摘要
肝胆恶性肿瘤治疗的特点是多种治疗手段、多个学科协同。为评价不同治疗措施或联合治疗方案的临床疗效, 推动肝胆恶性肿瘤综合治疗规范化开展, 笔者单位依托医院信息化平台搭建肝胆肿瘤患者登记与随访数据库, 用于指导临床医师做出科学决策, 提高临床诊断与治疗水平。该研究阐述了肝胆肿瘤数据库的构架设计、功能模块、数据采集流程与质量控制措施等。采用观察性双向队列研究设计, 一方面对既往病例资料进行数据整理使之与现行数据库相匹配, 另一方面前瞻性收集后续的临床数据, 包括患者基本信息、入院评估、手术信息与术后情况、综合治疗措施、定期复查结果、长期随访结局等。通过制订标准化操作流程、人员规范化培训、全流程数据管理计划等措施完善数据质量控制体系。该数据库将为临床医师、研究者、指南制订专家提供高质量的真实世界数据, 进而为肝胆恶性肿瘤综合治疗的规范化开展提供高级别循证医学证据。
The treatment of hepatobiliary malignant tumor is characterized by the coexistence of multiple treatment methods and multiple disciplines.In order to evaluate the clinical efficacy of different treatment measures or multiple treatment combinations,and to promote the standardized development of comprehensive treatment patterns for hepatobiliary malignant tumor,the Hepatobiliary Center of the First Affiliated Hospital of Nanjing Medical University constructs the registry and follow-up database in hepatobiliary tumor patients based on the information-based platform of the hospital,which will help guide clinicians to make scientific decisions and improve the level of clinical diagnosis and treatment.This study describes the framework design,function modules,data acquisition process and quality control of the database of hepatobiliary malignant tumor.Based on the observational bidirectional cohort study design,the previous clinical data can be sorted to match the current database,on the other hand,the clinical data can be prospectively collected including basic information,admission evaluation,surgical information and postoperative situation,comprehensive treatment measures,regular reexaminations and long-term follow-up,etc.The data quality control system can be improved by formulating standardized operation procedures,regularly personnel training and full-process data management plans.This database will provide high-quality real-world data for clinicians,researchers,and guideline experts,and then provide high-level medical evidence for the standardized development of comprehensive treatment patterns of hepatobiliary malignancies.
作者
张慧
焦臣宇
朱甬倩
李长贤
夏永祥
李相成
王学浩
赵杨
刘晋
Zhang Hui;Jiao Chenyu;Zhu Yongqian;Li Changxian;Xia Yongxiang;Li Xiangcheng;Wang Xuehao;Zhao Yang;Liu Jin(Department of Hepatobiliary Center,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China;Department of Information Division,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China;Department of Biostatistics,School of Public Health,Nanjing Medical University,Nanjing 211166,China;Clinical Medicine Research Institution,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China)
出处
《中华消化外科杂志》
CAS
CSCD
北大核心
2022年第2期307-312,共6页
Chinese Journal of Digestive Surgery
基金
国家自然科学基金(81602938)。
关键词
肝肿瘤
胆道肿瘤
双向队列研究
数据质量控制
数据库
Liver neoplasms
Biliary tract neoplasms
Bidirectional cohort study
Quality control
Database
