Psychometric validation of the Dutch translation of the quality of life in reflux and dyspepsia (QOLRAD) questionnaire i
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RESEARCH
Open Access
Psychometric validation of the Dutch translation of the quality of life in reflux and dyspepsia (QOLRAD) questionnaire in patients with gastroesophageal reflux disease Leopold GJB Engels1, Elly C Klinkenberg-Knol2, Jonas Carlsson3, Katarina Halling3,4,5*
Abstract Background: The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire is one of the best-characterized disease-specific instruments that captures health-related problems and symptom-patterns in patients with gastroesophageal reflux disease (GERD). This paper reports the psychometric validation of a Dutch translation of the QOLRAD questionnaire in gastroenterology outpatients with GERD. Methods: Patients completed the QOLRAD questionnaire at visit 1 (baseline), visit 2 (after 2, 4 or 8 weeks of acute treatment with esomeprazole 40 mg once daily), and visit 4 (after 6 months with on-demand esomeprazole 40 mg once daily or continuous esomeprazole 20 mg once daily). Symptoms were assessed at each visit, and patient satisfaction was assessed at visits 2 and 4. Results: Of the 1166 patients entered in the study, 97.3% had moderate or severe heartburn and 55.5% had moderate or severe regurgitation at baseline. At visit 2, symptoms of heartburn and regurgitation were mild or absent in 96.7% and 97.7%, respectively, and 95.3% of patients reported being satisfied with the treatment. The internal consistency and reliability of the QOLRAD questionnaire (range: 0.83-0.92) supported construct validity. Convergent validity was moderate to low. Known-groups validity was confirmed by a negative correlation between the QOLRAD score and clinician-assessed severity of GERD symptoms. Effect sizes (1.15-1.93) and standardized response means (1.17-1.86) showed good responsiveness to change. GERD symptoms had a negative impact on patients’ lives. Conclusions: The psychometric characteristics of the Dutch translation of the QOLRAD questionnaire were found to be satisfactory, with good reliability and responsiveness to change, although convergent validity was at best moderate.
Background Gastroesophageal reflux disease (GERD) is a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications [1]. The characteristic symptoms of GERD are heartburn and regurgitation, which have a prevalence of 75-98% and 48-91%, respectively, in patients with reflux disease [1]. Dysphagia is also common, especially in individuals with reflux esophagitis [2]. GERD affects many aspects * Correspondence: [email protected] 3 Outcomes Research, AstraZeneca R&D, 431 83 Mölndal, Sweden Full list of author information is available at the end of the article
of day-to-day functioning, including sleep, productivity at work and at home, and enjoyment of meals and social occasions [3-5]. Symptoms can also cause emotional distress. Assessing the impact of reflux symptoms on patients’ lives can provide important information on health status and perceived treatment efficacy. Such assessment should be carried out using validat
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