NFDI4Health Local Data Hubs Implementing a Tailored Metadata Schema for Health Data.

INTRODUCTION: NFDI4Health is a consortium funded by the German Research Foundation to make structured health data findable and accessible internationally according to the FAIR principles. Its goal is bringing data users and Data Holding Organizations (DHOs) together. It mainly considers DHOs conducting epidemiological and public health studies or clinical trials. METHODS: Local data hubs (LDH) are provided for such DHOs to connect decentralized local research data management within their organizations with the option of publishing shareable metadata via centralized NFDI4Health services such as the German central Health Study Hub. The LDH platform is based on FAIRDOM SEEK and provides a complete and flexible, locally controlled data and information management platform for health research data. A tailored NFDI4Health metadata schema for studies and their corresponding resources has been developed which is fully supported by the LDH software, e.g. for metadata transfer to other NFDI4Health services. RESULTS: The SEEK platform has been technically enhanced to support extended metadata structures tailored to the needs of the user communities in addition to the existing metadata structuring of SEEK. CONCLUSION: With the LDH and the MDS, the NFDI4Health provides all DHOs with a standardized and free and open source research data management platform for the FAIR exchange of structured health data.

Use of Creative Frameworks in Health Care to Solve Data and Information Problems: Scoping Review.

BACKGROUND: Digitization is vital for data management, especially in health care. However, problems still hinder health care stakeholders in their daily work while collecting, processing, and providing health data or information. Data are missing, incorrect, cannot be collected, or information is inadequately presented. These problems can be seen as data or information problems. A proven way to elicit requirements for (software) systems is by using creative frameworks (eg, user-centered design, design thinking, lean UX [user experience], or service design) or creative methods (eg, mind mapping, storyboarding, 6 thinking hats, or interaction room). However, to what extent they are used to solve data or information-related problems in health care is unclear. OBJECTIVE: The primary objective of this scoping review is to investigate the use of creative frameworks in addressing data and information problems in health care. METHODS: Following JBI guidelines and the PRISMA-ScR framework, this paper analyzes selected papers, answering whether creative frameworks addressed health care data or information problems. Focusing on data problems (elicitation or collection, processing) and information problems (provision or visualization), the review examined German and English papers published between 2018 and 2022 using keywords related to "data," "design," and "user-centered." The database SCOPUS was used. RESULTS: Of the 898 query results, only 23 papers described a data or information problem and a creative method to solve it. These were included in the follow-up analysis and divided into different problem categories: data collection (n=7), data processing (n=1), information visualization (n=11), and mixed problems meaning data and information problem present (n=4). The analysis showed that most identified problems fall into the information visualization category. This could indicate that creative frameworks are particularly suitable for solving information or visualization problems and less for other, more abstract areas such as data problems. The results also showed that most researchers applied a creative framework after they knew what specific (data or information) problem they had (n=21). Only a minority chose a creative framework to identify a problem and realize it was a data or information problem (n=2). In response to these findings, the paper discusses the need for a new approach that addresses health care data and information challenges by promoting collaboration, iterative feedback, and user-centered development. CONCLUSIONS: Although the potential of creative frameworks is undisputed, applying these in solving data and information problems is a minority. To harness this potential, a suitable method needs to be developed to support health care system stakeholders. This method could be the User-Centered Data Approach.

The DMPTool NIH DMSP Templates Project.

The DMPTool NIH Data Management and Sharing Plan (DMSP) Templates Project was launched in response to the 2023 NIH Data Management and Sharing (DMS) Policy. This new policy introduced a more structured framework for DMS Plans, featuring six key elements, a departure from the 2003 NIH DMS policy. The project aimed to simplify the process for data librarians, research administrators, and researchers by providing a template with curated guidance, eliminating the need to navigate various policies and guidelines. The template breaks out each Plan section and subsection and provides related guidance and examples at the point of need. This effort has resulted in two NIH DMSP Templates. The first is a generic template (NIH-Default) for all ICs, complying with NOT-OD-21-013 and NOT-OD-22-198. More recently, an NIMH-specific template (NIH-NIMH) was added based on NOT-MH-23-100. As of October 2023, over 5,000 DMS Plans have been written using the main NIH-Default template and the NIH-NIMH alternative template.

Generalized overview infographic: a customizable library instructional material on the NIH Data Management and Sharing Policy.

The Generalized Overview of the NIH Data Management and Sharing Policy Effective 2023.01.15 (Generalized Overview) is an instructional material that provides a basic, clear, and linear understanding of the NIH policy and its requirements. While not developing or utilizing new technology, the Generalized Overview is innovative and notable for creatively using a freely available graphic design tool to translate government policy language into an accessible and understandable infographic that can disseminate important information about the NIH DMS Policy needed by researchers and by those who support them. Shared via a Creative Commons license, others may fully adapt the infographic or may simply add their own institutional contact information. The Generalized Overview can be used by any who find themselves responsible for publicizing and/or teaching the NIH Data Management and Sharing Policy at their respective libraries and institutions. It is intended for educational purposes only and should not be used as a substitute for official guidance from the NIH.

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This study presents a multi-center clinical data management platform that facilitates unified and structured management of real-world data and serves as an ideal tool to enhance the quality and progress of clinical research related to severe acute pancreatitis (SAP). The use of the platform enables clinical teams to obtain safe, accurate, structurally unified, traceable, scene-clear, and fully functional real-world medical data in the diagnosis, treatment, and research of acute pancreatitis (AP).

Unlocking the Power of Real-World Data: A Framework for Sustainable Healthcare.

Real-world data (RWD) has the potential to revolutionize healthcare by offering valuable insights into patient outcomes and treatment efficacy. However, leveraging RWD effectively presents challenges, including its inherent limitations, diverse stakeholders, and insufficient data management pipelines. A proposed framework advocates three essential elements: adherence to FAIR principles (Findable, Accessible, Interoperable, and Reusable), stakeholder engagement and education, and highlighting the need for inclusive, pragmatic federated hybrid pipelines. By employing these strategies, healthcare organizations can overcome obstacles to RWD utilization and foster sustainable progress in patient care.

Using Health IT Standards to Facilitate Metadata Exchange Between Research Data Management Systems.

The National Research Data Infrastructure for Personal Health Data (NFDI4Health) uses Local Data Hubs (LDHs) to manage locally research studies, documents and sensitive personal data to support controlled data sharing. While research data management (RDM) systems facilitate the storage and preparation of data and metadata as well as organizational access, they often lack support for interoperability standards of the application domain. To support the exchange with external registries of research studies, we chose 17 attributes to characterize the most relevant aspects of clinical trials (in the following named "metadata profile"). We implemented the metadata profile in the RDM system FAIRDOM SEEK using core attributes and SEEK's extended metadata feature and created a mapping conforming to the Health Level 7 Fast Healthcare Interoperability Resources (FHIR) standard version R4. Finally, we implemented a prototype application interface for exports in FHIR-JSON format. We plan to extend the interface to serve central registries and support specific FHIR Implementation Guides from various use cases.

A Framework to Support the Standardized Management of Real-World Data.

Relying on our experience on the development of data registration and management systems for clinical and biological data coming from patients with hematological malignancies, as well as on the design of strategies for data collection and analysis to support multi-center, clinical association studies, we designed a framework for the standardized collection and transformation of clinically relevant real-world data into evidence, to meet the challenges of gathering biomedical data collected during daily clinical practice in order to promote basic and clinical research.

Public Availability of Data Management and Analysis Scripts of Studies Conducted on Open-Access Intensive Care Databases.

Intensive care units (ICUs) provide care for critical patients at high risk of morbidity and mortality, and require continuous monitoring of clinical, biological and, imaging parameters. Collaborative ventures have enabled the emergence of large open access databases for the secondary use of Electronic Health Records (EHRs). The objective of this work was to evaluate the availability of scripts and datasets in publications based on ICU open-access databases. We included 910 original articles based on four ICU open-access databases (Amsterdam University Medical Centers Database, eICU Collaborative Research Database, High time resolution ICU dataset, and Medical Information Mart for Intensive Care). The majority of the studies did not provide their data management scripts (n=839, 92.9%), neither the analysis script (n=843, 93.4%) in the article. Attempts to contact the 845 corresponding authors in question resulted in 89.11% (n=753) of our e-mail requests going unanswered over a two-month period. We received 51 automated messages (55.43%) indicating that emails have not been delivered, while 6 messages (6.52%) redirected to alternative email addresses. Only 20 corresponding authors (18.18%) answered, finally providing the requested materials. Despite scientific journals recommendations to share materials, our study unveils the absence of crucial components for the replication of studies by other research teams.

Pilot deployment of a cloud-based universal medical image repository in a large public health system: A protocol study.

This paper outlines the protocol for the deployment of a cloud-based universal medical image repository system. The proposal aims not only at the deployment but also at the automatic expansion of the platform, incorporating Artificial Intelligence (AI) for the analysis of medical image examinations. The methodology encompasses efficient data management through a universal database, along with the deployment of various AI models designed to assist in diagnostic decision-making. By presenting this protocol, the goal is to overcome technical challenges and issues that impact all phases of the workflow, from data management to the deployment of AI models in the healthcare sector. These challenges include ethical considerations, compliance with legal regulations, establishing user trust, and ensuring data security. The system has been deployed, with a tested and validated proof of concept, possessing the capability to receive thousands of images daily and to sustain the ongoing deployment of new AI models to expedite the analysis process in medical image exams.

Standardization of an antimicrobial resistance surveillance network through data management.

Introduction: The rapid spread of COVID-19 worldwide within 2 months demonstrated the vulnerability of the world's population to infectious diseases. In 2015, the Global Antimicrobial Resistance and Use Surveillance System (GLASS) was launched to combat antimicrobial resistance (AMR). However, there has been no comprehensive assessment of the decade-long global battle against AMR based on GLASS data. Methods: South Korea established Kor-GLASS (Korean-GLASS) to proactively monitor data quality and enable international collaborations. A unique feature of Kor-GLASS is the quality control center (QCC), which uses network hubs and ensures standardized, high-quality data through interlaboratory proficiency testing (IPT) and external quality assessment (EQA). In addition, the QCC multifaceted endeavors for integrated data quality management. Results: Since 2020, high-quality AMR data have indicated fluctuating antibiotic resistance rates in South Korea. This trend does not align with the decrease in antibiotic usage seen in humans but coincides with non-human antibiotic sales, indicating a need for greater monitoring of non-human antibiotic resistance. Comprehensive and robust management taking account of the intricate interplay among humans, animals, and the environment is essential. Kor-GLASS has been expanded into a "One Health" multiagency collaborative initiative. Discussion: Although a standardized solution is not suitable for all countries, it must align with the local context and international standards. A centralized top-down management structure such as that of the QCC is essential to ensure continuous data quality coordination. Sustained efforts and surveillance systems are crucial for monitoring and managing AMR and safeguarding human health.

What could improve surgical data system at health facilities with high surgical volume in Ethiopia?

BACKGROUND: The effective management of surgical and anesthesia care relies on quality data and its readily availability for both patient-centered decision-making and facility-level improvement efforts. Recognizing this critical need, the Strengthening Systems for Improved Surgical Outcomes (SSISO) project addressed surgical care data management and information use practices across 23 health facilities from October 2019 to September 2022. This study aimed to evaluate the effectiveness of SSISO interventions in enhancing practices related to surgical data capture, reporting, analysis, and visualization. METHODS: This study employed a mixed method, pre- post intervention evaluation design to assess changes in data management and utilization practices at intervention facilities. The intervention packages included capacity building trainings, monthly mentorship visits facilitated by a hub-and-spoke approach, provision of data capture tools, and reinforcement of performance review teams. Data collection occurred at baseline (February - April 2020) and endline (April - June 2022). The evaluation focused on the availability and appropriate use of data capture tools, as well as changes in performance review practices. Appropriate use of registers was defined as filling all the necessary data onto the registers, and this was verified by completeness of selected key data elements in the registers. RESULTS: The proportion of health facilities with Operation Room (OR) scheduling, referral, and surgical site infection registers significantly increased by 34.8%, 56.5% and 87%, respectively, at project endline compared to baseline. Availability of OR and Anesthesia registers remained high throughout the project, at 91.3% and 95.6%, respectively. Furthermore, the appropriate use of these registers improved, with statistically significant increases observed for OR scheduling registers (34.8% increase). Increases were also noted for OR register (9.5% increase) and anesthesia register (4.5% increase), although not statistically significant. Assessing the prior three months reports, the report submissions to the Ministry of Health/Regional Health Bureau (MOH/RHB) rose from 85 to 100%, reflecting complete reporting at endline period. Additionally, the proportion of surgical teams analyzing and displaying data for informed decision-making significantly increased from 30.4% at baseline to 60.8% at endline period. CONCLUSION: The implemented interventions positively impacted surgical data management and utilization practice at intervention facilities. These positive changes were likely attributable to capacity building trainings and regular mentorship visits via hub-and-spoke approach. Hence, we recommend further investigation into the effectiveness of similar intervention packages in improving surgical data management, data analysis and visualization practices in low- and middle-income country settings.

Towards an Interoperability Landscape for a National Research Data Infrastructure for Personal Health Data.

The German initiative "National Research Data Infrastructure for Personal Health Data" (NFDI4Health) focuses on research data management in health research. It aims to foster and develop harmonized informatics standards for public health, epidemiological studies, and clinical trials, facilitating access to relevant data and metadata standards. This publication lists syntactic and semantic data standards of potential use for NFDI4Health and beyond, based on interdisciplinary meetings and workshops, mappings of study questionnaires and the NFDI4Health metadata schema, and literature search. Included are 7 syntactic, 32 semantic and 9 combined syntactic and semantic standards. In addition, 101 ISO Standards from ISO/TC 215 Health Informatics and ISO/TC 276 Biotechnology could be identified as being potentially relevant. The work emphasizes the utilization of standards for epidemiological and health research data ensuring interoperability as well as the compatibility to NFDI4Health, its use cases, and to (inter-)national efforts within these sectors. The goal is to foster collaborative and inter-sectoral work in health research and initiate a debate around the potential of using common standards.

Assessing external exposome by implementing an Environmental Data Management System using Open Data.

Due to the increasing importance of exposome in environmental epidemiology, feasibility and usefulness of an Environmental Data Management System (EDMS) using Open Data was evaluated. The EDMS includes data from 10 European cities (Celje (Slovenia), Lódz (Poland), Manchester (UK), Palermo (Italy), Paris (France), Porto (Portugal), Regensburg (Germany), Reus (Spain), Rijeka (Croatia), Thessaloniki (Greece)) about external non-specific and specific exposome factors at the city or country level (2017-2020). Findings showed that the highest values of life expectancy were in Reus females (86 years) and Palermo males (81 years). UK had the highest obesity rate (28%), Croatia the highest prescribed drug consumption (62%), Greece and Portugal the highest smoking rates (37%, 42%) and daily alcohol consumption (21%), respectively. The most polluted cities were Thessaloniki for PM10 (38 µg/m3), Lódz for PM2.5 (25 µg/m3), Porto for NO2 (62 µg/m3) and Rijeka for O3 (92 µg/m3). Thessaloniki had the highest grey space (98%) and Lódz the highest cumulative amount of pollen (39,041 p/m3). The highest daily noise levels ≥ 55 dB was in Reus (81% to traffic) and Regensburg (21% to railway). In drinking water, arsenic had the highest value in Thessaloniki (6.4 µg/L), boron in Celje (24 mg/L) and lead in Paris (46.7 µg/L). Portugal and Greece showed the highest pesticide residues in food (7%). In conclusion, utilizing open-access databases enables the translation of research findings into actionable strategies for public health interventions.

Desiderata for discoverability and FAIR adoption of health data hubs.

BACKGROUND: The future European Health Research and Innovation Cloud (HRIC), as fundamental part of the European Health Data Space (EHDS), will promote the secondary use of data and the capabilities to push the boundaries of health research within an ethical and legally compliant framework that reinforces the trust of patients and citizens. OBJECTIVE: This study aimed to analyse health data management mechanisms in Europe to determine their alignment with FAIR principles and data discovery generating best. practices for new data hubs joining the HRIC ecosystem. In this line, the compliance of health data hubs with FAIR principles and data discovery were assessed, and a set of best practices for health data hubs was concluded. METHODS: A survey was conducted in January 2022, involving 99 representative health data hubs from multiple countries, and 42 responses were obtained in June 2022. Stratification methods were employed to cover different levels of granularity. The survey data was analysed to assess compliance with FAIR and data discovery principles. The study started with a general analysis of survey responses, followed by the creation of specific profiles based on three categories: organization type, function, and level of data aggregation. RESULTS: The study produced specific best practices for data hubs regarding the adoption of FAIR principles and data discoverability. It also provided an overview of the survey study and specific profiles derived from category analysis, considering different types of data hubs. CONCLUSIONS: The study concluded that a significant number of health data hubs in Europe did not fully comply with FAIR and data discovery principles. However, the study identified specific best practices that can guide new data hubs in adhering to these principles. The study highlighted the importance of aligning health data management mechanisms with FAIR principles to enhance interoperability and reusability in the future HRIC.

Knowledge infrastructure for integrated data management and analysis supporting new approach methods in predictive toxicology and risk assessment.

The EU-ToxRisk project (2016-2021) was a large European project working towards shifting toxicological testing away from animal tests, towards a toxicological assessment based on comprehensive mechanistic understanding of cause-consequence relationships of chemical adverse effects. More than 40 partners from scientific institutions, industry and regulators coordinated their work towards this goal in a six-year long programme. The breadth and variety of data and knowledge generated, presented a challenging data management landscape. Here, we describe our approach to data management as developed under EU-ToxRisk. The main building blocks of the data infrastructure are: 1) An easy-to-use, extensible data and metadata format; 2) A flexible system with protocols for data capture and sharing from the entire consortium; 3) A methods database for describing and reviewing data generation and processing protocols; 4) Data archiving using a sustainable resource; 5) Data transformation from the archive to the system that provides granular access; 6) Application Programming Interface (API) for access to individual data points; 7) Data exploration and analysis modules, based on a «web notebook¼ approach to executable data processing documentation; and 8) Knowledge portal that ties together all of the above and provides a collaboration space for information exchange across the consortium. This knowledge infrastructure is being extended and refined for the support of follow-up projects (RISK-HUNT3R, ASPIS cluster, European Open Science Cloud (2021-2026)).

StatiCAL: an interactive tool for statistical analysis of biomedical data and scientific valorization.

BACKGROUND: In the realm of biomedical research, the growing volume, diversity and quantity of data has escalated the demand for statistical analysis as it is indispensable for synthesizing, interpreting, and publishing data. Hence the need for accessible analysis tools drastically increased. StatiCAL emerges as a user-friendly solution, enabling researchers to conduct basic analyses without necessitating extensive programming expertise. RESULTS: StatiCAL includes divers functionalities: data management, visualization on variables and statistical analysis. Data management functionalities allow the user to freely add or remove variables, to select sub-population and to visualise selected data to better perform the analysis. With this tool, users can freely perform statistical analysis such as descriptive, graphical, univariate, and multivariate analysis. All of this can be performed without the need to learn R coding as the software is a graphical user interface where all the action can be performed by clicking a button. CONCLUSIONS: StatiCAL represents a valuable contribution to the field of biomedical research. By being open-access and by providing an intuitive interface with robust features, StatiCAL allow researchers to gain autonomy in conducting their projects.

Organizing visions for data-centric management: how Norwegian policy documents construe the use of data in health organizations.

PURPOSE: Norway, like other welfare states, seeks to leverage data to transform its pressured public healthcare system. While managers will be central to doing so, we lack knowledge about how specifically they would do so and what constraints and expectations they operate under. Public sources, like the Norwegian policy documents investigated here, provide important backdrops against which such managerial work emerges. This article therefore aims to analyze how key Norwegian policy documents construe data use in health management. DESIGN/METHODOLOGY/APPROACH: We analyzed five notable policy documents using a "practice-oriented" framework, considering these as arenas for "organizing visions" (OVs) about managerial use of data in healthcare organizations. This framework considers documents as not just texts that comment on a topic but as discursive tools that formulate, negotiate and shape issues of national importance, such as expectations about data use in health management. FINDINGS: The OVs we identify anticipate a bold future for health management, where data use is supported through interconnected information systems that provide relevant information on demand. These OVs are similar to discourse on "evidence-based management," but differ in important ways. Managers are consistently framed as key stakeholders that can benefit from using secondary data, but this requires better data integration across the health system. Despite forward-looking OVs, we find considerable ambiguity regarding the practical, social and epistemic dimensions of data use in health management. Our analysis calls for a reframing, by moving away from the hype of "data-driven" health management toward an empirically-oriented, "data-centric" approach that recognizes the situated and relational nature of managerial work on secondary data. ORIGINALITY/VALUE: By exploring OVs in the Norwegian health policy landscape, this study adds to our growing understanding of expectations towards healthcare managers' use of data. Given Norway's highly digitized health system, our analysis has relevance for health services in other countries.

dtool and dserver: A flexible ecosystem for findable data.

Making data FAIR-findable, accessible, interoperable, reproducible-has become the recurring theme behind many research data management efforts. dtool is a lightweight data management tool that packages metadata with immutable data to promote accessibility, interoperability, and reproducibility. Each dataset is self-contained and does not require metadata to be stored in a centralised system. This decentralised approach means that finding datasets can be difficult. dtool's lookup server, short dserver, as defined by a REST API, makes dtool datasets findable, hence rendering the dtool ecosystem fit for a FAIR data management world. Its simplicity, modularity, accessibility and standardisation via API distinguish dtool and dserver from other solutions and enable it to serve as a common denominator for cross-disciplinary research data management. The dtool ecosystem bridges the gap between standardisation-free data management by individuals and FAIR platform solutions with rigid metadata requirements.

Clinical Education Data Management: Current Landscape in Entry-Level Physical Therapist Education.

BACKGROUND: Data management (DM) systems represent an opportunity for innovation in education and data-driven decision-making (DDDM) in allied health education. Understanding clinical education (CE) DM systems in entry-level physical therapy (PT) education programs could provide valuable insight into structure and operation and may represent opportunities to address CE challenges. The purpose of this study is to describe how PT programs are using CE DM systems to inform recommendations for CE DM and support knowledge sharing and DDDM. SUBJECTS: CE faculty and administrators were recruited from entry-level PT education programs to participate in a cross-sectional survey. METHODS: The authors designed a novel survey which included demographics and use of CE DM systems. Descriptive statistics and content analysis of narrative data were used to examine responses. RESULTS: The survey was distributed to 220 academic PT programs in June 2021 with 111 respondents (50% response rate). Respondents use multiple systems to complete CE tasks (e.g., placement process, on-boarding, agreement tracking, as a CE site database). Forty-three percent (n=47) use one system, 76% (n=35) of those use the same Software as a Service vendor. Eighty-six percent (n=96) are satisfied with their current CE DM system. Respondents enter data related to CE site information, CE environment, length of the CE experience, and accreditation-required clinical instructor information. Ninety-four percent (n=93) and 70% (n=70) extract data to make decisions about the placement process and curriculum, respectively. CONCLUSION: While variability across CE DM systems presents a challenge, survey respondents indicated common practices related to functionality, data entry, and extraction. Clinical education DM systems house critical data to address challenges in CE. Strategies to improve accessibility and use of this data to support DDDM should be explored.