The effect of on demand versus continuous use of proton pump inhibitors on reflux symptoms, quality of life and self-rated health in patients with gastro-oesophageal reflux disease

Gastro-oesophageal reflux disease (GORD) includes a spectrum of disorders
mainly caused by the retrograde flow of acid gastric contents form the stomach
into the oesophagus, causing symptoms and/or oesophageal mucosal damage.
Heartburn and acid regurgitation (a bitter burning taste at the back of the
mouth) are the most typical symptoms of GORD. GORD is a chronic disease
(prevalence 10-20 % in Europe) with a negative effect on quality of life (QoL).
GORD is mainly treated in primary care with a proton pump inhibitor (PPI) eg 20
mg omeprazole once or twice daily or on demand. The data on which treatment
regime is superior is conflicting and this lack of knowledge is likely to be
related to the difficulties of performing large randomised controlled trials in
primary care. In addition, patient reported outcomes such as symptom frequency
and severity, QoL and self-rated health are important measures but are rarely
used in primary care today. The goal of the TRANSFoRm project is to develop
tools to facilitate the conduction of RCTs in primary care, including the
collection of both care reported outcomes and patient reported outcomes.

Objective 1: To investigate the difference in prescribing proton pump
inhibitors continuously rather than on demand in patient reported reflux
symptoms, quality of life and self-rated health.

Objective 2: To investigate whether the use of electronic tools for data
collection results in a higher recruitment rate than standard paper-based
procedures.

Randomized controlled trial (Objective 1) within a clustered randomized
controlled trial (Objective 2).

Patients will be randomized to either continuous use of PPI (20 mg omeprazole
daily) or on demand (20 mg Omeprazol on demand, maximum daily dose is 40 mg)
(Objective 1). Primary health care centres enrolling patients will be
randomized to perform the study with the use of electronic tools for data
collection or the use of standard trial methods for data collection (Objective
2).

The patient will be randomized to one of two standard treatments of GORD. Thus,
the intervention per se cannot be considered a burden for the patient. The
patient will complete questionnaires for patient reported outcome measures at
the start of the study and after 8 weeks, which is estimated will take
approximately 20 minutes to complete. Knowledge of which of these standard
treatments gives the most symptom relief will be used to further clarify
treatment regiments for GORD and thus be used to improve quality of care for
patients with GORD in primary care across Europe. Thus, the benefits of the
study are deemed to exceed the burden and risks for participating patients.