Journal of women's health
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Journal of women's health · Mar 2021
Evaluating the National Institutes of Health's Sex as a Biological Variable Policy: Conflicting Accounts from the Front Lines of Animal Research.
Background: Since the National Institutes of Health (NIH) Revitalization Act of 1993, focus on the equitable inclusion of women in clinical research has been ongoing. NIH's 2015 sex as a biological variable (SABV) policy aims to transform research design, analysis, and reporting in the preclinical sphere by including male and female organisms in vertebrate animal research as well as human studies. However, questions remain regarding how researchers and members of research oversight committees perceive the value and need of the SABV policy. ⋯ There were also tensions in how interviewees conceptualized the challenges to and resources needed for implementing the SABV policy. For instance, while some thought implementation would require a significant increase in numbers of animals used for each study, others explicitly rejected this claim. Conclusions: We conclude by discussing the practical and social implications of our findings about the views of members of the animal research community regarding the SABV policy.
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Journal of women's health · Mar 2021
Willingness to Use Cannabis for Gynecological Conditions: A National Survey.
Objective: Expanded legal access to cannabis in the United States has led to its increased use for treating medical conditions. We assessed the use of and attitudes toward cannabis for treating gynecological conditions. Materials and Methods: We utilized Amazon.com Inc.'s Mechanic Turk platform to administer a survey to U. S. women 18 years and older about cannabis use for recreational and medicinal purposes and willingness to use cannabis to treat 17 gynecological conditions. ⋯ Women willing to use cannabis for gynecological conditions were most interested in using cannabis for treating gynecological pain (61.2% of never users vs. 90.0% of ever users; p < 0.001) compared with procedural pain (38.2% vs. 79.0%, respectively; p < 0.001) or other conditions (38.0% vs. 79.8%, respectively; p < 0.001). In multivariate analysis, willingness to use cannabis for a gynecological condition was associated only with a history of ever using cannabis and views that cannabis should be legal in some capacity and not by age, race, or education. Conclusions: The majority of women would consider using cannabis to treat gynecological conditions. Overall, respondents who had a history of cannabis use were more likely to report willingness to use cannabis for all gynecological conditions, but a large proportion of those who reported never using cannabis were also willing to use it.
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Journal of women's health · Mar 2021
Meta AnalysisBrexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making.
Background: Brexanolone (BRX) injection was approved by the United States Food and Drug Administration in 2019 for the treatment of adults with postpartum depression (PPD) based on two Phase 3 clinical trials. Materials and Methods: Data from the three trials were combined. PPD-specific 17-item Hamilton Rating Scale for Depression (HAMD-17) group-level minimal important difference (MID) and patient-level meaningful change (meaningful change threshold [MCT]) were estimated and applied to differences in BRX versus placebo (PBO) at hour 60 (primary endpoint) and day 30 (end of trial follow-up). ⋯ Conclusions: BRX provided meaningful changes relative to PBO, rapid (hour 60), and sustained improvements (day 30) in PPD symptoms, low NNT, and large NNH. These results may help inform treatment decision-making. Clinicaltrials.gov registration numbers: NCT02614547, NCT02942004, and NCT02942017.
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Journal of women's health · Mar 2021
Randomized Controlled TrialEvaluation of a Discussion Guide to Promote Patient Understanding of Menopause and Informed Treatment Decision-Making.
Background: Patient-provider communication surrounding menopause symptoms and treatment is often limited. We developed and evaluated a health literacy-appropriate discussion guide to support patient education. Materials and Methods: A cross-sectional randomized study was conducted among 100 English-speaking women, aged 45-60 years, in Chicago, IL, and Durham, NC. Participants were randomly assigned to review either the discussion guide or a standard education material (n = 50 per arm) and to complete an open book knowledge questionnaire; they then rated the appearance and quality of both materials. ⋯ M = 18.1, SD = 2.6; p < 0.001); 82.0% of those exposed to the discussion guide correctly answered ≥85% of knowledge items compared with only 48.0% of those reviewing the standard material (p < 0.001). In multivariable analyses, participants receiving the discussion guide displayed significantly greater knowledge in comparison with those receiving the standard material regardless of whether knowledge was examined as a score (∝ = 1.9, 95% confidence interval [CI]: 0.9-2.9, p < 0.001) or 85% threshold (odds ratio: 5.7, 95% CI: 2.0-16.2, p < 0.001). More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content. Conclusions: The discussion guide improved understanding of menopause symptoms and treatment options in comparison with a current standard and was well received by a diverse audience.
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Journal of women's health · Mar 2021
A Prospective Study of the Relationship of Sleep Quality and Duration with Gestational Weight Gain and Fat Gain.
Objective/Background: Fewer than one-third of U. S. women meet the Institute of Medicine guidelines for healthy gestational weight gain (GWG). While poor sleep quality and short sleep duration have been associated with weight gain and obesity in the general population, the relationship of sleep with pregnancy weight and body composition changes is unclear. ⋯ Conclusions: Lower sleep quality and shorter sleep duration in late pregnancy were associated with greater GFG. Experimental studies are needed to test the direction of causality between GFG and sleep attributes. ClinicalTrials.gov ID: NCT02217462.