An observational study for real world prescription patterns for the maintenance treatment of gastroesophageal reflux disease and survey on patient's preference
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0005810
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Background/Aims Gastroesophageal reflux disease (GERD) is a common chronic gastrointestinal disorder that typically requires long-term maintenance therapy. However, little is known about patient preferences and satisfaction and real-world prescription patterns regarding maintenance therapy for GERD. Methods This observational, cross-sectional, multicenter study involved patients from 18 referral hospitals in Korea. We surveyed patients who had been prescribed proton pump inhibitors (PPIs) for GERD for at least 90 days with a minimum follow-up duration of 1 year. The main outcome was overall patient satisfaction with different maintenance therapy modalities. Results A total of 197 patients were enrolled. Overall patient satisfaction, patient preferences, and GERD health-related quality of life scores did not significantly differ among the maintenance therapy modality groups. However, the on-demand therapy group experienced a significantly longer disease duration than the continuous therapy group. The continuous therapy group demonstrated a lower level of awareness of potential adverse effects associated with PPIs than the on-demand therapy group but received higher doses of PPIs than the on-demand therapy group. The prescribed doses of PPIs also varied based on the phenotype of GERD, with higher doses prescribed for non-erosive reflux disease than erosive reflux disease. Conclusion Although overall patient satisfaction did not significantly differ among the different PPI maintenance therapy modality groups, awareness of potential adverse effects was significantly different between the on-demand and continuous therapy groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 197
1. Patient with gastroesophageal reflux disease, adult males and females aged 19 years or older who have been prescribed proton pump inhibitors for 90 days or more during the same period of follow-up observation for the past 12 months or longer as of the date of written consent
2. Patient whose symptoms are recorded for typical symptoms of gastroesophageal reflux disease (heartburn or acid reflux) in medical records for the same period
3. Patient who can write a questionnaire
4. Patient who had voluntarily decided participation, and provided written consent
1.Patient taking proton pump inhibitors for diseases other than gastroesophageal reflux disease (peptic ulcer, peptic ulcer prevention, eosinophilic esophagitis, functional dyspepsia, etc.)
2.Patient with primary or secondary esophageal motility disorder
3.Patient with surgery related to esophagus, stomach, duodenum
4.Patient with a history of untreated malignant tumors
5.Patient who has significant disease with liver, kidney, cardiac, respiratory, endocrine, central nervous system
6.Patient with a history of drug or alcohol abuse (within 1 year)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall patient's satisfaction according to each prescription pattern for the maintenance treatment of proton pump inhibitors at the actual clinical field
- Secondary Outcome Measures
Name Time Method Patient's satisfaction with the degree of symptom control of the current medication pattern;Patient's satisfaction with the convenience of taking the current medication pattern;The patient's preferred maintenance treatment pattern of proton pump inhibitors;Side effects associated with maintenance treatment of proton pump inhibitors