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BackgroundThis study prospectively assesses the mental health outcomes among women seeking abortions, by comparing women having later abortions with women denied abortions, up to 2 years post-abortion seeking.MethodWe present the first 2 years of a 5-year telephone interview study that is following 956 women who sought an abortion from 30 facilities throughout the USA. We use adjusted linear mixed-effects regression analyses to assess whether symptoms of depression and anxiety, as measured by the Brief Symptom Inventory-short form and the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire, differ over time among women denied an abortion due to advanced gestational age, compared with women who received abortions.ResultsBaseline predicted mean depressive symptom scores for women denied abortion (3.07) were similar to women receiving an abortion just below the gestational limit (2.86). Depressive symptoms declined over time, with no difference between groups. Initial predicted mean anxiety symptoms were higher among women denied care (2.59) than among women who had an abortion just below the gestational limit (1.91). Anxiety levels in the two groups declined and converged after 1 year.ConclusionsWomen who received an abortion had similar or lower levels of depression and anxiety than women denied an abortion. Our findings do not support the notion that abortion is a cause of mental health problems.

Objective Unintended pregnancy is common and disproportionately occurs among low-income women. We conducted a qualitative study with low-income women to better typologize pregnancy intention, understand the relationship between pregnancy intention and contraceptive use, and identify the contextual factors that shape pregnancy intention and contraceptive behavior. Study design Semistructured interviews were conducted with low-income, African-American and white women aged 18-45 recruited from reproductive health clinics in Pittsburgh, PA, to explore factors that influence women's pregnancy-related behaviors. Narratives were analyzed using content analysis and the constant comparison method. Results Among the 66 participants (36 African-American and 30 white), we identified several factors that may impede our public health goal of increasing the proportion of pregnancies that are consciously desired and planned. First, women do not always perceive that they have reproductive control and therefore do not necessarily formulate clear pregnancy intentions. Second, the benefits of a planned pregnancy may not be evident. Third, because preconception intention and planning do not necessarily occur, decisions about the acceptability of a pregnancy are often determined after the pregnancy has already occurred. Finally, even when women express a desire to avoid pregnancy, their contraceptive behaviors are not necessarily congruent with their desires. We also identified several clinically relevant and potentially modifiable factors that help to explain this intention-behavior discrepancy, including women's perceptions of low fecundity and their experiences with male partner contraceptive sabotage. Conclusion Our findings suggest that the current conceptual framework that views pregnancy-related behaviors from a strict planned behavior perspective may be limited, particularly among low-income populations. Implications This study identified several cognitive and interpersonal pathways to unintended pregnancy among low-income women in Pittsburgh, PA, including perceptions of low reproductive control, perceptions of low fecundity and male partner reproductive coercion.

Abstract: Using the US National Comorbidity Survey (NCS), published an analysis indicating that compared to women who had never had an abortion, women who had reported an abortion were at an increased risk of several anxiety, mood, and substance use disorders. Here, we show that those results are not replicable. That is, using the same data, sample, and codes as indicated by those authors, it is not possible to replicate the simple bivariate statistics testing the relationship of ever having had an abortion to each mental health disorder when no factors were controlled for in analyses ( in ). Furthermore, among women with prior pregnancies in the NCS, we investigated whether having zero, one, or multiple abortions (abortion history) was associated with having a mood, anxiety, or substance use disorder at the time of the interview. In doing this, we tested two competing frameworks: the abortion-as-trauma versus the common-risk-factors approach. Our results support the latter framework. In the bivariate context when no other factors were included in models, abortion history was not related to having a mood disorder, but it was related to having an anxiety or substance use disorder. When prior mental health and violence experience were controlled in our models, no significant relation was found between abortion history and anxiety disorders. When these same risk factors and other background factors were controlled, women who had multiple abortions remained at an increased risk of having a substance use disorder compared to women who had no abortions, likely because we were unable to control for other risk factors associated with having an abortion and substance use. Policy, practice, and research should focus on assisting women at greatest risk of having unintended pregnancies and having poor mental health—those with violence in their lives and prior mental health problems. [ABSTRACT FROM AUTHOR]

Background: The proportion of abortions provided by medication in the United States and worldwide has increased greatly since the U.S. Food and Drug Administration approved mifepristone in 2000. While existing research has shown that abortion does not increase risk of mental health problems, no population-based study has examined specifically whether a procedural or medication abortion increases risk of mental health disorders., Objective: This study examined whether mental health disorders increased in the shorter and longer-term after a medication or procedural abortion., Study Design: Using Danish population registers' data, we conducted a prospective cohort study in which we included 72,424 females born in Denmark between 1980 and 2006, who were ages 12 to 38 during the study period and had a first first-trimester abortion before 13 weeks gestation in 2000 to 2018. Females with no previous psychiatric diagnoses were followed from 1 year before their abortion until their first psychiatric diagnosis, December 31, 2018, emigration from Demark, or death, whichever came first. Risk of any first psychiatric disorder was defined as a recorded psychiatric diagnosis at an in- or out-patient facility from the 1 year after to more than 5 years after a medication or procedural abortion relative to the year beforehand. Results were adjusted for calendar year, age, gestational age, partner status, prior mental and physical health, childbirth history, childhood environment, and parental mental health history., Results: Females having medication (n=37,155) and procedural abortions (n=35,269) had the same risk of any first psychiatric diagnosis in the year after their abortion relative to the year before their abortion (medication abortion adjusted incidence rate ratio [MaIRR]=1.02, 95% confidence interval [CI]: 0.93-1.12; procedural abortion adjusted incidence rate ratio [PaIRR]=0.94, 95% CI: 0.86-1.02). Moreover, as more time from the abortion passed, the risk of a psychiatric diagnoses decreased relative to the year before their abortion for each abortion method (MaIRR 1-2 years after=0.89, 95% CI: 0.80-0.98; PaIRR 1-2 years after=0.81, 95% CI: 0.88-1.05; MaIRR 2-5 years after=0.77, 95% CI: 0.71-0.84; PaIRR 2-5 years after=0.72, 95% CI: 0.67-0.78; MaIRR 5+ years after=0.58, 95% CI: 0.53-0.63; PaIRR 5+ years after=0.54, 95% CI: 0.50-0.58)., Conclusion: Because the risk of psychiatric diagnoses was the same in the year after relative to the year before a medication and procedural abortion and the risk did not increase as more time after the abortion increased, neither abortion method increased risk of mental health disorders in the shorter or longer-term., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Symptoms of mental distress increased sharply during the COVID-19 pandemic, especially among older adolescents and young adults. Mental health distress may make it more challenging for young people to seek other needed health care, including contraception. This study explored the association of symptoms of depression, anxiety, and stress with delays in getting a contraceptive method or prescription. Materials and Methods: Data from a supplementary study (May 15, 2020-March 20, 2023) to a cluster randomized trial in 29 sites in Texas and California were used. The diverse study sample included community college students assigned female at birth of ages 18-29 years ( n = 1,665 with 7,023 observations over time). We measured the association of depression (CES-D [Center for Epidemiologic Studies Depression Scale]) or anxiety and stress (DASS-21 [Depression Anxiety Stress Scales]) symptoms with delayed contraceptive care-seeking with mixed-effects multivariable regression with random effects for individual and site. We controlled for age and sociodemographic factors important for access to care. Results: Over one-third of participants (35%) reported they delayed getting the contraceptive method they needed. Multivariable regression results showed increased odds of delayed contraceptive care among participants with symptoms of depression (adjusted odds ratio [aOR] 1.58, 95% confidence interval [CI] 1.27-1.96). Likewise, delays were associated with anxiety and stress symptoms (aOR 1.46, 95% CI 1.17-1.82). Adolescents were more likely to delay seeking contraception than young adults (aOR 1.32, 95% CI 1.07-1.63). Conclusions: Results showed a strong association between mental distress and delayed contraception. Interventions are needed to increase contraceptive access for young people delaying care, along with supportive mental health care services, including for adolescents who face elevated odds of delay. ClinicalTrials.gov Identifier: NCT03519685.

This is a protocol for a systematic review and meta-analysis of research on mental health outcomes of abortion. Does abortion increase the risk of adverse mental health outcomes? That is the central question for this review. Our review aims to inform policy and practice by locating, critically appraising, and synthesizing empirical evidence on associations between abortion and subsequent mental health outcomes. Given the controversies surrounding this topic and the complex social, political, legal, and ideological contexts in which research and reviews on abortion are conducted, it is especially important to conduct this systematic review and meta-analysis with comprehensive, rigorous, unbiased, and transparent methods. We will include a variety of study designs to enhance understanding of studies' methodological strengths and weaknesses and to identify potential explanations for conflicting results. We will follow open science principles, providing access to our methods, measures, and results, and making data available for re-analysis., (© 2024 The Authors. Campbell Systematic Reviews published by John Wiley & Sons Ltd on behalf of The Campbell Collaboration.)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and have the following interests to declare: MAB, BM, and JRS have been paid as expert scientists in the area of abortion and mental health in legal cases challenging abortion policies. NLS received reimbursement for travel expenses related to pro bono expert testimony. MAB, RWB, DGF, CBP, CHR, JRS, JVD, and UDU were awarded grants to conduct research or reviews on the relationship between abortion and mental health. LBH is a named plaintiff in a case regarding abortion rights (SisterSong v State of Georgia). NLS served on the board of directors of Physicians for Reproductive Health. TMO received a speaker fee from Lundbeck Pharma A/S for a talk on prediction of postpartum depression. The views expressed here are those of the authors and do not necessarily reflect those of their employers or other organisations. Provenance and peer review: Not commissioned; externally peer reviewed.

Objective: To describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials., Methods: Gynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data., Results: 2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013-2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years - REMGs made up 19.6% of trial participants in 2007-2009 compared to 38.1% in 2016-2018 (p < 0.0001)., Conclusion: Less than half of trials that published results reported race/ethnicity data. Available data reveals that enrollment of REMGs is significantly below expected rates based on national census data. These disparities persisted even after additionally adjusting for population size. Despite improvement in recent years, additional recruitment of REMGs is needed to achieve more representative and equitable participation in gynecologic cancer clinical trials., Competing Interests: Declaration of Competing Interest Dario Roque reported grant funding from Robert A. Winn Diversity in Clinical Trials Award Program and from Robert A. Winn Diversity in Clinical Trials Award Program Sponsorship by Bristol Myers Squibb Foundation and pay to the institution, as well as personal fees from Myriad and GlaxoSmithKlein. John Chan reported personal fees from Agenus, AstraZeneca, Eisai, Genmab, GlaxoSmithKline, Immounogen, Merck, Mersana, Molecular Targeting Technologies, Myriad, Roche, and Seagen outside the submitted work. Ritu Salani reported royalties from UpToDate, leadership roles at the International Gynecologic Cancer Society Executive Committe, and personal fees from Eisai, Immunogen, Merck, Mersana, Regeron, and Seagen. All author authors reported no conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Inclusive clinical trials are necessary to improve maternal health equity. We aimed to analyze the current state of race and ethnicity reporting and representation in obstetric trials and the association with trial focus for all U.S.-based obstetric trials between 2007 and 2020. In this cross-sectional, multivariable regression analysis, the exposure variable was clinical trial focus (eg, prematurity), and the outcomes were race and ethnicity reporting and representation of diverse cohorts. Obstetric anesthesia trials reported race and ethnicity the least frequently of all trial foci (adjusted odds ratio 0.2, 95% CI 0.08-0.48). Hypertension and obstetric anesthesia trials enrolled the lowest proportion of Black participants, and prematurity trials enrolled the lowest proportion of Latinx and Asian participants. All researchers should strive to improve measurement and reporting of demographic data as well participation of diverse cohorts., Competing Interests: Financial Disclosure Dario R. Roque has served on the Speaker's Bureau for GSK and performed consulting for Myriad and Intuitive Surgical (surgical proctor). Dr. Roque's institution received grant funding through the Robert A. Winn Diversity in Clinical Trials Award, funded by the Bristol-Myers Squibb Foundation. The other authors did not report any potential conflicts of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Female underrepresentation in oncology clinical trials can result in outcome disparities. We evaluated female participant representation in US oncology trials by intervention type, cancer site, and funding., Materials and Methods: Data were extracted from the publicly available Aggregate Analysis of ClinicalTrials.gov database. Initially, 270,172 studies were identified. Following the exclusion of trials using Medical Subject Heading terms, manual review, those with incomplete status, non-US location, sex-specific organ cancers, or lacking participant sex data, 1650 trials consisting of 240,776 participants remained. The primary outcome was participation to prevalence ratio (PPR): percent females among trial participants divided by percent females in the disease population per US Surveillance, Epidemiology, and End Results Program data. PPRs of 0.8-1.2 reflect proportional female representation., Results: Females represented 46.9% of participants (95% CI, 45.4-48.4); mean PPR for all trials was 0.912. Females were underrepresented in surgical (PPR 0.74) and other invasive (PPR 0.69) oncology trials. Among cancer sites, females were underrepresented in bladder (odds ratio [OR] 0.48, 95% CI 0.26-0.91, P = .02), head/neck (OR 0.44, 95% CI 0.29-0.68, P < .01), stomach (OR 0.40, 95% CI 0.23-0.70, P < .01), and esophageal (OR 0.40 95% CI 0.22-0.74, P < .01) trials. Hematologic (OR 1.78, 95% CI 1.09-1.82, P < .01) and pancreatic (OR 2.18, 95% CI 1.46-3.26, P < .01) trials had higher odds of proportional female representation. Industry-funded trials had greater odds of proportional female representation (OR 1.41, 95% CI 1.09-1.82, P = .01) than US government and academic-funded trials., Conclusions: Stakeholders should look to hematologic, pancreatic, and industry-funded cancer trials as exemplars of female participant representation and consider female representation when interpreting trial results., (© The Author(s) 2023. Published by Oxford University Press.)

Background: Clinical trials form the backbone of evidence-based medicine. ClinicalTrials.gov is the world's largest clinical trial registry, and the state of clinical trials in plastic and reconstructive surgery (PRS) within that database has not been comprehensively studied. To that end, we explored the distribution of therapeutic areas that are under investigation, impact of funding on study design and data reporting, and trends in research patterns of all PRS interventional clinical trials registered with ClinicalTrials.gov., Methods: Using the ClinicalTrials.gov database, we identified and extracted all clinical trials relevant to PRS that were submitted between 2007 and 2020. Studies were classified based on anatomic locations, therapeutic categories, and specialty topics. Cox proportional hazard was used to calculate adjusted hazard ratios (HRs) for early discontinuation and results reporting., Results: A total of 3224 trials that included 372,095 participants were identified. The PRS trials grew at an annual rate of 7.9%. The therapeutic classes most represented were wound healing (41.3%) and cosmetics (18.1%). Funding for PRS clinical trials is largely provided through academic institutions (72.7%), while industry and US government constituted a minority. Industry-funded studies were more likely to be discontinued early than those funded by academics (HR, 1.89) or government (HR, 1.92) and to be nonblinded and nonrandomized. Academic-funded studies were the least likely to report results data within 3 years of trial completion (odds ratio, 0.87)., Conclusions: A gulf exists in the representation of different PRS specialties among clinical trials. We highlight the role of funding source in trial design and data reporting to identify a potential source of financial waste and to stress the need for continued appropriate oversight., Competing Interests: Conflicts of interest and sources of funding: none declared., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background and Objectives: Representative enrollment of racial and ethnic minoritized populations in biomedical research ensures the generalizability of results and equitable access to novel therapies. Previous studies on pediatric clinical trial diversity are limited to subsets of journals or disciplines. We aimed to evaluate race and ethnicity reporting and representation in all US pediatric clinical trials on ClinicalTrials.gov., Methods: We performed a cross-sectional study of US-based clinical trials registered on ClinicalTrials.gov that enrolled participants aged <18 years old between October 2007 and March 2020. We used descriptive statistics, compound annual growth rates, and multivariable logistic regression for data analysis. Estimates of US population statistics and disease burden were calculated with the US Census, Kids' Inpatient Database, and National Survey of Children's Health., Results: Among 1183 trials encompassing 405 376 participants, race and ethnicity reporting significantly increased from 27% in 2007 to 87% in 2018 (P < .001). The median proportional enrollment of Asian American children was 0.6% (interquartile range [IQR], 0%-3.7%); American Indian, 0% (IQR, 0%-0%); Black, 12% (IQR, 2.9%-28.4%); Hispanic, 7.1% (IQR, 0%-18.6%); and white 66.4% (IQR, 41.5%-81.6%). Asian American, Black, and Hispanic participants were underrepresented relative to US population demographics. Compared with expected proportions based on disease prevalence and hospitalizations, Asian American and Hispanic participants were most consistently underrepresented across diagnoses., Conclusions: While race and ethnicity reporting in pediatric clinical trials has improved, the representative enrollment of minoritized participants remains an ongoing challenge. Evidence-based and policy solutions are needed to address these disparities to advance biomedical innovation for all children., (Copyright © 2023 by the American Academy of Pediatrics.)

Rationale: Policymakers need to know the abortion attitudes of those they represent. In addition, inaccurate knowledge of or negative attitudes toward abortion may lead to more abortion stigma, which may adversely affect abortion access and women's health., Objective: The first objective was to examine whether individual's abortion knowledge and attitudes changed during 2016-2020 in Delaware and Maryland. The second was to explore whether personally knowing someone who had an abortion in 2020 was associated with knowledge, attitudes, and changes in them from 2016 to 2020., Methods: Data were from the Delaware [Maryland] Survey of Women, a probability sample that was self-administered via web and mail (N = 1106). Women aged 18-44 from Delaware and Maryland were followed from 2016/2017 to 2019/2020. Outcomes were each two facets of abortion knowledge (perceived safety and perceived access) and abortion attitudes (acceptability and advocacy self-identification), and changes in these outcomes. The main predictor was whether women personally knew someone who had an abortion. Covariates included state, religiosity, pregnancy history, and sociodemographic factors. We used logistic models with inverse probability weights., Results: The percentage of respondents who changed between the first and third waves varied: 46% changed their views on safety and accessibility; 21% changed their views on acceptability; and 25% changed their advocacy self-identification. Knowing someone personally who had an abortion was associated with changing toward viewing abortion as very safe and towards pro-choice, and with not changing towards viewing abortion as wrong or identifying as pro-life., Conclusions: These findings suggest abortion knowledge and attitudes are not fixed but change over time, and knowing someone who had an abortion or having an abortion oneself was associated with changing toward positive attitudes and accurate knowledge. Sharing one's abortion experience with others one knows may reduce negative attitudes and inaccurate knowledge regarding abortion., Competing Interests: Declaration of competing interest None reported., (Copyright © 2023. Published by Elsevier Ltd.)

Racial inequities are well-documented across the gynecologic oncology care continuum, including the representation of racial and ethnic minoritized groups (REMGs) in gynecologic oncology clinical trials. We specifically reviewed the scope of REMG disparities, contributing factors, and strategies to improve inclusion. We found systematic and progressively worsening under-enrollment of REMGs, particularly of Black and Latinx populations. In addition, race/ethnicity data reporting is poor, yet a prerequisite for accountability to recruitment goals. Trial participation barriers are multifactorial, and successful remediation likely requires multi-level strategies. More rigorous, transparent data on trial participants and effectiveness studies on REMG recruitment strategies are needed to improve enrollment., Competing Interests: D.R.R.: Speakers Bureau: GSK, Myriad; Consultant: Myriad, Intuitive. The remaining authors declare no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Importance: Clinical trials guide evidence-based obstetrics and gynecology (OB-GYN) but often enroll nonrepresentative participants., Objective: To characterize race and ethnicity reporting and representation in US OB-GYN clinical trials and their subsequent publications and to analyze the association of subspecialty and funding with diverse representation., Design and Setting: Cross-sectional analysis of all OB-GYN studies registered on ClinicalTrials.gov (2007-2020) and publications from PubMed and Google Scholar (2007-2021). Analyses included logistic regression controlling for year, subspecialty, phase, funding, and site number. Data from 332 417 studies were downloaded. Studies with a noninterventional design, with a registration date before October 1, 2007, without relevance to OB-GYN, with no reported results, and with no US-based study site were excluded., Exposures: OB-GYN subspecialty and funder., Main Outcomes and Measures: Reporting of race and ethnicity data and racial and ethnic representation (the proportion of enrollees of American Indian or Alaskan Native, Asian, Black, Latinx, or White identity and odds of representation above US Census estimates by race and ethnicity)., Results: Among trials with ClinicalTrials.gov results (1287 trials with 591 196 participants) and publications (1147 trials with 821 111 participants), 662 (50.9%) and 856 (74.6%) reported race and ethnicity data, respectively. Among publications, gynecology studies were significantly less likely to report race and ethnicity than obstetrics (adjusted odds ratio [aOR], 0.54; 95% CI, 0.38-0.75). Reproductive endocrinology and infertility trials had the lowest odds of reporting race and ethnicity (aOR, 0.14; 95% CI, 0.07-0.27; reference category, obstetrics). Obstetrics and family planning demonstrated the most diverse clinical trial cohorts. Compared with obstetric trials, gynecologic oncology had the lowest odds of Black representation (ClinicalTrials.gov: aOR, 0.04; 95% CI, 0.02-0.09; publications: aOR, 0.06; 95% CI, 0.03-0.11) and Latinx representation (ClinicalTrials.gov: aOR, 0.05; 95% CI, 0.02-0.14; publications: aOR, 0.23; 95% CI, 0.10-0.48), followed by urogynecology and reproductive endocrinology and infertility. Urogynecology (ClinicalTrials.gov: aOR, 0.15; 95% CI, 0.05-0.39; publications: aOR, 0.24; 95% CI, 0.09-0.58) had the lowest odds of Asian representation., Conclusions and Relevance: Race and ethnicity reporting and representation in OB-GYN trials are suboptimal. Obstetrics and family planning trials demonstrate improved representation is achievable. Nonetheless, all subspecialties should strive for more equitably representative research.

Rationale: Understanding whether postpartum depressive (PPD) symptoms vary by pregnancy intention and use of fertility treatments has implications for reproductive health policies and practices., Objective: The first aim of this study was to determine whether PPD symptoms differ between women who had unintended pregnancies, women who conceived spontaneously and were unsure about their pregnancy intention, women who used fertility treatments to conceive, and women who conceived spontaneously and intentionally. The second aim was to determine whether PPD symptoms differed based on the fertility treatment used to conceive (fertility drugs only, medicated insemination, or assisted reproductive technology [ART])., Methods: Data from the Pregnancy Risk Assessment Monitoring System (2012-2019), a cross-sectional survey administered to women throughout the U.S. who have recently given birth, was used to carry out our aims., Results: For the first aim (unweighted N = 243,677), compared to women who had spontaneous, intended pregnancies, women who had unintended pregnancies (OR: 1.32, 95% CI: 1.26-1.39, p < 0.01) and those with spontaneous pregnancies who were unsure about their intention (OR: 1.30, 95% CI: 1.23-1.38, p < 0.01) had higher odds of elevated PPD symptoms, adjusting for a range of covariates. Women who conceived with fertility treatments did not have higher odds of elevated PPD symptoms (OR: 0.97, 95% CI: 0.84-1.10, p = 0.61). For the second aim (unweighted N = 2,210), compared to those in the ART group, those who conceived using only fertility enhancing drugs had greater odds of developing elevated PPD symptoms (OR: 2.00, 95% CI: 1.24-3.24, p < 0.01)., Conclusions: These findings suggest that giving birth to an unintended pregnancy in the U.S. increases risk of elevated PPD symptoms. While overall women who conceive with the use of fertility treatments are not at increased risk of experiencing elevated PPD symptoms, there may be variability in risk based on the specific fertility treatments used., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Mobile health (mHealth) technology that addresses diabetes mellitus in pregnancy has the potential to improve maternal and child health while diminishing socioeconomic and racial disparities. Little is known about health literacy, electronic health literacy, or patient characteristics that contribute to increased mHealth use. In this pilot study, we aimed to examine patient factors associated with user engagement with a novel app for diabetes support during pregnancy., Method: Low-income pregnant individuals with gestational or type 2 diabetes mellitus were recruited for a 2-week usability assessment of a novel mHealth smartphone application, "SweetMama," designed to improve diabetes care. This analysis of user characteristics was a pilot assessment of data from the usability study phase. Participants completed assessments of patient health literacy, electronic health literacy, diabetes self-efficacy, and activation. User metrics (eg, sessions and total duration of use) were evaluated by participant characteristics. Descriptive analyses were conducted to assess outcomes with respect to patient's clinical history, health literacy, electronic health literacy, diabetes self-efficacy, and activation., Results: Twenty-two diverse, low-income pregnant patients with either gestational or type 2 diabetes engaged with SweetMama for 14 days. Participants with gestational diabetes had greater mean minutes of use per session and mean total duration of use than those with type 2 diabetes. Participants with greater electronic health literacy, lower patient activation, and greater self-efficacy demonstrated greater total duration of use. No user metrics differed significantly by participant general health literacy., Conclusions: Findings of this pilot study suggest engagement with a novel mHealth app for diabetes support during pregnancy varied by baseline behavioral and clinical characteristics. Results could indicate that digital health literacy better differentiates engagement patterns than general health literacy.

Background: Obstetrical clinical trials are the foundation of evidence-based medicine during pregnancy. As more obstetrical trials are conducted, understanding the publication characteristics of these trials is of utmost importance to advance obstetrical health., Objective: This study aimed to characterize the frequency of publication and trial characteristics associated with publication among obstetrical clinical trials in the United States. We additionally sought to examine time from trial completion to publication., Study Design: This was a cross-sectional analysis of completed obstetrical trials with an intervention design and at least 1 site in the United States registered to ClinicalTrials.gov from 2007 to 2019. Trial characteristics were cross-referenced with PubMed to determine publication status up to 2021 using the National Clinical Trial identification number. Bivariable analyses were conducted to determine trial characteristics associated with publication. Multivariable logistic regression models controlling for prespecified covariates were generated to estimate the relationship between funding, primary purpose, and therapeutic foci with publication. Additional exploratory analyses of other trial characteristics were conducted. Time to publication was analyzed using Kaplan-Meier curves and Cox regression models., Results: Of the 1879 obstetrical trials with registered completion, a total of 575 (30.6%) had at least 1 site in the United States, were completed before October 1, 2019, and were included in this analysis. Between October 2007 and October 2019, fewer than two-thirds (N=348, 60.5%) of trials reached publication. Annual rates of publication ranged from 46.4% in 2018 to 70.0% in 2007. No difference was observed in publication by funding, primary purpose, or therapeutic foci (all P>.05). Trials with characteristics indicating high trial quality-including randomized allocation scheme, ≥50 participants enrolled, ≥2 sites, and presence of a data safety monitoring committee-had increased odds of publication compared with those without such characteristics (all P<.05). For example, studies with randomized allocation of intervention had 2-fold greater odds of publication than nonrandomized studies (adjusted odds ratio, 2.09; 95% confidence interval, 1.30-3.37). Studies with ≥150 participants had nearly 8-fold odds of publication (adjusted odds ratio, 7.90; 95% confidence interval, 3.78-17.49) relative to studies with <50 participants. Temporal analysis demonstrated variability in time to publication among obstetrical trials, with a median time of 20.1 months after trial completion, and with most trials that reached publication having been published by 40 months. No difference was observed in time to publication by funding, primary purpose, or therapeutic foci (all P>.05)., Conclusion: Publication of obstetrical trials remains suboptimal, with significant differences observed between trials with indicators of high quality and those without. Most trials that reach publication are published within 2 years of registered completion on ClinicalTrials.gov., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: Afghanistan is one of the countries with the highest prevalence of spousal violence (56%) and a low prevalence of contraceptive use (23%), yet there is no study assessing how spousal violence is related to contraceptive use, and what methods are most used by women. Therefore, this study examined the association between the number of types of spousal violence and contraceptive use., Method: Using data from 18,985 Afghan married women, aged 15 to 49, who responded to the 2015 Afghanistan Demographic and Health Survey, the current contraceptive method was grouped into five categories: male-involved methods, pills, injectables, long-acting reversible contraception, female sterilization, and Lactation Amenorrhea Method. The number of types of spousal violence in the past 12 months was categorized as none, one type, or two or more types, based on women's experiences with verbal, physical, and sexual violence. For analysis, binary and multinomial logistic regression were used., Results: After adjusting for the covariates, the experience of any spousal violence was associated with contraception use (adjusted odds ratio (aOR) = 1.93, 95% CI: 1.64-2.27, p = 0.0001). Among those using contraception, experiencing two or three types of spousal violence was associated with using pills (adjusted risk ratio (aRRR) = 2.12, 95% CI: 1.63-2.77, p = 0.0001), injections (aRRR = 1.75, 95% CI: 1.26-2.41, p = 0.001), and LAM (aRRR = 3.27, 95% CI: 2.05-5.20, p = 0.0001), compared to male-involved methods., Conclusions: The findings of this study may inform policymakers and program implementers in designing interventions to address the pervasive problem of violence against women, and make pills and injectables more accessible to Afghan women, since these methods are under women's control and more often used in Afghanistan.

Background: Systemic progress in improving trial representation is uncertain, and previous analyses of minority trial participation have been limited to small cohorts with limited exploration of driving factors., Methods: We analyzed detailed trial records from all US clinical trials registered in ClinicalTrials.gov from March 2000 to March 2020. Minority enrollment was compared to 2010 US Census demographic estimates using Wilcoxon test. We utilized logistic regression and generalized linear regression with a logit link to assess the association of possible drivers (including trials' funding source, size, phase, and design) with trials' disclosure of and amount of minority enrollment respectively., Findings: Among 20,692 US-based trials with reported results (representing ~4·76 million enrollees), only 43% (8,871/20,692) reported any race/ethnicity data. The majority of enrollees were White (median 79·7%; interquartile range [IQR] 61·9-90·0%), followed by Black (10·0%; IQR 2·5-23·5%), Hispanic/Latino (6·0%; IQR 0·43-15·4%), Asian (1·0%; IQR 0·0-4·1%), and American Indian (0·0%; IQR 0·0-0·2%). Median combined enrollment of minority race/ethnicity groups (Black, Hispanic/Latino, Asian, American Indian, Other/Multi) was below census estimates (27·6%) (p<0·001) however increased at an annual rate of 1·7%. Industry and Academic funding were negatively associated with race/ethnicity reporting (Industry adjusted odds ratio [aOR]: 0·42, 95% confidence interval [CI]: 0·38 to 0·46, p<0.0001; Academic aOR: 0·45, CI: 0·41 to 0·50, p<0.0001). Industry also had a negative association with the proportion of minority ethnicity enrollees (aOR: 0·69, CI: 0·60 to 0·79) compared to US Government-funded trials., Interpretation: Over the past two decades, the majority of US trials in ClinicalTrials.gov do not report race/ethnicity enrollment data, and minorities are underrepresented in trials with modest improvement over time., Funding: Stanford Medical Scholars Research Funding, the National Heart, Lung, and Blood Institute, NIH (1K01HL144607) and the American Heart Association/Robert Wood Johnson Medical Faculty Development Program.

Objective: To characterize gynecology clinical trials over time, compare gynecology subspecialties, and analyze factors associated with early discontinuation, results reporting, and publication., Methods: We conducted a cross-sectional analysis of all gynecology trials registered on ClinicalTrials.gov between 2007 and 2020 and their resulting publications. Trials were analyzed with descriptive, multivariable logistic, and Cox regression analyses. Primary exposure variables were trial funding and subspecialty. The three primary outcomes included early discontinuation, results reporting to ClinicalTrials.gov, and publication in a peer-reviewed journal indexed on PubMed., Results: Of 223,690 trials registered on ClinicalTrials.gov between October 2007 and March 2020, only 3.7% focused on gynecology (n=8,174, approximately 3,759,086 participants). Subspecialties included reproductive endocrinology and infertility (n=1,428, 17.5%), gynecologic oncology (n=2,063, 25.2%), urogynecology (n=1,118, 13.7%), family planning (n=648, 7.9%), and other benign gynecology (n=2,917, 35.7%). Only 42.0% of completed trials disseminated results through results reporting and publication. Of all funding types, industry-funded trials were the most likely to be discontinued early (P<.001). Academic-funded trials were the least likely to report results (adjusted odds ratio [aOR] 0.38, 95% CI 0.30-0.50) but the most likely to publish (aOR 1.62, 95% CI 1.24-2.12). The number of reproductive endocrinology and infertility trials increased the most of any subspecialty between 2007 and 2020 (6.4% growth rate). Reproductive endocrinology and infertility and family planning trials were the most likely to be stopped early (reproductive endocrinology and infertility: adjusted hazard ratio [aHR] 2.08, 95% CI 1.59-2.71; family planning: aHR 1.55 95% CI 1.06-2.25). When completed, reproductive endocrinology and infertility trials were the least likely to report results (aOR 0.58, 95% CI 0.38-0.88). No significant differences were seen between subspecialties with respect to publication., Conclusion: Gynecology trials comprise only 3.7% of all clinical trials. The paucity of gynecology clinical trials aligns with decades of female underrepresentation in research. When completed, gynecology trials have poor dissemination. Our findings raise concern about bias in the performance, reporting, and publication of gynecology clinical trials., Competing Interests: Financial Disclosure Magdy P. Milad disclosed that they have served on the advisory board for Myovant Baxter Doximity, received grant money for the Empower endometriosis study (Storz research grant), and they also do medicolegal work. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background and Objectives: Unique ethical, epidemiological, and economic factors are barriers to performing research in children. The landscape of pediatric clinical trials, including drivers of completion and timely dissemination of results, is not well understood. We aimed to characterize the prevalence of and factors associated with early discontinuation, results reporting, and publication of pediatric clinical trials registered at ClinicalTrials.gov., Methods: Cross-sectional analysis of clinical trials enrolling participants <18 years old registered at ClinicalTrials.gov from October 2007 to March 2020. Multivariable logistic regressions were performed to assess the association between trial characteristics and primary outcomes. Publication data were obtained through PubMed, ClinicalTrials.gov, Embase, and Scopus., Results: Overall, 11.1% trials were stopped early, with recruitment failure being the predominant reason for discontinuation. Only 23.5% of completed trials reported results, and 38.8% were published within 3 years of completion. Rates of discontinuation and publication significantly improved over the study period. Among funding sources, government-sponsored trials (adjusted odds ratio [aOR], 0.72; 95% CI, 0.47-0.97) and academic trials (aOR, 0.64; 95% CI, 0.50-0.82) had lower odds of discontinuation compared with industry trials and were more likely to be published (government: aOR, 1.94 [95% CI, 1.52-2.48] academic: aOR, 1.61 [95% CI, 1.35-1.92). Academic trial investigators were the least likely to report results (aOR, 0.34; 95% CI, 0.31-0.52)., Conclusions: Early discontinuation and nonreporting/nonpublication of findings remain common in registered pediatric clinical trials and were associated with funding source and other trial features. Targeted efforts are needed to support trial completion and timely results dissemination toward strengthening evidence-based pediatric medicine., Competing Interests: CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no conflicts of interest relevant to this article to disclose., (Copyright © 2022 by the American Academy of Pediatrics.)

Objective: Among women initiating new prescription contraception, we investigated the relationship between recent depression and a range of contraceptive behaviors., Study Design: We used medical and pharmacy records of 52,325 women ages 19 to 29 who initiated prescription contraception (pills, patches or rings, injectables, and long-acting reversible contraceptives) in 2014-2016 at a large integrated healthcare system in Northern California. Women had continuous enrollment for a year before and after initiating, and no records of prescription contraceptive use in the year before initiating. Depression in the year prior to initiation was dichotomized into (1) no depression indicator (reference group) or (2) depression diagnosis or redeemed antidepressant. Multinomial logistic regression models examined the associations between depression and method type initiated, and contraceptive patterns, timing of discontinuation, inconsistent use, and switching methods over a year after initiating, adjusting for sociodemographics and testing for interactions between depression and having a recent birth or abortion., Results: Women with recent depression were more likely to initiate methods other than the pill, and the association was stronger for patches or rings vs pills among those with a recent birth compared to those without. Among women initiating all methods and the pill, those with depression were more likely to discontinue their method, use it inconsistently, and switch from it than use it continuously for a year., Conclusion: Women with recent depression were less likely to initiate the pill; and when the pill was initiated, those with depression were more likely to discontinue use, use it inconsistently, and switch from it., Implications: Women with recent depression indicators should be followed closely to ensure they have the support they need to meet their reproductive goals. Those who wish to avoid pregnancy may benefit from methods that do not require daily use., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Disparities in children's school readiness (SR) in the U.S. are well-documented and have detrimental long-term consequences. Clinic-based early education interventions are limited. This report summarizes collaborative efforts of pediatricians and community stakeholders to develop and implement clinic-based interventions to promote early learning and SR among low-income children.

Introduction: Vaccine hesitancy (VH), delay in acceptance, and/or refusal to vaccinate is influenced by complacency, confidence, unmet safety, and efficacy concerns. A survey was conducted among U.S. healthcare students to identify factors contributing to COVID-19 vaccine hesitancy., Methods: The World Health Organization 2014 vaccine hesitancy guidelines informed development of a 37-item survey. This cross-sectional survey was distributed to students in 10 randomly selected nursing, pharmacy, and medical programs. Descriptive statistics and logistic regression were used to identify factors contributing to COVID-19 vaccine hesitancy., Results: Of the 902 participants who started the survey, 398 completed all COVID-19 questions. Survey respondents were primarily from private schools (84%) and consisted of medical students (49%), female (71%), and millennials (57%). Students believed COVID-19 vaccine was important and protection of vulnerable communities more important than individual protection. Students in general agreed getting the vaccine was necessary to protect others (school and healthcare facilities) (77.4%); only one-third (33.7%) disagreed that they planned to wait and want to see how vaccine affected others before receiving it. Logistic regression results suggest significant differences based on program and political affiliation., Conclusions: Engagement of healthcare students may help reach student peers who are vaccine hesitant and help reduce the spread of COVID-19.

Background and Objectives: Children entering kindergarten ready to learn are more likely to thrive. Inequitable access to high-quality, early educational settings creates early educational disparities. TipsByText, a text-message-based program for caregivers of young children, improves literacy of children in preschool, but efficacy for families without access to early childhood education was unknown., Methods: We conducted a randomized controlled trial with caregivers of 3- and 4-year-olds in 2 public pediatric clinics. Intervention caregivers received TipsByText 3 times a week for 7 months. At pre- and postintervention, we measured child literacy using the Phonological Awareness Literacy Screening Tool (PALS-PreK) and caregiver involvement using the Parent Child Interactivity Scale (PCI). We estimated effects on PALS-PreK and PCI using multivariable linear regression., Results: We enrolled 644 families, excluding 263 because of preschool participation. Compared with excluded children, those included in the study had parents with lower income and educational attainment and who were more likely to be Spanish speaking. Three-quarters of enrollees completed pre- and postintervention assessments. Postintervention PALS-PreK scores revealed an unadjusted treatment effect of 0.260 ( P = .040); adjusting for preintervention score, child age, and caregiver language, treatment effect was 0.209 ( P = .016), equating to ∼3 months of literacy gains. Effects were greater for firstborn children (0.282 vs 0.178), children in 2-parent families (0.262 vs 0.063), and 4-year-olds (0.436 vs 0.107). The overall effect on PCI was not significant (1.221, P = .124)., Conclusions: The health sector has unique access to difficult-to-reach young children. With this clinic-based texting intervention, we reached underresourced families and increased child literacy levels., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2021 by the American Academy of Pediatrics.)

Background: Increasing neurological disease burden and advancing treatment options require clinical trials to expand the evidence base of clinical care. We aimed to characterize neurology clinical trials registered between October 2007 and April 2018 and identify features associated with early discontinuation and results reporting., Methods: We compared 16,994 neurology (9.4%) and 163,714 non-neurology comparison trials registered to ClinicalTrials.gov. Trials therapeutic focus within neurology was assigned via combination programmatic and manual review. We performed descriptive analyses of trial characteristics, cox regression of early discontinuation, and multivariable logistic regression for results reporting within 3 years of completion., Results: Most neurology trials were academic-funded (58.5%) followed by industry (31.9%) and US-government (9.6%). Neurology trials focused more on treatment than prevention compared to non-neurology studies. Of neurology trials, 11.3% discontinued early, and 32.2% of completed trials reported results by April 30, 2018. In multivariable analysis accounting for time-to-event, neurology trials were at lower risk of discontinuation than non-neurology trials (adjusted hazard 0.83, p < 0.0001). Both academic and government-funded trials had greater risk of discontinuation than industry (adjusted hazard 0.57 and 0.46, respectively). Among completed trials, government-funded studies (adjusted odds ratio 2.12, p < 0.0001) had highest odds of results reporting while academic trials reported less (adjusted odds ratio 0.51, p < 0.0001)., Conclusions: Funding source is associated with trial characteristics and outcomes in neurology. Improvements in trial completion and timely dissemination of results remain urgent goals for the field., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objective: We examined whether contraceptive method type, satisfaction with use, and confidence in correct use were independently associated with switching intentions, a precursor of switching behaviors., Study Design: Data were from a probability-based sample survey carried out in Delaware and Maryland in 2016 and 2017 among women ages 18 to 44. Women's current contraceptive methods were classified into 5 categories: coitally-dependent methods (barrier methods, withdrawal, and natural family planning); oral contraceptive pills, patches, and rings; injections; implants; and intrauterine contraception (IUC). Satisfaction, confidence, and switching intentions were dichotomized into being very versus less satisfied, being completely versus less confident, and having very low versus not very low switching intentions. We conducted binomial logistic regression to examine whether method type, satisfaction, and confidence were independently associated with having very low switching intentions, adjusting for a range of covariates including sociodemographics, perceived health, religious attendance frequency, sexual, contraceptive, and reproductive experiences, and state of residence (Maryland or Delaware)., Results: Among 1,077 women using reversible contraception, those using IUC relative to implants, pills, patches, or rings, and coitally-dependent methods were more likely to have very low switching intentions. Among all survey respondents, those who were very satisfied and those who were completely confident in correct use were also more likely to report very low switching intentions., Conclusions: Using IUC, being very satisfied, and being very confident in correct use were independently associated with having very low switching intentions., Implications: These results suggest that those using IUC have very low intentions to switch for reasons in addition to satisfaction-level with their method. Other aspects of using IUC such as ease of use, perceived barriers to switching, or having very low switching intentions before beginning IUC may be such reasons., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Intimate partner violence and differential power dynamics are associated with contraceptive behaviors. This study examines the role of reproductive coercion (RC) by an intimate partner in women's decisions about contraceptive use. Materials and Methods: A self-report survey was administered to a probability sample of a diverse group of women of reproductive age in Delaware's Title X health care facilities. Currently used contraceptive methods were categorized into three effectiveness levels based on typical use failure rates: no method or low effectiveness (>10% failure), moderate effectiveness (>1% and <10% failure), and high effectiveness (<1% failure). The short-form RC scale was used to categorize RC experiences: no RC, verbal only, or behavioral. We conducted multinomial logistic regression to examine the association between types of RC and effectiveness level of current contraceptive method, taking our sampling design into account and adjusting for covariates. Results: Among 240 women (weighted n  = 6529) included in the sample, 13.9% reported experiencing only verbal RC, and 16.1% reported behavioral RC. Women who reported behavioral RC were more likely to currently be using highly versus moderately (adjusted relative risk ratio [aRRR]: 26.71, 95% confidence interval [CI]: 4.59-156.0) and low effective methods (aRRR: 3.08, 95% CI: 0.97-9.82), but less likely to be using moderately (aRRR: 0.12, 95% CI: 0.02-0.77) than low effective methods. Conclusions: Using highly and low effective methods may indicate two opposing ways of managing behavioral RC experiences: controlling fertility by choosing less detectable but highly effective methods or feeling disempowered and using no or low effective partner-dependent methods.

Importance: Although female representation has increased in clinical trials, little is known about how clinical trial representation compares with burden of disease or is associated with clinical trial features, including disease category., Objective: To describe the rate of sex reporting (ie, the presence of clinical trial data according to sex), compare the female burden of disease with the female proportion of clinical trial enrollees, and investigate the associations of disease category and clinical trial features with the female proportion of clinical trial enrollees., Design, Setting, and Participants: This cross-sectional study included descriptive analyses and logistic and generalized linear regression analyses with a logit link. Data were downloaded from the Aggregate Analysis of ClinicalTrials.gov database for all studies registered between March 1, 2000, and March 9, 2020. Enrollment was compared with data from the 2016 Global Burden of Disease database. Of 328 452 clinical trials, 70 095 were excluded because they had noninterventional designs, 167 936 because they had recruitment sites outside the US, 69 084 because they had no reported results, 1003 because they received primary funding from the US military, and 314 because they had unclear sex categories. A total of 20 020 interventional studies enrolling approximately 5.11 million participants met inclusion criteria and were divided into those with and without data on participant sex., Exposures: The primary exposure variable was clinical trial disease category. Secondary exposure variables included funding, study design, and study phase., Main Outcomes and Measures: Sex reporting and female proportion of participants in clinical trials., Results: Among 20 020 clinical trials from 2000 to 2020, 19 866 studies (99.2%) reported sex, and 154 studies (0.8%) did not. Clinical trials in the fields of oncology (46% of disability-adjusted life-years [DALYs]; 43% of participants), neurology (56% of DALYs; 53% of participants), immunology (49% of DALYs; 46% of participants), and nephrology (45% of DALYs; 42% of participants) had the lowest female representation relative to corresponding DALYs. Male participants were underrepresented in 8 disease categories, with the greatest disparity in clinical trials of musculoskeletal disease and trauma (11.3% difference between representation and proportion of DALYs). Clinical trials of preventive interventions were associated with greater female enrollment (adjusted relative difference, 8.48%; 95% CI, 3.77%-13.00%). Clinical trials in cardiology (adjusted relative difference, -18.68%; 95% CI, -22.87% to -14.47%) and pediatrics (adjusted relative difference, -20.47%; 95% CI, -25.77% to -15.16%) had the greatest negative association with female enrollment., Conclusions and Relevance: In this study, sex differences in clinical trials varied by clinical trial disease category, with male and female participants underrepresented in different medical fields. Although sex equity has progressed, these findings suggest that sex bias in clinical trials persists within medical fields, with negative consequences for the health of all individuals.

Purpose: Clinical trials require significant resources, but benefits are only realized after trial completion and dissemination of results. We comprehensively assessed early discontinuation, registry results reporting, and publication by trial sponsor and subspecialty in urology trials., Materials and Methods: We assessed trial registrations from 2007 to 2019 on ClinicalTrials.gov and publication data from PubMed®/MEDLINE®. Associations between sponsor or subspecialty with early discontinuation were assessed using Cox proportional hazards and results reporting or publication with logistic regression at 3 years after completion., Results: Of 8,636 trials 3,541 (41.0%) were completed and 999 (11.6%) were discontinued. Of completed trials 26.9% reported results and 21.6% were published. Sponsors included academic institutions (53.1%), industry (37.1%) and the U.S. government (9.8%). Academic-sponsored (adjusted HR 0.81, 95% CI 0.69-0.96, p=0.012) and government-sponsored trials (adjusted HR 0.62, 95% CI 0.49-0.78, p <0.001) were less likely than industry to discontinue early. Government-sponsored trials were more likely to report (adjusted OR 1.72, 95% CI 1.17-2.54, p=0.006) and publish (adjusted OR 1.89, 95% CI 1.23-2.89, p=0.004). Academic-sponsored trials were less likely to report (adjusted OR 0.65, CI:0.48-0.88, p=0.006) but more likely to publish (adjusted OR 1.72, 95% CI 1.25-2.37, p <0.001). These outcomes were similar across subspecialties. However, endourology was more likely to discontinue early (adjusted HR 2.00, 95% CI 1.53-2.95, p <0.001), general urology was more likely to report results (adjusted OR 1.54, 95% CI 1.13-2.11, p=0.006) and andrology was less likely to publish (adjusted OR 0.53, 95% CI 0.35-0.81, p=0.003)., Conclusions: Sponsor type is significantly associated with trial completion and dissemination. Government-sponsored trials had the best performance, while industry and academic-sponsored trials lagged in completion and results reporting, respectively. Subspecialty played a lesser role. Lack of dissemination remains a problem for urology trials.

Background: Obstetrical complications affect more than a third of women globally, but are underrepresented in clinical research. Little is known about the comprehensive obstetrical clinical trial landscape, how it compares with other fields, or factors associated with the successful completion of obstetrical trials., Objective: This study aimed to characterize obstetrical clinical trials registered on ClinicalTrials.gov with the primary objective of identifying features associated with early discontinuation and results reporting., Study Design: This is a cross-sectional study with descriptive, logistic regression and Cox regression analyses of clinical trials registered on ClinicalTrials.gov. Our primary exposure variables were trial focus (obstetrical or nonobstetrical) and trial funding (industry, United States government, or academic). We conducted additional exploratory analyses of other trial features including design, enrollment, and therapeutic focus. We examined the associations of exposure variables and other trial features with 2 primary outcomes: early discontinuation and results reporting., Results: We downloaded data for all studies (N=332,417) registered on ClinicalTrials.gov from October 1, 2007, to March 9, 2020, from the Aggregate Analysis of ClinicalTrials.gov database. We excluded studies with a noninterventional design (n=63,697) and those registered before October 1, 2007 (n=45,209). A total of 4276 obstetrical trials (1.9%) (ie, interventional studies) and 219,235 nonobstetric trials (98.1%) were compared. Among all trials, 2.8% of academic-funded trials, 1.9% of United States government-funded trials, and 0.4% of industry-funded trials focused on obstetrics. The quantity of obstetrical trials increased over time (10.8% annual growth rate). Compared with nonobstetrical trials, obstetrical trials had a greater risk of early discontinuation (adjusted hazard ratio, 1.40; 95% confidence interval, 1.21-1.62; P <.0001) and similar odds of results reporting (adjusted odds ratio, 0.89; 95% confidence interval, 0.72-1.10; P =.19). Among obstetrical trials funders after controlling for confounding variables, United States government-funded trials were at the lowest risk of early discontinuation (United States government, adjusted hazard ratio, 0.23; 95% confidence interval, 0.07-0.69; P =.009; industry reference; academic, adjusted hazard ratio, 1.04; 95% confidence interval, 0.62-1.74; P =.88). Academic-funded trials had the lowest odds of results reporting after controlling for confounding variables (academic institutions, adjusted odds ratio, 0.39; 95% confidence interval, 0.22-0.68; P =.0009; industry reference; United States government, adjusted odds ratio, 1.06; 95% confidence interval, 0.53-2.09; P =.87)., Conclusion: Obstetrical trials represent only 1.9% of all clinical trials in ClinicalTrials.gov and have comparatively poor completion. All stakeholders should commit to increasing the number of obstetrical trials and improving their completion and dissemination to ensure clinical research reflects the obstetrical burden of disease and advances maternal health., (© 2020 Elsevier Inc. All rights reserved.)

Background: Diversifying the surgical workforce is a critical component of improving care for underserved patients. To recruit surgeons from diverse backgrounds, we must understand how medical students choose their specialty. We investigate how preclinical students contemplate entering a surgical field., Materials and Methods: We conducted semistructured focus groups during two iterations of a seminar class called Service Through Surgery. Discussion goals included identifying student values and assessing how they inform early career decisions. We used a systematic, collaborative, and iterative process for transcript analysis, including developing a codebook, assessing inter-rater reliability, and analyzing themes., Results: Twenty-four preclinical medical students from diverse backgrounds participated in seven focus groups; most were women (16; 67%), in their first year of medical school (19; 79%), and interested in surgery (17; 71%). Participants ranked professional fulfillment, spending time with family, and serving their communities and/or underserved populations among their most important values and agreed that conducting groundbreaking research, working long hours, and finding time for leisure activities were the least important. We constructed a framework to describe student responses surrounding their diverse visions for service in future surgical careers through individual doctoring interactions, roles in academia, and broader public service., Conclusions: Our framework provides a basis for greater understanding and study of the ways in which preclinical medical students think about their personal values and visions for service in potential future surgical careers. This research can guide early interventions in medical education to promote diversity and care for the underserved in surgery., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: We examined whether experiencing more types of lifetime intimate partner violence (IPV) was independently associated with the effectiveness level of the contraceptive method women chose following an abortion. Materials and Methods: Using data on 245 women who were attending an urban hospital abortion clinic, we assessed whether women had ever experienced emotional, physical, or sexual IPV. Effectiveness of women's post-abortion contraceptive method selection was categorized into high (intrauterine device [IUD] and implant), moderate (pill, patch, ring, and shot), and low (condoms, emergency contraception, and none) effectiveness. Using multinomial logistic regression, we examined the relationship between number of types of IPV experienced and post-abortion contraceptive method effectiveness, adjusting for sociodemographics, prior abortion, having children, abortion trimester, importance of avoiding pregnancy in the next year, pre-abortion psychological distress, and effectiveness level of the contraceptive method women were planning to use before contraceptive counseling. Results: Twenty-seven percent (27%) of women experienced two or three types of IPV, 35% experienced one IPV type, and 38% experienced no IPV. Compared to women with no histories of IPV, women who experienced two or more types of IPV during their lifetimes were more likely to choose contraceptive methods with moderate effectiveness (adjusted odds ratio [AOR] = 5.23, 95% confidence interval [CI]: 1.13-24.23, p  = 0.035) and high effectiveness (AOR = 5.01, 95% CI: 1.12-22.39, p  = 0.035) than those with low effectiveness. Conclusion: Women who experienced two or more types of lifetime IPV selected more effective contraceptive methods post-abortion. Access to contraceptives that are not partner dependent, including long-acting reversible contraceptives (LARC), may be particularly important for women who have experienced multiple types of IPV.

Purpose: This study aimed to examine whether the timing of depression onset relative to age at sexual debut is associated with teenage pregnancy., Methods: Using data from 1,025 adolescent girls who reported having had sex in the National Comorbidity Survey-Adolescent Supplement, we applied cox proportional hazards models to test whether depression onset before first sex, at the same age as first sex, or after first sex compared with no depression onset was associated with experiencing a first teenage pregnancy. We examined the unadjusted risk by depression status as well as risk adjusted for adolescents' race/ethnicity, marital status, poverty level, whether the adolescent lived in a metropolitan area, living status, age at first sex, parental education, and age of mother when the adolescent was born., Results: In both unadjusted and adjusted models, we found that adolescents with depression onset at the same age as having initiated sex were at an increased risk of experiencing a teenage pregnancy (unadjusted hazard ratio [HR] = 2.5, 95% confidence interval [CI]: 1.08-5.96; adjusted HR = 2.7, 95% CI: 1.15-6.34) compared with those with no depression onset. Moreover, compared with those with no depression onset, the risk of pregnancy for girls experiencing depression onset before first sex also increased but was not significant (adjusted HR = 1.5, 95% CI: .82-2.76)., Conclusions: Timing of first depressive episode relative to age at first sexual intercourse plays a critical role in determining the risk of teenage pregnancy. Timely diagnosis and treatment of depression may not only help adolescents' mental well-being but may also help them prevent teenage pregnancy., (Copyright © 2020 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Increased surgical workforce diversity diminishes health disparities., Methods: Researchers recruited and nonrandomly enrolled participants into intervention and comparison groups for a quasi-experimental study of the impact of a seminar course on student exposure to diverse mentorship and service through surgery. All metrics were analyzed with chi-squared and paired t-tests., Results: 109 students participated (34 intervention, 75 comparison). There were significant differences in the percentage of participants that newly met a surgeon of their race (intervention, comparison: 100%, 25%), their race and gender (80%, 21%), their religion (23%, 9%), and who completed health disparities research (90%, 45%, p-value for all <0.05). There was a nonsignificant change in participants' attitudes towards underserved populations in intervention and comparison groups., Conclusions: This preclinical surgery seminar course increased exposure of underrepresented students to surgeons from diverse backgrounds and may impact student attitudes towards the underserved. This class represents a replicable model for increasing mentorship., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To examine whether depression, intimate partner violence, and other psychosocial stressors were independently associated with effectiveness level of postpartum contraception among women who recently had an unintended birth., Methods: We analyzed cross-sectional data from PRAMS (the Pregnancy Risk Assessment Monitoring System) to identify women who had an unintended birth between 2012 and 2015. The effectiveness level of the contraceptive method was coded into one of five categories based on the postpartum contraceptive method that women were using: none, less effective (withdrawal, rhythm, condoms, or other barrier), moderately effective (pill, patch, ring, or shot), long-acting reversible contraception (LARC; intrauterine devices or implants), and sterilization (female or male sterilization). Multinomial logistic regression was used to examine whether prepregnancy depression or elevated postpartum depressive symptoms, intimate partner violence before or during pregnancy, and number of psychosocial stressors before birth were associated with effectiveness level of method (compared with no method), in models adjusted for sociodemographics, pregnancy context, and postpartum context., Results: Complete data were available for 56,445 (88.2%) of the 64,030 eligible women: 24.2% experienced depression; 5.3% experienced intimate partner violence; and 16.8% experienced five or more psychosocial stressors around the time of pregnancy or birth. In adjusted models, experiencing intimate partner violence and more stressors lowered women's relative risk of using sterilization, LARC, moderately effective methods, and less-effective contraceptive methods relative to no method use. Only prepregnancy depression was associated with using sterilization compared with no method use., Conclusions: Experiencing intimate partner violence and having more psychosocial stressors were each independently associated with not using a postpartum contraceptive method. Standardized screening for psychosocial factors during prenatal and postpartum care should be integrated, and practices that encourage the discussion of patients' psychosocial experiences and postpartum contraception use together are warranted.

A recent analysis from the Turnaway study focused on women who were just under the gestational limit of a clinic and received an abortion and those who had first trimester abortions to examine trends in decisional rightness and negative and positive emotions over 5 years after the abortion. Specifically, Rocca et al. (in press) analyzed these data and found that women were overwhemingly sure of their decision: 95% felt their decision was the right one at each assessment after their abortion, and the predicted probability of abortion being the right decision was 99% at 5 years afterwards. Relief was the most common emotion felt by women, and negative emotions or decision regret did not emerge over time. These results and others from studies conducted globally counter assertions by abortion opponents that women are not certain of their decisions, or that women regret or have mainly negative emotions about their abortions if not in the short run then after a long period of time. This commentary addresses not only these findings but also relevant U.S. abortion policies based on these unsubstantiated claims. Policies should not be based on the notions that women are unsure of their decision, come to regret, it or have negative emotions because there is no evidence to support these claims., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Suicidal ideation due to abortion has been used to justify restrictive US abortion policies. Much research examining abortion and mental health has relied on self-report, has had low participation rates, and did not consider confounding factors. In the present study, we used data that do not rely on self-report and are not affected by low participation rates to examine the association between abortion and non-fatal suicide attempts, adjusting for confounding factors., Methods: In this longitudinal cohort study of Danish population registries, we linked data on a cohort of women born in Denmark between Jan 1, 1980, and Dec 30, 1998, who did not die or emigrate from Denmark before their 18th birthday or before study entry. Follow-up started on the woman's 18th birthday or Jan 1, 2000, whichever came last. Follow-up ended at the date of first suicide attempt, date of emigration from Denmark, date of death, or Dec 31, 2016, whichever came first. Women were between the ages of 18 and 36 years during the study period. We used a survival analysis to examine the risk of first suicide attempts or self-harm associated with a first abortion compared with no abortion, in the complete study cohort. To examine incidence rate ratios (IRRs) associated with abortion, we used Poisson regression with the logarithm of woman-years at risk as an offset. We also examined whether the risk of suicide attempts changed before and after the abortion, adjusting for age, calendar year, socioeconomic status, and history of childbirth, mental health, parental mental health, and physical health., Findings: Data on 523 280 women were included in this study. Of these, 48 990 (9·4%) women had a record of at least one first-trimester abortion, and 10 216 (2·0%) had a suicide attempt during the study period. Among 48 990 women who had an abortion, 1402 (2·9%) had a first suicide attempt after the first abortion. In our fully-adjusted model which adjusted for all covariates, the risk of first-time non-fatal suicide attempts was similar in the year before an abortion (IRR 2·46 [95% CI 2·22-2·72]) and the year after an abortion (IRR 2·54 [2·29-2·81], p=0·509) compared with women who had not had an abortion, and decreased with increasing time since the abortion (1-5 years IRR 1·90 [1·75-2·06]; ≥5 years IRR 1·73 [1·53-1·96])., Interpretation: We found that women who had abortions had a higher risk of non-fatal suicide attempts compared with women who did not have an abortion. However, because the increased risk was the same both the year before and after the abortion, it is not attributable to the abortion. Thus, policies based on the notion that abortion increases women's risk of suicide attempts are misinformed., Funding: Society of Family Planning, American Foundation for Suicide Prevention, and The Lundbeck Foundation Initiative for Integrative Psychiatric Research., (Copyright © 2019 Elsevier Ltd. All rights reserved.)