Comprehensive educational plan for patients with epilepsy and comorbidity (EDU-COM): a pragmatic randomised trial
Abstract
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 ClinicalTrials.gov, identifier NCT01804322, (http://www.clinicaltrials.gov).
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One study only included adults with epilepsy and other chronic comorbidities because the intervention targeted adverse effects stemming from drug interactions.
“One study only included adults with epilepsy and other chronic comorbidities, 44 because the intervention targeted adverse effects stemming from drug interactions.”
From Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life (2018) · cites this paper as [44]
Six interventions (25%) were delivered through individual sessions.
“6 interventions (25%) were delivered through individual sessions, 9,15,26,27,43,44,48”
From Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life (2018) · cites this paper as [44]
The remaining 7 studies (29%) employed a usual care (UC)/treatment as usual (TAU) control group.
“The remaining 7 studies (29%) employed a usual care (UC)/treatment as usual (TAU) control group. 26,27,31,41,44,48 -50”
From Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life (2018) · cites this paper as [44]
One pragmatic design (4%) left the delivery of the educational intervention to the treating physician.
“One pragmatic design (4%) left the delivery of the educational intervention to the treating physician. 44”
From Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life (2018) · cites this paper as [44]
Eight studies (33%) were rated as low risk for attrition bias as there was only a small number of missing data, which were balanced across the groups with justifiable reasons.
“Eight studies (33%) 27,29,36,38,39,44,48,49 were rated as low risk as there was only a small number of missing data, which were balanced across the groups with justifiable reasons.”
From Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life (2018) · cites this paper as [44]
A rating of low ROB was confirmed based on document review of registered protocols provided by the authors for 9 studies (37%).
“A rating of low ROB was confirmed based on document review of registered protocols provided by the authors for 9 studies (37%). 32,36,40,42,44 -46,49,50”
From Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life (2018) · cites this paper as [44]
In the QOLIE-31 study Beretta 44, the intervention group had a mean postintervention score of 63.00 (SD 15.48) versus control 65.04 (SD 14.38), P=.0070.
“Beretta 44 | 63.00 | 15.48 | 65.04 | 14.38 | .0070”
From Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life (2018) · cites this paper as [44]
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- Authors
- Beretta, S., Beghi, E., Messina, P., Gerardi, F., Pescini, F., La Licata, A., Specchio, L., Ferrara, M., Canevini, M. P., Turner, K., La Briola, F., Franceschetti, S., Binelli, S., Giglioli, I., Galimberti, C. A., Fattore, C., Zaccara, G., Tramacere, L., Sasanelli, F., Pirovano, M., & Ferrarese, C.
- Affiliations
- University of Milano-Bicocca (IT)
- Mario Negri Institute for Pharmacological Research (IT)
- Azienda Ospedaliero-Universitaria Careggi (IT)
- University of Foggia (IT)
- University of Milan (IT)
- Fondazione IRCCS Istituto Neurologico Carlo Besta (IT)
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino (IT)
- Santa Maria Nuova Hospital (IT)
- Corresponding author
- Beretta, S.
- ORCID
- Venue
- Journal of Neurology, Neurosurgery & Psychiatry
- Publisher
- BMJ
- Published
- 2014-01-08
- Volume
- 85
- Issue
- 8
- Pages
- 889-894
- ISSN
- 0022-3050 (ISSN-L)
- OpenAlex
- W2136282551
- Cited by
- 19
- References
- 32
- Citations by year
- 2025: 2 · 2024: 1 · 2021: 2 · 2020: 1 · 2019: 2 · 2018: 4 · 2017: 6 · 2016: 1
- FWCI
- 1.78
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Neurology Neurosurgery & Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Epilepsy research and treatment
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacy and Medical Practices
- Keywords
- epilepsy, comorbidities, patient education, drug interactions, adverse drug reactions, drug-related problems, multidrug therapy, health-related quality of life, health care costs
- MeSH terms
- Adolescent, Adult, Aged, Anticonvulsants, Data Interpretation, Statistical, Drug Interactions, Epilepsy, Female, Humans, Male, Middle Aged, Patient Education as Topic, Quality of Life, Socioeconomic Factors, Bias, Single-Blind Method, Treatment Outcome, Outcome Assessment, Health Care, Cost of Illness, Sample Size, Patient-Centered Care, Endpoint Determination, Young Adult
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