Reporting of randomized factorial trials was frequently inadequate

Brennan C Kahan, Michael Tsui, Vipul Jairath, Anna Mae Scott, Douglas G Altman, Elaine Beller, Diana Elbourne

Research output: Contribution to journalReview articleResearchpeer-review

2 Citations (Scopus)

Abstract

OBJECTIVE: Factorial designs can allow efficient evaluation of multiple treatments within a single trial. We evaluated the design, analysis, and reporting in a sample of factorial trials.

STUDY DESIGN AND SETTING: Review of 2x2 factorial trials evaluating health-related interventions and outcomes in humans. Using MEDLINE, we identified articles published between January 2015 and March 2018. We randomly selected 100 articles for inclusion.

RESULTS: Few trials (22%) provided a rationale for using a factorial design. Only 63 trials (63%) assessed the interaction for the primary outcome, and 39/63 (62%) made a further assessment for at least one secondary outcome. 12/63 trials (19%) identified a significant interaction for the primary outcome, and 16/39 trials (41%) for at least one secondary outcome. Inappropriate methods of analysis to protect against potential negative effects from interactions were common, with 18 trials (18%) choosing the analysis method based on a preliminary test for interaction, and 13% (n=10/75) of those conducting a factorial analysis including an interaction term in the model.

CONCLUSIONS: Reporting of factorial trials was often suboptimal, and assessment of interactions was poor. Investigators often used inappropriate methods of analysis to try to protect against adverse effects of interactions.

Original languageEnglish
Pages (from-to)52-59
Number of pages8
JournalJournal of Clinical Epidemiology
Volume117
Early online date1 Oct 2019
DOIs
Publication statusPublished - 1 Jan 2020

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