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 dim ...

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 A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PR ...

(PRO) measures.

Methodology

Most usually, linguistic validation refers to a process whereby translated text is actively 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 health care ...

in the target population and target language group through cognitive debriefing interviews. For example, if the PRO instrument is intended to measure the

symptoms Signs and symptoms are the observed or detectable signs, and experienced symptoms of an illness, injury, or condition. A sign for example may be a higher or lower temperature than normal, raised or lowered blood pressure or an abnormality showi ...

diabetes Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level ( hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ...

in a trial in

Denmark ) , song = ( en, "King Christian stood by the lofty mast") , song_type = National and royal anthem , image_map = EU-Denmark.svg , map_caption = , subdivision_type = Sovereign state , subdivision_name = Kingdom of Denmark , establish ...

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

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

. This interview exercise ensures that items are appropriate for use in the target population, 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 what they think each item means in their own words. The results of this

cognitive debriefing Cognition refers to "the mental action or process of acquiring knowledge and understanding through thought, experience, and the senses". It encompasses all aspects of intellectual functions and processes such as: perception, attention, thought, ...

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 clearly expressed 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 in 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 word, or multi-wo ...

and

phrases In syntax and grammar, a phrase is 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 happy". Phrases can consi ...

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. ...

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 for the translation of PRO measures 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 ''Value in Health'' is a medical journal that covers original research and health policy articles in the field of health economics and outcomes research. The journal is published, on the behalf of ISPOR, by Elsevier Elsevier () is a Dutch acad ...

'' Vol 8(2) 2005 and 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 ''Value in Health'' is a medical journal that covers original research and health policy articles in the field of health economics and outcomes research. The journal is published, on the behalf of ISPOR, by Elsevier Elsevier () is a Dutch acad ...

'' Vol 12(4) 2009 even if this 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 br ...

utilises double, independently created translations into the target language, which are then combined into a 'reconciled version' which uses the best of both forward translations. The reconciled version, or harmonization, is then back translated (

back translation Translation is the communication of the meaning of a source-language text by means of an equivalent target-language text. The English language draws a terminological distinction (which does not exist in every language) between ''transla ...

) by two individual 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. Please note however, PROs should not be confused with PCOs, or patient-centered outcomes. PCOs implies the use of a questionnaire covering issues and concerns that are specific to a 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 federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA) submission.

References

External links

U.S. Food and Drug AdministrationThe International Society for Pharmoeconomics and Outcomes Research
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