Core Outcome Domains - Elbow Replacement (CODER) version 1
Research type
Research Study
Full title
Core Outcome Domains - Elbow Replacement (CODER) A Real-Time Delphi Questionnaire
IRAS ID
320243
Contact name
Adam Watts
Contact email
Sponsor organisation
Wrightington Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
COMET initiative, 2132
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
Elbow replacement is used to relieve pain and restore function in the management of arthritis conditions, acute trauma and trauma sequelae. A review of the literature on elbow replacement has found no consistency in clinical outcome measures used to assess the effectiveness of interventions. The aim of this study therefore was to define a core outcome set for elbow replacement.
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 important domain, “elbow range of movement”, was identified by consensus but was felt to be less relevant by a Patient Public Involvement and Engagement (PPIE) panel. The mandatory and important time points for data collection were agreed. The PPIE panel unanimously agreed that pain should be used as the primary outcome domain.
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.
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.comet-initiative.org%252FStudies%252FDetails%252F2692%2FNBTI%2FtWzEAQ%2FAQ%2F9833b69f-8244-4c0c-bf17-0adc5f1f5da1%2F2%2F-r4KAQW4gz&data=05%7C02%7Criverside.rec%40hra.nhs.uk%7Cad65203493104da2d2c408de9090c2ff%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639107148614854107%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=0Bi1i4ABNh9znSrLe5MGPgSKu28iB1UhiKIupo4smPc%3D&reserved=0Background
Elbow replacement is used to relieve pain and restore function in the management of arthritis conditions, acute trauma and trauma sequelae. A recent review of the literature on elbow replacement has found no consistency in clinical outcome measures used to assess the effectiveness of interventions. The protocol describes a study to define a core outcome set for elbow replacement.Methods
The list of outcomes are taken from a scoping review that transferred outcomes verbatim from all 362 studies on elbow replacement published between 1990 to 2021. A survey advisory group including patients and carers will assess the Delphi questionnaire for readability and clarity and pilot the software before roll-out to study participants. A real-time Delphi survey will be conducted with key-stakeholders using online software over a period of four weeks. Participants will be able to view aggregated responses from other participants in real-time and to revisit their responses as many times as they wish during the study period. Participants will be able to propose additional items for inclusion which can be voted on by all participants. In a second survey participants will be asked to rate harms of elbow replacement based on the risk and impact on the patient, to provide reference values for future studies to enable calculation of the Comprehensive Classification Index of Harms.Conclusions
The study will address an important gap by defining a core outcome set for the clinical outcomes of elbow replacement obtained by consensus from patients, carers and healthcare professionals.REC name
London - Riverside Research Ethics Committee
REC reference
22/PR/1609
Date of REC Opinion
15 Dec 2022
REC opinion
Favourable Opinion