Recent progress in synthetic biology (SynBio) has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials (FIH) will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including 'risk' minimization. These concerns are associated with any FIH trial, however, due to the novelty of the approach, they become more pronounced for medical applications of emerging technologies (emTech) like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using 'risk assessment' as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as 'risk' and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue.
Background: Health literacy (HL) refers to the capacity to access, understand, appraise and apply information for decision-making and acting in health-related matters. In the field of Alzheimer’s disease (AD), expanding technologies of early disease detection, disease course prediction and eventually personalized prevention confront individuals at-risk with increasingly complex information, which demand substantial HL skills. Here we report current findings of HL research in at-risk groups. Methods: Search strings, referring to HL, AD, amyloid and risk, were developed. A systematic review was conducted in PUBMED, Cochrane Library, PsycINFO, and Web of Science to summarize the state of evidence on HL in at-risk individuals for Alzheimer’s dementia. Eligible articles needed to employ a validated tool for HL, mention the concept or one dimension (access, understand, appraise and apply information for decision-making and acting). Results: 26 quantitative and 9 qualitative studies addressing at least one dimension of HL were included. Overall, there is evidence for a wish to gain knowledge about the own brain status and risk of dementia. Psychological distress may occur and the subjective benefit-risk estimation may be modified after risk disclosure. Effects on lifestyle and planning may occur. Overall understanding and appraisal of information related to AD risk seem variable with several impacting factors. In mild cognitive impairment (MCI) basic HL skill seem to be affected by cognitive dysfunction. Conclusions: Systematic assessment of HL in at-risk population for AD is sparse. Findings indicate the paramount importance of adequate communication with persons at risk, being sensitive to individual needs and preferences. Substantial research needs were identified.
Objective
Numerous studies suggest that health literacy (HL) plays a crucial role in maintaining and improving individual health. Empirical findings highlight the relation between levels of a person's HL and her/his clinical outcome. To date, the role of HL in persons at‐risk for psychosis has not been systematically reviewed.
Methods
We conducted a systematic review using a mixed‐methods approach to analyse a variety of study types. Peer‐reviewed publications were systematically searched in PUBMED, Cochrane Library, PsycINFO and Web of Science.
Results
The search string returned 10587 publications. After screening, 15 quantitative, four qualitative studies and two reviews were included. Only one study assessed HL as primary outcome, assessing knowledge and beliefs about psychosis among the general population. In the other studies, sub‐dimensions of HL were investigated. None of the publications operationalized HL or it's sub‐dimensions with a validated measure.
Conclusions
A lack of understanding of their condition, and fear of stigmatization, were associated with a delay in help‐seeking among people with clinical‐high‐risk state for psychosis. Family members, school personnel, general practitioners and the internet play a crucial role in the HL process. Considerable barriers in obtaining adequate specialist support emphasize the urgent need of a “HL environment” for persons at risk for psychosis.
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