Labourier Emmanuel
BMDx, Austin, TX, USA.
Clin Endocrinol (Oxf). 2016 Oct;85(4):624-31. doi: 10.1111/cen.13096. Epub 2016 Jun 3.
Molecular testing on biopsies from thyroid nodules with indeterminate cytology can improve patient management by preventing unnecessary surgeries on benign nodules.
The aim of the study was to determine the health outcome benefits and cost-effectiveness of molecular testing in nodules with AUS/FLUS or FN/SFN cytology.
The initial diagnosis and treatment of a hypothetical cohort of adult U.S. patients with solitary thyroid nodules ≥1 cm was simulated by decision analytic modelling using Medicare cost estimates for three management strategies, standard of care without molecular testing (StC), gene expression classifier (GEC) and mutation and miRNA testing (MMT).
Gene expression classifier decreased the rate of unnecessary surgeries by 32% relative to StC, yielding incremental costs of $1008 per patient or $5070 per unnecessary surgery avoided. MMT decreased the surgery rate by 67%, yielding incremental savings of -$1384 per patient or -$3170 per unnecessary surgery avoided. Results remained robust in deterministic sensitivity analyses; MMT was dominant for every variable tested. Independent of cancer prevalence, MMT yielded 52% fewer unnecessary surgeries relative to GEC #bib70% fewer two-stage thyroidectomies and correctly identified 70% more benign nodules. Test specificity had to be >68% for molecular testing to be cost-effective and decrease by >50% the rate of unnecessary surgeries performed on benign nodules.
Molecular testing with high benign diagnostic yield can generate both positive health outcomes (less surgeries) and positive economic outputs (cost savings). These results are consistent with previously reported cost-utility data and provide valuable insights for informed decision-making by patients, physicians and payers.
对甲状腺结节细针穿刺活检结果不确定的患者进行分子检测，可避免对良性结节进行不必要的手术，从而改善患者的治疗管理。
本研究旨在确定对具有不典型鳞状细胞/意义不明确的滤泡性病变（AUS/FLUS）或滤泡性新生物/意义不明确的滤泡性病变（FN/SFN）细胞学特征的甲状腺结节进行分子检测的健康效益和成本效益。
通过决策分析模型模拟了一组假设的美国成年患者，这些患者患有单个直径≥1cm的甲状腺结节，采用三种管理策略的医疗保险成本估算进行初始诊断和治疗，这三种策略分别为不进行分子检测的标准治疗（StC）、基因表达分类器（GEC）以及突变和微小RNA检测（MMT）。
与StC相比，基因表达分类器使不必要手术率降低了32%，每位患者的增量成本为1008美元，或每避免一次不必要手术节省5070美元。MMT使手术率降低了67%，每位患者节省增量成本1384美元，或每避免一次不必要手术节省3170美元。在确定性敏感性分析中结果依然稳健；MMT在每个测试变量中均占主导地位。与癌症患病率无关，相对于GEC，MMT使不必要手术减少52%，两阶段甲状腺切除术减少70%，并正确识别出多70%的良性结节。分子检测的成本效益要求检测特异性>68%，且能使良性结节的不必要手术率降低>50%。
具有高良性诊断率的分子检测可产生积极的健康效益（减少手术）和积极的经济产出（节省成本）。这些结果与先前报告的成本效用数据一致，为患者、医生和支付方的明智决策提供了有价值的见解。
