跳至主要内容
临床试验/NCT07179861
NCT07179861已完成不适用

A Prospective, Cross-Sectional, Vignette-Based Observational Study Comparing Clinical Decision-Making Performance of Pediatriciansand AI Models

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月27日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
AI Interpretation Accuracy (%)

研究概览

简要总结

This study evaluates how well anonymized artificial-intelligence (AI) tools perform on standardized pediatric case vignettes and whether showing AI suggestions can improve clinicians' answers. About 30 board-certified/eligible pediatric specialists at a single hospital complete a one-time session. Participants are randomized to two groups. Group A (n≈15): physicians answer each vignette once. Group B (n≈15): physicians answer and rate confidence (1-10), then review anonymized suggestions from five different AI tools (tool names not shown) and may keep or change their answer; changes and confidence are recorded.

Primary focus: measure AI performance (diagnostic accuracy, medication-dosing accuracy, interpretation accuracy) overall and by difficulty tier, and record AI response time. Secondary focus: quantify how AI suggestions affect human performance (change in accuracy, direction of change, confidence shift, and time). No patients or biospecimens are involved; risks are minimal (time and possible discomfort with performance review). Findings may inform safe, evidence-based ways to use AI alongside clinicians in pediatrics.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
28 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Board-certified or board-eligible pediatric specialist (general pediatrics) (in the first 10 years of expertise)
  • Actively practicing at the participating institution/network at the time of enrollment.
  • Able and willing to complete all vignette items individually in a single session and to follow study instructions for the assigned cohort (direct answers or confidence rating + viewing anonymized AI suggestions).
  • Fluent in Turkish and able to use a computer interface.
  • Provides written informed consent.

排除标准

  • Pediatric subspecialist practice as primary role (e.g., cardiology, infectious diseases, neurology, neonatology, etc.), to maintain a homogeneous general pediatrics cohort.
  • Prior access to or participation in creating the study vignettes, answer keys, or scoring rubrics; direct involvement with the study team.
  • Inability to complete the session without external help or use of non-protocol resources (internet/AI tools) during answering (outside of anonymized AI suggestions shown by the system in Group 2).
  • Failure to complete ≥90% of items or major protocol deviation (e.g., discussion with others during the task).
  • Any condition judged by investigators to interfere with valid participation (e.g., severe time constraints, inability to provide consent).

结局指标

主要结局

AI Interpretation Accuracy (%)

时间窗: Day 1

Proportion of correct laboratory/imaging interpretations or appropriate next-test selections, per AI tool and pooled; stratified by difficulty tier. Unit: percent (0-100).

AI Diagnostic Accuracy (%)

时间窗: Day 1

Proportion of vignettes with a correct primary diagnosis produced by each anonymized AI tool and pooled across tools. Correctness is defined against a pre-specified reference answer key; results are also stratified by pre-defined difficulty tiers (easy/moderate/difficult/very difficult). Unit of measure: percent (0-100).

AI Medication-Dosing Accuracy (%)

时间窗: Day 1

Proportion of dose recommendations meeting pediatric standards (weight- or BSA-based ranges, route, frequency) per reference rubric, per AI tool and pooled; stratified by difficulty tier. Unit: percent (0-100).

次要结局

  • Change in Physician Diagnostic Accuracy (percentage points) (Group 2 only)(Day 1: Baseline (pre-AI) and immediate Post-AI within the same session (0-15 min after baseline).)
  • Confidence Shift (Δ on a 1-10 scale) (Group 2 only)(Day 1: Baseline (pre-AI) and immediate Post-AI within the same session (0-15 min after baseline).)
  • Answer-Change Frequency (%) (Group 2 only)(Day 1)
  • AI Response Time (seconds per vignette)(Day 1)
  • Net Benefit Index of AI Exposure (percentage points) (Group 2 only)(Day 1)

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berker Okay

MD - Pediatrician (Principal Investigator)

Haseki Training and Research Hospital

研究点 (1)

Loading locations...

相似试验