Incorporating data on adverse effects into systematic reviews

Topic category Other methods for preparing systematic reviews
Date and Location
Tuesday 2 October 2012 - 13:30 - 15:00
Methods Group
Methods Group: 
Adverse Effects Methods Group
Contact persons and facilitators
Contact person Affiliation Country
Christine Schmucker (Contact this person) German Cochrane Centre Germany
Facilitator Affiliation Country
Christine Schmucker German Cochrane Centre Germany
Other contributors
First nameLast nameAffiliation and Country
First name: 
Last name: 
Affiliation and Country: 
University of East Anglia, UK
Target audience
Target audience: 
Is your workshop restricted to a specific audience or open to all Colloquium participants?: 
Level of knowledge required: 
Type of workshop
Type of workshop: 
Abstract text
This workshop aims to give guidance for review authors on how to incorporate adverse effects data into systematic reviews. This will include selecting appropriate adverse outcomes for data extraction, and critical appraisal of validity.

A systematic review that considers only the favourable outcomes of an intervention, without also assessing adverse effects, can introduce a bias favouring the intervention. Most review authors are well-versed in evaluating effectiveness, but may be less conversant with methods for assessing safety. We will highlight some of the methodological differences, and provide practical guidance on how to include adverse effects in a systematic review. A number of scenarios will be presented to participants, who will work in small groups to plan selection criteria and practice data extraction and validity assessment for adverse effects. Scenarios will be drawn from real-life situations to cover a wide range of potential adverse effects, such as VEGF inhibitors in age-related macular degeneration. Examples from existing reviews will be provided, as well as tips and tricks to solve specific issues.

This workshop will focus on RCTs. Participants interested in non-randomised trials may be interested in the workshop, 'Methods for including non-randomised studies to answer questions about unintended harms of drugs'.