Underrepresentation of racial and ethnic minority groups in gynecologic oncology: An analysis of over 250 trials.

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.

Informational Preferences of Women Seeking Treatment for Symptomatic Uterine Fibroids: A Qualitative Study.

STUDY OBJECTIVE: To establish the informational needs and preferences of women navigating treatment options for symptomatic uterine fibroids. DESIGN: Qualitative study using semistructured interviews. SETTING: Academic institution. PATIENTS: Participants had a diagnosis of symptomatic uterine fibroids with an active treatment plan. INTERVENTIONS: Semistructured video interviews were conducted with female patients undergoing treatment for symptomatic uterine fibroids (n = 20). Women were recruited from the outpatient Center for Complex Gynecology in Chicago, IL. Interviews were recorded and transcribed verbatim. A codebook was developed based on the interview transcripts, and the finalized coding was used to conduct a thematic analysis. MEASUREMENTS AND MAIN RESULTS: Four distinct themes emerged from the interviews: (1) Social supports-including social media-play an important role in informing patients' treatment choices; (2) Patients spend significant energy seeking additional information beyond their obstetrician-gynecologist; (3) Patients prioritize receiving full and complete information from their provider; and (4) Patients experience information-related delays in receiving care. CONCLUSION: Patients seeking care for symptomatic uterine fibroids have strong preferences about both the quality and extent of information they receive from their gynecologists. Physicians treating these conditions must adapt to changing informational desires and consider expanding physician engagement with patients' social media needs.

Race and Ethnicity Reporting and Representation in Obstetrics and Gynecology Clinical Trials and Publications From 2007-2020.

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.

How many US obstetrical trials reach publication? A cross-sectional analysis of ClinicalTrials.gov and PubMed from 2007 to 2019.

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.

Perspectives of internal medicine physicians regarding medication abortion provision in the primary care setting.

OBJECTIVE: To better understand medication abortion attitudes and interest in future provision among Internal Medicine primary care providers (IM PCPs), and to characterize barriers to provision. STUDY DESIGN: We conducted a survey with IM attendings and trainees at a large academic medical center in Western Pennsylvania. We used descriptive statistics to characterize attitudes towards medication abortion provision, including the belief that it is within their scope of practice and interest in future provision, and to explore perceived barriers to provision. We used logistic regression models to assess factors associated with each of these attitudes. RESULTS: Of 397 eligible attendings and trainees, 121 (30%) completed the survey. Among those surveyed, 44% believed medication abortion is within the scope of practice of IM PCPs with trainees and female-identifying providers being significantly more likely to believe medication abortion is within their scope of practice compared to attending physicians and male physicians (60% vs 30%, p < 0.01 and 53% vs 31%, p = 0.01, respectively). Similarly, 43% endorsed interest in future provision, with trainees (67% vs 23%, p < 0.001) and female providers (54% vs 27%, p = 0.002) being more likely to express interest. The most cited barriers to provision included limited training in residency (70%) and low familiarity with abortion medications (57%). CONCLUSIONS: Many IM providers- particularly trainees- believe medication abortion is within their scope of practice and would like to provide this care. Interventions are needed to provide education and assistance complying with state and federal regulations to enable safe and efficient medication abortion provision by IM providers. IMPLICATIONS: IM departments and residency programs should seek to ensure training is offered to clinicians interested in providing medication abortion as a part of their primary care practice.

Exploring the Preferences of Women Regarding Sexual and Reproductive Health Care in the Context of Rheumatology: A Qualitative Study.

OBJECTIVE: To explore the sexual and reproductive health (SRH) care and counseling needs of young women with rheumatic diseases in the context of their rheumatology care. METHODS: Semistructured qualitative telephone interviews were conducted with female patients with rheumatic diseases ages 18-45 years (n = 30). Women were recruited from outpatient rheumatology clinics in western Pennsylvania. Interviews were audiorecorded and transcribed verbatim. A codebook was inductively developed based on the interview transcripts, and the finalized coding was used to conduct a thematic analysis. RESULTS: Four themes emerged from interviews: 1) women want rheumatologists to initiate conversations about SRH and to revisit the conversation over time; 2) women desire clear and complete information regarding fetal, pregnancy, and infertility risks associated with their diseases and disease-modifying antirheumatic drugs (DMARDs); 3) women want to be treated holistically, with SRH addressed in the context of their life circumstances and personal values in addition to their rheumatic diseases; 4) women generally feel that they are intermediaries between their rheumatologists and obstetrician-gynecologists (OB/GYNs), but preferred for providers to communicate directly with one another about their SRH. CONCLUSION: Patients strongly desired rheumatologists to play an active role in their SRH, by initiating family planning conversations, providing SRH education in the context of their diseases and DMARDs, and directly coordinating SRH care with OB/GYNs. To meet patients' SRH needs, further work is needed to clarify the specific role of rheumatologists in providing SRH care and to identify ways to better facilitate communication between rheumatologists and reproductive health care providers.

Contraception decision-making and care among reproductive-aged women with autoimmune diseases.

OBJECTIVE: In this qualitative study, we sought to understand better the contraception-related experiences and decision-making of women with autoimmune diseases, a group at high risk for adverse pregnancy and perinatal outcomes. STUDY DESIGN: We conducted semi-structured telephone interviews with women ages 18 to 45 who had at least one autoimmune disease diagnosis. Our team recruited from outpatient rheumatology clinics in Pittsburgh, Pennsylvania. We analyzed our data for content and themes, using inductive and deductive techniques and the constant comparison approach. RESULTS: The 30 women in the sample ranged from 25 to 44 years old; most were white (73%), married (52%), and had at least one child (53%). Four themes emerged from our interviews: (1) Women's decisions to use contraception were strongly influenced by their diseases and perceptions of their health; (2) Women felt that hormonal contraception was unsafe in the context of their diseases, even women without clear disease-related health risks; (3) Health care providers influenced women's consideration and selection of contraceptive methods; (4) Women rarely expected that their rheumatologists would prescribe their contraception, yet their contraception prescribers lacked knowledge about their disease-specific health risks. CONCLUSIONS: Women perceived that hormonal contraception is unsafe in the context of their autoimmune diseases and cited medication fatigue and safety concerns as reasons why they did not use contraception. Some women did not appear to receive patient-centered contraception counseling from providers. Our interviews reveal areas for improving contraception care, including augmenting shared decision-making and educating patients and providers about contraception safety. IMPLICATIONS: Our findings highlight potential tensions between patients' preferences for contraception, safety considerations, and ethical and medically responsible contraception care by health care providers in the rheumatology context. Future work is needed to develop person-centered, medically-appropriate models for contraception care that meet the needs of medically vulnerable populations.

Agreement between Self-Reported "Ideal" and Currently Used Contraceptive Methods among Women Veterans Using the Veterans Affairs Healthcare System.

BACKGROUND: Women veterans who use the Veterans Affairs Healthcare System theoretically have access to the full range of contraceptive methods. This study explores match between currently used and self-reported "ideal" methods as a potential marker of contraceptive access and preference matching. METHODS: This mixed methods study uses data from a nationally representative survey of reproductive-aged women veterans who use the Veterans Affairs Healthcare System for primary care, including 979 participants at risk of unintended pregnancy. Women reported all contraceptive methods used in the past month and were asked, "If you could choose any method of contraception or birth control to prevent pregnancy, what would be your ideal choice?" and selected a single "ideal" method. If applicable, participants were additionally asked, "Why aren't you currently using this method of contraception?" We used adjusted logistic regression to identify patient-, provider-, and system-level factors associated with ideal-current method match. We qualitatively analyzed open-ended responses about reasons for ideal method nonuse. RESULTS: Overall, 58% were currently using their ideal method; match was greatest among women selecting an IUD as ideal (73%). Non-White race/ethnicity (adjusted odds ratio, 0.68; 95% confidence interval, 0.52-0.89) and mental illness (adjusted odds ratio, 0.69; 95% confidence interval, 0.52-0.92) were negatively associated with ideal-current match in adjusted analyses; the presence of a gynecologist at the primary care site was associated with an increased odds of match (adjusted odds ratio, 1.35; 95% confidence interval, 1.03-1.75). Modifiable barriers to ideal method use were cited by 23% of women, including access issues, cost concerns, and provider-level barriers; 79% of responses included nonmodifiable reasons for mismatch including relationship factors and pregnancy plans incongruent with ideal method use, suggesting limitations of our measure based on differential interpretation of the word "ideal." CONCLUSIONS: Many women veterans are not currently using the contraceptive method they consider ideal. Results emphasize the complexity of contraceptive method selection and of measuring contraceptive preference matching.

Perceived Barriers and Facilitators to Contraceptive Use Among Women Veterans Accessing the Veterans Affairs Healthcare System.

BACKGROUND: Although many studies evaluate factors influencing contraceptive use, little is known about barriers and facilitators that may be specific to or prevalent among women veterans using the Veterans Affairs Healthcare System (VA). DESIGN: Semistructured telephone interviews with a national sample of 189 women veterans at risk for unintended pregnancy who receive care in the VA were used to explore barriers and facilitators to contraceptive use as well as elicit suggestions for improving VA contraceptive care. The sample consisted primarily of women with risk factors for adverse reproductive health outcomes, including belonging to ethnic/racial minority groups, having a medical or mental health condition(s), and/or reporting a history of military sexual trauma. Transcript narratives were analyzed using content analysis and the constant comparison method. RESULTS: Five distinct themes emerged as barriers or facilitators to contraceptive use depending on participants' VA facility and provider, and women offered concrete suggestions to address each barrier. Most participants (56%) noted poor efficiency as a barrier; others (39%) felt hindered by limited contraceptive counseling and patient education. Approximately one-third (34%) noted that low patient awareness of services impeded care and another one-third (32%) stressed poor interaction with providers as a barrier. Finally, 31% noted feeling ostracized at VA, and emphasized fostering a woman-friendly environment to remove discomfort associated with seeking contraceptive care. CONCLUSIONS: These findings suggest that, despite widespread access to low-cost contraception, many women veterans experience barriers to accessing high-quality contraceptive care. These barriers are system and provider specific and warrant further internal evaluation.

Associations Between Perceived Susceptibility to Pregnancy and Contraceptive Use in a National Sample of Women Veterans.

CONTEXT: Women may be at risk for unintended pregnancy if they forgo contraception or use ineffective methods because they erroneously believe they are unlikely to conceive. However, the relationship between perceived susceptibility to pregnancy and contraceptive use is not fully understood. METHODS: Data collected in 2014-2016 for the Examining Contraceptive Use and Unmet Needs study were used to examine perceived susceptibility to pregnancy among 969 women veterans aged 20-45 who were at risk for unintended pregnancy and received primary care through the U.S. Veterans Affairs Healthcare System. Multivariable logistic regression was used to identify associations between perceived susceptibility to pregnancy (perceived likelihood during one year of unprotected intercourse) and use of any contraceptive at last sex. Multinomial regression models were used to examine method effectiveness among women who used a contraceptive at last sex. RESULTS: Forty percent of women perceived their susceptibility to pregnancy to be low. Compared with women with high perceived susceptibility to pregnancy, those with low perceived susceptibility were less likely to have used any contraceptive at last sex (86% vs. 96%; adjusted odds ratio, 0.2). Among contraceptive users, women with low perceived susceptibility were less likely than those with high perceived susceptibility to have used a highly effective method (26% vs. 34%; adjusted relative risk ratio, 0.6) or moderately effective method (34% vs. 39%; 0.6) at last sex. CONCLUSIONS: Identifying and addressing fertility misperceptions among women with low perceived susceptibility to pregnancy could help promote informed decision making about contraception and reduce the risk of unintended pregnancy.

Continuous access to snacks from weaning onwards in female rats causes weight gain, insulin insensitivity, and sustained leptin resistance in adulthood.

A large part of the daily intake of children in the U.S. consists of snacks, with the average child consuming three snacks per day. Despite this, little research has been conducted to determine the metabolic and behavioral effects of snacking. Using a developing female rat model, our studies aimed to determine the effects of snacking during development before the protective effects of estrogen on weight gain would be relevant. Additionally, to determine if snack composition is important, we created one healthy and one unhealthy snacking group provided with chow and three snacks each in addition to a chow-only group. We found that both snacking groups experienced increased weight gain, elevated abdominal fat pad mass, prolonged leptin resistance into adulthood, and insulin insensitivity that was not observed in their non-snacking counterparts. These physiological differences were measured despite both snacking groups having a similar caloric intake as the chow-only group throughout the study. In addition to physiological changes, both snacking groups showed a preference for snacks over chow and ate more often during the inactive light phase than typical for rats, with the unhealthy snacking group presenting this behavioral change earlier than the healthy snacking group. Our results suggest that constant access to palatable snacks, which is often the case for children in western countries, alters feeding behaviors in relation to food choice and time of day when eating occurs. Snacking during development seemed to promote signs of metabolic syndrome in adulthood even when excess caloric intake was not observed. Our work further suggests that development is a vulnerable time for palatable snack presentation when prepubertal females lack the protective effects of estrogen and exhibit reduced leptin feedback on food intake. Thus snacking from weaning onward could be a contributor to the current childhood obesity crisis.

Associations between Pregnancy Intention, Attitudes, and Contraceptive Use among Women Veterans in the ECUUN Study.

BACKGROUND: Although pregnancy intention is strongly associated with contraceptive use, little is known about the interaction between pregnancy intention and attitude, or how they jointly affect contraceptive use. METHODS: Cross-sectional data from a national survey of women veterans who receive care within the Veterans Affairs Healthcare System were used to examine relationships among pregnancy intention (in next year, in >1 year, never, not sure), attitude toward hypothetical pregnancy (worst thing, neutral, best thing), and contraceptive use among women at risk for unintended pregnancy. Bivariate and multivariable analyses assessed associations between pregnancy intention and attitude, both separately and jointly, with contraceptive use. Multinomial regression assessed the relationship of intention and attitude with contraceptive method effectiveness. RESULTS: Among 858 women at risk of unintended pregnancy, bivariate analysis demonstrated that pregnancy intention and attitude were associated, but not perfectly aligned. In logistic regression models including both variables, intention of never versus in next year (adjusted odds ratio [aOR], 2.78; 95% confidence interval [CI], 1.34-5.75) and attitude of worst thing versus best thing (aOR, 2.86; 95% CI, 1.42-5.74) were each positively associated with contraception use. Among women using contraception, intention of never (aOR, 3.17; 95% CI, 1.33-7.59) and attitude of worst thing (OR, 2.09; 95% CI, 1.05-4.17) were associated with use of highly effective (e.g., intrauterine devices and implants) versus least effective (e.g., barrier) methods. CONCLUSIONS: These findings support prior research suggesting that pregnancy intention alone does not fully explain contraceptive behaviors and imply that attitude toward pregnancy plays an important role in shaping contraceptive use independent of pregnancy intentions.

"Without bodily autonomy we are not free": exploring women's concerns about future access to contraception following the 2016 US presidential election.

OBJECTIVE: Following the 2016US presidential election, social media posts and news stories amplified concerns about the potential for reduced access to contraception under the incoming administration and urged women to seek long-acting reversible contraception. We aimed to describe women's concerns about future access to contraception, in their own words. STUDY DESIGN: A social-media-based, anonymous online survey assessing thoughts and concerns about future access to contraception was distributed to reproductive-aged US women for 1 week in mid-January 2017. Participants who were concerned about future access to contraception could share their thoughts and feelings in an open-ended comments box. We qualitatively analyzed 449 written responses for content and themes, with the goal of characterizing key concerns. RESULTS: Women who provided written comments had a mean age of 28years; 85% were white, 88% had at least a college degree, and 93% identified as Democratic or Democratic-leaning. Women were highly concerned about future affordability of contraceptive methods due to potential loss of insurance, reduced insurance coverage for contraceptive methods and reduced access to low-cost care at Planned Parenthood. Many also worried about increased restrictions on abortion. Participants' concerns regarding access to contraception and abortion centered around themes of reproductive and bodily autonomy, which women described as fundamental rights. CONCLUSIONS: Women in this study expressed considerable fear and uncertainty regarding their future access to contraception and abortion following the 2016US presidential election. The potential for restricted access to affordable contraception and abortion was viewed as an unacceptable limitation on bodily autonomy. IMPLICATIONS: As the future of US health care policy is debated, many women are concerned about the impact of policy changes on their ability to access affordable contraception and abortion, which many view as essential to the preservation of bodily and reproductive autonomy.