Prevalence of CHD in infants (PAN)

The Prevalence of Congenital Heart Defects in Infants (PAN) study has collected data on the prevalence of congenital heart disease in neonates of three birth year cohorts. The third cohort to be registered ends on 30 June 2009. We therefore ask all pediatricians and pediatric cardiologists in Germany to note the following changes:

• Patients born after 30 June 2009 do not need to be registered for the PAN study.
• It is important that patients born between July 2006 and June 2009 in whom you diagnosed a heart defect in the first year of life are still registered. The database will remain open until the end of 2010.

We would like to take this opportunity of cordially thanking all participants for your cooperation and your dedication to the PAN study. We look forward to working with you again in the future.

The PAN newsletter contains information on the latest patient enrolment statistics, the development of active participants, the patient reports received to date, and the current status of the PAN study. The newsletter is published in German only.

This study being conducted under the auspices of the Competence Network for Congenital Heart Defects is the first prospective study to gather data on the prevalence of congenital heart defects in newborn infants in Germany. The objective is to produce an inventory of heart deformities occurring among birth-year cohorts in Germany. The study intends to gather a complete set of data covering the entire country, an undertaking that has never been attempted on this scale in Germany before. The results of the study will be used primarily for scientific purposes. The aim is to obtain valid figures on the prevalence of congenital heart defects in Germany. The study is being conducted under the scientific directorship of Professor Hans-Werner Hense, Institute of Epidemiology and Social Medicine, University Hospital of Münster, and Professor Angelika Lindinger, Department of Pediatric Cardiology, University Children’s Hospital, Homburg/Saar. The data collection concept has been kept brief in order to obtain relevant data within a relatively short time period, while requiring only a reasonable time expenditure on the part of the reporting units.

All live births after 1 July 2006 will be recorded in which an infant is born with a congenital heart defect, and whose date and place of birth entitles them to German residence.

Paediatric cardiology departments, children’s hospitals, and paediatric cardiology practices all over Germany are taking part in the PAN study. A current list of participants can be found here …

To assure the quality of the data base, and more specifically, to avoid duplication, it is necessary to record the identity data of the patients. This requires the signature of a consent form by the parents/legal guardian, subsequent to oral advice and the receipt of an information leaflet. The reporting unit is responsible for providing advice and handing over the information leaflet, and for obtaining the signed consent form and – with written authorisation – forwarding the patient data to the database.

The data are sent in electronic form directly to the study data center of the Competence Network for Congenital Heart Defects, using a web-based remote data entry system. The only technical requirement is Internet access. Data may exceptionally be submitted on paper only in cases where electronic data transfer is not possible. In such cases, the study co-ordinators will provide details of the prescribed procedure on request.

Data Reports include identification data and a minimal data set.

The identification data are used to identify the record and for the encryption of personal data. They comprise the patient’s name, birth name, date and place of birth, and sex, and the address(es) of the patient and legal guardian.

The minimum dataset contains three sets of data: demographic data, birth data, and medical data.

• The demographic data comprise sex, date of birth, nationality, place of birth in Germany.
• The birth data comprise the first place of domicile after birth, the mother’s age at the time of giving birth, the infant’s birth weight, gestation age, multiple births, prepartal heart defect diagnosis by echocardiography.
• The medical data consist of separate entries for cardiac diagnoses, hereditary, foetal, neonatal and extracardiac diagnoses, together with diagnostic measures. Medical data are encoded by application of a list of  EPC codes.

Compliance with all data protection guidelines drawn up for the Competence Network for Congenital Heart Defects and the National Registry for Congenital Heart Defects is a mandatory requirement for the study. The data protection concept has been approved by the Berlin Commissioner for Data Protection and Freedom of Information in consultation with equivalent offices in the other German Länder, and is legally correct. The full version of the concept can be consulted at the central office of the Competence Network for Congenital Heart Defects. A condensed version (only available in German) can be downloaded here…

It only takes a few minutes to complete the report sheet. At an estimated total of between 4,000 and 6,000 newborn infants with congenital heart defects per year, the monthly workload for an average institution is not likely to exceed 5 reports.

A sum of €25 will be paid for each completed report for an identified patient. If, due to unavoidable circumstances, a report must be submitted anonymously, a sum of €10 will be paid.

Despite the fact that heart defects are the commonest form of congenital organ malformation, we still have no reliable data on the actual number of cases of congenital heart defects, nor on the frequency of individual types of heart defect in Germany.

This is the reason why the Competence Network for Congenital Heart Defects is conducting this scientific study. The aim of the study is to obtain a complete set of data on the number of newborn infants throughout the country born in a given year with a congenital heart defect. This will enable us to establish the prevalence of the disease, the type of heart defects concerned, and their regional distribution. As well as providing a scientific basis for a factual documentation, these population statistics will help to plan, document and promote modern healthcare adapted to the needs of the patients.

The study is being carried out nation-wide, with the participation of numerous paediatric cardiology hospital departments and practising paediatric cardiologists. The data are being collated by the National Registry for Congenital Heart Defects, Berlin, which is responsible for storing the data in accordance with the appropriate data protection requirements.

If you have a child born in Germany with a congenital heart defect, we would be grateful if you would agree to take part in this new study, which will allow us to establish the prevalence of congenital heart defects in new-born infants in Germany. The doctor will be able to provide us with an exact diagnosis of the heart defect and any other congenital diseases where appropriate. In addition to this diagnosis, we also require certain information from you, concerning the pregnancy and birth, your age at the time of giving birth, and the sex, nationality, place of birth and domicile of the child. To show your agreement to take part in this study, please mark the first box on the consent form (PAN study) (see downloadable form “PAN parents’ information/consent form“, available in German only).

If you furthermore agree to allow the National Registry for Congenital Heart Defects to contact you directly from time to time for the purposes of other scientific and social-medical surveys (e.g. a follow-up study to this study or a study of the well-being of children with heart defects), then please indicate your agreement by also marking the second box on the consent form (see downloadable form “PAN parents’ information/consent form“, available in German only).

We have compiled a list of the most frequently asked questions concerning the PAN study.

FAQ / Questionnaire