Localized cognitive debriefing of PROs

Cognitive debriefing is a step within the linguistic validation process to validate a questionnaire called a patient-reported outcome (PRO) – PROs are used in clinical research, such as trials or studies. This step is usually carried out via face-to-face interviews with participants in the target country. The aim of the interview is to evaluate (the “debrief” part) the translated questionnaire, ensuring that everything is fully understood (the “cognitive” element) in the target language. It’s an opportunity to make sure the patient voice is represented in the translated version.

The cognitive debriefing interview is carried out by a trained interviewer with a selection of native speakers of the target language being tested. The PRO being validated may focus on a certain condition, such as migraine or diabetes, therefore people with those conditions will usually be recruited as interviewees. 

“It’s an opportunity to make sure the patient voice is represented in the translated version.”

The interview is conducted to uncover elements of the questionnaire which may be difficult to understand, to ensure it matches the source meaning, or to remove any culturally inappropriate or taboo wording.The focus is on wording the questionnaire in the most appropriate way for the target culture. Some PROs ask about certain symptoms or illnesses, which can result in questions touching on very personal information – this means it’s especially important for the interviewer to follow these steps: 

1. Make sure the participant feels comfortable

Cognitive interviews are carried out in person or over the phone in a one-to-one session with participants. This allows them to freely discuss terms they don’t quite understand and to explore their interpretation of terms to ensure the translated questionnaire is still reflecting the original meaning. To do this, the PRO question is read out to the participant who then has to either rephrase or give examples to demonstrate how they’ve understood it. 

It’s natural that participants may sometimes feel embarrassment, shock, sadness or upset as the questions can touch on sensitive topics. It’s therefore important to support them throughout the interview, to help them feel relaxed and in a safe environment where they can respond honestly.

2. Read the non-verbal cues

Body language and intonation are as important as verbal language. If the interview is being conducted via phone, it’s especially important that the interviewer pays attention to the participant’s intonation. Elements such as pauses, sighs and laughs can all help indicate that something might not be right in the current target language version and the questionnaire may require rewording to achieve true equivalence of source meaning. If it’s being conducted in person or via video chat, the interviewer will also take the opportunity to observe the participant’s body language, to pick up on any non-verbal cues. 

3. Ask open-ended questions

It’s much better to ask open-ended questions than to go with closed ones that could be answered with just a “yes” or “no”. The interviewer will probe further to establish why a particular question doesn’t make sense, for example asking the participant how they could rephrase it in another way – this allows the interviewer to gain further insight into how the participant has understood the question.

4. Don’t let it get too personal

5. Find the balance

Some participants might want to spill all the beans, and some might be really shy. The interview may be a rare chance for someone to talk about their condition outside of a clinical environment. The interviewer needs to find the balance between allowing the participant to express themselves openly and respecting their boundaries. Being respectful and reminding the participant that this is a linguistic exercise rather than a direct question usually helps to put them at ease.

6. Check cultural issues

Directly asking participants questions also helps to iron out cultural issues in the PROs. It may be flagged up that the equivalent use of the word “dinner” or “lunch” doesn’t quite match the source version of the idea. Dinner time may imply 17:00 in the UK, but be considered as 20:00 in Chile. Or it could be that culturally an ideal or certain word equivalence doesn’t exist in the target language. Terms such as “tired” and “fatigue”, which are separate concepts in English, may be considered conceptually to be exact synonyms in other languages, for example. 

Key areas to check for cultural equivalence include:

• • • sports
    • hobbies
    • daily life activities
    • food
    • colors
    • emotion and mood terminology
    • tone of language
    • taboos
    • sensitive topics

7. Be compliant!

Participants entrust the interviewer with their data and personal information. The interviewer must ensure they get consent from the participant that is compliant with any ethics or data-handling procedures in that particular country. Whether the study requires full ethical approval from a local ethics committee or institutional review board, for those in the EU, any data from the debriefing must also comply with GDPR to avoid nasty surprises further down the line. 

Patient voices should be heard throughout research, including in translated versions of PROs. Feedback and testing via cognitive debriefing is one way to achieve this. This post covers just a snapshot of what should be covered during the interview phase. The full linguistic validation process continues on with further assessment from professionals such as PRO developers, cognitive debriefing analysts, and linguistic review to reach the perfect translated version of the source PRO.

By Anna Richards