OBJECTIVES This study aimed to examine the validity of the modified Reflux Symptom Questionnaire-electronic Diary (mRESQ-eD) through patient input and psychometric testing of the questionnaire to support use in clinical trials in patients with persistent gastroesophageal reflux disease (GERD) and in accordance with Food and Drug Administration guidance on patient-reported outcome instruments. METHODS Cognitive interviews were conducted with patients (n = 30) to evaluate the interpretability and content validity of draft mRESQ-eD items. Patient data from a phase 2b clinical study (ClinicalTrials.gov identifier: NCT02637557) on persistent GERD served to aid in the construction of weekly scores for heartburn severity, regurgitation severity, and total GERD severity. These scores' psychometric properties were also evaluated. RESULTS Minor modifications were made to the draft mRESQ-eD based on patient feedback to improve interpretability and clarity of the instrument. Psychometric analysis suggested that an 8-item version of the mRESQ-eD was best suited to the clinical data. The internal consistency was found to be high (Coefficient ω = 0.95). Retest reliability and convergent validity were strong for a heartburn weekly severity score, regurgitation weekly severity score, and total GERD severity score. DISCUSSION The final 8-item mRESQ-eD is a reliable and valid instrument with good psychometric properties for use in clinical trials in patients with persistent GERD. The mRESQ-eD may be considered for inclusion in clinical trials for persistent GERD and potentially positioned, in consultation with Food and Drug Administration, as endpoints to characterize treatment benefit.

中文翻译：

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持续性胃食管反流病患者改良反流症状问卷-电子日记的评估和验证。

目的 本研究旨在通过患者输入和问卷的心理测试来检验改良的反流症状问卷 - 电子日记 (mRESQ-eD) 的有效性，以支持在持续性胃食管反流病 (GERD) 患者的临床试验中的使用，并根据与食品和药物管理局对患者报告结果工具的指导。方法 对患者 (n = 30) 进行认知访谈，以评估 mRESQ-eD 项目草案的可解释性和内容有效性。来自持续性 GERD 的 2b 期临床研究（ClinicalTrials.gov 标识符：NCT02637557）的患者数据有助于构建胃灼热严重程度、反流严重程度和总 GERD 严重程度的每周评分。还评估了这些分数的心理测量特性。结果 根据患者反馈对 mRESQ-eD 草案进行了细微修改，以提高仪器的可解释性和清晰度。心理测量分析表明，mRESQ-eD 的 8 项版本最适合临床数据。发现内部一致性很高（系数 ω = 0.95）。胃灼热每周严重程度评分、反流每周严重程度评分和 GERD 严重程度总评分的重测信度和收敛效度很强。讨论 最后的 8 项 mRESQ-eD 是一种可靠且有效的工具，具有良好的心理测量特性，可用于持续性 GERD 患者的临床试验。mRESQ-eD 可考虑纳入持续性 GERD 的临床试验，并可能在与食品和药物管理局协商后定位，