Qualification Guidelines Research Articles

Patient and public involvement in academic clinical research in Switzerland - a mixed methods study.

While patient and public involvement (PPI) in clinical research contributes substantially to research ethics, feasibility and quality, the uptake and implementation of PPI-based approaches in Switzerland remain unknown. This study aimed to evaluate the current state and acceptance of PPI in academic clinical research in Switzerland, with the goal of developing recommendations for its future implementation and development. A sequential explanatory mixed-methods study was conducted to assess the current landscape and acceptance of PPI in academic clinical research across different stakeholder groups in Switzerland. The groups were "Patients and Public", "Researchers", "Staff Members of Academic Research Infrastructure (ARI)" and representatives from "Regulatory and Funding Bodies". Data was collected through a combination of surveys and semi-structured interviews. The survey results were analysed descriptively, while interview data was analysed qualitatively. The results were further synthesised into a SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis. A total of 123 survey responses were collected.Surveys revealed great support and acceptance for PPI in academic clinical research in Switzerland across all stakeholder groups. Despite this support, several challenges were identified, including gaps in training, limited funding opportunities and insufficient infrastructure to facilitate PPI. The current framework for PPI in Switzerland is in an early stage of development. A joint effort by all stakeholders is needed to catch up with international progress to reach high-level ethical and quality standards. A basic framework for PPI in academic clinical research in Switzerland should be implemented, including guidelines for qualification and collaboration, best practices as well as widespread information for patients, the public and researchers. Further needed are training opportunities in "PPI in clinical research" for all stakeholders as well as sustainable sources of funding.

Effect of Nurse's detection of neurological deterioration on the prognosis of patients with acute cerebral infarction

IntroductionThere is little evidence about the factors related to the detection of neurological deterioration by nurses. We examined the related factors and therapeutic outcomes of nurses' detections of patient's neurological deterioration. MethodsThis was a descriptive retrospective study. We included 549 adult stroke patients who were admitted to the acute stroke unit of a tertiary hospital between May 2018 and December 2019 and had changes in neurological symptoms that were detected by stroke nurses. We measured the following outcomes: stroke lesion progression, early neurological deterioration (increase in the total national institutes of health stroke scale score of 2 points or more, increase in the limb weakness score of 1 point or more, or decrease in the alertness score of 1 point or more), and additional clinical management (increasing intravenous fluids, diagnostic imaging, or neuro-intervention). Data was analyzed by logistic regression. ResultsA total of 651 new or aggravating symptoms were detected by nurses. The most detected symptom was motor aggravations (49.2 %). Symptoms were commonly detected during the day shift (51.0 %) and by scheduled neurochecks (71.3 %). Of 132 patients who underwent diagnostic imaging by nurses’ detection, 63.6 % cases had stroke lesion progression. Nursing experience over 4 years was positively associated with finding stroke lesion progression (OR: 2.49, 95 % CI = 1.09–5.67). Early neurological deterioration was found in 70.7 %, and it was significantly higher during scheduled neurochecks (OR:2.65, 95 % CI = 1.04–6.72) and in the group of large artery atherosclerosis (OR: 2.19, 95 % CI = 1.06–4.49) Additional clinical management was provided to 49.9 % of detection, and scheduled neurocheks (OR: 4.76, 95 % CI = 2.18–10.39) and changes of alertness (OR: 2.89, 96 % CI = 1.51–5.26) were the significant factors. ConclusionStroke nurses were able to detect a large number of stroke lesion progression and early neurological deterioration as well as to provide additional clinical management. Systematic guidelines for qualification of stroke nurses may be beneficial.

Utilizing droplet digital polymerase chain reaction for siRNA quantitation in rodent plasma and tissue via stem-loop reverse transcription.

Background: siRNA is a promising therapeutic modality highlighted by several US FDA approvals since 2018, with many more oligonucleotide assetsin clinical development. To support siRNA discovery and development, robust and sensitive quantitative platforms for bioanalysis must be established to assess pharmacokinetic/pharmacodynamic relationships and toxicology. Droplet digital PCR offers improved sensitivity and throughput, as well as reduced susceptibility to matrix effects, compared with other analytical platforms. Methodology: The authors developed a stem-loop reverse transcription droplet digital PCR method to measure siRNA in mouse plasma and liver extract using bioanalytical method qualification guidelines. Conclusion: This newly developed assay has been demonstrated to be a superior alternative to other platforms, with the added benefit of greater sensitivity, with dynamic range from 390 to 400,000 copies/reaction and readiness for FDA investigational new drug-enabling applications.

Response to Letters to the Editor by Gregory J, Rice K, McCarthy K, et al. 2023 Regarding: "Guidelines for Qualifications of Neurodiagnostic Personnel: A Joint Position Statement of the American Clinical Neurophysiology Society, the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Society of Neurophysiological Monitoring, and ASET-The Neurodiagnostic Society".

Response to Letters to the Editor by Gregory J, Rice K, McCarthy K, et al. 2023 Regarding: "Guidelines for Qualifications of Neurodiagnostic Personnel: A Joint Position Statement of the American Clinical Neurophysiology Society, the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Society of Neurophysiological Monitoring, and ASET-The Neurodiagnostic Society".

Letter to the Editor Regarding: "Guidelines for Qualifications of Neurodiagnostic Personnel: A Joint Position Statement of the American Clinical Neurophysiology Society, the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Society of Neurophysiological Monitoring, and ASET-The Neurodiagnostic Society".

Letter to the Editor Regarding: "Guidelines for Qualifications of Neurodiagnostic Personnel: A Joint Position Statement of the American Clinical Neurophysiology Society, the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Society of Neurophysiological Monitoring, and ASET-The Neurodiagnostic Society".

Replacing Traditional Aseptic Process Simulations with Qualification of Cell and Gene Therapy (CGT) Supernatant.

Aseptic process simulations (APS) are traditionally performed using Tryptic Soy Broth (TSB) as a surrogate for finished product to qualify aseptic manufacturing operations. In this study, the supernatant from cell processing media was examined for bacterial and fungal growth viability to determine equivalency with TSB. With the use of cell processing media in Cell and Gene Therapy (CGT) manufacturing, can qualifying the supernatant collected from the process eliminate the need for an APS run?Supernatant was collected from cell processing media and incubated at same incubations conditions required for the APS post sterility check (Test A - 7d 20-25°C/7d 30-35°C) and at use conditions (Test B - 14 d at 35°C/5%CO/5%O2). Post incubation, growth promotion testing was performed using ATCC cultures (Ab+, Bs+, Ca+, Ec+, Sa+, Pa+ and Se+), which resulted in growth for Tests A-B and the positive inoculum control. Results concluded that the cell processing supernatant examined was equivalent to TSB, thereby implying that each cell therapy manufacturing run is aseptically self-validating. As more practical approaches emerge for APS qualifications in CGT manufacturing, this data can be used to implement alternate options to qualify a CGT manufacturing process and help establish guidelines for future cell therapy APS qualifications.

Response to a Letter to the Editor by Gregory et al. Regarding: “Guidelines for Qualifications of Neurodiagnostic Personnel: A Joint Position Statement of the American Clinical Neurophysiology Society, the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Society of Neurophysiological Monitoring, and ASET – The Neurodiagnostic Society”

Response to a Letter to the Editor by Gregory et al. Regarding: “Guidelines for Qualifications of Neurodiagnostic Personnel: A Joint Position Statement of the American Clinical Neurophysiology Society, the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Society of Neurophysiological Monitoring, and ASET – The Neurodiagnostic Society”

Penerapan Model Pembelajaran Discovery Learning untuk Meningkatkan Pemahaman Konsep Matematis

The purpose of this study was to improve students' understanding of mathematical concepts on the competence of rational and irrational inequalities through the application of the discovery learning model. The research method used is quantitative method with discovery learning approach, the subject of this research is X TKJ class students of SMK Negeri 1 Tuhemberua. This research took place in two cycles, namely cycle I consisting of 3 meetings and cycle II consisting of 3 meetings. Data collection techniques in this study were observation and objective tests. The instruments used were observation sheets and objective test questions. Based on the results of the study, it was found that the implementation of mathematics learning with the application of the discovery learning model can improve the understanding of mathematical concepts of class X TKJ students of SMK Negeri 1 Tuhemberua on the competence of rational and irrational inequality of one variable. This is based on data obtained through the results of cycle I tests and cycle II tests, the average percentage of students' understanding of mathematical concepts has increased by 15.67%, namely in cycle I of 66.28% and increased to 77.81% in cycle II. The conclusion in this study is that the average percentage of students' understanding of mathematical concepts has increased in cycle I and increased again in cycle II. Based on the qualification guidelines in the percentage table presented in the discussion section, it is classified in the high category.
 
 Keywords: discovery learning model, concept comprehension, high school mathematic

Guidelines for Qualifications of Neurodiagnostic Personnel: A Joint Position Statement of the American Clinical Neurophysiology Society, the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Society of Neurophysiological Monitoring, and ASET The Neurodiagnostic Society.

The Guidelines for Qualifications of Neurodiagnostic Personnel (QNP) document has been created through the collaboration of the American Clinical Neurophysiology Society (ACNS), the American Society of Neurophysiological Monitoring (ASNM), the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM), and ASET The Neurodiagnostic Society (ASET). The quality of patient care is optimized when neurophysiological procedures are performed and interpreted by appropriately trained and qualified practitioners at every level. These societies recognize that neurodiagnostics is a large field with practitioners who have entered the field through a variety of training paths. This document suggests job titles, associated job responsibilities, and the recommended levels of education, certification, experience, and ongoing education appropriate for each job. This is important because of the growth and development of standardized training programs, board certifications, and continuing education in recent years. This document matches training, education, and credentials to the various tasks required for performing and interpreting neurodiagnostic procedures. This document does not intend to restrict the practice of those already working in neurodiagnostics. It represents recommendations of these societies with the understanding that federal, state, and local regulations, as well as individual hospital bylaws, supersede these recommendations. Because neurodiagnostics is a growing and dynamic field, the authors fully intend this document to change over time.

Paul and Church Leadership: Towards an African Transformational Interpretation of Titus1:1-9 for the Rwandese Church

The scripture text from Titus 1:1-9 is a model that provides guidelines for selection and qualification of leaders in church administration. The purpose of this paper is to investigate leadership based on the scripture according to Titus through the lens of an African transformational interpretation and in light of the Rwandan church leadership. The evidence that challenges the leadership of the church in Rwanda can be drawn back from the 1994 genocide attack committed against Tutsis where some church leaders were unable to resist the tragedy while others participated in it. This is contrary to Titus 1:1-9 vis –a- vis the qualities of a leader. Through the African transformational interpretation applied to Titus 1:1-9, Rwandan church leadership must select and appoint leaders without reproach who can make an influential move using the similar core Christian characters shown in the scripture. This can serve as an apostolic manual for building a church that will survive in whatever circumstances that portrays the glory of God.

Guidelines for Qualifications of Neurodiagnostic Personnel: A Joint Position Statement of the American Clinical Neurophysiology Society, the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Society of Neurophysiological Monitoring, and ASET-The Neurodiagnostic Society.

The Guidelines for Qualifications of Neurodiagnostic Personnel (QNP) document has been created through the collaboration of the American Clinical Neurophysiology Society (ACNS), the American Society of Neurophysiological Monitoring (ASNM), the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM), and ASET-The Neurodiagnostic Society (ASET). The quality of patient care is optimized when neurophysiological procedures are performed and interpreted by appropriately trained and qualified practitioners at every level. These societies recognize that neurodiagnostics is a large field with practitioners who have entered the field through a variety of training paths. This document suggests job titles, associated job responsibilities, and the recommended levels of education, certification, experience, and ongoing education appropriate for each job. This is important because of the growth and development of standardized training programs, board certifications, and continuing education in recent years. This document matches training, education, and credentials to the various tasks required for performing and interpreting neurodiagnostic procedures. This document does not intend to restrict the practice of those already working in neurodiagnostics. It represents recommendations of these societies with the understanding that federal, state, and local regulations, as well as individual hospital bylaws, supersede these recommendations. Because neurodiagnostics is a growing and dynamic field, the authors fully intend this document to change over time.

Guidelines for Qualifications of Neurodiagnostic Personnel: A Joint Position Statement of the American Clinical Neurophysiology Society, the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Society of Neurophysiological Monitoring, and ASET – The Neurodiagnostic Society

ABSTRACT The Guidelines for Qualifications of Neurodiagnostic Personnel (QNP) document has been created through the collaboration of the American Clinical Neurophysiology Society (ACNS), the American Society of Neurophysiological Monitoring (ASNM), the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM), and ASET – The Neurodiagnostic Society (ASET). The quality of patient care is optimized when neurophysiological procedures are performed and interpreted by appropriately trained and qualified practitioners at every level. These Societies recognize that Neurodiagnostics is a large field with practitioners who have entered the field through a variety of training paths. This document suggests job titles, associated job responsibilities, and the recommended levels of education, certification, experience, and ongoing education appropriate for each job. This is important because of the growth and development of standardized training programs, board certifications, and continuing education in recent years. This document matches training, education, and credentials to the various tasks required for performing and interpreting Neurodiagnostic procedures. This document does not intend to restrict the practice of those already working in Neurodiagnostics. It represents recommendations of these Societies with the understanding that federal, state, and local regulations, as well as individual hospital bylaws, supersede these recommendations. As Neurodiagnostics is a growing and dynamic field, we fully intend this document to change over time.

Qualitative Analysis of the Content Validity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Schizophrenia: A Multi-Stakeholder Perspective.

The US Food and Drug Agency (FDA) requires clinical trials targeting cognitive impairment associated with schizophrenia (CIAS) to demonstrate the functional relevance of cognitive improvements by employing a functional co-primary measure. Although quantitative evidence supports the suitability of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) for this purpose, FDA guidelines for qualification of clinical outcome assessments require evidence of content validity, defined as qualitative evidence that key stakeholders view the measure as relevant and important. To collect this important qualitative data, semi-structured interviews were conducted with outpatients with schizophrenia (n = 24), caregivers (n = 12), and professional peer support specialists (n = 12) to elicit their views about the definition and importance of functional independence, the importance of the functional domains assessed by the VRFCAT (meal planning, using transportation, handling money, shopping), and the relevance of the VRFCAT tasks to these domains. Qualitative thematic analyses revealed consistent themes across groups in defining functional independence, including performing instrumental self-care, financial, and social tasks; making decisions autonomously; and not depending on others to carry out daily activities. There were, however, notable differences in their views regarding the importance of and barriers to functional independence. All groups viewed the VRFCAT as assessing skill domains that are central to independent functioning and, with some minor differences, the VRFCAT tasks were viewed as relevant and meaningful examples of the domains. These qualitative results provide converging evidence that key stakeholders view the VRFCAT as a content-valid measure.

Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology

BackgroundConventional preclinical models often miss drug toxicities, meaning the harm these drugs pose to humans is only realized in clinical trials or when they make it to market. This has caused the pharmaceutical industry to waste considerable time and resources developing drugs destined to fail. Organ-on-a-Chip technology has the potential to improve success in drug development pipelines, as it can recapitulate organ-level pathophysiology and clinical responses; however, systematic and quantitative evaluations of Organ-Chips’ predictive value have not yet been reported.Methods870 Liver-Chips were analyzed to determine their ability to predict drug-induced liver injury caused by small molecules identified as benchmarks by the Innovation and Quality consortium, who has published guidelines defining criteria for qualifying preclinical models. An economic analysis was also performed to measure the value Liver-Chips could offer if they were broadly adopted in supporting toxicity-related decisions as part of preclinical development workflows.ResultsHere, we show that the Liver-Chip met the qualification guidelines across a blinded set of 27 known hepatotoxic and non-toxic drugs with a sensitivity of 87% and a specificity of 100%. We also show that this level of performance could generate over $3 billion annually for the pharmaceutical industry through increased small-molecule R&D productivity.ConclusionsThe results of this study show how incorporating predictive Organ-Chips into drug development workflows could substantially improve drug discovery and development, allowing manufacturers to bring safer, more effective medicines to market in less time and at lower costs.

Influence of part geometry on spatter formation in laser powder bed fusion of Inconel 718 alloy revealed by optical tomography

The metal powder used during the Laser Powder Bed Fusion (L-PBF) process is usually cycled for reuse in subsequent build jobs for cost-effectiveness and sustainability. Qualification guidelines are being established based on testing results of powder properties in terms of flowability, chemistry and rheological behaviors, etc. for making decisions on whether a batch of reused powder is suitable for producing parts that meet certain requirements. The current paper aims to develop experimental strategies for tracking powder history using novel design of specimens and on-line monitoring. Powder-capturing containers designed with internal lattice structures of varied beam lengths and diameters were manufactured by the L-PBF process using an Inconel 718 powder to investigate the influence of part geometry on the degradation of reused powder. The L-PBF experiment was monitored by a commercial Optical Tomography (OT) system which records the thermal emissions from the build area. Data were extracted from the OT images to evaluate the emissions of spatter particles introduced to the powder bed, which is influenced by the local layer profiles of the lattices and the overall geometries of the container. The collected powder samples were tested by combustion analysis for oxygen content and characterized by Scanning Electron Microscopy (SEM). Surface chemistry analyses of the powders were performed by X-ray Photoelectron Spectroscopy (XPS). Depending on the lattice structure geometry, the oxygen uptake in the powder collected from the containers was increasing by 10 ppm in case of empty container and up to as high as 118 ppm in case of container with larger areas of overhangs and higher surface-to-volume ratio. XPS results revealed the presences of Al-rich and Cr-rich oxides on the surface of powder samples collected from the container filled with lattices of high surface-to-volume ratio and the container filled with lattices of large overhangs, which agrees with the analyses of OT data.

Ptosis – diagnostics and treatment

It is estimated that the low position of the upper eyelid affects over 1 million patients in Poland. Ptosis limits the visual field, causes compensatory head positions and the feeling of visual deterioration. The unaesthetic appearance of the eyes additionally contributes to low self-esteem. The aim of this article is to review modern diagnostic algorithms used in the case of a dropped eyelid. The paper also discusses the surgical techniques that are used in the case of ptosis and the guidelines for the correct qualification of the patient to a given surgical method.

Guidance on qualifications for fertility counselors: a committee opinion

This guidance document was developed by the Mental Health Professional Group (MHPG) in partnership with the Practice Committee of the American Society for Reproductive Medicine (ASRM) to help determine the qualifications and training of mental health professionals working in reproductive medicine. This document replaces the document titled "ASRM Qualification Guidelines for Infertility," last published in March 2015 and originally developed in1995.

Powders for Additive Manufacturing: From Design to Certification

Rina Consulting Centro Sviluppo Materiali (CSM) has been involved in the study and development of powder metallurgy for different applications, thanks to its participation in many research industrial and funded projects. The entire metal powder production chain takes place within the company's own researcher and facilities. This allows to produce high quality powders starting from alloy design, VIGA atomization and chemical, rheological and particle size analysis. In recent years, the development has mainly concerned manufacturing processes. Currently only a limited number of metal alloys can be processed by AM. For that reason, the alloy design becomes a really important topic to enlarge AM capabilities to other materials and applications. Starting from commercial Thermodynamic and Kinetic codes and proprietary models on solidification and micro-segregation, the alloy chemical composition can be fine-tuned to optimize the microstructure, considering the target properties of the material and the relevant AM processing windows, taking into account also the post process treatment conditions. Moreover, the knowledge of the production plants allows CSM to have a wide vision on the realization and the characterization of the metal powders focusing to achieve the best powder quality suitable for AM applications. Finally, AM is a relatively “new” process, standardization is still an ongoing activity involving several communities and organizations like ASTM, AWS and ISO; in this contest CSM has already designed the guidelines for qualification and certification processes and has created a dedicated laboratory to qualify powders of AM players.

Latest developments in adhesive anchoring technology

Adhesive anchoring is used to connect steel and concrete elements and to connect new to existing reinforced concrete structures. For this, threaded rods or reinforcing bars are bonded to the hardened concrete by adhesives. Internationally recognized qualification guidelines and design codes form the regulative basis for all approved products and ensures a high level of safety. This paper introduces the context of adhesive anchoring systems. An overview of relevant international regulations is provided, and the difference between post-installed anchor and post-installed rebar applications is explained. The latest developments in adhesive anchoring in regard to qualification and design is presented. The contribution aims at bringing the adhesive anchoring technology to the attention of a broader audience of the engineering and research community.

Structural integrity of liner cement in oil & gas wells: Parametric study, sensitivity analysis, and risk assessment

Cement is an important barrier element that provides pressure isolation between formation(s) and a well. Failure in the cement sheath can compromise well integrity and potentially lead to severe environmental, health, safety, and business impacts.This work aims to assess fitness-for-service of cement sheath specifically in the context of shallow depth liner-casing overlaps in offshore wells. Primary objective of this paper is to investigate influence of pressure loads, material properties, and sheath dimensions on structural integrity of cement. The ultimate objective is to perform risk assessment and identify likely modes of failure. This work is based on a three-dimensional finite element model of cement sheath validated by analytical calculations. Sensitivity analysis was performed to evaluate and rank the influence of various operating and design parameters on mechanical stresses in a cement sheath.Results indicate that cement material properties (Young’s modulus, Poisson’s ratio, expansion) and wellbore pressure are the major factors influencing cement’s structural integrity. Risk assessment suggests that interfacial bond failure, radial cracking, and cement top failure are likely modes of structural failure for a cement sheath in shallow-depth liner-casing overlap. Flexible and expanding cement are likely to be more robust to structural failure than brittle and non-expanding cement. Although annulus pressure has negligible influence on stress distribution within bulk of a cement sheath, it can potentially cause failure near the top of the cement column.Sensitivity curves generated in this work will help engineers understand performance of cement sheath under different conditions. Regulators and industry will be able to strengthen the guidelines for assessment and qualification of cement as a barrier.