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Summarising evidence for harms in systematic reviews - Part 1

Date and Location




Sunday 22 September 2013 - 15:30 - 17:00
Methods Group and core training

Methods Group

Adverse Effects Methods Group
Contact persons and facilitators

Contact person

Andrew Herxheimer


Andrew Herxheimer
Other contributors
First nameLast nameAffiliation and Country

First name


Last name


Affiliation and Country

Univ of East Anglia UK
Target audience

Target audience

review authors and editors and consumers

Is your workshop restricted to a specific audience or open to all Colloquium participants?


Level of knowledge required

Type of workshop

Type of workshop

Abstract text


Objectives: Most clinical trial reports say too little about adverse events (AEs) or harms that occur during or after the trial. Few adequately describe AEs and their timing, nor how they were ascertained. Beneficial effects get much more space in reports than harms, and this seriously biases assessment of the benefit/ harm relationship. The workshop should help authors and editors to correct this imbalance. Description: The introduction will explain that the evidence hierarchy for harms differs from that for beneficial effects, and that essential qualitative and quantitative evidence also comes from sources other than clinical trials (Vandenbroucke 2008). The workshop will break into groups to discuss different reviews and RCTs, and assess the ways in which they deal with AEs and the likely bias in their approach. Finally the whole workshop will consider the work of the small groups, and discuss how they want to use the conclusions in future. Those present will be invited to take part in future work on how to address these problems. Vandenbroucke JP. Observational research, randomised trials and two views of medical science. PLoS Medicine 2008; 5(3):e67