基于ClinicalTrials.gov的护理质量临床试验特征分析
发布人：yaot 发布时间：2023/4/13 14:55:01 浏览次数：732次
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】——李玉培 乔建红 温 慧 马 帅
【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～1 000 000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。
【关键词】护理质量；临床试验；注册；特征
中图分类号：R47文献标识码：A
Characteristics Analysis of Clinical Trials on Nursing Quality Based on ClinicalTrials.gov/LI Yupei,QIAO Jianhong,WEN Hui,et al.//Chinese Health Quality Management，2023,30(3):60-63,67
Abstract 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 1 000 000 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.
Key words Nursing Quality；Clinical Trials; Register; Characteristic
Firstauthor's address School of Nursing, Shandong First Medical University, Jinan, Shandong, 250017, China
护理质量指护士为患者提供护理技术和专业服务的效果和程度，主要包括护理结构、护理过程和护理结局三部分［1］，与患者预后、学科发展及医院社会形象等密切相关［2-3］。护理质量临床试验是以人为对象的前瞻性研究，是指预先将受试者分配接受一种或多种干预措施，并评价干预措施对患者健康结局的影响，从而为护理临床决策提供高质量证据。ClinicalTrials.gov平台［4］由美国国立医学图书馆及美国食品与药物管理局于1997年开发,是目前国际上重要的临床试验注册机构之一。其目的在于向患者、医疗卫生人员和社会大众提供临床试验信息查询服务，向医学科研人员和机构提供临床试验注册服务。通过分析已注册的临床试验，可以了解某一领域的研究进展情况［5-8］。本研究通过检索ClinicalTrials.gov平台的护理质量临床试验，多角度描述护理质量临床试验特征，以期为我国护理质量临床试验管理提供借鉴。
1资料与方法
1.1资料来源
登录ClinicalTrials.gov（https://clinicaltrials.gov/）平台，检索与护理质量相关的临床试验，检索字段选择 “condition or disease”，检索词为“quality of care”“nursing quality”“quality of nursing”“care quality”，检索时间为建库至2021年10月10日。
1.2纳入与排除标准
纳入标准：临床试验结局指标为护理质量。排除标准：重复注册及非护士主导的临床试验。由双人根据纳入与排除标准筛选检索到的护理质量临床试验，若无法达成统一意见，则由第三人判断。
1.3资料提取
提取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。
1.4统计分析方法
利用Microsoft Excel 2010软件录入数据，使用频数和百分比进行描述性分析。
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