Cognitive Debriefing

We begin by identifying and selecting native speakers of the target language who precisely represent the intended customer group. This guarantees that the feedback we receive is relevant and reflective of the target patient demographic.

Our team of professionals thoroughly familiarize themselves with the converted survey to fully understand its content, objectives, and application within the healthcare sector. This step is essential for effectively guiding the participants through the debriefing process and maintaining Patient Centric Clinical Trials.

• Introduction: We explain the study’s purpose to the participants, obtain their informed consent, and ensure they clearly understand their role in the clinical trial documentation process.
• Think-Aloud Method: Participants read the translated PRO items aloud and describe their thoughts as they interpret and respond to each item. This helps identify issues with wording or understanding.
• Probing Questions: Targeted questions explore specific areas of interest, such as the clarity of instructions, the relevance of questions, and the appropriateness of response options.

Examples of probing questions include:

• • “What does this question mean to you?”
  • “Can you explain how you chose your answer?”
  • “Was there anything confusing or unclear about this item?”

• Recording Responses: We carefully document the participants’ feedback, including their verbal responses and non-verbal cues. Recording sessions (with consent) can be valuable for later analysis.
• Note-taking: Thorough notes are taken during the sessions to capture immediate impressions and any contextual information that might be relevant.

• Identify Themes: We analyse the collected data to identify common themes, patterns, and any recurrent issues with the translated PRO instrument.
• Assess Understanding: We determine whether participants consistently understand each item as intended and if any terms or concepts are causing confusion.

We document the outcomes of each session, recording participants’ feedback, any comprehension issues, and suggestions for improvements, and include these findings in the cognitive debriefing report.

Our Cognitive Debriefing process is essential for making sure that translated PRO instruments are comprehensible to the target patient population and accurately convey the original concepts. By following these steps, the translated PRO instruments can be effectively utilized in international clinical trials and other research settings.