Engineering Equity Into the Promise of Xenotransplantation.

Two of the greatest challenges facing kidney transplantation are the lack of donated organs and inequities in who receives a transplant. Xenotransplantation holds promise as a treatment approach that could solve the supply problem. Major advances in gene-editing procedures have enabled several companies to raise genetically engineered pigs for organ donation. These porcine organs lack antigens and have other modifications that should reduce the probability of immunological rejection when transplanted into humans. The US Food and Drug Administration and transplantation leaders are starting to chart a path to test xenotransplants in clinical trials and later integrate them into routine clinical care. Here we provide a framework that industry, regulatory authorities, payers, transplantation professionals, and patient groups can implement to promote equity during every stage in this process. We also call for immediate action. Companies developing xenotransplant technology should assemble patient advocacy boards to bring the concerns of individuals with end-stage kidney disease to the forefront. For trials, xenotransplantation companies should partner with transplant programs with substantial patient populations of racial and ethnic minority groups and that have reciprocal relationships with those communities. Those companies and transplant programs should reach out now to those communities to inform them about xenotransplantation and try to address their concerns. These actions have the potential to make these communities full partners in the promise of xenotransplantation.

Hospital Equity Rating Metrics-Promise, Pitfalls, and Perils.

This Viewpoint addresses several considerations regarding equity metrics across hospital regulatory and accrediting organizations and suggestions for improvement.

Albuminuria testing and nephrology care among insured US adults with chronic kidney disease: a missed opportunity.

BACKGROUND: In chronic kidney disease (CKD), assessment of both estimated glomerular filtration rate (eGFR) and albuminuria are necessary for stratifying risk and determining the need for nephrology referral. The Kidney Disease: Improving Global Outcomes clinical practice guidelines for CKD recommend nephrology referral for eGFR < 30 ml/min/1.73m2 or for urinary albumin/creatinine ratio ≥ 300 mg/g. METHODS: Using a national claims database of US patients covered by commercial insurance or Medicare Advantage, we identified patients with CKD who were actively followed in primary care. We examined receipt of nephrology care within 1 year among these patients according to their stage of CKD, classified using eGFR and albuminuria categories. Multivariable logistic regression was used to examine odds of receiving nephrology care by CKD category, adjusting for age, sex, race/ethnicity, diabetes, heart failure, and coronary artery disease. RESULTS: Among 291,155 patients with CKD, 55% who met guideline-recommended referral criteria had seen a nephrologist. Receipt of guideline-recommended nephrology care was higher among those with eGFR < 30 (64%; 11,330/17738) compared with UACR ≥300 mg/g (51%; 8789/17290). 59% did not have albuminuria testing. Those patients without albuminuria testing had substantially lower adjusted odds of recommended nephrology care (aOR 0.47 [0.43, 0.52] for eGFR < 30 ml/min/1.73m2). Similar patterns were observed in analyses stratified by diabetes status. CONCLUSIONS: Only half of patients meeting laboratory criteria for nephrology referral were seen by a nephrologist. Underutilization of albuminuria testing may be a barrier to identifying primary care patients at elevated kidney failure risk who may warrant nephrology referral.

Race and kidney function: The facts and fix amidst the fuss, fuzziness, and fiction.

Racial profiling and killings of Black persons in 2020 became a lightning rod to combat structural racism in health care. The use of race in clinical algorithms to assess kidney function spurred a passionate and intense debate. Understanding the facts, fuss, fuzziness and fiction is key to fixing the problem.

Trends in Chronic Kidney Disease Care in the US by Race and Ethnicity, 2012-2019.

Importance: Significant racial and ethnic disparities in chronic kidney disease (CKD) progression and outcomes are well documented, as is low use of guideline-recommended CKD care. Objective: To examine guideline-recommended CKD care delivery by race and ethnicity in a large, diverse population. Design, Setting, and Participants: In this serial cross-sectional study, adult patients with CKD that did not require dialysis, defined as a persistent estimated glomerular filtration rate less than 60 mL/min/1.73 m2 or a urine albumin-creatinine ratio of 30 mg/g or higher for at least 90 days, were identified in 2-year cross-sections from January 1, 2012, to December 31, 2019. Data from the OptumLabs Data Warehouse, a national data set of administrative and electronic health record data for commercially insured and Medicare Advantage patients, were used. Exposures: The independent variables were race and ethnicity, as reported in linked electronic health records. Main Outcomes and Measures: On the basis of guideline-recommended CKD care, the study examined care delivery process measures (angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker prescription for albuminuria, statin prescription, albuminuria testing, nephrology care for CKD stage 4 or higher, and avoidance of chronic nonsteroidal anti-inflammatory drug prescription) and care delivery outcome measures (blood pressure and diabetes control). Results: A total of 452 238 patients met the inclusion criteria (mean [SD] age, 74.0 [10.2] years; 262 089 [58.0%] female; a total of 7573 [1.7%] Asian, 49 970 [11.0%] Black, 15 540 [3.4%] Hispanic, and 379 155 [83.8%] White). Performance on process measures was higher among Asian, Black, and Hispanic patients compared with White patients for angiotensin-converting enzyme inhibitor and angiotensin II receptor blocker use (79.8% for Asian patients, 76.7% for Black patients, and 79.9% for Hispanic patients compared with 72.3% for White patients in 2018-2019), statin use (72.6% for Asian patients, 69.1% for Black patients, and 74.1% for Hispanic patients compared with 61.5% for White patients), nephrology care (64.8% for Asian patients, 72.9% for Black patients, and 69.4% for Hispanic patients compared with 58.3% for White patients), and albuminuria testing (53.9% for Asian patients, 41.0% for Black patients, and 52.6% for Hispanic patients compared with 30.7% for White patients). Achievement of blood pressure control to less than 140/90 mm Hg was similar or lower among Asian (71.8%), Black (63.3%), and Hispanic (69.8%) patients compared with White patients (72.9%). Achievement of diabetes control with hemoglobin A1c less than 7.0% was 50.1% in Asian patients, 49.3% in Black patients, and 46.0% in Hispanic patients compared with 50.3% for White patients. Conclusions and Relevance: Higher performance on CKD care process measures among Asian, Black, and Hispanic patients suggests that differences in medication prescription and diagnostic testing are unlikely to fully explain known disparities in CKD progression and kidney failure. Improving care delivery processes alone may be inadequate for reducing these disparities.

Reassessing the Inclusion of Race in Diagnosing Kidney Diseases: An Interim Report from the NKF-ASN Task Force.

For almost two decades, equations that use serum creatinine, age, sex, and race to eGFR have included "race" as Black or non-Black. Given considerable evidence of disparities in health and healthcare delivery in African American communities, some regard keeping a race term in GFR equations as a practice that differentially influences access to care and kidney transplantation. Others assert that race captures important non GFR determinants of serum creatinine and its removal from the calculation may perpetuate other disparities. The National Kidney Foundation (NKF) and American Society of Nephrology (ASN) established a task force in 2020 to reassess the inclusion of race in the estimation of GFR in the United States and its implications for diagnosis and subsequent management of patients with, or at risk for, kidney diseases. This interim report details the process, initial assessment of evidence, and values defined regarding the use of race to estimate GFR. We organized activities in phases: (1) clarify the problem and examine evidence, (2) evaluate different approaches to address use of race in GFR estimation, and (3) make recommendations. In phase one, we constructed statements about the evidence and defined values regarding equity and disparities; race and racism; GFR measurement, estimation, and equation performance; laboratory standardization; and patient perspectives. We also identified several approaches to estimate GFR and a set of attributes to evaluate these approaches. Building on evidence and values, the attributes of alternative approaches to estimate GFR will be evaluated in the next phases and recommendations will be made.

Reassessing the Inclusion of Race in Diagnosing Kidney Diseases: An Interim Report From the NKF-ASN Task Force.

For almost 2 decades, equations that use serum creatinine, age, sex, and race to estimate glomerular filtration rate (GFR) have included "race" as Black or non-Black. Given considerable evidence of disparities in health and health care delivery in African American communities, some regard keeping a race term in GFR equations as a practice that differentially influences access to care and kidney transplantation. Others assert that race captures important non-GFR determinants of serum creatinine and its removal from the calculation may perpetuate other disparities. The National Kidney Foundation (NKF) and American Society of Nephrology (ASN) established a task force in 2020 to reassess the inclusion of race in the estimation of GFR in the United States and its implications for diagnosis and subsequent management of patients with, or at risk for, kidney diseases. This interim report details the process, initial assessment of evidence, and values defined regarding the use of race to estimate GFR. We organized activities in phases: (1) clarify the problem and examine evidence, (2) evaluate different approaches to address use of race in GFR estimation, and (3) make recommendations. In phase 1, we constructed statements about the evidence and defined values regarding equity and disparities; race and racism; GFR measurement, estimation, and equation performance; laboratory standardization; and patient perspectives. We also identified several approaches to estimate GFR and a set of attributes to evaluate these approaches. Building on evidence and values, the attributes of alternative approaches to estimate GFR will be evaluated in the next phases and recommendations will be made.

Experiences of Latinx Individuals Hospitalized for COVID-19: A Qualitative Study.

Importance: Latinx individuals, particularly immigrants, are at higher risk than non-Latinx White individuals of contracting and dying from coronavirus disease 2019 (COVID-19). Little is known about Latinx experiences with COVID-19 infection and treatment. Objective: To describe the experiences of Latinx individuals who were hospitalized with and survived COVID-19. Design, Setting, and Participants: The qualitative study used semistructured phone interviews of 60 Latinx adults who survived a COVID-19 hospitalization in public hospitals in San Francisco, California, and Denver, Colorado, from March 2020 to July 2020. Transcripts were analyzed using qualitative thematic analysis. Data analysis was conducted from May 2020 to September 2020. Main Outcomes and Measures: Themes and subthemes that reflected patient experiences. Results: Sixty people (24 women and 36 men; mean [SD] age, 48 [12] years) participated. All lived in low-income areas, 47 participants (78%) had more than 4 people in the home, and most (44 participants [73%]) were essential workers. Four participants (9%) could work from home, 12 (20%) had paid sick leave, and 21 (35%) lost their job because of COVID-19. We identified 5 themes (and subthemes) with public health and clinical care implications: COVID-19 was a distant and secondary threat (invincibility, misinformation and disbelief, ingrained social norms); COVID-19 was a compounder of disadvantage (fear of unemployment and eviction, lack of safeguards for undocumented immigrants, inability to protect self from COVID-19, and high-density housing); reluctance to seek medical care (worry about health care costs, concerned about ability to access care if uninsured or undocumented, undocumented immigrants fear deportation); health care system interactions (social isolation and change in hospital procedures, appreciation for clinicians and language access, and discharge with insufficient resources or clinical information); and faith and community resiliency (spirituality, Latinx COVID-19 advocates). Conclusions and Relevance: In interviews, Latinx patients with COVID-19 who survived hospitalization described initial disease misinformation and economic and immigration fears as having driven exposure and delays in presentation. To confront COVID-19 as a compounder of social disadvantage, public health authorities should mitigate COVID-19-related misinformation, immigration fears, and challenges to health care access, as well as create policies that provide work protection and address economic disadvantages.

Allocation of National Institutes of Health Funding by Disease Category in 2008 and 2019.

Importance: Prior research suggests an association between burden of disease and National Institutes of Health (NIH) funding. The allocation of NIH funding should reflect, to some extent, the health needs of the population, along with other factors. Objective: To examine the factors associated with NIH funding in 2019 for 46 diseases. Design, Setting, and Participants: This cohort study used disability-adjusted life-years to measure the 2008 and 2019 US burden of disease and compared them with NIH categoric funding for 46 diseases. Exposures: Disability-adjusted life-years to measure the 2008 and 2019 US burden of disease, 2016 health spending, and 2008 NIH funding levels for 46 diseases. Main Outcomes and Measures: 2019 NIH funding levels for 46 diseases. Results: The 46 diseases accounted for 62 392 713 of 94 399 784 disability-adjusted life-years (66.1%) in 2008 and 75 706 718 of 111 074 472 disability-adjusted life-years (68.2%) in 2019, representing more than 66% of all disability-adjusted life-years in both years. By dollar volume, Alzheimer and dementia increased the most, with approximately $1.8 billion more funding in 2019 than 2008 (from $530 million in 2008 to $2398 million in 2019, a 352% increase), whereas interpersonal violence had the greatest decrease, $95 million, in 2019 NIH funding (from $236 million in 2008 to $141 million in 2019, a 40% decrease). For the 46 diseases in this study, the variable with the greatest association with NIH funding in 2019 was the level of NIH funding in 2008, with a simple correlation of 0.88. Burden of disease and changes in burden of disease were not statistically significantly associated with NIH funding levels once the prior level of funding was included in the model. The models suggested that a 1% higher level of NIH funding in 2008 was associated with a 0.91% higher level of NIH funding in 2019. Conclusions and Relevance: In this study, NIH spending for most diseases seemed to be based primarily on the level of NIH spending more than 10 years earlier, despite changes in burden of disease. Congress and the NIH should examine the allocation process to ensure NIH investments are responsive to changes in the health of the population.