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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

Dittmann 2014.

Methods An observational prospective cohort study of methylphenidate use for 12 months
Participants Number of participants screened: not stated
Number of participants included: 247 in stimulant group (short‐ or long‐acting methylphenidate)
Number of participants followed up: 191
Number of withdrawals: 56.
 Diagnosis of ADHD: ICD‐10 (subtype: F90.0 (74.9%), F90.8 (0.8%), F98.8 (8.9%)). DSM‐IV (subtype: combined (8.1%), inattentive (4.9%), hyperactive/impulsive (2.0%), combined and ODD (0.4%))
 Age: mean: 9.3 (SD 2.4) years (range 6‐16)
 IQ: low IQ (70‐84) 19 (7.7%), normal IQ (85‐114) 197 (79.8%), high IQ (115‐129) 29 (11.7%), very high IQ (> 129) 2 (0.8%)
Sex: 179 males, 68 females
Methylphenidate‐naïve: 100%
 Ethnicity: not stated
Country: Germany
 Comorbidity: conduct disorder (14.6%), ODD (13%), anxiety disorder (5.7%), depression (4.9%), tic disorder/Tourette (4.1%), other (10.1%))
Comedication: 239 (96.8%) received no concomitant medication
 Sociodemographics: nuclear family (66.8%), 1 biological parent, 1 step‐parent (13.8%), single mother (13.8%), foster parents (0.4%), adoptive parents (1.2%), single father (0.8%), supervised living arrangement (0.8%), family members other than parents (1.2%), unknown (1.2%)
Inclusion criteria

  1. Medication‐naïve child and adolescent outpatients

  2. Aged 6‐17 years

  3. A diagnosis of ADHD according to ICD‐10 or DSM‐IV criteria

  4. Newly initiated on medication approved for the treatment of ADHD in Germany
Interventions Methylphenidate type: any
Mean methylphenidate dosage: 0.37 (SD 0.23) mg/kg
Administration schedule: not stated
Duration of intervention: 12 months
Treatment compliance: 178 (74.2%) had a PCSR (Pediatric Compliance Self‐Rating instrument) score ≥ 5 at every visit
Outcomes Adverse events were analysed for patients on initial monotherapy only
 Adverse effects were rated at baseline, end of week 1, 2, months 1, 3, 6, 9, and 12
Notes Sample calculation: not stated
Ethics approval: the study was approved by the responsible Ethics Committee (ERBat Medical Faculty Mannheim, University of Heidelberg, Germany)
Funding: research was funded by Lilly DeutschlandGmbH, Bad Homburg, Germany, and by Eli Lilly & Co., Indianapolis, USA
 Vested interests/authors' affiliations: not stated
 Key conclusions of the study authors: all outcome parameters (effectiveness) considered in this open‐label, non‐interventional trial with respect to ADHD core symptoms, ADHD‐related difficulties, and emotional expression significantly improved over time in children and adolescents with ADHD who were treated with pharmacotherapy (i.e. atomoxetine or psychostimulants) in a naturalistic setting with regard to their degree and time course, which corresponds with the well‐established findings from double‐blind controlled clinical trials
 Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no