Identifying flares in rheumatoid arthritis: reliability and construct validation of the OMERACT RA Flare Core Domain Set
Identifying flares in rheumatoid arthritis: reliability and construct validation of the OMERACT RA Flare Core Domain Set
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DOI：
10.1136/rmdopen-2015-000225
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发表时间：
2016-01-01
期刊：
影响因子：
6.2
通讯作者：
Bartlett, Susan J.
中科院分区：
文献类型：
--
作者：
Bykerk, Vivian P.;Bingham, Clifton O.;Bartlett, Susan J.
目的：采用3种方法（患者、风湿病医生和疾病活动评分（DAS）28个标准）评估并发耀斑识别的可靠性，构建代表风湿病临床试验结果测量（OMERACT） RA耀斑核心域集的候选项目的效度。方法：在2011年11月至2014年11月期间，对加拿大早期关节炎队列（CATCH）患者进行连续就诊的候选耀斑问题和遗留测量。记录美国风湿病学会（ACR）核心组指标。使用一致系数评估识别耀斑的一致性。对闪焰问题的结构效度进行检验：收敛（Spearman’s r）；判别性（显著/非显著患者之间的平均差异）；和相应的（与先前治疗减少和预期治疗后改变的比例）。结果：849例患者中75%为女性，81%为白人，42%缓解/低疾病活动度（R/LDA）， 16-32%在第二次就诊时发作。耀斑状态的一致性较低（x值为0.17-0.88），与RA疾病活动水平呈负相关。耀斑域与患者整体（r’s >= 0.66）和相应措施（r’s 0.49 ~ 0.92）高度相关（r’s >= 0.70）；中度高度与MD和患者报告的关节计数相关（r为0.29-0.62）。当MD/患者同意患者有耀斑时，组间平均耀斑域差异为2.1-3.0；36%的患者在发作前减少了治疗，61%的患者计划增加治疗。结论：耀斑在类风湿关节炎（RA）中很常见，通常在治疗前减少。在R/LDA恶化的患者中，患者/MD/DAS对耀斑状态的一致性最高。OMERACT RA耀斑问题可以区分有或没有耀斑的患者，并有强有力的证据证明其结构和结果效度。正在进行的工作将确定最佳评分和切割点，以识别RA耀斑。
Objective: To evaluate the reliability of concurrent flare identification using 3 methods (patient, rheumatologist and Disease Activity Score (DAS)28 criteria), and construct validity of candidate items representing the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA Flare Core Domain Set.Methods: Candidate flare questions and legacy measures were administered at consecutive visits to Canadian Early Arthritis Cohort (CATCH) patients between November 2011 and November 2014. The American College of Rheumatology (ACR) core set indicators were recorded. Concordance to identify flares was assessed using the agreement coefficient. Construct validity of flare questions was examined: convergent (Spearman's r); discriminant (mean differences between flaring/non-flaring patients); and consequential (proportions with prior treatment reductions and intended therapeutic change postflare).Results: The 849 patients were 75% female, 81% white, 42% were in remission/low disease activity (R/LDA), and 16-32% were flaring at the second visit. Agreement of flare status was low strong (x's 0.17-0.88) and inversely related to RA disease activity level. Flare domains correlated highly (r's >= 0.70) with each other, patient global (r's >= 0.66) and corresponding measures (r's 0.49-0.92); and moderately highly with MD and patient-reported joint counts (r's 0.29-0.62). When MD/patients agreed the patient was flaring, mean flare domain between-group differences were 2.1-3.0; 36% had treatment reductions prior to flare, with escalation planned in 61%.Conclusions: Flares are common in rheumatoid arthritis (RA) and are often preceded by treatment reductions. Patient/MD/DAS agreement of flare status is highest in patients worsening from R/LDA. OMERACT RA flare questions can discriminate between patients with/without flare and have strong evidence of construct and consequential validity. Ongoing work will identify optimal scoring and cut points to identify RA flares.