The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials
The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials
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DOI：
10.1186/1477-7525-6-31
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发表时间：
2008-04-30
影响因子：
3.6
通讯作者：
Johnsson, Folke
中科院分区：
文献类型：
--
作者：
Shaw, Michael;Dent, John;Johnsson, Folke
背景：胃食道反流病(GERD)治疗试验的关键需求包括评估治疗反应、评估症状严重程度和将症状问卷翻译成多种语言。我们评估了先前验证的反流病问卷(RDQ)的内部一致性、可靠性和对治疗过程中变化的反应性，以及RDQ与专科医生对症状严重程度的评估的一致性。方法：在一项随机、双盲的质子泵抑制剂积极治疗试验中，对439名推定为GERD的患者翻译成瑞典语和挪威语后的RDQ进行了评估。在积极治疗的患者中，平均变化分数很大，也反映在效果大小上，范围从1.05(消化不良)到2.05(烧心)，标准化反应平均值为0.99(消化不良)和1.52(烧心)。医生严重度评分和RDQ量表得分之间有很好的正相关。量表的阿尔法系数的内部一致性信度在0.67~0.89之间，与语言无关。结论：RDQ具有较强的可译性，是评估治疗反应和症状严重程度的一种可行工具。
Background: Critical needs for treatment trials in gastroesophageal reflux disease (GERD) include assessing response to treatment, evaluating symptom severity, and translation of symptom questionnaires into multiple languages. We evaluated the previously validated Reflux Disease Questionnaire (RDQ) for internal consistency, reliability, responsiveness to change during treatment and the concordance between RDQ and specialty physician assessment of symptom severity, after translation into Swedish and Norwegian.Methods: Performance of the RDQ after translation into Swedish and Norwegian was evaluated in 439 patients with presumed GERD in a randomized, double-blind trial of active treatment with a proton pump inhibitor.Results: The responsiveness was excellent across three RDQ indicators. Mean change scores in patients on active treatment were large, also reflected in effect sizes that ranged from a low of 1.05 (dyspepsia) to a high of 2.05 (heartburn) and standardized response means 0.99 (dyspepsia) and 1.52 (heartburn). A good positive correlation between physician severity ratings and RDQ scale scores was seen. The internal consistency reliability using alpha coefficients of the scales, regardless of language, ranged from 0.67 to 0.89.Conclusion: The results provide strong evidence that the RDQ is amenable to translation and represents a viable instrument for assessing response to treatment, and symptom severity.