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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

Letter to the editor: Six-month antibody kinetics and durability in liver transplant recipients after two doses of SARS-CoV-2 mRNA vaccination [Letter]

Chang, Amy; Strauss, Alexandra T; Alejo, Jennifer L; Chiang, Teresa P-Y; Hernandez, Nicole F; Zeiser, Laura B; Boyarsky, Brian J; Avery, Robin K; Tobian, Aaron A R; Levan, Macey L; Warren, Daniel S; Garonzik-Wang, Jacqueline M; Massie, Allan B; Werbel, William A; Segev, Dorry L
PMID: 35791054
ISSN: 2471-254x
CID: 5280322

cDCDD-NRP is consistent with US legal standards for determining death

Adams, Bradley L; Brenner, Lauren; Levan, Macey; Parent, Brendan
Donation after circulatory determination of death (DCDD) has increased organ donation rates in the US over the past decade within an established legal framework, which is consistent with and supports individual and family decisions regarding organ donation in the context of end-of-life care. A new application, controlled DCDD donation utilizing thoracoabdominal normothermic regional perfusion (NRP) protocols (cDCDD-NRP), provides the opportunity to maximize a donation decision by recovering additional organs for transplant, including the heart, and to limit the detrimental impact of warm ischemic time by perfusing organs in situ following the declaration of circulatory death. In this viewpoint, we narrate our rationale for why cDCDD-NRP is consistent within the existing legal framework for organ donation in the United States and recommend no changes to the Uniform Determination of Death Act.
PMID: 35510751
ISSN: 1600-6143
CID: 5216322

Antibody response to a third dose of SARS-CoV-2 vaccine in heart and lung transplant recipients [Letter]

Alejo, Jennifer L; Ruck, Jessica M; Chiang, Teresa P Y; Abedon, Aura T; Kim, Jake D; Avery, Robin K; Tobian, Aaron A R; Warren, Daniel S; Levan, Macey L; Massie, Allan B; Garonzik-Wang, Jacqueline M; Segev, Dorry L; Werbel, William A
PMID: 36073912
ISSN: 1399-0012
CID: 5332532

Incidence and Severity of COVID-19 Among Vaccinated Solid Organ Transplant Recipients During the Omicron Wave

Alejo, Jennifer L; Chiang, Teresa P Y; Bowles Zeiser, Laura; Kim, Jake D; Mitchell, Jonathan; Avery, Robin K; Tobian, Aaron A R; Abedon, Rivka R; Levan, Macey L; Warren, Daniel S; Garonzik-Wang, Jacqueline M; Massie, Allan B; Segev, Dorry L; Werbel, William A
PMID: 35655363
ISSN: 1534-6080
CID: 5283552