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Background: The workload in health care is high; physicians and nurses report high stress levels due to a demanding environment where they often have to perform multiple tasks simultaneously. As a result, mental health issues among health care professionals (HCPs) are on the rise and the prevalence of errors in their daily tasks could increase. Processes of demographic change are partly responsible for even higher stress levels among HCPs. The digitization of patient care is intended to counteract these processes. However, it remains unclear whether these health information systems (HIS) and digital health technologies (DHT) support the HCPs and relieve stress, or if they represent a further burden. The mental construct that describes this burden of technologies is mental workload (MWL). Work in the clinic can be viewed as working in safety-critical environments. Particularly in this sensitive setting, the measurement methods of MWL are relevant, mainly due to their strongly differing levels of intrusiveness and sensitivity. The method of eye tracking could be a useful way to measure MWL directly in the field., Objective: The systematic review aims to address the following questions: (1) In which manner do DHT contribute to the overall MWL of HCPs? (2) Can we observe a direct or indirect effect of DHT on MWL? (3) Which aspects or factors of DHT contribute to an increase in MWL? (4) Which methods/assessments are applied to measure MWL related to HIS/DHT? (5) What role does eye tracking/pupillometry play in the context of measuring MWL? (6) Which outcomes are being assessed via eye tracking?, Methods: Following the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) statement, we will conduct a systematic review. Based on the research questions, we define keywords that we then combine in search terms. The review follows the following steps: literature search, article selection, data extraction, risk of bias assessment, data analysis, and data synthesis., Results: We expect results as well as a finalization of the review in the summer of 2021., Conclusions: This review will evaluate the impact of DHT on the MWL of HCPs. In addition, assessment methods of MWL in the context of digital technologies will be systematically analyzed., Trial Registration: PROSPERO (International Prospective Register of Systematic Reviews) CRD42021233271; https://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42021233271., International Registered Report Identifier (irrid): DERR1-10.2196/29126., (©Lisanne Kremer, Myriam Lipprandt, Rainer Röhrig, Bernhard Breil. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.08.2021.)

Historically healthcare has been delivered offline (e.g., physician consultations, mental health counseling services). It is widely understood that healthcare lags behind other industries (e.g., financial, transportation) whom have already incorporated digital technologies in their workflow. However, this is changing with the recent emergence of digital therapeutics (DTx) helping to bring healthcare services online. To promote adoption, healthcare providers need to be educated regarding the digital therapy to allow for proper prescribing. But of equal importance is affordability and many countries rely on reimbursement support from the government and insurance agencies. Here we briefly explore how national reimbursement agencies or non-profits across six countries (Canada, United States of America, United Kingdom, Germany, France, Australia) handle DTx submissions and describe the potential impact of digital therapeutics on current health technology assessment (HTA) frameworks. A targeted review to identify HTA submissions and guidelines from national reimbursement agencies or non-profits was conducted. We reviewed guidelines from the Institute for Clinical and Economic Review (ICER) in the USA, the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada, the National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK), the Institute for Quality and Efficiency in Health Care (IQWIG) in Germany, Haute Autorité de Santé (HAS) in France, and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia. Our review identified one set of guidelines developed by NICE in the UK. The guidelines by NICE outlined an evidence standards framework for digital health technologies (DHT). Depending on the organizational impact, financial commitment, and economic risk for the payer, different economic analyses are required. Economic analyses levels are separated into 3 categories, basic, low financial commitment, and high financial commitment. All economic analyses levels require a budget impact analysis. A cost-utility analysis is recommended for DHTs categorized in the high financial commitment category. Whereas, for DHTs that are in the low financial commitment category, a cost-consequence analysis is typically recommended. No HTA guidelines for DTx submissions were identified for the remaining countries (Canada, USA, Germany, France, and Australia)., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Yan, Balijepalli and Druyts.)

Background: Strengthening health systems to improve access to maternity services remains challenging for Nigeria due partly to weak and irregular in-service training and deficient data management. This paper reports the implementation of digital health tools for video training (VTR) of health workers and digitization of health data at scale, supported by satellite communications (SatCom) technology and existing 3G mobile networks. Objective: To understand whether, and under what circumstances using digital interventions to extend maternal, newborn and child health (MNCH) services to remote areas of Nigeria improved standards of healthcare delivery. Methods: From March 2017 to March 2019, VTR and data digitization interventions were delivered in 126 facilities across three states of Nigeria. Data collection combined documents review with 294 semi-structured interviews of stakeholders across four phases (baseline, midline, endline, and 12-months post-project closedown) to assess acceptability and impacts of digital interventions. Data was analyzed using a framework approach, drawing on a modified Technology Acceptance Model to identify factors that shaped technology adoption and use. Results: Analysis of documents and interview transcripts revealed that a supportive policy environment, and track record of private-public partnerships facilitated adoption of technology. The determinants of technology acceptance among health workers included ease of use, perceived usefulness, and prior familiarity with technology. Perceptions of impact suggested that at the micro (individual) level, repeated engagement with clinical videos increased staff knowledge, motivation and confidence to perform healthcare roles. At meso (organizational) level, better-trained staff felt supported and empowered to provide respectful healthcare and improved management of obstetric complications, triggering increased use of MNCH services. The macro level saw greater use of reliable and accurate data for policymaking. Conclusions: Simultaneous and sustained implementation of VTR and data digitization at scale enabled through SatCom and 3G mobile networks are feasible approaches for supporting improvements in staff confidence and motivation and reported MNCH practices. By identifying mechanisms of impact of digital interventions on micro, meso, and macro levels of the health system, the study extends the evidence base for effectiveness of digital health and theoretical underpinnings to guide further technology use for improving MNCH services in low resource settings. Trial Registration: ISRCTN32105372., Competing Interests: OO is Co-Founder and CEO of InStrat Global Health Solutions, the company that implemented the digital technologies used in the outlined study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Ebenso, Okusanya, Okunade, Akeju, Ajepe, Akaba, Yalma, Dirisu, Tukur, Abdullahi, Okuzu and Allsop.)

Background: The successful adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders, including clinical investigators; however, little information is known about the perspectives of investigators using mobile technologies in clinical trials., Objective: The aim of this study was to seek investigators' insights on the advantages and challenges of mobile clinical trials (MCTs); site-level budgetary, training, and other support needs necessary to adequately prepare for and implement MCTs; and the advantages and disadvantages for trial participants using mobile technologies in clinical trials., Methods: Using a qualitative descriptive study design, we conducted in-depth interviews with investigators involved in the conduct of MCTs. Data were analyzed using applied thematic analysis., Results: We interviewed 12 investigators who represented a wide variety of clinical specialties and reported using a wide range of mobile technologies. Investigators most commonly cited 3 advantages of MCTs over traditional clinical trials: more streamlined study operations, remote data capture, and improvement in the quality of studies and data collected. Investigators also reported that MCTs can be designed around the convenience of trial participants, and individuals may be more willing to participate in MCTs because they can take part from their homes. In addition, investigators recognized that MCTs can also involve additional burden for participants and described that operational challenges, technology adoption barriers, uncertainties about data quality, and time burden made MCTs more challenging than traditional clinical trials. Investigators stressed that additional training and dedicated staff effort may be needed to select a particular technology for use in a trial, helping trial participants learn and use the technology, and for staff troubleshooting the technology. Investigators also expressed that sharing data collected in real time with investigators and trial participants is an important aspect of MCTs that warrants consideration and potentially additional training and education., Conclusions: Investigator perspectives can inform the use of mobile technologies in future clinical trials by proactively identifying and addressing potential challenges., (©Kevin Christopher McKenna, Cindy Geoghegan, Teresa Swezey, Brian Perry, William A Wood, Virginia Nido, Steve L Morin, Brigid K Grabert, Zachary P Hallinan, Amy L Corneli. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 12.02.2021.)

Digital health technology (DHT) has the potential to revolutionize healthcare delivery but its uptake has been low in clinical and research settings. The factors that contribute to the limited adoption of DHT, particularly in cardiovascular settings, are unclear. The objective of this review was to determine the barriers and facilitators of DHT uptake from the perspective of patients, clinicians, and researchers. We searched MEDLINE, EMBASE, and CINAHL databases for studies published from inception to May 2020 that reported barriers and/or facilitators of DHT adoption in cardiovascular care. We extracted data on study design, setting, cardiovascular condition, and type of DHT. We conducted a thematic analysis to identify barriers and facilitators of DHT uptake. The search identified 3075 unique studies, of which 29 studies met eligibility criteria. Studies employed: qualitative methods ( n = 13), which included interviews and focus groups; quantitative methods ( n = 5), which included surveys; or a combination of qualitative and quantitative methods ( n = 11). Twenty-five studies reported patient-level barriers, most common of which were difficult-to-use technology ( n =7) and a poor internet connection ( n =7). Six studies reported clinician-level barriers, which included increased workload ( n =4) and a lack of integration with electronic medical records ( n =3).Twenty-four studies reported patient-level facilitators, which included improved communication with clinicians ( n =10) and personalized technology ( n =6). Four studies reported clinician-level facilitators, which included approval and organizational support from cardiology departments and/or hospitals ( n =3) and technologies that improved efficiency ( n =3). No studies reported researcher-level barriers or facilitators. In summary, internet access, user-friendliness, organizational support, workflow efficiency, and data integration were reported as important factors in the uptake of DHT by patients and clinicians. These factors can be considered when selecting and implementing DHTs in cardiovascular clinical settings., (The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Older adults with multimorbidity and complex care needs (CCN) are among those most likely to experience frequent care transitions between settings, particularly from hospital to home. Transition periods mark vulnerable moments in care for individuals with CCN. Poor communication and incomplete information transfer between clinicians and organizations involved in the transition from hospital to home can impede access to needed support and resources. Establishing digitally supported communication that enables person-centered care and supported self-management may offer significant advantages as we support older adults with CCN transitioning from hospital to home., Objective: This protocol outlines the plan for the development, implementation, and evaluation of a Digital Bridge co-designed to support person-centered health care transitions for older adults with CCN. The Digital Bridge builds on the foundation of two validated technologies: Care Connector, designed to improve interprofessional communication in hospital, and the electronic Patient-Reported Outcomes (ePRO) tool, designed to support goal-oriented care planning and self-management in primary care settings. This project poses three overarching research questions that focus on adapting the technology to local contexts, evaluating the impact of the Digital Bridge in relation to the quadruple aim, and exploring the potential to scale and spread the technology., Methods: The study includes two phases: workflow co-design (phase 1), followed by implementation and evaluation (phase 2). Phase 1 will include iterative co-design working groups with patients, caregivers, hospital providers, and primary care providers to develop a transition workflow that will leverage the use of Care Connector and ePRO to support communication through the transition process. Phase 2 will include implementation and evaluation of the Digital Bridge within two hospital systems in Ontario in acute and rehab settings (600 patients: 300 baseline and 300 implementation). The primary outcome measure for this study is the Care Transitions Measure-3 to assess transition quality. An embedded ethnography will be included to capture context and process data to inform the implementation assessment and development of a scale and spread strategy. An Integrated Knowledge Translation approach is taken to inform the study. An advisory group will be established to provide insight and feedback regarding the project design and implementation, leading the development of the project knowledge translation strategy and associated outputs., Results: This project is underway and expected to be complete by Spring 2024., Conclusions: Given the real-world implementation of Digital Bridge, practice changes in the research sites and variable adherence to the implementation protocols are likely. Capturing and understanding these considerations through a mixed-methods approach will help identify the range of factors that may influence study results. Should a favorable evaluation suggest wide adoption of the proposed intervention, this project could lead to positive impact at patient, clinician, organizational, and health system levels., Trial Registration: ClinicalTrials.gov NCT04287192; https://clinicaltrials.gov/ct2/show/NCT04287192., International Registered Report Identifier (irrid): PRR1-10.2196/20220., (©Carolyn Steele Gray, Terence Tang, Alana Armas, Mira Backo-Shannon, Sarah Harvey, Kerry Kuluski, Mayura Loganathan, Jason X Nie, John Petrie, Tim Ramsay, Robert Reid, Kednapa Thavorn, Ross Upshur, Walter P Wodchis, Michelle Nelson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.11.2020.)

Background: Hand hygiene is one of the most effective ways to remove germs, prevent the spread of infectious pathogens, and avoid getting sick. Since the COVID-19 pandemic began, health authorities have been advocating good hand hygiene practices., Objective: The primary aim of this study is to field test a prototype smart handwashing station deployed in a school setting during the COVID-19 pandemic., Methods: We deployed a smart handwashing station and examined key technological considerations including connectivity, security, and data management systems, as well as the health and safety of users., Results: The smart handwashing station was deployed for 10 days in a school setting in Australia during the COVID-19 pandemic. The smart handwashing station's electrical components remained operational during field testing and underwent robust cleaning protocols each day. The handwashing station was used 1138 times during the field test and there was no COVID-19 transmission at the school during the testing., Conclusions: This study demonstrates that a personalized feedback approach using technology can successfully be implemented at a school and can provide a platform to improve hand hygiene among school-aged children., (©Jeremy Herbert, Caitlin Horsham, Helen Ford, Alexander Wall, Elke Hacker. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 19.10.2020.)

In order to harness the potential of digital health technologies to enhance the quality of clinical research, it is critical to first understand how to engage patients and research sites when planning and conducting digital health trials. To pave the way for the more effective use of digital health technologies in trials, the Clinical Trials Transformation Initiative has developed the first comprehensive, evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials. While directed primarily at sponsors, these recommendations are expected to be valuable for all stakeholders including investigators., Competing Interests: The authors have no conflicting interests to disclose., (© 2020 Published by Elsevier Inc.)

At the 56th Global Annual Meeting of the Drug Information Association (DIA), attendees met virtually during the height of the global COVID-19 pandemic for "rapid cross-stakeholder, cross-border collaboration" to support health worldwide. Sessions included presenters and speakers from regulatory, patient advocacy and academia sectors, with patients at the forefront of those discussions. This report covers various presentations and panel discussions from the 4-day meeting that focus on COVID-19, innovative trial designs spurred by a need to adapt amid a pandemic, digital health, novel products inspiring new regulatory standards, clinical trials, data collection and management, the need for more and better data and the ever-increasing importance of the patient perspective., (Copyright 2020 Clarivate Analytics.)

Technology has redefined the way patients and providers communicate and obtain health information. The realm of digital health encompasses a diverse set of technologies, including mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. These technologies have begun to improve care delivery without the traditional constraints of distance, location, and time. A growing body of evidence supports the use of digital health technology for improving patient education and implementation of skills and behaviors integral to lifestyle medicine. Patient education can now be delivered in standard formats (eg, articles, written messages) as well a wide array of multimedia (video, audio, interactive games, etc), which may be more appropriate for certain topics and learning styles. In addition, patient engagement in their care plays an important role in improving health outcomes. Despite digital health technology development often outpacing its research, there is sufficient evidence to support the use of many current technologies in clinical practice. Digital health tools will continue to grow in their ability to cost-effectively monitor and encourage healthy behaviors at scale, and better methods of evaluation will likely increase clinician confidence in their use., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2019 The Author(s).)

Digital health technologies (smartphones, smartwatches, and other body-worn sensors) can act as novel tools to aid in the diagnosis and remote objective monitoring of an individual's disease symptoms, both in clinical care and in research. Nonetheless, such digital health technologies have yet to widely demonstrate value in clinical research due to insufficient data interpretability and lack of regulatory acceptance. Metadata, i.e., data that accompany and describe the primary data, can be utilized to better understand the context of the sensor data and can assist in data management, data sharing, and subsequent data analysis. The need for data and metadata standards for digital health technologies has been raised in academic and industry research communities and has also been noted by regulatory authorities. Therefore, to address this unmet need, we here propose a metadata set that reflects regulatory guidelines and that can serve as a conceptual map to (1) inform researchers on the metadata they should collect in digital health studies, aiming to increase the interpretability and exchangeability of their data, and (2) direct standard development organizations on how to extend their existing standards to incorporate digital health technologies. The proposed metadata set is informed by existing standards pertaining to clinical trials and medical devices, in addition to existing schemas that have supported digital health technology studies. We illustrate this specifically in the context of Parkinson's disease, as a model for a wide range of other chronic conditions for which remote monitoring would be useful in both care and science. We invite the scientific and clinical research communities to apply the proposed metadata set to ongoing and planned research. Where the proposed metadata fall short, we ask users to contribute to its ongoing revision so that an adequate degree of consensus can be maintained in a rapidly evolving technology landscape., Competing Interests: J.M. Cedarbaum is an employee of and shareholder in Biogen, Inc. W. Maetzler and A.J. Espay are co-chairs of the International Parkinson's and Movement Disorders Society Task Force on Technology. The remaining authors have no conflicts of interest to declare., (Copyright © 2019 by S. Karger AG, Basel.)

As we enter the information age of health care, digital health technologies offer significant opportunities to optimize both clinical care delivery and clinical research. Despite their potential, the use of such information technologies in clinical care and research faces major data quality, privacy, and regulatory concerns. In hopes of addressing both the promise and challenges facing digital health technologies in the transformation of health care, we convened a think tank meeting with academic, industry, and regulatory representatives in December 2016 in Washington, DC. In this paper, we summarize the proceedings of the think tank meeting and aim to delineate a framework for appropriately using digital health technologies in healthcare delivery and research., (Copyright © 2018 American College of Cardiology Foundation. All rights reserved.)