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Clinical Outcome Assessments (COAs), regardless of their type (Patient Reported Outcomes – PROs, Observer Reported Outcomes – ObsROs, Clinician Reported Outcomes – ClinROs, or Performance Outcomes – PerfOs) have placed patients in the center of clinical trials. How a patient feels, functions, or survives is a differentiating factor, influencing the progress of clinical trials and the development of new treatments. To make this feasible and avoid COA source revisions during the COA localization process, that would result in increased costs and timelines, there are a few points that should not be missed during COA development:
1. Specify the target population
Will your instruments be administered to adults only? If not, maybe it’s worth taking into consideration aspects such as the age or any other underlying condition of the participants. For instance, apart from the specific words that should be simpler for children, multiple languages need to inflect the same verbs differently, depending on the syntax and context. Another example is the fact that participants with vision issues will need a bigger font and a clearer format that doesn’t cause them trouble when reading the questions or filling in their responses. So, precisely defining your target population will help you take into consideration parameters that are relevant to the study in question and be prepared for a “final” COA version since the early development stages.
2. Draft clear questions for the laypeople
Another point to consider is that the target population for most clinical trials comes from different backgrounds and levels of education. So, making sure that the content of your instrument can be understood by everyone is of crucial importance. Besides, under stressful conditions, even people with a very high educational level can get confused with complex concepts, regardless of whether they are familiar with them or not. Thus, reducing highly technical terminology should be considered as an option to avoid COA source revisions at a later point in the process. And in cases where the use of such jargon cannot be avoided, it should be explained as thoroughly as possible.
3. Consider the target languages, countries, and the overall translatability of the content
Additionally, if the clinical trial is going to be performed just in English-speaking countries, things might be simpler, but the local sites and target languages of the clinical trial are rather important when drafting and translating COAs. For instance, stem phrases that need to be repeated to form a full question, may work perfectly well in English, but not so much in other languages, where the word order rarely matches the English one.
Example of a stem question:
In the past 7 days,…
- have you been feeling well?
- have you been feeling bad?
This is why COAs should undergo a translatability assessment before being sent for translation. What is more, by performing a translatability assessment, redesigning the COA, or making edits can be avoided at early stages, which minimizes the risk of losing precious time and raising the cost.
4. Be mindful of cultural considerations
Cultural relevance is another important factor, just like the translatability assessment mentioned above. What might be appropriate in one culture might not be in another. A simple example is the participant’s diet. Depending on one’s cultural background, eating specific types of food (e.g., meat) might not apply. Another similar example is the use of cutlery while eating. In Asian countries, having a question referring to the use of a fork and a knife might need to be replaced by a question mentioning the use of chopsticks.
On another level, sensitive topics or taboos in one culture might not be an issue in another. So, it is always a good idea to consider the cultural appropriateness of the instrument for the target audience as early as possible to prevent several edits later. This can be achieved by establishing clear and robust communication channels between the COA developers and the translation team from the early stages of the process.
5. Clarify concepts and nuances
In addition to the above, a well-defined list of concepts precisely explaining the intended context and purpose of use of each item should be readily available from the initial stages of localization to maintain clarity and avoid confusion. A well-structured list of concepts, also providing alternatives and guidance, can help the localization process. This way, surprises that would cause the repetition of one or several steps and possibly exceed the initial project budget may be avoided.
6. Design the COA having the linguistic validation process in mind
Finally, it should be noted that linguistic validation is a critical process for global COA development. Having a partner such as Commit Global, who could support you and provide guidance, will help you validate the translations on a linguistic level, perform cognitive debriefing interviews and ensure that the translated COA instruments are accurate, reliable, and culturally appropriate for the target populations in clinical trials, thus minimizing the risk of significant COA source revisions along the way.