Session (CTI)

PURPOSE: It is critical to establish meaningful change thresholds for clinical outcomes assessments (COA) used to evaluate key efficacy endpoints in clinical trials for new therapies. Qualitative methods are a complementary approach to quantitative methods, but often require complex scoring algorithms to be presented to patients to seek their perspectives on multi-item measure changes. This workshop will focus on how to generate vignettes to discuss varying levels of change in COA scores with patients, and considerations for implementation and analyses. Participants will generate vignettes and practice exploring changes in outcomes using AI-based and manual methods. DESCRIPTION: Workshop attendees will obtain a working knowledge of applying vignette-style methods in qualitative interviews to explore meaningful change in COA scores with patients. The workshop moderator, Helen Kitchen, will introduce the topic by providing background on the importance of estimating meaningful change thresholds to interpret clinical trial COA scores, describing methodologies referenced in the FDA Patient-Focused Drug Development (PFDD) Guidance (10 min). One such method, vignettes, has been used by the presenters in multiple qualitative studies to explore patient perspectives in meaningful change. Dr Piper Fromy will describe the triangulation of these qualitative methods and quantitative methods to establish COA interpretation thresholds (10 min). Dr Catherine Bottomley will guide workshop participants in developing their own vignettes to explore meaningful change in complex multi-item COA scores (20 min). Natalie Aldhouse will demonstrate AI-based and manual methods for implementing vignettes in qualitative interviews and conducting real-time analyses (20 min). This interactive workshop will be valuable to COA researchers working in industry, academic, and clinical settings who are interested in using qualitative methods to explore meaningful change thresholds in complex COA scores.