Associations Between Psychosocial Needs, Carbohydrate-Counting Behavior, and App Satisfaction: A Randomized Crossover App Trial on 92 Adults With Diabetes.

To examine whether psychosocial needs in diabetes care are associated with carbohydrate counting and if carbohydrate counting is associated with satisfaction with diabetes applications' usability, a randomized crossover trial of 92 adults with type 1 or 2 diabetes requiring insulin therapy tested two top-rated diabetes applications, mySugr and OnTrack Diabetes. Survey responses on demographics, psychosocial needs (perceived competence, autonomy, and connectivity), carbohydrate-counting frequency, and application satisfaction were modeled using mixed-effect linear regressions to test associations. Participants ranged between 19 and 74 years old (mean, 54 years) and predominantly had type 2 diabetes (70%). Among the three tested domains of psychosocial needs, only competence-not autonomy or connectivity-was found to be associated with carbohydrate-counting frequency. No association between carbohydrate-counting behavior and application satisfaction was found. In conclusion, perceived competence in diabetes care is an important factor in carbohydrate counting; clinicians may improve adherence to carbohydrate counting with strategies designed to improve perceived competence. Carbohydrate-counting behavior is complex; its impact on patient satisfaction of diabetes application usability is multifactorial and warrants consideration of patient demographics such as sex as well as application features for automated carbohydrate counting.

Successful Change Management Strategies for Improving Diabetes Care Delivery Among High-Performing Practices.

PURPOSE: To learn how the highest-performing primary care practices manage change when implementing improvements to diabetes care delivery. METHODS: We ranked a total of 330 primary care practices submitting practice management assessments and diabetes reports to the Understanding Infrastructure Transformation Effects on Diabetes study in 2017 and 2019 by Optimal Diabetes Care performance. We ranked practices from the top quartile by greatest annual improvement to capture dynamic change. Starting with the top performers, we interviewed practice leaders to identify their most effective strategies for managing change. Interview transcripts were qualitatively analyzed to identify change management strategies. Saturation occurred when no new strategies were identified over 2 consecutive interviews. RESULTS: Ten of the top 13 practices agreed to interviews. We identified 199 key comments representing 48 key care management concepts. We also categorized concepts into 6 care management themes and 37 strategic approaches. We categorized strategic approaches into 13 distinct change management strategies. The most common strategies identified were (1) standardizing the care process, (2) performance awareness, (3) enhancing care teams, (4) health care organization participation, (5) improving reporting systems, (6) engaging staff and clinicians, (7) accountability for tasks, (8) engaging leadership, and (9) tracking change. Care management themes identified by most practices included proactive care, improving patient relationships, and previsit planning. CONCLUSIONS: Top-performing primary care practices identify a similar group of strategies as important for managing change during quality improvement activities. Practices involved in diabetes improvement activities, and perhaps other chronic conditions, should consider adopting these change management strategies.

App Design Features Important for Diabetes Self-management as Determined by the Self-Determination Theory on Motivation: Content Analysis of Survey Responses From Adults Requiring Insulin Therapy.

BACKGROUND: Using a diabetes app can improve glycemic control; however, the use of diabetes apps is low, possibly due to design issues that affect patient motivation. OBJECTIVE: This study aimed to describes how adults with diabetes requiring insulin perceive diabetes apps based on 3 key psychological needs (competence, autonomy, and connectivity) described by the Self-Determination Theory (SDT) on motivation. METHODS: This was a qualitative analysis of data collected during a crossover randomized laboratory trial (N=92) testing 2 diabetes apps. Data sources included (1) observations during app testing and (2) survey responses on desired app features. Guided by the SDT, coding categories included app functions that could address psychological needs for motivation in self-management: competence, autonomy, and connectivity. RESULTS: Patients described design features that addressed needs for competence, autonomy, and connectivity. To promote competence, electronic data recording and analysis should help patients track and understand blood glucose (BG) results necessary for planning behavior changes. To promote autonomy, BG trend analysis should empower patients to set safe and practical personalized behavioral goals based on time and the day of the week. To promote connectivity, app email or messaging function could share data reports and communicate with others on self-management advice. Additional themes that emerged are the top general app designs to promote positive user experience: patient-friendly; automatic features of data upload; voice recognition to eliminate typing data; alert or reminder on self-management activities; and app interactivity of a sound, message, or emoji change in response to keeping or not keeping BG in the target range. CONCLUSIONS: The application of the SDT was useful in identifying motivational app designs that address the psychological needs of competence, autonomy, and connectivity. User-centered design concepts, such as being patient-friendly, differ from the SDT because patients need a positive user experience (ie, a technology need). Patients want engaging diabetes apps that go beyond data input and output. Apps should be easy to use, provide personalized analysis reports, be interactive to affirm positive behaviors, facilitate data sharing, and support patient-clinician communication.

Assessing Progress Toward the Vision of a Comprehensive, Shared Electronic Care Plan: Scoping Review.

BACKGROUND: Care plans are central to effective care delivery for people with multiple chronic conditions. But existing care plans-which typically are difficult to share across care settings and care team members-poorly serve people with multiple chronic conditions, who often receive care from numerous clinicians in multiple care settings. Comprehensive, shared electronic care (e-care) plans are dynamic electronic tools that facilitate care coordination and address the totality of health and social needs across care contexts. They have emerged as a potential way to improve care for individuals with multiple chronic conditions. OBJECTIVE: To review the landscape of e-care plans and care plan-related initiatives that could allow the creation of a comprehensive, shared e-care plan and inform a joint initiative by the National Institutes of Health and the Agency for Healthcare Research and Quality to develop e-care planning tools for people with multiple chronic conditions. METHODS: We conducted a scoping review, searching literature from 2015 to June 2020 using Scopus, Clinical Key, and PubMed; we also searched the gray literature. To identify initiatives potentially missing from this search, we interviewed expert informants. Relevant data were then identified and extracted in a structured format for data synthesis and analysis using an expanded typology of care plans adapted to our study context. The extracted data included (1) the perspective of the initiatives; (2) their scope, (3) network, and (4) context; (5) their use of open syntax standards; and (6) their use of open semantic standards. RESULTS: We identified 7 projects for e-care plans and 3 projects for health care data standards. Each project provided critical infrastructure that could be leveraged to promote the vision of a comprehensive, shared e-care plan. All the e-care plan projects supported both broad goals and specific behaviors; 1 project supported a network of professionals across clinical, community, and home-based networks; 4 projects included social determinants of health. Most projects specified an open syntax standard, but only 3 specified open semantic standards. CONCLUSIONS: A comprehensive, shared, interoperable e-care plan has the potential to greatly improve the coordination of care for individuals with multiple chronic conditions across multiple care settings. The need for such a plan is heightened in the wake of the ongoing COVID-19 pandemic. While none of the existing care plan projects meet all the criteria for an optimal e-care plan, they all provide critical infrastructure that can be leveraged as we advance toward the vision of a comprehensive, shared e-care plan. However, critical gaps must be addressed in order to achieve this vision.

Health information technology to improve care for people with multiple chronic conditions.

OBJECTIVE: To review evidence regarding the use of Health Information Technology (health IT) interventions aimed at improving care for people living with multiple chronic conditions (PLWMCC) in order to identify critical knowledge gaps. DATA SOURCES: We searched MEDLINE, CINAHL, PsycINFO, EMBASE, Compendex, and IEEE Xplore databases for studies published in English between 2010 and 2020. STUDY DESIGN: We identified studies of health IT interventions for PLWMCC across three domains as follows: self-management support, care coordination, and algorithms to support clinical decision making. DATA COLLECTION/EXTRACTION METHODS: Structured search queries were created and validated. Abstracts were reviewed iteratively to refine inclusion and exclusion criteria. The search was supplemented by manually searching the bibliographic sections of the included studies. The search included a forward citation search of studies nested within a clinical trial to identify the clinical trial protocol and published clinical trial results. Data were extracted independently by two reviewers. PRINCIPAL FINDINGS: The search yielded 1907 articles; 44 were included. Nine randomized controlled trials (RCTs) and 35 other studies including quasi-experimental, usability, feasibility, qualitative studies, or development/validation studies of analytic models were included. Five RCTs had positive results, and the remaining four RCTs showed that the interventions had no effect. The studies address individual patient engagement and assess patient-centered outcomes such as quality of life. Few RCTs assess outcomes such as disability and none assess mortality. CONCLUSIONS: Despite a growing body of literature on health IT interventions or multicomponent interventions including a health IT component for chronic disease management, current evidence for applying health IT solutions to improve care for PLWMCC is limited. The body of literature included in this review provides critical information on the state of the science as well as the many gaps that need to be filled for digital health to fulfill its promise in supporting care delivery that meets the needs of PLWMCC.

Strategies and Factors Associated With Top Performance in Primary Care for Diabetes: Insights From a Mixed Methods Study.

PURPOSE: The aim of this study was to determine what strategies and factors are most important for high performance in the primary care of patients with diabetes. METHODS: We performed a mixed-methods, cross-sectional, observational analysis of interviews and characteristics of primary care clinics in Minnesota and bordering areas. We compared strategies, facilitators, and barriers identified by 31 leaders of 17 clinics in high-, middle-, and low-performance quartiles on a standardized composite measure of diabetes outcomes for 416 of 586 primary care clinics. Semistructured interview data were combined with quantitative data regarding clinic performance and a survey of the presence of care management processes. RESULTS: The interview analysis identified 10 themes providing unique insights into the factors and strategies characterizing the 3 performance groups. The main difference was the degree to which top-performing clinics used patient data to guide proactive and outreach methods to intensify treatment and monitor effect. Top clinics also appeared to view visit-based care management processes as necessary but insufficient, whereas all respondents regarded being part of a large system as mostly helpful. CONCLUSIONS: Top-performing clinic approaches to diabetes care differ from lower-performing clinics primarily by emphasizing data-driven proactive outreach to patients to intensify treatment. Although confirmatory studies are needed, clinical leaders should consider the value of this paradigm shift in approach to care.

Content Analysis: First-Time Patient User Challenges with Top-Rated Commercial Diabetes Apps.

Background/Introduction: Using a mobile application (app) may improve diabetes self-management. However, the use of diabetes apps is low, possibly due to design and usability issues. The purpose of this study was to identify barriers to app use among adult patients with diabetes who were testing diabetes apps for the first time. Materials and Methods: We conducted a content analysis of observation notes and patient comments collected during the testing of two top commercially available diabetes apps as part of a crossover randomized trial. Participants were adult patients with type 1 or type 2 diabetes on insulin therapy. We analyzed field notes and transcriptions of audio recordings. Open coding derived categories of usability issues, which then were grouped into themes and subthemes on usability problem types. Results: A total of 92 adult Android smartphone users were recruited online (e.g., Facebook) and in-person postings. Three major themes described problems with data input, app report display and presentation, and self-learning options. Data entry modes were problematic because of overcrowded app screens, complicated "save data" steps, and a lack of data entry confirmation. The app icons, wording, entry headings, and analysis reports were not intuitive to understand. Participants wanted self-learning options (e.g., pop-up messages) during app use. Conclusions: Patient testing of top commercially available diabetes apps revealed key usability design issues in data entry, app report, and self-help learning options. Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.

The Effect of Depression and Rurality on Diabetes Control.

BACKGROUND: Having depression and living in a rural environment have separately been associated with poor diabetes outcomes, but there little is known about the interaction between the 2 risk factors. This study investigates the association of depression and rurality with glycemic control in adults, as well as their interaction. METHODS: This is a repeated cross-sectional study with data collected from 2010 to 2017 (n = 1,697,173 patient-year observations), comprising a near-complete census of patients with diabetes in Minnesota. The outcome of interest was glycemic control defined as hemoglobin A1c under 8%. We used a logit model with clinic-level random effects to predict glycemic control as a function of depression, patient rurality, and their interaction, adjusted for differences in observed characteristics of the patient, clinic, and patient's neighborhood. RESULTS: Having depression was associated with lower probability of achieving glycemic control (P < .001). Although rurality alone had no association with glycemic control, significant interactions existed between depression and rurality. Living in a small rural town mitigated the negative association between depression and glycemic control (P < .001). CONCLUSION: Although patients with depression had poorer glycemic control, living in a small rural town reduced the negative association between depression and glycemic control.

Usability Evaluation of Four Top-Rated Commercially Available Diabetes Apps for Adults With Type 2 Diabetes.

Despite the many diabetes applications available, the rate of use is low, which may be associated with design issues. This study examined app usability compliance with heuristic design principles, guided by the Self-determination Theory on motivation. Four top-rated commercially available apps (Glucose Buddy, MyNetDiary, mySugr, and OnTrack) were tested for data recording, blood glucose analysis, and data sharing important for diabetes competence, autonomy, and connection with a healthcare provider. Four clinicians rated each app's compliance with Nielsen's 10 principles and its usability using the System Usability Scale. All four apps lacked one task function related to diabetes care competence or autonomy. Experts ranked app usability rated with the System Usability Scale: OnTrack (61) and Glucose Buddy (60) as a "D" and MyNetDairy (41) and mySugr (15) as an "F." A total of 314 heuristic violations were identified. The heuristic principle violated most frequently was "Help and Documentation" (n = 50), followed by "Error Prevention" (n = 45) and "Aesthetic and Minimalist Design" (n = 43). Four top-rated diabetes apps have "marginally acceptable" to "completely unacceptable." Future diabetes app design should target patient motivation and incorporate key heuristic design principles by providing tutorials with a help function, eliminating error-prone operations, and providing enhanced graphical or screen views.

Tool to Aid Patients in Selecting a Liver Transplant Center.

Variations in candidate and donor acceptance criteria may influence access and mortality for liver transplantation. We sought to understand how recipient and donor characteristics vary across centers and how patients interpret this information, and we used these data to develop a tool to provide tailored information to candidates seeking a center (www.transplantcentersearch.org). We analyzed liver recipient data from the Scientific Registry of Transplant Recipients to determine how recipient and donor characteristics (eg, age, Medicaid use, and human immunodeficiency virus status) varied across programs. Data included recipients and donors at each US program between January 1, 2015, and December 31, 2017. The variation in characteristics was plotted with centers stratified by total transplant volume and by volume of each characteristic. A subset of characteristics was plotted to show variation over 3 years. We created mockups of potential reports displaying recipient characteristics alongside pretransplant and posttransplant outcomes and solicited feedback at patient and family interviews and focus groups, which included 39 individuals: 10 pilot interviews with candidates seeking liver transplant at the University of Minnesota-Fairview (UMNF) and 5 focus groups with 13 UMNF candidates, 6 UMNF family members, and 10 national recipients. Transcripts were analyzed using a thematic analysis. Several themes emerged: (1) Candidates experience gaps in existing education about center options; (2) patients requested information about how selection criteria might impact access to transplant; and (3) information tailored to a candidate's medical characteristics can inform decisions. Characteristics shown on mockups varied across centers (P < 0.01). Variation was widespread for small and large centers. In conclusion, variation exists in recipient and donor characteristics across centers. Liver transplant patients provide positive feedback upon viewing patient-specific search tools.

Influence of Patient Characteristics and Psychological Needs on Diabetes Mobile App Usability in Adults With Type 1 or Type 2 Diabetes: Crossover Randomized Trial.

BACKGROUND: More than 1100 diabetes mobile apps are available, but app usage by patients is low. App usability may be influenced by patient factors such as age, sex, and psychological needs. OBJECTIVE: Guided by Self-Determination Theory, the purposes of this study were to (1) assess the effect of patient characteristics on app usability, and (2) determine whether patient characteristics and psychological needs (competence, autonomy, and connectivity)-important for motivation in diabetes care-are associated with app usability. METHODS: Using a crossover randomized design, 92 adults with type 1 or 2 diabetes tested two Android apps (mySugr and OnTrack) for seven tasks including data entry, blood glucose (BG) reporting, and data sharing. We used multivariable linear regression models to examine associations between patient characteristics, psychological needs, user satisfaction, and user performance (task time, success, and accuracy). RESULTS: Participants had a mean age of 54 (range 19-74) years, and were predominantly white (62%, 57/92), female (59%, 54/92), with type 2 diabetes (70%, 64/92), and had education beyond high school (67%, 61/92). Participants rated an overall user satisfaction score of 62 (SD 18), which is considered marginally acceptable. The satisfaction mean score for each app was 55 (SD 18) for mySugr and 68 (SD 15) for OnTrack. The mean task completion time for all seven tasks was 7 minutes, with a mean task success of 82% and an accuracy rate of 68%. Higher user satisfaction was observed for patients with less education (P=.04) and those reporting more competence (P=.02), autonomy (P=.006), or connectivity with a health care provider (P=.03). User performance was associated with age, sex, education, diabetes duration, and autonomy. Older patients required more time (95% CI 1.1-3.2) and had less successful task completion (95% CI 3.5-14.3%). Men needed more time (P=.01) and more technical support than women (P=.04). High school education or less was associated with lower task success (P=.003). Diabetes duration of ≥10 years was associated with lower task accuracy (P=.02). Patients who desired greater autonomy and were interested in learning their patterns of BG and carbohydrates had greater task success (P=.049). CONCLUSIONS: Diabetes app usability was associated with psychological needs that are important for motivation. To enhance patient motivation to use diabetes apps for self-management, clinicians should address competence, autonomy, and connectivity by teaching BG pattern recognition and lifestyle planning, customizing BG targets, and reviewing home-monitored data via email. App usability could be improved for older male users and those with less education and greater diabetes duration by tailoring app training and providing ongoing technical support.

Cellular metabolism constrains innate immune responses in early human ontogeny.

Pathogen immune responses are profoundly attenuated in fetuses and premature infants, yet the mechanisms underlying this developmental immaturity remain unclear. Here we show transcriptomic, metabolic and polysome profiling and find that monocytes isolated from infants born early in gestation display perturbations in PPAR-γ-regulated metabolic pathways, limited glycolytic capacity and reduced ribosomal activity. These metabolic changes are linked to a lack of translation of most cytokines and of MALT1 signalosome genes essential to respond to the neonatal pathogen Candida. In contrast, they have little impact on house-keeping phagocytosis functions. Transcriptome analyses further indicate a role for mTOR and its putative negative regulator DNA Damage Inducible Transcript 4-Like in regulating these metabolic constraints. Our results provide a molecular basis for the broad susceptibility to multiple pathogens in these infants, and suggest that the fetal immune system is metabolically programmed to avoid energetically costly, dispensable and potentially harmful immune responses during ontogeny.

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review.

OBJECTIVES: To assess the usability and clinical effectiveness of diabetes mobile applications (diabetes apps) developed for adults with type 2 diabetes. METHOD: A systematic review of the usability and effectiveness of diabetes apps was conducted. Searches were performed using MEDLINE, EMBASE, COMPENDEX, and IEEE XPLORE for articles published from January 1, 2011, to January 17, 2017. Search terms included: diabetes, mobile apps, and mobile health (mHealth). RESULTS: The search yielded 723 abstracts of which seven usability studies and ten clinical effectiveness studies met the inclusion criteria from 20 publications. Usability, as measured by satisfaction ratings from experts and patients, ranged from 38% to 80%. Usability problem ratings ranged from moderate to catastrophic. Top usability problems are multi-steps task, limited functionality and interaction, and difficult system navigation. Clinical effectiveness, measured by reductions in HbA1c, ranged from 0.15% to 1.9%. CONCLUSION: Despite meager satisfaction ratings and major usability problems, there is some limited evidence supporting the effectiveness of diabetes apps to improve glycemic control for adults with type 2 diabetes. Findings strongly suggest that efforts to improve user satisfaction, incorporate established principles of health behavior change, and match apps to user characteristics will increase the therapeutic impact of diabetes apps.

Comparison of consumer derived evidence with an omaha system evidence-based practice guideline for community dwelling older adults.

Consumer involvement in healthcare is critical to support continuity of care for consumers to manage their health while transitioning from one care setting to another. Validation of evidence-based practice (EBP) guideline by consumers is essential to achieving consumer health goals over time that is consistent with their needs and preferences. The purpose of this study was to compare an Omaha System EBP guideline for community dwelling older adults with consumer-derived evidence of their ongoing needs, resources, and strategies after home care discharge. All identified problems were relevant for all patients except for Neglect and Substance use. Ten additional problems were identified from the interviews, five of which affected at least 10% of the participants. Consumer derived evidence both validated and expanded EBP guidelines; thus further emphasizing the importance of consumer involvement in the delivery of home healthcare.

Humanization of a chicken anti-IL-12 monoclonal antibody.

Chicken anti-IL-12 monoclonal antibodies were isolated by phage display using spleen cells from a chicken immunized with human and mouse IL-12 as a source for library construction. One of the chicken monoclonal antibodies, DD2, exhibited binding to both human and mouse IL-12 in the single-chain Fv form and also after conversion to chicken-human chimeric IgG1/lambda antibody. The chicken DD2 variable regions were humanized by transferring their CDRs and several framework amino acids onto human acceptor variable regions. In the Vlambda, six chicken framework amino acids were identified to be important for the conformation of the CDR structure by computer modeling and therefore were retained in the humanized form; likewise, five chicken amino acids in the VH framework regions were retained in the humanized VH. The affinities of humanized DD2 IgG1/lambda to human and mouse IL-12 measured by competitive binding were nearly identical to those of chicken-human chimeric DD2 IgG1/lambda. This work demonstrates that humanization of chicken monoclonal antibodies assisted by computer modeling is possible, leading to a new way to generate therapeutic humanized antibodies against antigens to which the rodent immune system may fail to efficiently raise high affinity antibodies.