《真实世界针灸临床研究数据管理规范》的编制与解读

Compilation and Interpretation of Guidelines of Data Management Specification in Clinical Trials of Acupuncture and Moxibustion in the Real World

随着中医药标准化进程的不断加快和由于真实世界临床研究理念的影响,越来越多的研究者重视从真实世界获得数据,以解决医学问题。针灸临床试验由于实施盲法存在一定困难,使得随机对照研究并不好开展,因而越来越多地转向真实世界研究。真实世界数据主要来源于医院信息系统数据、登记研究数据、医保支付数据等多个数据源,相较于“金标准”随机对照试验(Randomized Controlled Trial,RCT),真实世界数据在大多数情况下缺乏记录、采集、存储等流程的研究质量控制,数据质量问题严重影响了临床研究结果的可靠性。数据管理是提高数据质量的重要途径,故《真实世界针灸临床研究数据管理规范》的诞生对于真实世界针灸临床研究的规范性具有重要意义。因此,通过详述该规范的编制原则、方法、过程及具体内容和在编制中的思考过程,希望帮助读者深刻理解该规范的内容,将该规范应用于数据管理实践,提高研究数据质量。

With the continuous acceleration of the standardization process of traditional Chinese medicine(TCM)and the influence of the concept of real-world clinical research,an increasing number of researchers are paying attention to obtaining data from the real world to address medical problems.Due to the difficulty of implementing blinding in acupuncture and moxibustion clinical trials,conducting randomized controlled trials(RCTs)is not always feasible,leading to a growing shift towards real-world research.Real-world data primarily come from various sources such as hospital information systems,registry studies,and medical insurance payment data.In comparison to RCTs with“gold standard”,real-world data often lack research quality control processes such as recording,collection,and storage,which significantly affects the reliability of clinical research results.Data management is an important approach to improving data quality.Hence,the establishment of the Guidelines of Data Management Specification in Clinical Trials of Acupuncture and Moxibustion in the Real World is of great significance for standardizing real-world acupuncture and moxibustion clinical research.Therefore,by elaborating on the principles,methods,processes,specific contents,and considerations during the development of these guidelines,this study hopes to help readers gain a thorough understanding of the contents and apply these guidelines to data management practices to enhance the quality of research data.