Design Study Of TCM Health Log Subsystem For Cognitive Impairment After Stroke

ObjectiveTo develop and design the health log electronic data capture subsystem of patients with post-stroke cognitive impairment,according to the international relevant laws and regulations of clinical trial and Good Clinical Practice.The health log subsystem have four modules:entering,browsing,modifying and downloading the health log data,the system have the functions of medical coding,authority management,modifying records and data query.Through using the data capture system to both ensure data quality and improve efficiency.Therefore,the subsystem improves the degree of electronization and normalization of Traditional Chinese Medicine clinical data.MethodsThrough searching and sorting a large number of related literature,being familiar with the domestic and international clinical data management law and regulations,industry standards,summarizing the domestic and international application status of clinical data management systems.Combining the clinical data features of Traditional Chinese Medicine clinic,stroke,post-stroke cognitive impairment and the situations of this study,using interviewing method and researching the subject materials,investigating and analyzing the system requirements with user-centered principles.This research conducts system analysis and design by using structure system development methodology,according to the system design plan,applying SQL Server 2008 database,based on HTML language,Java Script source code of ASP(Active Server Page)programming technology,based on Browser/Server architecture,develop and design the health log subsystem of the clinical data management system of the prevention and treatment of Traditional Chinese Medicine in post-stroke cognitive impairment.Using simulate data carry on system testing of the health log subsystem,combining the actual running interface,demonstrate a detailed example application.ResultsThe Special Research Project of TCM 2010 "the technology transformation and promotion of community study in the prevention of stroke with Traditional Chinese Medicine-the community prevention of post-stroke cognitive impairment with Traditional Chinese Medicine and management study",there were 14 hospitals that distributed over different regions participated,enrolled 3000 cases,except capturing the data of general information,laboratory data,scales etc.It is necessary to capture the health log data.This study have developed the two health log subsystem of the studies of "the hierarchical control mode of prevention of community Traditional Chinese Medicine in post-stroke cognitive impairment"and "the integrated intervention program with Traditional Chinese Medicine in post-stroke mild cognitive impairment".The health log handbook were divided into intervention group and non-intervention group,conducting health education and health promotion for intervention group,conducting health education for non-intervention group.The health log subsystem have provided four modules:entering health log data,browsing health log data,modifying health log data and downloading health log data.The health log subsystem have achieved user authority management,data modifying records,automatic verification of key fields,data query and data export functions,the system have met data capture,query and management requirements.The health log subsystem have accomplished the electronic collection of the 24 weeks health log data of enrolled cases,a total of tens of thousands of records.It has increased the efficiency of data capture and data management,and it has provided the electronic and normalized data for further statistical analysis of related study.This research has met the requirements of data quality in clinical research.ConclusionThe current clinical data management system cannot meet the personalized clinical research needs,therefore,there is a need for develop the clinical data capture system of some special departments,special diseases.As research continues in some diseases,the requirements of data capture in clinical research varied greatly,therefore,it will cause the difficulties of development and maintenance of related clinical data management.If each of clinical studies developing and applying the software that only adapt to each issue,it will has significant rework.This system improves the degree of electronization and normalization of Traditional Chinese Medicine clinical data in a certain extent.This study can be used for reference in the electronic capture and standardized management of chronic disease data.However,it still has many aspects that need to improve,for instance,export data with single format,not provided statistical analysis functions and the design functions of templates of electronic case report form.The further study should build and apply multi-project sharing,and a platformization clinical data management system.