PCORI Help Center

If I have a design that compares the effectiveness of two alternatives, would it be acceptable to include usual care as a third arm?

A third, usual-care arm may be acceptable, provided you give appropriate justification for including a usual-care arm and describe how you will measure the components of the care received. “Usual care” (or no specific intervention) may be an appropriate comparator if this is a realistic choice faced by patients and other stakeholders, but the clinical characteristics must be specified.

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