All Times EDT
Keywords: pragmatic trials, electronic health record, participant selection
Clinical trials typically require substantial infrastructure for participant recruitment, engagement, enrollment, management, retention, and follow-up. At each step in the process, there is a risk of loss to follow-up, which hinders statistical power because of reduced sample size, as well as generalizability because of selection pressures. One goal of pragmatic clinical trials is to mitigate these concerns by making trial participation less burdensome; this, in turn, should lead to both higher retention and a greater level of representativeness. Digital health platforms are one feature of pragmatic clinical trials that offer great promise in achieving these goals. When carefully constructed and deployed, such digital research platforms can reduce barriers to participant recruitment and enrollment, enabling recruitment of a more representative group of participants, and enhance the likelihood of complete and long-term follow-up, making each participant’s data maximally useful. We describe both practical considerations for use of digital platforms, as well as statistical techniques to adjust for participant mix, including population segmentation as a result of selection pressure based on recruitment approaches.