10.14639/0392-100X-N1184
Objective. Chronic suppurative otitis media (CSOM) may result in a serious impairment of the quality of life (QoL). The most relevant characteristics of CSOM are well represented in the “Chronic Otitis Media Outcome Test 15” questionnaire (COMOT-15). The aim of the study was to translate and adapt the COMOT-15 questionnaire into Italian. Methods. This is a prospective study conducted on 52 Caucasian Italian-speaking patients with CSOM and 52 controls. The linguistic adaptation of the COMOT-15 consisted of the translation of the English version into Italian and reliability assessment of the translation. Psychometric measurements included internal consistency and test–retest reliability. Results. Cronbach’s α was 0.95. The test-retest reliability showed a strong positive correlation for total score and all subscales. Age and gender had no influence on the scores. The correlation between the COMOT-15 and the pure tone average showed a significant association for the scale “Hearing Function”. Conclusions. The Italian COMOT-15 questionnaire provides good internal consistency and is suitable for QoL evaluation in Italian-speaking patients suffering from CSOM. In addition, it is able to evaluate the subjective symptoms perceived by patients.
text/xml
1827-675X
1184
en
Elena Cantone
https://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
ear discharge
Cross-cultural adaptation and Italian validation of chronic otitis media outcome test 15 (COMOT-15)
Text.Serial.Journal
https://www.actaitalica.it/
41
Otology
2021-07-07
2020-10-16
2021-07-08
2021-07-08
277-281
1
Elena Cantone
2021/07/07
10.14639/0392-100X-N1184
277
Department of Neuroscience, Reproductive and Odontostomatological Sciences - ENT section, University “Federico II”, Naples, Italy
1827-675X
ear discharge
281
Cross-cultural adaptation and Italian validation of chronic otitis media outcome test 15 (COMOT-15)
https://www.actaitalica.it/article/download/1184/627
41
ACTA OTORHINOLARYNGOLOGICA ITALICA 2021;41:277-281; doi: 10.14639/0392-100X-N1184




Otology


Cross-cultural adaptation and Italian validation
of chronic otitis media outcome test 15 (COMOT-15)
Adattamento culturale e validazione in italiano del questionario COMOT-15
nella valutazione degli outcomes del trattamento dell’otite media cronica
Michele Cavaliere1, Pasquale Capriglione1, Flavia Cavaliere2, Eugenio De Corso3, Elisabetta Zanoletti4, Gaetano Motta5,
Maurizio Iengo1, Elena Cantone1
1
  Department of Neuroscience, Reproductive and Odontostomatological Sciences - ENT section, University “Federico II”, Naples,
Italy; 2 Department of Humanities, Philology Section, University of Naples Federico II, Naples, Italy; 3 Policlinico Universitario A.
Gemelli IRCCS, UOC Otorinolaringoiatria. Università Cattolica del Sacro Cuore, Rome, Italy; 4 Department of Neuroscience DNS,
Otolaryngology Section, Padova University, Padova, Italy; 5 Otorhinolaryngology, Head and Neck Surgery Unit, Department of Mental
and Physical Health and Preventive Medicine, Università degli Studi della Campania Luigi Vanvitelli, Naples, Italy


SUMMARY
Objective. Chronic suppurative otitis media (CSOM) may result in a serious impairment of
the quality of life (QoL). The most relevant characteristics of CSOM are well represented
in the “Chronic Otitis Media Outcome Test 15” questionnaire (COMOT-15). The aim of the
study was to translate and adapt the COMOT-15 questionnaire into Italian.
Methods. This is a prospective study conducted on 52 Caucasian Italian-speaking patients
with CSOM and 52 controls. The linguistic adaptation of the COMOT-15 consisted of the
translation of the English version into Italian and reliability assessment of the translation.           Received: October 16, 2020
Psychometric measurements included internal consistency and test–retest reliability.                     Accepted: December 3, 2020
Results. Cronbach’s α was 0.95. The test-retest reliability showed a strong positive correla-
tion for total score and all subscales. Age and gender had no influence on the scores. The               Correspondence
correlation between the COMOT-15 and the pure tone average showed a significant associa-                 Eugenio De Corso
                                                                                                         Fondazione Policlinico Universitario “A. Gemel-
tion for the scale “Hearing Function”.
                                                                                                         li - IRCCS, Catholic University of the Sacred Heart
Conclusions. The Italian COMOT-15 questionnaire provides good internal consistency and                   largo A. Gemelli 8, 00168 Rome, Italy
is suitable for QoL evaluation in Italian-speaking patients suffering from CSOM. In addi-                Tel. +39 06 30154439; Fax +39 06 3051194
tion, it is able to evaluate the subjective symptoms perceived by patients.                              E-mail: eugenio.decorso@policlinicogemelli.it
KEY WORDS: QoL, chronic otitis, COMOT 15, hearing loss, ear discharge
                                                                                                         Funding
                                                                                                         None.
RIASSUNTO
Obiettivo. L’otite media cronica suppurativa (OMCS) può determinare una grave com-                       Conflict of interest
promissione della qualità della vita (QoL) dei pazienti. Gli aspetti clinici più rilevanti               The Authors declare no conflict of interest.
dell’OMCS sono rappresentati nel questionario “Chronic Otitis Media Outcome Test 15”
(COMOT-15). Scopo dello studio è tradurre e adattare alla lingua italiana il questionario                  How to cite this article: Cavaliere M, Caprigli-
COMOT-15.                                                                                                  one P, Cavaliere F, et al. Cross-cultural adapta-
Metodi. Abbiamo effettuato uno studio prospettico di validazione arruolando 52 pazienti                    tion and Italian validation of chronic otitis media
con diagnosi di OMCS e 52 controlli. Il processo di adattamento linguistico del questiona-                 outcome test 15 (COMOT-15). Acta Otorhi-
rio è consistito nella traduzione della versione originale inglese in italiano e nella misura              nolaryngol Ital 2021;41:277-281. https://doi.
dell’affidabilità della stessa. Le misure psicometriche che abbiamo preso in considerazione                org/10.14639/0392-100X-N1184
includevano coerenza interna e affidabilità test-retest.
Risultati. Il Cronbach α era pari a 0,95. Abbiamo riscontrato una forte correlazione posi-               © Società Italiana di Otorinolaringoiatria
                                                                                                         e Chirurgia Cervico-Facciale
tiva sia per il punteggio totale che per tutte le sottoscale. Età e sesso non hanno influenzato
i punteggi. L’analisi delle correlazioni tra COMOT-15 e soglia uditiva per la via aerea ha
                                                                                                                        OPEN ACCESS
mostrato un’associazione significativa per la sottoscala “Funzione uditiva”.
Conclusioni. Sulla base dei nostri risultati è stato possibile dimostrare che la versione italiana del   This is an open access article distributed in accordance with
                                                                                                         the CC-BY-NC-ND (Creative Commons Attribution-Non-
questionario COMOT-15 da noi proposta ha una buona coerenza interna ed è particolarmente                 Commercial-NoDerivatives 4.0 International) license. The
adatta per la valutazione della QoL nei pazienti di lingua italiana affetti da otite media cronica       article can be used by giving appropriate credit and mentio-
suppurativa. Inoltre, esso è in grado di valutare i sintomi soggettivi percepiti dai pazienti.           ning the license, but only for non-commercial purposes and
                                                                                                         only in the original version. For further information: https://
PAROLE CHIAVE: QoL, otite cronica, COMOT-15, ipoacusia, otorrea                                          creativecommons.org/licenses/by-nc-nd/4.0/deed.en




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M. Cavaliere et al.




Introduction                                                      and psychological impairments, are well represented in the
                                                                  COMOT-15 questionnaire 6. However, it is crucial to de-
Otitis media (OM) includes various subtypes of patholo-
                                                                  velop questionnaires in native languages and ensure they
gies characterised by middle ear mucosa inflammation              are appropriate to the culture of the country so that they
such as acute otitis media (AOM), otitis media with ef-           can be used on larger groups of the population. Thus, we
fusion (OME), chronic suppurative otitis media (CSOM),            developed an Italian COMOT-15 questionnaire, which sub-
mastoiditis and cholesteatoma. CSOM (with or without              jectively assesses disease-specific QoL.
cholesteatoma) affects approximately 2-4% of the general          The aim of this study was to linguistically and culturally
population and is defined as a chronic inflammation of the        adapt the COMOT-15 questionnaire into Italian and to obtain
middle ear and mastoid cavity with or without tympanic            measures of its internal consistency and test-retest reliability.
membrane perforation 1-3. It is characterised by recurrent
ear discharge and hearing loss, and, less frequently, otalgia,
fever, vertigo and tinnitus 1.                                    Materials and methods
CSOM may be associated with significant limitation of hear-
ing function that may result in communication problems im-        Study population and study design
pairing social interaction and professional life. Conductive      This is a prospective instrument validation study that was
hearing loss is considered a serious disability, contributing     conducted on 52 Caucasian Italian-speaking patients affected
to a significant disease burden worldwide 4,5. In addition,       by CSOM who were diagnosed and followed at our institu-
persistent discharge from the ear, pain or frequent physician     tion. Patients were enrolled between January 2018-Decem-
visits may result in a serious impairment of patients’ quality    ber 2018 at ENT section of Department of Neuroscience,
of life (QoL) 4,5. In case of CSOM with cholesteatoma, com-       Reproductive and Odontostomatological Sciences, Univer-
plications such as facial nerve paralysis, Bezold’s, Luc’s, Ci-   sity “Federico II” of Naples, Italy. We enrolled as controls 52
telli’s abscesses, meningitis or encephalitis, may develop and    Caucasian Italian-speaking healthy volunteers. A diagnosis of
potentially threaten the patient’s life 6.                        CSOM was obtained from the patient’s medical history, ENT
QoL measures are clinically important to determine the            examinations, including otomicroscopy and oto-endoscopy,
impact of the disease, as well as the effectiveness of dif-       pure tone audiometry and computed tomography (CT) scans.
ferent types of treatment, and assessment of objective            All subjects were asked to fill in the translated COMOT-15
parameters does not mirror the subjective experiences of          questionnaire on their own during their first visit to the out-
patients. Health-related QoL is particularly important in         patient clinic and again one month after their first visit for
chronic health conditions, such as CSOM, requiring long-          retest evaluation.
term treatment and life-long care. Generally, hearing levels      The linguistic adaptation process of the Italian version of
measured by pure tone audiometry have been used to define         the COMOT-15 questionnaire consisted of two phases: the
and quantify CSOM-related QoL. However, disabling hear-           first phase was translation of the original English version
ing loss on audiometric data may not correlate with QoL 7.        into Italian, and the second consisted of measuring the reli-
Assessing subjectively QoL with a specific questionnaire is       ability of the translation obtained.
steadily increasing in clinical medicine and, in particular,      Pure-tone audiometry for testing conventional frequency
in different otorhinolaryngological diseases as rhinosinusi-      range (0.125 to 8 kHz), was performed using an Amplaid 319
tis, several studies have reported that physicians’ ratings of    audiometer (Amplaid Inc., Milan, Italy) in a double-walled,
the QoL in patients with chronic illness were significantly       soundproof room. Pure-tone average values were calculated
different from patients’ self-rated QoL 5-7. Currently, in        in dB from the air conduction hearing loss as the mean of
clinical practice, there are a large number of questionnaires     0.5, 1, 2 and 4 kHz thresholds (pure tone average, PTA).
that can measure QoL 5-7. However, not all questionnaires         Subjects signed an informed consent form before partici-
are able to evaluate the subjective symptoms, functional          pating in the study. All procedures performed in studies
outcomes and the psychological aspects of CSOM 4-6.               were in accordance with the ethical standards of the insti-
Generic questionnaires, as the Short Form 36 Health Sur-          tutional research committee and with the 1964 Helsinki
vey (SF-36), can be used to assess CSOM-related discom-           declaration and its later amendments or comparable ethical
fort, but they are not disease-specific and can, therefore,       standards. Local Board of Medical Ethics number 339/20.
underestimate the impact of the disease on patients’ QoL.
Hence, disease-specific measures are more sensitive than          COMOT-15 questionnaire
generic measures 5. So far, the most relevant characteris-        The COMOT-15 consists of 3 subscales, categorised as ear
tics of CSOM, including clinical symptoms and functional          symptoms (questions 1-6), hearing function (questions 7-9)



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and mental health (questions 10-13), which form the overall
score. In addition to questions from 1 to 13, the COMOT-15
contains two other questions: a general evaluation of the im-
pact of CSOM on QoL (question 14) and a question on the
frequency of ENT visits as a result of CSOM in the previous
6 months (question 15). The total score and the 3 subscales
were transformed into a 0-100 score by dividing the sum of
the raw scores of the items by the sum of spans of the items,
followed by multiplying this number by 100 4.

Linguistic adaptation process of the Italian version
of the COMOT-15
The linguistic adaptation was obtained by translation of the
original version in English into Italian and back-translation
into English again. Two native Italian otolaryngologists and
one bilingual expert whose mother tongue was Italian inde-
pendently translated the questionnaire. The 3 versions were
unified by consensus between the translator and researchers.
The bilingual translator back-translated this final version.
After the back-translation, the two otolaryngologists and the
bilingual expert adapted the Italian questionnaire in order to
improve the semantic equivalence of meaning between the
two English versions. After these steps had been completed,
the first version of the Italian COMOT-15 questionnaire was
conceived. This version was initially pilot-tested on a sample
                                                                   Figure 1. The Italian version of COMOT-15 questionnaire.
of 25 healthy volunteers to determine whether the questions
could be clearly understood. The pilot test was performed by       The absolute scores of the healthy participants and pa-
a single investigator (EC) through a direct interview to assess    tients were analysed with the non-parametric Mann-
possible difficulties in understanding the questionnaire. Af-      Whitney U-test to assess the validity of the question-
ter some words were modified to facilitate comprehension,          naire. Statistical significance was achieved for a p
the Italian translation was finalised (Fig. 1).                    inferior to 0.05.

Measuring the reliability of the cross adapted
Italian version of COMOT-15                                        Results
In a second phase of this study, we compared patients diag-        We recruited 52 Caucasian Italian-speaking patients (mean
nosed with CSOM with healthy volunteers. Exclusion cri-            age was 48.3 ± 16.1 SD, range 18-64 years; 28 females)
teria were as follows: age < 18, lack of full legal capacity,      diagnosed with CSOM and 52 Caucasian Italian-speaking
inability to read and understand Italian, immunodeficiency,        healthy volunteers (mean age 42.6 ± 10.1 SD, range 19-62;
diabetes, heart, oncological, immunological, malforma-             29 females). The male/female ratio was 0.8 in the investi-
tions, neuropsychiatric diseases and previous ear surgery.         gational arm and 0.7 in the control arm.
                                                                   We found a bilateral CSOM in 13/52 subjects (25% of cas-
Data analysis                                                      es) and 38/52 (73%) CSOM with cholesteatoma. Pure tone
The data were analysed with SPSS 19 for Windows (IBM               average (PTA) [dB] calculated from air conduction hear-
Corp., Armonk, NY). Continuous baseline characteristics            ing loss at 0.5, 1, 2 and 4 kHz in CSOM patients showed
were presented as the mean and standard deviation. The             a value of 55[dB] ± 10.2 SD. The opposite ear showed a
internal consistency of the test was determined using Cron-        healthy aspect in 39/52 (75 %) patients.
bach’s α. The test-retest reliability was assessed by explor-      The total score of the Italian version of COMOT-15 was
ing the correlation between the COMOT-15 scores obtained           36.76 ± 13.1 (mean ± SD). The mean scores of the sub-
during the first visit at the outpatient clinic (test) and those   scales of COMOT-15 were 11.05 ± 4.45 (mean ± SD)
obtained one month after the first visit (retest) by using the     for ear symptoms, 13.48 ± 5.83 (mean ± SD) for hearing
Pearson correlation coefficient.                                   function and 9.69 ± 4.65 (mean ± SD) for mental health



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M. Cavaliere et al.




Figure 2. Mean scores of the Italian version of COMOT-15. The mean total score   Figure 3. Test-retest reliability. The test-retest reliability showed a strong,
of the Italian version of COMOT-15 was 36.76 ± 3.1. The mean scores of the       positive Pearson correlation coefficient (r = 0.98, p = 0.00001) for total score
subscales of COMOT-15 were 11.05 ± 4.45 for ear symptoms, 13.48 ± 5.83           and all subscales: ear symptoms p < 0.01, hearing function p < 0.01, mental
for hearing function, and 9.69 ± 4.65 for mental health (mean ± SD).             health p < 0.01.


(Fig. 2). The mean scores of subgroups, CSOM with/with-                          the Italian COMOT-15 (36.76 ± 13.1, mean ± SD) suggest-
out cholesteatoma, are reported in Table I.                                      ed a deterioration of QoL in patients affected by CSOM.
The Mann-Whitney U-test showed that the COMOT-15                                 In addition, the mean scores of the subscales pointed out
scores were significantly higher in patients with CSOM                           that ear symptoms were the major cause of reduced QoL in
than in control subjects (U = 68.5, p = 0.0001).                                 Italian-speaking individuals with CSOM.
The internal consistency was supported by a Cronbach’s α                         QoL measurements in CSOM subjects assess the impact
of 0.95. The test-retest reliability showed a strong, positive                   of the disease on patient’s overall health, social interac-
Pearson correlation coefficient (r = 0.98, p = 0.00001) for                      tion and psychological status 6. The most common CSOM
total score and all subscales: ear symptoms p < 0.01, hear-                      QoL questionnaires, although each with some limitations,
ing function p < 0.01 mental health p < 0.01 (Fig. 3). Age                       are: the Glasgow Benefit Inventory (GBI), Glasgow Health
and gender had no influence on the evaluation of the scores                      Status Inventory (GHSI), Chronic Ear Survey (CES) 8,
of COMOT-15 (p > 0.05).                                                          Chronic Otitis Media Questionnaire 12 (COMQ-12), Otitis
The analysis of correlations between the scales of the CO-                       Media-6 questionnaire (OM-6) and the health-related QoL
MOT-15 and the pure tone average showed a significant                            (HRQoL) 5,6,9-11. The GBI was designed to evaluate changes
association for the scale “Hearing Function”, p < 0.008.                         in QoL following surgery, whereas the GHSI measures the
                                                                                 impact of a health problem on the QoL and provides in-
                                                                                 formation about the physical health subscale. Although the
Discussion                                                                       GBI and GHSI have been commonly used for ear, nose and
The present study aimed to translate the COMOT-15 into                           throat diseases, they do not give enough information about
the Italian language. The translated version was adminis-                        the hearing function and mental health of the patient 5.
tered to a large study population.                                               The CES questionnaire includes some single items evaluat-
The results showed that the Italian COMOT-15 provides                            ing the frequency of symptoms or medical problems, but it
good reliability as well as internal consistency, suggesting                     does not include a subjective assessment of their severity as
its suitability in determining the QoL of Italian-speaking                       perceived by the patients 4,7,8. It does not seem to adequately
individuals suffering from CSOM. The mean total score of                         cover the subjective point of view of the patients 4,8.

Table I. Mean scores of the Italian version of COMOT-15 in subgroups (CSOM with cholesteatoma and without cholesteatoma). Differences between total cases
scores and subgroups (CSOM with/without cholesteatoma) scores are not statistically significant (mean ± SD).
                                               No.       Overall score              Ear symptoms             Hearing function        Mental health
 Total cases                                   52           36.76 ± 13.1            11.05 ± 4.45                13.48 ± 5.83               9.69 ± 4.65
 CSOM with cholesteatoma                       38          37.02 ± 13.43            11.41 ± 4.19                13.92 ± 5.49               10.01 ± 4.38
 CSOM without cholesteatoma                    14          36.07 ± 12.76            10.08 ± 4.64                12.29 ± 6.07               8.84 ± 4.84




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