Lewis Carol M, Chang Kuo-Ping, Pitman Martha, Faquin William C, Randolph Gregory W
Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, MA 02114, USA.
Thyroid. 2009 Jul;19(7):717-23. doi: 10.1089/thy.2008.0425.
The low incidence of thyroid cancer despite the high prevalence of thyroid nodules necessitates a screening tool to determine which patients require surgical management. The utility of fine-needle aspiration biopsy (FNAB) for this purpose requires a low false-negative (FN) rate and an acceptable sensitivity and specificity for the detection of malignancy. While reviewing our institution's experience with thyroid FNAB, we found significant discrepancies in how statistics of thyroid FNAB were tabulated and reported in the literature. Here we examine the sources of these discrepancies by evaluating large series of thyroid FNAB with regard to cytopathologic reporting and statistical calculation.
Published series of thyroid FNAB with >200 FNAB and available histological data with sufficient raw data to recalculate statistics were analyzed. Considering indeterminate and malignant results to be positive FNAB results, since, in a four-tier system, both lead to surgical management, specificity, sensitivity, accuracy, positive predictive value, negative predictive value, FN, and false-positive (FP) rates were recalculated. Differences between reported and recalculated statistics were then evaluated for significance.
Nineteen studies and 20 series were identified. The following are reported and recalculated means, respectively: for sensitivity, 81% and 86%; for specificity, 81% and 62%; for accuracy, 77% and 71%; for positive predictive value, 65% and 50%; for negative predictive value, 84% and 93%; for FN rates, 13% and 14%; for FP rates, 10% and 38%. FP rates had a mean of 1.4% when recalculated considering only malignant FNAB as positive tests. Specificity and FP rates had statistically significant differences between the means of reported and recalculated values.
Thyroid FNAB remains the screening tool of choice in the evaluation of thyroid nodules. However, the variability in the calculation of reported thyroid FNAB statistics highlights the need for uniformity in statistical reporting for accurate understanding of thyroid FNAB's clinical utility.
尽管甲状腺结节的患病率很高,但甲状腺癌的发病率较低,因此需要一种筛查工具来确定哪些患者需要手术治疗。细针穿刺活检(FNAB)用于此目的时,需要较低的假阴性(FN)率以及可接受的恶性肿瘤检测敏感性和特异性。在回顾我们机构甲状腺FNAB的经验时,我们发现甲状腺FNAB统计数据在文献中的制表和报告方式存在显著差异。在此,我们通过评估大量甲状腺FNAB的细胞病理学报告和统计计算来研究这些差异的来源。
分析已发表的甲状腺FNAB系列研究,这些研究的FNAB数量超过200例,且有可用的组织学数据及足够的原始数据以重新计算统计数据。由于在四级系统中,不确定和恶性结果均导致手术治疗,因此将不确定和恶性结果视为阳性FNAB结果,重新计算特异性、敏感性、准确性、阳性预测值、阴性预测值、FN率和假阳性(FP)率。然后评估报告的统计数据与重新计算的统计数据之间的差异是否具有显著性。
共识别出19项研究和20个系列。以下分别是报告的和重新计算的均值:敏感性分别为81%和86%;特异性分别为81%和62%;准确性分别为77%和71%;阳性预测值分别为65%和50%;阴性预测值分别为84%和93%;FN率分别为13%和14%;FP率分别为10%和38%。仅将恶性FNAB视为阳性检测重新计算时,FP率的均值为1.4%。报告的和重新计算的值的均值之间,特异性和FP率存在统计学显著差异。
甲状腺FNAB仍然是评估甲状腺结节的首选筛查工具。然而,报告的甲状腺FNAB统计数据计算的变异性凸显了统计报告统一的必要性,以便准确理解甲状腺FNAB的临床效用。