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| Name | Class |
|---|---|
| Technical University of Denmark | OTHER |
| The Foundation of 17.12.1981 | OTHER |
| Department of Computer Science, University of Copenhagen, Denmark | UNKNOWN |
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The goal of this randomized questionnaire-based study is to evaluate how different presentations of artificial intelligence (AI) decision support influence clinical judgment among medical doctors working in obstetrics and gynecology when assessing the risk of spontaneous preterm birth using clinical case vignettes with cervical ultrasound images. The study specifically compares two AI presentation formats: a binary classification (preterm vs term birth) and an individualized risk estimate of preterm birth.
The main questions it aims to answer are:
Participants will complete an online questionnaire in which they review clinical cases, make diagnostic and management decisions, rate their diagnostic confidence before and after seeing the AI output, and report their trust in the AI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI prediction | Experimental | The participants receive a binary AI prediction (preterm or term birth) |
|
| AI risk estimate | Experimental | The participants receive an AI risk estimate of preterm birth (%) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI prediction (binary) | Behavioral | AI decision support based on cervical ultrasound providing a binary classification (preterm birth before 37 weeks or term birth) in addition to standard clinical information. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician diagnostic calibration (accuracy-confidence alignment) after AI exposure. | Agreement between post-AI decision correctness (0/1) and post-AI confidence rating (0-10) will be quantified using the Brier score. Confidence will be rescaled to 0-1 and squared differences between confidence and correctness will be averaged across cases to produce a participant-level score. Lower scores indicate better diagnostic calibration. Results will be compared between randomized arms. | Immediately after AI exposure during a single questionnaire session (approximately 20 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Helpful switch rate and harmful switch rate. | Proportion of cases with helpful and harmful switches calculated for each participant and compared between study arms. Helpful switch = incorrect pre-AI decision changing to correct post-AI decision. Harmful switch = correct pre-AI decision changing to incorrect post-AI decision. | Baseline (pre-AI) and immediately after AI exposure during a single questionnaire session (approximately 20 minutes). |
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Inclusion Criteria:
Exclusion Criteria:
- No prior experience performing transvaginal cervical ultrasound examinations.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Pi F Sejer, MD | Contact | 0045 28890690 | emilie.pi.fogtmann.sejer.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Martin G Tolsgaard, MD, PhD, DMSc | Department of Obstetrics and Gynecology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Jutland Hospital | Recruiting | Aabenraa | 6200 | Denmark |
Individual participant data are not planned to be publicly shared. Aggregate results will be reported. De-identified data may be made available upon reasonable request and subject to institutional policies and applicable data protection regulations.
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| Copenhagen Academy for Medical Education and Simulation |
| OTHER |
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Participants (clinicians) are blinded to randomized allocation and are unaware that different versions of the AI decision support are being compared. They view only the AI output presented within their assigned condition. No independent outcome assessors are involved. Outcomes are derived using pre-specified, objective scoring rules.
| AI risk estimate (%) | Behavioral | AI decision support based on cervical ultrasound providing an estimate of preterm birth risk (%) in addition to standard clinical information. |
|
| Change in decision accuracy, confidence, and diagnostic calibration from pre-AI to post-AI. | Within-participant change from pre-AI to post-AI in decision accuracy (proportion of correct decisions), confidence rating, and diagnostic calibration. Differences will be compared between randomized arms and stratified by AI correctness. | Baseline (pre-AI) and immediately after AI exposure during a single questionnaire session (approximately 20 minutes). |
| Association between self-rated trust in AI and behavioral reliance on AI. | Self-rated trust in the AI output will be measured using a numeric rating scale (0-10) after AI exposure for each case. Behavioral reliance will be quantified as the proportion of post-AI decisions concordant with the AI output. The relationship between trust ratings and behavioral reliance, including concordance when the AI is correct and incorrect, will be evaluated at the participant level and compared between randomized arms. | Immediately after AI exposure during a single questionnaire session (approximately 20 minutes). |
| Follow-up cervical ultrasound planning. | Proportion of cases in which clinicians plan an additional cervical ultrasound (yes/no), summarized per participant and compared pre-post AI and between randomized arms. | Baseline (pre-AI) and immediately after AI exposure during a single questionnaire session (approximately 20 minutes). |
| Aalborg University Hospital (Aalborg and Thisted) | Recruiting | Aalborg | 9000 | Denmark |
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| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| Copenhagen University Hospital, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| Esbjerg Hospital | Recruiting | Esbjerg | 6700 | Denmark |
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| Gødstrup Regional Hospital | Recruiting | Gødstrup | 7400 | Denmark |
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| Herlev Hospital | Recruiting | Herlev | 2730 | Denmark |
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| Copenhagen University Hospital, North Zealand | Recruiting | Hillerød | 3400 | Denmark |
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| Region Hospital North Jutland | Recruiting | Hjørring | 9800 | Denmark |
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| Holbæk Hospital | Recruiting | Holbæk | 4300 | Denmark |
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| Horsens Regional Hospital | Recruiting | Horsens | 8700 | Denmark |
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| Hvidovre Hospital | Recruiting | Hvidovre | 2650 | Denmark |
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| Kolding Hospital | Recruiting | Kolding | 6000 | Denmark |
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| Odense University Hospital (Odense and Svendborg) | Recruiting | Odense | 5000 | Denmark |
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| Randers Regional Hospital | Recruiting | Randers | 8930 | Denmark |
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| Zealand University Hospital (Roskilde and Nykøbing F.) | Recruiting | Roskilde | 4000 | Denmark |
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| Slagelse Hospital | Recruiting | Slagelse | 4200 | Denmark |
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| Viborg Regional Hospital | Recruiting | Viborg | 8800 | Denmark |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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