Registry FAQ's

What is a Registry?

A medical Registry is a central resource cataloguing all of the patients who have a specific medical condition within a geographic area, usually a country. The data collected is standard for all patients and can be used to show comparisons of treatments and outcomes resulting from those treatments for that condition.

The purpose of the CFRI is to keep relevant medical records of each patient in a central place (computer). By keeping them on a computer one can quickly find out the number of patients with cystic fibrosis in Ireland; how many are born with CF each year, and what medications each patient is taking. That information will help in planning for hospital resources such as doctors, nurses and beds.

It can also be used to create treatment guidelines for all patients. Research projects will examine the information in the CFRI and show which treatment strategies are the most successful. These strategies can then be generalised for the whole CF population in the form of guidelines. This will eventually contribute to a higher standard of treatment for everyone.

In the case of the CFRI, the information will be collected through the internet and held in a secure (encrypted) database on a private server at the internet service provider.

How will the information be collected and put into the computer system?

Each patient will be asked to sign a Consent Form after they have read the Registry Information Booklet and discussed the Registry with a Clinical Research Associate, and doctors and nurses at their specialist clinics. Once this happens, a copy of the signed Consent Form will be filed at the CFRI office. A Clinical Research Associate will then go to the hospital clinic where the patient's records are kept and read the medical chart at the hospital and then transcribe the information from the chart into the computer system on a lap-top computer. This will happen annually after enrolment.

How will the information in the Registry be used?

Each consultant will be able to see his own patients' records and these will be all on one system, so s/he will be able to get summaries of his/her practice over the last 12 months. For instance, one may want to know how many patients were treated in hospital once, twice, or several times in the last year. One may also ask, 'what types of infections did patients suffer from?'. The answers will be found in the CFRI (in a report form) as well as what antibiotics were used to treat those infections.

The CFRI will record the treatments that have been given as prescribed by the doctors, nurses, physiotherapists or dieticians. The CFRI will not recommend any drug treatments or other treatments per se, but treatment history will be catalogued in the CFRI and recommendations may evolve from research done using CFRI information.

Who will participate in the CFRI?

It is hoped that all patients with cystic fibrosis living in Ireland will participate in the CFRI. The quality of the information that comes out of the Registry will be enhanced by greater numbers of people participating.

If a person attends both a Specialist CF Centre and a regional centre, will they have two sets of information in the Registry?

No. Each person will have only one set of information in the Registry. Typically, the information forms will be completed once a year at the Specialist CF Centre. The forms will be collected from the Specialist Centre and added to the CFRI by the Director. This information will be available to a regional consultant if the patient attends that consultant, but in a "read-only" format.

Is every hospital in Ireland that treats CF patients taking part in the Registry?

It is hoped that every hospital that treats CF patients will take part. However, each hospital must approve of the CFRI through their Ethics Committee, before taking part in the CFRI.
Up to 2008, all CF Specialist Centre hospitals have given ethical approval for the CFRI.

Do individual hospitals have the option to not take part?

Yes. An individual hospital's Ethics Committee may decide not to take part.

Who is responsible for the Registry to ensure that it is not misused?

The Executive Council is responsible for the creation and maintenance of the CFRI through the Chief Executive. Several processes are in place so that the highest confidentiality and data security methods are maintained. A sub-committee of the CFRI is charged with reviewing procedures.

Each patient may have access to their own Registry records through their CF consultant or GP.

Data protection regulations also suggest that a person who is not a health professional should not disclose health information without first consulting an individual's own doctor. Thus, it is preferable for the Chief Executive to give a copy of Registry information to a doctor nominated by the PWCF so that the health professional will put the information into context for the patient during a consultation.

What kind of information will be stored in the Registry about each patient?

There will be two sections of information stored about each patient. The first section is about diagnosis: at what age CF was diagnosed and the presenting symptoms. For example, it may have been at birth or shortly afterwards, or it may have been later when the person suffered from repetitive digestive or respiratory problems.

The second section of information will be an annual update. This will cover all the infections and treatments over the previous twelve months.

If personal records are available to the consultant, does that include his team of junior doctors, CF nurses, physiotherapists, dieticians, etc.?

This will be decided by each individual consultant. A special access "user name" and "password" will be assigned to each consultant taking part. He may submit a request to the Executive Council that separate user names and passwords be assigned to named staff. However, when doctors rotate away from a CF service, their names will be withdrawn from the permitted usage list and their passwords cancelled.

If a person is on the Registry before they turn 18 years of age, will they be asked about continuing on the Registry after they turn 18?

Yes. PWCF will be asked to sign a Consent Form as an adult.

What are the benefits of the Registry?

After a few years of gathering information, doctors and scientists will be able to analyse the data in the Registry in order to predict the long term outlook for Irish patients with cystic fibrosis.

They will also be able to compare treatments in Ireland with treatments in other countries.

In the future patients may benefit from this medical research. Such benefits include the possibility that one's condition may improve through assessment of current practices and that the CFRI may assist in the development of new therapies.

What costs are involved for patient participation?

There are no costs for the patient attached to participation in the Cystic Fibrosis Registry of Ireland.

How is patient confidentiality protected?

Participation in the CFRI will be treated as confidential and any personal records or results relating to the CFRI shall not be disclosed to any third party other than one's consultant doctor.

Information from the CFRI may be used for the purposes of medical and/or social research only under strict conditions approved by the Executive Council and that information will be anonymous at all times.

All information will be kept in accordance with guidelines issued by the Data Protection Commission and no personal information will be given to any person or agency at any time.

What kind of "new information" might come to light because of the Registry? How will I find out about it?

One possible type of new information is the following: it might be that new antibiotics will come onto the market in coming years. It is important that doctors know as soon as possible whether a new product is effective against the bacteria that affect CF patients. If all the CF patient records for those who are taking the new product are in 'one filing cabinet', there is a good chance of knowing sooner the effectiveness of the new product. As soon as an analysis takes place on a new product the doctors will be informed and they will review this new information with the patient.

Who will be allowed into the system to retrieve information?

The Chief Executive and the Clinical Research Associates will be able to see everyone's records in the system. No one other than the Chief Executive and the CRA’s will be allowed to see everyone's personal information. Organisations such as the Cystic Fibrosis Association of Ireland may request reports from the Registry which may assist in making representations to the HSE for more resources for CF patients. But all information in reports such as these will be anonymous.

How will the Executive Council decide on who can look at the information in the Registry?

If a medical researcher wishes to study the information on the CFRI, s/he must submit a research proposal to the Executive Council. This committee will judge each proposal separately. Only anonymous data will be released for research projects. No personal data will ever be released to researchers.

No funding for research projects is available through the Executive Council.

Will anyone outside of Ireland see my data?

No personal data will ever be disclosed to researchers either inside, or outside of Ireland.

There are plans to create a European CF Registry which will act as a research tool in the same way as the CFRI. This means that anonymous data from all European participant countries will be merged together in one large database. (For example, all CF children across Europe who are 5 years old might be compared for growth and infection occurrences.) There may also be international studies which will request data from the CFRI. The purpose of these studies is to find out if patients in some countries are receiving better treatment than those in other countries. This will eventually lead to best-practice guidelines so that more people will benefit from successful treatment.

The Executive Council will ensure that no personal data identifiers will be merged with information outside of this country.

What advantages are there for me if I participate in the Registry?

It has been shown in other countries that the overall care of CF patients improves once all their medical information is in one system (i.e., a Registry). Treatments of all participants can be compared with others throughout the country and this analysis may reveal areas for improvement in overall care for all patients.

What disadvantages are there for me if I do not participate in the Registry?

There are probably no obvious disadvantages for one single person to refuse to participate. It may be more useful to look at it from the other perspective: if everyone participates, everyone gains. Participation is voluntary however, and one may withdraw from the CFRI at any time.

How do I withdraw from the Registry?

Participation in the Registry is voluntary.
Everyone is entitled to receive a copy of their signed Consent Form.

Anyone enrolled in the Registry has the right to ask any questions concerning the CFRI at any time.

Anyone may discontinue their participation in the CFRI at any time without loss of benefits to which they are otherwise entitled.

If someone would like their information removed from the CFRI, they will be given copies of the information that is removed from the CFRI and assured by an IT specialist that the information has been deleted from the CFRI (computer system).

Who can answer further questions for me?

The consultants and CF Specialist Nurses at each centre can answer most questions about the Registry. If you have further questions, please contact the Chief Executive or one of the Clinical Research Associates.