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

Abstract

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.

Patient definitions of transplant success in upper extremity vascularized composite allotransplantation: A mixed-methods study

“…22,23 The findings reported herein were part of a larger study examining informed consent and treatment decision-making about UE VCA. 24…”

The role of the purposeful shared decision making model in vascularized composite allotransplantation

“…Earlier work from our team ( 17 , 18 , 23 ) and other literature indicate that patients’ reasons for proceeding, or not, with VCA are multifaceted and motivated by different issues ( 16 , 19 , 24 – 26 ). Some patients, for instance, seek VCA treatment driven by a strong inner will to obtain it and for whom the substantial risks of surgery, rehabilitation, and lifelong immunosuppression hold little sway in decision making.…”

“…People don’t forget you, you forget them but, oh yeah, you’re the one-armed person and you know they’ll think that in their head but won’t say it” ( 16 ) “It has always been important to me to have new real hands and not plastic or silicone hands.” UE. transplant recipient ( 53 ) “Uh, me personally, I just couldn’t get past the portion of wearing-in my head, I like look like at it as wearing somebody else’s arm, like a cadaver arm” ( 26 ) …”

“…“Uh, me personally, I just couldn’t get past the portion of wearing-in my head, I like look like at it as wearing somebody else’s arm, like a cadaver arm” ( 26 )…”