■外周动脉疾病是由动脉狭窄/阻塞引起的常见病,导致血液供应减少。外周动脉疾病与血管并发症的风险增加有关,但是早期治疗降低了死亡率和发病率。腿部溃疡是持久的伤口,通常用压迫疗法治疗。压迫疗法不适合患有外周动脉疾病的人,因为它会影响动脉血供。在临床实践中,通过使用血压计和手动多普勒设备测量踝臂压指数来识别患有外周动脉疾病的人。然而,这种方法对于患有腿部溃疡的人来说可能是不舒服的,并且已经提出了自动化设备作为更可接受的替代方案。本评估的目的是总结使用自动化设备检测腿部溃疡患者外周动脉疾病的临床和成本效益证据。
■。
■为了确定相关研究的报告,我们搜索了主要的电子数据库,并仔细检查了受调查的自动化设备制造商提供的信息。由于缺乏腿部溃疡患者的证据,我们考虑了在接受踝-臂压指数评估的人群中,任何设计评估自动装置与可接受参考装置的研究的证据.我们总结了有关自动化设备的诊断准确性以及与参考设备的一致性水平的信息。对于每个设备,当数据允许时,我们通过使用分层汇总接收操作特征模型进行随机效应荟萃分析,汇集了所有研究的数据.
■一种经济模型,包括决策树(24周)和马尔可夫模型,用于捕获与静脉相关的终生成本和质量调整寿命年,腿部溃疡患者的动脉和混合病因疾病。从英国国家卫生服务和个人社会服务的角度进行了分析。成本和质量调整后的使用年限每年折现为3.5%。使用确定性和一些概率分析来捕获围绕一系列乐观和悲观假设的不确定性,这些假设涉及自动化测试对健康结果(溃疡愈合和动脉疾病的侵入性管理要求)的影响。
■。
■从电子搜索检索到的116条记录中,我们纳入了24项研究,评估了五种设备(BlueDop血管专家,BOSOABI系统100,多普勒能力,MESI踝臂压指数MD和WatchBPOfficeABI)。两项评估腿部溃疡患者的研究发现,自动化设备通常比手动多普勒(低估动脉疾病)提供更高的踝肱压指数读数。在涉及没有腿部溃疡的人的22项研究中,自动化设备通常表现出良好的特异性和中等特异性。对12项研究的荟萃分析显示,外周动脉疾病检测的合并敏感性为64%(95%置信区间为57%至71%),合并特异性为96%(95%置信区间为92%至98%)。
■自动化设备的成本低于手动多普勒。然而,由于假阴性结果导致的不适当压缩动脉/混合性溃疡的侵入性治疗要求的风险增加,并且由于假阳性测试结果的压缩延迟而导致的愈合时间增加,这意味着在大多数情况下,手动多普勒的成本更低,并且质量调整寿命年略高于自动装置.结果高度不确定,取决于许多假设,应该谨慎解释。
■为每个自动化设备确定的有限证据,尤其是腿部溃疡的人,其临床异质性排除了对这些设备在临床实践中的诊断性能和成本效益的任何坚定结论。
■本研究注册为PROSPEROCRD42022327588。
■该奖项由美国国家卫生与护理研究所(NIHR)证据综合计划(NIHR奖项参考:NIHR135478)资助,并在《卫生技术评估》中全文发表;卷。28号37.有关更多奖项信息,请参阅NIHR资助和奖励网站。
腿部溃疡是长期的伤口,主要是由静脉内的血流问题引起的,通过使用绷带或长袜来产生“压缩”效果。然而,对于患有外周动脉疾病的人,不应使用压迫。确定不应接受压迫治疗的外周动脉疾病患者,健康专业人员进行了一项名为“踝臂压力指数”的测试,其中包括使用一种称为“多普勒超声”的设备测量手臂和脚踝的血压。该过程是耗时的,患有腿部溃疡的人经常感到不舒服。已经提出自动化装置作为评估腿部溃疡的更可接受的选择。然而,我们需要知道这些设备是否能产生可靠的结果,并为国家卫生服务提供物有所值的服务。我们发现了24项临床研究,评估了5种自动设备来测量踝臂压力指数。患者类型和临床环境在研究之间有所不同。两项研究对腿部溃疡患者进行了评估,结果表明自动装置倾向于给出比标准多普勒更高的读数,因此,可能低估了外周动脉疾病的存在。评估没有腿部溃疡的人的22项研究的结果表明,自动化设备可以正确识别没有外周动脉疾病的人,但在识别患有外周动脉疾病的人方面不太精确。然而,没有足够的证据来证实这些装置是否足够可靠,可以在临床实践中使用。与手动多普勒相比,自动化设备在临床实践中的交付成本较低,但由于可能不准确的结果而增加了成本.我们的评估需要对这些设备在实践中如何使用做出许多假设,并且没有关于它们对患者预后影响的数据.结果高度不确定,应谨慎解释。鉴于目前的证据,对于国家卫生服务来说,自动化测试不太可能是一个方便的选择。
UNASSIGNED: Peripheral artery disease is a common condition caused by narrowing/blockage of the arteries, resulting in reduced blood supply. Peripheral artery disease is associated with an increased risk of vascular complications, but early treatment reduces mortality and morbidity. Leg ulcers are long-lasting wounds, usually treated by compression therapy. Compression therapy is not suitable for people with peripheral artery disease, as it can affect the arterial blood supply. In clinical practice, people with peripheral artery disease are identified by measurement of the ankle-brachial pressure index using a sphygmomanometer and manual Doppler device. However, this method can be uncomfortable for people with leg ulcers and automated devices have been proposed as a more acceptable alternative. The objective of this appraisal was to summarise the clinical and cost-effectiveness evidence on the use of automated devices to detect peripheral artery disease in people with leg ulcers.
UNASSIGNED: .
UNASSIGNED: To identify reports of relevant studies, we searched major electronic databases and scrutinised the information supplied by the manufacturers of the automated devices under investigation. Due to the lack of evidence on people with leg ulcers, we considered evidence from studies of any design assessing automated devices versus an acceptable reference device in any population receiving ankle-brachial pressure index assessment. We summarised information on diagnostic accuracy of the automated devices and level of agreement with the reference device. For each device, when data permit, we pooled data across studies by conducting random-effects meta-analyses using a Hierarchical Summary Receiving Operating Characteristics model.
UNASSIGNED: An economic model comprising a decision tree (24 weeks) and Markov models to capture lifetime costs and quality-adjusted life-years associated with venous, arterial and mixed aetiology disease in leg ulcer patients. Analyses were conducted from a United Kingdom National Health Service and Personal Social Services perspective. Costs and quality-adjusted life-years were discounted at 3.5% per year. Deterministic and several probabilistic analyses were used to capture uncertainty surrounding a range of optimistic and pessimistic assumptions about the impact of automated tests on health outcomes (ulcer healing and requirement for invasive management of arterial disease).
UNASSIGNED: .
UNASSIGNED: From the 116 records retrieved by the electronic searches, we included 24 studies evaluating five devices (BlueDop Vascular Expert, BOSO ABI-System 100, Dopplex Ability, MESI ankle-brachial pressure index MD and WatchBP Office ABI). Two studies assessing people with leg ulcers found that automated devices often gave higher ankle-brachial pressure index readings than manual Doppler (underestimation of arterial disease). In the 22 studies involving people without leg ulcers, automated devices generally demonstrated good specificity and moderate specificity. Meta-analysis of 12 studies showed a pooled sensitivity of 64% (95% confidence interval 57% to 71%) and a pooled specificity of 96% (95% confidence interval 92% to 98%) for detection of peripheral artery disease.
UNASSIGNED: Automated devices cost less than manual Doppler to deliver. However, increased risks of invasive treatment requirements for inappropriately compressed arterial/mixed ulcers due to false-negative results, and increased healing times due to delayed compression of false-positive test results mean that in most scenarios manual Doppler was less costly and had slightly higher quality-adjusted life-years than automated devices. Results are highly uncertain, dependent on many assumptions and should be interpreted cautiously.
UNASSIGNED: The limited evidence identified for each automated device, especially in people with leg ulcers, and its clinical heterogeneity precludes any firm conclusions on the diagnostic performance and cost-effectiveness of these devices in clinical practice.
UNASSIGNED: This study is registered as PROSPERO CRD42022327588.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135478) and is published in full in Health Technology Assessment; Vol. 28, No. 37. See the NIHR Funding and Awards website for further award information.
Leg ulcers are long-lasting wounds mostly caused by problems in blood flow in the veins, which are treated by applying bandages or stockings to create a ‘compression’ effect. However, compression should not be used in people with a condition called peripheral artery disease. To identify people with peripheral artery disease who should not receive compression therapy, health professionals perform a test called ‘ankle–brachial pressure index’, which involves taking blood pressure of the arms and ankles using a device called ‘Doppler ultrasound’. The procedure is time-consuming and people with leg ulcers often find it uncomfortable. Automated devices have been proposed as a more acceptable option for assessing leg ulcers. However, we need to know whether these devices produce reliable results and represent good value for money for the National Health Service. We found 24 clinical studies that assessed 5 automated devices to measure ankle–brachial pressure index. The type of patients and clinical setting varied between studies. Two studies assessed people with leg ulcers and showed that the automated devices tended to give higher readings than standard Doppler and, therefore, may underestimate the presence of peripheral artery disease. Results of the 22 studies assessing people without leg ulcers showed that the automated devices could correctly identify people who did not have peripheral artery disease but were less precise in identifying people with peripheral artery disease. However, there was not enough evidence to confirm if these devices are reliable enough to be used in clinical practice. Compared to manual Doppler, the automated devices were less costly to deliver in clinical practice but had increased costs due to potentially inaccurate results. Our evaluation required many assumptions about how the devices would be used in practice, and there were no data on their impact on patient outcomes. Results are highly uncertain and should be interpreted cautiously. Given current evidence, it is unlikely that automated tests are a convenient option for the National Health Service.