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There is growing evidence that the incidence and severity of inflammatory bowel disease (IBD) may be geographically and seasonally related. Why these associations are observed remains unclear. We assessed the impact of geographic location, season, and exposure to ultraviolet light on disease severity by measuring national hospital IBD-related discharge rates. Utilizing the Nationwide Inpatient Sample (NIS), we identified all patients with IBD-related discharges from 2001-2007. Patients were included if they were discharged from states above the 40th parallel (north) or at or below the 35th parallel (south); and their discharge fell within the winter (January, February, and March) or summer (July, August, and September). Groups of patients were assessed comparing north to south within each season, and summer to winter within each region. UV index was recorded from the National Weather Service data and compared to monthly discharge rates. There was a consistent pattern of increased IBD-related hospitalization rates in northern states compared to southern states for both ulcerative colitis and Crohn's disease. Differences in IBD-related hospitalization rates by season, however, were not uniform across the years studied. UV index was significantly inversely associated although not proportional to discharge rates for both Crohn's disease and ulcerative colitis. In the US, there is a significant increased rate of IBD-related hospitalizations in the northern compared to southern states, which not fully explained by differences in UV exposure.

A small bowel source is suspected when evaluation of overt gastrointestinal (GI) bleeding with upper and lower endoscopy is negative. Video capsule endoscopy (VCE) is the recommended next diagnostic test for small bowel bleeding sources. However, clinical or endoscopic predictive factors for small bowel bleeding in the setting of an overt bleeding presentation are unknown. We aimed to define predictive factors for positive VCE among individuals presenting with overt bleeding and a suspected small bowel source. We included consecutive inpatient VCE performed between September 1, 2012 to September 1, 2015 for melena or hematochezia at two tertiary centers. All patients had EGD and colonoscopy performed prior to VCE. Patient demographics, medication use, and endoscopic findings were retrospectively recorded. VCE findings were graded based on the P0-P2 grading system. The primary outcome of interest was a positive (P2) VCE. The secondary outcome of interest was the performance of a therapeutic intervention. Data were analyzed with the Fisher exact test for dichotomous variables and logistic regression. Two hundred forty-three VCE were reviewed, and 117 were included in the final analysis. A positive VCE (P2) was identified in 35 (29.9%) cases. In univariate analysis, a positive VCE was inversely associated with presence of diverticula on preceding colonoscopy (OR: 0.44, 95% CI: 0.2-0.99), while identification of blood on terminal ileal examination was associated with a positive VCE (OR: 5.18, 95% CI: 1.51-17.76). In multivariate analysis, only blood identified on terminal ileal examination remained a significant risk factor for positive VCE (OR: 6.13, 95% CI: 1.57-23.81). Blood on terminal ileal examination was also predictive of therapeutic intervention in both univariate (OR: 4.46, 95% CI: 1.3-15.2) and multivariate analysis (OR: 5.04, 95% CI: 1.25-20.32). Among patients presenting with overt bleeding but negative upper and lower endoscopy, the presence of blood on examination of the terminal ileum is strongly associated with a small bowel bleeding source as well as with small bowel therapeutic intervention. Presence of diverticula on colonoscopy is inversely associated with a positive VCE and therapeutic intervention in univariate analysis.

Gastrointestinal (GI) sequelae, such as vomiting, hyperacidity, dysphagia, dysmotility, and diarrhea, are nearly universal among patients with nephropathic cystinosis. These complications result from disease processes (e.g., kidney disease, cystine crystal accumulation in the GI tract) and side effects of treatments (e.g., cysteamine, immunosuppressive therapy). GI involvement can negatively impact patient well-being and jeopardize disease outcomes by compromising drug absorption and patient adherence to the strict treatment regimen required to manage cystinosis. Given improved life expectancy due to advances in kidney transplantation and the transformative impact of cystine-depleting therapy, nephrologists are increasingly focused on addressing extra-renal complications and quality of life in patients with cystinosis. However, there is a lack of clinical data and guidance to inform GI-related monitoring, interventions, and referrals by nephrologists. Various publications have examined the prevalence and pathophysiology of selected GI complications in cystinosis, but none have summarized the full picture or provided guidance based on the literature and expert experience. We aim to comprehensively review GI sequelae associated with cystinosis and its treatments and to discuss approaches for monitoring and managing these complications, including the involvement of gastroenterology and other disciplines.

Hybridization can be an evolutionary creative force by forming new polyploid species, creating novel genetic variation or acting as conduits of potentially advantageous traits between hybridizing forms. Evidence for the latter is often difficult to find because alleles under positive selection can spread rapidly across a hybrid zone and sweep to fixation. In Western Panama, an avian hybrid zone between two species of manakins in the genus Manacus exists where the unidirectional introgression of bright, yellow plumage into a white population provides evidence for the importance of hybrid zones as conduits of advantageous traits. Several lines of indirect evidence suggest that sexual selection favoring yellow plumage drives this asymmetrical spread, but more direct evidence is lacking. Along the edge of the hybrid zone, both yellow- and white-collared manakins are found in the same mating arenas or leks and compete for the same females (“mixed leks”), providing us with a unique opportunity to understand the dynamics of yellow plumage introgression. We studied these mixed leks to determine whether yellow males have a mating advantage over white males and, if so, whether the mating advantage is driven by male-male interactions, female choice, or both. We found that yellow males mated more than white males, suggesting that sexual selection favoring yellow males can, indeed, explain the spread of yellow plumage. However, we found that this advantage occurred only in mixed leks where the frequency of yellow males is greater than white males. This suggests that the advantage of yellow males may depend on the presence of other yellow males, which may slow the rate of introgression in leks where yellow frequency is low such as in areas where yellow males are beginning to colonize the white population. This, along with the geographic barrier posed by major rivers in the hybrid zone, may initially limit or slow the spread of yellow plumage. Finally, we found that yellow and white males were similar in aggression and body size, and held comparable positions within leks. Because these traits or factors are often important in or dictated by aggressive male-male interactions, these comparisons indicate that male-male interaction is not the primary mechanism for the spread of yellow plumage. However, white and yellow males received similar numbers of courtship visits from females but differed in the number of matings, suggesting that females actively rejected white in favor of yellow males. Our results indicate that sexual selection by female choice has driven the unidirectional introgression of yellow plumage into the white population, providing a mechanism for how hybrid zones act as conduits of novel and advantageous traits.

The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling. In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m ) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m ). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss. At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group. The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.

Background and Objectives The safety of inflammatory bowel disease medications during lactation is of significant relevance to women of childbearing potential. Available data regarding the transfer of biologic agents for inflammatory bowel disease via breast milk are limited to case reports. The objective of this prospective postmarketing lactation study was to assess vedolizumab concentrations in breast milk from lactating vedolizumab-treated women with inflammatory bowel disease. Methods Breast milk was serially collected throughout the dosing interval from 11 patients receiving established intravenous vedolizumab 300-mg maintenance therapy every 8, 6, or 4 weeks. Maternal safety was also assessed. Results Vedolizumab was detectable in ~90% of milk samples collected from all patients. Following the day 1 dose, vedolizumab milk concentrations increased with a median of 3–4 days to peak concentration, and subsequently decreased exponentially. For the nine patients receiving vedolizumab every 8 weeks, the average relative infant dose was 20.9%. Using a mean trough serum concentration of 11.2 µg/mL from historical studies, the ratio of mean vedolizumab milk-to-serum concentration was ~ 0.4 to 2.2%, consistent with published data on vedolizumab and other monoclonal antibody therapeutics for inflammatory bowel disease. The maternal safety profile was similar to that observed in previous vedolizumab studies. Published vedolizumab studies also showed no adverse findings for infants breastfed by vedolizumab-treated mothers. Conclusions Vedolizumab was present in human breast milk at a low level. The decision to use vedolizumab should balance the benefit of therapy to the mother and the potential risks to the infant. Trial Registration ClinicalTrials.gov, NCT02559713; registered 24 September, 2015.

Certolizumab pegol (CERT) is indicated for reducing the signs and symptoms of Crohn's disease (CD) and maintaining clinical response. Patients losing response received an extra “capture” re-induction dose in the PRECiSE 4 study. We examined the use of certolizumab in a retrospective cohort of patients with CD at a single inflammatory bowel disease center.MethodsWe conducted a retrospective chart review of all adult patients with CD treated with CERT at the University of Chicago from April 22, 2008 to May 1, 2011. Demographics, disease characteristics, inflammatory bowel disease therapies, surgeries, CERT dosing, and clinical outcomes were recorded. Predictors of clinical response, re-induction dosing, and maintenance dose escalation were evaluated. Univariate, multivariate, and Kaplan–Meier analyses were performed for predictive variables of clinical response, re-induction dosing, and maintenance dose increases.ResultsOne hundred ten patients were identified; 23 were excluded. The remaining 87 patients had a sustained clinical response of 31.0%, remission of 14.9%, minimal or no response of 31.0%; 37.9% initially responded but lost response. In total, 35.6% of patients received a single re-induction dose of 400 mg after a mean of 29 weeks, predicted by prior anti–tumor necrosis factor (P = 0.007) and absence of perianal disease (P = 0.006); only 5 patients (16.1%) maintained a durable response or remission; 11.5% increased maintenance dosage after a mean of 50 weeks; all but 1 subsequently stopped CERT.ConclusionsSome patients with CD (31%) achieved a sustained response. The majority of patients receiving re-induction dosing did not achieve a sustained clinical response. Previous treatment with anti–tumor necrosis factor therapy was associated with reduced responses, suggesting that CERT may be more effective as an initial anti–tumor necrosis factor therapy.

Background Video capsule endoscopy (VCE) is indicated to evaluate for suspected small bowel bleeding, but “standard view” (SV) evaluation is time-consuming. Rapid Reader 6.0 software (Given Imaging, Duluth GA) contains two computer algorithmic systems: (1) “Quickview” (QV) which automatically skips similar images and (2) a pixel analysis program that identifies suspected blood (SBI). Combining the two modalities (QV + SBI) may provide a faster modality to assess for active small bowel bleeding. Aims This study was designed to assess the accuracy of QV + SBI for small bowel bleeding compared to SV findings. Methods This is a retrospective, case–control study at a single tertiary care referral hospital including all patients with VCE performed for suspected small bowel bleeding from 4/2007 to 3/2011. All studies were previously read using SV by one of two experienced faculty (CS, DR). The primary outcome was diagnostic accuracy of QV + SBI in assessing for active small bowel bleeding compared to SV. Results A total of 116 VCE were included, 28 with active small bowel bleeding identified by original SV. Using QV + SBI, all 28 VCEs with active small bowel bleeding were identified. The sensitivity of QV + SBI to detect active bleeding was 100 %, while the specificity was 93–94 %. The mean time to identify landmarks and read the entire study was 3 min 20 s. Conclusions The QV + SBI reading format of VCE is an efficient, highly sensitive modality to assess for potential small bowel bleeding.

Background: Emergency department (ED) patients often fail to follow‐up with referrals to outpatient clinics and physicians. Objective: To compare the effects of 2 ED discharge instructional methods on outpatient follow‐up compliance and to evaluate sociodemographic characteristics as possible factors affecting outpatient follow‐up compliance. Design and Participants: Randomized trial of ED patients. At discharge, the intervention group had their follow‐up appointment made and the standard group was given our hospital's referral service phone number to make their own follow‐up appointment. Measurements: Outpatient clinics were called 1 month after each subject's ED discharge to ascertain if they followed‐up. Poisson regression was used to examine the effects of sociodemographic factors on follow‐up compliance. RESULTS: Of 287 eligible subjects, 250 (87%) agreed to participate. Follow‐up rates were 59% for the intervention group and 37% for the standard group (P<.001). Having a primary care physicians appeared to increase ED patients' outpatient follow‐up compliance and having Medicaid insurance appeared to decrease outpatient follow‐up compliance, but neither of these findings was statistically significant. Conclusions: In our ED, patients who have their outpatient follow‐up appointment made at discharge have a significantly greater probability of follow‐up compliance compared with patients given standard discharge instructions. Most sociodemographic characteristics do not affect our ED patients' follow‐up compliance.

Limitation of a bioterrorist anthrax attack will require rapid and accurate recognition of the earliest victims. To identify clinical characteristics of inhalational anthrax, we compared 47 historical cases (including 11 cases of bioterrorism-related anthrax) with 376 controls with community-acquired pneumonia or influenza-like illness. Nausea, vomiting, pallor or cyanosis, diaphoresis, altered mental status, and raised haematocrit were more frequently recorded in the inhalational anthrax cases than in either the community-acquired pneumonia or influenza-like illness controls. The most accurate predictor of anthrax was mediastinal widening or pleural effusion on a chest radiograph. This finding was 100% sensitive (95% CI 84·6–100·0) for inhalational anthrax, 71·8% specific (64·8–78·1) compared with community-acquired pneumonia, and 95·6% specific (90·0–98·5) compared with influenza-like illness. Our findings represent preliminary efforts toward identifying clinical predictors of inhalational anthrax.