Cao Wen-Cong, Qiu Xing-Ying, Liu Bing-Qing, Li Geng, Wen Ze-Huai
Second Clinical College, Guangzhou University of CM, Guangzhou 510405, Guangdong Province, China.
Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of CM, Guangzhou 510120; State Key Laboratory of Dampness Syndrome of CM, Guangdong Provincial Hospital of CM, Guangzhou 510120.
Zhongguo Zhen Jiu. 2023 Sep 12;43(9):1086-93. doi: 10.13703/j.0255-2930.20220217-k0007.
To analyze the report status of outcomes and measurement instruments of randomized controlled trials (RCTs) of acupuncture for post-stroke dysphagia, so as to provide a basis for designing clinical trials and developing the core outcome set in acupuncture for post-stroke dysphagia.
RCTs of acupuncture for post-stroke dysphagia were searched in databases i.e. CNKI, SinoMed, Wanfang, PubMed, EMbase, Web of Science and clinical trial registries i.e. ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR), from January 1st, 2012 to October 30th, 2021. By literature screening and data extraction, outcomes and measurement instruments were summarized and analyzed.
A total of 172 trials (including 165 RCTs and 7 ongoing trials registrations) were included, involving 91 outcomes. The outcomes could be classified into 7 domains according to functional attributes, namely clinical manifestation, physical and chemical examination, quality of life, TCM symptoms/syndromes, long-term prognosis, safety assessment and economic evaluation. It was found that there were various measurements instruments with large differences, inconsistent measurement time point and without discriminatively reporting primary or secondary outcomes.
The status quo of outcomes and measurement instruments of RCTs of acupuncture for post-stroke dysphagia is not conducive to the summary and comparison of each trial's results. Thus, it is suggested to develop a core outcome set for acupuncture for post-stroke dysphagia to improve the normative and research quality of their clinical trial design.
分析针刺治疗中风后吞咽障碍随机对照试验（RCT）的结局报告状况及测量工具，为中风后吞咽障碍针刺临床试验设计及核心结局集的制定提供依据。
检索2012年1月1日至2021年10月30日期间中国知网、中国生物医学文献数据库、万方数据、PubMed、EMbase、Web of Science等数据库以及ClinicalTrials.gov和中国临床试验注册中心（ChiCTR）中的针刺治疗中风后吞咽障碍的RCT。通过文献筛选和数据提取，对结局及测量工具进行总结分析。
共纳入172项试验（包括165项RCT和7项正在注册的试验），涉及91个结局。根据功能属性，这些结局可分为7个领域，即临床表现、理化检查、生活质量、中医症状/证候、远期预后、安全性评估和经济学评价。发现测量工具多样，差异较大，测量时间点不一致，且未区分报告主要或次要结局。
针刺治疗中风后吞咽障碍RCT的结局及测量工具现状不利于各试验结果的总结和比较。因此，建议制定中风后吞咽障碍针刺的核心结局集，以提高其临床试验设计的规范性和研究质量。
