Peterson 1984.
Methods |
Study design: RCT Method of randomisation: coin‐toss randomisation. Setting: outpatient clinic at a hospital in Australia. Date it was conducted: not reported. Follow‐up: 4 weeks and 6 months. Source of funding: Astra Pharmaceuticals (pty) ltd supplied Dosetts Conflict of interest: not reported. |
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Participants |
Inclusion/exclusion criteria: people who were consecutive attenders at outpatient clinics during the study period, who were responsible for their own medication and who possessed a hospital pharmacy prescription book. Sample size: 53 participants were recruited. At follow‐up, 2 participants from the control group and 1 from the intervention group had not returned to the clinic and were excluded from the analysis. Gender: 15 (58%) men were included in the intervention group and 15 (56%) in the control group. Age: median age was 35 years (range 19 to 74) in the IG and 28 years (range 18 to 64) in the CG. Gender: female 44% in the IG and 42% in CG. |
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Interventions |
Type of intervention: mixed Intervention group participants were counselled 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 participants' everyday habits; participants were given a copy of an educational leaflet; each participant was provided with a 'Dosett' medication container (pill organiser) and was counselled on its use; participants were instructed to use a medication/seizure diary; and participants were reminded by mail of upcoming appointments and of missed prescription refills. |
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Outcomes |
Primary outcome(s) measured: adherence It was assessed by (1) changes in plasma anticonvulsant levels (provided that the participant's medication regimen had not been altered in the preceding 2 weeks), (2) a check of the participant's prescription record book to determine prescription refill frequency (if refill frequency was 1 or more weeks later than expected at least once during the previous 6 months, the participant was considered non‐adherent) and (3) participant appointment‐keeping frequency (those who had attended all scheduled appointments in the previous 6 months were considered compliant). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Coin toss was reported |
Allocation concealment (selection bias) | Unclear risk | No information on concealment was reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The physicians were blinded to the allocated interventions |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The information on blinding of other parties (e.g. outcome assessors) was not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting of attrition/exclusions to permit judgement |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | Insufficient rationale or evidence that an identified problem will introduce bias |