Clinical Epidemiology, Institute of Medical Biometry and Medical Informatics, Freiburg University Medical Center, Freiburg, Germany.
J Clin Epidemiol. 2012 Mar;65(3):293-300. doi: 10.1016/j.jclinepi.2011.07.004. Epub 2011 Oct 13.
Diagnostic studies are typically studies with two endpoints, sensitivity and specificity. To define the success of a diagnostic study, results for these two endpoints have to be combined in an appropriate manner.
Identification of criteria to define the success of a diagnostic study on a single binary test and investigation of common statistical approaches in relation to these criteria.
Three criteria for defining the overall success of a diagnostic study could be identified: a strong criterion, a liberal criterion, and a weak criterion. The strong criterion can be implemented by comparing the lower bounds of the confidence intervals for sensitivity and specificity with prespecified target values, as is typically done in many diagnostic studies. The liberal criterion allows a clinically meaningful compensation between sensitivity and specificity and can be implemented in different ways. If the liberal criterion is applied instead of the strong criterion, this can lead to a substantial reduction in the sample size required for a diagnostic study. The weak criterion is not very adequate for defining the success of a diagnostic study.
When planning and analyzing diagnostic studies, the criterion to define the success of the study should be clearly prespecified. The results of the statistical approach taken should be interpreted in accordance with this criterion. This ensures coherence of results and prevents unnecessarily large sample sizes. The liberal criterion should be paid more attention to in the future.
诊断研究通常具有两个终点，即敏感性和特异性。为了定义诊断研究的成功，必须以适当的方式组合这两个终点的结果。
确定定义单个二进制测试的诊断研究成功的标准，并研究与这些标准相关的常见统计方法。
可以确定三种定义诊断研究总体成功的标准：严格标准、宽松标准和弱标准。严格标准可以通过将敏感性和特异性的置信区间下限与预定的目标值进行比较来实现，这在许多诊断研究中通常都是这样做的。宽松标准允许在敏感性和特异性之间进行有临床意义的补偿，并且可以通过不同的方式来实现。如果应用宽松标准而不是严格标准，则可以大大减少诊断研究所需的样本量。弱标准对于定义诊断研究的成功不是很充分。
在规划和分析诊断研究时，应明确规定定义研究成功的标准。应根据该标准解释所采用的统计方法的结果。这确保了结果的一致性，并防止了不必要的大样本量。在未来应更加关注宽松标准。
