bluuebunny/crossref_metadata_2025_split huggingface dataset:
823 Fecal Calprotectin Levels, C-Reactive Protein Levels, and Partial Mayo Score as Early Predictors of Clinical and Endoscopic Outcomes in Patients With Ulcerative Colitis Treated With Tofacitinib in a Phase 2 Study
Authors: Dubinsky Marla C. , Hudesman David P. , Kulisek Nicole , Salese Leonardo , Paulissen Jerome , Su Chinyu , Magro Fernando 
Published: October 2019

INTRODUCTION:
Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Fecal calprotectin (FCP) levels correlated with clinical and endoscopic outcomes at Week (Wk) 8 in patients (pts) with moderately to severely active UC receiving tofacitinib in a Phase 2 study (1). In these post hoc analyses, we aimed to determine if FCP levels, C-reactive protein (CRP) levels, or partial Mayo score (PMS) can be early predictors of clinical or endoscopic outcomes in a Phase 2, randomized, double-blind, placebo-controlled study (NCT00787202) (2).

METHODS:
FCP levels and PMS at baseline, Wk 2, and Wk 4, and CRP levels at baseline and Wk 4 were analyzed based on whether pts with moderately to severely active UC treated with tofacitinib 10 mg twice daily (BID) had clinical response, clinical remission, mucosal healing, or endoscopic remission at Wk 8. Univariate logistic regression analyses were used to evaluate if FCP levels (log transformed), CRP levels (log transformed), or PMS were associated with each outcome.

RESULTS:
In pts treated with tofacitinib 10 mg BID (N = 28), numerically greater decreases from baseline were observed in FCP levels and PMS at Wks 2 and 4 in pts who achieved clinical response, clinical remission, mucosal healing, and endoscopic remission at Wk 8 vs those who did not. FCP levels at Wk 2 decreased by >50% from baseline in pts who achieved endoscopic remission. Numerically greater decreases from baseline were observed in CRP levels at Wk 4 in pts who achieved clinical response and mucosal healing at Wk 8 vs those who did not (Table 1). In pts treated with tofacitinib 10 mg BID, logistic regression results (shown as odds ratio [95% confidence interval]) showed that PMS at Wk 2 (0.496 [0.288, 0.856]; P = 0.0117) and Wk 4 (0.463 [0.251, 0.853]; P = 0.0135), and CRP levels at Wk 4 (0.582 [0.342, 0.990]; P = 0.0460), were significantly associated with clinical remission at Wk 8, and that PMS at Wk 4 (0.572 [0.345, 0.948]; P = 0.0302) was significantly associated with clinical response at Wk 8.

CONCLUSION:
These post hoc analyses of a Phase 2 study showed that decreases as early as Wk 2 in FCP levels and PMS, and as early as Wk 4 in CRP levels, may be predictors of improved clinical and endoscopic outcomes in pts with moderately to severely active UC treated with tofacitinib 10 mg BID, although definitive conclusions cannot be drawn due to low pt numbers.
825 Ulcerative Colitis Experiences Among a Pediatric Population: A Qualitative Study Reviewing the Agreement of Symptoms Discussed by Children and Their Parents
Authors: Randall Jason , Guobyte Aiste , Delbecque Laure , Newton Louise , Symonds Tara , Hunter Theresa 
Published: October 2019

INTRODUCTION:
Although key symptoms of UC are well-known, exploration of these in children and the level of agreement between child reported and those observed by parents/caregiver have not been well documented and is important to understand if patient reported or observer reported outcome measures should be used.

METHODS:
Children with UC aged 5–11 years and their parents were recruited from US clinical sites for face-to-face concept elicitation interviews. Collages and play-doh models were used during child interviews. Interview transcripts were subjected to thematic analysis using NVivo.

RESULTS:
In total 24 participants were interviewed, three children aged 5–7 years, nine children aged 8–11 years, and their parents/caregivers. All children and parents/caregivers reported that they/their child experienced abdominal pain. Among the younger children, all children and parents/caregivers also discussed blood in stool and there was general agreement (>66%) for stool urgency and incontinence. However, parents/caregivers in this age group were more likely to mention a symptom that was not reported by their child, e.g., stool frequency, constipation, and mucus in stool. The agreement in the description of the experience of symptoms was much higher in 8–11-year olds. There was a high level of agreement (>75%) for blood in stool frequency, diarrhea, incomplete evacuation, and feeling gassy or passing gas. Constipation, bloating, and cramping all had a moderate level of agreement (>50%).

CONCLUSION:
The findings showed a high level of agreement between children and their parents/caregivers in reporting the child’s symptoms. Children aged 8–11 years demonstrate higher agreement with their parents/caregivers than younger children. To obtain an accurate picture of symptoms experienced, an observer-reported measure should be used for the 5–7-year olds, but 8–11-year olds could self-report own symptoms. Limitations: only three 5-7-year olds were interviewed.
831 Serum Biomarkers Are Associated With Endoscopic and Clinical Outcomes in Crohn’s Disease Patients Receiving Vedolizumab Therapy
Authors: Holmer Ariela , Battat Robert , Dulai Parambir , Casteele Niels Vande , Neill Jennifer , Le Helen N. , Miralles Ara , Jain Anjali , Hester Kelly , Singh Siddharth , Rivera-Nieves Jesus , Sandborn William J. , Boland Brigid , Nguyen Nghia 
Published: October 2019

INTRODUCTION:
Vedolizumab is a selective monoclonal antibody directed against a4b7 integrin on lymphocytes and is safe and effective for the induction and maintenance of remission in Crohn’s disease. Serum biomarkers are needed to help guide therapy and predict patient outcomes. This study evaluated biomarker concentrations and patient outcomes during vedolizumab treatment.

METHODS:
Serum was collected from patients with Crohn’s disease receiving vedolizumab infusions at weeks 0, 2, 6, 14 and ≥26. Biomarkers including soluble(s)-a4b7, s-vascular cell adhesion molecule (VCAM)-1, s-intracellular adhesion molecule (ICAM)-1, and s-mucosal addressin cell adhesion molecule (MAdCAM)-1 were measured and evaluated as surrogate markers associated with clinical and endoscopic outcomes. Statistical analysis was performed using the Mann-Whitney U test for continuous data.

RESULTS:
Twenty-two patients with Crohn’s disease were included (Table 1). In all patients, s-MAdCAM significantly decreased over time as compared to baseline, and s-a4b7 increased compared to baseline (Figure 1). Overall, s-ICAM1 and s-VCAM1 did not change significantly over time in the entire cohort, however, differentially changed in patients with remission. At week 2, median concentrations of s-ICAM1 were higher in patients with compared to those without clinical remission: 675.1 ng/mL vs. 270.1 ng/mL, respectively (P = 0.046). At week 6, median s-ICAM1 concentrations were higher in patients with compared to without endoscopic remission: 545.7 ng/mL vs. 286.2 ng/mL, respectively (P = 0.027) and clinical remission: 669.1 ng/mL vs. 291 ng/mL, respectively (P = 0.034). At week 6, median s-VCAM1 concentrations were higher in patients with compared to without endoscopic remission: 859.6 vs. 460.31, respectively (P = 0.027) and numerically higher in patients with clinical remission: 859.6 ng/mL vs. 460.6 ng/mL, respectively (P = 0.1). At week 26, there was no difference in median s-VCAM1 or s-ICAM1 concentrations between remitters vs. non-remitters (Table 2).

CONCLUSION:
Higher concentrations of s-ICAM-1 and s-VCAM-1 early in treatment with vedolizumab may be predictive of subsequent remission in patients with Crohn’s disease. During maintenance, there was no association between serum biomarkers and endoscopic or clinical outcomes. These findings may help predict early patient response to treatment with vedolizumab in Crohn’s disease but will require further validation.
833 The Impact of Trainee Physician Experience on Costs and Treatment Outcomes Among Patients Hospitalized With Ulcerative Colitis
Authors: Kachru Sumyra , Abougergi Marwan S. 
Published: October 2019

INTRODUCTION/AIM:
The efficiency and the delivery of care have been at the center of the current healthcare debate and reform. We sought to investigate the “July effect” on resource utilization among patients admitted to teaching hospitals with ulcerative colitis.

METHODS:
This was a retrospective cohort study using the 2016 Nationwide Inpatient Sample (NIS), the largest public inpatient database in the US. Patients with a principal diagnosis of Ulcerative colitis (UC) were included. Patients were excluded if they were younger than 18 years or treated at non-teaching hospital. The primary outcome was total hospitalization charges associated with the hospital admission for UC. Secondary outcomes were 1) length of stay 2) in-hospital mortality and 3) surgical intervention. Patient outcomes at the start of the academic year (July- September) were compared with those at the end of the academic year (April -June). Proportions were compared using fisher’s exact test and continuous variables using student t- test. Multivariate analysis was used to adjust for gender, age, Charlson Comorbidity Index, income in patient zip code, hospital region, location, size and teaching status.

RESULTS:
24,650 patients were included in the study. The mean age was 46 years and 54% were females. Compared with patients admitted in July/August/September, those admitted in April/May/June had an adjusted mean difference in total hospitalization charges of 7,380$, (95% Confidence Interval (CI: $14,160 - $599, P = -0.03). Similar results were obtained for Length of Stay: Compared with patients admitted in July/August/September, those admitted in April/May/June, had an adjusted mean difference in length of stay of 0.7 days, CI: 1.3 -0.1, P = 0.02. There was no statistically significant difference in in-hospital mortality rate (adjusted odds ratio (aOR): 0.60, CI: 0.13-2.80, P = 0.51) or surgery rate (aOR: 0.91, CI: 0.59- 1.40, P = 0.68) among the two patient groups.

CONCLUSION:
The experience of the physician in training affects efficiency of care among patients admitted to the hospital with ulcerative colitis, but does not seem to impact treatment outcomes including in-hospital mortality and colectomy rate.
850 Long-Term Consequences of Surgery in Patients With Ulcerative Colitis: A Study Using German Claims Data
Authors: Ghiani Marco , Naessens Dominik , Takacs Peter , Myers David , Maywald Ulf , Bokemeyer Bernd , Wilke Thomas 
Published: October 2019

INTRODUCTION:
Proctocolectomy in patients with ulcerative colitis (UC) is traditionally considered curative. However, little is known on the long-term complications and costs of surgery in UC and previous literature mostly relied on hospital registry data. Using German claims data, this study explored long-term healthcare resource utilization (HCRU) and costs among UC patients who had surgery and patients who did not.

METHODS:
Patients from a German health insurance with a UC diagnosis between 01/01/2010-31/12/2017 were included. Patients who had proctocolectomy or colectomy after first UC diagnosis and between 01/07/2010-31/12/2014 were identified and surgery date was set as index. Non-surgery patients were given a random index date in the inclusion period after first UC diagnosis, and were required to have received a corticosteroid or biologic in the six months before index. A 1:2 nearest-neighbor propensity score matching (PSM) with replacement was used and UC-related hospital stays and costs, as well as outpatient visits, were studied in the three years after index.

RESULTS:
Of 21,392 UC patients, 76 were included in the surgery group (34 proctocolectomy, 37 colectomy, 5 other) and 114 in the non-surgery group. Matched cohorts did not differ significantly in the baseline characteristics and mortality rates where high in both groups (21.1% and 29.0%, respectively). Patients who had surgery relied less on biologics compared to patients who did not (10.5% vs 23.7%, P = 0.022), but the number of UC-related hospitalizations per-patient-year (PPY) was twice as large in the surgery group than in the non-surgery group (0.4 vs 0.2, P < 0.001), and no significant difference in the number of UC-related outpatient visits PPY was observed (7.2 vs 7.0, P = 0.364). This resulted in higher UC-related hospitalization costs for patients who had surgery (cost-ratio = 4.3, 95% CI: 2.0, 6.7). Costs of UC-related medications were lower for patients who had surgery (cost-ratio = 0.2, 95% CI: 0.0, 0.4), but they increased over the follow-up period for patients in the surgery group and approached costs in the non-surgery group.

CONCLUSION:
While PSM does not account for unobservable confounders and further research on patients who had proctocolectomy is required, this work is the first to study long-term HCRU and costs among UC patients who had surgery and patients who did not, based on claims data. Results show that surgical options may be not curative and result in high hospitalization costs.
861 Mind the Gap: A Comparison of the Randomized Clinical Trial Efficacy and Real World Effectiveness of Tofacitinib for the Treatment of Inflammatory Bowel Disease
Authors: Rudrapatna Vivek A. , Butte Atul J. 
Published: October 2019

INTRODUCTION:
Randomized clinical trials (RCTs) represent the gold standard for clinical evidence. However, they have also raised concerns over generalizability due to unrealistic patient selection and endpoints. Real-world data (RWD) is receiving growing interest from the FDA as a complementary source of evidence. However, the suitability of these data for RCT-grade evidence and best practices in their use remain unclear. Here we compare the real-world effectiveness of Tofacitinib with efficacy assessed by RCTs of Inflammatory Bowel Disease (IBD).

METHODS:
Electronic health records (EHR) at the University of California San Francisco (UCSF) were reviewed for IBD patients prescribed Tofacitinib following a pre-protocol. The primary outcome was drug effectiveness measured by continued use and by RCT endpoints. Secondary outcomes assessed the completeness of RWD to measure RCT endpoints and the number of patients meeting RCT inclusion criteria.

RESULTS:
68 Ulcerative Colitis (UC) and 18 Crohn’s Disease (CD) patients received Tofacitinib (Figure 1). Most of the data needed to calculate the RCT endpoints was available in the EHR (77% and 91%) with the remainder imputed. The baseline characteristics of the UCSF and trial cohorts were similar, except for greater disease duration and 100% TNFi failure in UCSF patients (Table 1). However, 0% of the real-world UC cohort met the RCT inclusion criteria (Table 2). The rate of continued treatment at 1 year was greater than 50% irrespective of disease subtype. Time-to-treatment-failure curves were nearly identical for UC and CD, with all drop-off occurring within the first 6 months. This rate of continued treatment in practice was significantly greater than the RCT primary endpoint and least stringent secondary endpoint (P-values 0.003 and 0.08) for UC, and for CD (P-value 0.02). However, the rates of meeting the primary endpoint for both subtypes using the Mayo score and CDAI were identical (P-values 0.5 and 1.0).

CONCLUSION:
Routinely collected data is sufficiently detailed to measure IBD trial endpoints. Analysis of RWD reproduced Tofacitinib efficacy measured by RCTs, despite trial selection criteria excluding most UCSF patients. However, real-world use patterns indicate much greater treatment durability than that suggested by trial endpoints, likely related to different treatment failure thresholds used in clinical care. These results support a role for JAK inhibition in CD, and overall highlight the value of real-world evidence to complement that obtained by RCTs.
862 Patient Attitudes Towards Pre-Procedure Telehealth Visits Prior to Advanced Endoscopic Procedures: Results of a Pilot Survey
Authors: Suresh Suraj , Menees Stacy , Saini Sameer D. , Prabhu Anoop 
Published: October 2019

INTRODUCTION:
Telehealth is an emerging technology that enables remote video visits between providers and their patients. The role of a telehealth visit prior to high-risk endoscopy has not been evaluated. The purpose of this study was to pilot a patient survey to assess experiences and preferences for different visit types including telehealth (TH), face-to-face (F2F), and direct access (DA) (i.e., without meeting with a GI physician) prior to undergoing advanced endoscopic procedures.

METHODS:
We developed a survey instrument to assess patient knowledge and preference regarding visit types prior to advanced endoscopic procedures. The survey was refined through input from an expert survey working group. The questionnaire was then administered immediately prior to informed consent to patients undergoing advanced endoscopy procedures at a tertiary referral academic VA medical center. Exclusion criteria included inability to consent and prior exposure to advanced endoscopic procedures. Data were collected on demographics, computer and health literacy, knowledge of procedural risks, benefits, and alternatives, comfort with the proceduralist, visit satisfaction, and overall preference of pre-procedural visit modality. Differences between groups were analyzed using a Chi-Square test.

RESULTS:
A total of 40 patients completed the pilot questionnaire (Table 1). 20 patients were in the DA group, 11 in the F2F group, and 9 in the TH group. Most respondents in the TH and F2F visit groups (78% and 82%, respectively) were satisfied with their visit types and would choose the same visit modality in the future (Table 2, Figure 1). In contrast, significantly fewer (30%, P = 0.003) in the DA group were satisfied with their visit type. Patients with transportation difficulties were more likely to choose a TH visit (P = 0.018).

CONCLUSION:
In this pilot survey, a telehealth visit prior to advanced endoscopic procedures appears to be an acceptable alternative to a F2F visit in terms of patient satisfaction. Most respondents preferred a pre-procedural clinic visit with GI (via either telehealth or F2F) over DA, underscoring the importance of a measured discussion about risks and alternatives for high-risk endoscopic procedures. In the future, telehealth could be considered the visit modality of choice for patients referred for advanced endoscopic procedures who live a significant distance from the procedure site. These results will be confirmed with a larger sample in a future study.
863 Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography: Performance Ratings From a Case Series of 60 Patients
Authors: Muthusamy V. Raman , Bruno Marco , Kozarek Richard , Petersen Bret , Pleskow Douglas , Sejpal Divyesh , Slivka Adam , Peetermans Joyce , Rousseau Matthew , Tirrell Gregory , Ross Andrew 
Published: October 2019

INTRODUCTION:
Exogenous transmission of infection via duodenoscope cross-contamination after failed disinfection is a preventable risk. Inadequate reprocessing of reusable duodenoscopes can occur. Given this possibility, a new single-use duodenoscope was recently developed. It had comparable performance to reusable duodenoscopes when tested by expert endoscopists in a comparative bench model for endoscopic retrograde cholangiopancreatography (ERCP). We subsequently aimed to assess the performance of this disposable duodenoscope in a series of human cases.

METHODS:
Six academic medical centers enrolled consecutive adults 18 years or older without altered pancreaticobiliary anatomy scheduled for an ERCP. Seven ERCP experts rated the new EXALT single-use Model D duodenoscope (Boston Scientific, Marlborough, MA; ClinicalTrials.gov NCT03701958) in ERCP procedures for Overall Satisfaction on a scale of 1 (unsatisfied) to 10 (very satisfied), “Not preferred/Neutral/Preferred” compared to reusable duodenoscopes on 23 ERCP maneuvers, and Qualitative Comparison of 17 performance characteristics on a scale of 1 (not preferred) to 5 (comparable to reusable duodenoscopes).

RESULTS:
Sixty consecutive patients had an ERCP using the first-generation single-use duodenoscope in April and May 2019. Thirty-seven (61.7%) were male, mean age was 64.4 years, and 44 (73.3%) had a prior ERCP at baseline. All 60 ERCP procedures were successfully performed, 58 (96.7%) with the single-use duodenoscope alone and 2 (3.3%) with crossover to a reusable duodenoscope. Median overall satisfaction with the single-use duodenoscope was rated 9.0 (range 1-10). The overall satisfaction rating was ≥ 7 in 56 (93.3%) ERCPs. All three ratings were at or above midpoint (Overall satisfaction ≥ 5, Comparative ERCP maneuver “Neutral/Preferred,” Qualitative Comparative rating of performance characteristic 3-5) in 47 (78.3%) cases. Four ERCPs had low (≤4) overall satisfaction ratings attributed to inadequate pushability of instruments due to suboptimal positioning of the duodenoscope in front of the papilla; these ERCPs were a subset in which biliary or pancreatic duct strictures were dilated and/or stented.

CONCLUSION:
Expert endoscopists reported good overall performance of a new single-use duodenoscope in a broad array of cases. Low ratings occurred rarely and were associated with particular ERCP maneuvers. Detailed design improvements to the single-use duodenoscope are underway.
881 Is There a "July Effect" for Endoscopic Variceal Band Ligation in Teaching Hospitals?
Authors: Rodgers Brandon , Patel Pavan , Ahlawat Sushil 
Published: October 2019

INTRODUCTION:
The July effect describes the increased morbidity and mortality that studies have shown when new trainees begin in teaching hospitals in the United States. The July effect has not been shown to impact outcomes of screening colonoscopy or ERCP, but to our knowledge no study has assessed the July effect in endoscopic variceal band ligation. Our study aimed to assess whether there was a July effect associated with endoscopic variceal band ligations for patients with variceal hemorrhage in teaching hospitals.

METHODS:
The National Inpatient Sampl (NIS) is the largest all-payer inpatient database in the United States, consisting of approximately seven million hospital stays. We collected data from 2008 to 2012. International Classification of Disease, Ninth Edition codes were used to identify patients with a diagnosis code of variceal hemorrhage and procedure code for ligation of esophageal varices, endoscopic excision or destruction of lesion or tissue of esophagus, or ligation of gastric varices. Patients that were included were admitted in the “early” months of July, August or September, or those in the “late” months of April, May or June.

RESULTS:
A total of 477 (weighted = 2378) patients with variceal hemorrhage and endoscopic band ligation were identified. 231 (weighted = 1148) patients were admitted in the early period, and 246 (weighted = 1230) in the late period. There was a significant difference in length of stay (days) (7.11 ± 7.38 vs. 8.69 ± 13.01 P = 0.0003) and incidence of post procedure infection (.04% vs. 1.3% P = 0.024). There was no significant difference between the early and late groups in all-cause mortality (11.1% vs. 8.8% P = 0.107). When controlled for cofounding factors including demographics, number of medical comorbidities and hospital characteristics in regression analysis, incidence of post procedure infection remained significant (OR = 0.098, 95% CI: 0.015, .650, P = 0.016). There remained no significant difference in mortality (OR = 0.697, 95% CI: 0.423-1.147, P = 0.156). After controlling for cofounders using regression, LOS also remained significant (β = -0.59, P = 0.0003).

CONCLUSION:
Our analysis shows increased length of stay and post procedure infections in the later academic months, with no difference in mortality. These differences found in our analysis could possibly be attributed to less experienced trainees having more opportunities to perform band ligation procedures in the later academic months compared to earlier months.