Information for Patients
Patient consent, general information.
When patients are asked to participate in the Euromacs Registry, their physician will give them adequate information about
- Their disease, and the severity of their disease
- The different aspects of their clinical treatment
- The reasons why they’re asked to participate in the Euromacs Registry
- Conditions which Euromacs is bound to with respect to data protection
Here below is a summary of the information a physician gives when a patient receives, or has received, an artificial heart system (Mechanical Circulatory support System, “MCS”).
The ethics committee of the Charité University Hospital in Berlin has approved the full version of the patient information sheet. Euromacs will send the full version to Physicians, who are member of the association, upon request. Beside the English version, a German language version is available as well.
Dear patient,
Your attending physicians have established that you are suffering from a serious disease of the heart muscle that can no longer be treated by medicines. We have advised you to agree to the implantation of a so-called "artificial heart system" (also called a ventricular assist device or VAD, or a mechanical circulatory support system). When you read this, you may already have received such a system.
Your doctor has discussed the surgical procedure in detail with you and has offered you the opportunity to take part in the Euromacs Registry. In the following pages we will inform you of the aims, the procedure and possible risks of participating. Please read this information carefully. Afterwards you will have the opportunity to discuss any questions you have with a doctor.
How is Registry participation organized?
Participation in the Registry is entirely voluntary and is independent of your treatment. If you decide not to participate, this will have no influence on the treatment you receive in our hospital. If you agree to participate, you will be asked to sign a declaration of consent. You may stop participating in the Registry or withdraw your consent at any time without giving reasons. This would in no way be to your disadvantage.
If you discontinue your participation, we will not collect any more data and we will destroy the data already collected.
What is a Registry?
A Registry is a collection of data (information) about patients who are suffering from a particular disease (for example a Tumor Registry) or who undergo a particular kind of treatment, in your case treatment of heart failure with a VAD (see above).
What purpose does the Euromacs Registry serve?
VAD implantation has been available as a standard treatment for only about 15 years. Nowadays many centers worldwide offer this treatment. Each of these centers treats a certain number of patients and has information on these patients only. This information is not sufficient to study the success of VAD treatment as a whole. By pooling the data from many centers in a single Registry, it is possible to make much more reliable studies of the treatment. Its possibilities, limitations and risks can be much better analyzed.
The Euromacs Registry was founded by the German registered association known as the European Registry for Patients with Mechanical Circulatory Support, which is based in Berlin, Germany.
The purpose of the Registry is to collect and evaluate the data of patients with mechanical circulatory support systems. To this end all data are collected in one place in the United Kingdom by a commercial medical database firm (Dendrite Clinical Systems Ltd., The Hub, Station Road, Henley-on-Thames, Oxfordshire RG9 2BA, England). The main aim of the association is to optimize the treatment of patients with a VAD.
What are the alternatives?
Your treatment is entirely independent of whether you participate in the Registry. If you decide not to participate, you will receive the same treatment as any other patient with the same medical condition.
What does participation mean for me?
If you decide to participate, you are asked to sign a declaration of consent. If you do participate, particular data that are collected as a matter of routine before, during and after your operation (for example, your height, weight, length of stay on the intensive care unit, clinical condition after the operation and later on, and various blood test results) will be collected and stored in encrypted form (i.e. pseudonymized to make them anonymous). The data are then sent in pseudonymized form to the Registry at Dendrite Clinical Systems Ltd. in the UK (see above).
In addition we will pass on the results of a questionnaire on your quality of life and information on your job, your level of education and whether you are currently in employment. No special examinations will be performed for the Registry and your participation has no influence on the treatment you receive. The follow-up examinations will take place at the intervals that are usual in your hospital. Your data will be stored for 30 years in the Registry and then be entirely anonymized, so that from then on the data can no longer be identified as yours.
How long does Registry participation last?
We ask your permission to collect data up until your VAD system is removed (e.g. for heart transplantation or if your heart recovers).
Will participation benefit me?
The purpose of the Registry, simply put, is to increase our knowledge of this form of therapy, so that the treatment of patients can be further improved. The knowledge that can be gained by analyzing data from the Registry may have an influence on the treatment we offer. You might therefore personally benefit from new knowledge.
Which centers contribute to the Registry?
The Registry is multicentric, i.e. apart from the hospital in which your are treated, different heart centers in Europe contribute to the Registry. The director of the Registry at the DHZB is:
Who has access to the data stored?
The Registry Organization collects the data. In principle any person or institution interested in a particular question concerning VAD treatment may apply to the organization to be allowed to evaluate data, which remain anonymous to them. A special committee consisting of the directors of the organization decides whether permission is granted.
What risks are attached to participation for me?
We do not anticipate that your participation in the Registry will involve any risks. The potential risk of data misuse will be minimized by strict observance of the legal guidelines on data protection.
Are there any costs, or will I receive payment?
There are no additional costs for you or the hospital beyond the normal costs of treatment. You will receive no remuneration for your participation.
Who can answer my questions?
The doctor treating you will be pleased to answer questions about the Registry and about your participation at any time.
What happens to the results?
All significant results gained during this project that might influence your participation will be sent to you and your doctor.
Will I be covered by insurance?
It was not necessary for us to purchase special patient insurance for this study. The study physician is covered by the general liability insurance of your hospital. Euromacs itself also has a liability insurance for any claims that might result from negligent behavior.
How is data protection guaranteed?
The personal data concerning your health and your illness that will be collected for the Registry, if you agree to participate, will be processed in the following way:
Your personal data (name, sex, date of birth and address) will be noted by the physician on your declaration of consent. This declaration of consent with the uncoded personal information is retained by the doctor. A copy of the form is kept in your medical file. The data collected for the Registry will be encrypted (pseudonymized), stored electronically in this form and passed on to the Registry.
The results gained from the Registry may be published, but no personal data will ever be released.
By agreeing to participate in the Registry you also agree to allow employees of the Euromacs organization and/or their authorized representatives and agents to check your medical file. These people are obliged to maintain confidentiality. The purpose of these checks is to guarantee the accuracy of the data passed on to the Registry.
If you wish, you have the right to information on the personal data stored for you. You also have the right to have any errors in your personal data corrected. Please contact your attending physician (see page 1) if you wish to receive the information.
By signing the declaration of consent you release your attending physician from the obligation of doctor patient confidentiality.