Appropriate Statistical Methods to Assess Cross-study Diagnostic 23-Gene Expression Profile Test Performance for Cutaneous Melanocytic Neoplasms.

IF 1.1 4区 医学 Q4 DERMATOLOGY
Matthew S Goldberg, Clay J Cockerell, Jason H Rogers, Jennifer J Siegel, Brooke H Russell, Gregory A Hosler, Etan Marks
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Abstract

Abstract: Comparing studies of molecular ancillary diagnostic tests for difficult-to-diagnose cutaneous melanocytic neoplasms presents a methodological challenge, given the disparate ways accuracy metrics are calculated. A recent report by Boothby-Shoemaker et al investigating the real-world accuracy of the 23-gene expression profile (23-GEP) test highlights this methodological difficulty, reporting lower accuracy than previously observed. However, their calculation method-with indeterminate test results defined as either false positive or false negative-was different than those used in previous studies. We corrected for these differences and recalculated their reported accuracy metrics in the same manner as the previous studies to enable appropriate comparison with previously published reports. This corrected analysis showed a sensitivity of 92.1% (95% confidence interval [CI], 82.1%-100%) and specificity of 94.4% (91.6%-96.9%). We then compared these results directly to previous studies with >25 benign and >25 malignant cases with outcomes and/or concordant histopathological diagnosis by ≥3 dermatopathologists. All studies assessed had enrollment imbalances of benign versus malignant patients (0.8-7.0 ratio), so balanced cohorts were resampled according to the lowest common denominator to calculate point estimates and CIs for accuracy metrics. Overall, we found no statistically significant differences in the ranges of 23-GEP sensitivity, 90.4%-96.3% (95% CI, 80.8%-100%), specificity, 87.3%-96.2% (78.2%-100%), positive predictive value, 88.5%-96.1% (81.5%-100%), or negative predictive value, 91.1%-96.3% (83.6%-100%) between previous studies and the cohort from Boothby-Shoemaker et al with this unified methodological approach. Rigorous standardization of calculation methods is necessary when the goal is direct cross-study comparability.

评估皮肤黑色素细胞肿瘤 23 基因表达谱交叉研究诊断测试性能的适当统计方法。
摘要:对难以诊断的皮肤黑色素细胞肿瘤的分子辅助诊断测试研究进行比较是一项方法学挑战,因为准确性指标的计算方法各不相同。Boothby-Shoemaker 等人最近对 23 基因表达谱(23-GEP)检验的实际准确性进行了调查,报告的准确性低于之前观察到的准确性,这凸显了方法学上的困难。然而,他们的计算方法--将不确定的检测结果定义为假阳性或假阴性--与之前研究中使用的方法不同。我们对这些差异进行了校正,并以与之前研究相同的方式重新计算了他们报告的准确度指标,以便与之前发表的报告进行适当比较。校正后的分析结果显示,灵敏度为 92.1%(95% 置信区间 [CI],82.1%-100%),特异度为 94.4%(91.6%-96.9%)。然后,我们将这些结果直接与之前由≥3 位皮肤病理学家对结果和/或组织病理诊断一致的>25 个良性病例和>25 个恶性病例进行的研究进行了比较。所有被评估的研究都存在良性与恶性患者入组不平衡的问题(0.8-7.0 的比例),因此根据最小公分母对平衡队列进行了重新取样,以计算准确性指标的点估计和 CI。总体而言,我们发现在 23-GEP 灵敏度(90.4%-96.3%,95% CI,80.8%-100%)、特异性(87.3%-96.2%,78.2%-100%)、阳性预测值(88.5%-96.1%,81.5%-100%)或阴性预测值(91.1%-96.3%,83.6%-100%)的范围内,以前的研究与 Boothby-Shoemaker 等人的队列采用这种统一的方法学方法没有明显的统计学差异。如果要实现直接的跨研究可比性,就必须对计算方法进行严格的标准化。
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来源期刊
CiteScore
1.80
自引率
9.10%
发文量
453
审稿时长
3 months
期刊介绍: The American Journal of Dermatopathology offers outstanding coverage of the latest diagnostic approaches and laboratory techniques, as well as insights into contemporary social, legal, and ethical concerns. Each issue features review articles on clinical, technical, and basic science advances and illuminating, detailed case reports. With the The American Journal of Dermatopathology you''ll be able to: -Incorporate step-by-step coverage of new or difficult-to-diagnose conditions from their earliest histopathologic signs to confirmatory immunohistochemical and molecular studies. -Apply the latest basic science findings and clinical approaches to your work right away. -Tap into the skills and expertise of your peers and colleagues the world over peer-reviewed original articles, "Extraordinary cases reports", coverage of practical guidelines, and graphic presentations. -Expand your horizons through the Journal''s idea-generating forum for debating controversial issues and learning from preeminent researchers and clinicians
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