Preliminarily Constructing Core Outcome Sets (COS) for the clinical evaluation on the Traditional Chinese Medicine Dietotherapy (TCM-D) for patients with type 2 diabetes based on evidence-based medicine

The outcomes of clinical research on TCM-D are scattered. Consequently, it has been inconducive to compare or analyses those outcomes. The application value of TCM-D outcomes has been invisibly reduced as well. Developing and applying a minimum outcome set that has been standardized and agreed to be reported, i.e., the Core Outcome Set (COS), can effectively solve the problems mentioned above and is of great significance for exploring the advantages of TCM-D. This study aims to build a dual-system COS of integrated Chinese and Western medicine in the clinical research of TCM-D by taking type 2 diabetes (called XiaoKe in TCM) as an example.

Contributors

Yanju LI 1*, Dongyu MU 1, Jie GONG 1, Ziqi ZHOU 1, Yu XUE 1, Xile JIANG 1, Lei SHI 1, Yuan LIU 1, Yi CHENG 1, Wen HU 1**

1. Department of Clinical Nutrition, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China
* the principal investigator
** the principal supervisors

Further Study Information

Current Stage: Ongoing
Date: May 2020 - May 2022
Funding source(s): (1) National Natural Science Foundation of China (7167030309). (2) State Administration for Market Regulation (SAMR) commissioned project (ZX2020001)


Health Area

Disease Category: Endocrine & metabolic

Disease Name: Type 2 Diabetes

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Patient/ support group representatives

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Literature review
- Survey
- Systematic review

This COS will be developed following principles outlined by Core Outcome Set-STAndardised Protocol Items (COS-STAP) and Core Outcome Set-Standards for Development (COS-STAD) guidelines. Three phases in this COS study will be as follows:
(1) Generate a list of relevant outcomes and reporting items identified from a systematic review (SR). The information sources of the SR are mainly from (a) published studies, (b) textbook and (c) stakeholder qualitative interviews. Identified outcomes and items will be categorized via a conceptual framework based on syndrome differentiation of TCM and western medicine,and formatted into the 1st round of Delphi survey questionnaire items.
(2) Perform at least two consecutive rounds of Delphi surveys among stakeholders invited by the working group of Core Outcome sets and Core Outcome measurement sets in NUTriology (COCONUT) to create the COS for future clinical trials of XiaoKe (diabetes mellitus). COCONUT will invite patients, clinical dietitians, physicians (traditional Chinese medicine physicians and western physicians), COS researchers and journal editors to score each reporting item and outcome from the aspects of clinical importance, stability and feasibility.
(3) Hold a face-to-face consensus meeting to refine the content of the COS. Key stakeholders will be invited to attend the consensus meeting to discuss and agree the final content of the and COS(s).

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