中国临床试验注册中心注册护理相关临床试验的特征分析

目的通过分析在中国临床试验注册中心(ChiCTR)注册的护理相关试验的特征,分析护理相关研究的设计类型、实施单位、资金来源和研究领域等特点。方法检索ChiCTR数据库中的护理相关临床试验,检索时限为建库至2020年5月25日。对注册护理相关试验的特征进行分析。结果共获得护理相关试验319项,其中268项试验的注册状态为预注册,51项为补注册。上海市、广东省、四川省、江苏省、北京市的试验注册数量≥25项。经费来源主要是院校资金,其次依次是地方财政、自筹和国家财政。注册的试验中,RCT有239项(74.92%),27项为多中心临床试验,有53项试验使用了盲法,277项试验通过了伦理委员会审查。研究领域分布广泛,主要为肿瘤、脑卒中和糖尿病等。结论ChiCTR注册护理相关试验的数量呈递增趋势,但研究分布存在地区不均衡性、高级别基金资助比例不高等情况,需要相关人员从护理教育、护理管理、研究登记管理和经费支持等多个方面提高护理的科研水平。

Characteristics of nursing-related clinical trials registered in Chinese Clinical Trial Registry

Objective To explore the characteristics of nursing-related research design types,implementation organizations,funding sources and research fields by analyzing the characteristics of nursing-related trials registered in the Chinese Clinical Trial Registry(ChiCTR).Methods We searched the nursing-related clinical trials registered in the ChiCTR database,and the search time was from the establishment of the database to May 25,2020.The characteristics of registered nursing related trials were analyzed.Results A total of 319 nursing-related trials were obtained,of which 268 trials were registered as pre-registration and 51 trials were supplementary registration.The number of trial registrations in Shanghai,Guangdong,Sichuan,Jiangsu and Beijing were greater than or equal to 25.The main source of funding was college funds,followed by local finance,self-financing and national finance.Among the registered trials,239(74.92%)were randomized controlled trials,and 27 were multi-center clinical trials,and 53 trials used the blind method,and 277 trials passed the review of the ethics committee.Research fields were widely distributed,mainly tumors,strokes and diabetes.Conclusions The number of nursing-related trials registered in ChiCTR is increasing,but there are regional imbalances in the distribution of research,and the low proportion of funding from high-level funds.Relevant personnel are needed to improve the level of nursing research from many aspects such as nursing education,nursing management,research registration management and funding support.