When Clinical Outcome Assessment (COA) translation has completed linguistic validation and the translation is correct, it means these stages have occurred:  

• Terminology has been agreed upon 
• Required reviews are completed 
• It’s gone through cognitive debriefing and the linguistic validation process
• Final Certificate of Translation has been produced 

Importantly, the version the patient most frequently interacts with these days is an electronic version of that translation. eCOA migration and eCOA implementation sit between the approved file and the patient-facing screen. The migration process introduces another opportunity for discrepancies to arise between the approved COA instrument translation and the version ultimately presented to the respondent. These are seven ways eCOA migration could create discrepancies when executed incorrectly.  

#1 eCOA Migration Mistake: Text is Truncated

Languages expand differently. Content that fits comfortably within an English interface may become considerably longer in another language. If the interface doesn’t accommodate this length change, translated text may be cut off, overlap other elements, or require unexpected scrolling. This can influence patient answers.

#2 eCOA Migration Mistake: Line Breaks Change How the Item Reads

Line breaks may appear cosmetic, but they can alter comprehension. A poorly placed line break during eCOA migration can separate a qualifier from the phrase it modifies. This kind of error could also change how an instruction is visually interpreted. The words are still correct, but their presentation, and thus how the patient answers, are compromised.

#3 eCOA Migration Mistake: Response Options are Displayed Incorrectly

Response scales may be affected when:

• Options appear in the wrong order
• Labels become disconnected from buttons
• The visual relationship between responses changes

A correct COA translation cannot compensate for an incorrectly implemented response structure. It also can’t ameliorate copyright infringement and its consequences, but this is a story for another time.

#4 eCOA Migration Mistake: Meaningful Formatting Disappears

Bold, capitalization, spacing, or indentation can all impact text meaning significantly from language to language. These effects may distinguish instructions, emphasize recall periods, or guide the respondent through an assessment. If these textual distinctions disappear during eCOA migration, all the correct words may still be present. However, the patient's experience of reading (and responding) will change.

#5 eCOA Migration Mistake: The Platform Doesn’t Behave Naturally in the Language

One example is right-to-left languages. Appropriate eCOA migration involves more than right-aligning translated text. Navigation, response scales, numbers, and mixed-direction content must all behave naturally. Other languages may introduce challenges around differences in:

• Character sets
• Fonts
• Text expansion

#6 eCOA Migration Mistake: A Late Change Creates Multiple Versions of the Truth

If a linguistic change is approved after eCOA migration has started, it can create discrepancies. The approved file may be updated, but perhaps the electronic build may not be. Screenshots may be generated without the change, or perhaps not every stakeholder works from the same version. The risk is that the correct translation exists in one location, while an outdated version is used elsewhere.

#7 eCOA Migration Mistake: Correct Content is Implemented in the Wrong Place

A COA translation may be correct, but mapped to the wrong item, instruction, or response option. This mistake can be particularly difficult to detect when implementing large volumes of multilingual content. The patient sees the screen but does not interact with the approved translation file, linguistic validation report, or translation certificate. Most likely, the patient interacts with the App or Desktop version. This means quality cannot stop at linguistic approval. It must continue through migration, testing, and deployment. This is precisely why screenshot review is such an important part of eCOA localization. It provides one of the final opportunities to confirm that the patient-facing version still reflects what was originally approved. The challenge is what happens when that final verification step starts finding ‘too many’ problems.

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References

Mowlem FD, Elash CA, Dumais KM, et al. Best Practices for the Electronic Implementation and Migration of Patient-Reported Outcome Measures. Value in Health. 2024;27(1):79–94. doi:10.1016/j.jval.2023.10.007.  

O'Donohoe P, Reasner DS, Kovacs SM, et al. Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task Force. Value in Health. 2023;26(5):623–633.  

Romero H, DeBonis D, O'Donohoe P, et al. Recommendations for the Electronic Migration and Implementation of Clinician-Reported Outcome Assessments in Clinical Trials. Value in Health. 2022;25(7):1090–1098.