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- Giubilato, E, et al.
(författare)
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Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products
- 2020
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Ingår i: Materials (Basel, Switzerland). - : MDPI AG. - 1996-1944. ; 13:20
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Tidskriftsartikel (refereegranskat)abstract
- The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.
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- Johansson, Lena, 1972, et al.
(författare)
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Associations between Depression, Depressive Symptoms, and Incidence of Dementia in Latin America: A 10/66 Dementia Research Group Study
- 2019
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Ingår i: Journal of Alzheimers Disease. - : IOS Press. - 1387-2877 .- 1875-8908. ; 69:2, s. 433-441
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Tidskriftsartikel (refereegranskat)abstract
- Background: A growing body of evidence suggests that depression is related to dementia in older adults. Previous research has been done in high-income countries and there is a lack of studies in low- and middle income countries (LMICs). Objective: To examine the relationship between depressive symptoms and incidence of dementia in a population-based study of older adults in Latin America. Methods: The study is a part of the 10/66 Dementia Research Group's population survey and includes 11,472 older adults (baseline mean age 74 years) from Cuba, Dominican Republic, Mexico, Peru, Puerto Rico, and Venezuela. The baseline examinations were done in 2003-2007 and the follow-up examinations 4 years later. Semi-structured psychiatric interviews gave information about ICD-10 depression and sub-syndromal depression (i.e., >= 4 depressive symptoms) at baseline. Information on dementia were collected at the follow-up examination. Competing risk models analyzed the associations between depression and incidence of dementia and the final model were adjusted for age, sex, education, stroke, and diabetes. Separate analyses were conducted for each site and then meta-analyzed by means of fixed effect models. Results: At baseline, the prevalence of depression was 26.0% (n= 2,980): 5.4% had ICD-10 depression and 20.6% subsyndromal depression. During the follow-up period, 9.3% (n = 862) developed dementia and 14.3% (n = 1,329) deceased. In the pooled analyses, both ICD-10 depression (adjusted sub-hazard ratio (sHR) 1.63, 95% confidence interval (CI) 1.26-2.11) and sub-syndromal depression (adjusted sHR 1.28, 95% CI: 1.09-1.51) were associated with increased incidence of dementia. The Higging I-2 tests showed a moderate heterogeneity across the study sites. Conclusion: Our findings suggest that late-life depression is associated with the incidence of dementia in LMICs in Latin America, which support results from earlier studies conducted in high-income countries.
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- Minelli, Caterina, et al.
(författare)
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Versailles project on advanced materials and standards (VAMAS) interlaboratory study on measuring the number concentration of colloidal gold nanoparticles
- 2022
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Ingår i: Nanoscale. - : Royal Society of Chemistry (RSC). - 2040-3372 .- 2040-3364. ; 14, s. 4690-4704
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Tidskriftsartikel (refereegranskat)abstract
- We describe the outcome of a large international interlaboratory study of the measurement of particle number concentration of colloidal nanoparticles, project 10 of the technical working area 34, "Nanoparticle Populations" of the Versailles Project on Advanced Materials and Standards (VAMAS). A total of 50 laboratories delivered results for the number concentration of 30 nm gold colloidal nanoparticles measured using particle tracking analysis (PTA), single particle inductively coupled plasma mass spectrometry (spICP-MS), ultraviolet-visible (UV-Vis) light spectroscopy, centrifugal liquid sedimentation (CLS) and small angle X-ray scattering (SAXS). The study provides quantitative data to evaluate the repeatability of these methods and their reproducibility in the measurement of number concentration of model nanoparticle systems following a common measurement protocol. We find that the population-averaging methods of SAXS, CLS and UV-Vis have high measurement repeatability and reproducibility, with between-labs variability of 2.6%, 11% and 1.4% respectively. However, results may be significantly biased for reasons including inaccurate material properties whose values are used to compute the number concentration. Particle-counting method results are less reproducibile than population-averaging methods, with measured between-labs variability of 68% and 46% for PTA and spICP-MS respectively. This study provides the stakeholder community with important comparative data to underpin measurement reproducibility and method validation for number concentration of nanoparticles.
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- Falk, Hanna, 1977, et al.
(författare)
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Self-rated health and its association with mortality in older adults in China, India and Latin America - a 10/66 Dementia Research Group study
- 2017
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Ingår i: Age and Ageing. - : Oxford University Press (OUP). - 0002-0729 .- 1468-2834. ; 46:6, s. 932-939
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Tidskriftsartikel (refereegranskat)abstract
- Background empirical evidence from high-income countries suggests that self-rated health (SRH) is useful as a brief and simple outcome measure in public health research. However, in many low- and middle-income countries (LMIC) there is a lack of evaluation and the cross-cultural validity of SRH remains largely untested. This study aims to explore the prevalence of SRH and its association with mortality in older adults in LMIC in order to cross-culturally validate the construct of SRH. Methods population-based cohort studies including 16,940 persons aged ≥65 years in China, India, Cuba, Dominican Republic, Peru, Venezuela, Mexico and Puerto Rico in 2003. SRH was assessed by asking ‘how do you rate your overall health in the past 30 days’ with responses ranging from excellent to poor. Covariates included socio-demographic characteristics, use of health services and health factors. Mortality was ascertained through a screening of all respondents until 2007. Results the prevalence of good SRH was higher in urban compared to rural sites, except in China. Men reported higher SRH than women, and depression had the largest negative impact on SRH in all sites. Without adjustment, those with poor SRH showed a 142% increase risk of dying within 4 years compared to those with moderate SRH. After adjusting for all covariates, those with poor SRH still showed a 43% increased risk. Conclusion our findings support the use of SRH as a simple measure in survey settings to identify vulnerable groups and evaluate health interventions in resource-scares settings.
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