90 CHAPTER 4 in activity.14 Patients were evaluated while awake and sitting erect, at least 1 hour after eating. Secondary outcomes Secondary outcomes were: 1) VAS for severity of drooling from baseline to 32 weeks. 2) DQ from baseline to 32 weeks. 3) DS and DF from baseline to 32 weeks. 4) Surgical time. 5) Adverse events (AEs). AEs were graded as related or unrelated to the surgical procedure where pain, dysphagia and xerostomia for less than 7 days were considered normal postoperative course.15,8 AE that were potentially life threatening, required prolonged hospitalization, surgical reintervention, or caused permanent damage are defined as SAE. 6) To evaluate whether predictors for objective treatment success (defined as a ≥ 50% reduction in DQ) are similar to predictors for combined treatment success (defined as a ≥ 50% reduction in DQ and/or VAS). Objective treatment success (≥ 50% reduction in DQ from baseline to 32 weeks) served as the primary outcome in previous prediction studies of the same research group. Statistical analyses Clinical variables that are potentially related to treatment success were used in the logistic regression. Logistic regression statistics was used to analyze predictors to treatment success using backward selection. We present a prediction model for the primary outcome. Discrimination is presented as bias-corrected Area Under the Curve (AUC). Internal validation was performed by the bootstrap method (1000 bootstraps). We present the calibration per quintiles as a figure. Goodness of fit was evaluated using a Hosmer-Lemeshow test for quintiles and significance was set at ≤ 0.05 which would indicate a poor fit. We did not perform an external validation.
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