目的总结上海交通大学医学院附属新华医院临床研究中心(Clinical Research Unit,CRU)平台成立以来的实践经验,为国内已经及正筹备建立临床研究中心平台的机构提供借鉴。方法该平台以医院需求为导向,搭建六大特色功能模块:项目管理、方...目的总结上海交通大学医学院附属新华医院临床研究中心(Clinical Research Unit,CRU)平台成立以来的实践经验,为国内已经及正筹备建立临床研究中心平台的机构提供借鉴。方法该平台以医院需求为导向,搭建六大特色功能模块:项目管理、方法学支撑、数据管理、质量风险管理、项目转化、以及培训及对外交流模块,建立并完善相应模块制度、质控、技术支撑及信息化数据平台体系等。结果在该平台支撑下,各临床专业、科室开展临床研究积极性不断增强,学科临床研究人才储备逐渐扩大;临床研究合作意识逐步提高,国际合作领域进一步拓展;临床研究项目数及获资助经费额度迅速增长。结论上海交通大学医学院附属新华医院临床研究中心平台为临床研究项目提供全方位技术支持和全过程信息化管理,提高临床研究项目质量和效率。借鉴国际先进理念的同时,仍需不断摸索完善符合我国大型综合性研究型医院特色的平台建设和管理模式,提升医院学术科研的国际竞争力。展开更多
Background Based on the excellent medical care and management system for Chinese veterans,as well as the detailed medical documentation available,we aim to construct a Chinese Veteran Clinical Research (CVCR) platfo...Background Based on the excellent medical care and management system for Chinese veterans,as well as the detailed medical documentation available,we aim to construct a Chinese Veteran Clinical Research (CVCR) platform on noncommunicable diseases (NCDs) and carry out studies of the primary disabling NCDs.Methods The Geriatric Neurology Department of Chinese People's Liberation Army General Hospital and veterans' hospitals serve as the leading and participating units in the platform construction.The fundamental constituents of the platform are veteran communities.Stratified typical cluster sampling is adopted to recruit veteran communities.A cross-sectional study of mental,neurological,and substance use (MNS) disorders are performed in two stages using screening scale such as the Mini-Mental State Examination and Montreal cognitive assessment,followed by systematic neuropsychological assessments to make clinical diagnoses,evaluated disease awareness and care situation.Results A total of 9 676 among 277 veteran communities from 18 cities are recruited into this platform,yielding a response rate of 83.86%.8 812 subjects complete the MNS subproject screening and total response rate is 91.70%.The average participant age is (82.01±4.61) years,69.47% of veterans are 80 years or older.Most participants are male (94.01%),83.36% of subjects have at least a junior high school degree.The overall health status of veterans is good and stable.The most common NCD are cardiovascular disorders (86.44%),urinary and genital diseases (73.14%),eye and ear problems (66.25%),endocrine (56.56%) and neuro-psychiatric disturbances (50.78%).Conclusion We first construct a veterans' comprehensive clinical research platform for the study of NCDs that is primarily composed of highly educated Chinese males of advanced age and utilize this platform to complete a cross-sectional national investigation of MNS disorders among veterans.The good and stable health condition of the veter展开更多
文摘目的总结上海交通大学医学院附属新华医院临床研究中心(Clinical Research Unit,CRU)平台成立以来的实践经验,为国内已经及正筹备建立临床研究中心平台的机构提供借鉴。方法该平台以医院需求为导向,搭建六大特色功能模块:项目管理、方法学支撑、数据管理、质量风险管理、项目转化、以及培训及对外交流模块,建立并完善相应模块制度、质控、技术支撑及信息化数据平台体系等。结果在该平台支撑下,各临床专业、科室开展临床研究积极性不断增强,学科临床研究人才储备逐渐扩大;临床研究合作意识逐步提高,国际合作领域进一步拓展;临床研究项目数及获资助经费额度迅速增长。结论上海交通大学医学院附属新华医院临床研究中心平台为临床研究项目提供全方位技术支持和全过程信息化管理,提高临床研究项目质量和效率。借鉴国际先进理念的同时,仍需不断摸索完善符合我国大型综合性研究型医院特色的平台建设和管理模式,提升医院学术科研的国际竞争力。
文摘Background Based on the excellent medical care and management system for Chinese veterans,as well as the detailed medical documentation available,we aim to construct a Chinese Veteran Clinical Research (CVCR) platform on noncommunicable diseases (NCDs) and carry out studies of the primary disabling NCDs.Methods The Geriatric Neurology Department of Chinese People's Liberation Army General Hospital and veterans' hospitals serve as the leading and participating units in the platform construction.The fundamental constituents of the platform are veteran communities.Stratified typical cluster sampling is adopted to recruit veteran communities.A cross-sectional study of mental,neurological,and substance use (MNS) disorders are performed in two stages using screening scale such as the Mini-Mental State Examination and Montreal cognitive assessment,followed by systematic neuropsychological assessments to make clinical diagnoses,evaluated disease awareness and care situation.Results A total of 9 676 among 277 veteran communities from 18 cities are recruited into this platform,yielding a response rate of 83.86%.8 812 subjects complete the MNS subproject screening and total response rate is 91.70%.The average participant age is (82.01±4.61) years,69.47% of veterans are 80 years or older.Most participants are male (94.01%),83.36% of subjects have at least a junior high school degree.The overall health status of veterans is good and stable.The most common NCD are cardiovascular disorders (86.44%),urinary and genital diseases (73.14%),eye and ear problems (66.25%),endocrine (56.56%) and neuro-psychiatric disturbances (50.78%).Conclusion We first construct a veterans' comprehensive clinical research platform for the study of NCDs that is primarily composed of highly educated Chinese males of advanced age and utilize this platform to complete a cross-sectional national investigation of MNS disorders among veterans.The good and stable health condition of the veter