Artykuły w czasopismach: „Consulting”

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Dib, Rita Wilson, Xiqi Li, Samuel Shelburne, Anne-Marie Chaftari, Ray Y. Hachem, Ruth Reitzel, Nylev Vargas-Cruz, Thomas L. Holland, Vance G. Fowler i Issam Raad. "1036. Whole Genome Sequencing Analysis of a Large Cohort of Staphylococcus epidermidis Blood Culture Positive Isolates From a Multicenter Clinical Trial". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S309—S310. http://dx.doi.org/10.1093/ofid/ofy210.873.

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Abstract Background Staphylococcus epidermidis is a leading cause of healthcare-associated bacteremia, but the clinical course of S. epidermidis isolated from blood cultures ranges from contamination to serious deep seated infections. We tested the hypothesis that the genetic characteristics of S. epidermidis isolated from blood cultures are significantly associated with disease severity using whole genome sequencing (WGS). Methods We performed WGS of 163 S. epidermidis isolates from a large prospective multicenter, randomized control trial that assessed the safety and efficacy of algorithm-based treatment of patients with staphylococcal bacteremia (ClinicalTrials.gov #NCT01191840). Patient’s infection types were divided into simple (including possible contamination), uncomplicated and complicated bacteremia. Failure was defined as persistent signs and symptoms of infection at 72 hours, persistent bacteremia at 7 days, relapse, complications or overall mortality within 28 days of therapy. WGS was performed using Illumina Miseq, followed by in silico multi-locus sequence type identification and phylogenomic analysis using kSNP. Results Of the 163 isolates analyzed, 39 sequence types (STs) were identified with ST2 and ST5 isolates being most frequently identified (21% and 20%, respectively). ST2 and ST5 isolates were significantly more likely associated with uncomplicated and complicated infections rather than simple bacteremia (P = 0.01 by χ2 test). By multivariate regression analysis, having an ST2 or ST5 S. epidermidis bacteremia was an independent predictor of a complicated infection (odds ratio 4.28, 95% CI 1.36–13.42). Using WGS based branching points rather than sequence typing allowed for additional strengthening of the association of S. epidermidis genetic clustering and clinical infection types (figure). Although there was no significant difference in failure rates among patients infected with different STs, ST2/ST5 strains were significantly more likely to cause relapsing infections (85.7%, P = 0.02). Conclusion WGS could offer a prognostic tool in the management of S. epidermidis bacteremia. ST2 and ST5 strains may help predict a complicated bacteremia course which would warrant appropriate antimicrobial therapy. Disclosures T. L. Holland, Basilea: Consultant, Consulting fee. Motif Bio: Consultant and Scientific Advisor, Consulting fee. Theravance: Consultant, Speaker honorarium. Genentech: Consultant, Consulting fee. V. G. Fowler Jr., Debiopharm: Consultant, Consulting fee. Durata: Consultant, Consulting fee. Merck: Consultant and Scientific Advisor, Consulting fee. Cerexa/Actavis/Allergan: Grant Investigator, Grant recipient. Pfizer: Consultant and Grant Investigator, Consulting fee and Grant recipient. Advanced Liquid Logics: Grant Investigator, Grant recipient. NIH: Grant Investigator, Grant recipient. MedImmune: Consultant and Grant Investigator, Consulting fee and Grant recipient. Basilea: Consultant and Grant Investigator, Consulting fee and Grant recipient. Karius: Grant Investigator, Grant recipient. Contrafect: Consultant and Grant Investigator, Consulting fee and Grant recipient. Regeneron: Grant Investigator, Grant recipient. Genentech: Consultant and Grant Investigator, Consulting fee and Grant recipient. Affinergy: Consultant and Grant Investigator, Consulting fee and Grant recipient. Locus: Grant Investigator, Grant recipient. Medical Surface, Inc.: Grant Investigator, Grant recipient. Theravance: Consultant, Consulting fee and Speaker honorarium. Green Cross: Consultant, Speaker honorarium. Grifols: Consultant, Consulting fee. xBiotech: Consultant, Consulting fee. Achaogen: Consultant, Consulting fee. Medicines Co: Consultant, Consulting fee. Novartis: Consultant, Consulting fee. Novadigm: Consultant, Consulting fee. Bayer: Consultant, Consulting fee. Cubist: Consultant, Consulting fee. Debiopharm: Consultant, Consulting fee. Durata: Consultant, Consulting fee. I. Raad, The University of Texas MD Anderson Cancer Center: Shareholder, Licensing agreement or royalty. The Unversity of Texas MD Anderson Cancer Center: Shareholder, Dr. Raad is a co-inventor of the Nitroglycerin-Citrate-Ethanol catheter lock solution technology which is owned by the University of Texas MD Anderson Cancer Center (UTMDACC) and has been licensed to Novel Anti-Infective Technologies LLC, in which UTMDACC and Licensing agreement or royalty.

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Henderson, Heather, Eric Cober, Sandra S. Richter, Robert Salata, Robert Kalayjian, Richard Watkins, Yohei Doi i in. "1180. Addition of Chronic Kidney Disease Status to Pitt Bacteremia Score Improves Prediction of Mortality in Patients With Carbapenem-Resistant Enterobacteriaceae Infections". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S356—S357. http://dx.doi.org/10.1093/ofid/ofy210.1013.

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Abstract Background Carbapenem-resistant Enterobacteriaceae (CRE) infections are associated with high mortality. The Pitt Bacteremia Score (PBS) was developed and validated to predict mortality in bloodstream infections (BSI). The first goal of this analysis is to evaluate whether PBS also predicts mortality in non-BSI infections. Second, we determine whether adding chronic kidney disease (CKD) as a parameter to PBS improves prediction of mortality. Methods The Consortium on resistance against carbapenems in Klebsiella and other Enterobacteriaceae (CRACKLE-1) is a prospective multicenter consortium of hospitals. Each patient with CRE infection was included once at the time of the last positive culture episode. Infections were distinguished from colonization using established definitions. Relative risk regression was used to evaluate the association of PBS ≥4 and CKD with 14-day all-cause hospital mortality. Results From December 2011 to June 2016, 364 unique patients were included with the following infections: bloodstream (34%), respiratory (20%), urinary (30%), and wound (16%). Median PBS was 3 (IQR: 2–4); 45% of patients had PBS ≥4. CKD was present in 31% of patients with PBS ≥4 and 20% of patients with PBS <4. All-cause mortality within 14 days of the last positive culture episode was 20%. In multivariable analysis, PBS ≥4 was strongly associated with mortality in patients with bacteremia (PBS ≥4 adjusted RR = 6.1, 95% CI 2.5–14.6, CKD aRR = 1.5, 95% CI 0.9–2.3) and in patients with other infections (PBS ≥4 aRR = 14.0, 95% CI 4.3–44.6, CKD aRR = 1.6, 95% CI 1.0–2.7). Adding CKD as a parameter to the PBS improved mortality prediction, specifically in patients with PBS ≥4 (figure). Conclusion As expected, PBS ≥4 was predictive of the 14-day risk of hospital mortality in this cohort of CRE bacteremic patients. In patients with other CRE infections, PBS ≥4 was also predictive of mortality. In this cohort, adding CKD to the PBS improved prediction of mortality patients with PBS ≥4. Disclosures S. S. Richter, bioMerieux: Grant Investigator, Research grant. BD Diagnostics: Grant Investigator, Research grant. Roche: Grant Investigator, Research grant. Hologic: Grant Investigator, Research grant. Diasorin: Grant Investigator, Research grant. Accelerate: Grant Investigator, Research grant. Biofire: Grant Investigator, Research grant. V. G. Fowler Jr., Merck: Consultant and Scientific Advisor, Consulting fee. Cerexa/Actavis/Allergan: Grant Investigator, Grant recipient. Pfizer: Consultant and Grant Investigator, Consulting fee and Grant recipient. Advanced Liquid Logics: Grant Investigator, Grant recipient. NIH: Grant Investigator, Grant recipient. MedImmune: Consultant and Grant Investigator, Consulting fee and Grant recipient. Basilea: Consultant and Grant Investigator, Consulting fee and Grant recipient. Karius: Grant Investigator, Grant recipient. Contrafect: Consultant and Grant Investigator, Consulting fee and Grant recipient. Regeneron: Grant Investigator, Grant recipient. Genentech: Consultant and Grant Investigator, Consulting fee and Grant recipient. Affinergy: Consultant and Grant Investigator, Consulting fee and Grant recipient. Locus: Grant Investigator, Grant recipient. Medical Surface, Inc.: Grant Investigator, Grant recipient. Theravance: Consultant, Consulting fee and Speaker honorarium. Green Cross: Consultant, Speaker honorarium. Grifols: Consultant, Consulting fee. xBiotech: Consultant, Consulting fee. Achaogen: Consultant, Consulting fee. Medicines Co: Consultant, Consulting fee. Novartis: Consultant, Consulting fee. Novadigm: Consultant, Consulting fee. Bayer: Consultant, Consulting fee. Cubist: Consultant, Consulting fee. Debiopharm: Consultant, Consulting fee. Durata: Consultant, Consulting fee. D. Van Duin, Shionogi: Scientific Advisor, Consulting fee. achaogen: Scientific Advisor, Consulting fee. Allergan: Scientific Advisor, Consulting fee. Astellas: Scientific Advisor, Consulting fee. Neumedicine: Consultant, Consulting fee. T2 Biosystems: Scientific Advisor, Consulting fee. Roche: Scientific Advisor, Consulting fee.

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Kociolek, Larry, Ciaran P. Kelly, Robyn Espinosa, Maria Budz, Aakash Balaji, Egon Ozer, Robert Tanz, Xinhua Chen i Dale N. Gerding. "976. Clostridium difficile Colonization Molecular Epidemiology and Anti-toxin Serological Responses in Healthy Infants: A Prospective Cohort Study". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S39—S40. http://dx.doi.org/10.1093/ofid/ofy209.092.

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Abstract Background Infant C. difficile colonization is common, but the molecular epidemiology and immunologic consequences of colonization are poorly understood. Methods In this prospective cohort study of healthy infants, serial stools collected between 1–2 and 9–12 month olds were tested for glutamate dehydrogenase (detects nontoxigenic or toxigenic C. difficile [TCD]), tcdB PCR (detects TCD), and cultured for C. difficile. Isolates underwent whole genome sequencing and multilocus sequence typing (MLST). Clonal strains were identified by single nucleotide variant (SNV) analysis. TCD was confirmed by BLAST identification of tcdA/tcdB. Serum collected at 9–12 month olds underwent ELISA for measurement of IgA, IgG, and IgM against TCD toxins A and B. For comparison, anti-toxin IgG was measured in cord blood of 50 consecutive full-term deliveries (unrelated to study infants). Arbitrary ELISA units were compared by Wilcoxon rank-sum test. Results Among 32 infants, 16 (50%) had at least one TCD+ stool, 12 of whom were colonized at least 1 m prior to serology measurements (Figures 1 and 2). A variety of STs were identified, and evidence of putative in-home (enrolled siblings) and outpatient clinic transmission was identified (Figure 3). Infants with TCD colonization had significantly greater levels of anti-toxin IgA and IgG compared with non-colonized infants and IgG compared with unrelated cord blood (Table 1). Conclusion Infant C. difficile colonization is a dynamic process with variable strain types and duration. Outpatient clinics may be a C. difficile reservoir for some patients. TCD colonization is associated with a humoral immune response against toxins A and B, but whether natural TCD immunization protects against CDI later in life requires further investigation. Disclosures L. Kociolek, Alere/Techlab: Investigator, Research support. C. P. Kelly, Actelion: Consultant, Consulting fee. Artugen: Consultant, Consulting fee. Facile: Consultant, Consulting fee. GSK: Consultant, Consulting fee. MSD: Consultant, Consulting fee. Seres: Consultant, Consulting fee. Summit: Consultant, Consulting fee. Vedanta: Consultant, Consulting fee. D. N. Gerding, Merck: Scientific Advisor, Consulting fee. Actelion: Scientific Advisor, Consulting fee. DaVolterra: Scientific Advisor, Consulting fee. Summit: Scientific Advisor, Consulting fee. Rebiotix: Medical Officer and Scientific Advisor, Consulting fee. Pfizer: Consultant, Consulting fee. MGB Pharma: Consultant, Consulting fee. sanofi pasteur: Consultant, Consulting fee. Seres: Investigator, Research grant. CDC: Investigator, Research grant. US Dept VA: Investigator, Research grant. Treatment/Prevention of C. difficile: Patent Holder, no license or royalties.

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Bergin, Stephen P., Adrian Coles, Sara B. Calvert, John Farley, Jonas Santiago, Marcus J. Zervos, Ana Cecilia Bardossy i in. "872. PROPHETIC: Predicting Pneumonia in Hospitalized Patients in the ICU—A Model and Scoring System". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S25. http://dx.doi.org/10.1093/ofid/ofy209.056.

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Abstract Background Prospectively identifying patients at highest risk for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) by implementing a risk assessment scoring tool may help focus prevention efforts, optimize the screening process to improve clinical trial feasibility, and enhance development of new antibacterial agents. Methods Within the intensive care units (ICU) of 28 US hospitals, between February 6, 2016 and October 7, 2016, patients hospitalized >48 hours and receiving high levels of respiratory support were prospectively followed for meeting the definition of HABP/VABP recommended in US FDA draft guidance. Patient demographics, medical comorbidities, and treatment exposures were recorded. The association between candidate risk factors and odds of developing HABP/VABP was evaluated with a multivariable logistic regression model. Risk factors were selected using backward selection with α = 0.1 for model inclusion. A web-based scoring system was developed to estimate the risk of HABP/VABP from the risk factors identified. Results A total of 5,101 patients were enrolled, of whom 1,005 (20%) developed HABP/VABp. 4,613 patients were included in the model, excluding 488 (10%) with HABP/VABP at or before enrollment. There are 15 variables included in the model. APACHE II admission score >20 (P < 0.001, OR 2.14, 95% CI 2.00–2.29), admission diagnosis of trauma (P < 0.001, OR 3.31, 95% CI 1.90–5.74), frequent oral or lower respiratory tract suctioning (P < 0.001, OR 2.33, 95% CI 1.81–2.99), and receipt of enteral nutrition (P < 0.001, OR 2.31, 95% CI 1.69–3.16) were the key drivers of increased pneumonia risk. The model demonstrated excellent discrimination (bias-corrected C-statistic 0.861, 95% CI 0.843–0.880). The web-based scoring system can be accessed via this link: https://ctti-habpvabp.shinyapps.io/web_based_tool/. Conclusion Using a web-based scoring system, ICU patients at highest risk for developing HABP/VABP can be accurately identified. Prospective implementation of this tool may assist in focusing additional prevention efforts on the highest risk patients and enhance new drug development for HABP/VABP. Disclosures S. P. Bergin, CTTI: Investigator and Scientific Advisor, Research support and Travel to study related meetings. A. Coles, CTTI: Investigator and Scientific Advisor, Salary. S. B. Calvert, CTTI: Employee, Salary. M. J. Zervos, CTTI: Investigator, Research support. A. C. Bardossy, CTTI: Investigator, Research support. M. Kollef, CTTI: Investigator, Research support. M. J. Durkin, CTTI: Investigator, Research support. M. Sims, CTTI: Investigator, Research support. C. Greenshields, CTTI: Investigator, Research support. B. A. Kabchi, CTTI: Investigator, Research support. H. K. Donnelly, CTTI: Collaborator and Scientific Advisor, Research support and Salary. P. Tenaerts, CTTI: Employee, Salary. P. Gu, CTTI: Collaborator, Research support and Salary. V. G. Fowler Jr., CTTI: Investigator and Scientific Advisor, Research support and Salary. Merck: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Grant recipient and Research support. Cerexa/Actavis/Allegan: Grant Investigator, Grant recipient. Pfizer: Consultant and Grant Investigator, Consulting fee and Grant recipient. Advanced Liquid Logics: Grant Investigator, Grant recipient. NIH: Investigator, Grant recipient, Research support and Salary. MedImmune: Consultant and Grant Investigator, Consulting fee and Grant recipient. Basilea: Consultant and Grant Investigator, Consulting fee and Grant recipient. Karius: Grant Investigator, Grant recipient. Contrafect: Consultant and Grant Investigator, Consulting fee and Grant recipient. Regeneron: Grant Investigator, Grant recipient. Genentech: Consultant and Grant Investigator, Consulting fee and Grant recipient. Achaogen: Consultant, Consulting fee. Astellas: Consultant, Consulting fee. Arsanis: Consultant, Consulting fee. Affinergy: Consultant, Consulting fee. Bayer: Consultant, Consulting fee. Cerexa: Consultant, Consulting fee. Cubist: Consultant, Consulting fee. Debiopharm: Consultant, Consulting fee. Durata: Consultant, Consulting fee. Grifols: Consultant, Consulting fee. Medicines Co.: Consultant, Consulting fee. Novartis: Consultant, Consulting fee. Novadigm: Consultant, Consulting fee. Theravance: Consultant, Consulting fee and Speaker honorarium. xBiotech: Consultant, Consulting fee. Green Cross: Consultant, Speaker honorarium. T. L. Holland, CTTI: Investigator and Scientific Advisor, Research support and Salary.

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Bronnenmayer, Matias, Bernd W. Wirtz i Vincent Göttel. "Determinants of perceived success in management consulting". Management Research Review 39, nr 6 (20.06.2016): 706–38. http://dx.doi.org/10.1108/mrr-06-2014-0145.

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Purpose This paper aims to conceptualize perceived management consulting success, derive relevant success factors based on principal-agent theory and the resource-based view as well as investigate the particular factors’ influence. Management consulting has become important for improving the competitiveness of a variety of firms. Surprisingly, there is little empirical evidence clarifying what constitutes a successful management consulting project. Design/methodology/approach The authors conduct a survey to empirically investigate the hypotheses. They develop the survey instrument through a literature review, expert interviews, a pre-test and an item-sorting test. To analyze the data from 348 management consultants, the authors apply structural equation modeling. Additionally, they choose a triangulation approach by asking secondary informants about the originally surveyed consultants’ responses. Findings Initially, the authors develop the second-order construct perceived management consulting success, consisting of the factors compliance with budget and schedule, degree of target achievement, profitability as well as expansion and extension. Additionally, they develop an understanding of management consulting’s success factors. In this regard, five of six factors show a significant impact on perceived management consulting success. Originality/value According to the results, the factor intensity of collaboration is of highest importance for perceived management consulting success. Further, the factors common vision, consultant expertise and top management support show comparably strong significant influences. Yet, the authors have to reject the hypothesis about trust. This result conveys the complicacy of the consultant–client relationship and shows that building a trustful relationship between both parties is hard to accomplish.

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Farrands, Rob. "Sustaining Dynamic Tension When Consulting To Complex Systems". British Gestalt Journal 10, nr 1 (1.07.2001): 4–12. http://dx.doi.org/10.53667/krwu6742.

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"Abstract: The purpose of this article is to provide an account of the work of an organisation consultant hm a Gestalt perspective. The first describes a particular assignment with a strategy team working on behalf of a multinational oil company in an intense examination of technical and strategic scenarios for the first half of this century. This includes an account of how the consultant struggled to make use of his own bewilderment, and sought to sustain 'stmnger-n~s' in his relationship with the client system. The second part is a more theoretical reflection upon the dialectical forces at play as the consultant creates a consulting approach that seeks to integrate the team around a common story, while also numrhg their connection to the complex world of the larger system. The paper also explores the way in which working with different levels of system requires that mutually exclusive goals have to be held in a dynamic tension. In a final part the consultant considers his Gestalt heritage and how this has influenced the choices he has made on this assignment. Key words: organisation consulting, strategy development, levels of system, system boundaries, presenceI pmms consultin& energy, contact, Gestalt."

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Choo, Yang-Hyun, Soon-Jin Choo i Seung-Hee Lee. "A Study on Consultant’s Social Value, Learning, Leadership Type Influence on Consulting Flow and Performance". Asian Social Science 14, nr 8 (27.07.2018): 27. http://dx.doi.org/10.5539/ass.v14n8p27.

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The purpose of this study is to investigate consultants in ongoing consulting projects for smaller enterprises to implement an empirical study on the degree of influence of consultant value, consultant learning and consultant leadership type on consulting performance, which have not been mentioned in preceding study. The surveyed were consultants who had provided consulting service to smaller enterprises. For the study, a total of 223 sets of questionnaires were collected but 18 poorly-answered sets were excluded to utilize 205 sets for the study research. As a summary of the results, the social responsibility had a significant effect on consulting Flow whereas social support did not. learning motivation, learning intention and transformational/transactional/servant leadership on consulting Flow found that all of the variables had a significant effect on consulting Flow. In addition to that, social responsibility, support and learning motivation, learning intention and transformational/transactional/servant leadership on consulting satisfaction found that all of the variables significantly affected consulting satisfaction.

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Wohl, David A., Yazdan Yazdanpanah, Axel Baumgarten, Amanda Clarke, Melanie Thompson, Cynthia Brinson, Debbie Hagins i in. "LB4. A Phase 3, Randomized, Controlled Clinical Trial of Bictegravir in a Fixed-Dose Combination, B/F/TAF, vs. ABC/DTG/3TC in Treatment-Naïve Adults at Week 96". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S760—S761. http://dx.doi.org/10.1093/ofid/ofy229.2178.

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Abstract Background Bictegravir (B), a potent INSTI with a high barrier to resistance, is coformulated with emtricitabine (F) and tenofovir alafenamide (TAF) as the FDA-approved single-tablet regimen B/F/TAF. We report Week 96 results from an ongoing phase 3 study comparing B/F/TAF to coformulated dolutegravir, abacavir, and lamivudine (DTG/ABC/3TC) in treatment-naïve adults living with HIV-1. Primary outcome at W48 demonstrated noninferior virologic responses, similar bone and renal profiles, and no viral resistance. Methods We randomized 1:1 HLA-B*5701-negative adults, without HBV and with estimated glomerular filtration rate (eGFR) ≥50 mL/minute to receive blinded B/F/TAF (50/200/25 mg) or DTG/ABC/3TC (50/600/300 mg) with matching placebos QD. Primary endpoint was proportion with HIV-1 RNA <50 copies/mL at W48 (FDA snapshot), with secondary analyses at W96. Noninferiority was assessed with 95% confidence intervals (CI) (12% margin). Other secondary endpoints were safety (adverse events [AEs], laboratory abnormalities) and predefined analyses of bone mineral density (BMD) and measures of renal function (eGFR, proteinuria). Results A total of 629 adults were randomized/treated (314 B/F/TAF, 315 DTG/ABC/3TC). At W96, B/F/TAF was noninferior to DTG/ABC/3TC: 87.9% vs. 89.8%, respectively, achieved HIV-1 RNA <50 copies/mL (difference −1.9%; 95%CI −6.9% to 3.1%, P = 0.45). In per-protocol analysis, 99.6% on B/F/TAF vs. 98.9% on DTG/ABC/3TC achieved HIV-1 RNA <50 copies/mL (P = 0.33). Most common AEs overall were nausea (11% B/F/TAF, 24% DTG/ABC/3TC, P < 0.001), diarrhea (15%, 16%), and headache (13%, 16%). Through W96, no participant had emergent resistance to study drugs. No participant discontinued B/F/TAF due to AEs; five (2%) discontinued DTG/ABC/3TC due to AEs (one after W48). Treatment-related AEs occurred in 28% B/F/TAF vs. 40% DTG/ABC/3TC (P = 0.002); most common was nausea (6%, 17%. P < 0.001). At W96, mean percentage changes in spine and hip BMD were small and similar between groups (table); median change in eGFR was significantly less with B/F/TAF, while median % changes in proteinuria were similar. Conclusion At W96, B/F/TAF was virologically noninferior to DTG/ABC/3TC, with no viral resistance or safety-related discontinuations. B/F/TAF was well tolerated with less nausea than DTG/ABC/3TC and similar bone and renal safety. Disclosures D. A. Wohl, Gilead: Grant Investigator and Scientific Advisor, Consulting fee and Research grant. Y. Yazdanpanah, AbbVie: Consultant, Consulting fee. Bristol-Myers Squibb: Consultant, Consulting fee. Gilead: Consultant, Consulting fee. MSD: Consultant, Consulting fee. Pfizer: Consultant, Consulting fee. Johnson & Johnson: Consultant, Consulting fee. ViiV Healthcare: Consultant, Consulting fee. A. Baumgarten, AbbVie: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. BMS: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. Gilead: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. Janssen-Cilag: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. MSD: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. ViiV: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. A. Clarke, GSK: Scientific Advisor, Consulting fee. Gilead: Conference attendence, Scientific Advisor and Speaker’s Bureau, Conference attendance support, Consulting fee and Speaker honorarium. BMS: Conference attendence, Conference attendance support. Janssen: Conference attendence, Conference attendance support. M. Thompson, Bristol Myers Squibb: Research Contractor, Research support. ViiV Healthcare: Research Contractor, Research support. C. Brinson, Gilead: Investigator, Scientific Advisor and Speaker’s Bureau, Research support and Speaker honorarium. Theratech: Investigator, Research support. BMS: Investigator, Research support. SlieaGen: Investigator, Research support. GSK ViiV: Consultant, Investigator and Scientific Advisor, Consulting fee, Research support and Speaker honorarium. Daiichi Sankyo: Sub Investigator, Research support. Novo Nordisk: Investigator, Research support. Sanofi: Investigator, Research support. Watson: Investigator, Research support. Salix: Investigator, Research support. Janssen: Investigator, Research support. Roche: Investigator, Research support. Colucid: Investigator, Research support. Eisai: Investigator, Research support. Shionogi: Investigator, Research support. Elcelyx: Investigator, Research support. Sangamo: Sub Investigator, Research support. D. Hagins, GlaxoSmithKline: Scientific Advisor and Speaker’s Bureau, Honoraria and Speaker honorarium. ViiV Healthcare: Scientific Advisor and Speaker’s Bureau, Honoraria and Speaker honorarium. Gilead: Scientific Advisor, Honoraria and Speaker honorarium. Bristol-Myers Squibb: Scientific Advisor and Speaker’s Bureau, Honoraria and Speaker honorarium. M. Ramgopal, Gilead: Grant Investigator, Research grant. A. Antinori, AbbVie: Consultant, Consulting fee. BMS: Consultant and Grant Investigator, Consulting fee and Research grant. Gilead: Consultant and Grant Investigator, Consulting fee and Research grant. Janssen-Cilag: Consultant and Grant Investigator, Consulting fee and Research grant. Merck: Consultant, Consulting fee. ViiV Healthcare: Consultant and Grant Investigator, Consulting fee and Research grant. X. Wei, Gilead: Shareholder, Salary and Stock. K. White, Gilead: Employee and Shareholder, Salary and Stock. S. Collins, Gilead: Employee and Shareholder, Salary and Stock. A. Cheng, Gilead: Employee and Shareholder, Salary and Stock. E. Quirk, Gilead: Employee and Shareholder, Salary and Stock. H. Martin, Gilead: Employee and Shareholder, Salary and Stock.

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Abrahamian, Fredrick M., George Sakoulas, Evan Tzanis, Amy Manley, Judith N. Steenbergen, Anita Das, Paul Eckburg i Paul McGovern. "1347. Omadacycline for Acute Bacterial Skin and Skin Structure Infections: Integrated Analysis of Randomized Clinical Trials". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S412. http://dx.doi.org/10.1093/ofid/ofy210.1178.

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Abstract Background Skin infections are a significant medical burden for affected individuals and the healthcare system. The purpose of this investigation was to integrate the findings of two randomized studies of omadacycline (OMC) in ABSSSI. Methods OMC in Acute Skin and Skin Structure Infections Study (OASIS)-1 initiated patients on intravenous (IV) OMC or linezolid (LZD) with a possible transition to oral formulation after at least 3 days of IV therapy. OASIS-2 investigated oral-only OMC. Treatment duration in both studies was 7–14 days. Early clinical response (ECR) in the mITT population, the primary endpoint in both studies, was defined as a ≥20% reduction in lesion size at 48–72 hours after treatment initiation. The secondary endpoint was investigator assessment of clinical response (IACR) at post-therapy evaluation (PTE) in the mITT and CE populations, 7–14 days after treatment initiation. Results A total of 691 patients receiving OMC and 689 patients receiving LZD were included. The mean age of patients was 45 years, 64% were male, and 83% enrolled at US sites. Infection types: wound infections (46.8%), cellulitis/erysipelas (30.5%), major abscess (22.7%). Median lesion size was 316 cm2 and 304 cm2 in OMC and LZD patients, respectively. S. aureus was detected in 74.6% of patients, of which 43.4% had MRSA. 71% were mono-microbial Gram-positive infections, 15% were poly-microbial Gram-positive infections. OMC showed similar efficacy to LZD for the primary and secondary endpoints, as well as for mono-microbial and poly-microbial infections (figure). Clinical responses were similar across different infection types, lesion sizes, and baseline pathogens. Treatment-emergent adverse events (TEAEs), most mild or moderate, were reported by 51% and 41% of patients receiving OMC or LZD, respectively. Nausea and vomiting were more frequent for OMC patients in the OASIS-2 oral-only study while receiving the loading dose on Day 1 and 2. Serious AEs were reported by 2.3% and 1.9%, respectively. TEAEs leading to study drug discontinuation were reported by 1.7% and 1.5%, respectively. Conclusion The integrated analysis of OASIS trials showed that oral and IV omadacycline was effective in the treatment of ABSSSI and was safe and generally well-tolerated by patients. Disclosures F. M. Abrahamian, Allergan: Speaker’s Bureau, Speaker honorarium. Melinta: Speaker’s Bureau, Speaker honorarium. Merck: Speaker’s Bureau, Speaker honorarium. Nabriva: Scientific Advisor, Consulting fee. Paratek: Scientific Advisor, Consulting fee. G. Sakoulas, Allergan: Consultant and Speaker, Consulting fee and Speaker honorarium. Sunovion Pharmaceuticals: Speaker, Speaker honorarium. The Medicines Company: Speaker, Speaker honorarium. Paratek Pharmaceuticals: Consultant, Consulting fee. Cidara Therapeutics: Scientific Advisor, Consulting fee. Arsanis Pharmaceuticals: Scientific Advisor, Consulting fee. E. Tzanis, Paratek Pharmaceuticals: Employee, Salary. A. Manley, Paratek Pharmaceuticals: Employee and Shareholder, Salary. J. N. Steenbergen, Paratek Pharmaceuticals: Employee and Shareholder, Salary. A. Das, Achaogen: Consultant, Consulting fee. Cempra: Consultant, Consulting fee. Contrafect: Consultant, Consulting fee. Nabriva: Consultant, Consulting fee. Paratek: Consultant, Consulting fee. Tetraphase: Consultant, Consulting fee. Theravance: Consultant, Consulting fee. Wockhardt: Consultant, Consulting fee. P. Eckburg, Paratek: Consultant, Consulting fee. P. McGovern, Paratek Pharmaceuticals: Employee, Salary.

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Marty, Francisco M., Per Ljungman, Roy F. Chemaly, Hong Wan, Valerie L. Teal, Joan Butterton, Wendy W. Yeh, Randi Y. Leavitt i Cyrus Badshah. "1730. Outcomes of Patients With Detectable Cytomegalovirus (CMV) DNA at Randomization in the Double-blind, Placebo-Controlled Phase 3 Trial of Letermovir (LET) Prophylaxis for CMV-Seropositive Allogeneic Hematopoietic-Cell Transplantation (HCT) Recipients". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S56—S57. http://dx.doi.org/10.1093/ofid/ofy209.136.

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Abstract Background LET prophylaxis through HCT Week 14 was highly effective in preventing clinically significant CMV infection (CS-CMVi), had a good safety profile, and was associated with lower all-cause mortality by HCT Week 24 compared with placebo (PBO). Patients with detectable CMV DNA at randomization were excluded from the trial’s efficacy analyses (NCT02137772). Here we report the outcomes of these patients. Methods We compared patients randomized 2:1 and treated with LET or PBO who had detectable CMV DNA at randomization (n = 70) to those with undetectable CMV DNA (n = 495; primary efficacy population, PEP). CS-CMVi was defined as CMV viremia requiring antiviral preemptive therapy (PET) or CMV disease; patients with missing data were imputed as events. PET was prescribed blinded to study drug. We analyzed CS-CMVi incidence, CMV viral load (VL) kinetics, and mortality using post study vital status. Detectable, nonquantifiable CMV VL (<151 c/mL) was imputed as 150 c/mL. Results Of 70 patients with detectable CMV DNA at randomization (48 LET, 22 PBO), CMV VL was 150 c/mL in 63 patients (range, 150–716). All patients had undetectable CMV VL ≤5 days before randomization. Baseline characteristics were similar to the PEP, except for more patients with myeloablative conditioning (62.9% vs. 48.3%) and longer median days post-HCT to start of study drug (15 days vs. 8 days). Median study drug exposure was 70 days (range, 1–113) in LET group and 14 days (range, 7–99) in PBO group. By HCT Week 14, CS-CMVi occurred in 15 (31.3%) LET-treated patients and 17 (77.3%) PBO patients; CS-CMVi with imputed events were 22 (45.8%) in LET group and 20 (90.9%) in PBO group (difference –44.8%; 95% CI, –64.7% to –24.8%; P < 0.0001). Median CMV VL at time of PET was 413 c/mL (range, 150–31,847) and was similar between groups. Eight patients had quantifiable CMV VL (range, 171–1,728 c/mL) 1 week after starting study drug: 6 did not receive PET (5 LET [10.4%], 1 PBO [4.5%]). CMV VL was undetectable subsequently; other 2 withdrew from study. One (2.1%) LET-treated patient developed breakthrough CMV viremia with a UL56 C325W mutation. HCT Week 48 all-cause mortality was 26.5% in LET and 40.9% in PBO (figure). Conclusion LET prevented CS-CMVi compared with PBO among patients with detectable CMV DNA at randomization. Disclosures F. M. Marty, Merck: Consultant and Investigator, Consulting fee, Research support and Speaker honorarium. Astellas: Consultant and Investigator, Consulting fee and Research support. Chimerix: Consultant and Investigator, Consulting fee and Research support. Fate Therapeutics: Consultant, Consulting fee. GlaxoSmithKline: Consultant, Consulting fee. LFB: Consultant, Consulting fee. Roche Molecular Diagnostics: Consultant, Consulting fee. Shire: Consultant and Investigator, Consulting fee and Research support. Cidara: Investigator, Research support. Ansun: Investigator, Research support. Gilead: Investigator, Research support. WHISCON: Investigator, Research support. P. Ljungman, Merck: Investigator, Research support. AiCuris: Consultant, Consulting fee. Astellas: Investigator, Research support. Oxford Immunotec: Consultant and Investigator, Consulting fee and Research support. R. F. Chemaly, Merck: Consultant and Investigator, Consulting fee and Research support. Chimerix: Consultant and Investigator, Consulting fee and Research support. Astellas: Consultant, Consulting fee. Novartis: Investigator, Research support. Oxford Immunotec: Consultant, Consulting fee. H. Wan, Merck: Employee and Shareholder, Salary. V. L. Teal, Merck: Employee and Shareholder, Salary. J. Butterton, Merck: Employee and Shareholder, Salary. W. W. Yeh, Merck: Employee and Shareholder, Salary. R. Y. Leavitt, Merck: Employee and Shareholder, Salary. C. Badshah, Merck: Employee and Shareholder, Salary.

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Mrochkovskiy, N. "Management Consulting In The Digital Economy". Scientific Research and Development. Economics of the Firm 9, nr 2 (25.06.2020): 67–72. http://dx.doi.org/10.12737/2306-627x-2020-67-72.

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The article discusses the transformation of management consulting in the digital economy: the functions of management consulting and the reasons for the impact of consulting on the functioning and development of business entities are determined. The author classified the types of management consulting in the digital economy as a special form of organizations. In particular, the following classification features were identified: regularity, nature of interaction, degree of standardization, nature of integration of a consultant and a recipient of services, method of payment for consultant services, formalization of consulting services. The article also provides an overview of opportunities for intensifying and increasing the level of financial and economic efficiency of consulting services.

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Chinoperekweyi, Justine. "Transformational Consulting: Shifting from Consultant-centered Solutions to Client-centered Solutions". Management Consulting Journal 6, nr 1 (1.01.2023): 15–23. http://dx.doi.org/10.2478/mcj-2023-0003.

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Abstract Consulting has evolved significantly over the years. This is in response to the changing operating environment and the emerging needs of organizations. To enrich client-consultant relationships, this article explores the changing philosophical positions around consulting and some of the applied techniques to make consulting an instrument of help in organizations. To enhance understanding of the varying consulting approaches, the article covers consulting approaches from Sigmund Freud, Karl Marx, Erich Fromm, and Patrick Trottier. The philosophical positions and insights from their work will support the emerging consultant in deepening transformational consulting. Through a review of the literature and reflecting on the author’s consulting practice, the article summarizes approaches to enhance transformational consulting. These approaches advance the humanistic paradigm and as such promotes the co-creation of solutions with the client system. The article positions the Use of Self and Action Research as fundamental to enriching consultants’ productive impact. In addition, the article highlights four strength-based models that enrich the design of client-centered solutions.

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Snydman, David R., Laura A. McDermott, Stephen G. Jenkins, Ellie J. C. Goldstein, Robin Patel, Betty A. Forbes, Stuart Johnson, Dale N. Gerding, Cheleste M. Thorpe i Seth T. Walk. "Epidemiologic Trends in Clostridium difficile Isolate Ribotypes in United States from 2010 to 2014". Open Forum Infectious Diseases 4, suppl_1 (2017): S391. http://dx.doi.org/10.1093/ofid/ofx163.973.

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Abstract Background Trends in the distribution of ribotypes for C. difficile associated diarrheal isolates obtained over time in the United States are lacking. As part of surveillance program for C. difficile susceptibility, we analyzed stool isolates for ribotype distribution from a phase 2 trial of surotomycin (2010–2011) (North America sites) as well as a national surveillance study from 2011–2014. Isolates for the surveillance study were referred from 6 geographically distinct medical centers. Methods C. difficile isolates or C. difficile toxin + stools from patients with C. difficile associated diarrhea (CDAD) were submitted for testing to Tufts Medical Center. Following isolation and confirmation as C. difficile, a random sample of isolates were ribotyped by PCR capillary gel electrophoresis. Results 673 isolates over the 5 years of the analysis have been ribotyped to date. There were 49 unique ribotype designations, and 16 ribotypes had more than 10 isolates. The ribotype distribution by year is shown in the table. Conclusion There has been a change in the frequency of ribotypes over time in the US. Of the most common ribotypes seen, 027 has decreased by over 50% while there has been an increase of 014-020, 002, and 106. 014-020 is now the most common ribotype seen in the US. These data suggest that there is a changing epidemiology of C. difficile in the US and continuous monitoring of the ribotype distributions and clinical implications is warranted. Disclosures D. R. Snydman, Merck: Consultant and Grant Investigator, Consulting fee and Research grant; Shire: Consultant, Consulting fee; Summit PLC: Consultant and Grant Investigator, Consulting fee and Research grant; BioK+: Consultant, Consulting fee; Actelion: Grant Investigator, Research grant; S. G. Jenkins, Cormedix: Consultant, Consulting fee; Bayer: Consultant, Consulting fee; Merck: Grant Investigator and Scientific Advisor, Research grant; E. J. C. Goldstein, Merck: Grant Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee and Grant recipient; Cubist: Grant Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee; Actelion: Grant Investigator, Grant recipient; Summit PLC: Grant Investigator and Scientific Advisor, Grant recipient; R. Patel, Curetis: Consultant, Grant Investigator and Speaker’s Bureau, Consulting fee and Research grant; Pocared: Grant Investigator, Research grant; nanoMR: Grant Investigator, Research grant; BioFire: Grant Investigator, Research grant; Check-Points: Grant Investigator, Research grant; 3M: Grant Investigator, Research grant; Cubist: Grant Investigator, Research grant; Merck: Grant Investigator, Research grant; S. Johnson, Bio-K+: Consultant, Consulting fee; D. N. Gerding, Merck, Shire, Cubist, Rebiotix, sanofi pasteur, Summit, DaVoltera, Actelion: Consultant, Consulting fee; CDC, US Dept of Veterans Affairs Research Service: Grant Investigator, Research grant

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Alexander, Elizabeth, Lisa Goldberg, Anita Das, Gregory J. Moran, Christian Sandrock, Leanne B. Gasink, Patricia Spera i in. "LB6. Oral Lefamulin Is Safe and Effective in the Treatment of Adults With Community-Acquired Bacterial Pneumonia (CABP): Results of Lefamulin Evaluation Against Pneumonia (LEAP 2) Study". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S761. http://dx.doi.org/10.1093/ofid/ofy229.2180.

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Abstract Background Lefamulin, a first in class pleuromutilin, is being developed as an IV and oral formulation for treating CABP. The second of 2 phase 3 Lefamulin Evaluation Against Pneumonia studies, LEAP 2 (NCT02813694; EudraCT 2015-004782-92) evaluating an oral 5-day regimen, is presented here. LEAP 2 complements the positive results from LEAP 1, an IV-to-oral switch study in patients with PORT Risk Class III-V. Methods In this multicenter, randomized, double-blind, double dummy study, patients with CABP were randomized to oral lefamulin 600 mg q12h for 5 days or moxifloxacin 400 mg q24h for 7 days. Adults with PORT Risk Class II–IV were eligible (≥50% were to have PORT Risk Class III or IV). The US FDA primary endpoint was early clinical response (ECR) (96 ± 24 h after first dose) in the intent-to-treat (ITT) population. The EMA coprimary endpoints (FDA secondary endpoints) were investigator assessment of clinical response (IACR) at test of cure (TOC) (5–10 days after last dose) in the modified ITT (mITT) and clinically evaluable (CE) TOC populations. For FDA and EMA endpoints, noninferiority was concluded if the lower limit of the two-sided 95% CI was greater than –10% (Figure 1). Results A total of 738 patients were randomized (n = 370 lefamulin, n = 368 moxifloxacin). Five days of lefamulin was noninferior to 7 days of moxifloxacin for both FDA and EMA primary endpoints (Figure 2). Lefamulin was efficacious regardless of PORT Risk Class (ECR responder rates for PORT II, III, and IV: 91.8% [168/183], 91.0% [132/145], and 85.0% [34/40] for lefamulin; 93.1% [176/189], 90.2% [120/133], and 85.7% [36/42] for moxifloxacin, respectively). Both agents demonstrated similar ECR responder and IACR success rates across baseline CABP pathogens. Rates of serious adverse events (AEs) and AEs leading to discontinuation were low and similar between groups. Most frequently reported AEs were gastrointestinal, the majority of mild severity with few discontinuations. Conclusion Five-day oral lefamulin demonstrated noninferiority for both FDA and EMA efficacy endpoints vs. 7-day oral moxifloxacin. Both agents were safe and generally well tolerated. Lefamulin shows promise as an oral monotherapy with a complete spectrum of antibacterial activity against CABP pathogens. Disclosures E. Alexander, Nabriva: Employee and Shareholder, Salary and Stock Options. L. Goldberg, Nabriva: Employee, Employee Stock Options and Salary. A. Das, Achaogen: Consultant, Consulting fee. Cempra: Consultant, Consulting fee. Contrafect: Consultant, Consulting fee. Paratek: Consultant, Consulting fee. Tetraphase: Consultant, Consulting fee. Wockhardt: Consultant, Consulting fee. Theravance: Consultant, Consulting fee. Zavante: Consultant, Consulting fee. Utility: Consultant, Consulting fee. Former Employee of Nabriva: Employee, Salary. Nabriva: Consultant, Consulting fee. G. J. Moran, Nabriva: Scientific Advisor, Consulting fee. C. Sandrock, Nabriva: Consultant, Consulting fee. L. B. Gasink, Former Employee of Nabriva: Employee, Salary. P. Spera, Nabriva: Employee and Shareholder, Salary. C. Sweeney, Nabriva: Employee, Employee Stock Options and Salary. S. Paukner, Nabriva: Employee and Shareholder, Salary. W. W. Wicha, Nabriva: Employee and Shareholder, Salary. J. Schranz, Nabriva: Employee and Shareholder, Salary.

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Lagnf, Abdalhamid M., Sarah Jorgensen, Evan J. Zasowski, Trang D. Trinh, Sahil Bhatia, Susan L. Davis i Michael J. Rybak. "1073. Predictors of Vancomycin Switch or Escalation in Patients With Methicillin-Resistant Staphylococcus aureus Bloodstream Infection". Open Forum Infectious Diseases 5, suppl_1 (listopad 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 (>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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Huang, David, G. Ralph Corey, Thomas L. Holland, Thomas P. Lodise, William O’Rirodan, Mark Wilcox, Thomas M. File i in. "1338. A Pooled Analysis of Patients With Wound Infections in the Phase 3 REVIVE Trials: Randomized, Double-blind Studies to EValuate the Safety and Efficacy of Iclaprim Vs. Vancomycin for trEatment of Acute Bacterial Skin and Skin Structure Infections". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S409. http://dx.doi.org/10.1093/ofid/ofy210.1170.

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Abstract Background The objective of this evaluation was to provide an analysis of pooled efficacy data from two parallel Phase 3 trials of iclaprim, a diaminopyrimidine dihydrofolate reducatase inhibitor, compared with vancomycin for the treatment of patients with wound infections including surgical site infections (SSI). Methods A pooled analysis of patients with wound infections was conducted from two parallel Phase 3, double-blind, randomized (1:1), active-controlled, multinational, multicenter trials (REVIVE-1 and REVIVE-2), which included a total of 602 patients with wound infections. The data were analyzed separately and then pooled to determine the efficacy of iclaprim 80 mg fixed dose compared with vancomycin 15 mg/kg. Both drugs were administered intravenously every 12 hours for 5 to 14 days according to the investigator assessment of clinical response. The primary endpoint of these studies was to determine whether iclaprim was noninferior (NI; 10% margin) to vancomycin in achieving a ≥20% reduction in lesion size (early clinical response [ECR] at 48 to 72 hours after initiation of the study drug (early time point [ETP]), compared with baseline in the intent-to-treat (ITT) population. Results Iclaprim had similar ECR rates at ETP compared with vancomycin among the subset of patients with wound infections (see table). The median treatment duration for both iclaprim and vancomycin was 7 days (range 5–14 days). Conclusion In this post-hoc analysis of the REVIVE studies, iclaprim achieved NI to vancomycin in both studies, based on ECR at ETP, in the subgroup of patients with wound infections. These results suggest that iclaprim may be a valuable treatment option for patients with wound infections, including SSI, suspected or confirmed to be due to Gram-positive pathogens. Disclosures D. Huang, Motif BioSciences: Employee, Salary. G. R. Corey, Motif BioSciences: Board Member, Consulting fee. T. L. Holland, Basilea: Consultant, Consulting fee. Motif Bio: Consultant and Scientific Advisor, Consulting fee. Theravance: Consultant, Speaker honorarium. Genentech: Consultant, Consulting fee. T. P. Lodise Jr., Motif BioSciences: Board Member, Consulting fee. W. O’Rirodan, Motif BioSciences: Board Member, Consulting fee. M. Wilcox, Motif BioSciences: Board Member, Consulting fee. T. M. File Jr., Motif BioSciences: Board Member, Consulting fee. M. Dryden, Motif BioSciences: Board Member, Consulting fee. B. Balser, Motif BioSciences: Consultant, Consulting fee. E. Desplats, Motif BioSciences: Consultant, Consulting fee.

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Beveridge, Stockton, Bhinnata Piya, Laura Stewart, Mary Louise Lindegren, Tiffanie Markus, William Schaffner i Natasha B. Halasa. "Comparison of Viral Loads in Patients with Co-infections vs. Single-virus Infections". Open Forum Infectious Diseases 4, suppl_1 (2017): S310. http://dx.doi.org/10.1093/ofid/ofx163.723.

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Abstract Background Molecular testing for respiratory viruses in clinical practice is common, often with multiple viruses detected. Viral load has been correlated with illness severity, but correlation of co-detection of viruses and viral load is less clear. We sought to compare cycle threshold (Ct) values, a marker inversely related to viral load, between single vs. co-detection of common respiratory viruses. Methods Children <18 years with respiratory symptoms and/or fever who presented to the ED or were admitted were enrolled. Nasal/throat specimens were obtained and combined. Singleplex qRT-PCR was used to test for 11 respiratory viruses. Clinical and demographic information were collected. Results From 11/15/15-7/15/16, 1255 children were enrolled, with median age of 26.5 months, 53.4% male, 54.3% White, 38.7% Black, 6.4% other, and 23.5% Hispanic. The median days of illness were 3 days. Of the total cohort, 904 (72%) tested positive for at least one viral pathogen. Table 1compares Ct values of single vs. co-detection for each individual virus. Conclusion Single detection with RSV, HRV, AdV, and PIV had lower Ct values, indicating higher viral loads, compared with co-detection with other viruses. Additional research is needed to understand the reason for lower viral loads for co-detection vs. single detection in select respiratory viruses. Disclosures W. Schaffner, Pfizer: Scientific Advisor, Consulting fee. Merck: Scientific Advisor, Consulting fee. Novavax: Consultant, Consulting fee. Dynavax: Consultant, Consulting fee. Sanofi-pasteur: Consultant, Consulting fee. GSK: Consultant, Consulting fee. Seqirus: Consultant, Consulting fee. N. B. Halasa, sanofi pasteur: Research Contractor, Research support. Astra Zeneca: Research Contractor, Grant recipient.

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Opal, Steven, Thomas M. File, Tom Van Der Poll, Paul McGovern, Evan Tzanis i Surya Chitra. "1374. Integrated Safety Summary of Omadacycline: A Novel Aminomethylcycline Antibiotic". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S421. http://dx.doi.org/10.1093/ofid/ofy210.1205.

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Abstract Background Omadacycline (OMC) is a novel aminomethylcycline with activity against Gram-positive, many Gram-negative, anaerobic, and atypical pathogens. It is in clinical development as once-daily oral (PO) and intravenous (IV) monotherapy for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). Cumulative safety results from Phase 3 clinical trials are reported. Methods This pooled safety analysis is based on 2,150 subjects: OASIS-1 (N = 645), OASIS-2 (N = 735) in ABSSSI; OPTIC (N = 770) in CABP. Comparators were linezolid (LZD) 600 mg IV then PO in ABSSSI (n = 689); moxifloxacin (MOX) 400 mg IV then PO in CABP (n = 388). Safety parameters included treatment-emergent adverse events (TEAEs), laboratory evaluations, vital signs, and electrocardiogram (ECG) findings. Results A total of 1,073 subjects received OMC: 705 received OMC IV then PO (ABSSSI, n = 323; CABP, n = 382); 368 received OMC PO only for ABSSSI. Overall, 60.6% were male and 91.6% white; mean age ranges were 44.7–45.1 and 60.9–62.1 years in ABSSSI and CABP studies, respectively. TEAEs were observed in 47.5% (OMC), 41.2% (LZD), and 48.5% (MOX) of subjects, with gastrointestinal events the most common TEAEs. Serious TEAEs were low (3.6% OMC, 1.9% LZD, 6.7% MOX). Nausea (14.9% OMC, 8.7% LZD, 5.4% MOX) and vomiting (8.3% OMC, 3.9% LZD, 1.5% MOX) were the most frequently reported TEAEs. Diarrhea was observed in 2.4% OMC, 2.9% LZD, and 8.0% MOX subjects, with no cases of Clostridium difficile in OMC-treated subjects. Most TEAEs were mild to moderate and did not result in study drug discontinuation (3.1% OMC, 1.5% LZD, 7.0% MOX); 4 OMC, 1 LZD, and 0 MOX subjects discontinued for nausea and vomiting. Frequency of hepatic TEAEs was similar for OMC, LZD, and MOX: 4.3% OMC, 4.1% LZD, and 4.5% MOX subjects had post-baseline ALT >3× upper limit of normal. Vital signs and ECGs had comparable clinically notable values post-baseline in each treatment group. Known tetracycline class adverse events such as fungal infections were similar in all groups. Conclusion Pooled analyses demonstrate a favorable OMC safety profile, consistent with its tetracycline heritage. OMC was generally well tolerated in subjects with ABSSSI and CABP, with infrequent treatment discontinuations. Disclosures T. M. File Jr., BioMerieux: Consultant, Consulting fee; Curetis: Consultant, Consulting fee; Melinta Therapeutics: Consultant, Consulting fee; Merck: Consultant, Consulting fee; Motif Bio: Consultant, Consulting fee; Nabriva Therapeutics: Consultant and Investigator, Consulting fee and Research grant; Paratek Pharmaceuticals: Consultant, Consulting fee; Pfizer: Consultant, Consulting fee. T. Van Der Poll, Paratek Pharmaceuticals: Consultant, Consulting fee. P. McGovern, Paratek Pharmaceuticals: Employee, Salary. E. Tzanis, Paratek Pharmaceuticals: Employee, Salary.

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Daar, Eric, Edwin DeJesus, Peter Ruane, Gordon Crofoot, Godson Oguchi, Catherine Creticos, Jurgen K. Rockstroh i in. "Phase 3 Randomized, Controlled Trial of Switching to Fixed-dose Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Boosted Protease Inhibitor-based Regimens in Virologically Suppressed Adults: Week 48 Results". Open Forum Infectious Diseases 4, suppl_1 (2017): S735. http://dx.doi.org/10.1093/ofid/ofx180.003.

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Abstract Background Boosted protease inhibitor regimens (bPIs) are effective and often used in HIV-infected individuals with difficulties with adherence, but they can have drug–drug interactions and GI adverse effects. Bictegravir (B), a novel, potent integrase strand transfer inhibitor with a high barrier to resistance and low potential for drug–drug interactions, was coformulated with the recommended nucleoside reverse transcriptase inhibitor backbone emtricitabine (FTC)/tenofovir alafenamide (F/TAF) and demonstrated high efficacy and tolerability in randomized studies in treatment-naïve adults. This randomized Phase 3 study assesses efficacy and safety of switching to B/F/TAF from a multi-tablet regimen containing a bPI. Methods HIV-infected adults suppressed on regimens of boosted atazanavir (ATV) or darunavir (DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF) were randomized 1:1 to continue their current bPI regimen or switch to open-label coformulated B/F/TAF (50/200/25 mg) once daily. Primary endpoint was proportion with HIV-1 RNA ≥50 copies/mL (c/mL) at W48 (FDA snapshot). Noninferiority was assessed through 95.002% confidence intervals (CI) using a margin of 4%. Secondary endpoints included proportion with HIV-1 RNA <50 c/mL and safety measures at W48. Results A total of 577 participants were randomized and treated with B/F/TAF (n = 290) or current bPI regimens (n = 287): 17% women, 26% Black, median age 48 years. Most were receiving a bPI with FTC/TDF (85%) at screening. At W48, switching to B/F/TAF was noninferior to continuing bPI with 1.7% in each group having HIV-1 RNA ≥50 c/mL (difference −0.0%; 95.002% CI −2.5% to 2.5%, P = 1.00); the proportion with HIV-1 RNA <50 c/mL was 92.1% in B/F/TAF vs. 88.9% in bPI. No participant on B/F/TAF developed resistance to study drugs. One participant on DRV/ritonavir + ABC/3TC developed a treatment-emergent L74V mutation. Incidence of grade 3 or 4 AEs was similar (B/F/TAF 4%, bPI regimens 6%). No renal discontinuations or tubulopathy cases occurred with B/F/TAF. Conclusion Adults switching to B/F/TAF from a boosted PI maintained high rates of virologic suppression without resistance. B/F/TAF was safe and well tolerated. Disclosures E. Daar, Bristol-Myers Squibb: Consultant, Consulting fee. Gilead Sciences, Inc.: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support. Janssen: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support. Merck: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support. Teva Pharmaceuticals: Consultant and Scientific Advisor, Consulting fee. ViiV: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support. E. DeJesus, Abbott Laboratories; Achillion Pharmaceuticals, Avexa, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Hoffmann LaRoche, Idenix, Janssen, Merck, Pfizer, Sangamo, Taimed, Tobira, and Vertex: Grant Investigator, Research grant. Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, and Vertex: Scientific Advisor, Consulting fee. P. Ruane, Gilead: Investigator, Scientific Advisor and Shareholder, Consulting fee and Research support. Merck: Speaker’s Bureau, Speaker honorarium. Boehringer: Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research support and Speaker honorarium. Janssen: Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research support and Speaker honorarium. Abbott: Investigator, Scientific Advisor and Speaker’s Bureau, Research support and Speaker honorarium. Idenix: Investigator, Research support. ViiV: Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium. BMS: Consultant, Investigator and Speaker’s Bureau, Consulting fee, Research support and Speaker honorarium. G. Crofoot, Gilead: Investigator and Scientific Advisor, Advisory honorarium and Research grant. ViiV: Investigator and Scientific Advisor, Advisory honorarium, Research grant and Research support. C. Creticos, Thera Technologies and ViiV Healthcare: Scientific Advisor, Consulting fee. Gilead sciences, Merck, and ViiV Healthcare: Investigator, Research support. Pfizer: Speaker’s Bureau, Speaker honorarium. J. K. Rockstroh, Abbvie: Consultant and Investigator, Consulting fee and Speaker honorarium. Gilead: Consultant, Investigator and Scientific Advisor, Consulting fee and Speaker honorarium. ViiV: Scientific Advisor, Consulting fee. Janssen: Investigator and Speaker at educational event, Speaker honorarium. J. M. Molina, Gilead, ViiV, Merck, Janssen, BMS and TEVA: Scientific Advisor, Speaker honorarium. Y. P. Liu, Gilead: Employee and Shareholder, Salary and Shareholder. K. Andreatta, Gilead: Employee and Shareholder, Salary and Shareholder. H. Graham, Gilead Sciences: Employee and Shareholder, Salary. A. Cheng, Gilead: Employee and Shareholder, Salary. H. Martin, Gilead Sciences: Employee, Salary. E. Quirk, Gilead: Employee and Shareholder, Salary

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Ivey, Kelsey S., Yuwei Zhu, Natasha B. Halasa, William Schaffner, Angela P. Campbell, Shikha Garg, Jill M. Ferdinands i H. Keipp Talbot. "Estimated Hospitalization Rates for Seasonal Influenza in Adults and Children in Middle Tennessee using a Capture-Recapture Method". Open Forum Infectious Diseases 4, suppl_1 (2017): S316. http://dx.doi.org/10.1093/ofid/ofx163.738.

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Abstract Background Ongoing surveillance of influenza activity is important to monitor variation in disease severity and vaccine effectiveness, but surveillance systems have limitations. The capture-recapture method aims to more comprehensively estimate disease burden by combining data from independent studies. Methods Residents of 8 counties in Middle TN hospitalized with influenza during the 2015-16 influenza A(H1N1pdm09)-predominant season were identified using data from 3 independent CDC-sponsored programs. The Influenza Hospitalization Surveillance Network/Emerging Infections Program (FluSurv-Net/EIP) identifies adult and pediatric cases based on a positive clinician-ordered influenza test. The U.S. Hospitalized Adult Influenza Vaccine Effectiveness Network (HAIVEN) and the New Vaccine Surveillance Network (NVSN) enroll adults (3 hospitals) and children (1 hospital), respectively, with respiratory symptoms with/without fever, and obtain nasal/throat swabs to identify cases of influenza; 2015–2016 was a pilot year for HAIVEN. Using the numbers of matched and unmatched cases detected by two studies, a capture-recapture analysis estimated the total number (N) of influenza-related hospitalizations in the population (Table 1). Due to small sample size, the Chapman equation was used, where N = ((a + b + 1)(a + c + 1)/(a + 1)) – 1. The capture–recapture estimates were adjusted for the hospitals’ market share for acute respiratory illness in middle TN residents (69.2% for children and 23.9% for adults) based on hospital discharge data. Results Capture-recapture analyses based on unadjusted crude data are shown in Figure 1A and 1B. Age-specific rates of hospitalization were then calculated (Figure 1C). Conclusion Using a capture–recapture method, we estimated influenza hospitalization rates of 0.87 (95% CI 0.06–1.68) and 0.80 (95% CI 0.62–0.98) per 1,000 persons among children and adults, respectively. Disclosures N. B. Halasa, sanofi pasteur: Research Contractor, Research support. Astra Zeneca: Research Contractor, Grant recipient. W. Schaffner, Pfizer: Scientific Advisor, Consulting fee. Merck: Scientific Advisor, Consulting fee. Novavax: Consultant, Consulting fee. Dynavax: Consultant, Consulting fee. Sanofi-pasteur: Consultant, Consulting fee. GSK: Consultant, Consulting fee. Seqirus: Consultant, Consulting fee. H. K. Talbot, Gilead: Investigator, Research support. MedImmune: Investigator, Research support. sanofi pasteur: Investigator, Research support. VaxInnate: Scientific Advisor, Consulting fee. Sequirus: Scientific Advisor, Consulting fee.

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Klistorin, Vladimir. "Economic Consulting". Ideas and Ideals 16, nr 1-2 (26.03.2024): 251–66. http://dx.doi.org/10.17212/2075-0862-2024-16.1.2-251-266.

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The article discusses the reasons and motivations behind the demand for consulting services. Particular attention is paid to the motivation of managers of enterprises, organizations and government agencies who resort to the services of external consultants when they have a large number of their own specialists and advisors. On the basis of the analysis of scientiﬁc literature and our own modest experience we draw conclusions that economic consulting is associated with a number of threats and risks both for the consulted organization and for the consultant himself. For enterprises of organizations and state structures the main threat is that, following standard models and schemes, one can miss speciﬁc features of the external environment and internal organization of the object. In addition, recommendations may be implemented incompletely, formally or partially, which may lead to undesirable results. For a consultant, the main threats are conﬂicts of interest and allegations of corruption and insider trading of information. Innovative solutions are the most effective, but at the same time the most risk. Choosing the right consultant and ensuring their competence and independence is a particular challenge. Therefore, the relationship between the consultant and the client is no less important than the tools and technology of his work in the process of making recommendations. Consulting of state structures has a number of peculiarities, the main of which are the hierarchical nature of construction, latent doctrines of departments, motivation of managers and planning horizon of the manager. Economic counseling allows the researcher to get a unique experience that can be used in further work.

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Kobal, Ligia, María Carolina Cebey, Melisa Mandolesi, Juan Fabrizio i Carla David. "MERCADO DE CONSULTORÍA EN ARGENTINA: concepción y desarrollo". Scientia Generalis 4, nr 2 (21.09.2023): 108–27. http://dx.doi.org/10.22289/sg.v4n2a9.

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This research aims to describe the geographical and demographic profile of the consultant in Argentina. This is an exploratory-descriptive study of a quantitative-qualitative nature. At first, the profile of the consultant and the quantitative results are addressed. The qualitative results of the categories 'The start of the consulting market in Argentina' and 'Development of the consulting market' are presented below. In that sense, the study, in addition to covering the gap on the topic, serves as a basis for decision-making and encourages discussions and academic research on the consulting market in Argentina.

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Demissenova, Sh. "ORGANIZATION EXPERIENCE OF SOCIAL AND PEDAGOGICAL CONSULTING AS A TECHNOLOGY FOR FORMING TOLERANCE AND ETHNOCULTURAL COMPETENCE OF PERSONALITY". BULLETIN Series of Pedagogical Sciences 67, nr 3 (30.09.2020): 60–66. http://dx.doi.org/10.51889/2020-3.1728-5496.07.

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The article considers the issues related to the role, features of social and pedagogical consulting in the field of ethnic relations and the requirements for the consultant himself. The history of counseling on the problems of interethnic relations, ethical and emic approaches to counseling are briefly described. The features of the consultation process in consulting on the problems of ethnic relations. The interrelation of positive ethnic identity and tolerance, ethnocultural competence of a person is revealed. The leading role of positive ethnic identity of the client's personality in overcoming ethnic problems has been determined. The role of the consultant is revealed. The requirements for a consultant, for his training and experience are analyzed. The factors that determine the effectiveness of consulting are considered. The actual problems of consulting on the problems of ethnic relations are analyzed. Practical recommendations for consultants based on a theoretical overview, are listed. The experience of social and pedagogical consultations initiated and organized by the Council of Mothers to the Assembly of the People of Kazakhstan Kostanay’s region has been summarized. The most typical requests for consulting are analyzed. The problems and prospects of implementation such a practice are described.

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Arini, I. Gusti Ayu Agustia, i Naniek Noviari. "Faktor-Faktor yang Memengaruhi Pemilihan Karir sebagai Konsultan Pajak". E-Jurnal Akuntansi 31, nr 1 (26.01.2021): 246. http://dx.doi.org/10.24843/eja.2021.v31.i01.p19.

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This study aims to determine whether professional training, professional recognition, work environment, gender roles, and the influence of parents influence career choices as tax consultants. The theory used in this research is Theory of Planned Behavior (TPB). The population in this study were employees of the LMATS Consulting tax consultant and the total sample was 60 employees using the questionnaire method data collection technique with purposive sampling, namely employees of the accounting division or tax division, who have worked at least 1 year with the latest education of D3. Research location at the LMATS Consulting Tax Consultant office. The results of this study indicate that professional training, professional recognition, work environment, gender roles, and the influence of parents have a positive effect on career choices as a tax consultant in the LMATS Consulting tax consultant office. Keywords: Career; Tax Consultant; Employee.

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Kang, Kun-Myong, Yen-Yoo You i Inchae Park. "A Study on the Influence of Consultant Capacity on Consulting Utilization and Social Network: Focused on Moderating Effect of Gender". Research in World Economy 11, nr 2 (23.05.2020): 50. http://dx.doi.org/10.5430/rwe.v11n2p50.

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Background/Objectives: This study will identify social networks and consultant capacity concepts to verify that social networks are important factors and study whether consultant capacity and social networks influence consulting use.Methods/Statistical analysis: The subjects of the study can be companies that have consulted consulting services of SMBs, and the samples were analyzed by conducting a questionnaire survey on more than 240 SMBs that have consulted consulting services in Korea. The survey consisted of 30 questions including 10 demographic items, and Likert 5-point scale was used. In the empirical analysis, descriptive analysis, exploratory factor analysis, confirmatory factor analysis, structural model analysis, and adjustment effect test were analyzed by AMOS 22.0 using SPSS 22.0.Findings: Studies have shown that first, the knowledge of consultants was shown to have a positive effect on the social network. Second, the ability of consultants was found to have a positive effect on social networks. Third, the attitude of consultants was found to have a positive effect on social networks. It is analyzed that the attitude of the consultant is expressed in personal feelings and that a strong network can be formed through a sincere attitude. Fourth, social networks have been found to have a positive effect on consultancy utilization. It means that the utilization of consulting can be improved through the formation of an active social network. Fifth, analyzing the differences in the path between the gender, it was found to be affected by the Moderating effect. In the case of men, consultant knowledge and attitudes have derived positive results in social networks and consulting use. And in the case of women, the ability of consultants became more active in consulting with social networks. Therefore, the difference in the effect between male and female was confirmed statistically.Improvements/Applications: In this study, it was confirmed that there was a difference between men and women when the consultant's ability affected the consulting utilization rate. Therefore, it is necessary to conduct a detailed study of measures to supplement the gender gap in the competence of consultants in SMB consulting.

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Lee, Sojeong, i Young Wook Seo. "An effects of consultant competency and consulting firm environment on the completion of consulting project". Innovation Enterprise Research 7, nr 3 (31.12.2022): 203–21. http://dx.doi.org/10.37297/ier.2022.12.7.3.203.

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Michelsen, B., M. J. Nissen, A. Ciurea, B. Moeller, L. Midtbøll Ørnbjerg, J. Zavada, B. Glintborg i in. "POS0374 HOW WELL DO EULAR/ASAS-EULAR AND NATIONAL TREATMENT RECOMMENDATIONS FOR PSORIATIC ARTHRITIS AND AXIAL SPONDYLOARTHRITIS ALIGN? IS IT TIME FOR AN UPDATE OF NATIONAL TREATMENT RECOMMENDATIONS?" Annals of the Rheumatic Diseases 82, Suppl 1 (30.05.2023): 439.1–440. http://dx.doi.org/10.1136/annrheumdis-2023-eular.285.

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BackgroundNational treatment recommendations are often used to optimize patient care and may differ from international recommendations. Although such potential heterogeneity may affect outcomes, mapping of these differences across European countries was last performed more than a decade ago for axial spondyloarthritis (axSpA) and has never been undertaken in psoriatic arthritis (PsA).[1]ObjectivesTo assess differences and similarities between the EULAR and ASAS-EULAR recommendations for the treatment of patients with PsA and axSpA, respectively, versus national PsA and axSpA treatment recommendations across Europe.MethodsRheumatologists from 15 European countries (Czech Republic, Denmark, Estonia, Finland, Iceland, Italy, Netherlands, Norway, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom) compared the most recent national treatment recommendations for PsA and axSpA with the “EULAR recommendations for the management of PsA with pharmacological therapies: 2019 update”[2]and the “2016 update of the ASAS-EULAR recommendations for axSpA”[3], in an online survey conducted between October 2021 and April 2022. The study was an initiative of the European Spondyloarthritis Research Collaboration Network (EuroSpA RCN).[4]ResultsThree countries (Czech Republic, Netherlands, and Spain) followed all EULAR recommendations for treating patients with PsA and four countries (Czech Republic, Italy, Spain, and Switzerland) all ASAS-EULAR recommendations for axSpA. A total of 4/15 countries had no national treatment recommendations for PsA or axSpA, but had other rules or regulations to follow, for which the comparisons in this study were then performed. The Netherlands had national treatment recommendations for axSpA, but not yet for PsA, for which EULAR recommendations were followed. In six countries, the national treatment recommendations for PsA predated the 2019 EULAR recommendations and in one country the national treatment recommendations for axSpA predated the 2016 ASAS-EULAR recommendations. More differences were seen between the EULAR and the national treatment recommendations for PsA than between the ASAS-EULAR and the national treatment recommendations for axSpA (Figure 1).Discrepancies between international and national treatment recommendations included: Entry criteria for start of a biologic/targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD) varied and were the most stringent in Romania, where DAPSA>28 for PsA and BASDAI>6 and ASDAS≥2.5 for axSpA were required for the start of a bDMARD. Regarding PsA, in two countries (Finland and Switzerland) a conventional synthetic DMARD should be initiated before a b/tsDMARD including in patients with predominantly enthesal or axial disease. In several countries, no preference for IL17 inhibitors was given for PsA patients with significant skin involvement. The positioning of Janus Kinase inhibitors (JAKi) differed across countries, e.g. in Estonia JAKi were indicated after failure of two tumor necrosis factor inhibitors and in Romania JAKi were positioned at the same level as bDMARDs. Phosphodiesterase-4 inhibitors were not in use or not reimbursed in most countries. Analgesics were not specifically mentioned in several of the national treatment recommendations.Figure 1.ConclusionOnly a few European countries incorporated all EULAR and ASAS/EULAR treatment recommendations in their national recommendations. The potential impact of this on access to b/tsDMARD treatments needs to be further explored.References[1]Van den Berg et al. Rheumatology (Oxford) 2011;50:2270-7[2]Gossec L et al. Ann Rheum Dis 2020;79:700-12.[3]van der Heijde D et al. Ann Rheum Dis 2017;76:978-91.[4]eurospa.euAcknowledgementsNovartis Pharma AG for supporting the EuroSpA collaboration.Disclosure of InterestsBrigitte Michelsen Consultant of: Novartis, Grant/research support from: Novartis (paid to employer), Michael J. Nissen Speakers bureau: Consulting and/or speaking fees from AbbVie, Eli Lilly, Janssens, Novartis, Pfizer, Consultant of: Consulting and/or speaking fees from AbbVie, Eli Lilly, Janssens, Novartis, Pfizer, Adrian Ciurea Grant/research support from: Novartis, Burkhard Moeller Speakers bureau: Eli-Lilly, Janssen, Novartis, Pfizer, Grant/research support from: Amgen, Lykke Midtbøll Ørnbjerg Grant/research support from: Novartis, Jakub Zavada Speakers bureau: Abbvie, Eli-Lilly, Sandoz, Novartis, Egis, UCB, Consultant of: Abbvie, Eli-Lilly, Sandoz, Novartis, Egis, UCB, Bente Glintborg Grant/research support from: Pfizer, Abbvie, BMS, Alan MacDonald: None declared, Karin Laas Speakers bureau: Consulting and/or speaking fees from Amgen, Johnson and Johnsen, Novartis, Consultant of: Consulting and/or speaking fees from Amgen, Johnson and Johnsen, Novartis, Dan Nordström Speakers bureau: Consulting and/or speaking fees from Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: Consulting and/or speaking fees from Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Grant/research support from: MSD, Björn Gudbjornsson Speakers bureau: Consulting an/or speaking fees from Novartis and Nordic Pharma, Consultant of: Consulting an/or speaking fees from Novartis and Nordic Pharma, Florenzo Iannone Speakers bureau: Consulting and/or speaking fees from Abbvie, Amgen, AstraZeneca, BMS, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: Consulting and/or speaking fees from Abbvie, Amgen, AstraZeneca, BMS, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Pasoon Hellamand Grant/research support from: Novartis, Tore K. Kvien Speakers bureau: Grünenthal, Sandoz, UCB, Consultant of: AbbVie, Amgen, Celltrion, Gilead, Novartis, Pfizer, Sandoz, UCB, Grant/research support from: AbbVie, Amgen, BMS, Galapagos, Novartis, Pfizer, UCB, Ana Maria Rodrigues Speakers bureau: Consulting and/or speaking fees from Abbvie, Amgen, Consultant of: Consulting and/or speaking fees from Abbvie, Amgen, Grant/research support from: Novartis, Pfizer, Amgen, Catalin Codreanu Speakers bureau: Speaking or consultant fees from AbbVie, Amgen, Boehringer Ingelheim, Ewopharma, Lilly, Novartis, Pfizer, Consultant of: Speaking or consultant fees from AbbVie, Amgen, Boehringer Ingelheim, Ewopharma, Lilly, Novartis, Pfizer, Ziga Rotar Speakers bureau: Abbvie, Novartis, MSD, Medis, Biogen, Eli Lilly, Pfizer, Sanofi, Lek, Janssen, Consultant of: Abbvie, Novartis, MSD, Medis, Biogen, Eli Lilly, Pfizer, Sanofi, Lek, Janssen, Isabel Castrejon Speakers bureau: Speaker and/or consultant fees from BMS, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, MSD, Pfizer. GSK, Consultant of: Speaker and/or consultant fees from BMS, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, MSD, Pfizer. GSK, Johan K Wallman Speakers bureau: Abbvie, Amgen, Consultant of: AbbVie, Amgen, Eli Lilly, Novartis, Pfizer, Jiří Vencovský: None declared, Anne Gitte Loft Speakers bureau: Speaking and/or consultant fees from Abbvie, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: Speaking and/or consultant fees from Abbvie, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: Novartis, Maureen Heddle: None declared, Sigrid Vorobjov: None declared, Anna-Mari Hokkanen Grant/research support from: MSD, Gerdur Gröndal: None declared, Marco Sebastiani Speakers bureau: Speaker and/or consultant fees from Eli Lilly, Janssen, BMS, Pfizer, Galapagos, Boehringer-Ingelheim, Consultant of: Speaker and/or consultant fees from Eli Lilly, Janssen, BMS, Pfizer, Galapagos, Boehringer-Ingelheim, Grant/research support from: BMS, Marleen G.H. van de Sande Speakers bureau: Research grant and/or consulting fees and/or speaker fees from Eli Lilly, Novartis, UCB, Janssen, Abbvie, Consultant of: Research grant and/or consulting fees, and/or speaker fees from Eli Lilly, Novartis, UCB, Janssen, Abbvie, Grant/research support from: Research grant and/or consulting fees, and/or speaker fees from Eli Lilly, Novartis, UCB, Janssen, Abbvie, Eirik kristianslund: None declared, Maria Jose Santos Speakers bureau: Abbvie, Astra Zeneca, Lilly, Novartis, Pfizer, Corina Mogosan: None declared, Matija Tomsic Speakers bureau: Consulting and/or speaking fees from Abbvie, Amgen, Biogen, Eli Lilly, Janssen, Medis, MSD, Novartis, Pfizer, Sanofi, Sandoz, Lek, Consultant of: Consulting and/or speaking fees from Abbvie, Amgen, Biogen, Eli Lilly, Janssen, Medis, MSD, Novartis, Pfizer, Sanofi, Sandoz, Lek, Federico Diaz-Gonzalez: None declared, Daniela Di Giuseppe: None declared, Mikkel Østergaard Speakers bureau: Speaker and/or consulting fees from Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, UCB, Consultant of: Consulting and/or speaking fees from Abbvie, Amgen, Biogen, Eli Lilly, Janssen, Medis, MSD, Novartis, Pfizer, Sanofi, Sandoz, Lek, Merete Lund Hetland Speakers bureau: Pfizer, Medac, Sandoz, Grant/research support from: AbbVie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics B.V, Lundbeck Fonden, MSD, Medac, Pfizer, Roche, Samsung Biopies, Sandoz, Novartis.

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Bae, Hyunju. "The communication competency model development for school consultant: Based on Schein’s Process Consultation perspective". Korea Association for Care Competency Education 8, nr 2 (31.12.2023): 47–77. http://dx.doi.org/10.52616/jccer.2023.8.2.47.

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The competency of school consultants’ is one of the major factors for successful school consulting. Specifically, the communication competency of school consultants is emphasized as a core competency because it is critical for the principle and process of consulting. This study aims to define the competency of school consultants, with a specific focus on elucidating the educational communication competency based on Schein’s Process Consultation perspective. The competency of school consultants can be categorized into common competency and professional consulting competency as a consultant. The common competency of school consultants includes communication, interpersonal relationship, synthetic thinking, utilization of information resources and technology, and self-management competency. The consulting competency consists of field specialty on school field and school education, process specialty for consulting principles and methodologies, and consulting ethics meaning confidentiality, sincerity, and autonomy in consulting. The communication competency of school consultant is classified as common competency, and consists of general communication and educational communication competency which has been derived from Schein’s consultation principles. The general communication competency includes writing, speaking, reading, and listening ability for effective delivery and understanding of messages, and discussion and moderation ability for narrowing the gap of opinions. The educational communication competency is composed of sub-factors that identify the purpose and content of communication based on Schein's consulting principles: 1) awareness of the importance of forming mutually helpful relationships and communication, 2) presentness of communication based on consultee’s now-here, 3) accuracy of communication, 4) awareness of the intervention influence, 5) consultee's agency and learning, 6) giving the consultee time to understand the situation and context and to provide feedback, 7) timeliness that captures important opportunities to increase the effectiveness of the intervention, 8) confronting intervention that changes the perspective of the consultee facing a constrained situation, 9) recognizing negative reactions and errors consultant's intervention and using them as data for effective consulting, 10) acknowledging the consultant's own limitations and sharing problem situations with consultee. This study is significant in developing a school consultants’ competency model and, in particular, deriving education communication competency, by identifying the educational meaning of communication in overall school consulting focusing on problem solving and consultant learning, which are the goals of Schein’s Process Consultation. However, this study could not deal with the whole competency of school consultant and has focused on the education communication competency, therefore, the relationships and complementary aspects with general communication competency, other common competency, and consulting competency, were not fully revealed.

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Агаева, A. Agaeva, Баурина i Svetlana Baurina. "Modern Consulting: Professional Consulting Problems". Economics of the Firm 5, nr 1 (10.03.2016): 49–51. http://dx.doi.org/10.12737/20811.

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This article is devoted to research of problems of professional consulting in the market of consulting services. The typical management problems are designated which are need to be solved by professional consultants. The typology of consultants in the market in the field of management consulting is considered.

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Koshy, Seena, Nour Ismail, Carmen Leon Astudillo, Christina Mallarino Haeger, Obadah Aloum, Mahesh Thalavitiya Acharige, Dimitrios Farmakiotis i in. "Breath-Based Diagnosis of Invasive Mucormycosis (IM)". Open Forum Infectious Diseases 4, suppl_1 (2017): S53—S54. http://dx.doi.org/10.1093/ofid/ofx162.124.

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Abstract Background Timely diagnosis of IM remains a major challenge in clinical mycology. Because of the lack of specific diagnostic methods for IM and the frequently fulminant nature of this infection, IM-associated mortality remains high. Methods We examined breath volatile metabolite profiles in a neutropenic murine model of IM, using the 3 Mucorales species that most commonly cause human IM - Rhizopus arrhizus var. arrhizus, R. arrhizus var. delemar, and R. microsporus - and for comparison, Aspergillus fumigatus. We infected female balb/c mice (N = 4 per group) treated with cyclophosphamide and cortisone followed by intranasal administration of 106 conidia of each species. 3 days post-infection, we collected breath samples from each mouse via tracheostomy using a flexiVent murine ventilator, examining breath volatile metabolites using thermal desorption gas chromatography/tandem mass spectrometry (GC-MS/MS). We also sampled breath prospectively from five patients eventually diagnosed with proven IM caused by R. microsporus, analyzing breath volatile metabolites using thermal desorption GC-MS/MS. Results Each Mucorales species produced a consistent profile of breath sesquiterpene secondary metabolite VOCs in our murine models, which distinguished these species from each other and from murine invasive aspergillosis (Figure A). These fungi shifted their secondary metabolism significantly in vivo, compared with their previously characterized in vitro metabolism. We found overlapping VOC sesquiterpene metabolites between breath samples from the murine model of R. microsporus infection and 5 of 5 patients with R. microsporus IM, with additional sesquiterpene secondary metabolites detected in patient breath, compared with the murine IM model (Figure B). In one patient with serial breath samples, these sesquiterpenes declined in abundance and disappeared with antifungal therapy, in parallel with clinical improvement (Figure C). Conclusion The three Mucorales species that cause most human IM have distinct breath sesquiterpene profiles that can be used to identify these infections in vivo noninvasively. These profiles distinguish these infections from each other and from aspergillosis, and may be useful in monitoring clinical response to treatment. Disclosures F. M. Marty, Astellas Pharma US: Consultant and Grant Investigator, Consulting fee and Grant recipient; Chimerix: Consultant and Grant Investigator, Consulting fee and Grant recipient; Fate Therapeutics: Scientific Advisor, Consulting fee; Gilead Sciences: Consultant and Grant Investigator, Consulting fee and Grant recipient; LFB: Consultant, Consulting fee; Merck: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Grant recipient; Roche Molecular Systems: Consultant, Consulting fee; Shire: Consultant and Grant Investigator, Consulting fee and Grant recipient; D. P. Kontoyiannis, Pfizer: Research Contractor, Research support and Speaker honorarium; Astellas: Research Contractor, Research support and Speaker honorarium; Merck: Honorarium, Speaker honorarium; Cidara: Honorarium, Speaker honorarium; Amplyx: Honorarium, Speaker honorarium; F2G: Honorarium, Speaker honorarium

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Grabowski, Wojciech, i Edward Stawasz. "Business consulting, knowledge absorptive capacity, and innovativeness: A triangular model for micro and small enterprises in Poland". Journal of Entrepreneurship, Management and Innovation 19, nr 1 (2023): 7–40. http://dx.doi.org/10.7341/20231911.

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PURPOSE: This paper proposes a triangular relationship between business consulting, knowledge absorptive capacity, and innovativeness. The role of knowledge absorptive capacity in stimulating the impact of business consulting on innovativeness is studied. METHODOLOGY: An empirical study is conducted using the CATI method, and it is based on data concerning 382 Polish micro and small enterprises. Qualitative variables reflecting using business consulting, knowledge absorptive capacity and innovativeness are defined. The multivariate discrete choice model taking into account relationships among these constructs, is proposed and its parameters are estimated. FINDINGS: The results of the empirical research indicate that business consulting in Poland and similar countries may help firms implement innovative solutions. Knowledge absorptive capacity stimulates innovativeness and has a positive impact on the relationship between using business consulting and improvement in innovativeness. Though the frequency of using business consulting is an important factor in improving innovativeness, cooperation between a consultant and a manager matters more. IMPLICATIONS: Results of the empirical research indicate that cooperation between a consultant and a manager may help reduce differences of opinion and internal conflicts. A higher propensity to cooperate may significantly improve the functioning of an enterprise. Business consulting has an indirect and direct effect on innovativeness. It has a positive impact on knowledge absorptive capacity, while better knowledge stimulates innovativeness. ORIGINALITY AND VALUE: An original triangular model of the relationship between business consulting, knowledge absorptive capacity, and innovativeness is proposed. Advanced econometric methods are used in order to find complex relationships between using business consulting, knowledge absorptive capacity, and improvement in innovativeness. Moreover, results of the estimation of the parameters of the econometric model provide interesting recommendations for policies supporting the development of business consulting in the Polish economy.

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Wohl, David, Anthony Mills, Robertino Mera i David Piontkowsky. "Selected CNS Outcomes Among INSTI Antiretrovirals". Open Forum Infectious Diseases 4, suppl_1 (2017): S39. http://dx.doi.org/10.1093/ofid/ofx162.094.

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Abstract Background Higher rates of neuropsychiatric events among patients on dolutegravir (DTG) compared with other integrase inhibitors (INSTIs) have been reported from clinic cohorts and one blinded trial. We compared select neurological and psychiatric events in a large sample of patients treated with different INSTIs. Methods The Quintiles IMS database, which includes pharmacy and medical claims records, was examined for HIV infected patients treated from 2006 to 2016 with DTG (TIVICAY/TRIUMEQ), elvitegravir (EVG, STRIBILD), or raltegravir (RAL, ISENTRESS). The dependent variable outcomes were insomnia/sleep disturbance and depression. A propensity score was created to adjust for variables associated with treatment with a particular INSTI including age, gender, year of initial INSTI exposure, and enrollment time. Multivariate Poisson mixed models were used to generate incidence rate ratios (IRRs). Results Records for 54,151 distinct HIV-infected patients treated with DTG, EVG, or RAL were identified. In the multivariate model the rate of insomnia/sleep disturbance events was significantly higher for patients treated with DTG vs. EVG (IRR 1.21 [95% CI 1.09–1.33, P < 0.001]), but was not significantly different when comparing DTG to RAL (IRR 1.04 [95% CI 0.94–1.14, P = 0.459]). Likewise, the rate of incident depression was significantly higher for patients treated with DTG vs. EVG (IRR 1.18 [95% CI 1.09–1.27, P < 0.001], but not when comparing DTG to RAL (IRR 0.93 [95% CI 0.87 – 1.01, P = 0.068]). Conclusion In this analysis using a large healthcare database, significantly higher adjusted rates of both incident insomnia/sleep disturbances (21% more) and depression (18% more) were found among patients treated with DTG compared with EVG. In contrast, a significant difference in the rates of either outcome was not observed when comparing DTG and RAL. Further studies are warranted to determine the risk of neuropsychiatric events in patients treated with different INSTIs. Disclosures D. Wohl, Gilead Sciences: Consultant and Investigator, Consulting fee and Research grant; Viiv: Consultant and Investigator, Consulting fee and Research grant; Janssen: Consultant, Consulting fee; Bristol-Myers Squibb: Consultant, Consulting fee; A. Mills, Gilead Sciences: Consultant, Investigator and Speaker’s Bureau, Consulting fee, Research grant and Speaker honorarium; Viiv: Consultant and Investigator, Consulting fee and Research grant; Merck: Consultant, Investigator and Speaker’s Bureau, Consulting fee, Research grant and Speaker honorarium; Janssen: Investigator, Research grant; Bristol-Myers Squibb: Investigator, Research grant; Sangamo Bio Sciences: Investigator, Research grant; R. Mera, Gilead Sciences: Employee and Shareholder, Salary; D. Piontkowsky, Gilead Sciences: Employee and Shareholder, Salary

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Саханский, Н., i N. Sakhanskiy. "Consulting Activity and Innovative Technologies of Its Organization in an Educational Institution". Profession-Oriented School 6, nr 1 (5.03.2018): 15–21. http://dx.doi.org/10.12737/psh_1_2018_2.

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The article describes the main innovative technology consulting activities, the benefi ts and features of their application. The author defi nes the role of the consultant in the use of innovative technologies and consulting activities in education.

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Herbison, Reyna, Therese F. Yaeger i Peter Sorensen. ""Meaningful Consulting: The Independent Consultant, Profiles and Possibilities"". Academy of Management Proceedings 2016, nr 1 (styczeń 2016): 10277. http://dx.doi.org/10.5465/ambpp.2016.10277abstract.

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Oh, Timothy S., James E. Peacock, Katherine Le, M. Rizwan Sohail, Larry M. Baddour, Holenarasipur R. Vikram, Jose M. Miro i in. "1085. Enterococcal Cardiac Implantable Electronic Device (CIED) Infections: Clinical Features and Outcomes". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S325. http://dx.doi.org/10.1093/ofid/ofy210.920.

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Abstract Background Unlike enterococcal native and prosthetic valve infective endocarditis (IE), enterococcal CIED infections are not well described. Methods Data from the Multicenter Electrophysiologic Device Infection Collaboration (MEDIC), a prospective, observational, multinational cohort study of CIED infections, were used to provide a descriptive analysis of adult patients with CIED infections due to enterococcal species. Results Of 433 patients, 21 (4.8%) were diagnosed with enterococcal CIED infection. Specific data on enterococcal species and antimicrobial susceptibilities were not recorded. The mean age was 70.8 years. No patient had previous CIED infection. Twelve patients (57%) had permanent pacemakers, 5 (24%) had implantable cardioverter defibrillators, and 4 (19%) had biventricular devices. Among the 21 infections, 3 (14%) were categorized as CIED-related bloodstream infections and 18 (86%) as IE; no patient had isolated pocket infection. Of the IE cases, four were valvular IE, eight were lead IE, and six were both. Fourteen cases of IE (78%) were definite by the modified Duke criteria. Median time from last device procedure to infection was 510 days (range 37–2,952 days). The most common presenting symptom was fever (48%); five patients (24%) exhibited local signs of pocket infection. All 21 patients underwent TEE with vegetations demonstrated in 17 (81%). Blood cultures grew enterococci from all patients. The most common antimicrobial regimen was a penicillin plus aminoglycoside (38%); two patients (9.5%) received ampicillin + ceftriaxone. Antibiotics were given for a median of 43 days. Only 14 patients (67%) had complete device removal; the seven patients retaining their device were judged to be at high risk for extraction. There was one death during the index hospital stay with four additional patients dying over the 6 months after therapy (overall mortality 24%); two of the seven patients retaining their CIED died. Conclusion Enterococci caused 4.8% of all CIED infections in our cohort. Most infections appeared to be hematogenous in origin with late onset. IE was the most common infectious syndrome. A penicillin plus aminoglycoside, given for 6 weeks, was the most frequent therapy. Only 67% of patients underwent device removal. At 6 months follow-up, no relapses had occurred but overall mortality was 24%. Disclosures J. E. Peacock Jr., Pfizer, Inc.: Shareholder, Owns common stock in Pfizer which was inherited and held in a trust. M. R. Sohail, TyRx Inc.: Investigator, Research support. Medtronic Inc.: Investigator, Research support. Medtronic Inc.: Consultant, Speaker honorarium. Spectranetics: Consultant, Speaker honorarium. Boston Scientific Corp: Consultant, Speaker honorarium. L. M. Baddour, UpToDate: Collaborator, Royalty payment. J. M. Miro, Abbvie: Consultant and Grant Investigator, Consulting honoraria and Research grant. Bristol-Myers Squibb: Consultant and Grant Investigator, Consulting honoraria and Research grant. Genentech: Consultant and Grant Investigator, Consulting honoraria and Research grant. Medtronic: Consultant and Grant Investigator, Consulting honoraria and Research grant. Novartis: Consultant and Grant Investigator, Consulting honoraria and Research grant. Gilead Sciences: Consultant and Grant Investigator, Consulting honoraria and Research grant. Pfizer: Consultant and Grant Investigator, Consulting honoraria and Research grant. ViiV Healthcare: Consultant and Grant Investigator, Consulting honoraria and Research grant. A. J. Greenspon, Medtronic: Consultant, Speaker honorarium. Boston Scientific: Consultant, Speaker honorarium. St. Jude: Consultant, Speaker honorarium. R. G. Carrillo, St. Jude Medical Group: Speaker’s Bureau, Research support. Spectranetics: Consultant, Speaker honorarium. Sorin Group: Speaker’s Bureau, None. Boston Scientific Corp: Speaker’s Bureau, None. D. Z. Uslan, Medtronic: Investigator, Research support. Boston Scientific: Consultant, Speaker honorarium.

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Mangushev, Dmytro V., i Nadiia M. Babenko. "The Importance of Consulting for the Ukrainian Market for Sales of New Passenger Cars". Business Inform 6, nr 545 (2023): 191–96. http://dx.doi.org/10.32983/2222-4459-2023-6-191-196.

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The article is aimed at studying managerial consulting as a business and an effective method of sales and profitability of a firm, considering the importance of consulting in the passenger car market. The difference between the terms «managerial consulting» and «consulting» is considered. The characteristic features of managerial consulting for enterprises are identified. Consulting is considered on the example of passenger car sales and their growth rates during 2018–2022. The article describes what problems specialists and companies face in their work. It is found which brands of cars and in what quantity were sold during the specified years. It was further considered which car brands were sold the most, especially for such public structures as the National Police of Ukraine, the Security Service of Ukraine, the Ministry of Justice of Ukraine, the State Forest Resources Agency of Ukraine, the State Bureau of Investigation of Ukraine, and the Foreign Intelligence Service of Ukraine, also purchase of cars by the aforementioned agencies in the terms of quantity and amount. The article analyzes which car brands according to Prozorro are among the five most popular in sales among government bodies. The article allocates the factors (political, economic, social, technological, ecological, etc.) to influence the managerial consulting and what exactly can influence a decision to buy a passenger car. The article describes what functions a consultant should perform in his work, and what skills in psychology the consultant should have a good command of. The prospects of development of managerial consulting in the future are allocated, taking into account the current trends.

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McGowan, Craig, Carmen Arriola, Charisse Nitura Cummings, Pam D. Kirley, Lisa Miller, James I. Meek, Evan J. Anderson i in. "Causes of In-hospital and Post discharge Mortality Among Patients Hospitalized with Laboratory-Confirmed Influenza, Influenza Hospitalization Surveillance Network, 2014–2015". Open Forum Infectious Diseases 4, suppl_1 (2017): S24. http://dx.doi.org/10.1093/ofid/ofx162.061.

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Abstract Background Influenza results in an estimated 12,000–56,000 deaths annually in the USA. While in-hospital deaths are well characterized, less is known about deaths that occur after discharge among those hospitalized with influenza. Methods We identified patients hospitalized with laboratory-confirmed influenza who died during hospitalization or within 30 days after discharge during the 2014–2015 influenza season for 11 Influenza Hospitalization Surveillance Network sites. We matched cases to the National Center for Health Statistics Electronic Death Registration System and abstracted cause and location of death from death certificates. We compared clinical characteristics between those who died during hospitalization and those who died after hospital discharge using χ2 tests. Results Among 795 patients with laboratory-confirmed influenza who died, 370 (47%) died during hospitalization, and 425 (53%) died within 30 days after discharge. Eighteen (2%) were 0–17 years and 652 (82%) were ≥65 years. Common causes of death listed in any position on the death certificate included influenza (35%), other respiratory causes (50%), cardiovascular disease (37%), and sepsis (15%). Among those who died after discharge, 207 (49%) died within 7 days, 86 (20%) within 8–14 days, and 132 (31%) within 15–30 days post discharge. Patients who died after discharge were more likely to be ≥65 years (88 vs. 74%) or admitted from a nursing home (48 vs. 36%), but were less likely to be admitted to an intensive care unit (30 vs. 68%) or receive a pneumonia diagnosis (46 vs. 62%) than patients who died during hospitalization (all P < 0.001). There were no significant differences in sex, race, underlying conditions, vaccination rates, or time from symptom onset to hospitalization. Patients who died in hospital were more likely to have influenza listed as a cause of death (55 vs. 21%, P < 0.01). Conclusion Over half of deaths among patients hospitalized with laboratory-confirmed influenza occurred after discharge. Patients who died after discharge were older and less likely to have influenza listed as a cause of death. Deaths that occur after an influenza-related hospitalization represent an important and under-characterized contribution to the burden of seasonal influenza. Disclosures E. J. Anderson, AbbVie: Consultant, Consulting fee; NovaVax: Research Contractor, Research support; Regeneron: Research Contractor, Research grant; MedImmune: Research Contractor, Research grant and Research support. W. Schaffner, Pfizer: Scientific Advisor, Consulting fee; Merck: Scientific Advisor, Consulting fee; Novavax: Consultant, Consulting fee; Dynavax: Consultant, Consulting fee; Sanofi-pasteur: Consultant, Consulting fee; GSK: Consultant, Consulting fee; Seqirus: Consultant, Consulting fee

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Jorgensen, Sarah, Evan J. Zasowski, Trang D. Trinh, Abdalhamid M. Lagnf, Sahil Bhatia i Michael J. Rybak. "1061. Comparison of the Acute Physiology and Chronic Health Evaluation (APACHE) II Score and the Pitt Bacteremia Score to Predict Mortality in Methicillin-Resistant Staphylococcus aureus Bacteremia". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S317—S318. http://dx.doi.org/10.1093/ofid/ofy210.898.

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Abstract Background Methicillin-resistant Staphylococcus aureus bloodstream infection (MRSA BSI) is associated with high morbidity and mortality. The prediction of outcomes may have a profound impact on clinical decision making and risk stratification. The Acute Physiology and Chronic Health Evaluation (APACHE) II Score and the Pitt Bacteremia Score (PBS) have been repeatedly described as independent predictors of mortality in MRSA BSI. The APACHE II is complex to calculate and many of the variables may not be pertinent to MRSA BSI. The PBS is a simple score using readily assessable variables. The comparative predictive performance of the two models in MRSA BSI has not been evaluated. Methods Retrospective, observational, singe-center cohort study in adults with MRSA BSI between 2008 and 2018. Patients who did not receive active therapy ≤72 hours of index culture were excluded. APACHE II and PBS were calculated using the worst physiological values recorded ≤24 hours of blood culture collection. Discriminatory ability for 30-day mortality was assessed using the c-statistic and was compared using the Hanley and McNeil method. The best cut-off point in each scoring system was determined using the Youden Index (J). Results A total of 455 patients were included. The median (IQR) PBS and APACHE II were 2 (0, 3) and 18 (11, 23), respectively. All-cause 30-day mortality was 16.3%. The c-statistic (95% CI) for the APACHE II vs. PBS in the overall cohort and stratified by ICU status were: 0.813 (0.763, 0.863) vs. 0.717 (0.653, 0.782), P = 0.0035; ICU 0.729 (0.610, 0.848) vs. 0.570 (0.442, 0.699), P = 0.026; and non-ICU 0.821 (0.761, 0.881) vs. 0.700 (0.614, 0.786),P = 0.0046, respectively. The APACHE II with the maximum J value was 21; sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for 30-day mortality were 81.08%, 72.97%, 36.81%, and 95.21%, respectively. The PBS with the maximum J value was 3; sensitivity, specificity, PPV, and NPV were 66.22%, 72.18%, 31.61%, and 91.67%, respectively. Conclusion The APACHE II was superior to the PBS in predicting 30-mortality in patients with MRSA BSI in the overall cohort and stratified by ICU status at BSI onset. Future research to develop a more practical scoring model with high discriminatory power is needed. Disclosures 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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Hanuláková, Eva, i Ina Kováčová Bečková. "Marketing as a Part of Strategic Management of Consulting Companies". Studia Commercialia Bratislavensia 9, nr 35 (1.12.2016): 266–77. http://dx.doi.org/10.1515/stcb-2016-0026.

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Abstract Consulting companies in order to be successful and to provide services at high professional level inevitably need clear strategy. They must have an established vision, following up on strategy that forms their way of development. Continuously changing area, strong competition, growing demands by the clients for professionally provided services with additional value and new technology represent key features that evoke necessity of use of marketing at the activity of consulting companies. At consulting companies, the marketing system has its particulars that are typical for consulting companies. The mentioned particulars regard mainly marketing mixture and the position of consultant.

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Саханский, Н., i N. Sakhanskiy. "Theoretical Bases of Consulting in Education". Profession-Oriented School 6, nr 2 (22.05.2018): 3–17. http://dx.doi.org/10.12737/article_5ae4698ece2634.80182219.

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In the article the theoretical bases of consulting in education are considered. The essence and content of counseling is given. The article defi nes the major types of counseling. The boundaries of the pedagogical counselling, the role and place of pedagogical counselling in the educational process are justifi ed. Core competencies of a consultant in education, principles of interaction between client and consultant are analyzed. The author defi nes the major types of consulting services in education.

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Lodise, Thomas P., Susan L. Rosenkranz, Matthew Finnemeyer, Jacqueline Huvane, Alenda Pereira, Matthew Sims, Marcus J. Zervos i in. "The Emperor’s New Clothes: Prospective Observational Evaluation of the Association between the Day 2 Vancomycin Exposure and Failure Rates among Adult Hospitalized Patients with MRSA Bloodstream Infections (PROVIDE)". Open Forum Infectious Diseases 4, suppl_1 (2017): S30—S31. http://dx.doi.org/10.1093/ofid/ofx162.074.

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Abstract Background Current guidelines recommend vancomycin (VAN) dosing to achieve AUC/MIC ratio ≥400 for patients (pts) with serious MRSA bloodstream infections (BSI), but supporting data were largely derived in single center retrospective studies. A recent study using a Bayesian approach to estimate the VAN AUC found that patients with MRSA BSI who had an AUCDAY2/MICBMD ≥ 650 or an AUCDAY2/MICETEST ≥ 320 had lower incidences of failure (Clin Infect Dis 59:666, 2014). This study prospectively evaluated if these VAN AUCDAY2/MIC targets were associated with lower incidences of failure (PROVIDE, Award number UM1AI104681, Antibacterial Resistance Leadership Group). Methods Prospective, multi-center (n = 14), observational study (2014–2106) of hospitalized adults with confirmed MRSA BSI treated with VAN ≥ 72h. Exclusion: (1) neutropenia; (2) cystic fibrosis; (3) renal replacement therapy; (4) APACHE-II score > 25; (5) previous MRSA BSI within 60 days. VAN exposures were estimated using maximum a posteriori probability procedure in ADAPT 5. MICBMD and MICETEST were performed at a central laboratory. Outcomes: failure (30-day mortality or MRSA BSI ≥ 7 days); acute kidney injury (AKI), ≥1.5 × increase in serum creatinine (Scr) among patients with a baseline SCR < 2.0mg/dl. The study was powered at 80% to detect a 17.5% difference in failure between AUCDAY2/MIC groups. Results Among the 265 evaluable patients, mean (SD) age was 61 (17) and APACHE-II was 12 (6). Endocarditis was definite/possible in 29%. The MIC50/90 by BMD and ETEST were 1/1 and 1.5/1.5mg/l, respectively. Failure occurred in 18%; 26% had AKI. Mean (SD) VAN duration was 18 (14) days. Mean (SD) AUCDAY2 was 586.9 (235.5) and 44% and 73% of patients achieved an AUCDAY2/MICBMD ≥ 650 and AUCDAY2/MICETEST ≥ 320. In the multivariate analyses (Figure 1), failure was not significantly different between AUCDAY2/MIC groups. In contrast, AKI was significantly more common in patients with an AUCDAY2/ MICETEST > = 320. Conclusion Achievement of higher VAN AUCDAY2/MIC exposures for patients with MRSA BSIs were not associated with better outcomes and were found to result in increased AKI. Clinicians should assess the benefits vs. risks of using VAN regimens that confer high AUCDAY2/MIC exposures for patients with MRSA BSIs. Disclosures T. P. Lodise Jr., allergan: Consultant, Grant Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium; medicines company: Consultant, Grant Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research support and Speaker honorarium; melinta: Consultant, Consulting fee; motif: Consultant and Scientific Advisor, Consulting fee; paratek: Consultant and Scientific Advisor, Consulting fee; nabriva: Consultant, Consulting fee; M. J. Zervos, Merck, Inc.: Investigator, Research grant; M. Scheetz, Bayer: Scientific Advisor, Consulting fee; V. Fowler Jr., Pfizer, Novartis, Galderma, Novadigm, Durata, Debiopharm, Genentech, Achaogen, Affinium, Medicines Co., Cerexa, Tetraphase, Trius, MedImmune, Bayer, Theravance, Cubist, Basilea, Affinergy, Janssen, xBiotech, Contrafect: Consultant, Consulting fee; NIH, Basilea, MedImmune, Cerexa/Forest/Actavis/Allergan, Pfizer, Advanced Liquid Logics, Theravance, Novartis, Cubist/Merck; Medical Biosurfaces; Locus; Affinergy; Contrafect; Karius: Grant Investigator, Research grant; Green Cross, Cubist, Cerexa, Durata, Theravance; Debiopharm: Consultant, Consulting fee; UpToDate: author on several chapters, Royalties

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Voight, Mike, i John Callaghan. "The Use of Sport Psychology Services at NCAA Division I Universities from 1998-1999". Sport Psychologist 15, nr 1 (marzec 2001): 91–102. http://dx.doi.org/10.1123/tsp.15.1.91.

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The purpose of this study is to provide information regarding the number of consulting positions offered by NCAA Division I universities. Questionnaires were administered to 115 NCAA Division I universities. An 84% return rate was achieved, totaling 96 universities. It was determined that 51 (53%) of the university athletic departments in the sample used some form of sport psychology consulting, whereas 45 (47%) departments reportedly did not use the services of a sport psychology consultant. Frequency reports of those questionnaires from universities who used sport psychology consulting services indicated 10 different sport psychology consultant positions; the most often used consultant positions consisted of the part-time consultants hired by individual sport programs (n = 19, 37%), followed by part-time consultants hired by the athletic departments (n = 10, 20%), then full-time consultants hired by the athletic departments (n = 7, 14%). Also reported are the reasons some athletic departments did not use the services of a sport psychology consultant.

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Soblirov, A. A. "Using network partnerships in management consulting". Vestnik Universiteta, nr 6 (27.07.2022): 56–64. http://dx.doi.org/10.26425/1816-4277-2022-6-56-64.

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The article discusses the use of network partnership in the process of interaction between the consultant and the client in the framework of the search, the client’s receipt of investments and further project support. Traditionally, the process of interaction between the client and the consultant is presented in such a way that only these two parties are the main participants in the consultation process. The article discusses the experience of building a multidisciplinary complex consulting process, in which many participants are involved. This experience is based on the practice of the Business Angels of Russia network community. This article analyses the practice of mainly small consulting organisations that are very different from large ones and provide significantly more customised services. The consulting related to investing funds in the client’s business is in the author’s focus. At the same time, only clients belonging to small and medium-sized enterprises naturally stand out in the work. As a rule, they do not seek advice from wellknown and renowned brands in the field of consulting services. As a rule, they do not have enough money for their services, and large consulting firms themselves choose mainly large clients to work with.

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Howe, William, Sally Vernon, William T. Vericker i Lois Zachary. "Consulting". Adult Learning 6, nr 1 (wrzesień 1994): 9–11. http://dx.doi.org/10.1177/104515959400600106.

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Burger, H. A. "Consulting". IEEE Potentials 15, nr 2 (1996): 25. http://dx.doi.org/10.1109/mp.1996.490050.

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Linton, Otha. "Consulting". Academic Radiology 11, nr 5 (maj 2004): 602. http://dx.doi.org/10.1016/j.acra.2004.01.007.

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Parks, Michael. "Consulting". Journal of Business Strategy 21, nr 1 (styczeń 2000): 10–11. http://dx.doi.org/10.1108/eb040052.

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Anthony, Winston, Bin Wang, Candice Cass, Tiffany Hink, Kimberly Reske, Sondra Seiler, Erik R. Dubberke, Carey-Ann D. Burnham, Gautam Dantas i Jennie H. Kwon. "1773. Impact of Antibiotics Used to Treat Community Acquired Pneumonia on the Gut Microbiome and Resistome in Healthy Volunteers". Open Forum Infectious Diseases 5, suppl_1 (listopad 2018): S66—S67. http://dx.doi.org/10.1093/ofid/ofy209.158.

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Abstract Background Antibiotics (ABX) are frequently inappropriately used to treat nonbacterial causes of respiratory illnesses. The goal of this prospective cohort study was to characterize the impact of ABX used to treat community-acquired pneumonia (CAP) on the fecal microbiome and resistome in healthy volunteers (HV). Methods Twenty HVs were randomized to receive 5 days of levofloxacin (LV), azithromycin (AZ), cefpodoxime (CF), or AZ+CF. Stool was collected before, during, and after ABX, then underwent microbiologic culture and shotgun sequencing. DNA was extracted, then sequenced using the Illumina NextSeq platform. Relative abundance of bacterial taxa was estimated by MetaPhlAn and antibiotic resistance gene (ARG) composition by ShortBRED. Analysis was in R. Results The mean HV age was 37 (range 24–59) and 10 were female. Species diversity measured via Shannon Index and richness were significantly lower in samples taken from all HVs 3 days post-ABX (P < 0.01 for all). While nonmetric multidimensional scaling (NDMS) ordination shows high interpatient dissimilarity (Bray–Curtis) for most samples, the post-ABX intrapatient dissimilarity varies by ABX. The AZ group exhibited chronic alterations in taxa dissimilarity and the CF group had increases in dissimilarity directly post-ABX. The CF+AZ group displayed both acute and persistent perturbations (Figure 1). Although there was no significant change in ARG richness post-ABX, there was a significant increase in overall ARG abundance across all samples (P < 0.003). Within each ABX, there were unique changes in ARG abundance, and groups with CF had increases in ARG abundance (Figure 2). Conclusion ABX used to treat CAP can cause acute microbiome disruptions, as evidenced by decreased microbiome species diversity and richness, and an increase in ARG abundance post-ABX. The duration of this impact is variable. To prevent microbiome disruptions, measures to prevent inappropriate ABX use via ABX stewardship are necessary. Disclosures E. R. Dubberke, Rebiotix: Consultant and Investigator, Consulting fee and Research support. Pfizer: Consultant and Grant Investigator, Consulting fee and Research grant. Synthetic biologics: Consultant, Consulting fee. Merck: Consultant and Investigator, Consulting fee and Research support. Valneva: Consultant, Consulting fee. Achaogen: Consultant, Consulting fee. Alere: webinar, Speaker honorarium. Biofire: webinar, Speaker honorarium.

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Kobayashi, Miwako, William Adih, Jianmin Li, Ryan Gierke, Olivia M. Almendares, James Watt, Nisha Alden i in. "Changes in invasive pneumococcal disease among adults living with HIV following introduction of 13-valent pneumococcal conjugate vaccine, 2008–2014". Open Forum Infectious Diseases 4, suppl_1 (2017): S57—S58. http://dx.doi.org/10.1093/ofid/ofx162.134.

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Abstract Background People living with HIV (PLHIV) are at increased risk of invasive pneumococcal disease (IPD). Introduction of 13-valent pneumococcal conjugate vaccine (PCV13) in children in 2010 reduced adult IPD burden (indirect effects). In 2012, PCV13 was recommended in series with 23-valent polysaccharide vaccine (PPSV23) for adults with immunocompromising conditions, including PLHIV. We evaluated changes in IPD incidence in adults ≥19 years old with and without HIV after PCV13 introduction for children in 2010 and for immunocompromised adults in 2012. PCV13 coverage for adults 19–64 years old with indications was 6% in 2014. Methods IPD cases, defined as pneumococcal isolation from sterile sites, were identified through CDC’s Active Bacterial Core surveillance, with counts projected nationally. HIV status was obtained from medical records. Isolates were serotyped by Quellung reaction or PCR and grouped into PCV13-types, PPV11-types (unique to PPSV23), or non-vaccine types. We estimated IPD incidence (cases per 100,000 people) using national case-based HIV surveillance (for PLHIV) or US Census data (for non-PLHIV) as denominators. We compared IPD incidence in 2011–12 and 2013–14 to the pre-PCV13 baseline (2008–09) by serotype groups. Results Overall IPD incidence at baseline was 354.0 for PLHIV and 15.5 for non-PLHIV. From baseline to 2013–14, IPD rates declined in both PLHIV (-36.3%; 95% CI: -38.8, -33.7%) and non-PLHIV (-27.3%; 95% CI: -28.2, -26.5%). The largest reductions were noted in PCV13-type IPD in both PLHIV (Figure 1) and non-PLHIV (Figure 2) for both periods (-46.8% for PLHIV and -45.9% for non-PLHIV in 2011–12; -60.3% for PLHIV and -65.8% for non-PLHIV in 2013–14). Overall IPD rates were 22.8 (95% CI: 22.2, 23.4) times as high in PLHIV compared with non-PLHIV at baseline, and 19.4 (95% CI: 18.8, 20.0) times as high in 2013–2014. Conclusion IPD rates declined significantly in both PLHIV and non-PLHIV during the study period due to reductions in PCV13-type IPD; however, IPD rates remained 20-fold in PLHIV compared with non-PLHIV. Similar magnitude reductions in PCV13-type IPD in both groups and low PCV13 coverage in immunocompromised adults suggest that most of the observed decline is due to PCV13 indirect effects from childhood immunization. Disclosures L. Harrison, GSK: Scientific Advisor, Consulting fee; W. Schaffner, Pfizer: Scientific Advisor, Consulting fee; Merck: Scientific Advisor, Consulting fee; Novavax: Consultant, Consulting fee; Dynavax: Consultant, Consulting fee; Sanofi-pasteur: Consultant, Consulting fee; GSK: Consultant, Consulting fee; Seqirus: Consultant, Consulting fee

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Pilishvili, Tamara, Ryan Gierke, Monica Farley, William Schaffner, Ann Thomas, Arthur Reingold, Lee Harrison i in. "Direct and Indirect Impact of 13-valent Pneumococcal Conjugate Vaccine (PCV13) on Invasive Pneumococcal Disease (IPD) Among Children and Adults in the U.S." Open Forum Infectious Diseases 4, suppl_1 (2017): S66—S67. http://dx.doi.org/10.1093/ofid/ofx162.158.

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Abstract Background In February 2010, PCV13 was introduced for routine use among children aged < 5 years. In June 2012, PCV13 was recommended for use in series with 23-valent polysaccharide vaccine (PPSV23) for adults ≥19 years with select medical conditions, and in August 2014, for all adults ≥65 years. We evaluated the direct and indirect effects of PCV13 6 years post-introduction on invasive pneumococcal disease (IPD). Methods IPD cases (isolation of pneumococcus from sterile sites) were identified among residents of Active Bacterial Core surveillance (ABCs) sites during July 2007–June 2016. Isolates were serotyped by Quellung, PCR, or whole genome sequencing and classified as PCV13 or non-vaccine type (NVT). Incidence changes were estimated as percent changes (one minus rate ratio) and 95% confidence intervals (95% CI) between pre-PCV13 (2007–2009) and two post-PCV13 periods (July 2014–June 2015 and July 2015–June 2016). Results ABCs identified 31,190 IPD cases between 2007 and 2015, with 2,750 cases among children <5 years and 10,930 among those ≥65 years. During the two post-PCV13 periods, overall IPD rates were 33%-62% lower relative to 2007–2009 among all age groups, including <5 years and ≥65 years (Figure). Significant reductions in PCV13-type IPD incidence were observed for all age groups during both post-PCV13 periods, with incidence 84% (q95% CI 78, 88%) and 68% (95% CI 63, 73%) lower in 2015–2016 among children < 5 years and adults ≥65 years, respectively. PCV13-type IPD reductions were driven by serotypes 19A and 7F. IPD due to non-vaccine types also declined significantly among children < 5 years (−27%, 95% CI –42, –9%) and adults ≥65 years (-24%, 95% CI –34, –14%). PCV13-type IPD incidence did not differ significantly between the two post-PCV13 periods. Conclusion IPD incidence declined among children and adults in the U.S. following PCV13 introduction among children. The lack of difference in PCV13 rates between 2014–2015 and 2015–2016 suggests no measurable early impact of PCV13 introduction among adults ≥65 years. To date, we found no evidence of significant replacement disease with non-PCV13 types. Further work is needed to explain reductions in non-vaccine type disease observed in the post-PCV13 era. Disclosures W. Schaffner, Pfizer: Scientific Advisor, Consulting fee; Merck: Scientific Advisor, Consulting fee; Novavax: Consultant, Consulting fee; Dynavax: Consultant, Consulting fee; Sanofi-pasteur: Consultant, Consulting fee; GSK: Consultant, Consulting fee; Seqirus: Consultant, Consulting fee; L. Harrison, GSK: Scientific Advisor, Consulting fee

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