GenAI-Assisted Rheumatoid Arthritis Bone Erosion Risk Assessment and DMARD Selection

Condition(s) studied

Investigational drug(s) / intervention(s)

GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection: The intervention consists of a GenAI-generated clinical decision support report provided to treating physicians during routine RA care. Using patient clinical information available at the time of assessment, the GenAI system generates predicted bone erosion risk probabilities (0-100%), risk levels (0-3), and DMARD treatment recommendations. Physicians review the report after completing their independent pre-AI assessments and may revise their risk assessments and treatment decisions based on the additional information. The GenAI system provides decision support only and does not autonomously make or implement treatment decisions.

Study summary

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by progressive joint damage and bone erosion. Accurate assessment of RA bone erosion risk (RABER) and appropriate disease-modifying antirheumatic drug (DMARD) selection are critical to preventing irreversible disability.

Recent advances in generative artificial intelligence (GenAI), particularly large language models (LLMs), enable integration of heterogeneous clinical data and may improve clinical decision-making. However, there is limited real-world evidence (RWE) evaluating whether GenAI can meaningfully augment physician decision-making in routine care.

This prospective, single-arm, nonrandomized interventional study evaluates the feasibility and impact of GenAI-assisted clinical decision support on physician assessment of rheumatoid arthritis bone erosion risk and disease-modifying antirheumatic drug selection in routine inpatient care. Treating physicians document their initial risk assessments and treatment decisions before reviewing patient-specific GenAI reports and subsequently record their assessments and decisions after reviewing the reports. The study evaluates changes in physician clinical decision-making within a learning health system framework. Final treatment decisions remain under the responsibility of the treating physicians. The study does not evaluate long-term patient clinical outcomes.

Eligibility

Primary outcome measure(s)

• Percentage of Participants With a Change in Physician-Assessed Rheumatoid Arthritis Bone Erosion Risk Level After GenAI-Assisted Decision Support — During index hospitalization, at pre-AI and post-AI physician assessments (approximately 1-7 days)
  The percentage of participants for whom the treating physician changes the rheumatoid arthritis bone erosion risk level after reviewing the GenAI-generated clinical decision support report, compared with the initial assessment before reviewing the report. Risk levels are categorized from 0 to 3. A change is defined as any difference between the pre-AI and post-AI risk levels. The percentage is calculated using participants with complete paired assessments.
• Cohen's Kappa Agreement Between Physician-Assessed Rheumatoid Arthritis Bone Erosion Risk Levels and the Reference Standard Before and After GenAI-Assisted Decision Support — During index hospitalization, at pre-AI and post-AI physician assessments (approximately 1-7 days)
  Agreement between physician-assessed rheumatoid arthritis bone erosion risk levels (0-3) and the reference standard will be evaluated separately before and after review of the GenAI report using Cohen's kappa coefficient. The pre-AI and post-AI kappa coefficients will be compared to assess changes in agreement following GenAI-assisted decision support. Cohen's kappa ranges from -1 to 1, with higher values indicating greater agreement beyond chance. The difference between post-AI and pre-AI kappa coefficients will be reported, with positive values indicating improved agreement. The reference classification will be established during the data analysis stage by three independent expert physicians who are not involved in patient treatment, with disagreements resolved through consensus.

Trial sites (1)

More Guang'anmen Hospital of China Academy of Chinese Medical Sciences trials in China

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