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Getting Clinical Data for Research: Columbia’s Clinical Data Warehouse

Getting Clinical Data for Research: Columbia’s Clinical Data Warehouse. Adam Wilcox, PhD Associate Professor of Biomedical Informatics. Secondary Data Analysis of Electronic Clinical Data. Benefits Unobtrusive Fast & inexpensive Easy. Challenges Availability Quality Security. Questions.

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Getting Clinical Data for Research: Columbia’s Clinical Data Warehouse

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  1. Getting Clinical Data for Research:Columbia’s Clinical Data Warehouse Adam Wilcox, PhDAssociate Professor of Biomedical Informatics

  2. Secondary Data Analysis of Electronic Clinical Data Benefits • Unobtrusive • Fast & inexpensive • Easy Challenges • Availability • Quality • Security

  3. Questions • What data are available? • How good are the data? • How do I get data? • What’s the worst that can happen?

  4. What’s the worst that can happen?

  5. HIPAA PHI • Names • MRNs • Addresses • Telephone and fax #s • SSNs • Email addresses • Dates • Certificate numbers • Employers names/addresses • Geographic subdivisions smaller than state, except initial 3 digits of zip code • Account #s • URLs • IP addresses • Biometric identifiers • Full face photographs • Any other characteristics that may be used individually or in combination to identify the individual

  6. HITECH Penalties • Notification of Breach • If more than 500 patients, HHS also notified • Media • Civil penalties • Up to $250,000 • Repeat violations up to $1.5M

  7. What’s the worst that can happen?

  8. CUMC/NYP Clinical Data Warehouse History • 1994: Created, sponsored by Columbia University Department of Medical Informatics and Office of Clinical Trials • Populated with data from existing clinical data repository • Supporting clinical research • 1998: Columbia + Cornell = NewYork Presbyterian Hospital • Warehouse funded by NYPH • Goal to incorporate and provide data across whole system • 2004: Formal analysis of CDW user needs by Clinical Quality and Information Technology Committee (CQIT) • Creation of Data Warehousing Subgroup • Need to bring together disparate clinical data sources • Need to manage user requests for data

  9. What data are available? • Patient demographics • Visit history • Diagnoses • Procedures • Vital signs • Medications • Flowsheet elements, structured notes • (Notes)

  10. Patients and Visits

  11. Patient Ages (visits in last year)

  12. Race/Ethnicity

  13. Sex

  14. Visit Types (last 5 years)

  15. Other Data (in last year)

  16. How do I get data? 1: Gain access to data (to be updated in coming weeks) 2: Explore data using tools & select variables 3: Request & refine data from Clinical Data Warehouse (CDW) 4: Data management & analysis I have a WebCIS login Submit HIPAA D preparatory to research forms What level of identifying patient information are you requesting? Receive data set Y Top 50 Variables List & Meaningful Use variables N De-identified Limited*** Identifiable • Import & manage data for analysis using: • SAS • Stata • REDCap • AMALGA • Other Contact Adam Wilcox Receive HIPAA approval • De-identified databases: • RedEx • I2B2* Covered by HIPAA G§ Fill out HIPAA B Other** Receive HIPAA approval Loop back to DISCOVERY for approval to publish data and findings Submit IRB & receive approval Pin down key variables to submit via DISCOVERY Fill out DISCOVERY form to request data Share results with CER Studio regarding findings & DISCOVERY process Work with programmer to refine data

  17. DISCOVERY

  18. WICER Community Survey 8,000+ surveys

  19. WICER Research Data Warehouse

  20. Research Data Explorer (RedX)

  21. I2b2 Workbench

  22. WICER CER Studio • Identify priority disparity areas for CER • Integrate statistical expertise via preliminary studies • Validation analyses on cost and service utilization • Identify high-risk physical & mental comorbidities • Integration of data • Collection and storage of patient-reported data • Identify individuals based upon eligibility criteria • EHR plug-in • Informatics tools to support data retrieval • Intervention delivery • De-identify and link datasets

  23. Questions • What data are available? • How good are the data? • How do I get data? • What’s the worst that can happen?

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