Core Outcome Measures in Effectiveness Trials

Selecting measurement instruments for a core outcome set applicable to clinical trials in non-specific low back pain

General Information

Summary:
To standardize outcome reporting in clinical trials of patients with non-specific low back pain, international and multidisciplinary consensus was reached on a core outcome set including four domains: physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths (Chiarotto et al. 2015 Eur Spine J). Reporting the number of deaths is straightforward, but consensus on measurement instruments for the other three domains is needed. The current study aimed to reach consensus on instruments for these three domains.

Contributors:
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)

Further Study Information

Current Stage:
Ongoing
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)
Epidemiologists
Journal editors
Methodologists
Patient/ support group representatives
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.