Core Outcome Measures in Effectiveness Trials

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

General Information

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.

Authors:
1. 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)

Publication

Journal:
Pain
Volume:
159
Issue:
3
Pages:
481 - 495
Year:
2018
DOI:
Further Study Information

Date:
August 2014 - August 2017
Funding source(s):
EUROSPINE Task Force Research (Grant number: EUROSPINE TFR 5-2015).

Health Area

Disease Category
Rehabilitation

Disease Name
Low back pain

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

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.


Stakeholders Involved

Clinical experts
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research
Recommended outcome measures (measurement)

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