IBD in the UK

improving patient outcomes and

experience
DDF, London
25th June 2015

Service
Deliver
y

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-base

Observational 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

Real world data

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.

Randomized
Controlled Trials

Real world
Observational data

Cost inputs

Efficacy
Effectiveness of
standard care

Selected
centres

Missing
cases

Missing data

PMS

Web Portal

Existing
Systems

Patient Management System

(InfoFlex)

Web-based Tool

Local Database (e.g. Ferring,

Ascribe)

Overview of Registry data-flow & pseudonymisation in England

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

Pseudonymise
d data file
Receives and pseudonymises from HSCIC

IBD Registry web

servers
The Registry
Database

the data files from hospitals

for audit and research

Allocates Registry identifier

and
maintains data file
linking NHS
number and
Registry identifier

Web Tool
databases

Separate database for each

Trust/Board
Data files
Patient identifiable data
Extracts and forwards data
from
encrypted and accessed only
from
HES and ONS
hospitals
by hospital users who then
datasets
export their data to the
e.g. Death, cancer, hospital
Registry.
All export through secure networks to HSCIC.
Localetc.
Trusts/Boards
data
Legacy IBD
database
(on PC in
hospital)
iBD Registry, April 2015

Hospital or GI
Dept IBD
database
e.g. Ascribe,
Ferring, Hospital

IBD Registry
PMS using
InfoFlex
software

Data extract
files from
web tool
returned to
Trust server
before upload
to HSCIC.

N
3
Web
Tool
access

(Registry data
set, national

Demographics

Trust A
Trust B
Trust C
Trust D
Trust E
Trust F
Age

Contacts

Medication

Minimum dataset

Current diagnosis (UC, CD or IBD-U)

Date of diagnosis
Date of symptom onset
Consent-related items
UC extent: Proctitis, distal, extensive
CD classify: Location and behaviour
Smoking status
Drugs
Admissions
Surgery

Minimum dataset

Current diagnosis (UC, CD or IBD-U)

Date of diagnosis
Date of symptom onset
Consent-related items
UC extent: Proctitis, distal, extensive
CD classify: Location and behaviour
Smoking status
Drugs
Admissions
Surgery

Hospital Episode Statistics

Inpatient & Daycase Episodes

Outpatient attendance
Accident & Emergency attendance

Minimum dataset

Current diagnosis (UC, CD or IBD-U)

Date of diagnosis
Date of symptom onset
Consent-related items
UC extent: Proctitis, distal, extensive
CD classify: Location and behaviour
Smoking status
Drugs
Admissions
Surgery

Hospital Episode Statistics

Inpatient & Daycase Episodes

Outpatient attendance
Accident & Emergency attendance

Trust A

Trust B

Trust C

Trust D

Trust E

Inpatient Care

Research Designs

A data Ark for the IBD

community?
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 innovation
Evidence produced by services can be rapidly analysed,
service improvements identified and then implemented,
and new evidence produced
The 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

Service
Deliver
y

Conclusions
The IBD Registry offers an opportunity to serve
as a powerful vehicle to support service delivery,
audit and research
A secure ARK to host data for real-world
studies
Platform for prospective research an off-theshelf solution
Data content, structure, capture, linkage and
supporting analytics will continue to evolve
Key to success? Stakeholder engagement and
incentives

IBD in the UK
improving patient outcomes and
experience