196 | Chapter 8 Figure 2. Schematics of the PVHP: a) Size information (shaft diameter and length between flanges) b) Prosthesis Hood c) Esophageal Flange d) Tracheal Flange e) Safety Strap f) Radioopaque fluoroplastic Valve Flap g) Prosthesis Shaft h) Radio-opaque fluoroplastic Valve Seat i) Silicon Valve Hinge Primary outcome measures Participants’ acceptance of the PVHP (primary endpoint) is measured with questionnaires, pre and two weeks post using the PVHP (see figure 1). Questionnaires used (details in appendix A); 1) Study specific questionnaires: Acceptance of the PVHP, experiences and maintenance of current VP, comparison of VPs. Multiple choice questions about the experiences using the regular versus new VP, maintenance of the VP and possible side-effects (stickiness of the valve, voice quality, speech), acceptance and preference for a VP. Stickiness of the valve is evaluated in different ways, such as blockage of speech and problems with speech initiation. 2) Voice Handicap Index – 10 (VHI-10) The VHI-10 is a 10-item questionnaire to assess subjective voice quality. It contains ten statements and is used to assess subjective voice quality15.
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