ABSTRACT
This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.
ABSTRACT
Objective To study the scientificity and rationality in data management of the project of Chinese Chronic Disease Clinical Research System and its Achievements Application Mode;To provide evidence and reference for the improvement of follow-up work. Methods According to the relevant management regulations, guidelines, and other relevant documents of national and international clinical research data,“Questionnaire for Research Data Management Assessment of Chinese Chronic Disease Prevention” was designed. The questionnaires were used in 10 clinical topics during the on-site inspection survey, and 20 valid questionnaires were retrieved and analyzed statistically. Results 50-60 percentage of subjects in data management and statistics were performed by the third party;70 percentage of subjects were performed by their own central monitoring;50 percentage of the subjects adopted a cooperative manner with others to develop appropriate data management systems;7 centers had system and plan for data management;Data management was carried out;implementation degree of training, database, CRF tracing, and others 7 aspects was low. Conclusion Improving the quality of data management of TCM clinical research still needs to be perfected from many aspects, and quality mode of large-scale clinical trials should be improved.
ABSTRACT
Biological, psychological and sociological model of medicine substantializes the old model lacking the social humane attributes. The new medical model makes people take medical anthropology into research and highly evaluate traditional medical system. Cultural anthropology of traditional Chinese medicine (TCM) is part of medical anthropology with three major characteristics: wide research scope, specificity, and integration. It has developed its own research methods, such as field investigation, comprehensive inspection and comparison study. Cultural anthropology provides an efficient research method for TCM, and its application would further develop TCM theory and form comprehensive evaluation on TCM effects.
ABSTRACT
Abstract: There are two stages for selecting the clinical intervention outcome variables. One is crude collection and the other is precise collection. The selection methods include brainstorming method, Delphi method, Gordon method, systematic review, systematic analysis method, mathematic model method and so on. Each method has some advantages or disadvantages. When selecting the clinical intervention outcome variables, researchers should make sure the research aim, the representative and the sensitivity of the variables, and select all kinds of recommended methods comprehensively, then decide which method should be used.
ABSTRACT
Effect of clinical intervention on human body is multistage and multifaceted, involving physiology, psychology, social function and the surrounding resources, etc. Therefore, the range of clinical outcome assessment includes patient, his or her family and care giver. The evaluation of clinical intervention mainly focuses on its effectiveness, safety and health economics. Effects of clinical interventions are measured by comparisons of the outcome of intervention and control groups. Different effect measures come from different comparisons.