46 CHAPTER 2 randomization sequence stratified by CP or other neurodevelopmental disability, Gross Motor Function Classification System (GMFCS), and sex allowing concealment for the next allocation. In case of withdrawal before the intervention had taken place, new patients were included. Masking. The study was partially blinded: 8- and 32-week follow-up DQ measurements were recorded on video. A separate speech language therapist blinded to therapy allocation measured the DQ using these video recordings which allowed us to determine inter-rater accuracy and check for researcher bias. Thus, only investigators who measured the DQ recorded on video were blinded. Patients, caregivers and investigators were not otherwise masked for treatment allocation. Visits. The follow-upprotocol closelymatches regular care inour SalivaControl clinic. Visits were performed at baseline, 8 and 32 weeks postoperatively for evaluation of the primary and secondary outcome measures. One week after the intervention caregivers were contacted by telephone and asked about complaints and adverse events. Caregivers completed a diary assessing complaints postoperatively. Primary outcome measures. Measurements were made by experienced pediatric speech-language therapists. The primary outcome was: 1. The comparison of 2-DL to BoNT-A for response to treatment at 32 weeks, defined as ≥50% reduction in the DQ or caregivers Visual Analogue Scale (VAS). The DQ, a validated, direct observational, semi quantitative method to assess severity of drooling, reflects the proportion new saliva dripping over the lips over a 5-minute session as observed during activity or rest.17 In this study we report the DQ in activity.19 To increase reliability, measurements take place at least one hour after a meal while awake and sitting erect. The VAS is marked on a 100mm line and reflects severity of drooling over the previous 2 weeks. A score of “100” corresponds to ‘severe drooling’.
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