Zhang Man, Hu Zhi-De
Department of Thoracic Surgery, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010050, China.
Department of Laboratory Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010050, China.
Ann Transl Med. 2019 Dec;7(23):788. doi: 10.21037/atm.2019.11.133.
The number of diagnostic test accuracy (DTA) studies concerning biomarkers have gradually increased during the past years. However, study designs remain imperfect, and the statistical methods used are not meaningful in some published studies. Here, we introduce recommendations for designing DTA studies, including consecutive enrollment of participants with uniform inclusion and exclusion criteria, blinded testing and interpretation, prespecified thresholds, and the use of one reference standard for all subjects. In addition, we also describe more relevant statistical methods in DTA studies, including decision curve analysis (DCA), nomograms, diagnostic model and scale, net reclassification index (NRI), and the integrated discriminatory index (IDI). This review may help clinicians to better design DTA studies that investigating biomarkers.
在过去几年中，关于生物标志物的诊断试验准确性（DTA）研究数量逐渐增加。然而，研究设计仍不完善，一些已发表研究中使用的统计方法并无意义。在此，我们介绍设计DTA研究的建议，包括按照统一的纳入和排除标准连续招募参与者、进行盲法检测和解读、预设阈值以及对所有受试者使用单一参考标准。此外，我们还描述了DTA研究中更相关的统计方法，包括决策曲线分析（DCA）、列线图、诊断模型和量表、净重新分类指数（NRI）以及综合鉴别指数（IDI）。本综述可能有助于临床医生更好地设计研究生物标志物的DTA研究。
