Impact of sharing Alzheimer's disease biomarkers with individuals without dementia: A systematic review and meta-analysis of empirical data.

INTRODUCTION: We conducted a systematic literature review and meta-analysis of empirical evidence on expected and experienced implications of sharing Alzheimer's disease (AD) biomarker results with individuals without dementia. METHODS: PubMed, Embase, APA PsycInfo, and Web of Science Core Collection were searched according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results from included studies were synthesized, and quantitative data on psychosocial impact were meta-analyzed using a random-effects model. RESULTS: We included 35 publications. Most personal stakeholders expressed interest in biomarker assessment. Learning negative biomarker results led to relief and sometimes frustration, while positive biomarkers induced anxiety but also clarity. Meta-analysis of five studies including 2012 participants (elevated amyloid = 1324 [66%], asymptomatic = 1855 [92%]) showed short-term psychological impact was not significant (random-effect estimate = 0.10, standard error = 0.23, P = 0.65). Most professional stakeholders valued biomarker testing, although attitudes and practices varied considerably. DISCUSSION: Interest in AD biomarker testing was high and sharing their results did not cause psychological harm. HIGHLIGHTS: Most personal stakeholders expressed interest in Alzheimer's disease biomarker assessment. Personal motivations included gaining insight, improving lifestyle, or preparing for the future. There was no short-term psychological impact of sharing biomarker status, implying it can be safe. Most professional stakeholders valued biomarker testing, believing the benefits outweigh the risk. Harmonized guidelines on biomarker testing and sharing results are required.

Suggestions to Improve the Comprehensibility of Current Definitions of Scientific Authorship for International Authors.

Much has been said about the need for improving the current definitions of scientific authorship, but an aspect that is often overlooked is how to formulate and communicate these definitions to ensure that they are comprehensible and useful for researchers, notably researchers active in international research consortia. In light of a rapid increase in international collaborations within natural sciences, this article uses authorship of this branch of sciences as an example and provides suggestions to improve the comprehensibility of the definitions of authorship in natural sciences. It assesses whether the definition of authorship provided by the European Code of Conduct for Research Integrity can deal with current issues and problems of scientific authorship. Notably, problems that are experienced in project groups with researchers coming from multiple countries. Using theories developed by Jürgen Habermas and Robert Merton, a normative framework is developed to articulate ethical authorship in natural sciences. Accordingly, enriching the current definition of authorship with normative elements and using discipline-specific metaphors to communicate them are introduced as possible ways of improving the comprehensibility of the definition of authorship in international environments. Finally, this article provides a proposal to be considered in the future revisions of the European Code of Conduct for Research Integrity.

Factors associated with acceleration of clinical development for infectious diseases: a cross-sectional analysis of 10-year EMA registration data.

Background: Clinical trials feature centrally in the development of drugs and vaccines to determine safety and efficacy. Clinical development can be slow and may have a duration of more than ten years. Global public health threats such as Ebola virus disease (EVD) and COVID-19 have demonstrated that it is possible to accelerate clinical trials while maintaining safety and efficacy. We investigated acceleration in clinical trials over the past decade and identified factors associated with acceleration for drugs targeting infectious diseases. Methods: A cross-sectional study was performed of all medicinal compounds targeting infectious diseases that received marketing authorisation by the European Medicines Agency (EMA) between 2012 and 2022. We calculated median clinical development time in years between the first phase 1 trial enrolment date and the authorisation date. Multivariable linear regression analysis was performed to identify factors associated with shorter development times. Findings: Eighty-one trajectories were included. The median clinical development time was 7.3 years (IQR 4.4-12.3). The fastest times belonged to drugs and vaccines targeting COVID-19 (1.3 years, IQR 0.8-1.6), EVD (5.5 years, IQR 5.1-5.8), and Hepatitis A-E (5.5 years, IQR 3.9-8.2). Factors associated with shorter development times were outbreak setting (-5.4 years [95% CI, -8.2 to -2.6]), accelerated assessment status (-4.0 years [95% CI, -7.6 to -0.5]), and drugs with combined compounds (-2.7 years [95% CI, -4.9 to -0.4]). Interpretation: Clinical development time for infectious disease-related drugs and vaccines was relatively short, and outbreak setting and accelerated EMA assessment were associated with shorter development times. Funding: Amsterdam Public Health research institute.

Should we promote influenza vaccination of health care workers in nursing homes? Some ethical arguments in favour of immunization.

Although studies show the relation between influenza immunization of health care workers and the benefits for residents in nursing homes, compliance to vaccination is still low. In this article we explore and discuss two specific moral reasons for nursing home professionals to accept vaccination. These special reasons derive from two sources: the responsibilities they have as health professionals, and the responsibilities they have as a member of the collective.