IBD Research

Keith Bodger
University of Liverpool

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
It is increasingly
data

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

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

IBD Registry web

servers

Pseudonymise
d data file
Receives and pseudonymises from HSCIC

The Registry Database

for audit and research

the data files from hospitals

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

Web Tool databases

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

Extracts and forwards data

from
HES and ONS
datasets
e.g. Death, cancer, hospital
All export through secure networks to HSCIC.
Local
Trusts/Boards
data
etc.
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
audit data and
research data)

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

Demographics

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

Contacts

Medication

Inpatient Care
Elective

Emergency

Elective daycase
1365

RRV

338

Trust A

151
919

RNJ

Trust B

324
83
1298

Trust RHM
C
RF4
Trust D

428
115
1190
661
98
552

Trust E
RC9

308
54

EMERGENCY ADMISSIONS RESULTED IN MAJOR SURGERY; 8%

EMERGENCY ADMISSIONS WITH NO MAJOR SURGERY; 92

Selected
centres

Missing cases

Missing data

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 offthe-shelf solution
Data content, structure, capture, linkage
and supporting analytics will continue to
evolve
Key to success? Stakeholder engagement
and incentives