基于中国临床试验注册中心的干预性护理研究现状分析

Current situation of interventional nursing research in China based on Chinese Clinical Trial Registry

  • 摘要:
    目的 分析基于中国临床试验注册中心(ChiCTR)的干预性护理研究现状。
    方法 检索ChiCTR自建库至2024年5月31日注册的所有干预性护理研究,纳入并提取注册研究的相关信息。
    结果 共纳入护理干预性研究462项,其中预注册365项,补注册97项。2020年及以后注册项目占总注册数的83.33%, 注册数目居前3位的地区分别为上海市(56项)、广东省(50项)、北京市(49项)。注册数量≥5个的单位合计12个,其中四川大学华西医院注册数达18项。所有项目中自筹经费为160项(34.63%), 多中心合作研究为48项(10.39%)。随机平行对照试验为322项, 其中有281项(87.27%)对随机化有进一步描述, 167项(51.86%)对盲法有进一步描述。研究对象为护理人员的注册项目为94项,主要集中在护理教学、心理健康、职业倦怠、压力和睡眠研究领域。研究对象为患者或临床问题的注册项目为368项,主要集中在康复护理、生活质量、自我管理和营养管理研究领域。
    结论 中国干预性护理研究注册数量在ChiCTR平台逐年上升,但注册地区、经费分布不均,合作性项目数量较少,不利于多学科优势的整合与发挥。此外,随机化和盲法应用不规范,注册信息不全,核心研究热点领域有待进一步拓展和完善。建议从组织注册培训、加强护理研究设计培训等方面入手,进一步提高护理科研水平。

     

    Abstract:
    Objective To analyze the current status of interventional nursing studies registered in the Chinese Clinical Trial Registry (ChiCTR).
    Methods All intervention nursing studies registered in the ChiCTR self-establishment database from May 31, 2024 were retrieved, and relevant information of the registered studies was included and extracted.
    Results A total of 462 nursing intervention studies were included, among which 365 were pre-registered and 97 were supplementary registered. The number of registered items in 2020 and beyond accounted for 83.33% of the total number of registrations. Currently, the top three regions in terms of the number of registrations were Shanghai (56 items), Guangdong Province (50 items) and Beijing (49 items). A total of 12 units had registration number of ≥5, among which West China Hospital of Sichuan University had 18 registrations. Among all the projects, 160 were self-funded (34.63%), and 48 were multi-center cooperative research (10.39%). There were 322 randomized parallel controlled trials, among which 281(87.27%) provided further descriptions of randomization and 167(51.86%) provided further descriptions of blinding. The registered items for the research subjects of nursing staff were 94, mainly concentrated in the research fields such as nursing teaching, mental health, job burnout, stress and sleep. There were 368 registered items whose research subjects were patients or clinical problems, mainly concentrated in research fields such as rehabilitation nursing, quality of life, self-management and nutrition management.
    Conclusion The number of registrations of interventional nursing research in China on the ChiCTR platform has been increasing year by year. However, the registration regions and the distribution of funds are uneven, and the number of cooperative projects is relatively small, which is not conducive to the integration and exertion of multidisciplinary advantages. In addition, the application of randomization and blinding is not standardized, the registration information is incomplete, and the core research hotspots need to be further expanded and improved. It is suggested to start from aspects such as organizing registration training and strengthening the training of nursing research design to further improve the level of nursing scientific research.

     

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