25 Repeated onabotulinum neurotoxin A injections for drooling in children with neurodisability 1 and a visual analogue scale (VAS) before the injection (baseline) and 8 weeks after the injection. The most recent baseline measurement was used in case of multiple assessments. Primary outcomes The drooling quotient and VAS at the 8-week assessment were used as primary outcome variables. Reduction was defined by the baseline minus the outcome at the 8-week assessment. The assessment at 8 weeks was chosen as onabotulinum neurotoxin A injections have shown a maximum effect of clinical reduction in drooling between 2 and 8 weeks.6 A clinically meaningful change (treatment success) was defined as ≥50% reduction in drooling quotient and/or VAS 8 weeks after treatment.4,5,15,16 Treatment success was calculated by either VAS or drooling quotient alone in case of a missing drooling quotient or VAS. The drooling quotient is a direct, observational, semi-quantitative method validated to evaluate anterior drooling.17 It is used as measurement for the severity of drooling by observing actual salivation over a 5- or 10-minute period of time during activity or rest. Both are equally validated procedures, but assessment during activity has been shown to distinguish drooling severity better than during rest.17 In this study, the drooling quotient during activity was used. The type of activity varied from playing with blocks and using electronic devices, and was adjusted based on the child’s abilities and interests. The 5- and 10-minute versions were both accepted as they can be used interchangeably.17 Subjective drooling is assessed by a VAS for severity of drooling. Parents or caregivers are asked to indicate drooling severity on a line ranging from 0 (no drooling) to 100 (being the most severe outcome) for the severity of drooling over the past 2 weeks.18 Secondary outcomes Adverse events documented are described. In addition, the drooling severity and drooling frequency scale are presented in Table S1 (online supporting information).
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