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Research paper
Comprehensive educational plan for patients with epilepsy and comorbidity (EDU-COM): a pragmatic randomised trial
  1. Simone Beretta1,
  2. Ettore Beghi2,
  3. Paolo Messina2,
  4. Francesca Gerardi2,
  5. Francesca Pescini3,
  6. Andrea La Licata3,
  7. Luigi Specchio4,
  8. Mariangela Ferrara4,
  9. Maria Paola Canevini5,
  10. Katherine Turner5,
  11. Francesca La Briola5,
  12. Silvana Franceschetti6,
  13. Simona Binelli6,
  14. Isabella Giglioli6,
  15. Carlo Andrea Galimberti7,
  16. Cinzia Fattore8,
  17. Gaetano Zaccara9,
  18. Luciana Tramacere9,
  19. Francesco Sasanelli10,
  20. Marta Pirovano10,
  21. Carlo Ferrarese1
  1. 1Department of Neurology, San Gerardo Hospital, University of Milano Bicocca, Monza, Italy
  2. 2IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy
  3. 3Department of Neuroscience, Careggi Hospital, Firenze, Italy
  4. 4Department of Medical and Experimental Sciences, Ospedali Riuniti, University of Foggia, Foggia, Italy
  5. 5Health Sciences Department, Epilepsy Center, San Paolo Hospital, University of Milano, Milano, Italy
  6. 6Neurophysiology Unit, Fondazione Carlo Besta Neurological Institute, Milano, Italy
  7. 7Neurophysiology Unit, Fondazione Istituto C. Mondino, Pavia, Italy
  8. 8Clinical Trial Center & Antiepileptic Drugs, Fondazione Istituto “C. Mondino”, Pavia, Italy
  9. 9Department of Neurology, S. Maria Nuova Hospital, Firenze, Italy
  10. 10Department of Neurology, Ospedale di Circolo, Melegnano, Italy
  1. Correspondence to Dr Simone Beretta, Department of Neurology, San Gerardo Hospital, Via Pergolesi 33, Monza 20900, Italy; simone.beretta{at}


Background The impact of educational strategies in the management of adverse treatment effects and drug interactions in adult patients with epilepsy with comorbidities remains undetermined.

Objective The EDU-COM study is a randomised, pragmatic trial investigating the effect of a patient-tailored educational plan in patients with epilepsy with comorbidity.

Methods 174 adult patients with epilepsy with chronic comorbidities, multiple-drug therapy and reporting at least one adverse treatment effect and/or drug interaction at study entry were randomly assigned to the educational plan or usual care. The primary endpoint was the number of patients becoming free from adverse treatment events and/or drug interactions after a 6-month follow-up. The number of adverse treatment events and drug interactions, health-related quality of life (HRQOL) summary score changes and the monetary costs of medical contacts and drugs were assessed as secondary outcomes.

Results The primary endpoint was met by 44.0% of patients receiving the educational plan versus 28.9% of those on usual care (p=0.0399). The control group reported a significantly higher risk not to meet successfully the primary endpoint at the end of the study: OR (95% CI) of 2.29 (1.03 to 5.09). A separate analysis on drug adverse effects and drug interactions showed that the latter were more sensitive to the effect of educational treatment. Quality of life and costs were not significantly different in the two groups.

Conclusions A patient-tailored educational strategy is effective in reducing drug-related problems (particularly drug interactions) in epilepsy patients with chronic comorbidities, without adding significant monetary costs. Registered at, identifier NCT01804322, (


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