Enrollment and Retention of Men and Women in Health Services Research and Development Trials

Abstract

Introduction: Sex-and gender-specific science is essential to inform patient-centered, evidence-based care. Developing such evidence requires adequate inclusion of both women and men in trials. We sought to describe study participation of women and men in Department of Veterans Affairs Health Services Research and Development trials. Methods: We identified recent health services research trials from one Health Services Research and Development Center of Innovation and compared the participation of women and men from trial recruitment to study completion. We also calculated the participation to prevalence ratio (PPR) by sex for each trial. Results: We included eight trials that started recruitment between 2011 and 2014. Only one study purposefully attempted to boost the recruitment of women. Overall, the PPR for women ranged from 0.2 to 4.5, with seven studies having a PPR of greater than 1, indicating that women participated in these trials at proportions greater than their prevalence in the disease population within the Department of Veterans Affairs. The PPR for men ranged from 0.8 to 1.1. Retention was best with those studies that used administrative data for final outcomes assessment. No studies provided results stratified by sex or conducted analyses to explore treatment effect by sex. Conclusions: At a single site, women participated in Health Services Research and Development trials at similar or greater rates to men without cross-study efforts to enrich the recruitment or retention of women. Adding strategic recruitment approaches could further boost the proportion of women in Department of Veterans Affairs trials and enable adequately powered sex-based analyses. Published by Elsevier Inc. on behalf of Jacobs Institute of Women's Health. Sex-and gender-based differences in the pathophysiology, quality of care, and patient experiences of disease require sexand gender-specific science to inform the provision of patientcentered, evidence-based care. For example, when compared with men, women with coronary artery disease are less likely to take statins and antiplatelet medications (Johansen, Hefner, & Foraker, 2015), and respond differently to pharmacologic interventions for pain (Bartley & Fillingim, 2013). Acquiring the evidence needed to optimize patient-centered care for women Supported by the Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) (CIN 13-410

Accelerating the Growth of Evidence-Based Care for Women and Men Veterans

“…The included works stem from not only trials (Danan, Sherman, et al, 2019a) and cohort studies (Dursa et al, 2019;Harrington et al, 2019;Naylor et al, 2019;Brown et al, 2019), but also clinical program evaluations (Kumpula et al, 2019), VA patient experience surveys (Breland et al, 2019), and research process metrics (Goldstein et al, 2019). Multiple VA research entities are represented in this collection, including the Cooperative Studies Program (e.g., Harrington et al, 2019;Brown et al, 2019), the VA Evidence Synthesis Program (Danan, Ullman, et al, 2019b), Health Services Research & Development (Combellick et al, 2019;Danan, Sherman, et al, 2019a;Goldstein et al, 2019), and Mental Illness Research Education Clinical Centers of Excellence (Naylor et al, 2019). Bovin et al exemplify the usefulness of combining the VA's array of data sources, including electronic medical record and research survey data, to produce clinically important findings related to MST screening.…”

“…Although the work in this supplement suggests that women veterans are likely to participate in research studies when given the chance (Goldstein et al, 2019;Harrington et al, 2019), difficulties achieving sufficient participation by women to support appropriate analyses remain. Moreover, as discussed in the commentary by Klap and Humphreys (2019), conducting research with consideration for subgroup differences requires thoughtful and appropriate use of statistical approaches.…”

“…The authors include key recommendations for improving the reporting of sex and gender findings to guide future investigations. Second, Goldstein et al (2019) examined recently conducted behavioral trials in one VA Health Services Research and Development Center of Innovation to describe participation by gender. Although only one of eight included trials made special efforts to include women, the majority of studies included women at or above the proportion affected by the target condition.…”

Socio-Economic Factors of Empowerment in Developing Countries

“…Women empowerment has been defined as women access to get education, healthy economic and political access (Sweeney, Wilson, & Brown, 2019). Women are regarded as a best form of human capital and are regarded as important assets for a society and indispensable for the process of development (Goldstein et al, 2019). Research indicates that investments in women"s employment, health, and education, are correlated with a range of positive outcomes.…”

Integrating the Influence of Sex and Gender in Research: Keeping Women Veterans in Focus

“…Therefore, efforts to reanalyze data that were not previously disaggregated by sex/ gender to address the gaps in the health of women today could expedite advances (see Brown et al, 2019;Bovin et al, 2019). Researchers can also conduct systematic reviews (see Duan-Porter et al, 2016;Goldstein et al, 2019) or meta-analyses by merging existing findings to answer questions that might be difficult to study because of limitations in the number of women available for any one study.…”