Jung Hye-Kyung, Choi Myung-Gyu, Baek Myung-Ki, Wu Justin C Y
Department of Internal Medicine, Ewha Womans University, College of Medicine, Seoul, Korea.
Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
J Neurogastroenterol Motil. 2018 Oct 1;24(4):584-592. doi: 10.5056/jnm18085.
BACKGROUND/AIMS: There is uncertainty about how to measure outcomes reported by patients in gastroesophageal reflux disease (GERD). This study was conducted to develop an instrument and to determine of the definition of respondent for a patient reported outcomes to assess the efficacy of a treatment used for GERD treatment.
A structural process has developed a self-evaluation questionnaire for GERD (SEQ-GERD); health-related quality of life questionnaire for GERD (GERD-QOL) was translated through cross-cultural validation. Two-week reproducibility was evaluated and construct validity was assessed by correlating the SEQ-GERD with the Patient Assessment of Gastrointestinal Disorders (PAGI-SYM), the reflux disease questionnaire (RDQ), and GERD-QOL. Changes in SEQ-GERD scores were compared to assess the discriminative validity following 4 weeks of proton pump inhibitor administration.
A total of 83 Korean patients were included (mean age 46 ± 14 years, females 61.4%). The internal consistency of the 19-item SEQ-GERD was good (alpha = 0.60-0.94) and the test-retest reliability was high (intra-class correlation coefficient = 0.67-0.95). The SEQ-GERD highly correlated with the GERD domain of the PAGI-SYM (correlation coefficient = 0.894, < 0.001), the RDQ-GERD ( = 0.877, < 0.001), and GERD-QOL ( = -0.536, < 0.05). SEQ-GERD scores significantly varied according to the overall treatment effectiveness scale of drug responsiveness and significantly decreased after drug treatment (mean differences according to the overall treatment effectiveness scale, = 0.020).
This study supports that SEQ-GERD is reliable and valid, and can be used to evaluate the treatment response in patients with GERD.
背景/目的：对于如何衡量胃食管反流病（GERD）患者报告的结局存在不确定性。本研究旨在开发一种工具，并确定用于评估GERD治疗所用疗法疗效的患者报告结局的应答者定义。
通过结构化流程开发了GERD自我评估问卷（SEQ-GERD）；GERD健康相关生活质量问卷（GERD-QOL）通过跨文化验证进行翻译。评估了两周的可重复性，并通过将SEQ-GERD与胃肠道疾病患者评估量表（PAGI-SYM）、反流病问卷（RDQ）和GERD-QOL进行相关性分析来评估结构效度。比较SEQ-GERD评分的变化，以评估质子泵抑制剂给药4周后的区分效度。
共纳入83例韩国患者（平均年龄46±14岁，女性占61.4%）。19项SEQ-GERD的内部一致性良好（α=0.60-0.94），重测信度较高（组内相关系数=0.67-0.95）。SEQ-GERD与PAGI-SYM的GERD领域（相关系数=0.894，<0.001）、RDQ-GERD（=0.877，<0.001）和GERD-QOL（=-0.536，<0.05）高度相关。SEQ-GERD评分根据药物反应性的总体治疗有效性量表有显著差异，药物治疗后显著降低（根据总体治疗有效性量表的平均差异，=0.020）。
本研究支持SEQ-GERD是可靠且有效的，可用于评估GERD患者的治疗反应。
