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美皮康骶尾部和足跟贴剂预防压力性溃疡:NICE 医疗技术指导。

Mepilex Border Sacrum and Heel Dressings for the Prevention of Pressure Ulcers: A NICE Medical Technology Guidance.

机构信息

York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, YO10 5NQ, UK.

National Institute for Health and Care Excellence, Level 1A, City Tower, Piccadilly Plaza, Manchester, M1 4BT, UK.

出版信息

Appl Health Econ Health Policy. 2019 Aug;17(4):453-465. doi: 10.1007/s40258-019-00465-8.

Abstract

Mepilex Border Sacrum and Heel dressings are self-adherent, multilayer foam dressings designed for use on the heel and sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention. The National Institute for Health and Care Excellence (NICE) selected Mepilex Border Sacrum and Heel dressings for evaluation. The External Assessment Centre (EAC) critiqued the company's submission. Thirteen studies (four randomised controlled trials and nine nonrandomised comparative studies) were included. The majority of studies compared Mepilex Border Sacrum dressings (plus standard care) with standard care alone. Comparative evidence for Mepilex Border Heel dressings was limited. A meta-analysis indicated a non-statistically significant difference in favour of Mepilex Border Sacrum dressings for pressure ulcer incidence [RR 0.51 (95% CI 0.22-1.18)]. The company produced a de novo cost model, which was critiqued by the EAC. After the EAC updated input parameters, cost savings of £19 per patient compared with standard care alone for pressure ulcer prevention were estimated with Mepilex Border dressings predicted to be cost saving in 57% of iterations. The Medical Technologies Advisory Committee reviewed the evidence and judged that, although Mepilex Border Heel and Sacrum dressings have potential to prevent pressure ulcers in people who are considered to be at risk in acute care settings, further evidence is required to address uncertainties around the claimed benefits of the dressings and the incidence of pressure ulcers in an NHS acute-care setting. After a public consultation, NICE published this as Medical Technology Guidance 40.

摘要

美皮康骶尾部和足跟敷贴是自粘型多层泡沫敷贴,设计用于足跟和骶尾部,旨在预防压疮。这些敷贴用于预防压疮的标准护理方案之外。国家卫生与保健卓越研究所(NICE)选择美皮康骶尾部和足跟敷贴进行评估。外部评估中心(EAC)对公司的提交材料进行了评论。纳入了 13 项研究(4 项随机对照试验和 9 项非随机对照研究)。大多数研究比较了美皮康骶尾部敷贴(加标准护理)与单独标准护理。比较美皮康足跟敷贴的证据有限。荟萃分析表明,美皮康骶尾部敷贴在预防压疮方面的发生率有非统计学意义的优势[RR 0.51(95% CI 0.22-1.18)]。公司制作了一个新的成本模型,EAC 对其进行了评论。在 EAC 更新输入参数后,与单独使用标准护理相比,使用美皮康骶尾部敷贴预防压疮的预计每位患者可节省 19 英镑,预计在 57%的迭代中,美皮康骶尾部敷贴具有成本效益。医疗技术咨询委员会审查了证据,并认为,尽管美皮康足跟和骶尾部敷贴有可能预防急性护理环境中被认为存在风险的人群的压疮,但需要进一步的证据来解决有关该敷贴的声称益处和 NHS 急性护理环境中压疮发生率的不确定性。在公众咨询后,NICE 将其发布为医疗技术指南 40。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9fb1/6647510/8736ba93d726/40258_2019_465_Fig1_HTML.jpg

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