152 The OMERACT-OARSI core domain set for measurement in clinical trials of hip and/or knee osteoarthritis

Background: It has been over 20 years since the OMERACT core outcome set (COS) to measure in clinical trials with people who have hip and/or knee osteoarthritis (OA) was presented. An OMERACT-OARSI Working Group was established to update this COS using contemporary OMERACT methodologies. Methods: A review of the COMET database of COS was undertaken to identify all domains reported in previous COS that included individuals with hip and/or knee OA. These were presented in a series of patient and public (PP) meetings involving 70 individuals across the UK, Australia and Canada to review the domain list and identify additional important domains. Based on these, a three-round international Delphi survey was undertaken recruiting patients, health professionals, researchers and industry representatives, to gain consensus on key domains which should be included in this core domain set. Using the Delphi results, an OMERACT ‘onion’ was formulated with the following rules: Mandatory (core) Domains (mandatory for all trials) was defined as domains reported as ‘critical’ to assess by over 70% of Delphi responses in the patient AND others stakeholder groups Important but Optional Domains (recommended by optional in trials) was defined as domains reported as ‘critical’ to assess by over 70% of Delphi responses in the patient OR others stakeholder groups Research Agenda inclusion was defined as areas which need further research with insufficient evidence supporting the Important but Optional Domain group placement The findings were discussed at OMERACT2018 and a consensus vote was obtained on the core domain set. Results: From the COMET review, four previous COS were identified including the 1997 OMERACT core outcome set. These were reviewed across the PP meetings to identify 50 potential domains which formed the Delphi survey. In total 424 (217 patients; 207 non-patients) contributed data to the Delphi exercise from 25 different countries. The OMERACT2018 delegates (129 participants) voted on those domains which met the criteria for inclusion. Domains in the Mandatory (core) Domain group, to be measured and reported in all hip and/or knee OA clinical trials, included: ‘pain’, ‘physical function’, ‘quality of life’ and ‘patient global assessment of the target joint’ in addition to the mandated core domain of ‘adverse events including mortality’. ‘Joint structure’ was agreed as mandatory in specific circumstances, stating the specific circumstances, i.e. depending on the intervention. Domains in the Important but Optional Domains group included: ‘participation’, ‘psychosocial impact’, ‘sleep’ and ‘costs’ Domains in the Research Agenda group included: ‘clinician global assessment of target joint’, ‘flare’, ‘inflammation’, ‘cognitive function’, ‘fatigue’ and ‘impact on family/caregivers’. Conclusion: The updated core domain set for hip and/or knee OA has been agreed. We will now determine which instruments should be recommended to measure each of the mandatory (core) domains based on OMERACT guidance. Disclosures: T. Smith: Grants/research support; TS is supported by the National Institute for Health Research (NIHR) Biomedical Research Centre, Oxford. P.G. Conaghan: Consultancies; Abbvie, BMS, Flexion Therapeutics, GlaxoSmithKline, Kolon TissueGene, Medivird, Samumed, Roche, Pfizer, Novartis, Merck Serono. Grants/research support; PGC is supported, in part, by the NIHR Leeds Biomedical Research Centre.

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