Chiarotto, A, Boers, M, Deyo, RA, Buchbinder, R, Corbin, TP, Costa, LOP, Foster, NE ORCID: 0000-0003-4429-9756, Grotle, M, Koes, BW, Kovacs, FM, Lin, C-WC, Maher, CG, Pearson, AM, Peul, WC, Schoene, ML, Turk, DC, van Tulder, MW, Terwee, CB and Ostelo, RW (2018) Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain, 159 (3). pp. 481-495. ISSN 1872-6623

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Abstract

To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Item Type: Article
Additional Information: This is the accepted author manuscript (AAM). The final published version (version of record) is available online via Wolters Kluwer at http://dx.doi.org/10.1097/j.pain.0000000000001117 - please refer to any applicable terms of use of the publisher.
Uncontrolled Keywords: Core outcome set, Recommendations, Outcome measurement instruments, Low back pain, Clinical trials
Subjects: R Medicine > R Medicine (General)
R Medicine > RC Internal medicine > RC925 Diseases of the musculoskeletal system
Divisions: Faculty of Medicine and Health Sciences > Primary Care Health Sciences
Related URLs:
Depositing User: Symplectic
Date Deposited: 09 Feb 2018 09:43
Last Modified: 05 Jul 2018 12:14
URI: http://eprints.keele.ac.uk/id/eprint/4436

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