Presentation given by Alexis Joannides at a Mobile Data Collection seminar at the London School of Hygiene & Tropical Medicine on Sept 27, 2013

1. Electronic
solu-ons
to
clinical
problems?
An
integrated
approach
to
clinical
data
collec0on
and
analysis
Alexis Joannides
Michael Gifford
Email:
aj238@cam.ac.uk

2. The
challenge
of
clinical
data
flow
Clinical
audit
Service
evalua-on
Registry
submission
Transfer
documenta-on
Research
study
Data
capture
Service devolution
across multiple sites
across multiple specialties
Data duplication
operational service
audit and evaluation
academic research
Technical challenges
system compatibility
data compatibility
cost
Commissioning
Cost
Inaccuracy
Healthcare
records
Audit
and
research
data
X
X

3. 1/4/11 – 1/4/12
n = 5099
Real-­‐-me
monitoring
of
neurosurgical
emergency
prac-ce
from
opera-onal
data
0%
25%
50%
75%
100%
Other
No
involvement
Follow-­‐up
Transfer
0
600
1200
1800

4. Approaches
to
mul--­‐site
healthcare
data
collec-on
User
familiarity
Single
point
of
data
capture
Limited
by
quality
of
local
data
Individual
interfacing
requirements
Control
over
data
quality
Rapidly
scalable
and
adaptable
User
training
Local
unit
engagement
Factors to consider
Scalability
Portability
Cost-effectiveness
Adaptability
User involvement

5. Outcome
Registry,
Interven-on
and
Opera-on
Network
(ORION)
a
na-onal
plaTorm
for
integra-ng
clinical
data
collec-on
for
mul-ple
uses
Data
input
Longitudinal
analysis
Cross-­‐sec-onal
analysis
Interfacing
Cloud
repository
Print output
Electronic records
Trial protocol
Disease registry!
Care pathway!
Clinical review!
Desktop
and
tablet
interface
No
local
so8ware
requirement
Two-­‐factor
authen0ca0on
Pa0ent-­‐facing
interface
Data
valida0on
Controlled
modular
access
Single
common
dataset
PDF,
CSV,
graph
output

6. Key
features
• Cloud-­‐based
applicaCon
allowing
secure
and
controlled
access
to
structured
healthcare
informaCon
across
mul-ple
sites
• Custom
applicaCon
modules
u-lising
common
dataset
• Flexible
paCent
idenCficaCon
via
mulCple
unique
idenCfiers
• In-­‐built
record
duplicaCon
safeguards
• OpCmisCc
and/or
pessimisCc
concurrency
checks
to
enable
collaboraCve
work
• Email
communicaCon
to
paCents
/
users
• AutomaCc
PDF
generaCon
for
output
to
other
systems
/
prinCng
• Temporary
local
storage
and
synchronisaCon
for
offline
data
capture
– Prepared
entries
via
token
code
or
pre-­‐loading
– DraQ
mode
for
later
online
reconciliaCon
• Custom
filters
for
real-­‐Cme
analysis
and
CSV
export
for
external
analysis

7. Reconciling
data
protec-on
and
analysis
WebapplicationDatabaseUsers
Data
input
On-screen
view
Document
generation
Data
export
Validation
Metadata
specification
Decryption
Identifier
encryption
StorageBackup
ServiceAdmin Analysis

8. Regulatory
framework
Steering
CommiVee
SoWware
Development
Team
Network
Administra-on
Team
Outcome
Research
Consor-um
Applica-on
support
Log
and
backup
monitoring
Module
development
Record
administra-on
Pilots
and
module
rollout
User
administra-on
Grants
Publica-ons
Annual
reports
Engagement
and
publicity
Data
Monitoring
and
Oversight
CommiVee
Policies
and
procedures
Technical
and
Security
SpecificaCon
SubscripCon
Terms
and
CondiCons
OperaConal
Policy
System
Access
and
Data
Policy
Annual
IG
toolkit
submissions
Society of British Neurological Surgeons
British Neurotrauma Group
British Skullbase Society

9. Current
work
• Network
referral
system
–
neurosurgery
and
neurology
(regional)
• VesCbular
schwannoma
registry
(naConal)
• Major
trauma
rehabilitaCon
(regional)
• SBNS/BNTRC
chronic
subdural
haematoma
audit
(naConal)
• UK
shunt
registry
(naConal)
• Childrens
Epilepsy
Surgery
Service
(naConal)
• NF2
outcome
and
QoL
registry
(regional)
• Integrated
neuro-­‐oncology
care
pathway
(regional)
• Impaired
consciousness
clinical
database
(local)
• Pituitary
surgery
outcome
registry
(naConal)
• UK
cranial
reconstrucCon
registry
(naConal)
• UK
TSHoma
database
(local)
• PSA
community
monitoring
(local)
Development
Pilot
Live

10. 0
10
20
30
40
50
60
70
Pa-ents
recruited
Speed
of
deployment
UK
na4onal
chronic
subdural
haematoma
audit
recruitment

11. Preven-on
Acute
care
Prognosis
Recovery
Long-­‐term
care
ABI
EducaCon
Risk
straCficaCon
Early
detecCon
ResuscitaCon
-­‐
Major
Trauma
Centre
MulCmodality
bedside
monitoring
FuncConal
neuroimaging
Emergence
from
coma
States
of
impaired
consciousness
Late
sequelae
-­‐
hydrocephalus,
epilepsy,
demenCa
RehabilitaCon
-­‐
physical,
cogniCve,
emoConal,
behavioural
Community
re-­‐integraCon
Ongoing
paCent
and
carer
support
AcCve
surveillance
-­‐
UK
shunt
registry
-­‐
EHIG
head
injury
database
DBI
NRS
eRP
CRIC
UKSR
DoS
Data
synergy
Piecing
together
a
heterogeneous
brain
injury
pathway

12. Mobile
devices:
pa-ent
interac-on
Presen4ng
symptom
pa>erns
in
neuro-­‐oncology
(EORTC
QLQ-­‐C30
/
BN20)
0
20
40
60
80
100
0
20
40
60
80
100
0
20
40
60
80
100
n=154

13. Mobile
devices:
clinician
interac-on
Rehabilita4on
complexity
following
major
trauma
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n=69

14. Achieving
sufficient
resolu-on
Trade-­‐offs
in
developing
complex
datasets
• PracCcality
– Who
and
when?
• UClity
– Does
it
jusCfy
the
required
resources?
– Can
this
be
useful
for
mulCple
purposes?
• Applicability
– To
what
proporCon
of
paCents
will
this
apply?
• Accuracy
– How
correct
is
the
data
likely
to
be?
Content
Par--on
Structure
Flow

15. Collec-ng
the
right
data
Defining
a
minimum
dataset
for
accurate
outcome
interpreta4on
Baseline Intervention Outcome
Stratification
Disease stage
Disease subtype
Co-morbidity
Procedure
Complications
Adjuncts
Co-treatment
CROMS
Survival
Imaging
Molecular markers
Biological assays
PROMS
Quality of life
Disease specific

16. IdenCfy
paCent
subsets
amenable
to
novel
intervenCons
Con-nuous
evalua-on
of
high
resolu-on
datasets
Evaluate
impact
of
newly
established
approaches
Monitor
intervenCon
effecCveness
and
safety
Evidence-­‐based
healthcare
policy
and
service
delivery
Healthcare
provision
Clinical
research

17. U-lity
beyond
the
UK
healthcare
se_ng?
• PotenCal
applicaCons
– Cost-­‐effecCve
approach
to
capture
large-­‐scale
observaConal
data
from
rouCne
pracCce
– Outcome
reporCng
for
long-­‐term
condiCons
– Complex
datasets
for
bespoke
research
studies
•
Barriers
to
consider
– Local
infrastructure
and
setup
– Route
to
delivery
and
implementaCon
– PaCent
idenCficaCon
and
cross-­‐referencing
– Funding
model
and
sustainability