bluuebunny/crossref_metadata_2025 huggingface dataset:
Clinical Outcomes of Laparoscopic Versus Laparotomic Distal Gastrectomy in Gastric Cancer Patients: A Multilevel Analysis Based on a Nationwide Administrative Database in Japan
Authors: Shibao Kazunori , Fujino Yoshihisa , Joden Fumi , Tajima Tatehide , Nagata Jun , Sato Nagahiro , Fujimoto Kenji , Shinya Matsuda , Hirata Keiji
Published: July 2020

Background

The present study compared the short‐term outcomes and costs of laparoscopic distal gastrectomy (LDG) with those of open distal gastrectomy (ODG) for gastric cancer using a nationwide administrative database in Japan.

Method

Overall, 37,752 patients with gastric cancer who underwent distal gastrectomy at 1074 hospitals in the fiscal year 2012–2013 were evaluated using a diagnosis procedure combination database in Japan. We performed a retrospective analysis via a multilevel analysis (MLA) of the short‐term surgical results and costs of the LDG and ODG groups. The models included the age, sex, comorbid complications, smoking, body mass index (BMI), activity of daily living (ADL), stage, and the number of cases of gastrectomy per facility for adjustment. The in‐hospital mortality relative to the hospital volume was also compared.

Results

The LDG group required postoperative blood transfusion less frequently and had fewer postoperative complications, shorter hospitalization, and lower operative mortality than the ODG group. While this stage did not correlate with the in‐hospital mortality, the surgical method, age, sex, ADL, BMI, comorbidity, and yearly volume showed a correlation. A significant association in the in‐hospital mortality was observed between low‐ and very‐high‐volume hospitals.

Conclusion

In this large nationwide cohort of patients with gastric cancer using an MLA, LDG was shown to be safer with lower mortality and postoperative complication rates than ODG.
Comparison of Different Lactobacilli Regarding Substrate Utilization and Their Tolerance Towards Lignocellulose Degradation Products
Authors: Gubelt Angela , Blaschke Lisa , Hahn Thomas , Rupp Steffen , Hirth Thomas , Zibek Susanne
Published: July 2020

Fermentative lactic acid production is currently impeded by low pH tolerance of the production organisms, the successive substrate consumption of the strains and/or the requirement to apply purified substrate streams. We identified Lactobacillus brevis IGB 1.29 in compost, which is capable of producing lactic acid at low pH values from lignocellulose hydrolysates, simultaneously consuming glucose and xylose. In this study, we compared Lactobacillus brevis IGB 1.29 with the reference strains Lactobacillus brevis ATCC 367, Lactobacillus plantarum NCIMB 8826 and Lactococcus lactis JCM 7638 with regard to the consumption of C5- and C6-sugars. Simultaneous conversion of C5- and C6-monosaccharides was confirmed for L. brevis IGB 1.29 with consumption rates of 1.6 g/(L h) for glucose and 1.0 g/(L h) for xylose. Consumption rates were lower for L. brevis ATCC 367 with 0.6 g/(L h) for glucose and 0.2 g/(L h) for xylose. Further trials were carried out to determine the sensitivity towards common toxic degradation products in lignocellulose hydrolysates: acetate, hydroxymethylfurfural, furfural, formate, levulinic acid and phenolic compounds from hemicellulose fraction. L. lactis was the least tolerant strain towards the inhibitors, whereas L. brevis IGB 1.29 showed the highest tolerance. L. brevis IGB 1.29 exhibited only 10% growth reduction at concentrations of 26.0 g/L acetate, 1.2 g/L furfural, 5.0 g/L formate, 6.6 g/L hydroxymethylfurfural, 9.2 g/L levulinic acid or 2.2 g/L phenolic compounds. This study describes a new strain L. brevis IGB 1.29, that enables efficient lactic acid production with a lignocellulose-derived C5- and C6-sugar fraction.
Consultation on kidney stones, Copenhagen 2019: lithotripsy in percutaneous nephrolithotomy
Authors: Axelsson Tomas Andri , Cracco Cecilia , Desai Mahesh , Hasan Mudhar Nazar , Knoll Thomas , Montanari Emanuele , Pérez-Fentes Daniel , Straub Michael , Thomas Kay , Williams James C. , Brehmer Marianne , Osther Palle J. S.
Published: July 2020

Purpose

To evaluate the balance between existing evidence and expert opinions on the safety and efficacy of new technological improvements in lithotripsy techniques for percutaneous nephrolithotomy (PCNL).

Methods

A scoping review approach was applied to search literature in Pubmed, Embase, and Web of Science. Consensus by key opinion leaders was reached at a 2-day meeting entitled “Consultation on Kidney Stones: Aspects of Intracorporeal Lithotripsy” held in Copenhagen, Denmark, in September 2019.

Results

New-generation dual-mode single-probe lithotripsy devices have shown favourable results compared with use of ballistic or ultrasonic lithotripters only. However, ballistic and ultrasonic lithotripters are also highly effective and safe and have been the backbone of PCNL for many years. Compared with standard PCNL, it seems that mini PCNL is associated with fewer bleeding complications and shorter hospital admissions, but also with longer operating room (OR) time and higher intrarenal pressure. Use of laser lithotripsy combined with suction in mini PCNL is a promising alternative that may improve such PCNL by shortening OR times. Furthermore, supine PCNL is a good alternative, especially in cases with complex renal stones and large proximal ureteric stones; in addition, it facilitates endoscopic combined intrarenal surgery (ECIRS).

Conclusion

Recent technological improvements in PCNL techniques are promising, but there is a lack of high-level evidence on safety and efficacy. Different techniques suit different types of stones and patients. The evolution of diverse methods has given urologists the possibility of a personalized stone approach, in other words, the right approach for the right patient.
Rezidivierendes DMEK-Versagen
Authors: Matar C. , Seitz B. , Daas L.
Published: July 2020

Wir berichten über einen Fuchs-Endotheldystrophie-Patienten mit drei „Descemet Membrane Endothelial Keratoplasty“ (DMEK) bei rezidierendem Transplantatversagen mit Intraokulardruckerhöhung und cystoides Makulaödem. Bei der dritten DMEK wurde Herpes im Vorderkammeraspirat nachgewiesen und eine adäquate Therapie eingeleitet. Bei der 6 Monaten-Kontrolle blieb die Hornhaut klar, der Visus betrug 0,8, der Intraokulardruck lag im Normbereich und das Makulaödem bildete sich zurück. Entweder wurde eine latente Herpes simplex Virus(HSV)-Infektion des Patienten reaktiviert oder eine befallene Spender-Lamelle transplantiert mit Spender-zu-Wirt-zu-Spender „Ping-Pong“ Übertragung.
Oncological colorectal surgery during the COVID-19pandemic—a national survey
Authors: Brunner Maximilian , Krautz Christian , Kersting Stephan , Weber Georg F. , Stinner Benno , Benz Stefan R. , Grützmann Robert
Published: July 2020

Purpose

The aim of this study was to clarify the surgical supply situation of oncological colorectal patients in Germany during limitations of the OR caseload due to the COVID-19 pandemic.

Methods

Between 11th and 19th April 2020, all members of a consortium of German colorectal cancer centers were invited to participate in a web-based survey on the current status of surgical care situation of colorectal cancer patients in Germany.

Results

A total of 112 colorectal surgeons of 101 German hospitals participated in the survey. Eighty-seven percent of the participating hospitals had to reduce their total surgical caseload and 34% their surgical volume for oncological colorectal patients during COVID-19 pandemic. Restrictions of the surgical caseload were independent of the size of the hospital and the number of cases of COVID-19 in the federal state of the hospital. Sixteen percent of colorectal surgeons consider surgical limitations to be not justified and 78% to be justified only if the care of oncological patients is ensured. Ninety-five percent of the colorectal surgeons interviewed stated that all oncological colorectal patients with an indication for surgery should be operated in time, despite the current reservations for COVID-19 patients. For the majority of the respondents (63% and 51%, respectively), an extended waiting time for surgery of up to 2 weeks was acceptable for non-metastatic and metastatic patients, respectively.

Conclusion

In Germany, there is a temporarily relevant reduction of surgical volume in oncological colorectal patients. Most colorectal surgeons stated that oncological colorectal surgery should not be compromised despite the measures taken during the COVID-19 pandemic.
Erwartungserwartungen
Authors: Scheer Peter
Published: July 2020

Der radikale Konstruktivismus ist eine erkenntnistheoretische Strömung des letzten Jahrhunderts. Vor dem Hintergrund einer sich auflösenden Zeit-Raum-Konstante wurde es nötig, neue erkenntnistheoretische Konzepte zu erfinden. Der radikale Konstruktivismus basiert auf der Erkenntnis, dass wir nur das wahrnehmen können, was wir sensorisch-sinnlich an- und aufnehmen und kennt definitionsgemäß keine absolute „Wahrheit“ mehr. Wahrnehmung und Verarbeitung ist also ein immer individuell subjektives Phänomen, die Wirklichkeit ein Konstrukt, das im Einzelnen entsteht und handlungsleitend wird.

In der Interaktion zwischen Eltern, Kind und Arzt können und müssen die Wirklichkeitskonstruktionen naturgemäß unterschiedlich sein. Sowohl durch die emotionalen Bindungen, als auch durch die Annahmen über die Befindlichkeiten des Kindes. Die Konstruktionen des Arztes sind dabei durch die vom Souverän gegebene Macht der Wirklichkeitserklärung, die sich in den Gebilden Universität und Weiterbildung abbilden, als die „Richtigen“ gekennzeichnet. Denen haben sich die Eltern sozusagen von sich aus unterzuordnen, ansonsten werden sie als „non-compliant“ verurteilt. Anregungen, Ideen des Konstruktivismus in die eigene Reflexion aufzunehmen, werden gegeben.
Improving control effects of absence seizures using single-pulse alternately resetting stimulation (SARS) of corticothalamic circuit
Authors: Fan Denggui , Zheng Yanhong , Yang Zecheng , Wang Qingyun
Published: July 2020

Presently, we develop a simplified corticothalamic (SCT) model and propose a single-pulse alternately resetting stimulation (SARS) with sequentially applying anodic (A, “+”) or cathodic (C, “−”) phase pulses to the thalamic reticular (RE) nuclei, thalamus-cortex (TC) relay nuclei, and cortical excitatory (EX) neurons, respectively. Abatement effects of ACC-SARS of RE, TC, and EX for the 2Hz–4Hz spike and wave discharges (SWD) of absence seizures are then concerned. Them:non-off ACC-SARS protocol is shown to effectively reduce the SWD with the least current consumption. In particular, when its frequency is out of the 2 Hz–4Hz SWD dominant rhythm, the desired seizure abatements can be obtained, which can be further improved by our proposed directional steering (DS) stimulation. The dynamical explanations for the SARS induced seizure abatements are lastly given by calculating the averaged mean firing rate (AMFR) of neurons and triggering averaged mean firing rates (TAMFRs) of 2Hz–4Hz SWD.
Answering the Conventionalist Challenge to Natural Rights Theory
Authors: Christmas Billy
Published: July 2020

Ben Bryan argues that the strongest challenge to natural rights theory is to explain how it overcomes the Problem of Authority. Given that our natural rights are multiply realisable by a range of equally reasonable social conventions, how or why ought one particular realisation have authority? I argue that Thomistic and Kantian solutions to this problem do not count as solutions from natural rights theory, and therefore offer my own solution. When theories of natural rights describe the rights we have in terms that refer not only to moralised act-types, but rather, tell us which non-moralised act-types ought to be moralised in the relevant way, they avoid the Problem of Authority altogether. Such theories of natural rights are singularly realisable at the level of regulative conventional rules, and only multiply realisable at the level of constitutive conventional rules. The latter form of multiple realisability does not raise the Problem of Authority.
Epidemiology of hip fracture and the development of a FRAX model for Uzbekistan
Authors: Lesnyak O , Ismailov S , Shakirova M , Alikhanova N , Zakroyeva A , Abboskhujaeva L , Johansson H , Harvey NC , McCloskey E , Kanis JA
Published: July 2020

A prospective population-based survey in a region of the Republic of Uzbekistan determined the incidence of fractures at the hip. The hip fracture rates were used to create a FRAX® model to facilitate fracture risk assessment in Uzbekistan.

Objective

This paper describes the epidemiology of hip fracture in the Republic of Uzbekistan that was used to develop a country-specific FRAX® tool for fracture prediction.

Methods

During a 1-year (2016/17) prospective population-based survey in the Pap district of the Republic of Uzbekistan, hip fractures were prospectively identified from hospital registers, trauma centres and primary care and community sources. Age- and sex-specific incidence of hip fracture and national mortality rates were incorporated into a FRAX model for Uzbekistan. Fracture probabilities were compared with those from neighbouring Kazakhstan and Kyrgystan.

Results

Approximately 41% of hip fracture cases did not come to medical attention, and two thirds of patients overall were not admitted to hospital. The incidence of hip fracture applied nationally suggested that the estimated number of hip fractures nationwide in persons over the age of 50 years for 2015 was 16,764 and is predicted to increase more than three-fold to 60,272 in 2050. FRAX-based probabilities were higher in Uzbekistan than Kazakhstan or Kyrgystan.

Conclusion

The FRAX model should enhance accuracy of determining fracture probability among the Uzbek population and help guide decisions about treatment.
GARG: Anonymous Recommendation of Point-of-Interest in Mobile Networks by Graph Convolution Network
Authors: Wu Shiwen , Zhang Yuanxing , Gao Chengliang , Bian Kaigui , Cui Bin
Published: July 2020

The advances of mobile equipment and localization techniques put forward the accuracy of the location-based service (LBS) in mobile networks. One core issue for the industry to exploit the economic interest of the LBSs is to make appropriate point-of-interest (POI) recommendation based on users’ interests. Today, the LBS applications expect the recommender systems to recommend the accurate next POI in an anonymous manner, without inquiring users’ attributes or knowing the detailed features of the vast number of POIs. To cope with the challenge, we propose a novel attentive model to recommend appropriate new POIs for users, namely Geographical Attentive Recommendation via Graph (GARG), which takes full advantage of the collaborative, sequential and content-aware information. Unlike previous strategies that equally treat POIs in the sequence or manually define the relationships between POIs, GARG adaptively differentiates the relevance of POIs in the sequence to the prediction, and automatically identifies the POI-wise correlation. Extensive experiments on three real-world datasets demonstrate the effectiveness of GARG and reveal a significant improvement by GARG on the precision, recall and mAP metrics, compared to several state-of-the-art baseline methods.
Zelluläre Pathomechanismen der akuten Pankreatitis
Authors: Sendler Matthias , Lerch Markus M.
Published: July 2020

Das exokrine Pankreas produziert und sezerniert alle für die Verdauung wichtigen Enzyme. Die akute Pankreatitis ist eine Entzündungsreaktion der Bauchspeicheldrüse, die durch die vorzeitige Aktivierung dieser pankreatischen Verdauungsenzyme noch in den exokrinen Zellen selbst verursacht wird. Im weiteren Verlauf der Erkrankung kann dieser lokale pankreatische Schaden systemisch werden und zu schwerwiegenden Komplikationen führen wie z. B. Organversagen, systemischer Schock oder auch die Infektion der Pankreasnekrose bis hin zur Sepsis. Experimentelle als auch klinische Studien haben versucht, die komplexen Mechanismen, die hinter der Entstehung der Erkrankung stehen, aufzuklären. Neuste wissenschaftliche Arbeiten zeichnen ein immer komplexer werdendes Bild der Krankheitsentstehung. Neben der Aktivierung von Trypsinogen zu Trypsin, die als das Schlüsselereignis der Pankreatitis angesehen wird, rücken auch andere pathophysiologische Ursachen immer mehr in den Fokus wie z. B. endoplasmatischer Retikulum Stress (ER-Stress), eine fehlerhafte Autophagie und der gesteigerte mitochondriale Schaden. Neben diesen subzellulären Ereignissen spielt auch die Immunreaktion eine wichtige Rolle für den Verlauf und den Schweregrad der Erkrankung. Infiltrierende Leukozyten verstärken den lokalen Schaden noch einmal und induzieren eine systemische Immunantwort, die hauptverantwortlich für die systemischen Komplikationen ist. Parallel zu einer starken proinflammatorischen Reaktion, ausgehend vom entzündeten Pankreas, kommt es zu einer antiinflammatorischen Gegenregulation, die ebenfalls mit schwerwiegenden Komplikationen, wie z. B. der Infektion der Pankreasnekrose, einhergeht. Dieses komplexe Zusammenspiel verschiedener Zellen und Mechanismen stellt letztendlich das Gesamtbild der Erkrankung dar und macht bis heute eine kausale Therapie schier unmöglich.
Health monitoring of bolted joints using modal-based vibrothermography
Authors: Chi Xintian , Di Maio Dario , Lieven Nicholas A. J.
Published: July 2020

This article presents a novel modal-based vibrothermographic approach for health monitoring of loosening bolted joints in coupled structures. In this article, the theoretical background supporting this proposed approach is firstly presented. Through finite element analyses on a simple bolted structure with varying joint conditions achieved by adjustment of bolt loads, the relationship between the bolt load and the temperature increase in the vibrating bolted joint during vibrothermographic tests was revealed. Experimental vibrothermographic tests on a more complex structure were completed to verify the observations from the finite element analyses while demonstrating the viability of the vibrothermographic approach in a laboratory environment. It has been shown that this vibrothermographic approach was able to determine the stage of a bolted joint in its progression of failure by tracing the changes in the temperature increase in relevant regions during vibrothermographic tests. Moreover, additional tests have been performed to illustrate that this approach was effective even by using only the residual responses of the structure’s vibration that were away from the resonances, which indicates it is more applicable to structures with higher damping as such structures have stronger residual responses during vibration that can be utilized. In the concluding observations of the article, the procedure for practical application of this approach is summarized, and its potential for further development is discussed.
The effect of future land use changes on hydrologic ecosystem services: a case study from the Zala catchment, Hungary
Authors: Decsi Bence , Vári Ágnes , Kozma Zsolt
Published: July 2020

Maintaining and, where possible, improving the ecological status of our water resources are of particular importance for the future. So, one of the main drivers of landscape design must be to protect our waters. In this study, we carried out an evaluation of four hydrologic ecosystem services (HES) in the Zala River catchment area, the largest tributary of Lake Balaton (more than half of the lake’s surface inflow comes from the Zala River), Hungary. The lake has great ecological, economic and social importance to the country. We used the cell-based InVEST model to quantify the spatial distribution of flood control, erosion control and nutrient retention ecosystem services for phosphorus and nitrogen; then, we carried out an aggregated evaluation. Thereby, we localized the hot spots of service delivery and tested the effect of focused land use changes in critical areas of low performance on the examined four HES. Forests proved to have the best aggregated result, while croplands near the stream network performed poorly. The modelled change in land use resulted in significant improvement on nutrient filtration and moderate to minimal but improving change for the other HES in most cases. The applied method is suitable as a supporting tool at the watershed level for decision-makers and landscape designers with the aim of protecting water bodies.
4569 Burden of illness in idiopathic pulmonary fibrosis: A real-world cohort
Authors: Farrand Erica , Collard Harold
Published: July 2020

OBJECTIVES/GOALS: Studying IPF associated health care utilization (HRU) in real world settings, provides the opportunity to produce generalizable results that can directly inform models of care delivery. The objective of this study was to examine real-world differences in the natural history of annual HRU and treatment trends associated with IPF in a large, community-based population of patients with IPF, compared to matched non-IPF controls. METHODS/STUDY POPULATION: Cases of IPF were identified using case validated algorithms in the Kaiser Permanente Northern California adult population from 2000 to 2014. Each case was matched to at least one and no more than five non-IPF controls by age, sex, race/ethnicity and length of enrollment. The date of the first occurrence of the IPF-specific diagnostic code was considered the index date for cases and matched controls. Comorbidity burden and HRU was assessed in the five years pre- and post-index date, including hospitalizations, outpatient visits, use of diagnostic and monitoring studies and medications. Poisson generalized estimating equations models with robust standard errors were used to estimate adjusted case-control differences in HRU, accounting for clustering within matched sets. RESULTS/ANTICIPATED RESULTS: 691 patients were identified with incident IPF during the study period and matched to 3,452 control subjects. Demographics were well balanced between cases and controls due to matching. Patients with IPF had a higher burden of all selected co-morbidities and higher HRU compared to controls. In the pre-index period, IPF members had significantly higher rates of all diagnostic procedures (p < 0.001) and health care visits, with the exception of skilled nursing facility care (p < 0.001). The greatest relative difference was observed with use of Chest CT (RR = 245.94, 95% CI 117.04, 516.82). In the post-index period compared to controls, patients with IPF had higher rates of serial testing (p < 0.001) and inpatient and outpatient care including, all-cause hospitalization (1.55), emergency room visits (1.19), outpatient visits (1.18), and skilled nursing facility stay (1.35). DISCUSSION/SIGNIFICANCE OF IMPACT: Patients with idiopathic pulmonary fibrosis experience increased co-morbidity and healthcare resource utilization compared to controls. This increased burden extends beyond the index-period as previously documented and is true for a large real-world cohort. CONFLICT OF INTEREST DESCRIPTION: NA
4223 Changes in positive predictive value of cervical cytology following HPV vaccination
Authors: Teoh Deanna , Nam Gwiwon , Kulasingam Shalini , Vogel Rachel I.
Published: July 2020

OBJECTIVES/GOALS: To determine if current U.S. HPV vaccination rates have decreased dysplasia prevalence enough to decrease the positive predictive value (PPV) of abnormal cervical cytology. METHODS/STUDY POPULATION: This retrospective cohort study comprised a chart review of all patients 21-35 years of age who had at least 1 Pap test result within MHealth/Fairview 2016-2018. HPV vaccination data, cervical cancer screening data and dysplasia results were abstracted. Vaccinated was defined as receiving at least 1 dose of HPV vaccine, with subgroup analyses performed for those completing vaccination per ACIP guidelines and by age of initiation dichotomized as 21+ years versus <21 years. RESULTS/ANTICIPATED RESULTS: 49,764 patients meeting study criteria were identified. Among the entire study population, 10% had abnormal cytology results during the study period. Among the 4,928 patients with abnormal cytology, PPV for CIN2+ was lower among vaccinated individuals (13% vs. 18%; p < 0.0001). Among vaccinated individuals, PPV was lower among those completing vaccination (12% vs. 16% for incomplete vaccination; p = 0.04) and among those initiating vaccination at <21 years of age (9% vs 26% for 21+y; p < 0.0001). DISCUSSION/SIGNIFICANCE OF IMPACT: Among a population with low HPV vaccine coverage, the decrease in dysplasia prevalence among vaccinated individuals is resulting in a subsequent decrease in PPV of cervical cytology, particularly in those initiating vaccination prior to 21 years of age and among those completing the series. Confirmation of these results will call for changes in screening strategies for vaccinated individuals. CONFLICT OF INTEREST DESCRIPTION: Acelity: Industry grant for an investigator-initiated industry-sponsored clinical trial. Tesaro: Site PI for industry-sponsored clinical trial. NOTE: Funding from the industries above are unrelated to the research presented in the abstract.
4220 Cognitive Function and Relationships with Intervention Dropout, Adherence and Weight Loss
Authors: Szabo-Reed Amanda Nicole , Washburn Richard , Martin Laura , Savage Cary , Donnelly Joseph
Published: July 2020

OBJECTIVES/GOALS: Greater cognitive function (CF) is associated with adherence to prescription medications, better program adherence and weight loss (WL) following bariatric surgery. The purpose of this study was to evaluate the association between baseline CF, intervention dropout, adherence and 3-month WL. METHODS/STUDY POPULATION: 107 (Mage = 40.9 yrs.), overweight/obese (BMI = 35.6 kg/m2) men (N = 17) and women (N = 90) completed a 3-mo. WL intervention. Participants were asked to attend weekly behavioral sessions, comply with a reduced calorie diet and complete 100 min of moderate intensity physical activity (PA)/wk. CF tasks including Flanker (attention), Stroop (Executive control) and working memory, body weight and cardiovascular fitness (covariate) were assessed at baseline and 3-mos. Session attendance, adherence to PA and diet prescriptions and number of off-diet episodes were recorded weekly. RESULTS/ANTICIPATED RESULTS: Results indicated that attention was positively correlated with session attendance (p = 0.016), adherence to the diet (p < 0.01) and PA (p = 0.023). Executive control was positively correlated with WL (p = 0.042). Working memory (two tasks) was also positively correlated with WL (p = .017 and p = .025). Analysis of variance (ANOVA) indicated that baseline attention (p = .012) was positively related to WL and negatively associated with drop out (p < .05). Hierarchical linear regression showed executive control (p = .036, R2 = .054) and working memory (p = .013, R2 = .073 and p = .017, R2 = .068) were associated with WL when controlling for fitness. DISCUSSION/SIGNIFICANCE OF IMPACT: These results suggest that stronger baseline attention is associated with completion of a 3-mo. WL intervention. Executive control and working memory are associated with amount of WL achieved. Additional, larger and longer trials to assess the role of baseline CF on WL and evaluating the impact of interventions designed to improve CF on WL are indicated.
4491 Cumulative Childhood Trauma Load Across Race in Individuals with Alcohol Use Disorder
Authors: Byrd Nia , Stangl Bethany L. , Schwandt Melanie L. , Diazgranados Nancy , Ramchandani Vijay A.
Published: July 2020

OBJECTIVES/GOALS: Our objective was to investigate racial differences in experiencing multiple categories of childhood trauma (CT) and the differential impact on alcohol use in individuals with alcohol use disorder (AUD). We hypothesized that there would be a differential additive effect of CT categories endorsed and drinking behaviors between racial groups. METHODS/STUDY POPULATION: Participants were recruited through the NIAAA screening protocol where they completed alcohol-related assessments including a 90-day Timeline Followback (TLFB) and the Alcohol Use Disorder Identification Test (AUDIT). Structured Clinical Interviews for DSM disorders were conducted to identify participants with lifetime alcohol dependence (DSM-IV) or AUD (DSM-5) (N = 1152). Participants self-identified as Black or White completed the Childhood Trauma Questionnaire (CTQ) which assesses 5 types of CT: emotional abuse, physical abuse, sexual abuse, physical neglect, and emotional neglect, and were classified into 3 CT groups: no trauma, 1 type of trauma, and 2+ types of trauma endorsed. RESULTS/ANTICIPATED RESULTS: For Black participants (N = 583), 21.6% experienced no trauma, 21% experienced 1 type, and 57.4% experienced 2 or more types, with the most common being physical abuse and emotional neglect. For White participants (N = 569), 32.1% experienced no trauma, 20.6% experienced 1 type, and 47.3% experienced 2 or more types, with the most common being emotional neglect and emotional abuse. There were significant associations between CT groups, TLFB, and AUDIT measures. For Black participants, AUDIT-Harm and AUDIT Total were significantly different across the 3 CT groups (all p values <0.05). For White participants, Heavy Drinking Days was significantly different across the 3 CT groups (p = 0.028), with trends for AUDIT-Harm (p = 0.061) and AUDIT-Dependence (p<0.065). DISCUSSION/SIGNIFICANCE OF IMPACT: In individuals with AUD, there were significant positive associations between the number of CT categories endorsed and alcohol use across race, suggesting a cumulative effect of CT on risky alcohol use. Future work includes exploring personality and behavioral mediators of the relationship between cumulative trauma load and drinking.
4281 Developing a predictive tool to detect peripheral artery disease (PAD): Examining patient-reported symptoms in ischemic versus non-ischemic conditions (PREDICT PAD)
Authors: Brown Rebecca , Schorr Erica , Treat-Jacobson Diane
Published: July 2020

OBJECTIVES/GOALS: Objectives: The study goal is to identify discriminating symptom characteristics of PAD versus non-ischemic conditions to improve recognition. Just as nausea, back, and jaw pain were once thought to be unrelated to myocardial infarction and coronary artery disease, patient-reported symptoms of PAD are frequently overlooked as being a sign of PAD. METHODS/STUDY POPULATION: Methods: Using a prospective de novo population-based cross-sectional design we will link symptom descriptors to PAD disease status using diagnostic testing in individuals who report lower extremity or buttock symptoms (n = 100). Symptom descriptors will be obtained via questionnaires and structured interviews will be completed pre and post physical function tests. Using near infrared spectroscopy, we will measure calf muscle tissue oxygenation levels to further differentiate ischemic vs. non-ischemic symptoms during exercise. The primary outcome will be the diagnostic accuracy of patient-reported symptoms which discriminate between PAD and non-PAD conditions. Positive predictive value and accuracy will be calculated using receiver operating characteristic (ROC) curve and chi-square analysis. RESULTS/ANTICIPATED RESULTS: Results: Previous studies from which symptom descriptors have been obtained were from patients with known PAD, of which 85-88% of participants were male.1–2 Seventy-six percent of this sample thus far is female. Nationally, PAD prevalence is 20% in those over the age of 70 years, however 58% of our study participants tested positive for PAD (via ankle brachial index test).3 The most commonly reported symptoms of PAD are “numbness” and “aching” vs. those without PAD most commonly reporting “cramping”. These results trend against our current understanding of PAD symptomatology, which is that cramping is the cardinal symptom of PAD.4 Preliminary analysis suggests that balance is a sensitive and specific predictor of PAD. Recruitment is ongoing, therefore results are preliminary. DISCUSSION/SIGNIFICANCE OF IMPACT: Translation of the results will impact primary care and community health. Improved disease detection will position providers to refer patients to exercise therapy before symptoms become disabling. Understanding the diagnostic accuracy of symptoms prepares us to apply novel techniques, such as statistical modeling, to systematically predict PAD.
4264 Early Childhood and Prepubertal Overweight and Obesity are Associated with Earlier Pubertal Onset in Boys and Girls: A Prospective Birth Cohort Study
Authors: Chen Li-Kuang , Wang Guoying , Bennett Wendy , Wang Xiaobin
Published: July 2020

OBJECTIVES/GOALS: It is hypothesized that the global secular trend toward earlier puberty onset, with implications for many future health outcomes, is related to the obesity epidemic. This study aims to examine prospective associations between weight during specific developmental windows and timing of puberty onset. METHODS/STUDY POPULATION: This study includes 1,296 mother-infant dyads from the Boston Birth Cohort, a predominantly minority (>80% black/Hispanic), low-income, and urban prospective birth cohort recruited and followed between 1998 and 2019. Age at peak height velocity (APHV), a well-defined and standardized proxy for puberty onset, is derived by fitting height measurements recorded during clinical visits using a mixed effects growth curve model. Multiple linear regression is performed to examine the relationships between early childhood (ages 2-5y) and prepubertal (ages 6-9y) overweight and obesity, weight trajectories between these two periods, and APHV, while controlling for known contributors to early puberty. RESULTS/ANTICIPATED RESULTS: Compared to counterparts with normal BMIs, kids who were obese during ages 2-5y (boys: −0.21y, CI[−0.39, −0.04]; girls: −0.22y, CI[−0.39, −0.05]) or ages 6-9y (boys: −0.27y, CI[−0.43, −0.11]; girls: −0.37y, CI[−0.52, −0.23]) had an earlier APHV. Being overweight during ages 6-9y was also associated an earlier APHV (boys: −0.26y, CI[−0.46, −0.07]; girls: −0.26y, CI[−0.42, −0.10]). Looking at weight trajectories, kids who were persistently overweight or obese from ages 2-5y to ages 6-9y had an earlier APHV (boys: −0.28y, CI[−0.45, −0.12]; girls: −0.31y, CI[−0.46, −0.16]), as did girls with normal BMIs during ages 2-5y and who were overweight or obese during ages 6-9y (−0.45y CI[−0.64, −0.26]). DISCUSSION/SIGNIFICANCE OF IMPACT: The temporal and dose-response relationships seen in this historically understudied population suggests that childhood obesity is etiologically important in the development, and even programming, of early puberty. This has implications for prediction, prevention, and mitigation of health disparities.
4209 Early Electrographic Seizure Detection by Neuro ICU Nurses via Bedside Real-Time Quantitative EEG
Authors: Kaleem Safa , Kang Jennifer H. , Sahgal Alok , Hernandez Christian E. , Swisher Christa B.
Published: July 2020

OBJECTIVES/GOALS:

1.

Determine test characteristics of Neuro ICU nurse interpretation of real-time bedside qEEG for seizure detection

2.

Determine difference in time to detection of seizures between qEEG interpretation and raw cEEG reads

3.

Determine how seizure characteristics affect accuracy of qEEG reads

METHODS/STUDY POPULATION:

Subjects: Nurses caring for patients admitted to the Neuro ICU at Duke University Hospital who are initiated on cEEG.

Nurses evaluate qEEG display at the bedside on an hourly basis after undergoing a standardized qEEG training session. The standard practice of independent review of cEEG and treatment by the Neuro ICU team remains unchanged.

Post-hoc review of cEEG data by two blinded, board-certified neurophysiologists will be performed for each patient. The raw cEEG data will be scored for the number of seizures present per hour, background, seizure duration, and seizure spatial extent.

The time from first seizure occurrence to clinical recognition will be recorded.

RESULTS/ANTICIPATED RESULTS:

Thus far, 91 patients with 583 1-hour blocks of nurse interpretations have been studied, with 6 patients experiencing seizures while on study. Enrollment will be completed on 1/17/20

Preliminary data show a sensitivity of 95.8% (79.9%, 99.9%), specificity of 95.2 (93.1%, 96.8%), positive predictive value of 46.0% (36.9%, 55.4%), negative predictive value of 99.8% (98.7%, 99.9%), positive likelihood ratio of 19.8 (13.6, 28.9), negative likelihood ratio (0.04 (0.01, 0.3). All confidence intervals are 95%. False alarm rate is 0.05/hour.

Further analyses are pending completion of enrollment in January 2020.

DISCUSSION/SIGNIFICANCE OF IMPACT: Nurse interpretation of real-time bedside qEEG for seizure detection is feasible in the Duke Neuro ICU. QEEG functions well as a screening tool with good specificity and low false alarm rate. Use of qEEG by nurses could lead to shorter time to seizure detection, which may improve patient outcomes. CONFLICT OF INTEREST DESCRIPTION: Safa Kaleem, BS: Research reported in this publication was supported by a Pfizer Foundation grant and the Duke Clinical Translational Science Institute (CTSI). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Pfizer Foundation or the Duke CTSI. Jennifer H. Kang, MD: None to declare. Alok Sahgal, MD: None to declare. Christa B. Swisher, MD: Received speaker’s honorarium from EISAI and UCB.
4033 Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta-cell Function in Newly-Diagnosed Type 1 Diabetes
Authors: Ismail Heba M , Evans-Molina Carmella , DiMeglio Linda
Published: July 2020

OBJECTIVES/GOALS: Type 1 diabetes (T1D) results from the autoimmune destruction of insulin-producing β-cells. Emerging data suggest that differences in intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. The prebiotic high amylose maize starch (HAMS) alters the gut microbiome profile and metabolites positively by increasing production of beneficial short chain fatty acids (SCFAs) that have significant anti-inflammatory effects. HAMS also improves glycemia, insulin sensitivity and secretion in healthy non-diabetic adults. Further, an acetylated and butyrylated form of HAMS (HAMS-AB) that increases beneficial SCFA production, namely acetate and butyrate, has been safe and effective in disease prevention in mouse T1D models. The objective of the proposed study is to assess the effect of administering a prebiotic, such as HAMS-AB, on the gut microbiome profile, SCFA production, glycemia and β-cell function in humans with T1D. METHODS/STUDY POPULATION: We hypothesize that administration of HAMS-AB will (i) improve the gut microbiome profile in humans with T1D, (ii) increase SCFA production, and (iii) improve β-cell health, β-cell function and overall glycemia. We propose a pilot randomized controlled cross-over trial of HAMS-AB in 12 youth with newly-diagnosed T1D. We will use state-of-the-art markers to profile the gut microbiome (using 16S rRNA sequencing), measure stool SCFA levels (using gas chromatography), asses β-cell stress/death (by measuring proinsulin to C-peptide ratios) and glycemia (assessed by continuous glucose monitoring and HbA1c measurements). RESULTS/ANTICIPATED RESULTS: We expect that the use of HAMS-AB in newly diagnosed youth with type 1 diabetes will alter the gut microbiome profile (thus increasing the number of fermenters and SCFA levels), β-cell function and glycemia in humans with T1D. DISCUSSION/SIGNIFICANCE OF IMPACT: Given the unknown long-term effects of immune-modulatory therapy on those at risk for or those diagnosed with T1D, the use of a prebiotic such as HAMS-AB offers a simple, safe, yet inexpensive and tolerated dietary alternative approach to mitigating disease.
4063 Glycemic control in a weight management-focused group medical visits (WM/GMV) intervention: examining the moderating effects of body mass index (BMI)
Authors: Kobe Elizabeth , Coffman Cynthia J. , Jeffreys Amy S. , Yancy William S. , Zervakis Jennifer , Edelman David E. , Crowley Matthew J.
Published: July 2020

OBJECTIVES/GOALS: The impact of baseline BMI on glycemic response to group medical visits (GMV) and weight management (WM)-based interventions is unclear. Our objective is to determine how baseline BMI class impacts patient responses to GMV and interventions that combine WM/GMV. METHODS/STUDY POPULATION: We will perform a secondary analysis of Jump Start, a randomized, controlled trial that compared the effectiveness of a GMV-based low carbohydrate diet-focused WM program (WM/GMV) to traditional GMV-based medication management (GMV) on diabetes control. The primary and secondary outcomes will be change in hemoglobin A1c (HbA1c) and weight at 48 months, respectively. Study participants will be stratified into BMI categories defined by BMI 27-29.9kg/m2, 30.0-34.9kg/m2, 35.0-39.9kg/m2, and ≥40.0kg/m2. Hierarchical mixed models will be used to examine the differential impact of the WM/GMV intervention compared to GMV on changes in outcomes by BMI class category. RESULTS/ANTICIPATED RESULTS: Jump Start enrolled 263 overweight Veterans (BMI ≥ 27kg/m2) with type 2 diabetes. At baseline, mean BMI was 35.3 and mean HbA1c was 9.1. 14.5% were overweight (BMI 27–29.9) and 84.5% were obese (BMI ≥ 30). The proposed analyses are ongoing. We anticipate that patients in the higher BMI obesity classes will demonstrate greater reductions in HbA1c and weight with the WM/GMV intervention relative to traditional GMV. DISCUSSION/SIGNIFICANCE OF IMPACT: This work will advance the understanding of the relationship between BMI and glycemic response to targeted interventions, and may ultimately provide guidance for interventions for type 2 diabetes.
4575 Implementing a Workflow Management Tool for Clinical Trials
Authors: Hanson Laura Nelle , Weis Jennifer , Andrijasevic Sasa , Elcombe Sharon , Hardtke Rachel , Kukla Andrea , Sanders Linda
Published: July 2020

OBJECTIVES/GOALS: A workflow management tool is essential in order to help support consistent processes with transparency in next steps of the study process. Prior to this tool, staff has relied upon extensive training and coaching on the study process. While resources and guidelines exist, it requires additional time for staff to identify these resources and allows for confusion and rework. Implementation of a systematic workflow management tool was identified as a critical need in order to support streamlined processes, improve transparency and support business continuity, and to accelerate the study process. METHODS/STUDY POPULATION: This effort was undertaken as part of the Protocol Lifecycle Management effort to implement a comprehensive clinical trial management system for clinical research studies. Mayo Clinic has designed a workflow management tool within the Velos eResearch system. The workflow manager is dynamic and will present specific activities based on the study design and responses to data entered on the ad hoc forms. A Workflow Build group contributed to the design of the workflow in order to reflect appropriate, current operational processes. The workflow was vetted and validated with research teams. In addition to designing activities, planned dates and target timelines were established for relevant workflows to help promote transparency in the study start-up timelines and allow study staff to identify overdue activities. Study status controls were designed in the workflow to protect study staff from inadvertently changing the status until appropriate activities are complete. RESULTS/ANTICIPATED RESULTS: A dynamic workflow has been designed and implemented in the Velos eResearch system to support Mayo Clinic research sites. This system will be implemented February 24, 2020 to all consenting studies. DISCUSSION/SIGNIFICANCE OF IMPACT: The implementation of this workflow management tool is critical to help support research operations in a large, academic medical center. Benefits to implementation are expected to include improved transparency in the study status and next steps, reductions in rework due to confusion in next steps, better understanding from new staff in the appropriate study process, and improved timelines for study start-up. As we prepare for the implementation of the Velos eResearch system at Mayo Clinic, the workflow management tool has been identified in training sessions as a positive benefit.
4448 Mental Stress Induced Myocardial Ischemia as a Marker for Adverse Cardiovascular Events After MI
Authors: Almuwaqqat Zakaria , Lima Bruno , Young An , Sullivan Samaah , Shah Amit , Hammadah Muhammad , Garcia Ernest , Bremner Douglas , Raggi Paolo , Quyyumi Arshed , Vaccarino Viola
Published: July 2020

OBJECTIVES/GOALS: Young and middle-aged adults with a myocardial infarction (MI) represent an understudied group potentially with unique risk indicators such as emotional stress. We sought to investigate if mental stress-induced myocardial ischemia (MSIMI), a marker of cardiovascular vulnerability to psychological stress, is associated with poor outcomes among this population. METHODS/STUDY POPULATION: We studied 306 patients (150 women and 156 men) ≤61 years of age who were hospitalized for MI in the previous 8 months. Clinical, behavioral and psychosocial factors were assessed with standardized measures. Patients underwent myocardial perfusion imaging with mental stress (public speaking) and conventional stress (exercise or pharmacological testing). MSIMI and conventional stress-induced ischemia were defined as a new or worsening perfusion defect. Patients were followed for 3 years for adverse events, which were independently adjudicated. Cox proportional hazard models were used to estimate the association of MSIMI and CSIMI with a composite endpoint of recurrent MI or cardiovascular (CV) death with adjustment for demographic, clinical and psychosocial risk factors. RESULTS/ANTICIPATED RESULTS: The mean age of the sample was 50 years (range, 22-61). MSIMI occurred in 16% of the patients, and conventional ischemia in 35%. Over a 3-year follow-up, 28 individuals had a recurrent MI and 2 died due to cardiovascular causes. The incidence of the composite endpoint of MI or CV death was more than doubled in patients with MSIMI (20%) than those without MSIMI (8%), HR 2.6, 95%CI, 1.2-5.6. Further adjustment for demographic and clinical risk factors and depressive symptoms did not substantially change the relationship. In contrast, conventional stress ischemia was not significantly related to the outcome (HR 1.4, 95%CI, 0.6-3.0). DISCUSSION/SIGNIFICANCE OF IMPACT: Young and middle-aged individuals with MSIMI after MI have a >2-fold higher likelihood of recurrent MI and CV mortality compared with those without MSIMI. In this patient group, MSIMI is a better risk indicator than ischemia with a conventional stress. These findings point to psychological stress as an important determinant of risk in this patient population. Ischemia induced by mental stress is a potent risk indicator in young post-MI patients. Stress-reduction interventions may be especially beneficial in patients who show this abnormal response.