Foot and ankle disorders are common in rheumatic and musculoskeletal diseases (RMDs). In rheumatoid arthritis, foot and ankle pain is consistently reported to occur in 80-94% of people with the condition, whilst foot and ankle osteoarthritis affects almost 17% of people aged over 50. Foot involvement is also prevalent in gout, systemic lupus erythematous and systemic sclerosis. These disorders are associated with significant pain and disability, impacting on tasks essential to daily living, and lead to loss of independence and reduced quality of life.
Despite widespread use of conservative, pharmacological and surgical treatments for foot and ankle disorders in RMDs in clinical practice, there remains a lack of high-quality evidence assessing their effectiveness and existing research outputs are not typically translated into practice. A significant factor contributing to these issues is the heterogeneity of outcome measures used across studies to assess the effectiveness of treatments, hindering the ability to compare and contrast findings between studies and to pool data in meta-analyses.
This project aims to develop a core outcome set (COS) for foot and ankle disorders in RMDs. It will be undertaken with the international Outcome Measures in Rheumatology initiative (OMERACT).
Principal Investigator: Lara Chapman, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor Chapel Allerton Hospital, Chapeltown Road, Leeds, LS7 4SA, UK. Email: L.Chapman1@leeds.ac.uk
Dr Heidi Siddle, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor Chapel Allerton Hospital, Chapeltown Road, Leeds, LS7 4SA, UK. Email: H.Siddle@leeds.ac.uk
Professor Anthony Redmond: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, 2nd Floor Chapel Allerton Hospital, Chapeltown Road, Leeds, LS7 4SA, UK. Email: A.Redmond@leeds.ac.uk
Dr Caroline Flurey, Faculty of Health and Applied Sciences – Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY. Email: Caroline2.Flurey@uwe.ac.uk
Ms Pamela Richards, OMERACT Patient Research Partner.
OMERACT Foot & Ankle Working Group (Working Group Senior Methodologist: Dr Beverley Shea, University of Ottawa; Executives: Professor Philip Conaghan, University of Leeds; Professor Peter Tugwell, University of Ottawa; Co-Chairs: Dr Heidi Siddle; Professor Philip Helliwell, University of Leeds; Professor Hylton Menz, La Trobe University; Professor Marian Hannan, Harvard Medical School).
Professor Catherine Bowen, School of Health Sciences, University of Southampton.
Professor Melanie Calvert, Institute of Applied Health Research, University of Birmingham.
Dr Toby Smith, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford.
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Literature review
- Systematic review
Phase 1: Identification of outcome domains of importance
A scoping review will identify outcome domains and outcome measurement instruments reported in existing trials of foot and ankle disorders in RMDs. A thematic synthesis of qualitative studies, followed by individual semi-structured interviews with patients, will identify any additional outcomes of importance. Outcomes identified in the existing literature and through the interviews will be grouped, amalgamated and defined by the OMERACT Foot & Ankle Working Group to create a “long list” of outcomes.
Phase 2: Consensus on a core set of outcome domains
An online, modified Delphi study will be conducted. Key stakeholders (patients, health professionals, researchers, industry representatives, and guideline developers) will prioritise the “long list” of outcomes over three rounds. An international consensus meeting will take place, where agreement on a final core domain set will be achieved.
Phase 3: Identification of outcome measurement instruments
A systematic review of the measurement properties of candidate outcome measurement instruments, using COSMIN criteria, will be carried out. Candidate outcome measurement instruments will be conceptually aligned to core domains.