纤维肌痛
评定量表
医学
疱疹后神经痛
慢性疼痛
物理疗法
安慰剂
普瑞巴林
骨关节炎
临床试验
腰痛
强度(物理)
物理医学与康复
神经病理性疼痛
心理学
内科学
麻醉
替代医学
病理
发展心理学
物理
量子力学
作者
John T. Farrar,James P. Young,L. LaMoreaux,John Werth,RM Poole
出处
期刊:Pain
[Ovid Technologies (Wolters Kluwer)]
日期:2001-11-01
卷期号:94 (2): 149-158
被引量:4494
标识
DOI:10.1016/s0304-3959(01)00349-9
摘要
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 PI-NRS 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.
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