Repositório Científico do Instituto Nacional de Saúde
Entradas recentes
Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008
Publication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernandez, Maria Jose; Gundert-Remy, Ursula; Ursula Gundert‐Remy; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barmaz, Stefania; Carfì, Maria; Civitella, Consuelo; Gagliardi, Gabriele; Lodi, Federica; Martino, Carla; Mazzoli, Elena; Mech, Agnieszka; Rasinger, Josef Daniel; Rincon, Ana Maria; Ruggeri, Laura; Smeraldi, Camilla; Tard, Alexandra; Zakidou, Panagiota
This guidance document applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food additive, submitted under Regulation (EC) No 1333/2008. It defines the scientific data required to evaluate if the food additive is safe under the proposed conditions of use, in accordance with Articles 1 and 6 of Regulation (EC) No 1333/2008. The data requirements pertain to the characterisation of the proposed food additive, including the description of its identity, manufacturing process, specifications, stability, reaction and fate in foods and methods of analysis in food; the proposed uses and use levels and the dietary exposure; the safety data, including information on the genotoxic potential of the food additive, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should provide data in accordance with this guidance document to support the safety assessment of the proposed food additive. Based on the submitted data, EFSA will assess the safety of the food additive in line with the risk assessment principles described in this document and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.
A multi-stakeholder perspective on Barriers to the adoption of personalized prevention in European healthcare systems
Publication . Costa, Alexandra; Cardoso, Maria Luís; Carvalho, Adriana Reimão; Osti, Tommaso; Farina, Sara; Taha, Abdelrahman; Savoia, Cosimo; Russo, Luigi; Maio, Alessandra; Scarsi, Nicolò; Flodkvist, Evelina; Gyllenberg, Alexandra; Boccia, Stefania; Vicente, Astrid Moura
Introduction: Personalized prevention is an important component of personalized medicine, tailoring interventions to the biological, behavioral, sociocultural and environmental characteristics of individuals for the prevention of disease onset, progression and recurrence. Despite its potential, personalized preventive interventions (PPI) remain less commonly implemented in clinical practice. This study explored the main barriers to a broader adoption of PPI in European healthcare systems.
Methods: A multi-stakeholder consultation involving citizens/patients, health professionals, researchers, and policymakers was conducted using a sequential mixed-methods approach. In the first phase, semi-structured interviews with key informants representing different stakeholder groups were conducted. The thematic analysis of interview findings, complemented by insights from a review of the literature, informed the development of an online survey implemented in the second phase of the study.
Twenty-six interviews and 270 complete surveys were analyzed. Stakeholders identified barriers across three main domains: (1) healthcare systems, (2) implementation, and (3) awareness, education, and literacy. Key barriers associated with limited PPI adoption included the predominant focus of health strategies on treatment over prevention, unresolved ethical, legal, and social issues (ELSI), limited awareness and knowledge of personalized prevention among both professionals and citizens, and the lack of appropriate cost–benefit evaluation models.
Findings highlight interconnected barriers that may impact a broader PPI adoption across healthcare system, governance, implementation, and awareness-related domains. Continued stakeholder dialogue and engagement, alongside efforts to address awareness and governance-related challenges, may support the broader integration of PPI into European healthcare systems.
Cancer Prevention Literacy Questionnaire (CPL-Q): development and validation within the World Code Against Cancer Framework
Publication . Feliu, Ariadna; Islam, Rubana; Romeo-Cervera, Paula; Bouaoun, Liacine; Whitelock, Victoria; Pirvan, Mirela; Roxo, Luis; Carvalho da Silva Santos, Ana João; Espina, Carolina
Background: Health literacy is a key determinant of health, shaping individuals ability to understand and act on health information. Low cancer literacy is associated with fatalistic beliefs and reduced participation in prevention and screening programmes. Although around 40% of all cancers are preventable, public awareness of modifiable risk factors remains low. The European Code Against Cancer (ECAC), developed under the World Code Against Cancer Framework, aims to strengthen prevention knowledge; however, tools to measure cancer prevention literacy, and therefore evaluate its impact, are lacking. This study aimed to develop and validate a questionnaire to assess ‘cancer prevention literacy’ in adults from the general population.
Methods: We conducted a methodological study to develop a questionnaire measuring ‘cancer prevention literacy’ in adults from the general population using the Integrative Model of Behavioural Prediction as theoretical framework. Questionnaire development followed a three-stage process: (1) a literature review and two-round Delphi process to select and refine items; (2) a third Delphi round, complemented by readability checks, face-validity assessment, and cognitive testing to evaluate item relevance, clarity, and representativeness; and (3) a pre-test and psychometric analysis to assess construct validity.
Results: The final Cancer Prevention Literacy Questionnaire (CPL-Q) consists of a 10-question validated instrument comprising 58 items, with selected items incorporating the verbatim wording of the recommendations from the ECAC, 4th edition. Strong expert agreement was achieved through an iterative Delphi process, and content and face validity indicated that the items were comprehensible, relevant, and appropriate. Psychometric analyses, including exploratory and confirmatory factor analysis, provide preliminary support for the instrument’s construct validity, with initial evidence suggesting acceptable reliability.
Conclusion: The CPL-Q provides a standardised instrument to measure ‘cancer prevention literacy’ and to assess the impact of Regional Codes Against Cancer through monitoring and benchmarking changes over time. It also offers a practical tool to identify gaps in ‘cancer prevention literacy’ within specific populations and to support international comparisons and longitudinal evaluations, thereby contributing to the evidence base for cancer prevention policies.
COVID-19 vaccination and antibody response in healthcare workers: a longitudinal serological study following the 2023-2024 COVID-19 vaccination campaign
Publication . Almeida Santos, João; Henriques, Camila; Amaral, Palmira; Guiomar, Raquel; Machado, Ausenda; Gaio, Vânia
Background: Healthcare workers (HCWs) are essential frontline responders to public health emergencies and are one of the risk groups targeted by annual vaccination campaigns. Serological studies are valuable for high-risk groups such as HCWs, as they contribute to assess vulnerability, monitor infection control measures, and guide vaccination strategies in high-risk settings. This study aimed to assess humoral response at baseline, 3 and 6 months after the 2023–2024 COVID-19 vaccination campaign in HCWs, and to identify demographic and clinical factors associated with variations in antibody levels over time.
Methods: Prospective cohort study of vaccinated HCWs at a central hospital in Portugal (September 2023–May 2024). Serial serological tests to assess anti-spike receptor-binding domain (anti-RBD/S) and anti-nucleocapsid protein (anti-N) IgG antibodies were used to monitor the immune response and SARS-CoV-2 infection history, respectively. Wilcoxon signed-rank tests were used to assess changes in antibody levels over time, and linear regression models were used to identify factors associated with variations in SARS-CoV-2 anti-RBD/S IgG concentrations, on the basis of available demographic and clinical data.
Results: In a cohort of 166 HCWs who received the 2023–2024 COVID-19 booster vaccine, anti-RBD/S IgG antibody levels significantly increased at 3 months post-vaccination (16 007.4 vs. 30 572.9 AU/mL) before declining by 6 months (18 327.3 AU/mL), nearing baseline levels. Previous infection (β = 1.92, 95% CI: 1.33-2.77) and older age (β = 2.65, 95%CI: 1.64‐4.29) were associated with higher antibody concentrations at baseline, whereas smoking was linked to lower antibody levels at 6 months (β = 0.32, 95%CI: 0.11–0.88). Other factors, such as sex and chronic conditions, had no consistent significant impact over time.
Conclusions: Although SARS-CoV-2 anti-RBD/S IgG antibody concentrations declined significantly six months after the 2023–2024 COVID-19 booster vaccination, they remained at relatively high concentrations over the follow-up period. This study provides new insight into these dynamics in a highly vaccinated and exposed HCWs cohort during a later post-pandemic phase, highlighting the influence of prior infection, age, and smoking on antibody persistence and reinforces the relevance of ongoing immune monitoring of this risk group to guide tailored control strategies. However, vaccine effectiveness studies in highly exposed and vaccinated populations, such as HCWs, are needed to better inform the role of antibody monitoring in this context, especially given the ongoing trend of annually updated vaccines.
Nontraditional Data in Pandemic Preparedness and Response: Identifying and Addressing First- and Last- Mile Challenges
Publication . Mazzoli, Mattia; Varela-Lasheras, Irma; Namorado, Sónia; Caetano, Constantino; Leite, Andreia; Hermans, Lisa; Hens, Niel; Türkmen, Polen; Kalimeri, Kyriaki; Ferres,Leo; Cattuto, Ciro; Paolotti, Daniela; Verhulst, Stefaan
The COVID-19 pandemic served as an important test case of complementing traditional public health data with nontraditional data, such as mobility traces, social media activity, and wearable data, to inform real-time decision-making. Drawing on an expert workshop and a targeted survey of epidemic modelers in Europe, this study assesses the promise and the persistent limitations of such data in pandemic preparedness and response. We distinguish between “first-mile” challenges (obstacles to accessing and harmonizing data) and “last-mile” challenges (difficulties in translating insights into actionable policy interventions). The expert workshop, convened in March 2024 in Brussels, brought together 50 participants, including public health professionals, data scientists, policymakers, and industry leaders, to reflect on lessons learned and define strategies for better integration of nontraditional data into epidemic modeling and policymaking. The accompanying survey, gathering experiences from 29 modelers, offers empirical evidence of the barriers faced by modelers during the COVID-19 pandemic and highlights areas where key data were unavailable or underused. The experiences collected through the survey and workshop resulted in ten key actions and three overarching recommendations for public entities, data providers, and stakeholders. Our findings reveal ongoing issues with data access, quality, and interoperability, as well as institutional and cognitive barriers to evidence-based decision-making. Approximately 66% of all datasets had at least one access problem, with data sharing reluctance for nontraditional sources being double that of traditional data (30% vs 15%). Only 10% of respondents reported that they could use all the data they needed. These limitations included issues related to timeliness and granularity of data, as well as issues with linkage, comparability, and biases. To overcome these hurdles, we propose a set of enabling mechanisms, including data inventories, standardization protocols, simulation exercises, data stewardship roles, and data collaboratives. For first-mile challenges, solutions focus on technical and legal frameworks for data access. For last-mile challenges, we recommend fusion centers, decision accelerator laboratories, and networks of scientific ambassadors to bridge the gap between analysis and action. We argue that realizing the full value of nontraditional data requires a sustained investment in institutional readiness, cross-sectoral collaboration, and a shift toward a culture of data solidarity. Grounded in the lessons of the COVID-19 pandemic, the study can be used to design a roadmap for using nontraditional data to confront a broader array of public health emergencies, from climate shocks to humanitarian crises.