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The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials

Shaw, Michael; Dent, John; Beebe, Timothy; Junghard, Ola; Wiklund, Ingela; Lind, Tore and Johnsson, Folke LU (2008) In Health and Quality of Life Outcomes 6(31).
Abstract
Background: Critical needs for treatment trials in gastroesophageal reflux disease (GERD) include assessing response to treatment, evaluating symptom severity, and translation of symptom questionnaires into multiple languages. We evaluated the previously validated Reflux Disease Questionnaire (RDQ) for internal consistency, reliability, responsiveness to change during treatment and the concordance between RDQ and specialty physician assessment of symptom severity, after translation into Swedish and Norwegian. Methods: Performance of the RDQ after translation into Swedish and Norwegian was evaluated in 439 patients with presumed GERD in a randomized, double-blind trial of active treatment with a proton pump inhibitor. Results: The... (More)
Background: Critical needs for treatment trials in gastroesophageal reflux disease (GERD) include assessing response to treatment, evaluating symptom severity, and translation of symptom questionnaires into multiple languages. We evaluated the previously validated Reflux Disease Questionnaire (RDQ) for internal consistency, reliability, responsiveness to change during treatment and the concordance between RDQ and specialty physician assessment of symptom severity, after translation into Swedish and Norwegian. Methods: Performance of the RDQ after translation into Swedish and Norwegian was evaluated in 439 patients with presumed GERD in a randomized, double-blind trial of active treatment with a proton pump inhibitor. Results: The responsiveness was excellent across three RDQ indicators. Mean change scores in patients on active treatment were large, also reflected in effect sizes that ranged from a low of 1.05 (dyspepsia) to a high of 2.05 (heartburn) and standardized response means 0.99 (dyspepsia) and 1.52 (heartburn). A good positive correlation between physician severity ratings and RDQ scale scores was seen. The internal consistency reliability using alpha coefficients of the scales, regardless of language, ranged from 0.67 to 0.89. Conclusion: The results provide strong evidence that the RDQ is amenable to translation and represents a viable instrument for assessing response to treatment, and symptom severity. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Health and Quality of Life Outcomes
volume
6
issue
31
publisher
BioMed Central
external identifiers
  • wos:000256210400001
  • scopus:44249104937
ISSN
1477-7525
DOI
10.1186/1477-7525-6-31
language
English
LU publication?
yes
id
f009447e-3616-4ebd-b8a2-2e2d63728b84 (old id 1202042)
date added to LUP
2008-09-15 14:04:11
date last changed
2017-08-06 04:17:27
@article{f009447e-3616-4ebd-b8a2-2e2d63728b84,
  abstract     = {Background: Critical needs for treatment trials in gastroesophageal reflux disease (GERD) include assessing response to treatment, evaluating symptom severity, and translation of symptom questionnaires into multiple languages. We evaluated the previously validated Reflux Disease Questionnaire (RDQ) for internal consistency, reliability, responsiveness to change during treatment and the concordance between RDQ and specialty physician assessment of symptom severity, after translation into Swedish and Norwegian. Methods: Performance of the RDQ after translation into Swedish and Norwegian was evaluated in 439 patients with presumed GERD in a randomized, double-blind trial of active treatment with a proton pump inhibitor. Results: The responsiveness was excellent across three RDQ indicators. Mean change scores in patients on active treatment were large, also reflected in effect sizes that ranged from a low of 1.05 (dyspepsia) to a high of 2.05 (heartburn) and standardized response means 0.99 (dyspepsia) and 1.52 (heartburn). A good positive correlation between physician severity ratings and RDQ scale scores was seen. The internal consistency reliability using alpha coefficients of the scales, regardless of language, ranged from 0.67 to 0.89. Conclusion: The results provide strong evidence that the RDQ is amenable to translation and represents a viable instrument for assessing response to treatment, and symptom severity.},
  articleno    = {6 pp},
  author       = {Shaw, Michael and Dent, John and Beebe, Timothy and Junghard, Ola and Wiklund, Ingela and Lind, Tore and Johnsson, Folke},
  issn         = {1477-7525},
  language     = {eng},
  number       = {31},
  publisher    = {BioMed Central},
  series       = {Health and Quality of Life Outcomes},
  title        = {The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials},
  url          = {http://dx.doi.org/10.1186/1477-7525-6-31},
  volume       = {6},
  year         = {2008},
}