Skip to main content


Extending the Risk of Bias Tool to allow for assessment of non-randomised studies, cluster-randomised trials and cross-over trials: A Cochrane Methods Innovation Fund Project

Date and Location




Sunday 22 September 2013 - 13:30 - 15:00


Methods Group and core training

Methods Group

Bias Methods Group
Contact persons and facilitators

Contact person

Lucy Turner
Jelena Savovic


Jonathan Sterne
Julian Higgins
Barnaby Reeves
Other contributors
First nameLast nameAffiliation and Country

First name


Last name


Affiliation and Country

University of Bristol, England

First name


Last name


Affiliation and Country

Ottawa Hospital Research Institute, Canada

First name


Last name

Members and leads of eight other working groups

Affiliation and Country

Bias Methods and Non-randomised Studies Methods Group
Target audience

Target audience

Review authors, review editors, methodologists and other researchers.

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 To introduce a proposed extension to the Cochrane risk of bias tool allowing risk of bias assessment of non-randomised studies, cluster-randomised trials and cross-over trials, and to solicit feedback and identify potential areas for improvement which should be addressed. Description The Collaboration needs a tool to assess the potential risk of bias in non-randomised studies. The Cochrane Methods Innovation Fund has commissioned a project, led by the Bias Methods Group and the Non-Randomised Studies Methods Group to extend the existing Risk of Bias tool to address non-randomised studies, as well as to address variations on randomised trial designs not well covered by the existing tool (specifically cluster-randomised trials and cross-over trials). Working groups have been focusing on different aspects of bias or study design, and a provisional tool has emerged. This discussion workshop will introduce the project, present the current version of the extended tool and provide an opportunity for discussion of potential concerns or questions. The objective of the workshop is to highlight areas for development which have not already been addressed and which should be considered prior to the tool being disseminated collaboration wide. Considerations for discussion will include scientific issues, feasibility issues, roll-out and training opportunities.