Assessing LSAM's ability to account for changes in organ donation and transplant center behavior.

The Liver Simulated Allocation Model (LSAM) is used to evaluate proposed organ allocation policies. Although LSAM has been shown to predict the directionality of changes in transplants and nonused organs, the magnitude is often overestimated. One reason is that policymakers and researchers using LSAM assume static levels of organ donation and center behavior because of challenges with predicting future behavior. We sought to assess the ability of LSAM to account for changes in organ donation and organ acceptance behavior using LSAM 2019. We ran 1-year simulations with the default model and then ran simulations changing donor arrival rates (ie, organ donation) and center acceptance behavior. Changing the donor arrival rate was associated with a progressive simulated increase in transplants, with corresponding simulated decreases in waitlist deaths. Changing parameters related to organ acceptance was associated with important changes in transplants, nonused organs, and waitlist deaths in the expected direction in data simulations, although to a much lesser degree than changing the donor arrival rate. Increasing the donor arrival rate was associated with a marked decrease in the travel distance of donor livers in simulations. In conclusion, we demonstrate that LSAM can account for changes in organ donation and organ acceptance in a manner aligned with historical precedent that can inform future policy analyses. As Scientific Registry of Transplant Recipients develops new simulation programs, the importance of considering changes in donation and center practice is critical to accurately estimate the impact of new allocation policies.

What is visible is fixable: Visual dashboards for multi-domain assessment of organ procurement organization performance.

With stakeholder focus on the United States organ procurement system, there is a need for tools that permit comparative assessment of organ procurement providers. We developed a public-facing dashboard for organ procurement organizations (OPOs), using data from multiple sources, to create an online, readily accessible visualization of OPO practice conditions and performance for the period 2010-2020. With this tool, OPOs can be compared on the CMS metric of donors procured per 100 donation-consistent deaths, as well as donation after circulatory death procurement, procurement of older and minority patient populations, procurement in smaller hospitals, and procurement of patients without a significant drug history. Patterns of higher performance were identified, and 74% of differences in overall donor procurement rates could be explained using model variables. Procurement differences were affected to a greater and more reproducible degree by OPO performance among Black and non-White patient populations, as well as in smaller hospitals, than by donation service area characteristics. Dashboards such as ours support OPOs and stakeholders in quality improvement actions, through leveraging benchmarked performance data among organ procurement clinical providers.

Examining utilization of kidneys as a function of procurement performance.

Questions have arisen around new metrics for organ procurement organizations (OPO) due to the perception that low-performing OPOs may be limited by local centers' acceptance of marginal organs. We reviewed 2013-2019 Organ Procurement and Transplantation Network (OTPN) and National Centers for Health Statistics (NCHS) data to explore the relationship between objectively measured OPO performance and utilization of deceased donor kidneys. We found that although donor recovery declined with rising age and kidney donor profile index (KDPI), OPO performance differences were evident within each age/KDPI group. By contrast, the number of discards per donor did not vary with OPO performance. Centers in donor service areas (DSAs) with lower-performing OPOs had higher local utilization and greater import of high-KDPI kidneys than did those with higher-performing OPOs. Lower rates of donor availability relative to waitlist additions may contribute to observed center acceptance behavior. Differences in center-level performance were highly visible in Scientific Registry of Transplant Recipients (SRTR) organ acceptance metrics, while SRTR OPO metrics did not detect large or persistent variation in procurement performance. Cumulatively, our findings suggest that objective measures of procurement performance can inform discussions of organ utilization, allowing for alignment of metrics in all elements of the procurement-transplantation system.

Procurement characteristics of high- and low-performing OPOs as seen in OPTN/SRTR data.

To meet new Centers for Medicare and Medicaid Services (CMS) metrics, organ procurement organizations (OPOs) will benefit from understanding performance across decedent and hospital types. We sought to determine the utility of existing data-reporting structures for this purpose by reviewing Scientific Registry of Transplant Recipient (SRTR) OPO-Specific Reports (OSRs) from 2013 to 2019. OSRs contain both the Standardized donation rate ratio (SDRR) metric and OPO-reported numbers of "eligible deaths" and donors by hospital. Donor hospitals were characterized using information from Homeland Infrastructure Foundation-Level Data, Dartmouth Atlas Hospital Service Area data, and the US Census Bureau. Hospital data reported by OPOs showed 51% higher eligible death donors and 140% higher noneligible death donors per 100 inpatient beds in CMS ranked top versus bottom-quartile OPOs. Top-quartile OPOs by the CMS metric recovered 78% more donors than those in the bottom quartile, but were indistinguishable by SDRR rankings. These differences persisted across hospital sizes, trauma case mix, and area demographics. OPOs with divergent performance were indistinguishable over time by SDRR, but showed changes to hospital-level recovery patterns in SRTR data. Contemporaneous recognition of underperformance across hospitals may provide important and actionable data for regulators and OPOs for focused quality improvement projects.

Listing at non-local transplant centers is associated with increased access to deceased donor kidney transplantation.

The ability of kidney transplant candidates to travel outside of their usual place of care varies by sociodemographic factors, potentially exacerbating disparities in access. We used Transplant Referral Regions (TRRs) to overcome previous methodological barriers of using geographic distance to assess the characteristics and outcomes of patients listed for kidney transplant at centers in neighboring TRR or beyond neighboring TRRs. Among listed kidney transplant candidates, 20.9% traveled to a neighbor and 5.6% beyond a neighbor. A higher proportion of travelers were White, had some college education, and lived in ZIP codes with lower poverty. Travel to a neighbor was associated with a 7% increase in likelihood of deceased donor transplant (cHR: 1.07, 95% CI: 1.05, 1.09) and traveling beyond a neighbor with a 19% increase (cHR: 1.19, 95% CI: 1.15, 1.24). Travelers had similar rates of living donor transplant and waitlist mortality as patients who did not travel; those who traveled beyond a neighbor had slightly lower posttransplant mortality (HR: 0.91, 95% CI: 0.83, 0.99). In conclusion, the ability to travel outside of the recipient's assigned TRR increases access to transplantation and improves long-term survival.

Results of a data-driven performance improvement initiative in organ donation.

New metrics for organ procurement organization (OPO) performance utilize National Center for Health Statistics data to measure cause, age, and location consistent (CALC) deaths. We used this denominator to identify opportunities for improved donor conversion at one OPO, Indiana Donor Network (INOP). We sought to determine whether such analyses are immediately actionable for quality improvement (QI) initiatives directed at increased donor conversion. CALC-based assessment of INOP's performance revealed an opportunity to improve conversion of older donors. Following the QI initiative, INOP donor yield rose by 44%, while organs transplanted rose by 29%. These changes tolerated temporary disruption around the COVID-19 pandemic. Improved donor yield was primarily seen in older groups identified by CALC-based methods. Process changes in resource allocation and monitoring were associated with a 57% increase in the number of potential donors approached in the QI period and a subsequent rise in the number of potential donor referrals, suggesting positive feedback at area hospitals. Post-intervention, INOP's projected donation performance rose from 51st to 18th among all OPOs. OPOs can use CALC death data to accurately assess donor conversion by categories including age and race/ethnicity. These data can be used in real time to inform OPO-level processes to maximize donor recovery.

Public discourse and policy change: Absence of harm from increased oversight and transparency in OPO performance.

The Centers for Medicare and Medicaid Services announced changes to the Final Rule for organ procurement organizations (OPOs) in November 2020, after a 23-month period of public debate. One concern among transplant stakeholders was that public focus on OPO underperformance would harm deceased donation. Using CDC-WONDER data, we studied whether donation performance dropped during the era of public debate about OPO reform (December 2018-February 2020). Overall OPO performance as measured relative to cause, age, and location-consistent deaths rose by 12.3% in 2019, compared to a median annual change of 2.5% 2009-2019. Organ recoveries exceeded seasonally adjusted forecasts by 4.2% in the first half of 2019, by 8.1% following the Executive Order issuing a mandate for OPO metric reform, and by 14.1% between the Notice of Public Rule Making and the onset of COVID-19-related systemic disruptions. We describe changes in donor phenotype in the period of increased performance; improvement was greatest for older and donation after cardiac death (DCD) donors, and among decedents who did not have a drug-related mechanism of death. In summary, performance during an era of intense public debate and proposed regulatory changes yielded 692 additional donors over expectations, and no detriment to organ donation was observed.

Opportunity to increase deceased donation for United States veterans.

Recent changes to organ procurement organization (OPO) performance metrics have highlighted the need to identify opportunities to increase organ donation in the United States. Using data from the Organ Procurement and Transplantation Network (OPTN), Scientific Registry of Transplant Recipients (SRTR), and Veteran Health Administration Informatics and Computing Infrastructure Clinical Data Warehouse (VINCI CDW), we sought to describe historical donation performance at Veteran Administration Medical Centers (VAMCs). We found that over the period 2010-2019, there were only 33 donors recovered from the 115 VAMCs with donor potential nationwide. VA donors had similar age-matched organ transplant yields to non-VA donors. Review of VAMC records showed a total of 8474 decedents with causes of death compatible with donation, of whom 5281 had no infectious or neoplastic comorbidities preclusive to donation. Relative to a single state comparison of adult non-VA inpatient deaths, VAMC deaths were 20 times less likely to be characterized as an eligible death by SRTR. The rate of conversion of inpatient donation-consistent deaths without preclusive comorbidities to actual donors at VAMCs was 5.9% that of adult inpatients at non-VA hospitals. Overall, these findings suggest significant opportunities for growth in donation at VAMCs.

Utilization of deceased donors during a pandemic: argument against using SARS-CoV-2-positive donors.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become an unprecedented pandemic that has impacted society, disrupted hospital functions, strained health care resources, and impacted the lives of transplant professionals. Despite this, organ failure and the need for transplant continues throughout the United States. Considering the perpetual scarcity of deceased donor organs, Kates et al present a viewpoint that advocates for the utilization of coronavirus disease 2019 (COVID-19)-positive donors in selected cases. We present a review of the current literature that details the potential negative consequences of COVID-19-positive donors. The factors we consider include (1) the risk of blood transmission of SARS-CoV-2, (2) involvement of donor organs, (3) lack of effective therapies, (4) exposure of health care and recovery teams, (5) disease transmission and propagation, and (6) hospital resource utilization. While we acknowledge that transplant fulfills the mission of saving lives, it is imperative to consider the consequences not only to our recipients but also to the community and to health care workers, particularly in the absence of effective preventative or curative therapies. For these reasons, we believe the evidence and risks show that COVID-19 infection should continue to remain a contraindication for donation, as has been the initial response of donation and transplant societies.

Moving past "think local, act global": A perspective on geographic disparity.

The transplant community has debated the necessity and merits of broader organ distribution for several years, but the debate has been fundamentally shaped by inaccurate assessments of donor supply and demand. The possible legal requirements of distribution must be balanced with (a) the moral and statutory imperatives to reduce inequities resulting from socioeconomic disparity, and (b) the shortcomings of MELD in predicting mortality risk in rural areas. In this viewpoint, we use the example of liver transplantation to discuss the drivers of geographic disparity as a direct consequence of donation rates, local organ use, wealth, and poverty. Seen in this light, strategies seeking to equalize MELD at transplant across the United States risk severely exacerbating existing inequalities in access to health care.

Report from the American Society of Transplantation on frailty in solid organ transplantation.

A consensus conference on frailty in kidney, liver, heart, and lung transplantation sponsored by the American Society of Transplantation (AST) and endorsed by the American Society of Nephrology (ASN), the American Society of Transplant Surgeons (ASTS), and the Canadian Society of Transplantation (CST) took place on February 11, 2018 in Phoenix, Arizona. Input from the transplant community through scheduled conference calls enabled wide discussion of current concepts in frailty, exploration of best practices for frailty risk assessment of transplant candidates and for management after transplant, and development of ideas for future research. A current understanding of frailty was compiled by each of the solid organ groups and is presented in this paper. Frailty is a common entity in patients with end-stage organ disease who are awaiting organ transplantation, and affects mortality on the waitlist and in the posttransplant period. The optimal methods by which frailty should be measured in each organ group are yet to be determined, but studies are underway. Interventions to reverse frailty vary among organ groups and appear promising. This conference achieved its intent to highlight the importance of frailty in organ transplantation and to plant the seeds for further discussion and research in this field.

State-Based Liver Distribution: Broad Sharing With Less Harm to Vulnerable and Underserved Communities Compared With Concentric Circles.

Allocation of livers for transplantation faces regulatory pressure to move toward broader sharing. A current proposal supported by the United Network for Organ Sharing Board of Directors relies on concentric circles, but its effect on socioeconomic inequities in access to transplant services is poorly understood. In this article, we offer a proposal that uses the state of donation as a unit of distribution, given that the state is a recognized unit of legal jurisdiction and socioeconomic health in many contexts. The Scientific Registry of Transplant Recipients liver simulated allocation model algorithm was used to generate comparative estimates of regional transplant volume and the impact of these considered changes with regard to vulnerable and high-risk patients on the waiting list and to disparities in wait-list access. State-based liver distribution outperforms the concentric circle models in overall system efficiency, reduced discards, and minimized flights for organs. Furthermore, the efflux of organs from areas of greater sociodemographic vulnerability and lesser wait-list access is more than 2-fold lower in a state-based model than in concentric circle alternatives. In summary, we propose that a state-based system offers a legally defensible, practical, and ethically sound alternative to geometric zones of organ distribution.

Rural-Urban Differences in In-Hospital Mortality Among Admissions for End-Stage Liver Disease in the United States.

Access to quality hospital care is a persistent problem for rural patients. Little is known about disparities between rural and urban populations regarding in-hospital outcomes for end-stage liver disease (ESLD) patients. We aimed to determine whether rural ESLD patients experienced higher in-hospital mortality than urban patients and whether disparities were attributable to the rurality of the patient or the center. This was a retrospective study of patient admissions in the National Inpatient Sample, a population-based sample of hospitals in the United States. Admissions were included if they were from adult patients who had an ESLD-related admission defined by codes from the International Classification of Diseases, Ninth Revision, between January 2012 and December 2014. The primary exposures of interest were patient-level rurality and hospital-level rurality. The main outcome was in-hospital mortality. We stratified our analysis by disease severity score. After accounting for patient- and hospital-level covariates, ESLD admissions to rural hospitals in every category of disease severity had significantly higher odds of in-hospital mortality than patient admissions to urban hospitals. Those with moderate or major risk of dying had more than twice the odds of in-hospital mortality (odds ratio [OR] for moderate risk, 2.41; 95% confidence interval [CI], 1.62-3.59; OR for major risk, 2.49; 95% CI, 1.97-3.14). There was no association between patient-level rurality and mortality in the adjusted models. In conclusion, ESLD patients admitted to rural hospitals had increased odds of in-hospital mortality compared with those admitted to urban hospitals, and the differences were not attributable to patient-level rurality. Our results suggest that interventions to improve outcomes in this population should focus on the level of the health system.

Geographic inequity in transplant access.

PURPOSE OF REVIEW: Scarcity is a defining feature of the modern transplant landscape, and in light of chronic shortages in donor organs, there is cause for concern about geographic inequities in patients' access to lifesaving resources. Recent policy changes designed to ameliorate unequal donor supply and demand have brought new interest to measuring and addressing disparities at all stages of transplant care. The purpose of this review is to describe an overview of recent literature on geographic inequities in transplant access, focusing on kidney, liver, and lung transplantation and the impact of policy changes on organ allocation. RECENT FINDINGS: Despite a major change to the kidney allocation policy in 2014, geographic inequity in kidney transplant access remains. In liver transplantation, the debate has centered on the median acuity score at transplantation; however, a more thorough examination of disparities in access and survival has emerged. SUMMARY: Geographic differences in access and quality of transplant care are undeniable, but existing disparity metrics reflect disparities only among candidates who are waitlisted. Future research should address major gaps in our understanding of geographic inequity in transplant access, including patients who may be transplant-eligible but experience a wide variety of barriers in accessing the transplant waiting list.

Waitlist Hospital Admissions Predict Resource Utilization and Survival After Renal Transplantation.

OBJECTIVE: To determine whether fitness for transplant can be determined by candidates' hospitalizations although waitlisted. BACKGROUND: Renal transplantation must increasingly serve a population of multiply comorbid patients in an environment defined by organ scarcity and premiums on value-based care. Determining those at excess risk for transplant is critical to these imperatives. METHODS: United States Renal Data Systems patient and claims data for all adult renal transplant recipients between 2000 and 2010 with continuous primary Medicare coverage for 1 year before and after transplantation were examined. Outcomes included readmissions within the first-year post-transplant and 3-year graft and patient survival. Chi-square statistics, Kaplan-Meier methods (log-rank test), and goodness of fit calculations (c-statistics) were performed for models of transplant outcome. RESULTS: Among 37,623 patients, the percentages of patients admitted for 0, 1 to 7, 8 to 14, or 15 or more days in the pretransplant year were 51%, 25%, 11%, and 13%. Overall readmission-free survival at 1 year was 31%. Heavily preadmitted patients were more likely to have a greater length of stay during their transplant admission, and had a greater service needs at discharge. Pretransplant admission strongly predicted more frequent post-transplant admission. Among all factors studied, preadmission was the strongest predictor of post-transplant death, and had a dose-dependent effect on both death and graft loss. CONCLUSIONS: In summary, hospitalization in the year before transplant is an objective, readily ascertainable, and powerful predictor of excess resource utilization and inferior outcome. Incorporation of a rolling assessment of patient hospitalization has potential policy implications for maximizing value in renal transplantation.

County-level Differences in Liver-related Mortality, Waitlisting, and Liver Transplantation in the United States.

BACKGROUND: Much of our understanding regarding geographic issues in transplantation is based on statistical techniques that do not formally account for geography and is based on obsolete boundaries such as donation service area. METHODS: We applied spatial epidemiological techniques to analyze liver-related mortality and access to liver transplant services at the county level using data from the Centers for Disease Control and Prevention and Scientific Registry of Transplant Recipients from 2010 to 2018. RESULTS: There was a significant negative spatial correlation between transplant rates and liver-related mortality at the county level (Moran's I, -0.319; P = 0.001). Significant clusters were identified with high transplant rates and low liver-related mortality. Counties in geographic clusters with high ratios of liver transplants to liver-related deaths had more liver transplant centers within 150 nautical miles (6.7 versus 3.6 centers; P < 0.001) compared with all other counties, as did counties in geographic clusters with high ratios of waitlist additions to liver-related deaths (8.5 versus 2.5 centers; P < 0.001). The spatial correlation between waitlist mortality and overall liver-related mortality was positive (Moran's I, 0.060; P = 0.001) but weaker. Several areas with high waitlist mortality had some of the lowest overall liver-related mortality in the country. CONCLUSIONS: These data suggest that high waitlist mortality and allocation model for end-stage liver disease do not necessarily correlate with decreased access to transplant, whereas local transplant center density is associated with better access to waitlisting and transplant.