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After 20 Years of Advocacy, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Finally Become Law

Levan, Macey L; Reich, David J; Segev, Dorry L L
PMID: 34342961
ISSN: 1534-6080
CID: 5127472

Outcomes of living liver donor candidate evaluations in the Living Donor Collective pilot registry

Kasiske, Bertram L; Ahn, Yoon Son; Conboy, Michael; Dew, Mary Amanda; Folken, Christian; Levan, Macey L; Humar, Abhi; Israni, Ajay K; Rudow, Dianne LaPointe; Trotter, James F; Massie, Allan B; Musgrove, Donald
BACKGROUND:To gather information on long-term outcomes after living donation, the Scientific Registry of Transplant Recipients (SRTR) conducted a pilot on the feasibility of establishing a comprehensive donor candidate registry. METHODS:A convenience sample of 6 US living liver donor programs evaluated 398 consecutive donor candidates in 2018, ending with the March 12, 2020, COVID-19 emergency. RESULTS:For 333/398 (83.7%), the donor or program decided whether to donate; 166/333 (49.8%) were approved, and 167/333 (50.2%) were not or opted out. Approval rates varied by program, from 27.0% to 63.3% (median, 46%; intraquartile range, 37.3-51.1%). Of those approved, 90.4% were white, 57.2% were women, 83.1% were < 50 years, and 85.5% had more than a high school education. Of 167 candidates, 131 (78.4%) were not approved or opted out because of: medical risk (10.7%); chronic liver disease risk (11.5%); psychosocial reasons (5.3%); candidate declined (6.1%); anatomical reasons increasing recipient risk (26.0%); recipient-related reasons (33.6%); finances (1.5%); or other (5.3%). CONCLUSIONS:A comprehensive national registry is feasible and necessary to better understand candidate selection and long-term outcomes. As a result, the US Health Resources and Services Administration asked SRTR to expand the pilot to include all US living donor programs.
PMID: 34342054
ISSN: 1399-0012
CID: 5150322

Factors enabling transplant program participation in the Scientific Registry of Transplant Recipients (SRTR) Living Donor Collective: A national survey

Lentine, Krista L; Dew, Mary Amanda; Xiao, Huiling; Wisniewski, Addie; Levan, Macey L; Al Ammary, Fawaz; Sharfuddin, Asif; Axelrod, David A; Waterman, Amy D; Kasiske, Bertram
BACKGROUND:The Scientific Registry of Transplant Recipients (SRTR) Living Donor Collective (LDC), the first effort to create a lifetime registry for living donor candidates in the United States, requires transplant programs to register donor candidates while the SRTR conducts follow-up. METHODS:To better understand facilitators and barriers to program participation, we conducted a brief electronic survey of U.S. transplant program staff from October 26, 2021 to December 17, 2021. RESULTS:We received 132 responses, with at least one response from 87 living donor programs (46 kidney programs, 33 kidney and liver programs, and eight liver programs alone). We found 86% of program representatives strongly agreed or agreed that funding adequate to cover the cost of data collection would facilitate LDC participation, 92% agreed or strongly agreed with importance of electronic data submission options, and 74% reported that elimination of requirements to submit duplicative pre-operative information to the Organ Procurement and Transplantation Network (OPTN) would be helpful. Other potentially enabling factors include reduction in duration of OPTN postdonation follow-up requirements, ease-of-use, protection from data use for regulation, adequate data security, and equity in data access. CONCLUSION:This survey identifies potential targets to strengthen participation in the effort to create a national living donor registry in the United States. Collaboration and investment to overcome barriers to LDC participation among transplant programs are vital to generate long-term data on living donation for donor candidates, donors, and patients in need of transplant.
PMID: 36622257
ISSN: 1399-0012
CID: 5480352

Factors impacting the medication "Adherence Landscape" for transplant patients

Bendersky, Victoria A; Saha, Amrita; Sidoti, Carolyn N; Ferzola, Alexander; Downey, Max; Ruck, Jessica M; Vanterpool, Karen B; Young, Lisa; Shegelman, Abigail; Segev, Dorry L; Levan, Macey L
BACKGROUND:Medication non-adherence contributes to post-transplant graft rejection and failure; however, limited knowledge about the reasons for non-adherence hinders the development of interventions to improve adherence. We conducted focus groups with solid organ transplant recipients regarding overlooked challenges in the process of transplant medication self-management and examined their adherence strategies and perceptions towards the post-transplant medication regimen. METHODS:We conducted four focus groups with n = 31 total adult transplant recipients. Participants had received kidney, liver, or combined liver/kidney transplant at Johns Hopkins Hospital between 2014 and 2019. Focus groups were audio-recorded and transcribed. Transcripts were analyzed inductively, using the constant comparative method. RESULTS:Responses generally fell into two major categories: (1) barriers to adherence and (2) "adherence landscape". We define the former as factors directly labeled as barriers to adherence by participants and the latter as factors that heavily influence the post-transplant medication self-management process. CONCLUSIONS:We propose a shift in the way healthcare providers and researchers, address the question of medication non-adherence. Rather than asking why patients are non-adherent, we suggest that constructing and understanding patients' "adherence landscape" will provide an optimal way to align the goals of patients and providers and boost health outcomes.
PMID: 36950850
ISSN: 1399-0012
CID: 5462852

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.
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.
PMID: 36582674
ISSN: 2373-8731
CID: 5480342

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.
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 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