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, 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

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.

Conflict of interest statement

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Figures

Figure 1.
Figure 1.
Flowchart of participants in the Delphi study on core outcome measurement instruments for clinical trials in nonspecific low back pain (LBP).
Figure 2.
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 3.
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 4.
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).

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Source: PubMed

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