| Methods |
Coin toss randomization |
| Participants |
Adult and teenage epileptic patients, who were consecutive attenders at outpatient clinics during a 4‐month period, who were responsible for their own medication, and who possessed a hospital pharmacy prescription book, were included in the study |
| Interventions |
Patients in the intervention group received several adherence‐improving strategies: patients were counseled on the goals of anticonvulsant therapy and the importance of good adherence in achieving these goals, a schedule of medication taking was devised that corresponded with the patient's everyday habits, patients were given a copy of an educational leaflet, each patient was provided with a 'Dosett' medication container and counseled on its utility, patients were instructed to use a medication/seizure diary, and patients were reminded by mail of upcoming appointments and of missed prescription refills. The control group received none of these interventions. The mean daily dosages of the most commonly prescribed anticonvulsant drugs (phenytoin, carbamazepine, and sodium valproate) were not significantly different between the 2 groups |
| Outcomes |
Each patient had plasma anticonvulsant levels measured (provided that the patient's medication regimen had not been altered in the preceding 2 weeks), the patient's prescription record book was checked to assess prescription refill frequency (if the refill frequency was 1 or more weeks later than expected at least once during the previous 6 months, the patient was considered non‐adherent), and patient appointment‐keeping frequency (patients who had attended all their scheduled appointments in the previous 6 months were considered compliant) were assessed. The median number of self recorded seizures experienced by each patient was compared between the control and intervention groups |
| Notes |
Physicians were blinded to the intervention group of their patients |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Coin toss was used. "The patients were randomly allocated (by toss of a coin) to either a control or an intervention group" (pg 412) |
| Allocation concealment (selection bias) |
Unclear risk |
No information was provided about how allocation was handled |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias |
Unclear risk |
Insufficient information provided to assess this |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) PLASMA ANTICONVULSANT LEVELS ‐ The author notes that the clinical chemistry staff were blinded, and in fact unaware of the study's details |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) MEDIAN NUMBER OF SEIZURES ‐ The author notes that all hospital personnel were blinded |
| Blinding of participants (performance bias)
Adherence measure |
Low risk |
(PRIMARY) PLASMA ANTICONVULSANT LEVELS ‐ No mention of blinding of patients; likely not done but measurement of drug levels in blood may be part of routine care |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) MEDIAN NUMBER OF SEIZURES ‐ Any blinding could have been broken due to the nature of the intervention |
| Blinding of personnel (performance bias)
Adherence measure |
Low risk |
(PRIMARY) PLASMA ANTICONVULSANT LEVELS ‐ The author notes that all hospital personnel were blinded |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) MEDIAN NUMBER OF SEIZURES ‐ The author notes that all hospital personnel were blinded |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) PLASMA ANTICONVULSANT LEVELS ‐ No mention of reasons for missing data though missing data are nearly balanced across groups |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) MEDIAN NUMBER OF SEIZURES ‐ No mention of reasons for missing data though missing data are nearly balanced across groups |
