1. European Cooperative Network for Research, Diagnosis and Therapy of Parkinson´s Disease EuroPa MIDTERM REVIEW WORK PACKAGE 3 Patient Registry

2. MEMBERS OF THE REGISTRY GROUP MEMBERS OF THE REGISTRY GROUP PARTNER 13: Werner Poewe (WP3 Leader, Innsbruck) Cecilia Peralta (WP3 Project Manager, Innsbruck ) Cecilia Peralta (WP3 Project Manager, Innsbruck ) PARTNER 1: Wolfgang Oertel (Coordinator, WP1, Marburg) Regina Wick (Senior Project Manager, WP1, Marburg) Regina Wick (Senior Project Manager, WP1, Marburg) PARTNER 8: Cristina Sampaio (Contractor, Lisbon) PARTNER 3: Olivier Rascol (WP4 Leader, Toulouse) PARTNER 9: Paolo Barone (Contractor, Naples) PARTNER 5: Markus Stoll (CIO, Berlin, WP2)

3. MAIN TASKS RESPONSABILITIES Establishment of an European registry of Parkinson´s Disease Establishment of an European registry of Parkinson´s Disease patients patients Development of the Minimal Data Set (MDS) Development of the Minimal Data Set (MDS) Incorporation of existing registries Incorporation of existing registries Oversight of patient entry (in cooperation with all EuroPa Oversight of patient entry (in cooperation with all EuroPa members members Quality control of data entry Quality control of data entry

4. MILESTONES WP3

5. STRUCTURE OF MINIMAL DATA SET Part A: Patient Data Part B: Clinical Data Part C: Drug History Part D: Current Treatment Part E: Clinical Trial History

6. MINIMAL DATA SET

11. CENTER STATUS

12. BREAKDOWN OF PATIENTS ACCORDING CENTERS N= 513

13. BREAKDOWN OF PATIENTS ENTERED ELECTRONICALLY Marburg96 Tel Aviv 37 London74 Groningen20 Prague18 Naples79 N= 324

14. WEEKLY RATE OF PATIENT ENTRY 400010004000 Month 18 Month 30 Month 36 Month 18 Month 30 Month 36 mean weekly entry of 3 patients 7 centers mean weekly entry of 3 patients all centers mean weekly entry of 5 patients all centers 397 1909 2773 4357 1008 1584 2640

15. REGISTRY ENTRY Activate all centers Activate all centers Switch to electronical entry for all centres Switch to electronical entry for all centres Redefine sampling procedure Redefine sampling procedure Approve Registry Policy Approve Registry Policy Create National Nodes Create National Nodes MEASURES TO INCREASE ENTRY RATE

16. Define a centre-specific random sampling procedure Define a centre-specific random sampling procedure Based on the outpatient population seen over April- May- June 2003 in each centre, estimate a reasonable weekly entry rate (%) and sample size Based on the outpatient population seen over April- May- June 2003 in each centre, estimate a reasonable weekly entry rate (%) and sample size SAMPLING PROCEDURE - New version-

17. WEEKLY RATE SAMPLE SIZE CENTRE WEEKLY OUTPATIENT SAMPLING RATE RATE average 3 months (25%) RATE average 3 months (25%) Marburg 20 5 London 15 4 Naples 24 6 Innsbruck 23 5 Prague 30 7 Toulouse 30 7 Lisbon 22 5 Tel Aviv 10 3 Groningen 10 3 Barcelona 41 10 Lund 12 3 TOTAL 237 58 (5 mean)

18. SAMPLING PROCEDURE - New Version- SAMPLING PROCEDURE - New Version- Each centre defines its own random sampling Each centre defines its own random sampling procedure procedure Weekly entry rate of the random out-patient Weekly entry rate of the random out-patient sample will be set at 25% of the weekly outpatient sample will be set at 25% of the weekly outpatient population population Patients entered outside the sampling procedure Patients entered outside the sampling procedure will be coded separately will be coded separately

20. ALLOCATIONS OF HUMAN RESOURCES 20 of 48 person months funded have been used by May 2003 by May 2003 24 of 86 person months for permanent staff have been 24 of 86 person months for permanent staff have been used by May 2003 used by May 2003 Work Package 3

21. WP 3 SUMMARY 7 out of 11 centres are actively recruiting patients 7 out of 11 centres are actively recruiting patients 6 centres have started electronical data entry 6 centres have started electronical data entry 5 centres are waiting for data/ethic committee approval 5 centres are waiting for data/ethic committee approval Minimal Data Set was developed and updated Minimal Data Set was developed and updated First 1000 patients will be achieved by month 30 First 1000 patients will be achieved by month 30 Centre specific sampling procedure defined Centre specific sampling procedure defined Final version of the Registry Policy mailed to all centres Final version of the Registry Policy mailed to all centres