Objectives
Foot and ankle involvement is common in rheumatic and musculoskeletal diseases, yet high-quality evidence assessing the effectiveness of treatments for these disorders is lacking. The Outcome Measures in Rheumatology (OMERACT) Foot and Ankle Working Group is developing a core outcome set for use in clinical trials and longitudinal observational studies in this area.
Methods
A scoping review was performed to identify outcome domains in the existing literature. Clinical trials and observational studies comparing pharmacological, conservative or surgical interventions involving adult participants with any foot or ankle disorder in the following rheumatic and musculoskeletal diseases (RMDs) were eligible for inclusion: rheumatoid arthritis (RA), osteoarthritis (OA), spondyloarthropathies, crystal arthropathies and connective tissue diseases. Outcome domains were categorised according to the OMERACT Filter 2.1.
Results
Outcome domains were extracted from 150 eligible studies. Most studies included participants with foot/ankle OA (63% of studies) or foot/ankle involvement in RA (29% of studies). Foot/ankle pain was the outcome domain most commonly measured (78% of studies), being the most frequently specified outcome domain across all RMDs. There was considerable heterogeneity in the other outcome domains measured, across core areas of manifestations (signs, symptoms, biomarkers), life impact, and societal/resource use. The group's progress to date, including findings from the scoping review, was presented and discussed during a virtual OMERACT Special Interest Group (SIG) in October 2022. During this meeting, feedback was sought amongst delegates regarding the scope of the core outcome set, and feedback was received on the next steps of the project, including focus group and Delphi methods.
Conclusion
Findings from the scoping review and feedback from the SIG will contribute to the development of a core outcome set for foot and ankle disorders in RMDs. The next steps are to determine which outcome domains are important to patients, followed by a Delphi exercise with key stakeholders to prioritise outcome domains.
Lara S. Chapman a b, Jennifer Jones a, Anthony C. Redmond a b c, Caroline A. Flurey d, Pamela Richards e, Catherine Hofstetter f, Toby O. Smith g, John B. Arnold h, Marian T. Hannan i, Lara J. Maxwell j, Hylton B. Menz k, Beverley Shea l, Yvonne M. Golightly m n, Peter Tugwell j, Dorcas Beaton o, Philip G. Conaghan a b c, Philip S. Helliwell a, Heidi J. Siddle
Disease Category: Rheumatology
Disease Name: Foot and ankle disorders
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Systematic review of outcomes measured in trials
- Systematic review
A search strategy was developed with input from the wider multi-disciplinary and multi-stakeholder OMERACT Foot and Ankle Working
Group, which includes four patient research partners. The following
databases were searched from 1980 to August 2020: Ovid MEDLINE,
Ovid Embase, Cumulative Index of Nursing and Allied Health (CINAHL),
Cochrane Library (Cochrane Central Register of Controlled Trials
(CENTRAL) and Cochrane Database of Systematic Reviews), Physiotherapy Evidence Database (PEDro). Additionally, three trial registries
(ClinicalTrials.gov, ISRCTN registry, ANZCTR) were searched from
2015-August 2020