Current Good Practice Research Articles

Outpatient Parenteral Antimicrobial Therapy Practice in United Kingdom: A Single-center Experience.

This study sought to analyze the outpatient parenteral antimicrobial therapy (OPAT) services provided by a tertiary hospital, in terms of types and duration of antimicrobials administered, and assess whether these services were in line with current good practice recommendations. The electronic healthcare records of all stable patients with infectious diseases, aged ≥ 18 years, who received OPAT services between January 2019 and March 2021, were analyzed. For statistical analysis, the patients were divided into younger (< 65 years) and older (≥ 65 years) adults and the difference between them, in terms of healthcare resources utilization, was assessed. Over 27 months, 199 patients received OPAT services, resulting in saving of 7514 bed-days. Bone and joint infections (38.7%) were the predominant diagnoses. The median actual OPAT duration was significantly greater than the planned duration for the total study population, younger adults, and older adults (p < 0.050). Of 28 (14.1%) patients with adverse events, 25 were related to antimicrobials while the remaining three were associated with catheters. There were no significant differences between younger and older adults in the characteristics evaluated, except for the higher incidence of Staphylococcus aureus (p < 0.001) and Escherichia coli, Staphylococcal spp., Streptococcal spp., and Pseudomonas spp. (p =0.003) infection in older adults. The actual median duration of OPAT therapy was significantly longer than planned, with suboptimal adherence to the principles of antimicrobial stewardship. OPAT has been shown to be safe for both younger and older adults.

The Development and Validation of a Child Safeguarding in Sport Self-assessment Tool for the Council of Europe

Abuse and interpersonal violence threaten participant safety and trust in sport. Many political and project activities have sought to promote safeguarding policies within national sporting structures. Despite this, implementation of safe sport policy measures has been lacklustre, and policy guidance is often disparate and sometimes contradictory. Against this background, the Council of Europe initiated the development of a safeguarding in sport self-assessment tool to assist national sport authorities in this crucial area. This tool addresses some of the gaps within safe sport policy guidance by summarising current good practices and offering policy guidance and legitimation. In the following Innovations article, we present our work developing the safeguarding self-assessment tool for national sport organisations in collaboration with the Council of Europe.

Infravec2 guidelines for the design and operation of containment level 2 and 3 insectaries in Europe

ABSTRACT With the current expansion of vector-based research and an increasing number of facilities rearing arthropod vectors and infecting them with pathogens, common measures for containment of arthropods as well as manipulation of pathogens are becoming essential for the design and running of such research facilities to ensure safe work and reproducibility, without compromising experimental feasibility. These guidelines and comments were written by experts of the Infravec2 consortium, a Horizon 2020-funded consortium integrating the most sophisticated European infrastructures for research on arthropod vectors of human and animal diseases. They reflect current good practice across European laboratories with experience of safely handling different mosquito species and the pathogens they transmit. As such, they provide experience-based advice to assess and manage the risks to work safely with mosquitoes and the pathogens they transmit. This document can also form the basis for research with other arthropods, for example, midges, ticks or sandflies, with some modification to reflect specific requirements.

Practice of Good Governance in Rajapur Municipality

Good governance is a vital part of the governing system based on conscious oriented and meaningful participation, followed by a legal system that is effective and efficient service delivery, accountable, transparent, responsive, equitable, and more inclusive. This study tries to explore the practice and policy of good governance in Rajapur Municipality. The theoretical underpinnings for the study are based on descriptive research design. The respondents are selected by purposive and convenience sampling methods. The interview and questionnaire were the main tools for gathering the required information. The study disclosed a low level of accountability and transparency in the Rajapur municipality. It is a case study of Rajapur Municipality. In conclusion, the current good governance practice of Rajapur Municipality is weak and identified with a high level of rent-seeking among public servants as well as appointed and elected authorities. This research claims for the existence of governance which guarantees public appointment in decision making and prioritization of shared problems, accompanied by the transparent and accountable government are recommendable

Spent fowl as a source of unintentional egg proteins exposure in Canadian food products

The occurrence of egg proteins in products containing spent fowl manufactured under current practices was studied to assess the risk these food products may pose to egg-allergic consumers and to determine if Precautionary Allergen Labelling (PAL) was recommended. Spent fowl slaughtering and processing operations in 2 Canadian facilities were observed. Raw hen pieces (n = 134), coming from 2 facilities, and intermediate and processed products containing spent fowl (n = 57), coming from one facility, were analyzed using ELISA. All samples tested positive for egg proteins. Raw pieces were tested using a qualitative method (i.e., swabbing); estimated egg proteins concentrations suggest the presence of highly contaminated samples (>600 mg/kg in 2 hen wing samples). Swabbing was found to be efficient for rapid detection of eggs in raw hen pieces, but not for quantification. A comparison between swab and grind results showed that egg proteins concentration is underestimated by at least a factor 2 for whole carcasses and a factor 10 for breast, wings and drumsticks, when using the swab protocol. For intermediate and processed products, quantitative measurements indicate that egg protein levels were below 16 mg/kg. Additionally, 88 water samples from chiller tanks were analyzed and indicate that this step could be the cause of the global contamination observed with an increase in egg protein concentrations overtime during the production schedule. As egg contamination is not adequately controlled under the current good production practices, the use of PAL would be recommended for raw spent fowl products.

Automatic generation of textual descriptions in data-to-text systems using a fuzzy temporal ontology: Application in air quality index data series

In this paper we present a model based on computational intelligence and natural language generation for the automatic generation of textual summaries from numerical data series, aiming to provide insights which help users to understand the relevant information hidden in the data. Our model includes a fuzzy temporal ontology with temporal references which addresses the problem of managing imprecise temporal knowledge, which is relevant in data series. We fully describe a real use case of application in the environmental information systems field, providing linguistic descriptions about the air quality index (AQI), which is a very well-known indicator provided by all meteorological agencies worldwide. We consider two different data sources of real AQI data provided by the official Galician (NW Spain) Meteorology Agency: (i) AQI distribution in the stations of the meteorological observation network and (ii) time series which describe the state and evolution of the AQI in each meteorological station. Both application models were evaluated following the current standards and good practices of manual human expert evaluation of the Natural Language Generation field. Assessment results by two experts meteorologists were very satisfactory, which empirically confirm that the proposed textual descriptions fit this type of data and service both in content and layout.

“Getting Ireland Active”—Application of a Systems Approach to Increase Physical Activity in Ireland Using the GAPPA Framework

Physical activity (PA) promotion is a complex challenge, with the Global Action Plan on Physical Activity (GAPPA) endorsing a systems approach and recommending countries assess existing areas of progress which can be strengthened. This paper reports a process facilitating a systems approach for identifying current good practice and gaps for promoting PA in Ireland. Elements of participatory action research were enabled through 3 stages: (1)aligning examples of actions from Irish policy documents (n = 3) to the GAPPA, (2)workshop with stakeholders across multiple sectors, and (3)review of outputs. Data collected through the workshop were analyzed using a deductive thematic analysis guided by the GAPPA. The policy context in Ireland aligns closely to the GAPPA with the creation of Active Systems the most common strategic objective across policy documents. Forty participants (50% male) took part in the systems approach workshop, which after revision resulted in 80 examples of good practice and 121 actions for greater impact. A pragmatic and replicable process facilitating a systems approach was adopted and showed current Irish policy and practices align with the GAPPA "good practices." The process provides existing areas of progress which can be strengthened, as well as the policy opportunities and practice gaps.

Adopting threat modelling in agile software development projects

The goal of secure software engineering is to create software that keeps performing as intended, even when exposed to attacks. Threat modelling is considered to be a key activity to reach this goal, but has turned out to be challenging to implement in agile teams. This paper presents results from four different studies, in which we have investigated how agile teams do threat modelling today. Study A is based on observations and document analysis from five teams in a single organisation, Study B is based on interviews with eight individuals from four different organisations, Study C is based on a questionnaire survey of 45 students at two different universities, and Study D is based on interviews with seven teams in a single organisation, supplemented with document analysis. Our results include findings, challenges and current good practice related to the use of Data Flow Diagrams, STRIDE and the Microsoft Threat Modelling Tool. We also cross-check our findings with previous relevant work, and provide recommendations for making the threat modelling activities more useful to agile teams.

The National Heart, Lung, and Blood Institute-funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy.

The Production Assistance for Cellular Therapies (PACT) Program, is funded and supported by the US Department of Health and Human Services’ National Institutes of Health (NIH) National Heart Lung and Blood Institute (NHLBI) to advance development of somatic cell and genetically modified cell therapeutics in the areas of heart, lung, and blood diseases. The program began in 2003, continued under two competitive renewals, and ended June 2021. PACT has supported cell therapy product manufacturing, investigational new drug enabling preclinical studies, and translational services, and has provided regulatory assistance for candidate cell therapy products that may aid in the repair and regeneration of damaged/diseased cells, tissues, and organs. PACT currently supports the development of novel cell therapies through five cell processing facilities. These facilities offer manufacturing processes, analytical development, technology transfer, process scale‐up, and preclinical development expertise necessary to produce cell therapy products that are compliant with Good Laboratory Practices, current Good Manufacturing Practices, and current Good Tissue Practices regulations. The Emmes Company, LLC, serves as the Coordinating Center and assists with the management and coordination of PACT and its application submission and review process. This paper discusses the impact and accomplishments of the PACT program on the cell therapy field and its evolution over the duration of the program. It highlights the work that has been accomplished and provides a foundation to build future programs with similar goals to advance cellular therapeutics in a coordinated and centralized programmatic manner to support unmet medical needs within NHLBI purview.

Applying the Realist Evaluation Approach to the Complex Process of Policy Implementation-The Case of the User Fee Exemption Policy for Cesarean Section in Benin.

Realist evaluation is making inroads in the field of health policy and systems research to a large extent because of its good fit with complex issues. Until now, most realist studies focused on evaluating interventions or projects related to health care delivery, organization of health services, education, management, and leadership of health workers in high income countries. With this paper, we apply the realist approach to the study of national health policy implementation in a low resource country. We use the case of the user fee exemption policy for cesarean section in Benin, which we followed up from 2009 to 2018. We report on how realist evaluation can be applied for policy implementation research. We illustrate how we developed the initial programme theory—the starting point of any realist evaluation -, how we designed the study and data collection tools, and how we analyzed the data. For each step, we present current good practices, how we adapted them when needed, the challenges and the lessons learned. We report also on how the dynamic interactions between the central level (the national implementing agency) and the peripheral level (an implementing hospital) shaped the policy implementation. We found that at central level, availability of resources for a given policy is constantly challenged in the competitive national resource allocation arena. Key factors include the political power and the legitimacy of the group supporting the policy. These are influenced by the policy implementation structure, how the actual outputs of the implementation align with promises of the group supporting the policy and consequently how these outputs, the policy and its promoters are perceived by the community. We found that the service providers are key to the implementation, and that they are constrained or influenced by the dependability of the funding, their autonomy, their personal background, and the accountability arrangements. This study can inform the design and implementation of national health policies that involve interactions between central and operational level in other low-income countries.

Spotlight on: guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals published in EJNMMI Radiopharmacy and Chemistry (2021)6:8

Spotlight on: guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals published in EJNMMI Radiopharmacy and Chemistry (2021)6:8

Experimental and Modeling Analyses of Human Motion Across the Static Magnetic Field of an MRI Scanner.

It is established that human movements in the vicinity of a permanent static magnetic field, such as those in magnetic resonance imaging (MRI) scanners induce electric fields in the human body; this raises potential severe risks of health to radiographers and cleaners exposed routinely to these fields in MRI rooms. The relevant directives and parameters, however, are based on theoretical models, and accurate studies on the simulation of the effects based on human movement data obtained in real conditions are still lacking. Two radiographers and one cleaner, familiar with MRI room activities and these directives, were gait analyzed during the execution of routine job motor tasks at different velocities. Full body motion was recorded in a gait laboratory arranged to reproduce the workspace of a room with an MRI full-body scanner. Body segments were tracked with clusters of at least three markers, from which position and velocity of the centroids were calculated. These were used as input in an established computer physical model able to map the stray field in an MRI room. The spatial peak values of the calculated electric field induced by motion of the head and of the entire body during these tasks, for both the health and sensory effects, were found smaller than the thresholds recommended by the European directives, for both 1.5 T and 3.0 T MRI. These tasks therefore seem to guarantee the safety of MRI room operators according to current professional good practice for exposure risks. Physical modeling and experimental measures of human motion can also support occupational medicine.

Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

This guideline on current good radiopharmacy practice (cGRPP) for small-scale preparation of radiopharmaceuticals represents the view of the Radiopharmacy Committee of the European Association of Nuclear Medicine (EANM). The guideline is laid out in the format of the EU Good Manufacturing Practice (GMP) guidelines as defined in EudraLex volume 4. It is intended for non-commercial sites such as hospital radiopharmacies, nuclear medicine departments, research PET centres and in general any healthcare establishments. In the first section, general aspects which are applicable to all levels of operations are discussed. The second section discusses the preparation of small-scale radiopharmaceuticals (SSRP) using licensed generators and kits. Finally, the third section goes into the more complex preparation of SSRP from non-licensed starting materials, often requiring a purification step and sterile filtration. The intention is that the guideline will assist radiopharmacies in the preparation of diagnostic and therapeutic SSRP’s safe for human administration.

Quality Management Systems (QMSs) of Human-Based Tissue and Cell Product Manufacturing Facilities.

In the broadest sense, a quality management system (QMS) runs by continuous interaction of elements based on processes, procedures, policies, guidelines, and resources that are compiled to guide an organization under the scope of its operational mission, vision, and objectives. QMSs in the biopharmaceutical sector defines a written and applied set of rules which aids in improvement of the quality of biopharmaceutical process engineering, while primarily assuring human tissue- and cell-based starting material and end product safety and minimizing the risk of human medicinal product recall, in the most cost-effective ways possible. This chapter aims to outline the crucial position of a QMS under the scope of good practices (GxPs) in the biopharmaceutical industry, as regards human tissue- and cell-based products.

Good Governance Practices and Challenges in Local Government of Ethiopia: The Case of Bonga Town Administration

This study sought to assess the practice and challenges of good governance in Bonga Town Administration. A descriptive research method was utilized. Respondents are selected by purposive and convenience sampling techniques. Quantitative data was gathered through a questionnaire. Pertinent to qualitative information, structured interview, and FGD are employed. Then, data analyzed through quantitative and qualitative methods. Finally, the study disclosed a low level of accountability and transparency in the town administration. Pervasive corruption is also perceived as a key governance problem in the town; however, due to fear of reprisal citizens lack experience in exposing corruption. In sum poor service delivery, the gap between local government representatives and the town people, high level of rent-seeking, weak political leadership, lack of timely response for a public interest, and public disengagement in shared affairs were found to be challenges of good governance. Henceforth, based on the findings, it is concluded that the current good governance practice in Bonga Town Administration is weak and identified with a high level of rent-seeking among public servants as well as appointed and elected authorities. This research argues for the existence of governance which ensures public engagement in decision making and prioritization of shared problems, accompanied by transparent and accountable administration.&#x0D;

The effect of field application of food‐based anaerobic digestate on earthworm populations

AbstractIn general, farming systems that provide the greatest organic matter returns to the soil support the highest earthworm populations and typically the application of organic materials will increase earthworm numbers because of an abundance of food. There has been limited work on the effects of digestate applications on earthworm populations with most focus on the short‐term effects of digestate from manure or crop‐based feedstocks, not from food wastes. To address this gap in current knowledge, the objective of this study was to assess the impact of repeated food‐based digestate applications on earthworm populations/biomass in both the short term (c. 6 months after digestate application) and longer term (2 years later) in comparison with other commonly used inputs (manufactured nitrogen‐N fertilizer, compost and livestock manures). This multi‐site field experiment has shown that the application of food‐based digestate at application rates above current good practice can have a short‐term, negative impact on earthworm numbers under certain conditions. Six months after the final digestate addition, earthworm numbers were 32%–60% lower than following the additions of other organic materials at four of the seven sites investigated. A combination of high ammonium/low organic matter loadings and soil compaction most likely explained the observed effects.

Costa Rican Education Supports for Youth With Disabilities Within Correctional Confinement

Costa Rica has developed a modality for people in vulnerable conditions to remain in the education system called Educación Abierta, Spanish for “Open Education.” This modality is described, and a lack of specific research is identified regarding minors with a disability and deprived of liberty. This article acknowledges the current good practices on local educational programs for this population, as well as the challenges that are still to be faced regarding diagnosis and intervention strategies within Centro de Formación Juvenil Zurquí for students with attention deficit and hyperactivity disorder, dyslexia, and dyscalculia, among others.

Priorities for improving chemicals management in the WHO European Region-stakeholders' views.

BackgroundPrevention of the impact of chemicals on human health and the environment is an increasing focus of public health polices and policy makers. The World Health Organization European Centre for Environment and Health wanted to know what were stakeholders’ priorities for improving chemicals management and prevention.MethodsSemi-structured interviews were undertaken with 18 diverse stakeholders to answer this question. The interview questionnaire was developed using current WHO chemical meeting reports, the Evidence Implementation Model for Public Health Systems and categories of the theory of diffusion. Stakeholder views were attained on three main questions within the questionnaire. (i) What priority actions should be undertaken to minimize the negative impact of chemicals? (ii) Who needs to be more involved and what roles should they have? (iii) How can science and knowledge on chemicals and health be translated into policies more effectively and what are the greatest barriers to overcome?ResultsCross cutting issues, such as legislation strengthening and enforcement, further collection of information, capacity building, education and awareness raising were considered priorities. The responders had the same vision on roles and responsibilities of different stakeholders. The greatest barrier to adoption, implementation and enforcement of evidence-based policies reported was leadership and political commitment to chemical safety.ConclusionsPriorities raised differed depending on knowledge, professional background and type of stakeholder. Factors influencing priority identification at the national level include international and global context, availability of information, knowledge of the current situation and evidence-based good practice, and risks and priorities identified through national assessments.

Solid organ xenotransplantation at the interface between research and clinical development: Regulatory aspects.

During the last years, progress has been made in survival and function of pig-to-non-human primate organ xenotransplantation using organs from genetically modified pigs and immunosuppression regimens that are clinically acceptable. This, together with increased insights into a low risk of pig-to-human transmission of porcine endogenous retrovirus, has opened the perspective of starting with first-in-human trials with xenogeneic organs. The regulatory path to clinical development is complex. Unlike an organ from human donors, an organ from pigs, either genetically modified or wild-type pigs, is considered a medicinal product for human use and hence is under regulatory oversight, in the United States by the Food and Drug Administration and in Europe by the national competent authorities of the member states as well as the European Medicines Agency. Related to the status of medicinal product, "(current) good practices" apply in the process of generating a xenogeneic organ through to the transplantation into a patient and life-long follow-up. In addition, guidances for xenotransplantation products and genetically modified organisms do apply as well. This commentary focuses on regulatory aspects of transplantation of organs from genetically modified pigs into humans, with the intention to facilitate the interactions between regulatory agencies and institutions (sponsors) in research and clinical development of these organs, to support the perspective of speeding up the process with a proper entry in clinical application, to fill an unmet medical need in patients with end-stage organ disease.

Cyber security and the disaster resilience framework

PurposeThe purpose of this paper is to concentrate on the place of cyber security risk in the framework of global commitments adopted in 2015 to reduce disaster risks in an all-hazards approach. It explores the correlations between traditional risks associated with critical infrastructures – as understood by the Sendai framework – cyber security risks and the cascading effects characteristic of today’s complex and interrelated shocks and stresses. It takes a step further, expanding the focus of traditionally understood technological risks to explore cyber security risks, at the heart of our societies’ digital transformations,and showcase opportunities from the European context.Design/methodology/approachBy reviewing existing literature on cyber security, disaster resilience and cascading disasters, this paper highlights current challenges and good practices undertaken by various governments.FindingsUnderstanding disaster risks is a precondition to improving the mitigation of impacts of existing risks and preventing new risks. Effective risk reduction relies on a solid understanding of losses resulting from events to inform future actions, and on the assessment of risks relying on a robust evidence base and state-of-the-art scientific capacity to model and simulate potential hazards. In this context, embedding cyber security risks, and the complexity of cascading impacts in improving the understanding of disaster risks, calls for appropriate methods and tools allowing for a multi-risk and holistic focus to the assessment of risks and the planning of risk management capacities that follow.Research limitations/implicationsGlobally and in Europe, focus on interconnected risk and their impacts is steadily increasing. Risk assessments are still conservative; incorporation of cyber resilience into national and local level DRR plans is yet not visible.Originality/valueExisting research is restricted to cyber security and disaster resilience, as separated subjects. This paper, for the first time, brings together the interconnection between the two topic options to address them.