Comparison of prostate cancer detection rates in patients undergoing MRI/TRUS fusion prostate biopsy with two different software-based systems.

BACKGROUND: Magnetic resonance imaging (MRI)-targeted prostate biopsy is a routinely used diagnostic tool for prostate cancer (PCa) detection. However, a clear superiority of the optimal approach for software-based MRI processing during biopsy procedures is still unanswered. To investigate the impact of robotic approach and software-based image processing (rigid vs. elastic) during MRI/transrectal ultrasound (TRUS) fusion prostate biopsy (FBx) on overall and clinically significant (cs) PCa detection. METHODS: The study relied on the instructional retrospective biopsy data collected data between September 2013 and August 2017. Overall, 241 men with at least one suspicious lesion (PI-RADS ≥ 3) on multiparametric MRI underwent FBx. The study protocol contains a systematic 12-core sextant biopsy plus 2 cores per targeted lesion. One experienced urologist performed 1048 targeted biopsy cores; 467 (45%) cores were obtained using rigid processing, while the remaining 581 (55%) cores relied on elastic image processing. CsPCa was defined as International Society of Urological Pathology (ISUP) grade ≥ 2. The effect of rigid versus elastic FBx on overall and csPCa detection rates was determined. Propensity score weighting and multivariable regression models were used to account for potential biases inherent to the retrospective study design. RESULTS: In multivariable regression analyses, age, prostate-specific antigen (PSA), and PIRADS ≥ 3 lesion were related to higher odds of finding csPCa. Elastic software-based image processing was independently associated with a higher overall PCa (odds ratio [OR] = 3.6 [2.2-6.1], p < 0.001) and csPCa (OR = 4.8 [2.6-8.8], p < 0.001) detection, respectively. CONCLUSIONS: Contrary to existing literature, our results suggest that the robotic-driven software registration with elastic fusion might have a substantial effect on PCa detection.

Anti urolithiatic activity of Cyperus rotundus tubers: In silico, In vitro and In vivo approaches

Abstract The present research evaluated the anti urolithic potential of Cyperus rotundus tubers extract using in silico, in vitro and in vivo techniques. In silicostudy was performed of Cyperus rotundus constituents and pathological protein oxalate oxidase (PDB Id: 2ETE). In vitrostudy, nucleation and aggregation assay involved for assessment of ethanol extract of Cyperus rotundus tuber (50-3000 µg/ml).In vivo studies involved that the Cyperus rotundusethanolic extract (100, 200 and 400 mg/kg B.wt.) wastreatedonsodium oxalate induced urolithiatic rats for seven days,evaluated kidney function by urine and serum biochemical analysis and statistical analysis performed usingGraphPad prism5 software.In silico results showedthat Cyperus rotundus constituents,Humulene epoxide, 4-Oxo-alpha-ylangene, Cubebol were exhibited better binding energyonoxalate oxidase.Ethanolic extract of Cyperus rotundustuber was exhibited nucleation, aggregation of calcium oxalate monohydrate crystals inhibition in dosedependent manner. Sodium oxalate treatment was triggered biochemical changesin the urine that have been substantially prevented by the ethanolic extract of Cyperus rotundus tuber. The current findings Cyperus rotundus anti urolithic activity due to antioxidant essential oils. The molecular docking results could be used to optimize lead and develop the appropriate urolithiasis treatment.

Research on Molecular Mechanism of Fructus Ligustri Lucidi against Osteoporosis based on Network Pharmacology

Abstract TCMSP platform of systematic pharmacology of traditional Chinese medicine This study aimed to investigate the molecular mechanism of Fructus Ligustri Lucidi (NZZ, Chinese abbreviation) against osteoporosis (OP) by means of network pharmacology.ChemDraw Professional 15.1 software and Molinspiration Smiles database were used to draw the chemical formulas of the components. The active ingredients and related target proteins of NZZ were searched in platform of systematic pharmacology of traditional Chinese medicine database, Drugbank, Therapeutic Target Database, SymMap and other databases. Gene Ontology(GO) enrichment and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis were carried out on the selected target through Enrichr and KEGG Automatic Annotation databases, and their mechanism was studied. A total of 29 compounds and 140 corresponding targets, including 14 key targets and 14 protein factors in protein-protein interaction core network were obtained. The key targets were tumor necrosis factor(TNF), interleukin(IL)-6R and sestrogen receptor alpha. The number of GO items was 466 (P<0.05), including 399 items of biological process (BP), 54 items of cell composition (MF) and 13 items of molecular function (CC). KEGG pathway enrichment screened 85 signaling pathways (P<0.05), including the IL-17 signaling pathway, TNF signaling pathway, advanced glycation end products and their receptors signaling pathway and cAMP signaling pathway. The active ingredients of NZZ. exert their anti-OP effects through multi-components, multi-targets and multi-pathways, which can provide new evidence for further study of their anti-OP mechanism.

Versión en español del software gratuito OxMaR para minimización y aleatorización de estudios clínicos / Spanish adaptation of the free OxMaR software for minimization and randomization of clinical studies

Los estudios clínicos aleatorizados aportan el más elevado nivel de evidencia científica. El método utilizado para la aleatorización debe hacer imprevisible el grupo al que será asignado cada caso, y facilitar la ocultación de la secuencia de aleatorización. Los métodos centralizados, generalmente con soporte informático, son considerados los más seguros para evitar la existencia de sesgos. El sistema OxMaR, acrónimo deOxford Minimization and Randomization, fue publicado comosoftwarede código abierto y gratuito en el año 2014. Funciona en línea, en entorno web, y permite realizar aleatorización simple y asignación adaptativa mediante minimización. Presentamos una versión en español desarrollada en colaboración con el autor de la versión original inglesa. El sistema ha sido modificado para trabajar en servidores web compartidos de bajo coste y para permitir la ocultación de la secuencia de aleatorización

Randomized clinical trials provide the highest level of scientific evidence. The method used for randomization should make the group to which each case will be assigned unpredictable and facilitate the concealment of the randomization sequence. Centralized methods, generally implemented with computer support, are considered the safest to avoid biases. The OxMaR system, acronym for Oxford Minimization and Randomization, was published as free and open source software in 2014. It works online in a web environment and allows simple randomization and adaptive assignment through minimization. We present a Spanish version developed in collaboration with the author of the original English version. The system has been modified to work on low cost shared web servers and also to allow the concealment of the randomization sequence

Familial DNA searching- an emerging forensic investigative tool.

In recent years, jurisdictions across the United States have expressed a growing interest in aiding criminal investigations through the use of familial DNA searching (FDS)- a forensic technique to identify family members through DNA databases. The National Survey of CODIS Laboratories surveyed U.S. CODIS laboratories about their perceptions, policies, and practices related to FDS. In total, 103 crime labs completed the survey (77% response rate). Labs in 11 states reported using FDS, while labs in 24 states reported using a similar-but distinct- practice of partial matching. Although the majority of labs had positive perceptions about the ability of FDS to assist investigations, labs also reported a number of concerns and challenges with implementing FDS. Respondents reported using either practice a limited amount with modest numbers of convictions resulting from both FDS and partial matching. The article reports on varying practices related to official policies, training, eligibility, the software search, lineage testing, requirements for releasing information, and subsequent investigative work. Finally, the article discusses what can be learned from this survey, accompanying limitations, and implications for decision-makers considering using FDS.

Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial.

OBJECTIVE: The aim of the MEDication reminder APPs to improve medication adherence in Coronary Heart Disease Study was to evaluate the effectiveness and feasibility of using publicly available high-quality medication reminder applications (apps) to improve medication adherence compared with usual care in patients with coronary heart disease (CHD). An additional aim was to examine whether an app with additional features improved adherence further. METHODS: Patients with CHD (n=163) were randomised to one of three groups: (1) usual care, (2) a basic app or (3) an advanced app with interactive/customisable features. The primary analysis compared usual care versus app use on the primary outcome of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 3 months. Secondary outcomes included blood pressure and cholesterol levels. RESULTS: The mean age was 57.9 years and 87.7% were male. At 3 months, patients using an app had higher adherence (mean MMAS-8 score 7.11) compared with the usual care group (mean MMAS-8 score 6.63) with a mean difference between groups of 0.47 (95% CI 0.12 to 0.82, p=0.008). There was no significant difference in patients using the basic app versus the advanced app (mean difference -0.16, 95% CI -0.56 to 0.24, p=0.428). There were no significant differences in secondary clinical outcome measures. CONCLUSION: Patients with CHD who used medication reminder apps had better medication adherence compared with usual care, and using apps with additional features did not improve this outcome further. These data suggest medication apps are likely to help patients with chronic health conditions adhere to medicines, but further examination of whether such benefits are sustained is warranted. CLINICAL TRIAL REGISTRATION NUMBER: ACTRN12616000661471; Results.

Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories. Final rule.

The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks.

In 2017, the U.S. Food and Drug Administration (FDA) announced a new program for software classified as a medical device. The Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development. Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised. In particular, Pre-Cert may reduce incentives for developers to study the safety and effectiveness of their software products before patients start to rely on them. Although postmarket surveillance can mitigate risks of these products, the FDA does not have as much authority after a product's widespread use to enforce data collection deadlines. Pre-Cert may also create confusion for patients and physicians, who may believe that marketed products were subject to rigorous study.

[Qualification and classification of medical apps : What should be noted and what is BfArM's contribution?] / Abgrenzung und Klassifizierung von Medical Apps : Was ist zu beachten und welche Unterstützung bietet das BfArM?

Smartphones and tablets with their nearly unlimited number of different applications have become an integral part of everyday life. Thus, mobile devices and applications have also found their way into the healthcare sector.For developers, manufacturers, or users as well, it is often difficult to decide whether a mobile health application is a medical device.In this context, it is extremely important for manufacturers to decide at an early stage of the development whether the product is to be introduced into the market as a medical device and is therefore subject to the legislation on medical devices.This article first presents the regulatory framework and subsequently introduces the reader to the Federal Institute for Drugs and Medical Devices' (BfArM) view of the criteria for differentiating between apps as non-medical products and apps as medical apps as well as the classification thereof. Various examples are presented to demonstrate how these criteria are applied practically and options that support developers and manufacturers in their decision making are shown. The article concludes with a reference to current developments and offers a perspective on the new European medical device regulations MDR/IVDR (Medical Device Regulation/In-Vitro Diagnostic Regulation) as well as on future challenges regarding medical apps.

Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Indirect Immunofluorescence Microscope and Software-Assisted System. Final order.

The Food and Drug Administration (FDA or we) is classifying the automated indirect immunofluorescence microscope and software-assisted system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated indirect immunofluorescence microscope and software-assisted system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The exploratory factor analysis of items: guided analysis based on empirical data and software / El análisis factorial exploratorio de los ítems: análisis guiado según los datos empíricos y el software

The aim of the present study is to illustrate how the appropriate or inappropriate application of exploratory factor analysis (EFA) can lead to quite different conclusions. To reach this goal, we evaluated the degree to which four different programs used to perform an EFA, specifically SPSS, FACTOR, PRELIS and MPlus, allow or limit the application of the currently recommended standards. In addition, we analyze and compare the results offered by the four programs when factor analyzing empirical data from scales that fit the assumptions of the classic linear EFA modeling adequately, ambiguously, or optimally, depending on the case, through the possibilities the different programs offer. The results of the comparison show the consequences of choosing one program or another; and the consequences of selecting some options or others within the same program, depending on the nature of the data. Finally, the study offers practical recommendations for applied researchers with a methodological orientation

El objetivo del presente trabajo es ilustrar cómo la aplicación adecuada o inadecuada del análisis factorial exploratorio (AFE) puede llevar a conclusiones muy diferentes. Para ello se evalúa el grado en que cuatro paquetes estadísticos diferentes que permiten realizar AFE de ítems, en concreto SPSS, FACTOR, PRELIS y MPlus, permiten o limitan la aplicación de los estándares actualmente recomendados en materia de análisis factorial. Asimismo se analizan y comparan los resultados que ofrecen dichos programas cuando se factorizan datos empíricos de escalas que ajustan, según el caso, de manera inadecuada, ambigua u óptima a los supuestos del modelo AFE lineal clásico, a través de las distintas posibilidades que ofrecen los distintos programas. Los resultados de la comparación ilustran las consecuencias de elegir entre un programa u otro, y también las consecuencias de elegir entre unas opciones u otras dentro de un mismo programa, en función de la naturaleza de los datos. Finalmente se ofrecen una serie de recomendaciones prácticas dirigidas a los investigadores aplicados con cierta orientación metodológica

Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for Psychiatric Disorders. Final order.

The Food and Drug Administration (FDA or we) is classifying the computerized behavioral therapy device for psychiatric disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the computerized behavioral therapy device for psychiatric disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid for Concussion. Final order.

The Food and Drug Administration (FDA) is classifying the Computerized Cognitive Assessment Aid for Concussion into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the computerized cognitive assessment aid for concussion's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

A multicenter study benchmarks software tools for label-free proteome quantification.

Consistent and accurate quantification of proteins by mass spectrometry (MS)-based proteomics depends on the performance of instruments, acquisition methods and data analysis software. In collaboration with the software developers, we evaluated OpenSWATH, SWATH 2.0, Skyline, Spectronaut and DIA-Umpire, five of the most widely used software methods for processing data from sequential window acquisition of all theoretical fragment-ion spectra (SWATH)-MS, which uses data-independent acquisition (DIA) for label-free protein quantification. We analyzed high-complexity test data sets from hybrid proteome samples of defined quantitative composition acquired on two different MS instruments using different SWATH isolation-window setups. For consistent evaluation, we developed LFQbench, an R package, to calculate metrics of precision and accuracy in label-free quantitative MS and report the identification performance, robustness and specificity of each software tool. Our reference data sets enabled developers to improve their software tools. After optimization, all tools provided highly convergent identification and reliable quantification performance, underscoring their robustness for label-free quantitative proteomics.

Certain aspects on medical devices software law regulation.

INTRODUCTION: some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. CONCLUSION: in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization ¼ for the medical device software approval process.

Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device. Final order.

The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the coronary vascular physiologic simulation software device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Volume Measurement of Various Tissues Using the Image J Software.

Various methods have been introduced to assess the tissue volume because volumetric evaluation is recognized as one of the most important steps in reconstructive surgery. Advanced volume measurement methods proposed recently use three-dimensional images. They are convenient but have drawbacks such as requiring expensive equipment and volume-analysis software. The authors devised a volume measurement method using the Image J software, which is in the public domain and does not require specific devices or software packages. The orbital and breast volumes were measured by our method using Image J data from facial computed tomography (CT) and breast magnetic resonance imaging (MRI). The authors obtained the final volume results, which were similar to the known volume values. The authors propose here a cost-effective, simple, and easily accessible volume measurement method using the Image J software.

Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid. Final order.

The Food and Drug Administration (FDA) is classifying the computerized cognitive assessment aid into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the computerized cognitive assessment aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Version changes in medical software: proposing minimal requirements for release notes and a version number convention - an operators' point of view.

Medical software--like any other software--is susceptible to errors. To avoid false system behaviour or attenuate its consequences, system operators need to know about changes in the software. The goal of this proposal is to define terms and minimum requirements regarding documentation for a version change from the operator's point of view, especially in the domain of medical software or software as a medical device (SaMD). The results are a classification of version changes (Upgrade: breaks support for a rollback to a prior version, Major Update: either substantial configuration or user education needed, Minor Update: minor configuration or user information needed, Patch: collection of (small) changes that require neither configuration nor user information.). Additionally, minimal requirements for release notes are determined and a document structure recommended.