Outcome Measures for Low Back Pain Research: A Proposal for Standardized Use

Deyo, Richard A.; Battie, Michele; Beurskens, A. J. H. M.; Bombardier, Claire; Croft, Peter; Koes, Bart; Malmivaara, Antti; Roland, Martin; Von Korff, Michael; Waddell, Gordon

doi:10.1097/00007632-199809150-00018

Cited by 1,229Musculoskeletal pain and rehabilitationSpine and Intervertebral Disc PathologyMedical Practices and Rehabilitation

Outcome Measures for Low Back Pain Research: A Proposal for Standardized Use

Deyo, Richard A., Battie, Michele, Beurskens, A. J. H. M., Bombardier, Claire, Croft, Peter, Koes, Bart, Malmivaara, Antti, Roland, Martin +2 more·1998·Spine

DOI 10.1097/00007632-199809150-00018

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Abstract

STUDY DESIGN: An international group of back pain researchers considered recommendations for standardized measures in clinical outcomes research in patients with back pain. OBJECTIVES: To promote more standardization of outcome measurement in clinical trials and other types of outcomes research, including meta-analyses, cost-effectiveness analyses, and multicenter studies. SUMMARY OF BACKGROUND DATA: Better standardization of outcome measurement would facilitate comparison of results among studies, and more complete reporting of relevant outcomes. Because back pain is rarely fatal or completely cured, outcome assessment is complex and involves multiple dimensions. These include symptoms, function, general well-being, work disability, and satisfaction with care. METHODS: The panel considered several factors in recommending a standard battery of outcome measures. These included reliability, validity, responsiveness, and practicality of the measures. In addition, compatibility with widely used and promoted batteries such, as the American Academy of Orthopaedic Surgeons Lumbar Cluster were considered to minimize the need for changes when these instruments are used. RESULTS: First, a six-item set was proposed, which is sufficiently brief that it could be used in routine care settings for quality improvement and for research purposes. An expanded outcome set, which would provide more precise measurement for research purposes, includes measures of severity and frequency of symptoms, either the Roland or the Oswestry Disability Scale, either the SF-12 or the EuroQol measure of general health status, a question about satisfaction with symptoms, three types of "disability days," and an optional single item on overall satisfaction with medical care. CONCLUSION: Standardized measurement of outcomes would facilitate scientific advances in clinical care. A short, 6-item questionnaire and a somewhat expanded, more precise battery of questionnaires can be recommended. Although many considerations support such recommendations, more data on responsiveness and the minimally important change in scores are needed for most of the instruments.

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The minimal clinically important change of RMDQ is 3.
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The secondary outcome measures were selected based on core outcome sets recommended for LBP.
“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”
From Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial (2019) · cites this paper as [40]

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Authors: Deyo, R. A., Battie, M., Beurskens, A. J. H. M., Bombardier, C., Croft, P., Koes, B., Malmivaara, A., Roland, M., Von Korff, M., & Waddell, G.
Affiliations: University of Washington (US)
University of Manchester (GB)
Group Health Cooperative (US)
Keele University (GB)
Amsterdam Public Health (NL)
University of Alberta (CA)
Corresponding author: Deyo, Richard A.
ORCID: Beurskens, A. J. H. M.
Bombardier, Claire
Croft, Peter
Koes, Bart
Roland, Martin
Venue: Spine
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 1998-09
Volume: 23
Issue: 18
Pages: 2003-2013
ISSN: 0362-2436 (ISSN-L)
DOI: 10.1097/00007632-199809150-00018
OpenAlex: W2145513209
Cited by: 1,229
References: 17
Citations by year: 2026: 13 · 2025: 15 · 2024: 18 · 2023: 29 · 2022: 24 · 2021: 29 · 2020: 48 · 2019: 45 · 2018: 31 · 2017: 44 · 2016: 52 · 2015: 67 · 2014: 58 · 2013: 62 · 2012: 70
FWCI: 15.61
Type: journal article
Language: en
Open access: closed
Locations: Spine (publishedVersion)
PubMed (publishedVersion)
EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
Funders: Agency for Healthcare Research and Quality (HS 08194)
Topics: Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
Health Sciences › Medicine › Pathology and Forensic Medicine › Spine and Intervertebral Disc Pathology
Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Medical Practices and Rehabilitation
Keywords: low back pain, outcome measures, clinical trials, work disability, disability days, health-related quality of life, patient satisfaction, symptom severity, Oswestry Disability Index, SF-12, EuroQol, minimally important change, responsiveness
MeSH terms: Clinical Trials as Topic, Health Status Indicators, Humans, Quality of Life, Surveys and Questionnaires, Research, Outcome Assessment, Health Care, Low Back Pain

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Outcome Measures for Low Back Pain Research: A Proposal for Standardized Use

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