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

EuroPaEuroPaMIDTERM REVIEWMIDTERM REVIEW

WORK PACKAGE 3WORK PACKAGE 3Patient RegistryPatient Registry

MEMBERS OF THE REGISTRY MEMBERS OF THE REGISTRY GROUPGROUP

PARTNER 13:PARTNER 13: Werner Poewe (WP3 Leader, Innsbruck)Werner Poewe (WP3 Leader, Innsbruck)

Cecilia Peralta (WP3 Project Manager, InnsbruckCecilia Peralta (WP3 Project Manager, Innsbruck))

PARTNER 1:PARTNER 1: Wolfgang Oertel (Coordinator, WP1, Marburg)Wolfgang Oertel (Coordinator, WP1, Marburg)

Regina Wick (Senior Project Manager, WP1, Marburg)Regina Wick (Senior Project Manager, WP1, Marburg)

PARTNER 8:PARTNER 8: Cristina Sampaio (Contractor, Lisbon)Cristina Sampaio (Contractor, Lisbon)

PARTNER 3:PARTNER 3: Olivier Rascol (WP4 Leader, Toulouse)Olivier Rascol (WP4 Leader, Toulouse)

PARTNER 9:PARTNER 9: Paolo Barone (Contractor, Naples)Paolo Barone (Contractor, Naples)

PARTNER 5:PARTNER 5: Markus Stoll (CIO, Berlin, WP2)Markus Stoll (CIO, Berlin, WP2)

MAIN TASKS MAIN TASKS RESPONSABILITIESRESPONSABILITIES

Establishment of an European registry of Parkinson´s Disease Establishment of an European registry of Parkinson´s Disease

patientspatients

Development of the Minimal Data Set (MDS)Development of the Minimal Data Set (MDS)

Incorporation of existing registriesIncorporation of existing registries

Oversight of patient entry (in cooperation with all EuroPa Oversight of patient entry (in cooperation with all EuroPa

membersmembers

Quality control of data entryQuality control of data entry

MILESTONES WP3MILESTONES WP3

Time Due Completed

Milestones Ongoing

Minimal Data Set

month 12

Start of Data Entry

month 18

Registry Policy

month 6

First 1000 patients

month 30

First 4000 patients

month 36

STRUCTURE OF STRUCTURE OF MINIMAL DATA SET MINIMAL DATA SET

Part A:Part A: Patient Data Patient Data

Part B:Part B: Clinical Data Clinical Data

Part C:Part C: Drug History Drug History

Part D:Part D: Current Treatment Current Treatment

Part E:Part E: Clinical Trial History Clinical Trial History

MINIMAL DATA SETB Clinical Data

As assessed at time of current examination

B1.

Hoehn and Yahr (H&Y) stage

For Patients on drug therapy use ON value

B2.UPDRS II

Use historical information of the previous week, regarding overallperformance (ON and OFF combined).

B3. UPDRS III

For Patients on drug therapy use ON value

For items B4 through B19 in case of any doubt or lack of information,answer NO.For definitions and diagnostic criteria click HELP.

MINIMAL DATA SET

Yes No

B4. Motorfluctuations

If YES specify:B4.1 wearing-off

B4.2 ON-OFF fluctuations

B5. ON-period dyskinesias

If YES specify:disabling

B6. OFF-period dystonia

If YES specify:disabling

B7. Freezing of gait

MINIMAL DATA SET

Yes No

B9. Dementia

B10. Psychosis

B11. Depressive disorder

If YES specify:B11.1 past

B11.2 current

B12. Orthostatic hypotension

B13. Male erectile dysfunction

MINIMAL DATA SET

Yes No

B14. Urinary incontinence

B15. Chronic constipation

B16. Sleep disorders

If YES specify:B16.1 insomnia

Rate YES in case of subjective complaint of poor sleepirrespective of cause.

B16.2 daytime sleepiness

Rate YES in case of subjective complaint or caregiverobservation of daytime sleepiness/sedation.

Yes No

B16.3 REM behaviour disorder

YES only in accordance with the ICSDcriteria (at least Minimal Criteria B plus C).

MINIMAL DATA SET Yes No

B17. PD related pain

Rate YES with any score above zero on item 17 ofUPDRS II.

B18. Currently on anti-parkinsonian medication

B19. Deep brain surgery

B20. First degree relative with PD or tremor

If YES specify:parent

sibling

B21. DNA sample available

ActivelyRecruiting

Entering intotheelectronicaldatabase

Ethicalapproval/dataprotectionapproval

Waitingfor dataprotectionapproval

Recruitmentnot started

Marburg x x xLondon x x xGroningen x x xInnsbruck x xPrague x x xNaples x x xTel Aviv x x xBarcelona x xLund x xLisbon x X

Toulouse x x

CENTER STATUSCENTER STATUS

BREAKDOWN OF PATIENTS BREAKDOWN OF PATIENTS ACCORDING CENTERSACCORDING CENTERS

0102030405060708090

100

Mar

burg

Nap

les

Inns

bruc

k

Lond

on

Gro

ning

en

Tel A

viv

Pra

gue

Marburg

Naples

Innsbruck

London

Groningen

Tel Aviv

Prague

N= 513N= 513

BREAKDOWN OF PATIENTS BREAKDOWN OF PATIENTS ENTERED ELECTRONICALLYENTERED ELECTRONICALLY

Marburg

Tel Aviv

London

Groningen

Prague

Naples

MarburgMarburg9696

Tel AvivTel Aviv3737

LondonLondon7474

GroningenGroningen2020

PraguePrague1818

NaplesNaples7979

N= 324 N= 324

WEEKLY RATE OF PATIENT ENTRYWEEKLY RATE OF PATIENT ENTRY

40004000

10001000

400400

0 0

Month 18 Month 30 Month 36Month 18 Month 30 Month 36

mean weekly entry of 3 patients 7 centersmean weekly entry of 3 patients 7 centersmean weekly entry of 3 patients all centersmean weekly entry of 3 patients all centersmean weekly entry of 5 patients all centersmean weekly entry of 5 patients all centers

397

19091909

2773277343574357

1008100815841584

26402640

REGISTRY ENTRYREGISTRY ENTRY

Activate all centers Activate all centers

Switch to electronical entry for all centresSwitch to electronical entry for all centres

Redefine sampling procedureRedefine sampling procedure

Approve Registry PolicyApprove Registry Policy

Create National NodesCreate National Nodes

MEASURES TO INCREASE ENTRY RATEMEASURES TO INCREASE ENTRY RATE

Define a centre-specific random sampling Define a centre-specific random sampling procedureprocedure

Based on the outpatient population seen over Based on the outpatient population seen over April- May- June 2003 in each centre, estimate a April- May- June 2003 in each centre, estimate a reasonable weekly entry rate (%) and sample size reasonable weekly entry rate (%) and sample size

SAMPLING PROCEDURESAMPLING PROCEDURE- New version-- New version-

WEEKLY RATEWEEKLY RATESAMPLE SIZESAMPLE SIZE

CENTRE WEEKLY OUTPATIENT SAMPLING RATE CENTRE WEEKLY OUTPATIENT SAMPLING RATE RATE average 3 months (25%)RATE average 3 months (25%)

MarburgMarburg 2020 5 5

LondonLondon 1515 4 4

NaplesNaples 2424 6 6

InnsbruckInnsbruck 2323 5 5

PraguePrague 3030 7 7

ToulouseToulouse 3030 7 7

LisbonLisbon 2222 5 5

Tel AvivTel Aviv 10 10 3 3

GroningenGroningen 10 10 3 3

BarcelonaBarcelona 41 41 10 10

Lund Lund 12 12 3 3

TOTALTOTAL 237237 58 (5 mean) 58 (5 mean)

SAMPLING PROCEDURESAMPLING PROCEDURE- New Version-- New Version-

EachEach centre defines its own random sampling centre defines its own random sampling procedureprocedure

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 populationpopulation

Patients entered outside the sampling procedure Patients entered outside the sampling procedure will be coded separatelywill be coded separately

Minimal Data Set

A Patient Data

A1. Patient randomly selected according to Sampling Procedure?

A2. Patient recruited as out-patient yes no

A3. Date of birth

A4. Gender

A5. Date of examination

A6. Diagnosis:

Please enter patients diagnosed with iPD only. The other options are given in case the diagnosis is revisedat a later date.

iPDMSA

CBD

PSP

drug-induced

parkinsonism

others:

A7. Time of symptom onset:If mont not known, enter NK for month.

female male

mm-yyyy

dd-mm-yyyy

yes no

ALLOCATIONS OF HUMAN ALLOCATIONS OF HUMAN RESOURCESRESOURCES

20 of 48 person months funded have been used 20 of 48 person months funded have been used

by May 2003by May 2003

24 of 86 person months for permanent staff have been24 of 86 person months for permanent staff have been

used by May 2003used by May 2003

Work Package 3

WP 3 SUMMARY

7 out of 11 centres are actively recruiting patients7 out of 11 centres are actively recruiting patients

6 centres have started electronical data entry6 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 updatedMinimal Data Set was developed and updated

First 1000 patients will be achieved by month 30First 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 centresFinal version of the Registry Policy mailed to all centres