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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:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Probability + No Uncertainty (Control) | Active Comparator | AI model prediction is presented as a standard predicted probability for each possible diagnosis (point estimate only), together with the top 3 clinical features driving the prediction. No confidence interval is shown. This is the control condition representing the most common current approach to presenting AI predictions in clinical settings. Within this arm, half of vignettes contain accurate AI predictions and half contain intentionally misleading predictions (balanced by design). |
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| Bayesian Updating (CLR) + No Uncertainty | Experimental | AI model prediction is used to perform Bayesian updating of the clinician's pre-test probability into a post-test probability using continuous likelihood ratios (CLR). The post-test probability is presented as a point estimate only, without a confidence interval. The raw AI predicted probability is not shown to the participant. Within this arm, half of vignettes contain accurate AI predictions and half contain intentionally misleading predictions (balanced by design). |
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| Standard Probability + Uncertainty (95% CI) | Experimental | AI model prediction is presented as a standard predicted probability for each possible diagnosis, together with the top 3 clinical features driving the prediction. The predicted probability is accompanied by a 95% confidence interval. Within this arm, half of vignettes contain accurate AI predictions and half contain intentionally misleading predictions (balanced by design). When AI predictions are misleading, confidence intervals are widened by a factor of 1.5x to simulate greater model uncertainty. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bayesian-Updated Post-Test Probability | Behavioral | 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 test results such as D-dimer to update pre-test probability of pulmonary embolism. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Diagnostic Accuracy | Proportion of correct diagnostic assessments across all vignettes and experimental conditions. For each vignette, participants rate 5 possible diagnoses on a 0-100% probability scale. The diagnosis assigned the highest probability is considered the participant's final diagnosis. Accuracy is determined by comparing the final diagnosis to the ground truth diagnosis established by expert panel consensus (minimum 4 of 5 board-certified physicians in agreement). Analyzed using a generalized linear mixed model (GLMM) with binary outcome (correct vs. incorrect), fixed effects for CLR, uncertainty quantification, misleading AI, and vignette, and a random intercept for participant. | Day 1 during survey completion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diagnostic Probability Estimates | Magnitude and direction of change in clinician-provided probability estimates from pre-test assessment (before AI output) to post-test assessment (after AI output) for each of 5 possible diagnoses per vignette. Measured on a 0-100% scale. | Day 1 during survey completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romain Pirracchio, MD, PhD, MPH | Contact | +1 (628) 246-3424 | romain.pirracchio@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Romain Pirracchio, MD, PhD, MPH | University of California, San Francisco | Principal Investigator |
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| ID | Term |
|---|---|
| D016001 | Confidence Intervals |
| ID | Term |
|---|---|
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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2x2 factorial within-subjects design.
Two interventions are crossed: (1) Bayesian updating via continuous likelihood ratios (CLR) vs. standard predicted probability, and (2) uncertainty quantification (95% CI) vs. point estimate only.
Each participant reviews 8 clinical vignettes, with each vignette assigned to one of the 4 factorial conditions. AI prediction accuracy is varied as a stratification factor: half of each participant's vignettes receive accurate AI predictions and half receive intentionally misleading predictions, balanced across all 4 conditions. This tests whether the presentation formats help clinicians resist incorrect AI. Vignette order and condition assignment are randomized per participant. AI predictions are simulated (pre-programmed) for experimental control.
Primary analysis: main effects of CLR and uncertainty on diagnostic accuracy via generalized linear mixed model. Secondary analyses: interaction of presentation format with misleading AI.
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| Bayesian Updating (CLR) + Uncertainty (95% CI) | Experimental | AI model prediction is used to perform Bayesian updating of the clinician's pre-test probability into a post-test probability using continuous likelihood ratios (CLR). The post-test probability is presented with a 95% confidence interval. The raw AI predicted probability is not shown to the participant. This arm represents the full intervention combining both candidate approaches. Within this arm, half of vignettes contain accurate AI predictions and half contain intentionally misleading predictions (balanced by design). When AI predictions are misleading, confidence intervals are widened by a factor of 1.5x to simulate greater model uncertainty. |
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| Standard AI Predicted Probability | Behavioral | 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. |
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| Uncertainty Quantification (95% Confidence Interval) | Behavioral | 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. Confidence intervals are constrained to the 0-100% range. |
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| Diagnostic Accuracy Under Misleading AI Predictions |
Proportion of correct final diagnoses when AI predictions are intentionally misleading vs. accurate, and whether the interventions (Bayesian updating, uncertainty quantification) mitigate the negative effect of misleading AI. Assessed via interaction terms (CLR x Misleading, Uncertainty x Misleading) in the primary GLMM. |
| Day 1 during survey completion |
| Clinician Satisfaction With AI Decision Support (Exploratory) | Self-reported satisfaction with the AI-based clinical decision support, measured via question(s) in the post-survey questionnaire. | Day 1 during survey completion |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |