Acceptance of a New Voice Prosthesis | 197 8 3) Visual Analogue Scale Voice (VAS Voice) A VAS score for effort to speak, where 0 is the most effort to speak they could imagine, and 100 is the least effort to speak. Voice evaluation The Roland Edirol (Roland, Osaka, Japan) voice recorder was used for voice recording and assessment16. Voice recordings included reading aloud a text, producing a sustained /a/ at a normal pitch, and as low, high, soft and loud as possible. During both meetings questionnaires were filled in by the participant. Secondary outcome measures Voice recordings were analyzed and scored for intelligibility trough the objective Acoustic Voice Quality Index (AVQI) method17. The AVQI score gives a representation of the voice quality and is scored from 0-10. A score < 2.95 is considered as having a nonpathologic voice. Note: The AVQI is validated, but not for laryngectomized patients18, but has shown to be useful to evaluate TE-speech19. Subjective voice quality and effort to speak ratings were done blinded by two experienced speech-language pathologists (SLP). Voice samples were scored from 0-10, where 0-5.5 is rated as not sufficient, 5.5-8 acceptable and 8-10 good. Maximum phonation time (MPT, in seconds) and loudness (loudest minus softest /a/ in dB, 90 and 50 percentile, respectively) are compared for both VPs. Incidence and severity of reported problems and the comparison of the recorded voice assessments with their regular VP and PVHP are taken as secondary endpoints. Device life and leakage of VPs is noted. Long-term study follow up Subjects participating in the long-term study were monthly contacted regarding side-effects. This could be through calling, email or during a regular check-up in the hospital. After device failure the PVHPs the questionnaire regarding acceptance was filled in and the PVHPs were investigated for reasons of failure. Statistical analyses Statistical analysis of the collected data was performed with SPSS 27.0 (SPSS Inc., Chicago, IL, USA). Cross tabulations were used to compare the baseline and followup questionnaires. When suitable, the mean, median, standard deviations, range and variances of the analyzed data were visualized in tables. Because of the descriptive nature of this study, results were not tested for significance. The Two Way Mixed Intra-
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