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Importance: Cancer immunotherapy causes a wide range of immune-related adverse events (irAEs) that require close and timely follow-up. Objectives: To compare the efficiency between electronic patient-reported outcomes (ePRO) and traditional follow-up models in cancer immunotherapy. Design, Setting, and Participants: This open-label randomized clinical trial was performed from September 1, 2019, to March 31, 2021. Patients were randomized to the ePRO model intervention or a control group by a computer system. A total of 28 Chinese tertiary care hospitals participated. Patients who were receiving cancer immunotherapy and could use smartphones or computers were eligible. A total of 300 patients were screened and 278 (92.7%) were enrolled. Interventions: The control group was followed up using traditional methods, including clinic visits every 21 days and telephone follow-up every 3 months. In the intervention group, the ePRO follow-up model included a questionnaire of common symptoms and an image recognition function to evaluate grades of typical irAEs. Patients completed questionnaires weekly and uploaded pictures of results between visits. When grade 1 or 2 irAEs occurred, standardized advice was sent automatically. If grade 3 or 4 irAEs were reported, the model alerted the health care team for assessment and intervention immediately. All patients were followed up for 6 months or until treatment completion. Main Outcomes and Measures: Incidence of serious (grades 3 to 4) irAEs, emergency department (ED) visits, quality of life (QOL), time spent implementing the ePRO model, rate of treatment discontinuation, and death were compared between groups post intervention. Results: A total of 278 patients (mean SD age, 58.8 12.7 (range, 27-78) years; 206 men 74.1%) were included in the analysis, consisting of 141 in the intervention group and 137 in the control group. At the postintervention evaluation, the intervention group showed a reduced incidence of serious irAEs (29 of 141 20.6% vs 46 of 137 33.6%; hazard ratio HR, 0.51 95% CI, 0.30-0.88; P = .01), fewer ED visits (23 of 141 16.3% vs 41 of 137 29.9%; HR, 0.46 95% CI, 0.26-0.81; P = .01), a lower rate of treatment discontinuation (5 of 141 3.6% vs 15 of 137 11.0%; HR, 0.30 95% CI, 0.11-0.85; P = .02), a higher QOL level (mean SD score, 74.2 15.1; 95% CI, 71.7-76.9 vs 64.7 28.5; 95% CI, 61.0-68.4; P = .001), and less time implementing follow-up (mean SD, 8.2 3.9; 95% CI, 5.0-10.6 minutes vs 36.1 15.3; 95% CI, 33.6-38.8 minutes; P < .001). However, there were no significant differences between groups in death rates (2 of 141 1.4% vs 5 of 137 3.6%; HR, 0.38 95% CI, 0.07-1.99; P = .28). Conclusions and Relevance: This randomized clinical trial found that the ePRO follow-up model can improve safety and QOL of patients receiving cancer immunotherapy as well as reduce time spent monitoring. This model may provide reliable information and management recommendations. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2100052819.
Zhang et al. (Thu,) studied this question.