TY - JOUR
T1 - Ethical and Psychosocial Factors in the Decision-Making and Informed Consent Process for Upper Extremity Vascularized Composite Allotransplantation
T2 - A Mixed-Methods Study
AU - Gordon, Elisa J.
AU - Gacki-Smith, Jessica
AU - Kuramitsu, Brianna R.
AU - Downey, Max
AU - Vanterpool, Karen B.
AU - Nordstrom, Michelle J.
AU - Riggleman, Tiffany
AU - Cooney, Carisa M.
AU - Jensen, Sally
AU - Dumanian, Gregory
AU - Tintle, Scott
AU - Levan, MacEy
AU - Brandacher, Gerald
N1 - Funding Information:
This study was supported by the Department of Defense through the Congressionally Directed Medical Research Program (CDMRP) Reconstructive Transplant Research Program (RTRP) grant awards: Initiating Principal Investigator: E.J.G. (Grant No. W81XWH-19-2-0033); Partnering Principal Investigators: M.L. (Grant No. W81XWH-19-2-0034); G.B. (Grant No. W81XWH-19-2-0035), S.T. (Grant W81XWH1920036). The opinions and assertions expressed herein are those of the authors and do not necessarily reflect the official policy or position of the Uniformed Services University or the Department of Defense. The opinions and assertions expressed herein are those of the authors and do not necessarily reflect the official policy or position of the Henry M. Jackson Foundation for the Advancement of Military Medicine. The views expressed in this manuscript are those of the author(s) and do not necessarily reflect the official policy of the Department of Defense or the U.S. Government. The identification of specific products and scientific instrumentation does not constitute endorsement or implied endorsement on part of the authors, DOD or any component agency. The funders had no role in study design; collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication.
Funding Information:
We thank Withney Altema, Shannon Fichter, and Michelle Luken for their research assistance. We also thank our scientific advisory board members: James DuBois, Edmund Howe, Ana Iltis, and Richard Sharp. Research Electronic Data Capture, a secure online data capture application, is supported at the Feinberg School of Medicine by the NU Clinical and Translational Science Institute. Research reported in this publication was supported in part by the NIH’s National Center for Advancing Translational Sciences, grant UL1TR001422. This work was also supported in part by the Northwestern Medicine Enterprise Data Warehouse.
Publisher Copyright:
© 2023 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.
PY - 2023/7/21
Y1 - 2023/7/21
N2 - Background. Although upper extremity (UE) vascularized composite allotransplantation (VCA) aims to improve quality of life, relatively few have been performed worldwide to support evidence-based treatment and informed decision-making. Methods. We qualitatively examined factors contributing to anticipated and actual decision-making about UE VCA and perceptions of the elements of informed consent among people with UE amputations, and UE VCA candidates, participants, and recipients through in-depth interviews. Thematic analysis was used to analyze qualitative data. Results. Fifty individuals participated; most were male (78%) and had a mean age of 45 y and a unilateral amputation (84%). One-third (35%) were "a lot"or "completely"willing to pursue UE VCA. UE VCA decision-making themes included the utility of UE VCA, psychosocial impact of UE VCA and amputation on individuals' lives, altruism, and anticipated burden of UE VCA on lifestyle. Most respondents who underwent UE VCA evaluation (n = 8/10) perceived having no reasonable treatment alternatives. Generally, respondents (n = 50) recognized the potential for familial, societal, cultural, medical, and self-driven pressures to pursue UE VCA among individuals with amputations. Some (n = 9/50, 18%) reported personally feeling "a little,""somewhat,""a lot,"or "completely"pressured to pursue UE VCA. Respondents recommended that individuals be informed about the option of UE VCA near the amputation date. Conclusions. Our study identified psychosocial and other factors affecting decision-making about UE VCA, which should be addressed to enhance informed consent. Study participants' perceptions and preferences about UE VCA suggest re-examination of assumptions guiding the UE VCA clinical evaluation process.
AB - Background. Although upper extremity (UE) vascularized composite allotransplantation (VCA) aims to improve quality of life, relatively few have been performed worldwide to support evidence-based treatment and informed decision-making. Methods. We qualitatively examined factors contributing to anticipated and actual decision-making about UE VCA and perceptions of the elements of informed consent among people with UE amputations, and UE VCA candidates, participants, and recipients through in-depth interviews. Thematic analysis was used to analyze qualitative data. Results. Fifty individuals participated; most were male (78%) and had a mean age of 45 y and a unilateral amputation (84%). One-third (35%) were "a lot"or "completely"willing to pursue UE VCA. UE VCA decision-making themes included the utility of UE VCA, psychosocial impact of UE VCA and amputation on individuals' lives, altruism, and anticipated burden of UE VCA on lifestyle. Most respondents who underwent UE VCA evaluation (n = 8/10) perceived having no reasonable treatment alternatives. Generally, respondents (n = 50) recognized the potential for familial, societal, cultural, medical, and self-driven pressures to pursue UE VCA among individuals with amputations. Some (n = 9/50, 18%) reported personally feeling "a little,""somewhat,""a lot,"or "completely"pressured to pursue UE VCA. Respondents recommended that individuals be informed about the option of UE VCA near the amputation date. Conclusions. Our study identified psychosocial and other factors affecting decision-making about UE VCA, which should be addressed to enhance informed consent. Study participants' perceptions and preferences about UE VCA suggest re-examination of assumptions guiding the UE VCA clinical evaluation process.
UR - http://www.scopus.com/inward/record.url?scp=85168330872&partnerID=8YFLogxK
U2 - 10.1097/TXD.0000000000001515
DO - 10.1097/TXD.0000000000001515
M3 - Article
AN - SCOPUS:85168330872
SN - 2373-8731
VL - 9
SP - E1515
JO - Transplantation Direct
JF - Transplantation Direct
IS - 8
ER -