碳-13尿素呼气试验检测幽门螺杆菌的成本效益：一项经济学分析。
Cost-effectiveness of the carbon-13 urea breath test for the detection of Helicobacter pylori: an economic analysis.
作者信息
Masucci L, Blackhouse G, Goeree R
出版信息
Ont Health Technol Assess Ser. 2013 Oct 1;13(20):1-28. eCollection 2013.
OBJECTIVES
This analysis aimed to evaluate the cost-effectiveness of various testing strategies for Helicobacter pylori in patients with uninvestigated dyspepsia and to calculate the budgetary impact of these tests for the province of Ontario.
DATA SOURCES
Data on the sensitivity and specificity were obtained from the clinical evidence-based analysis. Resource items were obtained from expert opinion, and costs were applied on the basis of published sources as well as expert opinion.
REVIEW METHODS
A decision analytic model was constructed to compare the costs and outcomes (false-positive results, false-negative results, and misdiagnoses avoided) of the carbon-13 (¹³C) urea breath test (UBT), enzyme-linked immunosorbent assay (ELISA) serology test, and a 2-step strategy of an ELISA serology test and a confirmatory ¹³C UBT based on the sensitivity and specificity of the tests and prevalence estimates.
RESULTS
The 2-step strategy is more costly and more effective than the ELISA serology test and results in $210 per misdiagnosis case avoided. The ¹³C UBT is dominated by the 2-step strategy, i.e., it is more costly and less effective. The budget impact analysis indicates that it will cost $7.9 million more to test a volume of 129,307 patients with the ¹³C UBT than with ELISA serology, and $4.7 million more to test these patients with the 2-step strategy.
LIMITATIONS
The clinical studies that were pooled varied in the technique used to perform the breath test and in reference standards used to make comparisons with the breath test. However, these parameters were varied in a sensitivity analysis. The economic model was designed to consider intermediate outcomes only (i.e., misdiagnosed cases) and was not a complete model with final patient outcomes (e.g., quality-adjusted life years).
CONCLUSIONS
Results indicate that the 2-step strategy could be economically attractive for the testing of H. pylori. However, testing with the 2-step strategy will cost the Ministry of Health and Long-Term Care $4.7 million more than with the ELISA serology test.
目的
本分析旨在评估对未经检查的消化不良患者进行幽门螺杆菌各种检测策略的成本效益，并计算这些检测对安大略省的预算影响。
数据来源
敏感性和特异性数据来自基于临床证据的分析。资源项目来自专家意见，成本根据已发表的资料以及专家意见确定。
综述方法
构建了一个决策分析模型，以比较碳-13（¹³C）尿素呼气试验（UBT）、酶联免疫吸附测定（ELISA）血清学检测以及基于ELISA血清学检测和¹³C UBT确诊的两步策略的成本和结果（假阳性结果、假阴性结果以及避免的误诊），该模型基于检测的敏感性和特异性以及患病率估计。
结果
两步策略比ELISA血清学检测成本更高但更有效，每避免一例误诊病例花费210美元。¹³C UBT被两步策略主导，即成本更高且效果更差。预算影响分析表明，对129,307名患者进行¹³C UBT检测比ELISA血清学检测多花费790万美元，采用两步策略检测这些患者则多花费470万美元。
局限性
汇总的临床研究在进行呼气试验所使用的技术以及与呼气试验进行比较所使用的参考标准方面存在差异。然而，这些参数在敏感性分析中有所变化。经济模型仅设计用于考虑中间结果（即误诊病例），并非包含最终患者结果（如质量调整生命年）的完整模型。
结论
结果表明，两步策略在幽门螺杆菌检测方面可能具有经济吸引力。然而，与ELISA血清学检测相比，采用两步策略进行检测将使卫生和长期护理部多花费470万美元。
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