{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T03:18:13Z","timestamp":1779247093746,"version":"3.51.4"},"reference-count":43,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T00:00:00Z","timestamp":1729036800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000038","name":"u.s. food and drug administration","doi-asserted-by":"publisher","award":["75F40120C00179"],"award-info":[{"award-number":["75F40120C00179"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Vasc Med"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>In 2019, the US Food and Drug Administration issued a warning that symptomatic relief from claudication using paclitaxel-coated devices might be associated with an increase in mortality over 5 years. We designed a discrete-choice experiment (DCE) to quantify tradeoffs that patients would accept between a decreased risk of clinically driven target-vessel revascularization (CDTVR) and increased mortality risk.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Patients with claudication symptoms were recruited from seven medical centers to complete a web-based survey including eight DCE questions that presented pairs of hypothetical device profiles defined by varying risks of CDTVR and overall mortality at 2 and 5 years. Random-parameters logit models were used to estimate relative preference weights, from which the maximum-acceptable increase in 5-year mortality risk was derived.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 272 patients completed the survey. On average, patients would accept a device offering reductions in CDTVR risks from 30% to 10% at 2 years and from 40% to 30% at 5 years if the 5-year mortality risk was less than 12.6% (95% CI: 11.8\u201313.4%), representing a cut-point of 4.6 percentage points above a baseline risk of 8%. However, approximately 40% chose the device alternative with the lower 5-year mortality risk in seven (20.6%) or eight (18.0%) of the eight DCE questions regardless of the benefit offered.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Most patients in the study would accept some incremental increase in 5-year mortality risk to reduce the 2-year and 5-year risks of CDTVR by 20 and 10 percentage points, respectively. However, significant patient-level variability in risk tolerance underscores the need for systematic approaches to support benefit-risk decision making.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1358863x241290233","type":"journal-article","created":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T14:14:10Z","timestamp":1729174450000},"page":"675-683","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Quantifying patients\u2019 preferences on tradeoffs between mortality risk and reduced need for target vessel revascularization for claudication"],"prefix":"10.1177","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7654-4464","authenticated-orcid":false,"given":"Shelby D","family":"Reed","sequence":"first","affiliation":[{"name":"Preference Evaluation Research (PrefER) Group, Duke Clinical Research Institute, Durham, NC, USA"},{"name":"Department of Population Health Sciences, Duke University, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessie","family":"Sutphin","sequence":"additional","affiliation":[{"name":"Preference Evaluation Research (PrefER) Group, Duke Clinical Research Institute, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew J","family":"Wallace","sequence":"additional","affiliation":[{"name":"Preference Evaluation Research (PrefER) Group, Duke Clinical Research Institute, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan Marcos","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"Preference Evaluation Research (PrefER) Group, Duke Clinical Research Institute, Durham, NC, USA"},{"name":"Department of Population Health Sciences, Duke University, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jui-Chen","family":"Yang","sequence":"additional","affiliation":[{"name":"Preference Evaluation Research (PrefER) Group, Duke Clinical Research Institute, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F","family":"Reed Johnson","sequence":"additional","affiliation":[{"name":"Preference Evaluation Research (PrefER) Group, Duke Clinical Research Institute, Durham, NC, USA"},{"name":"Department of Population Health Sciences, Duke University, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Tsapatsaris","sequence":"additional","affiliation":[{"name":"Preference Evaluation Research (PrefER) Group, Duke Clinical Research Institute, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle E","family":"Tarver","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anindita","family":"Saha","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allen L","family":"Chen","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA"},{"name":"Current: Global Regulatory Affairs, Johnson & Johnson MedTech, Raritan, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David J","family":"Gebben","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Misti","family":"Malone","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Farb","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olufemi","family":"Babalola","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eva M","family":"Rorer","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sahil A","family":"Parikh","sequence":"additional","affiliation":[{"name":"Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica P","family":"Simons","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Massachusetts Memorial Medical Center, Worcester, MA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W Schuyler","family":"Jones","sequence":"additional","affiliation":[{"name":"Department of Medicine, Duke University Health System, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitchell W","family":"Krucoff","sequence":"additional","affiliation":[{"name":"Department of Medicine, Duke University Health System, Durham, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3861-3163","authenticated-orcid":false,"given":"Eric A","family":"Secemsky","sequence":"additional","affiliation":[{"name":"Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, 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