Methods for including non-randomised studies to answer questions about unintended harms of drugs

Topic category Other methods for preparing systematic reviews
Date and Location
Wednesday 3 October 2012 - 13:30 - 15:00
Methods Group
Methods Group: 
Non-Randomised Studies Methods Group
Contact persons and facilitators
Contact person Affiliation Country
Barnaby Reeves (Contact this person) Non-Randomised Studies Methods Group United Kingdom
Facilitator Affiliation Country
Barnaby Reeves Non-Randomised Studies Methods Group United Kingdom
Other contributors
First nameLast nameAffiliation and Country
First name: 
Last name: 
Affiliation and Country: 
CIETCanada, Canada
First name: 
Last name: 
Affiliation and Country: 
Ottawa Heart Institute, Canada
First name: 
Last name: 
Affiliation and Country: 
University of East Anglia, UK
Target audience
Target audience: 
Authors, editors and methodologists considering when and how to include non-randomised studies in Cochrane Reviews to answer questions about unintended harms of drugs
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
The workshop will present a framework for considering harms of interventions and propose methods for including non-randomised studies (NRS) to answer questions about unintended harms of drugs.

The need to include NRS is likely to arise when suspected harms are serious and rare or occur in the long term, situations which are rarely addressed by randomised controlled trials (RCTs). Nevertheless, including evidence about such harms is important in order to present a balanced review of the effects of an intervention, as highlighted by stakeholders in The Cochrane Collaboration.

The facilitator will first present the proposed framework. Participants will work in small groups to discuss the steps identified in the framework:
• at the protocol stage, prioritising harms to review;
• searching for NRS about the nominated harms;
• defining eligible NRS;
• evidence synthesis; and
• interpreting heterogeneity.

Small groups will feedback their conclusions. Then all participants will consider whether there is sufficient consensus about the methods to recommend that they be proposed as guidance to Cochrane Review Groups.

Participants interested in incorporating evidence from RCTs on adverse effects may be interested in the workshop, 'Incorporating data on adverse effects into systematic reviews'.