Shope 1980.
Study characteristics | ||
Methods |
Study design: RCT Method of randomisation: not reported Setting: 1 paediatric seizure clinic in the USA Date it was conducted: March 1977‐ April 1978 Follow‐up: 11 weeks following the intervention Source of funding: Epilepsy Foundation of America, Epilepsy Center of Michigan Conflict of interest: not reported |
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Participants |
Inclusion/exclusion criteria: children were eligible if they were prescribed a continuing dosage of phenobarbital and/or phenytoin; < 16 years of age; the only child of the family; accompanied by the person who took primary care of the child Sample size: 211 children were recruited. 70 children were judged non‐compliant because serum levels were below predicted levels for individual age and dosage. 3 children were dropped from the study because their physician discontinued their medication. Parents of the 67 children remaining in the study were allocated to IG (28 parents) and CG (37 parents). Of the 28 parents invited to the discussion meeting, only 14 attended the discussion. Age: mean age was 9 years and ranged from 1‐15 years. Mean age of children in the CG was significantly higher than children assigned to the IG. Gender: half of children were girls and 67% were black. Other characteristics: half of the parents had < 11th grade education and income < USD 8330. |
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Interventions |
Type of intervention: educational 2 mothers' discussion group meetings, each lasting 1.5 h. The aim of these meetings was to provide mothers with information to enable them to know what to do for their children and why, increasing their sense of responsibility and obtaining their commitment. Follow‐up and interview and laboratory results were obtained at regularly‐scheduled visits, a mean of 11 weeks following the discussion session. |
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Outcomes |
Primary outcome(s) measured: adherence It was assessed by measurement of serum drug levels and expressed as a score ranging from 1‐4. 1 indicated zero level of medication in the serum, 2 indicated > 30% less than predicted, 3 indicated within predicted mean and 4 indicated 30% more than predicted mean. Secondary outcome(s) measured: knowledge of seizure disorder, locus of control and dependency |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation was not reported |
Allocation concealment (selection bias) | Unclear risk | No information on concealment was reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on blinding was reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding was 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 to permit judgement |