Summary of findings 3. BoNT‐A compared to usual care or physiotherapy in the treatment of lower limb spasticity in children with cerebral palsy: long‐term results.

BoNT‐A compared to usual care or physiotherapy in the treatment of lower limb spasticity in children with cerebral palsy: long‐term results
Patient or population: children with CP Setting: long‐term follow‐up (more than 24 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 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 6 to 24 months	‐	The SMD in the intervention group was 0.34 SD higher (0.33 lower to 1.01 higher).	‐	199 (4 RCTs)	⊕⊝⊝⊝ Very lowa	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).
Range of motion (passive ankle dorsiflexion) Assessed with: goniometry (degrees) Follow‐up: range 6 to 24 months	The mean change in passive ankle dorsiflexion in the control groups ranged from −5.20 to −2.02 degrees (changes from baseline).	The mean passive ankle dorsiflexion in the intervention groups was 6.48 degrees higher (4.42 higher to 8.53 higher).	‐	250 (4 RCTs**)	⊕⊝⊝⊝ Very lowb	**1 study reported on this outcome per lower limb. Favours BoNT‐A group (higher passive ankle dorsiflexion in BoNT‐A group). Note: 3 studies reported this outcome as changes from baseline.
Satisfaction Assessed with: visual analogue scale (scale from 0 to 10) Follow‐up: range 6 to 24 months	The mean satisfaction score in the control group was 6.31.	The mean satisfaction score in the intervention group was 1.57 higher (0.76 higher to 2.38 higher).	‐	24 (1 RCT)	⊕⊝⊝⊝ Very lowc	Favours BoNT‐A group (higher satisfaction scores in BoNT‐A group)
Spasticity (ankle plantarflexors) Assessed with: various scales Follow‐up: range 6 to 24 months	‐	The SMD in the intervention group was 0.77 SD lower (1.13 lower to 0.40 lower).	‐	258 (4 RCTs***)	⊕⊝⊝⊝ Very lowb	***1 study reported on this outcome per lower limb. Favours BoNT‐A group (lower spasticity in BoNT‐A group). Note: 2 studies reported this outcome as changes from baseline. 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	‐	‐	‐	‐	‐	See Table 1
*The risk in the intervention group (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). BoNT‐A: botulinum toxin type A; CI: confidence interval; CP: cerebral palsy; GMFM: Gross Motor Function Measure; RCT: randomised controlled trial; SD: standard deviation; SMD: standardised mean difference.
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.

^aDowngraded two levels for several potential sources of bias and imprecision and one level due to high statistical heterogeneity.
 ^bDowngraded two levels for several potential sources of bias and one level for imprecision, as the unit of analysis in one study was each lower limb.
 ^cDowngraded two levels for several potential sources of bias and one level for imprecision, as this outcome was reported by a single study with a small sample size.