Measuring symptom distress and health-related quality of life in clinical trials of gastroesophageal reflux disease treatment: further validation of the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) |
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Authors: | Damiano Anne Handley Kathleen Adler Ellen Siddique Reshmi Bhattacharyja Ashoke |
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Affiliation: | (1) Covance Health Economics and Outcomes Services Inc., Gaithersburg, Maryland, USA;(2) Janssen Pharmaceutica, Inc., Titusville, New Jersey, USA |
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Abstract: | This study reports the reliability and validity of the distress subscale of the GERD Symptom Assessment Scale (GSAS) and the acute SF-36 Health Survey in a clinical trial setting. Patients with moderately severe GERD completed the GSAS and SF-36 at baseline and four weeks following treatment. The age (mean ± sd) of the 187 patients was 45.5 ± 11.1 years and most were female (63%) and Caucasian (78%). All scales met the 0.70 reliability criterion except for the SF-36 bodily pain scale. Mean baseline GSAS scores were significantly (P < 0.001) poorer by 10–17% among patients reporting more severe levels of all symptoms. Mean baseline SF-36 physical component summary scores were significantly (P < 0.02) poorer among patients reporting more severe levels of regurgitation, early satiety, bloating, and nausea. Patients reporting complete and satisfactory heartburn relief reported improvements in GSAS scores that were 13% and 10% greater, respectively, than patients who did not experience these levels of relief (P < 0.001). In conclusion, the GSAS and SF-36 scales were reliable and valid measures in this clinical trial. Differences of 10% in GSAS distress scores correspond to differences in symptom severity at a point in time and to changes in symptom severity over time. The SF-36 was not as useful in detecting differences in symptom severity over time. |
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Keywords: | gastroesophageal reflux disease health-related quality of life symptom distress SF-36 Health Survey |
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