Overcoming barriers to implementing new guideline-directed therapies for chronic kidney disease.

For the first time in many years, guideline-directed drug therapies have emerged that offer substantial cardiorenal benefits, improved quality of life and longevity in patients with chronic kidney disease (CKD) and type 2 diabetes. These treatment options include sodium-glucose cotransporter-2 inhibitors, nonsteroidal mineralocorticoid receptor antagonists and glucagon-like peptide-1 receptor agonists. However, despite compelling evidence from multiple clinical trials, their uptake has been slow in routine clinical practice, reminiscent of the historical evolution of angiotensin-converting enzyme inhibitor and angiotensin II receptor blocker use. The delay in implementation of these evidence-based therapies highlights the many challenges to optimal CKD care, including: (i) clinical inertia; (ii) low CKD awareness; (iii) suboptimal kidney disease education among patients and providers; (iv) lack of patient and community engagement; (v) multimorbidity and polypharmacy; (vi) challenges in the primary care setting; (vii) fragmented CKD care; (viii) disparities in underserved populations; (ix) lack of public policy focused on health equity; and (x) high drug prices. These barriers to optimal cardiorenal outcomes can be ameliorated by a multifaceted approach, using the Chronic Care Model framework, to include patient and provider education, patient self-management programs, shared decision making, electronic clinical decision support tools, quality improvement initiatives, clear practice guidelines, multidisciplinary and collaborative care, provider accountability, and robust health information technology. It is incumbent on the global kidney community to take on a multidimensional perspective of CKD care by addressing patient-, community-, provider-, healthcare system- and policy-level barriers.

Racial and Socioeconomic Disparities in CKD in the Context of Universal Health Care Provided by the Military Health System.

RATIONALE & OBJECTIVE: Health-impeding social determinants of health-including reduced access to care-contribute to racial and socioeconomic disparities in chronic kidney disease (CKD). The Military Health System (MHS) provides an opportunity to assess a large, diverse population for CKD disparities in the context of universal health care. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: MHS beneficiaries aged 18 to 64 years receiving care between October 1, 2015, and September 30, 2018. PREDICTORS: Race, sponsor's rank (a proxy for socioeconomic status and social class), median household income by sponsor's zip code, and marital status. OUTCOME: CKD prevalence, defined by International Classification of Diseases, Tenth Revision codes and/or a validated, laboratory value-based electronic phenotype. ANALYTICAL APPROACH: Multivariable logistic regression compared CKD prevalence by predictors, controlling separately for confounders (age, sex, active-duty status, sponsor's service branch, and depression) and mediators (hypertension, diabetes, HIV, and body mass index). RESULTS: Of 3,330,893 beneficiaries, 105,504 (3.2%) had CKD. In confounder-adjusted models, the CKD prevalence was higher in Black versus White beneficiaries (OR, 1.67; 95% CI, 1.64-1.70), but lower in single versus married beneficiaries (OR, 0.77; 95% CI, 0.76-0.79). The prevalence of CKD was increased among those with a lower military rank and among those with a lower median household income in a nearly dose-response fashion (P < 0.0001). Associations were attenuated when further adjusting for suspected mediators. LIMITATIONS: The cross-sectional design prevents causal inferences. We may have underestimated the CKD prevalence, given a lack of data for laboratory tests conducted outside the MHS and the use of a specific CKD definition. The transient nature of the MHS population may limit the accuracy of zip code-level median household income data. CONCLUSIONS: Racial and socioeconomic CKD disparities exist in the MHS despite universal health care coverage. The existence of CKD disparities by rank and median household income suggests that social risks may contribute to both racial and socioeconomic disparities despite access to universal health care coverage.

CKD Prevalence in the Military Health System: Coded Versus Uncoded CKD.

RATIONALE & OBJECTIVE: Chronic kidney disease (CKD) is common but often goes unrecorded. STUDY DESIGN: Cross-sectional. SETTING & PARTICIPANTS: Military Health System (MHS) beneficiaries aged 18 to 64 years who received care during fiscal years 2016 to 2018. PREDICTORS: Age, sex, active duty status, race, diabetes, hypertension, and numbers of kidney test results. OUTCOMES: We defined CKD by International Classification of Diseases, Tenth Revision (ICD-10) code and/or a positive result on a validated electronic phenotype that uses estimated glomerular filtration rate and measures of proteinuria with evidence of chronicity. We defined coded CKD by the presence of an ICD-10 code. We defined uncoded CKD by a positive e-phenotype result without an ICD-10 code. ANALYTICAL APPROACH: We compared coded and uncoded populations using 2-tailed t tests (continuous variables) and Pearson χ2 test for independence (categorical variables). RESULTS: The MHS population included 3,330,893 beneficiaries. Prevalence of CKD was 3.2%, based on ICD code and/or positive e-phenotype result. Of those identified with CKD, 63% were uncoded. Compared with beneficiaries with coded CKD, those with uncoded CKD were younger (aged 45 ± 13 vs 52 ± 11 years), more often women (54.4% vs 37.6%) and active duty (20.2% vs 12.5%), and less often of Black race (18.5% vs 31.5%) or with diabetes (23.5% vs 43.5%) or hypertension (46.6% vs 77.1%; P < 0.001). Beneficiaries with coded (vs uncoded) CKD had greater numbers of kidney test results (P < 0.001). LIMITATIONS: Use of cross-sectional administrative data prevents inferences about causality. The CKD e-phenotype may fail to capture CKD in individuals without laboratory data and may underestimate CKD. CONCLUSIONS: The prevalence of CKD in the MHS is ~3.2%. Beneficiaries with well-known CKD risk factors, such as older age, male sex, Black race, diabetes, and hypertension, were more likely to be coded, suggesting that clinicians may be missing CKD in groups traditionally considered lower risk, potentially resulting in suboptimal care.

Development and Validation of a Pragmatic Electronic Phenotype for CKD.

BACKGROUND AND OBJECTIVES: Poor identification of individuals with CKD is a major barrier to research and appropriate clinical management of the disease. We aimed to develop and validate a pragmatic electronic (e-) phenotype to identify patients likely to have CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The e-phenotype was developed by an expert working group and implemented among adults receiving in- or outpatient care at five healthcare organizations. To determine urine albumin (UA) dipstick cutoffs for CKD to enable use in the e-phenotype when lacking urine albumin-to-creatinine ratio (UACR), we compared same day UACR and UA results at four sites. A sample of patients, spanning no CKD to ESKD, was randomly selected at four sites for validation via blinded chart review. RESULTS: The CKD e-phenotype was defined as most recent eGFR <60 ml/min per 1.73 m2 with at least one value <60 ml/min per 1.73 m2 >90 days prior and/or a UACR of ≥30 mg/g in the most recent test with at least one positive value >90 days prior. Dialysis and transplant were identified using diagnosis codes. In absence of UACR, a sensitive CKD definition would consider negative UA results as normal to mildly increased (KDIGO A1), trace to 1+ as moderately increased (KDIGO A2), and ≥2+ as severely increased (KDIGO A3). Sensitivity, specificity, and diagnostic accuracy of the CKD e-phenotype were 99%, 99%, and 98%, respectively. For dialysis sensitivity was 94% and specificity was 89%. For transplant, sensitivity was 97% and specificity was 91%. CONCLUSIONS: The CKD e-phenotype provides a pragmatic and accurate method for EHR-based identification of patients likely to have CKD.

Need for a Judicious Use of Nonsteroidal Anti-inflammatory Drugs to Avoid Community-Acquired Acute Kidney Injury.

Millions of Americans use over-the-counter analgesics on a daily basis, and nearly 100 million nonsteroidal anti-inflammatory drug (NSAID) prescriptions are filled per year. In high-risk patients, these medications can disrupt kidney hemodynamics and precipitate community-acquired acute kidney injury (CA-AKI). The risk of NSAID-associated CA-AKI increases 3- to 5-fold in patients taking renin-angiotensin system inhibitors and diuretics concurrently. CA-AKI increases the risk of developing chronic kidney disease (CKD) or accelerating progression of pre-existing CKD. Importantly, many cases of NSAID-induced CA-AKI may be avoided by identifying high-risk patients and providing patient and provider education on when to avoid these medications and minimize risk.

Managing CKD by Telemedicine: The Zuni Telenephrology Clinic.

Telemedicine has significant potential to extend nephrology consultation to rural and isolated communities. We describe a telenephrology clinic that has delivered ongoing consultative care from a nephrologist based at the National Institutes of Health in Bethesda, MD, to the Zuni Comprehensive Health Center in western New Mexico. Over the past 9 years, the clinic has conducted 1870 patient visits managing patients using a collaborative approach engaging a nurse case manager, nephrologist, primary clinicians, pharmacists, and community health nurses. A significant proportion of the care provided is directed toward patients with advanced kidney disease (estimated glomerular filtration rate <30 mL/min/1.73 m2). Although there are unique aspects to the Indian Health Service and to the Zuni community which is served by this clinic, this telemedicine clinic does serve as a demonstration that nephrologic consultative care can be delivered effectively and efficiently to rural high-risk communities using a collaborative and integrated model of care.

CE: Improving Outcomes for Patients with Chronic Kidney Disease: Part 2.

: Coping with chronic kidney disease (CKD) is challenging for many people, since symptoms often don't appear until the disease is advanced and the patient is close to requiring dialysis. This two-part article aims to provide nurses with the basic information necessary to assess and manage patients with CKD. Part 1, which appeared last month, offered an overview of the disease, described identification and etiology, and discussed ways to slow disease progression. Part 2 addresses disease complications and treatment for kidney failure.

Vital Signs: Decrease in Incidence of Diabetes-Related End-Stage Renal Disease among American Indians/Alaska Natives - United States, 1996-2013.

BACKGROUND: American Indians and Alaska Natives (AI/AN) have the highest diabetes prevalence among any racial/ethnic group in the United States. Among AI/AN, diabetes accounts for 69% of new cases of end-stage renal disease (ESRD), defined as kidney failure treated with dialysis or transplantation. During 1982-1996, diabetes-related ESRD (ESRD-D) in AI/AN increased substantially and disproportionately compared with other racial/ethnic groups. METHODS: Data from the U.S. Renal Data System, the Indian Health Service (IHS), the National Health Interview Survey, and the U.S. Census were used to calculate ESRD-D incidence rates by race/ethnicity among U.S. adults aged ≥18 years during 1996-2013 and in the diabetic population during 2006-2013. Rates were age-adjusted based on the 2000 U.S. standard population. IHS clinical data from the Diabetes Cares and Outcomes Audit were analyzed for diabetes management measures in AI/AN. RESULTS: Among AI/AN adults, age-adjusted ESRD-D rates per 100,000 population decreased 54%, from 57.3 in 1996 to 26.5 in 2013. Although rates for adults in other racial/ethnic groups also decreased during this period, AI/AN had the steepest decline. Among AI/AN with diabetes, ESRD-D incidence decreased during 2006-2013 and, by 2013, was the same as that for whites. Measures related to the assessment and treatment of ESRD-D risk factors also showed more improvement during this period in AI/AN than in the general population. CONCLUSION AND IMPLICATIONS FOR PUBLIC HEALTH PRACTICE: Despite well-documented health and socioeconomic disparities among AI/AN, ESRD-D incidence rates among this population have decreased substantially since 1996. This decline followed implementation by the IHS of public health and population management approaches to diabetes accompanied by improvements in clinical care beginning in the mid-1980s. These approaches might be a useful model for diabetes management in other health care systems, especially those serving populations at high risk.

CE: Improving Outcomes for Patients with Chronic Kidney Disease: Part 1.

: The burden of chronic kidney disease (CKD) is rising both in this country and worldwide. An estimated 10% to 15% of U.S. adults are currently living with CKD. Reducing the CKD burden requires a systematic, interdisciplinary approach to care. The greatest opportunities to reduce the impact of CKD arise early, when most patients are being followed in primary care; yet many clinicians are inadequately educated on this disease. Nurses are well positioned to facilitate the implementation of collaborative care. This two-part article aims to provide nurses with the basic information necessary to assess and manage patients with CKD. Part 1 offers an overview of the disease, describes identification and etiology, and discusses ways to slow disease progression. Part 2, which will appear next month, addresses disease complications and treatment of kidney failure.

Standardization of Urine Albumin Measurements: Status and Performance Goals.

BACKGROUND: Urine albumin is a key laboratory test used for classification, assessment of risk, and monitoring treatment of patients with chronic kidney disease. Urine albumin measurement results are not standardized among different measurement procedures. Consequently, clinical guidelines using fixed decision values for urine albumin cannot be applied consistently. CONTENT: Isotope dilution mass spectrometry reference measurement procedures and certified reference materials are being developed to enable standardization of immunoassay measurement procedures for urine albumin. A previous report determined calibration bias was the major error source for differences in results among different measurement procedures for urine albumin. Performance goals for between-day precision, ≤6% CV above 15 mg/L, and for specimen-specific effects, ≤6% CV, were established on the basis of the performance capability of current measurement procedures. The biological variation model was used to estimate a total allowable error of ≤24%-30% and from that the goal for bias of ≤7%-13%. SUMMARY: A reference system of higher-order certified reference materials and reference measurement procedures is being developed to enable standardization of urine albumin measurement results. Goals have been established for total allowable error, specimen-specific effects, imprecision, and bias to facilitate efforts to standardize urine albumin measurement results.

Personalizing Longitudinal Care Coordination for Patients with Chronic Kidney Disease.

Chronic care coordination efforts often focus on the needs of the healthcare team and not on the individual needs of each patient. However, developing a personalized care plan for patients with Chronic Kidney Disease (CKD) requires individual patient engagement with the health care team. We describe the development of a CKD e-care plan that focuses on patient specific needs and life goals, and can be personalized according to provider needs.

Social Determinants of Racial Disparities in CKD.

Significant disparities in CKD rates and outcomes exist between black and white Americans. Health disparities are defined as health differences that adversely affect disadvantaged populations, on the basis of one or more health outcomes. CKD is the complex result of genetic and environmental factors, reflecting the balance of nature and nurture. Social determinants of health have an important role as environmental components, especially for black populations, who are disproportionately disadvantaged. Understanding the social determinants of health and appreciating the underlying differences associated with meaningful clinical outcomes may help nephrologists treat all their patients with CKD in an optimal manner. Altering the social determinants of health, although difficult, may embody important policy and research efforts, with the ultimate goal of improving outcomes for patients with kidney diseases, and minimizing the disparities between groups.

Educating Patients about CKD: The Path to Self-Management and Patient-Centered Care.

Patient education is associated with better patient outcomes and supported by international guidelines and organizations, but a range of barriers prevent widespread implementation of comprehensive education for people with progressive kidney disease, especially in the United States. Among United States patients, obstacles to education include the complex nature of kidney disease information, low baseline awareness, limited health literacy and numeracy, limited availability of CKD information, and lack of readiness to learn. For providers, lack of time and clinical confidence combine with competing education priorities and confusion about diagnosing CKD to limit educational efforts. At the system level, lack of provider incentives, limited availability of practical decision support tools, and lack of established interdisciplinary care models inhibit patient education. Despite these barriers, innovative education approaches for people with CKD exist, including self-management support, shared decision making, use of digital media, and engaging families and communities. Education efficiency may be increased by focusing on people with progressive disease, establishing interdisciplinary care management including community health workers, and providing education in group settings. New educational approaches are being developed through research and quality improvement efforts, but challenges to evaluating public awareness and patient education programs inhibit identification of successful strategies for broader implementation. However, growing interest in improving patient-centered outcomes may provide new approaches to effective education of people with CKD.

Association of Erythropoietin Dose and Route of Administration with Clinical Outcomes for Patients on Hemodialysis in the United States.

BACKGROUND AND OBJECTIVES: Recombinant human erythropoietin (epoetin) is used routinely to increase blood hemoglobin levels in patients with ESRD and anemia. Although lower doses of epoetin are required to achieve equivalent hemoglobin responses when administered subcutaneously rather than intravenously, standard practice has been to administer epoetin to patients on hemodialysis intravenously. Randomized trials of alternative epoetin treatment regimens in patients with kidney failure have shown that risks of cardiovascular complications and death are related to the dose levels of epoetin used. Therefore, given the dose-sparing advantages of subcutaneous epoetin administration, the possibility that treatment of patients on hemodialysis with subcutaneous epoetin might be associated with more favorable outcomes compared with intravenous treatment was investigated. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A retrospective cohort study of 62,710 adult patients on hemodialysis treated with either intravenous or subcutaneous epoetin-α and enrolled in the Centers for Medicare and Medicaid Services ESRD Clinical Performance Measures Project from 1997 to 2005 was carried out. Risks of death and/or hospitalization for cardiovascular complications (adverse composite event outcomes) during 2 years of follow-up were determined in relationship to epoetin dose and route of administration (intravenous versus subcutaneous) by multivariate Cox proportional hazard modeling adjusted for demographics and clinical parameters. RESULTS: Epoetin doses used to achieve equivalent hemoglobin responses in study patients were, on average, 25% higher when epoetin was administered intravenously rather than subcutaneously (as expected). Moreover, adverse composite event outcomes were found to be significantly more likely to occur during follow-up for patients on hemodialysis managed with intravenous rather than subcutaneous epoetin (adjusted hazard ratio for adverse events within 1 year [intravenous versus subcutaneous] was 1.11 [95% confidence interval, 1.04 to 1.18]). CONCLUSIONS: This study finds that treatment of patients on hemodialysis with subcutaneous epoetin is associated with more favorable clinical outcomes than those associated with intravenous epoetin treatment.

Laboratory Assessment of Diabetic Kidney Disease.

IN BRIEF Regardless of etiology, chronic kidney disease (CKD) is identified by two laboratory tests: 1) estimated glomerular filtration rate (eGFR), a measure of kidney function, and 2) urine albumin-to-creatinine ratio (UACR), a measure of kidney damage. It is crucial for all health professionals to understand the significance and limitations of these tests to appropriately identify CKD patients, guide therapy, and determine prognosis. This article provides information that will enable diabetes educators and other clinicians to properly interpret eGFR and UACR laboratory results in the identification and management of CKD.

Early chronic kidney disease: diagnosis, management and models of care.

Chronic kidney disease (CKD) is prevalent in many countries, and the costs associated with the care of patients with end-stage renal disease (ESRD) are estimated to exceed US$1 trillion globally. The clinical and economic rationale for the design of timely and appropriate health system responses to limit the progression of CKD to ESRD is clear. Clinical care might improve if early-stage CKD with risk of progression to ESRD is differentiated from early-stage CKD that is unlikely to advance. The diagnostic tests that are currently used for CKD exhibit key limitations; therefore, additional research is required to increase awareness of the risk factors for CKD progression. Systems modelling can be used to evaluate the impact of different care models on CKD outcomes and costs. The US Indian Health Service has demonstrated that an integrated, system-wide approach can produce notable benefits on cardiovascular and renal health outcomes. Economic and clinical improvements might, therefore, be possible if CKD is reconceptualized as a part of primary care. This Review discusses which early CKD interventions are appropriate, the optimum time to provide clinical care, and the most suitable model of care to adopt.