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Extending the assessment of outcome reporting bias to harms

Date and Location




Friday 20 September 2013 - 15:30 - 17:00
Methods Group and core training

Methods Group

Adverse Effects Methods Group
Contact persons and facilitators

Contact person

Jamie Kirkham


Jamie Kirkham
Pooja Saini
Kerry Dwan
Paula Williamson
Other contributors
First nameLast nameAffiliation and Country

First name


Last name


Affiliation and Country

University of East Anglia, UK

First name


Last name


Affiliation and Country

University of Oxford, UK

First name


Last name


Affiliation and Country

University of Liverpool, UK
Target audience

Target audience

Review authors, policy makers, researchers with an interest in bias and adverse effects

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 discuss how reviewers decide what harm outcomes to include in their reviews. • To provide the reviewer with a background to the problem and mechanisms that may lead to incomplete reporting of harms data. • To discuss how a reviewer might identify outcome reporting bias (ORB) for harms in their review. • To present techniques for assessing the robustness of the meta-analysis to such bias. Description: Empirical research has demonstrated that harms are poorly reported in clinical trials. Important harm outcomes maybe subject to outcome reporting bias (ORB) where trialists prefer to focus on the positive benefits of an experimental intervention. Methods for the identification of ORB in harm outcomes for an individual study will be described and illustrated using examples. We will also remind reviewers about assessing ORB for benefit outcomes. Participants will be encouraged to undertake such assessments for examples provided and to discuss issues for their reviews. Sensitivity approaches for adjusting for this form of bias will be described and methods for implementation will be provided. Considerations for the impact ORB can have on the benefit-harm ratio with and without adjustment will also be presented.