Zheng 2011.

Methods	A 6‐week multicentre, prospective, naturalistic, open‐label, pilot study evaluating the effectiveness and safety of osmotic release oral system (OROS) methylphenidate
Participants	Number of participants screened: not stated Number of participants included: 1447 Number of participants followed up: 1154 Number of withdrawals: 293 Diagnosis of ADHD: DSM‐IV (subtype: combined (56.8%), hyperactive‐impulsive (9.8%), inattentive (28.5%), unidentified type (3.4%)) Age: 9.53 (SD 2.35) years old (range 6‐16) IQ: not stated Sex: 1219 males, 228 females Methylphenidate‐naïve: not stated (no current methylphenidate treatment: 1304 (90%)) Ethnicity: Asian (97.8%), others (2.2%) Country: China Comorbidity: no Comedication: not stated Sociodemographics: not stated Inclusion criteria: ADHD according to DSM‐IV Willing to take OROS methylphenidate as the only medicine for ADHD Written informed content from parents/guardians Exclusion criteria: Anxiety disorder, mood disorder, general development disorder, serious depression, schizophrenia Known to be allergic to methylphenidate or other ingredients of the study drug Glaucoma Family history or diagnosed as Tourette syndrome Taking or having taken monoamine oxidase inhibitor in the past 14 days Taking the following drugs such as clonidine, other alpha‐2 adrenergic receptor agonist, tricyclic antidepressants, theocine, bishydroxycoumarin and so on Participating in clinical trials of other drugs Cardiovascular diseases including moderate to severe hypertension, hyperthyroidism History of drug dependence or alcohol dependence Participants with serious gastrointestinal stenosis, dysphagia and other serious somatic diseases During the 6‐week treatment period, participants would be excluded if the following conditions occurred: Unwilling to keep receiving OROS methylphenidate therapy due to poor therapeutic effect, intolerance of adverse events, etc. Serious adverse events related to OROS methylphenidate Violating the study protocol by taking ADHD drugs which are not allowed Other serious somatic diseases judged by investigators occur (the condition that the child is in danger based on the BP measurement at any time was also included) Tic symptoms increase or new serious tic symptoms appear Pregnancy
Interventions	Methylphenidate type: osmotic release oral system (OROS) Methylphenidate dosage: 18, 36 or 54 mg once daily at the discretion of investigators. However, the recommended dosing strategy is: methylphenidate‐naïve: 18 mg; currently receiving 5 mg immediate release methylphenidate 2‐3 times a day: 18 mg OROS methylphenidate; currently receiving 10 mg immediate release methylphenidate 2‐3 times a day or a total daily dose of 40 mg immediate release methylphenidate: 36 mg OROS methylphenidate; and currently receiving 15 mg immediate release methylphenidate 2‐3 times a day or a total daily dose of > 45‐60 mg: 54 mg OROS methylphenidate Doses of OROS methylphenidate could be adjusted between a total daily dose range of 18 and 54 mg after 14 days of treatment by the investigator on the basis of safety and efficacy. At the end of the study 96.8% participants received an OROS methylphenidate dose of 18 mg, 3.1% 36 mg and 0.1% 54 mg Duration of intervention: 6 weeks Treatment compliance: 93.4% of the patients showed good compliance (defined as more than 80% adherence to the prescribed regimen)
Outcomes	Non‐serious adverse events Blood pressure, pulse rate measurement, adverse event review were conducted by the investigator at baseline, week 2, 4 and 6 Parents rated the participant's sleep quality and were asked about the presence of motor and/or verbal tics at baseline, week 2, 4 and 6
Notes	Sample calculation: not stated Ethics approval: not stated Funding: funded by Xi'an Jassen Pharmaceutical Ltd, China Key conclusions of the study authors: this open‐label, naturalistic study provides further evidence of effectiveness and safety of OROS methylphenidate in school‐aged children under routine practice Comments from the study authors: since the patients in this study only received 6‐weeks OROS methylphenidate treatment, the long‐term adverse events such as influence on growth and weight can not be observed. This is a limitation of this study because ADHD patients need long‐term treatment Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes Supplemental information requested through email correspondence with the first author in September 2013. No reply