Brown 2009.
Study characteristics | ||
Methods |
Study design: RCT Methods of randomisation: a computerised, random‐number generator Follow‐up: 4 weeks Setting: 5 outpatient clinics at 1 hospital in the UK Date it was conducted: participants were recruited between January and June 2007 Source of funding: Janssen Cilag, Epilepsy Action, and the University of Sheffield Conflict of interest: not reported |
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Participants |
Inclusion/exclusion criteria: people > 16 years of age. Patients were excluded if they were already using an adherence‐enhancing method that could be compromised if they took part in the study, if they were receiving a diagnosis of epilepsy for the first time or if they had learning difficulty. Sample size: 81 participants were recruited; 12 participants did not complete follow‐up measures, as they did not return their MEMS medication monitor bottles. Gender: 27 (40%) were men. Age: mean age was 41 years (SD 15.4) in the IG and 44 years (SD 16.4) in the CG. |
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Interventions |
Type of intervention: behavioural All participants completed a 14‐page packet of self‐report measures. The IG group participants were given an additional worksheet on which they specified the environmental cues for tablet taking, using the format of an "if/then" plan. This means participants would write when and where they intended to take their medication every day, and what they would be doing at the moment of taking it. |
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Outcomes |
Primary outcome measured: adherence It was measured via MEMS, an electronic monitoring cap that recorded the number and timing of bottle openings. From this information, the percentage of prescribed doses taken and the percentage of doses taken on time were calculated. Overall adherence scores were generated by standardising and then averaging the 3 percentage measures. Secondary outcome(s) measured: the number of missed doses during the preceding month, the Brief Illness Perception Questionnaire and the Liverpool Seizure Severity Scale were administered at baseline and at follow‐up. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised random‐number generator 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 doctors and clinic and pharmacy staff were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Information on blinding of other parties (e.g. outcome assessor) was not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Missing outcome data were reported and likely to be related to true outcome |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes |
Other bias | Unclear risk | Insufficient rationale or evidence to permit judgement |