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1.
Rev. bras. cir. cardiovasc ; 37(2): 207-211, Apr. 2022. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1376524

ABSTRACT

Abstract Introduction: This study examines early- and long-term outcomes of mitral valve repairs in a low-volume cardiac surgery centre in the Caribbean. Methods: Ninety-six consecutive patients underwent mitral valve repair from April 2009 to December 2018. Patients were divided into two groups: functional mitral regurgitation requiring simple mitral annuloplasty (FMR, n=63) or structural degenerative mitral regurgitation requiring more complex repair (DMR, n=33). Data collected prospectively were retrospectively analysed from the unit-maintained cardiac surgery database. Results: Thirty-day mortality in the whole series was 2.1%, with 3% in the FMR group and 0% in the DMR group. Early post-operative echocardiography in the FMR group demonstrated 51 patients (83.6%) without mitral regurgitation, 8 patients (13.1%) with trivial to mild regurgitation, and 2 patients (3.3%) with moderate regurgitation. However, at a mean follow-up of 98.2±50.8, only 21 patients (42.8%) were in NYHA class I, with 7 (14.2%) in class II, 16 (32.6%) in class III, and 5 (10.2%) in class IV. There were 9 cardiac-related deaths at final follow-up, with freedom from re-operation and survival of 98% and 75.6%, respectively. In the DMR group, early post-operative echocardiography demonstrated 29 patients (87.9%) without mitral regurgitation, 3 patients (9.1%) with trivial regurgitation and 1 patient (3.0%) with mild regurgitation. At a mean follow-up of 114.1±25.4 months, there was a good functional post-operative status in this group with 93.3% in NYHA class I, and 6.7% in class II. No patient required reintervention, 96.3% of patients had mild or no mitral regurgitation and survival was 90.9%. Conclusion: Despite challenges of maintaining skills in a low-volume centre, mitral valve repair can be performed safely with good early- and long-term results.

2.
Säo Paulo med. j ; 140(2): 290-296, Jan.-Feb. 2022. tab, graf
Article in English | LILACS | ID: biblio-1366045

ABSTRACT

ABSTRACT BACKGROUND: Multiple opinion-based communications have highlighted the actions of the Brazilian government during the pandemic. Nevertheless, none have appraised public data to identify factors associated with worsening of the healthcare system. OBJECTIVE: To analyze and collate data from public health and treasury information systems in order to understand the escalating process of weakening of Brazilian healthcare and welfare since the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. DESIGN AND SETTING: Secondary data study conducted using multiple public databases administered by the Brazilian federal government. METHODS: We processed information from multiple national databases and appraised health and economic-related data. RESULTS: Based on our analyses, there were substantial reductions in inpatient hospital admissions and in the numbers of patients seeking primary care services, along with a decrease in immunization coverage. Moreover, we observed a considerable decline in government transfers to hospital services (reduction of 82.0%) and a diminution of public outlays in several healthcare-related subfunctions ("hospital and outpatient care", "primary care", "prophylactic and therapeutic support" and "epidemiological surveillance"). We observed an increase in the overall mortality rate over the period analyzed, especially regarding all group-based diseases. Notably, there were remarkable differences among geographic, racial, gender and other parameters, thus revealing the impact of vulnerabilities on COVID-19 outcomes. CONCLUSION: This assessment of documentation of public expenditure and the shrinkage of investment in sensitive areas of the healthcare system in Brazil emphasized areas that still require collective attention in order to guarantee national welfare.


Subject(s)
COVID-19 , Brazil/epidemiology , Health Expenditures , SARS-CoV-2 , Hospitalization
3.
Article in Chinese | WPRIM | ID: wpr-934554

ABSTRACT

Cost data caliber governance is key to fine cost management. To tackle the troubles in cost data management at multiple campuses of one hospital, the authors built a multi-campus cost data caliber governance mode. By means of enhanced top-level design, the mode carried out data governance by such measures as the establishment of data dictionary mapping library, standardizing department names and caliber, classification of charging items of medical services, precisely matching between fixed assets and charging items, interconnecting the management system of charging library and the procurement library of consumables, as well as precisely matching surgical disease types and charging items. These measures accomplished the consistency and comparability of cost data across campuses, building an automated, streamlined, standardized and integrated data governance mode for reference of hospitals with multiple campuses in need of cost management.

4.
Rio de Janeiro; s.n; 2022. 85 f p. tab, graf, il.
Thesis in Portuguese | LILACS | ID: biblio-1390609

ABSTRACT

Este estudo aborda o tema de sistemas de informação utilizados na gestão de recursos humanos em saúde na Secretaria de Estado de Saúde do Rio de Janeiro (SES/RJ), órgão da Administração Direta do Poder Executivo do Estado. A SES/RJ é responsável por definir políticas de saúde no Estado, a qual utiliza vários sistemas de informação para gestão de sua força de trabalho, com evidências de fragmentação dos dados, dificuldade na gestão das informações e prejuízo na definição de estratégias. Nesse sentido, este trabalho tem como objetivo descrever os sistemas de informação de recursos humanos em uso na SES/RJ, no contexto dos modelos de gestão adotados em suas unidades de saúde, e contribuir para melhorar a gestão de recursos humanos e das informações geradas no âmbito da instituição, fornecendo subsídios para o processo de tomada de decisão. Para tanto, fez-se, primeiramente, uma revisão bibliográfica sobre o tema desde o ano de 1995, período da Reforma do Estado, e uma pesquisa documental em portais e legislações, tanto da SES/RJ como de outros órgãos estaduais, assim como das esferas federal e municipal. Em seguida, o trabalho discute as possibilidades e os subsídios que possam favorecer a interoperabilidade desses sistemas e, assim, facilitar a gestão da força de trabalho na instituição.


This study investigates the use of information systems in the administration of human resources in health at the Rio de Janeiro State Department of Health (SES/RJ), which is part of the Direct Administration of the State Government. SES/RJ oversees establishing state health policies and managing its staff using a variety of information systems, with evidence of data fragmentation, information management challenges, and strategy development impairment. In this sense, this study aims to describe the human resources information systems in use at SES/RJ in relation to the management models used in its health units, as well as to contribute to improving human resources management and the information generated within the institution by providing decision-making inputs. To that end, we conducted a bibliographic review of the topic dating back to 1995, during the State Reform period, as well as document search in the portals and legislation of SES/RJ and other state agencies, as well as federal and municipal domains. The study then moves on to the possibilities and advantages that may encourage system interoperability and, as a result, make labor management in the institution easier.


Subject(s)
Personnel Management , Information Systems , Public Health , Electronic Health Records , Health Workforce , Brazil
5.
Rev. chil. enferm. respir ; 37(4): 293-302, dic. 2021. ilus, tab
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1388164

ABSTRACT

INTRODUCCIÓN: La Fibrosis Pulmonar Idiopática (FPI) es una de las enfermedades respiratorias crónicas del adulto de mayor impacto y letalidad, diversos estudios epidemiológicos muestran tendencias progresivas al aumento de las tasas de mortalidad por FPI. En Chile no existen reportes sobre las tendencias de las tasas de mortalidad por FPI. El objetivo del presente estudio es determinar las tendencias de la mortalidad por FPI en Chile entre los años 2002 y 2015. MÉTODO: Estudio descriptivo de diseño ecológico, a partir de la información de bases de datos secundarias de libre disposición de las estadísticas vitales del Departamento de Estadísticas e Información de Salud (DEIS) y del Instituto Nacional de Estadísticas (INE) de Ministerio de Salud de Chile entre los años 2002 y 2015 se obtuvieron las tasas crudas de mortalidad por fibrosis pulmonar idiopática en población de 45 años y más en ambos sexos y las tasas ajustadas por sexo y edad por regiones, se calculó también la frecuencia mensual de las muertes por FPI y se compararon las tasas medias de mortalidad por regiones. RESULTADOS: Se observó un incremento progresivo de la tasa nacional cruda de mortalidad por FPI entre los años 2002 a 2015, la que fue de 18,5 fallecidos por 100.000 habitantes en el año 2002 hasta 24,6 fallecidos por 100.000 habitantes en el año 2015 con una pendiente de ascenso por año de +0,27 por 100.000 habitantes (p = 0,013). En las mujeres las tasas fueron más altas que en los hombres, pero las pendientes de ascenso no presentaron diferencias entre sexos. En la gran mayoría de las regiones las tasas ajustadas presentaron tendencias significativas al ascenso y las tasas medias más altas se presentaron en las regiones del norte de Chile. Se observó un comportamiento estacional de las muertes siendo las frecuencias más altas en los meses de invierno. CONCLUSIONES: Las tasas de mortalidad por FPI en Chile presentan una tendencia progresiva al aumento, con marcadas diferencias regionales lo que lleva a considerar, entre otros factores, influencia ambiental y contaminación del aire y de suelos que se debieran investigar para poder realizar intervenciones de salud pública que permitan reducir la mortalidad de esta enfermedad en nuestro país.


BACKGROUND: Idiopathic Pulmonary Fibrosis (IPF) is one of the chronic respiratory diseases in adults with the greatest impact and high case fatality rate. Various epidemiological studies show progressive trends towards increasing IPF mortality rates. In Chile there are no national reports on country and regional trends in IPF mortality rates. The objective of this study is to determine trends in mortality due to IPF in Chile from year 2002 to 2015. METHOD: Epidemiological study of ecological design based on information from public databases of vital statistics of the Department of Health Statistics and Information (DEIS) and the National Institute of Statistics (INE) of the Ministry of Health of Chile. Crude mortality rates due to IPF in the population aged 45 years and over in both sexes were obtained from years 2002 to 2015. Besides the adjusted mortality rates for sex and age by region, the monthly frequency of IPF deaths during the same period and the average mortality rates by Chilean regions were calculated. RESULTS: A progressive increasing trend in the crude national IPF mortality rate was observed between years 2002 to 2015, which went from 18.5 deaths per 100,000 inhabitants in 2002 to 24.6 deaths per 100,000 inhabitants in 2015 with a slope of ascent per year of +0.27 per 100,000 inhabitants (p = 0.013); female rates were higher than men rates, but without differences in the slopes between sexes; in the vast majority of the regions the rates showed significant upward trends with the higher ones in the northern regions of Chile. A seasonal behavior of the death's frequency was observed being the highest in the winter term. CONCLUSIONS: Mortality rates due to IPF in Chile show a progressive upward trend, with marked regional differences which leads to consider, among other factors, environmental influence and air and soil contamination that should be investigated to carry out public health interventions that allow reducing the mortality of this disease in our country.


Subject(s)
Male , Female , Middle Aged , Aged , Aged, 80 and over , Idiopathic Pulmonary Fibrosis/mortality , Seasons , Chile/epidemiology , Epidemiology, Descriptive , Vital Statistics , Mortality/trends , Sex Distribution , Ecological Studies
6.
RECIIS (Online) ; 15(3): 722-735, jul.-set. 2021. ilus, tab
Article in English | LILACS | ID: biblio-1342698

ABSTRACT

The FAIR principles have become a data management instrument for the academic and scientific community, since they provide a set of guiding principles to bring findability, accessibility, interoperability and reusability to data and metadata stewardship. Since their official publication in 2016 by Scientific Data ­ Nature, these principles have received worldwide recognition and have been quickly endorsed and adopted as a cornerstone of data stewardship and research policy. However, when put into practice, they occasionally result in organisational, legal and technological challenges that can lead to doubts and uncertainty as to whether the effort of implementing them is worthwhile. Soon after their publication, the European Commission and other funding agencies started to require that project proposals include a Data Management Plan (DMP) based on the FAIR principles. This paper reports on the adherence of DMPs to the FAIR principles, critically evaluating ten European DMP templates. We observed that the current FAIRness of most of these DMPs is only partly satisfactory, in that they address data best practices, findability, accessibility and sometimes preservation, but pay much less attention to metadata and interoperability.


Os princípios FAIR tornaram-se um instrumento de gestão de dados para a comunidade acadêmica e científica, uma vez que fornecem um conjunto de princípios orientadores que facilitam a localização, acessibilidade, interoperabilidade e reutilização de dados e metadados. Desde sua publicação oficial em 2016 pela Scientific Data - Nature, esses princípios receberam reconhecimento mundial e foram rapidamente endossados e adotados como pilares da gestão de dados e das políticas de pesquisa. No entanto, quando postos em prática, apresentam ocasionalmente desafios organizacionais, jurídicos e tecnológicos que podem levar a dúvidas e incertezas quanto ao esforço em implementá-los. Logo após sua publicação, a Comissão Europeia e outras agências de financiamento começaram a exigir nas suas propostas de projetos um Plano de Gestão de Dados (PGD) com base nos princípios da FAIR. Este artigo relata a aderência dos PGDs aos princípios FAIR, avaliando criticamente dez modelos europeus de PGD. Observamos que o nível de FAIRness da maioria dos PGDs analisados ainda é parcialmente satisfatório, uma vez que abordam as melhores práticas de dados, localização, acessibilidade e, às vezes, preservação, mas dão pouca atenção aos metadados e a interoperabilidade.


Los principios FAIR se han convertido en una herramienta de gestión de datos para la comunidad académica y científica, ya que proporcionan un conjunto de principios rectores que facilitan la localización, accesibilidad, interoperabilidad y reutilización de la gestión de datos y metadatos. Desde su publicación oficial en 2016 por Scientific Data - Nature, estos principios han recibido reconocimiento mundial y fueron rápidamente respaldados y adoptados como pilares de la política de investigación y gestión de datos. Sin embargo, cuando se ponen en práctica, ocasionalmente presentan desafíos organizativos, legales y tecnológicos que pueden generar dudas e incertidumbres sobre el esfuerzo para implementarlos. Poco después de su publicación, la Comisión Europea y otras agencias de financiación comenzaron a exigir en sus propuestas de proyectos un Plan de Gestión de Datos (PGD) basado en los principios de FAIR. Este artículo informa sobre la adherencia de los PGD a los principios FAIR, evaluando críticamente diez modelos europeos de PGD. Observamos que el nivel de FAIRness de la mayoría de los PGD analizados sigue siendo parcialmente insatisfactorio, ya que abordan las mejores prácticas de datos, ubicación, accesibilidad y, a veces, preservación, pero prestan poca atención a los metadatos y la interoperabilidad.


Subject(s)
Humans , Metadata , Scholarly Communication , Health Information Interoperability , Data Management , Comment , Health Research Policy , Scientific Domains , Data Analysis
7.
Rev. chil. enferm. respir ; 37(3): 222-229, sept. 2021.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1388150

ABSTRACT

INTRODUCCIÓN: A pesar del progreso de la investigación mundial sobre el comportamiento sedentario, sabemos poco aún acerca de sus relaciones y efectos en la población con enfermedad pulmonar obstructiva crónica (EPOC), por eso el objetivo de esta revisión fue analizar la evidencia actual y más frecuente disponible sobre este tema. MÉTODO: Se utilizaron cinco bases de datos electrónicas para realizar una revisión cualitativa diagnóstica. Los documentos elegibles de los últimos cinco años se analizaron descriptivamente en una tabla de extracción de datos y analizaron por separados los distintos temas encontrados. RESULTADOS: Se evidenció en varios artículos el alto comportamiento sedentario en EPOC, y cómo se relaciona con el nivel de severidad de la enfermedad y con mortalidad. La estrategia principal sugerida fue reemplazar el tiempo sedente con actividad física. Discusión: Los resultados de la revisión son similares a lo estudiado en población de variada comorbilidad. Sin embargo, los precedentes de éstos son más específicos en cuanto a recomendaciones. Deben tomarse en cuenta aquellos hallazgos previos como directriz de estudio en la EPOC, ya que se comparte la base fisiopatológica de inflamación crónica sistémica. CONCLUSIÓN: Algunos hallazgos encontrados con mayor frecuencia, son la relación del comportamiento sedentario con la mortalidad y el desarrollo de mayor comorbilidad en la EPOC, además de la intervención a través de la actividad física, por lo cual es necesario profundizar en esta temática buscando estrategias y recomendaciones específicas para esta población.


INTRODUCTION: Despite the progress of global research on sedentary behavior, we know little about its relationships and its effects on the population with chronic obstructive pulmonary disease (COPD). therefore, the purpose of this review was to analyze the current and most common evidence available on these issues. METHOD: Five electronic databases were used to conduct a qualitative diagnostic review. eligible documents from the past five years were descriptively analyzed in a data extraction table and analyzed separately the various topics found. RESULTS: High sedentary behavior in COPD was evident in several articles, and how it relates to the severity level of the disease and mortality. the main suggested strategy was to replace sedentary time with physical activity. Discussion: The results of this review are similar to what is studied in a population of varied co-morbility. However, their precedents are more specific in terms of recommendations. previous findings should be considered as a study guideline in COPD, as the pathological basis of chronic systemic inflammation is shared. CONCLUSION: Some findings found more frequently are the relationship of sedentary behavior with mortality and the development of greater co-morbility in COPD, in addition to intervention through physical activity, so it is necessary to deepen this topic by looking for strategies and recommendations specific to this population.


Subject(s)
Humans , Pulmonary Disease, Chronic Obstructive/epidemiology , Sedentary Behavior , Exercise , Pulmonary Disease, Chronic Obstructive/therapy
8.
Rev. bras. cir. cardiovasc ; 36(4): 550-556, July-Aug. 2021. tab, graf
Article in English | LILACS | ID: biblio-1347152

ABSTRACT

Abstract Introduction: In high-volume trauma centers, especially in developing countries, penetrating cardiac box injuries are frequent. Although many aspects of penetrating chest injuries have been well established, video-assisted thoracoscopy is still finding its place in cardiac box trauma and algorithmic approaches are still lacking. The purpose of this manuscript is to provide a streamlined recommendation for penetrating cardiac box injury in stable patients. Methods: Literature review was carried out using PubMed/MEDLINE and Google Scholar databases to identify articles describing the characteristics and concepts of penetrating cardiac box trauma, including the characteristics of tamponade, cardiac ultrasound, indications and techniques of pericardial windows and, especially, the role of video-assisted thoracoscopy in stable patients. Results: Penetrating cardiac box injuries, whether by stab or gunshot wounds, require rapid surgical consultation. Unstable patients require immediate open surgery, however, determining which stable patients should be taken to thoracoscopic surgery is still controversial. Here, the classification of penetrating cardiac box injury used in Colombia is detailed, as well as the algorithmic approach to these types of trauma. Conclusion: Although open surgery is mandatory in unstable patients with penetrating cardiac box injuries, a more conservative and minimally invasive approach may be undertaken in stable patients. As rapid decision-making is critical in the trauma bay, surgeons working in high-volume trauma centers should expose themselves to thoracoscopy and always consider this possibility in the setting of penetrating cardiac box injuries in stable patients, always in the context of an experienced trauma team.


Subject(s)
Humans , Thoracic Injuries , Wounds, Gunshot , Wounds, Penetrating , Heart Injuries/surgery , Heart Injuries/diagnostic imaging , Thoracoscopy , Thoracic Surgery, Video-Assisted
9.
Rev. bras. cir. cardiovasc ; 36(1): 78-85, Jan.-Feb. 2021. tab, graf
Article in English | LILACS | ID: biblio-1155798

ABSTRACT

Abstract Introduction: The benefit of total arterial revascularization (TAR) in coronary artery bypass grafting (CABG) remains a controversial issue. This study sought to evaluate whether there is any difference on the long-term results of TAR and non-TAR CABG patients. Methods: The Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica dataBASE (EMBASE), Cochrane Central Register of Controlled Trials (CENTRAL/CCTR), Clinical Trials.gov, Scientific Electronic Library Online (SciELO), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), and Google Scholar databases were searched for studies published by October 2020. Randomized clinical trials and observational studies with propensity score matching comparing TAR versus non-TAR CABG were included. Random-effects meta-analysis was performed. The current barriers to implementation of TAR in clinical practice and measures that can be used to optimize outcomes were reviewed. Results: Fourteen publications (from 2012 to 2020) involving a total of 22,746 patients (TAR: 8,941 patients; non-TAR: 13,805 patients) were included. The pooled hazard ratio (HR) for long-term mortality (over 10 years) was lower in the TAR group than in the non-TAR group (random effect model: HR 0.676, 95% confidence interval 0.586-0.779, P<0.001). There was evidence of low heterogeneity of treatment effect among the studies for mortality, and none of the studies had a particular impact on the summary result. The result was not influenced by age, sex, or comorbidities. We identified low risk of publication bias related to this outcome. Conclusion: This review found that TAR presents the best long-term results in patients who undergo CABG. Given that many patients are likely to benefit from TAR, its use should be encouraged.


Subject(s)
Humans , Coronary Artery Disease/surgery , Percutaneous Coronary Intervention , Coronary Artery Bypass , Treatment Outcome , Propensity Score
10.
Article in Chinese | WPRIM | ID: wpr-912844

ABSTRACT

Clinical data is one of the key sources of real-world data, while the reliability of such data is often hindered by unscientific and irregular data management. Based on various problems found in the application of clinical data to scientific research, this study formulated a standard operation procedure(SOP) for real-world data management, and organized the data in terms of content and logic consistency, completeness and standardization. The clinical data of syphilis at a tertiary hospital were used as an example for verification. The clinical data of syphilis patients in the dermatology department from January 1, 2008 to January 1, 2018 were derived from the basic information database, diagnosis database, laboratory information database, and treatment information database of its hospital information system, and a total of 71 705 pieces of relevant information were extracted. SOP analysis showed that 6 816 articles were completely repeated. There were content or logical inconsistencies in name, medical identification number, resident ID number, age and gender, being 152, 360, 88, 107 and 457 respectively. There were many missing entries for marital status, ethnicity, gender, birthday, and ID number, being 1 711, 1 077, 457, 496 and 355 respectively. The standardization situation was generally good, and the number of irregularities in filling out occupational items was 1 884. The standardized and collated data could effectively count the proportion of patients in different stages of syphilis and the cost of diagnosis and treatment, indicating that the real-world data management and analysis SOP proposed in this study could be used to build a clinical-research oriented dual-functional database based on medical practice data.

11.
Article in Chinese | WPRIM | ID: wpr-912586

ABSTRACT

Objective:To summarize the experiences of clinical study project management in Peking University Clinical Research Institute, REDCap (Research Electronic Data Capture) data management system was proposed to improve the follow-up process management.Methods:Current clinical study follow-up process management situation were analyzed and methods for utilizing REDCap in follow-up management was proposed.Results:Using REDCap through " direct management" and " system management" data management can improve the follow-up quality and standard level of management in clinical study, at the same time, secured better protection of participants′ privacy and rights during the process.Conclusions:REDCap plays crucial roles in securing follow-up data quality from the source, timely tracking and standardization of follow-up management, it can be adopted more widely in assisting clinical study follow-up management.

12.
Rev. cuba. inform. méd ; 12(2): e381, tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1144468

ABSTRACT

Introducción: El Centro Nacional Coordinador de Ensayos Clínicos (CENCEC) utiliza el software OpenClinica para diseñar los Cuadernos de Recogida de Datos (CRD) de los ensayos clínicos. Cada ensayo tiene características específicas, pero existen datos comunes a todos los ensayos que pueden ser estandarizados. Objetivo: Desarrollar una biblioteca de plantillas para el diseño de los CRD. Método: Se realizó un análisis documental de los estándares para el manejo de datos en los ensayos clínicos y se analizaron los diseños utilizados en cuatro ensayos desarrollados en OpenClinica. Resultados: Según los tipos de datos que se registran en los ensayos clínicos se diseñaron 14 plantillas. Cada plantilla, es un fichero Excel con cinco hojas de trabajo donde se registran todas las definiciones del CRD. Las plantillas se han utilizado en tres ensayos clínicos con resultados favorables. Conclusión: Las 14 plantillas que componen la biblioteca CRD fueron diseñadas permitiendo su futura reutilización en la gestión de datos de nuevos ensayos clínicos(AU)


Introduction: CENCEC uses OpenClinica software to design the database of the Case Report Forms (CRF) of the clinical trials (CT). Every trial has specific characteristics although some of them are common to all trials which permit to standardize the process. Objective: To develop a library of templates in order to design the CRF. Methods: A documentary analyses of the standards for data management in clinical trials was performed and in addition of that four designs developed at OpenClinica were reviewed. Results: A library of 14 templates according to data types of CT was proposed. Every template is an Excel file with five sheets in which the definitions of the CRF is registered. The templates have been used in three CT. Conclusions: The 14 templates that make up the CRF library were designed allowing their future reuse in the management of data from new clinical trials(AU)


Subject(s)
Humans , Software Design , Software , Clinical Trials as Topic , Data Management
13.
An. Fac. Cienc. Méd. (Asunción) ; 53(1): 17-30, 20200401.
Article in English | LILACS | ID: biblio-1095632

ABSTRACT

Actualmente, la gestión de datos en el departamento de oncología es compleja y requiere sistemas de información avanzados para procesar datos donde la información "ómica" debe integrarse junto con los datos clínicos del paciente para mejorar el análisis de datos y el proceso de toma de decisiones. Este trabajo de investigación presenta una experiencia práctica en este contexto. Se ha diseñado un Modelo Conceptual (MC) para desarrollar un Sistema de Información (SI) con el fin de gestionar datos clínicos, patológicos y moleculares de manera integral en el departamento de oncología de dos hospitales principales en Paraguay. Además, se han propuesto arquetipos basados en modelos para especificar la estrategia de interacción del usuario. El MC y los arquetipos asociados son la base para desarrollar un SI clínico con el fin de cargar -primero- y gestionar -segundo- todos los datos clínicos que requiere el dominio, mostrando cuán factible es el enfoque en la práctica y cuánto se mejora la gestión de datos. En este trabajo, queremos reforzar con esta experiencia real, cómo el uso correcto de un MC junto con los arquetipos ayuda a diseñar, desarrollar y administrar mejores sistemas de información, enfatizando la relevancia del dominio clínico seleccionado.


Currently, data management in oncology department is complex and requires advanced Information Systems (ISs) to process data where "omic" information should be integrated together with patient's clinical data to improve data analysis and decision-making process. This research paper reports a practical experience in this context. A Conceptual Model (CM) has been designed to develop an Information System (IS) in order to manage clinical, pathological, and molecular data in a holistic way at the oncology department of two main Hospitals in Paraguay. Additionally, model-based archetypes have been proposed to specify the selected user interaction strategy. The CM and its associated archetypes are the basis to develop a clinical IS in order to load -firstly- and manage -secondly- all the clinical data that the domain requires, showing how feasible the approach is in practice, and how much the corresponding clinical data management is improved. In this work, we want to reinforce with this real experience how using a CM along with archetypes correctly helps to design, develop and manage better information systems, emphasizing the relevance of the selected clinical domain


Subject(s)
Electronic Health Records
14.
Article in Chinese | WPRIM | ID: wpr-843111

ABSTRACT

Objective: To introduce how to build a data platform of data collection and data management for multi-center birth cohort study by using REDCap. Methods: After the REDCap electronic data capture system was installed and set up, the electronic case report forms (eCRFs) were programmed to collect data in multi-centers. The rules of data quality control were programmed, and different levels of user right for access to data platform were assigned to the data managers and data clerks based on their role in research project. Results: With REDCap system being installed, the example project was created, and a series of eCRFs were established for each stage of preconception, pregnancy and childhood through follow-up. After intensive testing to improve and achieve a stable data platform, standardized trainings were provided to data-related team. The REDCap eCRFs were then put in use online. By assigning different user right of access to data platform, data entry can be from multi- research centers and survey sites. This REDCap data platform supported the cohort project on data collection and data management. Conclusion: The data platform established by using REDCap provides strong support to birth cohorts on data collection and data management. This example project of data platform can be applied to other epidemiological studies.

15.
Article in Chinese | WPRIM | ID: wpr-912550

ABSTRACT

Objective:To clarify the status of library service to the scientific research, and propose methods for providing library service to scientific research.Methods:We analyze the current situations and problems of library services to understand the needs of scientific research.Results:By integrating the service platform, data management, personal and intelligent services, the library has improved the service ability and level to scientific research and effectively assisted scientific research management.Conclusions:In the era of big data, libraries can make good use of information advantages to assist scientific research services and continuously develop new service models.

16.
Article in Chinese | WPRIM | ID: wpr-855837

ABSTRACT

Electronic data management has the advantages of saving cost and research time and improving the data quality, which has gradually been the mainstream form of clinical data collection and management. It is important to improve the quality of Traditional Chinese Medicine (TCM) clinical researches. This paper introduces the function, general style, developing principles and processes, management and training of Standard Operating Procedure (SOP) for electronic clinical data management. The characteristics and difficulties of electronic data management of TCM clinical researches are discussed and suggested solutions are proposed in the end.

17.
Article in Chinese | WPRIM | ID: wpr-855821

ABSTRACT

China has started to accept the overseas clinical trial data about drug and medical devices, and the data in accordance with the requirements can be used to register in China. To do this work well, we should consider four key dimensions: data acceptance principle, data quality and reliability, data evaluation usability and data international difference. Among them, the authenticity, integrity, accuracy and traceability of data are the main factors to determine the quality reliability of data. Receiving data from overseas clinical trials about drug and medical devices will be conducive to the establishment of international mutual recognition system for clinical trial data, and to enhance the importance of data management in domestic clinical trials, and to promote the formation of quality management system on clinical trial data.

18.
Article | IMSEAR | ID: sea-195818

ABSTRACT

The Indian Council of Medical Research, in 2013, initiated the Antimicrobial Resistance Surveillance & Research Network (AMRSN) to enable compilation of data on six pathogenic groups on antimicrobial resistance from the country. The overarching aim of this network was to understand the extent and pattern of antimicrobial resistance (AMR) and use this evidence to guide strategies to control the spread of AMR. This article describes the conception and implementation of this AMR surveillance network for India. Also described are the challenges, limitations and benefits of this approach. Data from the Network have shown increasing resistance in Gram-negative bacteria in the hospitals that are part of this network. Combined resistance to third-generation cephalosporins and fluoroquinolones and increasing carbapenem resistance are worrisome, as it has an important bearing on the patients' outcome and thus needs to be addressed urgently. Data generated through this Network have been used to develop treatment guidelines, which will be supportive in harmonizing treatment practices across the tertiary level healthcare institutions in the country. While, the major benefit of having a surveillance system is the collection of real-time accurate data on AMR including the mechanisms of resistance, representativeness to community, sustaining the current effort and expanding the current activities to next levels of healthcare settings are the major challenges. The data emanating from the network besides providing evidence, expose several gaps and lacunae in the ecosystem and highlight opportunities for action by multiple stakeholders.

19.
Article in Japanese | WPRIM | ID: wpr-758270

ABSTRACT

The fundamental issues which underlie research misconduct of Diovan case are 1)lack of data-quality control system managed by a competent data manager, 2)absence of trial statistician with sufficient knowledge of methodology (from all the aspects such as scientific, ethical and operating), 3)lack of standard operating procedures (SOPs) to secure blinding of assessors and independence of interim data analysis, which eventually allowed the investigators and statisticians to improperly check and edit crucial data in the midst of the trial. The Biometric Society of Japan, the community of Japanese biostatisticians, issued “The Biometric Society of Japan statement for clinical trials” , established “Statisticians standard of conducts” , and started the Accreditation for Trial Statistician from 2017. Many clinical trials sponsored by universities or research institutes (excluding investigator-initiated TIKEN) are not equipped with SOPs, adequate logistics, and clear responsibility. Moreover, a fair number of so-called “trial statisticians” only provide sample-size calculation and technical aspects of data analysis as statistical consultation. Academia should learn from Diovan case and pursue its role of educating creditable trial statisticians who bear social responsibility and establishing their social status.

20.
Article in Chinese | WPRIM | ID: wpr-800829

ABSTRACT

The application of a specialized imaging data management system in ophthalmology not only improves clinical diagnosis and treatment, but also brings change to the traditional teaching of ophthalmology. Department of Ophthalmology in Beijing Tongren Hospital Affiliated to Capital Medical University applied the FORUM (Carl Zeiss, FORUM V4.0, Germany) imaging data management system in clinical practice and postgraduate teaching of ophthalmology. The imaging data management system can obtain the primary imaging data of patients and the data can be accessed at any time, which brings great convenience for teachers to show the cases. The imaging data management system can help clinical teachers to improve the teaching effect of direct teaching and cultivate students' clinical thinking to carry out case discussion, and it can also help to cultivate scientific thinking of postgraduates.

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