Wearable Sensor-Based Detection of Influenza in Presymptomatic and Asymptomatic Individuals.

Background: The COVID-19 pandemic highlighted the need for early detection of viral infections in symptomatic and asymptomatic individuals to allow for timely clinical management and public health interventions.

Methods: Twenty healthy adults were challenged with an influenza A (H3N2) virus and prospectively monitored from 7 days before through 10 days after inoculation, using wearable electrocardiogram and physical activity sensors. This framework allowed for responses to be accurately referenced to the infection event.

Supporting informed clinical trial decisions: Results from a randomized controlled trial evaluating a digital decision support tool for those with intellectual disability.

Background: Informed consent requires that individuals understand the nature of the study, risks and benefits of participation. Individuals with intellectual disabilities (ID) have cognitive and adaptive impairments that may affect their ability to provide informed consent. New treatments and clinical trials for fragile X syndrome, the most commonly known inherited cause of ID, necessitate the development of methods to improve the informed consent process.

Implementing Web-Based Interventions in HIV Primary Care Clinics: Pilot Implementation Evaluation of Positive Health Check.

Background: Web-based interventions can help people living with HIV achieve better clinical outcomes and behaviors, but integrating them into clinical practice remains challenging. There is a gap in understanding the feasibility of implementing these interventions in HIV clinic settings from the clinicians' perspective.

Objective: The goal of the research was to determine whether Positive Health Check (PHC)-a Web-based, tailored video counseling tool focused on increasing patient adherence and retention in care and reducing HIV risk among HIV-positive patients-was acceptable, appropriate, and feasible for HIV primary care clinic staff to implement in clinic workflows.

Exposure to Potentially Harmful E-Cigarette Emissions via Vape Tricks: Protocol for a Mixed-Methods Study.

Background: The number of adolescents and adults using e-cigarettes, referred to as vaping, has dramatically increased. E-cigarettes can be used to perform vape tricks by inhaling and exhaling the e-cigarette aerosol in patterns to create visual effects or large clouds. To create these effects, the puffing patterns associated with vape tricks may be different than standard ad-lib e-cigarette usage.

Consumer-Mediated Data Exchange for Research: Current State of US Law, Technology, and Trust.

A compendium of US laws and regulations offers increasingly strong support for the concept that researchers can acquire the electronic health record data that their studies need directly from the study participants using technologies and processes called consumer-mediated data exchange. This data acquisition method is particularly valuable for studies that need complete longitudinal electronic records for all their study participants who individually and collectively receive care from multiple providers in the United States. In such studies, it is logistically infeasible for the researcher to receive necessary data directly from each provider, including providers who may not have the capability, capacity, or interest in supporting research.

Establishing Digital Biomarkers for Occupational Health Assessment in Commercial Salmon Fishermen: Protocol for a Mixed-Methods Study.

Background: Commercial salmon fishing in Alaska is one of the most dangerous occupations in the United States. Between 1992 and 2008, the average annual industry mortality rate was 128 deaths per 100,000 workers, and despite an increase in industry regulations, there has not been a significant decrease in mortality rate since 2000. Unpredictable fishing openings and fierce competition for limited resources result in periods of intense sleep deprivation and physical strain during the short commercial salmon season in Alaska.

A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial.

Background: Any study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants' decisional capacity.

A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.

Background: Challenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial.

Objective: We describe the design and development process of a tablet-based decision support tool.

Establishing Linkages Between Distributed Survey Responses and Consumer Wearable Device Datasets: A Pilot Protocol.

Background: As technology increasingly becomes an integral part of everyday life, many individuals are choosing to use wearable technology such as activity trackers to monitor their daily physical activity and other health-related goals. Researchers would benefit from learning more about the health of these individuals remotely, without meeting face-to-face with participants and avoiding the high cost of providing consumer wearables to participants for the study duration.

Objective: The present study seeks to develop the methods to collect data remotely and establish a linkage between self-reported survey responses and consumer wearable device biometric data, ultimately producing a de-identified and linked dataset.

Biometrics and Policing: A Protocol for Multichannel Sensor Data Collection and Exploratory Analysis of Contextualized Psychophysiological Response During Law Enforcement Operations.

Background: Stress experienced by law enforcement officers is often extreme and is in many ways unique among professions. Although past research on officer stress is informative, it is limited, and most studies measure stress using self-report questionnaires or observational studies that have limited generalizability. We know of no research studies that have attempted to track direct physiological stress responses in high fidelity, especially within an operational police setting.

A Mobile Clinical Decision Support Tool for Pediatric Cardiovascular Risk-Reduction Clinical Practice Guidelines: Development and Description.

Background: Widespread application of research findings to improve patient outcomes remains inadequate, and failure to routinely translate research findings into daily clinical practice is a major barrier for the implementation of any evidence-based guideline. Strategies to increase guideline uptake in primary care pediatric practices and to facilitate adherence to recommendations are required.

Objective: Our objective was to operationalize the US National Heart, Lung, and Blood Institute's Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents into a mobile clinical decision support (CDS) system for healthcare providers, and to describe the process development and outcomes.

ActiviTeen: A Protocol for Deployment of a Consumer Wearable Device in an Academic Setting.

Background: Regular physical activity (PA) can be an important indicator of health across an individual's life span. Consumer wearables, such as Fitbit or Jawbone, are becoming increasingly popular to track PA. With the increased adoption of activity trackers comes the increased generation of valuable individual-based data.

Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

Background: Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research.

Objective: Develop three protocols to support tablet configuration, tablet management, and tablet maintenance.

Usability Testing and Adaptation of the Pediatric Cardiovascular Risk Reduction Clinical Decision Support Tool.

Background: Cardiovascular disease (CVD) is 1 of the leading causes of death, years of life lost, and disability-adjusted years of life lost worldwide. CVD prevention for children and teens is needed, as CVD risk factors and behaviors beginning in youth contribute to CVD development. In 2012, the National Heart, Lung, and Blood Institute released their "Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents" for clinicians, describing CVD risk factors they should address with patients at primary care preventative visits.

Supporting Parental Decisions About Genomic Sequencing for Newborn Screening: The NC NEXUS Decision Aid.

Advances in genomic sequencing technology have raised fundamental challenges to the traditional ways genomic information is communicated. These challenges will become increasingly complex and will affect a much larger population in the future if genomics is incorporated into standard newborn screening practice. Clinicians, public health officials, and other stakeholders will need to agree on the types of information that they should seek and communicate to parents.

Systematic review of the validity and reliability of consumer-wearable activity trackers.

Background: Consumer-wearable activity trackers are electronic devices used for monitoring fitness- and other health-related metrics. The purpose of this systematic review was to summarize the evidence for validity and reliability of popular consumer-wearable activity trackers (Fitbit and Jawbone) and their ability to estimate steps, distance, physical activity, energy expenditure, and sleep.

Methods: Searches included only full-length English language studies published in PubMed, Embase, SPORTDiscus, and Google Scholar through July 31, 2015.

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US.

Background: Preparing and submitting a voluntary adverse event (AE) report to the US Food and Drug Administration (FDA) for a medical device typically takes 40 min. User-friendly Web and mobile reporting apps may increase efficiency. Further, coupled with strategies for direct patient involvement, patient engagement in AE reporting may be improved.

Correlates of Adherence to Varenicline Among HIV+ Smokers.

Introduction: Low rates of adherence to smoking cessation pharmacotherapy may limit the effectiveness of treatment. However, few studies have examined adherence in smoking cessation trials thus, there is a limited understanding of factors that influence adherence behaviors. This brief report analyzes correlates of adherence to varenicline among people living with HIV/AIDS.

Formative Evaluation of a Text Messaging Intervention to Promote Varenicline Adherence Among Tobacco-Dependent Persons with HIV.

Few published studies describe processes in the development of mobile health interventions. This study reports data from a formative evaluation of a text messaging intervention being developed to increase adherence to smoking cessation medication (varenicline) among tobacco-dependent persons with HIV/AIDS. Four focus groups were conducted (N = 29) using a mixed-methods approach to assess: (a) beliefs and preferences regarding the use of varenicline, (b) preferences for receiving tobacco-related texts, and (c) the acceptability of draft text messages.

Underdeveloped or underreported? Coverage of pretesting practices and recommendations for design of text message-based health behavior change interventions.

Text messaging interventions for health are becoming increasingly popular, but it is unclear how rigorously such interventions are developed and pretested before being implemented. Pretesting is important to the development of successful health communication interventions. This study reviewed the literature published on text messaging health behavior change interventions and examined pretesting practices.