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

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

Pain (Amsterdam), 2018-03, Vol.159 (3), p.481-495 [Periódico revisado por pares]

United States: Wolters Kluwer

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Título:
Core outcome measurement instruments for clinical trials in nonspecific low back pain
Autor: 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
Assuntos: Adult ; Clinical Trials as Topic - methods ; Delphi Technique ; Disability Evaluation ; Female ; Humans ; Low Back Pain - psychology ; Low Back Pain - therapy ; Male ; Middle Aged ; Outcome Assessment, Health Care - methods ; Pain Measurement ; Quality of Life ; Reproducibility of Results ; Research Paper ; Treatment Outcome
É parte de: Pain (Amsterdam), 2018-03, Vol.159 (3), p.481-495
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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Descrição: 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.
Editor: United States: Wolters Kluwer
Idioma: Inglês

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

United States: Wolters Kluwer

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