Frequently asked questions (FAQ)

• 1. What is the most practical procedure?
• 2. What category of patients does the survey cover?
• 3. What are the medical inclusion and exclusion criteria?
• 4. When should the patients be approached (concerning the study)?
• 5. Who is responsible for registering the patients?
• 6. Do I need the approval of an ethics committee in order to take part in the PAN study?
• 7. Why are the data recorded under the patient’s identity rather than anonymously?
• 8. How are the patients’ unique pseudonyms (PID: patient identifier) generated?
• 9. Is it possible for a patient/parents to be contacted directly by the project manager or by the National Registry for Congenital Heart Defects?
• 10. Are any quality-assurance measures applied to the recorded data?
• 11. How can I obtain additional material for the study?
• 12. Does the study co-ordination office need to be informed of any institutional changes?
• 13. What happens to anonymous reports?
• 14. Which data cannot be modified after they have been written to the database, and what do I do if I notice an error after the data have been stored?
• 15. What happens if patient has already been registered with the PAN study?
• 16. What is the most convenient way of entering the medical data?
• 17. Is a “new visit” page opened every time I see the patient for a consultation?
• 18. What needs to be done in the event of a patient’s death?
• 19. Why do we need to send out monthly reminders?
• 20. Are there any charges to be paid for setting up access to the database or transferring patient data?
• 21. What reimbursement of expenses will I receive?
• 22. In what form will the reimbursement be paid?

We recommend that you use a printed version of the survey form when you are presented with the patient for the first time (outpatient or inpatient). The patient label can be glued to it for simplicity. The additional items of data required (demographic data, birth data, medical data) can be added as hand-written entries during a short consultation with the parents. If requested on the same occasion, it is usually relatively easy to obtain the parents’ consent.

The items cannot be entered in the database until you are in possession of the parents’ consent form, which has to be signed jointly by the parents/legal guardian and the doctor in charge.

If you use a printed version of the report form in the first instance, the entries to the database can be made by another person if necessary, at any time, and in any place.

Please ensure that the patient’s PID code and the recorded identification data or a printout are kept in a safe place with the list of patients. You will need the PID later, for processing patient records.

Another useful tip is to keep the paper records of the study data (or a photocopy, or a copy of the computer printout) accessible at your usual place of work, filed in a folder and/or the patient file. This enables you to add information to the forms, if they are not yet complete. Keeping a paper copy of the form on hand also allows you to refer to the original document in the event of queries.

We recommend that you enter the patient data in the database, or send a copy of the survey form to the study co-ordination office, as soon as possible after obtaining the signed consent form. The chances of being able to obtain and add missing items of data are considerably reduced if the survey form is processed much later.

Forms for patients that have been redirected to your in-tray whilst awaiting signature of the consent form should be filed in a special folder and only submitted as anonymous reports after the final date for follow-up examinations has expired.

We require reports of all live births of infants with a congenital heart defect, born on or after 1 July 2006, who acquire German residence at the time of their birth.

All infants with a congenital structural anomaly of the heart or the thoracic vessels that has an immediate or potential functional significance are recorded. This also includes heart defects of subordinate haemodynamic significance, possible only lasting for a short time.

In practice, this means that you should record all infants for whom you can enter a temporary or permanent diagnosis in Part 1 of the selection list under “Primary/secondary diagnosis (congenital)”.

The only exception are children for whom you diagnose a patent foramen ovale (EPC 05.03.01) or an isolated persistent left superior vena cava (EPC 04.03.01), and nothing else. Children with no other diagnoses than these are not registered.

Please note that a patent ductus arteriosus (EPC 09.27.11) only meets the inclusion criteria if it persists beyond the 4th week after the calculated birth date. Report forms for such patients should not be submitted until you have confirmed the diagnosis at the appropriate date.

If you have any further medical questions, please contact:
Prof. Dr. med. Angelika Lindinger
Phone: +49 6841 16-28306
E-mail: kialin(at)uniklinikum-saarland.de

Wherever possible, please complete the survey form on the first occasion on which you deliver a diagnosis, unless you are certain that the patient has already been registered with the PAN study.

Obviously, in certain cases, it may be difficult to speak to the parents about enrolling in the PAN study and to obtain their consent at your very first meeting. In such cases, it is advisable to make use of a follow-up visit for this purpose, if it takes place with you or at an institution to which you have referred the patient within the following few weeks.

Your own institution is responsible for registering the children if:
- they are being cared for in your institution,
- they have been referred to you from another institution and have not yet been registered,
- the next follow-up examination is likely to take place after the child’s first birthday.

If a patient is only in your charge for a short time, this patient’s data should be reported by the institution that takes over responsibility for subsequent diagnostic tests and treatment. This depends on the particular way medical care is organised in your locality, and the forms of co-operation involved, and therefore needs to be handled on a case-by-case basis. If you do not register a patient who has been transferred elsewhere, please inform the new institution of this fact.

If you have the certain knowledge that a patient has already been registered by another institution, you do not need to register that patient again.

A list of active partners in the reporting process is provided here …

The PAN study is being conducted in accordance with a data protection concept that is valid for the entire Competence Network for Congenital Heart Defects. It applies the same basic principles as the generic solution published by the Telematics Platform for Medical Research Networks (TMF e. V.) for data protection in medical research networks (Reng CM et al., Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft, 2006 - one of a series of publications by the Telematics Platform for Medical Research Networks (TMF e. V.) - ISBN 3-939069-04-3 - ISBN 978-3-939069-04-1), which has been approved for use throughout Germany. The present concept has been approved by the Berlin Commissioner for Data Protection and Freedom of Information, in consultation with the equivalent officers in all other German federal states (Länder).

A vote of approval for the PAN study has also been obtained from the ethics committee of the Charité hospital in Berlin. It is the considered opinion of the German Epidemiological Association (DGEpi), based on its long experience and in particular its close collaboration with the working group of medical ethics committees (Wichmann HE et al., Deutsches Ärzteblatt 2002, 99: A 3243-A3244) and the scientific working group that oversees the work of data protection officers at national and regional level (Wichmann HE et al., Datenschutz und Datensicherheit 1999, 23: 100-103), that a single voting procedure for all centres and doctors participating in a study is sufficient in the case of multi-centric epidemiological observational studies – which are not covered by the German Drugs Act (AMG). This is the case of the PAN study, and no problems have been experienced in the past with many other studies of a similar nature.

The use of anonymous data would not allow us to exclude the possibility of including the same patient more than once, through reports from different institutions: indeed this would be inevitable. In the interests of quality assurance, and more particularly as a means of avoiding duplicate entries, it is necessary that patients should be assigned a unique pseudonym (PID: patient identifier), which enables an individual patient to be identified but cannot be used to decipher their personal data.

A unique pseudonym (PID) is generated for each patient from the set of identification data comprising their first name, surname, birth name, date of birth and sex, using a special online routine during the input of the patient data. If this is not sufficient to clearly differentiate two patients (e.g. bearing common names such as Klaus Müller), then parts of their address (city and street) are added as a further differentiation criteria. This method was developed by a working group of the Telematics Platform for Medical Research Networks (TMF e. V.) and complies with the strictest data protection requirements (Reng CM et al., Deutsches Ärzteblatt 2003, 33: A2134-A2137). The algorithm used to generate PIDs has been designed in such a way that it is impossible to retrieve elements of the patient’s identity by “calculating backwards”.

The identification data recorded for the PAN study are used solely to generate PIDs. The only possibility for the project manager or the National Registry for Congenital Heart Defects to enter into contact with a patient is if:

a. this option was expressly requested on the parents’ consent form, or
b. the patient was declared as being enrolled in the National Registry in the demographic data included in the minimum dataset.

Parents who have accorded their permission for the data to be used only in connection with the PAN study cannot be contacted by the study co-ordination office.

The PAN study was designed as a quality-assured National Registry study under the auspices of the Competence Network for Congenital Heart Defects. The following internal quality-assurance measures have been implemented to ensure a high quality of data:

- Records contain a minimum of data items.
- Essential data are entered in mandatory fields.
- Plausibility checks are run in the database.
- Look-up tables of EPCs are linked to the fields requiring diagnosis information – free text input of medical data is not possible.

Moreover, external quality assurance is provided by the Coordination Center for Clinical Studies (KKS) in Berlin. Every six months or so, a 5% random sample of the reports is verified by a monitor who checks the completeness and plausibility of the entries in the database (data source verification). This monitoring process is expressly supported by the scientific advisory body appointed by the German Federal Ministry of Research and Education (BMBF).

All material you might require for the study (consent forms, report forms, study manual, selection list), as well as PAN posters and flyers, will be sent to you by the study co-ordination office on request:

Dr. Gerda Schwedler (study co-ordinator)
Phone: +49 30 450-576775, -576774 (Mon-Fri 10 a.m. to 3 p.m.)
Fax: 030 450-576972
E-mail: pan(at)kompetenznetz-ahf.de

All forms (in German only) can also be downloaded here …

Please inform us if there are any staff changes in your institution that affect the PAN study, or if there are any changes of address. We also need to know if your bank account details have changed. This ensures that any correspondence from us is sent to the correct addressee.

The only reason for sending in anonymous reports is if you have not been able to obtain the consent of the parents/legal guardian. In this case, please complete the form “PAN: anonymous report“ and sent it to the study co-ordination office.

If a patient for whom you have sent in an anonymous report be brought to you for consultation again at any time during the study period, and this time agrees to sign the consent form, then please submit an identified report. At the same time, please inform the study co-ordination office which anonymous patient from your institution can now be deleted from the database, to avoid duplicate entries.

The identification data cannot be modified after they have been stored. For this reason, please take special care to check that these data are correct before storing them in the database. In particular, please ensure that first names, surnames and birth names are spelt correctly, and that the correct format/codes are used for date of birth and sex, because these items are used to generate the PID.

If you notice an error after the data have been stored, make another entry for this patient using the correct data, and call, fax or e-mail the study co-ordination office to inform them about the incorrect entry, so that they can delete it and ensure that the patient isn’t counted twice.

A further item that cannot be modified is the date of “creation of case visit plan”, where you enter the date on which the dataset was first created. But this date is of no significance to the PAN study itself.

If a patient has already been registered by another hospital or doctor participating in the study, input of the identical PID (eight-digit pseudonym) will result in the following error message:

Error! You are not entitled to process this patient’s data

and you will no longer be able to enter the minimum dataset. In this case, please send the completed survey form (on paper) marked with the corresponding PID and a note stating that it refers to a duplicate report to the study co-ordination office, and you will receive payment of expenses for this patient too.

All items in the medical data are structured in the same manner. The only way you can enter data is by selection from the linked look-up table (extract of the selection list).

If you know the EPC that corresponds to the characteristic you wish to describe, enter it in the appropriate field. When you save the code, the corresponding description will be added automatically – all you need to do is confirm the entry.

Do not attempt to write your own text in the text field. The entry will only be stored if it exactly matches one of the selection options in the look-up table.

If you want to look up the possible options for a characteristic, the best way to do this is to use the “List” button. This function allows you to scan through the part of the selection list linked to the field in question, or to narrow down the search by entering key words, groups of words or codes.

No, all modifications and additions can be made and viewed in the page for the first visit. The “new visit” function is intended for use in clinical trials, and is not relevant to the PAN study.

If you wish to modify the primary diagnosis after having seen the patient again, please overwrite the old diagnosis. The fields for all other diagnoses and diagnostic measures allow you to add additional data by clicking on the “Add” button.

The clinical outcome – including the possible death of a patient – is not considered in the PAN study.

If a patient has died, mark the answer “no” to the question “Is the patient a member of the National Registry?”, regardless of what is stated on the parents’ consent form. This removes the possibility of the parents being contacted at a later date by the study co-ordination office.

Please do not make any entry in the “patient exit” field under “patient status”, because this would result in the dataset being irrevocably blocked against any further data input.

If we have not received any input to the database or reports on paper from you in the last month, a reminder will be sent to you by e-mail or fax. We do this routinely for all institutions. The only exception are reporting units that send in reports at less frequent intervals, but nevertheless regularly.

The purpose is to remind you to send in any report forms you might have. This helps us to even out the volume of reports received from month to month, and also ensures that we meet the study’s objective of complete reporting of all cases.

Database access and data transfers are free of charge for all reporting units, who merely have to pay their own Internet charges.

If you have any problems accessing the database, or require help with any other organisational matter, support is provided by:

Dr. Gerda Schwedler (study co-ordinator)
Phone: +49 30 450-576775, -576774 (Mon-Fri 10 a.m. to 3 p.m.)
Fax: +49 30 450-576972
E-mail: pan(at)kompetenznetz-ahf.de

To cover your expenses, a sum of €25 will be paid for each identified patient for whom you enter a complete set of data in the database of the Competence Network for Congenital Heart Defects or send in a completely filled-out report form. If, due to unavoidable circumstances, a report must be submitted anonymously, a sum of €10 will be paid.

These sums include VAT where applicable. No general answer can be given to the question of whether you are required to pay VAT on this income, because this depends on the level of your earnings and on the legal status of your institution. Please refer such questions to your book-keeping department or tax accountant.

The money will be transferred to your bank account. To do this, we require your bank details and your tax number, which you can send to us using the specially prepared form.

These payments are made from the research funds granted to the Competence Network for Congenital Heart Defects by the German Federal Ministry of Education and Research BMBF (BMBF-FKZ 01GI0601).

Your entitlement to reimbursement of expenses is based on your intention to take part in the PAN study, as documented by your signature of the application form.

You will be credited for the number of patients you have registered on a quarterly basis. The entries you have made in the database serve as proof of the number of reports you have made for identified patients. The report forms received by the study co-ordination office serve as proof of any anonymous reports.