Tervo 2002.

Study characteristics
Methods	Triple‐blind, 3‐way, cross‐over trial with 2 interventions: LD‐MPH and HD‐MPH placebo Phases HD‐MPH: 0.3 mg/kg twice/d LD‐MPH: 0.05 mg/kg twice/d
Participants	Number of participants screened: not stated Number of participants included: 63 (49 boys, 14 girls) Number of participants followed up: 49 Number of withdrawals: 14 Diagnosis of ADHD: DSM‐IV (combined (70%), hyperactive‐impulsive (16%), inattentive (5%), other (9%)) Age: mean 9 years 10 months (SD 2 years 10 months; range not stated) IQ: not stated MPH‐naive: not stated Ethnicity: not stated Country: USA Setting: outpatient clinic Comorbidity: motor dysfunction (35%) Comedication: not stated Other sociodemographics: none Inclusion criteria Not stated Exclusion criteria Not stated
Interventions	Participants were randomly assigned to 1 of 2 possible dose levels of IR‐MPH and placebo Mean MPH dosage: not stated Administration schedule: twice daily; time points not stated Duration of each medication condition: 6 days Washout before trial initiation: 1 day Titration period: none Treatment compliance: not stated
Outcomes	ADHD symptoms CPRS: parent‐rated at baseline and at end of period CTRS: teacher‐rated at baseline and at end of period General behaviour CBCL: parent‐rated at baseline and at end of period Home Situations Questionnaire: parent‐rated at baseline and at end of period Teacher report form (similar to CBCL): teacher‐rated at baseline and at end of period School Situations Questionnaire: teacher‐rated at baseline and at end of period Non‐serious AEs Side Effects Rating Scale: parent, at baseline and at end of period
Notes	Sample calculation: no Ethics approval: no Comments from trial authors A limitation of this study is that neuropsychological functioning (e.g. intellect, ability, memory, visual perceptual functioning) was not measured in all children All children with MD had substantially impaired motor skills and "soft neurological signs" such as mixed laterality, mirror or overflow movements or choreiform movements Key conclusions of trial authors Children with ADHD‐MD were more likely to have severe ADHD combined type and other neurodevelopmental and behavioural problems Both groups of children had a linear dose response to medication (placebo, low, high), and no evidence was found of a group‐by‐dose interaction or an overall group effect at home or at school Comments from review authors IQ not reported 4 children withdrew from the trial as the result of adverse reactions ‐ all taking HD‐MPH Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: yes Funding source: not declared Email correspondence with trial authors: April 2013. We received from trial authors the full dataset in Statistical Package for the Social Sciences(SPSS)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomly assigned
Allocation concealment (selection bias)	Low risk	Only the clinical pharmacist knew the sequence of phases
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Capsules of medication and placebo were made and dispensed as described by Barkley (1988). Tablets were crushed and placed within orange opaque gelatin capsules. Capsules disguised the taste of MPH and lactose placebo
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Triple‐blind
Incomplete outcome data (attrition bias) All outcomes	High risk	14 of the 63 trials were excluded from the analysis because of inadequately completed outcome measures. 4 of the 14 children did not complete the trial because of adverse reactions to medication (e.g. irritability, headache, stomachache). These children received HD medication in the first trial interval Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias)	Unclear risk	No protocol was published