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OBJECTIVE: To analyze the role of nosocomial infection informatics surveillance system in the prevention and control of multidrug-resistant organisms(MDROs) infections. METHODS: The First Affiliated Hospital of Guangdong Pharmaceutical University was selected as the study subjects, which had adopted the nosocomial infection informatics surveillance system since Jan.2020. The period of Jan.to Dec.2020 were regarded as the study period, and Jan.to Dec.2019 were regarded as the control period. The situation of nosocomial infection and MDROs infections in the two periods were retrospectively analyzed. RESULTS: The incidence of nosocomial infections and underreporting of nosocomial infection cases in this hospital during the study period were 2.52%(1 325/52 624) and 1.74%(23/1 325), respectively, and the incidences of ventilator associated pneumonia(VAP), catheter related bloodstream infection(CRBSI), catheter related urinary tract infection(CAUTI)were 4.10(31/7 568), 2.11(14/6 634), and 2.50(25/9 993) respectively, which were lower than those during the control period(P< 0.05). The positive rate of pathogenic examination in the hospital during the study period was 77.95%(1 269/1 628), which was higher than that during the control period(P<0.05), the overall detection rate of MDROs was 15.77%(206/1 306), the detection rates of MDROs in Escherichia coli, Acinetobacter baumannii, Klebsiella pneumoniae, Staphylococcus epidermidis, Pseudomonas aeruginosa and Staphylococcus aureus were lower than those during the control period(P<0.05). CONCLUSION: The development and application of the informatics technology-based surveillance system of nosocomial infection could effectively reduce the incidence of nosocomial infections and device related infections, decrease the under-reporting of infection cases, and also reduce the detection rate of MDROs as well as the proportion of MDROs detected in common pathogenic species.
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In this paper, we have mapped the coping methods used to address the coronavirus pandemic by members of the academic community. We conducted an anonymous survey of a convenient sample of 674 faculty/staff members and students from September to December 2020. A modified version of the RCOPE scale was used for data collection. The results indicate that both religious and existential coping methods were used by respondents. The study also indicates that even though 71% of informants believed in God or another religious figure, 61% reported that they had tried to gain control of the situation directly without the help of God or another religious figure. The ranking of the coping strategies used indicates that the first five methods used by informants were all non-religious coping methods (i.e., secular existential coping methods): regarding life as a part of a greater whole, regarding nature as an important resource, listening to the sound of surrounding nature, being alone and contemplating, and walking/engaging in any activities outdoors giving a spiritual feeling. Our results contribute to the new area of research on academic community's coping with pandemic-related stress and challenges.
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BackgroundComprehensive and large-scale assessment of health-related quality of life in patients with idiopathic inflammatory myopathies (IIMs) worldwide is lacking. The second COVID-19 vaccination in autoimmune disease (COVAD-2) study [1] is an international, multicentre, self-reported e-survey assessing several aspects of COVID-19 infection and vaccination as well as validated patient-reported outcome measures (PROMs) to outline patient experience in various autoimmune diseases (AIDs), with a particular focus on IIMs.ObjectivesTo investigate physical and mental health in a global cohort of IIM patients compared to those with non-IIM autoimmune inflammatory rheumatic diseases (AIRDs), non-rheumatic AIDs (NRAIDs), and those without AIDs (controls), using Patient-Reported Outcome Measurement Information System (PROMIS) global health data obtained from the COVAD-2 survey.MethodsDemographics, AID diagnoses, comorbidities, disease activity, treatments, and PROMs were extracted from the COVAD-2 database. The primary outcomes were PROMIS Global Physical Health (GPH) and Global Mental Health (GMH) scores. Secondary outcomes included PROMIS physical function short form-10a (PROMIS PF-10a), pain visual analogue scale (VAS), and PROMIS Fatigue-4a scores. Each outcome was compared between IIMs, non-IIM AIRDs, NRAIDs, and controls. Factors affecting GPH and GMH scores in IIMs were identified using multivariable regression analysis.ResultsA total of 10,502 complete responses from 1582 IIMs, 4700 non-IIM AIRDs, 545 NRAIDs, and 3675 controls, which accrued as of May 2022, were analysed. Patients with IIMs were older [59±14 (IIMs) vs. 48±14 (non-IIM AIRDs) vs. 45±14 (NRAIDs) vs. 40±14 (controls) years, p<0.001] and more likely to be Caucasian [82.7% (IIMs) vs. 53.2% (non-IIM AIRDs) vs. 62.4% (NRAIDs) vs. 34.5% (controls), p<0.001]. Among IIMs, dermatomyositis (DM) and juvenile DM were the most common (31.4%), followed by inclusion body myositis (IBM) (24.9%). Patients with IIMs were more likely to have comorbidities [68.1% (IIMs) vs. 45.7% (non-IIM AIRDs) vs. 45.1% (NRAIDs) vs. 26.3% (controls), p<0.001] including mental disorders [33.4% (IIMs) vs. 28.2% (non-IIM AIRDs) vs. 28.4% (NRAIDs) vs. 17.9% (controls), p<0.001].GPH median scores were lower in IIMs compared to NRAIDs or controls [13 (interquartile range 10–15) IIMs vs. 13 (11–15) non-IIM AIRDs vs. 15 (13–17) NRAIDs vs. 17 (15–18) controls, p<0.001] and PROMIS PF-10a median scores were the lowest in IIMs [34 (25–43) IIMs vs. 40 (34–46) non-IIM AIRDs vs. 47 (40–50) NRAIDs vs. 49 (45–50) controls, p<0.001]. GMH median scores were lower in AIDs including IIMs compared to controls [13 (10–15) IIMs vs. 13 (10–15) non-IIM AIRDs vs. 13 (11–16) NRAIDs vs. 15 (13–17) controls, p<0.001]. Pain VAS median scores were higher in AIDs compared to controls [3 (1–5) IIMs vs. 4 (2–6) non-IIM AIRDs vs. 2 (0–4) NRAIDs vs. 0 (0–2) controls, p<0.001]. Of note, PROMIS Fatigue-4a median scores were the highest in IIMs [11 (8–14) IIMs vs. 8 (10–14) non-IIM AIRDs vs. 9 (7–13) NRAIDs vs. 7 (4–10) controls, p<0.001].Multivariable regression analysis in IIMs identified older age, male sex, IBM, comorbidities including hypertension and diabetes, active disease, glucocorticoid use, increased pain and fatigue as the independent factors for lower GPH scores, whereas coexistence of interstitial lung disease, mental disorders including anxiety disorder and depression, active disease, increased pain and fatigue were the independent factors for lower GMH scores.ConclusionBoth physical and mental health are significantly impaired in patients with IIMs compared to those with non-IIM AIDs or those without AIDs. Our results call for greater attention to patient-reported experience and comorbidities including mental disorders to provide targeted approaches and optimise global well-being in patients with IIMs.Reference[1]Fazal ZZ, Sen P, Joshi M, et al. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int. 2022;42:2151–58.AcknowledgementsThe authors a e grateful to all respondents for completing the questionnaire. The authors also thank The Myositis Association, Myositis India, Myositis UK, the Myositis Global Network, Cure JM, Cure IBM, Sjögren's India Foundation, EULAR PARE for their contribution to the dissemination of the survey. Finally, the authors wish to thank all members of the COVAD study group for their invaluable role in the data collection.Disclosure of InterestsAkira Yoshida: None declared, Yuan Li: None declared, Vahed Maroufy: None declared, Masataka Kuwana Speakers bureau: Boehringer Ingelheim, Ono Pharmaceuticals, AbbVie, Janssen, Astellas, Bayer, Asahi Kasei Pharma, Chugai, Eisai, Mitsubishi Tanabe, Nippon Shinyaku, Pfizer, Consultant of: Corbus, Mochida, Grant/research support from: Boehringer Ingelheim, Ono Pharmaceuticals, Naveen Ravichandran: None declared, Ashima Makol Consultant of: Boehringer-Ingelheim, Parikshit Sen: None declared, James B. Lilleker: None declared, Vishwesh Agarwal: None declared, Sinan Kardes: None declared, Jessica Day Grant/research support from: CSL Limited, Marcin Milchert: None declared, Mrudula Joshi: None declared, Tamer A Gheita: None declared, Babur Salim: None declared, Tsvetelina Velikova: None declared, Abraham Edgar Gracia-Ramos: None declared, Ioannis Parodis Grant/research support from: Amgen, AstraZeneca, Aurinia Pharmaceuticals, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis, and F. Hoffmann-La Roche, Elena Nikiphorou Speakers bureau: Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly, Consultant of: Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly, Grant/research support from: Pfizer, Eli Lilly, Ai Lyn Tan Speakers bureau: AbbVie, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, UCB, Consultant of: AbbVie, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, UCB, Arvind Nune: None declared, Lorenzo Cavagna: None declared, Miguel A Saavedra Consultant of: AbbVie, GlaxoSmithKline, Samuel Katsuyuki Shinjo: None declared, Nelly Ziade Speakers bureau: AbbVie, Boehringer-Ingelheim, Eli Lilly, Janssen, Pfizer, Roche, Consultant of: AbbVie, Boehringer-Ingelheim, Eli Lilly, Janssen, Pfizer, Roche, Grant/research support from: AbbVie, Boehringer-Ingelheim, Eli Lilly, Janssen, Pfizer, Roche, Johannes Knitza: None declared, Oliver Distler Speakers bureau: AbbVie, Amgen, Bayer, Boehringer Ingelheim, Janssen, Medscape, Novartis, Consultant of: 4P-Pharma, AbbVie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, iQvia, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Prometheus, Redxpharma, Roivant, Sanofi, Topadur, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Kymera, Mitsubishi Tanabe, Novartis, Roche, Hector Chinoy Grant/research support from: Eli Lilly, UCB, Vikas Agarwal: None declared, Rohit Aggarwal Consultant of: Mallinckrodt, Octapharma, CSL Behring, Bristol Myers-Squibb, EMD Serono, Kezar, Pfizer, AstraZeneca, Alexion, Argenx, Boehringer Ingelheim (BI), Corbus, Janssen, Kyverna, Roivant, Merck, Galapagos, Actigraph, Abbvie, Scipher, Horizontal Therapeutics, Teva, Biogen, Beigene, ANI Pharmaceutical, Nuvig, Capella, CabalettaBio, Grant/research support from: Bristol Myers-Squibb, Pfizer, Mallinckrodt, Janssen, Q32, EMD Serono, Boehringer Ingelheim, Latika Gupta: None declared.
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BackgroundUpadacitinib (UPA) is an oral JAK inhibitor (JAKi) approved for the treatment of RA. JAKi have been associated with an elevated risk of herpes zoster (HZ) in patients (pts) with RA. The adjuvanted recombinant zoster vaccine (RZV, Shingrix) was shown to be well-tolerated and effective in preventing HZ in adults aged ≥ 50 years.[1] The efficacy and safety of RZV have not been studied in pts with RA while on UPA in combination with MTX.ObjectivesTo assess the immunogenicity of RZV in pts with RA receiving UPA 15 mg once daily (QD) with background MTX.MethodsEligible adults aged ≥ 50 years with RA enrolled in the ongoing SELECT-COMPARE phase 3 trial (NCT02629159) received two RZV doses, administered at the baseline and week (wk) 12 visits. Pts should have been on stable doses of UPA 15 mg QD and background MTX for ≥ 8 wks before the first vaccination and ≥ 4 wks after the second vaccination. Antibody titers were collected pre-vaccination (baseline), 4 wks post-dose 1 vaccination (wk 4), and 4 wks post-dose 2 vaccination (wk 16). The primary endpoint was the proportion of pts with a humoral response to RZV defined as ≥ 4-fold increase in pre-vaccination concentration of anti-glycoprotein E [gE] titer levels at wk 16. Secondary endpoints included humoral response to RZV at wk 4 and the geometric mean fold rise (GMFR) in anti-gE antibody levels at wks 4 and 16. Cell-mediated immunogenicity to RZV was an exploratory endpoint evaluated by the frequencies of gE-specific CD4+ [2+] T cells (CD4+ T cells expressing ≥ 2 of 4 activation markers: IFN-γ, IL-2, TNF-α, and CD40 ligand) measured by flow cytometry at wks 4 and 16 in a sub-cohort of pts.ResultsOf the 95 pts who received ≥ 1 RZV dose, 93 (98%) received both RZV doses. Pts had a mean (standard deviation) age of 62.4 (7.5) years. The median (range) disease duration was 11.7 (4.9–41.6) years and duration of UPA exposure was 3.9 (2.9–5.8) years. At baseline, all but 2 pts were receiving concomitant MTX and half (50%) were taking an oral corticosteroid (CS) at a median daily dose of 5.0 mg. One pt discontinued UPA by wk 16. Blood samples were available from 90/93 pts. Satisfactory humoral responses to RZV occurred in 64% (95% confidence interval [CI]: 55–74) of pts at wk 4 and 88% (81–95) at wk 16 (Figure 1). Age (50–< 65 years: 85% [95% CI: 75–94];≥ 65 years: 94% [85–100]) and concomitant CS (yes: 87% [77–97];no: 89% [80–98]) use at baseline did not affect humoral responses at wk 16. GMFR in anti-gE antibody levels compared with baseline values were observed at wks 4 (10.2 [95% CI: 7.3–14.3]) and 16 (22.6 [15.9–32.2]). Among the sub-cohort of pts, nearly two-thirds achieved a cell-mediated immune response to RZV (wk 4: n = 21/34, 62% [95% CI: 45–78];wk 16: n = 25/38;66% [51–81]). Within 30 days post-vaccination of either RZV dose, no serious adverse events (AEs) (Table 1) or HZ were reported. AEs that were possibly related to RZV were reported in 17% of pts. One death occurred more than 30 days after wk 16 due to COVID-19 pneumonia.ConclusionMore than three-quarters (88%) of pts with RA receiving UPA 15 mg QD on background MTX achieved a satisfactory humoral response to RZV at wk 16. In a subgroup of pts, two-thirds (66%) achieved a cell-mediated immune response to RZV at wk 16. Age and concomitant CS use did not negatively affect RZV response.Reference[1]Syed YY. Drugs Aging. 2018;35:1031–40.Table 1. Safety Results Through 30-Days Post-RZV Vaccination in UPA-Treated PatientsEvent, n (%)UPA 15 mg QD (N = 95)Any AE38 (40%)AE with reasonable possibility of being related to UPAa13 (14%)AE with reasonable possibility of being related to RZVa16 (17%)Severe AEb1 (1%)Serious AE0AE leading to discontinuation of UPA0Death0AE, adverse event;QD, once daily;RZV, adjuvanted recombinant zoster vaccine;UPA, upadacitinib.aAs assessed by the investigator.bHypersensitivity.AcknowledgementsAbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, review, and approval of the . All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Julia Zolotarjova, MSc, MWC, of AbbVie.Disclosure of InterestsKevin Winthrop Consultant of: AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, Gilead, GSK, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB, Grant/research support from: AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, Gilead, GSK, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB, Justin Klaff Shareholder of: AbbVie, Employee of: AbbVie, Yanxi Liu Shareholder of: AbbVie, Employee of: AbbVie, CONRADO GARCIA GARCIA: None declared, Eduardo Mysler Speakers bureau: AbbVie, Amgen, AstraZeneca, BMS, Eli Lilly, GlaxoSmithKline, Pfizer, Roche, and Sandoz, Consultant of: AbbVie, Amgen, AstraZeneca, BMS, Eli Lilly, GlaxoSmithKline, Pfizer, Roche, and Sandoz, Alvin F. Wells Consultant of: AbbVie, Amgen, BMS, Eli Lilly, Novartis, Pfizer, and Sanofi, Xianwei Bu Shareholder of: AbbVie, Employee of: AbbVie, Nasser Khan Shareholder of: AbbVie, Employee of: AbbVie, Michael Chen Shareholder of: AbbVie, Employee of: AbbVie, Heidi Camp Shareholder of: AbbVie, Employee of: AbbVie, Anthony Cunningham Consultant of: GSK, Merck Sharp & Dohme, and BioCSL/Sequirus.
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BackgroundUpadacitinib (UPA), a Janus kinase inhibitor, was effective and well tolerated in patients (pts) with non-radiographic axial spondyloarthritis (nr-axSpA) through 14 weeks (wks) of treatment.[1]ObjectivesThis analysis assessed the efficacy and safety of UPA vs placebo (PBO) through 1 year.MethodsThe SELECT-AXIS 2 nr-axSpA study included a 52-wk randomized, double-blind, PBO-controlled period. Enrolled adults had a clinical diagnosis of active nr-axSpA fulfilling the 2009 ASAS classification criteria, objective signs of inflammation based on MRI sacroiliitis and/or elevated C-reactive protein, and an inadequate response to NSAIDs. One-third of pts had an inadequate response to biologic DMARDs. Pts were randomized 1:1 to UPA 15 mg once daily or PBO. Concomitant medications, including NSAIDs, had to be kept stable through wk 52. The study protocol outlined that pts who did not achieve ASAS20 at any two consecutive study visits between wks 24 to 52 should receive rescue therapy with NSAIDs, corticosteroids, conventional synthetic/biologic DMARDs, or analgesics. Cochran-Mantel-Haenszel (CMH) test with non-responder imputation incorporating multiple imputation (NRI-MI) was used to handle missing data and intercurrent events for binary efficacy endpoints. Mixed-effect model repeated measures (MMRM) was used to assess continuous efficacy endpoints. NRI was used for binary endpoints after rescue and as observed analysis excluding data after rescue for continuous endpoints. Treatment-emergent adverse events (TEAEs) are reported through wk 52.ResultsOf the 314 pts randomized, 259 (82%;UPA, n=130;PBO, n=129) completed wk 52 on study drug. More pts achieved an ASAS40 response with UPA vs PBO from wks 14 to 52 with a 20% treatment difference at wk 52 (63% vs 43%;nominal P <.001;Figure 1). The proportion of pts achieving ASDAS inactive disease with UPA remained higher than PBO at wk 52 (33% vs 11%;nominal P <.0001;Figure 1). Consistent improvements and maintenance of efficacy were also seen across other disease activity measures. Between wks 24 and 52, fewer pts on UPA (9%) than PBO (17%) received rescue therapy. A similar proportion of pts in each treatment group had a TEAE (Table 1). Infections were the most common TEAE;the rates of serious infections and herpes zoster were higher with UPA vs PBO, although no new serious infections were reported from wks 14 to 52. COVID-19 events were balanced between treatment groups. No opportunistic infections, malignancy excluding non-melanoma skin cancer, adjudicated major adverse cardiovascular events, inflammatory bowel disease, or deaths were reported. Two pts (1.3%) on PBO had adjudicated venous thromboembolic events.ConclusionUPA showed consistent improvement and maintenance of efficacy vs PBO through 1 year across multiple disease activity measures. No new safety risks were identified with longer-term UPA exposure. These results continue to support the benefit of UPA in pts with active nr-axSpA.Reference[1]Deodhar A, et al. Lancet. 2022;400(10349):369–379.Table 1.Safety through week 52Event, n (%)PBO (n = 157)UPA 15 mg QD (n = 156)Any AE103 (66%)107 (69%)Serious AE6 (3.8%)6 (3.8%)AE leading to D/C4 (2.5%)6 (3.8%)COVID-19-related AE22 (14%)24 (15%)Deaths00Infection60 (38%)68 (44%) Serious infection1 (0.6%)2 (1.3%) Herpes zoster1 (0.6%)5 (3.2%)Malignancy other than NMSC00NMSC1 (0.6%)0Hepatic disorder7 (4.5%)6 (3.8%)Neutropenia1 (0.6%)8 (5.1%)MACE (adjudicated)00VTE (adjudicated)2 (1.3%)a0Uveitisb3 (1.9%)2 (1.3%)Inflammatory bowel disease00aBoth patients had non-serious events of deep vein thrombosis in the lower limb with risk factors including obesity and prior deep vein thrombosis in one patient and concomitant COVID-19 infection in the other patient.bThree events of uveitis occurred in each treatment group (among n = 3 patients in the PBO group and n = 2 patients in the UPA group);two events in the PBO group and one in the UPA group occurred in patients with a history of uveitis.AcknowledgementsAbbVie funded this study and participated in the study design, res arch, analysis, data collection, interpretation of data, review, and approval of the . All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Julia Zolotarjova, MSc, MWC, of AbbVie.Disclosure of InterestsFilip van den Bosch Speakers bureau: AbbVie, Amgen, Galapagos, Janssen, Lilly, Merck, MoonLake, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Amgen, Galapagos, Janssen, Lilly, Merck, MoonLake, Novartis, Pfizer, and UCB., Atul Deodhar Consultant of: AbbVie, Amgen, Aurinia, BMS, Celgene, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, GSK, Lilly, Novartis, Pfizer, and UCB, Denis Poddubnyy Speakers bureau: AbbVie, Biocad, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, MSD, Medscape, MoonLake, Novartis, Peervoice, Pfizer, Roche, Samsung Bioepis, and UCB, Consultant of: AbbVie, Biocad, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, MSD, Medscape, MoonLake, Novartis, Peervoice, Pfizer, Roche, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Lilly, MSD, Novartis, and Pfizer., Walter P Maksymowych Consultant of: AbbVie, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Novartis, Pfizer, and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, and UCB, Employee of: Director of Imaging Rheumatology BV, Tae-Hwan Kim Speakers bureau: AbbVie, Celltrion, Kirin, Lilly, and Novartis., Mitsumasa Kishimoto Consultant of: AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Chugai, Daiichi Sankyo, Eisai, Gilead, Janssen, Lilly, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, and UCB., Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB, Consultant of: AbbVie, BMS, Chugai, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie and Novartis, Yuanyuan Duan Shareholder of: AbbVie, Employee of: AbbVie, Kristin D'Silva Shareholder of: AbbVie, Employee of: AbbVie, Peter Wung Shareholder of: AbbVie, Employee of: AbbVie, In-Ho Song Shareholder of: AbbVie, Employee of: AbbVie.
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[...]we want to ensure that the potential participant understands the study, especially the risks and benefits. [...]paper consent increases the patient burden of participating in trials, requiring more time and travel. [...]our team is now better prepared to review documents, ensure accuracy, and seamlessly file a patient's information.
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(20171 purported that "increased nursing education enrolments to cater for possible future nursing shortages, (ii) decreased state expenditure on health services and, (iii) graduate employment dictated by staff vacancies rather than ensuring sustainability of the future workforce" (p. 251) are contributing factors. Sample and Data Collection Convenience sampling technique was used, and to ensure sufficient data sampling, two cohorts of graduating students were Invited to participate. The online survey data collection Incorporated closed and opened ended questions about participant engagement with the profession of nursing. All study participants, including the graduates with a previous Diploma of Nursing, provided a 100% response rate to their intention to register with the Nursing and Midwifery Board as a registered nurse (RN).
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PurposeThe purpose of this research is to develop through a two-stage verification and validation process a novel implementation framework for collaborative BIM, utilising experts from academia and industry as well as a real-world case study project.Design/methodology/approachThe aim of this research was to build upon previous research findings by the authors in order to develop an implementation framework that stems from ousting the inefficiencies of current collaborative BIM practices. This is achieved by a more objectified and quantified approach towards seeking heightened transparency and objectivism of what is required through the implementation of BIM. The mixed research methods technique of both qualitative and quantitative data collection was utilised, with the structure consisting of a two-stage approach utilising the Delphi model for verification and validation. This was developed to test the novelty and beneficial structure hypothesis involving 15 core BIM experts from academia, construction and design with c. 22 years average experience. Validation was undertaken on a complex, high value real world building structures project in central London, inclusive of 8 core project BIM experts. The research utilised a developed solution that mirrored and provided a more holistic representation guiding the practitioners as a project team step by step through the determination of underpinning elements, which support the goal of enhanced information requirements as well as executing the prioritisation measurement tools as part of the framework. Data ascertained at the workshop case study prioritised areas of importance that are core in supporting the delivering of these enhanced information requirements at a project delivery level, which were in order of prioritisation determined by the project team (1) constraints (39.17%), (2) stakeholder requirements (35.78%), (3) coordination (existing asset) (15.86%), (4) exchange requirements (5.38%) and (5) level of information need (3.81%). Furthermore, risk mitigations for the top three priorities were focussed on early stakeholder engagement, appropriation of survey data collection, focus on quality of outputs and applying toolsets and processes with meaning and emphasis on the defined high-level requirements.FindingsFindings show that the framework and the developed solution translate the process methodology of the framework schema into a useable and beneficial tool that provides both qualitative and quantitative inputs and outputs. Furthermore, a collective agreement on the objectives, risk mitigations and assignment of tasks in order to achieve outcomes is presented, with evidence on numerical weightings and goal achievement.Research limitations/implicationsDue to the impacts of COVID-19 on physical engagements both the verification (electronic survey questionnaire) and validation (case study project) were undertaken remotely, using available technologies and web interfaces.Practical implicationsThe case study workshop was limited to one building structures project in central London of a value of c. £70 m design and build cost that the project team (participants) were actively engaged with.Social implicationsThe social impacts of this research has resulted in the review of existing systems, methods and approaches from a wider perspective of theoretical and applied environments, which led to the development of a novel approach and framework guided by an interactive and useable solution.Originality/valueAs shown within the core findings, experts across academia and industry (design and construction) confirmed that the framework methodology and application were 100% novel, and added a benefit to the existing collaborative BIM approach. Value added is that through objectifying, weighting/prioritizing and creating a discussion supported by qualitative and quantitative reasoning the focus on what collaborative BIM is to achieve is increased, and thus the likelihood of successful implementation.
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[...]while the scientific panel notes with satisfaction that "research and innovation have been one of the few bright spots" in the COVID response, with "unprecedented advancements in record time," it laments the lack of a global strategy at the outset of the crisis "to optimize and coordinate research and development efforts." Countries need to have more capacities for data collection and analysis, including thorough genome sequencing for early detection, pathogen characterization, surveillance of pathogen spread, and assessment of disease dynamics. [...]the ideas are formally backed by G20 countries, heads of international and regional organizations, and representatives of global health bodies, after co-hosting by European Commission President Ursula von der Leyen and Italian Prime Minister Mario Draghi.
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Each student selected books during the last week of school and during the last days of the summer program, so that they had access to books when school was not in session. Since book ownership is an important motivator for reading, the students kept their books and were treated to one additional book on the last day of the program, when they took a field trip to a bookstore. Study Design Reallocating school resources required a research focus with data collection and analysis for continued approval of summer program funding. The mixed-methods design of the study included quantitative data (e.g., registration, attendance, STAR reading scores, Likert scale questions on student and parent questionnaires) and qualitative data (e.g., student focus groups, open-ended questions on student and parent questionnaires). Parents' written consent and students' assent were provided for STAR reading, focus group, and questionnaire data collection each summer.
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A variety of patient care and intelligent health systems can benefit from the implementation of artificial intelligence as a tool to aid caregivers. Machine learning and deep learning are two types of AI that are increasingly being used in the medical industry. Artificial intelligence methods require a large amount of clinical data from a range of imaging modalities for correct disease diagnosis. In addition, AI has greatly enhanced the quality of hospital stays, allowing patients to be released sooner and complete their recoveries at home. This article aims to provide the information on the field of AI subset i.e., machine learning-based disease detection with information that will aid them in making better decision making. This helps the researchers to classify the medical conditions in patients with a prominent dataset.
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BackgroundUpadacitinib (UPA) improved symptoms in patients (pts) with psoriatic arthritis (PsA) with prior inadequate response or intolerance to ≥1 non-biologic disease-modifying antirheumatic drug (nbDMARD-IR) through week (wk) 104 or 2 years of treatment in SELECT-PsA 1 [1].ObjectivesTo evaluate efficacy and safety of UPA vs adalimumab (ADA) through wk 152 or 3 years from the ongoing long-term open-label extension of SELECT-PsA 1.MethodsPts were randomized to receive UPA 15 mg (UPA15) or UPA 30 mg (UPA30) once daily, ADA 40 mg (ADA) every other wk, or placebo (PBO). At wk 24, PBO pts switched to UPA15 or UPA30. Following approval of UPA15, the protocol was amended so pts on UPA30 switched to UPA15 (earliest at wk 104). Efficacy was assessed through wk 152, and safety through June 13, 2022.ResultsOf 1704 pts randomized, 911 completed 152 wks of treatment. The proportions of pts achieving.≥20%/50%/70% improvement in American College of Rheumatology criteria (ACR20/50/70), minimal disease activity (MDA), and ≥75%/90%/100% improvement in Psoriasis Area and Severity Index at wk 152 were generally consistent with those at wk 1041. UPA had greater ACR20/50/70 and MDA responses vs ADA, and a greater mean change from baseline (BL) in Health Assessment Questionnaire-Disability Index, pt's assessment of pain, and Bath Ankylosing Spondylitis Disease Activity Index vs ADA. Change from BL in modified total Sharp/van der Heijde score were similar between UPA30 and ADA, and numerically higher with UPA15 (Table 1). The overall UPA safety profile remained unchanged (Figure 1) [1,2]. UPA had numerically higher rates of serious infection (SI), herpes zoster (HZ), anemia, lymphopenia, creatine phosphokinase (CPK) elevation, and non-melanoma skin cancer (NMSC) vs ADA. Increases for SI, HZ, anemia, and CPK elevation with UPA were dose dependent. Rates of major adverse cardiovascular events, venous thromboembolism, and malignancy excluding NMSC were low and generally similar across groups. The most common cause of death was COVID-19.ConclusionEfficacy of UPA in nbDMARD-IR pts with PsA was maintained through 3 years of treatment. No new safety signals were identified.References[1]McInnes IB, et al. Rheumatol Ther 2022;1–18 [Epub ahead of print].[2]McInnes IB, et al. RMD Open 2021;7(3):e001838.Table 1.Efficacy endpoints at wk 152UPA15 (n=429)UPA30a (n=423)ADA (n=429)Proportion of pts (%)NRIAONRIAONRIAOACR20/50/7064.6/52.0/35.9*89.8/71.6/ 48.263.1/54.1*/ 35.787.9/74.4/ 47.861.1/46.6/ 28.786.2/65.2/ 39.8Minimal disease activity37.555.143.5*60.335.950.2PASI75/90/100b50.5/42.5/32.269.2/58.5/ 43.458.1/46.7/3 7.678.6/63.5/ 50.954.0/40.8/ 30.379.6/59.9/ 44.6Resolution of enthesitis by Leeds Enthesitis Indexc50.475.248.973.846.077.0Resolution of dactylitis by Leeds Dactylitis Indexd65.495.266.197.965.497.1Change from BLeMMRMAOMMRMAOMMRMAOHealth Assessment Questionnaire- Disability Index-0.51-0.55-0.53*-0.58-0.45-0.49Pt's assessment of pain (numeric rating scale)-3.3*-3.5-3.3*-3.6-2.8-3.0Bath Ankylosing Spondylitis Disease Activity Indexf-3.09-3.27-3.16-3.54-2.81-2.71Modified total Sharp/van der Heijde score0.210.190.050.040.090.09aFollowing a protocol amendment, all pts on UPA30 switched to UPA15 (earliest switch at wk 104);data are presented by originally randomized group. bPts with psoriasis affecting ≥3% of body surface area at BL. cPts with LEI >0 at BL;resolution LEI=0. dPts with LDI >0 at BL;resolution LDI=0. eData shown as MMRM (least squares mean) and AO (mean). fPts with psoriatic spondylitis at BL. n value ranges: UPA15 (99–429), UPA30 (95–423), ADA (89–429). Nominal *p<0.05 UPA vs ADA.ACR20/50/70, ≥20%/50%/70% improvement in American College of Rheumatology criteria;ADA, adalimumab;AO, as observed;BL, baseline;MMRM, mixed effect model repeated measurement;NRI, non-responder imputation;PASI75/90/100, ≥75%/90%/100% improvement in Psoriasis Area and Severity Index;pt, patient;UPA15/30, upadacitinib 15/30 mg once daily;wk, weekAcknowledgementsAbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Carl Davies, MSc, of 2 the Nth (Cheshire, UK), and was funded by AbbVie.Disclosure of InterestsIain McInnes Grant/research support from: AbbVie, AstraZeneca, Bristol Myers Squibb, Celgene, Eli Lilly, Evelo, Causeway Therapeutics, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, and UCB Pharma, Koji Kato Employee of: AbbVie and may hold stock or options, Marina Magrey Consultant of: BMS, Eli Lilly, Janssen, Novartis, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Amgen, BMS, and UCB Pharma, Joseph F. Merola Consultant of: AbbVie, Arena, Avotres, Biogen, Bristol Myers Squibb, Celgene, Dermavant, Eli Lilly, EMD Sorono, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB Pharma, Mitsumasa Kishimoto Consultant of: AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Celgene, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, and UCB Pharma, Derek Haaland Speakers bureau: AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, Grant/research support from: AbbVie, Adiga Life Sciences, Amgen, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, UCB;and has received honoraria or other fees from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, and UCB Pharma, Yihan Li Employee of: AbbVie and may hold stock or options, Yanxi Liu Employee of: AbbVie and may hold stock or options, Jianzhong Liu Employee of: AbbVie and may hold stock or options, Ralph Lippe Employee of: AbbVie and may hold stock or options, Peter Wung Employee of: AbbVie and may hold stock or options.
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Digital technologies that could meet these new challenges and aid manufacturing scale-up and speed to market, such as automated digital data collection and augmented and virtual reality (AR/VR) remote collaboration tools, were already available and had been adopted by some, but the new demand spurred greater adoption. "There is a cultural aspect to digitalization because it's a significant investment that results in changes to the operational structure of a facility;it is beneficial when the digitalization comes from the top," explains Yvonne Duckworth, automation engineer and Industry 4.0 subject matter expert at the CRB Group, a life sciences engineering and construction company. Machine sensors and process analytical technology (PAT) instruments can communicate directly with data collection systems using the NoT. Efficient development and tech transfer for mRNA vaccine manufacturing The data analysis and clear communication allowed by digital tools has demonstrated its benefits for process development and technical transfer, making time to market faster.
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[...]international collaboration increased, and as part of this international exchange, formal work-sharing initiatives and dialogue emerged;there is a strong desire to use the pandemic response's flexibility and innovation to address unmet needs in other disease areas. [...]decentralized clinical trials (DCTs) have emerged quickly and are here to stay. DCTs will bring new challenges, such as ensuring appropriate training and delivery across sites and improving data collection and management. [...]new approaches are solidified, drug development will use proven methods.
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FDA also explained that system designs and controls should allow for detecting errors, omissions, and unusual results-outcomes that cannot be easily identified with paper-based processes. Because the guidance requirements for record retention and review don't differ between paper or electronic, this update supports the shift to a digital model. Using paper to check and mark things off is a normal practice in life sciences, even if it is not a very good process for error detection, data collection, or metrics, says Bryony Borneo, quality assurance director at global contract research organization (CRO) Emmes. Building a solid data foundation and gaining more experience with remote ways of working are driving positive change and making it easier for quality teams to remain compliant with regulations. According to Sanjeev Kumar, senior director, data integrity and technology at Vertex Pharmaceuticals, there is greater awareness of data standardization to identify developing trends and insights from information.
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BackgroundPatients with immune-mediated rheumatic diseases (IRD) have poorer outcomes of SARS-CoV-2 infection compared to the general population.ObjectivesTo assess and compare clinical course, severity and complications of SARS-CoV-2 infection in patients with rheumatic immune-mediated inflammatory diseases (IMIDs) from Mexico and Argentina.MethodsData from both national registries, CMR-COVID (Mexico) and SAR-COVID (Argentina), were combined. Briefly, adult IRD patients with SARS-CoV-2 infection were recruited between 08.2020 and 09.2022 in SAR-COVID and between 04.2020 and 06.2022 in CMR-COVID. Sociodemographic data, comorbidities, and DMARDs were recorded, as well as clinical characteristics, complications, and treatment for SARS-CoV-2 infection. Descriptive analysis. Chi square, Fisher, Student T, Mann Whitney U tests and multiple logistic regression analyses were performed.ResultsA total of 3709 patients were included, 1167 (31.5%) from the CMR-COVID registry and 2542 (68.5%) from the SAR-COVID registry. The majority (82.3%) were women, with a mean age of 50.4 years (SD 14.4). The most frequent IRD were rheumatoid arthritis (47.5%) and systemic lupus erythematosus (18.9%). Mexican patients were significantly older, had a higher female predominance and had higher prevalence of rheumatoid arthritis, antiphospholipid syndrome, and axial spondyloarthritis, while the Argentine patients had more frequently psoriatic arthritis and ANCA-associated vasculitis. In both cohorts, approximately 80% were in remission or low disease activity at the time of infection. Mexicans took glucocorticoids (43% vs 37%, p<0.001) and rituximab (6% vs 3%, p<0.001) more frequently. They also reported more comorbidities (48% vs 43%, p=0.012).More than 90% of patients presented symptoms related to SARS-CoV-2 infection. The frequency of hospitalization was comparable between the groups (23.4%), however, the Mexicans had more severe disease (Figure 1) and a higher mortality rate (9.4% vs 4.0%, p<0.0001). After adjusting for risk factors, Mexicans were more likely to die due to COVID-19 (OR 2.2, 95%CI 1.5-3.1).ConclusionIn this cohort of patients with IRD from Mexico and Argentina with SARS-CoV-2 infection, the majority presented symptoms, a quarter were hospitalized and 6% died due to COVID-19. Mexicans presented more severe disease, and after considering risk factors they were two times more likely to die.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsCarolina Ayelen Isnardi Grant/research support from: SAR-COVID is a multi- sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or infuenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database, Deshire Alpizar-Rodriguez: None declared, Marco Ulises Martínez-Martínez: None declared, Rosana Quintana: None declared, Ingrid Eleonora Petkovic: None declared, Sofia Ornella: None declared, Vanessa Viviana Castro Coello: None declared, Edson Velozo: None declared, David Zelaya: None declared, María Severina: None declared, Adriana Karina Cogo: None declared, Romina Nieto: None declared, Dora Aida Pereira: None declared, Iris Jazmin Colunga-Pedraza: None declared, Fedra Irazoque-Palazuelos: None declared, GRETA CRISTINA REYES CORDERO: None declared, Tatiana Sofía Rodriguez-Reyne: None declared, JOSE ANTONIO VELOZ ARANDA: None declared, Cassandra Michele Skinner Taylor: None declared, INGRID MARIBEL JUAREZ MORA: None declared, Beatriz Elena Zazueta Montiel: None declared, Atzintli Martínez: None declared, Cesar Francisco Pacheco Tena: None declared, Guillermo Pons-Estel: None declared.
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ObjectiveTo explore Young Persons (YP) and healthcare professionals (HCP) experiences of virtual consultations (VC) and establish whether developmentally appropriate healthcare can be delivered virtually.MethodYP and HCP questionnaire surveys were designed and piloted. Electronic questionnaire links were sent by post, email or text message January–April 2021 to YP aged 13–25 years old, with predefined chronic gastrointestinal conditions, attending a gastroenterology/hepatology VC. HCP undertaking VC were invited to complete staff questionnaire. Results were anonymous and collated using Excel version 2302.ResultsFive UK hospital trusts participated, with 35 HCP responses. Of the 100 YP completing the survey 66% were female and 34% male aged between 13 years and 25 years (median: 18 years). 13% were new appointments and 87% follow ups, 29% were by video, 69% by phone and 2% gave no response. 80% of HCP spoke to YP directly but not privately (69%). 87% of YP and 88% HCP found VC useful. 83% of YP want VC again, although 20% preferred face to face. 43% of HCP required improved phone/internet connection. 77% of YP required hospital appointments for tests following VC.ConclusionsOverall respondents were satisfied with VC, finding them useful, convenient and time saving. Successful VC rely on appropriate patient selection and availability of reliable technology. Patient preference is key which may alter with time.
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Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency Effective and efficient clinical data collection and management is one of the key factors affecting clinical trial success and is of heightened importance during the COVID-19 pandemic.1 Not only have the scope and complexity of clinical trials continued to increase over the past decade, but the volume and diversity of clinical study data grows ever larger. Researchers have accelerated the development of vaccines and therapeutics for COVID-19 as evidenced by the 4,846 trials found on clinicaltrials. gov.2 The COVID-19 pandemic presents a unique opportunity for understanding technologies that can enable trial data management and their effects on streamlining;and expediting clinical trial design and implementation. Specific measurements evaluated in this study were: database build efficiency, velocity of data collection, frequency of protocol amendments on the database, and the time impact of mid-study updates to the database. [...]the ability to execute mid-study updates or post-go live changes with minimal to no downtime (< one hour) allowed the users and sponsors to work in parallel rather than in serial fashion, speeding up trial start dates and implementation of protocol amendments, and accommodating adaptive COVID-19 trial design.
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Humans can be said to be social creatures who always cannot be separated from communicating with other humans. This study aims to determine the influence that can attract tourists to continue to visit and feel satisfied with the facilities provided. This research method is quantitative research, the type of data needed in this research is primary data and secondary data, the source of the data used in this study is by distributing questionnaires (questionnaires), the data collection technique used in this study is through the Likert scale. The results of the study show that this Jaddih Hill tour has utilized good electronic media, so that tourists are interested in visiting again besides tourists who visit have a sense of security and calm.
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This study investigated consumer behaviors in conspicuous omni-signaling—its internal motivations and its consequences on social needs fulfilment and re-consumption intention in the context of luxury fashion. A phenomenon of conspicuous consumption is identified with the consumption and display of conspicuous goods to signal status, wealth, and prestige. Digital development has made conspicuous signaling radically emerge in social media through the posting of photos, videos, or stories of luxury goods. This drives an emerging phenomenon of conspicuous omni-signaling, the use of both offline and online media to signal conspicuous consumption hybridlike. As a new phenomenon, little is known of consumer behaviors related to conspicuous omni-signaling. To facilitate the investigation, an online survey was conducted to collect data from 474 valid respondents across eight cities representing various conspicuous consumption characteristics of Indonesian consumers. Veblen's conspicuous consumption and Maslow's hierarchy of needs theories were employed as the main lens for analysis. PLS-SEM technique was employed as the research model uses mixed reflective and formative constructs. WarpPLS 7.0 was then used for data analysis. The results indicated that luxury values and fashion consciousness positively affect conspicuous omni-signaling. This study also found that conspicuous omni-signaling affects conspicuous re-consumption both directly and indirectly through social needs fulfilment. This study contributes to extend the concept of conspicuous offline consumption and conspicuous online consumption to conspicuous omni-signaling. This study also confirms conflicting results in the effect of conspicuous consumption on social needs fulfilment, and conflicting results in the effect of conspicuous consumption on conspicuous re-consumption.