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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
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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 and Siddle, Heidi 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. doi:10.1186/s13063-023-07104-7 ISSN 1745-6215.
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Official URL: http://dx.doi.org/10.1186/s13063-023-07104-7
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
Item Type: | Journal Article | |||||||||
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Subjects: | R Medicine > RC Internal medicine R Medicine > RD Surgery |
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Rheumatism, Rheumatology -- Outcome assessment, Musculoskeletal system -- Diseases -- Patients -- Evaluation, Foot -- Diseases, Ankle -- Diseases, Musculoskeletal system -- Diseases -- Diagnosis, Outcome assessment (Medical care) | |||||||||
Journal or Publication Title: | Trials | |||||||||
Publisher: | Biomed Central | |||||||||
ISSN: | 1745-6215 | |||||||||
Official Date: | 28 January 2023 | |||||||||
Dates: |
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Volume: | 24 | |||||||||
Number: | 1 | |||||||||
Number of Pages: | 10 | |||||||||
Article Number: | 65 | |||||||||
DOI: | 10.1186/s13063-023-07104-7 | |||||||||
Status: | Peer Reviewed | |||||||||
Publication Status: | Published | |||||||||
Access rights to Published version: | Open Access (Creative Commons) | |||||||||
Date of first compliant deposit: | 7 March 2023 | |||||||||
Date of first compliant Open Access: | 8 March 2023 | |||||||||
RIOXX Funder/Project Grant: |
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