In Reply Many of the questions raised by Chapple and Blackston and by McDonald and colleagues about our recent Original Investigation1 are addressed in Pocock and Stone’s recent review on what to do when the primary outcome fails.2 Certainly, a trial in which the primary outcome falls short of statistical significance can be distressing to investigators. However, as highlighted by Chapple and Blackston, the interpretation of trial results may be colored by undue attention to a single primary outcome and arbitrary P value cut points. These constraints make sense in confirmatory studies of new drugs and devices (where the consequences of false positives can be dire) but not necessarily in more exploratory studies (like the Personalized Research for Monitoring Pain Treatment study3).
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Kravitz RL, Schmid CH, Sim I. Finding Benefit in n-of-1 Trials—Reply. JAMA Intern Med. 2019;179(3):455. doi:10.1001/jamainternmed.2018.8330
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