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  • Open Access
    Authors: 
    Gehan Soosaipillai; Anjui Wu; Gino M Dettorre; Nikolaos Diamantis; John Chester; Charlotte Moss; Juan Aguilar-Company; Mark Bower; Christopher CT Sng; Ramon Salazar; +76 more
    Publisher: SAGE Publications
    Countries: Spain, United Kingdom
    Project: WT

    COVID-19; Cancer; End-of life care (EOLC) COVID-19; Cáncer; Cuidados al final de la vida COVID-19; Càncer; Cures al final de la vida Background: Specialist palliative care team (SPCT) involvement has been shown to improve symptom control and end-of-life care for patients with cancer, but little is known as to how these have been impacted by the COVID-19 pandemic. Here, we report SPCT involvement during the first wave of the pandemic and compare outcomes for patients with cancer who received and did not receive SPCT input from multiple European cancer centres. Methods: From the OnCovid repository (N = 1318), we analysed cancer patients aged ⩾18 diagnosed with COVID-19 between 26 February and 22 June 2020 who had complete specialist palliative care team data (SPCT+ referred; SPCT− not referred). Results: Of 555 eligible patients, 317 were male (57.1%), with a median age of 70 years (IQR 20). At COVID-19 diagnosis, 44.7% were on anti-cancer therapy and 53.3% had ⩾1 co-morbidity. Two hundred and six patients received SPCT input for symptom control (80.1%), psychological support (54.4%) and/or advance care planning (51%). SPCT+ patients had more ‘Do not attempt cardio-pulmonary resuscitation’ orders completed prior to (12.6% versus 3.7%) and during admission (50% versus 22.1%, p < 0.001), with more SPCT+ patients deemed suitable for treatment escalation (50% versus 22.1%, p < 0.001). SPCT involvement was associated with higher discharge rates from hospital for end-of-life care (9.7% versus 0%, p < 0.001). End-of-life anticipatory prescribing was higher in SPCT+ patients, with opioids (96.3% versus 47.1%) and benzodiazepines (82.9% versus 41.2%) being used frequently for symptom control. Conclusion: SPCT referral facilitated symptom control, emergency care and discharge planning, as well as high rates of referral for psychological support than previously reported. Our study highlighted the critical need of SPCTs for patients with cancer during the pandemic and should inform service planning for this population. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Wellcome Trust Strategic Fund [PS3416] awarded to DJP and by direct project funding from the NIHR Imperial Biomedical Research Centre (BRC) awarded to DJP. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. OnCovid was supported in part by funds from the Cancer Treatment and Research Trust (CTRT) awarded to DJP and from the Associazione Italiana per la Ricerca sul Cancro Foundation [14230] awarded to AG.

  • Open Access English
    Authors: 
    Steve Simpson-Yap; Edward De Brouwer; Tomas Kalincik; Nick Rijke; J. Hillert; Clare Walton; Gilles Edan; Yves Moreau; Tim Spelman; Lotte Geys; +37 more
    Publisher: Wolters Kluwer Health
    Countries: Belgium, United Kingdom

    Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Esclerosi múltiple Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Esclerosis múltiple Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Multiple Sclerosis Background and Objectives People with multiple sclerosis (MS) are a vulnerable group for severe coronavirus disease 2019 (COVID-19), particularly those taking immunosuppressive disease-modifying therapies (DMTs). We examined the characteristics of COVID-19 severity in an international sample of people with MS. Methods Data from 12 data sources in 28 countries were aggregated (sources could include patients from 1–12 countries). Demographic (age, sex), clinical (MS phenotype, disability), and DMT (untreated, alemtuzumab, cladribine, dimethyl fumarate, glatiramer acetate, interferon, natalizumab, ocrelizumab, rituximab, siponimod, other DMTs) covariates were queried, along with COVID-19 severity outcomes, hospitalization, intensive care unit (ICU) admission, need for artificial ventilation, and death. Characteristics of outcomes were assessed in patients with suspected/confirmed COVID-19 using multilevel mixed-effects logistic regression adjusted for age, sex, MS phenotype, and Expanded Disability Status Scale (EDSS) score. Results Six hundred fifty-seven (28.1%) with suspected and 1,683 (61.9%) with confirmed COVID-19 were analyzed. Among suspected plus confirmed and confirmed-only COVID-19, 20.9% and 26.9% were hospitalized, 5.4% and 7.2% were admitted to ICU, 4.1% and 5.4% required artificial ventilation, and 3.2% and 3.9% died. Older age, progressive MS phenotype, and higher disability were associated with worse COVID-19 outcomes. Compared to dimethyl fumarate, ocrelizumab and rituximab were associated with hospitalization (adjusted odds ratio [aOR] 1.56, 95% confidence interval [CI] 1.01–2.41; aOR 2.43, 95% CI 1.48–4.02) and ICU admission (aOR 2.30, 95% CI 0.98–5.39; aOR 3.93, 95% CI 1.56–9.89), although only rituximab was associated with higher risk of artificial ventilation (aOR 4.00, 95% CI 1.54–10.39). Compared to pooled other DMTs, ocrelizumab and rituximab were associated with hospitalization (aOR 1.75, 95% CI 1.29–2.38; aOR 2.76, 95% CI 1.87–4.07) and ICU admission (aOR 2.55, 95% CI 1.49–4.36; aOR 4.32, 95% CI 2.27–8.23), but only rituximab was associated with artificial ventilation (aOR 6.15, 95% CI 3.09–12.27). Compared to natalizumab, ocrelizumab and rituximab were associated with hospitalization (aOR 1.86, 95% CI 1.13–3.07; aOR 2.88, 95% CI 1.68–4.92) and ICU admission (aOR 2.13, 95% CI 0.85–5.35; aOR 3.23, 95% CI 1.17–8.91), but only rituximab was associated with ventilation (aOR 5.52, 95% CI 1.71–17.84). Associations persisted on restriction to confirmed COVID-19 cases. No associations were observed between DMTs and death. Stratification by age, MS phenotype, and EDSS score found no indications that DMT associations with COVID-19 severity reflected differential DMT allocation by underlying COVID-19 severity. Discussion Using the largest cohort of people with MS and COVID-19 available, we demonstrated consistent associations of rituximab with increased risk of hospitalization, ICU admission, and need for artificial ventilation and of ocrelizumab with hospitalization and ICU admission. Despite the cross-sectional design of the study, the internal and external consistency of these results with prior studies suggests that rituximab/ocrelizumab use may be a risk factor for more severe COVID-19. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article. The operational costs linked to this study are funded by the Multiple Sclerosis International Federation (MSIF) and the Multiple Sclerosis Data Alliance (MSDA), acting under the umbrella of the European Charcot Foundation. The MSDA receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Canopy Growth Corp, Genzyme, Icometrix, Merck, Mylan, Novartis, QMENTA, Quanterix, and Roche. MSIF receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Genzyme, Med-Day, Merck, Mylan, Novartis, and Roche. This work was supported by the Flemish government under the Onderzoeksprogramma Artificiële Intelligentie Vlaanderen programme and the Research Foundation Fladers (FWO) for ELIXIR Belgium–Flanders (FWO) for ELIXIR Belgium. The central platform was provided by QMENTA, and the computational resources used in this work were provided by Amazon. The statistical analysis was carried out at CORe, The University of Melbourne, with support from the National Health and Medical Research Council (NHMRC; 1129189 and 1140766).

  • Open Access English
    Authors: 
    Azambuja, Evandro de; Trapani, Dario; Loibl, Sibylle; Delaloge, Suzette; Senkus, Elzbieta; Criscitiello, Carmen; Poortman, Philip; Gnant, Michael; Di Cosimo, Serena; Cortés, Javier; +4 more
    Publisher: BMJ
    Countries: Belgium, Belgium, Spain

    The global preparedness and response to the rapid escalation to severe acute respiratory syndrome coronavirus (SARS-CoV)-2-related disease (COVID-19) to a pandemic proportion has demanded the formulation of a reliable, useful and evidence-based mechanism for health services prioritisation, to achieve the highest quality standards of care to all patients. The prioritisation of high value cancer interventions must be embedded in the agenda for the pandemic response, ensuring that no inconsistency or discrepancy emerge in the health planning processes. The aim of this work is to organise health interventions for breast cancer management and research in a tiered framework (high, medium, low value), formulating a scheme of prioritisation per clinical cogency and intrinsic value or magnitude of benefit. The public health tools and schemes for priority setting in oncology have been used as models, aspiring to capture clinical urgency, value in healthcare, community goals and fairness, while respecting the principles of benevolence, non-maleficence, autonomy and justice. We discuss the priority health interventions across the cancer continuum, giving a perspective on the role and meaning to maintain some services (undeferrable) while temporarily abrogate some others (deferrable). Considerations for implementation and the essential link to pre-existing health services, especially primary healthcare, are addressed, outlining a framework for the development of effective and functional services, such as telemedicine. The discussion covers the theme of health systems strategising, and why oncology care, in particular breast cancer care, should be maintained in parallel to pandemic control measures, providing a pragmatic clinical model within the broader context of public healthcare schemes. info:eu-repo/semantics/published SCOPUS: re.j

  • Open Access English
    Authors: 
    Askarian, Mehrdad; Semenov, Aleksandr; Llopis, Ferran; Rubulotta, Francesca; Dragovac, Gorana; Pshenichnaya, Natalia; Assadian, Ojan; Ruch, Yvon; Shayan, Zahra; Padilla Fortunatti, Cristobal; +26 more
    Countries: Belgium, Switzerland

    The aim of this study was to investigate the COVID-19 vaccination acceptance rate and its determinants among healthcare workers in a multicenter study. This was a cross-sectional multi-center survey conducted from February 5 to April 29, 2021. The questionnaire consisted of 26 items in 6 subscales. The English version of the questionnaire was translated into seven languages and distributed through Google Forms using snowball sampling; a colleague in each country was responsible for the forward and backward translation, and also the distribution of the questionnaire. A forward stepwise logistic regression was utilized to explore the variables and questionnaire factors tied to the intention to COVID-19 vaccination. 4630 participants from 91 countries completed the questionnaire. According to the United Nations Development Program 2020, 43.6 % of participants were from low Human Development Index (HDI) regions, 48.3 % high and very high, and 8.1 % from medium. The overall vaccination hesitancy rate was 37 %. Three out of six factors of the questionnaire were significantly related to intention to the vaccination. While ���Perceived benefits of the COVID-19 vaccination��� (OR: 3.82, p-value<0.001) and ���Prosocial norms��� (OR: 5.18, p-value<0.001) were associated with vaccination acceptance, ���The vaccine safety/cost concerns��� with OR: 3.52, p-value<0.001 was tied to vaccination hesitancy. Medical doctors and pharmacists were more willing to take the vaccine in comparison to others. Importantly, HDI with OR: 12.28, 95 % CI: 6.10-24.72 was a strong positive determinant of COVID-19 vaccination acceptance. This study highlighted the vaccination hesitancy rate of 37 % in our sample among HCWs. Increasing awareness regarding vaccination benefits, confronting the misinformation, and strengthening the prosocial norms would be the primary domains for maximizing the vaccination coverage. The study also showed that the HDI is strongly associated with the vaccination acceptance/hesitancy, in a way that those living in low HDI contexts are more hesitant to receive the vaccine. EXCLI Journal; 21:Doc93; ISSN 1611-2156

  • Open Access
    Authors: 
    Isabel Baenas; Mikel Etxandi; Lucero Munguía; Roser Granero; Gemma Mestre-Bach; Isabel Sánchez; Emilio Ortega; Alba Andreu; Violeta L. Moize; Jose-Manuel Fernández-Real; +55 more
    Publisher: MDPI AG
    Countries: Lithuania, Belgium, Portugal, Italy, France, Belgium, Spain, Italy
    Project: EC | PRIME (847879), EC | Eat2beNICE (728018)

    Background. The COVID-19 lockdown has had a significant impact on mental health. Patients with eating disorders (ED) have been particularly vulnerable. Aims. (1) To explore changes in eating-related symptoms and general psychopathology during lockdown in patients with an ED from various European and Asian countries; and (2) to assess differences related to diagnostic ED subtypes, age, and geography. Methods. The sample comprised 829 participants, diagnosed with an ED according to DSM-5 criteria from specialized ED units in Europe and Asia. Participants were assessed using the COVID-19 Isolation Scale (CIES). Results. Patients with binge eating disorder (BED) experienced the highest impact on weight and ED symptoms in comparison with other ED subtypes during lockdown, whereas individuals with other specified feeding and eating disorders (OFSED) had greater deterioration in general psychological functioning than subjects with other ED subtypes. Finally, Asian and younger individuals appeared to be more resilient. Conclusions. The psychopathological changes in ED patients during the COVID-19 lockdown varied by cultural context and individual variation in age and ED diagnosis. Clinical services may need to target preventive measures and adapt therapeutic approaches for the most vulnerable patients. We thank CERCA Programme/Generalitat de Catalunya for institutional support. This manuscript and research was supported by grants from the Department of Health of the Generalitat de Catalunya by the call Pla estratègic de recerca i innovació en salut (PERIS, SLT006/17/00077), the Ministerio de Economía y Competitividad (PSI201568701R), Fondo de Investigación Sanitario (FIS) (INT19/00046, PI17/01167, PI20/132), CIBERINFEC (CB21/13/00009) and co-funded by FEDER funds /European Regional Development Fund (ERDF), a way to build Europe (Eat2beNICE/ H2020-SFS-2016-2; Ref 728018; and PRIME/ H2020-SC1-BHC-2018-2020; Ref: 847879). CIBEROBN, CIBERSAM, CIBERINFEC and CIBERDEM are all initiatives of Instituto de Salud Carlos III (ISCIII). GMB is supported by a postdoctoral grant from FUNCIVA. PPM was supported, in part, by a Portuguese Foundation for Science and Technology grant (POCI-01-0145-FEDER-028145). IB was partially supported by a Post-Residency Grant from the Research Committee of the University Hospital of Bellvitge (HUB; Barcelona, Spain) 2020–2021. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. Fondo Investigacion Sanitario-FIS, Grant/Award Numbers: FIS, INT19/00046, PI17/01167; Ministerio de Economia y Competitividad, Grant/Award Number: PSI2015-68701-R; Portuguese Foundation for Science and Technology grant, Grant/Award Number: POCI-01-0145-FEDER-028145; Consejo Nacional de Ciencia y Tecnologia; Generalitat de Catalunya; European Regional Development Fund. Data Availability Statement: Individuals may inquire with Fernández-Aranda regarding availability of the data as there is ongoing studies using the data. To avoid overlapping research efforts, Fernández-Aranda will consider a request on a case-by-case basis.

  • Open Access English
    Authors: 
    Paul Hofman; M. Ilié; E. Chamorey; P. Brest; R. Schiappa; V. Nakache; M. Antoine; M. Barberis; H. Begueret; F. Bibeau; +70 more
    Publisher: Elsevier BV
    Countries: France, Italy, Slovenia, Italy, Italy, Belgium, France, Netherlands, France, Germany ...

    Background This study evaluated the consequences in Europe of the COVID-19 outbreak on pathology laboratories orientated toward the diagnosis of thoracic diseases. Materials and methods A survey was sent to 71 pathology laboratories from 21 European countries. The questionnaire requested information concerning the organization of biosafety, the clinical and molecular pathology, the biobanking, the workload, the associated research into COVID-19, and the organization of education and training during the COVID-19 crisis, from 15 March to 31 May 2020, compared with the same period in 2019. Results Questionnaires were returned from 53/71 (75%) laboratories from 18 European countries. The biosafety procedures were heterogeneous. The workload in clinical and molecular pathology decreased dramatically by 31% (range, 3%-55%) and 26% (range, 7%-62%), respectively. According to the professional category, between 28% and 41% of the staff members were not present in the laboratories but did teleworking. A total of 70% of the laboratories developed virtual meetings for the training of residents and junior pathologists. During the period of study, none of the staff members with confirmed COVID-19 became infected as a result of handling samples. Conclusions The COVID-19 pandemic has had a strong impact on most of the European pathology laboratories included in this study. Urgent implementation of several changes to the organization of most of these laboratories, notably to better harmonize biosafety procedures, was noted at the onset of the pandemic and maintained in the event of a new wave of infection occurring in Europe. Highlights • Biosafety measures used in the first wave of the COVID-19 crisis were heterogeneous in 53 European pathology laboratories. • A dramatic decrease of the workload in pathology laboratories was noted. • No case of healthcare workers contaminated with SARS-CoV-2 associated with samples handling was identified.

  • Open Access
    Authors: 
    Steve Simpson-Yap; Ashkan Pirmani; Tomas Kalincik; Edward De Brouwer; Lotte Geys; Tina Parciak; Anne Helme; Nick Rijke; Jan A. Hillert; Yves Moreau; +35 more
    Country: Belgium

    COVID-19; Severe acute respiratory syndrome; Data set COVID-19; Síndrome respiratorio agudo severo; Conjunto de datos COVID-19; Síndrome respiratòria aguda severa; Conjunt de dades Background and Objectives Certain demographic and clinical characteristics, including the use of some disease-modifying therapies (DMTs), are associated with severe acute respiratory syndrome coronavirus 2 infection severity in people with multiple sclerosis (MS). Comprehensive exploration of these relationships in large international samples is needed. Methods Clinician-reported demographic/clinical data from 27 countries were aggregated into a data set of 5,648 patients with suspected/confirmed coronavirus disease 2019 (COVID-19). COVID-19 severity outcomes (hospitalization, admission to intensive care unit [ICU], requiring artificial ventilation, and death) were assessed using multilevel mixed-effects ordered probit and logistic regression, adjusted for age, sex, disability, and MS phenotype. DMTs were individually compared with glatiramer acetate, and anti-CD20 DMTs with pooled other DMTs and with natalizumab. Results Of 5,648 patients, 922 (16.6%) with suspected and 4,646 (83.4%) with confirmed COVID-19 were included. Male sex, older age, progressive MS, and higher disability were associated with more severe COVID-19. Compared with glatiramer acetate, ocrelizumab and rituximab were associated with higher probabilities of hospitalization (4% [95% CI 1–7] and 7% [95% CI 4–11]), ICU/artificial ventilation (2% [95% CI 0–4] and 4% [95% CI 2–6]), and death (1% [95% CI 0–2] and 2% [95% CI 1–4]) (predicted marginal effects). Untreated patients had 5% (95% CI 2–8), 3% (95% CI 1–5), and 1% (95% CI 0–3) higher probabilities of the 3 respective levels of COVID-19 severity than glatiramer acetate. Compared with pooled other DMTs and with natalizumab, the associations of ocrelizumab and rituximab with COVID-19 severity were also more pronounced. All associations persisted/enhanced on restriction to confirmed COVID-19. Discussion Analyzing the largest international real-world data set of people with MS with suspected/confirmed COVID-19 confirms that the use of anti-CD20 medication (both ocrelizumab and rituximab), as well as male sex, older age, progressive MS, and higher disability are associated with more severe course of COVID-19. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: the operational costs linked to this study are funded by the Multiple Sclerosis International Federation (MSIF) and the Multiple Sclerosis Data Alliance (MSDA), acting under the umbrella of the European Charcot Foundation (ECF). The MSDA receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Canopy Growth Corporation, Genzyme, Icometrix, Merck, Mylan, Novartis, QMENTA, Quanterix, and Roche. MSIF receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Genzyme, Med-Day, Merck, Mylan, Novartis, and Roche. This work was supported by the Flemish Government under the Onderzoeksprogramma Artificiële Intelligentie (AI) Vlaanderen programme and the Research Foundation Fladers (FWO) for ELIXIR Belgium—Flanders (FWO) for ELIXIR Belgium. The central platform was provided by QMENTA, and the computational resources used in this work were provided by Amazon. The statistical analysis was carried out at CORe, The University of Melbourne, with support from NHMRC (1129189 and 1140766).

  • Publication . Article . Other literature type . Preprint . 2022
    Open Access English
    Authors: 
    Emma B. Hodcroft; Robert Dyrdak; Cristina Andrés; Adrian Egli; Josiane Reist; Diego García-Martínez de Artola; Julia Alcoba Florez; Hubert G. M. Niesters; Andrés Antón; Randy Poelman; +4 more
    Publisher: Public Library of Science
    Countries: Netherlands, Switzerland, Belgium, Switzerland

    BackgroundWorldwide outbreaks of enterovirus D68 (EV-D68) in 2014 and 2016 have caused serious respiratory and neurological disease.MethodsWe collected samples from several European countries during the 2018 out-break and determined 53 near full-length genome (‘whole genome’) sequences. These sequences were combined with 718 whole genome and 1,987 VP1-gene publicly available sequences.FindingsIn 2018, circulating strains clustered into multiple subgroups in the B3 and A2 subclades, with different phylogenetic origins. Clusters in subclade B3 emerged from strains circulating primarily in the US and Europe in 2016, though some had deeper roots linking to Asian strains, while clusters in A2 traced back to strains detected in East Asia in 2015-2016. In 2018, all sequences from the USA formed a distinct subgroup, containing only three non-US samples. Alongside the varied origins of seasonal strains, we found that diversification of these variants begins up to 18 months prior to the first diagnostic detection during a EV-D68 season. EV-D68 displays strong signs of continuous antigenic evolution and all 2018 A2 strains had novel patterns in the putative neutralizing epitopes in the BC- and DE-loops. The pattern in the BC-loop of the USA B3 subgroup had not been detected on that continent before. Patients with EV-D68 in subclade A2 were significantly older than patients with a B3 subclade virus. In contrast to other subclades, the age distribution of A2 is distinctly bimodal and was found primarily among children and in the elderly.InterpretationWe hypothesize that EV-D68’s rapid evolution of surface proteins, extensive diversity, and high rate of geographic mixing could be explained by substantial reinfection of adults.FundingUniversity of Basel and Swedish Foundation for Research and Development in Medical Microbiology

  • Open Access English
    Authors: 
    Gaël Dos Santos; Hao Wang; Pooja Jindal; Maria Rybo; Hélène Roul; Sridevi Pallem; Tamara Eckermann; Lode Godderis; Xavier Martínez Gómez; Eric Godard; +4 more
    Publisher: Springer Healthcare
    Country: Belgium

    Infectious disease; Influenza; Vaccine safety Enfermedad infecciosa; Gripe; Seguridad de las vacunas Malaltia infecciosa; Grip; Seguretat de les vacunes Introduction Seasonal influenza poses a major public health burden worldwide. Influenza vaccines, updated yearly to match circulating strains based on World Health Organization (WHO) recommendations, are the cornerstone of prevention and require regular monitoring. The COVID-19 pandemic is expected to cause logistical, site access and medical staff constraints and could affect the safety profile of influenza vaccines. Methods Following European Medicines Agency guidance, an enhanced safety surveillance (ESS) study assessed the frequency and severity of predefined and other adverse events (AEs) occurring within 7 days of receiving GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4), in Belgium, Germany and Spain in 2020/21, using adverse drug reaction (ADR) cards. Results During the 2020/21 influenza season, 1054 participants vaccinated with GSK’s IIV4 were enrolled (all adults in Belgium and Germany, 30% adults/70% children in Spain); 96 eligible children received a second dose. Overall, 1042 participants completed the study. After doses 1 and 2, 98.9% and 100% of participants, respectively, returned their completed ADR card. After doses 1 and 2, 37.8% (398/1054) and 13.5% (13/96) of participants, respectively, reported at least one AE. The most frequently reported categories of AEs were “general disorders and administration site conditions” (e.g. injection site pain) and “nervous system disorders” (e.g. headache). There were no deaths or serious AEs deemed related to GSK’s IIV4. Conclusion This ESS study assessed AEs in near real time. The COVID-19 pandemic did not alter the safety profile of GSK’s IIV4. No safety signals were detected during the study, which confirms the excellent safety profile of GSK’s IIV4. GlaxoSmithKline Biologicals SA funded this study (study number 207750) and was involved in all stages of the study, including analysis of the data. GlaxoSmithKline Biologicals SA also took charge of all costs associated with the development and publication of this present manuscript, including the Journal’s Rapid Service Fee.

  • Open Access
    Authors: 
    Concetta Elisa Onesti; Hope S. Rugo; Daniele Generali; Marc Peeters; Khalil Zaman; Hans Wildiers; Nadia Harbeck; Miguel Martin; Massimo Cristofanilli; Javier Cortes; +15 more
    Countries: Belgium, Italy, Belgium, Belgium, Belgium, Netherlands, Belgium, Belgium, Italy, United States ...

    Background COVID-19 appeared in late 2019, causing a pandemic spread. This led to a reorganisation of oncology care in order to reduce the risk of spreading infection between patients and healthcare staff. Here we analysed measures taken in major oncological units in Europe and the USA. Methods A 46-item survey was sent by email to representatives of 30 oncological centres in 12 of the most affected countries. The survey inquired about preventive measures established to reduce virus spread, patient education and processes employed for risk reduction in each oncological unit. Results Investigators from 21 centres in 10 countries answered the survey between 10 April and 6 May 2020. A triage for patients with cancer before hospital or clinic visits was conducted by 90.5% of centres before consultations, 95.2% before day care admissions and in 100% of the cases before overnight hospitalisation by means of phone calls, interactive online platforms, swab test and/or chest CT scan. Permission for caregivers to attend clinic visits was limited in many centres, with some exceptions (ie, for non-autonomous patients, in the case of a new diagnosis, when bad news was expected and for terminally ill patients). With a variable delay period, the use of personal protective equipment was unanimously mandatory, and in many centres, only targeted clinical and instrumental examinations were performed. Telemedicine was implemented in 76.2% of the centres. Separated pathways for COVID-19-positive and COVID-19-negative patients were organised, with separate inpatient units and day care areas. Self-isolation was required for COVID-19-positive or symptomatic staff, while return to work policies required a negative swab test in 76.2% of the centres. Conclusion Many pragmatic measures have been quickly implemented to deal with the health emergency linked to COVID-19, although the relative efficacy of each intervention should be further analysed in large observational studies. info:eu-repo/semantics/published SCOPUS: ar.j

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25 Research products, page 1 of 3
  • Open Access
    Authors: 
    Gehan Soosaipillai; Anjui Wu; Gino M Dettorre; Nikolaos Diamantis; John Chester; Charlotte Moss; Juan Aguilar-Company; Mark Bower; Christopher CT Sng; Ramon Salazar; +76 more
    Publisher: SAGE Publications
    Countries: Spain, United Kingdom
    Project: WT

    COVID-19; Cancer; End-of life care (EOLC) COVID-19; Cáncer; Cuidados al final de la vida COVID-19; Càncer; Cures al final de la vida Background: Specialist palliative care team (SPCT) involvement has been shown to improve symptom control and end-of-life care for patients with cancer, but little is known as to how these have been impacted by the COVID-19 pandemic. Here, we report SPCT involvement during the first wave of the pandemic and compare outcomes for patients with cancer who received and did not receive SPCT input from multiple European cancer centres. Methods: From the OnCovid repository (N = 1318), we analysed cancer patients aged ⩾18 diagnosed with COVID-19 between 26 February and 22 June 2020 who had complete specialist palliative care team data (SPCT+ referred; SPCT− not referred). Results: Of 555 eligible patients, 317 were male (57.1%), with a median age of 70 years (IQR 20). At COVID-19 diagnosis, 44.7% were on anti-cancer therapy and 53.3% had ⩾1 co-morbidity. Two hundred and six patients received SPCT input for symptom control (80.1%), psychological support (54.4%) and/or advance care planning (51%). SPCT+ patients had more ‘Do not attempt cardio-pulmonary resuscitation’ orders completed prior to (12.6% versus 3.7%) and during admission (50% versus 22.1%, p < 0.001), with more SPCT+ patients deemed suitable for treatment escalation (50% versus 22.1%, p < 0.001). SPCT involvement was associated with higher discharge rates from hospital for end-of-life care (9.7% versus 0%, p < 0.001). End-of-life anticipatory prescribing was higher in SPCT+ patients, with opioids (96.3% versus 47.1%) and benzodiazepines (82.9% versus 41.2%) being used frequently for symptom control. Conclusion: SPCT referral facilitated symptom control, emergency care and discharge planning, as well as high rates of referral for psychological support than previously reported. Our study highlighted the critical need of SPCTs for patients with cancer during the pandemic and should inform service planning for this population. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Wellcome Trust Strategic Fund [PS3416] awarded to DJP and by direct project funding from the NIHR Imperial Biomedical Research Centre (BRC) awarded to DJP. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. OnCovid was supported in part by funds from the Cancer Treatment and Research Trust (CTRT) awarded to DJP and from the Associazione Italiana per la Ricerca sul Cancro Foundation [14230] awarded to AG.

  • Open Access English
    Authors: 
    Steve Simpson-Yap; Edward De Brouwer; Tomas Kalincik; Nick Rijke; J. Hillert; Clare Walton; Gilles Edan; Yves Moreau; Tim Spelman; Lotte Geys; +37 more
    Publisher: Wolters Kluwer Health
    Countries: Belgium, United Kingdom

    Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Esclerosi múltiple Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Esclerosis múltiple Coronavirus SARS-CoV-2; COVID-19; 2019-nCoV; Multiple Sclerosis Background and Objectives People with multiple sclerosis (MS) are a vulnerable group for severe coronavirus disease 2019 (COVID-19), particularly those taking immunosuppressive disease-modifying therapies (DMTs). We examined the characteristics of COVID-19 severity in an international sample of people with MS. Methods Data from 12 data sources in 28 countries were aggregated (sources could include patients from 1–12 countries). Demographic (age, sex), clinical (MS phenotype, disability), and DMT (untreated, alemtuzumab, cladribine, dimethyl fumarate, glatiramer acetate, interferon, natalizumab, ocrelizumab, rituximab, siponimod, other DMTs) covariates were queried, along with COVID-19 severity outcomes, hospitalization, intensive care unit (ICU) admission, need for artificial ventilation, and death. Characteristics of outcomes were assessed in patients with suspected/confirmed COVID-19 using multilevel mixed-effects logistic regression adjusted for age, sex, MS phenotype, and Expanded Disability Status Scale (EDSS) score. Results Six hundred fifty-seven (28.1%) with suspected and 1,683 (61.9%) with confirmed COVID-19 were analyzed. Among suspected plus confirmed and confirmed-only COVID-19, 20.9% and 26.9% were hospitalized, 5.4% and 7.2% were admitted to ICU, 4.1% and 5.4% required artificial ventilation, and 3.2% and 3.9% died. Older age, progressive MS phenotype, and higher disability were associated with worse COVID-19 outcomes. Compared to dimethyl fumarate, ocrelizumab and rituximab were associated with hospitalization (adjusted odds ratio [aOR] 1.56, 95% confidence interval [CI] 1.01–2.41; aOR 2.43, 95% CI 1.48–4.02) and ICU admission (aOR 2.30, 95% CI 0.98–5.39; aOR 3.93, 95% CI 1.56–9.89), although only rituximab was associated with higher risk of artificial ventilation (aOR 4.00, 95% CI 1.54–10.39). Compared to pooled other DMTs, ocrelizumab and rituximab were associated with hospitalization (aOR 1.75, 95% CI 1.29–2.38; aOR 2.76, 95% CI 1.87–4.07) and ICU admission (aOR 2.55, 95% CI 1.49–4.36; aOR 4.32, 95% CI 2.27–8.23), but only rituximab was associated with artificial ventilation (aOR 6.15, 95% CI 3.09–12.27). Compared to natalizumab, ocrelizumab and rituximab were associated with hospitalization (aOR 1.86, 95% CI 1.13–3.07; aOR 2.88, 95% CI 1.68–4.92) and ICU admission (aOR 2.13, 95% CI 0.85–5.35; aOR 3.23, 95% CI 1.17–8.91), but only rituximab was associated with ventilation (aOR 5.52, 95% CI 1.71–17.84). Associations persisted on restriction to confirmed COVID-19 cases. No associations were observed between DMTs and death. Stratification by age, MS phenotype, and EDSS score found no indications that DMT associations with COVID-19 severity reflected differential DMT allocation by underlying COVID-19 severity. Discussion Using the largest cohort of people with MS and COVID-19 available, we demonstrated consistent associations of rituximab with increased risk of hospitalization, ICU admission, and need for artificial ventilation and of ocrelizumab with hospitalization and ICU admission. Despite the cross-sectional design of the study, the internal and external consistency of these results with prior studies suggests that rituximab/ocrelizumab use may be a risk factor for more severe COVID-19. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article. The operational costs linked to this study are funded by the Multiple Sclerosis International Federation (MSIF) and the Multiple Sclerosis Data Alliance (MSDA), acting under the umbrella of the European Charcot Foundation. The MSDA receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Canopy Growth Corp, Genzyme, Icometrix, Merck, Mylan, Novartis, QMENTA, Quanterix, and Roche. MSIF receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Genzyme, Med-Day, Merck, Mylan, Novartis, and Roche. This work was supported by the Flemish government under the Onderzoeksprogramma Artificiële Intelligentie Vlaanderen programme and the Research Foundation Fladers (FWO) for ELIXIR Belgium–Flanders (FWO) for ELIXIR Belgium. The central platform was provided by QMENTA, and the computational resources used in this work were provided by Amazon. The statistical analysis was carried out at CORe, The University of Melbourne, with support from the National Health and Medical Research Council (NHMRC; 1129189 and 1140766).

  • Open Access English
    Authors: 
    Azambuja, Evandro de; Trapani, Dario; Loibl, Sibylle; Delaloge, Suzette; Senkus, Elzbieta; Criscitiello, Carmen; Poortman, Philip; Gnant, Michael; Di Cosimo, Serena; Cortés, Javier; +4 more
    Publisher: BMJ
    Countries: Belgium, Belgium, Spain

    The global preparedness and response to the rapid escalation to severe acute respiratory syndrome coronavirus (SARS-CoV)-2-related disease (COVID-19) to a pandemic proportion has demanded the formulation of a reliable, useful and evidence-based mechanism for health services prioritisation, to achieve the highest quality standards of care to all patients. The prioritisation of high value cancer interventions must be embedded in the agenda for the pandemic response, ensuring that no inconsistency or discrepancy emerge in the health planning processes. The aim of this work is to organise health interventions for breast cancer management and research in a tiered framework (high, medium, low value), formulating a scheme of prioritisation per clinical cogency and intrinsic value or magnitude of benefit. The public health tools and schemes for priority setting in oncology have been used as models, aspiring to capture clinical urgency, value in healthcare, community goals and fairness, while respecting the principles of benevolence, non-maleficence, autonomy and justice. We discuss the priority health interventions across the cancer continuum, giving a perspective on the role and meaning to maintain some services (undeferrable) while temporarily abrogate some others (deferrable). Considerations for implementation and the essential link to pre-existing health services, especially primary healthcare, are addressed, outlining a framework for the development of effective and functional services, such as telemedicine. The discussion covers the theme of health systems strategising, and why oncology care, in particular breast cancer care, should be maintained in parallel to pandemic control measures, providing a pragmatic clinical model within the broader context of public healthcare schemes. info:eu-repo/semantics/published SCOPUS: re.j

  • Open Access English
    Authors: 
    Askarian, Mehrdad; Semenov, Aleksandr; Llopis, Ferran; Rubulotta, Francesca; Dragovac, Gorana; Pshenichnaya, Natalia; Assadian, Ojan; Ruch, Yvon; Shayan, Zahra; Padilla Fortunatti, Cristobal; +26 more
    Countries: Belgium, Switzerland

    The aim of this study was to investigate the COVID-19 vaccination acceptance rate and its determinants among healthcare workers in a multicenter study. This was a cross-sectional multi-center survey conducted from February 5 to April 29, 2021. The questionnaire consisted of 26 items in 6 subscales. The English version of the questionnaire was translated into seven languages and distributed through Google Forms using snowball sampling; a colleague in each country was responsible for the forward and backward translation, and also the distribution of the questionnaire. A forward stepwise logistic regression was utilized to explore the variables and questionnaire factors tied to the intention to COVID-19 vaccination. 4630 participants from 91 countries completed the questionnaire. According to the United Nations Development Program 2020, 43.6 % of participants were from low Human Development Index (HDI) regions, 48.3 % high and very high, and 8.1 % from medium. The overall vaccination hesitancy rate was 37 %. Three out of six factors of the questionnaire were significantly related to intention to the vaccination. While ���Perceived benefits of the COVID-19 vaccination��� (OR: 3.82, p-value<0.001) and ���Prosocial norms��� (OR: 5.18, p-value<0.001) were associated with vaccination acceptance, ���The vaccine safety/cost concerns��� with OR: 3.52, p-value<0.001 was tied to vaccination hesitancy. Medical doctors and pharmacists were more willing to take the vaccine in comparison to others. Importantly, HDI with OR: 12.28, 95 % CI: 6.10-24.72 was a strong positive determinant of COVID-19 vaccination acceptance. This study highlighted the vaccination hesitancy rate of 37 % in our sample among HCWs. Increasing awareness regarding vaccination benefits, confronting the misinformation, and strengthening the prosocial norms would be the primary domains for maximizing the vaccination coverage. The study also showed that the HDI is strongly associated with the vaccination acceptance/hesitancy, in a way that those living in low HDI contexts are more hesitant to receive the vaccine. EXCLI Journal; 21:Doc93; ISSN 1611-2156

  • Open Access
    Authors: 
    Isabel Baenas; Mikel Etxandi; Lucero Munguía; Roser Granero; Gemma Mestre-Bach; Isabel Sánchez; Emilio Ortega; Alba Andreu; Violeta L. Moize; Jose-Manuel Fernández-Real; +55 more
    Publisher: MDPI AG
    Countries: Lithuania, Belgium, Portugal, Italy, France, Belgium, Spain, Italy
    Project: EC | PRIME (847879), EC | Eat2beNICE (728018)

    Background. The COVID-19 lockdown has had a significant impact on mental health. Patients with eating disorders (ED) have been particularly vulnerable. Aims. (1) To explore changes in eating-related symptoms and general psychopathology during lockdown in patients with an ED from various European and Asian countries; and (2) to assess differences related to diagnostic ED subtypes, age, and geography. Methods. The sample comprised 829 participants, diagnosed with an ED according to DSM-5 criteria from specialized ED units in Europe and Asia. Participants were assessed using the COVID-19 Isolation Scale (CIES). Results. Patients with binge eating disorder (BED) experienced the highest impact on weight and ED symptoms in comparison with other ED subtypes during lockdown, whereas individuals with other specified feeding and eating disorders (OFSED) had greater deterioration in general psychological functioning than subjects with other ED subtypes. Finally, Asian and younger individuals appeared to be more resilient. Conclusions. The psychopathological changes in ED patients during the COVID-19 lockdown varied by cultural context and individual variation in age and ED diagnosis. Clinical services may need to target preventive measures and adapt therapeutic approaches for the most vulnerable patients. We thank CERCA Programme/Generalitat de Catalunya for institutional support. This manuscript and research was supported by grants from the Department of Health of the Generalitat de Catalunya by the call Pla estratègic de recerca i innovació en salut (PERIS, SLT006/17/00077), the Ministerio de Economía y Competitividad (PSI201568701R), Fondo de Investigación Sanitario (FIS) (INT19/00046, PI17/01167, PI20/132), CIBERINFEC (CB21/13/00009) and co-funded by FEDER funds /European Regional Development Fund (ERDF), a way to build Europe (Eat2beNICE/ H2020-SFS-2016-2; Ref 728018; and PRIME/ H2020-SC1-BHC-2018-2020; Ref: 847879). CIBEROBN, CIBERSAM, CIBERINFEC and CIBERDEM are all initiatives of Instituto de Salud Carlos III (ISCIII). GMB is supported by a postdoctoral grant from FUNCIVA. PPM was supported, in part, by a Portuguese Foundation for Science and Technology grant (POCI-01-0145-FEDER-028145). IB was partially supported by a Post-Residency Grant from the Research Committee of the University Hospital of Bellvitge (HUB; Barcelona, Spain) 2020–2021. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. Fondo Investigacion Sanitario-FIS, Grant/Award Numbers: FIS, INT19/00046, PI17/01167; Ministerio de Economia y Competitividad, Grant/Award Number: PSI2015-68701-R; Portuguese Foundation for Science and Technology grant, Grant/Award Number: POCI-01-0145-FEDER-028145; Consejo Nacional de Ciencia y Tecnologia; Generalitat de Catalunya; European Regional Development Fund. Data Availability Statement: Individuals may inquire with Fernández-Aranda regarding availability of the data as there is ongoing studies using the data. To avoid overlapping research efforts, Fernández-Aranda will consider a request on a case-by-case basis.

  • Open Access English
    Authors: 
    Paul Hofman; M. Ilié; E. Chamorey; P. Brest; R. Schiappa; V. Nakache; M. Antoine; M. Barberis; H. Begueret; F. Bibeau; +70 more
    Publisher: Elsevier BV
    Countries: France, Italy, Slovenia, Italy, Italy, Belgium, France, Netherlands, France, Germany ...

    Background This study evaluated the consequences in Europe of the COVID-19 outbreak on pathology laboratories orientated toward the diagnosis of thoracic diseases. Materials and methods A survey was sent to 71 pathology laboratories from 21 European countries. The questionnaire requested information concerning the organization of biosafety, the clinical and molecular pathology, the biobanking, the workload, the associated research into COVID-19, and the organization of education and training during the COVID-19 crisis, from 15 March to 31 May 2020, compared with the same period in 2019. Results Questionnaires were returned from 53/71 (75%) laboratories from 18 European countries. The biosafety procedures were heterogeneous. The workload in clinical and molecular pathology decreased dramatically by 31% (range, 3%-55%) and 26% (range, 7%-62%), respectively. According to the professional category, between 28% and 41% of the staff members were not present in the laboratories but did teleworking. A total of 70% of the laboratories developed virtual meetings for the training of residents and junior pathologists. During the period of study, none of the staff members with confirmed COVID-19 became infected as a result of handling samples. Conclusions The COVID-19 pandemic has had a strong impact on most of the European pathology laboratories included in this study. Urgent implementation of several changes to the organization of most of these laboratories, notably to better harmonize biosafety procedures, was noted at the onset of the pandemic and maintained in the event of a new wave of infection occurring in Europe. Highlights • Biosafety measures used in the first wave of the COVID-19 crisis were heterogeneous in 53 European pathology laboratories. • A dramatic decrease of the workload in pathology laboratories was noted. • No case of healthcare workers contaminated with SARS-CoV-2 associated with samples handling was identified.

  • Open Access
    Authors: 
    Steve Simpson-Yap; Ashkan Pirmani; Tomas Kalincik; Edward De Brouwer; Lotte Geys; Tina Parciak; Anne Helme; Nick Rijke; Jan A. Hillert; Yves Moreau; +35 more
    Country: Belgium

    COVID-19; Severe acute respiratory syndrome; Data set COVID-19; Síndrome respiratorio agudo severo; Conjunto de datos COVID-19; Síndrome respiratòria aguda severa; Conjunt de dades Background and Objectives Certain demographic and clinical characteristics, including the use of some disease-modifying therapies (DMTs), are associated with severe acute respiratory syndrome coronavirus 2 infection severity in people with multiple sclerosis (MS). Comprehensive exploration of these relationships in large international samples is needed. Methods Clinician-reported demographic/clinical data from 27 countries were aggregated into a data set of 5,648 patients with suspected/confirmed coronavirus disease 2019 (COVID-19). COVID-19 severity outcomes (hospitalization, admission to intensive care unit [ICU], requiring artificial ventilation, and death) were assessed using multilevel mixed-effects ordered probit and logistic regression, adjusted for age, sex, disability, and MS phenotype. DMTs were individually compared with glatiramer acetate, and anti-CD20 DMTs with pooled other DMTs and with natalizumab. Results Of 5,648 patients, 922 (16.6%) with suspected and 4,646 (83.4%) with confirmed COVID-19 were included. Male sex, older age, progressive MS, and higher disability were associated with more severe COVID-19. Compared with glatiramer acetate, ocrelizumab and rituximab were associated with higher probabilities of hospitalization (4% [95% CI 1–7] and 7% [95% CI 4–11]), ICU/artificial ventilation (2% [95% CI 0–4] and 4% [95% CI 2–6]), and death (1% [95% CI 0–2] and 2% [95% CI 1–4]) (predicted marginal effects). Untreated patients had 5% (95% CI 2–8), 3% (95% CI 1–5), and 1% (95% CI 0–3) higher probabilities of the 3 respective levels of COVID-19 severity than glatiramer acetate. Compared with pooled other DMTs and with natalizumab, the associations of ocrelizumab and rituximab with COVID-19 severity were also more pronounced. All associations persisted/enhanced on restriction to confirmed COVID-19. Discussion Analyzing the largest international real-world data set of people with MS with suspected/confirmed COVID-19 confirms that the use of anti-CD20 medication (both ocrelizumab and rituximab), as well as male sex, older age, progressive MS, and higher disability are associated with more severe course of COVID-19. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: the operational costs linked to this study are funded by the Multiple Sclerosis International Federation (MSIF) and the Multiple Sclerosis Data Alliance (MSDA), acting under the umbrella of the European Charcot Foundation (ECF). The MSDA receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Canopy Growth Corporation, Genzyme, Icometrix, Merck, Mylan, Novartis, QMENTA, Quanterix, and Roche. MSIF receives income from a range of corporate sponsors, recently including Biogen, Bristol-Myers Squibb (formerly Celgene), Genzyme, Med-Day, Merck, Mylan, Novartis, and Roche. This work was supported by the Flemish Government under the Onderzoeksprogramma Artificiële Intelligentie (AI) Vlaanderen programme and the Research Foundation Fladers (FWO) for ELIXIR Belgium—Flanders (FWO) for ELIXIR Belgium. The central platform was provided by QMENTA, and the computational resources used in this work were provided by Amazon. The statistical analysis was carried out at CORe, The University of Melbourne, with support from NHMRC (1129189 and 1140766).

  • Publication . Article . Other literature type . Preprint . 2022
    Open Access English
    Authors: 
    Emma B. Hodcroft; Robert Dyrdak; Cristina Andrés; Adrian Egli; Josiane Reist; Diego García-Martínez de Artola; Julia Alcoba Florez; Hubert G. M. Niesters; Andrés Antón; Randy Poelman; +4 more
    Publisher: Public Library of Science
    Countries: Netherlands, Switzerland, Belgium, Switzerland

    BackgroundWorldwide outbreaks of enterovirus D68 (EV-D68) in 2014 and 2016 have caused serious respiratory and neurological disease.MethodsWe collected samples from several European countries during the 2018 out-break and determined 53 near full-length genome (‘whole genome’) sequences. These sequences were combined with 718 whole genome and 1,987 VP1-gene publicly available sequences.FindingsIn 2018, circulating strains clustered into multiple subgroups in the B3 and A2 subclades, with different phylogenetic origins. Clusters in subclade B3 emerged from strains circulating primarily in the US and Europe in 2016, though some had deeper roots linking to Asian strains, while clusters in A2 traced back to strains detected in East Asia in 2015-2016. In 2018, all sequences from the USA formed a distinct subgroup, containing only three non-US samples. Alongside the varied origins of seasonal strains, we found that diversification of these variants begins up to 18 months prior to the first diagnostic detection during a EV-D68 season. EV-D68 displays strong signs of continuous antigenic evolution and all 2018 A2 strains had novel patterns in the putative neutralizing epitopes in the BC- and DE-loops. The pattern in the BC-loop of the USA B3 subgroup had not been detected on that continent before. Patients with EV-D68 in subclade A2 were significantly older than patients with a B3 subclade virus. In contrast to other subclades, the age distribution of A2 is distinctly bimodal and was found primarily among children and in the elderly.InterpretationWe hypothesize that EV-D68’s rapid evolution of surface proteins, extensive diversity, and high rate of geographic mixing could be explained by substantial reinfection of adults.FundingUniversity of Basel and Swedish Foundation for Research and Development in Medical Microbiology

  • Open Access English
    Authors: 
    Gaël Dos Santos; Hao Wang; Pooja Jindal; Maria Rybo; Hélène Roul; Sridevi Pallem; Tamara Eckermann; Lode Godderis; Xavier Martínez Gómez; Eric Godard; +4 more
    Publisher: Springer Healthcare
    Country: Belgium

    Infectious disease; Influenza; Vaccine safety Enfermedad infecciosa; Gripe; Seguridad de las vacunas Malaltia infecciosa; Grip; Seguretat de les vacunes Introduction Seasonal influenza poses a major public health burden worldwide. Influenza vaccines, updated yearly to match circulating strains based on World Health Organization (WHO) recommendations, are the cornerstone of prevention and require regular monitoring. The COVID-19 pandemic is expected to cause logistical, site access and medical staff constraints and could affect the safety profile of influenza vaccines. Methods Following European Medicines Agency guidance, an enhanced safety surveillance (ESS) study assessed the frequency and severity of predefined and other adverse events (AEs) occurring within 7 days of receiving GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4), in Belgium, Germany and Spain in 2020/21, using adverse drug reaction (ADR) cards. Results During the 2020/21 influenza season, 1054 participants vaccinated with GSK’s IIV4 were enrolled (all adults in Belgium and Germany, 30% adults/70% children in Spain); 96 eligible children received a second dose. Overall, 1042 participants completed the study. After doses 1 and 2, 98.9% and 100% of participants, respectively, returned their completed ADR card. After doses 1 and 2, 37.8% (398/1054) and 13.5% (13/96) of participants, respectively, reported at least one AE. The most frequently reported categories of AEs were “general disorders and administration site conditions” (e.g. injection site pain) and “nervous system disorders” (e.g. headache). There were no deaths or serious AEs deemed related to GSK’s IIV4. Conclusion This ESS study assessed AEs in near real time. The COVID-19 pandemic did not alter the safety profile of GSK’s IIV4. No safety signals were detected during the study, which confirms the excellent safety profile of GSK’s IIV4. GlaxoSmithKline Biologicals SA funded this study (study number 207750) and was involved in all stages of the study, including analysis of the data. GlaxoSmithKline Biologicals SA also took charge of all costs associated with the development and publication of this present manuscript, including the Journal’s Rapid Service Fee.

  • Open Access
    Authors: 
    Concetta Elisa Onesti; Hope S. Rugo; Daniele Generali; Marc Peeters; Khalil Zaman; Hans Wildiers; Nadia Harbeck; Miguel Martin; Massimo Cristofanilli; Javier Cortes; +15 more
    Countries: Belgium, Italy, Belgium, Belgium, Belgium, Netherlands, Belgium, Belgium, Italy, United States ...

    Background COVID-19 appeared in late 2019, causing a pandemic spread. This led to a reorganisation of oncology care in order to reduce the risk of spreading infection between patients and healthcare staff. Here we analysed measures taken in major oncological units in Europe and the USA. Methods A 46-item survey was sent by email to representatives of 30 oncological centres in 12 of the most affected countries. The survey inquired about preventive measures established to reduce virus spread, patient education and processes employed for risk reduction in each oncological unit. Results Investigators from 21 centres in 10 countries answered the survey between 10 April and 6 May 2020. A triage for patients with cancer before hospital or clinic visits was conducted by 90.5% of centres before consultations, 95.2% before day care admissions and in 100% of the cases before overnight hospitalisation by means of phone calls, interactive online platforms, swab test and/or chest CT scan. Permission for caregivers to attend clinic visits was limited in many centres, with some exceptions (ie, for non-autonomous patients, in the case of a new diagnosis, when bad news was expected and for terminally ill patients). With a variable delay period, the use of personal protective equipment was unanimously mandatory, and in many centres, only targeted clinical and instrumental examinations were performed. Telemedicine was implemented in 76.2% of the centres. Separated pathways for COVID-19-positive and COVID-19-negative patients were organised, with separate inpatient units and day care areas. Self-isolation was required for COVID-19-positive or symptomatic staff, while return to work policies required a negative swab test in 76.2% of the centres. Conclusion Many pragmatic measures have been quickly implemented to deal with the health emergency linked to COVID-19, although the relative efficacy of each intervention should be further analysed in large observational studies. info:eu-repo/semantics/published SCOPUS: ar.j