Pathologists' diagnosis of invasive melanoma and melanocytic proliferations: observer accuracy and reproducibility study.
Pathologists' diagnosis of invasive melanoma and melanocytic proliferations: observer accuracy and reproducibility study.
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DOI：
10.1136/bmj.j2813
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发表时间：
2017-06-28
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通讯作者：
Piepkorn MW
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作者：
Elmore JG;Barnhill RL;Elder DE;Longton GM;Pepe MS;Reisch LM;Carney PA;Titus LJ;Nelson HD;Onega T;Tosteson ANA;Weinstock MA;Knezevich SR;Piepkorn MW
目的量化病理学家对黑素细胞性皮损诊断的准确性和重复性。设计：观察者准确度和重复性研究。设定了美国10个州。参与者皮肤活检病例(n=240)，分为36组或48组。来自美国10个州的病理学家被随机分成两个阶段(阶段1和阶段2)，分别在至少8个月的间隔下对同一组病例进行独立分析。主要观察指标将病理学家的解释归纳为五类：I级(如轻度非典型性)；II级(如中度非典型性)；III级(如重度非典型性或原位黑色素瘤)；IV级(如病理分期T1a(PT1a)早期侵袭性黑色素瘤)；V级(如≥pT1b侵袭性黑色素瘤)。通过观察者内和观察者间的符合率来评估重复性，并通过与三个参考诊断的符合性来评估准确性。结果在第一阶段，187名病理学家完成了8976个独立的病例解释，每个病例平均应用了10个(SD4)不同的诊断术语。在两个阶段解释相同病例的病理学家中，当病理学家在第一阶段诊断一个病例为I级或V级时，他们在第二阶段对大多数病例给出相同的诊断(I级76.7%；V级82.6%)。然而，在被解释为II级(35.2%)、III级(59.5%)和IV级(63.2%)的病例中，观察者内的重复性较低。观察者间的平均符合率较低，但趋势相似。以有经验的病理学家的共识诊断为参考的准确率因类别而异：I，92%(95%可信区间90%至94%)；II，25%(22%至28%)；III，40%(37%至44%)；IV，43%(39%至46%)；V，72%(69%至75%)。据估计，在总体水平上，82.8%(81.0%至84.5%)的黑色素细胞皮肤活检诊断如果由经验丰富的病理学家组成的共识参考小组进行审查，其诊断将得到证实，而8.0%(6.2%至9.9%)的病例被初始病理学家过度解读，9.2%(8.8%至9.6%)的病例被低估。结论：在美国病理学家的这项大型研究中，从中度发育不良痣到早期侵袭性黑色素瘤的诊断既不能重复性，也不准确。改善临床实践的努力应该包括使用标准化的分类系统，承认病理报告中的不确定性，并开发分子标记等工具来支持病理学家的视觉评估。
Objective To quantify the accuracy and reproducibility of pathologists’ diagnoses of melanocytic skin lesions. Design Observer accuracy and reproducibility study. Setting 10 US states. Participants Skin biopsy cases (n=240), grouped into sets of 36 or 48. Pathologists from 10 US states were randomized to independently interpret the same set on two occasions (phases 1 and 2), at least eight months apart. Main outcome measures Pathologists’ interpretations were condensed into five classes: I (eg, nevus or mild atypia); II (eg, moderate atypia); III (eg, severe atypia or melanoma in situ); IV (eg, pathologic stage T1a (pT1a) early invasive melanoma); and V (eg, ≥pT1b invasive melanoma). Reproducibility was assessed by intraobserver and interobserver concordance rates, and accuracy by concordance with three reference diagnoses. Results In phase 1, 187 pathologists completed 8976 independent case interpretations resulting in an average of 10 (SD 4) different diagnostic terms applied to each case. Among pathologists interpreting the same cases in both phases, when pathologists diagnosed a case as class I or class V during phase 1, they gave the same diagnosis in phase 2 for the majority of cases (class I 76.7%; class V 82.6%). However, the intraobserver reproducibility was lower for cases interpreted as class II (35.2%), class III (59.5%), and class IV (63.2%). Average interobserver concordance rates were lower, but with similar trends. Accuracy using a consensus diagnosis of experienced pathologists as reference varied by class: I, 92% (95% confidence interval 90% to 94%); II, 25% (22% to 28%); III, 40% (37% to 44%); IV, 43% (39% to 46%); and V, 72% (69% to 75%). It is estimated that at a population level, 82.8% (81.0% to 84.5%) of melanocytic skin biopsy diagnoses would have their diagnosis verified if reviewed by a consensus reference panel of experienced pathologists, with 8.0% (6.2% to 9.9%) of cases overinterpreted by the initial pathologist and 9.2% (8.8% to 9.6%) underinterpreted. Conclusion Diagnoses spanning moderately dysplastic nevi to early stage invasive melanoma were neither reproducible nor accurate in this large study of pathologists in the USA. Efforts to improve clinical practice should include using a standardized classification system, acknowledging uncertainty in pathology reports, and developing tools such as molecular markers to support pathologists’ visual assessments.