Unraveling assumptions about clinical relevance in patient-reported outcome data

Purpose The interpretation of patient-reported outcomes (PROs) in oncology research lacks a shared understanding of clinical relevance among interest groups. Terms like minimal important differences and clinically meaningful change aim to aid interpretation but remain inconsistently conceptualized. This study explores interest-holders’ perspectives to support setting-specific definitions of clinical relevance in PRO research. Methods An online survey was distributed via international networks to multi-professional interest-holders. Responses to an open-ended question regarding participants’ understanding of clinical relevance were analyzed using qualitative content analysis to identify recurring themes and patterns within the quotes. Results The survey included 92 participants: clinical practitioners (38.5%), academic researchers (47.3%), industry researchers (8.8%), and patients/patient representatives (rep.) (5.5%). Five clusters emerged reflecting facets of clinical relevance: (a) patient value (e.g., impact on well-being), (b) practical implications (e.g., treatment changes), (c) external criteria (e.g., physiological changes), (d) statistical approaches (e.g., 10% difference), and (e) proxy value (e.g., physician’s perspective). Practitioners primarily focused on patient value (55.6%), while academic researchers showed a similar distribution but with greater variance across clusters. In contrast, industry researchers more frequently emphasized external criteria (20.0%) and proxy value (20.0%) compared to other groups. Patient value and statistical approaches were not mentioned by the same participants, nor were external criteria and practical implications . Conclusion Conceptual understanding of clinical relevance varies by professional background, highlighting its multifaceted nature. These findings, identifying distinct conceptual clusters across interest groups, provide a foundation for developing harmonized, context-specific definitions of clinical relevance in PRO research.