Cognitive debriefing interviews
It is important that clinical outcome assessments (COAs) employed in research studies are consistently and correctly interpreted by respondents. Adelphi Values have been at the forefront of the development and refinement of cognitive debriefing interviewing as a central activity in the development and testing of COA instruments. Our cognitive debriefing research has been extensively published and is well accepted by both the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Typically, we employ a mixture of using a ‘think-aloud’ method (asking patients to speak their thoughts aloud as they read and respond to the questionnaire) and following up with specific and detailed debriefing questions to gain insight regarding patient understanding, and the relevance and appropriateness of items, instruction, response options and recall periods. Our skilled interviewers are highly experienced in eliciting feedback from hard-to-reach groups such as young children and patients with low affect.
As part of a mixed methods approach to COA development, Adelphi Values advocate performing pilot testing or feasibility testing prior to the conduct of cognitive debriefing interviews. This involves patients completing the newly-developed patient-reported outcome (PRO) measure (commonly daily diaries completed on an ePRO device) at home in a ‘real world’ setting for a period of several days prior to their interview. This enables respondents to reflect on their actual experience of completing the diary in real-life, rather than having to think hypothetically. This is particularly valuable for children who have difficulty thinking beyond the here and now. Moreover, collection of data during this period can provide early insight into item response distributions and trends which can then be further explored during the cognitive debriefing interviews.