本文已被:浏览 2318次 下载 715次 |
码上扫一扫! |
|
新型冠状病毒肺炎诊断试验设计的思考 |
吕敏之1,2, 刘天舒3,2, 朱畴文4,2
|
1.复旦大学附属中山医院生物统计室, 上海 200032;2.复旦大学循证医学中心, 上海 200032;3.复旦大学附属中山医院肿瘤内科, 上海 200032;4.复旦大学附属中山医院消化科, 上海 200032
|
|
摘要: |
新型冠状病毒肺炎(COVID-19)疫情来势汹汹,准确、快速的诊断和筛检方法显得尤为重要。国内诸多科技工作者都在积极开展相关的诊断试验。本文回顾了目前正在开展的10余项诊断试验的注册信息,针对其中存在的共性问题进行讨论,重点阐述了如何使用患者干预比较结果(PICOS)原则构造COVID-19诊断试验的研究问题,对金标准的设置、受试者的代表性、样本量计算和同步、独立、盲法的测定等诊断试验的设计要点进行了详细说明,旨在为广大研究者提供COVID-19诊断试验设计的建议,帮助研究者在顶层设计阶段减少、避免偏倚,完成高质量的临床研究,为临床诊疗提供循证医学证据。 |
关键词: 新型冠状病毒肺炎 诊断试验 研究设计 循证医学 |
DOI:10.12025/j.issn.1008-6358.2020.20200537 |
分类号:R331 |
基金项目:复旦大学附属中山医院科研基金(R-75). |
|
Thoughts on the design of COVID-19 diagnostic trials |
Lü Min-zhi1,2, LIU Tian-shu3,2, ZHU Chou-wen4,2
|
1.Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai 200032, China;2.Center of Evidence-Based Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China;3.Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai 200032, China;4.Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai 200032, China
|
Abstract: |
COVID-19 epidemic is threatening, accurate and rapid diagnosis and screening methods are particularly important. Numerous domestic scientists have been actively conducting relevant diagnostic trials and researches. This study reviewed the registration information of more than 10 diagnostic trials and discussed the common problems. This article focuses on how to use the PICOS principle to construct research questions for the COVID-19 diagnostic trial. The design points of the diagnostic test such as the setting of the gold standard, the representativeness of the subjects, the calculation of the sample size, the determination of synchronous, independent and blind method are explained in detail. The purpose of this paper is to provide suggestions for the design of COVID-19 diagnostic trials for researchers, help them to reduce and avoid bias in the top-level design stage, to complete high-quality clinical research, and provide evidence-based medicine for clinical diagnosis and treatment. |
Key words: COVID-19 diagnostic trial study design evidence-based medicine |