Journal of Women's Health

The U.S. Food and Drug Administration (FDA) has made efforts to encourage adequate assessment of women, racial/ethnic minorities, and geriatric participants in clinical trials through regulations and guidance documents. This study surveyed the demographics of clinical trial participants and the presence of efficacy and safety analyses by sex for new drugs approved between 2013 and 2015 by the FDA Center for Drug Evaluation and Research.

New drug marketing applications submitted to FDA were surveyed for demographic data (sex, race, ethnicity, and age) and the presence of sex-based analyses for efficacy and safety. The Ratio of the Proportion of women in clinical trials for the indicated disease population relative to the estimated Proportion of women in the disease population (PPR) was calculated for new drug indications.

Of the 102 new drugs in this cohort (defined as new molecular entity drugs and original therapeutic biologics), sex was reported for >99.9% of trial participants, and women accounted for 40.4% of these participants. An estimated 77.2% of participants were White, 6.4% were Black/African American, and 29.1% were aged ≥65 years. Sex-based analyses for both efficacy and safety were conducted for 93.1% of applications. PPR was calculated for 82 new drugs for a total of 60 indications, of which 50 indications (83.3%) had a PPR ≥0.80.

Sex data are now collected for almost all study participants, and this study shows appropriate sex participation for most new drugs when estimated disease prevalence by sex (PPR) is considered. Therapeutic area and disease indication are important considerations when assessing the sex of participants because variation occurs depending on the disease under study. Some racial minorities, especially Blacks/African Americans, are still not well represented in most drug development programs and remain an area where improvement is needed.

In response to an expressed need for more focused measurement of preconception health (PCH), we identify a condensed set of PCH indicators for state and national surveillance.

We used a systematic process to evaluate, prioritize, and select 10 PCH indicators that maternal and child health programs can use for surveillance. For each indicator, we assessed prevalence, whether it was addressed by professional recommendations, Healthy People 2020 objectives, or Centers for Disease Control and Prevention winnable battles, measurement simplicity, data completeness, and stakeholders' input.

Fifty PCH indicators were evaluated and prioritized. The condensed set includes indicators that rely on data from the Pregnancy Risk Assessment Monitoring System (n = 4) and the Behavioral Risk Factor Surveillance System (n = 6). The content encompasses heavy alcohol consumption, depression, diabetes, folic acid intake, hypertension, normal weight, recommended physical activity, current smoking, unwanted pregnancy, and use of contraception.

Having a condensed set of PCH indicators can facilitate surveillance of reproductive-aged women's health status that supports monitoring, comparisons, and benchmarking at the state and national levels.

Exposure to intimate partner violence (IPV) in the perinatal period is associated with obstetric complications, poor maternal mental health, neonatal complications, and increased risk of infant mortality and morbidity. Less is known about how IPV may influence small for gestational age (SGA) birth.

Data were obtained for 231,081 United States mothers who delivered neonates from 2004 to 2011 and completed the Pregnancy Risk Assessment Monitoring System survey 2–9 months after delivery. Weighted descriptive statistics and multivariate logistic regression models were used.

IPV in the year before or during pregnancy was related to SGA bivariately (odds ratio 1.39, 95% confidence interval [CI] 1.28, 1.51), and after adjustment for demographic and obstetric factors, this association attenuated after further adjustment for perinatal smoking patterns, (adjusted odds ratio [aOR] 1.06, 95% CI 0.97, 1.15). Compared with nonabused women, women experiencing perinatal IPV were more than twice as likely to smoke before pregnancy (aOR 2.34, 95% CI 2.19, 2.49), and nearly 1.5 times as likely to report sustained smoking into the last 3 months of pregnancy (aOR 1.45, 95% CI 1.32, 1.59). In turn, among prepregnancy smokers, sustained smoking was associated with delivery of a SGA neonate (aOR 1.87, 95% CI 1.72, 2.03), fully attenuating the association of perinatal IPV with SGA.

Women who experienced perinatal IPV were significantly more likely to smoke prepregnancy and sustain smoking into the last 3 months of pregnancy. Through behavioral and physiological pathways, smoking cessation may be uniquely challenging for women experiencing IPV, yet critical to address clinically to mitigate risk for SGA.

The value of exercise electrocardiogram (ExECG) in symptomatic female patients with low to intermediate risk for significant coronary artery disease (CAD) has been under debate for many years, and nondiagnostic or even erroneous test results are frequently encountered. Cardiac-CT may be more appropriate to exclude CAD in women. This study compares the results of ExECGs with those of cardiac-CTs, performed within a time frame of 1 month in an all-comers female chest pain population.

Five hundred fifty-one consecutive female patients from a patient registry were included. ExECGs were negative in 324 (59%), positive in 14 (3%), and nondiagnostic in 213 (39%) patients. CAD was revealed by cardiac-CT in 57% of the women with negative ExECG. No signs of CAD were present on cardiac-CT in 64% of the women with a positive ExECG. Cardiac-CT showed presence of CAD in 268/551 (49%) patients, of whom 56/268 (21%) was diagnosed with ≥50% stenosis. The ExECG of the latter group was negative in 26 (46%), inconclusive in 29 (52%), and positive in 1 (2%). Considering ≥50% stenosis at cardiac-CT as the reference, sensitivity, specificity, PPV, and NPV of ExECG for the present population were 3.7%, 95.7%, 7.1%, and 91.7%, respectively. Similar diagnostic performance was calculated when considering ≥70% stenosis at cardiac-CT as the reference.

ExECG failed to detect CAD in more than half of this cohort and in almost half of women with >50% stenosis at cardiac-CT. Importantly, no CAD was detected by cardiac-CT in 64% of women with a positive ExECG. ExECG is therefore questionable as a diagnostic strategy in women with low-to-intermediate risk of CAD, although prospective studies are warranted to determine whether replacing ExECG by cardiac-CT provides better prognoses.

Little is known of the prevalence and severity of menstrual dysfunction, climacteric symptoms, pelvic floor disorders, sexual problems, and psychological wellbeing after lung transplantation in women.

Adult female lung transplant recipients, attending the Alfred Hospital Lung Transplant Service in Melbourne, Australia participated in a women's health, cross-sectional questionnaire-based study.

The 123 of 149 potential participants were recruited between September 2014 and July 2015. Their median age was 53.5 years, and 44 were premenopausal, 3 perimenopausal, and 76 postmenopausal. Moderate–severe menstrual and premenstrual symptoms were common, and 43% of partnered premenopausal women were not using contraception. Vasomotor symptoms (VMS) were common in postmenopausal women <55 years (80.0%), and the use of menopausal hormone therapy was low (8.9%). The estimated prevalence of low sexual desire associated with distress was 24.4%. Low wellbeing was significantly and independently associated with being aged 50 ≤ 60 years, moderate–severe VMS, impaired forced expiratory volume in 1 second, and psychotropic medication use.

Our findings demonstrate that premenopausal lung transplant recipients need to be asked about bothersome menstrual symptoms, and contraceptive compliance needs regular review. Transplant recipients at midlife have substantially lower wellbeing than women of other ages and this needs attention, including assessment and management of menopausal symptoms.

A novel formulation of secnidazole is under development in the United States for the treatment of bacterial vaginosis (BV). Efficacy and safety of other formulations of secnidazole have been reported. The objective of this study is to evaluate the safety of a single-dose oral granule formulation of secnidazole in a U.S. population of women with BV.

In this open-label study, patients were enrolled based on the following criteria: off-white, thin, homogeneous vaginal discharge; vaginal pH ≥4.7; presence of ≥20% clue cells; and positive potassium hydroxide whiff test. Eligible patients received a single dose of secnidazole 2 g at baseline. Patients were contacted on days 8–10 and were assessed for safety at an end-of-study visit (days 21–30). Additional endpoints included investigator assessment of the need for additional treatment and a post hoc analysis of clinical response to treatment.

Of 321 patients, 283 (88.2%) completed the study. The mean age was 32 ± 8.5 years; most patients were white (51.4%) or black/African American (46.1%). Most (79.1%) reported ≤3 episodes of BV in the past year. The overall number of treatment-emergent adverse events (TEAEs) was 95 (29.6%), of which 53 (16.5%) were treatment related. Common treatment-related TEAEs were vulvovaginal mycotic infection (5.3%), nausea (4.4%), and dysgeusia (3.1%). The proportion of patients not requiring additional BV treatment, as assessed by investigators, was 72.5%.

Single-dose secnidazole 2 g was well tolerated, with a low overall number of TEAEs, most of which were mild to moderate.

The role of provider type and level of training have not been examined in regard to impact on postpartum testing for patients with gestational diabetes mellitus (GDM).

We sought to determine rates of testing in urban GDM patients and to determine factors associated with diabetes screening compliance, focusing especially on provider type.

Class A1 or A2 GDM patients were identified by chart review. Outcomes included ordering and/or performance of postpartum testing for diabetes mellitus. Chi-squared and multivariate logistic regression analyses were performed.

Of the 118 patients identified (55% class A1), 58% were African American, 52% had medical assistance insurance, and 83% attended the postpartum visit. Diabetes testing was discussed at 68% of all postpartum visits, but was only ordered at 55% of visits. The 2-hour glucose tolerance test was ordered at 42 of the 98 (43%) of postpartum visits; however, only 16 tests were completed. Patients seeing resident physicians or midwives were more likely to be tested.

Rates of postpartum testing for GDM patients are low. Provider and patient compliance with diabetes screening recommendations are inadequate. Increased education and training of providers and patients may improve screening for diabetes among GDM patients.

To determine if reproductive specialists are screening new patients for depression or anxiety, explore possible reasons why providers are not screening, and assess physician's views about the impact of mental health disorders on fertility.

Cross-sectional exploratory study in which 86 practicing reproductive physicians filled out a 20-question survey regarding mental health screening and perception of psychological disorders on reproduction.

The majority of infertility providers believe psychological conditions negatively impact pregnancy success (75%); however, most providers are not formally screening patients for depression or anxiety (28%). Providers who did not screen for depression were more likely to be uncomfortable assessing patients for mental health disorders and to work in a private practice setting.

This study finds that most infertility specialist respondents believe that mental health conditions negatively impact reproductive outcomes; however, few of these providers are screening for psychological disorders in infertile women. Reasons why providers are not screening infertility patients for psychological disorders include lack of time and unfamiliarity with recommendations for treatment of mental health conditions. Implementing a rapid screen for anxiety and depression and providing easily assessable succinct educational updates to fertility providers on current treatment options for mental health disorders may allow affected patients to be treated sooner, and ultimately, may improve fertility outcomes.

Pelvic girdle pain (PGP) and low-back pain (LBP) are the most common musculoskeletal disorders experienced during pregnancy, yet they are not familiar to healthcare providers in some countries. The objective was to compare prevalence, severity, and impact of PGP and LBP among pregnant women in the United States, the United Kingdom, Norway, and Sweden. Women's desires for, access to, and experience of treatment were also examined.

This is a cross-sectional self-reported questionnaire study of pregnant women, recruited at maternity care units in gestational weeks 30–38. Main outcome measures were presence and impact of PGP and/or LBP.

A total of 869 pregnant women from the United States (n = 214), the United Kingdom (n = 220), Norway (n = 220), and Sweden (n = 215) were included. PGP and/or LBP were reported by 70%–86%, with lowest prevalence in Scandinavia. Severity and impact differed significantly across countries (p < 0.001), with U.K. women reporting the highest pain intensity (Numeric Rating Scale [NRS] 7/10) and highest mean total score on the Pelvic Girdle Questionnaire (PGQ) (46/100). U.S. women were significantly less afflicted, with mean PGQ total score 35/100 (p ≤ 0.001). The countries differed regarding concern about PGP and/or LBP (p < 0.001), with U.K. women being most affected (NRS 5/10). Norwegian women were most likely to receive treatment (53%) and U.S. women least likely (24%) (p < 0.001). Among women receiving treatment, 68%–87% reported a positive effect.

PGP and/or LBP during pregnancy are common in the United States, the United Kingdom, Norway, and Sweden. Severity, concern, and treatment experiences differed across countries. The majority of women who received treatment reported a positive effect.

Recent studies have shown that stroke has a differential impact in women compared to men. Women are more likely to survive strokes than men, yet they experience more severe strokes resulting in greater poststroke disability. However, few studies have characterized sex differences in functional ability after stroke. This study examined sex differences in long-term disability among stroke survivors.

This was a retrospective analysis of the 2015 National Health Interview Survey. Respondents were asked to rate their ability to perform 11 functional tasks. Univariate comparisons were completed to evaluate sex differences in performance, and multinomial logistic regression was used to determine the odds of reporting functional limitations.

Five hundred fourteen men and 641 women stroke survivors completed the survey (mean age: 66.9 years). Approximately 75% of the sample reported having hypertension, 61% high cholesterol, 33% diabetes, 24% heart disease, 21% heart attack, and 16% chronic obstructive pulmonary disease. In the predictive models, men were less likely to report “very difficult/can't do at all” in walking ¼ mile (odds ratios [OR] = 0.68, 95% CI 0.51–0.90), climbing 10 steps (OR = 0.65, 95% CI 0.49–0.85), standing 2 hours (OR = 0.66, 95% CI 0.50–0.87), stooping (OR = 0.51, 95% CI 0.39–0.68), reaching overhead (OR = 0.69, 95% CI 0.49–0.97), carrying 10 pounds (OR = 0.45, 95% CI 0.34–0.59), and pushing large objects (OR = 0.37, 95% CI 0.28–0.5) compared to women.

The functional outcomes of men stroke survivors were significantly greater than women. The specific factors that contribute to sex differences in stroke-related outcomes are not entirely clear. Future research is needed to better understand these differences to ensure that equity of care is received.

Previous studies have shown that women have less access or longer waiting times to high-tech medicine compared with men. This study aimed to detect possible gender differences in access to the diagnostic high-tech method of polysomnography (PSG). Furthermore, the study explored gender differences in prevalence of specific sleep diseases.

Source data of n = 1000 patients, who underwent PSG at the Medical University of Innsbruck, were reviewed. Clinical data regarding time elapsed between symptom onset and PSG as well as final diagnoses were analyzed for gender differences.

Six hundred sixty-nine men and 331 women were examined with PSG. There were no gender differences in access to PSG after first presentation to the sleep laboratory. Significantly more men than women (13.3 vs. 6.9%) were referred to medical examination because of abnormal observations by their bed partner. In men we found more sleep-related breathing disorders and fragmentary myoclonus, whereas in women insomnia was more common. Sleep-related breathing disorders showed a more severe manifestation in men, however, there was no difference in treatment with continuous positive airway pressure/biphasic positive airway pressure therapy between male and female patients.

Twice as many men than women received a PSG. This is explained by the referral rates to the sleep laboratory. While there are well-established gender differences for some sleep disorders, the fact that twice as many men than women were referred to the sleep laboratory could indicate a lower awareness for sleep disorders in women.