Performance of and Severe Acute Respiratory Syndrome Coronavirus 2 Diagnostics Based on Symptom Onset and Close Contact Exposure: An Analysis From the Test Us at Home Prospective Cohort Study.

Background: Understanding changes in diagnostic performance after symptom onset and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure within different populations is crucial to guide the use of diagnostics for SARS-CoV-2. Methods: The Test Us at Home study was a longitudinal cohort study that enrolled individuals across the United States between October 2021 and February 2022. Participants performed paired antigen-detection rapid diagnostic tests (Ag-RDTs) and reverse-transcriptase polymerase chain reaction (RT-PCR) tests at home every 48 hours for 15 days and self-reported symptoms and known coronavirus disease 2019 exposures immediately before testing. The percent positivity for Ag-RDTs and RT-PCR tests was calculated each day after symptom onset and exposure and stratified by vaccination status, variant, age category, and sex. Results: The highest percent positivity occurred 2 days after symptom onset (RT-PCR, 91.2%; Ag-RDT, 71.1%) and 6 days after exposure (RT-PCR, 91.8%; Ag-RDT, 86.2%). RT-PCR and Ag-RDT performance did not differ by vaccination status, variant, age category, or sex. The percent positivity for Ag-RDTs was lower among exposed, asymptomatic than among symptomatic individuals (37.5% (95% confidence interval [CI], 13.7%-69.4%) vs 90.3% (75.1%-96.7%). Cumulatively, Ag-RDTs detected 84.9% (95% CI, 78.2%-89.8%) of infections within 4 days of symptom onset. For exposed participants, Ag-RDTs detected 94.0% (95% CI, 86.7%-97.4%) of RT-PCR-confirmed infections within 6 days of exposure. Conclusions: The percent positivity for Ag-RDTs and RT-PCR tests was highest 2 days after symptom onset and 6 days after exposure, and performance increased with serial testing. The percent positivity of Ag-RDTs was lowest among asymptomatic individuals but did not differ by sex, variant, vaccination status, or age category.

Health behavior outcomes in stroke survivors prescribed wearables for atrial fibrillation detection stratified by age.

BACKGROUND: Smartwatches have become readily accessible tools for detecting atrial fibrillation (AF). There remains limited data on how they affect psychosocial outcomes and engagement in older adults. We examine the health behavior outcomes of stroke survivors prescribed smartwatches for AF detection stratified by age. METHODS: We analyzed data from the Pulsewatch study, a randomized controlled trial that enrolled patients (≥ 50 years) with a history of stroke or transient ischemic attack and CHA2DS2-VASc ≥ 2. Intervention participants were equipped with a cardiac patch monitor and a smartwatch-app dyad, while control participants wore the cardiac patch monitor for up to 44 days. We evaluated health behavior parameters using standardized tools, including the Consumer Health Activation Index, the Generalized Anxiety Disorder questionnaire, the 12-Item Short Form Health Survey, and wear time of participants categorized into three age groups: Group 1 (ages 50-60), Group 2 (ages 61-69), and Group 3 (ages 70-87). We performed statistical analysis using a mixed-effects repeated measures linear regression model to examine differences amongst age groups. RESULTS: Comparative analysis between Groups 1, 2 and 3 revealed no significant differences in anxiety, patient activation, perception of physical health and wear time. The use of smartwatch technology was associated with a decrease in perception of mental health for Group 2 compared to Group 1 (ß = -3.29, P = 0.046). CONCLUSION: Stroke survivors demonstrated a willingness to use smartwatches for AF monitoring. Importantly, among these study participants, the majority did not experience negative health behavior outcomes or decreased engagement as age increased.

Technology engagement is associated with higher perceived physical well-being in stroke patients prescribed smartwatches for atrial fibrillation detection.

Background: Increasing ownership of smartphones among Americans provides an opportunity to use these technologies to manage medical conditions. We examine the influence of baseline smartwatch ownership on changes in self-reported anxiety, patient engagement, and health-related quality of life when prescribed smartwatch for AF detection. Method: We performed a post-hoc secondary analysis of the Pulsewatch study (NCT03761394), a clinical trial in which 120 participants were randomized to receive a smartwatch-smartphone app dyad and ECG patch monitor compared to an ECG patch monitor alone to establish the accuracy of the smartwatch-smartphone app dyad for detection of AF. At baseline, 14 days, and 44 days, participants completed the Generalized Anxiety Disorder-7 survey, the Health Survey SF-12, and the Consumer Health Activation Index. Mixed-effects linear regression models using repeated measures with anxiety, patient activation, physical and mental health status as outcomes were used to examine their association with smartwatch ownership at baseline. Results: Ninety-six participants, primarily White with high income and tertiary education, were randomized to receive a study smartwatch-smartphone dyad. Twenty-four (25%) participants previously owned a smartwatch. Compared to those who did not previously own a smartwatch, smartwatch owners reported significant greater increase in their self-reported physical health (ß = 5.07, P < 0.05), no differences in anxiety (ß = 0.92, P = 0.33), mental health (ß = -2.42, P = 0.16), or patient activation (ß = 1.86, P = 0.54). Conclusions: Participants who own a smartwatch at baseline reported a greater positive change in self-reported physical health, but not in anxiety, patient activation, or self-reported mental health over the study period.

Accuracy, Usability, and Adherence of Smartwatches for Atrial Fibrillation Detection in Older Adults After Stroke: Randomized Controlled Trial.

BACKGROUND: Atrial fibrillation (AF) is a common cause of stroke, and timely diagnosis is critical for secondary prevention. Little is known about smartwatches for AF detection among stroke survivors. We aimed to examine accuracy, usability, and adherence to a smartwatch-based AF monitoring system designed by older stroke survivors and their caregivers. OBJECTIVE: This study aims to examine the feasibility of smartwatches for AF detection in older stroke survivors. METHODS: Pulsewatch is a randomized controlled trial (RCT) in which stroke survivors received either a smartwatch-smartphone dyad for AF detection (Pulsewatch system) plus an electrocardiogram patch or the patch alone for 14 days to assess the accuracy and usability of the system (phase 1). Participants were subsequently rerandomized to potentially 30 additional days of system use to examine adherence to watch wear (phase 2). Participants were aged 50 years or older, had survived an ischemic stroke, and had no major contraindications to oral anticoagulants. The accuracy for AF detection was determined by comparing it to cardiologist-overread electrocardiogram patch, and the usability was assessed with the System Usability Scale (SUS). Adherence was operationalized as daily watch wear time over the 30-day monitoring period. RESULTS: A total of 120 participants were enrolled (mean age 65 years; 50/120, 41% female; 106/120, 88% White). The Pulsewatch system demonstrated 92.9% (95% CI 85.3%-97.4%) accuracy for AF detection. Mean usability score was 65 out of 100, and on average, participants wore the watch for 21.2 (SD 8.3) of the 30 days. CONCLUSIONS: Our findings demonstrate that a smartwatch system designed by and for stroke survivors is a viable option for long-term arrhythmia detection among older adults at risk for AF, though it may benefit from strategies to enhance adherence to watch wear. TRIAL REGISTRATION: ClinicalTrials.gov NCT03761394; https://clinicaltrials.gov/study/NCT03761394. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.cvdhj.2021.07.002.

Differential Viral Dynamics by Sex and Body Mass Index During Acute SARS-CoV-2 Infection: Results from a Longitudinal Cohort Study.

BACKGROUND: There is evidence of an association of severe COVID-19 outcomes with increased body mass index (BMI) and male sex. However, few studies have examined the interaction between sex and BMI on SARS-CoV-2 viral dynamics. METHODS: Participants conducted RT-PCR testing every 24-48 hours over a 15-day period. Sex and BMI were self-reported, and Ct values from E-gene were used to quantify viral load. Three distinct outcomes were examined using mixed effects generalized linear models, linear models, and logistic models, respectively: all Ct values (Model 1); nadir Ct value (model 2); and strongly detectable infection (at least one Ct value ≤28 during their infection) (Model 3). An interaction term between BMI and sex was included, and inverse logit transformations were applied to quantify the differences by BMI and sex using marginal predictions. RESULTS: In total, 7,988 participants enrolled in this study, and 439 participants (Model 1) and 309 (Model 2 and 3) were eligible for these analyses. Among males, increasing BMI was associated with lower Ct values in a dose-response fashion. For participants with BMIs greater than 29, males had significantly lower Ct values and nadir Ct values than females. In total, 67.8% of males and 55.3% of females recorded a strongly detectable infection; increasing proportions of men had Ct values <28 with BMIs of 35 and 40. CONCLUSIONS: We observed sex-based dimorphism in relation to BMI and COVID-19 viral load. Further investigation is needed to determine the cause, clinical impact, and transmission implications of this sex-differential effect of BMI on viral load.

Anxiety, patient activation, and quality of life among stroke survivors prescribed smartwatches for atrial fibrillation monitoring.

Background: The detection of atrial fibrillation (AF) in stroke survivors is critical to decreasing the risk of recurrent stroke. Smartwatches have emerged as a convenient and accurate means of AF diagnosis; however, the impact on critical patient-reported outcomes, including anxiety, engagement, and quality of life, remains ill defined. Objectives: To examine the association between smartwatch prescription for AF detection and the patient-reported outcomes of anxiety, patient activation, and self-reported health. Methods: We used data from the Pulsewatch trial, a 2-phase randomized controlled trial that included participants aged 50 years or older with a history of ischemic stroke. Participants were randomized to use either a proprietary smartphone-smartwatch app for 30 days of AF monitoring or no cardiac rhythm monitoring. Validated surveys were deployed before and after the 30-day study period to assess anxiety, patient activation, and self-rated physical and mental health. Logistic regression and generalized estimation equations were used to examine the association between smartwatch prescription for AF monitoring and changes in the patient-reported outcomes. Results: A total of 110 participants (mean age 64 years, 41% female, 91% non-Hispanic White) were studied. Seventy percent of intervention participants were novice smartwatch users, as opposed to 84% of controls, and there was no significant difference in baseline rates of anxiety, activation, or self-rated health between the 2 groups. The incidence of new AF among smartwatch users was 6%. Participants who were prescribed smartwatches did not have a statistically significant change in anxiety, activation, or self-reported health as compared to those who were not prescribed smartwatches. The results held even after removing participants who received an AF alert on the watch. Conclusion: The prescription of smartwatches to stroke survivors for AF monitoring does not adversely affect key patient-reported outcomes. Further research is needed to better inform the successful deployment of smartwatches in clinical practice.

False Atrial Fibrillation Alerts from Smartwatches are Associated with Decreased Perceived Physical Well-being and Confidence in Chronic Symptoms Management.

Wrist-based wearables have been FDA approved for AF detection. However, the health behavior impact of false AF alerts from wearables on older patients at high risk for AF are not known. In this work, we analyzed data from the Pulsewatch (NCT03761394) study, which randomized patients (≥50 years) with history of stroke or transient ischemic attack to wear a patch monitor and a smartwatch linked to a smartphone running the Pulsewatch application vs to only the cardiac patch monitor over 14 days. At baseline and 14 days, participants completed validated instruments to assess for anxiety, patient activation, perceived mental and physical health, chronic symptom management self-efficacy, and medicine adherence. We employed linear regression to examine associations between false AF alerts with change in patient-reported outcomes. Receipt of false AF alerts was related to a dose-dependent decline in self-perceived physical health and levels of disease self-management. We developed a novel convolutional denoising autoencoder (CDA) to remove motion and noise artifacts in photoplethysmography (PPG) segments to optimize AF detection, which substantially reduced the number of false alerts. A promising approach to avoid negative impact of false alerts is to employ artificial intelligence driven algorithms to improve accuracy.

Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection : A Prospective Cohort Study.

BACKGROUND: The performance of rapid antigen tests (Ag-RDTs) for screening asymptomatic and symptomatic persons for SARS-CoV-2 is not well established. OBJECTIVE: To evaluate the performance of Ag-RDTs for detection of SARS-CoV-2 among symptomatic and asymptomatic participants. DESIGN: This prospective cohort study enrolled participants between October 2021 and January 2022. Participants completed Ag-RDTs and reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 every 48 hours for 15 days. SETTING: Participants were enrolled digitally throughout the mainland United States. They self-collected anterior nasal swabs for Ag-RDTs and RT-PCR testing. Nasal swabs for RT-PCR were shipped to a central laboratory, whereas Ag-RDTs were done at home. PARTICIPANTS: Of 7361 participants in the study, 5353 who were asymptomatic and negative for SARS-CoV-2 on study day 1 were eligible. In total, 154 participants had at least 1 positive RT-PCR result. MEASUREMENTS: The sensitivity of Ag-RDTs was measured on the basis of testing once (same-day), twice (after 48 hours), and thrice (after a total of 96 hours). The analysis was repeated for different days past index PCR positivity (DPIPPs) to approximate real-world scenarios where testing initiation may not always coincide with DPIPP 0. Results were stratified by symptom status. RESULTS: Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDTs twice 48 hours apart resulted in an aggregated sensitivity of 93.4% (95% CI, 90.4% to 95.9%) among symptomatic participants on DPIPPs 0 to 6. When singleton positive results were excluded, the aggregated sensitivity on DPIPPs 0 to 6 for 2-time serial testing among asymptomatic participants was lower at 62.7% (CI, 57.0% to 70.5%), but it improved to 79.0% (CI, 70.1% to 87.4%) with testing 3 times at 48-hour intervals. LIMITATION: Participants tested every 48 hours; therefore, these data cannot support conclusions about serial testing intervals shorter than 48 hours. CONCLUSION: The performance of Ag-RDTs was optimized when asymptomatic participants tested 3 times at 48-hour intervals and when symptomatic participants tested 2 times separated by 48 hours. PRIMARY FUNDING SOURCE: National Institutes of Health RADx Tech program.

Bilateral Ovarian Serous Borderline Tumor with Non-Invasive Endometrial Implants.

Herein, we are presenting a case of a 33-year-old woman who presented to the emergency department complaining of persistent lower abdominal pain of one-day duration. Physical examination revealed abdominal tenderness with right lower quadrant rebound tenderness. Computed tomography abdomen/pelvis showed a 6 cm possible necrotic mass of the left ovary with moderate amount of complex ascites. A laparoscopic left oophorectomy with bilateral salpingectomy, right ovarian biopsy, and appendectomy were performed without complications. The cut surface of the left ovary showed a 9.7 cm × 8 cm × 4 cm ovarian mass, and the cut surface revealed multiple gray-tan friable papillary excrescence. Microscopic evaluation showed findings consistent with left and right ovarian serous borderline tumor (SBT). Subsequently, a tumor staging was conducted with total laparoscopic hysterectomy, pelvic and periaortic lymph node dissection, and omentectomy. The endometrium sections showed several small foci of SBT within the endometrial stroma, consistent with non-invasive implants of the endometrium. The omentum and lymph nodes were all negative for malignancy. SBTs associated with endometrial implants are very rare with only one case reported in the literature. Their existence can cause diagnostic challenges, and they should be acknowledged for early diagnosis and to plan for patient's treatment and outcome.

Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection.

Background: Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals. Methods: This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported. Key Results: A total of 7361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Conclusions: The digital site-less approach employed in the "Test Us At Home" study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19 and can be adapted across research disciplines to optimize study enrollment and accessibility.

Performance of Rapid Antigen Tests Based on Symptom Onset and Close Contact Exposure: A secondary analysis from the Test Us At Home prospective cohort study.

Background: The performance of rapid antigen tests for SARS-CoV-2 (Ag-RDT) in temporal relation to symptom onset or exposure is unknown, as is the impact of vaccination on this relationship. Objective: To evaluate the performance of Ag-RDT compared with RT-PCR based on day after symptom onset or exposure in order to decide on 'when to test'. Design Setting and Participants: The Test Us at Home study was a longitudinal cohort study that enrolled participants over 2 years old across the United States between October 18, 2021 and February 4, 2022. All participants were asked to conduct Ag-RDT and RT-PCR testing every 48 hours over a 15-day period. Participants with one or more symptoms during the study period were included in the Day Post Symptom Onset (DPSO) analyses, while those who reported a COVID-19 exposure were included in the Day Post Exposure (DPE) analysis. Exposure: Participants were asked to self-report any symptoms or known exposures to SARS-CoV-2 every 48-hours, immediately prior to conducting Ag-RDT and RT-PCR testing. The first day a participant reported one or more symptoms was termed DPSO 0, and the day of exposure was DPE 0. Vaccination status was self-reported. Main Outcome and Measures: Results of Ag-RDT were self-reported (positive, negative, or invalid) and RT-PCR results were analyzed by a central laboratory. Percent positivity of SARS-CoV-2 and sensitivity of Ag-RDT and RT-PCR by DPSO and DPE were stratified by vaccination status and calculated with 95% confidence intervals. Results: A total of 7,361 participants enrolled in the study. Among them, 2,086 (28.3%) and 546 (7.4%) participants were eligible for the DPSO and DPE analyses, respectively. Unvaccinated participants were nearly twice as likely to test positive for SARS-CoV-2 than vaccinated participants in event of symptoms (PCR+: 27.6% vs 10.1%) or exposure (PCR+: 43.8% vs. 22.2%). The highest proportion of vaccinated and unvaccinated individuals tested positive on DPSO 2 and DPE 5-8. Performance of RT-PCR and Ag-RDT did not differ by vaccination status. Ag-RDT detected 78.0% (95% Confidence Interval: 72.56-82.61) of PCR-confirmed infections by DPSO 4. For exposed participants, Ag-RDT detected 84.9% (95% CI: 75.0-91.4) of PCR-confirmed infections by day five post-exposure (DPE 5). Conclusions and Relevance: Performance of Ag-RDT and RT-PCR was highest on DPSO 0-2 and DPE 5 and did not differ by vaccination status. These data suggests that serial testing remains integral to enhancing the performance of Ag-RDT.

Self-reported efficacy in patient-physician interaction in relation to anxiety, patient activation, and health-related quality of life among stroke survivors.

BACKGROUND: Early detection of AF is critical for stroke prevention. Several commercially available smartwatches are FDA cleared for AF detection. However, little is known about how patient-physician relationships affect patients' anxiety, activation, and health-related quality of life when prescribed smartwatch for AF detection. METHODS: Data were used from the Pulsewatch study (NCT03761394), which randomized adults (>50 years) with no contraindication to anticoagulation and a CHA2DS2-VASc risk score ≥2 to receive a smartwatch-smartphone app dyad for AF monitoring vs. conventional monitoring with an ECG patch (Cardea SoloTM) and monitored participants for up to 45 days. The Perceived Efficacy in Patient-Physician Interactions survey was used to assess patient confidence in physician interaction at baseline with scores ≥45 indicating high perceived efficacy in patient-provider interactions. Generalized Anxiety Disorder-7 Scale, Consumer Health Activation Index, and Short-Form Health Survey were utilized to examine anxiety, patient activation, and physical and mental health status, at baseline, 14, and 44 days, respectively. We used mixed-effects repeated measures linear regression models to assess changes in psychosocial outcomes among smartwatch users in relation to self-reported efficacy in physician interaction over the study period. RESULTS: A total of 93 participants (average age 64.1 ± 8.9 years; 43.0% female; 88.2% non-Hispanic white) were included in this analysis. At baseline, fifty-six (60%) participants reported high perceived efficacy in patient-physician interaction. In the fully adjusted models, high perceived efficacy (vs. low) at baseline was associated with greater patient activation and perceived mental health (ß 12.0, p-value <0.001; ß 3.39, p-value <0.05, respectively). High perceived self-efficacy was not associated with anxiety or physical health status (ß - 0.61, p-value 0.46; ß 0.64, p-value 0.77) among study participants. CONCLUSIONS: Higher self-efficacy in patient-physician interaction was associated with higher patient activation and mental health status among stroke survivors using smartwatches. Furthermore, we found no association between anxiety and smartwatch prescription for AF in participants with high self-efficacy in patient-physician interaction. Efforts to improve self-efficacy in patient-physician interaction may improve patient activation and self-rated health and subsequently may lead to better clinical outcomes.KEY MESSAGESHigher self-efficacy in patient-physician interaction was associated with higher patient activation and mental health status among stroke survivors using smartwatches.No association between anxiety and smartwatch prescription for AF in participants with high self-efficacy in patient-physician interaction.Efforts to improve self-efficacy in patient-physician interaction may improve patient activation and self-rated health and subsequently may lead to better clinical outcomes.

Emphysematous pancreatitis with pulmonary embolism: A case report.

Background: Emphysematous pancreatitis is a severe systemic inflammatory process with reports of pulmonary embolism in the setting of acute pancreatitis rarely described. Case presentation: A 61-year-old woman presented with severe abdominal pain of 1 day duration. She was found to have acute interstitial pancreatitis. During her hospitalization, the patient developed worsening abdominal pain associated with increasing oxygen demands, requiring supplemental oxygen through nasal cannula. Workup showed pulmonary embolism in the posterior segmental branch of the left lower lobar artery and development of emphysematous pancreatitis was noted on imaging. The patient was started on intravenous antibiotics and therapeutic anticoagulation; her condition improved and was discharged home. Conclusion: Patients with severe acute pancreatitis may be at risk for pulmonary embolism due to immobilization and other inflammatory mechanisms. Mitigating individualized risk factors and anticoagulation use as prophylaxis should be considered in patients with pancreatitis to prevent embolism. Early detection by clinicians is critical to reduce misdiagnosis and mortality rates.

Finding a Needle in a Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection.

Background: Rapid antigen tests (Ag-RDT) for SARS-CoV-2 with Emergency Use Authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. Objective: To describe a novel study design to generate regulatory-quality data to evaluate serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals. Design: Prospective cohort study using a decentralized approach. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Setting: Participants throughout the mainland United States were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Ag-RDTs were completed at home, and molecular comparators were shipped to a central laboratory. Participants: Individuals over 2 years old from across the U.S. with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Measurements: Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported. Key Results: A total of 7,361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 U.S. states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Limitations: New, complex workflows required significant operational and data team support. Conclusions: The digital site-less approach employed in the 'Test Us At Home' study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19, and can be adapted across research disciplines to optimize study enrollment and accessibility.

Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection.

Background: Performance of rapid antigen tests for SARS-CoV-2 (Ag-RDT) varies over the course of an infection, and their performance in screening for SARS-CoV-2 is not well established. We aimed to evaluate performance of Ag-RDT for detection of SARS-CoV-2 for symptomatic and asymptomatic participants. Methods: Participants >2 years old across the United States enrolled in the study between October 2021 and February 2022. Participants completed Ag-RDT and molecular testing (RT-PCR) for SARS-CoV-2 every 48 hours for 15 days. This analysis was limited to participants who were asymptomatic and tested negative on their first day of study participation. Onset of infection was defined as the day of first positive RT-PCR result. Sensitivity of Ag-RDT was measured based on testing once, twice (after 48-hours), and thrice (after 96 hours). Analysis was repeated for different Days Post Index PCR Positivity (DPIPP) and stratified based on symptom-status. Results: In total, 5,609 of 7,361 participants were eligible for this analysis. Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDT twice 48-hours apart resulted in an aggregated sensitivity of 93.4% (95% CI: 89.1-96.1%) among symptomatic participants on DPIPP 0-6. Excluding singleton positives, aggregated sensitivity on DPIPP 0-6 for two-time serial-testing among asymptomatic participants was lower at 62.7% (54.7-70.0%) but improved to 79.0% (71.0-85.3%) with testing three times at 48-hour intervals. Discussion: Performance of Ag-RDT was optimized when asymptomatic participants tested three-times at 48-hour intervals and when symptomatic participants tested two-times separated by 48-hours.

Pharmacotherapy of type 2 diabetes: An update and future directions.

Type 2 diabetes (T2D) is a widely prevalent disease with substantial economic and social impact for which multiple conventional and novel pharmacotherapies are currently available; however, the landscape of T2D treatment is constantly changing as new therapies emerge and the understanding of currently available agents deepens. This review aims to provide an updated summary of the pharmacotherapeutic approach to T2D. Each class of agents is presented by mechanism of action, details of administration, side effect profile, cost, and use in certain populations including heart failure, non-alcoholic fatty liver disease, obesity, chronic kidney disease, and older individuals. We also review targets of novel therapeutic T2D agent development. Finally, we outline an up-to-date treatment approach that starts with identification of an individualized goal for glycemic control then selection, initiation, and further intensification of a personalized therapeutic plan for T2D.

Comparison of Rapid Antigen Tests' Performance Between Delta and Omicron Variants of SARS-CoV-2 : A Secondary Analysis From a Serial Home Self-testing Study.

BACKGROUND: It is important to document the performance of rapid antigen tests (Ag-RDTs) in detecting SARS-CoV-2 variants. OBJECTIVE: To compare the performance of Ag-RDTs in detecting the Delta (B.1.617.2) and Omicron (B.1.1.529) variants of SARS-CoV-2. DESIGN: Secondary analysis of a prospective cohort study that enrolled participants between 18 October 2021 and 24 January 2022. Participants did Ag-RDTs and collected samples for reverse transcriptase polymerase chain reaction (RT-PCR) testing every 48 hours for 15 days. SETTING: The parent study enrolled participants throughout the mainland United States through a digital platform. All participants self-collected anterior nasal swabs for rapid antigen testing and RT-PCR testing. All Ag-RDTs were completed at home, whereas nasal swabs for RT-PCR were shipped to a central laboratory. PARTICIPANTS: Of 7349 participants enrolled in the parent study, 5779 asymptomatic persons who tested negative for SARS-CoV-2 on day 1 of the study were eligible for this substudy. MEASUREMENTS: Sensitivity of Ag-RDTs on the same day as the first positive (index) RT-PCR result and 48 hours after the first positive RT-PCR result. RESULTS: A total of 207 participants were positive on RT-PCR (58 Delta, 149 Omicron). Differences in sensitivity between variants were not statistically significant (same day: Delta, 15.5% [95% CI, 6.2% to 24.8%] vs. Omicron, 22.1% [CI, 15.5% to 28.8%]; at 48 hours: Delta, 44.8% [CI, 32.0% to 57.6%] vs. Omicron, 49.7% [CI, 41.6% to 57.6%]). Among 109 participants who had RT-PCR-positive results for 48 hours, rapid antigen sensitivity did not differ significantly between Delta- and Omicron-infected participants (48-hour sensitivity: Delta, 81.5% [CI, 66.8% to 96.1%] vs. Omicron, 78.0% [CI, 69.1% to 87.0%]). Only 7.2% of the 69 participants with RT-PCR-positive results for shorter than 48 hours tested positive by Ag-RDT within 1 week; those with Delta infections remained consistently negative on Ag-RDTs. LIMITATION: A testing frequency of 48 hours does not allow a finer temporal resolution of the analysis of test performance, and the results of Ag-RDTs are based on self-report. CONCLUSION: The performance of Ag-RDTs in persons infected with the SARS-CoV-2 Omicron variant is not inferior to that in persons with Delta infections. Serial testing improved the sensitivity of Ag-RDTs for both variants. The performance of rapid antigen testing varies on the basis of duration of RT-PCR positivity. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute of the National Institutes of Health.

Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry.

BACKGROUND: Lead dislodgement (LD) has been one of the most common early complications after cardiovascular implantable electronic device implant. However, limited data are available on the clinical characteristics and long-term outcomes of LD events. The aim of this study was to examine the risk factors, clinical significance, and management strategies of LD events after cardiovascular implantable electronic device implant. METHODS: This study was a retrospective cohort analysis of 20 683 patients who underwent cardiovascular implantable electronic device implant between January 1, 2010 and January 31, 2020 in Medtronic's Product Surveillance Registry, with a mean follow-up time of 3.3±2.5 SD years. The study population was divided into 2 groups: group A with LD events (N=350) and group B without LD events (N=20 333). RESULTS: During this period, 350 patients (1.69%) had LD events involving 371 leads (0.95%), among a total of 39 060 leads implanted. Passive fixation type (right atrium pacing lead, P=0.041), lower sensing amplitude (right ventricle defibrillating lead, P=0.020), and lower lead impedance at implant (right atrium pacing lead, P=0.009) were associated with increased LD risk. Multivariate analysis showed female sex (hazard ratio, 1.520, P=0.008) and higher body mass index (hazard ratio, 1.012, P=0.001) were independently associated with increased risk of LD events. LD events were not associated with significant changes in the long-term risks of cardiac and overall mortality. In group A, repositioning the dislodged leads increased the risk of a second LD event compared with implanting new leads (P=0.012). CONCLUSIONS: Female sex and higher body mass index were associated with higher risk of LD events in the Product Surveillance Registry. Among patients with dislodged leads, implanting new leads was associated with lower risk of future LD events. Further studies on how to reduce LD risk and to improve management of these events are needed. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01524276.

Age and Sex Differences and Temporal Trends in the Use of Invasive and Noninvasive Procedures in Patients Hospitalized With Acute Myocardial Infarction.

Background Few studies have examined age and sex differences in the receipt of cardiac diagnostic and interventional procedures in patients hospitalized with acute myocardial infarction and trends in these possible differences during recent years. Methods and Results Data from patients hospitalized with a first acute myocardial infarction at the major medical centers in the Worcester, Massachusetts, metropolitan area were utilized for this study. Logistic regression analysis was used to examine age (<55, 55-64, 65-74, and ≥75 years) and sex differences in the receipt of echocardiography, exercise stress testing, coronary angiography, percutaneous coronary interventions, and coronary artery bypass graft surgery, and trends in the use of those procedures during patients' acute hospitalization, between 2005 and 2018, while adjusting for important confounding factors. The study population consisted of 1681 men and 1154 women with an initial acute myocardial infarction who were hospitalized on an approximate biennial basis between 2005 and 2018. A smaller proportion of women underwent cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass graft surgery, while there were no sex differences in the receipt of echocardiography and exercise stress testing. Patients aged ≥75 years were less likely to undergo cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass graft surgery, but were more likely to receive echocardiography compared with younger patients. Between 2005 and 2018, the use of echocardiography and coronary artery bypass graft surgery nonsignificantly increased among all age groups and both sexes, while the use of cardiac catheterization and percutaneous coronary intervention increased nonsignificantly faster in women and older patients. Conclusions We observed a continued lower receipt of invasive cardiac procedures in women and patients aged ≥75 years with acute myocardial infarction, but age and sex gaps associated with these procedures have narrowed during recent years.