Surveillance of Kidney Disease Principles and Practice Rajiv

Surveillance of Kidney Disease Principles and Practice Rajiv

Surveillance of Kidney Disease Principles and Practice Rajiv Saran, MBBS, MD, MRCP, MS Florence E. Bingham Professor of Nephrology Professor of Medicine and Epidemiology Director, USRDS Coordinating Center University of Michigan Ann Arbor, Michigan Public Health Surveillance Systems: (Significance / Purpose) Surveillance is fundamental to the practice of modern public health It is vitally important to have data and information required to characterize the epidemiology of the

disease/condition Guide public health intervention for population health improvement Advocacy, decision making, program planning and implementation 2 Public Health Surveillance Definition Ongoing, systematic, collection, analysis and interpretation of health data essential to the planning, implementation and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to know and ACT upon that information LINK TO PUBLIC HEALTH PRACTICE

COLLECT ANALYZE DISSEMINATE INTERPRET Thacker and Berkelman, 1988 Types of Surveillance Passive Utilize already collected data typically for other purposes (e.g., health care claims, death and birth registries, census data)

Passively accumulating data in health systems (EMR based) Active Community-wide screening efforts (e.g., BRFSS, NHANES, WHO STEPS Surveys, NKFs - KEEP) Ongoing, population-based cohort studies (Framingham, DOPPS) 4 Desirable Attributes of a Surveillance System

Simple Quality Timely Representative Well-defined denominator Sensitive Specific Flexible Stable & Sustainable

Impactful 5 Key Examples of Kidney Disease Specific Surveillance Systems [in the US] US Renal Data System (USRDS) CDC CKD Surveillance System VA Renal Information System (VA REINS) 6 Comprehensive Surveillance & Epidemiology of Kidney Disease

in the United States USRDS: Major Objectives High Quality Epidemiology & Surveillance of Kidney Disease for the United States The finest kidney disease data system in the world! Dr. Paul Eggers, NIDDK A go to resource for data and trends related to kidney disease for the US Conduct and Stimulate Research, Inform Public Health Priorities and Policy: Conduct and Facilitate High Impact Research that impacts policy and practice USRDS Annual Data Report 2017

www.usrds.org 9 ESRD Database at the University of Michigan KECC Development of the ESRD Database began in 1988, with the first USRDS contract (Dr. Philip Held, PhD, Director) Covers a broad spectrum of patient information Over 3 million patients Over a trillion events e.g., dialysis sessions, transplants, deaths, hospitalizations Contains information on ~ 7,000 facilities in the United States

10 Sources of Medicare ESRD Database CMS ESRD Sources CROWNWeb Medicare Claims Part A Part B Part D Enrollment Database Dialysis Facility Data ESRD Database

CMS/OPTN Data Source Transplant Data 11 Trends in the Annual Number of ESRD Incident Cases, by Modality, in the U.S. population, 1980-2015 12 Map of the Adjusted Incidence Rate of ESRD, by Health Service Area, in the U.S. Population 2011-2015

Data Source: Special analyses, USRDS ESRD Database. Standardized for age, sex, and race. The standard population was the U.S. population in 2011. Values for cells with 10 or fewer patients are suppressed. Abbreviation: ESRD, end-stage renal disease. 13 Lifetime Risk of ESRD in the United States (2013) Cumulative incidence (%) of ESRD from birth to age 100+, by race/ethnicity (a) Males (b) Females Albertus, P. et al. Am J Kid Dis 2016

Albertus, P. et al. Am J Kid Dis 2016 14 In cid en ce R ate R atio Day of the Week and Emergency Room Visits by Hemodialysis Schedule Mon/Wed/Fri Tue/Thu/Sat 0.66 1.50

1.00 Ref. Sun Mon Tue Wed Thurs Fri

Sat Zhang S, Morgenstern H, He K, Albertus P, Nallamothu B, Saran R. Submitted 15 www.cdc.gov/ckd/surveillance BURDEN OF CKD RISK FACTORS AWARENESS

of CKD MAJOR TOPICS PROCESSES OF CARE HEALTH OUTCOMES HEALTH SYSTEM CAPACITY Saran et al. CJASN 2010

18 Data Sources CKD in the US National Surveys NHANES BRFSS Health Care Administrative Data

CMS, VAHS Managed Care Data Special Populations Children Elderly Nat American Uninsured Medicaid National Registries SRTR

USRDS (ESRD) Large Cohort Studies CRIC, CKID ARIC Saran et al. CJASN 2010 19 US State-Level Awareness of CKD Dharmarajan S, et al. Am J Prev Med 2017

Provider Awareness of CKD has been Low but Increasing eGFR defined by MDRD, using outpatient creatinine values Provider documentation = ICD9 codes 2005-2012 26.9% 41.4% CKD Surveillance System- United States website: http://nccd.cdc.gov/CKD The Veterans Affairs Renal Information System (VA-REINS)

An Introduction / Overview 22 Background High prevalence and high cost of kidney disease amongst US veterans A need was recognized to develop a comprehensive kidney disease data system that could potentially serve both operational and research needs for the Department of Veterans Affairs The VA REnal INformation System (VA-REINS) was conceptualized and developed by a team at the University of Michigan

Under a contract with the Department of Veterans Affairs Office of Innovation In collaboration with a VA Advisory Group 23 VA-REINS Conceptual Framework: Data Sources 24 Prevalence of CKD Among US Veterans Restrictive (narrow) definition of CKD Total VA Users (denominator) With persistent* eGFR < 60 ml/min/1.73 m2 With AER/ACR/PCR/PER Moderate or Severe

With ICD-9 CKD Diagnosis With any of the above Liberal (broad) definition of CKD Total VA Users (denominator) With any eGFR < 60 ml/min/1.73 m2 With AER/ACR/PCR/PER/Dipstick Moderate or Severe With ICD-9 CKD Diagnosis With any of the above % No. VA Users 6,932,278 713,068 555,778

220,666 100 10.2 8.0 3.2 1,140,382 16.4 No. VA Users 6,932,278 1,869,755 1,342,435

220,666 % 100 27.0 19.4 3.2 2,516,475 36.3 *persistent: two most recent consecutive eGFR both < 60 ml/min/1.73m2 and at least 90 days apart

25 Aggregate VA Spending on VA Users with CKD FY 2006 FY 2014 Aggregate spending is defined as total spending both internal and external to the VA and allocated to the care received by VA users identified as having CKD. Total spending may not be specific to, or attributable, to CKD per se. 26 VA-REINS: Potential Functions 1 Population Health Management for CKD Identify individuals at risk for CKD or progression Reporting and Evaluative Function Quality Measures for CKD

Point-of-care (POC) patient management POC Dashboards Decision Support Link with PCMH / Telehealth / Patient portal 27 VA-REINS: Potential Functions 2 Research Function : In the future, the VA-REINS could also be used to provide datasets for analysis to researchers upon request. Disease Information System: The principles utilized in the development of VAREINS have the potential to be leveraged for other conditions such as diabetes, hypertension,

cardiovascular disease, mental health, etc. 28 Public Health Surveillance Definition Ongoing, systematic, collection, analysis and interpretation of health data essential to the planning, implementation and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to know and ACT upon that information LINK TO PUBLIC HEALTH PRACTICE COLLECT

ANALYZE DISSEMINATE INTERPRET Thacker and Berkelman, 1988 Analogy to a Learning Health System Courtesy Charles Friedman, PhD Courtesy Charles Friedman, PhD The LHS Learns and Improves through

Virtuous, Rapid Cycles of Study and Change Interpret Results Analyze Data Tailored Messages Assemble Data Take Action Record Actions Courtesy Charles Friedman, PhD The Big Idea: A Health System or Community Can Learn & Improve

Every participating patients characteristics and experience are available to learn from Best practice knowledge is immediately available to support decisions Improvement is continuous through ongoing study An infrastructure enables this to happen routinely and with economy of scale All of this is part of the culture Courtesy Charles Friedman, PhD 32 Thank You The USRDS Team ! 33

Thank You CDC-CKD Surveillance Team! Thank You: VAREINS Team! 35 CKD Data Sources 1 NHANES (National Health and Nutrition Examination Survey) Conducted by the CDC and the National Center for Health Statistics Random stratified sample of the US population Frequency: Biannual (every 2 years)

BRFSS: Behavior Risk Factor Surveillance System State-level phone survey conducted by state health departments with CDC oversight 36 CKD Data Sources 2 Medicare 5% sample for those covered (majority are >65years old) 1.1 million each year National Veteran Health System Data 8 million veterans actively seeking health care in the VA Employer Based Insurance: Data on younger, employed

population and their dependents: from a national health insurance company, has data on all age groups Clinformatics Data Mart 37 vol 2 Figure 1.1 Trends in the (a) unadjusted and standardized incidence rates of ESRD, and (b) the annual percentage change in the standardized incidence rate of ESRD in the U.S. population, 1980-2015 (a) Incidence rate per million/year Data Source: Reference Table A.2(2) and special analyses, USRDS ESRD Database. Standardized for age, sex, and race. The standard population was the U.S. population in 2011. Abbreviation: ESRD, end-stage renal disease. 38

State-level SMR by % with >12months of Pre-ESRD Care Gillespie BW et al. Clin Kidney J. 2015;8(6):772-780 Awareness of CKD: Key to Improving Health Outcomes Provider Awareness Guideline-Based Care Health Outcomes

Patient Awareness Behavior Change Variation in Self-Reported CKD by State Estimated prevalence of self-reported kidney disease by state. BRFSS participants ages 18 and older, 2014 (n=464,617) https://www.usrds.org/2016 Objectives To develop a high quality data system (with individual patientlevel data) within the framework of VAs existing IT

infrastructure, that is capable of facilitating: Surveillance of all aspects of kidney disease (at national, regional, facility and provider level) Population health management Continuous Quality Improvement Facilitate direct patient care Learning health system culture 42 Cost of VA Care for CKD Total VHA spending for VA users with CKD has increased by 63% (26% increase when adjusted for inflation) 12 billion in FY 2006

19 billion in FY 2014 Over 75% of spending has been for stage 3A or 3B CKD Majority of CKD users have stage 3A or 3B CKD Cost per patient is highest for CKD Stage 5 43 Estimating Prevalence of CKD using Health System Data: Issues Data collected for clinical/administrative purposes Testing for creatinine and urine protein is not universal, and reflects clinical practice

Choosing the appropriate denominator critical Applying KDIGO definition has potential to under estimate prevalence 44 Prevalence of CKD Among US Veterans As part of the development of a VA Renal Information System (VA-REINS) for the US Department of Veterans Affairs, we sought to: Explore operational definitions of CKD to guide population health management of kidney disease for veterans utilizing the VA Healthcare System

Estimate the prevalence of CKD among VA users during FY 2006-2014 45 Average VA Costs ($) per Patient per Year, by CKD Stage, FY 2006-2014 46 VA REINS Current Status and Future Potential 47

VA-REINS: Current Status 1 A (Foundational) VA Renal Information System (VA-REINS) dedicated to coverage of all aspects of kidney disease, has been created for the National VA Health System It builds upon VAs existing IT infrastructure in VAs corporate data warehouse (CDW) linked with data sources extrinsic to the VA, primarily derived from Medicare and National ESRD Databases 48 VA-REINS: Current Status 2 CKD, AKI, ESRD Surveillance: VA-REINS can allow accurate and timely tracking of the

burden of kidney disease (AKI, CKD, ESRD, individuals with risk factors for kidney disease) and kidney disease-related outcomes Cost Tracking: VA-REINS can be used to track the cost of kidney disease management (both in the VA health system and care that VA pays for to external entities so called fee-basis costs) to help inform cost-efficient care for US veterans while improving quality of care 49 Public Health Surveillance Ongoing, systematic, collection, analysis and interpretation of health data

essential to the planning, implementation and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to know LINK TO PUBLIC HEALTH PRACTICE COLLECT ANALYZE DISSEMINATE INTERPRET Thacker and Berkelman, 1988

Thacker and Berkelman, 1988 The LHS Connects Discovery to Practice Better Health = D2K + K2P + P2D Courtesy Charles Friedman, PhD Better Health Requires This Courtesy Charles Friedman, PhD 52 Not This

Journals Courtesy Charles Friedman, PhD 53 Managing Knowledge: One of the Biggest Challenges Knowledge is the result, that an informed community considers significant, of an analytic and/or deliberative process

K Knowledge connects D2K and K2P To enable this connection, knowledge must be represented in a persistent form: - A prediction equation - A practice guideline Courtesy Charles Friedman, PhD 54 55

Major Tasks for the USRDS 1 Kidney Disease Epidemiology: Annual Data Report All epidemiologic aspects of kidney disease in the United States Maintain and update the USRDS Database(s) Data Analysis + Production Website maintenance and updates 56 Major Tasks for the USRDS 2 Research Conduct research at the coordinating center

Assist external researchers Standard Analysis File (SAF) requests Data merge requests Government requests for data or information Simple to complicated Annual presence at major national and international meetings (e.g., ASN, NKF, EDTA etc.) 57 CKD Surveillance Dissemination Routes Website (Audience: Public Health Officials,

Science & Healthcare, Media) http://nccd.cdc.gov/CKD/ Are you Aware Emails (Audience: Public Health Officials, Science & Healthcare) Abstracts & Symposiums at professional meetings ASN, NKF, APHA, SGIM, ISN (Audience: Science & Healthcare) (Audience: Public Health) Fact Sheet (Audience: Policy, Media, Public)

Publications and Editorials in peer-reviewed journals (Audience: Science & Healthcare) VA-REINS Conceptual Framework 1 Comprehensive in scope Cover the entire spectrum of kidney disease (risk factors for disease, CKD, ESRD, AKI) Track data, trends and outcomes over time Establish a denominator population of VA users Calculation of incidence / prevalence Comparisons and integration with other chronic conditions

Leverage both VA and non-VA (e.g., Medicare) data Veterans do not use the VA exclusively 60 VA-REINS Conceptual Framework 2 The Veterans Health Administration (VA) maintains several data sources for documenting patient care within and paid-for by the VA (fee-basis) The primary data sources are contained within the VA

Corporate Data Warehouse (CDW), VA electronic medical record data VA Regional Data VA Managerial Cost Accounting (MCA) system VHA National Patient Care Database (NPCD) VAs personal health record system 61

VA-REINS Conceptual Framework 3 Other VA data sources include VA Vital Status files, which provide summarized patient demographics from several federal agencies (VA, Social Security Administration, and the Center for Medicare and Medicaid Services) VA-REINS works with the CDW database and other relevant input data and, through further processing, provided a more organized platform from which to conduct further analysis and summaries of patients demonstrating characteristics relevant to kidney disease.

62 VA-REINS Conceptual Framework 5 Primary Domains/Tables VA REINS Primary Domains/Tables Dialysis Procedures Master Patient List ESRD Diagnosis Transplant Procedures VA User by Fiscal Year

Transplant Diagnosis Vascular Access Comorbidities CKD/AKI Indicators Hospitalization /ED Lab Data 63 VA-REINS Standard Lab Classification

In the CDW, there is one identifier for a given lab within a given station Inconsistencies in the lab test names make comparison and verification of labs difficult LOINC (Logical Observation Identifiers Names and Codes) coding, when available on a lab test result, can inform this process allowing for standardization of some labs across the CDW LOINCs have been adopted in the VA system since 2008 64 VA-REINS Standard Lab Classification Not all lab result records in the CDW contain a

direct match to a LOINC code However, we can identify what test each identifier represents from the records for that Serial Identifier (SID) that do contain LOINC codes As accurate LOINC association improves, lab selection results will also improve 65 66 Definition of VA-User Defines criteria to establish the source population in each fiscal year, i.e., the denominator for conducting most analyses

Federal Fiscal Year = Oct 1 prior year through Sept 30 current year Requires at least one visit in the VA within the current or prior two fiscal years and still living at the start of the current fiscal year For example, VA users in FY2014 would include veterans alive on 10/1/14, who made one visit to a VA facility in FY2012, FY2013, or FY2014 67 VA Users 68

Selected Results Operational Definition and Prevalence of CKD among VA Users Cost of Care for Chronic Kidney Disease (CKD) for VA users 69 ASN 2016 VA-REINS Posters Poster # Title Day Authors

#4016 Timing of Arteriovenous Fistula Creation Prior to Hemodialysis Start in TH-PO1071 the Veterans Affairs Healthcare System Rajiv Saran*, Anca Tilea, Sai Hurrish Dharmarajan, John Stephen, Aaron Pearson, Richard Eikstadt, Diane Steffick, Brenda W. Gillespie, Hal Morgenstern, Eric W. Young, Edward D. Siew, Michael J. Fischer, Karen Sovern, Daniel F. Balkovetz, Susan T. Crowley and Vahakn B. Shahinian #3605

Identification of Chronic Kidney Disease in the Veterans Affairs Healthcare System FR-PO715 Rajiv Saran*, Anca Tilea, Vahakn Shahinian, Aaron Pearson, Jennifer L. Bragg-Gresham, Hal Morgenstern, Brenda W. Gillespie, Alan B. Leichtman, Ann M. O'Hare, John R. Hotchkiss, Daniel, F. Balkovetz and Susan T. Crowley #4064 Age-Dependent Thresholds of Kidney Function and Progression to End Stage FR-PO724

Renal Disease in the Veterans Affairs Healthcare System Jennifer L. Bragg-Gresham*, Anca Tilea, Hal Morgenstern, Vahakn B. Shahinian, Ann M. O'Hare, Daniel F. Balkovetz, Linda F. Fried, Susan T. Crowley and Rajiv Saran. #3969 Costs of Chronic Kidney Disease During Transitions Between Stages of CKD SA-PO912 Among US Veterans David Hutton, Debabrata Ray, Hal Morgenstern, Anca Tilea, Diane

Steffick, Aaron Pearson, Michael J. Fischer, Denise M. Hynes, Chuanfen Liu, Edward D. Siew, Daniel F. Balkovetz, Susan T. Crowley and Rajiv Saran. INFO23 Establishing a National Population Health Management Solution for Kidney Disease: The Veterans Health Administration Renal Information System (VA-REINS) R Saran; V Shahinian; A Pearson; A Tilea; D Steffick; J BraggGresham; M Heung; H Morgenstern; D Hutton; A Milovanovic; B Gillespie; A Leichtman; E Young; A OHare; M Fisher; J Hotchkiss; D Hynes; L Fried; E Siew; D Balkovetz; K Sovern; Liu C; S Crowley

INFO23 70 Kidney Disease Registry VA Representatives VA Steering Committee VA Advisory Committee & Advisors Anthony Ashei Susan Crowley, MD Daniel Balkovetz, MD, PhD

Michael Cagan VA New England Birmingham VA Medical Center VA Medicare and Medicaid Analysis Center Michael Fischer, MD, MSPH Ryan Ferguson, ScD, MPH Joe Francis, MD, MPH

Linda Fried, MD, MPH Rudolph Rodriguez, MD Gail Graham VA Pittsburgh Healthcare System Seattle VA Medical Center ADUSH for Informatics and Analytics Denise Hynes, PhD, MPH

John Hotchkiss, MD William Gunnar, MD Edward Hines Jr. VA Hospital Pittsburgh VAMC National Surgery Office Ann OHare, MD Chuan-Fen Liu, PhD, MPH Farah Lowe-Bey

Edward Siew, MD Sandra Cupples, PhD, RN Jack H. Varga, MD, MHSA, Jesse Brown VA Medical Center Seattle VA Medical Center Tennessee Valley VA Healthcare System Eric Hickam Innovation Coordinator, COTR

MAVERIC VA Puget Sound Health Care System National Surgery Office Stanlie M. Daniels, RN IPEC Director Karen Sovern, MSN, RN Ann Arbor VA Investigator IPEC

Eric Young, MD, MS Shawn Loftus, IPEC Chief of Staff Washington OIT Clinical Analytics and Reporting VHA-OHI-Health Systems-RAEM Physician Informaticist, Office of Informatics and Analytics Timothy Trautman

VINCI/Salt Lake OI&T Jemell Brown IT Project Manager, Navy Frankie Rios OI&T, Product Development 71 Data Security Servers located at a secure offsite facility VPN into servers

Data with personally identifiable information can only be accessed by a small group of programmers All shared data are de-identified Strict quality control in this regard Periodic security training and stringent security reviews both internal and external 72

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