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Surgical de-escalation passes clinical test in low-risk cervical cancer
CHICAGO –
“Following adequate and rigorous preoperative assessment, and that’s key – very careful [patient selection] – simple hysterectomies can now be considered the new standard of care for patients with low-risk early-stage cervical cancer,” said Marie Plante, MD, during a presentation of the study at the annual meeting of the American Society of Clinical Oncology. A simple hysterectomy removes the uterus and cervix, while a radical hysterectomy also removes the parametrium and upper vagina.
Cervical cancer incidence has gone down over the past 2 decades as a result of improved screening, and patients tend to be lower in age and are more likely to have low-risk, early-stage disease, according to Dr. Plante. “Although radical surgery is highly effective for the treatment of low-risk disease, women are at risk of suffering survivorship issues related to long-term surgical side effects including compromised bladder, bowel, and sexual function,” said Dr. Plante, who is a professor of obstetrics and gynecology at Laval University and head of clinical research at l’Hôtel-Dieu de Québec, both in Quebec City.
Retrospective studies found that infiltration of the parametrium is quite rare in low-risk cases, “suggesting that less radical surgery may be a safe option associated with decreased morbidity – what we call surgical de-escalation,” said Dr. Plante.
To test that idea more rigorously, the researchers designed the SHAPE trial, which randomized 700 women to a simple hysterectomy or radical hysterectomy. Patients were carefully selected to be low risk, having squamous cell, adenocarcinoma, or adenosquamous carcinoma, stage IA2 or IB2 tumors, fewer than 10 mm of stromal invasion on loop electrosurgical excision procedure or cone biopsy, less than 50% stromal invasion seen in MRI, and a maximum tumor dimension of 20 mm or less. Tumors were grade I-III or not assessable.
Over a median follow-up of 4.5 years, pelvic recurrence was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group. The difference between the recurrence rate between the two groups was 0.35%, with an upper 95% confidence limit of 2.32%, below the threshold of 4% which had been predetermined as a benchmark for similar outcomes between the two groups. “Therefore, noninferiority of simple hysterectomy to radical hysterectomy could be concluded,” said Dr. Plante.
There were no statistically significant differences in intraoperative complications or mortality between the groups.
Surgery-related adverse events greater in radical hysterectomy group
There were some differences between the groups with respect to surgery-related adverse events. Within 4 weeks of surgery, there was a greater incidence of any adverse event in the radical hysterectomy group (50.6% vs. 42.6%; P = .04), as well as greater incidences of urinary incontinence (5.5% vs. 2.4%; P = .048) and urinary retention (11.0% vs. 0.6%; P < .0001). In the 4 weeks following surgery, there was a trend toward more surgery-related adverse events in the radical hysterectomy group (60.5% vs. 53.6%; P = .08) and higher incidences of urinary incontinence (11.0% vs. 4.7%; P = .003) and urinary retention (9.9% vs. 0.6%; P < .0001).
“Urinary incontinence and urinary retention are statistically worse in the radical hysterectomy group – both acutely, as well as [during] the following four weeks after surgery, suggesting that the problem persisted over time,” said Dr. Plante.
Dr. Plante also presented the study at a premeeting virtual press conference, during which Kathleen Moore, MD, provided comments on the study. She expressed enthusiasm about the results.
“Amongst those carefully selected tumors, radical hysterectomy can be converted to a simple hysterectomy, including minimally invasive. You still have to do nodes – that’s an important thing to remember – but you can do this without loss of oncologic control. And importantly, with reduction in surgical complications, postop morbidity, specifically neurologic morbidity. The moment this is presented [at the ASCO conference] this will be the new standard of care, and it represents a huge step forward in the care of women with early-stage cervical cancer,” said Dr. Moore, who is a professor of gynecologic oncology at the University of Oklahoma Health Sciences Center, Oklahoma City.
Also in the press conference, Dr. Plante emphasized the importance of a thorough understanding of the tumor, including size, imaging, and pathology. “The more conservative one wants to be, the more meticulous, the more careful one has to be to make sure that we’re truly dealing with low-risk patients.”
During the question-and-answer session following her presentation at the ASCO session, a moderator asked Dr. Plante if the presence of lymph vascular space invasion (LVSI) should prompt a radical hysterectomy.
Dr. Plante noted that about 13% of both radical and simple hysterectomy groups had LVSI present. “I think the key thing is careful selection, but I’m not sure that we should exclude LVSI [from consideration for simple hysterectomy] de facto,” she said.
Dr. Plante has consulted or advised Merck Serono and has received travel, accommodations, or other expenses from AstraZeneca. Dr. Moore has consulted, advised, and received research funding and travel expenses from numerous pharmaceutical companies.
CHICAGO –
“Following adequate and rigorous preoperative assessment, and that’s key – very careful [patient selection] – simple hysterectomies can now be considered the new standard of care for patients with low-risk early-stage cervical cancer,” said Marie Plante, MD, during a presentation of the study at the annual meeting of the American Society of Clinical Oncology. A simple hysterectomy removes the uterus and cervix, while a radical hysterectomy also removes the parametrium and upper vagina.
Cervical cancer incidence has gone down over the past 2 decades as a result of improved screening, and patients tend to be lower in age and are more likely to have low-risk, early-stage disease, according to Dr. Plante. “Although radical surgery is highly effective for the treatment of low-risk disease, women are at risk of suffering survivorship issues related to long-term surgical side effects including compromised bladder, bowel, and sexual function,” said Dr. Plante, who is a professor of obstetrics and gynecology at Laval University and head of clinical research at l’Hôtel-Dieu de Québec, both in Quebec City.
Retrospective studies found that infiltration of the parametrium is quite rare in low-risk cases, “suggesting that less radical surgery may be a safe option associated with decreased morbidity – what we call surgical de-escalation,” said Dr. Plante.
To test that idea more rigorously, the researchers designed the SHAPE trial, which randomized 700 women to a simple hysterectomy or radical hysterectomy. Patients were carefully selected to be low risk, having squamous cell, adenocarcinoma, or adenosquamous carcinoma, stage IA2 or IB2 tumors, fewer than 10 mm of stromal invasion on loop electrosurgical excision procedure or cone biopsy, less than 50% stromal invasion seen in MRI, and a maximum tumor dimension of 20 mm or less. Tumors were grade I-III or not assessable.
Over a median follow-up of 4.5 years, pelvic recurrence was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group. The difference between the recurrence rate between the two groups was 0.35%, with an upper 95% confidence limit of 2.32%, below the threshold of 4% which had been predetermined as a benchmark for similar outcomes between the two groups. “Therefore, noninferiority of simple hysterectomy to radical hysterectomy could be concluded,” said Dr. Plante.
There were no statistically significant differences in intraoperative complications or mortality between the groups.
Surgery-related adverse events greater in radical hysterectomy group
There were some differences between the groups with respect to surgery-related adverse events. Within 4 weeks of surgery, there was a greater incidence of any adverse event in the radical hysterectomy group (50.6% vs. 42.6%; P = .04), as well as greater incidences of urinary incontinence (5.5% vs. 2.4%; P = .048) and urinary retention (11.0% vs. 0.6%; P < .0001). In the 4 weeks following surgery, there was a trend toward more surgery-related adverse events in the radical hysterectomy group (60.5% vs. 53.6%; P = .08) and higher incidences of urinary incontinence (11.0% vs. 4.7%; P = .003) and urinary retention (9.9% vs. 0.6%; P < .0001).
“Urinary incontinence and urinary retention are statistically worse in the radical hysterectomy group – both acutely, as well as [during] the following four weeks after surgery, suggesting that the problem persisted over time,” said Dr. Plante.
Dr. Plante also presented the study at a premeeting virtual press conference, during which Kathleen Moore, MD, provided comments on the study. She expressed enthusiasm about the results.
“Amongst those carefully selected tumors, radical hysterectomy can be converted to a simple hysterectomy, including minimally invasive. You still have to do nodes – that’s an important thing to remember – but you can do this without loss of oncologic control. And importantly, with reduction in surgical complications, postop morbidity, specifically neurologic morbidity. The moment this is presented [at the ASCO conference] this will be the new standard of care, and it represents a huge step forward in the care of women with early-stage cervical cancer,” said Dr. Moore, who is a professor of gynecologic oncology at the University of Oklahoma Health Sciences Center, Oklahoma City.
Also in the press conference, Dr. Plante emphasized the importance of a thorough understanding of the tumor, including size, imaging, and pathology. “The more conservative one wants to be, the more meticulous, the more careful one has to be to make sure that we’re truly dealing with low-risk patients.”
During the question-and-answer session following her presentation at the ASCO session, a moderator asked Dr. Plante if the presence of lymph vascular space invasion (LVSI) should prompt a radical hysterectomy.
Dr. Plante noted that about 13% of both radical and simple hysterectomy groups had LVSI present. “I think the key thing is careful selection, but I’m not sure that we should exclude LVSI [from consideration for simple hysterectomy] de facto,” she said.
Dr. Plante has consulted or advised Merck Serono and has received travel, accommodations, or other expenses from AstraZeneca. Dr. Moore has consulted, advised, and received research funding and travel expenses from numerous pharmaceutical companies.
CHICAGO –
“Following adequate and rigorous preoperative assessment, and that’s key – very careful [patient selection] – simple hysterectomies can now be considered the new standard of care for patients with low-risk early-stage cervical cancer,” said Marie Plante, MD, during a presentation of the study at the annual meeting of the American Society of Clinical Oncology. A simple hysterectomy removes the uterus and cervix, while a radical hysterectomy also removes the parametrium and upper vagina.
Cervical cancer incidence has gone down over the past 2 decades as a result of improved screening, and patients tend to be lower in age and are more likely to have low-risk, early-stage disease, according to Dr. Plante. “Although radical surgery is highly effective for the treatment of low-risk disease, women are at risk of suffering survivorship issues related to long-term surgical side effects including compromised bladder, bowel, and sexual function,” said Dr. Plante, who is a professor of obstetrics and gynecology at Laval University and head of clinical research at l’Hôtel-Dieu de Québec, both in Quebec City.
Retrospective studies found that infiltration of the parametrium is quite rare in low-risk cases, “suggesting that less radical surgery may be a safe option associated with decreased morbidity – what we call surgical de-escalation,” said Dr. Plante.
To test that idea more rigorously, the researchers designed the SHAPE trial, which randomized 700 women to a simple hysterectomy or radical hysterectomy. Patients were carefully selected to be low risk, having squamous cell, adenocarcinoma, or adenosquamous carcinoma, stage IA2 or IB2 tumors, fewer than 10 mm of stromal invasion on loop electrosurgical excision procedure or cone biopsy, less than 50% stromal invasion seen in MRI, and a maximum tumor dimension of 20 mm or less. Tumors were grade I-III or not assessable.
Over a median follow-up of 4.5 years, pelvic recurrence was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group. The difference between the recurrence rate between the two groups was 0.35%, with an upper 95% confidence limit of 2.32%, below the threshold of 4% which had been predetermined as a benchmark for similar outcomes between the two groups. “Therefore, noninferiority of simple hysterectomy to radical hysterectomy could be concluded,” said Dr. Plante.
There were no statistically significant differences in intraoperative complications or mortality between the groups.
Surgery-related adverse events greater in radical hysterectomy group
There were some differences between the groups with respect to surgery-related adverse events. Within 4 weeks of surgery, there was a greater incidence of any adverse event in the radical hysterectomy group (50.6% vs. 42.6%; P = .04), as well as greater incidences of urinary incontinence (5.5% vs. 2.4%; P = .048) and urinary retention (11.0% vs. 0.6%; P < .0001). In the 4 weeks following surgery, there was a trend toward more surgery-related adverse events in the radical hysterectomy group (60.5% vs. 53.6%; P = .08) and higher incidences of urinary incontinence (11.0% vs. 4.7%; P = .003) and urinary retention (9.9% vs. 0.6%; P < .0001).
“Urinary incontinence and urinary retention are statistically worse in the radical hysterectomy group – both acutely, as well as [during] the following four weeks after surgery, suggesting that the problem persisted over time,” said Dr. Plante.
Dr. Plante also presented the study at a premeeting virtual press conference, during which Kathleen Moore, MD, provided comments on the study. She expressed enthusiasm about the results.
“Amongst those carefully selected tumors, radical hysterectomy can be converted to a simple hysterectomy, including minimally invasive. You still have to do nodes – that’s an important thing to remember – but you can do this without loss of oncologic control. And importantly, with reduction in surgical complications, postop morbidity, specifically neurologic morbidity. The moment this is presented [at the ASCO conference] this will be the new standard of care, and it represents a huge step forward in the care of women with early-stage cervical cancer,” said Dr. Moore, who is a professor of gynecologic oncology at the University of Oklahoma Health Sciences Center, Oklahoma City.
Also in the press conference, Dr. Plante emphasized the importance of a thorough understanding of the tumor, including size, imaging, and pathology. “The more conservative one wants to be, the more meticulous, the more careful one has to be to make sure that we’re truly dealing with low-risk patients.”
During the question-and-answer session following her presentation at the ASCO session, a moderator asked Dr. Plante if the presence of lymph vascular space invasion (LVSI) should prompt a radical hysterectomy.
Dr. Plante noted that about 13% of both radical and simple hysterectomy groups had LVSI present. “I think the key thing is careful selection, but I’m not sure that we should exclude LVSI [from consideration for simple hysterectomy] de facto,” she said.
Dr. Plante has consulted or advised Merck Serono and has received travel, accommodations, or other expenses from AstraZeneca. Dr. Moore has consulted, advised, and received research funding and travel expenses from numerous pharmaceutical companies.
AT ASCO 2023
Abortion restrictions linked to less evidence-based care for miscarriages
BALTIMORE – , according to a cross-sectional study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists and published in Obstetrics & Gynecology.
The results revealed that “abortion restrictions have far-reaching effects on early pregnancy loss care and on resident education,” the researchers concluded.
“Abortion restrictions don’t just affect people seeking abortions; they affect people also suffering from early pregnancy loss,” Aurora Phillips, MD, an ob.gyn. resident at Albany (N.Y.) Medical Center, said in an interview. “It’s harder to make that diagnosis and to be able to offer interventions, and these institutions that had restrictions also were less likely to have mifepristone or office based human aspiration, which are the most efficient and cost-effective interventions that we have.”
For example, less than half the programs surveyed offered mifepristone to help manage a miscarriage, “with availability varying inversely with abortion restrictions,” they found. After considering all characteristics of residency programs, “institutional abortion restrictions and bans were more important than state policies or religious affiliation in determining whether evidence-based early pregnancy loss treatments were available,” the researchers found, though their findings predated the Supreme Court’s Dobbs ruling that overturned Roe v. Wade. “Training institutions with a commitment to evidence-based family planning care and education are able to ensure access to the most evidence-based, cost-effective, and timely treatments for pregnancy loss even in the face of state abortion restrictions, thereby preserving patient safety, physician competency, and health care system sustainability,” they wrote.
Reduced access leads to higher risk interventions
An estimated 10%-20% of pregnancies result in early miscarriage, totaling more than one million cases in the U.S. each year. But since treatments for miscarriage often overlap with those for abortion, the researchers wondered whether differences existed in how providers managed miscarriages in states or institutions with strict abortion restrictions versus management in hospitals without restrictions.
They also looked at how closely the management strategies adhered to ACOG’s recommendations, which advise that providers consider both ultrasound imaging and other factors, including clinical reasoning and patient preferences, before diagnosing early pregnancy loss and considering possible interventions.
For imaging guidelines, ACOG endorses the criteria established for ultrasound diagnosis of first trimester pregnancy loss from the Society of Radiologists in 2012. But, the authors note, these guidelines are very conservative, exceeding previous measurements that had a 99%-100% predictive value for pregnancy loss, in the interest of “[prioritizing preservation of] fetal potential over facilitating expeditious care.” Hence the reason ACOG advises providers to include clinical judgment and patient preferences in their approach to care.
”In places where abortion is heavily regulated, clinicians managing miscarriages may cautiously rely on the strictest criteria to differentiate early pregnancy loss from potentially viable pregnancy and may not offer certain treatments commonly associated with abortion,” the authors noted. ACOG recommends surgical aspiration and medical treatment with both mifepristone and misoprostol as the safest and most effective options in managing miscarriages.
“Treating early pregnancy loss without the use of mifepristone is more likely to fail, is more likely to require an unscheduled procedure, and people who choose medication management for their miscarriages are usually trying to avoid a procedure, so that is the downside of not using mifepristone,” coauthor Rachel M. Flink-Bochacki, MD, an associate professor at Albany (N.Y.) Medical Center, said in an interview.
“Office-based uterine aspiration has the same safety profile as uterine aspiration in the operating room minus the risks of anesthesia and also helps patients get in faster because they don’t need to wait for OR time,” Dr. Flink-Bochacki explained. “So again, for a patient who wants an aspiration and does not want to pass the pregnancy at home, not having access to office-based aspiration could lead them to miscarry at home, which has higher risks and is not what they wanted.”
Reduced access to miscarriage care options in ‘hostile’ states
Among all 296 U.S. ob.gyn. residency programs that were contacted between November 2021 and January 2022, half (50.3%) responded to the researchers’ survey about their institutional practices around miscarriage, including location of diagnosis, use of ultrasound diagnostic guidelines, treatment options offered by their institution, and institutional restrictions on abortions based on indication.
The survey also collected characteristics of each program, including its state, setting, religious affiliation, and affiliation with the Ryan Training Program in Abortion and Family Planning. The responding sample had similar geographic distribution and state abortion policies as those who did not respond, but the responding programs were slightly more likely to be academic programs and to be affiliated with the Ryan program.
At the time of the study, prior to the Dobbs ruling, more than half the U.S. states had legislation restricting abortion care, and 57% of national teaching hospitals had internal restrictions that limited care based on gestational age and indication, particularly if the indication was elective, the authors reported. The researchers relied on designations from the Guttmacher Institute in December 2020 to categorize states as “hostile” to abortion (very hostile, hostile, and leans hostile) or non-hostile (neutral, leans supportive, supportive, and very supportive).
Most of the programs (80%) had no religious affiliation, but 11% had a Catholic affiliation and 5% had a different Christian affiliation. Institutional policies either had no restrictions on abortion care (38%), had restrictions (39%) based on certain maternal or fetal indications, or completely banned abortion services unless the mother’s life was threatened (23%). Among the Christian-affiliated programs, 60% had bans and 40% had restrictions.
Half (49.7%) of the responding programs relied rigidly on ultrasound criteria before offering any intervention for suspected early pregnancy loss, regardless of patient preferences. The other half (50.3%) incorporated ultrasound criteria and other factors, including clinical judgment and patient preferences, into a holistic determination of what options to present to the patient.
Before accounting for other factors, the researchers found that only a third (33%) of programs in states with severe abortion restrictions considered additional factors besides imaging when offering patients options for miscarriage management. In states without such abortion restrictions, 79% of programs considered both imaging and other factors (P < .001).
In states with “hostile abortion legislation,” only 32% of the programs used mifepristone for miscarriage management, compared with 75% of the programs in states without onerous abortion restrictions (P < .001). The results were similar for use of office-based suction aspiration: Just under half the programs (48%) in states with severe abortion restrictions included this technique as part of standard miscarriage management, compared with 68% of programs in states without such restrictions (P = .014).
Those findings match up with the experience of Cara Heuser, MD, a maternal-fetal medicine specialist from Salt Lake City, who was not involved in this study.
“We had a lot of restrictions even before Roe fell,” including heavy regulation of mifepristone, Dr. Heuser said in an interview. “In non-restricted states, it’s pretty easy to get, but even before Roe in our state, it was very, very difficult to get institutions and individual doctor’s offices to carry mifepristone to treat miscarriages. They were still treating miscarriages in a way that was known to be less effective.” Adding mifepristone to misoprostol reduces the risk of needing an evacuation surgery procedure, she explained, “so adding the mifepristone makes it safer.”
Institutional policies had the strongest impact
Before accounting for the state a hospital was in, 27% of institutions with restrictive abortion policies looked at more than imaging in determining how to proceed, compared with 88% of institutions without abortion restrictions that included clinical judgment and patient preferences in their management.
After controlling for state policies and affiliation with a family planning training program or a religious entity, the odds of an institution relying solely on imaging guidelines were over 12 times greater for institutions with abortion restrictions or bans (odds ratio, 12.3; 95% confidence interval, 3.2-47.9). Specifically, the odds were 9 times greater for institutions with restrictions and 27 times greater for institutions with bans.
Only 12% of the institutions without restrictions relied solely on ultrasound criteria, compared with 67% of the institutions with restrictions and 82% of the institutions that banned all abortions except to save the life of the pregnant individual (P < .001).
Only one in four (25%) of the programs with institutional abortion restrictions used mifepristone, compared with 86% of unrestricted programs (P < .001), and 40% of programs with institutional abortion restrictions used office-based aspiration, compared with 81% of unrestricted programs (P < .001).
Without access to all evidence-based treatments, doctors are often forced to choose expectant management for miscarriages. “So you’re kind of forced to have them to pass the pregnancy at home, which can be traumatic for patients” if that’s not what they wanted, Dr. Phillips said.
Dr. Flink-Bochacki further noted that this patient population is already particularly vulnerable.
“Especially for patients with early pregnancy loss, it’s such a feeling of powerlessness already, so the mental state that many of these patients are in is already quite fraught,” Dr. Flink-Bochacki said. “Then to not even have power to choose the interventions that you want or to be able to access interventions in a timely fashion because you’re being held to some arbitrary guideline further takes away the power and further exacerbates the trauma of the experience.”
The biggest factor likely driving the reduced access to those interventions is the fear that the care could be confused with providing an abortion instead of simply managing a miscarriage, Dr. Flink-Bochacki said. “I think that’s why a lot of these programs don’t have mifepristone and don’t offer outpatient uterine aspiration,” she said. “Because those are so widely used in abortion and the connotation is with abortion, they’re just kind of steering clear of it, but meanwhile, patients with pregnancy loss are suffering because they’re being unnecessarily restrictive.”
The research did not use any external funding, and the authors and Dr. Heuser had no disclosures.
BALTIMORE – , according to a cross-sectional study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists and published in Obstetrics & Gynecology.
The results revealed that “abortion restrictions have far-reaching effects on early pregnancy loss care and on resident education,” the researchers concluded.
“Abortion restrictions don’t just affect people seeking abortions; they affect people also suffering from early pregnancy loss,” Aurora Phillips, MD, an ob.gyn. resident at Albany (N.Y.) Medical Center, said in an interview. “It’s harder to make that diagnosis and to be able to offer interventions, and these institutions that had restrictions also were less likely to have mifepristone or office based human aspiration, which are the most efficient and cost-effective interventions that we have.”
For example, less than half the programs surveyed offered mifepristone to help manage a miscarriage, “with availability varying inversely with abortion restrictions,” they found. After considering all characteristics of residency programs, “institutional abortion restrictions and bans were more important than state policies or religious affiliation in determining whether evidence-based early pregnancy loss treatments were available,” the researchers found, though their findings predated the Supreme Court’s Dobbs ruling that overturned Roe v. Wade. “Training institutions with a commitment to evidence-based family planning care and education are able to ensure access to the most evidence-based, cost-effective, and timely treatments for pregnancy loss even in the face of state abortion restrictions, thereby preserving patient safety, physician competency, and health care system sustainability,” they wrote.
Reduced access leads to higher risk interventions
An estimated 10%-20% of pregnancies result in early miscarriage, totaling more than one million cases in the U.S. each year. But since treatments for miscarriage often overlap with those for abortion, the researchers wondered whether differences existed in how providers managed miscarriages in states or institutions with strict abortion restrictions versus management in hospitals without restrictions.
They also looked at how closely the management strategies adhered to ACOG’s recommendations, which advise that providers consider both ultrasound imaging and other factors, including clinical reasoning and patient preferences, before diagnosing early pregnancy loss and considering possible interventions.
For imaging guidelines, ACOG endorses the criteria established for ultrasound diagnosis of first trimester pregnancy loss from the Society of Radiologists in 2012. But, the authors note, these guidelines are very conservative, exceeding previous measurements that had a 99%-100% predictive value for pregnancy loss, in the interest of “[prioritizing preservation of] fetal potential over facilitating expeditious care.” Hence the reason ACOG advises providers to include clinical judgment and patient preferences in their approach to care.
”In places where abortion is heavily regulated, clinicians managing miscarriages may cautiously rely on the strictest criteria to differentiate early pregnancy loss from potentially viable pregnancy and may not offer certain treatments commonly associated with abortion,” the authors noted. ACOG recommends surgical aspiration and medical treatment with both mifepristone and misoprostol as the safest and most effective options in managing miscarriages.
“Treating early pregnancy loss without the use of mifepristone is more likely to fail, is more likely to require an unscheduled procedure, and people who choose medication management for their miscarriages are usually trying to avoid a procedure, so that is the downside of not using mifepristone,” coauthor Rachel M. Flink-Bochacki, MD, an associate professor at Albany (N.Y.) Medical Center, said in an interview.
“Office-based uterine aspiration has the same safety profile as uterine aspiration in the operating room minus the risks of anesthesia and also helps patients get in faster because they don’t need to wait for OR time,” Dr. Flink-Bochacki explained. “So again, for a patient who wants an aspiration and does not want to pass the pregnancy at home, not having access to office-based aspiration could lead them to miscarry at home, which has higher risks and is not what they wanted.”
Reduced access to miscarriage care options in ‘hostile’ states
Among all 296 U.S. ob.gyn. residency programs that were contacted between November 2021 and January 2022, half (50.3%) responded to the researchers’ survey about their institutional practices around miscarriage, including location of diagnosis, use of ultrasound diagnostic guidelines, treatment options offered by their institution, and institutional restrictions on abortions based on indication.
The survey also collected characteristics of each program, including its state, setting, religious affiliation, and affiliation with the Ryan Training Program in Abortion and Family Planning. The responding sample had similar geographic distribution and state abortion policies as those who did not respond, but the responding programs were slightly more likely to be academic programs and to be affiliated with the Ryan program.
At the time of the study, prior to the Dobbs ruling, more than half the U.S. states had legislation restricting abortion care, and 57% of national teaching hospitals had internal restrictions that limited care based on gestational age and indication, particularly if the indication was elective, the authors reported. The researchers relied on designations from the Guttmacher Institute in December 2020 to categorize states as “hostile” to abortion (very hostile, hostile, and leans hostile) or non-hostile (neutral, leans supportive, supportive, and very supportive).
Most of the programs (80%) had no religious affiliation, but 11% had a Catholic affiliation and 5% had a different Christian affiliation. Institutional policies either had no restrictions on abortion care (38%), had restrictions (39%) based on certain maternal or fetal indications, or completely banned abortion services unless the mother’s life was threatened (23%). Among the Christian-affiliated programs, 60% had bans and 40% had restrictions.
Half (49.7%) of the responding programs relied rigidly on ultrasound criteria before offering any intervention for suspected early pregnancy loss, regardless of patient preferences. The other half (50.3%) incorporated ultrasound criteria and other factors, including clinical judgment and patient preferences, into a holistic determination of what options to present to the patient.
Before accounting for other factors, the researchers found that only a third (33%) of programs in states with severe abortion restrictions considered additional factors besides imaging when offering patients options for miscarriage management. In states without such abortion restrictions, 79% of programs considered both imaging and other factors (P < .001).
In states with “hostile abortion legislation,” only 32% of the programs used mifepristone for miscarriage management, compared with 75% of the programs in states without onerous abortion restrictions (P < .001). The results were similar for use of office-based suction aspiration: Just under half the programs (48%) in states with severe abortion restrictions included this technique as part of standard miscarriage management, compared with 68% of programs in states without such restrictions (P = .014).
Those findings match up with the experience of Cara Heuser, MD, a maternal-fetal medicine specialist from Salt Lake City, who was not involved in this study.
“We had a lot of restrictions even before Roe fell,” including heavy regulation of mifepristone, Dr. Heuser said in an interview. “In non-restricted states, it’s pretty easy to get, but even before Roe in our state, it was very, very difficult to get institutions and individual doctor’s offices to carry mifepristone to treat miscarriages. They were still treating miscarriages in a way that was known to be less effective.” Adding mifepristone to misoprostol reduces the risk of needing an evacuation surgery procedure, she explained, “so adding the mifepristone makes it safer.”
Institutional policies had the strongest impact
Before accounting for the state a hospital was in, 27% of institutions with restrictive abortion policies looked at more than imaging in determining how to proceed, compared with 88% of institutions without abortion restrictions that included clinical judgment and patient preferences in their management.
After controlling for state policies and affiliation with a family planning training program or a religious entity, the odds of an institution relying solely on imaging guidelines were over 12 times greater for institutions with abortion restrictions or bans (odds ratio, 12.3; 95% confidence interval, 3.2-47.9). Specifically, the odds were 9 times greater for institutions with restrictions and 27 times greater for institutions with bans.
Only 12% of the institutions without restrictions relied solely on ultrasound criteria, compared with 67% of the institutions with restrictions and 82% of the institutions that banned all abortions except to save the life of the pregnant individual (P < .001).
Only one in four (25%) of the programs with institutional abortion restrictions used mifepristone, compared with 86% of unrestricted programs (P < .001), and 40% of programs with institutional abortion restrictions used office-based aspiration, compared with 81% of unrestricted programs (P < .001).
Without access to all evidence-based treatments, doctors are often forced to choose expectant management for miscarriages. “So you’re kind of forced to have them to pass the pregnancy at home, which can be traumatic for patients” if that’s not what they wanted, Dr. Phillips said.
Dr. Flink-Bochacki further noted that this patient population is already particularly vulnerable.
“Especially for patients with early pregnancy loss, it’s such a feeling of powerlessness already, so the mental state that many of these patients are in is already quite fraught,” Dr. Flink-Bochacki said. “Then to not even have power to choose the interventions that you want or to be able to access interventions in a timely fashion because you’re being held to some arbitrary guideline further takes away the power and further exacerbates the trauma of the experience.”
The biggest factor likely driving the reduced access to those interventions is the fear that the care could be confused with providing an abortion instead of simply managing a miscarriage, Dr. Flink-Bochacki said. “I think that’s why a lot of these programs don’t have mifepristone and don’t offer outpatient uterine aspiration,” she said. “Because those are so widely used in abortion and the connotation is with abortion, they’re just kind of steering clear of it, but meanwhile, patients with pregnancy loss are suffering because they’re being unnecessarily restrictive.”
The research did not use any external funding, and the authors and Dr. Heuser had no disclosures.
BALTIMORE – , according to a cross-sectional study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists and published in Obstetrics & Gynecology.
The results revealed that “abortion restrictions have far-reaching effects on early pregnancy loss care and on resident education,” the researchers concluded.
“Abortion restrictions don’t just affect people seeking abortions; they affect people also suffering from early pregnancy loss,” Aurora Phillips, MD, an ob.gyn. resident at Albany (N.Y.) Medical Center, said in an interview. “It’s harder to make that diagnosis and to be able to offer interventions, and these institutions that had restrictions also were less likely to have mifepristone or office based human aspiration, which are the most efficient and cost-effective interventions that we have.”
For example, less than half the programs surveyed offered mifepristone to help manage a miscarriage, “with availability varying inversely with abortion restrictions,” they found. After considering all characteristics of residency programs, “institutional abortion restrictions and bans were more important than state policies or religious affiliation in determining whether evidence-based early pregnancy loss treatments were available,” the researchers found, though their findings predated the Supreme Court’s Dobbs ruling that overturned Roe v. Wade. “Training institutions with a commitment to evidence-based family planning care and education are able to ensure access to the most evidence-based, cost-effective, and timely treatments for pregnancy loss even in the face of state abortion restrictions, thereby preserving patient safety, physician competency, and health care system sustainability,” they wrote.
Reduced access leads to higher risk interventions
An estimated 10%-20% of pregnancies result in early miscarriage, totaling more than one million cases in the U.S. each year. But since treatments for miscarriage often overlap with those for abortion, the researchers wondered whether differences existed in how providers managed miscarriages in states or institutions with strict abortion restrictions versus management in hospitals without restrictions.
They also looked at how closely the management strategies adhered to ACOG’s recommendations, which advise that providers consider both ultrasound imaging and other factors, including clinical reasoning and patient preferences, before diagnosing early pregnancy loss and considering possible interventions.
For imaging guidelines, ACOG endorses the criteria established for ultrasound diagnosis of first trimester pregnancy loss from the Society of Radiologists in 2012. But, the authors note, these guidelines are very conservative, exceeding previous measurements that had a 99%-100% predictive value for pregnancy loss, in the interest of “[prioritizing preservation of] fetal potential over facilitating expeditious care.” Hence the reason ACOG advises providers to include clinical judgment and patient preferences in their approach to care.
”In places where abortion is heavily regulated, clinicians managing miscarriages may cautiously rely on the strictest criteria to differentiate early pregnancy loss from potentially viable pregnancy and may not offer certain treatments commonly associated with abortion,” the authors noted. ACOG recommends surgical aspiration and medical treatment with both mifepristone and misoprostol as the safest and most effective options in managing miscarriages.
“Treating early pregnancy loss without the use of mifepristone is more likely to fail, is more likely to require an unscheduled procedure, and people who choose medication management for their miscarriages are usually trying to avoid a procedure, so that is the downside of not using mifepristone,” coauthor Rachel M. Flink-Bochacki, MD, an associate professor at Albany (N.Y.) Medical Center, said in an interview.
“Office-based uterine aspiration has the same safety profile as uterine aspiration in the operating room minus the risks of anesthesia and also helps patients get in faster because they don’t need to wait for OR time,” Dr. Flink-Bochacki explained. “So again, for a patient who wants an aspiration and does not want to pass the pregnancy at home, not having access to office-based aspiration could lead them to miscarry at home, which has higher risks and is not what they wanted.”
Reduced access to miscarriage care options in ‘hostile’ states
Among all 296 U.S. ob.gyn. residency programs that were contacted between November 2021 and January 2022, half (50.3%) responded to the researchers’ survey about their institutional practices around miscarriage, including location of diagnosis, use of ultrasound diagnostic guidelines, treatment options offered by their institution, and institutional restrictions on abortions based on indication.
The survey also collected characteristics of each program, including its state, setting, religious affiliation, and affiliation with the Ryan Training Program in Abortion and Family Planning. The responding sample had similar geographic distribution and state abortion policies as those who did not respond, but the responding programs were slightly more likely to be academic programs and to be affiliated with the Ryan program.
At the time of the study, prior to the Dobbs ruling, more than half the U.S. states had legislation restricting abortion care, and 57% of national teaching hospitals had internal restrictions that limited care based on gestational age and indication, particularly if the indication was elective, the authors reported. The researchers relied on designations from the Guttmacher Institute in December 2020 to categorize states as “hostile” to abortion (very hostile, hostile, and leans hostile) or non-hostile (neutral, leans supportive, supportive, and very supportive).
Most of the programs (80%) had no religious affiliation, but 11% had a Catholic affiliation and 5% had a different Christian affiliation. Institutional policies either had no restrictions on abortion care (38%), had restrictions (39%) based on certain maternal or fetal indications, or completely banned abortion services unless the mother’s life was threatened (23%). Among the Christian-affiliated programs, 60% had bans and 40% had restrictions.
Half (49.7%) of the responding programs relied rigidly on ultrasound criteria before offering any intervention for suspected early pregnancy loss, regardless of patient preferences. The other half (50.3%) incorporated ultrasound criteria and other factors, including clinical judgment and patient preferences, into a holistic determination of what options to present to the patient.
Before accounting for other factors, the researchers found that only a third (33%) of programs in states with severe abortion restrictions considered additional factors besides imaging when offering patients options for miscarriage management. In states without such abortion restrictions, 79% of programs considered both imaging and other factors (P < .001).
In states with “hostile abortion legislation,” only 32% of the programs used mifepristone for miscarriage management, compared with 75% of the programs in states without onerous abortion restrictions (P < .001). The results were similar for use of office-based suction aspiration: Just under half the programs (48%) in states with severe abortion restrictions included this technique as part of standard miscarriage management, compared with 68% of programs in states without such restrictions (P = .014).
Those findings match up with the experience of Cara Heuser, MD, a maternal-fetal medicine specialist from Salt Lake City, who was not involved in this study.
“We had a lot of restrictions even before Roe fell,” including heavy regulation of mifepristone, Dr. Heuser said in an interview. “In non-restricted states, it’s pretty easy to get, but even before Roe in our state, it was very, very difficult to get institutions and individual doctor’s offices to carry mifepristone to treat miscarriages. They were still treating miscarriages in a way that was known to be less effective.” Adding mifepristone to misoprostol reduces the risk of needing an evacuation surgery procedure, she explained, “so adding the mifepristone makes it safer.”
Institutional policies had the strongest impact
Before accounting for the state a hospital was in, 27% of institutions with restrictive abortion policies looked at more than imaging in determining how to proceed, compared with 88% of institutions without abortion restrictions that included clinical judgment and patient preferences in their management.
After controlling for state policies and affiliation with a family planning training program or a religious entity, the odds of an institution relying solely on imaging guidelines were over 12 times greater for institutions with abortion restrictions or bans (odds ratio, 12.3; 95% confidence interval, 3.2-47.9). Specifically, the odds were 9 times greater for institutions with restrictions and 27 times greater for institutions with bans.
Only 12% of the institutions without restrictions relied solely on ultrasound criteria, compared with 67% of the institutions with restrictions and 82% of the institutions that banned all abortions except to save the life of the pregnant individual (P < .001).
Only one in four (25%) of the programs with institutional abortion restrictions used mifepristone, compared with 86% of unrestricted programs (P < .001), and 40% of programs with institutional abortion restrictions used office-based aspiration, compared with 81% of unrestricted programs (P < .001).
Without access to all evidence-based treatments, doctors are often forced to choose expectant management for miscarriages. “So you’re kind of forced to have them to pass the pregnancy at home, which can be traumatic for patients” if that’s not what they wanted, Dr. Phillips said.
Dr. Flink-Bochacki further noted that this patient population is already particularly vulnerable.
“Especially for patients with early pregnancy loss, it’s such a feeling of powerlessness already, so the mental state that many of these patients are in is already quite fraught,” Dr. Flink-Bochacki said. “Then to not even have power to choose the interventions that you want or to be able to access interventions in a timely fashion because you’re being held to some arbitrary guideline further takes away the power and further exacerbates the trauma of the experience.”
The biggest factor likely driving the reduced access to those interventions is the fear that the care could be confused with providing an abortion instead of simply managing a miscarriage, Dr. Flink-Bochacki said. “I think that’s why a lot of these programs don’t have mifepristone and don’t offer outpatient uterine aspiration,” she said. “Because those are so widely used in abortion and the connotation is with abortion, they’re just kind of steering clear of it, but meanwhile, patients with pregnancy loss are suffering because they’re being unnecessarily restrictive.”
The research did not use any external funding, and the authors and Dr. Heuser had no disclosures.
AT ACOG 2023
First prospective study finds pregnancies with Sjögren’s to be largely safe
Women with Sjögren’s syndrome have pregnancy outcomes similar to those of the general population, according to the first study to prospectively track pregnancy outcomes among people with the autoimmune condition.
“Most early studies of pregnancy in rheumatic disease patients were retrospective and included only small numbers, making it difficult to know how generalizable the reported results were,” said Lisa Sammaritano, MD, a rheumatologist at Hospital for Special Surgery in New York, in an email interview with this news organization. She was not involved with the research.
Most of these previous studies suggested an increased risk of adverse outcomes, such as miscarriages, preterm deliveries, and small-for-gestational-age birth weight. But in addition to small patient numbers, retrospective studies “are subject to greater reporting bias, which may predispose patients with negative outcomes being more likely to be included because they were followed more closely,” Dr. Sammaritano said.
“This prospective study has several advantages over the earlier retrospective reports: The same data were collected in the same way for all the patients, the patients were recruited at similar time points, and – due to the multicenter nature of the cohort – numbers are larger than in prior studies. All these factors make the results stronger and more generalizable to the Sjögren’s patients we see in our practices,” she added.
In the study, published May 8 in The Lancet Rheumatology, first author Grégoire Martin de Frémont, MD, of the rheumatology service at Bicêtre Hospital, Paris-Saclay University and colleagues used the GR2 registry, an observational database of pregnancies of women with systemic autoimmune diseases managed at 76 participating centers in France, to identify pregnant women with primary Sjögren’s syndrome. To avoid bias, only women who entered the database before 18 weeks’ gestation were included. The final cohort included 106 pregnancies in 96 women with primary Sjögren’s syndrome and 420 control pregnancies that were matched from the general population.
Adverse pregnancy outcomes, including preterm delivery (< 37 weeks of gestation), intrauterine growth retardation, and low birth weight occurred in nine pregnancies (9%) in the Sjögren’s syndrome group and in 28 pregnancies in the control group (7%). Adverse pregnancy outcomes were not significantly associated with Sjögren’s syndrome (P = .52). Researchers found that there were more adverse pregnancy outcomes among women with Sjögren’s syndrome with antiphospholipid (aPL) antibodies. Negative outcomes also increased among those with anti-RNP antibodies, but this association was not statistically significant.
“The main message – based on strong data from a well-designed study – is that patients with Sjögren’s overall do as well as the general population in terms of standard adverse pregnancy outcomes. The rate of flare of Sjögren’s disease was relatively low during the second and third trimesters, also reassuring,” Dr. Sammaritano said. She noted that the association between adverse pregnancy outcomes and aPL antibodies was not unexpected, given that they are a known risk factor.
The study authors recommend that patients with Sjögren’s syndrome be screened for aPL and anti-RNP antibodies prior to conception because of the potential increased risk for complications and that patients with positive screens be closely monitored during their pregnancy.
Dr. Sammaritano noted that there are other health problems to keep in mind. “It is important to remember that Sjögren’s patients – more than any other rheumatic disease patients – have the additional risk for neonatal lupus and complete heart block in their infant, since about two-thirds of Sjögren’s patients are positive for anti-Ro/SSA antibody,” she said. “This is a distinct issue related to the presence of this antibody alone and not specifically related to the underlying diagnosis. In clinical practice, positive anti-Ro/SSA antibody is often the main reason for counseling, monitoring, and even recommending therapy (hydroxychloroquine) in these patients.”
The study received funding from Lupus France, the France Association of Scleroderma, and the Association Gougerot Sjögren, among others. Dr. Sammaritano reports no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Women with Sjögren’s syndrome have pregnancy outcomes similar to those of the general population, according to the first study to prospectively track pregnancy outcomes among people with the autoimmune condition.
“Most early studies of pregnancy in rheumatic disease patients were retrospective and included only small numbers, making it difficult to know how generalizable the reported results were,” said Lisa Sammaritano, MD, a rheumatologist at Hospital for Special Surgery in New York, in an email interview with this news organization. She was not involved with the research.
Most of these previous studies suggested an increased risk of adverse outcomes, such as miscarriages, preterm deliveries, and small-for-gestational-age birth weight. But in addition to small patient numbers, retrospective studies “are subject to greater reporting bias, which may predispose patients with negative outcomes being more likely to be included because they were followed more closely,” Dr. Sammaritano said.
“This prospective study has several advantages over the earlier retrospective reports: The same data were collected in the same way for all the patients, the patients were recruited at similar time points, and – due to the multicenter nature of the cohort – numbers are larger than in prior studies. All these factors make the results stronger and more generalizable to the Sjögren’s patients we see in our practices,” she added.
In the study, published May 8 in The Lancet Rheumatology, first author Grégoire Martin de Frémont, MD, of the rheumatology service at Bicêtre Hospital, Paris-Saclay University and colleagues used the GR2 registry, an observational database of pregnancies of women with systemic autoimmune diseases managed at 76 participating centers in France, to identify pregnant women with primary Sjögren’s syndrome. To avoid bias, only women who entered the database before 18 weeks’ gestation were included. The final cohort included 106 pregnancies in 96 women with primary Sjögren’s syndrome and 420 control pregnancies that were matched from the general population.
Adverse pregnancy outcomes, including preterm delivery (< 37 weeks of gestation), intrauterine growth retardation, and low birth weight occurred in nine pregnancies (9%) in the Sjögren’s syndrome group and in 28 pregnancies in the control group (7%). Adverse pregnancy outcomes were not significantly associated with Sjögren’s syndrome (P = .52). Researchers found that there were more adverse pregnancy outcomes among women with Sjögren’s syndrome with antiphospholipid (aPL) antibodies. Negative outcomes also increased among those with anti-RNP antibodies, but this association was not statistically significant.
“The main message – based on strong data from a well-designed study – is that patients with Sjögren’s overall do as well as the general population in terms of standard adverse pregnancy outcomes. The rate of flare of Sjögren’s disease was relatively low during the second and third trimesters, also reassuring,” Dr. Sammaritano said. She noted that the association between adverse pregnancy outcomes and aPL antibodies was not unexpected, given that they are a known risk factor.
The study authors recommend that patients with Sjögren’s syndrome be screened for aPL and anti-RNP antibodies prior to conception because of the potential increased risk for complications and that patients with positive screens be closely monitored during their pregnancy.
Dr. Sammaritano noted that there are other health problems to keep in mind. “It is important to remember that Sjögren’s patients – more than any other rheumatic disease patients – have the additional risk for neonatal lupus and complete heart block in their infant, since about two-thirds of Sjögren’s patients are positive for anti-Ro/SSA antibody,” she said. “This is a distinct issue related to the presence of this antibody alone and not specifically related to the underlying diagnosis. In clinical practice, positive anti-Ro/SSA antibody is often the main reason for counseling, monitoring, and even recommending therapy (hydroxychloroquine) in these patients.”
The study received funding from Lupus France, the France Association of Scleroderma, and the Association Gougerot Sjögren, among others. Dr. Sammaritano reports no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Women with Sjögren’s syndrome have pregnancy outcomes similar to those of the general population, according to the first study to prospectively track pregnancy outcomes among people with the autoimmune condition.
“Most early studies of pregnancy in rheumatic disease patients were retrospective and included only small numbers, making it difficult to know how generalizable the reported results were,” said Lisa Sammaritano, MD, a rheumatologist at Hospital for Special Surgery in New York, in an email interview with this news organization. She was not involved with the research.
Most of these previous studies suggested an increased risk of adverse outcomes, such as miscarriages, preterm deliveries, and small-for-gestational-age birth weight. But in addition to small patient numbers, retrospective studies “are subject to greater reporting bias, which may predispose patients with negative outcomes being more likely to be included because they were followed more closely,” Dr. Sammaritano said.
“This prospective study has several advantages over the earlier retrospective reports: The same data were collected in the same way for all the patients, the patients were recruited at similar time points, and – due to the multicenter nature of the cohort – numbers are larger than in prior studies. All these factors make the results stronger and more generalizable to the Sjögren’s patients we see in our practices,” she added.
In the study, published May 8 in The Lancet Rheumatology, first author Grégoire Martin de Frémont, MD, of the rheumatology service at Bicêtre Hospital, Paris-Saclay University and colleagues used the GR2 registry, an observational database of pregnancies of women with systemic autoimmune diseases managed at 76 participating centers in France, to identify pregnant women with primary Sjögren’s syndrome. To avoid bias, only women who entered the database before 18 weeks’ gestation were included. The final cohort included 106 pregnancies in 96 women with primary Sjögren’s syndrome and 420 control pregnancies that were matched from the general population.
Adverse pregnancy outcomes, including preterm delivery (< 37 weeks of gestation), intrauterine growth retardation, and low birth weight occurred in nine pregnancies (9%) in the Sjögren’s syndrome group and in 28 pregnancies in the control group (7%). Adverse pregnancy outcomes were not significantly associated with Sjögren’s syndrome (P = .52). Researchers found that there were more adverse pregnancy outcomes among women with Sjögren’s syndrome with antiphospholipid (aPL) antibodies. Negative outcomes also increased among those with anti-RNP antibodies, but this association was not statistically significant.
“The main message – based on strong data from a well-designed study – is that patients with Sjögren’s overall do as well as the general population in terms of standard adverse pregnancy outcomes. The rate of flare of Sjögren’s disease was relatively low during the second and third trimesters, also reassuring,” Dr. Sammaritano said. She noted that the association between adverse pregnancy outcomes and aPL antibodies was not unexpected, given that they are a known risk factor.
The study authors recommend that patients with Sjögren’s syndrome be screened for aPL and anti-RNP antibodies prior to conception because of the potential increased risk for complications and that patients with positive screens be closely monitored during their pregnancy.
Dr. Sammaritano noted that there are other health problems to keep in mind. “It is important to remember that Sjögren’s patients – more than any other rheumatic disease patients – have the additional risk for neonatal lupus and complete heart block in their infant, since about two-thirds of Sjögren’s patients are positive for anti-Ro/SSA antibody,” she said. “This is a distinct issue related to the presence of this antibody alone and not specifically related to the underlying diagnosis. In clinical practice, positive anti-Ro/SSA antibody is often the main reason for counseling, monitoring, and even recommending therapy (hydroxychloroquine) in these patients.”
The study received funding from Lupus France, the France Association of Scleroderma, and the Association Gougerot Sjögren, among others. Dr. Sammaritano reports no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM THE LANCET RHEUMATOLOGY
Common fracture risk predictors often fail for women of any race
according to a study published in JAMA Internal Medicine.
One of the screenings, the U.S. Fracture Risk Assessment Tool (FRAX), proved relatively ineffective at identifying women who developed osteoporosis. The other screening, the Osteoporosis Self-Assessment Tool (OST), excelled at identifying osteoporosis for women in every racial and ethnic group, but also failed at identifying who was most likely to experience a fracture. Osteoporosis experts say that primary care physicians should test for the condition in anyone with any risk factor for it, even if a screening tool suggests doing so is unnecessary.
The United States Preventive Services Task Force (USPSTF) recommends routine testing of bone mineral density in women age 65 years and older to detect risk of developing osteoporosis, which in turn leads to an increased risk for fractures of the hip, spine, shoulder, or forearm. For women aged 50-64, whether bone mineral density accurately reflects who will develop osteoporosis is less clear. In this age range, the USPSTF recommends using either FRAX or OST rather than routine bone mineral density tests.
“I have the utmost respect for the United States Preventive Services Task Force, which lists both of these as valid screening tools for younger postmenopausal women. What I hope this study does is to inform the next iteration of the screening guidelines,” by maintaining the recommendation to use the OST while not keeping FRAX, said Carolyn J. Crandall, MD, MS, an internal medicine physician and health services researcher at University of California, Los Angeles, who helped conduct the research.
The U.S. version of FRAX requires identifying someone’s race, height, and weight, then answering whether they have different risk factors for a fracture such as a previous fracture, rheumatoid arthritis, or smoking. The result was thought to indicate a cumulative risk for major fracture over the next 10 years. Patients at significant risk should then undergo a bone density test.
The tool can also incorporate information about bone mineral density, if available, but the FRAX analyses in Dr. Crandall’s study did not include those data because the study aimed to test the measure’s predictive ability in the absence of a bone scan.
The OST includes only two variables – weight and age – to calculate risk for osteoporosis, and generally takes seconds to complete. It does not include race. As with FRAX, anyone deemed at significant risk for developing osteoporosis should undergo a bone density test.
“OST is really simple; that makes it very appealing,” Dr. Crandall said. “OST could probably be automatically calculated in the electronic medical record.”
Using data from the Women’s Health Initiative, Dr. Crandall and colleagues tracked more than 67,000 women aged 50-64 years for 10 years following enrollment in the study to see who experienced a fracture or developed osteoporosis over that decade. The investigators found that neither FRAX nor OST was particularly good at predicting who went on to experience a fracture.
The accuracy of FRAX at fracture prediction peaked at 65% for Asian women (area under the receiver operating curve, 0.65; 95% confidence interval, 0.58-0.71), and was lowest for Black women (AUC 0.55; 95% CI, 0.52-0.59). OST also was most accurate for Asian women, but only up to 62% (AUC 0.62; 95% CI, 0.56-0.69), and was again lowest for Black women (AUC 0.53; 95% CI, 0.50 - 0.57)
“It is just very hard to predict fractures in this age group,” Dr. Crandall said, noting that more evidence exists about risk for fracture in people older than 65.
The story diverges with predicting risk of osteoporosis in the neck. The OST did this roughly 80% of the time, for all racial groups. That figure proved better than FRAX, without including race.
Treatment gap
“This evidence supports using OST instead of FRAX” for selecting younger postmenopausal women who should undergo a bone mineral density exam, said E. Michael Lewiecki, MD, director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque.
Dr. Lewiecki, who was not involved in the new study, noted that the U.S. version of FRAX specifies race because of some clinical evidence that different races have different rates of fracture. But he and Dr. Crandall said the validity of race-based algorithms to guide clinical care is a controversial and evolving topic in medicine. Dr. Lewiecki said the Canadian version of FRAX, which is similarly applied to a diverse population as in the United States, omits race and works as well as the U.S. version. Future iterations of the instrument in the United States may not include race, Dr. Lewiecki said.
“The study is perfectly valid as far as it goes. But the big gorilla in the room is that most patients who need a bone density test are not getting it,” Dr. Lewiecki added. Sometimes a patient might break a bone in their wrist, for example, and tell their primary care provider that anyone would have broken that bone because the fall was so hard. Even if that’s true, Dr. Lewiecki said, any woman older than 45 who has broken a bone should undergo a bone density test to determine if they have osteoporosis, even if it seems like there are other possible reasons for why the break occurred.
“Most of the clinical practice guidelines that are used by physicians recommend getting a bone density test in postmenopausal women under the age of 65 who have a risk factor for fracture,” Dr. Lewiecki said, with a primary risk factor being a prior fracture. Dr. Lewiecki said he would rather that anyone who could benefit from a bone density test receive it, rather than someone foregoing a scan based on a screening tool that may be flawed.
“Most patients – men and women – who have osteoporosis are currently not being identified. Even when they are being identified, they are commonly not being treated. And when they are started on treatment, many patients discontinue treatment before they’ve taken it long enough to benefit,” Dr. Lewiecki said.
Dr. Crandall and Dr. Lewiecki report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a study published in JAMA Internal Medicine.
One of the screenings, the U.S. Fracture Risk Assessment Tool (FRAX), proved relatively ineffective at identifying women who developed osteoporosis. The other screening, the Osteoporosis Self-Assessment Tool (OST), excelled at identifying osteoporosis for women in every racial and ethnic group, but also failed at identifying who was most likely to experience a fracture. Osteoporosis experts say that primary care physicians should test for the condition in anyone with any risk factor for it, even if a screening tool suggests doing so is unnecessary.
The United States Preventive Services Task Force (USPSTF) recommends routine testing of bone mineral density in women age 65 years and older to detect risk of developing osteoporosis, which in turn leads to an increased risk for fractures of the hip, spine, shoulder, or forearm. For women aged 50-64, whether bone mineral density accurately reflects who will develop osteoporosis is less clear. In this age range, the USPSTF recommends using either FRAX or OST rather than routine bone mineral density tests.
“I have the utmost respect for the United States Preventive Services Task Force, which lists both of these as valid screening tools for younger postmenopausal women. What I hope this study does is to inform the next iteration of the screening guidelines,” by maintaining the recommendation to use the OST while not keeping FRAX, said Carolyn J. Crandall, MD, MS, an internal medicine physician and health services researcher at University of California, Los Angeles, who helped conduct the research.
The U.S. version of FRAX requires identifying someone’s race, height, and weight, then answering whether they have different risk factors for a fracture such as a previous fracture, rheumatoid arthritis, or smoking. The result was thought to indicate a cumulative risk for major fracture over the next 10 years. Patients at significant risk should then undergo a bone density test.
The tool can also incorporate information about bone mineral density, if available, but the FRAX analyses in Dr. Crandall’s study did not include those data because the study aimed to test the measure’s predictive ability in the absence of a bone scan.
The OST includes only two variables – weight and age – to calculate risk for osteoporosis, and generally takes seconds to complete. It does not include race. As with FRAX, anyone deemed at significant risk for developing osteoporosis should undergo a bone density test.
“OST is really simple; that makes it very appealing,” Dr. Crandall said. “OST could probably be automatically calculated in the electronic medical record.”
Using data from the Women’s Health Initiative, Dr. Crandall and colleagues tracked more than 67,000 women aged 50-64 years for 10 years following enrollment in the study to see who experienced a fracture or developed osteoporosis over that decade. The investigators found that neither FRAX nor OST was particularly good at predicting who went on to experience a fracture.
The accuracy of FRAX at fracture prediction peaked at 65% for Asian women (area under the receiver operating curve, 0.65; 95% confidence interval, 0.58-0.71), and was lowest for Black women (AUC 0.55; 95% CI, 0.52-0.59). OST also was most accurate for Asian women, but only up to 62% (AUC 0.62; 95% CI, 0.56-0.69), and was again lowest for Black women (AUC 0.53; 95% CI, 0.50 - 0.57)
“It is just very hard to predict fractures in this age group,” Dr. Crandall said, noting that more evidence exists about risk for fracture in people older than 65.
The story diverges with predicting risk of osteoporosis in the neck. The OST did this roughly 80% of the time, for all racial groups. That figure proved better than FRAX, without including race.
Treatment gap
“This evidence supports using OST instead of FRAX” for selecting younger postmenopausal women who should undergo a bone mineral density exam, said E. Michael Lewiecki, MD, director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque.
Dr. Lewiecki, who was not involved in the new study, noted that the U.S. version of FRAX specifies race because of some clinical evidence that different races have different rates of fracture. But he and Dr. Crandall said the validity of race-based algorithms to guide clinical care is a controversial and evolving topic in medicine. Dr. Lewiecki said the Canadian version of FRAX, which is similarly applied to a diverse population as in the United States, omits race and works as well as the U.S. version. Future iterations of the instrument in the United States may not include race, Dr. Lewiecki said.
“The study is perfectly valid as far as it goes. But the big gorilla in the room is that most patients who need a bone density test are not getting it,” Dr. Lewiecki added. Sometimes a patient might break a bone in their wrist, for example, and tell their primary care provider that anyone would have broken that bone because the fall was so hard. Even if that’s true, Dr. Lewiecki said, any woman older than 45 who has broken a bone should undergo a bone density test to determine if they have osteoporosis, even if it seems like there are other possible reasons for why the break occurred.
“Most of the clinical practice guidelines that are used by physicians recommend getting a bone density test in postmenopausal women under the age of 65 who have a risk factor for fracture,” Dr. Lewiecki said, with a primary risk factor being a prior fracture. Dr. Lewiecki said he would rather that anyone who could benefit from a bone density test receive it, rather than someone foregoing a scan based on a screening tool that may be flawed.
“Most patients – men and women – who have osteoporosis are currently not being identified. Even when they are being identified, they are commonly not being treated. And when they are started on treatment, many patients discontinue treatment before they’ve taken it long enough to benefit,” Dr. Lewiecki said.
Dr. Crandall and Dr. Lewiecki report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a study published in JAMA Internal Medicine.
One of the screenings, the U.S. Fracture Risk Assessment Tool (FRAX), proved relatively ineffective at identifying women who developed osteoporosis. The other screening, the Osteoporosis Self-Assessment Tool (OST), excelled at identifying osteoporosis for women in every racial and ethnic group, but also failed at identifying who was most likely to experience a fracture. Osteoporosis experts say that primary care physicians should test for the condition in anyone with any risk factor for it, even if a screening tool suggests doing so is unnecessary.
The United States Preventive Services Task Force (USPSTF) recommends routine testing of bone mineral density in women age 65 years and older to detect risk of developing osteoporosis, which in turn leads to an increased risk for fractures of the hip, spine, shoulder, or forearm. For women aged 50-64, whether bone mineral density accurately reflects who will develop osteoporosis is less clear. In this age range, the USPSTF recommends using either FRAX or OST rather than routine bone mineral density tests.
“I have the utmost respect for the United States Preventive Services Task Force, which lists both of these as valid screening tools for younger postmenopausal women. What I hope this study does is to inform the next iteration of the screening guidelines,” by maintaining the recommendation to use the OST while not keeping FRAX, said Carolyn J. Crandall, MD, MS, an internal medicine physician and health services researcher at University of California, Los Angeles, who helped conduct the research.
The U.S. version of FRAX requires identifying someone’s race, height, and weight, then answering whether they have different risk factors for a fracture such as a previous fracture, rheumatoid arthritis, or smoking. The result was thought to indicate a cumulative risk for major fracture over the next 10 years. Patients at significant risk should then undergo a bone density test.
The tool can also incorporate information about bone mineral density, if available, but the FRAX analyses in Dr. Crandall’s study did not include those data because the study aimed to test the measure’s predictive ability in the absence of a bone scan.
The OST includes only two variables – weight and age – to calculate risk for osteoporosis, and generally takes seconds to complete. It does not include race. As with FRAX, anyone deemed at significant risk for developing osteoporosis should undergo a bone density test.
“OST is really simple; that makes it very appealing,” Dr. Crandall said. “OST could probably be automatically calculated in the electronic medical record.”
Using data from the Women’s Health Initiative, Dr. Crandall and colleagues tracked more than 67,000 women aged 50-64 years for 10 years following enrollment in the study to see who experienced a fracture or developed osteoporosis over that decade. The investigators found that neither FRAX nor OST was particularly good at predicting who went on to experience a fracture.
The accuracy of FRAX at fracture prediction peaked at 65% for Asian women (area under the receiver operating curve, 0.65; 95% confidence interval, 0.58-0.71), and was lowest for Black women (AUC 0.55; 95% CI, 0.52-0.59). OST also was most accurate for Asian women, but only up to 62% (AUC 0.62; 95% CI, 0.56-0.69), and was again lowest for Black women (AUC 0.53; 95% CI, 0.50 - 0.57)
“It is just very hard to predict fractures in this age group,” Dr. Crandall said, noting that more evidence exists about risk for fracture in people older than 65.
The story diverges with predicting risk of osteoporosis in the neck. The OST did this roughly 80% of the time, for all racial groups. That figure proved better than FRAX, without including race.
Treatment gap
“This evidence supports using OST instead of FRAX” for selecting younger postmenopausal women who should undergo a bone mineral density exam, said E. Michael Lewiecki, MD, director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque.
Dr. Lewiecki, who was not involved in the new study, noted that the U.S. version of FRAX specifies race because of some clinical evidence that different races have different rates of fracture. But he and Dr. Crandall said the validity of race-based algorithms to guide clinical care is a controversial and evolving topic in medicine. Dr. Lewiecki said the Canadian version of FRAX, which is similarly applied to a diverse population as in the United States, omits race and works as well as the U.S. version. Future iterations of the instrument in the United States may not include race, Dr. Lewiecki said.
“The study is perfectly valid as far as it goes. But the big gorilla in the room is that most patients who need a bone density test are not getting it,” Dr. Lewiecki added. Sometimes a patient might break a bone in their wrist, for example, and tell their primary care provider that anyone would have broken that bone because the fall was so hard. Even if that’s true, Dr. Lewiecki said, any woman older than 45 who has broken a bone should undergo a bone density test to determine if they have osteoporosis, even if it seems like there are other possible reasons for why the break occurred.
“Most of the clinical practice guidelines that are used by physicians recommend getting a bone density test in postmenopausal women under the age of 65 who have a risk factor for fracture,” Dr. Lewiecki said, with a primary risk factor being a prior fracture. Dr. Lewiecki said he would rather that anyone who could benefit from a bone density test receive it, rather than someone foregoing a scan based on a screening tool that may be flawed.
“Most patients – men and women – who have osteoporosis are currently not being identified. Even when they are being identified, they are commonly not being treated. And when they are started on treatment, many patients discontinue treatment before they’ve taken it long enough to benefit,” Dr. Lewiecki said.
Dr. Crandall and Dr. Lewiecki report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE
Youth-led sexual health program improves teen knowledge, autonomy
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
While the small pilot study focused primarily on assessing feasibility and effectiveness, the results suggest potential for scaling the program up to reach a larger audience and assessing the knowledge disseminated from direct youth participants.
“The good thing about this subject is that not a lot of it has to be context-specific,” Saumya Sao, a clinical researcher in gynecology and obstetrics at the Johns Hopkins University, Baltimore, and the study’s lead author, said in an interview. “A lot of it is just baseline information that everybody needs and doesn’t get.”
Jaime Friedman, MD, a pediatrician and director of marketing at Children’s Primary Care Medical Group in San Diego, was not involved in the study but was impressed with the program’s objectives and results so far.
“While education is massively important, teens don’t always want to hear it from their parents or other adults,” Dr. Friedman said in an interview. “Learning from their peers is one way to overcome this hurdle.”
Given the high rate of sexually transmitted infections and unintended pregnancies in youth, paired with low sexual and reproductive health literacy in this population, the researchers sought to learn whether a program focused on peer-to-peer health education on these topics was feasible. The goal was to increase youth sexual and reproductive health knowledge, self-efficacy, and autonomy using a youth-led intervention.
The researchers hosted nine monthly, interactive, youth-led sessions that lasted 2 hours over Zoom or in person. Incorporated into the meetings were principles from Youth Participatory Action Research (YPAR) and Positive Youth Development (PYD).
The major topics included the following: Use of social media, values and goal-setting, anatomy and menstrual health, risk factors of sexual activities , STI and HIV prevention, contraceptive methods, healthy relationships and consent, practice responding to unhealthy behavior, gender and sexuality, and social media and body image.
The 24 participants were provided with transportation to the study site at the researchers’ institution and received financial compensation for their participation. They were an average 15.8 years old, lived in the greater Baltimore area, and mostly self-identified as female. Eight percent identified as non-binary and half (50%) identified as LGBTQIA+. Just over half the participants (52%) were Black/African American, 28% were Asian/Asian American, 12% were White, and 8% were Hispanic. The participants attended an average 88% of the sessions throughout the full intervention.
For each of the nine sessions, more than 50% of participants reported that they “learned a lot,” and only one participant reported for one session (session 5) that they “didn’t learn” anything. The researchers assessed participants’ knowledge, self-efficacy, and sense of autonomy at baseline and after completion of the intervention. Significant improvements occurred across all areas.
The average score improved by 31% in sexual and reproductive health knowledge (P < .001), 33% in sexual and reproductive health services awareness (P = .002), 46% in advocacy and empowerment (P < .001), 16% in general perceived efficacy (P = .002), and 22% personal sexuality empowerment (P = .006).
Ms. Sao said she was very pleased to see that the improvements were significant in every domain they measured, which she attributed largely to the incorporation of YPAR and PYD into the program.
“We approached it using these two frameworks that really do focus on involving youth in the teaching themselves, so I think that’s what increased their general perceived efficacy and advocacy empowerment without us necessarily having to emphasize, ‘You are advocates,’” Ms. Sao said. “Those frameworks ask the youth for their opinions and then give the youth an opportunity in every single session to be teachers themselves, and I think that lends itself well to all of the domains.”
Ms. Sao was also pleasantly surprised at the high level of retention across the 9 months.
“Every single session was slotted for 2 hours, but they would want to stay for 3 hours. Eventually, we actually started meeting with them twice a month, just adding an extra session,” she said. “As they gained confidence, they were so excited to be peer educators and realized, ‘I can really do this. I can teach my peers. We’re not getting this from anywhere else.’ ”
Ms. Sao and another study author, Maclaine Barré-Quick, an undergraduate research assistant at Johns Hopkins University, said the participants quickly discovered how easy it was to have a non-stigmatizing conversation about many of the topics once a subject was brought up.
“They’re actively looking for that opportunity,” Ms. Barré-Quick said in an interview.
Dr. Friedman agreed that this type of program provides what many adolescents need in a way that they may welcome more than through other methods.
“Adolescents’ bodies are approaching adulthood and function like adults, but their brains are still developing. They don’t have the worldly experience and education of adults, but they think they know everything,” Dr. Friedman said. “They are a population known for their high risk behavior due to their natural impulsivity. This can be a scary combination, especially when it comes to sexual health.”
But if teens don’t want to hear some of the information they need from adults, they may be more open to hearing it from other teens, Dr. Friedman said.
“Using an evidence-based approach ensures the desired outcome of healthier habits, decreased STIs and decreased teen pregnancy,” Dr. Friedman said. “It also adds weight to the argument against abstinence-only education. Teens deserve accurate and evidence-based education about their own bodies.”
Ms. Sao said the next steps will be exploring ways to scale the program up, such as putting the curriculum resources into a bundle available to other educators. They’re also looking at ways to put it into an online platform that’s self-paced, though that requires solving the challenge of having synchronous meetings for youth-led discussion.
“There are certain kinks that we have to work out because there were some activities where I think the students really benefited from having those open discussions with each other, so [we need to determine] how to replicate that in an online format,” Ms. Sao said.
Dr. Friedman agreed that scalability appears to be the biggest challenge, along with funding programs. But if those obstacles can be overcome, such programs would complement and expand on the education she does currently with families.
“I don’t have time for a full sex ed course at each visit,” Dr. Friedman said. “I would like to be able to direct them to a program that I know works and would be easy for them to complete. Even better, this would be an amazing program to ‘sell’ to practices interested in hosting these sessions themselves.”
Ms. Sao said they also hope to assess the impact of the intervention on the participants’ peers to see how well the knowledge and self-efficacy spread through the youths’ teaching.
No external funding was noted. One author reported research support from Hologic and Merck. Dr. Friedman had no disclosures.
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
While the small pilot study focused primarily on assessing feasibility and effectiveness, the results suggest potential for scaling the program up to reach a larger audience and assessing the knowledge disseminated from direct youth participants.
“The good thing about this subject is that not a lot of it has to be context-specific,” Saumya Sao, a clinical researcher in gynecology and obstetrics at the Johns Hopkins University, Baltimore, and the study’s lead author, said in an interview. “A lot of it is just baseline information that everybody needs and doesn’t get.”
Jaime Friedman, MD, a pediatrician and director of marketing at Children’s Primary Care Medical Group in San Diego, was not involved in the study but was impressed with the program’s objectives and results so far.
“While education is massively important, teens don’t always want to hear it from their parents or other adults,” Dr. Friedman said in an interview. “Learning from their peers is one way to overcome this hurdle.”
Given the high rate of sexually transmitted infections and unintended pregnancies in youth, paired with low sexual and reproductive health literacy in this population, the researchers sought to learn whether a program focused on peer-to-peer health education on these topics was feasible. The goal was to increase youth sexual and reproductive health knowledge, self-efficacy, and autonomy using a youth-led intervention.
The researchers hosted nine monthly, interactive, youth-led sessions that lasted 2 hours over Zoom or in person. Incorporated into the meetings were principles from Youth Participatory Action Research (YPAR) and Positive Youth Development (PYD).
The major topics included the following: Use of social media, values and goal-setting, anatomy and menstrual health, risk factors of sexual activities , STI and HIV prevention, contraceptive methods, healthy relationships and consent, practice responding to unhealthy behavior, gender and sexuality, and social media and body image.
The 24 participants were provided with transportation to the study site at the researchers’ institution and received financial compensation for their participation. They were an average 15.8 years old, lived in the greater Baltimore area, and mostly self-identified as female. Eight percent identified as non-binary and half (50%) identified as LGBTQIA+. Just over half the participants (52%) were Black/African American, 28% were Asian/Asian American, 12% were White, and 8% were Hispanic. The participants attended an average 88% of the sessions throughout the full intervention.
For each of the nine sessions, more than 50% of participants reported that they “learned a lot,” and only one participant reported for one session (session 5) that they “didn’t learn” anything. The researchers assessed participants’ knowledge, self-efficacy, and sense of autonomy at baseline and after completion of the intervention. Significant improvements occurred across all areas.
The average score improved by 31% in sexual and reproductive health knowledge (P < .001), 33% in sexual and reproductive health services awareness (P = .002), 46% in advocacy and empowerment (P < .001), 16% in general perceived efficacy (P = .002), and 22% personal sexuality empowerment (P = .006).
Ms. Sao said she was very pleased to see that the improvements were significant in every domain they measured, which she attributed largely to the incorporation of YPAR and PYD into the program.
“We approached it using these two frameworks that really do focus on involving youth in the teaching themselves, so I think that’s what increased their general perceived efficacy and advocacy empowerment without us necessarily having to emphasize, ‘You are advocates,’” Ms. Sao said. “Those frameworks ask the youth for their opinions and then give the youth an opportunity in every single session to be teachers themselves, and I think that lends itself well to all of the domains.”
Ms. Sao was also pleasantly surprised at the high level of retention across the 9 months.
“Every single session was slotted for 2 hours, but they would want to stay for 3 hours. Eventually, we actually started meeting with them twice a month, just adding an extra session,” she said. “As they gained confidence, they were so excited to be peer educators and realized, ‘I can really do this. I can teach my peers. We’re not getting this from anywhere else.’ ”
Ms. Sao and another study author, Maclaine Barré-Quick, an undergraduate research assistant at Johns Hopkins University, said the participants quickly discovered how easy it was to have a non-stigmatizing conversation about many of the topics once a subject was brought up.
“They’re actively looking for that opportunity,” Ms. Barré-Quick said in an interview.
Dr. Friedman agreed that this type of program provides what many adolescents need in a way that they may welcome more than through other methods.
“Adolescents’ bodies are approaching adulthood and function like adults, but their brains are still developing. They don’t have the worldly experience and education of adults, but they think they know everything,” Dr. Friedman said. “They are a population known for their high risk behavior due to their natural impulsivity. This can be a scary combination, especially when it comes to sexual health.”
But if teens don’t want to hear some of the information they need from adults, they may be more open to hearing it from other teens, Dr. Friedman said.
“Using an evidence-based approach ensures the desired outcome of healthier habits, decreased STIs and decreased teen pregnancy,” Dr. Friedman said. “It also adds weight to the argument against abstinence-only education. Teens deserve accurate and evidence-based education about their own bodies.”
Ms. Sao said the next steps will be exploring ways to scale the program up, such as putting the curriculum resources into a bundle available to other educators. They’re also looking at ways to put it into an online platform that’s self-paced, though that requires solving the challenge of having synchronous meetings for youth-led discussion.
“There are certain kinks that we have to work out because there were some activities where I think the students really benefited from having those open discussions with each other, so [we need to determine] how to replicate that in an online format,” Ms. Sao said.
Dr. Friedman agreed that scalability appears to be the biggest challenge, along with funding programs. But if those obstacles can be overcome, such programs would complement and expand on the education she does currently with families.
“I don’t have time for a full sex ed course at each visit,” Dr. Friedman said. “I would like to be able to direct them to a program that I know works and would be easy for them to complete. Even better, this would be an amazing program to ‘sell’ to practices interested in hosting these sessions themselves.”
Ms. Sao said they also hope to assess the impact of the intervention on the participants’ peers to see how well the knowledge and self-efficacy spread through the youths’ teaching.
No external funding was noted. One author reported research support from Hologic and Merck. Dr. Friedman had no disclosures.
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
While the small pilot study focused primarily on assessing feasibility and effectiveness, the results suggest potential for scaling the program up to reach a larger audience and assessing the knowledge disseminated from direct youth participants.
“The good thing about this subject is that not a lot of it has to be context-specific,” Saumya Sao, a clinical researcher in gynecology and obstetrics at the Johns Hopkins University, Baltimore, and the study’s lead author, said in an interview. “A lot of it is just baseline information that everybody needs and doesn’t get.”
Jaime Friedman, MD, a pediatrician and director of marketing at Children’s Primary Care Medical Group in San Diego, was not involved in the study but was impressed with the program’s objectives and results so far.
“While education is massively important, teens don’t always want to hear it from their parents or other adults,” Dr. Friedman said in an interview. “Learning from their peers is one way to overcome this hurdle.”
Given the high rate of sexually transmitted infections and unintended pregnancies in youth, paired with low sexual and reproductive health literacy in this population, the researchers sought to learn whether a program focused on peer-to-peer health education on these topics was feasible. The goal was to increase youth sexual and reproductive health knowledge, self-efficacy, and autonomy using a youth-led intervention.
The researchers hosted nine monthly, interactive, youth-led sessions that lasted 2 hours over Zoom or in person. Incorporated into the meetings were principles from Youth Participatory Action Research (YPAR) and Positive Youth Development (PYD).
The major topics included the following: Use of social media, values and goal-setting, anatomy and menstrual health, risk factors of sexual activities , STI and HIV prevention, contraceptive methods, healthy relationships and consent, practice responding to unhealthy behavior, gender and sexuality, and social media and body image.
The 24 participants were provided with transportation to the study site at the researchers’ institution and received financial compensation for their participation. They were an average 15.8 years old, lived in the greater Baltimore area, and mostly self-identified as female. Eight percent identified as non-binary and half (50%) identified as LGBTQIA+. Just over half the participants (52%) were Black/African American, 28% were Asian/Asian American, 12% were White, and 8% were Hispanic. The participants attended an average 88% of the sessions throughout the full intervention.
For each of the nine sessions, more than 50% of participants reported that they “learned a lot,” and only one participant reported for one session (session 5) that they “didn’t learn” anything. The researchers assessed participants’ knowledge, self-efficacy, and sense of autonomy at baseline and after completion of the intervention. Significant improvements occurred across all areas.
The average score improved by 31% in sexual and reproductive health knowledge (P < .001), 33% in sexual and reproductive health services awareness (P = .002), 46% in advocacy and empowerment (P < .001), 16% in general perceived efficacy (P = .002), and 22% personal sexuality empowerment (P = .006).
Ms. Sao said she was very pleased to see that the improvements were significant in every domain they measured, which she attributed largely to the incorporation of YPAR and PYD into the program.
“We approached it using these two frameworks that really do focus on involving youth in the teaching themselves, so I think that’s what increased their general perceived efficacy and advocacy empowerment without us necessarily having to emphasize, ‘You are advocates,’” Ms. Sao said. “Those frameworks ask the youth for their opinions and then give the youth an opportunity in every single session to be teachers themselves, and I think that lends itself well to all of the domains.”
Ms. Sao was also pleasantly surprised at the high level of retention across the 9 months.
“Every single session was slotted for 2 hours, but they would want to stay for 3 hours. Eventually, we actually started meeting with them twice a month, just adding an extra session,” she said. “As they gained confidence, they were so excited to be peer educators and realized, ‘I can really do this. I can teach my peers. We’re not getting this from anywhere else.’ ”
Ms. Sao and another study author, Maclaine Barré-Quick, an undergraduate research assistant at Johns Hopkins University, said the participants quickly discovered how easy it was to have a non-stigmatizing conversation about many of the topics once a subject was brought up.
“They’re actively looking for that opportunity,” Ms. Barré-Quick said in an interview.
Dr. Friedman agreed that this type of program provides what many adolescents need in a way that they may welcome more than through other methods.
“Adolescents’ bodies are approaching adulthood and function like adults, but their brains are still developing. They don’t have the worldly experience and education of adults, but they think they know everything,” Dr. Friedman said. “They are a population known for their high risk behavior due to their natural impulsivity. This can be a scary combination, especially when it comes to sexual health.”
But if teens don’t want to hear some of the information they need from adults, they may be more open to hearing it from other teens, Dr. Friedman said.
“Using an evidence-based approach ensures the desired outcome of healthier habits, decreased STIs and decreased teen pregnancy,” Dr. Friedman said. “It also adds weight to the argument against abstinence-only education. Teens deserve accurate and evidence-based education about their own bodies.”
Ms. Sao said the next steps will be exploring ways to scale the program up, such as putting the curriculum resources into a bundle available to other educators. They’re also looking at ways to put it into an online platform that’s self-paced, though that requires solving the challenge of having synchronous meetings for youth-led discussion.
“There are certain kinks that we have to work out because there were some activities where I think the students really benefited from having those open discussions with each other, so [we need to determine] how to replicate that in an online format,” Ms. Sao said.
Dr. Friedman agreed that scalability appears to be the biggest challenge, along with funding programs. But if those obstacles can be overcome, such programs would complement and expand on the education she does currently with families.
“I don’t have time for a full sex ed course at each visit,” Dr. Friedman said. “I would like to be able to direct them to a program that I know works and would be easy for them to complete. Even better, this would be an amazing program to ‘sell’ to practices interested in hosting these sessions themselves.”
Ms. Sao said they also hope to assess the impact of the intervention on the participants’ peers to see how well the knowledge and self-efficacy spread through the youths’ teaching.
No external funding was noted. One author reported research support from Hologic and Merck. Dr. Friedman had no disclosures.
AT ACOG 2023
Female sexual pleasure: Is it in the water?
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. In a secondary analysis also presented at the meeting, the lubricants were found not to alter the vaginal microbiome.
Using these types of lubricants during vaginal intercourse at least once a week over a 4-week period resulted in a statistically significant increase of over four points in the 36-point Female Sexual Function Index (FSFI), a self-reported measure of sexual functioning, for participants, said Michael Krychman, MD, executive director of the Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, the senior author of the study. Statistically significant improvements also were observed in individual areas such as sexual desire and arousal, orgasm, and satisfaction. Results of the study have been published in the Journal of Sexual Medicine.
In the open-label, five-arm, parallel study conducted in Germany, 174 women aged 18-65 years were randomly assigned to use one of five lubricants from three popular brands. After a 4-week run-in period with no use of lubricants, participants were shown how to apply the products and instructed to use the substances during vaginal intercourse at least once a week over a 4-week period.
Participants reported experiencing mild to moderate vaginal dryness and dyspareunia during vaginal intercourse within the previous 3 months.
Statistically significant improvements were seen across all six individual domain scores of the FSFI (desire, arousal, lubrication, orgasm, satisfaction, and pain reduction) from baseline to week 4 with all five lubricants (P < .0001 for lubrication and pain reduction; P < .05 for desire, arousal, orgasm, and satisfaction), according to the researchers.
After 4 weeks, a clinically meaningful improvement in the total FSFI score was observed for four lubricants among premenopausal women and for all lubricants among postmenopausal women. The percentage of participants with sexual function as defined as a score of at least 26.55 on the FSFI was significantly greater after treatment (76.9%) than before treatment (20.8%; P < .0001).
“You would assume if you’re using lubricant it would improve the dryness, but what was very exciting for us is that it improved desire, it improved orgasm, it improved arousal,” Dr. Krychman said in an interview. Like concentric overlapping circles of female sexual function, he said, “if you improve one aspect, you improve the other.”
Nearly 80 nonserious adverse effects occurred in 43 participants, five of which were thought to be possibly attributed to the products, such as vulvovaginal burning, itching, or discomfort. In questionnaires, most women agreed that using the lubricants made sex more enjoyable and provided an overall pleasant experience.
One limitation of the study is that because most participants were Caucasian, the results may not be generalizable to all populations, according to the researchers. Further research is required to fully determine safety and efficacy in patients of all races and ethnicities, they reported, especially given that vaginal dryness has been reported more frequently in non-White ethnic groups.
In a companion presentation, Dr. Krychman discussed another aspect of the study looking at the lubricants’ effects on the vaginal microbiome. Repeated application of the products did not significantly alter the vaginal microbiome for up to 4 weeks, and vaginal pH slightly increased in all treatment groups shortly after use but was restored in most cases after a day.
Water-based lubricants are recommended by the WHO for use with condoms because they do not erode latex, said Karen Adams, MD, professor emeritus of obstetrics and gynecology and founding director of the Menopause and Sexual Medicine Program at Oregon Health & Science University, Portland. Guidelines from the group recommend lubricants should have an osmolality that is as close to normal vaginal secretions as possible to decrease the likelihood of irritation or other side effects, she said. Some available lubricants have four to six times that osmolality, which potentially could dehydrate cells, achieving the opposite of the desired effect.
“The reason this is important is they’re trying to develop lubricants that are more ‘vaginal friendly’ and more in line with the WHO guidelines,” said Dr. Adams, who is joining Stanford (Calif.) University in July to create and lead a new program in menopause and healthy aging. “They came up with four formulas consistent with WHO guidelines to see if these new ones worked at least as well [as commercially available products with higher osmolality], and it turns out they did,” she said. “They worked just fine.”
The study was funded by Reckitt Healthcare. Dr. Krychman is a paid medical consultant for the company. Dr. Adams disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. In a secondary analysis also presented at the meeting, the lubricants were found not to alter the vaginal microbiome.
Using these types of lubricants during vaginal intercourse at least once a week over a 4-week period resulted in a statistically significant increase of over four points in the 36-point Female Sexual Function Index (FSFI), a self-reported measure of sexual functioning, for participants, said Michael Krychman, MD, executive director of the Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, the senior author of the study. Statistically significant improvements also were observed in individual areas such as sexual desire and arousal, orgasm, and satisfaction. Results of the study have been published in the Journal of Sexual Medicine.
In the open-label, five-arm, parallel study conducted in Germany, 174 women aged 18-65 years were randomly assigned to use one of five lubricants from three popular brands. After a 4-week run-in period with no use of lubricants, participants were shown how to apply the products and instructed to use the substances during vaginal intercourse at least once a week over a 4-week period.
Participants reported experiencing mild to moderate vaginal dryness and dyspareunia during vaginal intercourse within the previous 3 months.
Statistically significant improvements were seen across all six individual domain scores of the FSFI (desire, arousal, lubrication, orgasm, satisfaction, and pain reduction) from baseline to week 4 with all five lubricants (P < .0001 for lubrication and pain reduction; P < .05 for desire, arousal, orgasm, and satisfaction), according to the researchers.
After 4 weeks, a clinically meaningful improvement in the total FSFI score was observed for four lubricants among premenopausal women and for all lubricants among postmenopausal women. The percentage of participants with sexual function as defined as a score of at least 26.55 on the FSFI was significantly greater after treatment (76.9%) than before treatment (20.8%; P < .0001).
“You would assume if you’re using lubricant it would improve the dryness, but what was very exciting for us is that it improved desire, it improved orgasm, it improved arousal,” Dr. Krychman said in an interview. Like concentric overlapping circles of female sexual function, he said, “if you improve one aspect, you improve the other.”
Nearly 80 nonserious adverse effects occurred in 43 participants, five of which were thought to be possibly attributed to the products, such as vulvovaginal burning, itching, or discomfort. In questionnaires, most women agreed that using the lubricants made sex more enjoyable and provided an overall pleasant experience.
One limitation of the study is that because most participants were Caucasian, the results may not be generalizable to all populations, according to the researchers. Further research is required to fully determine safety and efficacy in patients of all races and ethnicities, they reported, especially given that vaginal dryness has been reported more frequently in non-White ethnic groups.
In a companion presentation, Dr. Krychman discussed another aspect of the study looking at the lubricants’ effects on the vaginal microbiome. Repeated application of the products did not significantly alter the vaginal microbiome for up to 4 weeks, and vaginal pH slightly increased in all treatment groups shortly after use but was restored in most cases after a day.
Water-based lubricants are recommended by the WHO for use with condoms because they do not erode latex, said Karen Adams, MD, professor emeritus of obstetrics and gynecology and founding director of the Menopause and Sexual Medicine Program at Oregon Health & Science University, Portland. Guidelines from the group recommend lubricants should have an osmolality that is as close to normal vaginal secretions as possible to decrease the likelihood of irritation or other side effects, she said. Some available lubricants have four to six times that osmolality, which potentially could dehydrate cells, achieving the opposite of the desired effect.
“The reason this is important is they’re trying to develop lubricants that are more ‘vaginal friendly’ and more in line with the WHO guidelines,” said Dr. Adams, who is joining Stanford (Calif.) University in July to create and lead a new program in menopause and healthy aging. “They came up with four formulas consistent with WHO guidelines to see if these new ones worked at least as well [as commercially available products with higher osmolality], and it turns out they did,” she said. “They worked just fine.”
The study was funded by Reckitt Healthcare. Dr. Krychman is a paid medical consultant for the company. Dr. Adams disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. In a secondary analysis also presented at the meeting, the lubricants were found not to alter the vaginal microbiome.
Using these types of lubricants during vaginal intercourse at least once a week over a 4-week period resulted in a statistically significant increase of over four points in the 36-point Female Sexual Function Index (FSFI), a self-reported measure of sexual functioning, for participants, said Michael Krychman, MD, executive director of the Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, the senior author of the study. Statistically significant improvements also were observed in individual areas such as sexual desire and arousal, orgasm, and satisfaction. Results of the study have been published in the Journal of Sexual Medicine.
In the open-label, five-arm, parallel study conducted in Germany, 174 women aged 18-65 years were randomly assigned to use one of five lubricants from three popular brands. After a 4-week run-in period with no use of lubricants, participants were shown how to apply the products and instructed to use the substances during vaginal intercourse at least once a week over a 4-week period.
Participants reported experiencing mild to moderate vaginal dryness and dyspareunia during vaginal intercourse within the previous 3 months.
Statistically significant improvements were seen across all six individual domain scores of the FSFI (desire, arousal, lubrication, orgasm, satisfaction, and pain reduction) from baseline to week 4 with all five lubricants (P < .0001 for lubrication and pain reduction; P < .05 for desire, arousal, orgasm, and satisfaction), according to the researchers.
After 4 weeks, a clinically meaningful improvement in the total FSFI score was observed for four lubricants among premenopausal women and for all lubricants among postmenopausal women. The percentage of participants with sexual function as defined as a score of at least 26.55 on the FSFI was significantly greater after treatment (76.9%) than before treatment (20.8%; P < .0001).
“You would assume if you’re using lubricant it would improve the dryness, but what was very exciting for us is that it improved desire, it improved orgasm, it improved arousal,” Dr. Krychman said in an interview. Like concentric overlapping circles of female sexual function, he said, “if you improve one aspect, you improve the other.”
Nearly 80 nonserious adverse effects occurred in 43 participants, five of which were thought to be possibly attributed to the products, such as vulvovaginal burning, itching, or discomfort. In questionnaires, most women agreed that using the lubricants made sex more enjoyable and provided an overall pleasant experience.
One limitation of the study is that because most participants were Caucasian, the results may not be generalizable to all populations, according to the researchers. Further research is required to fully determine safety and efficacy in patients of all races and ethnicities, they reported, especially given that vaginal dryness has been reported more frequently in non-White ethnic groups.
In a companion presentation, Dr. Krychman discussed another aspect of the study looking at the lubricants’ effects on the vaginal microbiome. Repeated application of the products did not significantly alter the vaginal microbiome for up to 4 weeks, and vaginal pH slightly increased in all treatment groups shortly after use but was restored in most cases after a day.
Water-based lubricants are recommended by the WHO for use with condoms because they do not erode latex, said Karen Adams, MD, professor emeritus of obstetrics and gynecology and founding director of the Menopause and Sexual Medicine Program at Oregon Health & Science University, Portland. Guidelines from the group recommend lubricants should have an osmolality that is as close to normal vaginal secretions as possible to decrease the likelihood of irritation or other side effects, she said. Some available lubricants have four to six times that osmolality, which potentially could dehydrate cells, achieving the opposite of the desired effect.
“The reason this is important is they’re trying to develop lubricants that are more ‘vaginal friendly’ and more in line with the WHO guidelines,” said Dr. Adams, who is joining Stanford (Calif.) University in July to create and lead a new program in menopause and healthy aging. “They came up with four formulas consistent with WHO guidelines to see if these new ones worked at least as well [as commercially available products with higher osmolality], and it turns out they did,” she said. “They worked just fine.”
The study was funded by Reckitt Healthcare. Dr. Krychman is a paid medical consultant for the company. Dr. Adams disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT ACOG 2023
Maternal health clinic teams with legal services to aid patients
BALTIMORE – A novel partnership between a legal services program and a maternal health clinic is helping pregnant patients with issues such as housing or employment discrimination.
The Perinatal Legal Assistance and Well-being (P-LAW) program at Georgetown University, Washington, launched 2 years ago as a collaboration between GU’s Health Justice Alliance clinic and the Women’s and Infants Services division of nearby MedStar Washington Hospital Center, integrating attorneys into the health care team to offer no-cost legal aid for its diverse, urban population during the perinatal period. Since then, the effort has assisted more than 120 women.
“Our goal was to see how integrating a lawyer can help address some of those issues that, unfortunately, providers are not able to assist with because they go beyond the hospital or clinic walls,” said Roxana Richardson, JD, the project director and managing attorney for P-LAW, during a poster presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Our initial findings showed that there are issues that patients were facing that needed an intervention from an attorney. We trained the providers and social workers to identify these issues so that we could intervene.”
Improving health by tackling legal barriers
, Ms. Richardson said.
The program is one of few medical-legal partnerships specifically focused on the perinatal population. P-LAW is one component of a larger initiative at MedStar Health called DC Safe Babies Safe Moms. The initiative includes integrated mental health programming, treatment of health conditions that complicate pregnancy, assessments of social determinants of health, expanded support for lactation and nutrition, access to home visiting referrals, and extended postpartum follow-up. The work is supported through the A. James & Alice B. Clark Foundation.
Patients are evaluated for health-harming legal needs as part of a comprehensive social and behavioral health screening at their initial prenatal visit, 28-week appointment, and postpartum visit. Those who screen positive are contacted by a referral specialist on the health care team who confirms the patient has an active legal need and would like to be connected to the P-LAW team. The team then reaches out to conduct a legal intake and determine the appropriate course of action.
From March 2021 through February of this year, Ms. Richardson and others with the program have provided legal representation to 123 patients on 186 legal issues in areas such as public benefits, employment, and housing and family concerns. Services range from advising patients on steps they can take on their own (like reporting a housing condition issue to the Department of Buildings), to sending letters on patients’ behalf, to appearing in court. Most patients served were in their second and third trimesters of pregnancy. The majority were Black or African American, aged 20-34 years, and had incomes below 100% of the federal poverty level.
The most common legal issues were in the areas of public benefits (SNAP/food stamps, cash assistance), employment (parental leave, discrimination), housing (conditions, eviction), and family law (child support, domestic violence). Among the 186 issues, work has been completed on 106 concerns and 33 still have a case open; for 47, the client withdrew or ceased contact, Ms. Richardson reported.
Most times when obstetricians hear concerns like these, they wonder what to do, said Tamika Auguste, MD, chair of obstetrics and gynecology at MedStar Health. Having the P-LAW program as a resource is a huge help, she said. If patients express concerns, or if obstetricians uncover concerns during office visits, doctors can enter a referral directly in the electronic medical record.
Patients are “so relieved,” Dr. Auguste said in an interview, because they often wonder if their doctor can help. “Your doctor is only going to be able to help to a certain point. But to know they’re pregnant and they have this resource, and they’re going to get legal help, has been game-changing for so many patients.”
COVID ... or morning sickness?
In one rewarding case, Ms. Richardson said, a single mother of one child who was pregnant and experiencing hyperemesis explained that her employer would forbid her from working if she had any symptoms similar to COVID-19. The employer mistook her vomiting, nausea, and exhaustion as COVID symptoms and docked her pay. That started a cascade in which earning less meant she was facing eviction and car repossession – and, eventually, overdraft fees and withdrawals from her bank. She was so despondent she was thinking about self-harm, Ms. Richardson said.
With the aid of the P-LAW program, the woman had short-term disability approved within 72 hours, was referred to the hospital for inpatient mental health treatment, and received the care she needed. She ultimately delivered a healthy baby girl and found a new job.
Tiffany Moore Simas, MD, MPH, MEd, chair of the department of obstetrics and gynecology at the University of Massachusetts and UMass Memorial Health in Worcester, said she encounters similar concerns among her patients, with the vast majority having one or more issues with social determinants of health.
“I think it’s incredible, as we’re trying to address equity in perinatal health and maternal mortality and morbidity, to have a more holistic view of what health means, and all of the social determinants of health, and actually helping our patients address that in real time at their visits and connecting them,” said Dr. Simas, who also is professor of ob/gyn, pediatrics, psychiatry, and population and quantitative health sciences at UMass. “It has really opened my mind to the possibilities of things we need to explore and do differently.”
Ms. Richardson, Dr. Auguste, and Dr. Simas reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
BALTIMORE – A novel partnership between a legal services program and a maternal health clinic is helping pregnant patients with issues such as housing or employment discrimination.
The Perinatal Legal Assistance and Well-being (P-LAW) program at Georgetown University, Washington, launched 2 years ago as a collaboration between GU’s Health Justice Alliance clinic and the Women’s and Infants Services division of nearby MedStar Washington Hospital Center, integrating attorneys into the health care team to offer no-cost legal aid for its diverse, urban population during the perinatal period. Since then, the effort has assisted more than 120 women.
“Our goal was to see how integrating a lawyer can help address some of those issues that, unfortunately, providers are not able to assist with because they go beyond the hospital or clinic walls,” said Roxana Richardson, JD, the project director and managing attorney for P-LAW, during a poster presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Our initial findings showed that there are issues that patients were facing that needed an intervention from an attorney. We trained the providers and social workers to identify these issues so that we could intervene.”
Improving health by tackling legal barriers
, Ms. Richardson said.
The program is one of few medical-legal partnerships specifically focused on the perinatal population. P-LAW is one component of a larger initiative at MedStar Health called DC Safe Babies Safe Moms. The initiative includes integrated mental health programming, treatment of health conditions that complicate pregnancy, assessments of social determinants of health, expanded support for lactation and nutrition, access to home visiting referrals, and extended postpartum follow-up. The work is supported through the A. James & Alice B. Clark Foundation.
Patients are evaluated for health-harming legal needs as part of a comprehensive social and behavioral health screening at their initial prenatal visit, 28-week appointment, and postpartum visit. Those who screen positive are contacted by a referral specialist on the health care team who confirms the patient has an active legal need and would like to be connected to the P-LAW team. The team then reaches out to conduct a legal intake and determine the appropriate course of action.
From March 2021 through February of this year, Ms. Richardson and others with the program have provided legal representation to 123 patients on 186 legal issues in areas such as public benefits, employment, and housing and family concerns. Services range from advising patients on steps they can take on their own (like reporting a housing condition issue to the Department of Buildings), to sending letters on patients’ behalf, to appearing in court. Most patients served were in their second and third trimesters of pregnancy. The majority were Black or African American, aged 20-34 years, and had incomes below 100% of the federal poverty level.
The most common legal issues were in the areas of public benefits (SNAP/food stamps, cash assistance), employment (parental leave, discrimination), housing (conditions, eviction), and family law (child support, domestic violence). Among the 186 issues, work has been completed on 106 concerns and 33 still have a case open; for 47, the client withdrew or ceased contact, Ms. Richardson reported.
Most times when obstetricians hear concerns like these, they wonder what to do, said Tamika Auguste, MD, chair of obstetrics and gynecology at MedStar Health. Having the P-LAW program as a resource is a huge help, she said. If patients express concerns, or if obstetricians uncover concerns during office visits, doctors can enter a referral directly in the electronic medical record.
Patients are “so relieved,” Dr. Auguste said in an interview, because they often wonder if their doctor can help. “Your doctor is only going to be able to help to a certain point. But to know they’re pregnant and they have this resource, and they’re going to get legal help, has been game-changing for so many patients.”
COVID ... or morning sickness?
In one rewarding case, Ms. Richardson said, a single mother of one child who was pregnant and experiencing hyperemesis explained that her employer would forbid her from working if she had any symptoms similar to COVID-19. The employer mistook her vomiting, nausea, and exhaustion as COVID symptoms and docked her pay. That started a cascade in which earning less meant she was facing eviction and car repossession – and, eventually, overdraft fees and withdrawals from her bank. She was so despondent she was thinking about self-harm, Ms. Richardson said.
With the aid of the P-LAW program, the woman had short-term disability approved within 72 hours, was referred to the hospital for inpatient mental health treatment, and received the care she needed. She ultimately delivered a healthy baby girl and found a new job.
Tiffany Moore Simas, MD, MPH, MEd, chair of the department of obstetrics and gynecology at the University of Massachusetts and UMass Memorial Health in Worcester, said she encounters similar concerns among her patients, with the vast majority having one or more issues with social determinants of health.
“I think it’s incredible, as we’re trying to address equity in perinatal health and maternal mortality and morbidity, to have a more holistic view of what health means, and all of the social determinants of health, and actually helping our patients address that in real time at their visits and connecting them,” said Dr. Simas, who also is professor of ob/gyn, pediatrics, psychiatry, and population and quantitative health sciences at UMass. “It has really opened my mind to the possibilities of things we need to explore and do differently.”
Ms. Richardson, Dr. Auguste, and Dr. Simas reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
BALTIMORE – A novel partnership between a legal services program and a maternal health clinic is helping pregnant patients with issues such as housing or employment discrimination.
The Perinatal Legal Assistance and Well-being (P-LAW) program at Georgetown University, Washington, launched 2 years ago as a collaboration between GU’s Health Justice Alliance clinic and the Women’s and Infants Services division of nearby MedStar Washington Hospital Center, integrating attorneys into the health care team to offer no-cost legal aid for its diverse, urban population during the perinatal period. Since then, the effort has assisted more than 120 women.
“Our goal was to see how integrating a lawyer can help address some of those issues that, unfortunately, providers are not able to assist with because they go beyond the hospital or clinic walls,” said Roxana Richardson, JD, the project director and managing attorney for P-LAW, during a poster presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “Our initial findings showed that there are issues that patients were facing that needed an intervention from an attorney. We trained the providers and social workers to identify these issues so that we could intervene.”
Improving health by tackling legal barriers
, Ms. Richardson said.
The program is one of few medical-legal partnerships specifically focused on the perinatal population. P-LAW is one component of a larger initiative at MedStar Health called DC Safe Babies Safe Moms. The initiative includes integrated mental health programming, treatment of health conditions that complicate pregnancy, assessments of social determinants of health, expanded support for lactation and nutrition, access to home visiting referrals, and extended postpartum follow-up. The work is supported through the A. James & Alice B. Clark Foundation.
Patients are evaluated for health-harming legal needs as part of a comprehensive social and behavioral health screening at their initial prenatal visit, 28-week appointment, and postpartum visit. Those who screen positive are contacted by a referral specialist on the health care team who confirms the patient has an active legal need and would like to be connected to the P-LAW team. The team then reaches out to conduct a legal intake and determine the appropriate course of action.
From March 2021 through February of this year, Ms. Richardson and others with the program have provided legal representation to 123 patients on 186 legal issues in areas such as public benefits, employment, and housing and family concerns. Services range from advising patients on steps they can take on their own (like reporting a housing condition issue to the Department of Buildings), to sending letters on patients’ behalf, to appearing in court. Most patients served were in their second and third trimesters of pregnancy. The majority were Black or African American, aged 20-34 years, and had incomes below 100% of the federal poverty level.
The most common legal issues were in the areas of public benefits (SNAP/food stamps, cash assistance), employment (parental leave, discrimination), housing (conditions, eviction), and family law (child support, domestic violence). Among the 186 issues, work has been completed on 106 concerns and 33 still have a case open; for 47, the client withdrew or ceased contact, Ms. Richardson reported.
Most times when obstetricians hear concerns like these, they wonder what to do, said Tamika Auguste, MD, chair of obstetrics and gynecology at MedStar Health. Having the P-LAW program as a resource is a huge help, she said. If patients express concerns, or if obstetricians uncover concerns during office visits, doctors can enter a referral directly in the electronic medical record.
Patients are “so relieved,” Dr. Auguste said in an interview, because they often wonder if their doctor can help. “Your doctor is only going to be able to help to a certain point. But to know they’re pregnant and they have this resource, and they’re going to get legal help, has been game-changing for so many patients.”
COVID ... or morning sickness?
In one rewarding case, Ms. Richardson said, a single mother of one child who was pregnant and experiencing hyperemesis explained that her employer would forbid her from working if she had any symptoms similar to COVID-19. The employer mistook her vomiting, nausea, and exhaustion as COVID symptoms and docked her pay. That started a cascade in which earning less meant she was facing eviction and car repossession – and, eventually, overdraft fees and withdrawals from her bank. She was so despondent she was thinking about self-harm, Ms. Richardson said.
With the aid of the P-LAW program, the woman had short-term disability approved within 72 hours, was referred to the hospital for inpatient mental health treatment, and received the care she needed. She ultimately delivered a healthy baby girl and found a new job.
Tiffany Moore Simas, MD, MPH, MEd, chair of the department of obstetrics and gynecology at the University of Massachusetts and UMass Memorial Health in Worcester, said she encounters similar concerns among her patients, with the vast majority having one or more issues with social determinants of health.
“I think it’s incredible, as we’re trying to address equity in perinatal health and maternal mortality and morbidity, to have a more holistic view of what health means, and all of the social determinants of health, and actually helping our patients address that in real time at their visits and connecting them,” said Dr. Simas, who also is professor of ob/gyn, pediatrics, psychiatry, and population and quantitative health sciences at UMass. “It has really opened my mind to the possibilities of things we need to explore and do differently.”
Ms. Richardson, Dr. Auguste, and Dr. Simas reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT ACOG 2023
Circulating tumor DNA may predict poor prognosis in breast cancer
a new meta-analysis and systematic review found.
“Circulating tumor DNA (ctDNA) has been extensively studied as a prognostic biomarker in early breast cancer. However, there is a significant heterogeneity in the study results, which is probably related to the fact that each individual study included different patient populations, collected blood at different time points, and used different methods (assays) for ctDNA analysis,” said Guilherme Nader Marta, MD, of the Institut Jules Bordet, Anderlecht, Belgium, in an interview.
“The aim of our study was to summarize the available evidence that has been presented so far on this topic by performing a systematic review and meta-analysis including studies that reported the association between ctDNA detection and long-term outcomes,” said Dr. Nader Marta, who coauthored the new research, which was presented as a poster (Poster 26P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
Methods and results
The authors identified 57 studies including data from 5,729 individuals with early breast cancer. The 44.5% for whom stages were reported consisted of 18.3% with stage I disease, 60.0% with stage II, and 21.5% with stage III. Patients’ ctDNA collection was divided into three groups: baseline, after neoadjuvant therapy (End-of-NAT), and during follow-up care; ctDNA assays were classified as tumor-informed or non–tumor-informed.
The detection of ctDNA at any time point during diagnosis and treatment was associated with worse disease-free survival (DFS) and overall survival (OS), compared with no ctDNA. The association was stronger in tumor-informed assays, the researchers said.
For disease-free survival, the overall multivariate hazard ratios were 2.5, 5.5, and 7.2 for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
For overall survival, the overall multivariate hazard ratios were 3.0, 12.9, and 5.6, for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
The pooled hazard ratios were numerically higher for both DFS and OS when ctDNA was detected at either End-of-NAT or follow-up.
In addition, detection of ctDNA was associated with a high degree of specificity (from 0.7 to 1.0) for breast cancer relapse; sensitivity ranged from 0.31 to 1.0, the researchers noted. The mean lead time from ctDNA detection to breast cancer recurrence in these cases was approximately 10 months.
Results show ctDNA detection is associated with worse survival
“Our study results demonstrate that ctDNA detection is associated with worse disease-free survival and overall survival in patients with early breast cancer, particularly when measured after treatment with tumor-informed assays,” Dr. Nader Marta said in an interview.
“As next steps, we need to build on this evidence to bring the potential benefits of this powerful prognostic tool to our patients,” said Dr. Nader Marta. “Ongoing studies exploring different management strategies based on serial ctDNA assessments will help us understand the exact role of this technology in our clinical practice.”
The study received no outside funding. Dr. Nader Marta disclosed relationships with companies including Roche and Bayer.
a new meta-analysis and systematic review found.
“Circulating tumor DNA (ctDNA) has been extensively studied as a prognostic biomarker in early breast cancer. However, there is a significant heterogeneity in the study results, which is probably related to the fact that each individual study included different patient populations, collected blood at different time points, and used different methods (assays) for ctDNA analysis,” said Guilherme Nader Marta, MD, of the Institut Jules Bordet, Anderlecht, Belgium, in an interview.
“The aim of our study was to summarize the available evidence that has been presented so far on this topic by performing a systematic review and meta-analysis including studies that reported the association between ctDNA detection and long-term outcomes,” said Dr. Nader Marta, who coauthored the new research, which was presented as a poster (Poster 26P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
Methods and results
The authors identified 57 studies including data from 5,729 individuals with early breast cancer. The 44.5% for whom stages were reported consisted of 18.3% with stage I disease, 60.0% with stage II, and 21.5% with stage III. Patients’ ctDNA collection was divided into three groups: baseline, after neoadjuvant therapy (End-of-NAT), and during follow-up care; ctDNA assays were classified as tumor-informed or non–tumor-informed.
The detection of ctDNA at any time point during diagnosis and treatment was associated with worse disease-free survival (DFS) and overall survival (OS), compared with no ctDNA. The association was stronger in tumor-informed assays, the researchers said.
For disease-free survival, the overall multivariate hazard ratios were 2.5, 5.5, and 7.2 for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
For overall survival, the overall multivariate hazard ratios were 3.0, 12.9, and 5.6, for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
The pooled hazard ratios were numerically higher for both DFS and OS when ctDNA was detected at either End-of-NAT or follow-up.
In addition, detection of ctDNA was associated with a high degree of specificity (from 0.7 to 1.0) for breast cancer relapse; sensitivity ranged from 0.31 to 1.0, the researchers noted. The mean lead time from ctDNA detection to breast cancer recurrence in these cases was approximately 10 months.
Results show ctDNA detection is associated with worse survival
“Our study results demonstrate that ctDNA detection is associated with worse disease-free survival and overall survival in patients with early breast cancer, particularly when measured after treatment with tumor-informed assays,” Dr. Nader Marta said in an interview.
“As next steps, we need to build on this evidence to bring the potential benefits of this powerful prognostic tool to our patients,” said Dr. Nader Marta. “Ongoing studies exploring different management strategies based on serial ctDNA assessments will help us understand the exact role of this technology in our clinical practice.”
The study received no outside funding. Dr. Nader Marta disclosed relationships with companies including Roche and Bayer.
a new meta-analysis and systematic review found.
“Circulating tumor DNA (ctDNA) has been extensively studied as a prognostic biomarker in early breast cancer. However, there is a significant heterogeneity in the study results, which is probably related to the fact that each individual study included different patient populations, collected blood at different time points, and used different methods (assays) for ctDNA analysis,” said Guilherme Nader Marta, MD, of the Institut Jules Bordet, Anderlecht, Belgium, in an interview.
“The aim of our study was to summarize the available evidence that has been presented so far on this topic by performing a systematic review and meta-analysis including studies that reported the association between ctDNA detection and long-term outcomes,” said Dr. Nader Marta, who coauthored the new research, which was presented as a poster (Poster 26P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
Methods and results
The authors identified 57 studies including data from 5,729 individuals with early breast cancer. The 44.5% for whom stages were reported consisted of 18.3% with stage I disease, 60.0% with stage II, and 21.5% with stage III. Patients’ ctDNA collection was divided into three groups: baseline, after neoadjuvant therapy (End-of-NAT), and during follow-up care; ctDNA assays were classified as tumor-informed or non–tumor-informed.
The detection of ctDNA at any time point during diagnosis and treatment was associated with worse disease-free survival (DFS) and overall survival (OS), compared with no ctDNA. The association was stronger in tumor-informed assays, the researchers said.
For disease-free survival, the overall multivariate hazard ratios were 2.5, 5.5, and 7.2 for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
For overall survival, the overall multivariate hazard ratios were 3.0, 12.9, and 5.6, for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
The pooled hazard ratios were numerically higher for both DFS and OS when ctDNA was detected at either End-of-NAT or follow-up.
In addition, detection of ctDNA was associated with a high degree of specificity (from 0.7 to 1.0) for breast cancer relapse; sensitivity ranged from 0.31 to 1.0, the researchers noted. The mean lead time from ctDNA detection to breast cancer recurrence in these cases was approximately 10 months.
Results show ctDNA detection is associated with worse survival
“Our study results demonstrate that ctDNA detection is associated with worse disease-free survival and overall survival in patients with early breast cancer, particularly when measured after treatment with tumor-informed assays,” Dr. Nader Marta said in an interview.
“As next steps, we need to build on this evidence to bring the potential benefits of this powerful prognostic tool to our patients,” said Dr. Nader Marta. “Ongoing studies exploring different management strategies based on serial ctDNA assessments will help us understand the exact role of this technology in our clinical practice.”
The study received no outside funding. Dr. Nader Marta disclosed relationships with companies including Roche and Bayer.
ESMO BREAST CANCER 2023
Scheduled bleeding may boost tolerability of hormone implants
BALTIMORE – The bleeding causes some women to have the device removed, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
In a randomized, double-blinded, placebo-controlled trial of 51 patients desiring the implants – which suppress ovulation by releasing progestin over a 3-year period – taking norethindrone acetate for 1 week every 4 weeks led to 80% of participants in the treatment group reporting satisfactory bleeding patterns with the etonogestrel implants in place.
Rates of early discontinuation have been variable, according to published literature, ranging from 13% to 21.1%, said Jordan Gray, MD, a fourth-year resident in ob.gyn. at Baylor Scott and White Medical Center, Temple, Tex., who helped conduct the new study. Reasons included bothersome bleeding. Dr. Gray and colleagues found that 24% of women in the placebo group requested removal of the implant, compared with 9% of those in the treatment group. Among these women, none requested removal for bothersome bleeding but rather for reasons such as wanting to get pregnant. One person requested removal because she did not like amenorrhea.
While the results of the study did not achieve statistical significance, owing to its size and noncompliance among some participants, it does indicate that norethindrone acetate may be helpful, Dr. Gray said.
During the study, participants in the treatment group (n = 22) received a monthly treatment regimen of 5 mg of oral norethindrone acetate daily for 7 days each month for the first 6 months after placement of an etonogestrel implant. The placebo group (n = 29) was given inert tablets prescribed in the same regimen. Both groups received products from a mail-order pharmacy.
Participants were women aged 18-48 years who desired an implant or those aged 14 years who had permission from a parent or guardian to receive the contraceptive. The study excluded people with known or suspected pregnancy, those less than 8 weeks’ post partum, those who experienced menarche less than 2 years ago, those with body mass index greater than 40, and those who received depot medroxyprogesterone acetate within the previous 12 weeks. Excessive bleeding was defined as bleeding or spotting on more than 7 consecutive days or a fifth episode of bleeding in 90 days.
Overall, 11 patients (38%) in the placebo group and 10 (45%) in the treatment arm withdrew from the study. Reasons included wanting to get pregnant, mood changes, or noncompliance with study parameters, which included not responding or returning bleeding diaries, Dr. Gray said.
A limitation of the study was that compliance was less than expected. In addition, there were challenges with rates of responses, Dr. Gray said. The study was conducted during the COVID-19 pandemic, when all in-person visits were transitioned to telehealth. Although the investigators offered payment to participants, not all returned text-message surveys. The researchers had intended to enroll 124 participants but curtailed the study early, owing to the limited number of participants.
Given that there is no standard approach to treating prolonged or excessive bleeding with etonogestrel implants, Dr. Gray said, “Our data suggests that this regimen is a simple and acceptable method to treat bothersome bleeding and that predictable bleeding may be more satisfactory than unpredictable bleeding.”
Veronica Maria Pimentel, MD, moderator of the session and a maternal-fetal medicine specialist and director of research for the ob.gyn. residency program at St. Francis Hospital, part of Trinity Health of New England in Hartford, Conn., praised the researchers for a well-designed study.
“However, unfortunately, they were not able to recruit the number of patients that they needed in order to achieve the power to show the difference [between treatment arms], so another study would have to be done to show if there is a difference,” Dr. Pimentel said.
Dr. Pimentel complimented Dr. Gray following her presentation, congratulating her for conducting a randomized, controlled trial: “That’s not easy, as you have shown, but it’s also a good try, so you can actually see how hard it is to obtain quality data from research.”
The study was supported in part by a research grant from the Investigator-Initiated Studies Program of Organon. Dr. Gray is a consultant for Johnson & Johnson. Dr. Pimentel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BALTIMORE – The bleeding causes some women to have the device removed, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
In a randomized, double-blinded, placebo-controlled trial of 51 patients desiring the implants – which suppress ovulation by releasing progestin over a 3-year period – taking norethindrone acetate for 1 week every 4 weeks led to 80% of participants in the treatment group reporting satisfactory bleeding patterns with the etonogestrel implants in place.
Rates of early discontinuation have been variable, according to published literature, ranging from 13% to 21.1%, said Jordan Gray, MD, a fourth-year resident in ob.gyn. at Baylor Scott and White Medical Center, Temple, Tex., who helped conduct the new study. Reasons included bothersome bleeding. Dr. Gray and colleagues found that 24% of women in the placebo group requested removal of the implant, compared with 9% of those in the treatment group. Among these women, none requested removal for bothersome bleeding but rather for reasons such as wanting to get pregnant. One person requested removal because she did not like amenorrhea.
While the results of the study did not achieve statistical significance, owing to its size and noncompliance among some participants, it does indicate that norethindrone acetate may be helpful, Dr. Gray said.
During the study, participants in the treatment group (n = 22) received a monthly treatment regimen of 5 mg of oral norethindrone acetate daily for 7 days each month for the first 6 months after placement of an etonogestrel implant. The placebo group (n = 29) was given inert tablets prescribed in the same regimen. Both groups received products from a mail-order pharmacy.
Participants were women aged 18-48 years who desired an implant or those aged 14 years who had permission from a parent or guardian to receive the contraceptive. The study excluded people with known or suspected pregnancy, those less than 8 weeks’ post partum, those who experienced menarche less than 2 years ago, those with body mass index greater than 40, and those who received depot medroxyprogesterone acetate within the previous 12 weeks. Excessive bleeding was defined as bleeding or spotting on more than 7 consecutive days or a fifth episode of bleeding in 90 days.
Overall, 11 patients (38%) in the placebo group and 10 (45%) in the treatment arm withdrew from the study. Reasons included wanting to get pregnant, mood changes, or noncompliance with study parameters, which included not responding or returning bleeding diaries, Dr. Gray said.
A limitation of the study was that compliance was less than expected. In addition, there were challenges with rates of responses, Dr. Gray said. The study was conducted during the COVID-19 pandemic, when all in-person visits were transitioned to telehealth. Although the investigators offered payment to participants, not all returned text-message surveys. The researchers had intended to enroll 124 participants but curtailed the study early, owing to the limited number of participants.
Given that there is no standard approach to treating prolonged or excessive bleeding with etonogestrel implants, Dr. Gray said, “Our data suggests that this regimen is a simple and acceptable method to treat bothersome bleeding and that predictable bleeding may be more satisfactory than unpredictable bleeding.”
Veronica Maria Pimentel, MD, moderator of the session and a maternal-fetal medicine specialist and director of research for the ob.gyn. residency program at St. Francis Hospital, part of Trinity Health of New England in Hartford, Conn., praised the researchers for a well-designed study.
“However, unfortunately, they were not able to recruit the number of patients that they needed in order to achieve the power to show the difference [between treatment arms], so another study would have to be done to show if there is a difference,” Dr. Pimentel said.
Dr. Pimentel complimented Dr. Gray following her presentation, congratulating her for conducting a randomized, controlled trial: “That’s not easy, as you have shown, but it’s also a good try, so you can actually see how hard it is to obtain quality data from research.”
The study was supported in part by a research grant from the Investigator-Initiated Studies Program of Organon. Dr. Gray is a consultant for Johnson & Johnson. Dr. Pimentel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BALTIMORE – The bleeding causes some women to have the device removed, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
In a randomized, double-blinded, placebo-controlled trial of 51 patients desiring the implants – which suppress ovulation by releasing progestin over a 3-year period – taking norethindrone acetate for 1 week every 4 weeks led to 80% of participants in the treatment group reporting satisfactory bleeding patterns with the etonogestrel implants in place.
Rates of early discontinuation have been variable, according to published literature, ranging from 13% to 21.1%, said Jordan Gray, MD, a fourth-year resident in ob.gyn. at Baylor Scott and White Medical Center, Temple, Tex., who helped conduct the new study. Reasons included bothersome bleeding. Dr. Gray and colleagues found that 24% of women in the placebo group requested removal of the implant, compared with 9% of those in the treatment group. Among these women, none requested removal for bothersome bleeding but rather for reasons such as wanting to get pregnant. One person requested removal because she did not like amenorrhea.
While the results of the study did not achieve statistical significance, owing to its size and noncompliance among some participants, it does indicate that norethindrone acetate may be helpful, Dr. Gray said.
During the study, participants in the treatment group (n = 22) received a monthly treatment regimen of 5 mg of oral norethindrone acetate daily for 7 days each month for the first 6 months after placement of an etonogestrel implant. The placebo group (n = 29) was given inert tablets prescribed in the same regimen. Both groups received products from a mail-order pharmacy.
Participants were women aged 18-48 years who desired an implant or those aged 14 years who had permission from a parent or guardian to receive the contraceptive. The study excluded people with known or suspected pregnancy, those less than 8 weeks’ post partum, those who experienced menarche less than 2 years ago, those with body mass index greater than 40, and those who received depot medroxyprogesterone acetate within the previous 12 weeks. Excessive bleeding was defined as bleeding or spotting on more than 7 consecutive days or a fifth episode of bleeding in 90 days.
Overall, 11 patients (38%) in the placebo group and 10 (45%) in the treatment arm withdrew from the study. Reasons included wanting to get pregnant, mood changes, or noncompliance with study parameters, which included not responding or returning bleeding diaries, Dr. Gray said.
A limitation of the study was that compliance was less than expected. In addition, there were challenges with rates of responses, Dr. Gray said. The study was conducted during the COVID-19 pandemic, when all in-person visits were transitioned to telehealth. Although the investigators offered payment to participants, not all returned text-message surveys. The researchers had intended to enroll 124 participants but curtailed the study early, owing to the limited number of participants.
Given that there is no standard approach to treating prolonged or excessive bleeding with etonogestrel implants, Dr. Gray said, “Our data suggests that this regimen is a simple and acceptable method to treat bothersome bleeding and that predictable bleeding may be more satisfactory than unpredictable bleeding.”
Veronica Maria Pimentel, MD, moderator of the session and a maternal-fetal medicine specialist and director of research for the ob.gyn. residency program at St. Francis Hospital, part of Trinity Health of New England in Hartford, Conn., praised the researchers for a well-designed study.
“However, unfortunately, they were not able to recruit the number of patients that they needed in order to achieve the power to show the difference [between treatment arms], so another study would have to be done to show if there is a difference,” Dr. Pimentel said.
Dr. Pimentel complimented Dr. Gray following her presentation, congratulating her for conducting a randomized, controlled trial: “That’s not easy, as you have shown, but it’s also a good try, so you can actually see how hard it is to obtain quality data from research.”
The study was supported in part by a research grant from the Investigator-Initiated Studies Program of Organon. Dr. Gray is a consultant for Johnson & Johnson. Dr. Pimentel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ACOG 2023
Once-daily nifedipine sufficient for hypertension in pregnancy
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*
The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.
“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.
Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.
Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose – the most common adjustment – and 20.7% needed both an increase in nifedipine and an additional medication.
The researchers observed no statistically significant differences in the proportion of patients who required a dose increase or an additional antihypertensive in the group taking the twice-daily dose (33.8%) or those receiving the once-daily dose (35.7%). This finding remained statistically insignificant after controlling for gestational diabetes, delivery mode, administration of Lasix, and receipt of emergency antihypertensive treatment (P = .71). The time that passed before patients needed a dose increase was also statistically similar between the groups: 24.3 hours in the twice-daily group and 24 hours in the once-daily group (P = .49).
There were no statistically significant differences in the need for a dose increase or an additional hypertensive agent based on race, ethnicity, body mass index, or history of preeclampsia as well. However, 24.5% of those taking the once-daily dosage had a history of preeclampsia, compared with 7.2% of those taking the twice-daily dosage (P < .001). Further, the median number of prior pregnancies was two in the twice-daily group versus three in the once-daily group (P = .002).
The authors found no significant difference between the two dosing groups in the need for emergency hypertensive treatment after reaching the study dose or in readmission for blood pressure control. In the twice-daily group, 21.6% of patients needed emergency antihypertensive treatment, compared with 14.3% in the once-daily group (P = .19). Readmission was necessary for 7.2% of the twice-daily group and 6.1% of the once-daily group (P > .99).
A subgroup analysis compared those who started nifedipine antepartum and those who started it post partum, but again, no significant difference in the dosing regimens existed.
Michael Ruma, MD, a maternal-fetal medicine specialist at Perinatal Associates of New Mexico in Albuquerque, was not involved in the study and said he welcomed the results.
“We have too many choices in medicine, so we need to just simplify the plan of attack,” reducing the number of things that clinicians need to think about, Dr. Ruma said in an interview. “A singular dose is always easiest for the patient, always easier for nursing staff, and usually, if you can optimize the dosing, that’s the best approach.”
Annabeth Brewton, MD, a resident at University of Tennessee, Knoxville, agreed, adding that new parents already have a lot going on immediately post partum.
“They’re going to be breastfeeding, they’re not sleeping, they’re going to forget to take that [second] dose,” Dr. Brewton said.
Ms. Band and Dr. Brewton had no disclosures. Dr. Ruma reported consulting and speaking for Hologic and consulting for Philips Ultrasound.
Correction, 5/24/23: An earlier version of this article misstated the daily doses of nifedipine. The study compared a
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*
The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.
“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.
Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.
Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose – the most common adjustment – and 20.7% needed both an increase in nifedipine and an additional medication.
The researchers observed no statistically significant differences in the proportion of patients who required a dose increase or an additional antihypertensive in the group taking the twice-daily dose (33.8%) or those receiving the once-daily dose (35.7%). This finding remained statistically insignificant after controlling for gestational diabetes, delivery mode, administration of Lasix, and receipt of emergency antihypertensive treatment (P = .71). The time that passed before patients needed a dose increase was also statistically similar between the groups: 24.3 hours in the twice-daily group and 24 hours in the once-daily group (P = .49).
There were no statistically significant differences in the need for a dose increase or an additional hypertensive agent based on race, ethnicity, body mass index, or history of preeclampsia as well. However, 24.5% of those taking the once-daily dosage had a history of preeclampsia, compared with 7.2% of those taking the twice-daily dosage (P < .001). Further, the median number of prior pregnancies was two in the twice-daily group versus three in the once-daily group (P = .002).
The authors found no significant difference between the two dosing groups in the need for emergency hypertensive treatment after reaching the study dose or in readmission for blood pressure control. In the twice-daily group, 21.6% of patients needed emergency antihypertensive treatment, compared with 14.3% in the once-daily group (P = .19). Readmission was necessary for 7.2% of the twice-daily group and 6.1% of the once-daily group (P > .99).
A subgroup analysis compared those who started nifedipine antepartum and those who started it post partum, but again, no significant difference in the dosing regimens existed.
Michael Ruma, MD, a maternal-fetal medicine specialist at Perinatal Associates of New Mexico in Albuquerque, was not involved in the study and said he welcomed the results.
“We have too many choices in medicine, so we need to just simplify the plan of attack,” reducing the number of things that clinicians need to think about, Dr. Ruma said in an interview. “A singular dose is always easiest for the patient, always easier for nursing staff, and usually, if you can optimize the dosing, that’s the best approach.”
Annabeth Brewton, MD, a resident at University of Tennessee, Knoxville, agreed, adding that new parents already have a lot going on immediately post partum.
“They’re going to be breastfeeding, they’re not sleeping, they’re going to forget to take that [second] dose,” Dr. Brewton said.
Ms. Band and Dr. Brewton had no disclosures. Dr. Ruma reported consulting and speaking for Hologic and consulting for Philips Ultrasound.
Correction, 5/24/23: An earlier version of this article misstated the daily doses of nifedipine. The study compared a
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*
The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.
“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.
Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.
Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose – the most common adjustment – and 20.7% needed both an increase in nifedipine and an additional medication.
The researchers observed no statistically significant differences in the proportion of patients who required a dose increase or an additional antihypertensive in the group taking the twice-daily dose (33.8%) or those receiving the once-daily dose (35.7%). This finding remained statistically insignificant after controlling for gestational diabetes, delivery mode, administration of Lasix, and receipt of emergency antihypertensive treatment (P = .71). The time that passed before patients needed a dose increase was also statistically similar between the groups: 24.3 hours in the twice-daily group and 24 hours in the once-daily group (P = .49).
There were no statistically significant differences in the need for a dose increase or an additional hypertensive agent based on race, ethnicity, body mass index, or history of preeclampsia as well. However, 24.5% of those taking the once-daily dosage had a history of preeclampsia, compared with 7.2% of those taking the twice-daily dosage (P < .001). Further, the median number of prior pregnancies was two in the twice-daily group versus three in the once-daily group (P = .002).
The authors found no significant difference between the two dosing groups in the need for emergency hypertensive treatment after reaching the study dose or in readmission for blood pressure control. In the twice-daily group, 21.6% of patients needed emergency antihypertensive treatment, compared with 14.3% in the once-daily group (P = .19). Readmission was necessary for 7.2% of the twice-daily group and 6.1% of the once-daily group (P > .99).
A subgroup analysis compared those who started nifedipine antepartum and those who started it post partum, but again, no significant difference in the dosing regimens existed.
Michael Ruma, MD, a maternal-fetal medicine specialist at Perinatal Associates of New Mexico in Albuquerque, was not involved in the study and said he welcomed the results.
“We have too many choices in medicine, so we need to just simplify the plan of attack,” reducing the number of things that clinicians need to think about, Dr. Ruma said in an interview. “A singular dose is always easiest for the patient, always easier for nursing staff, and usually, if you can optimize the dosing, that’s the best approach.”
Annabeth Brewton, MD, a resident at University of Tennessee, Knoxville, agreed, adding that new parents already have a lot going on immediately post partum.
“They’re going to be breastfeeding, they’re not sleeping, they’re going to forget to take that [second] dose,” Dr. Brewton said.
Ms. Band and Dr. Brewton had no disclosures. Dr. Ruma reported consulting and speaking for Hologic and consulting for Philips Ultrasound.
Correction, 5/24/23: An earlier version of this article misstated the daily doses of nifedipine. The study compared a
AT ACOG 2023