Thavorn K, Coyle D
Ont Health Technol Assess Ser. 2015 Nov 1;15(19):1-58. eCollection 2015.
Liver fibrosis is characterized by a buildup of connective tissue due to chronic liver damage. Steatosis is the collection of excessive amounts of fat inside liver cells. Liver biopsy remains the gold standard for the diagnosis of liver fibrosis and steatosis, but its use as a diagnostic tool is limited by its invasive nature and high cost.
To evaluate the cost-effectiveness and budget impact of transient elastography (TE) with and without controlled attenuation parameter (CAP) for the diagnosis of liver fibrosis or steatosis in patients with hepatitis B, hepatitis C, alcoholic liver disease, and nonalcoholic fatty liver disease.
An economic literature search was performed using computerized databases. For primary economic and budget impact analyses, we obtained data from various sources, such as the Health Quality Ontario evidence-based analysis, published literature, and the Institute for Clinical Evaluative Sciences.
A systematic review of existing TE cost-effectiveness studies was conducted, and a primary economic evaluation was undertaken from the perspective of the Ontario Ministry of Health and Long-Term Care. Decision analytic models were used to compare short-term costs and outcomes of TE compared to liver biopsy. Outcomes were expressed as incremental cost per correctly diagnosed cases gained. A budget impact analysis was also conducted.
We included 10 relevant studies that evaluated the cost-effectiveness of TE compared to other noninvasive tests and to liver biopsy; no cost-effectiveness studies of TE with CAP were identified. All studies showed that TE was less expensive but associated with a decrease in the number of correctly diagnosed cases. TE also improved quality-adjusted life-years in patients with hepatitis B and hepatitis C. Our primary economic analysis suggested that TE led to cost savings but was less effective than liver biopsy in the diagnosis of liver fibrosis. TE became more economically attractive with a higher degree of liver fibrosis. TE with CAP was also less expensive and less accurate than liver biopsy.
The model did not take into account long-term costs and consequences associated with TE and liver biopsy and did not include costs to patients and their families, or patient preferences related to diagnostic information.
TE showed potential cost savings compared to liver biopsy. Further investigation is needed to determine the long-term impacts of TE on morbidity and mortality in Canada and the optimal diagnostic modality for liver fibrosis and steatosis.
肝纤维化的特征是由于慢性肝损伤导致结缔组织堆积。脂肪变性是肝细胞内过量脂肪的积聚。肝活检仍然是诊断肝纤维化和脂肪变性的金标准，但其作为诊断工具受到其侵入性和高成本的限制。
评估有无受控衰减参数（CAP）的瞬时弹性成像（TE）对乙型肝炎、丙型肝炎、酒精性肝病和非酒精性脂肪性肝病患者肝纤维化或脂肪变性诊断的成本效益和预算影响。
使用计算机数据库进行经济文献检索。对于主要的经济和预算影响分析，我们从各种来源获取数据，如安大略省卫生质量循证分析、已发表的文献以及临床评估科学研究所。
对现有的TE成本效益研究进行系统综述，并从安大略省卫生和长期护理部的角度进行主要经济评估。使用决策分析模型比较TE与肝活检的短期成本和结果。结果以每增加一例正确诊断病例的增量成本表示。还进行了预算影响分析。
我们纳入了10项相关研究，这些研究评估了TE与其他非侵入性检查以及肝活检相比的成本效益；未发现有关带CAP的TE的成本效益研究。所有研究表明，TE成本较低，但正确诊断病例数有所减少。TE还改善了乙型和丙型肝炎患者的质量调整生命年。我们的主要经济分析表明，TE可节省成本，但在肝纤维化诊断方面不如肝活检有效。肝纤维化程度越高，TE在经济上越具吸引力。带CAP的TE也比肝活检成本更低、准确性更差。
该模型未考虑与TE和肝活检相关的长期成本和后果，未包括患者及其家庭的成本，也未包括与诊断信息相关的患者偏好。
与肝活检相比，TE显示出潜在的成本节省。需要进一步研究以确定TE对加拿大发病率和死亡率的长期影响以及肝纤维化和脂肪变性的最佳诊断方式。
