Development of the Nursing Assessment Tool for the Patient With Inflammatory Bowel Disease.

This study aims to develop and validate a nursing assessment tool for patients with inflammatory bowel disease. In this cross-sectional descriptive study using a quantitative approach, nurses were invited to participate. The Delphi technique was used to obtain a consensus among expert nurses. Descriptive analysis was used for each item on the nursing assessment tool. Overall, 345 nurses were identified; 32 were eligible as experts and 13 validated the consultation. Of the 13 expert nurses, most were female (11, 84.62%), their mean age was 46.36 ± 10.59 years, eight (61.54%) graduated from public institutions, and eight (61.54%) had a master's degree. The initial version had 106 items, which was reduced to 95 items. The content of four domains (identification, health-disease profile, psychobiological needs, and physical examination) was validated in two rounds about the content with more than 80% of agreement. Two domains (sociodemographic data and health conditions, and personal cares) were validated in the first round with more than 80% of agreement. All domains were validated for their appearance during the first round with more than 80% of agreement. The Nursing Assessment Tool for Patients with Inflammatory Bowel Disease (IBD) had a considerable level of agreement regarding content and appearance validation in all dimensions.

Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB).

BACKGROUND: Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian patients with UC, and evaluate factors associated with clinical and endoscopic remission after 1 year of treatment. METHODS: A national retrospective multicenter study (24 centers) was performed including patients with UC treated with anti-TNF therapy. Outcomes as clinical response and remission, endoscopic remission and secondary loss of response were measured in different time points of the follow-up. Baseline predictive factors of clinical and endoscopic remission at week 52 were evaluated using logistic regression model. Indirect comparisons among groups (ADA and IFX) were performed using Student's t, Pearson χ2 or Fisher's exact test when appropriated, and Kaplan Meier analysis. RESULTS: Overall, 393 patients were included (ADA, n = 111; IFX, n = 282). The mean age was 41.86 ± 13.60 years, 61.58% were female, most patients had extensive colitis (62.40%) and 19.39% had previous exposure to a biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65%, p < 0.0001) and 52 (65.24% vs. 51.35%, p < 0.0001) when compared to ADA. According to Kaplan-Meier survival curve loss of response was less frequent in the Infliximab compared to Adalimumab group (p = 0.001). Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). Age, non-prior exposure to biological therapy, use of IFX and endoscopic remission at week 26 were associated with clinical remission after 52 weeks. Variables associated with endoscopic remission were non-prior exposure to biological therapy, and clinical and endoscopic remission at week 26. CONCLUSIONS: IFX was associated with higher rates of clinical remission after 1 year in comparison to ADA. Non-prior exposure to biological therapy and early response to anti-TNF treatment were associated with higher rates of clinical and endoscopic remission.

Perception and clinical decisions from inflammatory bowel diseases' specialists towards positioning of new therapies in Crohn's disease and ulcerative colitis: A national web-based survey from the Brazilian IBD study group (GEDIIB).

BACKGROUND: In the last decade, new therapies with different mechanisms of action have been approved for the treatment of moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). Due to the lack of comparative head-to-head trials, the ideal positioning of agents as the most appropriate first- or second-line therapies remains to be defined. OBJECTIVE: This survey aimed to evaluate the perception and decisions of Brazilian Inflammatory Bowel Diseases (IBD) specialists in positioning of new therapies (vedolizumab [VEDO], ustekinumab [UST] and tofacitinib [TOFA]) in the management of IBD in different clinical scenarios. METHODOLOGY: An anonymous national web-based questionnaire was used to determine the positioning of treatment options in different clinical scenarios (using Google Forms platform), which involved different age ranges, phenotypes, clinical situations and previous exposure to anti-TNF agents (14 scenarios for CD and 10 scenarios for UC). In CD, physicians could choose between UST or VEDO, whilst in UC, between UST, VEDO or TOFA. Six reasons for the specific choice were proposed, such as mechanism of action, safety, method of administration or onset of action. Statistical analysis was carried out with chi-square and t-tests. RESULTS: A total of 150 out of 672 GEDIIB IBD specialists (22.32%) responded to the survey. In CD scenarios, UST was the most dominant choice (11/14 scenarios), with VEDO dominating only 3 clinical situations. In UC scenarios, VEDO was the dominant choice (8/10), with UST being chosen for scenarios that included extraintestinal manifestations. Among the reasons for specific choices, the most commonly chosen were the higher efficacy due to the intrinsic mechanism of action and safety profile. CONCLUSIONS: UST was the dominant choice as compared to VEDO in CD in most scenarios, especially due to its mechanism of action and safety. VEDO was the dominant choice as compared to UST and TOFA in UC scenarios, mainly for reasons also related to its mechanism of action and safety profile. Comparative studies including patient outcomes are needed to better define the positioning of new IBD therapeutic options in our country.

P045 Prevalence of non-alcoholic fatty liver disease (NAFLD) in patients with inflammatory bowel disease (IBD) in a Brazilian public healthcare clinic.

BACKGROUND: Inflammatory Bowel Disease (IBD) is an inflammatory and chronic disease, as well as non-alcoholic fatty liver disease (NAFLD). Current literature has shown that IBD patients are at high risk for NAFLD. In those patients, the pathogenesis of NAFLD may be more complex and related to multifactor causes, such as gut dysbiosis, unhealthy nutritional behavior, body composition and systemic inflammation. There is an increase in NAFLD's incidence in the general population, otherwise, there are few studies evaluating NAFLD prevalence in IBD patients. So, this study aimed to evaluate prevalence of NAFLD and identify the clinical factors associated with the presence of NAFLD in patients with IBD. METHODS: This cross-sectional, descriptive, observational study included 71 IBD patients from an IBD public outpatient in São Paulo State, Brazil. Laboratory evaluation and clinical data were collected. The presence of NAFLD was evaluated by ultrasonography. The exclusion criteria were as follows: pre-existing liver disease, history of alcohol intake >20g/day for women and >30g/day for men, and glucocorticoids treatment >20mg/day. Statistical analysis: descriptive statistics and association tests. RESULTS: 71 patients were included, of which 34 (47.89%) were Crohn´s disease (CD) and 37 (52.11%) ulcerative colitis (UC). Median age was 45.32±13.59 years, 63.38% were female, 69.1% Caucasian, 7.04% smokers. The time from diagnosis was 12.55 ± 8.01 years. Regarding the characteristics of the diseases, 42.42% of patients with CD have ileocolonic involvement, 50% penetrating disease and 39.4% perianal involvement. In relation to patients with UC, most patients have pancolitis (72.22%). Mostly, the patients were in clinical (63.89%) and endoscopic (52.86%) remission. Regarding medical treatment, the most used drugs were biological therapy (79.41%) and azathioprine (52.94%) in CD, and mesalazine (45.95%), azathioprine (40.54%) and biological therapy (40.54%) in UC. The NAFLD group consists of 32 (45.07%) patients: 40.63% had mild steatosis; 40.63% moderate and 18.65% intense NAFLD. Development of NAFLD vs no NAFLD was associated with body mass index (29.49 ± 3.93 vs 24.32 ± 3.85, p < 0.0001), and laboratory biomarkers, such as C-reactive protein (1.99 ± 4.39 vs 0.87 ± 0.52, p = 0.0061), AST (29.72 ± 16.64 vs 23.46 ± 5.31, p = 0.0226), ALT (24.92 ± 14.22 vs 17.92 ± 6.57, p = 0.0099), albumin (4.1 ± 0.37 vs 4.36 ± 0.32, p = 0.0415), fasting glucose (95.5 ± 14.01 vs 84.36 ± 13.01, p = 0.0251) and blood insulin (18.41 ± 11.88 vs 6.4 ± 4.26, p = 0.0054). Also, the NAFLD group had higher prevalence of systemic arterial hypertension (31.25% vs 10.26%, p = 0.0369). When comparing patients with the presence or absence of NAFLD, there was no difference between the groups regarding time since diagnosis (p = 0.9684), previous surgery (p = 0.5908), Montreal classification, clinical activity assessed by CDAI (p = 0.2258), clinical activity assessed by the Mayo score (p = 0.4935), endoscopic activity (p = 0.0599), histological activity (p = 1.0), or medical treatment. CONCLUSION: Development of NAFLD is a frequent occurrence in patients with IBD. NAFLD group had higher levels of body mass index, C-reactive protein, AST, ALT, fasting glucose and blood insulin, which are also associated with metabolic syndrome. Early diagnosis and appropriate nutritional orientation are necessary to prevent NAFLD related complications.

P049 Investigation of Liver Diseases by Ultrasound in Patients With Inflammatory Bowel Disease.

BACKGROUND: Inflammatory Bowel Disease (IBD), which can be divided into Crohn's Disease (CD) and Ulcerative Colitis (UC), is an immune mediated disease featured by gastrointestinal tract involvement. Hepatic disease, such as non-alcoholic fatty liver disease (NAFLD), cirrhosis, cholelithiasis, hepatic thromboembolic events and primary sclerosing cholangitis (PSC) are some hepatic complications presented by IBD patients. Since these hepatic disorders have a higher prevalence in IBD patients, ultrasonography is a noninvasive low-cost versatile tool, that allows to identify these manifestations at early stages. Therefore, this study aims to analyze the prevalence of hepatic diseases in patients with IBD. METHODS: A cross-sectional study was performed in a single IBD center, Brazil. This study considered clinical and sociodemographic data of these individuals, besides the evaluation of disease activity, biochemical tests, and liver ultrasound with doppler. Statistical analysis: descriptive, association tests. RESULTS: 71 patients were included, 34 had CD and 37 had UC, mean age 45.32 ± 13.59 years, 63.38% women. Among CD patients, 42.42% have ileocolonic involvement, 50% penetrating behavior and 39.4% perianal involvement. Among patients with UC, most patients have pancolitis (72.22%). Most patients were in clinical (CD: 93.55%, UC: 63.89%) and endoscopic (47.14%) remission. The main medications used were azathioprine (46.48%), infliximab (40.85%), salicylates (28.17%), corticosteroids (16.9%) and adalimumab (11.27%). According to ultrasound, NAFLD was found in 32 (45.07%) patients: 40.63% mild, 40.63% moderate and 18.75% severe. Furthermore, we found a correlation between liver steatosis and blunt liver edge (p < 0.0155). Only 2 patients presented with choledocholithiasis. One patient had features of chronic liver disease such as irregular surface, heterogeneity of a hepatic parenchymal echo and bluntness of the liver edge. No signs of thrombosis were found in portal, splenic or superior mesenteric veins. CONCLUSION: A higher prevalence of NAFLD was found in patients with IBD, and no signs of thrombosis were found in the splanchnic system.

P052 National Registration of Patients With Inflammatory Bowel Disease in Brazil on Behalf of GEDIIB.

BACKGROUND: The IBD National Patient Registry is an initiative of the GEDIIB (Brazilian Study Group of Inflammatory Bowel Disease) who aims to survey the epidemiological profile of IBD patients through the creation of a centralized registry with data on patients monitored in public and private health services which will allow the planning of actions by the GEDIIB to facilitate the diagnosis and access to treatment of IBD, enabling the implementation of actions of the GEDIIB and the partnership with government agencies to improve care and, consequently, the quality of life of patients with IBD. This study aims to show the results of the IBD National Patient Registry. METHODS: A cohort study was performed. Data were collected from July 2020 to August 2021. Data were obtained from medical records and/or from patients during the regular follow-up visit and stored in pre-established records for further analysis. Only patients with an established diagnosis of CD and UC were included. The study was approved by the local ethical committees and all patients signed the consent form. RESULTS: In total, 797 patients were included, 60% with UC and 40% with CD; 52.9% from University Hospitals. The mean age was 44.75 ± 16.11 (12 - 92y), 59.9% female, 59.3% married, 76.4% Caucasian, 85.1% non-smokers, 30.5% completed higher education, 14.9% presented familial history of IBD. The age of onset of symptoms ranged from 3 - 79 years (32.94 ± 14.22) and 33.2% presented diarrhea as an initial manifestation. The age of diagnosis ranged from 4 - 81 years (35.07 ± 14.60) and the time from symptoms to diagnosis ranged from 1 to 2 years. The Montreal classification of CD patients were A1: 6.3%, A2: 59.9%, A3: 33.8%; L1: 38%, L2: 16.7%, L3: 43.9%, B1: 51.5%, B2: 27.8%, B3: 7.8%; perianal 12.8%. In UC, 47.8% presented pancolitis, 30.3% left-sided and 21.8% distal colitis. EIMs were present in 45.7% of patients, the most frequent being rheumatological 21.8%. Comorbidities were present in 72%, the most frequent were high blood pressure (15.3%) and diabetes (6.3%); 50% were with BMI > 25 Kg/m2. Most of the patients were in use of medical therapy (95.5%), of which 81.3% salicylate, 70.3% biological therapy, 49% immunosuppressor, 25.6% corticosteroid and 1.2% tofacitinib. Regarding biological therapy, the following medications were used: infliximab 47.6%, adalimumab 28.4%, vedolizumab 9.5%, ustekinumab 7.5%, certolizumab 2.2% and golimumab 1.3%. Eleven women used the medication during pregnancy. IBD surgery-related was performed in 69.7%, 77.2% abdominal and 22.8% perianal. Almost 30% performed more than one surgery. In 62% of patients, at least one complication was reported; most of them were infective disorders, demanding prolonged hospitalizations. CONCLUSION: To date, there is no IBD epidemiologic study covering the entire Brazilian territory. The results found with the registry will be fundamental to show the epidemiology of a country with continental dimensions such as Brazil. The greater the number of researchers included and from different regions of the country, the greater the representativeness of the data and may even help direct government actions on behalf of IBD patients.

Progression of Inflammatory Bowel Diseases Throughout Latin America and the Caribbean: A Systematic Review.

BACKGROUND & AIMS: The incidence of inflammatory bowel diseases (IBD) is increasing in Latin America. We performed a systematic review to identify clinical and epidemiologic features of IBD in Latin America (including Mexico, Central America, and South America) and the Caribbean. METHODS: We searched MEDLINE, EMBASE, and SciELO databases for clinical or epidemiologic studies of Crohn's disease (CD) or ulcerative colitis (UC) from Latin American and Caribbean countries and territories that reported incidence, prevalence, ratio of UC:CD, IBD phenotype, and treatment, through September 12, 2018. Data were extracted from 61 articles for analysis. RESULTS: The incidence and prevalence of IBD have been steadily increasing in Latin America and the Caribbean. The incidence of CD in Brazil increased from 0.08 per 100,000 person-years in 1988 to 0.68 per 100,000 person-years in 1991-1995 to 5.5 per 100,000 person-years in 2015. The highest reported prevalence of IBD was in Argentina, in 2007, at 15 and 82 per 100,000 person-years for CD and UC, respectively. The ratio of UC:CD exceeded 1 in all regions throughout Latin America and the Caribbean with the exception of Brazil. Treatment with tumor necrosis factor antagonists increased steadily for patients with CD (43.4% of all patients in Brazil were treated in 2014) but less so for patients with UC (4.5% of all patients were treated in 2014). Surgery for IBD decreased with time. In Chile, surgeries were performed on 57.0% of patients with CD and 18.0% of patients with UC during the period of 1990-2002; these values decreased to 38.0% and 5.0%, respectively, during the period of 2012-2015. In Peru, 6.9% of patients with UC received colectomies in the period of 2001-2003 and 6.2% in 2004-2014. CONCLUSIONS: In a systematic review, we found the incidence of IBD to be increasing throughout Latin America and the Caribbean. Population-based epidemiology studies are needed to evaluate the increase in IBD in these regions, which differ from other global regions in climate, culture, demographics, diet, healthcare delivery and infrastructure, and socioeconomic status.

Simulation-based rhomboid flap skills training during medical education: comparing low- and high-fidelity bench models.

OBJECTIVE: To assess if the bench model fidelity interferes in the acquisition of rhomboid flap skills by medical students. METHODS: Sixty novice medical students were randomly assigned to 5 practice conditions with instructor-directed Limberg rhomboid flap skills training: didactic materials (control group 1), low-fidelity rubberized line (group 2) or ethylene-vinyl acetate (group 3) bench models; high-fidelity chicken leg skin (group 4) or pig foot skin (group 5) bench models. Pretests and posttests were applied, and Global Rating Scale, effect size, and self-perceived confidence were used to evaluate all flap performances. RESULTS: Medical students from groups 2 to 5 showed better flap performances based on the Global Rating Scale (all P < 0.05) and felt more confident to perform rhomboid flaps (all P < 0.05) compared to their peers from control group 1, regardless of bench model fidelity (all P > 0.05). The magnitude of the effect was considered large (>0.80) in all measurements. CONCLUSION: There was acquisition of rhomboid flap skills regardless of bench model fidelity.

Vedolizumab Safety During Pregnancy and Lactation in a Patient with Ulcerative Colitis: A Case Report.

Background: Inflammatory bowel disease (IBD) affects young adults of reproductive age, and questions related to pregnancy and breastfeeding are common in clinical practice. Most medications used to treat IBD are considered safe during pregnancy, except methotrexate and small molecules such as tofacitinib. Despite few studies regarding vedolizumab (VDZ) safety, it appears to be safe during pregnancy. Therefore, this study aimed to report the management of ulcerative colitis in pregnant patient refractory to anti-tumor necrosis factor (TNF) agents using VDZ. Case Report: A female, 38 years old, with ulcerative colitis was refractory to conventional treatment with mesalazine, sulfasalazine, and azathioprine. She was hospitalized at six weeks of gestation with severe acute colitis requiring the use of infliximab (IFX) to induce remission. She had a spontaneous abortion at nine weeks of gestation after the second dose of IFX. Since there was no endoscopic improvement after six months of IFX treatment, VDZ treatment was initiated. During the VDZ infusion period, the patient discovered that she was pregnant with twins, leading to the discussion of the risks and benefits of continuing the VDZ. The patient presented with disease clinical remission with the use of VDZ, and the babies were born at 34 weeks of gestation without complications. Breastfeeding was also performed without complications. Conclusion: Continued VDZ medication is safe during pregnancy and breastfeeding, with adverse events similar to anti-TNF therapy.

microRNA-mRNA Networks Linked to Inflammation and Immune System Regulation in Inflammatory Bowel Disease.

The molecular processes linked to the development and progression of Crohn's disease (CD) and ulcerative colitis (UC) are not completely understood. MicroRNAs (miRNAs) regulate gene expression and are indicated as diagnostic, prognostic, and predictive biomarkers in chronic degenerative diseases. Our objectives included the identification of global miRNA expression in CD and UC, as well as miRNA target genes, miRNA-mRNA interaction networks, and biological functions associated with these different forms of inflammatory bowel disease (IBD). METHODS: By performing a comprehensive meta-analysis, we integrated miRNA expression data from nine studies in IBD. We obtained detailed information on significantly deregulated miRNAs (fold change, FC ≥ 2 and p < 0.05), sample type and number, and platform applied for analysis in the training and validation sets. Further bioinformatic analyses were performed to identify miRNA target genes, by using the microRNA Data Integration Portal tool. We also sought to identify statistically enriched pathways of genes regulated by miRNAs using ToppGene Suite. Additional analyses were performed to filter for genes expressed in intestinal tissue using the European Bioinformatics Institute (EBI) database. RESULTS: Our findings showed the upregulation of 15 miRNAs in CD and 33 in UC. Conversely, six miRNAs were downregulated in CD, while seven were downregulated in UC. These results indicate a greater deregulation of miRNAs in UC compared to CD. Of note, miRNA target genes were enriched for immune system regulation pathways. Among significantly deregulated miRNAs with a higher number of miRNA-target gene interactions, we identified miR-199a-5p and miR-362-3p altered in CD, while among UC case patients, miRNA-target gene interactions were higher for miR-155-5p. CONCLUSIONS: The identified miRNAs play roles in regulating genes associated with immune system regulation and inflammation in IBD. Such miRNAs and their target genes have the potential to serve as clinically relevant biomarkers. These findings hold promise for enhancing the accuracy of diagnoses and facilitating the development of personalized treatment strategies for individuals with various forms of IBD.

Clinical factors associated with severity in patients with inflammatory bowel disease in Brazil based on 2-year national registry data from GEDIIB.

The Brazilian Organization for Crohn's Disease and Colitis (GEDIIB) established a national registry of inflammatory bowel disease (IBD). The aim of the study was to identify clinical factors associated with disease severity in IBD patients in Brazil. A population-based risk model aimed at stratifying the severity of IBD based on previous hospitalization, use of biologics, and need for surgery for ulcerative colitis (UC) and Crohn's Disease (CD) and on previous complications for CD. A total of 1179 patients (34.4 ± 14.7y; females 59%) were included: 46.6% with UC, 44.2% with CD, and 0.9% with unclassified IBD (IBD-U). The time from the beginning of the symptoms to diagnosis was 3.85y. In CD, 41.2% of patients presented with ileocolic disease, 32% inflammatory behavior, and 15.5% perianal disease. In UC, 46.3% presented with extensive colitis. Regarding treatment, 68.1%, 67%, and 47.6% received biological therapy, salicylates and immunosuppressors, respectively. Severe disease was associated with the presence of extensive colitis, EIM, male, comorbidities, and familial history of colorectal cancer in patients with UC. The presence of Montreal B2 and B3 behaviors, colonic location, and EIM were associated with CD severity. In conclusion, disease severity was associated with younger age, greater disease extent, and the presence of rheumatic EIM.

INTERACTION BETWEEN FOOD PYRAMID AND GUT MICROBIOTA. A NEW NUTRITIONAL APPROACH.

The food pyramid is a pre-established nutritional education tool. The integration between the intestinal microbiome, food groups, and SCFA-producing bacteria, which benefit from the ingestion of these foods, has the potential to further improve and innovate healthy eating. The diet-microbiome interaction needs to be incorporated into nutrition science, and the food pyramid might assist in this interaction and nutritional learning. Against this context, this brief communication proposes through the food pyramid, the interactions between the intestinal microbiota, food groups, and SCFAs-producing bacteria.

Intestinal complications in Brazilian patients with ulcerative colitis treated with conventional therapy between 2011 and 2020.

BACKGROUND: This was an observational, descriptive, and retrospective study from 2011 to 2020 from the Department of Informatics of the Brazilian Healthcare System database. AIM: To describe the intestinal complications (IC) of patients with ulcerative colitis (UC) who started conventional therapies in Brazil´s public Healthcare system. METHODS: Patients ≥ 18 years of age who had at least one claim related to UC 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) code and at least 2 claims for conventional therapies were included. IC was defined as at least one claim of: UC-related hospitalization, procedures code for rectum or intestinal surgeries, and/or associated disease defined by ICD-10 codes (malignant neoplasia of colon, stenosis, hemorrhage, ulcer and other rectum or anus disease, megacolon, functional diarrhea volvulus, intussusception and erythema nodosum). Descriptive statistics, annual incidence, and incidence rate (IR) [per 100 patient-years (PY)] over the available follow-up period were cal-culated. RESULTS: In total, 41229 UC patients were included (median age, 48 years; 65% women) and the median (interquartile range) follow-up period was 3.3 (1.8-5.3) years. Conventional therapy used during follow-up period included: mesalazine (87%), sulfasalazine (15%), azathioprine (16%) or methotrexate (1%) with a median duration of 1.9 (0.8-4.0) years. Overall IR of IC was 3.2 cases per 100 PY. Among the IC claims, 54% were related to associated diseases, 20% to procedures and 26% to hospitalizations. The overall annual incidence of IC was 2.9%, 2.6% and 2.5% in the first, second and third year after the first claim for therapy (index date), respectively. Over the first 3 years, the annual IR of UC-related hospitalizations ranged from 0.8% to 1.1%; associated diseases from 0.9% to 1.2% - in which anus or rectum disease, and malignant neoplasia of colon were the most frequently reported; and procedure events from 0.6% to 0.7%, being intestinal resection and polyp removal the most frequent ones. CONCLUSION: Study shows that UC patients under conventional therapy seem to present progression of disease developing some IC, which may have a negative impact on patients and the burden on the health system.

PROFILE OF INFLAMMATORY BOWEL DISEASE NURSES IN BRAZIL.

•An identification of the profile of inflammatory bowel disease nurses in Brazil was peformed, and only four nurses worked exclusively with patients with inflammatory bowel disease. •The main areas of activity were outpatient clinics and ostomy care. •Nursing care was based on the nursing process, and the main topics approached in these appointments were treatment adherence and ostomy. •Nurses showed knowledge on immunosuppressive medications and biological therapy. Background - Nurses play a fundamental role within the inflammatory bowel disease (IBD) multidisciplinary team. Objective - To identify the profile of IBD nurses in Brazil and their work process organization and characterize the health services where they work. Methods - A questionnaire-based research was developed. The inclusion criteria were nurses with experience in IBD care, nurses with scientific research published in an indexed journal or in process, nurses with master's or doctorate degrees concluded or in progress, and educator nurses with expertise in IBD.Results - Seventy-four nurses were included, among whom 66 (89.19%) were women; their mean age was 40.63±9.98 years. Sixty-six percent work in the Southeast region, and more than half (54.05%) had a specialization course. Only four (5.41%) nurses worked exclusively with patients with IBD. The main areas of activity were outpatient clinics (39%) and ostomy care (35%). Nursing care was based on the nursing process (51.35%), and the main topics approached in nursing appointment were treatment adherence (72.97%), and ostomy (68.92%). Forty-seven (63.51%) nurses had knowledge on immunosuppressive medications and 52 (70.27%) on biological therapy. Most health services were integrated with a hospital that has clinical (72.97%) and surgical hospitalization units (67.57%), and 46 (62.16%) of them had an infusion center. Conclusion - Describing the work process of IBD nurses can supplement their organization of the IBD assistance process, as they do not follow any specific consensus. In addition, the characteristics necessary for IBD care are not found in all health services.

Intestinal complications in patients with Crohn's disease in the Brazilian public healthcare system between 2011 and 2020.

BACKGROUND: This is a secondary database study using the Brazilian public healthcare system database. AIM: To describe intestinal complications (ICs) of patients in the Brazilian public healthcare system with Crohn's disease (CD) who initiated and either only received conventional therapy (CVT) or also initiated anti-tumor necrosis factor (anti-TNF) therapy between 2011 and 2020. METHODS: This study included patients with CD [international classification of diseases - 10th revision (ICD-10): K50.0, K50.1, or K50.8] (age: ≥ 18 years) with at least one claim of CVT (sulfasalazine, azathioprine, mesalazine, or methotrexate). IC was defined as a CD-related hospitalization, pre-defined procedure codes (from rectum or intestinal surgery groups), and/or associated disease (pre-defined ICD-10 codes), and overall (one or more type of ICs). RESULTS: In the 16809 patients with CD that met the inclusion criteria, the mean follow-up duration was 4.44 (2.37) years. In total, 14697 claims of ICs were found from 4633 patients. Over the 1- and 5-year of follow-up, 8.3% and 8.2% of the patients with CD, respectively, presented at least one IC, of which fistula (31%) and fistulotomy (48%) were the most commonly reported. The overall incidence rate (95%CI) of ICs was 6.8 (6.5-7.04) per 100 patient years for patients using only-CVT, and 9.2 (8.8-9.6) for patients with evidence of anti-TNF therapy. CONCLUSION: The outcomes highlighted an important and constant rate of ICs over time in all the CD populations assessed, especially in patients exposed to anti-TNF therapy. This outcome revealed insights into the real-world treatment and complications relevant to patients with CD and highlights that this disease remains a concern that may require additional treatment strategies in the Brazilian public healthcare system.

Adalimumab Serum Concentrations, Clinical and Endoscopic Disease Activity in Crohn's Disease: A Cross-Sectional Multicentric Latin American Study.

Despite some variability in ideal serum Adalimumab (ADA) concentrations, there is increasing evidence that higher concentrations of anti-TNF-α agents can be associated with sustained efficacy, and low or undetectable levels may lead to loss of response. This study aims to correlate serum ADA concentrations with clinical and endoscopic activity in patients with Crohn's disease (CD). A cross-sectional and multicentric study was performed with patients with CD, who used ADA for at least 24 weeks. Patients were allocated into groups according to the presence of clinical or endoscopic disease activity. Serum ADA concentrations were measured and compared between groups. Overall, 89 patients were included. A total of 27 patients had clinically active CD and 62 were in clinical remission. Forty patients had endoscopic disease activity and 49 were in endoscopic remission. The mean serum ADA concentration was 10.2 µg/mL in patients with clinically active CD and 14.3 µg/mL in patients in clinical remission (p = 0.395). The mean serum ADA concentration in patients with endoscopic activity was 11.3 µg/mL as compared to 14.5 µg/mL in those with endoscopic remission (p = 0.566). There was no difference between serum ADA concentrations regarding clinical or endoscopic activity in CD, as compared to patients in remission.

BRAZILIAN CONSENSUS ON THE MANAGEMENT OF INFLAMMATORY BOWEL DISEASES IN PEDIATRIC PATIENTS: A CONSENSUS OF THE BRAZILIAN ORGANIZATION FOR CROHN'S DISEASE AND COLITIS (GEDIIB).

BACKGROUND: Approximately 25% of patients with inflammatory bowel disease (IBD) develop the disease during childhood or adolescence and treatment aims to control active symptoms and prevent long-term complications. The management of Crohn's disease (CD) and ulcerative colitis (UC) can be especially challenging in children and adolescents, related to particularities that may affect growth, development, and puberty. OBJECTIVE: This consensus aims to provide guidance on the most effective medical and surgical management of pediatric patients with CD or UC. METHODS: Experts in Pediatric IBD representing Brazilian gastroenterologists (Brazilian Organization for Crohn's Disease and Colitis [GEDIIB]) developed this consensus. A rapid review was performed to support the recommendations/statements. Medical and surgical recommendations were structured and mapped according to the disease type, disease activity, and indications and contraindications for medical and surgical treatment. After structuring the statements, the modified Delphi Panel methodology was used to conduct the voting. The process took place in three rounds: two using a personalized and anonymous online voting platform and one face-to-face. Whenever participants did not agree with a specific recommendation, an option to explain why was offered to enable free-text responses and provide the opportunity for the experts to elaborate or explain disagreement. The consensus of recommendations in each round was accepted when reached ≥80% agreement. RESULTS AND CONCLUSION: The recommendations are presented according to the stage of treatment and severity of the disease in three domains: management and treatment (drug and surgical interventions), criteria for evaluating the effectiveness of medical treatment, and follow-up/ patient monitoring after initial treatment, follow-up/ patient monitoring after initial treatment. Surgical recommendations were grouped according to disease type and recommended surgery. The target audience for this consensus was general practitioners, gastroenterologists, and surgeons interested in the treatment and management of pediatric CD and UC. Additionally, the consensus aimed to support the decision-making of health insurance companies, regulatory agencies, and health institutional leaders and/or administrators.

SURGICAL MANAGEMENT OF ADULT CROHN'S DISEASE AND ULCERATIVE COLITIS PATIENTS: A CONSENSUS FROM THE BRAZILIAN ORGANIZATION OF CROHN'S DISEASE AND COLITIS (GEDIIB).

BACKGROUND: Despite optimized medical therapy, contemporary risk of surgery in inflammatory bowel diseases (IBD) after 10 years of diagnosis is 9.2% in patients with ulcerative colitis (UC) and 26.2% in Crohn's disease, (CD) in the biological era. OBJECTIVE: This consensus aims to detail guidance to the most appropriate surgical procedures in different IBD scenarios. In addition, it details surgical indications and perioperative management of adult patients with CD and UC. METHODS: Our consensus was developed by colorectal surgeons and gastroenterologists representing the Brazilian Study Group of Inflammatory Bowel Diseases (GEDIIB), with the Rapid Review methodology being conducted to support the recommendations/statements. Surgical recommendations were structured and mapped according to the disease phenotypes, surgical indications, and techniques. After structuring the recommendations/statements, the modified Delphi Panel methodology was used to conduct the voting by experts in IBD surgery and gastroenterology. This consisted of three rounds: two using a personalized and anonymous online voting platform and one face-to-face presential meeting. Whenever participants did not agree with specific statements or recommendations, an option to outline possible reasons was offered to enable free-text responses and provide the opportunity for the experts to elaborate or explain disagreement. The consensus of recommendations/statements in each round was considered to have been reached if there was ≥80% agreement. RESULTS AND CONCLUSION: This consensus addressed the most relevant information to guide the decision-making process for adequate surgical management of CD and UC. It synthesizes recommendations developed from evidence-based statements and state-of-art knowledge. Surgical recommendations were structured and mapped according to the different disease phenotypes, indications for surgery and perioperative management. Specific focus of our consensus was given to elective and emergency surgical procedures, determining when to indicate surgery and which procedures may be the more appropriate. The consensus is targeted to gastroenterologists and surgeons interested in the treatment and management of adult patients with CD or UC and supports decision-making of healthcare payors, institutional leaders, and/or administrators.

Risk factors for major complications after surgical treatment of primary ileocecal Crohn's disease. A multicentric Latin American experience.

INTRODUCTION: Complications after ileocecal resection for Crohn's disease (CD) are frequent. The aim of this study was to analyze risk factors for postoperative complications after these procedures. MATERIALS AND METHODS: We conducted a retrospective analysis of patients treated surgically for Crohn's disease limited to the ileocecal region during an 8-year period at 10 medical centers specialized in inflammatory bowel disease (IBD) in Latin America. Patients were allocated into 2 groups: those who presented major postoperative complications (Clavien-Dindo > II), the "postoperative complication" (POC) group; and those who did not, the "no postoperative complication" (NPOC) group. Preoperative characteristics and intraoperative variables were analyzed to identify possible factors for POC. RESULTS: In total, 337 patients were included, with 51 (15.13%) in the POC cohort. Smoking was more prevalent among the POC patients (31.37 vs. 17.83; P = .026), who presented more preoperative anemia (33.33 vs. 17.48%; P = .009), required more urgent care (37.25 vs. 22.38; P = .023), and had lower albumin levels. Complicated disease was associated with higher postoperative morbidity. POC patients had a longer operative time (188.77 vs. 143.86 min; P = .005), more intraoperative complications (17.65 vs. 4.55%; P < .001), and lower rates of primary anastomosis. In the multivariate analysis, both smoking and intraoperative complications were independently associated with the occurrence of major postoperative complications. CONCLUSION: This study shows that risk factors for complications after primary ileocecal resections for Crohn's disease in Latin America are similar to those reported elsewhere. Future efforts in the region should be aimed at improving these outcomes by controlling some of the identified factors.

SECOND BRAZILIAN CONSENSUS ON THE MANAGEMENT OF ULCERATIVE COLITIS IN ADULTS: A CONSENSUS OF THE BRAZILIAN ORGANIZATION FOR CROHN'S DISEASE AND COLITIS (GEDIIB).

BACKGROUND: Inflammatory bowel diseases are immune-mediated disorders that include Crohn's disease (CD) and ulcerative colitis (UC). UC is a progressive disease that affects the colorectal mucosa causing debilitating symptoms leading to high morbidity and work disability. As a consequence of chronic colonic inflammation, UC is also associated with an increased risk of colorectal cancer. OBJECTIVE: This consensus aims to provide guidance on the most effective medical management of adult patients with UC. METHODS: A consensus statement was developed by stakeholders representing Brazilian gastroenterologists and colorectal surgeons (Brazilian Organization for Crohn's Disease and Colitis [GEDIIB]). A systematic review including the most recent evidence was conducted to support the recommendations and statements. All recommendations/statements were endorsed using a modified Delphi Panel by the stakeholders/experts in inflammatory bowel disease with at least 80% or greater consensus. RESULTS AND CONCLUSION: The medical recommendations (pharmacological and non-pharmacological) were mapped according to the stage of treatment and severity of the disease onto three domains: management and treatment (drug and surgical interventions), criteria for evaluating the effectiveness of medical treatment, and follow-up/patient monitoring after initial treatment. The consensus targeted general practitioners, gastroenterologists and surgeons who manage patients with UC, and supports decision-making processes by health insurance companies, regulatory agencies, health institutional leaders, and administrators.