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  • Interpretation of extension to the consolidated standards of reporting trials (CONSORT) 2010 statement for factorial randomized trials

    Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which two or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal. A consensus-based extension to the consolidated standards of reporting trials (CONSORT) 2010 statement for factorial trials was developed based on the enhancing the quality and transparency of health research (EQUATOR) methodological framework. In the study, we introduced and interpreted the extension of the CONSORT 2010 statement for factorial design in which 16 items were modified and one new item was added and presented an example of a factorial trial in mental health to provide guidance on the reporting of factorial randomized trials.

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