Döpfner 2011c.

Methods	A cohort study of methylphenidate use for 4‐6 weeks
Participants	Number of participants screened: not stated Number of participants included: 467 Number of participants followed up: 447 Number of withdrawals: 20 (excluded in intention‐to‐treat analysis, but included in the tolerability evaluation) Diagnosis of ADHD: 48% ICD‐10 diagnosis of ADHD (subtype: not stated), 42% "hyperkinetic disorders which affected their social behavior" (subtype: not stated) Age: mean: 10.7 (2.5) years (range: 6‐17) IQ: not stated, but half of the children were in primary school Sex: 361 males, 106 females Methylphenidate‐naïve: 14% Ethnicity: not stated Country: Germany Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria Age 6‐17 Diagnosed with ADHD Indication for treatment with Medikinet retard Exclusion criteria Patients were excluded if they had any contraindications listed in the summary of product characteristics
Interventions	Methylphenidate type: Medikinet retard (extended release) Mean methylphenidate dosage: 22.6 mg (range: not stated) Administration schedule: once daily Duration of intervention: 4‐6 weeks Treatment compliance: was assessed by prescribing physician. In 57% of cases there was improved compliance after the medication switch; no change was observed in 39%, and compliance deteriorated in 4%
Outcomes	Non‐serious adverse events: 11 items in the paediatric diagnosis system KIDS assesses potential adverse events of the medication In 79 patients, adverse events were recorded by the physician, and these events were described as severe in 13 cases. The most frequent adverse events were appetite disorders, head‐ and stomachache and sleep disorders
Notes	Sample calculation: no Ethics approval: non‐interventional study pursuant to Section 4 sentence 3 and Section 67 AMG (German Medicines Act) Funding/vested interest/authors' affiliations: Prof Döpfner is employed as a consultant to the following companies and receives research funding from these companies: Janssen‐Cilag, Lilly, Medice, Novartis, Shire, UCB. Dr Fischer is an employee of Medice. Ms Ose is participating in studies which are supported by Medice and UCB Any withdrawals due to adverse events: 10 Key conclusions of the study authors: the overall evidence showed that Medikinet retard was well tolerated in routine clinical practice, can be used effectively to treat symptoms of ADHD, can improve compliance to medication and can contribute to a further improvement in symptoms in previously suboptimally treated patients Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: by implication, since treatment would not be indicated for non‐responders Supplemental information regarding data requested from the authors by email in June 2014. No answer received