Evaluating the Coverage of the HL7 ® FHIR ® Standard to Support eSource Data Exchange Implementations for use in Multi-Site Clinical Research Studies.
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ABSTRACT:
SUBMITTER: Garza MY
PROVIDER: S-EPMC8075534 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:UNLABELLED:To support clinical decision-making, computerized information retrieval tools known as "infobuttons" deliver contextually-relevant knowledge resources into clinical information systems. The Health Level Seven International (HL7) Context-Aware Knowledge Retrieval (Infobutton) Standard specifies a standard mechanism to enable infobuttons on a large scale. OBJECTIVE:To examine the experience of organizations in the course of implementing the HL7 Infobutton Standard. METHOD:Cross-sectional online survey and in-depth phone interviews. RESULTS:A total of 17 organizations participated in the study. Analysis of the in-depth interviews revealed 20 recurrent themes. Implementers underscored the benefits, simplicity, and flexibility of the HL7 Infobutton Standard. Yet, participants voiced the need for easier access to standard specifications and improved guidance to beginners. Implementers predicted that the Infobutton Standard will be widely or at least fairly well adopted in the next 5 years, but uptake will depend largely on adoption among electronic health record (EHR) vendors. To accelerate EHR adoption of the Infobutton Standard, implementers recommended HL7-compliant infobutton capabilities to be included in the United States Meaningful Use Certification Criteria for EHR systems. LIMITATIONS:Opinions and predictions should be interpreted with caution, since all the participant organizations have successfully implemented the standard and over half of the organizations were actively engaged in the development of the standard. CONCLUSION:Overall, implementers reported a very positive experience with the HL7 Infobutton Standard. Despite indications of increasing uptake, measures should be taken to stimulate adoption of the Infobutton Standard among EHR vendors. Widespread adoption of the Infobutton Standard has the potential to bring contextually relevant clinical decision support content into the healthcare provider workflow.
| S-EPMC3334468 | biostudies-literature
Project description:BackgroundMobile health (MH) technologies including clinical decision support systems (CDSS) provide an efficient method for patient monitoring and treatment. A mobile CDSS is based on real-time sensor data and historical electronic health record (EHR) data. Raw sensor data have no semantics of their own; therefore, a computer system cannot interpret these data automatically. In addition, the interoperability of sensor data and EHR medical data is a challenge. EHR data collected from distributed systems have different structures, semantics, and coding mechanisms. As a result, building a transparent CDSS that can work as a portable plug-and-play component in any existing EHR ecosystem requires a careful design process. Ontology and medical standards support the construction of semantically intelligent CDSSs.MethodsThis paper proposes a comprehensive MH framework with an integrated CDSS capability. This cloud-based system monitors and manages type 1 diabetes mellitus. The efficiency of any CDSS depends mainly on the quality of its knowledge and its semantic interoperability with different data sources. To this end, this paper concentrates on constructing a semantic CDSS based on proposed FASTO ontology.ResultsThis realistic ontology is able to collect, formalize, integrate, analyze, and manipulate all types of patient data. It provides patients with complete, personalized, and medically intuitive care plans, including insulin regimens, diets, exercises, and education sub-plans. These plans are based on the complete patient profile. In addition, the proposed CDSS provides real-time patient monitoring based on vital signs collected from patients' wireless body area networks. These monitoring include real-time insulin adjustments, mealtime carbohydrate calculations, and exercise recommendations. FASTO integrates the well-known standards of HL7 fast healthcare interoperability resources (FHIR), semantic sensor network (SSN) ontology, basic formal ontology (BFO) 2.0, and clinical practice guidelines. The current version of FASTO includes 9577 classes, 658 object properties, 164 data properties, 460 individuals, and 140 SWRL rules. FASTO is publicly available through the National Center for Biomedical Ontology BioPortal at https://bioportal.bioontology.org/ontologies/FASTO .ConclusionsThe resulting CDSS system can help physicians to monitor more patients efficiently and accurately. In addition, patients in rural areas can depend on the system to manage their diabetes and emergencies.
| S-EPMC6511155 | biostudies-literature
Project description:HL7 Fast Healthcare Interoperability Resources (FHIR) is an emerging open standard for the exchange of electronic healthcare information. FHIR resources are defined in a specialized modeling language. FHIR instances can currently be represented in either XML or JSON. The FHIR and Semantic Web communities are developing a third FHIR instance representation format in Resource Description Framework (RDF). Shape Expressions (ShEx), a formal RDF data constraint language, is a candidate for describing and validating the FHIR RDF representation.Create a FHIR to ShEx model transformation and assess its ability to describe and validate FHIR RDF data.We created the methods and tools that generate the ShEx schemas modeling the FHIR to RDF specification being developed by HL7 ITS/W3C RDF Task Force, and evaluated the applicability of ShEx in the description and validation of FHIR to RDF transformations.The ShEx models contributed significantly to workgroup consensus. Algorithmic transformations from the FHIR model to ShEx schemas and FHIR example data to RDF transformations were incorporated into the FHIR build process. ShEx schemas representing 109 FHIR resources were used to validate 511 FHIR RDF data examples from the Standards for Trial Use (STU 3) Ballot version. We were able to uncover unresolved issues in the FHIR to RDF specification and detect 10 types of errors and root causes in the actual implementation. The FHIR ShEx representations have been included in the official FHIR web pages for the STU 3 Ballot version since September 2016.ShEx can be used to define and validate the syntax of a FHIR resource, which is complementary to the use of RDF Schema (RDFS) and Web Ontology Language (OWL) for semantic validation.ShEx proved useful for describing a standard model of FHIR RDF data. The combination of a formal model and a succinct format enabled comprehensive review and automated validation.
| S-EPMC5502481 | biostudies-literature
Project description:The 21st Century Cures Act requires that certified health information technology have an application programming interface (API) giving access to all data elements of a patient's electronic health record, "without special effort". In the spring of 2020, the Office of the National Coordinator of Health Information Technology (ONC) published a rule-21st Century Cures Act Interoperability, Information Blocking, and the ONC Health IT Certification Program-regulating the API requirement along with protections against information blocking. The rule specifies the SMART/HL7 FHIR Bulk Data Access API, which enables access to patient-level data across a patient population, supporting myriad use cases across healthcare, research, and public health ecosystems. The API enables "push button population health" in that core data elements can readily and standardly be extracted from electronic health records, enabling local, regional, and national-scale data-driven innovation.
| S-EPMC7678833 | biostudies-literature
Project description:Structured representation of clinical genetic results is necessary for advancing precision medicine. The Electronic Medical Records and Genomics (eMERGE) Network's Phase III program initially used a commercially developed XML message format for standardized and structured representation of genetic results for electronic health record (EHR) integration. In a desire to move towards a standard representation, the network created a new standardized format based upon Health Level Seven Fast Healthcare Interoperability Resources (HL7® FHIR®), to represent clinical genomics results. These new standards improve the utility of HL7® FHIR® as an international healthcare interoperability standard for management of genetic data from patients. This work advances the establishment of standards that are being designed for broad adoption in the current health information technology landscape.
| S-EPMC8583906 | biostudies-literature
Project description:Transport layer security (TLS) protocol is the most widely used security protocol in modern network communications. However, protocol vulnerabilities caused by the design of the network protocol or its implementation by programmers emerge one after another. Meanwhile, various versions of TLS protocol implementations exhibit different behavioral characteristics. Researchers are attempting to find the differences in protocol implementations based on differential testing, which is conducive to discovering the vulnerabilities. This paper provides a solution to find the differences more efficiently by targeting the TLS protocol handshake process. The differences of different implementations during the fuzzing process, such as code coverage and response data, are taken to guide the mutation of test cases, and the seeds are mutated based on the TLS protocol syntax. In addition, the definition of duplicate discrepancies is theoretically explored to investigate the root cause of the discrepancies and to reduce the number of duplicate cases that are caused by the same reason. Besides, the necessary conditions for excluding duplicate cases are further analyzed to develop the deduplication strategy. The proposed method is developed based on open-source tools, i.e., NEZHA and TLS-diff. Three types of widely used TLS protocol implementations, i.e., OpenSSL, BoringSSL, and LibreSSL, are taken for experimental testing. The experimental results show that the proposed method can effectively improve the ability to find differences between different implementations. Under the same test scale or the same time, the amount of discrepancies increases by about 20% compared to TLS-diff, indicating the effectiveness of the deduplication strategy.
| S-EPMC8786154 | biostudies-literature
Project description:BackgroundThe Clinical Genome Resource (ClinGen) Electronic Health Record (EHR) Workgroup aims to integrate ClinGen resources with EHRs. A promising option to enable this integration is through the Health Level Seven (HL7) Infobutton Standard. EHR systems that are certified according to the US Meaningful Use program provide HL7-compliant infobutton capabilities, which can be leveraged to support clinical decision-making in genomics.ObjectivesTo integrate genomic knowledge resources using the HL7 infobutton standard. Two tactics to achieve this objective were: (1) creating an HL7-compliant search interface for ClinGen, and (2) proposing guidance for genomic resources on achieving HL7 Infobutton standard accessibility and compliance.MethodsWe built a search interface utilizing OpenInfobutton, an open source reference implementation of the HL7 Infobutton standard. ClinGen resources were assessed for readiness towards HL7 compliance. Finally, based upon our experiences we provide recommendations for publishers seeking to achieve HL7 compliance.ResultsEight genomic resources and two sub-resources were integrated with the ClinGen search engine via OpenInfobutton and the HL7 infobutton standard. Resources we assessed have varying levels of readiness towards HL7-compliance. Furthermore, we found that adoption of standard terminologies used by EHR systems is the main gap to achieve compliance.ConclusionGenomic resources can be integrated with EHR systems via the HL7 Infobutton standard using OpenInfobutton. Full compliance of genomic resources with the Infobutton standard would further enhance interoperability with EHR systems.
| S-EPMC5052552 | biostudies-literature
Project description:BackgroundThe SarQoL® questionnaire was specifically designed to measure quality of life (QoL) in sarcopenia. Frailty and sarcopenia have areas of overlap, notably weak muscle strength and slow gait speed, which may mean that the SarQoL could provide a measure of QoL in frailty. This study aimed to evaluate the clinimetric properties of the SarQoL questionnaire in physical frailty using the Fried criteria.MethodsAnalyses were carried out on data from the Sarcopenia and Physical impairment with advancing Age study. Frailty was assessed with the Fried criteria and QoL with the SarQoL, the Short-Form 36-Item, and the EuroQoL 5-Dimension (EQ-5D) questionnaires. We evaluated discriminative power (with the Kruskal-Wallis analysis of variance test), internal consistency (with Cronbach's alpha), construct validity (through hypotheses testing), test-retest reliability (with the intraclass correlation coefficient), measurement error (calculating standard error of measurement and smallest detectable change), and responsiveness (through hypotheses testing and standardized response mean).ResultsIn total, 382 participants were included for the validation and 117 for the responsiveness evaluation. They had a median age of 73 (69-79) years, took 5 (3-8) drugs, and had 4 (3-5) co-morbidities. There were more women (n = 223; 58.4%) than men and, in total, 172 (45%) robust, 167 (44%) pre-frail, and 43 (11%) frail participants. Discriminative power was confirmed when significantly lower (P < 0.001) overall SarQoL scores, and thus also worse QoL, were observed between robust [77.1 (64.35-85.90)], pre-frail [62.54 (53.33-69.57)], and frail [49.99 (40.45-56.06)] participants. Six of the SarQoL domains performed likewise, with significantly lower scores according to frailty status with Domain 7 (fears) being the exception. Internal consistency was good (α = 0.866). Convergent (using Short-Form 36-Item and EQ-5D) and divergent construct validity (using EQ-5D) was confirmed. Test-retest reliability was excellent [intraclass correlation coefficient = 0.918 (0.834-0.961)], with a standard error of measurement of 3.88 and a smallest detectable change of 10.76 points. We found moderate responsiveness when five of the nine hypotheses were confirmed, coupled with a large effect size for the overall SarQoL score (corrected standardized response mean of -1.44).ConclusionsThe SarQoL questionnaire has adequate clinimetric properties for use with frail patients in clinical practice and trials and could provide data that are more appropriate and detailed than the generic questionnaires currently used.
| S-EPMC8061363 | biostudies-literature
Project description:Global salinization trends present an urgent need for methods to monitor aquatic ecosystem health and characterize known and emerging stressors for water bodies that are becoming increasingly saline. Environmental metabolomics methods that combine quantitative measurements of metabolite levels and multivariate statistical analysis are powerful tools for ascertaining biological impacts and identifying potential biomarkers of exposure. We propose the use of the saltwater aquatic crustacean, Artemia franciscana, as a model organism for environmental metabolomics in saltwater ecosystems. Artemia are a good choice for ecotoxicity assays and metabolomics analysis because they have a short life cycle, their hemolymph is rich in metabolites and they tolerate a wide salinity range. In this work we explore the potential of Artemia franciscana for environmental metabolomics through exposure to the broad-spectrum herbicide, glyphosate. The LC50 for a 48 h exposure of Roundup® was determined to be 237 ± 23 ppm glyphosate in the Roundup® formulation. Artemia cysts were hatched and exposed to sub-lethal glyphosate concentrations of 1.00, 10.0, 50.0, or 100 ppm glyphosate in Roundup®. We profiled 48 h old Artemia extracts using 1H NMR and GC-MS. Dose-dependent metabolic perturbation was evident for several metabolites using univariate and multivariate analyses. Metabolites significantly affected by Roundup® exposure included aspartate, formate, betaine, glucose, tyrosine, phenylalanine, gadusol, and isopropylamine. Biochemical pathway analysis with the KEGG database suggests impairment of carbohydrate and energy metabolism, folate-mediated one-carbon metabolism, Artemia molting and development, and microbial metabolism.
| S-EPMC6581565 | biostudies-literature
Project description:IntroductionThe CIMZIA® AutoClicks® pre-filled pen (CZP PFP) was developed to overcome barriers to self-injection, by improving self-injection confidence, reducing fear associated with needle use, and supporting patients with impaired dexterity. The purpose of this research was to gather feedback on injection experience and the usefulness of training materials.MethodsEligible patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) were at least 18 years of age and initiated onto the CZP PFP. Routine self-injection training and support were provided by trained specialist nurses. Patient experience (pain and skin reactions, confidence, satisfaction, and ease of use) was evaluated at visits 1-3 using an amended version of the self-injection assessment questionnaire (SIAQ) v2.0. Nurse and patient feedback on the training materials, and nurse opinions on patient self-injection after self-injection at visit 1, were also collected.ResultsOf 355 patients invited to participate, 196 provided informed consent and 79 participated in all three visits. Patients generally found the CZP PFP easy to use, and self-confidence and satisfaction were high. From visit 1 to visit 3, there was a numerical trend towards improvement in all three aspects of patient experience, most notably in both confidence and satisfaction. After self-injection at visit 1, confidence around safe patient self-injection was higher among nurses than among patients. Meanwhile, "pain and skin reactions" remained low at all visits. Patients thought the training materials contained sufficient information and were easy to understand and useful.ConclusionAfter training, patients generally found the device easy to use and showed high confidence and satisfaction with self-injection. Some patients may have been competent (based on nurse opinion), but initially lacked self-confidence. Increasing self-injection experience, together with patient training and continued support, may have facilitated high patient confidence and satisfaction, thereby potentially overcoming some of the barriers to self-injection.
| S-EPMC7140744 | biostudies-literature