The Immuno-oncology-Induced Cytokine Release Syndrome Patient Diary: A Content-Valid, Patient-Reported Outcome...

Area of Science:

• Oncology
• Immunology
• Clinical Research

Background:

• Cytokine release syndrome (CRS) is a systemic inflammatory response to infections or immunotherapies.
• CRS symptoms vary widely, from mild to life-threatening.
• Standardized patient-reported data collection for CRS is currently lacking.

Purpose of the Study:

• To develop a novel patient-reported outcome measure (PROM) for capturing patient experiences with CRS.
• To create a standardized tool for monitoring CRS in clinical trials.

Main Methods:

• A comprehensive process including literature review, analysis of clinical trial data, expert interviews, and patient interviews.
• Development of a preliminary conceptual model and iterative refinement through workshops and cognitive debriefing.

Main Results:

• Identification of various CRS signs and symptoms from literature and clinical data.
• Development and refinement of the immuno-oncology (IO)-induced CRS patient diary through expert and patient feedback.
• The diary effectively captures CRS symptom incidence, severity, and impact.

Conclusions:

• The "IO-induced CRS patient diary" is a content-valid tool for monitoring CRS symptoms and impacts in IO clinical trials.
• This PROM offers a standardized patient perspective on IO-induced CRS.
• It addresses the need for consistent assessment beyond traditional clinical evaluations.