Ethical Factors Impacting Patients Decisions to Pursue VCA

Background/Research Problem: For the more than 541,000 military Service personnel, civilians, and Veterans with upper-extremity (UE) amputations, standard treatment options (e.g., prosthetics, reconstructive surgery) remain imperfect. Many experience functional, physical, and psychological consequences of UE limb loss. Vascularized composite allotransplantation (VCA) (e.g., hand and UE transplantation) entails limb reconstruction to restore function, quality of life, and social engagement, rather than promote survival.VCA raises ethical concerns because of its unique goals and the limited data of the field. Specifically, VCA challenges ethical principles including:1. Non-maleficence (do no harm) – Healthy individuals undergoing UE VCA must take serious medical and psychological health risks (e.g., lifelong immunosuppressant medicines, changes to personal identity, long-term rehabilitation), but for no survival benefit. Thus, it is unclear whether the benefits outweigh the risks to justify the treatment. 2. Respect for persons (autonomy) – UE VCA is still in its nascence, with excellent functional outcomes in the 140 recipients reported worldwide to date. Thus, the little available data on VCA recipients’ psychosocial outcomes may make it hard for UE amputees to give informed consent. 3. Voluntariness: Individuals must voluntarily agree to a treatment option as part of informed consent, but some UE amputees hold feelings of desperation about changing their situation. Because emotional states can compromise comprehension about treatment, it is critical that UE amputees’ must have clear and realistic expectations about VCA to avoid jeopardizing transplant success from non-adherence. No research has empirically assessed these ethical issues for UE VCA.Assessing UE amputees’ expectations, information needs, perceptions of voluntariness, emotions, and decision-making process about VCA is important to determine whether UE amputees are making voluntary, informed treatment decisions and to identify opportunities to improve the consent process. A qualitative approach is appropriate because little is known about these phenomena, and describing them in depth can help to understand UE amputees’ experiences and develop hypotheses. Theoretically, we will use ethnographic and grounded theory qualitative methodological approaches to understand human behaviors from the “insider’s point of view,” reveal culturally embedded norms, and view phenomena in their social and economic contexts, as well as to identify social and psychological processes within a given social scene and inductively generate theory.Objective: The objectives of the proposed study are to optimize the informed consent process for UE VCA candidates.Specific Aims/Study Design:Aim 1. Qualitatively assess the decision-making and informed consent processes for VCA.Aim 2. Develop prototype educational materials (video, website, question prompt sheet) that provide patient-centered information to enhance understanding and reduce undue influence to pursue UE VCA and are sensitive to different levels of dysfunction, residual limbs, health literacy levels, and different racial/ethnic groups.Aim 3. Formatively evaluate the educational materials through usability testing of amputees’ and candidates’ understanding, satisfaction, and usability.This study will use a cross-sectional approach for qualitative data collection involving in-depth interviews and telephone and online focus groups. Qualitative data will be iteratively and independently analyzed by multiple research staff for themes emergent from the data, using the constant comparison and inductive coding methods, to reach thematic saturation as part of a grounded theory approach to generate hypotheses and build theoretical models. Descriptive statistics will be used for demographic data and usability testing of educational materials.Impact: The proposed study will address the Reconstructive Transplant Research Program’s Fiscal Year 2018 Focus Area, “Identify near- and long-term functional, quality-of-life, and psychosocial outcomes in VCA, and their influencing factors.” By identifying military personnel and civilian information needs and expectations and developing educational materials about UE VCA, the proposed study will foster UE amputees’ greater understanding of treatment options, facilitate communication with healthcare providers, facilitate informed decision-making that accords with their values and life goals, and thereby promote patient-centered care.Military Relevance: Military personnel suffer greater psychological, social, and functional consequences of limb loss than civilians due to combat conflicts. VCA provides an established functional replacement that may address military Service members’ and Veterans’ functional and psychosocial disabilities. The proposed study may benefit them immediately and long term because the Departments of Defense and Veterans Affairs have prioritized rehabilitation care to Service personnel to restore functionality, dignity, and quality of life.