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Evaluation of a Retrieval Augmented Large Language Model as a Diagnostic Copilot in Rheumatology

Evaluation of a Retrieval Augmented Large Language Model as a Diagnostic Copilot in Rheumatology

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07166692
Acronym
ALLIANCE
Enrollment
82
Registered
2025-09-10
Start date
2025-10-12
Completion date
2026-02-01
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis

Keywords

Clinical reasoning, Large language models, Computer-assissted diagnosis, Rheumatology

Brief summary

This trial evaluates whether providing physicians with access to Prof. Valmed, a clinical decision support medical product, improves identification of rheumatic diseases and formulation of differential diagnoses compared with conventional decision support.

Detailed description

Advanced AI, particularly large language models, shows promise for enhancing clinical reasoning, yet most systems such as ChatGPT are not certified as medical products. Prof. Valmed is a clinical decision support medical product designed to assist physicians in diagnostic decision making. Given frequent referral problems and diagnostic delays in rheumatology, evaluating such support is highly relevant for clinical workflows. This randomized controlled trial will test whether access to Prof. Valmed improves physicians' diagnostic performance in cases of suspected rheumatic disease compared with conventional decision support. Participants will be randomized to either use Prof. Valmed or rely on conventional tools while working through standardized clinical cases. For each case, participants will submit up to three differential diagnoses and a confidence rating. Independent reviewers, blinded to group allocation, will adjudicate accuracy. Findings will clarify the benefits and limitations of integrating Prof. Valmed into routine practice.

Interventions

OTHERProf. Valmed

Prof Valmed. decision support system.

Sponsors

Philipps University Marburg
Lead SponsorOTHER
University Medical Center Hamburg-Eppendorf (UKE)
CollaboratorUNKNOWN
Oslo University Hospital
CollaboratorOTHER
Diakonhjemmet Hospital
CollaboratorOTHER
University Hospital Erlangen
CollaboratorOTHER
Charite University, Berlin, Germany
CollaboratorOTHER
Rheumazentrum Ruhrgebiet
CollaboratorOTHER
University of Lausanne Hospitals
CollaboratorOTHER
Klinikum Fulda
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Masking description

The evaluation of responses will be performed by assessors blinded to participant identity and treatment assignment.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Participants must be licensed physicians. * Training in rheumatology, internal medicine, emergency medicine, family medicine, dermatology or orthopedics.

Exclusion criteria

* Not currently practicing clinically.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of top diagnosisdirectly (within 10 minutes) after InterventionParticipants in each group will make at least one disease suggestion (top diagnosis) and up to a total of a maximum of 3 suggestions. Percentage of exact matches of the top suggestion with the actual diagnosis will be analyzed

Secondary

MeasureTime frameDescription
Diagnostic accuracy of top 3 suggestionsdirectly (within 10 minutes) after InterventionParticipants in each group will make at least one disease suggestion (top diagnosis) and up to a total of a maximum of 3 suggestions. Percentage of exact matches with the actual diagnosis included in the top 3 suggestions will be analyzed
Diagnostic confidencedirectly (within 10 minutes) after InterventionFor each case participants will be asked for their diagnostic confidence (VAS 0-10). The mean score will be compared between groups.
Time spent for diagnosisdirectly (within 10 minutes) after InterventionWe will compare how much time (in seconds) participants spend per case between the two study arms.
Perceived Information Timelinessdirectly (within 10 minutes) after InterventionPerceived ability to receive the information needed without delay (Likert scale from 1 to 5)
Perceived diagnostic support qualitydirectly (within 10 minutes) after InterventionPerceived quality of the diagnostic support (Likert scale from 1 to 5)
Diagnostic reasoningduring evaluationFor each case, participants will receive 1 point for each plausible diagnosis and 2 points for a completely correct response. The total scores will be compared between the randomized groups.

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORJohannes Knitza, MD PhD

University Marburg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026