ArticleTrials2014
A European inventory of common electronic health record data elements for clinical trial feasibility.
Article in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Big Data and Artificial Intelligence in Cancer Drug Discovery: Promise, Challenges, and Emerging Opportunities.Cancers · 2026Review
- Developing a Coordinated Registry Network for devices used for acute ischemic stroke intervention: basilar artery occlusion quality assessment pilot.Journal of neurointerventional surgery · 2025Article
- The Potential to Leverage Real-World Data for Pediatric Clinical Trials: A Proof-of-Concept Study.Journal of medical Internet research · 2025Article
- Reusing data from HL7 CDA-based shared EHR systems for clinical trial conduct: a method for analyzing feasibility.BMC medical informatics and decision making · 2025Article
- Building a Foundation for High-Quality Health Data: Multihospital Case Study in Belgium.JMIR medical informatics · 2024Article
- Clinical Research Informatics: a Decade-in-Review.Yearbook of medical informatics · 2024Review
- Parsing Clinical Trial Eligibility Criteria for Cohort Query by a Multi-Input Multi-Output Sequence Labeling Model.Proceedings. IEEE International Conference on Bioinformatics and Biomedicine · 2023Article
- ELaPro, a LOINC-mapped core dataset for top laboratory procedures of eligibility screening for clinical trials.BMC medical research methodology · 2022Article
- Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals.JMIR medical informatics · 2022Article
- Quality of Hospital Electronic Health Record (EHR) Data Based on the International Consortium for Health Outcomes Measurement (ICHOM) in Heart Failure: Pilot Data Quality Assessment Study.JMIR medical informatics · 2021Article
- Analysis of Not Structurable Oncological Study Eligibility Criteria for Improved Patient-Trial Matching.Methods of information in medicine · 2021Article
- Leveraging Real-World Data for the Selection of Relevant Eligibility Criteria for the Implementation of Electronic Recruitment Support in Clinical Trials.Applied clinical informatics · 2021Article
- Applied Practice and Possible Leverage Points for Information Technology Support for Patient Screening in Clinical Trials: Qualitative Study.JMIR medical informatics · 2020Article
- Identification of Common Data Elements from Pivotal FDA Trials.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2020Article
- Big data from electronic health records for early and late translational cardiovascular research: challenges and potential.European heart journal · 2018Review
- A conceptual framework for evaluating data suitability for observational studies.Journal of the American Medical Informatics Association : JAMIA · 2018Article
- Electronic health records to facilitate clinical research.Clinical research in cardiology : official journal of the German Cardiac Society · 2017Review
- Cross border semantic interoperability for learning health systems: The EHR4CR semantic resources and services.Learning health systems · 2017Article
- Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting.BMC medical research methodology · 2016Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinical studies are a necessity for new medications and therapies. Many studies, however, struggle to meet their recruitment numbers in time or have problems in meeting them at all. With increasing numbers of electronic health records (EHRs) in hospitals, huge databanks emerge that could be utilized to support research. The Innovative Medicine Initiative (IMI) funded project 'Electronic Health Records for Clinical Research' (EHR4CR) created a standardized and homogenous inventory of data elements to support research by utilizing EHRs. Our aim was to develop a Data Inventory that contains elements required for site feasibility analysis.
methodsThe Data Inventory was created in an iterative, consensus driven approach, by a group of up to 30 people consisting of pharmaceutical experts and informatics specialists. An initial list was subsequently expanded by data elements of simplified eligibility criteria from clinical trial protocols. Each element was manually reviewed by pharmaceutical experts and standard definitions were identified and added. To verify their availability, data exports of the source systems at eleven university hospitals throughout Europe were conducted and evaluated.
resultsThe Data Inventory consists of 75 data elements that, on the one hand are frequently used in clinical studies, and on the other hand are available in European EHR systems. Rankings of data elements were created from the results of the data exports. In addition a sub-list was created with 21 data elements that were separated from the Data Inventory because of their low usage in routine documentation.
conclusionThe data elements in the Data Inventory were identified with the knowledge of domain experts from pharmaceutical companies. Currently, not all information that is frequently used in site feasibility is documented in routine patient care.
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