AG

AA

bst

ract

sSa1294

Predictors for Subsequent Need for Immunosuppressive Therapy in EarlyUlcerative ColtisCarsten Schmidt, Luisa Beltz, Bernd Bokemeyer, Dietrich Hueppe, Wolfgang Kruis,Susanna Nikolaus, Jan C. Preiss, Andreas Sturm, Niels Teich, Andreas Stallmach

Background and Aims: The clinical course of ulcerative colitis (UC) is highly variable witha subgroup of patients developing a progressive disease course necessitating immunosup-pressive therapy (IT). However, reliable, stable and non-invasive individual clinical para-meters in order to identify patients at risk for undergoing subsequent IT have not yet beensufficiently established. We therefore aimed to identify such clinical parameters. Methods:A retrospective, multicenter analysis of UC patients from 8 German tertiary IBD centers wasperformed. Patients were classified into two groups depending on requiring IT or not.Personal data, clinical and laboratory parameters during the first 3 months after initial UCdiagnosis as well as effects of initial medical therapy were compared between these twogroups. Results: In 104 (39.7%) of the 262 patients the UC course necessitated IT. Thosepatients were significantly more often hospitalized at the first flare of UC, suffered fromextraintestinal manifestations more often, had a greater extent of UC, required significantlymore often a systemic corticosteroid therapy and responded less well to this treatment.Furthermore, significant differences in serological markers of inflammation were observed.Age at diagnosis (OR 0.981 per year), gender (OR 1,33 for women), extent of the disease(OR 1,4-2,1 compared to proctitis), need for hospitalisation (OR 2,5) or steroid therapy atthe first flare (OR 2,4) and the effect of initial steroid therapy (OR 5,2 - 50,8 compared tono streoids) were used to develop a prognostic model predicting the individual probabilityof necessitating immunosuppressive therapy during the course of UC. This probability rangesfrom less than 2% up to 100% after 5 years, depending on the presence of individual riskfactors. Conclusions: The simple clinical items age at diagnosis, gender, extent of disease,need for hospitalisation or systemic steroid therapy at the first flare and effect of initialsteroid therapy can predict a progressive disease course in early UC. Our model based onthese parameters allows an individualized estimation of each patient's risk to develop aprogressive disease course. Thereby, our model can help in deciding if patients will needimmunosuppressive drugs early in the disease course or if immunosuppressive therapy canbe avoided.

Sa1295

Development of Process and Outcome Quality Indicators for InflammatoryBowel Disease (IBD)Gil Melmed, Corey A. Siegel, Brennan M. Spiegel, John I. Allen, Robert R. Cima, Jean-Frederic Colombel, Themistocles Dassopoulos, Lee Denson, Sharon Dudley-Brown, AndyGarb, Stephen B. Hanauer, Michael Kappelman, James D. Lewis, Isabelle Lynch, AmyMoynihan, David T. Rubin, Ryan B. Sartor, Ronald Schwartz, Douglas C. Wolf, ThomasA. Ullman

Introduction: Variations in adherence to management guidelines for IBD suggest variablequality of care. Quality indicators (QIs) can be developed to measure the structure, processesand outcomes of health care delivery; implementing these QIs may limit variations in careand ultimately improve quality of care. The RAND/UCLA appropriateness method, a widelyutilized, evidence-based, iterative approach used to establish QIs in several chronic illnesseswas utilized to develop a set of Process and Outcome QIs to define quality of care for IBD.Methods: Guidelines and position papers for IBD published from 2006-2011 were reviewedfor potential QIs. These were rated by a multidisciplinary panel comprised of representativesof the ACG, AGA, CCFA, and ECCO, with academic and private practice physicians, nurses,and patients. Potential Process and Outcome QIs were discussed at 3 moderated in-personmeetings, with pre- and post-meeting confidential electronic voting. Panelists rated thevalidity and feasibility of QIs on 1-9 scale; disagreement was assessed using a validatedindex. QIs rated >7 underwent literature review for evidence linking processes to an outcome,and the resulting 135-page compendium was distributed to panelists. QIs rated above 8were selected for the final set. Results: Over 600 potential Process QIs were extracted fromGuidelines. Following ratings and discussion by the first panel, 35 process QIs were selectedfor literature review in categories of diagnosis, treatment, drug safety, healthcare maintenance,surgery, and cancer prevention. After the second panel, 10 Process QIs were included inthe final set. Highly rated Process QIs included advocating avoidance of long-term steroidsby recommending steroid-sparing therapy or surgery, TB testing in those initiating anti-TNF therapy, testing for C difficile with flares, use of aminosalicylates in patients with mild-moderate colitis, and colectomy or reassessment of low grade dysplasia in UC. CandidateOutcome QIs were then derived from Process QIs, as well as from physician, nurse, andpatient input before a moderated third and final panel. Outcomes were rated in the categoriesof disease activity, health-related quality of life, healthcare utilization, and preventablecomplications. Highly rated Outcome QIs included steroid-free clinical remission, days lostfrom work/school, ER visits and hospitalization for IBD, and incontinence episodes. Noneof the top QIs exhibited disagreement. Conclusion: A set of QIs for IBD was developedwith expert interpretation of the literature, and multidisciplinary input. Outcome QIs focusedlargely on remission and quality of life while process QIs were aimed at therapeutic optimiza-tion and patient safety. Evaluation of these QIs in clinical practice is needed to assess thecorrelation of performance on process QIs with performance on outcome QIs.

Sa1296

Anal Ulceration in Crohn's Disease: Natural History at the Time of BiotherapyTimothee Wallenhorst, Guillaume Bouguen, Isabelle Berkelmans, Jean-François Bretagne,Laurent Siproudhis

Background: Anal ulcerations represent one of the characteristics of perianal Crohn's disease(CD), but their natural history is poorly understood. Using the largest published series ofanal ulcerations, the aim of this study was to clarify their outcomes at the time of biotherapy.Methods: Clinical features of 282 consecutive patients constituted a single-centered prospect-ive database of anal lesions of CD (from 01 /01/2007 to 08 /30/2011). The data for luminal

S-266AGA Abstracts

disease (Montreal classification, Harvey Bradshaw index), perianal disease (UFS classification,PDAI) and ongoing treatments were prospectively collected. The description of ulcerationsand their healing rates were analyzed. Results: A total of 154 patients (male =55, female =99; mean age 36 ± 16 years) had at least, one anal ulceration : it was one or more severeulcerations (U2) in 77 cases. Mean follow-up was 84 ± 86 weeks but 15 were examinedonce. The ulcerations were associated with suppuration (with surgical drainage) or analstenosis in 87 (57%) and 40 (26%) patients respectively. The treatment for CDwas infliximab,adalimumab, and azathioprine in 109 (71%), 44 (29%) and 111 (77%) patients respectively.The mean time to healing of ulcerations was 56±74 weeks: 45 (32%) patients did not healpermanently at the end of follow-up. New surgical drainage was performed in 37 (43%)patients but only 4 of 36 patients (11%) with initially non-fistulizing disease had suppurativecomplication de novo. Patients in whom anal ulcerations persisted, had, at follow-up, ahigher Harvey Bradshaw score (4 ± 21 vs. 2± 13) and a higher PDAI (6 ± 20 vs. 1 ± 10),but they had less surgical drainage and surgical reconstruction. Multivariate analysis showed,that the nature of the ulceration (U2) (but not therapeutic interventions: biotherapy, surgery)was associated with a lower chance of healing (OR 0.275, 95% CI: 0.09 to 0.85, p <0.05).Conclusion: Anal ulcerations of CD are associated with suppuration in more than half casesand suffered from a more severe disease activity on both luminal and anal locations. A thirdhas not healed after 18 months of follow-up (including U2). These findings call for trialsspecifically focused on the treatment of anal ulcerations.

Sa1297

The Relationship Between Perceived Psychological Support, Health-RelatedQuality of Life, and Disease Activity in Newly Diagnosed Inflammatory BowelDisease PatientsKristy L. Engel, Karla Helvie, Jeremy Adler, Ellen Zimmermann, Caitlyn M. Plonka, RieSuzuki

Individuals adjusting to the diagnosis of inflammatory bowel disease (IBD) encounter disease-related obstacles that can affect their physical, mental, and social health. Education andpsychological support can mitigate these negative effects. The purpose of the study was toexamine the relationship between patient's perceived psychological support, health-relatedquality of life, and disease activity. We tested the hypothesis that patients who are satisfiedwith their psychological support will report a higher health-related quality of life (HRQOL)and improved disease activity. Methods: Patients were at least fourteen years of age with anIBD diagnosis within three years. HRQOL was measured using the Short Form InflammatoryBowel Disease Questionnaire (SIBDQ). Patients' perceived psychological support was meas-ured using a modified Medical Outcomes Study-Social Support Survey (GI MOSS). Crohn'sdisease activity (HBI, PCDAI) and ulcerative colitis activity (SCCAI, PUCAI) were measured.The Spearman Rho correlation and logistical regression were used in data analysis. Results:Sixty-two patients completed the survey ranging in age from 17 to 72 years: 44% female;56% male. 37% had Crohn's disease (n=23), 59% ulcerative colitis (n=37), and 3% indeterm-inate colitis (n=2). Patient preferences for medical information were selected from a list ofoptions. Fifty-three percent of patients preferred receiving written information in bookletform, 50% preferred visiting disease specific websites, 40% preferred an IBD informationalpamphlet, 39% wanted the option of meeting with a health educator following diagnosis,and 39% wanted to be able to communicate directly with their gastroenterologist by email.Patients expressed receiving the emotional and psychological support they needed “Some-times” (29%), “Always” (27%), “Usually” (17%), “Rarely” (17%), and “Never” (10%). Patientshighlighted the lack of psychological support in their current treatment plans (82%). Finally,patients expressed a perceived benefit of counseling if it was provided (37%). There wasno relationship detected between the perceived psychological support (GI MOSS) and SIBDQ(R=0.20, p=0.12). Additionally, no relationship was present between psychological supportand disease activity with Crohn's disease patients (R= -0.31, p=.18) or ulcerative colitispatients (R= -0.12, p=.47). As expected SIBDQ strongly correlated with disease activity(ulcerative colitis: R= -0.76, p<.0001; Crohn's disease: R= -0.56, p=.0076). Conclusion:Newly diagnosed IBD patients crave information and psychological support. A variety ofmethods of communication are cited. Many patients lack emotional and psychological supportwhich is not part of most patient's treatment plan. Our study did not support a link betweenperceived psychological support and disease activity or health-related quality of life.

Sa1298

Telephone Encounters in Inflammatory Bowel Disease Patient ManagementMiguel Regueiro, Claudia M. Ramos Rivers, Anwar Dudekula, Linda Kontur, Eva Szigethy,Michael A. Dunn, Arthur Barrie, Marc Schwartz, Jason M. Swoger, Leonard Baidoo, DavidG. Binion

Introduction: Management of complex chronic diseases, including inflammatory bowel dis-ease (IBD; Crohn's disease, ulcerative colitis) requires regular office visits, occasional hospital-izations and frequent telephone communication between patients, health care providers andinsurers. The majority of telephone contact in healthcare is unreimbursed and will oftenrequire considerable effort on the part of nurses/support staff, in addition to physician time.There is limited data regarding the nature of telephone calls encountered in the managementof IBD, as well as the reasons for calls and the distribution of calls among patients. Methods:This study utilized the IBD center database at an academic referral center. Administrativedata on telephone calls received and performed by IBD nursing staff over a 2 year periodwas prospectively tabulated and categorized based on the nature of the call: problem/followup, resolution/plan, refill request, insurance authorization, completion of forms, recordrequest. Telephone encounters recorded in an electronic medical record over a 10 monthtime period in a consented IBD patient registry were analyzed, including patient diseasedemographics. Results: The number of telephone calls received/made by the IBD nursingstaff rose from 21,979 in 2009 to 32,667 in 2010 (p<0.0001). This corresponded with a26% rise in the IBD patient population seen during those years from 2475 to 3118. Themonthly call volume in 2009 was 1831, ranging from 1588 (January) to 2130 (December).In 2010, monthly call volume rose to 2722, ranging from 2077 (January) to 3297 (July).Over the two years 44% of telephone calls were problem/followup, 25% were resolution/plan, 12% were refill requests, 10% were insurance authorizations and the remaining were