{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,20]],"date-time":"2025-11-20T18:39:18Z","timestamp":1763663958715,"version":"3.40.5"},"reference-count":15,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2019,5,29]],"date-time":"2019-05-29T00:00:00Z","timestamp":1559088000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"US Army Medical Research Acquisition Activity","award":["W81XWH-16-2-0065"],"award-info":[{"award-number":["W81XWH-16-2-0065"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["PM&amp;R"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Osseointegrated (OI) prostheses have a unique benefit\u2010risk profile among prosthetic alternatives and have been marketed in the United States under a Humanitarian Device Exemption since 2015. Information about upper limb prosthesis user perspectives on benefits and risks, prosthesis\u2010user subpopulations for whom OI is most acceptable, and outcomes that matter most to patients could help inform clinical and regulatory decision\u2010making. Recent 21st Century Cures legislation expanded the role of patient experience data in the decision\u2010making process of the U.S. Food and Drug Administration, recognizing that patient perspectives may be informative to regulators.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To better understand prosthesis user perspectives about the benefits and risks associated with upper limb OI prostheses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Patient perspective survey.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Telephone administration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>National sample of veterans with upper limb loss.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>NA<\/jats:p><\/jats:sec><jats:sec><jats:title>Main Outcome Measures<\/jats:title><jats:p>Benefit\u2010risk survey developed for this study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty\u2010eight percent of unilateral and 13% of bilateral amputees were willing to consider osseointegration surgery. Multivariate logistic regression models [OR; 95% CI] showed that transhumeral amputation level [OR 1.40; 1.01\u20101.98] was associated with greater willingness to consider surgery, whereas older age [OR 0.17; 0.09\u20100.32] and higher VR\u201012 Mental Component Summary [OR 0.53; 0.35\u20100.81] were associated with less willingness. Having a durable\/reliable device, the ability to do more activities, and having a comfortable device were rated as very important or somewhat important by 98% or more for every risk condition.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Persons who were older, had transradial amputation (compared to transhumeral), and those who had better mental functioning were less willing to consider this surgery. Respondents who were willing to consider surgery indicated that the most important potential benefits were obtaining a durable\/reliable device, the ability to do more activities, and having a comfortable device. Most were willing to accept one or more risks of surgery, with long\u2010term risks including chronic pain, loss of nerve function, or device failure considered the most unacceptable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of Evidence<\/jats:title><jats:p>III<\/jats:p><\/jats:sec>","DOI":"10.1002\/pmrj.12147","type":"journal-article","created":{"date-parts":[[2019,2,20]],"date-time":"2019-02-20T06:41:19Z","timestamp":1550644879000},"page":"1261-1271","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Patient Perspectives on Osseointegration: A National Survey of Veterans with Upper Limb Amputation"],"prefix":"10.1002","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0168-6759","authenticated-orcid":false,"given":"Linda","family":"Resnik","sequence":"first","affiliation":[{"name":"Research Department Providence VA Medical Center  Providence RI"},{"name":"Health Services, Policy and Practice Brown University, Health Services, Policy and Practice Brown University  Providence RI"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heather","family":"Benz","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, US Food &amp; Drug Administration  Silver Spring MD"},{"name":"Department of Quantitative Health Sciences University of Massachusetts Medical School  Worcester MA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Borgia","sequence":"additional","affiliation":[{"name":"Research Department Providence VA Medical Center  Providence RI"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melissa A.","family":"Clark","sequence":"additional","affiliation":[{"name":"Department of Quantitative Health Sciences University of Massachusetts Medical School  Worcester MA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,5,29]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11999-015-4604-3"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0201821"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11999-010-1370-0"},{"key":"e_1_2_6_5_1","unstructured":"WilsonH AnatchkovaM GelhornH. A perspective on the 21st Century Cures Act: patient\u2010focused drug development 2017.https:\/\/www.evidera.com\/wp-content\/uploads\/2017\/11\/04-A-Perspective-on-The-21st-Century-Cures-Act-Patient-Focused-Drug-Development_2017Nov-1.pdf. Accessed November 1\u20104 2018."},{"key":"e_1_2_6_6_1","unstructured":"KhemkaA FrossardL LordS BosleyB MuderisA eds. Health\u2010related quality of life of individuals with transfemoral amputation fitted with the Transcutaneous Bone Anchoring Prosthesis following the OGAAP. 6th International Conference Advances in Orthopaedic Osseointegration; March 26\u201027 2015; Las Vegas NV."},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.apmr.2014.07.009"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1302\/0301-620X.100B4.BJJ-2017-0968.R1"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/17434440.2018.1470505"},{"key":"e_1_2_6_10_1","doi-asserted-by":"crossref","unstructured":"ResnikL Ekerholm S Borgia M Clark M. A national study of veterans with major upper limb amputation: Survey methods participants and summary findings.PLoS One.2019;14(3):e0213578.","DOI":"10.1371\/journal.pone.0213578"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199603000-00003"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/00007632-200012150-00008"},{"key":"e_1_2_6_13_1","unstructured":"ElliotAC ReischJS. Implementing a multiple comparison test for proportions in a 2xc Crosstabulation in SAS\u00ae. Center for Biostatistics and Clinical Science: UT Southwestern Medical Center Dallas.http:\/\/www2.sas.com\/proceedings\/sugi31\/204-31.pdf. Accessed November 5 2018."},{"key":"e_1_2_6_14_1","unstructured":"American Association for Public Opinion Research.Response rates \u2010 an overview.2018;https:\/\/www.aapor.org\/Education\u2010Resources\/For\u2010Researchers\/Poll\u2010Survey\u2010FAQ\/Response\u2010Rates\u2010An\u2010Overview.aspx. 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