Summary of findings 1. High versus low stimulation for focal seizures.
High versus low stimulation for focal seizures | ||||||
Patient or population: people with focal seizures Settings: outpatients Intervention: high stimulation Comparison: low stimulation | ||||||
Outcomes |
Illustrative comparative risks* (95% CI) For adverse effects (99% CI) |
Relative effect
(95% CI) For individual adverse effects (99% CI) |
No of Participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Low stimulation | High stimulation | |||||
50% reduction in seizure frequency (responders) | 144 per 1000 | 249 per 1000 (163 to 380) | RR 1.73 (1.13 to 2.64) | 373 (4 studies) | ⊕⊕⊕⊝ moderatea | RR > 1 indicates outcome is more likely with high stimulation |
Withdrawals | 10 per 1000 | 26 per 1000 (5 to 130) | RR 2.56 (0.51 to 12.71) | 375 (4 studies) | ⊕⊕⊝⊝ lowa,b | RR > 1 indicates outcome is more likely with high stimulation |
Voice alteration or hoarseness | 251 per 1000 | 545 per 1000 (374 to 796) | RR 2.17 (1.49 to 3.17) | 330 (3 studies) | ⊕⊕⊕⊝ moderatea | RR > 1 indicates outcome is more likely with high stimulation |
Cough | 291 per 1000 | 317 per 1000 (215 to 471) | RR 1.09 (0.74 to 1.62) | 334 (3 studies) | ⊕⊕⊕⊝ moderatea | RR > 1 indicates outcome is more likely on high stimulation |
Dyspnoea | 74 per 1000 | 181 per 1000 (79 to 414) | RR 2.45 (1.07 to 5.60) | 312 (2 studies) | ⊕⊕⊝⊝ lowa,c | RR > 1 indicates outcome is more likely on high stimulation |
Pain | 239 per 1000 | 241 per 1000 (143 to 402) | RR 1.01 (0.60 to 1.68) | 312 (2 studies) | ⊕⊕⊕⊝ moderatea | RR > 1 indicates outcome is more likely on high stimulation |
Paraesthesias | 172 per 1000 | 134 per 1000 (67 to 263) | RR 0.78 (0.39 to 1.53) | 312 (2 studies) | ⊕⊕⊕⊝ moderatea | RR > 1 indicates outcome is more likely on high stimulation |
*The basis for the assumed risk is provided in footnote d. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio. | ||||||
GRADE Working Group grades of evidence High certainty evidence: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty evidence: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty evidence: 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 evidence: we are very uncertain about the estimate. |
aOne study that contributed to this outcome was judged to be at high risk of bias, as it had incomplete outcome data, which could not be analysed by an intention‐to‐treat approach. bWide, imprecise confidence interval of the pooled effect estimate due to low withdrawal rates in the included studies cWide, imprecise confidence interval of the pooled effect estimate due to low event rates in the included studies dAssumed Risk: the event rate in the low‐level stimulation group multiplied by 1000. The event rate is the proportion of the total in which the event occurred.