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
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Delphi process
- 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.