Набор по приглашению NCT07457840

Integrating AI Predictions With Clinician Expertise

Без фазы С лечением Diagnostic Decision Making

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Bayesian-Updated Post-Test Probability, Standard AI Predicted Probability, Uncertainty Quantification (95% Confidence Interval).
Кому может быть актуально: Состояния в реестре: Diagnostic Decision Making. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Transforming Clinical Decision Support Systems: Using Continuous Bayesian Updates to Integrate AI Predictions With Clinician Expertise

Обзор

Optimizing the interaction between the human and the machine is a major topic when deploying artificial intelligence (AI) at the bedside. The goal of this randomized clinical vignette study is to learn if presenting AI model outputs via continuous Bayesian updates and/or uncertainty quantification can improve diagnostic accuracy and clinician trust in healthcare professionals (physicians, residents, fellows, physician assistants (PAs), and nurse practitioners (NPs)) from US academic institutions evaluating patients with chest pain or dyspnea. The main questions it aims to answer are: * Does presenting AI predictions as Bayesian-updated post-test probabilities improve diagnostic accuracy compared to standard predicted probabilities? * Does the addition of uncertainty quantification (95% confidence intervals) to AI predictions improve diagnostic accuracy? * Do these interventions (Bayesian updating and/or uncertainty quantification) help clinicians recover from the negative effects of intentionally misleading AI predictions? Comparison: Researchers will compare standard AI predicted probabilities (presented without uncertainty) to Bayesian-updated post-test probabilities and/or outputs containing 95% confidence intervals to see if the interventions improve diagnostic accuracy, clinician confidence, and resilience against misleading AI. Participants will: * Review 8 clinical vignettes (simulated patient cases) focusing on chest pain or dyspnea. * Provide an initial "pre-test" diagnostic probability for 5 possible diagnoses based on the clinical history alone. * View AI model outputs that vary by experimental condition (standard probability vs. Bayesian update, with or without uncertainty intervals, and accurate vs. misleading). * Provide an updated "post-test" diagnostic probability for the diagnoses after viewing the AI output. * Select and rank diagnostic tests and therapeutic steps for each vignette. Complete a post-survey regarding their trust in the AI, comfort with the data presentation, and demographics.

Подробное описание

Study Design: This is a 2x2 factorial within-subjects design. The two factors are (1) Bayesian updating via continuous likelihood ratios (CLR) vs. standard predicted probability, and (2) uncertainty quantification (95% confidence intervals) vs. point estimate only. AI prediction accuracy (accurate vs. intentionally misleading) is varied as a within-subjects stratification factor balanced across all 4 conditions, with half of each participant's vignettes receiving accurate predictions and half receiving misleading predictions. AI predictions are simulated (pre-programmed) for experimental control. Vignette order and condition assignment are independently randomized per participant.

Primary Analysis: Diagnostic accuracy is analyzed using a generalized linear mixed model (GLMM) with fixed effects for CLR, Uncertainty, Misleading, and vignette, and a participant random intercept. Pre-specified secondary analyses examine interactions of presentation format with misleading AI.

Sample Size: Simulation-based power analysis (1,000 Monte Carlo iterations per scenario) was conducted using the planned GLMM. Assuming 70% baseline diagnostic accuracy and within-participant ICC of 0.25, the study achieves 85.8% power for the CLR main effect and 85.7% for the Uncertainty main effect with N=100 at alpha=0.05 (two-tailed).

Вмешательства

Поведенческое Bayesian-Updated Post-Test Probability
Rather than presenting the AI model's raw predicted probability, the system takes the clinician's pre-test probability (entered before seeing AI output) and applies a continuous likelihood ratio (CLR) derived from the AI model to calculate a Bayesian-updated post-test probability. The output is displayed as a shift from the clinician's own assessment (e.g., "Your assessment: 45% -\> Updated assessment: 72%"). The raw AI prediction is not shown. This approach mirrors how clinicians use diagnostic
Поведенческое Standard AI Predicted Probability
AI model prediction is presented as a simple predicted probability (0-100%) for each of the possible diagnoses, together with the top 3 clinical features driving the prediction (e.g., "Acute Myocardial Infarction: 68% - Key factors: elevated troponin, ST-segment changes on ECG, chest pain radiation to left arm"). This represents the most common current approach to presenting AI-based diagnostic predictions in clinical settings.
Поведенческое Uncertainty Quantification (95% Confidence Interval)
The AI output (whether Bayesian-updated post-test probability or standard predicted probability) is presented together with a 95% confidence band displayed as error bars on probability bars. For accurate AI predictions, confidence interval width is approximately +/-12-15 percentage points. For misleading AI predictions, confidence intervals are widened by a factor of 1.5x (approximately +/-18-23 percentage points) to simulate reduced model confidence in unfamiliar or edge-case scenarios. Confide

Первичные конечные точки

Clinician Diagnostic Accuracy [Срок оценки: Day 1 during survey completion]

Вторичные конечные точки (3)

Change in Diagnostic Probability Estimates [Срок оценки: Day 1 during survey completion]
Diagnostic Accuracy Under Misleading AI Predictions [Срок оценки: Day 1 during survey completion]
Clinician Satisfaction With AI Decision Support (Exploratory) [Срок оценки: Day 1 during survey completion]

Критерии участия

Критерии включения

Must hold one of the following clinical roles: Nurse Practitioner (NP), Physician Assistant/Physician Associate (PA), Resident Physician, Physician Fellow, or Attending Physician
Able to complete the survey in English
Access to a computer or tablet (mobile phones are not recommended due to the visual nature of the survey)