Citations

INTRODUCTION: Gender in ulcerative colitis (UC) is a well-studied topic with contradicting results with a slight male predominance seen in large population based studies in Olmsted County, Minnesota, while other studies have shown a slight female predominance. Yet, the relationship between UC and gender is not well-understood. Hence, it is unclear what is responsible for differences in gender. The aim of this study is to assess the inpatient prevalence and inpatients outcomes of UC by gender. METHODS: Case-control study using the NIS 2016, the largest public inpatient database in the US. All patients with ICD9-10CM codes for UC were included. None were excluded. Female patients were identified within the database using the female gender indicator. The primary outcome was determining the odds of UC in female patients compared to males. Secondary outcomes included determining inpatient morbidity, mortality, resource utilization, colectomy rates, hospital length of stay (LOS), and inflation-adjusted total hospital costs and charges. Propensity score matching was used to create a matching population for Charlson Comorbidity Index and age. Multivariate regression analyses were used to adjust for income in patient zip code, hospital region, location, size and teaching status. RESULTS: A total of 38, 950 patients with UC were identified and propensity matched for selected covariates. The mean patient age was 45, and 47.2% were female. For the primary outcome, females had decreased adjusted odds (aOR: 0.92, P < 0.01) of being admitted for UC. For secondary outcomes, female patients displayed lower adjusted odds of multi-organ failure, being placed on TPN, and undergoing colectomy. Females also had lower adjusted mean hospital costs, charges, and length of stay (LOS). All adjusted odds and means are displayed in Table 1. CONCLUSION: Females have lower inpatient prevalence of UC, complications, and economic burden compared to males. This reinforces the slight male predominance that was seen in the older Olmstead County population-based studies. One can speculate that the difference in complications, costs, charges, and LOS indicate that females have less severe disease at hospital admission. Numerous studies have examined the effect of gender on disease severity and outcomes, and there continues to be conflicting data. Thus, future studies are needed to determine what contributes to the variation in disease prevalence and course by gender, and possibly better tailor treatment regimens by gender.

INTRODUCTION: Solid organ transplant recipients are at increased risk of de novo malignancies, in some cases up to 15.6%. Data regarding pancreatic cancer following liver transplantation is limited. We aim to evaluate the incidence of pancreatic adenocarcinoma among liver transplant recipients in the United States. Describe survival in those patients and identify subgroup of patients at increased risk. METHODS: We examined the United Network of Organ Sharing (UNOS) database and identified patients with pancreatic adenocarcinoma who underwent liver transplant between 1988 and 2016. Patients 18 years of age and older were included. Demographics, primary diagnosis and survival data were recorded. Kaplan-Meier survival analyses and log-rank tests were performed. RESULTS: In the UNOS database, survival data regarding 142,488 patients was available and the cause of death was identified in 14,533 liver transplant recipients. A total of 140 patients developed pancreatic adenocarcinoma after liver transplantation. Most common indications for transplantations were Hepatitis C, alcohol cirrhosis and hepatocellular carcinoma (25 [17.9%], 24 [17.1%] and 9 [6.4%] respectively). Annual incidence was 16 pancreatic cancer cases per 100,000 transplant recipients. Compared to national annual incidence of 12.9 cancer cases per 100,000 patients, the relative risk was 1.23 (95% CI 0.59–2.56). Compared to other liver transplant recipients, those who developed pancreatic cancer were older and transplanted earlier in the time period evaluated ( P < 0.001 and P = 0.002 respectively). Gender, ethnicity, BMI, and primary diagnosis (i.e., transplant indication) were not significantly different among groups. Patient survival was significantly lower in patients who developed pancreatic adenocarcinoma (Log-rank test P < 0.001) (Figure 1). CONCLUSION: Analysis of the UNOS database showed that pancreatic adenocarcinoma is increased among liver transplant recipients without reaching statistical significance. Primary indications for transplantation and demographics were similar among both groups. Our findings suggest that pancreatic adenocarcinoma is more likely associated to long-standing immunosuppression and non-traditional risk factors rather than alcohol consumption or obesity. Further studies describing the natural history of pancreatic cancer after solid organ transplantation are suggested.

Abstract Background: Mild cognitive impairment (MCI) is an intermediate stage between the cognitive changes of normal aging and early dementia. Tai Chi (TC) may be particularly beneficial to patients with MCI due to its whole-body coordination characteristics. This systematic review protocol aims to outline the methods that will be used to assess the comparative effectiveness and safety of TC for MCI through a systematic review and meta-analysis. Methods: A systematic review will identify and evaluate randomized controlled trials (RCTs) that examined the effects and safety of TC compared to a placebo, conventional treatment, and no treatment on cognitive function in individuals with MCI. Studies from databases of MEDLINE, PubMed, Embase, Global Health, Cochrane Library, and Scopus from January 1990 to March 2019 reported in English will be searched. Two independent reviewers will screen the studies for inclusion with the eligibility criteria and extract data. Risk of bias of individual studies will be assessed in line with Cochrane risk of bias tool. The overall quality of cumulative evidence will be assessed using selected Grading of Recommendations, Assessment, Development, and Evaluations criteria. Statistics will be used for heterogeneity assessment, sensitivity analysis, data synthesis, generating funnel plots, and subgroup analysis. Meta-analysis will be performed, if sufficiently homogeneous studies are found. A narrative synthesis will be conducted, grouping studies by exposure and outcome definitions, and describing any differences by subgroups. Results: This study will provide practical and targeted evidence in investigating the impact of TC exercise for individuals with MCI. Conclusion: The findings of our study will provide updated evidence to determine whether TC is an effective intervention to patients with MCI. Trial registration number: International Prospective Register for Systematic Reviews (PROSPERO) number CRD42019125104.

Objectives To improve the trustworthiness of evidence, studies should be prospectively registered and research reports should adhere to existing standards. We aimed to systematically assess the degree to which endocrinology and internal medicine journals endorse study registration and reporting standards for randomised controlled trials (RCTs), systematic reviews (SRs) and observational studies (ObS). Additionally, we evaluated characteristics that predict endorsement of reporting or registration mechanism by these journals. Design Meta-epidemiological study. Setting Journals included in the ‘Endocrinology and Metabolism’ and ‘General and Internal Medicine’ 2017 Journal Citation Reports. Participants Journals with an impact factor of ≥1.0, focused on clinical medicine, and those who publish RCTs, SRs and ObS were included. Primary outcomes Requirement of adherence to reporting guideline and study registration as determined from the journals’ author instructions. Results Of the 170 (82 endocrinology and 88 internal medicine) eligible journals, endorsing of reporting standards was the highest for RCTs, with 35 (43%) of endocrine journals and 55 (63%) of internal medicine journals followed by SRs, with 21 (26%) and 48 (55%), respectively, and lastly, by ObS with 41 (50%) of endocrine journals and 21 (24%) of internal medicine journals. In 78 (46%) journals RCTs were required to be registered and published in adherence to the Consolidated Standards of Reporting Trials statement. Only 11 (6%) journals required registration of SRs. Internal medicine journals were more likely to endorse reporting guidelines than endocrine journals except for Strengthening the Reporting of Observational Studies in Epidemiology. No other journal characteristic proved to be an independent predictor of reporting standard endorsement for RCTs besides trial registration. Conclusion Our results highlight that study registration requirement and reporting guideline endorsement are suboptimal in internal medicine and endocrine journals. This malpractice may be further enhanced since endorsement does not imply enforcement, impairing the practice of evidence-based medicine.

Systemic mastocytosis (SM) is a rare clinical condition resulting from a clonal proliferation of abnormal mast cells. The clinical presentation may vary from mild cutaneous manifestations to aggressive systemic symptoms including intermittent episodes of anaphylaxis. We present a case of a 69-year-old male with abrupt and recurrent episodes of anaphylaxis with refractory distributive shock following cardiac surgery with cardiopulmonary bypass. Following a complex postoperative course, a bone marrow biopsy ultimately confirmed the diagnosis. Although rare, SM should be considered in the differential diagnosis of postoperative patients with unexplained and recurrent episodes of distributive shock.

AbstractBackgroundAn internal risk stratification algorithm was developed to decrease the risk of major adverse cardiac events (MACEs) during lead extractions (LEs).ObjectiveTo report upon the impact of a risk stratification algorithm (RISE [RIsk Stratification prior to lead Extraction] protocol) on outcomes of LEs in a high‐volume center.MethodsA retrospective review of a prospectively maintained LEs database was performed to identify features associated with MACEs. On the basis of the retrospective data, the RISE protocol differentiated LEs procedures into “High” and “Low” risk for occurrence of MACEs. High‐risk LEs included dual‐coil defibrillator lead (≥3 years), pacemaker and single‐coil lead (≥5 years), and any StarFix coronary sinus lead. During the prospective evaluation of the RISE protocol, “High‐risk” LEs were performed in an operating room (OR) or hybrid laboratory with the cardiac anesthesiologist, OR nursing team, perfusionist in the room, and a cardiac surgeon on the premises. “Low‐risk” LEs were performed in the electrophysiology (EP) laboratory with anesthesia provided by EP nursing team. The preintervention (pre‐RISE) and postintervention (post‐RISE) group spanned 19 and 40 months and consisted of 449 (632 leads) and 751 patients (1055 leads), respectively. The primary outcome of MACEs in the two groups was compared.ResultsProtocol compliance was 100%. The primary outcome of MACEs occurred in 15 patients (3.34%) before and 12 (1.6%) after implementation of the RISE protocol (P = .04).ConclusionRISE identified a low‐risk group where minimal resources are needed and allowed for rapid intervention in the high‐risk group that reduced the consequences of MACEs.

Background The rapid development and complexity of new x‐ray computed tomography (CT) technologies and the need for evidence‐based optimization of image quality with respect to radiation and contrast media dose call for an updated approach towards CT performance evaluation. Aims This report offers updated testing guidelines for testing CT systems with an enhanced focus on the operational performance including iterative reconstructions and automatic exposure control (AEC) techniques. Materials and Methods The report was developed based on a comprehensive review of best methods and practices in the scientific literature. The detailed methods include the assessment of 1) CT noise (magnitude, texture, nonuniformity, inhomogeneity), 2) resolution (task transfer function under varying conditions and its scalar reflections), 3) task‐based performance (detectability, estimability), and 4) AEC performance (spatial, noise, and mA concordance of attenuation and exposure modulation). The methods include varying reconstruction and tube current modulation conditions, standardized testing protocols, and standardized quantities and metrology to facilitate tracking, benchmarking, and quantitative comparisons. Results The methods, implemented in cited publications, are robust to provide a representative reflection of CT system performance as used operationally in a clinical facility. The methods include recommendations for phantoms and phantom image analysis. Discussion In line with the current professional trajectory of the field toward quantitation and operational engagement, the stated methods offer quantitation that is more predictive of clinical performance than specification‐based approaches. They can pave the way to approach performance testing of new CT systems not only in terms of acceptance testing (i.e., verifying a device meets predefined specifications), but also system commissioning (i.e., determining how the system can be used most effectively in clinical practice). Conclusion We offer a set of common testing procedures that can be utilized towards the optimal clinical utilization of CT imaging devices, benchmarking across varying systems and times, and a basis to develop future performance‐based criteria for CT imaging.

Abstract Background Platinum chemotherapy (carboplatin or cisplatin) + etoposide is the current 1L standard of care treatment (tx) for ES-SCLC. Despite high response rates on this regimen, patient (pt) outcomes remain poor. IMpower133 is a Ph1/3, double-blind, randomized, placebo (PBO)-controlled trial that is evaluating the efficacy and safety of adding PD-L1-inhibitor atezo or PBO to 1L tx for ES-SCLC (NCT02763579). Methods IMpower133 enrolled pts without prior tx for ES-SCLC; PD-L1 testing was not required. Pts were randomized 1:1 to four 21-day cycles of carboplatin (AUC 5 mg/mL/min IV, Day 1) + etoposide (100 mg/m2 IV, Days 1-3) with either atezo (1200 mg IV, Day 1) or PBO, then maintenance atezo or PBO until PD, unacceptable toxicity or loss of clinical benefit. Maintenance prophylactic cranial irradiation (PCI) was allowed per protocol, while definitive thoracic radiation (TR) was not. Coprimary endpoints were OS and investigator-assessed PFS. A key exploratory endpoint was outcomes by blood tumor mutation burden (bTMB) analyzed at prespecified cutoffs (≥ 16 vs &lt; 16 and ≥ 10 vs &lt; 10 mutations/Mb). Results Adding atezo to carboplatin + etoposide demonstrated significant improvement in efficacy (OS and PFS) in 1L ES-SCLC (Table). Survival benefits were consistent across key subgroups and prespecified bTMB cutoffs. 44 pts (22 in each arm [per ITT]) received PCI, and 7 (3 in atezo arm, 4 in PBO arm) received TR. Gr 3-4 tx-related adverse events (AEs) occurred in 57% of atezo pts vs 56% of PBO pts; serious tx-related AEs occurred in 23% vs 19%. Occurrence of CNS-related AEs in pts who had PCI are shown in the Table. Conclusion Adding atezo to carboplatin + etoposide resulted in a significant improvement in survival in this 1L ES-SCLC all-comers population. There were no new safety signals, including in pts who received PCI or TR. Atezo + carboplatin + etoposide may represent a new standard regimen for untreated ES-SCLC. Atezo + carboplatin + etoposiden = 201PBO + carboplatin + etoposiden = 202Co-primary endpointsMedian OS, mo12.310.3HR 0.70 (95% CI: 0.54, 0.91); P = 0.0069Median PFS, mo5.24.3HR 0.77 (95% CI: 0.62, 0.96) P = 0.017Secondary efficacy endpointsInvestigator-assessed confirmed ORR, %60.264.4Median DoR, mo4.23.9CNS-related AEs in pts who had PCI, n (%)a,bn = 23n = 21Headache8 (34.8)4 (19.0)Asthenia5 (21.7)2 (9.5)Dizziness2 (8.7)0Insomnia2 (8.7)1 (4.8)Fall2 (8.7)1 (4.8)aSafety population; safety analyses conducted according to tx received (1 pt randomized to the control arm received a dose of atezo).bIncludes AEs occurring in ≥ 2 patients. Citation Format: Aaron S. Mansfield, Stephen V. Liu, Aleksandra Szczęsna, Libor Havel, Maciej Kzrakowski, Maximilian J. Hochmair, Florian Huemer, György Losonczy, Melissa L. Johnson, Makoto Nishio, Martin Reck, Tony S. Mok, Sivuonthanh Lam, David S. Shames, Juan Liu, Fairooz Kabbinavar, Alan Sandler, Leora Horn. IMpower133: Primary efficacy and safety + CNS-related adverse events in a Ph1/3 study of first-line (1L) atezolizumab (atezo) + carboplatin + etoposide in extensive-stage SCLC (ES-SCLC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT199.