Evidence Map: Reporting of Results by Sex or Gender in Randomized, Controlled Trials with Women Veteran Participants (2008 to 2018)

Abstract

Background: Higher participation of women in randomized, controlled trials (RCTs) has not led to significantly improved reporting of sex-stratified results. A recent evidence map of research on women veterans revealed that many studies did not report results by sex or gender. This study's objectives were to compare characteristics of RCTs with women veteran participants that did or did not report results by sex or gender and to assess how sex and gender are addressed in research with women veterans. Methods: We extended the prior evidence map with a systematic search for RCTs with women veterans, published between 2008 and 2018. We compared the characteristics of RCTs that reported results by sex or gender with those of RCTs that did not, and reviewed methodology and reporting of sex/gender analyses. Results: In addition to 11 studies from the prior evidence map, we assessed 1,820 abstracts for relevance and ultimately included 45 unique RCTs. Five trials included only women and 40 included both men and women (median, 14.3% women). Ten studies reported results by sex or gender. These trials were larger (median study size of n ¼ 343.5 vs. n ¼ 125.5) and included a higher median proportion of women participants (16.8% vs. 11.2%) than studies without sex/ gender results. Ten of 11 trials that tested pharmacologic or device interventions did not report results by sex or gender. Conclusions: Reporting of results by sex or gender remains low in veteran research, but may improve with larger studies and increased recruitment of women veterans into trials. Trials of pharmacologic or device interventions may be targets for future reporting requirements. Standardization could improve attention to sex and gender in methodology and reporting.

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.…”

“…The final area of work represented in this supplement focuses on methods for approaching the field of sex and gender differences in veteran health. First, Danan, Ullman, et al (2019b) built on a recent systematic review that mapped the evidence surrounding women veterans' health. This additional work sought to compare randomized controlled trials that did and did not report sex/gender differences.…”

Gender differences in PTSD severity and pain outcomes: baseline results from the LAMP trial

“…This mechanism has been well studied in predominantly male Veteran (30) and civilian (31) samples, which may obscure important differences in the manifestation and severity. While the findings of studies using Veteran samples support the central tenant of the mutual maintenance model, namely the mutually reinforcing and exacerbating influence of PTSD on chronic pain outcomes, very few have had adequate numbers of men and women Veterans to identify differential effects by gender (32). The current study assesses whether gender differences exist in association between PTSD symptoms and pain outcomes in a comparative sample of men and women Veterans.…”

Trauma Center Trauma-Sensitive Yoga Versus Cognitive Processing Therapy for Women Veterans With PTSD Who Experienced Military Sexual Trauma: A Feasibility Study

“…On the other hand, participants were far more willing to undergo data collection, including blood draws and DES, than anticipated. We theorize that this reflects a combination of veterans' generally higher willingness to participate in research studies than civilians, women veterans appreciating a study designed specifically for them as they are underrepresented in VA studies, as well as the benefits of research staff experienced in interpersonal trauma-related research and able to establish trust and rapport with participants (Campbell et al, 2007;Danan et al, 2019) Striking a balance between thorough data collection and participant burden in this study was challenging. The planned aims for the full-scale RCT included a comprehensive evaluation of PTSD symptoms and commonly co-occurring symptoms of depression, chronic pain, and sleep disturbance.…”