Recommendations for a core outcome measurement set for clinical trials in whiplash associated disorders
(2023) In Pain 164(10). p.2265-2272- 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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2023-10-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Core outcomes, Patient-reported outcomes, Whiplash associated disorders
- in
- Pain
- volume
- 164
- issue
- 10
- pages
- 8 pages
- publisher
- Elsevier
- external identifiers
-
- pmid:37171189
- scopus:85171393801
- ISSN
- 0304-3959
- DOI
- 10.1097/j.pain.0000000000002926
- language
- English
- LU publication?
- yes
- additional info
- Publisher Copyright: © 2023 International Association for the Study of Pain.
- id
- c6aa440e-010e-42dd-8741-b4ae09e7136e
- date added to LUP
- 2023-12-07 15:47:36
- date last changed
- 2024-04-20 11:05:25
@article{c6aa440e-010e-42dd-8741-b4ae09e7136e,
abstract = {{<p>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.</p>}},
author = {{Sterling, Michele and Andersen, Tonny and Carroll, Linda and Connelly, Luke and Côté, Pierre and Curatolo, Michele and Grant, Genevieve and Jull, Gwendolen and Kasch, Helge and Ravn, Sophie Lykkegaard and MacDermid, Joy and Malmström, Eva Maj and Rebbeck, Trudy and Söderlund, Anne and Treleaven, Julia and Walton, David M. and Westergren, Hans}},
issn = {{0304-3959}},
keywords = {{Core outcomes; Patient-reported outcomes; Whiplash associated disorders}},
language = {{eng}},
month = {{10}},
number = {{10}},
pages = {{2265--2272}},
publisher = {{Elsevier}},
series = {{Pain}},
title = {{Recommendations for a core outcome measurement set for clinical trials in whiplash associated disorders}},
url = {{http://dx.doi.org/10.1097/j.pain.0000000000002926}},
doi = {{10.1097/j.pain.0000000000002926}},
volume = {{164}},
year = {{2023}},
}