HCI-modelling for improving the clinical usability of digital health technologies.

INTRODUCTION: Digital Health Technologies (DHTs) have been shown to have variable usability as measured by efficiency, effectiveness and user satisfaction despite large-scale government projects to regulate and standardise user interface (UI) design. We hypothesised that Human-Computer Interaction (HCI) modelling could improve the methodology for DHT design and regulation, and support the creation of future evidence-based UI standards and guidelines for DHTs. METHODOLOGY: Using a Design Science Research (DSR) framework, we developed novel UI components that adhered to existing standards and guidelines (combining the NHS Common User Interface (CUI) standard and the NHS Design System). We firstly evaluated the Patient Banner UI component for compliance with the two guidelines and then used HCI-modelling to evaluate the "Add New Patient" workflow to measure time to task completion and cognitive load. RESULTS: Combining the two guidelines to produce new UI elements is technically feasible for the Patient Banner and the Patient Name Input components. There are some inconsistencies between the NHS Design System and the NHS CUI when implementing the Patient Banner. HCI-modelling successfully quantified challenges adhering to the NHS CUI and the NHS Design system for the "Add New Patient" workflow. DISCUSSION: We successfully developed new design artefacts combing two major design guidelines for DHTs. By quantifying usability issues using HCI-modelling, we have demonstrated the feasibility of a methodology that combines HCI-modelling into a human-centred design (HCD) process could enable the development of standardised UI elements for DHTs that is more scientifically robust than HCD alone. CONCLUSION: Combining HCI-modelling and Human-Centred Design could improve scientific progress towards developing safer and more user-friendly DHTs.

Barriers and facilitators to the implementation of digital technologies in mental health systems: a qualitative systematic review to inform a policy framework.

BACKGROUND: Despite the potential for improved population mental health and wellbeing, the integration of mental health digital interventions has been difficult to achieve. In this qualitative systematic review, we aimed to identify barriers and facilitators to the implementation of digital technologies in mental healthcare systems, and map these to an implementation framework to inform policy development. METHODS: We searched Medline, Embase, Scopus, PsycInfo, Web of Science, and Google Scholar for primary research articles published between January 2010 and 2022. Studies were considered eligible if they reported barriers and/or facilitators to the integration of any digital mental healthcare technologies. Data were extracted using EPPI-Reviewer Web and analysed thematically via inductive and deductive cycles. RESULTS: Of 12,525 references identified initially, 81 studies were included in the final analysis. Barriers and facilitators were grouped within an implementation (evidence-practice gap) framework across six domains, organised by four levels of mental healthcare systems. Broadly, implementation was hindered by the perception of digital technologies as impersonal tools that add additional burden of care onto both providers and patients, and change relational power asymmetries; an absence of resources; and regulatory complexities that impede access to universal coverage. Facilitators included person-cantered approaches that consider patients' intersectional features e.g., gender, class, disability, illness severity; evidence-based training for providers; collaboration among colleagues; appropriate investment in human and financial resources; and policy reforms that tackle universal access to digital health. CONCLUSION: It is important to consider the complex and interrelated nature of barriers across different domains and levels of the mental health system. To facilitate the equitable, sustainable, and long-term digital transition of mental health systems, policymakers should consider a systemic approach to collaboration between public and private sectors to inform evidence-based planning and strengthen mental health systems. PROTOCOL REGISTRATION: The protocol is registered on PROSPERO, CRD42021276838.

Stepping Forward: A Scoping Systematic Literature Review on the Health Outcomes of Smart Sensor Technologies for Diabetic Foot Ulcers.

Diabetic foot ulcers (DFUs) pose a significant challenge in diabetes care, demanding advanced approaches for effective prevention and management. Smart insoles using sensor technology have emerged as promising tools to address the challenges associated with DFU and neuropathy. By recognizing the pivotal role of smart insoles in successful prevention and healthcare management, this scoping review aims to present a comprehensive overview of the existing evidence regarding DFU studies related to smart insoles, offloading sensors, and actuator technologies. This systematic review identified and critically evaluated 11 key studies exploring both sensor technologies and offloading devices in the context of DFU care through searches in CINAHL, MEDLINE, and ScienceDirect databases. Predominantly, smart insoles, mobile applications, and wearable technologies were frequently utilized for interventions and patient monitoring in diabetic foot care. Patients emphasized the importance of these technologies in facilitating care management. The pivotal role of offloading devices is underscored by the majority of the studies exhibiting increased efficient monitoring, prevention, prognosis, healing rate, and patient adherence. The findings indicate that, overall, smart insoles and digital technologies are perceived as acceptable, feasible, and beneficial in meeting the specific needs of DFU patients. By acknowledging the promising outcomes, the present scoping review suggests smart technologies can potentially redefine DFU management by emphasizing accessibility, efficacy, and patient centricity.

Lessons for Vietnam on the Use of Digital Technologies to Support Patient-Centered Care in Low- and Middle-Income Countries in the Asia-Pacific Region: Scoping Review.

BACKGROUND: A rapidly aging population, a shifting disease burden and the ongoing threat of infectious disease outbreaks pose major concerns for Vietnam's health care system. Health disparities are evident in many parts of the country, especially in rural areas, and the population faces inequitable access to patient-centered health care. Vietnam must therefore explore and implement advanced solutions to the provision of patient-centered care, with a view to reducing pressures on the health care system simultaneously. The use of digital health technologies (DHTs) may be one of these solutions. OBJECTIVE: This study aimed to identify the application of DHTs to support the provision of patient-centered care in low- and middle-income countries in the Asia-Pacific region (APR) and to draw lessons for Vietnam. METHODS: A scoping review was undertaken. Systematic searches of 7 databases were conducted in January 2022 to identify publications on DHTs and patient-centered care in the APR. Thematic analysis was conducted, and DHTs were classified using the National Institute for Health and Care Excellence evidence standards framework for DHTs (tiers A, B, and C). Reporting was in line with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. RESULTS: Of the 264 publications identified, 45 (17%) met the inclusion criteria. The majority of the DHTs were classified as tier C (15/33, 45%), followed by tier B (14/33, 42%) and tier A (4/33, 12%). At an individual level, DHTs increased accessibility of health care and health-related information, supported individuals in self-management, and led to improvements in clinical and quality-of-life outcomes. At a systems level, DHTs supported patient-centered outcomes by increasing efficiency, reducing strain on health care resources, and supporting patient-centered clinical practice. The most frequently reported enablers for the use of DHTs for patient-centered care included alignment of DHTs with users' individual needs, ease of use, availability of direct support from health care professionals, provision of technical support as well as user education and training, appropriate governance of privacy and security, and cross-sectorial collaboration. Common barriers included low user literacy and digital literacy, limited user access to DHT infrastructure, and a lack of policies and protocols to guide the implementation and use of DHTs. CONCLUSIONS: The use of DHTs is a viable option to increase equitable access to quality, patient-centered care across Vietnam and simultaneously reduce pressures on the health care system. Vietnam can take advantage of the lessons learned by other low- and middle-income countries in the APR when developing a national road map to digital health transformation. Recommendations that Vietnamese policy makers may consider include emphasizing stakeholder engagement, strengthening digital literacy, supporting the improvement of DHT infrastructure, increasing cross-sectorial collaboration, strengthening governance of cybersecurity, and leading the way in DHT uptake.

Wearable Sensor Technologies to Assess Motor Functions in People With Multiple Sclerosis: Systematic Scoping Review and Perspective.

BACKGROUND: Wearable sensor technologies have the potential to improve monitoring in people with multiple sclerosis (MS) and inform timely disease management decisions. Evidence of the utility of wearable sensor technologies in people with MS is accumulating but is generally limited to specific subgroups of patients, clinical or laboratory settings, and functional domains. OBJECTIVE: This review aims to provide a comprehensive overview of all studies that have used wearable sensors to assess, monitor, and quantify motor function in people with MS during daily activities or in a controlled laboratory setting and to shed light on the technological advances over the past decades. METHODS: We systematically reviewed studies on wearable sensors to assess the motor performance of people with MS. We scanned PubMed, Scopus, Embase, and Web of Science databases until December 31, 2022, considering search terms "multiple sclerosis" and those associated with wearable technologies and included all studies assessing motor functions. The types of results from relevant studies were systematically mapped into 9 predefined categories (association with clinical scores or other measures; test-retest reliability; group differences, 3 types; responsiveness to change or intervention; and acceptability to study participants), and the reporting quality was determined through 9 questions. We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guidelines. RESULTS: Of the 1251 identified publications, 308 were included: 176 (57.1%) in a real-world context, 107 (34.7%) in a laboratory context, and 25 (8.1%) in a mixed context. Most publications studied physical activity (196/308, 63.6%), followed by gait (81/308, 26.3%), dexterity or tremor (38/308, 12.3%), and balance (34/308, 11%). In the laboratory setting, outcome measures included (in addition to clinical severity scores) 2- and 6-minute walking tests, timed 25-foot walking test, timed up and go, stair climbing, balance tests, and finger-to-nose test, among others. The most popular anatomical landmarks for wearable placement were the waist, wrist, and lower back. Triaxial accelerometers were most commonly used (229/308, 74.4%). A surge in the number of sensors embedded in smartphones and smartwatches has been observed. Overall, the reporting quality was good. CONCLUSIONS: Continuous monitoring with wearable sensors could optimize the management of people with MS, but some hurdles still exist to full clinical adoption of digital monitoring. Despite a possible publication bias and vast heterogeneity in the outcomes reported, our review provides an overview of the current literature on wearable sensor technologies used for people with MS and highlights shortcomings, such as the lack of harmonization, transparency in reporting methods and results, and limited data availability for the research community. These limitations need to be addressed for the growing implementation of wearable sensor technologies in clinical routine and clinical trials, which is of utmost importance for further progress in clinical research and daily management of people with MS. TRIAL REGISTRATION: PROSPERO CRD42021243249; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=243249.

Empowerment through health self-testing apps? Revisiting empowerment as a process.

Empowerment, an already central concept in public health, has gained additional relevance through the expansion of mobile health (mHealth). Especially direct-to-consumer self-testing app companies mobilise the term to advertise their products, which allow users to self-test for various medical conditions independent of healthcare professionals. This article first demonstrates the absence of empowerment conceptualisations in the context of self-testing apps by engaging with empowerment literature. It then contrasts the service these apps provide with two widely cited empowerment definitions by the WHO, which describe the term as a process that, broadly, leads to knowledge and control of health decisions. We conclude that self-testing apps can only partly empower their users, as they, we argue, do not provide the type of knowledge and control the WHO definitions describe. More importantly, we observe that this shortcoming stems from the fact that in the literature on mHealth and in self-testing marketing, empowerment is understood as a goal rather than a process. This characterises a shift in the meaning of empowerment in the context of self-testing and mHealth, one that reveals a lack of awareness for relational and contextual factors that contribute to empowerment. We argue that returning to a process-understanding of empowerment helps to identify these apps' deficits, and we conclude the article by briefly suggesting several strategies to increase self-testing apps' empowerment function.

Promoting Self-Management and Independent Living of Older Individuals with Chronic Diseases through Technology: A Study of Self-Reported Needs, Priorities, and Preferences.

Background and Objectives: Older patients' needs are rarely examined beforehand, and thus, although technology-based tools can enhance self-management, acceptability rates are still low. This study aimed to examine and compare self-reported needs, priorities, and preferences of older patients with heart failure (HF), diabetes mellitus type II (DM2), and chronic obstructive pulmonary disease (COPD) toward technology use to enhance self-management. Materials and Methods: A convenience sample of 473 participants over 60 s (60.5% females), diagnosed with HF (n= 156), DM2 (n = 164), or COPD (n = 153) was recruited. They were administered a questionnaire about the usefulness of technology in general and in specific areas of disease management. Results: Most participants (84.7%) admitted that technology is needed for better disease management. This was equally recognized across the three groups both for the overall and specific areas of disease management (in order of priority: "Information", "Communication with Physicians and Caregivers", and "Quality of Life and Wellbeing"). Sociodemographic differences were found. Cell phones and PCs were the devices of preference. The four common features prioritized by all three groups were related to 'information about disease management' (i.e., monitoring symptoms, reminders for medication intake, management and prevention of complications), whereas the fifth one was related to 'communication with physicians and caregivers (i.e., in case of abnormal or critical signs). The top disease-specific feature was also monitoring systems (of respiratory rate or blood sugar or blood pressure, and oxygen), whereas other disease-specific features followed (i.e., maintaining normal weight for HF patients, adjusting insulin dose for DM2 patients, and training on breathing exercises for COPD patients). Conclusions: Older individuals in these three groups seem receptive to technology in disease management. mHealth tools, incorporating both common and disease-specific features and addressing different chronic patients, and also being personalized at the same time, could be cost-saving and useful adjuncts in routine clinical care to improve self-management.

Digital surveillance in a pandemic response: What bioethics ought to learn from Indigenous perspectives.

Our paper interrogates the ethics of digital pandemic surveillance from Indigenous perspectives. The COVID-19 pandemic has shown that Indigenous peoples are among the communities most negatively affected by pandemic infectious disease spread. Similarly to other racialized subpopulations, Indigenous people have faced strikingly high mortality rates from COVID-19 owing to structural marginalization and related comorbidities, and these high rates have been exacerbated by past and present colonial dominance. At the same time, digital pandemic surveillance technologies, which have been promoted as effective tools for mitigating a pandemic, carry risks for Indigenous subpopulations that warrant an urgent and thorough investigation. Building on decolonial scholarship and debates about Indigenous data sovereignty, we argue that should Indigenous communities wish to implement digital pandemic surveillance, then they must have ownership over these technologies, including agency over their own health data, how data are collected and stored, and who will have access to the data. Ideally, these tools should be designed by Indigenous peoples themselves to ensure compatibility with Indigenous cultures, ethics and languages and the protection of Indigenous lives, health and wellbeing.

Inequities in Health Care Services Caused by the Adoption of Digital Health Technologies: Scoping Review.

BACKGROUND: Digital health technologies (ie, the integration of digital technology and health information) aim to increase the efficiency of health care delivery; they are rapidly adapting to health care contexts to provide improved medical services for citizens. However, contrary to expectations, their rapid adoption appears to have led to health inequities, with differences in health conditions or inequality in the distribution of health care resources among different populations. OBJECTIVE: This scoping review aims to identify and describe the inequities of health care services brought about by the adoption of digital health technologies. The factors influencing such inequities, as well as the corresponding countermeasures to ensure health equity among different groups of citizens, were also studied. METHODS: Primary studies and literature, including articles and reviews, published in English between 1990 and 2020 were retrieved using appropriate search strategies across the following three electronic databases: Clarivate Analytics' Web of Science, PubMed, and Scopus. Data management was performed by two authors (RY and WZ) using Thomson Endnote (Clarivate Analytics, Inc), by systematically screening and identifying eligible articles for this study. Any conflicts of opinion were resolved through discussions with the corresponding author. A qualitative descriptive synthesis was performed to determine the outcomes of this scoping review. RESULTS: A total of 2325 studies were collected during the search process, of which 41 (1.76%) papers were identified for further analysis. The quantity of literature increased until 2016, with a peak in 2020. The United States, the United Kingdom, and Norway ranked among the top 3 countries for publication output. Health inequities caused by the adoption of digital health technologies in health care services can be reflected in the following two dimensions: the inability of citizens to obtain and adopt technology and the different disease outcomes found among citizens under technical intervention measures. The factors that influenced inequities included age, race, region, economy, and education level, together with health conditions and eHealth literacy. Finally, action can be taken to alleviate inequities in the future by government agencies and medical institutions (eg, establishing national health insurance), digital health technology providers (eg, designing high-quality tools), and health care service recipients (eg, developing skills to access digital technologies). CONCLUSIONS: The application of digital health technologies in health care services has caused inequities to some extent. However, existing research has certain limitations. The findings provide a comprehensive starting point for future research, allowing for further investigation into how digital health technologies may influence the unequal distribution of health care services. The interaction between individual subjective factors as well as social support and influencing factors should be included in future studies. Specifically, access to and availability of digital health technologies for socially disadvantaged groups should be of paramount importance.

What are Digital Public Health Interventions? First Steps Toward a Definition and an Intervention Classification Framework.

Digital public health is an emerging field in population-based research and practice. The fast development of digital technologies provides a fundamentally new understanding of improving public health by using digitalization, especially in prevention and health promotion. The first step toward a better understanding of digital public health is to conceptualize the subject of the assessment by defining what digital public health interventions are. This is important, as one cannot evaluate tools if one does not know what precisely an intervention in this field can be. Therefore, this study aims to provide the first definition of digital public health interventions. We will merge leading models for public health functions by the World Health Organization, a framework for digital health technologies by the National Institute for Health and Care Excellence, and a user-centered approach to intervention development. Together, they provide an overview of the functions and areas of use for digital public health interventions. Nevertheless, one must keep in mind that public health functions can differ among different health care systems, limiting our new framework's universal validity. We conclude that a digital public health intervention should address essential public health functions through digital means. Furthermore, it should include members of the target group in the development process to improve social acceptance and achieve a population health impact.

Assessment of Clinical Information Quality in Digital Health Technologies: International eDelphi Study.

BACKGROUND: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs. OBJECTIVE: This study explored clinicians' perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework. METHODS: We used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions. RESULTS: Thirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity. CONCLUSIONS: The CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-057430.

Digital Approaches to Automated and Machine Learning Assessments of Hearing: Scoping Review.

BACKGROUND: Hearing loss affects 1 in 5 people worldwide and is estimated to affect 1 in 4 by 2050. Treatment relies on the accurate diagnosis of hearing loss; however, this first step is out of reach for >80% of those affected. Increasingly automated approaches are being developed for self-administered digital hearing assessments without the direct involvement of professionals. OBJECTIVE: This study aims to provide an overview of digital approaches in automated and machine learning assessments of hearing using pure-tone audiometry and to focus on the aspects related to accuracy, reliability, and time efficiency. This review is an extension of a 2013 systematic review. METHODS: A search across the electronic databases of PubMed, IEEE, and Web of Science was conducted to identify relevant reports from the peer-reviewed literature. Key information about each report's scope and details was collected to assess the commonalities among the approaches. RESULTS: A total of 56 reports from 2012 to June 2021 were included. From this selection, 27 unique automated approaches were identified. Machine learning approaches require fewer trials than conventional threshold-seeking approaches, and personal digital devices make assessments more affordable and accessible. Validity can be enhanced using digital technologies for quality surveillance, including noise monitoring and detecting inconclusive results. CONCLUSIONS: In the past 10 years, an increasing number of automated approaches have reported similar accuracy, reliability, and time efficiency as manual hearing assessments. New developments, including machine learning approaches, offer features, versatility, and cost-effectiveness beyond manual audiometry. Used within identified limitations, automated assessments using digital devices can support task-shifting, self-care, telehealth, and clinical care pathways.

Internet use and need for digital health technology among the elderly: a cross-sectional survey in China.

BACKGROUND: China is becoming an aging society at the fastest pace in history, and there are a large number of empty nesters in the country. With economic and social development, internal support systems among families are gradually weakening. Supporting the elderly is thus emerging as a significant issue, and promoting digital health technologies is an effective way to help address it. Encouraging the application of Internet to elderly care and Internet use among the elderly are important means of promoting digital health technologies. This paper examines the current state of the use of the Internet by the elderly and factors influencing it (including physical, psychological, and social) as well as demand among the elderly for smart services. METHODS: A total of 669 subjects over the age of 60 years were randomly selected from 13 cities in Heilongjiang province and surveyed using questionnaires from May 1 to July 31, 2018. The questionnaires were collected for descriptive statistics, the chi-square test, and the analysis of influential factors. RESULTS: Of the people surveyed, 38.6% used the Internet. Their favorite online activity was online dating (74.2%), and the health information they obtained through the Internet was mainly related to diet (63.1%) and exercise (47.1%). The subjects demanded smart bracelets (MD = 2.80) and emergency callers (MD = 2.77). Gender, age, education, monthly income, quality of life, number of friends, and social participation were found to have an impact on Internet use. CONCLUSIONS: More measures are needed to reduce barriers to the use of the Internet and promote digital health technologies. The society, equipment manufacturers, and family members of the elderly should work together to enable them to reap the benefits of online technologies.

Barriers and Enablers to Adoption of Digital Health Interventions to Support the Implementation of Dietary Guidelines in Early Childhood Education and Care: Cross-Sectional Study.

BACKGROUND: Few Australian childcare centers provide foods consistent with sector dietary guidelines. Digital health technologies are a promising medium to improve the implementation of evidence-based guidelines in the setting. Despite being widely accessible, the population-level impact of such technologies has been limited due to the lack of adoption by end users. OBJECTIVE: This study aimed to assess in a national sample of Australian childcare centers (1) intentions to adopt digital health interventions to support the implementation of dietary guidelines, (2) reported barriers and enablers to the adoption of digital health interventions in the setting, and (3) barriers and enablers associated with high intentions to adopt digital health interventions. METHODS: A cross-sectional telephone or online survey was undertaken with 407 childcare centers randomly sampled from a publicly available national register in 2018. Center intentions to adopt new digital health interventions to support dietary guideline implementation in the sector were assessed, in addition to perceived individual, organizational, and contextual factors that may influence adoption based on seven subdomains within the nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) of health and care technologies framework. A multiple-variable linear model was used to identify factors associated with high intentions to adopt digital health interventions. RESULTS: Findings indicate that 58.9% (229/389) of childcare centers have high intentions to adopt a digital health intervention to support guideline implementation. The changes needed in team interactions subdomain scored lowest, which is indicative of a potential barrier (mean 3.52, SD 1.30), with organization's capacity to innovate scoring highest, which is indicative of a potential enabler (mean 5.25, SD 1.00). The two NASSS subdomains of ease of the adoption decision (P<.001) and identifying work and individuals involved in implementation (P=.001) were significantly associated with high intentions to adopt digital health interventions. CONCLUSIONS: A substantial proportion of Australian childcare centers have high intentions to adopt new digital health interventions to support dietary guideline implementation. Given evidence of the effectiveness of digital health interventions, these findings suggest that such an intervention may make an important contribution to improving public health nutrition in early childhood.

Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial.

BACKGROUND: Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE: We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS: We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS: A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was -3.6 (SD 6.6) in the intervention group and -3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=-0.37; P=.72, 95% CI -3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=-2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS: The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733.

The Limits of Empowerment: How to Reframe the Role of mHealth Tools in the Healthcare Ecosystem.

This article highlights the limitations of the tendency to frame health- and wellbeing-related digital tools (mHealth technologies) as empowering devices, especially as they play an increasingly important role in the National Health Service (NHS) in the UK. It argues that mHealth technologies should instead be framed as digital companions. This shift from empowerment to companionship is advocated by showing the conceptual, ethical, and methodological issues challenging the narrative of empowerment, and by arguing that such challenges, as well as the risk of medical paternalism, can be overcome by focusing on the potential for mHealth tools to mediate the relationship between recipients of clinical advice and givers of clinical advice, in ways that allow for contextual flexibility in the balance between patiency and agency. The article concludes by stressing that reframing the narrative cannot be the only means for avoiding harm caused to the NHS as a healthcare system by the introduction of mHealth tools. Future discussion will be needed on the overarching role of responsible design.

Selecting digital health technologies for validation and piloting by healthcare providers: a decision-making perspective from ontario.

Digital health technologies (DHTs) such as health apps are rapidly emerging as a major disruptor of health care. Yet there is no well-established process of decision making for selecting DHTs that are worthy of investing resources in their validation to determine whether they are ready (safe, effective, and not too costly) for health related use. We report here on an Ontario-based initiative to support such decision making. Specifically, we developed a decision-making algorithm that uses approved criteria including the strategic direction of the health research institute and the hospital, and availability of resources. The Council of Academic Hospitals of Ontario has adapted our approach for other hospitals. We hope that other healthcare organizations, in and beyond Ontario, will consider this and alternative approaches, and that research will be conducted to evaluate such approaches.

Elements of Trust in Digital Health Systems: Scoping Review.

BACKGROUND: Information and communication technologies have long become prominent components of health systems. Rapid advances in digital technologies and data science over the last few years are predicted to have a vast impact on health care services, configuring a paradigm shift into what is now commonly referred to as digital health. Forecasted to curb rising health costs as well as to improve health system efficiency and safety, digital health success heavily relies on trust from professional end users, administrators, and patients. Yet, what counts as the building blocks of trust in digital health systems has so far remained underexplored. OBJECTIVE: The objective of this study was to analyze what relevant stakeholders consider as enablers and impediments of trust in digital health. METHODS: We performed a scoping review to map out trust in digital health. To identify relevant digital health studies, we searched 5 electronic databases. Using keywords and Medical Subject Headings, we targeted all relevant studies and set no boundaries for publication year to allow a broad range of studies to be identified. The studies were screened by 2 reviewers after which a predefined data extraction strategy was employed and relevant themes documented. RESULTS: Overall, 278 qualitative, quantitative, mixed-methods, and intervention studies in English, published between 1998 and 2017 and conducted in 40 countries were included in this review. Patients and health care professionals were the two most prominent stakeholders of trust in digital health; a third-health administrators-was substantially less prominent. Our analysis identified cross-cutting personal, institutional, and technological elements of trust that broadly cluster into 16 enablers (altruism, fair data access, ease of use, self-efficacy, sociodemographic factors, recommendation by other users, usefulness, customizable design features, interoperability, privacy, initial face-to-face contact, guidelines for standardized use, stakeholder engagement, improved communication, decreased workloads, and service provider reputation) and 10 impediments (excessive costs, limited accessibility, sociodemographic factors, fear of data exploitation, insufficient training, defective technology, poor information quality, inadequate publicity, time-consuming, and service provider reputation) to trust in digital health. CONCLUSIONS: Trust in digital health technologies and services depends on the interplay of a complex set of enablers and impediments. This study is a contribution to ongoing efforts to understand what determines trust in digital health according to different stakeholders. Therefore, it offers valuable points of reference for the implementation of innovative digital health services. Building on insights from this study, actionable metrics can be developed to assess the trustworthiness of digital technologies in health care.

Cancer Patients' Perspectives and Requirements of Digital Health Technologies: A Scoping Literature Review.

Digital health technologies have the potential to alleviate the increasing cancer burden. Incorporating patients' perspectives on digital health tools has been identified as a critical determinant for their successful uptake in cancer care. The main objective of this scoping review was to provide an overview of the existing evidence on cancer patients' perspectives and requirements for patient-facing digital health technologies. Three databases (CINAHL, MEDLINE, Science Direct) were searched and 128 studies were identified as eligible for inclusion. Web-based software/platforms, mobile or smartphone devices/applications, and remote sensing/wearable technologies employed for the delivery of interventions and patient monitoring were the most frequently employed technologies in cancer care. The abilities of digital tools to enable care management, user-friendliness, and facilitate patient-clinician interactions were the technological requirements predominantly considered as important by cancer patients. The findings from this review provide evidence that could inform future research on technology-associated parameters influencing cancer patients' decisions regarding the uptake and adoption of patient-facing digital health technologies.

Why Language Matters in Digital Endpoint Development: Harmonized Terminology as a Key Prerequisite for Evidence Generation.

Background: Developments in the field of digital measures and digitally derived endpoints demand greater attention on globally aligned approaches to enhance digital measure acceptance by regulatory authorities and health technology assessment (HTA) bodies for decision-making. In order to maximize the value of digital measures in global drug development programs and to ensure study teams and regulators are referring to the same items, greater alignment of concepts, definitions, and terminology is required. This is a fast-moving complex field; every day brings new technologies, algorithms, and possibilities. A common language is particularly important when working in multifunctional teams to ensure that there is a clear understanding of what is meant and understood. Summary: In the paper, the EFPIA digital endpoint joint subgroup reviews the challenges facing teams working to advance digital endpoints, where different terms are used to describe the same things, where common terms such as "monitoring" have significantly different meaning for different regulatory agencies, where the preface "e" to denote electronic is still used in some contexts, but the term "digital" is used in other, and where there is significant confusion as to what is understood by "raw" when it comes to data derived from digital health technologies. Key Message: The EFPIA subgroup is calling for an aligned lexicon. Alignment provides a more predictable path for development, validation, and use of the tools and measures used to collect digital endpoints supporting standardization and consistency in this new field of research, with the goal of increasing regulatory and payer harmonization and acceptance.