The Laboratory Effect in Breast Cancer Detection Studies

描述(由申请人提供)： 在过去的二十年里，在我们对观察员性能研究在评估诊断系统性能方面的使用的理解方面，无论是绝对的还是相对的，都取得了很大的进展。考虑到案例、读者和模式的可变性的分析方法正在迅速获得可信度；因此，它们的使用不仅在科学调查中变得普遍，而且在作为监管批准条件的系统效用的行业示范中也变得普遍。ROC类型的系统评估和比较方法已经成为一种非常通用的工具，可以在实验室环境中解决广泛的科学和临床问题。在所有这些研究中，更重要的问题不是能否概括出研究/I实验室条件下的病例、读者、异常和模式，而是能够有效地推断不同技术或实践对实际临床环境的潜在影响。尽管这可能是直觉上的，但到目前为止，还没有确凿的证据支持后者。在这方面，我们拥有的非常有限的实验数据表明情况恰恰相反。这个项目的主要目标是确定和比较建议召回的观察员在临床环境中检测乳腺癌的表现水平与他们在实验室建议召回和检测乳腺癌方面的表现。这将通过从质量保证和临床记录中追溯地确定和验证参与者的表现水平来完成，并通过执行两种模式的观察者表现研究来实现，一种是模拟临床环境中的评级，另一种是ROC类型的研究。在一种模式中，我们将模拟临床环境(使用BI-RADS评级)，另一种模式将包括ROC类型的研究(使用置信度评级)。读者将回顾和解释他们以前在临床上前瞻性诊断的病例，以及其他人诊断的病例。我们试图做的比较是我们能力的核心(或不是)，以有效的方式将实验室观察员的表现数据推广到一般临床环境。

DESCRIPTION (provided by applicant): Great progress has been made in the last two decades in our understanding of the use of observer performance studies in the evaluation of diagnostic systems performance, both in absolute and in relative terms. Analytical approaches that account for variability of cases, readers, and modes are rapidly gaining credibility; hence, their use is becoming common not only in scientific investigations, but also in industry demonstrations of system utility as a condition for regulatory approvals. ROC-type methodology for systems evaluations and comparisons has become an extremely versatile tool that can address a wide range of scientific and clinical questions in the laboratory environment. The more important question of interest in all of these studies is not the ability to generalize to cases, readers, abnormalities and modalities under the study/I laboratory conditions, but rather to enable valid inferences on the potential impact of different technologies orI practices on the actual clinical environment. Although intuitive perhaps, to date, there is no conclusivel evidence for the latter. The very limited experimental data we have in this regard suggests the contrary. The primary goal being pursued in this project is to determine and compare the performance levels of observers recommending recall leading to the detection of breast cancers in the clinical environment with their performance in recommending recall and detecting breast cancers in the laboratory. This will be done by ascertaining and verifying performance levels of participants retrospectively from QA and clinical records and by performing a two-mode observer performance study, one simulating the ratings in the clinical environment and the other, an ROC-type study. In one mode we will be simulating the clinical environment (using BI-RADS ratings) and the other will include an ROC-type study (using confidence ratings). Readers will review and interpret both cases that they had previously diagnosed prospectively in the clinic, as well as cases diagnosed by others. The comparison we are attempting to do is at the very core of our ability (or not) to generalize laboratory observer performance data to the general clinical environment in a valid manner.