The DOI matches its Crossref record; 37 of the 37 references it cites were found in a registry or an index.
Recommendations for a core outcome measurement set for clinical trials in whiplash associated disorders
Abstract
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.
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In the citing paper
“They suggested the lack of consistency reduced opportunities for data pooling and therefore conclusions regarding the efficacy of treatments.”
From Impact of healthcare interventions on distress following acute musculoskeletal/orthopaedic injury: A scoping review of systematic reviews (2024) · cites this paper as [118]
In the citing paper
“In a recent article, Sterling et al discussed the inconsistency of reporting of outcomes in clinical trials of treatments for WAD.118”
From Impact of healthcare interventions on distress following acute musculoskeletal/orthopaedic injury: A scoping review of systematic reviews (2024) · cites this paper as [118]
Citations
Cites
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Core outcome measures for chronic pain clinical trials: IMMPACT recommendations
Dworkin, R. H., Turk, D. C., Farrar, J. T., Haythornthwaite, J. A., Jensen, M. P., Katz, N. P., Kerns, R. D., Stucki, G., Allen, R. R., Bellamy, N., et al. (2005) · Pain · doi:10.1016/j.pain.2004.09.012 · Cited by 3,732
Core outcome domains for chronic pain clinical trials: IMMPACT recommendations
Turk, D. C., Dworkin, R. H., Allen, R. R., Bellamy, N., Brandenburg, N., Carr, D. B., Cleeland, C., Dionne, R., Farrar, J. T., Galer, B. S., et al. (2003) · Pain · doi:10.1016/j.pain.2003.08.001 · Cited by 3,510
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The COMET Handbook: version 1.0
Williamson, P. R., Altman, D. G., Bagley, H., Barnes, K. L., Blazeby, J. M., Brookes, S. T., Clarke, M., Gargon, E., Gorst, S., Harman, N., et al. (2017) · Trials · doi:10.1186/s13063-017-1978-4 · Cited by 2,011
Developing core outcome sets for clinical trials: issues to consider
Williamson, P. R., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., & Tugwell, P. (2012) · Trials · doi:10.1186/1745-6215-13-132 · Cited by 1,661
Global Rating of Change Scales: A Review of Strengths and Weaknesses and Considerations for Design
Kamper, S. J., Maher, C. G., & Mackay, G. (2009) · Journal of Manual & Manipulative Therapy · doi:10.1179/jmt.2009.17.3.163 · Cited by 1,458
SF-36 total score as a single measure of health-related quality of life: Scoping review
Lins-Kusterer, L., & Carvalho, F. M. (2016) · SAGE Open Medicine · doi:10.1177/2050312116671725 · Cited by 1,258
Prinsen, C. A. C., Vohra, S., Rose, M. R., Boers, M., Tugwell, P., Clarke, M., Williamson, P. R., & Terwee, C. B. (2016) · Trials · doi:10.1186/s13063-016-1555-2 · Cited by 1,106
Core outcome measurement instruments for clinical trials in nonspecific low back pain
Chiarotto, A., Boers, M., Deyo, R. A., Buchbinder, R., Corbin, T. P., Costa, L. O. P., Foster, N. E., Grotle, M., Koes, B. W., Kovacs, F. M., et al. (2018) · Pain · doi:10.1097/j.pain.0000000000001117 · Cited by 461
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Sim, A., McNeilage, A. G., Gholamrezaei, A., Rebbeck, T., & Ashton-James, C. (2024) · BMJ Open · doi:10.1136/bmjopen-2024-085778 · Cited by 8
“The methodological strategy, including the publication of an a priori protocol and the use of two researchers to screen the reviews independently, enhances the rigour of this scoping review.”
MethodSelf-citation
Metadata
- Authors
- Sterling, M., Andersen, T., Carroll, L., Connelly, L., Côté, P., Curatolo, M., Grant, G., Jull, G., Kasch, H., Ravn, S. L., MacDermid, J., Malmström, E.-M., Rebbeck, T., Söderlund, A., Treleaven, J., Walton, D. M., & Westergren, H.
- Affiliations
- The University of Queensland (AU)
- University of Southern Denmark (DK)
- University of Alberta (CA)
- University of Toronto (CA)
- University of Washington (US)
- Aarhus University (DK)
- Western University (CA)
- Lund University (SE)
- The University of Sydney (AU)
- Mälardalen University (SE)
- Corresponding author
- Sterling, Michele
- ORCID
- Venue
- Pain
- Published
- 2023-05-10
- Volume
- 164
- Issue
- 10
- Pages
- 2265-2272
- ISSN
- 0304-3959 (ISSN-L)
- 1872-6623
- OpenAlex
- W4376226643
- Cited by
- 14
- References
- 37
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 5
- FWCI
- 2.17
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Topics
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Physical Sciences › Engineering › Biomedical Engineering › Automotive and Human Injury Biomechanics
- Keywords
- whiplash-associated disorders, core outcome set, patient-reported outcome measures, outcome reporting consistency, physical function, perceived recovery, psychological functioning, quality of life, pain intensity, work and social functioning, neck disability, pain catastrophizing
- MeSH terms
- Clinical Trials as Topic, Humans, Pain, Pain Measurement, Quality of Life, Whiplash Injuries, Treatment Outcome
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