Health equity related challenges and experiences during the rapid implementation of virtual care during COVID-19: a multiple case study.

BACKGROUND: Virtual care quickly became of crucial importance to health systems around the world during the COVID-19 pandemic. Despite the potential of virtual care to enhance access for some communities, the scale and pace at which services were virtualized did not leave many organizations with sufficient time and resources to ensure optimal and equitable delivery of care for everyone. The objective of this paper is to outline the experiences of health care organizations rapidly implementing virtual care during the first wave of the COVID-19 pandemic and examine whether and how health equity was considered. METHODS: We used an exploratory, multiple case study approach involving four health and social service organizations providing virtual care services to structurally marginalized communities in the province of Ontario, Canada. We conducted semi-structured qualitative interviews with providers, managers, and patients to understand the challenges experienced by organizations and the strategies put in place to support health equity during the rapid virtualization of care. Thirty-eight interviews were thematically analyzed using rapid analytic techniques. RESULTS: Organizations experienced challenges related to infrastructure availability, digital health literacy, culturally appropriate approaches, capacity for health equity, and virtual care suitability. Strategies to support health equity included the provision of blended models of care, creation of volunteer and staff support teams, participation in community engagement and outreach, and securement of infrastructure for clients. We put our findings into the context of an existing framework conceptualizing access to health care and expand on what this means for equitable access to virtual care for structurally marginalized communities. CONCLUSION: This paper highlights the need to pay greater attention to the role of health equity in virtual care delivery and situate that conversation around existing inequitable structures in the health care system that are perpetuated when delivering care virtually. An equitable and sustainable approach to virtual care delivery will require applying an intersectionality lens on the strategies and solutions needed to address existing inequities in the system.

A "Do No Harm" Novel Safety Checklist and Research Approach to Determine Whether to Launch an Artificial Intelligence-Based Medical Technology: Introducing the Biological-Psychological, Economic, and Social (BPES) Framework.

Given the impact artificial intelligence (AI)-based medical technologies (hardware devices, software programs, and mobile apps) can have on society, debates regarding the principles behind their development and deployment are emerging. Using the biopsychosocial model applied in psychiatry and other fields of medicine as our foundation, we propose a novel 3-step framework to guide industry developers of AI-based medical tools as well as health care regulatory agencies on how to decide if a product should be launched-a "Go or No-Go" approach. More specifically, our novel framework places stakeholders' (patients, health care professionals, industry, and government institutions) safety at its core by asking developers to demonstrate the biological-psychological (impact on physical and mental health), economic, and social value of their AI tool before it is launched. We also introduce a novel cost-effective, time-sensitive, and safety-oriented mixed quantitative and qualitative clinical phased trial approach to help industry and government health care regulatory agencies test and deliberate on whether to launch these AI-based medical technologies. To our knowledge, our biological-psychological, economic, and social (BPES) framework and mixed method phased trial approach are the first to place the Hippocratic Oath of "Do No Harm" at the center of developers', implementers', regulators', and users' mindsets when determining whether an AI-based medical technology is safe to launch. Moreover, as the welfare of AI users and developers becomes a greater concern, our framework's novel safety feature will allow it to complement existing and future AI reporting guidelines.

The Complexity of Transferring Remote Monitoring and Virtual Care Technology Between Countries: Lessons From an International Workshop.

International deployment of remote monitoring and virtual care (RMVC) technologies would efficiently harness their positive impact on outcomes. Since Canada and the United Kingdom have similar populations, health care systems, and digital health landscapes, transferring digital health innovations between them should be relatively straightforward. Yet examples of successful attempts are scarce. In a workshop, we identified 6 differences that may complicate RMVC transfer between Canada and the United Kingdom and provided recommendations for addressing them. These key differences include (1) minority groups, (2) physical geography, (3) clinical pathways, (4) value propositions, (5) governmental priorities and support for digital innovation, and (6) regulatory pathways. We detail 4 broad recommendations to plan for sustainability, including the need to formally consider how highlighted country-specific recommendations may impact RMVC and contingency planning to overcome challenges; the need to map which pathways are available as an innovator to support cross-country transfer; the need to report on and apply learnings from regulatory barriers and facilitators so that everyone may benefit; and the need to explore existing guidance to successfully transfer digital health solutions while developing further guidance (eg, extending the nonadoption, abandonment, scale-up, spread, sustainability framework for cross-country transfer). Finally, we present an ecosystem readiness checklist. Considering these recommendations will contribute to successful international deployment and an increased positive impact of RMVC technologies. Future directions should consider characterizing additional complexities associated with global transfer.

Understanding Decision-Making in the Adoption of Digital Health Technology: The Role of Behavioral Economics' Prospect Theory.

The decision to accept or reject new digital health technologies remains an ongoing challenge among health care patients, providers, technology companies, and policymakers. Over the past few decades, interest in understanding the choice to adopt technology has led to the development of numerous theories and models. In 1979, however, psychologists Kahneman and Tversky published their seminal research article that has pioneered the field of behavioral economics. They named their model the prospect theory and used it to explain decision-making behaviors under conditions of risk and uncertainty as well as to provide an understanding of why individuals may make irrational or inconsistent choices. Although the prospect theory has been used to explain decision-making in economics, law, political science, and clinically, at the individual level, its application to understanding choice in the adoption of digital health technology has not been explored. Herein, we discuss how the main components of the prospect theory's editing phase (framing effect) and evaluation phase (value function and weighting function) can provide valuable insight on why health care patients, providers, technology companies, and policymakers may decide to accept or reject digital health technologies.

Digital Health Interventions for Depression and Anxiety Among People With Chronic Conditions: Scoping Review.

BACKGROUND: Chronic conditions are characterized by their long duration (≥1 year), need for ongoing medical attention, and limitations in activities of daily living. These can often co-occur with depression and anxiety as common and detrimental comorbidities among the growing population living with chronic conditions. Digital health interventions (DHIs) hold promise in overcoming barriers to accessing mental health support for these individuals; however, the design and implementation of DHIs for depression and anxiety in people with chronic conditions are yet to be explored. OBJECTIVE: This study aimed to explore what is known in the literature regarding DHIs for the prevention, detection, or treatment of depression and anxiety among people with chronic conditions. METHODS: A scoping review of the literature was conducted using the Arksey and O'Malley framework. Searches of the literature published in 5 databases between 1990 and 2019 were conducted in April 2019 and updated in March 2021. To be included, studies must have described a DHI tested with, or designed for, the prevention, detection, or treatment of depression or anxiety in people with common chronic conditions (arthritis, asthma, diabetes mellitus, heart disease, chronic obstructive pulmonary disease, cancer, stroke, and Alzheimer disease or dementia). Studies were independently screened by 2 reviewers against the inclusion and exclusion criteria. Both quantitative and qualitative data were extracted, charted, and synthesized to provide a descriptive summary of the trends and considerations for future research. RESULTS: Database searches yielded 11,422 articles across the initial and updated searches, 53 (0.46%) of which were included in this review. DHIs predominantly sought to provide treatment (44/53, 83%), followed by detection (5/53, 9%) and prevention (4/53, 8%). Most DHIs were focused on depression (36/53, 68%), guided (32/53, 60%), tailored to chronic physical conditions (19/53, 36%), and delivered through web-based platforms (20/53, 38%). Only 2 studies described the implementation of a DHI. CONCLUSIONS: As a growing research area, DHIs offer the potential to address the gap in care for depression and anxiety among people with chronic conditions; however, their implementation in standard care is scarce. Although stepped care has been identified as a promising model to implement efficacious DHIs, few studies have investigated the use of DHIs for depression and anxiety among chronic conditions using such models. In developing stepped care, we outlined DHI tailoring, guidance, and intensity as key considerations that require further research.

Operationalizing and Evaluating Synchronous Virtual Group Health Interventions: Wide-Scale Implementation at a Tertiary Care Academic Hospital.

Group-based health interventions are an important component of health promotion and management. To provide continuity of care throughout the COVID-19 pandemic, our institution undertook a rapid pivot to delivering group-based health interventions via a videoconferencing service which was securely embedded into both the electronic medical record and the patient portal to sustainably address immediate health service delivery needs during the pandemic and beyond. In this paper, we (1) describe the institutionally driven operationalization of a system to provide integrated synchronous video group visits across our hospital and (2) present a proposed strategy to comprehensively evaluate outcomes regarding their implementation, quality, and impact. Lessons for other institutions and the potential future role of synchronous video group visits to enhance how care can be scaled for delivery are discussed.

Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study.

BACKGROUND: Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on telemonitoring for this population. OBJECTIVE: This randomized controlled trial and embedded qualitative study aims to evaluate the impact on and experiences of patients and health care providers (HCPs) using a telemonitoring system with decision support to manage patients with complex conditions, including those with multiple chronic conditions, compared with the standard of care. METHODS: A pragmatic, unblinded, 6-month randomized controlled trial sought to recruit 146 patients with ≥1 diagnosis of heart failure (HF), uncontrolled hypertension (HT), and insulin-requiring diabetes mellitus (DM) from outpatient specialty settings in Toronto, Ontario, Canada. Participants were randomized into the control and telemonitoring groups, with the latter being instructed to take readings relevant to their conditions. The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status (36-Item Short Form Health Survey questionnaire). Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported health service use. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group was interviewed about their experiences. RESULTS: A total of 96 patients were recruited and randomized. Recruitment was terminated early because of implementation challenges and the onset of the COVID-19 pandemic. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of patients with HF found improvements in self-care maintenance (P=.04) and physical quality of life (P=.046). Opinions expressed by the 5 HCPs and 13 patients who were interviewed differed based on the monitored conditions. Although patients with HF reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care and the design of the decision support, whereby fluctuations in the status of HT and DM typically required less urgent interventions compared with patients with HF. CONCLUSIONS: We recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary but not sufficient components of such programs for patients with complex conditions and lower acuity. We conclude that telemonitoring for patients with complex conditions or within multidisciplinary care settings may be best operationalized through nurse-led models of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.8367.

Virtual Primary Care Implementation During COVID-19 in High-Income Countries: A Scoping Review.

Background: The purpose of this scoping review was to map the challenges, strategies, and lessons learned from high-income countries that can be mobilized to inform decision-makers on how to best implement virtual primary care services during and after the COVID-19 pandemic. Findings of our scoping review identified the barriers and strategies within the Quadruple Aim components, which may prove to be an effective implementation strategy for virtual care adoption in primary care settings. Materials and Methods:The two concepts of virtual care and COVID-19 were searched in MEDLINE, EMBASE, and CINAHL on August 10, 2020, and Scopus was searched on August 15, 2020. The database searches returned 10,549 citations and an additional 766 citations were retrieved from searching the citations from the reference lists of articles that met all inclusion criteria. A total of 1,260 full-text articles were reviewed of which 38 articles met the eligibility criteria for inclusion in the review. Results: Seven key barriers and strategies were identified for the implementation of virtual primary care. Of the 38 articles included, the key barriers identified were equitable access to care (n = 20; 53%), lack of funding for virtual care (n = 14; 37%), negative patient and clinician perception (n = 11, 29%), lack of regulatory policies (n = 10, 26%), inadequate clinical workflows (n = 9, 21), lack of virtual care infrastructure (n = 8, 21%), and insufficient virtual care training and education (n = 5, 13%). Strategies included the following: increased funding (n = 15, 39%), improving clinical workflows (n = 13, 34%), appropriate education and training (n = 11, 29%), improving virtual care infrastructure and patient equity (n = 7, 18%), establishing regulatory policies (n = 5, 13%), and improving patient and clinician perceptions (n = 3, 7%). Conclusions: As many countries enter potential subsequent waves of the COVID-19 pandemic, applying early lessons learned to mitigate implementation barriers can help with the transition to equitable and appropriate virtual primary care services.

Adoption of COVID-19 Contact Tracing Apps: A Balance Between Privacy and Effectiveness.

With the relative ubiquity of smartphones, contact tracing and exposure notification apps have been looked to as novel methods to help reduce the transmission of COVID-19. Many countries have created apps that lie across a spectrum from privacy-first approaches to those that have very few privacy measures. The level of privacy incorporated into an app is largely based on the societal norms and values of a particular country. Digital health technologies can be highly effective and preserve privacy at the same time, but in the case of contact tracing and exposure notification apps, there is a trade-off between increased privacy measures and the effectiveness of the app. In this article, examples from various countries are used to highlight how characteristics of contract tracing and exposure notification apps contribute to the perceived levels of privacy awarded to citizens and how this impacts an app's effectiveness. We conclude that finding the right balance between privacy and effectiveness, while critical, is challenging because it is highly context-specific.

The Use of Information and Communication Technologies by Sex Workers to Manage Occupational Health and Safety: Scoping Review.

BACKGROUND: In many countries, sex work is criminalized, driving sex work underground and leaving sex workers vulnerable to a number of occupational health and safety risks, including violence, assault, and robbery. With the advent of widely accessible information and communication technologies (ICTs), sex workers have begun to use electronic occupational health and safety tools to mitigate these risks. OBJECTIVE: This study aims to explore the use of ICTs by sex workers for managing occupational health and safety risks and strategies for reducing these risks. This paper aims to answer the following question: what is known about sex workers' use of ICTs in the delivery of occupational health and safety strategies? METHODS: A literature review following the methodological framework for scoping reviews was conducted to analyze studies describing the use of ICTs by sex workers to mitigate occupational health and safety risks. Experimental, observational, and descriptive studies, as well as protocol papers, were included in this scoping review. RESULTS: Of the 2477 articles initially identified, 41 (1.66%) met the inclusion criteria. Of these studies, 71% (29/41) were published between 2015 and 2019. In these studies, the internet was the predominant ICT (24/41, 58%), followed by text messaging (10/41, 24%) and assorted communication technologies associated with mobile phones without internet access (7/41, 17%; eg, voice mail). In 56% (23/41) of the studies, sex workers located in high-income countries created occupational health and safety strategies (eg, bad date lists) and shared them through the internet. In 24% (10/41) of the studies, mostly in low- and middle-income countries, organizations external to sex work developed and sent (through text messages) occupational health and safety strategies focused on HIV. In 20% (8/41) of the studies, external organizations collaborated with the sex worker community in the development of occupational health and safety strategies communicated through ICTs; through this collaboration, concerns other than HIV (eg, mental health) emerged. CONCLUSIONS: Although there has been an increase in the number of studies on the use of ICTs by sex workers for managing occupational health and safety over the past 5 years, knowledge of how to optimally leverage ICTs for this purpose remains scarce. Recommendations for expanding the use of ICTs by sex workers for occupational health and safety include external organizations collaborating with sex workers in the design of ICT interventions to mitigate occupational health and safety risks; to examine whether ICTs used in low- and middle-income countries would have applications in high-income countries as a substitute to the internet for sharing occupational health and safety strategies; and to explore the creation of innovative, secure, web-based communities that use existing or alternative digital technologies that could be used by sex workers to manage their occupational health and safety.

Expanding Telemonitoring in a Virtual World: A Case Study of the Expansion of a Heart Failure Telemonitoring Program During the COVID-19 Pandemic.

BACKGROUND: To minimize the spread and risk of a COVID-19 outbreak, societal norms have been challenged with respect to how essential services are delivered. With pressures to reduce the number of in-person ambulatory visits, innovative models of telemonitoring have been used during the pandemic as a necessary alternative to support access to care for patients with chronic conditions. The pandemic has led health care organizations to consider the adoption of telemonitoring interventions for the first time, while others have seen existing programs rapidly expand. OBJECTIVE: At the Toronto General Hospital in Ontario, Canada, the rapid expansion of a telemonitoring program began on March 9, 2020, in response to COVID-19. The objective of this study was to understand the experiences related to the expanded role of a telemonitoring program under the changing conditions of the pandemic. METHODS: A single-case qualitative study was conducted with 3 embedded units of analysis. Semistructured interviews probed the experiences of patients, clinicians, and program staff from the Medly telemonitoring program at a heart function clinic in Toronto, Canada. Data were analyzed using inductive thematic analysis as well as Eakin and Gladstone's value-adding approach to enhance the analytic interpretation of the study findings. RESULTS: A total of 29 participants were interviewed, including patients (n=16), clinicians (n=9), and operational staff (n=4). Four themes were identified: (1) providing care continuity through telemonitoring; (2) adapting telemonitoring operations for a more virtual health care system; (3) confronting virtual workflow challenges; and (4) fostering a meaningful patient-provider relationship. Beyond supporting virtual visits, the program's ability to provide a more comprehensive picture of the patient's health was valued. However, issues relating to the lack of system integration and alert-driven interactions jeopardized the perceived sustainability of the program. CONCLUSIONS: With the reduction of in-person visits during the pandemic, virtual services such as telemonitoring have demonstrated significant value. Based on our study findings, we offer recommendations to proactively adapt and scale telemonitoring programs under the changing conditions of an increasingly virtual health care system. These include revisiting the scope and expectations of telemedicine interventions, streamlining virtual patient onboarding processes, and personalizing the collection of patient information to build a stronger virtual relationship and a more holistic assessment of patient well-being.

Exploring perspectives, preferences and needs of a telemonitoring program for women at high risk for preeclampsia in a tertiary health facility of Karachi: a qualitative study protocol.

BACKGROUND: In Pakistan, deaths from preeclampsia/eclampsia (PE/E) represent one-third of maternal deaths reported at tertiary care hospitals. To reduce the morbidity and mortality associated with PE/E, an accessible strategy is to support pregnant women at high risk for preeclampsia (HRPE) by closely monitoring their blood pressures at home (i.e., telemonitoring) for the earliest signs of preeclampsia. This could lead to the earliest possible detection of high blood pressure, resulting in early intervention such as through medications, hospitalization, or delivery of the baby. The study aims to explore the perspectives, preferences and needs of telemonitoring (TM) for pregnant women at HRPE in Karachi, to inform future implementation strategies. METHODS: The study will employ an exploratory qualitative research design. The study will be conducted at the Jinnah Postgraduate Medical Centre (JPMC) hospital and Aga Khan University Hospital (AKUH) in Karachi, Sindh, Pakistan. Data will be collected through key-informant interviews (KIIs) and in-depth patient interviews (IDPIs). IDPIs will be conducted with the pregnant women at HRPE who are visiting the out-patient department/ antenatal clinics of JPMC hospital for antenatal check-ups and immunizations. KIIs will be conducted with the obstetricians, Maternal, neonatal and child health (MNCH) specialists and health care providers at JPMC, as well as TM experts from Karachi. Study data will be analyzed through conventional content analysis. Interviews are anticipated to begin in April 2020 and to be completed during the summer of 2020. DISCUSSION: This is the first study to explore the use of TM program for pregnant women at HRPE in a tertiary health facility in Karachi. The research will help explore perceived benefits associated with the use of a TM program alongside potential facilitators and barriers that may help inform the future implementation of a TM program for pregnant women at HRPE in Karachi.

Mobile Health for Perinatal Depression and Anxiety: Scoping Review.

BACKGROUND: The perinatal period is a vulnerable time during which depression and anxiety commonly occur. If left untreated or undertreated, there may be significant adverse effects; therefore, access to rapid, effective treatment is essential. Treatments for mild-to-moderate symptoms according to a stepped-care approach involve psychoeducation, peer support, and psychological therapy, all of which have been shown to be efficaciously delivered through digital means. Women experience significant barriers to care because of system- and individual-level factors, such as cost, accessibility, and availability of childcare. The use of mobile phones is widespread in this population, and the delivery of mental health services via mobile phones has been suggested as a means of reducing barriers. OBJECTIVE: This study aimed to understand the extent, range, and nature of mobile health (mHealth) tools for prevention, screening, and treatment of perinatal depression and anxiety in order to identify gaps and inform opportunities for future work. METHODS: Using a scoping review framework, 4 databases were searched for terms related to mobile phones, perinatal period, and either depression or anxiety. A total of 477 unique records were retrieved, 81 of which were reviewed by full text. Peer-reviewed publications were included if they described the population as women pregnant or up to 1 year postpartum and a tool explicitly delivered via a mobile phone for preventing, screening, or treating depression or anxiety. Studies published in 2007 or earlier, not in English, or as case reports were excluded. RESULTS: A total of 26 publications describing 22 unique studies were included (77% published after 2017). mHealth apps were slightly more common than texting-based interventions (12/22, 54% vs 10/22, 45%). Most tools were for either depression (12/22, 54%) or anxiety and depression (9/22, 41%); 1 tool was for anxiety only (1/22, 4%). Interventions starting in pregnancy and continuing into the postpartum period were rare (2/22, 9%). Tools were for prevention (10/22, 45%), screening (6/22, 27%), and treatment (6/22, 27%). Interventions delivered included psychoeducation (16/22, 73%), peer support (4/22, 18%), and psychological therapy (4/22, 18%). Cost was measured in 14% (3/22) studies. CONCLUSIONS: Future work in this growing area should incorporate active psychological treatment, address continuity of care across the perinatal period, and consider clinical sustainability to realize the potential of mHealth.

Evaluation of a Heart Failure Telemonitoring Program Through a Microsimulation Model: Cost-Utility Analysis.

BACKGROUND: Heart failure (HF) is a major public health issue in Canada that is associated with high prevalence, morbidity, and mortality rates and high financial and social burdens. Telemonitoring (TM) has been shown to improve all-cause mortality and hospitalization rates in patients with HF. The Medly program is a TM intervention integrated as standard of care at a large Canadian academic hospital for ambulatory patients with HF that has been found to improve patient outcomes. However, the cost-effectiveness of the Medly program is yet to be determined. OBJECTIVE: This study aims to conduct a cost-utility analysis of the Medly program compared with the standard of care for HF in Ontario, Canada, from the perspective of the public health care payer. METHODS: Using a microsimulation model, individual patient data were simulated over a 25-year time horizon to compare the costs and quality-adjusted life years (QALYs) between the Medly program and standard care for patients with HF treated in the ambulatory care setting. Data were sourced from a Medly Program Evaluation study and literature to inform model parameters, such as Medly's effectiveness in reducing mortality and hospitalizations, health care and intervention costs, and model transition probabilities. Scenario analyses were conducted in relation to HF severity and TM deployment models. One-way deterministic effectiveness analysis and probabilistic sensitivity analysis were performed to explore the impact on the results of uncertainty in model parameters. RESULTS: The Medly program was associated with an average total cost of Can $102,508 (US $77,626) per patient and total QALYs of 5.51 per patient compared with the average cost of Can $97,497 (US $73,831) and QALYs of 4.95 per patient in the Standard Care Group. This led to an incremental cost of Can $5011 (US $3794) and incremental QALY of 0.566, resulting in an incremental cost-effectiveness ratio of Can $8850 (US $6701)/QALY. Cost-effectiveness improved in relation to patients with advanced HF and with deployment models in which patients used their own equipment. Baseline and alternative scenarios consistently showed probabilities of cost-effectiveness greater than 85% at a willingness-to-pay threshold of Can $50,000 (US $37,718). Although the results showed some sensitivity to assumptions about effectiveness parameters, the intervention was found to remain cost-effective. CONCLUSIONS: The Medly program for patients with HF is cost-effective compared with standard care using commonly reported willingness-to-pay thresholds. This study provides evidence for decision makers on the use of TM for HF, supports the use of a nurse-led model of TM that embeds clinically validated algorithms, and informs the use of economic modeling for future evaluations of early-stage health informatics technology.

Outcomes of a Heart Failure Telemonitoring Program Implemented as the Standard of Care in an Outpatient Heart Function Clinic: Pretest-Posttest Pragmatic Study.

BACKGROUND: Telemonitoring (TM) can improve heart failure (HF) outcomes by facilitating patient self-care and clinical decisions. The Medly program enables patients to use a mobile phone to record daily HF readings and receive personalized self-care messages generated by a clinically validated algorithm. The TM system also generates alerts, which are immediately acted upon by the patients' existing care team. This program has been operating for 3 years as part of the standard of care in an outpatient heart function clinic in Toronto, Canada. OBJECTIVE: This study aimed to evaluate the 6-month impact of this TM program on health service utilization, clinical outcomes, quality of life (QoL), and patient self-care. METHODS: This pragmatic quality improvement study employed a pretest-posttest design to compare 6-month outcome measures with those at program enrollment. The primary outcome was the number of HF-related hospitalizations. Secondary outcomes included all-cause hospitalizations, emergency department visits (HF related and all cause), length of stay (HF related and all cause), and visits to the outpatient clinic. Clinical outcomes included bloodwork (B-type natriuretic peptide [BNP], creatinine, and sodium), left ventricular ejection fraction, and predicted survival score using the Seattle Heart Failure Model. QoL was measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the 5-level EuroQol 5-dimensional questionnaire. Self-care was measured using the Self-Care of Heart Failure Index (SCHFI). The difference in outcome scores was analyzed using negative binomial distribution and Poisson regressions for the health service utilization outcomes and linear regressions for all other outcomes to control for key demographic and clinical variables. RESULTS: Available data for 315 patients enrolled in the TM program between August 2016 and January 2019 were analyzed. A 50% decrease in HF-related hospitalizations (incidence rate ratio [IRR]=0.50; P<.001) and a 24% decrease in the number of all-cause hospitalizations (IRR=0.76; P=.02) were found when comparing the number of events 6 months after program enrollment with the number of events 6 months before enrollment. With regard to clinical outcomes at 6 months, a 59% decrease in BNP values was found after adjusting for control variables. Moreover, 6-month MLHFQ total scores were 9.8 points lower than baseline scores (P<.001), representing a clinically meaningful improvement in HF-related QoL. Similarly, the MLHFQ physical and emotional subscales showed a decrease of 5.4 points (P<.001) and 1.5 points (P=.04), respectively. Finally, patient self-care after 6 months improved as demonstrated by a 7.8-point (P<.001) and 8.5-point (P=.01) increase in the SCHFI maintenance and management scores, respectively. No significant changes were observed in the remaining secondary outcomes. CONCLUSIONS: This study suggests that an HF TM program, which provides patients with self-care support and active monitoring by their existing care team, can reduce health service utilization and improve clinical, QoL, and patient self-care outcomes.

The Service of Research Analytics to Optimize Digital Health Evidence Generation: Multilevel Case Study.

BACKGROUND: The widespread adoption of digital health interventions for chronic disease self-management has catalyzed a paradigm shift in the selection of methodologies used to evidence them. Recently, the application of digital health research analytics has emerged as an efficient approach to evaluate these data-rich interventions. However, there is a growing mismatch between the promising evidence base emerging from analytics mediated trials and the complexity of introducing these novel research methods into evaluative practice. OBJECTIVE: This study aimed to generate transferable insights into the process of implementing research analytics to evaluate digital health interventions. We sought to answer the following two research questions: (1) how should the service of research analytics be designed to optimize digital health evidence generation? and (2) what are the challenges and opportunities to scale, spread, and sustain this service in evaluative practice? METHODS: We conducted a qualitative multilevel embedded single case study of implementing research analytics in evaluative practice that comprised a review of the policy and regulatory climate in Ontario (macro level), a field study of introducing a digital health analytics platform into evaluative practice (meso level), and interviews with digital health innovators on their perceptions of analytics and evaluation (microlevel). RESULTS: The practice of research analytics is an efficient and effective means of supporting digital health evidence generation. The introduction of a research analytics platform to evaluate effective engagement with digital health interventions into a busy research lab was ultimately accepted by research staff, became routinized in their evaluative practice, and optimized their existing mechanisms of log data analysis and interpretation. The capacity for research analytics to optimize digital health evaluations is highest when there is (1) a collaborative working relationship between research client and analytics service provider, (2) a data-driven research agenda, (3) a robust data infrastructure with clear documentation of analytic tags, (4) in-house software development expertise, and (5) a collective tolerance for methodological change. CONCLUSIONS: Scientific methods and practices that can facilitate the agile trials needed to iterate and improve digital health interventions warrant continued implementation. The service of research analytics may help to accelerate the pace of digital health evidence generation and build a data-rich research infrastructure that enables continuous learning and evaluation.

Nonpublication Rates and Characteristics of Registered Randomized Clinical Trials in Digital Health: Cross-Sectional Analysis.

BACKGROUND: Clinical trials are key to advancing evidence-based medical research. The medical research literature has identified the impact of publication bias in clinical trials. Selective publication for positive outcomes or nonpublication of negative results could misdirect subsequent research and result in literature reviews leaning toward positive outcomes. Digital health trials face specific challenges, including a high attrition rate, usability issues, and insufficient formative research. These challenges may contribute to nonpublication of the trial results. To our knowledge, no study has thus far reported the nonpublication rates of digital health trials. OBJECTIVE: The primary research objective was to evaluate the nonpublication rate of digital health randomized clinical trials registered in ClinicalTrials.gov. Our secondary research objective was to determine whether industry funding contributes to nonpublication of digital health trials. METHODS: To identify digital health trials, a list of 47 search terms was developed through an iterative process and applied to the "Title," "Interventions," and "Outcome Measures" fields of registered trials with completion dates between April 1, 2010, and April 1, 2013. The search was based on the full dataset exported from the ClinlicalTrials.gov database, with 265,657 trials entries downloaded on February 10, 2018, to allow publication of studies within 5 years of trial completion. We identified publications related to the results of the trials through a comprehensive approach that included an automated and manual publication-identification process. RESULTS: In total, 6717 articles matched the a priori search terms, of which 803 trials matched our latest completion date criteria. After screening, 556 trials were included in this study. We found that 150 (27%) of all included trials remained unpublished 5 years after their completion date. In bivariate analyses, we observed statistically significant differences in trial characteristics between published and unpublished trials in terms of the intervention target condition, country, trial size, trial phases, recruitment, and prospective trial registration. In multivariate analyses, differences in trial characteristics between published and unpublished trials remained statistically significant for the intervention target condition, country, trial size, trial phases, and recruitment; the odds of publication for non-US-based trials were significant, and these trials were 3.3 (95% CI 1.845-5.964) times more likely to be published than US-based trials. We observed a trend of 1.5 times higher nonpublication rates for industry-funded trials. However, the trend was not statistically significant. CONCLUSIONS: In the domain of digital health, 27% of registered clinical trials results are unpublished, which is lower than nonpublication rates in other fields. There are substantial differences in nonpublication rates between trials funded by industry and nonindustry sponsors. Further research is required to define the determinants and reasons for nonpublication and, more importantly, to articulate the impact and risk of publication bias in the field of digital health trials.

Implementation and preliminary effectiveness of a real-time pain management smartphone app for adolescents with cancer: A multicenter pilot clinical study.

BACKGROUND: Pain in adolescents with cancer (12-18 years) is common and negatively impacts health-related quality of life (HRQL). The Pain Squad+ smartphone app, which provides adolescents with real-time pain self-management support, was developed to address this issue. This study evaluated the implementation of the app to inform a future randomized controlled trial (RCT) and obtain treatment effect estimates for pain intensity, pain interference, HRQL, and self-efficacy. PROCEDURE: A one-group baseline/poststudy design with 40 adolescents recruited from two pediatric tertiary care centers was used. Baseline questionnaires were completed and adolescents used the app at least twice daily for 28 days, receiving algorithm-informed self-management advice depending on their reported pain. A nurse received alerts in response to sustained pain and contacted adolescents to assist in pain care. Poststudy questionnaires were completed. Descriptive analyses, with exploratory inferential testing conducted on health outcome data, were used to address study aims. RESULTS: Most (40/52; 77%) eligible adolescents participated. Two participants withdrew participation. Intervention fidelity was impacted by technical difficulties (occurring for 15% of participants) and a prolonged time for nurse contact in the event of sustained pain. Adherence to pain reporting was 68.8 ± 38.1%. Outcome measure completion rates were high and the intervention was acceptable to participants. Trends in improvements in pain intensity, pain interference, and HRQL were significant, with effect sizes of 0.23-0.67. CONCLUSIONS: Implementation of Pain Squad+ is feasible and the app appears to improve pain-related outcomes for adolescents with cancer. A multicenter RCT will be undertaken to examine app effectiveness.

The Effect of Using a Remote Patient Management Platform in Optimizing Guideline-Directed Medical Therapy in Heart Failure Patients: A Randomized Controlled Trial.

BACKGROUND: Guideline-directed medical therapy (GDMT) remains underutilized in patients with heart failure with reduced ejection fraction, leading to morbidity and mortality. OBJECTIVES: The Medly Titrate (Use of Telemonitoring to Facilitate Heart Failure Mediation Titration) study was an open-label, randomized controlled trial to determine whether remote medication titration for patients with heart failure with reduced ejection fraction was more effective than usual care (UC). METHODS: In this study, 108 patients were randomized to remote GDMT titration through the Medly heart failure program (n = 56) vs UC (n = 52). The primary outcome was the proportion of patients completing GDMT titration at 6 months. Secondary outcomes included the number of clinic visits and time required to achieve titration, patient health outcomes, and health care utilization, including urgent clinic/emergency department visits and hospitalization. RESULTS: At 6 months, GDMT titration was completed in 82.1% (95% CI: 71.2%-90.8%) of patients in the intervention arm vs 53.8% in UC (95% CI: 41.1%-67.7%; P = 0.001). Remote titration required fewer in-person (1.62 ± 1.09 vs 2.42 ± 1.65; P = 0.004) and virtual clinic visits (0.50 ± 1.08 vs 1.29 ± 1.86; P = 0.009) to complete titration. Median time to optimization was shorter with remote titration (3.42 months [Q1-Q3: 2.99-4.04 months] vs 5.47 months [Q1-Q3: 4.14-7.33 months]; P < 0.001). The number of urgent clinic/emergency department visits (incidence rate ratio of remote vs control groups: 0.90 [95% CI: 0.53-1.56]; P = 0.70) were similar between groups, with a reduction in all-cause hospitalization with remote titration (incidence rate ratio: 0.55 [95% CI: 0.31-0.97]; P = 0.042). CONCLUSIONS: Remote titration of GDMT in heart failure with reduced ejection fraction was effective, safe, feasible, and increased the proportion of patients achieving target doses, in a shorter period of time with no excess adverse events compared with UC. (Use of Telemonitoring to Facilitate Heart Failure Mediation Titration [Medly Titrate]; NCT04205513).

A Web-Based Peer-Patient Navigation Program (Compassionate Online Navigation to Enhance Care Transitions) for Youth Living With Childhood-Acquired Disabilities Transitioning From Pediatric to Adult Care: Qualitative Descriptive Study.

BACKGROUND: Studies have highlighted significant challenges associated with the transition from pediatric to adult health and social care services for youth living with childhood-acquired disabilities and their caregivers. Patient navigation has been proposed as an effective transitional care intervention. Better understanding of how patient navigation may support youth and their families during pediatric to adult care transitions is warranted. OBJECTIVE: This study aims to describe the preferred adaptations of an existing web-based platform from the perspectives of youth with childhood-onset disabilities and their family caregivers to develop a web-based peer-patient navigation program, Compassionate Online Navigation to Enhance Care Transitions (CONNECT). METHODS: A qualitative descriptive design was used. Participants included youth living with childhood-acquired disabilities (16/23, 70%) and their caregivers (7/23, 30%). Semistructured interviews and focus groups were conducted, digitally recorded, and transcribed. Thematic analysis was used to analyze the data and was facilitated through NVivo software (Lumivero). RESULTS: Participants desired a program that incorporated (1) self-directed learning, (2) a library of reliable health and community resources, and (3) emotional and social supports. On the basis of participants' feedback, CONNECT was deemed satisfactory, as it was believed that the program would help support appropriate transition care through the provision of trusted health-related information. Participants highlighted the need for options to optimize confidentiality in their health and social care and the choice to remain anonymous to other participants. CONCLUSIONS: Web-based patient navigation programs such as CONNECT may deliver peer support that can improve the quality and experience of care for youth, and their caregivers, transitioning from pediatric to adult care through personalized support, health care monitoring, and health and social care resources. Future studies are needed to test the feasibility, acceptability, usability, use, and effectiveness of CONNECT among youth with childhood-onset disabilities.