Open source code for the generation of digital reference objects for dynamic contrast-enhanced MRI analysis software validation.

OBJECTIVES: Dynamic contrast-enhanced MR images can be analyzed through the application of a wide range of kinetic models. This process is prone to variability and a lack of standardization that can affect the measured metrics. There is a need for customized digital reference objects (DROs) for the validation of DCE-MRI software packages that undertake kinetic model analysis. DROs are currently available only for a small subset of the kinetic models commonly applied to DCE-MRI data. This work aimed to address this gap. METHODS: Code was written in the MATLAB programming environment to generate customizable DROs. This modular code allows the insertion of a plug-in to describe the kinetic model to be tested. We input our generated DROs into three commercial and open-source analysis packages and assessed the agreement of kinetic model parameter values output with the 'ground-truth' values used in the DRO generation. RESULTS: For the five kinetic models tested, the concordance correlation coefficient values were >98%, indicating excellent agreement of the results with 'ground-truth'. CONCLUSIONS: Testing our DROs on three independent software packages produced concordant results, strongly suggesting our DRO generation code is correct. This implies that our DROs can be used to validate other third party software for the kinetic model analysis of DCE-MRI data. ADVANCES IN KNOWLEDGE: This work extends published work of others to allow customized generation of test objects for any applied kinetic model and allows the incorporation of B1 mapping into the DRO for application at higher field strengths.

Ultrasound Calculation of Fat Volume for Liposuction: A Clinical Software Validation.

BACKGROUND: Fat manipulation procedures such as liposuction contain a degree of subjectivity primarily guided by the surgeon's visual or tactile perception of the underlying fat. Currently, there is no cost-effective, direct method to objectively measure fat depth and volume in real time. OBJECTIVES: Utilizing innovative ultrasound-based software, the authors aimed to validate fat tissue volume and distribution measurements in the preoperative setting. METHODS: Eighteen participants were recruited to evaluate the accuracy of the new software. Recruited participants underwent ultrasound scans within the preoperative markings of the study area before surgery. Ultrasound-estimated fat profiles were generated with the in-house software and compared directly with the intraoperative aspirated fat recorded after gravity separation. RESULTS: Participants' mean age and BMI were 47.6 (11.3) years and 25.6 (2.3) kg/m2, respectively. Evaluation of trial data showed promising results following the use of a Bland Altman agreement analysis. For the 18 patients and 44 volumes estimated, 43 of 44 measurements fell within a confidence interval of 95% when compared with the clinical lipoaspirate (dry) volumes collected postsurgery. The bias was estimated at 9.15 mL with a standard deviation of 17.08 mL and 95% confidence interval between -24.34 mL and 42.63 mL. CONCLUSIONS: Preoperative fat assessment measurements agreed significantly with intraoperative lipoaspirate volumes. The pilot study demonstrates, for the first time, a novel companion tool with the prospect of supporting surgeons in surgical planning, measuring, and executing the transfer of adipose tissues.

Detecting atrial fibrillation in the polysomnography-derived electrocardiogram: a software validation study.

PURPOSE: The present study validated a software-based electrocardiogram (ECG) analysis tool for detection of atrial fibrillation (AF) and risk for AF using polysomnography (PSG)-derived ECG recordings. METHODS: The Stroke Risk Analysis® (SRA®) software was applied to 3-channel ECG tracings from diagnostic PSG performed in enrolled subjects including a subgroup of subjects with previously documented AF. No subjects used positive airway pressure therapy. All ECG recordings were visually analyzed by a blinded cardiologist. RESULTS: Of subjects enrolled in the study, 93 had previously documented AF and 178 of 186 had an ECG that could be analyzed by either method. In subjects with known history of AF, automated analysis using SRA® classified 47 out of 87 ECG as either manifest AF or showing increased risk for paroxysmal AF (PAF) by SRA® (sensitivity 0.54, specificity 0.86). On visual analysis, 36/87 ECG showed manifest AF and 51/87 showed sinus rhythm. Among the latter subgroup, an increased risk for PAF was ascribed by SRA® in 11 cases (sensitivity 0.22, specificity 0.78) and by expert visual analysis in 5 cases (sensitivity 0.1, specificity 0.90). Among 36/178 ECG with manifest AF on visual analysis, 33 were correctly identified by the SRA® software (sensitivity and specificity 0.92). CONCLUSION: Sleep studies provide a valuable source of ECG recordings that can be easily subjected to software-based analysis in order to identify manifest AF and automatically assess the risk of PAF. For optimal evaluability of data, multiple channel ECG tracings are desirable. For assessment of PAF risk, the SRA® analysis probably excels visual analysis, but sensitivity of both methods is low, reflecting that repeated ECG recording remains essential.

Desenvolvimento e implementação de sistema de gerenciamento de cirurgias voltado a um hospital universitário / Development and implementation of a surgery management system aimed at a university hospital / Desarrollo e implementación de um sistema de gestión de cirugías dirigido a un hospital universitario

Objetivo: desenvolver e implementar o sistema de gerenciamento de cirurgias contendo a Lista Cirúrgica e Mapa Cirúrgico. Método: este estudo é de natureza exploratória e descritiva do tipo pesquisa metodológica aplicada. A metodologia utilizada baseia-se no processo de desenvolvimento de software fundamentada no modelo de ciclo de vida de desenvolvimento de sistemas de Pressman. Resultados: o sistema foi desenvolvido e disponibilizado em todos os computadores do hospital em sua rede interna. Implementado em todos as áreas cirúrgicas e Centro Cirúrgico. Conclusão: o sistema de gerenciamento de cirurgias disponibiliza informações em tempo real de informações dos pacientes cirúrgicos a todos setores envolvidos com pacientes cirúrgicos

Objectives: to develop and implement the surgical management system containing the Surgical List and Surgical Map. Method: this study is of exploratory and descriptive nature of the applied methodological research type. The methodology used is based on the software development process based on the Pressman system development life cycle model. Results: the system was developed and made available on all hospital computers on its internal network. Implemented in all surgical areas and Surgical Center. Conclusion: the surgical management system provides real-time information on surgical patient information to all departments involved with surgical patients

Objetivos: desarrollar e implementar el sistema de gestión de cirugías que contenga la Lista Quirúrgica y el Mapa Quirúrgico. Método: este estudio es de naturaleza exploratoria y descriptiva del tipo investigación metodológica aplicada. La metodología utilizada se basa en el proceso de desarrollo de software fundamentada en el modelo de ciclo de vida de desarrollo de sistemas de Pressman. Resultados: el sistema fue desarrollado y puesto a disposición en todas las computadoras del hospital en su red interna. Implementado en todas las áreas quirúrgicas y el Centro Quirúrgico. Conclusión: el sistema de gestión de cirugías proporciona información en tiempo real de los pacientes quirúrgicos a todos los sectores involucrados con pacientes quirúrgicos

Software para apoio à decisão logística no processo de captação e transplante de órgãos / Software de apoyo a la decisión logística en el proceso de obtención y trasplante de órganos / Software to support logistic decision in the process of organ acquisition and transplantation

Objetivo: desenvolver e avaliar um software para apoio à tomada de decisão dos profissionais da central de transplantes nas definições logísticas envolvidas no processo de captação e distribuição de órgãos para transplante. Método: estudo de produção tecnológica aplicada, sustentado pelo método Design Science Research Methodology. Participaram da etapa de avaliação da usabilidade dez enfermeiros da Central de Transplantes de Santa Catarina. A coleta de dados ocorreu de 1 a 20 de julho de 2021 por meio do questionário System Usability Scale. Resultados: o software utilizou linguagem JavaScript com ReactJS e PHP com Laravel, para o banco de dados PostgreSQL. A avaliação obteve escore médio de 98,25, sendo sua usabilidade considerada como melhor alcançável. Conclusão: o software demonstrou ser adequado e funcional, com fácil manuseio, reunindo informações integradas e objetivas. Representa um avanço na área, propondo uma inovação tecnológica para a gestão e apoio às decisões logísticas envolvidas no processo de captação e transplante de órgãos.

Objetivo: desenvolver e avaliar um software para apoio à tomada de decisão dos profissionais da central de transplantes nas definições logísticas envolvidas no processo de captação e distribuição de órgãos para transplante. Método: estudo de produção tecnológica aplicada, sustentado pelo método Design Science Research Methodology. Participaram da etapa de avaliação da usabilidade dez enfermeiros da Central de Transplantes de Santa Catarina. A coleta de dados ocorreu de 1 a 20 de julho de 2021 por meio do questionário System Usability Scale. Resultados: o software utilizou linguagem JavaScript com ReactJS e PHP com Laravel, para o banco de dados PostgreSQL. A avaliação obteve escore médio de 98,25, sendo sua usabilidade considerada como melhor alcançável. Conclusión: o software demonstrou ser adequado e funcional, com fácil manuseio, reunindo informações integradas e objetivas. Representa um avanço na área, propondo uma inovação tecnológica para a gestão e apoio às decisões logísticas envolvidas no processo de captação e transplante de órgãos.

Objective: to develop and evaluate a software to support the decision-making of transplant center professionals in the logistic definitions involved in the process of organ procurement and distribution for transplantation. Method: applied technological production study, supported by the Design Science Research Methodology method. Ten nurses from the Transplant Center of Santa Catarina participated in the usability evaluation stage. Data collection took place from 1 to 20 July 2021 through the System Usability Scale questionnaire. Results: the software used JavaScript language with ReactJS and PHP with Laravel, for the PostgreSQL database. The evaluation obtained a mean score of 98.25, and its usability is considered as best achievable. Conclusion: the software proved to be adequate and functional, with easy handling, gathering integrated and objective information. It represents a breakthrough in the area, proposing a technological innovation for the management and support to the logistic decisions involved in the process of organ procurement and transplantation.

Avaliação de validade de um sistema computacional na identificação de estudos duplicados / Evaluación de la validez de un sistema computacional en la identificación de estudios duplicados / Validity assessment of a computational system in the identification of duplicate studies

Resumo Objetivo Avaliar o desempenho do sistema web "Apoio à Revisão Sistemática" quanto à identificação de referências bibliográficas duplicadas, em comparação a outros programas. Métodos Trata-se de uma pesquisa metodológica que avalia o processo automático de identificação de duplicatas do sistema "Apoio à Revisão Sistemática" (versão 1.0), em comparação ao EndNote X9® e Rayyan® , considerando checagem manual como referência. Foi utilizado um conjunto de estudos relacionados a três temas sobre fibrose cística recuperados das bases de dados Pubmed, Embase e Web of Science. Para avaliação de desempenho, utilizaram-se a sensibilidade, especificidade, acurácia e área sob a curva ROC para cada software, em comparação à referência. Resultados As buscas nas bases de dados resultaram em 1332 estudos, sendo 273 (20,5%) verdadeiros duplicados. Em comparação aos dados de referência, o programa "Apoio à Revisão Sistemática" identificou maior proporção de duplicatas verdadeiras do que os demais. Os valores de sensibilidade, especificidade e acurácia do sistema "Apoio à Revisão Sistemática" apresentaram-se acima de 98%. Conclusão e implicações para a prática O sistema "Apoio à Revisão Sistemática" possui alta sensibilidade, especificidade e acurácia para identificação de estudos duplicados, otimizando o tempo e o trabalho dos revisores da área da saúde.

Resumen Objetivo Evaluar el desempeño del sistema web "Apoyo a la Revisión Sistemática" en cuanto a la identificación de referencias duplicadas en comparación a otros programas. Métodos Se trata de una investigación metodológica que evalúa el proceso automático de desduplicación del sistema web "Apoyo a la Revisión Sistemática" (versión 1.0), en comparación al EndNote X9® y Rayyan®, considerando la verificación manual como referencia. Fue utilizado, como ejemplo, un conjunto de estudios relacionados a tres temas sobre fibrosis quística recuperados de las bases de datos Pubmed, Embase y Web of Science. Se analizó la sensibilidad, especificidad, precisión y el área sobre la curva ROC de los programas. Resultados Las búsquedas en las bases de datos dieron como resultado 1332 estudios, siendo 273 (20,5%) verdaderos duplicados. En comparación a los datos de referencia, el programa "Apoyo a la Revisión Sistemática" identificó mayor proporción de duplicados verdaderos que los demás. Los valores de sensibilidad, especificidad y precisión del sistema "Apoyo a la Revisión Sistemática" fueron superiores a 98%. Conclusión e implicaciones para la práctica El sistema "Apoyo a la Revisión Sistemática" posee alta sensibilidad, especificidad y precisión para identificación de estudios duplicados obtenidos a partir de búsquedas en bases de datos en el área de salud, optimizando el trabajo de investigadores. Palabras clave Exactitud de los Datos; Bases de Datos Bibliográficas; Revisión Sistemática; Sensibilidad y Especificidad; Software.

Abstract Objective To evaluate the performance of the Systematic Review Support web-based system for the identification of duplicate records compared with similar software tools. Methods A methodological study was conducted assessing the automated process of de-duplication performed by the Systematic Review Support web-based system (version 1.0) versus the EndNote X9® and Rayyan® systems, adopting hand-checking as the benchmark reference for comparisons. A set of studies on three topics related to cystic fibrosis retrieved from the Pubmed, Embase and Web of Science electronic databases was used for testing purposes. The sensitivity, specificity, accuracy and area under the ROC curve of the software systems were compared to the benchmark values for performance evaluation. Results The database searches retrieved 1332 studies, of which 273 (20.5%) were true duplicates. The Systematic Review Support tool identified a larger proportion of true duplicates than the other systems tested. The sensitivity, specificity and accuracy of the Systematic Review Support tool exceeded 98%. Conclusion and implications for practice The Systematic Review Support system provided a high level of sensitivity, specificity and accuracy in identifying duplicate studies, optimizing time and effort by reviewers in the health field.

Rating mean of expert judges and asymmetric confidence intervals in content validity: An SPSS syntax

La estimación de la validez de contenido, obtenida mediante el análisis racional de jueces expertos, habitualmente se hace con coeficientes que estandarizan entre 0.0 y 1.0 el juicio de los jueces. Sin embargo, esta estimación también puede expresarse en la métrica de las respuestas de los jueces, en la forma de la media de respuesta, y con intervalos de confianza asimétricos alrededor de esta media. El objetivo del presente manuscrito es implementar un procedimiento para estas estimaciones (media de respuesta e intervalos de confianza asimétricos) en un programa escrito en sintaxis SPSS. Se explica la racionalidad del procedimiento, y se desarrolla un ejemplo aplicado del cálculo. El programa es de distribución libre, solicitándolo a los autores.(AU)

The estimation of content validity, obtained by rational analysis of expert judges, is usually done with coefficients that standardize between 0.0 and 1.0 the judges' judgment. However, this estimate can also be ex-pressed in the metric of the judges' responses, in the form of the response mean, and with asymmetric confidence intervals around this mean. The aim of the present manuscript is to implement a procedure for these esti-mates (response mean and asymmetric confidence intervals) in a program written in SPSS syntax. The rationale of the procedure is explained, and an applied example of the calculation is developed. The program is freely dis-tributed upon request to the authors.

Atomic model validation using the CCP-EM software suite.

Recently, there has been a dramatic improvement in the quality and quantity of data derived using cryogenic electron microscopy (cryo-EM). This is also associated with a large increase in the number of atomic models built. Although the best resolutions that are achievable are improving, often the local resolution is variable, and a significant majority of data are still resolved at resolutions worse than 3 Å. Model building and refinement is often challenging at these resolutions, and hence atomic model validation becomes even more crucial to identify less reliable regions of the model. Here, a graphical user interface for atomic model validation, implemented in the CCP-EM software suite, is presented. It is aimed to develop this into a platform where users can access multiple complementary validation metrics that work across a range of resolutions and obtain a summary of evaluations. Based on the validation estimates from atomic models associated with cryo-EM structures from SARS-CoV-2, it was observed that models typically favor adopting the most common conformations over fitting the observations when compared with the model agreement with data. At low resolutions, the stereochemical quality may be favored over data fit, but care should be taken to ensure that the model agrees with the data in terms of resolvable features. It is demonstrated that further re-refinement can lead to improvement of the agreement with data without the loss of geometric quality. This also highlights the need for improved resolution-dependent weight optimization in model refinement and an effective test for overfitting that would help to guide the refinement process.

Aplicativo web para o acompanhamento de gestantes e perpuéras: produção tecnológica / Web app for the monitoring of pregnant and puerperal women: technological production / Aplicación webpara el seguimiento de gestantes y puérperas: producción tecnológica

OBJETIVO: Descrever o processo de produção de um protótipo de aplicativo web para o acompanhamento de gestantes e puérperas. MÉTODO: Estudo de produção tecnológica, do tipo prototipagem, desenvolvido em cinco etapas: Identificação da relevância de um aplicativo para o acompanhamento online de gestantes e puérperas com a participação de duas usuárias e nove profissionais; modelagem do protótipo; validação da prototipagem; designe implementação do aplicativo em sua forma. RESULTADOS: O aplicativo tem se mostrado uma ferramenta tecnológica de fácil, rápido e seguro acesso, além de importante aliado no atendimento virtual de gestantes e puérperas, minimizando a exposição e o tempo de espera em pronto atendimentos e consultórios profissionais. CONCLUSÃO: O aplicativo web tem ampliado a adesão de usuárias às consultas pré-natais, puericultura e puerpério, possibilitando um novo espaço de atuação profissional para o Enfermeiro.

OBJECTIVE: To describe the production process of a web app prototype to monitor pregnant and puerperal women. METHOD: A technological production study, of the prototyping type, developed in five stages: Identification of the relevance of an app for the online monitoring of pregnant and puerperal women with the participation of two users and nine professionals; prototype modeling; prototyping validation; and design and implementation of the app in its online version. RESULTS: The app has proved to be a technological tool that is easy, fast and safe to access, as well as an important ally in the virtual care of pregnant and puerperal women, minimizing exposure and waiting time in emergency services and professional offices. CONCLUSION: The web app has expanded users' adherence to the prenatal, childcare and postpartum consultations, providing a new space for the nurses' professional practice.

OBJETIVO: Describir el proceso de producción de un prototipo de aplicación web para el seguimiento de gestante y puérperas. MÉTODO: Estudio de producción tecnológica sobre eldesarrollo de un prototipo, realizado en cinco etapas: Identificación de la importancia del uso de una aplicación para el seguimiento onlinede gestante y puérperas con la participación de dos usuarias y nueve profesionales; creación del modelo del prototipo; validación del desarrollo del prototipo; diseño e implementación de la aplicación online. RESULTADOS: La aplicación ha demostrado ser una herramienta tecnológica de acceso fácil, rápido y seguro, además de un importante aliado en la atención virtual de gestante y puérperas, minimizando la exposición y el tiempo de espera en los servicios de emergencia y consultorios profesionales. CONCLUSIÓN: La aplicación webha ampliado la adhesión de las usuarias a las consultas prenatales, puericultura y posparto y habilitó un nuevo espacio para la práctica profesional del enfermero

Estimativa do erro da medida da ingestão energética: validação da versão brasileira do software GloboDiet / Error estimation of energy intake measurement: validation of the Brazilian version of GloboDiet software

Introdução: Todos os métodos existentes para avaliação da dieta estão sujeitos a erros de medida. Um dos principais e mais recorrentes erros de medida da dieta está no relato impreciso da ingestão energética. Embora vários procedimentos sejam utilizados para estimar a subnotificação da ingestão energética (IE), o mais acurado é a água duplamente marcada (ADM) que mensura o gasto energético total em indivíduos fora de confinamento e é usado como padrão-ouro para validar a IE relatada. Objetivo: Validar a versão brasileira do software GloboDiet, R24h computadorizado, quanto à ingestão energética. Metodologia: O estudo foi conduzido no Centro de Pesquisa Clínica e Epidemiológica no Hospital Universitário da Universidade de São Paulo (USP) que sedia o Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) em São Paulo com 101 participantes. Foram coletados dois recordatórios alimentares de 24 horas (R24h) em dias não consecutivos sendo a entrada de dados realizada no GloboDiet, simultaneamente à entrevista. O GloboDiet é uma metodologia padronizada e informatizada que permite conduzir a entrevista do R24h, dirigida por um roteiro padronizado para diminuir erros e assegurar elevada padronização na coleta. Os participantes ingeriram doses de ADM para avaliar o gasto energético (GET); responderam a um questionário de caracterização geral, sendo que este incluía perguntas sobre características individuais como hábitos de estilo de vida e de condição socioeconômica e o nível de atividade física foi classificado de acordo com a versão curta do Questionário Internacional de Atividade Física (IPAQ). Medidas antropométricas de peso, estatura e circunferência da cintura em duplicata foram realizadas com os participantes antes de ingerirem as doses de ADM e no último dia de coleta. O relato implausível foi calculado com a ADM, mas também com as equações preditivas propostas por Goldberg (1991), Black (2000) e McCrory (2002). Resultados: A média da IE foi de 2117Kcal enquanto que a média do GET foi de 2577Kcal. A subestimação da IE avaliada pelo GloboDiet em relação à ADM foi de 16,1% para a população total; observamos maior subestimação da ingestão em homens (16,6%), em idosos (20,2%), em pessoas com sobrepeso (22,5%) e com atividade física moderada a vigorosa (19,7%). A diferença média entre a IE e o GET foi de 460kcal em nível populacional e os limites de concordância foram amplos (limite de concordância superior de 1875kcal e limite de concordância inferior de -2795kcal), com alta dispersão entre os indivíduos. A IE da primeira medida do R24h foi maior quando comparada à IE da segunda medida do R24h na população total sendo essa diferença significativa. Registramos também que a IE da primeira medida do R24h está mais próxima do GET obtido pela ADM. Em relação à classificação dos participantes quanto o relato da IE comparada com a ADM 88,9% dos participantes foram considerados como relatores plausíveis, sendo 9,1% subrelatores e 2% superrelatores. Utilizando as equações preditivas para classificar os participantes quanto ao relato da IE foram 87,9% relatores plausíveis, 10,1% subrelatores e 2% superrelatores com a equação de Goldberg. Utilizando a equação de Black foram 83,8% relatores plausíveis contra 15,2% subrelatores e 1% superrelatores. No caso da equação de McCrory (2002) foram considerados 97% relatores plausíveis, 1% subrrelator es e 2% superrelatores. Conclusão: A versão brasileira do software GloboDiet é um método acurado para avaliar a IE a nível populacional.

Introduction: All existing methods for evaluating diet are subject to measurement errors. One of the main and most recurrent errors in diet measurement is the implausible reporting of energy intake. Although several procedures are used to estimate the underreporting of energy intake (EI), the most accurate is doubly labeled water (DLW), which measures total energy expenditure in individuals outside of confinement and is used as the gold standard to validate the reported EI. Objective: Validate the Brazilian version of the GloboDiet software, computerized R24h, regarding energy intake.Methodology: The study was conducted at the Clinical and Epidemiological Research Center at the University Hospital at University of São Paulo that hosts the Longitudinal Study of Adult Health (ELSA-Brasil) in São Paulo with 101 participants. Two 24-hour food recalls (R24h) were collected on non-consecutive days and the data entry was performed on GloboDiet, simultaneously with the interview. GloboDiet is a standardized and computerized methodology that allows conducting the R24h interview, guided by a standardized script to reduce errors and ensure high standardization in the collection. Participants ingested doses of DLW to assess total energy expenditure (TEE); answered a general characterization questionnaire, which included questions about individual characteristics such as lifestyle habits and socioeconomic status, and the level of physical activity was classified according to the short version of the International Physical Activity Questionnaire (IPAQ). Anthropometric measurements of weight, heightand waist circumference in duplicate were performed with the participants before ingesting the DLW doses and on the last day of collection. The implausible report was calculated with the DLW, but also with the predictive equations proposed by Goldberg (1991), Black (2000) and McCrory (2002). Results: The EI average was 2117Kcal while the TEE average was 2577Kcal. The underestimation of EI evaluated by GloboDiet in relation to DLW was 16.1% for the total population; we observed greater underestimation of intake in men (16.6%), in the elderly (20.2%), in overweight people (22.5%) and with moderate to vigorous physical activity (19.7%). The mean difference between EI and TEE was 460kcal at the population level and the limits of agreement were wide (upper limit of agreement of 1875kcal and lower limit of agreement of -2795kcal), with high dispersion among individuals. The EI of the first measurement of the R24h was higher when compared to the EI of the second measurement of the R24h in the total population, this difference being significant. We also note that the EI of the first measurement of the R24h is closer to the TEE obtained by the ADM. Regarding the classification of participants regarding the report of the EI compared to the DLW, 88.9% of the participants were considered as plausible reporters, with 9.1% being under-reporters and 2% over-reporters. Using the predictive equations to classify the participants in terms of the EI report, 87.9% were plausible reporters, 10.1% under-reporters and 2% over-reporters with the Goldberg equation. Using Black's equation, 83.8% were plausible reporters against 15.2% underreporters and 1% over-reporters. In the case of McCrory's equation (2002), 97% were considered plausible reporters, 1% under-reporters and 2% over-reporters. Conclusion: The Brazilian version of the GloboDiet software is an accurate method to assess EI at the population level.

Desenvolvimento de aplicativo móvel para o acompanhamento pré-natal e validação de conteúdo / Desarrollo de aplicación móvil para el seguimiento de la atención prenatal y validación de contenido / Development of a mobile application for prenatal care and content validation

Resumo Objetivo Desenvolver aplicativo móvel para gestantes em acompanhamento pré-natal e validar o conteúdo. Métodos Estudo metodológico, tecnológico de abordagem quantitativa realizado em três etapas: revisão integrativa de literatura, validação de conteúdo e construção do aplicativo. A revisão foi realizada em Bases de Dados Bibliográficas; em seguida, um instrumento guia foi elaborado abarcando assuntos sobre pré-natal, parto e puerpério, o qual passou por uma validação inicial, por meio de um grupo focal. Para a construção do aplicativo seguiram-se as fases: análise, design, desenvolvimento, implementação e avaliação de especialistas. A construção do aplicativo e validação do conteúdo foi realizada por 21 especialistas, sendo 14 enfermeiros obstetras e 7 profissionais da área de tecnologia da informação e comunicação. Utilizou-se o Índice de Validade de Conteúdo (IVC), considerando como taxa de concordância valores acima de 80%, Concordância interavaliadores e teste não paramétrico de Mann-Whitney para verificação da fase Delphi 1 e 2. Resultados O aplicativo possui 111 telas sobre o pré-natal, parto, puerpério e aleitamento materno, caderneta virtual da gestante, despertador como lembrete de consultas e o menu fale conosco. Após duas rodadas da técnica Delphi, obteve-se concordância entre os especialistas, com índice de validade de conteúdo médio de 0,89. Conclusão O aplicativo obteve IVC geral adequado entre os especialistas, evidenciando que as informações abordadas e a parte técnica do sistema são confiáveis, sendo validado quanto ao conteúdo. Este apresenta-se como uma potencial ferramenta para promoção da saúde, no que concerne ao cuidado no período gravídico-puerperal.

Resumen Objetivo Desarrollar aplicación móvil para gestantes para el seguimiento de la atención prenatal y validar el contenido. Métodos Estudio metodológico, tecnológico de enfoque cuantitativo realizado en tres etapas: revisión integradora de literatura, validación de contenido y elaboración de la aplicación. La revisión fue realizada en bases de datos bibliográficas. Luego, se elaboró un instrumento guía sobre temas relacionados con control prenatal, parto y puerperio, que pasó por una validación inicial, por medio de un grupo focal. Para elaborar la aplicación, se siguieron las siguientes fases: análisis, diseño, desarrollo, implementación y evaluación de especialistas. La elaboración de la aplicación y la validación del contenido fueron realizadas por 21 especialistas, de los cuales 14 eran enfermeros obstetras y siete profesionales del área de tecnologías de la información y la comunicación. Se utilizó el Índice de Validez de Contenido (IVC), considerando como índice de concordancia valores superiores a 80 %, concordancia interevaluadores y prueba no paramétrica de Mann-Whitney para verificación de la fase Delphi 1 y 2. Resultados La aplicación posee 111 pantallas sobre control prenatal, parto, puerperio y lactancia materna, libreta virtual de gestante, alarma como recordatorio de consultas y el menú "contáctenos". Luego de dos rondas del método Delphi, se obtuvo concordancia entre los especialistas, con un índice de validez de contenido promedio de 0,89. Conclusión La aplicación obtuvo un IVC general adecuado entre los especialistas, lo que deja en evidencia que la información abordada y la parte técnica del sistema son confiables y, de esta forma, el contenido es validado. Se presenta como una herramienta potencial para la promoción de la salud, en lo que respecta al cuidado durante el embarazo y el puerperio.

Abstract Objective To develop a mobile application for pregnant women in prenatal care and validate its content. Methods This is a methodological and technological study with a quantitative approach, carried out in three stages: integrative literature review, content validation, and application construction. The review was carried out in bibliographic databases; then, a guide instrument was elaborated covering subjects about prenatal care, childbirth and the puerperium, which underwent an initial validation through a focus group. For the application construction, the following phases were followed: analysis, design, development, implementation and expert assessment. The application construction and content validation were carried out by 21 experts, being 14 obstetric nurses and 7 Information and Communication Technology professionals. Content Validity Index (CVI) was used, considering as an agreement rate values above 80%, inter-rater agreement and Mann-Whitney non-parametric test to verify Delphi 1 and 2 phases. Results The application has 111 screens about prenatal care, childbirth, puerperium and breastfeeding, the pregnant woman's virtual notebook, an alarm clock as a reminder of appointments and the contact us menu. After two rounds Delphi technique rounds, agreement was reached between the experts, with an average Content Validity Index of 0.89. Conclusion The application obtained an adequate general CVI among experts, showing that the information covered and the system's technical part are reliable, being validated in terms of content. This presents itself as a potential instrument for health promotion with regard to care in the pregnancy-puerperal period.

Technology-Assisted Self-Selection of Candidates for Nonprescription Statin Therapy.

BACKGROUND: Although statins reduce cardiovascular morbidity and mortality, only about one-half of eligible patients receive treatment. Safe and appropriate consumer access to statins could have a significant positive public health impact. OBJECTIVES: This study compares the concordance between a participant and clinician assessment of eligibility for statin therapy using a technology-assisted approach. METHODS: A total of 500 participants, 83 with limited literacy, completed an at-home Web-based application to assess appropriateness for treatment with rosuvastatin 5 mg. The Web application is designed to assess eligibility for a moderate-intensity statin based on current guidelines and deny access to individuals with contraindications to rosuvastatin. Subsequently, participants visited a research site where clinicians, blinded to the information the participant entered, performed an independent Web application assessment. The Web application is programmed for 1 of 3 rosuvastatin treatment outcomes: "OK to use," "not right for you," or "ask a doctor." The primary endpoint was the percent of participants whose self-selected eligibility for nonprescription rosuvastatin was concordant with clinician assessment. RESULTS: For the primary endpoint, participant selection for statin therapy was concordant with clinician selection in 481 (96.2%) of 500 participants (95% confidence interval: 94.1%-97.7%), of whom 23 (4.6%) were deemed appropriate and 458 (91.6%) were deemed inappropriate for treatment. Discordance was due to incorrect self-selection ("OK to use") in 3 cases, incorrect rejection ("not right for you") in 14 cases and an incorrect "ask a doctor" outcome in 2 cases. CONCLUSIONS: The use of a technology-assisted approach to consumer self-selection for statin therapy resulted in participant self-selection that showed substantial agreement with clinician selection.

Automated Prediction of Cardiorespiratory Deterioration in Patients With Single Ventricle.

BACKGROUND: Patients with single-ventricle physiology have a significant risk of cardiorespiratory deterioration between their first and second stage palliation surgeries. OBJECTIVES: The objective of this study is to develop and validate a real-time computer algorithm that can automatically recognize physiological precursors of cardiorespiratory deterioration in children with single-ventricle physiology during their interstage hospitalization. METHODS: A retrospective study was conducted from prospectively collected physiological data of subjects with single-ventricle physiology. Deterioration events were defined as a cardiac arrest requiring cardiopulmonary resuscitation or an unplanned intubation. Physiological metrics were derived from the electrocardiogram (heart rate, heart rate variability, ST-segment elevation, and ST-segment variability) and the photoplethysmogram (peripheral oxygen saturation and pleth variability index). A logistic regression model was trained to separate the physiological dynamics of the pre-deterioration phase from all other data generated by study subjects. Data were split 50/50 into model training and validation sets to enable independent model validation. RESULTS: Our cohort consisted of 238 subjects admitted to the cardiac intensive care unit and stepdown units of Texas Children's Hospital over a period of 6 years. Approximately 300,000 h of high-resolution physiological waveform and vital sign data were collected using the Sickbay software platform (Medical Informatics Corp., Houston, Texas). A total of 112 cardiorespiratory deterioration events were observed. Seventy-two of the subjects experienced at least 1 deterioration event. The risk index metric generated by our optimized algorithm was found to be both sensitive and specific for detecting impending events 1 to 2 h in advance of overt extremis (receiver-operating characteristic curve area: 0.958; 95% confidence interval: 0.950 to 0.965). CONCLUSIONS: Our algorithm can provide 1 to 2 h of advanced warning for 62% of all cardiorespiratory deterioration events in children with single-ventricle physiology during their interstage period, with only 1 alarm being generated at the bedside per patient per day.

Test Case Generation to Medical Cyber-Physical Systems: A Scoping Review / Geração de Casos de Teste para Sistemas Médicos Físico-Cibernéticos: Uma Revisão de Escopo / Generación de Casos de Prueba para Sistemas Médicos Físico-Cibernéticos: Una Revisión de Alcance

Objective: This article presents a Scoping Review (ScR) identify the approaches to automatically generate test cases from Cyber-Physical Systems (CPS) models, more specifically, Medical Cyber-Physical Systems (MCPS) models. Method: ScR was performed by identifying indexed articles in five electronic databases using a specific search string and selection criteria, defined in a review protocol. Results: When protocol was executed, 467 studies were returned, from which 12 were summarized. Several formal and semi-formal notations used in CPS modeling were identified, as well as tools for generating test cases for such systems. Furthermore, we present an overview of the state-of-the-art regarding automatic test case generation for such systems models. Conclusion: Based on the results, we conclude there is a research gap with regard to tools for the fully automatic test case generation in MCPS.

Objetivo: Este artigo apresenta uma Revisão de Escopo (RE) para identificar as abordagens para gerar automaticamente casos de testes a partir de modelos de Sistemas Físico-Cibernéticos (SFC), mais especificamente, Sistemas Médicos Físico-Cibernéticos (SMFC). Método: A RE foi realizada pela identificação de trabalhos indexados em cinco bases eletrônicas de dados usando termos de busca e critérios de inclusão, definidos em um protocolo de revisão. Resultados: Ao executar o protocolo foram retornados 467 estudos, dos quais sumarizaram-se 12. Foram identificadas várias notações formais e semi-formais usadas na modelagem de SFC, bem como ferramentas para gerar casos de teste para esses sistemas. Além disso, foi apresentada uma visão geral do estado da arte em relação à geração automática de casos de teste para esses modelos de sistemas. Conclusão: Com base nos resultados obtidos, conclui-se que ainda há uma lacuna de pesquisa no que diz respeito às ferramentas para a geração totalmente automática de casos de teste para SMFC.

Objectivo: En este artículo se presenta una Revisión de Alcance (RA) para identificar los enfoques para generar automáticamente casos de prueba a partir de modelos de Sistemas Físico-Cibernéticos (SFC), más específicamente, Sistemas Médicos Físico-Cibernéticos (SMFC). Método: La RA se realizó mediante la identificación de artículos indexados en cinco bases de datos electrónicas utilizando términos de búsqueda y criterios de selección, definidos en un protocolo de revisión. Resultados: Al ejecutar el protocolo se devolvieron 467 estudios, de los cuales se resumieron 12. Se han identificado varias notaciones formales y semiformales utilizadas en el modelado de SFC y SMFC, así como herramientas para generar casos de prueba para estos sistemas. Además, se presentó una descripción general del estado del arte en relación a la generación automática de casos de prueba para estos modelos de sistema. Conclusión: Con base a los resultados obtenidos, se concluye que hay una brecha de investigación con respecto a las herramientas para la generación de casos de prueba totalmente automática en MCPS.

Code Review as a Simple Trick to Enhance Reproducibility, Accelerate Learning, and Improve the Quality of Your Team's Research.

Programming for data wrangling and statistical analysis is an essential technical tool of modern epidemiology, yet many epidemiologists receive limited formal training in strategies to optimize the quality of our code. In complex projects, coding mistakes are easy to make, even for skilled practitioners. Such mistakes can lead to invalid research claims that reduce the credibility of the field. Code review is a straightforward technique used by the software industry to reduce the likelihood of coding bugs. The systematic implementation of code review in epidemiologic research projects could not only improve science but also decrease stress, accelerate learning, contribute to team building, and codify best practices. In the present article, we argue for the importance of code review and provide some recommendations for successful implementation for 1) the research laboratory, 2) the code author (the initial programmer), and 3) the code reviewer. We outline a feasible strategy for implementation of code review, though other successful implementation processes are possible to accommodate the resources and workflows of different research groups, including other practices to improve code quality. Code review isn't always glamorous, but it is critically important for science and reproducibility. Humans are fallible; that's why we need code review.

Rationale and design of a large population study to validate software for the assessment of atrial fibrillation from data acquired by a consumer tracker or smartwatch: The Fitbit heart study.

BACKGROUND: Early detection of atrial fibrillation or flutter (AF) may enable prevention of downstream morbidity. Consumer wrist-worn wearable technology is capable of detecting AF by identifying irregular pulse waveforms using photoplethysmography (PPG). The validity of PPG-based software algorithms for AF detection requires prospective assessment. METHODS: The Fitbit Heart Study (NCT04380415) is a single-arm remote clinical trial examining the validity of a novel PPG-based software algorithm for detecting AF. The proprietary Fitbit algorithm examines pulse waveform intervals during analyzable periods in which participants are sufficiently stationary. Fitbit consumers with compatible wrist-worn trackers or smartwatches were invited to participate. Enrollment began May 6, 2020 and as of October 1, 2020, 455,699 participants enrolled. Participants in whom an irregular heart rhythm was detected were invited to attend a telehealth visit and eligible participants were then mailed a one-week single lead electrocardiographic (ECG) patch monitor. The primary study objective is to assess the positive predictive value of an irregular heart rhythm detection for AF during the ECG patch monitor period. Additional objectives will examine the validity of irregular pulse tachograms during subsequent heart rhythm detections, self-reported AF diagnoses and treatments, and relations between irregular heart rhythm detections and AF episode duration and time spent in AF. CONCLUSIONS: The Fitbit Heart Study is a large-scale remote clinical trial comprising a unique software algorithm for detection of AF. The study results will provide critical insights into the use of consumer wearable technology for AF detection, and for characterizing the nature of AF episodes detected using consumer-based PPG technology.

A model to establish autoverification in the clinical laboratory.

OBJECTIVES: Autoverification is the process of evaluating and validating laboratory results using predefined computer-based algorithms without human interaction. By using autoverification, all reports are validated according to the standard evaluation criteria with predefined rules, and the number of reports per laboratory specialist is reduced. However, creating and validating these rules are the most demanding steps for setting up an autoverification system. In this study, we aimed to develop a model for helping users establish autoverification rules and evaluate their validity and performance. DESIGN & METHODS: The proposed model was established by analyzing white papers, previous study results, and national/international guidelines. An autoverification software (myODS) was developed to create rules according to the model and to evaluate the rules and autoverification rates. The simulation results that were produced by the software were used to demonstrate that the determined framework works as expected. Both autoverification rates and step-based evaluations were performed using actual patient results. Two algorithms defined according to delta check usage (Algorithm A and B) and three review limits were used for the evaluation. RESULTS: Six hundred seventeen rules were created according to the proposed model. 1,976 simulation results were created for validation. Our results showed that manual review limits are the most critical step in determining the autoverification rate, and delta check evaluation is especially important for evaluating inpatients. Algorithm B, which includes consecutive delta check evaluation, had higher AV rates. CONCLUSIONS: Systemic rule formation is a critical factor for successful AV. Our proposed model can help laboratories establish and evaluate autoverification systems. Rules created according to this model could be used as a starting point for different test groups.

Quantitative imaging decision support (QIDSTM) tool consistency evaluation and radiomic analysis by means of 594 metrics in lung carcinoma on chest CT scan.

OBJECTIVE: To evaluate the consistency of the quantitative imaging decision support (QIDSTM) tool and radiomic analysis using 594 metrics in lung carcinoma on chest CT scan. MATERIALS AND METHODS: We included, retrospectively, 150 patients with histologically confirmed lung cancer who underwent chemotherapy and baseline and follow-ups CT scans. Using the QIDSTM platform, 3 radiologists segmented each lesion and automatically collected the longest diameter and the density mean value. Inter-observer variability, Bland Altman analysis and Spearman's correlation coefficient were performed. QIDSTM tool consistency was assessed in terms of agreement rate in the treatment response classification. Kruskal Wallis test and the least absolute shrinkage and selection operator (LASSO) method with 10-fold cross validation were used to identify radiomic metrics correlated with lesion size change. RESULTS: Good and significant correlation was obtained between the measurements of largest diameter and of density among the QIDSTM tool and the radiologists measurements. Inter-observer variability values were over 0.85. HealthMyne QIDSTM tool quantitative volumetric delineation was consistent and matched with each radiologist measurement considering the RECIST classification (80-84%) while a lower concordance among QIDSTM and the radiologists CHOI classification was observed (58-63%). Among 594 extracted metrics, significant and robust predictors of RECIST response were energy, histogram entropy and uniformity, Kurtosis, coronal long axis, longest planar diameter, surface, Neighborhood Grey-Level Different Matrix (NGLDM) dependence nonuniformity and low dependence emphasis as Volume, entropy of Log(2.5 mm), wavelet energy, deviation and root man squared. CONCLUSION: In conclusion, we demonstrated that HealthMyne quantitative volumetric delineation was consistent and that several radiomic metrics extracted by QIDSTM were significant and robust predictors of RECIST response.

A proof-of-concept study of the in-vivo validation of a computational fluid dynamics model of personalized radioembolization.

Radioembolization (RE) with yttrium-90 (90Y) microspheres, a transcatheter intraarterial therapy for patients with liver cancer, can be modeled computationally. The purpose of this work was to correlate the results obtained with this methodology using in vivo data, so that this computational tool could be used for the optimization of the RE procedure. The hepatic artery three-dimensional (3D) hemodynamics and microsphere distribution during RE were modeled for six 90Y-loaded microsphere infusions in three patients with hepatocellular carcinoma using a commercially available computational fluid dynamics (CFD) software package. The model was built based on in vivo data acquired during the pretreatment stage. The results of the simulations were compared with the in vivo distribution assessed by 90Y PET/CT. Specifically, the microsphere distribution predicted was compared with the actual 90Y activity per liver segment with a commercially available 3D-voxel dosimetry software (PLANET Dose, DOSIsoft). The average difference between the CFD-based and the PET/CT-based activity distribution was 2.36 percentage points for Patient 1, 3.51 percentage points for Patient 2 and 2.02 percentage points for Patient 3. These results suggest that CFD simulations may help to predict 90Y-microsphere distribution after RE and could be used to optimize the RE procedure on a patient-specific basis.