Ann Intern Med. 2013 Sep 3;159(5):325-32. doi: 10.7326/0003-4819-159-5-201309030-00006.
Clinical management of thyroid neoplasms is based on light microscopic diagnosis, but its accuracy and precision are poorly defined.
To assess inter- and intraobserver variability of preoperative cytopathologic and postoperative histopathologic thyroid diagnoses.
Samples were collected in a prospective, multicenter trial validating a gene expression classifier between June 2009 and December 2010.
14 academic and 35 community clinical sites.
653 patients with 776 surgically resected thyroid nodules of 1 cm or greater.
Intraobserver concordance among 2 or more central histopathologists who independently read histopathology slides was calculated. Interobserver concordance between the diagnoses made by the central histopathologists and those made by local pathologists were calculated. Intra- and interobserver concordance for cytopathology was similarly calculated by comparing diagnoses made by local pathologists with those made by a central panel of 3 cytopathologists.
Concordance on the histopathologic distinction between benign and malignant diagnoses was 91% comparing local with central histopathologists and 90% comparing 2 central histopathologists. Using the 6-category Bethesda System, 64.0% of diagnoses made by local and central cytopathologists and 74.7% of intraobserver diagnoses were concordant. Central cytopathologists made fewer indeterminate diagnoses than local pathologists (41.2% vs. 55.0%).
Many local pathologists did not use the Bethesda System, so their reports were translated to allow comparison. The study required histopathology, and the study population and specimens did not encompass all newly evaluated patients with a thyroid nodule.
Substantial inter- and intraobserver variability exists in the cytopathologic and histopathologic evaluation of thyroid nodules, confirming an inherent limitation of visual microscopic diagnosis.
Veracyte.
甲状腺肿瘤的临床治疗基于光镜诊断，但该方法的准确性和精确性尚未明确。
评估术前细胞病理和术后组织病理甲状腺诊断的观察者内和观察者间的变异性。
本研究为前瞻性多中心试验，于 2009 年 6 月至 2010 年 12 月期间验证基因表达分类器，采集了样本。
14 家学术机构和 35 家社区临床机构。
653 例 1 厘米或以上手术切除的甲状腺结节患者，共 776 个结节。
计算 2 位或更多独立阅读组织病理学切片的中心病理学家之间的观察者内一致性。计算中心病理学家的诊断与当地病理学家的诊断之间的观察者间一致性。通过比较当地病理学家与由 3 位细胞病理学家组成的中央小组的诊断，同样计算细胞病理学的观察者内和观察者间的一致性。
当地病理学家与中心病理学家之间在组织病理区分良性与恶性诊断的一致性为 91%，2 位中心病理学家之间的一致性为 90%。使用 6 类 Bethesda 系统，当地和中心细胞病理学家做出的 64.0%的诊断和 74.7%的观察者内诊断是一致的。中央细胞病理学家做出的不确定诊断比当地病理学家少（41.2%比 55.0%）。
许多当地病理学家未使用 Bethesda 系统，因此其报告经翻译后用于比较。该研究需要组织病理学，且研究人群和标本未包含所有新评估的甲状腺结节患者。
甲状腺结节的细胞病理和组织病理评估存在显著的观察者内和观察者间变异性，证实了肉眼显微镜诊断存在固有局限性。
Veracyte。
