Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Dyspepsia
- Sponsor
- Air Force Military Medical University, China
- Enrollment
- 500
- Locations
- 3
- Primary Endpoint
- Functional Dyspepsia Symptom Diary
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Yanglin Pan
Associated professor
Air Force Military Medical University, China
Eligibility Criteria
Inclusion Criteria
- •18-70 years old
- •Patients who met the Rome IV diagnostic criteria of FD
- •Normal upper endoscopy and abdominal ultrasonography within one year.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Functional Dyspepsia Symptom Diary
Time Frame: 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.
Secondary Outcomes
- 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)