Cognitive debriefing is an important step in the linguistic validation process, where a research tool or patient questionnaire, like a patient reported outcome (PRO), is tested on a small group of members of the target patient population to ensure that on a conceptual level, the respondents understand the translated questionnaire content as the same as the original. This step is crucial to the linguistic validation process as any misunderstanding or confusion in the interpretation of the questions could result in regulatory rejection or worse, endanger patients’ lives as they lack the fundamental understanding of their treatment.
CSOFT works with pharmaceutical companies and CROs conducting international clinical trials to ensure the highest-quality translation of patient questionnaires in over 250 languages. With our extensive global network of subject matter experts and over 10,000 in-country native linguists, we have the resources to accurately translate and preform cognitive debriefing on a variety of clinical trial documentation.
Steps of Cognitive Debriefing
Cognitive debriefings follow five main steps:
It is important to find participants and investigators within the target population for the cognitive debriefing process. Typically, there are at least 5 participants that meet the criteria needed to represent the larger population in the clinical trial, while the investigators are subject matter experts that are well-versed in cognitive debriefing interviews.
The instrument (or patient questionnaire) is distributed to participants.
The investigator interviews the patients upon completion of the instrument, explaining their reasoning for their answers and understanding of each question. These interviews are best conducted in-person, so the investigator may distinguish questions that are confusing or can lead to confusion for the participant.
Once the interviews are completed, the investigator compiles all responses and interviews into a final report. The report contains the demographics of each participant, questions that posed possible confusion, as well as the investigator’s suggestions for potential solutions for resolving said issue.
Final Review by Project Manager
The final step of the cognitive debriefing process is final review of the report, conducted typically by the project manager. Any potential issues are addressed at this stage and remedied, ensuring that the translation is accurate, and the data is validated. A final proofreading of all documentation is conducted, and afterwards the final report that presents the entire linguistic validation process, including cognitive debriefing.
Cognitive Debriefing for All Types of Instruments
The cognitive debriefing process is mostly used for instruments or tools including:
- Patient Reported Outcomes (PROs)
- Clinical Outcomes Assessments (COAs)
- Quality of Life (QoL) Questionnaires
- Observer Reported Outcomes (ObsROs)
- Clinician Reported Outcomes (ClinROs)
Typically, these instruments contain instructions, questions, and response choices that all require highly-accurate translation. The concept of the documents, in all parts, must be maintained from the source document to the translated version to ensure that the target population understands the document in their native language the same way as someone who reads it in the original source language. In addition, besides creating content that is conceptually equivalent, it’s important that the data from each instrument can be validated regardless of where in the world it was collected, so the global clinical trial can be accepted by regulatory bodies.
To ensure the highest-quality translation of PROs, COAs, QoL questionnaires, ObsROs, and ClinROs, CSOFT follows the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) guidance to meet global regulatory standards. This way, the data submitted to regulatory bodies like the FDA and EMA is approved first time around, saving pharmaceutical companies time, money, and energy.