1 DATA PROTECTION AND RESEARCH Implications for a National Out-of-Hospital Cardiac Arrest Register (OHCAR) Siobhán Masterson, Project Manager – OHCAR

2 Overview OCHAR in Summary: –Rationale and Background –Purpose –Project Plan –OHCAR Dataset –Data Sources Data Protection Issues –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

3 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”

4 Background 1992“SAVES” database established 2005Update of SAVES database Jun 06Proposal 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 06Funding secured from PHECC Mar 07Inaugural Steering Group meeting held Jun 07 Project Manager in post

5 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

6 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

7 The OHCAR Dataset Utstein Dataset Data collection continuum: Emergency call receipt in Ambulance Control Centre Date of hospital discharge (…and beyond???)

8 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

9 Data Protection

10 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

11 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

12 Methodology1 – De-identified Data Collection Pre-hospital Emergency Care Practitioners Patient Care Report (PCR) completed Pre-hospital Emergency Care Practitioners Cardiac Arrest confirmed Ambulance Control Officer Report produced from CAD on all Cardiac Arrest calls and Incident Logs (IL) printed Ambulance Officer, Clinical Audit Dept PCR retrieved from ambulance clinical audit department OHCAR Project Manager De-identified data entered on OHCAR OHCAR Project Manager Preset reports produced Was the patient pronounced dead before hospital admission? Hospital Resuscitation Training Officer Data retrieved from admitting hospital Emergency Medical Controllers Cardiac arrest call received in ambulance control and ambulance dispatched OHCAR Project Manager Feedback provided to stakeholders on a regular basis Y N OHCAR Project Manager Copies of PCRs and ILs collected from Clinical Audit Department OHCAR Project Manager Unique identifier allocated to de- identified data

13 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, Norway study demonstrated that in-hospital factors are associated with survival after OHCA De-identification of OHCA data is NOT best international practice

14 Methodology2 – Pseudonymised Data Collection Pre-hospital Emergency Care Practitioners Patient Care Report (PCR) completed Pre-hospital Emergency Care Practitioners Cardiac Arrest confirmed Ambulance Control Officer Report produced from CAD on all Cardiac Arrest calls and Incident Logs (IL) printed Ambulance Officer, Clinical Audit Dept PCR retrieved from ambulance clinical audit department OHCAR Project Manager Pseudonymised data entered on OHCAR OHCAR Project Manager Preset reports produced Was the patient pronounced dead before hospital admission? Hospital Resuscitation Training Officer Data retrieved from admitting hospital Emergency Medical Controllers Cardiac arrest call received in ambulance control and ambulance dispatched OHCAR Project Manager Feedback provided to stakeholders on a regular basis Y N OHCAR Project Manager Copies of PCRs and ILs collected from Clinical Audit Department OHCAR Project Manager Data pseudonymised (linked identifier used) OHCAR Project Manager Status of survivors reviewed periodically

15 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

16 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!

17 Initiating OHCAR – Our Approach 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

18 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