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Background: Patient activation refers to patients' independence in daily activities, involvement in the therapeutic process, and ability to manage their health. This study examined the association between the activation of patients with inflammatory bowel disease (IBD) and its effect on health indices. Objectives: To evaluate the association between the activation of patients with IBD measured by patient activation measure (PAM-13) questionnaire with disease activity and quality of life in IBD. Design: A retrospective cross-sectional study. Methods: This study included patients with Crohn's Disease (CD) or ulcerative colitis (UC) followed at a large medical center in Israel, who were recruited during routine visits. They answered weekly questionnaires using a mobile smartphone application that included clinical and emotional disease parameters, including IBD control, quality of life [short IBD quality of life questionnaire (SIBDQ)], patient-reported outcomes measurement information system (PROMIS-10) and PAM-13. Additional clinical parameters were collected from electronic medical records. Results: Among 201 patients (113 females) who responded to the questionnaires, 152 (75.6%) had CD and 49 (24.4%) UC. For PAM-13, 158 (79%) patients were at PAM-13 levels 3–4 (mean score: 68.5, range: 60.0–73.1) and 43 (21%) were at levels 1–2 (mean score: 45.2, range: 40.9–49.9). PAM-13 levels were correlated with IBD control (r = 0.19, p = 0.023), SIBDQ (r = 0.20, p = 0.010), and PROMIS-10 score (r = 0.24, p = 0.017). Conclusions: Our findings demonstrate the importance of patient activation and engagement in IBD. Knowledge of patient activation may enable caregivers to predict levels of self-care and the likelihood of compliance with health behavior recommendations. [ABSTRACT FROM AUTHOR]

Background: The diagnosis of proximal small bowel involvement in Crohn's disease (CD) can be challenging at magnetic resonance enterography (MRE). The inflammatory process in CD can be associated with peri-intestinal inflammatory reactions, including the presence of inflamed mesenteric lymph nodes. Objectives: To evaluate the significance of inflamed mesenteric lymph nodes adjacent to the jejunum at MRE in CD and the association with proximal bowel disease as detected by video capsule endoscopy (VCE). Design: This retrospective study was performed in two tertiary medical centres, and included 64 patients with CD who underwent MRE as well as VCE within 1 year. Methods: Data were collected for examinations performed between August 2013 and February 2021. MRE images were independently reviewed by radiologists who were blinded to the clinical data. Association between the presence of mesenteric lymph nodes adjacent to jejunum at MRE and disease activity according to VCE Lewis scores of proximal small bowel was examined. Results: VCE detected proximal disease in 24/64 patients (37.5%). Presence of regional lymph nodes in the jejunal mesentery was significantly associated with jejunal disease as seen on VCE (p < 0.001). Of the 20 patients who had proximal mesenteric lymph nodes at MRE, 15 (75%) had jejunal disease at VCE (sensitivity, 62.5%; specificity, 87.5%; and negative and positive predictive values, 79.5 and 75%, respectively). The number of regional lymph nodes was positively correlated with jejunal disease (mean: 2.63 ± 2.90 versus 0.78 ± 2.60, p = 0.01). Other MRE features of lymph nodes were not significantly predictive of jejunal CD. Conclusion: In patients with CD, inflamed regional lymph nodes in the jejunal mesentery at MRE can be valuable to suggest proximal small bowel disease, even when bowel wall features at imaging do not suggest disease involvement. Plain language summary: The diagnosis of proximal small bowel involvement in Crohn's disease (CD) can be challenging at magnetic resonance enterography (MRE). We analysed MRE examinations in patients with CD for the presence of lymph nodes adjacent to the proximal small bowel. We included 64 patients with CD who had MRE examinations and video capsule endoscopy (VCE) examinations within 1 year. Of 64 patients, 24 had proximal small bowel disease according to VCE. We found that of 20 patients who had regional mesenteric lymph nodes in the jejunal mesentery at MRE, 15 had proximal bowel disease involvement. We also found that patients with jejunal disease had a larger number of regional lymph nodes compared to patients without jejunal disease. All but one patient had normal appearing bowel at MRE. But, using regional mesenteric lymphadenopathy at MRE as an indicator for disease, 15/24 (62.5%) patients with proximal small bowel disease were detected. We therefore conclude that regional mesenteric lymph nodes assessment at MRE can aid diagnose proximal bowel disease, even when the proximal bowel looks normal at imaging. Presence of proximal mesenteric lymph nodes at MRE in patients with CD possibly warrant further investigation of the proximal small bowel by endoscopic measures. [ABSTRACT FROM AUTHOR]

Background: Evidence regarding the risk of immunogenicity in patients with inflammatory bowel disease (IBD) who switched anti-tumor necrosis factor alpha (anti-TNFα) therapies to a subsequent anti-TNFα (either infliximab or adalimumab) is conflicting. We aimed to assess the risk of consecutive immunogenicity to anti-TNFα in a large cohort of patients. Methods: This was a multicenter retrospective study. Medical records of adult and pediatric IBD switchers who had pharmacokinetic data for both agents between 2014 and 2020 were retrieved. Data including age, sex, disease type, duration of therapies, and concomitant use of immunomodulators (IMMs) were recorded. Results: Overall, 164 patients were included [52% female; 88% Crohn's disease; mean age = 24.4 ± 14.6 years; 108 (66%) switched from infliximab to adalimumab and 56 (34%) vice versa]; 120 (73.1%) patients switched due to an immunogenic failure. Among patients switching therapy from infliximab to adalimumab due to an immunogenic failure immunogenicity to infliximab was significantly associated with consecutive immunogenicity to adalimumab (p = 0.026). Forthy four out of 120 patients (36.6%) with an immunogenic failure to the first anti-TNFα started an IMM with the second anti-TNFα. This combination with IMM was not associated with reduction of consecutive immunogenicity (p = 0.31), but it was associated with longer drug retention (p = 0.007). Multivariate analysis demonstrated that older age at second anti-TNFα, adjusted to the chronology of therapy and sex, was associated with increased immunogenicity to the second anti-TNFα. Conclusion: Patients with IBD who switch from infliximab to adalimumab following an immunogenic failure are at increased risk for consecutive immunogenicity to adalimumab. IMM use after a switch prolongs drug retention. [ABSTRACT FROM AUTHOR]

Background: Video capsule endoscopy (VCE) has been proven to accurately diagnose small-bowel inflammation and predict flares among patients with quiescent Crohn's disease (CD). However, data regarding its predictive role in this population over an extended follow-up are scarce. Objectives: To predict clinical exacerbation and to assess the yield of Lewis score in identifying CD patients with future clinical exacerbation during an extended follow-up (>24 months). Design: A post hoc analysis study. Methods: Adult patients with quiescent small-bowel CD who were followed with VCE, inflammatory biomarkers and magnetic resonance enterography in a prospective study (between 2013 and 2018). We extracted extended clinical data (up to April 2022). The primary composite outcome (i.e. clinical exacerbation) was defined as intestinal surgery, endoscopic dilation, CD-related admission, corticosteroid administration, or biological/immunomodulator treatment change during follow-up. Results: Of the 61 patients in the study [median age 29 (24–37) years, male 57.4%, biologic treatment 46.7%], 18 patients met the primary outcome during an extended follow-up [median 58.0 (34.5–93.0) months]. On univariable analysis, complicated [hazard ratio (HR) 7.348, p = 0.002] and stricturing disease phenotype (HR 5.305, p = 0.001) were associated with higher risk for clinical exacerbation during follow-up. A baseline VCE middle small-bowel segment Lewis score (midLS) ⩾ 135 identified patients with future exacerbation [AUC (area under the curve) 0.767, 95% confidence interval (CI) 0.633–0.902, p = 0.001, HR 6.317, 93% negative predictive value], whereas the AUC of the conventional Lewis score was 0.734 (95% CI: 0.589–0.879, p = 0.004). Sensitivity analysis restricted to patients with either complicated (n = 34) or stricturing (n = 26) disease phenotype revealed that midLS still predicted clinical exacerbation during follow-up (AUC 0.747/0.753, respectively), in these patients. Conclusion: MidLS predicts treatment failure in quiescent CD patients (median follow-up of 5 years) independently of disease phenotype. [ABSTRACT FROM AUTHOR]

Background: Deep learning techniques can accurately detect and grade inflammatory findings on images from capsule endoscopy (CE) in Crohn's disease (CD). However, the predictive utility of deep learning of CE in CD for disease outcomes has not been examined. Objectives: We aimed to develop a deep learning model that can predict the need for biological therapy based on complete CE videos of newly-diagnosed CD patients. Design: This was a retrospective cohort study. The study cohort included treatment-naïve CD patients that have performed CE (SB3, Medtronic) within 6 months of diagnosis. Complete small bowel videos were extracted using the RAPID Reader software. Methods: CE videos were scored using the Lewis score (LS). Clinical, endoscopic, and laboratory data were extracted from electronic medical records. Machine learning analysis was performed using the TimeSformer computer vision algorithm developed to capture spatiotemporal characteristics for video analysis. Results: The patient cohort included 101 patients. The median duration of follow-up was 902 (354–1626) days. Biological therapy was initiated by 37 (36.6%) out of 101 patients. TimeSformer algorithm achieved training and testing accuracy of 82% and 81%, respectively, with an Area under the ROC Curve (AUC) of 0.86 to predict the need for biological therapy. In comparison, the AUC for LS was 0.70 and for fecal calprotectin 0.74. Conclusion: Spatiotemporal analysis of complete CE videos of newly-diagnosed CD patients achieved accurate prediction of the need for biological therapy. The accuracy was superior to that of the human reader index or fecal calprotectin. Following future validation studies, this approach will allow for fast and accurate personalization of treatment decisions in CD. [ABSTRACT FROM AUTHOR]

Background: Video capsule endoscopy (VCE) has been proven to accurately diagnose small-bowel inflammation and predict flares among patients with quiescent Crohn’s disease (CD). However, data regarding its predictive role in this population over an extended follow-up are scarce. Objectives: To predict clinical exacerbation and to assess the yield of Lewis score in identifying CD patients with future clinical exacerbation during an extended follow-up (>24 months). Design: A post hoc analysis study. Methods: Adult patients with quiescent small-bowel CD who were followed with VCE, inflammatory biomarkers and magnetic resonance enterography in a prospective study (between 2013 and 2018). We extracted extended clinical data (up to April 2022). The primary composite outcome (i.e. clinical exacerbation) was defined as intestinal surgery, endoscopic dilation, CD-related admission, corticosteroid administration, or biological/immunomodulator treatment change during follow-up. Results: Of the 61 patients in the study [median age 29 (24-37) years, male 57.4%, biologic treatment 46.7%], 18 patients met the primary outcome during an extended follow-up [median 58.0 (34.5-93.0) months]. On univariable analysis, complicated [hazard ratio (HR) 7.348, 푝 = 0.002] and stricturing disease phenotype (HR 5.305, 푝 = 0.001) were associated with higher risk for clinical exacerbation during follow-up. A baseline VCE middle small-bowel segment Lewis score (midLS) ⩾ 135 identified patients with future exacerbation [AUC (area under the curve) 0.767, 95% confidence interval (CI) 0.633-0.902, 푝 = 0.001, HR 6.317, 93% negative predictive value], whereas the AUC of the conventional Lewis score was 0.734 (95% CI: 0.589- 0.879, 푝 = 0.004). Sensitivity analysis restricted to patients with either complicated (푛 = 34) or stricturing (푛 = 26) disease phenotype revealed that midLS still predicted clinical exacerbation during follow-up (AUC 0.747/0.753, respectively), in these patients. Conclusion: MidLS predicts treatment failure in quiescent CD patients (median follow-up of 5 years) independently of disease phenotype. [ABSTRACT FROM AUTHOR]

Background: Deep learning techniques can accurately detect and grade inflammatory findings on images from capsule endoscopy (CE) in Crohn’s disease (CD). However, the predictive utility of deep learning of CE in CD for disease outcomes has not been examined. Objectives: We aimed to develop a deep learning model that can predict the need for biological therapy based on complete CE videos of newly-diagnosed CD patients. Design: This was a retrospective cohort study. The study cohort included treatment-naïve CD patients that have performed CE (SB3, Medtronic) within 6 months of diagnosis. Complete small bowel videos were extracted using the RAPID Reader software. Methods: CE videos were scored using the Lewis score (LS). Clinical, endoscopic, and laboratory data were extracted from electronic medical records. Machine learning analysis was performed using the TimeSformer computer vision algorithm developed to capture spatiotemporal characteristics for video analysis. Results: The patient cohort included 101 patients. The median duration of follow-up was 902 (354–1626) days. Biological therapy was initiated by 37 (36.6%) out of 101 patients. TimeSformer algorithm achieved training and testing accuracy of 82% and 81%, respectively, with an Area under the ROC Curve (AUC) of 0.86 to predict the need for biological therapy. In comparison, the AUC for LS was 0.70 and for fecal calprotectin 0.74. Conclusion: Spatiotemporal analysis of complete CE videos of newly-diagnosed CD patients achieved accurate prediction of the need for biological therapy. The accuracy was superior to that of the human reader index or fecal calprotectin. Following future validation studies, this approach will allow for fast and accurate personalization of treatment decisions in CD. [ABSTRACT FROM AUTHOR]

Background: Screening with colonoscopy for all average-risk population is probably not cost-effective due to the limited sources and over-generalization of the risk, and risk stratification can be used to optimize colorectal cancer screening. Objectives: We aimed to assess risk factors for advanced neoplasia (AN) and a classification tree algorithm to predict the risk. Design: This is a retrospective cross-sectional study. Methods: This study was composed of consecutive asymptomatic average-risk individuals undergoing first screening colonoscopy between 2008 and 2019. Detailed characteristics including background diseases, habits, and medications were collected. We used multivariable logistic regression to investigate the associations between clinical variables and the presence of AN and built a classification algorithm to predict AN. Results: A total of 3856 patients were included (73.2% male, median age 55). Adenoma and AN detection rate were 15.8% and 3.4%, respectively. On multivariable analysis, predictors of AN [odds ratio (OR), 95% confidence interval (CI)] were age (1.04, 1.01–1.06, p = 0.003), male sex (2.69, 1.56–4.64, p < 0.001), and smoking (1.97, 1.38–2.81, p < 0.001). A classification tree algorithm showed that smoking was the most important risk factor for prediction of AN (4.9% versus 2.4%, p < 0.001), followed by age with a cutoff value of 60 in the smokers (8.4% versus 3.8%, p = 0.001) and 50 in the non-smokers (2.9% versus 0.9%, p = 0.004). Conclusion: Smoking habits, old age, and male gender are highly associated with an increased risk for AN and should be incorporated in the individualized risk-assessment to adapt a screening program. [ABSTRACT FROM AUTHOR]

Background: Higher infliximab trough levels (TLs) correlate with better clinical, inflammatory, and endoscopic outcomes among inflammatory bowel disease (IBD) patients. Although standard scheduled infliximab therapy regimen consists of infusions at pre-defined time-points (weeks 0, 2, 6, and every 8 weeks), short-period deviations from therapeutic schedule are common in 'real life', but the pharmacokinetic impact of these deviations has not been explored. In this study, we aim to determine whether short-period deviations from infusion schedule affect infliximab-TL. Methods: A retrospective analysis of all IBD patients receiving infliximab maintenance therapy every 8 weeks was conducted in a tertiary medical center. Patients with anti-drug antibodies, deliberate interval shortening and <3 sequential maintenance sera available were excluded. Associations between time since last infusion and TL were studied. Statistical analysis was performed using generalized estimating equations. Results: Out of over 10,000 sera, 2088 sera of 302 maintenance period stable infliximab-therapy-patients met inclusion criteria (median TL 4.1 μg/mL, interquartile range (IQR) 2.3–6.5 μg/mL). A delay beyond 3 days in infusion schedule (n > 59 days since last infusion) was found to significantly affect TL (mean difference in TL 0.9 μg/mL, 95% confidence interval (CI): 0.03–1.9 μg/mL, p < 0.04). Furthermore, among patients with delayed infusions, 80% had TL below 5 μg/mL, in comparison to 55% of patients who were not late (odds ratio (OR): 2.81, CI: 2.02–3.92, p < 0.0001). Conclusion: Real-life delays of ⩽3 days from infusion protocol can probably be allowed. Delays >3 days culminate in measurable decrease of TL, although effect on clinical outcome is unclear. This needs to be taken into account when interpreting drug-level test results. Summary: A total of 2088 sera of 302 maintenance period inflammatory bowel disease (IBD) patients treated with infliximab were analyzed, to assess effect of small deviations from infusion schedule on TLs. A significant decline in patients' trough level (TL) was noted as early as 3 days after scheduled infusion. [ABSTRACT FROM AUTHOR]

Background: Depression and anxiety are common among inflammatory bowel disease (IBD) patients. Not only do they worsen quality of life, but also worsen the prognosis of the IBD. Yet, there are no widely accepted guidelines for screening for depression or anxiety in this population. The Hospital Anxiety and Depression Scale (HADS) is a self-administered questionnaire designed to measure anxiety and depression in the physically ill. The purpose of this study was to establish the utility of the HADS as a screening tool in IBD patients. Methods: Seventy-nine IBD patients (age 29.86 ± 8.36, 51.9% female, 77.2% Crohn's disease) were recruited consecutively at the day treatment unit, Gastroenterology Department, Sheba Medical Center. They were asked to complete the HADS, the Beck Depression Inventory (BDI), and the State-Trait Anxiety Inventory (STAI). The scores of the HADS depression and anxiety subscales were correlated with the BDI and STAI scores, and the rates of above-threshold scores were calculated and compared between the three questionnaires and findings from previous studies. Results: The two HADS subscales significantly correlated with and the BDI (rs =.69, p < 0.001) and STAI state and trait anxiety (rs =.853, p < 0.001; r s =.744, p < 0.001, respectively). The usual HADS cut-off scores yielded adequate rate of anxiety but lower than expected depression rates. Conclusions: Our findings suggest the HADS as a valid screening tool for anxiety and depression in IBD patients. We recommend administering it routinely in gastrointestinal (GI) follow-ups using a lower cut-off score for depression than anxiety (greater than 7 vs greater than 11, respectively). [ABSTRACT FROM AUTHOR]

Background: Intra-abdominal abscess (IA) is an important clinical complication of Crohn's disease (CD). A high index of clinical suspicion is needed as imaging is not routinely used during hospital admission. This study aimed to identify clinical predictors of an IA among hospitalized patients with CD using machine learning. Methods: We created an electronic data repository of all patients with CD who visited the emergency department of our tertiary medical center between 2012 and 2018. We searched for the presence of an IA on abdominal imaging within 7 days from visit. Machine learning models were trained to predict the presence of an IA. A logistic regression model was compared with a random forest model. Results: Overall, 309 patients with CD were hospitalized and underwent abdominal imaging within 7 days. Forty patients (12.9%) were diagnosed with an IA. On multivariate analysis, high C-reactive protein (CRP) [above 65 mg/l, adjusted odds ratio (aOR): 16 (95% CI: 5.51–46.18)], leukocytosis [above 10.5 K/μl, aOR: 4.47 (95% CI: 1.91–10.45)], thrombocytosis [above 322.5 K/μl, aOR: 4.1 (95% CI: 2–8.73)], and tachycardia [over 97 beats per minute, aOR: 2.7 (95% CI: 1.37–5.3)] were independently associated with an IA. Random forest model showed an area under the curve of 0.817 ± 0.065 with six features (CRP, hemoglobin, WBC, age, current biologic therapy, and BUN). Conclusion: In our large tertiary center cohort, the machine learning model identified the association of six clinical features (CRP, hemoglobin, WBC, age, BUN, and biologic therapy) with the presentation of an IA. These may assist as a decision support tool in triaging CD patients for imaging to exclude this potentially life-threatening complication. [ABSTRACT FROM AUTHOR]