Estimation of Minimum Clinically Important Difference for Pain in Fibromyalgia
Estimation of Minimum Clinically Important Difference for Pain in Fibromyalgia
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DOI：
10.1002/acr.20449
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发表时间：
2011-06-01
影响因子：
4.7
通讯作者：
Chappell, Amy S.
中科院分区：
文献类型：
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作者：
Mease, Philip J.;Spaeth, Michael;Chappell, Amy S.
目标。从纤维肌痛患者的简明疼痛问卷(BPI)中估计几种疼痛测量的最小临床重要差值(MCID)。数据汇集在4项随机、双盲、安慰剂对照研究的12周治疗期间，旨在评估度洛西汀治疗纤维肌痛的安全性和有效性。每项研究都纳入了美国风湿病学会定义为纤维肌痛的受试者，这些受试者表现为中度到重度疼痛。BPI平均疼痛项目评分和BPI严重程度评分(BPI疼痛评分值的平均值：当前、平均、最低和最差)的MCID通过锚定患者的总体改善印象评分来估计。BPI平均疼痛项目和严重程度评分的基于锚的MCID分别为2.1和2.2分。与基线相比，这些MCID分别减少了32.3%和34.2%。在这些分析中，从BPI获得的几个疼痛测量的MCID相似(类似于2个点)，对应于从基线到终点的30%-35%的改善。这些发现可能有益于设计临床试验，在临床试验中使用BPI来评估疼痛严重程度的改善。
Objective. To estimate the minimum clinically important difference (MCID) for several pain measures obtained from the Brief Pain Inventory (BPI) for patients with fibromyalgia.Methods. Data were pooled across 12-week treatment periods from 4 randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of duloxetine for the treatment of fibromyalgia. Each study enrolled subjects with American College of Rheumatology defined fibromyalgia who presented with moderate to severe pain. The MCIDs for the BPI average pain item score and the BPI severity score (the mean of the BPI pain scale values: right now, average, least, and worst) were estimated by anchoring against the Patient's Global Impressions of Improvement scale.Results. The anchor-based MCIDs for the BPI average pain item and severity scores were 2.1 and 2.2 points, respectively. These MCIDs correspond to 32.3% and 34.2% reductions from baseline in scores.Conclusion. In these analyses, the MCIDs for several pain measures obtained from the BPI were similar (similar to 2 points) and corresponded to a 30-35% improvement from baseline to end point. These findings may be beneficial for use in designing clinical trials in which the BPI is used to evaluate improvements in pain severity.