FAQ

• Why was the Registry for Congenital Heart Defects created?
• How does the Registry work?
• What is the purpose of the Registry?
• Who can enrol with the Registry?
• What do I have to do to enrol with the Registry?
• Do I have to travel to Berlin to complete any formalities?
• Do I have to pay for enrolment with the Registry?
• When should heart defects be reported, and does this depend on their type?
• Can I opt out of the Registry any time I want?
• How does the Registry keep in touch with patients?
• In what form are the patient data stored?
• Where are the patient data stored?
• Can my identity be traced through data revealed in an analysis?
• What guarantee can be given that the data will remain anonymous?
• Does the Registry disclose patient data to third parties?
• Do I need to inform the Registry if I change my address?
• Can the medical diagnosis be provided by the patient or does it have to established by a doctor?
• Can the Registry provide examinations or treatment?

More than 90 percent of infants born with a heart defect today can expect to survive beyond childhood and live to become adults. This is a relatively new group of patients. There is a lack of generally applicable research findings on the long-term prognosis for congenital heart defects. Until now, it has not been possible to obtain statistically significant results from studies, because the number of patients being treated in individual heart centres in Germany is too small. It is hoped to overcome this deficit by enrolling as many patients throughout Germany as possible in the National Registry for Congenital Heart Defects. This will allow the Registry to serve as a basis for epidemiological studies that have so far been lacking on an international scale. The Registry receives funding from the Federal Ministry of Education and Research (BMBF) as part of its support for the Competence Network for Congenital Heart Defects.

The National Registry for Congenital Heart Defects is the repository for data collected all over Germany on the case histories of patients with congenital heart defects. The patients are regularly asked to supply information on their state of health, the treatment they are receiving and their quality of life. We also work together with the doctors treating these patients. It is only by evaluating these data on a long-term basis that it will be possible to solve the problems that exist in terms of research and patient care. The working methods employed by the Registry are approved by the Länder data protection authorities and monitored by the Berlin Commissioner for Data Protection and Freedom of Information.

The purpose of the Registry is to fill the gap in our knowledge of the medical and social problems faced by patients with congenital heart defects, and learn more about their quality of life. The Registry helps to create a research structure that will enable doctors engaged in medical research to carry out investigations in collaboration with a greater number of heart centres.

Any patient with a congenital heart defect can enrol with the Registry. There are no restrictions concerning the patient’s age or type of heart defect: patients with both minor and extremely severe heart defects are accepted. Adult patients (18 years and over) can enrol themselves. Applications for children have to be submitted by the child’s legal guardian. Enrolment with the Registry is free of charge.

There are two alternative ways of applying to join the Registry:

1. You can apply directly in writing using a standard form, the consent form. After you have sent the completed consent form to the Registry’s office in Berlin, you will receive a letter asking you to fill in a one-page questionnaire dealing with your state of health and current personal situation. Incidentally, the consent form can be downloaded from the Internet.

2. You may be able to obtain a consent form from your paediatric cardiologist (or from the paediatric cardiology outpatient service at the heart centre where you are receiving treatment), who will then forward it and the questionnaire to us along with those of other patients. If you release the doctors from the obligation of observing medical secrecy, a copy of your case notes can be sent to the Registry as well. This will provide the Registry with detailed information on the diagnosis.

No. The application procedure and all subsequent communication with the Registry project team are carried out exclusively by post.

No. There is no charge for being enrolled with the Registry. The only expense incurred by patients is the postage for returning 1 or 2 questionnaires to the Registry each year (standard letter rate).

As a matter of principle, all heart defects, regardless of whether they are minor or severe, should be reported at the time of diagnosis. However, cases of patent foramen ovale (PFO) and patent ductus arteriosus (PDA) should not be reported until a child is at least 6 months old, if the condition is still present.

Yes. Enrolling with the Registry is a voluntary decision. Even if you have submitted a consent form, you can leave the Registry any time you want without having to specify a reason. Choosing to opt out of the Registry does not have any negative personal consequences.

All communication with a patient or their legal guardian is conducted by post or through the intermediary of the regular physician(s). The Registry’s office does not carry out any medical examinations. Your medical treatment remains in the hands of your chosen medical practitioner(s).

Patient data are stored in the Registry according to the prevailing data protection laws in the relevant Land. The project has been registered under code 531.390 with the Berlin Commissioner for Data Protection and Freedom of Information (Dr. Metschke, phone +49 (0) 30/13889305). The anonymity of all data is always respected in analyses and publications. There is no way in which data can be traced back to a specific individual.

Patient data are stored in two separate databases, one containing personal data (name, address, phone number, sex, etc.) and the other containing medical data. Access to the first, or “identity”, database is restricted to a very small number of staff working for the Registry. These staff are responsible for managing the patients’ personal data and updating them when required, e.g. change of name or address. Patients’ identity data are kept strictly apart from their medical data. Medical data are stored and analysed in the second database, the actual Registry. These data are pseudonymised, which means that each patient is allocated a random code that obscures their identity when the data are subsequently processed. Staff working with the pseudonymised medical data are unable to trace any information back to an individual patient. To enable groups of patients with a specific heart defect to be contacted again in the later course of the project, the random code is transferred back to the identity database, where it can be decrypted. This permits the patients to be contacted again (by post).

All analytical findings based on data in the Registry are entirely anonymous and do not allow individual patients to be identified. Personal data and details of medical diagnoses are kept strictly apart. Patients’ medical data are stored and evaluated exclusively under the use of codes (pseudonyms). Even the staff working for the Registry are unable to draw a correlation between individual patients and a specific heart defect (see: Where are the patient data stored?).

German data protection legislation (Section 40 of the Federal Data Protection Act) requires that data be published anonymously except in cases where the patient has granted his/her explicit authorisation.

No. The Registry has a legal obligation towards the patients not to disclose any data that might allow an individual’s identity to be revealed, e.g. name, address, telephone number, to any third party. If the Registry wishes to use data on patients with a specific heart defect for a scientific study, these patients will be contacted by the Registry, or by the heart centre at which they are receiving treatment, or by their (paediatric) cardiologist, and asked to give their explicit consent for the relevant data to be made available for scientific studies.

Yes. This is very important, otherwise it will not be possible to contact patients enrolled in the Registry to take part in future surveys.

In the first questionnaire, patients should provide the diagnosis as they themselves understand it. To do this, patients are asked to request a detailed diagnosis from the doctor who is treating their condition. Many patients also enclose a recent copy of the doctor’s case notes, which include diagnostic results. From this point onwards, any questions concerning the diagnosis should be answered in consultation with the doctor.

No. The Registry merely records the data that have been received by post and stores them in a database. No provision has been made for personal visits by patients to the Registry’s office. Treatment is provided, as before, by the patient’s regular paediatric cardiologist, outpatient paediatric cardiology service or heart centre. The Registry does not make any recommendations concerning the doctor to be consulted.