Observational Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 28, 2017; 23(28): 5216-5228
Published online Jul 28, 2017. doi: 10.3748/wjg.v23.i28.5216
Development and validation of a simple and multifaceted instrument, GERD-TEST, for the clinical evaluation of gastroesophageal reflux and dyspeptic symptoms
Koji Nakada, Nobuyuki Matsuhashi, Katsuhiko Iwakiri, Atsushi Oshio, Takashi Joh, Kazuhide Higuchi, Ken Haruma
Koji Nakada, Department of Laboratory Medicine, Daisan Hospital Jikei University School of Medicine, Tokyo 201-8601, Japan
Nobuyuki Matsuhashi, Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo 141-8625, Japan
Katsuhiko Iwakiri, Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo 113-0022, Japan
Atsushi Oshio, Faculty of Letters, Arts and Sciences, Waseda University, Tokyo 162-8644, Japan
Takashi Joh, Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya 467-8601, Japan
Kazuhide Higuchi, Second Department of Internal Medicine, Osaka Medical College, Osaka 569-8686, Japan
Ken Haruma, Department of General Internal Medicine 2, Kawasaki Medical School Kawasaki Hospital, Kurashiki 701-0192, Japan
Author contributions: Nakada K, Iwakiri K, Joh T, Higuchi K and Haruma K designed the study; Matsuhashi N and other physicians listed in the acknowledgments collected the data; Oshio A contributed to statistical analysis; Nakada K wrote the paper; all authors have read and approved the final version to be published.
Supported by Financial support for this clinical study was provided by GERD Society (Osaka, Japan).
Institutional review board statement: This study was approval by the ethics committee of each institution or the central ethics committee of Nishi Clinic, Osaka, Japan.
Informed consent statement: Written informed consent was obtained from all enrolled patients.
Clinical trial registration statement: This study was registered with the University Hospital Medical Information Network’s Clinical Trials Registry (UMIN-CTR; registration number 000006614).
Conflict-of-interest statement: The authors declare no conflicts of interests related to the publication of this study.
Data sharing statement: No additional data was available.
Open-Access: 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. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Koji Nakada, MD, PhD, Associate Professor, Department of Laboratory Medicine, Daisan Hospital Jikei University School of Medicine, 4-11-1, Izumihoncyo, Komae-shi, Tokyo 201-8601, Japan. nakada@jikei.ac.jp
Telephone: +81-3-34801151-3401 Fax: +81-3-34805700
Received: March 6, 2017
Peer-review started: March 7, 2017
First decision: April 25, 2017
Revised: June 11, 2017
Accepted: June 19, 2017
Article in press: June 19, 2017
Published online: July 28, 2017
Processing time: 143 Days and 10.2 Hours
Abstract
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.

Keywords: Gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test; Patient-reported outcome; Gastroesophageal reflux disease; Validity; Reliability

Core tip: A patient-reported outcome (PRO) can be a clinically relevant outcome measure of disease impact and treatment response in both clinical trials and primary care. The practical use and dissemination of PRO as a diagnostic and evaluation tool is anticipated; however, most PROs are lengthy and complicated. Therefore, we developed a simple, easy-to-understand and multifaceted PRO instrument, the gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test (GERD-TEST). The psychometric characteristics of the GERD-TEST were excellent, demonstrating good validity and reliability. The GERD-TEST enabled a multifaceted evaluation not only of the severity of symptoms, but also of the impact of the symptoms on daily life, the therapeutic response as assessed by the patient. The GERD-TEST is expected to be a useful diagnostic/treatment tool for both clinical research and in daily clinical practice settings.