免疫肿瘤治疗诱导的细胞因子释放综合征患者日记：一种内容有效的患者报告结局测量工具

A comprehensive, multistep evidence-generation process was employed, including several research steps: a literature review and analysis of Sanofi clinical trial adverse event data, semi-structured interviews with clinical experts, advisory board meetings with clinical trial investigators, concept elicitation interviews with patients who experienced CRS, a PROM development workshop, cognitive debriefing interviews with clinical trial investigators, and cognitive debriefing interviews with patients.

This review identified various CRS-related signs and symptoms from literature and anonymized safety data from clinical trials. Clinical experts validated the preliminary conceptual model (CM) and identified additional relevant symptoms. Patient interviews revealed further symptoms and impacts, leading to the development of the immuno-oncology (IO)-induced CRS patient diary. This PROM was refined through iterative feedback from clinical experts and patients, ensuring it effectively captures the incidence, severity, and impact of CRS symptoms.

The "IO-induced CRS patient diary" can be considered a content-valid tool for capturing and monitoring the most important patient-reportable symptoms and impacts of CRS in IO clinical trials. This PROM can provide a standardized understanding of IO-induced CRS from the patient perspective, where to date this has been mainly clinically assessed using diverse assessments.