{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T14:23:37Z","timestamp":1780410217109,"version":"3.54.1"},"reference-count":33,"publisher":"Public Library of Science (PLoS)","issue":"1","license":[{"start":{"date-parts":[[2025,1,29]],"date-time":"2025-01-29T00:00:00Z","timestamp":1738108800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000049","name":"National Institute on Aging","doi-asserted-by":"publisher","award":["R03AG074074"],"award-info":[{"award-number":["R03AG074074"]}],"id":[{"id":"10.13039\/100000049","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000050","name":"National Heart, Lung, and Blood Institute","doi-asserted-by":"publisher","award":["K24HL141354"],"award-info":[{"award-number":["K24HL141354"]}],"id":[{"id":"10.13039\/100000050","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000133","name":"Agency for Healthcare Research and Quality","doi-asserted-by":"publisher","award":["R18 HS27960"],"award-info":[{"award-number":["R18 HS27960"]}],"id":[{"id":"10.13039\/100000133","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Venous thromboembolism (VTE) and atrial fibrillation (AF) disproportionately affect older adults, who are at increased risk of bleeding from treatment with anticoagulant therapy. The impact of bleeding on older adults\u2019 quality of life (QoL) is poorly understood due to the lack of a validated measure of their experience. This study\u2019s purpose is to describe the first evidence-based steps in developing a new condition-specific patient-reported outcome measure (PROM) for the effect of anticoagulant-related bleeding on older adults\u2019 QoL.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>Adults aged 65 years and older with VTE or AF at the University of Utah who were eligible for anticoagulation were recruited. We purposely sampled by age, sex, race\/ethnicity, diagnosis, bleeding history and anticoagulant. In accordance with evidence-based guidelines for PROM development, focus groups were conducted to refine a hypothesized conceptual model of bleeding-related QoL and analyzed according to hybrid inductive and deductive thematic analysis methods. Focus group results were used to write a draft PROM. Semi-structured qualitative interviews were conducted to revise items on the draft PROM and were analyzed using thematic analysis to generate a final bleeding-related QoL PROM.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Twenty individuals participated in interviews, and nine in two focus groups. Median age was 81 (range 69\u201395), 52% were women and 69% were White (10% Asian, 10% Hispanic, 7% Black, 3% Native Hawaiian\/Pacific Islander). Through inductive and deductive thematic analysis of focus groups, we identified 19 themes (e.g., specific bleeding symptoms, adaptations in relationships, fatigue) that fell into 5 domains: 1) bleeding symptoms, 2) healthcare experiences, 3) social function, 4) emotional function, 5) physical function. These 19 themes and 5 domains formed the basis of the draft PROM. We conducted semi-structured cognitive interviews, and we performed thematic analysis to revise the drafted measure for clarity and relevance. The data resulted in a new PROM for bleeding-related QoL in older adults.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Employing evidence-based methods for PROM development, we found that bleeding can have a marked impact on everyday activities, emotional wellbeing and interpersonal relations for older adults. We incorporated these distinct aspects of wellbeing and function into a novel PROM for bleeding-related QoL that can inform clinical care and research after subsequent psychometric validation.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0316796","type":"journal-article","created":{"date-parts":[[2025,1,29]],"date-time":"2025-01-29T18:23:39Z","timestamp":1738175019000},"page":"e0316796","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":4,"title":["The impact of anticoagulant-related bleeding on quality of life: Development of a novel measure based on perspectives from older adults"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1377-5406","authenticated-orcid":true,"given":"Anna L.","family":"Parks","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacey L.","family":"Slager","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy M.","family":"Cizik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret C.","family":"Fang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark A.","family":"Supiano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patti P.","family":"Katz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel M.","family":"Witt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,1,29]]},"reference":[{"issue":"13","key":"pone.0316796.ref001","doi-asserted-by":"crossref","first-page":"1299","DOI":"10.1001\/jama.2021.13844","article-title":"US Emergency Department Visits Attributed to Medication Harms, 2017\u20132019","volume":"326","author":"DS Budnitz","year":"2021","journal-title":"JAMA"},{"issue":"8","key":"pone.0316796.ref002","doi-asserted-by":"crossref","first-page":"1231","DOI":"10.1111\/j.1532-5415.2006.00828.x","article-title":"Age and the risk of warfarin-associated hemorrhage: the anticoagulation and risk factors in atrial fibrillation study","volume":"54","author":"MC Fang","year":"2006","journal-title":"J Am Geriatr Soc"},{"issue":"4","key":"pone.0316796.ref003","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1111\/j.1538-7836.2005.01204.x","article-title":"Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients","volume":"3","author":"S Schulman","year":"2005","journal-title":"Journal of Thrombosis and Haemostasis"},{"issue":"11","key":"pone.0316796.ref004","doi-asserted-by":"crossref","first-page":"2119","DOI":"10.1111\/jth.13140","article-title":"Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH","volume":"13","author":"S Kaatz","year":"2015","journal-title":"Journal of Thrombosis and Haemostasis"},{"issue":"5","key":"pone.0316796.ref005","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1111\/j.1532-5415.2007.01156.x","article-title":"Geriatric Syndromes: Clinical, Research and Policy Implications of a Core Geriatric Concept","volume":"55","author":"SK Inouye","year":"2007","journal-title":"J Am Geriatr Soc"},{"issue":"1","key":"pone.0316796.ref006","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1186\/1477-7525-10-120","article-title":"The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients","volume":"10","author":"SJ Cano","year":"2012","journal-title":"Health and Quality of Life Outcomes"},{"key":"pone.0316796.ref007","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1186\/1477-7525-2-22","article-title":"A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation","volume":"2","author":"G Samsa","year":"2004","journal-title":"Health Qual Life Outcomes"},{"key":"pone.0316796.ref008","unstructured":"COSMIN [Internet]. 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