Titel

1

European Cooperative Network for Research,
Diagnosis and Therapy of Parkinsons
Disease EuroPa MIDTERM REVIEW WORK PACKAGE
3 Patient Registry

2
MEMBERS OF THE REGISTRY GROUP

PARTNER 13 Werner Poewe (WP3 Leader,
Innsbruck) Cecilia Peralta (WP3 Project
Manager, Innsbruck) PARTNER 1 Wolfgang Oertel
(Coordinator, 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
  Parkinsons Disease
• patients
• Development of the Minimal Data Set (MDS)
• Incorporation of existing registries
• Oversight of patient entry (in cooperation with
  all EuroPa
• members
• Quality control of data entry

4
MILESTONES WP3

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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
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MINIMAL DATA SET

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MINIMAL DATA SET

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MINIMAL DATA SET

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MINIMAL DATA SET

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MINIMAL DATA SET

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CENTER STATUS




























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BREAKDOWN OF PATIENTS ACCORDING CENTERS

N 513
13
BREAKDOWN OF PATIENTS ENTERED ELECTRONICALLY

Naples 79
Marburg 96
Prague 18

Groningen 20
Tel Aviv 37
N 324
London 74
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WEEKLY RATE OF PATIENT ENTRY
4000 1000 400 0
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
4357
2640
2773
1584

1909
1008
397

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REGISTRY ENTRY

MEASURES TO INCREASE ENTRY RATE

• Activate all centers
• Switch to electronical entry for all centres
• Redefine sampling procedure
• Approve Registry Policy
• Create National Nodes

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SAMPLING PROCEDURE- New version-

• 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

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WEEKLY RATESAMPLE SIZE

CENTRE WEEKLY OUTPATIENT
SAMPLING RATE
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)




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SAMPLING PROCEDURE- New Version-

• Each centre defines its own random sampling
• procedure
• Weekly entry rate of the random out-patient
• sample will be set at 25 of the weekly
  outpatient
• population
• Patients entered outside the sampling procedure
  
• will be coded separately

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20
ALLOCATIONS OF HUMAN RESOURCES

Work Package 3

• 20 of 48 person months funded have been used
• by May 2003
• 24 of 86 person months for permanent staff have
  been
• used by May 2003

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WP 3 SUMMARY

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