Efficiency of Electronic Health Record Assessment of Patient-Reported Outcomes After Cancer Immunotherapy: A Randomized Clinical Trial.
Efficiency of Electronic Health Record Assessment of Patient-Reported Outcomes After Cancer Immunotherapy: A Randomized Clinical Trial.
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癌症免疫疗法后，电子健康记录评估患者报告结果的效率：一项随机临床试验。
DOI：
10.1001/jamanetworkopen.2022.4427
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发表时间：
2022-03-01
影响因子：
13.8
通讯作者：
Cong L
中科院分区：
文献类型：
--
作者：
Zhang L;Zhang X;Shen L;Zhu D;Ma S;Cong L
Can an electronic patient-reported outcome (ePRO) model improve outcome in cancer immunotherapy compared with a traditional model? In this randomized clinical trial of 278 patients from 28 Chinese hospitals comparing ePRO and traditional follow-up models, the intervention group showed a reduced incidence of serious immune-related adverse events, fewer emergency department visits, a lower rate of treatment discontinuation, a higher quality of life, and less time needed to implement the model. These findings suggest that the ePRO follow-up model is efficient and may provide reliable information and management recommendations in patients receiving immunotherapy for cancer. This randomized clinical trial investigates the efficiency of an application for an electronic patient-reported outcome follow-up system compared with a traditional model for safety and quality of life among patients receiving cancer immunotherapy. Cancer immunotherapy causes a wide range of immune-related adverse events (irAEs) that require close and timely follow-up. To compare the efficiency between electronic patient-reported outcomes (ePRO) and traditional follow-up models in cancer immunotherapy. 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. 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. 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. 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). 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. Chinese Clinical Trial Registry Identifier: ChiCTR2100052819
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影响因子：
5.6
作者：
Kumar V;Chaudhary N;Garg M;Floudas CS;Soni P;Chandra AB
通讯作者：
Chandra AB
影响因子：
1.3
作者：
Le, Sonny;Chang, Brandon;Chan, Andrea
通讯作者：
Chan, Andrea
影响因子：
7.4
作者：
Girgis A;Durcinoska I;Levesque JV;Gerges M;Sandell T;Arnold A;Delaney GP;PROMPT-Care Program Group
通讯作者：
PROMPT-Care Program Group
影响因子：
1.1
作者：
Rubin, Krista M
通讯作者：
Rubin, Krista M
影响因子：
50.5
作者：
Haanen, J. B. A. G.;Carbonnel, F.;Jordan, K.
通讯作者：
Jordan, K.