TY - JOUR
T1 - Core outcome measurement instruments for clinical trials in nonspecific low back pain
AU - Chiarotto, Alessandro
AU - Boers, Maarten
AU - Deyo, Richard A.
AU - Buchbinder, Rachelle
AU - Corbin, Terry P.
AU - Costa, Leonardo O.P.
AU - Foster, Nadine E.
AU - Grotle, Margreth
AU - Koes, Bart W.
AU - Kovacs, Francisco M.
AU - Christine Lin, C. W.
AU - Maher, Chris G.
AU - Pearson, Adam M.
AU - Peul, Wilco C.
AU - Schoene, Mark L.
AU - Turk, Dennis C.
AU - Van Tulder, Maurits W.
AU - Terwee, Caroline B.
AU - Ostelo, Raymond W.
N1 - Publisher Copyright:
Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND)
PY - 2018/3
Y1 - 2018/3
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Core outcome set
KW - Low back pain
KW - Outcome measurement instruments
KW - Recommendations
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U2 - 10.1097/j.pain.0000000000001117
DO - 10.1097/j.pain.0000000000001117
M3 - Article
C2 - 29194127
AN - SCOPUS:85048403026
SN - 0304-3959
VL - 159
SP - 481
EP - 495
JO - Pain
JF - Pain
IS - 3
ER -