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用于预防静脉血栓栓塞的壁虎™电刺激装置:英国国家卫生与临床优化研究所医疗技术指南

The geko™ electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance.

作者信息

Summers Jennifer A, Clinch James, Radhakrishnan Muralikrishnan, Healy Andy, McMillan Viktoria, Morris Elizabeth, Rua Tiago, Ofuya Mercy, Wang Yanzhong, Dimmock Paul W, Lewis Cornelius, Peacock Janet L, Keevil Stephen F

机构信息

King's Technology Evaluation Centre, London, UK,

出版信息

Appl Health Econ Health Policy. 2015 Apr;13(2):135-47. doi: 10.1007/s40258-014-0139-0.

Abstract

The geko™ device is a single-use, battery-powered, neuromuscular electrostimulation device that aims to reduce the risk of venous thromboembolism (VTE). The National Institute for Health and Care Excellence (NICE) selected the geko™ device for evaluation, and invited the manufacturer, Firstkind Ltd, to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by the NICE, independently assessed the evidence submitted. The sponsor submitted evidence related to the geko™ device and, in addition, included studies of other related devices as further clinical evidence to support a link between increased blood flow and VTE prophylaxis. The EAC assessed this evidence, conducted its own systematic review and concluded that there is currently limited direct evidence that geko™ prevents VTE. The sponsor's cost model is based on the assumption that patients with an underlying VTE risk and subsequently treated with geko™ will experience a reduction in their baseline risk. The EAC assessed this cost model but questioned the validity of some model assumptions. Using the EACs revised cost model, the cost savings for geko™ prophylaxis against a 'no prophylaxis' strategy were estimated as £197 per patient. Following a second public consultation, taking into account a change in the original draft recommendations, the NICE medical technologies guidance MTG19 was issued in June 2014. This recommended the adoption of the geko™ for use in people with a high risk of VTE and when other mechanical/pharmacological methods of prophylaxis are impractical or contraindicated in selected patients within the National Health Service in England.

摘要

geko™设备是一种一次性使用、电池供电的神经肌肉电刺激设备,旨在降低静脉血栓栓塞(VTE)的风险。英国国家卫生与临床优化研究所(NICE)选择了geko™设备进行评估,并邀请制造商Firstkind Ltd提交临床和经济证据。由NICE委托的外部评估中心(EAC)国王技术评估中心独立评估了所提交的证据。申办方提交了与geko™设备相关的证据,此外,还纳入了其他相关设备的研究作为进一步的临床证据,以支持增加血流与预防VTE之间的联系。EAC评估了这些证据,进行了自己的系统评价,并得出结论,目前仅有有限的直接证据表明geko™可预防VTE。申办方的成本模型基于这样一种假设,即有潜在VTE风险并随后接受geko™治疗的患者其基线风险将会降低。EAC评估了该成本模型,但对一些模型假设的有效性提出了质疑。使用EAC修订后的成本模型,估计geko™预防措施相对于“无预防措施”策略每位患者可节省成本197英镑。在进行了第二次公众咨询并考虑到原始草案建议的变化后,NICE于2014年6月发布了医疗技术指南MTG19。该指南建议在英格兰国民医疗服务体系中,对于有VTE高风险的人群以及在特定患者中其他机械/药物预防方法不实用或禁忌时,采用geko™。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/051d/4376951/2943a6624834/40258_2014_139_Fig1_HTML.jpg

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