Cognitive Debriefing: Get Fully Accurate Medical Content

When it comes to medical translations, accuracy and providing content that target audiences understand completely is paramount. The involved parties need to be aware of the specifics of any medications, trials, or procedures so that possible lawsuits and critical errors can be avoided. That is why medical transition services often come with that extra level of quality assurance that can guarantee a flawless delivery of information.

For medical questionnaires and instruments, this level of quality assurance is known as Cognitive Debriefing. But what does this service entail? How can it help safeguard quality? And which best practices should be followed?

What Is Cognitive Debriefing?

Cognitive Debriefing

 refers to the process of confirming the quality of medical instruments or patient questionnaires by testing them on the target audience and language groups. These groups will communicate their understanding of the translation, through which it can be determined if the content quality is fully accurate, acceptable, and relevant for each member in the testing group. If any dubiousness is registered, if certain parts of the content are inappropriate, or if different participants in the debriefing demonstrate varying levels of understanding, the translation will need to be revised.

Cognitive debriefing is of vital importance when it comes to validating medical content and avoiding possible misunderstandings or even lawsuits caused by mistranslations. The rigorous quality assurance implemented through Cognitive Briefing ensures the following:

• Process compliance with FDA and EMEA regulations
• Content validation
• Cultural and contextual relevance and the use of language fully adapted to the target audience

In that sense, Cognitive Debriefing takes it one step further than the quality baseline of linguistic accuracy of the source text and into conceptual and contextual accuracy and relevance. Only this way, you can preserve the integrity of your medical questionnaires and instruments.

Cognitive Debriefing is predominantly used for:

• Clinical Outcomes Assessments (COAs)  this includes Patient-Reported Outcomes (PROs)
• Clinician Reported Outcomes (ClinROs)
• Observer Reported Outcomes (ObsROs)
• Quality of Life (QOL) questionnaires

Pro tip! Do you want to learn more about the best practices in medical translation? Then check out our blog in Medical Translation: Best Practices That Ensure Accuracy And Consistency!

Cognitive Debriefing: The Vital Key In The Linguistic Validation Process

Linguistic Validation and the Cognitive Debriefing process need to follow a series of best practices in order to be efficient and effective. And a big part of this requires detailed preparation and specific translation methods!

Linguistic Validation

Prior to actually putting together a testing group,  linguists follow best translation practices so that minimum, if any, alterations will be needed.  Native, in-country subject-matter specialists are set the task of translating the content with utmost diligence and extraordinary attention to detail throughout the process of Linguistic Validation. The goal of Linguistic Validation is to ensure that the questionnaire or the instrument has the same conceptual and construct value as the original document. In order to achieve this, the translation will have to go through various phases:

• Assessment. Before the translation can be done, the content will go through an assessment to weed out any ambiguities and foresee possible difficulties. If needed, a meeting will be set up with the client to find suitable alternatives to ambiguous content.
• Forward translation. Here, no less than two independent linguists will translate the source content. As mentioned before, these linguists should be in-country natives with years of translation experience specifically in the medical field.
• Next, comes reconciliation! The forward translations provided by each expert should be compared and combined into the most qualitative and conceptually accurate version. The goal is to create a document where not only the language, but also the expected level of understanding is adapted to the target audience.
• Once a single translation is created, the reconciled translation goes through the process of back translation, where at least two independent linguists will translate the content back into the source language.
• The back translations will be provided to the project manager and will be reviewed according to their loyalty to the source document. In light of the evaluation, an optimized translation will be delivered.
• Next comes the Cognitive Debriefing process, which focuses on assembling respondents, the interview, and report generation. We’ll get into this more fully in the next chapter!
• Project Manager Review and Final Translation: Once the interviews have been conducted, the Project Manager should make sure to review each interview in detail and confirm that all the information has been included. Any difficulties or misunderstandings raised by the investigator should be noted and included in the final translation. Once the translation has been revised according to the investigator’s notes, an additional proofreading stage is implemented so that all possible errors are weeded out.

Cognitive Debriefing Best Practices 

1. Assembling the Testing Group Of Patients and Investigators

We bring together in-country patients and investigators to contribute to the process.

• When it comes to the investigators, it will be best to select in-country native experts with a solid medical and linguistic background and experience in interviewing techniques. This can include social workers, psychologists, or psychiatrists. They should have profound knowledge of the assessment process to conduct the interviews as part of the Cognitive Debriefing Process.
• The patients selected will need to match the target groups and audiences. This means that a different group of investigators will need to be put together for each language, culture, and questionnaire. We recommend that you put together groups of no less than 5 patients who meet the criteria in terms of age, applicable condition, and any other standards your target group meets.