A methodological proposal and tool support for the HL7 standards compliance in the development of health information systems

Health information systems are increasingly complex, and their development is presented as a challenge for software development companies offering quality, maintainable and interoperable products. HL7 (Health level 7) International, an international non-profit organization, defines and maintains standards related to health information systems. However, the modelling languages proposed by HL7 are far removed from standard languages and widely known by software engineers. In these lines, NDT is a software development methodology that has a support tool called NDT-Suite and is based, on the one hand, on the paradigm of model-driven engineering and, on the other hand, in UML that is a widely recognized standard language. This paper proposes an extension of the NDT methodology called MoDHE (Model Driven Health Engineering) to offer software engineers a methodology capable of modelling health information systems conforming to HL7 using UML domain models

A Framework to Evaluate Software Developer’s Productivity The VALORTIA Project

Currently, there is a lack in companies developing software in relation to assessing their staff’s productivity before executing software projects, with the aim of improving effectiveness and efficiency. QuEF (Quality Evaluation Framework) is a framework that allows defining quality management tasks based on a model. The main purpose of this framework is twofold: improve an entity’s continuous quality, and given a context, decide between a set of entity’s instances on the most appropriate one. Thus, the aim of this paper is to make this framework available to evaluate productivity of professionals along software development and select the most appropriate experts to implement the suggested project. For this goal, Valortia platform, capable of carrying out this task by following the QuEF framework guidelines, is designed. Valortia is a platform to certify users' knowledge on a specific area and centralize all certification management in its model by means of providing protocols and methods for a suitable management, improving efficiency and effectiveness, reducing cost and ensuring continuous quality.Ministerio de Ciencia e Innovación TIN2013-46928-C3-3-

Formación de Máster en Protección Radiológica en Instalaciones Radiactivas y Nucleares

En este trabajo, se presenta la impartición de un Máster en Protección Radiológica en Instalaciones Radiactivas y Nucleares cuya dirección se lleva desde la Universidad Politécnica de Valencia en coordinación con la empresa Titania Servicios Tecnológicos, spin-off de dicha universidad. La impartición se realiza de forma semipresencial y abarca los conocimientos y habilidades de funciones relativas a Jefe de Servicio de Protección Radiológica. Los contenidos son los relacionados con aspectos generales y específicos necesarios para desarrollar las tareas de protección radiológica en distintos campos de aplicación: Instalaciones Radiactivas (Industriales, Médicas: Medicina Nuclear, Radioterapia y Radiodiagnóstico, y de Investigación) e Instalaciones Nucleares. El máster contempla un módulo avanzado para adquirir una formación de mayor nivel en aspectos destacados como desmantelamiento de instalaciones nucleares, cálculo de blindajes mediante códigos avanzados, aceleradores de partículas, normativa internacional, etc. La impartición del curso cuenta con una parte online mediante la plataforma tecnológica Poliformat de la Universidad Politécnica de Valencia, a través de lecciones guiadas, ejercicios prácticos, autoevaluaciones y tutorías online para facilitar el aprendizaje. El curso se complementa con un parte presencial que consiste en diversas prácticas en instalaciones industriales, sanitarias, nucleares etc. seminario y examen presencial, para chequear los conocimientos adquiridos. La formación online permite una formación diseñada a medida, con una mayor flexibilidad y comodidad. En el campo de la protección radiológica y seguridad nuclear, las entidades dedicadas a labores de mantenimiento y asesoramiento, suelen tener a sus trabajadores desplazados en distintas instalaciones nucleares y radiactivas. Cuando surge una necesidad formativa, les resulta interesante el poder acceder a este tipo de formación para poder compaginarla con su trabajo diario de forma más eficaz. De este modo el máster incorpora herramientas que permiten adaptar una formación demandada en la actualidad más adaptada y realizar un seguimiento del curso de manera eficiente.Verdú Martín, GJ.; Mayo Nogueira, P.; Campayo, J. (2011). Formación de Máster en Protección Radiológica en Instalaciones Radiactivas y Nucleares. Sociedad Nuclear Española. http://hdl.handle.net/10251/71502

Infection with chikungunya virus confers heterotypic cross-neutralizing antibodies and memory B-cells against other arthritogenic alphaviruses predominantly through the B domain of the E2 glycoprotein

Infections with Chikungunya virus, a mosquito-borne alphavirus, cause an acute febrile syndrome often followed by chronic arthritis that persists for months to years post-infection. Neutralizing antibodies are the primary immune correlate of protection elicited by infection, and the major goal of vaccinations in development. Using convalescent blood samples collected from both endemic and non-endemic human subjects at multiple timepoints following suspected or confirmed chikungunya infection, we identified antibodies with broad neutralizing properties against other alphaviruses within the Semliki Forest complex. Cross-neutralization generally did not extend to the Venezuelan Equine Encephalitis virus (VEEV) complex, although some subjects had low levels of VEEV-neutralizing antibodies. This suggests that broadly neutralizing antibodies elicited following natural infection are largely complex restricted. In addition to serology, we also performed memory B-cell analysis, finding chikungunya-specific memory B-cells in all subjects in this study as remotely as 24 years post-infection. We functionally assessed the ability of memory B-cell derived antibodies to bind to chikungunya virus, and related Mayaro virus, as well as the highly conserved B domain of the E2 glycoprotein thought to contribute to cross-reactivity between related Old-World alphaviruses. To specifically assess the role of the E2 B domain in cross-neutralization, we depleted Mayaro and Chikungunya virus E2 B domain specific antibodies from convalescent sera, finding E2B depletion significantly decreases Mayaro virus specific cross-neutralizing antibody titers with no significant effect on chikungunya virus neutralization, indicating that the E2 B domain is a key target of cross-neutralizing and potentially cross-protective neutralizing antibodies

An Integrated TCGA Pan-Cancer Clinical Data Resource to Drive High-Quality Survival Outcome Analytics

For a decade, The Cancer Genome Atlas (TCGA) program collected clinicopathologic annotation data along with multi-platform molecular profiles of more than 11,000 human tumors across 33 different cancer types. TCGA clinical data contain key features representing the democratized nature of the data collection process. To ensure proper use of this large clinical dataset associated with genomic features, we developed a standardized dataset named the TCGA Pan-Cancer Clinical Data Resource (TCGA-CDR), which includes four major clinical outcome endpoints. In addition to detailing major challenges and statistical limitations encountered during the effort of integrating the acquired clinical data, we present a summary that includes endpoint usage recommendations for each cancer type. These TCGA-CDR findings appear to be consistent with cancer genomics studies independent of the TCGA effort and provide opportunities for investigating cancer biology using clinical correlates at an unprecedented scale. Analysis of clinicopathologic annotations for over 11,000 cancer patients in the TCGA program leads to the generation of TCGA Clinical Data Resource, which provides recommendations of clinical outcome endpoint usage for 33 cancer types

Site of struggle: the Freedom Park fracas and the divisive legacy of South Africa’s Border War/Liberation Struggle

In South Africa, Carcharias taurus is commonly known as the ragged-tooth shark or raggie. The species is also referred to as the sand-tiger shark in North America and as the grey-nurse shark in Australia. It is a long-lived species with an estimated longevity of up to 40 years (Goldman 2002). Female sharks reach sexual maturity at approximately 10 years (Goldman 2002), and they exhibit a biennial reproductive cycle (Branstetter and Musick 1994, Lucifora et al. 2002, G Cliff, Natal Sharks Board, unpublished data). Intra-uterine cannibalisation results in a maximum fecundity of two pups per litter after a gestation period of approximately 9–12 months (Bass et al. 1975, Gilmore et al. 1983). These life-history characteristics make this species particularly susceptible to overexploitation

Role of age and comorbidities in mortality of patients with infective endocarditis

Purpose: The aim of this study was to analyse the characteristics of patients with IE in three groups of age and to assess the ability of age and the Charlson Comorbidity Index (CCI) to predict mortality. Methods: Prospective cohort study of all patients with IE included in the GAMES Spanish database between 2008 and 2015. Patients were stratified into three age groups:<65 years, 65 to 80 years, and = 80 years.The area under the receiver-operating characteristic (AUROC) curve was calculated to quantify the diagnostic accuracy of the CCI to predict mortality risk. Results: A total of 3120 patients with IE (1327 < 65 years;1291 65-80 years;502 = 80 years) were enrolled.Fever and heart failure were the most common presentations of IE, with no differences among age groups.Patients =80 years who underwent surgery were significantly lower compared with other age groups (14.3%, 65 years; 20.5%, 65-79 years; 31.3%, =80 years). In-hospital mortality was lower in the <65-year group (20.3%, <65 years;30.1%, 65-79 years;34.7%, =80 years;p < 0.001) as well as 1-year mortality (3.2%, <65 years; 5.5%, 65-80 years;7.6%, =80 years; p = 0.003).Independent predictors of mortality were age = 80 years (hazard ratio [HR]:2.78;95% confidence interval [CI]:2.32–3.34), CCI = 3 (HR:1.62; 95% CI:1.39–1.88), and non-performed surgery (HR:1.64;95% CI:11.16–1.58).When the three age groups were compared, the AUROC curve for CCI was significantly larger for patients aged <65 years(p < 0.001) for both in-hospital and 1-year mortality. Conclusion: There were no differences in the clinical presentation of IE between the groups. Age = 80 years, high comorbidity (measured by CCI), and non-performance of surgery were independent predictors of mortality in patients with IE.CCI could help to identify those patients with IE and surgical indication who present a lower risk of in-hospital and 1-year mortality after surgery, especially in the <65-year group

Production of a non-stoichiometric Nb-Ti HSLA steel by thermomechanical processing on a steckel mill

Obtaining high levels of mechanical properties in steels is directly linked to the use of special mechanical forming processes and the addition of alloying elements during their manufacture. This work presents a study of a hot-rolled steel strip produced to achieve a yield strength above 600 MPa, using a niobium microalloyed HSLA steel with non-stoichiometric titanium (titanium/nitrogen ratio above 3.42), and rolled on a Steckel mill. A major challenge imposed by rolling on a Steckel mill is that the process is reversible, resulting in long interpass times, which facilitates recrystallization and grain growth kinetics. Rolling parameters whose aim was to obtain the maximum degree of microstructural refinement were determined by considering microstructural evolution simulations performed in MicroSim-SM (R) software and studying the alloy through physical simulations to obtain critical temperatures and determine the CCT diagram. Four ranges of coiling temperatures (525-550 degrees C/550-600 degrees C/600-650 degrees C/650-700 degrees C) were applied to evaluate their impact on microstructure, precipitation hardening, and mechanical properties, with the results showing a very refined microstructure, with the highest yield strength observed at coiling temperatures of 600-650 degrees C. This scenario is explained by the maximum precipitation of titanium carbide observed at this temperature, leading to a greater contribution of precipitation hardening provided by the presence of a large volume of small-sized precipitates. This paper shows that the combination of optimized industrial parameters based on metallurgical mechanisms and advanced modeling techniques opens up new possibilities for a robust production of high-strength steels using a Steckel mill. The microstructural base for a stable production of high-strength hot-rolled products relies on a consistent grain size refinement provided mainly by the effect of Nb together with appropriate rolling parameters, and the fine precipitation of TiC during cooling provides the additional increase to reach the requested yield strength values

Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension

Importance: Clinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis. Objective: To develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports. Findings: The scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18). Conclusions and Relevance: This CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results

Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension

Importance: Complete information in a trial protocol regarding study outcomes is crucial for obtaining regulatory approvals, ensuring standardized trial conduct, reducing research waste, and providing transparency of methods to facilitate trial replication, critical appraisal, accurate reporting and interpretation of trial results, and knowledge synthesis. However, recommendations on what outcome-specific information should be included are diverse and inconsistent. To improve reporting practices promoting transparent and reproducible outcome selection, assessment, and analysis, a need for specific and harmonized guidance as to what outcome-specific information should be addressed in clinical trial protocols exists. Objective: To develop harmonized, evidence- and consensus-based standards for describing outcomes in clinical trial protocols through integration with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. Evidence Review: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for outcome-specific reporting to be addressed in clinical trial protocols. Findings: The scoping review and consultation with experts identified 108 recommendations relevant to outcome-specific reporting to be addressed in trial protocols, the majority (72%) of which were not included in the SPIRIT 2013 statement. All recommendations were consolidated into 56 items for Delphi voting; after the Delphi survey process, 19 items met criteria for further evaluation at the consensus meeting and possible inclusion in the SPIRIT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 9 items that elaborate on the SPIRIT 2013 statement checklist items and are related to completely defining and justifying the choice of primary, secondary, and other outcomes (SPIRIT 2013 statement checklist item 12) prospectively in the trial protocol, defining and justifying the target difference between treatment groups for the primary outcome used in the sample size calculations (SPIRIT 2013 statement checklist item 14), describing the responsiveness of the study instruments used to assess the outcome and providing details on the outcome assessors (SPIRIT 2013 statement checklist item 18a), and describing any planned methods to account for multiplicity relating to the analyses or interpretation of the results (SPIRIT 2013 statement checklist item 20a). Conclusions and Relevance: This SPIRIT-Outcomes 2022 extension of the SPIRIT 2013 statement provides 9 outcome-specific items that should be addressed in all trial protocols and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results