Continuous Assessment of Active-Duty Army Special Operations and Reconnaissance Marines Using Digital Devices and Custom Software: The Digital Comprehensive Operator Readiness Assessment (DcORA) Study.

BACKGROUND: Continuous exposure to extreme and chronic stress from uncontrollable events has been linked to increased psychological and physiological reactivity. Prolonged, frequent deployments may test coping skills over time, ultimately rendering Servicemembers vulnerable to mental health problems and suicide. This study develops a methodology for accurately collecting holistic health measures from Servicemembers using digital tools, including custom-built phone software and body-worn sensors. METHODS: The secure research platform and mobile app continuously collect multiple health measures and, after data analysis, deliver continuously updated summary data back to the Servicemember. This system provides novel insights into the relationships between the measures while helping individuals track their progress toward self-established goals. Participants were given an iPhone (including the study app) and an Apple Watch. Participants tracked their data for more than 6 months and responded to baseline, daily, and weekly questions and assessments. Physiologic, psychologic, and cognitive assessment data across the Preservation of the Force and Family program (POTFF) domains were collected, displayed to the individual, and analyzed in aggregate. RESULTS: When coupled with custom-built software, this hardware can be elevated from a fitness tracker to a user-facing health monitoring, educational, and delivery system. CONCLUSION: This wearable system measured vital factors associated with the health and human performance of Servicemembers. In real-time, it engaged Servicemembers in health and human performance optimization practices to achieve a goal of prevention of physical or mental injury.

Force plate assessments in reconnaissance marine training company.

The ability to obtain dynamic movement assessments using force plate technology holds the promise of providing more detailed knowledge of the strength, balance and forces generated by active-duty military personnel. To date, there are not well-defined use cases for implementation of force plate assessments in military training environments. We sought to determine if force plate technology assessments could provide additional insights, related to the likelihood of graduation, beyond that provided by traditional physical fitness tests (PFT's), in an elite Marine training school. Serial force plate measures were also obtained on those Marines successfully completing training to determine if consistent measures reflecting the effects of training on muscle skeletal load-over-time could be accurately measured. A pre-training force plate assessment performed in 112 Marines did not predict graduation rates. For Marines who successfully completed the course, serial measures obtained throughout training were highly variable for each individual and no firm conclusions could be drawn related to load imposed or the fitness attained during training.

Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study.

BACKGROUND: The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown. METHODS: Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days. Participants within each cohort are randomized (3:1) to either a core digital engagement program (CDEP) via iPhone application (Heartline application) and an Apple Watch (Apple Watch Group) or CDEP alone (iPhone-only Group). The Apple Watch Group has the watch irregular rhythm notification (IRN) feature enabled and access to the ECG application on the Apple Watch. If an IRN notification is issued for suspected AF then the study application instructs participants in the Apple Watch Group to seek medical care. All participants were "watch-naïve" at time of enrollment and have an option to either buy or loan an Apple Watch as part of this study. The primary end point is time from randomization to clinical diagnosis of AF, with confirmation by health care claims. Key secondary endpoint are claims-based incidence of a 6-component composite cardiovascular/systemic embolism/mortality event, DOAC medication use and adherence, costs/health resource utilization, and frequency of hospitalizations for bleeding. All study assessments, including patient-reported outcomes, are conducted through the study application. The target study enrollment is approximately 28,000 participants in total; at time of manuscript submission, a total of 26,485 participants have been enrolled into the study. CONCLUSION: The Heartline Study will assess if an Apple Watch with the IRN and ECG application, along with application-facilitated digital health engagement modules, improves time to AF diagnosis and cardiovascular outcomes in a real-world environment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04276441.

A Novel Digital Research Methodology for Continuous Health Assessment of the Special Operations Warfighter: The Digital cORA Study.

The role of US Special Operations Forces (SOF) globally has expanded greatly in the past 20 years, leaving SOF serving multiple deployments with little time or ability to recover in between. Currently, assessments of the health and human performance capabilities of these individuals are episodic, precluding an accurate assessment of physical and mental load over time, and leading to high rates of acute and chronic injury to the mind and body. The collection of personal health-related continuous datasets has recently been made feasible with the advancement of digital technologies. These comprehensive data allow for improved assessment, and consequently better results, partly due to the warfighters' real-time access to their data. Such information allows Soldiers to engage in their own health optimization. This article describes a research platform that allows for collection of data via a custom-made secure mobile application that extends the type, scope, and frequency of data collection beyond what is feasible during an in-person encounter. By digitizing existing assessments and by incorporating additional physical, neurocognitive, psychological, and lifestyle assessments, the platform provides individuals with the ability to better understand their mental and physical load, as well as reserve. The results of this interactive exchange may help to preserve the health of users as well as the stability and readiness of units.

The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: an individual patient data meta-analysis of COMPANION and CARE-HF.

AIMS: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality for patients with heart failure, reduced left ventricular ejection fraction, QRS duration >130 ms and in sinus rhythm. The aim of this study was to identify patient characteristics that predict the effect, specifically, of CRT pacemakers (CRT-P) on all-cause mortality or the composite of hospitalization for heart failure or all-cause mortality. METHODS AND RESULTS: We conducted an individual patient data meta-analysis of the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) and Cardiac Resynchronization-Heart Failure (CARE-HF) trials. Only patients assigned to CRT-P or control (n = 1738) were included in order to avoid confounding from concomitant defibrillator therapy. The influence of baseline characteristics on treatment effects was investigated. Median age was 67 (59-73) years, most patients were men (70%), 68% had a QRS duration of 150-199 ms and 80% had left bundle branch block. Patients assigned to CRT-P had lower rates for all-cause mortality (hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.56-0.81; p < 0.0001) and the composite outcome (HR 0.67, 95% CI 0.58-0.78; p < 0.0001). No pre-specified characteristic, including sex, aetiology of ventricular dysfunction, QRS duration (within the studied range) or morphology or PR interval significantly influenced the effect of CRT-P on all-cause mortality or the composite outcome. However, CRT-P had a greater effect on the composite outcome for patients with lower body surface area and those prescribed beta-blockers. CONCLUSIONS: Cardiac resynchronization therapy-pacemaker reduces morbidity and mortality in appropriately selected patients with heart failure. Benefits may be greater in smaller patients and in those receiving beta-blockers. Neither QRS duration nor morphology independently predicted the benefit of CRT-P. CLINICAL TRIAL REGISTRATION: COMPANION, NCT00180258; CARE-HF, NCT00170300.

Diverse predictors of early attrition in an elite Marine training school.

Reconnaissance Marine training is deliberately difficult, to assure that graduates have the capabilities required to function successfully in the high-risk military occupational specialty. The majority of training attrition is due to voluntary withdrawal and previous research has identified certain predictive factors such as demographics, mental status, and physical performance. While some characteristics of training attrition have been identified, there is still a lack of understanding related to an individual's profile that is more apt to complete Recon training. Retrospective survey data was analyzed from 3,438 trainees within the Reconnaissance Training Company. Surveys were related to trainees' military recruitment history and other military experience, prior life experience, athletic experience, self-identified personality characteristics and motivations, and reasons for voluntary withdrawal if applicable, as well as physical performance metrics. Various demographic factors, self-reported hobbies, motivations, aquatic experience, and physical performance were associated with success in Recon Marine training courses. Subjects who voluntarily withdrew from training most commonly cited mental stress and aquatic rigor as the reason and less commonly cited reasons were physical and family reasons. These results could potentially increase training success, but more research is needed to understand the relationships between the observed trainee characteristics and success in elite warfighter training.

Player Tracking Technology and Data for Injury Prevention in the National Football League.

ABSTRACT: The recent partnership of NFL's Next Gen Stats with Amazon Web Services has created a buzz among media and fans, yet the full scope and utility of digital biosensors has yet to be determined. We review current uses of Global Positioning System technology and digital biosensors in the NFL and discuss the future role of this technology in injury prevention. A complete literature review was conducted, along with review of the NFL web site and news outlet articles, to obtain a comprehensive assessment of all prior and current uses of biosensor technology in the NFL. Limited data exist on successful injury prevention and return to play, and utilization of this emerging technology has mostly been for fan experience. While ethical and legal challenges exist, the integration of digital biosensor and GPS technology in the NFL has enormous potential and is an invaluable tool in the comprehensive assessment of player health.

Factors indicating intention to vaccinate with a COVID-19 vaccine among older U.S. adults.

BACKGROUND: The success of vaccination efforts to curb the COVID-19 pandemic will require broad public uptake of immunization and highlights the importance of understanding factors associated with willingness to receive a vaccine. METHODS: U.S. adults aged 65 and older enrolled in the HeartlineTM clinical study were invited to complete a COVID-19 vaccine assessment through the HeartlineTM mobile application between November 6-20, 2020. Factors associated with willingness to receive a COVID-19 vaccine were evaluated using an ordered logistic regression as well as a Random Forest classification algorithm. RESULTS: Among 9,106 study participants, 81.3% (n = 7402) responded and had available demographic data. The majority (91.3%) reported a willingness to be vaccinated. Factors most strongly associated with vaccine willingness were beliefs about the safety and efficacy of COVID-19 vaccines and vaccines in general. Women and Black or African American respondents reported lower willingness to vaccinate. Among those less willing to get vaccinated, 66.2% said that they would talk with their health provider before making a decision. During the study, positive results from the first COVID-19 vaccine outcome study were released; vaccine willingness increased after this report. CONCLUSIONS: Even among older adults at high-risk for COVID-19 complications who are participating in a longitudinal clinical study, 1 in 11 reported lack of willingness to receive COVID-19 vaccine in November 2020. Variability in vaccine willingness by gender, race, education, and income suggests the potential for uneven vaccine uptake. Education by health providers directed toward assuaging concerns about vaccine safety and efficacy can help improve vaccine acceptance among those less willing. TRIAL REGISTRATION: Clinicaltrials.gov NCT04276441.

The Addition of a Defibrillator to Resynchronization Therapy Decreases Mortality in Patients With Nonischemic Cardiomyopathy.

OBJECTIVES: The aim of this study was to determine whether patients with heart failure with reduced ejection fraction (HFrEF) due to nonischemic etiology eligible for cardiac resynchronization therapy (CRT) benefit from an implantable cardioverter-defibrillator (ICD). BACKGROUND: It is uncertain whether CRT with an ICD (CRT-D) compared to without an ICD (CRT-P) is associated with a survival benefit in patients with nonischemic etiologies of HFrEF. METHODS: Analyses of the COMPANION (Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure) trial were performed, using Cox proportional hazards modeling stratified by HFrEF etiology of nonischemic cardiomyopathy (NICM) or ischemic cardiomyopathy (ICM). The primary outcome was all-cause mortality (ACM), and secondary outcomes were the combination of cardiovascular mortality or heart failure hospitalization and sudden cardiac death. RESULTS: Among patients randomized to CRT (n = 1,212), 236 (19.5%) died, 131 and 105 in the CRT-P and CRT-D arms, respectively. The unadjusted and adjusted hazard ratios (HRs) for CRT-D versus CRT-P were both 0.84 (95% confidence interval [CI]: 0.65 to 1.09) for ACM, with a significant device-etiology interaction (pinteraction = 0.015 adjusted; pinteraction = 0.040 unadjusted). In patients with NICM (n = 555), CRT-D versus CRT-P was associated with reduced ACM (adjusted HR: 0.54; 95% CI: 0.34 to 0.86), while patients with ICM (n = 657) did not exhibit a between-device reduction in ACM (adjusted HR: 1.05; 95% CI: 0.77 to 1.44). The effects of CRT-D versus CRT-P on sudden cardiac death (advantage CRT-D) and cardiovascular mortality or heart failure hospitalization (no difference between CRT-P and CRT-D) were similar between the 2 HFrEF etiologies. CONCLUSIONS: COMPANION patients with NICM exhibited a decrease in ACM associated with CRT-D but not CRT-P treatment, whereas patients with ICM did not.

Home Monitoring of Cardiac Devices in the Era of COVID-19.

PURPOSE OF REVIEW: Despite the promise of remote patient monitoring (RPM), this technology remained underutilized secondary to a lack of data transparency and systems issues until the COVID-19 pandemic ushered in a new era of telehealth and virtual solutions out of necessity. This review will explore the data supporting the use of RPM via both implantable and wearable devices in the field of cardiology and the role of home monitoring using RPM in the era of COVID-19. RECENT FINDINGS: RPM using implantable cardiac devices is a safe alternative to in-person only visits which leads to enhanced patient satisfaction and improved clinical outcomes. Consumer-grade wearable sensors have drastically expanded RPM capabilities from just the sickest cardiac patients to the entire population aiding in early diagnosis and real-time disease management. Home monitoring enabled by automated alert systems tailored specifically to the needs of the patient by the provider will be the cornerstone of a more continuous, patent-centric healthcare model.

COVID-19 testing and infection surveillance: Is a combined digital contact-tracing and mass-testing solution feasible in the United States?

In December 2019, the novel COVID-19 virus spread from a cluster of pneumonia cases in Wuhan, China, to every corner of the globe, creating a worldwide pandemic pushing hospital systems past capacity and bringing economies worldwide to a halt. The COVID-19 pandemic is unique in comparison to prior coronavirus epidemics in its superior ability to be spread by asymptomatic and presymptomatic patients, allowing the virus to silently evade traditional symptoms-based screening approaches. Countries have implemented cutting-edge digital solutions to enhance traditional contact-tracing methodologies in combination with novel testing strategies to combat the virus, with variable levels of success. Despite having one of the most advanced and expensive health care systems in the world, the United States (U.S.) response is arguably one of the world's largest failures, as it leads the globe in case number as well as deaths. Until a successful vaccine can be broadly distributed, it is imperative that the U.S. curb the viral spread by rapidly developing a framework implementing both enhanced tracing and testing strategies balancing the needs of public health while respecting individual liberties. This review will explore the role of technology-augmented contact-based surveillance in tracking the outbreak in select countries in comparison to the current U.S. approach. It will evaluate barriers in the U.S. to implementing similar technologies, focusing on privacy concerns and a lack of unified testing and tracing strategy. Finally, it will explore strategies for rapidly scaling testing in a cost-effective manner.

Continuous Measurement of Reconnaissance Marines in Training With Custom Smartphone App and Watch: Observational Cohort Study.

BACKGROUND: Specialized training for elite US military units is associated with high attrition due to intense psychological and physical demands. The need to graduate more service members without degrading performance standards necessitates the identification of factors to predict success or failure in targeted training interventions. OBJECTIVE: The aim of this study was to continuously quantify the mental and physical status of trainees of an elite military unit to identify novel predictors of success in training. METHODS: A total of 3 consecutive classes of a specialized training course were provided with an Apple iPhone, Watch, and specially designed mobile app. Baseline personality assessments and continuous daily measures of mental status, physical pain, heart rate, activity, sleep, hydration, and nutrition were collected from the app and Watch data. RESULTS: A total of 115 trainees enrolled and completed the study (100% male; age: mean 22 years, SD 4 years) and 64 (55.7%) successfully graduated. Most training withdrawals (27/115, 23.5%) occurred by day 7 (mean 5.5 days, SD 3.4 days; range 1-22 days). Extraversion, positive affect personality traits, and daily psychological profiles were associated with course completion; key psychological factors could predict withdrawals 1-2 days in advance (P=.009). CONCLUSIONS: Gathering accurate and continuous mental and physical status data during elite military training is possible with early predictors of withdrawal providing an opportunity for intervention.

Impact of Degree of Left Ventricular Remodeling on Clinical Outcomes From Cardiac Resynchronization Therapy.

OBJECTIVES: This study tested the hypothesis that the extent of left ventricular (LV) eccentric structural remodeling in heart failure with reduced ejection fraction (HFrEF) is directly associated with clinical event responses to cardiac resynchronization therapy (CRT). BACKGROUND: Whether the severity of LV structural remodeling influences CRT treatment effects is unknown. METHODS: COMPANION (Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure) trial data were analyzed retrospectively. Left ventricular internal dimensions at end diastole indexed by body surface area (LVEDDI) were measured pre-randomization by 2-dimensional echocardiography. LVEDDI values were stratified around the median value of 35 mm/m2, and CRT (including CRT-P [CRT with only pacing capability] and/or CRT-D [CRT with an implantable defibrillator]) treatment effects were assessed and compared by LVEDDI group. Patients assigned to these treatments were compared to those undergoing optimal pharmacologic therapy (OPT) for the outcomes of all-cause mortality (ACM) or ACM and heart-failure hospitalization (ACM/HFH). RESULTS: In the LVEDDI ≥35 mm/m2 group (n = 614), CRT vs. OPT was associated with a lower ACM/HFH hazard ratio (HR) (HR: 0.53; 95% confidence interval [CI]: 0.40 to 0.70; p <0.001), whereas in the LVEDDI <35 mm/m2 group, the CRT vs. OPT ACM/HFH hazard ratio was not statistically significant (HR: 0.80; 95% CI: 0.59 to 1.08; p = 0.15). For ACM alone, in the LVEDDI ≥35 mm/m2 group, the hazard ratio for CRT-P was 0.59 (95% CI: 0.39 to 0.90; p = 0.012) and for CRT-D 0.50 (95% CI: 0.32 to 0.77; p = 0.002). Neither of the CRT groups showed a statistically significant reduction in ACM in the LVEDDI <35 mm/m2 group. CONCLUSIONS: Larger versus smaller LVEDDIs are associated with a reduction in ACM with CRT-P or CRT-D treatment, and with a more effective reduction in ACM/HFH for the combined CRT treatment groups.

Consumer-facing Diagnostic Sensors in a Patient with Implantable Cardioverter-Defibrillator.

Since its introduction in 2015, the Apple Watch (Apple Inc., Cupertino, CA, USA) has been purchased by an estimated 60 million consumers and boasts algorithms cleared by the United States Food and Drug Administration able to detect bradycardia, tachycardia, and atrial fibrillation, with the newest version of the device also allowing for real-time electrocardiogram acquisition. This case offers potentially the first demonstration of an Apple Watch correctly detecting atrial fibrillation with an implantable cardioverter-defibrillator confirming the accuracy of the detection from stored electrograms.

Competitive athletes with implantable cardioverter-defibrillators-How to program? Data from the Implantable Cardioverter-Defibrillator Sports Registry.

BACKGROUND: Athletes with an implantable cardioverter-defibrillator (ICD) may require unique optimal device-based tachycardia programming. OBJECTIVE: The purpose of this study was to assess the association of tachycardia programming characteristics of ICDs with occurrence of shocks, transient loss-of-consciousness, and death among athletes. METHODS: A subanalysis of a prospective, observational, international registry of 440 athletes with ICDs followed for a median of 44 months was performed. Programming characteristics were divided into groups for rate cutoff (very high, high, or low) and detection (long-detection interval [>nominal] or nominal). Endpoints included total, appropriate, and inappropriate shocks, transient loss-of-consciousness, and mortality. RESULTS: In this cohort, 62% were programmed with high-rate cutoff and 30% with long detection. No athlete died of an arrhythmia (related or unrelated) to ICD shocks. Three patients had sustained ventricular tachycardia below programmed detection rate, presenting as palpations and/or dizziness. ICD shocks were received by 98 athletes (64 appropriate, 32 inappropriate); 2 patients received both. Programming a high-rate cutoff was associated with decreased risk of total (P = .01) and inappropriate (P = .04) shocks overall and during competition or practice. Programming long-detection intervals was associated with fewer total shocks. Single- vs dual-chamber devices and the number of zones were unrelated to risk of shock. Transient loss-of-consciousness, associated with 27 appropriate shocks, was not related to programming characteristics. CONCLUSION: High-rate cutoff and long-detection duration programming of ICDs in athletes at risk for sudden death can reduce total and inappropriate ICD shocks without affecting survival or the incidence of transient loss-of-consciousness.

Haemodynamic Monitoring Devices in Heart Failure: Maximising Benefit with Digitally Enabled Patient Centric Care.

ICDs and resynchronisation devices are routinely implanted in patients with heart failure for primary prevention of sudden cardiac death or to treat the condition. The addition of device features and algorithms that directly or indirectly monitor cardiac haemodynamics to assess heart failure status can provide additional benefit by treating heart failure more continuously. Established and emerging devices and sensors aimed at treating or measuring cardiac haemodynamics represent the next era of heart failure disease management. Digitally enabled models of heart failure care, based on frequent haemodynamic measurements, will increasingly involve patients in their own disease management. Software tools and services tailored to provide patients with personalised information to guide diet, activity, medications and haemodynamic management offer an unprecedented opportunity to improve patient outcomes. This will enable physicians to care for larger populations because management will be exception based, automated and no longer depend on one-to-one patient and physician interactions.