{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,21]],"date-time":"2026-06-21T07:48:46Z","timestamp":1782028126197,"version":"3.54.5"},"reference-count":24,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Heart Failure"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec>\n            <jats:title>Background:<\/jats:title>\n            <jats:p>Regulatory and clinical decisions involving health technologies require judgements about relative importance of their expected benefits and risks. We sought to quantify heart-failure patients\u2019 acceptance of therapeutic risks in exchange for improved effectiveness with implantable devices.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>Individuals with heart failure recruited from a national web panel or academic medical center completed a web-based discrete-choice experiment survey in which they were randomized to one of 40 blocks of 8 experimentally controlled choice questions comprised of 2 device scenarios and a no-device scenario. Device scenarios offered an additional year of physical functioning equivalent to New York Heart Association class III or a year with improved (ie, class II) symptoms, or both, with 30-day mortality risks ranging from 0% to 15%, in-hospital complication risks ranging from 0% to 40%, and a remote adjustment device feature. Logit-based regression models fit participants\u2019 choices as a function of health outcomes, risks and remote adjustment.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>Latent-class analysis of 613 participants (mean age, 65; 49% female) revealed that two-thirds were best represented by a pro-device, more risk-tolerant class, accepting up to 9% (95% CI, 7%\u201311%) absolute risk of device-associated mortality for a one-year gain in improved functioning (New York Heart Association class II). Approximately 20% were best represented by a less risk-tolerant class, accepting a maximum device-associated mortality risk of 3% (95% CI, 1%\u20134%) for the same benefit. The remaining class had strong antidevice preferences, thus maximum-acceptable risk was not calculated.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>Quantitative evidence on benefit-risk tradeoffs for implantable heart-failure device profiles may facilitate incorporating patients\u2019 views during product development, regulatory decision-making, and clinical practice.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circheartfailure.121.008797","type":"journal-article","created":{"date-parts":[[2021,12,23]],"date-time":"2021-12-23T10:10:49Z","timestamp":1640254249000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":17,"title":["Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study"],"prefix":"10.1161","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7654-4464","authenticated-orcid":true,"given":"Shelby D.","family":"Reed","sequence":"first","affiliation":[{"name":"Department of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC."},{"name":"Duke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8229-6578","authenticated-orcid":true,"given":"Jui-Chen","family":"Yang","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Rickert","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F. Reed","family":"Johnson","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC."},{"name":"Duke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Marcos","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC."},{"name":"Duke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3222-1719","authenticated-orcid":true,"given":"Robert J.","family":"Mentz","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."},{"name":"Department of Medicine, Division of Cardiology (R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell W.","family":"Krucoff","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."},{"name":"Department of Medicine, Division of Cardiology (R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1599-2957","authenticated-orcid":true,"given":"Sreekanth","family":"Vemulapalli","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."},{"name":"Department of Medicine, Division of Cardiology (R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8974-9004","authenticated-orcid":true,"given":"Philip B.","family":"Adamson","sequence":"additional","affiliation":[{"name":"Abbott Laboratories, Austin, TX (P.B.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J.","family":"Gebben","sequence":"additional","affiliation":[{"name":"Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD (D.J.G., A.S., M.E.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liliana","family":"Rincon-Gonzalez","sequence":"additional","affiliation":[{"name":"Medical Device Innovation Consortium, Arlington, VA (L.R.-G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0306-4264","authenticated-orcid":true,"given":"Anindita","family":"Saha","sequence":"additional","affiliation":[{"name":"Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD (D.J.G., A.S., M.E.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Schaber","sequence":"additional","affiliation":[{"name":"Medtronic plc, Minneapolis, MN (D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth M.","family":"Stein","sequence":"additional","affiliation":[{"name":"Boston Scientific Corporation, Marlborough, MA (K.M.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle E.","family":"Tarver","sequence":"additional","affiliation":[{"name":"Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD (D.J.G., A.S., M.E.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dean","family":"Bruhn-Ding","sequence":"additional","affiliation":[{"name":"CVRx Inc, Minneapolis, MN (D.B.-D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.120.016760"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCHEARTFAILURE.116.003662"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccep.2020.04.007"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.05.015"},{"key":"e_1_3_2_6_2","unstructured":"U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health and Center for Biologics Evaluation and Research. 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