诊断试验设计要点和规范

Diagnostic test design elements and specifications

疾病诊断是临床治疗和干预的基础和前提,因此诊断试验是临床研究的一个重要内容。正确了解诊断试验的设计要点、评价原则和注意事项不仅可以加强对诊断试验内涵的认识,同时也可以避免将其错误应用。此外,应用临床流行病学方法对诊断试验进行评价研究,有助于正确认识诊断试验的价值,科学解读诊断试验的结果,从而提高临床医师的诊断水平。本文从诊断试验的概念入手,讲解诊断试验的设计要点和规范,评价的基本原则,真实性、可靠性和临床应用价值的评价指标,提高诊断试验效果的方法等内容,以期为研究者们应用诊断试验提供参考。

Disease diagnosis is the basis and premise of clinical treatment and intervention,so diagnostic tests are an important part of clinical research.Correct understanding of the design points,evaluation principles and precautions of diagnostic tests can not only strengthen the knowledge of the connotation of diagnostic tests,but also avoid their wrong application.In addition,the application of clinical epidemiological methods to evaluate diagnostic tests helps to correctly recognize the value of diagnostic tests,scientifically interpret the results of diagnostic tests,and thus improve the diagnostic level of clinicians.This article starts with the concept of diagnostic tests,explains the design points and specifications of diagnostic tests,the basic principles of evaluation,the evaluation indexes of authenticity,reliability and clinical application value,and the methods to improve the effect of diagnostic tests,so as to provide reference for researchers to apply their diagnostic tests.