Veldhuyzen van Zanten S J O, Chiba N, Armstrong D, Barkun A N, Thomson A B R, Mann V, Escobedo S, Chakraborty B, Nevin K
Division of Gastroenterology, Dalhousie University, Halifax, NS, Canada.
Aliment Pharmacol Ther. 2006 Feb 15;23(4):521-9. doi: 10.1111/j.1365-2036.2006.02774.x.
BACKGROUND: Currently there is no consensus on the optimal method to measure the severity of dyspepsia symptoms in clinical trials. AIM: To validate the 7-point Global Overall Symptom scale. METHODS: The Global Overall Symptom scale uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem. Validation was performed in two randomized-controlled trials (n = 1121 and 512). Construct validity: Global Overall Symptom was compared with the Quality of Life in Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and 10 specific symptoms using Spearman correlation coefficients. Test-retest reliability: The Intraclass Correlation Coefficient was calculated for patients with stable dyspepsia defined by no change in Overall Treatment Effect score over two visits. Responsiveness: effect size and standardized response mean were also calculated. RESULTS: Construct validity: Change in Global Overall Symptom score correlated significantly with Quality of Life for Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and specific symptoms (all P < 0.0002). Reliability: The Intraclass Correlation Coefficient was 0.62 (n = 205) and 0.42 (n = 270). Responsiveness: There was a positive correlation between change in Global Overall Symptom and change in symptom severity. The effect size and standardized response mean were 1.1 and 2.1, respectively. CONCLUSION: The Global Overall Symptom scale is a simple, valid outcome measure for dyspepsia treatment trials.
背景:目前在临床试验中,对于测量消化不良症状严重程度的最佳方法尚无共识。 目的:验证7分制总体症状量表。 方法:总体症状量表采用7分制李克特量表,范围从1 = 无问题到7 = 非常严重的问题。在两项随机对照试验(n = 1121和512)中进行验证。结构效度:使用斯皮尔曼相关系数将总体症状与反流和消化不良生活质量、胃肠道症状评定量表、反流病问卷以及10种特定症状进行比较。重测信度:对于两次就诊时总体治疗效果评分无变化所定义的消化不良症状稳定的患者,计算组内相关系数。反应度:还计算了效应大小和标准化反应均值。 结果:结构效度:总体症状评分的变化与反流和消化不良生活质量、胃肠道症状评定量表、反流病问卷以及特定症状显著相关(均P < 0.0002)。信度:组内相关系数分别为0.62(n = 205)和0.42(n = 270)。反应度:总体症状变化与症状严重程度变化之间存在正相关。效应大小和标准化反应均值分别为1.1和2.1。 结论:总体症状量表是消化不良治疗试验中一种简单、有效的结局测量方法。
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