Wallace 1994.
Study characteristics | ||
Methods | Double‐blind, single‐participant, randomised, cross‐over trial:
Conducted in 11 hospitalised children with ADHD |
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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
Exclusion criteria
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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 |
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Outcomes |
ADHD symptoms
Serious AEs
Non‐serious AEs
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Notes | Sample calculation: not stated Ethics approval: not stated Comment from trial authors
Key conclusions of trial authors
Comment from review authors
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 |
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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." |