Core Outcome Measures in Effectiveness Trials

Development of a core outcome measurement set for clinical trials in whiplash associated disorders (WAD)

General Information

Inconsistent reporting of outcomes in clinical trials of treatments for whiplash associated disorders (WAD) hinders effective data pooling and conclusions that can be drawn about the effectiveness of tested treatments. This is especially important for WAD - a costly and predominantly compensable condition. There have been numerous cohort studies and randomised clinical trials conducted for WAD with many and varied outcome measures used, making it difficult to effectively pool data and usually precluding meta-analysis. These issues could be addressed through the development of a core outcome set (COS).
The overall aim of this project is to develop and disseminate a COS for clinical trials WAD.

Prof Michele Sterling, PhD Recover Injury Research Centre, University of Queensland, AUS
A/Prof Tonny Andersen, PhD, University of Southern Denmark, Denmark
Prof Linda Carroll, PhD, University of Alberta, Canada
Prof Luke Connelly, PhD, University of Queensland, AUS
Prof Pierre Côté, PhD, University of Toronto, Canada
Prof Michele Curatolo, University of Washington, USA
Prof James Elliott, University of Sydney, AUS
Dr Genevieve Grant, Monash University, AUS
Prof Gwendolen Jull, University of Queensland, AUS
Prof Helge Kasch, Aarhus University, Denmark
Prof Joy McDermid, Western University, Canada
Prof Samuel McLean, University of North Carolina, USA
Dr Mandy Nielsen, Chronic Pain Australia
Dr Trudy Rebbeck, University of Sydney, AUS
Prof Anne Soderlund, Mälardalen University, Sweden
Dr Julia Treleaven, University of Queensland, AUS

Further Study Information

Current Stage:
February 2018 - 2019
Funding source(s):
NHMRC Centre of Research Excellence in Road Traffic Injury Recovery. Grant ID: APP1079022

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Whiplash associated disorder

Target Population

Age Range
18 - 100


Nature / type of Intervention


Consensus meeting
Delphi process
Literature review
Semi structured discussion
Systematic review

The methods will include:
1) A comprehensive review of core domains used in clinical trials of WAD
2) An international Delphi study involving relevant stakeholders including patients, clinicians, clinical researchers and insurance personnel to define core outcome domains. A priori criteria for consensus will be established prior to the conduct of the Delphi study.
3) A consensus meeting consisting of a panel of experts with multidisciplinary expertise as well as patient and insurance representatives will be convened. The panel will discuss the results and vote on the core domains to be included.
4) Following completion of the identification of core outcome domains (steps 1-3), relevant systematic reviews will be conducted to identify and appraise the quality of outcome measures used for each domain. Protocols for systematic reviews will be registered in Prospero.
5) Consensus meeting with participants from Step 3 will be convened to discuss, vote on and recommend particular instruments for each core domain. For both consensus meetings, a priori criteria for consensus will be determined.

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Governmental agencies
Patient/ support group representatives
Policy makers

Study Type

COS for clinical trials or clinical research
COS for practice
Recommended outcome measures (measurement)

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