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

Alessandro Chiarotto*, Maarten Boers, Richard A. Deyo, Rachelle Buchbinder, Terry P. Corbin, Leonardo O.P. Costa, Nadine E. Foster, Margreth Grotle, Bart W. Koes, Francisco M. Kovacs, C. W. Christine Lin, Chris G. Maher, Adam M. Pearson, Wilco C. Peul, Mark L. Schoene, Dennis C. Turk, Maurits W. Van Tulder, Caroline B. Terwee, Raymond W. Ostelo

*Corresponding author for this work

Research output: Contribution to JournalArticleAcademicpeer-review


To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary pane 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 5 207) 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 physica 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.

Original languageEnglish
Pages (from-to)481-495
Number of pages15
Issue number3
Early online date24 Nov 2017
Publication statusPublished - Mar 2018


R. Buchbinder, C.-W.C. Lin, and C.G. Maher are supported by Australian National Health and Medical Research Council (NHMRC) Research Fellowships. N.E. Foster is supported by a UK National Institute for Health Research (NIHR) Research Professorship (NIHR-RP-011-015). These funding bodies did not have any role in designing the study, in collecting, analysing and interpreting the data, in writing this manuscript, and in deciding to submit it for publication.

FundersFunder number
Australian National Health and Medical Research Council
National Institute for Health Research
National Health and Medical Research Council


    • Clinical trials
    • Core outcome set
    • Low back pain
    • Outcome measurement instruments
    • Recommendations


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