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- 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.
- Surveillance of severe acute respiratory infections associated with SARS-CoV-2, influenza virus and RSV using ICD-10 codes: a case definition accuracy study across five European countries, 2021 to 2023Publication . Sanchez Ruiz, Miguel Angel; Marques, Diogo Fp.; Lomholt, Frederikke Kristensen; Vestergaard, Lasse Skafte; Monge, Susana; Lozano Álvarez, Marcos; Aspelund, Gudrun; Thordardottir, Marianna; Dziugyte, Ausra; Cauchi, John-Paul; Boere, Tjarda M.; Veldhuijzen, Irene K.; Seppälä, Elina; Bøås, Håkon; Paulsen, Trine Hessevik; Machado, Ausenda; Rodrigues, Ana Paula; Hooiveld, Mariette; Alves de Sousa, Luis; Torres, Ana; Carvalho, Carlos; Nunes, BaltazarBackgrounds: Surveillance of severe acute respiratory infections (SARI) using ICD-10 codes from electronic health records (EHR) lacks consensus on optimal case-defining codes.AIMWe determined codes that maximise sensitivity (Se) and positive predictive value (PPV) for SARI associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza virus and respiratory syncytial virus (RSV) in Denmark, Iceland, Malta, Norway and Spain.METHODSWe included hospitalisations from week 21/2021 to 39/2023, with ICD-10 diagnostic codes for respiratory disease (three-character codes J00-J99) or COVID-19 (U07.1, U07.2, country-specific codes for Denmark). We assessed Se and PPV of individual codes against laboratory results. Based on Se and PPV rank-sum, we selected the top 10 codes and combined them into 10 sets per pathogen. We identified sets that maximised the clinical utility index (CUI = Se × PPV), categorised as excellent (≥ 0.81), good (0.64-0.80), satisfactory (0.49-0.63) and poor (< 0.49).RESULTSWe assessed 395,163 hospitalisations for SARI-SARS-CoV-2, 313,418 for SARI-influenza and 192,936 for SARI-RSV, all tested. For SARI-SARS-CoV-2, code U07.1 (B34.2A, B97.2A for Denmark) had excellent utility in Denmark, Malta, Norway, Spain (≥ 0.82), and good utility in Iceland (0.79). For SARI-influenza, J09, J10 and J11 performed excellently in Denmark, Norway, Spain (≥ 0.83), satisfactorily in Malta (0.52), and poorly in Iceland (0.43). For SARI-RSV, J12, J20 and J21 achieved highest CUI but had poor utility (0.17-0.34).CONCLUSIONSCOVID-19- and influenza-specific three-character ICD-10 codes accurately identified SARI associated with SARS-CoV-2 and influenza virus. For SARI-RSV, four-character codes should be explored. We recommend context-specific assessments in countries adopting EHR-based surveillance.
- Effectiveness of JN.1 monovalent COVID-19 vaccination in EU/EEA countries between October 2024 and January 2025: a VEBIS electronic health record network studyPublication . Humphreys, James; Blake, Alexandre; Nicolay, Nathalie; Braeye, Toon; Van Evercooren, Izaak; Hansen, Christian Holm; Moustsen-Helms, Ida Rask; Sacco, Chiara; Mateo-Urdiales, Alberto; Castilla, Jesús; Martínez-Baz, Iván; Machado, Ausenda; Brito, André; Ljung, Rickard; Pihlstrom, Nicklas; Mansiaux, Yohann; Monge, Susana; Bacci, Sabrina; Nunes, Baltazar; VEBIS-Lot 4 working groupWe estimated vaccine effectiveness (VE) of Omicron JN.1-adapted COVID-19 vaccines administered during the 2024 autumnal vaccination campaign against COVID-19 hospitalisation and death among eligible individuals aged ≥65 years. The study period was October 2024-January 2025. Using a common protocol across six EU/EEA study sites, we linked electronic health records to construct retrospective cohorts and applied Cox modelling to estimate VE via confounder-adjusted hazard ratios. The majority of vaccines administered during the study period were Omicron JN.1-adapted COVID-19 vaccines (99 %). VE against hospitalisation was 60 % (95 % Confidence Interval: 48-70 %) and against COVID-19-related death was 78 % (95 %CI: 64-87 %) among individuals aged 65-79 years; 58 % (95 %CI: 48-66 %) and 62 % (95 %CI: 32-79 %) among those aged ≥80 years. These results indicate high effectiveness in the initial months of the campaign. Continued monitoring is necessary to confirm these results, including estimates of VE in those with longer time since vaccination and during different variant predominance periods.
- Long term bivalent mRNA vaccine effectiveness against COVID-19 hospitalisations and deaths in Portugal: a cohort study based on electronic health recordsPublication . Machado, Ausenda; Kislaya, Irina; Soares, Patricia; Magalhães, Sarah; Nunes, Baltazar; On behalf of PT-EHR vaccine groupBackground: In Autumn 2022, there were recommendations for a COVID-19 booster vaccination with adapted bivalent vaccines to eligible population. Evaluating vaccine effectiveness (VE), in a short period after the vaccination, is key to guide public health decisions on the vaccine performance, allowing implementation of mitigation strategies promptly. However, to assess long-term protection post-vaccination and evaluate the need for additional boosters, it is crucial to conduct studies that span the maximum duration of the vaccination program. This study aims to estimate the VE of bivalent mRNA vaccines against COVID-19-related hospitalisation and death in the Portuguese population aged 65 years or older, from September 2022 to May 2023. Methods: We used a cohort approach to analyse six electronic health registries using deterministic linkage, with a follow-up period of eight months. Severe outcomes included COVID-19-related hospitalisations and death, classified using discharge ICD-10 codes as proxies. The exposure of interest was the bivalent mRNA vaccine. VE was estimated for 14-97, 98-181 and 182-240 days after bivalent vaccination. Confounder-adjusted hazard ratio (aHR) was obtained by fitting a time-dependent Cox regression model with time-dependent vaccination status, adjusted for sociodemographic, history of influenza and pneumococcus vaccination, previous SARS-CoV-2 tests and infection, and comorbidities. VE was estimated by one minus the aHR between vaccinated with bivalent vaccine person-years versus those without bivalent vaccine person-years. Results: The cohort included 2,151,531 individuals aged 65 or older (27.8% with 80 or more years). In the ≥ 80 years old, VE was 41.3% (95%CI: 34.5-47.5%) and 50.3% (95%CI: 44.6-55.3%) against COVID-19-related hospitalisation and death, respectively. In the 65-79 years old, VE was 58.5% (95%CI: 51.9-64.2%) against COVID-19-related hospitalisation, and 65.1% (95%CI: 59.0-70.4%) against COVID-19-related death. VE waned for both age groups and outcomes. Among adults aged 65 years or older, we observed long-term moderate VE estimates against severe COVID-19-related outcomes. Conclusions: These results support the need for yearly boosters of COVID-19 vaccination to maximise the protection of the senior population against COVID-19 severe disease. Additional (spring boosters) during a vaccination campaign should be evaluated considering the epidemiological context and results from long-term VE studies.
- Perceptions of Fall Prevention and Engagement in Social Prescribing Activities Among Older Adults: A Cross-Sectional Study in PortugalPublication . Matos, Cristiano; Baixinho, Cristina Rosa; Alarcão, Violeta; Henriques, Maria Adriana; Ferreira, Ricardo Oliveira; Nascimento, Tiago; Arriaga, Miguel; JORGE SILVA ALVES, TATIANA DANIELA; Nogueira, Paulo; Costa, AndreiaBackground: Falls are a major cause of injury, functional decline, and reduced quality of life among older adults, posing a significant public health challenge. Social prescribing is gaining relevance in gerontology, offering structured strategies to engage individuals in preventive activities, including fall prevention strategies, through engagement in community-based activities. Aim: To examine older adults' perception of the relevance of personal protection and development activities (e.g., prevention against falling) and compare sociodemographic, behavioural, and engagement profiles between those who agree and those who disagree with its relevance. Methods: A cross-sectional study was conducted with 613 older adults aged 65-93 years. Data collection included sociodemographic, health-related, and behavioural/social engagement variables (including perceptions regarding the benefits of social prescribing and interest in community-based activities). For this analysis, participants were dichotomized based on their agreement with the relevance of personal protection and development activities (e.g., prevention against falling). Of the 569 participants included, 538 (94.5%) agreed with its relevance and 31 (5.5%) disagreed. Descriptive and exploratory analyses were conducted to compare the two groups across variables. Multivariate logistic regression analyses were conducted to explore independent predictors of agreement across sociodemographic, behavioural, social prescribing, and health-related variables. Results: Significant differences were observed between the groups in awareness of active ageing (p = 0.018), volunteering (p < 0.001), participation in social and community activities (p < 0.001), and hobbies like gardening, fishing, or cooking (p = 0.002). Those who agreed with the importance of personal protection and development activities were significantly more likely to value a range of initiatives, including social activities in recreational organizations, physical activity in the community (e.g., hiking), artistic and creative activities (e.g., visual arts, music), technical or technological activities (e.g., do-it-yourself, computers), and cultural enrichment activities (e.g., visiting museums), (p < 0.001). Multivariate analyses showed no effects of sociodemographic or health-related factors, whereas behavioural and engagement-related variables-including volunteering, hobbies, and several social prescribing activities-significantly predicted agreement with the relevance of personal protection and development activities. Discussion: The findings suggest that older adults who perceive fall prevention as relevant are more actively engaged in diverse health-promoting activities, including volunteering, hobbies, and community-based programmes. This pattern may reflect higher health literacy, stronger social networks, and proactive attitudes towards ageing. Conclusions: Perceptions of fall prevention are closely linked to broader patterns of engagement in health-promoting activities among older adults. Recognizing and addressing differences in how these activities are valued can inform more inclusive and targeted gerontological interventions.