Deployment of a wearable biosensor system in the emergency department: a technical feasibility study

Wearable devices to detect changes in health status are increasingly adopted by consumers, yet hospitals remain slow to assimilate these devices into clinical practice. Despite the clear benefits of capturing clinical information in acutely ill patients, such technology remains difficult to implement in emergency medicine. To improve adoption, barriers must first be removed. In our technical feasibility and acceptability trial, we studied the deployment of a wearable wireless biosensor that collects physiological data. We enrolled 44 adult patients receiving care in an emergency department observation unit. After we consented patients for participation, we applied biosensors to their chest and collected basic demographic and clinical information. We then collected biosensor data on an isolated system and measured patient experience via an exit survey. Throughout this process we documented and studied technical challenges. Overall, the technology was feasible to deploy in the emergency department observation unit and was acceptable to participants. Such technologies have tremendous future operational and clinical implications in settings ranging from emergency to home-care

Optimizing Real-Time Wellness Intervention Studies in Healthcare Shift Workers: Outcomes from a Prospective, Single-subject Design Study of a Digital Sleep Aid

Sleep disorders associated with shift work impair alertness and increase risk of chronic physical and mental health disease. Though studying sleep aids in at-risk populations such as shift workers is critical to improving wellness, implementing robust studies to evaluate wellness interventions in live populations can be particularly challenging. We performed a prospective, single-subject design study in which we assessed the effect of noise-masking earbuds on sleep quality, sleepiness, and stress level in health care shift workers. Despite being gifted the technology at the end of the study, we faced poor participant accrual and study retention. Additionally, robust analysis of our intervention’s impact on post-shift alertness was underpowered due to variable participant scheduling. In order to make meaningful advances in improving wellness among such groups, studies emphasizing objective outcome measures while minimizing participant obligation to study protocols are ideal. Here, we discuss our experience studying a digital sleep intervention in a real-time setting and propose solutions for improving subject accrual, retention and methods for objective data collection in studies performed in a live shift worker population

The Feasibility and Acceptability of a Smartphone-Based Music Intervention for Acute Pain

Pain is an unpleasant experience the neurobiology of which is influenced by psychosocial factors including negative affect. Music is a ubiquitous experience that can improve affect, potentially decreasing anxiety and catastrophizing, both of which are associated with greater pain severity. We hypothesized that a machine-learning generative music intervention in the form of a smartphone web app (Unwind) could be used to modulate the experience of pain. In this pilot study, we recruited 15 individuals with acute pain who were admitted to an observation unit in the emergency department, and were being treated with opioids. Participants used the music intervention (Unwind) during this brief hospitalization, after which we assessed their response to its use through a semi- structured qualitative interview. Overall, participants responded positively to Unwind. While some reported some technical challenges, participants were willing to continue using it at home. In particular, participants reported using Unwind to address their anxiety, and many used it to facilitate sleep in the presence of pain. This study demonstrates that individuals with acute pain will accept and use a smartphone-based music protocol

Neighborhood Socioeconomic Status and Use of Colonoscopy in an Insured Population – A Retrospective Cohort Study

Background: Low-socioeconomic status (SES) is associated with a higher colorectal cancer (CRC) incidence and mortality. Screening with colonoscopy, the most commonly used test in the US, has been shown to reduce the risk of death from CRC. This study examined if, among insured persons receiving care in integrated healthcare delivery systems, differences exist in colonoscopy use according to neighborhood SES. Methods We assembled a retrospective cohort of 100,566 men and women, 50–74 years old, who had been enrolled in one of three US health plans for $\geq$ 1 year on January 1, 2000. Subjects were followed until the date of first colonoscopy, date of disenrollment from the health plan, or December 31, 2007, whichever occurred first. We obtained data on colonoscopy use from administrative records. We defined screening colonoscopy as an examination that was not preceded by gastrointestinal conditions in the prior 6-month period. Neighborhood SES was measured using the percentage of households in each subject's census-tract with an income below 1999 federal poverty levels based on 2000 US census data. Analyses, adjusted for demographics and comorbidity index, were performed using Weibull regression models. Results: The average age of the cohort was 60 years and 52.7% were female. During 449,738 person-years of follow-up, fewer subjects in the lowest SES quartile (Q1) compared to the highest quartile (Q4) had any colonoscopy (26.7% vs. 37.1%) or a screening colonoscopy (7.6% vs. 13.3%). In regression analyses, compared to Q4, subjects in Q1 were 16% (adjusted HR = 0.84, 95% CI: 0.80–0.88) less likely to undergo any colonoscopy and 30%(adjusted HR = 0.70, CI: 0.65–0.75) less likely to undergo a screening colonoscopy. Conclusion: People in lower-SES neighborhoods are less likely to undergo a colonoscopy, even among insured subjects receiving care in integrated healthcare systems. Removing health insurance barriers alone is unlikely to eliminate disparities in colonoscopy use

Epidemiological and Immunological Features of Obesity and SARS-CoV-2

Obesity is a key correlate of severe SARS-CoV-2 outcomes while the role of obesity on risk of SARS-CoV-2 infection, symptom phenotype, and immune response remain poorly defined. We examined data from a prospective SARS-CoV-2 cohort study to address these questions. Serostatus, body mass index, demographics, comorbidities, and prior COVID-19 compatible symptoms were assessed at baseline and serostatus and symptoms monthly thereafter. SARS-CoV-2 immunoassays included an IgG ELISA targeting the spike RBD, multiarray Luminex targeting 20 viral antigens, pseudovirus neutralization, and T cell ELISPOT assays. Our results from a large prospective SARS-CoV-2 cohort study indicate symptom phenotype is strongly influenced by obesity among younger but not older age groups; we did not identify evidence to suggest obese individuals are at higher risk of SARS-CoV-2 infection; and remarkably homogenous immune activity across BMI categories suggests immune protection across these groups may be similar

Short Communication: Bioequivalence of Tenofovir Component of Tenofovir/Rilpivirine/Emtricitabine in Digital Pills

Digital pills, gelatin capsules with radiofrequency transmitters activated by stomach chloride ions, directly measure antiretroviral therapy adherence. In individuals with substance use disorders and HIV, real-time nonadherence detected by digital pills creates a platform to deliver substance use and adherence interventions. In this study, we determined the bioequivalence of tenofovir (TFV), administered as tenofovir disoproxil fumarate (TDF) in healthy human volunteers administered a commercial drug product and a digital pill formulation. We adhered generally to the US FDA Analytical Procedures and Methods for Validation for Drugs and Biologics guidelines. Ten HIV-uninfected adults without reported allergy to TFV, emtricitabine, or rilpivirine were enrolled. Participants ingested a digital pill containing TDF/emtricitabine/rilpivirine. Peripheral venous blood samples were collected at 0.5, 1, 2, 4, 8, and 24 h postingestion. After a 14-day washout period, the same participants ingested Complera™. Serial venous blood samples were collected using the same protocol as the digital pill. Liquid chromatography/mass spectrometry was used to determine a maximum concentration (Cmax), area under curve from time zero to last measured concentration (AUCo-t), and area under curve from time zero to infinity (AUCoo) of TFV. Ten participants with an average age of 27 and body mass index of 25.4 successfully completed the study. Predose TFV was undetectable before the second administration of Complera confirming adequate washout period after ingestion of the digital pill. The geometric means of AUCo-t, AUCoo, and Cmax for test and reference products were within the 95% confidence intervals and, therefore, bioequivalent. TFV overencapsulated in digital pills are bioequivalent to TFV in commercial formulations