Linguistic validation is the process of investigating the reliability, conceptual equivalence, and

content validity In psychometrics, content validity (also known as logical validity) refers to the extent to which a measure represents all facets of a given construct. For example, a depression scale may lack content validity if it only assesses the affective di ...

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH
"Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims"
December 2009 of translations of patient-reported outcome (PRO) measurements.

Methodology

Usually, linguistic validation is a process whereby translated text is tested with

patients A patient is any recipient of health care services that are performed by healthcare professionals. The patient is most often ill or injured and in need of treatment by a physician, nurse, optometrist, dentist, veterinarian, or other healt ...

in a target population and target-language group via cognitive-debriefing interviews. For example, if a PRO instrument were intended to measure the

symptoms Signs and symptoms are diagnostic indications of an illness, injury, or condition. Signs are objective and externally observable; symptoms are a person's reported subjective experiences. A sign for example may be a higher or lower temperature ...

diabetes Diabetes mellitus, commonly known as diabetes, is a group of common endocrine diseases characterized by sustained high blood sugar levels. Diabetes is due to either the pancreas not producing enough of the hormone insulin, or the cells of th ...

in a trial in

Denmark Denmark is a Nordic countries, Nordic country in Northern Europe. It is the metropole and most populous constituent of the Kingdom of Denmark,, . also known as the Danish Realm, a constitutionally unitary state that includes the Autonomous a ...

, the linguistic-validation interviews would be conducted with diabetic patients in Denmark who speak Danish as their

mother tongue A first language (L1), native language, native tongue, or mother tongue is the first language a person has been exposed to from birth or within the critical period. In some countries, the term ''native language'' or ''mother tongue'' refers ...

. This interview exercise ensures that items are appropriate for use in the target population, and are clearly expressed and understood.Gawlicki, Mary C.; Handa, Melissa; McKown, Shaw
Corporate Translations, Inc."The Linguistic Validation of the Lupus Quality of Life (LupusQoL) Questionnaire"
2009 The exercise is also an important tool for demonstrating content validity when compared with the source. During the interview, the respondents complete the questionnaire, and then answer a series of open-ended questions on its content and explain in their own words what they think each item means. The results of this cognitive-debriefing exercise should therefore show the respondents' understanding of the translation, and alterations can be made after this stage if nuances of meaning in the source text have not been expressed clearly in the translation and understood by the respondents. The process also ensures multi-lingual harmonization of the translations, by making sure that the questionnaire is understood the same way by target populations across all language groups, thus ensuring that the resulting quantitative data can be compared across language groups. An alternative method of conducting linguistic validation is to ask a clinician who specialises in working with the target population to review the text, to ensure that it is clearly understandable. The clinician's understanding and knowledge of the usual

terminology Terminology is a group of specialized words and respective meanings in a particular field, and also the study of such terms and their use; the latter meaning is also known as terminology science. A ''term'' is a word, Compound (linguistics), com ...

and

phrases In grammar, a phrasecalled expression in some contextsis a group of words or singular word acting as a grammatical unit. For instance, the English expression "the very happy squirrel" is a noun phrase which contains the adjective phrase "very ...

used by the patient group can be utilised, thus ensuring that the wording used in the translation reflects that which would be used by the target patient group themselves. Some parties feel that this step is sufficient to validate a PRO translation. However,

regulatory Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. Fo ...

authorities consider it preferable to validate measures through the above-mentioned cognitive debriefing with the patients in the target population where possible, and clinician reviews are more usually reserved for clinician-reported measures, or for particular circumstances in which testing with patients in the target population is particularly problematic (Wild ''et al.'' 2005). Some companies use the term "linguistic validation" to refer to the entire process of translating PRO measurements as described in the "Principles of Good Practice" (Wild et al. 2005),Wild, Grove, Martin, Eremenco, McElroy, Verjee-Lorenz, Erikson
"Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO)Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation"
'' Value In Health'' Vol 8(2) 2005 and in the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force report (Wild et al. 2009),Wild, Eremenco, Mear, Martin, Houchin, Gawlicki, Hareendran, Wiklund, Chong, von Maltzahn, Cohen, Molsen
Multinational Trials—Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report
'' Value in Health'' Vol 12(4) 2009 even if the process does not include patient interviews or a clinician review. The recommended

methodology In its most common sense, methodology is the study of research methods. However, the term can also refer to the methods themselves or to the philosophical discussion of associated background assumptions. A method is a structured procedure for bri ...

utilizes double, independently created translations into the target language, which are then combined into a "reconciled version" which uses the best of both translations. The reconciled version, or harmonization, is then back-translated by two separate "blinded" translators who have no previous knowledge of the original questionnaire. The back-translations are used as a window into the translated version, so that the project manager can assess whether the translated version accurately assesses the concepts measured by the source questionnaire. This stage is described as the back-translation review. Ideally, it would be followed by patient interviews or a clinician review. PROs should not be confused with PCOs (patient-centered outcomes). PCOs are the use of a questionnaire covering matters and concerns specific to a particular patient. A comprehensive linguistic-validation process, including cognitive debriefing, is vital to demonstrate content validity in translations for use in a U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) submission.

References

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External links

U.S. Food and Drug Administration

The International Society for Pharmoeconomics and Outcomes Research
Clinical research Translation

Methodology

See also

References

External links