Cystic Fibrosis Center Program

TITLE of STUDY: The Cystic Fibrosis Registry 1. Background: The Cystic Fibrosis (CF) Registry was established in 1966 as a means to monitor important trends in the CF population and to improve care and treatment and report survival statistics. Information on over 20,000 patients with CF in the USA is collected annually from all CF Foundation accredited CF Care, Teaching and Research Centers. Data from this registry has been essential towards the care and progress that has been seen in CF and the improved survival over the years. The University of Kentucky CF Center has participated in the Registry since its inception in the 60’s. All cystic fibrosis patients seen for at our Center are invited to participate. Written consent is obtained for the patients or caregivers before any information is entered into the registy. The patient information is collected electronically, on a secure website that is managed by the CF Foundation. 2. Objectives: The CF Patient Registry is used by both clinicians and researchers to better understand CF trends and to improve care of individuals with CF. Each year, the data in the Registry is analyzed and an annual report of CF health trends is created. Using this information, CF clinicians can address quality improvement initiatives, and examine dynamic health care issues, including nutritional status, infection control, pulmonary treatment and other issues rapidly and effectively. The Registry also has played an important role in directing clinical care and in the design of clinical research studies. Researchers may request information from the CF Registry (without individual patient identifiers) through the CF Registry Committee. This committee evaluates the scientific merit of data requests from respected scholars who specialize in treating people with CF. 3. Study Design: All CF Care Centers are mandated to participate in the Registry if they are accredited as a Center. Care centers enter information such as state of residence, age, social security number, height, weight, pulmonary function, nutritional status, CF gene markers, CF-related complication, etc. and treatments (i.e. medications and other therapies) to the CF Foundation via the Registry. This information is transmitted electronically to the CF Foundation. The CF Foundation maintains this information in a comprehensive, secure database that is protected with passwords and encryption codes. 4. Study Population: All CF patients who receive their CF Care at the University of Kentucky CF Center will be asked to participate. This will include children who are wards of the State and prisoners. A combined consent / assent form that has been approved by the University of Kentucky IRB will be signed by the appropriate person prior to the patients’ enrollment in the CF Registry. Participation in the CF Registry is entirely voluntary and patients who do not want to participate will continue to receive the usual CF standard of care at the University of Kentucky. 5. Study Recruitment Methods: Patients will be approached during routine clinic visits or hospitalizations for CF. 6. Research Procedures: Data that is collected at routine clinic visits or during a hospitalization will be recorded in the database. There are no additional tests or procedures required by the CF Registry other than that which is usual in providing care for CF patients. 7. Potential Risks: None. 8. Safety Precautions: No potential risks anticipated. Complete patient confidentiality will be maintained by the CF Center personnel and by the CF Foundation that maintains the secure website. 9. Benefit vs. Risk: No direct benefit to the individual patients is anticipated. Monitoring disease trend in CF and the effect of new treatment options that may be found by this large database may benefit the entire CF population. 10. Available Alternative Treatment(s): None. Patients or their families who elect not to participate will continue to receive the routine, standard of care during clinic visits and hospitalizations. 11. Research Materials, Records and Confidentiality: Data from the patient’s medical records will be entered in the secure web based data form and transmitted to the CF Foundation. Both the CF Registry Committee and the other researcher’s with permission from the CF Registry Committee will use information for data analysis and share this with the CF Community. All patient identifiers will remain confidential. 12. Incentives and Research Related Costs: There will be no cost to the patient, their families or third party payers for participation in the CF Registry. 13. Data Safety and Monitoring for NIH Sponsored Research: Not applicable. 14. Off-site Research: Not applicable.