Source-linked AI summary

Can JEV Support Clinical Trial Criteria Assessment?

Mengxian He, Ziyue Gao, Chun Li, Shunyi Zhang, Hao Wei, Minqing Zhang, Wu Yuan

arXiv:2610.35721v1cs.LGcs.AIcs.CL

TL;DR

Clinical trial prescreening must distinguish unmet conditions from insufficient evidence in patient records. This study compares JEV, a non-generative decision model, with schema-constrained Qwen Flash across three datasets and individual or shared-context batch assessments. Batch results were close on TrialGPT and MIMIC-IV, while JEV’s largest advantage was on MIMIC-III and concentrated in reference-unknown conditions.

  • Problem

    Prescreening requires distinguishing conditions that are unmet from those for which the patient record provides insufficient evidence, a judgment sensitive to clinical context, negation, and timing.

    Source: §1 · p. 1
  • Method

    The retrospective comparison evaluates JEV and schema-constrained Qwen Flash on 2,048 patient-condition pairs from TrialGPT and MIMIC-derived question-answer resources, using individual and shared-context batch requests.

    Source: §1 · p. 2, §2.4 · p. 4
  • Results

    JEV’s quality advantage depended on task and request configuration: its largest difference from Qwen was on MIMIC-III and concentrated in reference-unknown conditions, while Batch macro-F1 estimates were close on TrialGPT and MIMIC-IV.

    Source: §6 · p. 11
  • Takeaways & Limitations

    JEV can provide criterion-level decisions and label probabilities as an initial assessment, with potential information gaps followed up before screening decisions.

    Source: §1 · p. 2, §6 · p. 11

    MIMIC-IV’s insufficient-information results describe only the derived LVEF question family, because all 30 test references labeled INSUFFICIENT came from that question.

    Source: §3.3 · p. 6

Abstract

from arXiv · show

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; $\Delta$ = +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.

1 Introduction

Clinical trial prescreening must distinguish a condition that is unmet from one that the patient record does not establish, preserving information gaps for review. This section motivates JEV as a non-generative alternative and compares it with schema-constrained generative assessment.

1 Introduction

  • Prescreening must distinguish unmet conditions from insufficient evidence, since interpreting clinical statements depends on context, negation, and timing.A symptom may leave a criterion unresolved when its required duration is undocumented.Source: §1 · p. 1
  • Prior generative approaches include TrialGPT’s criterion-level predictions with explanations and sentence locations, and smaller LLMs trained through synthetic-data distillation.These studies motivate evaluating both judgment quality and resource use.Source: §1 · p. 1
  • JEV accepts patient context, natural-language questions, and predefined options, returning selected labels with native option probabilities.Source: §1 · p. 1
  • The relevant comparison is whether JEV matches schema-constrained models in classification, insufficient-evidence handling, latency, and cost.Criteria sharing a patient context can be assessed in a batch before clinical verification.Source: §1 · p. 2, Figure 1 · p. 2
  • The retrospective evaluation compares JEV with schema-constrained Qwen Flash on 2,048 patient-condition pairs across TrialGPT and question-answer resources derived from MIMIC-III and MIMIC-IV.It assesses conditions individually or in shared-context batches and measures classification, observed job latency, and estimated cost.Source: §1 · p. 2

2 Clinical Scenario and Model Interfaces

The evaluation assigns criterion-level labels to patient-condition pairs using JEV or schema-constrained Qwen, in individual or shared-context batch requests. JEV returns native option probabilities and a derived confidence score, while performance is assessed against source-derived reference labels without clinician revision.

2.1 Criterion-level assessment

  • Each patient-condition pair receives a label describing whether the stated condition holds, does not hold, remains unresolved, or does not apply; INSUFFICIENT concerns available evidence, not a confidence threshold.For an exclusion criterion, MET indicates that the disqualifying condition holds.Source: §2.1 · p. 3, Table 1 · p. 3

2.2 JEV: native decisions and option probabilities

  • For each question, JEV returns a selected label, probabilities over permitted labels, and a derived confidence score, but no explanatory rationale.For a fixed label set, confidence is an affine rescaling of the maximum option probability; probability diagnostics use the returned vector and selected-label probability.Source: §2.2 · p. 3

2.3 Qwen: schema-constrained label generation

  • Qwen receives the same patient text, policies, and label descriptions through a chat interface, with a strict JSON schema requiring one permitted label per condition.No comparable native class-probability vectors were recorded for Qwen.Source: §2.3 · p. 3

2.4 Single and Batch requests

  • Single mode submits each condition separately, whereas Batch submits a job’s questions together using a shared patient context.Both modes produce one label per condition; classification is measured at that level, while job latency covers the condition group.Source: §2.4 · p. 4

3 Benchmarks and Data Standardization

The benchmarks adapt TrialGPT and MIMIC-derived questions into criterion-level conditions, standardize source labels while retaining source-specific missing-information policies, and preserve existing dataset partitions.

3.1 Source tasks and retained conditions

  • TrialGPT retained 1,014 conditions; MIMIC-III retained 532 Boolean questions; MIMIC-IV retained 1,500 Boolean questions and derived 89 LVEF conditions for values ≤40%.Of 711 MIMIC-IV exclusions, 700 numerical questions lacked a verified conversion rule; 11 were excluded for a blank answer or out-of-range values.Source: §3.1 · p. 4

3.2 Reference-label mapping and interpretation

  • Source references were mapped to standardized assessment labels while preserving each source's policy for interpreting missing information.TrialGPT permits some clinically supported inferences from absent documentation, whereas MIMIC questions retain their specified scope, numerical boundary, and default rules.Source: §3.2 · p. 5

3.3 Grouping and retained partitions

  • The collection contains 3,135 conditions across development, primary test, and retained confirmation partitions, with existing partition assignments preserved.Primary analyses use 774 TrialGPT, 322 MIMIC-III, and 952 MIMIC-IV test conditions.Source: §3.3 · p. 5, Table 3 · p. 6
  • All 30 MIMIC-IV test references labeled INSUFFICIENT come from the derived LVEF question, limiting those results to that question family.Most MIMIC-III jobs contain one condition, leaving limited opportunity for sharing patient context across questions.Source: §3.3 · p. 6

4 Evaluation Protocol

The evaluation compares four single- and batch-mode configurations using the same patient text, questions, and label descriptions. It records responses and execution measures for subsequent analysis.

4.1 Comparison and execution

  • Four primary configurations were evaluated: JEV Single, JEV Batch, Qwen Single, and Qwen Batch.Each mode used the same frozen patient text, question-level assessment policies, and label descriptions, rendered through its model interface.Source: §4.1 · p. 6
  • Raw responses, status, token usage, and request- and job-level timing were recorded for subsequent analysis.The primary Qwen setup disabled thinking and used a 4,096-token completion limit; a separate batch experiment compared thinking off and on under an 8,192-token limit.Source: §4.1 · p. 7

5 Comparative Results

Across datasets, JEV’s quality advantage depends on the dataset and request mode: the largest gap is on MIMIC-III, while Batch scores are close on TrialGPT and MIMIC-IV. Batch timing and estimated costs favor JEV on all three test tracks, whereas added Qwen thinking raises resource use without a uniform quality benefit.

5.2 Single versus Batch

  • Switching JEV from Single to Batch changed correct test decisions by +5, −1, and +1 across the three datasets, while its macro-F1 changes were +0.64, −0.33, and −0.10 points, with all paired intervals including zero.Qwen Batch had +15, +5, and +21 net correct decisions and macro-F1 changes of +1.50, +1.14, and +8.22 points; on MIMIC-IV it corrected 48 Single errors but introduced 27 errors on previously correct conditions.Source: §5.2 · pp. 7–8
  • On MIMIC-IV, 13 of Qwen Batch’s corrections were among 30 reference-unknown conditions, with no damages in that class; one saved execution per mode cannot separate packaging effects from repeated-call variability.Source: §5.2 · p. 8

5.3 Thinking under matched settings

  • Thinking raised macro-F1 point estimates by 2.39 points on TrialGPT and 2.95 points on MIMIC-III, but lowered it by 2.89 points on MIMIC-IV; all paired intervals include zero.The matched test-only comparison also found complete-job median latency increases of 4.30, 2.33, and 3.08 times and estimated cost ratios of 1.94, 1.20–1.24, and 1.48 across TrialGPT, MIMIC-III, and MIMIC-IV, respectively.Source: §5.3 · pp. 8–9, Table 7 · p. 9

5.1 Overall criterion-level quality

  • JEV Single macro-F1 was 0.646/0.771/0.808 versus Qwen Single 0.645/0.523/0.732 across TrialGPT/MIMIC-III/MIMIC-IV; MIMIC-III Batch difference was +23.42 points (95% interval 18.73 to 28.05).Source: §5.1 · p. 7, Table 5 · p. 8, Figure 4 · p. 9

5.4 Cost and job timing

  • JEV Batch had lower observed median job latency than Qwen Batch on TrialGPT (1.20 versus 4.55 seconds), MIMIC-III (1.18 versus 2.80 seconds), and MIMIC-IV (1.40 versus 8.90 seconds).Estimated upper-bound costs per 1,000 conditions were USD 0.0170 versus 0.0645, 0.2045 versus 0.4314, and 0.0216 versus 0.0684, respectively; within JEV, Batch timing changed little on MIMIC-III, where 322 test conditions were distributed across 319 jobs.Source: §5.4 · pp. 9, 11, Figure 5 · p. 10

6 Conclusion

JEV’s quality advantage varies by task and request configuration, while its Batch latency and estimated cost are low in this retrospective benchmark. The authors position it for initial criterion-level assessment and information-gap flagging, with outputs checked against patient records before eligibility decisions.

  • JEV’s quality advantage is conditional on task and request configuration: its largest JEV–Qwen difference is on MIMIC-III and concentrated in reference-unknown conditions, while Batch macro-F1 point estimates are close on TrialGPT and MIMIC-IV.Source: §6 · p. 11
  • JEV’s native choice interface can provide criterion-level decisions and label probabilities at low observed Batch latency and estimated cost.Source: §6 · p. 11
  • Additional Qwen thinking increases resource use without a uniform quality gain in the matched comparison.Source: §6 · p. 11

A.1 All frozen partitions

The appendix reports native-label macro-F1 by frozen partition and a separate direction-aware TrialGPT endpoint; that endpoint answers a different scoring question from the native four-class task.

A.1 All frozen partitions

  • Native-label macro-F1 is reported by frozen partition, and all partitions were previously inspected; “confirmation” is a historical identifier.Source: Table 8 · p. 12

A.2 Paired model comparison

  • The direction-aware three-class TrialGPT endpoint had macro-F1 of 0.6388 for JEV Single, 0.6411 for JEV Batch, 0.6563 for Qwen Single, and 0.6526 for Qwen Batch.It merges insufficient information with failure to pass a condition, so its scores are not a performance change on the native four-class task.Source: §A.1 · p. 12

A.2 Paired model comparison

The paired comparison table reports JEV-minus-Qwen macro-F1 differences and 95% paired intervals, alongside net-correct counts; the Single-to-Batch table gives paired corrections and damages but does not establish repeated-call stability.

  • Paired model comparisons report JEV-minus-Qwen macro-F1 differences and their 95% paired intervals in percentage points, with net correct defined as corrections minus damages relative to Qwen.Source: Table 9 · p. 12
  • Single-to-Batch corrections and damages are paired counts, but these counts do not establish stability under repeated calls.Source: Table 10 · p. 13

A.3 Primary baseline resources

The primary test-resource materials report observed service measurements under differing acquisition conditions and retain additional aggregate usage, cost, latency, failure, and class-metric details.

A.3 Primary baseline resources

  • Table 11 reports estimated upper-bound cost per 1,000 planned conditions and observed timing and latency percentiles under different acquisition conditions.Terminal failures remain included in the timed/planned job counts.Source: Table 11 · p. 13
  • The aggregate materials retain exact usage, lower and upper cost bounds, tail latency, technical failure counts, and class metrics.Provider-reported reasoning tokens are included in output-token accounting, not charged a second time.Source: §A.3 · p. 13
  • The matched thinking test resource panel is reported separately and does not pool MIMIC test with confirmation.This preserves the separation between the MIMIC test and confirmation materials.Source: §A.3 · p. 13

A.4 Native probabilities and adapted family roles

This section describes native-probability diagnostics, adapted dataset roles, illustrative evidence-state errors, input-identity checks, and prompt and output policies. The examples and tables are bounded by their stated scope and do not constitute independent clinical adjudication.

A.4 Native probabilities and adapted family roles

  • Table 12 reports JEV native-probability diagnostics on historical test conditions, with calibration and high-confidence error metrics limited to valid vectors.The caption cautions that these values establish neither clinical risk thresholds nor a cross-model calibration ranking.Source: Table 12 · p. 14
  • Table 13 describes inherited MIMIC-IV adapted family roles, not independent clinical adjudications or complete protocol criteria.Source: Table 13 · p. 14
  • Table 14 summarizes historical test-split INSUFFICIENT-class errors, with precision, recall, F1, and directional confusion counts defined in its caption.These are benchmark label errors, not abstention decisions.Source: Table 14 · p. 15

A.6 Error Structure and Representative Cases

  • The eight purposively selected cases illustrate successes and failures against supplied labels, but do not estimate reasoning-mechanism prevalence.The cases compare the same frozen notes and target criteria across JEV Single and Batch and the historical non-thinking Qwen comparator.Source: §A.6 · p. 15, Table 15 · p. 15
  • In C1–C2, JEV preserves uncertainty for an unestablished history and matches the negative reference for an explicitly denied symptom, unlike Qwen.These examples distinguish missing historical evidence from an expressly denied symptom; the outputs do not reveal internal decision processes.Source: §A.6 · pp. 15, 17
  • In C4–C6, chronology and multi-component requirements expose disagreements: JEV returns INSUFFICIENT for C4 and matches that label in C6, while Qwen matches C4’s positive reference and returns MET in C6.For C5, JEV Single, JEV Batch, and Qwen Batch return the negative reference, while Qwen Single returns MET; these saved examples do not identify the cause of the numerical error.Source: §A.6 · p. 17
  • The C7 and C8 examples show mode and evidence-status disagreements, while one saved execution per mode cannot establish stability under repeated requests or rephrasing.For C7, only JEV Batch matches INSUFFICIENT; for C8, both Qwen modes match NOT_MET while both JEV modes return MET.Source: §A.6 · p. 17

A.7 Frozen input identities

  • The audit checked frozen input and reference identities and verified all 32 displayed predictions, while keeping restricted identifiers and clinical text outside the distributed package.The review used stored inputs, labels, and outputs without new model calls or clinician adjudication; examples were selected after outputs were observed.Source: §A.7 · p. 18, §A.6 · p. 18
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