Can JEV Support Clinical Trial Criteria Assessment?
Organizations: The Chinese University of Hong Kong · Capital Medical University
Abstract
Clinical trial prescreening requires distinguishing unmet conditions from insufficient evidence in patient records. Given patient records, criterion questions, and predefined answer options, we retrospectively compared JEV, a non-generative decision model returning native option probabilities, with schema-constrained Qwen Flash across 2,048 test patient-condition pairs from TrialGPT and question-answer datasets derived from MIMIC-III and MIMIC-IV, all evaluated under strict Zero Data Retention (ZDR) policies to ensure clinical data privacy. Both models assessed conditions individually or in batches sharing the same patient context, with performance measured against reference labels. In batch mode, JEV and Qwen achieved similar macro-F1 scores on TrialGPT (0.652 vs. 0.660) and MIMIC-IV (0.807 vs. 0.814), whereas JEV substantially outperformed Qwen on MIMIC-III (0.768 vs. 0.534; = +0.234, 95% CI: 0.187-0.281). This advantage largely reflected higher recall for conditions labeled as having insufficient information (56.3% vs. 9.9%). Across all three datasets, JEV also had lower observed median job latency (1.18-1.40 vs. 2.80-8.90 s) and 53%-74% lower estimated cost per condition. These findings position JEV as an initial assessment component that provides criterion-level judgments and flags potential information gaps for review. JEV's observed errors in interpreting clinical evidence underscore the need to verify its outputs against patient records before they inform eligibility decisions.
Figures & tables
| Label | Meaning |
|---|---|
| met | The stated condition holds for the patient. |
| not_met | The stated condition does not hold under the specified policy. |
| insufficient | Required information is missing or unresolved under that policy. |
| not_applicable | The criterion does not apply to the patient or situation; TrialGPT only. |
| Source | Retained reference | Mapping or boundary |
|---|---|---|
| TrialGPT inclusion | included; not included | met ; not_met |
| TrialGPT exclusion | excluded; not excluded | met ; not_met |
| TrialGPT, either type | not enough information; not applicable | insufficient ; not_applicable |
| MIMIC Boolean | Available Yes or No | met or not_met ; preserve source defaults |
| MIMIC missing answer | Source unavailable flag and blank answer | insufficient ; inconsistent availability/answer pairs excluded |
| MIMIC-IV LVEF | Comparable lowest recorded value in percent | met if ; not_met otherwise. Source-valid capped range: . |
| Track | Groups | Jobs | Total | Dev | Test | Confirmation |
|---|---|---|---|---|---|---|
| TrialGPT | 53 | 105 | 1,014 | 240 | 774 | 0 |
| MIMIC-III | 522 | 529 | 532 | 105 | 322 | 105 |
| MIMIC-IV | 100 | 100 | 1,589 | 319 | 952 | 318 |
| Total | 675 | 734 | 3,135 | 664 | 2,048 | 423 |
| Track | Groups | Jobs | Conditions | M | N | U | A |
|---|---|---|---|---|---|---|---|
| TrialGPT | 43 | 85 | 774 | 129 | 366 | 243 | 36 |
| MIMIC-III | 314 | 319 | 322 | 83 | 97 | 142 | – |
| MIMIC-IV | 60 | 60 | 952 | 255 | 667 | 30 | – |
| Dataset | Mode | Accuracy | Macro-F1 | 95% CI | Failed | |
|---|---|---|---|---|---|---|
| TrialGPT | JEV Single | 774 | 0.720 | 0.646 | [0.594, 0.693] | 1 |
| TrialGPT | JEV Batch | 774 | 0.726 | 0.652 | [0.601, 0.702] | 0 |
| TrialGPT | Qwen Single | 774 | 0.730 | 0.645 | [0.590, 0.699] | 0 |
| TrialGPT | Qwen Batch | 774 | 0.749 | 0.660 | [0.602, 0.714] | 0 |
| MIMIC-III | JEV Single | 322 | 0.758 | 0.771 | [0.728, 0.812] | 0 |
| MIMIC-III | JEV Batch | 322 | 0.755 | 0.768 | [0.724, 0.811] | 1 |
| Dataset | Off F1 | On F1 | F1 (pp) | 95% CI (pp) | |
|---|---|---|---|---|---|
| TrialGPT | 774 | 0.677 | 0.701 | +2.39 | [-1.50, +6.74] |
| MIMIC-III | 322 | 0.531 | 0.560 | +2.95 | [-1.57, +7.35] |
| MIMIC-IV | 952 | 0.827 | 0.798 | -2.89 | [-6.10, +0.11] |
| Cost / 1,000 (USD) | Median job time (s) | |||
|---|---|---|---|---|
| Dataset | Off | On | Off | On |
| TrialGPT | 0.0645 | 0.1249 | 4.45 | 19.12 |
| MIMIC-III | 0.7264 | 0.8991 | 2.96 | 6.90 |
| MIMIC-IV | 0.0876 | 0.1299 | 8.65 | 26.66 |
Appendix figures & tables9 assets
Supplementary material from the paper’s appendix.
Appendix
| Dataset | Partition | JS | JB | QS | QB | |
|---|---|---|---|---|---|---|
| TrialGPT | Development | 240 | 0.748 | 0.749 | 0.749 | 0.779 |
| TrialGPT | Historical test | 774 | 0.646 | 0.652 | 0.645 | 0.660 |
| MIMIC-III | Development | 105 | 0.680 | 0.680 | 0.464 | 0.459 |
| MIMIC-III | Historical test | 322 | 0.771 | 0.768 | 0.523 | 0.534 |
| MIMIC-III | Confirmation | 105 | 0.814 | 0.804 | 0.602 | 0.637 |
| MIMIC-IV | Development | 319 | 0.813 | 0.816 | 0.722 | 0.838 |
| Dataset | Mode | Macro-F1 (pp) | 95% CI (pp) | Net correct |
|---|---|---|---|---|
| TrialGPT | Single | +0.05 | [-5.15, +5.08] | -8 |
| TrialGPT | Batch | -0.81 | [-5.73, +4.34] | -18 |
| MIMIC-III | Single | +24.89 | [+20.16, +29.62] | +68 |
| MIMIC-III | Batch | +23.42 | [+18.73, +28.05] | +62 |
| MIMIC-IV | Single | +7.66 | [+1.82, +13.39] | +13 |
| MIMIC-IV | Batch | -0.65 | [-4.24, +2.92] | -7 |
| Dataset | Model | Changed | Corrected | Damaged | Net | F1 (pp) |
|---|---|---|---|---|---|---|
| TrialGPT | JEV | 31 | 17 | 12 | +5 | +0.64 |
| TrialGPT | Qwen | 97 | 51 | 36 | +15 | +1.50 |
| MIMIC-III | JEV | 10 | 3 | 4 | -1 | -0.33 |
| MIMIC-III | Qwen | 28 | 11 | 6 | +5 | +1.14 |
| MIMIC-IV | JEV | 13 | 7 | 6 | +1 | -0.10 |
| MIMIC-IV | Qwen | 77 | 48 | 27 | +21 | +8.22 |
| Track | Arm | Timed/planned | Cost/1,000 | Req. P50 | Job P50 | Job P95 |
|---|---|---|---|---|---|---|
| TrialGPT | JEV Single | 85/85 | 0.0323 | 0.94 | 8.08 | 19.76 |
| TrialGPT | JEV Batch | 85/85 | 0.0170 | 1.05 | 1.20 | 1.58 |
| TrialGPT | Qwen Batch | 85/85 | 0.0645 | 4.55 | 4.55 | 8.12 |
| TrialGPT | Qwen Single | 85/85 | 0.0999 | 2.33 | 8.95 | 22.70 |
| MIMIC-III | JEV Single | 319/319 | 0.2064 | 1.09 | 1.19 | 1.49 |
| MIMIC-III | JEV Batch | 319/319 | 0.2045 | 1.08 | 1.18 | 1.44 |
| Track | Mode | Valid / planned | Brier | NLL | ECE | High- errors |
|---|---|---|---|---|---|---|
| TrialGPT | Single | 773/774 | 0.3787 | 0.8391 | 0.0475 | 19/195 |
| TrialGPT | Batch | 774/774 | 0.3756 | 0.8324 | 0.0336 | 20/196 |
| MIMIC-III | Single | 322/322 | 0.3615 | 0.9788 | 0.0974 | 20/174 |
| MIMIC-III | Batch | 320/322 | 0.3611 | 0.9044 | 0.0958 | 20/172 |
| MIMIC-IV | Single | 948/952 | 0.1565 | 0.5359 | 0.0376 | 19/549 |
| MIMIC-IV | Batch | 952/952 | 0.1556 | 0.5073 | 0.0346 | 19/560 |
| Role | Retained families | Scope limitation |
|---|---|---|
| Six inclusion-related components | Atrial fibrillation; prior stroke; heart failure; arterial hypertension; type 2 diabetes; derived LVEF | Source evidence covers only parts of protocol requirements, not every qualifier or the complete inclusion logic. |
| Ten contextual questions | Major depressive disorder; schizophrenia; bipolar disorder; hemorrhagic tendency; recent stroke; peptic ulcer disease; bleeding; atrial fibrillation ablation; surgical valvular disease; medical decision-making | Source questions differ from protocol gates in timing, required qualifiers, or meaning. A source-positive answer is not itself a disqualifying event. |
| Dataset | Arm | P (%) | R (%) | F1 (%) | U D | D U |
|---|---|---|---|---|---|---|
| TrialGPT | JEV Single | 63.2 | 67.1 | 65.1 | 75/243 | 85/495 |
| JEV Batch | 64.6 | 67.5 | 66.0 | 75/243 | 80/495 | |
| Qwen Single | 80.3 | 40.3 | 53.7 | 144/243 | 22/495 | |
| Qwen Batch | 81.5 | 49.0 | 61.2 | 122/243 | 25/495 | |
| MIMIC-III | JEV Single | 88.9 | 56.3 | 69.0 | 62/142 | 10/180 |
| JEV Batch | 88.9 | 56.3 | 69.0 | 61/142 | 10/180 |
| Case | Dataset | Evidence issue | Gold | JS | JB | QS | QB |
|---|---|---|---|---|---|---|---|
| C1 | MIMIC-III | Undocumented historical symptoms | U | U | U | N | N |
| C2 | MIMIC-III | Explicit negation across a symptom list | N | N | N | M | M |
| C3 | TrialGPT | Applicability versus nonfulfillment | A | N | N | N | N |
| C4 | MIMIC-III | Symptom onset before hospitalization | M | U | U | M | M |
| C5 | MIMIC-III | Laboratory values below a threshold | N | N | N | M | N |
| C6 | TrialGPT | Symptoms without required duration | U | U | U | M | M |
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