Core Outcome Measures in Effectiveness Trials

Core outcome sets for back pain from China voice: Chinese experts' consensus based on the systematic review

General Information

Summary:
The inconsistent report of outcome indexes, measurements and the treatment response criteria has been shown among the clinical trials of Chronic back pain (CBP). Such problems failed the meta analyses in systematic review, leading to the low medical evidence. At abroad, the Core Outcome Sets (COS) of CBP (COS-CBP) are established to solve such problems. However, the foreign COS-CBP does not work to the TCM clinical studies of CBP, due to that the foreign COS-CBP cannot reflect the TCM characteristics in clinical studies, and that the COSs from foreign studies are inconsistent between each other, and the measurements recommended by the foreign COSs lack psychometric property in China. Besides, the COS-CBP that reflects the TCM characteristics in studies among Chinese population has not been established. Therefore, based on the methods and results from previous studies, this study aims to establish and optimize the COS-CBP and their Core Measurements Sets (CMS-CBP) for the TCM clinical study for CBP. The checklist of core outcomes and measurements was formed from the literature review, experts' recommendation and existing foreign COSs. The COS-CBP and CMS-CBP are established based on the checklists through the Delphi method and consensus meeting. After the establishment, the recommended measurements are tested and optimized in the clinical practice data. Along with the results of COS-CBP and CMS-CBP, the methodology of COS establishment for TCM is discussed and explored.

Contributors:
Changhe Yu as the principal investigator, Dongzhimen Hospital affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China

Further Study Information

Current Stage:
Ongoing
Date:
June 2019 - 2022
Funding source(s):
Project supported by the National Natural Science Foundation of China (Grant No. 81803956)

Health Area

Disease Category
Muscle disease
Orthopaedics & trauma

Disease Name
Low back pain

Target Population

Age Range
18 - 99

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Interview
Literature review
Systematic review

The checklists of core outcomes and measurements will be formed from the literature review, experts' recommendation and existing foreign COSs. The COS-CBP and CMS-CBP will be established based on the checklists through the Delphi method and consensus meeting. After the establishment, the recommended measurements will be tested and optimized with the clinical practice data.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Methodologists
Patient/ support group representatives
Regulatory agency representatives
Researchers
Service providers
Service users

Study Type

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

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