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


ABSTRACT:

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 vali

SUBMITTER: Dossing A 

PROVIDER: S-EPMC4179424 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature