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The article discusses the possibility of using digital platforms for environmental management. The aim of the research is to determine the directions of using digital platforms for environmental management. To preserve the environment, increase energy conservation and sustainable development of territories, effective management is always important. Digital innovation allows citizens to engage, develop environmental volunteering, improve environmental literacy, collect more environmental data, and improve governance. The work identified the types of digital platforms depending on the subject of management, the main types of digital platforms and the main type of activity based on the chosen platform. The article considered the main digital platforms for environmental management in the field of ecology and the environment of the Russian Federation, highlighted the main functions of the platforms, problems and development directions. It is necessary to create such hybrid systems of environmental supervision in the field of water resources protection, to detect the facts of illegal construction and violation of construction parameters, remote control over the intended use of land, deforestation, and the environmental situation in water and air.

The goal of the research is to determine the importance and relevance of youth labor potential management for the environmental industry, as well as to determine the factors and risks that affect the environmental management of labor potential. To conduct the study, analytical, statistical, comparative methods, the grouping method were used, an analysis of statistical data on the number and structure of youth was carried out, as well as an analysis of current trends, factors, risks that affect the management of the labor potential of youth in the environmental industry. The main modern factors are highlighted: population aging; disproportionate distribution of the number of young people by country; the quality of youth vocational training and education; high speed of development of digital technologies in the economy. The risks posed by digital technologies are considered separately: increasing environmental risks and requirements for the level of environmental management; high speed and unpredictability of changes; inconsistent employment; platform approach; the requirement for the study of new technologies; the structure of personnel needs is changing: the level of requirements more and more does not correspond to the level of young personnel, and the rate of change in requirements is changing faster than educational programs; labor automation leads to job cuts; digital autism and decline in professional social and intellectual skills; digital addiction.

Currently, the economic systems of developed countries are undergoing structural transformations associated with the deployment of a new environmentally oriented industrial sector on a new technological environmentally friendly basis. For technologically catching-up countries, including those focused on the extraction of natural resources, the task is to critically understand the modification of this trend, since the deindustrialization processes led to the loss of many modern manufacturing industries, which resulted in a deep import dependence on resource-saving technologies and equipment. This results in the wasteful use of the resource base of the economy and the lack of recycling, in increasing pollution and lagging behind in terms of environmental industrial technologies. Ineffective institutions and international financial and technological restrictions reduce the effect of stimulating environmental import substitution by the state, hinder the development of its reproductive mechanisms that can provide a positive trend in economic dynamics. Therefore, the development of environmental import substitution, integrating the resource availability of the economy and environmental imperatives, technologies for the careful use of resources and their recycling, determines the prospects for sustainable development of the economy as a whole.

Abstract Background Lifestyle interventions are key to the control of diabetes and the prevention of complications, especially when used with pharmacological interventions. This protocol aims to review the effectiveness of lifestyle interventions in relation to nutrition and physical activity within the West African region. This systematic review and meta-analysis seeks to understand which interventions for lifestyle modification are implemented for the control of diabetes in West Africa at the individual and community level, what evidence is available on their effectiveness in improving glycaemic control and why these interventions were effective. Methods We will review randomised control trials and quasi-experimental designs on interventions relating to physical activity and nutrition in West Africa. Language will be restricted to English and French as these are the most widely spoken languages in the region. No other filters will be applied. Searching will involve four electronic databases — PubMed, Scopus, Africa Journals Online and Cairn.info using natural-language phrases plus reference/citation checking. Two reviewers will independently screen results according to titles and abstracts against the inclusion and exclusion criteria to identify eligible studies. Upon full-text review, all selected studies will be assessed using Cochrane’s Collaboration tool for assessing the risk of bias of a study and the ROBINS-I tool before data extraction. Evidence will be synthesised narratively and statistically where appropriate. We will conduct a meta-analysis when the interventions and contexts are similar enough for pooling and compare the treatment effects of the interventions in rural to urban settings and short term to long term wherever possible. Discussion We anticipate finding a number of studies missed by previous reviews and providing evidence of the effectiveness of different nutrition and physical activity interventions within the context of West Africa. This knowledge will support practitioners and policymakers in the design of interventions that are fit for context and purpose within the West African region. Systematic review registration This systematic review has been registered in the International Prospective Register for Systematic Reviews — PROSPERO, with registration number CRD42023435116. All amendments to this protocol during the process of the review will be explained accordingly.

In the past two years, the idea of a green economy has been widely discussed by not only environmental experts, but also various economic researchers. It is increasingly mentioned by heads of state and finance ministers, as well as in joint statements by the G20 and discussed in the context of sustainable development and fight against environmental damage. The current increase in relevance of the green economy concept is undoubtedly fueled by growing disappointment in the most widespread economic model, as well as the feeling of fatigue generated by the many crises and environmental failures that have been observed during the first two decades of the new century. The transition to a green economy has a solid economic and social justification. Convincing arguments are emerging in favor of doubling the efforts of both the state and the private sector towards to green economy transformation. In this regard, the state is faced with the task of leveling the rules for green products by refusing to provide obsolete subsidies, reforming policies and creating new incentives, strengthening ecological infrastructure and economic mechanisms, redirecting public investment and moving to green public procurement.

The article discusses the structure of city environmental management, regulatory documents, environmental monitoring system, the consequences of environmental policy at the local and regional levels, including cost analysis associated with the implementation of the city’s environmental strategies.

The article studies the problems of the public and business in the field of development of environmental initiatives and the problems of interaction with the municipal environmental management. The research was conducted in the tourist city of Russia, where ecology is of great importance for the development of tourism. The regulatory legal acts of the city and the municipal environmental management system were researched. A survey was also conducted of public organizations and businesses, which in the city became the initiators and participants of environmental projects. The research confirmed that there are problems highlighted by the public and business in the development of environmental initiatives in collaboration with municipal environmental management. Some problems create obstacles to the development of initiatives and reduce the level of business’s desire to spend their time and resources in the field of ecology. The initiatives of business and the public were ahead of the legislation both at the state level and at the municipal level. These initiatives made it possible to organize work to promote the environmental literacy of the population and separate waste collection. The absence of a system of interaction with organizations involved in environmental activities and responsible for this system of the post, the lack of educational work in the field of environmental literacy of the population and representatives of the city administration, the lack of a single information resource in the field of ecology and environmental initiatives of the city have a negative impact on the number of city initiatives in the field of ecology., insufficient education and clarification in the implementation of state legislation in the field of ecologic and separate waste collection.

Biofertilizers, consisting of carefully selected microorganisms across various species and genera, exhibit distinct features that enhance soil fertility and promote plant growth. Embracing the principles of eco-friendly agriculture, the use of biofertilizers emerges as a pivotal strategy for sustainable farming, contributing to environmental preservation and the overall health and biodiversity of the soil. In this study, a commercially available biofertilizer, containing a specialized strain of Priestia megatherium with nitrogen-fixing capabilities, was employed alongside chemical fertilizers at two different doses (30 and 40 mg per kg of soil). The primary objective was to evaluate the impact of biofertilizer on the metabolic activity and structure of microbial communities in a short-term experiment involving potted maize plants, utilizing the BIOLOG® EcoPlates technique. Parameters such as average well-color development (AWCD) and substrate utilization across six guilds (SAWCD) were assessed to gauge microbial metabolic activity. Additionally, functional indexes, including Shannon diversity, Shannon evenness, and Simpson diversity, were calculated as indicators of soil microbial community functionality. While statistically significant differences in AWCD among the studied variants were not observed, all estimated functional indexes consistently revealed heightened microbial diversity and evenness following the application of biofertilizer. This noteworthy finding, achieved within a relatively short period of plant cultivation, underscores the necessity for further research to explore the biofertilizer's enduring effects on soil communities, both in controlled laboratory environments and under real-world field conditions.

The article analyses media consumption trends in Ukraine in 2022-2024, a hugely difficult time for the nation during the full-scale invasion of Russia into Ukraine. During this time, both the consumers and the media had to adapt to new media conditions. The article analyzes the dynamics of media consumption in Ukraine during the last two years of the war in order to understand how extreme conditions in society affect the information environment, behavior, and psychological state of consumers. In the future, this will make it possible to develop effective strategies for media educational institutions and psychologists in shaping the conscious consumption of information and providing quality support to the individual in conditions of psychological crisis and emotional decline after contact with the media. The study’s results show that for the second year in a row, Ukrainians choose social networks and online media to receive news information. Telegram channels are leading. Moreover, conscious media consumption of Ukrainian and patriotic content is growing. The author emphasizes that the constant flow of news about war, shelling, misinformation, and propaganda exerts emotional pressure on consumers. Despite information overload, Ukrainians need quality and interesting content. In 2023, the consumption of entertainment programs, podcasts, and other formats that offer emotional enrichment to the consumer has increased significantly. Therefore, there is a growing need for psychological support and media programs to help consumers navigate the information space and support them with content in difficult times. Another important trend is the growing popularity of the concept of «ecological media consumption,» which involves conscious information selection, critical thinking, and minimizing the negative impact of media on the consumer’s mental health.

Rubus L. species (Rosaceae) are traditionally used worldwide for their food and medicinal properties. Although raspberries and blackberries are well-known fruits, the leaves hold significant but often overlooked value. The review is focused on the phytochemicals and pharmacological studies on leaves from the most promising taxa. Through a comprehensive search of the MEDLINE, Scopus, and Web of Science databases, numerous research articles were identified. The studies revealed over 160 diterpenoids, triterpenoid acids, saponins, ellagitannins, phenolic and acylquinic acids, and flavonoids in the discussed Rubus species. These compounds contribute to the leaves’ protective effects, including astringent, hypoglycemic, and wound healing activity. Moreover, Rubus leaves are used for relieving diarrhea as well as in the treatment of ulcerative colitis, owing to their anti-inflammatory and antioxidant properties. This review highlights R. sanctus, R. ibericus, and R. chingii, along with R. idaeus, as prospective raw materials for therapeutic applications.

Abstract Background Mersey Care NHS Foundation Trust’s Life Rooms initiative is an established and successful model of integrating arts and culture within NHS provision. In the face of COVID-19, the Life Rooms was restructured to provide a full suite of online resources. Following the lifting of restrictions, in-person arts provision returned to the Life Rooms sites. Additional evidence in respect of the impact on mental health and wellbeing of the return to in-person arts and cultural activities provided by the Life Rooms, as well as the relative merits of online and in-person arts and cultural activities, is needed to inform future planning around in-person, online, and/or hybrid provision. Methods Interviews with practitioners delivering cultural and creative courses at the Life Rooms (n = 8) and users of the Life Rooms (n = 5) were conducted to explore the impact of the return to in-person arts provision at the Life Rooms, as well as the merits of online and in-person arts provision. Data were analysed using thematic analysis. Results Three overarching themes were identified: ‘Provision, access, and reach’; ‘Value of arts and creativity’; and ‘Challenges with the Life Rooms model in the new normal’. The findings demonstrate the critical role of arts and cultural provision in providing stigma-free environments to reconnect the vulnerable and isolated. As re-engagement remained slow, there is a need to be responsive to hesitation around re-engaging in-person. The Life Rooms online learning offer remained vital for those who are vulnerable or otherwise unable to access in-person activities. Conclusions As our findings show a demand for maintaining online provision that enables accessibility together with in-person provision that boosts community connectedness, ensuring continued online access alongside in-person delivery should be prioritised. As mental health demands could continue to grow in coming years as the pandemic evolves, in-person arts engagement could have an important role in meeting mental health needs.

Abstract Background Health is increasingly affected by multiple types of crises. Community engagement is recognised as being a critical element in successful crisis response, and a number of conceptual frameworks and global guideline documents have been produced. However, little is known about the usefulness of such documents and whether they contain sufficient information to guide effective community engagement in crisis response. We undertake a scoping review to examine the usefulness of conceptual literature and official guidelines on community engagement in crisis response using a realist-informed analysis [exploring contexts, mechanisms, and outcomes(CMOs)]. Specifically, we assess the extent to which sufficient detail is provided on specific health crisis contexts, the range of mechanisms (actions) that are developed and employed to engage communities in crisis response and the outcomes achieved. We also consider the extent of analysis of interactions between the mechanisms and contexts which can explain whether successful outcomes are achieved or not. Scope and findings We retained 30 documents from a total of 10,780 initially identified. Our analysis found that available evidence on context, mechanism and outcomes on community engagement in crisis response, or some of their elements, was promising, but few documents provided details on all three and even fewer were able to show evidence of the interactions between these categories, thus leaving gaps in understanding how to successfully engage communities in crisis response to secure impactful outcomes. There is evidence that involving community members in all the steps of response increases community resilience and helps to build trust. Consistent communication with the communities in time of crisis is the key for effective responses and helps to improve health indicators by avoiding preventable deaths. Conclusions Our analysis confirms the complexity of successful community engagement and the need for strategies that help to deal with this complexity to achieve good health outcomes. Further primary research is needed to answer questions of how and why specific mechanisms, in particular contexts, can lead to positive outcomes, including what works and what does not work and how to measure these processes.

The effectiveness of fractional application of nitrogen fertilizers in cultivation of spring common wheat was studied in the conditions of the Omsk Irtysh region on meadow-chernozem medium-sized medium-humus heavy loamy soil. The research object was spring common wheat (Triticum aestivum L.) cv. Melodiya. The purpose of the research was to establish the effectiveness of fractional application of nitrogen fertilizers depending on the level of labile phosphorus in meadow-chernozem soil on yield and grain quality of spring common wheat in the conditions of the Omsk Irtysh region. The field experiment had three factors (242): Factor A phosphorus background: 1. No fertilizers; 2. Application of P30 a. i./ha; factor B main application of ammonium nitrate in increasing doses: 0, N30, N45, N60; factor C foliar feeding with ammonium nitrate and carbamide at a dose of N30: 1. Once in heading stage; 2. Twice in heading stage and milky ripeness. It was found that the most effective was main application of nitrogen-p hosphorus fertilizers in doses of N3045P30; crop productivity in these variants increases by 4048 % in comparison with the nonfertilized variants due to the gain in 1000-seed weight (r = 0.400.42), productive stooling (r = 0.83). The agronomic profitableness of one kg of a. i./ha applied fertilizers in these variants was 21.5 and 19.9 kg of grain with 7.5 and 6.1 kg increase in protein content, respectively. Late foliar sprayings, regardless of their number, did not increase crop productivity and quality of wheat grain. Thus, fractional application of nitrogen fertilizers in years with insufficient moisture levels (hydrothermal index 0.60.7) is not effective.

The paper considers current taxation problems in cross-border electronic commerce in goods, theshare of which in total trade continues to grow. Considering the field of economics as a part ofuniversity education, which can play a prominent role in solving the current problems, we suggestspossible ways of regulating the cross-border e-commerce taxation by involving digital platforms inthe taxation process and making them fully or partially liable for tax obligations. In addition, theestablishment of university educational courses in the field of economics has been proposed as away to improve the economic situation.

As part of rental-resource model and access restrictions to capital and new technologies, the attempts to encourage import substitution made by the government do not generate innovative type of economic development and reconstruction of economy’s manufacturing industry competitive on the domestic market. In conditions of searching for a new model of Russian economy development the analysis of a number of problems such as industry degradation, reducing the competitiveness of Russian producers, the growth of structural imbalances and overcoming the negative macroeconomic trends becomes strategically important. This raises the value of neo-industrialization as the integrator of resource security, scientific and industrial potential of Russian economy and high capacity of the domestic market in the innovative development system. A special role neo-industrialization plays for the economic development of old industrial regions, which include Kuzbass (Western Siberia, Russia). Neo-industrial development of Kuzbass economy should be initiated by the technological modernization of mining machinery and innovative development of coal industry.

Background Syrian refugees have a high burden of mental health symptoms and face challenges in accessing mental health and psychosocial support (MHPSS). This study assesses health system responsiveness (HSR) to the MHPSS needs of Syrian refugees, comparing countries in Europe and the Middle East to inform recommendations for strengthening MHPSS systems Methods A mixed-methods rapid appraisal methodology guided by an adapted WHO Health System Framework was used to assess HSR in eight countries (Egypt, Germany, Jordan, Lebanon, Netherlands, Sweden, Switzerland, and Türkiye). Quantitative and qualitative analysis of primary and secondary data was used. Data collection and analysis were performed iteratively by multiple researchers. Country reports were used for comparative analysis and synthesis. Results We found numerous constraints in HSR: i) Too few appropriate mental health providers and services; ii) Travel-related barriers impeding access to services, widening rural-urban inequalities in the distribution of mental health workers; iii) Cultural, language, and knowledge-related barriers to timely care likely caused by insufficient numbers of culturally sensitive providers, costs of professional interpreters, somatic presentations of distress by Syrian refugees, limited mental health awareness, and stigma associated to mental illness; iv) High out-of-pocket costs for psychological treatment and transportation to services reducing affordability, particularly in middle-income countries; v) Long waiting times for specialist mental health services; vi) Information gaps on the mental health needs of refugees and responsiveness of MHPSS systems in all countries. Six recommendations are provided to address these issues. Conclusions All eight host countries struggle to provide responsive MHPSS to Syrian refugees. Strengthening the mental health workforce (in terms of quantity, quality, diversity, and distribution) is urgently needed to enable Syrian refugees to receive culturally appropriate and timely care and improve mental health outcomes. Increased financial investment in mental health and improved health information systems are crucial.

Background Informal payments for healthcare are typically regressive and limit access to quality healthcare while increasing risk of catastrophic health expenditure, especially in developing countries. Different responses have been proposed, but little is known about how they influence the incentives driving this behaviour. We therefore identified providers’ preferences for policy interventions to overcome informal payments in Tanzania.Methods We undertook a discrete choice experiment (DCE) to elicit preferences over various policy options with 432 health providers in 42 public health facilities in Pwani and Dar es Salaam region. DCE attributes were derived from a multi-stage process including a literature review, qualitative interviews with key informants, a workshop with health stakeholders, expert opinions, and a pilot test. Each respondent received 12 unlabelled choice sets describing two hypothetical job-settings that varied across 6-attributes: mode of payment, supervision at facility, opportunity for private practice, awareness and monitoring, measures against informal payments, and incentive payments to encourage noninfraction. Mixed multinomial logit (MMNL) models were used for estimation.Results All attributes, apart from supervision at facility, significantly influenced providers’ choices (P < .001). Health providers strongly and significantly preferred incentive payments for non-infraction and opportunities for private practice, but significantly disliked disciplinary measures at district level. Preferences varied across the sample, although all groups significantly preferred the opportunity to practice privately and cashless payment. Disciplinary measures at district level were significantly disliked by unit in-charges, those who never engaged in informal payments, and who were not absent from work for official trip. 10% salary top-up were preferred incentive by all, except those who engaged in informal payments and absent from work for official trip.Conclusion Better working conditions, with improved earnings and career paths, were strongly preferred by all, different respondents groups had distinct preferences according to their characteristics, suggesting the need for adoption of tailored packages of interventions.

Purslane (Portulaca oleracea L., Portulacaceae) is a widespread edible plant with significant ethnobotanical and ethnopharmacological importance. The plant is characteristic for the presence of a class of indoline amide glucoside alkaloids, called cyclo-dopa amides, or oleraceins. Additionally, a new, structurally similar to oleraceins, class of indole amides have been discovered recently, called oleraindoles. These compounds have been evaluated to possess antiinflammatory and anticholinesterase activities. Herein, utilizing UHPLC-Orbitrap-MS with MS2 filtering by diagnostic ion filtering (DIF), and diagnostic difference filtering (DDF) using different data analysis tools, eight compounds with oleraindole structure were tentatively identified.

The high-fat (HF) diets can be used to generate a valid rodent model for metabolic syndrome (METS). The aim of this study was to compare three different diets, namely a high-fat, high-carbohydrate diet (HF-HCD), a high-fat lard-based diet (HFD), and a cafeteria diet (CFD), in terms of the ability to induce METS. The next step was to characterize the syndrome according to the biochemical and histopathological changes in the liver and pancreas, and to determine the optimal animal model. As a result, all diets disturbed significantly the serum biochemical parameters. HF-HCD and CFD increased the uric acid levels and reduced the weight gain in comparison with the standard chow diet (SCD) and HFD. The HFD and CFD induced the highest fasting glycemia levels. Although the animals fed with HF-HCD had the lowest body weight, the most serious histopathological changes in the pancreas, hypertension, and oxidative stress were noted in them.

Abstract The 2013–2016 West Africa Ebola Epidemic is the largest outbreak of Ebola in history. By September, 2014 the outbreak was worsening significantly, and the international president of Médecins Sans Frontières called for military assistance. In Sierra Leone, the British and Sierra Leonean militaries intervened. They quickly established a National Ebola Response Centre and a constituent network of District Ebola Response Centres. Thereafter, these inherently militarised centres are where almost all Ebola response activities were coordinated. In order to examine perspectives on the nature of the militaries’ intervention, 110 semi-structured qualitative interviews were conducted and analysed. Military support to Sierra Leone’s Ebola response was felt by most respondents to be a valuable contribution to the overall effort to contain the outbreak, especially in light of the perceived weakness of the Ministry of Health and Sanitation to effectively do so. However, a smaller number of respondents emphasised that the military deployments facilitated various structural harms, including for how the perceived exclusion of public institutions (as above) and other local actors from Ebola response decision making was felt to prevent capacity building, and in turn, to limit resilience to future crises. The concurrent provision of life-saving assistance and rendering of structural harm resulting from the militaries’ intervention is ultimately found to be part of a vicious cycle, which this article conceptualises as the ‘political economy of expedience’, a paradox that should be considered inherent in any militarised intervention during humanitarian and public health crises.

Pelargonium graveolens L’Hèr. (Geraniaceae) is renowned for its traditional use as a flavor, ornamental and medicinal plant. This work aimed at an in-depth study of the phytochemical profiling and in vitro antioxidant and enzyme inhibition assessment of a methanol-aqueous extract from P. graveolens leaves. A UHPLC-HRMS analysis revealed more than 110 secondary metabolites, including 8 acyltartaric and 11 acylcitric/acylisocitric acids; 8 gallotannins; 36 flavonols, flavanones and methoxylated flavonoids together with 17 phenolic and aliphatic acids; and 21 phenolic acid glycosides. For the first time, acylcitric acids along with feruloyl- and coumaroyltartaric acids are reported in the species. The leaf extract actively scavenged 2,2-diphenyl-1-picrylhydrazyl DPPH (273.45 mg trolox equivalent (TE/g)) and 2,2′-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS•+) radicals (531.97 mgTE/g) and showed a high reducing power: 431.32 mg TE/g Cupric reducing antioxidant capacity (CUPRAC) and 292.21 mg TE/g Ferric reducing antioxidant power (FRAP). It possessed a metal chelating capacity (13.44 ethylenediaminetetraacetic acid equivalent (EDTAE)/g) and contained 2.71 mmol TE/g in the phosphomolybdenum assay. The rose geranium extract exhibited high inhibition towards acetyl- and butyrylcholinesterase (2.80 and 2.20 mg galantamine equivalent (GALAE)/g, respectively) and tyrosinase (75.49 mg kojic acid equivalent (KAE)/g). It inhibited α-glucosidase and α-amylase (3.75 mmol and 0.79 acarbose equivalent (ACAE)/g, respectively) and lipase (28.91 mg orlistat equivalent (OE)/g). This study sheds light into the future potential application of the rose geranium in pharmaceutical and nutraceutical products.

In the paper, personalized results are presented in the methodology for monitoring information security based on voice authentication. Integration of sound preprocessing and Machine Learning techniques for feature extraction, training, and validation of classification models has been implemented. The objects of research are staked mixed-test voice profiles. Classifies were selected with quantitative evaluation under a threshold of 90.00% by Naive Bayes and Discriminant Analysis. Significantly improved accuracy to approximate levels of 96.0% was established at Decision Tree synthesis. Strongly satisfactory performance indices were reached at the diagnosis of voice profiles using Feed-Forward and Probabilistic Neural Networks, respectively, 98.00% and 100.00%.

Objectives To describe opportunities and challenges experienced from the four pharmacoepidemiological database studies included in the rivaroxaban post authorisation safety study (PASS) programme and propose ways to maximise the value of population-based observational research when addressing regulatory requirements.Design PASS programme of rivaroxaban carried out as part of the regulatory postapproval commitment to the European Medicines Agency.Setting Clinical practice in Germany, the Netherlands, Sweden and the UK (electronic health records)—undertaken by pharmacoepidemiology research teams using country-specific databases with different coding structures.Participants 355 152 patients prescribed rivaroxaban and 338 199 patients prescribed vitamin K antagonists.Results Two major challenges that were encountered throughout the lengthy PASS programme were related to: (1) finalising country-tailored study designs before the extent of rivaroxaban uptake was known, and (2) new research questions that arose during the programme (eg, those relating to an evolving prescribing landscape).Recommendations We advocate the following strategies to help address these major challenges (should they arise in any future PASS): conducting studies based on a common data model that enable the same analytical tools to be applied when using different databases; maintaining early, clear, continuous communication with the regulator (including discussing the potential benefit of studying drug use as a precursor to planning a safety study); consideration of adaptive designs whenever uncertainty exists and following an initial period of data collection; and setting milestones for the review of study objectives.