Reasoning Enrichment With Feedback From IA in NEphrology Trial
REFINe
Reasoning Enhancement With Feedback From a Generative AI in Nephrology (REFINe): A Randomized Evaluation of Generative AI Support in Nephrology Diagnosis
1 other identifier
interventional
100
1 country
1
Brief Summary
The goal of this clinical trial is to learn how artificial intelligence (AI) may help doctors make diagnoses in kidney medicine. The researchers want to know whether an AI tool called a large language model (LLM) can help doctors choose the correct diagnosis more often and feel more confident in their answers. Before starting the study, the research team tested several AI models and chose one of the best performers, a GPT-5-class model set to use high reasoning effort. The main questions this study aims to answer are:
- 1.Do doctors make more correct diagnoses when they can see AI suggestions?
- 2.Does seeing AI suggestions change how confident doctors feel about their diagnosis?
- 3.Read a short medical scenario
- 4.Suggest up to three possible diagnoses
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedStudy Start
First participant enrolled
November 20, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 20, 2026
January 1, 2026
12 months
November 19, 2025
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Final diagnostic accuracy (top-3) with vs without AI support
For each participant, proportion of vignettes where the correct main diagnosis is included in the participant's final top-3 diagnoses. Compare final top-3 accuracy between the AI arm (after AI suggestions) and the control arm (no AI). Percentage of correctly diagnosed cases (top-3).
From first vignette answered until the end of the study (up to 12 months).
Secondary Outcomes (12)
Final diagnostic accuracy (top-1) with vs without AI support
From first vignette answered until the end of the study (up to 12 months).
Change in top-3 diagnostic accuracy before vs after AI suggestions (AI arm only)
From first vignette answered until the end of the study (up to 12 months).
Change in top-1 diagnostic accuracy before vs after AI suggestions (AI arm only)
From first vignette answered until the end of the study (up to 12 months).
Diagnostic confidence (0-10) before AI suggestions: Control vs AI arm
From first vignette answered until the end of the study (up to 12 months).
Final diagnostic confidence (0-10) after AI suggestions: Control vs AI arm
From first vignette answered until the end of the study (up to 12 months).
- +7 more secondary outcomes
Study Arms (2)
Group with AI suggestions
EXPERIMENTALParticipants in this arm will complete the same clinical case vignettes as the control group. For each case, they will receive a suggested diagnosis generated by a large language model (GPT-5, high-reasoning configuration), which was selected after internal benchmarking. Participants can review the AI suggestion before entering their own final diagnostic answer. No additional information, prompts, or coaching is provided. The intervention consists solely of displaying the AI-generated diagnostic suggestion during the case-solving task.
Group without AI suggestions
NO INTERVENTIONParticipants in this arm will complete the clinical case vignettes independently, without any AI-generated diagnostic suggestions. They will read each vignette and provide their own diagnostic answer based solely on the information presented. No external decision support or additional materials are provided.
Interventions
This intervention consists of displaying an AI-generated diagnostic suggestion during the clinical case-solving task. After reading each vignette, participants see the top diagnostic proposal produced by a large language model (GPT-5, high-reasoning configuration), selected after internal benchmarking. The AI suggestion appears once per vignette and cannot be requested again or modified. Participants may revise their diagnostic answer after viewing the suggestion, but they cannot return to the vignette later. No additional guidance, coaching, or interactive features are provided.
Eligibility Criteria
You may qualify if:
- Adults aged 18 years or older.
- Able to read and answer clinical vignettes in English or French.
- Access to a computer or smartphone with an internet connection.
- Provides informed consent online.
- Participants are expected to have at least basic medical training (e.g., medical students, residents, fellows, or practicing clinicians), although no formal verification is required.
You may not qualify if:
- Individuals under 18 years of age.
- Inability to complete online study procedures.
- Prior involvement in the design, development, or evaluation of the AI system used in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Institut Pasteur de Lillecollaborator
- Lille Universitycollaborator
Study Sites (1)
Lille University Hospital (online study)
Lille, 59000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
November 19, 2025
First Posted
January 20, 2026
Study Start
November 20, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 20, 2026
Record last verified: 2026-01