Developing a Core Outcome Set for Clinical Trials of Chinese Medicine for Hyperlipidemia

• DOI: 10.3389/fphar.2022.847101
• Publication Date: 2022-05-02T05:29:50Z
• Authors: Geng Li; Ruxue Han; Mingjun Lin; Zehuai Wen; Xiankun Chen
• Keywords: Hyperlipidemia; Delphi Method

Background: Chinese medicine (CM) is widely used for treating hyperlipidemias, especially in China. However, the heterogeneity of outcomes measured and reported across trials exacerbates obstacles evidence synthesis effectiveness comparison. In this study, we develop a core outcome set (COS) CM clinical hyperlipidemia (COS-CM-Hyperlipidemia) to tackle issues. Methods: We generated candidate through systematic review interventional observational studies hyperlipidemias. The comprehensive search strategy was employed. Study selection data collection were independently done by two researchers. searched trial registry platform supplement list extracted review. Then, conducted three-round Delphi survey. stakeholders patients, clinicians or researchers, either CM/integrated Western medicine, pharmacy, epidemiology statisticians, editors important relevant journals an ethicist. They 9-point Likert scale determine how they felt each determining treatment success. A consensus meeting held confirm final COS, based on survey results. Results: identified total 433 from 3,547 articles, 28 367 registered trials. After standardization, selected 71 preliminary further consensus. three rounds one meeting, most determined COS-CM-Hyperlipidemia. It included cardiovascular events, low-density lipoprotein cholesterol, risk disease, carotid intima-media thickness, high-density triglycerides, cerebrovascular adverse drug reactions patient-reported symptoms. Conclusion: COS-CM-Hyperlipidemia may improve reporting consistency Further work needed explore optimal methods measuring these outcomes. Registration: Core Outcome Measures Effectiveness Trials Initiative (COMET): http://www.cometinitiative.org/studies/details/983. Registered 25 April 2017.