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Cited by 461Musculoskeletal pain and rehabilitationDelphi Technique in ResearchMedical Practices and Rehabilitation

The DOI matches its Crossref record; 108 of the 109 references it cites were found in a registry or an index.

Core outcome measurement instruments for clinical trials in nonspecific low back pain

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Chiarotto, Alessandro, Boers, Maarten, Deyo, Richard A., Buchbinder, Rachelle, Corbin, Terry P., Costa, Leonardo O.P., Foster, Nadine E., Grotle, Margreth, Koes, Bart W., Kovacs, Francisco M., Lin, C.-W. Christine, Maher, Chris G., Pearson, Adam M., Peul, Wilco C., Schoene, Mark L., Turk, Dennis C., van Tulder, Maurits W., Terwee, Caroline B., Ostelo, Raymond W.·2018·Pain
DOI 10.1097/j.pain.0000000000001117PMC PMC5828378
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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.

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Crossref · 10.1097/j.pain.0000000000001117

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Figure 1. Flowchart of participants in the Delphi study on core outcome measurement instruments for clinical trials in nonspecific low back pain (LBP).
Figure 1. Flowchart of participants in the Delphi study on core outcome measurement instruments for clinical trials in nonspecific low back pain (LBP).CC BY-NC-ND · PubMed Central
Figure 2. Delphi endorsement of 9 physical functioning tools as core outcome measurement instruments for clinical trials in nonspecific low back pain (round 1).
Figure 2. Delphi endorsement of 9 physical functioning tools as core outcome measurement instruments for clinical trials in nonspecific low back pain (round 1).CC BY-NC-ND · PubMed Central
Figure 3. Delphi endorsement of 3 pain intensity tools as core outcome measurement instruments for clinical trials in nonspecific low back pain (round 1).
Figure 3. Delphi endorsement of 3 pain intensity tools as core outcome measurement instruments for clinical trials in nonspecific low back pain (round 1).CC BY-NC-ND · PubMed Central
Figure 4. Delphi endorsement of 4 health-related tools as core outcome measurement instruments for clinical trials in nonspecific low back pain (round 1 and round 2).
Figure 4. Delphi endorsement of 4 health-related tools as core outcome measurement instruments for clinical trials in nonspecific low back pain (round 1 and round 2).CC BY-NC-ND · PubMed Central

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Research works printed but not linked: 1

  1. Mokkink, 2017, COSMIN checklist 2.0 for assessing the methodological quality of studies on the measurement properties of Paitent-Reported Outcome Measures, Qual Life Res

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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
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2017-11-24
Volume
159
Issue
3
Pages
481-495
ISSN
  • 0304-3959 (ISSN-L)
  • 1872-6623
DOI
10.1097/j.pain.0000000000001117
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
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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