Abikoff 2009.

Study characteristics
Methods	8‐week double‐blind, randomised, placebo‐controlled, cross‐over trial with 2 interventions OROS‐MPH placebo
Participants	Number of participants screened: not stated Number of participants included: 19 (15 boys, 4 girls) Number of participants followed up: 19 Number of withdrawals: none Diagnosis of ADHD: DSM‐IV (combined (42%), hyperactive‐impulsive (0%), inattentive (58%)) Age: mean 10.05 years (SD 1.62, range 8‐13) IQ: mean 107.1 (SD 14.3) Methylphenidate‐naive: 100% Ethnicity: not stated Country: USA Setting: outpatient clinic Comorbidity: ODD (26.3%), anxiety disorder (10.5%), dysthymic disorder (5.3%), CD (5.3%) Comedication: not stated Additional sociodemographics: none Inclusion criteria DSM‐IV criteria for ADHD (combined or inattentive type) Meeting dimensional criteria for ADHD symptom severity on CTRS‐R, long form, defined as a score ≥ 1.5 SD above age and sex norms Impaired OTMP, defined by a mean total score ≥ 1 SD below the norm on the Children’s Organizational Skills Scale ‐ Parent, and the Children’s Organizational Skills Scale ‐ Teacher Score ≥ 80 on the WASI‐II Exclusion criteria Diagnosis of autism, major depression, substance abuse, OCD, PTSD, panic disorder, tic disorders, significant suicidality Lifetime history of psychosis or mania Learning disability according to a school individualised educational plan Taking other CNS medications
Interventions	Participants were randomly assigned to 1 of 2 possible drug condition orders of OROS‐MPH and placebo Mean MPH dosage: 48.3 mg (range 18 ± 54 mg); weight‐based final OROS‐MPH dose was 1.3 mg/kg Administration schedule: not stated Duration of each medication condition: 4 weeks: 2 weeks titration and 2 weeks optimal dose Washout before trial initiation: all were medication‐naive Medication‐free period between interventions: 2 days Titration period: 2 weeks after randomisation Treatment compliance: not stated
Outcomes	ADHD symptoms SNAP, 4th Edition, parent‐rated at baseline, after weeks 1 and 2 (during titration) and at end of treatment (4 weeks) SNAP, 4th Edition, teacher‐rated at baseline, after weeks 1 and 2 (during titration) and at end of treatment (4 weeks)
Notes	Sample calculation: no Ethics approval: trial protocol was reviewed and approved by the University’s institutional review board Comment from trial authors The 4 weeks of OROS‐MPH treatment was relatively brief, and post‐treatment measures were obtained after children had been taking their optimal titration dose for 2 weeks Key conclusion of trial authors OROS‐MPH reduced children’s OTMP deficits, and these improvements were associated with improvement in ADHD symptoms. Some children remained impaired in OTMP even after effective stimulant treatment for ADHD symptoms. These youngsters may require other treatments that target OTMP deficits Inclusion of MPH responders only/exclusion of MPH non‐responders/children who have previously experienced adverse events while taking MPH before randomisation: no Any withdrawals due to AEs: no Funding source: a grant from Ortho‐McNeil Janssen Scientific Affairs to Dr. Abikoff Email correspondence with trial authors: December 2013. No supplemental information provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double‐blind
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Double‐blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	Post‐treatment scores for all 19 trial children were obtained from parents. Because 1 child’s treatment was delayed and ran beyond the end of the school year, teacher data on 18 youngsters were analysed Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias)	Unclear risk	No protocol published