Summers Jennifer A, Radhakrishnan Muralikrishnan, Morris Elizabeth, Chalkidou Anastasia, Rua Tiago, Patel Anita, McMillan Viktoria, Douiri Abdel, Wang Yanzhong, Ayis Salma, Higgins Joanne, Keevil Stephen, Lewis Cornelius, Peacock Janet
King's Technology Evaluation Centre, London, UK.
Division of Health and Social Care Research, King's College London, 4th Floor Addison House, Guy's Campus, London, SE1 1UL, UK.
Appl Health Econ Health Policy. 2017 Apr;15(2):139-154. doi: 10.1007/s40258-016-0277-7.
Virtual Touch™ Quantification (VTq) is a software application used with Siemens Acuson ultrasound scanners to assess the stiffness of liver tissue. The National Institute for Health and Care Excellence (NICE) Medical Technologies Advisory Committee (MTAC) selected VTq for evaluation and invited the company to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by NICE, independently assessed the evidence submitted. The EAC conducted its own systematic review, meta-analysis and economic analysis to supplement the company's submitted evidence. The meta-analyses comparing VTq and transient elastography (TE) with liver biopsy (LB) provided pooled estimates of liver stiffness and stage of fibrosis for the study populations (hepatitis B, hepatitis C or combined populations). When comparing significant fibrosis (Metavir score F ≥ 2) for both hepatitis B and C, VTq had slightly higher values for both sensitivity and specificity (77 and 81 %) than TE (76 and 71 %). The overall prevalence of cirrhosis (F4, combined populations) was similar with VTq and TE (23 vs. 23 %), and significant fibrosis (F ≥ 2) was lower for VTq than for TE (55 vs. 62 %). The EAC revised the company's de novo cost model, which resulted in a cost saving of £53 (against TE) and £434 (against LB). Following public consultation, taking into account submitted comments, NICE Medical Technology Guidance MTG27 was published in September 2015. This recommended the adoption of the VTq software to diagnose and monitor liver fibrosis in patients with hepatitis B or hepatitis C.
虚拟触诊定量分析（VTq）是一款与西门子Acuson超声扫描仪配套使用的软件应用程序，用于评估肝组织的硬度。英国国家卫生与临床优化研究所（NICE）医疗技术咨询委员会（MTAC）选择了VTq进行评估，并邀请该公司提交临床和经济证据。由NICE委托的外部评估中心（EAC）——国王技术评估中心，对提交的证据进行了独立评估。EAC进行了自己的系统评价、荟萃分析和经济分析，以补充该公司提交的证据。将VTq和瞬时弹性成像（TE）与肝活检（LB）进行比较的荟萃分析，提供了研究人群（乙型肝炎、丙型肝炎或合并人群）肝硬度和纤维化分期的汇总估计值。在比较乙型和丙型肝炎的显著纤维化（梅塔维分级F≥2）时，VTq的敏感性和特异性（分别为77%和81%）略高于TE（分别为76%和71%）。肝硬化（F4，合并人群）的总体患病率在VTq和TE中相似（分别为23%和23%），VTq的显著纤维化（F≥2）低于TE（分别为55%和62%）。EAC对该公司的全新成本模型进行了修订，结果节省了53英镑（与TE相比）和434英镑（与LB相比）。在公众咨询后，考虑到提交的意见，NICE医疗技术指南MTG27于2015年9月发布。该指南建议采用VTq软件来诊断和监测乙型或丙型肝炎患者的肝纤维化。
