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- Cross-sectional study on protective antibodies against influenza A virus subtypes and cross-protection against influenza A(H3N2) subclade K, Portugal, August 2025Publication . Guiomar, Raquel; Henriques, Camila; Pereira da Silva, Susana; Gomes, Licínia; Dias, Daniela; Verdasca, Nuno; Portuguese Laboratory Network for the Diagnosis of Influenza and Respiratory Viruses; Nunes, Baltazar; Rodrigues, Ana PaulaThe 2025/26 season was marked by co-circulation of influenza A subtypes, with the first detection of A(H3N2) subclade K in September 2025. In August 2025 in Portugal, 14.8% (95% CI: 12.2-17.8) of 886 persons tested had cross-protective antibodies against this subclade. The overall seroprevalence against circulating A(H1N1)pdm09 strains was 28.1% (95% CI: 24.4-32.0). These data highlight the presence of previous cross-reactive antibodies and the possible advantage of vaccination in the extent of detectable antibodies against influenza viruses.
- Evaluation of European severe acute respiratory infection (SARI) surveillance, 27 European countries, 2022/23Publication . Marques, Diogo Fp; Kovacs, Dory; Sanchez-Ruiz, Miguel-Angel; Rodrigues, Ana Paula; Machado, Ausenda; Mazagatos, Clara; Monge, Susana; Domegan, Lisa; O'Donnell, Joan; Hooiveld, Mariette; Emborg, Hanne-Dorthe; Nunes, Baltazar; Carvalho, Carlos; Rose, Angela McBackground: Between 2020 and 2023, ECDC has supported 21 of 30 EU/EEA and six Western Balkan countries by enhancing severe acute respiratory infection (SARI) surveillance to monitor trends, detect unexpected events, evaluate public health interventions, identify risk factors and support vaccine effectiveness studies. Using diverse strategies, countries have implemented SARI surveillance and reported data at national/European levels.AimWe evaluated European-level SARI surveillance and provided recommendations to achieve objectives and improve key attribute performance.MethodsWe analysed 2022/23 surveillance data for completeness. We administered a questionnaire, targeting country-level representatives, to evaluate surveillance attributes (meeting objectives, usefulness, acceptability, timeliness, representativeness) and identify strengths, weaknesses, opportunities and threats.ResultsThirteen countries (13/27) reported data at European level. Data showed good overall completeness but varied across countries and some variables need improvement (vaccination, sequencing). The questionnaire was completed by all 27 countries. Most countries (23/27) reported that the system effectively monitored trends and considered it useful and acceptable (25/27), but only 16 found it timely and 14 representative. Challenges included insufficient case-based data, data linkage issues and insufficient data completeness. Slow/inefficient manual data extraction affected timeliness, while insufficient geographical coverage affected representativeness. Multi-pathogen surveillance was identified as the main strength, heterogeneity of systems the main weakness, improvements of hospital information systems the main opportunity, and lack of sustainable funding the main threat.ConclusionsSARI surveillance was perceived as effective in monitoring trends, useful and acceptable. To achieve additional objectives and enhance timeliness and representativeness, we recommend improving data completeness, digitalisation/automation and geographical coverage.
- Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA): Part V – Benefits for stakeholders other than participantsPublication . Buchta, Christoph; De la Salle, Barbara; Marrington, Rachel; Aburto Almonacid, Andrés; Albarède, Stéphanie; Badrick, Tony; Bullock, David; Cobbaert, Christa M.; Coucke, Wim; Delatour, Vincent; Faria, Ana Paula; Geilenkeuser, Wolf-Jochen; Griesmacher, Andrea; Huggett, Jim F.; Ianovska, Viktoriia; Kammel, Martin; Kessler, Anja; Körmöczi, Günther F.; Meijer, Piet; Miranda, Armandina; Patel, Dina; Pezzati, Paola; Sandberg, Sverre; Schennach, Harald; Schweiger, Christian R.; Schwenoha, Karin; Spannagl, Michael; Sung, Heungsup; Thelen, Marc; Weykamp, Cas; Zeichhardt, Heinz; Restelli, Veronica; Perrone, Lucy A.External quality assessment (EQA) enhances patient safety through the evaluation of the quality of laboratory-based and point of care testing. Regulatory agencies and accreditation organizations utilize the results and the laboratory's response to them as part of assessing the laboratory's fitness to practice. In addition, where EQA samples are commutable and the assigned value has been determined using reference measurement procedures (RMPs), EQA data contributes to the verification of metrological traceability of assays as part of the post-market surveillance of diagnostic (IVD) medical devices (IVD-MDs). More broadly, the scientific and medical communities use EQA data to demonstrate that medical laboratory examination procedures are fit for clinical purposes, to evaluate common reference intervals, and inclusion of data in clinical databases. Scientific groups, the IVD industry, reference laboratories and National Metrology Institutes can work with EQA providers to identify measurands, which should urgently be supported by the development of reference materials or methods. The ability of health systems to respond effectively to fast-evolving medical challenges, such as the Coronavirus Disease-19 (COVID-19) pandemic, is reliant on EQA to demonstrate confidence in the performance of new laboratory methods and testing services. EQA providers are uniquely positioned to assess the performance of IVD-MDs in addition to individual laboratories and testing sites. Although the primary focus of EQA providers remains the improvement of the performance of individual laboratories, there are many stakeholders who benefit from EQA performance data.
- Support Needs of Parents of Children With Congenital Anomalies Across Europe: A EUROlinkCAT SurveyPublication . Marcus, Elena; Latos-Bielenska, Anna; Jamry-Dziurla, Anna; Barišić, Ingeborg; Cavero-Carbonell, Clara; Den Hond, Elly; Garne, Ester; Genard, Lucas; Santos, Ana João; Lutke, L Renée; Dias, Carlos Matias; Páramo-Rodríguez, Lucía; Pedersen, Christina Neergaard; Neville, Amanda J.; Niemann, Annika; Odak, Ljubica; Pierini, Anna; Rissmann, Anke; Rankin, Judith; Morris, Joan K.Background: Parents and carers of children with congenital anomalies can experience stress when managing their child's healthcare needs. It is important that they are well supported. This study explored the support needs of parents/carers of children with a congenital anomaly across Europe. Methods: We developed a cross-sectional online survey to measure parents' experiences of support at diagnosis and in subsequent years. We recruited parents/carers of children (0-10 years) with cleft lip, congenital heart defect requiring surgery, Down syndrome and/or spina bifida, online via relevant organisations in 10 European countries (March-July 2021). Results: A total of 1109 parents/carers were recruited in Poland (n = 476), the United Kingdom (n = 120), Germany (n = 97), Belgium/Netherlands (n = 74), Croatia (n = 68), Italy (n = 59), other European countries (n = 92) and unspecified/non-European countries (n = 84). At diagnosis, only 27% (262/984) of parents/carers reported feeling well supported by HCPs, and 49% (468/959) reported that they would have liked professional psychological support but did not receive it. After diagnosis, satisfaction with support from HCPs differed significantly across countries, whereas satisfaction with support from participants' personal networks was more consistent. Conclusion: Our findings suggest that parents require greater support from HCPs at diagnosis, particularly psychological support. Further research in a European context is needed to understand what the barriers to support might be and how it may be integrated more effectively into existing healthcare systems.
- The potential bias introduced into COVID-19 vaccine effectiveness studies at primary care level due to the availability of SARS-CoV-2 tests in the general populationPublication . Lanièce Delaunay, Charlotte; Nunes, Baltazar; Monge, Susana; de Lange, Marit; Túri, Gergő; Machado, Ausenda; Latorre-Margalef, Neus; Mlinarić, Ivan; Lazar, Mihaela; Botella Rocamora, Paloma; Erdwiens, Annika; Sève, Noémie; Domegan, Lisa; Martínez-Baz, Iván; Hooiveld, Mariëtte; Oroszi, Beatrix; Guiomar, Raquel; Sperk, Maike; Kurečić Filipović, Sanja; Pascu, Catalina; Linares Dopido, Juan Antonio; Dürrwald, Ralf; Rameix-Welti, Marie-Anne; McKenna, Adele; Castilla, Jesús; van Hagen, Cheyenne; Knol, Mirjam; Bacci, Sabrina; Kaczmarek, Marlena; Kissling, Esther; VEBIS Primary Care Vaccine Effectiveness GroupBackground: With SARS-CoV-2 self-tests, persons with acute respiratory infections (ARI) can know their COVID-19 status. This may alter their decision to consult a general practitioner (GP), potentially biasing COVID-19 vaccine effectiveness (VE) studies. We explore bias mechanisms, simulate magnitude, and verify control methods. Methods: We used directed acyclic graphs (DAGs) to illustrate the bias mechanisms. Based on the European primary care VEBIS multicentre test-negative design (TND) study, we simulated populations with varying true VE (20%-60%), proportions of persons with ARI self-testing (10%-30%), effect of COVID-19 vaccination on self-testing (1.5-2.5), and effect of self-test result on GP consultation (0.5-2). We performed 5000 runs per scenario, estimating VE among those consulting a GP. We calculated bias as true VE minus mean simulated VE, unadjusted and adjusted for self-testing, using logistic regression. Results: DAGs suggested collider stratification bias if vaccination had an effect on self-testing and if self-test results affected GP consultation. Bias was -12% to 18% at 20% true VE, with the most extreme associations and 30% self-testing. With 60% true VE and 10%-20% self-testing, bias was lower. Bias was higher (-18% to 45%) if both positive and negative self-test results affected GP consultation. Adjusting for self-testing removed the bias. Conclusions: Self-testing may bias COVID-19 VE TND studies in primary care if self-testing is high, particularly with low VE. We recommend primary care TND VE studies collect self-testing information to eliminate potential bias. Observational studies are needed to understand the relationship between vaccination, self-testing, and GP consultation, in these studies' source population.
- Relative effectiveness of the second booster COVID-19 vaccines against laboratory confirmed SARS-CoV-2 infection in healthcare workers: VEBIS HCW VE cohort study (1 October 2022-2 May 2023)Publication . Savulescu, Camelia; Prats-Uribe, Albert; Brolin, Kim; Uusküla, Anneli; Bergin, Colm; Fleming, Catherine; Zvirbulis, Viesturs; Zavadska, Dace; Szułdrzyński, Konstanty; Gaio, Vânia; Popescu, Corneliu Petru; Craiu, Mihai; Cisneros, Maria; Latorre-Millán, Miriam; Lohur, Liis; McGrath, Jonathan; Ferguson, Lauren; Abolina, Ilze; Gravele, Dagne; Machado, Ausenda; Florescu, Simin Aysel; Lazar, Mihaela; Subirats, Pilar; Clusa Cuesta, Laura; Sui, Jacklyn; Kenny, Claire; Krievins, Dainis; Barzdina, Elza Anna; Melo, Aryse; Kosa, Alma Gabriela; Miron, Victor Daniel; Muñoz-Almagro, Carmen; Milagro, Ana María; Bacci, Sabrina; Kramarz, Piotr; Nardone, Anthony; VEBIS HCW Study GroupIntroduction: Repeated COVID-19 booster vaccination was recommended in healthcare workers (HCWs) to maintain protection. We measured the relative vaccine effectiveness (rVE) of the second booster dose of COVID-19 vaccine compared to the first booster, against laboratory-confirmed SARS-CoV-2 infection in HCWs. Methods: In a prospective cohort study among HCWs from 12 European hospitals, we collected nasopharyngeal or saliva samples at enrolment and during weekly/fortnightly follow-up between October 2022 and May 2023. We estimated rVE of the second versus first COVID-19 vaccine booster dose against SARS-CoV-2 infection, overall, by time since second booster and restricted to the bivalent vaccines only. Using Cox regression, we calculated the rVE as (1-hazard ratio)*100, adjusting for hospital, age, sex, prior SARS-CoV-2 infection and at least one underlying condition. Results: Among the 979 included HCWs eligible for a second booster vaccination, 392 (40 %) received it and 192 (20 %) presented an infection during the study period. The rVE of the second versus first booster dose was -5 % (95 %CI: -46; 25) overall, 3 % (-46; 36) in the 7-89 days after receiving the second booster dose. The rVE was 11 % (-43; 45) when restricted to the use of bivalent vaccines only. Conclusion: The bivalent COVID-19 could have reduced the risk of SARS-CoV-2 infection among HCWs by 11 %. However, we note the limitation of imprecise rVE estimates due to the proportion of monovalent vaccine used in the study, the small sample size and the study being conducted during the predominant circulation of XBB.1.5 sub-lineage. COVID-19 vaccine effectiveness studies in HCWs can provide important evidence to inform the optimal timing and the use of updated COVID-19 vaccines.
- Tracking epidemiological shifts in hepatitis A in Portugal: a comparison of seroprevalence between two nationwide surveys, 2001 to 2002 and 2015 to 2016Publication . Manageiro, Vera; Matos, Rita; Palminha, Paula; Cortes-Martins, Helena; Nunes, Baltazar; de Sousa, RitaHepatitis A incidence in Portugal declined from 20.1 to 0.4/100,000 population between 1987 and 2023, changing non-vaccinated population susceptibility. This shift has contributed to more frequent outbreaks, including in 2024-25, highlighting the need to enhance surveillance and integrate serological data. We aimed to describe the exposure profile of the Portuguese population to hepatitis A virus (HAV) over time by estimating and comparing the seroprevalence of hepatitis A in two nationwide surveys. Data from two cross-sectional seroprevalence studies performed in 2001-02 and 2015-16 in the population aged ≥ 2 years were analysed. Seroprevalence was weighted for population distribution by age, sex and region, and then analysed by birth cohort (1911 -2014) and compared using Poisson regression. Overall prevalence of anti-HAV IgG antibodies was 67.3% (95% CI: 64.2-70.3) in 2001-02 (n = 1,642) and 56.3% (95% CI: 52.4-60.2) in 2015-16 (n = 2,052), showing an 11-percentage-point decline. Birth cohort analysis revealed consistent seroprevalence within each cohort in both surveys, i.e. seroprevalence for the 1981-90 birth cohort was 16.7% and 18.7%, respectively, suggesting that higher seroprevalence is more closely associated with birth cohort (cohort effect) rather than a specific time point. Additionally, we found that individuals aged ≥ 30 years, born before the 1980s, and those with lower education had higher seroprevalence. The immunological profile of anti-HAV antibodies in the Portuguese population has shifted over the last decades. High susceptibility and shifting age distribution of Hepatitis A-seropositive individuals highlight the need to revise future vaccination strategies in Portugal.
- Whole-Genome Sequencing of Extended-Spectrum β-Lactamase-Producing Klebsiella pneumoniae Isolated from Human Bloodstream InfectionsPublication . Sabença, Carolina; Rivière, Rani; Costa, Eliana; Sousa, Sara; Caniça, Manuela; Silva, Vanessa; Igrejas, Gilberto; Torres, Carmen; Poeta, PatríciaKlebsiella pneumoniae is a Gram-negative bacterium commonly associated with bloodstream infections (BSIs), which can lead to severe clinical outcomes, especially in immunocompromised individuals or patients with underlying health conditions. The increasing prevalence of K. pneumoniae that produces extended-spectrum β-lactamases (ESBL) poses a significant challenge for treatment and infection control, necessitating a swift diagnostic approach and tailored antimicrobial therapy to improve patient outcomes. A total of 32 K. pneumoniae isolates were recovered from BSIs from December 2021 to August 2022. Whole-genome sequencing (WGS) was performed on the 14 ESBL-producing isolates. All ESBL isolates carried the blaCTX-M-15 gene, together with other β-lactamase-encoding genes (blaTEM-1, blaSHV-28, blaSHV-26, or blaOXA-1). Three of the isolates also carried the blaKPC-3 gene. Resistance genes to quinolones, sulfonamides, tetracycline, aminoglycosides, and chloramphenicol were also detected. We can conclude that the presence of ESBL-producing isolates among K. pneumoniae of BSIs raises concerns, since these enzymes limit the available treatment options, and future research must include studies on alternative therapies for dealing with resistant bacterial infections and developing new approaches to disease treatment.
- The 24-Hour Activity Checklist for Cerebral Palsy: Translation, Content Validity and Test-Retest Reliability of Portuguese VersionsPublication . Vila-Nova, Fabio; Sá, Cristina; Leite, Hércules Ribeiro; Cadete, Ana; Folha, Teresa; Longo, Egmar; Martins, Maria Elisabete; Oliveira, RaulBackground: The importance of 24-h movement behaviour, including sleep, physical activity (PA) and sedentary behaviour (SB), has gained prominence due to its significant impact on the health and development of children, including those with cerebral palsy (CP). The 24-h activity checklist for CP, a tool developed in the Netherlands to monitor the activity in CP paediatric population, requires translation and cultural adaptation to Portuguese for use in Brazil and Portugal. Methods: This cross-sectional methodological study involved translating and culturally adapting the 24-h activity checklist for CP into Brazilian Portuguese (BP) and European Portuguese (EP) languages. The process included forward translation, synthesis and backward translation, expert panel evaluation and pretesting. Brazilian and Portuguese experts appraised content validity, assessed by the individual item (I-CVI) and scale level content validity index scores (S-CVI/Ave). Sixty parents of children with CP participated in the test-retest analysis, reported with the Intraclass Correlation Coefficients (ICCs). Results: I-CVI scores were higher than 0.78 for both versions. S-CVI/Ave scores were considered excellent for BP (0.91) and EP version (1.0). Expert's appraisal results in the inclusion of a question about sleep-related time indicators and the split of sleep, PA, and screen time questions for weekdays and weekends. Brazilian and Portuguese parents of children with CP reported understanding on instructions, questions, and answer options. The ICC values range from 0.81 to 0.99 and 0.6 to 0.98, for BP and EP, respectively. Conclusions: The BP and EP versions of 24-h activity checklist for CP demonstrated good content validity and test-retest reliability, supporting its use in Brazil and Portugal. This tool can contribute to improving communication between families and healthcare professionals to monitor and develop tailored interventions for healthy movement behaviours in children with CP.
- Recommendations for estimating and reporting vaccine effectiveness by time since vaccination: a COVID-19 case studyPublication . Kissling, Esther; Nunes, Baltazar; Hooiveld, Mariëtte; Martínez-Baz, Iván; Monge, Susana; Robertson, Chris; Knolm, Mirjam; Sève, Noémie; Mlinarić, Ivan; Domegan, Lisa; Machado, Ausenda; Whitaker, Heather; Lazar, Mihaela; Meijer, Adam; Enkirch, Theresa; Casado, Itziar; Pérez-Gimeno, Gloria; William, Naoma; Enouf, Vincent; Kurečić Filipović, Sanja; McKenna, Adele; Rodrigues, Ana Paula; de Lusignan, Simon; Timnea, Olivia-Carmen; Latorre-Margalef, Neus; Castilla, Jesús; Pozo, Francisco; Hamilton, Mark; Masse, Shirley; Ilić, Maja; Basile, Luca; O’Donnell, Joan; Guiomar, Raquel; Riess, Maximilian; Popescu, Rodica-Manuela; M C Rose, Angela; Andrews, Nick; Bacci, Sabrina; Pastore Celentano, Lucia; Valenciano, Marta; Moren, Alain; Beutels, Philippe; Hens, Niel; I-MOVE-COVID-19 and ECDC primary care study teamsEstimating COVID-19 vaccine effectiveness (VE) by time since vaccination (TSV) is essential for understanding how protection may change over time and enables meaningful comparisons across studies. This is important for accurate comparisons of VE against different SARS-CoV-2 variants/sublineages, across age groups, during different periods post vaccination campaign, or by vaccine type/brand. We provide recommendations for case–control VE studies on estimating and reporting VE analyses by TSV, with the aim of improving quality of these estimates. Our recommendations cover study design and pre-analysis considerations, descriptive analyses, choice of categories of TSV, categorical and continuous modelling approaches, and best practices for reporting VE by TSV. Using a real-life case–control study, we apply these recommendations, and include accompanying statistical scripts in R and Stata. These recommendations will serve as a practical resource for researchers conducting VE analyses by TSV. We encourage ongoing refinement of them through input from other study groups.