Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale
Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale
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DOI：
10.1016/s0304-3959(01)00349-9
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发表时间：
2001-11-01
期刊：
影响因子：
7.4
通讯作者：
Poole, RM
中科院分区：
文献类型：
--
作者：
Farrar, JT;Young, JP;Poole, RM
疼痛强度通常采用11点疼痛强度数值评定量表（PI-NRS）测量，其中0 =无疼痛，10 =最严重可能疼痛。然而，很难解释该量表较基线变化的临床重要性（例如1分或2分变化）。到目前为止，对于慢性疼痛研究中使用的疼痛强度量表的临床重要差异，尚无数据驱动的估计值。我们通过将其与多项慢性疼痛研究的变化的全球评估相关联，估计了该量表上的临床重要差异。数据来自10个最近完成的安慰剂对照临床试验，普瑞巴林在糖尿病神经病变，带状疱疹后神经痛，慢性腰痛，纤维肌痛，骨关节炎的2724例受试者。这些研究具有相似的设计和测量工具，包括在每日日记中收集的PI-NRS，以及在终点收集的标准七点患者总体变化印象（PGIC）。将PI-NRS从基线至终点的变化与每例受试者的PGIC进行比较。使用“大幅改善”和“非常显著改善”类别作为临床重要差异的决定因素，并使用图表、箱形图和灵敏度/特异性分析探索与PI-NIRS的关系。无论研究、疾病类型、年龄、性别、研究结果或治疗组如何，均证明了PI-NRS变化与PGIC之间的一致关系。平均而言，PI-NRS降低约2分或降低约30%代表具有临床意义的差异。无论基线疼痛如何，百分比变化与PGIC之间的关系也是一致的，而较高的基线评分需要较大的原始变化才能代表具有临床意义的差异。这些结果在未来研究中的应用可能会为慢性疼痛治疗临床试验中的临床重要改善提供标准定义。在慢性疼痛研究中使用标准结局将大大提高这些研究的可比性、有效性和临床适用性。(C)2001年国际疼痛研究协会。由Elsevier Science B. V.出版，版权所有。
Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0 = no pain and 10 = worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of 'much improved' and 'very much improved' were used as determinants of a clinically important difference and the relationship to the Pl-NIRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies. (C) 2001 International Association for the Study of Pain. Published by Elsevier Science B.V. All rights reserved.