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Impact of Different Study Populations on Reader Behavior and Performance Metrics: Initial Results

机译：不同研究人群对读者行为和绩效指标的影响：初步结果

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The FDA recently completed a study on design methodologies surrounding the >Validation of >Imaging >Premarket >Evaluation and >Regulation called VIPER. VIPER consisted of five large reader sub-studies to compare the impact of different study populations on reader behavior as seen by sensitivity, specificity, and AUC, the area under the ROC curve (receiver operating characteristic curve). The study investigated different prevalence levels and two kinds of sampling of non-cancer patients: a screening population and a challenge population. The VIPER study compared full-field digital mammography (FFDM) to screen-film mammography (SFM) for women with heterogeneously dense or extremely dense breasts. All cases and corresponding images were sampled from Digital Mammographic Imaging Screening Trial (DMIST) archives. There were 20 readers (American Board Certified radiologists) for each sub-study, and instead of every reader reading every case (fully-crossed study), readers and cases were split into groups to reduce reader workload and the total number of observations (split-plot study). For data collection, readers first decided whether or not they would recall a patient. Following that decision, they provided an ROC score for how close or far that patient was from the recall decision threshold. Performance results for FFDM show that as prevalence increases to 50%, there is a moderate increase in sensitivity and decrease in specificity, whereas AUC is mainly flat. Regarding precision, the statistical efficiency (ratio of variances) of sensitivity and specificity relative to AUC are 0.66 at best and decrease with prevalence. Analyses comparing modalities and the study populations (screening vs. challenge) are still ongoing.
机译：FDA最近完成了关于围绕> I Imaging > P 再营销> E 评估和< strong> R 调节器称为VIPER。 VIPER由五个大型阅读器子研究组成，用于比较不同研究人群对阅读器行为的影响，如敏感性，特异性和AUC（ROC曲线（接收器工作特性曲线）下的面积）所示。该研究调查了不同的患病率和两种非癌症患者的样本：筛查人群和挑战人群。 VIPER研究比较了乳房异质性密实或极密实女性的全视野数字化乳房X线摄影（FFDM）与银幕X线乳房摄影（SFM）。所有病例和相应图像均从数字乳腺X线摄影筛查试验（DMIST）档案中取样。每个子研究都有20位读者（美国放射学会认证放射线医师），而不是每个读者都阅读每个案例（全交叉研究），而是将读者和案例分成几组，以减少读者的工作量和观察总数（拆分） -情节研究）。为了收集数据，读者首先要决定是否召回患者。做出该决定后，他们提供了该患者距召回决定阈值有多远的ROC分数。 FFDM的性能结果表明，当患病率增加到50％时，敏感性会适度增加，而特异性会降低，而AUC主要是平坦的。关于精度，灵敏度和特异性相对于AUC的统计效率（方差之比）最好为0.66，并随患病率降低。仍在进行比较模式和研究人群（筛选与挑战）的分析。

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