Cost-of-Care and Quality of Life

of Patients with Parkinson´s Disease

in Europe

• Study Outline

• Handling of study documents

• Monitoring process

• Study status and timelines

Study on the cost-of-care and health-related quality of life

Determination of

-health care utilization

-health-related quality of life

Objectives

Direct costs Indirect costs medical Non-medical

outpatient care Home care unemployment

inpatient care special equipment changes in job

diagnostic transportation early retirement

medical therapy assistant persons

Analysis of cost parameters

Quality of life

•Mobility

•Self-Care

•Usual Activities

•Pain/Discomfort

•Anxiety/Depression

90

80

70

60

50

40

30

20

10

100

0

Best imaginablehealth state

Worstimaginablehealth state

Your ownhealth state

today

EQ-5D

Data on resource utilization and quality of life

-3 months retrospectively

-3 months prospectively

Design

Study population

100 per country

Total of 1000 patients

stratified by different H&Y stages

Patients of EuroPa Registry of Parkinson´s

Disease

New patients

Economic data

- CRF A and CRF B

Clinical Data

- Minimal data set of the EuroPa registry

- CRF P

Quality of life

- EQ-5D

Data collection

Monitoring of

- data entered into the Minimal Data Set

Each center has to decide whether the monitor receives access to the data of the respective

country

(reading rights only)

Monitoring of Minimal Data Set

2. Handling of study documents

Study documents and CRFs

EuroPa Patient´s Registry

Patient Questionnaire Part A

Patient Questionnaire Part B

Investigator Questionnaire Part P

Baseline

Month 3

Please add the

patient´s address

Documents per patient provided to study center

Contains: Questionnaire A

Contains: Questionnaire B

Study center (Bonn)

Flow Chart: I) Patients registered in the EuroPa registry

One big envelope: including - envelope "day 1" (CRF A) - envelope "month 3" (CRF B)

Neurologische Klinik Bonn

B

a s e l

i

n

e

Neurologische Klinik Bonn

Your center

-send "CRF A" and "CRF B" to patient

- forward CRF "A" to study center Bonn

-forward "CRF B" to study center Bonn

Patient is asked to complete "CRF A"

Patient is asked to:-complete “ CRF B“

Patient

M

o

n

t h

3

Study Flow I

Additionally provided documents to center

C o u n t ry c o d e :

P a t ie n t c o d e :

( * t h is p r o je c t i s f u n d e d b y t h e E u ro p e a n c o m m i s s io n N o : Q L R T - 2 0 0 1 - 0 0 0 2 0 )

E u r o p e a n C o o p e r a t iv e N e t w o r k f o r

R e s e a r c h , D i a g n o s i s a n d T h e r a p y o f

P a r k in s o n ' s D is e a s e ( E u r o P a * )

I n v e s t ig a t o r

Q u e s t i o n n a i r e

P a r t P

•Box of CRF P

For patients not in the registry

•Center File

Including:

•Study protocol

• Study outline

•Patient Information

•Informed Consent Form

•Further documents

Study center (Bonn)

One big envelope: including - envelope "day 1" (CRF A) - envelope "month 3" (CRF B)

Neurologische Klinik Bonn

B

a s e l

i

n

e

Neurologische Klinik Bonn

Your center

Patient is asked to:-complete “ CRF B“

Patient

M

o

n

t h

3

Study Flow I

-“ CRF P“ is to be completed by the investigator

- “ CRF P“

-“ CRF A“ is to be completed by the patient

-“ CRF A“ / “ CRF P“ are to be sent to the study center Bonn

-“ CRF B“ is to be sent to the study center, Bonn

-“ CRF B“ is to be provided to the patient

Flow Chart: II) Patients not registered in the EuroPa registry

3. Monitoring process

Study Flow II

Data of the Patient´s Registry will be monitored at Study coordination center, Bonn

Process of Double Data Entry at

Study coordination center, Bonn

Data evaluation and analysis at

Study coordination center, Bonn

Reporting

Monitoring process

Centers are asked to provide

Monitoring access (reading-only rights)

Monitoring of center-specific data

Generating of Data query forms (DQF)

Sending Data query forms to study center

EuroPa Minimal Data Set Data Query Form (DQF)

Study center: Monitor: Investigator at study center: (Sub)- Investigator of data entry at study center: Date:

Patient Code No. of Question of MDS Parameter Problem Solution

Please correct/clarify the above noted problems to your earliest convenience! In case of any questions contact +49-228-5708 and ask for monitor named above.

Data Query Form

4. Study status and Timelines

  CRFs adapted to national system

by HE

Printing process

Documents at study center

Patient Recruitment

started

Monitoring Data entry

A x finalized        

CZ First draft          

D x finalized x 75 pts x x

E            

F x          

I            

NL x started        

P x finalized        

S            

UK            

Study status

Timelines (preparation of documents - data entry)

July-SeptemberOctober-

December

Translation of CRFs

Supplying physicians with

study material

Patient enrolment

Data entry

January-March

November

Centers:

for each completely received documented patient (CRFs)

compensation of Euro 50

Health Economists:

for translation of CRFs,

adaption to national health care system,

support of analysis

review of documents

Compensation

compensation of Euro 2000

Participants in the Economic study

Health Economists

A Prof. Dr. K. Pfeiffer CZ Dr. J. Skoupa E To be clarified F Prof. Dr. C. LePen G K. Berger I Dr. L. Mantovani NL Dr. T. Vergert P Dr. Céu Mateus S Dr. U. Persson UK To be clarified

Country