Perceptual Assessment of the Tracheoesophageal Voice

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

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.

Study Overview

• Status: Completed
• Conditions: Tracheo-Esophageal Fistula Following Tracheostomy
• Intervention / Treatment: Other: voice recording; Other: perceptual assessment of the recorded voice sample

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli - IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laryngectomized patients	Other: voice recording; voice recording
Experimental: health professionals	Other: perceptual assessment of the recorded voice sample; perceptual assessment of the recorded voice samples

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Lucia D'Alatri, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): April 4, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: voice prosthesis; perceptual evaluation
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Digestive System Fistula; Tracheal Diseases; Respiratory Tract Fistula; Fistula; Tracheoesophageal Fistula; Esophageal Fistula
• Other Study ID Numbers: 3554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No