Structured management strategy versus usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trials

Abstract

Background: Gastroesophageal reflux disease (GERD) has a major impact at the primary care level and there is a need to evaluate whether the diagnosis and therapeutic management of GERD in Europe needs to be improved.

Methods: This project was designed to test the hypothesis that a new primary care management strategy would improve outcomes for patients with GERD, compared with usual care, in Europe. The analysis pools five separate cluster-randomized studies conducted in Austria, Italy, Norway, Spain and Sweden. These studies used a strategy based on the self-administered GerdQ questionnaire to stratify adult patients with symptoms of heartburn or regurgitation according to the frequency and impact of symptoms. A score of ≥8 indicates a high probability of suffering GERD. Patients with a GerdQ impact score ≤2 were treated with generic proton-pump inhibitors according to local guidance, and patients with an impact score ≥3 were treated with esomeprazole 40 mg once daily.

Results: In total, 2400 patients were enrolled across the five studies. The protocols were modified by individual countries according to their local guidelines/requirements. In Norway, the new management strategy was compared with traditional routine endoscopy and 24-hour pH-metry, and encompassed proton-pump inhibitor reimbursement restrictions. Outcome measures differed by country, but included control of GERD symptoms, self-rated health status and work productivity, treatment changes, specialist referrals and physician adherence. GERD-related use of healthcare resources was also evaluated.

Conclusion: The pooled analysis will determine whether a locally adapted primary care management strategy for GERD, using GerdQ as a patient-tailored diagnostic and therapeutic evaluation tool, is beneficial compared with usual care across five countries with different standard approaches to GERD management and control.

Keywords: GerdQ; gastroesophageal reflux disease; pooled analysis.

Figure 1.

Standard study flow chart.

Figure A1.1.

Study flow chart for Austria.

Figure A1.2.

Study pathway for Austria.

Figure A1.3.

Study flow chart for Spain.

Figure A1.4.

Study pathway for Spain.

Figure A1.5.

Study flow chart for Italy.

Figure A1.6.

Study pathway for Italy.

Figure A1.9.

Standard pathway for Norway.

Figure A1.7.

Study flow chart for Norway.

Figure A1.8.

Structured pathway for Norway.

Figure A1.10.

Study flow chart for Sweden.

Figure A1.11.

Study pathway for Swedish patients with GERD who had not received previous treatment.

Figure A1.12.

Study pathway for Swedish patients with GERD symptoms despite PPI therapy.