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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.

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.

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.

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 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.

Background: Digital health could serve as a low-cost means of enabling better self-care in patients living with heart failure (HF) in resource-limited settings such as Uganda. However, digital health interventions previously deployed in such settings have been unsuccessful due to a lack of local patient and clinician engagement in the design process. Objective: To engage Ugandan HF patients and clinicians regarding their experiences with HF management and technology, so as to inform the future design of a digital health intervention for HF patients in Uganda. Methods: The study employed a convergent parallel mixed-methods design. Data collection was completed at the Uganda Heart Institute in Kampala, Uganda. Data were ascertained through a patient survey and semi-structured interviews completed with HF patients, caregivers, physicians, and nurses. A conventional content analysis approach was used to qualitatively examine interview transcripts. Findings: Survey data were collected from 101 HF patients (62 female/39 male, aged 54.2 ± 17.5 years). Nearly half (48%) disagreed that they knew what to do in response to changes in their HF symptoms. Almost all patients (98%) had access to a mobile device. Many patients (63%) identified as comfortable in using mobile money – a local set of services that use Unstructured Supplementary Service Data (USSD). Interviews were completed with 19 HF patients, three caregivers, seven physicians, and three nurses. Qualitative analysis revealed four clusters of themes: overdependence of patients on the clinic, inconvenience associated with attending the clinic, inconsistent patient self-care behaviours at home, and technological abilities that favoured USSD-based services. Conclusions: Ugandan HF patients possess unmet information needs that leave them ill-equipped to care for themselves. Future digital health interventions for this population should empower patients with HF-specific information and reassurance in their self-care abilities. Based on patient preferences, such systems should harness USSD technology with which most patients are already comfortable.

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.

IntroductionMore women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain.Methods and analysisThis protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3).Ethics and disseminationEthics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars.Trial registration numberNCT03800082.

Background Telemonitoring (TM) can improve heart failure (HF) outcomes by facilitating patient self-care and clinical decisions. The Medly program enables patients to use a mobile phone to record daily HF readings and receive personalized self-care messages generated by a clinically validated algorithm. The TM system also generates alerts, which are immediately acted upon by the patients’ existing care team. This program has been operating for 3 years as part of the standard of care in an outpatient heart function clinic in Toronto, Canada. Objective This study aimed to evaluate the 6-month impact of this TM program on health service utilization, clinical outcomes, quality of life (QoL), and patient self-care. Methods This pragmatic quality improvement study employed a pretest-posttest design to compare 6-month outcome measures with those at program enrollment. The primary outcome was the number of HF-related hospitalizations. Secondary outcomes included all-cause hospitalizations, emergency department visits (HF related and all cause), length of stay (HF related and all cause), and visits to the outpatient clinic. Clinical outcomes included bloodwork (B-type natriuretic peptide [BNP], creatinine, and sodium), left ventricular ejection fraction, and predicted survival score using the Seattle Heart Failure Model. QoL was measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the 5-level EuroQol 5-dimensional questionnaire. Self-care was measured using the Self-Care of Heart Failure Index (SCHFI). The difference in outcome scores was analyzed using negative binomial distribution and Poisson regressions for the health service utilization outcomes and linear regressions for all other outcomes to control for key demographic and clinical variables. Results Available data for 315 patients enrolled in the TM program between August 2016 and January 2019 were analyzed. A 50% decrease in HF-related hospitalizations (incidence rate ratio [IRR]=0.50; P Conclusions This study suggests that an HF TM program, which provides patients with self-care support and active monitoring by their existing care team, can reduce health service utilization and improve clinical, QoL, and patient self-care outcomes.

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.

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.

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.

BackgroundThere 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. ObjectiveThis 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. MethodsWe 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. ResultsA 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. ConclusionsAlthough 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 The prevalence of non-communicable diseases (NCDs) is rising in low- and middle-income countries (LMICs). Self-management, which enables patients to better manage their health, presents a potentially-scalable means of mitigating the growing burden of NCDs in LMICs. Though the effectiveness of self-management interventions in high-income countries is well-documented, the use of these strategies in LMICs has yet to be thoroughly summarized. Objective The purpose of this scoping review is to summarize the nature and effectiveness of past interventions that have enabled the self-management of NCDs in LMICs. Methods Using the scoping review methodology proposed by Arksey and O'Malley, PubMed was searched for relevant articles published between January 2007 and December 2018. The implemented search strategy comprised three major themes: self-management, NCDs and LMICs. Results Thirty-six original research articles were selected for inclusion. The selected studies largely focused on the self-management of diabetes (N = 21), hypertension (N = 7) and heart failure (N = 5). Most interventions involved the use of short message service (SMS, N = 17) or phone calls (N = 12), while others incorporated educational sessions (N = 10) or the deployment of medical devices (N = 4). The interventions were generally effective and often led to improvements in physiologic indicators, patient self-care and/or patient quality of life. However, the studies emphasized results in small populations, with little indication of future scaling of the intervention. Furthermore, the results indicate a need for further research into the self-management of cardiovascular diseases, as well as for the co-management of diabetes and cardiovascular disease. Conclusions Self-management appears to be an effective means of improving health outcomes in LMICs. Future strategies should include patients and clinicians in all stages of design and development, allowing for a focus on long-term sustainability, scalability and interoperability of the intervention in the target setting.

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.

People with multiple chronic conditions often struggle with managing their health. The purpose of this research was to identify specific challenges of patients with multiple chronic conditions and to use the findings to form design principles for a telemonitoring system tailored for these patients. Semi-structured interviews with 15 patients with multiple chronic conditions and 10 clinicians were conducted to gain an understanding of their needs and preferences for a smartphone-based telemonitoring system. The interviews were analyzed using a conventional content analysis technique, resulting in six themes. Design principles developed from the themes included that the system must be modular to accommodate various combinations of conditions, reinforce a routine, consolidate record keeping, as well as provide actionable feedback to the patients. Designing an application for multiple chronic conditions is complex due to variability in patient conditions, and therefore, design principles developed in this study can help with future innovations aimed to help manage this population.

Purpose/objectives To identify and appraise current evidence related to the effectiveness of psychological and physical (nonpharmacologic) pain management modalities for children and young adults with cancer . Data sources Electronic searches in MEDLINE, EMBASE, CINAHL, PsycINFO, and Web of Science (from database inception to June 2013) for clinical trials. Data synthesis A total of 32 unique studies were identified. Substantial heterogeneity existed across identified studies, precluding meta-analysis. Therefore, a narrative review of included studies is presented. Studies featured psychological and/or physical pain interventions for children and young adults (N = 1,171) aged 1-21 years with a variety of cancer diagnoses. Interventions included aromatherapy, art therapy, distraction, hypnosis, physical activity, physical positioning, touch therapy, and multimodal cognitive-behavior therapy. Twenty-two studies (69%) reported success in preventing or reducing pain intensity. The level of evidence and methodologic quality of studies were generally low . Conclusions Current nonpharmacologic pain interventions for pediatric and young adult patients with cancer are diverse. Several modalities significantly decreased pain intensity, suggesting that these strategies may be effective methods of pain treatment, particularly in the case of painful medical procedures. Future well-designed, multicenter, randomized, controlled trials are needed to further discern treatment effects on pain and other health outcomes in this population and to compare the relative effectiveness of different modalities. Implications for nursing Nurses play a key role in pain assessment and management in pediatric and young adult patients with cancer. The studies included in this review constitute the beginnings of an evidence base that supports the need to implement psychological and physical interventions to improve pain outcomes in pediatric and young adult patients with cancer.

Objective To gain insights into how technological communication tools impact effective communication among clinicians, which is critical for patient safety. Design This multi-site observational study analyzes inter-clinician communication and interaction with information technology, with a focus on the critical process of patient transfer from the Emergency Department to General Internal Medicine. Setting Mount Sinai Hospital, Sunnybrook Health Sciences Centre and Toronto General Hospital. Participants At least five ED and general internal medicine nurses and physicians directly involved in patient transfers were observed on separate occasions at each institution. Interventions N/A. Main Outcome Measures N/A. Results The study provides insight into clinician workflow, evaluates current hospital communication systems and identifies key issues affecting communication: interruptions, issues with numeric pagers, lack of integrated communication tools, lack of awareness of consultation status, inefficiencies related to the paper chart, unintuitive user interfaces, mixed use of electronic and paper systems and lack of up-to-date contact information. It also identifies design trade-offs to be negotiated: synchronous communication vs. reducing interruptions, notification of patient status vs. reducing interruptions and speed vs. quality of handovers. Conclusions The issues listed should be considered in the design of new technology for hospital communications.

As radiation therapy treatment grows more complex over time, treatment delivery has become more susceptible to adverse events and patient safety risks from use error. The radiation therapy monitoring and treatment delivery user interface explored in this study was redesigned using ecological interface design, a human factors engineering method, and evaluated to improve treatment safety.An initial design concept was created based on previously completed analysis and informally evaluated in focus groups with radiation therapists. Sixteen newly graduated radiation therapists used both the redesigned and current system in a usability test to determine if the redesigned system better supported detection of errors.The redesigned system successfully improved the error detection rate of 2 errors: wrong treatment volume and wrong treatment site (P.03 and P.01, respectively). It also improved level 2 and level 3 situation awareness (ie, comprehension of the meaning of the information and the projection of the behavior of the technology: P.01 and P.01, respectively) and achieved a higher user satisfaction.The ecological interface design approach was found to be effective in redesigning a radiation therapy treatment delivery interface. Radiation therapists were able to deliver simulated radiation therapy with a higher rate of error detection and improved higher-level situation awareness, and participants preferred the redesigned interface to the current interface. Overall, the redesigned interface improved the radiation therapists' system understanding and ability to detect errors that affect patient safety.

OBJECTIVE To explore the impact of environmental design on doffing personal protective equipment in a simulated healthcare environment. METHODS A mixed-methods approach was used that included human-factors usability testing and qualitative questionnaire responses. A patient room and connecting anteroom were constructed for testing purposes. This experimental doffing area was designed to overcome the environmental failures identified in a previous study and was not constructed based on any generalizable hospital standard. RESULTS In total, 72 healthcare workers from Ontario, Canada, took part in the study and tested the simulated doffing area. The following environmental design changes were tested and were deemed effective: increasing prominence of color-coded zones; securing disinfectant wipes and hand sanitizer; outlining disposal bins locations; providing mirrors to detect possible contamination; providing hand rails to assist with doffing; and restricting the space to doff. Further experimentation and iterative design are required with regard to several important features: positioning the disposal bins for safety, decreasing the risk of contamination and user accessibility; optimal positioning of mirrors for safety; communication within the team; and positioning the secondary team member for optimal awareness. Additional design suggestions also emerged during this study, and they require future investigation. CONCLUSIONS This study highlights the importance of the environment on doffing personal protective equipment in a healthcare setting. Iterative testing and modification of the design of the environment (doffing area) are important to enhancing healthcare worker safety. Infect Control Hosp Epidemiol 2017;38:712–717

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).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.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.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.

Effective chronic disease management is essential to improve positive health outcomes, and incentive strategies are useful in promoting self-care with longevity. Gamification, applied with mHealth (mobile health) applications, has the potential to better facilitate patient self-management. This review article addresses a knowledge gap around the effective use of gamification design principles, or mechanics, in developing mHealth applications. Badges, leaderboards, points and levels, challenges and quests, social engagement loops, and onboarding are mechanics that comprise gamification. These mechanics are defined and explained from a design and development perspective. Health and fitness applications with gamification mechanics include: bant which uses points, levels, and social engagement, mySugr which uses challenges and quests, RunKeeper which uses leaderboards as well as social engagement loops and onboarding, Fitocracy which uses badges, and Mango Health, which uses points and levels. Specific design considerations are explored, an example of the efficacy of a gamified mHealth implementation in facilitating improved self-management is provided, limitations to this work are discussed, a link between the principles of gaming and gamification in health and wellness technologies is provided, and suggestions for future work are made. We conclude that gamification could be leveraged in developing applications with the potential to better facilitate self-management in persons with chronic conditions.

Background Nurses are frequently interrupted during medication verification and administration; however, few interventions exist to mitigate resulting errors, and the impact of these interventions on medication safety is poorly understood. Objective The study objectives were to (A) assess the effects of interruptions on medication verification and administration errors, and (B) design and test the effectiveness of targeted interventions at reducing these errors. Methods The study focused on medication verification and administration in an ambulatory chemotherapy setting. A simulation laboratory experiment was conducted to determine interruption-related error rates during specific medication verification and administration tasks. Interventions to reduce these errors were developed through a participatory design process, and their error reduction effectiveness was assessed through a postintervention experiment. Results Significantly more nurses committed medication errors when interrupted than when uninterrupted. With use of interventions when interrupted, significantly fewer nurses made errors in verifying medication volumes contained in syringes (16/18; 89% preintervention error rate vs 11/19; 58% postintervention error rate; p=0.038; Fisher's exact test) and programmed in ambulatory pumps (17/18; 94% preintervention vs 11/19; 58% postintervention; p=0.012). The rate of error commission significantly decreased with use of interventions when interrupted during intravenous push (16/18; 89% preintervention vs 6/19; 32% postintervention; p=0.017) and pump programming (7/18; 39% preintervention vs 1/19; 5% postintervention; p=0.017). No statistically significant differences were observed for other medication verification tasks. Conclusions Interruptions can lead to medication verification and administration errors. Interventions were highly effective at reducing unanticipated errors of commission in medication administration tasks, but showed mixed effectiveness at reducing predictable errors of detection in medication verification tasks. These findings can be generalised and adapted to mitigate interruption-related errors in other settings where medication verification and administration are required.

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 Cardiovascular disease (CVD) has grown to become one of the leading causes of mortality worldwide. The advancements of CVD-related treatments have led to a decline in CVD prevalence among individuals in high-income countries (HICs). However, these improvements do not reflect the state of individuals in low- and middle-income countries (LMICs) and vulnerable subgroup populations in HICs, such as the Indigenous. To help minimize the health disparities in these populations, technology-based interventions have been offered as a potential solution, but there is concern regarding if they will be effective, or even needed, as these tools have been designed for use in HICs. Objective The objective of this study was to explore how mobile health (mHealth) interventions currently assist individuals in Indigenous communities and LMICs with CVD management. Methods A scoping review guided by the methods outlined by Arksey and O’Malley was conducted. A comprehensive search was completed by 2 reviewers in 5 electronic databases using keywords related to mobile health, cardiovascular disease, self-care, Indigenous communities, and LMICs. Studies were screened over 2 rounds and critically reviewed using a descriptive-analytical narrative method. Descriptive data were categorized into thematic groups reflecting the major findings related to the study objective. Results We identified a total of 11 original articles and 11 review papers that met the criteria for this scoping review. The majority of the studies included a telemonitoring- and text messaging (short message service, SMS)–related feature associated with the intervention. The use of SMS was the most common approach to effectively promote disease management among individuals in both LMICs and Indigenous communities. However, customizing for cultural considerations within the design of the intervention was highlighted as a pivotal component to encourage CVD management. Specifically, individuals emphasized that the inclusion of collaborative partnerships with community members would strengthen the effectiveness of the intervention by ensuring it was designed with the appropriate context. Conclusions Technology-based interventions used within Indigenous communities and LMICs have shown their potential to assist individuals with managing their condition. Although the literature available regarding this topic is limited, this review outlines key components to promote the effective use of these tools in the context of these vulnerable populations.

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. International Registered Report Identifier (IRRID) RR2-10.2196/resprot.9911

BackgroundUncontrolled asthma poses substantial negative personal and health system impacts. Web-based technologies, including smartphones, are novel means to enable evidence-based care and improve patient outcomes. ObjectiveThe aim of this study was to design, develop, and assess the utilization of an asthma collaborative self-management (CSM) platform (breathe) using content based on international evidence-based clinical guidelines. MethodsWe designed and developed breathe as a Web-based mobile health (mHealth) platform accessible on smartphones, tablets, or desktop with user-centered design methods and International Organization for Standardization–certified quality development processes. Moreover, breathe was envisioned as a multifunctional, CSM mHealth platform, with content based on international clinical practice guidelines and compliant with national privacy and security specifications. The system enabled CSM (patient, provider, and breathe) and self-monitoring of asthma patients through (1) assessment of asthma control, (2) real-time access to a dynamic asthma action plan, (3) access to real-time environmental conditions, and (4) risk-reduction messaging. The data collection protocol collected user data for 12 months, with clinic visits at baseline and 6 and 12 months. Utilization outcomes included user interactions with the platform, user impressions, self-reported medication use, asthma symptom profile, reported peak flow measurement, and the delivery and impact of email reminders. ResultsWe enrolled 138 patients with a mean age of 45.3 years to receive the breathe intervention. Majority were female (100/138, 72.5%), had a smartphone (92/138, 66.7%), and had a mean Asthma Control Test score of 18.3 (SD 4.9). A majority reported that breathe helped in the management of their asthma. Moreover, breathe scored 71.1 (SD 18.9) on the System Usability Scale. Overall, 123 patients had complete usage analytics datasets. The platform sent 7.96 reminder emails per patient per week (pppw), patients accessed breathe 3.08 times, journaled symptoms 2.56 times, reported medication usage 0.30 times, and reported peak flow measurements 0.92 times pppw. Furthermore, breathe calculated patients’ action plan zone of control 2.72 times pppw, with patients being in the green (well-controlled) zone in 47.71% (8300/17,396) of the total calculations. Usage analysis showed that 67.5% (83/123) of the participants used the app at week 4 and only 57.7% (71/123) by week 45. Physician visits, email reminders, and aged 50 years and above were associated with higher utilization. ConclusionsIndividuals with asthma reported good usability and high satisfaction levels, reacted to breathe notifications, and had confidence in the platform’s assessment of asthma control. Strong utilization was seen at the intervention’s initiation, followed by a rapid reduction in use. Patient reminders, physician visits, and being aged 50 years and above were associated with higher utilization. Trial RegistrationClinicalTrials.gov NCT01964469; https://clinicaltrials.gov/ct2/show/NCT01964469

BackgroundChronic pain is a common problem in adolescents that can negatively impact all aspects of their health-related quality of life. The developmental period of adolescence represents a critical window of opportunity to optimize and solidify positive health behaviors and minimize future pain-related disability and impaired work productivity. This research focuses on the development and evaluation of a smartphone-based pain self-management app for adolescents with chronic pain. ObjectiveThe objectives of this study were to characterize (1) the feasibility of deploying a mobile health (mHealth) app (iCanCope) to the personal smartphones of adolescent research participants; (2) adherence to daily symptom tracking over 55 consecutive days; (3) participant interaction with their symptom history; and (4) daily pain-related experiences of adolescents with chronic pain. MethodsWe recruited adolescents aged 15-18 years from 3 Canadian pediatric tertiary care chronic pain clinics. Participants received standardized instructions to download the iCanCope app and use it once a day for 55 days. Detailed app analytics were captured at the user level. Adherence was operationally defined as per the relative proportion of completed symptom reports. Linear mixed models were used to examine the trajectories of daily symptom reporting. ResultsWe recruited 60 participants between March 2017 and April 2018. The mean age of the participants was 16.4 (SD 0.9) years, and 88% (53/60) of them were female. The app was deployed to 98% (59/60) devices. Among the 59 participants, adherence was as follows: low (4, 7%), low-moderate (14, 24%), high-moderate (16, 27%), and high (25, 42%). Most (49/59, 83%) participants chose to view their historical symptom trends. Participants reported pain intensity and pain-related symptoms of moderate severity, and these ratings tended to be stable over time. ConclusionsThis study indicates that (1) the iCanCope app can be deployed to adolescents’ personal smartphones with high feasibility; (2) adolescents demonstrated moderate-to-high adherence over 55 days; (3) most participants chose to view their symptom history; and (4) adolescents with chronic pain experience stable symptomology of moderate severity. Trial RegistrationClinicalTrials.gov NCT02601755; https://clinicaltrials.gov/ct2/show/NCT02601755 (Archived by WebCite at http://www.webcitation.org/74F4SLnmc)

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.

To address the high incidence of infusion errors, manufacturers have replaced the development of standard infusion pumps with smart pump systems. The implementation and ongoing optimization processes for smart pumps are more complex, as they require larger coordinated efforts with stakeholders throughout the medication process. If improper implementation/optimization processes are followed, hospitals invest in this technology while extracting minimal benefit. We assessed the processes hospitals employed when migrating from standard to smart infusion systems, and the extent to which they leveraged their investments from both a systems and resource perspective. Twenty-nine hospitals in Ontario, Canada, were surveyed that had either implemented smart pump systems or were in the process of implementing, representing a response rate of 69%. Results demonstrated that hospitals purchased smart pumps for reasons other than safety, did not involve a multidisciplinary team during implementation, made little effort to standardize drug concentrations or develop drug libraries and dosing limits, seldom monitored how nurses use the pumps, and failed to ensure wireless connectivity to upgrade protocols and download use data. Consequently, they are failing to realize the safety benefits these systems can provide.

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

OBJECTIVETo identify issues during donning and doffing of personal protective equipment (PPE) for infectious diseases and to inform PPE procurement criteria and design.DESIGNA mixed methods approach was used. Usability testing assessed the appropriateness, potential for errors, and ease of use of various combinations of PPE. A qualitative constructivist approach was used to analyze participant feedback.SETTINGFour academic health sciences centers: 2 adult hospitals, 1 trauma center, and 1 pediatric hospital, in Toronto, Canada.PARTICIPANTSParticipants (n=82) were representative of the potential users of PPE within Western healthcare institutions.RESULTSNone of the tested combinations provided a complete solution for PPE. Environmental factors, such as anteroom layout, and the design of protocols and instructional material were also found to impact safety. The study identified the need to design PPE as a complete system, rather than mixing and matching components.CONCLUSIONSHealthcare institutions are encouraged to use human factors methods to identify risk and failure points with the usage of their selected PPE, and to modify on the basis of iterative evaluations with representative end users. Manufacturers of PPE should consider usability when designing the next generation of PPE.Infect Control Hosp Epidemiol2016;37:1022–1028

A common perception is that the use of Internet-based self-care systems is best suited for a younger, tech-proficient population, and that these systems will increase the burden on patients with complex chronic conditions. The study stratified patients with diabetes into three regimens of use of an Internet-based diabetes self-care portal. Results show that patients were more likely to adhere to a diurnal regimen than a variable regimen, and older patients, over the age of 60, were more adherent than younger patients, regardless of regimen. This suggests that common misconceptions should be reconsidered when prescribing Internet-based interventions for patients with chronic illness.

The design complexity of critical care ventilators (CCVs) can lead to use errors and patient harm. In this study, we present the results of a comparison of four CCVs from market leaders, using a rigorous methodology for the evaluation of use safety and user experience of medical devices. We carried out a comparative usability study of four CCVs: Hamilton G5, Puritan Bennett 980, Maquet SERVO-U, and Drager Evita V500. Forty-eight critical care respiratory therapists participated in this fully counterbalanced, repeated measures study. Participants completed seven clinical scenarios composed of 16 tasks on each ventilator. Use safety was measured by percentage of tasks with use errors or close calls (UE/CCs). User experience was measured by system usability and workload metrics, using the Post-Study System Usability Questionnaire (PSSUQ) and the National Aeronautics and Space Administration Task Load Index (NASA-TLX). Nine of 18 post hoc contrasts between pairs of ventilators were significant after Bonferroni correction, with effect sizes between 0.4 and 1.09 (Cohen’s d). There were significantly fewer UE/CCs with SERVO-U when compared to G5 (p = 0.044) and V500 (p = 0.020). Participants reported higher system usability for G5 when compared to PB980 (p = 0.035) and higher system usability for SERVO-U when compared to G5 (p

Background Multidisciplinary heart function clinics aim to improve self-care through patient education and to provide clinical management. Objective The objectives of the present study were to investigate the self-care and quality of life of patients attending a multidisciplinary heart function clinic and to explore the relationship between self-care and quality of life. Methods One hundred outpatients attending a multidisciplinary heart function clinic were asked to complete a questionnaire. The questionnaire included the Self-care of Heart Failure Index (SCHFI) and the Minnesota Living With Heart Failure Questionnaire, which were used to assess self-care behavior and quality of life, respectively. Self-care practices and perceived barriers were also assessed through semistructured interviews with each patient. Results : The returned questionnaires (n = 94) were used to compute the following SCHFI maintenance, management, and confidence scores: 60.8 (SD, 19.3), 62.0 (SD, 20.7), and 55.9 (SD, 19.7), respectively. Higher SCHFI scores indicate better self-care. None of the self-care dimensions reached the self-care adequacy cut point of 70. The average score on the Minnesota Living With Heart Failure Questionnaire was 49.9 (SD, 25.4), indicating a moderate health-related quality of life. Lower ejection fraction, older age, and better quality of life were associated with better self-care. Determinants of better quality of life were older age, better functional capacity, higher self-care confidence, and fewer comorbidities. The patient interviews revealed that better quality of life is associated with higher self-care confidence and barriers to self-care caused anxiety to the patients. The self-care barriers were found to include lack of self-care education, financial constraints, lack of perceived benefit, and low self-efficacy. Conclusions Patients attending a large multidisciplinary Canadian heart failure clinic do not perform adequate self-care as measured with the SCHFI and report only a moderate quality of life. Increasing self-care through education and tools that target self-care barriers are required and may help improve quality of life.

Background: Rising concern over the poor level of blood-pressure (BP) control among hypertensive patients has prompted searches for novel ways of managing hypertension. The objectives of this study were to develop and pilot-test a home BP tele-management system that actively engages patients in the process of care. Methods: Phase 1 involved a series of focus-group meetings with patients and primary care providers to guide the system’s development. In Phase 2, 33 diabetic patients with uncontrolled ambulatory hypertension were enrolled in a 4-month pilot study, using a before-and-after design to assess its effectiveness in lowering BP, its acceptability to users, and the reliability of home BP measurements. Results: The system, developed using commodity hardware, comprised a Bluetooth-enabled home BP monitor, a mobile phone to receive and transmit data, a central server for data processing, a fax-back system to send physicians’ reports, and a BP alerting system. In the pilot study, 24-h ambulatory BP fell by 11/5 (13/7 SD) mm Hg (both P .001), and BP control improved significantly. Substantially more home readings were received by the server than expected, based on the preset monitoring schedule. Of 42 BP alerts sent to patients, almost half (n 20) were due to low BP. Physicians received no critical BP alerts. Patients perceived the system as acceptable and effective. Conclusions: The encouraging results of this study provide a strong rationale for a long-term, randomized, clinical trial to determine whether this home BP tele-management system improves BP control in the community among patients with uncontrolled hypertension. Am J Hypertens 2007;20:942–948 © 2007 American Journal of Hypertension, Ltd.

Background Prevalence surveys have consistently found that the blood pressure control rate among people with hypertension is less than 25%. Studies of telemedicine as a means of providing care to hypertensive patients have shown that this approach is effective in lowering blood pressure. Major design flaws and high operating costs, however, have hindered its adoption by physicians and patients. Objectives In the present commentary, the field of telemedicine, as it pertains to hypertension management, is reviewed, and the investigators' experiences in developing a new telemedicine system are outlined. Methods An applied qualitative case study approach was used to determine the information needs for the design of a telemedicine system. Opinions were elicited separately from type 2 diabetic patients with hypertension (n=24) and family practitioners in active clinical practice (n=18). Results Physician and patient focus group meetings provided key information that led to changes in the prototype system. The low level of computer and Internet use by patients in everyday life and by physicians in practice-related activities precluded their inclusion in the design of the system for information retrieval and receiving clinical alerts. For patients, the mobile phone appeared to be an acceptable alternative. The only practical, automated means to disseminate reports and alerts to physicians was by fax, which was the most universally available device in a doctor's office. Conclusion This tightly focused qualitative study led to the development of design principles for a prototype system, increasing the likelihood of user acceptance and improving its effectiveness.

BackgroundThe high prevalence rate of asthma represents a major societal burden. Advancements in information technology continue to affect the delivery of patient care in all areas of medicine. Internet-based solutions, social media, and mobile technology could address some of the problems associated with increasing asthma prevalence. ObjectiveThis review evaluates Internet-based asthma interventions that were published between 2004 and October 2014 with respect to the use of behavioral change theoretical frameworks, applied clinical guidelines, and assessment tools. MethodsThe search term (Asthma AND [Online or Internet or Mobile or Application or eHealth or App]) was applied to six bibliographic databases (Ovid MEDLINE, PubMed, BioMed Central, ProQuest Computing, Web of Knowledge, and ACM Digital Library) including only English-language articles published between 2004 and October 2014. In total, 3932 articles matched the priori search terms and were reviewed by the primary reviewer based on their titles, index terms, and abstracts. The matching articles were then screened by the primary reviewer for inclusion or exclusion based on their abstract, study type, and intervention objectives with respect to the full set of priori inclusion and exclusion criteria; 331 duplicates were identified and removed. A total of 85 articles were included for in-depth review and the remaining 3516 articles were excluded. The primary and secondary reviewer independently reviewed the complete content of the 85 included articles to identify the applied behavioral change theories, clinical guidelines, and assessment tools. Findings and any disagreement between reviewers were resolved by in-depth discussion and through a consolidation process for each of the included articles. ResultsThe reviewers identified 17 out of 85 interventions (20%) where at least one model, framework, and/or construct of a behavioral change theory were applied. The review identified six clinical guidelines that were applied across 30 of the 85 interventions (35%) as well as a total of 21 assessment tools that were applied across 32 of the 85 interventions (38%). ConclusionsThe findings of this literature review indicate that the majority of published Internet-based interventions do not use any documented behavioral change theory, clinical guidelines, and/or assessment tools to inform their design. Further, it was found that the application of clinical guidelines and assessment tools were more salient across the reviewed interventions. A consequence, as such, is that many Internet-based asthma interventions are designed in an ad hoc manner, without the use of any notable evidence-based theoretical frameworks, clinical guidelines, and/or assessment tools.

Can an app help manage diabetes? We discuss how the advent of mobile health apps in connecting patients to providers is creating new opportunities for the management of diabetes. Although there are promising outcomes, there is still much to be learned about how such technology could be fully exploited.

Background The aim of this study was to determine whether digital video is suitable for the documentation of colonoscopy. Standards are required for the visual documentation of endoscopic findings and to optimize image quality while limiting file size and bandwidth requirements. Methods Video recordings of colonoscopy procedures were encoded using a common video compression method at selected data rates and resolutions. Twelve reviewers were selected, each of whom was assigned 8 video review sessions, each consisting of 5 colonoscopy procedures. The reviewers rated the following: level of confidence that the cecum was demonstrated, subjective quality of the video compared with actual videocolonoscopy, and whether the video was of "diagnostic quality." Results Reviewers were confident that the cecum was demonstrated in all cases except at the lowest data rate. The 1.0 Mbps standard interchange format video provided an optimal balance between quality and file size. Conclusions For the documentation of colonoscopy, 1.0 Mbps is acceptable and results in a file size of 7.5 Mbytes/min, which is manageable for most modern hospital and telehealth networks.

Objective Clinical protocols for basal rate testing and adjustment are needed for effective insulin pump therapy. We evaluated the effects of a continuous glucose monitoring (CGM)-based semiautomated basal algorithm on glycemia. Methods We developed and piloted a basal rate analyzer that interpreted CGM data from overnight fasts and recommended dose changes for subsequent nights. Subjects uploaded data online using sensor-augmented pumps for evaluation by the analyzer after each of 5 overnight fasts conducted over 2 to 8 weeks. It was designed to be conservative and iterative, making changes that did not exceed 10% at each iteration. The standard deviation and interquartile range of CGM values from midnight to 7 am (SD 12-7am and IQR 12-7am ) over 3 baseline and 3 postintervention nights, hypoglycemia incidence (CGM values Results Twenty subjects with mean ages of 38±13 years and A1C 7.6%±0.8% (60±8.7 mmol/mol) underwent the 5 iterations of basal assessments over 5±3 weeks. SD 12-7am and IQR 12-7am did not change from baseline to postintervention (1.57±0.8 to 1.63±0.8 mmol/L; p=0.35; 3.66±2.07 to 3.47±2.26 mmol/L; p=0.90). However, mean glucose values were lower between 2 to 3 am at baseline compared to postintervention; 3-night hypoglycemia incidence declined from 1.6±1.8 to 0.5±0.7 episodes (p=0.01), and A1C improved from 7.6%±0.8% to 7.4%±0.9% (60%±8.7% to 57%±9.8% mmol/mol; p=0.03). Conclusions The use of a basal rate analyzer was associated with reduced hypoglycemia and improved A1C. However, overnight glycemic stability was not improved. Further research into the efficacy of the CGM-based semiautomated algorithm is warranted.

Electroencephalography (EEG) testing in clinical labs makes use of large amplifiers and complex software for data acquisition. While there are new ambulatory electroencephalogram (EEG) systems, few have been directly compared to a gold standard system. Here, an ultra-low power wireless EEG system designed by Imec is tested against the gold standard Neuroscan SynAmps2 EEG system, recording simultaneously from the same laboratory cap prepared with electrode gel. The data was analyzed using correlation analysis for both time domain and frequency domain data. The analysis indicated a high Pearson's correlation coefficient (mean=0.957, median=0.985) with high confidence (mean P=0.002) for 10-second sets of data transformed to the frequency domain. The time domain results had acceptable Pearson's coefficient (mean=0.580, median =0.706) with high confidence (mean P=0.008).

Background: Effective management and care of diabetes is crucial to reducing associated risks such as heart disease and kidney failure. With increasing access and use of the Internet, online chronic disease management is being explored as a means of providing patients with support and the necessary tools to monitor and manage their disease. Objective: The objective of our study was to evaluate the experience of patients and providers using an online diabetes management portal for patients. Methods: Participants were recruited from a large sample population of 887 for a follow-up questionnaire to be completed after 6 months of using the patient portal. Participants were presented with the option to participate in an additional interview and, if the participant agreed, a time and date was scheduled for the interview. A 5-item, open-ended questionnaire was used to capture providers' opinions of the patient portal. Providers included general practitioners (GPs), nurses, nurse practitioners (NPs), dieticians, diabetes educators (DECs), and other clinical staff. Results: A total of 854 patients were consented for the questionnaire. Seventeen (8 male, 9 female) patients agreed to participate in a telephone interview. Sixty-four health care providers completed the five open-ended questions; however, an average of 48.2 responses were recorded per question. Four major themes were identified and will be discussed in this paper. These themes have been classified as: facilitators of disease management, barriers to portal use, patient-provider communication and relationship, and recommendations for portal improvements. Conclusions: This qualitative study shows that online chronic disease management portals increase patient access to information and engagement in their health care, but improvements in the portal itself may improve usability and reduce attrition. Furthermore, this study identifies a grey area that exists in the roles that GPs and AHPs should play in the facilitation of online disease management. [J Med Internet Res 2012;14(6):e158]

Lowering blood pressure reduces cardiovascular risk, yet hypertension is poorly controlled in diabetic patients. In a pilot study we demonstrated that a home blood pressure telemonitoring system, which provided self-care messages on the smartphone of hypertensive diabetic patients immediately after each reading, improved blood pressure control. Messages were based on care paths defined by running averages of transmitted readings. The present study tests the system's effectiveness in a randomized, controlled trial in diabetic patients with uncontrolled systolic hypertension. Of 244 subjects screened for eligibility, 110 (45%) were randomly allocated to the intervention (n=55) or control (n=55) group, and 105 (95.5%) completed the 1-year outcome visit. In the intention-to-treat analysis, mean daytime ambulatory systolic blood pressure, the primary end point, decreased significantly only in the intervention group by 9.1±15.6 mmHg (SD; P P P P =0.014). This study demonstrated that home blood pressure telemonitoring combined with automated self-care support reduced the blood pressure of diabetic patients with uncontrolled systolic hypertension and improved hypertension control. Home blood pressure monitoring alone had no effect on blood pressure. Promoting patient self-care may have negative psychological effects.

To characterise the nursing practices of vital signs collection and documentation in a general internal medicine environment to inform strategies for improving workflow design.Clinical workflow analysis is critical to identify barriers and opportunities in current processes. Analysis can guide the design and development of novel technological solutions to produce greater efficiencies and effectiveness in healthcare delivery. Research surrounding vital signs documentation workflow in general internal medicine environments has received very little attention making it difficult to compare the effectiveness of new technologies.Qualitative ethnographic analyses and quantitative time-motion study were conducted.Workflows of 24 nurses at three hospitals in five general internal medicine environments were captured, and timeliness of vital signs assessment and documentation was measured.Clinical assessment of vital signs was consistent, but the documentation process was highly variable within groups and between hospitals. Two themes characterised workflow barriers surrounding point-of-care documentation. First, a lack of standardised documentation methods for vital signs resulted in higher rates of transcription, increasing not only the likelihood of errors but delays in recording and accessibility of information. Second, despite advancements in electronic documentation systems, the observed system was not conducive to point-of-care documentation. Average electronic documentation was significantly longer than paper documentation. Nurses developed ad hoc workarounds that were inefficient and undermined the intent of electronic documentation.We have identified barriers and opportunities to improve the efficiency of nursing vital signs documentation. Changes in technology, workflows and environmental design allow for significant improvements and deserve further exploration.Attention to clinical practice and environments can improve the workflow of prompt vital signs documentation and increase clinical productivity and timeliness of information for clinical decisions, as well as minimising transcription errors leading to safer patient care.