NN Translations has supported the Linguistic Validation of Patient-Reported Outcome (PRO) measures across 15 languages and a range of therapeutic areas and target populations, including projects involving Huntington's disease, Crohn's disease, Sjögren's disease, systemic sclerosis and rheumatoid arthritis.
Working as a specialist Linguistic Validation partner within multilingual clinical studies, our teams have supported different stages of the LV process, including translation availability and Linguistic Validation gap assessment, review of existing translations and validation history, forward translation, reconciliation, back translation and review, Cognitive Debriefing, disease-specific participant recruitment, linguistic analysis and finalisation of the translated instrument.
Where existing translations were available, we assessed the materials and available validation information to help determine whether an existing version could be used, whether further Linguistic Validation or adaptation was required, or whether a new translation needed to be developed. This helped establish the appropriate pathway for the assigned language and country rather than automatically initiating a new translation.
This case study brings together selected anonymised examples to illustrate how we apply a project-specific Linguistic Validation approach, adapting the methodology to the instrument, existing translations, target population and individual project requirements.
The Challenge
Linguistic Validation of PRO measures requires more than producing an accurate translation. The appropriate pathway may differ considerably depending on what translations already exist, how they were previously validated, the intended country and population, and the methodology required for the instrument.
Across the selected projects, our work required us to:
Assess existing translations and available Linguistic Validation history before determining the required pathway
Identify translation and validation gaps for the assigned languages and countries
Determine whether existing content could be used or whether adaptation, additional validation activities or new Linguistic Validation were required
Preserve conceptual equivalence throughout the assigned Linguistic Validation stages
Coordinate independent linguistic stages according to the required methodology
Work with native-speaking Linguistic Validation Consultants and specialised translators
Coordinate native-speaking Linguistic Validation Consultants responsible for recruiting participants according to disease-specific and project-specific eligibility criteria where Cognitive Debriefing is required
Evaluate whether translated items, instructions and response options were understood as intended
Review the LVCs' analysis of participant feedback, including the distinction between individual participant preferences and findings indicating a genuine linguistic, cultural or conceptual issue
Address population-specific considerations emerging during recruitment and Cognitive Debriefing
Maintain clear documentation and traceability of linguistic decisions and revisions
One such consideration arose during a Huntington's disease project. During recruitment, it became apparent that participants' ability to engage with the questionnaire independently differed according to the stage of the condition. Participants with mild to moderate disease were able to engage with the questionnaire independently, while those with more advanced disease required caregiver support.
We raised this with the client so that the participant criteria and appropriate respondent approach could be considered before Cognitive Debriefing proceeded, rather than applying the same approach across participants at different stages of the condition.
Our Approach
At NN Translations, the Linguistic Validation approach is adapted to the instrument, existing translations, target population, language and country, available reference materials, applicable project methodology and instrument developer/copyright holder requirements rather than applying the same workflow to every instrument.
Translation Availability and Linguistic Validation Gap Assessment
Where existing translations were available, we reviewed the assigned language and country requirements against the materials and available validation information provided for the project.
The assessment considered the existing language version, intended country of use, available Linguistic Validation history and applicable project requirements to identify what further work, if any, was needed.
Depending on the findings, the resulting pathway could involve use of an existing validated translation, country-specific adaptation, completion of additional Linguistic Validation activities, or development and Linguistic Validation of a new translation.
This allowed subsequent work to be based on the actual gaps identified for each assigned version, rather than applying the same Linguistic Validation workflow unnecessarily across all languages.
Concept-Focused Translation
Throughout the assigned translation and review stages, the focus was on conceptual rather than literal equivalence.
Source content, concept definitions and available reference materials were considered when evaluating translation choices. The objective was to preserve the intended meaning of the source instrument while ensuring that the target language wording remained natural, culturally appropriate and understandable to the intended target population.
Independent Translation and Linguistic Review
Depending on the methodology and our assigned scope, the Linguistic Validation process included stages such as two independent forward translations, reconciliation, back translation, back translation review and subsequent linguistic review.
Differences between proposed translations were evaluated against the intended source concepts rather than resolved solely according to linguistic or stylistic preference.
Translation decisions and relevant queries were documented throughout the assigned stages to maintain traceability within the wider Linguistic Validation programme.
Disease-Specific Participant Recruitment
Where Cognitive Debriefing was required, participant recruitment was planned according to the target population and eligibility criteria established for each project.
Our native-speaking Linguistic Validation Consultants recruited participants locally, using appropriate channels and networks, including patient organisations where applicable. NN Translations coordinated the recruitment process and reviewed progress against the agreed participant criteria and project requirements.
The Huntington's disease assignment demonstrated why recruitment cannot always be treated as a purely administrative stage. During recruitment, the LVC identified differences in participants' ability to interact with the questionnaire independently depending on the stage of the condition, raising an important consideration regarding respondent suitability and potential caregiver involvement.
Rather than proceeding without clarification, the issue was escalated to NN Translations and communicated to the client, allowing the appropriate respondent approach to be considered before the Cognitive Debriefing interviews proceeded.
Cognitive Debriefing with the Target Population
Native-speaking Linguistic Validation Consultants conducted structured Cognitive Debriefing interviews with eligible participants to evaluate whether the translated instrument was understood and interpreted as intended.
Depending on the instrument and methodology, participants were asked about their understanding of individual items, instructions, response options and relevant terminology and could be asked to explain content in their own words.
This provided an opportunity to identify potential comprehension issues that may not have been apparent during the preceding linguistic review stages.
Analysis of Participant Feedback
Participant feedback did not automatically lead to translation changes.
Following the interviews, the Linguistic Validation Consultant analysed the findings against the intended source concepts, previous linguistic decisions and feedback across the participant group.
Individual wording preferences were distinguished from findings indicating a genuine comprehension, linguistic or cultural issue. Where a potential issue was identified, participants' understanding of the relevant wording was probed further, the translation was reassessed against the intended concept and, where appropriate, a revision was proposed according to the applicable project methodology.
NN Translations reviewed the LVC analysis and resulting linguistic decisions as part of the project review and quality assurance process.
Finalisation and Documentation
Following completion of the assigned Linguistic Validation activities, findings, proposed revisions and final linguistic decisions were documented according to the project requirements.
The final deliverables included the Linguistic Validation documentation and Certificate of Linguistic Validation, providing traceability of the completed validation process.
The Result
Across these assignments, NN Translations successfully supported Linguistic Validation of PRO measures for different therapeutic areas and disease-specific target populations, adapting the approach to the requirements of each instrument and project.
The projects resulted in:
Successful completion of assigned Linguistic Validation stages across multiple PRO projects
Translation availability and Linguistic Validation gaps assessed to determine the appropriate pathway for assigned language versions
Existing translations considered for continued use, adaptation or additional validation, where applicable
Disease-specific participant recruitment according to project-specific eligibility criteria
Cognitive Debriefing conducted with representatives of the intended target populations
Identification and escalation of population-specific considerations affecting respondent suitability and caregiver involvement
Structured evaluation of participant understanding against the intended source concepts
Translation revisions made where supported by linguistic and conceptual analysis, while unnecessary changes were avoided
Clear documentation of findings, revisions and linguistic decisions
Completion of assigned deliverables within the required project scope and timelines
By combining translation and Linguistic Validation gap assessment, concept-focused translation, target population recruitment and Cognitive Debriefing, NN Translations supported both the linguistic and operational requirements of these PRO projects.
The Huntington's disease assignment also demonstrated the importance of looking beyond predefined recruitment criteria. When characteristics of the target population affect how a PRO measure can be completed, identifying and communicating these considerations early helps ensure that the appropriate respondent approach is clarified before Cognitive Debriefing proceeds.