Abstract
INTRODUCTION: Pragmatic clinical trials (PCTs) are frequently embedded within settings in which patients receive their routine clinical care. The health care institutions that deliver routine clinical care must therefore decide how they prioritize PCTs in comparison to other institutional priorities. Yet no formal guidance yet exists to support health care institutions' assessment and prioritization of PCTs. METHODS: Drawing on a critical review and synthesis of published literature and experience in PCTs, we developed a framework by which health care institutions can assess the appropriateness and feasibility of a given PCT within their system. RESULTS: We propose healthcare institutions assess the appropriateness of a given PCT through three lines of inquiry: (1) importance and timeliness of the research question, (2) feasibility of the study within the respective institution, and (3) institutional willingness to act on the study results. CONCLUSION: The proposed framework may support decision-making about whether to initiate a given PCT and also how to do so in a way that supports both research and operational priorities.