Translation for Clinical Trials is highly technical, and requires a much more thorough and technical approach than translation for other industries or materials. Rather than a general translation, outcome assessment materials must undergo a process known as Linguistic Validation. This is necessary not only to comply with FDA regulations, but to ensure that patients are able to understand and relate to materials. Without this, outcome reporting runs the risk of being unreliable.
What is Linguistic Validation?
Incorporating the ideas of both localization and translation services, Linguistic Validation is the process of culturally and linguistically adapting clinical outcome assessment materials for target trial participants.
The validation process involves a series of translations, as well as tests, in order to confirm that it has been properly adapted for the target culture. It also helps researches ensure that the translated content is true to the source material, and that it is understood in the same manner across different language groups if applicable. If it fails to be understood in the same manner across participants in the entire study, responses run the risk of being misleading when applied to the trial.
This process is necessary to satisfy FDA regulations concerning content validity for clinical trial translations.
Validating Patient Questionnaires
The use of Quality of Life (QoL) questionnaires is becoming a standard practice in the majority of clinical trials. With the expansion of clinical research into new emerging regions, questionnaires must commonly undergo translation into multiple languages.
Given the importance of such instruments, implementing cultural and linguistic adaptation strategies, beyond simple translation, is absolutely essential. For one thing, daily activities that may be common in one culture may not play the same role in other cultures. Linguists must therefore ensure that the translated versions effectively measure quality of life in the corresponding culture.
This means implementing rigorous linguistic validation methods.
There are endless examples of various issues related to the translation of patient questionnaires. A specific question assessing pain and physical limitations may need several rounds of review if it is to be made relevant for a particular target patient population.
Word choice is also highly important, as not all terms translate directly into different languages, not all terms are used the same way in different languages, and not all participants will have the educational background to understand all terms.
As such, part of linguistic validation could be to determine whether the equivalent word in your target language for abdomen or stomach area is most appropriate for patients participating in the trial.
Sample Linguistic Validation Case: Do You Experience Pain Or Difficulty When Going About Household Chores Such As Mowing the Lawn?
Say you were preparing quality of life questionnaires that included the above question. What would you need to do in order to ensure it was adapted for your target market?
Perform Cultural Adaptation
In the above question directed at whether a patient has encountered any pain or difficulty going about their household chores such as mowing the lawn, you would need to ensure that the question applies to the target patient population.
Although this question may make perfect sense in a region who’s climate allows for the possession and maintenance of a lawn, it may be completely irrelevant for others.
The quality and accuracy of a patient questionnaire is largely dependent on the cultural relevance of the content. So, while it is common for people in some countries to perform lawn maintenance, in other countries there may be little need for since most homes may not have a lawn due to climate differences.
Evaluation of questionnaires will also require an understanding of cultural differences in regard to the perception of pain, as it may very well vary among cultures.
That’s not all you need to be aware of however…
Take into Account Word Choice
Word choice is also important when adapting patient materials, as there may not be a direct translation. In the example above, you could run into the issue of the word “chore” not having an equivalent in some languages.
Depending on what your clinical trial is targeting, you may also run into issues with certain diseases not translating over (or even conceptually existing), or cultural barriers in terms of scientific and health related education.
Each question, therefore, requires the expertise of both linguists and medical staff who are fluent in the target language, and who have a thorough understanding of the patients’ culture.
Undergo Cognitive Debriefing
Finally, the translated version of the questionnaire must be tested on actual patients. This process, known as cognitive debriefing, is to ensure accuracy and usability of the patient questionnaire prior to its use in a study.
The questionnaire will be given to patients (who fit the target demographic of the region in question), who will complete it and respond to questions at the end related to how they understood the meanings of certain words.
After this has been completed, necessary adjustments can be made to the final translation, in order to ensure it will be clearly understood by trial participants.
The obvious result of the above example, is that the process of linguistic validation is considerably more time consuming than translation of other types of content. Nevertheless, if these instruments are to be effective and comparable to those from other relevant studies, such a process is crucial.
The Step by Step Linguistic Validation Process:
1. Forward Translation: The first step in linguistic validation, called forward translation, requires a team of translators to independently translate the text into the target language. Forward translations should always be performed by experienced professional translators who are native speakers and have a background in the field.
2. Reconciliation: Next, translators must compare the forward translations and reconcile them into a single version. The reconciled version should be conceptually equivalent to the source document, but take into account word choice and cultural nuances. This element is critical as a simple direct translation may change the intended meaning of the original content.
3. Back Translation: The reconciled version is then translated back into the original source language to ensure that the meaning has not been “lost in translation.” The back translation should be performed independently by a separate team of at least two translators who have not seen the original source document, and who can provide unbiased feedback.
4. Document Review: Upon completion, the back translation is then reviewed and comparison between the original source document and the harmonized translated version is conducted to determine the accuracy and linguistic validity of the translation.
5. Cognitive Debriefing Interviews: Cognitive debriefing interviews are used to test translated documents for accuracy and consistency. It involves completion of translated PROs by individuals fitting the demographics of your target patients, and review of their understanding and comprehension of the texts.
4. Final Review: A final version of the translation for use in the trial is then constructed based on findings from the cognitive debriefing interviews.
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