Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis, Nottingham, UK.
Trials. 2023 Jan 28;24(1):65. doi: 10.1186/s13063-023-07104-7.
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).
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.
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.
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.
足部和踝关节疾病在风湿和肌肉骨骼疾病（RMDs）中很常见。缺乏高质量的证据来确定这些疾病的治疗效果。临床试验和观察性研究中使用的结果存在异质性，这阻碍了比较研究结果的能力，而且有些结果对患者和最终用户并不总是有意义。足部和踝关节疾病在风湿和肌肉骨骼疾病中的核心结局测量（COMFORT）研究旨在开发一套核心结局集（COS），用于所有 RMD 足部和踝关节疾病干预措施的试验。本方案仅涉及核心结局领域（要测量什么）。未来的工作将集中于核心结局测量工具（如何测量）。
COMFORT：核心领域集是一项混合方法研究，包括以下内容：（i）通过文献综述、患者定性访谈和焦点小组，确定重要的结局领域；（ii）通过在线、改良 Delphi 共识研究和随后的共识会议，对领域进行优先排序，这些会议将代表所有利益相关者群体参加。研究结果将广泛传播，以提高其利用率。
本方案详细介绍了在风湿和肌肉骨骼疾病的足部和踝关节疾病这一新兴领域中确定和优先考虑 COS 领域的开发过程和方法。未来使用这个由所有主要利益相关者共同制定的标准化结局领域集，将有助于解决结局变异性问题。这将有助于比较和合并研究结果，从而改善这些疾病治疗的证据基础。未来的工作将确定每个核心领域的合适的结局测量工具。
该研究于 2022 年 6 月在有效性试验的核心结局测量物（COMET）数据库中注册：https://www.comet-initiative.org/Studies/Details/2081。
