Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective Study on Long-term Outcome and Potential Usefulness fo an Intervention Aimed at Reducing Adverse Effects in Patients With Refractory Epilepsy
Brief Summary: Over 1 million people in the European Union (EU) suffer from chronic refractory epilepsy. Their quality of life (QoL) is severely affected by seizures and by the adverse effect of antiepileptic drug (AED) treatment. Several new AEDs have been introduced in recent years, but their impact on the long-term outcome in these patients has been inadequately explored. Preliminary data from the U.S. suggests that using a standardize toll to quantitate adverse AED effects can improve outcome, but the general applicability of these findings is unclear.

Objectives: 1) To assess prospectively AED utilization patterns in patients with refractory epilepsy ; 2) to assess how such treatments and other variables correlated with seizure control, adverse effects, and QoL in these patients; 3) to establish the impact of a standardized evaluation of adverse effects on clinical outcome.

Methods: The project included a core observational study and a randomized intervention in a subcohort.

In the core (observational) study, 1,000 consecutive refractory epilepsy patients were enrolled and followed-up prospectively at 10 centres in Italy. The following parameters were recorded at 0 (entry), 6, 12 and 18 months: (i) drug therapy; (ii) seizure frequency; (iii) adverse events based on medical examination and non-structured interview; (iii) treatment costs and, (iv) for patients above age 16, standardized questionnaires for adverse effects (AEP), depressive symptoms (Becks Depression Scale, BDS), QoL (QOLIE-31) and clinical global impression (CGI). The primary outcome (changes in QOLIE-31 scores) will be related to the other variables measured.

In the randomized intervention, the subcohort meeting specific eligibility criteria (age \>16 years, no progressive disorder, AEP score\>=45 ) was randomized to two groups. In the intervention group, AEP score results were made available to the physician at each visit, while in the other group AEP scores were only made available at the end of follow-up. Primary outcome were changes in AEP score.


Options:
A: Arm Label: A; Type: EXPERIMENTAL; Interventions: Behavioral: Questioners | Arm Label: B; Type: EXPERIMENTAL; Interventions: Behavioral: STAR website | Intervention Type: BEHAVIORAL; Name: Questioners; Assigned to Arm(s): A | Intervention Type: BEHAVIORAL; Name: STAR website; Assigned to Arm(s): B
B: Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: AEP score available to the treating physician | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: AEP score available to the treating physician; Assigned to Arm(s): Intervention group
C: Arm Label: Personal counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Personal Counseling | Arm Label: Computer generated feedback letters; Type: EXPERIMENTAL; Interventions: Behavioral: Computer-generated feedback letters | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Personal Counseling; Assigned to Arm(s): Personal counseling | Intervention Type: BEHAVIORAL; Name: Computer-generated feedback letters; Assigned to Arm(s): Computer generated feedback letters
D: Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Behavioral: HITCM+CP | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HITCM only | Intervention Type: BEHAVIORAL; Name: HITCM+CP; Assigned to Arm(s): Arm 1 | Intervention Type: BEHAVIORAL; Name: HITCM only; Assigned to Arm(s): Arm 2

Answer: B