Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Proportion of EE patients and NERD patients by treatment use | Only patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period. |
Not provided
Inclusion Criteria:
oGERD is typically characterized by symptoms of heartburn and acid regurgitation. A diagnosis of EE or NERD can only be confirmed upon endoscopic examination.
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.
Exclusion Criteria:
- No exclusion criteria will be applied for investigating diagnosis since all patients diagnosed with GERD, NERD, or EE should be captured regardless of whether they have medical conditions that affect their treatments.
A patient will not be eligible for investigating treatment patterns and RW treatment efficacy if he/she has any of the following exclusion criterion:
Not provided
Not provided
Not provided
Not provided
The overall analysis population will consist of patients of all ages who were diagnosed with GERD from January 2015 to December 2017.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuan Na | Recruiting | Beijing | Beijing Municipality | 100000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D004066 | Digestive System Diseases |