Rabeneck Linda, Wristers Kimberly, Goldstein Jay L, Eisen Glenn, Dedhiya Seema D, Burke Thomas A
Department of Veterans Affairs Health Services Research and Development Center of Excellence and Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
Am J Gastroenterol. 2002 Jan;97(1):32-9. doi: 10.1111/j.1572-0241.2002.05419.x.
We aimed to assess the Severity of Dyspepsia Assessment (SODA) scales as measures of change in dyspepsia-related health in a blinded, randomized, controlled trial in arthritis patients treated with nonsteroidal anti-inflammatory drugs.
Three thousand nine hundred seven arthritis patients completed SODA at baseline and weeks 4, 13, 26, and 52 and/or at early termination. Using baseline and 4-wk data, reliability was evaluated with Cronbach's a and the intraclass correlation coefficient (ICC). Dyspepsia adverse events were defined based on a combined set of World Health Organization Adverse Reaction Terminology terms. The ability of SODA to measure change in dyspepsia-related health was evaluated by comparing SODA change scores by dyspepsia adverse event severity level and withdrawal status. Responsiveness was further evaluated by the area under the curve (AUC) from receiver operating characteristic curves using withdrawal due to dyspepsia as the criterion.
The SODA scales--Pain Intensity (alpha = 0.93), Non Pain Symptoms (alpha = 0.82), and Satisfaction (alpha = 0.89)--demonstrated excellent internal consistency reliability using baseline data. Reproducibility was fair to good: Pain Intensity ICC = 0.49, Non Pain Symptoms ICC = 0.61, and Satisfaction ICC = 0.45. SODA change scores (4-wk score - baseline score) increased, or worsened, with increasing dyspepsia severity and differentiated between adjacent levels of dyspepsia severity for eight of nine adjacent comparisons (p < 0.05). SODA change scores also differentiated between those who did and did not withdraw (p < 0.001). Responsiveness was highest with the Pain Intensity scale (AUC = 0.78), followed by the Non Pain Symptoms (AUC = 0.74) and Satisfaction (AUC = 0.75) scales.
SODA is a reliable, valid instrument for use as a measure of dyspepsia tolerability in future clinical trials involving cyclo-oxygenase-2-specific and/or traditional nonsteroidal anti-inflammatory drugs.
在一项针对使用非甾体抗炎药治疗的关节炎患者的双盲、随机、对照试验中，我们旨在评估消化不良严重程度评估（SODA）量表作为消化不良相关健康状况变化的衡量指标。
3907名关节炎患者在基线、第4周、第13周、第26周和第52周及/或提前终止治疗时完成了SODA量表评估。利用基线和第4周的数据，采用克朗巴哈系数（Cronbach's a）和组内相关系数（ICC）评估信度。消化不良不良事件根据一组综合的世界卫生组织不良反应术语进行定义。通过比较不同消化不良不良事件严重程度水平和停药状态下的SODA变化分数，评估SODA量表衡量消化不良相关健康状况变化的能力。使用以消化不良导致停药为标准的受试者工作特征曲线下面积（AUC）进一步评估反应度。
SODA量表——疼痛强度（α = 0.93）、非疼痛症状（α = 0.82）和满意度（α = 0.89）——使用基线数据显示出极佳的内部一致性信度。再现性从中等到良好：疼痛强度ICC = 0.49，非疼痛症状ICC = 0.61，满意度ICC = 0.45。随着消化不良严重程度的增加，SODA变化分数（第4周分数 - 基线分数）升高或恶化，并且在九组相邻比较中的八组中，能够区分相邻的消化不良严重程度水平（p < 0.05）。SODA变化分数在停药者和未停药者之间也有差异（p < 0.001）。疼痛强度量表的反应度最高（AUC = 0.78），其次是非疼痛症状量表（AUC = 0.74）和满意度量表（AUC = 0.75）。
在未来涉及环氧化酶-2特异性和/或传统非甾体抗炎药的临床试验中，SODA是一种可靠、有效的工具，可用于衡量消化不良的耐受性。
