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How much variation in the non-surgical care is acceptable? Can different study sites use different approaches to non-surgical care? How should applicants approach the issue of fidelity and intensity of the non-surgical care?

PCORI recognizes that there are a number of models of multidisciplinary nonsurgical treatment that vary in their components and intensity. Applicants should justify the model that they propose for the study comparator arm on the basis of convincing evidence regarding its efficacy as a program or its component interventions. In addition, the study should collect sufficient data about the multidisciplinary intervention to allow replication by future users of the study results. Given that the use of different approaches for different sites may introduce complexity into the study design, possibly reduce clinical equipoise, and reduce power, if multiple approaches are used there should be a strong justification.

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