Kordon 2011.

Methods	A prospective, open‐label, single arm, non‐interventional cohort study of osmotic release oral system (OROS) methylphenidate use for 12 weeks after abrupt switching from immediate release (IR) methylphenidate
Participants	Number of participants screened: 616 Number of participants included: 598 (ITT population) Number of participants followed up: 579 Number of withdrawals: 110 (18.4%) Diagnosis of ADHD: ICD‐10 (subtype: F90.0 (63.5%), F90.1 (37%), F90.8 (2%), F90.9 (2.8%), F98.8 (9.9%)). Age: mean 10.9, range 6‐17 years old IQ: not stated Sex: 507 males, 91 females Methylphenidate‐naïve: 8.8% Ethnicity: not stated Country: Germany Comorbidity: 33.3% (subtype: conduct disorder (23.4%), oppositional defiant disorder (16.6%), anxiety disorder (3.8%), obsessive compulsive disorder (1.5%), substance abuse (0.8%) Comedication: not stated Sociodemographics: not stated Inclusion criteria Confirmed diagnosis of ADHD (ICD‐10) Medically indicated switch from IR MPH to OROS MPH due to insufficient efficacy and/or tolerability, and planned by treating physician Age 6‐18 years old
Interventions	Methylphenidate type: osmotic release oral system (OROS) Methylphenidate starting dose: 29.5 SD 12 mg/day (range: 18‐108 mg/day, median 36 mg/day) Methylphenidate final dose: 33.5 SD 13.2 mg/day (range: 18‐108 mg/day, median 36 mg/day) Administration schedule: once daily Duration of intervention: 12 weeks Treatment compliance: 0.8% of ITT non compliant
Outcomes	3 visits in clinic: baseline, after 1 month of treatment, after 3 months of treatment, or on premature termination Adverse events: World Health Organization ‐ Adverse Reactions Terminology (WHO‐ART). Rated throughout the study. Spontaneous reporting. ITT safety population included only those who had ≥ 1 post‐baseline efficacy measurement Sleep quality and appetite: rated at each visit using a 5‐point scale (1 = very good, 5 = very bad) Vital signs: blood pressure and heart rate. Measured at every visit Body weight: measured at baseline and after 3 months of treatment
Notes	Sample calculation: no Ethics approval: independent ethics committee (Freiburg, Germany) Funding/vested interests: editorial assistance funded by Janssen‐Cilag Authors' affiliations: BS is employed by Janssen‐Cilag, KR is a consultant working for GEM, and paid by Janssen‐Cilag Key conclusions of the study authors: in this naturalistic setting, transitioning from IR‐MPH to OROS‐MPH, in patients who showed previously insufficient response and/or poor tolerability, was successful. OROS methylphenidate was generally safe and well tolerated. Children/adolescents with ADHD who were switched from IR methylphenidate to OROS methylphenidate experienced clinically relevant improvements in symptoms, HRQoL and social functioning Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: unclear Supplemental information requested from the study authors twice in July 2014 with no reply