Core Outcome Measures in Effectiveness Trials

Recommendations for Core Outcome Domain Set for Whiplash Associated Disorders (CATWAD)

General Information

Abstract:
OBJECTIVE: 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. The aim of this study was to provide recommendations for core outcome domains that should be included in clinical trials of WAD. METHODS: A three-step process was used. (1) A list of potential core outcome domains were identified from the published literature; (2) Researchers, health care providers, patients and insurance personnel participated and rated the importance of each domain via a three round Delphi survey. A priori criteria for consensus were established; 3) Experts comprising researchers, health care providers and a consumer representative participated in a multidisciplinary consensus meeting that made final decisions on the recommended core outcome domains. RESULTS: The literature search identified 63 potential core domains. 223 participants were invited to partake in the Delphi surveys with 41.7% completing Round 1, 45.3% Round 2 and 51.4% Round 3. Eleven core domains met the criteria for inclusion across the entire sample. After the expert consensus meeting, six core domains were recommended: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life and Pain. DISCUSSION: A 3-step process was used to recommend core outcome domains for clinical trials in WAD. Six core domains were recommended: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life and Pain. The next step is to determine the outcome measurement instruments for each of these domains.

Authors:
Chen, K. Andersen, T. Carroll, L. Connelly, L. Cote, P. Curatolo, M. Elliott, J. Grant, G. Jull, G. Kasch, H. MacDermid, J. Malmstrom, E. M. Maujean, A. McLean, S. A. Nielsen, M. Rebbeck, T. Soderlund, A. Sterling, J. Treleaven, J. Walton, D. M. Westergren, H. Sterling, M.

Publication

Journal:
Clin J Pain
Volume:
Issue:
Pages:
-
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Whiplash associated disorder

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Literature review

A three-step process was used. 1) A list of potential core outcome domains were identified from the published literature; 2) Researchers, health care providers, patients and insurance personnel participated and rated the importance of each domain via a three round Delphi survey. A priori criteria for consensus were established; 3) Experts comprising researchers, health care providers and a consumer representative participated in a multidisciplinary consensus meeting that made final decisions on the recommended core outcome domains.


Stakeholders Involved

Clinical experts
Consumers (patients)
Health insurance company representatives
Researchers

Study Type

COS for clinical trials or clinical research

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.