Wilkison 1995.
Study characteristics | ||
Methods | Double‐blind, placebo‐controlled, cross‐over trial with 2 interventions:
Phases: 2 |
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Participants | Number of participants screened: not stated Number of participants included: 16 Number of participants followed up: 16 implied (16 boys, 0 girls) Number of withdrawals: not stated Diagnosis of ADHD: DSM‐III‐R (subtype not stated) Age: mean 10.2 years (range 8‐13) IQ: mean 112.6 MPH‐naive: 0% Ethnicity: not stated Country: USA Setting: outpatient clinic Comorbidity: no Comedication: not stated 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 MPH (normal dose) and placebo Mean MPH dosage: 0.030 mg/kg (range 0.08 to 1.10 mg/kg/d) Administration schedule: not stated Duration of each medication condition: 36 h Washout before trial initiation: not stated Titration period: not stated Treatment compliance: not stated |
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Outcomes |
General behaviour
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Notes | Sample calculation: not described Ethics approval: not described Key conclusion of trial authors
Comment from review authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes, only participants who responded positively to MPH included Any withdrawals due to AEs: unclear Funding source: a University of Utah Biomedical Sciences Research Grant and a grant from the University Research Committee Email correspondence with trial authors: May 2014. We obtained supplemental information from trial authors (Magnusson 2014c [pers comm]) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | From correspondence: "generated by pharmacist" (Magnusson 2014c [pers comm]) |
Allocation concealment (selection bias) | Low risk | From correspondence: "recruiter had no involvement in and was blinded to allocation sequence" (Magnusson 2014c [pers comm]) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | From correspondence: "pharmacist instructed parents (via instructions on pill bottle) regarding which pills should be administered and at what time" (Magnusson 2014c [pers comm]) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | See above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | From correspondence: "approximately 2% of skin conductance and heart rate data were affected by participant movement and were replaced with interpolated values Physiological data were lost for 2 participants with ADHD and for 2 participants without ADHD. For 3 of the remaining 28 participants, 1 of the 4 repeated measurements of interbeat intervals was replaced with the mean of the participant's diagnostic group because his ECG recordings were inadequate" (Magnusson 2014c [pers comm]) Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Low risk | No indication of reporting bias |