Development of International Classification of Functioning, Disability, and Health Core Sets for Lower Extremity Osteoarthritis within Indian Context: A Study Protocol

Abstract

Background: Properly understanding the functioning and health status of lower extremity osteoarthritis (LEOA) is needed to optimize interventions to enhance function and minimize disability. The available International Classification of Functioning, Disability, and Health (ICF) Core Sets (CS) for osteoarthritis are not specific to the lower extremity. They are strongly influenced by Western sociocultural values that may be inappropriate in the Indian context. Therefore, the objective of this study is to present the proposed process for the development of the ICF CS for LEOA, specifically for the Indian population. Materials and Methods: The first stage is to identify ICF categories significant for LEOA using four preparatory studies: (a) a systematic literature review to compile the researcher’s perspective by identifying functional outcome measures, (b) a qualitative study using focus group interviews to identify patients’ perspective, (c) an expert survey to identify experts’ perspective, and (d) a cross-sectional, multicenter study. The first version of the comprehensive and brief ICF-CS for LEOA will be developed through a consensus process using a Delphi exercise, integrating the evidence from the preparatory studies. In the final stage, field testing on Indian patients will validate the first version of the CS for LEOA. Conclusion: The proposed protocol to develop ICF-CS for LEOA may provide the basis for a generally agreed-upon standard that allows a comparison of functioning in clinical practice, research studies, quality management, and reimbursement that are relevant for patients with LEOA and health-care providers in Indian contexts.