A Real-Time Automated Patient Screening System for Clinical Trials Eligibility in an Emergency Department: Design and Evaluation
Bibliographic record
Abstract
BACKGROUND: One critical hurdle for clinical trial recruitment is the lack of an efficient method for identifying subjects who meet the eligibility criteria. Given the large volume of data documented in electronic health records (EHRs), it is labor-intensive for the staff to screen relevant information, particularly within the time frame needed. To facilitate subject identification, we developed a natural language processing (NLP) and machine learning-based system, Automated Clinical Trial Eligibility Screener (ACTES), which analyzes structured data and unstructured narratives automatically to determine patients' suitability for clinical trial enrollment. In this study, we integrated the ACTES into clinical practice to support real-time patient screening. OBJECTIVE: This study aimed to evaluate ACTES's impact on the institutional workflow, prospectively and comprehensively. We hypothesized that compared with the manual screening process, using EHR-based automated screening would improve efficiency of patient identification, streamline patient recruitment workflow, and increase enrollment in clinical trials. METHODS: The ACTES was fully integrated into the clinical research coordinators' (CRC) workflow in the pediatric emergency department (ED) at Cincinnati Children's Hospital Medical Center. The system continuously analyzed EHR information for current ED patients and recommended potential candidates for clinical trials. Relevant patient eligibility information was presented in real time on a dashboard available to CRCs to facilitate their recruitment. To assess the system's effectiveness, we performed a multidimensional, prospective evaluation for a 12-month period, including a time-and-motion study, quantitative assessments of enrollment, and postevaluation usability surveys collected from the CRCs. RESULTS: Compared with manual screening, the use of ACTES reduced the patient screening time by 34% (P<.001). The saved time was redirected to other activities such as study-related administrative tasks (P=.03) and work-related conversations (P=.006) that streamlined teamwork among the CRCs. The quantitative assessments showed that automated screening improved the numbers of subjects screened, approached, and enrolled by 14.7%, 11.1%, and 11.1%, respectively, suggesting the potential of ACTES in streamlining recruitment workflow. Finally, the ACTES achieved a system usability scale of 80.0 in the postevaluation surveys, suggesting that it was a good computerized solution. CONCLUSIONS: By leveraging NLP and machine learning technologies, the ACTES demonstrated good capacity for improving efficiency of patient identification. The quantitative assessments demonstrated the potential of ACTES in streamlining recruitment workflow and improving patient enrollment. The postevaluation surveys suggested that the system was a good computerized solution with satisfactory usability.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.072 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".