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首页> 外文期刊>Therapeutic advances in gastroenterology. >Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population
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Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population

机译：在临床研究人群中以腹泻为主的肠易激综合征的最新患者报告结局工具的评估和性能

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To evaluate the psychometric properties of the newly developed seven-item Irritable Bowel Syndrome – Diarrhea predominant (IBS-D) Daily Symptom Diary and four-item Event Log using phase II clinical trial safety and efficacy data in patients with IBS-D. This instrument measures diarrhea (stool frequency and stool consistency), abdominal pain related to IBS-D (stomach pain, abdominal pain, abdominal cramps), immediate need to have a bowel movement (immediate need and accident occurrence), bloating, pressure, gas, and incomplete evacuation. Psychometric properties and responsiveness of the instrument were evaluated in a clinical trial population [ ClinicalTrials.gov identifier: NCT01494233]. A total of 434 patients were included in the analyses. Significant differences were found among severity groups (p p These analyses provide evidence of the psychometric properties of the IBS-D Daily Symptom Diary and Event Log in a clinical trial population.
机译：使用II期临床试验安全性和有效性数据评估新开发的七项肠易激综合症-腹泻为主（IBS-D）每日症状日记和四项事件日志的心理测量特性。该仪器可测量腹泻（大便次数和大便的稠度），与IBS-D相关的腹痛（胃痛，腹痛，腹部绞痛），排便的迫切需要（立即需要和意外发生），腹胀，压力，气体，并且疏散不彻底。在临床试验人群中评估了该仪器的心理测量特性和响应能力[ClinicalTrials.gov标识符：NCT01494233]。分析总共包括434名患者。在严重程度组之间发现了显着差异（p p这些分析提供了IBS-D每日症状日记和事件日志在临床试验人群中的心理计量学特性的证据。

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