Translation and Linguistic Validation of Patient Questionnaires
Sometimes, translation is not enough.
A well translated text has the same meaning as the original. However, with patient questionnaires used in global clinical trials,
one needs more than equivalence of meaning, one needs equivalence of construct value for each culture.
For example, if a Quality of Life (QoL) item asks about the subject's ability to perform typical activities and uses "playing golf" as an example,
simple translation may not be adequate for countries where playing golf is not considered typical.
A different activity that has equivalent construct value may need to be identified for each target language and region.
In order to be used as valid research instruments in international clinical trials, patient questionnaires must be culturally
adapted and the translations need to be linguistically validated.
An instrument that did not undergo a linguistic validation process may threaten the validity of research data and the
safe aggregation of global data sets.
Linguistic Validation Overview
The need to translate and adapt patient questionnaires for use in multiple languages and geographical regions has grown rapidly.
This is due, in part, to the global scope of many clinical trials,
as well as to the new FDA and EMEA guidelines for using Patient Reported Outcome (PRO) endpoints from international
clinical trials to support label claims. Specifically, in their 2009 Guidance, the
FDA recommends
that sponsors provide evidence that content validity and other measurement properties are adequately similar between all versions used in the clinical trial.
Language Scientific (LS) offers fully compliant Linguistic Validation and Cultural Adaptation services (including Cognitive Debriefing)
to ensure item equivalence between an instrument's original source text and translated versions.
This can be critical to ensure that content validity is not affected by translation, and that data across sites can be pooled.
Linguistic Validation and Cognitive Debriefing Process
Language Scientific employs a rigorous Linguistic Validation and Cognitive Debriefing process that follows the
International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommended
methodology.
First, the questionnaire or measure undergoes a Translatability Review to discover and assess
any potential concept or wording issues that may arise during translation and adaptation for target locales.
Based on the results of the Translatability Review and customer consultations,
we draft detailed instructions to the linguistic teams with explanations of key constructs and guidelines
on how to resolve specific problems or ambiguities we discovered.
We also begin recruiting teams for each target country and work with the customer to obtain copyright permissions for translation.
Next, we perform two forward translations using independent, certified translators.
During reconciliation, the Project Manager compares the two translations and compiles them into a unified translation.
This compiled translation goes through proofing and formatting.
Following reconciliation of the two independent forward translations, a literal back translation is done by a third translator
with no previous knowledge of the original instrument.
This back translation helps the Project Manager perform Translation Review to assess translation accuracy and to
identify potential discrepancies in content value.
At this step, a Corrected Translation is generated. If the instrument is disease- or condition-specific,
the Corrected Translation is reviewed by a clinician practicing in the target country in the relevant field.
This clinician verifies that references to medical conditions, symptoms and disorders are expressed using terms the clinician uses with local patients.
In the Harmonization stage, any content value variances among the translations in all the target languages are identified and resolved.
This harmonization provides uniformity across all language translations.
Next, Cognitive Debriefing is done to ensure that the validated instrument is both culturally acceptable and contextually relevant to target populations.
Language Scientific uses in-country professionals experienced in interviewing techniques such as psychologists, psychiatrists, or social workers.
These investigators conduct cognitive debriefing interviews with 5–8 subjects that reflect the potential instrument respondent population.
After interviews are complete, an interview report is generated.
Finally, the Project Manager reviews the Cognitive Debriefing report and finalizes the translation.
A final round of proofreading occurs, and the databases are updated.
A final report detailing Language Scientific's Linguistic Validation process and the final translations are sent to the customer.
Our People
Our ASKnetwork™ of project managers, certified translators, in-country investigators, clinicians, psychologists, linguists and other professionals
residing in 120 countries, combined with our ISO 9001:2008 and EN 15038:2006 certified processes,
allows us to confidently meet our customer's cost and deadline requirements.
Our clinical team includes specialists in numerous therapeutic fields, including:
- Cardiology
- Central Nervous System (CNS)
- Dermatology
- Endocrinology
- Gastroenterology
- Gynecology
- Hematology
- Nephrology
- Neurology
- Ophthalmology
- Oncology
- Pain/Inflammation
- Psychology
- Psychiatry (including depression, schizophrenia, anxiety)
- Pulmonology
- Rheumatology
- Urology
- Women's Health
Linguistic Validation Benefits
Language Scientific's Linguistic Validation services verify that translations of all items are interpreted in the same
way across target populations and regions and have the same content validity.
The customer can then be sure that measurement properties of the items will be the same across different language
versions of the instrument, that data can be validly pooled across international sites, and that the process will meet FDA and EMEA guidelines.
How to Request a Proposal or Get More Information About Our Linguistic Validation Services
To discuss your organization's language service requirements, and to learn more about our Linguistic Validation and Cognitive Debriefing services,
call us at 800-240-0246, or e-mail us
at: info@languagescientific.com.
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