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.
i) Establish the frequency and scope of outcome domains previously reported in clinical trials
of interventions for foot and ankle disorders in RMDs;
(ii) Identify additional outcome domains of importance to patients with RMDs who have experienced
foot and ankle disorders;
(iii) Achieve multidisciplinary, multi-stakeholder and expert international consensus and endorsement of a core set of outcome domains for foot and ankle disorders in RMDs.
Lara S. Chapman, Anthony C. Redmond, Caroline A. Flurey, 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 and Heidi J. Siddle
Disease Category: Rheumatology
Disease Name: Foot and ankle disorders
Age Range: Unknown
Sex: Either
Nature of Intervention: Drug, Surgery
- COS for clinical trials or clinical research
- COS for practice