Background: more than one-third of systematic reviews do not appropriately address adverse events. When data on adverse events are assessed, they are frequently lumped together and reported as a general composite outcome of total adverse effects, eventually subgrouped in serious and non-serious events. This is problematic, as several different events are analyzed and interpreted in a broad and superficial approach. Whether applying a confirmatory or exploratory approach, review authors face significant challenges when extracting and synthesizing adverse events data in systematic reviews of interventions.
Objectives: this workshop is intended to explore challenges in extracting and analyzing adverse events data in systematic reviews. Relevant topics encountered by review authors will be examined:
- terminology challenges (e.g. adverse events, side effects, toxicities);
- classifications of frequency and seriousness;
- impact of case definitions and ascertainment on data extraction of adverse events;
- analytical approaches based on drug classification and organ systems.
Description: participants will identify terminology, classification, case definition and analytical challenges to assess data on adverse effects as reported in primary studies. We will draw practical case examples of different scenarios from a wide range of clinical situations. The group will have the opportunity to discuss each of the examples in small groups. Groups will be challenged to propose ways to collate and interpret the data available on the case examples. After the group discussion, the facilitator will present available models, strategies and guidance on how to extract and analyze data on adverse effects. We will present a sample of systematic reviews that have applied the strategies explored by the facilitator to support the group discussion and learning objectives. Participants will be encouraged to bring personal experiences and specific challenges and questions faced by review authors from low- and middle-income countries (LMICs). The facilitator, a researcher originally from Brazil and currently based in Canada, has faced first-hand the difficulties of learning methods and developing a systematic review in LMICs, and is well-positioned to discuss experiences on how to overcome these specific challenges. A final group discussion will encourage the group to propose key learning messages to improve the assessment of adverse effects in systematic reviews.