Soleimani 2017.
Study characteristics | ||
Methods | A 4‐week cross‐over‐trial with 4 arms:
Phases: 3 phases (4‐week cross‐over with focus on ADHD symptoms followed by 1‐week washout period and 2‐week cross‐over with focus on DCD symptoms) |
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Participants | Number of participants screened: 28 Number of participants included: 17 (12 boys, 5 girls) Number of participants followed‐up: 16 Number of withdrawals: 1 Diagnosis of ADHD: DSM‐IV TR (100% combined type) Age: 7 years 6 months (± 18 months) (range 6‐11 years or 6‐12 years) IQ: 96.6 (± 12.5, range 80‐118) MPH‐naive: history of MPH usage, mean 22.9 days (range 0‑90 days) Ethnicity: not stated Country: Iran Setting: outpatient Comorbidity: all participants had DCD. No other comorbidities allowed Comedication: not stated Additional sociodemographics: number of siblings: 1.3 (SD 0.5, range 1‐2) Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 4 possible orders of 3 different doses (0.25, 0.5 or 1 mg/kg/d) of MPH (Ritalin) and placebo for 1 week each Number randomised to each group: not stated Mean medication dosage: not applicable (mean minimal effective dose per day was 17.3 mg (mean 0.85 mg/kg, ± 0.16)) Administration schedule: twice/d, 8:00 and 15:00 Duration (of (each) medication): 3 weeks of MPH with 3 different doses, 1 week of placebo Washout before trial initiation: no Medication‐free period between interventions: no Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
Results were only reported for the MPH intervention and no data have been included in our analysis |
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Notes | Sample calculation: yes. “The sample size was estimated from the previous double‐blind study. We estimated that the recruitment of 13 cases would provide 90% power to detect a significant difference between the effects of treatment on motor performance at a significance of P<0.05.” Ethics approval: yes Comments from trial authors
Key conclusion of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH: no Any withdrawals due to AEs: no Funding source: Guilan University of Medical Sciences Email correspondence with trial authors: August, October and November 2021. We contacted the trial authors for information regarding age of participants and first‐period data through personal email in August, October and November 2021, but no answer was received. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The patients were randomly allocated into one of the 4 groups using a random number generator. |
Allocation concealment (selection bias) | Low risk |
Quote: "The key to the randomization was kept by the pharmacy and randomization was broken only in case of potential adverse events." Comment: no adverse events stated, and no statement of code breaking. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | These drugs were prepared by the Shafa Hospital Pharmacy and placed into similar gelatinous capsules. Drugs were labelled by trial participant number according to the randomisation schedule. Parents and the researchers were blinded to child’s drug condition and dosage. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Parents and the researchers were blinded to child’s drug condition and dosage. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 withdrawal Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Low risk | All outcomes from protocol reported |