Efficiency of Electronic Health Record Assessment of Patient-Reported Outcomes After Cancer Immunotherapy
Authors: Liyan Zhang, Xiaotian Zhang, Lin Shen, Dan Zhu, Saili Ma, Lin Cong
Journal: JAMA Network Open (2022)

<h3>Importance</h3> Cancer immunotherapy causes a wide range of immune-related adverse events (irAEs) that require close and timely follow-up. <h3>Objectives</h3> To compare the efficiency between electronic patient-reported outcomes (ePRO) and traditional follow-up models in cancer immunotherapy. <h3>Design, Setting, and Participants</h3> 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. <h3>Interventions</h3> 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. <h3>Main Outcomes and Measures</h3> 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. <h3>Results</h3> 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];<i>P</i> = .01), fewer ED visits (23 of 141 [16.3%] vs 41 of 137 [29.9%]; HR, 0.46 [95% CI, 0.26-0.81];<i>P</i> = .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];<i>P</i> = .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];<i>P</i> = .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;<i>P</i> &lt; .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];<i>P</i> = .28). <h3>Conclusions and Relevance</h3> 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. <h3>Trial Registration</h3> Chinese Clinical Trial Registry Identifier:ChiCTR2100052819