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Recommendations For Core Outcome Domain Set For Whiplash-Associated Disorders (CATWAD)

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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.

Materials and Methods:

A 3-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 3-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. A total of 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, 6 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.
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Keywords: domains; neck; outcome; pain; whiplash

Document Type: Research Article

Affiliations: 1: Recover Injury Research Centre, NHMRC Centre of Research Excellence in Road Traffic Injury Recovery, The University of Queensland, Herston 2: Department of Psychology, University of Southern Denmark, Odense M 3: School of Public Health, University of Alberta, Edmonton, AB 4: NHMRC Centre of Research Excellence in Road Traffic Injury Recovery, The University of Queensland, Herston, The University of Queensland Centre for the Business and Economics of Health, PACE, Woollongabba, Queensland, Department of Sociology and Business Law, The University of Bologna, Bologna, Italy 5: Faculty of Health Sciences, University of Ontario Institute of Technology, UOIT-CMCC Centre for Disability Prevention and Rehabilitation, Oshawa, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada 6: Department of Anesthesiology & Pain Medicine, University of Washington, Seattle, WA 7: Department of Physical Therapy and Human Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, Faculty of Health Sciences, The University of Sydney, Sydney, NSW 8: NHMRC Centre of Research Excellence in Road Traffic Injury Recovery, The University of Queensland, Herston, Faculty of Law, Australian Centre for Justice Innovation (ACJI), Monash University, Melbourne, Vic. 9: Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia 10: Research Unit, Spinal Cord Injury Centre of Western Denmark, Department of Neurology, Regional Hospital of Viborg, Viborg, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark 11: School of Physical Therapy, Western University, Australia, Hand and Upper Limb Centre, St. Joseph’s Health Centre, London, ON, Canada 12: Department of Pain Rehabilitation, Skåne University Hospital, Department of Clinical Sciences, Lund University, Lund 13: Department of Anesthesiology, Institute for Trauma Recovery, University of North Carolina School of Medicine, Chapel Hill, NC 14: Chronic Pain Australia, Sydney, NSW, Australia 15: NHMRC Centre of Research Excellence in Road Traffic Injury Recovery, The University of Queensland, Herston, Faculty of Health Sciences, The University of Sydney, Sydney, NSW 16: Department of Physiotherapy, School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden 17: Recover Injury Research Centre 18: School of Physical Therapy, Western University, Australia 19: Recover Injury Research Centre, NHMRC Centre of Research Excellence in Road Traffic Injury Recovery, The University of Queensland, Herston, Menzies Health Institute Queensland, Griffith University, Parklands

Publication date: September 1, 2019

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