Stanghellini V, Armstrong D, Mönnikes H, Bardhan K D
S. Orsola-Malpighi Hospital, Bologna, Italy.
Digestion. 2007;75 Suppl 1:3-16. doi: 10.1159/000101077. Epub 2007 May 4.
Gastro-oesophageal reflux disease (GERD) is highly prevalent in Western countries. Because the majority of patients do not present with endoscopic abnormalities, the assessment of the symptom severity and quality of life, and their response to treatment, has become increasingly important. Self-assessed symptom questionnaires are now key instruments in clinical trials.
To evaluate the validity of available GERD measurement tools.
An ideal GERD symptom assessment instrument, suitable as a primary end-point for clinical trials, should possess the following characteristics: (i) be sensitive in patients with GERD; (ii) cover the frequency and intensity of typical and atypical GERD symptoms; (iii) be multidimensional (cover all symptom dimensions); (iv) have proven psychometric properties (validity, reliability and responsiveness); (v) be practical and economical; (vi) be self-assessed; (vii) use 'word pictures' which are easy to understand for patients; (viii) respond rapidly to changes (responsiveness over short time intervals); (ix) be used daily to assess changes during and after therapy; and (x) be valid in different languages for international use.
A literature review revealed five scales that met some of the above characteristics, but did not fulfil all criteria.
There is a need for a new evaluative tool for the assessment of GERD symptoms and their response to therapy.
胃食管反流病（GERD）在西方国家极为常见。由于大多数患者内镜检查无异常，因此评估症状严重程度、生活质量及其对治疗的反应变得愈发重要。自我评估症状问卷如今已成为临床试验中的关键工具。
评估现有GERD测量工具的有效性。
一种理想的GERD症状评估工具，适合作为临床试验的主要终点，应具备以下特征：（i）对GERD患者敏感；（ii）涵盖典型和非典型GERD症状的频率和强度；（iii）具有多维度（涵盖所有症状维度）；（iv）具备已证实的心理测量特性（有效性、可靠性和反应性）；（v）实用且经济；（vi）可自我评估；（vii）使用患者易于理解的“文字描述”；（viii）对变化反应迅速（短时间间隔内的反应性）；（ix）可每日用于评估治疗期间及之后的变化；以及（x）在不同语言中均有效，可供国际使用。
文献综述发现有五个量表符合上述部分特征，但未满足所有标准。
需要一种新的评估工具来评估GERD症状及其对治疗的反应。
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