CHECKLIST FOR REVIEWERS/AUTHORS FOR STUDIES ON THE TRANSLATION
AND CROSS-CULTURAL ADAPTATION OF QUESTIONNAIRES/ASSESSMENT
INSTRUMENTS
Cross-cultural adaptations are required for the application of questionnaires or
guidelines that have been well-established in the literature and translated from different
languages, cultures, and countries. The process of cross-cultural adaptation includes
translation and cultural adaptation to ensure equivalence between the original
instruments/questionnaires/guidelines and the Brazilian Portuguese version.
A few items are suggested below to guide the assessment of manuscripts on
translation and cross-cultural adaptation based on the cross-cultural adaptation guide
by Beaton et al. (2000), which consists of 5 stages. Each stage contains the
requirements needed to guarantee the quality of the translation and adaptation
process. All items of the questionnaire/assessment guidelines, alternative answers,
and instructions must undergo the cross-cultural adaptation process. Therefore, in the
natural order of the review process, the editor, statistics editor, and reviewer must
verify whether the authors have met all of the criteria described below for each
decision-maker:
Instructions to reviewers/authors:
- Stage I: Translation into Portuguese:
 Did the authors mention the presence of at least two translators?
 Were the bilingual translators native speakers of Brazilian Portuguese?
 Did the translators have different professional backgrounds and profiles (i.e. one
translator has knowledge of the concepts assessed by the instrument and the other is
not related to the health area)?
 Did the translators work on the translation independently?
 Did the authors describe the translator’s questions or changes and the rationale behind
the translation?
- Stage II: Synthesis of translation
 Were the translators involved in the reporting of the process?
 Were the translated versions compared to the original questionnaire to extract a
synthesis of the first Portuguese version of the questionnaire (version I)?
 Did the authors present a report of the synthesis process containing the questions that
required changes and how they were resolved?
 Was there mention of the process of consensus between the translators?
- Stage III: Back translation
 Was version I of the translated questionnaire translated back into the original
instrument’s language?
 Were at least two translators involved?
 Were the bilingual translators native speakers of the original instrument’s language?
 Did the authors ensure that the translators were not familiar with the original version of
the questionnaire?
 Did the authors ensure that these translators did not have a background in the area of
health or information about the concepts explored by the questionnaire or instrument?
- Stage IV: Expert committee
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 Did the Committee include methodologists, health professionals, language
professionals, and translators (Stage I and II translators and Stage III back
translators)?
 Were the authors of the original questionnaire contacted and did they grant approval
for the cross-cultural adaptation? (Required)
 Is there mention of the participation of the authors of the original questionnaire during
this stage? (Not required)
 Did the consolidation of a pre-final version consider all reports, translations, and back
translations?
 Is there mention of the aspects that required changes at this stage and of how they
were resolved?
 Were the Committee’s decisions aimed at ensuring semantic, idiomatic, experimental,
and conceptual equivalence between the versions?
- Stage V: Pre-test of pre-final version
 Was the pre-final version tested on at least 30 subjects?
 Were these subjects part of the target population of the assessed questionnaire or
instrument?
 Did every subject answer the questionnaire or instrument and was each one
interviewed to explore their comprehension of each item and answer of the
questionnaire? Guillemin et al. (1993) suggest posing the question: “What did you
mean?” to assess their understanding of the item.
 Did the authors report the percentage of uncertainties during this part of the process
(pre-final version)? Uncertainties reported by 15 or 20% or more of the sample indicate
the need for revision of the questionnaire (Ciconelli et al., 1999; Nusbaum et al., 2001).
If the percentage is greater than 15% or if more subjects were included, the translated
and adapted version of the questionnaire or instrument must be changed and a new
pre-test must be conducted and reported.
 For original instruments already established in the literature and whose construct has
been assessed, the authors should briefly describe the results of this assessment.
Otherwise, the authors of the current version must assess the construct using the data
from the translation.
 We recommend that the original instrument be submitted with the manuscript as a
separate file.
Instructions to Editor or Area Editor:
 Did the authors mention that they followed the guidelines by Beaton et al.
(2000) during the process of cross-cultural adaptation?
 Did
the
items,
alternative
answers,
and
instructions
of
the
instrument/questionnaire/guidelines also undergo the process of cross-cultural
adaptation?
 Have the authors included the adapted version of the questionnaire or
guidelines?
 Did the authors include the reference for the original questionnaire or guidelines
in the text?
If the answer to any of the above items is ‘No’, the manuscript must be rejected and
the authors should be encouraged to follow the instructions on the BJPT website.
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Instructions to the Statistics Editor:
 Did the authors perform adequate and comprehensive statistical analyses to
assess the psychometric properties pertaining to the type of questionnaire or
guidelines?
The process of cross-cultural adaptation does not ensure that the psychometric
characteristics of the questionnaire will be preserved. The psychometric properties
must be tested after cultural adaptation. The analysis of the report of the psychometric
property assessment must take into account the following items:
Required Items:
1)
Reproducibility or Test-retest of the application of the instrument – The
questionnaire must be applied in two distinct situations to ensure independence
between the assessments and stability of the clinical situation/event that is being
assessed. To verify reliability: use of Intraclass Correlation Coefficient (ICC - two-way
random effects model) for continuous variables and the weighted kappa test for ordinal
data. To verify agreement: standard error of the mean (SEMagreement) or the BlandAltman or limits of agreement method (Terwee et al., 2007). Minimum sample size: 50
subjects. ICC and Kappa values of at least 0.70.
2)
Internal Consistency using Cronbach’s alpha. For multidimensional instruments,
the alpha for each subscale must be described. A minimum sample size of 100
subjects is required for this phase or the ratio of 4 to 10 times the number of
questions/items can be employed.
Recommended item
3)
Analyses for instruments based on the Classical Test Theory (multidimensional
reflexive models) – Exploratory factor analysis if the factor model (dimensions of the
instrument) has not been verified in the original scale. Confirmatory Factor Analysis to
verify the model if the instrument in the original language has already been submitted
to exploratory factor analysis. Analyses for instruments based on the Item Response
Theory (unidimensional models and constructs related to measurement of
skills/aptitude) - Rasch Analyses. For factor analyses, we recommend a sample of 100
subjects (4 to 10 times the number of questions/items) (Terwee et al., 2007). For
Rasch analyses, the minimum sample size must be 100 subjects (Chen et al., 2014).
Checklist – Submission of studies on translations and crosscultural adaptations and validation
Items of translation and cross-cultural adaptation
Author
Mark with
an X
1 - Title mentions that it is a translation and cross-cultural adaptation.
2 - Reference to original instrument was included in Methods.
3 - Reference to original instrument was included in References.
4 - Translated instrument was included in full at the time of
submission.
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Reported
on page
no.
Reviewer
Mark with
an X
5 - Original instrument was submitted in full.
6 - Authorization was given by the authors of the original instrument.
7 - Guidelines by Beaton et al. (2000) were followed in the translation
and adaptation stages and the authors clearly mention the use of this
guideline.
Translation - 2 translators (1 lay translator and 1 specialized in the
area).
Meeting of translation committee (synthesis of translation).
Back translation - 2 lay translators.
Meeting of expert committee.
Test of pre-final version (n>30).
Rate of comprehension was described in the test of the pre-final
version – uncertainties reported by 15 or 20% or more of the sample
indicate the need for revision of the questionnaire (Nusbaum et al.,
2001).
8 - All items of the questionnaire were translated and cross-culturally
adapted, including alternative answers and instructions.
9 - A clear description was given of the cultural adaptations made
during the study.
10 - A clear description of the sample characteristics was included in
the stages of the study.
Measurement properties
Required
11 - Was the translated instrument’s reproducibility (test-retest)
assessed?
12 - Was the sample size adequate for assessment of the
reproducibility? (Terwee et al., 2007)
13 - Was the translated instrument’s internal consistency assessed?
14 - Was the sample size adequate for assessment of the internal
consistency? (Terwee et al., 2007)
Recommended
15 - Was confirmatory factor analysis of the translated instrument
conducted?
16 - Was the sample size adequate (Mokkink et al., 2010) for
confirmatory factor analysis of the translated instrument?
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OR
17 - If exploratory factor analysis was not conducted in the original
study, was it conducted in the translation study?
18 - Was the sample size adequate (Mokkink et al., 2010) for
exploratory factor analysis of the translated instrument?
References
- Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of
cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976).
2000;25(24):3186-3191.
- Ciconelli RM, Ferraz MB, Santos W, Meinão I, Quaresma MR. Tradução para Língua
Portuguesa e validação do questionário genérico de avaliação de qualidade de vida
SF-36. Revista Brasileira de Reumatologia. 1999;39:143-150.
- Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related
quality of life measures: literature review and proposed guidelines. J Clin Epidemiol.
1993;46(12):1417-1432.
- Nusbaum L, Natour J, Ferraz MB, Goldenberg J. Translation, adaptation and
validation of the Roland-Morris questionnaire. Braz J Med Biol Res. 2001;34(2):203210.
- Chen WH, Lenderking W, Jin Y, Wyrwich KW, Gelhorn H, Revicki DA. Is Rasch
model analysis applicable in small sample size pilot studies for assessing item
characteristics? An example using PROMIS pain behavior item bank data. Qual Life
Res. 2014 Mar;23(2):485-93.
- Terwee CB1, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM,
de Vet HC. Quality criteria were proposed for measurement properties of health status
questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42.
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