Addressing Dichotomous Data for Participants Excluded from Trial Analysis : A Guide for Systematic Reviewers
Akl, Elie A. (McMaster University (Canadà))
Johnston, Bradley C. (McMaster University (Canadà))
Alonso-Coello, Pablo (Institut d'Investigació Biomèdica Sant Pau)
Neumann, Ignacio (McMaster University (Canadà))
Ebrahim, Shanil (McMaster University (Canadà))
Briel, Matthias (University Hospital Basel (Basel, Suïssa))
Cook, Deborah J. (McMaster University (Canadà))
Guyatt, Gordon (McMaster University (Canadà))

Date:	2013
Abstract:	Introduction: Systematic reviewer authors intending to include all randomized participants in their meta-analyses need to make assumptions about the outcomes of participants with missing data. Objective: The objective of this paper is to provide systematic reviewer authors with a relatively simple guidance for addressing dichotomous data for participants excluded from analyses of randomized trials. Methods: This guide is based on a review of the Cochrane handbook and published methodological research. The guide deals with participants excluded from the analysis who were considered 'non-adherent to the protocol' but for whom data are available, and participants with missing data. Results: Systematic reviewer authors should include data from 'non-adherent' participants excluded from the primary study authors' analysis but for whom data are available. For missing, unavailable participant data, authors may conduct a complete case analysis (excluding those with missing data) as the primary analysis. Alternatively, they may conduct a primary analysis that makes plausible assumptions about the outcomes of participants with missing data. When the primary analysis suggests important benefit, sensitivity meta-analyses using relatively extreme assumptions that may vary in plausibility can inform the extent to which risk of bias impacts the confidence in the results of the primary analysis. The more plausible assumptions draw on the outcome event rates within the trial or in all trials included in the meta-analysis. The proposed guide does not take into account the uncertainty associated with assumed events. Conclusions: This guide proposes methods for handling participants excluded from analyses of randomized trials. These methods can help in establishing the extent to which risk of bias impacts meta-analysis results.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	PloS one, Vol. 8, Núm. 2 (February 2013) , ISSN 1932-6203

DOI: 10.1371/journal.pone.0057132
PMID: 23451162

7 p, 369.8 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles