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Core outcome-domains for clinical trials in non-specific low back pain
Open accessAbstract
PURPOSE: Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP. METHODS: An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions. RESULTS: A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45%. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: 'physical functioning', 'pain intensity' and 'health-related quality of life'. Consensus on 'physical functioning' and 'pain intensity' was consistent across all stakeholders, 'health-related quality of life' was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain 'number of deaths'. CONCLUSIONS: The following outcome domains were included in this updated COS: 'physical functioning', 'pain intensity', 'health-related quality of life' and 'number of deaths'. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.
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“Compared to other recommendations (e.g. IMMPACT 37,38 , on low back pain 5 ) VAPAIN has produced some different results.”
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Metadata
- Authors
- Chiarotto, A., Deyo, R. A., Terwee, C. B., Boers, M., 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., & Ostelo, R. W.
- Affiliations
- Amsterdam Public Health (NL)
- Oregon Health & Science University (US)
- Monash University (AU)
- The University of Sydney (AU)
- Arthritis Research UK (GB)
- Oslo University Hospital (NO)
- Erasmus MC (NL)
- Fundación Kovacs (ES)
- Dartmouth–Hitchcock Medical Center (US)
- Leiden University Medical Center (NL)
- University of Washington (US)
- Corresponding author
- Chiarotto, Alessandro
- ORCID
- Venue
- European Spine Journal
- Published
- 2015-04-05
- Volume
- 24
- Issue
- 6
- Pages
- 1127-1142
- ISSN
- 0940-6719 (ISSN-L)
- 1432-0932
- OpenAlex
- W2047189877
- Cited by
- 374
- References
- 47
- Citations by year
- 2026: 15 · 2025: 34 · 2024: 52 · 2023: 33 · 2022: 33 · 2021: 31 · 2020: 38 · 2019: 49 · 2018: 32 · 2017: 27 · 2016: 21 · 2015: 7
- FWCI
- 97.10
- Type
- journal article
- Language
- en
- Update notices
- correction (2015-05-08)
- Open access
- hybrid
- doi.org
- Locations
- European Spine Journal (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
- VU Research Portal (publishedVersion, other-oa)
- Keele Research Repository (Keele University) (submittedVersion, cc-by)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, cc-by)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Leiden Repository (Leiden University) (submittedVersion)
- NORA - Norwegian Open Research Archives (submittedVersion, cc-by)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- RePub (Erasmus University Rotterdam) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Topics
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- non-specific low back pain, core outcome set, outcome reporting, physical function, pain intensity, health-related quality of life, Delphi consensus, stakeholder consensus, clinical trial results
- MeSH terms
- Clinical Trials as Topic, Delphi Technique, Female, Humans, Male, Low Back Pain, Patient Outcome Assessment
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