Ethical Factors Impacting Patients Decisions to Pursue VCA

More than 541,000 U.S. military Service personnel, civilians, and Veterans have an upper-limb amputation, and the number of amputations is increasing each year. Upper-limb amputations are mostly due to traumatic injuries resulting from military combat or work accidents. Treatments for upper-limb amputation include prostheses or reconstructive surgery. These options do not work well for many people because they do not sufficiently replace hand and/or arm function and sensation or cause discomfort. Thus, alternative treatment options are needed to overcome these limitations and to more effectively restore function and quality of life.

Hand and upper-extremity transplantation is a new treatment option that aims to restore motor and mobility functions and sensation of the hand/arm. More than 140 hand/arm transplants have been performed worldwide (e.g., in the United States, Austria, France, Mexico, India, Turkey, and Australia). Hand transplant recipients have reported being able to regain hand function (e.g., play piano, swim, return to work). However, studies report inconclusive psychosocial outcomes. Most hand transplant recipients report greater quality of life—mental and emotional health—than upper-limb amputees. But many hand transplant recipients have a hard time adjusting to the new hand due to psychological changes to personal identities and relationships and the extensive rehabilitation process, which includes serious side effects from taking lifelong anti-rejection medicines.

Problems with adjustment may be due to recipients having unrealistic expectations about the hand transplant's benefits. This raises several major ethical issues. First, hand transplantation requires healthy individuals to take serious health risks to restore functioning and quality of life rather than to promote survival. Thus, there is concern about doing unnecessary harm. Second, as with any clinical procedure, it is essential that the benefits outweigh the risks to justify undergoing the treatment. However, it is unclear what factors influence amputees' decisions and whether they perceive the benefits to be worth the risks. Third, because hand transplantation is so new, little information about psychosocial outcomes is available in the public arena to learn about it. Information in the news media may be sensationalized and incomplete, which may shape upper-limb amputees' understanding of and interest in transplantation and their ability to give voluntary informed consent.

Little is known about whether upper-limb amputees fully understand what they are getting into or whether they feel under pressure to seek hand transplantation. Assessing upper-limb amputees' decision-making and informed consent processes (e.g., information needs, expectations of outcomes, emotional states, and perceptions of voluntariness about hand transplantation) is highly important to determine whether amputees' decisions coincide with their values, needs, and preferences; determine whether their emotional states shape their comprehension and decision-making; assess whether decisions are voluntary; identify opportunities to improve the consent process; and foster high-quality, patient-centered care. Further, improving amputees' expectations about hand transplantation in the informed consent process is important because expectations are related to better post-surgical health outcomes in other clinical contexts (e.g., for pain, quality of life, and satisfaction).

The overall long-term objective of the proposed study is to optimize the informed consent process for upper-limb amputees. The proposed study will use qualitative research methods to 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.'

Specific Aims:

Aim 1. Qualitatively assess the decision-making and informed consent processes for hand transplantation.

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 hand transplantation 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 on amputees' and candidates' understanding, satisfaction, and usability.

By developing educational materials (e.g., a neutral, Americans with Disabilities Act-compliant website, video testimonials, and a question prompt sheet) in the 3-year award period, the proposed study will foster amputees' greater understanding of treatment options, facilitate amputees' communication with their healthcare providers, facilitate informed decision-making that better accords with their values and life goals, and thereby promote patient-cent .......