Boele 2013.
Methods | Double‐blind randomised placebo‐controlled trial, parallel arm | |
Participants |
Inclusion criteria: aged ≥ 18 years; diagnosed with a histologically confirmed glioma or meningioma; no signs of tumour recurrence in the last 6 months; fatigue self reported > 27 on the Checklist Individual Strength Exclusion criteria: history of psychiatric disease or symptoms; expected adverse interactions between prescribed medications and modafinil; unable to communicate in Dutch Number randomised: modafinil: 20; placebo: 17 Follow‐up: 12 weeks Setting: 3 centres in The Netherlands |
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Interventions | 2 treatment arms of 6 weeks Arm 1 treatment schedule: Week 1: oral modafinil 200 mg per day taken in divided does (100 mg upon waking, 100 mg at lunch) Week 2‐6: oral modafinil 400 mg per day taken in divided doses (200 mg upon waking, 200 mg at lunch) Week 7: washout period Week 8‐12: matched placebo Arm 2 treatment schedule: Week 1‐6: matched placebo Week 7: washout period Week 8: oral modafinil 200 mg per day taken in divided does (100 mg upon waking, 100 mg at lunch) Week 9‐12: oral modafinil 400 mg per day taken in divided doses (200 mg upon waking, 200 mg at lunch) |
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Outcomes | Fatigue (Checklist Individual Strength) Depression (Center for Epidemiologic Studies Depression Scale) Health‐related quality of life (Medical Outcomes Study Short‐Form Health Survey) Subjective cognitive functioning (Medical Outcomes Study subjective cognitive functioning scale) Objective cognitive functioning (Rey Auditory Verbal Learning Test, Memory Comparison Test, Stroop Colour Word Test, Letter Digit Substitution Test, Concept Shifting Test, Categorical Word Fluency Test, Concept Shifting Test) |
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Notes | Mean imputation used where missing values were present in questionnaires or neuropsychological assessments No corrections for multiple statistical testing carried out |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A pharmacy randomization system was used to assign participants". Confirmed via correspondence |
Allocation concealment (selection bias) | Low risk | "A pharmacy randomization system was used to assign participants". Confirmed via correspondence |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Patients, treating physicians, and researchers were blind to treatment allocation". Confirmed via correspondence |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Patients, treating physicians, and researchers were blind to treatment allocation". Confirmed via correspondence |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear how much imputation may have affected the result as sensitivity analysis was not carried out to determine whether missing data altered the results of the review Similar number of participants dropped out between time points 1 and 2 (modafinil arm; n = 4, placebo arm; n = 3), more participants dropped out of placebo arm (n = 4) than modafinil arm (n = 1) between time points 2 and 3. Mean imputation was used where missing values were present in questionnaires or neuropsychological assessments. Details of adverse events per group confirmed through correspondence with the lead author. Five participants dropped out of the trial due to adverse events while receiving modafinil. Details per participant were:
Two participants dropped out of the trial due to adverse events while receiving placebo. Details per participant were:
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Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | None |