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Pragmatic Comparative Effectiveness Trials in Rheumatoid Arthritis-Associated Interstitial Lung Disease: A
Angela Kaczorowski-Worthley1, Dinesh Pal Mudaranthakam2, Janell Reichuber3
1University of Kansas School of Medicine, Kansas City, KS.
CHEST Pulmonary
|September 8, 2025
Summary
Experts and patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) support pragmatic trials using real-world and patient-reported outcomes. This approach could lower costs and improve patient-centered research for RA-ILD.
Area of Science:
- Rheumatology
- Pulmonology
- Clinical Trial Design
Background:
- Rheumatoid arthritis-associated interstitial lung disease (RA-ILD) has a poor prognosis, with limited treatment options and uncertain efficacy of current immunomodulatory and antifibrotic strategies.
- Developing effective clinical trials for RA-ILD is challenging due to high costs and the need for patient and expert input on feasibility and equipoise.
Purpose of the Study:
- To explore the perspectives of RA-ILD experts and patients regarding equipoise, feasibility, and optimal trial design for RA-ILD.
- To identify key considerations for developing patient-centered clinical trials in RA-ILD.
Main Methods:
- A qualitative study was conducted with 10 RA-ILD experts and 29 individuals with interstitial lung disease (or their caregivers) across 3 patient panels.
- Discussions were transcribed and analyzed using inductive coding to develop a thematic network.
Main Results:
- Experts emphasized treatment strategy variability, the importance of patient-reported outcomes, and balancing pragmatism with data collection in trial design.
- Patients highlighted crucial outcomes, barriers to participation, and the necessity of patient-centered research approaches.
Conclusions:
- Both expert and patient groups favored real-world clinical outcomes and patient-reported outcomes as primary endpoints in RA-ILD trials.
- Pragmatic trial designs are seen as a viable strategy to reduce costs, broaden eligibility, and enhance patient-centered research in RA-ILD.
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