• Alessandro Chiarotto, Maarten Boers, Richard A Deyo, Rachelle Buchbinder, Terry P Corbin, CostaLeonardo O PLOPMasters and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, Sao Paulo, Brazil., 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, and Raymond W Ostelo.
• Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, the Netherlands.
• Pain. 2018 Mar 1; 159 (3): 481495481-495.

AbstractTo 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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