TY - JOUR
T1 - Structured management strategy versus usual care for gastroesophageal reflux disease
T2 - Rationale for pooled analysis of five European cluster-randomized trials
AU - Ponce, Julio
AU - Garrigues, Vicente
AU - Tabaglio, Erminio
AU - Gschwantler, Michael
AU - Güallar, Eliseo
AU - Tafalla, Mónica
AU - Nuevo, Javier
AU - Hatlebakk, Jan G.
N1 - Funding Information:
This study was supported by AstraZeneca, the manufacturer of esomeprazole. We thank Jackie Campbell, from inScience Communications (a Wolters Kluwer business), who provided medical writing support funded by AstraZeneca.
PY - 2011/1
Y1 - 2011/1
N2 - 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.
AB - 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.
KW - Gastroesophageal reflux disease
KW - GerdQ
KW - Pooled analysis
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U2 - 10.1177/1756283X10387060
DO - 10.1177/1756283X10387060
M3 - Article
C2 - 21317991
AN - SCOPUS:80052367622
SN - 1756-283X
VL - 4
SP - 11
EP - 26
JO - Therapeutic Advances in Gastroenterology
JF - Therapeutic Advances in Gastroenterology
IS - 1
ER -