Advancing Wearable Biosensors for Congenital Heart Disease: Patient and Clinician Perspectives: A Science Advisory From the American Heart Association.

Wearable biosensors (wearables) enable continual, noninvasive physiologic and behavioral monitoring at home for those with pediatric or congenital heart disease. Wearables allow patients to access their personal data and monitor their health. Despite substantial technologic advances in recent years, issues with hardware design, data analysis, and integration into the clinical workflow prevent wearables from reaching their potential in high-risk congenital heart disease populations. This science advisory reviews the use of wearables in patients with congenital heart disease, how to improve these technologies for clinicians and patients, and ethical and regulatory considerations. Challenges related to the use of wearables are common to every clinical setting, but specific topics for consideration in congenital heart disease are highlighted.

Wearable Biosensors in Congenital Heart Disease: Needs to Advance the Field.

Traditional measures of clinical status and physiology have generally been based in health care settings, episodic, short in duration, and performed at rest. Wearable biosensors provide an opportunity to obtain continuous non-invasive physiologic data from patients with congenital heart disease (CHD) in the real-world setting, over longer durations, and across varying levels of activity. However, there are significant technical limitations to the use of wearable biosensors in CHD. Here, we review current applications of wearable biosensors in CHD; how clinical and research uses of wearable biosensors must consider various CHD physiologies; the technical challenges in developing wearable biosensors for CHD; and special considerations for digital biomarkers in CHD.

Co-curricular Immersion as a Public-Private Capacity Building Activity.

The COVID-19 pandemic exacerbated the already increasing challenge of establishing immersive, co-curricular activities for engineering students, particularly for biomedical-related activities. In the current work, we outline a strategy for co-curricular learning that leverages a private-public partnership in which methods for capacity-building have enabled mutually beneficial outcomes for both organizations. A contemporary issue for many non-profits is identifying effective ways to build capacity for consistent service delivery while at the same time embracing the volunteer activities of students; a challenge is that the lifecycle of a university student is often not aligned (much shorter) with the needs of the non-profit. The public-private partnership simultaneously meets the service motivation of students with the needs of the host. This paper includes two case studies that illustrate the implementation of the methods for capacity-building and related outcomes.

Needs assessment survey of healthcare providers' perceptions and practices regarding delirium prevention at a university medical center.

Background: Despite the high prevalence and serious implications of delirium, identification, tracking, and documentation of the condition remain a challenge for the health care team, impeding management of patients. This survey is the first phase of a qualitative study to build a conversational agent-based tool for screening and managing delirium-prone patients. Objectives: To assess healthcare providers' perceptions of delirium management, focusing on patient assessment, therapeutic interventions, and subsequent communication and documentation. Design: An electronic web-based survey was distributed to healthcare providers identified as caring for inpatient acutely ill older adults admitted for medical and orthopedic surgery needs. Respondent contact information was removed to preserve anonymity. Setting: A 1,000 bed university-affiliated teaching hospital in an urban setting. Participants: 23 residents in family practice, 36 residents in internal medicine, and a total of 492 advanced care nurses, nurses, and clinical staff. Approach: The analysis of survey responses provided insight into providers' current experiences with delirium assessment tools including computerized documentation, as well as their perceptions and attitudes toward delirium prevention. Key results: Most respondents (89%) thought delirium could be prevented, and 85% thought targeting delirium risk factors was helpful. Fifty one percent reported patients' loneliness and need for companionship, and 65% believed delirium was linked to higher mortality. Only 14% of respondents thought existing Electronic Health Record (EHR) alerts to identify high-risk delirium patients were useful, and 38% thought current delirium assessment protocols were helpful. In addition, 33% of nurses never received formal delirium prevention training, and 48% indicated that they needed improved systems to assess and manage patients at risk for delirium. Conclusion: A majority of providers affirmed that current delirium protocols are helpful; however, existing screening instruments and methods for documentation are cumbersome, resulting in incomplete or limited documentation of episodes. These barriers lead to an understatement of evidence available for continuous improvement of the patient management process.

Moot Court Cases: Bringing Standards to Life.

Biomedical engineering instructors teach the medical devices design theory and practice following the recommendations derived from the FDA regulations included in 21CFR820 and portraying it as less of a choice but the designer's obligation to uphold laws intended to reduce medical device design risk and protect the general public from defective goods. Although product liability cases are frequently adjudicated in a court of law, many students have only a vague notion of the link between design and product liability issues, and furthermore the important role that standards play in everyday design practice. To give real-life context for the connection between product liability and the benefits of using standards in design, we are aiming to develop moot court case studies that will offer engineering students the opportunity to investigate the viewpoint of various stakeholders and to bring arguments in support of their position. Our work-in-progress is part of a larger effort to reduce the barriers to standards adoption by engineering programs by creating a complete set of educational materials for educators based on specific case studies that foster consideration and use of standards in quality systems (ISO 13485:2016), and cyber-security in medical device design (ISO/IEEE 11073). Materials include lesson plans, content, and homework assignments that will be delivered as videos, tutorials, case study narratives, and Canvas modules. Our preliminary efforts have encouraged continuation of the development of content, though our efforts will benefit from other educator participation - this paper is a "Call to Action" for collaborators.

SETT: A Framework for Capacity Building Partnerships.

A contemporary issue for many non-profits is identifying effective ways to build capacity for service delivery. Interdisciplinary processes take time to carry out; herein lies a challenge when working with a university in which the lifecycle of student activity is not aligned (much shorter) that of the project for the alternative education program. In the current work, we describe the pathway of a partnership that improves the ability of nonprofit staff to achieve their mission while simultaneously meeting the service motivation in an academic setting. This paper describes the "pathway" for a mutually beneficial collaborative relationship between a higher education institution and a non-profit serving students with moderate to severe disabilities for the development of Assistive Technology using the SETT Framework as well as the Stanford BioDesign process.

Case Report: Return to Sport Following the COVID-19 Lockdown and Its Impact on Injury Rates in the German Soccer League.

The Bundesliga made headlines for becoming the first major sports league to return to sport worldwide following COVID-19 lockdown. To-date, there lacks retrospective studies on longitudinal injury rates to elucidate the effect isolation measures had on the health and safety of professional athletes. This study sought to compare injury rates experienced by Bundesliga athletes before and after the COVID-19 lockdown. Data was collected from public injury and player reports regarding the Bundesliga, with injury defined as trauma resulting in loss of game time. Descriptive statistics were used to present differences in injury incidence between all Bundesliga Match days pre- and post-lockdown. Between the league's resumption and completion on May 16 and June 27, 2020, injuries occurred in 21 forwards (FW), 11 central midfielders (CM), 12 wide midfielders (WM), 16 central defenders (CD), 6 fullbacks (FB), and 2 goalkeepers. Players had 1.13 (95% CI 0.78, 1.64) times the odds of being injured following the COVID-19 lockdown, with a 3.12 times higher rate of injury when controlling for games played compared to injury rates pre-lockdown (0.84 injuries per game vs. 0.27 injuries per game). The most frequent injury group was muscular injuries with 23 injuries total, with 17% of athletes experiencing injury during their first competitive match following lockdown. Injury rate increased over 3-fold following COVID-19 lockdown. Athletes did not experience an increased rate of injury with more cumulative competitive matches played. High injury incidence for players yet to complete their first competitive match may imply suboptimal sport readiness following home confinement.

Accuracy of the Apple Watch 4 to Measure Heart Rate in Patients With Atrial Fibrillation.

Background Wearable wrist-monitors offer an unobtrusive way to acquire heart rate data in an efficient manner. Previous work in this field has focused on studying healthy subjects during exercise but has yet to assess the efficacy of these devices in patients suffering from common cardiac arrhythmias such as atrial fibrillation. Objective The objective of this pilot study was to assess the accuracy of the Apple Watch heart rate monitor in fifty patients experiencing atrial fibrillation compared to telemetry. Results Results from this pilot clinical study demonstrated a correlation coefficient of 0.7 between all readings on the Apple Watch and telemetry. Furthermore, the Apple Watch assessed heart rate more accurately in patients who were in atrial fibrillation than in those that were not (rc = 0.86, patients in AF, vs. rc = 0.64, patients not in AF). Clinical Impact The presented data from this pilot study suggests that caution should be noted before using the Apple Watch 4 wearable wrist monitor to monitor heart rate in patients with cardiac arrhythmias such as atrial fibrillation.

Wearable Technology and Analytics as a Complementary Toolkit to Optimize Workload and to Reduce Injury Burden.

Wearable sensors enable the real-time and non-invasive monitoring of biomechanical, physiological, or biochemical parameters pertinent to the performance of athletes. Sports medicine researchers compile datasets involving a multitude of parameters that can often be time consuming to analyze in order to create value in an expeditious and accurate manner. Machine learning and artificial intelligence models may aid in the clinical decision-making process for sports scientists, team physicians, and athletic trainers in translating the data acquired from wearable sensors to accurately and efficiently make decisions regarding the health, safety, and performance of athletes. This narrative review discusses the application of commercial sensors utilized by sports teams today and the emergence of descriptive analytics to monitor the internal and external workload, hydration status, sleep, cardiovascular health, and return-to-sport status of athletes. This review is written for those who are interested in the application of wearable sensor data and data science to enhance performance and reduce injury burden in athletes of all ages.

Wearable Sensors for COVID-19: A Call to Action to Harness Our Digital Infrastructure for Remote Patient Monitoring and Virtual Assessments.

The COVID-19 pandemic has brought into sharp focus the need to harness and leverage our digital infrastructure for remote patient monitoring. As current viral tests and vaccines are slow to emerge, we see a need for more robust disease detection and monitoring of individual and population health, which could be aided by wearable sensors. While the utility of this technology has been used to correlate physiological metrics to daily living and human performance, the translation of such technology toward predicting the incidence of COVID-19 remains a necessity. When used in conjunction with predictive platforms, users of wearable devices could be alerted when changes in their metrics match those associated with COVID-19. Anonymous data localized to regions such as neighborhoods or zip codes could provide public health officials and researchers a valuable tool to track and mitigate the spread of the virus, particularly during a second wave. Identifiable data, for example remote monitoring of cohorts (family, businesses, and facilities) associated with individuals diagnosed with COVID-19, can provide valuable data such as acceleration of transmission and symptom onset. This manuscript describes clinically relevant physiological metrics which can be measured from commercial devices today and highlights their role in tracking the health, stability, and recovery of COVID-19+ individuals and front-line workers. Our goal disseminating from this paper is to initiate a call to action among front-line workers and engineers toward developing digital health platforms for monitoring and managing this pandemic.

Wearable sensors for monitoring the internal and external workload of the athlete.

The convergence of semiconductor technology, physiology, and predictive health analytics from wearable devices has advanced its clinical and translational utility for sports. The detection and subsequent application of metrics pertinent to and indicative of the physical performance, physiological status, biochemical composition, and mental alertness of the athlete has been shown to reduce the risk of injuries and improve performance and has enabled the development of athlete-centered protocols and treatment plans by team physicians and trainers. Our discussions in this review include commercially available devices, as well as those described in scientific literature to provide an understanding of wearable sensors for sports medicine. The primary objective of this paper is to provide a comprehensive review of the applications of wearable technology for assessing the biomechanical and physiological parameters of the athlete. A secondary objective of this paper is to identify collaborative research opportunities among academic research groups, sports medicine health clinics, and sports team performance programs to further the utility of this technology to assist in the return-to-play for athletes across various sporting domains. A companion paper discusses the use of wearables to monitor the biochemical profile and mental acuity of the athlete.

Wearable sensors for monitoring the physiological and biochemical profile of the athlete.

Athletes are continually seeking new technologies and therapies to gain a competitive edge to maximize their health and performance. Athletes have gravitated toward the use of wearable sensors to monitor their training and recovery. Wearable technologies currently utilized by sports teams monitor both the internal and external workload of athletes. However, there remains an unmet medical need by the sports community to gain further insight into the internal workload of the athlete to tailor recovery protocols to each athlete. The ability to monitor biomarkers from saliva or sweat in a noninvasive and continuous manner remain the next technological gap for sports medical personnel to tailor hydration and recovery protocols per the athlete. The emergence of flexible and stretchable electronics coupled with the ability to quantify biochemical analytes and physiological parameters have enabled the detection of key markers indicative of performance and stress, as reviewed in this paper.

Boundary spanning and health: invitation to a learning community.

Boundaries, which are essential for the healthy functioning of individuals and organisations, can become problematic when they limit creative thought and action. In this article, we present a framework for promoting health across boundaries and summarise preliminary insights from experience, conversations and reflection on how the process of boundary spanning may affect health. Boundary spanning requires specific individual qualities and skills. It can be facilitated or thwarted by organisational context. Boundary spanning often involves risk, but may reap abundant rewards. Boundary spanning is necessary to optimise health and health care. Exploring the process, the landscape and resources that enable boundary spanning may yield new opportunities for advancing health. We invite boundary spanners to join in a learning community to advance understanding and health.