New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race.

BACKGROUND: Current equations for estimated glomerular filtration rate (eGFR) that use serum creatinine or cystatin C incorporate age, sex, and race to estimate measured GFR. However, race in eGFR equations is a social and not a biologic construct. METHODS: We developed new eGFR equations without race using data from two development data sets: 10 studies (8254 participants, 31.5% Black) for serum creatinine and 13 studies (5352 participants, 39.7% Black) for both serum creatinine and cystatin C. In a validation data set of 12 studies (4050 participants, 14.3% Black), we compared the accuracy of new eGFR equations to measured GFR. We projected the prevalence of chronic kidney disease (CKD) and GFR stages in a sample of U.S. adults, using current and new equations. RESULTS: In the validation data set, the current creatinine equation that uses age, sex, and race overestimated measured GFR in Blacks (median, 3.7 ml per minute per 1.73 m2 of body-surface area; 95% confidence interval [CI], 1.8 to 5.4) and to a lesser degree in non-Blacks (median, 0.5 ml per minute per 1.73 m2; 95% CI, 0.0 to 0.9). When the adjustment for Black race was omitted from the current eGFR equation, measured GFR in Blacks was underestimated (median, 7.1 ml per minute per 1.73 m2; 95% CI, 5.9 to 8.8). A new equation using age and sex and omitting race underestimated measured GFR in Blacks (median, 3.6 ml per minute per 1.73 m2; 95% CI, 1.8 to 5.5) and overestimated measured GFR in non-Blacks (median, 3.9 ml per minute per 1.73 m2; 95% CI, 3.4 to 4.4). For all equations, 85% or more of the eGFRs for Blacks and non-Blacks were within 30% of measured GFR. New creatinine-cystatin C equations without race were more accurate than new creatinine equations, with smaller differences between race groups. As compared with the current creatinine equation, the new creatinine equations, but not the new creatinine-cystatin C equations, increased population estimates of CKD prevalence among Blacks and yielded similar or lower prevalence among non-Blacks. CONCLUSIONS: New eGFR equations that incorporate creatinine and cystatin C but omit race are more accurate and led to smaller differences between Black participants and non-Black participants than new equations without race with either creatinine or cystatin C alone. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases.).

Advance Care Planning and Palliative Care Consultation in Kidney Transplantation.

RATIONALE & OBJECTIVE: Because of the high risk of waitlist mortality and posttransplant complications, kidney transplant (KT) patients may benefit from advance care planning (ACP) and palliative care consultation (PCC). We quantified the prevalence and racial disparities in ACP and PCC among KT candidates and recipients. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: 2,575 adult KT candidates and 1,233 adult recipients (2008-2020). EXPOSURE: Race and ethnicity. OUTCOMES: All reports of ACP and PCC were abstracted from chart review. ACP was defined as patient self-report of an advance directive, presence of an advance directive in the medical record, or a documented goals-of-care conversation with a provider. PCC was defined as an ordered referral or a documented palliative care note in the medical record. ANALYTICAL APPROACH: Racial/ethnic disparities in ACP/PCC were estimated using adjusted logistic regression. RESULTS: 21.4% of KT candidates and 34.9% of recipients engaged in ACP. There were racial/ethnic disparities in ACP among KT candidates (White, 24.4%; Black, 19.1%; Hispanic, 15%; other race and ethnicity, 21.1%; P=0.008) and recipients (White, 39.5%; Black, 31.2%; Hispanic, 26.3%; other race and ethnicity, 26.6%; P=0.007). After adjustment, Black KT recipients had a 29% lower likelihood of engaging in ACP (OR, 0.71; 95% CI, 0.55-0.91) than White KT recipients. Among older (aged≥65 years) recipients, those who were Black had a lower likelihood of engaging in ACP, but there was no racial disparity among younger recipients (P=0.020 for interaction). 4.2% of KT candidates and 5.1% of KT recipients engaged in PCC; there were no racial disparities in PCC among KT candidates (White, 5.3%; Black, 3.6%; Hispanic, 2.5%; other race and ethnicity, 2.1%; P=0.13) or recipients (White, 5.5%; Black, 5.6%; Hispanic, 0.0%; other race and ethnicity, 1.3%; P = 0.21). LIMITATIONS: Generalizability may be limited to academic transplant centers. CONCLUSIONS: ACP is not common among KT patients, and minoritized transplant patients are least likely to engage in ACP; PCC is less common. Future efforts should aim to integrate ACP and PCC into the KT process. PLAIN-LANGUAGE SUMMARY: Kidney transplant (KT) candidates and recipients are at elevated risk of morbidity and mortality. They may benefit from completing a document or conversation with their palliative care provider that outlines their future health care wishes, known as advance care planning (ACP), which is a component of palliative care consultation (PCC). We wanted to determine how many KT candidates and recipients have engaged in ACP or PCC and identify potential racial disparities. We found that 21.4% of candidates and 34.9% of recipients engaged in ACP. After adjustment, Black recipients had a 29% lower likelihood of engaging in ACP. We found that 4.2% of KT candidates and 5.1% of KT recipients engaged in PCC, with no racial disparities found in PCC.

Factors Informing High-Risk Primary Care Patient Choice around Telehealth Use: a Framework.

BACKGROUND: While telehealth's presence in post-pandemic primary care appears assured, its exact role remains unknown. Value-based care's expansion has heightened interest in telehealth's potential to improve uptake of preventive and chronic disease care, especially among high-risk primary care populations. Despite this, the pandemic underscored patients' diverse preferences around using telehealth. Understanding the factors underlying this population's preferences can inform future telehealth strategies. OBJECTIVE: To describe the factors informing high-risk primary care patient choice of whether to pursue primary care via telehealth, in-office or to defer care altogether. DESIGN: Qualitative, cross-sectional study utilizing semi-structured telephone interviews of a convenience sample of 29 primary care patients between July 13 and September 30, 2020. PARTICIPANTS: Primary care patients at high risk of poor health outcomes and/or acute care utilization who were offered a follow-up primary care visit via audiovisual, audio-only or in-office modalities. APPROACH: Responses were analyzed via grounded theory, using a constant comparison method to refine emerging categories, distinguish codes, and synthesize evolving themes. KEY RESULTS: Of the 29 participants, 16 (55.2%) were female and 19 (65.5%) were Black; the mean age (SD) was 64.6 (11.1). Participants identified four themes influencing their choice of visit type: perceived utility (encapsulating clinical and non-clinical utility), underlying costs (in terms of time, money, effort, and safety), modifiers (e.g., participants' clinical situation, choice availability, decision phenotype), and drivers (inclusive of their background experiences and digital environment). The relationship of these themes is depicted in a novel framework of patient choice around telehealth use. CONCLUSIONS: While visit utility and cost considerations are foundational to participants' decisions around whether to pursue care via telehealth, underappreciated modifiers and drivers often magnify or mitigate these considerations. Policymakers, payers, and health systems can leverage these factors to anticipate and enhance equitable high-value telehealth use in primary care settings among high-risk individuals.

Patients' Perspectives on Race and the Use of Race-Based Algorithms in Clinical Decision-Making: a Qualitative Study.

BACKGROUND: Clinical algorithms that incorporate race as a modifying factor to guide clinical decision-making have recently been criticized for propagating racial bias in medicine. Equations used to calculate lung or kidney function are examples of clinical algorithms that have different diagnostic parameters depending on an individual's race. While these clinical measures have multiple implications for clinical care, patients' awareness of and their perspectives on the application of such algorithms are unknown. OBJECTIVE: To examine patients' perspectives on race and the use of race-based algorithms in clinical decision-making. DESIGN: Qualitative study using semi-structured interviews. PARTICIPANTS: Twenty-three adult patients recruited at a safety-net hospital in Boston, MA. APPROACH: Interviews were analyzed using thematic content analysis and modified grounded theory. KEY RESULTS: Among the 23 study participants, 11 were women and 15 self-identified as Black or African American. Three categories of themes emerged: The first theme described definitions and the individual meanings participants ascribed to the term race. The second theme described perspectives on the role and consideration of race in clinical decision-making. Most study participants were unaware that race has been used as a modifying factor in clinical equations and rejected the incorporation of race in these equations. The third theme related to exposure to and experience of racism in healthcare settings. Experiences described by non-White participants ranged from microaggressions to overt acts of racism, including perceived racist encounters with healthcare providers. In addition, patients alluded to a deep mistrust in the healthcare system as a major barrier to equitable care. CONCLUSIONS: Our findings suggest that most patients are unaware of how race has been used to make risk assessments and guide clinical care. Further research on patients' perspectives is needed to inform the development of anti-racist policies and regulatory agendas as we move forward to combat systemic racism in medicine.

A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease.

BACKGROUND: In response to a national call for re-evaluation of the use of race in clinical algorithms, the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) established a Task Force to reassess inclusion of race in the estimation of glomerular filtration rate (GFR) in the United States and its implications for diagnosis and management of patients with, or at risk for, kidney diseases. PROCESS & DELIBERATIONS: The Task Force organized its activities over 10 months in phases to (1) clarify the problem and evidence regarding GFR estimating equations in the United States (described previously in an interim report), and, in this final report, (2) evaluate approaches to address use of race in GFR estimation, and (3) provide recommendations. We identified 26 approaches for the estimation of GFR that did or did not consider race and narrowed our focus, by consensus, to 5 of those approaches. We holistically evaluated each approach considering 6 attributes: assay availability and standardization; implementation; population diversity in equation development; performance compared with measured GFR; consequences to clinical care, population tracking, and research; and patient centeredness. To arrive at a unifying approach to estimate GFR, we integrated information and evidence from many sources in assessing strengths and weaknesses in attributes for each approach, recognizing the number of Black and non-Black adults affected. RECOMMENDATIONS: (1) For US adults (>85% of whom have normal kidney function), we recommend immediate implementation of the CKD-EPI creatinine equation refit without the race variable in all laboratories in the United States because it does not include race in the calculation and reporting, included diversity in its development, is immediately available to all laboratories in the United States, and has acceptable performance characteristics and potential consequences that do not disproportionately affect any one group of individuals. (2) We recommend national efforts to facilitate increased, routine, and timely use of cystatin C, especially to confirm estimated GFR in adults who are at risk for or have chronic kidney disease, because combining filtration markers (creatinine and cystatin C) is more accurate and would support better clinical decisions than either marker alone. If ongoing evidence supports acceptable performance, the CKD-EPI eGFR-cystatin C (eGFRcys) and eGFR creatinine-cystatin C (eGFRcr-cys_R) refit without the race variables should be adopted to provide another first-line test, in addition to confirmatory testing. (3) Research on GFR estimation with new endogenous filtration markers and on interventions to eliminate race and ethnic disparities should be encouraged and funded. An investment in science is needed for newer approaches that generate accurate, unbiased, and precise GFR measurement and estimation without the inclusion of race, and that promote health equity and do not generate disparate care. IMPLEMENTATION: This unified approach, without specification of race, should be adopted across the United States. High-priority and multistakeholder efforts should implement this solution.

Rationing, racism and justice: advancing the debate around 'colourblind' COVID-19 ventilator allocation.

Withholding or withdrawing life-saving ventilators can become necessary when resources are insufficient. In the USA, such rationing has unique social justice dimensions. Structural elements of dominant allocation frameworks simultaneously advantage white communities, and disadvantage Black communities-who already experience a disproportionate burden of COVID-19-related job losses, hospitalisations and mortality. Using the example of New Jersey's Crisis Standard of Care policy, we describe how dominant rationing guidance compounds for many Black patients prior unfair structural disadvantage, chiefly due to the way creatinine and life expectancy are typically considered.We outline six possible policy options towards a more just approach: improving diversity in decision processes, adjusting creatinine scores, replacing creatinine, dropping creatinine, finding alternative measures, adding equity weights and rejecting the dominant model altogether. We also contrast these options with making no changes, which is not a neutral default, but in separate need of justification, despite a prominent claim that it is simply based on 'objective medical knowledge'. In the regrettable absence of fair federal guidance, hospital and state-level policymakers should reflect on which of these, or further options, seem feasible and justifiable.Irrespective of which approach is taken, all guidance should be supplemented with a monitoring and reporting requirement on possible disparate impacts. The hope that we will be able to continue to avoid rationing ventilators must not stand in the way of revising guidance in a way that better promotes health equity and racial justice, both to be prepared, and given the significant expressive value of ventilator guidance.

Sequential organ failure assessment, ventilator rationing and evolving triage guidance: new evidence underlines the need to recognise and revise, unjust allocation frameworks.

We respond to recent comments on our proposal to improve justice in ventilator triage, in which we used as an example New Jersey's (NJ) publicly available and legally binding Directive Number 2020-03. We agree with Bernard Lo and Doug White that equity implications of triage frameworks should be continually reassessed, which is why we offered six concrete options for improvement, and called for monitoring the consequences of adopted triage models. We disagree with their assessment that we mis-characterised their Model Guidance, as included in the NJ Directive, in ways that undermine our conclusions. They suggest we erroneously described their model as a two-criterion allocation framework; that recognising other operant criterion reveals it 'likely mitigate[s] rather than exacerbate[s] racial disparities during triage', and allege that concerns about inequitable outcomes are 'without evidence'. We highlight two major studies robustly demonstrating why concerns about disparate outcomes are justified. We also show that White and Lo seek to retrospectively-and counterfactually-correct the version of the Model Guideline included in the NJ Directive. However, as our facsimile reproductions show, neither the alleged four-criteria form, nor other key changes, such as dropping the Sequential Organ Failure Assessment score, are found in the Directive. These points matter because (1) our conclusions hence stand, (2) because the public version of the Model Guidance had not been updated to reduce the risk of inequitable outcomes until June 2021 and (3) NJ's Directive still does not reflect these revisions, and, hence, represents a less equitable version, as acknowledged by its authors. We comment on broader policy implications and call for ways of ensuring accurate, transparent and timely updates for users of high-stakes guidelines.

Equitably Allocating Resources during Crises: Racial Differences in Mortality Prediction Models.

Rationale: Crisis standards of care (CSCs) guide critical care resource allocation during crises. Most recommend ranking patients on the basis of their expected in-hospital mortality using the Sequential Organ Failure Assessment (SOFA) score, but it is unknown how SOFA or other acuity scores perform among patients of different races. Objectives: To test the prognostic accuracy of the SOFA score and version 2 of the Laboratory-based Acute Physiology Score (LAPS2) among Black and white patients. Methods: We included Black and white patients admitted for sepsis or acute respiratory failure at 27 hospitals. We calculated the discrimination and calibration for in-hospital mortality of SOFA, LAPS2, and modified versions of each, including categorical SOFA groups recommended in a popular CSC and a SOFA score without creatinine to reduce the influence of race. Measurements and Main Results: Of 113,158 patients, 27,644 (24.4%) identified as Black. The LAPS2 demonstrated higher discrimination (area under the receiver operating characteristic curve [AUC], 0.76; 95% confidence interval [CI], 0.76-0.77) than the SOFA score (AUC, 0.68; 95% CI, 0.68-0.69). The LAPS2 was also better calibrated than the SOFA score, but both underestimated in-hospital mortality for white patients and overestimated in-hospital mortality for Black patients. Thus, in a simulation using observed mortality, 81.6% of Black patients were included in lower-priority CSC categories, and 9.4% of all Black patients were erroneously excluded from receiving the highest prioritization. The SOFA score without creatinine reduced racial miscalibration. Conclusions: Using SOFA in CSCs may lead to racial disparities in resource allocation. More equitable mortality prediction scores are needed.

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.

A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease.

BACKGROUND: In response to a national call for re-evaluation of the use of race in clinical algorithms, the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) established a Task Force to reassess inclusion of race in the estimation of GFR in the United States and its implications for diagnosis and management of patients with, or at risk for, kidney diseases. PROCESS DELIBERATIONS: The Task Force organized its activities over 10 months in phases to ( 1 ) clarify the problem and evidence regarding eGFR equations in the United States (described previously in an interim report), and, in this final report, ( 2 ) evaluate approaches to address use of race in GFR estimation, and ( 3 ) provide recommendations. We identified 26 approaches for the estimation of GFR that did or did not consider race and narrowed our focus, by consensus, to five of those approaches. We holistically evaluated each approach considering six attributes: assay availability and standardization; implementation; population diversity in equation development; performance compared with measured GFR; consequences to clinical care, population tracking, and research; and patient centeredness. To arrive at a unifying approach to estimate GFR, we integrated information and evidence from many sources in assessing strengths and weaknesses in attributes for each approach, recognizing the number of Black and non-Black adults affected. RECOMMENDATIONS: ( 1 ) For US adults (>85% of whom have normal kidney function), we recommend immediate implementation of the CKD-EPI creatinine equation refit without the race variable in all laboratories in the United States because it does not include race in the calculation and reporting, included diversity in its development, is immediately available to all laboratories in the United States, and has acceptable performance characteristics and potential consequences that do not disproportionately affect any one group of individuals. ( 2 ) We recommend national efforts to facilitate increased, routine, and timely use of cystatin C, especially to confirm eGFR in adults who are at risk for or have CKD, because combining filtration markers (creatinine and cystatin C) is more accurate and would support better clinical decisions than either marker alone. If ongoing evidence supports acceptable performance, the CKD-EPI eGFR-cystatin C (eGFRcys) and eGFR creatinine-cystatin C (eGFRcr-cys_R) refit without the race variables should be adopted to provide another first-line test, in addition to confirmatory testing. ( 3 ) Research on GFR estimation with new endogenous filtration markers and on interventions to eliminate race and ethnic disparities should be encouraged and funded. An investment in science is needed for newer approaches that generate accurate, unbiased, and precise GFR measurement and estimation without the inclusion of race, and that promote health equity and do not generate disparate care. IMPLEMENTATION: This unified approach, without specification of race, should be adopted across the United States. High-priority and multistakeholder efforts should implement this solution.

Association of Estimated GFR Calculated Using Race-Free Equations With Kidney Failure and Mortality by Black vs Non-Black Race.

Importance: At a given estimated glomerular filtration rate (eGFR), individuals who are Black have higher rates of mortality and kidney failure with replacement therapy (KFRT) compared with those who are non-Black. Whether the recently adopted eGFR equations without race preserve racial differences in risk of mortality and KFRT at a given eGFR is unknown. Objective: To assess whether eGFR equations with and without race and cystatin C document racial differences in risk of KFRT and mortality in populations including Black and non-Black participants. Design, Setting, and Participants: Retrospective individual-level data analysis of 62 011 participants from 5 general population and 3 chronic kidney disease (CKD) US-based cohorts with serum creatinine, cystatin C, and follow-up for KFRT and mortality from 1988 to 2018. Exposures: Chronic Kidney Disease Epidemiology Collaboration equation with serum creatinine (eGFRcr with and without race), cystatin C (eGFRcys without race), or both markers (eGFRcr-cys without race). Main Outcomes and Measures: The prevalence of decreased eGFR at baseline and hazard ratios of KFRT and mortality in Black vs non-Black participants were calculated, adjusted for age and sex. Analyses were performed within each cohort and with random-effect meta-analyses of the models. Results: Among 62 011 participants (20 773 Black and 41 238 non-Black; mean age, 63 years; 53% women), the prevalence ratio (95% CI; percent prevalences) of eGFR less than 60 mL/min/1.73 m2 comparing Black with non-Black participants was 0.98 (95% CI, 0.93-1.03; 11% vs 12%) for eGFRcr with race, 0.95 (95% CI, 0.91-0.98; 17% vs 18%) for eGFRcys, and 1.2 (95% CI, 1.2-1.3; 13% vs 11%) for eGFRcr-cys but was 1.8 (95% CI, 1.7-1.8; 15% vs 9%) for eGFRcr without race. During a mean follow-up of 13 years, 8% and 4% of Black and non-Black participants experienced KFRT and 34% and 39% died, respectively. Decreased eGFR was associated with significantly greater risk of both outcomes for all equations. At an eGFR of 60 mL/min/1.73 m2, the hazard ratios for KFRT comparing Black with non-Black participants were 2.8 (95% CI, 1.6-4.9) for eGFRcr with race, 3.0 (95% CI, 1.5-5.8) for eGFRcys, and 2.8 (95% CI, 1.4-5.4) for eGFRcr-cys vs 1.3 (95% CI, 0.8-2.1) for eGFRcr without race. The 5-year absolute risk differences for KFRT comparing Black with non-Black participants were 1.4% (95% CI, 0.2%-2.6%) for eGFRcr with race, 1.1% (95% CI, 0.2%-1.9%) for eGFRcys, and 1.3% (95% CI, 0%-2.6%) for eGFRcr-cys vs 0.37% (95% CI, -0.32% to 1.05%) for eGFRcr without race. Similar patterns were observed for mortality. Conclusions and Relevance: In this retrospective analysis of 8 US cohorts including Black and non-Black individuals, the eGFR equation without race that included creatinine and cystatin C, but not the eGFR equation without race that included creatinine without cystatin C, demonstrated racial differences in the risk of KFRT and mortality throughout the range of eGFR. The eGFRcr-cys equation may be preferable to the eGFRcr equation without race for assessing racial differences in the risk of KFRT and mortality associated with low eGFR.

Equitable hemodialysis for undocumented immigrant patients: prioritizing patient voices in care implementation.

Undocumented immigrant patients with kidney disease in the United States are rightfully gaining increased access to scheduled hemodialysis treatments. For health care systems that have transitioned from emergency to more consistent treatments, the impact of this care on patients' livelihood remains unknown. Cervantes and colleagues provide evidence to better understand patients' experiences following transitions to scheduled hemodialysis treatments. These data are invaluable to formulate future implementation strategies that prioritize patients' values and health equity.

Racial disparities in preemptive waitlisting and deceased donor kidney transplantation: Ethics and solutions.

Kidney transplantation prior to dialysis, known as "preemptive transplant," enables patients to live longer and avoid the substantial quality of life burdens due to chronic dialysis. Deceased donor kidneys are a public resource that ought to provide health benefits equitably. Unfortunately, White, better educated, and privately insured patients enjoy disproportionate access to preemptive transplantation using deceased donor kidneys. This problem has persisted for decades and is exacerbated by the first-come, first-served approach to kidney allocation for predialysis patients. In this Personal Viewpoint, we describe the diverse barriers to preemptive waitlisting and kidney transplant. The analysis focuses on healthcare system features that particularly disadvantage Black patients, such as the waitlisting eligibility criterion of a single glomerular filtration rate or creatinine clearance ≤20 ml/min, and neglect of wide variation in the rate of progression to end-stage kidney disease (ESKD) in allocating preemptive transplants. We propose initiatives to improve equity including: (1) standardization of waitlisting eligibility criteria related to kidney function; (2) aggressive education for clinicians about early transplant referral; (3) innovations in electronic medical record capabilities; and (4) rapid status 7 listing by centers. If those initiatives fail, the transplant field should consider eliminating preemptive waitlisting and transplantation with deceased donor kidneys.

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.

Effects of Neighborhood-level Data on Performance and Algorithmic Equity of a Model That Predicts 30-day Heart Failure Readmissions at an Urban Academic Medical Center.

BACKGROUND: Socioeconomic data may improve predictions of clinical events. However, owing to structural racism, algorithms may not perform equitably across racial subgroups. Therefore, we sought to compare the predictive performance overall, and by racial subgroup, of commonly used predictor variables for heart failure readmission with and without the area deprivation index (ADI), a neighborhood-level socioeconomic measure. METHODS AND RESULTS: We conducted a retrospective cohort study of 1316 Philadelphia residents discharged with a primary diagnosis of congestive heart failure from the University of Pennsylvania Health System between April 1, 2015, and March 31, 2017. We trained a regression model to predict the probability of a 30-day readmission using clinical and demographic variables. A second model also included the ADI as a predictor variable. We measured predictive performance with the Brier Score (BS) in a held-out test set. The baseline model had moderate performance overall (BS 0.13, 95% CI 0.13-0.14), and among White (BS 0.12, 95% CI 0.12-0.13) and non-White (BS 0.13, 95% CI 0.13-0.14) patients. Neither performance nor algorithmic equity were significantly changed with the addition of the ADI. CONCLUSIONS: The inclusion of neighborhood-level data may not reliably improve performance or algorithmic equity.

Examining the Potential Impact of Race Multiplier Utilization in Estimated Glomerular Filtration Rate Calculation on African-American Care Outcomes.

BACKGROUND: Advancing health equity entails reducing disparities in care. African-American patients with chronic kidney disease (CKD) have poorer outcomes, including dialysis access placement and transplantation. Estimated glomerular filtration rate (eGFR) equations, which assign higher eGFR values to African-American patients, may be a mechanism for inequitable outcomes. Electronic health record-based registries enable population-based examination of care across racial groups. OBJECTIVE: To examine the impact of the race multiplier for African-Americans in the CKD-EPI eGFR equation on CKD classification and care delivery. DESIGN: Cross-sectional study SETTING: Two large academic medical centers and affiliated community primary care and specialty practices. PARTICIPANTS: A total of 56,845 patients in the Partners HealthCare System CKD registry in June 2019, among whom 2225 (3.9%) were African-American. MEASUREMENTS: Exposures included race, age, sex, comorbidities, and eGFR. Outcomes were transplant referral and dialysis access placement. RESULTS: Of 2225 African-American patients, 743 (33.4%) would hypothetically be reclassified to a more severe CKD stage if the race multiplier were removed from the CKD-EPI equation. Similarly, 167 of 687 (24.3%) would be reclassified from stage 3B to stage 4. Finally, 64 of 2069 patients (3.1%) would be reassigned from eGFR > 20 ml/min/1.73 m2 to eGFR ≤ 20 ml/min/1.73 m2, meeting the criterion for accumulating kidney transplant priority. Zero of 64 African-American patients with an eGFR ≤ 20 ml/min/1.73 m2 after the race multiplier was removed were referred, evaluated, or waitlisted for kidney transplant, compared to 19.2% of African-American patients with eGFR ≤ 20 ml/min/1.73 m2 with the default CKD-EPI equation. LIMITATIONS: Single healthcare system in the Northeastern United States and relatively small African-American patient cohort may limit generalizability. CONCLUSIONS: Our study reveals a meaningful impact of race-adjusted eGFR on the care provided to the African-American CKD patient population.

Kidney Function Decline among Black Patients with Sickle Cell Trait and Sickle Cell Disease: An Observational Cohort Study.

BACKGROUND: Sickle cell trait and sickle cell disease are thought to be independent risk factors for CKD, but the trajectory and predictors of kidney function decline in patients with these phenotypes are not well understood. METHODS: Our multicenter, observational study used registry data (collected January 2005 through June 2018) and included adult black patients with sickle cell trait or disease (exposures) or normal hemoglobin phenotype (reference) status (ascertained by electrophoresis) and at least 1 year of follow-up and three eGFR values. We used linear mixed models to evaluate the difference in the mean change in eGFR per year. RESULTS: We identified 1251 patients with sickle cell trait, 230 with sickle cell disease, and 8729 reference patients, with a median follow-up of 8 years. After adjustment, eGFR declined significantly faster in patients with sickle cell trait or sickle cell disease compared with reference patients; it also declined significantly faster in patients with sickle cell disease than in patients with sickle cell trait. Male sex, diabetes mellitus, and baseline eGFR ≥90 ml/min per 1.73 m2 were associated with faster eGFR decline for both phenotypes. In sickle cell trait, low hemoglobin S and elevated hemoglobin A were associated with faster eGFR decline, but elevated hemoglobins F and A2 were renoprotective. CONCLUSIONS: Sickle cell trait and disease are associated with faster eGFR decline in black patients, with faster decline in sickle cell disease. Low hemoglobin S was associated with faster eGFR decline in sickle cell trait but may be confounded by concurrent hemoglobinopathies. Prospective and mechanistic studies are needed to develop best practices to attenuate eGFR decline in such patients.

Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial.

BACKGROUND: There are few studies of patient-facing decision aids that include supportive kidney care as an option. We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced CKD. METHODS: Participants (age ≥ 65 years with advanced CKD) were randomized to receive verbal or video education. Primary outcome was knowledge of supportive kidney care (score range 0-3). Secondary outcomes included preference for supportive kidney care, and satisfaction and acceptability of the video. RESULTS: Among all participants (n = 100), knowledge of supportive kidney care increased significantly after receiving education (p < 0.01); however, there was no difference between study arms (p = 0.68). There was no difference in preference for supportive kidney care between study arms (p = 0.49). In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of "No" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care. Most felt comfortable watching the video (96%), felt the content was helpful (96%), and would recommend the video to others (96%). CONCLUSIONS: Among older patients with advanced CKD, we did not detect a significant difference between an educational verbal script and a video decision aid in improving knowledge of supportive kidney care or preferences. However, patients who received video education reported high satisfaction and acceptability ratings. Future research will determine the effectiveness of a supportive kidney care video decision aid on real-world patient outcomes. TRIAL REGISTRATION: NCT02698722 (ClinicalTrials.gov).

Mortality and Hospitalizations among Sickle Cell Disease Patients with End-Stage Kidney Disease Initiating Dialysis.

BACKGROUND: Sickle cell disease (SCD) is the most common inherited hematological disorder and a well-described risk factor for end-stage kidney disease (ESKD). Mortality and hospitalizations among patients with SCD who develop ESKD remain understudied. Furthermore, prior studies focused only on SCD patients where ESKD was caused by SCD. We aimed to describe mortality and hospitalization risk in all SCD patients initiating dialysis and explore risk factors for mortality and hospitalization. METHODS: We performed a national observational cohort study of African American ESKD patients initiating dialysis (2000-2014) in facilities affiliated with a large dialysis provider. SCD was identified by diagnosis codes and matched to a reference population (non-SCD) by age, sex, dialysis initiation year, and geographic region of care. Sensitivity analyses were conducted by restricting to patients where SCD was recorded as the cause of ESKD. RESULTS: We identified 504 SCD patients (mean age: 47 ± 14 years; 48% females) and 1,425 reference patients (mean age: 46 ± 14 years; 49% females). The median follow-up was 2.4 (IQR 1.0-4.5) years. Compared to the reference, SCD was associated with higher mortality risk (hazard ratio 1.66; 95% confidence interval [CI]: 1.36-2.03) and higher hospitalization rates (incidence rate ratio 2.12; 95% CI: 1.88-2.38) in multivariable analyses. Exploratory multivariable mortality risk models showed the largest mortality risk attenuation with the addition of time-varying hemoglobin and high-dose erythropoietin, but the association of SCD with mortality remained significant. Sensitivity analyses (restricted to ESKD caused by SCD) also showed significant associations between SCD and mortality and hospitalizations, but with larger effect estimates. High-dose erythropoietin was associated with the highest risk for mortality and hospitalization in SCD. CONCLUSIONS: Among ESKD patients, SCD is associated with a higher risk for mortality and hospitalization, particularly in patients where SCD is identified as the cause of ESKD.

Caring for older patients with advanced chronic kidney disease and considering their needs: a qualitative study.

BACKGROUND: Older patients with advanced chronic kidney disease often do not understand treatment options for renal replacement therapy, conservative kidney management, and advance care planning. It is unclear whether both clinicians and patients have similar perspectives on these treatments and end-of-life care. Thus, the aim of this study was to explore clinician and patient/caregiver perceptions of treatments for end-stage renal disease and advance care planning. METHODS: This was a qualitative interview study of nephrologists (n = 8), primary care physicians (n = 8), patients (n = 10, ≥ 65 years and estimated glomerular filtration rate < 20), and their caregivers (n = 5). Interviews were conducted until thematic saturation was reached. Transcripts were transcribed using TranscribeMe. Using Nvivo 12, we identified key themes via narrative analysis. RESULTS: We identified three key areas in which nephrologists', primary care physicians', and patients' expectations and/or experiences did not align: 1) dialysis discussions; 2) dialysis decision-making; and 3) processes of advance care planning. Nephrologist felt most comfortable specifically managing renal disease whereas primary care physicians felt their primary role was to advocate for patients and lead advance care planning discussions. Patients and caregivers had many concerns about the impact of dialysis on their lives and did not fully understand advance care planning. Clinicians' perspectives were aligned with each other but not with patient/caregivers. CONCLUSIONS: Our findings highlight the differences in experiences and expectations between clinicians, patients, and their caregivers regarding treatment decisions and advance care planning. Despite clinician agreement on their responsibilities, patients and caregivers were unclear about several aspects of their care. Further research is needed to test feasible models of patient-centered education and communication to ensure that all stakeholders are informed and feel engaged.