Equity and Quality of Global Chronic Kidney Disease Care: What Are We Waiting for?

BACKGROUND: Chronic kidney disease (CKD) is an important but insufficiently recognized public health problem. Unprecedented advances in delaying progression of CKD and reducing kidney failure and death have been made in recent years, with the addition of the sodium-glucose cotransporter 2 inhibitors and other newer medication to the established standard of care with inhibitors of the renin-angiotensin system. Despite knowledge of these effective therapies, their prescription and use remain suboptimal globally, and more specially in low resource settings. Many challenges contribute to this gap between knowledge and translation into clinical care, which is even wider in lower resource settings across the globe. Implementation of guideline-directed care is hampered by lack of disease awareness, late or missed diagnosis, clinical inertia, poor quality care, cost of therapy, systemic biases, and lack of patient empowerment. All of these are exacerbated by the social determinants of health and global inequities. SUMMARY: CKD is a highly manageable condition but requires equitable and sustainable access to quality care supported by health policies, health financing, patient and health care worker education, and affordability of medications and diagnostics. KEY MESSAGES: The gap between the knowledge and tools to treat CKD and the implementation of optimal quality kidney care should no longer be tolerated. Advocacy, research and action are required to improve equitable access to sustainable quality care for CKD everywhere.

Novel Prediction Equations for Absolute Risk Assessment of Total Cardiovascular Disease Incorporating Cardiovascular-Kidney-Metabolic Health: A Scientific Statement From the American Heart Association.

Cardiovascular-kidney-metabolic (CKM) syndrome is a novel construct recently defined by the American Heart Association in response to the high prevalence of metabolic and kidney disease. Epidemiological data demonstrate higher absolute risk of both atherosclerotic cardiovascular disease (CVD) and heart failure as an individual progresses from CKM stage 0 to stage 3, but optimal strategies for risk assessment need to be refined. Absolute risk assessment with the goal to match type and intensity of interventions with predicted risk and expected treatment benefit remains the cornerstone of primary prevention. Given the growing number of therapies in our armamentarium that simultaneously address all 3 CKM axes, novel risk prediction equations are needed that incorporate predictors and outcomes relevant to the CKM context. This should also include social determinants of health, which are key upstream drivers of CVD, to more equitably estimate and address risk. This scientific statement summarizes the background, rationale, and clinical implications for the newly developed sex-specific, race-free risk equations: PREVENT (AHA Predicting Risk of CVD Events). The PREVENT equations enable 10- and 30-year risk estimates for total CVD (composite of atherosclerotic CVD and heart failure), include estimated glomerular filtration rate as a predictor, and adjust for competing risk of non-CVD death among adults 30 to 79 years of age. Additional models accommodate enhanced predictive utility with the addition of CKM factors when clinically indicated for measurement (urine albumin-to-creatinine ratio and hemoglobin A1c) or social determinants of health (social deprivation index) when available. Approaches to implement risk-based prevention using PREVENT across various settings are discussed.

Construct validity, ecological validity and acceptance of self-administered online neuropsychological assessment in adults.

Objective: The goal of this project was to explore the initial psychometric properties (construct and ecological validity) of self-administered online (SAO) neuropsychological assessment (using the www.testmybrain.org platform), compared to traditional testing, in a clinical sample, as well as to evaluate participant acceptance. SAO assessment has the potential to expand the reach of in-person neuropsychological assessment approaches.Method: Counterbalanced, within-subjects design comparing SAO performance to in-person performance in adults with diabetes with and without Chronic Kidney Disease (CKD). Forty-nine participants completed both assessment modalities (type 1 diabetes N = 14, type 2 diabetes N = 35; CKD N = 18).Results: Associations between SAO and analogous in-person tests were adequate to good (r = 0.49-0.66). Association strength between divergent cognitive tests did not differ between SAO versus in-person tests. SAO testing was more strongly associated with age than in-person testing (age R2=0.54 versus 0.23), while prediction of education, HbA1c, and estimated glomerular filtration rate (eGFR) did not differ significantly between test modalities (education R2=0.37 versus 0.30; HbA1c R2=0.20 versus 0.12; eGFR R2 = 0.41 versus 0.33). Associations with measures of everyday functioning were also similar (Functional Activities Questionnaire R2=0.08 versus 0.07; Neuro-QoL R2=0.14 versus 0.16; Diabetes Self-Management Questionnaire R2=0.19 versus 0.19).Conclusions: The selected SAO neuropsychological tests had acceptable construct validity (including divergent, convergent, and criterion-related validity), and similar ecological validity to that of traditional testing. These SAO assessments were acceptable to participants and appear appropriate for use in research applications, although further research is needed to better understand the strengths and weaknesses in other clinical populations.

Integrating Patient Priorities with Science by Community Engagement in the Kidney Precision Medicine Project.

The Kidney Precision Medicine Project (KPMP) is a multisite study designed to improve understanding of CKD attributed to diabetes or hypertension and AKI by performing protocol-driven kidney biopsies. Study participants and their kidney tissue samples undergo state-of-the-art deep phenotyping using advanced molecular, imaging, and data analytical methods. Few patients participate in research design or concepts for discovery science. A major goal of the KPMP is to include patients as equal partners to inform the research for clinically relevant benefit. The purpose of this report is to describe patient and community engagement and the value they bring to the KPMP. Patients with CKD and AKI and clinicians from the study sites are members of the Community Engagement Committee, with representation on other KPMP committees. They participate in KPMP deliberations to address scientific, clinical, logistic, analytic, ethical, and community engagement issues. The Community Engagement Committee guides KPMP research priorities from perspectives of patients and clinicians. Patients led development of essential study components, including the informed consent process, no-fault harm insurance coverage, the ethics statement, return of results plan, a "Patient Primer" for scientists and the public, and Community Advisory Boards. As members across other KPMP committees, the Community Engagement Committee assures that the science is developed and conducted in a manner relevant to study participants and the clinical community. Patients have guided the KPMP to produce research aligned with their priorities. The Community Engagement Committee partnership has set new benchmarks for patient leadership in precision medicine research.

Capturing anaphylaxis through medical records: Are ICD and CPT codes sufficient?

OBJECTIVE: The identification of anaphylaxis cases is imperative for optimal clinicalprovider knowledge deficiencies in diagnosis and treatment and the efficacy of reimbursement codes, such as International Classification of Diseases (ICD) and current procedural terminology (CPT) codes, in detecting anaphylaxis. DATA SOURCES: Pubmed. STUDY SELECTIONS: Recent and clinically relevant literature on anaphylaxis and provider knowledge, ICD, CPT, Healthcare Common Procedural Coding System (HCPCS), and E-codes were selected and reviewed. RESULTS: Reimbursement codes are used to detect anaphylaxis in administrative claims databases. Inaccurate recognition of the diagnosis by providers, underreporting, and cause identification are challenges faced by health researchers using reimbursement codes for anaphylaxis case identification. Anaphylactic shock-specific ICD codes were noted to have a positive predictive value (PPV) of 52% to 53% of anaphylaxis events compared with physician chart review, which was improved to 63% to 67.3% when used in conjunction with anaphylaxis symptom-specific ICD, CPT, HCPCS, and E-codes 31, 34, and 35. CONCLUSION: Education of providers to properly diagnose and treat anaphylaxis requires systematic and educational investments. The ICD codes specific to anaphylactic shock have suboptimal PPV to identify anaphylaxis in administrative claims databases. Use of algorithms incorporating other reimbursement codes improve the PPV, but they are limited by inaccurate diagnoses and underreporting of anaphylaxis. Future ICD-11 reclassification may improve anaphylaxis detection by reimbursement codes.

Development of an International Standard Set of Value-Based Outcome Measures for Patients With Chronic Kidney Disease: A Report of the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group.

Value-based health care is increasingly promoted as a strategy for improving care quality by benchmarking outcomes that matter to patients relative to the cost of obtaining those outcomes. To support the shift toward value-based health care in chronic kidney disease (CKD), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international working group of health professionals and patient representatives to develop a standardized minimum set of patient-centered outcomes targeted for clinical use. The considered outcomes and patient-reported outcome measures were generated from systematic literature reviews. Feedback was sought from patients and health professionals. Patients with very high-risk CKD (stages G3a/A3 and G3b/A2-G5, including dialysis, kidney transplantation, and conservative care) were selected as the target population. Using an online modified Delphi process, outcomes important to all patients were selected, such as survival and hospitalization, and to treatment-specific subgroups, such as vascular access survival and kidney allograft survival. Patient-reported outcome measures were included to capture domains of health-related quality of life, which were rated as the most important outcomes by patients. Demographic and clinical variables were identified to be used as case-mix adjusters. Use of these consensus recommendations could enable institutions to monitor, compare, and improve the quality of their CKD care.

Medication Therapy Management after Hospitalization in CKD: A Randomized Clinical Trial.

BACKGROUND AND OBJECTIVES: CKD is characterized by remarkably high hospitalization and readmission rates. Our study aim was to test a medication therapy management intervention to reduce subsequent acute care utilization. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The CKD Medication Intervention Trial was a single-blind (investigators), randomized clinical trial conducted at Providence Health Care in Spokane, Washington. Patients with CKD stages 3-5 not treated by dialysis who were hospitalized for acute illness were recruited. The intervention was designed to improve posthospitalization care by medication therapy management. A pharmacist delivered the intervention as a single home visit within 7 days of discharge. The intervention included these fundamental elements: comprehensive medication review, medication action plan, and a personal medication list. The primary outcome was a composite of acute care utilization (hospital readmissions and emergency department and urgent care visits) for 90 days after hospitalization. RESULTS: Baseline characteristics of participants (n=141) included the following: age, 69±11 (mean±SD) years old; women, 48% (67 of 141); diabetes, 56% (79 of 141); hypertension, 83% (117 of 141); eGFR, 41±14 ml/min per 1.73 m2 (serum creatinine-based Chronic Kidney Disease Epidemiology Collaboration equation); and urine albumin-to-creatinine ratio median, 43 mg/g (interquartile range, 8-528) creatinine. The most common primary diagnoses for hospitalization were the following: cardiovascular events, 36% (51 of 141); infections, 18% (26 of 141); and kidney diseases, 12% (17 of 141). The primary outcome occurred in 32 of 72 (44%) of the medication intervention group and 28 of 69 (41%) of those in usual care (log rank P=0.72). For only hospital readmission, the rate was 19 of 72 (26%) in the medication intervention group and 18 of 69 (26%) in the usual care group (log rank P=0.95). There was no between-group difference in achievement of guideline-based goals for use of renin-angiotensin system inhibition or for BP, hemoglobin, phosphorus, or parathyroid hormone. CONCLUSIONS: Acute care utilization after hospitalization was not reduced by a pharmacist-led medication therapy management intervention at the transition from hospital to home.

Connecting Patients to Prescription Assistance Programs: Effects on Emergency Department and Hospital Utilization.

BACKGROUND: Manufacturer prescription assistance programs (PAPs) have been developed to provide medications at little or no cost to eligible patients. There are over 200 PAPs available from pharmaceutical companies, and each may have different eligibility requirements and assistance guidelines. A formalized community-based patient prescription coordinator can help patients navigate these programs by reviewing an applicant's financial information and medication requirements to identify which PAPs are most appropriate. Little is known, however, about whether providing such guidance is associated with a reduction in acute care utilization. OBJECTIVE: To evaluate changes in emergency department and hospital utilization among patients who received care coordination and financial assistance with prescribed medications. METHODS: This single-cohort interrupted time-series study included participants in eastern Washington state who enrolled in the Spokane Prescription Assistance Network (SPAN) program between March 1, 2009, and August 31, 2012. Referrals to the SPAN patient prescription coordinator were made by a social service agency or medical provider for patients who may have difficulty paying for prescribed medications. Initial patient contact occurred while the patient was still being treated in a clinic or hospital or through a direct visit to the coordinator's community-based office. Participants were contacted 6 months after the initial appointment and then annually thereafter to review current medications and health status. A review of electronic health records provided information on hospitalizations and emergency department visits in the 12 months before and after program entry. RESULTS: Among SPAN participants (n = 310), emergency department and hospital encounters declined from 0.38 per participant in the year before enrollment to 0.20 encounters in the year following program entry. A repeated-measures mixed-effects model indicated SPAN participation was associated with a 51% decline in the rate of emergency department and hospital utilization (incidence rate ratio [IRR] = 0.49; 95% CI = 0.31-0.77; P = 0.002). Observed effects differed by prescription class. Factor interactions revealed significant reductions in utilization for participants with prescribed pulmonary medications (IRR = 0.58; 95% CI = 0.37-0.92; P = 0.019). Assistance with mental health (psychotropic) medications was associated with increased incidence of utilization (IRR = 2.07; 95% CI = 1.32-3.24; P = 0.001). At the time of SPAN enrollment, 60% of participants had prescriptions for psychotropic medications. CONCLUSIONS: A formalized patient prescription coordinator can help patients access prescribed medications at low cost and remain compliant with treatment plans. In a study of a coordination pilot program, reductions in hospital admissions and emergency department visits were observed following program participation. DISCLOSURES: This study was not supported by any outside funding. The authors declare no conflicts of interest. Study design was created by Burley, McPherson, and Daratha. Burley Daratha, Selinger, and Armstrong collected the data, with interpretation performed by Burley, Daratha, and Tuttle, assisted by McPherson. The manuscript was written by Burley, Daratha, and Selinger, with assistance from White, and revised by Burley, White, and Selinger, with assistance from Daratha and Tuttle.

Proteinuria as a surrogate outcome in CKD: report of a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration.

Changes in proteinuria have been suggested as a surrogate outcome for kidney disease progression to facilitate the conduct of clinical trials. This report summarizes a workshop sponsored by the National Kidney Foundation and US Food and Drug Administration (FDA) with the following goals: (1) to evaluate the strengths and limitations of criteria for assessment of proteinuria as a potential surrogate end point for clinical trials in chronic kidney disease (CKD), (2) to explore the strengths and limitations of available data for proteinuria as a potential surrogate end point, and (3) to delineate what more needs to be done to evaluate proteinuria as a potential surrogate end point. We review the importance of proteinuria in CKD, including the conceptual model for CKD, measurement of proteinuria and albuminuria, and epidemiological characteristics of albuminuria in the United States. We discuss surrogate end points in clinical trials of drug therapy, including criteria for drug approval, the definition of a surrogate end point, and criteria for evaluation of surrogacy based on biological plausibility, epidemiological characteristics, and clinical trials. Next, the report summarizes data for proteinuria as a potential surrogate outcome in 3 broad clinical areas: early diabetic kidney disease, nephrotic syndrome, and diseases with mild to moderate proteinuria. We conclude with a synthesis of data and recommendations for further research. At the present time, there appears to be sufficient evidence to recommend changes in proteinuria as a surrogate for kidney disease progression in only selected circumstances. Further research is needed to define additional contexts in which changes in proteinuria can be expected to predict treatment effect. We recommend collaboration among many groups, including academia, industry, the FDA, and the National Institutes of Health, to share data from past and future studies.