Masking in Pragmatic Trials: Who, What, and When to Blind
Jennifer B. Christian, PharmD, MPH, PhD, FISPE, Emily S. Brouwer, MPH, PharmD, PhD, Cynthia J. Girman, DrPH, FISPE, Dimitri Bennett, MD, MPH, FISPE, FACE, Kourtney J. Davis, PhD, MSPH, and Nancy A. Dreyer, PhD, MPH, FISPE
Sep 24, 2019
Whether pRCTs should be masked if intended for regulatory or other purposes has recently been questioned. The literature on pRCTs, while extensive, does not address how much actual benefit is gained from masking outcomes and how masking may affect the “real world” nature of a study. Here, we propose an approach to evaluate sources of bias, describe stakeholders in the conduct of pRCTs who are most likely affected, and offer a framework for considering how masking may be implemented effectively while maintaining generalizability.
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