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WatchBP Home A用于在高血压诊断和监测期间机会性检测心房颤动:英国国家卫生与临床优化研究所医疗技术指南

WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension: a NICE Medical Technology Guidance.

作者信息

Willits Iain, Keltie Kim, Craig Joyce, Sims Andrew

机构信息

Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Freeman Road, Newcastle upon Tyne, NE7 7DN, UK.

出版信息

Appl Health Econ Health Policy. 2014 Jun;12(3):255-65. doi: 10.1007/s40258-014-0096-7.

Abstract

The Microlife(®) 'WatchBP Home A' oscillometric blood pressure monitor detects irregular pulse, suggestive of atrial fibrillation (AF). Early detection of AF can prevent thromboembolic stroke via anticoagulation therapy. The device was considered by the Medical Technologies Evaluation Programme of the UK National Institute for Health and Care Excellence (NICE). The sponsor (Microlife) identified 10 studies. These were reviewed by an External Assessment Centre (EAC) which considered three relevant to the decision problem, including one which found the device detected AF more accurately (sensitivity 96.8%, specificity 88.8%) than pulse palpation (87.2, 81.3%). The EAC concluded the technology had potential to improve detection of AF, but the three studies had uncertain external validity. From a cost-consequence model with a 1-year timeframe, the sponsor calculated the device would reduce electrocardiogram (ECG) referrals and prevent strokes, but incur anticoagulation therapy costs, with net NHS savings of £11.6 million and prevention of 221 strokes, annually. The EAC criticised the model for its limited time horizon, and its consideration of symptomatic AF patients who were outside the scope issued by NICE. The EAC applied a de novo Markov model, with a 10-year timeframe. The per use saving was calculated as £2.98 for asymptomatic patients aged 65-74 years and £4.26 for those aged 75-84 years, with the prevention of 53-117 nonfatal and 28-65 fatal strokes per 100,000 people screened. Following consideration by the NICE Medical Technologies Advisory Committee, NICE judged that the case for adoption was supported by the evidence (Medical Technologies Guidance 13; MTG13).

摘要

Microlife(®) “WatchBP Home A”示波法血压监测仪可检测出不规则脉搏,提示心房颤动(AF)。早期检测出AF可通过抗凝治疗预防血栓栓塞性中风。英国国家卫生与临床优化研究所(NICE)的医疗技术评估项目对该设备进行了评估。申办方(Microlife)确定了10项研究。这些研究由外部评估中心(EAC)进行审查,该中心认为其中3项与决策问题相关,包括1项研究发现该设备检测AF的准确性(敏感性96.8%,特异性88.8%)高于脉搏触诊(87.2%,81.3%)。EAC得出结论,该技术有改善AF检测的潜力,但这3项研究的外部有效性不确定。根据一个为期1年的成本后果模型,申办方计算出该设备将减少心电图(ECG)转诊并预防中风,但会产生抗凝治疗费用,英国国家医疗服务体系(NHS)每年可节省1160万英镑并预防221例中风。EAC批评该模型的时间范围有限,且考虑了NICE规定范围之外的有症状AF患者。EAC应用了一个为期10年的全新马尔可夫模型。对于65 - 74岁的无症状患者,每次使用节省的费用计算为2.98英镑,对于75 - 84岁的患者为4.26英镑,每10万人筛查可预防53 - 117例非致命性中风和28 - 65例致命性中风。经NICE医疗技术咨询委员会审议后,NICE判定有证据支持采用该设备(医疗技术指南13;MTG13)。

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