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Updated: Jun 9, 2025
Predictive Immune Modeling of Solid Tumors
Published on: February 25, 2020
Patient-reported outcome measure (PROM) programs for monitoring symptoms among patients treated with immunotherapy: a
Sylvie D Lambert1,2, Sara Soldera3, Jordana Kazdan1
1St Mary's Hospital Research Centre, Montreal, QC H3T 1M5, Canada.
Background:
Monitoring toxicities among patients receiving immune checkpoint inhibitors using patient-reported outcome measures (PROMs) is relatively recent. This scoping review aims to guide decision making in the development of PROMs programs for patients receiving immune checkpoint inhibitor therapy.
Methods:
Four electronic databases were searched from inception to January 2024. Data on PROM programs for patients receiving immune checkpoint inhibitors (eg, PROMs used, frequency) were extracted. Two authors with established interrater reliability screened titles, abstracts, and full texts. A narrative synthesis identified patterns in the data.
Results:
A total of 22 articles described 16 unique multicomponent, electronic PROM programs for patients receiving immune checkpoint inhibitor therapy, mainly developed for remote monitoring of toxicities between appointments. Patients typically completed 18-26 items from the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) or Common Terminology Criteria for Adverse Events (CTCAE) weekly, with high adherence and satisfaction. Commonly monitored symptoms were diarrhea, fatigue, shortness of breath, cough, nausea, decreased appetite, rash, joint pain, pain, and mood. Other features of PROMs programs included clinician alerts, with some programs only flagging symptoms that had an impact on treatment. Some programs also or only sent alerts to patients to contact their clinicians and gave access to symptom management information. In terms of efficacy, the only consistent finding was an increase in quality of life.
Conclusions:
The findings of this scoping review provide some indication as to which components of a PROM program are promising. However, as the evidence base for using PROMs among patients receiving immune checkpoint inhibitors is growing, many questions remain, including which symptoms to monitor, using which PROM, and at what frequency. More trials are needed to answer these questions and to determine how best to implement PROMs among patients receiving immune checkpoint inhibitor in clinical practice.
Insights
Patient-reported outcome measures (PROMs) programs show promise for monitoring immune checkpoint inhibitor toxicities. While effective for remote symptom tracking, further trials are needed to optimize PROM selection and frequency for clinical practice.
Area of Science:
- Oncology
- Digital Health
- Patient-Reported Outcomes
Background:
- Monitoring immune checkpoint inhibitor (ICI) toxicities using patient-reported outcome measures (PROMs) is an emerging area.
- This scoping review addresses the need for guidance in developing PROM programs for patients on ICI therapy.
Purpose of the Study:
- To guide decision-making in the development of PROM programs for patients receiving immune checkpoint inhibitor therapy.
- To identify current practices and components of PROM programs for ICI patients.
Main Methods:
- A comprehensive scoping review of four electronic databases was conducted up to January 2024.
- Data extraction focused on PROMs used and their frequency in ICI patient monitoring.
- Narrative synthesis was employed to identify patterns in the collected data.
Main Results:
- Sixteen unique electronic PROM programs were identified across 22 articles, primarily for remote toxicity monitoring.
- Patients frequently used the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) or Common Terminology Criteria for Adverse Events (CTCAE) with high adherence.
- Commonly monitored symptoms included diarrhea, fatigue, and shortness of breath, with clinician alerts and symptom management information being key features. Increased quality of life was a consistent efficacy finding.
Conclusions:
- Current PROM programs offer insights into effective components for monitoring ICI toxicities.
- Significant questions remain regarding optimal symptom selection, PROM tools, and monitoring frequency.
- Further clinical trials are essential to refine PROM implementation in routine clinical practice for ICI patients.
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