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Pre-specification of statistical analysis approaches in published clinical trial protocols was inadequate

Greenberg, L; Jairath, V; Pearse, R; Kahan, BC; (2018) Pre-specification of statistical analysis approaches in published clinical trial protocols was inadequate. Journal of Clinical Epidemiology , 101 pp. 53-60. 10.1016/j.jclinepi.2018.05.023. Green open access

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Abstract

OBJECTIVES: Results from randomized trials can depend on the statistical analysis approach used. It is important to prespecify the analysis approach in the trial protocol to avoid selective reporting of analyses based on those which provide the most favourable results. We undertook a review of published trial protocols to assess how often the statistical analysis of the primary outcome was adequately prespecified. METHODS: We searched protocols of randomized trials indexed in PubMed in November 2016. We identified whether the following aspects of the statistical analysis approach for the primary outcome were adequately prespecified: (1) analysis population; (2) analysis model; (3) use of covariates; and (4) method of handling missing data. RESULTS: e identified 99 eligible protocols. Very few protocols adequately prespecified the analysis population (8/99, 8%), analysis model (27/99, 27%), covariates (40/99, 40%), or approach to handling missing data (10/99, 10%). Most protocols did not adequately predefine any of these four aspects of their statistical analysis approach (39%) or predefined only one aspect (36%). No protocols adequately predefined all four aspects of the analysis. CONCLUSION: The statistical analysis approach is rarely prespecified in published trial protocols. This may allow selective reporting of results based on different analyses.

Type: Article
Title: Pre-specification of statistical analysis approaches in published clinical trial protocols was inadequate
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jclinepi.2018.05.023
Publisher version: https://doi.org/10.1016/j.jclinepi.2018.05.023
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisherís terms and conditions.
Keywords: Randomized controlled trial, Clinical trial, Statistical analysis, Pre-specification, Analysis switching
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
URI: https://discovery.ucl.ac.uk/id/eprint/10093412
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