Lufi 1997.
Study characteristics | ||
Methods | Cross‐over trial with 2 interventions:
Phases: participants randomly assigned to 3 weeks of MPH, 3 weeks of placebo. No washout. Assessment at baseline and by the end of each phase |
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Participants | Number of participants screened: not stated Number of participants included: 20 (18 boys, 2 girls) Number of participants followed up: 20 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: mean 9.23 years (± 1.62, range 7.17‐12.42) IQ: > 70 MPH‐naive: 100% Ethnicity: not stated Country: Israel Setting: outpatient clinic Comorbidity: none Comedication: no Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 2 possible drug condition orders of 10 mg MPH and placebo Mean MPH dosage: 10 mg/d Administration schedule: mornings Duration of each medication condition: 3 weeks Washout before trial initiation: all participants were treatment‐naive Medication‐free period between interventions: none Titration period: none Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
General behaviour
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Notes | Sample calculation: not stated Ethics approval: not stated Comment from trial authors
Key conclusions of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: no Funding source: not declared Email correspondence with trial authors: September 2013. We obtained supplemental information/data from trial authors |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Everyone involved in the assessment phase ...was blind to the type of medication..." All medications (both placebo and MPH) were given in identical capsules to prevent recognition of the true medication |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "...the parents, the teacher, the child and the psychologist who tested the child did not know what kind of medication the child was taking..." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |