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首页> 外文期刊>Alimentary pharmacology & therapeutics. >Development and field testing of a novel patient-reported outcome measure of dysphagia in patients with eosinophilic esophagitis
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Development and field testing of a novel patient-reported outcome measure of dysphagia in patients with eosinophilic esophagitis

机译：嗜酸性粒细胞性食管炎患者吞咽困难的新型患者报告结局测量方法的开发和现场测试

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Background Dysphagia is the hallmark of eosinophilic esophagitis (EoE), but no validated dysphagia instruments in this population exist. Aim To develop and field test a patient-reported outcome (PRO) for dysphagia in subjects with EoE. Methods This was a multi-centre/multi-phase prospective study. The first phase developed a dysphagia questionnaire using qualitative methods. The second phase was a 30-day field trial to test the instrument and assess content validity. Adolescents and adults with EoE, active symptoms of dysphagia and oesophageal eosinophilia (≥15 eosinophils per high-power field) were enrolled. Solid-food-avoidance days, dysphagia days and actions taken to get relief were recorded. A dysphagia score was calculated and compared to the Straumann Dysphagia Instrument (SDI). Results Ten adolescents and 10 adults were included in the first phase and the Dysphagia Symptom Questionnaire (DSQ), a three-item daily electronic diary, was developed. In the second phase, 35 subjects finished the field trial (18 adults, 17 adolescents, mean age 24, 54% male, 95% white, 54% currently on topical corticosteroids). The median number of dysphagia days per week was 2 for adolescents vs. 4 for adults (P < 0.001), and 2 for those on topical steroids vs. 4 for those not on topical steroids (P < 0.001). The DSQ score strongly correlated with the number of dysphagia days (R = 0.96; P < 0.001) and the SDI (R = 0.77; P < 0.001). Conclusions The DSQ, a three-question patient-reported outcome, was successfully developed and field tested. The DSQ had content validity and the score accurately measured dysphagia frequency and intensity. The Dysphagia Symptom Questionnaire is suitable for use in clinical trials of EoE patients with dysphagia.
机译：背景吞咽困难是嗜酸性食管炎（EoE）的标志，但该人群中不存在经过验证的吞咽困难手段。目的开发和现场测试EoE患者吞咽困难的患者报告结果（PRO）。方法这是一个多中心/多阶段的前瞻性研究。第一阶段使用定性方法开发了吞咽困难问卷。第二阶段是为期30天的现场试验，以测试仪器并评估内容的有效性。纳入有EoE，吞咽困难和食道嗜酸性粒细胞增多症（每个高倍视野中嗜酸性粒细胞≥15个）的活跃症状的青少年和成年人。记录避免固体食物的日子，吞咽困难的日子以及为减轻痛苦而采取的行动。计算吞咽困难评分并将其与Straumann吞咽困难仪器（SDI）进行比较。结果第一阶段包括十名青少年和十名成人，并编制了一项每日三项电子日记-吞咽困难症状问卷（DSQ）。在第二阶段中，有35位受试者完成了现场试验（18位成人，17位青少年，平均年龄为24岁，54％的男性，95％的白人，54％的目前使用局部糖皮质激素治疗）。青少年每周吞咽困难的中位数为2天，成人为4天（P <0.001），局部类固醇激素为2个，非局部类固醇激素为4个（P <0.001）。 DSQ评分与吞咽困难天数（R = 0.96; P <0.001）和SDI（R = 0.77; P <0.001）密切相关。结论DSQ是一个由患者提出的三个问题的结局，已成功开发并进行了现场测试。 DSQ具有内容效度，并且评分能够准确测量吞咽困难的频率和强度。吞咽困难症状问卷适用于吞咽困难的EoE患者的临床试验。

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