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

Vanterpool, Karen B; Gacki-Smith, Jessica; Kuramitsu, Brianna; Downey, Max; Nordstrom, Michelle J; Luken, Michelle; Riggleman, Tiffany; Fichter, Shannon; Altema, Withney; Brucker, James B; Cooney, Carisa M; Dumanian, Gregory; Jensen, Sally; Levan, Macey; Tintle, Scott M; Brandacher, Gerald; Gordon, Elisa J
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.
PMCID:9944141
PMID: 36749618
ISSN: 2561-326x
CID: 5480362

Transplantation Amid a Pandemic: The Fall and Rise of Kidney Transplantation in the United States

Bisen, Shivani S; Zeiser, Laura B; Boyarsky, Brian; Werbel, William; Snyder, Jon; Garonzik-Wang, Jacqueline; Levan, Macey L; Segev, Dorry L; Massie, Allan B
UNLABELLED:Following the outbreak of coronavirus disease 2019 (COVID-19) in the United States, the number of kidney waitlist additions and living-donor and deceased-donor kidney transplants (LDKT/DDKT) decreased substantially but began recovering within a few months. Since then, there have been several additional waves of infection, most notably, the Delta and Omicron surges beginning in August and December 2021, respectively. METHODS/UNASSIGNED:Using SRTR data, we compared observed waitlist registrations, waitlist mortality, waitlist removal due to deteriorating condition, LDKT, and DDKT over 5 distinct pandemic periods to expected events based on calculations from preepidemic data while accounting for seasonality and secular trends. RESULTS/UNASSIGNED:). CONCLUSIONS/UNASSIGNED:Despite exceptionally high COVID-19 incidence during the Omicron wave, the transplant system responded similarly to prior waves that imposed a lesser disease burden, demonstrating the transplant system's growing adaptations and resilience to this now endemic disease.
PMCID:9750630
PMID: 36582674
ISSN: 2373-8731
CID: 5480342

Patient definitions of transplant "success" of upper extremity VCA [Meeting Abstract]

Downey, M; Gacki-Smith, J; Kuramitsu, B; Vanterpool, K; Nordstrom, M; Luken, M; Riggleman, T; Fichter, S; Altema, W; Langlee, W; Cooney, C; Jensen, S; Dumanian, G; Levan, M; Tintle, S; Brandacher, G; Gordon, E
Introduction: Little is known about how to measure the "success" of upper extremity (UE) vascularized composite allotransplantation (VCA), an innovative treatment for people with UE amputations. While providers have defined UE VCA "success" by quantitative functional, clinical, and quality- of-life (QoL) metrics, patients' definitions are lesser known. Our study assessed patients' definitions of UE VCA "success." Methods: We conducted in-depth interviews and focus groups among people with acquired UE amputations and UE VCA candidates, participants, and recipients at three sites to assess transplant "success" and collect demographic data. Transcripts were analyzed using thematic analysis.
Result(s): We conducted 50 interviews (61.7% participation rate) and 9 focus groups among 37 participants (75.5% participation rate), including people with acquired UE amputations (83.3%), UE VCA candidates and participants (11.1%), and UE VCA recipients (5.6%). Most were male (73.6%), White (70.8%), had a mean age of 45 years, and had a unilateral (68.1%) and below-elbow amputation (51.4%). Transplant "success" was defined in 6 ways: 1) Restoring function and sensation to enable activities: "I can bring a glass to my lips and drink. I can open a door. . . I can drive my car" (functional/QoL); 2) Accepting the transplanted limb into the recipient's identity: ". . .if I can deal with living with it, knowing that it's not actually my hand" (psychosocial); 3) Surgical attachment of the donor limb to the recipient without rejection: "I'm leaning towards, came out of the surgery, and all the systems are connected" (clinical); 4) Ensuring that the benefits outweigh the risks: "The addition of the functionality would have to outweigh. . . the side-effects of the anti-rejection drugs" (functional/QoL); 5) Attaining better outcomes compared to prosthetics: ". . .if you [are] just having basically a useless limb hanging there. . . it'd be worse than your prosthetic" (functional/QoL).
Conclusion(s): Our findings suggest that participants have multiple definitions of UE VCA "success" pertaining to improvements in the recipient's daily living experience, compared to no treatment and/or prosthetics. Informed consent should address whether patients' desired outcomes can be realized with UE VCA
EMBASE:641391690
ISSN: 2050-3121
CID: 5514332

Empowering patients with upper extremity amputations to communicate with providers about VCA [Meeting Abstract]

Gacki-Smith, J; Kuramitsu, B; Downey, M; Vanterpool, K; Nordstrom, M; Luken, M; Riggleman, T; Altema, W; Fichter, S; Cooney, C; Dumanian, G; Jensen, S; Brandacher, G; Tintle, S; Levan, M; Gordon, E
Introduction: Patient-provider communication can be ineffective because many patients feel intimidated or do not know what questions to ask providers. Many individuals with upper extremity (UE) amputations do not receive sufficient information about their treatment options, particularly vascularized composite allotransplantation (VCA). A question prompt sheet (QPS) is a list of questions that can empower patients to ask questions they find important, promote patient-provider communication, and increase patient knowledge, thereby fostering patient-centered care. This study developed a UE VCA-QPS and examined the UE VCA information needs among people with UE amputations.
Method(s): We conducted a multi-site, cross-sectional, sequential mixed-methods study among people with acquired UE amputations. In-depth interviews were first conducted to examine patients' information needs about UE VCA, which were synthesized through qualitative content analysis into a list of items for the initial UE VCA-QPS draft. The initial draft UE VCA-QPS included 130 items across 18 topics. Thereafter, semi-structured interviews were conducted to rate the importance of each item for inclusion in the VCA-QPS and elicit qualitative rationales for each rating. Quantitative data were analyzed by descriptive statistics. The multidisciplinary research team reviewed the subsequent draft UE VCA-QPS to reduce the number of items, improve wording, remove repetitive items, and ensure that items were clinically relevant.
Result(s): Eighty-nine people participated (63.9% participation rate), including people who had not pursued UE VCA (85%), UE VCA candidates and participants (9%), and UE VCA recipients (6%). Most were male (73%), White (74%), and had a mean age of 46 years, had a unilateral (84%) and below-elbow amputation (56%). Participants expressed interest in learning about UE VCA eligibility, evaluation process, surgery, risks, rehabilitation, and functional outcomes. The final UE VCA-QPS included 35 items, organized into 9 topics. Items were written at a 6th grade reading level. Most semi-structured interview participants (86%) were 'completely' or 'very' likely to use a UE VCA-QPS. Discussion and
Conclusion(s): Our findings suggest that people with UE amputations desire much information about myriad aspects of UE VCA. Future research should assess whether the UE VCA-QPS helps to meet patients' information needs and foster informed decision-making for UE VCA
EMBASE:641391669
ISSN: 2050-3121
CID: 5514342

Patient definitions of transplant success in upper extremity vascularized composite allotransplantation: A mixed-methods study

Downey, Max C; Gacki-Smith, Jessica; Kuramitsu, Brianna; Vanterpool, Karen B; Nordstrom, Michelle; Luken, Michelle; Langlee, Whitney; Riggleman, Tiffany; Fichter, Shannon; Altema, Withney; Jensen, Sally E; Dumanian, Gregory A; Cooney, Carisa M; Levan, Macey L; Tintle, Scott; Brandacher, Gerald; Gordon, Elisa J
OBJECTIVE/UNASSIGNED:Upper extremity vascularized composite allotransplantation is an innovative treatment option for people with upper extremity amputations. Limited patient-relevant long-term outcomes data about transplant success may impede patients' informed treatment decision-making. We assessed perceptions of what constitutes upper extremity vascularized composite allotransplantation success among individuals with upper extremity amputations. METHODS/UNASSIGNED:This multisite study entailed interviews and focus groups with individuals with upper extremity amputations and upper extremity vascularized composite allotransplantation candidates, participants, and recipients. We examined perceptions of transplant success and preferences for five upper extremity vascularized composite allotransplantation outcomes. Qualitative data were analyzed using thematic analysis; and quantitative data were analyzed using descriptive statistics. RESULTS/UNASSIGNED:In all, 50 individuals participated in interviews (61.7% participation rate), and 37 participated in nine focus groups (75.5% participation rate). Most were White (72%, 73%), had a mean age of 45 and 48 years, and had a unilateral amputation (84%, 59%), respectively. Participants conceptualized upper extremity vascularized composite allotransplantation success as transplant outcomes: (1) restoring function and sensation to enable new activities; (2) accepting the transplanted limb into one's identity and appearance; (3) not having transplant rejection; (4) attaining greater quality of life compared to prosthetics; and (5) ensuring benefits outweigh risks. Participants rated their most important upper extremity vascularized composite allotransplantation outcomes as follows: not having transplant rejection, not developing health complications, grasping objects, feeling touch and temperature, and accepting the upper extremity vascularized composite allotransplantation into your identity. CONCLUSION/UNASSIGNED:Individuals with upper extremity amputations maintain several conceptions of vascularized composite allotransplantation success, spanning functional, psychosocial, clinical, and quality of life outcomes. Providers should address patients' conceptions of success to improve informed consent discussions and outcomes reporting for upper extremity vascularized composite allotransplantation.
PMCID:10350745
PMID: 37465724
ISSN: 2050-3121
CID: 5535712

Patient preferences of patient selection criteria for upper extremity vascularized composite allotransplantation: A qualitative study

Vanterpool, Karen B; Gacki-Smith, Jessica; Downey, Max C; Nordstrom, Michelle; Luken, Michelle; Riggleman, Tiffany; Fichter, Shannon; Altema, Withney; Jensen, Sally E; Dumanian, Gregory A; Cooney, Carisa M; Levan, Macey L; Tintle, Scott; Brandacher, Gerald; Gordon, Elisa J
BACKGROUND/UNASSIGNED:Upper extremity vascularized composite allotransplantation is a life-enhancing reconstructive treatment option that aims to improve recipients' quality of life and maximize function. This study assessed upper extremity vascularized composite allotransplantation patient selection criteria perceptions among individuals with upper extremity limb loss. The perceptions of individuals with upper extremity limb loss on patient selection criteria may enable vascularized composite allotransplantation centers to improve criteria to avoid mismatched expectations about the posttransplant vascularized composite allotransplantation experience and outcomes. Realistic patient expectations may increase patient adherence, improve outcomes, and reduce vascularized composite allotransplantation graft loss. METHODS/UNASSIGNED:We conducted in-depth interviews with civilian and military service members with upper extremity limb loss and upper extremity vascularized composite allotransplantation candidates, participants, and recipients from three US institutions. Interviews assessed perceptions of patient selection criteria for suitability as a candidate for upper extremity vascularized composite allotransplantation. Thematic analysis was used to analyze qualitative data. RESULTS/UNASSIGNED:A total of 50 individuals participated (66% participation rate). Most participants were male (78%), White (72%), with a unilateral limb loss (84%), and a mean age of 45 years. Six themes emerged regarding upper extremity vascularized composite allotransplantation patient selection criteria, including support for candidates who: (1) are of younger age, (2) are in good physical health, (3) have mental stability, (4) are willing to "put in the work," (5) have specific amputation characteristics, and (6) have sufficient social support. Patients had preferences about selecting candidates with unilateral versus bilateral limb loss. CONCLUSIONS/UNASSIGNED:Our findings suggest that numerous factors, including medical, social, and psychological characteristics, inform patients' perceptions of patient selection criteria for upper extremity vascularized composite allotransplantation. Patient perceptions of patient selection criteria should inform the development of validated screening measures that optimize patient outcomes.
PMCID:10278401
PMID: 37342616
ISSN: 2050-3121
CID: 5542722

Maximizing the use of potential donors through increased rates of family approach for authorization

Levan, Macey L; Massie, Allan B; Trahan, Chad; Hewlett, Jonathan; Strout, Tyler; Klitenic, Samantha B; Vanterpool, Karen B; Segev, Dorry L; Adams, Bradley L; Niles, Patricia
In the United States, a small proportion of potential deceased organ donor referrals lead to donation and recovery. Understanding variation in the processes involved between organ procurement organizations (OPOs) may help increase deceased donation and reduce the organ shortage. We studied 103 923 referrals from 10 OPOs from 2018 to 2019, of which 14.4% led to approach for authorization, 8.2% led to authorization, 5.1% led to organ recovery, and 4.8% led to transplantation. First-person authorization (FPA) was associated with threefold higher odds of donation (OR = 2.83 3.02 3.22 , p < .001). Female referrals had 11% lower odds of approach; when approached, Black and Hispanic referrals had 46% and 35% lower odds of authorization, respectively (all p < .001). There was substantial OPO-level variation in rates of approach, authorization, and organ recovery, which persisted after adjusting for age, sex, race, and FPA status. An OPO's relative rate of approach correlated strongly with its relative rate of donation among all referrals (ρ = 0.43). Correlation between an individual OPO's authorization rate among approached families, and overall rate of donation, was negative, suggesting that high authorization rates may be the result of selective approach practices. Therefore, approaching a higher proportion of families for authorization may lead to higher donation rates.
PMID: 36062407
ISSN: 1600-6143
CID: 5336932

Multicenter study of racial and ethnic inequities in liver transplantation evaluation: Understanding mechanisms and identifying solutions

Strauss, Alexandra T; Sidoti, Carolyn N; Purnell, Tanjala S; Sung, Hannah C; Jackson, John W; Levin, Scott; Jain, Vedant S; Malinsky, Daniel; Segev, Dorry L; Hamilton, James P; Garonzik-Wang, Jacqueline; Gray, Stephen H; Levan, Macey L; Scalea, Joseph R; Cameron, Andrew M; Gurakar, Ahmet; Gurses, Ayse P
Racial and ethnic disparities persist in access to the liver transplantation (LT) waiting list; however, there is limited knowledge about underlying system-level factors that may be responsible for these disparities. Given the complex nature of LT candidate evaluation, a human factors and systems engineering approach may provide insights. We recruited participants from the LT teams (coordinators, advanced practice providers, physicians, social workers, dieticians, pharmacists, leadership) at two major LT centers. From December 2020 to July 2021, we performed ethnographic observations (participant-patient appointments, committee meetings) and semistructured interviews (N = 54 interviews, 49 observation hours). Based on findings from this multicenter, multimethod qualitative study combined with the Systems Engineering Initiative for Patient Safety 2.0 (a human factors and systems engineering model for health care), we created a conceptual framework describing how transplant work system characteristics and other external factors may improve equity in the LT evaluation process. Participant perceptions about listing disparities described external factors (e.g., structural racism, ambiguous national guidelines, national quality metrics) that permeate the LT evaluation process. Mechanisms identified included minimal transplant team diversity, implicit bias, and interpersonal racism. A lack of resources was a common theme, such as social workers, transportation assistance, non-English-language materials, and time (e.g., more time for education for patients with health literacy concerns). Because of the minimal data collection or center feedback about disparities, participants felt uncomfortable with and unadaptable to unwanted outcomes, which perpetuate disparities. We proposed transplant center-level solutions (i.e., including but not limited to training of staff on health equity) to modifiable barriers in the clinical work system that could help patient navigation, reduce disparities, and improve access to care. Our findings call for an urgent need for transplant centers, national societies, and policy makers to focus efforts on improving equity (tailored, patient-centered resources) using the science of human factors and systems engineering.
PMCID:9796377
PMID: 35726679
ISSN: 1527-6473
CID: 5480312

6-month antibody kinetics and durability after four doses of a SARS-CoV-2 vaccine in solid organ transplant recipients [Letter]

Mitchell, Jonathan; Chiang, Teresa Py; Alejo, Jennifer L; Kim, Jake D; Chang, Amy; Abedon, Aura T; Avery, Robin K; Tobian, Aaron A R; Levan, Macey L; Warren, Daniel S; Garonzik-Wang, Jacqueline M; Segev, Dorry L; Massie, Allan B; Werbel, William A
PMID: 36437691
ISSN: 1399-0012
CID: 5383462

Predicting a Positive Antibody Response After 2 SARS-CoV-2 mRNA Vaccines in Transplant Recipients: A Machine Learning Approach With External Validation

Alejo, Jennifer L; Mitchell, Jonathan; Chiang, Teresa P-Y; Chang, Amy; Abedon, Aura T; Werbel, William A; Boyarsky, Brian J; Zeiser, Laura B; Avery, Robin K; Tobian, Aaron A R; Levan, Macey L; Warren, Daniel S; Massie, Allan B; Moore, Linda W; Guha, Ashrith; Huang, Howard J; Knight, Richard J; Gaber, Ahmed Osama; Ghobrial, Rafik Mark; Garonzik-Wang, Jacqueline M; Segev, Dorry L; Bae, Sunjae
BACKGROUND:Solid organ transplant recipients (SOTRs) are less likely to mount an antibody response to SARS-CoV-2 mRNA vaccines. Understanding risk factors for impaired vaccine response can guide strategies for antibody testing and additional vaccine dose recommendations. METHODS:Using a nationwide observational cohort of 1031 SOTRs, we created a machine learning model to explore, identify, rank, and quantify the association of 19 clinical factors with antibody responses to 2 doses of SARS-CoV-2 mRNA vaccines. External validation of the model was performed using a cohort of 512 SOTRs at Houston Methodist Hospital. RESULTS:Mycophenolate mofetil use, a shorter time since transplant, and older age were the strongest predictors of a negative antibody response, collectively contributing to 76% of the model's prediction performance. Other clinical factors, including transplanted organ, vaccine type (mRNA-1273 versus BNT162b2), sex, race, and other immunosuppressants, showed comparatively weaker associations with an antibody response. This model showed moderate prediction performance, with an area under the receiver operating characteristic curve of 0.79 in our cohort and 0.67 in the external validation cohort. An online calculator based on our prediction model is available at http://transplantmodels.com/covidvaccine/. CONCLUSIONS:Our machine learning model helps understand which transplant patients need closer follow-up and additional doses of vaccine to achieve protective immunity. The online calculator based on this model can be incorporated into transplant providers' practice to facilitate patient-centric, precision risk stratification and inform vaccination strategies among SOTRs.
PMID: 35859275
ISSN: 1534-6080
CID: 5279212