Objectives: What is an adverse event? What about adverse effects? Is a side effect and an adverse drug reaction the same thing? How one can determine an adverse effect as mild, serious, or severe? What is a rare event? What about a common one? This workshop is intended to answer these questions and related ones, i.e. to give guidance for review authors on terminology, frequency and severity classifications applied for adverse effects and how to overcome problems with misconceptions when extracting and analysing data on adverse effects.
Description: Participants will work in small groups to perform data extraction and plan data analysis based on different scenarios of trials investigating the efficacy and safety of an intervention for a given health problem. Groups will be challenged to collate and interpret data.
After group discussion, short presentations focused on terminology of adverse effects, frequency and severity classification schemes will be followed by a discussion on how the first data extraction and analysis plan could be enhanced in light of standard terminology and classification schemes. A sample of systematic reviews already published using mixed terminology will also be presented for group discussion.
Discussion papers will be drawn from a wide range of clinical situations. Participants will be encouraged to bring personal experiences and to suggest ways to improve Cochrane resources to support the assessment of adverse effects in systematic reviews.