Brown 1988.
Study characteristics | ||
Methods | 8‐week, double‐blind, randomised, cross‐over trial with 4 interventions:
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Participants | Number of participants screened: not stated Number of participants included: 11 (all boys) Number of participants followed up: 11 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐III (subtype not stated) Age: mean 13 years, 7 months (range 12 years and 10 months‐14 years and 10 months) IQ: full‐scale mean 92.91 (range 86‐104) MPH‐naive: not stated, but none of the participants had been treated with stimulants during the year preceding the trial Ethnicity: African American (100%) Country: USA Setting: outpatient clinic Comorbidity: CD, socialised aggressive (45%) Comedication: no Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to possible drug condition orders: Interventions (mean dosage)
Mean MPH dosage: MPH low (4.38 mg), medium (12.55 mg), high (21.28 mg) Administration schedule: twice daily; morning and noon Duration of each medication condition: 2 weeks Washout before trial initiation: none (but no stimulant treatment for the past year) Titration period: none Treatment compliance: compliance was determined to be satisfactory |
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Outcomes |
ADHD symptoms At the end of each 2‐week trial, parents and teachers completed the following rating scales
Non‐serious AEs
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Notes | Sample calculation: no Ethics approval: yes; Institutional Review Board (IRB) at Emory University Key conclusion of trial authors
Comment from trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Withdrawals due to AEs: no Funding source: Biomedical Research Support Grant Program, Division of Research Resources, NIH and Emory University Research Email correspondence with trial authors: October 2013. We received from trial authors additional information about ethics approval, planned outcomes and participants followed up. Unfortunately, it was not possible for trial authors to provide other data that we needed because the trial was conducted many years ago, and trial authors no longer had the data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Drug order was randomly assigned across participants; no further description |
Allocation concealment (selection bias) | Low risk | All medication was prepared in identical capsules by hospital pharmacists. Medication was dispensed in dated envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All medication was prepared in identical capsules by hospital pharmacists. Medication was dispensed in dated envelopes. Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Low risk | Researchers administered all measures that were proposed and reported these data in the published report |