Updated: 26 January 2012
Information about the ECFSPR for CF Patients
What is the ECFS Patient Registry (ECFSPR)?
We all use lists in our lives and a registry is another name for a list, a registry is merely a secure place where the list is kept safe. The ECFSPR is a registry holding data on CF patients throughout the European Union and some of the neighbouring countries over an extended period of time.
Why do we need a CF patient registry?
CF is a rare disease, which means that any particular single CF center, even the largest ones, only have experience with a limited number of patients. ECFSPR data are collected for lots of reasons: to increase the knowledge on CF, to determine clinical effectiveness of health care, for comparing and improving standards of care for CF patients, to support health care service planning and for research purposes. Collecting data from many countries and centers (in the latest report more than 20,000 patients from 16 countries) gives us the opportunity to compare between CF centers and countries, but also to prepare the landscape for possible clinical trials once new potential treatments arise for example to ensure a sufficient number of patients for research in rare complications, infections or specific genotypes.
Why should I as a patient participate?
Patient involvement is the key factor in the establishment of any patient registry. For the purpose of the above aims, we need as many patients in the registry as possible to 1) make sure that data are representative of the whole spectrum of the disease and 2) to have enough patients with e.g. a specific genotype, complication or infection to render research possible – research that may benefit you or other CF patients in the future. Probably we don’t need to convince you of the need to advance improvement in care and treatment and progression in research when good standards of care or treatment are lacking!
Which data are collected?
We collect so-called demographic data: current age, sex, genotype, age and symptoms at diagnosis; but also clinical data which are updated once a year e.g. lung function, weight, height, infections, treatment and complications. The data are collected using a common set of definitions and codes so that the data are comparable from country to country. The full list of data and definitions can be found here.
Is my (or my child’s) identity protected, and how?
We collect a set of semi-anonymous data – this means that we, at the ECFSPR, only know your month and year of birth (so we can calculate your current age), your sex and which center or country you belong to. Your center gives you a specific code, so they will be able to trace back to you in case we find problems with the data they entered, but only your center can track this code back to your name.
To protect your privacy even further, in our database all the centers have an EU-center number, not their name.
Thus it is not possible to get back to you without your permission.
If researchers request data from the registry they will either get anonymous data (tables, graphs etc) protected by center number or equivalently anonymised European aggregated data.
All storage and use of data in the ECFSPR is regulated by Danish, Italian and EU data protection legislation. The database in Milan, where the data of the ECFCSPR is stored, is of course protected by all means of data security of both hardware and software. If your data are collected initially in a national database, your data are stored there according to national laws and you can learn more about this from your centers. If your center is using our online registry software, your personal data are stored at the center and only the anonymous data described above are sent to us. All data are encrypted and password protected.
Which CF centers are participating?
There are two ways of participating in the registry. You can participate via a national registry collecting data from the centers and sending us all data from that country. This is the case for UK, France, Germany, Belgium, Denmark, The Netherlands, Italy, Czech Republik and Sweden. In these countries (almost) all centers participate.
In other countries, the centers use our online software and are thus linked to us directly. At the moment this is the case for Spain, Austria, Portugal, Switzerland, Slovenia, Greece and Latvia. New centers join us every week, so if you are in doubt whether your center is a part of the registry ask at your center or contact the ECFSPR Coordinator Jacqui van Rens email@example.com (link sends e-mail)
Who has access to the data? Who can make use of them?
Direct access to the data is allowed only to the CF centres. This means that only your doctor can enter and modify your data. The biostatisticians in charge of data management and data analysis can see the database but cannot modify your data and cannot identify you, because your identity is protected by the unique code known only to your center. In case the biostatisticians need some clarifications on the data, they send a query to the help-desk (the only one able to link the centre code to the centre name). The helpdesk will then contact the centre.
If your data are entered directly from a single center, the centers of a country can appoint a national coordinator who will then get access to anonymous data from all the centers in that country. This way your country will also have a national registry.
Researchers can apply for data for specific projects. The requests are reviewed by a scientific committee to ensure that your data are used according to the legislation and the aims of the registry as stated in the guidelines. The scientific committee includes a representative appointed by the CF Europe patient organization. If the permission is granted, the data will be analysed in cooperation between the researchers and our biostatisticians.
Where can I find the reports of the registry?
The annual reports from the ECFSPR can be found here. There is list of scientific articles that have made use of the data.
I am not in the registry. How do I get in?
First check with your local CF center. Maybe they are in the process of entering. In this case, have patience! Getting local data protection approval sometimes takes a very long time and after that the patients need to be informed and included. We at the ECFSPR regularly contact the centers that have not yet joined the registry, but we do not have contact details of all centers, especially in Eastern Europe, so you are welcome to send their contact details to us, and we will contact them. However, urging from the patients to join the registry sometimes speeds up the process.
For all enquiries, please contact the ECFSPR Coordinator Jacqui van Rens firstname.lastname@example.org (link sends e-mail)