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).
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
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
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: