Abstract
BACKGROUND: Knee osteoarthritis (KOA) is a chronic degenerative condition. Pain is the most prominent symptom of KOA, which can be exacerbated by obesity. The US Food and Drug Administration recommends using patient-reported outcome (PRO) measures to assess KOA pain and function in clinical trials, but none have been validated for patients with KOA and obesity/overweight. The objective of this study was to explore and document the patient experience of signs, symptoms, and health-related quality of life (HRQoL) impacts of KOA pain, including the impact of obesity/overweight, to facilitate future validation studies. METHODS: A targeted literature review and interviews with US participants with KOA pain (including some with comorbid obesity) were conducted. Publications and interview transcripts were analysed using content analysis methods to develop a conceptual model of KOA pain experience. RESULTS: Eighteen publications were reviewed and 25 participants were interviewed. All participants in the interviews reported knee pain and described that their physical functioning had been negatively affected. Many experienced a negative emotional/psychological impact. Many participants believed that there was a relationship between their weight and experience of KOA pain, reporting a 'vicious cycle' of pain and weight gain due to KOA. CONCLUSIONS: This study highlights the burden of living with KOA pain and the negative impact of obesity/overweight on patients' HRQoL. A conceptual model was developed, which may be used to explore the content validity of PRO measures and promote a robust understanding of the patient experience of living with KOA pain during the development of new therapies.