BACKGROUND & AIMS: A better understanding of prognostic factors in ulcerative colitis (UC) could improve patient management and reduce complications. We aimed to identify evidence-based predictors for outcomes in pediatric UC, which may be used to optimize treatment algorithms. METHODS: Potential outcomes worthy of prediction in UC were determined by surveying 202 experts in pediatric UC. A systematic review of the literature, with selected meta-analysis, was performed to identify studies that investigated predictors for these outcomes. Multiple national and international meetings were held to reach consensus on evidencebased statements. RESULTS: Consensus was reached on 31 statements regarding predictors of colectomy, acute severe colitis (ASC), chronically active pediatric UC, cancer and mortality. At diagnosis, disease extent (6 studies, N ¼ 627; P ¼ .035), Pediatric Ulcerative Colitis Activity Index score (4 studies, n ¼ 318; P < .001), hemoglobin, hematocrit, and albumin may predict colectomy. In addition, family history of UC (2 studies, n ¼ 557; P ¼ .0004), extraintestinal manifestations (4 studies, n ¼ 526; P ¼ .048), and disease extension over time may predict colectomy, whereas primary sclerosing cholangitis (PSC) may be protective. Acute severe colitis may be predicted by disease severity at onset and hypoalbuminemia. Higher Pediatric Ulcerative Colitis Activity Index score and C-reactive protein on days 3 and 5 of hospital admission predict failure of intravenous steroids. Risk factors for malignancy included concomitant diagnosis of primary sclerosing cholangitis, longstanding colitis (>10 years), male sex, and younger age at diagnosis. CONCLUSIONS: These evidence-based consensus statements offer predictions to be considered for a personalized medicine approach in treating pediatric UC.

Objectives: Use of thiopurines for inflammatory bowel diseases (IBDs) is declining in some parts of the world. We aimed to explore outcomes of thiopurines and predictors of response in a real-world prospective cohort of children with dose optimization. Methods: Children with IBD treated with thiopurines without biologics were enrolled. Dosing was guided by thiopurine S-methyltransferase-activity at baseline and by clinical response and toxicity at 4 months; 1 year into the study, therapeutic drug monitoring at 4 months was also considered in the decision making. The primary outcome was steroid-free remission without treatment escalation by 12 months (SFR), using the intention-to-treat approach. Results: A total of 129 children were included (74% Crohn disease [CD] and 26% ulcerative colitis [UC]). SFR was achieved in 37 (39%) CD and 13 (39%) UC patients, and SFR with normal erythrocyte sedimentation rate/C-reactive protein in 20 (21%) and 9 (27%), respectively. At 4 months, mean corpuscular volume/white blood cell ratio and Δ absolute neutrophil count weakly correlated with 6-thioguanine (r = 0.33, P = 0.02 and r = 0.32, P = 0.02, respectively). In CD, SFR was associated with 4-month median weighted Pediatric Crohn Disease Activity Index (2.5 [IQR 0–7.5] in responders vs 5 in nonresponders [0–12.5], P = 0.048) and Δabsolute neutrophil count (1.7 [IQR 0.7–4.1] vs 0.05 [−2.3–0.9]; P = 0.03). Mild drug-related adverse events were recorded in 30 children (22%), 3 required stopping the drug. Conclusions: In this real-life prospective cohort using dose optimization, thiopurines were safe and effective in 21% of CD and 27% of UC patients, including normalization of C-reactive protein and erythrocyte sedimentation rate. Thiopurines remain a viable option in the treatment algorithm of mild-moderate pediatric IBD, especially in girls whose risk for lymphoma is lower.

Background The term “nocebo effect” describes the phenomenon that the mere knowledge and anticipation of possible negative consequences of an intervention can increase the probability of experiencing these consequences. Our objective was to assess whether different information presentations on adverse events (AEs) in package information leaflets (PILs) could influence the nocebo effect. Methods We included patients undergoing orthopaedic surgery in this pilot randomised controlled trial (pRCT). Patients were assigned by random, computerised and centralised allocation to one of three groups: Simplified-PIL, No-PIL or Standard-PIL on ibuprofen. The Simplified-PIL was written in plain language, and AEs were reported with a focus on avoiding biased risk perception. Only the outcome assessment was blinded. Results We included 35, 33 and 34 patients in the Simplified-PIL, No-PIL and Standard-PIL groups, respectively. All patients were included in the intention-to-treat analysis. Six patients in the Simplified-PIL, four in the No-PIL and eight in the Standard-PIL group reported an AE. This corresponds to relative risks of 0.80 (95% confidence interval (CI) 0.27–1.90) for the Simplified-PIL and 0.50 (95% CI 0.14–1.46) for the No-PIL compared with the Standard-PIL group. The Simplified-PIL increased knowledge, reduced anxiety and improved adherence, although statistical uncertainty was high for all of these outcomes. Conclusions This pRCT provides the first hints on the way information on AEs is reported in PILs can affect the nocebo effect. This pRCT shows that a definitive RCT is feasible. If the results are confirmed in a definitive large RCT, a revision of the current practice for designing PILs should be considered. Trial registration ClinicalTrials.gov identifier: NCT03428035 . Registered 2 February 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3565-3) contains supplementary material, which is available to authorized users.

Objectives: There is a lack of evidence-based consensus for the utility of gastrointestinal endoscopy (GIE) in an array of frequently occurring symptoms in children. We aimed to assess the diagnostic yield of endoscopy in an effort to aid clinical decision making.Methods: Retrospective analysis included patients ≤18 years who underwent GIE during one calendar year at Shaare Zedek Medical Center. We excluded children referred for predefined obvious indications for GIE, planned follow-up procedures, and therapeutic endoscopy. Clinician-assigned indication for endoscopy as well as endoscopic and histologic findings were recorded. Diagnostic yield of GIE was determined according to referral indication.Results: There were 794 endoscopies performed of which 329 were included in the analysis (mean age 9.3 ± 5.0 years, 51% female). No significant complications of GIE were recorded. Six major referral indications were identified among which abdominal pain was the most frequent 88/329 (26%) of whom 32/88 (36%) had a significant diagnostic finding. Among the other major indications, diagnostic findings were found in 36/85 (43%) children with primary indication of chronic diarrhea, 14/33 (42%) failure to thrive, 15/32 (46%) short stature, 30/56 (54%) iron deficiency, and 20/48 (42%) weight loss.Conclusions: Pediatric GIE is a safe procedure with diverse clinical indications. The diagnostic yield of endoscopy is variable, depending on the referral indication. These data can assist formulating judicious referral practices.

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