An Intelligent Trial Eligibility Screening Tool Using Natural Language Processing With a Block-Based Visual Programming Interface: Development and Usability Study

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Publicado en:JMIR Medical Informatics vol. 13 (2025), p. e80072-e80086
Autor principal: Ya-Han, Hu
Otros Autores: Yi-Ying, Cheng, Chung-Ching, Lan, Yu-Hsiang, Su, Sheng-Feng, Sung
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JMIR Publications
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024 7 |a 10.2196/80072  |2 doi 
035 |a 3284805120 
045 2 |b d20250101  |b d20251231 
100 1 |a Ya-Han, Hu 
245 1 |a An Intelligent Trial Eligibility Screening Tool Using Natural Language Processing With a Block-Based Visual Programming Interface: Development and Usability Study 
260 |b JMIR Publications  |c 2025 
513 |a Journal Article 
520 3 |a Background:Clinical trial eligibility screening using electronic medical records (EMRs) is challenging due to the complexity of patient data and the varied clinical terminologies. Manual screening is time-consuming, requires specialized knowledge, and can lead to inconsistent participant selection, potentially compromising patient safety and research outcomes. This is critical in time-sensitive conditions like acute ischemic stroke. While computerized clinical decision support tools offer solutions, most require software engineering expertise to update, limiting their practical utility when eligibility criteria change.Objective:We developed and evaluated the intelligent trial eligibility screening tool (iTEST), which combines natural language processing with a block-based visual programming interface designed to enable clinicians to create and modify eligibility screening rules independently. In this study, we assessed iTEST’s rule evaluation module using pre-configured rules and compared its effectiveness with that of standard EMR interfaces.Methods:We conducted an experiment at a tertiary teaching hospital in Taiwan with 12 clinicians using a 2-period crossover design. The clinicians assessed the eligibility of 4 patients with stroke for 2 clinical trials using both standard EMR and iTEST in a counterbalanced order, resulting in 48 evaluation scenarios. The iTEST comprised a rule authoring module using Google Blockly and a rule evaluation module utilizing MetaMap Lite for extracting medical concepts from unstructured EMR documents and structured laboratory data. Primary outcomes included accuracy in determining eligibility. Secondary outcomes measured task completion time, cognitive workload using the National Aeronautics and Space Administration Task Load Index scale (range 0‐100, with lower scores indicating a lower cognitive workload), and system usability through the system usability scale (range: 0‐100, with higher scores indicating higher system usability).Results:The iTEST significantly improved accuracy scores (from 0.91 to 1.00, P<.001) and reduced completion time (from 3.18 to 2.44 min, P=.004) compared to the standard EMR interface. Users reported lower cognitive workload (National Aeronautics and Space Administration Task Load Index scale, 39.7 vs 62.8, P=.02) and higher system usability scale scores (71.3 vs 46.3, P=.01) with the iTEST. Particularly notable improvements in perceived cognitive workload were observed in temporal demand, effort, and frustration levels.Conclusions:The iTEST demonstrated superior performance in clinical trial eligibility screening, delivering improved accuracy, reduced completion time, lower cognitive workload, and better usability when evaluating preconfigured eligibility rules. The improved accuracy is critical for patient safety, as the misidentification of eligibility criteria could expose patients to inappropriate treatments or exclude them from beneficial trials. The adaptability and ability of the iTEST to process both structured and unstructured data make it valuable for time-sensitive scenarios and evolving research protocols. Future research should evaluate clinicians’ ability to create and modify eligibility rules using the block-based authoring interface, as well as assess the iTEST across diverse types of clinical trials and health care settings. 
610 4 |a National Aeronautics & Space Administration--NASA 
653 |a Patients 
653 |a Medical records 
653 |a Software 
653 |a Electronic health records 
653 |a Usability 
653 |a Stroke 
653 |a Experiments 
653 |a Medical research 
653 |a Laboratories 
653 |a Clinical trials 
653 |a Thrombolytic drugs 
653 |a Natural language processing 
653 |a Ischemia 
653 |a Workloads 
653 |a Documents 
653 |a Contraindications 
700 1 |a Yi-Ying, Cheng 
700 1 |a Chung-Ching, Lan 
700 1 |a Yu-Hsiang, Su 
700 1 |a Sheng-Feng, Sung 
773 0 |t JMIR Medical Informatics  |g vol. 13 (2025), p. e80072-e80086 
786 0 |d ProQuest  |t Healthcare Administration Database 
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