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Development of a Patient Reported Measure of Experimental Transplants with HIV and Ethics in the United States (PROMETHEUS)

Seaman, Shanti; Brown, Diane; Eno, Ann; Yu, Sile; Massie, Allan B; Tobian, Aaron A R; Durand, Christine M; Segev, Dorry L; Wu, Albert W; Sugarman, Jeremy
BACKGROUND:Transplantation of HIV-positive (HIV+) donor organs for HIV+ recipients (HIV D+/R+) is now being performed as research in the United States, but raises ethical concerns. While patient-reported outcome measures are increasingly used to evaluate clinical interventions, there is no published measure to aptly capture patients' experiences in the unique context of experimental HIV D+/R+ transplantation. Therefore, we developed PROMETHEUS (patient-reported measure of experimental transplants with HIV and ethics in the United States). To do so, we created a conceptual framework, drafted a pilot battery using existing and new measures related to this context, and refined it based on cognitive and pilot testing. PROMETHEUS was administered 6-months post-transplant in a clinical trial evaluating these transplants. We analyzed data from the first 20 patient-participants for reliability and validity by calculating Cronbach's alpha and reviewing item performance characteristics. RESULTS:PROMETHEUS 1.0 consisted of 29 items with 5 putative subscales: Emotions; Trust; Decision Making; Transplant; and Decision Satisfaction. Overall, responses were positive. Cronbach's alpha was > 0.8 for all subscales except Transplant, which was 0.38. Two Transplant subscale items were removed due to poor reliability and construct validity. CONCLUSIONS:We developed PROMETHEUS to systematically capture patient-reported experiences with this novel experimental transplantation program, nested it in an actual clinical trial, and obtained preliminary data regarding its performance.
PMCID:7973329
PMID: 33738660
ISSN: 2509-8020
CID: 5127042

Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients

Boyarsky, Brian J; Werbel, William A; Avery, Robin K; Tobian, Aaron A R; Massie, Allan B; Segev, Dorry L; Garonzik-Wang, Jacqueline M
PMID: 33720292
ISSN: 1538-3598
CID: 5127032

Examination of Racial and Ethnic Differences in Deceased Organ Donation Ratio Over Time in the US

Kernodle, Amber B; Zhang, Wanying; Motter, Jennifer D; Doby, Brianna; Liyanage, Luckmini; Garonzik-Wang, Jacqueline; Jackson, Kyle R; Boyarsky, Brian J; Massie, Allan B; Purnell, Tanjala S; Segev, Dorry L
Importance:Historically, deceased organ donation was lower among Black compared with White populations, motivating efforts to reduce racial disparities. The overarching effect of these efforts in Black and other racial/ethnic groups remains unclear. Objective:To examine changes in deceased organ donation over time. Design, Setting, and Participants:This population-based cohort study used data from January 1, 1999, through December 31, 2017, from the Scientific Registry of Transplant Recipients to quantify the number of actual deceased organ donors, and from the Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research Detailed Mortality File to quantify the number of potential donors (individuals who died under conditions consistent with organ donation). Data were analyzed from December 2, 2019, to May 14, 2020. Exposures:Race and ethnicity of deceased and potential donors. Main Outcomes and Measures:For each racial/ethnic group and year, a donation ratio was calculated as the number of actual deceased donors divided by the number of potential donors. Direct age and sex standardization was used to allow for group comparisons, and Poisson regression was used to quantify changes in donation ratio over time. Results:A total of 141 534 deceased donors and 5 268 200 potential donors were included in the analysis. Among Black individuals, the donation ratio increased 2.58-fold from 1999 to 2017 (yearly change in adjusted incidence rate ratio [aIRR], 1.05; 95% CI, 1.05-1.05; P < .001). This increase was significantly greater than the 1.60-fold increase seen in White individuals. Nevertheless, substantial racial differences remained, with Black individuals still donating at only 69% the rate of White individuals in 2017 (P < .001). Among other racial minority populations, changes were less drastic. Deceased organ donation increased 1.80-fold among American Indian/Alaska Native and 1.40-fold among Asian or Pacific Islander populations, with substantial racial differences remaining in 2017 (American Indian/Alaska Native population donation at 28% and Asian/Pacific Islander population donation at 85% the rate of the White population). Deceased organ donation differences between Hispanic/Latino and non-Hispanic/Latino populations increased over time (4% lower in 2017). Conclusions and Relevance:The findings of this cohort study suggest that differences in deceased organ donation between White and some racial minority populations have attenuated over time. The greatest gains were observed among Black individuals, who have been the primary targets of study and intervention. Despite improvements, substantial differences remain, suggesting that novel approaches are needed to understand and address relatively lower rates of deceased organ donation among all racial minorities.
PMCID:7876622
PMID: 33566079
ISSN: 2168-6262
CID: 5126972

Early Development and Durability of SARS-CoV-2 Antibodies Among Solid Organ Transplant Recipients: A Pilot Study

Boyarsky, Brian J; Ou, Michael T; Werbel, William A; Avery, Robin K; Clarke, William A; Tobian, Aaron A R; Massie, Allan B; Segev, Dorry L; Garonzik Wang, Jacqueline M
PMCID:8085060
PMID: 33617174
ISSN: 1534-6080
CID: 5126982

Safety of the First Dose of SARS-CoV-2 Vaccination in Solid Organ Transplant Recipients [Letter]

Boyarsky, Brian J; Ou, Michael T; Greenberg, Ross S; Teles, Aura T; Werbel, William A; Avery, Robin K; Massie, Allan B; Segev, Dorry L; Garonzik-Wang, Jacqueline M
PMCID:8084895
PMID: 33560728
ISSN: 1534-6080
CID: 5126962

Response to "COVID-19 in SOT versus non-SOT" [Comment]

Avery, Robin K; Chiang, Teresa P-Y; Marr, Kieren A; Garonzik-Wang, Jacqueline; Segev, Dorry L; Massie, Allan B
PMID: 33560556
ISSN: 1600-6143
CID: 5126952

Trends in Heart and Lung Transplantation in the United States Across the COVID-19 Pandemic

Hallett, Andrew; Motter, Jennifer D; Frey, Alena; Higgins, Robert S; Bush, Errol L; Snyder, Jon; Garonzik-Wang, Jacqueline M; Segev, Dorry L; Massie, Allan B
The coronavirus disease 2019 (COVID-19) pandemic has had a variable course across the United States. Understanding its evolving impact on heart and lung transplantation (HT and LT) will help with planning for next phases of this pandemic as well as future ones.
PMCID:8425844
PMID: 34514114
ISSN: 2373-8731
CID: 5127642

Pretransplant Hepatitis C Virus Treatment Decreases Access to High-quality Livers

Strauss, Alexandra T; Ishaque, Tanveen; Weeks, Sharon; Hamilton, James P; Simsek, Cem; Durand, Christine M; Massie, Allan B; Segev, Dorry L; Gurakar, Ahmet; Garonzik-Wang, Jacqueline M
Background/UNASSIGNED:Despite the revolutionary role of direct-acting antivirals for hepatitis C virus (HCV), the treatment timing for liver transplant candidates remains controversial. We hypothesize that deferring treatment until after liver transplantation improves access to a larger and higher-quality donor pool without a detrimental impact on post-liver transplantation outcomes. Methods/UNASSIGNED:This single-center study includes recipients that underwent deceased-donor liver transplant with HCV as the primary indication January 1, 2014, to December 31, 2018. For recipients that were untreated (n = 87) versus treated (n = 42) pre-LT, we compared post-LT mortality using Cox regression with inverse probability of treatment-weighted data. Results/UNASSIGNED: = 0.06). Conclusions/UNASSIGNED:Deferring HCV treatment improves access to higher-quality donors and may improve post-LT survival.
PMCID:8440014
PMID: 34549082
ISSN: 2373-8731
CID: 5127662

Characterizing the landscape and impact of infections following kidney transplantation

Jackson, Kyle R; Motter, Jennifer D; Bae, Sunjae; Kernodle, Amber; Long, Jane J; Werbel, William; Avery, Robin; Durand, Christine; Massie, Allan B; Desai, Niraj; Garonzik-Wang, Jacqueline; Segev, Dorry L
Infections remain a major threat to successful kidney transplantation (KT). To characterize the landscape and impact of post-KT infections in the modern era, we used United States Renal Data System (USRDS) data linked to the Scientific Registry of Transplant Recipients (SRTR) to study 141 661 Medicare-primary kidney transplant recipients from January 1, 1999 to December 31, 2014. Infection diagnoses were ascertained by International Classification of Diseases, Ninth Revision (ICD-9) codes. The cumulative incidence of a post-KT infection was 36.9% at 3 months, 53.7% at 1 year, and 78.0% at 5 years. The most common infections were urinary tract infection (UTI; 46.8%) and pneumonia (28.2%). Five-year mortality for kidney transplant recipients who developed an infection was 24.9% vs 7.9% for those who did not, and 5-year death-censored graft failure (DCGF) was 20.6% vs 10.1% (P < .001). This translated to a 2.22-fold higher mortality risk (adjusted hazard ratio [aHR]: 2.15 2.222.29 , P < .001) and 1.92-fold higher DCGF risk (aHR: 1.84 1.911.98 , P < .001) for kidney transplant recipients who developed an infection, although the magnitude of this higher risk varied across infection types (for example, 3.11-fold higher mortality risk for sepsis vs 1.62-fold for a UTI). Post-KT infections are common and substantially impact mortality and DCGF, even in the modern era. Kidney transplant recipients at high risk for infections might benefit from enhanced surveillance or follow-up to mitigate these risks.
PMID: 32506639
ISSN: 1600-6143
CID: 5126422

Effects of COVID-19 pandemic on pediatric kidney transplant in the United States

Charnaya, Olga; Chiang, Teresa Po-Yu; Wang, Richard; Motter, Jennifer D; Boyarsky, Brian J; King, Elizabeth A; Werbel, William A; Durand, Christine M; Avery, Robin K; Segev, Dorry L; Massie, Allan B; Garonzik-Wang, Jacqueline M
BACKGROUND:In March 2020, COVID-19 infections began to rise exponentially in the USA, placing substantial burden on the healthcare system. As a result, there was a rapid change in transplant practices and policies, with cessation of most procedures. Our goal was to understand changes to pediatric kidney transplantation (KT) at the national level during the COVID-19 epidemic. METHODS:Using SRTR data, we examined changes in pediatric waitlist registration, waitlist removal or inactivation, and deceased donor and living donor (DDKT/LDKT) events during the start of the disease transmission in the USA compared with the same time the previous year. RESULTS:) in states with high vs. low COVID activity. Transplant recipients during the pandemic were more likely to have received a DDKT, but had similar calculated panel-reactive antibody (cPRA) values, waitlist time, and cause of kidney failure as before the pandemic. CONCLUSIONS:The COVID-19 pandemic initially reduced access to kidney transplantation among pediatric patients in the USA but has not had a sustained effect.
PMID: 32980942
ISSN: 1432-198x
CID: 5126712