Quality in reporting adverse events and the PRISMA Harms Extension

Tags: Workshop
Zorzela L1, Vohra S1, Golder S2, Loke Y3, Moher D4, Altman DG5, Ioannidis JP6, Vandenbroucke J7, Santaguinda L8, Golder S9
1University of Alberta, Canada, 2CRD, United Kingdom, 3University of East Anglia, UK, 4Ottawa Health Research Institute, Canada, 5Oxford University, UK, 6Stanford University, United States, 7Leiden University, Netherlands, 8McMaster University, Canada, 9York University, UK

Objectives:

(i) Enable participants to identify the pitfalls/ difficulties/problems in reporting adverse events. (ii) Provide guidance on how to report adverse effects in reviews (PRISMA Harms Extension). (iii) Allow participants to practice methods of clear reporting of adverse events in reviews.

Description:

Present the quality issues in reporting adverse effects using ‘Quality in reporting in systematic reviews of adverse events. A systematic review.’ (15 minutes) Present a tool to assess the quality of reporting in reviews: The PRISMA Harms Extension + final checklist items. (15 minutes) The participants will break into small groups to apply the PRISMA Harms Extension checklist in systematic reviews of adverse events. They will assess 2–4 published reviews. The example reviews will include reviews with good reporting quality and reviews with fair (not good) reporting of adverse events (60 minutes). After each assessment the participants will discuss the application of the guidance and issues raised in assessing the reporting of adverse effects in reviews. This section will be an open for questions/discussion among participants.