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BackgroundThe US Preventive Services Task Force recommends providers offer individualized healthy behavior interventions for all adults, independent of their risk of cardiovascular disease. While strong evidence exists to support disease-specific programs designed to improve multiple lifestyle behaviors, approaches to adapting these interventions for a broader population are not well established. Digital behavior change interventions (DBCIs) hold promise as a more generalizable and scalable approach to overcome the resource and time limitations that traditional behavioral intervention programs face, especially within an occupational setting. ObjectiveWe aimed to evaluate the efficacy of a multimodal DBCI on (1) self-reported behaviors of physical activity, nutrition, sleep, and mindfulness; (2) cardiometabolic biomarkers; and (3) chronic disease–related medical expenditure. MethodsWe conducted a 2-arm randomized controlled trial for 12 months among employees of an academic health care facility in the United States. The intervention arm received a scale, a smartphone app, an activity tracker, a video library for healthy behavior recommendations, and an on-demand health coach. The control arm received standard employer-provided health and wellness benefits. The primary outcomes of the study included changes in self-reported lifestyle behaviors, cardiometabolic biomarkers, and chronic disease–related medical expenditure. We collected health behavior data via baseline and quarterly web-based surveys, biometric measures via clinic visits at baseline and 12 months, and identified relevant costs through claims datasets. ResultsA total of 603 participants were enrolled and randomized to the intervention (n=300, 49.8%) and control arms (n=303, 50.2%). The average age was 46.7 (SD 11.2) years, and the majority of participants were female (80.3%, n=484), White (85.4%, n=504), and non-Hispanic (90.7%, n=547), with no systematic differences in baseline characteristics observed between the study arms. We observed retention rates of 86.1% (n=519) for completing the final survey and 77.9% (n=490) for attending the exit visit. ConclusionsThis study represents the largest and most comprehensive evaluation of DBCIs among participants who were not selected based on their underlying condition to assess its impact on behavior, cardiometabolic biomarkers, and medical expenditure. Trial RegistrationClinicalTrials.gov NCT04712383; https://clinicaltrials.gov/study/NCT04712383 International Registered Report Identifier (IRRID)RR1-10.2196/50378

Background Hypertension is an important modifiable risk factor of serious maternal morbidity and mortality. Social determinants of health (SDoH) influence hypertension outcomes and may contribute to racial and ethnic differences in hypertension control. Our objective was to assess SDoH and blood pressure (BP) control by race and ethnicity in US women of childbearing age with hypertension. Methods and Results We studied women (aged 20–50 years) with hypertension (systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg or use of antihypertensive medication) in the National Health and Nutrition Examination Surveys 2001 to 2018. SDoH and BP control (systolic BP

Abstract 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.

BackgroundThe ongoing SARS-CoV-2 pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb disease transmission, morbidity, and mortality. Rapid antigen tests are important tools for scaling up testing for SARS-CoV-2; however, little is known about individuals’ use of rapid antigen tests at home and how to facilitate the user experience. ObjectiveThis study aimed to describe the feasibility and acceptability of serial self-testing with rapid antigen tests for SARS-CoV-2, including need for assistance and the reliability of self-interpretation. MethodsA total of 206 adults in the United States with smartphones were enrolled in this single-arm feasibility study in February and March 2021. All participants were asked to self-test for COVID-19 at home using rapid antigen tests daily for 14 days and use a smartphone app for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, the acceptability of testing and smartphone app experiences, and the reliability of participants versus study team’s interpretation of test results. Descriptive statistics were used to report the acceptability, adherence, overall rating, and experience of using the at-home test and MyDataHelps app. The usability, acceptability, adherence, and quality of at-home testing were analyzed across different sociodemographic, age, and educational attainment groups. ResultsOf the 206 enrolled participants, 189 (91.7%) and 159 (77.2%) completed testing and follow-up surveys, respectively. In total, 51.3% (97/189) of study participants were women, the average age was 40.7 years, 34.4% (65/189) were non-White, and 82% (155/189) had a bachelor’s degree or higher. Most (n=133/206, 64.6%) participants showed high testing adherence, meaning they completed over 75% of the assigned tests. Participants’ interpretations of test results demonstrated high agreement (2106/2130, 98.9%) with the study verified results, with a κ score of 0.29 (P

The incidence of Neonatal Abstinence Syndrome (NAS) continues to rise and there remains a critical need to develop non-pharmacological interventions for managing opioid withdrawal in newborns. Objective physiologic markers of opioid withdrawal in the newborn remain elusive. Optimal treatment strategies for improving short-term clinical outcomes and promoting healthy neurobehavioral development have yet to be defined. This dual-site randomized controlled trial (NCT02801331) is designed to evaluate the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological treatment, and length of hospitalization, and for improving developmental outcomes in opioid-exposed neonates. Hospitalized newborns (n = 230) receiving standard clinical care for prenatal opioid exposure will be randomly assigned within 48-hours of birth to a crib with either: 1) Intervention (SVS) mattress: specially-constructed SVS crib mattress that delivers gentle vibrations (30–60 Hz, ~12 μm RMS surface displacement) at 3-hr intervals; or 2) Control mattress (treatment as usual; TAU): non-oscillating hospital-crib mattress. Infants will be studied throughout their hospitalization and post discharge to 14-months of age. The study will compare clinical measures (i.e., withdrawal scores, cumulative dose and duration of medications, velocity of weight gain) and characteristic progression of physiologic activity (i.e., limb movement, cardio-respiratory, temperature, blood-oxygenation) throughout hospitalization between opioid-exposed infants who receive SVS and those who receive TAU. Developmental outcomes (i.e., physical, social, emotional and cognitive) within the first year of life will be evaluated between the two study groups. Findings from this randomized controlled trial will determine whether SVS reduces in-hospital severity of NAS, improves physiologic function, and promotes healthy development.

Abstract Background Acute Care Surgery (ACS) was developed as a structured, team-based approach to providing round-the-clock emergency general surgery (EGS) care for adult patients needing treatment for diseases such as cholecystitis, gastrointestinal perforation, and necrotizing fasciitis. Lacking any prior evidence on optimizing outcomes for EGS patients, current implementation of ACS models has been idiosyncratic. We sought to use a Donabedian approach to elucidate potential EGS structures and processes that might be associated with improved outcomes as an initial step in designing the optimal model of ACS care for EGS patients. Methods We developed and implemented a national survey of hospital-level EGS structures and processes by surveying surgeons or chief medical officers regarding hospital-level structures and processes that directly or indirectly impacted EGS care delivery in 2015. These responses were then anonymously linked to 2015 data from the American Hospital Association (AHA) annual survey, Medicare Provider Analysis and Review claims (MedPAR), 17 State Inpatient Databases (SIDs) using AHA unique identifiers (AHAID). This allowed us to combine hospital-level data, as reported in our survey or to the AHA, to patient-level data in an effort to further examine the role of EGS structures and processes on EGS outcomes. We describe the multi-step, iterative process utilizing the Donabedian framework for quality measurement that serves as a foundation for later work in this project. Results Hospitals that responded to the survey were primarily non-governmental and located in urban settings. A plurality of respondent hospitals had fewer than 100 inpatient beds. A minority of the hospitals had medical school affiliations. Discussion Our results will enable us to develop a measure of preparedness for delivering EGS care in the US, provide guidance for regionalized care models for EGS care, tiering of ACS programs based on the robustness of their EGS structures and processes and the quality of their outcomes, and formulate triage guidelines based on patient risk factors and severity of EGS disease. Conclusions Our work provides a template for team science applicable to research efforts combining primary data collection (i.e., that derived from our survey) with existing national data sources (i.e., SIDs and MedPAR).

Introduction:. Despite 3 million adults in the United States being admitted annually for emergency general surgery (EGS) conditions, which disproportionately affect vulnerable populations, we lack an understanding of the barriers to round-the-clock EGS care. Our objective was to measure gaps in round-the-clock EGS care. Methods:. From August 2015 to December 2015, we surveyed all US-based adult acute care general hospitals that have an emergency room and ≥1 operating room and provided EGS care, utilizing paper and electronic methods. Surgeons or chief medical officers were queried regarding EGS practices. Results:. Of 2811 hospitals, 1634 (58.1%) responded; 279 (17.1%) were unable to always provide round-the-clock EGS care. Rural location, smaller bed size, and nonteaching status were associated with lack of round-the-clock care. Inconsistent surgeon coverage was the primary reason for lacking round-the-clock EGS care (n = 162; 58.1%). However, lack of a tiered system for booking emergency cases, no anesthesia availability overnight, and no stipend for EGS call were also associated with the inability to provide round-the-clock EGS care. Discussion:. We found significant gaps in access to EGS care, often attributable to workforce deficiencies.