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Introduction: Digital health interventions may support physical activity among solid organ transplant recipients. These interventions should be designed with users in mind, including healthcare professionals who counsel transplant recipients on physical activity to ensure acceptance and to promote an optimal user experience. The purpose of this study was to explore the perspectives of health care providers on the features of digital health interventions that would be useful in the promotion, implementation, and maintenance of physical activity among solid organ transplant recipients. Methods: This qualitative, cross-sectional study used semistructured interviews that were conducted remotely, via videoconferencing software, with providers who worked with transplant recipients. Interviews were transcribed, and an iterative-inductive, thematic analysis was used to identify common themes. Data were coded using NVivo software. Findings: Thirteen providers participated in this study. Four main themes were identified: (a) physical activity and exercise features (eg, physical activity guidelines, and exercise instructions); (b) credibility; (c) self-management; and (d) user engagement. Potential barriers to using digital health interventions included staffing requirements, professional regulatory issues, cost, perceived low patient motivation to use, and lack of technological literacy or access. Discussion: Digital health interventions were perceived to be a potential adjunct to current physical activity counseling practices, and part of an innovative strategy to address identified barriers to physical activity participation in solid organ transplant recipients.

UNSTRUCTURED International deployment of remote monitoring and virtual care (RMVC) technologies would efficiently harness their positive impact on outcomes. Since Canada and the UK have similar populations, healthcare 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 six differences that may complicate RMVC transfer between Canada and the UK, and provide recommendations for addressing. These key differences include: 1) minority groups, (2) physical geography, (3) clinical pathways, (4) value propositions, (5) governmental priorities and support for digital innovation, (6) regulatory pathways. We detail four 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 explore existing guidance to successfully transfer digital health solutions while developing further guidance (e.g., extending the NASSS framework for cross-country transfer). Finally, we present an ecosystem readiness checklist. Considering these recommendations will contribute to successful international deployment and increased positive impact of RMVC technologies.

BACKGROUND Emerging adults living with type 1 diabetes (T1D) face a series of challenges with self-management and decreased health system engagement, leading to increased risk of acute complications and hospital admissions. Effective and scalable strategies are needed to support this population to transfer seamlessly from paediatric to adult care with sufficient self-management capability. While digital health interventions for T1D self-management are a promising strategy, it remains unclear which elements work, how, and for which group(s) of individuals. OBJECTIVE The present study aims to evaluate the design and implementation of a multi-component digital health intervention to support emerging adults living with T1D in real-world settings. Specifically, the objectives are to identify the intervention components and associated mechanisms that lead to improved user engagement and T1D healthcare transition experiences and determine the individual-level contextual factors that influence the implementation process. METHODS Embedded alongside a randomized controlled trial, this realist evaluation employs a sequential mixed-methods design to analyze data from multiple sources, including intervention usage data, patient-reported outcomes, and semi-structured interviews. In Step 1, we conducted a document analysis to develop a program theory that outlines the hypothesized relationships amongst individual-level contextual factors (C), intervention components and features (I), mechanisms (M), and target outcomes (O) with special attention paid to user engagement. In Step 2, we will conduct semi-structured interviews with the RCT intervention arm participants to validate the hypothesized C-I-M-O configurations. In Step 3, we will triangulate all sources of data using a Coincidence Analysis to identify the necessary combinations of conditions (i.e., factors, pathways, and context) that determine whether and how the desired outcomes are achieved and use these insights to refine the program theory. RESULTS For step 1 analysis, we have developed the initial program theory and the corresponding data collection plan. For step 2 analysis, participant enrollment for the randomized controlled trial started in January 2023. Participant enrollment for the present realist evaluation is anticipated to start in May 2023 and continue until we reach thematic saturation or achieve informational power. CONCLUSIONS Beyond contributing to knowledge on the multiple pathways that lead to successful engagement with a digital health intervention as well as target outcomes in T1D care transitions, embedding the realist evaluation alongside the trial may inform real-time intervention refinement to improve user engagement and transition experiences. The knowledge gained from this study may inform the design, implementation, and evaluation of future digital health interventions that aim to improve transition experiences.

BACKGROUND For individuals living with diabetes and its psychosocial comorbidities (eg, depression, anxiety, and distress), there remains limited access to interprofessional, integrated care that includes mental health support, education, and follow-up. Health technology, broadly defined as the application of organized knowledge or skill as software, devices, and systems to solve health problems and improve quality of life, is emerging as a means of addressing these gaps. There is thus a need to understand how such technologies are being used to support, educate, and help individuals living with co-occurring diabetes and mental health distress or disorder. OBJECTIVE The purpose of this scoping review was to (1) describe the literature on technology-enabled integrated interventions for diabetes and mental health; (2) apply frameworks from the Mental Health Commission of Canada and World Health Organization to elucidate the components, type, processes, and users of technology-enabled integrated interventions for diabetes and mental health; and (3) map the level of integration of interventions for diabetes and mental health. METHODS We searched 6 databases from inception to February 2022 for English-language, peer-reviewed studies of any design or type that used technology to actively support both diabetes and any mental health distress or disorder in succession or concurrently among people with diabetes (type 1 diabetes, type 2 diabetes, and gestational diabetes). Reviewers screened citations and extracted data including study characteristics and details about the technology and integration used. RESULTS We included 24 studies described in 38 publications. These studies were conducted in a range of settings and sites of care including both web-based and in-person settings. Studies were mostly website-based (n=13) and used technology for wellness and prevention (n=16) and intervention and treatment (n=15). The primary users of these technologies were clients and health care providers. All the included intervention studies (n=20) used technology for clinical integration, but only 7 studies also used the technology for professional integration. CONCLUSIONS The findings of this scoping review suggest that there is a growing body of literature on integrated care for diabetes and mental health enabled by technology. However, gaps still exist with how to best equip health care professionals with the knowledge and skills to offer integrated care. Future research is needed to continue to explore the purpose, level, and breadth of technology-enabled integration to facilitate an approach to overcome or address care fragmentation for diabetes and mental health and to understand how health technology can further drive the scale-up of innovative integrated interventions.

BACKGROUND Comprehensive models of survivorship care are necessary to improve access and coordination of care and to address the complexity of physical and psychosocial problems and long-term health needs experienced by patients following cancer treatment. Our group is building a nurse-led virtual clinic to support men living with prostate cancer (PCa) in the post-treatment follow-up phase of their survivorship journey. OBJECTIVE This paper presents our expert-informed, rules-based, survivorship algorithm to build a nurse-led model of survivorship care for prostate cancer survivors with “no evidence of disease” (Ned) to support more timely decision-making, enhanced safety and continuity of care. METHODS An initial rule-set was developed via a literature review and working groups with clinical experts across Canada (e.g., nurse experts, physician experts, scientists) (n=20), and patient partners (n=3). Algorithm priorities were defined through a multidisciplinary consensus meeting with clinical nurse specialists, nurse scientists, nurse practitioners, urologic oncologists, urologists, and radiation oncologists (n=17). The system was refined and validated using nominal group technique. RESULTS Four levels of alert classification were established, initiated by responses on the EPIC-CP survey, and mediated by changes in minimal clinically important different alert thresholds, alert history, clinical urgency with patient autonomy influencing clinical acuity. Patient autonomy was supported through tailored education as a first line of response, and alert escalation depending on a patient-initiated request for a nurse consultation. CONCLUSIONS The Ned algorithm is positioned to facilitate PCa nurse-led care models with a high nurse to patient ratio. This novel expert-informed PCa survivorship care algorithm contains a defined escalation pathway for clinically urgent symptoms while honoring patient preference. Though further validation is required through a pragmatic trial, we anticipate the Ned algorithm will support more timely decision-making, enhance continuity of care through automation of more frequent automated check points, while empowering patients to self-manage their symptoms more effectively than standard care. INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2020-045806

BackgroundThe prevalence of heart failure (HF) is increasing in Uganda. Ugandan patients with HF report receiving limited information about their illness, disease management, or empowerment to engage in self-care behaviors. Interventions targeted at improving HF self-care have been shown to improve patient quality of life and to reduce hospitalizations in high-income countries. However, such interventions remain underutilized in resource-limited settings like Uganda.ObjectiveTo develop a digital health intervention that enables improved self-care amongst HF patients in Uganda.MethodsWe implemented a user-centred design process to develop a self-care intervention entitled Medly Uganda. The ideation phase comprised a systematic scoping review and preliminary data collection amongst HF patients and clinicians in Uganda. An iterative design process was then used to advance an initial prototype into a fully-functional digital health intervention. The evaluation phase involved usability testing of the developed intervention amongst Ugandan patients with HF and their clinicians.ResultsMedly Uganda is a digital health intervention that is fully integrated within a government-operated mobile health platform. The system allows patients to report daily HF symptoms, receive tailored treatment advice, and connect with a clinician when showing signs of decompensation. Medly Uganda harnesses Unstructured Supplementary Service Data technology that is already widely used in Uganda for mobile phone-based financial transactions. Usability testing showed the system to be accepted by patients, caregivers, and clinicians.ConclusionsMedly Uganda is a fully-functional and well-accepted digital health intervention that enables Ugandan HF patients to better care for themselves. Moving forward, we expect the system to help decongest cardiac clinics and improve self-care efficacy amongst HF patients in Uganda.

DailyDose is a decision support system developed at Oregon Health & Science University designed for people with T1D on MDI to improve glycemic control. It connects with Dexcom G6 and Medtronic's InPen. DailyDose runs on a smartphone and calculates insulin doses using CGM value and trend, IOB, carbohydrate amount, and exercise information. The system analyzes CGM and insulin data and automatically provides weekly recommendations on insulin settings, such as basal insulin dose and carbohydrate ratios, based on a k-nearest neighbors algorithm. Twenty-four adults with T1D used DailyDose for 8 weeks. The primary outcome was change in % time in range (TIR, 70-180 mg/dL) on CGM comparing the two week run-in period before starting DailyDose vs. final two weeks of DailyDose use. A mixed effects model was used to determine the impact of the % of accepted recommendations on change in % TIR. Users who accepted and followed recommendations showed a mean week-to-week improvement in TIR of 2.0% (Figure) . The mixed effects model shows week-by-week TIR increased by 7.8% when recommendations were accepted compared with not accepted (CI, 3-12%, P=.001) . Overall, there were no significant differences between TIR or time in hypoglycemia comparing the run-in period and the final two weeks of use. Further work is needed to encourage people using decision support systems to follow recommendations. Disclosure J.R.Castle: Advisory Panel; Insulet Corporation, Novo Nordisk, Zealand Pharma A/S, Stock/Shareholder; Pacific Diabetes Technologies. V.Gabo: None. J.H.Eom: None. J.El youssef: None. K.Ramsey: None. T.Kushner: Consultant; Tandem Diabetes Care, Inc. K.Winters-stone: None. J.A.Cafazzo: None. P.G.Jacobs: Other Relationship; Pacific Diabetes Technologies, Research Support; Dexcom, Inc. A.Z.Espinoza: None. N.S.Tyler: None. L.M.Wilson: n/a. C.M.Mosquera-lopez: None. J.Pinsonault: None. R.Dodier: None. S.M.Oganessian: None. D.Branigan: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust (Grant 2018PG-T1D001) .

Background and objectives Patients with CKD are at risk for adverse drug reactions, but effective community-based preventive programs remain elusive. In this study, we compared the effectiveness of two digital applications designed to improve outpatient medication safety. Design, setting, participants, & measurements In a 1-year randomized controlled trial, 182 outpatients with advanced CKD were randomly assigned to receive a smartphone preloaded with either eKidneyCare (n=89) or MyMedRec (n=93). The experimental intervention, eKidneyCare, includes a medication feature that prompted patients to review medications monthly and report changes, additions, or medication problems to clinicians for reconciliation and early intervention. The active comparator was MyMedRec, a commercially available, standalone application for storing medication and other health information that can be shared with patients' providers. The primary outcome was the rate of medication discrepancy, defined as differences between the patient's reported history and the clinic's medication record, at exit. Results At exit, the eKidneyCare group had fewer total medication discrepancies compared with MyMedRec (median, 0.45; interquartile range, 0.33-0.63 versus 0.67; interquartile range, 0.40-1.00; P=0.001), and the change from baseline was 0.13±0.27 in eKidneyCare and 0.30±0.41 in MyMedRec (P=0.007). eKidneyCare use also reduced the severity of clinically relevant medication discrepancies in all categories, including those with the potential to cause serious harm (estimated rate ratio, 0.40; 95% confidence interval, 0.27 to 0.63). Usage data revealed that 72% of patients randomized to eKidneyCare completed one or more medication reviews per month, whereas only 30% of patients in the MyMedRec group (adjusted for dropouts) kept their medication profile on their phone. Conclusions In patients who are high risk and have CKD, eKidneyCare significantly reduced the rate and severity of medication discrepancies, the proximal cause of medication errors, compared with the active comparator. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: www.clinicaltrials.gov, NCT:02905474.

Background For individuals living with diabetes and its psychosocial comorbidities (eg, depression, anxiety, and distress), there remains limited access to interprofessional, integrated care that includes mental health support, education, and follow-up. Health technology, broadly defined as the application of organized knowledge or skill as software, devices, and systems to solve health problems and improve quality of life, is emerging as a means of addressing these gaps. There is thus a need to understand how such technologies are being used to support, educate, and help individuals living with co-occurring diabetes and mental health distress or disorder. Objective The purpose of this scoping review was to (1) describe the literature on technology-enabled integrated interventions for diabetes and mental health; (2) apply frameworks from the Mental Health Commission of Canada and World Health Organization to elucidate the components, type, processes, and users of technology-enabled integrated interventions for diabetes and mental health; and (3) map the level of integration of interventions for diabetes and mental health. Methods We searched 6 databases from inception to February 2022 for English-language, peer-reviewed studies of any design or type that used technology to actively support both diabetes and any mental health distress or disorder in succession or concurrently among people with diabetes (type 1 diabetes, type 2 diabetes, and gestational diabetes). Reviewers screened citations and extracted data including study characteristics and details about the technology and integration used. Results We included 24 studies described in 38 publications. These studies were conducted in a range of settings and sites of care including both web-based and in-person settings. Studies were mostly website-based (n=13) and used technology for wellness and prevention (n=16) and intervention and treatment (n=15). The primary users of these technologies were clients and health care providers. All the included intervention studies (n=20) used technology for clinical integration, but only 7 studies also used the technology for professional integration. Conclusions The findings of this scoping review suggest that there is a growing body of literature on integrated care for diabetes and mental health enabled by technology. However, gaps still exist with how to best equip health care professionals with the knowledge and skills to offer integrated care. Future research is needed to continue to explore the purpose, level, and breadth of technology-enabled integration to facilitate an approach to overcome or address care fragmentation for diabetes and mental health and to understand how health technology can further drive the scale-up of innovative integrated interventions.

IntroductionTransition from paediatric to adult care can be challenging for youth living with type 1 diabetes (T1D), as many youth feel unprepared to transfer to adult care and are at high risk for deterioration of glycaemic management and acute complications. Existing strategies to improve transition experience and outcomes are limited by cost, scalability, generalisability and youth engagement. Text messaging is an acceptable, accessible and cost-effective way of engaging youth. Together with adolescents and emerging adults and paediatric and adult T1D providers, we co-designed a text message-based intervention, Keeping in Touch (KiT), to deliver tailored transition support. Our primary objective is to test the effectiveness of KiT on diabetes self-efficacy in a randomised controlled trial.Methods and analysisWe will randomise 183 adolescents with T1D aged 17–18 years within 4 months of their final paediatric diabetes visit to the intervention or usual care. KiT will deliver tailored T1D transition support via text messages over 12 months based on a transition readiness assessment. The primary outcome, self-efficacy for diabetes self-management, will be measured 12 months after enrolment. Secondary outcomes, measured at 6 and 12 months, include transition readiness, perceived T1D-related stigma, time between final paediatric and first adult diabetes visits, haemoglobin A1c, and other glycaemia measures (for continuous glucose monitor users), diabetes-related hospitalisations and emergency department visits and the cost of implementing the intervention. The analysis will be intention-to-treat comparing diabetes self-efficacy at 12 months between groups. A process evaluation will be conducted to identify elements of the intervention and individual-level factors influencing implementation and outcomes.Ethics and disseminationThe study protocol version 7 July 2022 and accompanying documents were approved by Clinical Trials Ontario (Project ID: 3986) and the McGill University Health Centre (MP-37-2023-8823). Study findings will be presented at scientific conferences and in peer-reviewed publications.Trial registration numberNCT05434754.

There is a growing interest to investigate the feasibility of using voice user interfaces as a platform for digital therapeutics in chronic disease management. While mostly deployed as smartphone applications, some demographics struggle when using touch screens and often cannot complete tasks independently. This research aimed to evaluate how heart failure patients interacted with a voice app version of an already existing digital therapeutic, Medly, using a mixed-methods concurrent triangulation approach. The objective was to determine the acceptability and feasibility of the voice app by better understanding who this platform is be best suited for. Quantitative data included engagement levels and accuracy rates. Participants (n=20) used the voice app over a four week period and completed questionnaires and semi-structured interviews relating to acceptability, ease of use, and workload. The average engagement level was 73%, with a 14% decline between week one and four. The difference in engagement levels between the oldest and youngest demographic was the most significant, 84% and 43% respectively. The Medly voice app had an overall accuracy rate of 97.8% and was successful in sending data to the clinic. Users were accepting of the technology (ranking it in the 80th percentile) and felt it did not require a lot of work (2.1 on a 7-point Likert scale). However, 13% of users were less inclined to use the voice app at the end of the study. The following themes and subthemes emerged: (1) feasibility of clinical integration: user adaptation to voice app’s conversational style, device unreliability, and (2) voice app acceptability: good device integration within household, users blamed themselves for voice app problems, and voice app missing desirable user features. The voice app proved to be most beneficial to those who: are older, have flexible schedules, are confident with using technology, and are experiencing other medical conditions.

The use of digital therapeutics (DTx) in the prevention and management of medical conditions has increased through the years with an estimated 44 million people using one as part of their treatment plan in 2021, nearly double the amount from last year. DTx are commonly accessed through smartphone apps, but offering these treatments through an alternative input can improve the accessibility of these interventions. Voice apps are an emerging technology in the digital health field, and may be an appropriate alternative platform for some patients. This research aimed to identify the acceptability and feasibility of offering a voice app as an alternative input for a chronic disease self-management program. The objective of this project was to design, develop, and evaluate a voice app of an already existing smartphone-based heart failure self-management program, Medly, to be used as a case study. A voice app version of Medly was designed and developed through a user-centered design process. We conducted a usability study and semi-structured interviews with representative end users (n=8) at the Peter Munk Cardiac Clinic in Toronto General Hospital to better understand the user experience. A Medly voice app prototype was built using a software development kit in tandem with a cloud computing platform. Three out of the eight participants were successful in completing the usability session, while the rest of the participants were not due to various errors. Almost all (7 out of the 8) participants were satisfied with the voice app and felt confident using it. Half of the participants were unsure about using the voice app in the future, though. With these findings, design changes were made to better improve the user experience. With rapid advancements in voice user interfaces, we believe this technology will play an integral role when providing access to DTx for chronic disease management.

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 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. CLINICALTRIAL ClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8367

BackgroundDespite 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.ObjectiveThis 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.MethodsA 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 (PResultsA 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.ConclusionsWe 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 RegistrationClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852International Registered Report Identifier (IRRID)RR2-10.2196/resprot.8367

Introduction Digital health tools may be effective in engaging solid organ transplant (SOT) recipients in physical activity (PA). This study examined the perspectives of SOT recipients regarding PA, and desired features for digital health tools. Methods Semi-structured interviews were used to explore perspectives of SOT recipients about barriers and motivators to physical activity, and core features of a digital health tool to support PA. Interviews were analyzed via thematic analysis. Results Participants included 21 SOT recipients (11 men, 10 women, 21-78 years, 1.5-16 years post-transplant) from various organ groups (4 heart, 5 kidney, 5 liver, 3 lung, and 4 multi-organ). Barriers to PA included risk aversion, managing non-linear health trajectories, physical limitations and lack of access to appropriate fitness training. Facilitators of PA included desire to live long and healthy lives, renewed physical capabilities, access to appropriate fitness guidelines and facilities. Desired features of a digital health tool included a reward system, affordability, integration of multiple functions, and the ability to selectively share information with healthcare professionals and peers. Conclusions SOT recipients identified the desired features of a digital health tool, which may be incorporated into future designs of digital and mobile health applications to support PA in SOT recipients. This article is protected by copyright. All rights reserved.

IntroductionProstate cancer (PCa) is the most common cancer in Canadian men. Current models of survivorship care are no longer adequate to address the chronic and complex survivorship needs of patients today. Virtual care models for cancer survivorship have recently been associated with comparable clinical outcomes and lower costs to traditional follow-up care, with patients favouring off-site and on-demand visits. Building on their viability, our research group conceived the Ned Clinic—a virtual PCa survivorship model that provides patients with access to lab results, collects patient-reported outcomes, alerts clinicians to emerging issues, and promotes patient self-care. Despite the promise of the Ned Clinic, the model remains limited by its dependence on oncology specialists, lack of an autonomous triage algorithm, and has only been implemented among PCa survivors living in Ontario.Methods and analysisOur programme of research comprises two main research objectives: (1) to evaluate the process and cost of implementing and sustaining five nurse-led virtual PCa survivorship clinics in three provinces across Canada and identify barriers and facilitators to implementation success and (2) to assess the impact of these virtual clinics on implementation and effectiveness outcomes of enrolled PCa survivors. The design phase will involve developing an autonomous triage algorithm and redesigning the Ned Clinic towards a nurse-led service model. Site-specific implementation plans will be developed to deploy a localised nurse-led virtual clinic at each centre. Effectiveness will be evaluated using a historical control study comparing the survivorship outcomes of 300 PCa survivors enrolled in the Ned Clinic with 300 PCa survivors receiving traditional follow-up care.Ethics and disseminationAppropriate site-specific ethics approval will be secured prior to each research phase. Knowledge translation efforts will include diffusion, dissemination, and application approaches to ensure that knowledge is translated to both academic and lay audiences.

BACKGROUND Recent shifts to telemedicine and remote patient monitoring demonstrate the potential for new technology to transform health systems; yet, methods to design for inclusion and resilience are lacking. OBJECTIVE The aim of this study is to design and implement a participatory framework to produce effective health care solutions through co-design with diverse stakeholders. METHODS We developed a design framework to cocreate solutions to locally prioritized health and communication problems focused on cancer care. The framework is premised on the framing and discovery of problems through community engagement and lead-user innovation with the hypothesis that diversity and inclusion in the co-design process generate more innovative and resilient solutions. Discovery, design, and development were implemented through structured phases with design studios at various locations in urban and rural Kentucky, including Appalachia, each building from prior work. In the final design studio, working prototypes were developed and tested. Outputs were assessed using the System Usability Scale as well as semistructured user feedback. RESULTS We co-designed, developed, and tested a mobile app (myPath) and service model for distress surveillance and cancer care coordination following the LAUNCH (Linking and Amplifying User-Centered Networks through Connected Health) framework. The problem of awareness, navigation, and communication through cancer care was selected by the community after framing areas for opportunity based on significant geographic disparities in cancer and health burden resource and broadband access. The codeveloped digital myPath app showed the highest perceived combined usability (mean 81.9, SD 15.2) compared with the current gold standard of distress management for patients with cancer, the paper-based National Comprehensive Cancer Network Distress Thermometer (mean 74.2, SD 15.8). Testing of the System Usability Scale subscales showed that the myPath app had significantly better usability than the paper Distress Thermometer (t63=2.611; P=.01), whereas learnability did not differ between the instruments (t63=–0.311; P=.76). Notable differences by patient and provider scoring and feedback were found. CONCLUSIONS Participatory problem definition and community-based co-design, design-with methods, may produce more acceptable and effective solutions than traditional design-for approaches.

Key Points Question Can virtual care (VC) be rapidly implemented across a tertiary center during the coronavirus disease 2019 (COVID-19) pandemic, and what are service capacity and quality outcomes? Findings This cohort study of 22 085 VC visits at a single cancer center suggests feasibility of an agile service design process for implementation of VC at scale. This approach preserved outpatient caseloads and maintained care quality in all 6 care-quality domains of care quality laid out by the Institute of Medicine while rendering high patient and practitioner satisfaction. Meaning These data support the value proposition of VC to safeguard system capacity, while minimizing the disruption to patient care during a pandemic., Importance The coronavirus disease 2019 (COVID-19) pandemic has burdened health care resources and disrupted care of patients with cancer. Virtual care (VC) represents a potential solution. However, few quantitative data support its rapid implementation and positive associations with service capacity and quality. Objective To examine the outcomes of a cancer center–wide virtual care program in response to the COVID-19 pandemic. Design, Setting, and Participants This cohort study applied a hospitalwide agile service design to map gaps and develop a customized digital solution to enable at-scale VC across a publicly funded comprehensive cancer center. Data were collected from a high-volume cancer center in Ontario, Canada, from March 23 to May 22, 2020. Main Outcomes and Measures Outcome measures were care delivery volumes, quality of care, patient and practitioner experiences, and cost savings to patients. Results The VC solution was developed and launched 12 days after the declaration of the COVID-19 pandemic. A total of 22 085 VC visits (mean, 514 visits per day) were conducted, comprising 68.4% (range, 18.8%-100%) of daily visits compared with 0.8% before launch (P, This cohort study of a publicly funded comprehensive cancer center examines the outcomes of a cancer center–wide virtual care program in response to the COVID-19 pandemic.

Background Indigenous populations have remained strong and resilient in maintaining their unique culture and values, despite centuries of colonial oppression. Unfortunately, a consequential result of facing years of adversity has led Indigenous populations to experience a disproportionate level of poorer health outcomes compared to non-Indigenous populations. Specifically, the rate of Indigenous chronic disease prevalence has significantly increased in the last decade. Many of the unique issues Indigenous populations experience are deeply rooted in their colonial history and the intergenerational traumas that has subsequently impacted their physical, mental, emotional and spiritual well-being. With this, to better improve Indigenous health outcomes, understanding the local context of their challenges is key. Studies have begun to use modes of community engagement to initiate Indigenous partnerships and design chronic disease-based interventions. However, with the lack of a methodological guideline regarding the appropriate level of community engagement to be used, there is concern that many interventions will continue to fall short in meeting community needs. Objective The objective of this study was to investigate the how various community engagement strategies have been used to design and/or implement interventions for Indigenous populations with chronic disease. Methods A scoping review guided by the methods outlined by Arksey and O’Malley was conducted. A comprehensive search was completed by two reviewers in five electronic databases using keywords related to community engagement, Indigenous health and chronic disease. Studies were reviewed using a descriptive-analytical narrative method and data was categorized into thematic groups reflective of the main findings. Results We identified 23 articles that met the criteria for this scoping review. The majority of the studies included the use a participatory research model and the procurement of study approval. However, despite the claimed use of participatory research methods, only 6 studies had involved community members to identify the area of priority and only five had utilized Indigenous interview styles to promote meaningful feedback. Adapting for the local cultural context and the inclusion of community outreach were identified as the key themes from this review. Conclusion Many studies have begun to adopt community engagement strategies to better meet the needs of Indigenous Peoples. With the lack of a clear guideline to approach Indigenous-based participatory research, we recommend that researchers focus on 1) building partnerships, 2) obtaining study approval and 3) adapting interventions to the local context.

BACKGROUND The emergence of genetic and genomic sequencing approaches for pediatric patients has raised questions about the genomic health literacy levels, attitudes toward receiving genomic information, and use of this information to inform treatment decisions by pediatric patients and their parents. However, the methods to educate pediatric patients and their parents about genomic concepts through digital health interventions have not been well-established. OBJECTIVE The primary objective of this scoping review is to investigate the current levels of genomic health literacy and the attitudes toward receiving genomic information among pediatric patients and their parents. The secondary aim is to investigate patient education interventions that aim to measure and increase genomic health literacy among pediatric patients and their parents. The findings from this review will be used to inform future digital health interventions for patient education. METHODS A scoping review using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines and protocols was completed using the following databases: MEDLINE, Embase, CINAHL, and Scopus. Our search strategy included genomic information inclusive of all genetic and genomic terms, pediatrics, and patient education. Inclusion criteria included the following: the study included genetic, genomic, or a combination of genetic and genomic information; the study population was pediatric (children and adolescents RESULTS Of the 4618 studies, 14 studies (n=6, 43% qualitative, n=6, 43% mixed methods, and n=2, 14% quantitative) were included. Key findings were based on the following 6 themes: knowledge of genomic concepts, use of the internet and social media for genomic information, use of genomic information for decision-making, hopes and attitudes toward receiving genomic information, experiences with genetic counseling, and interventions to improve genomic knowledge. CONCLUSIONS This review identified that older age is related to the capacity of understanding genomic concepts, increased genomic health literacy levels, and the perceived ability to participate in decision-making related to genomic information. In addition, internet-searching plays a major role in obtaining genomic information and filling gaps in communication with health care providers. However, little is known about the capacity of pediatric patients and their parents to understand genomic information and make informed decisions based on the genomic information obtained. More research is required to inform digital health interventions and to leverage the leading best practices to educate these genomic concepts.

Background Recent shifts to telemedicine and remote patient monitoring demonstrate the potential for new technology to transform health systems; yet, methods to design for inclusion and resilience are lacking. Objective The aim of this study is to design and implement a participatory framework to produce effective health care solutions through co-design with diverse stakeholders. Methods We developed a design framework to cocreate solutions to locally prioritized health and communication problems focused on cancer care. The framework is premised on the framing and discovery of problems through community engagement and lead-user innovation with the hypothesis that diversity and inclusion in the co-design process generate more innovative and resilient solutions. Discovery, design, and development were implemented through structured phases with design studios at various locations in urban and rural Kentucky, including Appalachia, each building from prior work. In the final design studio, working prototypes were developed and tested. Outputs were assessed using the System Usability Scale as well as semistructured user feedback. Results We co-designed, developed, and tested a mobile app (myPath) and service model for distress surveillance and cancer care coordination following the LAUNCH (Linking and Amplifying User-Centered Networks through Connected Health) framework. The problem of awareness, navigation, and communication through cancer care was selected by the community after framing areas for opportunity based on significant geographic disparities in cancer and health burden resource and broadband access. The codeveloped digital myPath app showed the highest perceived combined usability (mean 81.9, SD 15.2) compared with the current gold standard of distress management for patients with cancer, the paper-based National Comprehensive Cancer Network Distress Thermometer (mean 74.2, SD 15.8). Testing of the System Usability Scale subscales showed that the myPath app had significantly better usability than the paper Distress Thermometer (t63=2.611; P=.01), whereas learnability did not differ between the instruments (t63=–0.311; P=.76). Notable differences by patient and provider scoring and feedback were found. Conclusions Participatory problem definition and community-based co-design, design-with methods, may produce more acceptable and effective solutions than traditional design-for approaches.

UNSTRUCTURED There is clear evidence to suggest that diabetes does not affect all populations equally. Among adults living with diabetes, those from ethnoracial minority communities—foreign-born, immigrant, refugee, and culturally marginalized—are at increased risk of poor health outcomes. Artificial intelligence (AI) is actively being researched as a means of improving diabetes management and care; however, several factors may predispose AI to ethnoracial bias. To better understand whether diabetes AI interventions are being designed in an ethnoracially equitable manner, we conducted a secondary analysis of 141 articles included in a 2018 review by Contreras and Vehi entitled “Artificial Intelligence for Diabetes Management and Decision Support: Literature Review.” Two members of our research team independently reviewed each article and selected those reporting ethnoracial data for further analysis. Only 10 articles (7.1%) were ultimately selected for secondary analysis in our case study. Of the 131 excluded articles, 118 (90.1%) failed to mention participants’ ethnic or racial backgrounds. The included articles reported ethnoracial data under various categories, including race (n=6), ethnicity (n=2), race/ethnicity (n=3), and percentage of Caucasian participants (n=1). Among articles specifically reporting race, the average distribution was 69.5% White, 17.1% Black, and 3.7% Asian. Only 2 articles reported inclusion of Native American participants. Given the clear ethnic and racial differences in diabetes biomarkers, prevalence, and outcomes, the inclusion of ethnoracial training data is likely to improve the accuracy of predictive models. Such considerations are imperative in AI-based tools, which are predisposed to negative biases due to their black-box nature and proneness to distributional shift. Based on our findings, we propose a short questionnaire to assess ethnoracial equity in research describing AI-based diabetes interventions. At this unprecedented time in history, AI can either mitigate or exacerbate disparities in health care. Future accounts of the infancy of diabetes AI must reflect our early and decisive action to confront ethnoracial inequities before they are coded into our systems and perpetuate the very biases we aim to eliminate. If we take deliberate and meaningful steps now toward training our algorithms to be ethnoracially inclusive, we can architect innovations in diabetes care that are bound by the diverse fabric of our society.

Introduction: As we progress to an era when patient autonomy and shared decision-making are highly valued, there is a need to also have effective patient-centered communication tools. Radiology reports are designed for clinicians and can be very technical and difficult for patients to understand. It is important for patients to understand their magnetic resonance imaging (MRI) report in order to make an informed treatment decision with their physician. Therefore, we aimed to create a patient-centered prostate MRI report in order to give our patients a better understanding of their clinical condition. Methods: A prototype patient-centered radiology report (PACERR) was created by identifying items to include based on opinions sought from a group of patients undergoing prostate MRI and medical experts. Data was collected in semi-structured interviews using a salient belief question. A prototype PACERR was created in collaboration with human factors engineering and design, medical imaging, biomedical informatics, and cancer patient education groups. Results: Fifteen patients and eight experts from urology, radiation oncology, radiology, and nursing participated in this study. Patients were particularly interested to have a report with laymen terms, concise language, contextualization of values, definitions of medical terms, and next course of action. Everyone believed the report should include the risk of MRI findings actually being cancer in the subsequent biopsy. Conclusions: A prostate MRI PACERR has been developed to communicate the most important findings relevant to decision-making in prostate cancer using patient-oriented design principles. The ability of this tool to improve patient knowledge and communication will be explored.

UNSTRUCTURED The coronavirus disease (COVID-19) is a global pandemic that significantly impacts people living with diabetes. Diabetes-related factors of glycemic control, medication pharmacodynamics, and insulin access can impact the severity of a COVID-19 infection. In this commentary, we explore how digital health can support the diabetes community through the pandemic. For those living with diabetes, digital health presents the opportunity to access care with greater convenience while not having to expose themselves to infection in an in-person clinic. Digital diabetes apps can increase agency in self-care and produce clinically significant improvement in glycemic control through facilitating the capture of diabetes device data. However, the ability to share these data back to the clinic to inform virtual care and enhance diabetes coaching and guidance remains a challenge. In the end, it requires an unnecessarily high level of technical sophistication on the clinic’s part and on those living with diabetes to routinely use their diabetes device data in clinic visits, virtual or otherwise. As the world comes together to fight the COVID-19 pandemic, close collaboration among the global diabetes community is critical to understand and manage the sustained impact of the pandemic on people living with diabetes.

BACKGROUND Digital technologies connect young people with health services and resources that support their self-care. The lack of accessible, reliable digital resources tailored to young people with persistent musculoskeletal pain is a significant gap in the health services in Australia. Recognizing the intense resourcing required to develop and implement effective electronic health (eHealth) interventions, the adaptation of extant, proven digital technologies may improve access to pain care with cost and time efficiencies. OBJECTIVE This study aimed to test the acceptability and need for adaptation of extant digital technologies, the painHEALTH website and the iCanCope with Pain app, for use by young Australians with musculoskeletal pain. METHODS A 3-phased, mixed methods evaluation was undertaken from May 2019 to August 2019 in Australia. Young people aged 15 to 25 years with musculoskeletal pain for >3 months were recruited. Phases were sequential: (1) phase 1, participant testing (3 groups, each of n=5) of co-designed website prototypes compared with a control website (painHEALTH), with user tasks mapped to eHealth quality and engagement criteria; (2) phase 2, participants’ week-long use of the iCanCope with Pain app with engagement data captured using a real-time analytic platform (daily check-ins for pain, interference, sleep, mood, physical activity, and energy levels; goal setting; and accessing resources); and (3) phase 3, semistructured interviews were conducted to gain insights into participants’ experiences of using these digital technologies. RESULTS Fifteen young people (12/15, 80% female; mean age 20.5 [SD 3.3] years; range 15-25 years) participated in all 3 phases. The phase 1 aggregated group data informed the recommendations used to guide 3 rapid cycles of prototype iteration. Adaptations included optimizing navigation, improving usability (functionality), and enhancing content to promote user engagement and acceptability. In phase 2, all participants checked in, with the highest frequency of full check-ins attributed to pain intensity (183/183, 100.0%), pain interference (175/183, 95.6%), and mood (152/183, 83.1%), respectively. Individual variability was evident for monitoring progress with the highest frequency of history views for pain intensity (51/183, 32.3%), followed by pain interference (24/183, 15.2%). For the goals set feature, 87% (13/15) of participants set a total of 42 goals covering 5 areas, most frequently for activity (35/42, 83%). For phase 3, metasynthesis of qualitative data highlighted that these digital tools were perceived as youth-focused and acceptable. A total of 4 metathemes emerged: (1) importance of user-centered design to leverage user engagement; (2) website design (features) promoting user acceptability and engagement; (3) app functionality supporting self-management; and (4) the role of wider promotion, health professional digital prescriptions, and strategies to ensure longer-term engagement. CONCLUSIONS Leveraging extant digital tools, with appropriate user-informed adaptations, can help to build capacity tailored to support young people’s self-management of musculoskeletal pain.

Objectives To evaluate the feasibility and preliminary effectiveness of iCanCope with Pain (iCanCope), a smartphone-based pain self-management program, in adolescents with JIA. iCanCope featured symptom tracking, goal-setting, pain coping skills and social support. Methods A two-arm pilot randomized controlled trial was used to evaluate the iCanCope app compared with a version with symptom tracking only. Primary (feasibility) outcomes were: participant accrual/attrition rates, success of app deployment, acceptability and adherence. Secondary (preliminary effectiveness) outcomes were: pain intensity, pain-related activity limitations and health-related quality of life. Outcomes were assessed at baseline and 8 weeks. Adherence was defined as the proportion of completed symptom reports: ‘low’ (≤24%); ‘low-moderate’ (25–49%); ‘high-moderate’ (50–75%); or ‘high’ (76–100%). Linear mixed models were applied for preliminary effectiveness analyses as per intention-to-treat. Results Adolescents (N = 60) were recruited from three paediatric rheumatology centres. Rates of accrual and attrition were 82 and 13%, respectively. Both apps were deployed with high success (over 85%) and were rated as highly acceptable. Adherence was similar for both groups, with most participants demonstrating moderate-to-high adherence. Both groups exhibited a clinically meaningful reduction in pain intensity (≥1 point) that did not statistically differ between groups. There were no significant changes in activity limitations or health-related quality of life. Conclusion The iCanCope pilot randomized controlled trial was feasible to implement in a paediatric rheumatology setting. Both apps were deployed successfully, with high acceptability, and were associated with moderate-to-high adherence. Preliminary reductions in pain intensity warrant a future trial to evaluate effectiveness of iCanCope in improving health outcomes in adolescents with JIA. Trial registration ClinicalTrials.gov identifier: NCT02764346.

Increasingly, blame is being directed at health information technologies for how poorly they have been integrated into practice and how they are contributing to a poor experience for clinicians and patients alike. Although usability issues are often cited as a major aspect of why there is poor uptake and utility of health information technology, it is being recognized that the design problems extend well beyond the product user interface. To address this challenge, we will cover actual case studies on how the design of digital health interventions needs to be taken out of the designer’s comfort zone—well outside of the focus group, workshop, and studio setting and into the clinic and people’s homes—through contemporary service design techniques.

Objectives We sought to examine the prevalence of prospective registration and publication rates in digital health trials. Materials and Methods We included 417 trials that enrolled participants in 2012 and were registered in any of the 17 WHO data provider registries. The evaluation of the prospective trial registration was based on the actual difference between the registration and enrollment dates. We identified existing publications through an automated PubMed search by every trial registration number as well as a pragmatic search in PubMed and Google based on extracted metadata from the trial registries. Results The prospective registration and publication rates were at (38.4%) and (65.5%), respectively. We identified a statistically significant ( p Conclusion The adherence of investigators to the best practices of trial registration and result dissemination is still evolving in digital health trials. Further research is required to identify contributing factors and mitigation strategies to low compliance rate with trial publication and prospective registration in digital health trials.

Background The emergence of genetic and genomic sequencing approaches for pediatric patients has raised questions about the genomic health literacy levels, attitudes toward receiving genomic information, and use of this information to inform treatment decisions by pediatric patients and their parents. However, the methods to educate pediatric patients and their parents about genomic concepts through digital health interventions have not been well-established. Objective The primary objective of this scoping review is to investigate the current levels of genomic health literacy and the attitudes toward receiving genomic information among pediatric patients and their parents. The secondary aim is to investigate patient education interventions that aim to measure and increase genomic health literacy among pediatric patients and their parents. The findings from this review will be used to inform future digital health interventions for patient education. Methods A scoping review using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines and protocols was completed using the following databases: MEDLINE, Embase, CINAHL, and Scopus. Our search strategy included genomic information inclusive of all genetic and genomic terms, pediatrics, and patient education. Inclusion criteria included the following: the study included genetic, genomic, or a combination of genetic and genomic information; the study population was pediatric (children and adolescents Results Of the 4618 studies, 14 studies (n=6, 43% qualitative, n=6, 43% mixed methods, and n=2, 14% quantitative) were included. Key findings were based on the following 6 themes: knowledge of genomic concepts, use of the internet and social media for genomic information, use of genomic information for decision-making, hopes and attitudes toward receiving genomic information, experiences with genetic counseling, and interventions to improve genomic knowledge. Conclusions This review identified that older age is related to the capacity of understanding genomic concepts, increased genomic health literacy levels, and the perceived ability to participate in decision-making related to genomic information. In addition, internet-searching plays a major role in obtaining genomic information and filling gaps in communication with health care providers. However, little is known about the capacity of pediatric patients and their parents to understand genomic information and make informed decisions based on the genomic information obtained. More research is required to inform digital health interventions and to leverage the leading best practices to educate these genomic concepts.

Objective To honor the legacy of John Senders, a distinguished member of the Human Factors and Ergonomics Society, by a short, personal history of him, but then to honor his legacy by extending it through our own professional opinions, with an emphasis on the study of human error and its implications for healthcare systems—two topics in which he excelled. Background The authors are familiar with the topic and subject matter. One was a friend of Senders for over 50 years. Another was a collaborator and joint author with Senders (as well as his stepdaughter). All three authors have extensive publications in the topic areas. Method, Results, and Conclusion The authors used personal accounts of interactions with Senders at conferences, experiences living and working with him, and a brief review of his most personal, notable publications in healthcare. The reflections indicate a strong resonance on Senders’ contributions to system design that are relevant today in healthcare’s most challenging period in its history.

Purpose: A user-centered design approach was used to refine the mHealth Pain Squad+ real-time pain self-management app for adolescents with cancer for its usability (defined as being easy to use, easy to understand, efficient to complete, and acceptable). Method: Three iterative usability testing cycles involving adolescent observation and interview were used to achieve this objective. During each cycle, adolescents used the app while “thinking aloud” about issues encountered. Observed difficulties and errors were recorded and a semistructured interview about the experience was conducted. Using a qualitative conventional content analysis approach, themes related to app usability were identified. Results: Participants required an average of 4.3 minutes to complete the pain assessment component of Pain Squad+. Overall, the app was acceptable. Problematic issues related to software malfunction, interface design flaws, and confusing text. Software revisions were made to address each issue. Conclusion: The multifaceted usability approach used provided insight into how a real-time app can be made acceptable to adolescents with cancer and succeeded in developing a Pain Squad+ app that is fit for future effectiveness testing.

If we were to create the diabetes care experience anew, there is little doubt that it would not resemble the current bricks-and-mortar way we do things currently. For however a future model of care is designed, it would assume a digital-first approach, whereby the modern conveniences of digitally-mediated services we have experienced in other industries would be reflected in our diabetes care. To this end, our diabetes data would be liberated, transparent to those that need it, but safe and secure otherwise. We would have access to new tools that create insights that lower the burden, not add to it. And access to care would be just in time, convenient, and from a distance when needed. What is stopping a digital-first model is complex and deeply seated, but not insurmountable with engagement from industry, regulators, and care providers that are all willing to modernize the way care is delivered. Personal human interaction will continue to play an important part in the care for millions of people living with diabetes, no matter the sophistication of these digital services. What these technologies will provide is the human capacity to deal with the higher need, vulnerable people for whom access to timely care is an issue. Moreover, it will provide choice for an increasingly diverse population that seeks options for the form, and the delivery, of their personalized care.

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.

BACKGROUND Telemonitoring (TM) can improve heart failure (HF) outcomes by facilitating patient self-care and clinical decision support. However, these outcomes are only possible if patients consistently adhere to taking prescribed home readings. OBJECTIVE The objectives of this study were to (1) quantify the degree to which patients adhered to taking prescribed home readings in the context of a mobile phone–based TM program and (2) explain longitudinal adherence rates based on the duration of program enrollment, patient characteristics, and patient perceptions of the TM program. METHODS A mixed-methods explanatory sequential design was used to meet the 2 research objectives, and all explanatory methods were guided by the unified theory of acceptance and use of technology 2 (UTAUT2). Overall adherence rates were calculated as the proportion of days patients took weight, blood pressure, heart rate, and symptom readings over the total number of days they were enrolled in the program up to 1 year. Monthly adherence rates were also calculated as the proportion of days patients took the same 4 readings over each 30-day period following program enrollment. Next, simple and multivariate regressions were performed to determine the influence of time, age, sex, and disease severity on adherence rates. Additional explanatory methods included questionnaires at 6 and 12 months probing patients on the perceived benefits and ease of use of the TM program, an analysis of reasons for patients leaving the program, and semistructured interviews conducted with a purposeful sampling of patients (n=24) with a range of adherence rates and demographics. RESULTS Overall average adherence was 73.6% (SD 25.0) with average adherence rates declining over time at a rate of 1.4% per month (P CONCLUSIONS The decline in adherence rates over time is consistent with findings from other studies. However, this study also found adherence to be the highest and most consistent over time in older age groups and progressively lower over time for younger age groups. These findings can inform the design and implementation of TM interventions that maximize patient adherence, which will enable a more accurate evaluation of impact and optimization of resources.

Background and objectives Patient self-management has been shown to improve health outcomes. We developed a smartphone-based system to boost self-care by patients with CKD and integrated its use into usual CKD care. We determined its acceptability and examined changes in several clinical parameters. Design, setting, participants, & measurements We recruited patients with stage 4 or 5 CKD attending outpatient renal clinics who responded to a general information newsletter about this 6-month proof-of-principle study. The smartphone application targeted four behavioral elements: monitoring BP, medication management, symptom assessment, and tracking laboratory results. Prebuilt customizable algorithms provided real–time personalized patient feedback and alerts to providers when predefined treatment thresholds were crossed or critical changes occurred. Those who died or started RRT within the first 2 months were replaced. Only participants followed for 6 months after recruitment were included in assessing changes in clinical measures. Results In total, 47 patients (26 men; mean age =59 years old; 33% were ≥65 years old) were enrolled; 60% had never used a smartphone. User adherence was high (>80% performed ≥80% of recommended assessments) and sustained. The mean reductions in home BP readings between baseline and exit were statistically significant (systolic BP, −3.4 mmHg; 95% confidence interval, −5.0 to −1.8 and diastolic BP, −2.1 mmHg; 95% confidence interval, −2.9 to −1.2); 27% with normal clinic BP readings had newly identified masked hypertension. One hundred twenty-seven medication discrepancies were identified; 59% were medication errors that required an intervention to prevent harm. In exit interviews, patients indicated feeling more confident and in control of their condition; clinicians perceived patients to be better informed and more engaged. Conclusions Integrating a smartphone–based self–management system into usual care of patients with advanced CKD proved feasible and acceptable, and it appeared to be clinically useful. The results provide a strong rationale for a randomized, controlled trial.

Patients with diabetes often face serious complications due to limited self-management skills, the inability to adhere to care regimens, and psychosocial factors. Although regular self-monitoring of blood glucose is known to benefit patients receiving insulin therapy, its role in patients not treated with insulin has been unclear. However, recent studies have demonstrated that structured self-monitoring of blood glucose can significantly benefit patients who are not taking insulin, facilitating improved self-awareness and clinical decision making. We hypothesize that effective self-management by patients with type 2 diabetes who do not need insulin requires a behavioural intervention that enables the association between lifestyle behaviours, such as dietary intake and physical activity, and overall glycemic control. Mobile health applications (apps), coupled with wireless medical peripheral devices, can facilitate self-monitoring; deliver tailored, actionable knowledge; elicit positive behaviour changes and promote effective self-management of diabetes. Although existing apps incorporate tracking and feedback from healthcare providers, few attempt to elicit positive behaviour changes for the purposes of developing patients' self-care skills. The purpose of this article is to present a systematic approach to the design and development a diabetes self-management mobile app, which included 1) a scoping review of literature; 2) the development of an overarching theoretical approach and 3) validation of the app features through user-centred design methods. The resulting app, bant II, facilitates 1) self-monitoring of blood glucose, physical activity, diet and weight; 2) identification of glycemic patterns in relation to lifestyle; 3) remedial decision making and 4) positive behaviour change through incentives.

Objectives To evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration. Design Cross sectional analysis. Data sources PubMed, the 17 World Health Organization’s trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports. Study selection criteria RCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018. Results This study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P Conclusions This study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

Purpose Despite the benefits of physical activity (PA) after solid organ transplant (SOT), low PA levels persist. Electronic-health (e-health) tools may be effective in engaging SOT recipients in adopting/maintaining a physically active lifestyle. This study explores from the perspective of SOT recipients, barriers and motivators to exercise, and core features of an e-health tool that may address adoption and maintenance of PA. Methods A qualitative, descriptive study was conducted with SOT recipients, age >18, residing in Canada, who received a transplant at least 1 year ago. Semi structured interviews were conducted in English or French. Thematic analysis, via NVivo 12 was conducted. Results 21 participants (11 men, 10 women, aged: 47 ±15 years) completed interviews. Transplant type included heart = 4, lung =3, liver = 5, kidney = 5, multi-organ = 4. Emerging findings suggest that motivations to exercise are driven by increasing quality of life and longevity, honouring donors and second chances, new physical abilities and sensations, and SOT community engagement and support. Identified barriers to exercise are risk aversion, frequent appointments, health disruptions (i.e. illness and injury) and limited access to appropriate fitness facilities/advice/training. Lung recipients have concerns about oxygen saturation and immediate availability of supplemental oxygen, while heart recipients have concerns about over exertion. For both heart and lung groups, concerns about immunosuppression are a barrier. Desired features in an eHealth tool include comfortable, user friendly design, smart reward systems recognizing the PA trajectories of SOT recipients, possibility of sharing data with health care teams/other SOT recipients, capability of supporting multiple facets of SOT recipient specific health (water intake, medication reminders), and access to transplant specific fitness and diet guidance. A reliable heart rate monitor is stressed by heart transplant recipients, and for lung transplant recipients, oxygen saturation monitors. Conclusion Emergent findings suggest that SOT recipients have unique relationships with PA based on transplant type. These results suggest that an e-health tool with modifiable features depending on transplant type, may be of value.

Background: The New York Heart Association (NYHA) functional classification system has poor inter-rater reproducibility. A previously published pilot study showed a statistically significant difference between the daily step counts of heart failure (with reduced ejection fraction) patients classified as NYHA functional class II and III as measured by wrist-worn activity monitors. However, the study’s small sample size severely limits scientific confidence in the generalizability of this finding to a larger heart failure (HF) population. Objective: This study aimed to validate the pilot study on a larger sample of patients with HF with reduced ejection fraction (HFrEF) and attempt to characterize the step count distribution to gain insight into a more objective method of assessing NYHA functional class. Methods: We repeated the analysis performed during the pilot study on an independently recorded dataset comprising a total of 50 patients with HFrEF (35 NYHA II and 15 NYHA III) patients. Participants were monitored for step count with a Fitbit Flex for a period of 2 weeks in a free-living environment. Results: Comparing group medians, patients exhibiting NYHA class III symptoms had significantly lower recorded 2-week mean daily total step count (3541 vs 5729 [steps], P=.04), lower 2-week maximum daily total step count (10,792 vs 5904 [steps], P=.03), lower 2-week recorded mean daily mean step count (4.0 vs 2.5 [steps/minute], P=.04,), and lower 2-week mean and 2-week maximum daily per minute step count maximums (88.1 vs 96.1 and 111.0 vs 123.0 [steps/minute]; P=.02 and .004, respectively). Conclusions: Patients with NYHA II and III symptoms differed significantly by various aggregate measures of free-living step count including the (1) mean and (2) maximum daily total step count as well as by the (3) mean of daily mean step count and by the (4) mean and (5) maximum of the daily per minute step count maximum. These findings affirm that the degree of exercise intolerance of NYHA II and III patients as a group is quantifiable in a replicable manner. This is a novel and promising finding that suggests the existence of a possible, completely objective measure of assessing HF functional class, something which would be a great boon in the continuing quest to improve patient outcomes for this burdensome and costly disease.

Background: Moderate to severe postoperative pain in children is common. Increased pediatric day surgeries have shifted postoperative pain management predominantly to the home setting. Mobile health technology has the potential to overcome barriers to pain care by improving access to self-management resources. However, pain apps generally lack scientific evidence and are highly underutilized due to lack of involvement of end users in their development. Thus, an evidence-based pain self-management smartphone app that incorporates the needs and perspective of children and adolescents (end users) has potential to improve postoperative pain management. Objective: This paper aimed to describe how the principles of user-centered design were applied to the development of iCanCope PostOp, a smartphone-based pain self-management app for children and adolescents after surgery. Specifically, it presents 2 completed phases of the user-centered design process (concept generation and ideation) for the iCanCope PostOp app. Methods: Phase 1 was a multisite needs assessment from the perspective of 19 children and adolescents who had undergone various day surgeries, 19 parents, and 32 multidisciplinary health care providers. Children, adolescents, and parents completed individual semistructured interviews, and health care providers participated in focus groups. Data were summarized using qualitative content analysis. Phase 2 developed a pain care algorithm for the app using Delphi surveys and a 2-day in-person design workshop with 11 multidisciplinary pediatric postoperative pain experts and 2 people with lived experience with postoperative pain. Results: Phase 1 identified self-management challenges to postoperative pain management and recovery; limited available resources and reliance on medications as a predominant postoperative pain management strategy; and shared responsibility of postoperative pain care by children and adolescents, parents, and health care providers. Key app functions of tracking pain, pain self-management strategies, and goal setting were identified as priorities. Phase 2 led to the successful and efficient generation of a complete preliminary pain care algorithm for the iCanCope PostOp app, including clinically relevant inputs for feasible assessment and reassessment of pain and function (rest or sleep, movement or play, and mood or worry), as well as a catalog of pain management advice to be pushed to end users (psychological, physical, pharmacological, and education). Conclusions: The concept ideation and generation phases of the user-centered design approach were successfully completed for the iCanCope PostOp app. Next steps will include design finalization, app development (iOS or Android), evaluation through a randomized controlled trial, and subsequent implementation of the iCanCope PostOp app in clinical care.

Introduction: The globally increasing prevalence of chronic kidney disease has resulted in an ever-growing demand for renal replacement therapy. Although programs are present around the world, there is a paucity of immersive educational programs that train clinicians and administrators to develop new home dialysis programs. Explore Home Dialysis (EHD) is a program created to fill this gap. Methods: We present the results of the evaluation of the EHD program. Our team interviewed 23 clinicians and administrators who participated in the EHD program. We also assessed country-specific needs and challenges associated with home dialysis. Results: The 4 main findings include (i) the evaluation of the effectiveness of the EHD program; (ii) the need for an educational program to train individuals on how to deploy home dialysis programs; (iii) evidence that such an educational program is beneficial to participants and for the establishment of new home dialysis programs; and (iv) the identification of barriers to the development of home dialysis programs in countries represented in this study. The data show an increased demand, with strong patient and provider interest in establishing new programs, interest in accessing resources to train clinical and administrative staff in how to run a home dialysis program, and positive feedback about the EHD program in general. Conclusions: The data from this study were used in the next iteration of the EHD program, to inform clinicians about challenges in the deployment of new home dialysis programs, and to present educational resources that need to be developed in the future. Keywords: chronic kidney disease, clinicians, home dialysis, program evaluation

BACKGROUND Telemonitoring (TM) of heart failure (HF) patients in a clinic setting has been shown to be effective if properly implemented, but little is known about the feasibility and impact of implementing TM through a home care nursing agency. OBJECTIVE This study aimed to determine the feasibility of implementing a mobile phone–based TM system through a home care nursing agency and to explore the feasibility of conducting a future effectiveness trial. METHODS A feasibility study was conducted by recruiting, through community cardiologists and family physicians, 10 to 15 HF patients who would use the TM system for 4 months by taking daily measurements of weight and blood pressure and recording symptoms. Home care nurses responded to alerts generated by the TM system through either a phone call and/or a home visit. Patients and their clinicians were interviewed poststudy to determine their perceptions and experiences of using the TM system. RESULTS Only one community cardiologist was recruited who was willing to refer patients to this study, even after multiple attempts were made to recruit further physicians, including family physicians. The cardiologist referred only 6 patients over a 6-month period, and half of the patients dropped out of the study. The identified barriers to implementing the TM system in home care nursing were numerous and led to the small recruitment in patients and clinicians and large dropout rate. These barriers included challenges in nurses contacting patients and physicians, issues related to retention, and challenges related to integrating the TM system into a complex home care nursing workflow. However, some potential benefits of TM through a home care nursing agency were indicated, including improved patient education, providing nurses with a better understanding of the patient’s health status, and reductions in home visits. CONCLUSIONS Lessons learned included the need to incentivize physicians, to ensure streamlined processes for recruitment and communication, to target appropriate patient populations, and to create a core clinical group. Barriers encountered in this feasibility trial should be considered to determine their applicability when deploying innovations into different service delivery models.

BACKGROUND There is mixed evidence to support current ambitions for mobile health (mHealth) apps to improve chronic health and well-being. One proposed explanation for this variable effect is that users do not engage with apps as intended. The application of analytics, defined as the use of data to generate new insights, is an emerging approach to study and interpret engagement with mHealth interventions. OBJECTIVE This study aimed to consolidate how analytic indicators of engagement have previously been applied across clinical and technological contexts, to inform how they might be optimally applied in future evaluations. METHODS We conducted a scoping review to catalog the range of analytic indicators being used in evaluations of consumer mHealth apps for chronic conditions. We categorized studies according to app structure and application of engagement data and calculated descriptive data for each category. Chi-square and Fisher exact tests of independence were applied to calculate differences between coded variables. RESULTS A total of 41 studies met our inclusion criteria. The average mHealth evaluation included for review was a two-group pretest-posttest randomized controlled trial of a hybrid-structured app for mental health self-management, had 103 participants, lasted 5 months, did not provide access to health care provider services, measured 3 analytic indicators of engagement, segmented users based on engagement data, applied engagement data for descriptive analyses, and did not report on attrition. Across the reviewed studies, engagement was measured using the following 7 analytic indicators: the number of measures recorded (76%, 31/41), the frequency of interactions logged (73%, 30/41), the number of features accessed (49%, 20/41), the number of log-ins or sessions logged (46%, 19/41), the number of modules or lessons started or completed (29%, 12/41), time spent engaging with the app (27%, 11/41), and the number or content of pages accessed (17%, 7/41). Engagement with unstructured apps was mostly measured by the number of features accessed (8/10, P=.04), and engagement with hybrid apps was mostly measured by the number of measures recorded (21/24, P=.03). A total of 24 studies presented, described, or summarized the data generated from applying analytic indicators to measure engagement. The remaining 17 studies used or planned to use these data to infer a relationship between engagement patterns and intended outcomes. CONCLUSIONS Although researchers measured on average 3 indicators in a single study, the majority reported findings descriptively and did not further investigate how engagement with an app contributed to its impact on health and well-being. Researchers are gaining nuanced insights into engagement but are not yet characterizing effective engagement for improved outcomes. Raising the standard of mHealth app efficacy through measuring analytic indicators of engagement may enable greater confidence in the causal impact of apps on improved chronic health and well-being.

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.

BACKGROUND Mobile health (mHealth) apps for pediatric chronic conditions are growing in availability and challenge investigators to conduct rigorous evaluations that keep pace with mHealth innovation. Traditional research methods are poorly suited to operationalize the agile, iterative trials required to evidence and optimize these digitally mediated interventions. OBJECTIVE We sought to contribute a resource to support the quantification, analysis, and visualization of analytic indicators of effective engagement with mHealth apps for chronic conditions. METHODS We applied user-centered design methods to design and develop an Analytics Platform to Evaluate Effective Engagement (APEEE) with consumer mHealth apps for chronic conditions and implemented the platform to analyze both retrospective and prospective data generated from a smartphone-based pain self-management app called iCanCope for young people with chronic pain. RESULTS Through APEEE, we were able to automate the process of defining, operationalizing, and evaluating effective engagement with iCanCope. Configuring the platform to integrate with the app was feasible and provided investigators with a resource to consolidate, analyze, and visualize engagement data generated by participants in real time. Preliminary efforts to evaluate APEEE showed that investigators perceived the platform to be an acceptable evaluative resource and were satisfied with its design, functionality, and performance. Investigators saw potential in APEEE to accelerate and augment evidence generation and expressed enthusiasm for adopting the platform to support their evaluative practice once fully implemented. CONCLUSIONS Dynamic, real-time analytic platforms may provide investigators with a powerful means to characterize the breadth and depth of mHealth app engagement required to achieve intended health outcomes. Successful implementation of APEEE into evaluative practice may contribute to the realization of effective and evidence-based mHealth care.