Feasibility Assessment Research Articles

Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations.

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) launched a strategy to examine the public health impact of major regulatory interventions aimed at minimising risks of medicinal products. We conducted a lessons learnt analysis of impact studies completed between 2015 and 2023. We surveyed PRAC Sponsors and (Co-)Rapporteurs involved in the evaluation of 12 impact studies (10 commissioned by EMA and 2 conducted collaboratively by Member States) to explore how these support regulatory decision-making. Questions covered achievement of study objectives, risk minimisation effectiveness, added value for regulatory decision-making, and recommendations for future impact studies. Themes were generated using thematic content analysis. Survey responses from 15 PRAC Sponsors and (Co-)Rapporteurs from 10 European Union Member States were included in the analysis. Among four cross-sectional surveys and eight drug utilisation studies, 50% achieved all objectives, the other studies partially due to limitations. Two studies concluded that risk minimisation measures were overall effective, two were effective with variation across countries, two were partially effective and four studies showed limited effectiveness. Two studies were deemed inconclusive due to limitations. The reasons for the limited effectiveness of risk minimisation may be explored using mixed-method approaches. Assessment of study feasibility and a priori discussion of effectiveness measurements is important. Despite limitations, impact research adds value to regulatory decision-making by addressing knowledge gaps and providing additional information on unintended consequences of regulatory interventions. Our recommendations will help to improve planning, conducting and interpretating future impact studies.

Somatosensory Processing Differences in Individuals With Developmental Coordination Disorder: A Pilot Study

Abstract Date Presented 03/22/24 This pilot study demonstrates the Spatial Movement Sense test as a feasible and objective assessment of somatosensory processing. We saw deficits in somatosensory processing in children with developmental coordination disorder (DCD) compared with controls. Primary Author and Speaker: Nicole Botha Additional Authors and Speakers: Virginia W. Chu Contributing Authors: Mahira Ali, Nouran Hussein Amin, Sheena Davis, Elsie Baker, Megan G. Pesci, Madison K. Bollinger

Feasibility Assessment of Implementing Semi-Interlocking Masonry as Infill Panels in Framed Building Construction

Feasibility Assessment of Implementing Semi-Interlocking Masonry as Infill Panels in Framed Building Construction

Protocol for a randomised controlled unblinded feasibility trial of HD-DRUM: a rhythmic movement training application for cognitive and motor symptoms in people with Huntington’s disease

IntroductionHuntington’s disease (HD) is an inherited neurodegenerative disease causing progressive cognitive and motor decline, largely due to basal ganglia (BG) atrophy. Rhythmic training offers promise as therapy to counteract BG-regulated...

Feasibility assessment

Feasibility assessment

Optimization and performance evaluation of a novel absorption-based atmospheric water generator system for enhanced energy efficiency

Providing potable water poses a severe and chronic challenge for the human race. Conventional desalination systems are only feasible in large-scale production, requiring significant energy and a source of feeding water. Atmospheric water harvesting is a decentralized water production method that uses air humidity as a renewable water source. This technique holds promise for providing water even in hard-to-reach regions with no source of liquid water. However, the feasibility of this method declines in arid or semi-arid climates. In this paper, a novel absorption-based atmospheric water generator is proposed to improve the feasibility and cost-effectiveness of this technique to make it a viable method for producing fresh water, even in arid regions. The system is modeled using EES software to explore the effects of seven adjustable parameters on its performance. Subsequently, the modeled system is transferred into MATLAB through the utilization of artificial neural networks. A tri-objective optimization is then carried out using the genetic algorithm approach. The optimized system can produce 14016m3/year of fresh water, with a levelized cost of approximately 33.72$/m3, operating under hot and arid weather conditions (27°C and 25% RH). The data acquired from the system’s performance parameters is leveraged to derive correlations that are used to determine the system’s performance based on the input weather data. These correlations allow for the assessment of system feasibility across various regions and serve as a valuable shortcut in modeling similar systems for future research.

Ekoraya: Biodiversity Flipbook Based on Science Literacy

This research is motivated by the fact that scientific literacy in learning in Indonesia is still very lacking. The learning media that have been used so far are less varied and limited, teachers have also never applied learning media based on scientific literacy in the classroom. The objectives of this study are: (1) to find out the process of developing learning media, (2) to find out the feasibility of learning media and, (3) to find out the practicality of learning media. This study uses the Research and Development (RnD) method. Media development uses the ADDIE model. The subjects in this study were 27 students of grade V at SDN 007 Samarinda Ulu. Data collection techniques used interviews, questionnaires and documentation. The research instruments used were material expert feasibility assessment questionnaires, student response questionnaires and teacher response questionnaires. The results of this study were; feasibility tests by material experts of 94% with the category "Very Feasible", feasibility tests by media experts of 86% with the category "Very Feasible". Then, the assessment of media by small groups was 91.77% in the category of "Very Practical", the large group test was 88.35% in the category of "Very Practical", and the results of the media assessment by teachers were 96.47% in the category of "Very Practical" for use in learning.

Digital Platforms and the Financial Feasibility of Halal Frozen Food Marketing: A Feasibility Assessment

The Indonesian government issued a national policy of large-scale social restrictions in 2020 to 2021. At the same time, there was an increase in internet users in Indonesia which led to an increase in the use of the Tiktok mobile application. Both incidents made halal frozen food producers in Bogor market their products using mobile applications. Until now, there has been no research that calculates the financial feasibility of marketing halal frozen food using mobile applications. This study aims to determine the financial feasibility of marketing halal frozen food produced by PT XYZ using the TikTok mobile application. The financial feasibility analysis in this study uses a quantitative method by calculating income and assessing investment feasibility based on cash flow in the form of an R/C ratio. Researchers conducted observations and interviews as data collection techniques. The research location and respondents were selected purposively. The types of research data used are primary data and secondary data. Based on the results of the study, the net profit received by the company increased by IDR 118,714,448 with an R/C ratio of 2.52, meaning that every cost incurred of IDR 1 will get an income of IDR 2.52. From the explanation above, the results of this study prove that marketing of halal frozen food at PT XYZ Bogor using mobile applications is feasible and profitable. The implication of this study is to recommend halal frozen food producers in countries with increasing internet usage trends to market using mobile applications in order to obtain maximum profit.

Virtual Assessment of Functional Mobility in Lower Extremity Prosthesis Clients: An Exploratory Study

ObjectiveTo investigate the relationship between patient perception of lower extremity function and a home-based virtual clinician assessment of mobility in lower limb prosthesis clients. DesignDescriptive observational study using a clinician-administered functional mobility survey and timed Up and Go test to assess lower extremity function under supervision. SettingHealth Insurance Portability and Accountability Act-compliant online virtual platform. ParticipantsTwelve lower limb loss clients currently using prostheses, aged ≥19 years, not pregnant, and with no stroke, seizure disorder, or cancer. InterventionsNot applicable. Main Outcome MeasuresMain outcomes were mobility survey scores and mean timed Up and Go duration. ResultsMost participants reported significant ease of completing basic indoor ambulation and toileting tasks (66%-75%) and significant difficulty in running or prolonged ambulation activities (83%) requiring use of lower limb prosthesis. Timed Up and Go test was faster (11.0±2.9 s) than the reference range for transtibial prosthesis users and negatively associated with self-reported lower extremity functional status (r=−.70, P=.02). ConclusionsSelf-reported movement with lower limb prostheses at home and evaluation of mobility via a virtual platform is a feasible assessment modality that may reduce the frequency of therapy visits, defray some rehabilitation costs, and minimize the travel burden to distant prosthetic clinics.

Combined strategies for green roof incentive policies in Lisbon: Evaluating the potentiality of concession grants and identifying priority intervention areas

Incentive policies to promote new technologies is a strategy often employed by policymakers and governments. In some cities worldwide, mechanisms to encourage the adoption of Green Roofs (GR) have been implemented over the years. Although GR is not a new technology, the use of incentives, such as subsidies and tax abatements and/or exemptions, is still a recent strategy in many countries. The study covered in this paper proposes to explore the potential of combined incentive mechanisms for green roofs, using direct incentives (financial subsidies) and indirect incentives (tax/fee rebates). The granting incentives were verified by the feasibility assessment from both private (saved money) and public perspectives (reduction in municipal revenue) using scenarios of abatement percentages for fees and taxes and combining direct and indirect incentives. In addition, priority intervention areas for the installation of green roofs were defined based on three parameters: (i) the proportion of existing green spaces, (ii) urban heat islands and (iii) the potential of the building stock for green roof retrofit. The results show that granting a combined solution can be an effective option for facilitating the implementation of green roof projects. Moreover, the study serves as a decision support guide for politicians, urban planners, and public managers to formulate incentive proposals and make well-informed decisions regarding the incentive policies for GR.

Feasibility and sensitivity assessment of various heads for micro-hydropower plant design in the Deluwang watershed, Indonesia

ABSTRACT The escalating global demand for electrical energy, including in Indonesia, underscores the need for renewable energy sources like micro-hydropower plants (MHPs). This study examines the financial feasibility and sensitivity of MHP projects in the Deluwang watershed, Situbondo Regency, Indonesia. Three cases with varying head elevations and discharge rates were analyzed, utilizing crossflow turbines. Case 1, with the highest head and discharge, emerged as the most profitable, demonstrating the highest values for Net Present Value (NPV), Benefit–Cost Ratio (BCR), and Internal Rate of Return (IRR). The study found that on-grid systems, despite higher initial costs, offer more stable revenue and faster payback periods compared to off-grid systems. Sensitivity analysis revealed the on-grid method's resilience to fluctuations in interest rates, project lifespan, and river discharge, maintaining feasibility with up to an 80% reduction in discharge over 15 years. This highlights the importance of strategic planning in MHP design, considering head and discharge rates to optimize power generation. The findings provide valuable insights for renewable energy development, contributing to Indonesia's energy needs and local socio-economic benefits. Future research should further explore the socio-economic impacts of MHP installations to enhance their development and sustainability.

Preliminary Sizing of High-Altitude Airships Featuring Atmospheric Ionic Thrusters: An Initial Feasibility Assessment

When it comes to computing the values of variables defining the preliminary sizing of an airship, a few standardized approaches are available in the existing literature. However, when including a disruptive technology in the design is required, sizing procedures need to be amended, so as to be able to deal with the features of any additional novel item. This is the case of atmospheric ionic thrusters, a promising propulsive technology based on electric power, where thrusters feature no moving parts and are relatively cheap to manufacture. The present contribution proposes modifications to an existing airship design technique, originally conceived accounting for standard electro-mechanical thrusters, so as to cope with the specific features of new atmospheric ionic thrusters. After introducing this design procedure in detail, its potential is tested by showing results from feasibility studies on an example airship intended for a high-altitude mission. Concurrently, the so-obtained results allow the demonstration of the sizing features corresponding to the adoption of atmospheric ionic thrusters at the current level of technology, comparing them to what is obtained for the same mission when employing a standard electro-mechanical propulsion system.

INNOVATIVE LEARNING MEDIA IN TEACHING 2D DRAWING MODIFICATION WITH CAD TECHNOLOGY

The lack of understanding of students on 2D drawing modification material using CAD is the background for this research. The purpose of this study is to produce products in the form of video tutorial learning media, knowing the feasibility of experts, knowing user responses, and knowing the improvement of learning outcomes after using media. This study used quantitative research methods with a pre-experimental research design with the type of one group pre-test post-test design. Purposive sampling was conducted to select 34 samples from TPM grade XI learners. This research produces video tutorial learning media. The results of the feasibility assessment conducted by show that the video tutorial learning media that has been made is declared "very feasible". The results of media user responses obtained the category "very good". Learning outcomes after using video tutorial learning media have increased, this is reflected in the increase in student learning outcomes measured through the use of n-gain with an average score of 0.38 in the "medium" category. Thus, it can be concluded that this video tutorial learning media is very feasible for use on manufacturing engineering drawing elements.

INCORPORATING ETHNOMATHEMATICS AND REALISTIC MATHEMATICS EDUCATION ON DEVELOPING MATHEMATICS CONNECTION USING THE MENARA KUDUS

This research was motivated by students' low mathematical connections and lack of knowledge about the local culture around where they live. This research aims to develop a student digital worksheet using the concepts of ethnomathematics and Realistic Mathematics Education following the ADDIE procedure. A number of 30 students of year five in a primary school in Kudus District, Province of Central Java, Indonesia, involved in the study. The learning material used the local cultural object namely Menara Kudus. This bulding is part of muslim gathering venue and known its adaptation to the Hinduism as it was built during the era. A digital worksheet is defined as a set learning activity that can be accessed using electronic gadgets, like computer or smartphone. Validation of the development resutls included experts and students to collect data on the feasibility assessment of the digital worksheet which consists of assessments by material experts and media experts. In addition, the use of web based interactive worksheets at Menara Kudus based on Ethno–RME shows a significant increase in students' mathematical connections. This means that the Ethno–RME based Digital worksheet at the Menara Kudus was declared feasible and can be used in mathematics learning.

Feasibility assessment of inspiration breath-hold motion management for tumor tracking during cone-beam computed tomography for setup and radiotherapy in Veterinary Medicine: A pilot study.

Radiotherapy (RT) for lung or liver tumors can be challenging due to respiration-induced organ motion (RIOM). There are some methodological solutions to minimize RIOM. We explored a new approach to evaluate the feasibility and reproducibility of RIOM during RT with five total client-owned tumor-bearing animals using a remote-triggered breath-hold ventilator under general anesthesia during image acquisition and RT. There was one stereotactic body radiotherapy, one conventionally fractionated definitive intent, and three conventionally fractionated palliative intent RT cases. Based on repeated cone beam CT, there were no treatment table shifts required prior to initiating beam on. No clinically significant complications such as hypotension occurred during anesthesia. This technique appeared to be safe in this group of patients and was easily clinically implemented and highly reproducible. More complete follow-up data and larger studies are needed to evaluate clinical outcomes with this breath-hold ventilator technique in veterinary RT.

Development of a Chemistry Module on Buffer Solutions Using Dual Representations Assisted by Animation

Buffer solutions are a crucial concept in chemistry that students often find difficult to grasp. An effective method to enhance students' understanding is through the use of dual representations assisted by animation. Dual representations involve using various forms of visualization, such as diagrams, graphs, and animations, to help students comprehend abstract concepts more effectively. The research type employed is research and development (RD) using a 4-D model consisting of four stages: define, design, develop, and disseminate. The research subjects were 26 students from class XII MIPA 1 SMA Negeri 5 Banda Aceh. Data collection techniques were conducted by distributing questionnaires for student needs analysis, module and animation feasibility assessment, educator response to modules and animations, and student understanding tests. The developed module obtained very good assessment results from 2 validators with an average percentage of 89.16%, while the animation media received very good assessment results with an average percentage of 80.43%. Educators' responses to modules and animations were categorized as very good, with percentages of 94.17 and 95.84% respectively. Students' responses were also categorized as very good with an average percentage of 87.2%. The results of students' understanding were categorized as good with an overall score of 82.60%. Based on the results of this research, it is concluded that the animation-assisted multiple representation module on buffer solution material is highly suitable for use as teaching material in the learning process

Hemodynamic evaluation of biomaterial-based surgery for Tetralogy of Fallot using a biorobotic heart, in silico, and ovine models.

Tetralogy of Fallot is a congenital heart disease affecting newborns and involves stenosis of the right ventricular outflow tract (RVOT). Surgical correction often widens the RVOT with a transannular enlargement patch, but this causes issues including pulmonary valve insufficiency and progressive right ventricle failure. A monocusp valve can prevent pulmonary regurgitation; however, valve failure resulting from factors including leaflet design, morphology, and immune response can occur, ultimately resulting in pulmonary insufficiency. A multimodal platform to quantitatively evaluate the effect of shape, size, and material on clinical outcomes could optimize monocusp design. This study introduces a benchtop soft biorobotic heart model, a computational fluid model of the RVOT, and a monocusp valve made from an entirely biological cell-assembled extracellular matrix (CAM) to tackle the multifaceted issue of monocusp failure. The hydrodynamic and mechanical performance of RVOT repair strategies was assessed in biorobotic and computational platforms. The monocusp valve design was validated in vivo in ovine models through echocardiography, cardiac magnetic resonance, and catheterization. These models supported assessment of surgical feasibility, handling, suturability, and hemodynamic and mechanical monocusp capabilities. The CAM-based monocusp offered a competent pulmonary valve with regurgitation of 4.6 ± 0.9% and a transvalvular pressure gradient of 4.3 ± 1.4 millimeters of mercury after 7 days of implantation in sheep. The biorobotic heart model, in silico analysis, and in vivo RVOT modeling allowed iteration in monocusp design not now feasible in a clinical environment and will support future surgical testing of biomaterials for complex congenital heart malformations.

An open-label, randomized controlled trial to assess a ketogenic diet in critically ill patients with sepsis.

Patients with sepsis experience metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutrition. A ketogenic diet (KD) may offer an immunologically advantageous alternative, although clinical evidence is limited. We conducted a single-center, open-label, randomized controlled trial to assess whether a KD could induce stable ketosis in critically ill patients with sepsis. Secondary outcomes included assessment of feasibility and safety of KD, as well as explorative analysis of clinical and immunological characteristics. Forty critically ill adults were randomized to either a ketogenic or standard high-carbohydrate diet. Stable ketosis was achieved in all KD patients, with significant increases in β-hydroxybutyrate levels compared with controls [mean difference 1.4 milimoles per liter; 95% confidence interval (CI): 1.0 to 1.8; P < 0.001). No major adverse events or harmful metabolic side effects (acidosis, dysglycemia, or dyslipidemia) were observed. After day 4, none of the patients in the KD group required insulin treatment, whereas in the control group, insulin dependency ranged between 35% and 60% (P = 0.009). There were no differences in 30-day survival, but ventilation-free [incidence rate ratio (IRR) 1.7; 95% CI: 1.5 to 2.1; P < 0.001], vasopressor-free (IRR 1.7; 95% CI: 1.5 to 2.0; P < 0.001), dialysis-free (IRR 1.5; 95% CI: 1.3 to 1.8; P < 0.001), and intensive care unit-free days (IRR 1.7; 95% CI: 1.4 to 2.1; P < 0.001) were higher in the ketogenic group. Next-generation sequencing of CD4+/CD8+ T cells and protein analyses showed reduced immune dysregulation, with decreased gene expression of T-cell activation and signaling markers and lower pro-inflammatory cytokine secretion. This trial demonstrated the safe induction of a stable ketogenic state in sepsis, warranting larger trials to investigate potential benefits in sepsis-related organ dysfunction.

Assessment of techno-economic analyzes of grid-connected nuclear and PV/wind/battery/hydrogen renewable hybrid system for sustainable and clean energy production in Mersin-Türkiye

The main novelty in the presented paper is that it presents an energy analysis for a hybrid system that integrates nuclear power plants with wind/solar power plants for sustainable and clean energy production. In addition, excess energy is used to produce hydrogen. A techno-economic feasibility assessment is performed to ensure continuous electricity supply for hourly and peak residential load requirements in Mersin located in Türkiye. In the first stage of the study, suitable areas and sizes for solar and wind energy for energy production were determined with ArcGIS and Multi-Criteria Decision-Making methodologies. In the second stage, six scenarios were investigated in terms of electricity production, and excess energy was used for hydrogen production. The results brought out that more electricity was produced than the city's electricity consumption (5395 GWh) in all 6 scenarios considered. The maximum electricity production at a rate of 11900 GWh/yr and the maximum hydrogen at a rate of 132675 tons was produced in Scenario 4 with the cost of energy (0.31 $/kWh) and cost of hydrogen (12.6$/kgH2). In this scenario, the percentages of solar, wind and nuclear energy in total production 1 %, 12 %, and 87 %, respectively. According to the results, it was concluded that 236621 tons of carbon emissions were reduced when the city's energy needs were met according to the 6 scenarios in this study.

Interpretable machine learning model for activation energy prediction based on biomass properties

A thorough understanding of pyrolysis kinetics for biomass is crucial for the process design, feasibility assessment, and scale-up in industrial scenarios. To reduce the time and economic cost invested in obtaining experimental kinetic data by performing the thermogravimetric analysis, a data-driven machine learning method was proposed in the present work. Random forest (RF), gradient boosting decision tree (GBDT), and extreme gradient boosting (XGB) algorithms were utilized to predict the activation energy versus conversion range with ten input features from biomass characteristics. Among these XGB has shown the most competitive prediction accuracy with a coefficient of determination (R2) higher than 0.98 and a root mean squared error (RMSE) = 7.7 kJ/mol. To enhance the model interpretability of the derived model, a visualized analysis for individual impact and interactions of variables was conducted by Shapley additive explanation (SHAP). The top three significant inputs for the model established by the current dataset are conversion rate, volatile content, and moisture content. This work provides a quick and accurate kinetic prediction method for unexploited biomass and favors detailed insights into the complicated associations between biomass characteristics and pyrolysis kinetics.