Wodrich 1998.
Study characteristics | ||
Methods | 3‐week cross‐over trial with 3 interventions:
Phases
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Participants | Number of participants screened: 123 ("treated in the clinic") Number of participants included: 57 (47 boys, 10 girls) Number of participants followed up: 57 Number of withdrawals: 66. Away on summer vacation (n = 30), teacher failed to complete all rating forms (n = 29), teacher marked 2 values indicated on a single dimension (n = 3), adverse medication side effect (n = 2), dropped out before child’s medication trial was completed (n = 2) Diagnosis of ADHD: DSM‐III‐R Age: mean 8.5 years (SD 2.1; range 6‐14) IQ: not stated MPH‐naive: not stated Ethnicity: white "Anglo" 54 (95%), Hispanic 3 (5%) Country: USA Setting: outpatient clinic Comorbidity: not stated Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 2 possible drug condition orders (5 mg MPH or 15 mg MPH) and placebo Mean MPH dosage: 10 mg/d, 30 mg/d and placebo Administration schedule: twice/d at 8:00 am and 12:00 pm Duration of each medication condition: 1 week Washout before trial initiation: approximately 20 h (lunchtime until "immediately before school" the next day) Titration period: not stated Treatment compliance: not stated Number of withdrawals: 2. Parents dropped out of the trial before their child’s medication trial was completed |
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Outcomes |
ADHD symptoms
Serious AEs
General behaviour
Non‐serious AEs
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Notes | Sample calculation: not stated Ethics approval: not stated 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: yes Funding source: not declared Email correspondence with trial authors: June 2014. We obtained supplemental information from trial authors. We contacted trial author to ask for missing data, but s/he was not able to supply the data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Subjects then underwent a three‐week, triple‐blinded, cross‐over medication trial consisting of placebo, 5 mg, and 15 mg of MPH dose twice a day (immediately before school and at lunchtime)" (p 83); "Order of administration was counterbalanced so that equivalent numbers of children received each sequence" (p 83) |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Subjects then underwent a three‐week, triple‐blinded, cross‐over medication trial consisting of placebo, 5 mg, and 15 mg of MPH dose twice a day (immediately before school and at lunchtime). Each drug condition lasted 7 days (Thursday through Wednesday)" (p 83); "Doses were prepared and packaged for the three week trial by a licensed pharmacist who split MPH tablets and placed them with lactose into re‐sealable capsules. The placebo dose consisted of lactose‐filled capsules only. Equivalent numbers of capsules (three) were dispensed at each dosing time to maintain uniformity and disguise presence/amount of medication, as three capsules were required to encompass the largest dose (15 mg)" (p 83) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "This procedure was followed for three weeks, with the medication code being broken the final week and determination about medication efficacy and decision to continue addressed at that time" (p 84) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |