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| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Oslo University Hospital | OTHER |
| Diakonhjemmet Hospital | OTHER |
| University Hospital Erlangen |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prof. Valmed | Experimental | Group will be given access to Prof. Valmed. |
|
| Control group | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prof. Valmed | Other | Prof Valmed. decision support system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of top diagnosis | Participants 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 | directly (within 10 minutes) after Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of top 3 suggestions | Participants 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 | directly (within 10 minutes) after Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Knitza, MD PhD | University Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Digital Medicine, University Hospital of Giessen and Marburg, Philipps University Marburg | Marburg | 35043 | Germany |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| Charite University, Berlin, Germany | OTHER |
| Rheumazentrum Ruhrgebiet | OTHER |
| University of Lausanne Hospitals | OTHER |
| Klinikum Fulda | OTHER |
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The evaluation of responses will be performed by assessors blinded to participant identity and treatment assignment.
| Diagnostic confidence |
For each case participants will be asked for their diagnostic confidence (VAS 0-10). The mean score will be compared between groups. |
| directly (within 10 minutes) after Intervention |
| Time spent for diagnosis | We will compare how much time (in seconds) participants spend per case between the two study arms. | directly (within 10 minutes) after Intervention |
| Perceived Information Timeliness | Perceived ability to receive the information needed without delay (Likert scale from 1 to 5) | directly (within 10 minutes) after Intervention |
| Perceived diagnostic support quality | Perceived quality of the diagnostic support (Likert scale from 1 to 5) | directly (within 10 minutes) after Intervention |
| Diagnostic reasoning | For 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. | during evaluation |