Li Geng, Zhou Li, Ouyang Wenwei, Xuan Meiling, Lu Liming, Li Xiaoyan, Wen Zehuai, Chen Xiankun
Mathematical Engineering Academy of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Trials. 2019 Jan 7;20(1):14. doi: 10.1186/s13063-018-3082-9.
Hyperlipidemia, defined as elevated lipid levels, is the primary and major risk factor for atherosclerotic cardiovascular disease. Several studies have evaluated the effects of Chinese medicine (CM) on hyperlipidemia. However, due to the varied designs and methods of these studies, data synthesis has been difficult, restricting the practical value of the findings. Developing a core outcome set (COS) could solve these methodological concerns. In this paper, we report a protocol to develop a COS for CM clinical trials for hyperlipidemia (COS-CM-Hyperlipidemia).
The development of COS-CM-Hyperlipidemia will include four stages: (1) a systematic review to identify potential important outcomes-a study advisory group, composed of core stakeholders of hyperlipidemia, will be set up afterwards to evaluate the identified outcomes and a candidate outcome set will be developed accordingly; (2) a panel of experts will be invited to conduct a three-round Delphi survey, so that the experts' opinions on the importance of outcomes for treating hyperlipidemia with CM will be collected; (3) a consensus meeting with clinicians, patients, and other key stakeholders will be conducted to finalize the items and definitions; and (4) COS-CM-Hyperlipidemia will be promoted and updated.
The development of this COS will improve the design and operation of CM trials on hyperlipidemia, keeping them in compliance with international standards, as well as the comparability and utility of their results.
The Core Outcome Measures in Effectiveness Trials Initiative (COMET): http://www.comet-initiative.org/studies/details/983 . Registered on 25 April 2017.
高脂血症定义为血脂水平升高，是动脉粥样硬化性心血管疾病的主要危险因素。多项研究评估了中药对高脂血症的影响。然而，由于这些研究的设计和方法各不相同，数据合成困难，限制了研究结果的实际应用价值。制定核心结局集（COS）可以解决这些方法学问题。在本文中，我们报告了一项针对高脂血症中药临床试验制定COS（COS-CM-高脂血症）的方案。
COS-CM-高脂血症的制定将包括四个阶段：（1）系统评价以确定潜在的重要结局——之后将成立一个由高脂血症核心利益相关者组成的研究咨询小组，对确定的结局进行评估，并据此制定候选结局集；（2）邀请专家小组进行三轮德尔菲调查，以收集专家对中药治疗高脂血症结局重要性的意见；（3）与临床医生、患者和其他关键利益相关者举行共识会议，以确定条目和定义；（4）推广和更新COS-CM-高脂血症。
该COS的制定将改善高脂血症中药试验的设计和操作，使其符合国际标准，以及结果的可比性和实用性。
有效性试验核心结局测量计划（COMET）：http://www.comet-initiative.org/studies/details/983 。于2017年4月25日注册。
