DATA PROTECTION
AND RESEARCH
Implications for a
National Out-of-Hospital Cardiac Arrest Register
(OHCAR)
Siobhán Masterson, Project Manager – OHCAR
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Overview
• OCHAR in Summary:
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Rationale and Background
Purpose
Project Plan
OHCAR Dataset
Data Sources
• Data Protection Issues
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Communication Plan
Security and Confidentiality
Methology1 – De-identified Data Collection
Necessity of collecting patient-identifiable data
Methodology2 – Pseudonymised data collection and the
opportunity for long term patient follow-up
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Rationale
Report of the Task Force on Sudden Cardiac Death
(2006) – Recommendation 6.5:
“PHECC should build on work already
under way to establish a register of
witnessed cardiac arrest and attempted
resuscitation”
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Background
1992 “SAVES” database established
2005 Update of SAVES database
Jun 06 Proposal for OHCA register to Irish Society of
Immediate Care (ISIC) conference
Aug 06PHECC agree to support proposal
Sep 06 NUI Galway agree to take part in Project
Oct 06 Funding secured from PHECC
Mar 07Inaugural Steering Group meeting held
Jun 07 Project Manager in post
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Purpose
• Very little information on OHCA in Ireland – research is
required
– Quantify and describe OHCA
– Analysis of the determinants of survival/death
– Analysis of the effect of interventions on survival/death
• Standardised reporting in the ‘Utstein Style’
• Pre-hospital care service planning e.g.:
– Gothenberg – identified appropriate PAD locations based
on registry results
– Ontario, Cananda – demonstrated value of citizen CPR
and rapid defibrillation responses over advanced life
support
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Project Plan
• Timeframe – 3 years
• Development and implementation of a research
agenda
• Implementation Phase – Start data collection in
the North West Area by end of 2007
• Evaluate implementation phase in North West
• Phased expansion of OHCAR across all HSE areas
• Project close and handover
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The OHCAR Dataset
• Utstein Dataset
• Data collection continuum:
Emergency call receipt in Ambulance Control
Centre
Date of hospital discharge (…and beyond???)
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Primary Data Sources
• Ambulance Control Incident Log (IL)
– Time interval data
– x,y co-ordinates of incident and ambulance
location when assigned
• Ambulance Patient Care Report (PCR)
– OHCA incident data
• Hospital
– Hospital Outcome data
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Data Protection
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Communication Plan
• General Public
– Media launch of OHCAR
• Ambulance service staff
– Information letter
– Information sessions for Lead EMTs, EMCs
– OHCAR integrated into routine ambulance training
• Hospital Staff
– Information letter
– Co-operation with Hospital Resuscitation Committee and
Resuscitation Officer
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Security and Confidentiality
• OHCAR electronic register:
– SPSS database
– HSE server subject to stringent security and back-up
procedures
– Stored on a folder accessible only to Project Manager via
the HSE internal network only
• Paper data sources
– Access to data restricted to Project Manager
– Stored in a locked, fireproof cabinet in a locked office
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Methodology1 – De-identified Data
Collection
Emergency
Medical
Controllers
Cardiac arrest call
received in
ambulance control
and ambulance
dispatched
Pre-hospital
Emergency Care
Practitioners
Cardiac Arrest
confirmed
Pre-hospital
Emergency Care
Practitioners
Patient Care
Report (PCR)
completed
Ambulance
Control Officer
Report produced
from CAD on all
Cardiac Arrest
calls and
Incident Logs
(IL) printed
Hospital
Resuscitation
Training Officer
Data retrieved
from admitting
hospital
OHCAR Project
Manager
Feedback provided
to stakeholders on
a regular basis
OHCAR Project
Manager
Preset reports
produced
OHCAR Project
Manager
De-identified
data entered on
OHCAR
OHCAR Project
Manager
Unique identifier
allocated to deidentified data
Ambulance
Officer, Clinical
Audit Dept
PCR retrieved
from ambulance
clinical audit
department
N
Y
OHCAR Project
Manager
Copies of PCRs
and ILs collected
from Clinical
Audit
Department
Was the
patient
pronounced
dead before
hospital
admission?
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Methodology1 – Lost Opportunities
• Data reporting only to point of hospital discharge
• Ability to verify data compromised e.g. comparison
with death registration data not possible
• Long-term studies not possible
– Highly desirable function of OHCAR:
• Langhelle et al, 2003 - Norway study
demonstrated that in-hospital factors are
associated with survival after OHCA
• De-identification of OHCA data is NOT best
international practice
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Methodology2 – Pseudonymised
Data Collection
Emergency
Medical
Controllers
Cardiac arrest call
received in
ambulance control
and ambulance
dispatched
Pre-hospital
Emergency Care
Practitioners
Cardiac Arrest
confirmed
Pre-hospital
Emergency Care
Practitioners
Patient Care
Report (PCR)
completed
Hospital
Resuscitation
Training Officer
Data retrieved
from admitting
hospital
OHCAR Project
Manager
Feedback provided
to stakeholders on
a regular basis
OHCAR Project
Manager
Preset reports
produced
Ambulance
Control Officer
Report produced
from CAD on all
Cardiac Arrest
calls and
Incident Logs
(IL) printed
OHCAR Project
Manager
Status of
survivors
reviewed
periodically
OHCAR Project
Manager
Pseudonymised
data entered on
OHCAR
OHCAR Project
Manager
Data
pseudonymised
(linked identifier
used)
Ambulance
Officer, Clinical
Audit Dept
PCR retrieved
from ambulance
clinical audit
department
N
Y
OHCAR Project
Manager
Copies of PCRs
and ILs collected
from Clinical
Audit
Department
Was the
patient
pronounced
dead before
hospital
admission?
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Issues with Consent
• If consent is required for follow-up of surviving patients,
validity of findings will be questionable:
– Al-Shahi et al, 2005 – clinically important variables can be
associated with consent preferences
– Buckley et al, 2007 – Significant association between
consent and lower cholesterol, lower blood pressure,
being an ex-smoker and undergone angioplasty
• Approaching ill patients to obtain consent – ethically
questionable
• Practicality of obtaining consent – ongoing co-operation from
variety of emergency department, coronary care and intensive
care unit staff in each hospital nationwide
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Summary to Deputy Data
Commissioner
• The public will be informed about OHCAR and
regular anonymised feedback will be provided to
data providers
• Using the de-identified data methodology:
– Patient identifiable data will not be included on
the electronic register
– Patient follow-up will cease at point of hospital
discharge
• Long term follow-up of patients is an important
issue – guidance required!
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Initiating OHCAR – Our Approach
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Approved by NUI Galway Research Ethics Committee
Phase One – start collecting data in the North West Area
– Go-live 1 November 2007
– Data collection commences 30 November 2007
Data collected from ambulance and hospital sources by a HSE
employee with a contracted duty of patient confidentiality
Patient-identifiable information will not leave the HSE domain
Stringent physical and electronic security measures in place for paper
and electronic data
Patient-identifiable information will be entered on OHCAR
Data validity and quality assurance checks
Periodic reporting of aggregated anonymised data at regional, county
and ambulance station level
Media launch once OHCAR up and running
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Beyond Phase One – Data Protection
Considerations
• Deceased patients:
– GPs
– Cross-referencing with death register
• Non-HSE data sources
– GPs
– Non-HSE hospitals and ambulance services
– First Responders
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