ArticleBMC medical research methodology2022
ELaPro, a LOINC-mapped core dataset for top laboratory procedures of eligibility screening for clinical trials.
Article in BMC medical research methodology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.
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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
5 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Common data models and data standards for tabular health data: a systematic review.BMC medical informatics and decision making · 2025Pooled it
- Electronic Health Record and Semantic Issues Using Fast Healthcare Interoperability Resources: Systematic Mapping Review.Journal of medical Internet research · 2024Pooled it
- LeafAI: query generator for clinical cohort discovery rivaling a human programmer.Journal of the American Medical Informatics Association : JAMIA · 2023Article
- Machine Learning-Enabled Clinical Information Systems Using Fast Healthcare Interoperability Resources Data Standards: Scoping Review.JMIR medical informatics · 2023Article
- A multicenter program for electronic health record screening for patients with heart failure with preserved ejection fraction: Lessons from the DELIVER-EHR initiative.Contemporary clinical trials · 2022Review
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundScreening for eligible patients continues to pose a great challenge for many clinical trials. This has led to a rapidly growing interest in standardizing computable representations of eligibility criteria (EC) in order to develop tools that leverage data from electronic health record (EHR) systems. Although laboratory procedures (LP) represent a common entity of EC that is readily available and retrievable from EHR systems, there is a lack of interoperable data models for this entity of EC. A public, specialized data model that utilizes international, widely-adopted terminology for LP, e.g. Logical Observation Identifiers Names and Codes (LOINC®), is much needed to support automated screening tools.
objectiveThe aim of this study is to establish a core dataset for LP most frequently requested to recruit patients for clinical trials using LOINC terminology. Employing such a core dataset could enhance the interface between study feasibility platforms and EHR systems and significantly improve automatic patient recruitment.
methodsWe used a semi-automated approach to analyze 10,516 screening forms from the Medical Data Models (MDM) portal's data repository that are pre-annotated with Unified Medical Language System (UMLS). An automated semantic analysis based on concept frequency is followed by an extensive manual expert review performed by physicians to analyze complex recruitment-relevant concepts not amenable to automatic approach.
resultsBased on analysis of 138,225 EC from 10,516 screening forms, 55 laboratory procedures represented 77.87% of all UMLS laboratory concept occurrences identified in the selected EC forms. We identified 26,413 unique UMLS concepts from 118 UMLS semantic types and covered the vast majority of Medical Subject Headings (MeSH) disease domains.
conclusionsOnly a small set of common LP covers the majority of laboratory concepts in screening EC forms which supports the feasibility of establishing a focused core dataset for LP. We present ELaPro, a novel, LOINC-mapped, core dataset for the most frequent 55 LP requested in screening for clinical trials. ELaPro is available in multiple machine-readable data formats like CSV, ODM and HL7 FHIR. The extensive manual curation of this large number of free-text EC as well as the combining of UMLS and LOINC terminologies distinguishes this specialized dataset from previous relevant datasets in the literature.
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