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Using Preliminary Data And Prospective Power Analyses For Mid-Stream Revision Of Projected Group And Subgroup Sizes In Pragmatic Patient-Centered Outcomes Research, Elizabeth A. Tolley Md, Satya Surbhi Md, James E. Bailey Md

Faculty Publications and Presentations

Pragmatic clinical trials are commonly used in patient-centered outcomes research to assess heterogeneity of treatment effects. Patient-Centered Outcomes Research Institute (PCORI) methodology standards for assessing heterogeneity of treatment effects are extremely rigorous, but their implementation in real-world settings can be difficult. Predicting recruitment effectiveness and subgroup characteristics is often challenging and may require mid-stream revision of projected group and subgroup sizes. Yet, little real-world data are available to demonstrate methodologically valid approaches to address situations where such revisions are necessary. These data were used for mid-stream revision of group and subgroup sizes in the Management of Diabetes in Everyday Life …