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Pancreatic diseases is a kind of complex, high-risk gastrointestinal diseases. Pancreatic cancer is highly malignant and seriously endangers people′s health. Developing multi-center, large-scale real world research can better understand the incidence patterns and treatment outcomes of pancreatic diseases. Based on the multi-center and heterogeneous data, the authors for-mulate data standards for real world studies of pancreatic diseases, and build a database of pancreatic cancer, integrating and sharing data from multi-center sources, in order to fully explore the scientific research value of pancreatic cancer clinical information, and provide experience and reference for the construction of other real world research specific disease databases in the future.
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Asymptomatic spleen-stomach diseases refer to diseases without related symptoms and signs of abdo-minal pain， bloating， diarrhea an others in patients， but showing lesions or pathological changes discovered by modern medical techniques such as endoscopy， CT， MRI. The four examination techniques of traditional Chinese medicine （TCM） are based on symptoms and signs of patients， which are the advantage of TCM but also have certain limitations. In the context of the increasingly modernized diagnosis and treatment in TCM， it is proposed to expand the application of the four examination techniques from three aspects including microcosmic syndrome differentiation， data sharing， and artificial intelligence in asymptomatic spleen-stomach diseases， in order to achieve the goals of dynamically observing the disease process， collecting disease data in multiple dimensions， and intelligently processing disease data. This will strengthen the modern requirements of early diagnosis and treatment in TCM， and highlight the advantages of TCM in “treating disease before it arises and treating the symptoms beforehand”.
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In order to effectively integrate scientific research data resources and improve data utilization, the National Clinical Medical Research Center had built a "3321" -integration big data sharing innovation platform. By providing full support to scientific research, sorting out the distribution mechanism of achievements, and formulating authority management norms, the big data platform had solved the weaknesses in data sharing ability, sharing willingness, and sharing security, giving full play to the effectiveness of the clinical research big data platform. By February 2022, the center had collected more than 1.04 million elderly patients data through the big data platform, as well as carried out 75 scientific research projects, and established 10 large population-based clinical research queues. The big data platform had realized full coverage of major diseases in the field of geriatric diseases, promoted the high-quality construction of the national clinical medical research center, and improved the scientific research and innovation ability of the cooperative units.
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Objective:The paper aims to investigate the current situation and influencing factors of clinical research data sharing of gastroenterology collaboration network of Beijing municipal hospitals so as to provide reference basis for establishing data sharing mode of collaboration center.Methods:A total of 13 gastroenterology department of Beijing municipal hospital collaboration network units enrolled the research. Each department selected 10-15 clinicians for a questionnaire survey. A total of 157 valid questionnaires were collected.Results:The awareness rate of public data platform(realized at least one) is 81.5%. The rate of browsing public data platform is 65.6%. The rate of downloading and uploading rare data are 13.4% and 1.3%, respectively. As the level of professional titles increases, the proportion of clinicians realizing and downloading raw data has increased significantly( P<0.05). In this survey, 31.3% clinicians used the sharing data from other hospitals within the research group and 53.5% clinicians indicated that there is the data sharing platform based on hospital information system within their hospital/department. The rate of willing to share clinical data is 73.3%. However, a majority of clinicians are inclined to accept the sharing within the research group/hospital, and they prefer to share their data when their papers or research results are published. Data storage is mainly numerical and text structured data. Sharing risk, sharing platform, sharing system and data itself are the top four factors affecting data sharing. Conclusions:Relevant departments should strive to establish sharing mechanism, build sharing platforms, refine the sharing access qualification and improve the sharing awareness of medical personnel so as to lay a necessary foundation for further open sharing of big data on digestive diseases.
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Objective:To analyze data safety problem raised from personal medical data sharing and privacy protection, provide suggestions for improving its application and development.Methods:The personal medical data sharing and privacy protection measures were discussed according to the study of related literatures, typical case analysis, analyzing the current situation and its development trend of legislation status of personal medical data sharing and privacy protection.Results:Medical data is one kind of personal data, but more sensitive than other personal data. The country should strengthen relevant legislation, more clearly define relevant concepts, establish the authority and scope of personal medical data processing, improve the effectiveness and operability of laws, maximize the public interest of data, and ensure the balance between the personal data processing and privacy security.Conclusions:The personal medical data sharing and privacy protection is a systematic project. The solution of the personal security risks is also based on a comprehensive safeguard system which including laws, regulations, management and technology.
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With the explosive growth of " City-customized Medical Insurance" products, the voice of commercial health insurance needs medical insurance data support is increasing.The authors took " City-customized Medical Insurance" as the representative of commercial health insurance, analyzed the demands and motivations of stakeholders in medical insurance data sharing through the power-interest matrix model, and summarized the medical insurance data sharing path at the commercial insurance product design end and claim settlement end. It is suggested to strengthen the top-level design, build the implementation path of standardized sharing of medical insurance data and the operation mechanism of hospital data docking, to realize the value increment of all stakeholders.
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Introducción: Compartir datos es una práctica que beneficia y nutre a la ciencia abierta. La reutilización de datos sin procesar puede aportar nuevos resultados de investigación y otorga un segundo uso a los conjuntos de datos creados con otro fin, que además pueden servir como respaldo de los resultados de investigación. Objetivo: Exponer y actualizar los aspectos más importantes relacionados con el uso compartido de datos como parte del proceso de investigación. Material y Métodos: Se realizó un estudio bibliográfico que analiza y compila los principales aspectos que debe conocer un investigador que pretende compartir los datos de resultantes de sus investigaciones. Se empleó el análisis de contenido y el análisis documental clásico para la selección de documentos relevantes al estudio de la temática analizada. Desarrollo: Se establece una guía de repositorios de datos y buscadores de repositorios, donde se explican sus principales características. Se explica la importancia del papel de las revistas en el proceso de compartir datos de investigación y las tendencias internacionales de revistas científicas, así como los niveles de acceso a los set de datos de las investigaciones. Se abordan las ventajas de la aplicación de data sharing y su importancia. Conclusiones: Se ofrecen recomendaciones que se deben considerar para elegir repositorios cuando se pretende alojar datos de investigación(AU)
Introduction: Data sharing is a practice that benefits and nurtures open science movement. The reuse of raw data can provide new research results and give a second use to data sets created for another purpose, which can also serve as a support for research results. Objective: To present and update the most important aspects related to data sharing as part of the research process. Material and Methods: This is a bibliographic study that analyzes and compiles the main aspects that a researcher who intends to share the data resulting from his research should know. Content analysis and classic documentary analysis were used for the selection of documents relevant to the study on the subject analyzed. Development: A guide to data repositories and repository search engines is established, and its main characteristics are explained. The importance of the role of journals in the process of sharing research data, international trends in scientific journals, and the levels of access to research data sets, are explained. The advantages of the application of data sharing and its importance are discussed. Conclusions: Recommendations, which should be considered when choosing repositories to host research data, are offered(AU)
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Humans , World Health Organization , Information Dissemination , Access to Information/ethicsABSTRACT
Based on 18 hospitals including the Chinese People's Liberation Army General Hospital and Peking University People's Hospital, and based on the "Specifications for Perioperative Data", explore the construction and application of perioperative multi-center data centers in the era of medical big data. The use of data ferry technology avoids hidden safety hazards in hospitals, realizes the integration and sharing of perioperative medical data of various medical institutions, and forms a complete data chain combining patient medical data and follow-up data.
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Humans , Hospitals, Military , Military Personnel , United StatesABSTRACT
With the upsurge of medical artificial intelligence,the use of computer vision technology to study medical images,which can effectively help doctors to identify and screen diseases,has become a focus of researchers.This paper summarizes the basic situation,specific information,related research,and data sharing and utilizing ways of foreign breast image datasets.This review provides inspirations for the opening of Chinese medical and health data.
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Artificial Intelligence , Breast/diagnostic imagingABSTRACT
The Human Variome Project (HVP) is an international effort aiming systematically to collect and share information on all human genetic variants. It has been working for years in collaboration with local scientific societies by establishing systems to collect every genetic variant reported in a country and to store these variants within a database repository: LOVD (Argentinian chapter: ar.lovd.org). Formally established in 2017 in the Argentinian Node, up to June 2019 we collected more than 25,000 genetic variants deposited by 17 different laboratories. Nowadays the HVP country nodes represent more than 30 countries. In Latin America there are four country nodes: Argentina, Brazil, Mexico and Venezuela; the first two interacted recently launching the LatinGen database. In the present work we want to share our experience in applying the HVP project focusing on its organization, rules and nomenclature to reach the goal of sharing genetic variants and depositing them in the Leiden Open Variation Database. Contributing laboratories are seeking to share variant data to gain access all over the country. It is one of our goals to stimulate the highest quality by organizing courses, applying current nomenclature rules, sponsoring lectures in national congresses, distributing newsletter to serve the Argentinian genomics community and to stimulate the interaction among Latin America countries.
El Proyecto Varioma Humano (HVP) es un esfuerzo internacional que tiene como objetivo recopilar y compartir sistemáticamente información sobre todas las variantes genéticas humanas. Hemos estado trabajando durante tres años en colaboración con sociedades científicas locales, mediante el establecimiento de sistemas para recolectar todas las variantes genéticas reportadas en el país y almacenarlas dentro de la base de datos LOVD (capítulo argentino: ar.lovd.org). En el año 2017 fue establecido formalmente el Nodo Argentino del HVP, habiéndose recolectado más de 25.000 variantes genéticas depositadas por 17 laboratorios diferentes hasta junio de 2019. Hoy en día existen al menos 30 nodos del HVP, correspondientes a diferentes países. En América Latina hay cuatro nodos: Argentina, Brasil, México y Venezuela; Los dos primeros interactuaron recientemente lanzando la base de datos LatinGen. En el presente trabajo queremos compartir nuestra experiencia en la aplicación del proyecto HVP centrándonos en su organización, reglas y nomenclatura para alcanzar el objetivo de compartir variantes genéticas y depositarlas en la base de datos de variaciones abiertas de Leiden (LOVD). Es uno de nuestros objetivos estimular la más alta calidad mediante la organización de cursos, aplicación de las reglas de nomenclatura actuales, patrocinio de conferencias en congresos nacionales, distribución de boletines informativos para la comunidad de genómica argentina, y estimulación de la interacción entre los países de América Latina.
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In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.
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China , Device Approval , TechnologyABSTRACT
Over the past decade, practice of sharing brain magnetic resonance imaging (MRI) data is increasing given significance of reproducibility and transparency in human neuroscience. Larger multimodal brain MRI databases are needed for more robust research findings considering potential possibilities of large variability in human neuroscience. There are currently more than tens of thousands of shared brain MRI datasets across multiple conditions and hundreds of neuroimaging studies using multimodality through shared brain MRI data repositories. This article critically reviews aims, procedures, and current state of brain MRI data sharing. This review focuses on projects and research findings using structural and functional MRI open databases and is further divided into T1- and diffusion-weighted images for structural MRI as well as resting-state and task-based functional MRI. The challenges and directions are finally discussed. Advances in brain MRI data sharing will lead to more rapid progression in human neuroscience by fostering effective longitudinal, multi-site, multimodal neuroimaging research.
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Humans , Brain , Dataset , Foster Home Care , Information Dissemination , Magnetic Resonance Imaging , Neuroimaging , Neurosciences , Transcutaneous Electric Nerve StimulationABSTRACT
Objective Chronic obstructive pulmonary disease,asthma,interstitial lung disease and pulmonary thromboembolism are the most common and severe respiratory diseases,which seriously jeopardizing the health of the Chinese citizens.Large-scale prospective cohort studies are needed to explore the relationships between potential risk factors and respiratory disease outcomes and to observe disease prognoses through long-term follow-ups.We aimed to develop a common data model (CDM) for cohort studies on respiratory diseases,in order to harmonize and facilitate the exchange,pooling,sharing,and storing of data from multiple sources to serve the purpose of reusing or uniforming those follow-up data appeared in the cohorts.Methods The process of developing this CDM of respiratory diseases would follow the steps as:①Reviewing the international standards,including the Clinical Data Interchange Standards Consortium (CDISC),Clinical Data Acquisition Standards Harmonization (CDASH) and the Observational Medical Outcomes Partnership (OMOP) CDM;②Summarizing four cohort studies of respiratory diseases recruited in this research and assessing the data availability;③Developing a CDM related to respiratory diseases.Results Data on recruited cohorts shared a few similar domains but with various schema.The cohorts also shared homogeneous data collection purposes for future follow-up studies,making the harmonization of current and future data feasible.The derived CDM would include two parts:①thirteen common domains for all the four cohorts and derived variables from disparate questions with a common schema,②additional domains designed upon disease-specific research needs,as well as additional variables that were disease-specific but not initially included in the common domains.Conclusion Data harmonization appeared essential for sharing,comparing and pooled analyses,both retrospectively and prospectively.CDM was needed to convert heterogeneous data from multiple studies into one harmonized dataset.The use of a CDM in multicenter respiratory cohort studies would make the constant collection of uniformed data possible,so to guarantee the data exchange and sharing in the future.
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Hospital information platform had its present situation and problems in integration introduced, and its construction contents and mode were described. The solutions from some famous foreign companies such as Orion and InterSystems were discussed from the aspects of core architecture and technical characteristics.It's pointed out that urgent requirements and the benefit balance between different companies had to be emphasized so as to develop a platform for data sharing and exchange as well as information export.
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Block chain, as a decentralized, trustless database technology program with an intact information trans-parency and a privacy protection function, can be use to construct a highly effective and reliable transmission sys-tem and promote the Internet to become an infrastructure in building the society-trusted network. Block chain is of significant advantages in optimizing the business processes, reducing the operation cost and improving the synergis-tic efficiency in financial industry, and is thus rapidly applied in other industries. The construction of health and medical big data is faced with the challenge of both information security and privacy protection in health field. Block chain is characterized by high fault tolerance, unaltered infrastructure and privacy protection function, and has thus a large room for its application in medical treatment, pharmaceutical industry, medical insurance and ge-nomics.
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The current sharing of medical data and its restrictive factors were surveyed by literature and question-naire investigation and analyzed with statistical analysis tools such as SPSS and Excel, which showed the influence of different restrictive factors on different populations. Certain measures were put forward for speeding up the sha-ring of scientific data, improving the medical treatment and academic level, strengthening the competitive power of hospitals and higher education institutions in Hunan Province.
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Objective Chronic obstructive pulmonary disease,asthma,interstitial lung disease and pulmonary thromboembolism are the most common and severe respiratory diseases,which seriously jeopardizing the health of the Chinese citizens.Large-scale prospective cohort studies are needed to explore the relationships between potential risk factors and respiratory disease outcomes and to observe disease prognoses through long-term follow-ups.We aimed to develop a common data model (CDM) for cohort studies on respiratory diseases,in order to harmonize and facilitate the exchange,pooling,sharing,and storing of data from multiple sources to serve the purpose of reusing or uniforming those follow-up data appeared in the cohorts.Methods The process of developing this CDM of respiratory diseases would follow the steps as:①Reviewing the international standards,including the Clinical Data Interchange Standards Consortium (CDISC),Clinical Data Acquisition Standards Harmonization (CDASH) and the Observational Medical Outcomes Partnership (OMOP) CDM;②Summarizing four cohort studies of respiratory diseases recruited in this research and assessing the data availability;③Developing a CDM related to respiratory diseases.Results Data on recruited cohorts shared a few similar domains but with various schema.The cohorts also shared homogeneous data collection purposes for future follow-up studies,making the harmonization of current and future data feasible.The derived CDM would include two parts:①thirteen common domains for all the four cohorts and derived variables from disparate questions with a common schema,②additional domains designed upon disease-specific research needs,as well as additional variables that were disease-specific but not initially included in the common domains.Conclusion Data harmonization appeared essential for sharing,comparing and pooled analyses,both retrospectively and prospectively.CDM was needed to convert heterogeneous data from multiple studies into one harmonized dataset.The use of a CDM in multicenter respiratory cohort studies would make the constant collection of uniformed data possible,so to guarantee the data exchange and sharing in the future.
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El Comité Internacional de Editores de Revistas Médicas (ICMJE, por su sigla en inglés) elabora recomendaciones para mejorar las normas editoriales y la calidad científica de las revistas biomédicas. Estas recomendaciones van desde uniformizar los requisitos técnicos hasta cuestiones editoriales más complejas e imprecisas, incluyendo aspectos éticos del proceso científico. Recientemente se han propuesto medidas como el registro de ensayos clínicos, la declaración de conflictos de interés y nuevos criterios para la autoría, resaltando la importancia de la responsabilidad y la rendición de cuentas. El año pasado se lanzó una nueva iniciativa editorial para compartir los datos de los ensayos clínicos. La presente revisión analiza esta innovadora iniciativa con el objetivo de sensibilizar a los lectores, investigadores, autores y editores de la Red de Editores de la Sociedad Europea de Cardiología. Data Sharing: a new editorial initiative of the international committee of medical journal editors. Implications for the Editors´ Network
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.
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Humans , Access to Information , Scientific Publication Ethics , Clinical Trials as TopicABSTRACT
Abstract: The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability -, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
Resumen: El Comite internacional de editores de revistas medicas (CIERM) propone recomendaciones para mejorar los standares editoriales y la calidad científica de las revistas biomédicas. Estas recomendaciones abarcan desde requerimeintos ténicos uniformados a temas editoriales mas complejos y evasivos, como los aspectos bioéticos relacionados con el proceso científico. Recientemente se han propuesto algunas iniciativas editoriales, como el registro de los ensayos clinicos, la declaración de los conflictos de interés y los nuevos criterios para autoría (que destacan la responsabilidad de los autores sobre el estudio). El año pasado se presentó una nueva iniciativa editorial para resaltar la importancia de compartir los datos generados en los estudios clinicos. En este artículo se discute esta nueva iniciativa editorial, con la idea de difundir su conocimiento entre los lectores, investigadores, autores y editores de la red de editores de revistas cardiovasculares nacionales de la Sociedad Europea de Cardiología.
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Periodicals as Topic , Publishing , Cardiology , Information Dissemination , Editorial Policies , International CooperationABSTRACT
Abstract The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.
Resumo O Comitê Internacional de Editores de Revistas Médicas (ICMJE) fornece recomendações para aprimorar o padrão editorial e a qualidade científica das revistas biomédicas. Tais recomendações variam desde requisitos técnicos de uniformização até assuntos editoriais mais complexos e elusivos, como os aspectos éticos do processo científico. Recentemente, foram propostos registro de ensaios clínicos, divulgação de conflitos de interesse e novos critérios de autoria, enfatizando a importância da responsabilidade e da responsabilização. No último ano, lançou-se uma nova iniciativa editorial para fomentar o compartilhamento dos dados de ensaios clínicos. Esta revisão discute essa nova iniciativa visando a aumentar a conscientização de leitores, investigadores, autores e editores filiados à Rede de Editores da Sociedade Europeia de Cardiologia.