Title: Development of a Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT)
Funder: Health Education England

Abstract: BackgroundFoot and ankle disorders are common in rheumatic and musculoskeletal diseases (RMDs) and are associated with significant pain and disability. There is currently a lack of high-quality evidence relating to the efficacy of interventions for these disorders and existing research outputs are not typically translated into practice. To influence policy and practice, the selection of study outcome domains needs to be important and relevant to all key stakeholders. Development of a standardised set of core outcomes to be measured and reported as a minimum in all studies of foot and ankle disorders in RMDs, through consensus processes with all key stakeholders, presents a solution to these issues.Aim The COMFORT project aims to establish a standardised core set of outcome measures for foot and ankle disorders in RMDs.Objectives To identify, explore and prioritise outcomes of importance to patients with foot and ankle disorders in RMDs, and to clinicians who treat these patients. To achieve multidisciplinary, multi-stakeholder and expert international consensus and endorsement of a core set of outcome domains for foot and ankle disorders in RMDs, and determine which outcome measurement instruments can measure each domain. To establish the feasibility and acceptability of measuring the core outcome set in clinical rheumatology research.MethodsThis project will involve a rigorous, iterative, mixed-methods approach consisting of three work packages over 45 months (0.8WTE):WP1: Exploration of conceptual domains of importance (objective 1), involving two phases: Individual semi-structured interviews with patients. International focus groups with patients and clinicians, utilising nominal group technique.Timeline for delivery: April 2022-September 2023.WP2: Definition of a core outcome set (objective 2), involving two phases: Modified Delphi study and consensus meeting involving all relevant stakeholders to establish a core set of outcome domains. Update of an existing systematic review of the validity, reliability and responsiveness of candidate outcome measure instruments, and conceptual alignment of these instruments with the core domains.Timeline for delivery: August 2023-July 2024.WP3: Feasibility and acceptability testing of the core outcome set in clinical rheumatology research (objective 3), involving one phase: Fidelity testing, think-aloud methods, and semi-structured interviews with patients and clinical researchers. Timeline for delivery: June 2024-September 2025.Anticipated impact Improved understanding of patients' and clinicians' outcome priorities, informing clinical rheumatology practice. Increased research value of future studies by reducing the risk of inconsistent, incomplete and biased outcome reporting, and increasing the feasibility of conducting meta-analyses. Increased transferability of research findings to practice by measuring outcomes reflecting endpoints that are meaningful and relevant for all stakeholders. Improved understanding of the feasibility of implementing the COS in clinical research.DisseminationDissemination and implementation strategies will be finalised with PPI contributors and international experts within OMERACT. Dissemination will include conference presentations, publications, plain English summaries and social media posts. Uptake of the core outcome set will involve engagement with relevant organisations, funding bodies and guideline developers. This will be achieved through collaborations I have established in developing this application, which will continue throughout my CDRF.

Lay abstract: Why is this research needed? Foot and ankle problems are common in rheumatic and musculoskeletal diseases (RMDs), such as different types of arthritis and gout. Foot and ankle problems cause pain and disability, limiting work and socialising. To help patients and health professionals make decisions about treatments for these problems, we need evidence about which treatments work best. Researchers find this out by measuring the effects of treatments on 'outcomes'. Examples of 'outcomes' include pain or how hard it is to walk. Outcomes are measured using 'outcome measurement tools' such as pain scales and questionnaires that either the patient or the health professional completes. As a podiatrist who looks after people with foot and ankle problems, I know that there is a lack of good quality evidence for many foot and ankle treatments, so it is difficult to make decisions in clinic. A major issue leading to this is a lack of agreement on what to measure in foot and ankle research studies (the outcomes) and how we work out if these measurements are effective. This makes it hard to compare and combine results from studies to decide which treatments work best. Patients and health professionals often have different opinions about which health outcomes are important, but researchers do not always consider this. What is the purpose of this research? This research aims to establish an agreed, standardised set of important (core) outcomes. I will work with an international outcomes organisation (OMERACT), who have developed core outcome sets for many diseases and body systems. The resulting set of outcomes should be measured and reported, as a minimum, in all research studies for foot and ankle disorders in RMDs. This will lead to more trustworthy and relevant results, and better quality evidence for treatments. How will I carry out this research? Firstly, I will interview individual patients with foot and ankle problems to find out which outcomes they think are important and why. I will then hold small discussion groups with patients and health professionals, asking them to talk about their experiences of foot and ankle problems, and the treatments for these problems. In these groups, patients and health professionals will be asked to sort cards to rate which outcomes are most important to them. The next step will be to achieve agreement on the most important outcomes to measure. I will ask a much bigger group of stakeholders, including patients, health professionals and researchers, to prioritise the outcomes using anonymous online surveys. A meeting will take place and stakeholders will have a final vote on the core outcome set. I will then decide how each core outcome should be measured in research. I will do this by looking at the current evidence for existing 'outcome measurement tools' and by matching these to the outcomes. Finally, I will explore how well the core outcome set works in research. I will ask patients and health professionals to complete the set of outcome measures. I will record how long this takes and identify any issues that arise. I will interview some of the participants after they have taken part, to explore their opinions in greater depth. People with foot and ankle problems in RMDs have been actively involved in developing this research. They expressed concerns that foot and ankle complaints are often trivialised despite being debilitating. They provided insight into how patients can be fully included during each part of this study. They will continue to provide input throughout this research. Research findings will be shared with: RMD charities Social media channels Patient and public involvement groups Health professionals and researchers at conferences

Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: MUSCULOSKELETAL;INFLAMMATORY AND IMMUNE SYSTEM