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.

Assessing the use of prescription drugs and dietary supplements in obese respondents in the National Health and Nutrition Examination Survey.

INTRODUCTION: Obesity is a common disease and a known risk factor for many other conditions such as hypertension, type 2 diabetes, and cancer. Treatment options for obesity include lifestyle changes, pharmacotherapy, and surgical interventions such as bariatric surgery. In this study, we examine the use of prescription drugs and dietary supplements by the individuals with obesity. METHODS: We conducted a cross-sectional analysis of the National Health and Nutrition Examination Survey (NHANES) data 2003-2018. We used multivariate logistic regression to analyze the correlations of demographics and obesity status with the use of prescription drugs and dietary supplement use. We also built machine learning models to classify prescription drug and dietary supplement use using demographic data and obesity status. RESULTS: Individuals with obesity are more likely to take cardiovascular agents (OR = 2.095, 95% CI 1.989-2.207) and metabolic agents (OR = 1.658, 95% CI 1.573-1.748) than individuals without obesity. Gender, age, race, poverty income ratio, and insurance status are significantly correlated with dietary supplement use. The best performing model for classifying prescription drug use had the accuracy of 74.3% and the AUROC of 0.82. The best performing model for classifying dietary supplement use had the accuracy of 65.3% and the AUROC of 0.71. CONCLUSIONS: This study can inform clinical practice and patient education of the use of prescription drugs and dietary supplements and their correlation with obesity.

Clinical Data Repositories: Primary Sources of Drug-to-Drug Interaction Detection and Risk Assessment.

Background: Polypharmacy can be a source of adverse drug events including those caused by drug to drug interaction (DDI) exposures. Web-based DDI databases are available to researchers for the identification of potential DDI exposures. Rather than relying on potentially incomplete DDI databases, large clinical data repositories (CDR) which are integrated data sources fed with millions of heterogeneous electronic health records (EHRs) containing real-world data should be leveraged for data driven DDI identification. Objective: To explore and validate the viability of clinical data repositories as data driven resources for clinically important adverse drug events detection and surveillance. Methods: This work leverages a minimum clinical data set from the University of Minnesota's CDR to identify drugs that have statin to drug interaction (SDI) potential and compares the findings with results of web based DDI databases. Using an SDI identification matrix, we identified several potential novel SDI drugs that were not mentioned in the web-based sources but explored through our study as drugs with SDI potential. Results: Drugs flagged by our SDI identification matrix but not mentioned in the web-based sources include Lysine, Ketotifen, Latanoprost, Methylcellulose, Oxazepam, Linseed Oil, and others. Conclusion: Our findings identified potential gaps regarding the completeness, currency, and overall reliability of open source and commercial DDI databases. CDRs can be a primary source for identifying drug to drug interactions. Keywords: clinical data repository, drug to drug interaction databases, drug to drug interaction, statin to drug interaction, polypharmacy, statin to drug interaction identification matrix, adverse drug event, statin.

iDISK: the integrated DIetary Supplements Knowledge base.

OBJECTIVE: To build a knowledge base of dietary supplement (DS) information, called the integrated DIetary Supplement Knowledge base (iDISK), which integrates and standardizes DS-related information from 4 existing resources. MATERIALS AND METHODS: iDISK was built through an iterative process comprising 3 phases: 1) establishment of the content scope, 2) development of the data model, and 3) integration of existing resources. Four well-regarded DS resources were integrated into iDISK: The Natural Medicines Comprehensive Database, the "About Herbs" page on the Memorial Sloan Kettering Cancer Center website, the Dietary Supplement Label Database, and the Natural Health Products Database. We evaluated the iDISK build process by manually checking that the data elements associated with 50 randomly selected ingredients were correctly extracted and integrated from their respective sources. RESULTS: iDISK encompasses a terminology of 4208 DS ingredient concepts, which are linked via 6 relationship types to 495 drugs, 776 diseases, 985 symptoms, 605 therapeutic classes, 17 system organ classes, and 137 568 DS products. iDISK also contains 7 concept attribute types and 3 relationship attribute types. Evaluation of the data extraction and integration process showed average errors of 0.3%, 2.6%, and 0.4% for concepts, relationships and attributes, respectively. CONCLUSION: We developed iDISK, a publicly available standardized DS knowledge base that can facilitate more efficient and meaningful dissemination of DS knowledge.

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.

Association of Testosterone Therapy With Risk of Venous Thromboembolism Among Men With and Without Hypogonadism.

Importance: Testosterone therapy is increasingly prescribed in patients without a diagnosis of hypogonadism. This therapy may be associated with increased risk of venous thromboembolism (VTE) through several mechanisms, including elevated hematocrit levels, which increase blood viscosity. Objective: To assess whether short-term testosterone therapy exposure is associated with increased short-term risk of VTE in men with and without evidence of hypogonadism. Design, Setting, and Participants: This case-crossover study analyzed data on 39 622 men from the IBM MarketScan Commercial Claims and Encounter Database and the Medicare Supplemental Database from January 1, 2011, to December 31, 2017, with 12 months of follow-up. Men with VTE cases who were free of cancer at baseline and had 12 months of continuous enrollment before the VTE event were identified by International Classification of Diseases codes. Men in the case period were matched with themselves in the control period. Case periods of 6 months, 3 months, and 1 month before the VTE events were defined, with equivalent control periods (6 months, 3 months, and 1 month) in the 6 months before the case period. Exposures: National drug codes were used to identify billed testosterone therapy prescriptions in the case period (0-6 months before the VTE) and the control period (6-12 months before the VTE). Main Outcomes and Measures: The main outcome in this case-only experiment was first VTE event stratified by the presence or absence of hypogonadism. Results: A total of 39 622 men (mean [SD] age, 57.4 [14.2] years) were enrolled in the study, and 3110 men (7.8%) had evidence of hypogonadism. In age-adjusted models, testosterone therapy use in all case periods was associated with a higher risk of VTE in men with (odds ratio [OR], 2.32; 95% CI, 1.97-2.74) and without (OR, 2.02; 95% CI, 1.47-2.77) hypogonadism. Among men without hypogonadism, the point estimate for testosterone therapy and VTE risk in the 3-month case period was higher for men younger than 65 years (OR, 2.99; 95% CI, 1.91-4.68) than for older men (OR, 1.68; 95% CI, 0.90-3.14), although this interaction was not statistically significant (P = .14). Conclusions and Relevance: Testosterone therapy was associated with an increase in short-term risk for VTE among men with and without hypogonadism, with some evidence that the association was more pronounced among younger men. These findings suggest that caution should be used when prescribing testosterone therapy.

Analyzing Operative Note Structure in Development of a Section Header Resource.

Operative notes contain essential details of surgical procedures and are an important form of clinical documentation. Sections within operative notes segment provide high level note structure. We evaluated the HL7 Implementation Guide for Clinical Document Architecture Release 2.0 Operative Note Draft Standard for Trial Use (HL7-ON DSTU) Release 1 as well as Logical Observation Identifiers Names and Codes (LOINC®) section names on 384 unique section headers from 362,311 operative notes. Overall, HL7-ON DSTU alone and HL7-ON DSTU with LOINC® section headers covered 66% and 79% of sections headers (93% and 98% of header instances), respectively. Section headers contained large numbers of synonyms, formatting variation, and variation of word forms, as well as smaller numbers of compound sections and issues with mismatches in header granularity. Robust operative note section mapping is important for clinical note interoperability and effective use of operative notes by natural language processing systems. The resulting operative note section resource is made publicly available.

Validation of pre-operative patient self-assessment of cardiac risk for non-cardiac surgery: foundations for decision support.

OBJECTIVES: To better characterize patient understanding of their risk of cardiac complications from non-cardiac surgery and to develop a patient driven clinical decision support system for preoperative patient risk management. METHODS: A patient-driven preoperative self-assessment decision support tool for perioperative assessment was created. Patient' self-perception of cardiac risk and self-report data for risk factors were compared with gold standard preoperative physician assessment to evaluate agreement. RESULTS: The patient generated cardiac risk profile was used for risk score generation and had excellent agreement with the expert physician assessment. However, patient subjective self-perception risk of cardiovascular complications had poor agreement with expert assessment. CONCLUSION: A patient driven cardiac risk assessment tool provides a high degree of agreement with expert provider assessment demonstrating clinical feasibility. The limited agreement between provider risk assessment and patient self-perception underscores a need for further work including focused preoperative patient education on cardiac risk.

Patient-specific surgical outcomes assessment using population-based data analysis for risk model development.

Optimal surgical planning and decision making surrounding surgical interventions requires patient-specific risk assessment which incorporates patient pre-operative clinical assessment and clinical literature. In this paper, we utilized population-based data analysis to construct surgical outcome predictive models for spinal fusion surgery using hospital, patient and admission characteristics. We analyzed population data from the Nationwide Inpatient Sample (NIS) -a nationally representative database- to identify data elements affecting inpatient mortality, length of stay, and disposition status for patients receiving spinal fusion surgery in the years 2004-2008. In addition to outcomes assessment, we want to make the analytic model results available to clinicians and researchers for pre-operative surgical risk assessment, hospital resource allocation, and hypothesis generation for future research without an individual patient data management burden. Spinal fusion was the selected prototype procedure due to it being a high volume and typically inpatient procedure where patient risk factors will likely affect clinical outcomes.

Anaemia following initiation of androgen deprivation therapy for metastatic prostate cancer: a retrospective chart review.

OBJECTIVE: Haemoglobin levels often decline into the anaemic range with androgen deprivation therapy (ADT). We conducted a chart review of patients receiving ADT for metastatic prostate cancer to assess anaemia-related symptoms. METHODS: 135 stage IV prostate cancer cases were reviewed for treatment type; haemoglobin values before and after treatment; and symptoms of anaemia. Mean haemoglobin levels before and after for all treatment forms, for leuprolide alone, and for combination leuprolide/bicalutamide were calculated and evaluated for significant differences. The numbers of patients developing symptoms were recorded and the effects of specific therapies evaluated. RESULTS: For all ADT treated patients, mean haemoglobin declined by -1.11 g/dL (p<.0001). Leuprolide-alone treated patients had a mean decline of -1.66 g/dL (p<0.0001). Leuprolide and bicalutamide combination treatment caused a mean decline of -0.78 g/dL (p=0.0426). 16 of 43 patients had anemia symptoms. Contingency analysis with Fisher's exact test shows patients receiving leuprolide therapy alone versus other forms of ADT were significantly less likely to have symptoms (chi(2)=0.0190). CONCLUSIONS: The present study confirms that ADT results in a significant drop in haemoglobin levels into the anaemic range. A number of patients become symptomatic from this change. Practitioners should monitor haemoglobin levels, and treat symptomatic patients.