Li Geng, Han Ruxue, Lin Mingjun, Wen Zehuai, Chen Xiankun
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Front Pharmacol. 2022 May 2;13:847101. doi: 10.3389/fphar.2022.847101. eCollection 2022.
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. 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. 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. COS-CM-Hyperlipidemia may improve outcome reporting consistency in clinical trials. Further work is needed to explore the optimal methods for measuring these outcomes. The Core Outcome Measures in Effectiveness Trials Initiative (COMET): http://www.cometinitiative.org/studies/details/983. Registered on 25 April 2017.
中药在中国广泛用于治疗高脂血症。然而，各试验中测量和报告的结果存在异质性，这加剧了证据综合和疗效比较的障碍。在本研究中，我们制定了一个用于高脂血症中药临床试验的核心结局集（COS-CM-高脂血症），以解决结局问题。我们通过对中药治疗高脂血症的干预性和观察性研究进行系统评价，生成了候选结局。采用了全面的检索策略。研究筛选和数据收集由两名研究人员独立完成。我们检索了临床试验注册平台，以补充系统评价提取的结局列表。然后，我们进行了三轮德尔菲调查。利益相关者包括高脂血症患者、中医/中西医结合的临床医生或研究人员、临床药师、临床流行病学家或统计学家、重要相关期刊的编辑以及一名伦理学家。他们使用9点李克特量表来确定他们认为每个结局在确定治疗成功方面的重要程度。根据德尔菲调查结果，召开了一次共识会议以确认最终的核心结局集。我们从3547篇文章中总共确定了433个结局，从367项注册试验中确定了28个结局。标准化后，我们选择了71个结局来制定初步结局列表以进行进一步的共识。经过三轮德尔菲调查和一次共识会议，确定了COS-CM-高脂血症最重要的结局。它包括心血管事件、低密度脂蛋白胆固醇、心血管疾病风险、总胆固醇、颈动脉内膜中层厚度、高密度脂蛋白胆固醇、甘油三酯、脑血管事件、药物不良反应以及患者报告的症状。COS-CM-高脂血症可能会提高临床试验中结局报告的一致性。需要进一步开展工作来探索测量这些结局的最佳方法。有效性试验核心结局测量计划（COMET）：http://www.cometinitiative.org/studies/details/983。于2017年4月25日注册。
