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Slovenian Cross-Cultural Adaptation and Validation of Health-Related Quality of Life Measures for Chronic Otitis Media (COMQ-12), Vertigo (DHI, NVI) and TINNITUS (THI)

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Slovenian Cross-Cultural Adaptation and Validation of Health-Related Quality of Life Measures for Chronic Otitis Media (COMQ-12), Vertigo (DHI, NVI) and TINNITUS (THI)

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Purpose: To provide physicians and patients with the tools needed to evaluate patients’ problems and health-related quality of life by cross-culturally adapting and validating the Chronic Otitis Media Questionnaire 12 (COMQ-12), the Dizziness Handicap Inventory (DHI), the Neuropsychological Vertigo Inventory (NVI) and the Tinnitus Handicap Inventory (THI). Materials and methods: COMQ-12, DHI, NVI and THI were translated into the Slovenian language and completed by patients treated at our department for chronic otitis media, vertigo or tinnitus. The control group for each questionnaire consisted of healthy volunteers. Internal consistency, test-retest reliability, discriminant validity, diagnostic accuracy and cut-off value were determined for each questionnaire. Results: Test-retest reliability was excellent for DHI (ICC A=0.946) and NVI (p=0.315, ICC A=0.975), good to excellent for COMQ-12 (p=0.680, ICC A=0.858) and satisfactory for THI (p=0.120). Discriminant validity was confirmed for each questionnaire (p>0.05) using the Mann-Whitney U test (COMQ-12, DHI, THI) or the Welch t-test (NVI). COMQ-12 had acceptable (α=0.796) and DHI (α=0.910), NVI (α=0.950) and THI (α=0.924) perfect internal consistency. COMQ-12 and DHI had excellent, NVI acceptable and THI perfect diagnostic accuracy (AUC=0.987, AUC=0.999, AUC=0.781 and AUC=1.000 respectively). Cut-off values determined by Youden’s index were 7, 7, 9 and 56 for COMQ-12, THI, DHI and NVI, respectively. Conclusion: Slovenian COMQ-12, DHI, NVI and THI are a valid and accurate tool for the diagnosis and measurement of health-related quality of life in patients with chronic otitis media, vertigo and tinnitus. They could aid general practitioners, occupational health specialists, neurologists and otorhinolaryngologists.
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SLOVENIAN CROSS-CULTURAL ADAPTATION AND VALIDATION OF
HEALTH-RELATED QUALITY OF LIFE MEASURES FOR CHRONIC
OTITIS MEDIA (COMQ-12), VERTIGO (DHI, NVI) AND TINNITUS (THI)
Domen VOZEL1,2, Nejc STEINER1, Nina BOŽANIĆ URBANČIČ1,2, Dejan MLADENOV3, Saba BATTELINO1,2*
1University Medical Centre Ljubljana, Department of Otorhinolaryngology
and Cervicofacial Surgery, Zaloška 2, 1000 Ljubljana, Slovenia
2University of Ljubljana, Faculty of Medicine, Department of Otorhinolaringology,
Vrazov trg 2, 1000 Ljubljana, Slovenia
3Železniški zdravstveni dom Ljubljana, Celovška cesta 4, 1000 Ljubljana, Slovenia
Received: Jan 20, 2020
Accepted: Apr 2, 2020
Original scientic article
*Corresponding author: Tel. + 386 1 522 83 07; E-mail: saba.battelino@kclj.si
10.2478/sjph-2020-0016 Zdr Varst. 2020;59(3):120-127
MEDKULTURNA PRILAGODITEV IN POTRDITEV SLOVENSKIH RAZLIČIC
VPRAŠALNIKOV ZA OCENO KRONIČNEGA VNETJA SREDNJEGA
UŠESA (COMQ-12), VRTOGLAVICE (DHI, NVI) IN TINITUSA (THI)
Vozel D, Steiner N, Božanić Urbančič N, Mladenov D, Battelino S. Slovenian cross-cultural adaptation and validation of health-related quality of life measures for
chronic otitis media (COMQ-12), vertigo (DHI, NVI) and tinnitus (THI). Zdr Varst. 2020;59(3):120-127. doi: 10.2478/sjph-2020-00016.
ABSTR ACT
Keywords:
quality of life,
surveys and
questionnaires,
tinnitus, vertigo,
otitis media,
dizziness
IZVLEČEK
Ključne besede:
kakovost življenja,
ankete in vprašalnik,
tinitus, vrtoglavica,
vnetje srednjega
ušesa, nestabilnost
Purpose: To provide physicians and patients with the tools needed to evaluate patients’ problems and health-related
quality of life by cross-culturally adapting and validating the Chronic Otitis Media Questionnaire 12 (COMQ-12), the
Dizziness Handicap Inventory (DHI), the Neuropsychological Vertigo Inventory (NVI) and the Tinnitus Handicap Inventory
(THI).
Materials and methods: COMQ-12, DHI, NVI and THI were translated into the Slovenian language and completed by
patients treated at our department for chronic otitis media, vertigo or tinnitus. The control group for each questionnaire
consisted of healthy volunteers. Internal consistency, test-retest reliability, discriminant validity, diagnostic accuracy
and cut-off value were determined for each questionnaire.
Results: Test-retest reliability was excellent for DHI (ICC A=0.946) and NVI (p=0.315, ICC A=0.975), good to excellent
for COMQ-12 (p=0.680, ICC A=0.858) and satisfactory for THI (p=0.120). Discriminant validity was conrmed for each
questionnaire (p>0.05) using the Mann-Whitney U test (COMQ-12, DHI, THI) or the Welch t-test (NVI). COMQ-12 had
acceptable (α=0.796) and DHI (α=0.910), NVI (α=0.950) and THI (α=0.924) perfect internal consistency. COMQ-12 and DHI
had excellent, NVI acceptable and THI perfect diagnostic accuracy (AUC=0.987, AUC=0.999, AUC=0.781 and AUC=1.000
respectively). Cut-off values determined by Youden’s index were 7, 7, 9 and 56 for COMQ-12, THI, DHI and NVI, respectively.
Conclusion: Slovenian COMQ-12, DHI, NVI and THI are a valid and accurate tool for the diagnosis and measurement
of health-related quality of life in patients with chronic otitis media, vertigo and tinnitus. They could aid general
practitioners, occupational health specialists, neurologists and otorhinolaryngologists.
Namen: Orodja za oceno težav bolnikov s kroničnimi vnetji srednjega ušesa, težav z ravnotežjem in tinitusom ter vpliv
slednjih na kakovost življenja v slovenščini ne obstajajo. S projektom smo jih želeli zagotoviti zdravnikom in bolnikom s
temi težavami. Vrzel bi zapolnili z medkulturno prilagoditvijo in potrditvijo vprašalnika o kroničnem vnetju srednjega
ušesa (COMQ-12), vrtoglavici (DHI), nevropsiholoških vplivih vrtoglavice (NVI) in o obremenjenosti zaradi tinitusa (THI).
Metode: Vprašalniki so bili prevedeni iz angleščine v slovenščino skladno s priporočili. COMQ-12 so izpolnili bolniki s
kroničnim vnetjem srednjega ušesa, DHI in NVI z vrtoglavico in THI s tinitusom. Kontrolno skupino za vsak vprašalnik
so sestavljali zdravi prostovoljci. Vsakemu vprašalniku je bila določena stopnja notranje skladnosti, zanesljivost pri
ponovnem testiranju, diskriminantna validnost, diagnostična natančnost in mejna vrednost.
Rezultati: Zanesljivost pri ponovnem testiranju je bila odlna za DHI (ICCA = 0,946) in NVI (p = 0,315, ICCA = 0,975),
dobra do odlična za COMQ-12 (p = 0,680, ICCA = 0,858) in zadovoljiva za THI (p = 0,120). Diskriminantna validnost je bila
potrjena (p > 0,05) za vsak vprašalnik bodisi z uporabo testa Mann-Whitney U (COMQ-12, DHI, THI) bodisi z Welchovim
t-testom (NVI). COMQ-12 je imel sprejemljivo = 796), DHI = 0,910), NVI = 0,950) in THI (α = 0,924) pa popolno
notranjo skladnost. COMQ-12 in DHI sta imela odlično (0,987 in 0,999), NVI sprejemljivo (0,781) in THI popolno (1,000)
diagnostično natančnost glede na vrednost površine pod krivuljo ROC. Mejne vrednosti so bile določene objektivno z
Youd onovi m ind eksom (J) in so zn ale 7 za COMQ -12 (J = 0,90) in THI (J = 1,00), 9 za DHI (J = 0,95) in 56 za NVI (J = 0,43).
Zaključek: Slovenske različice vprašalnikov COMQ-12, DHI, NVI in THI so medkulturno prilagojene, potrjene in uporabne
ko t pome m b na me r il a za oc eno z zd ra v jem po vez a ne ka k ov o sti življe nja . Hkra ti so tudi na ta n č en di agno s t n i pri p om e k
pri bolnikih s kroničnim vnetjem srednjega ušesa, vrtoglavico ali tinitusom, ki bo v pomoč zdravnikom specialistom
družinske medicine, specialistom medicine dela, prometa in športa, nevrologom ter otorinolaringologom.
120
© National Institute of Public Health, Slovenia.
1 INTRODUCTION
Patient-reported health-related quality-of-life (HRQoL)
questionnaires are an indispensable tool for general
practitioners, occupational health specialists and
physicians of other medical specialisations when
approaching a variety of medical conditions. They
provide subjective information about the patient’s health
status, and complement the objective ndings of clinical
examination or diagnostic procedures (1-3). They also play
an important role in assessing treatment efcacy in many
otorhinolaryngologic diseases (4).
Chronic otitis media (COM), dizziness and tinnitus are
common diseases and symptoms that can have a great
impact on HRQoL. Different questionnaires are therefore
available in various languages to assess it. Moreover,
as there is a common overlap of COM, dizziness and
tinnitus-associated complaints in a single patient, it is
appropriate to provide multiple questionnaires to assess
these complaints. COMQ-12, DHI, NVI and THI are useful
questionnaires to determine physical, cognitive, socio-
economic and emotional neuropsychological inuences of
the disease on HRQoL (5-8).
When modifying a questionnaire from an original to the
desired target language, a thorough process of cross-
cultural adaptation and validation is required, rather
than a simple translation (9). It appears that this process
may present a certain obstacle as, to the best of our
knowledge, no such questionnaires for patients with COM,
dizziness and tinnitus have yet been produced in the
Slovenian language.
There is therefore a desire to provide such questionnaires
to physicians dealing with patients with COM, dizziness and
tinnitus in Slovenia. For that reason, the purpose of our
study was to cross-culturally adapt and validate Chronic
Otitis Media Questionnaire 12 (COMQ-12), the Dizziness
Handicap Inventory (DHI), the Neuropsychological Vertigo
Inventory (NVI) and the Tinnitus Handicap Inventory (THI)
into the Slovenian language for the rst time. Furthermore,
Slovenian versions of COMQ-12, DHI, NVI and THI would
contribute to a further comparison of populations divided
by culture or language.
1.1 Chronic Otitis Media
COM can be dened as at least three months of persistent
middle ear inammation with an associated permanent
tympanic membrane defect. While inconsistent denitions
of COM make the analysis of epidemiological data difcult,
assessments of the burden presented by otitis media have
been made. It is a leading reason why patients visit a
doctor and are prescribed medication, and it places the
brunt of the burden on developing countries (10). In some
countries, the cost of treating ear infections is higher
than the minimum monthly wage (11). The population of
developed industrialised countries, including Slovenia,
is the least at risk (10). COM causes disabling hearing
loss, impedes speech development and involvement in
education, and makes it more difcult to nd and retain
employment in jobs that require high levels of qualication
(12). Additionally, patients with COM are affected by ear
discharge, ear discomfort, balance disorders, tinnitus and
mental disorders, all of which lead to poorer quality of life
and higher levels of absenteeism (13, 14). HRQoL patient-
reported questionnaires are therefore an important
adjunct to the management of patients with COM (5).
1.2 COM Q -12
At least ve patient-reported HRQoL questionnaires are
available to assess the quality of life of COM patients.
COMQ-12, and ZCMEI-21 are upgrades of CES, COMOT-15,
COM-5. COMQ-12 is shorter than ZCMEI-21 (14, 15). Chronic
Otitis Media Questionnaire 12 (COMQ-12) contains 12
questions: seven related to the severity of symptoms,
two to the impact of the disease on lifestyle, two to the
impact on healthcare and one general question. Each
answer is given a score of 0-5 points (14). A total score is
also determined for persons without COM. Additionally,
if the total score is ≤5, surgical treatment should be
reconsidered (16). The original English version has so far
been translated into Turkish (5), Portuguese (17), Indian
(18), Serbian (19) and Dutch (20, 21), etc.
1.3 Vertigo
Vertigo is dened as the perception of rotation or
movement of an individual or objects in space. Patients
often confuse it with symptoms of dizziness or visual
or balance disturbance (7). In addition to the normal
functioning of the vestibular apparatus, normal balance
requires good vision and proprioception and good
functioning of the central nervous system, which is
where the integration of signals from these systems
takes place. Damage to any of these structures can cause
vertigo. Dizziness, impaired balance, vision, emotions,
memory and self-perception may be associated with
vertigo depending on the location of the dysfunction of
the vestibular system. Understandably, patients often
experience vertigo, dizziness and unsteadiness at the
same time (rarely each of these symptoms individually).
About 50% of people experience vertigo, 40% unsteadiness
and 35% dizziness in one year (22). Vertigo and dizziness
are also risk factors for falls, especially in the elderly (23).
These problems lead to loss of an employment in 20% and
reduction of work efciency and social life impairment
in 50% of cases (24). Vertigo and dizziness can therefore
severely reduce quality of life and represent a major public
health problem. For that reason, it is crucial to evaluate
a patient’s problems by means of patient-reported HRQoL
questionnaires.
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10.2478/sjph-2020-0016 Zdr Varst. 2020;59(3):120-127
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1.4 DHI
The DHI is a reference questionnaire (25) most commonly
used to evaluate vertigo-associated problems (7). It has
been developed to evaluate problems with balance,
since the results of vestibulometry (e.g. caloric test)
are often inconsistent with the clinical ndings (26, 27).
The DHI consists of 25 questions, 7 of which are related
to physical, 9 to emotional and 9 to the functional
inuences of vertigo. The patient answers each question
with “yes” (4 points), “sometimes” (2 points) or “no” (0
points). A higher total score means that vertigo has a
more severe impact on the patient’s quality of life. Four
questions directly evaluate issues specic to the problems
associated with benign paroxysmal positional vertigo (27).
DHI has been translated into Swedish (28), Chinese (29),
Dutch (30), Turkish (31), Italian (32), German (33), Spanish
(34), Greek (6), etc.
1.5 NVI
The NVI was developed in response to the absence of
questionnaires that evaluate vertigo-related cognitive
problems. It tests attention, memory, emotion, vision,
motor skills, and spatial and time perception. It is
therefore designed to assess patient-reported, vertigo-
associated neuropsychological problems. The NVI has
so far been made available in English and French (35).
The French version consists of 28 and the English of 32
questions, containing 4 distractors (7, 35). The answer
to each question is scored using the Likert scale (7). The
English version without distractors was used to cross-
culturally adapt and validate the Slovenian NVI.
1.6 Tinnitus
Tinnitus is the perception of sound without a known
external stimulus (36). In 8-17% of people, it occurs as
temporary simple ringing after exposure to noise and it
is rarely permanent (37). Its incidence increases with age
and is present in 15% of people over the age of 65 (36,
37). In most cases, people do not seek medical attention
because of tinnitus, as it does not signicantly impact
their daily life. However, it does have a signicant impact
on quality of life in some (36), and leads to hyperacusis,
impaired cognitive ability, anhedonia, anxiety, depression
and insomnia. Suicidality resulting from severe tinnitus has
also been reported (37). Tinnitus can therefore interfere
with daily activities (38) and affects the quality of life
of certain personality types more signicantly (38). The
degree of tinnitus impairment also depends on tinnitus
awareness throughout the day, the loudness and variability
of the tinnitus, education, and additional physical
symptoms (39). Although tinnitus can be determined
audiometrically, patient-reported HRQoL questionnaires
present an indispensable tool for evaluating tinnitus (40,
41).
1.7 THI
The THI is useful for evaluating tinnitus and its impact
on HRQoL. It comprises 25 questions and is expected to
complement the DHI in clinical practice. Twelve questions
evaluate functional, eight emotional and ve catastrophic
responses to tinnitus. The patient answers each question
with “yes” (4 points), “sometimes” (2 points) or “no” (0
points), where the maximum score is 100. Scoring 78–100
points means that the tinnitus is catastrophic, 58–76
severe, 38-56 moderate, 18-36 mild and <18 light (42). The
THI has been translated into Hungarian (43), Danish (44),
Polish (45), Korean (46), Brazilian Portuguese (47), Turkish
(48), Italian (49), Chinese (50, 51), French (52, 53), Hebrew
(54), Russian (8), etc.
2 MATERIALS AND METHODS
2.1 Translation and Cross-Cultural Adaptation of
Questionnaires
To enable replicability, the cross-cultural adaptation
and validation processes are described according to the
guidelines for translating and adapting hearing-related
questionnaires for different languages and cultures by Hall
et al. (9).
We conducted an initial review of the literature and
were unable to locate any Slovenian versions of the
COMQ-12, DHI, NVI or THI questionnaires. Permission to
use the questionnaires was obtained from the authors
of the original questionnaires. These authors were
available for any additional questions regarding concepts
or ambiguities behind the items. Literacy, population
characteristics and the requirement for administrative
help were evaluated for the target population. Template
documents for recording the translation and adaptation
process were created and the denition of concepts for
each questionnaire item developed.
Two independent dual-language translators (native
Slovenian speakers with a very good knowledge of English)
were briefed on the questionnaires and their clinical
concepts. They independently translated questionnaires
into Slovenian (i.e. forward translation). The two
translations were harmonised by two eld experts to
create a single translation.
Two independent dual-language translators (native English
speakers with a very good knowledge of Slovenian) then
independently translated the questionnaires back to
the English language (i.e. back-translation). The two
translations were reconciled by two eld experts to create
a single translation, which was then reviewed by the board
of experts (one otosurgeon, one audiologist, two general
otorhinolaryngology consultants, two otorhinolaryngology
residents, one non-medical translation consultant).
This was followed by pilot testing with the target audience
(20 patients for each questionnaire) to ensure that the
questions were understood and culturally appropriate.
The results of the pilot testing were reviewed and the
translation nalised. The same board of experts formatted
and proofread the nalised translation. The questionnaires
were then given to patients with COM, dizziness or
tinnitus and to healthy volunteers. These subjects were
later included in the statistical analysis.
2.2 Subjects
Patients treated at our department for COM, vertigo or
tinnitus completed the COMQ-12, DHI, NVI or THI after
an otorhinolaryngological check-up and conrmation of
the diagnosis. The control groups for each questionnaire
consisted of healthy volunteers, i.e. medical staff and
their acquaintances or relatives. Every subject gave
informed consent.
2.3 Statistical Analysis
After the cross-cultural adaptation of all the questionnaires,
the validation was performed using various statistical
methods; these are thoroughly described in order to
enable replicability. Data were analysed using Microsoft
Excel for Mac (version 16 and later) and SPSS (Statistical
Package for the Social Sciences, version 23, IBM Corp.,
Armonk, NY, USA).
Internal consistency, test-retest reliability, discriminant
validity, diagnostic accuracy and cut-off value were
determined for each questionnaire. Internal consistency
was determined with Cronbach’s alpha and diagnostic
accuracy and cut-off values using ROC curve analysis
and Youden’s index (55). Test-retest reliabilities and
discriminant validities were determined by means of
various statistical tests and depending on the analysed
data.
3 R ESULTS
The Slovenian translations of the COMQ-12, DHI, NVI and
THI are available from the authors upon request and from
the institution’s ofcial website.
3.1 COM Q -12
COMQ-12 was completed by 20 (52.6%) male and 18
(47.7%) female patients (PCO MQ -12) with an average age of
52.02±16.61 years (Mdn=55 years, Ra=18–87 years) and
average score of 23.34±10.47 (Mdn=22, Ra=4-51). The
control group that completed COMQ-12 consisted of
10 (16.4%) male and 51 (83.6%) female volunteers with
an average age of 37±10.53 years (Mdn=35 years, Ra=41
years). They completed COMQ-12 twice within a two-day
interval, hence test (CTCOMQ -12) and retest (CRTCOM Q-1 2). The
average score was 1.410±3.111 (Mdn=0, Ra=20) for CTCO MQ -12
and 1.246±2.248 (Mdn=0, Ra=9) for CRTCOM Q-12 .
3.2 DHI and NVI
The DHI and NVI were each completed twice within a three-
day interval by identical groups comprising 26 (43.3%)
male and 34 (56.7%) female patients with an average
age of 61.4±13.8 years (Mdn=63.5 years, Ra=56 years).
The average score was 49.67±22.843 (Mdn=52, Ra=86)
for rst completion of the DHI (PTDHI) and 47.00±22.81
(Mdn=49, Ra=84) for the second completion (PRTDHI). The
average score was 65.07±18.78 (Mdn=65, Ra=80) for rst
completion of the NVI (PTNVI) and 64.52±18.88 (Mdn=65,
Ra=80) for the second completion (PRTNVI). The DHI and
NVI were completed by identical control groups comprising
28 (46.7%) male and 32 (53.5%) female volunteers with
an average age of 46.6±16.2 years (Mdn=45 years, Ra=51
years). The average score was 1.17±2.395 (Mdn=0, Ra=10)
for the DHI control group (CDHI) and 47.68±18.88 (Mdn=65,
Ra=80) for the NVI control group (CNVI).
3.3 THI
The THI was completed by 19 (31.7%) male and 41 (68.3%)
female patients (PTHI) with an average age of 53.80±13.7
years (Mdn=57 years, Ra=59 years) and an average score
of 52.12±23.50 (Mdn=51, Ra=88). The control group
completed the THI twice over an interval of a few days.
The THI was rst completed by 19 (31.7%) male and 41
(68.3%) female volunteers with an average age of 37±10.53
years (Mdn=35 years, Ra=41 years) as a test group (CTTHI).
The retest group (CRTTHI) consisted of three male (23.1%)
and ten female (76.9%) volunteers recruited from the CTTHI
with an average age of 47.4±13.5 years (Mdn=49 years,
Ra=52 years) and average score of 0±0 (Mdn=0, Ra=0).
3.4 Statistical Analysis
Test-retest reliability, discriminant validity, internal
consistency, ROC curve analysis and cut-off value for each
questionnaire are depicted in Table 1 and Figures 1, 2 and
3.
10.2478/sjph-2020-0016 Zdr Varst. 2020;59(3):120-127
123
Table 1.
Figure 1.
Figure 2.
Test-retest reliability, discriminant validity, internal consistency, cut-off value and Youden’s index for the COMQ-12, DHI, NVI
and THI.
COMQ-12 ROC curve.
DHI ROC curve.
Legend: α, Cronbach’s alpha; AROC, area under ROC curve; J, Youden’s index; p, p-value; *, Wilcoxon signed-rank test; **, type A
intraclass correlation coefcient estimates and their 95% condent intervals using an absolute agreement denition, based on single
measures and two-way mixed effects (ICCA); †, Mann-Whitney U test using an exact sampling distribution for U (Dineen & Blakesley,
1973); ‡, paired samples t-test; ‡‡, Welch’s t-test.
Commentary: statistical signicance is p<0.05. As the minimum NVI score is 28, the cut-off value is higher compared to the other
questionnaires.
Commentary: The area under the ROC curve (0.987) signies
outstanding diagnostic accuracy. A threshold score of 7 was
determined to distinguish between chronic otitis media and a
healthy ear. The ROC curve was created by plotting PCOMQ-12 and
CTCOMQ-12.
Commentary: The area under the ROC curve (0.999) signies
outstanding diagnostic accuracy. A threshold score of 9 was
determined for the recognition of vertigo. The ROC curve was
created by plotting PTDHI and CDHI.
COMQ-12
DHI
NVI
THI
p=0.680*, ICCA=0.858 (0.774–0.912)**
ICCA=0.946
(0.902–0.969)**
p=0.315‡, ICCA=0.975 (0.959–0.985)**
p=0.120*
p<0.0005 †
p<0.0005 †
p<0.0005 ‡‡
p<0.0005 †
0.796
0.910
0.950
0.924
0.987
0.999
0.781
1.000
7
9
56
7
0.90
0.95
0.43
1.00
JCut-off
value
AROC
α
Discriminant
validity
Test-retest reliability
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10.2478/sjph-2020-0016 Zdr Varst. 2020;59(3):120-127
125
Figure 3. Figure 4.
NVI ROC curve. THI ROC curve.
Commentary: The area under the ROC curve (0.781) signies
acceptable diagnostic accuracy. A threshold score of 56 was
determined for the recognition of vertigo. The ROC curve was
created by plotting PTNVI and CNVI.
Commentary: The area under the ROC curve (1.000) signies
perfect diagnostic accuracy. A threshold score of 7 was
determined for the recognition of tinnitus. The ROC curve was
created by plotting PTHI and CTTHI.
4 DISCUSSION
Each questionnaire had satisfactory test-retest reliability
as determined by the intraclass correlation coefcient,
the paired samples t-test or the Wilcoxon signed-rank
test. Furthermore, the Slovenian COMQ-12 had good-to-
excellent test-retest reliability, which was better than has
been reported recently (18, 56). The Slovenian DHI had
excellent test-retest reliability based on the intraclass
correlation coefcient. This is consistent with other
studies (32, 56). Since the NVI has only recently been
developed, to the best of our knowledge no studies have
yet been published regarding its test-retest reliability
(35, 57). Instead, the Slovenian NVI possesses excellent
test-retest reliability and contributes signicantly to the
current literature.
As in other studies, the discriminant validity was conrmed
for the Slovenian COMQ-12, DHI and THI using the Mann-
Whitney U test and for the Slovenian NVI using Welch
t-test by determining p>0.05 (5, 7, 53).
According to Cronbach’s alpha, the Slovenian DHI, NVI
and THI had perfect internal consistency, even higher
compared to other studies (7, 8, 32). The Slovenian COMQ-
12 had acceptable internal consistency.
To evaluate diagnostic accuracy and the cut-off value,
the area under the ROC curve (AROC) and Youden’s index
were determined for each questionnaire. The Slovenian
COMQ-12 and DHI had excellent, NVI acceptable and THI
perfect diagnostic accuracies according to AROC (58). There
is no similar data published for DHI, NVI and THI in other
languages regarding diagnostic accuracy and cut-off values
by determining AROC and Youden’s index.
5 CONCLUSION
The COMQ-12, DHI, NVI and THI questionnaires were
cross-culturally adapted and validated in the Slovenian
language for the rst time. The questionnaires can
be used in diagnosis or for evaluating the treatment
outcome. It is therefore an efcient and essential tool
for the comprehensive management of patients with
chronic otitis media, dizziness and tinnitus. They are
useful for general practitioners, occupational health
specialists, neurologists and otorhinolaryngologists. In
the future, the COMQ-12, DHI, NVI and THI questionnaires
could also assist a physician in their choice of the most
appropriate treatment modality, via their implementation
to disease-management guidelines. However, further
research is needed to substantiate the usefulness of
these questionnaires for different types of chronic otitis
media, vertigo and tinnitus. The relationships between
the questionnaires and other diagnostic tests should also
be considered. The Slovenian COMQ-12, DHI, NVI and THI
could be used in research into new treatment efcacies
10.2478/sjph-2020-0016 Zdr Varst. 2020;59(3):120-127
126
and into the impact of treatment on a patient’s health-
related quality of life. As we live in a digital era, the
future lies in electronic questionnaires, which are easier
to access and complete and aid the data analysis process.
ACKNOWLEDGEMENTS
John Phillips, Gary P. Jacobson, Emilia Lacroix and Craig
W. Newman for permission to translate the original COMQ-
12, DHI, NVI and THI, respectively.
CONFLICTS OF INTEREST
The authors declare that no conicts of interest exist.
FUNDING
There is no nancial interest or risk.
ETHICAL APPROVALS
Received from the Republic of Slovenia National Medical
Ethics Committee (Nos 0120-146/2019/5, 0120-032/2016-2
and 21/6/15)
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... Translations of the DHI Since its introduction the DHI has been translated into 22 different languages (Table 2). A multiple forward and backward translation procedure was used in 13 out of 24 studies (20,22,25,26,29,32,34,36,42,47,49,53,54). Cultural or textual adaptations were made in some translated versions of the DHI (26,32,35,51,58). ...
... No studies were found in which the primary goal was to assess the content validity of the English or translated versions of the DHI. However, the majority of studies which translated the DHI (20 out of 22) included some form of pilot testing for (one or more aspects of) the content validity, that is, relevance, comprehensiveness and/or comprehensibility (22,(25)(26)(27)29,32,34,35,37,38,42,43,(46)(47)(48)(49)51,54,57,58). We rated the methodological quality for these individual studies as ''doubtful,'' mainly because clear descriptions of the process of executing the cognitive interviews were lacking. ...
... Comprehensibility of the DHI was addressed in 20 translation studies (22,(25)(26)(27)29,32,34,35,37,38,42,43,(46)(47)(48)(49)51,54,57,58). Overall, the patients in these studies had no difficulty understanding or answering the questions. ...
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... The items 9-11 belong to factor 2, which describes environmental aspects of quality of life, and the items 4, 6-8, and 16 .832** 1.000 coefficient is a measure of the strength and direction of association between two variables, based on the rank of individual values instead of actual values; it is non-When the WB-HRQoL scores were compared between healthy study subjects and those having at least one chronic disease, they were significantly higher in the former: 79 [16] vs. 73 [19] (Mann Whitney U test, p<0.001). This confirms the instrument's discriminative ability. ...
... However, it is interesting that this domain encompassed also certain items that are traditionally linked to environmental aspect: adjustment to environmental temperature, air, and feeling of financial or safety in general. This is probably caused by specificity of western Balkan countries, which are extremely low-trust societies, where inhabitants either lack or have minimal trust in their governments and fellow citizens (19,20). In such cultural contexts people do not expect that their environment will be taken care of by institutions or other individuals, therefore HRQoL will depend on how they feel about their personal ability to cope with supposedly polluted air, inappropriate ambient temperature, crime, or financial instability. ...
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... It is a mixed generic and specific patient-reported instrument, with three broad symptom domains: hearing problems, daily activities, and acute disease activity (5). Since its development and initial validation in 2013, the COMQ-12 has been extensively translated and successfully applied to a diverse international patient population across different countries with distinct healthcare structures, socioeconomic factors, and cultural norms (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16). ...
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Purpose: To determine the efficacy of autologous platelet- and extracellular vesicle-rich plasma (PVRP) to treat chronic postoperative temporal bone cavity inflammation (CPTBCI) after exhausted surgical and standard conservative therapy. Materials and methods: Patients were randomly allocated to treatment with PVRP (PVRP group) or standard conservative methods (control group) in a setting of four once-monthly check-ups and subsequent follow-up. The treatment outcome was measured with COMQ-12 (chronic otitis media questionnaire-12), CPTBCI focus surface area, and CPTBCI symptom-free time after the fourth check-up. Results: 11 patients from each group completed the trial; 95% of patients suffered from chronically discharging mastoid cavity (the type of CPTBCI). Within four check-ups, the COMQ-12 score decreased statistically significantly in the PVRP group (p<0.001) but not in the control group (p=0.339). CPTBCI foci surface area decreased statistically significantly between the first and second check-ups (p<0.0005), but not between other check-ups (p>0.05) in the PVRP group. No statistically significant differences in CPTBCI foci surface area were detected between check-ups in the control group (p=0.152). Nine patients from the PVRP and three from the control group were CPTBCI symptom-free at the fourth check-up. The median symptom-free time was 9.2 months (95% CI [7.4, 11.9]) in the PVRP group. Cumulatively 49% of patients in the PVRP group remained CPTBCI symptom-free for 12.7 months after the fourth check-up. Conclusion: Autologous PVRP could represent an alternative method to treat chronically discharging radical mastoid cavity, which resembles chronic otitis media without cholesteatoma in its COMQ-12 scores and quality of life.
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Objective: Our study aimed to translate the chronic otitis media questionnaire-12 (COMQ-12) into the Arabic language, evaluate the internal consistency of the test and test-retest reliability, and validate the adaptation for further use in Arabic studies. Study design: A prospective observation monocenter cohort study. Settings: This study was done at Kafrelsheikh University Hospital, Egypt. Patients: One hundred twenty five ear pathology-free patients were asked to complete the questionnaire forming group A. One hundred twenty five patients with different forms of COM completed the questionnaire 2 weeks before the planned ear surgery and the same day of the operation, forming group B. Those patients who underwent the ear surgery, completed the questionnaire again 6 months after the operation forming group C. Intervention: We did an Arabic forward and backward translation of the original COMQ-12. The patients in group B underwent ear surgery (tympanoplasty with or without mastoidectomy). After fulfilling the questionnaire in different groups, we assessed the psychometric properties of the Arabic version of COMQ-12: internal consistency, reliability, reproducibility, validity, and responsiveness. Main outcome measures: Cronbach's α was 0.973. The Spearman's rank correlation coefficient was 0.981, while the Intraclass correlation coefficient was 0.973. Results: A statistically significant difference was present between group A (average total score 2.38 ± 1.543) and group B (average total score 35.86 ± 5.98). Also, there was a statistically significant difference between group B and group C (average total score 7.46 ± 8.294). The calculated cut-off point of the total score was more than or equal to eight. Conclusion: The cross-culturally Arabic adaptation of COMQ-12 was reliable, valid with strong internal consistency and responsiveness. It can detect the significant effect of COM on the quality of life of Arabic patients. This effect would be improved obviously after surgical management that markedly enhanced the preoperative hearing problem.
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Purpose The purpose of this study was to translate the low anterior resection syndrome (LARS) score into Slovenian and to test its validity on Slovenian patients who underwent low anterior rectal resection. Methods The LARS score was translated from English into Slovenian and then back-translated following international recommendations. The Slovenian version of the LARS questionnaire was completed by patients who underwent low anterior rectal resection between 1 January 2006 and 31 December 2010 at the University Medical Centre Ljubljana. An anchor question assessing the impact of bowel function on lifestyle was included. To assess test-retest reliability, some of the patients answered the LARS score questionnaire twice. Results A total of 100 patients (66.7%) of the 150 patients who were contacted for participation, were included in the final analysis. A total of 58 patients reported major LARS score. The LARS score was able to discriminate between patients who received radiotherapy and those who did not (p<0.001), and between total and partial mesorectal excision (p<0.001). Age was not associated with a greater LARS score (p=0.975). There was a perfect fit between the QoL category question and the LARS score in 66.0% of cases and a moderate fit was found in 24.0% of the cases, showing good convergent validity. Test-retest reliability of 51 patients showed a high intraclass correlation coefficient of 0.86. Conclusions The Slovenian translation of the LARS score is a valid tool for measuring LARS.
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The aim of the study was to examine the relationship between tinnitus pitch and maximum hearing loss, frequency range of hearing loss, and the edge frequency of the audiogram, as well as, to analyze tinnitus loudness at tinnitus frequency and normal hearing frequency. The study included 212 patients, aged between 21 to 75 years (mean age of 54.4 ± 13.5 years) with chronic subjective tinnitus and sensorineural hearing loss. For the statistical data analysis we used Chi-square test and Fisher's exact test with level of significance p < 0.05. Tinnitus pitch corresponding to the frequency range of hearing loss, maximum hearing loss and the edge frequency was found in 70.8%, 37.3%, and 16.5% of the patients, respectively. The majority of patients had tinnitus pitch from 3000 to 8000 Hz corresponding to the range of hearing loss (p < 0.001). The mean tinnitus pitch was 3545 Hz ± 2482. The majority (66%) of patients had tinnitus loudness 4-7 dB SL. The mean sensation level at tinnitus frequency was 4.9 dB SL ± 1.9, and 13 dB SL ± 2.9 at normal hearing frequency. Tinnitus pitch corresponded to the frequency range of hearing loss in majority of patients. There was no relationship between tinnitus pitch and the edge frequency of the audiogram. Loudness matching outside the tinnitus frequency showed higher sensation level than loudness matching at tinnitus frequency.
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Objective: The aim of this study was to translate the Chronic Otitis Media Questionnaire-12 (COMQ-12) into Turkish, evaluate the internal consistency of the test and test-retest reliability, and validate the adaptation for further use in Turkish studies. Methods: A total of 50 healthy subjects and 50 patients with chronic otitis media (COM) have completed a translated Turkish version of the COMQ-12. Healthy subjects were asked to complete the test twice. A statistical analysis was performed to evaluate the validity and test-retest reliability of the questionnaire. Patients were divided into three groups. Group 1 were patients with COM; Group 2 represented the first test of the control group; and Group 3 represented the second test of the control group. Cronbach's test was performed to test internal consistency, and Spearman's test was performed to evaluate test-retest validity. Results: The average score was 30.64 for Group 1, 3.60 for Group 2, and 3.66 for Group 3. The COMQ-12 score of the patient group was significantly higher than the score of the control group (p<0.001). The area under the receiver operating characteristics curve value was calculated as 0.992, which showed a strong diagnostic accuracy, and the cut-off point was defined as 9. A Cronbach's alpha value of 0.810 was found. Spearman's rank correlation coefficient value (Spearman's rho) was calculated as 0.920. Conclusion: The Turkish adaptation of the COMQ-12 is a consistent and valid test with high sensitivity and specificity that can be used in Turkish for further studies instead of the original questionnaire.
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The Dizziness Handicap Inventory (DHI) is believed to quantitate the handicap related to the presence or severity of underlying vestibular dysfunction. However, patients with chronic vestibular diseases may manifest various degrees of behavioural and physiological adaptation resulting in variances of the DHI. Our primary study objective is to evaluate the correlation between the DHI and measurable vestibular parameters. Secondarily, we compared DHI among different vestibular disorders (central, peripheral and functional), and different types of anatomic deficits (semicircular canal vs otolithic). We also correlated the DHI and posturography. We prospectively evaluated 799 patients with precise vestibular diagnoses using video head impulse testing (vHIT), caloric irrigation, and cervical/ocular vestibular-evoked myogenic potentials (c/oVEMP). Posturography was done for 84 patients. All participants completed the DHI. No significant correlation was found between DHI and (1) vestibulo-ocular reflex parameters: unilateral weakness r = − 0.018, total calorics r = 0.055, vHIT right r = 0.007, vHIT left r = − 0.091, vHIT asymmetry r = 0.013; (2) otolith parameters: cVEMP amplitude right r = − 0.034, amplitude left r = − 0.004, asymmetry r = 0.016; oVEMP amplitude right r = 0.044, amplitude left r = − 0.007, asymmetry r = − 0.008. Patients with central vestibular disorders had higher DHI than those with peripheral (z = − 4.743, p = 0.001) or functional disorders (z = − 2.902, p = 0.004). DHI of patients with deficits of canal or otolith function did not differ significantly from those with no deficits (z = 2.153, p = 0.541). There was no significant correlation between DHI and postural sway on posturography. Therefore, the DHI does not correlate with vestibular tests, and neither reflects the presence nor severity of peripheral vestibular deficits.
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Background Recently, demand for and supply of short-form patient-reported outcome measures (PROMs) have risen throughout the world healthcare. Our contribution to meeting that demand has been translating and culturally adapting the Chronic Otitis Media Questionnaire-12 (COMQ-12) for adults into Serbian and enhancing its psychometric base on the relatively large Serbian COM caseload. Chronic otitis media can seriously affect quality of life progressively and in long-term, and it remains the major source of hearing problems in the developing world. Methods The translated questionnaire was given twice to 60 adult patients with chronic otitis media of three types (inactive, active mucosal and active squamous disease) and to 60 healthy volunteers. Both patients and volunteers also filled the generic Short-Form 36 questionnaire (SF-36). Conventional statistical procedures were used in strategically driven development of scoring. Additionally, item responses were scaled by linear mapping against the provisional total score. Generalizability, detailed factor interpretation and supportability of scores were criteria, for the best compromise factor solution. Results Test-retest reliability was very high (0.924 to 0.989, depending on score). The a priori content dimensions of the questionnaire were strongly supported by 3-factor exploratory and confirmatory factor analyses for content validity, separating (i) ear symptoms from (ii) hearing problems, from (iii) daily activity restriction plus healthcare uptake. The 3-factor structure was furthermore highly stable on replication. The very large effect sizes when contrasting patients with healthy volunteers, and active with inactive disease established construct validity for the total score. A strong association with disease activity and a moderate one with generic health-related quality of life (HRQoL), the SF-36, supported construct validity for two of three factors extracted (ear symptoms, and impact on daily activities plus healthcare uptake). Conclusions Given the minimal psychometric work to date on COMQ-12, this interim sample with 120 data points adds materially to knowledge of its reliability, several forms of validity and the feasibility of profile sub-scores to supplement total scores. The good psychometric properties shown for COMQ-12 justify both its routine clinical use and acquisition of the necessarily larger sample for generality, score optimisation and the evaluation of responsiveness. Electronic supplementary material The online version of this article (10.1186/s12955-017-0782-x) contains supplementary material, which is available to authorized users.
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Purpose To cross-culturally adapt and validate Multiple Sclerosis Quality of Life-54 (MSQOL-54) instrument. Methods The study which enrolled 134 Slovenian multiple sclerosis (MS) patients was conducted from March to December 2013. The internal consistency of the MSQOL-54 instrument was evaluated by Cronbach’s alpha coefficient (α), and its dimensionality assessed by the principal component analysis (PCA). Results The whole instrument had high internal consistency (α=0.88), as well as the majority of its twelve subscales (α=0.83-0.94). The results of the PCA showed two components with eigenvalue greater than 1, explaining 59.4% of the cumulative variance. Further results indicated good construct validity of the instrument with the physical health-related-quality-of-life subscales loading highly on the physical component, and mental health-related-quality-of-life subscales loading highly on the mental component. Conclusion The Slovenian version of the MSQOL-54 instrument proved to be an internally consistent and accurate tool, well accepted by the Slovenian MS patients. The adequate psychometric properties warrant the scientifically sound version of the MSQOL-54 instrument, which is from now on at disposal to all health professionals dealing with MS patients in Slovenia.
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Neurophysiological measurements of the vestibular function for diagnosis and follow-up evaluations provide an objective assessment, which, unfortunately, does not necessarily correlate with the patients’ self-feeling. The literature provides many questionnaires to assess the outcome of rehabilitation programs for disequilibrium, but only for the Dizziness Handicap Inventory (DHI) is an Italian translation available, validated on a small group of patients suffering from a peripheral acute vertigo. We translated and validated the reliability and validity of the DHI, the Situational Vertigo Questionnaire (SVQ), and the Activities-Specific Balance Confidence Scale (ABC) in 316 Italian patients complaining of dizziness due either to a peripheral or to a central vestibular deficit, or in whom vestibular signs were undetectable by means of instrumental testing or clinical evaluation. Cronbach’s coefficient alpha, the homogeneity index, and test–retest reproducibility, confirmed reliability of the Italian version of the three questionnaires. Validity was confirmed by correlation test between questionnaire scores. Correlations with clinical variables suggested that they can be used as a complementary tool for the assessment of vestibular symptoms. In conclusion, the Italian versions of DHI, SVQ, and ABC are reliable and valid questionnaires for assessing the impact of dizziness on the quality of life of Italian patients with peripheral or central vestibular deficit.
Article
Objective: Tinnitus Handicap Inventory (THI) is one of the world’s most commonly used tools to assess tinnitus severity. The aim of the current study was to establish a revised THI grading system using standard Z-scores and percentiles. Design: Cross-sectional observational study. Study sample: Adult patients (1042 participants – 518 (49.7%) female and 524 (50.3%) male) reporting tinnitus duration of a minimum of 6 months with complete documentation on patient’s clinical status (age, gender, tinnitus duration and laterality, tinnitus handicap based on THI and hearing status based on pure-tone audiometry) were included in the study. Results: Multivariate analysis of variance was used to analyse the effects of gender and hearing loss on THI scores and revealed there was a significant effect of both. Consequently, separate grading systems for women and men, as well as for subjects with normal hearing and hearing loss, is proposed. Conclusions: Our findings are generally consistent with existing grading. Normative values proposed for THI scores, based on a large group of tinnitus patients, could be useful to guide decisions about appropriate intervention options or to evaluate treatment outcomes.
Article
Objective: Currently available patient reported outcomes questionnaires for dizzy patients give limited insight into the cognitive dysfunction patients often report. Using the newly developed English version of the neuropsychological vertigo inventory (NVI), we aimed to quantify the cognitive impairment of dizzy patients. Study design: Prospective cohort study. Setting: Tertiary neurotology clinic. Patients: Adults with vestibular diagnoses seen between June 2018 and October 2018. Patients with neurologic disorders affecting cognition were excluded. Interventions: None. Main outcome measure: NVI score. Secondary measures: dizziness handicap inventory (DHI) score, cognitive failure questionnaire (CFQ) score, 20-item short form health survey scores (SF20). Results: Of 67 subjects, 13 had BPPV, 11 had Menière's disease (MD), and 20 had vestibular migraine (VM). VM patients were significantly younger (43.5 versus 61.1 yrs, p = 0.016), and had significantly higher NVI (67.5 versus 51.0, p = 0.040) scores than BPPV patients. MD patients had significantly higher CFQ scores (44.8 versus 23.4, p = 0.015) than BPPV patients. NVI scores were similar between MD (67.3) and VM (67.5) patients (p = 1.000). DHI scores were similar for all patients (p = 0.102). NVI scores were highly correlated to CFQ scores (r = 0.864, p < 0.001). Conclusions: VM patients have levels of cognitive dysfunction similar to MD patients, but greater than BPPV patients. A lack of difference in DHI scores among these patients reflects its limitation in assessing the cognitive domain.
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Objective To raise awareness and propose a good practice guide for translating and adapting any questionnaire to be used for comparisons across populations divided by language or culture.Design Relevant methodological literature across ENT/Audiology and other healthcare fields was reviewed. The collective experience from the authors, members of the International Collegium of Rehabilitative Audiology and TINNET were also incorporated in this recommendation.Results Criteria for selecting an appropriate questionnaire were considered, followed by a set of guidelines for cross-cultural adaptation. Six steps promote a good-quality translation that is functionally equivalent to the original questionnaire and account for any cultural differences: 1) Preparation for translating a questionnaire, 2) The translation process – forward translation, 3) The translation process – back translation, 4) Committee review, 5) Field testing, and 6) Review and finalisation of the translation. Published examples illustrate how these steps have been implemented and reported. Conclusions Following this step-by-step guide can improve functional equivalence with the target-language version and promote quality assurance in multinational trials and outcome evaluations. A checklist of the preferred reporting items is included to help investigators make informed choices about conducting or omitting any items. We recommend using the checklist to document these decisions in any resulting publication.