206 | Chapter 8 Discussion This feasibility study found that the short-term acceptance of a newly developed voice prosthesis called ‘PVHP’ was 87%; however, it dropped to 40% after replacement of the PVHP due to device failure. Acceptance is a composed outcome measure, in this study, depending on factors related to the patient, but also on other outcomes such as stickiness of the valve, speech and device lifetime. The difference in acceptance rate at these two time points (short-term versus long-term follow-up) can mainly be explained by the shorter than anticipated device life. The most reported side-effect was blocking of speech due to stickiness of the valve, which is caused by the used material and is a well-known side-effect of the ActiValve, made from the same material11. All patients were able to solve these problems by coughing, brushing the VP and/or reapplying lubrication. ActiValve-users were common with lubricating and thus reported less side-effects compared to the Vega-users. The use of lubrication was not considered a main issue, comparable with the ActiValve11, 13. Surprising, half of the patients rated their voice quality and effort to speak better with the PVHP compared to their regular VP, which was not found by the blinded perceptual evaluations of the SLPs. This could be the effect of the ‘take-the-best heuristic’, where people assume “new is better”, and score new products initially better than they perform21. Looking at the results of the VHI-10, only two participants rated their voice as normal and not limiting during daily life, all the others rated their voice as a handicap. This finding is comparable with other publications2, 19. The AVQI is an objective acoustic outcome measure. The mean AVQI score was the same for the regular and new VP (8.5), which means that all participants had a distorted voice quality (score > 2.5). It is clearly visible that patients rate their voice quality better than the objective scoring, and there are no differences between the types of VP[22]. As none of the objective scorings are validated for TE speech, AVQI scores have to be interpreted carefully19, 23. When looking at the maximum phonation time and loudness, we saw that both were slightly better with the PVHP compared to the regular VP. Device lifetime varies enormously, both inter- and intra-patient and seems to be very multifactorial9. Although this study is not powered to assess a realistic device lifetime, the device lifetime of the PVHP in this pilot was relatively short (median 64 days). This is inferior to the device lifetime of the ActiValve (165 days)11, but comparable with the Provox2 (63 days), Provox Vega (66 days)3 and the Blom-Singer Classic (69 days)4. The
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