A core outcome set for clinical trials of Chinese Medicine in glucolipid metabolic disorders (GLMD)

Glucolipid metabolic disorders are closely intertwined with each other in pathophysiological mechanism, meanwhile, hyperglycemia, hyperlipidemia, hypertension, nonalcoholic fattyliver and atherosclerosis are often concurrent in clinical trials. Based on the holistic view of treating disease with Chinese medicine (CM), glucolipid metabolic disorders should be regarded as a whole to prevent and treat. Recently many clinical trials of CM are being conducted in Glucolipid metabolic disorders area. However, the heterogeneity of the results of many trials limits the quality of the trials and the integration of evidence, and also doesn’t effectively represent the holistic view of TCM. Therefore, developing the Core Outcome Set (COS) of Glucolipid metabolic disorders can effectively solve the problems mentioned above and improve the quality of clinical trials of CM.

Contributors

Guo Jiao, Institute of Chinese Medicine, Guangdong Pharmaceutical University, Guangzhou, China (Principal investigator)
Huang Xiaoqiang, Science and Technology Innovation Center, Guangzhou University of Chinese Medicine, Guangzhou, China
Piao Shenghua, Institute of Chinese Medicine, Guangdong Pharmaceutical University, Guangzhou, China
Rong Xianglu Institute of Chinese Medicine, Guangdong Pharmaceutical University, Guangzhou, China
Jin Yinghua, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China
Zhan Huixia, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China

Further Study Information

Current Stage: Ongoing
Date: October 2021 - June 2023
Funding source(s): This work is supported by Key Project of National Natural Science Foundation of China (81830113); National key R&D plan "Research on modernization of traditional Chinese medicine" (2018YFC1704200) and Major basic and applied basic research projects of Guangdong Province of China (2019B030302005).


Health Area

Disease Category: Endocrine & metabolic

Disease Name: Glucolipid metabolic disorders

Target Population

Age Range: 18 - 90

Sex: Either

Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (patients)
- Epidemiologists
- Ethicists
- Researchers
- Statisticians

Study Type

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

Method(s)

- Consensus conference
- Delphi process
- Interview
- Literature review
- Semi structured discussion

This study will conduct mixed method research for COS development:
(1) literature review to clearify currently reported outcomes in clinical trials of CM in GLMD.
(2) Two or Three-round Delphi survey and consensus conference to gain expert opinions and reach consensus.
(3) Mixed method research to finalize the items and definition.
(5) Promotion and update.

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