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, 12:179

First Online: 19 July 2011Received: 17 May 2011Accepted: 19 July 2011DOI: 10.1186-1745-6215-12-179

Cite this article as: Montgomery, A.A., Astin, M.P. & Peters, T.J. Trials 2011 12: 179. doi:10.1186-1745-6215-12-179


BackgroundStandards for the reporting of factorial randomised trials remain to be established. We aimed to review the quality of reporting of methodological aspects of published factorial trials of complex interventions in community settings.

MethodsWe searched MEDLINE, EMBASE, PsychInfo and the Cochrane Controlled Trials Register to identify factorial randomised trials of complex interventions in community settings from January 2000 to August 2009. We also conducted a citation search of two review papers published in 2003. Data were extracted by two reviewers on 22 items relating to study design, analysis and presentation.

ResultsWe identified 5941 unique titles, from which 116 full papers were obtained and 76 were included in the review. The included trials reflected a broad range of target conditions and types of intervention. The median sample size was 400 interquartile range 191-1001. Most 88% trials employed a 2 × 2 factorial design. Few trials 21% explicitly stated the rationale for using a factorial design. Reporting of aspects of design, analysis or presentation specific to factorial trials was variable, but there was no evidence that reporting of these aspects was different for trials published before or after 2003. However, for CONSORT items that apply generally to the reporting of all trials, there was some evidence that later studies were more likely to report employing an intention-to-treat ITT approach 78% vs 52%, present appropriate between-group estimates of effect 88% vs 63%, and present standard errors or 95% confidence intervals for such estimates 78% vs 56%. Interactions between interventions and some measure of the precision associated with such effects were reported in only 14 18% trials.

ConclusionsReports of factorial trials of complex interventions in community settings vary in the amount of information they provide regarding important methodological aspects of design and analysis. This variability supports the extension of CONSORT guidelines to include the specific reporting of factorial trials.

List of abbreviationsCONSORTConsolidated Standards of Reporting Trials


MeSHMedical Subject Heading

MRCMedical Research Council

RCTRandomised Controlled Trial.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-12-179 contains supplementary material, which is available to authorized users.

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Autor: Alan A Montgomery - Margaret P Astin - Tim J Peters


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