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. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

Wallace 1994.

Study characteristics
Methods Double‐blind, single‐participant, randomised, cross‐over trial:
  • MPH

  • placebo


Conducted in 11 hospitalised children with ADHD
Participants Number of participants screened: not stated
Number of participants included: 11
Number followed up: 11
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐III‐R (subtype not described)
Age: mean 9 years 5 months (range 4‐13 years)
IQ: not stated
MPH‐naive: not stated
Ethnicity: not stated
Country: USA
Setting: inpatient
Comorbidity type: not stated
Other sociodemographics: none
Inclusion criteria
  • Children diagnosed with ADHD who were hospitalised at a psychiatric hospital


Exclusion criteria
  • Not stated

Interventions Participants were randomly assigned to 1 of 2 conditions: MPH and placebo on a daily basis
Mean MPH dosage: not stated
Administration schedule: daily
Duration of each medication condition: MPH 2‐7 days, placebo 3‐6 days
Washout before trial initiation: not described
Medication‐free period between interventions: none
Titration period: "Prior to trial commencement, all participants were treated with MPH for a period long enough to determine the dose believed to have optimal effectiveness and minimal side effects"
Treatment compliance: not described
Outcomes ADHD symptoms
  • Abbreviated CTRS (15‐item): rated by teachers and by day and night nursing staff


Serious AEs
  • Side effects mentioned but not reported


Non‐serious AEs
  • Side effects mentioned but not reported

Notes Sample calculation: not stated
Ethics approval: not stated
Comment from trial authors
  • Assigning highly consistent rates would reduce variance in measurements


Key conclusions of trial authors
  • n‐of‐1 trial is useful for evaluating the effectiveness of MPH in individual patients with ADHD

  • Short duration of MPH action allows for multiple cross‐over trials over a brief time


Comment from review authors
  • Data are not reported in a suitable form for meta‐analysis; therefore we could use no data from this trial


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes, see titration before randomisation
Any withdrawals due to AEs: no
Funding source: The Veterans Administration Medical Center, Vermont
Email correspondence with trial authors: we could find no contact information; therefore, we could not get additional data through personal email correspondence with trial authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequence was determined by "coin toss method"
Allocation concealment (selection bias) Unclear risk Allocation concealment not described
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk "After completion of each trial, the treatment code was broken"
Method of blinding not described
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias)
All outcomes Low risk All data appear to have been reported.
Selection bias (e.g. titration after randomisation → exclusion): no, but trial length was changed according to MPH response
Selective reporting (reporting bias) High risk Protocol not identified
"Also trial length increased as effect size decreased, implying that if clinical effects were unconvincing, the trial was extended. The trials examined here did have trial length designated at commencement by the treating psychiatrist (generally 10 days). However, trials were extended, if after the predetermined number of days, the graphed data appeared equivocal."