- Email: [email protected]
Tu1095 Usefulness of the Ulcerative Colitis Endoscopic Index of Severity for Evaluating Endoscopic Activity of Ulcerative Colitis Patients Treated With Infliximab
AGA Abstracts
9,033 vs 5,293 ± 7,792 US dollar; p<0.001). From the multivariate analysis, age >85 years old, co-morbidity and sepsis were the risk factors of mortality during admission with adjusted odd ratio 2.40, 7.47 and 5.14, respectively. (Table) Conclusions: Although, the incidence of CDI is much lower in Thailand, than in Western countries, the current calculated burden of Thai CDI infection is high. The mortality rate depends on elderly age group and the co-morbidity, particularly sepsis. Thailand's health policy should improve the prevention strategies against CDI. Table Multivariate analysis of the risk factors predicting mortality in CDI patients
of a nurse led self management programme over a 5 year period. Method: The outcomes of the first 50 patients recruited into the programme in 2007/ 2008 where auditted. A database of patients was created and maintained over a 5 year period by a specialist nurse. Demographic data, diagnosis, colorectal cancer and osteoporosis surveillance, telephone helpline contacts, outpatient attendance (post-recruitment) and adverse events were evaluated. Patients were contacted annually by the nurse via telephone to reassess for signs of relapse. Patient satisfaction was evaluated by a questionnaire, Results: A cohort of 50 patients (36M: 14F) were studied. Median ages 45yrs (18-74yrs) were included. 32 patients had ulcerative colitis(UC) (16 pancolitis, 8 distal disease and 8 proctitis) and 18 Crohn's disease (CD) (9 terminal ileal disease, 9 Crohn's colitis.The median time of period of remission 36 months (8mths-10yrs). 10/50 (20%) of patients had a significant flare of their IBD (8 CD, 2 UC) and required them to exit the self-management programme due to disease progression. Median time to exit was 24 months (10-48). 2 required surgery, 6 progressed to immunomodulators and 2 to biologic therapy. Average clinic attendance for patients in remission (40 patients) was 1.9 hospital attendances within the five year period, with 2.9 appointments in primary care, all patients were treated with mesalazine and had annual blood tests. 26/ 33 patients with colitis required colorectal cancer surveillance, this was completed in 24/ 33 (92%) patients. All patients required a dexa scan in line with UK guidelines; this was completed in 75% of patients. Satisfaction with self-management remained high with 95% of patients scoring the method of follow up as good or excellent. Conclusion:- Therefore, self-management is a safe long term strategy for patients with IBD, but does require support from a specialist nurse to ensure colorectal cancer surveillance, osteoporosis screening completed and annual telephone review is made available. 1. Kennedy A P et al. A randomised controlled trial to assess the effectiveness and cost of a patient orientated self management approach to chronic inflammatory bowel disease. Gut. Nov 2004; 53(11): 1639-1645. 2. Robinson A et al. Guided self-management and patient-directed follow-up of ulcerative colitis: a randomised trial, The Lancet, Volume 358, Issue 9286, 22 September 2001, Pages 976-981.
CDI; Clostridium difficile infection
Tu1094 New Sitafloxacin Based Triple Therapy Is Effective in Third-Line Eradication Therapy for H. pylori Infection: A Multicenter Clinical Trial in Tokyo Metropolitan Area Shin'ichi Takahashi, Kengo Tokunaga, Masayoshi Ito, Shigeaki Mizuno, Akifumi Tanaka, Nobuhiro Sakaki Figure Proportion of CDI from overall colitis in each age group
Backgrounds: In Japan, the eradication rate of first-line therapy for Helicobacter pylori (H. pylori) infection with a proton pump inhibitor (PPI), amoxicillin (AMPC) and clarithromycin (CAM) for 1 week has been decreasing because of a high prevalence of CAM resistant strain. The eradication rate of the second-line therapy with a PPI, AMPC and metronidazole (MNZ) for 1 week is approximately 90 %. However, 2-3 % of patients still fail to respond to both first- and second-line therapies. Despite this condition there is currently no standard thirdline therapy in Japan. Materials and Methods: Subjects were 102 patients with H. pylori infection in whom the standard Japanese first and second line eradication therapies had proven unsuccessful at 15 facilities in the Tokyo metropolitan area in Japan from May 2011 to Oct 2014. Patients were assigned to one of the following third-line eradication therapies: (1) 10-days group; rabeprazole (RPZ) 10 mg 3 times a day (tid) +amoxicillin (AMPC)500 mg (tid) +sitafloxacin (STFX) 100 mg 2 times a day (bid) for 10 days. (2) 14-days group; same regimen for 14 days. H. pylori eradication was assessed by urea breath test. Results: Intention-to-treat (ITT) and per protocol (PP) analysis of third-line eradication rates were47/ 58(82.5%) in the 10-days group and 43/46(93.5%) in the 14-days group (p value = 0.085: Fishers exact test). The rates of adverse events were 12/58(20.7%) in the 10-days group and 19/46(41.3%) in the 14-days group. No patient stopped taking medications because of adverse events. Conclusions: Triple therapy with a regimen of RPZ, AMPC, and STFX would be an effective third-line eradication regimen for H. pylori in Japan. 10-days regimen of RPZ-AMPC-STFX may be safer compared with 14-days regimen.
Tu1092 The Impact of a Nurse Co-Ordinated IBD Multidisciplinary Team Meeting in Enhancing Safety and Reducing Cost Catherine J. Stansfield, Simon Lal, Robinson Andrew, Peter Paine Background: The management and medical therapy of inflammatory bowel disease (IBD) poses many challenges to clinicians. The U.K. IBD Standards have highlighted the need for a structured approach to the view of patients, but this can prove difficult as a result of limitations in outpatient capacity. Aims: To evaluate the impact of a multidisciplinary team (MDT) meeting coordinated by a nurse on clinical outcome and cost efficiencies. Methods: A one hour weekly MDT meeting was established to review all in-patients with IBD and those receiving biologic therapy. In addition, clinicians discussed cases that required additional opinions in management. This was attended by Consultant gastroenterologists, IBD Nurse Specialists, dieticians, junior medical staff and consultant surgeon. Outcomes from the meeting were recorded on a database and prospectively audited by an advanced nurse practitioner. Results: Within a six month period the IBD team met on 22 occasions. 257 patients were reviewed (120 male, 137 female median age 36 (16-77) with IBD (210 Crohn's disease, 39 ulcerative colitis and 3 pouchitis and 5 IBDU). Biological therapy was reviewed in 182 cases, including 136 patients requiring a routine annual review of therapy. Of the latter group, biological therapy was continued in 112/182 (61%) cases, based on continued disease activity. 18/182 (9%) patients were referred for further investigation to evaluate response to treatment and 6 were referred for outpatient clinic review. Clinical management was reviewed in 46 patients, and subsequently 18/46 patients had treatment de-escalated or ceased as a result of clinical improvement or mucosal healing. 8 patients with adverse events were reviewed and a further 8 patients had their biologic changed. 2 were referred for discussion at the medical surgical MDT. Endoscopy referrals were requested in 20 cases, MR scan in 7 cases and an urgent clinic appointment in 23 cases. A further 75 patients raised for general discussion regarding clinical management. Of these 10 were in-patients, and 3 were referred for surgical review, a further 7 had treatment progressed to anti-TNF therapy. 6 patients had endoscopic findings that required discussion. 30 patients were general discussion surrounding immunomodulating therapy. 7 patients had abnormal Liver function tests which required onward referral to hepatology. 22 patients had issues around general IBD management. Audit of compliance with NICE guidance improved from 80% to 100%. De-escalation of therapy and cessation of therapy accounted for a cost saving of £185,000 based upon reduction of drug use. Conclusion: The development of a nurse coordinated team meeting for IBD patients has facilitated a significant improvement in the overall quality of patient care, and has resulted in significant savings.
Tu1095 Usefulness of the Ulcerative Colitis Endoscopic Index of Severity for Evaluating Endoscopic Activity of Ulcerative Colitis Patients Treated With Infliximab Keiichiro Saigusa, Tadakazu Hisamatsu, Mari Arai, Hiroki Kiyohara, Shinya Sugimoto, Kiyoto Mori, Kozue Takeshita, Kosaku Nanki, Makoto Naganuma, Tatsuya Takeshita, Yoshihiro Nakazato, Tomoharu Yajima, Nagamu Inoue, Haruhiko Ogata, Yasushi Iwao, Takanori Kanai Background Ulcerative colitis (UC) is a type of chronic inflammatory bowel disease that is characterized by periods of remission and episodes of relapse. Mucosal healing is an emerging therapeutic target in UC, because it is associated with favorable outcomes. Various scoring systems have been used to assess mucosal healing in UC. The UC Endoscopic Index of Severity (UCEIS)—a newly developed scoring system—is the only validated endoscopic index at present, with a minimum interobserver variation in the overall assessment of severity. (Gastroenterology 2013; 145: 987-995) The UCEIS assesses the vascular pattern, bleeding, and erosions and ulcers, on a scale of 0 (remission) to 8 (severe). The correlation of the UCEIS and clinical outcomes of UC has not been examined. Aim In this study, we aimed to evaluate usefulness of the UCEIS in UC patients treated with infliximab (IFX). Methods The medical records of 124 patients, treated with IFX for UC at Keio university hospital, between October 2010 and May 2013, were reviewed retrospectively. Endoscopic findings were evaluated based on the UCEIS. Results The mean UCEIS score before IFX treatment was 4.9 (range, 2-8). Fifty-two patients underwent colonoscopy at 3-6 months after starting treatment with IFX; the mean post-therapeutic UCEIS score was 2.8, with a score of 0-1 in 17 patients (32.7%), 2-3 in 12 patients (23.1%), 4-5 in 19 patients (36.5%), and ≥6 in 4 patients (7.69%). Importantly, patients with a post-therapeutic UCEIS score of 0-1 had a significantly higher rate of medium-term event-free survival, defined as the lack of the need for either colectomy or any other induction therapy, compared with those with a UCEIS score ≥3 (p < 0.01, mean observation period 17.8 months). Multivariate analysis indicated that lack of vascular pattern after treatment was associated with unfavorable medium-term
Tu1093 5 Year Follow up of a Nurse Led Guided Self Management Programme in IBD Catherine J. Stansfield, Robinson Andrew, Simon Lal Background: Self management programmes are central to any long term strategy for managing chronic disease, the emphasis being to create expert patients who have the confidence, skills, information and knowledge to play a key role in their care and minimise the impact of the disease on their lives1. In addition, this has been shown to reduce attendance in outpatients and reliance upon the health care system2. Aim: To prospectively audit of patient outcomes
AGA Abstracts
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prognosis (p < 0.001). Conclusions The current study suggests that the UCEIS is a useful tool to evaluate endoscopic improvement in UC patients treated with IFX. A UCEIS score of 0 or 1 after treatment is associated with a favorable medium-term outcome; in particular, the severity of vascular pattern is strongly associated with the outcome. Thus, the UCEIS is a useful instrument for evaluating UC patients treated with IFX.
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Background and Aims: Upper gastrointestinal bleeding (UGIB) is a common clinical condition resulting in nearly 250,000 hospital admissions costing $2.5 billion per year in the United States. Patients presenting with low risk UGIB can be safely discharged home. However, prior research suggests patients hospitalized with UGIB are frequently low risk and that providers rarely use validated triage scores for clinical decision making. We sought to describe the frequency at which patients present to urban emergency departments (ED) with low risk UGIB and the proportion of these patients who are admitted to hospital to determine whether additional support tools would be useful in reducing healthcare utilization in this population. Methods: This is a retrospective cohort study of 2,183 patients presenting to the ED at three urban hospitals over a 5-year period (2009-2013). We used ICD-9 disposition diagnoses from the ED to identify patients with GI complaints compatible with UGIB followed by manual chart review for verification of UGIB and additional data collection. Patients were classified as low risk if their Glasgow Blatchford Score (GBS) was 0. Results: Over the study period, at the three sites with a combined more than 140,000 ED visits and average admission and observation rate of 23.7%, only 66 patients (13.2 per year) presented to the ED with UGIB and had a GBS of 0. Of these, 10 patients (15.2%) were admitted, with all admissions occurring when patients presented at night (p=0.019). Gastroenterology provided consultation on 6 of the 10 admitted patients (60.0%), all of whom underwent endoscopy. The most common endoscopic finding was gastritis (34%) and no patients required endoscopic hemostasis. Conclusions: Consistent with prior research, patients with UGIB with GBS of 0 do not require upper endoscopy for hemostasis. However, in contrast to previous studies, it is rare for low risk patients with UGIB to present to the ED. Only a minority of such patients are admitted, though this is significantly associated with presenting at night and may be a marker for inadequate follow-up. Despite the increasing advocacy for incorporating decision support tools into routine clinical care, there is little evidence to suggest that the magnitude of this problem is sufficiently large to warrant routine use of the GBS for ED management of UGIB.
Tu1096 Perceptions of Patient-Centered Care Among Veterans With Gastroesophageal Reflux Disease on Proton Pump Inhibitor Therapy Andrew J. Gawron, Salva Balbale, Scott A. Miskevics, Sherri L. LaVela Background. Limited data exist describing patient-centered care (PCC) outcomes among patients with gastroesophageal reflux disease (GERD) on proton pump inhibitor (PPI) therapy. The study purpose was to use a patient-reported outcome measure to explore perceptions of care among patients with GERD on PPI therapy. Methods. The Center for Evaluation of Practices and Experiences of Patient Centered Care (CEPEP) is a VA funded project to evaluate various PCC outcomes, using mailed validated surveys to Veterans with chronic conditions seen across 8 nationally representative VA centers. We analyzed the Patient Assessment of Care for Chronic Conditions (PACIC) in a subset of Veterans diagnosed with GERD and prescribed PPI therapy. The PACIC assesses patient views of the chronic care received and is organized into five subscales that address elements of patient-centered care as perceived by patients (Patient Activation, Delivery System Design/Decision Support, Goal Setting, Problem Solving/Contextual Counseling, and Follow-up/Coordination). Overall summary and subscale scores range from 1-5; higher scores indicate higher subjective ratings of health care received. We used descriptive statistics to describe patient characteristics and assess if PPI dosing (standard vs high dose) or duration of therapy (short term <6 mo vs long term >= 6 mo) was associated with perception of care received. Results. Veteran patients with GERD on PPI (n=501) were mostly male (94.6%), white/non-Hispanic (70.6%), and, on average, 68 years of age. 67.5% of respondents reported having 3 or more chronic conditions. Nearly all respondents (99.8%) reported having one or more recent outpatient visits; 24.8% reported one or more recent ER visits. 53.1% had high total daily dose initial PPI prescriptions; 46.9% had standard total daily dose initial prescriptions. A majority of respondents (87.6%) reported long-term PPI use. The mean PACIC summary score for the entire sample was 3.01 (SD=1.16). 39.0% of respondents achieved an overall PACIC summary score of 3.5 or higher. Respondents achieved highest scores overall in the Delivery System Design/Decision Support (3.36, SD=1.19) and Patient Activation subscales (3.23, SD=1.26); lowest scores were achieved in the Follow-up/Coordination subscale (2.56, SD=1.26) and the Goal Setting/Tailoring subscale (2.97, SD=1.27). Mean subscale score for Problem Solving/ Contextual Counseling was 3.21, SD=1.35. There were no differences in PACIC scores by PPI dose or duration of therapy. Conclusions. Veterans with GERD on PPI therapy were generally activated in their care and perceived care to be supportive in enhancing their own understanding of care. However, further efforts are needed to explore if PCC outcomes are associated with GERD symptom control, particularly in areas of follow-up support, tailored goal setting and coordination of care.
Tu1099 Impact of Bowel Preparation With Low-Volume (2-L) and Intermediate-Volume (3-L) Polyethylene Glycol on Colonoscopic Quality: A Prospective Observational Study Chi-Liang Cheng, Nai-Jen Liu, Yi-Ning Tsui, Cheng-Hui Lin, Ming-Yao Su, Cheng-Tang Chiu Background and Aims: Low-volume (2-L) polyethylene glycol (PEG) is the most commonly used bowel cleansing regimen in Taiwan, but its efficacy is unsatisfactory. The study aim was to compare 2-L and intermediate-volume (3-L) PEG regarding their impact on colonoscopic quality among an average-risk population aged from 40 to 75 years. Methods: 2-L PEG was provided between August 2012 and May 2013, while 3-L PEG was provided between June 2013 and March 2014. A Split-dose regimen was provided for morning colonoscopy, and a same-day regimen was provided for afternoon colonoscopy. The level of colon cleansing was prospectively scored with the Boston Bowel Preparation Scale (BBPS). Results: A total of 407 subjects completed the 2-L PEG regimen, and another 407 subjects completed the 3-L regimen. There was no difference in age, gender, or body mass index between the two groups. The bowel-cleansing efficacy was significantly improved in the 3L group (mean total BBPS score 7.80 vs. 7.08, respectively, P < 0.0001). The 3-L group had a significantly higher rate of excellent or good preparation, equivalent to a BBPS score ≥7, than the 2-L group (90% vs. 73%, respectively, P < 0.0001). Patient tolerability was significantly better in the 2-L group with regard to compliance, adverse events, and willingness to retake the regimen. More subjects in the 3-L preparation group compared with the 2-L group had overall adenoma (70.3% vs. 53.6%, respectively, P < 0.0001), proximal adenoma (47.4% vs. 35.4%, respectively, P = 0.0006), sessile serrated adenoma (27.5% vs. 6.1%, respectively, P < 0.0001), and advanced adenoma (20.9% vs. 9.3%, respectively, P < 0.0001). Conclusion: 3-L PEG provided better cleansing quality and higher adenoma detection but was less tolerable than 2-L.
Tu1097 Persistent Delays and Administrative Burden: Despite FDA Approval for Treatment of Crohn's Disease, Obtaining Vedolizumab Can Be Just As Difficult If Not More Than Ustekinumab Nicole Shen, Paul Christos, Ellen J. Scherl, Brian Bosworth Background: Vedolizumab (VDZ) and ustekinumab (USK) have been shown to be effective in treatment of Crohn's disease. In March 2014 VDZ was FDA approved for treatment of Crohn's disease, while USK is still in phase 3 clinical trials. Primary question: What effect does FDA approval status have on ability to obtain insurance prior authorization (PA), the length of approval, time to delivery of the first dose, and overall administrative burden. Methods: We performed a retrospective study in adults with anti-TNF refractory CD treated with USK or VDZ at an inflammatory bowel disease referral clinic between 6/2009 and 1/ 2014. Data collected included administrative burden required for drug approval (quantified by total number of faxes, telephone calls, or emails as documented in the electronic medical record), time from authorization request to approval and to first administration, CRP, and duration of therapy that the drug was approved for. Results: A total of 99 subjects were identified, 37 were prescribed USK and 62 VDZ. There were no statistically significant group characteristic differences between the two cohorts in regards to age, smoking status, or prior medications. Information regarding PA requirements for 3% (3/99) subjects was missing. Of the remaining 96 subjects, PA trended to be a more likely requirement for USK 77.1% (27/35) vs VDZ 62.3% (38/61) cohort (p=0.13). USK was more likely to be denied at first 48.1% (13/27) compared to 24.3% (9/37) of the VDZ group (p=0.05). Despite initial denial, most subjects obtained approval for USK and VDZ 90.6% and 90.2% respectively, and there was no difference regarding administrative burden with a median of 4 faxes, emails or phone calls per patient per drug attainment for both groups. USK was approved more rapidly than VDZ, with a median of 6.0 (0-252) vs 20.5 (2-132) days respectively (p=0.002). However there was no statistically significant difference in delay to medication administration from time of PA submission, median of 33 (0-424) and 43.5 (1-110) days for USK and VDZ respectively (p=0.85). USK was approved for a longer duration of therapy than VDZ, median 1 year (0.25-2) vs 0.5 years (0.25-1) respectively (p=0.004). Discussion: While FDA approval has shown a general trend in reduction of PA requirement and denial of those requiring PA for VDZ compared to USK, there are persistent significant delays in medication approval, medication administration and administrative burden equivalent to or worse than non-FDA approved USK, which may reflect FDA approval independent factors.
Tu1100 Suturing of Areas of Mucosal Defects Using Endoscopic Clips Accelerated Wound Healing After Colorectal Endoscopic Submucosal Dissection Hideaki Ritsuno, Taro Osada, Naoto Sakamoto, Takashi Murakami, Hiroya Ueyama, Kenshi Matsumoto, Tomoyoshi Shibuya, Akihito Nagahara, Tatsuo Ogihara, Sumio Watanabe Background and aims: Endoscopic submucosal dissection (ESD) allows en-bloc resection of superficial colorectal tumors regardless of size. However, as a result of ESD, large mucosal defects are made. Closure of the mucosal defect is presumed to reduce the risk of adverse events such as bleeding and perforation. We have designed a new closure device for large mucosal defects, named the "loop clip", which makes it easy to close any mucosal defect completely (Endoscopy. 2008;40 Suppl 2:E97-8). These endoscopic clips for closure of defects are effective for about one week, and most mucosal defects are completely repaired by one month after ESD (GIE 2013;78:793-8). We conducted a randomized controlled study to evaluate the efficacy of suturing in healing the defect compared with not suturing. Methods: This prospective study conducted from July 2010 to July 2014 included 28 patients who were randomly divided into two groups: sutured group (n=14) and not sutured group (n= 14). Mucosal defect areas were sutured using the "loop clip" and endoscopic clips. The size of the resected lesion was considered to be the size of the defect just after ESD. The defect at 4 weeks after ESD was directly determined by measuring the major and minor axes of the defect area using measure forceps. The mucosal defect area was defined as the submucosal area that was exposed or was not covered by a regenerating mucosal area. Reduction ratio
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Glasgow Blatchford Score of Limited Benefit in the Triage of Patients With Low Risk Upper Gastrointestinal Bleeding in the Emergency Department David A. Leiman, Angela M. Mills, Frances S. Shofer, Andrew Weber, James Lewis, Shivan J. Mehta
9,033 vs 5,293 ± 7,792 US dollar; p<0.001). From the multivariate analysis, age >85 years old, co-morbidity and sepsis were the risk factors of mortality during admission with adjusted odd ratio 2.40, 7.47 and 5.14, respectively. (Table) Conclusions: Although, the incidence of CDI is much lower in Thailand, than in Western countries, the current calculated burden of Thai CDI infection is high. The mortality rate depends on elderly age group and the co-morbidity, particularly sepsis. Thailand's health policy should improve the prevention strategies against CDI. Table Multivariate analysis of the risk factors predicting mortality in CDI patients
of a nurse led self management programme over a 5 year period. Method: The outcomes of the first 50 patients recruited into the programme in 2007/ 2008 where auditted. A database of patients was created and maintained over a 5 year period by a specialist nurse. Demographic data, diagnosis, colorectal cancer and osteoporosis surveillance, telephone helpline contacts, outpatient attendance (post-recruitment) and adverse events were evaluated. Patients were contacted annually by the nurse via telephone to reassess for signs of relapse. Patient satisfaction was evaluated by a questionnaire, Results: A cohort of 50 patients (36M: 14F) were studied. Median ages 45yrs (18-74yrs) were included. 32 patients had ulcerative colitis(UC) (16 pancolitis, 8 distal disease and 8 proctitis) and 18 Crohn's disease (CD) (9 terminal ileal disease, 9 Crohn's colitis.The median time of period of remission 36 months (8mths-10yrs). 10/50 (20%) of patients had a significant flare of their IBD (8 CD, 2 UC) and required them to exit the self-management programme due to disease progression. Median time to exit was 24 months (10-48). 2 required surgery, 6 progressed to immunomodulators and 2 to biologic therapy. Average clinic attendance for patients in remission (40 patients) was 1.9 hospital attendances within the five year period, with 2.9 appointments in primary care, all patients were treated with mesalazine and had annual blood tests. 26/ 33 patients with colitis required colorectal cancer surveillance, this was completed in 24/ 33 (92%) patients. All patients required a dexa scan in line with UK guidelines; this was completed in 75% of patients. Satisfaction with self-management remained high with 95% of patients scoring the method of follow up as good or excellent. Conclusion:- Therefore, self-management is a safe long term strategy for patients with IBD, but does require support from a specialist nurse to ensure colorectal cancer surveillance, osteoporosis screening completed and annual telephone review is made available. 1. Kennedy A P et al. A randomised controlled trial to assess the effectiveness and cost of a patient orientated self management approach to chronic inflammatory bowel disease. Gut. Nov 2004; 53(11): 1639-1645. 2. Robinson A et al. Guided self-management and patient-directed follow-up of ulcerative colitis: a randomised trial, The Lancet, Volume 358, Issue 9286, 22 September 2001, Pages 976-981.
CDI; Clostridium difficile infection
Tu1094 New Sitafloxacin Based Triple Therapy Is Effective in Third-Line Eradication Therapy for H. pylori Infection: A Multicenter Clinical Trial in Tokyo Metropolitan Area Shin'ichi Takahashi, Kengo Tokunaga, Masayoshi Ito, Shigeaki Mizuno, Akifumi Tanaka, Nobuhiro Sakaki Figure Proportion of CDI from overall colitis in each age group
Backgrounds: In Japan, the eradication rate of first-line therapy for Helicobacter pylori (H. pylori) infection with a proton pump inhibitor (PPI), amoxicillin (AMPC) and clarithromycin (CAM) for 1 week has been decreasing because of a high prevalence of CAM resistant strain. The eradication rate of the second-line therapy with a PPI, AMPC and metronidazole (MNZ) for 1 week is approximately 90 %. However, 2-3 % of patients still fail to respond to both first- and second-line therapies. Despite this condition there is currently no standard thirdline therapy in Japan. Materials and Methods: Subjects were 102 patients with H. pylori infection in whom the standard Japanese first and second line eradication therapies had proven unsuccessful at 15 facilities in the Tokyo metropolitan area in Japan from May 2011 to Oct 2014. Patients were assigned to one of the following third-line eradication therapies: (1) 10-days group; rabeprazole (RPZ) 10 mg 3 times a day (tid) +amoxicillin (AMPC)500 mg (tid) +sitafloxacin (STFX) 100 mg 2 times a day (bid) for 10 days. (2) 14-days group; same regimen for 14 days. H. pylori eradication was assessed by urea breath test. Results: Intention-to-treat (ITT) and per protocol (PP) analysis of third-line eradication rates were47/ 58(82.5%) in the 10-days group and 43/46(93.5%) in the 14-days group (p value = 0.085: Fishers exact test). The rates of adverse events were 12/58(20.7%) in the 10-days group and 19/46(41.3%) in the 14-days group. No patient stopped taking medications because of adverse events. Conclusions: Triple therapy with a regimen of RPZ, AMPC, and STFX would be an effective third-line eradication regimen for H. pylori in Japan. 10-days regimen of RPZ-AMPC-STFX may be safer compared with 14-days regimen.
Tu1092 The Impact of a Nurse Co-Ordinated IBD Multidisciplinary Team Meeting in Enhancing Safety and Reducing Cost Catherine J. Stansfield, Simon Lal, Robinson Andrew, Peter Paine Background: The management and medical therapy of inflammatory bowel disease (IBD) poses many challenges to clinicians. The U.K. IBD Standards have highlighted the need for a structured approach to the view of patients, but this can prove difficult as a result of limitations in outpatient capacity. Aims: To evaluate the impact of a multidisciplinary team (MDT) meeting coordinated by a nurse on clinical outcome and cost efficiencies. Methods: A one hour weekly MDT meeting was established to review all in-patients with IBD and those receiving biologic therapy. In addition, clinicians discussed cases that required additional opinions in management. This was attended by Consultant gastroenterologists, IBD Nurse Specialists, dieticians, junior medical staff and consultant surgeon. Outcomes from the meeting were recorded on a database and prospectively audited by an advanced nurse practitioner. Results: Within a six month period the IBD team met on 22 occasions. 257 patients were reviewed (120 male, 137 female median age 36 (16-77) with IBD (210 Crohn's disease, 39 ulcerative colitis and 3 pouchitis and 5 IBDU). Biological therapy was reviewed in 182 cases, including 136 patients requiring a routine annual review of therapy. Of the latter group, biological therapy was continued in 112/182 (61%) cases, based on continued disease activity. 18/182 (9%) patients were referred for further investigation to evaluate response to treatment and 6 were referred for outpatient clinic review. Clinical management was reviewed in 46 patients, and subsequently 18/46 patients had treatment de-escalated or ceased as a result of clinical improvement or mucosal healing. 8 patients with adverse events were reviewed and a further 8 patients had their biologic changed. 2 were referred for discussion at the medical surgical MDT. Endoscopy referrals were requested in 20 cases, MR scan in 7 cases and an urgent clinic appointment in 23 cases. A further 75 patients raised for general discussion regarding clinical management. Of these 10 were in-patients, and 3 were referred for surgical review, a further 7 had treatment progressed to anti-TNF therapy. 6 patients had endoscopic findings that required discussion. 30 patients were general discussion surrounding immunomodulating therapy. 7 patients had abnormal Liver function tests which required onward referral to hepatology. 22 patients had issues around general IBD management. Audit of compliance with NICE guidance improved from 80% to 100%. De-escalation of therapy and cessation of therapy accounted for a cost saving of £185,000 based upon reduction of drug use. Conclusion: The development of a nurse coordinated team meeting for IBD patients has facilitated a significant improvement in the overall quality of patient care, and has resulted in significant savings.
Tu1095 Usefulness of the Ulcerative Colitis Endoscopic Index of Severity for Evaluating Endoscopic Activity of Ulcerative Colitis Patients Treated With Infliximab Keiichiro Saigusa, Tadakazu Hisamatsu, Mari Arai, Hiroki Kiyohara, Shinya Sugimoto, Kiyoto Mori, Kozue Takeshita, Kosaku Nanki, Makoto Naganuma, Tatsuya Takeshita, Yoshihiro Nakazato, Tomoharu Yajima, Nagamu Inoue, Haruhiko Ogata, Yasushi Iwao, Takanori Kanai Background Ulcerative colitis (UC) is a type of chronic inflammatory bowel disease that is characterized by periods of remission and episodes of relapse. Mucosal healing is an emerging therapeutic target in UC, because it is associated with favorable outcomes. Various scoring systems have been used to assess mucosal healing in UC. The UC Endoscopic Index of Severity (UCEIS)—a newly developed scoring system—is the only validated endoscopic index at present, with a minimum interobserver variation in the overall assessment of severity. (Gastroenterology 2013; 145: 987-995) The UCEIS assesses the vascular pattern, bleeding, and erosions and ulcers, on a scale of 0 (remission) to 8 (severe). The correlation of the UCEIS and clinical outcomes of UC has not been examined. Aim In this study, we aimed to evaluate usefulness of the UCEIS in UC patients treated with infliximab (IFX). Methods The medical records of 124 patients, treated with IFX for UC at Keio university hospital, between October 2010 and May 2013, were reviewed retrospectively. Endoscopic findings were evaluated based on the UCEIS. Results The mean UCEIS score before IFX treatment was 4.9 (range, 2-8). Fifty-two patients underwent colonoscopy at 3-6 months after starting treatment with IFX; the mean post-therapeutic UCEIS score was 2.8, with a score of 0-1 in 17 patients (32.7%), 2-3 in 12 patients (23.1%), 4-5 in 19 patients (36.5%), and ≥6 in 4 patients (7.69%). Importantly, patients with a post-therapeutic UCEIS score of 0-1 had a significantly higher rate of medium-term event-free survival, defined as the lack of the need for either colectomy or any other induction therapy, compared with those with a UCEIS score ≥3 (p < 0.01, mean observation period 17.8 months). Multivariate analysis indicated that lack of vascular pattern after treatment was associated with unfavorable medium-term
Tu1093 5 Year Follow up of a Nurse Led Guided Self Management Programme in IBD Catherine J. Stansfield, Robinson Andrew, Simon Lal Background: Self management programmes are central to any long term strategy for managing chronic disease, the emphasis being to create expert patients who have the confidence, skills, information and knowledge to play a key role in their care and minimise the impact of the disease on their lives1. In addition, this has been shown to reduce attendance in outpatients and reliance upon the health care system2. Aim: To prospectively audit of patient outcomes
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prognosis (p < 0.001). Conclusions The current study suggests that the UCEIS is a useful tool to evaluate endoscopic improvement in UC patients treated with IFX. A UCEIS score of 0 or 1 after treatment is associated with a favorable medium-term outcome; in particular, the severity of vascular pattern is strongly associated with the outcome. Thus, the UCEIS is a useful instrument for evaluating UC patients treated with IFX.
Tu1098
Background and Aims: Upper gastrointestinal bleeding (UGIB) is a common clinical condition resulting in nearly 250,000 hospital admissions costing $2.5 billion per year in the United States. Patients presenting with low risk UGIB can be safely discharged home. However, prior research suggests patients hospitalized with UGIB are frequently low risk and that providers rarely use validated triage scores for clinical decision making. We sought to describe the frequency at which patients present to urban emergency departments (ED) with low risk UGIB and the proportion of these patients who are admitted to hospital to determine whether additional support tools would be useful in reducing healthcare utilization in this population. Methods: This is a retrospective cohort study of 2,183 patients presenting to the ED at three urban hospitals over a 5-year period (2009-2013). We used ICD-9 disposition diagnoses from the ED to identify patients with GI complaints compatible with UGIB followed by manual chart review for verification of UGIB and additional data collection. Patients were classified as low risk if their Glasgow Blatchford Score (GBS) was 0. Results: Over the study period, at the three sites with a combined more than 140,000 ED visits and average admission and observation rate of 23.7%, only 66 patients (13.2 per year) presented to the ED with UGIB and had a GBS of 0. Of these, 10 patients (15.2%) were admitted, with all admissions occurring when patients presented at night (p=0.019). Gastroenterology provided consultation on 6 of the 10 admitted patients (60.0%), all of whom underwent endoscopy. The most common endoscopic finding was gastritis (34%) and no patients required endoscopic hemostasis. Conclusions: Consistent with prior research, patients with UGIB with GBS of 0 do not require upper endoscopy for hemostasis. However, in contrast to previous studies, it is rare for low risk patients with UGIB to present to the ED. Only a minority of such patients are admitted, though this is significantly associated with presenting at night and may be a marker for inadequate follow-up. Despite the increasing advocacy for incorporating decision support tools into routine clinical care, there is little evidence to suggest that the magnitude of this problem is sufficiently large to warrant routine use of the GBS for ED management of UGIB.
Tu1096 Perceptions of Patient-Centered Care Among Veterans With Gastroesophageal Reflux Disease on Proton Pump Inhibitor Therapy Andrew J. Gawron, Salva Balbale, Scott A. Miskevics, Sherri L. LaVela Background. Limited data exist describing patient-centered care (PCC) outcomes among patients with gastroesophageal reflux disease (GERD) on proton pump inhibitor (PPI) therapy. The study purpose was to use a patient-reported outcome measure to explore perceptions of care among patients with GERD on PPI therapy. Methods. The Center for Evaluation of Practices and Experiences of Patient Centered Care (CEPEP) is a VA funded project to evaluate various PCC outcomes, using mailed validated surveys to Veterans with chronic conditions seen across 8 nationally representative VA centers. We analyzed the Patient Assessment of Care for Chronic Conditions (PACIC) in a subset of Veterans diagnosed with GERD and prescribed PPI therapy. The PACIC assesses patient views of the chronic care received and is organized into five subscales that address elements of patient-centered care as perceived by patients (Patient Activation, Delivery System Design/Decision Support, Goal Setting, Problem Solving/Contextual Counseling, and Follow-up/Coordination). Overall summary and subscale scores range from 1-5; higher scores indicate higher subjective ratings of health care received. We used descriptive statistics to describe patient characteristics and assess if PPI dosing (standard vs high dose) or duration of therapy (short term <6 mo vs long term >= 6 mo) was associated with perception of care received. Results. Veteran patients with GERD on PPI (n=501) were mostly male (94.6%), white/non-Hispanic (70.6%), and, on average, 68 years of age. 67.5% of respondents reported having 3 or more chronic conditions. Nearly all respondents (99.8%) reported having one or more recent outpatient visits; 24.8% reported one or more recent ER visits. 53.1% had high total daily dose initial PPI prescriptions; 46.9% had standard total daily dose initial prescriptions. A majority of respondents (87.6%) reported long-term PPI use. The mean PACIC summary score for the entire sample was 3.01 (SD=1.16). 39.0% of respondents achieved an overall PACIC summary score of 3.5 or higher. Respondents achieved highest scores overall in the Delivery System Design/Decision Support (3.36, SD=1.19) and Patient Activation subscales (3.23, SD=1.26); lowest scores were achieved in the Follow-up/Coordination subscale (2.56, SD=1.26) and the Goal Setting/Tailoring subscale (2.97, SD=1.27). Mean subscale score for Problem Solving/ Contextual Counseling was 3.21, SD=1.35. There were no differences in PACIC scores by PPI dose or duration of therapy. Conclusions. Veterans with GERD on PPI therapy were generally activated in their care and perceived care to be supportive in enhancing their own understanding of care. However, further efforts are needed to explore if PCC outcomes are associated with GERD symptom control, particularly in areas of follow-up support, tailored goal setting and coordination of care.
Tu1099 Impact of Bowel Preparation With Low-Volume (2-L) and Intermediate-Volume (3-L) Polyethylene Glycol on Colonoscopic Quality: A Prospective Observational Study Chi-Liang Cheng, Nai-Jen Liu, Yi-Ning Tsui, Cheng-Hui Lin, Ming-Yao Su, Cheng-Tang Chiu Background and Aims: Low-volume (2-L) polyethylene glycol (PEG) is the most commonly used bowel cleansing regimen in Taiwan, but its efficacy is unsatisfactory. The study aim was to compare 2-L and intermediate-volume (3-L) PEG regarding their impact on colonoscopic quality among an average-risk population aged from 40 to 75 years. Methods: 2-L PEG was provided between August 2012 and May 2013, while 3-L PEG was provided between June 2013 and March 2014. A Split-dose regimen was provided for morning colonoscopy, and a same-day regimen was provided for afternoon colonoscopy. The level of colon cleansing was prospectively scored with the Boston Bowel Preparation Scale (BBPS). Results: A total of 407 subjects completed the 2-L PEG regimen, and another 407 subjects completed the 3-L regimen. There was no difference in age, gender, or body mass index between the two groups. The bowel-cleansing efficacy was significantly improved in the 3L group (mean total BBPS score 7.80 vs. 7.08, respectively, P < 0.0001). The 3-L group had a significantly higher rate of excellent or good preparation, equivalent to a BBPS score ≥7, than the 2-L group (90% vs. 73%, respectively, P < 0.0001). Patient tolerability was significantly better in the 2-L group with regard to compliance, adverse events, and willingness to retake the regimen. More subjects in the 3-L preparation group compared with the 2-L group had overall adenoma (70.3% vs. 53.6%, respectively, P < 0.0001), proximal adenoma (47.4% vs. 35.4%, respectively, P = 0.0006), sessile serrated adenoma (27.5% vs. 6.1%, respectively, P < 0.0001), and advanced adenoma (20.9% vs. 9.3%, respectively, P < 0.0001). Conclusion: 3-L PEG provided better cleansing quality and higher adenoma detection but was less tolerable than 2-L.
Tu1097 Persistent Delays and Administrative Burden: Despite FDA Approval for Treatment of Crohn's Disease, Obtaining Vedolizumab Can Be Just As Difficult If Not More Than Ustekinumab Nicole Shen, Paul Christos, Ellen J. Scherl, Brian Bosworth Background: Vedolizumab (VDZ) and ustekinumab (USK) have been shown to be effective in treatment of Crohn's disease. In March 2014 VDZ was FDA approved for treatment of Crohn's disease, while USK is still in phase 3 clinical trials. Primary question: What effect does FDA approval status have on ability to obtain insurance prior authorization (PA), the length of approval, time to delivery of the first dose, and overall administrative burden. Methods: We performed a retrospective study in adults with anti-TNF refractory CD treated with USK or VDZ at an inflammatory bowel disease referral clinic between 6/2009 and 1/ 2014. Data collected included administrative burden required for drug approval (quantified by total number of faxes, telephone calls, or emails as documented in the electronic medical record), time from authorization request to approval and to first administration, CRP, and duration of therapy that the drug was approved for. Results: A total of 99 subjects were identified, 37 were prescribed USK and 62 VDZ. There were no statistically significant group characteristic differences between the two cohorts in regards to age, smoking status, or prior medications. Information regarding PA requirements for 3% (3/99) subjects was missing. Of the remaining 96 subjects, PA trended to be a more likely requirement for USK 77.1% (27/35) vs VDZ 62.3% (38/61) cohort (p=0.13). USK was more likely to be denied at first 48.1% (13/27) compared to 24.3% (9/37) of the VDZ group (p=0.05). Despite initial denial, most subjects obtained approval for USK and VDZ 90.6% and 90.2% respectively, and there was no difference regarding administrative burden with a median of 4 faxes, emails or phone calls per patient per drug attainment for both groups. USK was approved more rapidly than VDZ, with a median of 6.0 (0-252) vs 20.5 (2-132) days respectively (p=0.002). However there was no statistically significant difference in delay to medication administration from time of PA submission, median of 33 (0-424) and 43.5 (1-110) days for USK and VDZ respectively (p=0.85). USK was approved for a longer duration of therapy than VDZ, median 1 year (0.25-2) vs 0.5 years (0.25-1) respectively (p=0.004). Discussion: While FDA approval has shown a general trend in reduction of PA requirement and denial of those requiring PA for VDZ compared to USK, there are persistent significant delays in medication approval, medication administration and administrative burden equivalent to or worse than non-FDA approved USK, which may reflect FDA approval independent factors.
Tu1100 Suturing of Areas of Mucosal Defects Using Endoscopic Clips Accelerated Wound Healing After Colorectal Endoscopic Submucosal Dissection Hideaki Ritsuno, Taro Osada, Naoto Sakamoto, Takashi Murakami, Hiroya Ueyama, Kenshi Matsumoto, Tomoyoshi Shibuya, Akihito Nagahara, Tatsuo Ogihara, Sumio Watanabe Background and aims: Endoscopic submucosal dissection (ESD) allows en-bloc resection of superficial colorectal tumors regardless of size. However, as a result of ESD, large mucosal defects are made. Closure of the mucosal defect is presumed to reduce the risk of adverse events such as bleeding and perforation. We have designed a new closure device for large mucosal defects, named the "loop clip", which makes it easy to close any mucosal defect completely (Endoscopy. 2008;40 Suppl 2:E97-8). These endoscopic clips for closure of defects are effective for about one week, and most mucosal defects are completely repaired by one month after ESD (GIE 2013;78:793-8). We conducted a randomized controlled study to evaluate the efficacy of suturing in healing the defect compared with not suturing. Methods: This prospective study conducted from July 2010 to July 2014 included 28 patients who were randomly divided into two groups: sutured group (n=14) and not sutured group (n= 14). Mucosal defect areas were sutured using the "loop clip" and endoscopic clips. The size of the resected lesion was considered to be the size of the defect just after ESD. The defect at 4 weeks after ESD was directly determined by measuring the major and minor axes of the defect area using measure forceps. The mucosal defect area was defined as the submucosal area that was exposed or was not covered by a regenerating mucosal area. Reduction ratio
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AGA Abstracts
AGA Abstracts
Glasgow Blatchford Score of Limited Benefit in the Triage of Patients With Low Risk Upper Gastrointestinal Bleeding in the Emergency Department David A. Leiman, Angela M. Mills, Frances S. Shofer, Andrew Weber, James Lewis, Shivan J. Mehta