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1.
Front Med (Lausanne) ; 11: 1370916, 2024.
Article in English | MEDLINE | ID: mdl-38966540

ABSTRACT

Introduction: The conect4children (c4c) project aims to facilitate efficient planning and delivery of paediatric clinical trials. One objective of c4c is data standardization and reuse. Interoperability and reusability of paediatric clinical trial data is challenging due to a lack of standardization. The Clinical Data Interchange Standards Consortium (CDISC) standards that are required or recommended for regulatory submissions in several countries lack paediatric specificity with limited awareness within academic institutions. To address this, c4c and CDISC collaborated to develop the Pediatrics User Guide (PUG) consisting of cross-cutting data items that are routinely collected in paediatric clinical trials, factoring in all paediatric age ranges. Methods and Results: The development of the PUG consisted of six stages. During the scoping phase, subtopics (each containing several clinically relevant concepts) were suggested and debated for inclusion in the PUG. Ninety concepts were selected for the modelling phase. Concept maps describing the Research Topic and representation procedure were developed for the 19 concepts that had no (or partial) previous modelling in CDISC. Next, metadata and implementation examples were developed for concepts. This was followed by a CDISC internal review and a public review. For both these review stages, the feedback comments were either implemented or rejected based on budget, timelines, expert review, and scope. The PUG was published on the CDISC website on February 23, 2023. Discussion: The PUG is a first step in bridging the lack of child specific CDISC standards, particularly within academia. Several academic and industrial partners were involved in the development of the PUG, and c4c has undertaken multiple steps to publicize the PUG within its academic partner organizations - in particular, the European Reference Networks (ERNs) that are developing registries and dictionaries in 24 disease areas. In the long term, continued use of the PUG in paediatric clinical trials will enable the pooling of data from multiple trials, which is particularly important for medical domains with small populations.

2.
Int J Qual Stud Health Well-being ; 19(1): 2374733, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38988233

ABSTRACT

PURPOSE: To explore whether and how eHealth solutions support the dignity of healthcare professionals and patients in palliative care contexts. METHOD: This qualitative study used phenomenographic analysis involving four focus group interviews, with healthcare professionals who provide palliative care to older people. RESULTS: Analysis revealed four categories of views on working with eHealth in hierarchical order: Safeguarding the patient by documenting-eHealth is a grain of support, Treated as less worthy by authorities-double standards, Distrust in the eHealth solution-when the "solution" presents a danger; and Patient first-personal contact with patients endows more dignity than eHealth. The ability to have up-to-date patient information was considered crucial when caring for vulnerable, dying patients. eHealth solutions were perceived as essential technological support, but also as unreliable, even dangerous, lacking patient information, with critical information potentially missing or overlooked. This caused distrust in eHealth, introduced unease at work, and challenged healthcare professionals' identities, leading to embodied discomfort and feeling of a lack of dignity. CONCLUSION: The healthcare professionals perceived work with eHealth solutions as challenging their sense of dignity, and therefore affecting their ability to provide dignified care for the patients. However, healthcare professionals managed to provide dignified palliative care by focusing on patient first.


Subject(s)
Attitude of Health Personnel , Focus Groups , Health Personnel , Palliative Care , Personhood , Qualitative Research , Respect , Telemedicine , Humans , Palliative Care/psychology , Female , Male , Aged , Health Personnel/psychology , Middle Aged , Adult , Trust
4.
J Pathol Inform ; 15: 100387, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38984198

ABSTRACT

Over the past decade, artificial intelligence (AI) methods in pathology have advanced substantially. However, integration into routine clinical practice has been slow due to numerous challenges, including technical and regulatory hurdles in translating research results into clinical diagnostic products and the lack of standardized interfaces. The open and vendor-neutral EMPAIA initiative addresses these challenges. Here, we provide an overview of EMPAIA's achievements and lessons learned. EMPAIA integrates various stakeholders of the pathology AI ecosystem, i.e., pathologists, computer scientists, and industry. In close collaboration, we developed technical interoperability standards, recommendations for AI testing and product development, and explainability methods. We implemented the modular and open-source EMPAIA Platform and successfully integrated 14 AI-based image analysis apps from eight different vendors, demonstrating how different apps can use a single standardized interface. We prioritized requirements and evaluated the use of AI in real clinical settings with 14 different pathology laboratories in Europe and Asia. In addition to technical developments, we created a forum for all stakeholders to share information and experiences on digital pathology and AI. Commercial, clinical, and academic stakeholders can now adopt EMPAIA's common open-source interfaces, providing a unique opportunity for large-scale standardization and streamlining of processes. Further efforts are needed to effectively and broadly establish AI assistance in routine laboratory use. To this end, a sustainable infrastructure, the non-profit association EMPAIA International, has been established to continue standardization and support broad implementation and advocacy for an AI-assisted digital pathology future.

5.
Curr Protoc ; 4(7): e1099, 2024 Jul.
Article in English | MEDLINE | ID: mdl-39024028

ABSTRACT

With the ever-expanding toolkit of molecular viewers, the ability to visualize macromolecular structures has never been more accessible. Yet, the idiosyncratic technical intricacies across tools and the integration complexities associated with handling structure annotation data present significant barriers to seamless interoperability and steep learning curves for many users. The necessity for reproducible data visualizations is at the forefront of the current challenges. Recently, we introduced MolViewSpec (homepage: https://molstar.org/mol-view-spec/, GitHub project: https://github.com/molstar/mol-view-spec), a specification approach that defines molecular visualizations, decoupling them from the varying implementation details of different molecular viewers. Through the protocols presented herein, we demonstrate how to use MolViewSpec and its 3D view-building Python library for creating sophisticated, customized 3D views covering all standard molecular visualizations. MolViewSpec supports representations like cartoon and ball-and-stick with coloring, labeling, and applying complex transformations such as superposition to any macromolecular structure file in mmCIF, BinaryCIF, and PDB formats. These examples showcase progress towards reusability and interoperability of molecular 3D visualization in an era when handling molecular structures at scale is a timely and pressing matter in structural bioinformatics as well as research and education across the life sciences. © 2024 The Authors. Current Protocols published by Wiley Periodicals LLC. Basic Protocol 1: Creating a MolViewSpec view using the MolViewSpec Python package Basic Protocol 2: Creating a MolViewSpec view with reference to MolViewSpec annotation files Basic Protocol 3: Creating a MolViewSpec view with labels and other advanced features Support Protocol 1: Computing rotation and translation vectors Support Protocol 2: Creating a MolViewSpec annotation file.


Subject(s)
Software , Imaging, Three-Dimensional , Macromolecular Substances/chemistry , Models, Molecular
6.
Hellenic J Cardiol ; 2024 Jul 16.
Article in English | MEDLINE | ID: mdl-39025234

ABSTRACT

Advances in artificial intelligence (AI) and machine learning systems promise faster, more efficient and more personalized care. While many of these models are built on the premise of improving access to the timely screening, diagnosis, and treatment of cardiovascular disease, their validity and accessibility across diverse and international cohorts remains unknown. In this mini-review article, we summarize key obstacles in the effort to design AI systems that will be scalable, accessible, and accurate across distinct geographical and temporal settings. We discuss representativeness, interoperability, quality assurance and the importance of vendor-agnostic data types that will be immediately available to end-users across the globe. These topics illustrate how the timely integration of these principles into AI development is crucial to maximizing the global benefits of AI in cardiology.

7.
Antimicrob Resist Infect Control ; 13(1): 78, 2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39020438

ABSTRACT

BACKGROUND: Healthcare associated infections (HAI) pose a major threat to healthcare systems resulting in an increased burden of disease. Surveillance plays a key role in rapidly identifying these infections and preventing further transmissions. Alas, in German hospitals, the majority of surveillance efforts have been heavily relying on labour intensive processes like manual chart review. In order to be able to identify further starting points for future digital tools and interventions to aid the surveillance of HAI we aimed to gain an understanding of the current state of digitalisation in the context of the general surveillance organisation in German clinics across all care-levels. The end user perspective of infection prevention and control (IPC) professionals was chosen to identify digital interventions that have the biggest impact on the daily surveillance work routines of IPC professionals. Perceived impediments in the advancement of surveillance digitalisation should be explored. METHODS: Following the development of an interview guideline, eight IPC professionals from seven German hospitals of different care levels were questioned in semi- structured interviews between December 2022 and January 2023. These included questions about general surveillance organisation, access to digital data sources, software to aid the surveillance process as well as current issues in the surveillance process and implementation of software systems. Subsequently, after full transcription, the interview sections were categorized in code categories (first deductive then inductive coding) and analysed qualitatively. RESULTS: Results were characterised by high heterogeneity in terms of general surveillance organisation and access to digital data sources. Software configuration of hospital and laboratory information systems (HIS/LIS) as well as patient data management systems (PDMS) varied not only between hospitals of different care levels but also between hospitals of the same care level. Outside research projects, neither fully automatic software nor solutions utilising artificial intelligence have currently been implemented in clinical routine in any of the hospitals. CONCLUSIONS: Access to digital data sources and software is increasingly available to aid surveillance of HAI. Nevertheless, surveillance processes in hospitals analysed in this study still heavily rely on manual processes. In the analysed hospitals, there is an implementation and funding gap of (semi-) automatic surveillance solutions in clinical practice, especially in healthcare facilities of lower care levels.


Subject(s)
Cross Infection , Hospitals , Infection Control , Humans , Germany/epidemiology , Cross Infection/prevention & control , Infection Control/methods , Automation , Software , Population Surveillance/methods
8.
Sensors (Basel) ; 24(12)2024 Jun 11.
Article in English | MEDLINE | ID: mdl-38931564

ABSTRACT

Healthcare is undergoing a fundamental shift in which digital health tools are becoming ubiquitous, with the promise of improved outcomes, reduced costs, and greater efficiency. Healthcare professionals, patients, and the wider public are faced with a paradox of choice regarding technologies across multiple domains. Research is continuing to look for methods and tools to further revolutionise all aspects of health from prediction, diagnosis, treatment, and monitoring. However, despite its promise, the reality of implementing digital health tools in practice, and the scalability of innovations, remains stunted. Digital health is approaching a crossroads where we need to shift our focus away from simply looking at developing new innovations to seriously considering how we overcome the barriers that currently limit its impact. This paper summarises over 10 years of digital health experiences from a group of researchers with backgrounds in physical therapy-in order to highlight and discuss some of these key lessons-in the areas of validity, patient and public involvement, privacy, reimbursement, and interoperability. Practical learnings from this collective experience across patient cohorts are leveraged to propose a list of recommendations to enable researchers to bridge the gap between the development and implementation of digital health tools.


Subject(s)
Delivery of Health Care , Humans , Biomedical Technology/trends , Biomedical Technology/methods , Delivery of Health Care/trends
9.
BMC Med Inform Decis Mak ; 24(1): 185, 2024 Jun 28.
Article in English | MEDLINE | ID: mdl-38943152

ABSTRACT

INTRODUCTION: This paper outlines the design, implementation, and usability study results of the patient empowerment process for chronic disease management, using Patient Reported Outcome Measurements and Shared Decision-Making Processes. BACKGROUND: The ADLIFE project aims to develop innovative, digital health solutions to support personalized, integrated care for patients with severe long-term conditions such as Chronic Obstructive Pulmonary Disease, and/or Chronic Heart Failure. Successful long-term management of patients with chronic conditions requires active patient self-management and a proactive involvement of patients in their healthcare and treatment. This calls for a patient-provider partnership within an integrated system of collaborative care, supporting self-management, shared-decision making, collection of patient reported outcome measures, education, and follow-up. METHODS: ADLIFE follows an outcome-based and patient-centered approach where PROMs represent an especially valuable tool to evaluate the outcomes of the care delivered. We have selected 11 standardized PROMs for evaluating the most recent patients' clinical context, enabling the decision-making process, and personalized care planning. The ADLIFE project implements the "SHARE approach' for enabling shared decision-making via two digital platforms for healthcare professionals and patients. We have successfully integrated PROMs and shared decision-making processes into our digital toolbox, based on an international interoperability standard, namely HL7 FHIR. A usability study was conducted with 3 clinical sites with 20 users in total to gather feedback and to subsequently prioritize updates to the ADLIFE toolbox. RESULTS: User satisfaction is measured in the QUIS7 questionnaire on a 9-point scale in the following aspects: overall reaction, screen, terminology and tool feedback, learning, multimedia, training material and system capabilities. With all the average scores above 6 in all categories, most respondents have a positive reaction to the ADLIFE PEP platform and find it easy to use. We have identified shortcomings and have prioritized updates to the platform before clinical pilot studies are initiated. CONCLUSIONS: Having finalized design, implementation, and pre-deployment usability studies, and updated the tool based on further feedback, our patient empowerment mechanisms enabled via PROMs and shared decision-making processes are ready to be piloted in clinal settings. Clinical studies will be conducted based at six healthcare settings across Spain, UK, Germany, Denmark, and Israel.


Subject(s)
Decision Making, Shared , Patient Participation , Patient Reported Outcome Measures , Humans , Chronic Disease/therapy , Empowerment
10.
BMC Med Inform Decis Mak ; 24(1): 184, 2024 Jun 27.
Article in English | MEDLINE | ID: mdl-38937817

ABSTRACT

An ever-increasing amount of data on a person's daily functioning is being collected, which holds information to revolutionize person-centered healthcare. However, the full potential of data on daily functioning cannot yet be exploited as it is mostly stored in an unstructured and inaccessible manner. The integration of these data, and thereby expedited knowledge discovery, is possible by the introduction of functionomics as a complementary 'omics' initiative, embracing the advances in data science. Functionomics is the study of high-throughput data on a person's daily functioning, that can be operationalized with the International Classification of Functioning, Disability and Health (ICF).A prerequisite for making functionomics operational are the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This paper illustrates a step by step application of the FAIR principles for making functionomics data machine readable and accessible, under strictly certified conditions, in a practical example. Establishing more FAIR functionomics data repositories, analyzed using a federated data infrastructure, enables new knowledge generation to improve health and person-centered healthcare. Together, as one allied health and healthcare research community, we need to consider to take up the here proposed methods.


Subject(s)
Activities of Daily Living , Humans , Patient-Centered Care , International Classification of Functioning, Disability and Health
11.
J Med Internet Res ; 26: e54265, 2024 Jun 25.
Article in English | MEDLINE | ID: mdl-38916936

ABSTRACT

BACKGROUND: Evidence-based medicine (EBM) has the potential to improve health outcomes, but EBM has not been widely integrated into the systems used for research or clinical decision-making. There has not been a scalable and reusable computer-readable standard for distributing research results and synthesized evidence among creators, implementers, and the ultimate users of that evidence. Evidence that is more rapidly updated, synthesized, disseminated, and implemented would improve both the delivery of EBM and evidence-based health care policy. OBJECTIVE: This study aimed to introduce the EBM on Fast Healthcare Interoperability Resources (FHIR) project (EBMonFHIR), which is extending the methods and infrastructure of Health Level Seven (HL7) FHIR to provide an interoperability standard for the electronic exchange of health-related scientific knowledge. METHODS: As an ongoing process, the project creates and refines FHIR resources to represent evidence from clinical studies and syntheses of those studies and develops tools to assist with the creation and visualization of FHIR resources. RESULTS: The EBMonFHIR project created FHIR resources (ie, ArtifactAssessment, Citation, Evidence, EvidenceReport, and EvidenceVariable) for representing evidence. The COVID-19 Knowledge Accelerator (COKA) project, now Health Evidence Knowledge Accelerator (HEvKA), took this work further and created FHIR resources that express EvidenceReport, Citation, and ArtifactAssessment concepts. The group is (1) continually refining FHIR resources to support the representation of EBM; (2) developing controlled terminology related to EBM (ie, study design, statistic type, statistical model, and risk of bias); and (3) developing tools to facilitate the visualization and data entry of EBM information into FHIR resources, including human-readable interfaces and JSON viewers. CONCLUSIONS: EBMonFHIR resources in conjunction with other FHIR resources can support relaying EBM components in a manner that is interoperable and consumable by downstream tools and health information technology systems to support the users of evidence.


Subject(s)
Evidence-Based Medicine , Health Information Interoperability , Evidence-Based Medicine/standards , Humans , Health Information Interoperability/standards , COVID-19 , Health Level Seven
12.
J Pediatr Pharmacol Ther ; 29(3): 323-330, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38863851

ABSTRACT

OBJECTIVES: Smart pump interoperability is a newer technology integrating intravenous medication -infusion instructions from the electronic medical record into a smart pump. This technology has demonstrated significantly decreased medication errors in the adult population; however, this has not been reported in pediatrics. The purpose of this study was to compare the frequency and severity of infusion related errors before and after the implementation of smart pump interoperability at a pediatric institution. METHODS: This was a retrospective study conducted at multiple institutions within the same health care system to assess the effect of smart pump interoperability on infusion errors. Data were retrospectively analyzed for a 6-month period prior to (January-June 2020) and after (January-June 2022) smart pump interoperability implementation. All who received medications via a smart pump were included in the analysis. Infusions were excluded if administered via a patient-controlled analgesia pump, epidural pump, or intravenously pushed without using a smart pump. RESULTS: A total of 143,997 versus 165,343 infusions were administered in the before versus after interoperability group. There were significant decreases in mild, moderate, and severe harm averted events once interoperability was implemented (p < 0.001). Errors caught before administration decreased after interoperability implementation from 197 events to 20 events because of fewer overall errors (p < 0.001). The number of guardrail alert overrides was significantly reduced, from 23,751 to 5885 (p < 0.001), as was the number of high-risk overrides, from 5851 to 207 (p < 0.001). CONCLUSION: Implementing smart pump interoperability significantly reduced the frequency and severity of infusion errors and high-risk overrides at a pediatric institution.

13.
Int J Med Inform ; 189: 105507, 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38870885

ABSTRACT

BACKGROUND: The prevalence of chronic diseases has shifted the burden of disease from incidental acute inpatient admissions to long-term coordinated care across healthcare institutions and the patient's home. Digital healthcare ecosystems emerge to target increasing healthcare costs and invest in standard Application Programming Interfaces (API), such as HL7 Fast Healthcare Interoperability Resources (HL7 FHIR) for trusted data flows. OBJECTIVES: This scoping review assessed the role and impact of HL7 FHIR and associated Implementation Guides (IGs) in digital healthcare ecosystems focusing on chronic disease management. METHODS: To study trends and developments relevant to HL7 FHIR, a scoping review of the scientific and gray English literature from 2017 to 2023 was used. RESULTS: The selection of 93 of 524 scientific papers reviewed in English indicates that the popularity of HL7 FHIR as a robust technical interface standard for the health sector has been steadily rising since its inception in 2010, reaching a peak in 2021. Digital Health applications use HL7 FHIR in cancer (45 %), cardiovascular disease (CVD) (more than 15 %), and diabetes (almost 15 %). The scoping review revealed that references to HL7 FHIR IGs are limited to âˆ¼ 20 % of articles reviewed. HL7 FHIR R4 was most frequently referenced when the HL7 FHIR version was mentioned. In HL7 FHIR IGs registries and the internet, we found 35 HL7 FHIR IGs addressing chronic disease management, i.e., cancer (40 %), chronic disease management (25 %), and diabetes (20 %). HL7 FHIR IGs frequently complement the information in the article. CONCLUSIONS: HL7 FHIR matures with each revision of the standard as HL7 FHIR IGs are developed with validated data sets, common shared HL7 FHIR resources, and supporting tools. Referencing HL7 FHIR IGs cataloged in official registries and in scientific publications is recommended to advance data quality and facilitate mutual learning in growing digital healthcare ecosystems that nurture interoperability in digital health innovation.

15.
PeerJ Comput Sci ; 10: e1781, 2024.
Article in English | MEDLINE | ID: mdl-38855229

ABSTRACT

FAIR Digital Object (FDO) is an emerging concept that is highlighted by European Open Science Cloud (EOSC) as a potential candidate for building an ecosystem of machine-actionable research outputs. In this work we systematically evaluate FDO and its implementations as a global distributed object system, by using five different conceptual frameworks that cover interoperability, middleware, FAIR principles, EOSC requirements and FDO guidelines themself. We compare the FDO approach with established Linked Data practices and the existing Web architecture, and provide a brief history of the Semantic Web while discussing why these technologies may have been difficult to adopt for FDO purposes. We conclude with recommendations for both Linked Data and FDO communities to further their adaptation and alignment.

16.
Gait Posture ; 113: 191-203, 2024 Jun 13.
Article in English | MEDLINE | ID: mdl-38917666

ABSTRACT

BACKGROUND: Over the past decades, tremendous technological advances have emerged in human motion analysis (HMA). RESEARCH QUESTION: How has technology for analysing human motion evolved over the past decades, and what clinical applications has it enabled? METHODS: The literature on HMA has been extensively reviewed, focusing on three main approaches: Fully-Instrumented Gait Analysis (FGA), Wearable Sensor Analysis (WSA), and Deep-Learning Video Analysis (DVA), considering both technical and clinical aspects. RESULTS: FGA techniques relying on data collected using stereophotogrammetric systems, force plates, and electromyographic sensors have been dramatically improved providing highly accurate estimates of the biomechanics of motion. WSA techniques have been developed with the advances in data collection at home and in community settings. DVA techniques have emerged through artificial intelligence, which has marked the last decade. Some authors have considered WSA and DVA techniques as alternatives to "traditional" HMA techniques. They have suggested that WSA and DVA techniques are destined to replace FGA. SIGNIFICANCE: We argue that FGA, WSA, and DVA complement each other and hence should be accounted as "synergistic" in the context of modern HMA and its clinical applications. We point out that DVA techniques are especially attractive as screening techniques, WSA methods enable data collection in the home and community for extensive periods of time, and FGA does maintain superior accuracy and should be the preferred technique when a complete and highly accurate biomechanical data is required. Accordingly, we envision that future clinical applications of HMA would favour screening patients using DVA in the outpatient setting. If deemed clinically appropriate, then WSA would be used to collect data in the home and community to derive relevant information. If accurate kinetic data is needed, then patients should be referred to specialized centres where an FGA system is available, together with medical imaging and thorough clinical assessments.

17.
J Med Internet Res ; 26: e50049, 2024 06 10.
Article in English | MEDLINE | ID: mdl-38857066

ABSTRACT

BACKGROUND: It is necessary to harmonize and standardize data variables used in case report forms (CRFs) of clinical studies to facilitate the merging and sharing of the collected patient data across several clinical studies. This is particularly true for clinical studies that focus on infectious diseases. Public health may be highly dependent on the findings of such studies. Hence, there is an elevated urgency to generate meaningful, reliable insights, ideally based on a high sample number and quality data. The implementation of core data elements and the incorporation of interoperability standards can facilitate the creation of harmonized clinical data sets. OBJECTIVE: This study's objective was to compare, harmonize, and standardize variables focused on diagnostic tests used as part of CRFs in 6 international clinical studies of infectious diseases in order to, ultimately, then make available the panstudy common data elements (CDEs) for ongoing and future studies to foster interoperability and comparability of collected data across trials. METHODS: We reviewed and compared the metadata that comprised the CRFs used for data collection in and across all 6 infectious disease studies under consideration in order to identify CDEs. We examined the availability of international semantic standard codes within the Systemized Nomenclature of Medicine - Clinical Terms, the National Cancer Institute Thesaurus, and the Logical Observation Identifiers Names and Codes system for the unambiguous representation of diagnostic testing information that makes up the CDEs. We then proposed 2 data models that incorporate semantic and syntactic standards for the identified CDEs. RESULTS: Of 216 variables that were considered in the scope of the analysis, we identified 11 CDEs to describe diagnostic tests (in particular, serology and sequencing) for infectious diseases: viral lineage/clade; test date, type, performer, and manufacturer; target gene; quantitative and qualitative results; and specimen identifier, type, and collection date. CONCLUSIONS: The identification of CDEs for infectious diseases is the first step in facilitating the exchange and possible merging of a subset of data across clinical studies (and with that, large research projects) for possible shared analysis to increase the power of findings. The path to harmonization and standardization of clinical study data in the interest of interoperability can be paved in 2 ways. First, a map to standard terminologies ensures that each data element's (variable's) definition is unambiguous and that it has a single, unique interpretation across studies. Second, the exchange of these data is assisted by "wrapping" them in a standard exchange format, such as Fast Health care Interoperability Resources or the Clinical Data Interchange Standards Consortium's Clinical Data Acquisition Standards Harmonization Model.


Subject(s)
Communicable Diseases , Semantics , Humans , Communicable Diseases/diagnosis , Common Data Elements
18.
Front Med (Lausanne) ; 11: 1377209, 2024.
Article in English | MEDLINE | ID: mdl-38903818

ABSTRACT

Introduction: Obtaining real-world data from routine clinical care is of growing interest for scientific research and personalized medicine. Despite the abundance of medical data across various facilities - including hospitals, outpatient clinics, and physician practices - the intersectoral exchange of information remains largely hindered due to differences in data structure, content, and adherence to data protection regulations. In response to this challenge, the Medical Informatics Initiative (MII) was launched in Germany, focusing initially on university hospitals to foster the exchange and utilization of real-world data through the development of standardized methods and tools, including the creation of a common core dataset. Our aim, as part of the Medical Informatics Research Hub in Saxony (MiHUBx), is to extend the MII concepts to non-university healthcare providers in a more seamless manner to enable the exchange of real-world data among intersectoral medical sites. Methods: We investigated what services are needed to facilitate the provision of harmonized real-world data for cross-site research. On this basis, we designed a Service Platform Prototype that hosts services for data harmonization, adhering to the globally recognized Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) international standard communication format and the Observational Medical Outcomes Partnership (OMOP) common data model (CDM). Leveraging these standards, we implemented additional services facilitating data utilization, exchange and analysis. Throughout the development phase, we collaborated with an interdisciplinary team of experts from the fields of system administration, software engineering and technology acceptance to ensure that the solution is sustainable and reusable in the long term. Results: We have developed the pre-built packages "ResearchData-to-FHIR," "FHIR-to-OMOP," and "Addons," which provide the services for data harmonization and provision of project-related real-world data in both the FHIR MII Core dataset format (CDS) and the OMOP CDM format as well as utilization and a Service Platform Prototype to streamline data management and use. Conclusion: Our development shows a possible approach to extend the MII concepts to non-university healthcare providers to enable cross-site research on real-world data. Our Service Platform Prototype can thus pave the way for intersectoral data sharing, federated analysis, and provision of SMART-on-FHIR applications to support clinical decision making.

19.
Heliyon ; 10(10): e31413, 2024 May 30.
Article in English | MEDLINE | ID: mdl-38826724

ABSTRACT

This review explores the Metaverse, focusing on user perceptions and emphasizing the critical aspects of usability, social influence, and interoperability within this emerging digital ecosystem. By integrating various academic perspectives, this analysis highlights the Metaverse's significant impact across various sectors, emphasizing its potential to reshape digital interaction paradigms. The investigation reveals usability as a cornerstone for user engagement, demonstrating how social dynamics profoundly influence user behaviors and choices within virtual environments. Furthermore, the study outlines interoperability as a paramount challenge, advocating for establishing unified protocols and technologies to facilitate seamless experiences across disparate Metaverse platforms. It advocates for the adoption of inclusive, ergonomically oriented designs aimed at enhancing user participation. It addresses the ethical and societal challenges posed by the Metaverse, including concerns related to digital harassment, invasive marketing practices, and breaches of privacy. Additionally, the review identifies existing gaps in the literature, particularly regarding the Metaverse's implications for healthcare, its impact on educational outcomes, and the urgent need for empirical data concerning its long-term effects on user psychology and behavior. By providing a comprehensive synthesis of the current understanding of user experiences and challenges within the Metaverse, this paper contributes to the academic dialogue, laying the groundwork for future research initiatives. It aims to steer the development of the Metaverse towards a trajectory that is ethically sound, socially responsible, inclusive, and aligned with societal expectations, thereby fostering a digital realm that upholds the highest standards of integrity and inclusivity.

20.
Health Informatics J ; 30(2): 14604582241259336, 2024.
Article in English | MEDLINE | ID: mdl-38848696

ABSTRACT

Keeping track of data semantics and data changes in the databases is essential to support retrospective studies and the reproducibility of longitudinal clinical analysis by preventing false conclusions from being drawn from outdated data. A knowledge model combined with a temporal model plays an essential role in organizing the data and improving query expressiveness across time and multiple institutions. This paper presents a modelling framework for temporal relational databases using an ontology to derive a shareable and interoperable data model. The framework is based on: OntoRela an ontology-driven database modelling approach and Unified Historicization Framework a temporal database modelling approach. The method was applied to hospital organizational structures to show the impact of tracking organizational changes on data quality assessment, healthcare activities and data access rights. The paper demonstrated the usefulness of an ontology to provide a formal, interoperable, and reusable definition of entities and their relationships, as well as the adequacy of the temporal database to store, trace, and query data over time.


Subject(s)
Databases, Factual , Humans , Hospital Administration/methods , Data Management/methods
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