Summary of findings for the main comparison. Methylphenidate for children and adolescents aged 18 years and under with attention deficit hyperactivity disorder (ADHD): adverse events.
| Methylphenidate for children and adolescents aged 18 and under with attention deficit hyperactivity disorder (ADHD): adverse events | |||||
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Patient or population: children and adolescents aged 18 years and under diagnosed with ADHD Settings: outpatient clinic, inpatient hospital ward and register data Intervention: methylphenidate Comparision: control or no control | |||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) at follow‐up | Quality of the evidence (GRADE) | |
| Risk with control or no control | Risk difference with Methylphenidate | ||||
| Comparative studies | |||||
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Serious adverse events Measured by: proportion of serious adverse events (total) Average study duration (range): not stated |
12 per 1000 | 4 more per 1000 (2 more to 7 more) |
RR 1.36 (1.17 to 1.57) | 72,005 (2 studies) | ⊕⊝⊝⊝ Very lowa |
| Non‐comparative studies | |||||
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Serious adverse events Measured by: proportion of any serious adverse events Average study duration (range): 4.7 months (14 days to 21 months) |
1.20% (0.70% to 2.00%) | — | 162,422 (51 studies) | ⊕⊝⊝⊝ Very lowb | |
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Withdrawal of methylphenidate due to serious adverse events (non‐comparative cohort studies) Measured by: proportion of participants withdrawn from treatment Average study duration (range): 7.9 months (1 month to 37 months) |
1.20% (0.60% to 2.30%) | — | 1173 (7 studies) | ⊕⊝⊝⊝ Very lowb | |
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Withdrawal of methylphenidate due to adverse events of unknown severity Measured by: proportion of participants withdrawn from treatment Average study duration (range): 4.6 months (21 days to 36 months) |
7.30% (5.30% to 10.0%) | — | 3708 (22 studies) | ⊕⊝⊝⊝ Very lowb | |
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Non‐serious adverse events Measured by: proportion of any non‐serious adverse events Average study duration (range): 5.99 months (1 day to 41 months) |
51.2% (41.2% to 61.1%) | — | 13,978 (49 studies) | ⊕⊝⊝⊝ Very lowb | |
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Withdrawal of methylphenidate due to non‐serious adverse events Measured by: proportion of participants withdrawn from treatment Average study duration (range): 5.60 months (0.6 months to 41 months) |
6.20% (4.80% to 7.90%) | — | 7142 (37 studies) | ⊕⊝⊝⊝ Very lowb | |
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Withdrawal of methylphenidate for unknown reasons Measure by: proportion of participants withdrawn from treatment Average study duration (range): 6.13 months (1 day to 36 months) |
16.2% (13.0% to 19.9%) | — | 8340 (57 studies) | ⊕⊝⊝⊝ Very lowb | |
| *The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; ROBINS‐I: Risk Of Bias In Non‐randomised Studies ‐ of Interventions; RR: risk ratio | |||||
| GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect. | |||||
aOutcome assessed at critical risk of bias using the ROBINS‐I. Consequently, we downgraded the quality of the evidence by 3 levels due to study limitations. bOutcome not critically assessed with ROBINS‐I due to lack of control group. However, due to the nature of the studies and the risk of confounding, we considered the studies to be at critical risk of bias. Consequently, we downgraded the quality of the evidence by 3 levels due to study limitations.