Using Electronic Pa0ent Record Data to Inves0gate Viral

Hepa00sDavidSmith,UniversityofOxford

Viral Hepa00s

•  Inflamma8onoftheLivercausedbyoneormoreunrelatedvirushepa88sA,B,C,DandE.

• ChronicInfec8onwithHepa88sBorCViruscanleadtoLiverCirrhosisandHepatocellularCarcinoma.

• BotharemostcommonlytransmiGedviacontactwithinfectedblood.• Hepa88sDviruscanonlyreplicateifco-infectedwithHepa88sB.• Hepa88sEcancausesanacutemildhepa88sandismostcommonlyspreadviacontaminatedfood.

StanawayJD,etal.Lancet.2016

StanawayJD,etal.Lancet.2016

NIHR Health Informa0cs Collabora0ve

NIHR Health Informa0cs Collabora0ve: Objec0ves

•  Toproduceexemplarresearchprojects.

•  Providemoderninfrastructuretoallowresearcherstoshareandexploitsecondarycaredataforresearch.

•  EstablishrichlongitudinaldatasetsintheNHSandBRCs.

•  CommongovernanceandPPIframework(includingconsent).

•  Futureproofthesolu8onwithautoma8cdatacapturewhereeverpossible.

•  Improvingelectronicpa8entrecords.

•  EstablishingcomparabilityofdatabetweenBRCs.

•  Crea8nginteroperabilitybetweenITsystemswithinandbetweenBRCs.

•  Industryengagement.

The Challenges of the Viral Hepa00s Theme

•  Largedatasetcovering4dis8nctdiseaseswithuniqueresearchques8ons.

•  5DifferentNHSTrustswithdifferingpa8entpopula8ons,clinicalservicesandITinfrastructures.

•  Fastmovingandcompe88veresearchenvironment.

•  Aneedtodevelopappropriategovernanceforethicallycollec8ngandsharingdataonvulnerablepa8ents.

•  Firstexemplarresearchques8onsare:•  HCV:WhatinfluencestreatmentoutcomeswiththenewDirectAc8ngAn8virals?

•  HBV:ThedeterminantsofHBsAglossandeAgseroconversionintreatedpa8ents?

•  HEV:Whogetsitandwhy?

Conceptual Architecture NIHR HIC , Prof Jim Davies

t h e m e s p e c i f i c c l i n i c a l . d a t a b a s e

s t a n d a r d i s e d c l i n i c a l . d a t a b a s e

a n o n y m i s e d , . s t a n d a r d i s e d r e s e a r c h . d a t a . c a c h e

m e t a d a t a r e g i s t r y

m e t a d a t a . c a t a l o g u e

o p e r a ti o n a l . s y s t e m s

a u t o m a 8c c . d a t a . f e e d s

t r u s t b o u n d a r y

d a t a . e x t r a c t . f o r . s p e c i f i c r e s e a r c h . c o l l a b o r a ti o n

" r e s e a r c h " . s y s t e m s

Therapeu8cServiceSystemsPharmacyRadiotherapyChemotherapy

CernerMillenniumEPR

DepartmentalClinicalSystemsRenalCardiac

Diagnos8cServicesPathologyRadiologyLabs

ClinicalDataRepository(MirthResults)

Iden8tyService(MirthMatch)

OUHOpera8onalSystems

OUHMiddleware

OUHHepatologyDepartmentSystems

Hepa88sClinicalResearchSystem

Reports,Audit,ClinicalReview

TrueColoursServer

-Pa8entNotes-Unconnectedsystems

TrustIntegra8onEngine(MirthConnect)

OtherOutsideSystems

OxfordUniversityPathogenResearchgroup

OUHTrustBoundary

Pa8entPortal

NIHRHICHepa88sResearchRepository

Key Requirements for the OUH Hepa00s Clinical Research Database

•  ImportLegacydata(mostlyexcelspreadsheetsorcsvfiles).

•  Easilyupdatedatasetstoreflectchangingresearchques8ons.

• Robustsecurityanduserroles.

• Customrepor8ngandexpor8ngofdata.

• Pa#ent-centricmanualentry/edi#ngofclinicaldata.

• Automa#cimportofdatafromOUHMiddleware.

Pa0ent Centric Data Entry

•  ThestandardLabKeyworkflowfordataentryisdatasetcentric.

•  Manualentryandedi8ngofdataisakeyrequirementofHepa88sClinicalResearchsystem.

•  ResearchNursesandClinicianswantedawayofenteringdatawhichmakessensetothemandfollowstheirworkflows.

LabKing: Rule over your subjects

• BuiltusingLabKeyJavascriptAPI.

• Canbeusedwithanydatasetsbutrequirestobepointedatanenrolmentdataset.

• Codeavailableatgithub.com/spikeheap/labking

Automated impor0ng of clinical data

Hepa88sClinicalResearchSystem

ClinicalDataRepository

Par8cipantList

LabResults

SubjectsofInterests

SharedTables

TrustClinicalSytemsTrustClinical

SytemsTrustClinicalSytemsTrustClinical

Systems

ResearchSystem Middleware Opera8onalSystems

Therapeu8cServiceSystemsPharmacyRadiotherapyChemotherapy

CernerMillenniumEPR

DepartmentalClinicalSystemsRenalCardiac

Diagnos8cServicesPathologyRadiologyLabs

ClinicalDataRepository(MirthResults)

Iden8tyService(MirthMatch)

OUHOpera8onalSystems

OUHMiddleware

OUHHepatologyDepartmentSystems

Hepa88sClinicalResearchSystem

Reports,Audit,ClinicalReview

TrueColoursServer

-Pa8entNotes-Unconnectedsystems70%

30%

TrustIntegra8onEngine(MirthConnect)

LabKey

~78Klabresults(~100perday)Automa8cfeed

~1200Pa8ents

CDR:~600,000Uniquepa8ents

~30KEPRADTmsgs/day~3KMicrobiologymsgs/day~20KLIMSmsgs/day

HCVResearchUKNa8onalDatabase

OxfordUniversityPathogenResearchgroup

OUHBoundary

Pa8entPortal

NIHRHICHepa88sResearchRepository

On-going Research using OUH Hepa00s Research Data.

•  IncidencesofHepa88sEinpa8entswithunderlyingliverdiseaseinOxfordCohort.

•  Integra8onoflongitudinalclinicaldatawithviralandhostgene8cdatatobeGerunderstandHepa88sCandB.

• DevelopmentofHCVVaccine.•  Integra8onwithviralsequencingtobeGerunderstandresistancetoHepa88sCDirectAc8ngAn8virals.

Future Work

•  Collec8onofminimumdatasetfromallsitesforNIHRHICProject.

•  Analysisofdataforexemplarresearchques8ons.

•  Partnershipswithindustrypartnersincollabora8veanalysisofdata.

•  FurtherDevelopmentofHepa88sClinicalResearchSystem.•  Repor8ng•  Dashboardviewsofkeydata•  Integra8onwithfurtherclinicalsystems•  Automa8ngqualitycontrol

Acknowledgements

•  JimDavies•  KerriWoods•  CharlieCrichton•  JamesWelsh•  SoheilSaifipour•  HizniSalih

•  RyanBrooks•  TimBradford•  JemChalk•  AlexHenderson•  OllieFreeman

•  HepatologyResearchNurses•  LizzieStafford•  DeniseO’donnell•  MarkAinsworth•  AbbieMar8n

•  NIHRHICViralHepa88sClinicalLeads•  EllieBarnes(OxfordThemeLead)•  GrahamCooke(Imperial)•  KoshAgarwal(KingsCollegeLondon)•  EleniNastouli(UCL)•  LydiaDrumright&GraemeAlexander(Cambridge)

•  LabKeyTeam•  BernieLee•  KarlLum•  AvitolSadot

•  OxfordBRCClinicalInforma8csTeam