Impact of missing participant data for dichotomous outcomes on pooled effect estimates in systematic reviews: a protocol for a methodological studyReportar como inadecuado




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Systematic Reviews

, 3:137

First Online: 26 November 2014Received: 30 October 2014Accepted: 13 November 2014DOI: 10.1186-2046-4053-3-137

Cite this article as: Akl, E.A., Kahale, L.A., Agarwal, A. et al. Syst Rev 2014 3: 137. doi:10.1186-2046-4053-3-137

Abstract

BackgroundThere is no consensus on how authors conducting meta-analysis should deal with trial participants with missing outcome data. The objectives of this study are to assess in Cochrane and non-Cochrane systematic reviews: 1 which categories of trial participants the systematic review authors consider as having missing participant data MPD, 2 how trialists reported on participants with missing outcome data in trials, 3 whether systematic reviewer authors actually dealt with MPD in their meta-analyses of dichotomous outcomes consistently with their reported methods, and 4 the impact of different methods of dealing with MPD on pooled effect estimates in meta-analyses of dichotomous outcomes.

Methods-DesignWe will conduct a methodological study of Cochrane and non-Cochrane systematic reviews. Eligible systematic reviews will include a group-level meta-analysis of a patient-important dichotomous efficacy outcome, with a statistically significant effect estimate. Teams of two reviewers will determine eligibility and subsequently extract information from each eligible systematic review in duplicate and independently, using standardized, pre-piloted forms. The teams will then use a similar process to extract information from the trials included in the meta-analyses of interest. We will assess first which categories of trial participants the systematic reviewers consider as having MPD. Second, we will assess how trialists reported on participants with missing outcome data in trials. Third, we will compare what systematic reviewers report having done, and what they actually did, in dealing with MPD in their meta-analysis. Fourth, we will conduct imputation studies to assess the effects of different methods of dealing with MPD on the pooled effect estimates of meta-analyses. We will specifically calculate for each method 1 the percentage of systematic reviews that lose statistical significance and 2 the mean change of effect estimates across systematic reviews.

DiscussionThe impact of different methods of dealing with MPD on pooled effect estimates will help judge the associated risk of bias in systematic reviews. Our findings will inform recommendations regarding what assumptions for MPD should be used to test the robustness of meta-analytical results.

KeywordsMissing participant data Imputation Risk of bias Trials Systematic reviews Meta-analysis AbbreviationsMPDmissing participant data

RoBrisk of bias

RRrelative risk

ORodds ratio

CIconfidence interval

RCTrandomized controlled trial

CCTcontrolled clinical trial

IQRinterquartile range

RINotFU-FUthe relative event incidence among those not followed-up relative to the event incidence among those followed-up

AMSTARa measurement tool to assess systematic reviews.

Electronic supplementary materialThe online version of this article doi:10.1186-2046-4053-3-137 contains supplementary material, which is available to authorized users.

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Autor: Elie A Akl - Lara A Kahale - Arnav Agarwal - Nada Al-Matari - Shanil Ebrahim - Paul Elias Alexander - Matthias Briel - R

Fuente: https://link.springer.com/



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