Background: Chinese medicine (CM) is widely used for treating hyperlipidemias, especially in China. However, the heterogeneity of outcomes measured and reported across trials exacerbates the obstacles of evidence synthesis and effectiveness comparison. In this study, we develop a core outcome set (COS) for CM clinical trials for hyperlipidemia (COS-CM-Hyperlipidemia) to tackle the outcome issues.
Methods: We generated candidate outcomes through a systematic review of interventional and observational studies of Chinese medicine for hyperlipidemias. The comprehensive search strategy was employed. Study selection and data collection were independently done by two researchers. We searched clinical trial registry platform to supplement the outcomes list extracted by systematic review. Then, we conducted a three-round Delphi survey. The stakeholders were hyperlipidemia patients, clinicians or researchers, in either CM/integrated Chinese or Western medicine, clinical pharmacy, clinical epidemiology or statisticians, or editors of important relevant journals and an ethicist. They used a 9-point Likert scale to determine how important they felt each outcome was in determining treatment success. A consensus meeting was held to confirm the final COS, based on the Delphi survey results.
Results: We identified a total of 433 outcomes from 3,547 articles, and 28 outcomes from 367 registered trials. After standardization, we selected 71 outcomes to develop a preliminary outcome list for further consensus. After three Delphi survey rounds and one consensus meeting, the most important outcomes were determined for COS-CM-Hyperlipidemia. It included cardiovascular events, low-density lipoprotein cholesterol, risk of cardiovascular disease, total cholesterol, carotid intima-media thickness, high-density lipoprotein cholesterol, triglycerides, cerebrovascular events, adverse drug reactions and patient-reported symptoms.
Conclusion: COS-CM-Hyperlipidemia may improve outcome reporting consistency in clinical trials. Further work is needed to explore the optimal methods for measuring these outcomes.
Zehuai Wen is the principal investigator, Xiankun Chen, Geng Li, Li Zhou, Wenwei Ouyang, Meiling Xuan, Liming Lu, Xiaoyan Li, Xiaohui Guo
Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
Disease Category: Endocrine & metabolic
Disease Name: Hyperlipidemia
Age Range: 18 - 75
Sex: Either
Nature of Intervention: Traditional Chinese Medicine, Complementary and alternative medicine (CAM) therapy
- Clinical experts
- Consumers (patients)
- Ethicists
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
There will be five key stages to development of the COS: (1) Systematic review to identify currently reported outcomes in clinical trials of CM in hyperlipidemia. (2) Development of a panel of experts (3) Three-round Delphi survey to gain expert opinions (4) Consensus meeting to finalize the items and definitions (5) Promotion and update.