Workshop 3 - "Presentation of the concept, definitions and terminology"


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Workshop 3 - Registries
"Presentation of the concept, definitions
and terminology"
Ulrike Pypops, CF Belgium

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Workshop 3 - "Presentation of the concept, definitions and terminology"

  1. 1. CONCEPT, DEFINITION ANDTERMINOLOGY OF REGISTRIESUlrike Pypops Lawyer at the Belgian CF Association Patient Representative of CF Europe in the ECFSPatient Registry Executive Committee Legal adviser of two hospital ethics committees(protocol review & ethics) Member of the Board of
  2. 2. CONCEPT & DEFINITION A patient registry is an  On-going, exhausive system of data collection  Of patients with the same disease  From a geographically defined population  Over an extended period of time≠ other databases: patient information management systems, ad hoc (observational) surveys, …
  3. 3. PURPOSE Increasing knowlegde on RD Determine clinical effectiveness of health care Supporting health care service planning Support research by pooling data in order to achieve a sufficient sample size for:  Epidomiological research  Clinical research  Surveillance of drugs used off-label  Post-marketing orphan drug surveillance
  4. 4. AND THE RD PATIENT? RD patient registries are only existing source of information on  the natural history of the disease e.g. sypmtoms, different patient profiles plus evolutions  epidemiology  optimal clinical management  social management  QOL outcomes
  5. 5. AND THE RD PATIENT?Patient registries on RD can improve the quality of care (for ex. guidelines/ standards of care) improve life expectancy better prepare for drug clinical trials if potential treatment arise assess “real” effectiveness of treatment outside controlled context of CT
  6. 6. SETTING UP A REGISTRY1. Designing and planning2. Data elements3. Data sources4. Data collection5. Ethics, data ownership and privacy6. Analysis & interpretation of data7. Reporting
  7. 7. PATIENT REGISTRY = SCIENTIFIC PROJECT Design (1) Creation (2) Objectives  Protocol Knowledge  Data collection Available stuff  Recording data Stakeholders  Controlling Timeschedual  Quality points Money Development→ Pilot study
  8. 8. PATIENT REGISTRY = SCIENTIFIC PROJECT Use (3)  Use of data  Update  Evaluation
  9. 9. ETHICS, PRIVACY AND DATA PROTECTIONEthics Respect for persons Beneficience Justice→ can lead to different conclusionsBut … has lead to practice (and legal requirement)of informed consent
  10. 10. INFORMED CONSENT: INFORMATION (1) Information on: Which info is gathered Why it’s gathered How it’s protected How to withdraw Who has access
  11. 11. INFORMED CONSENT: CONSENT (2) Consent to: Registry creation by compilation of patient information Research purpose(s) Use of registry data Etc.
  12. 12. PRIVACY Personal data: any information concerning an identified or identifiable person Sensitive data (for ex. concerning health):In principle, such data cannot be processed.Derogation is tolerated under very specific circumstances.These circumstances include the data subject’s explicitconsent to process sensitive data→ Directive 95/46/EC (the data protection Directive)→ Compliance with national/local protection legislation
  13. 13. PRIVACY Protecting your identity?= Setting “defence” mechanisms1. Anonymous data2. Coded data (codes which do not reflect your initials and/ or day of birth) What with ultra RD’s? Or with ultra rare mutations for a in RD’s?
  14. 14. DATA PROTECTION Securing the access at the entrance point Securing the access at the storage center Securing cross referencing of data Securing the access of “demanding” parties  Who gets access to which information?  Securing/ limiting the 3rd party use of data → is it beneficient to the patient?
  15. 15. PITFALLS Incomplete cohort Poor representativity Bad precision Improperly observations Pollution and errors Inaccurate measure Misunderstanding Loss of the work Unethical work Incomplete data
  16. 16. PATIENT’S CONRIBUTION Patients and their families bring knowlegde and experience about daily life and their illness to the physician/ researcher The physician/ researcher adds epidemiological and clinical data If you collect all this you have a firm base for a patient registry Without patients … no patient registry!
  17. 17. ROLE OF PATIENT ORGANISATIONS Design Creation  Idea  Participation in  Purposes management  Recruitment  Communicate Use Evaluation  Family help & info  Improve diagnosis  Social policy
  18. 18. WANT TO KNOW MORE? Eurordis Fact Sheet – RD patient registries Registries for evaluating patient outcomes : a users guide, Agency of HealthCare Research and Quality, September 2010, 367 pages Directive 95/46/EC of the European Parliamentand of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data