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Abstract - Final – Mar. 3, 2011

Methods for Balancing Harms and Benefits in Systematic Reviews

Topic Abstract

Background: Systematic reviews of interventions separately report on a range of patient relevant outcomes. However systematic reviews are increasingly challenged by the lack of guidance on how to report, synthesize, analyze and quantify the balance of benefits and harms important for various stakeholders with varying preferences.

Objective: The objective of this methods project is to describe the methodological issues that challenge quantitative summaries of benefit/harm balance in systematic reviews of interventions.

Methods: We will develop guiding principles for reporting, analysis and presentation of benefits and harms in systematic reviews by the EPCs so that stakeholders and decision-makers are better able to weigh the benefits and harms (including adverse outcomes and burdens) for a population, as well as for subgroups for whom this balance may vary. Using the principles developed this methods report will demonstrate the application of one (or two) existing quantitative risk benefit assessment methods to a key question from an existing EPC systematic review. The guiding principles and methods developed in this report could prove useful for systematic reviewers and decision makers who rely on the results of systematic reviews.