History and Funding
The registry was established in 1979 and joined EUROCAT in 1980. The registry is located within the Quality and Clinical Care Directorate (Health Intelligence) of the Health Service Executive. Staffing includes a full-time paediatric nurse/researcher and a specialist in public health medicine who works part-time with the registry. In addition, there is limited secretarial support. Funding is provided by the Department of Health through the Health Service Executive.
Population Coverage
The registry is population-based I, which includes all mothers resident in the Health Service Executive area covering the counties of Dublin, Wicklow and Kildare in the east of Ireland. A little more than one-third (25,000 births) of all births in Ireland occur in the area of coverage.
Sources of Ascertainment
There is surveillance of all live births and stillbirths. Children with a congenital anomaly are included in the registry when diagnosed up to the age of 5 years. Multiple sources of ascertainment are used, including information from maternity and paediatric hospitals, governmental vital statistics, medical genetics services and hospital discharge information. As a consequence of data protection restrictions, most of the data used by the registry in the ascertainment of cases is anonymised. This is more a passive process than the active approach formerly used by the registry. As such, the use of multiple sources of ascertainment is therefore essential in the verification and validation of cases, but is more time consuming and has led to a time-delay in the ascertainment of many categories of anomaly.
There is no electronic data access or transfer by the registry from data sources, nor web transfer process. The registry receives an anonymised case list with diagnoses from the local paediatric cardiology centre; the centre would include virtually all cases resident in the registry catchment area. The cytogenetic centre within the region supplies an annual anonymised list to the registry of samples tested, with karyotyping and diagnostic details. The centre includes the majority of samples tested within the registry population, though not all.
Maximum Age at Diagnosis
Up to the age of 5 years.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy for congenital anomaly is not legal in Ireland.
Stillbirth and Early Fetal Deaths
Babies born without signs of life with a gestational age of >=24 weeks or a weight of >=500g are registered. Early fetal deaths/spontaneous abortions are not registered. National autopsy rates only were available for 1999 for the following: stillbirths 50-60% and early neonatal death (0-7 days) 50-60%. There has been a decrease in the proportions having an autopsy in the registry catchment area to approximately 50% due to controversy arising from the issue of consent.
Exposure Data Availability
For each malformed infant reported, very limited or no information is given on certain exposures.
Denominators and Controls Information
Denominator data are supplied by the government body - the Central Statistics Office. No information is available on controls.
Ethics & Consent
The Registry operates according to Data Protection Legislation in Ireland/European Union. As the data on the vast majority of cases held by the registry are received on anonymised basis, no consent is currently sought or required. No data are provided to third parties and any reports or papers using registry data are on an aggregate basis.
New national legislation on information governance in relation to all health data (including that obtained and held, and analysed by registries) will be published by the Irish Government in late 2010. The legislation will provide the basis for the obtaining and use of all aspects of data / information, including ethical and confidentiality considerations. The precise contents of the Bill in relation to congenital anomaly registries were unknown by mid-2010, although submissions were made by the registry during the prior consultation period.
Address for Further Information
Dr Gerardine Sayers / Ms Virginia Delany,
HSE Registry of Congenital Anomalies - East Quality and Clinical Care Directorate,
Room G29,
Health Service Executive,
Dr Steeven's Hospital,
Dublin 8,
Ireland
Tel: +353 1 6352750/1
Email: gerardine.sayers@hse.ie / virginia.delaney@hse.ie