Kleinman Leah, Rothman Margaret, Strauss Richard, Orenstein Susan R, Nelson Suzanne, Vandenplas Yvan, Cucchiara Salvatore, Revicki Dennis A
Center for Health Outcomes Research, United BioSource Corporation, Seattle, Washington 98121, USA.
Clin Gastroenterol Hepatol. 2006 May;4(5):588-96. doi: 10.1016/j.cgh.2006.02.016.
BACKGROUND & AIMS: Gastroesophageal reflux disease (GERD) is frequently experienced by infants, and disease-specific measures are needed to evaluate treatment benefits. We revised the Infant Gastroesophageal Reflux Questionnaire (I-GERQ) on the basis of information from parents of infants with GERD and physicians and subjected it to a psychometric evaluation.
A 3-week, multi-country observational study of 185 caregivers of infants younger than 18 months with GERD and 93 caregivers of control infants was conducted. Caregivers completed the I-GERQ-R weekly and recorded symptoms in a Daily Diary. Caregivers and physicians rated global disease severity and change in overall GERD symptoms.
Slightly more than half of infants were male with a mean age of 6.7 months, and most infants had been diagnosed with GERD for a little more than 2 months (mean, 66.7 days). Internal consistency reliability for the I-GERQ-R ranged from 0.86 to 0.87, and test-retest reliability was 0.85. Construct validity was demonstrated by significant differences between cases and controls on all item scores (all P<.01) and the total score (P<.0001), correlations with relevant Daily Diary symptoms, and both physician-rated (P<.05) and caregiver-rated disease severity (P<.05). Mean baseline to 3-week I-GERQ-R change scores for those infants whose caregivers reported improvement was -5.7 compared with -0.3 for those whose caregivers reported worse/same (P<.001). Physician ratings of change resulted in similar findings, with mean changes of -5.7 for those rated improved and -0.1 for those rated as worse/same (P<.0001).
This study demonstrated the I-GERQ-R is a reliable, valid, and clinically responsive measure of infant GERD symptoms.
婴儿经常出现胃食管反流病（GERD），需要采用针对该疾病的措施来评估治疗效果。我们根据GERD婴儿的父母及医生提供的信息，对婴儿胃食管反流问卷（I-GERQ）进行了修订，并对其进行了心理测量学评估。
对185名18个月以下GERD婴儿的照料者和93名对照婴儿的照料者进行了为期3周的多国观察性研究。照料者每周完成I-GERQ-R，并在每日日记中记录症状。照料者和医生对整体疾病严重程度和GERD总体症状变化进行评分。
略多于一半的婴儿为男性，平均年龄为6.7个月，大多数婴儿被诊断为GERD的时间略超过2个月（平均66.7天）。I-GERQ-R的内部一致性信度在0.86至0.87之间，重测信度为0.85。病例组和对照组在所有项目得分（均P<0.01）和总分（P<0.0001）上存在显著差异，与相关每日日记症状的相关性，以及医生评分（P<0.05）和照料者评分的疾病严重程度（P<0.05），均证明了结构效度。照料者报告症状改善的婴儿，从基线到3周的I-GERQ-R平均变化分数为-5.7，而照料者报告症状恶化/不变的婴儿为-0.3（P<0.001）。医生对变化的评分也得出了类似结果，评为改善的婴儿平均变化为-5.7，评为恶化/不变的婴儿为-0.1（P<0.0001）。
本研究表明，I-GERQ-R是一种可靠、有效的测量婴儿GERD症状的方法，且对临床有反应。
