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首页> 外文期刊>The journal of pain: official journal of the American Pain Society >The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders.
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The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders.

机译：从0到10的数字等级量表变化对最坏，最小和平均疼痛强度的临床重要性：来自度洛西汀治疗疼痛疾病的临床试验数据分析。

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摘要

Data on 1,700 patients pooled from 5 randomized, placebo-controlled duloxetine studies (3 in diabetic peripheral neuropathic pain and 2 in fibromyalgia) were analyzed to determine clinically important differences (CIDs) in the 0 to 10 Numeric Rating Scale-Pain Intensity (NRS-PI) for patient-reported "worst" and least average percentage change in the NRS-PI for the worst, least, and average pain were compared to patients' perceived improvements at endpoint as measured by the 7-point Patient Global Impression of Improvement (PGI-I) scales. Stratification by baseline pain separated the raw but not the percent change scores. The PGI-I category of "much better" or above was our a priori definition of a CID. Cutoff points for the NRS-PI change scores were determined using a receiver operator curve analysis. A consistent relationship between the worst and average NRS-PI percent change and the PGI-I was demonstrated regardless of the study, pain type, age, sex, or treatment group with a reduction of approximately 34%. The least pain item CID was slightly higher at 41%. Raw change CID cutoff points were approximately -2, -2.5 and -3 for least, average, and worst pain respectively. PERSPECTIVE: We determined an anchor-based value for the change in the worst, least, and average pain intensity items of the Brief Pain Inventory that best represents a clinically important difference. Our findings support a standard definition of a clinically important difference in clinical trials of chronic-pain therapies.
机译：分析了5项随机，安慰剂对照的度洛西汀研究（3例在糖尿病周围神经性疼痛中2例在纤维肌痛中）收集的1,700例患者的数据，以确定0到10的数字评分量表疼痛强度（NRS-将患者报告的“最差”和最差，最小和平均疼痛的NRS-PI平均变化百分比与患者感知的终点改善进行比较，以7点患者总体改善印象（ PGI-I）标度。通过基线疼痛进行分层可以将原始得分（而不是百分比变化）分开。 “更好”或更高的PGI-I类别是我们对CID的先验定义。使用接收机操作员曲线分析确定NRS-PI变化评分的临界点。无论研究，疼痛类型，年龄，性别或治疗组如何，NRS-PI最差和平均百分比变化与PGI-I之间的一致性都得到了证实，减少了约34％。最小疼痛项目的CID略高，为41％。最小，平均和最差疼痛的原始变化CID临界点分别约为-2，-2.5和-3。观点：我们确定了简短疼痛量表中最能代表临床上重要差异的最痛，最轻和平均疼痛强度项目的变化基于锚的值。我们的发现支持慢性疼痛疗法临床试验中临床上重要差异的标准定义。

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