Division of Head and Neck Endocrine Surgery, Department of Otolaryngology-Head and Neck Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Endocrine Surgery, Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
JAMA Otolaryngol Head Neck Surg. 2016 Jul 1;142(7):676-82. doi: 10.1001/jamaoto.2016.0850.
Diagnostic molecular testing is used in the workup of thyroid nodules. While these tests appear to be promising in more definitively assigning a risk of malignancy, their effect on surgical decision making has yet to be demonstrated.
To investigate the effect of diagnostic molecular profiling of thyroid nodules on the surgical decision-making process.
DESIGN, SETTING, AND PARTICIPANTS: A surgical management algorithm was developed and published after peer review that incorporated individual Bethesda System for Reporting Thyroid Cytopathology classifications with clinical, laboratory, and radiological results. This algorithm was created to formalize the decision-making process selected herein in managing patients with thyroid nodules. Between April 1, 2014, and March 31, 2015, a prospective study of patients who had undergone diagnostic molecular testing of a thyroid nodule before being seen for surgical consultation was performed. The recommended management undertaken by the surgeon was then prospectively compared with the corresponding one in the algorithm. Patients with thyroid nodules who did not undergo molecular testing and were seen for surgical consultation during the same period served as a control group.
All pertinent treatment options were presented to each patient, and any deviation from the algorithm was recorded prospectively. To evaluate the appropriateness of any change (deviation) in management, the surgical histopathology diagnosis was correlated with the surgery performed.
The study cohort comprised 140 patients who underwent molecular testing. Their mean (SD) age was 50.3 (14.6) years, and 75.0% (105 of 140) were female. Over a 1-year period, 20.3% (140 of 688) had undergone diagnostic molecular testing before surgical consultation, and 79.7% (548 of 688) had not undergone molecular testing. The surgical management deviated from the treatment algorithm in 12.9% (18 of 140) with molecular testing and in 10.2% (56 of 548) without molecular testing (P = .37). In the group with molecular testing, the surgical management plan of only 7.9% (11 of 140) was altered as a result of the molecular test. All but 1 of those patients were found to be overtreated relative to the surgical histopathology analysis.
Molecular testing did not significantly affect the surgical decision-making process in this study. Among patients whose treatment was altered based on these markers, there was evidence of overtreatment.
诊断性分子检测用于甲状腺结节的检查。虽然这些检测似乎在更明确地确定恶性肿瘤风险方面很有前景，但它们对手术决策的影响尚未得到证实。
调查甲状腺结节的诊断性分子分析对手术决策过程的影响。
设计、地点和参与者：在同行评议后，制定并发表了一种外科管理算法，该算法将甲状腺细胞病理学报告的个别贝塞斯达系统分类与临床、实验室和影像学结果相结合。该算法的创建是为了将本文中选择的决策过程正式化，以管理甲状腺结节患者。在 2014 年 4 月 1 日至 2015 年 3 月 31 日期间，对接受甲状腺结节诊断性分子检测后接受手术咨询的患者进行了前瞻性研究。然后，前瞻性比较了推荐给外科医生的管理与算法中的相应管理。在此期间未接受分子检测并接受手术咨询的甲状腺结节患者作为对照组。
向每位患者提供了所有相关的治疗选择，并记录了任何偏离算法的情况。为了评估管理任何变化（偏差）的适当性，将手术组织病理学诊断与所进行的手术相关联。
研究队列包括 140 名接受分子检测的患者。他们的平均（SD）年龄为 50.3（14.6）岁，75.0%（105/140）为女性。在 1 年期间，20.3%（140/688）在手术咨询前接受了诊断性分子检测，79.7%（548/688）未接受分子检测。接受分子检测的患者中有 12.9%（18/140）和未接受分子检测的患者中有 10.2%（56/548）的手术管理与治疗算法不同（P=0.37）。在接受分子检测的患者中，只有 7.9%（11/140）的手术管理计划因分子检测而改变。除 1 例患者外，所有患者的治疗结果均高于手术组织病理学分析。
在这项研究中，分子检测并没有显著影响手术决策过程。在基于这些标志物改变治疗的患者中，存在过度治疗的证据。
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