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临床试验/NCT05754671
NCT05754671已完成不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Reliability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

laryngectomized patients

Experimental

干预措施: voice recording (Other)

health professionals

Experimental

干预措施: perceptual assessment of the recorded voice sample (Other)

结局指标

主要结局

Reliability

时间窗: 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.

次要结局

  • Training(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

D'Alatri Lucia

Prof

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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