用于预测疑似冠心病患者心脏风险的云端医疗设备:快速综述和概念经济模型。

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Health technology assessment Pub Date : 2024-07-01 DOI:10.3310/WYGC4096
Marie Westwood, Nigel Armstrong, Eline Krijkamp, Mark Perry, Caro Noake, Apostolos Tsiachristas, Isaac Corro-Ramos
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引用次数: 0

摘要

背景:CaRi-Heart® 设备使用预后模型估算 8 年心脏死亡风险,该模型包括血管周围脂肪衰减指数、动脉粥样硬化斑块负担和临床风险因素:对接受计算机断层扫描冠状动脉造影术的稳定型胸痛/疑似冠状动脉疾病患者进行早期价值评估,看 CaRi-Heart Risk 是否有可能成为评估心脏风险的有效、经济的辅助检查方法。该评估包括概念建模,旨在探索模型开发所需的参数结构和证据,但不包括开发完整的可执行成本效益模型:检索了从开始到 2022 年 10 月的 24 个数据库,包括 MEDLINE、MEDLINE In-Process 和 EMBASE:综述方法遵循已发布的指南。使用预测模型偏倚风险评估工具对研究质量进行评估。研究结果按研究问题进行总结:预后效果;风险类别的流行程度;临床效果;CaRi-Heart 的成本。进行了探索性检索,为概念性成本效益建模提供信息:结果:唯一一项纳入的研究表明,CaRi-Heart Risk 可预测 8 年的心源性死亡。在模型验证队列中,经吸烟、高胆固醇血症、高血压、糖尿病、杜克指数、高危斑块特征和心外膜脂肪组织体积调整后,CaRi-Heart Risk 每增加一个单位的危险比为 1.04(95% 置信区间为 1.03 至 1.06)。根据预测模型偏倚风险评估工具(Prediction model Risk Of Bias ASsessment Tool),该研究被评为偏倚风险较高,且其对本次早期价值评估所指定的决策问题的适用性存在较大问题。我们没有发现任何研究报告了使用 CaRi-Heart 评估心脏风险的临床效果或成本信息。为了给概念性成本效益建模提供信息而进行的探索性搜索表明,在根据心脏风险评估(通过任何方法)或血管炎症测量(如脂肪衰减指数)改变现有治疗方法或引入新治疗方法的效果方面,缺乏相关证据。本文介绍了一个全新的概念决策分析模型,该模型可用于对 CaRi-Heart 的成本效益进行早期评估。该模型由短期诊断模型和评估下游后果的长期模型两部分组成,可用于冠状动脉疾病的诊断和进展:本早期价值评估采用的快速审查方法和务实的额外搜索意味着,尽管描述了可能存在不确定性的领域,但我们无法明确指出哪些领域存在证据缺口:有关 CaRi-Heart Risk 临床实用性的证据尚不充分,在偏倚风险和英国临床实践的适用性方面都存在相当大的局限性。有证据表明,CaRi-Heart Risk 可预测因疑似冠状动脉疾病而接受计算机断层扫描冠状动脉造影术的患者 8 年的心脏死亡风险。然而,CaRi-Heart 是否以及在多大程度上代表了相对于现行治疗标准的改进,目前仍不确定。对 CaRi-Heart 装置的评估仍在进行中,目前可用的数据不足以为成本效益建模提供充分信息:正在进行的一项大型(n = 15,000)研究 NCT05169333(牛津风险因素和无创成像研究)预计将于 2030 年 2 月完成,该研究可能会解决本早期价值评估中发现的一些不确定因素:本研究注册为 PROSPERO CRD42022366496:该奖项由英国国家健康与护理研究所(NIHR)的证据合成计划(NIHR奖项编号:NIHR135672)资助,全文发表于《健康技术评估》(Health Technology Assessment)第28卷第31期。更多奖项信息请参阅 NIHR Funding and Awards 网站。
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A cloud-based medical device for predicting cardiac risk in suspected coronary artery disease: a rapid review and conceptual economic model.

Background: The CaRi-Heart® device estimates risk of 8-year cardiac death, using a prognostic model, which includes perivascular fat attenuation index, atherosclerotic plaque burden and clinical risk factors.

Objectives: To provide an Early Value Assessment of the potential of CaRi-Heart Risk to be an effective and cost-effective adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected coronary artery disease, undergoing computed tomography coronary angiography. This assessment includes conceptual modelling which explores the structure and evidence about parameters required for model development, but not development of a full executable cost-effectiveness model.

Data sources: Twenty-four databases, including MEDLINE, MEDLINE In-Process and EMBASE, were searched from inception to October 2022.

Methods: Review methods followed published guidelines. Study quality was assessed using Prediction model Risk Of Bias ASsessment Tool. Results were summarised by research question: prognostic performance; prevalence of risk categories; clinical effects; costs of CaRi-Heart. Exploratory searches were conducted to inform conceptual cost-effectiveness modelling.

Results: The only included study indicated that CaRi-Heart Risk may be predictive of 8 years cardiac death. The hazard ratio, per unit increase in CaRi-Heart Risk, adjusted for smoking, hypercholesterolaemia, hypertension, diabetes mellitus, Duke index, presence of high-risk plaque features and epicardial adipose tissue volume, was 1.04 (95% confidence interval 1.03 to 1.06) in the model validation cohort. Based on Prediction model Risk Of Bias ASsessment Tool, this study was rated as having high risk of bias and high concerns regarding its applicability to the decision problem specified for this Early Value Assessment. We did not identify any studies that reported information about the clinical effects or costs of using CaRi-Heart to assess cardiac risk. Exploratory searches, conducted to inform the conceptual cost-effectiveness modelling, indicated that there is a deficiency with respect to evidence about the effects of changing existing treatments or introducing new treatments, based on assessment of cardiac risk (by any method), or on measures of vascular inflammation (e.g. fat attenuation index). A de novo conceptual decision-analytic model that could be used to inform an early assessment of the cost effectiveness of CaRi-Heart is described. A combination of a short-term diagnostic model component and a long-term model component that evaluates the downstream consequences is anticipated to capture the diagnosis and the progression of coronary artery disease.

Limitations: The rapid review methods and pragmatic additional searches used to inform this Early Value Assessment mean that, although areas of potential uncertainty have been described, we cannot definitively state where there are evidence gaps.

Conclusions: The evidence about the clinical utility of CaRi-Heart Risk is underdeveloped and has considerable limitations, both in terms of risk of bias and applicability to United Kingdom clinical practice. There is some evidence that CaRi-Heart Risk may be predictive of 8-year risk of cardiac death, for patients undergoing computed tomography coronary angiography for suspected coronary artery disease. However, whether and to what extent CaRi-Heart represents an improvement relative to current standard of care remains uncertain. The evaluation of the CaRi-Heart device is ongoing and currently available data are insufficient to fully inform the cost-effectiveness modelling.

Future work: A large (n = 15,000) ongoing study, NCT05169333, the Oxford risk factors and non-invasive imaging study, with an estimated completion date of February 2030, may address some of the uncertainties identified in this Early Value Assessment.

Study registration: This study is registered as PROSPERO CRD42022366496.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135672) and is published in full in Health Technology Assessment; Vol. 28, No. 31. See the NIHR Funding and Awards website for further award information.

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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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