Development and Preliminary Validation of a Bleeding Quality of Life PatientReported Outcome Measure for Older Adults

项目概要/摘要 抗凝可以防止血栓形成，但代价是增加出血的风险，年龄较大， 与血栓形成和出血的风险增加有关。老年人可能特别容易受到 出血的影响，由于风险因素，如多发病，残疾，认知 损伤、福尔斯和多种用药。出血结局的既定定义侧重于量化， 保健利用。它们不能捕获通常影响老年人的较小出血量， 他们评估了抗凝剂相关出血对功能、独立性和其他结果的影响 对老年人很重要。我们缺乏一种老年人抗凝剂相关出血的测量方法， 反映了他们的经验，这反过来又限制了我们改善以患者为中心的结果的能力。的目标 该建议旨在建立一种新的患者报告的老年人出血相关QoL结局指标 服用抗凝剂使用心房颤动或静脉血栓栓塞的老年人队列， 抗凝剂，我们将追求两个目标：1）制定一个患者报告的出血生活质量问卷，为老年人 服用抗凝剂的成人，2）对患者报告的出血QoL进行初步验证 老年人服用抗凝剂的问卷调查。该提案将产生重大影响， 更好地反映患者体验、目标和价值观的结局指标，可纳入 临床试验和其他研究、临床护理以及公共卫生和卫生系统干预。这 工作将导致未来的项目，包括未来的测量生活质量随着时间的推移及其影响的变化 抗凝决策，以及设计有针对性的干预措施，以改善老年人的生活质量 出血。

PROJECT SUMMARY/ABSTRACT Anticoagulation can prevent thrombosis but at the expense of increased risk of bleeding, and older age is associated with increasing risk of both thrombosis and bleeding. Older adults may be particularly vulnerable to the effects of bleeding due to the co-occurrence of risk factors like multimorbidity, disability, cognitive impairment, falls and polypharmacy. Established definitions of bleeding outcomes focus on quantification and healthcare utilization. They do not capture smaller volume bleeding that commonly affects older adults, nor do they assess the effect of anticoagulant-related bleeding on function, independence and other outcomes important to older adults. We lack a measure of anticoagulant-related bleeding in older adults that accurately reflects their experience, which in turn limits our ability to improve patient-centered outcomes. The objective of this proposal is to establish a novel patient-reported outcome measure for bleeding-related QoL for older adults taking anticoagulants. Using a cohort of older adults with atrial fibrillation or venous thromboembolism taking anticoagulants, we will pursue two aims: 1) to develop a patient-reported bleeding QoL questionnaire for older adults taking anticoagulants, and 2) to perform preliminary validation of a patient-reported bleeding QoL questionnaire for older adults taking anticoagulants. This proposal will have a significant impact by generating an outcome measure that better reflects patients’ experiences, goals and values, which can be incorporated into clinical trials and other research, clinical care, and public health and health systems interventions. This work will lead to future projects including prospective measurement of changes in QoL over time and its impact on anticoagulation decision-making, as well as design of targeted interventions to improve QoL for older adults with bleeding.