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Systematic reviews of adverse effects: framework for a structured approach.


ABSTRACT:

Background

As every healthcare intervention carries some risk of harm, clinical decision making needs to be supported by a systematic assessment of the balance of benefit to harm. A systematic review that considers only the favourable outcomes of an intervention, without also assessing the adverse effects, can mislead by introducing a bias favouring the intervention. Much of the current guidance on systematic reviews is directed towards the evaluation of effectiveness; but this differs in important ways from the methods used in assessing the safety and tolerability of an intervention. A detailed discussion of why, how and when to include adverse effects in a systematic review, is required.

Methods

This discussion paper, which presupposes a basic knowledge of systematic revie

SUBMITTER: Loke YK 

PROVIDER: S-EPMC1933432 | biostudies-literature | 2007 Jul

REPOSITORIES: biostudies-literature