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

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.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China
      • Lanzhou University Second Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Diseases
    • Xi'an, Shaanxi, China, 710032
      • The Second Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients 18-70 years old who met the Rome IV diagnostic criteria of FD with normal upper endoscopy and abdominal ultrasonography within one year were eligible for our study. Patients with local or systemic diseases which may cause dyspeptic symptoms were excluded. Patients who were pregnant or unable to give informed consent were also excluded.

Description

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:

  1. Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.
  2. Known acute or chronic diseases of liver or kidney
  3. Obvious hematological abnormality, or endocrine and metabolic diseases
  4. suspected incomplete or complete bowel obstruction
  5. Known malignancy
  6. Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
• 2, Pregnancy
• 3, Inability to give informed consent

Study Plan

How is the study designed?

What is the study measuring?

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
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
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
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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• Shi X, Luo H, Wang X, Ren G, Zhang L, Tao Q, Liang S, Liu N, Huang X, Zhang X, Deng H, Qin W, Kang X, Pan Y, Fan D. Functional dyspepsia symptom diary is correlated with other questionnaires and associated with severity in patients with functional dyspepsia: a multicenter, prospective observational study. J Gastroenterol Hepatol. 2022 Jul;37(7):1298-1306. doi: 10.1111/jgh.15854. Epub 2022 Apr 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2020
• Primary Completion (ACTUAL): June 20, 2021
• Study Completion (ACTUAL): June 20, 2021

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (ACTUAL): July 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: KY20202087-F-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No