Background:
Immune checkpoint inhibitors (ICIs) have transformed outcomes across multiple cancers but are associated with immune-related adverse events (irAEs), which can affect any organ, arise unpredictably, and be life-threatening. Between clinic visits, patients and caregivers bear primary responsibility for recognising and reporting symptoms, yet timely identification of irAEs is challenging. Electronic patient-reported outcome (ePRO) symptom monitoring offers a proactive, structured approach to capture symptoms in real time, potentially facilitating early intervention and improving outcomes.
Methods:
We conducted a multi-phase program to co-design and evaluate an ePRO symptom monitoring system tailored for ICI toxicities. Work packages included: (1) systematic reviews of ICI-related health impacts and existing ePRO systems; (2) a qualitative study guided by the Consolidated Framework for Implementation Research to identify barriers facilitators to routine ePRO use as well as theory-informed implementation strategies; (3) co-design of system content, workflows, alert thresholds, and self-management advice with patients, caregivers, and clinicians; and (4) usability and acceptance testing of a prototype integrated into the Epic electronic medical record.
Results:
The co-designed ePRO system incorporated validated symptom items, real-time clinician alerts for severe or worsening symptoms, and patient-facing dashboards to track symptom trends. Usability testing demonstrated high acceptance among clinicians and patients, with clinician usability rated highest. Key facilitators included EMR integration, clear escalation pathways, and alignment with local workflows. Identified challenges included digital equity considerations and the need for sustained organisational support.
Conclusion:
Co-designing an ePRO symptom monitoring system for ICI toxicities is feasible and may help support patients and caregivers to recognise and report potential side-effects between visits to hospital. Future work will pilot the system in routine care and adapt it for other systemic therapies.