Core Outcome Measures in Effectiveness Trials

A core outcome set of gout treatment in traditional Chinese medicine

General Information

Summary:
Objectives: This study aimed to reach consensus on the COS of core outcome set of gout treatment in traditional Chinese medicine.

Methods: A steering group of researchers and clinicians will guide the COS development. 6 stakeholder groups are involved: patients, Traditional Chinese medicine doctor, physician, nurses, research worker and drug regulatory authorities. A 1:1 ratio of patients: healthcare professionals are aimed for. The initial list of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) gout patients who have received TCM treatment and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 3 anonymous online Delphi rounds are then planned together with 1 face-to-face consensus meetings.

Discussion: A COS in this field has the potential to allow fast-tracking recommendations for application in research and clinical practice.

Contributors:
Ming Liu, Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University;
Ya Gao,Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University;
Yuan Yuan,Gansu University of Chinese Medicine;
Junhua Zhang,Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine;
Jinhui Tian,Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University.

Further Study Information

Current Stage:
Ongoing
Date:
December 2019 - June 2021
Funding source(s):
None

Health Area

Disease Category
Rheumatology

Disease Name
Gout

Target Population

Age Range
18 - 120

Sex
Either


Nature / type of Intervention
Traditional Chinese Medicine

Method(s)

Consensus conference
Consensus meeting
Delphi process
Focus group(s)
Interview
Literature review
Survey
Systematic review

(1) Bulid the COS pool:a systematic review of the literature, gout patients who have received TCM treatment and an online healthcare professional (HCP) item generation survey;
(2) 3 anonymous online Delphi rounds;
(3) face-to-face consensus meetings.


Stakeholders Involved

Clinical experts
Conference participants
Consumers (patients)
Families
Journal editors
Methodologists
Patient/ support group representatives
Policy makers
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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