BACKGROUND: A comprehensive assessment instrument that measures the burden of both symptoms and treatment is needed to determine the optimal management of gastroesophageal reflux disease (GERD), and we developed such an instrument. METHODS: This validation study included 3 groups: patients with active GERD (n = 193), surgical patients with prior GERD (n = 197), and general medical outpatients (n = 63). All completed an initial survey. General medical patients and patients with active GERD were resurveyed after 2 to 6 weeks. The main outcome measures were test-retest reliability, internal consistency, discriminant validity, and responsiveness to change for 3 scales graduated from 0 to 100: a GERD burden (or overall impact on quality of life scale), a symptoms scale, and a treatment scale. Higher scores indicated greater disease burden. RESULTS: The GERD burden, symptoms, and treatment scales all demonstrated good discriminant validity, as patients in the active-GERD group had the highest scores. Scores on each scale effectively classified the patients who belonged to the active-GERD group. Moreover, scores improved substantially 8 weeks after surgery, thereby demonstrating the scales' responsiveness to change. As hypothesized, the burden of treatment was distinct from that of symptoms, as 23% of patients not bothered by GERD symptoms described their GERD treatment to be a moderate or serious problem. Indeed, the impact of treatment problems approached that of symptoms problems. All pairwise comparisons were significant (P<.02). CONCLUSIONS: The GERD burden, symptoms, and treatment scales were valid, reliable, and responsive instruments for use in patients with GERD. Our analyses highlight the importance of assessing both symptoms and treatment burden in patients with GERD.
BACKGROUND: A comprehensive assessment instrument that measures the burden of both symptoms and treatment is needed to determine the optimal management of gastroesophageal reflux disease (GERD), and we developed such an instrument. METHODS: This validation study included 3 groups: patients with active GERD (n = 193), surgical patients with prior GERD (n = 197), and general medical outpatients (n = 63). All completed an initial survey. General medical patients and patients with active GERD were resurveyed after 2 to 6 weeks. The main outcome measures were test-retest reliability, internal consistency, discriminant validity, and responsiveness to change for 3 scales graduated from 0 to 100: a GERD burden (or overall impact on quality of life scale), a symptoms scale, and a treatment scale. Higher scores indicated greater disease burden. RESULTS: The GERD burden, symptoms, and treatment scales all demonstrated good discriminant validity, as patients in the active-GERD group had the highest scores. Scores on each scale effectively classified the patients who belonged to the active-GERD group. Moreover, scores improved substantially 8 weeks after surgery, thereby demonstrating the scales' responsiveness to change. As hypothesized, the burden of treatment was distinct from that of symptoms, as 23% of patients not bothered by GERD symptoms described their GERD treatment to be a moderate or serious problem. Indeed, the impact of treatment problems approached that of symptoms problems. All pairwise comparisons were significant (P<.02). CONCLUSIONS: The GERD burden, symptoms, and treatment scales were valid, reliable, and responsive instruments for use in patients with GERD. Our analyses highlight the importance of assessing both symptoms and treatment burden in patients with GERD.
Authors: Puja Khanna; Nikhil Agarwal; Dinesh Khanna; Ron D Hays; Lin Chang; Roger Bolus; Gil Melmed; Cynthia B Whitman; Robert M Kaplan; Rikke Ogawa; Bradley Snyder; Brennan Mr Spiegel Journal: Am J Gastroenterol Date: 2013-12-17 Impact factor: 10.864
Authors: Allison R Wilcox; Maria Concepcion C Dragnev; Christopher J Darcey; Corey A Siegel Journal: Inflamm Bowel Dis Date: 2010-04 Impact factor: 5.325
Authors: Viet-Thi Tran; Victor M Montori; David T Eton; Dan Baruch; Bruno Falissard; Philippe Ravaud Journal: BMC Med Date: 2012-07-04 Impact factor: 8.775
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Authors: David T Eton; Jennifer L Ridgeway; Jason S Egginton; Kristina Tiedje; Mark Linzer; Deborah H Boehm; Sara Poplau; Djenane Ramalho de Oliveira; Laura Odell; Victor M Montori; Carl R May; Roger T Anderson Journal: Patient Relat Outcome Meas Date: 2015-03-27