Differences in productivity QOL, and resource use in newly diagnosed and established irritable bowel syndrome (IBS) patients

IBS patients were entered into a prospective observational community-based registry. Baseline data on demographics, insurance coverage, IBS characteristics, patients' quality of life (QoL) (using the IBSQOL questionnaire), lost workplace productivity and activity time, and IBSrelated resource use were collected. Data were analyzed and compared for newly diagnosed patients, identified through the screening process, and established (previously diagnosed) IBS patients. Results: We collected complete d ata on 736 established and 690 newly diagnosed patients. Resource use for IBS symptoms was in general similar between the two patients groups in terms of inpatient admissions and office/clinic visits services. Previously diagnosed IBS patients had, however, twice as many E.R. and 75% more counseling visits than newly diagnosed patients did in a 3-month period. Established IBS patients lost 40% more clays of work productivity in the last 4 weeks than newly diagnosed patients (3.0 vs. 2.1 median days) but no difference was observed in leisure activity time (about 8 median days in each group). Established patients exhibited significantly lower scores than newly diagnosed patients on 8 out of 9 dimensions of the IBSQoL questionnaire as weft as more limited ability to travel. However, overall level of satisfaction with previous treatments (OTCand/or prescription drugs) was similar in the two groups and the same proportion of patients used OTC medications to treat their IBS (62%). Conclusion: IBS represents a substantial burden to patients and payers, even long after it has been diagnosed. The fact that established patients resort to OTC drugs as often as newly diagnosed patients, have significantly lower OoL scores, and are more likely to use E.R. and counseling services, may indicate that no current long-term medical management program has been able to adequately address the multiple symptoms of IBS.

3213 Concordance Between Rome and Rome II Criteria for Chronic Constipation. A Population-Based Study. Vicente Garrigues, tnmaculada Bau, Guillermo Bastida, Consuelo Galvez, Julio Ponce, Hosp LA FE, Valencia Spain Rome II criteria have made changes in the diagnosis of some functional bowel disorders. Chronic constipation is diagnosed when two or more of the following symptoms are present at least 12 weeks in the preceding 12 months: 1) Straining; 2) Lumpy or hard stools; 3) Sensation of incomplete evacuation;4) Sensation of anorectal obstruction/blockade; 5) Manual maneuvers to facilitate defecations; and 6)<3 defecations/week. Aim: To analyze Rome II criteria for chronic constipation, evaluating the concordance with Rome criteria and calculating the diagnostic utility of each symptom. Methods: A random sample of 489 residents of Aidaya a Mediterranean city in Spain, with 23.425 inhabitants-, aged 18-65 years was mailed a questionnaire to investigate their bowel habits. Response was obtained from 349 subjects (71.5%). Prevalence of self-reported constipation and functional constipation according to Rome and Rome II criteria was estimated. Positive, negativeand global (K) agreement between Rome and Rome II criteria were calculated. Also, sensitivity and specificity for diagnosis of constipation was calculated for each symptom included in Rome II criteria. Results: 1. Prevalenceof constipation (95% CI) can be seen in the Table below. 2. Concordance between Rome and Rome II criteria was very good. Positive agreement 0.92; negative agreement 0.98; and global(K) 0.90. Nine subjects with obstructed defecation were only detected by Rome II; and 2 subjects with <2 defecations/waek were only detected by Rome criteria. 3. Values of sensitivity and specificity for each Rome II symptom were: 1)78/99; 2)84/95; 3)43/99; 4)66/ 99; 5)32/97; 6)31/98. Conclusions: 1. Rome and Rome II criteria are similar for the diagnosis of chronic constipation. Rome II criteria allows subjects with obstructed defecation to be diagnosed as chronic constipation. 2. All symptoms in Rome II criteria are absent in most subjects without chronic constipation; however, some of them, mainly manual maneuvers to facilitate defecations and <3 defecations/week are also absent in many subjects with chronic constipation.

Total Serf-reported Rome RomeII

29.5(24.7-34.3) 19.2(15.1-23.3) 212(16.9-25.5)

3216 HeatB Related Quality of Life in Irritable Bowel Syndrome:A Community Based

study Kevin W. Olden, Mayo Clin Scoftsdale, Scottsdale, AZ; William D. Chey, Univ of Michigan, Ann Arbor, MI; John Boyle, SRBI, Silver Spring, MD; Eric G. Carter, Glaxo Wellcome Inc, Raleigh Durham, NC; Lin Chang, UCLA, Los Angeles, CA Background/Objectives:Health related quality of life (HRQL) in irritable bowel syndrome (IBS) has been traditionally measured by evaluating patients in a treatment setting. The purpose of this study was to evaluate HRQLand health care utilization in a community based, randomly selected sample of women with and without self reported IBS. Methods: Using a random digit dialing method, 21,043 U.S. households were screened for women respondents who ware asked if they bad active IBS. Positive responses led to a full interview that included HRQL and other issues relating to IBS. Interviews were completed with 1,014 women with IBS. An additional 1,010 women without IBS were similarly interviewed. Conclusions: In a community sample, women with IBS had significantly lower quality of life and greater health care utilization compared to women without IBS. Women with IBS had poorer general health status and greater activity limitation than non-IBS controls. IBS patients in the community were significantly more likely to have undergone abdominal surgeries, missed time from work or school along with other activity limitation, and visited their physicians more frequently comparedto women without IBS. Our data confirms that IBS presents a significant burden of illness both socially and economically, and this finding is not limited to patients studied in treatn~nt settings. Supported by Glaxo-Wellcome

Female 40.1(33.047.2) 28.6(22.0-35.1)

32.4(25.6-39.2)

18.0(12.1-23.8) 9.0(4.6-13.3) 9.0(5.1-14.4)

3214 Bowel Habit Predominance Has A Significant Impact On SymptomsAnd Dally Activities In Women With IBS. Lin Chang, UCLNCURE Neuroenteric Disease Prog, UCLA Sch of Medicine, Los Angeles, CA; Kevin W. Olden, Mayo Clin, Scottsdale, AZ; Eric G. Carter, US Medical Affairs, Glaxo Wellcome Inc, Research Triangle Park, NC; John Boyle, Schulman, Ronca and Bucuvelas, Inc, Silver Spring, MO; William D. Chey, Univ of Michigan, Ann Arbor, MI BACKGROUND: Irritable bowel syndrome (IBS) has been associated with higher health care utilization, work and school absences,and poorer quality of life. Although bowel habit predominance in IBS may have profound influences on physiologic and treatment responses, its significance on these factors is not well known. AIM: To evaluate if symptom severity, impact on daily activities, and health care utilization differs between IBS females with predominant diarrhea (IBS-D) and constipation (IBS-C). METHODS:A national probability sample of women diagnosed with IBS was identified and interviewed by telephone screening of a national random digit dialing sample of telephone households. IBS-D was defined as > 3 BMs/day and/or loose/watery stools and absence of hard or lumpy stools. IBS-C was defined as < 3 BMs/ week and/or hard or lumpy stools and absenceof loose or watery stools. RESULTS: Interviews were completed with 1014 out of 1279 IBS patients (79.3%). Mean age was 48 years and 90% were Caucasian. 381 (38%) met IBS-D criteria and 204 (20%) met IBS-C criteria. A significantly higher number of women with IBS-D reported intolerable abdominal pain or discomfort compared to women with IBS-C (44.5% vs. 35.5%, p < 0.05). Urgency was the most bothersome symptom in 32% of IBS-D hut in only 5.4% of IBS-C (p < 0.001). Bloating was the most bothersome symptom in 42.6% of IBS-C hut in only 23.4% of IBS-D (p < 0.001). Compared to IBS-C, women with IBS-D reported that their symptoms led to a greater number of days missed from work or school (9.0 vs. 5.7, p < 0.05) and that interfered with their daily activities (21.2 vs. 9.0, p < 0.001) over the past 12 mos. A~ough women with IBS-D reported spending more nights in the hospital in the past year than IBS-C (7.6 vs. 3.2, p = 0.001), there were no group differences in number of hospitalizations, physician visits, or previous surgeries. IBS-D patients were more likely to use prescription medications in the past 3 mos than IBS-C (35.1% vs. 24.3%, p < 0.05), but there were no group differences in use of over-the-counter medications, or non-pharmacologic treatments. CONCLUSION: While both IBS-O and IBS-C have a major impact on daily activities and health care utilization, the differences between IBS-D and IBS-C suggests that IBS-D may be associated with a greater economic and health care burden than IBS-C. These differences also suggest that bowel habit predominance is an important factor to consider in clinical research design, outcome measures and data interpretation. Supported by Glaxo Wellcome Inc.

Results

Decre~ed life satisfaction AcUutty limitation Any sick days in last year Any days in bed in last 30 days Poor general health status Abdominal surgery (non-C section) Any hospitatizatons in last year Physician visits in last year

IBS (%)

Non.IBS(%)

p

64.0 62.4 55.3 41.6 29.0 58.8 183 8.4*

49.3 26.5 48.7 16.6 10.0 31.9 f f .6 3.7*

<0.001 <0.001 <0.01 <0.001 <0.001 <0.001 <0.001 <0.001

*Mean no. of physician visits

3217 The Canadian Population Constipation Survey: Prevalence, Rome II Adjustment And Health Care Seeking. Pierre Pare, CHUQ- L'HoteI-Dieu de Quebec, Quebec, PQ Canada; Simon Ferrazzi, JanssenOrtho Inc, Toronto Canada; W Grant Thompson, Unlv of Ottawa, Ottawa, ON Canada; E Jan Irvine, McMaster Univ, Hamilton Canada; Laureen Rance, Janssen-Ortho Inc, Toronto Canada Purpose: To estimate the prevalenceof self-reported and Rome II defined functional constipation (FC) and to analyze the influence of gender and age on health care seeking. Methods: A Canada-widepopulation based survey was conducted using standard random telephone polling. interviewers recruited household members who were at least 18 years of age. Participants were mailed a survey that included the Rome II questionnaire for functional gastrointestinal disorders, demographics, constipation symptoms and resource utilization. Data retrieval was completed by telephone. Results: Of the 1149 participants, 27.2% self-reported FC within the past 3 months and 38.6% within the last 12 months. Strictly following the published Rome II criteria, the prevalenceof FC was 0%. However, if patients who had loose, mushy or watery stools were not excluded, the Rome II prevalence of FC was 21%. With either definition, the prevalencein females was almost double that for males. Health care seeking (physician visits) occurred in 34% of subjects who serf-reported constipation and in 23.2% of Rome II defined subjects (p < 0.05). Increasing the number of required symptoms in the Rome II criteria for FC markedly decreased the prevalence of constipation (Rome 11:3/6symptoms = 13%; 4/6 = 7.0%; 5/6 = 2.6%) while the proportion of subjects reporting physician visits increased (24%, 35% and 46.7% respectively). Agreement between self-reported constipation and the various definitions of Rome II FC was very low (highest Kappa = .176, concordance = 54.5% with Rome II 2/6 symptoms). In those self-reporting FC in the past 12 months females

3215 Differences in Productivity, OOL, and Resource Use in Newly Diagnosed and Established Irritable Bowel Syndrome (IBS) Patients Priti Jhingran, Jean-Francois Ricci, Mike Markowitz, Susan H. Gordon, Afsaneh Asgbarian, Eric G. Carter, Glaxo Wellcome Inc, Research Triangle Park, NC Purpose: Several studies haveshown similar resource use of newly diagnosed and established IBS patients. However, little is known on the temporal impact of IBS on patients well being and workplace productivity and activity time, as patients learn to cope with IBS over time. Methods: Patients were screened in primary care and GI specialist practices for IBS according to the Rome II criteria. Positive screeners were evaluatedby their physicians for IBS. Confirmed

A-634