Bliznakova 2007.
Study characteristics | ||
Methods | 11‐day N‐of‐1 randomised, double‐blind, cross‐over trial with 2 interventions:
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Participants | Number of participants screened: 1 boy Number included: 1 Number of participants followed up: 1 Number of withdrawals: 1 Diagnosis of ADHD: ICD‐10 (predominantly hyperactive type) Age: 15 years IQ: not stated MPH‐naive: no Ethnicity: not stated Country: Germany Setting: not stated Comorbidity: not stated Comedication: not stated Other sociodemographics: 2 parents |
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Interventions | The participant was randomly assigned to MPH and placebo across 11 days Mean MPH dosage: not stated Administration schedule: not stated Duration of each medication condition: the condition was changed daily, but placebo was given for 6 days and MPH for 5 days Washout before trial initiation: not relevant Medication‐free period between interventions: none Titration period: none Treatment compliance: 100% according to Table 7 |
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Outcomes |
ADHD symptoms
Non‐serious AEs
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Notes | Sample calculation: yes Ethics approval: not stated Key conclusion 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: not stated Email correspondence with trial authors: December 2013. Emailed trial author to request information about missing data but received no response. Not possible to use data from this trial |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Low risk | No indication of selective reporting |