Objective:
This workshop aims to help reviewers to plan how to incorporate adverse effects into a systematic review. This will include the development of optimal search techniques and selection of appropriate studies.
Description:
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. Most reviewers are accustomed to evaluating effectiveness, but may be less conversant with the search techniques and data sources for adverse effects. We intend to highlight some of the methodological differences, and provide practical guidance on how to retrieve adverse effects data for a systematic review.
This will involve giving participants a number of scenarios; they will then work together in smaller groups to plan a protocol for evaluating adverse effects.
The scenarios will be drawn from real-life situations to cover a wide range of potential adverse effects, such as
1) The regulatory authority issues warnings about several new adverse effects with statins.
2) Two diabetes drugs are thought to cause heart failure and myocardial infarction.
3) A concerned consumer has heard that taking antidepressants and painkillers together can cause gastrointestinal bleeding.
A facilitator will help each group to address important aspects, including scope of the review, search strategies, types of studies to include. Facilitators will also help groups in drafting protocols for the systematic review of these safety concerns.
At the end, groups will then feed back on their protocols, and any points raised will be discussed further. The facilitators will provide examples from existing reviews, as well as tips and tricks to solve specific issues.