Core Outcome Domains for Elbow Replacement (CODER).

Aims: A review of the literature on elbow replacement found no consistency in the clinical outcome measures which are used to assess the effectiveness of interventions. The aim of this study was to define core outcome domains for elbow replacement.
Methods: A real-time Delphi survey was conducted over four weeks using outcomes from a scoping review of 362 studies on elbow replacement published between January 1990 and February 2021. A total of 583 outcome descriptors were rationalized to 139 unique outcomes. The survey consisted of 139 outcomes divided into 18 domains. The readability and clarity of the survey was determined by an advisory group including a patient representative. Participants were able to view aggregated responses from other participants in real time and to revisit their responses as many times as they wished during the study period. Participants were able to propose additional items for inclusion. A Patient and Public Inclusion and Engagement (PPIE) panel considered the consensus findings.
Results: A total of 45 respondents completed the survey. Nine core mandatory domains were identified: 'return to work or normal daily role'; delivery of care was measured in the domains 'patient satisfaction with the outcome of surgery' and 'would the patient have the same operation again'; 'pain'; 'revision'; 'elbow function'; 'independence in activities of daily living'; 'health-related quality of life'; and 'adverse events'. 'Elbow range of motion' was identified as important by consensus but was felt to be less relevant by the PPIE panel. The PPIE panel unanimously stated that pain should be used as the primary outcome domain.
Conclusion: This study defined core domains for the clinical outcomes of elbow replacement obtained by consensus from patients, carers, and healthcare professionals. Pain may be used as the primary outcome in future studies, where appropriate. Further work is required to define the instruments that should be used.
Competing Interests: A. C. Watts reports grants or contracts from NIHR, Zimmer Biomet, TRB Chemedica, and Stryker, royalties or licenses and patents planned, issued or pending from Adler, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Xiros, Medartis, and Arthrex, all of which are unrelated to this study. C. McDaid reports grants or contracts from NIHR HTA and i4i panels, research funding from Hull Teaching Hospitals NHS Trust, and is the co-director of NIHR RSS, all of which are unrelated to this study.
(© 2024 The British Editorial Society of Bone & Joint Surgery.)