Wang Juan, Cheng Chung Wah, Jiao Yalin, Shi Dongni, Wang Yaochen, Li Han, Wang Nana, Wang Xihong, Li Yuqin, Liang Feng, Luo Shufeng, Han Fei, Li Ji, Wang Ping, Lyu Aiping, Bian Zhaoxiang, Zhang Xuan
Chinese EQUATOR Centre, Hong Kong Baptist University, Hong Kong SAR, China.
School of Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Front Pharmacol. 2024 Feb 23;15:1287262. doi: 10.3389/fphar.2024.1287262. eCollection 2024.
The CONSORT Extension for Chinese Herbal Medicine Formula 2017 (CONSORT-CHM Formula 2017) has established a reporting standard for randomized controlled trials (RCTs) of Chinese Herbal Medicine Formula (CHMF) interventions; however, its adherence and implications for the design and execution of study design remain ambiguous. It is necessary to evaluate the level of compliance with the CONSORT-CHM Formula 2017 in RCTs conducted over the past 5 years, and to determine the reporting quality of clinical trials in this field. First, a systematic search is conducted for RCTs on CHMF in EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid-MEDLINE(R), Wanfang data, China National Knowledge Infrastructure (CNKI), VIP Chinese Medical Journal Database (VIP) and Chinese Biomedical Literature (CBM) database, that encompassed CHMF interventional RCTs published from 1 January 2018 to 8 June 2022, with language restriction to English or Chinese. Second, a descriptive analysis will be performed regarding the study design and general characteristics of the included trials. Third, for the quality assessment, we have subdivided the CONSORT-CHM Formula 2017 checklist (consisting of 22 extended items) into a total of 42 sub-questions to facilitate scoring, with a specific focus on the description, quality control, and safety assessment of CHMF interventions. Professional training and a pilot test on 100 randomly selected articles will be provided for all reviewers. Throughout this process, a standard operating procedure (SOP) for quality assessment will be developed to ensure consistency. Each item will be assessed by two reviewers in a paired back-to-back manner, and the compliance rate will be calculated to assess inter-rater agreement. This review will identify the current reporting characteristics and quality of CHMF interventional studies and further evaluate the impact of CONSORT-CHM Formula 2017. The results may provide suggestions for future application or promotion of the guideline. Registration: The study has been registered on Open Science Framework (https://osf.io/xpn7f).
《2017年中药复方随机对照试验CONSORT扩展声明》(CONSORT-CHM Formula 2017)已为中药复方(CHMF)干预的随机对照试验(RCT)制定了报告标准;然而,其对研究设计和实施的依从性及影响仍不明确。有必要评估过去5年进行的RCT中对CONSORT-CHM Formula 2017的遵守程度,并确定该领域临床试验的报告质量。首先,在循证医学评价数据库、联合与补充医学数据库(AMED)、Embase、Ovid-MEDLINE(R)、万方数据、中国知网(CNKI)、维普中文科技期刊数据库(VIP)和中国生物医学文献数据库(CBM)中对CHMF的RCT进行系统检索,纳入2018年1月1日至2022年6月8日发表的CHMF干预性RCT,语言限制为英文或中文。其次,将对纳入试验的研究设计和一般特征进行描述性分析。第三,在质量评估方面,我们将CONSORT-CHM Formula 2017清单(由22个扩展项目组成)细分为总共42个问题以方便评分,特别关注CHMF干预的描述、质量控制和安全性评估。将为所有评审人员提供专业培训并对100篇随机选择的文章进行预测试。在整个过程中,将制定质量评估的标准操作程序(SOP)以确保一致性。每个项目将由两名评审人员以背对背配对的方式进行评估,并计算符合率以评估评分者间的一致性。本综述将确定CHMF干预性研究的当前报告特征和质量,并进一步评估CONSORT-CHM Formula 2017的影响。研究结果可能为该指南未来的应用或推广提供建议。注册情况:该研究已在开放科学框架(https://osf.io/xpn7f)上注册。