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- Title
Evaluation of Technology-Enabled Monitoring of Patient-Reported Outcomes to Detect and Treat Toxic Effects Linked to Immune Checkpoint Inhibitors.
- Authors
Msaouel, Pavlos; Oromendia, Clara; Siefker-Radtke, Arlene O.; Tannir, Nizar M.; Subudhi, Sumit K.; Gao, Jianjun; Wang, Yinghong; Siddiqui, Bilal A.; Shah, Amishi Y.; Aparicio, Ana M.; Campbell, Matthew T.; Zurita, Amado J.; Shaw, Leah K.; Lopez, Lidia P.; McCord, Heather; Chakraborty, Sandip N.; Perales, Jacqueline; Lu, Cong; Van Alstine, Michael L.; Elashoff, Michael
- Abstract
Key Points: Question: Can a technology-enabled, dynamically adaptive protocol be efficiently used to provide early and accurate detection of toxic effects to immune checkpoint inhibitors? Findings: In this cohort study including 47 individuals with genitourinary cancers, a median patient adherence rate of 74% and a care team–automated alert review rate of 73% within 3 days without incurring the cost of increasing care team staffing was found. Dizziness, nausea and vomiting, and shortness of breath were the symptoms with the highest positive predictive value for adverse events requiring acute interventions. Meaning: The findings of this study suggest that technology-enabled monitoring of patient-reported outcomes may provide a useful model for delivering complex care remotely in patients receiving immune checkpoint inhibitors. Importance: Immune checkpoint inhibitors can produce distinct toxic effects that require prompt recognition and timely management. Objective: To develop a technology-enabled, dynamically adaptive protocol that can provide the accurate information needed to inform specific remedies for immune toxic effects in patients treated with immune checkpoint inhibitors. Design, Setting, and Participants: An open-label cohort study was conducted at a single tertiary referral center from September 6, 2019, to September 3, 2020. The median follow-up duration was 63 (interquartile range, 35.5-122) days. Fifty patients with genitourinary cancers treated with immune checkpoint inhibitors were enrolled. Interventions: A fit-for-purpose electronic platform was developed to enable active patient and care team participation. A smartphone application downloaded onto patients' personal mobile devices prompted them to report their symptoms at least 3 times per week. The set of symptoms and associated queries were paired with alert thresholds for symptoms requiring clinical action. Main Outcomes and Measures: The primary end point of this interim analysis was feasibility, as measured by patient and care team adherence, and lack of increase in care team staffing. Operating characteristics were estimated for each symptom alert and used to dynamically adapt the alert thresholds to ensure sensitivity while reducing unnecessary alerts. Results: Of the 50 patients enrolled, 47 had at least 1 follow-up visit and were included in the analysis. Median age was 65 years (range, 37-86), 39 patients (83%) were men, and 39 patients (83%) had metastatic cancer, with the most common being urothelial cell carcinoma and renal cell carcinoma (22 [47%] patients each). After initial onboarding, no further care team training or additional care team staffing was required. Patients had a median study adherence rate of 74% (interquartile range, 60%-86%) and 73% of automated alerts were reviewed within 3 days by the clinic team. Symptoms with the highest positive predictive value for adverse events requiring acute intervention included dizziness (21%), nausea/vomiting (26%), and shortness of breath (14%). The symptoms most likely to result in unnecessary alerts were arthralgia and myalgia, fatigue, and cough. Conclusions and Relevance: The findings of this cohort study suggest an acceptable and fiscally sound method can be developed to create a dynamic learning system to detect and manage immune-related toxic effects. This cohort study conducts an interim analysis of an electronic platform developed for patients to report symptoms possibly related to the toxic effects of immune checkpoint inhibitors.
- Subjects
IMMUNE checkpoint inhibitors; MEDICAL technology; HEALTH outcome assessment; PATIENT monitoring; IMMUNOTHERAPY; DRUG toxicity
- Publication
JAMA Network Open, 2021, Vol 4, Issue 9, pe2122998
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2021.22998