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

Julio Ponce, Vicente Garrigues, Erminio Tabaglio, Michael Gschwantler, Eliseo Güallar, Mónica Tafalla, Javier Nuevo, Jan G. Hatlebakk

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)11-26
Number of pages16
JournalTherapeutic Advances in Gastroenterology
Volume4
Issue number1
DOIs
StatePublished - Jan 2011

Keywords

  • Gastroesophageal reflux disease
  • GerdQ
  • Pooled analysis

ASJC Scopus subject areas

  • Gastroenterology

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