Structured management strategy usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trials
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 m...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2011-01-01
|
| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/1756283X10387060 |
| _version_ | 1818448099141484544 |
|---|---|
| author | Julio Ponce Vicente Garrigues Lars Agréus Erminio Tabaglio Michael Gschwantler Eliseo Güallar Mónica Tafalla Javier Nuevo Jan G. Hatlebakk |
| author_facet | Julio Ponce Vicente Garrigues Lars Agréus Erminio Tabaglio Michael Gschwantler Eliseo Güallar Mónica Tafalla Javier Nuevo Jan G. Hatlebakk |
| author_sort | Julio Ponce |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-14T20:14:07Z |
| format | Article |
| id | doaj.art-3bd97be597fa41a295b855f660c7fa4b |
| institution | Directory Open Access Journal |
| issn | 1756-283X 1756-2848 |
| language | English |
| last_indexed | 2024-12-14T20:14:07Z |
| publishDate | 2011-01-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj.art-3bd97be597fa41a295b855f660c7fa4b2022-12-21T22:48:53ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-283X1756-28482011-01-01410.1177/1756283X10387060Structured management strategy usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trialsJulio PonceVicente GarriguesLars AgréusErminio TabaglioMichael GschwantlerEliseo GüallarMónica TafallaJavier NuevoJan G. HatlebakkBackground: 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.https://doi.org/10.1177/1756283X10387060 |
| spellingShingle | Julio Ponce Vicente Garrigues Lars Agréus Erminio Tabaglio Michael Gschwantler Eliseo Güallar Mónica Tafalla Javier Nuevo Jan G. Hatlebakk Structured management strategy usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trials Therapeutic Advances in Gastroenterology |
| title | Structured management strategy usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trials |
| title_full | Structured management strategy usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trials |
| title_fullStr | Structured management strategy usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trials |
| title_full_unstemmed | Structured management strategy usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trials |
| title_short | Structured management strategy usual care for gastroesophageal reflux disease: rationale for pooled analysis of five European cluster-randomized trials |
| title_sort | structured management strategy usual care for gastroesophageal reflux disease rationale for pooled analysis of five european cluster randomized trials |
| url | https://doi.org/10.1177/1756283X10387060 |
| work_keys_str_mv | AT julioponce structuredmanagementstrategyusualcareforgastroesophagealrefluxdiseaserationaleforpooledanalysisoffiveeuropeanclusterrandomizedtrials AT vicentegarrigues structuredmanagementstrategyusualcareforgastroesophagealrefluxdiseaserationaleforpooledanalysisoffiveeuropeanclusterrandomizedtrials AT larsagreus structuredmanagementstrategyusualcareforgastroesophagealrefluxdiseaserationaleforpooledanalysisoffiveeuropeanclusterrandomizedtrials AT erminiotabaglio structuredmanagementstrategyusualcareforgastroesophagealrefluxdiseaserationaleforpooledanalysisoffiveeuropeanclusterrandomizedtrials AT michaelgschwantler structuredmanagementstrategyusualcareforgastroesophagealrefluxdiseaserationaleforpooledanalysisoffiveeuropeanclusterrandomizedtrials AT eliseoguallar structuredmanagementstrategyusualcareforgastroesophagealrefluxdiseaserationaleforpooledanalysisoffiveeuropeanclusterrandomizedtrials AT monicatafalla structuredmanagementstrategyusualcareforgastroesophagealrefluxdiseaserationaleforpooledanalysisoffiveeuropeanclusterrandomizedtrials AT javiernuevo structuredmanagementstrategyusualcareforgastroesophagealrefluxdiseaserationaleforpooledanalysisoffiveeuropeanclusterrandomizedtrials AT janghatlebakk structuredmanagementstrategyusualcareforgastroesophagealrefluxdiseaserationaleforpooledanalysisoffiveeuropeanclusterrandomizedtrials |