Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Functional Dyspepsia Symptom Diary
研究概览
简要总结
Functional dyspepsia (FD) is a common functional gastrointestinal disease. Several patient-reported outcome questionnaires have been established to evaluate the severity of FD, including Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI). Functional Dyspepsia Symptom Diary (FDSD) is a newly symptom-focused patients-reported outcome measure raised by the Patient-Reported Outcome Consortium's Functional Dyspepsia Working Group. The association of the novel FDSD and other scores-related to FD has not been fully investigated. Furthermore, the severity of FD is varied among different patients. It remains unclear how the moderate and severe FD can be defined by the FDSD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old
- •Patients who met the Rome IV diagnostic criteria of FD
- •Normal upper endoscopy and abdominal ultrasonography within one year.
排除标准
- •1, Patients with local or systemic diseases which may cause dyspeptic symptoms:
- •Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.
- •Known acute or chronic diseases of liver or kidney
- •Obvious hematological abnormality, or endocrine and metabolic diseases
- •suspected incomplete or complete bowel obstruction
- •Known malignancy
- •Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
- •2, Pregnancy
- •3, Inability to give informed consent
结局指标
主要结局
Functional Dyspepsia Symptom Diary
时间窗: 1 day
The FDSD consists of 5 cardinal items (burning in the stomach, stomach pain, bloating, postprandial fullness, and early satiety) and 3 supplementary items (nausea, burping/belching rating, and burping/belching bother). Each item can be scored from 0 (no) to 10 (worst). Total Symptom Score includes the 5 cardinal items and ranges from 0 to 50.
次要结局
- Severity of FD judged by patients(1 day)
- Gastrointestinal Symptom Rating Scale (GSRS)(1 day)
- Dyspepsia Symptom Severity Index (DSSI)(1 day)
- Short Form of Nepean Dyspepsia Index (SF-NDI)(1 day)
- Hamilton Anxiety and Depression Scale(1 day)
- Severity of FD judged by physicians(1 day)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China