134 CHAPTER 6 Nijmegen. The detailed protocols for these procedures have been reported in a previous publication of the same research group.10 There was concealment of allocation from those assigning patients to either BoNT-A or two-duct ligation, until the moment of assignment. All patients were randomized in a 1:1 ratio using an electronic randomizing program. Patients were stratified on the basis of sex, age, presence of cerebral palsy, and Gross Motor Function Classification System (GMFCS) level. Blinding of researchers and hospital staff was not possible owing to the visible difference between the two interventions; therefore, drooling quotient measurements were recorded for subsequent evaluation by a speech and language therapist blinded to treatment allocation. All patients participating in the trial visited our outpatient clinic for measurements at baseline, and at 8 and 32 weeks post-intervention. Patients were evaluated by a speech and language therapist and an ear, nose, and throat consultant at baseline. Measurements at baseline, and at 8 and 32 weeks, were primarily performed by the dedicated speech and language therapist. Two-duct ligation was performed by an ear, nose, and throat consultant and BoNT-A injection was performed by a rehabilitation consultant. According to the trial design, a telephone consultation with an ear, nose, and throat consultant was scheduled after a procedure to assess complaints or complications one week postoperatively. Primary outcomes The incremental cost-effectiveness ratio (ICER) was calculated using the success proportions as themeasure of benefit. This was calculated using themean total cost and the treatment success defined as either a reduction ≥ 50% in drooling quotient or visual analogue scale for the severity of drooling after 32 weeks. This definition is now the standard to determine treatment success in our institution.10–12,14 All baseline and follow-up measurements consisted of an assessment of the drooling quotient and visual analogue scale for severity of drooling. The drooling
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