Perceptual Assessment of the Tracheoesophageal Voice

Study Overview
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Brief Summary
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Aim of this study was to validate the Sunderland Tracheoesophageal Perceptual Scale (SToPS) in Italian language by checking the inter- and intra-rater reliability. The validation of the tool involved the following steps: 1) Translation and adaptation of the SToPS into Italian language; 2) Recruitment of participants (43 laryngectomized patients with a voice prosthesis and 12 health professionals - 6 speech and language therapists (SLTs) and 6 Ear, Nose, and Throat (ENTs) surgeons - classified into experienced or not at assessing voice; 3) Recording of patients' speech samples; 4) Perceptual evaluation of recorded speech samples (test and re-test) performed by the 12 health professionals; 5) Statistical analysis (quadratic weighted Cohen Kappa and weighted Kappa of Light coefficients). SLTs with specific experience in tracheo-esophageal and laryngeal voice rated more reliably than the others raters. For all groups of raters, the inter-rater agreement was worse than the intra-rater one for 9/10 parameters. Exclusively for experienced SLTs, only the Impairment of social acceptability parameter reached a good level of inter-rater agreement. In conclusion, the Italian version of SToPS can be considered a reliable tool. As in the original version, expert SLTs may be considered the optimal judges for tracheoesophageal voice assessment.

Official Title
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PERCEPTUAL EVALUATION OF THE TRACHEO-OESOPHAGEAL VOICE: ITALIAN VALIDATION OF THE SUNDERLAND TRACHEOESOPHAGEAL PERCEPTUAL SCALE (I-SToPS)

Conditions
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Tracheo-Esophageal Fistula Following Tracheostomy

Intervention / Treatment
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* Other: perceptual assessment of the recorded voice sample
* Other: voice recording


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: native Italian speakers; ability to produce TE voice. Exclusion Criteria: reading difficulties; presence or suspicion of disease recurrence; other communication problems not related to Total laryngectomy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laryngectomized patients<br> | Other: voice recording<br>* voice recording<br>|
| Experimental: health professionals<br> | Other: perceptual assessment of the recorded voice sample<br>* perceptual assessment of the recorded voice samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability | The primary aim of this study was to carry out a psychometric validation in Italian of a perceptual evaluation scale for use by clinicians. The intra- and inter-rater reliability of each parameter was analyzed with Cohen's kappa weighted quadratic statistic. A weighted average kappa coefficient equal to or greater than 0.61 has been considered a good level of agreement. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training | Secondary aim was to investigate whether the SToPS could be used without training, using written guidelines only and focusing on the effect of experience on the administration of the SToPS. For this reason, the reliability results obtained were compared with those of the original study. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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voice prosthesis, perceptual evaluation