Risk-based decision-making related to preprocedural coronavirus disease 2019 testing in the setting of GI endoscopy: management of risks, evidence, and behavioral health economics.

BACKGROUND AND AIMS: Controversies exist regarding the benefits and most appropriate approach for preprocedural coronavirus disease 2019 (COVID-19) testing (eg, rapid antigen test, polymerase chain reaction, or real-time polymerase chain reaction) for outpatients undergoing diagnostic and therapeutic procedures, such as GI endoscopy, to prevent COVID-19 infections among staff. Guidelines for protecting healthcare workers (HCWs) from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection from outpatient procedures varies across medical professional organizations. This study provides an evidence-based decision support tool for key decision-makers (eg, clinicians) to respond to COVID-19 transmission risks and reduce the effect of personal biases. METHODS: A scoping review was used to identify relevant factors influencing COVID-19 transmission risk relevant for GI endoscopy. From 12 relevant publications, 8 factors were applicable: test sensitivity, prevalence of SARS-CoV-2 in the population, age-adjusted SARS-CoV-2 prevalence in the patient cohort, proportion of asymptomatic patients, risk of transmission from asymptomatic carriers, risk reduction by personal protective equipment (PPE), vaccination rates of HCWs, and risk reduction of SAE by vaccination. The probability of a serious adverse event (SAE), such as workplace-acquired infection resulting in HCW death, under various scenarios with preprocedural testing was determined to inform decision-makers of expected costs of reductions in SAEs. RESULTS: In a setting of high community transmission, without testing and PPE, 117.5 SAEs per million procedures were estimated to occur, and this was reduced to between .079 and 2.35 SAEs per million procedures with the use of PPE and preprocedural testing. When these variables are used and a range of scenarios are tested, the probability of an SAE was low even without testing but was reduced by preprocedural testing. CONCLUSIONS: Under all scenarios tested, preprocedural testing reduced the SAE risk for HCWs regardless of the SARS-CoV-2 variant. Benefits of preprocedural testing are marginal when community transmission is low (eg, below 10 infections a day per 100,000 population). The proposed decision support tool can assist in developing rational preprocedural testing policies.

Routine assessment of gastrointestinal symptom using a validated questionnaire in the clinical setting to assess the probability of organic or functional gastrointestinal diseases.

BACKGROUND: Patients presenting with gastrointestinal symptoms can be challenging in terms of determining etiology and management strategies. Identifying likely organic pathology is important since it can be treated and may result in further, long-term harm to the patient if not treated. Currently, organic pathology is often identified via invasive procedures such as endoscopy or referral to a medical imaging service. We report on an approach that offers a first step at identifying patients with an organic gastrointestinal disease based on the SAGIS, a validated symptom questionnaire. METHODS: 8,922 patients referred to a tertiary care hospital were classified as having either functional gastrointestinal disease or an organic gastrointestinal disease. A model was developed to distinguish organic from functional symptoms on one random split half of the sample and validated on the other half. The incremental benefit of including psychological conditions and extra-gastrointestinal conditions was also evaluated. KEY RESULTS: Functional gastrointestinal patients scored higher on average than organic patients on all dimensions of the SAGIS and reported higher rates of psychological and extra-gastrointestinal conditions. All five dimensions of the SAGIS provided statistically independent discrimination of organic from functional diagnoses with good overall discrimination (AUC = 0.75). However, there was no noticeable incremental benefit of adding either psychological or extra-gastrointestinal conditions. Model performance was highly reproducible. CONCLUSIONS AND INFERENCES: The proposed algorithm for identifying likely organic gastrointestinal disease applied to symptoms as recorded in the SAGIS questionnaire provides a useful tool for the clinician in deciding what or if further diagnostic testing is required.

Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol.

BACKGROUND: Functional gastrointestinal disorders (FGIDs) are the commonest reason for gastroenterological consultation, with patients usually seen by a specialist working in isolation. There is a wealth of evidence testifying to the benefit provided by dieticians, behavioral therapists, hypnotherapists and psychotherapists in treating these conditions, yet they rarely form a part of the therapeutic team, and these treatment modalities are rarely offered as part of the therapeutic management. There has been little examination of different models of care for FGIDs. We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders. METHODS: The "MANTRA" (Multidisciplinary Treatment for Functional Gut Disorders) study compares comprehensive multi-disciplinary outpatient care with standard hospital outpatient care. Consecutive new referrals to the gastroenterology and colorectal outpatient clinics of a single secondary and tertiary care hospital of patients with an FGID, defined by the Rome IV criteria, will be included. Patients will be prospectively randomized 2:1 to multi-disciplinary (gastroenterologist, gut-hypnotherapist, psychiatrist, behavioral therapist ('biofeedback') and dietician) or standard care (gastroenterologist or colorectal surgeon). Patients are assessed up to 12 months after completing treatment. The primary outcome is an improvement on a global assessment scale at the end of treatment. Symptoms, quality of life, psychological well-being, and healthcare costs are secondary outcome measures. DISCUSSION: There have been few studies examining how best to deliver care for functional gut disorders. The MANTRA study will define the clinical and cost benefits of two different models of care for these highly prevalent disorders. TRIAL REGISTRATION NUMBER: Clinicaltrials.govNCT03078634 Registered on Clinicaltrials.gov, completed recruitment, registered on March 13th 2017. Ethics and Dissemination: Ethical approval has been received by the St Vincent's Hospital Melbourne human research ethics committee (HREC-A 138/16). The results will be disseminated in peer-reviewed journals and presented at international conferences. Protocol version 1.2.

The Nepean Dyspepsia Index is a valid instrument for measuring quality-of-life in functional dyspepsia.

BACKGROUND: The Nepean Dyspepsia Index (NDI) has been in widespread use since its publication in 1999 and the addition of a short form in 2001. The NDI was one of the first disease-specific quality-of-life instruments created for functional dyspepsia (FD). However, its psychometric properties have never been validated in an independent sample. AIM: This study aimed to evaluate the validity and reliability of the NDI in an a-priori driven approach in an independent population. PATIENTS AND METHODS: In 289 individuals who fulfilled the Rome criteria for FD enrolled in a randomized placebo-controlled trial (FD treatment trial), we examined construct validity, convergent validity, and internal consistency. RESULTS: Construct validity was supported in its 25-item unweighted and weighted forms as well as the 10-item short form. All items in the 25-item form yielded considerable (>0.5) standardized loadings on their respective latent variables and all reached statistical significance (P<0.0001), supporting their relationships with the hypothesized domains. Convergent validity was strongly supported, with every domain being correlated with multiple external instruments; the majority of correlations were in the range 0.3-0.5 (in absolute values). The items comprising each domain showed good internal consistency, with the lowest value of Chronbach α at 0.80. Scores based on the short form (10-item) version of the NDI correlated strongly with the full 25-item form (tension ρ=0.88, interference ρ=0.94, eat/drink ρ=0.95, knowledge ρ=0.84 and work/study ρ=0.97; all P<0.0001). CONCLUSION: The NDI is a valid instrument that can be used to measure the disease-specific impact of FD on quality of life.

Development of a real-time patient-reported outcome measure for symptom assessment in patients with functional dyspepsia using the experience sampling method.

BACKGROUND: Patient-reported outcome measures (PROMs) are used to assess symptoms in patients with functional dyspepsia (FD). Current end-of-day questionnaires have several limitations including sensitivity to recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments across momentary states in daily life and therefore less sensitive to these limitations. This study describes the development of a novel PROM based on ESM technology. METHODS: An initial draft of the PROM was developed based on literature. Focus group interviews with FD patients according to Rome IV criteria, and an expert meeting with international opinion leaders in the field of functional gastrointestinal disorders were conducted in order to select items for the PROM. Cognitive interviews were performed to evaluate patients' understanding of the selected items and to create the definitive PROM. KEY RESULTS: A systematic literature search revealed 59 items across four domains (ie, physical status; mood and psychological factors; context and environment; and nutrition, medication, and substance use). After patient focus group interviews and an international expert meeting, the number of items was reduced to 33. Cognitive interviews resulted in some minor linguistic changes in order to improve patients' understanding. CONCLUSIONS AND INFERENCES: A novel digital ESM-based PROM for real-time symptom assessment in patients with functional dyspepsia was developed. This novel PROM has the potential to identify individual symptom patterns and specific triggers for dyspeptic symptoms, and optimize treatment strategies.

Gastrointestinal Symptoms in Diabetes: Prevalence, Assessment, Pathogenesis, and Management.

If you haven't measured something, you really don't know much about it.-Karl Pearson (attributed)Gastrointestinal (GI) symptoms represent an important and often unappreciated cause of morbidity in diabetes, although the significance of this burden across the spectrum of patients and the underlying pathophysiology, including the relationship of symptoms with glycemic control, remain poorly defined. The relevance of GI symptoms and the necessity for their accurate assessment have increased with the greater focus on the gut as a therapeutic target for glucose lowering. This review addresses the prevalence, assessment, pathogenesis, and management of GI symptoms in diabetes, beginning with broad principles and then focusing on specific segments of the GI tract. We initially performed a literature search of PubMed by using synonyms and combinations of the following search terms: "gastrointestinal symptoms", "diabetes", "prevalence", "pathogenesis", "diagnosis", and "management". We restricted the search results to English only. Review papers and meta-analyses are presented as the highest level of evidence where possible followed by randomized controlled trials, uncontrolled trials, retrospective and observational data, and expert opinion.

The clinical academic workforce in Australia and New Zealand: report on the second binational summit to implement a sustainable training pathway.

There has been a decline in the proportion of clinical academics compared with full-time clinicians, since 2004. A Working Party was established to help develop and implement a model for the training of clinical academics. After a highly successful first summit in 2014 that summarised the challenges faced by clinical academics in Australia and New Zealand, a second summit was convened late in 2015 to report on progress and to identify key areas for further action. The second summit provided survey results that identified the varied training pathways currently offered to clinical academics and the institutions willing to be involved in developing improved pathways. A literature review also described the contributions that clinical academics make to the health sector and the challenges faced by this workforce sector. Current training pathways created for clinical academics by Australasian institutions were presented as examples of what can be done. The perspectives of government and research organisations presented at the summit helped define how key stakeholders can contribute. Following the summit, there was a strong commitment to continue to work towards developing a sustainable and defined training pathway for clinical academics. The need for a coordinated and integrated approach was highlighted. Some key objectives were agreed upon for the next phase, including identifying and engaging key advocates within government and leading institutions; publishing and profiling the contributions of successful clinical academics to healthcare outcomes; defining the stages of a clinical academic training pathway; and establishing a mentoring programme for training clinical academics.

Hill classification is superior to the axial length of a hiatal hernia for assessment of the mechanical anti-reflux barrier at the gastroesophageal junction.

BACKGROUND AND STUDY AIMS: The pathogenesis of gastroesophageal reflux disease (GERD) is multifactorial, including the mechanical anti-reflux barrier of the gastroesophageal junction. This barrier can be evaluated endoscopically in two ways: by measuring the axial length of any hiatal hernia present or by assessing the gastroesophageal flap valve. The endoscopic measurement of axial length is troublesome because of the physiological dynamics in the area. Grading the gastroesophageal flap valve is easier and has proven reproducible. The aim of the present study was to compare the two endoscopic grading methods with regard to associations with GERD. PATIENTS AND METHODS: Population-based subjects underwent endoscopic examination assessing the axial length of hiatus hernia, the gastroesophageal flap valve using the Hill classification, esophagitis using the Los Angeles (LA) classification, and columnar metaplasia using the Z-line appearance (ZAP) classification. Biopsies were taken from the squamocolumnar junction to assess the presence of intestinal metaplasia. Symptoms were recorded with the validated Abdominal Symptom Questionnaire. GERD was defined according to the Montreal definition. RESULTS: In total, 334 subjects were included in the study and underwent endoscopy; 86 subjects suffered from GERD and 211 presented no symptoms or signs of GERD. Based on logistic regression, the estimated area under the curve statistic (AUC) for Hill (0.65 [95 %CI 0.59 - 0.72]) was higher than the corresponding estimate for the axial length of a hiatal hernia (0.61 [95 %CI 0.54 - 0.68]), although the difference was not statistically significant (P = 0.225). CONCLUSION: From our data, and in terms of association with GERD, the Hill classification was slightly stronger compared to the axial length of a hiatal hernia, but we could not verify that the Hill classification was superior as a predictor. The Hill classification may replace the axial length of a hiatal hernia in the endoscopic assessment of the mechanical anti-reflux barrier of the gastroesophageal junction.

Value of the "Test & Treat" Strategy for Uninvestigated Dyspepsia at Low Prevalence Rates of Helicobacter pylori in the Population.

BACKGROUND AND AIM: In populations with a low prevalence rate of Helicobacter pylori (H. pylori) infection from Western countries, guidelines for the management of uninvestigated dyspepsia generally recommend that the "test and treat" strategy should be avoided in favor of empiric proton-pump inhibitor therapy in younger patients (on average < 50 years of age) without alarm symptoms and signs. The prevalence of H. pylori infection has fallen from about 30% to about 10% in Sweden and other countries. We aimed to explore whether the rationale for test and treat is relevant in contemporary clinical practice. MATERIALS AND METHODS: In settings with an infection rate in the adult population of 30% and 10%, we modeled the positive and negative predictive values for indirect (nonendoscopy) tests on current H. pylori infection with a presumed sensitivity and specificity of 95%. We then calculated the difference in false-negative and false-positive test outcome, and eradication prescription rates in the two scenarios. RESULTS: While the positive predictive value for the test decreased from 0.89 to 0.68 when the prevalence of H. pylori fell from 30% to 10%, there were only 1% more false-negative tests and 1% less false-positive tests. The eradication prescription rate would decrease by 18% with a 10% prevalence rate. CONCLUSION: The recommendation to stop applying "test and treat" at lower prevalence rates of H. pylori should be reconsidered. The test and treat strategy is the preferred approach for most patients who present with dyspepsia.

Multi-Dimensional Gastrointestinal Symptom Severity Index: Validation of a Brief GI Symptom Assessment Tool.

UNLABELLED: Few instruments have been developed and validated for the evaluation of multi-dimensional GI symptoms. The Gastrointestinal Symptoms Severity Index (GISSI), a multi-dimensional, self-report instrument, was designed as a brief measure of the frequency, severity, and bothersomeness of individual GI and pelvic floor/urogynecologic symptoms. AIM: To report the psychometric properties of the GISSI subscales, including factorial structure, validity, and internal consistency. METHODS: The GISSI included 32 items that assessed upper and lower GI symptoms and seven items related to pelvic floor/urogynecologic symptoms. A total of 934 patients presenting for upper and lower GI complaints completed the questionnaire between January 2013 and December 2013. The sample was randomly split into derivation (n = 466) and validation datasets (n = 468). A non-patient sample of 200 was collected separately. RESULTS: Exploratory factor analysis supported a six-factor model for the derivation sample that accounted for 69.3 % of the total variance. The six GI symptom clusters were labeled as constipation/difficult defecation (five items), abdominal pain/discomfort (four items), dyspepsia (four items), diarrhea/anal incontinence (four items), GERD/chest symptoms (four items), and nausea/vomiting (two items). Inclusion of additional items related to female pelvic floor/urogynecologic symptoms resulted in a separate factor. Confirmatory factor analysis of the validation dataset supported the a priori hypothesized six-factor measurement model (Χ (2)(428) = 1462.98; P < 0.001; GFI = .88; RMSEA = .051). CONCLUSION: The GISSI demonstrated good to excellent psychometric properties and provided multi-dimensional scaling of prominent GI symptom clusters. Further validation may provide an efficient, valid, and reliable measure of patient-reported clinical outcomes.

Predictors of response rates to a long term follow-up mail out survey.

OBJECTIVE: Very little is known about predictors of response rates to long-term follow-up mail-out surveys, including whether the timing of an incentive affects response rates. We aimed to determine whether the timing of the incentive affects response rates and what baseline demographic and psychological factors predict response rates to a 12 year follow-up survey. STUDY DESIGN AND SETTING: Participants were 450 randomly selected people from the Penrith population, Australia who had previously participated in a mail-out survey 12 years earlier. By random allocation, 150 people received no incentive, 150 received a lottery ticket inducement with the follow-up survey and 150 received a lottery ticket inducement on the return of a completed survey. RESULTS: The overall response rate for the study was 63%. There were no significant differences in terms of response rates between the no incentive (58.8%;95%CI 49.8%,67.3%), incentive with survey (65.1%;95%CI 56.2%,73.3%) and promised incentive (65.3%;95%CI 56.1%,73.7%) groups. Independent predictors of responding to the 12 year survey were being older (OR=1.02, 95%CI 1.01,1.05,P=0.001) and being less neurotic as reported on the first survey 12 years earlier (OR=0.92, 95%CI 0.86,0.98, P=0.010). CONCLUSIONS: Psychological factors may play a role in determining who responds to long-term follow-up surveys although timing of incentives does not.

Prevalence correlates and impact of fecal incontinence among older women.

BACKGROUND: Fecal incontinence is a common problem that has been associated with anatomic, physiological, and medical conditions. There are very few data on the factors associated with fecal incontinence in elderly women. OBJECTIVES: We aimed to determine the factors associated with fecal incontinence via a population-based survey in a large cohort of elderly Australian women. DESIGN AND SETTING: Data from a large longitudinal population-based study of elderly Australian women aged 82 to 87 years were analyzed. PATIENTS: Participants were 5560 women (aged 82-87 years) who participated in the Australian Longitudinal Study on Women's Health; 4815 women responded to questions relating to fecal incontinence. MAIN OUTCOME MEASURES: Fecal incontinence was defined as leakage of liquid and/or solid stool at least once per month over the past 12 months. Self-reported medical conditions and lifestyle factors as well as demographic factors were recorded. RESULTS: The prevalence of fecal incontinence was 10.4% (95% CI, 9.6-11.3) (n = 510). The prevalence was significantly higher among institutional- versus community-dwelling women (14.1% vs 9.7%; p = 0.0002). Univariately, lifestyle factors including fruit intake and fluid intake, along with a range of comorbidities, were associated. However, independent factors for fecal incontinence among community-dwelling women included diabetes mellitus (OR, 1.51; 95% CI, 1.14-2.01; p = 0.004), depression (OR, 1.84; 95% CI, 1.30-2.62; p = 0.001), urinary incontinence (OR, 2.29; 95% CI, 1.83-2.86; p < 0.0001), and osteoarthritis (OR, 0.73; 95% CI, 0.57-0.94; p = 0.013). Among institutional-dwelling women, however, we found urinary incontinence (OR, 4.43; 95% CI, 2.83-6.93; p < 0.0001) and poorer general health (OR, 0.98; 95% CI, 0.97-0.99; p = 0.003) to be independently associated. LIMITATIONS: This is a cross-sectional study, which prevents making conclusions about the cause and effect of observed correlations. CONCLUSIONS: The independent factors associated with fecal incontinence in this population do not appear readily modifiable, and many previously identified risk factors may not be important in the elderly women with fecal incontinence.

New treatments for IBS.

IBS is a common disorder that affects approximately 5-20% of the populations of Western countries; the main symptoms are abdominal pain and erratic, altered bowel habits, often accompanied by bloating. Despite an array of available pharmacological and nonpharmacological treatments aimed at a wide variety of gastrointestinal and brain targets, many patients do not report adequate symptom relief. The effect of IBS on an individual can be enormous, and the societal and financial costs overall are high, which is indicative of an unmet need for effective IBS treatments. Intense research efforts are ongoing that range from the development of new molecules for pharmacological therapies to testing the utility of internet technology to facilitate widespread delivery of efficacious behavioural therapy. This Review discusses the latest treatments for IBS, including novel nonpharmacological and pharmacological approaches. We have included estimates of the number needed to treat and the number needed to harm for selected treatments. Emerging and potential future treatments are included, with the data supporting an optimistic view about the future of IBS therapeutics. The ability to optimize therapy by individualizing management whilst also avoiding harm remains the key to achieving the best possible outcomes with currently available therapeutics.

Functional Dyspepsia Treatment Trial (FDTT): a double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics.

BACKGROUND: Functional dyspepsia (FD) is a common problem affecting up to 10-25% of individuals. FD accounts for significant health care costs and affects quality of life but has no definitive treatment. OBJECTIVES: The Functional Dyspepsia Treatment Trial (FDTT) aims to test whether treatment with an antidepressant (amitriptyline or escitalopram) leads to improvement of symptoms in patients with moderate to severe FD. DESIGN: The FDTT is an international multicenter, parallel group, randomized, double-blind, placebo-controlled trial to evaluate whether 12 weeks of treatment with escitalopram or amitriptyline improves FD symptoms compared to treatment with placebo. Secondly, it is hypothesized that acceleration of solid gastric emptying, reduction of postprandial satiation, and enhanced gastric volume change with a meal will be significant positive predictors of short- and long-term outcomes for those on antidepressants vs. placebo. The third aim is to examine whether polymorphisms of GNß3 and serotonin reuptake transporter influence treatment outcomes in FD patients receiving a tricyclic antidepressant, selective serotonin reuptake inhibitor therapy, or placebo. METHODS: The FDTT enrollment began in 2006 and is scheduled to randomize 400 patients by the end of 2012 to receive an antidepressant or placebo for 12 weeks, with a 6-month post-treatment follow-up. The study incorporates multiple validated questionnaires, physiological testing, and specific genetic evaluations. The protocol was approved by participating centers' Institutional Review Boards and an independent Data Safety Monitoring Board was established for monitoring to ensure patient safety and a single interim review of the data in December 2010 (ClinicalTrials.gov number NCT00248651).

Excess comorbidity prevalence and cost associated with functional dyspepsia in an employed population.

BACKGROUND: Limited published data exist on the associated comorbid conditions with functional dyspepsia (FD). AIMS: This study aimed to assess the prevalence, services, and costs related to comorbid conditions associated with FD and the risk of having FD for each comorbid condition. METHODS: A retrospective database analysis was undertaken using payroll data and adjudicated claims from January 1, 2001, through December 31, 2004 among >300,000 employees. Employees with FD were compared to propensity-score-matched employees without FD (controls). Outcome measures included the prevalence, costs, and utilization of health services for comorbid conditions as defined by the Agency for Healthcare Research and Quality (AHRQ) and the odds ratios of having FD from a multivariate model. RESULTS: FD employees (N = 1,669) and a 50:1 matched control cohort (N = 83,450) were compared. Compared to matched controls, FD employees were more likely to have all major diagnostic categories. Moreover, 199/261 of the AHRQ's specific categories were more common in the FD cohort. Annual medical costs for the FD cohort were greater than for controls in 155/261 (59%) specific categories and significantly greater (P ≤ 0.05) in 76 categories (29%). Similarly, services were greater for 179/261 (69%) specific categories and significantly greater (P ≤ 0.05) in 110 categories (42%). In a multivariate model, esophageal disorders, gastritis and duodenitis, and abdominal pain were the most associated with having FD (odds ratios 3.8, 3.7, and 3.6, respectively). Only hypertension complications and disorders of the teeth and jaw were significantly negatively associated with FD. CONCLUSION: There is unexplained excess comorbidity associated with FD which may be a major determining factor for excess healthcare services and costs.

What level of IBS symptoms drives impairment in health-related quality of life in community subjects with irritable bowel syndrome? Are current IBS symptom thresholds clinically meaningful?

BACKGROUND: Quality of life is impaired in some people with IBS, but the level of symptoms that may drive this impairment is unclear. AIMS: We aimed to identify whether current frequency and severity cut-offs for IBS-type symptoms are associated with a clinically meaningful impairment of quality of life in the community. METHODS: People who met modified Rome III criteria for IBS (n = 201) and controls (n = 1,904) were assessed. Frequency of IBS symptoms was grouped a priori into 'less frequent' (not at all and sometimes) and 'more' frequent (often, very often and almost always). Severity of abdominal pain was grouped into 'mild' (very mild and mild) and severe (moderate, severe and very severe). Mental and physical functioning was measured using the valid SF-12, with 'normal' functioning (defined as a score of >43 and >48) and 'impaired' functioning (defined as a score of ≤43 and ≤48), respectively. Psychological variables were assessed via valid self-report. RESULTS: Having 'more' versus 'less' severe abdominal pain (OR = 9.41; 95% CI 1.17-75.43, P = 0.03) and 'more' versus 'less' frequent diarrhoea (OR = 2.19; 95% CI 1.13-4.26, P = 0.02) along with increasing age (OR = 1.03; 95% CI 1.01-1.05, P = 0.003) were significant independent predictors of having impairment in physical functioning. In terms of psychological factors, having higher levels of depression (OR = 1.61; 95% CI 1.36-1.91) and somatic distress (OR = 1.17; 95% CI 1.09-1.27) were independently associated with mental and physical impairment, respectively. CONCLUSION: The current frequency and severity threshold cut-offs for IBS symptoms in the Rome III criteria are associated with a clinically meaningful impairment of quality of life in community subjects with IBS.