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. 2023 Jul 21;9(8):e1515.
doi: 10.1097/TXD.0000000000001515. eCollection 2023 Aug.

Ethical and Psychosocial Factors in the Decision-Making and Informed Consent Process for Upper Extremity Vascularized Composite Allotransplantation: A Mixed-Methods Study

Elisa J Gordon  1 , Jessica Gacki-Smith  2 , Brianna R Kuramitsu  2 , Max Downey  3 , Karen B Vanterpool  3 , Michelle J Nordstrom  4 , Tiffany Riggleman  4 , Carisa M Cooney  5 , Sally Jensen  6 , Gregory Dumanian  7 , Scott Tintle  8 , Macey Levan  3   9 , Gerald Brandacher  5
Affiliations

Ethical and Psychosocial Factors in the Decision-Making and Informed Consent Process for Upper Extremity Vascularized Composite Allotransplantation: A Mixed-Methods Study

Elisa J Gordon et al. Transplant Direct. .

Abstract

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.

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Conflict of interest statement

All 8 UE VCA participants and recipients commenting about the disclosure process valued the information the transplant team disclosed. No one perceived the information as not important. Four commented that the transplant team was “very open,” “very detailed,” and respondents felt “very informed” about UE VCA. Information was most commonly provided in pamphlets, verbally, and by email. Respondents disliked paper packets due to difficulty “turning pages,” or found information “overwhelming.” Instead, they suggested providing information in a “digital form,” such as a website, and in “little sections” to prevent overwhelming patients.The authors declare no conflicts of interest.

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