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

项目摘要/摘要 抗凝可以预防血栓形成，但代价是增加出血的风险，而年龄较大的人 与血栓形成和出血的风险增加有关。老年人可能特别容易患上 多发病、残疾、认知等危险因素并存对出血的影响 损伤、跌倒和服用多药。出血结果的既定定义侧重于量化和 医疗保健利用率。他们没有捕捉到通常影响老年人的较小的出血量，也没有 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。我们缺乏对老年人抗凝剂相关出血的准确测量 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。的目标是 这项建议是为老年人的出血相关生活质量建立一种新的患者报告的结果衡量标准 服用抗凝剂。使用服用房颤或静脉血栓栓塞症的老年人队列 抗凝剂，我们将追求两个目标：1)为老年人开发一份患者报告的出血生活质量问卷 成人服用抗凝剂，以及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。这项提议将产生重大影响，通过 更好地反映患者的经历、目标和价值观的结果衡量标准，可以纳入 用于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，包括对生活质量随时间的变化及其影响的前瞻性测量 关于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 血流不止。

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.