| Objective:To explore the big data concept and the application of TCM information standards to standardize and effectively deal with the digital technology and methods of TCM electronic medical records,so as to provide high-quality digital data resources for the innovative development of TCM theory and clinical practice.The standard operating procedures for the digitalization of TCM electronic medical records were formulated to provide a systematic and standardized basis and guidance for the digitalization of TCM electronic medical records clinical data.Methods: Research on the digital standard operating procedure of TCM electronic medical record data was carried out by means of literature research,field research,group discussion and empirical research.The literature research method is used to extensively collect and comb the relevant data standards and indicators,as well as the design requirements of relevant documents on standard operating procedures.Then,combing the work process with the methods of field research and group discussion,the specific content of each stage is clarified to form a set of standard operating procedures.A questionnaire was designed to consult experts in the fields of traditional Chinese medicine,clinical practice and statistics,classify and summarize their opinions,and then revise the standard operating procedure of digital electronic medical records of traditional Chinese medicine according to their opinions,and form the standard operating procedure of digital electronic medical records of traditional Chinese medicine.Finally,the feasibility and practical value of the standardoperating procedure are verified by empirical research.Results:(1)completed the design of the expert consultation questionnaire for constructing the digital standard operating process of electronic medical records of traditional Chinese medicine,including the questionnaire for general information of experts,expert opinions on the stage division and division of standard operating process,expert judgment basis and the questionnaire for the degree of familiarity with the research issues.Based on the data obtained from the questionnaire survey conducted among 32 relevant experts,according to the statistical index calculation method consulted by Delphi experts,the expert judgment basis is 0.70,the expert familiarity is 0.95,and the expert authority is 0.83.(2)completed the design of standard operating procedure(SOP)for digital electronic medical records of traditional Chinese medicine.The standard operation process of TCM electronic medical record digitization is divided into five stages: organization and management stage,data stage,digital stage,thematic stage and summary stage.The objectives,specific operation contents and methods of each stage are clearly defined.(3)designed the TCM clinical research data sheet(CDF),and coded the TCM clinical electronic medical record data according to the TCM information classification and code standard,and filled them in according to the(CDF)format to form a digital TCM clinical research data sheet.(4)explore the application methods and approaches of TCM information standards in the digitization of TCM electronicmedical records,and promote the application of TCM information standards.Conclusion:Based on the innovative design of big data concept,the standard operating process specification for digital electronic medical records of traditional Chinese medicine(TCM)defines it as "organization management,data,digitization,theme,and summary",forming an organically connected digital standard operating process system for TCM electronic medical records.The feasibility and practical value of the operation process are verified by the empirical study of the process.It can guarantee the digital quality of TCM electronic medical record data and provide abundant data resources for TCM clinical data analysis and mining based on big data technology.At the same time,it also promotes the clinical application of TCM information standards,ensures the interactive sharing of TCM clinical data,and becomes an example of the clinical application of TCM data standards. |