Computer-Assisted Visual Training in Children and Adolescents with Developmental Visual Disorders.

BACKGROUND: In this systematic review, we address the question whether children and adolescents with developmental visual disorders benefit from computer-assisted visual training. METHODS: Systematic literature searches were carried out in three bibliographic databases (initial search in October 2021) and trial registries. Included were randomized controlled trials that evaluated the efficacy of computer-assisted visual training in children and adolescents with developmental visual disorders in comparison to no training, sham training, or conservative treatment. RESULTS: The inclusion criteria were met by 17 trials (with a total of 1323 children and adolescents) focusing on binocular or monocular computer-assisted visual training for the treatment of amblyopia. In these trials, visual training was carried out for 2 to 24 weeks, either as "stand alone" therapy or in addition to occlusion therapy. Six trials showed a statistically significant difference in favor of the visual training for the outcome "best corrected visual acuity of the amblyopic eye." However, this difference was small and mostly below the threshold of clinical relevance of -0.05 logMAR (equivalent to an improvement of 0.5 lines on the eye chart, or 2.5 letters per line). Only few data were available for the outcomes "binocular vision" and "adverse events"; the differences between the groups were similarly small. CONCLUSION: The currently available data do not permit any firm conclusions regarding the efficacy of visual training in children and adolescents with amblyopia. Moreover, treatment adherence was often insufficient and the treatment durations in the trials was relatively short. No results from randomized trials have yet been published with respect to other developmental visual disorders (refractive errors, strabismus).

Long-Term Impact of Disasters on the Public Health System: A Multi-Case Analysis.

As past events have shown, disasters can have a tremendous impact on the affected population's health. However, research regarding the long-term impact on a systems level perspective is still scarce. In this multi-case study, we analyzed and compared the long-term impacts on the public health system of five disasters which took place in Europe: avalanche (Austria), terror attack (Spain), airplane crash (Luxembourg), cable-car tunnel fire (Austria), and a flood in Central Europe. We used a mixed-methods approach consisting of a document analysis and interviews with key stakeholders, to examine the various long-term impacts each of the disasters had on health-system performance, as well as on security and health protection. The results show manifold changes undertaken in the fields of psychosocial support, infrastructure, and contingency and preparedness planning. The holistic approach of this study shows the importance of analyzing long-term impacts from the perspective of the type (e.g., disasters associated with natural hazards) and characteristic (e.g., duration and extent) of a disaster, as well as the regional context where a disaster took place. However, the identified recurring themes demonstrate the opportunity of learning from case studies in order to customize the lessons and apply them to the own-disaster-management setting.

Health Technology Assessment (HTA) and Access Policies.

For patients, innovations in healthcare can be both a great blessing (when saving people's life or improving quality of life), as well as a curse (when only few people have access, e.g., because of high prices). Thus, when healthcare innovations are proven safe and ready for application, decision makers have to apply access policies and sometimes face difficult assessments. In this context, health technology assessment (HTA) plays a crucial role at European Union level, forming an evidence-based, transparent basis for decision making through joint assessments. However, pricing and reimbursement aspects are exempt from collaborative assessments, since these are in the responsibility of the EU Member States: according to Art. 168(7) TFEU the 'organisation and delivery of health services and medical care [… including] the allocation of the resources assigned to them' remain an exclusive competence of Member States. However, future challenges may require further cooperation.

Research Ethics Committees in the field of health-related human research--a European perspective and the case of Austria.

Human subject abuse and patient harm through medical research have led to the establishment of Institutional Review Boards (IRBs or Research Ethics Committees (RECS)), who independently scrutinise research protocols. In the field of trials with medicinal products as well as trials testing medical devices, an obligation for submission prior to realisation is granted within Europe through European directives. However, regulation of other fields of health-related research, e.g., psychological trials, public health and epidemiological studies or healthcare research is the responsibility of EU Member States; and European laws differ widely. The article gives an overview of European regulations in the field of REC review requirements, critically analyses Austrian legislation in this field and describes an institutional solution for legislative gaps in Austria--the Research Committee for Scientific and Ethical Questions (RCSEQ). Finally, important European initiatives for the future are pointed out.

Biomedical research and human research subject protection: is there need for action in Germany and Austria?

Biomedical research and international collaborations in biomedical research become more and more important--economically and politically, making harmonised legislation for human research subject protection indispensible. The European Convention on Human Rights and Biomedicine is the first binding contract under international law to protect human rights in the field of biomedical research. Almost 10 years after its entry into force neither Germany nor Austria have signed or ratified the Convention. Research involving incapacitated adults is one of the key issues in this context. This paper analyses the Convention and other European, US and international legislation, focusing on research involving incapacitated adults in "nontherapeutic" trials. It shows that a ban of "non-therapeutic" research involving incapacitated adults leads to an unjust exclusion of this patient group, leading to uncertainty and disadvantages in medical treatment.