Negative effects of submandibular botulinum neurotoxin A injections on oral motor function in children with drooling due to central nervous system disorders.

AIM: The aims of this study were: (1) to determine the incidence and nature of adverse effects on oral motor function after first injections of botulinum neurotoxin A (BoNT-A) in submandibular glands for excessive drooling in children with central nervous system disorders; and (2) to identify independent predictors of these adverse effects. METHOD: A cohort study involved 209 children (123 males, 86 females, aged 4-27y, median 8y 4mo), who received submandibular BoNT-A injections for drooling. Adverse effects were categorized into swallowing, eating, drinking, articulation, and other problems. Univariable logistic regression was used to study differences in patients with and without adverse effects. Possible predictors were identified using multivariable logistic regression. RESULTS: Transient adverse effects occurred in 33% of the 209 BoNT-A treatments. Almost 80% of these were mild, versus 8.7% severe. Approximately 54% of the adverse effects spontaneously resolved within 4 weeks; 3% still existed after 32 weeks. A diagnosis of cerebral palsy, higher range of BoNT-A dosage, and a pre-treatment drooling quotient <18% were found to be independent predictors of adverse effects. INTERPRETATION: Before using submandibular BoNT-A injections for drooling, potential adverse effects should be discussed. Oral motor function needs to be monitored, because existing dysphagia may be worsened. The identified clinical predictors could be helpful to optimize patient selection.

Reliability, construct validity and usability of the Eating and Drinking Ability Classification System (EDACS) among Dutch children with Cerebral Palsy.

PURPOSE: To assess the interrater reliability, construct validity and usability of the Eating and Drinking Ability Classification System (EDACS) among Dutch children with Cerebral Palsy (CP) when used by speech and language therapists (SLTs) familiar and unfamiliar with the child's eating and drinking performance and parents. METHODS: Translation was undertaken using the method of Eremenco. Agreement between SLTs and parents when using EDACS was determined by intraclass correlation coefficient (ICC) and linear weighted Kappa (κW). Associations with other functional classification systems including the Dysphagia Management Staging Scale (DMSS) were investigated to determine construct validity by Kendall's tau-b. RESULTS: Thirty-one SLTs classified 149 children (67 girls; mean 10 y, SD 4 y, range 3-21 y) with EDACS. Pairs of SLTs showed good agreement ([ICC] = 0.84; 95% confidence interval [CI] 0.79-0.88; [κW] = 0.71). Eighty-one parents showed good agreement with SLTs (n= 31) as well (ICC = 0.80; 95% CI 0.71-0.87; κW= 0.61). There was a significant and strong positive correlation of EDACS with DMSS (Kendall's tau-b 0.81) supporting its construct validity. Usability of EDACS was generally good. CONCLUSION: The Dutch version of EDACS is reliable and valid, and can be used easily by (familiar and unfamiliar) SLTs and parents of children with CP. Parents and professionals showed a high level of consistency when classifying eating and drinking abilities. EDACS enables uniform and efficient communication about safety and efficiency of functional eating and drinking ability in clinical and research contexts.