Look--but also listen! ReQuest: A new dimension-oriented GERD symptom scale.

Area of Science:

• Gastroenterology
• Clinical Therapeutics
• Patient-Reported Outcomes

Background:

• Gastroesophageal reflux disease (GERD) presents a broad symptom spectrum, often with negative endoscopic findings.
• Endoscopy's utility in assessing GERD treatment response is limited, increasing the importance of symptom-based evaluations.
• Novel outcome measures are needed for accurate GERD symptom assessment.

Purpose of the Study:

• To introduce and validate the Reflux Questionnaire (ReQuest) as a tool for tracking and quantifying GERD symptoms.
• To establish ReQuest as a reliable and robust method for assessing treatment efficacy in GERD patients.
• To provide a validated instrument meeting regulatory criteria for primary outcome measure in clinical trials.

Main Methods:

• Development of the Reflux Questionnaire (ReQuest) with seven dimensions measuring symptom frequency and intensity.
• Inclusion of a short version (frequency/intensity) and a long version (67 symptom descriptions).
• Rigorous validation including clinical trial evaluation, statistical analysis, internal consistency, reliability, construct validity, and responsiveness assessment.

Main Results:

• The Reflux Questionnaire (ReQuest) demonstrated strong performance across key psychometric measures.
• Internal consistency, test/retest reliability, construct validity, and responsiveness to treatment changes met or exceeded requirements.
• The validation process confirmed the accuracy and robustness of the ReQuest instrument.

Conclusions:

• The Reflux Questionnaire (ReQuest) is a brief, effective, and validated instrument for quantifying GERD symptoms.
• ReQuest meets regulatory criteria and is suitable as a primary outcome measure for GERD clinical trials.
• This tool will aid in tracking symptom burden and assessing treatment effectiveness for GERD.