摘要
目的分析国内外护理质量临床试验特征,为我国护理质量临床试验管理提供参考。方法在ClinicalTrials.gov平台检索建库至2021年10月10日结局变量为护理质量的临床试验,分析纳入护理质量临床试验的注册时间、注册数量、试验地点、注册单位、资金来源、研究疾病、研究类型、样本量、研究状态及结果报告等信息。结果共获得142项护理质量临床试验。第一个护理质量临床试验注册于2001年,不同年份护理质量临床试验注册数量存在差异;试验地点以美洲和欧洲居多,注册单位以高等院校占比最高,资金来源分散;研究疾病分布广泛,主要包括肿瘤、糖尿病、精神分裂症、心肌梗死等;研究类型包括干预性研究和观察性研究,干预性研究占61.97%;样本量范围为8例~1000000例;85项试验处于已完成状态,仅11项试验报告结果。结论护理质量临床试验基本特征不均衡,内容特征呈现多元化,研究状态及结果报告有待完善。建议我国相关机构提供护理质量临床试验注册指导,规范护理质量临床试验数据管理,建立护理质量临床试验评价机制。
Objective To analyze the characteristics of clinical trial of nursing quality at home and abroad,and provide reference for clinical trial management of nursing quality.Methods The ClinicalTrials.gov platform was used to retrieve clinical trials from the establishment of the database to October 10,2021 whose outcome variable was nursing quality.The registration time,number of registrations,trial sites,registered units,funding sources,study diseases,study types,sample size,study status and results report of the included clinical trials on nursing quality were analyzed.Results A total of 142 clinical trials related to nursing quality were retrieved.The first clinical trial of nursing quality was registered in 2001,and there were differences in the number of clinical trials registered in different years.The study sites were mainly in America and Europe,the registered units were the highest in colleges and universities,and the sources of funds were dispersed.The studied diseases were widely distributed,including tumor,diabetes,schizophrenia,myocardial infarction,etc.The research types included intervention research and observational research,and intervention research accounted for 61.97%.The sample size ranged from 8 to 1000000 cases.85 trials were in the completed state and only 11 trials had reported results.Conclusion The basic features of clinical trials on nursing quality are not balanced,the content features are diversified,and the research status and results report need to be improved.It is suggested to provide registration guidance for clinical trials of nursing quality,standardize clinical trial data management of nursing quality,and establish evaluation mechanism of clinical trials of nursing quality.
作者
李玉培
乔建红
温慧
马帅
LI Yupei;QIAO Jianhong;WEN Hui(School of Nursing,Shandong First Medical University,Jinan,Shandong,250017,China)
出处
《中国卫生质量管理》
2023年第3期60-63,67,共5页
Chinese Health Quality Management
基金
中华护理学会科研课题(编号:ZHKY201904)。
关键词
护理质量
临床试验
注册
特征
Nursing Quality
Clinical Trials
Register
Characteristic
作者简介
通信作者:乔建红:山东第一医科大学第一附属医院门诊部主任,E-mail:1969144595@qq.com。
