IBD in the UK improving patient outcomes and experienceDDF, London 25th June 2015

IBD research the combined use of routinely collected health related information with linkages to the Registry and how that benefits research

Keith Bodger Consultant Gastroenterologist, Aintree Hospital IBD Steering Group Member UK IBD Registry Research Committee Lead

Service Delivery

RCTs, long regarded as the gold standard have been put on an undeserved pedestal. Their appearance at the top of hierarchies of evidence is inappropriate. They should be replaced by a diversity of approaches that involve analysing the totality of the evidence-baseObservational studies are also useful and, with care in the interpretation of results, can provide an important source of evidence about both the benefits and harms of therapeutic interventions

It is increasingly recognized that conclusions drawn from classical clinical trials are not always a useful aid for decision-making - assessing the value of a drug or technology requires an understanding of its impact on current management in a practical, real-life setting.Real world data

Cost inputsEffectiveness of standard careRandomized Controlled TrialsReal world Observational dataEfficacy

Missing casesMissing dataSelected centres

Patient Management System (InfoFlex)PMSWeb-based Tool Web PortalLocal Database (e.g. Ferring, Ascribe) Existing Systems

Health and Social Care Information Centre (HSCIC)Data Safe Haven

Receives and pseudonymises the data files from hospitals

Allocates Registry identifier and maintains data file linking NHS number and Registry identifier

Extracts and forwards data from HES and ONS datasets e.g. Death, cancer, hospital data etc.

IBD Registry PMS using InfoFlex software

Hospital or GI Dept IBD database

e.g. Ascribe, Ferring, Hospital EPRLegacy IBD database(on PC in hospital) Overview of Registry data-flow & pseudonymisation in EnglandWeb Tool access(Registry data set, national audit data and research data)IBD Registry web servers

Web Tool databasesSeparate database for each Trust/Board Patient identifiable data encrypted and accessed only by hospital users who then export their data to the Registry.

The Registry Database for audit and research

All export through secure networks to HSCIC.Local Trusts/Boards iBD Registry, April 2015Data extract files from web tool returned to Trust server before upload to HSCIC. N3

AgeTrust ATrust BTrust CTrust DTrust ETrust FDemographics

Contacts

Medication

Current diagnosis (UC, CD or IBD-U)Date of diagnosisDate of symptom onsetConsent-related itemsUC extent: Proctitis, distal, extensiveCD classify: Location and behaviourSmoking statusDrugsAdmissionsSurgeryMinimum dataset

Current diagnosis (UC, CD or IBD-U)Date of diagnosisDate of symptom onsetConsent-related itemsUC extent: Proctitis, distal, extensiveCD classify: Location and behaviourSmoking statusDrugsAdmissionsSurgeryMinimum datasetHospital Episode StatisticsInpatient & Daycase EpisodesOutpatient attendanceAccident & Emergency attendance

Current diagnosis (UC, CD or IBD-U)Date of diagnosisDate of symptom onsetConsent-related itemsUC extent: Proctitis, distal, extensiveCD classify: Location and behaviourSmoking statusDrugsAdmissionsSurgeryMinimum datasetHospital Episode StatisticsInpatient & Daycase EpisodesOutpatient attendanceAccident & Emergency attendance

Trust ATrust BTrust CTrust DTrust EInpatient Care

Research Designs

An Ark is a secure data analytics facility that will bring together the right mix of skilled people, with the data, analytical methods and infrastructure and tools to provide continuous improvement and innovationEvidence produced by services can be rapidly analysed, service improvements identified and then implemented, and new evidence producedThe whole purpose of the Ark is to fundamentally change the relationship between service and research and how that linkage is thought of and what it is expected to be

A data Ark for the IBD community?

Service Delivery

ConclusionsThe IBD Registry offers an opportunity to serve as a powerful vehicle to support service delivery, audit and researchA secure ARK to host data for real-world studiesPlatform for prospective research an off-the-shelf solutionData content, structure, capture, linkage and supporting analytics will continue to evolveKey to success? Stakeholder engagement and incentives

IBD in the UK improving patient outcomes and experience

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