In an earlier blog (What is Linguistic Validation?) we discussed what is involved with linguistic validation; we now turn our attention to explaining cognitive debriefing, sometimes referred to as pilot testing. As stated before, linguistic validation and cognitive debriefing are needed to qualify an instrument’s validity and to protect clinical research data pools. The US Food and Drug Administration requires linguistic validation and cognitive debriefing to show content validity for all submitted translations.
Cognitive debriefing shows that the respondents to a questionnaire or instrument understand the intent of the queries, and that the instrument is both culturally acceptable and contextually relevant to target populations. Cognitive debriefing verifies that translations of all items are interpreted in the same way across target populations and regions and have the same content validity.
What Is Cognitive Debriefing?
Cognitive debriefing is the process by which an instrument or patient questionnaire is actively tested among representatives of the target population and target language group to determine if the respondents understand the questionnaire the same as the original would be understood. Cognitive debriefing is done to test the level of comprehension or understanding of a translation by the target audience, and/or to test alternative translations. It determines if translations would be deemed inappropriate or confusing by the target population.
Cognitive debriefing is particularly important when it comes to medical information when a mistranslation or even a misunderstanding of a translation could result in medical complications or the rejection of an entire clinical research project. If an item or question on the instrument or questionnaire could be interpreted in more than one way then it may need to be updated or modified to protect the patients and the clinical research trial data.
Cognitive debriefing is mostly used for Clinical Outcomes Assessments (COAs), such as Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs) and Observer Reported Outcomes (ObsROs) and for Quality of Life (QOL)questionnaires. These are often called “instruments” and include instructions, items (also known as questions) and response categories or response choices to those items/questions.
The goal of cognitive debriefing is to determine equivalence of concept. Concept equivalence relates to the phrasing of the translation in comparison to the source material and goes beyond a literal translation to focus on producing phrases that native speakers would understand the same way.
General Steps Involved With Cognitive Debriefing
Once the steps involved with linguistic validation are complete (see our previous blog for details on the linguistic validation process), the harmonized version of the instrument should undergo cognitive debriefing as an additional step to verify that cross-cultural adaptation is relevant for the target language(s) and culture(s).
Here is an overview of the steps involved with cognitive debriefing:
Step 1: Recruit Respondents
Before cognitive debriefing can begin, you or your project manager must recruit in-country for both investigators and patients or respondents.
For investigators, you will want to recruit in-country professionals experienced in interviewing techniques, such as psychologists, psychiatrists or social workers. Ideally the investigators will live in the target countries as well as being native speakers of the target language. Investigators should have a strong medical, linguistics, psychology and/or healthcare background. They should also be experts in the methodology of standardized instrument development and assessment procedures, with a clear understanding of the importance of maintaining accuracy throughout the project. These investigators will conduct the cognitive debriefing interviews.
Patients or respondents that match the target population should be selected. For each questionnaire, language group and target culture, you will recruit a range of respondents that reflect the potential instrument respondent population. A typical cognitive debriefing interview is typically made up of 5 or more respondents that meet the age criteria specified, diagnosed condition and other representative criteria of the target population for that instrument.
Step 2: Conduct Interview
In the interview stage, respondents complete the questionnaire and then answer questions to explain their understanding of each question or item on the questionnaire or instrument. In the interview the respondents restate in their own words what they think each translated item means . Interviews are best conducted live and in-person to catch the nuances and subtleties of responses. During the interview, the investigator is to lead an examination of the responses to the questions to discover errors and difficulties in the translated instruments. The interview helps to find items or questions that are confusing or misunderstood by the target population.
Step 3: Generate Report
After interviews are complete, an interview report is generated. The interview report should include both demographic and medical details of the interviewees that may have a bearing on the instrument and a detailed account of patients’ understanding of all items, even those that may seem unproblematic. The report should include how many subjects were interviewed, how old they are, how long it took to complete the instrument (or questionnaire) and any difficulties or confusions that came up. It may also include investigator recommendations or solutions to resolving confusion or difficulties.
Step 4: Review And Finalization By Project Manager
Once the interview report has been received, the project manager should review to ensure that the reports are complete and that all issues have been addressed. Any difficulties or confusions that were discovered during the interview stage should be addressed and the translations should be revised accordingly. The project manager should make revisions as needed to ensure that the final validated measures are clear, precise and understood for equivalency of meaning across all target languages.
Once the translation is finalized, a final round of proofreading should occur. Then a final report detailing the entire linguistic validation and cognitive debriefing process with the final translations is released.
Summary Of Cognitive Debriefing
Cognitive debriefing helps ensure that measurement properties of the items will be the same across different language versions of the instrument, that data can be validly pooled across international sites and that the process will meet FDA and EMEA guidelines.
Cognitive debriefing is done to ensure that the translation states in the target language what the original in the source language intended. The ultimate goal of linguistic validation and cognitive debriefing is to produce translations that are conceptually equivalent to the original source document.
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has made recommendations on how to properly conduct cognitive debriefing. When choosing a language service provider, it is most important to find one that follows ISPOR-compliant processes and methodologies.
What experiences have you had with cognitive debriefing? Please share your thoughts in our comments section and like and share this blog socially.