The Cystic Fibrosis (CF) treatment landscape has changed dramatically over the past decade with the advent of highly effective Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulator therapies. As patients on modulators experience improved clinical stability and longer life expectancy, traditional patient‑reported outcome (PRO) measures face increasing challenges in capturing meaningful variation in patients’ experiences. Ceiling effects and reduced sensitivity threaten the interpretability and utility of legacy instruments developed prior to the CFTR modulator era. These changes underscore the need to modernize CF‑specific PRO measures while preserving continuity with decades of historical data.

The Cystic Fibrosis Questionnaire‑Revised (CFQ‑R) has long served as the gold‑standard PRO instrument in CF clinical research. However, as patient experiences evolve, PRO science must adapt to ensure continued relevance, interpretability, and regulatory credibility. IQVIA is pleased to announce our collaboration with the CFQ-R’s developer Dr. Alexandra Quittner. Together, we launched the Crosswalk Project to develop the CFQ‑M: new, modulator‑specific versions of the CFQ‑R designed to better reflect the experiences of people with cystic fibrosis (PWCF) on modulator therapies while maintaining alignment across age‑specific versions.

Central to the CFQ‑M development approach is a strong qualitative foundation, including concept elicitation and cognitive debriefing, to ensure that item content truly captures the new experiences of living with CF. Today, while modulator therapies have brought remarkable physical changes to PWCF, there is no reliable tool to assess all aspects of health-related quality of life (HRQOL) in this population. In addition, emerging data indicates that there are serious neuropsychiatric side-effects associated with modulator therapy and these also need to be included. The Crosswalk Project utilizes rigorous PRO development methodology to calibrate new concepts in a familiar format, enabling meaningful interpretation of CFQ‑M scores alongside existing CFQ‑R data. This approach protects the value of historical datasets while supporting innovation in endpoint development for future trials.

Join IQVIA Quality Metric’s Senior Scientist, Mark Kosinski, and CFQ-R Developer Dr. Alexandra Quittner for a live fireside chat as they discuss:

• Why the modulator era necessitates a re‑examination of established CF PRO measures
• How qualitative research anchors the development of the CFQ‑M
• How the Crosswalk Project will link the legacy CFQ-R and new CFQ-M on a common scale for side-by-side interpretation
• Why continuity, trust, and interpretability are essential for adoption by sponsors, regulators, clinicians, and the CF community
• How the broader CF community can get involved to shape the ongoing CFQ-M development project