7 ways to master linguistic cognitive debriefing interviews of Patient Reported Outcomes
Considering the terminology - Photo by Tachina Lee on Unsplash

7 ways to master linguistic cognitive debriefing interviews of Patient Reported Outcomes

Cognitive interviews are a step within the linguistic validation process to validate a questionnaire called a Patient Reported Outcome (PRO) measure to be used in clinical research, such as clinical trials or studies.

Cognitive debriefing within linguistic validation is usually carried out during face to face interviews with participants in the target country.

The aim of the interview is to evaluate (the “debrief”) the translated content of the questionnaire, ensuring that everything is fully understood (the “cognitive” element) in the target language. It’s an opportunity to hear the patient voice in the translated version.

The cognitive debriefing interview is done between a trained interviewer and a selection of native speakers of the target language being tested. The questionnaire may be on a certain condition, such as melanoma, diabetes or Charcot-Marie Tooth disease, and so people with those conditions will usually be recruited as interviewees.

“It’s an opportunity to hear the patient voice in the translated version.”

The interview is done to uncover elements of the questionnaire which may be difficult to understand, or to ensure it matches the source intention, 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 will ask about certain symptoms or illnesses with the result that some questions can be very personal so it’s important to follow these approaches below:

1.      Make the participant feel comfortable throughout the interview

Cognitive interviews are carried out face-to-face or over a phone in a one-to-one session. This allows participants to discuss terms they don’t quite understand and to explore meanings of terms to ensure that the translated questionnaire is still reflecting the original meanings.

In order to do this, the PRO question is read out to the participant who can either rephrase or give examples to demonstrate how they’ve understood it, like below:

Interviewer: In the past week, have you had a loose or watery stool? Can you please rephrase or explain what this question is asking you.

Participant 1: The question is asking if my poo was wet and liquidy.

Participant 2: Asking me if I’ve had diarrhoea.

Participant 3: *laughs nervously* I don’t want to answer that.

As you can see, some questions can seem personal! It’s natural during the interviews for patients to feel embarrassment, shock, sadness or upset as the questions can touch on sensitive topics. It’s important to support them throughout the interview to make them feel relaxed and reassure them they are in a safe environment where they can respond honestly. 

2.      Read the non-verbal cues

Body language and intonation is as important as verbal language. If the interview is being conducted via telephone, then try to take note of the intonation of voice. Elements such as pauses, sighs, and laughs can all help indicate that something may not be right in their current target language and the questionnaire may require rewording to achieve the true equivalence of source meaning.

If it’s being conducted in person or via video chat, then take the opportunity to put the participant at ease and let their body language tell you more than their words.

3.      Ask leading questions

It’s much better to ask leading questions than closed ones that could be responded with just a ‘yes’ or ‘no’. Probe further as to why a particular question doesn’t make sense to them. Ask them how they could rephrase this in another way to garner more insight into how the participant has understood the item.

4.      Don’t let it get personal

Being asked about your bowel movements or your love life isn’t exactly polite dinner table conversation, but these questions can come up in certain PROs and need to be tested.

When the use of personal questions are deemed too 'awkward' to answer, this is exactly the point where rephrasing or further exploration is needed. It gives the person analysing the report more information to be able to either rephrase or reanalyse the use of certain wording in the target language.

5.      Find the balance

Some patients may want to spill all the beans, and some may be really shy. The interview may be a rare chance for someone to talk about their condition outside of a clinical environment. You want to find the balance of allowing the participant to express themselves openly and respecting their boundaries.

If you’re the interviewer, being respectful and reminding the participant that this is a linguistic exercise rather than a direct question can help to put the patient at ease.

6.      Check cultural issues

Cognitive debriefing also irons 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 concept. Dinner time may imply 17:00 in the UK, but considered as 20:00 in Chile. Or it could be that culturally an idea or certain word equivalence just 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.

Some keys areas to check cultural equivalence are:

·        sports, hobbies, daily life activities, food, colours, emotion and mood terminology, tone of language, taboos, sensitive topics, and so on.

7.      Make sure you’re compliant

Patients are entrusting you with their data and personal information. You must ensure you get consent from the patient that is compliant with any ethics or data handling procedures in that particular country. Whether your study requires full ethical approval from a local Ethics Committee or Institutional Review Board, or ensuring that any data from the debriefing is handled in compliance with GDPR (for those in the EU) to avoid any nasty surprises further down the line.

To conclude…

Patients should have their voice heard throughout research, including in translated versions of PROs. Feedback and testing via cognitive debriefing is one way to achieve this.

The above was just a snapshot into what should be done 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 reviews to reach the perfect translated version of the source language PRO.

Following the practices above should help towards successful cognitive debriefing of a patient-reported outcome but I should mention – you need to use a trained professional in order to have the certification of validation. Particularly if this will then go on to be used in clinical research and be used as support for FDA submissions.


P.S. Have no idea what I’m talking about but still want to learn more?

I’ve spoken more on my work in this Wordbee podcast and written more in this post on linguistic validation.



Dear Anna, thank you for proving a review of this very important work that is cognitive debriefing. Wishing you a Wonderful New Year 2023 ! 🍁

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Nur Ferrante Morales

Linguistic Validation Consultant & Mentor; Cognitive Debriefing Expert; Translator EN/FR>esES; Integrative Health Professional; Poet.

1y

Loved your article! Thank you!

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Gabriela Coutts

znak.co.uk - Polish Translations and Interpreting A qualified, experienced and regulated translator and interpreter - Polish - English - French -

2y

Thank you Anna Richards . The issues relating to PRO you raise in you article occure within public service interpreting context (health, social services, learning etc assessments) - we are often asked to sight translate different forms and questionnaires, usually with no preparation or time to consider whether the questions asked can be accurately reflected in another language. I found your article very interesting and will share with my network.

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Je suis totalement néophyte et je connais très peu ton domaine professionnel, mais cet article est éclairé, posé et plein de bon sens, et les principes de bases peuvent être utilisés dans d'autres domaines... J'ai tout compris du premier coup, bravo 👍

Dalia Fouad

Arabic Medical Translator | Psychiatrist | Copyeditor | Clinical Trials | Pharma | Life sciences | Healthcare | Wellness & Fitness | Mental Health | MedDev | +6 years

3y

Very informative, Anna. Thanks.

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