bluuebunny/crossref_metadata_2025 huggingface dataset:
P121 REAL WORLD PREVALENCE OF BOWEL MOVEMENT URGENCY – A SNAPSHOT OF SYMPTOM EXPERIENCE REPORTED BY PATIENTS WITH ULCERATIVE COLITIS PARTICIPATING IN SPARC IBD
Authors: Naegeli April , Dong Yan , Zhou Xian , Morris Nathan , Arora Vipin , Lissoos Trevor
Published: January 2020

Background

Urgency, also referred to as bowel movement urgency or bowel urgency, is the sudden need for a bowel movement. Bowel urgency is one of the most bothersome and important symptoms experienced by patients with ulcerative colitis (UC), contributing to decrements in quality of life. Bowel urgency is distinct from the common symptoms associated with UC, namely stool frequency and rectal bleeding, however patients often experience all symptoms, urgent, frequent bowel movements with bleeding, concurrently. Bowel movement urgency is a key symptom for triggering clinical consideration of UC diagnosis and for defining more severe disease activity in clinical practice.

Methods

The results published here are based on data obtained from the IBD Plexus program of the Crohn’s & Colitis Foundation. To better understand the prevalence of bowel movement urgency in patients with UC, an ad hoc analysis was performed using data from a Study of a Prospective Adult Research Cohort with IBD (SPARC IBD), a multicenter longitudinal study of adult patients with IBD that collects and links clinical data, patient-reported outcome (PRO) data, and serial bio-samples throughout the course of the patients’ disease. The enrollment visit was defined as 7 days from the patients’ date of enrollment in SPARC IBD. At study enrollment, patients were asked to answer questions based on their symptom experiences. Patients reported how much urgency they experienced before bowel movements on average during the past 3 days (none, mild, moderate, moderately severe, severe, not applicable). Descriptive analyses for patient demographic and disease characteristics were conducted. Additionally, contingency table analyses were conducted exploring the association of urgency with other UC symptoms and other measures of UC disease severity.

Results

Of 1,833 patients included in the SPARC IBD data cutoff of May 13, 2019 (Enrolled from 08 November 2016 to 15 May 2019), 582 were patients with UC, of which 514 had urgency data available. Overall, 51.8% of patients were male, and the mean age is 42.4 years (Table 1). At enrollment, 59.7% of patients reported some level (mild, moderate, moderately severe/severe) of urgency. Forty-six percent of UC patients with urgency data were receiving biologic treatment with 31% still reporting mild urgency, and 32% reporting moderate to severe urgency (Table 1). The severity of urgency was associated with patient reported severity of other UC symptoms and disease activity (Table 2).

Conclusion

Results from ad hoc analyses using a real-world sample of patients with UC suggest that bowel movement urgency is a prevalent symptom of UC which varies with disease activity.
P007 CROHN’S DISEASE: PREDICTORS OF HOSPITAL DISPOSITION AND COSTS USING DEMOGRAPHIC, CLINICAL, AND TREATMENT DATA
Authors: Brunt Hartman , Adams Mason , Barker Michael , Hamer Diana , Chapman J C
Published: January 2020

Purpose

Crohn’s disease (CD) is an inflammatory bowel disease (IBD) caused by an abnormal immune response to intestinal microbes in a genetically susceptible host. The objective of this cohort analysis is to compare demographic characteristics, cost difference, and treatment modalities between patients who were discharged from the Emergency Department (ED) and those who were admitted to the hospital.

Methods

This study is a retrospective chart review of adult patients diagnosed with CD who were discharged from the ED and those who were admitted to the hospital between January 1, 2014 and January 1, 2017. We compared demographic and clinical characteristics as well as total charges incurred by these patients. A chi square test of independence and a Mann Whitney U-Test were used to compare categorical variables. Linear and logistic regression analyses were utilized to identify predictors of hospitalization and total charges.

Results

Of a total 195 patients, 97 were discharged from the ED and 98 were admitted to the hospital (Table 1). Patients who presented with fever, nausea/vomiting, or abdominal pain or who had a history of a fistula or stenosis were more likely to be hospitalized, as were patients who presented on steroids, 5-ASA compounds, or narcotics (Table 2). A logistic regression adjusted for these factors showed patients presenting with abdominal pain (OR=0.239, 95% CI 0.07 – 0.77) are less likely, while patients presenting with fever (OR=7.0, 95% CI 1.9 – 24.5) and history of stenosis (OR=17.8, 95% CI 5.7 – 55.9) are more likely to have a hospital admission. An increase in age and white blood cell count was associated with an increase in likelihood of admission (OR=1.04, 95% CI 1.01 – 1.07 and OR=1.2, 95% CI 1.1 – 1.4), while an increase in HGB was associated with a decrease in likelihood of admission (OR=0.682, 95% CI 0.55 – 0.83). Patients on 5-ASA compounds had the strongest association with hospital admission (OR=4.5, 95% CI 1.03 – 20.4). A linear regression analysis predicting total charges of hospitalization identified an increase of $37,500 (95% CI 6,600 – 68,489) for obese patients and of $29,000 (95% CI 20 – 57,000) for patients on narcotics prior to hospitalization. Notably, blacks were on average 6 years younger than whites (μ=36.2, st.d.=13.2 v μ=42.7, st.d.=18.2, p=0.031, respectively). No other differences in presentation or outcomes of CD were identified between these races.

Conclusion

This study describes the difference between CD patients who were admitted to the hospital compared to those who were discharged from the ED. The impact that 5-ASA compound, steroid, and narcotic use prior to presentation has on hospital admission and charges highlights the need for consistent outpatient care to manage the symptoms and disease progression in patients with CD in Baton Rouge. The difference in age at presentation between blacks and whites should also be considered in future research.
P008 EVALUTING THE EFFECTIVENESS OF TRANSITION OF CARE FOR PEDIATRIC INFLAMMATORY BOWEL DISEASE PATIENTS USING A STANDARDIZED TRANSITION PROCESS
Authors: Shearer Jennifer , Perry Sharon , Lidyard Nicole , Burkhart Kimberly , Katz Jeffry , Apperson Carolyn , Moses Jonathan
Published: January 2020

Significance

The incidence of inflammatory bowel disease (IBD) is rising around the globe. As pediatric IBD patients approach adulthood, they are in jeopardy of a lapse in care. We developed a standardized a health maintenance transition visit (HMV) to supplement standard medical care visits (SMV) to prepare patients for transition. Our aim was to assess the effectiveness of the structured HMV using the Transition Readiness Assessment Questionnaire (TRAQ) to predict readiness at time of transfer to an adult gastroenterologist.

Methods

A retrospective chart review was conducted including demographics and clinical data from HMV visits and pediatric or adult SMV visits. Clinical variables included scheduling, providers, TRAQs, Patient Health Questionnaire-9 (PHQ9), health maintenance goals, and disease status. The effectiveness of the HMV was accessed by attendance, PHQ9 screening, adherence to health recommendations, and TRAQ scores.

Results

140 patients completed at least one HMV. The patient cohort was 80% white and 59% male. Mean age was 18 ± 2 years old at the time of their first HMV. The majority of patients had a primary IBD diagnosis of Crohn’s disease (75%), followed by ulcerative colitis (21%), and unclassified IBD (4%). Most patients had inactive disease (68%) around the time of the first HMV, while a minority had mild (20%) or moderate (12%) disease activity based on PGA. The average TRAQ score at the first HMV visit was 66 ± 17. Patients who completed at least 1 prior HMV (n=8) scored significantly higher on the TRAQ when transferring to the adult care compared to patients (n=29) who were transferred at their first HMV visit (92 vs 83, p<0.05). Of the 56 patients who completed the PHQ9 depression screen, 22 had a positive screen. Of the patients with no prior diagnosis of depression, 36% had a positive screen with the severity of depression ranging from mild to severe. Across all visits, 45 patients were transferred into adult care following a HMV.

Conclusions

This study demonstrated that a structured HMV prior to transfer may increase transition readiness as assessed by the TRAQ. In addition, new diagnosis of depression was made in a significant portion of patients screened, emphasizing the importance of regular screening for psychological issues. Future studies are needed to validate these findings and potentially move towards a standard template for transition readiness in pediatric IBD patients.
P014 IBD AND VTE RISK: LET’S TALK ABOUT IT
Authors: Dave Jenny , Chawla Karan , Carro-Cruz Francis , Rao Vinay , Gibilisco Jessica , Baumgartner Scott , Negreira Katherine , Borum Marie
Published: January 2020

Background

Patients with inflammatory bowel disease (IBD) have a 1.5–3 fold increase in the risk of venous thromboembolism (VTE). Additionally, VTE in patients with IBD is associated with a 2.1 fold increase in mortality compared to the general population. The risk of VTE is increased with active inflammation. It is speculated that individuals with IBD are inconsistently advised about VTE risk. This study evaluated the frequency of counseling about VTE in IBD patients.

Methods

A retrospective medical record review of all IBD patients seen at a university gastroenterology practice during a 5 year period was performed. Patients’ age, gender, disease type and documented counselling about VTE risk were obtained. A database was created maintaining patient confidentiality. Analysis was conducted using Fisher’s Exact Test with significance set at p< 0.05. The study was approved by the university IRB.

Results

Records of 381 patients were reviewed. There were 209 females and 172 males with a mean age of 44 years (range 20–82). 279 had ulcerative colitis, 96 had Crohn’s disease and 6 had indeterminate colitis. Self-reported ethnicity included 195 White, 97 Black/African-American (AA), 11 Asian, 1 Hawaiian, 34 other and 43 did not report their ethnicity. 13 (3.4%) patients (7 females, 6 males) were counselled about VTE risk. The 7 women who were counselled were <50, with no significant difference in counselling of women <50 compared to women >50 (p=0.11). The 6 men who were counseled were <50, with no significant difference in counseling of men <50 compared to men >50 (p=0.09). There was no difference in the rate of counselling based upon gender (p=1.000), ethnicity (Whites vs. non-Whites, p=0.77; Whites vs. AA, p=1.00) or disease type (p=0.31).

Discussion

Venous thromboembolism is a known risk of inflammatory bowel disease. While VTEs infrequently occur in IBD patients, it is important that there is awareness about the potential risk. This study revealed that VTE risk is rarely discussed with IBD patients. While this study is limited by single institutional design, size and reliance on documentation, it suggests that increased efforts can be made to educate IBD patients about VTEs. Recognition of VTE risks can improve IBD management and optimize clinical outcomes.
P002 IBD PARTNERSHIPS: UNDERSTANDING PATIENTS VS. CLINICIANS PERSPECTIVES OF IBD TREATMENT OPTIONS TO IMPROVE SHARED DECISION-MAKING
Authors: Zelinsky Sandra , Finlayson Catherine
Published: January 2020

Background

The patient is the only constant in the care journey, the person who experiences both processes and the outcomes of care. There is an international shift towards including patients as equal partners in research. Co-producing research with Inflammatory Bowel Disease (IBD) patients to understand their values, needs and priorities when making treatment decisions will potentially improve shared decision-making between IBD patients and their Healthcare Providers (HCPs). To facilitate this process patients and HCPs must have a common understanding of expected medication benefits, risks and the potential impact on quality of life. The information available to facilitate this conversation must be aligned and reflect the priorities that IBD Patients and Healthcare Providers consider when making treatment decisions. Both parties can then share information and work towards an agreement to what treatment plan should be implemented.

Aims

To understand what matters most to IBD patients when making treatment decisions by conducting a qualitative patient-led peer to peer study which will inform the development of an IBD patient and HCP survey.

Methods

IBD patients (≥ 18 years of age) were recruited through the IBD clinic at the University of Calgary and via social media. Focus groups were held in three separate provinces (British Columbia, Alberta and Ontario) in both rural and urban locations. The focus groups were facilitated by a Patient Engagement Researcher to alleviate any potential power dynamics and to create a safe space for IBD patients to share their perspectives. A participatory action research approach was used to encourage co-production with participants throughout the focus groups. The focus groups were audio recorded. Flip charts and sticky notes were used for brainstorming and prioritization exercises. All audio and written data were transcribed. Thematic analysis was used to identify emerging themes and patient priorities.

Results

A total of 21 participants attended the focus groups from both rural and urban locations. Participant diversity ranged in ethnicity and age. Most of the participants were female (18 females and 3 males) of which 4 were biologic naïve and 17 were biologic exposed. The Top 5 IBD Patient Priorities when making treatment decisions are 1) Risks(more serious/long term) 2) Education(Support/Evidence Based Information/Resources) 3) Side Effects(short term/less serious) 4) Efficacy 5) Impact(Quality of Life/ Lifestyle/Logistics).

Conclusions

Co-producing research ‘with’ and ‘by’ IBD patients helped to generate priorities that matter most to patients when making treatment decisions. The patient priorities will help in the development of an IBD Patient and HCP survey. The results from the two surveys will be compared to understand patient vs. HCP perspectives.
P018 INTERNET DIETS: ONLINE INFORMATION REGARDING NUTRITIONAL TREATMENTS FOR IBD
Authors: Baumgartner Scott , Rao Vinay , Khan Ali , Borum Marie
Published: January 2020

Background

Nutrition is a vital component in the management of IBD and can be an effective primary therapy for many patients. Certain types of diets, including the Western diet, have been speculated to be associated with increased IBD risk or exacerbations. There are currently no specific dietary recommendations for IBD risk reduction. However, online resources may offer nutritional guidance to patients seeking information. This study evaluated specific nutritional and dietary treatment information for IBD on the Internet.

Methods

Google search engine was used to query “nutrition and inflammatory bowel disease” to obtain the first 100 websites. Websites that were non-accessible, duplicates, videos without transcripts, or evaluated animal models were excluded. Websites were categorized as informational or academic/professional. Websites were reviewed for discussion of specific nutritional treatments, acknowledgement of areas of uncertainty and references. Statistical analysis was performed using a two-tailed Fisher’s Exact Test with a significance value set at p <0.05.

Results

89 (50 informational, 39 academic) met the inclusion criteria. No websites were commercial or personal. 49 (55%) websites discussed nutrition as a treatment modality. Enteral nutrition was discussed in 38 (77.6%), probiotics in 22 (44.9%), parenteral nutrition in 21 (42.9%), elimination diet in 19 (38.8%), and low FODMAP diet in 15 (30.6%). Academic resources discussed specific nutritional therapy more often than informational resources (82.1% and 45.0%, respectively; p=0.003) (Figure 1). Academic resources acknowledged areas of uncertainty more frequently than informational resources (64.1% and 30.0%, respectively; p=0.024). Academic resources cited references significantly more often than informational resources (80.9% and 10.6%, respectively; p<0.0001).

Discussion

This study shows that the most commonly discussed nutritional therapy was enteral feedings (77.6%), followed by probiotics (44.9%), parenteral feeding (42.9%), elimination diet (38.8%), and the low FODMAP diet (30.6%). Academic websites discussed dietary options significantly more than informational websites. These results suggest that there is a paucity in consumer-oriented literature regarding nutrition in IBD. Academic websites are the primary online resources for information about nutrition in IBD, discuss areas of uncertainty, and offer references. As patients with IBD are increasingly utilizing the Internet for recommendations regarding disease management, it is important that both academic and informational online IBD resources provide comprehensive nutritional information to enhance patient education.

Reference
P020 PRACTICE PATTERNS OF PRIMARY CARE AND GASTROENTEROLOGY PHYSICIANS IN THE MANAGEMENT OF IRON DEFICIENCY ANEMIA IN INFLAMMATORY BOWEL DISEASE
Authors: Wade Francis , Odufalu Florence-Damilola , Grosch Gretchen , Chambers Melissa , Schroeder Katie
Published: January 2020

Introduction

Iron deficiency Anemia (IDA) is a common complication of inflammatory bowel disease (IBD). High prevalence of IDA in IBD suggests suboptimal surveillance and treatment. Oral iron is poorly tolerated, associated with worsened disease activity, and often insufficient to reverse anemia in IBD patients. Intravenous (IV) iron is favored for treatment of IDA in IBD in most clinical scenarios and many guidelines recommend IV iron as first line for IBD patients. Regardless, oral iron is prescribed commonly for IDA in IBD. The objective of this study is to determine practice patterns of primary care physicians (PCP) and gastroenterologists (GI) in the management of IDA in IBD.

Methods

We anonymously surveyed GI and PCP attendings and trainees at Saint Louis University School of Medicine in St. Louis, Missouri, using paper self-administered instruments. We asked about practice patterns in the management of IDA in IBD patients and knowledge of IV iron. The study questionnaire was developed based on United States expert opinion consensus statements and European guideline recommendations published in the Journal of Crohn’s and Colitis and Inflammatory Bowel Diseases.

Results

Of GI responders, 92.3% were fellows, 7.7% were attendings; of PCP responders, 81.8% were residents, 18.2% were attendings. 15.4% GIs, 12.7% PCPs were very comfortable managing IBD patients with IDA; 76.9% GIs, 58.2% PCPs were somewhat comfortable; 7.7% GIs, 29.1% PCPs were not comfortable (p=0.275). 61.5% GIs, 25.5% PCPs always check iron studies when evaluating anemic IBD patients; 30.1% GIs, 21.8% PCPs check most of the time; 7.7% GIs, 34.5% PCPs sometimes check; 0% GIs, 12.7% PCPs rarely check; 0% GIs, 5.4% PCPs never check (p =0.05). In mild Crohn’s disease with severe anemia, 15.4% GIs, 41.8% PCPs would prescribe oral iron daily; 15.4% GIs, 12.7% PCPs would prescribe oral iron every other day; 69.2% GIs, 45.5% PCPs would prescribe IV iron (p=0.58). 0% GIs reported good knowledge of IV iron, 53.8% reported acceptable knowledge, and 46.1% reported poor knowledge. 7.7% GIs, 10.9% PCPs reported good knowledge of how to order IV iron; 53.8% GIs, 7.3% PCPs reported acceptable knowledge; 38.5% GIs, 81.8% PCPs reported poor knowledge (p=0.000215). 23.1% GIs, 61.8% PCPs thought PCPs were responsible for screening for IDA in IBD patients; 76.9% GIs, 36.4% PCPs thought GIs were responsible (p= 0.0131).

Discussion

Both PCPs and GIs perceived responsibility to manage IDA in IBD patients. PCPs were less likely than GIs to screen for IDA in anemic IBD patients or to report adequate knowledge of clinic processes to order IV iron. Future efforts to reinforce gastroenterologists’ role in the management of IDA in IBD and to bolster familiarity with IV iron and its indications might improve outcomes and quality of life for IBD patients.
P023 THE ASSOCIATION BETWEEN BIOLOGIC USE AND SPECIMEN LENGTH IN CROHN’S DISEASE
Authors: Wood Trevor , Zaghiyan Karen , Fleshner Phil
Published: January 2020

Introduction

Despite advances in medical management, including the use of biologic agents, up to 80% of Crohn’s patients (CD) ultimately require operative intervention. Additionally, these patients are at risk for additional operative intervention within their lifetime. Given the risk of short bowel syndrome secondary to multiple bowel resections, conservation of bowel length is of paramount importance. A common yet unproven belief in the gastroenterology community is that intensive preoperative medical therapy might reduce the length of bowel removed at surgery. In this study, we compared specimen length in CD patients treated or not treated with biologic agents before surgery.

Objective

To determine if there is an association between biologic use and reduced specimen length after bowel resection.

Methods

Prospectively generated clinical profiles on consecutive CD patients undergoing their first ileocolic or small bowel resection between November 1999 to July 2019 were reviewed. Patients were classified into 2 groups: Group A patients were treated with biologic agents at any time before surgery while Group B patients had never received a biologic agent. Specimen length was determined by review of pathology reports. In patients with multi-segment resections, the sum of the specimens was recorded. The means of the two groups were compared using Students t test.

Results

The study cohort of 392 patients had a mean age of 36.2 (SD 15.9) years and included 53% males. Group A included 247 (63%) patients and Group B included 145 (37%) patients. Groups were comparable in terms of background demographics with the exception of age, use of preoperative immunomodulator therapy, and medical intractability as an indication for surgery (p value 0.01, <0.01, 0.02 respectively) The mean specimen length in Group A was 29.1cm compared to 29.9cm in the Group B (p=0.68). A subgroup analysis of ileocolic resections and small bowel resections was completed. Within the ileocolic group, there was no significant difference in length between groups with respect to the total specimen length (p=0.92), colonic portion (p=0.15), and small bowel portion (p=0.67). Analysis of small bowel resection specimens also found no difference in length between the groups (p=0.63).

Conclusions

The use of biologics in CD was not associated with reduced specimen length in ileocolic resections and in small bowel resections
P029 VTE RISK WITH IBD PLUS ORAL CONTRACEPTIVES: ARE PATIENTS AWARE?
Authors: Dave Jenny , Chawla Karan , Carro-Cruz Francis , Rao Vinay , Gibilisco Jessica , Baumgartner Scott , Negreira Katherine , Borum Marie
Published: January 2020

Background

The risk of venous thromboembolism (VTE) is 1.5–3 fold higher in individuals with IBD compared to the general population. In addition, combination hormonal oral contraceptives (OCPs) are associated with a 3–5 fold increase in VTE. However, there is limited data regarding VTE risk in women with IBD who are on OCPs. It is speculated that women with IBD who may be at increased risk for VTE occurrence are not consistently counselled about VTE risks. This study evaluated the rate of VTE counselling in reproductive aged women and those on oral contraceptives.

Methods

A retrospective medical record review of all IBD women seen at a university gastroenterology practice during a 5 year period was performed. Patients’ age, disease type, OCP use and VTE risk counseling were obtained. A database was created maintaining patient confidentiality. Analysis was conducted using Fisher’s Exact Test with significance set at p< 0.05. The study was approved by the university IRB.

Results

There were 209 female IBD patients with a mean age of 44 years (range 23–82). 153 had ulcerative colitis, 53 had Crohn’s disease and 3 had indeterminate IBD. Self-reported ethnicity included 93 White, 67 Black/African-American, 7 Asian, 1 Hawaiian, 19 other and 22 declined reporting their ethnicity. There were 146 women of reproductive age (<50 years) and 63 women >50 years. 7 women, all age <50, were counselled about potential VTE risk. There was no significant difference (p=0.105) in the rate of VTE counselling in women based upon age. In the 24 women of reproductive age who were on OCPs, one patient was counselled about increased VTE risk. There was no significant difference (p=1.00) in the rate at which women of reproductive age on OCPs (1 in 24, 4.2%) were counselled compared to women of reproductive age who were not on OCPs (6 in 122; 4.9%).

Discussion

Venous thromboembolism can result in significant morbidity and mortality. Individuals with IBD are at increased risk for VTEs. Women with IBD on oral contraceptives may be at greater risk for VTEs than other IBD patients. This study revealed that IBD women infrequently receive education about VTE risk. There was no significant difference in the rate of counselling in women based upon age. There was also no significant difference in the VTE counselling in women of reproductive age who were on OCPs compared to those who were not on OCPs. Whle this study is limited based upon single institutional design, retrospective evaluation and small sample size, it offers important information for further study and educational initiatives. Enhanced efforts to educate individuals about the risk for VTEs can improve IBD management and outcomes.
P034 A QUALITATIVE STUDY EXPLORING THE BURDEN OF CROHN’S DISEASE AMONG CHILDREN AND ADOLESCENTS
Authors: Coskun Ufuk , Kelly Kim , Hunter Theresa , Newton Louise , Symonds Tara , Delbecque Laure
Published: January 2020

Background

Crohn’s disease (CD) is a type of inflammatory bowel disease that can occur at any age, though is most common between ages 15–35 years. CD symptoms can have a significant impact on health-related quality of life (HRQL). Although key symptoms and impacts of CD in adults are well-known, exploration of these in children and the level of agreement between child reported symptoms and impacts and those observed by parents/caregiver have not been well documented.

Objectives

Understand patients’ experiences of CD, including CD symptoms and the burden of living with CD, from the perspective of CD child and adolescent participants and parents/caregivers of children with CD.

Methods

Children (ages 5–11 years) and adolescents (ages 12–17 years) with CD and parents/caregivers of children with CD (ages 2–11 years) were recruited from US clinical sites. Qualitative semi-structured interview guides were developed, informed by published literature. Face-to-face and telephone concept elicitation interviews were conducted, audio-recorded and transcribed. Transcripts were analyzed using thematic methods facilitated by Nvivo.

Results

A total of 43 participants participated in this study. Preliminary results showed that pain, frequent bowel movements, diarrhea, and tiredness were spontaneously discussed by ≥60% of the participants, while blood in stool, cramping in abdomen, urgent bowel movement, nausea, and low appetite were spontaneously discussed by ≥30% of the participants. More than 15 other symptoms such as joint issues, abscess/fissures, and hives/rashes were each mentioned by at least one participant. In addition, ≥50% of the participants discussed impacts related to CD including school attendance, exercise/sports, eating and drinking limitations, and play and leisure.

Conclusions

The results from CE interviews demonstrate the clear burden of CD on children and adolescents.
P035 ADJUNCT PHARMACOTHERAPY USE FOR POUCH-RELATED SYMPTOMS IN PATIENTS WITH ILEAL POUCH-ANAL ANASTOMOSIS
Authors: Nyabanga Custon , Axelrad Jordan , Zhang Xian , Barnes Edward , Sandler Robert , Chang Shannon
Published: January 2020

Background

For patients with recalcitrant ulcerative colitis or indeterminate colitis, surgical intervention with restorative proctocolectomy and ileal pouch-anal anastomosis (IPAA) has become the standard of therapy. The most common complication after IPAA is pouchitis, which may manifest with pouch related symptoms (PRS) such as increased bowel frequency, abdominal pain, pelvic pain, urgency, or incontinence, necessitating use of adjunctive pharmacotherapies for symptom control. We evaluated the prevalence of opioid-, NSAID-, and probiotic-use among IPAA patients with and without PRS.

Methods

Utilizing patient questionnaires from the IBD Partners database cohort of patients with IPAA, we examined baseline characteristics, antibiotic and biologic use, adjunct pharmacotherapy use, and patient reported outcomes (PROs) including bowel frequency, urgency of defecation, and general well-being. We used specific Patient-Reported Outcome Measurement Information System (PROMIS) measures (measured in T-scores) to assess abdominal pain and depression. Bivariate analysis of baseline demographics and medication use patterns was performed to compare IPAA patients with PRS and without PRS. Among patients with PRS, PROs were compared among opioid, NSAID, and probiotic users.

Results

We identified 363 patients with IPAA patients in the IBD Partners database, and 266 (73%) reported PRS within 6 months of completing their last survey. In comparison to those without PRS, patients with significant PRS had a shorter time since diagnosis of IBD (P = 0.015), higher prevalence of antibiotic use (P < 0.05), higher rectal steroid use (P = 0.003), and more prevalent adalimumab use (P = 0.041). Among patients with PRS, there were no significant differences in PROs based on NSAID or probiotic usage. However, opiate users with PRS noted increased bowel frequency, urgency of defecation, poor general well-being, abdominal pain, and depression (P < 0.05 for all variables).

Conclusion

Among IBD patients with IPAA with PRS, the use of NSAIDS and probiotics was not associated with differences in PROs. Opioid use was associated with higher burden of PRS, but further studies will be required to elucidate association or causality.
P039 CLINICAL HYPNOSIS IN PEDIATRIC CROHN’S DISEASE: A RANDOMIZED CONTROLLED TRIAL
Authors: Lee Amanda , Moulton Dedrick , Acra Sari , Walker Lynn , Mckernan Lindsey , Russell Alexa
Published: January 2020

Background

Crohn’s disease (CD) is a chronic, immune-mediated condition associated with abdominal pain, psychological comorbidities, and reduced quality of life (QoL), even in remission. Clinical hypnosis, involving focused relaxation and therapeutic suggestion, is helpful for irritable bowel syndrome, pain, and anxiety, and may have anti-inflammatory effects. Study Aims: To implement hypnosis as an adjunctive therapy for adolescents with CD. To assess the impact on QoL, abdominal pain, psychosocial measures, and disease activity compared to standard care.

Methods

Forty 12–18 year-olds with CD diagnosed >3 months prior randomized to hypnosis intervention (HI) or waitlist control (WC). HI receive one in-person hypnosis session focused on enhancing comfort, calm, and energy; education on self-hypnosis; audio recordings for 8 weeks home practice. Assessments at 8 and 16 weeks. Primary outcome: disease-specific health-related (HR) QoL Impact III, single-item QoL modified Cantril Scale, parent-proxy HRQoL PedsQL 4.0. Secondary outcomes: Anxiety, Depressive Symptoms, Sleep Disturbance (PROMIS pediatric short forms); abdominal pain frequency and intensity; Pain Beliefs Questionnaire short form (PBQ-SF); school absences; healthcare utilization; Physician’s Global Assessment (PGA); Pediatric Crohn’s Disease Activity Index. With n=40, 80% power to detect 13-point difference in Impact III. Two-sided Wilcoxon test used to compare differences from baseline to follow up and between groups.

Results

Demographics: 40 participants enrolled February-May 2019. 50% female. 15.8 y ± 2. PGA: 28 quiescent, 6 mild, 3 moderate, 3 not documented. 18, 8, and 13 of 40 with moderate-severe depressive symptoms, anxiety, and sleep disturbance, respectively. 25 of 40 with abdominal pain in the past week. WC with poorer systemic symptom-related QoL by Impact III (p=0.01) and greater depressive symptoms (p=0.03) compared to HI. Post-Intervention (8 Weeks): In HI and not in WC, significant improvement was noted in parent-reported QoL (p=0.006; Figure 1), maximum abdominal pain intensity (p=0.01, Figure 2), PBQ-SF subdomain emotion-focused coping efficacy (p=0.04), and school absences (p=0.03). 50% of HI participants used self-hypnosis at least 3–4 times per week and tended to have greater QoL improvement than those who practiced less. Participants described improvement in stress, anxiety, and sleep, though corresponding measures were unchanged. 16-week outcomes and disease activity pending.

Conclusions

Adolescents with CD have pain, reduced QoL, and psychological impairment despite inactive disease. Hypnosis is an acceptable, feasible, and promising complementary therapy in CD and may improve QoL, abdominal pain, coping efficacy, and school attendance. Additional RCTs with longer follow up, objective disease activity assessment, and measures to improve compliance are warranted.
P051 USING A HUMAN-CENTERED QUALITATIVE RESEARCH APPROACH FOR DEVELOPING IBD EDUCATIONAL VIDEOS DELIVERED THROUGH SOCIAL MEDIA
Authors: Khalil Carine , van Deen Welmoed , Dupuy Taylor , Bonthala Nirupama , Almario Christopher , Spiegel Brennan
Published: January 2020

Background

Patients with inflammatory bowel disease (IBD) can have knowledge gaps regarding their disease and its management, which may lead to anxiety and reduced quality of life. They often use social media as a tool to seek information and manage their chronic disease. The goal of this study was to develop a series of educational videos optimized for social media that are informed by patient insights and address their experiences, concerns, and unmet educational needs.

Methods

We used a human-centered design approach to guide our qualitative data collection and analysis. We performed two focus groups and 6 semi-structured interviews with patients with IBD to gain insights into their educational needs and expectations regarding these videos. In total, 19 patients with diverse demographic profiles and varying health and digital literacy levels were included in our purposive sample. The collected data was transcribed and analyzed using a thematic analysis. We visualized patients’ thoughts, feelings, and needs in an empathy map. The mapping process helped us create a shared understanding of patient-users, and generate ideas on the topic and the script of each video. Subsequently, 5 video prototypes were built and tested by 22 patients with IBD. The collected feedback was used to refine the prototypes and develop the final videos.

Results

We noted conflicting thoughts and feelings towards online information; on one hand, IBD-related online information was perceived as overwhelming and unreliable, but on the other it was empowering and helpful. Five major themes for the video topics also emerged from the analyses (Figure 1). First, patients noted a major need to learn about the risks and benefits associated with available treatment options. Participants expressed concerns regarding starting biologics, biologics side-effects and long-term effectiveness. Second, they accentuated the need to know how to be self-advocates in order to navigate their insurance and to obtain the information they need from their providers. Third, they mentioned the importance of learning ways to stay healthy beyond just medical therapy. Fourth, they wanted information on how to cope with their IBD diagnosis and live with their condition. Fifth, participants expressed desire for a video that educates their families, friends and colleagues about IBD, so that they can better understand IBD patients’ psychological and physical experiences.

Conclusion

We used a human centered qualitative approach to get an in-depth understanding of IBD patients’ educational needs, thoughts and feelings. A series of focus groups and interviews were performed with patients, which informed the development of 5 educational videos that are tailored to suit their needs. In the next phases of this study, the videos will be formally tested and widely disseminated through social media.
22 CHANGE IN FECAL CALPROTECTIN AND LACTOFERRIN PREDICT CLINICAL REMISSION FOLLOWING INDUCTION THERAPY WITH INFLIXIMAB IN PEDIATRIC CROHN’S DISEASE (CD)
Authors: Colman Ruben , Boyle Brendan , Noe Joshua , Hyams Jeffrey , Minar Phillip
Published: January 2020

Background

The fecal biomarkers, calprotectin and lactoferrin are noninvasive biomarkers for mucosal inflammation in IBD. While prior cross-sectional studies showed a correlation between these measures, less is known about the relationship of these measurements with treatment response over time. We aimed to assess the correlation between and utility of fecal calprotectin and lactoferrin on treatment response with infliximab (IFX).

Methods

We analyzed fecal calprotectin (FCP) and lactoferrin (LCT) as part of a multicenter, prospective anti-TNF induction cohort. IFX induction between 5-10mg/kg occurred at 0, 2 and 6 weeks. Stool and serum were collected prior to IFX treatment (baseline) and during follow-up. We evaluated FCP, LCT and trough IFX levels prior to the first and at subsequent infusions up to infusion 4. The primary outcome was the correlations between FCP, LCT, and outcomes at maintenance. Clinical outcomes were assessed by the wPCDAI measured at each infusion. Clinical remission was defined as wPCDAI <12.5. Spearman correlation was used to assess the relationship between FCP and LCT. Predictive outcomes were calculated by receiver operating characteristics (ROC) with Youden-J statistic.

Results

Among 57 CD patients, 54 (95%) had FCP and LCT measured at both baseline and infusion 4. There was a strong correlation between calprotectin and lactoferrin with data at all time points (R = 0.82, P < 0.0001). The correlation was even stronger at infusion 4 (R = 0.88, P < 0.0001). A delta score for FCP and LCT was calculated by the proportional change between baseline levels to infusion-4 levels. There was a strong correlation between the FCP delta and LCT delta (R = 0.7, P < 0.0001), suggesting similarities in quantifiable change over time. At Infusion 4, an FCP < 378 μg/g predicted sustained clinical remission between week 14 and 6 months with a sensitivity (sens) of 71% and specificity (spec) of 58% (AUC 0.708; P = 0.01). LCT <20.5 μg/g predicted sustained clinical remission between week 14 and 6 months with a sens of 68% and spec of 45% (AUC 0.627; P = 0.117). FCP < 639 μg/g at infusion 4, had a sens of 75% and spec of 75% for achieving an infusion 4 trough level ≥ 5μg/ml (AUC 0.758; P = 0.005). LCT < 34.2 μg/g had a sens of 69% and spec of 54% (AUC 0.692; P = 0.036) for similar trough levels. FCP < 213.6 μg/g at infusion 4, had a sens of 56% and spec of 88% for achieving a infusion 4 trough level > 8μg/ml (AUC 0.744; P = 0.007). LCT < 6.0 μg/g had a sens of 44% and spec of 92% (AUC 0.675; P=0.05) for similar trough levels.

Discussion

This study demonstrates that both noninvasive biomarkers can be used to predict sustained clinical remission during IFX therapy. It also provides further evidence for the utilization of fecal calprotectin and lactoferrin as predictors to achieve IFX infusion 4 trough level targets for ≥ 5μg/ml and >8μg/ml.
P086 EFFECTIVENESS OF VEDOLIZUMAB IN PATIENTS WITH REFRACTORY IMMUNOTHERAPY-RELATED COLITIS: A CASE SERIES
Authors: Harris Jessica , Faleck David
Published: January 2020

Intro

Immune checkpoint inhibitors (ICIs) have become a new standard of care in several cancers but often lead to undesirable immune-related adverse effects, including GI toxicity in up to 1/3 of patients. ICI-related colitis (irColitis) is generally treated with immunosuppressive medications such as steroids, but may be refractory in up to 50% of cases and require further treatments such as infliximab. The role of vedolizumab (VDZ), a newer gut-selective agent approved for inflammatory bowel disease (IBD), remains unclear.

Methods

We describe a retrospective study of all patients treated with VDZ for irColitis at a tertiary care cancer center in New York City between 2018–2019. Clinical response was defined as initial improvement in diarrhea to CTCAE Grade ≤1. Sustained remission was defined as resolution of diarrhea with no further flares within 30 days.

Results

Eleven patients were treated with VDZ during this time period. Patients were followed for a median of 11.6 months from the time of ICI initiation. Two patients with pre-existing IBD (ulcerative colitis n=1, lymphocytic colitis n=1) with prior severe irColitis were started on VDZ as a steroid-sparing agent (n=1) and prophylaxis during ICI re-challenge (n=1). Both patients’ colitis remained in remission without further flares.

Nine patients were treated with VDZ for steroid-refractory irColitis, seven (78%) of whom had already failed at least one TNF inhibitor. VDZ was started a median of 76 (IQR 72–124) days after onset of colitis and patients were treated with a median of 2 (IQR 2–5) doses. The median time to initial clinical response after starting VDZ was 7 (IQR 5–14) days. Six (67%) achieved sustained remission with VDZ after a median of 15 (IQR 5–43) days. Two (22%) of patients were refractory to both infliximab and VDZ therapy and required further salvage with fecal microbiota transplantation and/or surgery. Median total steroid duration was 80 (IQR 52–108) days, and median duration from onset until final resolution of colitis was 126 (IQR 51–133) days.

Conclusion

In this series of patients with refractory irColitis, VDZ treatment led to successful resolution of colitis in the majority of patients, with sustained remission achieved generally after 1–2 doses. Prospective studies are needed to further elucidate the role of VDZ in the treatment of irColitis.

Patient Demographics

Immune-Related Colitis Treatment
P087 REAL-WORLD EFFECTIVENESS OF USTEKINUMAB IN ULCERATIVE COLITIS
Authors: Hong Simon , Zullow Samantha , Axelrad Jordan , Chang Shannon , Hudesman David
Published: January 2020

Introduction

Ulcerative colitis (UC) is a chronic inflammatory condition of the colon. Ustekinumab is a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23 FDA approved for use in Crohn’s disease. A recent randomized control trial UNIFI [Sands et al, NEJM 2019] demonstrated the efficacy of ustekinumab in patients with moderate-to-severe UC. The goal of this study was to describe the real-world effectiveness of ustekinumab in patients with UC.

Methods

A retrospective, single-center, chart review was performed of all patients with UC who received ustekinumab between January 2017 and October 2019. As ustekinumab is not yet FDA approved for UC, for patients who have exhausted other treatment options its use is considered “off-label”. Patient demographics, disease characteristics and prior treatment history were recorded. The primary outcome was clinical remission at 12 months after initiation of ustekinumab. Secondary outcomes were clinical response and remission at 3 months, and endoscopic response, corticosteroid-free remission, and deep remission (combined clinical and endoscopic remission) at 12 months (all outcomes defined in Figure 1).

Results

19 pts received ustekinumab for moderate-to-severe UC. They were 47.4% male with a mean age of 42.7 ±17.0 years. Mean total Mayo score was 7.6 ± 1.5 and 47.4% of pts had disease limited to the left colon. 18/19 pts received a weight-based IV induction dose (520 mg, 390 mg or 260 mg for > 85 kg, >55 to 85 kg or ≤55 kg respectively) and 1/19 received 90mg subcutaneous injection as induction. All pts received 90mg subcutaneous injections every 8 weeks initially for maintenance, and 9/19 eventually needed dose escalation to every 4 weeks. All pts had prior exposure to a TNF antagonist, 26.3% had exposure to two or more TNF antagonists, 89.5% had prior failure of vedolizumab and 10.5% had prior failure of tofacitinib (Table 1). At 12 months, 38.5% had a clinical response, 30.8% were in clinical remission, 38.5% had an endoscopic response, and 30.8% were in deep remission (Figure 1). Two infectious adverse events (shigellosis, Escherichia coli enterocolitis) were reported in follow-up.

Conclusions

Ustekinumab is effective in patients with UC. The efficacy of ustekinumab in the UNIFI trial translated to our real-world population, despite higher rates of prior biologic failure with TNF antagonists and vedolizumab in our cohort. Further studies of large, real-world cohorts are needed to assess the long-term effectiveness and safety of ustekinumab in UC.
P090 SAFETY AND EFFICACY OF COMBINING BIOLOGICALS IN CHILDREN WITH INFLAMMATORY BOWEL DISEASE
Authors: Goyal Alka , Bass Julie
Published: January 2020

Background and Aims

Inflammatory bowel disease (IBD) is a chronic inflammatory condition requiring treatment with lifelong immunosuppressive treatment. Up to 30% of the patients do not respond to standard medical therapy. There is limited data on the use of combining two biological agents in medically refractory patients. Our aims were to review patients who received two biological agents concurrently for at least 4 weeks or longer to assess for safety and efficacy of this approach.

Methods

We performed a retrospective study on patients (1–22 years old) being treated at Children’s Mercy Kansas City for IBD who were placed on a combination of two biological agents concurrently for medically refractory disease. Charts of eligible patients were reviewed to abstract demographics, Paris classification, extraintestinal manifestations, concomitant morbidities, drug therapy, surgeries, disease activity scores, outcomes and adverse events related to therapy.

Results

Nine patients with a median age of 16 (8–19 years) were found to be eligible. Eight were Caucasians and one was of African American origin. Eight patients were diagnosed with Crohn’s disease (CD), and one was thought to have ulcerative colitis (UC) but later found to have CD. Two had celiac disease, 2/9 had growth failure, one each had arthritis and sacroiliitis. Two had ileo-anal pouch and one patient had recurrent macrophage activating syndrome. Indications included partially responsive luminal disease(7), pouchitis (2), perianal fistulizing disease (2), sacroiliitis (1). Five patients were also on an immunomodulator at the time of combination therapy. Only one patient received Anakinra with infliximab whereas rest were on combination of either infliximab or adalimumab with vedolizumab. Four patients achieved remission, two were unresponsive, one had improvement in growth only and two had partial response. One patient developed staphylococcal skin infection but there was no other therapy related adverse events.

Conclusions

Combination of two biological agents is safe. Further studies are needed to determine the utility of this approach.