King's Technology Evaluation Centre, School of Biomedical Engineering and Imaging Sciences, King's College London, 5th Floor, Becket House, 1 Lambeth Palace Road, London, SE1 7EU, UK.
King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Appl Health Econ Health Policy. 2018 Dec;16(6):779-791. doi: 10.1007/s40258-018-0427-1.
Central venous catheters are commonly used to deliver therapies and to monitor patients, and require securing at the point of percutaneous entry to avoid dislodgement. SecurAcath is a catheter securement device designed for central venous catheters. The National Institute for Health and Care Excellence, as a part of its Medical Technologies Evaluation Programme, selected this device for evaluation and invited the manufacturer, Interrad Medical, to submit clinical and economic evidence. The King's Technology Evaluation Centre, an External Assessment Centre commissioned by the National Institute for Health and Care Excellence, independently critiqued the manufacturer's submissions. The External Assessment Centre found a lack of evidence comparing SecurAcath with alternative approaches to securement (StatLock, suturing, tape securement), with one unpublished randomised controlled trial providing the strongest evidence. The External Assessment Centre conducted a new systematic review and meta-analysis and concluded that there is some evidence indicating the non-inferiority of SecurAcath compared to StatLock. The External Assessment Centre considered the manufacturer's economic model to be appropriate but made revisions to some parameters and noted significant heterogeneity in the included studies. The revised model indicated that StatLock was more cost effective than SecurAcath for catheter indwell times of up to 5 days; however, for medium- and long-term indwell times, SecurAcath was the most cost-effective option. The National Institute for Health and Care Excellence Medical Technologies Guidance MTG 34, issued in June 2017, recommended the adoption of SecurAcath for securing peripherally inserted central catheters within the National Health Service in England.
中心静脉导管常用于治疗和监测患者，并需要在经皮穿刺部位固定，以避免移位。SecurAcath 是一种专门设计用于中心静脉导管的导管固定装置。国家卫生与保健卓越研究所（NICE）作为其医疗技术评估计划的一部分，选择了该设备进行评估，并邀请制造商 Interrad Medical 提交临床和经济证据。国王技术评估中心（由 NICE 委托的外部评估中心）独立审查了制造商的提交材料。外部评估中心发现，缺乏将 SecurAcath 与替代固定方法（StatLock、缝合、胶带固定）进行比较的证据，唯一一项未发表的随机对照试验提供了最强的证据。外部评估中心进行了一项新的系统评价和荟萃分析，得出的结论是有一些证据表明 SecurAcath 与 StatLock 相比具有非劣效性。外部评估中心认为制造商的经济模型是合适的，但对一些参数进行了修订，并注意到纳入研究中存在显著的异质性。修订后的模型表明，对于导管留置时间不超过 5 天的情况，StatLock 比 SecurAcath 更具成本效益；然而，对于中、长期留置时间，SecurAcath 是最具成本效益的选择。国家卫生与保健卓越研究所（NICE）于 2017 年 6 月发布的医疗技术指南 MTG34 建议在英格兰国民保健制度中采用 SecurAcath 来固定外周插入的中心导管。
