Abstract
BackgroundSymptoms of dyspepsia significantly disrupt patients' lives and reliable methods of assessing symptom status are important for patient management. The aim of the current study was to document the psychometric characteristics of the Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) in Afrikaans, German, Hungarian, Italian, Polish and Spanish patients with dyspepsia.Methods853 patients with symptoms of dyspepsia completed the GSRS, the QOLRAD, the 36-item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression scale.ResultsThe internal consistency reliability of the GSRS was 0.43–0.87 and of the QOLRAD 0.79–0.95. Test-retest reliability of the GSRS was 0.36–0.75 and of the QOLRAD 0.41–0.82. GSRS Abdominal pain domain correlated significantly with all QOLRAD domains in most language versions, and with SF-36 Bodily pain in all versions. QOLRAD domains correlated significantly with the majority of SF-36 domains in most versions. Both questionnaires were able to differentiate between patients whose health status differed according to symptom frequency and severity.ConclusionThe psychometric characteristics of the different language versions of the GSRS and QOLRAD were found to be good, with acceptable reliability and validity. The GSRS and QOLRAD were found to be useful for evaluating dyspeptic symptoms and their impact on patients' daily lives in multinational clinical trials.
Highlights
Symptoms of dyspepsia significantly disrupt patients' lives and reliable methods of assessing symptom status are important for patient management
This report aims to document the psychometric characteristics of two patient-reported outcomes (PRO) instruments, the Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), in patients with dyspepsia
The GSRS and the QOLRAD are two of the most established, validated, reliable and responsive disease-specific instruments available for assessing gastrointestinal symptoms and their impact on patients' daily functioning [37,39]. Both questionnaires have been proven to have very good psychometric characteristics when tested in clinical trials in patients with GERD and dyspepsia [20,56,57]
Summary
Symptoms of dyspepsia significantly disrupt patients' lives and reliable methods of assessing symptom status are important for patient management. At the Rome II consensus conference held in 1999, the recommended definition of dyspepsia was 'pain or discomfort centred in the upper abdomen' [1,2]. Symptoms such as heartburn, nausea, post-prandial fullness, early satiety or bloating may be present [3,4,5,6,7]. The US Food and Drug Administration (FDA) has recently issued a draft guidance on PRO measures [28] In line with these guidelines, instruments need to show reliability, validity and an ability to detect change
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