Klaske van Sluis

Voice outcomes following total laryngectomy 49 optimistic QoL outcomes [7, 13–15]. Studies reporting acoustic voice outcome after total laryngectomy often compare different groups of voice restoration methods, and most report only on sufficient or even excellent speakers, po- tentially leading to selection bias [2, 16–18]. Despite this, several studies have demonstrated that poorer speech related QoL is associated with lower health related QoL scores after total laryngectomy [19, 20]. Prospective multidimensional evaluation over all groups of substitute-voice- speakers after laryngectomy has not yet been described in the literature. This study aims to assess the change of acoustic, patient rated, and clinician rated voice outcomes from pre- up to twelve months post-surgery. These outcomes could potentially play a role for both patients and clinicians to assist them in counselling and decision-making regarding treatment and rehabilitation. 3.2 Methods 3.2.1 Study design A prospective multicenter design was conducted over five hospitals. Data was collected between April 2015 till May 2019 in the following institutes: The Netherlands Cancer Institute, The Netherlands, Amsterdam; Chris O’Brien Lifehouse, Sydney, Australia; Westmead Hospital, Sydney, Australia; Liverpool Hospital, Sydney, Australia; Royal Prince Alfred Hospital, Sydney, Australia. Ethical clearance was obtained for the Netherlands Cancer Institute (number IRBd18005 / N18VOQ) as well for the Australian sites (Protocol no X16-0287 & HREC/16/RPAH/367). Patients eligible for total laryngectomy were approached to participate. In- clusion criteria were: over 18 years of age, curative intent laryngectomy, physi- cally and cognitively able and willing to perform assessments. Informed consent was obtained from all participants. When participants during the course of the study were palliated or died, follow-up assessments were cancelled. Data were collected at four time-points for each participant: prior to total la- ryngectomy (T0), three months (T1), six months (T2), and twelve months (T3) post-surgery. Study assessments included perceptual evaluation, voice record- ings and patient reported outcome measures (PROMs). Data collection was performed by an experienced Speech Language Pathologist (SLP). Voice record- ings included reading aloud a text, phonation of the vowel /a/ at normal pitch, as well as low, high, soft and loud. Visual Analogue Scales (VAS) were used to perceptual rate voice quality, resulting in a score of 0 to 10, with 0 representing worst and 10 indicating the best voice quality. Perceptual scores were provided by the clinician as well as the participant, resulting in the variables Perc. Voice SLP and Perc. Voice Pt. The use of this VAS perceptual scales are derived from a dedicated perceptual rating scale for substitute voices [21]. PROMs consisted EQ-5D-5L and Voice Handicap Index 10 item version