Validity and Reliability of the Japanese Version of the Rome III Diagnostic Questionnaire for Irritable Bowel Syndrome and Functional Dyspepsia.
OBJECTIVE
Reliable diagnostic instruments for measuring the presence of functional gastrointestinal disorders based on the Rome III criteria have been lacking in Japan. The aims of the present study were to translate and validate the Rome III diagnostic questionnaire which was widely used in Western countries.


METHODS
The original version of Rome III diagnostic questionnaire was translated from English into Japanese through 3 independent forward translations, resolution, back translation and reconciliation of the differences. Forty-nine patients with irritable bowel syndrome (IBS), 32 patients with functional dyspepsia (FD) and 56 subjects without any current GI symptoms as controls were recruited from three hospitals located in different regions of Japan and completed the IBS and FD diagnostic modules twice within 14 days. Kappa statistic was used to assess test-retest reliability. The sensitivity and specificity of each diagnostic module for distinguishing IBS or FD patients from controls was tested.


RESULTS
Median kappa statistics were 0.63 for the translated IBS diagnostic module and 0.68 for the FD module. The sensitivity, specificity, and positive predict value of the IBS module against physician diagnosis was 61.2%, 100%, and 100% and those of the FD module was 53.2%, 98.2%, and 94.4%, respectively. Meanwhile, IBS patients were significantly more likely to report blood in stools compared to controls (18.4% vs 1.8%, P < 0.01).


CONCLUSIONS
The IBS and FD diagnostic modules on the Japanese version of the Rome III diagnostic questionnaire are valid and reliable. Further studies are warranted to elucidate the diagnostic utility of the red flag questionnaire.
Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Motoyori
http://orcid.org/0000-0003-1953-3336
M
Kanazawa
Department of Medicine, Gastroenterology and Health Care, Japan Community Health care Organization Shiga Hospital, Otsu, Shiga, Japan.
Shigemi
S
Nakajima
Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
Tadayuki
T
Oshima
Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
William E
WE
Whitehead
Department of Gastroenterology, Tel Aviv Medical Center, Levahim, Israel.
Ami D
AD
Sperber
Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Olafur S
OS
Palsson
Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Douglas A
DA
Drossman
Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
Hiroto
H
Miwa
Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Shin
S
Fukudo
Dyspepsia; Functional gastrointestinal disorders; Irritable bowel syndrome; Japan; Questionnaire; Translations