Dataset Information

Representation of women in heart failure clinical trials: Barriers to enrollment and strategies to close the gap.

ABSTRACT: Heart failure is a significant public health burden that differentially impacts women. Important sex- and gender-based differences in HF risk factors, presentation, and treatment exist, and the generation of high-quality evidence is critical to elucidate these differences. Despite the remarkable growth of the heart failure clinical research enterprise over the last four decades, women remain underrepresented in heart failure clinical trials relative to the population prevalence of heart failure in women. This disparity has resulted in significant knowledge gaps regarding the optimal care of women with heart failure. In this review, we summarize the existing literature regarding the participation of women in heart failure clinical trials. Additionally, we explain the evidence surrounding sex- and gender-specific barriers to enrollment in heart failure clinical trials and describe interventions that should be implemented throughout the clinical trial lifespan to achieve sex and gender parity.

SUBMITTER: Reza N

PROVIDER: S-EPMC8890694 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Representation of women in heart failure clinical trials: Barriers to enrollment and strategies to close the gap.

Reza Nosheen N Gruen Jadry J Bozkurt Biykem B

American heart journal plus : cardiology research and practice 20220130

Heart failure is a significant public health burden that differentially impacts women. Important sex- and gender-based differences in HF risk factors, presentation, and treatment exist, and the generation of high-quality evidence is critical to elucidate these differences. Despite the remarkable growth of the heart failure clinical research enterprise over the last four decades, women remain underrepresented in heart failure clinical trials relative to the population prevalence of heart failure ...[more]

PMID: 35243454

Similar Datasets

Project description:BackgroundEquitable sex- and gender-based representation in clinical trials is an essential step to ensuring evidence-based care for women. While multi-institutional actions have led to significant improvements in the inclusion of women in trials, inequity persists in areas like sex-neutral cancers and cardiovascular disease. We sought to identify strategies described or evaluated to boost the inclusion of women in clinical trials.MethodsWe used evidence mapping methodology to examine the breadth of relevant literature. We developed an a priori protocol and followed reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis where applicable. We searched MEDLINE® (via PubMed) and EMBASE (via Elsevier) databases from inception through April 4, 2023, and used standardized procedures incorporating duplication and data verification. We included articles that described strategies to improve the recruitment and retention of women in clinical trials.ResultsWe identified 122 articles describing recruitment and retention strategies for 136 trials (377,595 women). Only one article distinguished between the sex and gender identity of participants, and none defined their use of the terms such as "women" or "female". The majority of articles (95%) described recruitment for only women, and 64% were conducted in the USA. Ninety-two articles (75%) described strategies in the context of sex-specific conditions (e.g., gynecologic diagnosis). The majority of included articles evaluated a behavioral intervention (52%), with 23% evaluating pharmacologic interventions and 4% invasive interventions. The most common trial phase for reported strategies was during outreach to potential participants (116 articles), followed by intervention delivery (76), enrollment (40), outcomes assessment (21), analysis and interpretation (3), and dissemination (4). We describe specific types of strategies within each of these phases.ConclusionsMost of the existing literature describing strategies to improve the inclusion of women draws from trials for sex-specific conditions and is largely related to outreach to potential participants. There is little information about how and if studies have attempted to proportionally increase the inclusion of women in trials with both men and women or those focused on invasive and pharmacologic interventions. Future work in this area should focus on how to increase the participation of women in mixed-sex studies and on those areas with remaining inequities in trial participation.

Project description:BackgroundVaccine clinical trials should strive to recruit a racially, socioeconomically, and ethnically diverse range of participants to ensure appropriate representation that matches population characteristics. Yet, full inclusion in research is often limited.MethodsA single-center retrospective study was conducted of adults enrolled at Brigham and Women's Hospital (Boston, MA) between July 2020 and December 2021. Demographic characteristics, including age, race, ethnicity, ZIP code, and sex assigned at birth, were analyzed from both HIV and COVID-19 vaccine trials during the study period, acknowledging the limitations to representation under these parameters. We compared the educational attainment of vaccine trial participants to residents of the Massachusetts metropolitan area, geocoded participants' addresses to their census block group, and linked them to reported median household income levels from publicly available data for 2020. Frequency and quartile analyses were carried out, and spatial analyses were performed using ArcGIS Online web-based mapping software (Esri).ResultsA total of 1030 participants from four COVID-19 vaccine trials (n = 916 participants) and six HIV vaccine trials (n = 114 participants) were included in the analysis. The median age was 49 years (IQR 33-63) and 28 years (IQR 24-34) for the COVID-19 and HIV vaccine trials, respectively. Participants identifying as White were the majority group represented for both the COVID-19 (n = 598, 65.3%) and HIV vaccine trials (n = 83, 72.8%). Fewer than 25% of participants identified as Hispanic or Latin. Based on ZIP code of residence, the median household income for COVID-19 vaccine clinical trial participants (n = 846) was 102,088 USD (IQR = 81,442-126,094). For HIV vaccine clinical trial participants (n = 109), the median household income was 101,266 USD (IQR 75,052-108,832).ConclusionWe described the characteristics of participants enrolled for HIV and COVID-19 vaccine trials at a single center and found similitude in geographical distribution, median incomes, and proportion of underrepresented individuals between the two types of vaccine candidate trials. Further outreach efforts are needed to ensure the inclusion of individuals from lower educational and socioeconomic brackets. In addition, continued and sustained efforts are necessary to ensure inclusion of individuals from diverse racial and ethnic backgrounds.

Dataset Information

Representation of women in heart failure clinical trials: Barriers to enrollment and strategies to close the gap.

Publications

Representation of women in heart failure clinical trials: Barriers to enrollment and strategies to close the gap.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets