The goal of Linguistic Validation of Patient Reported Outcomes (PROs) is to achieve linguistic and conceptual equivalence so that data gathered from participants in multinational studies may be pooled across languages and cultures.
A critical component of the linguistic validation process is the creation of a list of concept elaborations during the project preparation stage. The objectives of concept elaborations are to define the instrument's items (questions and/or statements) instructions and response options, highlight potential challenges in translation and suggest solutions wherever possible.
Sample Concept Elaboration
- Item - I am bothered by headaches
- Definition - This item seeks to assess if the respondent has had headaches that are disturbing.
- Potential Translation Challenge -"Bothered" is understood to only mean having in some cultures. The intent of it here is to convey both having the headaches and being disturbed by them.
- Acceptable Translation Alternative -I have headaches that are disturbing
- Unacceptable Translation Alternative -I have headaches
Consider the following items from the same instrument:
- I am jumpy
- I am jittery
- I am on edge
- I am agitated
Least Severe Anxiety x_________x__________x__________x Most Severe Anxiety
The developer's input for synonymous terminology is essential to guarantee the intent of each item is defined accurately.
Now, imagine a partnership between developers and translation providers that begins at the time the source items are being created to ensure they have the maximum potential for validity across languages and cultures. The translation provider would perform a translatability review and advise the developer on alternatives for colloquialisms, synonyms, passive language and grammatical structures, which may all pose translation difficulties down the road. A translatability review in conjunction with source item creation would save the study sponsor time and money when both are of the essence.
These partnerships do exist in the industry today; however, additional awareness is needed to promote and nurture them so that they become an integral component of the Linguistic Validation process.
For more on this topic, take a look at the following articles we've written:
- The ABCs of PROs
- Back translations - useful or waste of time?
- Linguistic validation for PRO and QoL instruments
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