Interpreting trial results following use of different intention-to-treat approaches for preventing attrition bias: a meta-epidemiological study protocol

Anna Dossing, Simon Tarp, Daniel E Furst, Christian Gluud, Joseph Beyene, Bjarke B Hansen, Henning Bliddal, Robin Christensen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstrakt

INTRODUCTION: When participants drop out of randomised clinical trials, as frequently happens, the intention-to-treat (ITT) principle does not apply, potentially leading to attrition bias. Data lost from patient dropout/lack of follow-up are statistically addressed by imputing, a procedure prone to bias. Deviations from the original definition of ITT are referred to as modified intention-to-treat (mITT). As yet, the impact of the potential bias associated with mITT has not been assessed. Our objective is to investigate potential bias and disadvantages of performing mITT and evaluate possible concerns when executing different mITT approaches in meta-analyses.

METHODS AND ANALYSIS: Using meta-epidemiology on randomised trials considered less prone to bias (ie, good internal validity) and assessing biological or targeted agents in patients with rheumatoid arthritis, we will meta-analyse data from 10 biological and targeted drugs based on collections of trials that would correspond to 10 individual meta-analyses.

ETHICS AND DISSEMINATION: This study will enhance transparency for evaluating mITT treatment effects described in meta-analyses. The intended audience will include healthcare researchers, policymakers and clinicians. Results of the study will be disseminated by peer-review publication.

PROTOCOL REGISTRATION: In PROSPERO CRD42013006702, 11. December 2013.

OriginalsprogEngelsk
Artikelnummere005297
TidsskriftBMJ Open
Vol/bind4
Udgave nummer9
ISSN2044-6055
DOI
StatusUdgivet - 26. sep. 2014
Udgivet eksterntJa

Bibliografisk note

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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