A patient screening tool for clinical research based on Electronic Health Records Using openEHR (Preprint)

2021 ◽  
Author(s):  
Mengyang Li ◽  
Hailing Cai ◽  
Shan Nan ◽  
Jialin Li ◽  
Xudong Lu ◽  
...  
Keyword(s):  
Electronic Health Records ◽  
Clinical Research ◽  
Screening Tool ◽  
Eligibility Criteria ◽  
Health Records ◽  
Query Performance ◽  
Secondary Use ◽  
Patient Screening ◽  
Information Models ◽  
High Level

BACKGROUND The widespread adoption of electronic health records (EHRs) has facilitated the secondary use of EHR data for clinical research. However, screening eligible patients from EHR is a challenging task. The concepts in eligibility criteria are not completely matched with EHR, especially for “derived concepts”. The lack of high-level expression of SQL makes it difficult and time-consuming to express them. The openEHR Expression language (openEHR EL) as a domain-specific language based on clinical information models shows promise to represent complex eligibility criteria. OBJECTIVE The study aims to develop a patient screening tool based on EHR for clinical research using openEHR to solve concepts mismatch and improve query performance. METHODS A patient screening tool based on EHRs using openEHR is proposed. It utilizes the advantages of information models and expression language in openEHR to provide high-level expressions and improve query performance. Firstly, openEHR archetypes and templates were chosen to define concepts called “simple concepts” from EHR directly. After, openEHR EL was utilized to generate “derived concepts” by combining simple concepts and constraints. Third, a hierarchical index corresponding to archetypes in Elasticsearch was generated to improve query performance for subqueries and join queries related to “derived concepts”. Finally, on top of these works, we realized a patient screening tool for clinical research. RESULTS 500 sentences randomly selected from 4691 eligibility criteria in total 389 clinical trials about stroke from the Chinese Clinical Trial Registry (ChiCTR) were evaluated. An openEHR-based clinical data repository (CDR) in a Grade A tertiary hospital in China was considered as an experimental environment. Based on them, 589 medical concepts were found in these sentences. Among all of them, 513(87.1%) concepts can be represented, and the others cannot be represented because of a lack of information models and coarse-grained requirements. Also, our case study on 6 queries demonstrates our tool shows better query performance among 4 cases (66.67%). CONCLUSIONS We develop a patient screening tool using openEHR. It not only helps solve concepts mismatch but also improves the query performance to reduce the burden on researchers. Also, we demonstrate the promising solution for secondary use of EHR data using openEHR which can be referenced by other researchers.

A Framework for Systematic Assessment of Clinical Trial Population Representativeness Using Electronic Health Records Data

2021 ◽  
Vol 12 (04) ◽  
pp. 816-825
Author(s):  
Yingcheng Sun ◽  
Alex Butler ◽  
Ibrahim Diallo ◽  
Jae Hyun Kim ◽  
Casey Ta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Electronic Health Records ◽  
The United States ◽  
Design Stage ◽  
Common Data Model ◽  
Free Text ◽  
Eligibility Criteria ◽  
Health Records ◽  
Electronic Health

Abstract Background Clinical trials are the gold standard for generating robust medical evidence, but clinical trial results often raise generalizability concerns, which can be attributed to the lack of population representativeness. The electronic health records (EHRs) data are useful for estimating the population representativeness of clinical trial study population. Objectives This research aims to estimate the population representativeness of clinical trials systematically using EHR data during the early design stage. Methods We present an end-to-end analytical framework for transforming free-text clinical trial eligibility criteria into executable database queries conformant with the Observational Medical Outcomes Partnership Common Data Model and for systematically quantifying the population representativeness for each clinical trial. Results We calculated the population representativeness of 782 novel coronavirus disease 2019 (COVID-19) trials and 3,827 type 2 diabetes mellitus (T2DM) trials in the United States respectively using this framework. With the use of overly restrictive eligibility criteria, 85.7% of the COVID-19 trials and 30.1% of T2DM trials had poor population representativeness. Conclusion This research demonstrates the potential of using the EHR data to assess the clinical trials population representativeness, providing data-driven metrics to inform the selection and optimization of eligibility criteria.

Piloting the EHR4CR Feasibility Platform across Europe

2014 ◽  
Vol 53 (04) ◽  
pp. 264-268 ◽  
Author(s):  
R. Bache ◽  
M. McGilchrist ◽  
C. Daniel ◽  
M. Dugas ◽  
F. Fritz ◽  
...  
Keyword(s):  
Electronic Health Records ◽  
Clinical Research ◽  
Test Data ◽  
Data Access ◽  
Data Warehouses ◽  
University Hospitals ◽  
Local Networks ◽  
Health Records ◽  
Electronic Health ◽  
Set Up

SummaryBackground: Pharmaceutical clinical trials are primarily conducted across many countries, yet recruitment numbers are frequently not met in time. Electronic health records store large amounts of potentially useful data that could aid in this process. The EHR4CR project aims at re-using EHR data for clinical research purposes.Objective: To evaluate whether the protocol feasibility platform produced by the Electronic Health Records for Clinical Research (EHR4CR) project can be installed and set up in accordance with local technical and governance requirements to execute protocol feasibility queries uniformly across national borders.Methods: We installed specifically engineered software and warehouses at local sites. Approvals for data access and usage of the platform were acquired and terminology mapping of local site codes to central platform codes were performed. A test data set, or real EHR data where approvals were in place, were loaded into data warehouses. Test feasibility queries were created on a central component of the platform and sent to the local components at eleven university hospitals.Results: To use real, de-identified EHR data we obtained permissions and approvals from ‘data controllers‘ and ethics committees. Through the platform we were able to create feasibility queries, distribute them to eleven university hospitals and retrieve aggregated patient counts of both test data and de-identified EHR data.Conclusion: It is possible to install a uniform piece of software in different university hospitals in five European countries and configure it to the requirements of the local networks, while complying with local data protection regulations. We were also able set up ETL processes and data warehouses, to reuse EHR data for feasibility queries distributed over the EHR4CR platform.

scholarly journals Clinical Research Informatics: Contributions from 2017

2018 ◽  
Vol 27 (01) ◽  
pp. 177-183 ◽  
Author(s):  
Christel Daniel ◽  
Dipak Kalra ◽  
Keyword(s):  
Electronic Health Records ◽  
Clinical Research ◽  
Association Studies ◽  
Bias Reduction ◽  
Lessons Learned ◽  
Editorial Team ◽  
Private Industry ◽  
Health Records ◽  
Clinical Research Informatics ◽  
Electronic Health

Objectives: To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2017. Method: A bibliographic search using a combination of MeSH descriptors and free terms on CRI was performed using PubMed, followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the editorial team was organized to finally conclude on the selection of best papers. Results: Among the 741 returned papers published in 2017 in the various areas of CRI, the full review process selected five best papers. The first best paper reports on the implementation of consent management considering patient preferences for the use of de-identified data of electronic health records for research. The second best paper describes an approach using natural language processing to extract symptoms of severe mental illness from clinical text. The authors of the third best paper describe the challenges and lessons learned when leveraging the EHR4CR platform to support patient inclusion in academic studies in the context of an important collaboration between private industry and public health institutions. The fourth best paper describes a method and an interactive tool for case-crossover analyses of electronic medical records for patient safety. The last best paper proposes a new method for bias reduction in association studies using electronic health records data. Conclusions: Research in the CRI field continues to accelerate and to mature, leading to tools and platforms deployed at national or international scales with encouraging results. Beyond securing these new platforms for exploiting large-scale health data, another major challenge is the limitation of biases related to the use of “real-world” data. Controlling these biases is a prerequisite for the development of learning health systems.

scholarly journals Secondary Use of Electronic Health Records for Building Large, Real-World ILD Cohorts

2021 ◽  
Author(s):  
E.D. Farrand ◽  
O. Gologorskaya ◽  
H. Mills ◽  
L. Radhakrishnan ◽  
H.R. Collard ◽  
...  
Keyword(s):  
Electronic Health Records ◽  
Real World ◽  
Health Records ◽  
Secondary Use ◽  
Electronic Health

scholarly journals Diabetes and the direct secondary use of electronic health records: Using routinely collected and stored data to drive research and understanding

2018 ◽  
Vol 4 ◽  
pp. 205520761880465 ◽  
Author(s):  
Tim Robbins ◽  
Sarah N Lim Choi Keung ◽  
Sailesh Sankar ◽  
Harpal Randeva ◽  
Theodoros N Arvanitis
Keyword(s):  
Electronic Health Records ◽  
Missing Values ◽  
Research Output ◽  
Healthcare Research ◽  
Healthcare Sector ◽  
Diabetes Research ◽  
Health Records ◽  
Diverse Range ◽  
Secondary Use ◽  
Electronic Health

Introduction Electronic health records provide an unparalleled opportunity for the use of patient data that is routinely collected and stored, in order to drive research and develop an epidemiological understanding of disease. Diabetes, in particular, stands to benefit, being a data-rich, chronic-disease state. This article aims to provide an understanding of the extent to which the healthcare sector is using routinely collected and stored data to inform research and epidemiological understanding of diabetes mellitus. Methods Narrative literature review of articles, published in both the medical- and engineering-based informatics literature. Results There has been a significant increase in the number of papers published, which utilise electronic health records as a direct data source for diabetes research. These articles consider a diverse range of research questions. Internationally, the secondary use of electronic health records, as a research tool, is most prominent in the USA. The barriers most commonly described in research studies include missing values and misclassification, alongside challenges of establishing the generalisability of results. Discussion Electronic health record research is an important and expanding area of healthcare research. Much of the research output remains in the form of conference abstracts and proceedings, rather than journal articles. There is enormous opportunity within the United Kingdom to develop these research methodologies, due to national patient identifiers. Such a healthcare context may enable UK researchers to overcome many of the barriers encountered elsewhere and thus to truly unlock the potential of electronic health records.

scholarly journals Barriers and facilitators to data quality of electronic health records used for clinical research in China: a qualitative study

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029314 ◽  
Author(s):  
Kaiwen Ni ◽  
Hongling Chu ◽  
Lin Zeng ◽  
Nan Li ◽  
Yiming Zhao
Keyword(s):  
Qualitative Study ◽  
Electronic Health Records ◽  
Clinical Research ◽  
Data Quality ◽  
Healthcare Professionals ◽  
Barriers And Facilitators ◽  
Health Records ◽  
Improve Data Quality ◽  
Electronic Health

ObjectivesThere is an increasing trend in the use of electronic health records (EHRs) for clinical research. However, more knowledge is needed on how to assure and improve data quality. This study aimed to explore healthcare professionals’ experiences and perceptions of barriers and facilitators of data quality of EHR-based studies in the Chinese context.SettingFour tertiary hospitals in Beijing, China.ParticipantsNineteen healthcare professionals with experience in using EHR data for clinical research participated in the study.MethodsA qualitative study based on face-to-face semistructured interviews was conducted from March to July 2018. The interviews were audiorecorded and transcribed verbatim. Data analysis was performed using the inductive thematic analysis approach.ResultsThe main themes included factors related to healthcare systems, clinical documentation, EHR systems and researchers. The perceived barriers to data quality included heavy workload, staff rotations, lack of detailed information for specific research, variations in terminology, limited retrieval capabilities, large amounts of unstructured data, challenges with patient identification and matching, problems with data extraction and unfamiliar with data quality assessment. To improve data quality, suggestions from participants included: better staff training, providing monetary incentives, performing daily data verification, improving software functionality and coding structures as well as enhancing multidisciplinary cooperation.ConclusionsThese results provide a basis to begin to address current barriers and ultimately to improve validity and generalisability of research findings in China.

scholarly journals Intérêt des dossiers de santé électroniques hospitaliers pour la recherche clinique

2018 ◽  
Vol 34 (11) ◽  
pp. 972-977 ◽  
Author(s):  
Danielle Dupont ◽  
Ariel Beresniak ◽  
Dipak Kalra ◽  
Pascal Coorevits ◽  
Georges De Moor
Keyword(s):  
Electronic Health Records ◽  
Clinical Research ◽  
Qualité Des Soins ◽  
Health Records ◽  
Recherche Clinique ◽  
Electronic Health

Les dossiers de santé électroniques hospitaliers contribuent à l’amélioration de la qualité des soins en permettant une meilleure gestion des informations cliniques. Les bases de données numériques ainsi constituées facilitent l’échange des informations de santé avec les prestataires de soins et optimisent la coordination multidisciplinaire pour de meilleurs résultats thérapeutiques. Le projet européen EHR4CR (electronic health records for clinical research) a développé une plateforme pilote innovante permettant de réutiliser ces données numériques pour la recherche clinique. En améliorant et en accélérant les procédures de recherche clinique, cette approche permet d’envisager la réalisation d’études cliniques de manière plus efficiente, plus rapide et plus économique.

An XSLT Translator for the openEHR Archetype Definition Language

2017 ◽  
Author(s):  
John J. L. Chelsom
Keyword(s):  
Electronic Health Records ◽  
Patient Data ◽  
Specific Information ◽  
Health Record ◽  
Health Records ◽  
Information Models ◽  
Patient Health ◽  
Pipeline Processing ◽  
Open Standards ◽  
Iso 13606

The cityEHR Electronic Health Records system is a pure XML application for managing patient health records, using open standards. The structure of the health record follows the definition in the ISO 13606 standard, which is used in cityEHR as a basis for clinicians to develop specific information models for the patient data they gather for clinical and research purposes. In cityEHR these models are represented as OWL/XML ontologies. The most widely adopted approach to modelling patient data in accordance with ISO 13606 is openEHR, which uses its own Archetype Definition Language to specify the information models used in compliant health records systems. This paper describes a translator for the Archetype Definition Language, implemented using XSLT and XML pipeline processing, which generates OWL/XML suitable for use in cityEHR.

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