Background/AimsReliable 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.
MethodsThe 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. Olafur Palsson. Professor Fukudo received a research grant from Kao and Astellas. He also received lecture fees from Abbott Japan, Dainippon-Sumitomo, and Astellas. Professor Drossman is a President of the Rome Foundation that created the Rome III criteria and he receives a stipend for this work. He also receives royalties for publication of the Rome III book. Professors Whitehead and Palsson received research grants from Ironwood Pharmaceuticals, Takeda Pharmaceuticals, and Salix Pharmaceuticals. Professor Whitehead is a consultant to Ono Pharma USA. Author contributions: Motoyori Kanazawa participated in study design, data collection, data analysis, and preparation of the manuscript; Shigemi Nakajima participated in data collection; Tadayuki Oshima participated in data collection; William E Whitehead participated in study design and preparation of the manuscript; Ami D Sperber, Olafur S Palsson and Douglas A Drossman participated in preparation of the manuscript; Hiroto Miwa participated in study design and data collection; and Shin Fukudo participated as the guarantor of this paper, and he participated in study design, data collection, data analysis, and manuscript preparation. ORCID: Motoyori Kanazawa, http://orcid.org/0000-0003-1953-3336.
Motoyori Kanazawa, et al
Journal of Neurogastroenterology and Motility
538
ResultsMedian 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).
ConclusionsThe 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. (J Neurogastroenterol Motil 2015;21:5...