Outcomes for Patients With Gastro-Esophageal Reflux Disease

NCT03824548 | Unknown DMC

• 1 other identifier: HLT-RWE-GERD-001
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief Summary

Gastro-esophageal reflux disease (GERD), the most common cause of erosive esophagitis (EE), remains highly prevalent worldwide. GERD poses substantial burden on both patients and society. EE treatment patterns and unmet needs have been well-studied overseas, but evidence gaps still exist in China. To fill these evidence gaps, real-world evidence for GERD and EE are needed. To understand GERD market we will analysis :Patient profile,GERD patient journey within hospital (first present, get diagnosed, receive initial and maintenance treatment),medication cost,department differentiation. To investigate current treatment patterns of GERD / EE in China we will analysis: Current agents used and treatment duration in clinical practice treatment patterns by different reimbursement status treatment pattern by EE/NERD. To get healing rate of EE we will analysis: Real-world efficacy of the current standard treatment (i.e. PPIs) for patient with two test results of gastroscopy. The data required for this project are accessible in hospital electronic system; no specific data collection tools or methods are required for this project design. Only algorithms for retrieving and extracting eligible patients' records are required and will be developed by HLT based on the eligibility criteria defined in this protocol.

Conditions

Gastro-esophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of GERD patients with an EE diagnosis confirmed by physician judgment vs. endoscopy

  oAnalysis can be stratified by age group, sex, and health plan type to investigate possible differences in diagnostic practices based on these related patient characteristics.

  oOnly patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.

Secondary Outcomes (1)

• Similarly, descriptive statistics will also be presented for secondary endpoints as the analysis further examines treatment use and proxy indicators assessing real-world treatment efficacy.

  Only patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.

Interventions

this is non-intervention study, there is no intervention drug or device in this study. OTHER

this is exactly a non-interventional study, no intervention during the whole study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The overall analysis population will consist of patients of all ages who were diagnosed with GERD from January 2015 to December 2017.

You may qualify if:

• Medical records of GERD, NERD and/or EE diagnoses （ICD code scope will be confirmed later）from January 1st, 2015 to December 31st, 2017.
• oGERD is typically characterized by symptoms of heartburn and acid regurgitation. A diagnosis of EE or NERD can only be confirmed upon endoscopic examination.
• All ages, males or females
• A primary diagnosis of GERD/NERD/EE
• For treatment patterns, patients are also required to have received one episode of treatment during the analysis period.
• For RW treatment efficacy, the population will be restricted to the EE treatment population who underwent at least two endoscopy examinations.

You may not qualify if:

• A post-operative diagnosis of gastrointestinal cancers
• A diagnosis of esophageal foreign bodies or neoplasms
• A history of gastric or esophageal surgery
• Zollinger-Ellison syndrome
• Primary esophageal motility disorders (ex: achalasia)
• Esophageal strictures
• Eosinophilic esophagitis
• Identified as pregnant or lactating
• Hospitalized (inpatient) patients (to be confirmed by expert.) due to GERD as primary or secondary diagnosis

Sponsors & Collaborators

• Tianjin Happy Life Technology Co., Ltd.: lead

Study Sites (1)

Yuan Na

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: January 17, 2019
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)