Reporting adverse events in reviews and the PRISMA Harms

Article type
Authors
Zorzela L1, Golder S2, Junqueira D3, Vohra S4
1AEMG, University of Alberta
2Cochrane Adverse Effects Methods Group
3Adverse Effects Methods Group
4University of Alberta, Canada
Abstract
Objectives:
1. Understand the particularities of reporting adverse events in reviews.
2. Use the PRISMA Harms as a reporting tool for adverse events in reviews.
Description: As adverse events are often rare, systematic reviews can provide valuable information to describe them, but the lack of standardized methods to report them and the fact that harms are not usually the primary outcome of included studies makes it a difficult task.
The workshop will consist of:
1. Introductions: facilitators will introduce themselves and their backgrounds. If a small group of participants is present (less than 15) they may also introduce themselves and their backgrounds concisely. This portion should not take longer than 5 minutes.
2. Understanding the problem: poor reporting in systematic reviews of adverse events. The facilitator will present the findings of a systematic review measuring the report weaknesses in other systematic reviews of adverse events (5 minutes).
3. Potential solutions: The development of PRISMA Harms and the final checklist items will be presented (5 minutes).
4. Hands on: The participants will break into small groups (five to seven people in each to facilitate communication) and develop a ‘fake’ review of adverse events, developing a PICO and describing methods of reporting searching, screening, data collection and results with a main focus on the particularities of reviews measuring adverse events. (60 minutes).
5. Questions and comments (15 minutes).