cost-of-care and quality of life of patients with parkinson´s disease in europe
TRANSCRIPT
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