Guidance Document Research Articles

Microbial biopesticides are inhibited by honey bee royal jelly and in vitro larval diet

The interest in and use of biological materials in crop production is increasing globally at a rapid pace. In many cases, testing methods for conventional chemicals are applied to microbial-based biopesticides because specific microbial test methods are lacking. However, not all methods are easily transferred to microbial-based products. An evaluation was conducted to determine if OECD (Organization for Economic Co-operation and Development) Guidance Document No. 239 on honey bee larval toxicity could be adapted to microbial pesticides. In our study, five microbes, including B. pumilus, B. thuringiensis, B. velezensis, Paenibacillus larvae, and Ascophaera apis were grown on agar media and spotted with either honey bee in vitro larval diet or royal jelly. We observed that the honey bee larval bee diet and royal jelly did not inhibit the fungal honey bee pathogen Ascophaera apis, yet inhibited the growth of bacteria, including a known honey bee larval pathogen. This finding may make the test unreliable for certain biopesticides. The OECD is considering biopesticide-specific testing guidelines, and the EPA has indicated it to update itsbiopesticide bee test guidelines. However, additional research is needed to determine which options may be feasible and provide the best improvements.

A 2024 inventory of test methods relevant to thyroid hormone system disruption for human health and environmental regulatory hazard assessment

Thyroid hormone system disruption (THSD) is a growing concern in chemical hazard assessment due to its impact on human and environmental health and the scarce methods available for assessing the THSD potential of chemicals. In particular, the general lack of validated in silico and in vitro methods for assessing THS activity is of high concern. This manuscript provides an inventory of test methods relevant to THSD. Building on the Organisation for Economic Co-operation and Development (OECD) Guidance Document 150 and recent international developments, we highlight progress in in silico and in vitro methods, as well as in vivo assays. The provided inventory categorizes available methods according to the levels of the OECD Conceptual Framework, with an assessment of the validation status of each method. At Level 1, 12 in silico models that have been statistically validated and are directly related to THSD have been identified. At Level 2, 67 in vitro methods have been listed including those assessed in key initiatives such as the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) validation study to identify potential thyroid disruptors. At Levels 3-5, THSD-sensitive endpoints are being included in existing fish-based OECD Test Guidelines to complement amphibian assays. In total, the inventory counts 108 entries comprising established methods (e.g., OECD Test Guidelines) as well as citable methods that are under further development and in some cases are ready for validation or in the initial stages of validation. This work aims to support the ongoing development of strategies for regulatory hazard assessment, such as integrated approaches to testing and assessment (IATAs), for endocrine disruptors, addressing critical gaps in the current testing landscape for THSD in both human and environmental health contexts.

Pelaksanaan Layanan Administrasi Kesiswaan di MAN 2 Palembang

This research is titled "Implementation of Student Administrative Services at MAN 2 Palembang." The aim of this study is to analyze how the implementation of student administrative services is carried out at MAN 2 Palembang. This research is a field study, employing a qualitative descriptive approach. Data collection techniques include observation, interviews, and documentation. Data analysis techniques consist of data reduction, data presentation, data verification, and drawing conclusions. The validity of the research data is ensured through source triangulation and technique triangulation. The results of the study indicate that the implementation of student administrative services at MAN 2 Palembang is well underway. The research findings demonstrate that student administrative services at MAN 2 Palembang are effectively executed, encompassing aspects such as effective guidance in the admission of new students, student discipline regulation, guidance and counseling documentation, as well as student learning progress recording. Effective guidance assists students in understanding the process of new student admission clearly, ensuring their comprehension without difficulty, setting clear objectives, and planning strategies to achieve them. Student discipline regulations ensure discipline and responsibility among students, while guidance and counseling documentation provide appropriate guidance and support. Recording student learning progress serves to provide a comprehensive overview of student development and aid them in their educational journey at MAN 2 Palembang.

Improving communication between volcano observatories and volcanic ash advisory centres in Europe—outcomes from a first workshop

AbstractEffective aviation response to atmospheric emissions from volcanic eruptions relies upon timely communication and information exchange. To explore the current and best practices in this area, a workshop was held in February 2019 under the framework of the European H2020 EUROVOLC project (2018–2021). The objective of the workshop was to bring together the volcano observatories (VOs), volcanic ash advisory centres (VAACs), and volcanological research institutes in Europe. The workshop included scientists and operational staff from six of Europe’s VOs (Iceland, Italy, France, Spain, Portugal, and Greece), the London and Toulouse VAACs, and seven supporting institutions and organisations. During the workshop, participants identified future improvements to the way the VOs and VAACs communicate and share information. Recommendations include refining the guidance and local documentation on the correct use of the Volcano Observatory Notice for Aviation (VONA), improving the two-way feedback between the VAAC and VOs, regular sharing of volcano status updates by the VO, and inclusion of all VOs in regular VAAC and aviation exercises. These are applicable to VOs and VAACs elsewhere in the world.

Evaluating progress towards implementation of the European HTA Regulation: Insights generated from the European Access Academy's multi-stakeholder survey

ObjectivesWe conducted a multi-stakeholder survey to assess stakeholders' perceptions of the progress made towards the implementation of the European Regulation on Health Technology Assessment (EU HTA R) and to identify and prioritize the remaining challenges for implementation. MethodsUsing two iterative Delphi cycles, an exploratory, semi-quantitative survey was developed to identify how stakeholders 1) experienced preparatory activities of the Regulation, and 2) prioritized remaining challenges for successful implementation. The survey was distributed among the network of the European Access Academy and via social media to ensure coverage of key stakeholders. Descriptive analyses were performed on quantitative response items, and relative importance was calculated for ranking items. Free-text responses supplemented participants' answers to quantitative questions. ResultsN = 61 responses were received from N = 15 countries including Global/ EU-wide institutions (Patients and Patients’ representatives: 7; Clinicians’ representatives: 5; Regulators: 3; Health Technology Developers (HTDs): 20; HTA bodies: 10; Payers: 7; Policy Makers: 2; Academic representatives: 7). The majority of respondents were aware of preparatory activities, with 74 % (N = 45) observing the drafting of Guidance Documents and 64 % (N = 39) noting the establishment of the Coordination Group. Respondents ranked the success of preparatory activities neutral with a slight tendency towards a positive ranking. Key challenges were Member States' readiness for Joint Clinical Assessments, HTA capacity/ capability constraints, and the applicability/ feasibility of the methodological framework. ConclusionsThis study identified the key remaining challenges for the successful establishment of the EU HTA process. Key findings emphasize the readiness of national systems and procedures as pivotal factors. Balancing operational efficiency with strategic objectives, including the development of a European Value Framework, is imperative for harnessing the full potential of the joint HTA process and enhancing patient access to innovative technologies on a pan-European scale. Public interest summaryIn January 2022, the European Union (EU) adopted the European Regulation on Health Technology Assessment (HTA). By harmonizing HTA practices and promoting collaboration across Member States, the joint procedure as set out in the regulation aims to improve efficient use of resources and ensure long-term sustainability of EU-wide HTA cooperation. Close to reaching the half-way mark of the preparation phase in mid-2023, we conducted a multi-stakeholder survey to assess perceptions of the progress made towards implementation of a joint procedure and to prioritize remaining challenges. The responses indicated a neutral to positive perception of the preparatory activities (i.e., establishing a coordination group and a stakeholder network, and creating guidance documents). Respondents prioritized challenges related to the readiness of Member States, limitations in HTA capacity and capability, and applicability of the assessment methods. Further research is needed to define targeted strategies for specific stakeholder groups to effectively address the identified challenges.

FORMAL AND NON-FORMAL EDUCATION IN SPACES OF RESTRICTION OF FREEDOM: A BRIEF ANALYSIS OF THE STATE OF SÃO PAULO

This article aims to analyze the structure and organization of formal and non-formal education in prisons in the state of São Paulo, identifying how education is systematized and implemented within the prison system. The methodology included the review of official documents and data, such as the Penal Information Report (RELIPEN) and the Joint Guidance Documents of the Secretariats of Education and Penitentiary Administration. The results indicate that, although the state of São Paulo continues to invest significantly in the prison system, the lack of information on available resources and persistent overcrowding indicate critical challenges for the effective implementation of educational activities.

Effectiveness of The Early Start Denver Model for Children with Autism: A Narrative Review and Experiences for Viet Nam

Early intervention for children with autism is crucial for their development and quality of life. Different early intervention models exist, including the Early Start Denver Model, which has scientific evidence and is included in Vietnam's Guidance Document on Diagnosis and Intervention for Children with autism spectrum disorders. Therefore, quantitative research design and descriptive statistics methodologies are used in the study to review the Denver early intervention model's effectiveness in treating children with autism worldwide and bring lessons learned for application in Vietnam. This narrative review analyses 16 scientific articles conducted in an international database. Research results show that the Early Start Denver Model is efficacious in improving core defects in children with autism, such as social skills, communication skills, and repetitive behaviors,…; using the Early Start Denver Model will improve parent-child interactions, reducing stress for parents during the parenting process. The findings also indicate lessons for applying the Early Start Denver Model for children with autism in Vietnam, considering factors like regional culture, educational facilities, and learning materials; motor skills and imitation skills should be combined with other therapies for better effectiveness.

ADLM Guidance Document on the Measurement and Reporting of Lipids and Lipoproteins.

The accurate measurement of blood lipids and lipoproteins is crucial for the clinical management of atherosclerotic disease risk. Despite progress in standardization, there are still significant variations in pre-analytical requirements, methods, nomenclature, and reporting work flows. The guidance document aims to improve standardization of clinical lipid testing work flows. It provides recommendations for the components of the lipid panel, fasting requirements, reporting of results, and specific recommendations for non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), lipoprotein(a) [Lp(a)], apolipoprotein B (apo B), point-of-care lipid testing, and LDL subfraction testing. Lipid panels should always report non-HDL-C and LDL-C calculations if possible. Fasting is not routinely required except in specific cases. Modern equations should be utilized for LDL-C calculation. These equations allow for LDL-C reporting at elevated concentrations of triglycerides and obviate the need for direct measured LDL-C in most cases.

Round Robin Study for Evaluation an in vitro skin irritation test for medical device extracts using KeraSkinTM in Korea

With the growing importance of alternative test methods that implement the 3Rs principles (Reduction, Refinement and Replacement) and the global importance of biological safety assessment data for medical devices is increasing. We have developed and optimized the ‘KeraSkin™ Skin Irritation Test (KeraSkin™ SIT) for medical device’ for regulatory application in biological evaluation according to ISO 10993-23. We conducted a round robin study to optimize and evaluate the performance of KeraSkin™ SIT for medical devices using KeraSkin™ Reconstructed Human Epidermis (RhE), which is developed and manufactured in Korea. This round robin study was performed to assess the transferability, reproducibility (within and between laboratories) and predictive capacity in 1 lead laboratory and 3 participating laboratories based on OECD Guidance Document 34. The predictive capacity, the results showed 83.3 % of sensitivity, 100 % of specificity and 91.6 % of accuracy. In conclusion, the results demonstrate that ‘KeraSkin™ SIT for medical device’ provides a robust test method for detecting irritant activity of medical device extracts and can be utilized for identifying low levels of potent irritants in medical device extracts. Therefore, it fulfills the requirements to be included as a ‘me-too’ test method to EpiDerm™ and SkinEthic™ skin irritation test in ISO 10993-23.

Examining Delineated Competencies within Blended Hospital/Health System Pharmacy and General Medicine Advanced Pharmacy Practice Experiences.

In the United States, Doctor of Pharmacy (PharmD) programs are required to provide advanced pharmacy practice experiences (APPEs) in the core inpatient rotation areas of hospital/health system pharmacy and inpatient general medicine patient care. Colleges and Schools of Pharmacy (C/SOPs) nationwide are increasingly utilizing blended or longitudinal APPE models to offer experiential opportunities; however, there is a gap in the literature to support programs with delineating rotation-specific competencies when integrating two or more rotations together. Utilizing a survey instrument, PharmD students at two C/SOPs reported their onsite inpatient rotation sub-competency activities achieved within the four competency areas of Hospital/Health Pharmacy Systems, Medication Safety and Quality, Clinical Applications, and Professional Practice, which are listed in Appendix C of the 2016 Accreditation Council for Pharmacy Education Standards Guidance Document. Unpaired two-sample t-tests were performed to compare proportions of sub-competency activity occurrence in the two rotation settings. In total, 168 students reported inpatient activities related to the four competency areas, with 95-100% reporting their involvement in one or more sub-competency opportunities within each area. Of the 26 sub-competencies compared, 73% significantly facilitated the development of competency to a greater extent for one APPE inpatient rotation type over the other (p < 0.05). The findings can be utilized by C/SOPs to support the delineation of rotation-specific competencies when blending inpatient experiential opportunities.

Implementation of CYP2C19 and CYP2D6 genotyping to guide antidepressant use in a large rural health system.

We describe the implementation and ongoing maintenance of CYP2C19 and CYP2D6 focused pharmacogenetic (PGx) testing to guide antidepressant and antianxiety medication prescriptions in a large rural, nonprofit health system. Depression and anxiety are common psychiatric conditions. Sanford Health implemented PGx testing for metabolism of cytochrome P450 (CYP) isozymes 2C19 and 2D6 in 2014 to inform prescribing for multiple medications, including antidepressant and antianxiety therapies. As guidelines, genotype to phenotype translation, panel offerings, and other resources are updated, we adapt our approach. We make educational and informational materials available to providers and patients. Pharmacogenomic clinical pharmacists review PGx results with discrete values and provide guidance documentation in the electronic medical record. A robust clinical decision support system is in place to provide interruptive alerts, noninterruptive alerts, and genomic indicators. A referral-based interdisciplinary clinic is also available to provide in-depth education to patients regarding PGx results and implications. Additionally, partnering with our health plan has expanded access to PGx testing for patients with anxiety or depression. The implementation and maintenance of Sanford Health's PGx program to guide antidepressant and antianxiety medication use continues to evolve and requires a multipronged approach relying on both human and informatics-based resources.

Team talk and the evaluation of medical guidance documentation

This article looks at team talk in a validation committee meeting assessment of a guidance document text item. The item assessment was not evidence-based in terms of Evidence Based Medicine (EBM) criteria; instead, the item was assessed via the committee members present drawing on their clinical practitioner members’ knowledge and professional experience. Analysis of the meeting reveals such apparently ‘mere opinion’ to be a systematic evaluation of professional knowledge and personal experiences, in ways ‘compatible’ with thought experiments. Thought experiments are argued to be a members’ resource as well as an analyst’s one, although their detailed occasionedness is not reducible to a constructivist formalisation. The article’s approach is informed by ethnomethodology and conversation analysis, and while the use of thought experiments as a heuristic device in the analysis is controversial, a warrant for this is attempted. The research was undertaken to locate ways of understanding and supporting team members’ work of robust and useful guidance content production. ‘Validating’ guidance is shown in-and-as the emergent collaborative work of the committee members themselves.

CSP2023: 225 - Development of a Physiotherapy in Eating Disorders Guidance Document

CSP2023: 225 - Development of a Physiotherapy in Eating Disorders Guidance Document

The Ethical Principles in Ethical Guidance Documents during the COVID-19 Pandemic in the United Kingdom and the Republic of Ireland: A Qualitative Systematic Review.

The sudden onset of the coronavirus disease 2019 (COVID-19) pandemic was accompanied by a myriad of ethical issues that prompted the issuing of various ethical guidance documents for health care professionals in clinical, research, and public health settings throughout the United Kingdom (UK) of Great Britain and Northern Ireland and the Republic of Ireland. The aim of this review was to identify the main principles in ethical guidance documents published in the UK and Ireland during the COVID-19 pandemic. This review used a qualitative systematic review methodology with thematic synthesis to analyze the included ethics-related guidance documents, as defined in this review, published in the UK and Ireland from March 2020 through March 2022. The search included a general search in Google Scholar and a targeted search on the websites of the relevant professional bodies and public health authorities in the two countries. The ethical principles in these documents were analyzed using the constant comparative method (CCM). Forty-four guidance documents met the inclusion and exclusion criteria. Ten main ethical principles were identified, namely: fairness, honesty, minimizing harm, proportionality, responsibility, autonomy, respect, informed decision making, duty of care, and reciprocity. The guidelines did not present the ethical principles in equal detail. Some principles lacked definitions, leaving them vulnerable to misinterpretation by the documents' end users. Priority was frequently given to collectivist ethics over individualistic approaches. Further clarity is required in future ethical guidance documents to better guide health care professionals in similar situations.

ADLM Guidance Document on Laboratory Diagnosis of Respiratory Viruses.

Respiratory viral infections are among the most frequent infections experienced worldwide. The COVID-19 pandemic has highlighted the need for testing and currently several tests are available for the detection of a wide range of viruses. These tests vary widely in terms of the number of viral pathogens included, viral markers targeted, regulatory status, and turnaround time to results, as well as their analytical and clinical performance. Given these many variables, selection and interpretation of testing requires thoughtful consideration. The current guidance document is the authors' expert opinion based on the preponderance of available evidence to address key questions related to best practices for laboratory diagnosis of respiratory viral infections including who to test, when to test, and what tests to use. An algorithm is proposed to help laboratories decide on the most appropriate tests to use for the diagnosis of respiratory viral infections.

ANALISIS KINERJA GURU BK: PELAKSANAAN BIMBINGAN KLASIKAL DI SEKOLAH MENENGAH KEJURUAN

This study aims to look at the performance of guidance and counseling teachers at SMKN 1 Cikarang Utara in the 2023/2024 academic year. This research uses a type of qualitative research with a case study design with a focus on developing an in-depth analysis of the performance of guidance and counseling teachers. Data collection techniques using observation of the environment of SMKN 1 Cikarang Utara, interviews with the head of bk coordination and 3 guidance and counseling teachers and documentation in the form of photos and collection of supporting data. Data validity techniques use validity and credibility tests by triangulation as reinforcement and supporting data. The results showed that the implementation of the classical guidance program carried out went well in accordance with the objectives to be achieved. There is a change for the better in achieving service goals before and after being given a classical guidance program. These changes were accepted by several students. Changes that occur include changes in behavior, mindset, insight and knowledge.

A Sensitivity Study for Interpreting Nucleic Acid Sequence Screening Regulatory and Guidance Documentation: Toward a Foundational Synthetic Nucleic Acid Sequence Screening Framework.

The primary objectives of this study were to develop an objective nucleic acid sequence screening framework and to leverage the framework for an empirical sensitivity study that measures the impact of ambiguities in regulatory and guidance documentation regarding the control of synthetic nucleic acids and screening of nucleic acid orders. Foundational risk levels were constructed using the bioinformatic sequencing screening tool UltraSEQ. The risk levels range from high (corresponding to regulated sequences) to low (corresponding to nonregulated sequences of concern) to no-risk. A representative sequence data set (141,651 sequences) was constructed from publicly available synthetically derived sequences, and the percentage sequences in each risk level was determined, followed by the impact of changing key UltraSEQ parameters. The results of this study show that no-risk sequences represent 90-92% of sequences, and nonregulated sequences of concern represented 7-9% of the sequences regardless of the parameters. The parameter with the biggest impact on the number of sequences flagged was the minimum hit homology level, followed by minimum sequence region length, and finally uniqueness of the hit to a select agent sequence. The results of this empirical study provide a greater understanding for gene synthesis providers, biosafety and biosecurity practitioners, and the scientific community regarding the impact of various interpretations of regulatory and guidance documentation. The risk level framework provides a foundation to build upon for nucleic acid sequence screening as the threat landscape evolves. However, additional development is needed to build tools that connect predictions across sequences and orders to provide contextual risk-based predictions.

Understanding three approaches to reporting sudden unexpected infant death in the USA

IntroductionIn the USA each year, there are approximately 3400 sudden unexpected infant (<1 year of age) deaths (SUID) which occur without an obvious cause before an investigation. SUID includes the...

Science-based Targets for Faith: Technical Guidance Document

This guide aims to provide a global standard for Faith-based Organizations (FBOs) to measure, manage, and report their greenhouse gas (GHG) emissions in alignment with the Paris Climate Agreement, and to advance FBOs as prominent environmental leaders that operate their physical assets in a climate positive manner.

Can Short-Term Online-Monitoring Improve the Current WFD Water Quality Assessment Regime? Systematic Resampling of High-Resolution Data from Four Saxon Catchments

The European Union Water Framework Directive (2000/60/EC; WFD) aims to achieve a good ecological and chemical status of all bodies of surface water by 2027. The development of integrated guidance on surface water chemical monitoring (e.g., WFD Guidance Document No. 7/19) has been transferred into national German law (Ordinance for the Protection of Surface Waters, OGewV). For the majority of compounds, this act requires monthly sampling to assess the chemical quality status of a body of surface water. To evaluate the representativeness of the sampling strategy under the OGewV, high-frequency online monitoring data are investigated under different sampling scenarios and compared with current, monthly grab sampling data. About 23 million data points were analyzed for this study. Three chemical parameters (dissolved oxygen, nitrate-nitrogen, and chloride concentration) and discharge data were selected from four catchments of different sizes, ranging from 51,391 km2 to 84 km2 (Elbe, Vereinigte Mulde, Neiße and two stations at Lockwitzbach). In this paper, we propose short-term online-monitoring (STOM) as a sampling alternative. STOM considers the placement of online sensors over a limited duration and return interval. In general, we: (I) compare the results of conventional grab sampling with STOM, (II) investigate the different performance of STOM and grab sampling using discharge data as a proxy for analyzing event-mobilized pollutants, and (III) investigate the related uncertainties and costs of both sampling methods. Results show that STOM outperforms grab sampling for parameters where minimum/maximum concentrations are required by law, as the probability of catching a single extreme value is higher with STOM. Furthermore, parameters showing a pronounced diurnal pattern, such as dissolved oxygen, are also captured considerably better. The performance of STOM showed no substantial improvements for parameters with small concentration variability, such as nitrogen-nitrate or chloride. The analysis of discharge events as a proxy parameter for event-mobilized pollutants proves that the probability of capturing samples during events is significantly increased by STOM.