(A-198) Use of International Classification of Functioning, Disability and Health in Randomized Control Trials in Rheumatoid Arthritis: a scoping review

Background: Rheumatoid arthritis (RA), are among the most common causes of disability worldwide. Its economic and social burden is substantial, impacting both individuals and society through reduced functioning, lost productivity, and increased healthcare costs. While randomized controlled trials (RCTs) primarily focus on clinical outcomes, they often overlook patients' functioning and well-being. The International Classification of Functioning, Disability, and Health (ICF) provides a standardized framework for assessing functioning, yet its use in RCTs remains limited.

Objectives: To systematically map the outcomes of RA in RCTs since 2010 and identify gaps in the integration of ICF into pharmacoepidemiologic research. Additionally, we will provide recommendations on how to effectively incorporate functioning data into RCTs and compare that with other tools used in this field.

Methods: A scoping review will be conducted following the PRISMA-ScR guidelines. The search will include studies published from 2010, when American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) establish criteria for earlier diagnosis of RA to February 2025 across multiple databases: MEDLINE, Embase, and ClinicalTrials.gov, duplicates will be removed. Eligible studies must be Phase III RCTs investigating treatments for rheumatic diseases. All identified publications will be screened by two independent reviewers for relevance.
Data extraction will focus on RCTs that include adult participants with rheumatoid arthritis (RA), examining both primary and secondary outcomes. Subsequently, we will assess the integration of the International Classification of Functioning, Disability, and Health (ICF) framework within these trials and propose ways to incorporate it as a secondary outcome measure in future research

Results: Preliminary findings suggest that while various patient-reported outcome measures align with ICF domains, direct use of the ICF framework in RCTs remains limited. The review will quantify the frequency usage result in domains under ICF, categorize its application in RA. Data will be presented in tabular and narrative formats to identify common themes and gaps in ICF implementation.

Conclusions: This scoping review will provide insight into the extent of ICF utilization in RCTs for RA. By identifying the benefits and burdens of using ICF as standardized measurement in RA, the findings will inform future research and advocate for the systematic inclusion of functioning data in clinical trials. Enhancing ICF integration can contribute to a more comprehensive evaluation of pharmacological interventions, bridging the gap between clinical efficacy and real-world patient functioning.