Article type
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Abstract
Objectives: This workshop aims to give guidance for review authors on how to incorporate adverse effects into systematic reviews. This will include the development of optimal search techniques, selection of appropriate study designs and critical appraisal of data.
Summary: 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 review authors are well versed in the evaluation of effectiveness, but may be less conversant with the methods for assessing the safety of an intervention. We intend to highlight some of the methodological differences, and provide practical guidance on how to include adverse effects in a systematic review. This will involve giving a number of scenarios to participants, who 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:
- A widely used childhood vaccine is claimed to be responsible for a rare, previously unrecognized serious neurological problem.
- A breast cancer 'wonder drug' hits the headlines, but severe heart failure is a well-recognized adverse reaction in the trials.
- A major surgical procedure saves lives in the long-term, but the procedure may potentially cause serious harm in certain patient groups, such as those over 80 years of age.
- An innovative insulin inhaler device is launched which claims to be better tolerated and more acceptable in daily use to patients than the existing injections.
Each group will be provided with a facilitator who will help them address important aspects including - scope of the review, search strategies, types of studies to include, quality assessment, data analysis and interpretation. Facilitators will also assist groups in drafting protocols for the systematic review of these safety concerns. At the end, groups will then feedback on their protocols, and any points raised will be discussed further. Examples from existing reviews will be provided by the facilitators, as well as tips and tricks to solve specific issues.
Level of knowledge required to attend: basic/intermediate/advanced.
Summary: 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 review authors are well versed in the evaluation of effectiveness, but may be less conversant with the methods for assessing the safety of an intervention. We intend to highlight some of the methodological differences, and provide practical guidance on how to include adverse effects in a systematic review. This will involve giving a number of scenarios to participants, who 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:
- A widely used childhood vaccine is claimed to be responsible for a rare, previously unrecognized serious neurological problem.
- A breast cancer 'wonder drug' hits the headlines, but severe heart failure is a well-recognized adverse reaction in the trials.
- A major surgical procedure saves lives in the long-term, but the procedure may potentially cause serious harm in certain patient groups, such as those over 80 years of age.
- An innovative insulin inhaler device is launched which claims to be better tolerated and more acceptable in daily use to patients than the existing injections.
Each group will be provided with a facilitator who will help them address important aspects including - scope of the review, search strategies, types of studies to include, quality assessment, data analysis and interpretation. Facilitators will also assist groups in drafting protocols for the systematic review of these safety concerns. At the end, groups will then feedback on their protocols, and any points raised will be discussed further. Examples from existing reviews will be provided by the facilitators, as well as tips and tricks to solve specific issues.
Level of knowledge required to attend: basic/intermediate/advanced.