title: The European Cystic Fibrosis Society Patient Registry: valuable lessons learned on how to sustain a disease registry.
abstract: BACKGROUND
  Disease registries have the invaluable potential to provide an insight into the natural history of the disease under investigation, to provide useful information (e.g. through health indicators) for planning health care services and to identify suitable groups of patients for clinical trials enrolment. However, the establishment and maintenance of disease registries is a burdensome initiative from economical and organisational points of view and experience sharing on registries management is important to avoid waste of resources. The aim of this paper is to discuss the problems embedded in the institution and management of an international disease registry to warn against common mistakes that can derail the best of intentions: we share the experience of the European Cystic Fibrosis Society Patient Registry, which collects data on almost 30,000 patients from 23 countries.
  
  
  METHODS
  We discuss the major problems that researchers often encounter in the creation and management of disease registries: definition of the aims the registry has to reach, definition of the criteria for patients referral to the registry, definition of the information to record, set up of a data quality process, handling of missing data, maintenance of data confidentiality, regulation of data use and dissemination of research results.
  
  
  RESULTS
  We give examples on how many crucial aspects were solved by the European Cystic Fibrosis Society Patient Registry regarding objectives, inclusion criteria and variables definition, data management, data quality controls, missing data handling, confidentiality maintenance, data use and results dissemination.
  
  
  CONCLUSIONS
  We suggest an extensive literature research and discussions in working groups with different stake holders, including patient representatives, on the objectives, inclusion criteria and the information to record. We propose to pilot the recording of few variables and test the applicability of their definition first. The use of a shared electronic platform for data collection that automatically computes derived variables, and automatically performs basic data quality controls is a good data management practice, that also helps in reducing missing data. We found crucial for success the collaboration with existing national and international registries, cystic fibrosis organisations and patients' associations.
authors.forename: Laura
authors.initials: L
authors.lastname: Viviani
authors.affiliation: Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy. anna.zolin@unimi.it.
authors.forename: Anna
authors.initials: A
authors.lastname: Zolin
authors.forename: Anil
authors.initials: A
authors.lastname: Mehta
authors.forename: Hanne Vebert
authors.initials: HV
authors.lastname: Olesen
mesh_terms: D003550:Cystic Fibrosis / Q000453:epidemiology*; D003625:Data Collection; D005060:Europe / Q000453:epidemiology; D006801:Humans; D012042:Registries