Qiu Ruijin, Li Min, Zhang Xiaoyu, Chen Shiqi, Li Chengyu, Shang Hongcai
Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.
Trials. 2018 Oct 5;19(1):541. doi: 10.1186/s13063-018-2904-0.
An increasing number of clinical trials of traditional Chinese medicine are being conducted in the treatment of non-valvular atrial fibrillation (NVAF) in China. However, the heterogeneity of outcomes and outcome measurement instruments has produced little evidence for traditional Chinese medicine in treating NVAF because many trials cannot be included in a meta-analysis. The majority of the trials did not report endpoint outcomes, side effects or other important outcomes for patients, which makes it difficult to evaluate the efficacy and safety of traditional Chinese medicine. Therefore, it is important to develop a core outcome set (COS). Although there are two related COSs for clinical trials of atrial fibrillation, the methodology is limited, and the perspectives of Chinese experts and patients are unclear. Therefore, we will develop a COS and recommend outcome measurement instruments after finishing the COS, which can be used for clinical trials of traditional Chinese medicine in NVAF.
METHODS/DESIGN: The method of the study will include eight stages led by a national multidisciplinary Steering Committee: (1) A systematic review will be developed to identify currently reported outcomes and traditional Chinese medicine syndromes in clinical trials of NVAF, (2) Semi-structured interviews of patients will be conducted to fill gaps in potential outcomes, (3) Traditional Chinese medicine syndrome names will be identified from medical records, (4) A dataset of traditional Chinese medicine syndrome names will be developed, (5) The investigation of traditional Chinese medicine syndromes will be conducted from cross-sectional study, (6) Two rounds of Delphi surveys will be carried out, (7) A consensus meeting will be conducted to develop a COS, and (8) Recommendations of outcome measurement instruments (OMIs), which should be used in the COS, will be developed.
The COS will improve the consistency of outcome reporting and reduce the reporting bias in NVAF clinical trials of traditional Chinese medicine to improve the value of traditional Chinese medicine clinical trials.
This study is not a clinical trial, so it is registered in Core Outcome Measures in Effectiveness Trials Initiative (COMET). Registration number: 941 . Registered on 22 December 2016.
在中国，越来越多的中药临床试验正在用于治疗非瓣膜性心房颤动（NVAF）。然而，由于许多试验无法纳入荟萃分析，结果的异质性和结果测量工具导致几乎没有证据支持中药治疗NVAF。大多数试验未报告终点结局、副作用或患者的其他重要结局，这使得难以评估中药的疗效和安全性。因此，制定核心结局集（COS）很重要。虽然有两个与心房颤动临床试验相关的COS，但方法有限，中国专家和患者的观点也不明确。因此，我们将制定一个COS，并在完成COS后推荐结局测量工具，可用于NVAF的中药临床试验。
方法/设计：该研究方法将包括由国家多学科指导委员会牵头的八个阶段：（1）开展系统评价，以确定NVAF临床试验中目前报告的结局和中医证候，（2）对患者进行半结构化访谈，以填补潜在结局的空白，（3）从病历中识别中医证候名称，（4）建立中医证候名称数据集，（5）通过横断面研究对中医证候进行调查，（6）进行两轮德尔菲调查，（7）召开共识会议以制定COS，（8）制定应在COS中使用的结局测量工具（OMIs）的推荐意见。
COS将提高结局报告的一致性，减少中药NVAF临床试验中的报告偏倚，以提高中药临床试验的价值。
本研究不是临床试验，因此在有效性试验核心结局指标倡议（COMET）中注册。注册号：941。于2016年12月22日注册。
