Managing Critical Patient-Reported Outcome Measures in Oncology Settings: System Development and Retrospective Study.

Background: Remote monitoring programs based on the collection of patient-reported outcome (PRO) data are being increasingly adopted in oncology practices. Although PROs are a great source of patient data, the management of critical PRO data is not discussed in detail in the literature.

Objective: This first-of-its-kind study aimed to design, describe, and evaluate a closed-loop alerting and communication system focused on managing PRO-related alerts in cancer care.

Methods: We designed and developed a novel solution using an agile software development methodology by incrementally building new capabilities. We evaluated these new features using participatory design and the Fit between Individuals, Task, and Technology framework.

Results: A total of 8 questionnaires were implemented using alerting features, resulting in an alert rate of 7.82% (36,838/470,841) with 13.28% (10,965/82,544) of the patients triggering at least one alert. Alerts were reviewed by 501 staff members spanning across 191 care teams. All the alerts were reviewed with a median response time of 1 hour (SD 185 hours) during standard business hours. The most severe (red) alerts were documented 56.83% (2592/4561) of the time, whereas unlabeled alerts were documented 27.68% (1298/4689) of the time, signaling clinician concordance with the alert thresholds.

Conclusions: A PRO-based alert and communication system has some initial benefits in reviewing clinically meaningful PRO data in a reasonable amount of time. We have discussed key system design considerations, workflow integration, and the mitigation of potential impact on the burden of care teams. The introduction of a PRO-based alert and communication system provides a reliable mechanism for care teams to review and respond to patient symptoms quickly. The system was standardized across many different oncology settings, demonstrating system flexibility. Future studies should focus on formally evaluating system usability through qualitative methods.