Summary of findings 3. Porter 2020: armodafinil compared with placebo for fatigue in high‐grade glioma.
| Armodafinil (150 mg and 250 mg) compared with placebo for fatigue | ||||||
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Patient or population: people with primary brain tumour Settings: hospital, outpatient Intervention: armodafinil (150 mg and 250 mg) Comparison: placebo | ||||||
| Outcomes | Group comparisons | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | ||
| Placebo | Armodafinil 150 mg | Armodafinil 250 mg | ||||
| Fatigue Brief Fatigue Inventory (number of participants with an improvement in 2 points from baseline at 8 weeks (%)) | 29 (29.9%) | 27 (27.8%) | 29 (28.2%) | 297 (1) | ⊕⊕⊝⊝ Lowa | Higher scores indicate higher fatigue. |
| Cognition Symbol Digit Modalities Test (median (range)) | 0.0 (–3.4 to 4.9) | 0.0 (–1.6 to 2.5) | 0.3 (–3.4 to 2.5) | 180 (1) | ⊕⊕⊝⊝ Lowa | Higher scores indicate better performance. |
| Quality of life Linear Analogue Self Assessment (median (range)) | 2.0 (–15.0 to 27.0 | 4.0 (–32.0 to 26.0) | 3.0 (–16.0 to 27.0) | 232 (1) | ⊕⊕⊝⊝ Lowa | Higher scores indicate better quality of life. |
| Adverse events Grade 3 or higher (number of participants (%)) | 3 (2.8%) | 6 (5.5%) | 8 (7.3%) | 328 (1) | ⊕⊕⊝⊝ Lowa | — |
| GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: we are very uncertain about the estimate. | ||||||
aDowngraded two levels; there was low‐certainty evidence due to the level of unclear risk of bias relating to selection, detection and attrition.