Smani Shayan, Jalfon Michael, Sundaresan Vinaik, Lokeshwar Soum D, Nguyen Justin, Halstuch Daniel, Khajir Ghazal, Cavallo Jaime A, Sprenkle Preston C, Leapman Michael S, Kim Isaac Y
Department of Urology, Yale University School of Medicine, New Haven, CT.
Department of Urology, Yale University School of Medicine, New Haven, CT.
Urol Oncol. 2025 Jun;43(6):396.e1-396.e7. doi: 10.1016/j.urolonc.2024.10.002. Epub 2024 Oct 22.
The Prostate Imaging Reporting & Data System (PI-RADS) scoring guidelines were developed to address the substantial variation in interpretation and reporting of prostate cancer (PCa) multiparametric MRI (mpMRI) results, and subsequent updates have sought to further improve inter-reader reliability. Nonetheless, the variability of PI-RADS scoring in real-world settings may represent a continuing challenge to the widespread standardization of prostate mpMRI and limit its overall clinical benefit.
To assess variability in mpMRI interpretation and reporting of PCa, we evaluated the discrepancies in PI-RADS scoring between community practices and a tertiary academic care center.
DESIGN, SETTING, AND PARTICIPANTS: We identified 262 mpMRI studies from nonacademic facilities, reinterpreted by radiologists at our institution between January 2016 and July 2022. Results of targeted MRI fusion biopsy were identified for 193 of these patients, totaling 302 lesions. PI-RADS scoring from both community and academic interpreters were recorded in addition to presence of clinically significant PCa (csPCa) on pathological analysis of targeted cores.
The primary outcome was inter-reader reliability via intraclass correlation (ICC) and the kappa statistic. We also assessed the diagnostic accuracy of PI-RADS scoring for detecting csPCa for both cohorts via receiver operator characteristics (ROC) analysis and compared these findings using paired-sample area difference under curve analysis.
Inter-reader agreement and reliability of PI-RADS scoring per lesion was generally poor (absolute agreement ICC = 0.393, 95% CI: 0.288-0.488; consistency ICC = 0.407, 95% CI: 0.308-0.497; kappa = 0.336, 95% CI: 0.267-0.406). Reliability results from studies obtained after the publication of PI-RADSv2.1 were similar to those of the overall analysis. No agreement was observed in the subgroup of lesions scored as PIRADS 3 by community interpreters. No statistically significant difference in diagnostic accuracy was observed between cohorts (ROC area under curve [AUC]: 0.759 vs. 0.785, respectively; P = 0.337). PI-RADS 3 was determined to be the optimal cutoff for detecting clinically significant disease in both cohorts.
Our results suggest that mpMRI diagnostic accuracy for detecting csPCa is not significantly different between academic and community practices. However, significantly poor reliability of mpMRI was observed between cohorts, suggesting the risk of introducing practice variation for community prostate cancer management. Variability, particularly for PI-RADS 3 lesions, can lead to inconsistent biopsy recommendations, which may result in missed csPCa or unnecessary biopsies.
前列腺影像报告和数据系统（PI-RADS）评分指南的制定是为了解决前列腺癌（PCa）多参数磁共振成像（mpMRI）结果解读和报告中存在的显著差异，随后的更新旨在进一步提高阅片者之间的可靠性。尽管如此，在实际临床环境中PI-RADS评分的变异性可能仍然是前列腺mpMRI广泛标准化的持续挑战，并限制其整体临床效益。
为评估PCa的mpMRI解读和报告的变异性，我们评估了社区医疗机构与三级学术医疗中心之间PI-RADS评分的差异。
设计、设置和参与者：我们从非学术机构中识别出262例mpMRI研究，于2016年1月至2022年7月间由我院放射科医生重新解读。其中193例患者的靶向MRI融合活检结果得以确定，共计302个病灶。除了在靶向穿刺核心的病理分析中确定是否存在临床显著性PCa（csPCa）外，还记录了社区和学术解读人员的PI-RADS评分。
主要结局是通过组内相关系数（ICC）和kappa统计量评估阅片者间的可靠性。我们还通过受试者操作特征（ROC）分析评估了两个队列中PI-RADS评分检测csPCa的诊断准确性，并使用曲线下配对样本面积差异分析比较了这些结果。
每个病灶的PI-RADS评分的阅片者间一致性和可靠性总体较差（绝对一致性ICC = 0.393，95%CI：0.288 - 0.488；一致性ICC = 0.407，95%CI：0.308 - 0.497；kappa = 0.336，95%CI：0.267 - 0.406）。PI-RADSv2.1发布后获得的研究的可靠性结果与总体分析结果相似。在社区解读人员评为PIRADS 3的病灶亚组中未观察到一致性。队列之间在诊断准确性上未观察到统计学显著差异（ROC曲线下面积[AUC]：分别为0.759和0.785；P = 0.337）。PI-RADS 3被确定为两个队列中检测临床显著性疾病的最佳临界值。
我们的结果表明，在学术机构和社区医疗机构中，mpMRI检测csPCa的诊断准确性没有显著差异。然而，队列之间观察到mpMRI的可靠性显著较差，这表明在社区前列腺癌管理中引入实践差异的风险。变异性，特别是对于PI-RADS 3级病灶，可能导致活检建议不一致，这可能导致漏诊csPCa或不必要的活检。
