Kent 1999.

Study characteristics
Methods	Cross‐over trial with 3 interventions: MPH 0.3 mg/kg MPH 0.6 mg/kg placebo Phases: 3‐week, double‐blind, 2‐way cross‐over, long‐term (≥ 12 months) follow‐up
Participants	Number of participants screened: not stated Number of participants included: 50 (38 boys, 12 girls) Number of participants followed up: 43 Number of withdrawals: 13 Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: mean not reported (range 4‐14 years) IQ: "overall normal intelligence" MPH‐naive: not stated Ethnicity: not stated Country: Canada Setting: outpatient clinic Comorbidity: depression (37%), anxiety (37%), learning disability (51%), CD (5%), "psychiatric disorder" (2%), Tourette’s disorder (12%), "other" (23%) Comedication: not stated Other sociodemographics: "Fifteen (30%) live in households that have a family income below the Canadian poverty line ($20,000/y)", 26 "rural", 9 "suburban", 14 "urban". 21 live with 1 biological parent, 24 live with both parents, 4 live with adoptive parents or "guardians" Inclusion criteria ADHD diagnosis 4‐14 years of age English or French speaking Living with carers with whom they had lived for > 6 months Presence of a teacher who could evaluate the child in class Exclusion criteria History of significant developmental delay Previous diagnosis of pervasive developmental disorder Unwillingness of parents and/or school personnel to meet MPH treatment requirements
Interventions	Participants were randomly assigned to different possible drug condition orders of 0.3 mg/kg MPH and 0.6 mg/kg MPH and placebo Mean MPH dosage: not stated Administration schedule: each new condition started on a Saturday morning (to allow parents’ observation/evaluation on weekend) Capsules given at 8:00 am and 12:00 pm. Conners' administered at baseline and on the last day of each week. A 30‐min semi‐structured follow‐up interview was conducted ≥ 12 months after completion of the trial Duration of each medication condition: 1 week Washout before trial initiation: not stated Medication‐free period between interventions: 12:00 pm to 8:00 am the following day Titration period: none Treatment compliance: not stated
Outcomes	ADHD symptoms Conners' Parent Questionnaire: baseline and on the last day of each week Conners' Teacher Questionnaire: baseline and on the last day of each week Non‐serious AEs Weekly reporting of side effects by parents and teachers. No use of standard side‐effects questionnaire
Notes	Sample calculation: not stated Ethics approval: yes; the Research Ethics Board of the IWK Grace Health Centre approved the protocol Comments from trial authors "We found the MPT to be helpful, practical, and definitive for families of children with attention‐deficit/hyperactivity disorder to making a decision about medication use" "Regardless of the outcome, it was important for families to complete the MPT to understand, for their own child, the effect of methylphenidate on the child’s behaviour and the presence of any side effects" Key conclusion of trial authors "An 'N of 1' MPT was easily performed and permitted families to decide whether to use methylphenidate for long‐term treatment of attention‐deficit disorder or attention‐deficit/hyperactivity disorder. Regardless of methylphenidate use or lack of use, the condition of all of these children was improved at follow‐up" Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: yes, "No family found the MPT difficult, but 6 trials were incomplete, usually because of side effects” Funding source: Ms Kent was a summer medical student supported in part by the IWK Grace Research Foundation, Halifax, NovaScotia, and by the Pharmaceutical Manufacturers Association of Canada Studentship, Ottawa, Ontario Email correspondence with trial authors: August 2013. We received additional information from trial authors, but they were not able to provide the additional data that we requested
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Once enrolled in the MPT, the non‐blinded hospital pharmacist randomly assigned each child to a particular dosing schedule". "The capsules contained, in random order: placebo of the prescribed dose of MPH (Ritalin) hydrochloride (0.3 mg/kg or 0.6 mg/kg)"
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Families (n = 50) with a child eligible for MPT were given 3 bottles of identical capsules". "The family, teacher, and physician were blinded for the order of medication"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"At the end of each trial the code was broken. The physician evaluated this information and made a clinical inference about the degree of response each week"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not stated Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias)	Unclear risk	No protocol identified