POS0269-HPR CONTENT VALIDITY OF A MULTIPLE LANGUAGES QUESTIONNAIRE FOR MEASURING FLARE IN KNEE AND HIP OA: DEVELOPMENT OF THE FLARE-OA

Abstract

Background:Flare in osteoarthritis (OA) of the knee and hip (KHOA) is an important outcome for patients’ daily life and clinical research. A definition of a flare was set, and a core set of domains was recently endorsed by OMERACT/OARSI. No patient reported outcome (PRO) yet focusses on flare in OA specifically.Objectives:To develop a self-reporting instrument measuring flare in 5 languages, using qualitative methods and international Delphi consensus.Methods:We generated items using a dual-language (English and French) approach involving patients with OA from Australia, France and the United States and health care professionals (HCP) from international societies (OARSI, SFR, OMERACT). Item generation relied on semi-structured individual interviews conducted with OA patients and HCP and one focus group with patients. Content analysis allowed for identifying verbatim statements that were meaningful for patients and HCP. A Delphi consensus method was used to select the most relevant items, according to core domains set (OMERACT). A cross-cultural approach using current guidelines (1) was applied to produce Spanish (in Spain), Turkish and classical Arabic (in Morocco) versions using independent translation and expert committee to preserve its content validity.Results:From semi-structured interviews with 29 patients and 16 HCPs and one focus group with 10 patients, 180 statements in French (106) and English (77) were generated. Based on similarity or redundancy, 50 items with equivalent meaning in both languages were retained by an expert committee. After two Delphi rounds involving 50 patients and 116 HCPs from 17 countries on four continents, it was reduced to 33 items (response 0=not at all, to 10=absolutely) in five domains (pain, swelling, stiffness, consequences of symptoms and psychological aspects). This questionnaire was cross-culturally adapted into Spanish, Turkish and classical Arabic. The Spanish version uncovered one inappropriate item in the original questionnaire that was amended accordingly in all 5 languages.Conclusion:Flare is more than just an exacerbation of pain. The Flare-OA questionnaire includes all OMERACT recommended core domains. High content validity was seen in 2 original and 3 cross-culturally adapted languages. The Flare-OA should be considered as fit for purpose and evaluation of responsiveness in clinical studies in 5 languages.Disclosure of Interests:None declared