中国临床试验注册中心在册安宁疗护研究特征分析及其报告质量评价

Characteristics and report quality of palliative care studies registered in ChiCTR

目的:分析我国临床试验注册中心(ChiCTR)在册安宁疗护的研究特征,并对其报告质量进行评价。方法:检索在ChiCTR注册的安宁疗护相关研究,检索时限为建库至2024年1月13日。由2名研究者独立筛选研究并提取相关信息,采用世界卫生组织国际临床试验注册平台临床试验注册最低要求20条对各研究的注册信息完善度进行评价。结果:共纳入59项研究,最早注册时间为2016年,注册数量随时间推移总体呈上升趋势,北京、四川的在册研究相对较多,分别为10项(16.95%)和7项(11.86%)。59项安宁疗护研究中,15项研究(25.42%)为多中心研究,57项研究(96.61%)获得了伦理审批。根据注册信息的有效性统计各条目注册完善度,结果显示,59项安宁疗护研究的唯一试验注册号(ID)、试验注册日期、主要主办者、次要主办者、公众问题联系人、科学问题联系人、公众题目、正式的科学题目完善度均为100.00%;所有研究均注明了资助情况,且以省级基金居多,为15项(25.42%);干预措施项目中的干预措施说明完善度为10.17%(6项),对照措施说明完善度为6.78%(4项);59项研究均对研究类型、随机方法进行了描述,仅有29项(49.15%)研究描述了盲法实施情况;59项研究均交代了主要结局,40项(67.80%)研究交代了次要结局,对结局的量度/测量方法、主要关注的时间点完善度≤50.00%。结论:ChiCTR注册的安宁疗护研究数量总体呈增长趋势,但仍然较少,北京、四川等地注册的研究相对较多,多中心研究、伦理审查仍需进一步完善,ChiCTR注册的安宁疗护研究报告规范性不足,完整性欠佳,今后应进一步完善以提高报告质量。

Objective:To analyze the characteristics and report quality of hospice care studies registered in ChiCTR.Methods:The clinical trials related to hospice care registered in ChiCTR were searched from the establishment of the database to January 13,2024.Two researchers independently screened studies and extracted relevant information,and the completeness of each study′s registration information was evaluated using the 20 minimum requirements for clinical trial registration of the World Health Organization International Clinical Trials Registry Platform.Results:A total of 59 studies were included,the earliest registration time was 2016,and the number of registrations was generally on the rise over time.Beijing and Sichuan had relatively more registered studies,10(16.95%)and 7(11.86%),respectively.Among the 59 palliative care studies,15 studies(25.42%)were multicenter studies,and 57 studies(96.61%)obtained ethical approval.According to the validity of registration information,the registration completeness of each item was calculated.The results showed that the unique trial registration number(ID),trial registration date,main sponsor,secondary sponsor,public contact person,scientific contact person,public topic,and formal scientific topic of the 59 hospice care studies were all 100.00%.All studies indicated the funding situation,and most of them were provincial funding(15 items,25.42%).The completeness of intervention measures and control measures was 10.17%(6 items)and 6.78%(4 items),respectively.All 59 studies described the type of study and the method of randomization,but only 29(49.15%)studies described the implementation of blinding.All 59 studies reported the primary outcome,and 40 studies(67.80%)reported the secondary outcomes.The perfection of the outcome measures/measurement methods and the time point of main concern was≤50.00%.Conclusions:The number of hospice care research registered in ChiCTR is generally increasing,but the overall number is still small.There are relatively many studies registered in Beijing,Sichuan and other places,and multi-center research and ethical review still need to be further improved.Hospice research reports registered in ChiCTR are not standardized and complete,and should be further improved in the future to improve the quality of reports.