The epidemiology and treatment patterns of patients with Gastro-oesophageal reflux disease (GORD) in routine general practice.

Study type
Protocol
Date of Approval
Study reference ID
16_070
Lay Summary

Gastro-oesophageal reflux disease (GORD) is a digestive problem in which a weakness or relaxing of the muscle between the oesophagus (food pipe) and the stomach allows stomach acid to leak into the oesophagus. It is a long-lasting condition and, in severe cases, can cause permanent damage to the oesophagus.
Symptoms include heartburn, indigestion and acid reflux (stomach acid rising in the throat) and these can impact on patients' quality of life. The symptoms can be relieved using medication prescribed by the doctor or bought by the patients themselves over the counter. Drugs called proton-pump inhibitors, which reduce the production of stomach acid, are usually tried first. Other treatments for GORD include alginates, which work by forming a protective barrier on top of the stomach contents, preventing these from being regurgitated.
In this study we wish to use the Clinical Practice Research Datalink to identify patients with GORD and describe how it is treated and how it affects patients' health. We will select patients with a first diagnosis of GORD in 2009, allowing their records to be followed for up to five years.

Technical Summary

We aim to describe the epidemiology of patients diagnosed with gastro-oesophageal reflux disease (GORD), selecting patients who have a first diagnosis of GORD in 2009, have been registered for at least five years at an up-to-standard practice at the date of diagnosis, and are eligible for HES linkage. We will look at incident exposures of these patients and examine the distribution of age and sex. The rate of hospital admissions per 1000 patient years will also be calculated.
Patterns of treatment with proton pump inhibitors (PPIs) and prescribed alginates in patients diagnosed with GORD will also be described. Treatment paths will be observed for patients from their first prescription for an alginate or a PPI, or for a combination of PPI plus alginate, where these share a first prescription date. In addition, analyses will be performed on the switching patterns between two alginate product groups: commonly used, branded alginates and other alginate-containing products. Time to first switch will be compared between alginate groups using a Cox proportional hazards model.

Health Outcomes to be Measured

Patient and clinical characteristics at first GORD diagnosis Rates of hospital admission for GORD Baseline characteristics and treatment pathways in patients with GORD by first therapy type Switching patterns and time to switching between alginate product groups

Collaborators

Craig Currie - Chief Investigator - Cardiff University
Dafydd Williams - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences

Linkages

HES Admitted Patient Care