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.

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.

Software para análise do dimensionamento de pessoal de enfermagem validado em obstetrícia / Software for analyzing nursing staff sizing validated in obstetrics

Trata-se do relatório de pesquisa da dissertação apresentada ao Programa de Pós-Graduação em Prática do Cuidado em Saúde da Universidade Federal do Paraná (UFPR), inserida na linha de pesquisa Processo de Cuidar em Saúde e Enfermagem com o tema: software para análise do dimensionamento de enfermagem validado nos setores de obstetrícia como tecnologia auxiliar da gestão do cuidado, no qual o objetivo foi desenvolver e validar um software para análise do dimensionamento de pessoal de enfermagem. Método: pesquisa metodológica aplicada, de produção tecnológica de engenharia de software segundo o referencial teórico de Pressmann (2011) e Sommerville (2003) fundamentado na Resolução Cofen 543/ 2017 e para validação de conteúdo de enfermagem adaptado de Sperandio (2008), Pereira (2011), Jensen (2012) e Friedrich (2019); avaliação de qualidade técnica, de usabilidade e de informática pelo Modelo do Processo de Avaliação (MPA) segundo a Norma Brasileira International Organization for Standardization/ International Eletrotechnical Comission (NBR ISO/ IEC); ISO/IEC 14598-6 2004, ISO/ IEC 25010: 2011 e ISO/ IEC 25000: 2014. O cenário do estudo é a maternidade/ serviço obstétrico do Complexo Hospital de Clínicas da UFPR, um hospital de grande porte e referência para atendimento de alto risco em obstetrícia. O desenvolvimento metodológico contou com a eleição dos descritores e pesquisa da literatura pertinente em bases de dados científica, seguiu o esboço, prototipagem, programação e arte final das telas (interfaces) do software conjuntamente a um profissional de informática (programador) e após a validação do produto junto a dezesseis juízes especialistas, sendo oito da enfermagem e oito da informática. Resultados: na avaliação da qualidade de sistemas, dos juízes especialistas de enfermagem a característica de adequação funcional recebeu o percentual de 81,25% dos valores pontuados, a de compatibilidade de 87,50%, a de segurança de 100%, a de confiabilidade de 75%, a usabilidade 79,68% e eficiência e desempenho 100%. Os juízes especialistas de informática avaliaram pontuando os valores da característica de adequação funcional em 90%, de compatibilidade em 70,83%, de segurança em 100%, de confiabilidade em 87,55, de usabilidade em 82,81%, de eficiência e desempenho em 100%, de manutenibilidade em 71,87% e portabilidade em 68,75%. Conclusão: a pesquisa culminou com o desenvolvimento do software DIMENF para análise do dimensionamento de pessoal de enfermagem, como produto dessa dissertação. O DIMENF servirá como ferramenta prática, que contempla dados agrupados do dimensionamento de pessoal das diferentes áreas hospitalares, seja de internação, apoio, diagnóstico, centro cirúrgico ou ambulatorial, de forma a auxiliar a gestão do cuidado e permitir ao enfermeiro adequar as necessidades de recursos humanos de enfermagem às necessidades assistenciais dos usuários dos serviços de saúde, tanto para garantir a segurança do paciente e qualidade assistencial, quanto para oferecer adequadas condições de trabalho aos profissionais de enfermagem.

This is the research report of the dissertation presented to the Postgraduate Program in Health Care Practice at the Federal University of Paraná (UFPR), inserted in the line of research Process of Caring for Health and Nursing with the theme: software for analysis of nursing sizing validated in the obstetrics sectors as an auxiliary technology for care management, without the objective of developing and validating software for analyzing the sizing of nursing staff. Method: applied methodological research, of technological production of software engineering according to the theoretical framework of Pressmann (2011) and Sommerville (2003) based on Resolution Cofen 543/2017 and for validation of nursing content adapted from Sperandio (2008), Pereira (2011), Jensen (2012) and Friedrich (2019); evaluation of technical quality, usability and information technology by the Evaluation Process Model (MPA) according to the Brazilian Standard International Organization for Standardization/ International Electrotechnical Commission (NBR ISO/ IEC); ISO/ IEC 14598-6 2004, ISO/ IEC 25010: 2011 and ISO/ IEC 25000: 2014. The scenario of the study is the maternity / obstetric service of the Hospital de Clínicas Complex of UFPR, a large hospital and a reference for the care of high risk in obstetrics. The methodological development included the selection of descriptors and research of the relevant literature in scientific databases, followed the outline, prototyping, programming and final art of the screens (interfaces) of the software together with a computer professional (programmer) and after validation of the product with sixteen expert judges, eight from nursing and eight from information technology. Results: when assessing the quality of systems, from the expert nursing judges, the characteristic of functional adequacy received the percentage of 81.25% of the scored values, the compatibility of 87.50%, the safety of 100%, the reliability 75%, usability 79.68% and efficiency and performance 100%. The IT experts judged by scoring the values of the characteristic of functional adequacy at 90%, compatibility at 70.83%, security at 100%, reliability at 87.55, usability at 82.81%, efficiency and performance at 100%, maintainability at 71.87% and portability at 68.75%. Conclusion: the research culminated in the development of the DIMENF software for analyzing the dimensioning of nursing staff, as a product of this dissertation. The DIMENF will serve as a practical tool, which includes grouped data on the dimensioning of personnel from different hospital areas, whether inpatient, support, diagnosis, surgical or outpatient centers, in order to assist the management of care and allow nurses to adapt resource needs. Nursing staff to the care needs of users of health services, both to ensure patient safety and care quality, and to provide adequate working conditions for nursing professionals.

Assessment of Turkey IVF (In Vitro Fertilization) websites according to the American Society for Reproductive Medicine (ASRM)/Society for Assisted Reproductive Technology (SART) guidelines.

OBJECTIVE: To evaluate websites of in-vitro fertilisation centres in terms of standardised ethical guidelines for advertising. METHODS: The cross-sectional study was conducted in Turkey from February to April 2017. A total of 148 IVF centre websites were evaluated in terms of objective criteria in accordance with American Medical Association, American College of Obstetricians and Gynaecologists, American Society for Reproductive Medicine / Society for Assisted Reproductive. Technology guidelines for advertising. Websites were surveyed with attention paid to success rates, testimonials, sales promotions, price, psychological support offered as part of the service, regulating / certifying bodies, misleading language, and the ethical principles of autonomy, beneficence, non-maleficence and justice. Data was analysed using SPSS 23. RESULTS: Out of 193 centres, 148(76.7%) had active websites; 104(70.3%) private, 38(25.7%) in university hospitals and 6(4%) in state hospitals. Of them, 103(69.6%) centres used at least one example of misleading language when compared to the relevant guidelines. Among these centres, 82(79.6%) were private, 18(17.5%) university hospitals and 3(2.9%) were state hospitals. CONCLUSIONS: A massive majority of websites related to in-vitro fertilisation centres did not follow standardised guidelines for advertising.

Platform for automatic patient quality assurance via Monte Carlo simulations in proton therapy.

For radiation therapy, it is crucial to ensure that the delivered dose matches the planned dose. Errors in the dose calculations done in the treatment planning system (TPS), treatment delivery errors, other software bugs or data corruption during transfer might lead to significant differences between predicted and delivered doses. As such, patient specific quality assurance (QA) of dose distributions, through experimental validation of individual fields, is necessary. These measurement based approaches, however, are performed with 2D detectors, with limited resolution and in a water phantom. Moreover, they are work intensive and often impose a bottleneck to treatment efficiency. In this work, we investigated the potential to replace measurement-based approach with a simulation-based patient specific QA using a Monte Carlo (MC) code as independent dose calculation engine in combination with treatment log files. Our developed QA platform is composed of a web interface, servers and computation scripts, and is capable to autonomously launch simulations, identify and report dosimetric inconsistencies. To validate the beam model of independent MC engine, in-water simulations of mono-energetic layers and 30 SOBP-type dose distributions were performed. Average Gamma passing ratio 99 ± 0.5% for criteria 2%/2 mm was observed. To demonstrate feasibility of the proposed approach, 10 clinical cases such as head and neck, intracranial indications and craniospinal axis, were retrospectively evaluated via the QA platform. The results obtained via QA platform were compared to QA results obtained by measurement-based approach. This comparison demonstrated consistency between the methods, while the proposed approach significantly reduced in-room time required for QA procedures.

Radiographic predictors determined with an objective assessment tool for neonatal patients with necrotizing enterocolitis / Preditores radiográficos determinados com uso de ferramenta de avaliação objetiva para pacientes neonatais com enterocolite necrotizante

ABSTRACT Objective: The objective of this study was to develop and validate a computational tool to assist radiological decisions on necrotizing enterocolitis. Methodology: Patients that exhibited clinical signs and radiographic evidence of Bell's stage 2 or higher were included in the study, resulting in 64 exams. The tool was used to classify localized bowel wall thickening and intestinal pneumatosis using full-width at half-maximum measurements and texture analyses based on wavelet energy decomposition. Radiological findings of suspicious bowel wall thickening and intestinal pneumatosis loops were confirmed by both patient surgery and histopathological analysis. Two experienced radiologists selected an involved bowel and a normal bowel in the same radiography. The full-width at half-maximum and wavelet-based texture feature were then calculated and compared using the Mann-Whitney U test. Specificity, sensibility, positive and negative predictive values were calculated. Results: The full-width at half-maximum results were significantly different between normal and distended loops (median of 10.30 and 15.13, respectively). Horizontal, vertical, and diagonal wavelet energy measurements were evaluated at eight levels of decomposition. Levels 7 and 8 in the horizontal direction presented significant differences. For level 7, median was 0.034 and 0.088 for normal and intestinal pneumatosis groups, respectively, and for level 8 median was 0.19 and 0.34, respectively. Conclusions: The developed tool could detect differences in radiographic findings of bowel wall thickening and IP that are difficult to diagnose, demonstrating the its potential in clinical routine. The tool that was developed in the present study may help physicians to investigate suspicious bowel loops, thereby considerably improving diagnosis and clinical decisions.

RESUMO Objetivo: O objetivo deste estudo foi desenvolver e validar uma ferramenta computacional para auxiliar as decisões radiológicas na enterocolite necrotizante. Metodologia: Pacientes que exibiam sinais clínicos e evidências radiográficas do estágio 2 ou superior de Bell foram incluídos no estudo, que resultou em 64 exames. A ferramenta foi usada para classificar o aumento localizado da espessura da parede intestinal e a pneumatose intestinal com medidas de largura total a meia altura e análises de textura baseadas na decomposição da energia wavelet. Os achados radiológicos de aumento suspeito da espessura da parede intestinal e das alças na pneumatose intestinal foram confirmados pela cirurgia e análise histopatológica do paciente. Dois radiologistas experientes selecionaram um intestino afetado e um intestino normal na mesma radiografia. A largura total a meia altura e a característica da textura baseada em wavelet foram então calculadas e comparadas com o uso do teste U de Mann-Whitney. Foram calculados a especificidade, sensibilidade, valores preditivos positivos e negativos. Resultados: Os resultados da largura total a meia altura foram significativamente diferentes entre a alça normal e a distendida (mediana de 10,30 e 15,13, respectivamente). Medidas de energia wavelet horizontal, vertical e diagonal foram avaliadas em oito níveis de decomposição. Os níveis 7 e 8 na direção horizontal apresentaram diferenças significativas. Para o nível 7, as medianas foram 0,034 e 0,088 para os grupos normal e com pneumatose intestinal, respectivamente, e para o nível 8, as medianas foram 0,19 e 0,34, respectivamente. Conclusões: A ferramenta desenvolvida pode detectar diferenças nos achados radiográficos do aumento da espessura da parede intestinal e PI de difícil diagnóstico, demonstra seu potencial na rotina clínica. A ferramenta desenvolvida no presente estudo pode ajudar os médicos a investigar alças intestinais suspeitas e melhorar consideravelmente o diagnóstico e as decisões clínicas.

Radiographic predictors determined with an objective assessment tool for neonatal patients with necrotizing enterocolitis.

OBJECTIVE: The objective of this study was to develop and validate a computational tool to assist radiological decisions on necrotizing enterocolitis. METHODOLOGY: Patients that exhibited clinical signs and radiographic evidence of Bell's stage 2 or higher were included in the study, resulting in 64 exams. The tool was used to classify localized bowel wall thickening and intestinal pneumatosis using full-width at half-maximum measurements and texture analyses based on wavelet energy decomposition. Radiological findings of suspicious bowel wall thickening and intestinal pneumatosis loops were confirmed by both patient surgery and histopathological analysis. Two experienced radiologists selected an involved bowel and a normal bowel in the same radiography. The full-width at half-maximum and wavelet-based texture feature were then calculated and compared using the Mann-Whitney U test. Specificity, sensibility, positive and negative predictive values were calculated. RESULTS: The full-width at half-maximum results were significantly different between normal and distended loops (median of 10.30 and 15.13, respectively). Horizontal, vertical, and diagonal wavelet energy measurements were evaluated at eight levels of decomposition. Levels 7 and 8 in the horizontal direction presented significant differences. For level 7, median was 0.034 and 0.088 for normal and intestinal pneumatosis groups, respectively, and for level 8 median was 0.19 and 0.34, respectively. CONCLUSIONS: The developed tool could detect differences in radiographic findings of bowel wall thickening and IP that are difficult to diagnose, demonstrating the its potential in clinical routine. The tool that was developed in the present study may help physicians to investigate suspicious bowel loops, thereby considerably improving diagnosis and clinical decisions.

Linguistic Validation of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Korean.

PURPOSE: The aim of this study was to translate and linguistically validate a Korean-language version of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). METHODS: All 124 PRO-CTCAE items were translated into Korean (PRO-CTCAE-Korean) using International Society for Pharmacoeconomics and Outcomes Research best practices and linguistically validated in a diverse sample of patients undergoing cancer treatment (n = 120) to determine whether the Korean translation captured the original concepts. During the cognitive interviews, participants first completed approximately 60 PRO-CTCAE-Korean questions and were then interviewed to evaluate the conceptual equivalence of the translation to the original PRO-CTCAE English-language source. Interview probes addressed comprehension, clarity, and ease of judgement. Three rounds of interviews were conducted. Items that met the a priori threshold of 10% or more of respondents with comprehension difficulties were considered for rephrasing and retesting. RESULTS: A majority of PRO-CTCAE-Korean items were well comprehended in round 1; 14 items posed comprehension difficulties for at least 10% of respondents in round 1. Four symptom terms (mouth and throat sores, feeling like nothing could cheer you up, frequent urination, and pain, swelling, redness at drug injection or intravenous insertion site) were revised and retested in rounds 2 and 3. For the other 10 symptom terms, no suitable alternative phrasing was identified, and the terms were retested in rounds 2 and 3. After rounds 2 and 3, no item presented difficulties in 20% or more of participants. CONCLUSION: PRO-CTCAE-Korean has been linguistically validated for use in Korean-speaking populations. Quantitative evaluation of this new measure to establish its measurement properties and responsiveness in Korean speakers undergoing cancer treatment is in progress.

A Systematic Review of All Smart Phone Applications Specifically Aimed for Use as a Scoliosis Screening Tool.

The scoliometer is an inclinometer commonly used in scoliosis screening. The device is used during an Adam's forward bend test, in which a patient bends forward at the hips to measure deformity of the rib cage and spinal column. If a sufficient angle of rotation is measured, then the appropriate referrals and x-rays can be made and taken. This ubiquitous screening tool allows for a quick and simple scoliosis screening and is a mainstay of scoliosis management. With the advent and rapid improvement of smart phone technology, many scoliometer applications have become readily accessible. Our study was designed to test the accuracy, precision, and calibration of several scoliometer applications available on both the Apple iPhone and Samsung Galaxy platforms. Application cost was also analyzed to assess the plausibility of using a smartphone scoliometer application in place of a traditional scoliometer in a traditional scoliosis screening. Our data show that available smart phone applications can be used effectively and that, in a controlled environment, some applications performed better than a traditional scoliometer. Application price was not correlated with effectiveness; the cost-free application performed better than the for-purchase application.

[Legal framework for E­health products on the European market]. / Medizinprodukterechtliche Rahmenbedingungen für E­Health-Produkte im europäischen Wirtschaftsraum.

Legitimately categorizing software in the healthcare sector is complex. According to European medical devices law, software can be considered a medical device. The decisive factor is whether the software is used for directly controlling a therapeutic or diagnostic medical device or as stand-alone software that achieves specific medical purposes, as they are described in the legal definition of a medical device. A contribution of the software to diagnosis or therapy can be sufficient for the categorization; it does not have to provide the complete diagnosis or the complete therapy itself.This principle will continue to be the same with the new Regulation on Medical Devices (EU) 2017/745, even though the classification rules have been more closely and more specifically tailored to software and more stringent requirements for essential safety and performance requirements have to be met.

[Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority]. / Medizinische Software/Medical Apps : Aufgaben, Anforderungen und Erfahrungen aus Sicht einer Überwachungsbehörde.

Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.

Initial experience with a new quantitative assessment tool for fluorescent imaging in peripheral artery disease.

BACKGROUND: Perioperative evaluation in peripheral artery disease (PAD) by common vascular diagnostic tools is limited by open wounds, medial calcinosis or an altered collateral supply of the foot. Indocyanine green fluorescent imaging (ICG-FI) has recently been introduced as an alternative tool, but so far a standardized quantitative assessment of tissue perfusion in vascular surgery has not been performed for this purpose. The aim of this feasibility study was to investigate a new software for quantitative assessment of tissue perfusion in patients with PAD using indocyanine green fluorescent imaging (ICG-FI) before and after peripheral bypass grafting. PATIENTS AND METHODS: Indocyanine green fluorescent imaging was performed in seven patients using the SPY Elite system before and after peripheral bypass grafting for PAD (Rutherford III-VI). Visual and quantitative evaluation of tissue perfusion was assessed in an area of low perfusion (ALP) and high perfusion (AHP), each by three independent investigators. Data assessment was performed offline using a specially customized software package (Institute for Laser Technology, University Ulm, GmbH). Slope of fluorescent intensity (SFI) was measured as time-intensity curves. Values were compared to ankle-brachial index (ABI), slope of oscillation (SOO), and time to peak (TTP) obtained from photoplethysmography (PPG). RESULTS: All measurements before and after surgery were successfully performed, showing that ABI, TTP, and SOO increased significantly compared to preoperative values, all being statistically significant (P < 0.05), except for TTP (p = 0.061). Further, SFI increased significantly in both ALP and AHP (P < 0.05) and correlated considerably with ABI, TTP, and SOO (P < 0.05). CONCLUSIONS: In addition to ABI and slope of oscillation (SOO), the ICG-FI technique allows visual assessment in combination with quantitative assessment of tissue perfusion in patients with PAD. Ratios related to different perfusion patterns and SFI seem to be useful tools to reduce factors disturbing ICG-FI measurements.

Validation of a free software for unsupervised assessment of abdominal fat in MRI.

PURPOSE: To demonstrate the accuracy of an unsupervised (fully automated) software for fat segmentation in magnetic resonance imaging. The proposed software is a freeware solution developed in ImageJ that enables the quantification of metabolically different adipose tissues in large cohort studies. METHODS: The lumbar part of the abdomen (19cm in craniocaudal direction, centered in L3) of eleven healthy volunteers (age range: 21-46years, BMI range: 21.7-31.6kg/m2) was examined in a breath hold on expiration with a GE T1 Dixon sequence. Single-slice and volumetric data were considered for each subject. The results of the visceral and subcutaneous adipose tissue assessments obtained by the unsupervised software were compared to supervised segmentations of reference. The associated statistical analysis included Pearson correlations, Bland-Altman plots and volumetric differences (VD%). RESULTS: Values calculated by the unsupervised software significantly correlated with corresponding supervised segmentations of reference for both subcutaneous adipose tissue - SAT (R=0.9996, p<0.001) and visceral adipose tissue - VAT (R=0.995, p<0.001). Bland-Altman plots showed the absence of systematic errors and a limited spread of the differences. In the single-slice analysis, VD% were (1.6±2.9)% for SAT and (4.9±6.9)% for VAT. In the volumetric analysis, VD% were (1.3±0.9)% for SAT and (2.9±2.7)% for VAT. CONCLUSIONS: The developed software is capable of segmenting the metabolically different adipose tissues with a high degree of accuracy. This free add-on software for ImageJ can easily have a widespread and enable large-scale population studies regarding the adipose tissue and its related diseases.

Construção e validação de um software para avaliação da satisfação no trabalho da enfermagem / Construction and validity of software to evaluate Nursing Work Satisfaction

A satisfação no trabalho pode ser caracterizada como o resultado positivo (prazeroso) das relações sociais e experiências vividas pelos trabalhadores no ambiente de trabalho. Ela se é subjetiva e se relaciona intrinsecamente com os vínculos afetivos diversos que permeiam as relações e sensações humanas que se apresentam além dos espaços físicos das instituições de trabalho. Ao longo do tempo, a satisfação tem se mostrado como fator contribuinte para a permanência dos indivíduos nas organizações e como fonte geradora de saúde e bem-estar no trabalho. Nesse contexto, o uso inovador da tecnologia em saúde pode determinar avanços relacionados à qualidade do cuidado e à melhoria da qualidade de vida das pessoas. Considerando a possibilidade de avanço científico na enfermagem por meio do uso de tecnologias informatizadas, buscou-se desenvolver este estudo no intuito de desenvolver um software para avaliar a satisfação no trabalho da enfermagem. Trata-se de uma pesquisa aplicada que utilizou o referencial teórico da satisfação do trabalho na enfermagem de Mirlene Maria Matias Siqueira, e a metodologia de desenvolvimento de software de Viviane Bernardo. Como objetivo, buscou-se o desenvolvimento de um projeto de multimídia (software) para avaliação da satisfação no trabalho da enfermagem. Esta pesquisa ocorreu em duas fases: construção do projeto de multimídia e sua validação. Na fase de construção do projeto seguiu-se as seguintes etapas: definição do escopo, planejamento e produção. Na fase de validação de aparência e de conteúdo do software, foram realizadas as validações do projeto quanto: à aparência; ao conteúdo; à usabilidade; e à aceitabilidade. As avaliações foram feitas por um Comitê de Juízes especialistas na temática. Para avaliação de ergonomia e usabilidade, o software foi avaliado por 3 especialistas da área de Tecnologia da Informação. Para avaliação de conteúdo e aparência, o software foi avaliado por 3 docentes de Enfermagem. Após as validações de especialistas, houve ajustes na ferramenta e posteriormente teste de aceitabilidade foi realizado. Participaram 11 trabalhadores da equipe de enfermagem. Ao final desta pesquisa o produto desenvolvido foi um software destinado à Avaliação da Satisfação no Trabalho da Enfermagem, intitulado "WorkSatisfaction". Por fim, concluímos que o processo de construção e validação realizado neste estudo pode contribuir para o avanço do uso da tecnologia no ensino, na pesquisa e na prática em saúde e enfermagem

Job satisfaction can be characterized as the positive (pleasurable) outcome of social relationships and experiences lived by workers in the work environment. It is subjective and intrinsically related to the diverse affective bonds that permeate human relations and sensations that are welcomed by the physical banks of the work institutions. Over time, a satisfaction has been announced as a contributor to a permanence of law in organizations and as a source of health and well-being without work. In this context, the innovative use of health technology can determine advances related to the quality of care and the improvement of people's quality of life. No method was found to evaluate a study to evaluate the research without nursing work. This is an applied research that uses the theoretical reference of satisfaction of the work in the nursing of Mirlene Maria Matias Siqueira, and a methodology of software development of Viviane Bernardo. The objective was to develop a multimedia project (software) to evaluate satisfaction in nursing work. This research took place in two phases: construction of the multimedia project and its validity. In the construction phase of the project the following steps were followed: definition of the scope, planning and production. In the validation phase of the appearance and content of the software, they were carried out as validations of the project regarding: appearance; to content; usability; and acceptability. As an evaluation by the Judges Committee specialists in the subject. For evaluation of ergonomics and usability, the software was evaluated by 3 specialists in the area of Information Technology. For evaluation of content and appearance, the software was evaluated by 3 Nursing teachers. After the validations of specialists, the test was performed. Eleven workers from the nursing team participated. At the end of this research, the product was developed for a software for the Evaluation of Satisfaction in the Work of Nursing, entitled "WorkSatisfaction". Finally, we conclude the construction and validation process carried out in the study can contribute to the advancement of the use of non-teaching technology, research and practice in health and nursing

Construção e validação de um software para avaliação da satisfação no trabalho da enfermagem / Construction and validity of software to evaluate Nursing Work Satisfaction

A satisfação no trabalho pode ser caracterizada como o resultado positivo (prazeroso) das relações sociais e experiências vividas pelos trabalhadores no ambiente de trabalho. Ela se é subjetiva e se relaciona intrinsecamente com os vínculos afetivos diversos que permeiam as relações e sensações humanas que se apresentam além dos espaços físicos das instituições de trabalho. Ao longo do tempo, a satisfação tem se mostrado como fator contribuinte para a permanência dos indivíduos nas organizações e como fonte geradora de saúde e bem-estar no trabalho. Nesse contexto, o uso inovador da tecnologia em saúde pode determinar avanços relacionados à qualidade do cuidado e à melhoria da qualidade de vida das pessoas. Considerando a possibilidade de avanço científico na enfermagem por meio do uso de tecnologias informatizadas, buscou-se desenvolver este estudo no intuito de desenvolver um software para avaliar a satisfação no trabalho da enfermagem. Trata-se de uma pesquisa aplicada que utilizou o referencial teórico da satisfação do trabalho na enfermagem de Mirlene Maria Matias Siqueira, e a metodologia de desenvolvimento de software de Viviane Bernardo. Como objetivo, buscou-se o desenvolvimento de um projeto de multimídia (software) para avaliação da satisfação no trabalho da enfermagem. Esta pesquisa ocorreu em duas fases: construção do projeto de multimídia e sua validação. Na fase de construção do projeto seguiu-se as seguintes etapas: definição do escopo, planejamento e produção. Na fase de validação de aparência e de conteúdo do software, foram realizadas as validações do projeto quanto: à aparência; ao conteúdo; à usabilidade; e à aceitabilidade. As avaliações foram feitas por um Comitê de Juízes especialistas na temática. Para avaliação de ergonomia e usabilidade, o software foi avaliado por 3 especialistas da área de Tecnologia da Informação. Para avaliação de conteúdo e aparência, o software foi avaliado por 3 docentes de Enfermagem. Após as validações de especialistas, houve ajustes na ferramenta e posteriormente teste de aceitabilidade foi realizado. Participaram 11 trabalhadores da equipe de enfermagem. Ao final desta pesquisa o produto desenvolvido foi um software destinado à Avaliação da Satisfação no Trabalho da Enfermagem, intitulado "WorkSatisfaction". Por fim, concluímos que o processo de construção e validação realizado neste estudo pode contribuir para o avanço do uso da tecnologia no ensino, na pesquisa e na prática em saúde e enfermagem

Job satisfaction can be characterized as the positive (pleasurable) outcome of social relationships and experiences lived by workers in the work environment. It is subjective and intrinsically related to the diverse affective bonds that permeate human relations and sensations that are welcomed by the physical banks of the work institutions. Over time, a satisfaction has been announced as a contributor to a permanence of law in organizations and as a source of health and well-being without work. In this context, the innovative use of health technology can determine advances related to the quality of care and the improvement of people's quality of life. No method was found to evaluate a study to evaluate the research without nursing work. This is an applied research that uses the theoretical reference of satisfaction of the work in the nursing of Mirlene Maria Matias Siqueira, and a methodology of software development of Viviane Bernardo. The objective was to develop a multimedia project (software) to evaluate satisfaction in nursing work. This research took place in two phases: construction of the multimedia project and its validity. In the construction phase of the project the following steps were followed: definition of the scope, planning and production. In the validation phase of the appearance and content of the software, they were carried out as validations of the project regarding: appearance; to content; usability; and acceptability. As an evaluation by the Judges Committee specialists in the subject. For evaluation of ergonomics and usability, the software was evaluated by 3 specialists in the area of Information Technology. For evaluation of content and appearance, the software was evaluated by 3 Nursing teachers. After the validations of specialists, the test was performed. Eleven workers from the nursing team participated. At the end of this research, the product was developed for a software for the Evaluation of Satisfaction in the Work of Nursing, entitled "WorkSatisfaction". Finally, we conclude the construction and validation process carried out in the study can contribute to the advancement of the use of non-teaching technology, research and practice in health and nursing

Surface Length 3D: Plugin do OsiriX para cálculo da distância em superfícies / Surface Length 3D: An OsiriX plugin for measuring length over surfaces

Resumo Softwares tradicionais de avaliação de imagens médicas, como DICOM, possuem diversas ferramentas para mensuração de distância, área e volume. Nenhuma delas permite medir distâncias entre pontos em superfícies. O menor trajeto entre pontos possibilita o cálculo entre óstios de vasos, como no caso de aneurismas aórticos, e a avaliação dos vasos viscerais para planejamento cirúrgico. O desenvolvimento de um plugin para OsiriX para mensuração de distâncias em superfícies mostrou-se factível. A validação da ferramenta ainda se faz necessária.

Abstract Traditional DICOM medical imaging software offers several tools for measuring distance, area and volume. None allow measurement of distances between points along surfaces. The shortest path between points makes it possible to calculate distances between the ostia of vessels, useful in cases of aortic aneurysms and for assessment of visceral vessels for surgical planning. Developing a plugin for OsiriX for measurement of distances along surfaces proved to be achievable. The tool still needs to be validated.

Validation of JCountPro software for efficient assessment of ionizing radiation-induced foci in human lymphocytes.

PURPOSE: Ionizing radiation-induced foci (IRIF) known also as DNA repair foci represent the most sensitive and specific assay for assessing DNA double-strand break (DSB). IRIF are usually visualized and enumerated with the aid of fluorescence microscopy using antibodies to phosphorylated γH2AX and 53BP1. Although several approaches and software packages were developed for quantification of IRIF, not one of them was commonly accepted and inter-laboratory variability in the outputs was reported. In this study, JCountPro software was validated for IRIF enumeration in two independent laboratories. MATERIALS AND METHODS: Human lymphocytes were γ-irradiated at doses of 0, 2, 5, 10 and 50 cGy. The cells were fixed, permeabilized and IRIF were immunostained using appropriate antibodies. Cell images were acquired with automatic Metafer system. Endogenous and radiation-induced γH2AX and 53BP1 foci were enumerated using JCountPro. This analysis was performed from the same cell galleries by the researchers from two laboratories. Yield of foci was analyzed by either arithmetic mean (AM) value (foci/cell) or principal average (PA) derived from the approximation of foci distribution with Poisson statistics. Statistical analysis was performed using factorial ANOVA. RESULTS: Enumeration of 53BP1, γH2AX and co-localized 53BP1/γH2AX foci by JCountPro was essentially the same between laboratories. IRIF were detected at all doses and linear dose response was obtained in the studied dose range. PA values from Poisson distribution fitted the data better as compared to AM values and were more powerful and sensitive for IRIF analysis than the AM values. All JCountPro data were confirmed by visual focus enumeration. CONCLUSIONS: We concluded that the JCountPro software was efficient in objectively enumerating IRIF regardless of an individual researcher's bias and has a potential for usage in clinics and molecular epidemiology.

Use of softwares for posture assessment: integrative review / O uso de softwares para avaliação postural: revisão integrativa / Uso de softwares para la evaluación postural: revisión integradora

To carry out an integrative literature review on the postural analysis softwares available today. It is an integrative-narrative review of qualitative and methodological nature performed during April-July 2014. As inclusion criteria, the articles should be bibliographical or original research and available with full access. At first, we proceeded to the identification of the keywords for the softwares related to postural assessment commonly used in the health field, in such case "posture", "software", and "postural assessment". The search was narrowed by publication date from 2002 to 2014. Through the information acquired from the articles and from the software developers, information on 12 programs that assist the postural evaluation were obtained - Alcimage, All Body Scan 3D, Aplob, APPID, Biotonix, Corporis Pro, Fisimetrix, Fisiometer Posturograma, Physical Fisio, Physio Easy, Posture Print and SAPO. However, only one tool has more information and studies, namely SAPO. There are many postural analysis softwares available on the internet today, however, these are quite disparate in relation to possible answers and are still poorly widespread as research tools.

Realizar uma revisão integrativa da literatura sobre os softwares de análise postural disponíveis na atualidade. Trata-se de uma revisão integrativa-narrativa, de cunho metodológico e natureza qualitativa, realizada no período de abril a julho de 2014. Como critérios de inclusão, os artigos deveriam ser de natureza bibliográfica ou de pesquisa original e disponibilizados com acesso completo. A princípio, realizou-se a identificação de descritores relativos aos softwares relacionados à avaliação postural comumente utilizados no âmbito da saúde; sendo assim, os descritores foram "postura", "software" e "avaliação postural". As buscas foram estreitadas por data de publicação de 2002 a 2014. Diante das informações adquiridas a partir dos artigos e informações fornecidas pelos desenvolvedores dos softwares, foram obtidas informações sobre 12 programas que auxiliam a avaliação postural - Alcimage, All Body Scan 3D, Aplob, APPID, Biotonix, Corporis Pro, Fisimetrix, Fisiometer Posturograma, Physical Fisio, Physio Easy, Posture Print e SAPO. Entretanto, apenas uma ferramenta possui maior quantidade de informação e estudos realizados, o SAPO. Muitos são os softwares de análise postural disponíveis na internet atualmente, porém, são bastante díspares com relação às possibilidades de resposta e ainda são pouco difundidos como ferramentas de pesquisa.

Realizar una revisión integradora de la literatura sobre los softwares de análisis postural disponibles en la actualidad. Se trata de una revisión integradora-narrativa de carácter cualitativo y metodológico llevada a cabo durante abril y julio 2014. Como criterios de inclusión, los artículos debieran ser de naturaleza bibliográfica o de investigación original y disponibles con acceso completo. En un primer momento, se realizó la identificación de los descriptores para los softwares relacionados con la evaluación postural comúnmente utilizados en el campo de la salud, por lo tanto, los descriptores fueron "postura", "software" y "evaluación postural." La búsqueda se redujo por fecha de publicación, de 2002 a 2014. Teniendo en cuenta la información obtenida de los artículos y proporcionada por los desarrolladores de software, se obtuvieron informaciones sobre 12 programas que auxilian la evaluación postural - Alcimage, All Body Scan 3D, Aplob, APPID, Biotonix, Corporis Pro, Fisimetrix, Fisiometer Posturograma, Physical Fisio, Physio Easy, Posture Print y SAPO. Sin embargo, sólo una herramienta cuenta con toda la información y los estudios, a saber, SAPO. Hay muchos softwares de análisis postural disponibles en Internet actualmente, aunque sean bastante disímiles en relación a las posibles respuestas y todavía no se hayan difundido como herramientas de investigación.

Integrating Methods to Evaluate Health Information Systems.

There are different methods to evaluate Health Information Systems (HIS), such as Quality Evaluation of software products, human factors, and socio-technical approaches. This work aims to identify the main aspects used to evaluate HIS, and whether there are relationships between issues considered in assessment of software quality and the ones applied specific to the health domain. This was an exploratory study that included a literature search related to HIS evaluation and software quality analyses applying the norms of the International Organization for Standardization (ISO/IEC), to identify aspects and features applied during the assessment process. The result is a proposal of an evaluation method based on the integration of these two evaluative approaches, combining or complementing the considered aspects. The method was applied to an evaluation of a natural language processing system to identify continuity of care in discharge summaries.