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Italian version of Dyspnoea-12: cultural-linguistic validation, quantitative

and qualitative content validity study

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DOI: 10.23750/abm.v88i4.6341

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 Acta Biomed 2017; Vol. 88, N. 4: 426-434 DOI: 10.23750/abm.v88i4.6341 © Mattioli 1885

Original article

Italian version of Dyspnoea-12: cultural-linguistic

validation, quantitative and qualitative content validity
study
Rosario Caruso1, Cristina Arrigoni2, Katia Groppelli3, Arianna Magon1,
Federica Dellafiore1, Francesco Pittella1, Anna Maria Grugnetti4, Massimo Chessa5,
Janelle Yorke6
1
Health Professions Research and Development Unit, IRCCS Policlinico San Donato, San Donato Milanese, Italy; 2 De-
partment of Public Health, Experimental and Forensic Medicine, Section of Hygiene, University of Pavia, Pavia, Italy; 3 Azien-
da Socio-Sanitaria Territoriale di Pavia, Mede, Italy; 4 Fondazione IRCCS Policlinico San Matteo Pavia, Pavia, Italy; 5 Pediatric
and Adult Congenital Heart Disease Center, IRCCS Policlinico San Donato University Hospital, San Donato Milanese, Italy;
6
School of Nursing, Midwifery and Social Work, University of Manchester, United Kingdom

Summary. Background: Dyspnoea-12 is a valid and reliable scale to assess dyspneic symptom, considering its
severity, physical and emotional components. However, it is not available in Italian version due to it was not
yet translated and validated. For this reason, the aim of this study was to develop an Italian version Dysp-
noea-12, providing a cultural and linguistic validation, supported by the quantitative and qualitative content
validity. Methods: This was a methodological study, divided into two phases: phase one is related to the cultural
and linguistic validation, phase two is related to test the quantitative and qualitative content validity. Linguis-
tic validation followed a standardized translation process. Quantitative content validity was assessed comput-
ing content validity ratio (CVR) and index (I-CVIs and S-CVI) from expert panellists response. Qualitative
content validity was assessed by the narrative analysis on the answers of three open-ended questions to the
expert panellists, aimed to investigate the clarity and the pertinence of the Italian items. Results: The transla-
tion process found a good agreement in considering clear the items in both the six involved bilingual expert
translators and among the ten voluntary involved patients. CVR, I-CVIs and S-CVI were satisfactory for all
the translated items. Conclusions: This study has represented a pivotal step to use Dyspnoea-12 amongst Ital-
ian patients. Future researches are needed to deeply investigate the Italian version of Dyspnoea-12 construct
validity and its reliability, and to describe how dyspnoea components (i.e. physical and emotional) impact the
life of patients with cardiorespiratory diseases. (www.actabiomedica.it)

Key words: breathlessness, dyspnea, scale, translation, validity

Introduction (e.g. pain perception, fatigue, depression and anxiety),

affecting patients overall quality of life (QoL) (1-5).
Dyspnoea is a subjective symptomatic manifesta- Hence, dyspnoea assessment is a key element of its
tion, typically defined as a complex and multidimen- management and identification of correct clinical
sional experience (1, 2). It is commonly described as pathways of patients with cardiorespiratory diseases
a distressing symptom, which is often associated with (6, 7). Thus, dyspnoea is considered a cardinal symp-
a wide range of physical and emotional consequences tom for its prognostic value (6), and even considering

09-caruso.indd 426 15/01/18 14:39

 Dyspnoea-12 Italian validation 427

that its correct management has an impact on the dis- Methods

ease treatment efficacy (8).
Dyspnoea is typically assessed using direct or This was a methodological study, divided into two
indirect approaches. The most common direct assess- phases: phase one is related to the cultural and linguis-
ments are represented by visual analogue scales or by tic validation, phase two is related to test the quantita-
the modified Borg index (9). However, such approach- tive and qualitative content validity.
es are limited by the mono-dimensional nature of the
measurements, which often use single-item scales that Scale description
do not capture the complexity of this multidimen-
sional symptom. Indirect approaches assess the level Dyspnoea-12 uses 12 items (i.e. symptom descrip-
of physical activities that patients are not able to ac- tors) to assess the overall severity of dyspnoea, also giv-
complish due to their dyspnoeic symptomatology (2) ing a quantification of its physical and psychological
or capture the impact of dyspnoea to the patient’s QoL dimensions (i.e. scale domains). Each item is rated us-
(10). Such scales provide useful information but they ing a four-point Likert scale (from zero to three), and
do not measure dyspnoea per se. the dyspnoea severity is computed summing each item
More recently, the development of the Dysp- response. Thus, Dyspnoea-12 total score ranges from 0
noea-12, a brief self-report scale has addressed the to 36, where higher values indicate more severe dysp-
abovementioned limitations to provide a measure of noeic symptoms. The physical domain is computed
dyspnoea that incorporates its multidimensional com- summing the first seven items, while the psychological
ponents. Dyspnoea-12 was developed using dyspnoea one (i.e. emotional domain) is computed summing the
descriptors identified in a comprehensive literature re- items 8-12 (2, 3, 12, 13).
view of the language used by patients to describe the
experience of breathlessness (2). The initial pool of 81 Phase one: cultural and linguistic validation
items was reduced to 12, using hierarchical methods
and Rach analysis (2). Dyspnoea-12 has been vali- Importing Dysponea-12 for the Italian use has
dated for use in different clinical situations and across required a considerable effort by researchers to main-
many cardiorespiratory conditions (2, 3, 11). tain the quality of translation, for this reason the
Dyspnoea-12 is currently available for English methodology of this phase strictly followed an adap-
speaking populations (i.e. original version) (2) and in tation of the Brislin’s classic translation model (18),
Arabic (11) and others not yet published ( JY personal which was described by Jones et al. (19). According
correspondence). Although many scales are available to Jones et al. (2001), this phase was performed with
to assess dyspnoea in patients with different cardiores- a combined translation technique which uses a group
piratory diseases (e.g. HF, COPD, cancer, asthma) (9, approach when applying the back-translation method
14-17), Dyspnoea-12 has a number of advantages: and bilingual technique. The setting of phase one was a
(a) scale briefness (2); (b) clear reliability and psycho- teaching hospital of northern Italy, and this phase was
metrics proprieties (i.e. construct validity) in COPD performed from August to October 2016. The transla-
(2), asthma (12), interstitial lung disease (13), lung tion process is schematically described in Figure 1.
cancer (1), and pulmonary hypertension (3); (c) it is At the beginning of the process, a project man-
the unique single scale which measure not only the ager (RC) was identified by the research team to
symptom severity, but also the physical and emotional control the rigor of the overall translation. Then, two
symptom components (2, 3, 11, 12, 13). bilingual experts (one physician and one nurse) have
The aim of the current study was to develop an prepared two translated versions of Dyspoea-12 from
Italian version Dyspnoea-12 and assess its content va- English to Italian. Each Italian version was blindly
lidity. back translated to the English by two other bilingual
experts (one physician and one psychologist). The
four bilingual experts had a consensus group discus-

09-caruso.indd 427 15/01/18 14:39

 428 R. Caruso, C. Arrigoni, K. Groppelli, et al.

English speaker translator (nurse), but even speaking a

certified fluent Italian language. The back-translation
is reviewed against the English version of the Dysp-
noea-12 by the project manager (i.e. back translation
review). The project manager has passed the back
translation review report to the correspondence au-
thor of the original scale to receive any suggestions or
possible issues, which should be solved to refine the
translation.
After the endorsement on the back translation
review, given by the correspondence author of the
original scale ( JY ), the Italian scale version was tested
on voluntary patients to ensure that the language and
concepts expressed were clearly understandable (i.e.
pilot testing). Thus, the translation was given to ten
voluntary outpatients, using a convenience sampling.
The patients have filled the translated Dyspnoea-12.
Then, they have rated the clarity of each item, us-
ing a Likert scale from one to five (1=completely
not clear; 5=completely clear). Further, the project
manager has also asked them four questions aimed to
check their comprehension of each translated items.
The questions were: (a) Do you understand this? (b)
What does this mean to you? (c) Can you explain it in
your own words? (d) Can you suggest any alternative
wordings?
The answers to these questions, along with any
other relevant comments and suggestions, were tran-
Figure 1. Schematic flow chart of the standardized translation scribed Verbatim and analysed using a narrative analy-
process of the Dyspnoea-12
sis technique (20) to summarize the main emerging
themes into a report. The project manager has reviewed
sion, involving other two bilingual members (another the pilot-testing report and any eventual issues. When
nurse and one patient), and aimed to ensure the best each issue was solved, the translation was formatted
cultural equivalence, using the most comprehensible into the same format as the English version, and sent
Italian wording for each translated item, identifying to the correspondence author of the original scale for
the possible differences between the Italian and Eng- her final endorsement.
lish versions. At the end of the consensus discussion,
the project manager has assessed the degree of con- Phase two: quantitative and qualitative content validity
sensus by the use of an inter-rater agreement index
(i.e. Fleiss’ Kappa), asking to the experts to rate each The translated Dyspnoea-12 was also tested for
Italian-translated item with a Likert scale from one to quantitative and qualitative content validity.
five (1=completely not agree; 5=completely agree). The The quantitative content validity followed the
consensus was considered good when the agreement methodology developed in the 1970s by Lawshe (21).
among raters was higher than 0,80 . The aim was to assess agreement among raters regard-
Then, Italian Dyspnoea-12 version was back- ing how pertinent is each item in relation to the objec-
translated into English again by an independent native tive of its measurement. Qualitative content validity

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 Dyspnoea-12 Italian validation 429

(i.e. face validity) aimed to explore patients under- faele (Italy) (Protocol n.112/INT/2016). The research
standing of the items and their views about the overall methodology was in full accordance with international
concept that they purport to measure (22). ethical principles, Italian legal and research ethics re-
The quantitative content validity was assessed us- quirements for non-interventional studies. All the par-
ing the viewpoints of a panel of experts, consisting in ticipants (i.e. patients, nurses, physicians, translators)
20 raters (i.e. 12 physicians, eight nurses). Their evalu- were informed about the aims and the method of the
ation was firstly based on a three-point Likert scale study, and they were asked to provide written informed
(1= not necessary; 2=useful but not essential; 3=essen- consent, as required in the Italian Legislative Decree
tial) to computed the content validity ratio (CVR). Its n. 196 of 30th June 2003. Participants of each phase
formula is CVR=(Ne - N/2)/(N/2), in which the Ne is were also informed about the confidentiality of their
the number of raters indicating “essential” and N is the responses and anonymity in data elaboration for the
total number of raters (21). CVR could varies between final report of the study.
+1 and -1. Higher score indicates further agreement
among raters on the necessity to keep the evaluated
item in the scale. Secondly, the panel of experts was Results
asked to rate translated Dysponea-12 items in terms of
its relevancy to the construct underlying the scale using Phase one: cultural and linguistic validation
a four-point ordinal scale (1=not relevant; 2=somewhat
relevant; 3=quite relevant; 4=highly relevant). CVI was The consensus discussion lasted approximately 90
calculated both for the items level (I-CVIs) and for the minutes. The characteristics of participants included in
scale-level (S-CVI). To obtain the relevancy of each the consensus discussion are shown in Table 1. Partici-
item (I-CVIs), the number of those judging the item pants were mainly male (n=5; 83,3%) and median age
as relevant (i.e. ratings ≥3) was divided by the number was 44,8 years (IQR=9,1). According to the combined
of content experts. Thus, I-CVIs were computed as the translation technique (19), participants discussed the
number of experts giving a rating 3 or 4 to the relevancy two prior translations and back-translations, trying to
of each item, divided by the total number of experts, and ensure the equivalence of the concepts. Finally, par-
expressing the proportion of agreement on the relevancy ticipants rated each translated item to assess consensus
of each item, where the index could range between zero in the items’ wording choice. All ratings were higher
and one (23). Furthermore, S-CVI was defined as the than four on a five-point Likert scale (1=completely
proportion of total items judged content validity (23), not agree; 5=completely agree). As shown in Table 2,
and it was computed as the average of the I-CVIs. the Fleiss’ K was 0,95 and it was computed consider-
To obtain the qualitative content validity, the ing two categories (i.e. 4 and 5 rates), 12 cases (i.e.
authors asked to the same panel of expert (n=20) to items) and six raters.
answer to three open-ended questions, transcribed Back-translation by an independent native Eng-
Verbatim. The questions were aimed to explore the lish speaker did not show any significant differences
difficulty level of the items’ wording, desired relation- with the original scale; thus the original scale develop-
ship between items and the main objective of Dysp- er endorsed the translated items. Pilot testing provided
noea-12, eventually to discuss about ambiguity and further information about the clarity of the wording of
misinterpretations of items. All the answers were ana- individual items (see table 1 for participant character-
lysed using a narrative analysis (20) to summarize the istics). The ratings indicated high agreement between
main emerging themes. the English and Italian meaning for each item (Fleiss’
K=0,81). Moreover, participants commented on the
Ethical considerations ‘simplicity’ in understanding the meaning of each item.
The translated items of Phase 1 are show in Table 4
This study obtained the approval from the Re- (i.e. items in italics).
search & Ethical Committee of Ospedale San Raf-

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 430 R. Caruso, C. Arrigoni, K. Groppelli, et al.

Table 1. Participants characteristics (Phase 1)

N %
Consensus discussion participants n = 6 Gender Male 5 83,3
Female 1 16,7
Profession Physician 2 33,3
Psychologist 1 16,7
Nurse 2 33,3
Retired 1 16,7
Marital status Married 6 100
Education Master Degree 4 66,6
Ph.D. 2 33,4
Median IQR
Age (years) 44,8 9,1
N %
Pilot testing participants n = 10
Gender Male 6 60
Female 4 40
Profession Retired 7 70
Employed 3 30
Marital status Married 8 80
Unmarried 2 20
Education University 4 40
High school 4 40
Lower than higher school 2 20
Principal disease HF 6 60
COPD 4 40
Median IQR
Age (years) 66,4 6,2

Phase two: quantitative and qualitative content validity dyspnoea in our patients, identifying both the physical and
emotional aspects, besides its severity”. Another example
Twenty patients participated in phase two (see ta- of comment that has shaped the theme ‘outrifhtness’
ble 3 for characteristics). The first quantitative content was (expert OG): “[...] It’s brilliant, items are immedi-
validity was assessed by CVR calculation and indicted ately understandable and direct”.
that all the items were considered relevant (all CVRs
higher than 0,70) and appropriate (see table 5).
The narrative analysis on the experts’ answers Discussion
to the three open-ended questions shows two main
themes: ‘usefulness’ and ‘outrightness’. For example, a The aim of this study was to develop and assess
comment (expert SC) that has shaped the theme ‘use- content validity of the Italian version of Dyspnoea-12.
fulness’ was: “[…] we need a scale like the one you are Thus, the methodology of this study was designed
validating, due to it could be very useful to rapidly assess to ensure the best cultural and linguistic translation,

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 Dyspnoea-12 Italian validation 431

Table 2. Consensus discussion and pilot testing Items’ ratings (Phase 1)

N of rating=4 N of rating=5 Fleiss’ K#
Consensus discussion items ratings Item 1 0 6 0,95
(6 participants) Item 2 0 6
Item 3 0 6
Item 4 0 6
Item 5 0 6
Item 6 0 6
Item 7 0 6
Item 8 0 6
Item 9 3 3
Item 10 0 6
Item 11 0 6
Item 12 0 6

N of rating=3 N of rating=4 N of rating=5 Fleiss’ K§

Pilot testing items ratings (10 participants) Item 1 0 1 9 0,81
Item 2 0 1 9
Item 3 0 0 10
Item 4 0 1 9
Item 5 0 0 10
Item 6 0 2 8
Item 7 0 1 9
Item 8 1 0 9
Item 9 1 1 8
Item 10 0 2 8
Item 11 0 1 9
Item 12 0 0 10
Legend:
#
Fleiss’ K was computed considering 2 categories (i.e. rating=4; rating=5), 12 cases (i.e. 12 items) and 6 raters
§
Fleiss’ K was computed considering 3 categories (i.e. rating=3; rating=4; rating=5), 12 cases (i.e. 12 items) and 10 raters

Table 3. Participants characteristics (Phase 2) The core of the standardized translation process
N % (19) was the consensus discussion, where the experts
forward-translated the previous two back-translated
Gender Male 11 55
Female 9 45 versions, discussing about the best cultural equivalence
of the Italian translation. This methodology was in line
Profession Physician 12 60
Nurse 8 40 with a previous Arabic translation of Dyspnoea-12
(11), and as even in Italian translation there were no
Marital status Married 17 85
Unmarried 3 15 items or terms problematic to translate. This could
be explained because Dyspnoea-12 items are easy to
Median IQR
understand with clear concept elaboration and defini-
Age 41,6 6,3 tions shared between the author of the original ver-
sion and the project manager of the target language.
maintaining the original concept equivalence (19). Moreover, the pilot testing confirmed the clarity of the
Indeed, the assessment of quantitative and qualitative translation.
Italian version content validity supported the trans- Considering CVR evaluation, item 8 was the only
lated version, providing a solid basis for future imple- item with a borderline value (i.e. 0,70), but considered
mentations in clinical and research settings. to be relevant by from the panellists perspective. Fur-

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 432 R. Caruso, C. Arrigoni, K. Groppelli, et al.

Table 4. CVR calculation

Expert panel (N=20) Ne CVR Interpretation
item 1
My breath does not go in all the way
(Non mi sento capace di respirare a pieni polmoni) 19 0,90 Relevant
item 2
My breathing requires more work
(Devo forzare il respiro per riempire i polmoni) 18 0,80 Relevant
item 3
I feel short of breath
(Sento di avere il fiato corto) 18 0,80 Relevant
item 4
I have difficulty catching my breath
(Ho difficoltà nel trattenere il respiro) 18 0,80 Relevant
item 5
I cannot get enough air
(Non riesco a prendere aria a sufficienza) 19 0,90 Relevant
item 6
My breathing is unconfortable
(Il mio respiro è fastidioso) 20 1,00 Relevant
item 7
My breathing is exhausting
(Il mio respiro mi stanca) 18 0,80 Relevant
item 8
My breathing makes me feel depressed
(Il mio respiro mi butta giù di morale) 17 0,70 Relevant
item 9
My breathing makes me feel miserable
(Il mio respiro mi fa sentire di cattivo umore) 19 0,90 Relevant
item 10
My breathing is distressing
(Il mio respiro mi stressa) 20 1,00 Relevant
item 11
My breathing makes me agitated
(Il mio respiro non mi fa riposare bene) 19 0,90 Relevant
item 12
My breathing is irritating
(Il mio respiro mi rende irritabile) 20 1,00 Relevant
Note: Italian version is in italics

thermore, all items were high rated by the panellists content validity (24); which showed a good response
for their pertinence evaluation (I-CVI and S-CVI). from the panellists.
These results provide solid support to the Italian The main limitation of the adopted methodology
translated Dyspnoea-12. As with every cross-cultural is previously described in relation to the possible diffi-
and international collaborative studies, Dyspnoea-12 culty to reach agreement during the consensus discus-
translation also required assessment for its qualitative sion (25). However, we did not experience such dif-

09-caruso.indd 432 15/01/18 14:39

 Dyspnoea-12 Italian validation 433

Table 5. Calculation of I-CVI and S-CVI.

Expert panel (N=20)
Relevant Not Relevant I-CVI Interpretation S-CVI
(ratings ≥3) (ratings ≤2)
item 1 18 2 0,90 Appropriate
item 2 17 3 0,85 Appropriate
item 3 18 2 0,90 Appropriate
item 4 17 3 0,85 Appropriate
item 5 19 1 0,95 Appropriate
item 6 20 0 1,00 Appropriate 0,90
item 7 16 4 0,80 Appropriate
item 8 19 1 0,95 Appropriate
item 9 17 3 0,85 Appropriate
item 10 18 2 0,90 Appropriate
item 11 19 2 0,95 Appropriate
item 12 18 2 0,90 Appropriate

ficulty since our consensus discussion reached a very or inpatients settings), and for researches purposes.
good agreement level (Fleiss’ K=0,95). The main limi- Healthcare professionals should objectively assess
tation is related to the nature of bilingual technique their patients’ symptoms to implement tailored clinical
translation. It could be related to the possibility that pathways (26). Hence, future researches are needed to
bilingual people are acculturated to their host culture, deeply investigate the Italian version of Dyspnoea-12
so they could report different response from monolin- construct validity and its reliability, and to describe
gual people during consensus discussion (25). how dyspnoea components (i.e. physical and emotion-
Future investigations could are needed to pro- al) impact the life of patients with cardiorespiratory
vide evidence of the Italian version of Dyspnoea-12, diseases.
psychometric properties. Following that work, the
validate Dyspnoea-12 Italian version may be used to
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worth HB, Coan A, et al. Assessment of the psychometric Fax +39 0252774969
properties of an English version of the cancer dyspnea scale E-mail: rosario.caruso@grupposandonato.it

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