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.
Contributors1. Alessandro Chiarotto - Vrije Universiteit & VU University Medical Center (Amsterdam, Netherlands)
2. Raymond W. Ostelo - Vrije Universiteit & VU University Medical Center (Amsterdam, Netherlands)
3. Maarten Boers - VU University Medical Center (Amsterdam, Netherlands)
4. Caroline B. Terwee - VU University Medical Center (Amsterdam, Netherlands)
5. Richard D. Deyo - Oregon Health and Science University (Portland, USA)
6. Rachelle Buchbinder - Monash University (Melbourne, Australia)
7. Terry P. Corbin - Cochrane Back & Neck Review Group (Maple Grove, USA)
8. Leonardo O.P. Costa - Universidade Cidade de Sao Paulo (Sao Paulo, Brazil)
9. Nadine E. Foster - Keele University (Keele, UK)
10. Margreth Grotle - Oslo University Hospital (Oslo, Norway)
11. Bart W. Koes - Erasmus University Medical Center (Rotterdam, Netherlands)
12. Francisco M. Kovacs - Spanish Back Pain Research Network (Madrid, Spain)
13. Chung-Wei C. Lin - University of Sydney (Sydney, Australia)
14. Chris G. Maher - University of Sydney (Sydney, Australia)
15. Adam M. Pearson - Darthmouth-Hitchcock Medical Center (Lebanon, USA)
16. Wilco C. Peul - Leiden University Medical Center (Leiden, Netherlands)
17. Mark L. Schoene - Cochrane Back & Neck Review Group (Newbury, USA)
18. Dennis C. Turk - University of Washington (Seattle, USA)
19. Maurits W. van Tulder - Vrije Universiteit (Amsterdam, Netherlands)
Disease Category: Orthopaedics & trauma
Disease Name: Low back pain
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Systematic review
The measurement properties of 17 patient-reported outcome measures for physical functioning, three for pain intensity, and five for HRQoL were appraised in three systematic reviews following COSMIN methodology. Researchers, clinicians and patients were invited in a two-round Delphi survey to generate consensus (defined as > 67% agreement) on which instruments to endorse for each domain. Considering all issues raised by Delphi participants, recommendations on core instruments were formulated by the steering committee overseeing this initiative.