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

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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.