Temporal Trends and Clinical Trial Characteristics Associated With the Inclusion of Women in Heart Failure Trial Steering Committees: A Systematic Review

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.

Rationale and design of the EPCHF trial: the early palliative care in heart failure trial (EPCHF)

The progressive nature of heart failure (HF) coupled with high mortality and poor quality-of-life (QoL) mandates greater attention to palliative care (PC) as a routine component of HF management. Limited evidence exists from randomized controlled trials supporting the use of interdisciplinary palliative care in the progressive course of HF. The early palliative care in heart failure trial (EPCHF) is a prospective, controlled, nonblinded, multicenter study of an interdisciplinary palliative care intervention in 200 patients with symptomatic HF characterized by NYHA ≥ 2. The 12-month EPCHF intervention includes monthly consultations by a palliative care team focusing on physical and psychosocial symptom relief, attention to spiritual concerns and advance care planning. The primary endpoint is evaluated by health-related QoL questionnaires after 12 months of treatment. First the functional assessment of chronic illness therapy palliative care (FACIT-Pal) score evaluating QoL living with a chronic disease and second the Kansas City cardiomyopathy questionnaire (KCCQ) measuring QoL living with heart failure will be determined. Secondary endpoints are changes in anxiety/depression (HADS), symptom burden score (MIDOS), spiritual well-being functional assessment of chronic illness therapy spiritual well-being scale (FACIT-Sp), medical resource and cost assessment. EPCHF will help evaluate the efficacy and cost-effectiveness of palliative care in symptomatic HF using a patient-centered outcome as well as clinical and economic endpoints. EPCHF is funded by the Bundesministerium für Bildung und Forschung (BMBF, 01GY17).