Thomas Martin J, Rathod-Mistry Trishna, Harper Stephen, Parry Emma L, Pope Christopher, Neogi Tuhina, Peat George
Primary Care Centre Versus Arthritis, Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, United Kingdom.
Haywood Academic Rheumatology Centre, Haywood Hospital, Midlands Partnership NHS Foundation Trust, Staffordshire, United Kingdom.
JMIR Res Protoc. 2019 Apr 22;8(4):e13428. doi: 10.2196/13428.
The cardinal feature of osteoarthritis (OA) is pain. Although heterogeneity in pain and function have been demonstrated in the long-term course of OA, the more proximate determinants of acute flare-ups remain less clear. How short-term intermittent or transient exposures trigger acute flare-ups has important implications for effective and sustainable self-management strategies.
The primary objective of this study is to identify potential triggers of acute flares in knee OA. Secondary objectives are to determine their course and consequences and describe high-risk participant profiles.
We carried out a Web-based case-crossover study. This study aims to recruit 620 community-dwelling adults aged ≥40 years, resident in England, and who have knee pain, with or without a recorded diagnosis of knee OA, and no preexisting diagnosis of inflammatory arthropathy. Participants will be recruited via 3 routes: (1) general practice registers, (2) offline community advertisement, and (3) online social media advertisement. By using questionnaires comparing periods before participants' self-reported flare-up episodes (hazard periods) with periods during the study when their knee OA symptoms are stable (control periods), triggers preceding flare-ups will be identified and examined using conditional logistic regression. Time-to-resolution of flare-up will be examined by monitoring people's daily pain, bothersomeness, and medication usage until the participant reports when their flare-up episode ends. Rates of flare-ups will be examined across different participant and flare characteristics using regression models to identify high-risk participant profiles. A study-specific Patient Advisory Group (PAG) is providing suggestion, input, and ongoing support for all stages of the research process.
Participant recruitment opened in July 2018 and is anticipated to continue for 6 months. The study results will be disseminated through a number of channels, including relevant national or international conferences and peer-reviewed publication in a medical journal, via advocacy or charity organizations, such as Versus Arthritis and across social media. Findings will be fed back to members of our PAG, study participants, and clinicians from participating primary care general practices. The PAG will also take an active role in the overall dissemination strategy.
This study will provide empirical evidence to help patients identify common knee OA flare triggers and provide health care professionals with questions to identify patients at most risk of frequent flare-ups.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13428.
骨关节炎（OA）的主要特征是疼痛。尽管在OA的长期病程中已证明疼痛和功能存在异质性，但急性发作的更直接决定因素仍不太明确。短期间歇性或短暂暴露如何引发急性发作对有效且可持续的自我管理策略具有重要意义。
本研究的主要目的是确定膝骨关节炎急性发作的潜在触发因素。次要目的是确定其病程和后果，并描述高风险参与者特征。
我们开展了一项基于网络的病例交叉研究。本研究旨在招募620名年龄≥40岁、居住在英格兰、有膝关节疼痛、无论是否有膝骨关节炎记录诊断且无既往炎性关节病诊断的社区居民。参与者将通过3种途径招募：（1）全科医疗登记册，（2）线下社区广告，（3）在线社交媒体广告。通过使用问卷比较参与者自我报告的发作期（危险期）之前的时间段与研究期间其膝骨关节炎症状稳定的时间段（对照期），使用条件逻辑回归来识别和检查发作前的触发因素。通过监测人们的每日疼痛、困扰程度和药物使用情况，直至参与者报告其发作期结束，来研究发作的缓解时间。使用回归模型检查不同参与者和发作特征的发作率，以识别高风险参与者特征。一个专门针对本研究的患者咨询小组（PAG）正在为研究过程的各个阶段提供建议、投入和持续支持。
参与者招募于2018年7月开始，预计持续6个月。研究结果将通过多种渠道传播，包括相关的国家或国际会议以及在医学杂志上发表的同行评审文章，通过宣传或慈善组织，如对抗关节炎组织，并通过社交媒体传播。研究结果将反馈给我们的PAG成员、研究参与者以及参与初级保健全科医疗的临床医生。PAG也将在整体传播策略中发挥积极作用。
本研究将提供实证证据，以帮助患者识别常见的膝骨关节炎发作触发因素，并为医疗保健专业人员提供问题，以识别最易频繁发作的高风险患者。
国际注册报告识别码（IRRID）：DERR1-10.2196/13428
