Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity

Study Overview
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Brief Summary
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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.

Official Title
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Association of Functional Dyspepsia Symptom Diary Score and Other Scores Related to Functional Dyspepsia and Its Severity

Conditions
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Functional Dyspepsia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 18-70 years old 2. Patients who met the Rome IV diagnostic criteria of FD 3. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Dyspepsia Symptom Diary | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptom Rating Scale (GSRS) | The GSRS contains 15 items. All individual items are scored on a 7-point Likert scale (1 = not at all to 7 = extremely) and are subsequently clustered into five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation); higher scores indicate more severe symptoms. | 1 day | 
| Dyspepsia Symptom Severity Index (DSSI) | The DSSI contains 20 items. All individual items are scored on a 5-point Likert scale (0 = not at all to 4 = extremely) and are subsequently clustered into three domains (Dysmotility-like, Reflux-like, and Ulcer-like); higher scores indicate more severe symptoms. | 1 day | 
| Short Form of Nepean Dyspepsia Index (SF-NDI) | The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms (stomach problems) on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50. | 1 day | 
| Hamilton Anxiety and Depression Scale | Anxiety and depression of patients are assessed by using Hamilton Anxiety and Depression Scale. | 1 day | 
| Severity of FD judged by patients | Patients were asked to rate the severity of FD as mild, moderate, and severe. | 1 day | 
| Severity of FD judged by physicians | Physicians rated the patients' severity of FD as mild, moderate, and severe. | 1 day |