Jacobi‐Polishook 2009.
Study characteristics | ||
Methods | Single‐day, randomised, controlled, parallel, double‐blind trial with 2 arms investigating postural stability in 24 children with ADHD:
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Participants | Number of participants screened: 80 Number of participants included: 24 (22 boys, 2 girls) Number of participants followed up: 24 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: MPH mean 10.06 years (range 7‐16), placebo mean 10.88 years (range 7‐16) MPH‐naive: 0% Ethnicity: not stated Country: Israel Setting: outpatient clinic Comorbidity: not stated Comedication: no IQ: > 70 Other sociodemographics: none No significant difference in baseline demographics were noted between the 2 groups Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 5 mg of SA‐MPH or 5 mg placebo Number randomised to each group: MPH 12, placebo 12 Mean medication dosage: not stated Administration schedule: 5 mg x 1 (single dose) Duration of intervention: 1 day Washout before trial intervention: 24 h Titration period: none Treatment compliance: 100% |
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Outcomes |
Serious AEs
Non‐serious AEs
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Notes | Sample calculation: yes Ethics approval: no information Key conclusions of trial authors
Inclusion of MPH responders only/exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes; see 'Inclusion criteria' Any withdrawals due to AEs: no Funding source: not declared Any withdrawals due to AEs: no |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation using a table of random numbers |
Allocation concealment (selection bias) | Low risk | Placebo pill was identical in appearance to the MPH pill |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and tester administering the examination were blinded to group assignments |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants and tester administering the examination were blinded to group assignments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts in either group Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Low risk | Outcomes reported according to protocol |