Integration of Chronic Kidney Disease Prevention into the Uruguayan National Program for Noncommunicable Diseases

Chapter 33

Integration of Chronic Kidney Disease Prevention into the Uruguayan National Program for Noncommunicable Diseases Laura Sola University of the Republic, Montevideo, Uruguay

Chapter Outline 1 Introduction 2 The Uruguayan context 3 Noncommunicable diseases in Uruguay 4 Surveillance of noncommunicable diseases 5 Risk factors for noncommunicable diseases 6 Programs for prevention of noncommunicable diseases 7 Prevalence and treatment of CKD; end-stage renal disease 7.1 National Registry of glomerulopathies 8 National Renal Healthcare Program

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8.1 Goals of the National Renal Healthcare Program 8.2 Methodology for developing and spreading the NRHP 9 Inclusion of CKD screening in the mandatory health check-up 10 Evaluation of the CKD Program; The CKD Registry 11 Universalization of the CKD Program and regional expansion 12 Conclusions References

349 349 351 351 352 353 353

1 INTRODUCTION The Global Health Observatory is the World Health Organization’s portal with open access to data for monitoring the status of global health. Its data shows that countries with a higher life expectancy (developed countries) generally have lower maternal and neonatal mortality rates, lower mortality from infectious causes and a higher probability of death from cardiovascular diseases (CVD), cancer, diabetes, and chronic kidney disease (CKD) than developing countries [1]. Noncommunicable diseases (NCDs) are the leading cause of morbidity and mortality in developed countries and in the most developing countries [2]. The Global Burden of Diseases, Injuries, and Risk Factors Study—an initiative of the Institute for Health Metrics and Evaluation—is an effort to measure the epidemiology of burden of disease and trends worldwide, providing a tool which governments can use to improve their health systems and eliminate—or at least reduce—health-related disparities [3]. The Global Burden of Diseases Study has shown that NCDs are the driving force behind morbidity in most countries, including low- and middle-income countries. It has also shown that CKD was the 36th cause of death in 1990, and that it climbed up to the 19th position in 2013 [4]. Considering the Years of Life Lost to premature death, CKD is one of the top 10 causes of death in many Latin American countries. Most data regarding the burden of CKD was obtained from the United States Renal Data System end-stage renal disease (ESRD) registry over the past decade [5]. Based on this source, hypertension and diabetes are the leading causes of CKD in developed countries. For instance, nearly 40% of patients with Type 2 diabetes mellitus show signs of CKD and diabetes Chronic Kidney Disease in Disadvantaged Populations. http://dx.doi.org/10.1016/B978-0-12-804311-0.00033-9 Copyright © 2017 Elsevier Inc. All rights reserved.

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is the leading cause of CKD in the United States [6]. Accordingly with the high prevalence of CKD in this population, diabetes was the cause of ESRD in 44.2% of incident dialysis patients in 2011 [7]. In low- and middle-income countries, a double burden of communicable and NCDs is taking place. Apart from the increasing prevalence of hypertension and diabetes, regional nephropathies are also major causes of CKD, including secondary glomerulonephritis due to infectious diseases, Mesoamerican and Balkan nephropathies, among others [8]. In 2004, the ISN-COMGAN Bellagio Study Group warned policymakers and scientific societies about the global burden of CKD and the need for early diagnosis and prevention programs [9]. The group concluded that the most cost-effective strategies for developing countries are prevention, early detection and intervention, with a view to delaying the progression of CKD and CVD and thus decreasing the morbidity and mortality rates in these countries. Many patients continue to be referred to a nephrologist on a late stage—close to the time of initiating renal replacement therapy (RRT) [10,11]. This late referral prevents the possibility of delaying CKD progression [12] and has been associated with poorer results and increased healthcare costs once dialysis begins [13,14]. There is evidence that a longer duration of predialysis nephrological care is associated with improved health-care quality indicators at dialysis initiation, long-term survival of patients and enhanced quality of life once on dialysis [15,16]. A recent cochrane systematic review has shown that early referral is associated with a better preparation for and placement of dialysis access prior to dialysis and that it also improves patient morbidity and mortality on hemodialysis [17–19]. To enhance such predialysis care, several programs and strategies have been launched, depending on each country’s healthcare system and living standards [20–24].

2  THE URUGUAYAN CONTEXT Uruguay is a developing country with a population of 3,286,314 [25]. Over the past several decades, there has been a sustained increase in the ageing of the population; for example, the population aged 65 and above increase from 7.6% in 1963 to 14.1% in 2011. The percentage of elderly people is not distributed equally in all areas of the country, as some areas have a lower percentage (11% in Artigas, in the North) and others a higher percentage (e.g., 16.7% in Lavalleja). Life expectancy at birth has increased to 77 years (73 for males and 81 for females).

3  NONCOMMUNICABLE DISEASES IN URUGUAY As expected, following the demographic transition, an epidemiologic transition took place in Uruguay in the second-half of the 20th century. Since 1990, the burden of NCDs has been quite significant; 7 of the top 10 causes in Years of Life Lost to premature death were NCDs through 2013 [26]. No comprehensive programs for the prevention of NCDs exist in Uruguay at present; but there is one underway within the Department of Health’s NCDs Division. Currently there is a series of individual actions or plans being formulated, including antitobacco measures and early detection of diabetes, and some types of cancer (breast, cervix, and colon cancer). Presently, NCDs are being included among the priorities of the National Health Goals for 2020.

4  SURVEILLANCE OF NONCOMMUNICABLE DISEASES Surveillance of NCDs is coordinated by the Department of Health’s Epidemiology Division. It covers the three main areas of surveillance: mortality, morbidity, and risk factors. Mortality rates are estimated by the Vital Statistics Unit, based on birth certificates (live births) and death certificates. At present, both types of certificates are electronic, comprising almost 100% of births and deaths [27]. There is a National Registry for Cancer which provides additional information on the incidence and prevalence of cancer, with additional information on cancer mortality [28].

5  RISK FACTORS FOR NONCOMMUNICABLE DISEASES NCDs share common behavioral risk factors with other types of diseases. For example, tobacco smoking is the main risk factor leading to several neoplasms, CVD and to chronic respiratory diseases [29]. In 2006 and 2013, national surveys on NCD risk factors have been conducted in Uruguay, following the WHO STEPS [30] approach. These surveys have shown that population between the ages of 25 and 64 had a significant increase in overweight and obesity—from 56% to 64%, in high blood pressure (≥140/90 mmHg)—from 30% to 37%, and a significant reduction in tobacco smoking—from 32% to 28% [31,32]. The latter is probably a consequence of public health policies focusing on tobacco smoking reduction, which restricted tobacco advertising and forbade smoking in all closed public areas since 2006.

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6  PROGRAMS FOR PREVENTION OF NONCOMMUNICABLE DISEASES Regarding CVD, there are only a few prevention programs underway. There is one secondary prevention program for patients with coronary disease aged 70 or below who have had a coronary bypass or a percutaneous transluminal coronary angioplasty [33]. This program includes the administration of statins, inhibitors of platelets aggregation and hypertensive drugs; this program has been associated with a reduction in new procedures and mortality rates among the intervention group [34].

7  PREVALENCE AND TREATMENT OF CKD; END-STAGE RENAL DISEASE A national program for RRT aimed at patients with ESRD has been running in Uruguay since 1981, with the financial support of the National Resources Fund (FNR, for its acronym in Spanish). The Dialysis and Renal Transplant Registries have been collecting data on patients on RRT since the beginning [35]. Care of RRT patients is similar to the one observed in developed countries. Prevalence of ESRD patients on dialysis was 756 patients per million populations by December 2014, reaching almost 1000 per million populations when considering transplant patients with a functioning kidney graft are included [36]. Data obtained from the Uruguayan Dialysis Registry indicates that predialysis CKD care has been suboptimal [37]. Starting dialysis with a central venous catheter is a well-known risk factor for adverse events in dialysis patients, including infection, hospitalization and death. In Uruguay, only 20% of patients had a mature vascular access at dialysis initiation in 2004; this proportion has increased to 30% in 2014. Referral to nephrologists in the year prior to dialysis has significantly increased over the past 10 years, from 62% to 70% [38]. The overall prevalence of CKD is unknown, but it is estimated at 7.2% of the population based on CKD frequency in NHANES III and adjusted to the prevalence of dialysis patients in Uruguay.

7.1  National Registry of glomerulopathies A registry of renal biopsies has been kept voluntarily since 1981, partially financed by the FNR. It has been included in the Program for Prevention and Treatment of Glomerular Disease, whose members hold regular meetings at the Nephrology Center of the Uruguayan State University (Universidad de la República) Medical School [39,40]. Since 2000, per decree by the Department of Health, it became mandatory to enter all biopsies performed into that registry. The program also provides guidelines for managing glomerular disease [41].

8  NATIONAL RENAL HEALTHCARE PROGRAM In April 2004, representatives from the Uruguayan and Latin-American Societies of Nephrology, the Uruguayan Department of Health, the FNR and the WHO Pan-American Health Organization (PAHO) took part in a workshop at the Department of Health, in Montevideo. The “Declaration of Montevideo” was signed there, setting forth that it was necessary to enhance CKD care through early diagnosis and a comprehensive follow-up of CKD patients, with a view to preventing progression into ESRD and increasing planned dialysis initiation. For this to become effective, an Advisory Committee on Renal Healthcare (ACRH) had to be constituted and patients identified with CKD entered into a registry. Following this workshop, there have been talks with the FNR and the Department of Health to develop a National Renal Healthcare Program (NRHP), designed by the Uruguayan Society of Nephrology (SUN, for its acronym in Spanish) and the Nephrology Center of the Uruguayan State University Medical School.

8.1  Goals of the National Renal Healthcare Program In October 2004, a pilot program for kidney health was launched, targeted at the users of State Health Services in Montevideo and financed by the FNR [42]. Its general goal was to enhance kidney healthcare. Its specific goals included: (1) to promote education on kidney healthcare and a healthy lifestyle among the general population, with a view to reducing prevalence of cardiovascular and renal risk factors; (2) increase accessibility to kidney healthcare at the primary level; (2) promote early diagnosis of CKD among the population at risk; (3) enhance care given to patients at all stages of CKD; and (4) prevent cardiovascular morbidity and mortality, which are high in the targeted population [43].

8.2  Methodology for developing and spreading the NRHP In 2004, authorities of the Department of Health determined the need for an ACRH, which should be composed of representatives from the FNR, the SUN (Universidad de la República) Medical School and the Nephrology Department, and

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a delegate from the Department of Health [44,45]. This committee would pursue the implementation of a pilot program which included an Educational Program for primary care physicians (PCPs), supervised by the SUN Continuous Education Committee. The program consisted of the development of clinical guidelines for identification, evaluation, and management of patients with CKD at primary care level [46]. These guidelines were given to PCPs in several educational meetings. For developing a pilot program, it was decided that “Kidney Care Teams” would be constituted to work in all primary care centers. Each team would have a nephrologist, a dietitian and a nurse, and they would treat patients referred to them by the PCPs, or directly by the laboratory whenever the estimated glomerular filtration rate (eGFR) was lower than 60 mL/min/1.73 m2 (estimated by four variables MDRD equation), the urinary proteinuria/creatinine ratio was higher than 300 mg/g, or the albuminuria was higher than 30 mg in patients with diabetes. Regarding consultation with nephrologists and dietitians, it was estimated that 2 h of attendance per week for every 10,000 persons aged 20 and above would be necessary, at a productivity of four patients per hour. The frequency of nephrology visits in a referral and counter-referral system would depend on the CKD stage, with a minimum of one or two clinical visits per year in stable patients with CKD stage I–III. The teams operating in primary care centers worked jointly with a referral center for advanced CKD patients. Patients with CKD stage IV-V were referred to a CKD advanced clinic at tertiary care level, staffed by a formal multidisciplinary team (nephrologists, dietitians, nurses, psychiatrists, vascular surgeons, and social workers) which was committed to educating and providing social and psychological support. Before dialysis initiation, treatment options were explained in order to decide what dialysis modality would best suit the patient in question. A peritoneal catheter insertion or the timely creation of a permanent vascular access for dialysis was planned. For advanced CKD patients, 1 h of medical attention for every 10,000 persons aged 20 and above was estimated, with a productivity of 2 patients per hour. Simultaneously, an online CKD Registry was created and located in the FNR. Patients were entered in the registry whenever eGFR was lower than 60 mL/min/1.73 m2 (initially by MDRD 4 equation), or when persistent proteinuria higher than 300 mg/day (or microalbuminuria higher than 30 mg/day in diabetic patients) was present. This CKD Registry had a centralized “alarm system” which is activated whenever patients failed to keep an appointment in order to minimize failure to follow-up. These patients were called and scheduled for another appointment by a FNR social worker. Since implementation of the pilot program in the Public Health System, the FNR has provided renoprotective medications (ACE inhibitors, ARB blocker), diuretics, and statins, as well as hypoglycemic drugs for diabetic patients [46]. In the years following the implementation of the pilot program, important changes took place at the Health System in Uruguay. A National and Integrated Healthcare System was developed in 2007, prioritizing primary care, with a dual private (social security included) and public system. The pilot program slowly expanded into the public health system in Montevideo and then gradually to the rest of the country. Even though the Kidney Disease Prevention Program is not yet mandatory for every healthcare provider, the feasibility of incorporating kidney healthcare as a mandatory service is being studied. Until that happens, the Department of Health and the FNR have agreed on important steps to extend the program’s reach. In order to encourage the inclusion of new nephrology groups and incorporate private healthcare institutions into the program, the FNR invited health providers to sign a formal agreement [47]. According to it, the FNR would provide the electronic support for the CKD patients registry, the teaching materials for the educational programs and hepatitis B vaccine and erythropoietin for patients with CKD stage IV-V or already on dialysis. The FNR also provides immediate financial support for RRT when required for incident dialysis patients. Healthcare institutions, on the other hand, would appoint a coordinator to be responsible for the registry, to ensure patients’ access to nephrological and dietitian care and to renoprotective drugs, and to ensure planned dialysis initiation, including the placement of permanent vascular access. In 2007, a Department of Health decree declared of public interest the Creatinine Standardization Program proposed by the Alliance of Community Health Plans, following the recommendations of the National Kidney Disease Education Program Laboratory Working Group [48]. The program consisted in shipping several frozen serum samples with three different levels of creatinine to more than one hundred clinical laboratories around the country, and to a regional reference laboratory located in Argentina (LARESBIC), where the actual value would be determined. As part of the standardization program, random error, systematic error, and total error were estimated. Biological variability was used to set analytical quality requirements, with a maximum total error of 10.4%. In the three subsequent shipments of frozen serum samples, a reduction in the mean value of total error and random error was achieved (as a result of comparing paired samples). Samples with higher levels of creatinine achieved the total error goal more frequently. As for the samples with lower serum creatinine levels, there was an increase in the percentage of laboratories which achieved the total error goal: from 15.3% to 68.3% in samples with low serum creatinine levels (0.8 mg%), and from 35.6% to 82.8% in samples with intermediate serum creatinine levels. Furthermore, the application of the correction factor obtained by linear regression from five levels of creatinine (standardization of serum creatinine)

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enabled a reduction in the variability between laboratories (significant reduction of standard error and standard deviation). The percentage of laboratories which achieved the random error goal increased from 14.3% to 41.8% in samples with low creatinine levels (0.8 mg%), and from 33.8% to 59.3% in samples with intermediate creatinine levels (1.5 mg%) [49]. The creatinine standardization program has boosted NRHP’s confidence in CKD diagnosis. In addition, the reference laboratory has implemented the Uruguayan experience at regional level, mostly in some Argentine provinces.

9  INCLUSION OF CKD SCREENING IN THE MANDATORY HEALTH CHECK-UP CKD screening is progressively being incorporated into heath check-ups [50]. In Uruguay, since 1976, a regular health check-up is mandatory once every 2 years for students, individuals with a stable job and people who play sports. In 2006, the ACRH received an ISN grant for developing a CKD screening program in high-risk populations and a serum creatinine standardization program (described earlier). Following a pilot study which the ACRH conducted in 2009 at the State Preventive Medicine Clinics, the Department of Health passed a decree which provided for serum creatinine tests to be included in diabetic and hypertensive individuals’ Health check-ups. Patients who were positive for urine abnormalities or high serum creatinine levels according to these health check-ups would be referred to PCPs or nephrologists to complete their evaluation [51]. To increase homogeneity, a national consensus on proteinuria was reached between the country’s nephrologists and laboratories [52]. Between January 1, 2009 and December 12, 2012, 103,966 check-ups were performed on 83,912 people with a mean age of 34.1 (range 15–89 years of age), of whom 95.9% were under 60 years of age and 52.2 % females. Among this young population, prevalence of hypertension was of 16.4% and prevalence of diabetes was of 3.9%; proteinuria was found in 6.7% [53]. Just as in other groups, prevalence of both hypertension and diabetes increased with age and body mass index. The 11,161 persons (including those of the pilot study) who were tested for serum creatinine levels may be divided into four groups: (1) people with hypertension but without diabetes (5216, 46.7%); (2) diabetic people without hypertension (881, 7.9%); (3) people with diabetes and hypertension (1689, 15.1%); and (4) people with neither diabetes nor hypertension (3375, 30.2%). The last group was chosen as reference for estimating CKD risk. For this analysis, estimation of GFR was done using CKD-EPI equation [54]. CKD prevalence was higher in people with diabetes and hypertension (16.9%) followed by those with diabetes and without hypertension (11.9%) (Table 33.1).

10  EVALUATION OF THE CKD PROGRAM; THE CKD REGISTRY The target population is the Uruguayan adult population aged 20 and above. The variables included in the registry have already been described [55]. Between October 1 and December 31, 2014, 17,254 patients were entered, with a mean of 2,000 new patients per year for the past 5 years. Five thousand had undergone one medical follow-up per year during the past 5 years. The patients’ mean age was 66 ± 14 years, out of which 59.8% were 65 or above, and 47.6% were female [56]. The most frequent diagnoses were vascular nephropathy (40.8%), diabetic nephropathy (19.1%), obstructive nephropathy (7.9%), and primary glomerulonephritis (4.8%). The most frequent risk factors for kidney disease were: hypertension (86.9%), dyslipidemia (54.2%), diabetes (37.3%), and obesity (37.7%). The majority of patients were referred to a nephrologist at CKD stage III (61.4%), followed by stage I–II (16.9%), and stage IV-V (21.7%). The latter were considered late referrals. Every year, the ACRH carries out an annual evaluation and invites all the nephrology groups included in the NRHP. Group coordinators meet to discuss the progress of clinical indicators, and each group is given the results of their performance on

TABLE 33.1 Patients With Suspected Chronic Kidney Disease in the Health Check-Up Proteinuria Alone (%)

eGFR < 60 mL/min

Proteinuria + Reduced eGFR

No diabetes or hypertension

4.8

0.6

5.3

Hypertension without diabetes

6.8

2.3

8.5

Diabetes without hypertension

10.2

1.2

11.9

Diabetes and hypertension

14.9

2.8

16.9

Total

7.7

1.8

9.0

eGFR, estimated glomerular filtration rate.

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TABLE 33.2 NRHP Quality of Care Indicators Indicator

Goal

Process indicators Percentage of pts included in Dialysis Registry previously registered in CKD Registry

60%

Percentage of pts included in Dialysis Registry previously seen with a nephrologists for at ≥1 year

60%

Number of pts/10,000 population over 20 years old, entering the program per year

24

Number of pts/10,000 population over 20 years old, controlled per year

35

Percentage of pts controlled within those entered in the last year

90%

Percentage of diabetic pts with at least one glycemia or glycated hemoglobin registered

90%

Percentage of pts with proteinuria over 0.5 g/g creatinina using RAS block drugs

80%

Percentage of pts with LDL cholesterol over 100 mg/dL using statins

60%

Percentage of pts with early referral (eGFR > 30 ml/min)

80%

Result indicators Percentage of pts with systolic blood pressure < 140 mmHg

60%

Percentage of pts with diastolic blood pressure < 90 mmHg

80%

Percentage of pts with BMI 18.5–24.9 kg/m2

40%

Percentage of pts with cholesterol < 200 mg/dL

60%

Percentage of pts with LDL cholesterol < 100 mg/dL

50%

Percentage of pts with bicarbonate ≥ 23 mEq/L

70%

Percentage of pts that loose < 1 mL/min/year eGFR

50%

Percentage of diabetic pts with HbA1c < 7%

50%

Indicators in advanced CKD pts Percentage of pts with serum phosphorus < 4.6 mg%

80%

Percentage of pts with 25 vit D measure

70%

Percentage of pts with iPTH measure

70%

Percentage of pts with B hepatitis vaccine

50%

Percentage of pts with influenza vaccine

50%

Percentage of pts with pneumococcous vaccine

50%

Outcome indicators Death rate (N/pts-years *100)

< mean +2 SD

ESRD rate (N/pts-years *100)

< mean +2 SD

Death + ESRD rate (N/pts-years *100)

< mean +2 SD

BMI; Body mass index; eGFR, estimated glomerular filtration rate; ESRD, end-stage renal disease; iPTH, intact parathyroid hormone; LDL, low density lipoprotein; N, number; Pts, Patients; Vit D, Vitamin D.

each indicator, as well as the median and percentiles 25–75 of the program. This meeting is important in order to address each group’s strengths and weaknesses, as well as to assess the program as a whole [57]. Table 33.2 shows the indicators used in the evaluation, including process and results indicators. One of the most outstanding results was that patients who entered dialysis having been previously registered in the CKD Registry increased from 1% in 2005 to 49.5% in 2015.

11  UNIVERSALIZATION OF THE CKD PROGRAM AND REGIONAL EXPANSION The International Society of Nephrology has made contact with the WHO on several occasions to increase worldwide awareness of CKD and to get governments involved in prevention and treatment. The Latin American Society of Nephrology and Hypertension (SLANH, for its acronym in Spanish) has been even more successful in its approach to PAHO, as it achieved a declaration that all countries should improve care and coverage of dialysis treatment [58]. Not all Latin

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American countries are at the same level regarding CKD care, which is why the SLANH and PAHO are to launch an online course on CKD prevention and care on July 2016, targeted at PCPs from all over Latin America (in Spanish and Portuguese), through PAHO’s virtual space. The Uruguayan and Bolivian Departments of Health together with the SLANH have launched a cooperation project to increase development of kidney healthcare in Bolivia, with the aim of improving the tools needed for Dialysis Registry and developing a prevention program [59]. The Santa Fe Province Prevention Program and the NRHP are currently studying the possibility of an experience-sharing initiative. In 2015, the Uruguayan Department of Health defined its health goals for 2016–2020. Most of them are related to NCDs (diabetes, hypertension, cardiovascular, and cerebrovascular disease), and one of them was the determination that healthcare providers should incorporate their hypertensive and diabetic patients into the NRHP and enter them in the CKD Registry [60].

12 CONCLUSIONS CKD is a global public health problem, expected to increase alongside population ageing in both developed and developing countries. Its management requires a commitment by the nephrology community to provide guidelines for systematic screening and follow-up, and the involvement of national health authorities, which should set a framework for healthcare providers to ensure universal healthcare coverage and treatment continuity from the early stages of CKD and up until dialysis and renal transplantation. Uruguay is a small country with universal health coverage, which as of 1981 covers dialysis and with a CKD screening and prevention program that started in 2004 with a pilot program and is currently being incorporated into the mandatory health programs, with a view to its universalization. Policies reducing out-of-pocket costs for chronic disease care are required to encourage patients to stay in treatment, thereby reducing and/or preventing progression to ESRD. It is likewise important to establish programs and or policies to reduce cardiovascular events and death that are associated with CKD progression.

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FURTHER READING Objetivos Sanitarios Nacionales, 2010. Available from: http://www.anii.org.uy/upcms/files/llamados/documentos/objetivos-sanitarios-nacionales-2020.pdf