Web-based dietary assessment and advice helps inflammatory bowel disease patients to improve their diet quality.

Time to evaluate diet quality and give dietary advice is limited in clinical IBD practice. The Eetscore is a web-based tool that assesses diet quality according to the Dutch dietary guidelines and provides personalised dietary advice. We aimed to assess diet quality of IBD patients using the Eetscore and to study changes in diet quality, health-related quality of life (HRQoL) and clinical disease activity over time. A prospective cohort study was performed in 195 adult IBD patients. Participants were invited to fill out questionnaires (Eetscore-FFQ, short IBDQ and p-HBI/p-SCCAI) at baseline and after 1 and 4 months. The Eetscore calculates diet quality based on 16 food components (10 points per component, total score 0-160; the higher the better) and provides dietary advice per component based on the assessment. At baseline, mean diet quality was 98±19. Diet quality was positively associated with age, female gender and level of education. Component scores were highest for red meat, wholegrain products, and sweetened beverages, and lowest for legumes, nuts, and processed meat. Over time, diet quality increased to 107±21 at 4 months (p<0.001). Each 10-point improvement in diet quality was associated with an increase in HRQoL (ß=0.4 (95%CI 0.02; 0.7), p=0.04). Clinical disease activity did not change. In conclusion, diet quality of IBD patients significantly improved following personalised dietary advice of the Eetscore. Improvement of diet quality was associated with a slight improvement in HRQoL. The Eetscore is a practical and useful tool to monitor and support a healthy diet in IBD patients.

Mobile application to monitor inflammatory bowel disease patients on intravenous biologic treatment: a feasibility study.

BACKGROUND: Monitoring of IBD patients on intravenous biologic treatment is recommended but time-consuming for patients and nurses. We developed a mobile application (app) to promote self-management and studied its feasibility in clinical practice. METHODS: Adult IBD patients treated with intravenous infliximab or vedolizumab used the app over four biologic treatments. The app includes information modules and an interactive timeline with notifications of blood tests and health checks before treatment. RESULTS: In total, 55 patients participated of whom 71% had Crohn's disease and 85% used infliximab. Compliance with health checks and blood tests was 67% before the first biologic treatment and 70, 87, and 80% before the second, third, and fourth treatment, respectively. The median number of times the app was used per treatment varied from 6 to 8 times (≥4 considered sufficient). Patients were satisfied with the app [median VAS score 8 (IQR 7-9)] and remained equally satisfied with IBD care [score 8 (IQR 8-9) before and after app use]. Nurses contacted all patients by telephone before the first biologic treatment, as previous standard care. Before the second, third, and fourth treatment only 47, 35, and 49% of patients were contacted. The majority (92%) wanted to continue using the app after the study. CONCLUSIONS: Monitoring of IBD patients treated with intravenous biologics using an app is feasible. We saw high compliance, sufficient app use, and high patient satisfaction. Moreover, health-care utilization was reduced and almost all patients preferred using the app over previous standard care (ClinicalTrials.gov NCT04254614).

Distribution of mucosal PD-1 expressing T cells in patients with colitis of different etiologies.

BACKGROUND: Immunotherapy, targeting programmed death-1 (PD-1) enhances antitumor T-cell activity in patients with malignancies. Blocking PD-1 or its ligand may lead to fulminant colitis as serious adverse event in these patients. Since little is known of the presence and role of PD-1+T cells in colitis of different etiologies, we determined PD-1+T cells in mucosal specimens of patients with inflammatory bowel disease, infectious colitis (InfC), immunotherapy-related colitis (ImC) and healthy controls (HC). METHODS: Newly diagnosed patients with ulcerative colitis (UC, n = 73), Crohn's disease (CD, n = 50), InfC (n = 5), ImC (n = 8) and HC (n = 8) were included. Baseline inflamed colonic biopsies were studied with immunohistochemistry and flowcytometry. RESULTS: Using immunohistochemistry, PD-1 was not present on lymphocytes in the epithelium of all patients, nor in HC. The percentage PD-1+ of all lymphocytes in the lamina propria was 40% in UC, 5% in InfC, 3% in ImC and 0% in HC. Flowcytometry showed significant higher percentages of PD-1+T cells in inflamed biopsy specimens of UC patients (22%) compared to all other groups: CD patients (13%), InfC (12%), ImC (5%) and HC (6%). CONCLUSION: There are relevant differences in distribution and frequencies of mucosal PD-1+ T-cell subsets in patients with UC, CD, InfC and ImC, supporting the hypothesis that these types of colitis are driven by different immunological pathways. The increased numbers of PD-1+ and PD-L1+ lymphocytes in the colonic mucosa of UC patients suggest that the PD-1/PD-L1 pathway might be more activated in UC than in CD.

Improvement of Fatigue and Quality of Life in Patients with Quiescent Inflammatory Bowel Disease Following a Personalized Exercise Program.

BACKGROUND AND AIMS: Fatigue significantly impacts the quality of life of patients with inflammatory bowel disease (IBD). This study aimed to assess the effect of a personalized, intensive exercise program on fatigue, health-related quality of life (HRQoL), and cardiorespiratory fitness in patients with quiescent IBD and severe fatigue. METHODS: A pilot study was performed including IBD patients in remission with severe fatigue. The 12-week exercise program consisted of three times per week 1-h sessions, including aerobic- and progressive-resistance training at personalized intensity based on a cardiopulmonary exercise test (CPET) and one-repetition maximum. CPET was repeated after 12 weeks. Fatigue and HRQoL were assessed using the checklist individual strength and 32-item IBD questionnaire. RESULTS: Twenty-five IBD patients with mean age of 45 (± 2.6) years were included of which 22 (88%) completed the exercise program. Fatigue significantly improved from 105 (± 17) points on the checklist individual strength before, to 66 (± 20) after completion of exercise program (p < 0.001). Patients' HRQoL significantly improved from 156 (± 21) to 176 (± 19) (p < 0.001). When looking at the subdomains of HRQoL, significant improvement was seen in emotional (58 ± 12 vs. 69 ± 9.1, p = 0.003), systemic (19 ± 3.9 vs. 24 ± 4.7, p < 0.001), and social function (25 ± 5.4 vs. 30 ± 3.9, p < 0.001). Bowel symptoms did not change (53 ± 7.7 vs. 55 ± 7.3, p = 0.208). Repeat CPET showed a significant improvement in maximum power patients were able to deliver (2.4 ± 0.5 vs. 2.7 ± 0.5 W/kg, p = 0.002). CONCLUSIONS: A personalized, intensive exercise program can lead to significant improvement of fatigue, HRQoL, and cardiorespiratory fitness in patients with quiescent IBD and severe fatigue.

Risk factors and clinical outcomes of endoscopic dilation in benign esophageal strictures: a long-term follow-up study.

BACKGROUND AND AIMS: Endoscopic dilation (ED) is still the mainstay of therapeutic management of benign esophageal strictures (BESs). This study aimed to establish risk factors for refractory BESs and assess long-term clinical outcomes of ED. METHODS: We performed a retrospective study in 891 patients who underwent ED from 2003 to 2018 for BESs. We searched electronic medical records in 6 tertiary care centers in the Netherlands for data on clinical outcome of ED. Median follow-up was 39 months. The primary endpoint was risk factors for refractory BESs, defined as factors associated with an increased number of ED sessions during follow-up. Secondary endpoints were time from first to last ED session and adverse events. RESULTS: Dilation up to 13 to 15 mm was associated with a higher number of ED sessions than dilation up to 16 to 18 mm (5.0 vs 4.1; hazard ratio [HR], 1.4; P = .001). Compared with peptic strictures, anastomotic (4.9 vs 3.6; HR, 2.1; P < .001), radiation (5.0 vs 3.6; HR, 3.0; P < .001), caustic (7.2 vs 3.6; HR, 2.7; P < .001), and postendotherapy (3.9 vs 3.6; HR, 1.8; P = .005) strictures were associated with a higher number of ED sessions. After 1 year of follow-up, the proportions of patients who remained free of ED was 75% in anastomotic, 71% in radiation, 70% in peptic, 83% in postendotherapy, and 62% in caustic strictures. Esophageal perforation occurred in 23 ED sessions (.4%) in 22 patients (2.4%). CONCLUSIONS: More than 60% of patients with BESs remain free of ED after 1 year of follow-up. Because dilation up to 16 to 18 mm diameter was associated with fewer ED sessions during follow-up, we suggest that clinicians should consider dilation up to at least 16 mm to reduce the number of ED sessions in these patients.

Impact of multidisciplinary tumor board discussion on palliation of patients with esophageal or gastro-esophageal junction cancer: a population-based study.

Background: The Dutch guidelines for esophageal and gastro-esophageal junction (GEJ) cancer recommend discussion of patients by a multidisciplinary tumor board (MDT). Despite this recommendation, one previous study in the Netherlands suggested that therapeutic guidance was missing for palliative care of patients with esophageal cancer. The aim of the current study was therefore to assess the impact of an MDT discussion on initial palliative treatment and outcome of patients with esophageal or GEJ cancer.Material and methods: The population-based Netherlands Cancer Registry was used to identify patients treated for esophageal or GEJ cancer with palliative intent between 2010 and 2017 in 7 hospitals. We compared patients discussed by the MDT with patients not discussed by the MDT in a multivariate analysis. Primary outcome was type of initial palliative treatment. Secondary outcome was overall survival.Results: A total of 389/948 (41%) patients with esophageal or GEJ cancer were discussed by the MDT before initial palliative treatment. MDT discussion compared to non-MDT discussion was associated with more patients treated with palliative intent external beam radiotherapy (38% vs. 21%, OR 2.7 [95% CI 1.8-3.9]) and systemic therapy (30% vs. 23%, OR 1.6 [95% CI 1.0-2.5]), and fewer patients treated with stent placement (4% vs. 12%, OR 0.3 [95% CI 0.1-0.6]) and best supportive care alone (12% vs. 33%, OR 0.2 [95% CI 0.1-0.3]). MDT discussion was also associated with improved survival (169 days vs. 107 days, HR 1.3 [95% CI 1.1-1.6]).Conclusion: Our study shows that MDT discussion of patients with esophageal or GEJ cancer resulted in more patients treated with initial palliative radiotherapy and chemotherapy compared with patients not discussed by the MDT. Moreover, MDT discussion may have a positive effect on survival, highlighting the importance of MDT meetings at all stages of treatment.

A novel fully covered double-bump stent for staple line leaks after bariatric surgery: a retrospective analysis.

BACKGROUND: Staple line leakage after bariatric surgery can be treated by endoscopic placement of a self-expandable stent. The success rate of stent placement is generally high, but migration is a frequent adverse event that hampers successful treatment. The Niti-S Beta stent is a fully covered double-bump stent that was specifically designed to prevent migration. This study aimed to evaluate the effectiveness and adverse event rate of the Niti-S Beta stent. METHODS: A retrospective study was performed in three high-volume bariatric centers. All consecutive patients between 2009 and 2016 who underwent placement of a Beta stent for staple line leakage were included. Primary outcome was resolution of the leakage; secondary outcome was the adverse event rate including migration. RESULTS: Thirty-eight patients were included. Twenty-five (66%) had resolution of the leakage. Success rate was higher in patients who were treated with implantation of a Beta stent as initial treatment (100%) than in patients who were treated with a stent after revisional surgery had failed (55%, p = 0.013). Migration occurred in 12 patients (32%). There were two severe adverse events requiring surgical intervention, including a bleeding from an aorto-esophageal fistula. CONCLUSIONS: The success rate and the migration rate of the Beta stent seem comparable to other stents in this retrospective study. Despite the novel double-bump structure of the stent, the migration rate does not seem to be decreased.

Changes in glycemic control and body weight after explantation of the duodenal-jejunal bypass liner.

BACKGROUND AND AIMS: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device that induces weight loss and improves glycemic control in patients with type 2 diabetes mellitus (T2DM). The aim of the current study was to assess the effects of DJBL explantation on glycemic control and body weight. METHODS: This prospective, observational study included only patients with T2DM who had the DJBL implanted for at least 6 months and had a follow-up of at least 12 months after explantation. The primary endpoints were changes in glycosylated hemoglobin A1c (HbA1c) and body weight during the 12 months after explantation. Secondary endpoints were changes in fasting plasma glucose, blood pressure, and plasma lipid levels. RESULTS: In total, 59 patients completed the 12-month follow-up after explantation. During this period body weight increased by 5.6 (standard deviation, 6.4) kg (P < .001) and HbA1c rose from 65 (SD 17) to 70 (SD 20) mmol/mol (P < .001). However, body weight remained 8.0 (SD 8.6) kg (P < .001) lower than before implantation, that is, corresponding to a net total body weight loss of 7.4% (SD 7.6) (P < .001). Although HbA1c was significantly higher 12 months after explantation compared with baseline and the mean daily dose of insulin used was comparable, the number of patients on insulin remained significantly lower than before implantation. CONCLUSIONS: Explantation of the DJBL is associated with weight gain and worsening of glycemic control, although some beneficial effects remained detectable 12 months after explantation. A change in strategy is needed to preserve the beneficial effects of DJBL treatment. (Clinical trial registration number: 746∖100111.).

The value of serum antibodies in differentiating inflammatory bowel disease, predicting disease activity and disease course in the newly diagnosed patient.

BACKGROUND: Data on serum antibodies in untreated adult inflammatory bowel disease (IBD) patients at diagnosis are scarcely available, and results on the stability of antibody presence over time are inconsistent. Our aim was to investigate antibodies in newly diagnosed, untreated IBD patients in relation to disease phenotype and course. Furthermore, we analyzed antibody presence over time. METHODS: Baseline anti-Saccharomyces cerevisiae antibodies (ASCA), anti-chitobioside carbohydrate antibodies (ACCA), anti-laminaribioside carbohydrate antibodies (ALCA) and anti-mannobioside carbohydrate antibodies (AMCA) were measured with enzyme-linked immunosorbent assays and perinuclear anti-neutrophilic cytoplasmic antibodies (pANCA) was measured by indirect immunofluorescence in serum of 120 untreated IBD patients at diagnosis and 19 healthy controls. Antibodies were related to disease outcomes. Serial measurements were available in 71 patients. RESULTS: The combination of pANCA and ASCA enabled good discrimination between UC and CD (p = .004). Antibody presence was relatively stable over time, even though there were significant changes in concentrations. There was a trend towards larger fluctuations in concentration with immunosuppressive medication. Baseline pANCA in UC patients correlated with calprotectin values (rho = .545, p = .019) and change in pANCA status over time was associated with disease activity at that moment. No associations were found with antibodies at diagnosis and disease outcomes. CONCLUSION: Antibody profiles at diagnosis support the distinction between CD and UC. Anti-glycan antibodies are reasonably stable over time, but may fluctuate under the influence of immunosuppressive treatment which may explain the inconsistency in findings hitherto. The appearance or disappearance of pANCA antibodies during follow-up correlated with disease activity in UC and may be used in disease monitoring.

Weight reduction and improvement in diabetes by the duodenal-jejunal bypass liner: a 198 patient cohort study.

BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is an endoscopic treatment for patients with type 2 diabetes mellitus (T2DM) and (morbid) obesity. The aim of the current study was to determine its efficacy and safety profile. METHODS: Inclusion criteria for treatment with a DJBL were: age 18-70 years, BMI 28-45 kg/m2, and T2DM with a HbA1c > 48 mmol/mol. Primary outcomes were changes in HbA1c and body weight. Secondary outcomes included changes in blood pressure, lipids, and anti-diabetic medication. Predictive factors for success of treatment with the DJBL were determined. RESULTS: Between 2011 and 2014, 185 out of 198 patients successfully underwent a DJBL implantation procedure, with an intended implantation time of 12 months. In these 185 patients, body weight decreased by 12.8 ± 8.0 kg (total body weight loss of 11.9 ± 6.9 %, p < 0.001), HbA1c decreased from 67 to 61 mmol/mol (p < 0.001) despite a reduction in anti-diabetic medication, and blood pressure and serum lipid levels all decreased. In total, 57 (31 %) DJBLs were explanted early after a median duration of 33 weeks. Adverse events occurred in 17 % of patients. C-peptide ≥1.0 nmol/L and body weight ≥107 kg at screening were independent predictive factors for success. CONCLUSIONS: Treatment with the DJBL in T2DM patients with (morbid) obesity results in improvement in glucose control, a reduction in anti-diabetic medication, and significant weight loss. The largest changes are observed within the first 3-6 months. Initial C-peptide levels and body weight may help to select patients with the greatest chance of success.

Cost Efficacy of Metal Stents for Palliation of Extrahepatic Bile Duct Obstruction in a Randomized Controlled Trial.

BACKGROUND & AIMS: Endoscopic stents are placed for palliation of extrahepatic bile duct obstruction. Although self-expandable metal stents (SEMS) remain patent longer than plastic stents, they are more expensive. We aimed to evaluate which type of stent (plastic, uncovered SEMS [uSEMS], or partially covered SEMS [pcSEMS]) is the most effective and we assessed costs. METHODS: We performed a multicenter randomized trial in 219 patients at 18 hospitals in The Netherlands from February 2008 through February 2013. Patients were assigned randomly for placement of a plastic stent (n = 73), uSEMS (n = 75), or pcSEMS (n = 71) during endoscopic retrograde cholangiopancreatography. Patients were followed up for up to 1 year. Researchers were not blinded to groups. The main study end points included functional stent time and costs. RESULTS: The mean functional stent times were 172 days for plastic stents, 288 days for uSEMS, and 299 days for pcSEMS (P < .005 for uSEMS and pcSEMS vs plastic). The initial placement of plastic stents (€1042 or $1106) cost significantly less than placement of SEMS (€1973 or $2094) (P = .001). However, the total cost per patient at the end of the follow-up period did not differ significantly between plastic stents (€7320 or $7770) and SEMS (€6932 or $7356) (P = .61). Furthermore, in patients with short survival times (≤3 mo) or metastatic disease, the total cost per patient did not differ between plastic stents and SEMS. No differences in costs were found between pcSEMS and uSEMS. CONCLUSIONS: Although placement of SEMS (uncovered or partially covered) for palliation of extrahepatic bile duct obstruction initially is more expensive than placement of plastic stents, SEMS have longer functional time. The total costs after 1 year do not differ significantly with stent type. Dutch Clinical Trial Registration no: NTR1361.

Safety experience with the duodenal-jejunal bypass liner: an endoscopic treatment for diabetes and obesity.

BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is a new, device-based endoscopic treatment for type 2 diabetes mellitus (T2DM) and obesity. OBJECTIVE: To report serious safety events of subjects treated with the DJBL while offering a simple guideline to mitigate risk. DESIGN: Single-center observational study. SETTING: Tertiary referral center. PATIENTS: For commercial use, patients were eligible for implantation of the DJBL when they met the following criteria: age 18 to 65 years, body mass index 28 to 45 kg/m(2), T2DM, and negative serum Helicobacter pylori test. INTERVENTIONS: Endoscopic implantation of the DJBL. MAIN OUTCOME MEASUREMENTS: Adverse events, serious adverse events, early explantation. RESULTS: Between October 2007 and January 2014, 152 of 165 planned implantations (92%) and 94 explantations were performed in our center. Significant weight loss and improvement in T2DM and other cardiovascular parameters were achieved. Early removal of the device occurred because of persistent GI symptoms in 16 patients (11%). Serious adverse events were observed in a subset of patients: 7 GI bleeds, 5 of which required early removal; 2 cases of pancreatitis; 1 case of hepatic abscess; and 1 obstruction of the sleeve. Explantation resulted in an esophageal tear in 2 cases. LIMITATIONS: Single-center study. CONCLUSION: The DJBL improves glycemic control while causing weight loss. The safety profile of the DJBL demonstrates a reasonable tolerability profile. However, serious safety adverse events can occur. Patient selection, expert use of the device at placement and removal, and the supportive care of an experienced multidisciplinary team are key for safe and effective use of the DJBL.

Acute pancreatitis as an adverse event in patients with the duodenal-jejunal bypass liner.

Placement of the duodenal-jejunal bypass liner (DJBL) is a minimally invasive technique for the management of patients with type 2 diabetes mellitus and obesity. Acute pancreatitis was seen in 5 of 167 patients (3 %) in our series. It is suggested that acute pancreatitis in patients with the DJBL results from either direct blockage or edema of the major duodenal papilla, which may be caused by the following: migration of the anchor of the DJBL, accumulation of food debris between the liner and the duodenal wall, or reflux of duodenal contents into the pancreatic duct due to intraluminal hypertension caused by the liner. Early removal of the DJBL resulted in fast and complete recovery, whereas delayed diagnosis and removal led to severe, necrotizing acute pancreatitis.

Prospective evaluation of ERCP performance: results of a nationwide quality registry.

BACKGROUND AND STUDY AIMS: Despite significant interest from health care authorities, patient organizations, and insurance companies, data on procedural outcome and quality of endoscopic retrograde cholangiopancreatography (ERCP) in general and academic practice are sparse. The aims of this study were to assess procedural outcome of ERCP within a large prospective registry in The Netherlands, and to evaluate associations between endoscopist-related factors and procedural outcome. METHODS: All endoscopists performing ERCP in The Netherlands were invited to register their ERCPs over a 1-year period using the Rotterdam Assessment Form for ERCP (RAF-E). The primary outcome measure was procedural success. A priori difficulty level of the procedure was classified according to Schutz. Baseline characteristics of the endoscopist (e. g. previous experience) were recorded at study entry. Regression analysis was performed to identify predictors of procedural outcome. RESULTS: A total of 8575 ERCPs were registered by 171 endoscopists from 61 centers, constituting about 50 % of all ERCPs performed nationally during the study period. Overall procedural success was 85.8 %. Intact papillary anatomy was present in 5106 patients (59.5 %): procedural success in this subgroup of patients was 83.4 % vs. 89.4 % after sphincterotomy (P < 0.001). Multivariate logistic regression identified "degree of difficulty," "intact papillary anatomy," and "previous ERCP failure" to be independently associated with procedural failure. "Yearly volume of ERCPs" and "trainee involvement" were independently associated with success. CONCLUSIONS: The nationwide prospective RAF-E registry proved to be a valuable tool to gain insight into procedural outcome of ERCPs.

The feasibility of delivering a duodenal-jejunal bypass liner (EndoBarrier) endoscopically with patients under conscious sedation.

BACKGROUND: The endoscopically placed duodenal-jejunal bypass liner (DJBL) or EndoBarrier gastrointestinal liner has been designed for the treatment of type 2 diabetes mellitus and simultaneous achievement of weight loss by obese patients. This study was performed to determine the safety, efficacy, and feasibility of delivering the DJBL with the patient under conscious sedation (CS). The primary end points of the study were safety and complications. The secondary end points were delivery time (min), amount of propofol (mg) used, and the total hospital stay (h). METHODS: This prospective study compared placement of the DJBL with the patient under propofol sedation and placement with the patient under general anesthesia (GA). The study included 56 patients, with 28 patients in each group. RESULTS: Both groups were comparable in terms of age, gender, and body mass index. All the devices were placed successfully, and no complications occurred in either group. Comparison of the CS group with the GA group respectively showed a mean total operation time of 29 versus 56 min, a mean propofol use of 170 versus 258 mg, and a mean hospital stay of 11 versus 22 h. CONCLUSION: Delivery of the DJBL to patients under CS is feasible, safe, and efficient in terms of time and cost. Because of possible complications during the procedure, the authors recommend placement of the DJBL with the patient under CS in proximity to the operating room.

External Validity and Consistency over Time of Patient Segmentation Based on Disease Acceptance and Perceived Control in Inflammatory Bowel Disease.

BACKGROUND AND AIMS: The patient segmentation model based on disease acceptance and perceived control may guide personalized care in inflammatory bowel disease (IBD). We aimed to investigate the external validity of the segmentation model and its consistency over time. METHODS: This is a multicenter longitudinal cohort study of adult IBD patients with questionnaires on disease acceptance and perceived control (6-items, 7-point Likert scale) and health-related quality of life (HRQoL) (Short IBD questionnaire, range 10-70). Segments were created based on mean scores (cut-off>5): (I) high acceptance, high control; (II) high acceptance, low control; (III) low acceptance, high control and; (IV) low acceptance, low control. RESULTS: The external validation cohort included 921 IBD patients. The acceptance and control scale were unidimensional and internally consistent. Segments differed significantly in gender, disease duration, IBD medication and clinical disease activity. High acceptance and/or high control were significantly associated with a higher HRQoL compared with low acceptance and low control (i.e., segment IV) (Beta (95%CI) segment I=11.7 (10.4-13.1), segment II=9.3 (7.7-10.9) and segment III=3.8 (1.6-6.0), p≤0.001). The follow-up cohort included 783 patients: 58% remained in the same segment while 42% differed in segment over time. Changes in segment were positively correlated with changes in HRQoL over time (Spearman rho 0.38, p<0.001). CONCLUSIONS: The patient segmentation model based on disease acceptance and perceived control was externally valid and showed consistency over time. The different segments were independently associated with HRQoL. Future interventions should aim to personalize care based on segments and improve disease acceptance and perceived control of IBD patients.

Mucosal α4ß7+ Lymphocytes and MAdCAM+ Venules Predict Response to Vedolizumab in Ulcerative Colitis.

BACKGROUND: Therapeutic strategies for patients with ulcerative colitis (UC) are based on patient- and disease-related factors in combination with drug characteristics but fail to predict success in individual patients. A considerable proportion of UC patients do not respond to the biological vedolizumab. Therefore, pretreatment biomarkers for therapeutic efficacy are urgently needed. Mucosal markers related to the integrin-dependent T lymphocyte homing could be potent predictors. METHODS: We prospectively included 21 biological- and steroid-naive UC patients with moderate-to-severe disease activity planned to escalate therapy to vedolizumab. At week 0, before initiating treatment, colonic biopsy specimens were obtained for immunophenotyping and immunohistochemistry. Clinical and endoscopic disease activity were determined at week 16 after 4 infusions of vedolizumab. In addition, we retrospectively included 5 UC patients who were first treated with anti-tumor necrosis factor α before receiving vedolizumab to compare with biological-naive patients. RESULTS: Abundance of α4ß7 on more than 8% of all CD3+ T lymphocytes in colonic biopsies at baseline was predictive for responsiveness to vedolizumab (sensitivity 100%, specificity 100%). The threshold for the proportion of MAdCAM-1+ and PNAd+ of all venules in the biopsies predictive for responsiveness to vedolizumab was ≥2.59% (sensitivity 89%, specificity 100%) and ≥2.41% (sensitivity 61%, specificity 50%), respectively. At week 16, a significant decrease of α4ß7+CD3+T lymphocytes was demonstrated in responders (18% [12%-24%] to 8% [3%-9%]; P = .002), while no difference was seen in nonresponders (4% [3%-6%] to 3%; P = .59). CONCLUSIONS: UC responders to vedolizumab have a higher percentage of α4ß7+CD3+ T lymphocytes and a higher proportion of MAdCAM-1+ venules in colonic biopsies than nonresponders before initiating therapy. Both analyses could be promising predictive biomarkers for therapeutic response and may lead to more patient tailored treatment in the future.

Routine screening for colon cancer after conservative treatment of diverticulitis.

BACKGROUND AND AIMS: It is generally advised to perform colonoscopy after conservatively treated diverticulitis because colon cancer may present itself with similar symptoms, laboratory and radiological results. With this study we investigated in what percentage of patients a malignancy was found by performing routine colonoscopy or radiologic imaging after a conservatively treated episode of diverticulitis, and whether this follow-up programme could be reserved for a selected group of patients. METHODS: In our hospital, routine colonoscopy or, as a second choice, radiologic imaging has been standard practice over the last decade. We collected all colonoscopy and radiologic imaging results that were conducted of all 516 patients who were diagnosed with diverticulitis in this period. RESULTS: Of those 516 patients, 378 had undergone colonoscopy, 45 radiologic imaging and 93 did not undergo any additional investigation. Eight cases of malignant neoplasia were found in those patients (2.1%), and an additional number of 40 adenomatous polyps (9.5%). Six out of 8 patients with colon cancer reported rectal blood loss, significant weight loss or persisting abdominal pain after being treated for diverticulitis. CONCLUSIONS: In patients who were conservatively treated with routine colonoscopy or radiologic imaging for apparent diverticulitis, a malignant tumour was found in the colon in 2.1% of them. If only performed in patients reporting alarm symptoms, a case of colon cancer would be missed in only 0.5% of patients conservatively treated for diverticulitis. Therefore, screening for colon cancer after conservative treatment of diverticulitis is only indicated in symptomatic patients.

Improving Care for Recently Diagnosed Inflammatory Bowel Disease Patients: Lessons Learned From a Patient-Centred, Mixed-Method Study.

BACKGROUND AND AIMS: Newly diagnosed inflammatory bowel disease [IBD] patients need to deal with the physical and emotional impact of the disease. We aimed to evaluate care for recently diagnosed IBD patients from the patient perspective and assess themes for improvement. METHODS: A mixed-method study with adult IBD patients 4-15 months after diagnosis was performed. First, relevant themes were identified through semi-structured interviews until data saturation. Next, a questionnaire assessing satisfaction with care [SATI-Q] was developed and validated with 15 items divided into two domains: medical care and information and psychosocial care. Higher scores indicate higher patient satisfaction [0-100]. RESULTS: We interviewed 20 patients. Next, 84/107 patients completed the SATI-Q: 51% female, aged 37 years (interquartile range [IQR 25-58]), 36% Crohn's disease, disease duration 9 months [IQR 6-12] and 74% in clinical remission. The median SATI-Q score was 82 [IQR 72-92]. Patients were more satisfied with medical care than with information and psychosocial care (score 92 [IQR 81-98] vs 74 [IQR 60-90], p < 0.001). Patients were least satisfied with the attention given to IBD-related emotions and information on IBD medication, diet and future perspectives [77, 76, 57 and 54% of patients satisfied]. Patients [81%] preferred spoken information. Only 26-27% preferred brochures and websites. CONCLUSIONS: In this study, the SATI-Q questionnaire was developed and validated to assess patient satisfaction with care in early IBD. Our findings suggest that psychosocial care and information on IBD medication, diet influence and future perspectives for recently diagnosed IBD patients require improvement.

Acceptance and Perceived Control are Independently Associated With Quality of Life in Inflammatory Bowel Disease: Introduction of a New Segmentation Model.

BACKGROUND AND AIMS: Segmentation of patients based on psychological determinants of subjective health may provide new ways to personalized care. The cross-disease segmentation model developed by Bloem & Stalpers discriminates patients based on disease acceptance and perceived control. We aimed to validate the segmentation model, compare segments and evaluate whether segments independently correlate with quality of life in inflammatory bowel disease [IBD]. METHODS: A cross-sectional study of adult IBD patients was performed with questionnaires on quality of life [32-item inflammatory bowel disease questionnaire], acceptance and perceived control [six items with 7-point Likert scale]. Four segments were formed [cut-off > 5]: [I] high acceptance, high control; [II] high acceptance, low control [III]; low acceptance, high control and; [IV] low acceptance, low control. RESULTS: We included 686 patients. The acceptance and perceived control scales were unidimensionally structured and internally consistent. Segments differed significantly in age, smoking behaviour, diagnosis, disease duration, extra-intestinal manifestations, IBD medication, clinical disease activity and quality of life. High acceptance (standardized beta coefficient [ß] 0.25, p < 0.001), high perceived control [ß 0.12, p < 0.001] or both [ß 0.53, p < 0.001], were associated with a significantly better health-related quality of life compared with low acceptance and low perceived control. Sociodemographic and clinical factors explained 25% of the variance in quality of life. The explained variance significantly increased to 45% when the patients' segment was added to the model [ΔR2 20%, p < 0.001]. CONCLUSIONS: The segmentation model based on disease acceptance and perceived control is valid in IBD patients and discriminates different segments that correlate independently with quality of life. This may open new strategies for patient care.