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. 2019 Oct 8;2019(10):CD001408. doi: 10.1002/14651858.CD001408.pub2

Summary of findings for the main comparison. BoNT‐A compared to usual care or physiotherapy in the treatment of lower limb spasticity in children with cerebral palsy: short‐term results.

BoNT‐A compared to usual care or physiotherapy in the treatment of lower limb spasticity in children with cerebral palsy: short‐term results
Patient or population: children with CP
 Setting: short‐term follow‐up (2 to 8 weeks)
 Intervention: BoNT‐A injections into the lower limb muscles
 Comparison: usual care or physiotherapy
Outcomes Anticipated absolute effects* (95% CI) Relative effect (95% CI) Number of participants (studies) Quality of the evidence (GRADE) Comments
Risk with usual care or physiotherapy Risk with BoNT‐A
Instrumented gait analysis (kinematics) (not measured) Not measured in any trial
Observational gait analysis (not measured) Not measured in any trial
Function
 Assessed with: various scales (GMFM total scores and GMFM goal scores)
 Follow‐up: range 2 to 8 weeks The SMD in the intervention group was 0.59 SD higher (0.23 higher to 0.95 higher). 123 (2 RCTs) ⊕⊝⊝⊝
 Very lowa Favours BoNT‐A group (higher functional scores in BoNT‐A group).
Rule of thumb to interpret the magnitude of effect for the SMD: 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988).
Range of motion (passive ankle dorsiflexion)
 Assessed with: goniometry (degrees)
 Follow‐up: range 2 to 8 weeks The mean passive ankle dorsiflexion in the control group ranged from −0.30 to 13.40 degrees. The mean passive ankle dorsiflexion in the intervention group was 8.34 degrees higher (1.19 higher to 15.50 higher). 186 (2 RCTs**) ⊕⊝⊝⊝
 Very lowb **1 study reported on this outcome per lower limb. Favours BoNT‐A group (higher passive ankle dorsiflexion in BoNT‐A group). High statistical heterogeneity
Satisfaction (not measured) Not measured in any trial
Spasticity (ankle plantarflexors)
 Assessed with: various scales
 Follow‐up: range 2 to 8 weeks The SMD in the intervention group was 1.19 SD lower (2.62 lower to 0.24 higher). 186 (2 RCTs***) ⊕⊝⊝⊝
 Very lowb ***1 study reported on this outcome per lower limb. No difference between groups. High statistical heterogeneity. Rule of thumb to interpret the magnitude of effect for the SMD: 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988).
Adverse events Study population 0.37 proportion of AE in the BoNT‐A group (0.08 to 0.66) 206 (5 RCTs) ⊕⊝⊝⊝
 Very lowc AE for all studies (multiple follow‐up times). Favours control group (higher number of AE in BoNT‐A group)
0 per 1000 Not estimable due to the lack of events in the control group
*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).
AE: adverse events; BoNT‐A: botulinum toxin type A; CP: cerebral palsy; CI: confidence interval; GMFM: Gross Motor Function Measure; RCT: randomised controlled trial; SD: standard deviation; SMD: standardised mean difference.
GRADE Working Group grades of evidenceHigh 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.

aDowngraded two levels for several potential sources of bias and one level for imprecision due to the small sample size.
 bDowngraded two levels for several potential sources of bias and one level due to high statistical heterogeneity and imprecision due to the small sample size.
 cDowngraded two levels for several potential sources of bias and high statistical heterogeneity and one level for imprecision, since most studies in this comparison did not report on adverse events.