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Clocks & Sleep Aug 2023Standardization plays a crucial role in ensuring the reliability, reproducibility, and interoperability of research data in the biomedical sciences. Metadata standards...
Standardization plays a crucial role in ensuring the reliability, reproducibility, and interoperability of research data in the biomedical sciences. Metadata standards are one foundation for the FAIR (Findable, Accessible, Interoperable, and Reusable) principles of data management. They facilitate data discovery, understanding, and reuse. However, the adoption of metadata standards in biological research lags in practice. Barriers such as complexity, lack of incentives, technical challenges, resource constraints, and resistance to change hinder widespread adoption. In the field of chronobiology, standardization is essential but faces particular challenges due to the longitudinal nature of experimental data, diverse model organisms, and varied measurement techniques. To address these challenges, we propose an approach that emphasizes simplicity and practicality: the development of README templates tailored for particular data types and species. Through this opinion article, our intention is to initiate a dialogue and commence a community-driven standardization process by engaging potential contributors and collaborators.
PubMed: 37754351
DOI: 10.3390/clockssleep5030033 -
Hamostaseologie Nov 2023Inherited platelet disorders (IPDs) represent a heterogeneous group of disorders that include both quantitative (thrombocytopenia or thrombocytosis) and qualitative...
Inherited platelet disorders (IPDs) represent a heterogeneous group of disorders that include both quantitative (thrombocytopenia or thrombocytosis) and qualitative (thrombocytopathy) defects. To gain better knowledge about the prevalence, pathogenesis, and clinical consequences of specific diseases, to improve diagnosis and treatment of patients with IPD, and to support translational research on a genetic, molecular, and physiological basis, the THROMKIDplus study group currently comprising 24 sites in Germany, Austria, and Switzerland decided to establish a patient registry with associated biomaterial banking for children. This registry is designed as a retrospective-prospective, multicenter observational study and supposed to launch in the second half of 2023. Blood smears, plasma, platelet pellets, and DNA of patients will be stored in certified biomaterial banks for future translational research projects. The main inclusion criteria are (1) diagnosis of or highly suspected IPD after assessment of a THROMKIDplus competence center and (2) patients aged 0 to 17 years. Initial and follow-up data on patient history, laboratory parameters, standardized documentation of bleeding tendency, and congenital defects are collected according to good clinical practice and current data protection acts by using the MARVIN platform, a broadly used data management system supported by the German Society for Pediatric Oncology Hematology (GPOH). The THROMKIDplus study group intends to enroll ∼200 patients retrospectively and an annual amount of ∼50 patients prospectively.
PubMed: 37918839
DOI: 10.1055/a-2117-4639 -
Bulletin of the World Health... Jul 2023Direct application of digital health technologies from high-income settings to low- and middle-income countries may be inappropriate due to challenges around data...
PROBLEM
Direct application of digital health technologies from high-income settings to low- and middle-income countries may be inappropriate due to challenges around data availability, implementation and regulation. Hence different approaches are needed.
APPROACH
Within the Viet Nam ICU Translational Applications Laboratory project, since 2018 we have been developing a wearable device for individual patient monitoring and a clinical assessment tool to improve dengue disease management. Working closely with local staff at the Hospital for Tropical Diseases, Ho Chi Minh City, we developed and tested a prototype of the wearable device. We obtained perspectives on design and use of the sensor from patients. To develop the assessment tool, we used existing research data sets, mapped workflows and clinical priorities, interviewed stakeholders and held workshops with hospital staff.
LOCAL SETTING
In Viet Nam, a lower middle-income country, the health-care system is in the nascent stage of implementing digital health technologies.
RELEVANT CHANGES
Based on patient feedback, we are altering the design of the wearable sensor to increase comfort. We built the user interface of the assessment tool based on the core functionalities selected by workshop attendees. The interface was subsequently tested for usability in an iterative manner by the clinical staff members.
LESSONS LEARNT
The development and implementation of digital health technologies need an interoperable and appropriate plan for data management including collection, sharing and integration. Engagements and implementation studies should be conceptualized and conducted alongside the digital health technology development. The priorities of end-users, and understanding context and regulatory landscape are crucial for success.
Topics: Humans; Vietnam; Artificial Intelligence; Risk Factors; Delivery of Health Care
PubMed: 37397176
DOI: 10.2471/BLT.22.289423 -
Cureus Dec 2023Electronic learning (e-learning) has evolved into a popular educational approach since the coronavirus disease 2019 (COVID-19) pandemic. While this represents an...
INTRODUCTION
Electronic learning (e-learning) has evolved into a popular educational approach since the coronavirus disease 2019 (COVID-19) pandemic. While this represents an additional model for teaching, traditional classroom learning fosters the development of interpersonal skills and enables students to share and discuss specific topics. However, existing research on the comparison of both these modes of learning in the field of dental education is inadequate. This study aimed to evaluate the perceptions of dental students towards both electronic and classroom learning.
METHODS
A cross-sectional questionnaire-based survey was conducted between November 2022 and January 2023 among dental students in Saudi Arabia. Students were questioned on their comparative perceptions of e-learning and classroom learning before, during, and after the COVID-19 pandemic. Questionnaire responses, including demographic data, were collected and tabulated, using electronic data management software. The tabulated data were analyzed to provide descriptive statistics and compare electronic and classroom learning with demographic variables and previous experience with e-learning.
RESULTS
Most respondents reported possessing average information technology (IT) skills and prior experience with e-learning. Blackboard Learning Management System (LMS) (Reston, VA: Blackboard Inc.), Zoom (San Jose, CA: Zoom Video Communications Inc.), and Microsoft Teams (Redmond, WA: Microsoft Corporation) were the most commonly used and advantageous e-learning platforms. While the majority of participants found both methods acceptable for problem-based learning sessions and theoretical lectures, they reported e-learning to be less effective than classroom learning for clinical and practical sessions. Regarding e-learning as a preferred method over classroom learning, most responses were "neutral" or "uncertain." Comparing the mean ranks of the ordinal responses for the different teaching methodologies and the nominal responses for e-learning as the preferred method, no statistically significant interactions were observed for demographic characteristics, IT-skill levels, or prior experience with e-learning.
CONCLUSION
Although enhanced performance and learning capacity are enabled through e-learning, the advantages of personal interactions and the feasibility of practical and clinical dental sessions are achieved only through classroom learning.
PubMed: 38274909
DOI: 10.7759/cureus.51129 -
Nursing Open Aug 2023There is a gap in knowledge about how perinatal eHealth programs function to support autonomy for new and expectant parents from pursuing wellness goals. (Review)
Review
BACKGROUND
There is a gap in knowledge about how perinatal eHealth programs function to support autonomy for new and expectant parents from pursuing wellness goals.
OBJECTIVES
To examine patient engagement (access, personalization, commitment and therapeutic alliance) within the practice of perinatal eHealth.
DESIGN
Scoping review.
METHODS
Five databases were searched in January 2020 and updated in April 2022. Reports were vetted by three researchers and included if they documented maternity/neonatal programs and utilized World Health Organization (WHO) person-centred digital health intervention (DHI) categories. Data were charted using a deductive matrix containing WHO DHI categories and patient engagement attributes. A narrative synthesis was conducted utilizing qualitative content analysis. Preferred Reporting Items for Systematic Reviews and Meta-Analyses 'extension for scoping reviews' guidelines were followed for reporting.
RESULTS
Twelve eHealth modalities were found across 80 included articles. The analysis yielded two conceptual insights: (1) The nature of perinatal eHealth programs: (1) emergence of a complex structure of practice and (2) practising patient engagement within perinatal eHealth.
CONCLUSION
Results will be used to operationalize a model of patient engagement within perinatal eHealth.
Topics: Female; Humans; Infant, Newborn; Pregnancy; Data Management; Parents; Patient Participation; Telemedicine; Therapeutic Alliance
PubMed: 37211718
DOI: 10.1002/nop2.1822 -
Medical Law Review Aug 2023Medicine is one of the biggest use cases for emerging information technologies. Data processing brings huge advantages but forces lawmakers and practitioners to balance... (Review)
Review
When is the processing of data from medical implants lawful? The legal grounds for processing health-related personal data from ICT implantable medical devices for treatment purposes under EU data protection law.
Medicine is one of the biggest use cases for emerging information technologies. Data processing brings huge advantages but forces lawmakers and practitioners to balance between privacy, autonomy, accessibility, and functionality. ICT-connected Implantable Medical Devices plant themselves firmly between traditional medical equipment and software that processes health-related personal data, and these implants face many data management challenges. It is essential that healthcare providers and others can identify and understand the legal grounds they rely on to process data. The European Union is currently updating its framework, and the special provisions in the GDPR, the current ePrivacy Directive, and the coming ePrivacy Regulation all provide enhanced thresholds for processing data. This article provides an overview and explanation of the applicability of the rules and the legal grounds for processing data. We find that only a cumulative application of the GDPR and the ePrivacy rules ensure adequate protection of this data and present the legal grounds for processing in these cases. We discuss the challenges in obtaining and maintaining valid consent and necessity as a legal ground for processing and offer use case-specific discussions of the role of consent long-term and the lack of an adequate 'vital interest' exception in the ePrivacy rules.
Topics: Humans; Computer Security; European Union; Privacy; Prostheses and Implants
PubMed: 36282992
DOI: 10.1093/medlaw/fwac038 -
BMJ Health & Care Informatics Feb 2024In this overview, we describe theObservational Medical Outcomes Partnership Common Data Model (OMOP-CDM), the established governance processes employed in EMR data... (Review)
Review
In this overview, we describe theObservational Medical Outcomes Partnership Common Data Model (OMOP-CDM), the established governance processes employed in EMR data repositories, and demonstrate how OMOP transformed data provides a lever for more efficient and secure access to electronic medical record (EMR) data by health service providers and researchers. Through pseudonymisation and common data quality assessments, the OMOP-CDM provides a robust framework for converting complex EMR data into a standardised format. This allows for the creation of shared end-to-end analysis packages without the need for direct data exchange, thereby enhancing data security and privacy. By securely sharing de-identified and aggregated data and conducting analyses across multiple OMOP-converted databases, patient-level data is securely firewalled within its respective local site. By simplifying data management processes and governance, and through the promotion of interoperability, the OMOP-CDM supports a wide range of clinical, epidemiological, and translational research projects, as well as health service operational reporting. Adoption of the OMOP-CDM internationally and locally enables conversion of vast amounts of complex, and heterogeneous EMR data into a standardised structured data model, simplifies governance processes, and facilitates rapid repeatable cross-institution analysis through shared end-to-end analysis packages, without the sharing of data. The adoption of the OMOP-CDM has the potential to transform health data analytics by providing a common platform for analysing EMR data across diverse healthcare settings.
Topics: Humans; Digital Health; Electronic Health Records; Delivery of Health Care; Databases, Factual; Data Management
PubMed: 38387992
DOI: 10.1136/bmjhci-2023-100953 -
Hawai'i Journal of Health & Social... Oct 2023Pacific evidence-based clinical and translational research is greatly needed. However, there are research challenges that stem from the creation, accessibility,...
Pacific evidence-based clinical and translational research is greatly needed. However, there are research challenges that stem from the creation, accessibility, availability, usability, and compliance of data in the Pacific. As a result, there is a growing demand for a complementary approach to the traditional Western research process in clinical and translational research. The data lifecycle is one such approach with a history of use in various other disciplines. It was designed as a data management tool with a set of activities that guide researchers and organizations on the creation, management, usage, and distribution of data. This manuscript describes the data lifecycle and its use by the Biostatistics, Epidemiology, and Research Design core data science team in support of the Center for Pacific Innovations, Knowledge, and Opportunities program.
Topics: Humans; Native Hawaiian or Other Pacific Islander; Biomedical Research; Biostatistics; Translational Research, Biomedical; Data Management
PubMed: 37901670
DOI: No ID Found -
Applied Clinical Informatics Mar 2024Clinical research, particularly in scientific data, grapples with the efficient management of multimodal and longitudinal clinical data. Especially in neuroscience,...
BACKGROUND
Clinical research, particularly in scientific data, grapples with the efficient management of multimodal and longitudinal clinical data. Especially in neuroscience, the volume of heterogeneous longitudinal data challenges researchers. While current research data management systems offer rich functionality, they suffer from architectural complexity that makes them difficult to install and maintain and require extensive user training.
OBJECTIVES
The focus is the development and presentation of a data management approach specifically tailored for clinical researchers involved in active patient care, especially in the neuroscientific environment of German university hospitals. Our design considers the implementation of FAIR (Findable, Accessible, Interoperable, and Reusable) principles and the secure handling of sensitive data in compliance with the General Data Protection Regulation.
METHODS
We introduce a streamlined database concept, featuring an intuitive graphical interface built on Hypertext Markup Language revision 5 (HTML5)/Cascading Style Sheets (CSS) technology. The system can be effortlessly deployed within local networks, that is, in Microsoft Windows 10 environments. Our design incorporates FAIR principles for effective data management. Moreover, we have streamlined data interchange through established standards like HL7 Clinical Document Architecture (CDA). To ensure data integrity, we have integrated real-time validation mechanisms that cover data type, plausibility, and Clinical Quality Language logic during data import and entry.
RESULTS
We have developed and evaluated our concept with clinicians using a sample dataset of subjects who visited our memory clinic over a 3-year period and collected several multimodal clinical parameters. A notable advantage is the unified data matrix, which simplifies data aggregation, anonymization, and export. THIS STREAMLINES DATA EXCHANGE AND ENHANCES DATABASE INTEGRATION WITH PLATFORMS LIKE KONSTANZ INFORMATION MINER (KNIME): .
CONCLUSION
Our approach offers a significant advancement for capturing and managing clinical research data, specifically tailored for small-scale initiatives operating within limited information technology (IT) infrastructures. It is designed for immediate, hassle-free deployment by clinicians and researchers.The database template and precompiled versions of the user interface are available at: https://github.com/stebro01/research_database_sqlite_i2b2.git.
Topics: Humans; Data Management; Programming Languages
PubMed: 38301729
DOI: 10.1055/a-2259-0008 -
PloS One 2023The article describes the results of the online survey on open science (OS) carried out on researchers affiliated with universities and Spanish research centres and...
The article describes the results of the online survey on open science (OS) carried out on researchers affiliated with universities and Spanish research centres and focused on open access to scientific publications, the publication process, the management of research data and the review of open articles. The main objective was to identify the perception and habits of researchers with regard to practices closely linked to open science and the scientific value added is that offers an in-depth picture of researchers as one of the main actors to whom this transformation and implementation of open science will fall. It focuses on the different aspects of OS: open access, open data, publication process and open review in order to identify habits and perceptions. This is to make possible an implementation of the OS movement. The survey was carried out among researchers who had published in the years 2020-2021, according to data obtained from WoS. It was emailed to a total of 8,188 researchers and obtained a total of 666 responses, of which 554 were complete, the rest being forms with some questions unanswered. The main results showed that open access still requires the diffusion of practices and services provided by the institution, as well as training (library or equivalent service) and institutional support from the competent authorities (vice rectors or equivalent) in specific aspects such as data management. In the case of data, around 50% of respondents stated they had stored data in a repository, and of all the options, the most frequently given was that of an institutional repository, followed by a discipline repository. Among the main reasons for doing this, we found transparency, visibility of data and the ability to validate results. For those who stated they had never stored data, the most frequent reasons for not having done so were privacy and confidentiality, the lack of a mandated data policy or a lack of knowledge of how to do it. In terms of open peer review, participants mentioned a certain reticence to the opening of evaluations due to potential conflicts of interest that may arise or because lower-quality content might be accepted in order to avoid conflicts. In addition, the hierarchical structure of senior researcher versus junior researcher might affect reviews. The main conclusions indicate a need for persuasion of OA to take place; APCs are an economic barrier rather than the main criterion for journal selection; OPR practices may seem innovative and emerging; scientific and evaluation policies seem to have a clear effect on the behaviour of researchers; researchers state that they share research data more for reasons of persuasion than out of obligation. Researchers do question the pathways or difficulties that may arise on a day-to-day basis and seem aware that we are undergoing change, where academic evaluation or policies related to open science, its implementation and habits among researchers may change. In this sense, more and better support is needed on the part of institutions and faculty support services.
Topics: Humans; Access to Information; Peer Review; Habits; Privacy
PubMed: 37440550
DOI: 10.1371/journal.pone.0288313