1. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 1 THE COMOESTAS PROJECT Round Table

2. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 WHAT IS THE COMOESTAS PROJECT? 2 Dr. MARTA ALLENA Headache Science Centre, IRCCS “National Neurological Institute C. Mondino” Foundation and University of Pavia, Italy

3. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 COMOESTAS is an e-health project funded by the European Commission, conceived with the aim of offering an innovative approach to a chronic disease.

4. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 The call…

5. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Expected impact: 1.World-leading levels of patient safety with fewer medical errors and optimised medical interventions resulting in savings of lives and resources. 2.Early alerts and improved management of large scale health-related crises through effective and automated risk prediction, assessment and management. 3.Accelerated and wider adoption of future electronic health record systems. Latin America 4.International cooperation between EU constituency and the Latin America counterpart. Uptake of EU standards in the electronic Health Records area in Latin America.

6. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 6 COMOESTAS PROJECT 2008-2010 VII FRAMEWORK PROGRAMME Grant agreement no. 215366

7. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 COMOESTAS is an e-health project funded by the European Commission, started in January 2008 and conceived with the aim of offering an innovative approach to MOH (Medication Overuse Headache). Medication-overuse headache (MOH) is a model for testing and improving the “continuous” management of chronic neurological diseases

8. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Daily or almost-daily headache resulting from the chronicization of migraine or tension-type headache, due to the progressive increase in the use of symptomatic drugs. MOH affects 1.4 to 3% of the general population and markedly deteriorates the quality of life of patients (highly disabling disorder). Treatment: withdrawal of the overused medication(s) followed by prophylactic treatment. Outcome: Most patients improve, but, after a few months, a relevant proportion (up to 45%) relapses MEDICATION OVERUSE HEADACHE

9. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Is it possible an ICT-assisted approach for MOH? In order to avoid the risk of relapse, a close and continuous observation of MOH patients is advisable. This can be achieved through an ICT-assisted procedure, providing the neurologist with a powerful and flexible tool for monitoring, interacting, alerting and decision supporting. Such a tool will stimulate the active participation of the patient in the treatment process. MEDICATION OVERUSE HEADACHE

10. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Fondazione Istituto Neurologico Casimiro Mondino, Pavia, ITALY (coordinator) Consorzio di Bioingegneria ed Informatica Medica, Pavia, ITALY Danish Headache Center, Department of Neurology, Glostrup Hospital, University of Copenhagen, DENMARK Universitaet Duisburg-Essen, GERMANY Fundación de la Comunidad Valenciana, Hospital Clínico Universitario De Valencia, SPAIN Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia (FLENI), Buenos Aires, ARGENTINA Fundación Isalud, ARGENTINA Fundación Isalud, Buenos Aires, ARGENTINA Pontificia Universidad Catòlica de Chile, Santiago, CHILE CF consulting Finanziamenti Unione Europea s.r.l., Milan, ITALY

11. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Improving the quality and efficiency of healthcare systems by means of continuous monitoring of patients needs/problems, communication between patients and physicians and personalization of care; Increasing patient safety by optimising medical interventions, preventing errors and reducing drug-induced side effects; Reducing the burden of disease via the control of attacks and consumed symptomatic drugs and improving the patients quality of life; Reducing direct and indirect costs provoked by the condition; Favouring the uptake of EU standards in healthcare informatics, clinical protocols, patient treatment and management in Latin American Countries. COMOESTAS PROJECT: OBJECTIVES

12. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 The ICT core of COMOESTAS is Interactive Electronic Patient Record the Interactive Electronic Patient Record (IEPR), which includes the following features: Minimum Data Set: Minimum Data Set: helps defining the diagnosis, the process of detoxification and the subsequent therapy; MOH Electronic Diary: MOH Electronic Diary: allows monitoring of patients and is supported by an Alerting and Decision Support System: if Alerting and Decision Support System: if parameters exceed certain values, automatic alerts warn physicians or patient or both Second opinion system Second opinion system

13. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010

14. THECOMOESTAS PROTOCOL THE COMOESTAS PROTOCOL 14

15. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 THE THREE MAINSTAYS IN MOH MANAGEMENT 1)TO WITHDRAW THE OVERUSED DRUG; 2)TO ALLEVIATE THE WITHDRAWAL SYMPTOMS BY MEANS OF A BRIDGING PROGRAMME, INCLUDING PHARMACOLOGICAL AND NON-PHARMACOLOGICAL SUPPORT, DESIGNED TO HELP THE PATIENTS TO TOLERATE THE WITHDRAWAL PROCESS; 3)TO PREVENT RELAPSES.

16. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Classic approach Classic approach IEPR-assisted approach IEPR-assisted approach THE CONCEPT vs  Classic approach  IEPR-assisted approach > Patient - diagnosed - detoxified - put on prophylactic medication Patient - diagnosed - detoxified - put on prophylactic medication - followed-up with ICT Demonstrate that we can improve the outcome of MOH by means of ICT

17. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 STUDY PLAN - I MULTICENTRE PARALLEL GROUP STUDY CONDUCTED IN 6 CENTRES FOR CLINICAL EVALUATION: Danish Headache Center, Copenhagen, DENMARK Universitaet Duisburg-Essen, GERMANY Hospital Clínico Universitario De Valencia, SPAIN FLENI, Buenos Aires, ARGENTINA Pontificia Universidad Catòlica de Chile, Santiago, CHILE Fondazione Istituto Neurologico Casimiro Mondino, Pavia, ITALY

18. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 STUDY PLAN - II TWO PARALLEL ARMS: CLASSIC APPROACH TO MOH; IEPR-BASED APPROACH TO MOH. EACH ARM WILL LAST 12 MONTHS

19. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 STUDY PLAN - III EACH CENTRE AIMED AT ENROLLING 50 MOH PATIENTS PER ARM, WHO HAVE BEEN EVALUATED OVER A PERIOD OF 6 MONTHS ACCORDING TO THE BELOW-REPORTED SCHEDULE

20. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Detox Flow-chart - Classic approach

21. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 FLOW-CHART IEPR-BASED APPROACH Pre-enrolment, Minimum Data Set is applied and if patient is MOH suspect he/she is asked to fill in a paper diary. Visit 0

22. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Visit 1 Patient is re-evaluated and the diary checked. If inclusion criteria are satisfied, patient is definitely enrolled.

23. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Detox The patient undergoes detoxification according to the same protocol adopted for the classic approach

24. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 24 DETOXIFICATION PROTOCOL

25. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Detox The patient is prescribed prophylactic medication, is trained to use the electronic diary and associated alert system, and is scheduled for Visit 2. After the end of detoxification, parameters exceed certain values, automatic alerts warn physicians that are able to communicate with the patient and/or change therapy

26. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Visit 2 The patient is re-evaluated along with the electronic diary. The patient is asked to keep up using the electronic diary and associated alert system, and is scheduled for visit 3.

27. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Contact The patient is contacted by phone

28. COMOESTAS – Grant agreement no. 215366 Final Conference, Buenos Aires, November 26 th, 2010 Visit 3 The patient is re-evaluated along with the electronic data. The study ends