An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study.

BACKGROUND: Obtaining explicit consent from patients to use their remnant biological samples and deidentified clinical data for research is essential for advancing precision medicine. OBJECTIVE: We aimed to describe the operational implementation and scalability of an electronic universal consent process that was used to power an institutional precision health biobank across a large academic health system. METHODS: The University of California, Los Angeles, implemented the use of innovative electronic consent videos as the primary recruitment tool for precision health research. The consent videos targeted patients aged ≥18 years across ambulatory clinical laboratories, perioperative settings, and hospital settings. Each of these major areas had slightly different workflows and patient populations. Sociodemographic information, comorbidity data, health utilization data (ambulatory visits, emergency room visits, and hospital admissions), and consent decision data were collected. RESULTS: The consenting approach proved scalable across 22 clinical sites (hospital and ambulatory settings). Over 40,000 participants completed the consent process at a rate of 800 to 1000 patients per week over a 2-year time period. Participants were representative of the adult University of California, Los Angeles, Health population. The opt-in rates in the perioperative (16,500/22,519, 73.3%) and ambulatory clinics (2308/3390, 68.1%) were higher than those in clinical laboratories (7506/14,235, 52.7%; P<.001). Patients with higher medical acuity were more likely to opt in. The multivariate analyses showed that African American (odds ratio [OR] 0.53, 95% CI 0.49-0.58; P<.001), Asian (OR 0.72, 95% CI 0.68-0.77; P<.001), and multiple-race populations (OR 0.73, 95% CI 0.69-0.77; P<.001) were less likely to participate than White individuals. CONCLUSIONS: This is one of the few large-scale, electronic video-based consent implementation programs that reports a 65.5% (26,314/40,144) average overall opt-in rate across a large academic health system. This rate is higher than those previously reported for email (3.6%) and electronic biobank (50%) informed consent rates. This study demonstrates a scalable recruitment approach for population health research.

Remote Monitoring of Patients With Hematologic Malignancies at High Risk of Febrile Neutropenia: Exploratory Study.

BACKGROUND: Febrile neutropenia is one of the most common oncologic emergencies and is associated with significant, preventable morbidity and mortality. Most patients who experience a febrile neutropenia episode are hospitalized, resulting in significant economic cost. OBJECTIVE: This exploratory study implemented a remote monitoring system comprising a digital infrared thermometer and a pulse oximeter with the capability to notify providers in real time of abnormalities in vital signs that could suggest early clinical deterioration and thereby improve clinical outcomes. METHODS: The remote monitoring system was implemented and compared to standard-of-care vital signs monitoring in hospitalized patients with underlying hematologic malignancies complicated by a febrile neutropenia episode in order to assess the feasibility and validity of the system. Statistical analysis was performed using the intraclass correlation coefficient (ICC) to assess the consistency between the measurements taken using traditional methods and those taken with the remote monitoring system for each of the vital sign parameters (temperature, heart rate, and oxygen saturation). A linear mixed-effects model with a random subject effect was used to estimate the variance components. Bland-Altman plots were created for the parameters to further delineate the direction of any occurring bias. RESULTS: A total of 23 patients were enrolled in the study (mean age 56, SD 23-75 years; male patients: n=11, 47.8%). ICC analysis confirmed the high repeatability and accuracy of the heart rate assessment (ICC=0.856), acting as a supplement to remote temperature assessment. While the sensitivity and specificity for capturing tachycardia above a rate of 100 bpm were excellent (88% and 97%, respectively), the sensitivity of the remote monitoring system in capturing temperatures >37.8 °C and oxygen saturation <92% was 45% and 50%, respectively. CONCLUSIONS: Overall, this novel approach using temperature, heart rate, and oxygen saturation assessments successfully provided real-time, clinically valuable feedback to providers. While temperature and oxygen saturation assessments lagged in terms of sensitivity compared to a standard in-hospital system, the heart rate assessment provided highly accurate complementary data. As a whole, the system provided additional information that can be applied to a clinically vulnerable population. By transitioning its application to high-risk patients in the outpatient setting, this system can help prevent additional use of health care services through early provider intervention and potentially improve outcomes.

Durable response of anaplastic thyroid carcinoma to FS118, a bispecific LAG-3/PD-L1 antibody, after checkpoint inhibitor progression: a case report.

Anaplastic thyroid cancer represents a rare, highly aggressive form of thyroid cancer with a poor prognosis and an overall survival ranging from 5 to 12 months. Unfortunately, treatment options remain limited, even for patients with a targetable driver mutation. Here, we present a case of a patient with a BRAF V600E-mutated, PD-L1 positive (tumor proportion score of 95%) anaplastic thyroid cancer refractory to standard therapies, including debulking surgery, followed by chemoradiation, who had further progressed on PD-1 monotherapy, and was unable to tolerate BRAF/MEK inhibition. Ongoing treatment with FS118, a bispecific LAG-3/PD-L1 antagonist, has afforded 3 years of disease control, including a late confirmed partial response, with excellent tolerability. Given this response, further investigation is required to delineate the mechanism by which dual PD-L1/LAG-3 blockade by FS118 overcomes initial PD-1 pathway resistance, and therefore, identify which patients are most likely to benefit. Simultaneously, expanded use should be considered for those with refractory disease, especially if PD-L1 positive. Insights Dual PD-L1/LAG-3 blockade may be an effective treatment strategy for refractory metastatic tumors, including anaplastic thyroid cancer.