scholarly journals P614 A strategy to solve complexity of physician diagnosis using a mixture of Patient Reports and Provider Reports: A Case Study of Crohn’s Disease Phenotypes

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S557-S558
Author(s):  
L Zhang ◽  
Y Fan ◽  
J Thompson ◽  
R Bohn ◽  
O Negar ◽  
...  

Abstract Background The IBD Plexus® Registry, established by the US Crohn’s & Colitis Foundation, combines patient and provider reported survey data collected from doctors’ visits and historical data in electronic medical record (EMR) systems. This multi-resource dataset presents data discrepancies in assessing phenotypes of Crohn’s disease (CD). The aim of this analysis is to describe a strategic process to solve data challenges related to CD phenotype definitions based on the IBD Plexus data. Methods This cross-sectional, multicenter, US based study used data from 11/2016 to 06/2020 from the IBD Plexus® Sparc program to assess demographics, symptoms and treatments among CD patients. Data discrepancies between CD phenotype status reported and as described in historical EMRs were identified. Physicians may use the Montreal classification with/without the Paris modification for phenotype evaluation. To resolve this discrepancy, we explored and evaluated several study phenotype definitions: 1) using phenotypes at visits, the registry suggested method; 2) using phenotype and history of fistula/abscess or stricture in EMR; and 3) using definition 2 without anal stricture. The implementation included two steps: 1) severe conditions (penetrating, stricturing or both) were considered irreversible and defined using the data at any time before 30 days after the registry consent date; 2) the inflammatory condition was positive in the absence of any other reported severe condition during the entire study period. Results The frequency results by phenotypes show small differences across definitions (Figure 1). The discrepancy in frequency by definition1 demonstrated the phenotypes recorded at visits contradicted phenotypes in the EMR. For instance, 0.1%-3.2% or 0.1–0.7% of CD inflammatory patients had subtypes of stricture and subtypes of fistula/abscess, respectively. About 0.5% of CD stricturing patients had intra-abdominal abscess or other fistula (Figure 2). Among CD penetrating patients, 32.0% had history of ileal stricture (Figure 3). Including EMR phenotype variables in definition 2, all discrepancies were resolved. With verification, anal strictures are due to perianal disease which should not be used in the stricturing definition; therefore, the anal stricture was exempt from definition 3. All subtype phenotypes showed 0% discrepancy with study phenotype. A small percentage of positive anal stricture patients was allowed in definition 3. Figure 1. Figure 2. Figure 3. Figure 4. Conclusion When handling the mixture of patient reported and provider-reported data, data discrepancies have many causes. Clarifying the clinical rationale is a key process to resolve discrepancies and accurately define measures of interest.

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S005-S006 ◽  
Author(s):  
B Pariente ◽  
J Torres ◽  
J Burisch ◽  
N Arebi ◽  
B Barberio ◽  
...  

Abstract Background The Lémann index (LI) is the first instrument developed to measure cumulative structural bowel damage in Crohn’s disease (CD).1 We here report its validation. Methods This was an international, multicentre, prospective cross-sectional observational study. At each centre, 10 inclusions, stratified by known or suspected CD location and duration, were planned. Clinical examination and abdominal MRI had to be performed in all patients, and upper endoscopy, colonoscopy, and pelvic MRI according to CD location. Upper tract (UT), small bowel (SB), colon/rectum (CR), and anus (AN) were divided into 3, 20, 6 and 1 segments, respectively. History of previous surgery was collected per segment. For each segment, 1 gastroenterologist and 1 radiologist per centre, identified the presence of predefined stricturing and/or penetrating lesions of maximal severity (grade 1 to 3) at each investigation. They provided a damage evaluation for each non-resected segment ranging from 0 to 10, 10 corresponding to the damage of a completely resected segment. Investigator organ damage evaluation was calculated as the sum of segmental damage evaluations. Finally, investigators provided a global damage evaluation from 0 to 10 for each patient according to the 4 organ damage scores, calculated as a function of investigator organ damage evaluations, resections and a total number of segments. The correlation between the investigator global damage evaluation and the LI was high on the construction sample, since coefficients to derive the LI were estimated by maximising this correlation, and is expected to be lower on data obtained in new patients by new investigators. Thus, the LI would be validated if the linear regression model of investigator global damage evaluation on LI shows a still high correlation. The same applies to investigator damage evaluation of each organ and each organ component of the LI. Results 134 patients were included in 15 centres, 7 to 10 per centre. Correlation coefficients between investigator organ damage evaluation and each organ component of the LI were 0.91, 0.96, 0.95, and 0.81, for UT, SB, CR and AN, respectively. The correlation coefficient between investigator global damage evaluation and the LI was 0.98 (Figure 1). Proportions of the investigator organ damage evaluation variance explained by each organ component of the LI were 82%, 91%, 89%, 65%, for UT, SB, CR, AN, respectively. This proportion was 96% for the investigator global damage evaluation and the LI. Conclusion The Lémann index is now a validated index to assess cumulative bowel damage in CD that can be used in epidemiological studies and disease modification trials. Reference


2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S13-S13
Author(s):  
Jamison Seabury ◽  
Christine Zizzi ◽  
Jennifer Weinstein ◽  
Ellen Wagner ◽  
Spencer Rosero ◽  
...  

Abstract Background Patients with Crohn’s disease experience a wide variety of clinical symptoms that affect how they feel and function. As therapeutic trials are planned for patients with Crohn’s disease, it is important to better understand the symptoms that have the greatest impact on Crohn’s disease patient’s lives. Objective To identify the most common and important disease manifestations in Crohn’s disease in a large population of patients. To determine the modifying factors that are associated with these symptoms. Methods We conducted a national cross-sectional study of 415 patients from the IBD Partners patient registry sponsored by the Crohn’s & Colitis Foundation to identify the prevalence and relative importance of 148 individual symptoms across 17 unique symptomatic themes. These themes were previously identified through 16 semi-structured qualitative interviews with Crohn’s patients. Results Crohn’s disease participants provided over 55,000 symptom rating responses. The symptomatic themes with the highest prevalence in Crohn’s disease were gastrointestinal issues (93.0%), fatigue (86.4%), dietary restrictions (77.9%), impaired sleep or daytime sleepiness (75.6%), and inability to do activities (72.3%). Symptomatic theme prevalence was widely associated with having above the median number of stools per day, having above the median number of bowel movements per day, having perianal disease, having to miss work, and unemployment. Discussion/Conclusion: Crohn’s disease symptoms, some under-recognized, vary based on disease characteristics and demographic features. These symptoms represent targets for future therapeutic interventions and are potential areas of interest for an upcoming disease-specific patient-reported outcome measure for this population. Acknowledgements Funding for this project was provided by UR Ventures. Research activities were conducted in collaboration with the Crohn’s & Colitis Foundation.


2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S2-S2
Author(s):  
John Marston ◽  
J C Chapman ◽  
Diana Hamer

Abstract Introduction Brodie’s abscess is an uncommon variant of subacute osteomyelitis leading to a contained infectious focus within a bone. It classically occurs in young people with a history of trauma to the affected bone. We present a case of a Brodie’s abscess in a 52-year-old Crohn’s patient on dual immunosuppressive therapy. Case Description A 52 year old man with Crohn’s disease managed with adalimumab and methotrexate presented to an orthopedist with worsening left hip and thigh pain and fevers over the week prior. He reported a remote sports-related injury to the same region with mild pain intermittently over the subsequent years. MRI of the left pelvis showed an enhancing lesion of the anterior superior iliac spine with cortical erosion. He was admitted and started on broad spectrum antibiotics, and his immunosuppressive agents were held. CT-guided biopsy of the lesion returned as abscess, and culture of the lesion grew methicillin-sensitive staphylococcus aureus. The abscess was debrided in the OR and he completed a 6-week course of culture-guided antibiotic therapy. Discussion To our knowledge this is the first reported case of Brodie’s abscess associated with Crohn’s disease and dual immunosuppressive therapy. Opportunistic pathogens are most often associated with anti-TNFα therapy, though there is also evidence other bacterial infections are more frequent in these patients, particularly salmonellosis, listeriosis, and pneumococcal disease. Patients on anti-TNFα therapy appear to be at highest risk for serious infections in the first six months after initiation, but it is unclear if there is a persistent or cumulative risk with long-term therapy. The underlying mechanism of immunosuppression in anti-TNFα therapy is thought to be multifactorial, impacting both innate and adaptive immunity. Data suggests increased risk of infection in rheumatoid arthritis patients taking methotrexate. Only observational data exists regarding infection risk in Crohn’s patients on methotrexate, but it is reasonable to infer that it may have played a role in our patient’s presentation. Bone trauma seems to be associated with the development of Brodie’s abscess, and our patient reported a long history of chronic left hip and thigh pain due to a remote sports-related injury to that region. The source of his infection was most likely transient bacteremia, which seeded this nidus in his anterior superior iliac spine. While causation cannot be determined, this interesting case serves as reminder to prescribers of dual immunosuppressive therapy to be cognizant of infectious complications outside of those commonly attributed.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S499-S501
Author(s):  
W Badre ◽  
O Bahlaoui ◽  
F Z El Rhaoussi ◽  
M Tahiri ◽  
F Haddad ◽  
...  

Abstract Background The occurrence of intestinal stenosis is a common and potentially serious complication of Crohn’s disease (CD). These strictures represent 20% of the surgical indications in CD. Endoscopic dilation is an alternative to surgery for endoscopically accessible stenosis. The aim of this study is to evaluate the effectiveness of endoscopic balloon dilation (EBD) in CD intestinal stenosis. Methods This retrospective, descriptive study realized between January 2015 and October 2020, included CD patients diagnosed at least 6 months before and complicated with symptomatic intestinal stenosis (abdominal pain, bloating, nausea and vomiting). Anorectal strictures were excluded. All patients had a cross-sectional imaging before intestinal dilation to determine the characteristics of the stenosis and exclude abscess and fistula tract near the stenosis which constitute a contraindication of EBD. All patients underwent an EBD during a colonoscopy under sedation by propofol. The short-term success of EBD has been established on both technical (passage of the endoscope across the site of stenosis after dilation) and clinical level (relief of intestinal obstructive symptoms). The long-term efficacy was defined by no need for surgery within 6 months after dilation. Results Twelve patients (6 males and 6 females), with an average age of 32 years +/-7.7, were included. The average interval between onset of CD and the onset of intestinal stricture was 8 years. Eight patients had a history of bowel resection. The stenosis was located at the terminal ileum or ileocaecal valve in 4 cases, ileocolic anastomosis in 8 cases. The stenosis was ulcerated in 9 cases, inflammatory in 5 cases and polypoid in 3 cases. All patients were on medical treatment corticosteroids, Azathioprine and / or Anti TNF. We performed 18 EBD, divided into several sessions depending on the degree of stenosis (1 EBD, 2 EBD and 3 EBD in respectively 11, 3 and 2 patients). Two patients required surgery for persisting symptoms. Technical success was obtained in 11 patients (92% of cases). Clinical success, defined by a disappearance of clinical symptoms with an HBI score of less than 4, was obtained in 9 patients (75% of cases). The mean follow-up after dilation was 23 months (range from 8 to 42 months). No major complications were observed in this study. Conclusion EBD is an effective therapeutic technique relatively safe for intestinal CD stenosis, allowing to delay or better, to avoid surgical treatment when the stenosis is well selected (stenosis<4cm, single, anastomotic, non-angled, and without adjacent abscess or fistula).


2020 ◽  
Vol 158 (3) ◽  
pp. S101-S102
Author(s):  
Julia Schuchard ◽  
Michael Kappelman ◽  
Andrew Grossman ◽  
Jennifer Clegg ◽  
Christopher Forrest

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S72-S72
Author(s):  
Ahmed Elmoursi ◽  
Courtney Perry ◽  
Terrence Barrett

Abstract Background Stricturing Crohn’s disease (CD) constitutes a severe phenotype often associated with a high degree of morbidity (3). Surgical resection is first-line therapy for symptomatic strictures, but most patients relapse without subsequent medical therapy (4–5). Biologics are the mainstay for inducing and maintaining remission, but some cases are refractory despite maximum dosage of therapy. Reports of dual biological therapy (DBT) in refractory, stricturing CD are sparse, and prior case reports document only clinical remission (1). To contribute further knowledge regarding the use of DBT in stricturing CD, we present the case of a refractory CD patient who achieved deep remission with ustekinumab and vedolizumab. Case Presentation A 35 year old non-smoking, Caucasian male was referred to our clinic in 2014 for refractory CD complicated by multiple strictures. Prior to establishing care with us, he received two jejunal resections and a sigmoid resection. Previously failed therapies included azathioprine with infliximab, adalimumab, and certolizumab. He continued to progress under our care despite combination methotrexate/certolizumab, as well as methotrexate/golimumab. He underwent proctocolectomy with end ileostomy in 2015 and initiated vedolizumab q8weeks post-operatively. He reoccurred in 2018, when he presented with an ulcerated ileal stricture. He was switched from vedolizumab to ustekinumab q8weeks and placed on prednisone, but continued to progress, developing significant hematochezia requiring hospitalization and blood transfusions. Ileoscopy performed during hospital admission confirmed severe, ulcerating disease in the ileum with stricture. Ustekinumab dosing was increased to q4weeks, azathioprine was initiated, and he underwent stricturoplasty. Follow-up ileoscopy three months later revealed two ulcers in the neo- TI (Figure 1). Vedolizumab q8weeks was initiated in addition to ustekinumab q4weeks and azathioprine 125mg. After four months on this regimen the patient felt better, but follow-up ileoscopy showed two persistent ulcers in the neo-TI. Vedolizumab dosing interval was increased to q4weeks. After four months, subsequent ileoscopy demonstrated normal neo-TI (Figure 2). Histologic evaluation of biopsies confirmed deep remission of crohn’s disease. No adverse side effects have occurred with maximum doses of both ustekinumab and vedolizumab combination therapy. Discussion This case supports both the safety and efficacy of ustekinumab and vedolizumab dual biologic therapy for treatment of severe, refractory Crohn’s disease. While there are reports of DBT inducing clinical remission, this case supports efficacy for vedolizumab and ustekinumab combination therapy to induce deep histologic remission. Large practical clinical trials are needed to better investigate the safety and efficacy of DBT with vedolizumab and ustekinumab, but our case suggests this combination may be a safe and efficacious therapy for refractory CD patients.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Shin Emoto ◽  
Shigenori Homma ◽  
Tadashi Yoshida ◽  
Nobuki Ichikawa ◽  
Yoichi Miyaoka ◽  
...  

Abstract Background The improved prognosis of Crohn’s disease may increase the opportunities of surgical treatment for patients with Crohn’s disease and the risk of development of colorectal cancer. We herein describe a patient with Crohn’s disease and a history of multiple surgeries who developed rectal stump carcinoma that was treated laparoscopically and transperineally. Case presentation A 51-year-old man had been diagnosed with Crohn’s disease 35 years earlier and had undergone several operations for treatment of Crohn’s colitis. Colonoscopic examination was performed and revealed rectal cancer at the residual rectum. The patient was then referred to our department. The tumor was diagnosed as clinical T2N0M0, Stage I. We treated the tumor by combination of laparoscopic surgery and concomitant transperineal resection of the rectum. While the intra-abdominal adhesion was dissected laparoscopically, rectal dissection in the correct plane progressed by the transperineal approach. The rectal cancer was resected without involvement of the resection margin. The duration of the operation was 3 h 48 min, the blood loss volume was 50 mL, and no intraoperative complications occurred. The pathological diagnosis of the tumor was type 5 well- and moderately differentiated adenocarcinoma, pT2N0, Stage I. No recurrence was evident 3 months after the operation, and no adjuvant chemotherapy was performed. Conclusion The transperineal approach might be useful in patients with Crohn’s disease who develop rectal cancer after multiple abdominal surgeries.


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