Race-Based Coefficients Used in the Diagnosis of Chronic Kidney Disease: A discussion and call to action

Current Landscape of the Problem?

?More than one in seven adults in the United States are estimated to have Chronic Kidney? Disease (CKD).1 According to the National Institute of Diabetes and Digestive and Kidney? Diseases,

“African Americans are almost four times as likely as Whites to develop kidney? failure.2”

It is undeniable that on a population-wide scale, Black individuals are at higher risk of some diseases than their non-Black counterparts. These differences in risk are attributable to a multitude of factors, including but not limited to differences in genetics, access to healthcare,?socioeconomic status, education, and systemized racism. While systemic injustices impacting the traditionally underserved populations are rooted in irreversible history, there are a myriad of?practices that exist in today's healthcare system that continue to put Black individuals at a?disadvantage.?

The kidneys are two bean-shaped organs that are located just below the spine on each? side of the ribcage. They filter the blood to prevent waste products from accumulating, regulate? the body’s fluid balance, and assist in blood pressure regulation, red blood cell production, and? bone health.3 eGFR, or estimated glomerular filtration rate, is a formula that uses biochemical? values from a simple blood test to estimate kidney function. Measuring GFR is not widely?available due to the complexity and lengthiness of the process; it is for this reason that eGFR is? the primary method to determine kidney function and diagnose and stage CKD.4?

eGFR is calculated using serum creatinine levels, age, gender, and race, specifically as? “African American” or “not African American.” Creatinine is a waste product that comes from? the muscles and is normally filtered out by healthy kidneys; levels of creatinine are indicative of? kidney function.5 Age and gender are essential to account for age and sex-related changes to? creatinine levels. The inclusion of race as a component of a supposedly objective value is rooted? in the assumption that Black individuals have higher muscle mass.6

This race-based algorithm? has raised concern in recent years due to the implications and unintended consequences of these? overlooked, underlying assumptions that are deeply integrated in clinical practice.??

There are a multitude of issues associated with these race-based correction factors. While? the understanding that Black individuals have higher muscle mass than non-Black individuals is? rooted in scientific evidence and may, albeit questionably, hold valid when looking at population-wide data, this is?certainly an overgeneralization of both groups.7 By this school of thought, an African American? individual would always have more muscle mass than a non-African American individual of the? same gender and age. This is certainly not the case.?

Furthermore, this race-based protocol is problematic? because it is dichotomous, with options to choose “African American” or “Non-African American.”

The correction factor does not consider those who are mixed races, those who may be Black but not African American (ie. Black individuals from continents other than Africa), those who may be African American but not Black (ie. individuals from South Africa), those who may not have been given the option to self-select their race, and may not meet typical aesthetic expectations for their selected race.?

A eGFR of 60 ml/min/1.73 m2 or more is considered normal. An eGFR below 60 ml/min/1.73 m2 is indicative of CKD, and an eGFR of 15 ml/min/1.73 m2 or less is called kidney failure; at this point, most people will require dialysis or a kidney transplant to stay alive.??

Proposed Policy

There are multiple formulas used to calculate eGFR. Among these choices, the race based correction factor can be included or disregarded. This decision is typically made by those?who create, design, and calibrate the software and hardware of the technology required to get an ?eGFR value from a sample of blood. These decisions are higher up than individual practitioners in clinical practice.

There is no federal policy that mandates which equation to use or whether to?include or not include the race-based correction factor; these are individual decisions made by hospitals, companies, or organizations.

Different organizations have different recommendations and policies regarding which equation is best to use.8?

Bill S. 2649 (117th): BETTER Kidney Care Act aims to tackle many components of this systemic issue.9 The introduced bill works to ?support beneficiaries of Medicare and Medicaid services through a program that provides integrated care for individuals with End Stage Renal Disease (ESRD). Introduced to the Senate,?this federal policy does not specifically address a mandate to or not use race-based equations.?While the bill makes great progress in many areas and clearly addresses the health disparity, saying, "Compared to Whites, Black Americans are 2.6 times more likely to have kidney failure 9" there is no mentioning of these race-based equations.

When calculating eGFR for end-stage renal disease, the National Kidney Foundation?makes the claim that Black/African Americans can have, on average, higher levels of creatinine ?in their blood, despite the lack of evidence for implementing this school of thought.10 This disparity can have a myriad of consequences for Black or African American patients.

Therefore, race-based correction factors should not be routinely used in clinical practices?to predict renal function using eGFR in the absence of a comprehensive, patient-first evaluation.

The current race-based correction should be replaced with?an accurate, representative, unbiased alternative that offers a standardized approach to testing ?kidney disease.11 This alternative should address unique considerations of each patient. To effect this change, federal policy must require company policy adjustments or reevaluations by mandating nationwide standards against the use of these race-based coefficients. ?

This policy change would provide a solution as it advocates for the eradication or reconsideration of race-based calculations in eGFR formulas. With great potential for a public?health impact, this policy change will particularly benefit African American communities, as well as those who identify as multiracial. The natural dichotomy which exists in this practice of using race-based correction factors is, in fact, a large component of the problem. Coordinated and unbiased care is the ultimate goal of this proposed addition to bill.11

This will improve the quality of care, as well as the prevention and early treatment, delivered to individuals with ESRD. Earlier diagnosis and intervention will contribute to reduced Medicare and Medicaid healthcare costs and improve patient outcomes.

An earlier, equitable diagnosis, which is currently limited by these race-based coefficients, means earlier access to a Registered Dietitian Nutritionist and a multitude of other services for those covered by Medicare.

Medical nutrition therapy (MNT) is covered by Medicare for those with a diagnosis of diabetes, non-dialysis kidney disease (stages 3-5), and 36 months post kidney transplant. The Medical Nutrition Therapy Act expands coverage for Medicare beneficiaries. This act also promotes health equity and has been introduced in both the U.S. Senate by Senators Susan Collins (R-ME) and Gary Peters (D-MI) and in the U.S. House of Representatives by Congresswomen Robin Kelly (D-IL) and Jen Kiggans (R-VA). For more see https://www.eatrightpro.org/advocacy/initiatives/medical-nutrition-therapy-act

The goal of the policy update of Bill S. 2649 (117th): BETTER Kidney Care Act is to work towards achieving?health equity and reducing health disparities.

I urge you to participate in making this change by writing or calling your representative and senators in Congress about S. 2649 (117th). Please visit: https://www.govtrack.us/congress/bills/117/s2649/comment

Additional credit to Allison Leukanech, Berghan Dix, Chaltu Wejega, and Shakirah Lidge

Resources?

1. Chronic kidney disease in the United States, 2021. Centers for Disease Control and? Prevention. https://www.cdc.gov/kidneydisease/publications-resources/ckd-national facts.html. Published July 12, 2022. Accessed October 19, 2022.??

2. Race, ethnicity, & kidney disease. National Institute of Diabetes and Digestive and? Kidney Diseases. https://www.niddk.nih.gov/health-information/kidney-disease/race ethnicity. Accessed October 19, 2022.??

3. How your kidneys work. National Kidney Foundation.??

https://www.kidney.org/kidneydisease/howkidneyswrk. Published February 1, 2022.? Accessed October 19, 2022.??

4. Estimated glomerular filtration rate (egfr). National Kidney Foundation.? https://www.kidney.org/atoz/content/gfr. Published October 10, 2022. Accessed October? 19, 2022.??

5. Estimating glomerular filtration rate. National Institute of Diabetes and Digestive and? Kidney Diseases. https://www.niddk.nih.gov/health-information/professionals/clinical tools-patient-management/kidney-disease/laboratory-evaluation/glomerular-filtration rate/estimating. Accessed October 19, 2022.??

6. Braun L, Wentz A, Baker R, Richardson E, Tsai J. Racialized algorithms for kidney? function: Erasing social experience. Soc Sci Med. 2021;268:113548.??

doi:10.1016/j.socscimed.2020.113548?

7. Race and EGFR: What is the controversy? National Kidney Foundation.? https://www.kidney.org/atoz/content/race-and-egfr-what-controversy. Published? December 6, 2021. Accessed October 20, 2022. ?

8. Removing Race from Estimates of Kidney Function. National Kidney Foundation. ?https://www.kidney.org/news/removing-race-estimates-kidney-function. Published? March 9, 2021. Accessed October 21, 2022,?

9. "Committees - S.2649 - 117th Congress (2021-2022): BETTER Kidney Care Act." ?Congress.gov, Library of Congress, https://www.congress.gov/. Published August 5,? 2021 ?

10. KidneyCareMatters. (2020). Better Kidney Care Act: Dialysis patient citizens. ?KidneyCareMatters. Retrieved October 22, 2022, from??

https://www.kidneycarematters.org/better-kidney-care-act?

11. Estimated Glomerular Filtration Rate (eGFR) | Labcorp. www.labcorp.com.? https://www.labcorp.com/help/patient-test-info/estimated-glomerular-filtration-rate-egfr.? Accessed October 20, 2022?

12. Medicare Coverage of Kidney Dialysis & Kidney Transplant Services. Department ?of Health and Human Services. https://www.medicare.gov/publications/10128-medicare coverage-esrd.pdf. Accessed October 23, 2022