Perceptual Assessment of the Tracheoesophageal Voice

NCT05754671 | Completed DMC

• 1 other identifier: 3554
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheo-Esophageal Fistula Following Tracheostomy

Keywords

voice prosthesis; perceptual evaluation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Training

  4 months

Study Arms (2)

laryngectomized patients

EXPERIMENTAL

Other: voice recording

health professionals

EXPERIMENTAL

Other: perceptual assessment of the recorded voice sample

Interventions

perceptual assessment of the recorded voice sample OTHER

perceptual assessment of the recorded voice samples

health professionals

voice recording OTHER

voice recording

laryngectomized patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• native Italian speakers;
• ability to produce TE voice.

You may not qualify if:

• reading difficulties;
• presence or suspicion of disease recurrence;
• other communication problems not related to Total laryngectomy.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, 00168, Italy

Location

Study Officials

• Lucia D'Alatri, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 6, 2023
• Study Start: December 4, 2020
• Primary Completion: April 4, 2021
• Study Completion: September 1, 2021
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)