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Intention-to-treat analysis may be more...
Journal article

Intention-to-treat analysis may be more conservative than per protocol analysis in antibiotic non-inferiority trials: a systematic review

Abstract

BackgroundIn non-inferiority trials, there is a concern that intention-to-treat (ITT) analysis, by including participants who did not receive the planned interventions, may bias towards making the treatment and control arms look similar and lead to mistaken claims of non-inferiority. In contrast, per protocol (PP) analysis is viewed as less likely to make this mistake and therefore preferable in non-inferiority trials. In a systematic review of …

Authors

Bai AD; Komorowski AS; Lo CKL; Tandon P; Li XX; Mokashi V; Cvetkovic A; Findlater A; Liang L; Tomlinson G

Journal

BMC Medical Research Methodology, Vol. 21, No. 1,

Publisher

Springer Nature

Publication Date

December 2021

DOI

10.1186/s12874-021-01260-7

ISSN

1471-2288