关键词: 临床研究设计, 报告声明, 结果研究, 数据库系统, 标准作业程序, 精准医学

Abstract:

Standard and rule of clinical research of surgery                 YANG  Zhen.Department of Surgery, Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology,Wuhan430030,China
Abstract    In order to enhance the level and quality of clinical research of chinese surgery,the design, implementation, supervision and reporting of clinical research should follow the international standard and rule. It is included that (1) Chinese medical journals should adopt the checklist and the flow diagram of reporting statements, ensuring the quality of reporting of studies of surgical literature. (2) Assessment of the level of evidences and grades of recommendation of reporting of clinical research according to the Oxford and GRADE system in order to improve the quality of clinical research results and reporting of systematic reviews and meta-analyses.(3) Applications with database management system provides a very useful framework for clinical research of surgery. (4)Implementation of clinical research methodologically should follow the standard operation procedure.(5) Medical statistic are very important during the whole course of clinical research, including the research design, data collection and analysis of results, etc.(6)The precision medicine conducted in China need improvement and collaboration with evidence-based medicine in order to meet the need of clinical research of surgery.

Key words: clinical study design, statement for reporting, outcome research, database systems, standard operation procedure, precision medicine