Validation and Cross-cultural Adaptation of Croatian Self-Evaluation of Communication Experiences After Laryngectomy Questionnaire
Conditions: Larynx Neoplasm, Laryngectomy; Status, Communication, Quality of Life
Sponsor: Osijek University Hospital

 
 
 
 
 
Study protocol and statistical analysis plan 
 
Validation and Cross-cultural Adaptation of 
Croatian SECEL Questionnaire 
NCT05346237 
 
 
 
 
 
 
October 7, 2021. 
 
 

Background 
Total laryngectomy is surgical removal of the entire larynx and it is performed in cases of 
advanced larynx cancer, resulting in permanent disconnection of the upper and lower airways, 
loss of natural voice and difficulty swallowing in some cases. There are three methods of 
restoring voice after this kind of procedure: electrolaryngeal voice, oesophageal voice or 
tracheoesophageal voice with voice prosthesis. Verbal communication is very important in 
everyday life; therefore, it is clear that laryngectomized persons experience an increased 
feeling of insecurity, depression, psychological and social problems that ultimately reduce the 
quality of life. The few questionnaires  designed for measuring the quality of life of patients 
with head and neck cancers (e.g., Performance Status Scale for Head and Neck, the Head and 
Neck Survey, EORTC QLQ-C30 and EORTC QLQ-H&N35) are insufficient, because these 
questionnaires have resulted in a better understanding of the impact of treatment in head 
and neck oncology and lack sensitive and important questions about voice and 
communication dysfunction which is an important issue for laryngeal cancer patients. 
Self-Evaluation of Communication Experiences after Laryngectomy (SECEL) questionnaire has 
been developed, with the aim of evaluating rehabilitation needs and the psychosocial care for 
patients with laryngeal cancer. This short but comprehensive self-report instrument measures 
the perceived adjustment to communication experiences and is intended to aid in 
determining counselling needs in patients with laryngeal cancer who are treated with a 
laryngectomy. The first aim of this study is to evaluate the translation, psychometric properties 
and cultural adaptation of a Croatian version of the SECEL questionnaire. Secondary aim is to 
examine relationship between the Croatian version of the SECEL and the Short Form Health 
Survey (SF-36) and the Voice Handicap Index (VHI) questionnaires and to examine relationship 
between objective voice measures and Self-Evaluation of Communication Experiences after 
Laryngectomy (SECEL:HR). 
Design of a research 
The research will be designed as prospective observational research, and will include patients 
who have undergone total laryngectomy, who regularly attended follow-up visits in the ENT 
clinic and fulfilled the study criteria.  Informed consent will be signed. The validation process 
will be formed according to the guidelines of the World Health Organization for the translation 
and cross-cultural adaptation of the measuring instrument. 
Materials and Methods 
Patients who have undergone total laryngectomy and completed minimal their 12-month 
period without disease after surgery and post-operative treatments such as radiotherapy or 
chemotherapy will be included in this cross-sectional study. Patients who regularly followed 
up and have preserved their reading skills. Exclusion criteria will be define considering the 
absence of any factors which could interfere with data collection (e.g., acute respiratory 
infection of the upper or lower respiratory tract, presence of neurologic or pulmonary 
diseases, recurrence of cancer, deviation from the research protocol).  

At the first visit all patients included in the study will complete the Croatian version of the 
Voice Handicap Index (VHI), Short Form Health Survey (SF-36) and Self-Evaluation of 
Communication Experiences after Laryngectomy (SECEL:HR) questionnaire. 
SECEL questionnaire consists of two parts. The first part examines the relevant general data 
on the person filling out the questionnaire, while the second part consists of 35 items 
questionably or statement-designed to examine communication experiences. Patients 
estimates the incidence of these communication difficulties on the Likert scale (0-never, 1-
sometimes, 2-often, 3-always). 35 items are grouped according to 3 subscales named General 
(0-15 score range), Environment (0-42 score range) and Attitude (0-45 score range), and item 
number 35 is a separate question: "Do you talk the same amount now as before your 
laryngectomy?" and is rated with a "yes," "more," and "less" rating category. The overall 
numerical score varies from 0 to 102, and the higher score indicates greater difficulties and 
worse postoperative speech-communication adjustment. The Voice Handicap Index (VHI) 
questionnaire consist of 30 items organized in three subscales functional, physical and 
emotional and also scored with Likert scale with overall score from 0 to 120. Higher scores 
indicate a greater handicap. The Short Form Health Survey (SF-36) is a multi-purpose short-
form health survey that consist of 36 questions divided in eight scales and clustered into two 
groups: physical and mental health. Each item was standardized (range 0-100), with a higher 
score representing better QoL. The objective assessment will include the MPT (maximal 
phonation time) measured in seconds as common clinical measure of glottal efficiency, the 
DDK (diadochokinesis) of the articulation organs of the 3-syllable "pa-ta-ka" in 5 seconds 
(rated in syll/s), or how quickly subjects can produce a series of rapid sounds which is a 
measure of speech efficiency. MPT and DDK of articulation organs are simple tests that can be 
easily performed in everyday clinical practice. In view of different acoustic outcomes of the 
alaryngeal speech and due to the lack of specific information on the relationship between the 
subjective impression of the laryngectomised person and voice measure, it is necessary to 
perform aerodynamic tests and tests of the articulation organs in order to identify and exclude 
laryngectomised patients with respiratory and articulation disorders. 
All patients will fulfil the SECEL:HR questionnaire twice, two weeks after the initial test and 
that will be considered as a re-test of the SECEL reliability analysis. 
Statistical analysis 
Absolute and relative frequencies will be used to represent categorical data. The Shapiro–
Willk test will be used to assess the normal distribution of continuous variables. In the case of 
deviation from the normal distribution, continuous data will be described using the median 
and interquartile range. The variance of the category variables will be tested using the Fisher’s 
exact 
test. 
The 
differences 
between 
three 
groups 
of 
patients 
(oesophageal, 
tracheoesophageal speech and electrolarynx) will be tested using the Kruskal-Walli’s test (post 
hoc Conover test). The test–retest reliability will be evaluated with a Pearson's correlation test 
and 2-way mixed-effects model (consistency definition) intraclass correlation coefficients 
(ICCs). The correlation between continuous variables will be evaluated by Pearson’s 
correlation coefficient (r). Reliability measurements determined the internal consistency of 
the items, subscales and the total scores for the SECEL, SF-36 and VHI, by using the Cronbach 

Alpha coefficient. All P values will be two-sided. The level of significance will be set to Alpha = 
0.05. The analysis will be conduct using the MedCalc® Statistical Software version 20.100 
(MedCalc Software Ltd, Ostend, Belgium; https://www.medcalc.org; 2022) and the IBM SPSS 
Statistics 23 (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 23.0. 
Armonk, NY: IBM Corp.)