Background This paper discusses a paradox in mental health. It manifests as a relationship between adverse “bad” effects (suffering, clinical costs, loss of productivity) in individuals and populations and advantageous “good” aspects of mental disorders. These beneficial aspects (scientific, artistic and political accomplishments) emanate at the societal level through the frequently unprecedented creativity of people suffering from mental disorders and their relatives. Such gains can contribute to societal innovation and problem-solving. Especially in times of accelerated social-ecological change, approaches are needed that facilitate best-possible mental health care but also recognize creative ideas conducive to beneficial clinical and social-ecological innovations as soon as possible. Discussion This paper emphasizes the need to account for creativity as a crucial component in evolving mental health systems and societies. It highlights the need for wide-ranging approaches and discusses how research targeting multiple facets (e.g., brain level, cognitive neuroscience, psychiatry, neurology, socio-cultural, economic and other factors) might further our understanding of the creativity-mental disorder link and its importance for innovating mental health systems and societies. Conclusion Our discussion clarifies that considerable research will be needed to obtain a better understanding of how creativity associated with mental disorders may help to create more sustainable societies on a fast-changing planet through innovative ideas. Given the current-state-of-the-art of research and healthcare management, our discussion is currently speculative. However, it provides a basis for how pros and cons might be studied in the future through transdisciplinary research and collaborations across sectors of society.
Health system resilience testing has generated keen interest since the COVID-19 pandemic but so far no methodology for this complex exercise exists. Our concept of resilience testing is inspired by the experience of stress tests in the banking sector. The novel approach is a mixed-method country-led exercise, which applies a health system lens to a particular shock scenario, and identifies vulnerabilities using the Health System Performance Assessment Framework for Universal Health and the Shock Cycle. In the first part of the presentation we describe the resilience testing methodology, based on the two conceptual frameworks. We share lessons from the required preparatory work: shock scenario selection, scope of background research, formation of a resilience testing group, resilience test day structure and process, and the facilitator's role. We also discuss the outcomes of the resilience testing process, which includes a formal assessment of the resilience of the health system. This will provide workshop participants with an overview of key concepts to conduct a country-led resilience testing exercise. The second part of the presentation focuses on the overarching results from the country-led pilots. These show that the resilience testing method can identify specific health system weaknesses at different stages of the shock cycle. Given the appropriate selection of resilience test facilitator and participants, the method can also detect system-wide challenges, shock implications and spill-overs. The participant interaction on the test day may identify key priorities for action and strengthen relevant national multiprofessional networks. Overall, the resilience testing approach is an important new tool to identify strengths and weaknesses of the current health system and in scenario-specific preparedness planning.
During this presentation, discussion will be held around several of the decisions made for the sample climate change scenario, suggested indicators and their implications. This provides the audience with an example process of how to put together a shock scenario and prepare a resilience test given the tools and methodology the resilience testing project provides. There is increasing evidence of climate change and its associated health risks. Whilst resilience is required against a multitude of threats, resilience to climate change induced health risks will be essential for health systems in the future. This scenario focuses on a heat wave that is complicated by a follow-on shock, the collapse of the electrical grid. Deliberate choices were made to include two shocks, the integration of heat warning systems, suggestions to increase the demand for health services and how to include considerations of vulnerable groups. These will be discussed in the context of how to customise a scenario to a country context including the current functioning, replacing the shock mechanism of heat wave with other shocks such as flood or fires, and including the lessons of previous experience of environmental shocks. Resilience testing tools, such as the resilience testing manual, other sample scenarios and peer-to-peer scenario repository website will be demonstrated in practical application. This shock initially has an impact on the service delivery and resource generation functions of the health system performance assessment (HSPA) framework but the impacts flow into the other functions. The workshop will go through the combined framework, indicators that are useful to assess health systems resilience and questions that are proposed to the guide the discussion of the resilience testing exercise. From the discussion participants will be better prepared to implement resilience testing in their countries, understanding how to customise the shock of a heat wave to their local context.
The importance of improving brain and mental health and developing sustainable environments is increasingly recognised. Understanding the syndemic interactions between these processes can help address contemporary societal challenges and foster global innovation. Here, we propose a green brain capital model that integrates environmental drivers of brain health and green skills necessary for long-term sustainability and discuss the role of interdisciplinary approaches in promoting individual and collective behavioural changes. We draw on existing literature and research to highlight the connections between brain health, environmental factors and green skills. Environmental factors and exposome can have long-lasting adverse effects on brain health, particularly in vulnerable populations. Investing in green brain capital can prepare societies to address global crises. Green skills, including creativity, ecological intelligence and digital literacy, are critical for promoting sustainable environments. Access to nature improves brain and mental health, and interdisciplinary fields such as neurourbanism can inform urban planning to benefit citizens’ well-being. Building brain capital and environmental sustainability interactions requires increasing future generations’ awareness, education and training. A comprehensive approach to green brain capital can enable greater societal scaling, synergistically protecting brain health and environmental sustainability.
In May 2022, there is an International Regulatory and Pharmaceutical Industry (Innovation and Quality [IQ] Microphysiological Systems [MPS] Affiliate) Workshop on the standardization of complex in vitro models (CIVMs) in drug development. This manuscript summarizes the discussions and conclusions of this joint workshop organized and executed by the IQ MPS Affiliate and the United States Food and Drug Administration (FDA). A key objective of the workshop is to facilitate discussions around opportunities and/or needs for standardization of MPS and chart potential pathways to increase model utilization in the context of regulatory decision making. Participation in the workshop included 200 attendees from the FDA, IQ MPS Affiliate, and 26 global regulatory organizations and affiliated parties representing Europe, Japan, and Canada. It is agreed that understanding global perspectives regarding the readiness of CIVM/MPS models for regulatory decision making and potential pathways to gaining acceptance is useful to align on globally. The obstacles are currently too great to develop standards for every context of use (COU). Instead, it is suggested that a more tractable approach may be to think of broadly applicable standards that can be applied regardless of COU and/or organ system. Considerations and next steps for this effort are described.
The economic disruptions experienced during the COVID-19 pandemic and Russia’s invasion of Ukraine have generated a narrative of resilience and deglobalization that brings the old world order into question. Heightened public attention on perceived supply chain failures has exerted pressure on governments to intervene in firm-level operations to assure supply of essential or strategic goods. This paper argues that the narrative is founded on false premises. In particular, three supply chain myths have emerged in public and academic discourse: (i) lean management has gone too far and exacerbated disruptions in global supply chains; (ii) efficient supply chains are less resilient; and (iii) foreign supply makes supply chains less resilient. We argue that these beliefs are not adequately supported by evidence. They can displace analysis to negatively impact policy and actually diminish resilience. Drawing upon IB and supply chain management research, we investigate the root causes of perceived market failures. Recommendations are for an evidence-based debate on current events and policies.
Background The International Survey of People living with Chronic Conditions (OECD-PaRIS survey), aims to systematically gather patient-reported experiences (PREMs) and - outcomes (PROMs) and potential predictors for these outcomes for persons with chronic conditions as well as information from professionals about health care provided. In such patient surveys, the advantages of a multilevel (nested) approach in which patients are sampled ‘within providers’ need to be balanced against the potential for bias if patient populations from participating GPs significantly differ from those of non-participating GPs. The objective was to assess the effects of general practitioner (GP) non-participation on the representativeness of the Norwegian patient data of the International Survey of People living with Chronic Conditions (OECD-PaRIS survey). Methods For the Norwegian part of the field trial in 2022, we randomly sampled and surveyed 75 GPs and 125 patients 45 years and older for each GP, regardless of whether their GP were also participating in the study. We compared GP and patient characteristics as well as patient-reported experiences and outcomes according to GP participation status in bivariate analysis, supplemented with multiple linear regressions with PREMs/PROMs as dependent variables and participation status as independent adjusting for significant patient factors. Results 17 of 75 sampled GPs participated (22.7%), of which 993 of 2,015 patients responded (49.3%). 3,347 of 7,080 patients of non-responding GPs answered (47.3%). Persons with chronic conditions from participating GPs reported significantly better patient-centred coordinated care (p = 0.017), overall experiences with the GP office the last 12 months (p = 0.004), mental well-being (p = 0.039) and mental health (p = 0.013) than patients from non-participating GPs. The raw differences between participating and non-participating GPs on the primary outcomes varied from 1.5 to 2.9 points on a 0-100 scale, and from 2.2 to 3.0 after adjustment for case-mix. Conclusions The Norwegian field trial indicates that estimates based on participants in the PaRIS survey may modestly overestimate patient-reported experiences and -outcomes at the aggregated level and the need for more research within and across countries to identify and address this potential bias.
Antimicrobial, and particularly antibiotic resistance are one of the world's biggest challenges today, and urgent action is needed to reinvigorate the antibiotic development pipeline. To inform policy discussions during and after the 2023 Swedish Presidency of the Council of the European Union, we critically appraise incentive options recently proposed by the European Commission, and member states, and consider what has been achieved over the last two decades in relation to antibiotic research and development. While several new antibiotics have achieved regulatory approval in recent years, almost none have innovative characteristics such as new chemical classes or novel mechanisms of action. We consider four incentive options to incentivise research and development of new antibiotics, including subscription payments, market entry rewards, transferable exclusivity extensions, and milestone payments. While each option has advantages and drawbacks, a combination of incentives may be required and continued investment is needed by the EU in push incentives, such as direct funding and grants, to incentivise drug discovery and preclinical stages of development. The EU must also coordinate with international initiatives and support access to new and pre-existing antibiotics in LMICs through platforms such as the WHO, and G7 and G20 group of countries.
Metabolic comorbidities are common in patients with cardiorenal disease; they can cause atherosclerotic cardiovascular disease (ASCVD), speed progression, and adversely affect prognosis. Common comorbidities are Type 2 diabetes mellitus (T2DM), obesity/overweight, chronic kidney disease (CKD), and chronic liver disease. The cardiovascular system, kidneys, and liver are linked to many of the same risk factors (e.g. dyslipidaemia, hypertension, tobacco use, diabetes, and central/truncal obesity), and shared metabolic and functional abnormalities lead to damage throughout these organs via overlapping pathophysiological pathways. The COVID-19 pandemic has further complicated the management of cardiometabolic diseases. Obesity, T2DM, CKD, and liver disease are associated with increased risk of poor outcomes of COVID-19 infection, and conversely, COVID-19 can lead to worsening of pre-existing ASCVD. The high rates of these comorbidities highlight the need to improve recognition and treatment of ASCVD in patients with obesity, insulin resistance or T2DM, chronic liver diseases, and CKD and equally, to improve recognition and treatment of these diseases in patients with ASCVD. Strategies to prevent and manage cardiometabolic diseases include lifestyle modification, pharmacotherapy, and surgery. There is a need for more programmes at the societal level to encourage a healthy diet and physical activity. Many pharmacotherapies offer mechanism-based approaches that can target multiple pathophysiological pathways across diseases. These include sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide-1 receptor agonists, selective mineralocorticoid receptor antagonists, and combined glucose-dependent insulinotropic peptide/glucagon-like peptide-1 receptor agonist. Non-surgical and surgical weight loss strategies can improve cardiometabolic disorders in individuals living with obesity. New biomarkers under investigation may help in the early identification of individuals at risk and reveal new treatment targets.
The predominantly animal-centric approach of chemical safety assessment has increasingly come under pressure. Society is questioning overall performance, sustainability, continued relevance for human health risk assessment and ethics of this system, demanding a change of paradigm. At the same time, the scientific toolbox used for risk assessment is continuously enriched by the development of "New Approach Methodologies" (NAMs). While this term does not define the age or the state of readiness of the innovation, it covers a wide range of methods, including quantitative structure-activity relationship (QSAR) predictions, high-throughput screening (HTS) bioassays, omics applications, cell cultures, organoids, microphysiological systems (MPS), machine learning models and artificial intelligence (AI). In addition to promising faster and more efficient toxicity testing, NAMs have the potential to fundamentally transform today's regulatory work by allowing more human-relevant decision-making in terms of both hazard and exposure assessment. Yet, several obstacles hamper a broader application of NAMs in current regulatory risk assessment. Constraints in addressing repeated-dose toxicity, with particular reference to the chronic toxicity, and hesitance from relevant stakeholders, are major challenges for the implementation of NAMs in a broader context. Moreover, issues regarding predictivity, reproducibility and quantification need to be addressed and regulatory and legislative frameworks need to be adapted to NAMs. The conceptual perspective presented here has its focus on hazard assessment and is grounded on the main findings and conclusions from a symposium and workshop held in Berlin in November 2021. It intends to provide further insights into how NAMs can be gradually integrated into chemical risk assessment aimed at protection of human health, until eventually the current paradigm is replaced by an animal-free "Next Generation Risk Assessment" (NGRA).
Network effects, economies of scale, and lock-in-effects increasingly lead to a concentration of digital resources and capabilities, hindering the free and equitable development of digital entrepreneurship, new skills, and jobs, especially in small communities and their small and medium-sized enterprises (“SMEs”). To ensure the affordability and accessibility of technologies, promote digital entrepreneurship and community well-being, and protect digital rights, we propose data cooperatives as a vehicle for secure, trusted, and sovereign data exchange. In post-pandemic times, community/SME-led cooperatives can play a vital role by ensuring that supply chains to support digital commons are uninterrupted, resilient, and decentralized. Digital commons and data sovereignty provide communities with affordable and easy access to information and the ability to collectively negotiate data-related decisions. Moreover, cooperative commons (a) provide access to the infrastructure that underpins the modern economy, (b) preserve property rights, and (c) ensure that privatization and monopolization do not further erode self-determination, especially in a world increasingly mediated by AI. Thus, governance plays a significant role in accelerating communities’/SMEs’ digital transformation and addressing their challenges. Cooperatives thrive on digital governance and standards such as open trusted application programming interfaces (“APIs”) that increase the efficiency, technological capabilities, and capacities of participants and, most importantly, integrate, enable, and accelerate the digital transformation of SMEs in the overall process. This review article analyses an array of transformative use cases that underline the potential of cooperative data governance. These case studies exemplify how data and platform cooperatives, through their innovative value creation mechanisms, can elevate digital commons and value chains to a new dimension of collaboration, thereby addressing pressing societal issues. Guided by our research aim, we propose a policy framework that supports the practical implementation of digital federation platforms and data cooperatives. This policy blueprint intends to facilitate sustainable development in both the Global South and North, fostering equitable and inclusive data governance strategies.
The potential for future prevention of Alzheimer’s disease and related dementias (ADRD) through healthy lifestyle change is spurring a positive brain health movement. However, most ADRD research continues to focus on mid- and later life. We lack evidence regarding risk exposure and protective factors in young adulthood, i.e., 18–39 years. Brain capital is an emerging framework that represents the combination of education, knowledge, skills, and optimal brain health that people accumulate over their lives. Building on this framework, we present a new model that focuses on optimizing brain health in young adulthood; namely, young adult brain capital. Increasing focus on younger populations is critical for developing citizens who are emotionally intelligent, resilient and can anticipate and cope with rapid changes in the world. By understanding the values that are key drivers and motivators for young adults, we can empower the next generation to become active agents in optimizing their brain health and reducing their risk for future ADRD.
In the European Union, the Chemicals Strategy for Sustainability (CSS) highlights the need to enhance the identification and assessment of substances of concern while reducing animal testing, thus fostering the development and use of New Approach Methodologies (NAMs) such as in silico, in vitro and in chemico. In the United States, the Tox21 strategy aims at shifting toxicological assessments away from traditional animal studies towards target-specific, mechanism-based and biological observations mainly obtained by using NAMs. Many other jurisdictions around the world are also increasing the use of NAMs. Hence, the provision of dedicated non-animal toxicological data and reporting formats as a basis for chemical risk assessment is necessary. Harmonising data reporting is crucial when aiming at re-using and sharing data for chemical risk assessment across jurisdictions. The OECD has developed a series of OECD Harmonised Templates (OHT), which are standard data formats designed for reporting information used for the risk assessment of chemicals relevant to their intrinsic properties, including effects on human health (e.g., toxicokinetics, skin sensitisation, repeated dose toxicity) and the environment (e.g., toxicity to test species and wildlife, biodegradation in soil, metabolism of residues in crops). The objective of this paper is to demonstrate the applicability of the OHT standard format for reporting information under various chemical risk assessment regimes, and to provide users with practical guidance on the use of OHT 201, in particular to report test results on intermediate effects and mechanistic information.
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