Randomized controlled trials (RCTs) are preferred; however, well-designed and well-justified prospective observational studies will also be considered if an RCT is not feasible. Applications for large studies are required to have an implementation aim. As a result, thoughtful use of hybrid designs such as hybrid type 1 and hybrid type 2 designs are encouraged. The use of qualitative and mixed methods is also encouraged. Applicants should refer to PCORI’s Methodology Standards for Qualitative Research and Mixed Methods Research for additional guidance. This is not a requirement for small studies.
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