European Cooperative Network for European Cooperative Network for Research, Diagnosis and Therapy of Parkinson´s DiseaseResearch, Diagnosis and Therapy of Parkinson´s Disease

EuroPa Plenary EuroPa Plenary MeetingMeeting

WORK PACKAGE 3WORK PACKAGE 3 - Patient Registry -- Patient Registry -

- MAIN TASKS -- MAIN TASKS -

√√ Establishment of an european Registry of Parkinson´s Establishment of an european Registry of Parkinson´s Disease patientsDisease patients

√√ Development of the Minimal Data Set (MDS) and Development of the Minimal Data Set (MDS) and Sampling Procedure for patient recruitmentSampling Procedure for patient recruitment

√√ Participation in the database development and test-runParticipation in the database development and test-run

√ Keep track of the weekly entry rate and follow up visitsKeep track of the weekly entry rate and follow up visits

√ Quality control of medical data entryQuality control of medical data entry

-- MILESTONES -MILESTONES -

Time Due

(months)

Completed milestones

Ongoing

milestones

1st period

Start of data entry

18 √√

2 nd period

First 1000 patients

30 √√

First 4000 patients

36 √√

- DELIVERABLES -- DELIVERABLES -MONTHMONTH NATURENATURE CURRENT STATUSCURRENT STATUS

1 1 stst meeting of the meeting of the Registry groupRegistry group

22 OtherOther CC meeting 01/02CC meeting 01/02

Registry policyRegistry policy 66 OtherOther Discussed at SC meeting 07/02Discussed at SC meeting 07/02

Discussed at SC meeting 07/03Discussed at SC meeting 07/03

Approved 08/03Approved 08/03

Minimal Data SetMinimal Data Set 1212 PublicPublic Finalized 12/03Finalized 12/03

Updated 09/03Updated 09/03

2 2 nd nd meeting of the meeting of the Registry groupRegistry group

1818 OtherOther Conference call 06/03Conference call 06/03

Functioning user´s-Functioning user´s-interfaceinterface

1818 OtherOther Available since 05/03Available since 05/03

- CENTER STATUS -- CENTER STATUS - Actively

recruitingWeb

data

entry

Ethical Committee approval

Data Protection approval

Follow up visits on going

Marburg √√ √√ √√ √√ √√

London √√ √√ √√ √√ √√

Groningen √√ √√ no no no

Innsbruck √√ √√ √√ √√ √√

Barcelona √√ √√ √√ √√ no

Lisbon √√ √√ √√ √√ no

Toulouse √√ √√ not needed √√ no

Tel Aviv √√ √√ not needed √√ no

Naples √√ √√ √√ √√ no

Prague √√ √√ √√ no no

Lund not active not active not active not active not active

- REGISTRY ENTRY OVER TIME -- REGISTRY ENTRY OVER TIME -

planned

obtained

Milestones (months)Milestones (months)

PatientsPatients

0 18 30 34 36

4000

3000

2000

1000

500 397397

1610161017761776

- BREAKDOWN OF CENTRES- BREAKDOWN OF CENTRES --

N=1776N=1776

Innsbruck(277)

Marburg(237)

Naples(211)

London(205)

Toulouse(183)

Prague(185)

Barcelona(123)

Lisbon(116)

Groningen(119)

Tel Aviv(120)

- RANDOM SAMPLE -- RANDOM SAMPLE -

N= 1447N= 1447

Innsbruck(232)

Marburg(127)

Naples(117)

London(184)

Toulouse(182)

Prague(165)

Barcelona(122)

Lisbon(107)

Groningen(116)

Tel Aviv(95)

- FIRST DATABASE QUERY -- FIRST DATABASE QUERY -

√√ Test the functionality of the Recruitment ToolTest the functionality of the Recruitment Tool

√√ Check-up of the completeness of all FormsCheck-up of the completeness of all Forms

√√ Comparability of the results among centresComparability of the results among centres

√√ Medical data quality controlMedical data quality control

√√ Contribution to the future exploitation of the RegistryContribution to the future exploitation of the Registry

OBJECTIVESOBJECTIVES

- QUERY PATIENTS -- QUERY PATIENTS -

216

179

247

99 MarburgMarburg

GroningenGroningen

LondonLondon

InnsbruckInnsbruck

- HOEHN & YAHR -- HOEHN & YAHR -

H&Y

1 – 1,5

H&Y

2 – 2,5

H&Y

3 - 4

H&Y

5

Marburg 34 (15%)

40 (18%)

60 (27%)

41 (18%)

22 (10%)

13 (6%)

6 (2%)

London 9 (5%)

14 (7%)

14 (7%)

31 (17%)

65 (36%)

20 (11%)

2 (1%)

Innsbruck 25 (10%)

2 (0,8%)

96 (38%)

39 (15%)

61 (24%)

22 (8%)

2 (0,8%)

Groningen 7 (7%)

10 (10%)

36 (36%)

24 (24%)

16 (16%)

6 (6%)

0 (0%)

-- DEMENTIA - PSYCHOSIS DEMENTIA - PSYCHOSIS DEPRESSIONDEPRESSION - -

DEMENTIA PSYCHOSIS DEPRESSION

Marburg 5 (2%) 22 (10%) 15 (7%)

London 26 (14%) 40 (22%) 17 (9%)

Innsbruck 35 (14%) 32 (13%) 74 (29%)

Groningen 20 (20%) 8 (8%) 19 (19%)

- PAIN - SLEEP DISORDERS -- PAIN - SLEEP DISORDERS -

PAINPAIN SLEEP SLEEP DISORDERSDISORDERS

Marburg 31 (14 %) 70 (32%)

London 91 (50%) 128 (71%)

Innsbruck 114 (46%) 179 (72%)

Groningen 24 (24%) 66 (66%)

- PRELIMINARY CONCLUSIONS -- PRELIMINARY CONCLUSIONS -

√ Marked heterogeneity of clinical features among centres

* Selection bias

* Geographical differences

* „Interrater reliability“

- WP3 PROPOSALS -- WP3 PROPOSALS -

√ Check the validity of the databaseCheck the validity of the database

√√ Implement the export tool Implement the export tool

√√ Define protocols for common database queriesDefine protocols for common database queries