Pragmatic clinical trial investigators are typically expected, if not required, to specify in advance a detailed process for interpreting trial results. Applications for funding and trial registrations include specification of primary trial outcomes, plans for analyses, and thresholds for determining statistical significance. Power or sample size calculations typically specify thresholds for clinically meaningful differences in those primary outcomes. These practices satisfy the expectations of research funders, fellow researchers, and the reviewers and editors for scientific journals where results might eventually be published.

Pragmatic trials, however, aim to influence policy and everyday clinical practice. Consequently, investigators should consider how trial results and a more expansive set of outcomes could be most valuable to a wider range of “customers,” including policymakers, regulators, frontline clinicians, and health plan and medical group leaders. Those consumers of pragmatic trial results may often consider a wider range of outcomes than do research funders, fellow researchers, or journal reviewers. Health system leaders or policymakers may have thresholds for action that differ from traditional notions of a clinically meaningful difference in a single clinical outcome.

This chapter discusses how pragmatic trial investigators and study teams collaborate with health system parters to maximize the value of trial findings and experiences. Following the principles of engaged scholarship (Van De Ven 2007) and coproduction of research (Gremyr et al 2021), collaboration begins with trial planning and extends throughout trial implementation, data analysis, and reporting of results. In this model, investigators and study teams do not disseminate results to health system partners. Instead, investigators and study teams collaborate with health system partners to understand trial experiences, results, and implications for a variety of decision makers.

For more information on effective communication and collaboration with health system partners throughout the life cycle of a pragmatic trial, see the Living Textbook chapter on Building Partnerships and Teams to Ensure a Successful Trial.