Session Chair: Marcia Stefanick, PhD
description
Transcript of Session Chair: Marcia Stefanick, PhD
Cardiovascular Health Services Research: Maximizing the Value of CMS Linkage to the Unique Database of the WHI
Cohort of Postmenopausal WomenWomen’s Health Initiative Scientific Symposium May 3-4 2012
Cardiovascular SIG and Health Services Research SIG
Session Chair: Marcia Stefanick, PhDMedicare Linkage to WHI: Progress Since May 2011 Dale Burwen, MD, MPH
CHD Outcomes Among Medicare - Eligible Women in WHI Mark Hlatky,
MD
Validation of Acute Stroke in Medicare Data against WHI Kamakshi Lakshminarayan, MD, PhD - presented by Dale Burwen, MD, MPH
Atrial Fibrillation in the WHI Hormone Trials and Observational Study: Findings with and without inclusion of CMS data Marco Perez, MD
CV Analyses Underway Using Medicare Data Karen Margolis, MD,
MPH
Panel Discussion: Future HSR-CV research Mark Hlatky, MD, Beth Virnig, PhD
Medicare Linkage to WHI:Progress Since May 2011
Dale Burwen, MD, MPHMedical Officer
Women’s Health Initiative BranchPopulation and Prevention Sciences Program
Division of Cardiovascular SciencesNational Heart, Lung, and Blood Institute
WHI Investigator MeetingMay 4, 2012
Why Medicare data are important to WHI WHI CMS implementation working group Validation strategy Progress report Medicare Data Update Foundation for future research
Outline
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During the 2010-2015 extension, medical record sub-cohort is limited to 24% of participants
For 76% of participants, only self-report (of hospitalization or particular outcomes) will be available from WHI Reliant on participant’s understanding of diagnosis
and memory Corroboration using standardized observable data is
desirable Medicare data may be a cost-effective approach
to corroborate outcomes
Why Medicare Data are Important to WHI
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Virtually all current participants are >65 years old, and thus eligible for Medicare Among those who were age eligible at baseline,
2/3 were enrolled in fee-for-service Medicare Claims data are available for those enrolled in fee-
for-service Medicare Key outcomes increase substantially with age,
outpacing resources for medical record review Medicare data can potentially provide outcome
data on a large proportion of WHI participants
Why Medicare Data are Important to WHI (cont.)
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Provide rich information about coded diagnoses and procedures in all settings, e.g., Inpatient, institutional outpatient, physicians’ offices, home health,
hospice Provide outcomes on an expanded sample Include follow-up on former participants Record all episodes of care, including subsequent events
that may not be ascertained in WHI Provide healthcare utilization and cost data, which can
facilitate health services research Link with WHI data for rich detail regarding participant
characteristics
Advantages of Medicare Data
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Garnet Anderson Mary Pettinger Ross Prentice Karen Margolis Beth Virnig Marian Limacher Dale Burwen
WHI CMS Implementation Working Group
To ensure program goals are met To help optimize use of CMS data in WHI To facilitate efficiency by addressing cross-
cutting issues To bring together expertise in both CMS and
WHI data To contribute methodologic expertise
WHI CMS Implementation Working Group
Working Groups
WHI CMS Implementation
Group
CHD
Stroke
PAD
HF
VTE
HSR SIGCVD-DM Subgroup
Validation effort initiated to assess whether Medicare data can be used for cardiovascular outcomes in WHI
Products envisioned for each outcome: Useful coding algorithm Publication of algorithm performance
- e.g., sensitivity, specificity, PPV, NPV, kappa- May be a whole paper, or a paragraph or appendix
in a paper focusing on a broader analysis
Validation Strategy
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Validation is a highly important goal, but it is an intermediate goal
Ultimate goal is to demonstrate usefulness of Medicare data in WHI for Outcomes analyses Health services research
Some of the papers will combine validation and application in additional analyses
Working groups may serve as focal points for stimulating additional paper proposals using the Medicare outcomes
Validation Strategy (cont.)
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Topic* Status of Validation Effort1 Coronary disease (e.g.,
myocardial infarction, revascularization)
Paper proposal approved. Focuses on comparing hormone trial results using Medicare versus WHI outcomes.
2 Stroke Paper proposal approved. Focuses on validation using neurologist adjudicated events.
3 Peripheral artery disease
Paper proposal approved. One paper on validation; another on hormone therapy analysis.
4 Venous thromboembolism
Working group drafting paper proposal that will include validation and broader analyses.
5 Heart failure Working group brainstorming about validation and broader analyses.
Progress Report
* Potential future topics: Atrial fibrillation, Valvular disease, Dementia
1991-2007 data previously linked by CCC e.g., MedPAR, Carrier, Outpatient, Home Health, Hospice
2008-2010 received by CCC in February 2012 2011 onwards to be requested annually Part D prescription drug data request 2006-2010
Submitted April 2012 for review before forwarding to CMS Virtual Data Enclave
Potentially will allow access by field investigators Description submitted as part of data use agreement (DUA)
Await CMS Privacy Board approval of DUA WHI policies and processes for access are under
development
Medicare Data Update
Medicare data are research identifiable files CMS Data Use Agreement (DUA)
Describes purposes of use Requires appropriate administrative, technical and physical
safeguards Indicates penalties for unauthorized disclosure Requires destruction of data at end
Field sites using proposed data enclave need to be aware of security issues
WHI should be proactive in implementing best practices
Data Security
Foundation for Future Research
Toolbox being developed to effectively use Medicare data within the WHI program
Outcomes AnalysesHealth Services Research
ValidationMethods Development
Data EnclaveMedicare Linkage
Outcomes AnalysesHealth Services Research
ValidationMethods Development
Data EnclaveMedicare Linkage