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

P

Philipps University Marburg

Status

Not yet enrolling

Conditions

Diagnosis

Treatments

Other: Prof. Valmed

Study type

Interventional

Funder types

Other

Identifiers

NCT07166692
24-221-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

82 participants in 2 patient groups

Prof. Valmed
Experimental group
Description:
Group will be given access to Prof. Valmed.
Treatment:
Other: Prof. Valmed
Control group
No Intervention group
Description:
Group will not be given access to Prof. Valmed but will be encouraged to use any resources they wish besides large language models (UpToDate, etc).

Trial contacts and locations

1

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Central trial contact

Johannes Knitza, MD PhD MHBA

Data sourced from clinicaltrials.gov

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