Search results for: parenting effectiveness

Authors: Shara Toibayeva, Irbulat Utepbergenov, Lyazzat Issabekova, Aidana Bodesova

Abstract:

The article discusses the importance of quality assessment as a strategic tool in business and emphasizes the significance of the effectiveness of quality management systems (QMS) for enterprises. The evaluation of these systems takes into account the specificity of quality indicators, the multilevel nature of the system, and the need for optimal selection of the number of indicators and evaluation of the system state, which is critical for making rational management decisions. Methods and models of automated enterprise quality management are proposed, including an intelligent automated quality management system integrated with the Management Information and Control System. These systems make it possible to automate the implementation and support of QMS, increasing the validity, efficiency, and effectiveness of management decisions by automating the functions performed by decision makers and personnel. The paper also emphasizes the use of recurrent neural networks to improve automated quality management. Recurrent neural networks (RNNs) are used to analyze and process sequences of data, which is particularly useful in the context of document quality assessment and non-conformance detection in quality management systems. These networks are able to account for temporal dependencies and complex relationships between different data elements, which improves the accuracy and efficiency of automated decisions. The project was supported by a grant from the Ministry of Education and Science of the Republic of Kazakhstan under the Zhas Galym project No. AR 13268939, dedicated to research and development of digital technologies to ensure consistency of QMS regulatory documents.

Keywords: automated control system, quality management, document structure, formal language

Procedia PDF Downloads 41

Authors: Yang Yu, Jian Wang, Jiqiang Liu, Lei Han, Xudong He, Shaohua Lv

Abstract:

As the increasing network attacks become more and more complex, network situation assessment based on log analysis cannot meet the requirements to ensure network security because of the low quality of logs and alerts. This paper addresses the lack of consideration of security attributes of hosts and attacks in the network. Identity and effectiveness of Distributed Denial of Service (DDoS) are hard to be proved in risk assessment based on alerts and flow matching. This paper proposes a multi-dimension threat situation assessment method based on network security attributes. First, the paper offers an improved Common Vulnerability Scoring System (CVSS) calculation, which includes confident risk, integrity risk, availability risk and a weighted risk. Second, the paper introduces deterioration rate of properties collected by sensors in hosts and network, which aimed at assessing the time and level of DDoS attacks. Third, the paper introduces distribution of asset value in security attributes considering features of attacks and network, which aimed at assessing and show the whole situation. Experiments demonstrate that the approach reflects effectiveness and level of DDoS attacks, and the result can show the primary threat in network and security requirement of network. Through comparison and analysis, the method reflects more in security requirement and security risk situation than traditional methods based on alert and flow analyzing.

Keywords: DDoS evaluation, improved CVSS, network security attribute, threat situation assessment

Procedia PDF Downloads 210

Authors: Elnaz Alimi, Keriakoula Andriopoulos, Sam Boyer, Weronika Zuczek

Abstract:

Occupational therapists can use coaching strategies to guide parents in providing therapy for their children with developmental disabilities. Evidence from various fields has shown increased parental self-efficacy and positive child outcomes as benefits of home and community-based parent coaching models. A literature review was conducted to investigate the effectiveness of parent coaching interventions delivered in home and community settings for children with developmental disabilities ages 0-12, on a variety of parent and child outcomes. CINAHL Plus, PsycINFO, PubMed, OTseeker were used as databases. The inclusion criteria consisted of: children with developmental disabilities ages 0-12 and their parents, parent coaching models conducted in the home and community, and parent and child outcomes. Studies were excluded if they were in a language other than English and published before 2000. Results showed that parent coaching interventions led to more positive therapy outcomes in child behaviors and symptoms related to their diagnosis or disorder. Additionally, coaching strategies had positive effects on parental satisfaction with therapy, parental self-efficacy, and family dynamics. Findings revealed decreased parental stress and improved parent-child relationships. Further research on parent coaching could involve studying the feasibility of coaching within occupational therapy specifically, incorporating cultural elements into coaching, qualitative studies on parental satisfaction with coaching, and measuring the quality of life outcomes for the whole family.

Keywords: coaching model, developmental disabilities, occupational therapy, pediatrics

Procedia PDF Downloads 194

Authors: Andy S.K. Cheng, Samuel Leung, Cindy Kwok, Hector Tsang

Abstract:

Background: Telephone counselling is one of the essential interventions that can be found in most of the Employee Assistance Programs (EAP). The purposes of this study were to (1) explore the trend of the telephone counselling from 2003-2016 in Hong Kong; (2) explore which EAP issue requires more follow-up; and 3) examine the relationship between the EAP issues and demographic data such as gender and job ranking. Method: Date of EAP services usage was collected from EAP providers in Hong Kong during 2003-2016. EAP issues were categorized into two domains, namely workplace issues and personal issues. Each domain has 12 sub-categories. Two hypotheses were formulated in this study (1) there was a gender difference in EAP issues and the follow-up hours; and (2) there was a significant difference between job ranking, EAP issues and follow-up hours. Results: A total of eight hundred and ninety-three valid cases were identified for analysis. Of them, three hundred and forty-three cases sought for follow-up. The duration of follow-up by hours was calculated for each of the follow-up cases. The results of the study shows that the top three workplace issues that required the longest duration of follow-up were (1) workload, (2) supervisor-subordinate relationship; and (3) team member’s relationship. On the other hand, the top three personal issues that required the longest duration of follow-up were (1) parenting/parent-child relationship, (2) family care, and (3) marital relationship. Two-way ANOVA was performed to compare the total follow-up hours (excluding first intake) between gender and EAP issues. There was no statistical significance for gender (p =.891), but a statistically significant main effect for EAP issues (p <.001) was found. Post-hoc analysis (Tukey’s test) showed that total follow-up hour in personal issues was statistically significant higher than that in handling workplace issues (p <.001). However, there was no statistically significant interaction effect between gender and EAP issues (p=.879) and between job ranking and EAP issues (p=.843). Conclusion: Telephone counselling is a very common intervention in addressing EAP issues arising from workplace and personal level in Hong Kong. It was frequently used to handle interpersonal relationships and the service usage was independent of gender and job ranking.

Keywords: employee assistance program, follow-up time, interpersonal relationships, telephone counselling

Procedia PDF Downloads 216

Authors: Rujnan Tuna, Ayse Cil Akinci

Abstract:

Work life takes up an important place in human life, and an employed person faces many stimuli from internal and external environments and is affected by them in a positive or negative way. Also, the handover process, which is the process of sharing information about the patient with other health professionals, is an important criterion to maintain patient care and enhance the quality of care provided. Handover is a key component for sustaining daily basic clinical practices and is also essential to maintain the safe patient care. This investigation followed a descriptive and correlation design in order to establish job stress and the handover efficiency of nurses and the relationship in between. The study was conducted with 192 nurses working in a public hospital in Istanbul between January and March 2017. Descriptive information form, Job Stressors Scale, and Handover Evaluation Scale were used to collect the data of the study. The data were analyzed by using IBM SPSS Statistics 22.0 statistical software. Approvals from participants, managers of institution, and ethics committee were taken for the study. As a result of the research, it was found that job stress was above the median value, and the highest score in the ‘work role conflict’ subdimension. Also, it was found that the effectiveness of the nurses' handover effectiviness was above the median value and the highest score in the ‘quality of information’ subdimension. In the study, there was a negatively weak correlation between ‘work role overload’ subdimension of Job Stressors Scale and ‘interaction and support’ subdimension of Handover Evaluation Scale. There is a need for further study in order to maintain patient safety.

Keywords: handover, job stress, nurse, patient

Procedia PDF Downloads 169

Authors: Pradipta Risang Ratna Sambawa, Driya Herseta, Mahendra Fajri Nugraha

Abstract:

In 2020, PT Petrokimia Gresik implemented a program to increase the ROP (Run Of Pile) production rate at the Phosphate Fertilizer 1 plant, causing an increase in scrubbing water consumption in the 100/200 area unit. This increase in water consumption causes a higher discharge of wastewater, which can further cause local flooding, especially during the rainy season. The 100/200 area of the Phosphate Fertilizer 1 plant is close to the warehouse and is often a passing area for trucks transporting raw materials. This causes the pH in the wastewater to become acidic (the worst point is up to pH 1). The problem of flooding and exposure to acidic wastewater in the 100/200 area of Phosphate Fertilizer Plant 1 was then resolved by PT Petrokimia Gresik through wastewater optimization steps called the 3R program (Reduce, Reuse, and Recycle). The 3R (Reduce, reuse, and recycle) program consists of an air consumption reduction program by considering the liquid/gas ratio in scrubbing unit of 100/200 Phosphate Fertilizer 1 plant, creating a wastewater interconnection line so that wastewater from unit 100/200 can be used as scrubbing water in the Phonska 1, Phonska 2, Phonska 3 and unit 300 Phosphate Fertilizer 1 plant and increasing scrubbing effectiveness through scrubbing effectiveness simulations. Through a series of wastewater optimization programs, PT Petrokimia Gresik has succeeded in reducing NaOH consumption for neutralization up to 2,880 kg/day or equivalent in saving up to 314,359.76 dollars/year and reducing process water consumption up to 600 m3/day or equivalent in saving up to 63,739.62 dollars/year.

Keywords: fertilizer, phosphate fertilizer, wastewater, wastewater treatment, water management

Procedia PDF Downloads 29

Authors: Najmeh Hamid, Vajiheh Hamedy , Zahra Rostamianasl

Abstract:

Background: Cancer is one of the medical problems that have been associated with pain. Moreover, the pain is combined with negative emotions such as anxiety, depression and anger. Poor pain management causes negative effects on the quality of life, which results in negative effects that continue a long time after the painful experiences. Objectives: The aim of this research was to compare the effectiveness of Common Cognitive Behavioral Therapy for Pain and its computerized version on the reduction of pain intensity, depression, anger and anxiety in children with cancer. Methods: The research method of this “Randomized Controlled Clinical Trial” was a pre, post-test and follow-up with a control group. In this research, we have examined the effectiveness of Common Cognitive Behavioral Therapy for Pain and its computerized version on the reduction of pain intensity, anxiety, depression and anger in children with cancer in Ahvaz. Two psychological interventions (cognitive behavioral therapy for pain and the computerized version) were compared with the control group. The sample consisted of 60 children aged 8 to 12 years old with different types of cancer at Shafa hospital in Ahwaz. According to the including and excluding criteria such as age, socioeconomic status, clinical diagnostic interview and other criteria, 60 subjects were selected. Then, randomly, 45 subjects were selected. The subjects were randomly divided into three groups of 15 (two experimental and one control group). The research instruments included Spielberger Anxiety Inventory (STAY-2) and International Pain Measurement Scale. The first experimental group received 6 sessions of cognitive-behavioral therapy for 6 weeks, and the second group was subjected to a computerized version of cognitive-behavioral therapy for 6 weeks, but the control group did not receive any interventions. For ethical considerations, a version of computerized cognitive-behavioral therapy was provided to them. After 6 weeks, all three groups were evaluated as post-test and eventually after a one-month follow-up. Results: The findings of this study indicated that both interventions could reduce the negative emotions (pain, anger, anxiety, depression) associated with cancer in children in comparison with a control group (p<0.0001). In addition, there were no significant differences between the two interventions (p<0.01). It means both interventions are useful for reducing the negative effects of pain and enhancing adjustment. Conclusion: we can use CBT in situations in which there is no access to psychologists and psychological services. In addition, it can be a useful alternative to conventional psychological interventions.

Keywords: pain, children, psychological intervention, cancer, anger, anxiety, depression

Procedia PDF Downloads 80

Authors: Romella C. Lina, Matthew Daniel V. Leysa, Zarah D. F. Libozada, Maria Francesca I. Lirio, Angelo A. Liwag, Gabriel D. Ramos, Margaret M. Natividad

Abstract:

This study aimed to determine the effectiveness of Buteyko Method in asthma control and quality of life of school-age children wherein a pretest-posttest design was utilized to measure the changes after the administration of Buteyko Method. Fourteen (14) subjects with bronchial asthma, aged 7-11 participated in the study. They were equally divided into two groups: the control group received no intervention while the experimental group was asked to attend sessions of Buteyko Method lecture and demonstration. The experimental group was visited for three (3) consecutive weeks to monitor their progress and compliance. Both groups were asked to answer ACQ pre- and post-intervention and PAQLQ before the start of the intervention phase and every week during the follow-up visits. In comparing the asthma control pre-test and post-test mean scores of the control group, no significant difference was noted (p=0.177) while the experimental group showed a significant difference after the administration of Buteyko Method (p=0.002). Moreover, the quality of life pre-test and post-test mean scores of the control group showed no significant difference in any week within one month of follow-up (p=0.736, 0.604, 0.689) while the experimental group showed a significant difference on the third week (p = 0.035) and fourth week (p=0.002) but no significant difference on the second week (p=0.111). Therefore, the use of Buteyko Method within 3-4 weeks as an adjunct to conventional management of asthma helps in improving asthma control and quality of life of school-age children.

Keywords: Buteyko Method, asthma, school-age children, asthma control, quality of life

Procedia PDF Downloads 424

Authors: Marie-Claude Richard, Amelie Bolduc-Mokhtar, Mathieu Parent

Abstract:

People who have experienced maltreatment in childhood subsequently face many parenting issues of their own, in particular when it comes to distancing themselves from the abusive behaviors they were exposed and had access to positive role models. Few studies have explored the factors explaining the ability to break the generational cycle of child maltreatment. However, deeper knowledge of the factors associated with intergenerational discontinuity could facilitate the development of innovative interventions and increase the preventive potential of existing programs. This poster presentation will be about a better understanding of the intergenerational transmission of maltreatment (IGTM) from the perspective of both youth protection workers and parents receiving child protection services. The data used to meet this goal were collected from a group interview with eight youth protection workers whose caseloads involved IGTM situations and through semi-structured interviews with four parents with a history of child protection services and who were currently receiving such services for at least one of their children. In the view of the youth protection workers, the IGTM refers to everything that is transmitted and not transmitted from one generation to the next within a family. The study participants painted quite a bleak portrait of the families affected by IGTM. However, three main avenues of intervention were mentioned by the participants: working within the network, favoring long-term interventions and being empathic. The results also show that the mothers were in a trajectory of intergenerational discontinuity in child maltreatment. Support from their families and friends as well as from formal support services brought out some possible explanatory factors for intergenerational discontinuity in child maltreatment. From a prevention perspective, developing meaningful and trusting relationships seems a source of resilience for parents who were placed in the care of the child protection system as children. The small number of participants limits the generalizability of these results. The difficulty of recruiting parents is a substantial challenge regarding gaining knowledge on the intergenerational transmission of child maltreatment. Future studies should examine this question and seek to develop effective strategies to help recruit study participants.

Keywords: child maltreatment, intergenerational transmission, prevention, qualitative data

Procedia PDF Downloads 193

Authors: Abdool Qaiyum Mohabuth, Syed Munir Ahmad

Abstract:

Assessment enables students to focus on their learning, assessment. It engages them to work hard and motivates them in devoting time to their studies. Student learning is directly influenced by the type of assessment involved in the programme. Summative Assessment aims at providing measurement of student understanding. In fact, it is argued that summative assessment is used for reporting and reviewing, besides providing an overall judgement of achievement. While summative assessment is a well defined process for learning that takes place in the classroom environment, its application within the practice environment is still being researched. This paper discusses findings from a mixed-method study for exploring the effectiveness of summative assessment in practice learning. A survey questionnaire was designed for exploring the perceptions of mentors and students about summative assessment in practice learning. The questionnaire was administered to the University of Mauritius students and mentors who supervised students for their Work-Based Learning (WBL) practice at the respective placement settings. Some students, having undertaken their WBL practice, were interviewed, for capturing their views and experiences about the application of summative assessment in practice learning. Semi-structured interviews were also conducted with three experienced mentors who have assessed students on practice learning. The findings reveal that though learning in the workplace is entirely different from learning at the University, most students had positive experiences about their summative assessments in practice learning. They felt comfortable and confident to be assessed by their mentors in their placement settings and wished that the effort and time that they devoted to their learning be recognised and valued. Mentors on their side confirmed that the summative assessment is valid and reliable, enabling them to better monitor and coach students to achieve the expected learning outcomes.

Keywords: practice learning, judgement, summative assessment, knowledge, skills, workplace

Procedia PDF Downloads 342

Authors: Reza Johari Fard, Najmeh Cheraghi, Parvin Ehtesham Zadeh, Parviz Asgari

Abstract:

The aim of this study was to investigate and comparison of the effectiveness of schema mode therapy and emotionally focused couples therapy in attachment styles (secure, avoidant, and anxious) in couples with marital conflict in a quasiexperimental method in a pretest, posttest, and follow up design with a control group. The statistical population of the study included all the couples with marital conflict who visited the Mehrana counseling center in 2019 in Ahvaz, Iran 45 couples were selected by voluntary sampling method and randomly divided into two experimental groups and one control group (15 pairs in each group). The participants completed the Adult Attachment Scale (Hazan and Shaver). The experimental groups underwent schema mode therapy and emotionally focused couples therapy for 12 sessions, but the control group did not receive any intervention. The data were analyzed by the statistical analysis of repeated measures in SPSS-19 software. The results showed that both schema mode therapy and emotionally focused couples therapy are effective in increasing the secure attachment style and reducing avoidant and ambivalent attachment styles in couples with marital conflict. There was no significant difference between the schema mode therapy group and the emotionally focused couple's therapy group in attachment styles. Therefore, it is recommended that therapists and family counselors use these therapies along with other therapeutic interventions to increase secure attachment styles and reduce marital conflicts.

Keywords: schema mode therapy, emotional focused couple therapy, attachment styles, marital conflict

Procedia PDF Downloads 113

Authors: Mohsen Yaghmoor, Sima Radmanesh

Abstract:

Rapid environmental changes have been threaten the life of many organizations .Enabling and productivity of human resource should be considered as the most important issue in order to increase performance and ensure survival of the organizations. In this research, the effectiveness of management factory in productivity & inability of human resource have been identified and reviewed at glance. Afterward there were two questions they are “what are the factors effecting productivity and enabling of human resource” . And ”what are the priority order based on effective management of human resource in Fars Poultry Complex". A specified questionnaire has been designed in order to priorities and effectiveness of the identified factors. Six factors specify to consist of: Individual characteristics, teaching, motivation, partnership management, authority or power submission and job development that have most effect on organization. Then specify a questionnaire for priority and effect measurement of specified factor that reach after collect information and using statistical tests of keronchbakh alpha coefficient r=0.792 that we can say the questionnaire has sufficient reliability. After information analysis of specified six factors by Friedman test categorize their effect. Measurement on organization respectively consists of individual characteristics, job development or enrichment, authority submission, partnership management, teaching and motivation. At last it has been indicated to approaches to increase making power full and productivity of manpower.

Keywords: productivity, empowerment, enrichment, authority submission, partnership management, teaching, motivation

Procedia PDF Downloads 253

Authors: Yendo Hu, Xu-Yu Wu, Dylan Oh

Abstract:

GPS-Denied drones open the possibility of indoor applications, including dynamic arial surveillance, inspection, safety enforcement, and discovery. Indoor swarming further enhances these applications in accuracy, robustness, operational time, and coverage. For micro-drones, power management becomes a critical issue, given the battery payload restriction. This paper proposes an application enabling battery replacement solution that extends the micro-drone active phase without human intervention. First, a framework to quantify the effectiveness of a power management solution for a drone fleet is proposed. The operation-to-non-operation ratio, ONR, gives one a quantitative benchmark to measure the effectiveness of a power management solution. Second, a survey was carried out to evaluate the ONR performance for the various solutions. Third, through analysis, this paper proposes a solution tailored to the indoor micro-drone, suitable for swarming applications. The proposed automated battery replacement solution, along with a modified micro-drone architecture, was implemented along with the associated micro-drone. Fourth, the system was tested and compared with the various solutions within the industry. Results show that the proposed solution achieves an ONR value of 31, which is a 1-fold improvement of the best alternative option. The cost analysis shows a manufacturing cost of $25, which makes this approach viable for cost-sensitive markets (e.g., consumer). Further challenges remain in the area of drone design for automated battery replacement, landing pad/drone production, high-precision landing control, and ONR improvements.

Keywords: micro-drone, battery swap, battery replacement, battery recharge, landing pad, power management

Procedia PDF Downloads 122

Authors: Lizel Bertie, Kim Johnston

Abstract:

Parental emotion regulation plays a central role in the socialisation of emotion, especially when teaching young children to cope with negative emotions. Despite evidence which shows non-supportive parental responses to children’s expression of negative emotions has implications for the social and emotional development of the child, few studies have investigated risk factors which impact parental emotion socialisation processes. The current study aimed to explore the extent to which parental stress contributes to both difficulties in parental emotion regulation and non-supportive parental responses to children’s expression of negative emotions. In addition, the study examined whether parental use of expressive suppression as an emotion regulation strategy facilitates the influence of parental stress on non-supportive responses by testing the relations in a mediation model. A sample of 140 Australian adults, who identified as parents with children aged 5 to 10 years, completed an online questionnaire. The measures explored recent symptoms of depression, anxiety, and stress, the use of expressive suppression as an emotion regulation strategy, and hypothetical parental responses to scenarios related to children’s expression of negative emotions. A mediated regression indicated that parents who reported higher levels of stress also reported higher levels of expressive suppression as an emotion regulation strategy and increased use of non-supportive responses in relation to young children’s expression of negative emotions. These findings suggest that parents who experience heightened symptoms of stress are more likely to both suppress their emotions in parent-child interaction and engage in non-supportive responses. Furthermore, higher use of expressive suppression strongly predicted the use of non-supportive responses, despite the presence of parental stress. Contrary to expectation, no indirect effect of stress on non-supportive responses was observed via expressive suppression. The findings from the study suggest that parental stress may become a more salient manifestation of psychological distress in a sub-clinical population of parents while contributing to impaired parental responses. As such, the study offers support for targeting overarching factors such as difficulties in parental emotion regulation and stress management, not only as an intervention for parental psychological distress, but also the detection and prevention of maladaptive parenting practices.

Keywords: emotion regulation, emotion socialisation, expressive suppression, non-supportive responses, parental stress

Procedia PDF Downloads 160

Authors: Kamran Yazdanbakhsh, Somayeh Mahmoudi

Abstract:

Multiple sclerosis is the most common chronic disease of the central nervous system associated with demyelination of neurons and several demyelinated parts of the disease encompasses throughout the white matter and affects the sensory and motor function. This study compared the effectiveness of two methods of cognitive therapy and supportive-expressive therapy on the efficacy and quality of life in MS patients. This is an experimental project which has used developed group pretest - posttest and follow-up with 3 groups. The study included all patients with multiple sclerosis in 2013 that were members of the MS Society of Iran in Tehran. The sample included 45 patients with MS that were selected volunteerily of members of the MS society of Iran and randomly divided into three groups and pretest, posttest, and follow-up (three months) for the three groups had been done.The dimensions of quality of life in patients with multiple sclerosis scale, and general self-efficiency scale of Schwarzer and Jerusalem was used for collecting data. The results showed that there was a significant difference between the mean of quality of life scores at pretest, posttest, and follow-up of the experimental groups. There was no significant difference between the mean of quality of life of the experimental groups which means that both groups were effective and had the same effect. There was no significant difference between the mean of self-efficiency scores in control and experimental group in pretest, posttest and follow-up. Thus, by using cognitive and supportive-expressive group therapy we can improve quality of life in MS patients and make great strides in their mental health.

Keywords: cognitive group therapy, life style, MS, self-efficiency, supportive-expressive group therapy

Procedia PDF Downloads 486

Authors: James Jin, Weisi Xia, Runzhe Gao, Alain Vandal, Darren Svirkis, Andrew Hill

Abstract:

Background: Post-haemorrhoidectomy pain is concerned by patients/clinicians. Minimizing the postoperation pain is highly interested clinically. Combinations of topical cream targeting three hypothesised post-haemorrhoidectomy pain mechanisms were developed and their effectiveness were evaluated. Specifically, a multi-centred double-blinded randomized clinical trial (RCT) was conducted in adults undergoing excisional haemorrhoidectomy. The primary analysis was conveyed on the data collected to evaluate the effectiveness of the combinations of topical cream targeting three hypothesized pain mechanisms after the operations. Methods: 192 patients were randomly allocated to 4 arms (each arm has 48 patients), and each arm was provided with pain cream 10% metronidazole (M), M and 2% diltiazem (MD), M with 4% lidocaine (ML), or MDL, respectively. Patients were instructed to apply topical treatments three times a day for 7 days, and record outcomes for 14 days after the operations. The primary outcome was VAS pain on day 4. Covariates and models were selected in the blind review stage. Multiple imputations were applied for the missingness. LMER, GLMER models together with natural splines were applied. Sandwich estimators and Wald statistics were used. P-values < 0.05 were considered as significant. Conclusions: The addition of topical lidocaine or diltiazem to metronidazole does not add any benefit. ML had significantly better pain and recovery scores than combination MDL. Multimodal topical analgesia with ML after haemorrhoidectomy could be considered for further evaluation. Further trials considering only 3 arms (M, ML, MD) might be worth exploring.

Keywords: RCT, primary analysis, multiple imputation, pain scores, haemorrhoidectomy, analgesia, lmer

Procedia PDF Downloads 121

Authors: Gule Teri

Abstract:

The effective validation of analytical methods forms a crucial component of pharmaceutical manufacturing. However, traditional validation techniques can occasionally fail to fully account for inherent variations within datasets, which may result in inconsistent outcomes. This deficiency in validation accuracy is particularly noticeable when quantifying low concentrations of active pharmaceutical ingredients (APIs), excipients, or impurities, introducing a risk to the reliability of the results and, subsequently, the safety and effectiveness of the pharmaceutical products. In response to this challenge, we introduce an enhanced, tolerance-based Design of Experiments (DoE) approach for the validation of analytical methods. This approach distinctly measures variability with reference to tolerance or design margins, enhancing the precision and trustworthiness of the results. This method provides a systematic, statistically grounded validation technique that improves the truthfulness of results. It offers an essential tool for industry professionals aiming to guarantee the accuracy of their measurements, particularly for low-concentration components. By incorporating this innovative method, pharmaceutical manufacturers can substantially advance their validation processes, subsequently improving the overall quality and safety of their products. This paper delves deeper into the development, application, and advantages of this tolerance-based DoE approach and demonstrates its effectiveness using High-Performance Liquid Chromatography (HPLC) data for verification. This paper also discusses the potential implications and future applications of this method in enhancing pharmaceutical manufacturing practices and outcomes.

Keywords: tolerance-based design, design of experiments, analytical method validation, quality control, biopharmaceutical manufacturing

Procedia PDF Downloads 81

Authors: Zeplin Jiwa Husada Tarigan, Sautma Ronni Basana, Widjojo Suprapto

Abstract:

The ERP is integrating all data from various departments within the company into one data base. One department inputs the data and many other departments can access and use the data through the connected information system. As many manufacturing companies in Indonesia implement the ERP technology, many adjustments are to be made to align with the business process in the companies, especially the management policy and the competitive advantages. For companies that are successful in the initial implementation, they still have to maintain the process so that the initial success can develop along with the changing of business processes of the company. For companies which have already implemented the ERP successfully, they are still in need to maintain the system so that it can match up with the business development and changes. The continued success of the extended ERP implementation aims to achieve efficient and effective performance for the company. This research is distributing 100 questionnaires to manufacturing companies in East Java, Indonesia, which have implemented and have going live ERP for over five years. There are 90 returned questionnaires with ten disqualified questionnaires because they are from companies that implement ERP less than five years. There are only 80 questionnaires used as the data, with the response rate of 80%. Based on the data results and analysis with PLS (Partial Least Square), it is obtained that the organization commitment brings impacts to the user’s effectiveness and provides the adequate IT infrastructure. The user’s effectiveness brings impacts to the adequate IT infrastructure. The information quality of the company increases the implementation of the extended ERP in manufacturing companies in East Java, Indonesia.

Keywords: organization commitment, adequate IT infrastructure, information quality, extended ERP implementation

Procedia PDF Downloads 169

Authors: Betül Garda

Abstract:

Technological developments have diversified marketing activities of the tourism sector and it has increased tourism opportunities to compete on a global scale for tourism businesses. Tourism businesses have been forced to use its core skills and knowledge effectively with the increase in effectiveness of the technology in the global competitive environment. Tourism businesses have been reached beyond the traditional boundaries because of their commercial activities, so, the boundaries of the national market either eliminated or blurred. Therefore, the internet is the alternative promotion tool and distribution channel to providing unlimited facilities for tourism suppliers. For example, the internet provides an opportunity to reach customers on a global scale with direct email marketing, advertising, customer service, promotion, sales, and marketing. Tourism businesses have improved themselves with the continuous information flows and also they have provided the permanence of the changes. Especially in terms of tourism businesses, social media is emerging as an extremely important tool in the use of knowledge effectively. This research paper investigates the impact of social media on the tourism businesses. A social networking site is a type of social media that provides a platform for business and people to connect with each other. Social media is so flexible that it can be used for both leisure and business purposes. In the tourism industry, social networking sites are one of the essential tools that play an important and beneficial role. The topic that will be discussed in this research paper are consumer behavior, connection with consumers, effectiveness in terms of time and cost, creating brand awareness and building the image of the company, promoting company, targeting consumers in a conceptual frame.

Keywords: branding, promoting, social media in tourism, tourism marketing tools

Procedia PDF Downloads 285

Authors: Marcin Dębowski, Marcin Zieliński, Mirosław Krzemieniewski

Abstract:

As methane fermentation is a complex series of successive biochemical transformations, its subsequent stages are determined, to a various extent, by physical and chemical factors. A specific state of equilibrium is being settled in the functioning fermentation system between environmental conditions and the rate of biochemical reactions and products of successive transformations. In the case of physical factors that influence the effectiveness of methane fermentation transformations, the key significance is ascribed to temperature and intensity of biomass agitation. Among the chemical factors, significant are pH value, type, and availability of the culture medium (to put it simply: the C/N ratio) as well as the presence of toxic substances. One of the important elements which influence the effectiveness of methane fermentation is the pre-treatment of organic substrates and the mode in which the organic matter is made available to anaerobes. Out of all known and described methods for organic substrate pre-treatment before methane fermentation process, the ultrasound disintegration is one of the most interesting technologies. Investigations undertaken on the ultrasound field and the use of installations operating on the existing systems result principally from very wide and universal technological possibilities offered by the sonication process. This physical factor may induce deep physicochemical changes in ultrasonicated substrates that are highly beneficial from the viewpoint of methane fermentation processes. In this case, special role is ascribed to disintegration of biomass that is further subjected to methane fermentation. Once cell walls are damaged, cytoplasm and cellular enzymes are released. The released substances – either in dissolved or colloidal form – are immediately available to anaerobic bacteria for biodegradation. To ensure the maximal release of organic matter from dead biomass cells, disintegration processes are aimed to achieve particle size below 50 μm. It has been demonstrated in many research works and in systems operating in the technical scale that immediately after substrate supersonication the content of organic matter (characterized by COD, BOD5 and TOC indices) was increasing in the dissolved phase of sedimentation water. This phenomenon points to the immediate sonolysis of solid substances contained in the biomass and to the release of cell material, and consequently to the intensification of the hydrolytic phase of fermentation. It results in a significant reduction of fermentation time and increased effectiveness of production of gaseous metabolites of anaerobic bacteria. Because disintegration of Virginia fanpetals biomass via ultrasounds applied in order to intensify its conversion is a novel technique, it is often underestimated by exploiters of agri-biogas works. It has, however, many advantages that have a direct impact on its technological and economical superiority over thus far applied methods of biomass conversion. As for now, ultrasound disintegrators for biomass conversion are not produced on the mass-scale, but by specialized groups in scientific or R&D centers. Therefore, their quality and effectiveness are to a large extent determined by their manufacturers’ knowledge and skills in the fields of acoustics and electronic engineering.

Keywords: ultrasound disintegration, biomass, methane fermentation, biogas, Virginia fanpetals

Procedia PDF Downloads 369

Authors: Edwin Javier Cortes, Surupa Shaw

Abstract:

In recent years, there has been a growing emphasis on enhancing the efficiency and performance of wind and water turbines to meet the increasing demand for sustainable energy sources. One promising approach is the utilization of advanced flow control techniques to optimize aerodynamic performance. This paper explores the application of advanced flow control techniques in both wind and water turbines, aiming to maximize their efficiency and output. By manipulating the flow of air or water around the turbine blades, these techniques offer the potential to improve energy capture, reduce drag, and minimize turbulence-induced losses. The paper will review various flow control strategies, including passive and active techniques such as vortex generators, boundary layer suction, and plasma actuators. It will examine their effectiveness in optimizing turbine performance under different operating conditions and environmental factors. Furthermore, the paper will discuss the challenges and opportunities associated with implementing these techniques in practical turbine designs. It will consider factors such as cost-effectiveness, reliability, and scalability, as well as the potential impact on overall turbine efficiency and lifecycle. Through a comprehensive analysis of existing research and case studies, this paper aims to provide insights into the potential benefits and limitations of advanced flow control techniques for wind and water turbines. It will also highlight areas for future research and development, with the ultimate goal of advancing the state-of-the-art in turbine technology and accelerating the transition towards a more sustainable energy future.

Keywords: flow control, efficiency, passive control, active control

Procedia PDF Downloads 72

Authors: Zenah Gheblawi, Susan Armijo-Olivo, Elisa B. Pelai, Vaishali Sharma, Musa Tashfeen, Angela Fung, Francisca Claveria

Abstract:

Due to physiological differences between men and women, pain is experienced differently between the two sexes. Chronic pain disorders, notably temporomandibular disorders (TMDs), disproportionately affect women in diagnosis, and pain severity in opposition of their male counterparts. TMDs are a type of musculoskeletal disorder that target the masticatory muscles, temporalis muscle, and temporomandibular joints, causing considerable orofacial pain which can usually be referred to the neck and back. Therapeutic methods are scarce, and are not TMD-centered, with the latest research suggesting that subjects with chronic musculoskeletal pain disorders have abnormal alterations in the grey matter of their brains which can be remedied with exercise, and thus, decreasing the pain experienced. The aim of the study is to investigate the effects of exercise therapy in TMD female patients experiencing chronic jaw pain and to assess the consequential effects on brain activity. In a randomized controlled trial, the effectiveness of an exercise program to improve brain alterations and clinical outcomes in women with TMD pain will be tested. Women with chronic TMD pain will be randomized to either an intervention arm or a placebo control group. Women in the intervention arm will receive 8 weeks of progressive exercise of motor control training using visual feedback (MCTF) of the cervical muscles, twice per week. Women in the placebo arm will receive innocuous transcutaneous electrical nerve stimulation during 8 weeks as well. The primary outcomes will be changes in 1) pain, measured with the Visual Analogue Scale, 2) brain structure and networks, measured by fractional anisotropy (brain structure) and the blood-oxygen level dependent signal (brain networks). Outcomes will be measured at baseline, after 8 weeks of treatment, and 4 months after treatment ends and will determine effectiveness of MCTF in managing TMD, through improved clinical outcomes. Results will directly inform and guide clinicians in prescribing more effective interventions for women with TMD. This study is underway, and no results are available at this point. The results of this study will have substantial implications on the advancement in understanding the scope of plasticity the brain has in regards with pain, and how it can be used to improve the treatment and pain of women with TMD, and more generally, other musculoskeletal disorders.

Keywords: exercise therapy, musculoskeletal disorders, physical therapy, rehabilitation, tempomandibular disorders

Procedia PDF Downloads 293

Authors: Mohamed Saad Gad Elzoghby

Abstract:

Nanomaterials are widely used nowadays for the consolidation of degraded archaeological limestone. It’s one of the most predominant stones in monumental buildings and statuary works. It is exposed to different weathering processes that cause degradation and the presence of deterioration pattern as cracks, fissures, and granular disintegration. Nanomaterials have been applied to limestone consolidation. Among these nanomaterials are nanolimes, i.e., dispersions of lime nanoparticles in alcohols, and nano-silica, i.e., dispersions of silica nanoparticles in water, promising consolidating products for limestone. It was investigated and applied to overcome the disadvantages of traditional consolidation materials such as lime water, water glass, and paraliod. So, researchers investigated and tested the effectiveness of nanomaterials as consolidation materials for limestone. The present study includes an evaluation of some nanomaterials in consolidation limestone stone in comparison with traditional consolidants. These consolidation materials are nano calcium hydroxide nanolime, and nanosilica. The latter is known commercially as Nano Estel and the former Known as Nanorestore compared to traditional consolidants Wacker OH (ethyl silicate) and Paraloid B72 (a copolymer of ethyl methacrylate and methyl acrylate). The study evaluated the consolidation effectiveness of nanomaterials and traditional consolidants by using followed methods, characterization of physical properties of stone, scanning electron microscopy (SEM), X-ray diffractometry, Fourier transforms infrared spectroscopy, and mechanical properties. The study confirmed that nanomaterials were better in the distribution and encapsulation of calcite grains in limestone, and traditional materials were better in improving the physical properties of limestone. It demonstrated that good results could be achieved through mixtures of nanomaterials and traditional consolidants.

Keywords: nanomaterials, limestone, consolidation, evaluation, weathering, nanolime, nanosilica, scanning electron microscope

Procedia PDF Downloads 81

Authors: Rajkumar Ghosh

Abstract:

Water scarcity is a significant challenge in urban areas, even in smart cities (Lucknow, Bangalore, Jaipur, etc.) where efficient resource management is prioritized. The depletion of groundwater resources in Gomti Nagar, Lucknow, Uttar Pradesh, India is particularly severe, posing a significant challenge for sustainable development in the region. This study focuses on addressing the water shortage by investigating the effectiveness of rooftop rainwater harvesting systems (RTRWHs) as a sustainable approach to bridge the gap between groundwater recharge and extraction. The aim of this study is to assess the effectiveness of RTRWHs in reducing aquifer depletion and addressing the water scarcity issue in the Gomti Nagar region. The research methodology involves the utilization of RTRWHs as the primary method for collecting rainwater. RTRWHs will be implemented in residential and commercial buildings to maximize the collection of rainwater. Data for this study were collected through various sources such as government reports, surveys, and existing groundwater abstraction patterns. Statistical analysis and modelling techniques were employed to assess the current water situation, groundwater depletion rate, and the potential impact of implementing RTRWHs. The study reveals that the installation of RTRWHs in the Gomti Nagar region has a positive impact on addressing the water scarcity issue. Currently, RTRWHs cover only a small percentage of the total rainfall collected in the region. However, when RTRWHs are installed in all buildings, their influence on increasing water availability and reducing aquifer depletion will be significantly greater. The study also highlights the significant water imbalance in the region, emphasizing the urgent need for sustainable water management practices. This research contributes to the theoretical understanding of sustainable water management systems in smart cities. By highlighting the effectiveness of RTRWHs in reducing aquifer depletion, it emphasizes the importance of implementing such systems in urban areas. Data for this study were collected through various sources such as government reports, surveys, and existing groundwater abstraction patterns. The collected data were then analysed using statistical analysis and modelling techniques to assess the current water situation, groundwater depletion rate, and the potential impact of implementing RTRWHs. The findings of this study demonstrate that the implementation of RTRWHs can effectively mitigate the water scarcity crisis in Gomti Nagar. By reducing aquifer depletion and bridging the gap between groundwater recharge and extraction, RTRWHs offer a sustainable solution to the region's water scarcity challenges. Widespread adoption of RTRWHs in all buildings and integration into urban planning and development processes are crucial for efficient water management in smart cities like Gomti Nagar. These findings can serve as a basis for policymakers, urban planners, and developers to prioritize and incentivize the installation of RTRWHs as a potential solution to the water shortage crisis.

Keywords: water scarcity, urban areas, smart cities, resource management, groundwater depletion, rooftop rainwater harvesting systems, sustainable development, sustainable water management, mitigating water scarcity

Procedia PDF Downloads 78

Authors: Kunthida Kulprateepunya, Napat Boontiam, Bunthita Phuasa, Chatsuda Kankayant, Bantoeng Polsawat, Sumran Poontong

Abstract:

Frailty is the thin line between good health and illness. The syndrome is more common in the elderly who transition from strong to weak. (Vulnerability). Fragility can prevent and promote healthy recovery before it goes into disability. This research and development aim to analyze the situation analysis of frailty of the elderly, develop a program, and evaluate the effect of a health promotion program to prevent and solve the problem of frailty among the elderly. The research consisted of 3 phases: 1) analysis of the frailty situation, 2) development of a model, 3) evaluation of the effectiveness of the model. Samples were 328, 122 elderlies using the multi-stage random sampling method. The research instrument was a frailty questionnaire use of the five symptoms, the main characteristics were muscle weakness, slow walking, low physical activity. Fatigue and unintentional weight loss, criteria frailty use more than or equal to three or more symptoms are frailty. Data were analyzed by descriptive and t-test dependent test statistics. The findings showed three parts. First, frailty in the elderly was 23.05 percentage and 56.70% pre-frailty. Second, it was development of a health promotion program to prevent and solve the problem of frailty the elderly with a combination of Nine-Square Exercise, Elastic Band Exercise, Elastic Coconut Shell. Third, evaluation of the effectiveness of the model by comparison of the elderly's get up and go test, the average time before using the program was 14.42 and after using the program was 8.57. It was statistically significant at the .05 level. In conclusion, the findings can used to develop guidelines to promote the health of the frailty elderly.

Keywords: elderly, fragile, nine-square exercise, elastic coconut shell

Procedia PDF Downloads 105

Authors: Nikita Katyal, Shubham Jain

Abstract:

In today’s competitive business environment, the success of campaigns relies not only on their creation but also on effectively reaching the right customers. Campaigns often feature products that customers may not have considered or are unaware of, including popular items. This research aims to enhance retailer sales by leveraging an efficient recommender system that reminds targeted customers to purchase their preferred products and suggests additional items they hadn’t initially considered during a campaign. Our focus is on utilizing the recommender system to identify potential customers for a curated set of products selected by the marketing team for a specific campaign. Communicating with all customers can be time-consuming and costly, and irrelevant messages may harm customer loyalty. Therefore, the primary objective is to strategically select the right customers for a campaign, increasing sales and reducing communication costs. This paper provides valuable insights into connecting with the right customer segments to optimize revenue generation for businesses. The analysis shows that high-value customers (those generating the highest revenue) contributed to increases in average basket size, while win-back customers (with low engagement) and about to churn customers (those at risk of attrition) improved the effectiveness of marketing contacts by increasing engagement and reducing churn. Targeted communication, focused on revenue, also enhanced the quality of the relationship between the customer and the firm, helping to lower churn rates by engaging customers with suitable campaigns. This research provides empirical evidence supporting the theoretical benefits of targeting the right customers for a campaign.

Keywords: recommendation, ALS, marketing campaigns, target customers, churn

Procedia PDF Downloads 15

Authors: Marcin Zieliński, Marcin Dębowski, Mirosław Krzemieniewski

Abstract:

The anaerobic degradation of substrates is limited especially by the rate and effectiveness of the first (hydrolytic) stage of fermentation. This stage may be intensified through pre-treatment of substrate aimed at disintegration of the solid phase and destruction of substrate tissues and cells. The most frequently applied criterion of disintegration outcomes evaluation is the increase in biogas recovery owing to the possibility of its use for energetic purposes and, simultaneously, recovery of input energy consumed for the pre-treatment of substrate before fermentation. Hydrodynamic cavitation is one of the methods for organic substrate disintegration that has a high implementation potential. Cavitation is explained as the phenomenon of the formation of discontinuity cavities filled with vapor or gas in a liquid induced by pressure drop to the critical value. It is induced by a varying field of pressures. A void needs to occur in the flow in which the pressure first drops to the value close to the pressure of saturated vapor and then increases. The process of cavitation conducted under controlled conditions was found to significantly improve the effectiveness of anaerobic conversion of organic substrates having various characteristics. This phenomenon allows effective damage and disintegration of cellular and tissue structures. Disintegration of structures and release of organic compounds to the dissolved phase has a direct effect on the intensification of biogas production in the process of anaerobic fermentation, on reduced dry matter content in the post-fermentation sludge as well as a high degree of its hygienization and its increased susceptibility to dehydration. A device the efficiency of which was confirmed both in laboratory conditions and in systems operating in the technical scale is a hydrodynamic generator of cavitation. Cavitators, agitators and emulsifiers constructed and tested worldwide so far have been characterized by low efficiency and high energy demand. Many of them proved effective under laboratory conditions but failed under industrial ones. The only task successfully realized by these appliances and utilized on a wider scale is the heating of liquids. For this reason, their usability was limited to the function of heating installations. Design of the presented cavitation generator allows achieving satisfactory energy efficiency and enables its use under industrial conditions in depolymerization processes of biomass with various characteristics. Investigations conducted on the laboratory and industrial scale confirmed the effectiveness of applying cavitation in the process of biomass destruction. The use of the cavitation generator in laboratory studies for disintegration of sewage sludge allowed increasing biogas production by ca. 30% and shortening the treatment process by ca. 20 - 25%. The shortening of the technological process and increase of wastewater treatment plant effectiveness may delay investments aimed at increasing system output. The use of a mechanical cavitator and application of repeated cavitation process (4-6 times) enables significant acceleration of the biogassing process. In addition, mechanical cavitation accelerates increases in COD and VFA levels.

Keywords: hydrodynamic cavitation, pretreatment, biomass, methane fermentation, Virginia fanpetals

Procedia PDF Downloads 436

Authors: Maha Abdulmajeed, Nagwa Fahmy

Abstract:

Improving journalism practice in the UAE requires a clear understanding of the mid-career training environment; what Arab journalists’ think about the professional training available to them, what training needs they have and still not achieved, and what factors they think it could help to improve the mid-career training outcomes. This research paper examines the validity and effectiveness of mid-career professional journalistic training in the UAE. The research focuses on Arab journalists’ perceptions and attitudes towards professional training, and the state of journalistic training courses available to them, in comparison to modern trends of professional training. The two main objectives of this paper are to examine how different factors affect the effectiveness of the mid-career training offered to Arab Journalists in UAE, whether they are institutional factories, socio-economic factors, personal factors, etc. Then, to suggest a practical roadmap to improve the mid-career journalism training in the UAE. The research methodology combines qualitative and quantitative approaches. As researchers conduct in-depth interviews with a sample of Arab journalists in the UAE, Media outlets in UAE encompass private and governmental entities, with media products in Arabic and/or English, online and/or offline as well. Besides, content analysis will be applied to the available online and offline journalistic training courses offered to Arab journalists’ in UAE along the past three years. Research outcomes are expected to be helpful and practical to improve professional training in the UAE and to determine comprehensive and concrete criteria to provide up-to-date professional training, and to evaluate its validity. Results and research outcomes can help to better understand the current status of mid-career journalistic training in the UAE, to evaluate it based on studying both; the targeted trainees and the up-to-date journalistic training trends.

Keywords: Arab journalists, Arab journalism culture, journalism practice, journalism and technology

Procedia PDF Downloads 268

Authors: Mohamed Saad Gad Eloghby

Abstract:

Nanomaterials are widely used nowadays for the consolidation of degraded archaeological limestone. It’s one of the most predominant stones in monumental buildings and statuary works. Exposure to different weathering processes caused degradation and the presence of deterioration pattern as cracks, fissures, and granular disintegration. Nanomaterials have been applied to limestone consolidation. Among these nanomaterials are nanolimes, i.e., dispersions of lime nanoparticles in alcohols and nanosilica, i.e., dispersions of silica nanoparticles in water promising consolidating products for limestone. It was investigated and applied to overcome the disadvantages of traditional consolidation materials such as lime water, water glass and paraliod. So, researchers investigated and tested the effectiveness of nanomaterials as consolidation materials for limestone. The present study includes the evaluation of some nano materials in consolidation limestone stone in comparison with traditional consolidantes. These consolidation materials are nano calcium hydroxide nanolime and nanosilica. The latter is known commercially as Nano Estel and the former is known as Nanorestore compared to traditional consolidantes Wacker OH (ethyl silicate) and Paraloid B72 (a copolymer of ethyl methacrylate and methyl acrylate). The study evaluated the consolidation effectiveness of nanomaterials and traditional consolidantes by using followed methods, Characterization of physical properties of stone, Scanning electron microscopy (SEM), X-ray diffractometry, Fourier transform infrared spectroscopy and Mechanical properties. The study confirmed that nanomaterials were better in the distribution and encapsulation of calcite grains in limestone, and traditional materials were better in improving the physical properties of limestone. It demonstrated that good results can be achieved through mixtures of nanomaterials and traditional consolidants.

Keywords: nanomaterials, limestone, consolidation, evaluation, weathering, nanolime, nanosilica, scanning electron microscope

Procedia PDF Downloads 77

Authors: Kevin Yeo, Christine Hall, Babinchak Tim

Abstract:

BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)] anti-toxin is a mixture of equine immune globulin fragments indicated for the treatment of symptomatic botulism in adult and pediatric patients. The effectiveness of BAT anti-toxin is based on efficacy studies conducted in animal models. A general explanation of the pivotal animal studies, post market surveillance and outcomes of an observational patient registry for patients treated with BAT product distributed in the USA is briefly discussed. Overall it took 20 animal studies for two well-designed and appropriately powered pivotal efficacy studies – one in which the effectiveness of BAT was assessed against all 7 serotypes in the guinea pig, and the other where efficacy is confirmed in the Rhesus macaque using Serotype A. Clinical Experience for BAT to date involves approximately 600 adult and pediatric patients with suspected botulism. In pre-licensure, patient data was recorded under the US CDC expanded access program (259 adult and pediatric patients between 10 days to 88 years of age). In post licensure, greater than 350 patients to date have received BAT and been followed up by enhanced expanded access program. The analysis of the post market surveillance data provided a unique opportunity to demonstrate clinical benefit in the field study required by the animal rule. While the animal rule is applied because human efficacy studies are not ethical or feasible, a post-marketing requirement is to conduct a study to evaluate safety and clinical benefit when circumstances arise and demonstrate the favourable benefit-risk profile that supported licensure.

Keywords: botulism, threat, clinical benefit, observational patient registry

Procedia PDF Downloads 179