Smith 2004.

Study characteristics
Methods	n‐of‐1 randomised, double‐blind, cross‐over trial investigating the effects of MPH (Ritalin) on the disruptive behaviour of a child diagnosed with ADHD. 1‐day antecedent analysis in the clinic followed by an extended school‐based trial, during which participants received MPH or placebo before evaluation Duration: 15 days
Participants	Number of participants screened: not stated Number of participants included: 1 boy Number of participants followed up: 1 Number of withdrawals: none Diagnosis of ADHD: DSM‐IV (subtype: not stated) Age: 11 years IQ: 124 MPH‐naive: no Ethnicity: not stated Country: USA Setting: outpatient clinic Comorbidity: not stated Comedication: not stated Other sociodemographics: none Inclusion criteria Not stated Exclusion criteria Not stated
Interventions	Participant was randomly assigned to 1 of 2 possible drug condition orders of (20 mg/d ) IR‐MPH and placebo Outpatient clinic setting, duration 1 day: ingestion of 20 mg MPH or placebo 45 min before evaluation (randomised) Cross‐over 4 h later followed by 2nd evaluation School setting: 15 days (3 school weeks) Administration schedule: once daily, mornings, 45 min before 1st evaluation Medication‐free periods: on weekends; a total of 9 days with medication and 6 days without, randomly assigned throughout the trial period Titration period: no Washout period before trial initiation: none other than weekends Treatment compliance: not stated
Outcomes	ADHD symptoms ADHD‐RS‐IV ‐ School Version (18 items): completed by the teacher and an independent observer in the classroom. Classroom assessments were conducted within normal classroom activities in the morning (first 4 h of school). Mean inter‐rater reliability 79% (range 56%‐100%)
Notes	Sample calculation: no Ethics approval: not stated Comments from trial authors A major problem with single data point analyses is the difficulty involved in generalising outcomes to other settings and times Another difficulty involved inclusion of only 1 participant. However, the objectivity of clinic data in combination with checklist outcomes provides generalisable results, which reduces some of these limitations Key conclusion of trial authors The investigation suggests that the 1‐day antecedent analysis procedure could be used as an initial evaluation of the use of MPH (Ritalin) 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: not declared Email correspondence with trial authors: October 2013. We received from trial authors supplemental information regarding diagnostic criteria
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A third party, who was not involved in the clinical procedure, determined the selection of actual medication packs
Allocation concealment (selection bias)	Low risk	A third party, who was not involved in the clinical procedure, determined the selection of actual medication packs
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	A third party, not involved in the clinical procedures, determined the selection of actual medication packs. Thus, people conducting the direct evaluation were blinded to all medication manipulations (i.e. the child, parents, therapists and data collectors). However, no description was provided about whether medication and placebo pills were identical. "Prior to clinical assessment, two packets of medication were provided to the participant's parent. One package contained 20 mg of Ritalin and the other package contained a placebo"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	A third party, who was not involved in the clinical procedure, determined the selection of actual medication packs. Thus, people conducting the direct evaluation were blinded to all medication manipulations (i.e. the child, parents, therapists and data collectors)
Incomplete outcome data (attrition bias) All outcomes	Low risk	No Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias)	Unclear risk	No protocol identified and no email from trial author