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 Guallar, Mónica Tafalla, Javier Nuevo, Jan G. Hatlebakk

Research output: Contribution to journalArticle

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 - 2011

Fingerprint

Gastroesophageal Reflux
Primary Health Care
Proton Pump Inhibitors
Norway
Esomeprazole
Heartburn
Austria
Disease Management
Sweden
Spain
Italy
Endoscopy
Health Status
Therapeutics
Referral and Consultation
Outcome Assessment (Health Care)
Guidelines
Delivery of Health Care
Physicians

Keywords

  • Gastroesophageal reflux disease
  • GerdQ
  • Pooled analysis

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Structured management strategy versus usual care for gastroesophageal reflux disease : Rationale for pooled analysis of five European cluster-randomized trials. / Ponce, Julio; Garrigues, Vicente; Tabaglio, Erminio; Gschwantler, Michael; Guallar, Eliseo; Tafalla, Mónica; Nuevo, Javier; Hatlebakk, Jan G.

In: Therapeutic Advances in Gastroenterology, Vol. 4, No. 1, 2011, p. 11-26.

Research output: Contribution to journalArticle

Ponce, Julio ; Garrigues, Vicente ; Tabaglio, Erminio ; Gschwantler, Michael ; Guallar, Eliseo ; Tafalla, Mónica ; Nuevo, Javier ; Hatlebakk, Jan G. / Structured management strategy versus usual care for gastroesophageal reflux disease : Rationale for pooled analysis of five European cluster-randomized trials. In: Therapeutic Advances in Gastroenterology. 2011 ; Vol. 4, No. 1. pp. 11-26.
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