Efficiency, Efficacy, and Power in the Implementation of a Medication Adherence Aid.

Nonadherence to medication regimens is common, with approximately 50% of patients not taking their medications as prescribed. The Universal Medication Schedule (UMS) is a set of standardized, evidence-based, and patient-centered instructions for pill-form medications that has demonstrated improvements in adherence by promoting patient comprehension. An urban, publicly funded, integrated health care system attempted to adopt UMS labeling but had limited success at its largest pilot site, which was a safety-net health care system's outpatient pharmacy. To assess barriers to implementation, we engaged pharmacists at this site in group interviews. We thematically analyzed transcripts by integrating sociological work on standardization with grounded theory methodologies. In addition to lacking technological infrastructure, tensions among efficiency, efficacy, and effectiveness, and tension between individual/biomedical versus population health perspectives emerged as barriers to implementation. Additionally, we discovered that hierarchies of professional power impeded uptake. For successful implementation of evidence-based practices for vulnerable populations in resource-poor settings, efforts must anticipate and reconcile the tensions among conflicting demands, professional hierarchies, and divergent orientations to patient care. [HLRP: Health Literacy Research and Practice. 2018;2(3):e128-e131.]

The Office of Combination Products: Its Roots, Its Creation, and Its Role

The Office of Combination Products (OCP), within the Food and Drug Administration (FDA), was created formally by statute in December, 2002. Upon its creation, the Office became broadly responsible for overseeing the regulation of combination products, or products that involve components that would normally be regulated under different FDA Centers. But the statutory creation of this Office in one day represented the culmination of nearly sixty-five years of both technological advancement in the products submitted to the FDA and amassed experience within the FDA and its administrative predecessors for managing those products in the name of the public safety. To understand the need for this Office and its primary goals of timely, effective and clear regulation of these groundbreaking technologies, the history of the FDA with respect to the advent of these combination products must be examined chronologically. Drafts of statutes, administrative proposals offered for public comment, and lengthy debates from Capitol Hill all illustrate the journey that led inevitably to the OCP as a final destination. Nearly twenty-four months have passed since the OCP was created, so an analysis of its initial progress through an explanation of the changes it has effected is necessary. Both combination product manufacturers and FDA jurisdiction officers have benefited from industry guidances, enhanced inter-Center communication, and a wealth of expertise provided by FDA employees eager to streamline the regulatory pathways to be navigated. Thus, the next three years within the OCP would seem to promise similar success for product manufacturers, the FDA and the American public

Branching Exponents of Synthetic Vascular Trees under Different Optimality Principles

Objective: The branching behavior of vascular trees is often characterized using Murray's law. We investigate its validity using synthetic vascular trees generated under global optimization criteria. Methods: Our synthetic tree model does not incorporate Murray's law explicitly. Instead, we show that its validity depends on properties of the optimization model and investigate the effects of different physical constraints and optimization goals on the branching exponent that is now allowed to vary locally. In particular, we include variable blood viscosity due to the Fåhræus–Lindqvist effect and enforce an equal pressure drop between inflow and the micro-circulation. Using our global optimization framework, we generate vascular trees with over one million terminal vessels and compare them against a detailed corrosion cast of the portal venous tree of a human liver. Results: Murray's law is fulfilled when no additional constraints are enforced, indicating its validity in this setting. Variable blood viscosity or equal pressure drop lead to different optima but with the branching exponent inside the experimentally predicted range between 2.0 and 3.0. The validation against the corrosion cast shows good agreement from the portal vein down to the venules. Conclusion: Not enforcing Murray's law increases the predictive capabilities of synthetic vascular trees, and in addition reduces the computational cost. Significance: The ability to study optimal branching exponents across different scales can improve the functional assessment of organs

Acoustic observations of vertical and horizontal swimming velocities of a diel migrator

A strong sound scattering layer which underwent diel vertical migration was observed over 176 days using a bottom-mounted 600 kHz ADCP at a depth of approximately 285 m on the upper continental slope. Average observed descent times of the scatterers were within 12 minutes of sunrise and average ascent times were within 13 minutes of sunset. Average ascent speeds progressively increased away from the bed and approached 6 cm/s. Average descent speeds similarly reached a maximum of ∼6 cm/s. Horizontal velocities of the scatterers during vertical migration were found to be smaller than ambient velocities (by up to 3 cm/s), and it is inferred that the migrators were swimming horizontally against the flow. Horizontal velocities of the scatterers during time intervals when the layer was near the seafloor were found to be southwest (up to 3 cm/s), and onshelf (up to 1.7 cm/s) relative to the flow above the layer. Swimming velocities were independent of alongshelf flow direction, counter to the hypothesis that the scatterers sought to maintain their position by swimming against the flow

Obesity and the food environment: income and ethnicity differences among people with diabetes: the Diabetes Study of Northern California (DISTANCE).

ObjectiveIt is unknown whether any association between neighborhood food environment and obesity varies according to individual income and/or race/ethnicity. The objectives of this study were to test whether there was an association between food environments and obesity among adults with diabetes and whether this relationship differed according to individual income or race/ethnicity.Research design and methodsSubjects (n = 16,057) were participants in the Diabetes Study of Northern California survey. Kernel density estimation was used to create a food environment score for each individual's residence address that reflected the mix of healthful and unhealthful food vendors nearby. Logistic regression models estimated the association between the modeled food environment and obesity, controlling for confounders, and testing for interactions between food environment and race/ethnicity and income.ResultsThe authors found that more healthful food environments were associated with lower obesity in the highest income groups (incomes 301-600% and >600% of U.S. poverty line) among whites, Latinos, and Asians. The association was negative, but smaller and not statistically significant, among high-income blacks. On the contrary, a more healthful food environment was associated with higher obesity among participants in the lowest-income group (<100% poverty threshold), which was statistically significant for black participants in this income category.ConclusionsThese findings suggest that the availability of healthful food environments may have different health implications when financial resources are severely constrained

Maximum-likelihood absorption tomography

Maximum-likelihood methods are applied to the problem of absorption tomography. The reconstruction is done with the help of an iterative algorithm. We show how the statistics of the illuminating beam can be incorporated into the reconstruction. The proposed reconstruction method can be considered as a useful alternative in the extreme cases where the standard ill-posed direct-inversion methods fail.Comment: 7 pages, 5 figure

Getting Under the Skin of Clinical Inertia in Insulin Initiation: The Translating Research Into Action for Diabetes (TRIAD) Insulin Starts Project

Purpose The purpose of this cross-sectional study is to explore primary care providers’ (PCPs) perceptions about barriers to initiating insulin among patients. Studies suggest that many patients with poorly controlled type 2 diabetes do not receive insulin initiation by PCPs. Methods As part of the Translating Research Into Action for Diabetes study, the authors conducted structured interviews in health systems in Indiana, New Jersey, and California, asking PCPs about the importance of insulin initiation and factors affecting this decision. The authors calculated proportions choosing each multiple-choice response option and listed the most frequently offered open-ended response categories. Results Among 83 PCPs, 45% were women; 60% were white; and they averaged 13.4 years in practice. Four-fifths of PCPs endorsed guideline-concordant glycemic targets, but 54% individualized targets based on patient age, life expectancy, medical comorbidities, self-management capacity, and willingness. Most (64%) reported that many patients were resistant to new oral or insulin therapies due to fears about the therapy and what it meant about their disease progression. Two-thirds (64%) cited patient resistance as a barrier to insulin initiation, and 43% cited problems with patient self-management, including cognitive or mental health issues, dexterity, or ability to adhere. Eighty percent felt that patient nonadherence would dissuade them from initiating insulin at least some of the time. Conclusions PCPs perceived that patient resistance and poor self- management skills were significant barriers to initiating insulin. Future studies should investigate whether systems-level interventions to improve patient-provider communication about insulin and enhance providers’ perceptions of patient self-management capacity can increase guideline-concordant, patient-centered insulin initiation

Association of smoking and nicotine dependence with pre-diabetes in young and healthy adults.

INTRODUCTION: Several studies have shown an increased risk of type 2 diabetes among smokers. Therefore, the aim of this analysis was to assess the relationship between smoking, cumulative smoking exposure and nicotine dependence with pre-diabetes. METHODS: We performed a cross-sectional analysis of healthy adults aged 25-41 in the Principality of Liechtenstein. Individuals with known diabetes, Body Mass Index (BMI) >35 kg/m² and prevalent cardiovascular disease were excluded. Smoking behaviour was assessed by self-report. Pre-diabetes was defined as glycosylated haemoglobin between 5.7% and 6.4%. Multivariable logistic regression models were done. RESULTS: Of the 2142 participants (median age 37 years), 499 (23.3%) had pre-diabetes. There were 1,168 (55%) never smokers, 503 (23%) past smokers and 471 (22%) current smokers, with a prevalence of pre-diabetes of 21.2%, 20.9% and 31.2%, respectively (p <0.0001). In multivariable regression models, current smokers had an odds ratio (OR) of pre-diabetes of 1.82 (95% confidential interval (CI) 1.39; 2.38, p <0.0001). Individuals with a smoking exposure of <5, 5-10 and >10 pack-years had an OR (95% CI) for pre-diabetes of 1.34 (0.90; 2.00), 1.80 (1.07; 3.01) and 2.51 (1.80; 3.59) (p linear trend <0.0001) compared with never smokers. A Fagerström score of 2, 3-5 and >5 among current smokers was associated with an OR (95% CI) for pre-diabetes of 1.27 (0.89; 1.82), 2.15 (1.48; 3.13) and 3.35 (1.73; 6.48) (p linear trend <0.0001). DISCUSSION: Smoking is strongly associated with pre-diabetes in young adults with a low burden of smoking exposure. Nicotine dependence could be a potential mechanism of this relationship

Comparison of optical probes and X-ray tomography for bubble characterization in fluidized bed methanation reactors

The performance of many fluidized bed reactors strongly depends on the bubble behavior since they influence the mass transfer to the dense phase where the catalyst is present. An example is the methanation in a fluidized bed that allows for conversion of unsaturated hydrocarbons in the gasification gas without catalyst deactivation [1]. The BFB reactor is a very challenging step in the process chain to produce SNG out of biomass as feedstock since next to the bubble behavior a lot of other parameters like temperature, pressure, particle size, attrition of the catalyst, internals, bed height and reactor diameter etc. affect the overall performance. The focus of this research work lies on the determination of the bubble properties which are an important factor to model a bubbling fluidized methanation reactor in order to predict and optimize its performance and to support its scale-up [2]. Tomographic methods such as X-ray measurements are often used to characterize bubbles in a fluidized bed. Compared to intrusive measurement, e.g. optical probing, this method possesses the advantage of measuring bubbles throughout the entire cross section. However, X-ray measurements cannot be applied to all installation, especially not in large scale plants. For these purpose, we have developed optical probes that can be employed to investigate the fluidization state in a hot pilot scale reactor. A main drawback of the optical measurements lies in their locally limited detection of the hydrodynamic pattern since they are only able to measure at one point in the reactor. Therefore, conclusions on the bubble behavior of the whole cross section based on optical measurements are not easy to derive. To compare the influence of the measurement method on the measured bubble properties, in the scope of this study, an artificial optical signal is created out of the existing X-ray measurement data set for a cold flow model of the pilot scale methanation reactor. The obtained bubble properties of both methods (i.e. evaluation of the derived artificial optical probe signal and image reconstruction based on the original X-ray tomographic data) are compared with regard to the hold-up, bubble rise velocity and the bubble size (for the X-ray method) or chord length (for the optical evaluation method), respectively. The process to obtain an artificial optical signal is depicted in Figure 1. The comparison shows that for the evaluation of optical probe data, statistical effects have to be considered carefully. The detected mean chord length of the optical method does not represent the mean bubble size determined by the X-ray method. Moreover, also a difference in the bubble rise velocity was detected for some fluidization states. This knowledge may be the basis for the derivation of a statistically sound method to calculate different hydrodynamic properties in fluidized bed reactors based on optical probe measurements. Please click Additional Files below to see the full abstract