A core outcome set for clinical trials in whiplash-associated disorders (WAD): a study protocol.

BACKGROUND

Whiplash-associated disorders (WAD) as a consequence of a motor vehicle crash are a costly health burden in Western societies. Up to 50% of injured people do not fully recover. There have been numerous clinical trials and cohort studies conducted for WAD with many varied outcome measures used, making data pooling difficult and hindering meta-analysis. These issues could be addressed through the development of a core outcome set (COS) that should be included in all clinical trials for WAD. The purpose of this project is to develop and disseminate a COS for clinical trials in WAD.

METHODS/DESIGN: An international Steering Committee was formed to initiate and support the development of this COS. The project will comprise five phases: (1) a comprehensive review of core outcome domains used in clinical trials in WAD, (2) an international Delphi survey including individuals with WAD, health care providers, clinical researchers and insurance personnel to define the core outcome domains, (3) a meeting of relevant stakeholders to reach consensus regarding the final core outcome domains, (4) identification and evaluation of instruments used to measure the final core outcome domains, and (5) a consensus meeting to agree on the core outcome measurement instruments to be used.

DISCUSSION

The aim of this proposal is to complete a five-stage process to develop a COS for all clinical trials in WAD. An implementation strategy will also be proposed.