Stevens 2010.

Methods	A cross‐sectional study of youths treated with high‐dose osmotic release oral system (OROS) methylphenidate
Participants	Number of participants screened: not stated Number of participants included: 17 Diagnosis of ADHD: DSM‐IV (subtype: combined 11, inattentive 6) Age: mean 16.2 years old (range 11‐20) IQ: not stated Sex: 13 males, 4 females Methylphenidate‐naïve: no Ethnicity: white 88%, Native American 12% Country: USA Comorbidity: depressive spectrum disorders 47%, pervasive developmental disorders 41%, oppositional defiant disorder 41%, bipolar spectrum disorders 29%, fetal alcohol syndrome 12% Comedication: bupropion (n = 10), SSRIs (n = 8), lithium (n = 5), alpha‐2 agonists (n = 4), atypical antipsychotics (n = 3), lamotrigine (n = 3), trazodone (n = 2), SNRIs (n = 1), oxcarbazepine (n = 1), tricyclic antidepressants (n = 1) Sociodemographics: not stated Inclusion criteria: Children and adolescents Higher than FDA‐approved dose of OROS methylphenidate Diagnosed with ADHD with DSM‐IV criteria Exclusion criteria: 1 patient was excluded because of concerns about medication adherence
Interventions	Methylphenidate type: osmotic release oral system (OROS) Mean methylphenidate dosage: 169 mg/day SD 31 (range: 126‐270) Administration schedule: not stated Duration of intervention: not stated, but ≥ 2 weeks stabilised on same dose Treatment compliance: not stated
Outcomes	Heart rate, systolic blood pressure, and diastolic blood pressure measured No adverse events or adverse cardiovascular outcomes were reported
Notes	Sample calculation: not stated Ethics approval: yes Funding/vested interest: the data analysis of this research was funded by institutional funds from the Pediatric Psychopharmacology Unit at Massachusetts General Hospital Authors' affiliations: George is a speaker for McNeil, Shire, Novartis and Lilly, consultant for McNeil and Shire. Wilens receives grant support from Abbott, McNeil, Lilly, Merck and Shire, is a speaker for Lilly, McNeil, Novartis and Shire, is a consultant for Abbott, McNeil, Lilly, NIH, Novartis, Merck and Shire Key conclusions of the study authors: high‐dose OROS methylphenidate used in combination with other medications, was not associated with either unusually elevated plasma methylphenidate concentrations or with clinically meaningful changes in vital signs Comments from the review authors: requirement to be stabilised on OROS methylphenidate de facto excludes patients with poor or adverse response Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: see above Supplemental information regarding data requested through email correspondence with the authors in June 2014. No reply