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Developing an outcome measures in rheumatology (OMERACT) core set of outcome measures for foot and ankle disorders in rheumatic and musculoskeletal diseases (COMFORT): Core domain set study protocol

Chapman, Lara S.; Redmond, Anthony C.; Flurey, Caroline A.; Richards, Pamela; Smith, Toby O.; Arnold, John B.; Beaton, Dorcas; Conaghan, Philip G.; Golightly, Yvonne M.; Hannan, Marian T.; Hofstetter, Catherine; Maxwell, Lara J.; Menz, Hylton B.; Shea, Beverley; Tugwell, Peter; Helliwell, Philip; Siddle, Heidi J.

Authors

Lara S. Chapman

Anthony C. Redmond

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Caroline Flurey Caroline2.Flurey@uwe.ac.uk
Associate Professor in Men's Health and Long-term Conditions

Pamela Richards

Toby O. Smith

John B. Arnold

Dorcas Beaton

Philip G. Conaghan

Yvonne M. Golightly

Marian T. Hannan

Catherine Hofstetter

Lara J. Maxwell

Hylton B. Menz

Beverley Shea

Peter Tugwell

Philip Helliwell

Heidi J. Siddle



Abstract

Background: Foot and ankle involvement is common in rheumatic and musculoskeletal diseases (RMDs). High-quality evidence is lacking to determine the effectiveness of treatments for these disorders. Heterogeneity in the outcomes used across clinical trials and observational studies hinders the ability to compare findings, and some outcomes are not always meaningful to patients and end-users. The Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT) study aims to develop a core outcome set (COS) for use in all trials of interventions for foot and ankle disorders in RMDs. This protocol addresses core outcome domains (what to measure) only. Future work will focus on core outcome measurement instruments (how to measure). Methods: COMFORT: Core Domain Set is a mixed-methods study involving the following: (i) identification of important outcome domains through literature reviews, qualitative interviews and focus groups with patients and (ii) prioritisation of domains through an online, modified Delphi consensus study and subsequent consensus meeting with representation from all stakeholder groups. Findings will be disseminated widely to enhance uptake. Conclusions: This protocol details the development process and methodology to identify and prioritise domains for a COS in the novel area of foot and ankle disorders in RMDs. Future use of this standardised set of outcome domains, developed with all key stakeholders, will help address issues with outcome variability. This will facilitate comparing and combining study findings, thus improving the evidence base for treatments of these conditions. Future work will identify suitable outcome measurement instruments for each of the core domains. Trial registration: This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, as of June 2022: https://www.comet-initiative.org/Studies/Details/2081.

Citation

Chapman, L. S., Redmond, A. C., Flurey, C. A., Richards, P., Smith, T. O., Arnold, J. B., …Siddle, H. J. (2023). Developing an outcome measures in rheumatology (OMERACT) core set of outcome measures for foot and ankle disorders in rheumatic and musculoskeletal diseases (COMFORT): Core domain set study protocol. Trials, 24(1), 65. https://doi.org/10.1186/s13063-023-07104-7

Journal Article Type Article
Acceptance Date Jan 18, 2023
Online Publication Date Jan 28, 2023
Publication Date 2023-01
Deposit Date Feb 17, 2023
Publicly Available Date Feb 17, 2023
Journal Trials
Print ISSN 1745-6215
Electronic ISSN 1745-6215
Publisher BioMed Central
Peer Reviewed Peer Reviewed
Volume 24
Issue 1
Pages 65
DOI https://doi.org/10.1186/s13063-023-07104-7
Keywords Study Protocol, Foot, Ankle, Rheumatology, Musculoskeletal, Core outcome set, Outcome measures, Consensus
Public URL https://uwe-repository.worktribe.com/output/10425486
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07104-7
Additional Information This article is licensed under a Creative Commons Attribution 4.0 International License.

The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

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Publisher Licence URL
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Copyright Statement
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.




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