Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features, and Rome IV

Functional gastrointestinal disorders (FGIDs), the most common diagnoses in gastroenterology are recognized by morphological and physiological abnormalities that often occur in combination including motility disturbance, visceral hypersensitivity, altered mucosal and immune function, altered gut microbiota and altered central nervous system processing. Research on these gut-brain interaction disorders is based on using specific diagnostic criteria. The Rome Foundation has played a pivotal role in creating diagnostic criteria thus operationalizing the dissemination of new knowledge in the field of FGIDs. Rome IV is a compendium of the knowledge accumulated since Rome III was published 10 years ago. It improves upon Rome III by: 1) updating the basic and clinical literature, 2) offering new information on gut microenvironment, gut-brain interactions, pharmacogenomics, biopsychosocial, gender and cross cultural understandings of FGIDs, 3) reduces the use of imprecise and occassionally stigmatizing terms when possible, 4) uses updated diagnostic algorithms, 5) incorporates information on the patient illness experience, and physiological subgroups or biomarkers that might lead to more targeted treatment. This introductory article sets the stage for the remaining 17 articles that follow and offers an historical overview of the FGIDs field, differentiates FGIDs from motility and structural disorders, discusses the changes from Rome III, reviews the Rome committee process, provides a biopsychosocial pathophysiological conceptualization of FGIDs, and offers an approach to patient care

What Is New in Rome IV

Functional gastrointestinal disorders (FGIDs) are diagnosed and classified using the Rome criteria; the criteria may change over time as new scientific data emerge. The Rome IV was released in May 2016. The aim is to review the main changes in Rome IV. FGIDs are now called disorders of gut-brain interaction (DGBI). Rome IV has a multicultural rather than a Western-culture focus. There are new chapters including multicultural, age-gender-women’s health, intestinal microenvironment, biopsychosocial, and centrally mediated disorders. New disorders have been included although not truly FGIDs, but fit the new definition of DGBI including opioid-induced gastrointestinal hyperalgesia, opioid-induced constipation, and cannabinoid hyperemesis. Also, new FGIDs based on available evidence including reflux hypersensitivity and centrally mediated abdominal pain syndrome. Using a normative survey to determine the frequency of normal bowel symptoms in the general population changes in the time frame for diagnosis were introduced. For irritable bowel syndrome (IBS) only pain is required and discomfort was eliminated because it is non-specific, having different meanings in different languages. Pain is now related to bowel movements rather than just improving with bowel movements (ie, can get worse with bowel movement). Functional bowel disorders (functional diarrhea, functional constipation, IBS with predominant diarrhea [IBS-D], IBS with predominant constipation [IBS-C], and IBS with mixed bowel habits) are considered to be on a continuum rather than as independent entities. Clinical applications such as diagnostic algorithms and the Multidimensional Clinical Profile have been updated. The new Rome IV iteration is evidence-based, multicultural oriented and with clinical applications. As new evidence become available, future updates are expected

Biopsychosocial Model of Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a common chronic disorder seen in gastroenterology and primary care practice. It is characterized by recurrent abdominal pain or discomfort associated with disturbed bowel function. It is a heterogeneous disorder with varying treatments, and in this regard physicians sometimes struggle with finding the optimal approach to management of patients with IBS. This disorder induces high health care costs and variably reduces health-related quality of life. IBS is in the class of functional gastrointestinal disorders, and results from dysregulation of central and enteric nervous system interactions. Psychosocial factors are closely related to their gut physiology, associated cognitions, symptom manifestations and illness behavior. Therefore, it is important for the physician to recognize the psychosocial issues of patients with IBS and in addition to build a good patient-physician relationship in order to optimize treatment. This review focuses on the interaction between psychological and physiological factors associated with IBS by using a biopsychosocial model. In this article, we describe (1) the predisposing psychological features seen in early life; (2) the psychological factors associated with life stress, the symptom presentation, and their associated coping patterns; (3) gut pathophysiology with emphasis on disturbances in motility, visceral hypersensitivity and brain-gut interactions; and finally (4) the clinical outcomes and effective treatments including psychotherapeutic methods

Validation of Symptom-Based Diagnostic Criteria for Irritable Bowel Syndrome: A Critical Review

Critically review the validity of symptom-based criteria (Manning, Rome I, Rome II, and Rome III) for irritable bowel syndrome (IBS)

Evaluation of the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire in diarrheal-predominant irritable bowel syndrome patients

Background Diarrhea-predominant irritable bowel syndrome (IBS-d) significantly diminishes the health-related quality of life (HRQOL) of patients. Psychological and social impacts are common with many IBS-d patients reporting comorbid depression, anxiety, decreased intimacy, and lost working days. The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire is a 34-item instrument developed and validated for measurement of HRQOL in non-subtyped IBS patients. The current paper assesses this previously-validated instrument employing data collected from 754 patients who participated in a randomized clinical trial of a novel treatment, eluxadoline, for IBS-d. Methods Psychometric methods common to HRQOL research were employed to evaluate the IBS-QOL. Many of the historical analyses of the IBS-QOL validations were used. Other techniques that extended the original methods were applied where more appropriate for the current dataset. In IBS-d patients, we analyzed the items and substructure of the IBS-QOL via item reduction, factor structure, internal consistency, reproducibility, construct validity, and ability to detect change. Results This study supports the IBS-QOL as a psychometrically valid measure. Factor analyses suggested that IBS-specific QOL as measured by the IBS-QOL is a unidimensional construct. Construct validity was further buttressed by significant correlations between IBS-QOL total scores and related measures of IBS-d severity including the historically-relevant Irritable Bowel Syndrome Adequate Relief (IBS-AR) item and the FDA’s Clinical Responder definition. The IBS-QOL also showed a significant ability to detect change as evidenced by analysis of treatment effects. A minority of the items, unrelated to the IBS-d, performed less well by the standards set by the original authors. Conclusions We established that the IBS-QOL total score is a psychometrically valid measure of HRQOL in IBS-d patients enrolled in this study. Our analyses suggest that the IBS-QOL items demonstrate very good construct validity and ability to detect changes due to treatment effects. Furthermore, our analyses suggest that the IBS-QOL items measure a univariate construct and we believe further modeling of the IBS-QOL from an item response theory (IRT) approach under both non-treatment and treatment conditions would greatly further our understanding as item-based methods could be used to develop a short form

Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders

BACKGROUND: Lubiprostone is a ClC-2 chloride channel activator approved for the treatment of chronic idiopathic constipation (CIC) and opioid-induced constipation (OIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women. Lubiprostone is generally well tolerated, with nausea being the most common adverse event. AIMS: To characterize nausea with lubiprostone using pooled results from clinical studies in patients with CIC, OIC, or IBS-C. METHODS: Data from three 3- and 4-week placebo-controlled studies and three long-term open-label studies were pooled for the CIC analysis. The OIC and IBS-C analyses each used pooled data from three 12-week placebo-controlled studies and one 36-week open-label extension study. RESULTS: The populations included the following numbers of patients: CIC, 316 (placebo) and 1113 (lubiprostone 24 mcg twice daily [BID]); OIC, 652 (placebo) and 889 (lubiprostone 24 mcg BID); and IBS-C, 435 (placebo) and 1011 (lubiprostone 8 mcg BID). The incidence of nausea in lubiprostone-treated patients ranged from 11.4 to 31.1%, with the highest incidence in patients with CIC. Among patients with any nausea, most reported only mild or moderate severity (96.5-99.1% across indications) and only one event (83.6-88.7%); most events occurred within the first 5 days of treatment. CONCLUSIONS: Nausea was the most common adverse event following the treatment with lubiprostone. Event rates varied by indication and dose, and the majority of nausea adverse events were mild to moderate in severity. Nausea events predominantly occurred early in the treatment period in all of the pooled study populations

A Randomized Comparison of Alternative Formats for Clinical Simulations

Computer-based clinical simulations for medical education vary widely in structure and for mat, yet few studies have examined which formats are optimal for particular educational settings. This study is a randomized comparison of the same simulated case in three formats: a "pedagogic" format offering explicit educational support, a "high-fidelity" format attempting to model clinical reasoning in the real world, and a "problem-solving" format that requires students to express specific diagnostic hypotheses Data were collected from rising third- year medical students using a posttest, attitudinal questionnaire, students' writeups of the case, and log files of students' progress through the simulation. Student performances on all measures differed significantly by format. In general, students using the pedagogic format were more proficient but less efficient. They acquired more information but were able to do proportionately less with it. The results suggest that the format of computer-based simulations is an important educational variable. Key words. medical education, undergraduate; clinical reasoning; computer-assisted instruction. (Med Decis Making 1991;11:265-272

Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study

DGBI; IBS; EpidemiologyDGBI; IBS; EpidemiologiaDGBI; IBS; EpidemiologíaBackground & Aims Although functional gastrointestinal disorders (FGIDs), now called disorders of gut-brain interaction, have major economic effects on health care systems and adversely affect quality of life, little is known about their global prevalence and distribution. We investigated the prevalence of and factors associated with 22 FGIDs, in 33 countries on 6 continents. Methods Data were collected via the Internet in 24 countries, personal interviews in 7 countries, and both in 2 countries, using the Rome IV diagnostic questionnaire, Rome III irritable bowel syndrome questions, and 80 items to identify variables associated with FGIDs. Data collection methods differed for Internet and household groups, so data analyses were conducted and reported separately. Results Among the 73,076 adult respondents (49.5% women), diagnostic criteria were met for at least 1 FGID by 40.3% persons who completed the Internet surveys (95% confidence interval [CI], 39.9–40.7) and 20.7% of persons who completed the household surveys (95% CI, 20.2–21.3). FGIDs were more prevalent among women than men, based on responses to the Internet survey (odds ratio, 1.7; 95% CI, 1.6–1.7) and household survey (odds ratio, 1.3; 95% CI, 1.3–1.4). FGIDs were associated with lower quality of life and more frequent doctor visits. Proportions of subjects with irritable bowel syndrome were lower when the Rome IV criteria were used, compared with the Rome III criteria, in the Internet survey (4.1% vs 10.1%) and household survey (1.5% vs 3.5%). Conclusions In a large-scale multinational study, we found that more than 40% of persons worldwide have FGIDs, which affect quality of life and health care use. Although the absolute prevalence was higher among Internet respondents, similar trends and relative distributions were found in people who completed Internet vs personal interviews.The study was funded, in part, by research grants from Ironwood, Shire, Allergan, and Takeda. The study in Malaysia was funded by the Fundamental Research Grant Scheme (FRGS) of the Ministry of Education of Malaysia (Reference: 203.PPSP.6171192). The study in Israel was funded by Takeda-Israel. The study in Romania was funded by the Romanian Society of Neurogastroenterology. None of the funders was involved in the planning, design, implementation, statistical analyses or any other aspect of the study including preparation of the paper or knowledge of its contents

AGA technical review on irritable bowel syndrome

AbstractThe irritable bowel syndrome (IBS) is part of the larger group of functional gastrointestinal (GI) disorders that, despite differences in location and symptom patterns, share common features with regard to their motor and sensory physiology, central nervous system (CNS) relationships, and the approach to patient care.1 IBS is a functional bowel disorder characterized by symptoms of abdominal pain or discomfort that is associated with disturbed defecation.2 This disorder is highly prevalent and can be associated with significant emotional distress, impaired health-related quality of life (HRQL), disability, and high health care costs. Psychosocial factors, although not part of IBS per se, have an important role in modulating the illness experience and its clinical outcome.3GASTROENTEROLOGY 2002;123:2108-213

Translation and validation of a Japanese version of the irritable bowel syndrome-quality of life measure (IBS-QOL-J)

AIMS: To compare quality of life (QOL) for patients with irritable bowel syndrome (IBS) between the U.S. and Japan, it is indispensable to develop common instruments. The IBS-QOL, which is widely used in Western countries, was translated into Japanese as there has been a lack of Japanese disease-specific QOL measures for IBS. METHODS: The original 34 items of the IBS-QOL were translated from English into Japanese through two independent forward translations, resolution, back translation, and resolution of differences. Forty nine patients who had GI symptoms but did not have any organic diseases (including 30 IBS patients diagnosed by Rome II criteria) were recruited from Tohoku University Hospital in Sendai, Japan and completed a Japanese version of the IBS-QOL (IBS-QOL-J) concomitant with a Japanese version of the IBS severity index (IBSSI-J) twice within 7–14 days. RESULTS: The IBS-QOL-J demonstrated high internal consistency (Cronbach's alpha; 0.96) and high reproducibility (intraclass correlation coefficient; 0.92, p < 0.001). Convergent analyses confirmed that the overall score of IBS-QOL-J was significantly correlated with overall severity of IBS symptoms on the IBSSI-J (r = -0.36, p = 0.01) and with the individual items on the IBSSI-J that assess interference with life in general (r = -0.47, p = 0.001) and dissatisfaction with bowel habits (r = -0.32, p < 0.05). Eight patients who reported continuous abdominal pain in the past 6 months had significantly lower scores in the IBS-QOL-J than those who did not (53.7 +- 12.7 vs. 73.6 +- 19.5, p < 0.01). Age, sex, education or marital status did not affect scores on the measure. CONCLUSION: The IBS-QOL-J is a reliable instrument to assess the disease-specific QOL for IBS. Considering cross-cultural comparison, this measure is likely to be a valuable tool to investigate the QOL in Japanese patients with IBS