Perceptual Assessment of the Tracheoesophageal Voice

Not Applicable

Completed

• Conditions: Tracheo-Esophageal Fistula Following Tracheostomy
• Interventions: Other: perceptual assessment of the recorded voice sample; Other: voice recording

• Registration Number: NCT05754671
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-04
• Primary Completion: 2021-04-04
• Study Completion: 2021-09-01
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-06
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
health professionals	perceptual assessment of the recorded voice sample	-
laryngectomized patients	voice recording	-

Primary Outcome Measures

Name	Time	Method
Reliability	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Training	4 months	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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS; 🇮🇹 Roma, Italy