Expansion of the Low-Risk Substances in the Framework of the European Pesticide Regulation (EC) No 1107/2009

Signed in 2009, the plant protection Commission Regulation EC No 1107/2009 created a new category of active substances, the low-risk substances, with specific status defined in Article 22. The initial and specific criteria, not suitable for microorganisms and natural substances, were modified in 2018, and the first low-risk substance, allocating Part D of Regulation EC No 540/2011, was granted in the same year. Since then, thirty-three low-risk substances have been granted with this specific status through approvals and renewals, while a larger list of potential low-risk substances from already-approved active substances was published. This list is only exploited during renewals, and this process would take another five years to complete. After four years of the implementation of this status, the number of such substances is still low, but is intended to increase slowly. Two more low-risk substances are already pending in 2021, which will bring the number of low-risk substances to thirty-five, while the initial list of potential low-risk substances (only renewals) included fifty-seven substances.

Choosing Wisely Canada: Canadian Fertility and Andrology Society’s List of Top Items Physicians and Patients Should Question in Fertility Medicine

Purpose: To create a Choosing Wisely Canada list of the top 5 diagnostic and therapeutic interventions that should be questioned in Reproductive Endocrinology and Infertility in Canada.Methods: The Canadian Fertility and Andrology Society (CFAS) National Working Group developed an initial list of recommendations of diagnostic and therapeutic interventions that are commonly used, but are not supported by evidence, and could expose patients to unnecessary harm. These were chosen based on their prevalence, cost, potential for harm, and quality of supporting evidence. A modified Delphi consensus was used over 5 rounds to generate ideas, review supporting evidence, assess clinical relevance, estimate recommendation impact and narrow the recommendations list to 5 items. Results: Fifty unique ideas were first proposed by the working group, and after 5 rounds including a survey of Canadian Fertility and Andrology Society (CFAS) members, the final list of recommendations was created, including topics related to unnecessary investigations and interventions for patients with infertility and recurrent pregnancy loss, and those undergoing IVF. In this article, we describe not only the Delphi process used to determine the list, but also provide a summary of the evidence behind each of the final recommendations. Conclusions: The list of 5 recommendations highlights opportunities to initiate conversations between clinicians and patients about the risks, benefits, harms and costs of unnecessary fertility treatments and procedures in a Canadian context.

THE PECULIARITIES OF COMPILING THE “GERMAN-UKRAINIAN DICTIONARY OF TERMINOLOGY OF LIFE SAFETY”

The article deals with the principles of compiling the “German-Ukrainian Dictionary of Terminology of Life Safety” and selection pecularities of the lexical material such as the principles of compliance with the goals and objectives of learning, frequency, word-forming value of the term, associative value, subjectivity and semantics. Compilation of the dictionary involves many stages: analysis of existing dictionaries, research of the needs of the addressee, determination of requirements and future characteristics of the dictionary, development of its macro- and microstructure, collection of lexical material, design of dictionary articles, selection of translation equivalents, ordering of the dictionary in accordance with the developed structure, editing, checking the compliance of the received product with the set goals. The author offers the most productive and speed methods of compiling a dictionary with the help of BootCat generation program and Morphy program of paradigms synthesis, which allowed to single out 20,000 terms of the professional language of life safety in the shortest time and find their Ukrainian equivalents. The generation of a body of texts is carried out with S. Sharoff’s method, which provides the search for professional texts with the help of randomly combined four basic terms. This ensures the organization of a homogeneous selection of thematically related texts from the Internet (manuals, reference books, scientific articles, newspaper reports, instructions, sights, abstracts and annotations of articles, etc.). The obtained texts are processed with the help of the Morphy paradigm synthesis program, which automatically assigns all possible grammatical categories to each word in the sentence, and compiles the initial list of terminological dictionary. The next task is to provide equivalent words in the language of translation, able to accurately convey the semantics of the register word. Consequently, in the hands of the user of the dictionary, there is a certain linguistic model of the German professional language of life safety in its equivalent reproduction in the Ukrainian language. The presence of such an initial model will allow the user to perceive adequately scientific texts and, thus, successfully expand their scientific and conceptual apparatus in the future. Key words: dictionary, term, German professional language of life safety, terminological system, lexicography, synthesis of paradigms.

PP94 Pandemic Preparedness: EUnetHTA COVID-19 Rapid Response With “Rolling Collaborative Reviews (RCR)”

IntroductionPotential therapies and interventions for COVID-19 are emerging and developing rapidly. In a response to this public health emergency, the European Network for Health Technology Assessment (EUnetHTA) aims to support health policy in preparation for evidence-based purchasing. To monitor the emerging evidence, a new EUnetHTA product was created: Rolling Collaborative Reviews (RCRs).MethodsRCRs are living documents that are descriptive in nature, updated monthly, and centrally coordinated. They are based on the following three sources of information: (i) published randomized controlled trials (RCTs) presented as a summary of efficacy and safety data (synthesized for a network meta-analysis conducted by the Department of Epidemiology Lazio Regional Health Service, Italy); (ii) published prospective observational studies for safety results, provided by the Map of COVID-19 Evidence conducted by the Norwegian Institute of Public Health, Norway; and (iii) RCTs registered in clinical trial registries (ClinicalTrials.gov, EudraCT Register, and the ISRCTN registry). Additionally, detailed stopping and starting rules were defined.ResultsAs of November 2020, 14 RCRs were ongoing. From the initial list of RCRs, one was suspended due to lacking effectiveness and two moved on to rapid collaborative reviews due to European Medicines Agency approvals. Four RCRs are updated on a bimonthly basis due to a lack of high-quality evidence, and five new RCRs will be started because of promising clinical studies.ConclusionsRCRs can be a means of providing timely and continuous policy support, but they require a high level of coordinated effort.

Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity

IntroductionIncreasingly more pregnant women are living with pre-existing multimorbidity (≥two long-term physical or mental health conditions). This may adversely affect maternal and offspring outcomes. This study aims to develop a core outcome set (COS) for maternal and offspring outcomes in pregnant women with pre-existing multimorbidity. It is intended for use in observational and interventional studies in all pregnancy settings.Methods and analysisWe propose a four stage study design: (1) systematic literature search, (2) focus groups, (3) Delphi surveys and (4) consensus group meeting. The study will be conducted from June 2021 to August 2022. First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted among (1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners) and (2) their healthcare/social care professionals to identify outcomes important to them. Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include (1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, (2) healthcare/social care professionals involved in their care and (3) researchers in this field.Ethics and disseminationThis study has been approved by the University of Birmingham’s ethical review committee. The final COS will be disseminated through peer-reviewed publication and conferences and to all stakeholders.

Sustainable development goals: a framework for deploying indicators for higher education institutions

Purpose This paper aims to analyse the extent to which the sustainable development goals (SDGs) are being considered at higher education institutions (HEIs) and propose and test the possible acceptance of a list of indicators to evaluate the contribution of HEIs to the SDGs. Design/methodology/approach The methodology consisted of the collection of indicators of sustainable development based on the existing bibliography. Afterwards, a set of indicators related to the SDGs were selected, based on the most frequent SDGs’ expressions found in the selected indicators. A sample of researchers was also asked to indicate to which extent this set of indicators is perceived as relevant. Findings The results indicated an initial list with 432 indicators, of which 268 were selected for having at least one of the keywords searched for, related to the SDG descriptions and targets. Thus, redundant indicators were excluded and, when necessary, indicators were aggregated, resulting in a final list of 61 indicators. Originality/value The set of indicators resulted from this analysis was considered appropriate to evaluate the contribution of HEIs towards the SDGs, demonstrating that it might not be necessary to create new indicators for that purpose.

Development of entrustable professional activities for residents rotating nephrology department in a Japanese university hospital: a Delphi study

ObjectivesTraining strategies regarding entrustable professional activities (EPAs) vary from country to country; one such strategy is for residents. However, there are no reports of EPAs developed for residents who rotate to the nephrology departments. We aimed to construct such EPAs, which could be generalised to other institutions.DesignPurposive design and a modified Delphi method to build consensus.SettingThe department of nephrology in a university hospital in Aichi Prefecture, Japan.ParticipantsBased on the attainment goals used in our department, an initial list was developed within the research group. The expert panel included 25 nephrologists from our affiliate hospital. Responses were based on a 5-point method and agreement was reached if both (A) and (B) were met: (A) mean≥4 with a SD <1; (B) more than 75% of respondents rated the item 4 or more. With agreement, the item was left for the next round. This round was repeated.ResultsAn initial list of 11 items was developed; after three Delphi rounds and revisions, eight items remained that were then established as the final EPAs. These items can serve as a list of goals to be reached by residents who rotate to the department of nephrology. The results indicated that most of the experts believed residents should be able to perform tasks deemed necessary or urgent for all physicians, such as those that deal with hyperkalaemia and heart failure.ConclusionsThe concept of EPAs enabled us to develop goals and evaluation criteria for residents’ training in nephrology. This study can serve as a springboard for future discussions and contribute to the development of resident education in nephrology.

A Novel Ensemble Based Recommendation Approach using Network Based Analysis for Identification of Effective Drugs for Tuberculosis

Tuberculosis (TB) is a fatal infectious disease which affected millions of people worldwide for many decades and now with mutating drug resistant strains, it poses bigger challenges in treatment of the patients. Computational techniques might play a crucial role in rapidly developing new or modified anti-tuberculosis drugs which can tackle these mutating strains of TB. This research work applied a computational approach to generate a unique recommendation list of possible TB drugs as an alternate to a popular drug, EMB, by first securing an initial list of drugs from a popular online database, PubChem, and thereafter applying an ensemble of ranking mechanisms. As a novelty, both the pharmacokinetic properties and some network based attributes of the chemical structure of the drugs are considered for generating separate recommendation lists. The work also provides customized modifications on a popular and traditional ensemble ranking technique to cater to the specific dataset and requirements. The final recommendation list provides established chemical structures along with their ranks, which could be used as alternatives to EMB. It is believed that the incorporation of both pharmacokinetic and network based properties in the ensemble ranking process added to the effectiveness and relevance of the final recommendation.

Database technology for the masses

A wealth of technology has evolved around relational databases over decades that has been successfully tried and tested in many settings and use cases. Yet, the majority of it remains overlooked in the pursuit of performance (e.g., NoSQL) or new functionality (e.g., graph data or machine learning). In this paper, we argue that a wide range of techniques readily available in databases are crucial to tackling the challenges the IT industry faces in terms of hardware trends management, growing workloads, and the overall complexity of a rapidly changing application and platform landscape. However, to be truly useful, these techniques must be freed from the legacy component of database engines: relational operators. Therefore, we argue that to make databases more flexible as platforms and to extend their functionality to new data types and operations requires exposing a lower level of abstraction: instead of working with SQL it would be desirable for database engines to compile, optimize, and run a collection of sub-operators for manipulating and managing data, offering them as an external interface. In this paper, we discuss the advantages of this, provide an initial list of such sub-operators, and show how they can be used in practice.

Is it possible to scrutinize a relationship between a given pair of actors by performing a documentary scrutiny?

This is the exploratory stage of data used in a doctoral thesis that used social network analysis to scan relationships between actors with the aim of making the thesis that the exception regime in Brazil for 21 years, was already supported by a cohesive and robust of who shared an ideology. Through documentary research, a social network analysis was used in an innovative way when scrutinizing archives in the search for links between people in the period from 1964 to 1985. 374 people classified in the reports of the National Commission of Truth as responsible for human rights violations during the Dictatorship in Brazil. They are names of owners who made up an initial list of social actors to build the network of human rights violators. Through the construction of a matrix, associated with each author, it performed every fifteen events. To give depth, searches were made in the digital repositories of documents (such as their availability) for the following references: Projeto Brasil Nunca Mais de 1985, from the Archdiocese of São Paulo; National Archives and Brazilian Digital Library. With the findings, it was possible to conclude an exploratory stage with the following: It is possible to scan a relationship between a given pair of actors by conducting documentary scrutiny.