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      Development, Translation and Validation of Enhanced Asian Rome III Questionnaires for Diagnosis of Functional Bowel Diseases in Major Asian Languages: A Rome Foundation-Asian Neurogastroenterology and Motility Association Working Team Report

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          Abstract

          Background/Aims

          The development-processes by regional socio-cultural adaptation of an Enhanced Asian Rome III questionnaire (EAR3Q), a cultural adaptation of the Rome III diagnostic questionnaire (R3DQ), and its translation-validation in Asian languages are presented. As English is not the first language for most Asians, translation-validation of EAR3Q is essential. Hence, we aimed to culturally adapt the R3DQ to develop EAR3Q and linguistically validate it to show that the EAR3Q is able to allocate diagnosis according to Rome III criteria.

          Methods

          After EAR3Q was developed by Asian experts by consensus, it was translated into Chinese, Hindi-Telugu, Indonesian, Korean, and Thai, following Rome Foundation guidelines; these were then validated on native subjects (healthy [n = 60], and patients with irritable bowel syndrome [n = 59], functional dyspepsia [n = 53] and functional constipation [n = 61]) diagnosed by clinicians using Rome III criteria, negative alarm features and investigations.

          Results

          Experts noted words for constipation, bloating, fullness and heartburn, posed difficulty. The English back-translated questionnaires demonstrated concordance with the original EAR3Q. Sensitivity and specificity of the questionnaires were high enough to diagnose respective functional gastrointestinal disorders (gold standard: clinical diagnoses) in most except Korean and Indonesian languages. Questionnaires often uncovered overlapping functional gastrointestinal disorders. Test-retest agreement (kappa) values of the translated questionnaires were high (0.700–1.000) except in Korean (0.300–0.500) and Indonesian (0.100–0.400) languages at the initial and 2-week follow-up visit.

          Conclusions

          Though Chinese, Hindi and Telugu translations were performed well, Korean and Indonesian versions were not. Questionnaires often uncovered overlapping FGIDs, which were quite common.

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          Most cited references32

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          Translation and validation of study instruments for cross-cultural research.

          Cross-cultural research often involves physicians, nurses, and other health care providers. In studies of fecal and urinary incontinence, cross-cultural research has been applied to quality-of-life comparisons, and instruments have been translated to foreign languages for use in other countries. This report presents some of the principal methodological issues and problems associated with translating questionnaires for use in cross-cultural research in a manner relevant to clinicians and health care practitioners who are aware that, unless these potential problems are addressed, the results of their research may be suspect. Translation is the most common method of preparing instruments for cross-cultural research and has pitfalls that threaten validity. Some of these problems are difficult to detect and may have a detrimental effect on the study results. Identification and correction of problems can enhance research quality and validity. A method for translation and validation is presented in detail. However, the specific validation method adopted is less important than the recognition that the translation process must be appropriate and the validation process rigorous.
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            Prevalence of overlaps between GERD, FD and IBS and impact on health-related quality of life.

            Gastroesophageal reflux disease (GERD), functional dyspepsia (FD), and irritable bowel syndrome (IBS) are common, and have negative impacts on health-related quality of life (HR-QOL). Several studies demonstrated a significant overlap between two of these three diseases. The purpose of this study was to examine the prevalence of GERD, FD, and IBS, their overlap rates, and HR-QOL for each disease and each overlap compared with healthy controls in the Japanese general population. We performed a cross-sectional study of Japanese workers who visited a clinic for a routine health check-up, and asked them to fill out a self-report questionnaire. Prevalence and overlap rate of GERD defined as heartburn and/or acid regurgitation at least weekly, FD and IBS based on Rome III criteria, and HR-QOL by SF-8 were examined. Of the 2680 eligible subjects, 207 (7.7%) were diagnosed as having GERD, 269 (10.0%) as FD, and 381 (14.2%) as IBS. Overlaps were found in 46.9% in GERD, 47.6% in FD, and 34.4% in IBS. Prevalence of overlaps in subjects with IBS was significantly lower compared with those among GERD or FD. Sufferers from GERD, FD, or IBS reported significantly poorer HR-QOL across all domains compared with controls. Overlaps significantly worsened HR-QOL in most domains except in the 'role emotional' domain. HR-QOL was particularly poor in the physical component summary for overlapping GERD and in the mental component summary for overlapping IBS. Overlaps among GERD, FD and IBS were common and worsened HR-QOL in Japanese general population.
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              Epidemiology of Uninvestigated and Functional Dyspepsia in Asia: Facts and Fiction

              Dyspepsia is a syndrome consisting of epigastric pain, burning, fullness, discomfort, early satiety, nausea, vomiting and belching. Functional dyspepsia (FD) is diagnosed if upper gastrointestinal endoscopy does not show structural abnormality explaining these symptoms. 8%-30% and 8%-23% of Asian people suffer from of uninvestigated dyspepsia and FD, respectively. Most patients with uninvestigated dyspepsia are found to have FD. Patients with FD are usually young and there is no predilection to any gender. Overlap of FD with other functional bowel diseases such as irritable bowel syndrome and gastroesophageal reflux disease is common in Asia. Cultural difference in reporting of symptoms of dyspepsia is well-known. Moreover, dietary factors, socio-cultural and psychological issues, gastrointestinal infection including that caused by Helicobacter pylori, frequency of organic diseases such as peptic ulcer and gastric cancer responsible for dyspeptic symptoms in the study population may also influence epidemiology of dyspepsia. There is considerable heterogeneity in the above issues among different Asian countries. More studies on epidemiology of FD are needed in Asia.
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                Author and article information

                Journal
                J Neurogastroenterol Motil
                J Neurogastroenterol Motil
                Journal of Neurogastroenterology and Motility
                Korean Society of Neurogastroenterology and Motility
                2093-0879
                2093-0887
                January 2015
                : 21
                : 1
                : 83-92
                Affiliations
                [1 ]Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India;
                [2 ]Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore;
                [3 ]Department of Gastroenterology and Hepatology, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China;
                [4 ]Asian Institute of Gastroenterology, Hyderabad, India;
                [5 ]Department of Gastroenterology and Hepatology, Union Hospital of Tongji Medical College, Huazhong University of Science and Techonology, Wuhan, Hubei, China;
                [6 ]Division of Gastroenterology, Department of Internal Medicine, Cipto Mangunkusumo General Hospital/Faculty of Medicine, University of Indonesia, Jakarta, Indonesia;
                [7 ]Department of Gastroenterology, Korea University Guro Hospital, Seoul, South Korea;
                [8 ]Division of Gastroenterology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea;
                [9 ]GI Motility Research Unit, Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand;
                [10 ]Gastro Centre Ipoh, Ipoh, Perak, Malaysia;
                [11 ]Klinic Chong, Slim River, Perak, Malaysia;
                [12 ]Division of Gastroenterology & Hepatology, University Medicine Cluster, National University Hospital, Singapore;
                [13 ]Division of Gastroenterology, Taipei Veterans General Hospital, National Yang-Ming University Taipei, Taiwan
                [14 ]Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
                Author notes

                Author contributions: Uday C Ghoshal, study conceptualisation, planning, supervision, data analysis, and manuscript writing; Kok-Ann Gwe, study conceptualisation, planning, and manuscript writing; Sutep Gonlachanvit, Minhu Chen, Nitesh Pratap, Xiao R Gong, Xiaohua Hou, Ari F Syam, Murdani Abdullah, Young-Tae Bak, Myung-Gyu Choi, Andrew S B Chua, Kuck-Meng Chong, Kewin T H Siah, Ching-Liang Lu and Lishou Xiong, planning, supervision, data analysis, and manuscript review; William E Whitehead, study conceptualization, and planning of the manuscript.

                [* ]Correspondence: Kok-Ann Gwee, FRCP, PhD, Stomach, Liver and Bowel Center, Gleneagles Hospital, Annexe Block 05-37, 6A Napier Road, Singapore 258500, Singapore, Tel: +65-6474-6848, Fax: +65-6475-8285, E-mail: slbclinic@ 123456gmail.com
                Article
                jnm-21-83
                10.5056/jnm14045
                4288097
                25537673
                a17340a6-752f-418e-8f63-77cc25cd62eb
                © 2015 The Korean Society of Neurogastroenterology and Motility

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 10 April 2014
                : 06 October 2014
                : 08 October 2014
                Categories
                Original Article

                Neurology
                asia,gastrointestinal diseases,rome iii criteria,translations,validation
                Neurology
                asia, gastrointestinal diseases, rome iii criteria, translations, validation

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