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. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

Wodrich 1998.

Study characteristics
Methods 3‐week cross‐over trial with 3 interventions:
  • MPH 5 mg, twice daily

  • MPH 15 mg, twice daily

  • placebo


Phases
  • Each drug condition lasted 7 days (Thursday through Wednesday)

  • "No washout period was deemed necessary, given the brief half‐life and absence of carry‐over effects of MPH [methylphenidate]"

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
  • DSM‐III‐R Diagnosis of ADHD, confirmed by a clinical psychologist


Exclusion criteria
  • No primary disorder "better explained the child’s presenting symptoms" (e.g. mood disorder, anxiety disorder, adjustment disorder, pervasive developmental disorder)

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
Outcomes ADHD symptoms
  • Abbreviated Conners' Rating Form

  • School Situations Questionnaire: "As our research concern was to locate tools helpful to school psychologists, we chose to address only the utility of using SSQ. For statistical analysis, scores from zero (no problem) to 9 (severe problem) were entered for each situation" (p 84)


Serious AEs
  • Side Effects Questionnaire


General behaviour
  • Personality Inventory for Children


Non‐serious AEs
  • Side Effects Questionnaire

Notes Sample calculation: not stated
Ethics approval: not stated
Key conclusions of trial authors
  • School Situation Questionnaire ratings improved with MPH treatment in all situations related to task performance (i.e. arriving at school; during individual seatwork, small group activities and lectures) but less so in non‐task or unstructured situations

  • Many change scores were large enough to be clinically meaningful

  • Use of School Situations Questionnaire by school psychologists was discussed as a means of efficiently providing contextual information not available from ADHD dimensional rating scales


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
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