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Core outcome measurement instruments for clinical trials in nonspecific low back pain
Open accessAbstract
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.
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In the citing paper
“The secondary outcome measures selected were those that had the potential to be primary or secondary outcomes of a potential full clinical trial, based on the core outcome sets recommended for LBP.39 40”
In the citing paper
“outcomes were consistent with NIH recommendations on research standards for chronic LBP38 and core outcome sets for LBP research39”
In the citing paper
“Nevertheless, we recognise that current tools specific for back pain or musculoskeletal conditions are scarce for assessing health related quality of life.30 124”
From Psychological interventions for chronic, non-specific low back pain: systematic review with network meta-analysis (2022) · cites this paper as [30]
In the citing paper
“To improve measurement standardization, the international consortium overseeing the core set initiative for LBP decided to recommend the SF-12 and the PROMIS-GH-10 for HRQoL, as they both provide PCS and MCS scores, and the PROMIS-GH-10 represents a free of charge option [26].”
From Evidence on the measurement properties of health-related quality of life instruments is largely missing in patients with low back pain: A systematic review (2018) · cites this paper as [26]
In the citing paper
“On the other hand, the SF-36 was not endorsed because it was considered too long for inclusion in every clinical trial, and the EQ-5D because it provided scores that cannot be pooled with the other instruments' scores (i.e., SF12 and PROMIS-GH-10) [26].”
From Evidence on the measurement properties of health-related quality of life instruments is largely missing in patients with low back pain: A systematic review (2018) · cites this paper as [26]
In the citing paper
“The results of this systematic review informed an international and multidisciplinary Delphi process to endorse core instruments for LBP clinical trials; however, none of the HRQoL instruments met the prespecified 67% cutoff for consensus (although the SF-12 came close) [26].”
From Evidence on the measurement properties of health-related quality of life instruments is largely missing in patients with low back pain: A systematic review (2018) · cites this paper as [26]
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Metadata
- Authors
- 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., Lin, C.-W. C., Maher, C. G., Pearson, A. M., Peul, W. C., Schoene, M. L., Turk, D. C., van Tulder, M. W., Terwee, C. B., & Ostelo, R. W.
- Affiliations
- Amsterdam Public Health (NL)
- Oregon Health & Science University (US)
- Cabrini Hospital (AU)
- Cochrane Canada (CA)
- Universidade Cidade de São Paulo (BR)
- Arthritis Research UK (GB)
- Oslo University Hospital (NO)
- Erasmus MC (NL)
- Spanish Back Pain Research Network, Hospital Universitario HLA-Moncloa, Madrid, Spain
- The University of Sydney (AU)
- Sydney School of Public Health, Sydney Medical School, University of Sydney, Sydney, Australia
- Dartmouth–Hitchcock Medical Center (US)
- Leiden University Medical Center (NL)
- Cochrane Collaboration, Back and Neck Review Group, Newbury, MA, USA
- University of Washington (US)
- Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences Research Institute, Vrije Universiteit, Amsterdam, the Netherlands
- Corresponding author
- Chiarotto, Alessandro
- ORCID
- Venue
- Pain
- Published
- 2017-11-24
- Volume
- 159
- Issue
- 3
- Pages
- 481-495
- ISSN
- 0304-3959 (ISSN-L)
- 1872-6623
- PMC
- PMC5828378
- OpenAlex
- W2768831605
- Cited by
- 461
- References
- 109
- Citations by year
- 2026: 46 · 2025: 56 · 2024: 61 · 2023: 59 · 2022: 59 · 2021: 66 · 2020: 55 · 2019: 38 · 2018: 17 · 2017: 1
- FWCI
- 21.20
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Pain (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
- VU Research Portal (publishedVersion, other-oa)
- Leiden Repository (Leiden University) (submittedVersion)
- Keele Research Repository (Keele University) (submittedVersion, cc-by)
- Monash University Research Portal (Monash University) (submittedVersion, cc-by-nc-nd)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, cc-by-nc-nd)
- RePub (Erasmus University Rotterdam) (submittedVersion, cc-by-nc-nd)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0515-10095, NIHR-RP-011-015)
- EUROSPINE (EUROSPINE TFR 5-2015)
- 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
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Medical Practices and Rehabilitation
- Keywords
- non-specific low back pain, core outcome measures, patient-reported outcome measures, physical function, pain intensity, health-related quality of life, measurement properties, Oswestry Disability Index, Roland-Morris Disability Questionnaire, numerical rating scale, SF-12, PROMIS Global Health, Delphi consensus
- MeSH terms
- Adult, Clinical Trials as Topic, Delphi Technique, Disability Evaluation, Female, Humans, Male, Middle Aged, Pain Measurement, Quality of Life, Reproducibility of Results, Treatment Outcome, Outcome Assessment, Health Care, Low Back Pain
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