Dietlein M, Weber K, Gandjour A, Moka D, Theissen P, Lauterbach K W, Schicha H
Department of Nuclear Medicine, University of Cologne, Germany.
Eur J Nucl Med. 2000 Oct;27(10):1441-56. doi: 10.1007/s002590000324.
Management of solitary pulmonary nodules (SPNs) of up to 3 cm was modelled on decision analysis comparing "wait and watch", transthoracic needle biopsy (TNB), exploratory surgery and full-ring dedicated positron emission tomography (PET) using fluorine-18 2-fluorodeoxyglucose (FDG). The incremental cost-effectiveness ratios (ICERs) were calculated for the main risk group, a cohort of 62-year-old men, using first "wait and watch" and second exploratory surgery as the baseline strategy. Based on published data, the sensitivity and specificity of FDG-PET were estimated at 0.95 and 0.80 for detecting malignancy in SPNs and at 0.74 and 0.96 for detecting metastasis in normal-sized mediastinal lymph nodes. The costs quoted correspond to reimbursement in 1999 by the public health provider in Germany. Decision analysis modelling indicates the potential cost-effectiveness of the FDG-PET strategy for management of SPNs. Taking watchful waiting as the low-cost baseline strategy, the ICER of PET [3218 euros (EUR) per life year saved] was more favourable than that of exploratory surgery (4210 EUR/year) or that of TNB (6120 EUR/year). Changing the baseline strategy to exploratory surgery, the use of PET led to cost savings and additional life expectancy. This constellation was described by a negative ICER of -6912 EUR/year. The PET algorithm was cost-effective for risk and non-risk patients. However, the ICER of PET as the preferred strategy was sensitive to a hypothetical deterioration of any PET parameters by more than 0.07. To transfer the diagnostic efficacy from controlled studies to the routine user and to maintain the cost-effectiveness of this technology, obligatory protocols for data acquisitions would need to be defined. If the prevalence of SPNs is estimated at the USA level (52 per 100,000 individuals) and assuming that multiple strategies without PET are the norm, the overall costs of a newly implemented PET algorithm would be limited to far less than one EUR per member of the public health provider in Germany.
针对直径达3厘米的孤立性肺结节（SPN）的管理，采用决策分析进行建模，比较了“观察等待”、经胸针吸活检（TNB）、 exploratory surgery（探索性手术）以及使用氟-18 2-氟脱氧葡萄糖（FDG）的全环专用正电子发射断层扫描（PET）。以“观察等待”以及其次以探索性手术作为基线策略，为主要风险组（一组62岁男性）计算了增量成本效益比（ICER）。根据已发表的数据，FDG-PET检测SPN中恶性肿瘤的敏感性和特异性估计分别为0.95和0.80，检测正常大小纵隔淋巴结转移的敏感性和特异性分别为0.74和0.96。所引用的成本对应于1999年德国公共卫生机构的报销金额。决策分析建模表明了FDG-PET策略用于管理SPN的潜在成本效益。以密切观察等待作为低成本基线策略，PET的ICER（每挽救一年生命3218欧元（EUR））比探索性手术（4210欧元/年）或TNB（6120欧元/年）更有利。将基线策略改为探索性手术时，使用PET可节省成本并延长预期寿命。这种情况的ICER为-6912欧元/年，呈负值。PET算法对有风险和无风险患者均具有成本效益。然而，作为首选策略的PET的ICER对任何PET参数超过0.07的假设性恶化很敏感。为了将对照研究中的诊断效能转化为常规使用者的效能并维持该技术的成本效益，需要定义数据采集的强制性方案。如果SPN的患病率按照美国水平估计（每10万人中有52例），并假设没有PET的多种策略是常态，那么新实施的PET算法的总体成本将限于远低于德国公共卫生机构每位成员1欧元的水平。
