Please select the outcome measures that correspond to the clinical trial below.
Title: Comprehensive Information Imparted to Patients With Epilepsy and Comorbidity and Decreased Prevalence of Adverse Treatment Effects. The EDU-COM Study.
Brief Summary: Epilepsy requires long-term drug treatment and is frequently associated with other clinical conditions. Combinations of antiepileptic drugs and other compounds are fairly common and increase with age. Adverse drug reactions and drug interactions are expected and may affect compliance, particularly in patients not receiving adequate information. Primary objective of the study is to verify if a comprehensive and standardized educational plan is followed by a significant reduction of the number of adult patients with epilepsy and comorbidity presenting clinically relevant adverse treatment effects. Secondary objectives include effects on number of adverse treatment events, health-related quality of life (HRQOL), direct medical costs, and patient's compliance. The study is a randomized, controlled, open-label, pragmatic trial. Included are consecutive adult outpatients with 1+ concurrent clinical conditions on chronic treatment and at least one clinically relevant treatment-related adverse event and/or clinically relevant drug interaction. Eligible patients will be randomized to receive a comprehensive and standardized educational plan (experimental arm) or to usual care, ie management of adverse event/drug interaction as done in clinical practice (control arm). The experimental plan consists in discussing with patient and caregiver the cause and nature of adverse event/drug interaction, the tolerability profile of each drug, the clinical manifestations associated with current drug interaction(s), contraindications of potentially interfering over-the-counter drugs, indications and benefits of suggested treatment changes, and withdrawal of potentially interfering, contraindicated or ineffective drugs. All patients will be seen at one, three and six months after admission.

Expected results: The number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study is expected to be higher in patients assigned to comprehensive and standardized educational plan compared to usual care (primary outcome). Patients on the experimental plan are also expected to be more commonly free from relevant adverse events and/or drug interactions at each intermediate visit, to present a lower number of adverse treatment events, to imply lower costs for medical contacts, hospital admissions, and drugs, to present better HRQOL scores, and to present less weekly treatment omissions.


Options:
A: Severity of depressive symptoms (7 Days)
B: Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9) (Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline))
C: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
D: The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study. (6 months)

Answer: D