Bouffard 2003.
| Study characteristics | ||
| Methods |
Design: Double‐blind, cross‐over trial of placebo versus IR methylphenidate Unit of randomization: individual |
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| Participants |
Location/Setting: not reported
Sample size: 38
Number of withdrawals/dropouts: 8
Sex (with 8 withdrawals/dropouts excluded; n = 30): 24 male and 6 female participants
Mean age: 34 years Inclusion criteria:
Exclusion criteria:
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| Interventions |
Intervention (n = 38): IR methylphenidate
Control (n = 38): placebo Administration: comparison of 2 dosages of IR methylphenidate (10 mg 3 times daily and 15 mg 3 times daily) to each other and to equivalent dosages of placebo. Each dosage was given for 2 weeks. Participants were randomly assigned to start either IR methylphenidate or placebo. Medication was started with a 3‐day lead‐in of increasing dosages, as follows: day 1, 5 mg 3 times daily; day 2, 10 mg 3 times daily; day 3, 15 mg 3 times daily |
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| Outcomes |
Primary outcomes:
Secondary outcomes:
Timing of outcome assessment: 2 weeks |
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| Notes | Study start date: not reported Study end date: not reported Funding source: This research was supported by an Fonds de la Recherche en Santé du Québec (FRSQ) grant for the study of adults with ADHD Conflicts of interest: none disclosed | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "We gave the hospital pharmacy a numbered list indicating a randomly chosen (from a hat) order of medication to start first (either methylphenidate or placebo) and assigned each subject a number. Subjects gave their number to the pharmacist when picking up their prescriptions." |
| Allocation concealment (selection bias) | Unclear risk | Comment: Insufficient information available to permit a judgment. |
| Blinding of participants (performance bias) | Unclear risk | Comment: Insufficient information available to permit a judgment. |
| Blinding of personnel (performance bias) | Unclear risk | Comment: Insufficient information available to permit a judgment. |
| Blinding of outcome assessment (detection bias) Efficacy, Symptoms of ADHD | Unclear risk | Comment: The questionnaires were self‐reported but it is unclear whether masking of the participant was guaranteed |
| Blinding of outcome assessment (detection bias) Harms | Unclear risk | Comment: The questionnaires were self‐reported but it is unclear whether masking of the participant was guaranteed |
| Incomplete outcome data (attrition bias) Efficacy, Symptoms of ADHD | Unclear risk | Comment: The flow of participants randomized and enrolled was not reported |
| Selective outcome reporting Efficacy, Symptoms of ADHD | High risk | Comment: Outcomes of interest were reported incompletely |
| Selective outcome reporting Harms | High risk | Comment: Outcome measurement was self‐reported; it could differ between intervention groups and likely be influenced by knowledge of the intervention received |