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在缺乏分子检测的情况下,亚洲人群中不确定甲状腺结节的不必要手术高发生率以及使用分子检测的成本效益:一项决策分析。

High Rates of Unnecessary Surgery for Indeterminate Thyroid Nodules in the Absence of Molecular Test and the Cost-Effectiveness of Utilizing Molecular Test in an Asian Population: A Decision Analysis.

作者信息

Fung Man Him Matrix, Tang Ching, Kwok Gin Wai, Chan Tin Ho, Luk Yan, Lui David Tak Wai, Wong Carlos King Ho, Lang Brian Hung Hin

机构信息

Division of Endocrine Surgery, Department of Surgery, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong.

Division of Medical Oncology, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong.

出版信息

Thyroid. 2025 Feb;35(2):166-176. doi: 10.1089/thy.2024.0436. Epub 2025 Jan 21.

DOI:10.1089/thy.2024.0436
PMID:39835971
Abstract

Cytologically indeterminate thyroid nodules (Bethesda class III or IV) carry a 10-40% risk of malignancy. Diagnostic lobectomies are frequently performed but negative surgeries incur unnecessary costs on the healthcare system, potential complications, and negative impacts on quality of life. Molecular tests (MTs) have been developed to reduce unnecessary surgeries. However, well-validated, high-performance MTs are often expensive, and their cost-effectiveness has not been studied in the Asian population. This study evaluates the rate of unnecessary surgery in the setting without MT (our current practice) and the cost-effectiveness of introducing a commercially available MT for the management of cytologically indeterminate thyroid nodules in a modernized city in Asia. Management decisions and outcomes of consecutive Bethesda III or IV thyroid nodules in a tertiary endocrine surgery center in Hong Kong were evaluated. Costs of health service provided by the public health system, which covers >90% of healthcare service in the city, were retrieved. A decision tree model was developed to compare the cost-effectiveness in avoiding unnecessary surgeries of current practice versus routine MT from a public healthcare provider's perspective. In our current practice, MT was not available, and patients with indeterminate nodules received either upfront lobectomy, repeat fine needle aspiration cytology (FNAC), or active surveillance. Over a 4-year period, 2157 FNACs were performed. After exclusion, 1957 FNACs were analyzed, and 18.6% were Bethesda III or IV. Thirty-six percent of these cytologically indeterminate nodules received upfront surgery, with 28% having malignancy in final pathology, that is, 72% of surgeries were unnecessary. Routine MT could reduce 82 unnecessary surgeries/year, 26% more than current practice. Routine MT resulted in an incremental cost-effectiveness ratio of Hong Kong dollar (HKD) 49,102 (US dollar [USD] 6314) per unnecessary surgery. Sensitivity analysis showed test cost of MT contributed significantly to incremental cost-effectiveness ratio. Lowering the commercial price of MT to below HKD 8044 (USD 1031) would render routine MT cost-saving. Currently, a high rate of unnecessary surgeries is being performed for cytologically indeterminate thyroid nodules. MT was more effective in reducing unnecessary surgeries than current practice, but at a higher cost. MT will become cost-saving if the test cost could be lowered.

摘要

细胞病理学结果不确定的甲状腺结节(贝塞斯达III类或IV类)的恶性风险为10%-40%。诊断性甲状腺叶切除术经常进行,但阴性手术会给医疗系统带来不必要的成本、潜在并发症以及对生活质量产生负面影响。已开发分子检测(MTs)以减少不必要的手术。然而,经过充分验证的高性能MTs通常价格昂贵,且其成本效益尚未在亚洲人群中进行研究。本研究评估了在没有MT的情况下(我们目前的做法)不必要手术的发生率,以及在亚洲一个现代化城市引入一种市售MT用于管理细胞病理学结果不确定的甲状腺结节的成本效益。对香港一家三级内分泌外科中心连续的贝塞斯达III或IV类甲状腺结节的管理决策和结果进行了评估。检索了由公共卫生系统提供的卫生服务成本,该系统覆盖了该市90%以上的医疗服务。从公共医疗服务提供者的角度开发了一个决策树模型,以比较当前做法与常规MT在避免不必要手术方面的成本效益。在我们目前的做法中,没有MT,结果不确定的结节患者接受了直接甲状腺叶切除术、重复细针穿刺活检(FNAC)或主动监测。在4年期间,共进行了2157次FNAC。排除后,分析了1957次FNAC,其中18.6%为贝塞斯达III或IV类。这些细胞病理学结果不确定的结节中有36%接受了直接手术,最终病理学显示28%为恶性,即72%的手术是不必要的。常规MT每年可减少82例不必要手术,比当前做法多26%。常规MT导致每例不必要手术的增量成本效益比为49,102港元(6314美元)。敏感性分析表明,MT的检测成本对增量成本效益比有显著贡献。将MT的商业价格降至8044港元(1031美元)以下将使常规MT节省成本。目前,对于细胞病理学结果不确定的甲状腺结节,不必要手术的发生率很高。MT在减少不必要手术方面比当前做法更有效,但成本更高。如果检测成本能够降低,MT将节省成本。

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