Xuan Si, Zangwill Kenneth M, Ni Weiyi, Ma Junjie, Hay Joel W
Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, CA, USA.
Department of Pharmaceutical and Health Economics, School of Pharmacy, University of Southern California, Los Angeles, CA, USA.
J Gen Intern Med. 2020 Apr;35(4):1102-1110. doi: 10.1007/s11606-019-05487-5. Epub 2020 Feb 3.
No studies have evaluated the cost-effectiveness of single and two-step different diagnostic test strategies for Clostridioides difficile infection (CDI), including direct and indirect costs.
To evaluate the cost-effectiveness of commonly available diagnostic tests for CDI including nucleic acid amplification testing (NAAT) alone, glutamate dehydrogenase followed by enzyme immunoassay for toxin (GDH/EIA), GDH then NAAT (GDH/NAAT), and NAAT then EIA (NAAT/EIA).
Decision tree model from the US societal perspective with inputs derived from the literature. Willingness-to-pay threshold was set at $150,000 per quality-adjusted life year (QALY) gained. To assess the impact of uncertainty in model inputs on the findings, we performed one-way and probabilistic sensitivity analyses.
We conducted the analysis to represent a population aged 65 years old with diarrhea who received a CDI diagnostic test.
Incremental cost-effectiveness ratios (ICER) and incremental net monetary benefits (INMB).
NAAT alone was the most cost-effective approach overall; GDH/NAAT was the most cost-effective two-step option. NAAT alone led to the highest QALYs gained, at an incremental cost of $54,547 (vs. GDH/NAAT), $55,410 (vs. GDH/EIA), and $50,231 (vs. NAAT/EIA) per QALY gained. NAAT/EIA was not cost-effective compared to any other strategy. GDH/NAAT resulted in a higher QALY compared to GDH/EIA, at an incremental cost of $96,841 per QALY gained. Variability in the likelihood of comorbidities, CDI probability, and age at disease onset did not substantially change the results. One-way sensitivity analyses showed that results were most sensitive to likelihood of recurrence, followed by CDI mortality rate and probability of severe CDI. Probabilistic sensitivity analyses explored known uncertainties in the base case and confirmed the robustness of the results.
NAAT alone and GDH/NAAT (among the two-step options) were the most cost-effective diagnostic test approaches for CDI.
尚无研究评估艰难梭菌感染（CDI）的单步和两步不同诊断测试策略的成本效益，包括直接成本和间接成本。
评估常用的CDI诊断测试的成本效益，包括单独的核酸扩增检测（NAAT）、先进行谷氨酸脱氢酶检测再进行毒素酶免疫测定（GDH/EIA）、先进行GDH检测再进行NAAT检测（GDH/NAAT）以及先进行NAAT检测再进行EIA检测（NAAT/EIA）。
从美国社会视角构建决策树模型，模型输入数据来源于文献。支付意愿阈值设定为每获得一个质量调整生命年（QALY）150,000美元。为评估模型输入的不确定性对研究结果的影响，我们进行了单因素和概率敏感性分析。
我们进行分析以代表年龄为65岁且出现腹泻并接受CDI诊断测试的人群。
增量成本效益比（ICER）和增量净货币效益（INMB）。
总体而言，单独使用NAAT是最具成本效益的方法；GDH/NAAT是最具成本效益的两步法选项。单独使用NAAT带来的QALY增益最高，每获得一个QALY的增量成本为54,547美元（与GDH/NAAT相比）、55,410美元（与GDH/EIA相比）以及50,231美元（与NAAT/EIA相比）。与任何其他策略相比，NAAT/EIA不具有成本效益。与GDH/EIA相比，GDH/NAAT带来更高的QALY，每获得一个QALY的增量成本为96,841美元。合并症可能性、CDI概率以及疾病发病年龄的变异性并未显著改变结果。单因素敏感性分析表明，结果对复发可能性最为敏感，其次是CDI死亡率和严重CDI概率。概率敏感性分析探讨了基础病例中的已知不确定性，并证实了结果的稳健性。
单独使用NAAT和GDH/NAAT（在两步法选项中）是CDI最具成本效益的诊断测试方法。
