Despite the clear need for local adaptation, many clinical questionnaires maintain the same presentation (layout, visual design, structure) across all target languages and scripts.

This article looks at why this happens and why it is a problem.

1.       Regulatory and Validation Constraints

Clinical Outcome Assessments (COAs) usually go through rigorous psychometric validation in their source language. Sponsors and regulatory bodies, such as FDA or EMA, want to ensure that translations do not unintentionally alter the measurement properties.

There is a fear that altering the visual design, such as the layout, scale orientation and formatting, could introduce variability that might affect cross-cultural comparability or the validity of pooled data.

The result is that sponsors often “lock” the format, instruction translation teams and eCOA developers to “mirror the source exactly”, not just the conceptual equivalence, but also the layout, front, typefaces and positioning.

2.       Cost and Time Efficiency

Reworking a questionnaire’s design for multiple scripts introduces additional time, resource and production overheads.

Therefore, teams often take a “lift and shift” approach, translating the text while dropping it into the same source-language template, regardless of script or typographic norms.

This means that design localisation is sacrificed in favour of quicker delivery and reduced cost.

3.       Misunderstanding Localisation versus Translation

Some stakeholders equate linguistic translation with full localisation. They are not the same thing. They may not realise that script- and culture-specific visual formatting, such a Right-to-Left adaptation, is part of making the tool fit-for-purpose in a new context.

The result is that there is an assumption that accurate translation alone suffices for usability, ignoring visual or cognitive factors tied to scripts.

4.       Legacy Practices in Clinical Research

Historically, COAs were distributed as paper-based forms, where reformatting was discouraged to prevent transcription or scoring errors.

Even as clinical trials move to eCOAs or digital forms, many developers still default to legacy templates created for Western/Latin scripts.

Accordingly, the inertia of old habits persists, keeping source templates as rigid “master” design.

UX Guidelines for Cross-Script Adaptation

To mitigate the cognitive burden, here are best practices for adapting questionnaires across scripts:

1.       Respect Script-Specific Layout Norms

For RTL scripts (Arabic, Hebrew):

·       Mirror layouts entirely, such as questions right-aligned, answer scales flipped to RTL.

·       Adjust table and checkbox orientation to flow naturally right-to-left.

For dense or blocky scripts like Chinese, Korean, Tamil:

·       Increase line spacing (leading) and margin balance to prevent visual crowding.

·       Consider vertical layouts where culturally appropriate, such as Japanese formal documents.

2.       Localise Scale Presentation

·       Likert scales should ideally need to shift from horizontal to vertical depending on cultural conventions and how respondents are accustomed to visual hierarchies.

·       Numeric scales may need flipped endpoints, e.g. 1-5 scales where the “1” is placed on the right for RTL scripts.

3.       Typography Matters

·       Use fonts optimised for each script, such as Noto Sans for Arabic or Source Han Sans for Chinese.

·       Do not apply Western bolding or italicisation without confirming it carries the same emphasis in the target script.

4.       Cultural Sensitivity in Visual Grouping

·       Readers from collectivist cultures may process groups, e.g. grouped questions or clustered answers) differently from those in individualist cultures.

·       In some Asian or Middle Eastern context, respondents may prefer clearer sectioning, e.g. boxes, shaded areas, to delineate instructions from response fields.

5.       Usability Testing

·       Conduct cognitive debriefing and usability testing with target population not just for text clarity but also for visual comfort and processing fluency.

Summary of the core tensions:

·       Sponsors prioritise content equivalence for regulatory and scientific rigour, so they resist layout changes.

·       Yet scripts are not neutral. They carry cognitive, visual and cultural processing implications. When layouts ignore script characteristics, this leads to higher cognitive burden, potential misinterpretation and data quality risks.

Thank you for reading,

Mark Gibson

Leeds, United Kingdom, August 2025