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Recommendations for a core outcome measurement set for clinical trials in whiplash associated disorders
Recover Injury Research Centre, University of Queensland, Herston, Australia.
Department of Psychology, University of Southern Denmark, Odense M, Denmark.
School of Public Health, University of Alberta, Edmonton, AB, Canada.
NHMRC Centre of Research Excellence: Better Health Outcomes for Compensable Injury, University of Queensland, Herston, Australia.
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2023 (English)In: Pain, ISSN 0304-3959, E-ISSN 1872-6623, Vol. 164, no 10, p. 2265-2272Article in journal (Refereed) Published
Abstract [en]

ABSTRACT: Inconsistent reporting of outcomes in clinical trials of treatments for whiplash associated disorders (WAD) hinders effective data pooling and conclusions about treatment effectiveness. A multidisciplinary International Steering Committee recently recommended 6 core outcome domains: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life and Pain. This study aimed to reach consensus and recommend a core outcome set (COS) representing each of the 6 domains. Forty-three patient-reported outcome measures (PROMs) were identified for Physical Functioning, 2 for perceived recovery, 37 for psychological functioning, 17 for quality of life, and 2 for pain intensity. They were appraised in 5 systematic reviews following COSMIN methodology. No PROMs of Work and Social Functioning in WAD were identified. No PROMs had undergone evaluation of content validity in patients with WAD, but some had moderate-to-high-quality evidence for sufficient internal structure. Based on these results, the International Steering Committee reached 100% consensus to recommend the following COS: Neck Disability Index or Whiplash Disability Questionnaire (Physical Functioning), the Global Rating of Change Scale (Perceived Recovery), one of the Pictorial Fear of Activity Scale-Cervical, Pain Self-Efficacy Questionnaire, Pain Catastrophizing Scale, Harvard Trauma Questionnaire, or Posttraumatic Diagnostic Scale (Psychological Functioning), EQ-5D-3L or SF-6D (Quality of Life), numeric pain rating scale or visual analogue scale (Pain), and single-item questions pertaining to current work status and percent of usual work (Work and Social Functioning). These recommendations reflect the current status of research of PROMs of the 6 core outcome domains and may be modified as evidence grows.

Place, publisher, year, edition, pages
NLM (Medline) , 2023. Vol. 164, no 10, p. 2265-2272
Keywords [en]
Humans, Pain, Pain Measurement, Quality of Life, Treatment Outcome, Whiplash Injuries, complication, human, psychology, whiplash injury
National Category
Health Sciences
Identifiers
URN: urn:nbn:se:mdh:diva-64442DOI: 10.1097/j.pain.0000000000002926ISI: 001073695400012PubMedID: 37171189Scopus ID: 2-s2.0-85171393801OAI: oai:DiVA.org:mdh-64442DiVA, id: diva2:1802777
Available from: 2023-10-05 Created: 2023-10-05 Last updated: 2023-11-15Bibliographically approved

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Söderlund, Anne

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