Tirosh 1993a.
Study characteristics | ||
Methods | 16‐day, double‐blind, cross‐over, counterbalanced trial with 2 interventions:
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Participants | Number of participants screened: not stated Number of participants included: 20 (16 boys, 4 girls) Number of participants followed up: 20 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐III (ADD 30%, ADHD 70%) Age: mean 9.3 years (range 7‐12) IQ: mean 102 (SD 11) MPH‐naive: 100% Ethnicity: not stated Country: Israel Setting: outpatient clinic Comorbidity: no Comedication: no Other sociodemographics: middle (12), upper‐middle (5) and low (3) socioeconomic status of parents Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 2 possible drug condition orders of MPH and placebo MPH dose range: 0.3 mg/kg ‐0.5 mg/kg Administration schedule: twice daily Duration of each medication condition: 8 days Washout before trial initiation: no (participants were MPH‐naive) Titration period: no Treatment compliance: parents were asked to bring their packages of tablets back for pill count; no data |
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Outcomes |
ADHD symptoms
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Notes | Sample calculation: no Ethics approval: yes Key conclusions of trial authors
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: none Email correspondence with trial authors: August 2013. Trial author stated that data were discarded (Ramstad 2013d [pers comm]). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation with a table of random numbers |
Allocation concealment (selection bias) | Low risk | Look‐alike placebo tablets were supplied by the hospital pharmacy and were similarly administered |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | No protocol available |