Posted August 15, 2023

Dr. Elisa Gordon, Vanderbilt University Medical Center
U.S. Navy Capt. (sel) Scott Tintle, Walter Reed National Military Medical Center
Dr. Macey Levan, New York University
Gerald Brandacher, Johns Hopkins University

The informed consent process for upper extremity (UE) vascularized composite allotransplantation (VCA) is not standardized across different VCA centers performing these transplants. Consequently, the amount and type of information provided to patients about UE VCA varies. Such variation may contribute to people with UE amputations being inadequately informed and under-prepared, as well as feeling unduly pressured when considering this option.

Dr. Elisa Gordon at Vanderbilt University Medical Center (formerly at Northwestern University), together with U.S. Navy Capt. (sel) Scott Tintle at Walter Reed National Military Medical Center, Dr. Macey Levan at New York University (formerly at Johns Hopkins University), and Gerald Brandacher at Johns Hopkins University, received a fiscal year 2018 Reconstructive Transplant Research Program Qualitative Research Award to examine the decision-making process, psychosocial concerns, and information needs about UE VCA among people with UE amputations. They also sought to develop educational materials (i.e., website, videos, question prompt sheet) to help people with UE amputations and their families make informed treatment decisions.

The broader multidisciplinary research team included VCA transplant surgeons, hand surgeons, occupational therapists, social scientists, and ethicists, and the project took place across three clinical sites: Northwestern University, Johns Hopkins University, and Walter Reed National Military Medical Center. The team enrolled a total of 169 participants, comprised of individuals with UE amputations, UE VCA candidates/participants, and UE VCA recipients. Data collection involved cognitive interviews, in-depth interviews, online and telephone focus groups, semi-structured interviews, and usability testing interviews.¹

Findings indicated that psychosocial factors heavily influenced decisions to pursue UE VCA, including dissatisfaction with current treatment options, desire to regain hand function, wanting to improve appearance, and seeking to regain independence. Factors and concerns influencing decisions not to pursue UE VCA included concerns about jeopardizing current health, commitment to rehabilitation, logistical burdens, and interrupting family and work life. Some participants reported that they felt there were no acceptable treatment options for UE amputation and that prosthetics lacked functionality, fine motor skills, sensation, and were costly (Figure 1).²

The team found that while 82% of in-depth interview participants did not feel pressured into pursuing UE VCA, 18% of participants felt “a little,” “somewhat,” “a lot,” or “completely” pressured to pursue UE VCA. Additionally, many participants reported that they recognized sources of potential pressure to pursue UE VCA. Most noted potential pressures from socio-cultural- and family-related sources, with some participants acknowledging potential pressure from the medical community.²

When participants were asked when they would have preferred to be informed about VCA as an alternative treatment option, study participants predominantly recommended that information disclosure about VCA be given early, in respect to the date of their UE amputation, such as before or days/weeks after UE surgery, or after the individual has healed physically and psychologically and no longer requires the use of pain medication. Participants also suggested providing information digitally (i.e., via a website) and in an easy-to-digest format, as the standard paper information packets can be difficult to manipulate without the use of two hands and may be overwhelming to an individual who recently had their UE amputated.²

The team then categorized the UE VCA information needs by major theme and subtheme. Topics with the highest frequency of questions from study participants included the surgical procedure, hospital stay and recovery period, rehabilitation, medication side effects, and functionality, sensation, and other outcomes. With these themes in mind, a 35-item UE VCA question prompt sheet (UE VCA-QPS) was developed to aid patients in determining whether VCA is an option they would choose to pursue. Importantly, when asked about the likelihood of using a UE VCA-QPS, up to 86% of participants reported being “completely” or “a lot” likely to use a QPS.¹

Taken together, this study highlights the need to better inform and prepare patients in decision making as well as the need for a standardized informed consent process for UE VCA. This study identified patient preferences for selection criteria including medical, social, and psychological characteristics, which may help transplant centers establish realistic UE VCA expectations for patients, and ultimately improve patient outcomes.³ Furthermore, this study identified patients’ perceptions of what makes UE VCA successful, including functional, psychosocial, clinical, and Quality of Life factors.⁴ Addressing these factors can aid informed consent discussions, inform the development of UE VCA patient-reported outcomes measures, and contribute to patient-centered clinical care. By providing access to patient-centered educational resources, such as the UE VCA-QPS, prior to or soon after undergoing UE amputation, patients may be able to make a more informed treatment decision. Ultimately, the team hopes this research may inform future research in other types of VCA organ programs to identify information needs and improve the decision-making process for patients.

The UE VCA-QPS can be downloaded from the team’s new educational website, Within Reach (www.WithinReach.info), which provides neutral, patient-centered information that may be a useful resource about UE VCA for individuals with UE amputations, their families, and health care professionals.⁵ Further, health care professionals may inform UE VCA candidates about Within Reach to supplement current VCA education processes. Ultimately, Within Reach serves as a resource about treatment options for patients preparing for scheduled, or recovering from, UE amputations.

References:

¹Gacki-Smith J, Kuramitsu B, Downey M, et al. Vanterpool K, Nordstrom MJ, Luken M, Riggleman T, Altema W, Fichter S, Cooney CM, Dumanian GA, Jensen SE, Brandacher G, Tintle S, Levan M, Gordon EJ. 2022. Information needs and development of a question prompt sheet for upper extremity vascularized composite allotransplantation: A mixed methods study. Special Issue on VCA. Frontiers in Psychology 2022; Sep 5;13:960373. doi: 10.3389/fpsyg.2022.960373.

²Gordon EJ, Gacki-Smith J, Kuramitsu B, et al. Downey MC, Vanterpool K, Nordstrom M, Riggleman T, Cooney CM, Jensen SE, Dumanian GA, Tintle S, Levan ML, Brandacher G.2023. Ethical and psychosocial factors in the decision-making and informed consent process for upper extremity vascularized composite allotransplantation: a mixed-methods study. Transplantation Direct 9(8): p e1515, August 2023.

³Vanterpool K, Gacki-Smith J, Downey MC, et al. 2023. Patient preferences of patient selection criteria for upper extremity vascularized composite allotransplantation: a qualitative study. SAGE Open Medicine Jun 15;11:20503121231181236.

⁴Downey MC, Gacki-Smith J, Kuramitsu B, et al. 2023. Patient definitions of transplant success in upper extremity vascularized composite allotransplantation: a mixed-methods study. SAGE Open Medicine Jul 13;11:20503121231184677.

⁵Vanterpool K, Gacki-Smith J, Kuramitsu B, et al. 2023. A patient-centered website (Within Reach) to foster informed decision-making about upper extremity vascularized composite allotransplantation: development and usability study. JMIR Formative Research 7:e44144. doi: 10.2196/44144

Links:

1. https://www.frontiersin.org/articles/10.3389/fpsyg.2022.960373/full

2. https://journals.lww.com/transplantationdirect/Fulltext/2023/08000/Ethical_and_Psychosocial_Factors_in_the.9.aspx

3. https://pubmed.ncbi.nlm.nih.gov/37342616/

4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10350745/

5. https://formative.jmir.org/2023/1/e44144

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