Women's Health

TOPLINE:

The frequency of follow-up after fertility-sparing surgery for cervical cancer can be tailored based on high-risk human papillomavirus (HPV) tests and cytology.

METHODOLOGY:

• Among patients with early-stage cervical cancer, the optimal follow-up strategy to detect recurrence after fertility-sparing surgery remains unclear. The authors wanted to find out if follow-up could be tailored to the patient’s risk for recurrence instead of using the current inefficient one-size-fits-all approach.
• The retrospective cohort study, which used data from the Netherlands Cancer Registry and the Dutch Nationwide Pathology Databank, included 1462 patients aged 18-40 years with early-stage cervical cancer who received fertility-sparing surgery (large loop excision of the transformation zone, conization, or trachelectomy) between 2000 and 2020.
• The primary endpoint was the cumulative incidence of recurrent cervical intraepithelial neoplasia grade 2 or worse (CIN2+), including recurrent cervical cancer.
• The authors stratified the likelihood of recurrence by cytology and high-risk HPV results at the first follow-up visit within 12 months of fertility-sparing surgery; they also compared the cumulative incidence of recurrence — the number of new cases divided by all at-risk individuals over a specific interval — at four timepoints in 2 years (6, 12, 18, and 24 months).

TAKEAWAY:

• Overall, the 10-year recurrence-free survival for CIN2+ was 89.3%. Patients with high-grade cytology at the first follow-up had worse 10-year recurrence-free survival for CIN2+ (43.1%) than those who had normal (92.1%) and low-grade cytology (84.6%). Similarly for HPV status, patients positive for high-risk HPV at the first follow-up had worse 10-year recurrence-free survival rates for CIN2+ (73.6%) than those negative for high-risk HPV (91.1%).
• Patients negative for both high-risk HPV and high-grade cytology 6-24 months after fertility-sparing surgery had a cumulative incidence of recurrence of 0.0%-0.7% within 6 months of follow-up compared with 0.0%-33.3% among patients negative for high-risk HPV but who had high-grade cytology.
• By contrast, patients positive for high-risk HPV but not high-grade cytology had a cumulative incidence of recurrence of 0.0%-15.4% within 6 months of any follow-up visit compared with 50.0%-100.0% among those with both high-risk HPV and high-grade cytology.
• Patients who remained free of high-risk HPV and high-grade cytology at their 6-month and 12-month follow-ups had no disease recurrence over the next 6 months.

IN PRACTICE:

“Patients who are negative for high-risk HPV with normal or low-grade cytology at 6-24 months after fertility-sparing surgery could be offered a prolonged follow-up interval of 6 months,” the authors concluded, adding that this “group comprises 80% of all patients receiving fertility-sparing surgery.”

“Reducing the number of follow-up visits, and subsequently the number of follow-up tests, in patients with low risk for recurrence on the basis of co-testing has the potential to substantially reduce healthcare costs,” the authors explained.

SOURCE:

The study, led by Teska N. Schuurman, MD, of the Netherlands Cancer Institute, Amsterdam, was published in the December 2023 issue of The Lancet Oncology.

LIMITATIONS:

The retrospective design of the study meant that analysis was limited to available records, so data on patients’ symptoms, physical examinations, or colposcopic findings were not available. Follow-up biopsies, considered the gold standard for diagnosing recurrence, are not routine in the Netherlands, so recurrence could have been underreported.

DISCLOSURES:

The authors declared no competing interests.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The frequency of follow-up after fertility-sparing surgery for cervical cancer can be tailored based on high-risk human papillomavirus (HPV) tests and cytology.

METHODOLOGY:

• Among patients with early-stage cervical cancer, the optimal follow-up strategy to detect recurrence after fertility-sparing surgery remains unclear. The authors wanted to find out if follow-up could be tailored to the patient’s risk for recurrence instead of using the current inefficient one-size-fits-all approach.
• The retrospective cohort study, which used data from the Netherlands Cancer Registry and the Dutch Nationwide Pathology Databank, included 1462 patients aged 18-40 years with early-stage cervical cancer who received fertility-sparing surgery (large loop excision of the transformation zone, conization, or trachelectomy) between 2000 and 2020.
• The primary endpoint was the cumulative incidence of recurrent cervical intraepithelial neoplasia grade 2 or worse (CIN2+), including recurrent cervical cancer.
• The authors stratified the likelihood of recurrence by cytology and high-risk HPV results at the first follow-up visit within 12 months of fertility-sparing surgery; they also compared the cumulative incidence of recurrence — the number of new cases divided by all at-risk individuals over a specific interval — at four timepoints in 2 years (6, 12, 18, and 24 months).

TAKEAWAY:

• Overall, the 10-year recurrence-free survival for CIN2+ was 89.3%. Patients with high-grade cytology at the first follow-up had worse 10-year recurrence-free survival for CIN2+ (43.1%) than those who had normal (92.1%) and low-grade cytology (84.6%). Similarly for HPV status, patients positive for high-risk HPV at the first follow-up had worse 10-year recurrence-free survival rates for CIN2+ (73.6%) than those negative for high-risk HPV (91.1%).
• Patients negative for both high-risk HPV and high-grade cytology 6-24 months after fertility-sparing surgery had a cumulative incidence of recurrence of 0.0%-0.7% within 6 months of follow-up compared with 0.0%-33.3% among patients negative for high-risk HPV but who had high-grade cytology.
• By contrast, patients positive for high-risk HPV but not high-grade cytology had a cumulative incidence of recurrence of 0.0%-15.4% within 6 months of any follow-up visit compared with 50.0%-100.0% among those with both high-risk HPV and high-grade cytology.
• Patients who remained free of high-risk HPV and high-grade cytology at their 6-month and 12-month follow-ups had no disease recurrence over the next 6 months.

IN PRACTICE:

“Patients who are negative for high-risk HPV with normal or low-grade cytology at 6-24 months after fertility-sparing surgery could be offered a prolonged follow-up interval of 6 months,” the authors concluded, adding that this “group comprises 80% of all patients receiving fertility-sparing surgery.”

“Reducing the number of follow-up visits, and subsequently the number of follow-up tests, in patients with low risk for recurrence on the basis of co-testing has the potential to substantially reduce healthcare costs,” the authors explained.

SOURCE:

The study, led by Teska N. Schuurman, MD, of the Netherlands Cancer Institute, Amsterdam, was published in the December 2023 issue of The Lancet Oncology.

LIMITATIONS:

The retrospective design of the study meant that analysis was limited to available records, so data on patients’ symptoms, physical examinations, or colposcopic findings were not available. Follow-up biopsies, considered the gold standard for diagnosing recurrence, are not routine in the Netherlands, so recurrence could have been underreported.

DISCLOSURES:

The authors declared no competing interests.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The frequency of follow-up after fertility-sparing surgery for cervical cancer can be tailored based on high-risk human papillomavirus (HPV) tests and cytology.

METHODOLOGY:

• Among patients with early-stage cervical cancer, the optimal follow-up strategy to detect recurrence after fertility-sparing surgery remains unclear. The authors wanted to find out if follow-up could be tailored to the patient’s risk for recurrence instead of using the current inefficient one-size-fits-all approach.
• The retrospective cohort study, which used data from the Netherlands Cancer Registry and the Dutch Nationwide Pathology Databank, included 1462 patients aged 18-40 years with early-stage cervical cancer who received fertility-sparing surgery (large loop excision of the transformation zone, conization, or trachelectomy) between 2000 and 2020.
• The primary endpoint was the cumulative incidence of recurrent cervical intraepithelial neoplasia grade 2 or worse (CIN2+), including recurrent cervical cancer.
• The authors stratified the likelihood of recurrence by cytology and high-risk HPV results at the first follow-up visit within 12 months of fertility-sparing surgery; they also compared the cumulative incidence of recurrence — the number of new cases divided by all at-risk individuals over a specific interval — at four timepoints in 2 years (6, 12, 18, and 24 months).

TAKEAWAY:

• Overall, the 10-year recurrence-free survival for CIN2+ was 89.3%. Patients with high-grade cytology at the first follow-up had worse 10-year recurrence-free survival for CIN2+ (43.1%) than those who had normal (92.1%) and low-grade cytology (84.6%). Similarly for HPV status, patients positive for high-risk HPV at the first follow-up had worse 10-year recurrence-free survival rates for CIN2+ (73.6%) than those negative for high-risk HPV (91.1%).
• Patients negative for both high-risk HPV and high-grade cytology 6-24 months after fertility-sparing surgery had a cumulative incidence of recurrence of 0.0%-0.7% within 6 months of follow-up compared with 0.0%-33.3% among patients negative for high-risk HPV but who had high-grade cytology.
• By contrast, patients positive for high-risk HPV but not high-grade cytology had a cumulative incidence of recurrence of 0.0%-15.4% within 6 months of any follow-up visit compared with 50.0%-100.0% among those with both high-risk HPV and high-grade cytology.
• Patients who remained free of high-risk HPV and high-grade cytology at their 6-month and 12-month follow-ups had no disease recurrence over the next 6 months.

IN PRACTICE:

“Patients who are negative for high-risk HPV with normal or low-grade cytology at 6-24 months after fertility-sparing surgery could be offered a prolonged follow-up interval of 6 months,” the authors concluded, adding that this “group comprises 80% of all patients receiving fertility-sparing surgery.”

“Reducing the number of follow-up visits, and subsequently the number of follow-up tests, in patients with low risk for recurrence on the basis of co-testing has the potential to substantially reduce healthcare costs,” the authors explained.

SOURCE:

The study, led by Teska N. Schuurman, MD, of the Netherlands Cancer Institute, Amsterdam, was published in the December 2023 issue of The Lancet Oncology.

LIMITATIONS:

The retrospective design of the study meant that analysis was limited to available records, so data on patients’ symptoms, physical examinations, or colposcopic findings were not available. Follow-up biopsies, considered the gold standard for diagnosing recurrence, are not routine in the Netherlands, so recurrence could have been underreported.

DISCLOSURES:

The authors declared no competing interests.
 

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Network Open on the subject of whether statin therapy may be able to offset some of the excess risk for venous thromboembolism (VTE) among women taking menopausal hormone therapy.

It’s an important issue because we know that menopausal hormone therapy, especially oral therapy, is linked to an excess risk for VTE, approximately doubling of risk in the randomized clinical trials. There is also emerging evidence from some randomized trials, such as the Jupiter trial, that step therapy may be linked to a reduction in risk. This may be related to anti-inflammatory or antithrombotic effects of statin therapy.

The authors made use of a very large administrative claims database, Optum Health, to look at more than 15 million annual members. They were able to identify 2000 women with a diagnostic code for VTE treatment. The women were between ages 50 and 64 years, and they were compared with 200,000 controls without VTE, matched in 10-to-1 fashion.

About 50% of the women were taking oral hormone therapy, and about 50% took non-oral transdermal or other non-oral formulations of hormone therapy. The odds ratio for VTE was 1.53 among the women who did not also have prescription records for statin therapy. They were able to look at prescribed prescriptions for both the hormone therapy and the statins. Among the women prescribed hormone therapy and also low- to intermediate-dose statins, the odds ratio was 1.29. So that was quite a mitigation of the elevated risk. Among the women taking high-intensity statins, the odds ratio was 1.06, and there was no significant elevation.

We do need more data and more research on this question. One approach would be a meta-analysis of all of the existing randomized trials of hormone therapy in recent years wherein there was increased uptake of statin therapy to look at this question not only for VTE but also for coronary heart disease, stroke, and other CVD outcomes to see whether statin therapy is associated with some attenuation of the excess risk. We also need a targeted randomized trial of statins vs placebo among women who have clear indications for hormone therapy but may be at some increased risk for VTE. That type of trial would be extremely helpful.

In the interim, there are ways to minimize risk for VTE among women who are clear candidates for menopausal hormone therapy, especially among women at increased risk for VTE. These include choosing a transdermal rather than an oral formulation of hormone therapy and using lower doses of hormone therapy. Also, women who are clear candidates for hormone therapy and also for statins, it’s obvious that statins could be co-prescribed. Even among women who are clear candidates for hormone therapy but only intermediate borderline candidates for statin therapy, the prescription of statins might be considered in that clinical scenario to try to mitigate that excess risk for VTE.

JoAnn E. Manson, MD, DrPH, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from: Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Network Open on the subject of whether statin therapy may be able to offset some of the excess risk for venous thromboembolism (VTE) among women taking menopausal hormone therapy.

It’s an important issue because we know that menopausal hormone therapy, especially oral therapy, is linked to an excess risk for VTE, approximately doubling of risk in the randomized clinical trials. There is also emerging evidence from some randomized trials, such as the Jupiter trial, that step therapy may be linked to a reduction in risk. This may be related to anti-inflammatory or antithrombotic effects of statin therapy.

The authors made use of a very large administrative claims database, Optum Health, to look at more than 15 million annual members. They were able to identify 2000 women with a diagnostic code for VTE treatment. The women were between ages 50 and 64 years, and they were compared with 200,000 controls without VTE, matched in 10-to-1 fashion.

About 50% of the women were taking oral hormone therapy, and about 50% took non-oral transdermal or other non-oral formulations of hormone therapy. The odds ratio for VTE was 1.53 among the women who did not also have prescription records for statin therapy. They were able to look at prescribed prescriptions for both the hormone therapy and the statins. Among the women prescribed hormone therapy and also low- to intermediate-dose statins, the odds ratio was 1.29. So that was quite a mitigation of the elevated risk. Among the women taking high-intensity statins, the odds ratio was 1.06, and there was no significant elevation.

We do need more data and more research on this question. One approach would be a meta-analysis of all of the existing randomized trials of hormone therapy in recent years wherein there was increased uptake of statin therapy to look at this question not only for VTE but also for coronary heart disease, stroke, and other CVD outcomes to see whether statin therapy is associated with some attenuation of the excess risk. We also need a targeted randomized trial of statins vs placebo among women who have clear indications for hormone therapy but may be at some increased risk for VTE. That type of trial would be extremely helpful.

In the interim, there are ways to minimize risk for VTE among women who are clear candidates for menopausal hormone therapy, especially among women at increased risk for VTE. These include choosing a transdermal rather than an oral formulation of hormone therapy and using lower doses of hormone therapy. Also, women who are clear candidates for hormone therapy and also for statins, it’s obvious that statins could be co-prescribed. Even among women who are clear candidates for hormone therapy but only intermediate borderline candidates for statin therapy, the prescription of statins might be considered in that clinical scenario to try to mitigate that excess risk for VTE.

JoAnn E. Manson, MD, DrPH, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from: Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Network Open on the subject of whether statin therapy may be able to offset some of the excess risk for venous thromboembolism (VTE) among women taking menopausal hormone therapy.

It’s an important issue because we know that menopausal hormone therapy, especially oral therapy, is linked to an excess risk for VTE, approximately doubling of risk in the randomized clinical trials. There is also emerging evidence from some randomized trials, such as the Jupiter trial, that step therapy may be linked to a reduction in risk. This may be related to anti-inflammatory or antithrombotic effects of statin therapy.

The authors made use of a very large administrative claims database, Optum Health, to look at more than 15 million annual members. They were able to identify 2000 women with a diagnostic code for VTE treatment. The women were between ages 50 and 64 years, and they were compared with 200,000 controls without VTE, matched in 10-to-1 fashion.

About 50% of the women were taking oral hormone therapy, and about 50% took non-oral transdermal or other non-oral formulations of hormone therapy. The odds ratio for VTE was 1.53 among the women who did not also have prescription records for statin therapy. They were able to look at prescribed prescriptions for both the hormone therapy and the statins. Among the women prescribed hormone therapy and also low- to intermediate-dose statins, the odds ratio was 1.29. So that was quite a mitigation of the elevated risk. Among the women taking high-intensity statins, the odds ratio was 1.06, and there was no significant elevation.

We do need more data and more research on this question. One approach would be a meta-analysis of all of the existing randomized trials of hormone therapy in recent years wherein there was increased uptake of statin therapy to look at this question not only for VTE but also for coronary heart disease, stroke, and other CVD outcomes to see whether statin therapy is associated with some attenuation of the excess risk. We also need a targeted randomized trial of statins vs placebo among women who have clear indications for hormone therapy but may be at some increased risk for VTE. That type of trial would be extremely helpful.

In the interim, there are ways to minimize risk for VTE among women who are clear candidates for menopausal hormone therapy, especially among women at increased risk for VTE. These include choosing a transdermal rather than an oral formulation of hormone therapy and using lower doses of hormone therapy. Also, women who are clear candidates for hormone therapy and also for statins, it’s obvious that statins could be co-prescribed. Even among women who are clear candidates for hormone therapy but only intermediate borderline candidates for statin therapy, the prescription of statins might be considered in that clinical scenario to try to mitigate that excess risk for VTE.

JoAnn E. Manson, MD, DrPH, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from: Mars Symbioscience (for the COSMOS trial).

A version of this article appeared on Medscape.com.

TOPLINE:

Women with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative invasive lobular carcinoma who are treated with endocrine therapy do not derive any additional survival benefit from neoadjuvant or adjuvant chemotherapy.

METHODOLOGY:

• Studies evaluating the long-term effects of chemotherapy in patients with invasive lobular carcinoma are limited and often “show inconclusive results,” the authors explained.
• Female patients diagnosed with ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy were identified from the breast cancer database at Erasmus Medical Center, Rotterdam, the Netherlands.
• Linked information on patient and tumor characteristics, vital status, and treatment were then obtained from the Netherlands Cancer Registry.
• Patients also had to have an indication for chemotherapy based on lymph node status, tumor size, histologic tumor grade, and hormone receptor status, in line with national guidelines.
• Among 716 patients with ER-positive, HER2-negative invasive lobular carcinoma, 520 who had an indication for chemotherapy were included. Of those, 379 received chemotherapy and 141 did not.

TAKEAWAY:

• Patients who received chemotherapy were younger at diagnosis than those who did not (51 vs 61 years), had an earlier average year of diagnosis (2010 vs 2015), and had longer follow-up (7.8 years vs 5.2 years).
• Chemotherapy recipients were more likely to have T3+ disease (33% vs 14%) and positive lymph node involvement (80% vs 49%), and less likely to undergo breast-conserving surgery (31% vs 43%).
• Researchers, however, found no difference between the chemotherapy and no-chemotherapy groups in terms of recurrence-free survival (hazard ratio [HR], 1.20; 95% CI, 0.63-2.31), breast cancer–specific survival (HR, 1.24; 95% CI, 0.60-2.58), and overall survival (HR, 0.97; 95% CI, 0.56-1.66) after adjustment for confounders.

IN PRACTICE:

The authors “observed no evidence for added value of chemotherapy” for ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy. “In view of the adverse effects of chemotherapy, our study takes an important step in answering a valuable question from the patient’s perspective,” the researchers wrote.

SOURCE:

The study, conducted by Bernadette A.M. Heemskerk-Gerritsen, PhD, from Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands, was published in Cancer on November 20, 2023.

LIMITATIONS:

The retrospective design means that there is a risk for residual confounding from factors not recorded in the database. The researchers believe that some patients did not receive chemotherapy owing to having comorbidities or patient preference, which could have influenced the results. Moreover, the duration of endocrine therapy was not recorded.

DISCLOSURES:

No funding was declared. One author declares relationships with GlaxoSmithKline, Pfizer, Menarini Silicon Biosystems, and Novartis. No other relevant financial relationships were declared.

TOPLINE:

Women with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative invasive lobular carcinoma who are treated with endocrine therapy do not derive any additional survival benefit from neoadjuvant or adjuvant chemotherapy.

METHODOLOGY:

• Studies evaluating the long-term effects of chemotherapy in patients with invasive lobular carcinoma are limited and often “show inconclusive results,” the authors explained.
• Female patients diagnosed with ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy were identified from the breast cancer database at Erasmus Medical Center, Rotterdam, the Netherlands.
• Linked information on patient and tumor characteristics, vital status, and treatment were then obtained from the Netherlands Cancer Registry.
• Patients also had to have an indication for chemotherapy based on lymph node status, tumor size, histologic tumor grade, and hormone receptor status, in line with national guidelines.
• Among 716 patients with ER-positive, HER2-negative invasive lobular carcinoma, 520 who had an indication for chemotherapy were included. Of those, 379 received chemotherapy and 141 did not.

TAKEAWAY:

• Patients who received chemotherapy were younger at diagnosis than those who did not (51 vs 61 years), had an earlier average year of diagnosis (2010 vs 2015), and had longer follow-up (7.8 years vs 5.2 years).
• Chemotherapy recipients were more likely to have T3+ disease (33% vs 14%) and positive lymph node involvement (80% vs 49%), and less likely to undergo breast-conserving surgery (31% vs 43%).
• Researchers, however, found no difference between the chemotherapy and no-chemotherapy groups in terms of recurrence-free survival (hazard ratio [HR], 1.20; 95% CI, 0.63-2.31), breast cancer–specific survival (HR, 1.24; 95% CI, 0.60-2.58), and overall survival (HR, 0.97; 95% CI, 0.56-1.66) after adjustment for confounders.

IN PRACTICE:

The authors “observed no evidence for added value of chemotherapy” for ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy. “In view of the adverse effects of chemotherapy, our study takes an important step in answering a valuable question from the patient’s perspective,” the researchers wrote.

SOURCE:

The study, conducted by Bernadette A.M. Heemskerk-Gerritsen, PhD, from Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands, was published in Cancer on November 20, 2023.

LIMITATIONS:

The retrospective design means that there is a risk for residual confounding from factors not recorded in the database. The researchers believe that some patients did not receive chemotherapy owing to having comorbidities or patient preference, which could have influenced the results. Moreover, the duration of endocrine therapy was not recorded.

DISCLOSURES:

No funding was declared. One author declares relationships with GlaxoSmithKline, Pfizer, Menarini Silicon Biosystems, and Novartis. No other relevant financial relationships were declared.

TOPLINE:

Women with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative invasive lobular carcinoma who are treated with endocrine therapy do not derive any additional survival benefit from neoadjuvant or adjuvant chemotherapy.

METHODOLOGY:

• Studies evaluating the long-term effects of chemotherapy in patients with invasive lobular carcinoma are limited and often “show inconclusive results,” the authors explained.
• Female patients diagnosed with ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy were identified from the breast cancer database at Erasmus Medical Center, Rotterdam, the Netherlands.
• Linked information on patient and tumor characteristics, vital status, and treatment were then obtained from the Netherlands Cancer Registry.
• Patients also had to have an indication for chemotherapy based on lymph node status, tumor size, histologic tumor grade, and hormone receptor status, in line with national guidelines.
• Among 716 patients with ER-positive, HER2-negative invasive lobular carcinoma, 520 who had an indication for chemotherapy were included. Of those, 379 received chemotherapy and 141 did not.

TAKEAWAY:

• Patients who received chemotherapy were younger at diagnosis than those who did not (51 vs 61 years), had an earlier average year of diagnosis (2010 vs 2015), and had longer follow-up (7.8 years vs 5.2 years).
• Chemotherapy recipients were more likely to have T3+ disease (33% vs 14%) and positive lymph node involvement (80% vs 49%), and less likely to undergo breast-conserving surgery (31% vs 43%).
• Researchers, however, found no difference between the chemotherapy and no-chemotherapy groups in terms of recurrence-free survival (hazard ratio [HR], 1.20; 95% CI, 0.63-2.31), breast cancer–specific survival (HR, 1.24; 95% CI, 0.60-2.58), and overall survival (HR, 0.97; 95% CI, 0.56-1.66) after adjustment for confounders.

IN PRACTICE:

The authors “observed no evidence for added value of chemotherapy” for ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy. “In view of the adverse effects of chemotherapy, our study takes an important step in answering a valuable question from the patient’s perspective,” the researchers wrote.

SOURCE:

The study, conducted by Bernadette A.M. Heemskerk-Gerritsen, PhD, from Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands, was published in Cancer on November 20, 2023.

LIMITATIONS:

The retrospective design means that there is a risk for residual confounding from factors not recorded in the database. The researchers believe that some patients did not receive chemotherapy owing to having comorbidities or patient preference, which could have influenced the results. Moreover, the duration of endocrine therapy was not recorded.

DISCLOSURES:

No funding was declared. One author declares relationships with GlaxoSmithKline, Pfizer, Menarini Silicon Biosystems, and Novartis. No other relevant financial relationships were declared.

The past year has been a challenging time for many, both at the local level and globally, with divisive undercurrents across many communities. Many times, the end of the year is an opportunity for reflection. As I reflect on the state of perinatal psychiatry in the new year, I see several evolving issues that I’d like to share in this first column of 2024.

In 2023, the American College of Obstetricians and Gynecologists published new recommendations meant to enhance the well-being of pregnant and postpartum women and families. A main message from discussion papers borne out of these recommendations was that as a field, we should be doing more than identifying perinatal illness. We should be screening women at risk for postpartum psychiatric illness and see that those suffering from posttraumatic stress disorder (PTSD) have access to care and “wrap-around services” from clinicians with varying expertise.

Screening is a primary way we identify patients at risk for psychiatric illness and also those who are suffering at the time of a screen. One problem I see in the near future is our disparate collection and management of data. When we look closely across health care systems, it’s not clear how screening data are captured, let alone managed. What is being done in one hospital system may be very different from what is being done elsewhere. Some clinicians are adopting digital platforms to identify those with postpartum depression, while others are practicing as they always have, either through a paper screening process or with queries as part of a clinical encounter.

Given this amalgam of methods for collecting and storing information, there does not appear to be a systematic way clinicians and researchers are recording whether women are meeting criteria for significant depressive symptoms or frank postpartum psychiatric illness. It is clear a more cohesive method for collection and management is needed to optimize the likelihood that next steps can be taken to get patients the care they need.

However, screening is only one part of the story. Certainly, in our own center, one of our greatest interests, both clinically and on the research side, is what happens after screening. Through our center’s initiation of the Screening and Treatment Enhancement for Postpartum Depression (STEPS for PPD) project funded by the Marriott Foundation, we are evaluating the outcomes of women who are screened at 6 weeks postpartum with significant depressive symptoms, and who are then given an opportunity to engage with a perinatal social worker who can assist with direct psychotherapy, arranging for referrals, and navigating care for a new mother.

What we are learning as we enroll women through the initial stages of STEPS for PPD is that screening and identifying women who likely suffer from PPD simply is not enough. In fact, once identified with a depression screening tool, women who are suffering from postpartum depression can be very challenging to engage clinically. What I am learning decades after starting to work with perinatal patients is that even with a screening system and effective tools for treatment of PPD, optimizing engagement with these depressed women seems a critical and understudied step on the road to optimizing positive clinical outcomes.

A recent study published in the Journal of Women’s Health explored gaps in care for perinatal depression and found that patients without a history of psychiatric illness prior to pregnancy were less likely to be screened for depression and 80% less likely to receive care if they developed depression compared with women with a previous history of psychiatric illness (J Womens Health (Larchmt). 2023 Oct;32[10]:1111-9).

That history may help women navigate to care, while women for whom psychiatric illness is a new experience may be less likely to engage, be referred for care, and receive appropriate treatment. The study indicates that, as a field, we must strive to ensure universal screening for depression in perinatal populations.

While we have always been particularly interested in populations of patients at highest risk for PPD, helping women at risk for PPD in the general population without a history of psychiatric illness is a large public health issue and will be an even larger undertaking. As women’s mental health is gaining more appropriate focus, both at the local level and even in the recent White House Initiative on Women’s Health Research, the focus has been on screening and developing new treatments.

We are not lacking in pharmacologic agents nor nonpharmacologic options as treatments for women experiencing PPD. Newer alternative treatments are being explored, such as transcranial magnetic stimulation (TMS) and even psychedelics as a potential therapy for PPD. But perhaps what we’ve learned in 2023 and as we move into a new year, is that the problem of tackling PPD is not only about having the right tools, but is about helping women navigate to the care that they need.

The COVID-19 pandemic brought with it an explosion of telehealth options that have enhanced the odds women can find support during such a challenging time; as society has returned to some semblance of normal, nearly all support groups for postpartum women have remained online.

When we set up Virtual Rounds at the Center for Women’s Mental Health at the beginning of the pandemic, I was struck by the community of colleagues at various stages of their careers dedicated to mitigating the suffering associated with perinatal psychiatric illness. As I’ve often said, it takes a village to care for these patients. We need help from colleagues with varying expertise — from lactation consultants, psychiatrists, psychologists, obstetricians, nurse practitioners, support group leaders, and a host of others — who can help reach these women.

At the end of the day, helping depressed women find resources is a challenge that we have not met in this country. We should be excited that we have so many treatment options to offer patients — whether it be a new first-in-class medication, TMS, or digital apps to ensure patients are receiving effective treatment. But there should also be a focus on reaching women who still need treatment, particularly in underserved communities where resources are sparse or nonexistent. Identifying the path to reaching these women where they are and getting them well should be a top priority in 2024.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. STEPS for PPD is funded by the Marriott Foundation. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

The past year has been a challenging time for many, both at the local level and globally, with divisive undercurrents across many communities. Many times, the end of the year is an opportunity for reflection. As I reflect on the state of perinatal psychiatry in the new year, I see several evolving issues that I’d like to share in this first column of 2024.

In 2023, the American College of Obstetricians and Gynecologists published new recommendations meant to enhance the well-being of pregnant and postpartum women and families. A main message from discussion papers borne out of these recommendations was that as a field, we should be doing more than identifying perinatal illness. We should be screening women at risk for postpartum psychiatric illness and see that those suffering from posttraumatic stress disorder (PTSD) have access to care and “wrap-around services” from clinicians with varying expertise.

Screening is a primary way we identify patients at risk for psychiatric illness and also those who are suffering at the time of a screen. One problem I see in the near future is our disparate collection and management of data. When we look closely across health care systems, it’s not clear how screening data are captured, let alone managed. What is being done in one hospital system may be very different from what is being done elsewhere. Some clinicians are adopting digital platforms to identify those with postpartum depression, while others are practicing as they always have, either through a paper screening process or with queries as part of a clinical encounter.

Given this amalgam of methods for collecting and storing information, there does not appear to be a systematic way clinicians and researchers are recording whether women are meeting criteria for significant depressive symptoms or frank postpartum psychiatric illness. It is clear a more cohesive method for collection and management is needed to optimize the likelihood that next steps can be taken to get patients the care they need.

However, screening is only one part of the story. Certainly, in our own center, one of our greatest interests, both clinically and on the research side, is what happens after screening. Through our center’s initiation of the Screening and Treatment Enhancement for Postpartum Depression (STEPS for PPD) project funded by the Marriott Foundation, we are evaluating the outcomes of women who are screened at 6 weeks postpartum with significant depressive symptoms, and who are then given an opportunity to engage with a perinatal social worker who can assist with direct psychotherapy, arranging for referrals, and navigating care for a new mother.

What we are learning as we enroll women through the initial stages of STEPS for PPD is that screening and identifying women who likely suffer from PPD simply is not enough. In fact, once identified with a depression screening tool, women who are suffering from postpartum depression can be very challenging to engage clinically. What I am learning decades after starting to work with perinatal patients is that even with a screening system and effective tools for treatment of PPD, optimizing engagement with these depressed women seems a critical and understudied step on the road to optimizing positive clinical outcomes.

A recent study published in the Journal of Women’s Health explored gaps in care for perinatal depression and found that patients without a history of psychiatric illness prior to pregnancy were less likely to be screened for depression and 80% less likely to receive care if they developed depression compared with women with a previous history of psychiatric illness (J Womens Health (Larchmt). 2023 Oct;32[10]:1111-9).

That history may help women navigate to care, while women for whom psychiatric illness is a new experience may be less likely to engage, be referred for care, and receive appropriate treatment. The study indicates that, as a field, we must strive to ensure universal screening for depression in perinatal populations.

While we have always been particularly interested in populations of patients at highest risk for PPD, helping women at risk for PPD in the general population without a history of psychiatric illness is a large public health issue and will be an even larger undertaking. As women’s mental health is gaining more appropriate focus, both at the local level and even in the recent White House Initiative on Women’s Health Research, the focus has been on screening and developing new treatments.

We are not lacking in pharmacologic agents nor nonpharmacologic options as treatments for women experiencing PPD. Newer alternative treatments are being explored, such as transcranial magnetic stimulation (TMS) and even psychedelics as a potential therapy for PPD. But perhaps what we’ve learned in 2023 and as we move into a new year, is that the problem of tackling PPD is not only about having the right tools, but is about helping women navigate to the care that they need.

The COVID-19 pandemic brought with it an explosion of telehealth options that have enhanced the odds women can find support during such a challenging time; as society has returned to some semblance of normal, nearly all support groups for postpartum women have remained online.

When we set up Virtual Rounds at the Center for Women’s Mental Health at the beginning of the pandemic, I was struck by the community of colleagues at various stages of their careers dedicated to mitigating the suffering associated with perinatal psychiatric illness. As I’ve often said, it takes a village to care for these patients. We need help from colleagues with varying expertise — from lactation consultants, psychiatrists, psychologists, obstetricians, nurse practitioners, support group leaders, and a host of others — who can help reach these women.

At the end of the day, helping depressed women find resources is a challenge that we have not met in this country. We should be excited that we have so many treatment options to offer patients — whether it be a new first-in-class medication, TMS, or digital apps to ensure patients are receiving effective treatment. But there should also be a focus on reaching women who still need treatment, particularly in underserved communities where resources are sparse or nonexistent. Identifying the path to reaching these women where they are and getting them well should be a top priority in 2024.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. STEPS for PPD is funded by the Marriott Foundation. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

The past year has been a challenging time for many, both at the local level and globally, with divisive undercurrents across many communities. Many times, the end of the year is an opportunity for reflection. As I reflect on the state of perinatal psychiatry in the new year, I see several evolving issues that I’d like to share in this first column of 2024.

In 2023, the American College of Obstetricians and Gynecologists published new recommendations meant to enhance the well-being of pregnant and postpartum women and families. A main message from discussion papers borne out of these recommendations was that as a field, we should be doing more than identifying perinatal illness. We should be screening women at risk for postpartum psychiatric illness and see that those suffering from posttraumatic stress disorder (PTSD) have access to care and “wrap-around services” from clinicians with varying expertise.

Screening is a primary way we identify patients at risk for psychiatric illness and also those who are suffering at the time of a screen. One problem I see in the near future is our disparate collection and management of data. When we look closely across health care systems, it’s not clear how screening data are captured, let alone managed. What is being done in one hospital system may be very different from what is being done elsewhere. Some clinicians are adopting digital platforms to identify those with postpartum depression, while others are practicing as they always have, either through a paper screening process or with queries as part of a clinical encounter.

Given this amalgam of methods for collecting and storing information, there does not appear to be a systematic way clinicians and researchers are recording whether women are meeting criteria for significant depressive symptoms or frank postpartum psychiatric illness. It is clear a more cohesive method for collection and management is needed to optimize the likelihood that next steps can be taken to get patients the care they need.

However, screening is only one part of the story. Certainly, in our own center, one of our greatest interests, both clinically and on the research side, is what happens after screening. Through our center’s initiation of the Screening and Treatment Enhancement for Postpartum Depression (STEPS for PPD) project funded by the Marriott Foundation, we are evaluating the outcomes of women who are screened at 6 weeks postpartum with significant depressive symptoms, and who are then given an opportunity to engage with a perinatal social worker who can assist with direct psychotherapy, arranging for referrals, and navigating care for a new mother.

What we are learning as we enroll women through the initial stages of STEPS for PPD is that screening and identifying women who likely suffer from PPD simply is not enough. In fact, once identified with a depression screening tool, women who are suffering from postpartum depression can be very challenging to engage clinically. What I am learning decades after starting to work with perinatal patients is that even with a screening system and effective tools for treatment of PPD, optimizing engagement with these depressed women seems a critical and understudied step on the road to optimizing positive clinical outcomes.

A recent study published in the Journal of Women’s Health explored gaps in care for perinatal depression and found that patients without a history of psychiatric illness prior to pregnancy were less likely to be screened for depression and 80% less likely to receive care if they developed depression compared with women with a previous history of psychiatric illness (J Womens Health (Larchmt). 2023 Oct;32[10]:1111-9).

That history may help women navigate to care, while women for whom psychiatric illness is a new experience may be less likely to engage, be referred for care, and receive appropriate treatment. The study indicates that, as a field, we must strive to ensure universal screening for depression in perinatal populations.

While we have always been particularly interested in populations of patients at highest risk for PPD, helping women at risk for PPD in the general population without a history of psychiatric illness is a large public health issue and will be an even larger undertaking. As women’s mental health is gaining more appropriate focus, both at the local level and even in the recent White House Initiative on Women’s Health Research, the focus has been on screening and developing new treatments.

We are not lacking in pharmacologic agents nor nonpharmacologic options as treatments for women experiencing PPD. Newer alternative treatments are being explored, such as transcranial magnetic stimulation (TMS) and even psychedelics as a potential therapy for PPD. But perhaps what we’ve learned in 2023 and as we move into a new year, is that the problem of tackling PPD is not only about having the right tools, but is about helping women navigate to the care that they need.

The COVID-19 pandemic brought with it an explosion of telehealth options that have enhanced the odds women can find support during such a challenging time; as society has returned to some semblance of normal, nearly all support groups for postpartum women have remained online.

When we set up Virtual Rounds at the Center for Women’s Mental Health at the beginning of the pandemic, I was struck by the community of colleagues at various stages of their careers dedicated to mitigating the suffering associated with perinatal psychiatric illness. As I’ve often said, it takes a village to care for these patients. We need help from colleagues with varying expertise — from lactation consultants, psychiatrists, psychologists, obstetricians, nurse practitioners, support group leaders, and a host of others — who can help reach these women.

At the end of the day, helping depressed women find resources is a challenge that we have not met in this country. We should be excited that we have so many treatment options to offer patients — whether it be a new first-in-class medication, TMS, or digital apps to ensure patients are receiving effective treatment. But there should also be a focus on reaching women who still need treatment, particularly in underserved communities where resources are sparse or nonexistent. Identifying the path to reaching these women where they are and getting them well should be a top priority in 2024.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. STEPS for PPD is funded by the Marriott Foundation. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

How can we improve the detection, assessment, and treatment of female sexual dysfunction?

Charlotte Methorst, MD, a urologist from Paris, and Carol Burté, MD, a sexologist and andrologist from Nice, dealt with these themes during a session at the French Urology Association’s 2023 conference, emphasizing the need for doctors to be involved in female sexual health.

“There’s currently a real disconnect; doctors talk very little about sexual health, yet it’s a topic that patients would really like to talk about. And this is even truer for women,” said Dr. Methorst.

“We need to spot sexual dysfunction because the topic is rarely broached spontaneously by female patients (19%) and even less so by healthcare workers (9%). Nowadays, it’s a very common problem (40%). Sexual dysfunction affects quality of life and a couple’s relationship. It also can reveal other conditions,” added Dr. Burté.
 

Spot and Assess

In terms of detecting the condition, the reference tool is the self-assessed Female Sexual Function Index, which comprises 19 questions covering six areas of sexual dysfunction: Desire, subjective arousal, lubrication, orgasm, satisfaction, and pain or discomfort.

But it is also possible to use the Sexual Complaints Screener for Women that evaluates sexual health over the past 6 months, explains Dr. Burté. For example, the patient is asked if she has had a lack of or low interest in sex or sexual desire in the past 6 months and if this has been a problem. She is also asked if she has experienced any pain during or after sexual activity.

To understand the root cause of sexual dysfunction, clinicians need to investigate the patient’s sexual health and perform a medical assessment. It’s also essential to ask the patient about her previous sexual, medical, and psychological history and to evaluate the couple and contributory factors, such as stress, fatigue, etc. This approach is known as the biopsychosocial model.

Once the contributory factors have been determined, relevant information can be given to the patient about her specific sexual problem, and the most suitable therapeutic approaches can be discussed with her.
 

Which Treatment Pathway?

Some problems may be improved with simple advice and lifestyle changes, but sex therapy and medication are options in other cases, explained the two doctors. “Since the causes of sexual dysfunction in women are mostly multifactorial, an integrative approach is needed,” said Dr. Burté.

The two main types of therapy that might be proposed for sexual dysfunction are sex therapies with cognitive behavioral therapy (CBT) and certain medicines being used as first-line treatment.

Using CBT in sexology requires patients and therapists to look past prejudices, preconceived ideas, and dysfunctional patterns and learn new behavioral, cognitive, and attentional strategies in terms of sexual health, regardless of whether an individual or couple is being treated.
 

Which Medicines?

Vasoactive drugs such as phosphodiesterase 5 inhibitors and prostaglandin have produced disappointing results. Drugs that act on the central nervous system to stimulate sexual desire, such as bremelanotide and flibanserin, don’t have marketing authorization in France due to their “insufficient” risk-benefit ratio.

However, topical hormone treatments (such as estrogen and dehydroepiandrosterone) are often used, particularly for cases of recurrent cystitis, in postmenopausal women and to treat urinary incontinence. “These topical treatments are very effective and can really change the life of a woman who no longer has a sex life because she is in discomfort and simply has dryness of the vulva and vagina,” said Dr. Burté, who recommends prescribing creams, which are better tolerated than pessaries.

General hormone treatments, hormone replacement therapy (HRT), and tibolone are prescribed to postmenopausal women.

Another option not yet authorized in France is testosterone because sexual desire depends on this hormone. An international consensus (2019, 10 learned societies) and recommendations made by the International Society for the Study of Women’s Sexual Health advise treatment with testosterone in the postmenopausal period, with or without HRT. The dose prescribed is a 10th of the male dose administered subcutaneously (300 µ/d) once a woman›s blood testosterone level has been determined to make sure there is an actual deficiency and to restore her testosterone to near premenopausal levels.

Both doctors indicated that having the chance to work with other doctors as part of a network is essential, especially with a sexual health specialist, if necessary.

Dr. Burté reported no conflicts of interest regarding the content of this article. Dr. Methorst reported relationships with several pharmaceutical laboratories.

This article was translated from the Medscape French edition.

How can we improve the detection, assessment, and treatment of female sexual dysfunction?

Charlotte Methorst, MD, a urologist from Paris, and Carol Burté, MD, a sexologist and andrologist from Nice, dealt with these themes during a session at the French Urology Association’s 2023 conference, emphasizing the need for doctors to be involved in female sexual health.

“There’s currently a real disconnect; doctors talk very little about sexual health, yet it’s a topic that patients would really like to talk about. And this is even truer for women,” said Dr. Methorst.

“We need to spot sexual dysfunction because the topic is rarely broached spontaneously by female patients (19%) and even less so by healthcare workers (9%). Nowadays, it’s a very common problem (40%). Sexual dysfunction affects quality of life and a couple’s relationship. It also can reveal other conditions,” added Dr. Burté.
 

Spot and Assess

In terms of detecting the condition, the reference tool is the self-assessed Female Sexual Function Index, which comprises 19 questions covering six areas of sexual dysfunction: Desire, subjective arousal, lubrication, orgasm, satisfaction, and pain or discomfort.

But it is also possible to use the Sexual Complaints Screener for Women that evaluates sexual health over the past 6 months, explains Dr. Burté. For example, the patient is asked if she has had a lack of or low interest in sex or sexual desire in the past 6 months and if this has been a problem. She is also asked if she has experienced any pain during or after sexual activity.

To understand the root cause of sexual dysfunction, clinicians need to investigate the patient’s sexual health and perform a medical assessment. It’s also essential to ask the patient about her previous sexual, medical, and psychological history and to evaluate the couple and contributory factors, such as stress, fatigue, etc. This approach is known as the biopsychosocial model.

Once the contributory factors have been determined, relevant information can be given to the patient about her specific sexual problem, and the most suitable therapeutic approaches can be discussed with her.
 

Which Treatment Pathway?

Some problems may be improved with simple advice and lifestyle changes, but sex therapy and medication are options in other cases, explained the two doctors. “Since the causes of sexual dysfunction in women are mostly multifactorial, an integrative approach is needed,” said Dr. Burté.

The two main types of therapy that might be proposed for sexual dysfunction are sex therapies with cognitive behavioral therapy (CBT) and certain medicines being used as first-line treatment.

Using CBT in sexology requires patients and therapists to look past prejudices, preconceived ideas, and dysfunctional patterns and learn new behavioral, cognitive, and attentional strategies in terms of sexual health, regardless of whether an individual or couple is being treated.
 

Which Medicines?

Vasoactive drugs such as phosphodiesterase 5 inhibitors and prostaglandin have produced disappointing results. Drugs that act on the central nervous system to stimulate sexual desire, such as bremelanotide and flibanserin, don’t have marketing authorization in France due to their “insufficient” risk-benefit ratio.

However, topical hormone treatments (such as estrogen and dehydroepiandrosterone) are often used, particularly for cases of recurrent cystitis, in postmenopausal women and to treat urinary incontinence. “These topical treatments are very effective and can really change the life of a woman who no longer has a sex life because she is in discomfort and simply has dryness of the vulva and vagina,” said Dr. Burté, who recommends prescribing creams, which are better tolerated than pessaries.

General hormone treatments, hormone replacement therapy (HRT), and tibolone are prescribed to postmenopausal women.

Another option not yet authorized in France is testosterone because sexual desire depends on this hormone. An international consensus (2019, 10 learned societies) and recommendations made by the International Society for the Study of Women’s Sexual Health advise treatment with testosterone in the postmenopausal period, with or without HRT. The dose prescribed is a 10th of the male dose administered subcutaneously (300 µ/d) once a woman›s blood testosterone level has been determined to make sure there is an actual deficiency and to restore her testosterone to near premenopausal levels.

Both doctors indicated that having the chance to work with other doctors as part of a network is essential, especially with a sexual health specialist, if necessary.

Dr. Burté reported no conflicts of interest regarding the content of this article. Dr. Methorst reported relationships with several pharmaceutical laboratories.

This article was translated from the Medscape French edition.

How can we improve the detection, assessment, and treatment of female sexual dysfunction?

Charlotte Methorst, MD, a urologist from Paris, and Carol Burté, MD, a sexologist and andrologist from Nice, dealt with these themes during a session at the French Urology Association’s 2023 conference, emphasizing the need for doctors to be involved in female sexual health.

“There’s currently a real disconnect; doctors talk very little about sexual health, yet it’s a topic that patients would really like to talk about. And this is even truer for women,” said Dr. Methorst.

“We need to spot sexual dysfunction because the topic is rarely broached spontaneously by female patients (19%) and even less so by healthcare workers (9%). Nowadays, it’s a very common problem (40%). Sexual dysfunction affects quality of life and a couple’s relationship. It also can reveal other conditions,” added Dr. Burté.
 

Spot and Assess

In terms of detecting the condition, the reference tool is the self-assessed Female Sexual Function Index, which comprises 19 questions covering six areas of sexual dysfunction: Desire, subjective arousal, lubrication, orgasm, satisfaction, and pain or discomfort.

But it is also possible to use the Sexual Complaints Screener for Women that evaluates sexual health over the past 6 months, explains Dr. Burté. For example, the patient is asked if she has had a lack of or low interest in sex or sexual desire in the past 6 months and if this has been a problem. She is also asked if she has experienced any pain during or after sexual activity.

To understand the root cause of sexual dysfunction, clinicians need to investigate the patient’s sexual health and perform a medical assessment. It’s also essential to ask the patient about her previous sexual, medical, and psychological history and to evaluate the couple and contributory factors, such as stress, fatigue, etc. This approach is known as the biopsychosocial model.

Once the contributory factors have been determined, relevant information can be given to the patient about her specific sexual problem, and the most suitable therapeutic approaches can be discussed with her.
 

Which Treatment Pathway?

Some problems may be improved with simple advice and lifestyle changes, but sex therapy and medication are options in other cases, explained the two doctors. “Since the causes of sexual dysfunction in women are mostly multifactorial, an integrative approach is needed,” said Dr. Burté.

The two main types of therapy that might be proposed for sexual dysfunction are sex therapies with cognitive behavioral therapy (CBT) and certain medicines being used as first-line treatment.

Using CBT in sexology requires patients and therapists to look past prejudices, preconceived ideas, and dysfunctional patterns and learn new behavioral, cognitive, and attentional strategies in terms of sexual health, regardless of whether an individual or couple is being treated.
 

Which Medicines?

Vasoactive drugs such as phosphodiesterase 5 inhibitors and prostaglandin have produced disappointing results. Drugs that act on the central nervous system to stimulate sexual desire, such as bremelanotide and flibanserin, don’t have marketing authorization in France due to their “insufficient” risk-benefit ratio.

However, topical hormone treatments (such as estrogen and dehydroepiandrosterone) are often used, particularly for cases of recurrent cystitis, in postmenopausal women and to treat urinary incontinence. “These topical treatments are very effective and can really change the life of a woman who no longer has a sex life because she is in discomfort and simply has dryness of the vulva and vagina,” said Dr. Burté, who recommends prescribing creams, which are better tolerated than pessaries.

General hormone treatments, hormone replacement therapy (HRT), and tibolone are prescribed to postmenopausal women.

Another option not yet authorized in France is testosterone because sexual desire depends on this hormone. An international consensus (2019, 10 learned societies) and recommendations made by the International Society for the Study of Women’s Sexual Health advise treatment with testosterone in the postmenopausal period, with or without HRT. The dose prescribed is a 10th of the male dose administered subcutaneously (300 µ/d) once a woman›s blood testosterone level has been determined to make sure there is an actual deficiency and to restore her testosterone to near premenopausal levels.

Both doctors indicated that having the chance to work with other doctors as part of a network is essential, especially with a sexual health specialist, if necessary.

Dr. Burté reported no conflicts of interest regarding the content of this article. Dr. Methorst reported relationships with several pharmaceutical laboratories.

This article was translated from the Medscape French edition.

TOPLINE:

Pregnancy weight gain is lower in women with a history of gastric bypass or sleeve gastrectomy than in those without such a history, especially when the interval between surgery and conception is shorter, new data suggest.

METHODOLOGY:

• Using Swedish national registers, researchers investigated the association of pregnancy weight gain with  history in 12,776 pregnancies — 6388 in women with a history of bariatric surgery and 6388 in women without such a history.
• Pregnancies were propensity score matched to patients’ early-pregnancy body mass index (BMI), prepregnancy diabetes, , smoking status, education, height, country of birth, and delivery year.
• Post-gastric bypass pregnancies were matched to post-sleeve gastrectomy pregnancies using the same matching strategy.
• Time from surgery to conception was also assessed.

TAKEAWAY:

• Across all early-pregnancy BMI strata, women with a history of bariatric surgery had lower pregnancy weight gain than matched controls.
• The magnitude of difference was largest for women with normal weight or overweight early-pregnancy BMI status (adjusted mean difference in z score, −0.33), which then decreased stepwise within the  subclasses (−0.21, −0.16, and −0.08 for obesity classes I, II, and III, respectively).
• Pregnancy weight gain did not differ by surgery type, but lower pregnancy weight gain was associated with a shorter surgery-to-conception interval (particularly within 1 year) or lower surgery-to-conception weight loss.

IN PRACTICE:

“The highest proportion of weight gain below the recommendations was found among women with a normal weight status. Hence, clinical attention to women with history of bariatric surgery and a normal weight status in early pregnancy might be warranted,” the authors advised.

SOURCE:

The study, with the first author Huiling Xu, MD, MSc, Karolinska Institutet, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Despite rigorous matching, residual confounding was possible. The sample size was limited for some subgroups, possibly affecting statistical power. Although the study provides an overview of pregnancy outcomes within surgery-to-conception interval and pregnancy weight gain z scores, a more in-depth investigation is needed to understand the associations among bariatric surgery, pregnancy weight gain, and pregnancy outcomes.

DISCLOSURES:

Research for this study was supported by the Swedish Research Council for Health, Working Life and Welfare, and the Swedish Research Council. The authors have no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Pregnancy weight gain is lower in women with a history of gastric bypass or sleeve gastrectomy than in those without such a history, especially when the interval between surgery and conception is shorter, new data suggest.

METHODOLOGY:

• Using Swedish national registers, researchers investigated the association of pregnancy weight gain with  history in 12,776 pregnancies — 6388 in women with a history of bariatric surgery and 6388 in women without such a history.
• Pregnancies were propensity score matched to patients’ early-pregnancy body mass index (BMI), prepregnancy diabetes, , smoking status, education, height, country of birth, and delivery year.
• Post-gastric bypass pregnancies were matched to post-sleeve gastrectomy pregnancies using the same matching strategy.
• Time from surgery to conception was also assessed.

TAKEAWAY:

• Across all early-pregnancy BMI strata, women with a history of bariatric surgery had lower pregnancy weight gain than matched controls.
• The magnitude of difference was largest for women with normal weight or overweight early-pregnancy BMI status (adjusted mean difference in z score, −0.33), which then decreased stepwise within the  subclasses (−0.21, −0.16, and −0.08 for obesity classes I, II, and III, respectively).
• Pregnancy weight gain did not differ by surgery type, but lower pregnancy weight gain was associated with a shorter surgery-to-conception interval (particularly within 1 year) or lower surgery-to-conception weight loss.

IN PRACTICE:

“The highest proportion of weight gain below the recommendations was found among women with a normal weight status. Hence, clinical attention to women with history of bariatric surgery and a normal weight status in early pregnancy might be warranted,” the authors advised.

SOURCE:

The study, with the first author Huiling Xu, MD, MSc, Karolinska Institutet, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Despite rigorous matching, residual confounding was possible. The sample size was limited for some subgroups, possibly affecting statistical power. Although the study provides an overview of pregnancy outcomes within surgery-to-conception interval and pregnancy weight gain z scores, a more in-depth investigation is needed to understand the associations among bariatric surgery, pregnancy weight gain, and pregnancy outcomes.

DISCLOSURES:

Research for this study was supported by the Swedish Research Council for Health, Working Life and Welfare, and the Swedish Research Council. The authors have no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Pregnancy weight gain is lower in women with a history of gastric bypass or sleeve gastrectomy than in those without such a history, especially when the interval between surgery and conception is shorter, new data suggest.

METHODOLOGY:

• Using Swedish national registers, researchers investigated the association of pregnancy weight gain with  history in 12,776 pregnancies — 6388 in women with a history of bariatric surgery and 6388 in women without such a history.
• Pregnancies were propensity score matched to patients’ early-pregnancy body mass index (BMI), prepregnancy diabetes, , smoking status, education, height, country of birth, and delivery year.
• Post-gastric bypass pregnancies were matched to post-sleeve gastrectomy pregnancies using the same matching strategy.
• Time from surgery to conception was also assessed.

TAKEAWAY:

• Across all early-pregnancy BMI strata, women with a history of bariatric surgery had lower pregnancy weight gain than matched controls.
• The magnitude of difference was largest for women with normal weight or overweight early-pregnancy BMI status (adjusted mean difference in z score, −0.33), which then decreased stepwise within the  subclasses (−0.21, −0.16, and −0.08 for obesity classes I, II, and III, respectively).
• Pregnancy weight gain did not differ by surgery type, but lower pregnancy weight gain was associated with a shorter surgery-to-conception interval (particularly within 1 year) or lower surgery-to-conception weight loss.

IN PRACTICE:

“The highest proportion of weight gain below the recommendations was found among women with a normal weight status. Hence, clinical attention to women with history of bariatric surgery and a normal weight status in early pregnancy might be warranted,” the authors advised.

SOURCE:

The study, with the first author Huiling Xu, MD, MSc, Karolinska Institutet, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

Despite rigorous matching, residual confounding was possible. The sample size was limited for some subgroups, possibly affecting statistical power. Although the study provides an overview of pregnancy outcomes within surgery-to-conception interval and pregnancy weight gain z scores, a more in-depth investigation is needed to understand the associations among bariatric surgery, pregnancy weight gain, and pregnancy outcomes.

DISCLOSURES:

Research for this study was supported by the Swedish Research Council for Health, Working Life and Welfare, and the Swedish Research Council. The authors have no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE

Babies born to mothers living in disadvantaged neighborhoods have a higher risk of being diagnosed with autism spectrum disorder (ASD), but only if they are White, a population-based prospective cohort study shows. 

METHODOLOGY

• Investigators analyzed data from a large cohort of singleton children with insurance born in Kaiser Permanente Southern California hospitals between 2001 and 2014.
• They ascertained ASD diagnosis, maternal race and ethnicity, and maternal address at time of birth.
• Neighborhood disadvantage was determined by the percentage of families in the mother’s neighborhood considered to be living in poverty, unemployed, have female-headed households with children, using public assistance, less than a high school education, among other variables.

TAKEAWAY

• Among 318,300 mothers who delivered babies during the study period, 6350 children were diagnosed with ASD during follow-up, and median age at diagnosis was 3.5 years.
• Greater neighborhood disadvantage at birth was associated with a higher likelihood of ASD diagnosis (adjusted hazard ratio [aHR], 1.07; 95% CI, 1.02-1.11)
• ASD diagnoses were more likely among children of mothers who were Black (aHR, 1.13; 95% CI, 1.02-1.25), Asian/Pacific Islander (aHR, 1.11; 95% CI, 1.02-1.20), or Hispanic (aHR, 1.07; 95% CI, 1.00-1.15), even after the researchers controlled for neighborhood.
• While odds of an ASD diagnosis were higher among children from minority racial and ethnic groups, neighborhood disadvantage was significantly associated with ASD diagnosis only for children of White mothers (aHR, 1.17; 95% CI, 1.09-1.26).

IN PRACTICE

Investigators noted that they could only speculate about the factors driving the association between neighborhood disadvantage and a stronger risk for ASD diagnosis in children of White mothers. “They may be due to systemic racism, discrimination, and their impact on maternal health during pregnancy,” they wrote.

SOURCE

Xin Yu, MS, and Daniel Hackman, PhD, of the University of Southern California Los Angeles, led the study, which was published online November 15 in JAMA Psychiatry. 

LIMITATIONS

The research was limited by a lack of information on fathers and variables such as incomes, which may have confounded the findings. The authors also acknowledged that the study should be replicated in other health service settings. 

DISCLOSURES

The study was funded by the National Institutes on Environmental Health Sciences, the National Institutes of Health (NIH), and the Environmental Protection Agency. Dr. Hackman reported receiving grant funding from NIH during the conduct of the study. Other disclosures are available in the original study. 
 

A version of this article appeared on Medscape.com.

TOPLINE

Babies born to mothers living in disadvantaged neighborhoods have a higher risk of being diagnosed with autism spectrum disorder (ASD), but only if they are White, a population-based prospective cohort study shows. 

METHODOLOGY

• Investigators analyzed data from a large cohort of singleton children with insurance born in Kaiser Permanente Southern California hospitals between 2001 and 2014.
• They ascertained ASD diagnosis, maternal race and ethnicity, and maternal address at time of birth.
• Neighborhood disadvantage was determined by the percentage of families in the mother’s neighborhood considered to be living in poverty, unemployed, have female-headed households with children, using public assistance, less than a high school education, among other variables.

TAKEAWAY

• Among 318,300 mothers who delivered babies during the study period, 6350 children were diagnosed with ASD during follow-up, and median age at diagnosis was 3.5 years.
• Greater neighborhood disadvantage at birth was associated with a higher likelihood of ASD diagnosis (adjusted hazard ratio [aHR], 1.07; 95% CI, 1.02-1.11)
• ASD diagnoses were more likely among children of mothers who were Black (aHR, 1.13; 95% CI, 1.02-1.25), Asian/Pacific Islander (aHR, 1.11; 95% CI, 1.02-1.20), or Hispanic (aHR, 1.07; 95% CI, 1.00-1.15), even after the researchers controlled for neighborhood.
• While odds of an ASD diagnosis were higher among children from minority racial and ethnic groups, neighborhood disadvantage was significantly associated with ASD diagnosis only for children of White mothers (aHR, 1.17; 95% CI, 1.09-1.26).

IN PRACTICE

Investigators noted that they could only speculate about the factors driving the association between neighborhood disadvantage and a stronger risk for ASD diagnosis in children of White mothers. “They may be due to systemic racism, discrimination, and their impact on maternal health during pregnancy,” they wrote.

SOURCE

Xin Yu, MS, and Daniel Hackman, PhD, of the University of Southern California Los Angeles, led the study, which was published online November 15 in JAMA Psychiatry. 

LIMITATIONS

The research was limited by a lack of information on fathers and variables such as incomes, which may have confounded the findings. The authors also acknowledged that the study should be replicated in other health service settings. 

DISCLOSURES

The study was funded by the National Institutes on Environmental Health Sciences, the National Institutes of Health (NIH), and the Environmental Protection Agency. Dr. Hackman reported receiving grant funding from NIH during the conduct of the study. Other disclosures are available in the original study. 
 

A version of this article appeared on Medscape.com.

TOPLINE

Babies born to mothers living in disadvantaged neighborhoods have a higher risk of being diagnosed with autism spectrum disorder (ASD), but only if they are White, a population-based prospective cohort study shows. 

METHODOLOGY

• Investigators analyzed data from a large cohort of singleton children with insurance born in Kaiser Permanente Southern California hospitals between 2001 and 2014.
• They ascertained ASD diagnosis, maternal race and ethnicity, and maternal address at time of birth.
• Neighborhood disadvantage was determined by the percentage of families in the mother’s neighborhood considered to be living in poverty, unemployed, have female-headed households with children, using public assistance, less than a high school education, among other variables.

TAKEAWAY

• Among 318,300 mothers who delivered babies during the study period, 6350 children were diagnosed with ASD during follow-up, and median age at diagnosis was 3.5 years.
• Greater neighborhood disadvantage at birth was associated with a higher likelihood of ASD diagnosis (adjusted hazard ratio [aHR], 1.07; 95% CI, 1.02-1.11)
• ASD diagnoses were more likely among children of mothers who were Black (aHR, 1.13; 95% CI, 1.02-1.25), Asian/Pacific Islander (aHR, 1.11; 95% CI, 1.02-1.20), or Hispanic (aHR, 1.07; 95% CI, 1.00-1.15), even after the researchers controlled for neighborhood.
• While odds of an ASD diagnosis were higher among children from minority racial and ethnic groups, neighborhood disadvantage was significantly associated with ASD diagnosis only for children of White mothers (aHR, 1.17; 95% CI, 1.09-1.26).

IN PRACTICE

Investigators noted that they could only speculate about the factors driving the association between neighborhood disadvantage and a stronger risk for ASD diagnosis in children of White mothers. “They may be due to systemic racism, discrimination, and their impact on maternal health during pregnancy,” they wrote.

SOURCE

Xin Yu, MS, and Daniel Hackman, PhD, of the University of Southern California Los Angeles, led the study, which was published online November 15 in JAMA Psychiatry. 

LIMITATIONS

The research was limited by a lack of information on fathers and variables such as incomes, which may have confounded the findings. The authors also acknowledged that the study should be replicated in other health service settings. 

DISCLOSURES

The study was funded by the National Institutes on Environmental Health Sciences, the National Institutes of Health (NIH), and the Environmental Protection Agency. Dr. Hackman reported receiving grant funding from NIH during the conduct of the study. Other disclosures are available in the original study. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

Among adolescent pregnancies in the United States, the prevalence of e-cigarette use during the third trimester increased from 0.8% in 2016 to 4.1% in 2021, according to research published online on December 13 in JAMA Network Open. 

METHODOLOGY:

• Researchers analyzed data from the 2016-2021 Pregnancy Risk Assessment Monitoring System.
• They focused on 10,428 adolescents aged 10-19 years who had had a singleton birth and provided information about their use of e-cigarettes or cigarettes.

TAKEAWAY:

• Whereas the researchers found a roughly fivefold increase in the exclusive use of e-cigarettes, the percentage of patients using only cigarettes decreased from 9.2% in 2017 to 3.2% in 2021.
• The percentage of patients who both vaped and smoked fluctuated between 0.6% and 1.6%.
• The rate of small-for-gestational-age (SGA) births for adolescents who did not smoke or vape (12.9%) did not differ significantly from that among adolescents who exclusively used e-cigarettes (16.8%) or those who used both cigarettes and e-cigarettes (17.6%).
• The researchers found use of cigarettes only was associated with a significantly higher rate of SGA births: 24.6%.

IN PRACTICE:

“Exclusive e-cigarette use and dual use of cigarettes and e-cigarettes did not seem to be statistically significantly associated with SGA birth in our analysis, but this finding should be interpreted with caution given the low prevalence of use and the limited sample size,” the study authors wrote.

SOURCE:

Xiaozhong Wen, MD, PhD, with the Jacobs School of Medicine and Biomedical Sciences at the State University of New York at Buffalo, was the corresponding author of the study. 

LIMITATIONS:

Participants may have underreported their use of e-cigarettes and cigarettes because of fears of social stigma. The researchers lacked information about vaping in the first and second trimesters, exposure to secondhand smoke, cannabis use, and diet. 

DISCLOSURES:

The research was supported by the National Institute on Drug Abuse; the Food and Drug Administration Center for Tobacco Products; the National Heart, Lung, and Blood Institute; and the American Heart Association. A study coauthor has received grants from Pfizer and personal fees from Johnson & Johnson, the World Health Organization, and the Campaign for Tobacco-Free Kids.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Among adolescent pregnancies in the United States, the prevalence of e-cigarette use during the third trimester increased from 0.8% in 2016 to 4.1% in 2021, according to research published online on December 13 in JAMA Network Open. 

METHODOLOGY:

• Researchers analyzed data from the 2016-2021 Pregnancy Risk Assessment Monitoring System.
• They focused on 10,428 adolescents aged 10-19 years who had had a singleton birth and provided information about their use of e-cigarettes or cigarettes.

TAKEAWAY:

• Whereas the researchers found a roughly fivefold increase in the exclusive use of e-cigarettes, the percentage of patients using only cigarettes decreased from 9.2% in 2017 to 3.2% in 2021.
• The percentage of patients who both vaped and smoked fluctuated between 0.6% and 1.6%.
• The rate of small-for-gestational-age (SGA) births for adolescents who did not smoke or vape (12.9%) did not differ significantly from that among adolescents who exclusively used e-cigarettes (16.8%) or those who used both cigarettes and e-cigarettes (17.6%).
• The researchers found use of cigarettes only was associated with a significantly higher rate of SGA births: 24.6%.

IN PRACTICE:

“Exclusive e-cigarette use and dual use of cigarettes and e-cigarettes did not seem to be statistically significantly associated with SGA birth in our analysis, but this finding should be interpreted with caution given the low prevalence of use and the limited sample size,” the study authors wrote.

SOURCE:

Xiaozhong Wen, MD, PhD, with the Jacobs School of Medicine and Biomedical Sciences at the State University of New York at Buffalo, was the corresponding author of the study. 

LIMITATIONS:

Participants may have underreported their use of e-cigarettes and cigarettes because of fears of social stigma. The researchers lacked information about vaping in the first and second trimesters, exposure to secondhand smoke, cannabis use, and diet. 

DISCLOSURES:

The research was supported by the National Institute on Drug Abuse; the Food and Drug Administration Center for Tobacco Products; the National Heart, Lung, and Blood Institute; and the American Heart Association. A study coauthor has received grants from Pfizer and personal fees from Johnson & Johnson, the World Health Organization, and the Campaign for Tobacco-Free Kids.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Among adolescent pregnancies in the United States, the prevalence of e-cigarette use during the third trimester increased from 0.8% in 2016 to 4.1% in 2021, according to research published online on December 13 in JAMA Network Open. 

METHODOLOGY:

• Researchers analyzed data from the 2016-2021 Pregnancy Risk Assessment Monitoring System.
• They focused on 10,428 adolescents aged 10-19 years who had had a singleton birth and provided information about their use of e-cigarettes or cigarettes.

TAKEAWAY:

• Whereas the researchers found a roughly fivefold increase in the exclusive use of e-cigarettes, the percentage of patients using only cigarettes decreased from 9.2% in 2017 to 3.2% in 2021.
• The percentage of patients who both vaped and smoked fluctuated between 0.6% and 1.6%.
• The rate of small-for-gestational-age (SGA) births for adolescents who did not smoke or vape (12.9%) did not differ significantly from that among adolescents who exclusively used e-cigarettes (16.8%) or those who used both cigarettes and e-cigarettes (17.6%).
• The researchers found use of cigarettes only was associated with a significantly higher rate of SGA births: 24.6%.

IN PRACTICE:

“Exclusive e-cigarette use and dual use of cigarettes and e-cigarettes did not seem to be statistically significantly associated with SGA birth in our analysis, but this finding should be interpreted with caution given the low prevalence of use and the limited sample size,” the study authors wrote.

SOURCE:

Xiaozhong Wen, MD, PhD, with the Jacobs School of Medicine and Biomedical Sciences at the State University of New York at Buffalo, was the corresponding author of the study. 

LIMITATIONS:

Participants may have underreported their use of e-cigarettes and cigarettes because of fears of social stigma. The researchers lacked information about vaping in the first and second trimesters, exposure to secondhand smoke, cannabis use, and diet. 

DISCLOSURES:

The research was supported by the National Institute on Drug Abuse; the Food and Drug Administration Center for Tobacco Products; the National Heart, Lung, and Blood Institute; and the American Heart Association. A study coauthor has received grants from Pfizer and personal fees from Johnson & Johnson, the World Health Organization, and the Campaign for Tobacco-Free Kids.
 

A version of this article appeared on Medscape.com.

For the last 30 years, the Center for Women’s Mental Health at Massachusetts General Hospital (MGH) has had as part of its mission, the conveying of accurate information about the reproductive safety of psychiatric medications. There has been a spectrum of medicines developed across psychiatric indications over the last several decades, and many studies over those decades have attempted to delineate the reproductive safety of these agents.

With the development of new antidepressants and second-generation antipsychotics has come an appreciation of the utility of these agents across a wide range of psychiatric disease states and psychiatric symptoms. More and more data demonstrate the efficacy of these medicines for mood and anxiety disorders; these agents are also used for a broad array of symptoms from insomnia, irritability, and symptoms of posttraumatic stress disorder (PTSD) just as examples — even absent formal approval by the US Food and Drug Administration (FDA) for these specific indications. With the growing use of medicines, including new antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors, and second-generation atypical antipsychotics, there has been a greater interest and appreciation of the need to provide women with the best information about reproductive safety of these medicines as well.

When I began working in reproductive psychiatry, the FDA was using the pregnancy labeling categories introduced in 1979. The categories were simple, but also oversimplified in terms of incompletely conveying information about reproductive safety. For instance, category labels of B and C under the old labeling system could be nebulous, containing sparse information (in the case of category B) or animal data and some conflicting human data (in the case of category C) that may not have translated into relevant or easily interpretable safety information for patients and clinicians.

It was on that basis the current Pregnancy and Lactation Labeling (PLLR) Final Rule was published in 2014, which was a shift from categorical labeling to more descriptive labeling, including updated actual information on the package insert about available reproductive safety data, animal data, and data on lactation.

Even following the publication of the PLLR, there has still been an acknowledgment in the field that our assessment tools for postmarketing reproductive safety surveillance are incomplete. A recent 2-day FDA workshop hosted by the Duke-Margolis Center for Health Policy on optimizing the use of postapproval pregnancy safety studies sought to discuss the many questions that still surround this issue. Based on presentations at this workshop, a framework emerged for the future of assessing the reproductive safety of medications, which included an effort to develop the most effective model using tools such as pregnancy registries and harnessing “big data,” whether through electronic health records or large administrative databases from public and private insurers. Together, these various sources of information can provide signals of potential concern, prompting the need for a more rigorous look at the reproductive safety of a medication, or provide reassurance if data fail to indicate the absence of a signal of risk.

FDA’s new commitments under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII) include pregnancy-specific postmarketing safety requirements as well as the creation of a framework for how data from pregnancy-specific postmarketing studies can be used. The agency is also conducting demonstration projects, including one for assessing the performance of pregnancy registries for the potential to detect safety signals for medications early in pregnancy. FDA is expanding its Sentinel Initiative to help accomplish these aims, and is implementing an Active Risk Identification and Analysis (ARIA) system to conduct active safety surveillance of medications used during pregnancy.

Pregnancy registries have now been available for decades, and some have been more successful than others across different classes of medicines, with the most rigorous registries including prospective follow-up of women across pregnancies and careful documentation of malformations (at best with original source data and with a blinded dysmorphologist). Still, with all of its rigor, even the best-intentioned efforts with respect to pregnancy registries have limitations. As I mentioned in my testimony during the public comment portion of the workshop, the sheer volume of pregnancy data from administrative databases we now have access to is attractive, but the quality of these data needs to be good enough to ascertain a signal of risk if they are to be used as a basis for reproductive safety determination.

The flip side of using data from large administrative databases is using carefully collected data from pregnancy registries. With a pregnancy registry, accrual of a substantial number of participants can also take a considerable period of time, and initial risk estimates of outcomes can have typically large confidence intervals, which can make it difficult to discern whether a drug is safe for women of reproductive age.

Another key issue is a lack of participation from manufacturers with respect to commitment to collection of high-quality reproductive safety data. History has shown that many medication manufacturers, unless required to have a dedicated registry as part of a postmarketing requirement or commitment, will invest sparse resources to track data on safety of fetal drug exposure. Participation is typically voluntary and varies from company to company unless, as noted previously, there is a postmarketing requirement or commitment tied to the approval of a medication. Just as a recent concrete example, the manufacturer of a new medication recently approved by the FDA for the treatment of postpartum depression (which will include presumably sexually active women well into the first postpartum year) has no plan to support the collection of reproductive safety data on this new medication because it is not required to, based on current FDA guidelines and the absence of a postmarketing requirement to do so.
 

Looking ahead

While the PLLR was a huge step forward in the field from the old pregnancy category system that could misinform women contemplating pregnancy, it also sets the stage for the next iteration of a system that allows us to generate information more quickly about the reproductive safety of medications. In psychiatry, as many as 10% of women use SSRIs during pregnancy. With drugs like atypical antipsychotics being used across disease states — in schizophrenia, bipolar disorder, depression, anxiety, insomnia, and PTSD — and where new classes of medicine are becoming available, like with ketamine or steroids, we need to have a system by which we can more quickly ascertain reproductive safety information. This information informs treatment decisions during a critical life event of deciding to try to become pregnant or during an actual pregnancy.

In my mind, it is reassuring when a registry has even as few as 50-60 cases of fetal exposure without an increase in the risk for malformation, because it can mean we are not seeing a repeat of the past with medications like thalidomide and sodium valproate. However, patients and clinicians are starved for better data. Risk assessment is also different from clinician to clinician and patient to patient. We want to empower patients to make decisions that work for them based on more rapidly accumulating information and help inform their decisions.

To come out on the “other side” of the PLLR, we will need to find a way to accelerate our ability to identify signals of risk or information that is reassuring (or not reassuring) so that clinicians and patients are not left waiting for the next paper to come out, which can be confusing when study results frequently conflict. I believe we have an obligation today to do this better, because the areas of reproductive toxicology and pharmacovigilance are growing incredibly quickly, and clinicians and patients are seeing these volumes of data being published without the ability to integrate that information in a systematic way.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

For the last 30 years, the Center for Women’s Mental Health at Massachusetts General Hospital (MGH) has had as part of its mission, the conveying of accurate information about the reproductive safety of psychiatric medications. There has been a spectrum of medicines developed across psychiatric indications over the last several decades, and many studies over those decades have attempted to delineate the reproductive safety of these agents.

With the development of new antidepressants and second-generation antipsychotics has come an appreciation of the utility of these agents across a wide range of psychiatric disease states and psychiatric symptoms. More and more data demonstrate the efficacy of these medicines for mood and anxiety disorders; these agents are also used for a broad array of symptoms from insomnia, irritability, and symptoms of posttraumatic stress disorder (PTSD) just as examples — even absent formal approval by the US Food and Drug Administration (FDA) for these specific indications. With the growing use of medicines, including new antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors, and second-generation atypical antipsychotics, there has been a greater interest and appreciation of the need to provide women with the best information about reproductive safety of these medicines as well.

When I began working in reproductive psychiatry, the FDA was using the pregnancy labeling categories introduced in 1979. The categories were simple, but also oversimplified in terms of incompletely conveying information about reproductive safety. For instance, category labels of B and C under the old labeling system could be nebulous, containing sparse information (in the case of category B) or animal data and some conflicting human data (in the case of category C) that may not have translated into relevant or easily interpretable safety information for patients and clinicians.

It was on that basis the current Pregnancy and Lactation Labeling (PLLR) Final Rule was published in 2014, which was a shift from categorical labeling to more descriptive labeling, including updated actual information on the package insert about available reproductive safety data, animal data, and data on lactation.

Even following the publication of the PLLR, there has still been an acknowledgment in the field that our assessment tools for postmarketing reproductive safety surveillance are incomplete. A recent 2-day FDA workshop hosted by the Duke-Margolis Center for Health Policy on optimizing the use of postapproval pregnancy safety studies sought to discuss the many questions that still surround this issue. Based on presentations at this workshop, a framework emerged for the future of assessing the reproductive safety of medications, which included an effort to develop the most effective model using tools such as pregnancy registries and harnessing “big data,” whether through electronic health records or large administrative databases from public and private insurers. Together, these various sources of information can provide signals of potential concern, prompting the need for a more rigorous look at the reproductive safety of a medication, or provide reassurance if data fail to indicate the absence of a signal of risk.

FDA’s new commitments under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII) include pregnancy-specific postmarketing safety requirements as well as the creation of a framework for how data from pregnancy-specific postmarketing studies can be used. The agency is also conducting demonstration projects, including one for assessing the performance of pregnancy registries for the potential to detect safety signals for medications early in pregnancy. FDA is expanding its Sentinel Initiative to help accomplish these aims, and is implementing an Active Risk Identification and Analysis (ARIA) system to conduct active safety surveillance of medications used during pregnancy.

Pregnancy registries have now been available for decades, and some have been more successful than others across different classes of medicines, with the most rigorous registries including prospective follow-up of women across pregnancies and careful documentation of malformations (at best with original source data and with a blinded dysmorphologist). Still, with all of its rigor, even the best-intentioned efforts with respect to pregnancy registries have limitations. As I mentioned in my testimony during the public comment portion of the workshop, the sheer volume of pregnancy data from administrative databases we now have access to is attractive, but the quality of these data needs to be good enough to ascertain a signal of risk if they are to be used as a basis for reproductive safety determination.

The flip side of using data from large administrative databases is using carefully collected data from pregnancy registries. With a pregnancy registry, accrual of a substantial number of participants can also take a considerable period of time, and initial risk estimates of outcomes can have typically large confidence intervals, which can make it difficult to discern whether a drug is safe for women of reproductive age.

Another key issue is a lack of participation from manufacturers with respect to commitment to collection of high-quality reproductive safety data. History has shown that many medication manufacturers, unless required to have a dedicated registry as part of a postmarketing requirement or commitment, will invest sparse resources to track data on safety of fetal drug exposure. Participation is typically voluntary and varies from company to company unless, as noted previously, there is a postmarketing requirement or commitment tied to the approval of a medication. Just as a recent concrete example, the manufacturer of a new medication recently approved by the FDA for the treatment of postpartum depression (which will include presumably sexually active women well into the first postpartum year) has no plan to support the collection of reproductive safety data on this new medication because it is not required to, based on current FDA guidelines and the absence of a postmarketing requirement to do so.
 

Looking ahead

While the PLLR was a huge step forward in the field from the old pregnancy category system that could misinform women contemplating pregnancy, it also sets the stage for the next iteration of a system that allows us to generate information more quickly about the reproductive safety of medications. In psychiatry, as many as 10% of women use SSRIs during pregnancy. With drugs like atypical antipsychotics being used across disease states — in schizophrenia, bipolar disorder, depression, anxiety, insomnia, and PTSD — and where new classes of medicine are becoming available, like with ketamine or steroids, we need to have a system by which we can more quickly ascertain reproductive safety information. This information informs treatment decisions during a critical life event of deciding to try to become pregnant or during an actual pregnancy.

In my mind, it is reassuring when a registry has even as few as 50-60 cases of fetal exposure without an increase in the risk for malformation, because it can mean we are not seeing a repeat of the past with medications like thalidomide and sodium valproate. However, patients and clinicians are starved for better data. Risk assessment is also different from clinician to clinician and patient to patient. We want to empower patients to make decisions that work for them based on more rapidly accumulating information and help inform their decisions.

To come out on the “other side” of the PLLR, we will need to find a way to accelerate our ability to identify signals of risk or information that is reassuring (or not reassuring) so that clinicians and patients are not left waiting for the next paper to come out, which can be confusing when study results frequently conflict. I believe we have an obligation today to do this better, because the areas of reproductive toxicology and pharmacovigilance are growing incredibly quickly, and clinicians and patients are seeing these volumes of data being published without the ability to integrate that information in a systematic way.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

For the last 30 years, the Center for Women’s Mental Health at Massachusetts General Hospital (MGH) has had as part of its mission, the conveying of accurate information about the reproductive safety of psychiatric medications. There has been a spectrum of medicines developed across psychiatric indications over the last several decades, and many studies over those decades have attempted to delineate the reproductive safety of these agents.

With the development of new antidepressants and second-generation antipsychotics has come an appreciation of the utility of these agents across a wide range of psychiatric disease states and psychiatric symptoms. More and more data demonstrate the efficacy of these medicines for mood and anxiety disorders; these agents are also used for a broad array of symptoms from insomnia, irritability, and symptoms of posttraumatic stress disorder (PTSD) just as examples — even absent formal approval by the US Food and Drug Administration (FDA) for these specific indications. With the growing use of medicines, including new antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors, and second-generation atypical antipsychotics, there has been a greater interest and appreciation of the need to provide women with the best information about reproductive safety of these medicines as well.

When I began working in reproductive psychiatry, the FDA was using the pregnancy labeling categories introduced in 1979. The categories were simple, but also oversimplified in terms of incompletely conveying information about reproductive safety. For instance, category labels of B and C under the old labeling system could be nebulous, containing sparse information (in the case of category B) or animal data and some conflicting human data (in the case of category C) that may not have translated into relevant or easily interpretable safety information for patients and clinicians.

It was on that basis the current Pregnancy and Lactation Labeling (PLLR) Final Rule was published in 2014, which was a shift from categorical labeling to more descriptive labeling, including updated actual information on the package insert about available reproductive safety data, animal data, and data on lactation.

Even following the publication of the PLLR, there has still been an acknowledgment in the field that our assessment tools for postmarketing reproductive safety surveillance are incomplete. A recent 2-day FDA workshop hosted by the Duke-Margolis Center for Health Policy on optimizing the use of postapproval pregnancy safety studies sought to discuss the many questions that still surround this issue. Based on presentations at this workshop, a framework emerged for the future of assessing the reproductive safety of medications, which included an effort to develop the most effective model using tools such as pregnancy registries and harnessing “big data,” whether through electronic health records or large administrative databases from public and private insurers. Together, these various sources of information can provide signals of potential concern, prompting the need for a more rigorous look at the reproductive safety of a medication, or provide reassurance if data fail to indicate the absence of a signal of risk.

FDA’s new commitments under the latest reauthorization of the Prescription Drug User Fee Act (PDUFA VII) include pregnancy-specific postmarketing safety requirements as well as the creation of a framework for how data from pregnancy-specific postmarketing studies can be used. The agency is also conducting demonstration projects, including one for assessing the performance of pregnancy registries for the potential to detect safety signals for medications early in pregnancy. FDA is expanding its Sentinel Initiative to help accomplish these aims, and is implementing an Active Risk Identification and Analysis (ARIA) system to conduct active safety surveillance of medications used during pregnancy.

Pregnancy registries have now been available for decades, and some have been more successful than others across different classes of medicines, with the most rigorous registries including prospective follow-up of women across pregnancies and careful documentation of malformations (at best with original source data and with a blinded dysmorphologist). Still, with all of its rigor, even the best-intentioned efforts with respect to pregnancy registries have limitations. As I mentioned in my testimony during the public comment portion of the workshop, the sheer volume of pregnancy data from administrative databases we now have access to is attractive, but the quality of these data needs to be good enough to ascertain a signal of risk if they are to be used as a basis for reproductive safety determination.

The flip side of using data from large administrative databases is using carefully collected data from pregnancy registries. With a pregnancy registry, accrual of a substantial number of participants can also take a considerable period of time, and initial risk estimates of outcomes can have typically large confidence intervals, which can make it difficult to discern whether a drug is safe for women of reproductive age.

Another key issue is a lack of participation from manufacturers with respect to commitment to collection of high-quality reproductive safety data. History has shown that many medication manufacturers, unless required to have a dedicated registry as part of a postmarketing requirement or commitment, will invest sparse resources to track data on safety of fetal drug exposure. Participation is typically voluntary and varies from company to company unless, as noted previously, there is a postmarketing requirement or commitment tied to the approval of a medication. Just as a recent concrete example, the manufacturer of a new medication recently approved by the FDA for the treatment of postpartum depression (which will include presumably sexually active women well into the first postpartum year) has no plan to support the collection of reproductive safety data on this new medication because it is not required to, based on current FDA guidelines and the absence of a postmarketing requirement to do so.
 

Looking ahead

While the PLLR was a huge step forward in the field from the old pregnancy category system that could misinform women contemplating pregnancy, it also sets the stage for the next iteration of a system that allows us to generate information more quickly about the reproductive safety of medications. In psychiatry, as many as 10% of women use SSRIs during pregnancy. With drugs like atypical antipsychotics being used across disease states — in schizophrenia, bipolar disorder, depression, anxiety, insomnia, and PTSD — and where new classes of medicine are becoming available, like with ketamine or steroids, we need to have a system by which we can more quickly ascertain reproductive safety information. This information informs treatment decisions during a critical life event of deciding to try to become pregnant or during an actual pregnancy.

In my mind, it is reassuring when a registry has even as few as 50-60 cases of fetal exposure without an increase in the risk for malformation, because it can mean we are not seeing a repeat of the past with medications like thalidomide and sodium valproate. However, patients and clinicians are starved for better data. Risk assessment is also different from clinician to clinician and patient to patient. We want to empower patients to make decisions that work for them based on more rapidly accumulating information and help inform their decisions.

To come out on the “other side” of the PLLR, we will need to find a way to accelerate our ability to identify signals of risk or information that is reassuring (or not reassuring) so that clinicians and patients are not left waiting for the next paper to come out, which can be confusing when study results frequently conflict. I believe we have an obligation today to do this better, because the areas of reproductive toxicology and pharmacovigilance are growing incredibly quickly, and clinicians and patients are seeing these volumes of data being published without the ability to integrate that information in a systematic way.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].

More than one in three women worldwide (at least 40 million women) annually experience lasting health problems in the months or years following childbirth, according to a new study published in The Lancet Global Health.

Those problems include pain during sexual intercourse (35%), low back pain (32%), urinary incontinence (8% to 31%), anxiety (9% to 24%), anal incontinence (19%), depression (11% to 17%), fear of childbirth (6% to 15%), perineal pain (11%), and secondary infertility (11%).

Other problems included pelvic organ prolapse, posttraumatic stress disorder, thyroid dysfunction, mastitis, HIV seroconversion (when the body begins to produce detectable levels of HIV antibodies), nerve injury, and psychosis. 

The study says most women see a doctor 6  to 12 weeks after birth and then rarely talk to doctors about these nagging health problems. Many of the problems don’t show up until 6 or more weeks after birth.

“To comprehensively address these conditions, broader and more comprehensive health service opportunities are needed, which should extend beyond 6 weeks postpartum and embrace multidisciplinary models of care,” the study says. “This approach can ensure that these conditions are promptly identified and given the attention that they deserve.”

The study is part of a series organized by the United Nation’s Special Program on Human Reproduction, the World Health Organization, and the U.S. Agency for International Development. The authors said most of the data came from high-income nations. There was little data from low-income and middle-income countries except for postpartum depression, anxiety, and psychosis.

“Many postpartum conditions cause considerable suffering in women’s daily life long after birth, both emotionally and physically, and yet they are largely underappreciated, underrecognized, and underreported,” Pascale Allotey, MD, director of Sexual and Reproductive Health and Research at WHO, said in a statement.

“Throughout their lives, and beyond motherhood, women need access to a range of services from health-care providers who listen to their concerns and meet their needs — so they not only survive childbirth but can enjoy good health and quality of life.”
 

A version of this article appeared on WebMD.com.

More than one in three women worldwide (at least 40 million women) annually experience lasting health problems in the months or years following childbirth, according to a new study published in The Lancet Global Health.

Those problems include pain during sexual intercourse (35%), low back pain (32%), urinary incontinence (8% to 31%), anxiety (9% to 24%), anal incontinence (19%), depression (11% to 17%), fear of childbirth (6% to 15%), perineal pain (11%), and secondary infertility (11%).

Other problems included pelvic organ prolapse, posttraumatic stress disorder, thyroid dysfunction, mastitis, HIV seroconversion (when the body begins to produce detectable levels of HIV antibodies), nerve injury, and psychosis. 

The study says most women see a doctor 6  to 12 weeks after birth and then rarely talk to doctors about these nagging health problems. Many of the problems don’t show up until 6 or more weeks after birth.

“To comprehensively address these conditions, broader and more comprehensive health service opportunities are needed, which should extend beyond 6 weeks postpartum and embrace multidisciplinary models of care,” the study says. “This approach can ensure that these conditions are promptly identified and given the attention that they deserve.”

The study is part of a series organized by the United Nation’s Special Program on Human Reproduction, the World Health Organization, and the U.S. Agency for International Development. The authors said most of the data came from high-income nations. There was little data from low-income and middle-income countries except for postpartum depression, anxiety, and psychosis.

“Many postpartum conditions cause considerable suffering in women’s daily life long after birth, both emotionally and physically, and yet they are largely underappreciated, underrecognized, and underreported,” Pascale Allotey, MD, director of Sexual and Reproductive Health and Research at WHO, said in a statement.

“Throughout their lives, and beyond motherhood, women need access to a range of services from health-care providers who listen to their concerns and meet their needs — so they not only survive childbirth but can enjoy good health and quality of life.”
 

A version of this article appeared on WebMD.com.

More than one in three women worldwide (at least 40 million women) annually experience lasting health problems in the months or years following childbirth, according to a new study published in The Lancet Global Health.

Those problems include pain during sexual intercourse (35%), low back pain (32%), urinary incontinence (8% to 31%), anxiety (9% to 24%), anal incontinence (19%), depression (11% to 17%), fear of childbirth (6% to 15%), perineal pain (11%), and secondary infertility (11%).

Other problems included pelvic organ prolapse, posttraumatic stress disorder, thyroid dysfunction, mastitis, HIV seroconversion (when the body begins to produce detectable levels of HIV antibodies), nerve injury, and psychosis. 

The study says most women see a doctor 6  to 12 weeks after birth and then rarely talk to doctors about these nagging health problems. Many of the problems don’t show up until 6 or more weeks after birth.

“To comprehensively address these conditions, broader and more comprehensive health service opportunities are needed, which should extend beyond 6 weeks postpartum and embrace multidisciplinary models of care,” the study says. “This approach can ensure that these conditions are promptly identified and given the attention that they deserve.”

The study is part of a series organized by the United Nation’s Special Program on Human Reproduction, the World Health Organization, and the U.S. Agency for International Development. The authors said most of the data came from high-income nations. There was little data from low-income and middle-income countries except for postpartum depression, anxiety, and psychosis.

“Many postpartum conditions cause considerable suffering in women’s daily life long after birth, both emotionally and physically, and yet they are largely underappreciated, underrecognized, and underreported,” Pascale Allotey, MD, director of Sexual and Reproductive Health and Research at WHO, said in a statement.

“Throughout their lives, and beyond motherhood, women need access to a range of services from health-care providers who listen to their concerns and meet their needs — so they not only survive childbirth but can enjoy good health and quality of life.”
 

A version of this article appeared on WebMD.com.