Pain measurement: Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) in clinical trials with OTC analgesics in headache
Pain measurement: Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) in clinical trials with OTC analgesics in headache
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DOI：
10.1177/0333102411430856
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发表时间：
2012-02-01
期刊：
影响因子：
4.9
通讯作者：
Diener, H-C
中科院分区：
文献类型：
--
作者：
Aicher, B.;Peil, H.;Diener, H-C
目的：其目的是评估的视觉Anglomeration量表（VAS）的性能在招募的患者在临床试验中与非处方镇痛剂在headach.Methods：的研究表明，乙酰水杨酸+扑热息痛+咖啡因的固定组合的显着优势，在没有咖啡因的组合，单一制剂，安慰剂在头痛的治疗。入组研究的患者通过命名6分口头评定量表（VRS）的类别接受VAS处理培训。这些数据被用来评估的水平之间的VAS和VRS的顺序一致性，推导出截断点重新调整连续VAS到一个离散的顺序规模使用接收器操作特性的方法，并评估的测试-重测performance.Results：大约75%的患者记录的疼痛强度的VAS在相同的顺序上的VRS。然而，在12.6%的患者中，德语术语“leicht”（轻度）和“leicht”（中度）在VAS上的顺序混淆。对于VRS类别轻度和中度疼痛以及重度和非常重度疼痛，发现VAS评估的频率分布基本重叠。将VAS评估转换为离散顺序量表需要根据VRS类别进行非等距重新标度。通过分析受试者工作特征曲线，在100 mm VAS上确定以下截止点：无痛0-2 mm，轻度疼痛2-17 mm，中度疼痛17-47 mm，重度疼痛47-77 mm，极重度疼痛77-96 mm，可想象的最严重疼痛96-100 mm。首次评估后长达数月的重复评估表明，VAS的重测一致率为61.0-91.4%结论：本研究表明，VRS类别不能在VAS上以等距方式呈现，并且与先前的假设相反，疼痛强度描述符不太清楚，并且在不同的语言中可能具有不同的含义。因此，在第3版国际头痛分类（ICHD-III）和头痛疾病患者临床试验指南中，应推荐6级或更高级别的VRS或VAS，而不是4级VRS，并相应地广泛定义锚点。
Aim: The aim was to assess the performance of the Visual Analogue Scale (VAS) in patients recruited in a clinical trial with over the counter analgesics in headache.Methods: The Thomapyrin Study showed the significant superiority of the fixed combination of acetylsalicylic acid + paracetamol + caffeine over the combination without caffeine, the single preparations, and placebo in the treatment of headache. Patients enrolled into the study were trained in the handling of the VAS by naming categories of a 6-point Verbal Rating Scale (VRS). These data were used to evaluate the level of order consistency between the VAS and VRS, to deduce cut-off points for rescaling the continuous VAS into a discrete ordinal scale using the receiver operating characteristic methodology, and to assess the test-retest performance.Results: Approximately 75% of the patients recorded the pain intensity on the VAS in the same order as given on the VRS. However, in 12.6% of patients, the German terms 'leicht' (mild) and 'massig' (moderate) were mixed up regarding their order on the VAS. Substantial overlapping of the frequency distributions of the VAS assessment were found for the VRS categories mild and moderate pain as well as severe and very severe pain. Grouping of the VAS assessments into a discrete ordinal scale necessitated a non-equidistant rescaling based on the categories of the VRS. By means of analysis of the receiver operating characteristic curves, the following cut-off points were determined on a 100 mm VAS: no pain 0-2 mm, mild pain 2-17 mm, moderate pain 17-47 mm, severe pain 47-77 mm, very severe pain 77-96 mm, most severe pain imaginable 96-100 mm. Repeated assessment up to several months after the first assessment demonstrated a test-retest agreement on the VAS in 61.0-91.4% of the patients, depending on the VRS category.Conclusions: This study shows that the VRS categories cannot be presented in an equidistant manner on the VAS, and that contrary to previous assumptions, the pain intensity descriptors are less clear and can have different meanings in different languages. Therefore, both in the 3rd edition of the International Headache Classification (ICHD-III) and in the guidelines for clinical trials of patients with headache illnesses, rather than a 4-grade VRS, a 6-grade or higher level VRS or a VAS should be recommended, with correspondingly broadly defined anchor points.