In a JAMA Viewpoint published online this week, leaders from the NIH Pragmatic Trials Collaboratory discuss the discordance between the results of pragmatic clinical trials and the implementation of those results in healthcare settings, even in settings that championed the work.

Coauthors Richard Platt, Hayden Bosworth, and Gregory Simon posit that, to provide evidence that healthcare systems leaders will actually use, changes are necessary:

• Trials need to be faster (2 to 3 years)
• Trials should consider outcomes that healthcare system leaders care about (such as costs and subgroup analyses)
• The evidence required for change should be at the level that healthcare system leaders use (such as not necessarily rejecting the null hypothesis at P < .05 but also considering results of Bayesian methods and interim analyses)

Read the full article.

“We believe it is possible to make pragmatic clinical trials of policies and procedures more useful to delivery systems by accommodating their priorities, introducing flexibility in the level of evidence trials require, shortening the duration of planning and implementation, addressing system leaders’ interest in multiple outcomes and subgroup analyses, encouraging modification of protocols during the implementation phase, and by providing timely interim analyses that can guide decisions about continuing or modifying an intervention,” the authors wrote.

This work was based on an NIH Pragmatic Trials Collaboratory workshop held in 2023, Getting the Right Evidence to Decision-Makers Faster. The workshop explored the critical cycle of evidence generation to decision by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

Platt is a cochair of the NIH Collaboratory’s Distributed Research Network and the Harvard Pilgrim Health Care Institute Distinguished Professor of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School. Bosworth is a cochair of the Implementation Science Core and a professor in population health sciences at Duke University. Simon is the chair of the Health Care Systems Interactions Core and a senior investigator at the Kaiser Permanente Washington Health Research Institute.

View the full workshop materials.