88 CHAPTER 4 METHODS Study design Patients who had undergone 2-DL to reduce anterior drooling were retrospectively screened for inclusion, and the primary aimof the study was to evaluate predictors of 2-DL treatment success. All patients were seen in the outpatient saliva control clinic at the Radboud University Nijmegen Medical Centre where patient characteristics and measurements were prospectively obtained by specifically trained Speech and Language Therapists (SLTs). Participants Patients aged 8 years or older, with cerebral palsy or another non-progressive neurodevelopmental disability, and anterior drooling treated with 2-DL between July 2006 and December 2017 were eligible for inclusion. The exclusion criteria were Drooling Severity (never(1), mild(2), moderate(3), severe(4), profuse(5); DS) Score ≤ 2 in combination with Drooling Frequency (no(1), occasional (2), frequent(3), constant (4); DF) score ≤ 1 indicating mild or absent drooling, recent (<6 months) glandular Botulinum Neurotoxin A (BoNT-A) injection, and simultaneous alternative treatment for drooling. Furthermore, we excluded patients with missing values for both Visual Analog Scale (VAS) and Drooling Quotient (DQ) at baseline or 32 weeks follow-up (because it was not possible to calculate 32 weeks treatment success). Patients were excluded from the primary analyses when there were missing values for the dependent or independent variables. We did not impute missing data. The study was conducted in accordance with the national and international ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. The regional committee on Research Involving Human Subjects approved the study. Caregivers informed consent was given before each intervention. Procedures 2-DL was performed under general anesthesia in an outpatient setting. At the beginning of the procedure, the floor of the mouth was infiltrated with 1% lidocaine with 1:100.000 epinephrine. Subsequently, the floor of the mouth was incised
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