Background:Trial steering committees (TSCs) steer the conduct of randomized controlled trials (RCTs). We examined the gender composition of TSCs in impactful heart failure RCTs and explored whether trial leadership by a woman was independently associated with the inclusion of women in TSCs.Methods:We systematically searched MEDLINE, EMBASE, and CINAHL for heart failure RCTs published in journals with impact factor ≥10 between January 2000 and May 2019. We used the Jonckheere-Terpstra test to assess temporal trends and multivariable logistic regression to explore trial characteristics associated with TSC inclusion of women.Results:Of 403 RCTs that met inclusion criteria, 127 (31.5%) reported having a TSC but 20 of these (15.7%) did not identify members. Among 107 TSCs that listed members, 56 (52.3%) included women and 6 of these (10.7%) restricted women members to the RCT leaders. Of 1213 TSC members, 11.1% (95% CI, 9.4%–13.0%) were women, with no change in temporal trends (P=0.55). Women had greater odds of TSC inclusion in RCTs led by women (adjusted odds ratio, 2.48 [95% CI, 1.05–8.72], P=0.042); this association was nonsignificant when analysis excluded TSCs that restricted women to the RCT leaders (adjusted odds ratio 1.46 [95% CI, 0.43–4.91], P=0.36).Conclusions:Women were included in 52.3% of TSCs and represented 11.1% of TSC members in 107 heart failure RCTs, with no change in trends since 2000. RCTs led by women had higher adjusted odds of including women in TSCs, partly due to the self-inclusion of RCT leaders in TSCs.

中文翻译：

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与女性纳入心力衰竭试验指导委员会相关的时间趋势和临床试验特征：系统评价

背景：试验指导委员会 (TSC) 指导随机对照试验 (RCT) 的进行。我们检查了有影响的心力衰竭 RCT 中 TSC 的性别构成，并探讨了女性领导试验是否与 TSC 中女性纳入独立相关。 2000 年 1 月至 2019 年 5 月期间影响因子≥10。我们使用 Jonckheere-Terpstra 检验评估时间趋势和多变量逻辑回归来探索与 TSC 纳入女性相关的试验特征。结果：在 403 项符合纳入标准的 RCT 中，127 (31.5 %) 报告有 TSC，但其中 20 个 (15.7%) 没有确定成员。在列出成员的 107 个 TSC 中，56 个 (52.3%) 包括女性，其中 6 个 (10. 7%) 将女性成员限制为 RCT 领导人。在 1213 名 TSC 成员中，11.1%（95% CI，9.4%–13.0%）是女性，时间趋势没有变化（P = 0.55）。女性在女性主导的 RCT 中纳入 TSC 的几率更高（调整后的优势比，2.48 [95% CI，1.05–8.72]，P = 0.042）；当分析排除将女性限制为 RCT 领导者的 TSC 时，这种关联不显着（调整后的比值比为 1.46 [95% CI，0.43–4.91]，P = 0.36）。结论：女性被包括在 52.3% 的 TSC 中，代表 11.1% 107 项心力衰竭 RCT 中的 TSC 成员，自 2000 年以来趋势没有变化。由女性领导的 RCT 将女性纳入 TSC 的调整后几率更高，部分原因是 RCT 领导者自行纳入 TSC。