Comparing body temperature measurements using the double sensor method within a wearable device with oral and core body temperature measurements using medical grade thermometers-a short report.

Introduction: Body temperature is essential for diagnosing, managing, and following multiple medical conditions. There are several methods and devices to measure body temperature, but most do not allow continuous and prolonged measurement of body temperature. Noninvasive skin temperature sensor combined with a heat flux sensor, also known as the "double sensor" technique, is becoming a valuable and simple method for frequently monitoring body temperature. Methods: Body temperature measurements using the "double sensor" method in a wearable monitoring device were compared with oral and core body temperature measurements using medical grade thermometers, analyzing data from two prospective clinical trials of different clinical scenarios. One study included 45 hospitalized COVID-19 patients in which oral measurements were taken using a hand-held device, and the second included 18 post-cardiac surgery patients in which rectal measurements were taken using a rectal probe. Results: In study 1, Bland-Altman analysis showed a bias of -0.04°C [0.34-(-0.43)°C, 95% LOA] with a correlation of 99.4% (p < 0.001). In study 2, Bland-Altman analysis showed a bias of 0.0°C [0.27-(-0.28)°C, 95% LOA], and the correlation was 99.3% (p < 0.001). In both studies, stratifying patients based on BMI and skin tone showed high accordance in all sub-groups. Discussion: The wearable monitor showed high correlation with oral and core body temperature measurements in different clinical scenarios.

Clinical Characteristics, Response to Platinum-Based Chemotherapy and Poly (Adenosine Phosphate-Ribose) Polymerase Inhibitors in Advanced Lung Cancer Patients Harboring BRCA Mutations.

The oncogenic role and clinical relevance of BRCA mutations in NSCLC remain unclear. We aim to evaluate the characteristics and clinical outcomes of patients with NSCLC harboring BRCA mutations treated at Hadassah Medical Center (HMC). We retrospectively assessed all patients with advanced NSCLC who underwent next-generation sequencing (NGS) and were found to have pathogenic somatic BRCA mutations (p-BRCA). We compared clinical outcomes in NSCLC patients with wild-type BRCA (wt-BRCA) matched by age, stage, gender, smoking, PDL-1 and driver mutations. Between 2015 and 2022, we evaluated 598 patients with advanced NSCLC using NGS and found 26 patients with p-BRCA, of whom 17 (65.4%) were carriers of germline BRCA variants and represented 1% of all BRCA carriers HMC. The median age of diagnosis was 67 years old (40-78), 13 patients (50%) had a history of smoking and 9 patients (34.6%) had additional driver mutations (EGFR, ALK, BRAF, MET or ERBB2). Objective response rate and median progression-free survival (PFS) for first-line platinum-based chemotherapy in the p-BRCA group compared to wt-BRCA controls were 72.2% and 16 months (CI 95%, 5-22), compared to 47.4% and 7 months (CI 95%, 5-9), respectively, and HR for PFS was 0.41 (CI 95%, 0.17-0.97). Six patients in the p-BRCA group were treated with advanced-line poly (adenosine-phosphate-ribose) polymerase inhibitors (PARPi), with a durable response observed in four patients (66%). In this cohort, patients with NSCLC harboring p-BRCA exhibit high-sensitivity PARPi and a prolonged response to platinum, suggesting some oncogenic role for BRCA mutations in NSCLC. The results support further prospective trials of the treatment of NSCLC harboring p-BRCA with PARPi.

Clinical validation of a wearable respiratory rate device: A brief report.

BACKGROUND: Respiratory rate (RR) is used for the diagnosis and management of medical conditions and can predict clinical changes. Heavy workload, understaffing, and errors related to poor recording make it underutilized. Wearable devices may facilitate its use. METHODS: RR measurements using a wearable photoplethysmography-based monitor were compared with medical grade devices in complementary clinical scenarios: Study one included a comparison to a capnograph in 35 healthy volunteers; Study two included a comparison to a ventilator monitor in 18 ventilated patients; and Study three included a comparison to capnograph in 92 COVID-19 patients with active pulmonary disease. Pearson's correlations and Bland-Altman analysis were used to assess the accuracy and agreement between the measurement techniques, including stratification for Body Mass Index (BMI) and skin tone. Statistical significance was set at p ≤ 0.05. RESULTS: High correlation was found in all studies (r = 0.991, 0.884, and 0.888, respectively, p < 0.001 for all). 95% LOA of ±2.3, 1.7-(-1.6), and ±3.9 with a bias of < 0.1 breaths per minute was found in Bland-Altman analysis in studies 1,2, and 3, respectively. In all, high accordance was found in all sub-groups. CONCLUSIONS: RR measurements using the wearable monitor were highly-correlated with medical-grade devices in various clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT03603860.