International Foundation for Functional Gastrointestinal Disorders

Introduction: Symptoms of irritable bowel syndrome with diarrhea (IBS-D) impose a significant burden to patients. Our study examined disease burden and care-seeking behavior of patients with IBS-D. Methods: A cross-sectional, on-line health survey collected data during 8/2020-12/2021 from US adults. IBS-D patients were defined using Rome IV criteria. Health outcomes comparing IBS-D patients to controls included anxiety and depression screeners, health-related quality of life (HRQoL) and productivity measures. Care, treatment and symptom burden were assessed for IBS-D patients. Differences in anxiety, depression, HRQoL, and productivity between IBS-D patients and the general population were assessed with a 1:1 matched sample by sex, age, race, region and Charlson Comorbidity Index score. Categorical data were described by percentage and continuous data by mean and standard deviation. Means were compared with ANOVA and proportions with chi-square tests. Results: Data was collected from 29,359 participants. Matching IBS-D participants resulted in 669 patients and 669 controls. Most patients were female (74.6%), White (84.0%), with a mean age of 41.9 years. IBS-D patients had significantly higher proportions of moderate to severe anxiety and depression (p < .001) and significantly lower HRQoL vs controls (p < .001). Health impact on work productivity and daily activity was significantly higher among IBS-D patients vs controls (Table). Of IBS-D patients, 91.5% sought care for their symptoms, 59.3% within the past year. Of those having an ER visit/hospitalization in the past year (17.3%), abdominal pain was the most reported reason (87.1%). 65.9% of IBS-D patients reported currently taking an Rx and/or an OTC for their symptoms (13.2% Rx alone, 13.9% Rx and OTC, and 38.9% OTC alone). Abdominal pain and abdominal discomfort were the symptoms most experienced (71.0% and 70.9%, respectively). Abdominal pain was reported to be the most bothersome (34.5%) (Figure). IBS-D patients currently taking an Rx with/without an OTC were more satisfied with the control of bowel (39.2% vs 21.5%) and abdominal (40.3% vs 22.7%) symptoms than those currently taking an OTC alone. Conclusion: This large survey study demonstrates that the health impact of IBS-D is high. Nearly 1 in 5 patients sought care at an ER for their symptoms. Abdominal pain and discomfort are common bothersome symptoms with patients reporting better control with Rx medications compared to OTC agents.Figure 1.: Symptom Experience, Frequency and Bothersomeness Table 1. - Characteristics of the Rome IV IBS-D Cohort vs Controls (1) WPAI fielded 12/20-12/21: Rome IV IBS-D cohort n=463; control n=397. (2) GAD-7: Generalized Anxiety Disorder, 7-item; range: 0-21. (3) PHQ-9: Patient Health Questionnaire, 9-item; range: 0-29. (4) Veterans RAND 12-item Health Survey (VR12). (5) Question fielded 12/20-12/21: Rome IV IBS-D cohort n=251; control n=233 Rome IV IBS-D Cohort(N=669) Control(N=669) Sig. Female 74.6% 74.6% 1.000 Age, mean (SD) 41.9 (15.0) 41.9 (15.0) 0.990 Black or African American 7.8% 7.8% 1.000 White 84.0% 84.0% Other 8.2% 8.2% Proportion of Hispanic, Latino or Spanish origin 7.8% 8.5% 0.617 Northeast 17.2% 17.2% 1.000 Midwest 22.6% 22.6% South 42.8% 42.8% West 17.5% 17.5% Charlson Comorbidity Index (CCI) score, mean (SD) 0.6 (1.1) 0.6 (1.1) 1.000 Body Mass Index (BMI) (lbs/in2), mean (SD) 30.2 (9.0) 27.9 (7.4) < 0.001 Proportion employed per Work Productivity and Impairment (WPAI) (1) 54.2% 58.7% 0.187 Median household income (Census derived from zip code), mean (SD) 65,468(28,360) 65,459(26,647) 0.996 Anxiety (GAD-7 [2]) score, mean (SD) 9.9 (6.1) 6.8 (5.8) < 0.001 Depression (PHQ-9 [3]) score, mean (SD) 11.4 (7.3) 7.9 (7.1) < 0.001 Chronic pain 61.4% 38.6% < 0.001 Migraine 64.2% 35.8% < 0.001 Insomnia 67.7% 32.3% < 0.001 GERD 75.9% 24.1% < 0.001 VR-12 Mental Component Summary (MCS [4]), mean (SD) 36.7 (12.5) 43.9 (11.8) < 0.001 VR-12 Physical Component Summary (PCS [4]), mean (SD) 40.3 (11.2) 44.4 (10.6) < 0.001 VR-12 Health utility (VR-6D [4]), mean (SD) 0.60 (0.11) 0.67 (.12) < 0.001 Health problems affected work productivity rating (0-10 scale), mean, SD (5) 3.1 (2.9) 2.1 (2.8) < 0.001 Health problems affected daily activities rating (0-10 scale), mean, SD (1) 4.3 (3.2) 2.6 (3.1) < 0.001

The impact of gastroparesis on patients from the patient's viewpoint is needed to better address treatment priorities. The aims of this study were to: (1) Delineate burdens and concerns of patients with gastroparesis; (2) investigate specific symptoms contributing to impaired quality of life (QOL) in gastroparesis. The International Foundation for Functional GI Disorders gastroparesis survey questionnaire was developed to describe patients' viewpoint about their experience with gastroparesis and included Patient Assessment of Upper GI Symptoms (PAGI-SYM) and SF-36 QOL survey. A total of 1423 adult patients with gastroparesis completed the survey. Average duration of gastroparesis symptoms was 9.3years with time from onset to diagnosis 5.0years. Patients felt that they receive good information regarding treatment options from physicians, the Internet, and Facebook. Patients rated their satisfaction with available treatment for their gastroparesis as dissatisfied (33%), somewhat dissatisfied (27%), neutral (14%), somewhat satisfied (15%), and satisfied (4%). Patients felt that gastroparesis symptoms that are most important to improve with treatment are nausea, stomach pain, and vomiting. Overall, there was a decreased quality of life by SF-36. Physical health QOL score was negatively correlated with symptoms including nausea (r=-0.37), upper abdominal pain (r=-0.37), and early satiety (r=-0.37). This large series of patients with gastroparesis describes their burdens, concerns, and QOL. Nausea, vomiting, early satiety, and abdominal pain are important symptoms for treatment. Many patients are not satisfied with current treatments, wanting specific treatments for their disorder. Interestingly, a large number of patients find out about treatments, not only from their physician, but also using the Internet including social media.

The Gastroparesis Cardinal Symptom Index (GCSI) is a patient-reported outcome for gastroparesis using a two-week recall period. To minimize potential patient recall effects, a daily diary version of the GCSI (GCSI-DD) was developed. To evaluate the content validity of GCSI-DD for the symptoms in patients with documented gastroparesis, to capture symptom variability over time and to compare responses of this GCSI-DD to the original GCSI. In gastroparesis adults with delayed gastric emptying, cognitive debriefing interviews were conducted to elicit their perspective on relevant symptoms of gastroparesis and relevant recall periods and to evaluate patient understanding of GCSI-DD. Patients completed the GCSI-DD daily over a 2-week period and completed the GCSI at baseline and the 2-week follow-up visit. Twelve gastroparesis patients, of whom five were diabetic and nine women, reported nausea (100%), vomiting (100%), stomach fullness (75%), bloating (58%) and loss of appetite (50%) were important symptoms. All patients understood diary instructions and item content and reported that the diary captured their gastroparesis symptom experience; 83% considered response scales adequate. There was significant daily variability in GCSI-DD scores. Mean GCSI-DD subscale and total scores over 2 weeks correlated strongly (all r > 0.90) with GCSI scores at 2-week follow-up. The GCSI-DD includes symptoms relevant to patients with gastroparesis, captures daily variability of those symptoms and has psychometric properties consistent with a good patient-reported outcome endpoint for gastroparesis clinical trials.

Although clinicians generally make treatment decisions in irritable bowel syndrome (IBS) related to the type of symptoms, other factors such as the perceived severity and the risks patients are willing to tolerate for effective treatment are also important to consider. These factors are not fully understood. To describe among patients with IBS their symptoms and severity, quality of life and health status, medications taken, and the risk that they would take to continue medications for optimal relief. Adult patients diagnosed with IBS who accessed the websites of the International Foundation for Functional GI Disorders or the University of North Carolina Center for Functional GI Disorders filled out questionnaires to address the study aims. The 1966 respondents (83% female, 91% white, 78% US/Canada) reported impaired health status: restricting on average 73 days of activity in a year, having poor health-related quality of life particularly with dietary restrictions, mood disturbance, and interference with daily activity, and 35% reported their symptoms as severe defined primarily as pain, bowel difficulties, bloating, and eating/dietary restrictions). These symptoms were reported in some combination by over 90%, and 35.1% endorsed all 4 items. To receive a treatment that would make them symptom free, patients would give up 25% of their remaining life (average 15 y) and 14% would risk a 1/1000 chance of death. Most of the medications being taken were for pain relief and 18% were taking narcotics. Complementary and alternative treatments were used by 37%. Patients accessing IBS informational websites report moderate-to-severe impairments in health status, and would take considerable risk to obtain symptom benefit. There is an unmet need to find effective treatments for patients with IBS and regulatory agencies might consider raising risk-benefit ratios when approving new medications for IBS.

Irritable Bowel SyndromeI rritable bowel syndrome (IBS) is a gastrointestinal (digestive) problem that affects up to 15% of adults (during their lifetimes) in developed countries.Irritable bowel syndrome is a functional disorder, meaning that tests do not reveal a cause in the structure of the bowel such as an obstruction or a tumor.Irritable bowel syndrome is completely different from Crohn disease or ulcerative colitis, which are inflammatory diseases of the intestine.Having IBS does not increase the risk of developing colon cancer.Gastroenterologists (doctors with specialized training in treating disorders of the bowel and other digestive organs) may be consulted to help diagnose and treat IBS.The August 18, 2004, issue of JAMA includes an article about IBS that reviews evidence that IBS may be related to abnormal fermentation (chemical breakdown) of food by bacteria inside the bowel.