PowerPoint Presentation

IBD ResearchKeith BodgerUniversity of Liverpool

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 care

Randomized Controlled Trials

Real world Observational data

Efficacy

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.

Data files from hospitalsIBD 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.Pseudonymised data file from HSCICLocal Trusts/Boards iBD Registry, April 2015Data extract files from web tool returned to Trust server before upload to HSCIC. N3

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 statusDrugsAdmissionsSurgery

Minimum dataset

Hospital 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 statusDrugsAdmissionsSurgery

Minimum dataset

Hospital Episode StatisticsInpatient & Daycase EpisodesOutpatient attendanceAccident & Emergency attendance

AgeTrust ATrust BTrust CTrust DTrust ETrust F

Demographics

Contacts

MedicationTrust ATrust BTrust CTrust DTrust EInpatient Care

Missing casesMissing data

Selected centres

Research DesignsAn 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 DeliveryConclusionsThe 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