Objectives:

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.

Description:

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’.