PCR51 Qualitative Synthesis of Cognitive Debriefing and Usability Testing Studies to Inform Good Electronic Clinical Outcome Assessment Design

Abstract

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.