VA Resources for Dermatology Research


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VA Resources for Dermatology Research

  1. 1. VA Resources for DermatologyVA Resources for Dermatology ResearchResearch Robert A Lew, PhDRobert A Lew, PhD Associate Professor of BiostatisticsAssociate Professor of Biostatistics Boston University School of Public HealthBoston University School of Public Health Director of Analysis of Clinical Trials at theDirector of Analysis of Clinical Trials at the Massachusetts Veterans EpidemiologyMassachusetts Veterans Epidemiology Research and Information Center (MAVERIC)Research and Information Center (MAVERIC)
  2. 2. Veterans Health AdministrationVeterans Health Administration
  3. 3. Department of Veterans Affairs Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) Lou Fiore, MD Michael Gaziano, MD Mary Brophy, MD VA Study Design and DatabaseVA Study Design and Database ResourcesResources
  4. 4. MAVERICMAVERIC • • $8,000,000 in direct funds per year.$8,000,000 in direct funds per year. • Four components: ERIC, CSPCC,Four components: ERIC, CSPCC, Core Lab, Infromatics CoreCore Lab, Infromatics Core
  5. 5. MAVERICMAVERIC ERIC - Epidemiology Research InformationERIC - Epidemiology Research Information Center (M. Gaziano)Center (M. Gaziano) CSP CC - Trial Coordinating Center (L. Fiore)CSP CC - Trial Coordinating Center (L. Fiore) VA Core Laboratory - Blood and tissueVA Core Laboratory - Blood and tissue collection and storage (M. Brophy)collection and storage (M. Brophy)
  6. 6. VA Boston JP CampusVA Boston JP Campus
  7. 7. VA National Centers for ResearchVA National Centers for Research  12-million electronic patients records and12-million electronic patients records and supporting electronic medical documentssupporting electronic medical documents  Average of 5 years follow-upAverage of 5 years follow-up  7 VA research centers affiliated with major7 VA research centers affiliated with major universitiesuniversities  Large budgets devoted to veterans’ careLarge budgets devoted to veterans’ care  Impressive security and bureaucracyImpressive security and bureaucracy
  8. 8.  Centers conducting many large clinical trialsCenters conducting many large clinical trials MAVERIC - BostonMAVERIC - Boston West Haven - New HavenWest Haven - New Haven Palo Alto – StanfordPalo Alto – Stanford  Centers with epidemiology research programsCenters with epidemiology research programs MAVERIC BostonMAVERIC Boston West HavenWest Haven DurhamDurham SeattleSeattle  Centers conducting a few large clinical trials and variety ofCenters conducting a few large clinical trials and variety of other large clinical studiesother large clinical studies Hines – ChicagoHines – Chicago Perry Point - BaltimorePerry Point - Baltimore
  9. 9. Statins and MelanomaStatins and Melanoma ThicknessThickness Marie-France Demierre, MD. BU DermatologyMarie-France Demierre, MD. BU Dermatology Wildon Farwell, MD. VA MAVERICWildon Farwell, MD. VA MAVERIC Do statin users have thinner melanomaDo statin users have thinner melanoma lesions?lesions? Find VA cases of melanoma, assess prior statinFind VA cases of melanoma, assess prior statin use, record Breslow thickness.use, record Breslow thickness. Found ~1000 melanoma diagnosis, expect ~200Found ~1000 melanoma diagnosis, expect ~200 path confirmed. Over 90% have thickness.path confirmed. Over 90% have thickness.
  10. 10. Set up and conduct a studySet up and conduct a study  Write 4 page proposal: Background, Design,Write 4 page proposal: Background, Design, Statistical methods, Limitations.Statistical methods, Limitations.  Review by VA physicians, epidemiologists,Review by VA physicians, epidemiologists, statisticians. Revise design and resubmit.statisticians. Revise design and resubmit.  Specify data retrieval, abstraction if needed,Specify data retrieval, abstraction if needed, database structure, detailed analysis plan.database structure, detailed analysis plan.  Progress reports andProgress reports and technical support.technical support.  Register final analytic dataset andRegister final analytic dataset and definitive analyses.definitive analyses.
  11. 11. Set up a randomized clinicalSet up a randomized clinical trialtrial Submit 10-20 page ‘letter of intent’ study proposal.Submit 10-20 page ‘letter of intent’ study proposal. National VA reviews and selects a few proposals.National VA reviews and selects a few proposals. National VA assigns proposal to a VA center.National VA assigns proposal to a VA center. The VA center works with proposer for 6-12The VA center works with proposer for 6-12 months to write a full proposal.months to write a full proposal. National VA reviews a set of full proposals andNational VA reviews a set of full proposals and funds a few.funds a few. Typical multicenter study has 500-2000 subjectsTypical multicenter study has 500-2000 subjects with a multimillion dollar budget.with a multimillion dollar budget.
  12. 12. Dr. Weinstock’s StudiesDr. Weinstock’s Studies  Topical tretrinoin chemoprevention ofTopical tretrinoin chemoprevention of keratinocyte cancer. Completed.keratinocyte cancer. Completed. VA Perry PointVA Perry Point  Chemoprevention of keratinocyte cancerChemoprevention of keratinocyte cancer with field treatment. Awaiting finalwith field treatment. Awaiting final approval.approval. VA MAVERIC BostonVA MAVERIC Boston
  13. 13. VA SupportVA Support : Pro and Con: Pro and Con  Electronic data captureElectronic data capture  Extensive database structure and servicesExtensive database structure and services  Continuous expert reviewContinuous expert review  Management of remote medical sitesManagement of remote medical sites  Statistical supportStatistical support  Drawbacks - bureaucracy, security, andDrawbacks - bureaucracy, security, and competition for resources.competition for resources.
  14. 14. VA National Data ElementsVA National Data Elements  National Patient Care Database (NPCD)National Patient Care Database (NPCD) – 1997-20081997-2008 – 12 million enrollees, on average 5 years of follow-up12 million enrollees, on average 5 years of follow-up – All Inpatient and Outpatient DataAll Inpatient and Outpatient Data – DSS Data: Pharmacy inpatient and outpatientDSS Data: Pharmacy inpatient and outpatient – DSS Data: National Lab FilesDSS Data: National Lab Files  Medicare DataMedicare Data  VISNVISN – Regional data feedsRegional data feeds – Patient ChartsPatient Charts – Ancillary information (pathology pharmacy)Ancillary information (pathology pharmacy)
  15. 15. VA National DatabasesVA National Databases National Patient Care DatabaseNational Patient Care Database  Inpatient and outpatient encountersInpatient and outpatient encounters  ICD-9 diagnosis and procedure data, CPT procedureICD-9 diagnosis and procedure data, CPT procedure datadata Beneficiary Information and RecordsBeneficiary Information and Records Locator System (BIRLS) -DeathsLocator System (BIRLS) -Deaths  Augment with Social Security Administration DataAugment with Social Security Administration Data Decision Support Systems DataDecision Support Systems Data  CostCost  PharmacyPharmacy  Selected Laboratory dataSelected Laboratory data – Creatinine, Total Cholesterol, HDL, LDL, Triglycerides,Creatinine, Total Cholesterol, HDL, LDL, Triglycerides, HbHb
  16. 16. National Patient Care DatabaseNational Patient Care Database All inpatient and outpatient encountersAll inpatient and outpatient encounters  ICD-9 diagnosis code dataICD-9 diagnosis code data  CPT procedure data for outpatientsCPT procedure data for outpatients  ICD-9 Procedure codes for inpatientsICD-9 Procedure codes for inpatients  FY 1997-2005, first 2 quarters FY 2006FY 1997-2005, first 2 quarters FY 2006  Mortality files (BIRLS and SSA_DMF)Mortality files (BIRLS and SSA_DMF)
  17. 17. National Data: Pharmacy DataNational Data: Pharmacy Data  Pharmacy DataPharmacy Data  FY 2002 - presentFY 2002 - present  Separated Inpatient and OutpatientSeparated Inpatient and Outpatient  Elements include:Elements include: – prescriptionprescription – unit doseunit dose – IV detailsIV details
  18. 18. National Data: Laboratory DataNational Data: Laboratory Data Lab DataLab Data – Two filesTwo files – Lab Results, Lab Utilization andLab Results, Lab Utilization and CostsCosts – Lab results (FY 2000)Lab results (FY 2000) – Lab Costs (FY 2002)Lab Costs (FY 2002) – Separated Inpatient and outpatientSeparated Inpatient and outpatient files by visnfiles by visn
  19. 19. National Data: Radiology DataNational Data: Radiology Data Two filesTwo files Radiology UtilizationRadiology Utilization and Costs (but no images)and Costs (but no images) –Lab results (FY 2002)Lab results (FY 2002) –Lab Costs (FY 2002)Lab Costs (FY 2002) –Separated Inpatient andSeparated Inpatient and outpatient files by visnoutpatient files by visn
  20. 20. VISN DatabaseVISN Database  All (not selected) LaboratoriesAll (not selected) Laboratories  PharmacyPharmacy – All pharmacy prescriptions filed betweenAll pharmacy prescriptions filed between 1997 and 20051997 and 2005  Health Factors (e.g. smoking, alcohol)Health Factors (e.g. smoking, alcohol)  Vital Signs and AnthropomorphicVital Signs and Anthropomorphic DataData – Blood pressure, pulse, height, weight,Blood pressure, pulse, height, weight, BMIBMI
  21. 21. SummarySummary  VA data is a massive national resourceVA data is a massive national resource  Administrative data has drawbacksAdministrative data has drawbacks  Electronic records with good infrastructureElectronic records with good infrastructure but charts remain hard to abstractbut charts remain hard to abstract  Efforts underway to add blood samplesEfforts underway to add blood samples and extract genetic dataand extract genetic data  Support from experts in medicine, IT,Support from experts in medicine, IT, epidemiology, and statisticsepidemiology, and statistics