Pelham 2005.

Study characteristics
Methods	8‐day, multi‐centre, double‐blind, randomised, dose‐ranging, cross‐over trial with 2 interventions: MPH transdermal system placebo From a Summer Treatment Program
Participants	Number of participants screened: 36 Number of participants included: 36 (33 boys, 3 girls) Number of participants followed up: 36 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: mean 9.6 years (range 6‐13) IQ: mean 105.3 (SD 18) MPH‐naive: 15 (42%) Ethnicity: white (75%), African American (19%), Hispanic (3%), mixed African American/white (3%) Country: USA Setting: outpatient clinic (summer treatment programme) Comorbidity: not stated Comedication: no; antidepressants were withdrawn from 2 participants before trial enrolment Other sociodemographics: parents were manual workers (6%), clerical/sales workers (32%), technicians/semi‐professionals (23%) and executives/major professionals (32%) Inclusion criteria Not stated Exclusion criteria Medical history prohibiting patients from taking stimulants or participating Involvement in Summer Treatment Program activities Skin problems or allergies to ingredients in the patches
Interventions	Participants were randomly assigned to 1 of 8 possible drug conditions of MPH transdermal system and placebo MPH transdermal system dosage: 6.25 cm² (0.45 mg/h), 12.5 cm² (0.9 mg/h), 25 cm² (1.8 mg/h) Administration schedule: once/d (at 6:00 am and 7:00 am). Application sites were alternated each day between left and right hips Duration of each medication condition (crossed with time of application): 1‐day; patch worn for ≥ 12 h/d Duration of trial: 8 days Washout before trial initiation: no Medication‐free period between interventions: no Titration period: none Treatment compliance: 100%. Parents returned patches and dosing records to the trial site
Outcomes	ADHD symptoms IOWA CRS and Abbreviated CRS were rated daily by parents, counsellors and teachers Non‐serious AEs Pittsburgh Side Effects Rating Scale completed daily by parents, counsellors and teachers Any other AEs that the child experienced were recorded Skin irritation at application sites rated each day by parents for skin reactions or irritations before application, before removal and the following morning. Presence of erythema: none (0), very slight (1), well defined (2), moderate (3) or severe (4). Presence of discomfort: none (0), mild (1), moderate but tolerable (2) or severe (3)
Notes	Sample calculation: yes (36‐48) Ethics approval: yes; institutional review board at each site approved the trial Comments from trial authors No children experienced a skin reaction severe enough that the study physician recommended discontinuing the patch Limitations: short study duration, no controlled time‐course evaluation Key conclusions of trial authors MPH transdermal system produced significant effects that were similar to those previously reported with comparable MPH doses Substantial effect of application time on total daily functioning not apparent in this setting; additional controlled time‐course studies will be necessary to fully evaluate the question of morning onset Further study will be necessary to establish long‐term efficacy and safety of the MPH transdermal system Comment from review authors Families received monetary compensation to participate Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: no Funding source: Noven Pharmaceuticals. Furthermore, Dr. Pelham was supported by grants from National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse; NIMH and National institute of Neurological Disorders and Stroke Email correspondence with trial authors: February‐March 2014. We attempted to obtain supplemental information regarding randomisation, allocation concealment, washout period and efficacy and safety data from trial authors but without success
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Trial sponsor produced random orders and prepared medication kits in numbered containers for each participant
Allocation concealment (selection bias)	Unclear risk	No information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Treatment sequences were concealed until completion of the trial
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Treatment sequences were concealed until completion of the trial
Incomplete outcome data (attrition bias) All outcomes	High risk	Evaluable participant data were analysed. As the result of record‐keeping difficulties at 1 site, efficacy data were excluded for 5 participants Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias)	Unclear risk	No protocol found