摘要目的 了解临床医生的科研水平和薄弱环节,有针对性的开展临床研究系统培训,加强其对临床资源与数据的利用,促进科研成果转化.方法 通过网络和微信软件,将电子版问卷链接下发给上海某高校附属13家医院的临床医生进行填写和上报.结果 共收到有效问卷507份:临床医生在试验方案设计、PICO要素制定、随机化和盲法的设置、统计分析方案设计、试验管理、规范撰写等较薄弱;最希望接受培训的内容是方案设计与撰写、临床研究方法学和统计学应用.结论 按CONSORT声明和SPIRIT规范设计和撰写临床试验方案,以及流行病学和统计学方法的应用仍是大多数医生亟待提高的短板,同时也是他们最为关心的内容,接受临床研究系统培训提升科研能力显得十分必要.

abstractsObjective Through investigating the clinicians’ scientific research level and weakness,we can carry out targeted clinical research training systematically,and then strengthen their utilization of clinical resources and data,and finally promote the transformation of scientific research resuits.Methods Filling and submitting the online questionnaires through WeChat,a popular chatting tool in China,physicians from 13 affiliated hospitals of a university in Shanghai have joined this research.Results 507 valid questionnaires have been received online:In terms of clinical research capacity,there seemed to be more barriers in the following issues:comprehension of the types and applications to design a clinical trial,formulation of the details including PICO elements(Patient-Intervention-Comparison-Outcome),methodological application including the category and principle of randomization,the category and principle of blind method and how to control the confounding elements and probable bias,and statistical problems in scientific research including discrimination of the different definition between FAS(Full Analysis Set) based on the principle of ITT(Intention-To-Treat) and PPS(Per-Protocol Set),how to write a standardized SAP(Statistical Analysis Plan) and how to calculate the sample size of a trial),and various management of clinical trials including data management,follow-up management,adverse event management and so on,and writing a protocol and a CRF (Case Report Form) in a standard and professional way.As for the needs for training,the top three topics were how to design a clinical research in a standardized style,how to practice the methodology and how to utilize the statistical skills into clinical trials.Conclusions Standardized design and writing of clinical trial protocols according to the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items:Recommendations for Interventional Trials),and the application of epidemiological and statistical methods are still short boards that most clinicians need to improve urgently,also are what they most concerned about at the same time.So it is necessary for physicians to receive systematic clinical research training to enhance their scientific research capacity.