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In order to achieve the goals of the Medical Informatics Initiative (MII), staff with skills in the field of medical informatics and data science are required. Each consortium has established training activities. Further, cross-consortium activities have emerged. This article describes the concepts, implemented programs, and experiences in the consortia. Fifty-one new professorships have been established and 10 new study programs have been created: 1 bachelor's degree and 6 consecutive and 3 part-time master's degree programs. Further, learning and training opportunities can be used by all MII partners. Certification and recognition opportunities have been created.The educational offers are aimed at target groups with a background in computer science, medicine, nursing, bioinformatics, biology, natural science, and data science. Additional qualifications for physicians in computer science and computer scientists in medicine seem to be particularly important. They can lead to higher quality in software development and better support for treatment processes by application systems.Digital learning methods were important in all consortia. They offer flexibility for cross-location and interprofessional training. This enables learning at an individual pace and an exchange between professional groups.The success of the MII depends largely on society's acceptance of the multiple use of medical data in both healthcare and research. The information required for this is provided by the MII's public relations work. There is also an enormous need in society for medical and digital literacy.
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Currículo , Informática Médica , Humanos , Segurança Computacional/normas , Registros Eletrônicos de Saúde/normas , Alemanha , Informática Médica/educação , Competência Profissional/normasRESUMO
The vast and heterogeneous data being constantly generated in clinics can provide great wealth for patients and research alike. The quickly evolving field of medical informatics research has contributed numerous concepts, algorithms, and standards to facilitate this development. However, these difficult relationships, complex terminologies, and multiple implementations can present obstacles for people who want to get active in the field. With a particular focus on medical informatics research conducted in Germany, we present in our Viewpoint a set of 10 important topics to improve the overall interdisciplinary communication between different stakeholders (eg, physicians, computational experts, experimentalists, students, patient representatives). This may lower the barriers to entry and offer a starting point for collaborations at different levels. The suggested topics are briefly introduced, then general best practice guidance is given, and further resources for in-depth reading or hands-on tutorials are recommended. In addition, the topics are set to cover current aspects and open research gaps of the medical informatics domain, including data regulations and concepts; data harmonization and processing; and data evaluation, visualization, and dissemination. In addition, we give an example on how these topics can be integrated in a medical informatics curriculum for higher education. By recognizing these topics, readers will be able to (1) set clinical and research data into the context of medical informatics, understanding what is possible to achieve with data or how data should be handled in terms of data privacy and storage; (2) distinguish current interoperability standards and obtain first insights into the processes leading to effective data transfer and analysis; and (3) value the use of newly developed technical approaches to utilize the full potential of clinical data.
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Informática Médica , Humanos , Currículo , Algoritmos , AlemanhaRESUMO
BACKGROUND: The German Biobank Alliance (GBA) aims to establish a cross-site biobank network. For this endeavor, the so-called Sample Locator, a federated search tool for biospecimens and related data, has been developed, forming the heart of its information technology (IT) infrastructure. OBJECTIVE: To ensure the sustainable use of such a tool, we included researchers as participants in an end user-based usability evaluation. METHODS: To develop a prototype ready for evaluation, we needed input from GBA IT experts. Thus, we conducted a 2-day workshop with 8 GBA IT team members. The focus was on the respective steps of a user-centered design process. With the acquired knowledge, the participants designed low-fidelity mock-ups. The main ideas of these mock-ups were discussed, extracted, and summarized into a comprehensive prototype using Microsoft PowerPoint. Furthermore, we created a questionnaire concerning the usability of the prototype, including the System Usability Scale (SUS), questions on negative and positive aspects, and typical tasks to be fulfilled with the tool. Subsequently, the prototype was pretested on the basis of this questionnaire with researchers who have a biobank background. Based on this preliminary work, the usability analysis was ultimately carried out with researchers and the results were evaluated. RESULTS: Altogether, 27 researchers familiar with sample requests evaluated the prototype. The analysis of the feedback certified a good usability, given that the Sample Locator prototype was seen as intuitive and user-friendly by 74% (20/27) of the participants. The total SUS score by the 25 persons that completed the questionnaire was 80.4, indicating good system usability. Still, the evaluation provided useful advice on optimization potential (eg, offering a help function). CONCLUSIONS: The findings of this usability analysis indicate that the considerations regarding a user-friendly application that have been made in the development process so far strongly coincide with the perception of the study participants. Nevertheless, it was important to engage prospective end users to ensure that the previous development is going in the desired direction and that the Sample Locator will be used in the future. The user comments and suggestions for improvement will be considered in upcoming iterations for refinement.
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Bancos de Espécimes Biológicos/normas , Ferramenta de Busca/normas , Adulto , Feminino , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Wearable devices, mobile technologies, and their combination have been accepted into clinical use to better assess the physical fitness and quality of life of patients and as preventive measures. Usability is pivotal for overcoming constraints and gaining users' acceptance of technology such as wearables and their companion mobile health (mHealth) apps. However, owing to limitations in design and evaluation, interactive wearables and mHealth apps have often been restricted from their full potential. OBJECTIVE: This study aims to identify studies that have incorporated wearable devices and determine their frequency of use in conjunction with mHealth apps or their combination. Specifically, this study aims to understand the attributes and evaluation techniques used to evaluate usability in the health care domain for these technologies and their combinations. METHODS: We conducted an extensive search across 4 electronic databases, spanning the last 30 years up to December 2021. Studies including the keywords "wearable devices," "mobile apps," "mHealth apps," "physiological data," "usability," "user experience," and "user evaluation" were considered for inclusion. A team of 5 reviewers screened the collected publications and charted the features based on the research questions. Subsequently, we categorized these characteristics following existing usability and wearable taxonomies. We applied a methodological framework for scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. RESULTS: A total of 382 reports were identified from the search strategy, and 68 articles were included. Most of the studies (57/68, 84%) involved the simultaneous use of wearables and connected mobile apps. Wrist-worn commercial consumer devices such as wristbands were the most prevalent, accounting for 66% (45/68) of the wearables identified in our review. Approximately half of the data from the medical domain (32/68, 47%) focused on studies involving participants with chronic illnesses or disorders. Overall, 29 usability attributes were identified, and 5 attributes were frequently used for evaluation: satisfaction (34/68, 50%), ease of use (27/68, 40%), user experience (16/68, 24%), perceived usefulness (18/68, 26%), and effectiveness (15/68, 22%). Only 10% (7/68) of the studies used a user- or human-centered design paradigm for usability evaluation. CONCLUSIONS: Our scoping review identified the types and categories of wearable devices and mHealth apps, their frequency of use in studies, and their implementation in the medical context. In addition, we examined the usability evaluation of these technologies: methods, attributes, and frameworks. Within the array of available wearables and mHealth apps, health care providers encounter the challenge of selecting devices and companion apps that are effective, user-friendly, and compatible with user interactions. The current gap in usability and user experience in health care research limits our understanding of the strengths and limitations of wearable technologies and their companion apps. Additional research is necessary to overcome these limitations.
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Aplicativos Móveis , Telemedicina , Humanos , Qualidade de Vida , Telemedicina/métodos , Atenção à Saúde , Instalações de SaúdeRESUMO
BACKGROUND: This study outlines the development of a highly interoperable federated IT infrastructure for academic biobanks located at the major university hospital sites across Germany. High-quality biosamples linked to clinical data, stored in biobanks are essential for biomedical research. We aimed to facilitate the findability of these biosamples and their associated data. Networks of biobanks provide access to even larger pools of samples and data even from rare diseases and small disease subgroups. The German Biobank Alliance (GBA) established in 2017 under the umbrella of the German Biobank Node (GBN), has taken on the mission of a federated data discovery service to make biosamples and associated data available to researchers across Germany and Europe. METHODS: In this context, we identified the requirements of researchers seeking human biosamples from biobanks and the needs of biobanks for data sovereignty over their samples and data in conjunction with the sample donor's consent. Based on this, we developed a highly interoperable federated IT infrastructure using standards such as Fast Healthcare Interoperability Resources (HL7 FHIR) and Clinical Quality Language (CQL). RESULTS: The infrastructure comprises two major components enabling federated real-time access to biosample metadata, allowing privacy-compliant queries and subsequent project requests. It has been in use since 2019, connecting 16 German academic biobanks, with additional European biobanks joining. In production since 2019 it has run 4941 queries over the span of one year on more than 900,000 biosamples collected from more than 170,000 donors. CONCLUSION: This infrastructure enhances the visibility and accessibility of biosamples for research, addressing the growing demand for human biosamples and associated data in research. It also underscores the need for improvements in processes beyond IT infrastructure, aiming to advance biomedical research and similar infrastructure development in other fields.
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Bancos de Espécimes Biológicos , Humanos , Europa (Continente) , Alemanha , Pesquisa Biomédica , Bases de Dados FactuaisRESUMO
The German Association for Medical Informatics, Biometry and Epidemiology (GMDS) aims to develop subject-specific methods, which are then to be applied in collaboration with various medical domains. Furthermore, the support of young scientists is an essential field of activity of the GMDS, since the need for junior staff has increased due to the acceleration in medical digitization. A specially established Presidential Commission strives to promote young talents and scientists in the above-mentioned disciplines. For this purpose, various strategies and concepts are elaborated in regular meetings and finally implemented. These include online formats such as a lecture series on research-related topics, as well as events such as summer schools and PhD symposia.
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Informática Médica , Médicos , Humanos , BiometriaRESUMO
BACKGROUND: The Aligning Biobanking and Data Integration Centers Efficiently project aims to harmonize technologies and governance structures of German university hospitals and their biobanks to facilitate searching for patient data and biospecimens. The central element will be a feasibility tool for researchers to query the availability of samples and data to determine the feasibility of their study project. OBJECTIVE: The objectives of the study were as follows: an evaluation of the overall user interface usability of the feasibility tool, the identification of critical usability issues, comprehensibility of the underlying ontology operability, and analysis of user feedback on additional functionalities. From these, recommendations for quality-of-use optimization, focusing on more intuitive usability, were derived. METHODS: To achieve the study goal, an exploratory usability test consisting of 2 main parts was conducted. In the first part, the thinking aloud method (test participants express their thoughts aloud throughout their use of the tool) was complemented by a quantitative questionnaire. In the second part, the interview method was combined with supplementary mock-ups to collect users' opinions on possible additional features. RESULTS: The study cohort rated global usability of the feasibility tool based on the System Usability Scale with a good score of 81.25. The tasks assigned posed certain challenges. No participant was able to solve all tasks correctly. A detailed analysis showed that this was mostly because of minor issues. This impression was confirmed by the recorded statements, which described the tool as intuitive and user friendly. The feedback also provided useful insights regarding which critical usability problems occur and need to be addressed promptly. CONCLUSIONS: The findings indicate that the prototype of the Aligning Biobanking and Data Integration Centers Efficiently feasibility tool is headed in the right direction. Nevertheless, we see potential for optimization primarily in the display of the search functions, the unambiguous distinguishability of criteria, and the visibility of their associated classification system. Overall, it can be stated that the combination of different tools used to evaluate the feasibility tool provided a comprehensive picture of its usability.
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BACKGROUND: Within the German "Network University Medicine," a portal is to be developed to enable researchers to query on novel coronavirus disease 2019 (COVID-19) data from university hospitals for assessing the feasibility of a clinical study. OBJECTIVES: The usability of a prototype for federated feasibility queries was evaluated to identify design strengths and weaknesses and derive improvement recommendations for further development. METHODS: In the course of a remote usability test with the thinking-aloud method and posttask interviews, 15 clinical researchers evaluated the usability of a prototype of the Feasibility Portal. The identified usability problems were rated according to severity, and improvement recommendations were derived. RESULTS: The design of the prototype was rated as simple, intuitive, and as usable with little effort. The usability test reported a total of 26 problems, 8 of these were rated as "critical." Usability problems and revision recommendations focus primarily on improving the visual distinguishability of selected inclusion and exclusion criteria, enabling a flexible approach to criteria linking, and enhancing the free-text search. CONCLUSION: Improvement proposals were developed for these user problems which will guide further development and the adaptation of the portal to user needs. This is an important prerequisite for correct and efficient use in everyday clinical work in the future. Results can provide developers of similar systems with a good starting point for interface conceptualizations. The methodological approach/the developed test guideline can serve as a template for similar evaluations.
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COVID-19 , COVID-19/epidemiologia , Estudos de Viabilidade , Alemanha , Hospitais Universitários , Humanos , Projetos de PesquisaRESUMO
BACKGROUND: Artificial intelligence (AI) in medicine is a very topical issue. As far as the attitudes and perspectives of the different stakeholders in healthcare are concerned, there is still much to be explored. OBJECTIVE: Our aim was to determine attitudes and aspects towards acceptance of AI applications from the perspective of physicians in university hospitals. METHODS: We conducted individual exploratory expert interviews. Low fidelity mockups were used to show interviewees potential application areas of AI in clinical care. RESULTS: In principle, physicians are open to the use of AI in medical care. However, they are critical of some aspects such as data protection or the lack of explainability of the systems. CONCLUSION: Although some trends in attitudes e.g., on the challenges or benefits of using AI became clear, it is necessary to conduct further research as intended by the subsequent PEAK project.
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Inteligência Artificial , Médicos , Atitude , Atenção à Saúde , Humanos , Assistência ao PacienteRESUMO
BACKGROUND: An essential step in any medical research project after identifying the research question is to determine if there are sufficient patients available for a study and where to find them. Pursuing digital feasibility queries on available patient data registries has proven to be an excellent way of reusing existing real-world data sources. To support multicentric research, these feasibility queries should be designed and implemented to run across multiple sites and securely access local data. Working across hospitals usually involves working with different data formats and vocabularies. Recently, the Fast Healthcare Interoperability Resources (FHIR) standard was developed by Health Level Seven to address this concern and describe patient data in a standardized format. The Medical Informatics Initiative in Germany has committed to this standard and created data integration centers, which convert existing data into the FHIR format at each hospital. This partially solves the interoperability problem; however, a distributed feasibility query platform for the FHIR standard is still missing. OBJECTIVE: This study described the design and implementation of the components involved in creating a cross-hospital feasibility query platform for researchers based on FHIR resources. This effort was part of a large COVID-19 data exchange platform and was designed to be scalable for a broad range of patient data. METHODS: We analyzed and designed the abstract components necessary for a distributed feasibility query. This included a user interface for creating the query, backend with an ontology and terminology service, middleware for query distribution, and FHIR feasibility query execution service. RESULTS: We implemented the components described in the Methods section. The resulting solution was distributed to 33 German university hospitals. The functionality of the comprehensive network infrastructure was demonstrated using a test data set based on the German Corona Consensus Data Set. A performance test using specifically created synthetic data revealed the applicability of our solution to data sets containing millions of FHIR resources. The solution can be easily deployed across hospitals and supports feasibility queries, combining multiple inclusion and exclusion criteria using standard Health Level Seven query languages such as Clinical Quality Language and FHIR Search. Developing a platform based on multiple microservices allowed us to create an extendable platform and support multiple Health Level Seven query languages and middleware components to allow integration with future directions of the Medical Informatics Initiative. CONCLUSIONS: We designed and implemented a feasibility platform for distributed feasibility queries, which works directly on FHIR-formatted data and distributed it across 33 university hospitals in Germany. We showed that developing a feasibility platform directly on the FHIR standard is feasible.
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BACKGROUND: To meet the growing importance of real-word data analysis, clinical data and biosamples must be timely made available. Feasibility platforms are often the first contact point for determining the availability of such data for specific research questions. Therefore, a user-friendly interface should be provided to enable access to this information easily. The German Medical Informatics Initiative also aims to establish such a platform for its infrastructure. Although some of these platforms are actively used, their tools still have limitations. Consequently, the Medical Informatics Initiative consortium MIRACUM (Medical Informatics in Research and Care in University Medicine) committed itself to analyzing the pros and cons of existing solutions and to designing an optimized graphical feasibility user interface. OBJECTIVE: The aim of this study is to identify the system that is most user-friendly and thus forms the best basis for developing a harmonized tool. To achieve this goal, we carried out a comparative usability evaluation of existing tools used by researchers acting as end users. METHODS: The evaluation included three preselected search tools and was conducted as a qualitative exploratory study with a randomized design over a period of 6 weeks. The tools in question were the MIRACUM i2b2 (Informatics for Integrating Biology and the Bedside) feasibility platform, OHDSI's (Observational Health Data Sciences and Informatics) ATLAS, and the Sample Locator of the German Biobank Alliance. The evaluation was conducted in the form of a web-based usability test (usability walkthrough combined with a web-based questionnaire) with participants aged between 26 and 63 years who work as medical doctors. RESULTS: In total, 17 study participants evaluated the three tools. The overall evaluation of usability, which was based on the System Usability Scale, showed that the Sample Locator, with a mean System Usability Scale score of 77.03 (SD 20.62), was significantly superior to the other two tools (Wilcoxon test; Sample Locator vs i2b2: P=.047; Sample Locator vs ATLAS: P=.001). i2b2, with a score of 59.83 (SD 25.36), performed significantly better than ATLAS, which had a score of 27.81 (SD 21.79; Wilcoxon test; i2b2 vs ATLAS: P=.005). The analysis of the material generated by the usability walkthrough method confirmed these findings. ATLAS caused the most usability problems (n=66), followed by i2b2 (n=48) and the Sample Locator (n=22). Moreover, the Sample Locator achieved the highest ratings with respect to additional questions regarding satisfaction with the tools. CONCLUSIONS: This study provides data to develop a suitable basis for the selection of a harmonized tool for feasibility studies via concrete evaluation and a comparison of the usability of three different types of query builders. The feedback obtained from the participants during the usability test made it possible to identify user problems and positive design aspects of the individual tools and compare them qualitatively.
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[This corrects the article DOI: 10.2196/25531.].
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BACKGROUND: Experimental data have shown that the developing brain is especially vulnerable to exogenous noxious substances. The potential effects of anesthetic drugs on brain growth and development are a matter of concern. Clinical studies of children who underwent general anesthesia in their earliest years can make a major contribution to our understanding of the effects of anesthetic drugs on infants and toddlers (i.e., children under age 5). METHODS: Children born at term during the years 2007-2011 who were exposed to general anesthesia before their third birthday were included in the study. Data on general anesthesia were retrospectively evaluated, and the overall intelligence quotient (IQ) was determined prospectively as the primary target parameter. Children who had not been exposed to general anesthesia were recruited as a control group. The non-inferiority threshold was set at a difference of 5 IQ points out of a consideration of clinical relevance. RESULTS: 430 complete data sets were available from exposed children and 67 from members of the control group. The exposed group achieved a mean IQ score of 108.2, with a 95% confidence interval of [107; 109.4]; the corresponding values in the control group were 113 [110; 116.1]. Both groups achieved a mean score that was higher than the expected 100 points. After adjustment for age, socioeconomic status, and sex, the difference between the two groups was 2.9 points [0.2; 5.6], indicating a significantly better outcome in the control group than in the exposed group. The non-inferiority threshold of 5 IQ points was within the confidence interval; thus, non-inferiority was not demonstrated. CONCLUSION: The fact that both groups achieved a higher IQ score than the expected 100 points may be attributable, at least in part, to the restriction of the study to children born at term. The results indicate that general anesthesia in early childhood is not associated with markedly reduced intelligence in later years, although noninferiority could not be demonstrated.
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Anestesia Geral , Inteligência , Anestesia Geral/efeitos adversos , Pré-Escolar , Humanos , Lactente , Recém-Nascido , Testes de Inteligência , Estudos Retrospectivos , Classe SocialRESUMO
BACKGROUND: Biobanks ensure the long-term storage and accessibility of biospecimens and corresponding data sets. Thus, they form the foundation for many research projects which may contribute to improving medical care. With the establishment of the German Biobank Node and Alliance, expertise in biobanking is bundled and strengthened. An important component within this research infrastructure is the set-up of an information technology (IT) network for allowing feasibility requests across individual biobanks. OBJECTIVE: We aim to describe relevant aspects that have shaped the journey to interconnect biobanks, to enhance their visibility within the research-community, to harmonize data, and to enable feasibility searches to support access to available data and biosamples. METHODS: To achieve this task, we resorted to a wide variety of methods: we ran a requirement analysis, decided on the mode of operation for the federated team of IT-developers and on the development approach itself, took related national and international initiatives into account, and concluded with evaluations of the developed software artefacts and the operation of the entire chain of applications. RESULTS: We drew an IT framework including all heterogeneous data aspects derived from our requirement analysis and developed a comprehensive IT infrastructure. The successful implementation benefited from a smooth interaction of a federated IT team distributed across all participating sites that was even able to manage a major technology change mid-project. Authentication and project management services from associated partners could be integrated and the graphic user interface for an intuitive search tool for biospecimens was designed iteratively. The developed code is open source to ensure sustainability and the local implementation is concluded and functioning. The evaluation of the components was positive. CONCLUSIONS: The entire project had given ample opportunity for challenges, predictable and unpredictable-from the mode of operation to changing some of the initial ideas. We learned our lessons concerning personnel, budget planning and technical as well as manual monitoring as well as some requirements arising only during the process of the project. Nevertheless, we can here report a success story of a network infrastructure, highly agile and much easier in local installation than initially anticipated.
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Bancos de Espécimes Biológicos/organização & administração , Serviços de Informação , AlemanhaRESUMO
The COVID-19 pandemic has caused strains on health systems worldwide disrupting routine hospital services for all non-COVID patients. Within this retrospective study, we analyzed inpatient hospital admissions across 18 German university hospitals during the 2020 lockdown period compared to 2018. Patients admitted to hospital between January 1 and May 31, 2020 and the corresponding periods in 2018 and 2019 were included in this study. Data derived from electronic health records were collected and analyzed using the data integration center infrastructure implemented in the university hospitals that are part of the four consortia funded by the German Medical Informatics Initiative. Admissions were grouped and counted by ICD 10 chapters and specific reasons for treatment at each site. Pooled aggregated data were centrally analyzed with descriptive statistics to compare absolute and relative differences between time periods of different years. The results illustrate how care process adoptions depended on the COVID-19 epidemiological situation and the criticality of the disease. Overall inpatient hospital admissions decreased by 35% in weeks 1 to 4 and by 30.3% in weeks 5 to 8 after the lockdown announcement compared to 2018. Even hospital admissions for critical care conditions such as malignant cancer treatments were reduced. We also noted a high reduction of emergency admissions such as myocardial infarction (38.7%), whereas the reduction in stroke admissions was smaller (19.6%). In contrast, we observed a considerable reduction in admissions for non-critical clinical situations, such as hysterectomies for benign tumors (78.8%) and hip replacements due to arthrosis (82.4%). In summary, our study shows that the university hospital admission rates in Germany were substantially reduced following the national COVID-19 lockdown. These included critical care or emergency conditions in which deferral is expected to impair clinical outcomes. Future studies are needed to delineate how appropriate medical care of critically ill patients can be maintained during a pandemic.
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COVID-19/epidemiologia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Hospitais Universitários/estatística & dados numéricos , Pandemias/estatística & dados numéricos , Admissão do Paciente/estatística & dados numéricos , Quarentena/estatística & dados numéricos , Serviço Hospitalar de Emergência/tendências , Previsões , Alemanha/epidemiologia , Hospitalização/tendências , Hospitais Universitários/tendências , Humanos , Admissão do Paciente/tendências , Quarentena/tendências , Estudos Retrospectivos , SARS-CoV-2RESUMO
Digitally engaging patients in their care processes was for many years limited to sharing care related documents (e.g. laboratory or radiology findings, discharge letters) with them through personal electronic health records. Newer concepts have led to the establishment of patient portals as patient frontends to a hospitals electronic health record. Rarely however have complete patient pathways with pre-hospitalization, inpatient stay and post-hospitalization been evaluated to identify chains of communication processes involving clinical care scenarios, as well as subsequent home monitoring scenarios. Neither have such approaches been integrated with digital communication processes related to a patients engagement in medical research projects. In order to enhance hospital-patient relationships in a holistic manner, we hypothesize that an integrated environment (e.g. patient portal) supporting shared decision making and communication in a patient´s care situation and in the same time providing communication processes for patient research engagement will optimize the patient-hospital relationship and be supportive in binding a patient to this care providing institution.
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Registros Eletrônicos de Saúde , Relações Hospital-Paciente , Pacientes Internados , Alta do Paciente , Portais do Paciente , Comunicação , HumanosRESUMO
PURPOSE: Text summarization of clinical trial descriptions has the potential to reduce the time required to familiarize oneself with the subject of studies by condensing long-form detailed descriptions to concise, meaning-preserving synopses. This work describes the process and quality of automatically generated summaries of clinical trial descriptions using extractive text summarization methods. METHODS: We generated a novel dataset from the detailed descriptions and brief summaries of trials registered on clinicaltrials.gov. We executed several text summarization algorithms on the detailed descriptions in this corpus and calculated the standard ROUGE metrics using the brief summaries included in the record as a reference. To investigate the correlation of these metrics with human sentiments, four reviewers assessed the content-completeness of the generated summaries and the helpfulness of both the generated and reference summaries via a Likert scale questionnaire. RESULTS: The filtering stages of the dataset generation process reduce the 277,228 trials registered on clinicaltrials.gov to 101,016 records usable for the summarization task. On average, the summaries in this corpus are 25% the length of the detailed descriptions. Of the evaluated text summarization methods, the TextRank algorithm exhibits the overall best performance with a ROUGE-1 F1 score of 0.3531, ROUGE-2 F1 score of 0.1723, and ROUGE-L F1 score of 0.3003. These scores correlate with the assessment of the helpfulness and content similarity by the human reviewers. Inter-rater agreement for the helpfulness and content similarity was slight and fair respectively (Fleiss' kappa of 0.12 and 0.22). CONCLUSIONS: Extractive summarization is a viable tool for generating meaning-preserving synopses of detailed clinical trial descriptions. Further, the human evaluation has shown that the ROUGE-L F1 score is useful for rating the general quality of generated summaries of clinical trial descriptions in an automated way.
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Ensaios Clínicos como Assunto , Algoritmos , Processamento de Linguagem NaturalRESUMO
BACKGROUND: More and more medical data is being stored digitally in routine care. The secondary use of patient data is only possible to a limited extent for data protection reasons. In order to enable a long-term and far-reaching use of secondary data, a possible approach is to obtain "broad consent" from patients, e.g. on research projects whose purpose is still unknown at the time of consent. OBJECTIVE: To develop and evaluate an interactive eConsent prototype that presents the extensive contents of the "broad consent" in multimedia form for the purpose of a successful and resource-efficient information and consent process. METHODS: The eConsent prototype was designed on basis of a literature review and in accordance with the goals of the German medical informatics initiative. User tests and subsequent questionnaire surveys using the System Usability Scale (SUS) were carried out with patients from a university hospital to assess the prototype's usability. The study was conducted in a quasi-experimental, one-group posttest-only design. RESULTS: The created interactive prototype can present the contents acoustically and visually and offers the possibility to retrieve additional information. With a SUS score of 84,1/100 the results indicate a very good usability of the prototype. CONCLUSION: The next steps will include further refinements of the prototype based on the feedback received and a subsequent study with a broader user group aimed at introducing an eConsent tool as part of a patient portal.
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Multimídia , Humanos , Inquéritos e QuestionáriosRESUMO
BACKGROUND: High-quality clinical data and biological specimens are key for medical research and personalized medicine. The Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC) aims to facilitate access to such biological resources. The accompanying ADOPT BBMRI-ERIC project kick-started BBMRI-ERIC by collecting colorectal cancer data from European biobanks. OBJECTIVES: To transform these data into a common representation, a uniform approach for data integration and harmonization had to be developed. This article describes the design and the implementation of a toolset for this task. METHODS: Based on the semantics of a metadata repository, we developed a lexical bag-of-words matcher, capable of semiautomatically mapping local biobank terms to the central ADOPT BBMRI-ERIC terminology. Its algorithm supports fuzzy matching, utilization of synonyms, and sentiment tagging. To process the anonymized instance data based on these mappings, we also developed a data transformation application. RESULTS: The implementation was used to process the data from 10 European biobanks. The lexical matcher automatically and correctly mapped 78.48% of the 1,492 local biobank terms, and human experts were able to complete the remaining mappings. We used the expert-curated mappings to successfully process 147,608 data records from 3,415 patients. CONCLUSION: A generic harmonization approach was created and successfully used for cross-institutional data harmonization across 10 European biobanks. The software tools were made available as open source.