- Email: [email protected]
Su1017 Comparative Short and Long-Term Efficacy of Infliximab and Adalimumab in Patients With Ulcerative Colitis Refractory to Corticosteroids: A Retrospective Study
AGA Abstracts
to decide the most suitable biologic medication to treat their disease. The most important considerations in choosing SEB treatment for patients were safety, efficacy, and that both the originator and biosimilar have identical review and approval processes. 96% of respondents were concerned about limited medication choice during induction and/or maintenance therapy. Conclusions IBD patients who responded to our survey were quite familiar with SEBs, although they expressed high concerns around safety, efficacy, and regulatory process. The patient choice directive is very strong and shows the need for open dialogue among patients, physicians, manufacturers, and regulatory bodies for the safe introduction of SEBs into the marketplace.
Su1015 The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Use in the Clinical Setting Hannes Holz, Natasha A. Koloski, Michael P. Jones, Marguerite DeBarros, Daniel Burger, Neal Martin, Johann Hammer, Moritz T. von Wulffen, Nicholas J. Talley, Gerald Holtmann Background: The lack of an instrument for the assessment of the severity and impact of gastrointestinal symptoms in the clinical setting prompted the development of the Structured Assessment of Gastrointestinal Symptoms (SAGIS) Instrument. We aimed to determine the reliability and validity of the SAGIS in the clinical setting. Methods: 45 patients with a variety of gastrointestinal problems referred for assessment and treatment at a large tertiary hospital were given the SAGIS prior to their consultation. The SAGIS includes questions on the severity of 23 upper and lower gastrointestinal symptoms over the past week. Responses are given on a 5 point likert scale that includes no problem, mild, moderate, severe and very severe problem. Patients also completed the validated Rome III questions for irritable bowel syndrome (IBS) and functional dyspepsia (FD), IBS Symptom Severity Scale (IBS-SSS) and the Hospital Anxiety and Depression Scale (HADS). A group of 194 patients were also given the SAGIS to complete again 1 week later to assess the test re test reliability of the measure. Results: Convergent validity was established by correlations between the individual scales of five SAGIS domains ( 1.)Epigastric Pain, 2.) IBS-D, 3.) Acid regurgitation, 4.) Nausea/Vomiting, 5.) Constipation) and the individual scales of the IBS-SSS and the HADS. Four of five SAGIS domains correlate well with the IBS-SSS (Pearson Correlation: 1.) 0.683, 2.) 0.500, 3.) 0.551, 4.) 0.474, 5.) 0.153) but none with either anxiety or depression from the HADS. Discriminant validity was assessed by correlations between the five SAGIS domains and the Rome III criteria for individuals who have IBS and FD versus do not meet criteria for these conditions. The results are supportive both in terms of where there is clear discrimination but also in terms of where there is not. For example, the IBS-D domain does clearly differentiate IBS from non-IBS but the epigastric pain domain does not, as one would expect (Wilcoxon-Mann-Whitney-Test: IBS-D 0.001, epigastric pain 0.07). The reverse is true when discriminating FD from non-FD, again as would be expected (Wilcoxon-Mann-Whitney-Test: IBS-D 0.5, epigastric pain 0.02).When n=194 patients were given the SAGIS and then retested 1 week later their paired scores for the five SAGIS domains did not change significantly with a maximum change of 12% from baseline and were well correlated ( 1.) 0.716, 2.) 0.615, 3.) 0.548, 4.) 0.634 5.) 0.660). The results indicate ordinal agreement between occasions. All Cohen's d values are well inside the small range (<0.4) (d values: 1.) 0.18, 2.) 0.11, 3.) 0.00, 4.) 0.04, 5.) 0.10). Overall the data support excellent test-retest reliability. Conclusions: The SAGIS is a reliable and valid measure that is suitable to assess severity and impact of GI symptoms in the clinical setting.
Su1013 Case-Control Analysis of Risk Factors for Poor Bowel Preparations in Outpatient Cohorts Marguerite DeBarros, Luke F. Hourigan, Natasha A. Koloski, Graeme Rich, Amanda Whaley, Louise Young, Nicholas J. Talley, Belinda Johnson, Gerald Holtmann Background: The quality of bowel preparation is a key determinant for the overall quality of colonoscopies since the polyp detection rate is adversely affected in patients with poor bowel preparation. In addition, poor bowel preparation can be costly since this may require repeat procedures. So far, quality improvement studies have aimed to improve the bowel prep regimen by modifying the regimen (e.g. split-prep versus single dose), the ingredients (e.g. PEG vs Sodium Phosphate Solution) or to identify risk factors such as underlying metabolic disorders. However, it may well be that other factors such as compliance or language barriers are critical for the quality of the bowel preparation. Methods: As part of our routine quality improvement program, we conducted a case-control study to identify risk factors associated with poor bowel preparation. In a standardised fashion, the quality of bowel preparations was assessed in all patients and those with poor bowel preparation identified. Prior to the procedure, all patients underwent standardised bowel preparation education and received split-preparation product free of charge. All patients with poor bowel preparation were matched by two patients with good bowel preparation from the same procedure list to minimise effects of inter-rater variability. For all patients and controls, comorbidities and socio-demographic background (as determined by postcode of primary residency) were assessed. Univariate (Chi-square) and logistic regression were used to quantitate. Results: Out of 434 consecutive colonoscopies during a two month period 22 were found to have a poor bowel preparation. Univariate analysis revealed that residence in a region with lower socio-economic background was a risk factor for poor bowel prep (RR 3.4, 95% CI 1.18-10.0). Age, sex, employment status, comorbidities or the need to use an interpreter were not associated with the quality of bowel prep. Conclusion: Our data demonstrates a link between socio-demographic factors and the quality of bowel preparations. It might be speculated that this is mediated via apprehension and compliance with the instructions for the bowel preparation. Our findings suggest targeted measures to improve the quality of bowel preparation in these groups.
Su1016 Fecal Immunochemical Test Versus Fecal Calprotectin for the Predictive Ability of the Prognosis of Ulcerative Colitis Asuka Nakarai, Sakiko Hiraoka, Jun Kato, Toshihiro Inokuchi, Shiho Takashima, Daisuke Takei, Yuusaku Sugihara, Masahiro Takahara, Keita Harada, Hiroyuki Okada
Su1014 Evidence of Content Validity and Psychometric Properties of Sf-36 for Measuring Health-Related Quality of Life of Patients With Crohn's Disease Aaron Yarlas, Michelle White, Mike Ingham, Chenglong Han
Abstract body Background: We previously reported that ulcerative colitis (UC) patients in clinical remission with Mayo endoscopic subscore (MES) 0 showed lower risk of relapse relative to those with MES 1-3, and a quantitative fecal immunochemical test (FIT) could be useful for evaluating relapse risk (DDW 2015). On the other hand, fecal calprotectin (Fcal) has also been reported as an important predictive factor of UC prognosis. The aim of this study was to compare the predictive ability of these two fecal markers for the clinical prognosis in UC. Methods: We prospectively observed the clinical prognosis of UC patients in clinical remission with MES 0, based on FIT and Fcal results. Results: In total, 87 UC patients in clinical remission with MES 0 were eligible to this study (46 male; median age 47 years). Their one-year relapse rate was 16%. We divided 87 patients into two groups according to the each median of FIT and Fcal results (the media of FIT; 50 ng/ml, Fcal; 65 µg/g), and compared the clinical prognosis of both groups. While the positive FIT result group (FIT > 50 ng/ml) showed statistically significantly higher risk of relapse relative to the negative FIT result group (FIT % 50 ng/ml) (Hazard ratio (HR) = 3.36; 95% confidence interval (CI), 1.98-8.60), there was no difference of clinical prognosis between the positive (Fcal > 65µg/g) and negative (Fcal % 65µg/g) Fcal result group (HR of relapse = 1.10; 95% CI, 0.47-2.65). Conclusions: FIT could predict the clinical prognosis of UC patients in clinical remission with MES 0. In contrast, Fcal could not predict in this study.
Objective: A literature review and cognitive debriefing interviews were conducted to assess the adequacy of evidence for the SF-36® Health Survey (SF-36) as a valid and reliable instrument for measuring Health Related quality of life (HRQOL) in patients with Crohn's disease (CD) in clinical trials. Methods: A literature search of several medical databases (eg Medline, Ovid) used search terms for variations of "SF-36" and "Crohn's disease" in the title or abstract of English language publications within the past 20 years. Among 327 identified abstracts, 76 full-text articles were reviewed, of which 34 articles were selected for data extraction based on appropriateness of content. Evidence of content validity and psychometric properties was evaluated based on the criteria specified in the FDA Guidance for Industry, "Patient-Reported Outcome Measures: Use in Medicinal Product Development to Support Labeling Claims." In addition, a cognitive debriefing study of the SF-36 was conducted via qualitative interviews with 16 patients with moderate-to-severe CD. Results: Concept elicitation studies supported content validity, where concepts reported by patients on the impact of CD on their daily functioning and well-being were well aligned with concepts measured by the SF-36 and were not redundant with disease-specific measures in HRQOL in CD. Cognitive debriefing interviews confirmed the relevance and comprehensiveness of all concepts covered by SF-36, as well as appropriateness of the instructions, response scales, and recall period. Evidence showed that SF-36 scores for patients with CD were consistently lower than normative scores from the general population and similar to patients with other chronic conditions such as diabetes and asthma. The literature supported the ability of SF36 scales and summary scores to detect clinically meaningful change in HRQOL in patients with CD receiving effective treatment. Convergent and discriminant validity were demonstrated by the evidence that SF-36 scores highly correlated with scores of other HRQOL measures in patients with CD and clinically meaningful differences were found on all SF36 scales when comparing patients with CD across levels of disease activity. Reported findings from samples of patients with CD included evidence for good internal consistency reliability (Cronbach's alphas ranging from 0.72 to 0.90) and good test-retest reliability (intraclass correlation coefficients ranging from 0.72 to 0.89) for all eight SF-36 scales. Conclusion: The comprehensive literature review and cognitive debriefing study demonstrated evidence for content validity and strong psychometric properties of SF-36 when used in patients with CD across different disease activities.
AGA Abstracts
Su1017 Comparative Short and Long-Term Efficacy of Infliximab and Adalimumab in Patients With Ulcerative Colitis Refractory to Corticosteroids: A Retrospective Study Naoki Yoshimura, Minako Sako, Masakazu Takazoe Background: Currently, anti-tumour necrosis factor (anti-TNF) biologics, infliximab (IFX) and adalimumab (ADA), are administered to induce and maintain clinical remission in patients with steroid-refractory ulcerative colitis (UC), while the subsequent loss of response to biologics during maintenance therapy remains a challenging clinical issue. This study was to evaluate the short and long-term efficacy of IFX and ADA in patients with moderately to severely active UC, anti-TNF naive, as well as those with prior exposure to an anti-TNF. Methods: In a single-centre retrospective setting, 111 consecutive patients with moderately to severely active UC refractory to corticosteroids were included. Seventy-six patients were treated with IFX; 64 naïve to an anti-TNF and 12 had switched from another anti-TNF, the remaining 35 patients were treated with ADA; 21 naïve, and 14 had switched. At week 8, clinical response rates were compared between the above 4 subgroups. Clinical response was defined as Rachmilewitz's clinical activity index (CAI) £4. The subsequent loss of response was defined as CAI ‡7. Patients with remission had received maintenance IFX (5mg/kg) every 8 weeks or ADA (40mg) at 2 weeks intervals. All patients were followed
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for 52 weeks. The cumulative remission maintenance rates were compared by the KaplanMeier estimator graphs. Results: At week 8, 59 of 76 patients (77.6%) in the IFX group had responded; 50 of 64 in the naïve subgroup (78.1%), and 9 of 12 in the switched subgroup (75.0%). Similarly, in the ADA group, 24 of 35 patients (68.6%) had responded; 15 of 21 patients in the naive (71.4%) subgroup and 9 of 14 in the switched (64.3%) subgroup. Regarding the short-term efficacy of anti-TNF agents, there was no significant difference among the 4 subgroups. Further, after 52 weeks, 65% in the IFX naïve had maintained remission vs 85.7% in the IFX switched, 69.2% in the ADA naïve, and 37.5% in the ADA switched (ADA switched vs ADA naïve and IFX group, P<0.05). Additionally, the proportion of patients in the IFX naïve with the loss of response was 25.0% vs 14.3% in the IFX switched, 30.8% in the ADA naïve, and 62.5% in the ADA switched (ADA switched vs ADA naïve and IFX group, P<0.05). The mean time to the loss of response in the ADA switched group (23.2 weeks) was shorter compared with the IFX naïve (32 weeks), IFX switched (38 weeks), or ADA naïve (44.4 weeks). (P<0.05). Conclusions:In this study, with respect to the initial clinical efficacy, there was no significant difference between IFX and ADA, regardless of prior exposure to an anti-TNF. However, the long-term remission maintenance rate was significantly lower in the ADA subgroup with prior exposure to an anti-TNF as compared to the other 3 subgroups, but this finding is limited by the small sample size of the patients with prior exposure to an anti-TNF. Quality of life (QOL) and psychological state of patients with achalasia before and after POEM. A): AC patients' QOL scores before and after POEM aP<0.05 QOL scores of AC patients vs. control. bP <0.05 QOL scores of preoperatively vs. those of 1 month postoperatively. AC: achalasia; QOL: quality of life; POEM: peroral endoscopic myotomy; PF: physical functioning; RP: role physical; BP: bodily pain; GH: general health; VT: vitality; SF: social functioning; RE: role emotional; MH: mental health. B): AC patients' SAS and SDS scores before and after POEM aP<0.05 Psychological State' scores (SAS and SDS) of preoperatively vs. those of 1 month postoperatively. bP <0.05 Psychological State' scores (SAS and SDS) of AC patients vs. control.
Su1018 Management of Gastrointestinal Symptoms in Patients Treated With Dabigatran Etexilate (Pradaxa®) Heather Paden, Naitee Ting, Daniel O'Dea Dabigatran etexilate (DE) is indicated to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Increased incidences of gastrointestinal symptoms (GIS) such as abdominal discomfort were seen in trials comparing DE to warfarin. An exploratory study evaluated 2 strategies for GIS management with DE. DE-naïve NVAF patients with no GIS for >2 weeks were followed for 3 months while taking DE in clinical trial NCT01493557. Patients reporting GIS were randomized (1:1) to either a strategy of taking DE within 30 min after a meal (+ meal) or added pantoprazole (40 mg daily). Patients whose GIS did not completely resolve with the initial strategy were to be assigned the other as add-on therapy. Management periods lasted 4 weeks. 1067 patients were enrolled and treated with DE. 117 patients (11%) self-reported GIS and were randomized: 58 to pantoprazole and 59 to DE + meal. In the pantoprazole group, 39 patients (67%) had complete symptom resolution, while 19 (33%) had partial or no resolution with the initial strategy. In the DE + meal group, 33 (56%) had complete resolution, while 26 (44%) had partial or no resolution with this initial strategy. For the second (add-on) phase, 11 of 19 patients with partial or no GIS resolution taking pantoprazole added DE + meal: 2 had symptom resolution, 6 partial resolution, and 3 no resolution or withdrew consent. Alternatively, 14 out of 26 patients with partial or no response taking DE + meal added pantoprazole: 6 had complete symptom resolution, 6 experienced partial resolution, and 2 had no resolution of their GIS symptoms. Patients who developed GIS on DE had partial or complete resolution of symptoms more frequently on an initial management strategy that included pantoprazole. Overall, 92/117 (78%) of patients with GIS and who were randomized experienced complete or partial resolution of symptoms when taking DE with a meal or concomitant pantoprazole.
Su1020 Pooled Analysis of Quality of Life Data From Two Multicenter, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trials of Bisacodyl and Sodium Picosulfate in Patients With Chronic Constipation Sabine Niedermeier, Harald Weigmann, Ursula Koehler, Marion Eberlin, Manuel Plomer, Thomas Weiser, Tobias Mueck, Erika Richter Background: Constipation occurs in at least 10 - 20 % of adults, depending on demographic factors, sampling techniques, and definitions. Although it has been previously demonstrated that quality of life (QoL) is lower in constipated than in non-constipated individuals, to our best knowledge there are only 2 randomised placebo-controlled clinical trials evaluating the influence of treatment with stimulant laxatives on QoL of these patients. Method: We analysed QoL data from 2 multicenter, 4-Week, double-blind, randomized, placebo-controlled trials (Mueller-Lissner et al 2010, Kamm et al 2011). Within the first study 367 patients suffering from constipation according to Rome III criteria were randomized to either being treated with sodium picosulfate (SPS) drops (10 mg per day) or matching placebo in a 2:1 ratio. Within the second study 368 patients were randomized to either being treated with 10 mg bisacodyl or matching placebo in a 2:1 ratio. As secondary endpoints in both studies QOL was assessed after 4 weeks of treatment using the Patient Assessment of Constipation (PAC)QOL questionnaire. The PAC-QoL is a 28-item self-administered QoL instrument designed to evaluate the patient assessment of constipation over time. It generates five scores, a total scale score, and four specific scale scores consisting of "worries and concerns" (11 items); "physical discomfort" (4 items); "psychosocial discomfort" (8 items), and "satisfaction" (5 items). Data of the two studies were pooled for analysis. Results: The overall PAC-QoL score as well as the subscores improved remarkably stronger after 4 weeks of treatment with bisacodyl and sodium picosulfate compared to placebo (Fig. 1). The subscore "satisfaction" showed the most prominent difference in improvement when compared to placebo, as well as highest intra-individual improvement. Conclusion: In conclusion, treatment of chronic constipation with the laxatives investigated (bisacodyl and SPS) improves patients disease-related quality of life in a clinically relevant manner. References: MuellerLissner et al. Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of sodium picosulfate in patients with chronic constipation. Am J Gastroenterol. 2010;105(4):897-903; Kamm et al. Oral bisacodyl is effective and well-tolerated in patients with chronic constipation. Clinical Gastroenterology and Hepatology. 2011; 9, 577-583;
Su1019 The Outcomes and Quality of Life of Chinese Patients With Achalasia After PerOral Endoscopic Myotomy: A Multi-Center Study Nan Gao, Rui Li Purpose: To assess quality of life (QOL) and psychological state of patients with achalasia after peroral endoscopic myotomy (POEM).Methods: Six hundred and twenty-seven achalasia patients underwent POEM from Jan 2011 to December 2014. The data on clinical evaluation and QOL before therapy, at one month and six months post-operation were collected and analyzed. Meanwhile, Zung's Self-rating anxiety Scale (SAS) and self-rating depression scale (SDS) were used to assess the anxiety and depression. Results: All of the six hundred and twenty-seven patients underwent POEM successfully. By comparing the data of the preoperative with that of one month and six months after POEM respectively, we found that: the mean Eckardt score decreased (7.8±1.2 vs 1.08±0.23, 7.8±1.2 vs 0.46±0.52, all p <0.05), esophagus diameter reduced (47.97 mm vs 31.40 mm, 47.97 mm vs 27.04 mm, all p <0.05), and esophageal manometry declined (29.5 mmHg vs 11.1 mmHg, 29.5 mmHg vs 9.3 mmHg, all p <0.05). No complications and recurrence occurred in all cases. At each time point, postoperative QOL scores were higher than those of preoperative (p <0.05). The anxiety and depression scores of preoperative patients were higher than normal group (SAS 49.35±6.26 vs. 30.05±6.37, SDS 50.30±5.79 vs. 29.37±7.18, all p <0.05), which were closely related to the severity degree of symptom (p <0.05). A comparison between the postoperative and preoperative groups (SAS 49.35±6.26vs. 36.60±6.17, SDS 50.30±5.79 vs. 35.20±6.36, all p <0.05) demonstrated a significant reduction in anxiety and depression. Conclusions: POEM is safe and effective treatment for achalasia, it can relieve clinic symptoms as well as improve patients'QOL, effectively relieving negative emotion. Keywords: achalasia, peroral endoscopic myotomy (POEM), short-form 36 (SF-36), quality of life, anxiety; depression
Figure 1: Adjusted (for study and baseline PAC-QOL) mean improvement from baseline in the PAC-QOL scores after 4 weeks of treatment, all P < 0.001 in favor of laxatives
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to decide the most suitable biologic medication to treat their disease. The most important considerations in choosing SEB treatment for patients were safety, efficacy, and that both the originator and biosimilar have identical review and approval processes. 96% of respondents were concerned about limited medication choice during induction and/or maintenance therapy. Conclusions IBD patients who responded to our survey were quite familiar with SEBs, although they expressed high concerns around safety, efficacy, and regulatory process. The patient choice directive is very strong and shows the need for open dialogue among patients, physicians, manufacturers, and regulatory bodies for the safe introduction of SEBs into the marketplace.
Su1015 The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Use in the Clinical Setting Hannes Holz, Natasha A. Koloski, Michael P. Jones, Marguerite DeBarros, Daniel Burger, Neal Martin, Johann Hammer, Moritz T. von Wulffen, Nicholas J. Talley, Gerald Holtmann Background: The lack of an instrument for the assessment of the severity and impact of gastrointestinal symptoms in the clinical setting prompted the development of the Structured Assessment of Gastrointestinal Symptoms (SAGIS) Instrument. We aimed to determine the reliability and validity of the SAGIS in the clinical setting. Methods: 45 patients with a variety of gastrointestinal problems referred for assessment and treatment at a large tertiary hospital were given the SAGIS prior to their consultation. The SAGIS includes questions on the severity of 23 upper and lower gastrointestinal symptoms over the past week. Responses are given on a 5 point likert scale that includes no problem, mild, moderate, severe and very severe problem. Patients also completed the validated Rome III questions for irritable bowel syndrome (IBS) and functional dyspepsia (FD), IBS Symptom Severity Scale (IBS-SSS) and the Hospital Anxiety and Depression Scale (HADS). A group of 194 patients were also given the SAGIS to complete again 1 week later to assess the test re test reliability of the measure. Results: Convergent validity was established by correlations between the individual scales of five SAGIS domains ( 1.)Epigastric Pain, 2.) IBS-D, 3.) Acid regurgitation, 4.) Nausea/Vomiting, 5.) Constipation) and the individual scales of the IBS-SSS and the HADS. Four of five SAGIS domains correlate well with the IBS-SSS (Pearson Correlation: 1.) 0.683, 2.) 0.500, 3.) 0.551, 4.) 0.474, 5.) 0.153) but none with either anxiety or depression from the HADS. Discriminant validity was assessed by correlations between the five SAGIS domains and the Rome III criteria for individuals who have IBS and FD versus do not meet criteria for these conditions. The results are supportive both in terms of where there is clear discrimination but also in terms of where there is not. For example, the IBS-D domain does clearly differentiate IBS from non-IBS but the epigastric pain domain does not, as one would expect (Wilcoxon-Mann-Whitney-Test: IBS-D 0.001, epigastric pain 0.07). The reverse is true when discriminating FD from non-FD, again as would be expected (Wilcoxon-Mann-Whitney-Test: IBS-D 0.5, epigastric pain 0.02).When n=194 patients were given the SAGIS and then retested 1 week later their paired scores for the five SAGIS domains did not change significantly with a maximum change of 12% from baseline and were well correlated ( 1.) 0.716, 2.) 0.615, 3.) 0.548, 4.) 0.634 5.) 0.660). The results indicate ordinal agreement between occasions. All Cohen's d values are well inside the small range (<0.4) (d values: 1.) 0.18, 2.) 0.11, 3.) 0.00, 4.) 0.04, 5.) 0.10). Overall the data support excellent test-retest reliability. Conclusions: The SAGIS is a reliable and valid measure that is suitable to assess severity and impact of GI symptoms in the clinical setting.
Su1013 Case-Control Analysis of Risk Factors for Poor Bowel Preparations in Outpatient Cohorts Marguerite DeBarros, Luke F. Hourigan, Natasha A. Koloski, Graeme Rich, Amanda Whaley, Louise Young, Nicholas J. Talley, Belinda Johnson, Gerald Holtmann Background: The quality of bowel preparation is a key determinant for the overall quality of colonoscopies since the polyp detection rate is adversely affected in patients with poor bowel preparation. In addition, poor bowel preparation can be costly since this may require repeat procedures. So far, quality improvement studies have aimed to improve the bowel prep regimen by modifying the regimen (e.g. split-prep versus single dose), the ingredients (e.g. PEG vs Sodium Phosphate Solution) or to identify risk factors such as underlying metabolic disorders. However, it may well be that other factors such as compliance or language barriers are critical for the quality of the bowel preparation. Methods: As part of our routine quality improvement program, we conducted a case-control study to identify risk factors associated with poor bowel preparation. In a standardised fashion, the quality of bowel preparations was assessed in all patients and those with poor bowel preparation identified. Prior to the procedure, all patients underwent standardised bowel preparation education and received split-preparation product free of charge. All patients with poor bowel preparation were matched by two patients with good bowel preparation from the same procedure list to minimise effects of inter-rater variability. For all patients and controls, comorbidities and socio-demographic background (as determined by postcode of primary residency) were assessed. Univariate (Chi-square) and logistic regression were used to quantitate. Results: Out of 434 consecutive colonoscopies during a two month period 22 were found to have a poor bowel preparation. Univariate analysis revealed that residence in a region with lower socio-economic background was a risk factor for poor bowel prep (RR 3.4, 95% CI 1.18-10.0). Age, sex, employment status, comorbidities or the need to use an interpreter were not associated with the quality of bowel prep. Conclusion: Our data demonstrates a link between socio-demographic factors and the quality of bowel preparations. It might be speculated that this is mediated via apprehension and compliance with the instructions for the bowel preparation. Our findings suggest targeted measures to improve the quality of bowel preparation in these groups.
Su1016 Fecal Immunochemical Test Versus Fecal Calprotectin for the Predictive Ability of the Prognosis of Ulcerative Colitis Asuka Nakarai, Sakiko Hiraoka, Jun Kato, Toshihiro Inokuchi, Shiho Takashima, Daisuke Takei, Yuusaku Sugihara, Masahiro Takahara, Keita Harada, Hiroyuki Okada
Su1014 Evidence of Content Validity and Psychometric Properties of Sf-36 for Measuring Health-Related Quality of Life of Patients With Crohn's Disease Aaron Yarlas, Michelle White, Mike Ingham, Chenglong Han
Abstract body Background: We previously reported that ulcerative colitis (UC) patients in clinical remission with Mayo endoscopic subscore (MES) 0 showed lower risk of relapse relative to those with MES 1-3, and a quantitative fecal immunochemical test (FIT) could be useful for evaluating relapse risk (DDW 2015). On the other hand, fecal calprotectin (Fcal) has also been reported as an important predictive factor of UC prognosis. The aim of this study was to compare the predictive ability of these two fecal markers for the clinical prognosis in UC. Methods: We prospectively observed the clinical prognosis of UC patients in clinical remission with MES 0, based on FIT and Fcal results. Results: In total, 87 UC patients in clinical remission with MES 0 were eligible to this study (46 male; median age 47 years). Their one-year relapse rate was 16%. We divided 87 patients into two groups according to the each median of FIT and Fcal results (the media of FIT; 50 ng/ml, Fcal; 65 µg/g), and compared the clinical prognosis of both groups. While the positive FIT result group (FIT > 50 ng/ml) showed statistically significantly higher risk of relapse relative to the negative FIT result group (FIT % 50 ng/ml) (Hazard ratio (HR) = 3.36; 95% confidence interval (CI), 1.98-8.60), there was no difference of clinical prognosis between the positive (Fcal > 65µg/g) and negative (Fcal % 65µg/g) Fcal result group (HR of relapse = 1.10; 95% CI, 0.47-2.65). Conclusions: FIT could predict the clinical prognosis of UC patients in clinical remission with MES 0. In contrast, Fcal could not predict in this study.
Objective: A literature review and cognitive debriefing interviews were conducted to assess the adequacy of evidence for the SF-36® Health Survey (SF-36) as a valid and reliable instrument for measuring Health Related quality of life (HRQOL) in patients with Crohn's disease (CD) in clinical trials. Methods: A literature search of several medical databases (eg Medline, Ovid) used search terms for variations of "SF-36" and "Crohn's disease" in the title or abstract of English language publications within the past 20 years. Among 327 identified abstracts, 76 full-text articles were reviewed, of which 34 articles were selected for data extraction based on appropriateness of content. Evidence of content validity and psychometric properties was evaluated based on the criteria specified in the FDA Guidance for Industry, "Patient-Reported Outcome Measures: Use in Medicinal Product Development to Support Labeling Claims." In addition, a cognitive debriefing study of the SF-36 was conducted via qualitative interviews with 16 patients with moderate-to-severe CD. Results: Concept elicitation studies supported content validity, where concepts reported by patients on the impact of CD on their daily functioning and well-being were well aligned with concepts measured by the SF-36 and were not redundant with disease-specific measures in HRQOL in CD. Cognitive debriefing interviews confirmed the relevance and comprehensiveness of all concepts covered by SF-36, as well as appropriateness of the instructions, response scales, and recall period. Evidence showed that SF-36 scores for patients with CD were consistently lower than normative scores from the general population and similar to patients with other chronic conditions such as diabetes and asthma. The literature supported the ability of SF36 scales and summary scores to detect clinically meaningful change in HRQOL in patients with CD receiving effective treatment. Convergent and discriminant validity were demonstrated by the evidence that SF-36 scores highly correlated with scores of other HRQOL measures in patients with CD and clinically meaningful differences were found on all SF36 scales when comparing patients with CD across levels of disease activity. Reported findings from samples of patients with CD included evidence for good internal consistency reliability (Cronbach's alphas ranging from 0.72 to 0.90) and good test-retest reliability (intraclass correlation coefficients ranging from 0.72 to 0.89) for all eight SF-36 scales. Conclusion: The comprehensive literature review and cognitive debriefing study demonstrated evidence for content validity and strong psychometric properties of SF-36 when used in patients with CD across different disease activities.
AGA Abstracts
Su1017 Comparative Short and Long-Term Efficacy of Infliximab and Adalimumab in Patients With Ulcerative Colitis Refractory to Corticosteroids: A Retrospective Study Naoki Yoshimura, Minako Sako, Masakazu Takazoe Background: Currently, anti-tumour necrosis factor (anti-TNF) biologics, infliximab (IFX) and adalimumab (ADA), are administered to induce and maintain clinical remission in patients with steroid-refractory ulcerative colitis (UC), while the subsequent loss of response to biologics during maintenance therapy remains a challenging clinical issue. This study was to evaluate the short and long-term efficacy of IFX and ADA in patients with moderately to severely active UC, anti-TNF naive, as well as those with prior exposure to an anti-TNF. Methods: In a single-centre retrospective setting, 111 consecutive patients with moderately to severely active UC refractory to corticosteroids were included. Seventy-six patients were treated with IFX; 64 naïve to an anti-TNF and 12 had switched from another anti-TNF, the remaining 35 patients were treated with ADA; 21 naïve, and 14 had switched. At week 8, clinical response rates were compared between the above 4 subgroups. Clinical response was defined as Rachmilewitz's clinical activity index (CAI) £4. The subsequent loss of response was defined as CAI ‡7. Patients with remission had received maintenance IFX (5mg/kg) every 8 weeks or ADA (40mg) at 2 weeks intervals. All patients were followed
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for 52 weeks. The cumulative remission maintenance rates were compared by the KaplanMeier estimator graphs. Results: At week 8, 59 of 76 patients (77.6%) in the IFX group had responded; 50 of 64 in the naïve subgroup (78.1%), and 9 of 12 in the switched subgroup (75.0%). Similarly, in the ADA group, 24 of 35 patients (68.6%) had responded; 15 of 21 patients in the naive (71.4%) subgroup and 9 of 14 in the switched (64.3%) subgroup. Regarding the short-term efficacy of anti-TNF agents, there was no significant difference among the 4 subgroups. Further, after 52 weeks, 65% in the IFX naïve had maintained remission vs 85.7% in the IFX switched, 69.2% in the ADA naïve, and 37.5% in the ADA switched (ADA switched vs ADA naïve and IFX group, P<0.05). Additionally, the proportion of patients in the IFX naïve with the loss of response was 25.0% vs 14.3% in the IFX switched, 30.8% in the ADA naïve, and 62.5% in the ADA switched (ADA switched vs ADA naïve and IFX group, P<0.05). The mean time to the loss of response in the ADA switched group (23.2 weeks) was shorter compared with the IFX naïve (32 weeks), IFX switched (38 weeks), or ADA naïve (44.4 weeks). (P<0.05). Conclusions:In this study, with respect to the initial clinical efficacy, there was no significant difference between IFX and ADA, regardless of prior exposure to an anti-TNF. However, the long-term remission maintenance rate was significantly lower in the ADA subgroup with prior exposure to an anti-TNF as compared to the other 3 subgroups, but this finding is limited by the small sample size of the patients with prior exposure to an anti-TNF. Quality of life (QOL) and psychological state of patients with achalasia before and after POEM. A): AC patients' QOL scores before and after POEM aP<0.05 QOL scores of AC patients vs. control. bP <0.05 QOL scores of preoperatively vs. those of 1 month postoperatively. AC: achalasia; QOL: quality of life; POEM: peroral endoscopic myotomy; PF: physical functioning; RP: role physical; BP: bodily pain; GH: general health; VT: vitality; SF: social functioning; RE: role emotional; MH: mental health. B): AC patients' SAS and SDS scores before and after POEM aP<0.05 Psychological State' scores (SAS and SDS) of preoperatively vs. those of 1 month postoperatively. bP <0.05 Psychological State' scores (SAS and SDS) of AC patients vs. control.
Su1018 Management of Gastrointestinal Symptoms in Patients Treated With Dabigatran Etexilate (Pradaxa®) Heather Paden, Naitee Ting, Daniel O'Dea Dabigatran etexilate (DE) is indicated to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Increased incidences of gastrointestinal symptoms (GIS) such as abdominal discomfort were seen in trials comparing DE to warfarin. An exploratory study evaluated 2 strategies for GIS management with DE. DE-naïve NVAF patients with no GIS for >2 weeks were followed for 3 months while taking DE in clinical trial NCT01493557. Patients reporting GIS were randomized (1:1) to either a strategy of taking DE within 30 min after a meal (+ meal) or added pantoprazole (40 mg daily). Patients whose GIS did not completely resolve with the initial strategy were to be assigned the other as add-on therapy. Management periods lasted 4 weeks. 1067 patients were enrolled and treated with DE. 117 patients (11%) self-reported GIS and were randomized: 58 to pantoprazole and 59 to DE + meal. In the pantoprazole group, 39 patients (67%) had complete symptom resolution, while 19 (33%) had partial or no resolution with the initial strategy. In the DE + meal group, 33 (56%) had complete resolution, while 26 (44%) had partial or no resolution with this initial strategy. For the second (add-on) phase, 11 of 19 patients with partial or no GIS resolution taking pantoprazole added DE + meal: 2 had symptom resolution, 6 partial resolution, and 3 no resolution or withdrew consent. Alternatively, 14 out of 26 patients with partial or no response taking DE + meal added pantoprazole: 6 had complete symptom resolution, 6 experienced partial resolution, and 2 had no resolution of their GIS symptoms. Patients who developed GIS on DE had partial or complete resolution of symptoms more frequently on an initial management strategy that included pantoprazole. Overall, 92/117 (78%) of patients with GIS and who were randomized experienced complete or partial resolution of symptoms when taking DE with a meal or concomitant pantoprazole.
Su1020 Pooled Analysis of Quality of Life Data From Two Multicenter, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trials of Bisacodyl and Sodium Picosulfate in Patients With Chronic Constipation Sabine Niedermeier, Harald Weigmann, Ursula Koehler, Marion Eberlin, Manuel Plomer, Thomas Weiser, Tobias Mueck, Erika Richter Background: Constipation occurs in at least 10 - 20 % of adults, depending on demographic factors, sampling techniques, and definitions. Although it has been previously demonstrated that quality of life (QoL) is lower in constipated than in non-constipated individuals, to our best knowledge there are only 2 randomised placebo-controlled clinical trials evaluating the influence of treatment with stimulant laxatives on QoL of these patients. Method: We analysed QoL data from 2 multicenter, 4-Week, double-blind, randomized, placebo-controlled trials (Mueller-Lissner et al 2010, Kamm et al 2011). Within the first study 367 patients suffering from constipation according to Rome III criteria were randomized to either being treated with sodium picosulfate (SPS) drops (10 mg per day) or matching placebo in a 2:1 ratio. Within the second study 368 patients were randomized to either being treated with 10 mg bisacodyl or matching placebo in a 2:1 ratio. As secondary endpoints in both studies QOL was assessed after 4 weeks of treatment using the Patient Assessment of Constipation (PAC)QOL questionnaire. The PAC-QoL is a 28-item self-administered QoL instrument designed to evaluate the patient assessment of constipation over time. It generates five scores, a total scale score, and four specific scale scores consisting of "worries and concerns" (11 items); "physical discomfort" (4 items); "psychosocial discomfort" (8 items), and "satisfaction" (5 items). Data of the two studies were pooled for analysis. Results: The overall PAC-QoL score as well as the subscores improved remarkably stronger after 4 weeks of treatment with bisacodyl and sodium picosulfate compared to placebo (Fig. 1). The subscore "satisfaction" showed the most prominent difference in improvement when compared to placebo, as well as highest intra-individual improvement. Conclusion: In conclusion, treatment of chronic constipation with the laxatives investigated (bisacodyl and SPS) improves patients disease-related quality of life in a clinically relevant manner. References: MuellerLissner et al. Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of sodium picosulfate in patients with chronic constipation. Am J Gastroenterol. 2010;105(4):897-903; Kamm et al. Oral bisacodyl is effective and well-tolerated in patients with chronic constipation. Clinical Gastroenterology and Hepatology. 2011; 9, 577-583;
Su1019 The Outcomes and Quality of Life of Chinese Patients With Achalasia After PerOral Endoscopic Myotomy: A Multi-Center Study Nan Gao, Rui Li Purpose: To assess quality of life (QOL) and psychological state of patients with achalasia after peroral endoscopic myotomy (POEM).Methods: Six hundred and twenty-seven achalasia patients underwent POEM from Jan 2011 to December 2014. The data on clinical evaluation and QOL before therapy, at one month and six months post-operation were collected and analyzed. Meanwhile, Zung's Self-rating anxiety Scale (SAS) and self-rating depression scale (SDS) were used to assess the anxiety and depression. Results: All of the six hundred and twenty-seven patients underwent POEM successfully. By comparing the data of the preoperative with that of one month and six months after POEM respectively, we found that: the mean Eckardt score decreased (7.8±1.2 vs 1.08±0.23, 7.8±1.2 vs 0.46±0.52, all p <0.05), esophagus diameter reduced (47.97 mm vs 31.40 mm, 47.97 mm vs 27.04 mm, all p <0.05), and esophageal manometry declined (29.5 mmHg vs 11.1 mmHg, 29.5 mmHg vs 9.3 mmHg, all p <0.05). No complications and recurrence occurred in all cases. At each time point, postoperative QOL scores were higher than those of preoperative (p <0.05). The anxiety and depression scores of preoperative patients were higher than normal group (SAS 49.35±6.26 vs. 30.05±6.37, SDS 50.30±5.79 vs. 29.37±7.18, all p <0.05), which were closely related to the severity degree of symptom (p <0.05). A comparison between the postoperative and preoperative groups (SAS 49.35±6.26vs. 36.60±6.17, SDS 50.30±5.79 vs. 35.20±6.36, all p <0.05) demonstrated a significant reduction in anxiety and depression. Conclusions: POEM is safe and effective treatment for achalasia, it can relieve clinic symptoms as well as improve patients'QOL, effectively relieving negative emotion. Keywords: achalasia, peroral endoscopic myotomy (POEM), short-form 36 (SF-36), quality of life, anxiety; depression
Figure 1: Adjusted (for study and baseline PAC-QOL) mean improvement from baseline in the PAC-QOL scores after 4 weeks of treatment, all P < 0.001 in favor of laxatives
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