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Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms

AIM: To evaluate the psychometric properties of a newly developed questionnaire, known as the gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test (GERD-TEST), in patients with GERD. METHODS: Japanese patients with predominant GERD symptoms recruited according to the Mont...

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Autores principales: Nakada, Koji, Matsuhashi, Nobuyuki, Iwakiri, Katsuhiko, Oshio, Atsushi, Joh, Takashi, Higuchi, Kazuhide, Haruma, Ken
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Baishideng Publishing Group Inc 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5537188/
https://www.ncbi.nlm.nih.gov/pubmed/28811716
http://dx.doi.org/10.3748/wjg.v23.i28.5216
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author Nakada, Koji
Matsuhashi, Nobuyuki
Iwakiri, Katsuhiko
Oshio, Atsushi
Joh, Takashi
Higuchi, Kazuhide
Haruma, Ken
author_facet Nakada, Koji
Matsuhashi, Nobuyuki
Iwakiri, Katsuhiko
Oshio, Atsushi
Joh, Takashi
Higuchi, Kazuhide
Haruma, Ken
author_sort Nakada, Koji
collection PubMed
description AIM: To evaluate the psychometric properties of a newly developed questionnaire, known as the gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test (GERD-TEST), in patients with GERD. METHODS: Japanese patients with predominant GERD symptoms recruited according to the Montreal definition were treated for 4 wk using a standard dose of proton pump inhibitor (PPI). The GERD-TEST and the Medical Outcome Study Short Form-8 Health Survey (SF-8) were administered at baseline and after 4 wk of treatment. The GERD-TEST contains three domains: the severity of GERD and functional dyspepsia (FD) symptoms (5 items), the level of dissatisfaction with daily life (DS) (4 items), and the therapeutic efficacy as assessed by the patients and medication compliance (4 items). RESULTS: A total of 290 patients were eligible at baseline; 198 of these patients completed 4 wk of PPI therapy. The internal consistency reliability as evaluated using the Cronbach’s α values for the GERD, FD and DS subscales ranged from 0.75 to 0.82. The scores for the GERD, FD and DS items/subscales were significantly correlated with the physical and mental component summary scores of the SF-8. After 4 wk of PPI treatment, the scores for the GERD items/subscales were greatly reduced, ranging in value from 1.51 to 1.87 and with a large effect size (P < 0.0001, Cohen’s d; 1.29-1.63). Statistically significant differences in the changes in the scores for the GERD items/subscales were observed between treatment responders and non-responders (P < 0.0001). CONCLUSION: The GERD-TEST has a good reliability, a good convergent and concurrent validity, and is responsive to the effects of treatment. The GERD-TEST is a simple, easy to understand, and multifaceted PRO instrument applicable to both clinical trials and the primary care of GERD patients.
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spelling pubmed-55371882017-08-15 Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms Nakada, Koji Matsuhashi, Nobuyuki Iwakiri, Katsuhiko Oshio, Atsushi Joh, Takashi Higuchi, Kazuhide Haruma, Ken World J Gastroenterol Observational Study AIM: To evaluate the psychometric properties of a newly developed questionnaire, known as the gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test (GERD-TEST), in patients with GERD. METHODS: Japanese patients with predominant GERD symptoms recruited according to the Montreal definition were treated for 4 wk using a standard dose of proton pump inhibitor (PPI). The GERD-TEST and the Medical Outcome Study Short Form-8 Health Survey (SF-8) were administered at baseline and after 4 wk of treatment. The GERD-TEST contains three domains: the severity of GERD and functional dyspepsia (FD) symptoms (5 items), the level of dissatisfaction with daily life (DS) (4 items), and the therapeutic efficacy as assessed by the patients and medication compliance (4 items). RESULTS: A total of 290 patients were eligible at baseline; 198 of these patients completed 4 wk of PPI therapy. The internal consistency reliability as evaluated using the Cronbach’s α values for the GERD, FD and DS subscales ranged from 0.75 to 0.82. The scores for the GERD, FD and DS items/subscales were significantly correlated with the physical and mental component summary scores of the SF-8. After 4 wk of PPI treatment, the scores for the GERD items/subscales were greatly reduced, ranging in value from 1.51 to 1.87 and with a large effect size (P < 0.0001, Cohen’s d; 1.29-1.63). Statistically significant differences in the changes in the scores for the GERD items/subscales were observed between treatment responders and non-responders (P < 0.0001). CONCLUSION: The GERD-TEST has a good reliability, a good convergent and concurrent validity, and is responsive to the effects of treatment. The GERD-TEST is a simple, easy to understand, and multifaceted PRO instrument applicable to both clinical trials and the primary care of GERD patients. Baishideng Publishing Group Inc 2017-07-28 2017-07-28 /pmc/articles/PMC5537188/ /pubmed/28811716 http://dx.doi.org/10.3748/wjg.v23.i28.5216 Text en ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved. http://creativecommons.org/licenses/by-nc/4.0/ This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.
spellingShingle Observational Study
Nakada, Koji
Matsuhashi, Nobuyuki
Iwakiri, Katsuhiko
Oshio, Atsushi
Joh, Takashi
Higuchi, Kazuhide
Haruma, Ken
Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms
title Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms
title_full Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms
title_fullStr Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms
title_full_unstemmed Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms
title_short Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms
title_sort development and validation of a simple and multifaceted instrument, gerd-test, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms
topic Observational Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5537188/
https://www.ncbi.nlm.nih.gov/pubmed/28811716
http://dx.doi.org/10.3748/wjg.v23.i28.5216
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