OA05 Consensus on a core domain set for foot and ankle disorders in rheumatic and musculoskeletal diseases: an international OMERACT Delphi consensus study

Abstract

Background/Aims Foot and ankle disorders are common in rheumatic and musculoskeletal diseases (RMDs), but there is a lack of high-quality evidence assessing the effectiveness of treatments for these disorders. A significant contributing factor is the heterogeneity of domains used across clinical trials to assess treatment effectiveness, hindering the ability to pool data in meta-analyses. The OMERACT Foot and Ankle Working Group is standardising domains to be measured and reported in all clinical trials for foot and ankle disorders in RMDs. Methods This was a modified Delphi consensus study, involving four rounds of online surveys. The first survey round consisted of a list of domains and their definitions, generated from the findings from previous literature reviews and qualitative interviews with 56 patients from eight countries. Following established OMERACT methodology, participants rated the importance of each domain on a scale of 1-9. In the second and third survey rounds, participants reviewed their own scores from the previous round alongside group responses (patients vs. HCPs/researchers), then re-rated each domain. Domain names and definitions were iteratively refined following participant feedback. Domains rated as critically important by ≥ 70% of both groups at the end of the third survey were taken into a final round, where each was rated as ‘in’ or ‘out’ of a mandatory core domain set. Circumstance-dependent core domains and domains for future consideration were agreed by the research team. Results A total of 126 participants (49 patients) from 15 countries completed all four survey rounds. The RMDs represented included rheumatoid arthritis, spondyloarthropathies, foot/ankle osteoarthritis, systemic lupus erythematosus, scleroderma, gout, and localised MSK disorders (e.g. Achilles tendinopathy). Five domains (pain intensity, pain when weightbearing, physical function (activities and participation), joint movement and treatment satisfaction were rated “in” by ≥ 70% participants and proposed as core domains (mandatory for all trials), two (structural pathology, healthcare expenses) were proposed as circumstance-dependent domains, and four (gait, footwear, emotional wellbeing and sleep) were deemed important for future consideration (Table 1). Conclusion This proposed core domain set will now go through endorsement by OMERACT. Further work is needed to identify appropriate outcome measurement instruments for each core domain. Disclosure L. Chapman: None. A. Redmond: None. T.O. Smith: None. C.A. Flurey: None. P. Richards: None. C. Hofstetter: None. H.B. Menz: None. M. Hannan: None. E. Soliman: None. J. Arnold: None. Y. Golightly: None. B. Shea: None. P.G. Conaghan: Consultancies; AbbVie/Abbott, Alfasigma, Eli Lilly, Enlivex, FormatoinBio, Genascence, Grunenthal, Kolon TissueGene, Levicept, Moebius, Novartis, Orion, Pacira, Stryker, Takeda. Member of speakers’ bureau; Novartis, Moebius, Kolon TissueGene, Eli Lilly, AbbVie/Abbott. P. Tugwell: None. S. Grosskleg: None. P. Helliwell: None. H. Siddle: Honoraria; Janssen.