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

Analysis of cost parameters

Quality of life Mobility Self-Care Usual Activities Pain/Discomfort Anxiety/Depression Best imaginable health state Worst imaginable health state Your own health 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) 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 Month3Month3 Study Flow I

Additionally provided documents to center 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 Month3Month3 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

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

Data Query Form

4. Study status and Timelines

CRFs adapted to national system by HE Printing process Documents at study center Patient Recruitment started MonitoringData entry Axfinalized CZFirst draft Dxfinalizedx75 ptsxx E Fx I NLxstarted Pxfinalized 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 Country