Kidney Early Evaluation Program KEEP. A n n u a l D a t a R e p o r t

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1 Kidney Early Evaluation Program KEEP A n n u a l D a t a R e p o r t

2 The National Kidney Foundation gratefully acknowledges the support of our primary sponsor and our associate sponsors Additional thanks to Novartis Pharmaceuticals Corporation, Bayer Healthcare, Satellite Healthcare, Satellite Laboratory Services, LifeScan, Inc. and Ocean Spray Cranberries, Inc.

3 E E xecu ti ve summar y Thank you so much for the free screening. The results have been helpful to me and my doctor. As a result, my doctor knew what other things we needed to look at and do further testing on. Thanks again! I would recommend everyone with diabetes or hypertension be tested. KEEP participant: Screening date, October 25 he emergence of chronic kidney disease (CKD) as a major public health problem has placed increased pressure on the health care system to address this condition. There is little doubt now that CKD and its staging provide valuable predictive information on likely complications from cardiovascular disease and on increased mortality, and CKD appears to be a potent risk multiplier in those with diabetes and hypertension. The fact that an individual with CKD is 2 5 times more likely to die than to reach end-stage renal disease (ESRD, requiring dialysis or a kidney transplant) places this condition in a unique perspective. The public health implications of CKD were recently highlighted with the first World Kidney Day, on March 9, 26. The second annual event, on March 8, 27, will draw further attention to the disease as a worldwide public health problem. In the United States, the ever-growing number of ESRD patients and the pressure they place on the health care delivery system has led to a number of public health initiatives to address the feeder population. As one of these initiatives, the National Kidney Foundation s Kidney Early Evaluation Program (NKF KEEP), like any strong public health program, includes surveillance and detection components to assess the burden of disease and to promote early identification and intervention. KEEP addresses community awareness of CKD, using simple tests to define Executive summary s

4 the population and to demonstrate both the high burden of complicating conditions and the lack of implementation of available and effective treatments. The program s educational materials, sent to each participant and his or her physician provider, have a dual purpose to improve the care of individual participants, and to encourage providers to address similar patients in their practices, thereby expanding the program s impact. Concern about the public health issues related to CKD has reached into the Centers for Disease Control and Prevention, which recently awarded a grant to the NKF and researchers from the University of Minnesota to develop a state-level CKD detection program modeled after the KEEP system. The CDC also awarded researchers at the University of Michigan and Johns Hopkins, grants to develop a national CKD surveillance program. These efforts, along with the new ICD-9-CM diagnosis codes incorporating the NKF CKD staging system will help providers, health plans, and Medicare determine the disease prevalence and degree of care found in this vulnerable population. To augment these public health initiatives, this annual report on the KEEP program provides a summary of important findings from a large-scale CKD detection effort. This year s report summarizes program activity through December 31, 25, when 55,22 individuals had met the criteria of having self-reported diabetes or hypertension or a family history of diabetes, hypertension, or kidney disease. The program has expanded across the entire country, with the eastern and southeastern portions of the country contributing the greatest percentage of individuals. Compared to the general population, KEEP participants are older, more likely to be female (68%), and three times more likely to be African American. They are, as expected, more likely to have diabetes (26% versus 6% in the general population) and hypertension (53% versus 25%). Individuals coming to the program are within the high-risk group for kidney disease, and their burden of CKD is far higher than that found in the general population (29% versus 13%). Most revealing is the fact that only 2% know they have evidence of kidney disease, yet results of urine microalbuminuria testing and findings of an egfr less than 6 ml/min/1.73 m 2 identify the disease in 29% of participants. This is quite remarkable, and demonstrates the value of using simple tests to identify kidney disease in those with existing diabetes and hypertension. Also remarkable is the finding that those factors placing individuals at risk for cardiovascular disease and mortality are very common and very treatable. Obesity, for example, is far more widespread in KEEP participants than in the general population unsurprising, to some extent, as the targeted group has a high burden of diabetes and hypertension. As expected, the prevalence of these diseases increases with BMI. While this lifestyle issue clearly demands more attention, and is not a new finding, the degree of obesity is quite revealing. In addition, blood pressure control is far less than optimal, with only one in four participants with diabetes or CKD meeting the target of less than 13/8. And in participants with diabetes, glycemic control is a further problem. Fewer than half have a blood sugar level below the target set by the American Diabetes Association. In this year s report we have added new information on the degree of kidney disease, using two different definitions: the more basic one of a positive urinary albumin level greater than 2 mg/l, and the more comprehensive definition of a urinary albumin to creatinine ratio greater than 3 mg/gm. In providing this measure we have calibrated the serum creatinine to the Cleveland Clinic Laboratory standard to validate the utilization of the MDRD estimating equation for GFR. Based on the first definition, 57.4 % of KEEP participants have evidence of kidney damage. Using the more stringent criterion, that number drops to 29%. While lower, this is still six times greater than the number identified using only a simple serum creatinine test, demonstrating the value both for individual patients and on the level of public health of more comprehensive assessment. Other important new findings include the degree of hyperparathyroidism in KEEP participants with an egfr less than 6 ml/min/1.73 m 2. There appears to be a stepwise increase in PTH levels as egfr falls below 6, confirming findings from other investigators that hyperparathyroidism is common and begins in the early stages of CKD. Interestingly, the degree of anemia also correlates with the degree of secondary hyperparathyroidism, suggesting a potential interaction of these complicating conditions in people with CKD. Some investigators have suggested that there may be a link between the inflammatory cytokine abnormalities noted in secondary hyperparathyroidism and the degree of anemia, which may also be mediated through bone marrow resistance to erythropoietin. It is interesting to see that findings of anemia, hyperparathyroidism, and inflammation appear very early in CKD, showing that they are more common than previously appreciated. In Stage 3 CKD, anemia itself, as previously s National Kidney Foundation Kidney Early Evaluation Program 26

5 reported, is twice as common in those with a diagnosis of diabetes as in those without. In those with Stage 4 CKD the prevalence approaches 6%, with the same differential in the diabetic and non-diabetic populations. In 27 the KEEP effort will enter a new phase, as a followup system is created for field operations and more comprehensive assessments are developed of cohort outcomes related to access to care. Additional tests are also being considered: hemoglobin A1c, to assess glycemic control; direct LDL and HDL cholesterol levels, to assess risk factors for cardiovascular disease; and tests of other inflammatory markers, such as white blood cell counts. This report marks a transition in the KEEP Steering Committee. Members have served more than four years, guiding the program through its growth and development and overseeing its publications. The new committee will be installed by January, 27, and will lead the program s focus on CVD and diabetes and on major populations with CKD. The follow-up phase will receive extensive review as it is implemented. This year s World Kidney Day is a perfect time to advance the awareness of CKD and its implications for those with diabetes and hypertension. Detection programs are needed worldwide, as are the kind of surveillance programs already existing for diseases such as diabetes and cardiovascular disease. The KEEP effort is now developing in other countries, with the first collaborative detection program between the U.S. KEEP program and the International Kidney Evaluation Association of Japan (IKEAJ) starting in June, 26. We look forward to working with other countries as they begin their own detection and surveillance programs to address CKD and to reduce its high comorbidity and mortality. Executive summary s5

6 program accessibility All Age ,4 1,85 1,389 4, ,491 1,977 2,393 2,94 3,98 12, ,97 2,652 3,422 4,691 6,41 19, ,52 2,29 2,381 3,327 4,737 13,976 > ,81 1,541 4,51 Gender Male 1,959 2,57 2,944 4,144 5,851 17,468 Female 4,123 5,474 6,975 8,979 12,124 37,675 Missing Race White 2,284 3,14 4,31 5,791 9,5 24,485 Black 2,652 3,393 3,43 4,279 5,221 18,975 Other 967 1,358 1,85 2,973 3,43 1,551 Unknown/missing ,29 Ethnicity Non-Hispanic 5,464 7,333 8,85 11,233 15,642 48,477 Hispanic ,116 1,891 2,46 6,743 Education Level < 6 years ,44 3,125 <12 years ,189 1,774 5, years 1,585 2,193 2,59 3,49 4,597 14,455 >12 years 1,629 2,155 2,775 3,461 4,663 14, years 1,143 1,463 1,913 2,53 3,67 1,656 >16 years ,132 1,47 2,133 6,285 Missing Health Insurance Status Yes 4,948 6,429 7,892 1,154 15,279 46,869 No ,554 1,71 2,353 6,84 Missing ,288 All 6,82 8,45 9,921 13,124 18,48 55,22 e.a Total eligible KEEP participants KEEP N= 55,22. s6 National Kidney Foundation Kidney Early Evaluation Program 26

7 cumulative # of partic. (in 1,s) e , Cumulative # of affiliates Cumulative number of KEEP participants & affiliates, by year e (5.26) 2.32 to < to < to <.88 below.11 (.3) Geographic variations in the percent of KEEP participants, by state KEEP N=55,2 Florida Virginia South Carolina MA/RI/NH/VT North Carolina Indiana Louisiana Oklahoma East Tennessee Eastern/Met-East MO Hawaii Connecticut Georgia Central New York Arizona Illinois Kentucky Western Pennsylvania Mississippi New Mexico Greater New York Western New York Utah Delaware Valley North Texas Northeast New York Nebraska South/Central Texas Middle Tennessee Maine West Tennessee Minnesota Upstate New York Iowa Ohio Northern California West Texas Alabama Arkansas South Dakota Kansas/Western MO Oregon/Washington Southern California National Capital Area Southeast Texas Michigan CO/ID/MT/WY Wisconsin e Percent of participants Percentage of KEEP participants, by affiliate (rank order) KEEP N=55,22 he KEEP program is designed to identify individuals with a history of diabetes or hypertension and those with a family history of diabetes, hypertension, or kidney disease. As of December 31, 25, the program had screened 55,22 participants. The greatest proportion of these participants are age Twice as many women compared to men have been screened by the KEEP program. And over 24, whites have taken part in the screening, compared to nearly 19, blacks and 11, Hispanics. In 25, screening programs were conducted by 48 affiliates, the majority located in the southern portions of the U.S. Seven percent of participants reside in Florida and 5% in Virginia, South Carolina, or New England. Executive summary s7

8 targeting high-risk populations Percent with self-reported DM Age 37.4 Gender Race/ethnicity KEEP NHANES All Male Female White Black Other Hisp e.4 Self-reported diabetes in KEEP & NHANES participants, by age, gender, & race/ethnicity KEEP N= 55,22, age & Hispanics; 55,143, gender; 54,11, race. NHANES N= 11,432. Percent with self-reported HTN Age 76.9 KEEP NHANES All Gender Race/ethnicity Male Female White Black Other Hisp e.5 Self-reported hypertension in KEEP & NHANES participants, by age, gender, & race/ethnicity KEEP N= 54,56, age & Hispanics; 54,433, gender; 53,353, race. NHANES N= 11,271. s8 National Kidney Foundation Kidney Early Evaluation Program 26

9 % with cardiovascular disease Age 17.9 All Gender Race/ethnicity Male Female White Black Other Hispanic e.6 Cardiovascular disease in KEEP participants, by age, gender, & race/ethnicity KEEP N= 54,173, age; 54,111, gender; 53,3, race. KEEP NHANES 99-2 OW: 32.9 N: 21.7 N: 33.6 UW:.8 EO: 8.8 UW: 2. OW: 34.2 EOB: 4.9 OB: 35.8 OB: 25.3 e.7 Percent distribution of KEEP & NHANES participants, by BMI category KEEP N= 54,466. NHANES N= 1,132. ver 25% of KEEP participants report having diabetes. Rates of diabetes increase with age up to age and reach 37.4% in this age group. Equal proportions of men and women report having diabetes. By race and ethnicity diabetes is reported by 26.3, 24, 28.2, and 25.9%, respectively, of whites, blacks, people of other races, and Hispanics. Self-reported hypertension is far more common in the KEEP population compared to the general population. Overall, 52.8% of KEEP participants report having hypertension compared to 25% of the NHANES population. The proportion of participants reporting hypertension increases with age, and reaches 76.9% in KEEP participants age 75 and older. Rates of hypertension are similar by gender, and in both the KEEP and NHANES populations are highest in blacks at 56.5 and 36%, respectively. Not surprisingly, rates of cardiovascular disease (CVD) in KEEP participants increase with age. CVD is evident in 16.6% of participants age 46 6, while 25.9% of those age and 35.2% of those age 75 and older are afflicted with the disease. By, gender, CVD is found in 18.7% of males and 17.5% of females. Twenty percent of white participants have CVD compared to 17% of blacks and to 15.5 and 15.1%, respectively, of people of other races and Hispanics. Nearly a third of KEEP participants are classified as being overweight, while 35.8% are obese, and 8.8% are extremely obese. Executive summary s9

10 prevalence of ckd 8 Age Gender Race/ethnicity Percent with CKD KEEP NHANES 99-2 All M F W B Oth Hisp Percent with CKD Old CKD staging definition New CKD staging definition All CKD Stage 1 Stage 2 Stage 3 Stage 4-5 e.8 CKD in KEEP & NHANES participants, by age, gender, & race ethnicity KEEP N= 45,311, age & gender; 44,4, race. NHANES N= 9,718. e.9 CKD in KEEP participants, by CKD stage & CKD definition KEEP N= 45, Percent with CKD 1 5 New CKD staging definition Percent of participants KEEP NHANES 99-2 e.1 All CKD Stage 1 Stage 2 Stage 3 Stage 4-5 CKD in NHANES participants, by CKD stage & CKD definition NHANES N= 45,311. e.11 All CKD NCKD CKD+ CKD+ CKD+DM CKD+Oth DM HTN +HTN Interactions of CKD, diabetes, & hypertension in KEEP & NHANES participants KEEP N= 44,925. NHANES N= 9,599. ome form of chronic kidney disease (CKD) is known to exist in nearly 13, of the over 45, (28.7%) eligible KEEP participants for whom data on estimated glomerular filtration rates are available. Stage 3 CKD (egfr 3 59) is most apparent among these individuals, at 19.7%, with Stage 1 and Stage 2 accounting for 3. and 4.8% of participants, respectively. Evidence of CKD increases with age, reaching 41% in KEEP participants age and 58% in those age 75 and older. Twenty-seven percent of men have some form of CKD compared to 29.3% of women. By race/ethnicity, CKD is present in 32.4% of whites, 25% of blacks, and 25.6% of individuals of other races; the disease affects 22.5% of eligible Hispanic KEEP participants. s1 National Kidney Foundation Kidney Early Evaluation Program 26

11 Stage 1& Stage 2& Non-CKD Abnormal ACR Abnormal ACR Stage 3 Stages 4-5 Missing All Age , ,31 4, , ,642 12, , , ,593 19, , , ,123 13,976 >75 1, , ,51 Gender Male 1, , ,272 17,468 Female 21, ,431 6, ,56 37,675 Missing Race White 14, , ,512 24,485 Black 1, , ,447 18,975 Other 6, , ,652 1,551 Unknown/missing ,29 Ethnicity Non-Hispanic 28,13 1,18 1,911 8, ,752 48,477 Hispanic 4, ,157 6,743 U.S. Census Region Northeast 7, , ,73 12,843 Midwest 5, ,4 96 1,262 8,88 South 15, ,31 4, ,478 27,239 West 3, , ,87 6,31 Missing U.S. Census Division New England 2, , ,25 5,39 Middle Atlantic 4, , ,534 East North Central 3, ,643 West North Central 2, ,165 South Atlantic 7, , ,298 14,79 East South Central 4, ,391 West South Central 3, , ,278 6,769 Mountain 2, ,754 Pacific 1, ,556 Missing Smoking Yes 12, , ,989 22,267 No 17, ,96 4, ,258 29,719 Missing 1, ,234 Education Level 6 years 1, ,125 <12 years 2, , , years 8, , ,56 14,455 >12 years 8, , ,69 14, years 6, , ,897 1,656 >16 years 3, ,125 6,285 Missing Health Insurance Status Yes 25, ,672 7, ,835 43,423 No 5, , ,676 9,59 Missing 1, ,288 Doctor Status Yes 26,951 1,129 1,871 8, ,346 46,869 No 4, ,254 6,84 Missing ,547 All 32,317 1,383 2,167 8, ,99 55,22 e.b Total eligible KEEP participants with chronic kidney disease, by CKD stage All includes participants with missing or unknown values for data fields. Executive summary s11

12 ckd as a disease multiplier KEEP: CKD NHANES 99-2: CKD Prehypertension: 35.6 Stage 1: 3.6 Normal: 14.2 Stage 2: 19.6 Prehypertension: 36.9 Normal: 34.3 Stage 2: 11.5 Stage 1: 17.4 KEEP: No CKD NHANES 99-2: No CKD Prehypertension: 41.3 Stage 1: 26.6 Normal: 2.8 Stage 2: 11.2 Prehypertension: 36.9 Normal:46. Stage 2: 4.5 Stage 1: 12.6 e.12 Percent distribution by hypertension stage (JNC 7) in KEEP & NHANES participants with or without CKD KEEP N= 44,673. NHANES N= 9,4. Percent with self-reported HTN KEEP Gender Race/ethnicity NHANES 99-2 CKD No CKD 4 2 * All Male White Other Female Black Hisp. e.13 Self-reported diabetes in KEEP & NHANES participants with or without CKD, by age, gender, & race/ethnicity KEEP N= 44,925 age & gender; 44,41, race/ethnicity. NHANES N= 9,714. *Sample size less than 3 or coefficient of variation not less than 3%. s12 National Kidney Foundation Kidney Early Evaluation Program 26

13 6 KEEP: Age Gender 4 Percent with BMI>= 3kg/m NHANES 99-2 CKD NCKD All Male Female Percent of participants with anemia WHO anemia All CKD No CKD K/DOQI anemia KEEP NHANES 99-2 All CKD No CKD e.14 BMI 3 kg/m 2 in KEEP & NHANES participants with & without CKD, by age KEEP N= 44,711. NHANES N= 9,459. e.15 Anemia (WHO & K/DOQI definitions) in KEEP & NHANES participants, by CKD status KEEP N= 44,723. NHANES N= 1,18, all, 9,712 CKD. nder blood pressure criteria established by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7), 14.2% of KEEP participants with CKD have normal blood pressure levels, 35.6% have prehypertension, and 3.6 and 19.6%, respectively, have a hypertension classification of Stage 1 or Stage 2. Nearly 7% of eligible KEEP participants with CKD report having diabetes. Diabetes affects older participants to a greater degree approximately 8% of participants older than 6 report having diabetes, compared to 31% of those age 18 3 and 41% of those age Rates of self-reported diabetes are similar in males and females, at 71 and 69%, while 75% of blacks report the disease, compared to 68, 66, and 63%, respectively of whites, individuals of other races, and Hispanics. The percent of KEEP participants classified as obese is similar in those with and without CKD. In KEEP participants with CKD, those age 46 6 are the most prone to obesity, followed by those age Females are more likely than males to be obese, regardless of CKD status. Using the WHO and K/DOQI definitions of anemia, 11 and 7.4% of KEEP participants are classified as anemic. In those with CKD, proportions reach 17.3% when using WHO criteria, and 12.9% when the K/DOQI definition is applied. In participants not carrying a CKD diagnosis, rates are 9.6 and 5.2%, respectively. Executive summary s13

14 Table e.a As of 25, 55,22 individuals have participated in the KEEP screening program. By race, 24,485 whites have participated compared to 18,975 blacks and 1,551 of other races. Figure e.4 Over one-quarter of eligible KEEP participants report having diabetes or diabetic retinopathy. Rates are highest in older participants and in people of races other than white or black. Figure e.5 The proportion of KEEP and NHANES participants who report being hypertensive increases with age, is comparable in males and females, and is slightly higher in blacks compared to whites, individuals of other races, and Hispanics. Figure e.6 Over 17% of KEEP participants report a history of cardiovascular disease. Rates are most pronounced in older participants, reaching 35% in those age 75 and older. Rates are slightly higher in whites compared to those of other racial and ethnic groups. Figure e.8 Twenty-nine percent of KEEP participants have CKD compared to 13% of the NHANES population. CKD is evenly distributed between males and females in both populations, and occurs most often in whites. Figure e.9 Using the new CKD definition, the percent of KEEP participants with CKD is 28.7%, compared to 57.4% under the old definition. Figure e.12 Among KEEP participants with or without CKD, 35.6 and 41% are prehypertensive, respectively, while in the NHANES population, 36.9% have this condition. Figure e.13 In both the KEEP and NHANES populations, self-reported diabetes is more prominent in those with CKD at 36.1% and 15.7% respectively compared to those without the diagnosis. JNC 7 Hypertension Normal systolic <12 mmhg & diastolic <8 mmhg Prehypertension systolic mmhg or diastolic 8-89 mmhg Stage 1 systolic mmhg or diastolic 9-99 mmhg Stage 2 systolic 16 mmhg or diastolic 1 mmhg Diabetes Self-reported diabetes Elevated blood sugar Glucose greater than the normal limit Fasting: >126 mg/dl Non-fasting: >139 mg/dl CVD definition: KEEP Participant reporting any of the following cardiac events: heart attack, heart by-pass surgery, heart angioplasty, stroke, heart failure, stroke, PVD, or arrhythmia CVD definition (NHANES) Participant reporting any of the following cardiac diseases: congestive heart failure, coronary heart disease, angina/angina pectoris, heart attack, or stroke CKD Definition If egfr by K/DOQI MDRD <6 ml/min/1.73 m 2 or egfr 6 ml/min/1.73 m 2 and abnormal albumin/creatinine ratio (ACR 3mg/g) CKD Stages Stage 1: egfr 9, ACR 3 mg/g Stage 2: egfr 6 89, ACR 3 mg/g Stage 3: egfr 3 59 Stage 4: egfr Stage 5: egfr <15 or dialysis Body Mass Index Categories UW: underweight, BMI <18.5 N: normal, BMI OW: overweight, BMI OB: obese, BMI EOB: extremely obese, BMI 4 Anemia Definitions WHO Male: hemoglobin <13 g/dl Female: <12g/dl K/DOQI Males: hemoglobin <12g/dl Women age >5: <12g/dl Women age 5: <11 g/dl s14 National Kidney Foundation Kidney Early Evaluation Program 26

15 1 I n t ro d u c tio n I learned through the screening that I had diabetes and [high] cholesterol. I am now being treated by an endocrinologist. Thank you for providing this free service to our community. KEEP participant: Screening date, August 25 C hronic kidney disease is receiving increased attention in the United States and around the world as the precursor to ESRD, a disease requiring treatment with dialysis or transplantation. The growing number of people entering ESRD therapy has placed increased demands on patients, families, and health care resources worldwide. During the past three decades, with ESRD approved for Medicare coverage under Medicare entitlement, the U.S. has led the world in treated incident and prevalent rates. These rates are now being eclipsed, however, by those of other countries, particularly Japan and Taiwan. Taiwan now has the highest incident rates of ESRD in the world, with the United States second and Japan third. Prevalent rates of treated ESRD also show Japan to be first, followed by Taiwan and the U.S. These high rates of ESRD have placed increasing strain on health care budgets, as ESRD consumes an ever-increasing part of health care expenditures. The KEEP program Ten years ago, the NKF created strategies for targeting populations at high risk of kidney disease. Preliminary studies during for the subsequent KEEP were conducted on almost 9 individuals, and showed that targeted populations age 18 and older, with a history of diabetes or hypertension or with a family his- Chapter 1 Introduction s15

16 tory of these two diseases or kidney disease, were highly likely to have evidence of kidney damage, microalbuminuria, and reduced kidney function. In the latter part of 2 the NKF officially launched the KEEP program and expanded its initial 21-city pilot program to a national effort through its local affiliates. Now in its sixth year, the nationwide KEEP program has seen over 8, individuals, evaluating their blood pressures, height, weight, body mass index (BMI), evidence of kidney damage (through testing of urine for albumin and blood for elevated serum creatinine levels), evidence of anemia, and family history of diabetes, hypertension, and cardiovascular disease. The program provides educational materials to patients and families, as well as to physicians. Consultation with a physician is also available at the end of the program, allowing participants to review their family history and the results of their evaluation. This large effort has now expanded to 48 NKF Affiliates across 49 states, and has received attention worldwide through publication of the National Kidney Foundation s KEEP Annual Data Report. Administrative structure & oversight KEEP s organizational structure (right) has evolved along with the program itself. The program is governed by an External Advisory Committee, which receives significant input on program operations from the NKF Affiliates; there is also an Executive Committee chaired by Wendy Brown, MD, and Michael Klag, MD. The Executive Committee communicates monthly, discussing data coordinating center issues, ancillary studies, funding and sponsorship, affiliate support, new program development, and publications. Report. The data collection form for this reporting period was used through December 31, 25. Content of the Annual Data Report The size of the KEEP program allows this report to provide extensive descriptive characteristics of the population. Participant information is organized by age, gender, race, and, where possible, geographic region; we also present data on participant education, insurance coverage, and access to physician care in Chapter 2. External Advisory Committee Data Coordinating Center National Kidney Foundation NKF KEEP Chair:Wendy Brown MD Vice Chair: Mike Klag MD, MPH Ancillary Studies Steering Committee Executive Committee Funding and Sponsorship Affilliate Support NKF Affilliates Publications Program Development and Evaluation National Kidney Foundation KEEP Organizational Chart The KEEP Steering Committee works with the Data Coordinating Center and NKF Affiliates on analyses of the KEEP data and on the Annual Data Report. Committee members (see box on next page) have a broad range of expertise, and include experts in nephrology, hypertension and cardiovascular disease, cardiology, diabetes, and minority populations. Members include representatives from the CDC, the Indian Health Service and the NKF. KEEP Data Coordinating Center Allan Collins, MD, Director Project Manager Shu-Cheng Chen, MS Data Coordinating Center Organizational Chart All KEEP data are submitted for entry to NKF s national office in New York; data are then sent to the KEEP Data Coordinating Center at the Minneapolis Medical Research Foundation in Minnesota, which is responsible for the KEEP Annual Data Data & Database Management Cheryl Arko, BS Frank Daniels, BS Eric Frazier, BS C. Daniel Sheets, BS Biostatistics Suying Li, MS Changchun Wang, MS Editorial Office Delaney Berrini, BS Edward Constantini, MA Susan Everson, PhD s16 National Kidney Foundation Kidney Early Evaluation Program 26

17 This year in Chapter 3, we provide information on the prevalence of diabetes, hypertension and cardiovascular disease. Data on obesity, a known risk factor for cardiovascular disease and diabetes are presented as well, in addition to information on participant smoking history, evidence of kidney disease, family history as it relates to comorbidity, and finally information on medical interventions following the KEEP evaluation. Chapter 4 provides information on diabetes and glycemic control in the KEEP population, as well as on hypertension and hypertension control. While over 25% of KEEP participants report having diabetes, 17.1% have evidence of diabetes based on blood sugar. And almost 7% of KEEP participants have evidence of hypertension 53% know they have the disease, and 52% discover it through an elevated blood pressure measured during participation in the program. KEEP Steering Committee *Wendy W. Brown, MD, MPH, FACP, FAHA: Chair Meharry Medical College, Vanderbilt University Medical Center *Michael J Klag, MD, MPH: Vice Chair Johns Hopkins University *Allan J. Collins, MD, FACP HennepinCounty Medical Center & University of Minnesota George Bakris, MD, FACP, FCP Rush Presbyterian, St. Lukes s Medical Center Nilka Rios-Burrows, MPH CDC Diabetes Translation Division, Indian Health Service Claudine Jurkovitz, MD, MPH Emory University School of Medicine Peter McCullough, MD, MPH William Beaumount Hospital Health Center Jane McGill, MD Washintion Universitiy School of Medicine Andrew Narva, MD, FACP Indian Health Service Kidney Disease Program Keith C. Norris, MD Charles R. Drew University Pablos Pergola, MD, PhD University of Texas Health Science Center at San Antonio Ajay Singh, MD Brigham & Woman s Hospital Leslie A Stevens, MD Tuft-New England Medical Center Ex-Officio Members Shu-Cheng Chen, MS Chronic Disease Research Group, Minneapolis Medical Research Foundation Joseph Vassalotti, MD, FASN Chief Medical Officer, NKF Laura Williams, MD, MPH Abbot Laboratories Marsha Wolfson, MD Ortho Bitotech Clinical Affairs NKF Staff Katherine Channing Managing Director, KEEP John Davis Chief Executive Officer Monica Ryan Gannon Early Intervention Program Director Gigi Politoski Vice President Program Director Leslie Gracz-Weinstein, RN Clinical Service Director, KEEP * KEEP Executive Committee Chapter 5 presents a more complete evaluation of findings related to (CKD) in the KEEP and general populations. We present information on CKD staging using the NKF classification of CKD which stipulates an egfr (K/DOQI MDRD) of less than 6 ml/min/1.73 m 2 or an egfr greater than or equal to 6 ml/min/1.73 m 2 and abnormal albumin/creatinine ratio ( 3 mg/g). We look as well at blood pressure control by CKD stage, and at diabetes, obesity, anemia, and multiple cardiovascular risk factors. The chapter also includes data on the prevalence of microalbuminuria and abnormal albumin/creatinine ratio by egfr stage, in diabetic and hypertensive populations. New this year is information on preponderance of abnormal parathyroid hormone (PTH), calcium, and phosphorus levels in KEEP participants with egfr less than 6, by diabetes, hypertension, and cardiovascular disease status additional information on these markers is presented by egfr level, CKD stage, BMI, and the presence of anemia. In Chapter 6 we present data on the prevalence of anemia, using anemia guidelines by both the WHO and the NKF s K/DOQI. Diabetes is a significant risk factor for anemia and data show an increased risk in blacks risk of anemia is fivetimes higher in blacks with diabetes in comparison to whites with no diabetes. Analytical methods & reference tables The analytical methods used in each chapter are described in the appendix. Reference tables have been expanded this year, and include data on self-reported diabetes and hypertension, elevated blood sugar and blood pressure, blood pressure control, evidence of chronic kidney disease, body mass indices, microalbuminuria, abnormal albumin/creatinine ratio, hemoglobin level, cardiovascular disease, self-reported kidney disease or stones. These tables provide a more complete description of the number of individuals and their distribution in each of these categories, overall, by race/ethnicity, and by NKF affiliate. Acknowledgements The KEEP program could not function without the extensive support of NKF volunteers across the United States who help each NKF Affiliate deliver this community service. The dedicated efforts of affiliate staff and the national office, providing support mechanisms to NKF Affiliates, are also extremely important. Sponsors of the KEEP program are listed at the front of the Annual Data Report; they provide affiliates with the necessary Chapter 1 Introduction s17

18 materials to carry out the program, and help support laboratory requirements, administrative support, and data analysis. We hope the information provided in this report will help demonstrate, in the United States and around the world, how a detection program can be used not only to identify populations with a high prevalence of a disease, but can also give additional insight into the quality of care and followup these individuals receive. Abbreviations Adjust ACR Arrhyth B BS BMI BP BPS CKD Crt CVD DBP DM egfr EBS El BP adjustment albumin/creatinine ratio arrhythmia black blood sugar body mass index blood pressure by-pass surgery chronic kidney disease creatinine cardiovascular disease diastolic blood pressure diabetic or diabetes estimated glomerular filtration rate elevated blood sugar elevated blood pressure ESRD F FH HA HF Hgb HTN JNC-7 KD M KEEP MDRD Nat Am NHANES end-stage renal disease female family history heart attack heart failure hemoglobin hypertension National Joint Committee on Preven tion, Detection, Evaluation, & Treatment of High Blood Pressure kidney disease male Kidney Early Evaluation Program Modification of Diet in Renal Disease Native American National Health & Nutrition Examination Study NKF NKF K/DOQI Non-DM NSR OTC Oth Pac Isl Partic PD PVD SBP SR W WHO National Kidney Foundation National Kidney Foundation s Kidney Disease Outcomes Quality Initiative non-diabetic non-self-reported over the counter other Pacific Islander participant peritoneal dialysis peripheral vascular disease systolic blood pressure self-reported white World Health Organization s18 National Kidney Foundation Kidney Early Evaluation Program 26

19 2 Pa r ticipant d e m o g raphic s My mother s kidneys failed and I know too well what that means. I was thrilled when I heard about the KEEP program. I am grateful for the opportunity to participate and be able to identify the risks I might have for developing kidney disease. I would like for my children not to have to see and go through what I did with my mother. Thank you! KEEP Participant: Screeening date, October 25 d e m o g r a p h i c s e d u c a t i o n i n s u r a n c e c o v e r a g e a c c e s s t o m e d i c a l c a r e Chapter 2 Participant demographics s19

20 demographics 1,s) (in partic. # of cumulative affiliates # of Cumulative Cumulative number of KEEP participants & affilliates, by year 2.2 Geographic variations in the percent of KEEP participants, by state KEEP N= 55,2. Florida Virginia South Carolina MA/RI/NH/VT North Carolina Indiana Louisiana Oklahoma East Tennessee Eastern/Met-East. MO Hawaii Connecticut Georgia Central New York Arizona Illinois Kentucky Western Pennsylvania Mississippi New Mexico Greater New York Western New York Utah Delaware Valley North Texas Northeast New York Nebraska South/Central Texas Middle Tennessee Maine West Tennessee Minnesota Upstate New York Iowa Ohio Northern California West Texas Alabama Arkansas South Dakota Kansas/Western MO Oregon/Washington Southern California National Capital Area Southeast Texas Michigan CO/ID/MT/WY Wisconsin (5.26) 2.32 to < to < to <.88 below.11 (.3) Percent of participants Percentage of KEEP participants, by affiliate (rank order) KEEP N=55,22. he KEEP program continues to grow, and in 25 recorded 55,22 participants, a nine-fold increase since the program s inception and an increase of 49% from the previous year. Entry criteria into the KEEP program stipulate that individuals have a known history of diabetes or hypertension, or a family history of diabetes, hypertension or kidney disease. Forty-eight affiliates now collect information on participants meeting these conditions. Florida has the highest percentage of KEEP participants, at 7%, followed by Virginia and South Carolina, at 5.2 and 5.1%, respectively. States located in the eastern and southern portions of the country have the highest proportions of KEEP participants, averaging over 5% for states represented by the upper quintile. The KEEP program has yet to make inroads into the northwestern and western regions of the country as evidenced by a particpant average of.3% in these areas. s2 National Kidney Foundation Kidney Early Evaluation Program 26

21 participants participants of Percent 4 2 of Percent 2 1 NE MA ENC WNC SA ESC WSC MTN PAC U.S. Census Divisions (see table below) 2.4 KEEP participants, by U.S. Census Division KEEP N=55,2. Northeast Midwest South West 2.5 KEEP participants, by U.S. Census Region KEEP N=55,2. 1 Age Gender Race/ethnicity participants of Percent KEEP NHANES Male Female White Black Other Hisp non-hisp 2.6 KEEP & NHANES participants, by age, gender, & race/ethnicity KEEP N=55,22, age; 55,143, gender; 54,11, race; 55,22, ethnicity. NHANES N=11,441. Since 2 21, participation has increased across all U.S. Census Divisions, with significant increases of nearly 4% taking place in the Middle Atlantic and Mountain divisions in 25 alone. The majority of KEEP participants reside in the South nearly half live in this census region. The Northeast, Midwest, and West account for 23.3, 16, and 11.4% of patients, respectively. When compared to the NHANES population, KEEP participants tend to be older. The greatest proportion of KEEP participants are age 46 6, while the greatest proportion of NHANES participants are age By gender, the NHANES population is more evenly divided 47.9% males and 52.1% females, compared to 31.7 and 68.3%, respectively, in the KEEP population. Chapter 2 Participant demographics s21

22 t i i t education s p a n c 3 2 GSL SHS HSG SC CG PG c e n t o f p a r 1 P e r t i i t All Educational status in KEEP participants, by year KEEP N=54,545. KEEP NHANES 99-2 s p a n c f p a r e r c e n t o P GSL SHS HSG SC CG PG HSG: 26.5 GSL + SHS: 15.5 HSG: 26. GSL + SHS: SC+ 58. SC+: 51. Northeast Midwest South West 2.8 Educational status of KEEP participants, by U.S. Census Region KEEP N=54, Percent distribution of KEEP & NHANES participants, by educational status KEEP N=54,545; NHANES N=11,394. he educational status of participants in the KEEP program has remained consistent since Nearly 27% have completed high school, more than half have some level of college, and one in five have graduated from college. These rates compare favorably to the 26% high school and 51% college level eduation rates found in individuals participating in the National Health and Examination Survey (NHANES). Educational status differs little within U.S. Census Regions. Approximately 22 28% of KEEP participants have graduated from high school, and 18 22% have a college degree. Fifty-eight percent of KEEP participants report having some level of college or post-graduate education, compared to 51% of NHANES participants. The percentage of study participants age 18 3 having some level of college education is over 15 percent higher in the KEEP population than in the NHANES population. Slightly more white KEEP participants report completing high school compared to blacks; at the college level, however, 62 percent of blacks report some level of college education compared to 6 percent in whites. Half of Hispanic NHANES participants report less than a high school education, compared to one in five KEEP participants. s22 National Kidney Foundation Kidney Early Evaluation Program 26

23 t i i t 75 5 KEEP: Age s t GSL + SHS HSG SC+ Gender p a n i c 25 P e r c e n t o f p a r 75 NHANES Male Female c t i 2.1 Educational status of KEEP & NHANES participants, by age & gender KEEP N=54,545, age; 54,479, gender. NHANES N=11, KEEP 5 s p a n 25 P e r c e n t o f p a r 75 5 NHANES 99-2 GSL + SHS HSG SC+ 25 White Black Other Hisp non-hisp 2.11 Educational status of KEEP & NHANES participants, by race/ethnicity KEEP N=53,456, race; 54,545, ethnicity. NHANES N=11,394. Chapter 2 Participant demographics s23

24 insurance coverage Non- Medicare: 49.5 Medicare: 8.6 Unknown or missing: 26.9 Mcare with other than Mcaid: 11.8 Mcare/Mcaid: 3.2 Percent with insurance Percent distribution of types of insurance coverage in KEEP participants reporting they have insurance KEEP N=55, Insurance coverage in KEEP participants, by year KEEP N=52, insurance with Percent Northeast Midwest South West insurance with Percent Northeast Midwest South West All White Black Other Hisp non-hisp 2.14 Insurance coverage in KEEP participants, by U.S. Census Region & year KEEP N=52, Insurance coverage in KEEP participants, by U.S. Census Region & race/ethnicity KEEP N=51,87, race; 52,912, ethnicity. nly 8.6% of KEEP participants are insured by Medicare; 3.2% have both Medicare and Medicaid coverage, and nearly half have insurance coverage unrelated to Medicare. The KEEP program appears to be reaching more uninsured individuals. In 2 21, for example, 85% of participants reported having medical insurance; in 25, this proportion dropped to 81 percent. The greatest proportion of KEEP participants without insurance occurs in the South census region. A definite gap in insurance coverage exists between Hispanics and non-hispanics. This divergence is most pronounced in the Midwest Census Region, where only 45% of Hispanics are covered compared to an 87% rate for non-hispanics. Wide disparities between the Hispanic and non-hispanic populations are also exhibited in the South and West, at 51.5 and 83.5%, and 59.7 and 83.7%, respectively. Overall, 82% of KEEP and NHANES participants have some form of medical insurance. Coverage increases with age, and is evenly distributed by gender. By race/ethnicity, 89% of KEEP and 86% of white participants, respectively, have medical insurance compared to 57 and 66% in Hispanics. KEEP and NHANES participants with some college education are the most likely to have medical insurance, while those with less than a high school education tend to be under-insured. In Hispanic participants, for example, only 6.5% have completed high school and have medical insurance. s24 National Kidney Foundation Kidney Early Evaluation Program 26

25 insurance with 1 Age KEEP Gender NHANES Percent 25 All Male Female 2.16 Insurance coverage in KEEP & participants, by age & gender KEEP N=52,932, age; 52,866, gender. NHANES N= 11,26. Percent with insurance KEEP NHANES 99-2 Percent of patients KEEP NHANES 99-2 SC+ HSG <HS White Black Other Hisp non-hisp Insurance No insurance Insurance No insurance 2.17 Insurance coverage in KEEP & NHANES participants, by race/ethnicity KEEP N=51,826, race; 52,932, ethnicity. NHANES N= 11, Insurance coverage in KEEP & NHANES participants, by educational status KEEP N= 52,398; NHANES N= 11, KEEP NHANES 99-2 insurance with 75 5 White Black Other Hispanic Percent 25 <HS&Nins <HS&Ins HS+&Nins HS+& Ins <HS &Nins <HS&Ins HS+&Nins HS+&Ins 2.19 Insurance coverage in KEEP & NHANES participants, by educational status & race/ethncity KEEP N=51,381, race; 52,392, ethnicity. NHANES N=11,171. Chapter 2 Participant demographics s25

26 access to medical care 1 Percent with a physician All KEEP participants with a physician, by year KEEP N=53, physician a with Percent 2.21 physician a with Percent Northeast Midwest South West KEEP participants with a physician, by U.S. Census Region KEEP N=53, Northeast Midwest South West All White Black Other Hisp non-hisp KEEP participants with a physician, by race/ethnicity & U.S Census Region KEEP N=52,523, race; 53,653, ethnicity. Eighty-seven percent of KEEP participants report having a physician. Over 9% of KEEP participants residing in the Northeast census region report having a physician, compared to 88, 86, and 85.2%, respectively, in the Midwest, South, and West. The likelihood of having a physician increases with age, is higher in females than in males, and is higher in white participants compared to blacks, people of other races, and Hispanics. Regardless of education level, 94 percent of KEEP participants with insurance report having a physician compared to 52 57% of those without insurance. s26 National Kidney Foundation Kidney Early Evaluation Program 26

27 1 Age Gender Race/ethnicity physician 75 a with 5 Percent 25 All Male Female White Black Other Hisp non-hisp 2.23 KEEP participants with a physician, by age, gender, & race/ethnicity KEEP N=53,673, age; 53,61, gender; 52,542, race; 53,673, Hispanics. 1 Percent with a physician <HS&NIns <HS&Ins HS+&NIns HS+&Ins 2.24 KEEP participants with a physician, by education & insurance status KEEP N=51,571. Chapter 2 Participant demographics s27

28 chapter highlights Figure 2.1 The KEEP program continues to grow, and in 25 recorded 55,22 participants, a nine-fold increase since the program s inception and an increase of 49% from the previous year. Figure 2.3 Florida has the highest percentage of KEEP participants, at 7%, followed by Virginia and South Carolina, at 5.2 and 5.1%, respectively. Figure 2.6 When compared to the NHANES population, KEEP participants tend to be older. The greatest proportion of KEEP participants are age 46 6, compared to NHANES in which the greatest proportion are age By gender, the NHANES population is more evenly divided 47.9% males and 52.1% females, compared to 31.7 and 68.3%, respectively, in the KEEP population. Figure 2.9 Fifty-eight percent of KEEP participants report having some level of college or post-graduate education, compared to 51% of NHANES participants. Figures 2.13 & 2.17 Overall, 82% of KEEP and NHANES participants have some form of medical insurance. Coverage increases with age, and is evenly distributed by gender. By race/ethnicity, 89 and 86% of white participants, respectively, have medical insurance compared to 57 and 66% in Hispanics. Figure 2.2 Eighty-seven percent of KEEP participants report having a physician. Figure 2.7 The educational status of KEEP participants has remained consistent since 2 21; nearly 27% have completed high school, more than half have some level of college, and one in five have graduated from college. U.S. Census Divisions SA: South Atlantic NE: New England WSC: West South Central WNC: West North Central PAC: Pacific ENC: East North Central MTN: Mountain MA: Middle Atlantic ESC: East South Central Educational Status GSL: Grade school or less SHS: Some high school HSG: High school graduate SC: Some college CG: College graduate PG: Post graduate Educational Status (when using NHANES cohort) GSL: Grade school or less + some high school HSG: High school graduate SC+: Some college Education & insurance <HS&NIns: Less than a high school education, & no insurance <HS&Ins: Less than a high school education, & insurance HS+&NIns: High school education or greater, & no insurance HS+&Ins: High school education or greater, & insurance s28 National Kidney Foundation Kidney Early Evaluation Program 26

29 3 H e alth his to r y My mama died from undetected kidney disease in Oct. 22. It was only after 2 years of being treated for high blood pressure, a blood test [was done] to check on her kidneys. She went on dialysis but died a few months later. That s why I got involved and got screened. Thank you for coming and helping us! KEEP Participant: Screening date, December, 25 d i a b e t e s h y p e r t e n s i o n c a r d i o v a s c u l a r d i s e a s e o b e s i t y s m o k i n g e v i d e n c e o f k i d n e y d i s e a s e f a m i l y h i s t o r y & c o m o r b i d i t y i n t e r v e n t i o n Chapter 3 Health history s29

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