VA Resources for Dermatology VA 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 the Director of Analysis of Clinical Trials at the Massachusetts Veterans Epidemiology Massachusetts Veterans Epidemiology Research and Information Center Research and Information Center (MAVERIC) (MAVERIC)

Veterans Health Veterans Health AdministrationAdministration

Department of Veterans Affairs

Massachusetts Veterans Epidemiology Research and Information Center

(MAVERIC)Lou Fiore, MD

Michael Gaziano, MDMary Brophy, MD

VA Study Design and Database VA Study Design and Database ResourcesResources

MAVERIC MAVERIC

• • $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

MAVERICMAVERIC

ERIC - Epidemiology Research Information ERIC - 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 tissue VA Core Laboratory - Blood and tissue collection and storage (M. Brophy) collection and storage (M. Brophy)

VA Boston JP CampusVA Boston JP Campus

VA National Centers for VA National Centers for ResearchResearch

12-million electronic patients records 12-million electronic patients records and supporting electronic medical and supporting electronic medical documentsdocuments

Average of 5 years follow-upAverage of 5 years follow-up 7 VA research centers affiliated with 7 VA research centers affiliated with

major universitiesmajor universities Large budgets devoted to veterans’ Large budgets devoted to veterans’

carecare Impressive security and bureaucracyImpressive security and bureaucracy

Centers conducting many large clinical trialsCenters conducting many large clinical trialsMAVERIC - BostonMAVERIC - BostonWest Haven - New Haven West Haven - New Haven Palo Alto – StanfordPalo Alto – Stanford

Centers with epidemiology research programsCenters with epidemiology research programsMAVERIC BostonMAVERIC BostonWest HavenWest HavenDurhamDurhamSeattleSeattle

Centers conducting a few large clinical trials and Centers conducting a few large clinical trials and variety of other large clinical studiesvariety of other large clinical studiesHines – ChicagoHines – ChicagoPerry Point - BaltimorePerry Point - Baltimore

Statins and Melanoma Statins 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 melanoma Do statin users have thinner melanoma lesions?lesions?

Find VA cases of melanoma, assess prior statin Find VA cases of melanoma, assess prior statin use, record Breslow thickness.use, record Breslow thickness.

Found ~1000 melanoma diagnosis, expect ~200 Found ~1000 melanoma diagnosis, expect ~200 path confirmed. Over 90% have thickness.path confirmed. Over 90% have thickness.

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 and Register final analytic dataset and

definitive analyses. definitive analyses.

Set up a randomized clinical Set up a randomized clinical trialtrial

Submit 10-20 page ‘letter of intent’ study Submit 10-20 page ‘letter of intent’ study proposal.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 6-12 The 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 and National VA reviews a set of full proposals and funds a few.funds a few.

Typical multicenter study has 500-2000 Typical multicenter study has 500-2000 subjects with a multimillion dollar budget.subjects with a multimillion dollar budget.

Dr. Weinstock’s StudiesDr. Weinstock’s Studies

Topical tretrinoin chemoprevention Topical tretrinoin chemoprevention of keratinocyte cancer. Completed.of keratinocyte cancer. Completed.

VA Perry PointVA Perry Point

Chemoprevention of keratinocyte Chemoprevention of keratinocyte cancer with field treatment. Awaiting cancer with field treatment. Awaiting final approval.final approval.

VA MAVERIC BostonVA MAVERIC Boston

VA SupportVA Support : Pro and Con: Pro and Con

Electronic data captureElectronic data capture Extensive database structure and Extensive database structure and

servicesservices Continuous expert reviewContinuous expert review Management of remote medical sitesManagement of remote medical sites Statistical supportStatistical support Drawbacks - bureaucracy, security, Drawbacks - bureaucracy, security,

and competition for resources.and competition for resources.

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 12 million enrollees, on average 5 years of

follow-upfollow-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 Data Medicare Data VISNVISN

– Regional data feeds Regional data feeds – Patient ChartsPatient Charts– Ancillary information (pathology pharmacy) Ancillary information (pathology pharmacy)

VA National DatabasesVA National Databases

National Patient Care DatabaseNational Patient Care Database Inpatient and outpatient encounters Inpatient and outpatient encounters ICD-9 diagnosis and procedure data, CPT ICD-9 diagnosis and procedure data, CPT

procedure dataprocedure data

Beneficiary Information and Records Beneficiary Information and Records Locator System (BIRLS) -DeathsLocator System (BIRLS) -Deaths Augment with Social Security Administration Augment with Social Security Administration

DataData

Decision Support Systems DataDecision Support Systems Data CostCost PharmacyPharmacy Selected Laboratory dataSelected Laboratory data

– Creatinine, Total Cholesterol, HDL, LDL, Creatinine, Total Cholesterol, HDL, LDL, Triglycerides, HbTriglycerides, Hb

National Patient Care National Patient Care DatabaseDatabase

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 FY 1997-2005, first 2 quarters FY

20062006 Mortality files (BIRLS and SSA_DMF)Mortality files (BIRLS and SSA_DMF)

National Data: Pharmacy National Data: Pharmacy DataData

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

National Data: Laboratory DataNational Data: Laboratory Data

Lab DataLab Data– Two filesTwo files– Lab Results, Lab Utilization and Lab Results, Lab Utilization and

CostsCosts– Lab results (FY 2000)Lab results (FY 2000)– Lab Costs (FY 2002)Lab Costs (FY 2002)– Separated Inpatient and Separated Inpatient and

outpatient files by visnoutpatient files by visn

National Data: Radiology DataNational Data: Radiology Data

Two filesTwo files Radiology Radiology Utilization and Costs (but no Utilization and Costs (but no images)images)

–Lab results (FY 2002)Lab results (FY 2002)–Lab Costs (FY 2002)Lab Costs (FY 2002)–Separated Inpatient and Separated Inpatient and outpatient files by visnoutpatient files by visn

VISN DatabaseVISN Database All (not selected) LaboratoriesAll (not selected) Laboratories PharmacyPharmacy

– All pharmacy prescriptions filed All pharmacy prescriptions filed between 1997 and 2005between 1997 and 2005

Health Factors (e.g. smoking, Health Factors (e.g. smoking, alcohol)alcohol)

Vital Signs and Anthropomorphic Vital Signs and Anthropomorphic DataData– Blood pressure, pulse, height, weight, Blood pressure, pulse, height, weight,

BMIBMI

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 Electronic records with good

infrastructure but charts remain hard to infrastructure but charts remain hard to abstractabstract

Efforts underway to add blood samples Efforts 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