Assessing the Comparative and Longitudinal Benefits of Vascularized Composite Allotransplantation of the Hand

Major limb injuries have become much more common in Service members injured in recent U.S. military conflicts; nearly 300 Service members have experienced an upper extremity amputation since combat operations began in 2001. The loss of a limb, particularly a hand or arm amputation, is devastating and disabling. In addition to loss of physical functioning and independence, these injuries can significantly affect a person's emotional well-being, social interactions, and overall quality of life.

Hand transplantation is a procedure designed to address these challenges. This surgery can restore physical functions, including sensation and physical ability to use one's hand(s) independently, and qualitative evidence from our team's current project suggests that hand transplantation can also improve well-being and quality of life. However, there are risks to receiving hand transplant surgery, including the need for lifelong immunosuppression that can lead to other health problems, such as cancer or organ damage. It is difficult, therefore, for patients and doctors to weigh the risks and benefits of undergoing hand transplantation. The proposed research project will address the FY19 Reconstructive Transplant Research Program Focus Areas (1) to define/assess the benefits or value of hand transplant, including the relative value of hand transplantation compared to other treatment options and the benefits to social participation and satisfaction, and (2) to determine how psychosocial functioning changes over time within hand transplant recipients.

To address these Focus Areas, our research team proposes a new qualitative study to compare the benefits and value over time of hand transplantation versus other treatment options. We will conduct qualitative interviews with 100 participants from four different clinical groups: (1) individuals who have undergone hand transplantation, (2) individuals with severe upper-extremity injuries who have undergone limb reconstruction surgery, (3) individuals with upper-extremity amputation who use prosthetic devices, and (4) individuals with upper-extremity amputation who use osseointegrated prosthetic devices. Participants will be interviewed using open-ended questions to understand their experiences of the benefits, value, and downsides of the treatment they have received and to understand how their social interactions with family, friends, and the community and their sense of self have been affected. Participants will be interviewed again after 1 year to evaluate any changes in QOL they may have experienced over time.

Furthermore, our research team will address a major problem currently facing the hand transplant field. Specifically, the field lacks organization around what psychological, social, or quality-of-life outcomes are important to measure. Our project team will bring unity to the field by organizing scientists and clinicians to reach consensus about what outcomes should be tracked going forward. We will recommend a standard set of measures that can be used at all clinical sites. This will reduce patient burden by streamlining the information that they need to provide for future research studies. At the same time, this will allow researchers to be able to track more patients using the same kind of data to understand population-level trends. This will lead to patient outcomes being evaluated more consistently in ways that are well-studied and appropriate for them, and thus better health care for these patients by giving better information to the treatment teams. One additional benefit of consistent outcome measurement after hand transplantation would be the ability to document the value of this procedure, which, if demonstrated, could allow hand transplantation to become accessible to a much larger number of individuals in need.

Our team includes collaborators from the largest hand transplant centers in the U.S. Our team also includes experts on quality of life in rehabilitation populations and experts on qualitative research methods. We have many years of experience conducting qualitative research with individuals who have experienced sudden, life-altering injuries, including individuals with severe hand and arm injuries.

We believe this proposed collaborative qualitative research study will significantly improve the methods used for evaluating outcomes after hand transplant surgery, leading to improved clinical decision-making and improved outcomes overall. The knowledge gained from this proposed study will benefit both military Service members and civilians with amputations who are considering hand transplantation. This work will also benefit the caregivers and families of these individuals by providing research-based knowledge on the long-term risks and benefits of hand transplantation compared to other treatment options. This information may help hand transplant become a more feasible option for those with hand or arm amputations and allow more individuals to resume productive lives as a result.