AstraZeneca R&D Mölndal, Mölndal, Sweden.
Clin Drug Investig. 2004;24(4):205-15. doi: 10.2165/00044011-200424040-00002.
Symptoms of heartburn and their impact on health-related quality of life (HR-QOL) are often evaluated in clinical trials. When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified.
To document the psychometric characteristics of the Italian translation of the Gastrointestinal Symptom-Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire.
152 consecutive patients with symptoms of heartburn (mean +/- SD age 46.5 +/- 16.2 years; 40.1% males) completed the Italian translation of GSRS, the heartburn version of QOLRAD, the 36-item Short-Form health survey (SF-36), and the Hospital Anxiety and Depression (HAD) scale.
The internal consistency reliability of GSRS ranged from 0.62 to 0.76 and of QOLRAD from 0.77 to 0.89. The relevant domains of the GSRS ('Reflux', 'Abdominal Pain' and 'Indigestion') and QOLRAD domain scores significantly correlated. GSRS domains 'Reflux' and 'Abdominal Pain' strongly correlated (negatively) with most of the domains of the SF-36. Similarly, all QOLRAD domains significantly correlated with all SF-36 domains.
The psychometric characteristics of the Italian translations of GSRS and QOLRAD were found to be good, with satisfactory reliability and validity.
烧心症状及其对健康相关生活质量（HR-QOL）的影响通常在临床试验中进行评估。当问卷被翻译成新的语言时，需要进行语言验证，但除非已经验证了心理测量学特征，否则这是不够的。
记录胃肠道症状评分量表（GSRS）和反流和消化不良生活质量（QOLRAD）问卷意大利语翻译的心理测量学特征。
152 例烧心症状连续患者（平均年龄 +/- SD 46.5 +/- 16.2 岁；40.1%为男性）完成了 GSRS 烧心版、QOLRAD、36 项简明健康调查问卷（SF-36）和医院焦虑抑郁量表（HAD）的意大利语翻译。
GSRS 的内部一致性信度范围为 0.62 至 0.76，QOLRAD 的内部一致性信度范围为 0.77 至 0.89。GSRS 的相关域（“反流”、“腹痛”和“消化不良”）和 QOLRAD 域评分显著相关。GSRS 域“反流”和“腹痛”与 SF-36 的大多数域强烈负相关。同样，QOLRAD 的所有域都与 SF-36 的所有域显著相关。
GSRS 和 QOLRAD 的意大利语翻译的心理测量学特征被发现良好，具有令人满意的可靠性和有效性。
