Zhang Ting, Li Xuechao, Zhao Liang, Zhang Jiaoyan, Tian Jinhui, Zhang Junhua
Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Clinical Research Center, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, China.
Front Med (Lausanne). 2022 Mar 3;9:753138. doi: 10.3389/fmed.2022.753138. eCollection 2022.
Stroke, an acute cerebrovascular disease, is mainly caused by the sudden rupture or occlusion of blood vessels, and is subdivided into ischemic stroke and hemorrhagic stroke. It has become the second leading cause of death worldwide. In Chinese clinical practice, traditional Chinese medicine (TCM)/Integrative Medicine has been widely used for the treatment of stroke. Numerous randomized controlled trials (RCTs) of TCM/Integrative Medicine for stroke have been conducted to improve the efficacy and safety outcomes. However, their conclusions should be treated with caution because of the methodological quality defects in the clinical research. Pervasive inconsistencies are present in the outcomes collected and reported across these studies, which may lead to the pooling of discrepant data and preclude meta-analysis. The issue could be addressed by developing a core outcome set (COS).
The aim of this study is to develop a COS in the clinical trials of TCM/Integrative Medicine in the treatment of stroke.
A steering group will be set up to organize and guide the development of the COS. The study contains three phases: (I) development of an initial outcome list covering all relevant outcomes, two steps: (i) systematic reviews of outcomes for clinical trials of TCM/ Integrative Medicine for stroke; (ii) semi-structured interviews with patients suffering from stroke; (II) conduction of three round of Delphi surveys with different stakeholder groups to prioritize important outcomes; (III) integration of outcomes into a core outcome set by a consensus meeting.
This study has been granted by the Ethics Committee of Tianjin University of Traditional Chinese Medicine (TJUTCM-EC20210003). When the COS is completed, we will publish it in an appropriate journal to promote further widespread use.
This study has been registered at the Core Outcome Measures in Effectiveness Trials initiative, COMET database (Registration #1678).
中风是一种急性脑血管疾病，主要由血管突然破裂或阻塞引起，可细分为缺血性中风和出血性中风。它已成为全球第二大死因。在中国临床实践中，中医/中西医结合已广泛用于中风治疗。为提高疗效和安全性结果，已开展了大量中医/中西医结合治疗中风的随机对照试验（RCT）。然而，由于临床研究方法学质量缺陷，其结论应谨慎对待。这些研究收集和报告的结果普遍存在不一致性，这可能导致差异数据的汇总并妨碍荟萃分析。可通过制定核心结局集（COS）来解决这一问题。
本研究旨在制定中医/中西医结合治疗中风临床试验的核心结局集。
将成立一个指导小组来组织和指导核心结局集的制定。该研究包括三个阶段：（I）制定涵盖所有相关结局的初始结局清单，分两步：（i）对中医/中西医结合治疗中风的临床试验结局进行系统评价；（ii）对中风患者进行半结构化访谈；（II）对不同利益相关者群体进行三轮德尔菲调查，以确定重要结局的优先级；（III）通过共识会议将结局整合为核心结局集。
本研究已获得天津中医药大学伦理委员会批准（TJUTCM-EC20210003）。核心结局集完成后，我们将在合适的期刊上发表，以促进其进一步广泛应用。
本研究已在有效性试验核心结局指标倡议组织（COMET）数据库注册（注册号#1678）。
