Selecting first-line advanced therapy for ulcerative colitis: A clinical application of personalized medicine.

Ulcerative colitis (UC) is a chronic autoimmune inflammatory disease that affects the colon, leading to symptoms of bloody diarrhea, abdominal cramps, and urgency. The treatment of UC has evolved over the past few decades from locally active anti-inflammatory compounds to more selective therapies that target specific arrays of the immune system. The challenge of selecting the first advanced therapy became apparent in this rapidly expanding landscape of medications. No current investigational tools, such as genetic, immunologic, or biological markers, can guide the identification of the safest and most effective therapeutic option for each patient. Hence, physicians must carefully assess patient/disease characteristics and match them with the most suitable drug through a clinically driven assessment. In this paper, we outline patient and drug characteristics that play a role in selecting first-line advanced therapies for UC and propose an algorithm for selection.

Saudi consensus guidance for the management of inflammatory bowel disease during pregnancy.

ABSTRACT: The management of inflammatory bowel disease (IBD) in pregnant women is challenging and must be addressed on a patient-by-patient basis. Optimal patient management requires a multidisciplinary team and clear evidence-based recommendations that cater to this subset of patients. In this article, we provide concise guidelines and clinical care pathway for the management of IBD in pregnant women. Our recommendations were developed by a multidisciplinary working group that includes experts from the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacology. All recommendations are based on up-to-date information following an extensive literature review. A total of 23 evidence-based expert opinion recommendations for the management of IBD in pregnant women are herein provided.

The prevalence and risk factors for hiatal hernia among patients undergoing endoscopy: A retrospective analysis.

OBJECTIVES: To determine the prevalence of hiatal hernia (HH) and its association with age, gender, and body mass index (BMI). METHODS: We retrospectively included patients who underwent esophagogastroduodenoscopy (EGD) at an academic tertiary care hospital. Data were collected on the presence of HH as well as patient demographics including age, gender, and BMI. Univariate and multivariate analysis were done to determine risk factors for HH. RESULTS: A total of 2805 patients were included in this study. The mean age was 48.6 (±18.6) years and males constituted 28.8% of the study population. The mean BMI was 29.7 (±8.6) kg/m². The prevalence of HH was 29.8% among all patients and 48.6% among those who underwent EGD for gastroesophageal reflux disease-related indications. There was no significant association between HH and female gender (OR 1.04, 95%CI: 0.88 -1.26, p=0.53), older age (OR 0.77, 95%CI: 0.72 - 1.06, p=0.19) or BMI (OR 1.07, 95%CI: 0.9 - 1.2, p=0.39). CONCLUSION: The prevalence of HH was 28.9% based on this large endoscopy-based population. We found no association between HH and gender, age, or BMI.

Inflammatory bowel disease in the elderly: A focus on disease characteristics and treatment patterns.

Background: As the population ages, the number of elderly inflammatory bowel disease (IBD) patients is expected to increase. The clinical features and therapeutic options for young and old patients may differ, as elderly IBD patients are likely to have different comorbidities and disease characteristics. The goal of this study was to examine the clinical aspects and therapeutic choices for elderly Saudi IBD patients. Methods: We conducted a retrospective study aimed at describing the demographic, clinical, and management characteristics of IBD in elderly patients (≥60 years) who followed up at King Abdulaziz University Hospital (KAUH), Jeddah, Saudi Arabia. The data was extracted from the KAUH inflammatory bowel disease information system (IBDIS) registry. The primary outcome was to describe disease characteristics in accordance with the Montréal classification and the secondary outcomes were to describe treatment patterns and identify significant clinical associations. Results: Our data were collected from 76 patients who fulfilled the study inclusion criteria. Females outnumbered males (53.9% vs 46.1%) and the mean age was 51.5 ± 9.7 years. Essential hypertension (26.3%) was the most common comorbidity followed by diabetes mellitus (23.6%), and malignant neoplasms (9.21%). More than half of the patients with Crohn's disease (CD) had disease onset after forty years of age. The most common form of disease distribution was ileocolonic disease (64.7%). Less than 17% of patients had a penetrating disease phenotype. About 88 percent of patients with UC presented >40 years of age. Approximately, half of the cohort had left-sided ulcerative colitis (UC) (48%), followed by pancolitis (40%). The most prescribed medication class for IBD was 5-aminosalicylic acid (5-ASA) derivatives (56.58%) followed by corticosteroids and immunosuppressive drugs. Conclusions: In Saudi Arabia, age-specific concerns including comorbidities and polypharmacy remain the major challenges in the management of elderly IBD patients.

Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program.

BACKGROUND: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The tofacitinib OCTAVE clinical program included phase III induction (OCTAVE Induction 1 and 2) and maintenance (OCTAVE Sustain) studies, and an open-label, long-term extension study (OCTAVE Open). OBJECTIVE: This post hoc analysis assessed selected long-term, disease-specific patient-reported outcome (PRO) and health-related quality-of-life (HRQoL) measurements in patients with UC receiving tofacitinib in the OCTAVE clinical program. METHODS: Analyses included patients from OCTAVE Open assigned to tofacitinib 5 mg twice daily (subpopulation in remission at Week 52 of OCTAVE Sustain). OCTAVE Open data from the final analyses are shown to Month 48. Endpoints included rectal bleeding subscore (RBS) = 0, stool frequency subscore (SFS) ≤ 1, and HRQoL measure, Inflammatory Bowel Disease Questionnaire (IBDQ) remission (IBDQ total score ≥ 170); with non-responder imputation for missing data at all visits, and last observation carried forward for visits after a patient advanced to the next study (NRI-LOCF). Observed cases were also assessed. RESULTS: At Month 48, of 175 patients, 95 (54.3%) and 96 (54.9%) achieved/maintained RBS = 0 and SFS ≤ 1, respectively (NRI-LOCF). Additionally, 93 (53.1%) patients achieved/maintained IBDQ remission at Month 48 (NRI-LOCF). CONCLUSIONS: Among patients who entered OCTAVE Open in remission, most maintained normalization of rectal bleeding and improvement in stool frequency for ≤ 4 years of follow-up in OCTAVE Open. IBDQ remission was also generally maintained in OCTAVE Open. These data show robust maintenance of key UC PROs and durability of response with tofacitinib 5 mg twice daily. TRIAL REGISTRATION: http://www. CLINICALTRIALS: gov (NCT01465763 [21/10/2011]; NCT01458951 [21/10/2011]; NCT01458574 [21/10/2011]; NCT01470612 [21/10/2011]).

Multimorbidity among inflammatory bowel disease patients in a tertiary care center: a retrospective study.

BACKGROUND AND OBJECTIVES: Inflammatory bowel disease (IBD) is a chronic systemic inflammatory condition that debilitate the quality of life. Multimorbidity, a concept only beginning to emerge in IBD, is defined as two or more comorbidities present in the same individual. Notably, we used the term multimorbidity to refer to two or more comorbidities excluding IBD. Multimorbidity is linked to decreased quality of life, poorer disease outcomes, increased hospitalizations, healthcare costs and polypharmacy complications. We aim to estimate the prevalence of multimorbidity and to explore its effect on IBD patients. METHODS: We retrospectively reviewed all IBD patients registered in a validated web-based registry since February 2018. Data on patient demographics, comorbidities, IBD and extraintestinal complications were obtained. We analyzed the date using univariate, bivariate and multivariable analysis. RESULTS: Among 767 IBD patients, 54.6% had Crohn's disease (CD), 41.9% had ulcerative colitis (UC) and 3.5% had IBD unclassified. The median age at diagnosis was 22 years (IQR: 15-29). Males compromised 50.2% of patients. According to the Montréal IBD classification, most UC patients had moderate UC (47.8%) while most CD patients had non-stricturing non-penetrating CD (49.8%). Overall, 10.3% IBD patients had multimorbidity and 23.9% had at least one comorbidity. The most common comorbidity was diabetes mellitus (4.9%) followed by essential hypertension (4%) and iron deficiency anemia (3%). Female gender (P = 0.008) and UC (P = 0.005) were more likely to have multimorbidity. Multimorbid IBD patients were more likely to develop thrombosis than non-multimorbid peers (16.7% vs. 1.6%; P < 0.001). Higher age at diagnosis (OR = 1.04, 95%CI: 1.01-1.07) and having a history of thrombosis (OR = 7.82, 95% CI: 2.67-22.92) are associated with increased risk of multimorbidity. CONCLUSION: Multimorbidity is not uncommon among IBD patients, especially females diagnosed with UC. Our findings indicate that future studies are needed to explore the effects of multimorbidity on IBD patients.

Saudi Arabia consensus guidance for the diagnosis and management of adults with inflammatory bowel disease.

Optimal management of inflammatory bowel disease (IBD) relies on a clear understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This article provides concise guidelines for the management of IBD in adults, based on the most up-to-date information at the time of writing and will be regularly updated. These guidelines were developed by the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacy. After an extensive literature review, 78 evidence-and expert opinion-based recommendations for diagnosing and treating ulcerative colitis and Crohn's disease in adults were proposed and further refined by a voting process. The consensus guidelines include the finally agreed on statements with their level of evidence covering different aspects of IBD diagnosis and treatment.

Human papillomavirus bowel colonization in inflammatory bowel disease: A comparative case control study.

Background and Aims: Although much of the research on the plausible environmental triggers for inflammatory bowel disease (IBD) has focused on bacterial pathogens, the relationship between bowel colonization with human papillomavirus (HPV) and IBD has not been previously explored. In this study, we aimed to investigate the association between HPV ileocolonic colonization and IBD. Patients and Methods: We performed a cross-sectional study involving consecutive patients with established IBD who were referred for endoscopic evaluation. During endoscopy, mucosal biopsies were obtained from the most inflamed colonic or ileal segments in cases and from the rectosigmoid region for controls. A hybrid capture assay was used to detect tissue HPV. The prevalence of HPV colonization was determined for cases and controls and was compared using Fisher's exact test. Results: A total of 201 patients, including 104 patients with IBD and 97 non-IBD controls, were prospectively included. Females comprised 55.5% of the study participants (58% vs. 55.2% for controls, P = 0.94). Fifty-seven (54.8%) patients had ulcerative colitis, and 45 (43.2%) had Crohn's disease. The mean age was 43.2 +-18.2 years. Endoscopically active disease was documented in 56 cases (56%). HPV colonization was detected in four (4.1% subjects in controls vs. none in the cases, P = 0.05). Conclusions: There was no evidence of HPV ileocolonic colonization in this cohort of patients with IBD, regardless of disease activity. HPV colonization does not appear to be linked to IBD diagnosis or disease severity.

Factors Affecting Ulcerative Colitis Flare-Ups: Associations With Smoking Habits and Other Patient Characteristics.

Background and study aims Currently, there are no studies conducted in the Kingdom of Saudi Arabia (KSA) that have assessed the relationship between ulcerative colitis (UC) flare-ups and smoking. The present study aims to assess the risk of UC flare-ups and evaluate the relationship between UC flare-ups and smoking in adult patients following up at King Abdulaziz University Hospital in Jeddah, KSA. Patients and methods This was a retrospective study involving patients with confirmed UC between January 2015 and December 2020. Various information was examined, including demographic, clinical, endoscopic, radiologic, and laboratory data. Descriptive statistics were used for summarizing findings and a logistic regression analysis was applied to test for possible associations. Results Eighty-nine patients with UC were included in the study. Almost half (48.3%) had recurrent UC flare-ups during follow-up. A non-significant relationship was found between recurrent UC flares and all types of smoking habits (cigarette smoking, P = 0.15; shisha smoking, P = 0.88; and vape smoking, P = 0.09). Participants who were underweight (P = 0.041), had family history of UC (P = 0.013), depression (P = 0.033), fecal incontinence (P = 0.003), iron deficiency anemia (P = 0.009), or a malignancy (P = 0.039) had a significantly higher probability of experiencing recurrent flares. Binary logistic regressions revealed that family history of UC (OR = 5.3, P = 0.007) and fecal incontinence (OR = 4.7, P = 0.006) were associated significantly with recurrent flares. Conclusion There was no clear association between smoking and recurrent UC flares identified in this cohort. Of the variables considered, UC patients with fecal incontinence or family history of UC were at the highest risk of developing recurrent flares.

Work and School Absenteeism in Inflammatory Bowel Disease Patients in Jeddah, Saudi Arabia: A Cross-Sectional Study.

BACKGROUND: Inflammatory bowel disease (IBD), which can have a considerable effect on quality of life, productivity and performance, is typically diagnosed during periods of life in which patients have academic and career-related responsibilities. OBJECTIVE: The objective of the study was to determine the effect of IBD symptoms on work and school absenteeism in patients from Saudi Arabia. PATIENTS AND METHODS: This cross-sectional survey included patients diagnosed with IBD, aged >8-60 years, at King Abdulaziz University Hospital, Jeddah, Saudi Arabia. The validated 32-question IBD quality-of-life questionnaire was used to elicit information regarding quality of life and another 9-question validated questionnaire was used to assess work and school absenteeism. A logistic regression analysis was used to identify possible determinants of absenteeism. RESULTS: A total of 123 IBD patients were included, with a 1:1 male-to-female ratio. The median age at presentation was 26 years (range: 8-59 years), 56.9% had Crohn's disease, and 43.1% had ulcerative colitis. Further, 58 (47.2%) were employed, 49 (39.8%) were students and 16 (13%) were unemployed. Forty-seven (43.9%) participants reported absenteeism: 26 were employees (55.3%) and 21 were students (44.7%). A binary logistic regression analysis identified IBD subtype (P = 0.006) and the presence of perianal disease (P = 0.028) as clinical predictors for absenteeism from school or work. A feeling of abdominal pain (P = 0.015), fatigue (P = 0.015) and difficulty taking part in social engagements (P < 0.001) were also significantly associated with absenteeism. CONCLUSIONS: A sizeable proportion of the participants reported absenteeism owing to the effects of IBD. IBD subtype, perianal disease, presence of ongoing abdominal pain, fatigue and difficulty in social engagement were strongly associated with nonattendance.

Solitary rectal ulcer syndrome in children and adolescents: a descriptive clinicopathologic study.

Solitary rectal ulcer syndrome (SRUS) is an uncommon disorder of the rectum. While benign, it can cause concern for patients and affect quality of life. Reported studies on SRUS worldwide are scarce. The aim of this study is to describe the clinicopathologic characteristics of SRUS in a cohort of children based in Saudi Arabia. In this study, children with a confirmed diagnosis of SRUS at King Abdulaziz University Hospital (KAUH) were included, during the period November 2003 to November 2017. Data were collected from hospital medical records. The study comprised twenty-one patients: 17 males (81%) and 4 females (19%); the median age was 11.4 years (range, 5.43-17.9 years). The most common presenting symptoms were rectal bleeding in 21 patients (100%), passage of mucus in 16 (76.1%), abdominal pain in 14 (66.6%), constipation in 13 (61.9%), straining in 9 (42.9%), and rectal prolapse in 5 (23.8%). The most common finding at initial colonoscopy was a single ulcer in 7 patients (33.3%), multiple ulcers in 6 (28.5%), polypoid lesions in 5 (23.8%), and hyperemic mucosa in 3 (14.2%). All patients received medical treatment and 14 (81%) continued to manifest one or more of the symptoms following treatment, which required subsequent modification of the treatment course. None of the patients required surgery. In conclusion, the study found rectal bleeding to be the most common presentation, with a single ulcer being the most prevalent lesion in endoscopy. Treatment response was variable, but almost half of patients reported relief of symptoms following treatment.

Clinical characteristics, natural history, and outcomes of Crohn's-related intra-abdominal collections.

BACKGROUND: Intra-abdominal collections in the form of abscesses or matted bowel loops, called phlegmons, might occur in patients with Crohn's disease (CD). The clinical characteristics and management of such conditions are not well described. We aim to characterize CD-related intra-abdominal collections clinically, and identify predictors of need for surgical interventions and the time to surgery. METHODS: We utilized the Saudi Inflammatory Bowel Disease Information System (IBDIS) database to identify all patients treated for radiologically proven intra-abdominal abscesses or phlegmons since inception. Demographics, clinical data, clinical course, and treatment outcomes were recorded. Logistic regression analysis and survival analysis were used to identify predictors of surgical resection and differences in time to surgery between patient subgroups, respectively. RESULTS: A total of 734 patients with a diagnosis of CD were screened and 75 patients were identified. The mean age was 25.6 ± 9.9 years and 51% were males. Nearly 60% of patients had abscesses larger than 3 cm while 13% had smaller abscesses and 36% had phlegmons. On presentation, the most commonly reported symptom was abdominal pain (99%) followed by weight loss (27%). About 89% of patients were treated with antibiotics during hospitalization for an average of 2.7 weeks. Steroids were prescribed for 52% of patients and tumor necrosis factor alpha (TNF-alpha) antagonists for 17%. Surgical resection was required for 33 patients (44% of the cohort) while 51% were managed with antibiotics and/or percutaneous drainage. The most common surgical intervention was ileocecal resection (45%). Although patients who underwent follow-up imaging were more likely to require early surgical intervention (P = 0.04), no statistically significant predictor of surgery could be identified from this cohort. Time to surgery varied numerically according to abscess size (HR = 1.18, 95% CI = 0.62-2.27, P = 0.61). CONCLUSIONS: Although the majority of patients with CD-related intra-abdominal collections underwent surgical resection in this cohort, no obvious predictors of surgical intervention could be identified. The decision to perform early surgery appeared to be influenced by the findings observed on cross-sectional imaging during the follow-up of these collections.

Prevalence and Predictors of Reduced Bone Density in Child and Adolescent Patients With Crohn's Disease.

Reduced bone mineral density (BMD) has broadly been found to be associated with inflammatory bowel disease across a number of geographical locations and cultures. We aimed to estimate the prevalence of reduced BMD and identify clinical predictors in a cohort of Crohn's disease patients (CD) in Saudi Arabia. We conducted a retrospective study involving children and adolescents with CD between 2013 and 2018. BMD was evaluated using dual-energy X-ray absorptiometry scans of the spine and body. A multivariate analysis was performed for the detection of predictors of low BMD. Sixty-four patients were enrolled. The median age was 16 years (range, 8-19 years) and 55% of patients were males. Total body BMD scanning identified 25 patients (39%) with osteoporosis. Twenty patients (31.3%) were found to have z scores consistent with osteopenia. A multivariate regression analysis identified a low weight-for-age z score (B coefficient = 0.347, 95% confidence interval [CI] = 0.211-0.482, p < 0.001 for Spine BMD and B coefficient = 0.321, 95% CI = 0.170-0.472, p < 0.001 for total body BMD), a low height-for-age z score (B coefficient = 0.187, 95% CI = 0.035-0.338, p = 0.017 for spine BMD and B coefficient = 0.0.258, 95% CI = 0.089-0.427, p = 0.004 for total body BMD), a low 25-hyroxyvitamin D level (B coefficient = 0.026, 95% CI = 0.013-0.038, p < 0.001 for spine BMD and B coefficient = 0.016, 95% CI = 0.002-0.031, p = 0.026 for total body BMD), and a higher number of corticosteroid induction courses (B coefficient = -0.567, 95% CI = -0.923 to -0.212, p = 0.003 for spine BMD and B coefficient = -0.566, 95% CI = 0.963-0.169, p = 0.007 for total body BMD) as predictors of low BMD. In the spine BMD analysis, older age at the time of presentation was identified as a significant predictor for low bone density (B coefficient = 0.254, 95% CI = 0.141-0.368, p < 0.001). In conclusion, Saudi Arabian children and adolescents with CD have a high prevalence rate of low bone density compared to Western populations. Several clinical characteristics are identified as significant predictors for low BMD.

Inflammatory bowel disease and restless leg syndrome.

OBJECTIVE: Inflammatory bowel disease (IBD) has been associated with restless leg syndrome (RLS). This study aims to explore the prevalence, clinical predictors, and severity of RLS in IBD patients compared to controls. METHODS: We conducted a case-control study between January and December of 2019 comparing IBD patients with controls. Assessment of RLS was performed using the previously validated diagnostic restless leg syndrome questionnaire (RLSQ). Logistic regression analyses were applied to investigate associations between patient demographics and clinical features and RLS diagnosis. RESULTS: A total of 218 IBD patients and 211 healthy controls were incorporated after excluding 6 patients with positional discomfort and 4 patients with habitual foot tapping. The mean age was 30.2+/-11.7 and 64% were females. The prevalence of RLS was 16/218 (7.34%) and 17/211 (8.06%) among cases and controls, respectively. Based on the RLSQ severity score, 6/16 (37.5%), 4/16 (25%) and 1/16 (6.3%) of the IBD patients with RLS had mild, moderate and severe RLS; respectively. The odds of IBD were lower among patients with confirmed RLS (OR=0.90, 95% CI=0.44-1.84, p=0.78). In the logistic regression analysis, only vitamin B12 deficiency (OR=10.20, 95% CI=1.40-74.10, p=0.022) was associated with RLS diagnosis among IBD patients. CONCLUSION: No difference was found in the prevalence of RLS between IBD patients and non-IBD controls. Vitamin B12 deficiency was associated with RLS diagnosis among patients with IBD.

The Impact of the Pharmaceutical Care Management Model of Hepatitis C Medications on the Cost at Health Insurance Level.

OBJECTIVE: The aim of this study is to evaluate the impact of adopting a pharmaceutical care model on clinical outcomes, patient satisfaction, and cost at a health payer level. METHODS: All patients with hepatitis C virus (HCV) who were insured by Bupa Arabia, with a direct-acting antivirals prior authorization drug request between April 2015 and October 2018 were included in this retrospective quasi-experimental study. The clinical outcome was the achievement of a sustained virologic response at least 12 weeks from end of treatment. Economic and patients' satisfaction outcomes were included in this study. The differences in cost of treatment was analyzed by using the paired t test. Stata statistical software package (StataCorp, College Station, TX) was used for data analysis. RESULTS: A total of 371 patients were enrolled in this program of which 74% (n = 273) required clinical intervention. Among those, HCV treatment was modified for 64%. The overall cure rate was 97% among 267 patients for which sustained virologic responses were available. The results of the paired t test show that there was a 38% reduction in the mean direct cost of medications before and after intervention (95% confidence interval, 33%-43%; P<.001) and the calculated patients' satisfaction was 98%. CONCLUSIONS: A structured pharmaceutical care program for HCV patients can guide the use of specialty medications to achieve optimal clinical outcomes, with lower expenditures and high patients' satisfaction. We can conclude that healthcare insurance can play a key role in managing specialty pharmaceuticals like HCV medications. Because this is a preliminary study, further studies are needed in an experimental design to strengthen the evidence behind the effectiveness of such a program.

Adherence to the Saudi dietary guidelines and its relation to colorectal polyps: A university hospital-based study.

OBJECTIVES: Colorectal polyps are a known precursor to colorectal cancer (CRC). Using the Saudi dietary guidelines adherence scores, this study evaluated whether dietary intake can lead to the development of colorectal polyps in a Saudi cohort. METHODS: In a cross-sectional study, 101 patients of both sexes, aged 30-86 years (40 patients with colorectal polyps and 61 patients without polyps), were recruited from the endoscopy unit in a Saudi hospital. A questionnaire was administered to collect demographic data, anthropometric data, and information about dietary habits. RESULTS: Patients with colorectal polyps were significantly older than those without polyps (p = 0.05). The mean body mass index in both patient groups was within the overweight range, with a value of 28.6 ± 6.7 kg/m2. We did not find significant differences between patients with and without colorectal polyps. Although there was no difference in the overall scores for adherence to the Saudi dietary guidelines between the two groups, the specific adherence score for vegetables was significantly higher in patients without colorectal polyps (5.0 ± 0.0 vs. 4.9 ± 0.3, p = 0.03). CONCLUSION: Ageing and lower vegetable intake, previously reported to be risk factors for CRC, were likewise identified in this study. However, a multi-centre study with a larger sample size, utilising data from this study, is needed.

Awareness of the first aid management of foreign body aspiration among students: A cross-sectional study.

BACKGROUND: Pediatric foreign body aspiration (FBA) is a life-threatening condition responsible for many deaths every year, especially among children younger than 2 years. OBJECTIVE: This study aimed to determine the level of knowledge among students in Jeddah, Saudi Arabia. SUBJECTS AND METHODS: This observational, cross-sectional study was conducted between December and January 2018 at Jeddah, Saudi Arabia via a paper-based questionnaire survey of male and female high school and middle school students. The Chi-square test was used to compare frequencies, and the independent t-test was used to compare means. RESULTS: A total of 671 students participated in this survey. The second item, "It is possible for a child to choke on a small toy" had the highest rate of correct responses among both males and females (93.2% vs. 94%, respectively). The eighth item "Sudden cough is a sign of choking among children" had the lowest rate of correct responses among males (40.8%) and females (33%). Most female participants (74.2%) knew that batteries are the most dangerous items a child can swallow, which requires immediate medical attention (item 14), while only 56.2% of male participants knew that (P < 0.001). The only significant predictor on linear regression analysis was "Having treated anyone with FBA" (coefficient = -0.24, P = 0.03). CONCLUSIONS: There is inadequate knowledge regarding FBA among middle and high school students, as is the case among mothers. Moreover, only a small percentage of participants had any first aid training.

Arabic translation and psychometric testing of the self-screening malnutrition universal screening tool in inflammatory bowel disease patients.

OBJECTIVES: To translate and validate the malnutrition universal screening tool (MUST) for use in Arabic-speaking outpatients with inflammatory bowel disease (IBD). METHODS: We translated the MUST into Arabic by using the Brislin back-translation method. This methodological study was performed between August 2016 and November 2017 on 143 outpatients with IBD at King Abdulaziz University Hospital, Jeddah, Saudi Arabia. The patients must completed the self-administered (PSA) Arabic version of the MUST. Then, the health-care practitioners (HCPs) administered the Arabic MUST and performed standard patient clinical assessment. The nutrition risk was defined as low (MUST score=0), medium (MUST score=1), or high (MUST score greater than 1). The chance-corrected proportional agreement between the scores from the PSA and HCP-administered Arabic MUST was evaluated using Cohen's kappa coefficient. Internal consistency was evaluated using Cronbach's alpha statistic. RESULTS: The overall agreement between the PSA and HCP-administered Arabic MUST was almost perfect (agreement=95.9%, expected agreement=72.4%, kappa=0.85, p less than 0.0001). The calculated Cronbach's alpha statistic for MUST scores in 15/143 (10%) patients was 0.79. The calculated Pearson's correlation coefficient between PSA and HCP-administered MUST scores was 0.93 (p less than 0.0001). CONCLUSIONS: The PSA and HCP-administered Arabic MUST showed perfect agreement in outpatients with IBD.

Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis.

BACKGROUND AND AIMS: Pouchitis is a common adverse event after proctocolectomy with ileal pouch anal anastomosis for ulcerative colitis. Evaluation of pouchitis disease activity and response to treatment requires use of validated indices. We assessed the reliability of items evaluating endoscopic pouchitis disease activity. METHODS: Twelve panelists used a modified RAND appropriateness methodology to rate the appropriateness of items evaluating endoscopic pouchitis disease activity derived from a systematic review and also identified additional potential endoscopic items based on expert opinion. Four central readers then evaluated 50 pouchoscopy videos in triplicate, in random order. Intra- and inter-rater reliability for each item was assessed by calculating and comparing intraclass correlation coefficients (ICCs). A Delphi process identified common sources of disagreement among the readers. RESULTS: Ten existing endoscopic items were identified from the systematic review and an additional 7 exploratory items from the panelists. ICCs for inter-rater reliability were highest for the existing item of pouch ulceration (.72; 95% confidence interval [CI], .60-.82) and for the exploratory item of ulcerated surface in the pouch body (.67; 95% CI, .53-.75). Inter-rater reliability for all other existing and exploratory items was "moderate" (ICC < .60). The item "ulcerated surface in the pouch body" demonstrated the best correlation with a global evaluation of lesion severity (r = .80; 95% CI, .73-.85). CONCLUSION: Substantial reliability was observed only for the endoscopic items of ulceration and ulcerated surface in the pouch body. Future studies should assess responsiveness to treatment in the next stage toward development of an endoscopic pouchitis disease activity index.

Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis.

BACKGROUND: Endoscopic assessment of mucosal disease activity is routinely used to determine eligibility and response to therapy in clinical trials of ulcerative colitis. The operating properties of the existing endoscopic scoring indices are unclear. OBJECTIVES: A systematic review was undertaken to evaluate the development and operating characteristics of endoscopic scoring indices for the evaluation of ulcerative colitis. SEARCH METHODS: We searched MEDLINE, Embase and CENTRAL from inception to 5 July 2016. We also searched references and conference proceedings (Digestive Disease Week, United European Gastroenterology Week, European Crohn's and Colitis Organization). SELECTION CRITERIA: Any study design (e.g. randomized controlled trials, cohort studies, case series) that evaluated endoscopic indices for evaluation of ulcerative colitis disease activity were considered for inclusion. Eligible participants were adult patients (> 16 years), diagnosed with ulcerative colitis using conventional clinical, radiologic and endoscopic criteria. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed the studies identified from the literature search. These authors also independently extracted and recorded data on the number of patients enrolled; number of patients per treatment arm; patient characteristics including age and gender distribution; endoscopic index; and outcomes such as reliability (intra-rater and inter-rater), validity (content, construct, criterion), responsiveness and feasibility. Any disagreements regarding study inclusion or data extraction were resolved by discussion and consensus with a third author. Risk of bias was assessed by determining whether assessors were blinded to clinical information and whether assessors scored the endoscopic index independently. We also assessed the methodological quality of the validation studies using the COSMIN checklist MAIN RESULTS: A total of 23 reports of 20 studies met the pre-defined inclusion criteria and were included in the review. Of the 20 included validation studies, 19 endoscopic scoring indices were assessed, including the Azzolini Classification, Baron Score, Blackstone Endoscopic Interpretation, Chinese Grading System of Ulcerative Colitis, Endoscopic Activty Index, Jeroen Score, Magnifying Colonoscopy Grade, Matts Score, Mayo Clinic Endoscopic Subscore, Modified Baron Score, Modified Mayo Clinic Endoscopic Subscore, Osada Score, Rachmilewtiz Endoscopic Score, St. Mark's Index, Ulcerative Colitis Colonoscopic Index of Serverity (UCCIS), endoscopic component of the Ulcerative Colitis Disease Activity Index (UCDAI), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), Witts Sigmoidoscopic Score and Watson Grade. The individuals who performed the endoscopic scoring were blinded to clinical and/or histologic information in ten of the included studies, not blinded to clinical and/or histologic information in one of the included studies, and it was unclear whether blinding occurred in the remaining nine included studies. Independent observation was confirmed in four of the included studies, unclear in five of the included studies, and non-applicable (since inter-rater reliability was not assessed) in the remaining eleven included studies. The methodological quality (COSMIN checklist) of most of the included studies was rated as 'good' or 'excellent'. One study that assessed responsiveness was rated as 'fair'. The inter-rater reliability of nine endoscopic scoring indices including the Baron Score, Blackstone Endoscopic Interpretation, Endoscopic Activity Index, Matts Score, Mayo Clinic Endoscopic Subscore, Osada Score, UCCIS, UCEIS, Watson Grade was assessed in seven studies, with estimates of correlation, ƙ, ranging from 0.44 to 0.97. The iIntra-rater reliability of seven endoscopic scoring indices including the Baron Score, Blackstone Endoscopic Interpretation, Matts Score, Mayo Clinic Endoscopic Subscore, Osada Score, UCCIS and UCEIS was assessed in three studies, with estimates of correlation, ƙ, ranging from 0.41 to 0.86. No studies assessed content validity. Three studies evaluated the criterion validity of three endoscopic scoring indices including the Rachmilewitz Endoscopic Score, Magnifying Colonoscopy Grade and the UCCIS. These indices were correlated with objective markers of disease activity including albumin, blood leukocytes, C-reactive protein, fecal calprotectin, hemoglobin, mucosal interleukin-8 concentration and platelet count. Correlation estimates ranged from r = -0.19 to 0.83. Thirteen endoscopic scoring indices were tested for construct validity in 13 studies. Estimates of correlation between the endoscopic scoring indices and other measures of disease activity ranged from r = 0.27 to 0.93. Two studies explored the responsiveness of four endoscopic scoring indices including the Mayo Endoscopic Subscore, Modified Baron Score, Modified Mayo Endoscopic Subscore and UCEIS. One study concluded that the Modified Baron Score, Modified Mayo Endoscopic Subscore and UCEIS had similar responsiveness for detecting disease change in ulcerative colitis. The other included study concluded that the UCEIS may be the most accurate endoscopic scoring tool. None of the included studies formally assessed feasibility. AUTHORS' CONCLUSIONS: While the UCEIS, UCCIS and Mayo Clinic Endoscopic Subscore have undergone extensive validation, none of these instruments have been fully validated and only two studies assessed responsiveness. Further research on the operating properties of these indices is needed given the lack of a fully-validated endoscopic scoring instrument for the evaluation of disease activity in ulcerative colitis.