Recommendations for a core outcome measurement set for clinical trials in whiplash associated disorders

Michele Sterling; Tonny Andersen; Linda Carroll; Luke Connelly; Pierre Côté; Michele Curatolo; Genevieve Grant; Gwendolen Jull; Helge Kasch; Sophie Lykkegaard Ravn; Joy MacDermid; Eva-Maj Malmström; Trudy Rebbeck; Anne Söderlund; Julia Treleaven; David M Walton; Hans Westergren

doi:10.1097/j.pain.0000000000002926

Recommendations for a core outcome measurement set for clinical trials in whiplash associated disorders

Pain. 2023 Oct 1;164(10):2265-2272. doi: 10.1097/j.pain.0000000000002926. Epub 2023 May 10.

Authors

Michele Sterling^{1

2}, Tonny Andersen³, Linda Carroll⁴, Luke Connelly^{2

5

6}, Pierre Côté^{7

8

9}, Michele Curatolo^{10

11}, Genevieve Grant^{2

12}, Gwendolen Jull¹³, Helge Kasch^{14

15

16}, Sophie Lykkegaard Ravn^{3

17}, Joy MacDermid^{18

19}, Eva-Maj Malmström²⁰, Trudy Rebbeck^{2

21}, Anne Söderlund²², Julia Treleaven¹³, David M Walton¹⁸, Hans Westergren²⁰

Affiliations

¹ Recover Injury Research Centre, The University of Queensland, Herston, Australia.
² NHMRC Centre of Research Excellence: Better Health Outcomes for Compensable Injury, The University of Queensland, Herston, Australia.
³ Department of Psychology, University of Southern Denmark, Odense M, Denmark.
⁴ School of Public Health, University of Alberta, Edmonton, Alberta, Canada.
⁵ The University of Queensland Centre for the Business and Economics of Health, Sir Llew Edwards Building, St Lucia, Australia.
⁶ Departmento di Sociologia e Diritto Dell'Economia, The University of Bologna, Bologna, Italy.
⁷ Faculty of Health Sciences, University of Ontario Institute of Technology, Oshawa, ON, Canada.
⁸ Institute for Disability and Rehabilitation Research, Oshawa, ON, Canada.
⁹ Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
¹⁰ Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States.
¹¹ Clinical Learning, Evidence and Research (CLEAR) Center for Musculoskeletal Disorders, Harborview Injury Preventions and Research Center (HIPRC), University of Washington, Seattle, WA, United States.
¹² Faculty of Law, Australian Centre for Justice Innovation (ACJI), Monash University, Melbourne, Australia.
¹³ School of Health and Rehabilitation Sciences, The University of Queensland, Queensland, Australia.
¹⁴ Research Unit, Spinal Cord Injury Centre of Western Denmark, Viborg, Denmark.
¹⁵ Department of Neurology, Regional Hospital of Viborg, Viborg, Denmark.
¹⁶ Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
¹⁷ Specialized Hospital for Polio and Accident Victims, Rødovre, Denmark.
¹⁸ School of Physical Therapy, Western University, London, ON Canada.
¹⁹ Hand and Upper Limb Centre, St. Joseph's Health Centre, London, ON Canada.
²⁰ Department of Pain Rehabilitation, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.
²¹ Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
²² Department of Physiotherapy, School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.

PMID: 37171189
DOI: 10.1097/j.pain.0000000000002926

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Clinical Trials as Topic
Humans
Pain / complications
Pain Measurement
Quality of Life*
Treatment Outcome
Whiplash Injuries* / complications
Whiplash Injuries* / psychology
Whiplash Injuries* / therapy