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Structured Diagnostic and Treatment Approach Versus the Usual Primary Care Approach in Patients With Gastroesophageal Reflux Disease: A Cluster-randomized Multicenter Study

Bergquist, Henrik MD, PhD*; Agréus, Lars MD, PhD; Tillander, Lotta MD; Johnsson, Folke MD, PhD§; Sörngård, Heléne BSc; Sjöstedt, Svante MD, PhD; Hellström, Per M. MD, PhD

Journal of Clinical Gastroenterology: August 2013 - Volume 47 - Issue 7 - p e65–e73
doi: 10.1097/MCG.0b013e31827d7782
ONLINE ARTICLES: Original Articles

Goals: To compare the clinical outcomes of gastroesophageal reflux disease (GERD) patients treated with an implemented new structured pathway (NSP) or according to existing local clinical practices [old clinical pathway (OCP)].

Background: GERD is a major challenge at the primary care level.

Study: Primary care centers (n=24) were cluster randomized to handle patients suffering from symptoms suggestive of GERD according to the NSP (n=97) or the OCP (n=134). In the NSP, the GerdQ questionnaire score was used both for diagnosis and management including treatment. We used validated questionnaires to evaluate disease symptoms, quality of life, and costs at inclusion and at follow-up 2 to 6 months later.

Results: On the basis of the Reflux Disease Questionnaire, 56% of the patients treated with the NSP reported total symptom relief at the follow-up compared with 33% in the OCP group (P=0.0013). The reflux symptoms after treatment affected daily activities to a lesser extent in the patients in the NSP group compared with the OCP group (10% vs. 13%, respectively, P=0.01). The utility score of the EuroQoL-5D questionnaire improved more in the NSP group than in the OCP group (0.05 vs. 0.02, respectively, P<0.001). The patients in the NSP group had an approximately 50% lower average total cost for GERD-related health care resources compared with the OCP group [301 Swedish Kronor (SEK) vs. 588 SEK, respectively, NS].

Conclusions: The management of GERD patients in primary care centers using a structured clinical pathway and the results of the GerdQ improves the clinical outcome compared with prevailing local routines (NCT00842387).

*Department of ENT/H&N Surgery, Sahlgrenska University Hospital

Lorensberg Primary Care Center, Gothenburg

Karolinska Institutet, Huddinge

§Skåne University Hospital, Lund

AstraZeneca Nordic, Södertälje

Department of Medical Sciences, Uppsala University, Uppsala, Sweden

Supported by AstraZeneca. AstraZeneca was involved in the planning and performance of the study, analysis of data, and writing of the manuscript.

H.B. has worked as a consultant and lecturer for AstraZeneca and MSD. L.A. received unrestricted research grants from AstraZeneca and also gave salaried lectures for AstraZeneca, MSD (by a patient organization), and Kibom AB. H.S. is an employee of AstraZeneca at the time of the study. S.S. was an employee of AstraZeneca. P.M.H. has lectured at AstraZeneca. The remaining authors declare that they have nothing to disclose.

Reprints: Henrik Bergquist, MD, PhD, Department of ENT/H&N Surgery, Sahlgrenska University Hospital, Gothenburg S-413 45, Sweden (e-mail:

Received May 20, 2012

Accepted November 9, 2012

© 2013 by Lippincott Williams & Wilkins