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Rossi, Luciano, Igor L. Freire, and Jesús P. Mena-Chalco. "Genealogical index: A metric to analyze advisor–advisee relationships." Journal of Informetrics 11, no. 2 (2017): 564–82. http://dx.doi.org/10.1016/j.joi.2017.04.001.
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Sax, Paul, Keri N. Althoff, Keri N. Althoff, et al. "LB-7. Weight Change in Suppressed People with HIV (PWH) Switched from Either Tenofovir Disoproxil Fumarate (TDF) or Abacavir (ABC) to Tenofovir Alafenamide (TAF)." Open Forum Infectious Diseases 7, Supplement_1 (2020): S846—S847. http://dx.doi.org/10.1093/ofid/ofaa515.1904.
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Abstract Background Weight gain in PWH occurred in both naïve and switch studies and is linked to use of integrase inhibitors (INSTIs) with varying associations with nucleoside reverse transcriptase inhibitors (NRTIs). One hypothesis is that gain associated with TAF when switching from TDF is a result of cessation of TDF-induced weight suppression. Methods The study evaluated weight change in suppressed PWH on INSTI+NRTIs switched from ABC or TDF to TAF. Eligible pts had HIV, were ≥ 18 yrs at index (date of switch), treatment-experienced with known prior regimen, suppressed at index (-12 to +1 mo) and 1 yr, ≥ 6 mo pre-index history, with weight measures at index and 1 yr, no current or pre-index use of protease inhibitor or non-nucleoside reverse transcriptase inhibitor. Univariate comparisons were performed using Χ2 for categorical and t-test for continuous variables; negative binomial model with log link function evaluated risk of gain ≥ 3% of body weight between groups accounting for age, gender, race, body mass index (BMI), CD4. Linear mixed effects model was used to estimate mean weight at index and 1 yr post switch. Results Of 970 pts, 828 (85%) switched from TDF to TAF and 142 (15%) from ABC to TAF. Groups were balanced by race, gender, index BMI [Table 1]. Figures 1a-b describe pre- and post-switch INSTI use. At 1 yr, mean unadjusted weight change was 1.4 kg in TDF and 0.2 in ABC group p=0.039. TDF to TAF had higher proportion of PWH with gain ≥ 3% vs ABC to TAF (40% vs 27% p=0.003); differences in gain ≥ 5% and ≥ 10% were not statistically significant (26% vs 22% p=0.323 and 10% vs 6% p=0.220). Pts who gained ≥ 3% were younger, with greater proportion of females, non-obese, with 1 prior regimen, and prior elvitegravir (EVG) use. In adjusted analysis TDF to TAF had higher risk of gain ≥ 3% vs ABC to TAF [Figure 2]. In sensitivity analysis accounting for EVG or dolutegravir (DTG) use, TDF to TAF also had higher risk of ≥ 3% gain vs ABC to TAF: adjusted risk ratio (aRR)= 1.38 [1.01–1.89] and aRR= 1.42 [1.02–1.97]. Table 1. Baseline (index) characteristics. Figures 1a-b. Distribution of pre switch and post switch INSTI use. Figure 2. Risk of weight gain ≥ 3% of body weight at 1 year post switch accounting for age, gender, race, index BMI, and CD4. Conclusion Switching from TDF to TAF in INSTI-based regimens had a greater risk of weight gain vs ABC to TAF. This difference persisted when accounting for impact of the INSTI agent in the current regimen. These data suggest that differences in weight gain between TAF and TDF are driven by removal of TDF-associated weight suppression. Disclosures Paul Sax, MD, Gilead (Consultant, Research Grant or Support)Janssen (Consultant)Merck (Consultant, Research Grant or Support)ViiV Healthcare (Consultant, Research Grant or Support) Keri N. Althoff, PhD, MPH, Gilead (Advisor or Review Panel member) Keri N. Althoff, PhD, MPH, All of Us Study (NIH) (Individual(s) Involved: Self): Consultant; MedIQ (Individual(s) Involved: Self): Consultant; TrioHealth (Individual(s) Involved: Self): Advisor or Review Panel member Todd T. Brown, MD, PhD, Gilead (Consultant)Merck (Consultant)Theratechnologies (Consultant)ViiV Healthcare (Consultant) Janna Radtchenko, MBA, Trio Health (Employee) Helena Diaz Cuervo, PhD, Gilead Sciences (Employee) Steven Santiago, MD, Gilead (Advisor or Review Panel member, Speaker's Bureau)Janssen (Speaker's Bureau) Graeme Moyle, MD, Theratechnologies (Consultant) Karam Mounzer, MD, Epividian (Advisor or Review Panel member)Gilead (Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau)Janssen (Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau)Merck (Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau)ViiV Healthcare (Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau) Richard Elion, MD, Gilead (Advisor or Review Panel member, Research Grant or Support, Speaker's Bureau)Janssen (Speaker's Bureau)Proteus (Research Grant or Support)ViiV Healthcare (Advisor or Review Panel member, Research Grant or Support)
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Mackey, Scott. "Commodity Trading Advisor Indexes And Alpha Generation Relationships." Journal of Applied Business Research (JABR) 30, no. 6 (2014): 1831. http://dx.doi.org/10.19030/jabr.v30i6.8897.
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This research investigates the trend following relationships between Commodity Trading Advisor (CTA) Indexes and a widely known trend following proxy Index using a database covering 21 years with 24 CTA, Managed Futures, and Hedge Fund (that can trade CTA-like) Indexes. The trend following relationships are tested using a modification of the Methodology employed by Baesel, Gonzalez-Heres, Chen, & Shin (2012). A unique Alpha adjustment is proposed to include the traditional Alpha plus or minus a reward or penalty for displaying relationships to the larger positive and negative returns of the trend following Index proxy. Results for the first sample period show evidence of at least some association of the returns of the trend following proxy to those of the individual CTA Indexes; however, most of the Indexes showed little to no statistical support for much traditional or adjusted Total Alpha generation. For the second sample period the regression results show that almost none of the Indexes had a statistically significant association with the monthly total returns of the trend following proxy Index. Instead, generally all of the Indexes showed the impact of the larger monthly returns of the trend following proxy Index such that the Alpha adjustments overall were positive and, on average, generated approximately 50% of the Total Alpha of the individual CTA Indexes.
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Ashfar, N. Shahul, J. Abalin Lurther, and L. Antro James. "Fx Calories Calculator & Fitness Advisor." International Journal on Cybernetics & Informatics 10, no. 2 (2021): 113–20. http://dx.doi.org/10.5121/ijci.2021.100213.
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Calorie counter to record and estimate number of calories we need to consume daily. “FITNESS START WITH WHAT WE EAT”. This project can also provide guidelines for gaining or losing weight. That have heard it way to get started with the very boring term dieting. A number of mobile fitness devices as well as smart watches have emerged on the technology landscape. Body Mass Index is a simple calculation using a person’s height and weight. A BMI of 25.0 or more is overweight, while the healthy range is 18.5 to 24.9. Serious fat-burning activity uses the large muscle groups of the body – the thighs and bottom, chest and back. The greater the overall recruitment of muscle, the higher the calorie expenditure. So in your workouts, That are much better off using, say, the rower than isolating your arms for maximum calorie burn.
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Haidar, Ghady, Ryan K. Shields, Cornelius J. Clancy, and Minh-Hong Nguyen. "Therapeutic Drug Monitoring (TDM) of Suspension (SUS), Extended-Release (ER), and Intravenous (IV) Posaconazole (POS) at a Large Transplant Center." Open Forum Infectious Diseases 4, suppl_1 (2017): S297. http://dx.doi.org/10.1093/ofid/ofx163.683.
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Abstract Background Data on ER and IV POS among organ transplant recipients (OTRs) are limited, and the role of TDM is unclear. Methods Retrospective study of patients (pt) receiving any formulation of POS who had serum troughs checked. Therapeutic was defined as 3 1 mcg/mL. Results We analyzed 88 pt and 340 levels (SUS: 88, ER: 197, IV: 55). Eighty-five pt were OTRs (97%), 73 were lung transplant recipients (LT) (83%), 17 had cystic fibrosis (CF) (19%). POS was used for treatment (70%) (probable aspergillosis (38%), possible aspergillosis (10%), mucormycosis (16%), other mycoses (6%)), prophylaxis (19%), and pre-emptive therapy (14%). POS was given for intolerance of or contraindication to other azoles (47%), salvage therapy (10%), resistance (19%), and failure to achieve therapeutic levels with other azoles (6%). Serum concentration/dose ratios were lower with SUS vs. ER/IV (P < 0.0001) but were similar in ER/IV groups (P = 0.51) (Figure). There was no difference in serum levels between pt receiving ER vs. IV POS at 300 mg once daily (median 1.2 vs. 1.3 mcg/mL, therapeutic 70% vs. 73%, P = 0.57 and >0.99, respectively). 3 pt had levels £ 0.2 mcg/mL on 300 mg ER: 2 had CF and had undergone LT (0.2 and 0 mcg/mL) and 1 had short-gut syndrome (0.1 mcg/mL). Sixty-six percent and 67 % of pt receiving ER or IV POS (300 mg once daily) achieved initial therapeutic levels, respectively; of these, 87% and 83% had median therapeutic follow-up levels, respectively. Serial levels were available for 7 pt whose dose was increased from 300 to 400 mg ER once daily for subtherapeutic levels. 4/7 pt achieved therapeutic levels on 400 vs. 0/7 on 300 mg ER once daily (P = 0.069). Metoclopramide use and CF were associated with subtherapeutic vs. therapeutic levels (25% vs. 4% and 37% vs. 13%, respectively, P = < 0.05). When pt with CF were excluded, neither age nor body mass index were associated with POS levels. CF pt had lower levels than non-CF pt on a dose of 300 mg ER once daily (median 0.8 vs. 1.3 mcg/mL, P = 0.018). Conclusion Therapeutic levels are more reliably achieved with ER & IV POS compared with SUS POS. Serial TDM is unnecessary for most, but is recommended for pt with CF or those on metoclopramide. Dose increases may effectively increase levels. Novel dosing strategies are needed for CF. Disclosures R. K. Shields, Astellas: Received research funding, Research support. Merck: Received research funding, Research support. C. J. Clancy, Merck: Received research funding, Research support. Astellas: Received research funding, Research support. Cidara: Received research funding, Research support. Astellas: Scientific Advisor, Advisory board. Merck: Scientific Advisor, Advisory board. Cidara: Scientific Advisor, Advisory board. Medicines Company: Scientific Advisor, Advisory board.
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Deng, Liurui, Yongbin Lv, Ye Liu, and Yiwen Zhao. "Impact of Fintech on Bank Risk-Taking: Evidence from China." Risks 9, no. 5 (2021): 99. http://dx.doi.org/10.3390/risks9050099.
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This article focuses on the relationship between Fintech and bank risk-taking behavior. Since Robo-Advisor is one of the mature applications of Fintech, we found that the development of Fintech will have a greater impact on small and medium-sized banks through the establishment of a Robo-Advisor model. This paper uses a benchmark regression model to analyze the municipal digital financial inclusion index compiled by Peking University and the annual report data of 155 small and medium-sized banks from 2011 to 2016. We found that the development of Fintech has significantly reduced bank risk-taking level. This result is still valid after the robustness test of replacing the bank’s risk-taking index and replacing the Fintech development index. We used the urban innovation index as an instrumental variable to deal with the endogenous problem, and obtained consistent estimation results. The test of the intermediary effect shows that the development of Fintech will affect the bank risk-taking through channels such as the bank’s internal interest margin, management capabilities, the bank’s external competition intensity, and residents’ saving willingness. Heterogeneity analysis shows the reduction effect of Fintech on bank risk-taking is more pronounced in banks in eastern and western regions in China, the large banks and the urban commercial banks.
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Mahmoud, K., A. Zayat, M. Y. MD Yusof, et al. "FRI0599 USEFUL II: DERIVATION OF THE LUPUS ARTHRITIS AND MUSCULOSKELETAL DISEASE ACTIVITY SCORE (LAMDA) USING DATA FROM A MULTICENTRE LONGITUDINAL STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 905.2–906. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2810.
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Background:Musculoskeletal (MSK) disease is the commonest manifestation of SLE. We showed that the MSK components of the BILAG index and SLEDAI have limited sensitivity, specificity and responsiveness compared to ultrasound (US) synovitis. The USEFUL study evaluated response to glucocorticoids in SLE patients with inflammatory pain.Objectives:To develop a disease activity tool for lupus MSK manifestations that is continuous, responsive, sensitive, and correlates with US-synovitisMethods:133 patients who received depomedrone 120mg IM were assessed at 0, 2 and 6 weeks for 66/68 swollen and tender joint counts, BILAG2004 index, SLEDAI-2K, physician global and MSK-VAS, inflammatory markers, patient pain and disease activity-VAS. Total US score (OMERACT-EULAR) in the hands and wrists was calculated blinded to patient and clinical assessor. Patients reported overall response using a Likert scale.The LAMDA was developed by modelling a core set of clinical variables against total US score using penalized (Lasso) regression. Responsiveness was compared between LAMDA and other variables at week 6 using effect sizes. Minimum clinically important difference (MCID) was explored using the SEM and minimal disease activity threshold using ROC.Results:The variables selected for the LAMDA score were swollen joint count, patient MSK pain VAS, physician MSK disease activity VAS and ESR. A continuous score was derived. This had a theoretical range from 0 to 26.5 based on maximum ESR of 100. The highest value observed in USEFUL was 15. LAMDA was significantly higher in patients with active US (mean (SD) 5.71 (2.67), n=78) compared to patients with normal US (3.27 (1.77), n=55; difference (95% CI) -2.45 (-3.26, -1.63), t=-5.93, p<0.001). This difference remained significant in patients with no swollen joints (difference (95% CI) -0.71 (-1.40, -0.02), t=-2.06, p=0.044).Effect size was greater for the LAMDA (0.37) than the BILAG-MSK (0.31), SLEDAI-MSK (0.27) and total US score (0.33). In patients with active US at baseline, LAMDA’s effect size was 0.42.The MCID was 0.71 and correlated with patient-reported change in pain. A threshold for minimal disease activity of 3.23 optimized sensitivity (0.77 (0.65, 0.89)) and specificity (0.80 (0.68, 0.92)) against US score >0.Conclusion:The LAMDA score is a novel continuous disease activity instrument for MSK manifestations of SLE derived from variables familiar to rheumatologists. The LAMDA score is sensitive to imaging detected synovitis without swelling and more responsive than other instruments. . LAMDA may improve the ability of clinicians to accurately determine therapeutic efficacy in clinical trials and practice. Future work will validate the LAMDA score in independent cohorts and randomized trials.Acknowledgements:This project was funded by Lupus UKDisclosure of Interests:Khaled Mahmoud: None declared, Ahmed Zayat: None declared, Md Yuzaiful Md Yusof: None declared, Coziana Ciurtin Grant/research support from: Pfizer, Consultant of: Roche, Modern Biosciences, Chee-Seng Yee: None declared, David Isenberg Consultant of: Study Investigator and Consultant to Genentech, Lee-Suan Teh: None declared, Katherine Dutton: None declared, David d’cruz Grant/research support from: GlaxoSmithKline, Nora Ng: None declared, Philip G Conaghan Consultant of: AbbVie, BMS, Eli Lilly, EMD Serono, Flexion Therapeutics, Galapagos, GSK, Novartis, Pfizer, Speakers bureau: AbbVie, Eli Lilly, Novartis, Pfizer, Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Christopher Edwards Grant/research support from: Abbvie, Biogen, Roche, Consultant of: Abbvie, Samsung, Speakers bureau: Abbvie, BMS, Biogen, Celgene, Fresenius, Gilead, Janssen, Lilly, Mundipharma, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, UCB, Elizabeth Hensor: None declared, Edward Vital Grant/research support from: AstraZeneca, Roche/Genentech, and Sandoz, Consultant of: AstraZeneca, GSK, Roche/Genentech, and Sandoz, Speakers bureau: Becton Dickinson and GSK
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Sachs, Tillmann, and Robert L. K. Tiong. "A Liquid and Investable Benchmark Index for the Commodity Trading Advisor and Managed Futures Industry." Journal of Index Investing 6, no. 4 (2016): 30–70. http://dx.doi.org/10.3905/jii.2016.6.4.030.
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Ahn, Wonbin, Hee Soo Lee, Hosun Ryou, and Kyong Joo Oh. "Asset Allocation Model for a Robo-Advisor Using the Financial Market Instability Index and Genetic Algorithms." Sustainability 12, no. 3 (2020): 849. http://dx.doi.org/10.3390/su12030849.
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There has been a growing demand for portfolio management using robo-advisors, and hence, research on the automation of portfolio composition has been increasing. In this study, we propose a model that automates the portfolio structure by using the instability index of the financial time series and genetic algorithms (GAs). We use the instability index to filter the investment assets and optimize the threshold value used as a filtering criterion by applying a GA. For an empirical analysis, we use stocks, bonds, commodities exchange traded funds (ETFs), and exchange rate. We compare the performance of our model with that of risk parity and mean-variance models and find our model has better performance. Several additional experiments with our model using various internal parameters are conducted, and the proposed model with a one-month test period after one year of learning is found to provide the highest Sharpe ratio.
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Mirás-Avalos, José, José Rubio-Asensio, Juan Ramírez-Cuesta, José Maestre-Valero, and Diego Intrigliolo. "Irrigation-Advisor—A Decision Support System for Irrigation of Vegetable Crops." Water 11, no. 11 (2019): 2245. http://dx.doi.org/10.3390/w11112245.
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Climate change will intensify water scarcity, and therefore irrigation must be adapted to save water. Operational tools that provide watering recommendations to end-users are needed. This work presents a new tool, Irrigation-Advisor (IA), which is based on weather forecasts and is able to separately determine soil evaporation and crop transpiration, and thus is adaptable to a broad range of agricultural situations. By calculating several statistical indicators, IA was tested against the FAO-56 crop evapotranspiration (ETcFAO) methodology using local crop coefficients. Additionally, IA recommendations were compared with current standard practices by experienced farmers (F). Six field experiments with four widely cultivated species (endive, lettuce, muskmelon and potato) were performed in Southeast Spain. Irrigation water applied, crop yield, aboveground biomass and water productivity were determined. Crop water needs underestimations (5%–20%) were detected when comparing IA against ETcFAO, although the index of agreement proved reasonable adjustments. The IA recommendations led to water savings up to 13% when compared to F, except for lettuce, with a 31% surplus in irrigation when using IA. Crop yield was not compromised and water productivity was increased by IA. Therefore, IA mimicked the farmers′ irrigation strategies fairly well without deploying sensors on-site. Nevertheless, improvements are needed for increasing the accuracy of IA estimations.
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Mankia, K., Z. Mustufvi, J. Kang, et al. "SAT0045 DISTRIBUTION AND SEVERITY OF PERIODONTITIS PREDICTS PROGRESSION TO INFLAMMATORY ARTHRITIS IN ANTI-CCP POSITIVE AT-RISK INDIVIDUALS WITHOUT CLINICAL SYNOVITIS." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 953. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5589.
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Background:The prevalence of periodontal disease and the citrullinating bacteriumPorphyromonas gingivalisare increased in anti-CCP positive individuals at-risk of rheumatoid arthritis (RA) (1). This suggests periodontal inflammation may have an important role in the initiation and development of RA. Despite significant interest in the role of the periodontium and other mucosal sites in the initiation of RA-related autoimmunity, the influence of mucosal inflammation on progression to inflammatory arthritis (IA) in at-risk individuals remains unclear.Objectives:To investigate the association between periodontitis and progression to inflammatory arthritis in anti-CCP+ at-risk individuals without synovitis.Methods:Anti-CCP positive individuals with musculoskeletal symptoms but no clinical synovitis (CCP+ at-risk) were recruited as part of a national prospective cohort study. Comprehensive periodontal examination was performed at baseline by a dentist; six sites per tooth were assessed for clinical attachment level (CAL), pocket depth (PD) and bleeding on probing (BOP). Periodontal disease sites (PDD) were defined as CAL ≥2mm and PD ≥4mm. The distribution of PDD was classified in line with recent guidelines (2). The severity i.e. total burden of periodontal inflammation, was quantified at patient level using the periodontal inflamed surface area (PISA) index(3). CCP+ at-risk were monitored for progression to IA. Multivariable Cox regression was used to assess the effect of PDD distribution and PISA on progression to IA.Results:126 CCP+ at-risk underwent full periodontal examination and were followed up for median 23.4 months (range 0.6 – 56.8 months). Mean age was 49 years, 86 (68%) were females. At baseline, 42(33%) subjects had no PDD, 51(40%) had localised PDD (<30% teeth with one or more PDD site) and 33 (26%) had generalised PDD (≥ 30% of teeth with one or more PDD site). Mean (SD) PISA for all subjects was 267(319)mm2. 31 subjects (25%) progressed to IA after median of 12.6 months (range 0.6 – 49.5 months). Progression to IA was significantly higher in subjects with localised PDD compared with those without PDD (33% vs 16%, HR (95% CI) 2.45 (1.02, 5.94) p=0.02), figure 1. Interestingly, this association was not seen in subjects with generalised PDD (19% progression, HR 0.68 (0.20, 2.32). In addition, severity (i.e. total burden) of periodontal inflammation (PISA) was not significantly predictive of progression to IA alone (HR 1.001 (0.999-1.002), p=0.08). However, when adjusting for distribution of PDD, PISA was significantly associated with progression to IA (HR 1.0016 (1.0003- 1.003), p=0.00163).Conclusion:Periodontal inflammation predicts progression to IA in CCP+ at-risk individuals without clinical synovitis. The severity (i.e. total burden) of periodontitis appears to be particularly predictive of progression to IA in patients with localised periodontitis. These data suggest periodontitis may be an important factor in the development of RA and provide rationale for periodontal intervention with the aim of arthritis prevention in at-risk individuals.References:[1] Mankia K et al, JAMA Network Open(2019)[2] Caton J et al, J Clin Periodontol(2018)[3] Nesse W et al, J Clin Periodontol(2008)Disclosure of Interests :Kulveer Mankia: None declared, Zhain Mustufvi: None declared, Jing Kang: None declared, Aradhna Tugnait: None declared, Robert Letton: None declared, Laurence Duquenne: None declared, Alastair Speirs: None declared, Val Clerehugh: None declared, Deirdre Devine: None declared, Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor)
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Andrew, Melissa K., Joon Hyung Kim, Sean Matthews, et al. "5. How Does Frailty Impact the Efficacy, Reactogenicity, Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine? A Secondary Analysis of the ZOE-50 and ZOE-70 Studies." Open Forum Infectious Diseases 7, Supplement_1 (2020): S2—S3. http://dx.doi.org/10.1093/ofid/ofaa417.004.
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Abstract Background Herpes zoster can negatively impact older adults’ health and quality of life. An adjuvanted recombinant zoster vaccine (RZV) has excellent vaccine efficacy (VE), including in older adults. Given that frailty is strongly associated with vulnerability to illness and adverse health outcomes, we studied how frailty impacts RZV VE, immunogenicity, reactogenicity, and safety. Methods In the ZOE-50 and ZOE-70 pivotal Phase 3 efficacy studies of RZV, 29,305 participants aged 50–96 received 2 doses of RZV vs. placebo in 1:1 randomization. In this secondary analysis (NCT03563183), a baseline frailty index (FI) was created retrospectively following previously validated methods using pre-existing comorbidities and patient reported outcomes. Participants were categorized as non-frail (FI≤ 0.08), pre-frail (FI=0.08–0.25) or frail (FI≥ 0.25) for stratified analyses. Results FI was calculated for 99.8% of participants included in this secondary analysis (n=26,976), and was balanced between RZV and placebo groups. 45.6% were pre-frail and 11.3% were frail. Mean age was 68.8 years; 58.1% were women. RZV VE against HZ was consistently above 90% for all frailty categories [non-frail: 95.8% (95%CI: 91.6–98.2), pre-frail: 90.4% (84.4–94.4), frail: 90.2% (75.4–97.0)]. The RZV group demonstrated robust antibody responses post-dose 2 across frailty categories. In the RZV group, the percentage of participants reporting solicited adverse events decreased with increasing frailty. Unsolicited medically attended visits and serious adverse events increased with frailty and were balanced between placebo and RZV groups. Conclusion The ZOE studies included older adults who were frail and pre-frail, and VE was high across frailty categories. Reactogenicity decreased with increasing frailty, and no safety concerns were identified in any frailty group. Disclosures Melissa K. Andrew, MD, PhD, MSc(Ph), GSK (Grant/Research Support, Research Grant or Support) Joon Hyung Kim, MD, GSK (Employee, Shareholder) Sean Matthews, MSc, GSK (Consultant) Christophe Dessart, MSc, GSK (Employee) myron J. levin, MD, Curevo (Advisor or Review Panel member)GlaxoSmithKline (Grant/Research Support, Advisor or Review Panel member)GlaxoSmithKline (Grant/Research Support, Advisor or Review Panel member)Merck Research Laboratories (Advisor or Review Panel member, GlaxoSmithKline)Merck Research Laboratories (Advisor or Review Panel member)Merck ResearchLaboratories (Advisor or Review Panel member) Lidia Oostvogels, MD, GSK (Shareholder) Megan Riley, PhD, GSK (Employee) Shelly McNeil, FRCPC, MD, GSK (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support, Other Financial or Material Support, honoraria for talks) Anne Schuind, MD, GSK (Employee, Other Financial or Material Support, own GSK stock options or restricted shares as part of renumeration) Desmond Curran, PhD, GSK (Employee, Shareholder)
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Freifeld, Alison G., Andrea Zimmer, Christopher Arnold, et al. "1016. Bloodstream Infection Survey in High-Risk Oncology Patients (BISHOP) With Fever and Neutropenia (FN): Predictors for Morbidity and Mortality." Open Forum Infectious Diseases 5, suppl_1 (2018): S302—S303. http://dx.doi.org/10.1093/ofid/ofy210.853.
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Abstract Background Blood stream infection (BSI) during neutropenia is associated with high risk for morbidity and mortality in patients with hematologic malignancies receiving chemotherapy or undergoing hematopoietic cell transplant (HCT). We sought to identify factors associated with increased risk for critical illness (CI) morbidities within 7 days of BSI with index FN following chemotherapy. Methods A prospective ongoing survey among 14 high-volume US cancer centers submitting clinical and microbiologic data from consecutive HM patients with blood stream infection (BSI) during first FN after cytotoxic chemotherapy or HCT. We evaluated factors influencing poor outcomes defined as critical illness (need for pressor support, mechanical ventilation, new pneumonia or new BSI) within 7 days of BSI with index FN. Concordance between antibiotic and BSI isolate was determined by investigator (AZ, AF) interpretation of susceptibility reports provided by each center compared with the initial antimicrobial regimen (IAR) used, for single organism bacteremias only. Results Among 294 FN bacteremic episodes (93 HCT) were 336 bacterial pathogens (48.5% Gram-negative [GN], 46.5% Gram-positive [GP], and 6% anaerobes). Death occurred in 11/294 (4%) and 41/294 (14%) had CI by day 8. At FN presentation, mean MASCC score of those with CI vs. those without was 16.9 vs. 18.6 (P = 0.03) and there was a trend toward higher mean PITT scores for patients with CI by day 8 vs. those without (1.54 vs. 0.82 (P = 0.08)). Among GN bacteremias, 15% developed CI vs. 14.5% in nonviridans group Streptococci (VGS) GP bacteremias, and 10.9% in VGS bacteremias (NS). Among patients with single organism bacteremias (88% of all BSI), mismatch of IAR coverage with isolate susceptibilities occurred in 16.7% (38/227). Among patients whom IAR was active vs. inactive against BSI isolate, 16% vs 14.3%, respectively, developed CI (P = 0.81). Conclusion These data indicate that the MASCC score applied to high-risk inpatients may be a predictor for CI in the first week after bacteremia FN. The PITT shows less correlation with poor outcomes. There was no association between isolate type (GN, GP, or VGS) and CI. Notably there was no association between mismatched BSI susceptibility and antimicrobial spectrum of the IAR and early CI. Disclosures A. G. Freifeld, Merck: Investigator, Research grant. A. Zimmer, Merck: Investigator, Research grant. S. Pergam, Merck: Consultant, Consulting fee. Chimerix: Consultant, Consulting fee. K. V. Rolston, Merck: Investigator, Research grant. JMI Laboratories: Investigator, Research grant. Shionogi (Japan): Investigator, Research grant. S. Shoham, Merck: Investigator and Scientific Advisor, Consulting fee and Grant recipient. Astellas: Investigator, Grant recipient. Shionogi (Japan): Investigator, Grant recipient. Gilead: Investigator, Grant recipient. Shire: Investigator, Grant recipient. T. J. Walsh, Merck: Grant Investigator, Research grant. Atellas: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research grant. Gilead: Scientific Advisor, Consulting fee. Allergan: Grant Investigator and Scientific Advisor, Consulting fee and Research grant. Scynexis: Grant Investigator, Research grant. Amplyx: Grant Investigator, Research grant. Shionogi: Scientific Advisor, Consulting fee. J. A. Young, GSK: Investigator, The University of Minnesota is reimbursed for contract costs associated with conducting clinical trials of vaccine. I receive no personal financial benefit. Y. Zhang, Merck: Investigator, Research grant. J. Meza, Merck: Investigator, Research grant.
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Soriano, Alex, Laura A. Puzniak, Matteo Bassetti, et al. "1612. Evaluation of the Use of Ceftolozane/Tazobactam for the Treatment of ESBL-producing Enterobacterales Infections Using International Data from SPECTRA (Study of Prescribing Patterns and Effectiveness of Ceftolozane/Tazobactam Real World Analysis)." Open Forum Infectious Diseases 7, Supplement_1 (2020): S800. http://dx.doi.org/10.1093/ofid/ofaa439.1792.
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Abstract Background There is a paucity of data on outcomes of patients with severe ESBL-producing Enterobacterales infections treated with empiric or directed ceftolozane/tazobactam (C/T). This study looked at the treatment patterns and outcomes associated with C/T use in the treatment of ESBL-producing Enterobacterales. Methods Data were collected from an international cohort of 32 hospitals in 6 countries as part of SPECTRA, a retrospective multicenter database of C/T use globally, from 2016 – 2019. All adult patients with an ESBL positive Enterobacterales sterile site culture and treated with ≥ 48 hours of C/T were eligible. Outcomes assessed were clinical success, 30-day mortality from index event and readmission. Results There were 59 patients with 121 ESBL positive isolates. Blood and urine were the most common sites of infection at 19.8% each, followed by respiratory (18.2%). E. coli (50%) and K. pneumoniae (30%) were the most common pathogens. On average patients had 2 positive ESBL isolates; median 1; range 1-15. Most patients had the same infection site and ESBL pathogen, however 13 had multi-site ESBL pathogens identified and only 2 had polymicrobial ESBL pathogens. Septic shock was observed in 14 (24%) patients; 29 (49%) were in the ICU at the onset of infection. The most common comorbid conditions were immunocompromised hosts (37%) and cardiac disease (32%). 29% of patients were transplant recipients, and 28% had a CrCl &lt; 50 ml/min. In most patients (71%), C/T was given as directed therapy (i.e., once culture results were available). C/T was given prior to culture results (i.e., as empiric therapy) in 17 (29%) patients, of which 77% had clinical success. C/T dose was 1.5 g in 49%. Only 2 of 10 patients with a respiratory source received the currently licensed 3 g dose. Overall, clinical success was observed in 36 (61%) patients. 30-day mortality was 12%. Readmissions occurred in 5%, of which 2 were infection related. Conclusion The role of newer non-carbapenem antibiotics in the treatment of severe ESBL infections is currently undefined. In a multinational patient database, C/T was found to be effective in severe infections caused by ESBL-producing Enterobacterales. Prospective studies are needed to further define the role of C/T in the setting of frequent drug-resistant Gram-negative pathogens. Disclosures Laura A. Puzniak, PhD, Merck (Employee) Matteo Bassetti, MD, Shionogi Inc. (Advisor or Review Panel member) Pamela Moise, PharmD, Merck & Co., Inc. (Employee, Shareholder) David Paterson, Accelerate (Speaker’s Bureau)BioMerieux (Speaker’s Bureau)BioMerieux (Advisor or Review Panel member)Entasis (Advisor or Review Panel member)Merck (Advisor or Review Panel member)Merck (Grant/Research Support)Merck (Speaker’s Bureau)Pfizer (Speaker’s Bureau)Shionogi & Co., Ltd. (Grant/Research Support)VenatoRx (Advisor or Review Panel member)
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Lagnf, Abdalhamid M., Sarah Jorgensen, Evan J. Zasowski, et al. "1073. Predictors of Vancomycin Switch or Escalation in Patients With Methicillin-Resistant Staphylococcus aureus Bloodstream Infection." Open Forum Infectious Diseases 5, suppl_1 (2018): S321. http://dx.doi.org/10.1093/ofid/ofy210.910.
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Abstract Background Vancomycin (VAN) is the primary agent for the treatment methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI). VAN is frequently combined with or switched to a second anti-MRSA agent for the treatment of serious BSI because VAN monotherapy has been linked to treatment failures. We aimed to determine the potential risk factors for patients with MRSA BSI who switched or had therapy escalated. Methods This was a multicenter, retrospective cohort study of adults (≥18 years) initially treated with VAN (&gt;24 hours) for MRSA BSI between 2006 and 2018. Patients with a respiratory source were excluded. Baseline clinical and infection characteristics were compared between patients who received VAN as the sole anti-MRSA agent and continued on VAN until discharge and patients who switched or had a second anti-MRSA agent added during their admission (switch/escalate group). Multivariable logistic regression was performed to identify independent predictors of therapy switch or escalation. Results A total of 195 patients were included (66 VAN and 129 switch/escalate). The mean (SD) age of the study population was 56 (15.5) years, 68.2% were male, and 81.0% were African-American. Most (80%) of patient had community-onset BSI. The median (IQR) Charlson Comorbidity index and Acute Physiology and Chronic Health Evaluation (APACHE) II scores were 3 (1–5) and 14 (8–20), respectively. The major sources of BSI were skin/soft tissue (24.6%), infective endocarditis (24.1%), and bone/joint (23.1%). Median (IQR) time to switch/escalation was 67 (44–97) hours. In multivariable logistic regression analysis, infective endocarditis (aOR 6.2, 95% CI 2.2–16), hospitalization in the past 90 days (aOR 2.0, 95% CI 1.0–4.0), and APACHE II (aOR 1.07, 95% CI 1.01–1.12) were independently associated with switch/escalation. Conclusion We have identified a number of baseline clinical and infection characteristics that should be taken into account for clinicians to predict the likelihood of switch or escalation in vancomycin treated patients with MRSA BSI. Further studies evaluating the impact of up front alternative therapies in these higher risk patients are needed. Disclosures S. L. Davis, Achaogen: Scientific Advisor, Consulting fee. Allergan: Scientific Advisor, Consulting fee. Melinta: Scientific Advisor, Consulting fee. Nabriva: Scientific Advisor, Consulting fee. Zavante: Scientific Advisor, Consulting fee. M. J. Rybak, Allergan: Consultant, Grant Investigator and Speaker’s Bureau, Research grant and Research support. Achaogen: Consultant, Grant Investigator and Speaker’s Bureau, Consulting fee, Research grant and Research support. Bayer: Consultant, Grant Investigator and Speaker’s Bureau, Consulting fee, Research grant and Research support. Melinta: Consultant, Grant Investigator and Speaker’s Bureau, Consulting fee, Research grant and Research support. Merck: Consultant, Grant Investigator and Speaker’s Bureau, Consulting fee, Research grant and Research support. Theravance: Consultant, Grant Investigator and Speaker’s Bureau, Consulting fee, Research grant and Research support. Sunovian: Consultant, Grant Investigator and Speaker’s Bureau, Consulting fee, Research grant and Research support. Zavante: Consultant, Grant Investigator and Speaker’s Bureau, Consulting fee, Research grant and Research support. NIAID: Consultant, Grant Investigator and Speaker’s Bureau, Consulting fee, Research grant and Research support.
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Minrui, Guo, and Cheng Lei. "Battery group parameter selection and dynamic simulation of pure electric vehicle." MATEC Web of Conferences 179 (2018): 01004. http://dx.doi.org/10.1051/matecconf/201817901004.
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The battery pack is one of the core components of pure electric vehicle, dynamic performance of the whole vehicle is closely related to the matching design of the battery, and is affected by the air resistance coefficient and the windward area of the whole vehicle. The dynamic indicators include maximum driving speed, 0-100km/h acceleration time and climbing grade, the battery parameters are designed and matched before the vehicle design, mainly analyze influence on the vehicle dynamic performance of the types of batteries, air resistance coefficient, windward area by the simulation software ADVISOR, and optimize the combination of these parameters. The results show that the dynamic performance of the vehicle reaches the initial design index and the dynamic performance of the vehicle is improved significantly.
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Stockhoff, Lena, Hannah Schneider, Tammo Lambert Tergast, Markus Cornberg, and Benjamin Maasoumy. "Freiburg index of post-TIPS survival (FIPS) a valid prognostic score in patients with cirrhosis but also an advisor against TIPS?" Journal of Hepatology 75, no. 2 (2021): 487–89. http://dx.doi.org/10.1016/j.jhep.2021.02.031.
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Hill, Joshua A., Richard T. Maziarz, Seung Hyun Moon, Aastha Chandak, Zhiji Zhang, and Michael Boeckh. "1089. Health Resource Utilization and Costs Associated with Multi-Virus Infection after Allogeneic Hematopoietic Cell Transplantation." Open Forum Infectious Diseases 7, Supplement_1 (2020): S573—S574. http://dx.doi.org/10.1093/ofid/ofaa439.1275.
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Abstract Background Reactivation or infection with multiple double-stranded DNA (dsDNA) viruses after allogeneic hematopoietic cell transplant (allo-HCT) has been associated with increased morbidity in single center studies. We used a large US claims database to compare health care reimbursements and health resource utilization (HRU) between allo-HCT patients with no versus multiple infections due to CMV, BKV, EBV, JCV, AdV, and HHV-6. Methods We used the Decision Resources Group Real World Evidence Data Repository to identify allo-HCT recipients from 1/1/12-12/31/17. We grouped BKV, EBV and JCV due to lack of specific diagnosis codes and calculated reimbursements from submitted charges using a reimbursement to charge ratio of 0.425. We describe reimbursements and HRU in the 1-year post allo-HCT for patients with 1 vs. 2 vs. ≥ 3 vs. no dsDNA viral infections. We also used a generalized linear model to determine reimbursements stratified by the presence or absence of any acute or chronic graft-versus-host diseases (GVHD) after adjusting for age, health plan, underlying disease, stem cell source, baseline costs, and follow-up time. Results Among the 13,363 allo-HCT patients, 3,878 (29%) were coded with CMV, 1,754 (13%) with BKV/EBV/JCV, 626 (5%) with AdV, and 561 (4%) with HHV-6. Further, 3,949 (30%) were coded with 1 virus, 1,069 (8%) with 2, 238 (2%) with ≥3, and 8,107 (61%) with none. The unadjusted mean reimbursements per patient group were: 1 virus, $431,614; 2, $639,097; ≥3, $964,378; none, $266,345 (Table 1). Adjusted reimbursements were significantly higher for each additional viral infection among patients with and without GVHD compared to patients with no viral infections (p&lt; .0001) (Figure 1). HRU also increased as the number of viral infections increased. Patients with multiple viruses had longer lengths of stay (up to 2.5 weeks for index, 5 weeks for readmissions), ICU days (up to 1.5 weeks for index and readmissions) and higher readmission rates (up to 3 times) (Table 1). Table 1: Economic burden and health resource utilization in the first year after allo-HCT, stratified by number of dsDNA viral infections Figure 1: Adjusted total reimbursements in the first year after allo-HCT, stratified by number of dsDNA viral infections and GVHD Conclusion Allo-HCT patients with multiple dsDNA viral infections have significantly higher health care costs and HRU in the first year after allo-HCT, irrespective of the presence of GVHD. Improved dsDNA virus prevention strategies may reduce costs and improve outcomes. Disclosures Joshua A. Hill, MD, Allogene (Consultant)Allovir (Consultant)Gilead (Consultant)Karius (Grant/Research Support, Scientific Research Study Investigator)Takeda (Grant/Research Support, Scientific Research Study Investigator) Richard T. Maziarz, MD, AlloVir (Consultant)Artiva Biotherapeutics (Board Member)Athersys (Advisor or Review Panel member)BMS/ Celgene (Consultant, Grant/Research Support, Scientific Research Study Investigator)CRSPR (Consultant, Scientific Research Study Investigator)Fate Therapeutics (Scientific Research Study Investigator)Incyte (Consultant, Scientific Research Study Investigator)Kite Therapeutics (Consultant)Novartis (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support)Omeros (Consultant, Grant/Research Support)PACT Pharma (Consultant) Seung Hyun Moon, MD, MPA, AlloVir (Employee, Shareholder) Aastha Chandak, PhD, AlloVir (Independent Contractor) Zhiji Zhang, MS, AlloVir (Independent Contractor) Michael Boeckh, MD PhD, AlloVir (Consultant)EvrysBio (Advisor or Review Panel member, Other Financial or Material Support, share options)Gilead (Consultant, Grant/Research Support)GSK (Consultant)Helocyte (Advisor or Review Panel member, Shareholder)Lophius (Grant/Research Support)Merck (Consultant, Grant/Research Support)SymBio (Consultant)VirBio (Consultant, Grant/Research Support)
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E Segaloff, Hannah, Joshua G. Petrie, Ryan E. Malosh, et al. "Influenza Vaccination and Treatment with Antiviral Agents Among Hospitalized Adults in the 2014–2015 and 2015–2016 Influenza Seasons." Open Forum Infectious Diseases 4, suppl_1 (2017): S316—S317. http://dx.doi.org/10.1093/ofid/ofx163.740.
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Abstract Background Vaccination and treatment with neuraminidase inhibitors can reduce incidence and severity of influenza. Observational studies suggest antiviral treatment reduces influenza symptom duration and severe outcomes among hospitalized patients. The interaction of the effects of vaccination and antiviral treatment against severe influenza has not been established. Methods We used data from a test-negative influenza vaccine effectiveness study. The parent study enrolled adults admitted to two hospitals in Michigan with an acute respiratory illness of ≤10 days duration during the 2014–2015 and 2015–2016 influenza seasons. Respiratory swabs from enrolled patients were tested for influenza by RT-PCR; influenza-positive individuals were included in this analysis. We evaluated predictors of vaccination and antiviral treatment using logistic regression. We also assessed the association between antiviral treatment and hospital length of stay (LOS) using linear regression models stratified by vaccination status. Results We included 200 individuals in the analysis; 103 (51.5%) were vaccinated and 135 (67.5%) were treated with antivirals. Significant predictors of vaccination included age ≥65, white race, a Charlson comorbidity index (CCI) score ≥3, study site, and increased past-year health care visits. Antiviral treatment varied by study site and was more common in the 2015–2016 season and among those aged 18–49. Vaccination was not associated with antiviral treatment or with time from illness onset to treatment. Antiviral treatment was associated with reduced LOS (percent change in LOS: −23.6% (−39.2%, −4.1%), P = 0.02) among vaccinated participants but not among unvaccinated participants (21.1% (−10.9%, 64.8%), P = 0.22) after adjustment for sex, age, influenza subtype, site, CCI, frailty, and past-year health care contacts. When an interaction term was used in lieu of stratification the interaction was significant (P = 0.01). This difference in antiviral effectiveness by vaccination status held across age groups, but was most dramatic for those aged 18–49. Conclusion Vaccinated individuals were more likely than unvaccinated individuals to benefit from antiviral treatment. This finding warrants confirmation in other populations. Disclosures A. S. Monto, sanofi pasteur: Grant Investigator, Research grant. Novartis: Consultant, Consulting fee. Protein Sciences: Consultant, Consulting fee. E. T. Martin, Pfizer: Scientific Advisor, Research grant. Merck: Scientific Advisor, Research grant. Multiparty Group For Advice on Science: Scientific Advisor, Research grant.
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Oyebode, Oyinlola, Hannah Patrick, Alexander Walker, Bruce Campbell, and John Powell. "THE GHOST IN THE MACHINE? THE VALUE OF EXPERT ADVICE IN THE PRODUCTION OF EVIDENCE-BASED GUIDANCE: A MIXED METHODS STUDY OF THE NICE INTERVENTIONAL PROCEDURES PROGRAMME." International Journal of Technology Assessment in Health Care 32, no. 1-2 (2016): 61–68. http://dx.doi.org/10.1017/s0266462315000690.
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Objectives: The aim of this study was to determine the aspects of expert advice that decision makers find most useful in the development of evidence-based guidance and to identify the characteristics of experts providing the most useful advice.Methods: First, semi-structured interviews were conducted with seventeen members of the Interventional Procedures Advisory Committee of the UK's National Institute of Health and Care Excellence. Interviews examined the usefulness of expert advice during guidance development. Transcripts were analyzed inductively to identify themes. Second, data were extracted from 211 experts’ questionnaires for forty-one consecutive procedures. Usefulness of advice was scored using an index developed through the qualitative work. Associations between usefulness score and characteristics of the expert advisor were investigated using univariate and multivariate analyses.Results: Expert opinion was seen as a valued complement to empirical evidence, providing context and tacit knowledge unavailable in published literature, but helpful for interpreting it. Interviewees also valued advice on the training and experience required to perform a procedure, on patient selection criteria and the place of a procedure within a clinical management pathway. Limitations of bias in expert opinion were widely acknowledged and skepticism expressed regarding the anecdotal nature of advice on safety or efficacy outcomes. Quantitative analysis demonstrated that the most useful advice was given by clinical experts with direct personal experience of the procedure, particularly research experience.Conclusions: Evidence-based guidance production is often characterized as a rational, pipeline process. This ignores the valuable role that expert opinion plays in guidance development, complementing and supporting the interpretation of empirical data.
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Bettinger, Dominik, Roman Kloeckner, Tobias Boettler, Robert Thimme, and Michael Schultheiss. "Reply to: “Freiburg index of post-TIPS survival (FIPS) a valid prognostic score in patients with cirrhosis but also an advisor against TIPS?”." Journal of Hepatology 75, no. 2 (2021): 489–90. http://dx.doi.org/10.1016/j.jhep.2021.04.028.
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Darijani, Fatemeh, Hadi Veisi, Houman Liaghati, Mohammad Nazari, and Kours Khoshbakht. "Assessment of Resilience of Pistachio Agroecosystems in Rafsanjan Plain in Iran." Sustainability 11, no. 6 (2019): 1656. http://dx.doi.org/10.3390/su11061656.
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This study assessed the resilience of pistachio production systems in the Rafsanjan plain in Iran using an index of behavior-based indicators. One-hundred fifty pistachio orchards located in five major production areas were studied in 2016. The data was subjected to three-step multi-criteria analysis, including (i) normalization and aggregation; (ii) determination of the weights representing the priorities for each criterion and evaluation of the performance of each indicator; and (iii) comparison. The results showed that the study areas had problematic statuses regarding the indicators of membership in grassroots organizations, innate abilities, water sources, production stability, and insurance. They had critical or moderate statuses concerning the indicators of use of organic fertilizers, use of pesticides, soil fertility index, water-use efficiency (kg/m3), trust in government, access to advisor services (extension), on-the-job training, and diversity of marketing. They had positive levels for the indicators of productivity, diversity of cultivars, diversity of on-farm practices, and exchange of information. We recommend the enhancement of the transformability capacity in PPSs by changing the focus from optimal states and the determinants of maximum sustainable yield (MSY paradigm) to adaptive resource management that includes developing participatory platforms for collaboration of usage of water resources.
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Jackson-Morris, Angela, and Ehsan Latif. "Index of tobacco control sustainability (ITCS): a tool to measure the sustainability of national tobacco control programmes." Tobacco Control 26, no. 2 (2016): 217–25. http://dx.doi.org/10.1136/tobaccocontrol-2015-052799.
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ObjectiveTo produce a tool to assess and guide sustainability of national tobacco control programmes.MethodA two-stage process adapting the Delphi and Nominal group techniques. A series of indicators of tobacco control sustainability were identified in grantee/country advisor reports to The International Union Against Tuberculosis and Lung Disease under the Bloomberg Initiative to Reduce Tobacco Control (2007–2015). Focus groups and key informant interviews in seven low and middle-income countries (52 government and civil society participants) provided consensus ratings of the indicators’ relative importance. Data were reviewed and the indicators were accorded relative weightings to produce the ‘Index of Tobacco Control Sustainability’ (ITCS).ResultsAll 31 indicators were considered ‘Critical’ or ‘Important’ by the great majority of participants. There was consensus that a tool to measure progress towards tobacco control sustainability was important. The most critical indicators related to financial policies and allocations, a national law, a dedicated national tobacco control unit and civil society tobacco control network, a national policy against tobacco industry ‘Corporate Social Responsibility’ (CSR), national mortality and morbidity data, and national policy evaluation mechanisms.ConclusionsThe 31 indicators were agreed to be ‘critical’ or ‘important’ factors for tobacco control sustainability. The Index comprises the weighted indicators as a tool to identify aspects of national tobacco control programmes requiring further development to augment their sustainability and to measure and compare progress over time. The next step is to apply the ITCS and produce tobacco control sustainability assessments.
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Ogimi, Chikara, Hu Xie, Alpana Waghmare, et al. "1523. Seasonal Human Coronavirus Infections Following Allogeneic Hematopoietic Cell Transplantation: Factors Associated With Lower Respiratory Tract Infection." Open Forum Infectious Diseases 7, Supplement_1 (2020): S763—S764. http://dx.doi.org/10.1093/ofid/ofaa439.1704.
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Abstract Background Proven/probable lower respiratory tract infection (LRTI) caused by seasonal human coronaviruses (HCoVs) is associated with mortality after hematopoietic cell transplantation (HCT). However, risk factors for LRTI and the significance of virologic documentation of lower respiratory tract involvement by bronchoalveolar lavage (BAL) on outcome are not well characterized. Methods Patients receiving allogeneic HCT between 4/2008 and 9/2018 with HCoV (OC43/NL63/HKU1/229E) detected in nasopharyngeal or BAL samples by PCR were retrospectively analyzed. Proven/probable LRTI was defined as having virus detected from a BAL sample with or without new pulmonary infiltrates by chest radiography, respectively. Possible LRTI was defined as having virus detected from an upper respiratory tract sample with new pulmonary infiltrates. We used logistic regression models to evaluate risk factors for LRTI in patients with first documented HCoV infection during pretransplant conditioning or post-HCT. Overall mortality following proven/probable and possible LRTI was compared by the log-rank test. Results A total of 297 patients (61 children and 236 adults) developed HCoV infection as follows: 254 had upper respiratory tract infection (URTI) alone, 18 presented with LRTI, and 25 progressed from URTI to LRTI [median 16 days (range, 2–62 days)]. Multivariable analyses showed that male gender, higher immunodeficiency scoring index, albumin &lt; 3 g/dl, glucose &gt; 150 mg/dl and presence of respiratory copathogen at HCoV diagnosis were associated with the occurrence of LRTI (Figure 1). Patients with proven/probable LRTI (N=16) had significantly worse survival than those with possible LRTI (N=37) (p=0.006, Figure 2). Figure 1. Figure 2. Conclusion Our analyses identified risk factors (hypoalbuminemia, male gender, high glucose and presence of respiratory copathogen) uncommonly appreciated for LRTI due to other respiratory viruses in HCT recipients. Whether these factors are also relevant to LRTI due to SARS-CoV-2 after HCT requires further studies. The association of hyperglycemia with LRTI might provide an opportunity to reduce the risk of LRTI. Disclosures Alpana Waghmare, MD, Amazon (Grant/Research Support)Amazon (Employee, Shareholder)Ansun Biopharma (Scientific Research Study Investigator)Kyorin Pharmaceuticals (Advisor or Review Panel member) Janet A. Englund, MD, AstraZeneca (Scientific Research Study Investigator)GSK group of companies (Scientific Research Study Investigator)Meissa vaccines (Consultant)Merck (Scientific Research Study Investigator)Sanofi Pasteur (Consultant) Michael Boeckh, MD PhD, AlloVir (Consultant)EvrysBio (Advisor or Review Panel member, Other Financial or Material Support, share options)Gilead (Consultant, Grant/Research Support)GSK (Consultant)Helocyte (Advisor or Review Panel member, Shareholder)Lophius (Grant/Research Support)Merck (Consultant, Grant/Research Support)SymBio (Consultant)VirBio (Consultant, Grant/Research Support)
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Fadilla, Nurul. "PENGARUH PENINGKATAN DANA BEASISWA BIDIKMISI TERHADAP HASIL BELAJAR MAHASISWA DI JURUSAN PENDIDIKAN EKONOMI FAKULTAS EKONOMI UNIVERSITAS NEGERI PADANG." Jurnal Ecogen 1, no. 2 (2018): 431. http://dx.doi.org/10.24036/jmpe.v1i2.4765.
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In taking a quality education and education to a higher level, a large fee is needed. The government in dealing with this problem, provides assistance in the form of a scholarship program. One of the scholarships provided by the government is the Bidikmisi scholarship. In early 2017 the government increased the bidikmisi scholarship fund received by students. This is so that students can improve their learning outcomes. This study aims to determine whether there is an effect of increasing bidikmisi scholarship funds on student learning outcomes in the Department of Economic Education, Faculty of Economics, Padang State University. This study uses a comparative causal type of research. The population in this study were students in the Department of Economic Education, Faculty of Economics, Padang State University, in 2014, 2015 and 2016. The sampling technique in this study used proportional sampling technique. The data used is the Achievement Index (IP) value of students before and after increasing the Bidikmisi scholarship fund from the Economics Education Department FE-UNP. The results of this study indicate that the increase in bidikmisi scholarship funds does not affect the learning outcomes of students in the Economics Education Department FE-UNP. Based on the results of the research, suggestions that can be given are (1) To the institutions and parties who provide bidikmisi scholarships it is advisable to be able to control the use of bidikmisi scholarships so that the scholarship funds can be used for academic needs so as to support the increase in student outcomes by asking for learning outcomes students to the Vice Dean 1 or Academic Advisor; (2) The parties involved with the Bidikmisi scholarship at UNP are advised to follow up on the implementation of bidikmisi scholarship financial misuse through periodic 1 (one) periodic reports; (3) Students who receive bidikmisi scholarships are advised to manage scholarship funds that are well received, in accordance with the purpose of scholarships that can support improvements in learning outcomes; (4) Further researchers are advised to continue and refine this research to be able to produce a more complete picture of the effect of Bidikmisi scholarship fund enhancement on student learning outcomes or the behavior of parents and students who receive bidikmisi scholarships. Keywords: Bidikmisi Scholarship, Learning Outcomes
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Koh, Shannon J., Dominique Van Beest, Jennifer Kargel, et al. "328. Outcomes in Spinal Cord Injury Patients with Stage 3 and 4 Pressure Injuries at a Veterans’ Affairs Hospital." Open Forum Infectious Diseases 7, Supplement_1 (2020): S236. http://dx.doi.org/10.1093/ofid/ofaa439.524.
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Abstract Background Pressure injuries (PI) and the complication of PI-related osteomyelitis (PIrOM), are a significant source of morbidity and mortality in spinal cord injury (SCI) patients. This study describes the epidemiology, healthcare utilization, and outcomes of SCI patients with PI at a large Veterans’ Affairs (VA) hospital. Methods We retrospectively reviewed all SCI patients with stage 3 or 4 PI in the pelvic area admitted to the VA North Texas SCI unit from 1/1/2013 to 12/31/2018. We abstracted demographic, diagnostic testing, treatment, and outcomes data from PI-related admissions for wound care from the electronic medical record. A composite definition categorizing the diagnosis of PIrOM was created (table 1). Two-sample t test and Fisher’s exact test were used to compare variables between flap patients (FP, those who received at least one flap surgery) and non-flap patients (NFP, those without any flap surgery). Table 1. Composite Definition for Pressure Injury-related Osteomyelitis Results A total of 78 patients, accounting for 113 hospitalizations, and 138 unique PI, were identified (table 2). Patients had a mean age of 59 years at index admission and male predominance (97%). Of the 138 PI, 49% were ischial and 88% were stage 4. There were 27 FP and 51 NFP. The mean Charlson Comorbidity Index was 4.9 overall and significantly higher in the NFP vs. FP (5.2 vs. 4.3, p=0.05). Diagnostics included at least one imaging study in 76% (n=86) of hospitalizations and a bone biopsy in 45% (n=51). Bone biopsy cultures were commonly polymicrobial (47%, n=24), with anaerobes, Staphylococcus aureus, and Streptococcus species being the most predominant organisms. A diagnosis of definite, probable, or possible PIrOM was made in 14%, 16%, and 41% of hospitalizations, respectively (table 3). Healthcare utilization was high, with a mean length of antibiotic therapy of 54 days and mean length of stay of 122 days per hospitalization. The rates of healed PI overall at discharge and at 1 year were 27% and 39%, and 12% and 40% in the NFP group. The 1-year mortality for NFP was 22%, while all FP were alive at one year. Table 2. Demographics and Comorbidities in SCI Patients with Stage 3 and 4 Pressure Injury Table 3. Healthcare Utilization, Osteomyelitis Classification, and Outcomes in PI-related Hospitalizations Conclusion Despite significantly high healthcare utilization, VA SCI patients with stage 3 and 4 PI had very poor wound outcomes and high mortality, particularly in NFP. Evidence-based, high value care paradigms are needed for this population and disease state. Disclosures Roger Bedimo, MD, Gilead Sciences (Consultant)Merck & Co. (Advisor or Review Panel member)ViiV Healthcare (Advisor or Review Panel member, Research Grant or Support)
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Bej, Taissa A., Brigid Wilson, Richard Banks, et al. "325. Invasive and Non-Invasive Osteomyelitis Caused by Group B Streptococcus Infection Among Veterans." Open Forum Infectious Diseases 7, Supplement_1 (2020): S234—S235. http://dx.doi.org/10.1093/ofid/ofaa439.521.
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Abstract Background Epidemiological studies that assess invasive Group B Streptococcus (GBS) infections may not capture cases of osteomyelitis diagnosed using non-invasive cultures in combination with imaging, laboratory tests, and clinical assessment. Here, we compare GBS osteomyelitis among individuals diagnosed using invasive and non-invasive cultures. Methods Using the Veterans Health Administration corporate data warehouse, we studied a national retrospective cohort review of Veterans diagnosed with GBS osteomyelitis between 2008 – 2017. Invasive cases were defined as an International Classification of Disease (ICD) code for osteomyelitis accompanied by a blood or bone culture positive for GBS within 2 weeks. Non-invasive cases were defined as an ICD code for osteomyelitis and a non-invasive culture positive for GBS from a concordant site within 2 weeks. We compared demographics, comorbid conditions, mortality, and time to below- or above-knee amputation among patients with invasive and non-invasive GBS osteomyelitis. Results We identified 1167 cases of invasive osteomyelitis among 1077 patients and 692 cases of non-invasive osteomyelitis among 644 patients. Most patients were male (98%) with an average age of 63.2 years (± standard deviation (SD) 10.1 years). The Charlson Comorbidity Index (CCI) was similar among patients with invasive and non-invasive disease (3.85 ± SD 2.3 and 3.83 ± SD2.4, respectively). Among those with lower extremity osteomyelitis, 11% of invasive cases had an amputation at 30 days while 2% of non-invasive cases had an amputation in the same time frame (Figure 1). Mortality was similar among those with invasive and non-invasive GBS osteomyelitis at 30-days (1% and 1%, respectively) and at 1-year (11% and 9%, respectively) (Figure 2). Figure 1: Time to Amputation Figure 2: Survival Conclusion Over 1/3 of the cases of osteomyelitis caused by GBS do not meet the case definition for invasive disease. Whether diagnosed using invasive or non-invasive microbiological cultures, survival outcomes for people with GBS osteomyelitis were similar. These findings suggest that non-invasive GBS osteomyelitis is as clinically important as invasive GBS osteomyelitis and that the rates of GBS osteomyelitis may be higher than previously reported. Disclosures Federico Perez, MD, MS, Accelerate (Research Grant or Support)Merck (Research Grant or Support)Pfizer (Research Grant or Support) Robin Jump, MD, PhD, Accelerate (Grant/Research Support)Merck (Grant/Research Support)Pfizer (Grant/Research Support, Advisor or Review Panel member)Roche (Advisor or Review Panel member)
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Cohen, Alexander T., Allison Keshishian, Theodore Lee, et al. "Safety and Effectiveness of Apixaban, LMWH and Warfarin Among Venous Thromboembolism (VTE) Patients with Active Cancer: A Subgroup Analysis of VTE Risk Scale." Blood 134, Supplement_1 (2019): 327. http://dx.doi.org/10.1182/blood-2019-126931.
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BACKGROUND: Cancer is an independent risk factor for venous thromboembolism (VTE) and the strongest predictor for all-cause and pulmonary embolism-related mortality. VTE risk is 4-7 times higher in cancer patients compared to non-cancer patients. Different cancer types are associated with different risk of VTE. Cancers of the brain, pancreas, stomach, liver, lungs, and kidneys-and hematologic malignancies-have the strongest association with the occurrence of VTE. The Khorana risk score based on the cancer type, blood counts, and body mass index is one of the VTE risk scales to predict the risk of thrombosis in cancer patients. This study evaluates the risk of major bleeding (MB), clinically relevant non-major (CRNM) bleeding, and recurrent VTE (non-fatal and fatal) among VTE patients with active cancer prescribed apixaban, low-molecular weight heparin (LMWH), or warfarin stratified by VTE risk. METHODS: A pooled study using four US commercial insurance claims databases identified VTE patients diagnosed with active cancer (defined as cancer diagnosis [any stage] or cancer treatment [chemotherapy, radiation, and cancer-related surgery] within 6 months before or 30 days after VTE diagnosis) who initiated apixaban, LMWH, or warfarin within 30 days following the first VTE event (01SEP2014-31MAR2018). Patients were followed to the earliest of: health plan disenrollment, death, index therapy discontinuation, switch to another anticoagulant, study end, or a maximum of 6 months. Stabilized inverse probability treatment weighting (IPTW) was used to balance treatment cohorts. A subgroup analysis using a modified Khorana VTE risk scale (cancer type only) was conducted. Patients were classified as very high risk (stomach, brain, or pancreas), high risk (lung, lymphoma, gynecologic, bladder, testicular, renal cell carcinoma), or other (all remaining cancer types) depending on their cancer type. Cox proportional hazard models were used to evaluate the risk of MB, CRNM bleeding, and recurrent VTE. The statistical significance (P&lt;0.10) of the interaction between treatment and different levels of VTE risk was evaluated. RESULTS: After applying the selection criteria, 3,393 apixaban, 6,108 LMWH, and 4,585 warfarin patients were identified with mean ages of 65, 64, and 64 years, respectively. After IPTW, all patient characteristics were balanced. Among all VTE cancer patients after IPTW, 15% of patients had very high-risk cancer and 40% patients had high-risk cancer. In the main analysis, apixaban patients had a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Warfarin patients had a similar risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Apixaban patients had a lower risk of recurrent VTE and a similar risk of MB and CRNM bleeding compared to warfarin (Figure). When stratifying by the VTE risk scale, study findings were generally consistent with the primary analysis and across the different subgroups. No significant interactions were observed for MB or CRNM bleeding (Figure). Two significant interactions were evident for recurrent VTE: apixaban trended towards a lower risk of recurrent VTE compared to LMWH across all three subgroups, but the magnitude of the difference was larger in the other cancer group vs. very high risk and high risk cancer groups. For warfarin vs. LMWH, different trends in recurrent VTE risk were observed among patients with different VTE risk levels (Figure). CONCLUSION: Across subgroups of VTE cancer patients with different VTE risk levels, apixaban had a lower risk of recurrent VTE compared to warfarin and a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH consistent with the overall results. Warfarin patients had a similar risk of MB and CRNM bleeding compared to LMWH. Further studies are needed to evaluate the role of anticoagulants in high-risk subgroups of VTE cancer patients. Figure Disclosures Cohen: Aspen: Consultancy, Speakers Bureau; CSL Behring: Consultancy; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Guidepoint Global: Consultancy; TRN: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Temasek Capital: Consultancy; Boston Scientific: Consultancy; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; GlaxoSmithKline: Consultancy, Speakers Bureau; AbbVie: Consultancy; GLG: Consultancy; Medscape: Consultancy, Speakers Bureau; McKinsey: Consultancy; Navigant: Consultancy; Takeda: Consultancy; ACI Clinical: Consultancy. Keshishian:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Lee:Pfizer Inc.: Employment, Equity Ownership. Wygant:Bristol-Myers Squibb Company: Employment. Rosenblatt:Bristol-Myers Squibb: Other: Stock Owner ; Bristol-Myers Squibb Company: Employment. Hlavacek:Pfizer Inc.: Employment. Mardekian:Pfizer Inc.: Employment. Wiederkehr:Pfizer Inc.: Employment. Sah:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Luo:Pfizer Inc.: Employment.
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Wilson, Brigid, Taissa A. Bej, Richard Banks, et al. "235. In outpatient clinics serving Veterans, antibiotic prescriptions precede a minority of antibiotic-associated adverse events." Open Forum Infectious Diseases 7, Supplement_1 (2020): S118. http://dx.doi.org/10.1093/ofid/ofaa439.279.
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Abstract Background An estimated 30% of antibiotic prescriptions in outpatient settings may be inappropriate. Antibiotic exposure increases an individual’s risk of Clostridioides difficile infection (CDI) and acquiring drug-resistant pathogens. To quantify the increased risk of CDI and drug-resistant pathogens posed by antibiotics prescribed in outpatient visits, we examined a two-year cohort of patients seen in primary care clinics at VA Community-Based Outpatient Clinics (CBOC) associated with a large VA Medical Center. Methods Among patients with an in-person visit at 13 CBOCs in 2018–2019, we examined rates of antibiotic-associated adverse events (AEs), defined as community-onset CDI or acquisition of resistant Gram-negative bacteria (R-GNB), in the 90 days following those visits. For each visit, we used administrative databases to determine if systemic antibiotics were prescribed, if there was an associated infectious diagnosis, and the subsequent occurrence of AEs. We summarized quarterly rates of prescribed antibiotics and AEs, characterized patients with and without AEs, and estimated the risk ratio of AE for an antibiotic prescription. Results Following 236,665 primary care visits, we observed 62 and 225 AEs due to CDI and R-GNB, respectively (0.12% combined rate) among 278 patients (5 with both). Patients who developed CDI or R-GNB had a higher Charlson Comorbidity Index (3.6 ± SD 3.0 and 2.68 ± SD 2.7, respectively) compared to those without AEs (0.72 ± SD 1.3; Table). The rate of new antibiotic prescriptions was 4% in visits without and 10% in visits with a subsequent AE, yielding a risk ratio of 2.5 (95% CI: 1.7–3.7). The rates of both antibiotic prescribing and AE were steady over the examined two-year period (Figure). Table Figure Conclusion Among all patients with a CBOC visit between 2018–2019, an AE, defined as CDI or R-GNB acquisition, was observed following only 0.1% of primary care visits. Among patients who experienced an AE, only 10% of primary care visits preceding those events included a new antibiotic prescription. While this analysis does not address antibiotics during inpatient stays or prescribed by specialty clinics, these findings suggest that among Veterans, outpatient antibiotic exposure may have only a modest contribution to the risk of AE. Disclosures Robin Jump, MD, PhD, Accelerate (Grant/Research Support)Merck (Grant/Research Support)Pfizer (Grant/Research Support, Advisor or Review Panel member)Roche (Advisor or Review Panel member) Federico Perez, MD, MS, Accelerate (Research Grant or Support)Merck (Research Grant or Support)Pfizer (Research Grant or Support)
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Cabrera, Nicolo, Truc T. Tran, Travis J. Carlson, et al. "1608. Efficacy of Ceftolozane/Tazobactam for Multidrug-Resistant Gram-Negative Infections in Multiple Urban Hospitals." Open Forum Infectious Diseases 7, Supplement_1 (2020): S798—S799. http://dx.doi.org/10.1093/ofid/ofaa439.1788.
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Abstract Background Ceftolozane/tazobactam (C/T) is a novel cephalosporin/beta-lactamase inhibitor combination developed for use against multidrug-resistant (MDR) Gram-negative infections, particularly Pseudomonas aeruginosa (PA). C/T is approved for complicated urinary tract and intraabdominal infections as well as hospital-acquired/ventilator-associated bacterial pneumonias. However, comprehensive clinical characterization of patients treated with C/T in non-FDA-approved indications is limited. Methods Patients ≥18 years who received C/T for ≥48 hours while hospitalized in 9 acute care centers in Houston, TX from January 2016 through September 2018 were included. Demographic, microbiologic, treatment and clinical outcome data were retrospectively collected by chart review. In patients who received multiple inpatient courses of C/T, only the first course with C/T was assessed. Results 210 patients met inclusion criteria: 58% were non-white, 35% were female and 13% were immunocompromised. Median age was 61 years (IQR, 48 to 69). Median Charlson comorbidity index was 5 (IQR, 2 to 6). At the onset of the index episode, a significant proportion of patients required intensive care unit admission (44%), mechanical ventilation (37%) and pressor support (22%). Respiratory sources were the most common (50%) followed by urine (15%). Positive cultures were documented in 93% of the cases and PA was found in 86%. Majority (95%) of PA which were MDR. C/T use was guided by susceptibility testing of the index isolate in ca. 52%. In 5.7% of cases, C/T was used to escalate therapy without any documented C/T-susceptible organism. Half (51%) of the cohort received initial dosing appropriate for renal function while 36% receiving a lower than recommended dose. Clinical success (i.e., recovery from infection-related signs and symptoms) occured in 77%. The in-hospital mortality rate in our cohort was 15% with 26 of 31 deaths deemed infection-related. Conclusion We report a large multicenter observational cohort that received C/T. A 77% clinical success with the use of C/T was documented. These data support the use of C/T in critically ill patients infected with MDR PA. Disclosures William R. Miller, MD, Entasis Therapeutics (Scientific Research Study Investigator)Merck (Grant/Research Support)Shionogi (Advisor or Review Panel member) Laura A. Puzniak, PhD, Merck (Employee) Cesar A. Arias, MD, MSc, PhD, FIDSA, Entasis Therapeutics (Scientific Research Study Investigator)MeMed (Scientific Research Study Investigator)Merck (Grant/Research Support)
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Benavidez, Gabriel, and Kelly Ylitalo. "A PRESCRIPTION FOR WELLNESS: EXERCISE REFERRALS FOR PATIENTS AT A FEDERALLY QUALIFIED HEALTH CENTER." Innovation in Aging 3, Supplement_1 (2019): S519. http://dx.doi.org/10.1093/geroni/igz038.1913.
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Abstract Physical activity improves quality of life and prevents or delays chronic disease, but most adults in the United States are inactive. Consultation and planning with a health care provider, specifically with an exercise “prescription,” may increase physical activity, but utilization patterns and success of such programs are not well understood. This study assessed the initial 6 months of an exercise prescription program at a large, federally-qualified health center during 2018 whereby adult patients were referred via prescription to personalized health coaching by a fitness advisor. A census of all adults (n=512) who received an exercise prescription was combined with attendance data from the on-site exercise facility to classify patients as never attended, 1 to 3 visits, and ≥4 visits. Ordinal logistic regression was used to examine patient characteristics from the electronic health record that influenced exercise facility attendance. Only 30.2% of adults (mean age 44.7 years (SD 14.4)) completed ≥1 visit and 21.7% completed ≥4 visits. We identified no significant utilization differences by sex, race/ethnicity, body mass index, diabetes, hypertension, or coronary artery disease, but adults aged ≥60 years had almost twice the odds of ≥4 visits (OR=1.97; 95% CI: 1.18, 3.33; p=0.01) compared to younger patients. Many adult patients did not participate in the exercise prescription program, but older adults were more likely to participate. Exercise prescription programs with personalized health coaching may be useful for older adult patients receiving care at a federally-qualified health center. Future work will examine if or how exercise prescriptions impact chronic disease self-management.
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Martani, Marlene, Hanny Juwitasary, and Arya Nata Gani Putra. "Analisis Alat Bantu Tuning Fisikal Basis Data pada Sql Server 2008." ComTech: Computer, Mathematics and Engineering Applications 5, no. 1 (2014): 334. http://dx.doi.org/10.21512/comtech.v5i1.2628.
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Nowadays every company has been faced with a business competition that requires the company to survive and be superior to its competitors. One strategy used by many companies is to use information technology to run their business processes. The use of information technology would require a storage which commonly referred to as a database to store and process data into useful information for the company. However, it was found that the greater the amount of data in the database, then the speed of the resulting process will decrease because the time needed to access the data will be much longer. The long process of data can cause a decrease in the company’s performance and the length of time needed to make decisions so that this can be a challenge to achieve the company’s competitive advantage. In this study performed an analysis of technique to improve the performance of the database system used by the company to perform tuning on SQL Server 2008 database physically. The purpose of this study is to improve the performance of the database used by speeding up the time it takes when doing query processing. The research methodology used was the method of analysis such as literature studies, analysis of the process and the workings of tuning tools that already exist in SQL Server 2008, and evaluation of applications that have been created, and also tuning methods that include query optimization and create index. The results obtained from this study is an evaluation of the physical application tuning tools that can integrate database functionality of other tuning tools such as SQL Profiler and Database Tuning Advisor.
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King, D., R. Chown, and J. Clarke. "Forty years on-contact tracing in Wakefield." International Journal of STD & AIDS 7, no. 5 (1996): 362–63. http://dx.doi.org/10.1258/0956462961918095.
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An audit of contact tracing activity for a range of common sexually transmitted diseases (STD) was performed prospectively on 100 consecutive referrals to the health advisers at the Genitourinary Medicine (GUM) clinic in Wakefield. Targets for contact attendance were set according to the initial index patient diagnosis. Health adviser contact tracing methods (telephone, letter, visit) were logged. A total of 119 contacts were identified; of these, 86 (73%) were seen and examined. Attendance within the target time of one working week was not achieved in gonorrhoea contacts, but 61% warts contacts attended within the target of 4 weeks. Tracing by patient-carried contact slips after interview with the health adviser was effective in the majority (68%) of notifications.
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Lodise, Thomas, Teena Chopra, Brian Nathanson, and Katherine Sulham. "1683. Hospital Admission Patterns in Adult Patients with Complicated Urinary Tract Infections (cUTIs): Identification of Potentially Avoidable Hospital Admissions Across United States (US) Hospitals." Open Forum Infectious Diseases 7, Supplement_1 (2020): S825—S826. http://dx.doi.org/10.1093/ofid/ofaa439.1861.
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Abstract Background There is an increase in hospital admissions for cUTI in the US despite apparent reductions in the severity of admissions. However, there are scant data on cUTI hospital admission rates from the emergency department (ED) stratified by age, infection severity, and presence of comorbidities. This study described US hospitalization patterns among adults who present to the ED with a cUTI. We sought to quantify the proportion of admissions that were potentially avoidable based on presence of sepsis and associated symtpoms as well as Charlston Comorbidity Index (CCI) scores. Methods A retrospective multi-center study using data from the Premier Healthcare Database (2013-18) was performed. Inclusion criteria: (1) age ≥ 18 years, (2) primary cUTI ED/inpatient discharge diagnosis, (3) positive blood or urine culture between index ED service days -5 to +2. Transfers from acute care facilities were excluded. Based on ICD-9/10 diagnosis codes present on admission, incidence of hospital admissions were stratified by age (≥ 65 years vs. &lt; 65 years), presence of sepsis (S), sepsis symptoms but no sepsis codes (SS) (e.g., fever, tachycardia, tachypnea, leukocytosis, etc.), and CCI. Results 187,789 patients met inclusion criteria. The mean (SD) age was 59.7 (21.9), 40.4% were male, 29.4% had sepsis, 16.7% had at least 1 SS symptom (but no S), and 53.9% had no evidence of S or SS. The median [IQR] CCI was 1 [0, 3]. 119,668 out of 187,789 (63.7%) were admitted to hospital. Among inpatients, median [IQR] length of stay (LOS) and total costs were 5 [3, 7] days and $7,956 [$4,834, $13,960] USD. Incidence of hospital admissions by age, presence of S/SS, and CCI score are shown in the Table. 18.9% of admissions (22,644/119,668) occurred in patients with no S/SS and a CCI ≤ 2. Their median [IQR] LOS and total costs were 3 [2, 5] days and $5,575 [$3,607, $9,133]. Incidence of Hospital Admission by Age, Charlson comorbidity index (CCI), Presence of Sepsis (S), and Presence of Sepsis Symptoms (SS) Conclusion Nearly 1 in 5 cUTI hospital admissions may be avoidable. Given the resources associated with the management of inpatients with cUTIs, these findings highlight the critical need for healthcare systems to develop well-defined criteria for hospital admission based on presence of comorbid conditions and infection severity. Preventing avoidable hospital admissions has the potential to save the healthcare system substantial costs. Disclosures Thomas Lodise, PharmD, PhD, Paratek Pharmaceuticals, Inc. (Consultant) Teena Chopra, MD, MPH, Spero Therapeutics (Consultant, Advisor or Review Panel member) Brian Nathanson, PhD, Spero Therapeutics (Independent Contractor) Katherine Sulham, MPH, Spero Therapeutics (Independent Contractor)
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Cohen, Alexander T., Allison Keshishian, Theodore Lee, et al. "Safety and Effectiveness of Apixaban, LMWH, and Warfarin Among Venous Thromboembolism Patients with Active Cancer: A Retrospective Analysis Using Four US Claims Databases." Blood 134, Supplement_1 (2019): 326. http://dx.doi.org/10.1182/blood-2019-121769.
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BACKGROUND: Venous thromboembolism (VTE) is the second leading cause of death in cancer patients. The treatment of cancer-associated VTE carries a significantly greater risk of major bleeding (MB) and recurrent VTE compared to that in non-cancer patients. CHEST Guidelines suggest the use of low molecular weight heparin (LMWH) over a vitamin K antagonist (VKA) in patients diagnosed with VTE and cancer. The last decade has seen an emergence of non-VKA anticoagulants (NOACs) for the treatment of VTE. Despite completed and ongoing clinical trials, there is a lack of real-world evidence comparing the effectiveness and safety of LWMH with VKAs and NOACs among VTE patients with active cancer. Therefore, this study evaluates the risk of MB, clinically relevant non-MB (CRNMB), and recurrent VTE (fatal or non-fatal) among VTE patients with active cancer prescribed apixaban, LMWH, or warfarin in routine clinical practice. METHODS: Four US commercial insurance claims databases were used to identify VTE patients with active cancer (defined as cancer diagnosis or cancer treatment [chemotherapy, radiation and cancer-related surgery] within 6 months before or 30 days after VTE diagnosis) who initiated apixaban, LMWH, or warfarin within 30-days following the first VTE event (01SEP2014-31MAR2018). Patients who used LMWH as bridging therapy for warfarin (≤14 days before or after warfarin initiation) were classified as warfarin users. Patients were followed to the earliest of: health plan disenrollment, death, index therapy discontinuation, switch to another anticoagulant, study end, or a maximum of 6 months. Additional analysis using all available follow-up was also conducted. Stabilized inverse probability treatment weighting (IPTW) was used to balance treatment cohorts. Cox proportional hazard models were used to evaluate the risk of MB, CRNMB, and recurrent VTE. RESULTS: After applying all eligibility criteria, 3,393 apixaban, 6,108 LMWH, and 4,585 warfarin patients were identified with mean ages of 65, 64, and 64 years, respectively. After IPTW, all patient characteristics were balanced. The mean follow-up was 105, 88, and 113 days for apixaban, LMWH, and warfarin, respectively. Among the weighted VTE cancer population, 51% of the patients had metastatic cancer and 77% of patients received cancer treatment. Further, 15% of patients had very high-risk cancer (brain, stomach, or pancreas), and 40% patients had high-risk cancer (lung, lymphoma, gynecologic, bladder, testicular, renal cell carcinoma). Apixaban patients had a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Apixaban patients also had a lower risk of recurrent VTE and a similar risk of MB and CRNM bleeding compared to warfarin. Warfarin patients had a similar risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH (Figure). When the entire available follow-up period (mean follow-up was 137, 106, and 166 days for apixaban, LMWH, and warfarin, respectively) was used, the trends were similar to the 6-month analysis for apixaban vs. LMWH and warfarin vs. LMWH. However, apixaban patients were associated with a lower risk of both MB and recurrent VTE compared to warfarin patients. CONCLUSION: VTE patients with active cancer initiating apixaban had significantly lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH patients. Apixaban patients also had a lower risk of recurrent VTE compared to warfarin patients. These results may be helpful for clinicians in evaluating different anticoagulation treatments for VTE patients with active cancer. Further studies are needed to evaluate these outcomes between different anticoagulation treatment options. Figure Disclosures Cohen: Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy; TRN: Consultancy; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Temasek Capital: Consultancy; ACI Clinical: Consultancy; Navigant: Consultancy; McKinsey: Consultancy; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy; Aspen: Consultancy, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Boston Scientific: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CSL Behring: Consultancy; GlaxoSmithKline: Consultancy, Speakers Bureau; GLG: Consultancy; Guidepoint Global: Consultancy; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Medscape: Consultancy, Speakers Bureau. Keshishian:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Lee:Pfizer Inc.: Employment, Equity Ownership. Wygant:Bristol-Myers Squibb Company: Employment. Rosenblatt:Bristol-Myers Squibb: Other: Stock Owner ; Bristol-Myers Squibb Company: Employment. Hlavacek:Pfizer Inc.: Employment. Mardekian:Pfizer Inc.: Employment. Wiederkehr:Pfizer Inc.: Employment. Sah:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Luo:Pfizer Inc.: Employment.
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Yoo, Rhena, and Martha Spencer. "Continence Promotion and Successful Aging: The Role of the Multidisciplinary Continence Clinic." Geriatrics 3, no. 4 (2018): 91. http://dx.doi.org/10.3390/geriatrics3040091.
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Incontinence is a common yet under-recognized issue that impacts quality of life, especially for older adults in whom there is often a multifactorial etiology. A retrospective chart review was performed on a representative sample of patients seen at our multidisciplinary continence clinic in Vancouver, Canada from January to December 2017 inclusive. Initial assessment was performed by the nurse continence advisor (NCA) or geriatrician depending on the source of referral. The pelvic floor physiotherapist (PFP) could then be consulted based on perceived need. The average age at assessment was 76 years old (range 29–102), with 82% of patients ≥65 years and 27% ≥85 years old. The majority of patients were referred for bladder incontinence (72%), with the remaining patients referred for bowel incontinence (28%) or pessary care (7%). Referrals came from a variety of sources including physicians (62%), nurses (22%), allied health care providers (12%) and self-referral (5%). Multimorbidity was common, with 40% of patients having a Charlson Comorbidity Index ≥6. The same proportion of patients (40%) were on ≥5 prescription medications. Many patients were functionally dependent for either instrumental activities of daily living (52%) or activities of daily living (25%). Non-pharmacologic treatments were commonly recommended, with the majority of patients counselled on lifestyle changes (88%) and taught Kegel exercises (70%). For patients seen by the geriatrician, modifications were made to non-continence medications in 50% of cases and medical comorbidities were optimized in 39% of cases. In terms of pharmacologic therapy, over-the-counter (OTC) medications were initiated in 45% of patients whereas continence-specific prescription medications were started in 17% of patients. A multidisciplinary continence clinic can play an important role in promoting successful aging by assessing and treating medical causes of incontinence in medically complex older adults.
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Jacobson, Caron A., Frederick L. Locke, David B. Miklos, et al. "End of Phase 1 Results from Zuma-6: Axicabtagene Ciloleucel (Axi-Cel) in Combination with Atezolizumab for the Treatment of Patients with Refractory Diffuse Large B Cell Lymphoma." Blood 132, Supplement 1 (2018): 4192. http://dx.doi.org/10.1182/blood-2018-99-111523.
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Abstract Background: Axi-cel is a US FDA-approved autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy for treatment of adult patients (pts) with relapsed or refractory large B cell lymphoma after ≥ 2 prior lines of therapy. In ZUMA-1, the pivotal study of pts with refractory large B cell lymphoma, the objective response rate (ORR) was 82%, including a 58% complete response (CR) rate (Neepalu and Locke, et al. N Engl J Med. 2017). Grade ≥ 3 cytokine release syndrome (CRS) and neurologic events were observed in 12% and 31% of pts, respectively, and were generally reversible. Checkpoint proteins, such as PD-1 and PD-L1, have been shown to be expressed on both CAR T cells and in the tumor microenvironment and subsequently upregulated after CAR T cell infusion (Vranic, et al. PLoS One. 2017; Cherkassky, et al. J Clin Invest. 2016; Galon, et al. ASCO 2017. #3025). This suggests that axi-cel activity could be augmented by incorporating PD-L1 blockade. This end of Phase 1 analysis of ZUMA-6 examines the safety and preliminary efficacy of axi-cel in combination with the anti-PD-L1 antibody atezolizumab (atezo) in pts with refractory diffuse large B cell lymphoma (DLBCL; NCT02926833). Methods: Eligible pts (≥ 18 years) with refractory DLBCL, defined as stable or progressive disease to last line of therapy or relapse within 12 months after autologous stem cell transplant, must have recieved prior CD20-targeting and anthracycline-containing regimen and had ECOG ≤ 1 and adequate bone marrow and organ function. Pts received low-dose conditioning with fludarabine 30 mg/m2/day and cyclophosphamide 500 mg/m2/day × 3 days followed by axi-cel infusion at a target dose of 2 × 106 cells/kg. Atezo was administered at 1200 mg every 21 days for 4 doses starting on Day 21, 14, and 1 post-axi-cel infusion for Cohorts 1, 2, and 3, respectively. This report describes Phase 1 results from all 3 cohorts. Incidence of dose-limiting toxicities (DLTs) was the primary endpoint. Secondary endpoints included the frequency of adverse events (AEs), disease response, pharmacokinetics, and biomarkers. Results: As of January 19, 2018, 12 pts have received axi-cel and at least 1 dose of atezo (3 in Cohort 1; 3 in Cohort 2, 6 in Cohort 3). Median age was 55 years (range, 30 - 66). Most pts (9/12, 75%) had received ≥ 3 prior therapies, and 4 pts (33%) had an International Prognostic Index score of 3 or 4. The median follow-up from axi-cel infusion was 4.4 months (range, 0.8 - 12.6), with 50% of pts having ≥ 6 months of follow-up. Eight pts (67%) have received all 4 doses of atezo, and 11/12 pts have received all scheduled doses of atezo. One pt in Cohort 3 experienced a DLT of Grade 4 thrombocytopenia and neutropenia lasting longer than 30 days. All pts experienced at least 1 AE (92% Grade ≥ 3), with no apparent exacerbation or recurrence of axi-cel-related toxicity following atezo infusion. Only 1 Grade ≥ 3 AE was attributed solely to atezo. Overall, the most common grade ≥ 3 AEs were anemia (9/12, 75%), encephalopathy (5/12, 42%), and neutropenia (5/12, 42%). Grade ≥ 3 CRS and neurologic events occurred in 3 (25%) and 6 (50%) pts, respectively. The ORR in evaluable pts was 9/10 (90%), with 6 pts (60%) in CR and 3 (30%) in partial response (PR); 2/6 pts (33%) had converted to CR at month 6 and month 9 after initially achieving a PR. CAR T cell expansion as measured by area under the curve in the first 28 days (AUC0-28) was over 2-fold higher in ZUMA-6 than the median observed in pts with DLBCL in ZUMA-1 (ZUMA-6: median, 823 cells/µL × days, range, 99 - 2301; ZUMA-1: median, 357 cells/µL × days, range, 5 - 11,507; Figure). Median CAR T cell levels remained higher than ZUMA-1 beyond 28 days. However, initial peak CAR T cell levels were similar (ZUMA-6: median, 68 cells/µL, range, 9 - 274; ZUMA-1: median, 32 cells/µL, range, 1 - 1513). Interferon-γ (IFNγ) levels peaked within the first week after axi-cel infusion and reached a median of 730.5 pg/mL (range, 212 - 1876). The median peak IFNγ level in pts from ZUMA-6 was 1.5-fold higher than that from pts enrolled in Cohort 1 of ZUMA-1 (493.8 pg/mL, range, 32.4 - 1876). Conclusions: PD-L1 blockade with atezo following axi-cel infusion has a manageable safety profile, with a low incidence of DLTs and no clinically significant evidence of increased incidence of AEs. Encouraging efficacy results support the opening of Phase 2 of ZUMA-6 in which 22 pts will be treated according to the Cohort 3 schedule. Pharmacokinetic data suggest the potential for enhanced CAR T cell expansion. Figure. Figure. Disclosures Locke: Kite Pharma: Other: Scientific Advisor; Novartis Pharmaceuticals: Other: Scientific Advisor; Cellular BioMedicine Group Inc.: Consultancy. Miklos:Kite - Gilead: Consultancy, Research Funding; Adaptive Biotechnologies: Consultancy, Research Funding; Pharmacyclics - Abbot: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Genentech: Research Funding; Janssen: Consultancy, Research Funding. Herrera:Merck, Inc.: Consultancy, Research Funding; Immune Design: Research Funding; Pharmacyclics: Consultancy, Research Funding; KiTE Pharma: Consultancy, Research Funding; Seattle Genetics: Research Funding; Gilead Sciences: Research Funding; AstraZeneca: Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Genentech: Consultancy, Research Funding. Westin:Apotex: Membership on an entity's Board of Directors or advisory committees; Celgen: Membership on an entity's Board of Directors or advisory committees; Novartis Pharmaceuticals Corporation: Membership on an entity's Board of Directors or advisory committees; Kite Pharma: Membership on an entity's Board of Directors or advisory committees. Lee:Kite Pharma, Caladrius Biosciences: Employment; Kite Pharma, Caladrius Biosciences: Equity Ownership; Kite Pharma: Other: TRAVEL, ACCOMMODATIONS, EXPENSES. Rossi:KITE: Employment. Zheng:Kite Pharma: Employment. Avanzi:Kite Pharma: Employment. Roberts:KITE: Employment. Sun:Kite, a Gilead Company: Employment.
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Rac, Hana, Alyssa Gould, P. Brandon Bookstaver, Julie Ann Justo, Joseph Kohn, and Majdi N. Al-Hasan. "1043. Evaluation of Early Clinical Failure Criteria for Gram-Negative Bloodstream Infections." Open Forum Infectious Diseases 5, suppl_1 (2018): S311—S312. http://dx.doi.org/10.1093/ofid/ofy210.880.
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Abstract Background Early identification of patients at high risk of morbidity and mortality following Gram-negative bloodstream infections (GN-BSI) based on initial clinical course may prompt adjustments to optimize diagnostic and treatment plans. This retrospective cohort study aims to develop early clinical failure criteria (ECFC) to predict unfavorable outcomes in patients with GN-BSI. Methods Adults with community-onset GN-BSI who survived hospitalization for at least 96 hours at Palmetto Health hospitals in Columbia, SC, USA from January 1, 2010 to June 30, 2015 were identified. Multivariate logistic regression was used to examine association between clinical variables within 72–96 hours of BSI and unfavorable outcomes (28-day mortality or hospital length of stay &gt;14 days). Results Among 766 patients with GN-BSI, 225 (29%) had unfavorable outcomes. After adjustments for Charlson Comorbidity Index and appropriateness of empirical antimicrobial therapy in multivariate model, predictors of unfavorable outcomes included systolic blood pressure &lt;100 mmHg or vasopressor use (adjusted odds ratio [aOR] 1.8, 95% confidence interval [CI] 1.1–2.5), heart rate &gt;100/minute (aOR 1.7, 95% CI 1.1–2.5), respiratory rate ≥22/minute or mechanical ventilation (aOR 2.1, 95% CI 1.4–3.3), altered mental status (aOR 4.5, 95% CI 2.8–7.1), and peripheral WBC count &gt;12 × 103/mm3 (aOR 2.7, 95% CI 1.8–4.1) at 72–96 hours from index BSI. Area under receiver operating characteristic curve of ECFC model in predicting unfavorable outcomes was 0.77 (0.84 and 0.71 in predicting 28-day mortality and prolonged hospitalization separately, respectively). Predicted 28-day mortality increased from 1% in patients with no ECFC to 3%, 7%, 16%, 32%, and 54% in presence of each additional criterion (P &lt; 0.001). Predicted hospital length of stay was 7.5 days in patients without any ECFC and increased by 4.0 days (95% CI 3.1–4.9, P &lt; 0.001) in presence of each additional criterion. Conclusion Risk of 28-day mortality or prolonged hospitalization can be estimated within 72–96 hours of GN-BSI using ECFC. These criteria may have utility in future clinical research in assessing response to antimicrobial therapy based on a standard evidence-based definition of early clinical failure. Disclosures P. B. Bookstaver, CutisPharma: Scientific Advisor, &lt;$1,000. Melinta Therapeutics: Speaker’s Bureau, &lt;$1,000.
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Lodise, Thomas, Ariel Berger, Arman Altincatal, et al. "Carbapenem-resistant Enterobacteriaceae (CRE) or Delayed Appropriate Therapy (DAT)—Does One Affect Outcomes More Than the Other Among Patients With Serious Infections Due to Enterobacteriaceae?" Open Forum Infectious Diseases 4, suppl_1 (2017): S14. http://dx.doi.org/10.1093/ofid/ofx162.034.
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Abstract Background While CRE and DAT are both associated with worse outcomes, their relative impact to the clinical and economic burden among patients with infections due to Enterobacteriaceae is not well understood. This study assessed the independent and combined effect of these two items on selected outcomes among patients with these infections. Methods Hospitalized adults between July 2011 and September 2014 were identified from Premier Hospital Database. Patients were diagnosed with complicated urinary tract infection, complicated intra-abdominal infection, hospital-associated pneumonia, or bloodstream infection, and had a positive culture for Enterobacteriaceae from a site consistent with infection type (date of culture draw was index date). Patients were required to receive antibiotics on this date or ≤2 days after. Delayed therapy was defined as no receipt of an antibiotic with microbiologic activity during this period. CRE was defined as resistant to ≥1 carbapenems. Inverse probability weighting and multivariate regression analyses were used to estimate the associations between CRE status, DAT and outcomes. Logistic models were used for composite mortality (in-hospital death or discharge to hospice), in-hospital mortality, and discharge to home (reference group was timely therapy plus non-CRE); generalized linear models, for post-index duration of antibiotic therapy, hospital length of stay (LOS), and costs. Results A total of 50,069 patients were included in the analyses; 514 had CRE and 16,414 received DAT. A gradient effect was observed across strata as the burden of serious infections was least among the reference group, and greatest among patients with CRE infection who received DAT (Figure). For example, as compared with the reference group, the risk of composite mortality increased nearly fourfold in patients with CRE infection who received DAT; total in-hospital costs more than doubled. Conclusion DAT has a stronger association than CRE on outcomes, and their effects are synergistic. Given these findings, better methods of early pathogen identification (especially organisms such as CRE) should reduce time to appropriate therapy, thereby improving outcomes in this patient population. Disclosures T. Lodise, Allergan plc: Consultant, Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium; A. Berger, Allergan plc: Consultant, Consulting fee; A. Altincatal, Evidera: Consultant, Salary; R. Wang, Evidera: Employee, Salary; T. Bhagnani, Allergan plc: Consultant, Consulting fee; P. Gillard, Allergan plc: Employee, Salary; N. G. Bonine, Allergan plc: Employee, Salary
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Vazquez, Jose A., Shawn Flanagan, Peter Pappas, George R. Thompson, Taylor Sandison, and Patrick M. Honore. "637. Outcomes by Body Mass Index (BMI) in the STRIVE Phase 2 Trial of Once-Weekly Rezafungin for Treatment of Candidemia and Invasive Candidiasis Compared with Caspofungin." Open Forum Infectious Diseases 7, Supplement_1 (2020): S378—S379. http://dx.doi.org/10.1093/ofid/ofaa439.831.
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Abstract Background There is increasing evidence of antifungal underdosing in the treatment of invasive disease, particularly in special populations such as the obese. Body size is often an important variable affecting drug exposure, and pharmacokinetic (PK) models of antifungal dosing have suggested size-based dose adjustments to achieve target drug exposure. Rezafungin (RZF) is a novel echinocandin in Phase 3 development for treatment of candidemia and invasive candidiasis (IC) and for prevention of invasive fungal disease caused by Candida, Aspergillus, and Pneumocystis in blood and marrow transplant recipients. Distinctive PK properties of RZF (e.g., long half-life, extensive tissue distribution, and front-loaded drug exposure) lend themselves to RZF once-weekly (QWk) dosing and antifungal efficacy. In this sub-analysis of the Phase 2 STRIVE trial of RZF in the treatment of candidemia and/or IC, outcomes based on patient BMI were evaluated. Methods The STRIVE trial (NCT02734862) compared the safety and efficacy of RZF QWk compared with once-daily caspofungin (Fig. 1). For this subanalysis, data were stratified by BMI categories of &lt; 30 kg/m2 and ≥ 30 kg/m2. Efficacy (overall response [resolution of clinical signs of infection + mycological eradication], mycological response, and investigator assessment of clinical response) and safety (treatment-emergent adverse events [TEAEs]) endpoints by treatment group were evaluated, as well as PK data (area under the curve [AUC]) from RZF-treated patients. Figure 1. Results Mean BMI values were similar across treatment arms (26.9 kg/m2 in RZF Group 1 and 26.8 kg/m2 in RZF Group 2 and CAS arms). Efficacy outcomes at Day 14 were similar between BMI categories (Table 1). Rates of TEAEs were generally similar between BMI categories as well (Table 2), with no concerning safety trends. Following one dose of RZF 400 mg (Week 1), the ranges of AUCs by BMI category overlapped and there was a minor mean difference of ~20% (lower for those with BMI ≥ 30 kg/m2) (Fig. 2). Table 1 Table 2 Figure 2. Conclusion The safety, efficacy, and PK of RZF in the Phase 2 STRIVE trial was consistent across BMI categories. These results suggest that dose adjustments in obese patients are not necessary. These findings contribute to the evaluation of RZF in a range of patient populations and its ongoing development. Disclosures Shawn Flanagan, PhD, Cidara Therapeutics, Inc. (Employee, Shareholder) Peter Pappas, MD, SCYNEXIS, Inc. (Consultant, Advisor or Review Panel member, Research Grant or Support) Taylor Sandison, MD, MPH, Cidara Therapeutics, Inc. (Employee, Shareholder) Patrick M. Honore, MD, PhD, FCCM, Cidara Therapeutics, Inc. (Scientific Research Study Investigator)
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Picker, Nils, Alexander T. Cohen, Anthony Maraveyas, et al. "Patient Preferences Regarding Anticoagulation Therapy in Patients with Cancer Having a VTE Event - a Discrete Choice Experiment in the Cosimo Study." Blood 134, Supplement_1 (2019): 2159. http://dx.doi.org/10.1182/blood-2019-128095.
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Introduction: Current guidelines recommend low-molecular-weight heparins (LMWH) over Vitamin K Antagonists (VKA) or Non-Vitamin K Antagonist Oral Anticoagulants (NOAC) for the treatment of cancer-associated venous thromboembolism (CAT), but also highlight that ultimately the choice of anticoagulant depends on patient-specific factors such as patient preferences, which is important for the acceptance of the treatment and, thus, for adherence and persistence. So far, little is known about the specific preferences of patients with CAT with respect to anticoagulation therapy. More specifically, the impact of dosing regimen, convenience and costs on patient preferences in CAT is poorly understood. Therefore, the objective of this discrete choice experiment (DCE) was to elucidate patient preferences regarding anticoagulation convenience attributes. Methods: Adult patients with active cancer who experienced a CAT event and for whom the decision was made to start a treatment with rivaroxaban after being treated with the standard of care anticoagulation (LMWH/VKA) for at least four weeks were included in a multinational, observational, single-arm study (COSIMO). As part of this study, a DCE was presented to the participants, who were asked to decide between complete hypothetical treatment options based on a combination of different attributes, regardless of efficacy or safety. The following attributes were preselected in a face-to-face discussion with three focus patients and in-depth interviews with four additional patients: route of administration (injection / tablet),frequency of intake (once / twice daily),need of regular controls of the International Normalized Ratio (INR) at least every 3-4 weeks (yes/no),interactions with food/alcohol (yes/no). Additionally, distance to treating physician (1 km vs. 20 km) was included as neutral comparator to express patients' overall utility in terms of a comprehensible unit. The relative importance of treatment attributes in terms of distances were calculated based on ratios between the utility estimates for each attribute. A fractional factorial design was generated resulting in nine hypothetical choice sets, supplemented by a test choice set to assess the consistency of a patient's responses. DCE data was collected by semi-structured telephone interviews, performed between week 4 and week 12 after enrollment of patients in the study and start of rivaroxaban. For each patient participating in the DCE interview, a written informed consent was obtained. Patient preferences were analyzed based on a conditional logit regression model. Results: Overall, 163 patients were included (Europe: 119; Canada: 41; Australia: 3), mean age 63.7 years, 49.1% were females and diagnosed with cancer for on average 22.4 months. Most patients in the COSIMO study changed to rivaroxaban from LMWH (> 95.0 %). The median time from diagnosis of index CAT event to conduct of DCE was 150 days (IQR 88-229). Patients strongly preferred oral administration compared to self-injections and drugs that can be taken irrespective of type of food or alcohol consumption (Figure 1). Furthermore, patients indicated slight preference for a shorter distance to the treating physician and a once daily dosing regimen compared to a twice-daily intake. The attribute "INR controls" showed no significant impact on the treatment decision. In order of patients' preference for their choice of treatment, the route of administration was by far the most important attribute for a patient's choice (73.8% of the overall decision), followed by food interactions (11.8%), the distance to treating physician (7.2%) and the intake frequency (6.5%). Accordingly, the expected utility of patients receiving an oral anticoagulation can be expressed as willingness to travel an additional distance of 192 km to the treating physician in order to avoid an injection. Conclusions Treatment related decision-making of patients with CAT, assuming equal effectiveness and safety of treatments, is predominantly driven by "route of administration", indicating a strong preference for oral intake. Disclosures Picker: Ingress-Health: Employment. Cohen:Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; ACI Clinical: Consultancy; GLG: Consultancy; GlaxoSmithKline: Consultancy, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CSL Behring: Consultancy; Boston Scientific: Consultancy; AbbVie: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Aspen: Consultancy, Speakers Bureau; Guidepoint Global: Consultancy; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Medscape: Consultancy, Speakers Bureau; McKinsey: Consultancy; Navigant: Consultancy; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Consultancy; Temasek Capital: Consultancy; TRN: Consultancy; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism. Maraveyas:Bayer AG: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria; Pfizer: Honoraria. Beyer-Westendorf:Pfizer: Honoraria, Research Funding; Bayer HealthCare: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding; Daiichi Sankyo: Honoraria, Research Funding. Lee:Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria; LEO Pharma: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria. Mantovani:Fondazione Charta: Consultancy; Bayer AG: Honoraria; Boehringer Ingelheim: Honoraria, Research Funding; Pfizer: Honoraria; Daiichi Sankyo: Research Funding. De Sanctis:Bayer US LLC: Employment, Equity Ownership. Abdelgawwad:Bayer AG: Employment. Fatoba:Bayer AG: Employment. Bach:Bayer AG: Employment. Wilke:Astra Zeneca: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Novo Nordisk: Consultancy, Honoraria; Pharmerit: Consultancy, Honoraria; Bayer AG: Consultancy, Honoraria; LEO Pharma: Consultancy, Honoraria; GlaxoSmithKline: Consultancy, Honoraria; Merck: Consultancy, Honoraria; Boehringer Ingelheim: Consultancy, Honoraria.
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Wang, Michael L., Javier Munoz, Andre Goy, et al. "KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Patients (Pts) With Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Results of the Phase 2 ZUMA-2 Study." Blood 134, Supplement_1 (2019): 754. http://dx.doi.org/10.1182/blood-2019-126064.
Full textAbstract:
Background: Outcomes with salvage regimens in pts with MCL who progress after Bruton tyrosine kinase inhibitor (BTKi) therapy are poor, with a median overall survival (OS) of 5.8 months (Martin, et al. Blood. 2016) and few pts proceeding to allogeneic stem cell transplant. ZUMA-2 is a Phase 2, registrational, multicenter, global study evaluating KTE-X19, an autologous anti-CD19 CAR T cell therapy, in pts with R/R MCL who received 1-5 prior therapies, including a BTKi. Here, we present interim efficacy and safety results from ZUMA-2. Methods: Eligible adults (aged ≥ 18 years) with R/R MCL had an ECOG score of 0 - 1 and ≤ 5 prior therapies, including chemotherapy, an anti-CD20 antibody, and a BTKi. Pts underwent leukapheresis and conditioning chemotherapy (cyclophosphamide 300 mg/m2/d and fludarabine 30 mg/m2/d for 3 days) followed by a single infusion of KTE-X19 at a target dose of 2 × 106 CAR T cells/kg. Pts could have received bridging therapy with dexamethasone, ibrutinib, or acalabrutinib after leukapheresis and before conditioning chemotherapy at the investigator's discretion. The primary endpoint was objective response rate (ORR [complete response (CR) + partial response]) assessed by an Independent Review Committee according to the Lugano Classification (Cheson, et al. J Clin Oncol. 2014). Interim efficacy endpoints were investigator-assessed using the revised IWG Response Criteria for Malignant Lymphoma (Cheson, et al. J Clin Oncol. 2007). Key secondary endpoints were duration of response (DOR), progression-free survival (PFS), OS, frequency of adverse events (AEs), levels of CAR T cells in blood, and levels of cytokines in serum. Efficacy and safety analyses included all pts who received KTE-X19. A total of 60 pts received KTE-X19; here, we present results in pts who had ≥ 1 year of follow-up. Updated safety and efficacy results in the full 60 pts, including pts who received revised AE management with the aim of decreasing toxicity, will be reported in the presentation. Results: As of May 30, 2018, 28 pts received KTE-X19 with ≥ 1 year of follow-up (median 13.2 months [range, 11.5 - 18.5]). The median age was 65 years (range, 50 - 75) and 86% of pts were male. Forty-three percent of pts had ECOG score of 1, 21% had blastoid morphology, 82% had stage IV disease, 50% had intermediate/high-risk MIPI, 86% received a median of 4 (range, 1 - 5) prior therapies, and 57% were refractory to last prior therapy. In 20/28 pts with available data, the median Ki-67 index was 38% (range, 5% - 80%). Eight pts received bridging therapy; all had disease present post-bridging. Investigator-assessed ORR was 86% (95% CI, 67% - 96%) with a CR rate of 57% (95% CI, 37% - 76%). As of May 30, 2018, 75% of responders remained in response and 64% of treated pts had ongoing responses. The 12-month estimates of DOR, PFS and OS were 83% (95% CI, 60% - 93%), 71% (95% CI, 50% - 84%), and 86% (95% CI, 66% - 94%), respectively and the medians were not reached. The most common Grade ≥ 3 AEs (≥ 20% of pts) were anemia (54%), platelet count decreased (39%), neutropenia (36%), neutrophil count decreased (32%), white blood cell count decreased (29%), encephalopathy (25%), and hypertension (21%). Grade 3/4 cytokine release syndrome (CRS) assessed by Lee et al. (Blood. 2014) was reported in 18% of pts, most commonly manifesting as hypotension (14%), hypoxia (14%), and pyrexia (11%). Grade 3/4 neurologic events (NE) were reported in 46% of pts and included encephalopathy (25%), confusional state (14%), and aphasia (11%). No Grade 5 CRS or NE occurred. All CRS events and most NE (15/17 pts) were reversible. Median time to onset and resolution of CRS was 2 days (range, 1 - 7) and 13 days (range, 4 - 60), respectively. Median time to onset of NE was 6 days (range, 1 - 15) and median time to resolution was 20 days (range, 9 - 99). There was 1 Grade 5 AE of organizing pneumonia that was considered related to conditioning chemotherapy. Median CAR T cell levels as measured by peak and area under the curve were 99 cells/µL (range, 0.4 - 2589) and 1542 cells/µL (range, 5.5 - 27239), respectively. Peak CAR T cell expansion was observed between Days 8 and 15 and declined over time. Conclusions: ZUMA-2 is the first multicenter Phase 2 study of CAR T cell therapy in pts with R/R MCL. With ≥ 1 year of follow-up, KTE-X19 demonstrated significant and durable clinical benefit, including a majority of pts achieving CR, and a manageable safety profile in pts with R/R MCL for whom there are no curative treatment options. Disclosures Wang: VelosBio: Research Funding; Guidepoint Global: Consultancy; BioInvent: Consultancy, Research Funding; Kite Pharma: Consultancy, Research Funding; Acerta Pharma: Consultancy, Research Funding; MoreHealth: Consultancy, Equity Ownership; AstraZeneca: Consultancy, Honoraria, Research Funding, Speakers Bureau; Pharmacyclics: Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Loxo Oncology: Research Funding; Celgene: Honoraria, Research Funding; Juno Therapeutics: Research Funding; Aviara: Research Funding; Dava Oncology: Honoraria. Munoz:Pharmacyclics /Janssen: Consultancy, Research Funding, Speakers Bureau; Bayer: Consultancy, Speakers Bureau; Merck: Consultancy; Kyowa: Consultancy, Honoraria, Speakers Bureau; Seattle Genetics: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene/Juno: Consultancy, Research Funding; Genentech: Consultancy, Research Funding, Speakers Bureau; Kite/Gilead: Consultancy, Research Funding, Speakers Bureau; Bristol-Myers Squibb: Consultancy; Alexion: Consultancy; Pfizer: Consultancy; Fosunkite: Speakers Bureau; AstraZeneca: Speakers Bureau; Portola: Research Funding; Incyte: Research Funding. Goy:Astrazenca: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; University of Nebraska: Research Funding; Hakensackumc: Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Hackensack University Medical Center, RCCA: Employment; COTA: Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Other: leadership role for profit healthcare company; Genentech: Other: Grants outside of the submitted work, Research Funding; Pharmacyclics/Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants outside of the submitted work, Research Funding; Kite, a Gilead Company: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants outside of the submitted work; Takeda: Other: Grants outside of the submitted work; Acerta: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants outside of the submitted work, Research Funding. Locke:Kite: Other: Scientific Advisor; Novartis: Other: Scientific Advisor; Cellular BioMedicine Group Inc.: Consultancy. Jacobson:Humanigen: Consultancy, Other: travel support; Novartis: Consultancy, Honoraria, Other: travel support; Bayer: Consultancy, Other: travel support; Precision Biosciences: Consultancy, Other: travel support; Kite, a Gilead Company: Consultancy, Honoraria, Other: travel support; Celgene: Consultancy, Other: travel support; Pfizer: Research Funding. Hill:Amgen: Research Funding; Pharmacyclics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Kite: Consultancy, Honoraria; Genentech: Consultancy, Research Funding; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; TG therapeutics: Research Funding; Takeda: Research Funding; AstraZeneca: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Celegene: Consultancy, Honoraria, Research Funding. Timmerman:Spectrum Pharmaceuticals: Research Funding; Kite, A Gilead Company: Consultancy, Honoraria, Other: travel support, Research Funding; Merck: Research Funding; ImmunGene: Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Other: travel support, Research Funding. Holmes:ADC Therapeutics: Research Funding; Kite, A Gilead Company: Consultancy, Speakers Bureau; Genentech: Research Funding; Janssen: Consultancy; Rigel: Consultancy, Speakers Bureau; Bayer: Consultancy; Novartis: Research Funding; Unum: Research Funding; Gilead: Consultancy; Juno: Consultancy; Seattle Genetics: Research Funding, Speakers Bureau. Jaglowski:Kite: Consultancy, Other: advisory board, Research Funding; Unum Therapeutics Inc.: Research Funding; Juno: Consultancy, Other: advisory board; Novartis: Consultancy, Other: advisory board, Research Funding. Flinn:TG Therapeutics, Trillum Therapeutics, Abbvie, ArQule, BeiGene, Curis, FORMA Therapeutics, Forty Seven, Merck, Pfizer, Takeda, Teva, Verastem, Gilead Sciences, Astra Zeneca (AZ), Juno Therapeutics, UnumTherapeutics, MorphoSys, AG: Research Funding; Acerta Pharma, Agios, Calithera Biosciences, Celgene, Constellation Pharmaceuticals, Genentech, Gilead Sciences, Incyte, Infinity Pharmaceuticals, Janssen, Karyopharm Therapeutics, Kite Pharma, Novartis, Pharmacyclics, Portola Pharmaceuticals: Research Funding; AbbVie, Seattle Genetics, TG Therapeutics, Verastem: Consultancy; TG Therapeutics, Trillum Therapeutics, Abbvie, ArQule, BeiGene, Curis, FORMA Therapeutics, Forty Seven, Merck, Pfizer, Takeda, Teva, Verastem, Gilead Sciences, Astra Zeneca (AZ), Juno Therapeutics, UnumTherapeutics, MorphoSys, AG: Research Funding; F. Hoffmann-La Roche Ltd: Research Funding. McSweeney:Fred Hutchinson Cancer Research Center: Patents & Royalties; Colorado Blood Cancer Institute Medical Group: Employment; Kite, a Gilead Company: Consultancy, Honoraria, Research Funding, Speakers Bureau. Miklos:AlloGene: Consultancy; Janssen: Consultancy; Pharmacyclics: Consultancy, Patents & Royalties, Research Funding; Kite, A Gilead Company: Consultancy, Research Funding; Celgene-Juno: Consultancy; Novartis: Consultancy; Miltenyi: Consultancy, Research Funding; Adaptive Biotechnologies: Consultancy, Research Funding; Becton Dickinson: Consultancy; Precision Bioscience: Consultancy. Pagel:Gilead Sciences: Consultancy; Pharmacyclics: Consultancy; AstraZeneca: Consultancy. Kersten:Amgen: Other: Travel grants, honorarium, or advisory boards; Roche: Other: Travel grants, honorarium, or advisory boards; Janssen/Cilag: Other: Travel grants, honorarium, or advisory boards; Roche: Consultancy, Research Funding, Travel grants, honorarium, or advisory boards; Celgene: Other: Travel grants, honorarium, or advisory boards; Celgene: Consultancy, Research Funding; Bristol Myers Squibb: Other: Travel grants, honorarium, or advisory boards; MSD: Other: Travel grants, honorarium, or advisory boards; Takeda: Consultancy, Research Funding; Gilead: Other: Travel grants, honorarium, or advisory boards; Kite: Consultancy, Other: Travel grants, honorarium, or advisory boards; Novartis: Consultancy, Other: Travel grants, honorarium, or advisory boards. Peng:Kite, A Gilead Company: Employment. Rossi:Kite, A Gilead Company: Employment. Jain:Vida Ventures: Employment; Kite, A Gilead Company: Employment, Equity Ownership, Other: Travel support; Amgen: Equity Ownership. Rao:Kite, A Gilead Company: Employment. Reagan:Kite, A Gilead Company: Consultancy; Curis: Consultancy; Seattle Genetics: Research Funding. OffLabel Disclosure: ZUMA-2 is a clinical trial evaluating KTE-X19, an investigational CAR T cell therapy
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Khanna, Sahil, Ken Blount, Courtney Jones, Bill Shannon, and Sharina Carter. "Successful Response to Microbiota-Based Drug RBX2660 in Patients with Recurrent Clostridium Difficile Infection is Associated with More Pronounced Alterations in Microbiome Profile." Open Forum Infectious Diseases 4, suppl_1 (2017): S387. http://dx.doi.org/10.1093/ofid/ofx163.963.
Full textAbstract:
Abstract Background Recurrent Clostridium difficile infections (rCDI) are associated with decreased diversity and altered intestinal microbiome compared with healthy patients. RBX2660, a standardized microbiota-based drug, is designed to restore microbiome diversity and composition in patients’. The effect of RBX2660 on rCDI patient microbiomes was evaluated by comparing pre- and post-treatment samples from PUNCH CD 2—a randomized, double-blind, placebo-controlled study. Methods rCDIsubjects were randomized to receive blinded treatments of 2 doses of RBX2660 (Group A), 2 doses of placebo (Group B), or 1 dose each of RBX2660 and placebo (Group C), by enema 7 days apart. Subjects submitted stool samples at baseline, day 7, 30, and 60 after treatment. Stool samples from responders to RBX2660 treatment per protocol defined as the absence of CDI for 8 weeks after treatment were compared with non-responders. Relative taxonomic abundances at the class level were determined using 16s rRNA sequencing analysis for 94 stool samples from 45 patients in Groups A and C. Relative abundance data were grouped longitudinally using Bray-Curtis dissimilarity index. Analyses were performed based on the Dirichlet-Multinomial distribution to compare group mean relative taxonomic abundances; Simpson and Shannon diversity indices were compared among groups longitudinally. Results Baseline patient microbiomes were similar across response groups. RBX2660 treatment shifted the relative microbiome densities with taxa-specific increase in Bacteroidia, Clostridia, and decrease in Gamma-proteobacteria abundance. A larger shift from baseline microbiome was seen in responders to RBX2600 compared with non-responders (Figure 1). Microbiome changes in responders were durable to 60 days. RBX2660 treatment increased Shannon and Simpson diversity at 7 days post-treatment in responders but not in non-responders (P &lt; 0.05). Conclusion RBX2660 treatment shifts patient intestinal microbiomes with greater alterations seen in those with a successful clinical outcome. Funded by Rebiotix Inc., Roseville, MN. Disclosures S. Khanna, Rebiotix, Inc.: Scientific Advisor, Consulting fee; K. Blount, Rebiotix, Inc.: Employee, Salary; C. Jones, Rebiotix, Inc.: Employee, Salary; B. Shannon, Rebiotix, Inc.: Research Contractor, Consulting fee; S. Carter, Rebiotix, Inc.: Research Contractor, Consulting fee
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Sidorenko, Alexandre, and Asghar Zaidi. "International Policy Frameworks on Ageing: Assessing Progress in Reference to the Madrid International Plan of Action on Ageing." Journal of Social Policy Studies 16, no. 1 (2018): 141–54. http://dx.doi.org/10.17323/727-0634-2018-16-1-141-154.
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Alexandre Sidorenko – Senior Advisor, European Centre for Social Welfare Policy and Research, Vienna, Austria. Email: sidorenko.alexandre@gmail.com
 Asghar Zaidi – Professor in International Social Policy, University of Southampton, UK. Email: Asghar.Zaidi@soton.ac.uk
 The central goal of this article is to review progress made in implementing the international policy frameworks on ageing, focusing on the Vienna International Plan of Action on Ageing (VIPAA) and in more detail on the Madrid International Plan of Action on Ageing (MIPAA). The article offers a critical examination of the current approaches to monitoring and assessing the implementation process, outlining promising avenues for the future. In this way, the limitations of the current procedures for following the policy priorities of the MIPAA can be highlighted. What is found is that progress in many countries is hampered by inherent subjectivity in assessing and reporting advancement, lack of continuity and consistency, and difficulties in comparing the national level progress with international development in the same areas. The current year, 2017 / 2018, is momentous as we reach the end of the third five-year implementation cycle of the MIPAA. Introspection now should not merely focus on assessing the progress made but also on how the implementation of the MIPAA could be strengthened. In the same spirit, the 2030 Agenda of Sustainable Development Goals presents new opportunities; especially its pledges 'Leave no one behind' and 'Reach the furthest behind first', which imply that the older population can serve as agents of development. In moving forward, an essential requirement will have to be the establishment of an internationally acceptable set of indicators, which can be employed for assessing national progress in addressing the challenges and opportunities of ageing and monitoring the international efforts to implement international policy frameworks like the MIPAA. Along the lines of the dashboard of indicators used in the Active Ageing Index 'AAI', there should be a MIPAA monitoring toolkit with different layers of indicators, which are aligned with the three priority directions of the MIPAA.
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A., Jimoh, Salawu A., Yusuf A., and Folorunso I. "INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) COMPETENCY OF SERVING TEACHERS FOR QUALITYINSTRUCTIONAL SERVICE DELIVERY IN AMINU SALEH COLLEGE OF EDUCATION, AZARE, BAUCHI STATE, NIGERIA." Education and Science Journal of Policy Review and Curriculum Development 10, no. 1 (2021): 38–55. http://dx.doi.org/10.48028/iiprds/esjprcd.v10.i1.04.
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ICT has permeated all spheres of human endeavours in this 21st century of information-driven society, education sector inclusive. Consequence upon this development, teachers as stakeholders are not left behind in the aspect of training and retraining to acquire relevant skills in the usage of ICT in order to be ICT-compliant and use same in their teaching methodologies. This paper, therefore, examined ICT competency of serving teachers for quality instructional service delivery in Aminu Saleh College of Education, Azare, Bauchi State, Nigeria. The study adopted survey research design as questionnaire was used as an instrument for data collection from the sampled serving teachers. The questionnaire used for this research was structured on three components of ICT: Microsoft PowerPoint Presentation, Internet Usage and Usage of projector/interactive multimedia board. Simple random sampling technique was used to draw sample of 196 from the population of entire academics totally 436 currently serving in the area of the study using sample size table provided by Research Advisor. The instrument used for the study was validated by the specialists in the fields of Computer Science and Measurement and Evaluation. The reliability index of the instrument yielded 0.82 using Crobanch alpha reliability technique. The results revealed that academics have skills in the usage of Microsoft PowerPoint Presentation for effective instructional service delivery. Besides, it was found out that the serving teachers possess technical-know-how in Internet usage for gathering materials for their lessons, but lack skills on how to operate projector/interactive multimedia board for their lectures. It was also discovered that age, gender and years of experience had significant influence on the level of ICT skills acquisition and usage of serving teachers. However, there was no association between educational qualification of serving teachers and their level of ICT skills acquisition. The study recommends that Bauchi state government, in conjunction with College authority, should organize seminar on how to use and operate projector as well as interactive multimedia board for quality instructional service delivery by the lecturers.
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Zhu, Xufeng. "Government Advisors or Public Advocates? Roles of Think Tanks in China from the Perspective of Regional Variations." China Quarterly 207 (September 2011): 668–86. http://dx.doi.org/10.1017/s0305741011000701.
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AbstractThink tanks in China simultaneously play advisory, academic and advocacy roles in the policy process. In this article, I recommend an analytical framework that evaluates think tanks by studying their specific activities in addition to their nature. Empirical data involving 301 think tanks in 25 provinces were collected through the China Think Tank Survey 2004. The 1998 regional Integrated Knowledge Development Index database was also used for the analysis. Based on these two independent sets of survey data, the article concludes that connections with the government and knowledge capacity in regions where think tanks are located are the two differing forces that drive China's think tanks to operate as either advisors or advocates. Moreover, these two determinants differentially influence the individual roles of the two types of think tanks.
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Fonseca, Rafael, May Hagiwara, Sumeet Panjabi, Emre Yucel, Jacqueline Buchanan, and Thomas Delea. "Economic Burden of Disease Progression Among Transplant Eligible Multiple Myeloma Patients Who Have Received at Least One Line of Therapy in the US." Blood 134, Supplement_1 (2019): 2211. http://dx.doi.org/10.1182/blood-2019-123743.
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Introduction Data on the economic burden of disease progression among multiple myeloma (MM) patients who have had a stem cell transplant (SCT) in the US are limited. This study evaluated the impact of disease progression on healthcare resource utilization (HRU) and costs among these patients in the US. Methods Adult patients (pts) with a confirmed MM diagnosis (Dx), defined as ≥1 inpatient or ≥2 non-diagnostic outpatient claims 30-365 days apart who initiated a course of MM therapy (Rx) during the study period (Jan 1, 2006 to Dec 31, 2016) and received SCT during the first year after the initial diagnosis of MM were identified from the Truven Analytics MedStat MarketScan® Commercial Claims and Encounters and Medicare and Coordination of Benefits databases. The first date with Dx for MM was defined as the "Dx date" and line of therapy (LOT) was identified based on an adaptation of a previously-developed algorithm. Pts were excluded if they had a gap in enrollment during the period beginning 6-month before the Dx date through 30-days after the first LOT (1L) initiation date, received MM Rx, unclassified antineoplastic medications, or SCT before the Dx date, or had missing information required to identify LOT or assess baseline characteristics or study outcomes. The 12 months after initiation of each LOT was designated the "event identification period" for progression. Disease progression was defined as advancement to next LOT, diagnosis or procedure codes indicative of bone metastasis, hypercalcemia, soft tissue plasmacytoma, skeletal related events, or acute kidney disease while off MM Rx, or death. The "event date" for progression was defined as date with evidence of progression. For each pt with progression, one pt without progression was randomly selected and assigned an event date to ensure that the distribution of time from LOT initiation to event date for pts without progression was the same as the distribution of time from LOT initiation to event date for pts with progression. For each LOT (L1-L3), annual HCRU and costs from index date, defined as 30-day before the event date, through disenrollment or end of the study period were compared for pts with vs without progression using inverse probability of treatment weighting (IPTW) to adjust for differences between groups in baseline characteristics including year of index date, age, gender, region, plan type, Medicare status, comorbidities, and pre-index HRU and healthcare costs. All costs were adjusted to 2016 US $. In a subgroup analysis, HCRU and costs were evaluated for LOTs initiated from 2013 to 2016 to reflect patterns of treatment in current era. Results Of the 28,184 adult MM pts who received ≥1 MM Rx during the study period, 3226 qualified for the study, including 837 pts with progression and 2389 without progression during 1L. The corresponding numbers for 2L, and 3L were 412 and 589, and 226 and 196, respectively. Mean age at index date was 57 years; 57% were male. After IPTW, all baseline characteristics were well balanced in all LOTs with standardized mean differences <0.1 for most baseline characteristics. The mean number of hospitalizations per year was greater for pts with progression in all LOTs, with differences ranging from 1.11 (95%CI 0.85, 1.37) for 2L to 0.34 (95%CI 0.21, 0.47) for 1L. In all LOTs, annual costs of inpatient and outpatient services were greater for pts with progression while costs of outpatient prescriptions were greater among patient without progression. Total healthcare costs were greater for pts with vs without progression in all LOTs with hospitalizations and outpatient visit costs being key drivers. Total incremental annual costs in those who progressed were higher by $13,386 (1L), $105,004 (2L), and $70,206 (3L). When the analysis was restricted to LOTs initiated between 2013 and 2016, the incremental costs in pts who progressed were generally greater in the most recent era: $43,381 (1L), $113,797 (2L), and $115,327 (3L). Conclusions For MM pts receiving drug Rx and SCT the economic burden of disease progression is substantial across all LOTs. Incremental costs of progression are largely attributable to hospitalizations and outpatient visits. Treatments that prevent or delay progression are likely to yield important reductions in downstream disease management costs. These savings should be considered in frameworks assessing the value of innovative treatments for MM. Disclosures Fonseca: AbbVie, Amgen, Bayer, Celgene, Kite, Janssen, Juno, Merck, Pharmacylics, Sanofi, Takeda: Other: Consultant/Advisor; Prognosticatin of MM based on Genetic Categorization by FISH: Patents & Royalties; Adaptive Biotechnologies: Other: Scientific Advisory Board. Hagiwara:Amgen Inc.: Research Funding. Panjabi:Amgen Inc.: Employment, Other: Owns Amgen stock, Research Funding. Yucel:Amgen Inc.: Employment, Other: Owns Amgen stock, Research Funding. Buchanan:Amgen Inc.: Employment, Other: Owns Amgen stock, Research Funding. Delea:Amgen Inc.: Research Funding.
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Harper, Kristine C. "Brian Austin. Schonland, Scientist and Soldier: From Lightning on the Veld to Nuclear Power at Harwell: The Life of Field Marshal Montgomery’s Scientific Advisor. Foreword by, Sir Maurice Wilkes. 639 pp., notes, index. Bristol, U.K.: Institute of Physics Publishing, 2001." Isis 95, no. 4 (2004): 709. http://dx.doi.org/10.1086/432310.
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Abraham, Katharine G., John S. Greenlees, and Brent R. Moulton. "Working to Improve the Consumer Price Index." Journal of Economic Perspectives 12, no. 1 (1998): 27–36. http://dx.doi.org/10.1257/jep.12.1.27.
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In this paper, we first comment on the recent (1996) report of the Advisory Commission to Study the Consumer Price Index, appointed by the U.S. Senate Finance Committee, and the recommendations it contains. We then describe some of the initiatives currently underway at the Bureau of Labor Statistics—some of which were undertaken before the appearance of the Advisory Commission's report, others of which are part of a Consumer Price Index improvement initiative that was included as part of the President's 1998 budget proposal—which attempted to address the bias issues that were highlighted by the Advisory Commission.
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Choe, Hannah, Nirav N. Shah, Patrice Chevallier, et al. "A Single-Arm, Open-Label Phase 1 Study of Itacitinib (ITA) with Calcineurin Inhibitor (CNI)-Based Interventions for Prophylaxis of Graft-Versus-Host Disease (GVHD; GRAVITAS-119)." Blood 136, Supplement 1 (2020): 50–51. http://dx.doi.org/10.1182/blood-2020-140747.
Full textAbstract:
Background Despite prophylaxis, GVHD remains a significant cause of morbidity and nonrelapse mortality after allogeneic hematopoietic cell transplantation (HCT). ITA is a potent, selective Janus kinase (JAK) 1 inhibitor that has been combined safely with steroids in patients (pts) with acute GVHD. We describe results from a proof-of-concept study evaluating ITA + CNI-based regimens for GVHD prophylaxis. Study Design and Methods GRAVITAS-119 (NCT03320642) was a single-arm, open-label study enrolling pts aged ≥18 y undergoing allogeneic HCT using peripheral blood stem cells from 8/8 or 7/8 matched related or unrelated donors for a hematologic malignancy. Eligible pts were candidates for reduced-intensity conditioning with Karnofsky Performance Status ≥70%. Pts were excluded for prior HCT, JAK inhibitor therapy, or active uncontrolled infection. Pts received oral ITA 200 mg once daily (QD) beginning 3 d before HCT + tacrolimus (Tac)/methotrexate (MTX) or cyclosporine A (CSA)/mycophenolate mofetil (MMF) ± antithymocyte globulin (ATG) per institutional practice. ITA dose reduction/interruption was permitted for toxicity. ITA was reduced to 100 mg QD by Day 90 and discontinued by Day 180 unless pts required systemic GVHD treatment (tx), had malignancy relapse or unacceptable toxicity, or withdrew consent. The primary endpoint was Day 28 hematologic recovery (absolute neutrophil count [ANC] ≥500/mm3 for 3 consecutive measurements and platelets [plt] ≥20,000/mm3 with no transfusions in the preceding 3 d). Secondary endpoints included incidence of acute and chronic GVHD, GVHD- and relapse-free survival (GRFS), overall survival, and safety. Results Sixty-five pts were enrolled and treated with ITA + Tac/MTX (n=41; +ATG, n=8; no ATG, n=33) or ITA + CSA/MMF (n=24; +ATG, n=16; no ATG, n=8). Median (range) age was 65 (25-76) y, and 57% were male. The most common underlying malignancies were acute myeloid leukemia (40%) and myelodysplastic syndrome (26%). Disease risk index was classified as low, intermediate, and high in 11%, 66%, and 23% of pts, respectively. Pts received grafts from matched related (51%), matched unrelated (40%), or single-antigen mismatched unrelated (9%) donors. Busulfan/fludarabine (51%) and a fludarabine/melphalan reduced-intensity regimen (18%) were the most common conditioning regimens; 11% of regimens contained total body irradiation. Median (range) exposure to ITA was 140 (10-187) d; 74% received ITA for &gt;90 d. All pts achieved hematologic recovery. Median (range) time to ANC and plt recovery among patients who had count nadir (ANC &lt;500/mm3 and/or plt &lt;20,000/mm3) was 17 (4-31) and 14 (9-26) d, respectively. ANC recovery was on Day 31 for 1 pt with secondary myelofibrosis (MF). Two pts had secondary graft failure, 1 on tx (Tac/MTX/ATG; Day 65), with no evidence of viral infection, and 1 during post-tx follow-up (Tac/MTX; Day 182); both underwent retransplantation. Malignancy relapse (median follow-up, 363 d) occurred in 12 pts (18%), including 3 pts with molecular/cytogenetic relapse requiring intervention. In 63 evaluable pts, cumulative incidence of grade III/IV acute GVHD at Day 180 was 4.8% and 1-y GRFS was 38.5%. Secondary efficacy endpoints by tx group are in Table 1. The most common grade 3/4 hematologic adverse events (AEs) were thrombocytopenia (49%) and anemia (31%). 17 pts (26%) had cytomegalovirus reactivations (n=10 +ATG), 8 (12%) had Epstein-Barr virus (EBV) infection (no post-transplant lymphoproliferative disorder cases; all +ATG), and 1 pt (2%) had invasive bronchopulmonary aspergillosis (Tac/MTX +ATG). AEs (22%) and relapse (17%) were the most common reasons for ITA discontinuation; the most common AEs leading to discontinuation were mixed chimerism (6%), thrombocytopenia (3%), and hypertriglyceridemia (3%). 8 pts in the +ATG group received post-transplant rituximab for EBV infection (n=7) and/or azaciditine maintenance therapy (n=3). 15 pts (24%) in the per-protocol population died. 3 deaths occurred on tx due to infections (n=2) and intracranial hemorrhage (n=1; Table 2). Conclusions Results from this small open-label trial in a heterogeneous pt population demonstrated that GVHD prophylaxis with ITA + CNI-based regimens was well tolerated and rates of severe acute GVHD were low. 1 pt with MF did not achieve ANC recovery on Day 28. An ITA + Tac + post-transplant cyclophosphamide cohort is currently being investigated in GRAVITAS-119. Disclosures Shah: Cell Vault: Research Funding; Celgene: Consultancy, Honoraria; Miltenyi Biotec: Honoraria, Research Funding; Kite Pharma: Consultancy, Honoraria; Incyte: Consultancy; TG Therapeutics: Consultancy; Verastim: Consultancy; Lily: Consultancy, Honoraria. Chevallier:Incyte Corporation: Honoraria. Rubio:Medac: Consultancy; MSD: Honoraria; Gilead: Honoraria; Neovii: Research Funding; Novartis: Honoraria. Schroeder:Astellas: Other; Dova Pharmaceuticals: Other; FlatIron Inc: Other; GSK: Other; Gilead Sciences Inc: Other; Novo Nordisk: Other; Genentech Inc: Research Funding; Merck: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Speakers Bureau; Incyte Corporation: Other: served on advisory boards and received honoraria or consultant fees, Research Funding; Cellect Inc: Research Funding; Janssen: Research Funding; Partners Therapeutics: Other; Pfizer: Other; AbbVie: Consultancy, Honoraria, Speakers Bureau; Fortis: Research Funding; Seattle Genetics: Research Funding; Amgen: Other: served on advisory boards and received honoraria or consultant fees, Research Funding; Celgene: Research Funding; PBD Incorporated: Research Funding; Genzyme Sanofi: Other: served on advisory boards and received honoraria or consultant fees, Research Funding. Hardy:Incyte Corporation: Other: Advisory Board Member; Kite/Gilead: Other: Advisory Board Member; American Gene Technologies: Other: DSMB Member. Stiff:Kite, a Gilead Company: Research Funding; Amgen: Research Funding; Gamida Cell: Research Funding; Atara: Research Funding; Unum: Research Funding; Delta-Fly: Research Funding; Macrogenics: Research Funding. Solano:Incyte Corporation: Other: Received fees for an advisory role. Yakoub-Agha:Celgene: Honoraria; Novartis: Honoraria; Gilead/Kite: Honoraria, Other: travel support; Janssen: Honoraria; Jazz Pharmaceuticals: Honoraria. Rowley:AbbVie: Current equity holder in publicly-traded company; FATE Therapeutics: Consultancy. Duarte:Incyte Corporation: Other: Has received speaker and advisor fees. Morariu-Zamfir:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Arbushites:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Ding:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Perales:Miltenyi Biotec: Research Funding; Kite/Gilead: Honoraria, Research Funding; Incyte Corporation: Honoraria, Research Funding; Nektar Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Cidara Therapeutics: Other; Servier: Membership on an entity's Board of Directors or advisory committees, Other; NexImmune: Membership on an entity's Board of Directors or advisory committees; Medigene: Membership on an entity's Board of Directors or advisory committees, Other; Omeros: Honoraria, Membership on an entity's Board of Directors or advisory committees; MolMed: Membership on an entity's Board of Directors or advisory committees; Bellicum: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Merck: Consultancy, Honoraria; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria. OffLabel Disclosure: Itacitinib is a novel JAK1 inhibitor that has not been approved for use in acute GVHD or for any other indication.