Implementation strategies for a Scottish national epilepsy guideline in primary care: results of the Tayside Implementation of Guidelines in Epilepsy Randomized (TIGER) trial.

PURPOSE: To determine the effectiveness of two dissemination and implementation strategies to implement a national guideline for epilepsy management in primary care settings. METHODS: Three-arm cluster-randomized controlled trial. The participants were general practitioners from 68 practices in Tayside, Scotland, and 1,133 of their patients with self-reported epilepsy treated with antiepileptic medications (AEDs). Practices were randomized blind to a control, intermediate, or intensive intervention. CONTROL: Postal dissemination of a nationally developed clinical guideline. Intermediate intervention: Postal dissemination of the guideline supported by interactive, accredited workshops, and dedicated, structured protocol documents. Intensive intervention: Intermediate intervention plus a nurse specialist who supported and educated practices in the establishment of epilepsy review clinics. The primary outcome was the SF-36 health-related quality-of-life instrument. Secondary measures were a battery of prevalidated epilepsy-specific quality-of-life instruments. These were administered at baseline and after the intervention phase. Process of care was assessed by case-note review on number of review meetings and counseling sessions for epilepsy before and after the interventions. RESULTS: None of the intervention groups showed any change in the primary or secondary outcome measures or process-of-care measures. CONCLUSIONS: None of the intervention strategies led to improvements in patient quality of life or quality of epilepsy care. Further research is needed to discover why the interventions failed, to identify barriers to adoption of guidelines, and to develop strategies that might improve implementation and uptake in the future.

A randomised placebo controlled exploratory study of vitamin B-12, lofepramine, and L-phenylalanine (the "Cari Loder regime") in the treatment of multiple sclerosis.

OBJECTIVE: To determine whether combination therapy with lofepramine, L-phenylalanine, and intramuscular vitamin B-12 (the "Cari Loder regime") reduces disability in patients with multiple sclerosis. METHODS: A placebo controlled, double blind, randomised study carried out in five United Kingdom centres on outpatients with clinically definite multiple sclerosis, measurable disability on Guy's neurological disability scale (GNDS), no relapse in the preceding six months, and not on antidepressant drugs. Over 24 weeks all patients received vitamin B-12, 1 mg intramuscularly weekly, and either lofepramine 70 mg and L-phenylalanine 500 mg twice daily, or matching placebo tablets. Outcome was assessed using the GNDS, the Kurtzke expanded disability status scale; the Beck depression inventory, the Chalder fatigue scale, and the Gulick MS specific symptom scale. RESULTS: 138 patients were entered, and two were lost from each group. There was no statistically significant difference between the groups at entry or at follow up. Analysis of covariance suggested that treated patients had better outcomes on four of the five scales used. Both groups showed a reduction of 2 GNDS points within the first two weeks, and when data from all time points were considered, the treated group had a significant improvement of 0.6 GNDS points from two weeks onwards. CONCLUSIONS: Patients with multiple sclerosis improved by 2 GNDS points after starting vitamin B-12 injections. The addition of lofepramine and L-phenylalanine added a further 0.6 points benefit. More research is needed to confirm and explore the significance of this clinically small difference.

The costs of trauma caused by seizures: can they be reduced?

This study surveyed admissions of patients with trauma caused by seizures from a population of over 400 000 to a Regional Neurosurgery, Plastic Surgery, Orthopaedic Surgical Services and a short-stay ward. Information on duration of epilepsy, seizure type, antiepileptic drugs (AEDs) and the co-existence of other neurological or psychiatric factors was reviewed and the hospital costs calculated. Twelve patients (eight males, four females, aged 28 to 78 years) had 13 admissions with 14 injuries caused by seizures during the period August 1995 to November 1998 (1% of the total admissions with the diagnosis of epilepsy). Seven had head-injuries, four had limb fractures or dislocations, two had burns and one had severe lacerations. The average duration of stays were between 1 day (short-stay ward) and 9-24 days for the three major services. The direct healthcare costs of this small group were high ( L 49 421) or L 3802 per traumatic incident. Clinical review suggested that the trauma could have been prevented by alternative care in seven patients at the most optimistic. Epilepsy is uncommon as a cause of severe trauma, the seizures may be difficult to prevent and the direct healthcare costs are high.