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.

Use of Electronic Patient Messaging by Pregnant Patients Receiving Prenatal Care at an Academic Health System: Retrospective Cohort Study.

Background: The COVID-19 pandemic accelerated telemedicine and mobile app use, potentially changing our historic model of maternity care. MyChart is a widely adopted mobile app used in health care settings specifically for its role in facilitating communication between health care providers and patients with its messaging function in a secure patient portal. However, previous studies analyzing portal use in obstetric populations have demonstrated significant sociodemographic disparities in portal enrollment and messaging, specifically showing that patients who have a low income and are non-Hispanic Black, Hispanic, and uninsured are less likely to use patient portals. Objective: The study aimed to estimate changes in patient portal use and intensity in prenatal care before and during the pandemic period and to identify sociodemographic and clinical disparities that continued during the pandemic. Methods: This retrospective cohort study used electronic medical record (EMR) and administrative data from our health system's Enterprise Data Warehouse. Records were obtained for the first pregnancy episode of all patients who received antenatal care at 8 academically affiliated practices and delivered at a large urban academic medical center from January 1, 2018, to July 22, 2021, in Chicago, Illinois. All patients were aged 18 years or older and attended ≥3 clinical encounters during pregnancy at the practices that used the EMR portal. Patients were categorized by the number of secure messages sent during pregnancy as nonusers or as infrequent (≤5 messages), moderate (6-14 messages), or frequent (≥15 messages) users. Monthly portal use and intensity rates were computed over 43 months from 2018 to 2021 before, during, and after the COVID-19 pandemic shutdown. A logistic regression model was estimated to identify patient sociodemographic and clinical subgroups with the highest portal nonuse. Results: Among 12,380 patients, 2681 (21.7%) never used the portal, and 2680 (21.6%), 3754 (30.3%), and 3265 (26.4%) were infrequent, moderate, and frequent users, respectively. Portal use and intensity increased significantly over the study period, particularly after the pandemic. The number of nonusing patients decreased between 2018 and 2021, from 996 of 3522 (28.3%) in 2018 to only 227 of 1743 (13%) in the first 7 months of 2021. Conversely, the number of patients with 15 or more messages doubled, from 642 of 3522 (18.2%) in 2018 to 654 of 1743 (37.5%) in 2021. The youngest patients, non-Hispanic Black and Hispanic patients, and, particularly, non-English-speaking patients had significantly higher odds of continued nonuse. Patients with preexisting comorbidities, hypertensive disorders of pregnancy, diabetes, and a history of mental health conditions were all significantly associated with higher portal use and intensity. Conclusions: Reducing disparities in messaging use will require outreach and assistance to low-use patient groups, including education addressing health literacy and encouraging appropriate and effective use of messaging.

Interventions to Reduce Inpatient and Discharge Opioid Prescribing for Postpartum Patients: A Systematic Review.

INTRODUCTION: As deaths related to opioids continue to rise, reducing opioid use for postpartum pain management is an important priority. Thus, we conducted a systematic review of postpartum interventions aimed at reducing opioid use following birth. METHODS: From database inception through September 1, 2021, we conducted a systematic search in Embase, MEDLINE, Cochrane Library, and Scopus including the following Medical Subject Heading (MeSH) terms: postpartum, pain management, opioid prescribing. Studies published in English, restricted to the United States, and evaluating interventions initiated following birth with outcomes including an assessment of change in opioid prescribing or use during the postpartum period (<8 weeks postpartum) were included. Authors independently screened abstracts and full articles for inclusion, extracted data, and assessed study quality using the Grading of Recommendations, Assessment, Development, and Evaluation tool and risk of bias using the Institutes of Health Quality Assessment Tools. RESULTS: A total of 24 studies met inclusion criteria. Sixteen studies evaluated interventions aimed at reducing postpartum opioid use during the inpatient hospitalization, and 10 studies evaluated interventions aimed at reducing opioid prescribing at postpartum discharge. Inpatient interventions included changes to standard order sets and protocols for the management of pain after cesarean birth. Such interventions resulted in significant decreases in inpatient postpartum opioid use in all but one study. Additional inpatient interventions, including use of lidocaine patches, postoperative abdominal binder, valdecoxib, and acupuncture were not found to be effective in reducing postpartum opioid use during inpatient hospitalization. Interventions targeting the postpartum period included individualized prescribing and state legislative changes limiting the duration of opioid prescribing for acute pain both resulted in decreased opioid prescribing or opioid use. DISCUSSION: A variety of interventions aimed at reducing opioid use following birth have shown efficacy. Although it is not known if any single intervention is most effective, these data suggest that implementation of any number of interventions may be advantageous in reducing postpartum opioid use.

Natural Cycle Frozen Embryo Transfer: Evaluating Optimal Protocols for Preparation and Timing.

Background: While natural cycle frozen embryo transfer (NC-FET) is becoming increasingly common, significant practice variation exists in the use of ovulation induction medications, administration of ovulation trigger, and timing of embryo transfer without consensus as to the optimal protocol. Aims: The objective of this study is to evaluate the association of key aspects of the NC-FET protocol with implantation, pregnancy and live birth. Settings and Design: This was a retrospective cohort study of blastocyst stage NC-FET cycles from October 2019 to July 2021 at a single academic fertility centre. Materials and Methods: Protocols varied between cycles across three key parameters which were evaluated as primary predictors of cycle outcomes: (1) use of letrozole for mild ovarian stimulation/ovulation induction, (2) administration of exogenous ovulation trigger versus spontaneous luteinising hormone surge and (3) transfer timing based on ovulation trigger versus sequential progesterone monitoring. Primary outcomes included implantation rate, clinical pregnancy and ongoing pregnancy. Statistical Analysis Used: Generalised estimating equations were fitted to obtain adjusted odds ratios or rate ratios as appropriate with 95% confidence intervals for each outcome across the three primary predictors. Results: A total of 183 cycles from 170 unique patients were eligible for inclusion. The average implantation rate was 0.58, resulting in an overall clinical pregnancy and ongoing pregnancy rate of 59.0% and 51.4%, respectively. After adjusting for age at embryo freeze and history of a failed embryo transfer, there were no significant associations between any predictor and implantation rate, clinical pregnancy, ongoing pregnancy, or live birth. Conclusion: In NC-FET, a variety of preparation and timing protocols may lead to comparable cycle outcomes, potentially allowing for flexibility on the basis of patient and physician preference. These findings warrant validation in a larger, randomised trial.

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.

Housing instability and adverse perinatal outcomes: a systematic review.

OBJECTIVE: Our objective was to conduct a systematic review of the published literature on housing instability during pregnancy and adverse pregnancy outcomes and perinatal healthcare utilization. DATA SOURCES: We performed a systematic search in November 2020 using Embase, MEDLINE, Cochrane Library, and Scopus using terms related to housing instability during pregnancy, adverse pregnancy outcomes, and perinatal healthcare utilization. The search was limited to the United States. STUDY ELIGIBILITY CRITERIA: Studies examining housing instability (including homelessness) during pregnancy and adverse pregnancy outcomes (including preterm birth, low birthweight neonates, and maternal morbidity) and perinatal healthcare utilization were included. METHODS: Two authors screened abstracts and full-length articles for inclusion. The final cohort consisted of 14 studies. Two authors independently extracted data from each article and assessed the study quality using the Grading of Recommendations, Assessment, Development, and Evaluation tool. Risk of bias was assessed using the National Institutes of Health Study Quality Assessment Tools. RESULTS: All included studies were observational, including retrospective cohort (n=10, 71.4%), cross-sectional observational (n=3, 21.4%), or prospective cohort studies (n=1, 7.1%). There was significant heterogeneity in the definitions of housing instability and homelessness. Most of the studies only examined homelessness (n=9, 64.3%) and not lesser degrees of housing instability. Housing instability and homelessness during pregnancy were significantly associated with preterm birth, low birthweight neonates, neonatal intensive care unit admission, and delivery complications. Among studies examining perinatal healthcare utilization, housing instability was associated with inadequate prenatal care and increased hospital utilization. All studies exhibited moderate, low, or very low study quality and fair or poor internal validity. CONCLUSION: Although data on housing instability during pregnancy are limited by the lack of a standardized definition, a consistent relationship between housing instability and adverse pregnancy outcomes has been suggested by this systematic review. The evaluation and development of a standardized definition and measurement of housing instability among pregnant individuals is warranted to address future interventions targeted to housing instability during pregnancy.