目的:梗阻性肥厚型心肌病(oHCM)患者经历了巨大的临床负担,这与高经济负担有关。峰值摄氧量(pVO2),通过心肺运动测试测量,用于量化功能能力,并在最近的临床试验中作为主要终点进行了研究。这项研究旨在收集证据以巩固pVO2在oHCM中的预后价值,并评估基于pVO2变化的经济模型预测健康结果是否可行。方法:在MEDLINE(通过PubMed)和Embase数据库中进行了针对性的文献综述,以确定pVO2作为替代健康结果的预后价值的证据,以支持未来的oHCM经济模型开发。筛选后,研究特点,提取人群特征和pVO2预后关联数据.结果:共确定了4,687项研究。3531和538项研究接受了标题/摘要和全文筛选,分别,其中151项被纳入,其中9项是肥厚型心肌病(HCM);只有3项研究关注oHCM。9项HCM研究包括1项系统性文献综述和8项主要研究,报告了基于pVO2的指标与包括全因死亡率在内的临床结局的27项潜在预测关系。心血管死亡率,心源性猝死,移植,阵发性和永久性心房颤动。pVO2被描述为单一和复合终点的预测因子,分别在3和6项研究中,有1项研究报告两者。局限性:本研究主要使用系统的文献综述方法,但由于在标题摘要和全文综述阶段不需要平行审稿人,因此不符合文献综述方法。结论:这项研究的结果表明,pVO2可预测多种健康结局,提供在经济模型开发中使用pVO2的理由。
阻塞性肥大性心肌病(oHCM)是一种心肌增厚的病症,阻碍血液流动并可能影响健康。峰值摄氧量(pVO2)测量峰值运动期间的最高耗氧量,并作为健身指标。pVO2可用于评估心脏健康,预测严重的疾病和死亡,充当代理端点。替代终点在药物研究中很有价值,因为它们允许在获得长期患者随访之前就药物批准和资金的早期决定。这项研究回顾了有关心脏病患者pVO2值与患病或死亡风险之间关系的证据。我们的目标是评估这些关系是否已经建立,以及使用它们来预测未来的治疗益处和支持新疗法的经济评估是否可行。我们的评论发现,大多数研究报道了心力衰竭患者,只有9个专注于HCM。证据表明,心脏病患者的低pVO2值与发展其他心脏病的风险增加有关,需要心脏移植,或死亡。
UNASSIGNED: Patients with obstructive hypertrophic cardiomyopathy (oHCM) experience significant clinical burden which is associated with a high economic burden. Peak oxygen uptake (pVO2), measured by cardiopulmonary exercise testing, is used to quantify functional capacity, and has been studied as a primary endpoint in recent clinical trials. This study aimed to gather evidence to consolidate the prognostic value of pVO2 in oHCM and to assess whether it is feasible to predict health outcomes in an economic model based on changes in pVO2.
UNASSIGNED: A targeted literature
review was conducted in MEDLINE (via PubMed) and Embase databases to identify evidence on the prognostic value of pVO2 as a surrogate health outcome to support future oHCM economic model development. Following screening, study characteristics, population characteristics, and pVO2 prognostic association data were extracted.
UNASSIGNED: A total of 4,687 studies were identified. In total, 3,531 and 538 studies underwent title/abstract and full-text screening, respectively, of which 151 were included and nine of these were in hypertrophic cardiomyopathy (HCM); only three studies focused on oHCM. The nine HCM studies consisted of one systematic literature
review and eight primary studies reporting on 27 potentially predictive relationships from a pVO2-based metric with clinical outcomes including all-cause mortality, cardiovascular mortality, sudden cardiac death, transplant, paroxysmal, and permanent atrial fibrillation. pVO2 was described as a predictor of single and composite endpoints, in three and six studies, respectively, with one study reporting on both.
UNASSIGNED: This study primarily uses systemic literature
review methods but does not qualify as one due to not entailing parallel reviewers during title-abstract and full-text stages of
review.
UNASSIGNED: The findings of this study suggest pVO2 is predictive of multiple health outcomes, providing a rationale to use pVO2 in the development of an economic model.
Obstructive hypertrophy cardiomyopathy (oHCM) is a condition where the heart muscle thickens, obstructing blood flow and potentially impacting health. Peak oxygen uptake (pVO2) measures the highest amount of oxygen consumption during peak exercise and serves as an indicator of fitness. pVO2 can be used to assess heart health and predict severe conditions and death, acting as a surrogate endpoint. Surrogate endpoints are valuable in drug investigations since they allow earlier decisions on drug approval and funding before longer-term patient follow-up is available.This study reviewed evidence on the relationship between pVO2 values in patients with heart disease and the risk of becoming sicker or dying. Our goal was to assess if these relationships had been established and whether it is feasible to use them to predict future treatment benefits and support economic evaluations of new treatments. Our
review found that most studies reported on patients with heart failure, with only nine focusing on HCM. Evidence indicates that low pVO2 values in patients with heart disease are linked to an increased risk of developing other heart conditions, needing a heart transplant, or dying.