Participation in clinical trials improves outcomes in women's health: a systematic review and meta-analysis.

Abstract

Previous reviews examining the effect of participation in trials on outcomes have not consistently shown benefit. Obstetrics and gynaecology is a unique disease area posing challenges for both researchers and patients. To determine whether participation in randomised controlled trials (RCTs), compared with non-participation, has a beneficial effect on women's health. Medline, Embase, the Cochrane Library, and PsycInfo were searched up to December 2015. We selected studies that reported the same clinical outcomes for participants in a women's health RCT and a comparable non-participant cohort. Data were extracted on quality, characteristics and study results. Outcomes were compared using logistic regression. There were 21 relevant studies (20160 women, 4759 outcome events). Trial participants, compared with non-participants, had 25% better odds of improved outcomes on average (OR 0.75; 95% CI 0.64-0.87; I2 =64.3%). The beneficial effect of participating in a trial was larger in comparisons where: RCTs were of high quality (OR 0.62; 95% CI 0.50-0.76) versus low (OR 0.92; 95% CI 0.74-1.16); and RCT intervention was not available to non-participants (OR 0.57; 95% CI 0.47-0.69) versus when it was (OR 1.13; 95% CI 0.89-1.44). The effect of trial participation was not influenced by effect size within the RCT (P=0.48), whether funding was received or not (P=0.13), whether non-participants received any treatment or not (P=0.49), and the quality of the comparison of RCT participants with non-participants (P=0.88). Women participating in RCTs on average experienced better outcomes compared with those outside trials. Participants in obstetric and gynaecology RCTs experience better outcomes compared with non-participants.