Rigorous and rapid evidence assessment in digital health with the evidence DEFINED framework.

Dozens of frameworks have been proposed to assess evidence for digital health interventions (DHIs), but existing frameworks may not facilitate DHI evidence reviews that meet the needs of stakeholder organizations including payers, health systems, trade organizations, and others. These organizations may benefit from a DHI assessment framework that is both rigorous and rapid. Here we propose a framework to assess Evidence in Digital health for EFfectiveness of INterventions with Evaluative Depth (Evidence DEFINED). Designed for real-world use, the Evidence DEFINED Quick Start Guide may help streamline DHI assessment. A checklist is provided summarizing high-priority evidence considerations in digital health. Evidence-to-recommendation guidelines are proposed, specifying degrees of adoption that may be appropriate for a range of evidence quality levels. Evidence DEFINED differs from prior frameworks in its inclusion of unique elements designed for rigor and speed. Rigor is increased by addressing three gaps in prior frameworks. First, prior frameworks are not adapted adequately to address evidence considerations that are unique to digital health. Second, prior frameworks do not specify evidence quality criteria requiring increased vigilance for DHIs in the current regulatory context. Third, extant frameworks rarely leverage established, robust methodologies that were developed for non-digital interventions. Speed is achieved in the Evidence DEFINED Framework through screening optimization and deprioritization of steps that may have limited value. The primary goals of Evidence DEFINED are to a) facilitate standardized, rapid, rigorous DHI evidence assessment in organizations and b) guide digital health solutions providers who wish to generate evidence that drives DHI adoption.

A digital approach to asthma self-management in adults: Protocol for a pragmatic randomized controlled trial.

Asthma self-management can improve symptom control, but adherence to established self-management behaviors is often poor. With adult asthma uncontrolled in over 60% of U.S. cases, there is a need for scalable, cost-effective tools to improve asthma outcomes. Here we describe a protocol for the Asthma Digital Study, a 24-month, decentralized, pragmatic, open-label, randomized controlled trial investigating the impact of a digital asthma self-management (DASM) program on asthma outcomes in adults. The program leverages consumer-grade devices with a smartphone app to provide "smart nudges," symptom logging, trigger tracking, and other features. Participants are recruited (target N = 900) from throughout the U.S., and randomized to a DASM or control arm (1:1). Co-primary outcomes at one year are a) asthma-associated costs for acute care and b) change from baseline in Asthma Control Test™ scores. Findings may inform decisions around adoption of digital tools for asthma self-management. Trial registration:clinicaltrials.gov identifier: NCT04609644. Registered: Oct 30, 2020.

The Launch of the iCoDE Standard Project.

INTRODUCTION: The first meeting of the Integration of Continuous Glucose Monitor Data into the Electronic Health Record (iCoDE) project, organized by Diabetes Technology Society, took place virtually on January 27, 2022. METHODS: Clinicians, government officials, data aggregators, attorneys, and standards experts spoke in panels and breakout groups. Three themes were covered: 1) why digital health data integration into the electronic health record (EHR) is needed, 2) what integrated continuously monitored glucose data will look like, and 3) how this process can be achieved in a way that will satisfy clinicians, healthcare organizations, and regulatory experts. RESULTS: The meeting themes were addressed within eight sessions: 1) What Do Inpatient Clinicians Want to See With Integration of CGM Data into the EHR?, 2) What Do Outpatient Clinicians Want to See With Integration of CGM Data into the EHR?, 3) Why Are Data Standards and Guidances Useful?, 4) What Value Can Data Integration Services Add?, 5) What Are Examples of Successful Integration?, 6) Which Privacy, Security, and Regulatory Issues Must Be Addressed to Integrate CGM Data into the EHR?, 7) Breakout Group Discussions, and 8) Presentation of Breakout Group Ideas. CONCLUSIONS: Creation of data standards and workflow guidance are necessary components of the Integration of Continuous Glucose Monitor Data into the Electronic Health Record (iCoDE) standard project. This meeting, which launched iCoDE, will be followed by a set of working group meetings intended to create the needed standard.

Designing an Information and Communications Technology Tool With and for Victims of Violence and Their Case Managers in San Francisco: Human-Centered Design Study.

BACKGROUND: Violence is a public health problem. Hospital-based violence intervention programs such as the San Francisco Wraparound Project (WAP) have been shown to reduce future violent injury. The WAP model employs culturally competent case managers who recruit and enroll violently injured patients as clients. Client acceptance of the WAP intervention is variable, and program success depends on streamlined, timely communication and access to resources. High rates of smartphone usage in populations who are at risk for violent reinjury create an opportunity to design a tailored information and communications technology (ICT) tool to support hospital-based violence intervention programs. OBJECTIVE: Current evidence shows that ICT tools developed in the health care space may not be successful in engaging vulnerable populations. The goal of this study was to use human-centered design methodology to identify the unique communication needs of the clients and case managers at WAP to design a mobile ICT. METHODS: We conducted 15 semi-structured interviews with users: clients, their friends and families, case managers, and other stakeholders in violence intervention and prevention. We used a human-centered design and general inductive approach to thematic analysis to identify themes in the qualitative data, which were extrapolated to insight statements and then reframed into design opportunities. Wireframes of potential mobile ICT app screens were developed to depict these opportunities. RESULTS: Thematic analysis revealed four main insights that were characterized by the opposing needs of our users. (1) A successful relationship is both professional and personal. Clients need this around the clock, but case managers can only support this while on the clock. (2) Communications need to feel personal, but they do not always need to be personalized. (3) Healing is a journey of skill development and lifestyle changes that must be acknowledged, monitored, and rewarded. (4) Social networks need to provide peer support for healing rather than peer pressure to propagate violence. These insights resulted in the following associated design opportunities: (1) Maximize personal connection while controlling access, (2) allow case managers to personalize automated client interactions, (3) hold clients accountable to progress and reward achievements, and (4) build a connected, yet confidential community. CONCLUSIONS: Human-centered design enabled us to identify unique insights and design opportunities that may inform the design of a novel and tailored mobile ICT tool for the WAP community.

Operation CeaseFire-New Orleans: an infectious disease model for addressing community recidivism from penetrating trauma.

BACKGROUND: CeaseFire, using an infectious disease approach, addresses violence by partnering hospital resources with the community by providing violence interruption and community-based services for an area roughly composed of a single city zip code (70113). Community-based violence interrupters start in the trauma center from the moment penetrating trauma occurs, through hospital stay, and in the community after release. This study interprets statistics from this pilot program, begun May 2012. We hypothesize a decrease in penetrating trauma rates in the target area compared with others after program implementation. METHODS: This was a 3-year prospective data collection of trauma registry from May 2010 to May 2013. All intentional, target area, penetrating trauma treated at our Level I trauma center received immediate activation of CeaseFire personnel. Incidences of violent trauma and rates of change, by zip code, were compared with the same period for 2 years before implementation. RESULTS: During this period, the yearly incidence of penetrating trauma in Orleans Parish increased. Four of the highest rates were found in adjacent zip codes: 70112, 70113, 70119, and 70125. Average rates per 100,000 were 722.7, 523.6, 286.4, and 248, respectively. These areas represent four of the six zip codes citywide that saw year-to-year increases in violent trauma during this period. Zip 70113 saw a lower rate of rise in trauma compared with 70112 and a higher but comparable rise compared with that of 70119 and 70125. CONCLUSION: Hospital-based intervention programs that partner with culturally appropriate personnel and resources outside the institution walls have potential to have meaningful impact over the long term. While few conclusions of the effect of such a program can be drawn in a 12-month period, we anticipate long-term changes in the numbers of penetrating injuries in the target area and in the rest of the city as this program expands. LEVEL OF EVIDENCE: Therapeutic study, level IV.