Quality of life in patients with endoscopy-negative heartburn: Reliability and sensitivity of disease-specific instruments
Quality of life in patients with endoscopy-negative heartburn: Reliability and sensitivity of disease-specific instruments
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DOI：
10.1016/s0002-9270(01)02495-9
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发表时间：
2001-07-01
影响因子：
9.8
通讯作者：
Wiklund, I
中科院分区：
文献类型：
--
作者：
Talley, NJ;Fullerton, S;Wiklund, I
结论：内镜阴性胃食管反流病（GERD）缺乏疾病严重程度的客观标志物。因此，GERD治疗的评价必须依赖于主观测量，包括患者自我报告问卷，以衡量治疗干预的临床有效性。我们的目的是评估先前验证的胃肠道症状评定量表（GSRS）和反流和消化不良生活质量（QOLRAD）问卷的可靠性和随时间变化的反应性。（n = 1143）与胃灼热，但没有食管炎纳入一项随机临床试验，评估积极治疗的有效性与质子泵抑制剂超过4周进行了评价。随着时间的推移，两份问卷的重测信度为良好至极好（GSRS 0.53-0.69; QOLRAD 0.65-0.76），通过标准化反应均值（GSRS反流维度，-1.43; QOLRAD 0.81-1.43）和效应量（GRSR反流维度，-1.74; QOLRAD 0.82-1.56）估计的反应性也是如此。GSRS反流维度评分的改善与患者自己估计的临床获益量之间的关系（基于总体治疗评价）表明，在应用的7个分级量表上，最小临床相关变化为0.5。GSRS反流维度和QOLRAD维度的重要性等级变化相当于1.0，非常重要变化相当于1.5。结论：GSRS和QOLRAD是可靠的、对变化敏感的有效问卷。这两种问卷都应适用于胃灼热患者治疗干预的临床试验。
OBJECTIVES: Endoscopy-negative gastroesophageal reflux disease (GERD) lacks objective markers of disease severity. Evaluation of therapies for GERD must therefore rely on subjective measures, including patient self-report questionnaires, to measure the clinical effectiveness of therapeutic interventions. We aimed to evaluate the previously validated Gastrointestinal Symptoms Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires for reliability and responsiveness to change over time.METHODS: Patients (n = 1143) with heartburn, but no esophagitis included in a randomized clinical trial assessing the effectiveness of active treatment with proton pump inhibitors over 4 wk were evaluated.RESULTS: The test-retest reliability of both questionnaires over time was good to excellent (GSRS 0.53-0.69; QOLRAD 0.65-0.76),as was the responsiveness estimated by standardized response means (GSRS reflux dimension, -1.43; QOLRAD 0.81-1.43) and effect sizes (GRSR reflux dimension, -1.74; QOLRAD 0.82-1.56). The relationship between improvement in the GSRS reflux dimension score and the amount; of clinical benefit as estimated by the patients themselves (based on the Overall Treatment Evaluation) suggested a minimally clinical relevant change is 0.5 on the seven graded scales applied. The importance rating indicated that an important change in the GSRS reflux dimension and the QOLRAD dimensions is equivalent to 1.0, and a very important change to 1.5.CONCLUSIONS: The GSRS and QOLRAD are valid questionnaires that are reliable and sensitive to change. Both questionnaires should be suitable for use in clinical trials of therapeutic interventions for patients with heartburn.