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

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.

A Patient-Centered Website (Within Reach) to Foster Informed Decision-making About Upper Extremity Vascularized Composite Allotransplantation: Development and Usability Study.

BACKGROUND: Upper extremity (UE) vascularized composite allotransplantation (VCA; hand transplantation) is a reconstructive treatment option for patients with UE loss. Approximately 37 UE VCAs have been performed in the United States to date; thus, little is known about long-term psychosocial outcomes and whether the benefits outweigh the risks. To make an informed treatment decision, patients must understand the procedure, risks, and potential benefits of UE VCA. However, few educational resources are publicly available providing unbiased, comprehensive information about UE VCA. OBJECTIVE: This paper described the development of a neutral, and accessible, educational website supporting informed decision-making about UE VCA as a treatment option for individuals with UE amputations. METHODS: Website content development was informed by 9 focus groups conducted with individuals with UE amputations at 3 study sites. After initial website development, we conducted usability testing to identify ways to improve navigability, design, content, comprehension, and cultural sensitivity. Participants were administered the After-Scenario Questionnaire to assess user performance after completing navigational tasks, System Usability Scale to measure the perceived usability of the website, and Net Promoter Score to measure user satisfaction. Quantitative data were analyzed using descriptive statistics. Qualitative data were analyzed using rapid thematic analysis. RESULTS: A total of 44 individuals with UE amputations participated in focus groups (n=37, 84%) and usability testing (n=14, 32%). Most participants in the focus groups and usability testing were male (24/37, 65% and 11/14, 79%, respectively) and White (27/37, 73% and 9/14, 64%, respectively), had unilateral limb loss (22/37, 59% and 12/14, 86%, respectively), and had mean ages of 48 (SD 9.2) and 50 (SD 12.0) years, respectively. Focus group results are organized into accessibility, website design, website development, website tone and values, sitemap, terminology, images and videos, and tables and graphics. Usability testing revealed that participants had a positive impression of the website. The mean After-Scenario Questionnaire score of 1.3 to 2.3 across task scenarios indicated high satisfaction with website usability, the mean System Usability Scale score of 88.9 indicated user satisfaction with website usability, and the mean Net Promoter Score of 9.6 indicated that users were enthusiastic and would likely refer individuals to the website. CONCLUSIONS: The findings suggest that our educational website, Within Reach, provides neutral, patient-centered information and may be a useful resource about UE VCA for individuals with UE amputations, their families, and health care professionals. Health care professionals may inform UE VCA candidates about Within Reach to supplement current VCA education processes. Within Reach serves as a resource about treatment options for patients preparing for scheduled or recovering from traumatic UE amputations. Future research should assess whether Within Reach improves knowledge about UE VCA and enhances informed decision-making about UE VCA as a treatment option.

Information needs and development of a question prompt sheet for upper extremity vascularized composite allotransplantation: A mixed methods study.

Background: People with upper extremity (UE) amputations report receiving insufficient information about treatment options. Furthermore, patients commonly report not knowing what questions to ask providers. A question prompt sheet (QPS), or list of questions, can support patient-centered care by empowering patients to ask questions important to them, promoting patient-provider communication, and increasing patient knowledge. This study assessed information needs among people with UE amputations about UE vascularized composite allotransplantation (VCA) and developed a UE VCA-QPS. Methods: This multi-site, cross-sectional, mixed-methods study involved in-depth and semi-structured interviews with people with UE amputations to assess information needs and develop a UE VCA-QPS. Qualitative data were analyzed by thematic analysis; quantitative data were analyzed by descriptive statistics. The initial UE VCA-QPS included 130 items across 18 topics. Results: Eighty-nine people with UE amputations participated. Most were male (73%), had a mean age of 46 years, and had a unilateral (84%) and below-elbow amputation (56%). Participants desired information about UE VCA eligibility, evaluation process, surgery, risks, rehabilitation, and functional outcomes. After refinement, the final UE VCA-QPS included 35 items, across 9 topics. All items were written at a ≤ 6th grade reading level. Most semi-structured interview participants (86%) reported being 'completely' or 'very' likely to use a UE VCA-QPS. Conclusion: People with UE amputations have extensive information needs about UE VCA. The UE VCA-QPS aims to address patients' information needs and foster patient-centered care. Future research should assess whether the UE VCA-QPS facilitates patient-provider discussion and informed decision-making for UE VCA.

Monitoring at-home prosthesis control improvements through real-time data logging.

Objective.Validating the ability for advanced prostheses to improve function beyond the laboratory remains a critical step in enabling long-term benefits for prosthetic limb users.Approach.A nine week take-home case study was completed with a single participant with upper limb amputation and osseointegration to better understand how an advanced prosthesis is used during daily activities. The participant was already an expert prosthesis user and used the Modular Prosthetic Limb (MPL) at home during the study. The MPL was controlled using wireless electromyography (EMG) pattern recognition-based movement decoding. Clinical assessments were performed before and after the take-home portion of the study. Data was recorded using an onboard data log in order to measure daily prosthesis usage, sensor data, and EMG data.Main results.The participant's continuous prosthesis usage steadily increased (p= 0.04, max = 5.5 h) over time and over 30% of the total time was spent actively controlling the prosthesis. The duration of prosthesis usage after each pattern recognition training session also increased over time (p= 0.04), resulting in up to 5.4 h of usage before retraining the movement decoding algorithm. Pattern recognition control accuracy improved (1.2% per week,p< 0.001) with a maximum number of ten classes trained at once and the transitions between different degrees of freedom increased as the study progressed, indicating smooth and efficient control of the advanced prosthesis. Variability of decoding accuracy also decreased with prosthesis usage (p< 0.001) and 30% of the time was spent performing a prosthesis movement. During clinical evaluations, Box and Blocks and the Assessment of the Capacity for Myoelectric Control scores increased by 43% and 6.2%, respectively, demonstrating prosthesis functionality and the NASA Task Load Index scores decreased, on average, by 25% across assessments, indicating reduced cognitive workload while using the MPL, over the nine week study.Significance. In this case study, we demonstrate that an onboard system to monitor prosthesis usage enables better understanding of how prostheses are incorporated into daily life. That knowledge can support the long-term goal of completely restoring independence and quality of life to individuals living with upper limb amputation.

Extended home use of an advanced osseointegrated prosthetic arm improves function, performance, and control efficiency.

Objective.Full restoration of arm function using a prosthesis remains a grand challenge; however, advances in robotic hardware, surgical interventions, and machine learning are bringing seamless human-machine interfacing closer to reality.Approach.Through extensive data logging over 1 year, we monitored at-home use of the dexterous Modular Prosthetic Limb controlled through pattern recognition of electromyography (EMG) by an individual with a transhumeral amputation, targeted muscle reinnervation, and osseointegration (OI).Main results.Throughout the study, continuous prosthesis usage increased (1% per week,p< 0.001) and functional metrics improved up to 26% on control assessments and 76% on perceived workload evaluations. We observed increases in torque loading on the OI implant (up to 12.5% every month,p< 0.001) and prosthesis control performance (0.5% every month,p< 0.005), indicating enhanced user integration, acceptance, and proficiency. More importantly, the EMG signal magnitude necessary for prosthesis control decreased, up to 34.7% (p< 0.001), over time without degrading performance, demonstrating improved control efficiency with a machine learning-based myoelectric pattern recognition algorithm. The participant controlled the prosthesis up to one month without updating the pattern recognition algorithm. The participant customized prosthesis movements to perform specific tasks, such as individual finger control for piano playing and hand gestures for communication, which likely contributed to continued usage.Significance.This work demonstrates, in a single participant, the functional benefit of unconstrained use of a highly anthropomorphic prosthetic limb over an extended period. While hurdles remain for widespread use, including device reliability, results replication, and technical maturity beyond a prototype, this study offers insight as an example of the impact of advanced prosthesis technology for rehabilitation outside the laboratory.