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Food and Drug Administration’s (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge–attitudes–behaviors (KAB) surveys as regulatory science tools. This mixed-methods evaluation advances regulatory science and the assessment of FDA REMS programs when using physician surveys. We: (1) reviewed published physician survey response rates; and (2) assessed response bias in a simulation study of secondary survey data using different accrual cut-off strategies.
A systematic literature review was conducted of US physician surveys (2000–2014) on pharmaceutical use (n = 75). Kruskal–Wallis tests were used to examine the relationships between response rates and survey design characteristics. The simulation was conducted using secondary data from a population-based physician KAB survey on diabetes risk management with antipsychotic use in Missouri Medicaid (n = 973 accrued over 30 weeks). Survey item responses were compared using Pearson’s chi-square tests for two faster completion simulations: Fixed Sample (n = 300) and Fixed Time (8 weeks).
Survey response rates ranged from 7% to 100% (median = 48%, IQR = 34%–68%). Surveys of targeted populations and surveys using member lists were associated with higher response rates (p = 0.02). In the simulation, 9 of 20 (45%) KAB items, including diabetes screening advocacy, differed significantly using the smaller Fixed Sample strategy (achieved in 12 days) versus full accrual. Fewer response differences were found using the Fixed Time strategy (2 of 20 [10%] items).
Published data on physician surveys report low response rates with most associated with the sample source selected. FDA REMS assessments should include formal evaluation of survey accrual and response bias.
Residual stress values in a material are governed by the measurements of the atomic spacings in a specific crystallographic plane and the elastic constant for that plane. It has been reported that the value of the elastic constant depends on microstructure, preferred orientation, plastic deformation and morphology , Thus, the theoretical calculation of the elastic constant may deviate from the intrinsic value for a real alloy.
Community-based screening for mental health problems may increase service
use through feedback to individuals about their severity of symptoms and
provision of contacts for appropriate services.
The effect of symptom feedback on service use was assessed. Secondary
outcomes included symptom change and study attrition.
Using online recruitment, 2773 participants completed a comprehensive
survey including screening for depression (n=1366) or
social anxiety (n=1407). Across these two versions,
approximately half (n=1342) of the participants were
then randomly allocated to receive tailored feedback. Participants were
reassessed after 3 months (Australian New Zealand Clinical Trials
A negative effect of providing social anxiety feedback to individuals was
observed, with significant reductions in professional service use.
Greater attrition and lower intentions to seek help were also observed
Online mental health screening with feedback is not effective for
promoting professional service use. Alternative models of online
screening require further investigation.
The Yale–Potsdam Stellar Isochrones (YaPSI) cover the low and intermediate stellar mass regime (0.15 to 5.0 M⊙) for a wide range of solar-scaled chemical compositions (metallicity from −0.5 to +0.3; helium mass fraction from 0.25 to 0.37, assigned independently of each other). The tracks are finely spaced in mass, to allow for accurate interpolation. The models feature state-of-the-art input physics relevant to low-mass stars modeling (surface boundary conditions, equation of state), thus updating the faint end of the Yonsei-Yale (YY) isochrones. Utility codes, such as an isochrone interpolator in age, metallicity and helium content, are also provided. The YaPSI isochrones are in good agreement with the empirical mass–luminosity and mass–radius relations available to date, and provide satisfactory fitting of the color-magnitude diagrams of well-studied open clusters.
Cognitive deficits are a core feature of schizophrenia, and impairments in most domains are thought to be stable over the course of the illness. However, cross-sectional evidence indicates that some areas of cognition, such as visuospatial associative memory, may be preserved in the early stages of psychosis, but become impaired in later established illness stages. This longitudinal study investigated change in visuospatial and verbal associative memory following psychosis onset.
In total 95 first-episode psychosis (FEP) patients and 63 healthy controls (HC) were assessed on neuropsychological tests at baseline, with 38 FEP and 22 HCs returning for follow-up assessment at 5–11 years. Visuospatial associative memory was assessed using the Cambridge Neuropsychological Test Automated Battery Visuospatial Paired-Associate Learning task, and verbal associative memory was assessed using Verbal Paired Associates subtest of the Wechsler Memory Scale - Revised.
Visuospatial and verbal associative memory at baseline did not differ significantly between FEP patients and HCs. However, over follow-up, visuospatial associative memory deteriorated significantly for the FEP group, relative to healthy individuals. Conversely, verbal associative memory improved to a similar degree observed in HCs. In the FEP cohort, visuospatial (but not verbal) associative memory ability at baseline was associated with functional outcome at follow-up.
Areas of cognition that develop prior to psychosis onset, such as visuospatial and verbal associative memory, may be preserved early in the illness. Later deterioration in visuospatial memory ability may relate to progressive structural and functional brain abnormalities that occurs following psychosis onset.
We compared the cost-effectiveness (CE) of an active case-finding (ACF) programme for household contacts of tuberculosis (TB) cases enrolled in first-line treatment to routine passive case-finding (PCF) within an established national TB programme in Peru. Decision analysis was used to model detection of TB in household contacts through: (1) self-report of symptomatic cases for evaluation (PCF), (2) a provider-initiated ACF programme, (3) addition of an Xpert MTB/RIF diagnostic test for a single sputum sample from household contacts, and (4) all strategies combined. CE was calculated as the incremental cost-effectiveness ratio (ICER) in terms of US dollars per disability-adjusted life years (DALYs) averted. Compared to PCF alone, ACF for household contacts resulted in an ICER of $2155 per DALY averted. The addition of the Xpert MTB/RIF diagnostic test resulted in an ICER of $3275 per DALY averted within a PCF programme and $3399 per DALY averted when an ACF programme was included. Provider-initiated ACF of household contacts in an urban setting of Lima, Peru can be highly cost-effective, even including costs to seek out contacts and perform an Xpert/MTB RIF test. ACF including Xpert MTB/RIF was not cost-effective if TB cases detected had high rates of default from treatment or poor outcomes.
There has been an explosion of interest in mindfulness-based programs (MBPs) such as Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy. This is demonstrated in increased research, implementation of MBPs in healthcare, educational, criminal justice and workplace settings, and in mainstream interest. For the sustainable development of the field there is a need to articulate a definition of what an MBP is and what it is not. This paper provides a framework to define the essential characteristics of the family of MBPs originating from the parent program MBSR, and the processes which inform adaptations of MBPs for different populations or contexts. The framework addresses the essential characteristics of the program and of teacher. MBPs: are informed by theories and practices that draw from a confluence of contemplative traditions, science, and the major disciplines of medicine, psychology and education; underpinned by a model of human experience which addresses the causes of human distress and the pathways to relieving it; develop a new relationship with experience characterized by present moment focus, decentering and an approach orientation; catalyze the development of qualities such as joy, compassion, wisdom, equanimity and greater attentional, emotional and behavioral self-regulation, and engage participants in a sustained intensive training in mindfulness meditation practice, in an experiential inquiry-based learning process and in exercises to develop understanding. The paper's aim is to support clarity, which will in turn support the systematic development of MBP research, and the integrity of the field during the process of implementation in the mainstream.
The enhancement of photovoltaic efficiency by incorporation of down-shifting phosphor materials in optically active and inactive regions of solar modules is presented. Thin film photovoltaic modules suffer from various optical losses, including front glass reflectance, thermalization loss of absorbed high energy photons, window layer absorption, and the loss of photons to scribe regions. There have been various efforts to improve the performance of solar modules by application of down-shifting (DS), down-converting, and up-converting materials systems. Here we show results towards the development of a low-cost phosphor film system tuned to the solar spectrum and specifically designed for CdTe thin film modules.
Published between 1862 and 1932, and reissued here in multiple parts, this monumental calendar of documents remains an essential starting point for the serious study of Tudor history. An experienced editor of historical texts, John Sherren Brewer (1809–79) had no prior training in the history of the period, yet he brought to the project the necessary industriousness and an impeccable command of Latin. Four volumes appeared before his death, whereupon James Gairdner (1828–1912), his former assistant, took up the editorial reins. Continuing Brewer's method of ordering chronologically all available documents from 1509 to 1547, and reproducing some passages while paraphrasing or omitting others, Gairdner brought the project to its conclusion, aided himself by R. H. Brodie (1859–1943) in preparing the later volumes. Volume 1 (1862) has been split into two for this reissue: this first half covers the period from April 1509 to May 1513.