OBJECTIVES: Regulatory agencies are placing increasing importance on the patient voice in clinical drug development. The FDA’s Patient-Focused Drug Development guidances emphasize the importance of high-quality measures and recommend developers follow best practices when designing clinical outcome assessments (COA) to avoid common issues that could interfere with respondent understanding as intended. The gold standard for measuring respondent understanding is the cognitive interview or cognitive debriefing (CD). However, access to the findings of CDs across a diversity of therapeutic areas is limited. Therefore, the objective of this research was to perform a qualitative synthesis of cognitive debriefing and usability testing (CD/UT) studies of electronic COA (eCOA) across several therapeutic areas to ascertain common issues identified by patients/caregivers to help inform good eCOA design.

METHODS: A retrospective analysis was performed of 55 CD/UT studies conducted between 2013 and 2022 using Clario eCOA devices. Study findings, such as interpretation or usability issues, were pooled to make recommendations on best practices for good eCOA design.

RESULTS: Of 55 studies included in the analysis, 35 were CD for participant understanding with UT, 18 were CD for paper-to-electronic equivalency with UT, and 2 were UT only. A total of 132 assessments were included. Data were collected from 851 participants of which 17% were children/adolescents and 16% were caregivers. In all studies, UT was rated well, and issues with usability were rare. The most common feedback was preference for larger font size, highlighting the significance of the FDA’s recommendation for accessibility features. Interpretation issues included interpretation of clinical terms such as signs/symptoms (e.g. aura), recall period (e.g. time period of “yesterday”), or anatomical location (e.g. abdomen, nasal area).

CONCLUSIONS: Qualitative synthesis of CD/UTs of eCOAs helps identify common issues with respondent understanding and key areas of focus when designing a COA. Further analysis will be done to reveal patient population-specific findings.