. Among those miRNAs, 29 were associated with the main signaling pathways of endometriosis: PI3K/AKT, PTEN, Wnt/beta-catenin, HIF1-alpha/NF kappa B, and YAP/TAZ/EGFR.

The accuracy and reproducibility of the signature were tested on several data sets randomly composed of the same proportion of controls and patients with endometriosis. The respective sensitivity, specificity, and area under the curve for the diagnostic miRNA signature were 96.7%, 100%, and 98.3%, respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

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

A French research team has developed a microRNA (miRNA) signature for diagnosing endometriosis through a simple saliva test. Its validation in a larger cohort could soon allow doctors to have a cheap, noninvasive, and accurate tool to use in diagnosing a disease that, for the time being, is difficult to identify with any certainty. The researchers suggest that their methodology could be used as a blueprint to investigate other pathologies, both benign and malignant.

ENDO-miRNA study

miRNAs regulate as much as 60% of gene expression at the posttranscriptional level. In the setting of endometriosis, several authors have evaluated the relevance of a blood-based miRNA signature, but the results are discordant because of methodological and control group issues. Other researchers have also sought to develop a miRNA saliva test. A French team wanted to determine whether it was possible to define a saliva-based diagnostic miRNome signature that would allow patients with and without endometriosis to be differentiated and, from there, develop the first specific diagnostic test for the disease.

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

One part of the study involved the identification of a biomarker based on genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing. The second part involved the development of a saliva-based miRNA diagnostic signature according to expression and accuracy profiling using a random forest algorithm.
 

High sensitivity, specificity

Among the 200 patients (mean age, 31 years) enrolled in the study, 76.5% (n = 153) were diagnosed with endometriosis. On average, their pain was statistically more severe than that of the women in the control group. The Visual Analogue Scale (VAS) scores were, respectively: dysmenorrhea 6 versus 5.0 (P < .001), dyspareunia 5.28 versus 4.95 (P < .001), and urinary pain during menstruation 4.35 versus 2.84 (P < .001).

Next-generation sequencing identified an average of 2,561 expressed miRNAs in the saliva samples. The feature selection method generated a subset of 109 miRNAs composing the endometriosis diagnostic signature. Among those miRNAs, 29 were associated with the main signaling pathways of endometriosis: PI3K/AKT, PTEN, Wnt/beta-catenin, HIF1-alpha/NF kappa B, and YAP/TAZ/EGFR.

The accuracy and reproducibility of the signature were tested on several data sets randomly composed of the same proportion of controls and patients with endometriosis. The respective sensitivity, specificity, and area under the curve for the diagnostic miRNA signature were 96.7%, 100%, and 98.3%, respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

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

A French research team has developed a microRNA (miRNA) signature for diagnosing endometriosis through a simple saliva test. Its validation in a larger cohort could soon allow doctors to have a cheap, noninvasive, and accurate tool to use in diagnosing a disease that, for the time being, is difficult to identify with any certainty. The researchers suggest that their methodology could be used as a blueprint to investigate other pathologies, both benign and malignant.

ENDO-miRNA study

miRNAs regulate as much as 60% of gene expression at the posttranscriptional level. In the setting of endometriosis, several authors have evaluated the relevance of a blood-based miRNA signature, but the results are discordant because of methodological and control group issues. Other researchers have also sought to develop a miRNA saliva test. A French team wanted to determine whether it was possible to define a saliva-based diagnostic miRNome signature that would allow patients with and without endometriosis to be differentiated and, from there, develop the first specific diagnostic test for the disease.

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

One part of the study involved the identification of a biomarker based on genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing. The second part involved the development of a saliva-based miRNA diagnostic signature according to expression and accuracy profiling using a random forest algorithm.
 

High sensitivity, specificity

Among the 200 patients (mean age, 31 years) enrolled in the study, 76.5% (n = 153) were diagnosed with endometriosis. On average, their pain was statistically more severe than that of the women in the control group. The Visual Analogue Scale (VAS) scores were, respectively: dysmenorrhea 6 versus 5.0 (P < .001), dyspareunia 5.28 versus 4.95 (P < .001), and urinary pain during menstruation 4.35 versus 2.84 (P < .001).

Next-generation sequencing identified an average of 2,561 expressed miRNAs in the saliva samples. The feature selection method generated a subset of 109 miRNAs composing the endometriosis diagnostic signature. Among those miRNAs, 29 were associated with the main signaling pathways of endometriosis: PI3K/AKT, PTEN, Wnt/beta-catenin, HIF1-alpha/NF kappa B, and YAP/TAZ/EGFR.

The accuracy and reproducibility of the signature were tested on several data sets randomly composed of the same proportion of controls and patients with endometriosis. The respective sensitivity, specificity, and area under the curve for the diagnostic miRNA signature were 96.7%, 100%, and 98.3%, respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

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

A small, and likely decreasing, number of health care providers in the United States perform abortions, and there is a risk that the count will be shrinking in the face of legislative attacks on the service, researchers have found.

Until now, producing an accurate count of abortion service providers in the United States has been difficult, leaving researchers to rely on indirect assessments of abortion clinics rather than counts of physicians who perform the procedure.

But the authors of a research letter published in JAMA Internal Medicine have come up with a number: Roughly 3,550 clinicians provide procedural and medication abortions, while 22,001 manage pregnancy loss with the same procedures and medications. More than half of all abortions in the United States now are achieved by medication.

The small number of providers is a cause for concern as a growing number of states move to restrict access to abortions, experts say.

“Abortions are only available if clinicians provide them,” said Julia Strasser, DrPH, MPH, senior research scientist at the George Washington University Milken Institute School of Public Health, Washington, D.C., who led the research. “This study finds that a variety of clinician types provide abortion care. But the number of abortion providers is low, and increasing restrictions will only make this worse.”

For their census, Dr. Strasser and her colleagues evaluated medical claims covering a full year from a private data company. They focused on two sets of services: medications (misoprostol and mifepristone) used in abortion care and pregnancy loss and procedures such as dilation and curettage and dilation and evacuation. Services were categorized as induced abortion or management by pregnancy loss on the basis of medical coding.

The researchers found that there were 3,550 abortion providers and 22,001 clinicians who managed pregnancy loss. Of those who induced abortions, 88% were physicians and 12% were advanced practice clinicians.

The clinicians who most frequently provided induced abortions were ob/gyns (72%), followed by family physicians (9%), advanced practice registered nurses (8%), and nurse midwives (3%). Several other specialists performed about 1% of abortions each.

Dr. Strasser said that 3,550 is an undercount because many providers do offer abortions but cannot or do not bill for them. Even so, the number likely will fall because fewer medical students are being trained for abortion procedures, according to Kaiser Health News.

Despite recommendations from the American College of Obstetricians and Gynecologists for standardized training on abortion care during medical residency, the number of programs that prohibit that training has surged in recent years, the report notes.
 

Restrictions looming

Compounding the problem, the researchers say, is the recent spate of state-level legislation regarding access to abortion. The U.S. Supreme Court is due to rule soon on a Mississippi law banning all abortions over 15 weeks’ gestational age, except in medical emergencies and in the case of severe fetal abnormalities.

Last May, Texas passed a law outlawing termination of pregnancy after 6 weeks of gestation – before many women know they’re pregnant. The law created a bounty system that permits essentially anyone in the United States to sue a woman in the state who seeks an abortion outside the law or anyone who assists her – including health care professionals. The Supreme Court in December refused to overturn the law – which reportedly has triggered a surge in women seeking abortion services in neighboring Oklahoma.

The legal environment is greatly increasing the risk that more clinicians will drop out of the workforce, Dr. Strasser told this news organization.

“As this happens, abortion care will undoubtedly become harder to access, especially for vulnerable populations,” she said. “Patients will have to travel farther, pay more money, or forgo necessary care.”

Another major variable is insurance coverage, the researchers found. Abortion coverage is highly restricted under private insurance and Medicaid, they note. Beyond increasingly restrictive payment issues, policies seen as punitive toward clinicians may cause many to stop offering medication and procedural services, Dr. Strasser said.

“The national political climate will likely see more barriers and less access to care in the coming months and years,” she told this news organization. “However, some states are taking concrete steps to protect abortion access for their residents and for others out of state. In supportive environments like these, enhanced training, expanded scope of practice, and improved reimbursement policies can increase access.”

If the Supreme Court overturns Roe v. Wade, Kaiser Health News reported, 26 states would likely ban abortion, triggering a flood of patients to states where the procedure remains more widely available.

According to the Center for Reproductive Rights, states that have expanded access are Washington, Oregon, California, New York, Vermont, Connecticut, and New Jersey. Another 12 states offer protected access, in which abortion is likely to remain legal even if Roe v. Wade is overturned, since in many of them, abortion is protected under their state constitutions.
 

Pivot to telehealth?

Another study, published in the same issue of JAMA Internal Medicine, evaluated health outcomes for 3,779 women. That study found that eligibility screening for medical abortions by history alone, without pelvic examination or ultrasonography, was safe and effective. That study found that medications were either dispensed in person or through the mail.

Taken together, the two studies suggest that more abortion services may shift toward telehealth, which could expand the number of health care professionals performing such services. Providers could include nurse practitioners, midwives, and physician assistants, said Melissa Grant, chief operating officer of carafem, a reproductive health and abortion service provider.

The service, which has offices in Atlanta, Chicago, Nashville, and Washington, D.C., has found that many patients prefer online appointments, especially if they live in rural areas, Ms. Grant said. The pandemic created a push toward online services.

“Even before the current breadth of restrictive legislation, we were seeing in increase because of COVID,” she said. “Most likely, abortion providers will continue to be pushed out of the profession, so having an option that’s widely available no matter where you live is essential. The United States is moving toward a system where the ZIP code you live in will foretell what care you get. That’s chilling.”

Those who currently provide abortion care have two advantages over what was available previously, Ms. Grant said. First, medical abortion is much more common, and data show that it is safe and effective for most pregnant people, as long as they undergo a health screening. Second, the boom in telehealth during the pandemic means providers are much more experienced in this type of service than before.

As more services such as carafem crop up, costs will drop, since a telehealth clinic – even one that uses health care professionals – has fewer expenses, such as for rent and equipment, than a physical facility.

“Because of the stigma around abortion, this is not likely to prompt a big rush of start-ups, but I do think we’re going to see a shake-up in the way services are being offered, and both patients and providers will likely turn toward technology,” Ms. Grant said. “An environment like this will require flexibility, innovation, and some real grit. We may take some time to get there, but it’s possible this moment is a pivot point in how abortion care is provided.”

Some of the researchers received grants from the Susan T. Buffett Foundation.

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

A small, and likely decreasing, number of health care providers in the United States perform abortions, and there is a risk that the count will be shrinking in the face of legislative attacks on the service, researchers have found.

Until now, producing an accurate count of abortion service providers in the United States has been difficult, leaving researchers to rely on indirect assessments of abortion clinics rather than counts of physicians who perform the procedure.

But the authors of a research letter published in JAMA Internal Medicine have come up with a number: Roughly 3,550 clinicians provide procedural and medication abortions, while 22,001 manage pregnancy loss with the same procedures and medications. More than half of all abortions in the United States now are achieved by medication.

The small number of providers is a cause for concern as a growing number of states move to restrict access to abortions, experts say.

“Abortions are only available if clinicians provide them,” said Julia Strasser, DrPH, MPH, senior research scientist at the George Washington University Milken Institute School of Public Health, Washington, D.C., who led the research. “This study finds that a variety of clinician types provide abortion care. But the number of abortion providers is low, and increasing restrictions will only make this worse.”

For their census, Dr. Strasser and her colleagues evaluated medical claims covering a full year from a private data company. They focused on two sets of services: medications (misoprostol and mifepristone) used in abortion care and pregnancy loss and procedures such as dilation and curettage and dilation and evacuation. Services were categorized as induced abortion or management by pregnancy loss on the basis of medical coding.

The researchers found that there were 3,550 abortion providers and 22,001 clinicians who managed pregnancy loss. Of those who induced abortions, 88% were physicians and 12% were advanced practice clinicians.

The clinicians who most frequently provided induced abortions were ob/gyns (72%), followed by family physicians (9%), advanced practice registered nurses (8%), and nurse midwives (3%). Several other specialists performed about 1% of abortions each.

Dr. Strasser said that 3,550 is an undercount because many providers do offer abortions but cannot or do not bill for them. Even so, the number likely will fall because fewer medical students are being trained for abortion procedures, according to Kaiser Health News.

Despite recommendations from the American College of Obstetricians and Gynecologists for standardized training on abortion care during medical residency, the number of programs that prohibit that training has surged in recent years, the report notes.
 

Restrictions looming

Compounding the problem, the researchers say, is the recent spate of state-level legislation regarding access to abortion. The U.S. Supreme Court is due to rule soon on a Mississippi law banning all abortions over 15 weeks’ gestational age, except in medical emergencies and in the case of severe fetal abnormalities.

Last May, Texas passed a law outlawing termination of pregnancy after 6 weeks of gestation – before many women know they’re pregnant. The law created a bounty system that permits essentially anyone in the United States to sue a woman in the state who seeks an abortion outside the law or anyone who assists her – including health care professionals. The Supreme Court in December refused to overturn the law – which reportedly has triggered a surge in women seeking abortion services in neighboring Oklahoma.

The legal environment is greatly increasing the risk that more clinicians will drop out of the workforce, Dr. Strasser told this news organization.

“As this happens, abortion care will undoubtedly become harder to access, especially for vulnerable populations,” she said. “Patients will have to travel farther, pay more money, or forgo necessary care.”

Another major variable is insurance coverage, the researchers found. Abortion coverage is highly restricted under private insurance and Medicaid, they note. Beyond increasingly restrictive payment issues, policies seen as punitive toward clinicians may cause many to stop offering medication and procedural services, Dr. Strasser said.

“The national political climate will likely see more barriers and less access to care in the coming months and years,” she told this news organization. “However, some states are taking concrete steps to protect abortion access for their residents and for others out of state. In supportive environments like these, enhanced training, expanded scope of practice, and improved reimbursement policies can increase access.”

If the Supreme Court overturns Roe v. Wade, Kaiser Health News reported, 26 states would likely ban abortion, triggering a flood of patients to states where the procedure remains more widely available.

According to the Center for Reproductive Rights, states that have expanded access are Washington, Oregon, California, New York, Vermont, Connecticut, and New Jersey. Another 12 states offer protected access, in which abortion is likely to remain legal even if Roe v. Wade is overturned, since in many of them, abortion is protected under their state constitutions.
 

Pivot to telehealth?

Another study, published in the same issue of JAMA Internal Medicine, evaluated health outcomes for 3,779 women. That study found that eligibility screening for medical abortions by history alone, without pelvic examination or ultrasonography, was safe and effective. That study found that medications were either dispensed in person or through the mail.

Taken together, the two studies suggest that more abortion services may shift toward telehealth, which could expand the number of health care professionals performing such services. Providers could include nurse practitioners, midwives, and physician assistants, said Melissa Grant, chief operating officer of carafem, a reproductive health and abortion service provider.

The service, which has offices in Atlanta, Chicago, Nashville, and Washington, D.C., has found that many patients prefer online appointments, especially if they live in rural areas, Ms. Grant said. The pandemic created a push toward online services.

“Even before the current breadth of restrictive legislation, we were seeing in increase because of COVID,” she said. “Most likely, abortion providers will continue to be pushed out of the profession, so having an option that’s widely available no matter where you live is essential. The United States is moving toward a system where the ZIP code you live in will foretell what care you get. That’s chilling.”

Those who currently provide abortion care have two advantages over what was available previously, Ms. Grant said. First, medical abortion is much more common, and data show that it is safe and effective for most pregnant people, as long as they undergo a health screening. Second, the boom in telehealth during the pandemic means providers are much more experienced in this type of service than before.

As more services such as carafem crop up, costs will drop, since a telehealth clinic – even one that uses health care professionals – has fewer expenses, such as for rent and equipment, than a physical facility.

“Because of the stigma around abortion, this is not likely to prompt a big rush of start-ups, but I do think we’re going to see a shake-up in the way services are being offered, and both patients and providers will likely turn toward technology,” Ms. Grant said. “An environment like this will require flexibility, innovation, and some real grit. We may take some time to get there, but it’s possible this moment is a pivot point in how abortion care is provided.”

Some of the researchers received grants from the Susan T. Buffett Foundation.

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

A small, and likely decreasing, number of health care providers in the United States perform abortions, and there is a risk that the count will be shrinking in the face of legislative attacks on the service, researchers have found.

Until now, producing an accurate count of abortion service providers in the United States has been difficult, leaving researchers to rely on indirect assessments of abortion clinics rather than counts of physicians who perform the procedure.

But the authors of a research letter published in JAMA Internal Medicine have come up with a number: Roughly 3,550 clinicians provide procedural and medication abortions, while 22,001 manage pregnancy loss with the same procedures and medications. More than half of all abortions in the United States now are achieved by medication.

The small number of providers is a cause for concern as a growing number of states move to restrict access to abortions, experts say.

“Abortions are only available if clinicians provide them,” said Julia Strasser, DrPH, MPH, senior research scientist at the George Washington University Milken Institute School of Public Health, Washington, D.C., who led the research. “This study finds that a variety of clinician types provide abortion care. But the number of abortion providers is low, and increasing restrictions will only make this worse.”

For their census, Dr. Strasser and her colleagues evaluated medical claims covering a full year from a private data company. They focused on two sets of services: medications (misoprostol and mifepristone) used in abortion care and pregnancy loss and procedures such as dilation and curettage and dilation and evacuation. Services were categorized as induced abortion or management by pregnancy loss on the basis of medical coding.

The researchers found that there were 3,550 abortion providers and 22,001 clinicians who managed pregnancy loss. Of those who induced abortions, 88% were physicians and 12% were advanced practice clinicians.

The clinicians who most frequently provided induced abortions were ob/gyns (72%), followed by family physicians (9%), advanced practice registered nurses (8%), and nurse midwives (3%). Several other specialists performed about 1% of abortions each.

Dr. Strasser said that 3,550 is an undercount because many providers do offer abortions but cannot or do not bill for them. Even so, the number likely will fall because fewer medical students are being trained for abortion procedures, according to Kaiser Health News.

Despite recommendations from the American College of Obstetricians and Gynecologists for standardized training on abortion care during medical residency, the number of programs that prohibit that training has surged in recent years, the report notes.
 

Restrictions looming

Compounding the problem, the researchers say, is the recent spate of state-level legislation regarding access to abortion. The U.S. Supreme Court is due to rule soon on a Mississippi law banning all abortions over 15 weeks’ gestational age, except in medical emergencies and in the case of severe fetal abnormalities.

Last May, Texas passed a law outlawing termination of pregnancy after 6 weeks of gestation – before many women know they’re pregnant. The law created a bounty system that permits essentially anyone in the United States to sue a woman in the state who seeks an abortion outside the law or anyone who assists her – including health care professionals. The Supreme Court in December refused to overturn the law – which reportedly has triggered a surge in women seeking abortion services in neighboring Oklahoma.

The legal environment is greatly increasing the risk that more clinicians will drop out of the workforce, Dr. Strasser told this news organization.

“As this happens, abortion care will undoubtedly become harder to access, especially for vulnerable populations,” she said. “Patients will have to travel farther, pay more money, or forgo necessary care.”

Another major variable is insurance coverage, the researchers found. Abortion coverage is highly restricted under private insurance and Medicaid, they note. Beyond increasingly restrictive payment issues, policies seen as punitive toward clinicians may cause many to stop offering medication and procedural services, Dr. Strasser said.

“The national political climate will likely see more barriers and less access to care in the coming months and years,” she told this news organization. “However, some states are taking concrete steps to protect abortion access for their residents and for others out of state. In supportive environments like these, enhanced training, expanded scope of practice, and improved reimbursement policies can increase access.”

If the Supreme Court overturns Roe v. Wade, Kaiser Health News reported, 26 states would likely ban abortion, triggering a flood of patients to states where the procedure remains more widely available.

According to the Center for Reproductive Rights, states that have expanded access are Washington, Oregon, California, New York, Vermont, Connecticut, and New Jersey. Another 12 states offer protected access, in which abortion is likely to remain legal even if Roe v. Wade is overturned, since in many of them, abortion is protected under their state constitutions.
 

Pivot to telehealth?

Another study, published in the same issue of JAMA Internal Medicine, evaluated health outcomes for 3,779 women. That study found that eligibility screening for medical abortions by history alone, without pelvic examination or ultrasonography, was safe and effective. That study found that medications were either dispensed in person or through the mail.

Taken together, the two studies suggest that more abortion services may shift toward telehealth, which could expand the number of health care professionals performing such services. Providers could include nurse practitioners, midwives, and physician assistants, said Melissa Grant, chief operating officer of carafem, a reproductive health and abortion service provider.

The service, which has offices in Atlanta, Chicago, Nashville, and Washington, D.C., has found that many patients prefer online appointments, especially if they live in rural areas, Ms. Grant said. The pandemic created a push toward online services.

“Even before the current breadth of restrictive legislation, we were seeing in increase because of COVID,” she said. “Most likely, abortion providers will continue to be pushed out of the profession, so having an option that’s widely available no matter where you live is essential. The United States is moving toward a system where the ZIP code you live in will foretell what care you get. That’s chilling.”

Those who currently provide abortion care have two advantages over what was available previously, Ms. Grant said. First, medical abortion is much more common, and data show that it is safe and effective for most pregnant people, as long as they undergo a health screening. Second, the boom in telehealth during the pandemic means providers are much more experienced in this type of service than before.

As more services such as carafem crop up, costs will drop, since a telehealth clinic – even one that uses health care professionals – has fewer expenses, such as for rent and equipment, than a physical facility.

“Because of the stigma around abortion, this is not likely to prompt a big rush of start-ups, but I do think we’re going to see a shake-up in the way services are being offered, and both patients and providers will likely turn toward technology,” Ms. Grant said. “An environment like this will require flexibility, innovation, and some real grit. We may take some time to get there, but it’s possible this moment is a pivot point in how abortion care is provided.”

Some of the researchers received grants from the Susan T. Buffett Foundation.

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

As family medicine physicians it is our duty to help facilitate patients’ health care based on what is in patients’ best interests and aligns with the goals they have for their lives.

I am aware of how intersecting social, economic, familial, and environmental factors influence what is best for patient’s lives, and I consider having this awareness to be part of being a family medicine physician.

People being able to make choices about their reproductive health and their reproductive futures without unnecessary and harmful barriers is a part of a person’s overall health that family medicine physicians should recognize and prioritize. Helping people achieve their reproductive health care goals includes helping patients access abortion care if that is the care that they decide that they need.

According to the Guttmacher Institute, 2021 was “the worst year for abortion rights in almost half a century” as 108 abortion restrictions were enacted throughout the country. The most damaging restriction was introduced in Texas in the fall of 2021 called SB8, which has virtually stopped all abortion care in person for any person with a pregnancy greater than 6 weeks’ gestation. Now, in 2022 we are seeing several other states, including Idaho and Oklahoma, set to pass similar laws that will essentially halt most abortion care in the clinical setting in those states.

Abortion access had already been a problem in much of the country prior to 2021 because of burdensome and not medically necessary restrictions. Based on current political trends we are getting to a place where it is not hard to imagine that up to half of the states in this country will not allow their communities to access abortion care in the clinical setting at all in the very near future. This is not reproductive freedom, and I am outraged that people are being forced to travel hundreds of miles for their abortion care, forced to continue pregnancies that they don’t want, or forced to find other ways to obtain medication abortion pills.

While obtaining medication abortion pills online and managing the abortion process at home is safe and recognized as safe by the World Health Organization, no one should be forced to utilize a certain type of care based on their state of residence, in my opinion.

Providing evidence-based medicine to patients is ‘my duty’

Abortion care is health care and is primary care. One in four women will have an abortion by the age of 45, and we know that transgender, nonbinary, and gender-expansive people also have abortions. That means on any given day as family medicine physicians we are likely taking care of more than one person who has had an abortion, will have an abortion, and/or is considering an abortion. Therefore, all family medicine physicians need to be prepared to counsel patients about all of their pregnancy options, answer questions about pregnancy and abortion, and help people get the compassionate care that they deserve.

Our patients turn to us as trusted sources of information. When they reach out to us, I consider providing evidence-based medicine to patients – that includes factual information about abortion care if and when our patients need it – to be my duty as a family medicine physician.
 

Resources on abortion care for family medicine physicians

For family medicine physicians who did not have adequate exposure to abortion care during residency, there are many evidence-based resources to review in order to become more knowledgeable in abortion care.

In many areas of medicine, we have to continue to learn and seek out references, and abortion care is no different. One could argue that understanding abortion care and providing patients with factual information about their options and abortion care is even more important because of stigma surrounding abortion care and the rampant lies about abortion care that are easily accessible and that even other medical professionals and politicians spread. There are even fake clinics, often called “crisis pregnancy centers”, that intimidate, lie about abortion, and coerce patients to make decisions that are against their desires. Thus, being that trusted source of factual information about abortion care is even more important in the face of so many lies.

There are several organizations that are dedicated to education surrounding abortion care, in particular within the primary care setting. The Reproductive Health Access Project (RHAP), Reproductive Health Education in Family Medicine (RHEDI), and Training in Early Abortion for Comprehensive Healthcare (TEACH) all provide free resources on abortion care, how to incorporate abortion care into primary care, and how to teach medical students and residents about abortion care.

In addition, the National Network of Abortion Funds connects people to community-led organizations that provide assistance related to direct financial and logistical support for obtaining abortion care. I believe it is critical that we familiarize ourselves with our local abortion funds and share what we learn about these resources with our patients.

As abortion access continues to be further stripped away from many people that we take care of, I think standing up for what is right and what is our duty as physicians becomes more important. That duty is to provide our patients with evidence-based medicine and compassionate care so that our communities can obtain reproductive health outcomes and freedom that are best for their lives.
 

Dr. Lockley is a family physician currently living in Harlem, N.Y., and a member of the editorial advisory board of Family Practice News. She currently works for Public Health Solutions’ Sexual and Reproductive Health Centers in Brooklyn, providing primary care and reproductive health care services there, and as an abortion provider throughout the New York region. She completed both medical school and residency in Philadelphia and then did a fellowship in reproductive health care and advocacy through the Family Health Center of Harlem and the Reproductive Health Access Project. She can be reached at [email protected].

As family medicine physicians it is our duty to help facilitate patients’ health care based on what is in patients’ best interests and aligns with the goals they have for their lives.

I am aware of how intersecting social, economic, familial, and environmental factors influence what is best for patient’s lives, and I consider having this awareness to be part of being a family medicine physician.

People being able to make choices about their reproductive health and their reproductive futures without unnecessary and harmful barriers is a part of a person’s overall health that family medicine physicians should recognize and prioritize. Helping people achieve their reproductive health care goals includes helping patients access abortion care if that is the care that they decide that they need.

According to the Guttmacher Institute, 2021 was “the worst year for abortion rights in almost half a century” as 108 abortion restrictions were enacted throughout the country. The most damaging restriction was introduced in Texas in the fall of 2021 called SB8, which has virtually stopped all abortion care in person for any person with a pregnancy greater than 6 weeks’ gestation. Now, in 2022 we are seeing several other states, including Idaho and Oklahoma, set to pass similar laws that will essentially halt most abortion care in the clinical setting in those states.

Abortion access had already been a problem in much of the country prior to 2021 because of burdensome and not medically necessary restrictions. Based on current political trends we are getting to a place where it is not hard to imagine that up to half of the states in this country will not allow their communities to access abortion care in the clinical setting at all in the very near future. This is not reproductive freedom, and I am outraged that people are being forced to travel hundreds of miles for their abortion care, forced to continue pregnancies that they don’t want, or forced to find other ways to obtain medication abortion pills.

While obtaining medication abortion pills online and managing the abortion process at home is safe and recognized as safe by the World Health Organization, no one should be forced to utilize a certain type of care based on their state of residence, in my opinion.

Providing evidence-based medicine to patients is ‘my duty’

Abortion care is health care and is primary care. One in four women will have an abortion by the age of 45, and we know that transgender, nonbinary, and gender-expansive people also have abortions. That means on any given day as family medicine physicians we are likely taking care of more than one person who has had an abortion, will have an abortion, and/or is considering an abortion. Therefore, all family medicine physicians need to be prepared to counsel patients about all of their pregnancy options, answer questions about pregnancy and abortion, and help people get the compassionate care that they deserve.

Our patients turn to us as trusted sources of information. When they reach out to us, I consider providing evidence-based medicine to patients – that includes factual information about abortion care if and when our patients need it – to be my duty as a family medicine physician.
 

Resources on abortion care for family medicine physicians

For family medicine physicians who did not have adequate exposure to abortion care during residency, there are many evidence-based resources to review in order to become more knowledgeable in abortion care.

In many areas of medicine, we have to continue to learn and seek out references, and abortion care is no different. One could argue that understanding abortion care and providing patients with factual information about their options and abortion care is even more important because of stigma surrounding abortion care and the rampant lies about abortion care that are easily accessible and that even other medical professionals and politicians spread. There are even fake clinics, often called “crisis pregnancy centers”, that intimidate, lie about abortion, and coerce patients to make decisions that are against their desires. Thus, being that trusted source of factual information about abortion care is even more important in the face of so many lies.

There are several organizations that are dedicated to education surrounding abortion care, in particular within the primary care setting. The Reproductive Health Access Project (RHAP), Reproductive Health Education in Family Medicine (RHEDI), and Training in Early Abortion for Comprehensive Healthcare (TEACH) all provide free resources on abortion care, how to incorporate abortion care into primary care, and how to teach medical students and residents about abortion care.

In addition, the National Network of Abortion Funds connects people to community-led organizations that provide assistance related to direct financial and logistical support for obtaining abortion care. I believe it is critical that we familiarize ourselves with our local abortion funds and share what we learn about these resources with our patients.

As abortion access continues to be further stripped away from many people that we take care of, I think standing up for what is right and what is our duty as physicians becomes more important. That duty is to provide our patients with evidence-based medicine and compassionate care so that our communities can obtain reproductive health outcomes and freedom that are best for their lives.
 

Dr. Lockley is a family physician currently living in Harlem, N.Y., and a member of the editorial advisory board of Family Practice News. She currently works for Public Health Solutions’ Sexual and Reproductive Health Centers in Brooklyn, providing primary care and reproductive health care services there, and as an abortion provider throughout the New York region. She completed both medical school and residency in Philadelphia and then did a fellowship in reproductive health care and advocacy through the Family Health Center of Harlem and the Reproductive Health Access Project. She can be reached at [email protected].

As family medicine physicians it is our duty to help facilitate patients’ health care based on what is in patients’ best interests and aligns with the goals they have for their lives.

I am aware of how intersecting social, economic, familial, and environmental factors influence what is best for patient’s lives, and I consider having this awareness to be part of being a family medicine physician.

People being able to make choices about their reproductive health and their reproductive futures without unnecessary and harmful barriers is a part of a person’s overall health that family medicine physicians should recognize and prioritize. Helping people achieve their reproductive health care goals includes helping patients access abortion care if that is the care that they decide that they need.

According to the Guttmacher Institute, 2021 was “the worst year for abortion rights in almost half a century” as 108 abortion restrictions were enacted throughout the country. The most damaging restriction was introduced in Texas in the fall of 2021 called SB8, which has virtually stopped all abortion care in person for any person with a pregnancy greater than 6 weeks’ gestation. Now, in 2022 we are seeing several other states, including Idaho and Oklahoma, set to pass similar laws that will essentially halt most abortion care in the clinical setting in those states.

Abortion access had already been a problem in much of the country prior to 2021 because of burdensome and not medically necessary restrictions. Based on current political trends we are getting to a place where it is not hard to imagine that up to half of the states in this country will not allow their communities to access abortion care in the clinical setting at all in the very near future. This is not reproductive freedom, and I am outraged that people are being forced to travel hundreds of miles for their abortion care, forced to continue pregnancies that they don’t want, or forced to find other ways to obtain medication abortion pills.

While obtaining medication abortion pills online and managing the abortion process at home is safe and recognized as safe by the World Health Organization, no one should be forced to utilize a certain type of care based on their state of residence, in my opinion.

Providing evidence-based medicine to patients is ‘my duty’

Abortion care is health care and is primary care. One in four women will have an abortion by the age of 45, and we know that transgender, nonbinary, and gender-expansive people also have abortions. That means on any given day as family medicine physicians we are likely taking care of more than one person who has had an abortion, will have an abortion, and/or is considering an abortion. Therefore, all family medicine physicians need to be prepared to counsel patients about all of their pregnancy options, answer questions about pregnancy and abortion, and help people get the compassionate care that they deserve.

Our patients turn to us as trusted sources of information. When they reach out to us, I consider providing evidence-based medicine to patients – that includes factual information about abortion care if and when our patients need it – to be my duty as a family medicine physician.
 

Resources on abortion care for family medicine physicians

For family medicine physicians who did not have adequate exposure to abortion care during residency, there are many evidence-based resources to review in order to become more knowledgeable in abortion care.

In many areas of medicine, we have to continue to learn and seek out references, and abortion care is no different. One could argue that understanding abortion care and providing patients with factual information about their options and abortion care is even more important because of stigma surrounding abortion care and the rampant lies about abortion care that are easily accessible and that even other medical professionals and politicians spread. There are even fake clinics, often called “crisis pregnancy centers”, that intimidate, lie about abortion, and coerce patients to make decisions that are against their desires. Thus, being that trusted source of factual information about abortion care is even more important in the face of so many lies.

There are several organizations that are dedicated to education surrounding abortion care, in particular within the primary care setting. The Reproductive Health Access Project (RHAP), Reproductive Health Education in Family Medicine (RHEDI), and Training in Early Abortion for Comprehensive Healthcare (TEACH) all provide free resources on abortion care, how to incorporate abortion care into primary care, and how to teach medical students and residents about abortion care.

In addition, the National Network of Abortion Funds connects people to community-led organizations that provide assistance related to direct financial and logistical support for obtaining abortion care. I believe it is critical that we familiarize ourselves with our local abortion funds and share what we learn about these resources with our patients.

As abortion access continues to be further stripped away from many people that we take care of, I think standing up for what is right and what is our duty as physicians becomes more important. That duty is to provide our patients with evidence-based medicine and compassionate care so that our communities can obtain reproductive health outcomes and freedom that are best for their lives.
 

Dr. Lockley is a family physician currently living in Harlem, N.Y., and a member of the editorial advisory board of Family Practice News. She currently works for Public Health Solutions’ Sexual and Reproductive Health Centers in Brooklyn, providing primary care and reproductive health care services there, and as an abortion provider throughout the New York region. She completed both medical school and residency in Philadelphia and then did a fellowship in reproductive health care and advocacy through the Family Health Center of Harlem and the Reproductive Health Access Project. She can be reached at [email protected].