Holtmann G, Chassany O, Devault K R, Schmitt H, Gebauer U, Doerfler H, Malagelada J R
Department of Medicine, University of Adelaide, Adelaide, SA, Australia.
Aliment Pharmacol Ther. 2009 Mar 15;29(6):615-25. doi: 10.1111/j.1365-2036.2008.03922.x. Epub 2008 Dec 19.
Although erosive gastro-oesophageal reflux disease (GERD) is a highly prevalent condition, there is no specific, valid, reliable and sensitive questionnaire that allows evaluating treatment-induced changes in health-related quality of life (HRQoL).
To design a self-administered questionnaire, the GERD Analyzer (GERDyzer), for use in clinical studies.
The GERDyzer comprises 10 dimensions each illustrated by pictogram-like drawings, simplifying communication with the patients. Self-assessment is performed by 100 mm Visual Analogue Scales. For validation, a 5-week clinical trial involving 395 patients (per-protocol) with oesophagitis was conducted. Patients were treated with pantoprazole (40 mg o.d.) for 28 days. Psychometric analyses included internal consistency, test-retest reliability, responsiveness and construct validity.
Factor analysis showed consistency of the dimensions and no reduction was necessary. Validation of GERDyzer indicated high internal consistency (Cronbach's alpha = 0.95) and test-retest reliability (intraclass correlation coefficient =0.91). Responsiveness of the total score expressed by nonparametric effect size was 1.38. Comparison of scores with other questionnaires resulted in logical correlation levels depending on the respected concepts measured. Conclusions GERDyzer proved to be highly valid, reproducible and responsive. It allows reliably assessing treatment-induced changes in HRQoL in erosive GERD.
尽管糜烂性胃食管反流病（GERD）极为常见，但尚无一种特定、有效、可靠且敏感的问卷可用于评估治疗引起的健康相关生活质量（HRQoL）变化。
设计一种用于临床研究的自填式问卷——GERD分析仪（GERDyzer）。
GERDyzer包含10个维度，每个维度都由类似象形图的图示说明，简化了与患者的沟通。通过100毫米视觉模拟量表进行自我评估。为进行验证，开展了一项为期5周的临床试验，纳入395例（符合方案集）食管炎患者。患者接受泮托拉唑（40毫克，每日一次）治疗28天。心理测量分析包括内部一致性、重测信度、反应度和结构效度。
因子分析显示各维度具有一致性，无需缩减。GERDyzer的验证表明其具有高内部一致性（克朗巴哈系数=0.95）和重测信度（组内相关系数=0.91）。非参数效应量表示的总分反应度为1.38。与其他问卷得分的比较得出取决于所测量相关概念的逻辑相关水平。结论GERDyzer被证明具有高度有效性、可重复性和反应度。它能够可靠地评估糜烂性GERD治疗引起的HRQoL变化。
