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 re-al 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 pay-ment data.In comparison to RCTs with"gold standard",real-world data often lack research quality control processes such as re-cording,collection,and storage,which significantly affects the reliability of clinical research results.Data management is an impor-tant 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 moxi-bustion clinical research.Therefore,by elaborating on the principles,methods,processes,specific contents,and considerations dur-ing 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.
关键词
真实世界/针灸/临床研究/数据管理/规范编制/标准化/解读/数据质量
Key words
Real world/Acupuncture and moxibustion/Clinical research/Data management/Preparation of specifications/Standardization/Interpretation/Data quality
维普
万方数据