Structured diagnostic and treatment approach versus the usual primary care approach in patients with gastroesophageal reflux disease: a cluster-randomized multicenter study

J Clin Gastroenterol. 2013 Aug;47(7):e65-73. doi: 10.1097/MCG.0b013e31827d7782.

Abstract

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).

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cluster Analysis
  • Female
  • Follow-Up Studies
  • Gastroesophageal Reflux / diagnosis*
  • Gastroesophageal Reflux / economics
  • Gastroesophageal Reflux / therapy*
  • Humans
  • Male
  • Middle Aged
  • Primary Health Care / economics
  • Primary Health Care / methods*
  • Proton Pump Inhibitors / therapeutic use*
  • Quality of Life
  • Severity of Illness Index*
  • Surveys and Questionnaires*
  • Treatment Outcome

Substances

  • Proton Pump Inhibitors

Associated data

  • ClinicalTrials.gov/NCT00842387