Core Outcome Domains For Elbow Replacement (CODER) Study

Abstract

Aim: A real-time Delphi consensus survey was undertaken to define a core outcome set for elbow replacement. Background(s): Elbow replacement is used to relieve pain and restore function in the management of arthritis conditions, acute trauma and trauma sequalae. A recent review of the literature on elbow replacement has found no consistency in clinical outcome measures used to assess the effectiveness of interventions. Method(s): A real-time Delphi survey was conducted over four weeks on Surveylet software (Calibrum, USA) using a list of outcomes from a scoping review of 362 studies on elbow replacement published between 1990 to 2021. 583 outcome descriptors extracted verbatim were rationalised to 139 unique outcomes. The survey consisted of 139 questions divided into 18 domains using the taxonomy of Dodd. Readability and clarity of the survey was determined by a survey advisory group including patients and carers, with preliminary piloting before roll-out to study participants. 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 which could be voted on by all participants. Result(s): Nine domains were identified as core mandatory domains for assessing elbow replacement. These were "return to work or normal daily role", delivery of care 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". An additional desirable domain, "elbow range of movement", was identified by consensus but not felt to be important by a Patient Public Involvement and Engagement (PPIE) panel. The mandatory and desirable time points for data collection were agreed. The PPIE panel unanimously agreed that pain should be used as the primary outcome measure. Conclusion(s): The study has defined core outcome 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 of elbow replacement where appropriate. Further work is required to define the instruments that should be used to measure these outcome domains.Copyright © 2024