What is the Predictive Value of the Reflux Impact Scale (PREDICT)

What is the Value of the Use of Validated Questionnaire (Reflux Impact Scale) for Predicting Treatment Success With PPI

Gastric distress is a common phenomenon in our society. Heartburn and regurgitation occur daily in about 7% of the adult population,weekly 14-20% pf the adults and monthly in 34-44% of adults. The yearly prevalence of recurrent stomach complaints are frequent reason for consulting a primary care physician and are an important reason for using OTC medication. A good diagnosis is important as functional GERD with possible complications such as strictures and Barrett's esophagus or ulcer disease with life threatening complications such as bleeding & perforations. The clinical diagnosis of reflux disease is mainly based on symptom evaluation. This, however, is hindered by the variety of complaints with different etiology. Treatment with a proton pump inhibitor can be used to confirm the diagnosis reflux disease. A major part of the patients with acid related stomach complaints indeed will experience symptom relief after starting PPI therapy. In this view, it is important to identify these patients who will react on treatment with PPI in quick, accurate, non-invasive and cheap manner. The Reflux Impact Scale (RIS) is validated, short, self explanatory questionnaire which asks for the presence & impact of reflux symptoms. The RIS is developed for PCP to aid in the evaluation & selection of these patient who will profit from treatment with PPI. The aim of this present study is to determine which questions of the RIS can be predictive for reaching treatment success with PPI. Treatment success is determined by asking for patients' satisfaction & completion of the McMaster Overall Treatment Evaluation Heartburn questionnaire.

Study Overview

• Status: Terminated
• Conditions: Gastroesophageal Reflux Disease; GERD; Heartburn; Acid Regurgitation; Retrosternal Pain

• Study Type: Observational
• Enrollment (Anticipated): 938

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at general practitioner

Description

Inclusion Criteria:

• Age 18 years or older
• Patients with symptoms of reflux disease and or regurgitation and/or retrosternal pain probably caused by acid during the previous 7 days and for which treatment with a PPI is started.

Exclusion Criteria:

• Use of PPI and/or H2-receptor antagonist in the month prior to participation in this study.
• Presence of alarm symptoms

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Chair: N van den Berk, AstraZeneca; Study Director: A Sellink, AstraZeneca

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: September 26, 2007
• First Submitted That Met QC Criteria: September 26, 2007
• First Posted (Estimate): September 27, 2007

Study Record Updates

• Last Update Posted (Estimate): July 9, 2008
• Last Update Submitted That Met QC Criteria: July 7, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: proton pump inhibitor; patient satisfaction; treatment success; predictive value; gastro-esophageal reflux disease; Reflux Impact Scale (RIS); PPU
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Heartburn
• Other Study ID Numbers: NL401611