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BackgroundThere is a lack of tools to evaluate and compare Electronic patient record (EPR) systems to inform a rational choice or development agenda. ObjectiveTo develop a tool kit to measure the impact of different EPR system features on the consultation. MethodsWe first developed a specification to overcome the limitations of existing methods. We divided this into work packages: (1) developing a method to display multichannel video of the consultation; (2) code and measure activities, including computer use and verbal interactions; (3) automate the capture of nonverbal interactions; (4) aggregate multiple observations into a single navigable output; and (5) produce an output interpretable by software developers. We piloted this method by filming live consultations (n = 22) by 4 general practitioners (GPs) using different EPR systems. We compared the time taken and variations during coded data entry, prescribing, and blood pressure (BP) recording. We used nonparametric tests to make statistical comparisons. We contrasted methods of BP recording using Unified Modeling Language (UML) sequence diagrams. ResultsWe found that 4 channels of video were optimal. We identified an existing application for manual coding of video output. We developed in-house tools for capturing use of keyboard and mouse and to time stamp speech. The transcript is then typed within this time stamp. Although we managed to capture body language using pattern recognition software, we were unable to use this data quantitatively. We loaded these observational outputs into our aggregation tool, which allows simultaneous navigation and viewing of multiple files. This also creates a single exportable file in XML format, which we used to develop UML sequence diagrams. In our pilot, the GP using the EMIS LV (Egton Medical Information Systems Limited, Leeds, UK) system took the longest time to code data (mean 11.5 s, 95% CI 8.7-14.2). Nonparametric comparison of EMIS LV with the other systems showed a significant difference, with EMIS PCS (Egton Medical Information Systems Limited, Leeds, UK) (P = .007), iSoft Synergy (iSOFT, Banbury, UK) (P = .014), and INPS Vision (INPS, London, UK) (P = .006) facilitating faster coding. In contrast, prescribing was fastest with EMIS LV (mean 23.7 s, 95% CI 20.5-26.8), but nonparametric comparison showed no statistically significant difference. UML sequence diagrams showed that the simplest BP recording interface was not the easiest to use, as users spent longer navigating or looking up previous blood pressures separately. Complex interfaces with free-text boxes left clinicians unsure of what to add. ConclusionsThe ALFA method allows the precise observation of the clinical consultation. It enables rigorous comparison of core elements of EPR systems. Pilot data suggests its capacity to demonstrate differences between systems. Its outputs could provide the evidence base for making more objective choices between systems.

In May 2022, there is an International Regulatory and Pharmaceutical Industry (Innovation and Quality [IQ] Microphysiological Systems [MPS] Affiliate) Workshop on the standardization of complex in vitro models (CIVMs) in drug development. This manuscript summarizes the discussions and conclusions of this joint workshop organized and executed by the IQ MPS Affiliate and the United States Food and Drug Administration (FDA). A key objective of the workshop is to facilitate discussions around opportunities and/or needs for standardization of MPS and chart potential pathways to increase model utilization in the context of regulatory decision making. Participation in the workshop included 200 attendees from the FDA, IQ MPS Affiliate, and 26 global regulatory organizations and affiliated parties representing Europe, Japan, and Canada. It is agreed that understanding global perspectives regarding the readiness of CIVM/MPS models for regulatory decision making and potential pathways to gaining acceptance is useful to align on globally. The obstacles are currently too great to develop standards for every context of use (COU). Instead, it is suggested that a more tractable approach may be to think of broadly applicable standards that can be applied regardless of COU and/or organ system. Considerations and next steps for this effort are described. [ABSTRACT FROM AUTHOR]

Microphysiological systems (MPS) are gaining broader application in the pharmaceutical industry but have primarily been leveraged in early discovery toxicology and pharmacology studies with small molecules. The adoption of MPS offers a promising avenue to reduce animal use, improve in-vitro-to-in-vivo translation of pharmacokinetics/pharmacodynamics and toxicity correlation, and provide mechanistic understanding of model species suitability. While MPS have demonstrated utility in these areas with small molecules and biologics, MPS models in cell therapy development have not been fully explored, let alone validated. Distinguishing features of MPS, including longterm viability and physiologically relevant expression of functional enzymes, receptors, and pharmacological targets make them attractive tools for nonclinical characterization. However, there is currently limited published evidence of MPS being utilized to study the disposition, metabolism, pharmacology, and toxicity profiles of cell therapies. This review provides an industry perspective on the nonclinical application of MPS on cell therapies, first with a focus on oncology applications followed by examples in regenerative medicine. [ABSTRACT FROM AUTHOR]

Background: Connections between long‐term use of topical corticosteroids (TCSs) of varying potency and osteoporosis and major osteoporotic fracture (MOF) are unclear. Susceptibility to adverse bone effects of TCSs in different sex, age and ethnic groups is unknown too. Objectives: To demonstrate the association between cumulative dose of TCSs of varying potency and osteoporosis and MOF in Taiwanese population, with stratified analysis of sex and age. Methods: We conducted a nationwide case–control study and obtained data from Taiwan National Health Insurance Research Database. Cumulative TCS doses in different exposure periods were calculated, and the potency of TCSs was converted to prednisolone equivalent. Adjusted odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for osteoporosis and MOF associated with TCS use. Results: From 2017 to 2020, 129,682 osteoporosis cases and 34,999 MOF cases were selected and randomly matched with 518,728 and 139,996 controls by sex and age. We found clear dose–response relationships between long‐term TCS exposure and osteoporosis and MOF. For example, compared to no TCS use, adjusted ORs of osteoporosis were 1.216 (95% CI 1.189–1.243), 1.260 (95% CI, 1.241–1.280) and 1.341 (95% CI, 1.314–1.369) for exposure to low, medium and high cumulative TCS doses, respectively, over 5 years. Adjusted ORs of MOF were 1.118 (95% CI 1.069–1.170), 1.191 (95% CI, 1.156–1.227) and 1.288 (95% CI, 1.238–1.340) for exposure to low, medium and high cumulative TCS doses, respectively, over 5 years. Stratified analysis showed women had higher ORs of osteoporosis and MOF compared to men. Younger people (<50 years) had highest OR of osteoporosis compared to other age groups. Conclusions: Higher cumulative TCS dose was associated with increased risk of osteoporosis and MOF. Long‐term use of TCSs should be cautious, especially in susceptible populations such as women and young people. [ABSTRACT FROM AUTHOR]

Indoor positioning system (IPS) technologies have widespread applications in logistics, intelligent manufacturing, healthcare monitoring, etc. The recently released Bluetooth low‐energy (BLE) 5.1 specification enables in‐phase and quadrature‐phase (I/Q) data measurements. It allows angle of arrival estimation and becomes a natural choice for IPS implementation. Conventional BLE 5.1 IPSs use multiple anchors to provide massive redundancy to improve system robustness. It however demands effective approaches to leverage redundancy. Besides, interference due to various environmental factors can introduce severe errors to I/Q data and affect positioning accuracy. Facing these challenges, herein, a novel deep learning‐based multianchor BLE 5.1 IPS is proposed. The system aggregates measurements from multiple anchors and makes them available at regular time steps. Then, a novel attentional filtering network tailored to infer high‐quality I/Q sample data is developed and a spatial regularization loss incorporating spatial location relationships to strengthen the feature embedding discrimination is proposed. Two multianchor BLE 5.1 I/Q sample datasets are developed and released for public download. Numerical experiments are carried out to compare the proposed method with previous BLE 5.1 IPS methods and methods utilizing other radio frequency data. Results indicate that the proposed method consistently achieves submeter accuracy and significantly outperforms the state‐of‐the‐art approaches. [ABSTRACT FROM AUTHOR]

To increase the reliability of the printed circuit board (PCB) manufacturing process, automated optical inspection is often employed for soldering defect detection. However, traditional approaches built on handcrafted features, predefined rules, or thresholds are often susceptible to the variation of the acquired images' quality and give unstable performances. To solve this problem, a deep learning‐based soldering defect detection method is developed in this article. Like many real‐life deep learning applications, the number of available training samples is often limited. This creates a challenging low‐data scenario, as deep learning typically requires massive data to perform well. To address this issue, a multitask learning model is proposed, namely, PCBMTL, that can simultaneously learn the classification and segmentation tasks under low‐data regimes. By acquiring the segmentation knowledge, classification performance is substantially improved with few samples. To facilitate the study, a soldering defect image dataset, namely, PCBSPDefect, is built. It focuses on the dual in‐line packages (DIP) at the PCB back side, DIP at the PCB front side, and flat flexible cables. Experimental results show that the proposed PCBMTL outperforms the best existing approaches by over 5–17% of average accuracy for different datasets. [ABSTRACT FROM AUTHOR]

Investigates the effect of activity content, its presentation, and the interactions between the two on flow experience (intrinsic motivation) in instructional activity. Results suggest that activity content has major influences on motivation; hypermedia presentations can add to motivation if used appropriately, or they can be distracting if too complex. Three tables show data. (AEF)