Publication date: Available online 26 November 2017
Source:Journal of Clinical Epidemiology
Author(s): Rohit P. Ojha, Bradford E. Jackson, Yan Lu, Mandy Burton, Somer E. Blair, Brooke MacDonald, Tzu-Chun Chu, Kari Teigen, Melissa Acosta
ObjectiveWe aimed to systematically review published literature to assess study-level sources of heterogeneity in participation and retention for randomized controlled trials (RCTs) conducted exclusively at safety-net institutions, which are primary sources of care for underserved populations.Study design and settingWe searched PubMed/Medline and the Cochrane Central Register of Controlled Trials to identify phase III RCTs of any topic conducted exclusively at safety-net institutions in the United States through October 15, 2016. We used random-effects models with Freeman-Tukey arcsine transformations to estimate stratum-specific summary estimates for participation and loss to follow-up proportions.ResultsWe identified 53 eligible RCTs. Participation ranged from 6.0% to 100% and loss to follow-up ranged from 0% to 70% for individual RCTs. Cancer-related RCTs had the highest participation (90%, 95% confidence limits [CL]: 76%, 99%) and lowest loss to follow-up (2.0%, 95% CL: 0%, 4.0%). RCTs that offered financial incentives did not have higher participation or lower loss to follow-up compared with RCTs without financial incentives.ConclusionsOur results suggest that underserved populations can have high participation and retention in RCTs at safety-net institutions, which adds to the growing body of evidence that refutes the notion of underserved populations being unwilling to participate in RCTs.
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