Designing Excellence and Quality Model for Training Centers of Primary Health Care: A Delphi Method Study.

PubMed

Tabrizi, Jafar-Sadegh; Farahbakhsh, Mostafa; Shahgoli, Javad; Rahbar, Mohammad Reza; Naghavi-Behzad, Mohammad; Ahadi, Hamid-Reza; Azami-Aghdash, Saber

2015-10-01

Excellence and quality models are comprehensive methods for improving the quality of healthcare. The aim of this study was to design excellence and quality model for training centers of primary health care using Delphi method. In this study, Delphi method was used. First, comprehensive information were collected using literature review. In extracted references, 39 models were identified from 34 countries and related sub-criteria and standards were extracted from 34 models (from primary 39 models). Then primary pattern including 8 criteria, 55 sub-criteria, and 236 standards was developed as a Delphi questionnaire and evaluated in four stages by 9 specialists of health care system in Tabriz and 50 specialists from all around the country. Designed primary model (8 criteria, 55 sub-criteria, and 236 standards) were concluded with 8 criteria, 45 sub-criteria, and 192 standards after 4 stages of evaluations by specialists. Major criteria of the model are leadership, strategic and operational planning, resource management, information analysis, human resources management, process management, costumer results, and functional results, where the top score was assigned as 1000 by specialists. Functional results had the maximum score of 195 whereas planning had the minimum score of 60. Furthermore the most and the least sub-criteria was for leadership with 10 sub-criteria and strategic planning with 3 sub-criteria, respectively. The model that introduced in this research has been designed following 34 reference models of the world. This model could provide a proper frame for managers of health system in improving quality.

Ares Project Overview - Quality in Design

NASA Technical Reports Server (NTRS)

Cianciola, Chris; Crane, Kenneth

2008-01-01

This presentation introduces the audience to the overall goals of the Ares Project, which include providing human access to low-Earth orbit, the Moon, and beyond. The presentation also provides an overview of with the vehicles that will execute those goals and progress made on the vehicles to date. The briefing will provide an introduction to Lean, Six Sigma, and Kaizen practices Ares will use to improve the overall effectiveness and quality of its efforts. Finally, the briefing includes a summary of Safety and Mission Assurance practices being implemented within[Ares to ensure safety and quality early in the design process. Integrating Safety and Mission Assurance in Design: This presentation describes how the Ares Projects are learning from the successes and failures of previous launch systems in order to maximize safety and reliability while maintaining fiscal responsibility. The Ares Projects are integrating Safer T and Mission Assurance into design activities and embracing independent assessments by Quality experts in thorough reviews of designs and processes. Incorporating Lean thinking into the design process, Ares is also streamlining existing processes and future manufacturing flows which will yield savings during production. Understanding the value of early involvement of Quality experts, the Ares Projects are leading launch vehicle development into the 21st century.

Design and Establishment of Quality Model of Fundamental Geographic Information Database

NASA Astrophysics Data System (ADS)

Ma, W.; Zhang, J.; Zhao, Y.; Zhang, P.; Dang, Y.; Zhao, T.

2018-04-01

In order to make the quality evaluation for the Fundamental Geographic Information Databases(FGIDB) more comprehensive, objective and accurate, this paper studies and establishes a quality model of FGIDB, which formed by the standardization of database construction and quality control, the conformity of data set quality and the functionality of database management system, and also designs the overall principles, contents and methods of the quality evaluation for FGIDB, providing the basis and reference for carry out quality control and quality evaluation for FGIDB. This paper designs the quality elements, evaluation items and properties of the Fundamental Geographic Information Database gradually based on the quality model framework. Connected organically, these quality elements and evaluation items constitute the quality model of the Fundamental Geographic Information Database. This model is the foundation for the quality demand stipulation and quality evaluation of the Fundamental Geographic Information Database, and is of great significance on the quality assurance in the design and development stage, the demand formulation in the testing evaluation stage, and the standard system construction for quality evaluation technology of the Fundamental Geographic Information Database.

Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study).

PubMed

Walsh, Timothy S; Kydonaki, Kalliopi; Antonelli, Jean; Stephen, Jacqueline; Lee, Robert J; Everingham, Kirsty; Hanley, Janet; Uutelo, Kimmo; Peltola, Petra; Weir, Christopher J

2016-03-04

To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs). 8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis. Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period. The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured. Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed. The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex

Course Design Using the House of Quality

ERIC Educational Resources Information Center

Peters, Michael H.; Kethley, R. Bryan; Bullington, Kimball

2005-01-01

This article reports on the use of the House of Quality to facilitate the design of a required operations management course in an MBA program. The House of Quality is a relatively new approach that is used in product or service design and total quality management. The faculty identified the decision issues it felt would be pertinent to the design…

From Design and Implementation to Impact of Quality Assurance: An Overview of Some Studies into What Impacts Improvement

ERIC Educational Resources Information Center

Westerheijden, Don F.; Hulpiau, Veerle; Waeytens, Kim

2007-01-01

Attention shifted in recent years from design and implementation to use and usefulness of quality assurance. Scientific studies focus increasingly on quality assurance's impact on curricula and individual teachers. Which factors influence follow-up activities and what is their relation to improvement of education? One factor that we single out is…

Development Design Model of Academic Quality Assurance at Private Islamic University Jakarta Indonesia

ERIC Educational Resources Information Center

Suprihatin, Krebet; Bin Mohamad Yusof, Hj. Abdul Raheem

2015-01-01

This study aims to evaluate the practice of academic quality assurance in design model based on seven aspects of quality are: curriculum design, teaching and learning, student assessment, student selection, support services, learning resources, and continuous improvement. The design study was conducted in two stages. The first stage is to obtain…

Incorporating Servqual-QFD with Taguchi Design for optimizing service quality design

NASA Astrophysics Data System (ADS)

Arbi Hadiyat, M.

2018-03-01

Deploying good service design in service companies has been updated issue in improving customer satisfaction, especially based on the level of service quality measured by Parasuraman’s SERVQUAL. Many researchers have been proposing methods in designing the service, and some of them are based on engineering viewpoint, especially by implementing the QFD method or even using robust Taguchi method. The QFD method would found the qualitative solution by generating the “how’s”, while Taguchi method gives more quantitative calculation in optimizing best solution. However, incorporating both QFD and Taguchi has been done in this paper and yields better design process. The purposes of this research is to evaluate the incorporated methods by implemented it to a case study, then analyze the result and see the robustness of those methods to customer perception of service quality. Started by measuring service attributes using SERVQUAL and find the improvement with QFD, the deployment of QFD solution then generated by defining Taguchi factors levels and calculating the Signal-to-noise ratio in its orthogonal array, and optimized Taguchi response then found. A case study was given for designing service in local bank. Afterward, the service design obtained from previous analysis was then evaluated and shows that it was still meet the customer satisfaction. Incorporating QFD and Taguchi has performed well and can be adopted and developed for another research for evaluating the robustness of result.

Incorporating Handling Qualities Analysis into Rotorcraft Conceptual Design

NASA Technical Reports Server (NTRS)

Lawrence, Ben

2014-01-01

This paper describes the initial development of a framework to incorporate handling qualities analyses into a rotorcraft conceptual design process. In particular, the paper describes how rotorcraft conceptual design level data can be used to generate flight dynamics models for handling qualities analyses. Also, methods are described that couple a basic stability augmentation system to the rotorcraft flight dynamics model to extend analysis to beyond that of the bare airframe. A methodology for calculating the handling qualities characteristics of the flight dynamics models and for comparing the results to ADS-33E criteria is described. Preliminary results from the application of the handling qualities analysis for variations in key rotorcraft design parameters of main rotor radius, blade chord, hub stiffness and flap moment of inertia are shown. Varying relationships, with counteracting trends for different handling qualities criteria and different flight speeds are exhibited, with the action of the control system playing a complex part in the outcomes. Overall, the paper demonstrates how a broad array of technical issues across flight dynamics stability and control, simulation and modeling, control law design and handling qualities testing and evaluation had to be confronted to implement even a moderately comprehensive handling qualities analysis of relatively low fidelity models. A key outstanding issue is to how to 'close the loop' with an overall design process, and options for the exploration of how to feedback handling qualities results to a conceptual design process are proposed for future work.

A quality by design (QbD) study on enoxaparin sodium loaded polymeric microspheres for colon-specific delivery.

PubMed

Hales, Dana; Vlase, Laurian; Porav, Sebastian Alin; Bodoki, Andreea; Barbu-Tudoran, Lucian; Achim, Marcela; Tomuță, Ioan

2017-03-30

The aim of this study was to apply quality by design (QbD) for pharmaceutical development of enoxaparin sodium microspheres for colon-specific delivery. The Process Parameters (CPPs) and Critical Quality Attributes (CQAs) were identified. A central composite experimental design was used in order to develop the design space of microspheres for colon-specific delivery that have the desired Quality Target Product Profile (QTPP). The CPPs studied were Eudragit® FS-30D/Eudragit® RS-PO ratio, poly(vinyl alcohol) (PVA) concentration and sodium chloride (NaCl) concentration. The encapsulation efficiency increased with NaCl concentration increase, the percentages of enoxaparin sodium reaching 94% for some formulations. Increasing the ratio Eudragit® FS-30D/Eudragit® RS-PO ensured a relatively complete release of enoxaparin sodium in the environment simulating the colonic pH. Based on these results, the optimum conditions were decided and the optimum formulation was prepared. The results obtained for the latter in terms of in vitro enoxaparin sodium release were good, the microparticles releasing only 9.42% enoxaparin sodium in acidic environment and 15.16% in the medium which simulated duodenal pH, but allowing the release of up to 89.24% in the medium which simulated colonic pH. The in vitro release profile of enoxaparin sodium was close to the ideal one, therefore the system was successfully designed using QbD approach. Copyright © 2017 Elsevier B.V. All rights reserved.

People’s Preferences of Urban Design Qualities for Walking on a Commercial Street

NASA Astrophysics Data System (ADS)

Ernawati, J.; Surjono; Sudarmo, B. S.

2018-03-01

This research aims to explore people’s preferences of urban design qualities for walking on a commercial street, with Kawi Street located in a commercial neighborhood in the town of Malang Indonesia as the case study. Based on a literature review, this study used eight urban design qualities, i.e., enclosure, legibility, human scale, transparency, complexity, coherence, linkage, and imageability. This study applied a survey research method using a self-administered paper-pencil questionnaire applying two measurement techniques: Likert scale was used to explore people’s evaluations of urban design qualities of the street, while multiple-rating scales were used to measure people’s preference for walking on the street. One hundred and ten people randomly selected as respondents. Regression analysis was employed to explore the influence of urban design qualities on people preference for walking. Results indicated four urban design qualities that affect people’s choice for walking on a commercial street, i.e., transparency, coherence, linkage, and imageability. Implications of the findings will be discussed in the paper.

Quality By Design: Concept To Applications.

PubMed

Swain, Suryakanta; Padhy, Rabinarayan; Jena, Bikash Ranjan; Babu, Sitty Manohar

2018-03-08

Quality by Design is associated to the modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also leads to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify desire and required product performance report such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality attributes (CQA). This review highlighted about the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected and consistently manufacture the required product. Risk assessment tools and design of experiments are its prime components. This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. This article provides a complete data as well as the road map for universal implementation and application of QbD for pharmaceutical products. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Product design enhancement using apparent usability and affective quality.

PubMed

Seva, Rosemary R; Gosiaco, Katherine Grace T; Santos, Ma Crea Eurice D; Pangilinan, Denise Mae L

2011-03-01

In this study, apparent usability and affective quality were integrated in a design framework called the Usability Perception and Emotion Enhancement Model (UPEEM). The UPEEM was validated using structural equation modeling (SEM). The methodology consists of four phases namely product selection, attribute identification, design alternative generation, and design alternative evaluation. The first stage involved the selection of a product that highly involves the consumer. In the attribute identification stage, design elements of the product were identified. The possible values of these elements were also determined for use in the experimentation process. Design of experiments was used to identify how the attributes will be varied in the design alternative stage and which of the attributes significantly contribute to affective quality, apparent usability, and desirability in the design evaluation stage. Results suggest that product attributes related to form are relevant in eliciting intense affect and perception of usability in mobile phones especially those directly related to functionality and aesthetics. This study considered only four product attributes among so many due to the constraints of the research design employed. Attributes related to aesthetic perception of a product enhance apparent usability such as those related to dimensional ratios. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Study Quality in SLA: A Cumulative and Developmental Assessment of Designs, Analyses, Reporting Practices, and Outcomes in Quantitative L2 Research

ERIC Educational Resources Information Center

Plonsky, Luke

2011-01-01

I began this study with two assumptions. Assumption 1: Study quality matters. If the means by which researchers design, carry out, and report on their studies lack in rigor or transparency, theory and practice are likely to be misguided or at least decelerated. Assumption 2 is an implication of Assumption 1: Quality should be measured rather than…

Defining and improving quality management in Dutch diabetes care groups and outpatient clinics: design of the study

PubMed Central

2013-01-01

Background Worldwide, the organisation of diabetes care is changing. As a result general practices and diabetes teams in hospitals are becoming part of new organisations in which multidisciplinary care programs are implemented. In the Netherlands, 97 diabetes care groups and 104 outpatient clinics are working with a diabetes care program. Both types of organisations aim to improve the quality of diabetes care. Therefore, it is essential to understand the comprehensive elements needed for optimal quality management at organisational level. This study aims to assess the current level of diabetes quality management in both care groups and outpatient clinics and its improvement after providing feedback on their quality management system and tailored support. Methods/design This study is a before-after study with a one-year follow-up comparing the levels of quality management before and after an intervention to improve diabetes quality management. To assess the status of quality management, online questionnaires were developed based on current literature. They consist of six domains: organisation of care, multidisciplinary teamwork, patient centeredness, performance management, quality improvement policy and management strategies. Based on the questionnaires, respondents will receive feedback on their score in a radar diagram and an elucidating table. They will also be granted access to an online toolbox with instruments that proved to be effective in quality of care improvement and with practical examples. If requested, personal support in implementing these tools will be available. After one year quality management will be measured again using the same questionnaire. Discussion This study will reveal a nationwide picture of quality management in diabetes care groups and outpatient clinics in the Netherlands and evaluate the effect of offering tailored support. The operationalisation of quality management on organisational level may be of interest for other countries

Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design.

PubMed

Mathe, Nonsikelelo; Johnson, Steven T; Wozniak, Lisa A; Majumdar, Sumit R; Johnson, Jeffrey A

2015-08-25

Randomized controlled trials are considered the "gold standard" for scientific rigor in the assessment of benefits and harms of interventions in healthcare. They may not always be feasible, however, when evaluating quality improvement interventions in real-world healthcare settings. Non-randomized controlled trials (NCTs) are designed to answer questions of effectiveness of interventions in routine clinical practice to inform a decision or process. The on-off NCT design is a relatively new design where participant allocation is by alternation. In alternation, eligible patients are allocated to the intervention "on" or control "off " groups in time series dependent sequential clusters. We used two quality improvement studies undertaken in a Canadian primary care setting to illustrate the features of the on-off design. We also explored the perceptions and experiences of healthcare providers tasked with implementing the on-off study design. The on-off design successfully allocated patients to intervention and control groups. Imbalances between baseline variables were attributed to chance, with no detectable biases. However, healthcare providers' perspectives and experiences with the design in practice reveal some conflict. Specifically, providers described the process of allocating patients to the off group as unethical and immoral, feeling it was in direct conflict with their professional principle of providing care for all. The degree of dissatisfaction seemed exacerbated by: 1) the patient population involved (e.g., patient population viewed as high-risk (e.g., depressed or suicidal)), 2) conducting assessments without taking action (e.g., administering the PHQ-9 and not acting on the results), and 3) the (non-blinded) allocation process. Alternation, as in the on-off design, is a credible form of allocation. The conflict reported by healthcare providers in implementing the design, while not unique to the on-off design, may be alleviated by greater emphasis on

[Designing and implementation of a web-based quality monitoring system for plasma glucose measurement in multicenter population study].

PubMed

Liu, Yong; Wang, Limin; Pang, Richard; Mo, Nanxun; Hu, Yan; Deng, Qian; Hu, Zhaohui

2015-05-01

The aim of this paper is to describe the designing and implementation of a web-based plasma glucose measurement quality monitoring system to assess the analytical quality of plasma glucose measurements in multicenter population study and provide evidence for the future studies. In the chronic non-communicable disease and related factor surveillance in China, a web based quality monitoring system for plasma glucose measurement was established to conduct evaluation on plasma glucose monitoring quality and effectiveness in 302 surveillance centers, including quality control data entry, transmission and feedback. The majority of the surveillance centers met the quality requirements and passed the evaluation of reproducibility and precision of plasma glucose measurement, only a few centers required intensive training and re-assessment. In order to ensure the completeness and reliability of plasma glucose measurement in the surveillance centers, the establishment of web-based plasma glucose measurement quality control system can facilitate the identification of the qualified surveillance centers and evaluation of plasma glucose measurement quality in different regions. Communication and training are important in ensuring plasma glucose measurement quality. It is necessary to further improve this web-based plasma glucose measurement quality monitoring system in the future to reduce the method specific plasma glucose measurement bias.

Impact of longitudinal flying qualities upon the design of a transport with active controls

NASA Technical Reports Server (NTRS)

Sliwa, S. M.

1980-01-01

Direct constrained parameter optimization was used to optimally size a medium range transport for minimum direct operating cost. Several stability and control constraints were varied to study the sensitivity of the configuration to specifying the unaugmented flying qualities of transports designed with relaxed static stability. Additionally, a number of handling quality related design constants were studied with respect to their impact to the design.

A quality by design approach using artificial intelligence techniques to control the critical quality attributes of ramipril tablets manufactured by wet granulation.

PubMed

Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Özer, Özgen; Güneri, Tamer; York, Peter

2013-02-01

Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. This study was conducted in the framework of a QbD project involving ramipril tablets. Preliminary work included identification of the critical quality attributes (CQAs) and critical process parameters (CPPs) based on the quality target product profiles (QTPPs) using the historical data and risk assessment method failure mode and effect analysis (FMEA). Compendial and in-house specifications were selected as QTPPs for ramipril tablets. CPPs that affected the product and process were used to establish an experimental design. The results thus obtained can be used to facilitate definition of the design space using tools such as design of experiments (DoE), the response surface method (RSM) and artificial neural networks (ANNs). The project was aimed at discovering hidden knowledge associated with the manufacture of ramipril tablets using a range of artificial intelligence-based software, with the intention of establishing a multi-dimensional design space that ensures consistent product quality. At the end of the study, a design space was developed based on the study data and specifications, and a new formulation was optimized. On the basis of this formulation, a new laboratory batch formulation was prepared and tested. It was confirmed that the explored formulation was within the design space.

Evidence-based decision-making in infectious diseases epidemiology, prevention and control: matching research questions to study designs and quality appraisal tools.

PubMed

Harder, Thomas; Takla, Anja; Rehfuess, Eva; Sánchez-Vivar, Alex; Matysiak-Klose, Dorothea; Eckmanns, Tim; Krause, Gérard; de Carvalho Gomes, Helena; Jansen, Andreas; Ellis, Simon; Forland, Frode; James, Roberta; Meerpohl, Joerg J; Morgan, Antony; Schünemann, Holger; Zuiderent-Jerak, Teun; Wichmann, Ole

2014-05-21

The Project on a Framework for Rating Evidence in Public Health (PRECEPT) was initiated and is being funded by the European Centre for Disease Prevention and Control (ECDC) to define a methodology for evaluating and grading evidence and strength of recommendations in the field of public health, with emphasis on infectious disease epidemiology, prevention and control. One of the first steps was to review existing quality appraisal tools (QATs) for individual research studies of various designs relevant to this area, using a question-based approach. Through team discussions and expert consultations, we identified 20 relevant types of public health questions, which were grouped into six domains, i.e. characteristics of the pathogen, burden of disease, diagnosis, risk factors, intervention, and implementation of intervention. Previously published systematic reviews were used and supplemented by expert consultation to identify suitable QATs. Finally, a matrix was constructed for matching questions to study designs suitable to address them and respective QATs. Key features of each of the included QATs were then analyzed, in particular in respect to its intended use, types of questions and answers, presence/absence of a quality score, and if a validation was performed. In total we identified 21 QATs and 26 study designs, and matched them. Four QATs were suitable for experimental quantitative study designs, eleven for observational quantitative studies, two for qualitative studies, three for economic studies, one for diagnostic test accuracy studies, and one for animal studies. Included QATs consisted of six to 28 items. Six of the QATs had a summary quality score. Fourteen QATs had undergone at least one validation procedure. The results of this methodological study can be used as an inventory of potentially relevant questions, appropriate study designs and QATs for researchers and authorities engaged with evidence-based decision-making in infectious disease epidemiology

Evidence-based decision-making in infectious diseases epidemiology, prevention and control: matching research questions to study designs and quality appraisal tools

PubMed Central

2014-01-01

Background The Project on a Framework for Rating Evidence in Public Health (PRECEPT) was initiated and is being funded by the European Centre for Disease Prevention and Control (ECDC) to define a methodology for evaluating and grading evidence and strength of recommendations in the field of public health, with emphasis on infectious disease epidemiology, prevention and control. One of the first steps was to review existing quality appraisal tools (QATs) for individual research studies of various designs relevant to this area, using a question-based approach. Methods Through team discussions and expert consultations, we identified 20 relevant types of public health questions, which were grouped into six domains, i.e. characteristics of the pathogen, burden of disease, diagnosis, risk factors, intervention, and implementation of intervention. Previously published systematic reviews were used and supplemented by expert consultation to identify suitable QATs. Finally, a matrix was constructed for matching questions to study designs suitable to address them and respective QATs. Key features of each of the included QATs were then analyzed, in particular in respect to its intended use, types of questions and answers, presence/absence of a quality score, and if a validation was performed. Results In total we identified 21 QATs and 26 study designs, and matched them. Four QATs were suitable for experimental quantitative study designs, eleven for observational quantitative studies, two for qualitative studies, three for economic studies, one for diagnostic test accuracy studies, and one for animal studies. Included QATs consisted of six to 28 items. Six of the QATs had a summary quality score. Fourteen QATs had undergone at least one validation procedure. Conclusions The results of this methodological study can be used as an inventory of potentially relevant questions, appropriate study designs and QATs for researchers and authorities engaged with evidence-based decision

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

PubMed

Badawy, Sherif I F; Narang, Ajit S; LaMarche, Keirnan R; Subramanian, Ganeshkumar A; Varia, Sailesh A; Lin, Judy; Stevens, Tim; Shah, Pankaj A

2016-01-01

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product. Copyright © 2016. Published by Elsevier Inc.

77 FR 30087 - Air Quality Designations for the 2008 Ozone National Ambient Air Quality Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

...This rule establishes initial air quality designations for most areas in the United States, including areas of Indian country, for the 2008 primary and secondary national ambient air quality standards (NAAQS) for ozone. The designations for several counties in Illinois, Indiana, and Wisconsin that the EPA is considering for inclusion in the Chicago nonattainment area will be designated in a subsequent action, no later than May 31, 2012. Areas designated as nonattainment are also being classified by operation of law according to the severity of their air quality problems. The classification categories are Marginal, Moderate, Serious, Severe, and Extreme. The EPA is establishing the air quality thresholds that define the classifications in a separate rule that the EPA is signing and publishing in the Federal Register on the same schedule as these designations. In accordance with that separate rule, six nonattainment areas in California are being reclassified to a higher classification.

Co-designing for quality: Creating a user-driven tool to improve quality in youth mental health services.

PubMed

Hackett, Christina L; Mulvale, Gillian; Miatello, Ashleigh

2018-04-29

Although high quality mental health care for children and youth is a goal of many health systems, little is known about the dimensions of quality mental health care from users' perspectives. We engaged young people, caregivers and service providers to share experiences, which shed light on quality dimensions for youth mental health care. Using experience-based co-design, we collected qualitative data from young people aged 16-24 with a mental disorder (n = 19), identified caregivers (n = 12) and service providers (n = 14) about their experiences with respect to youth mental health services. Experience data were collected using multiple approaches including interviews, a suite of online and smartphone applications (n = 22), and a co-design event (n = 16) and analysed to extract touch points. These touch points were used to prioritize and co-design a user-driven prototype of a questionnaire to provide feedback to service providers. Young people, caregiver and service provider reports of service experiences were used to identify aspects of care quality at eight mental health service contact points: Access to mental health care; Transfer to/from hospital; Intake into hospital; Services provided; Assessment and treatment; Treatment environment; and Caregiver involvement in care. In some cases, low quality care was harmful to users and their caregivers. Young people co-designed a prototype of a user-driven feedback questionnaire to improve quality of service experiences that was supported by service providers and caregivers at the co-design event. By using EBCD to capture in-depth data regarding experiences of young people, their caregivers and service providers, study participants have begun to establish a baseline for acceptable quality of mental health care for young people. © 2018 The Authors. Health Expectations published by John Wiley & Sons Ltd.

Design Quality in the Context of Healthcare Environments: A Scoping Review

PubMed Central

Anåker, Anna; Heylighen, Ann; Nordin, Susanna; Elf, Marie

2016-01-01

Objective: We explored the concept of design quality in relation to healthcare environments. In addition, we present a taxonomy that illustrates the wide range of terms used in connection with design quality in healthcare. Background: High-quality physical environments can promote health and well-being. Developments in healthcare technology and methodology put high demands on the design quality of care environments, coupled with increasing expectations and demands from patients and staff that care environments be person centered, welcoming, and accessible while also supporting privacy and security. In addition, there are demands that decisions about the design of healthcare architecture be based on the best available information from credible research and the evaluation of existing building projects. Method: The basic principles of Arksey and O’Malley’s model of scoping review design were used. Data were derived from literature searches in scientific databases. A total of 18 articles and books were found that referred to design quality in a healthcare context. Results: Design quality of physical healthcare environments involves three different themes: (i) environmental sustainability and ecological values, (ii) social and cultural interactions and values, and (iii) resilience of the engineering and building construction. Design quality was clarified herein with a definition. Conclusions: Awareness of what is considered design quality in relation to healthcare architecture could help to design healthcare environments based on evidence. To operationalize the concept, its definition must be clear and explicit and able to meet the complex needs of the stakeholders in a healthcare context, including patients, staff, and significant others. PMID:28643560

Design Quality in the Context of Healthcare Environments: A Scoping Review.

PubMed

Anåker, Anna; Heylighen, Ann; Nordin, Susanna; Elf, Marie

2017-07-01

We explored the concept of design quality in relation to healthcare environments. In addition, we present a taxonomy that illustrates the wide range of terms used in connection with design quality in healthcare. High-quality physical environments can promote health and well-being. Developments in healthcare technology and methodology put high demands on the design quality of care environments, coupled with increasing expectations and demands from patients and staff that care environments be person centered, welcoming, and accessible while also supporting privacy and security. In addition, there are demands that decisions about the design of healthcare architecture be based on the best available information from credible research and the evaluation of existing building projects. The basic principles of Arksey and O'Malley's model of scoping review design were used. Data were derived from literature searches in scientific databases. A total of 18 articles and books were found that referred to design quality in a healthcare context. Design quality of physical healthcare environments involves three different themes: (i) environmental sustainability and ecological values, (ii) social and cultural interactions and values, and (iii) resilience of the engineering and building construction. Design quality was clarified herein with a definition. Awareness of what is considered design quality in relation to healthcare architecture could help to design healthcare environments based on evidence. To operationalize the concept, its definition must be clear and explicit and able to meet the complex needs of the stakeholders in a healthcare context, including patients, staff, and significant others.

Spectrum analysis on quality requirements consideration in software design documents.

PubMed

Kaiya, Haruhiko; Umemura, Masahiro; Ogata, Shinpei; Kaijiri, Kenji

2013-12-01

Software quality requirements defined in the requirements analysis stage should be implemented in the final products, such as source codes and system deployment. To guarantee this meta-requirement, quality requirements should be considered in the intermediate stages, such as the design stage or the architectural definition stage. We propose a novel method for checking whether quality requirements are considered in the design stage. In this method, a technique called "spectrum analysis for quality requirements" is applied not only to requirements specifications but also to design documents. The technique enables us to derive the spectrum of a document, and quality requirements considerations in the document are numerically represented in the spectrum. We can thus objectively identify whether the considerations of quality requirements in a requirements document are adapted to its design document. To validate the method, we applied it to commercial software systems with the help of a supporting tool, and we confirmed that the method worked well.

Quality by design case study: an integrated multivariate approach to drug product and process development.

PubMed

Huang, Jun; Kaul, Goldi; Cai, Chunsheng; Chatlapalli, Ramarao; Hernandez-Abad, Pedro; Ghosh, Krishnendu; Nagi, Arwinder

2009-12-01

To facilitate an in-depth process understanding, and offer opportunities for developing control strategies to ensure product quality, a combination of experimental design, optimization and multivariate techniques was integrated into the process development of a drug product. A process DOE was used to evaluate effects of the design factors on manufacturability and final product CQAs, and establish design space to ensure desired CQAs. Two types of analyses were performed to extract maximal information, DOE effect & response surface analysis and multivariate analysis (PCA and PLS). The DOE effect analysis was used to evaluate the interactions and effects of three design factors (water amount, wet massing time and lubrication time), on response variables (blend flow, compressibility and tablet dissolution). The design space was established by the combined use of DOE, optimization and multivariate analysis to ensure desired CQAs. Multivariate analysis of all variables from the DOE batches was conducted to study relationships between the variables and to evaluate the impact of material attributes/process parameters on manufacturability and final product CQAs. The integrated multivariate approach exemplifies application of QbD principles and tools to drug product and process development.

Office of Student Financial Aid Quality Improvement Program: Design and Implementation Plan.

ERIC Educational Resources Information Center

Advanced Technology, Inc., Reston, VA.

The purpose and direction of the Office of Student Financial Aid (OSFA) quality improvement program are described. The background and context for the Pell Grant quality control (QC) design study and the meaning of QC are reviewed. The general approach to quality improvement consists of the following elements: a strategic approach that enables OSFA…

Economic evaluation of flying-qualities design criteria for a transport configured with relaxed static stability

NASA Technical Reports Server (NTRS)

Sliwa, S. M.

1980-01-01

Direct constrained parameter optimization was used to optimally size a medium range transport for minimum direct operating cost. Several stability and control constraints were varied to study the sensitivity of the configuration to specifying the unaugmented flying qualities of transports designed to take maximum advantage of relaxed static stability augmentation systems. Additionally, a number of handling qualities related design constants were studied with respect to their impact on the design.

Design and implementation air quality monitoring robot

NASA Astrophysics Data System (ADS)

Chen, Yuanhua; Li, Jie; Qi, Chunxue

2017-01-01

Robot applied in environmental protection can break through the limitations in working environment, scope and mode of the existing environmental monitoring and pollution abatement equipments, which undertake the innovation and improvement in the basin, atmosphere, emergency and pollution treatment facilities. Actually, the relevant technology is backward with limited research and investment. Though the device companies have achieved some results in the study on the water quality monitoring, pipeline monitoring and sewage disposal, this technological progress on the whole is still much slow, and the mature product has not been formed. As a result, the market urges a demand of a new type of device which is more suitable for environmental protection on the basis of robot successfully applied in other fields. This paper designs and realizes a tracked mobile robot of air quality monitoring, which can be used to monitor air quality for the pollution accident in industrial parks and regular management.

Approach to design space from retrospective quality data.

PubMed

Puñal Peces, Daniel; García-Montoya, Encarna; Manich, Albert; Suñé-Negre, Josep Maria; Pérez-Lozano, Pilar; Miñarro, Montse; Ticó, Josep Ramon

2016-01-01

Nowadays, the entire manufacturing process is based on the current GMPs, which emphasize the reproducibility of the process, and companies have a lot of recorded data about their processes. The establishment of the design space (DS) from retrospective data for a wet compression process. A design of experiments (DoE) with historical data from 4 years of industrial production has been carried out using the experimental factors as the results of the previous risk analysis and eight key parameters (quality specifications) that encompassed process and quality control data. Software Statgraphics 5.0 was applied, and data were processed to obtain eight DS as well as their safe and working ranges. Experience shows that it is possible to determine DS retrospectively, being the greatest difficulty in handling and processing of high amounts of data; however, the practicality of this study is very interesting as it let have the DS with minimal investment in experiments since actual production batch data are processed statistically.

Pharmaceutical product development: A quality by design approach

PubMed Central

Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

Pharmaceutical product development: A quality by design approach.

PubMed

Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

Tailoring recombinant protein quality by rational media design.

PubMed

Brühlmann, David; Jordan, Martin; Hemberger, Jürgen; Sauer, Markus; Stettler, Matthieu; Broly, Hervé

2015-01-01

Clinical efficacy and safety of recombinant proteins are closely associated with their structural characteristics. The major quality attributes comprise glycosylation, charge variants (oxidation, deamidation, and C- & N-terminal modifications), aggregates, low-molecular-weight species (LMW), and misincorporation of amino acids in the protein backbone. Cell culture media design has a great potential to modulate these quality attributes due to the vital role of medium in mammalian cell culture. The purpose of this review is to provide an overview of the way both classical cell culture medium components and novel supplements affect the quality attributes of recombinant therapeutic proteins expressed in mammalian hosts, allowing rational and high-throughput optimization of mammalian cell culture media. A selection of specific and/or potent inhibitors and activators of oligosaccharide processing as well as components affecting multiple quality attributes are presented. Extensive research efforts in this field show the feasibility of quality engineering through media design, allowing to significantly modulate the protein function. © 2015 American Institute of Chemical Engineers.

The relationship between building design and residents' quality of life in extra care housing schemes.

PubMed

Orrell, Alison; McKee, Kevin; Torrington, Judith; Barnes, Sarah; Darton, Robin; Netten, Ann; Lewis, Alan

2013-05-01

Well-designed housing is recognised as being an important factor in promoting a good quality of life. Specialised housing models incorporating care services, such as extra care housing (ECH) schemes are seen as enabling older people to maintain a good quality of life despite increasing health problems that can accompany ageing. Despite the variation in ECH building design little is known about the impact of ECH building design on the quality of life of building users. The evaluation of older people's living environments (EVOLVE) study collected cross-sectional data on building design and quality of life in 23 ECH schemes in England, UK. Residents' quality of life was assessed using the schedule for the evaluation of individual quality of life-direct weighting (SEIQoL-DW) and on the four domains of control, autonomy, self-realisation and pleasure on the CASP-19. Building design was measured on 12 user-related domains by means of a new tool; the EVOLVE tool. Using multilevel linear regression, significant associations were found between several aspects of building design and quality of life. Furthermore, there was evidence that the relationship between building design and quality of life was partly mediated by the dependency of participants and scheme size (number of living units). Our findings suggest that good quality building design in ECH can support the quality of life of residents, but that designing features that support the needs of both relatively independent and frail users is problematic, with the needs of highly dependent users not currently supported as well as could be hoped by ECH schemes. Copyright © 2013 Elsevier Ltd. All rights reserved.

Water-quality assessment of part of the upper Mississippi River basin, Minnesota and Wisconsin: Design and implementation of water-quality studies, 1995-98

USGS Publications Warehouse

Stark, James R.; Fallon, J.D.; Fong, A.L.; Goldstein, R.M.; Hanson, P.E.; Kroening, S.E.; Lee, K.E.

1999-01-01

This report describes the design, site-selection, and implementation of the study. Methods used to collect, process, and analyze samples; characterize sites; and assess habitat are described. A comprehensive list of sample sites is provided. Sample analyses for water-quality studies included chlorophyll a, major inorganic constituents, nutrients, trace elements, tritium, radon, environmental isotopes, organic carbon, pesticides, volatile organic compounds, and other synthetic and naturallyoccurring organic compounds. Aquatic-biological samples included fish, benthic macroinvertebrates, and algal enumeration and identification, as well as synthetic-organic compounds and trace elements in fish tissue.

Taguchi Approach to Design Optimization for Quality and Cost: An Overview

NASA Technical Reports Server (NTRS)

Unal, Resit; Dean, Edwin B.

1990-01-01

Calibrations to existing cost of doing business in space indicate that to establish human presence on the Moon and Mars with the Space Exploration Initiative (SEI) will require resources, felt by many, to be more than the national budget can afford. In order for SEI to succeed, we must actually design and build space systems at lower cost this time, even with tremendous increases in quality and performance requirements, such as extremely high reliability. This implies that both government and industry must change the way they do business. Therefore, new philosophy and technology must be employed to design and produce reliable, high quality space systems at low cost. In recognizing the need to reduce cost and improve quality and productivity, Department of Defense (DoD) and National Aeronautics and Space Administration (NASA) have initiated Total Quality Management (TQM). TQM is a revolutionary management strategy in quality assurance and cost reduction. TQM requires complete management commitment, employee involvement, and use of statistical tools. The quality engineering methods of Dr. Taguchi, employing design of experiments (DOE), is one of the most important statistical tools of TQM for designing high quality systems at reduced cost. Taguchi methods provide an efficient and systematic way to optimize designs for performance, quality, and cost. Taguchi methods have been used successfully in Japan and the United States in designing reliable, high quality products at low cost in such areas as automobiles and consumer electronics. However, these methods are just beginning to see application in the aerospace industry. The purpose of this paper is to present an overview of the Taguchi methods for improving quality and reducing cost, describe the current state of applications and its role in identifying cost sensitive design parameters.

Defining process design space for a hydrophobic interaction chromatography (HIC) purification step: application of quality by design (QbD) principles.

PubMed

Jiang, Canping; Flansburg, Lisa; Ghose, Sanchayita; Jorjorian, Paul; Shukla, Abhinav A

2010-12-15

The concept of design space has been taking root under the quality by design paradigm as a foundation of in-process control strategies for biopharmaceutical manufacturing processes. This paper outlines the development of a design space for a hydrophobic interaction chromatography (HIC) process step. The design space included the impact of raw material lot-to-lot variability and variations in the feed stream from cell culture. A failure modes and effects analysis was employed as the basis for the process characterization exercise. During mapping of the process design space, the multi-dimensional combination of operational variables were studied to quantify the impact on process performance in terms of yield and product quality. Variability in resin hydrophobicity was found to have a significant influence on step yield and high-molecular weight aggregate clearance through the HIC step. A robust operating window was identified for this process step that enabled a higher step yield while ensuring acceptable product quality. © 2010 Wiley Periodicals, Inc.

Discrete State Change Model of Manufacturing Quality to Aid Assembly Process Design

NASA Astrophysics Data System (ADS)

Koga, Tsuyoshi; Aoyama, Kazuhiro

This paper proposes a representation model of the quality state change in an assembly process that can be used in a computer-aided process design system. In order to formalize the state change of the manufacturing quality in the assembly process, the functions, operations, and quality changes in the assembly process are represented as a network model that can simulate discrete events. This paper also develops a design method for the assembly process. The design method calculates the space of quality state change and outputs a better assembly process (better operations and better sequences) that can be used to obtain the intended quality state of the final product. A computational redesigning algorithm of the assembly process that considers the manufacturing quality is developed. The proposed method can be used to design an improved manufacturing process by simulating the quality state change. A prototype system for planning an assembly process is implemented and applied to the design of an auto-breaker assembly process. The result of the design example indicates that the proposed assembly process planning method outputs a better manufacturing scenario based on the simulation of the quality state change.

Analytical quality by design: a tool for regulatory flexibility and robust analytics.

PubMed

Peraman, Ramalingam; Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

2015-01-01

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

PubMed Central

Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

2015-01-01

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT). PMID:25722723

Relation between experimental and non-experimental study designs. HB vaccines: a case study

PubMed Central

Jefferson, T.; Demicheli, V.

1999-01-01

STUDY OBJECTIVE: To examine the relation between experimental and non- experimental study design in vaccinology. DESIGN: Assessment of each study design's capability of testing four aspects of vaccine performance, namely immunogenicity (the capacity to stimulate the immune system), duration of immunity conferred, incidence and seriousness of side effects, and number of infections prevented by vaccination. SETTING: Experimental and non-experimental studies on hepatitis B (HB) vaccines in the Cochrane Vaccines Field Database. RESULTS: Experimental and non-experimental vaccine study designs are frequently complementary but some aspects of vaccine quality can only be assessed by one of the types of study. More work needs to be done on the relation between study quality and its significance in terms of effect size.   PMID:10326054

Considerations of study design.

PubMed

Koretz, Ronald L

2007-12-01

Research projects attempt to answer specific questions. The particular study design that is selected will depend in large measure on the nature of the question and the time and resources available. There are 5 common categories of clinical questions; they relate to etiology, prognosis, utility of diagnostic tests, efficacy of proposed interventions, and cost of treatment in specific disease states. A number of study designs can be used. Case reports serve to memorialize unusual or novel aspects of diseases. Retrospective case series are useful for defining natural history. Case-control studies are used by epidemiologists to elucidate potential etiologies of diseases. Prospective cohort studies can be used to assess natural history or to assess potential disease etiologies. Controlled trials are designed to assess the efficacy of therapeutic interventions. Studies that define the sensitivity and specificity of diagnostic tests can be used to assess the utility of those tests. Economic analyses estimate the costs that particular diseases or therapies will require. Each of these study designs has limitations; with the exception of high-quality randomized trials, none of these study designs can establish a causative relationship between putative etiologic (or therapeutic) factors and disease (outcomes).

Pharmaceutical quality by design: product and process development, understanding, and control.

PubMed

Yu, Lawrence X

2008-04-01

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

Quality-control design for surface-water sampling in the National Water-Quality Network

USGS Publications Warehouse

Riskin, Melissa L.; Reutter, David C.; Martin, Jeffrey D.; Mueller, David K.

2018-04-10

The data-quality objectives for samples collected at surface-water sites in the National Water-Quality Network include estimating the extent to which contamination, matrix effects, and measurement variability affect interpretation of environmental conditions. Quality-control samples provide insight into how well the samples collected at surface-water sites represent the true environmental conditions. Quality-control samples used in this program include field blanks, replicates, and field matrix spikes. This report describes the design for collection of these quality-control samples and the data management needed to properly identify these samples in the U.S. Geological Survey’s national database.

Implementation of quality by design approach in manufacturing process optimization of dry granulated, immediate release, coated tablets - a case study.

PubMed

Teżyk, Michał; Jakubowska, Emilia; Milanowski, Bartłomiej; Lulek, Janina

2017-10-01

The aim of this study was to optimize the process of tablets compression and identification of film-coating critical process parameters (CPPs) affecting critical quality attributes (CQAs) using quality by design (QbD) approach. Design of experiment (DOE) and regression methods were employed to investigate hardness, disintegration time, and thickness of uncoated tablets depending on slugging and tableting compression force (CPPs). Plackett-Burman experimental design was applied to identify critical coating process parameters among selected ones that is: drying and preheating time, atomization air pressure, spray rate, air volume, inlet air temperature, and drum pressure that may influence the hardness and disintegration time of coated tablets. As a result of the research, design space was established to facilitate an in-depth understanding of existing relationship between CPPs and CQAs of intermediate product (uncoated tablets). Screening revealed that spray rate and inlet air temperature are two most important factors that affect the hardness of coated tablets. Simultaneously, none of the tested coating factors have influence on disintegration time. The observation was confirmed by conducting film coating of pilot size batches.

A systematic and transparent approach for assessing the methodological quality of intervention effectiveness research: the Study Design and Implementation Assessment Device (Study DIAD).

PubMed

Valentine, Jeffrey C; Cooper, Harris

2008-06-01

Assessments of studies meant to evaluate the effectiveness of interventions, programs, and policies can serve an important role in the interpretation of research results. However, evidence suggests that available quality assessment tools have poor measurement characteristics and can lead to opposing conclusions when applied to the same body of studies. These tools tend to (a) be insufficiently operational, (b) rely on arbitrary post-hoc decision rules, and (c) result in a single number to represent a multidimensional construct. In response to these limitations, a multilevel and hierarchical instrument was developed in consultation with a wide range of methodological and statistical experts. The instrument focuses on the operational details of studies and results in a profile of scores instead of a single score to represent study quality. A pilot test suggested that satisfactory between-judge agreement can be obtained using well-trained raters working in naturalistic conditions. Limitations of the instrument are discussed, but these are inherent in making decisions about study quality given incomplete reporting and in the absence of strong, contextually based information about the effects of design flaws on study outcomes. (PsycINFO Database Record (c) 2008 APA, all rights reserved).

Quality cell therapy manufacturing by design.

PubMed

Lipsitz, Yonatan Y; Timmins, Nicholas E; Zandstra, Peter W

2016-04-01

Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies. We argue here that a solution to this challenge is to design cell manufacturing processes according to quality-by-design (QbD) principles. QbD integrates scientific knowledge and risk analysis into manufacturing process development and is already being adopted by the biopharmaceutical industry. Many opportunities to incorporate QbD into cell therapy manufacturing exist, although further technology development is required for full implementation. Linking measurable molecular and cellular characteristics of a cell population to final product quality through QbD is a crucial step in realizing the potential for cell therapies to transform healthcare.

A quality by design approach to optimization of emulsions for electrospinning using factorial and D-optimal designs.

PubMed

Badawi, Mariam A; El-Khordagui, Labiba K

2014-07-16

Emulsion electrospinning is a multifactorial process used to generate nanofibers loaded with hydrophilic drugs or macromolecules for diverse biomedical applications. Emulsion electrospinnability is greatly impacted by the emulsion pharmaceutical attributes. The aim of this study was to apply a quality by design (QbD) approach based on design of experiments as a risk-based proactive approach to achieve predictable critical quality attributes (CQAs) in w/o emulsions for electrospinning. Polycaprolactone (PCL)-thickened w/o emulsions containing doxycycline HCl were formulated using a Span 60/sodium lauryl sulfate (SLS) emulsifier blend. The identified emulsion CQAs (stability, viscosity and conductivity) were linked with electrospinnability using a 3(3) factorial design to optimize emulsion composition for phase stability and a D-optimal design to optimize stable emulsions for viscosity and conductivity after shifting the design space. The three independent variables, emulsifier blend composition, organic:aqueous phase ratio and polymer concentration, had a significant effect (p<0.05) on emulsion CQAs, the emulsifier blend composition exerting prominent main and interaction effects. Scanning electron microscopy (SEM) of emulsion-electrospun NFs and desirability functions allowed modeling of emulsion CQAs to predict electrospinnable formulations. A QbD approach successfully built quality in electrospinnable emulsions, allowing development of hydrophilic drug-loaded nanofibers with desired morphological characteristics. Copyright © 2014 Elsevier B.V. All rights reserved.

Quality by Design approach for studying the impact of formulation and process variables on product quality of oral disintegrating films.

PubMed

Mazumder, Sonal; Pavurala, Naresh; Manda, Prashanth; Xu, Xiaoming; Cruz, Celia N; Krishnaiah, Yellela S R

2017-07-15

The present investigation was carried out to understand the impact of formulation and process variables on the quality of oral disintegrating films (ODF) using Quality by Design (QbD) approach. Lamotrigine (LMT) was used as a model drug. Formulation variable was plasticizer to film former ratio and process variables were drying temperature, air flow rate in the drying chamber, drying time and wet coat thickness of the film. A Definitive Screening Design of Experiments (DoE) was used to identify and classify the critical formulation and process variables impacting critical quality attributes (CQA). A total of 14 laboratory-scale DoE formulations were prepared and evaluated for mechanical properties (%elongation at break, yield stress, Young's modulus, folding endurance) and other CQA (dry thickness, disintegration time, dissolution rate, moisture content, moisture uptake, drug assay and drug content uniformity). The main factors affecting mechanical properties were plasticizer to film former ratio and drying temperature. Dissolution rate was found to be sensitive to air flow rate during drying and plasticizer to film former ratio. Data were analyzed for elucidating interactions between different variables, rank ordering the critical materials attributes (CMA) and critical process parameters (CPP), and for providing a predictive model for the process. Results suggested that plasticizer to film former ratio and process controls on drying are critical to manufacture LMT ODF with the desired CQA. Published by Elsevier B.V.

Implementation of Quality by Design for Formulation of Rebamipide Gastro-retentive Tablet.

PubMed

Ha, Jung-Myung; Seo, Jeong-Woong; Kim, Su-Hyeon; Kim, Ju-Young; Park, Chun-Woong; Rhee, Yun-Seok; Park, Eun-Seok

2017-11-01

The purpose of the present study was to develop a rebamipide (RBM) gastro-retentive (GR) tablet by implementing quality by design (QbD). RBM GR tablets were prepared using a sublimation method. Quality target product profile (QTPP) and critical quality attributes (CQAs) of the RBM GR tablets were defined according to the preliminary studies. Factors affecting the CQAs were prioritized using failure mode and effects analysis (FMEA). Design space and optimum formulation were established through a mixture design. The validity of the design space was confirmed using runs within the area. The QTPP of the RBM GR tablets was the orally administered GR tablet containing 300 mg of RBM taken once daily. Based on the QTPP, dissolution rate, tablet friability, and floating property were chosen as CQAs. According to the risk assessment, the amount of sustained-release agent, sublimating material, and diluent showed high-risk priority number (RPN) values above 40. Based on the RPN, these factors were further investigated using mixture design methodology. Design space of formulations was depicted as an overlaid contour plot and the optimum formulation to satisfy the desired responses was obtained by determining the expected value of each response. The similarity factor (f2) of the release profile between predicted response and experimental response was 89.463, suggesting that two release profiles are similar. The validity of the design space was also confirmed. Consequently, we were able to develop the RBM GR tablets by implementing the QbD concept. These results provide useful information for development of tablet formulations using the QbD.

Children's Health and Indoor Air Quality in Primary Schools and Homes in Portugal-Study Design.

PubMed

Madureira, Joana; Paciência, Inês; Ramos, Elisabete; Barros, Henrique; Pereira, Cristiana; Teixeira, João Paulo; Fernandes, Eduardo de Oliveira

2015-01-01

The main aim of the research project "On the Contribution of Schools to Children's Overall Indoor Air Exposure" is to study associations between adverse health effects, namely, allergy, asthma, and respiratory symptoms, and indoor air pollutants to which children are exposed to in primary schools and homes. Specifically, this investigation reports on the design of the study and methods used for data collection within the research project and discusses factors that need to be considered when designing such a study. Further, preliminary findings concerning descriptors of selected characteristics in schools and homes, the study population, and clinical examination are presented. The research project was designed in two phases. In the first phase, 20 public primary schools were selected and a detailed inspection and indoor air quality (IAQ) measurements including volatile organic compounds (VOC), aldehydes, particulate matter (PM2.5, PM10), carbon dioxide (CO2), carbon monoxide (CO), bacteria, fungi, temperature, and relative humidity were conducted. A questionnaire survey of 1600 children of ages 8-9 years was undertaken and a lung function test, exhaled nitric oxide (eNO), and tear film stability testing were performed. The questionnaire focused on children's health and on the environment in their school and homes. One thousand and ninety-nine questionnaires were returned. In the second phase, a subsample of 68 children was enrolled for further studies, including a walk-through inspection and checklist and an extensive set of IAQ measurements in their homes. The acquired data are relevant to assess children's environmental exposures and health status.

Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control.

PubMed

Westgard, James O; Westgard, Sten A

2017-03-01

Six sigma concepts provide a quality management system (QMS) with many useful tools for managing quality in medical laboratories. This Six Sigma QMS is driven by the quality required for the intended use of a test. The most useful form for this quality requirement is the allowable total error. Calculation of a sigma-metric provides the best predictor of risk for an analytical examination process, as well as a design parameter for selecting the statistical quality control (SQC) procedure necessary to detect medically important errors. Simple point estimates of sigma at medical decision concentrations are sufficient for laboratory applications. Copyright © 2016 Elsevier Inc. All rights reserved.

Evidence-Based Design Features Improve Sleep Quality Among Psychiatric Inpatients.

PubMed

Pyrke, Ryan J L; McKinnon, Margaret C; McNeely, Heather E; Ahern, Catherine; Langstaff, Karen L; Bieling, Peter J

2017-10-01

The primary aim of the present study was to compare sleep characteristics pre- and post-move into a state-of-the-art mental health facility, which offered private sleeping quarters. Significant evidence points toward sleep disruption among psychiatric inpatients. It is unclear, however, how environmental factors (e.g., dorm-style rooms) impact sleep quality in this population. To assess sleep quality, a novel objective technology, actigraphy, was used before and after a facility move. Subjective daily interviews were also administered, along with the Horne-Ostberg Morningness-Eveningness Questionnaire and the Pittsburgh Sleep Quality Index. Actigraphy revealed significant improvements in objective sleep quality following the facility move. Interestingly, subjective report of sleep quality did not correlate with the objective measures. Circadian sleep type appeared to play a role in influencing subjective attitudes toward sleep quality. Built environment has a significant effect on the sleep quality of psychiatric inpatients. Given well-documented disruptions in sleep quality present among psychiatric patients undergoing hospitalization, design elements like single patient bedrooms are highly desirable.

Relation between experimental and non-experimental study designs. HB vaccines: a case study.

PubMed

Jefferson, T; Demicheli, V

1999-01-01

To examine the relation between experimental and non-experimental study design in vaccinology. Assessment of each study design's capability of testing four aspects of vaccine performance, namely immunogenicity (the capacity to stimulate the immune system), duration of immunity conferred, incidence and seriousness of side effects, and number of infections prevented by vaccination. Experimental and non-experimental studies on hepatitis B (HB) vaccines in the Cochrane Vaccines Field Database. Experimental and non-experimental vaccine study designs are frequently complementary but some aspects of vaccine quality can only be assessed by one of the types of study. More work needs to be done on the relation between study quality and its significance in terms of effect size.

The Incorporation of Quality Attributes into Online Course Design in Higher Education

ERIC Educational Resources Information Center

Lenert, Kathleen Anne; Diane P. Janes

2017-01-01

A survey was designed incorporating questions on 28 attributes (compiled through a literature review) and considered to be quality features in online academic courses in higher education. This study sought to investigate the ongoing practice of instructional designers and instructors in the United States with respect to their incorporation of…

78 FR 47191 - Air Quality Designations for the 2010 Sulfur Dioxide (SO2) Primary National Ambient Air Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

... Air Quality Designations for the 2010 Sulfur Dioxide (SO[bdi2]) Primary National Ambient Air Quality... air quality designations for certain areas in the United States for the 2010 primary Sulfur Dioxide... of this document? III. What is sulfur dioxide? IV. What is the 2010 SO 2 NAAQS and what are the...

Re-conceiving building design quality: A review of building users in their social context.

PubMed

Watson, Kelly J; Evans, James; Karvonen, Andrew; Whitley, Tim

2016-05-01

Considerable overlap exists between post-occupancy research evaluating building design quality and the concept of 'social value', popularised by its recent application to issues of the public realm. To outline this potential research agenda, the paper reviews design quality research on buildings in relation to users and their social context where the term 'social context' refers to building user group dynamics, a combination of organisational cultures, management strategies, and social norms and practices. The review is conducted across five key building types, namely housing, workplaces, healthcare, education, and the retail/service sector. Research commonalities and gaps are identified in order to build a more comprehensive picture of the design quality literature and its handling of users in their social context. The key findings concerning each building type are presented visually. It is concluded that the design quality field comprises a patchwork of relatively isolated studies of various building types, with significant potential for theoretical and empirical development through interdisciplinary collaboration. Users tend to be conceived as anonymous and autonomous individuals with little analysis of user identity or interaction. Further, the contextual impact of user group dynamics on the relationship between building design and building user is rarely addressed in the literature. Producing a more nuanced understanding of users in situ is proposed as an important area for future design quality research.

Re-conceiving building design quality: A review of building users in their social context

PubMed Central

Evans, James; Karvonen, Andrew; Whitley, Tim

2014-01-01

Considerable overlap exists between post-occupancy research evaluating building design quality and the concept of ‘social value’, popularised by its recent application to issues of the public realm. To outline this potential research agenda, the paper reviews design quality research on buildings in relation to users and their social context where the term ‘social context’ refers to building user group dynamics, a combination of organisational cultures, management strategies, and social norms and practices. The review is conducted across five key building types, namely housing, workplaces, healthcare, education, and the retail/service sector. Research commonalities and gaps are identified in order to build a more comprehensive picture of the design quality literature and its handling of users in their social context. The key findings concerning each building type are presented visually. It is concluded that the design quality field comprises a patchwork of relatively isolated studies of various building types, with significant potential for theoretical and empirical development through interdisciplinary collaboration. Users tend to be conceived as anonymous and autonomous individuals with little analysis of user identity or interaction. Further, the contextual impact of user group dynamics on the relationship between building design and building user is rarely addressed in the literature. Producing a more nuanced understanding of users in situ is proposed as an important area for future design quality research. PMID:27110217

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space.

PubMed

Eon-duval, Alex; Valax, Pascal; Solacroup, Thomas; Broly, Hervé; Gleixner, Ralf; Strat, Claire L E; Sutter, James

2012-10-01

The article describes how Quality by Design principles can be applied to the drug substance manufacturing process of an Fc fusion protein. First, the quality attributes of the product were evaluated for their potential impact on safety and efficacy using risk management tools. Similarly, process parameters that have a potential impact on critical quality attributes (CQAs) were also identified through a risk assessment. Critical process parameters were then evaluated for their impact on CQAs, individually and in interaction with each other, using multivariate design of experiment techniques during the process characterisation phase. The global multi-step Design Space, defining operational limits for the entire drug substance manufacturing process so as to ensure that the drug substance quality targets are met, was devised using predictive statistical models developed during the characterisation study. The validity of the global multi-step Design Space was then confirmed by performing the entire process, from cell bank thawing to final drug substance, at its limits during the robustness study: the quality of the final drug substance produced under different conditions was verified against predefined targets. An adaptive strategy was devised whereby the Design Space can be adjusted to the quality of the input material to ensure reliable drug substance quality. Finally, all the data obtained during the process described above, together with data generated during additional validation studies as well as manufacturing data, were used to define the control strategy for the drug substance manufacturing process using a risk assessment methodology. Copyright © 2012 Wiley-Liss, Inc.

Application of quality by design for 3D printed bone prostheses and scaffolds

PubMed Central

Martinez-Marquez, Daniel; Mirnajafizadeh, Ali; Carty, Christopher P.

2018-01-01

3D printing is an emergent manufacturing technology recently being applied in the medical field for the development of custom bone prostheses and scaffolds. However, successful industry transformation to this new design and manufacturing approach requires technology integration, concurrent multi-disciplinary collaboration, and a robust quality management framework. This latter change enabler is the focus of this study. While a number of comprehensive quality frameworks have been developed in recent decades to ensure that the manufacturing of medical devices produces reliable products, they are centred on the traditional context of standardised manufacturing techniques. The advent of 3D printing technologies and the prospects for mass customisation provides significant market opportunities, but also presents a serious challenge to regulatory bodies tasked with managing and assuring product quality and safety. Before 3D printing bone prostheses and scaffolds can gain traction, industry stakeholders, such as regulators, clients, medical practitioners, insurers, lawyers, and manufacturers, would all require a high degree of confidence that customised manufacturing can achieve the same quality outcomes as standardised manufacturing. A Quality by Design (QbD) approach to custom 3D printed prostheses can help to ensure that products are designed and manufactured correctly from the beginning without errors. This paper reports on the adaptation of the QbD approach for the development process of 3D printed custom bone prosthesis and scaffolds. This was achieved through the identification of the Critical Quality Attributes of such products, and an extensive review of different design and fabrication methods for 3D printed bone prostheses. Research outcomes include the development of a comprehensive design and fabrication process flow diagram, and categorised risks associated with the design and fabrication processes of such products. An extensive systematic literature review

Application of quality by design for 3D printed bone prostheses and scaffolds.

PubMed

Martinez-Marquez, Daniel; Mirnajafizadeh, Ali; Carty, Christopher P; Stewart, Rodney A

2018-01-01

3D printing is an emergent manufacturing technology recently being applied in the medical field for the development of custom bone prostheses and scaffolds. However, successful industry transformation to this new design and manufacturing approach requires technology integration, concurrent multi-disciplinary collaboration, and a robust quality management framework. This latter change enabler is the focus of this study. While a number of comprehensive quality frameworks have been developed in recent decades to ensure that the manufacturing of medical devices produces reliable products, they are centred on the traditional context of standardised manufacturing techniques. The advent of 3D printing technologies and the prospects for mass customisation provides significant market opportunities, but also presents a serious challenge to regulatory bodies tasked with managing and assuring product quality and safety. Before 3D printing bone prostheses and scaffolds can gain traction, industry stakeholders, such as regulators, clients, medical practitioners, insurers, lawyers, and manufacturers, would all require a high degree of confidence that customised manufacturing can achieve the same quality outcomes as standardised manufacturing. A Quality by Design (QbD) approach to custom 3D printed prostheses can help to ensure that products are designed and manufactured correctly from the beginning without errors. This paper reports on the adaptation of the QbD approach for the development process of 3D printed custom bone prosthesis and scaffolds. This was achieved through the identification of the Critical Quality Attributes of such products, and an extensive review of different design and fabrication methods for 3D printed bone prostheses. Research outcomes include the development of a comprehensive design and fabrication process flow diagram, and categorised risks associated with the design and fabrication processes of such products. An extensive systematic literature review

Designing image segmentation studies: Statistical power, sample size and reference standard quality.

PubMed

Gibson, Eli; Hu, Yipeng; Huisman, Henkjan J; Barratt, Dean C

2017-12-01

Segmentation algorithms are typically evaluated by comparison to an accepted reference standard. The cost of generating accurate reference standards for medical image segmentation can be substantial. Since the study cost and the likelihood of detecting a clinically meaningful difference in accuracy both depend on the size and on the quality of the study reference standard, balancing these trade-offs supports the efficient use of research resources. In this work, we derive a statistical power calculation that enables researchers to estimate the appropriate sample size to detect clinically meaningful differences in segmentation accuracy (i.e. the proportion of voxels matching the reference standard) between two algorithms. Furthermore, we derive a formula to relate reference standard errors to their effect on the sample sizes of studies using lower-quality (but potentially more affordable and practically available) reference standards. The accuracy of the derived sample size formula was estimated through Monte Carlo simulation, demonstrating, with 95% confidence, a predicted statistical power within 4% of simulated values across a range of model parameters. This corresponds to sample size errors of less than 4 subjects and errors in the detectable accuracy difference less than 0.6%. The applicability of the formula to real-world data was assessed using bootstrap resampling simulations for pairs of algorithms from the PROMISE12 prostate MR segmentation challenge data set. The model predicted the simulated power for the majority of algorithm pairs within 4% for simulated experiments using a high-quality reference standard and within 6% for simulated experiments using a low-quality reference standard. A case study, also based on the PROMISE12 data, illustrates using the formulae to evaluate whether to use a lower-quality reference standard in a prostate segmentation study. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Implementation of "Quality by Design (QbD)" Approach for the Development of 5-Fluorouracil Loaded Thermosensitive Hydrogel.

PubMed

Dalwadi, Chintan; Patel, Gayatri

2016-01-01

The purpose of this study was to investigate Quality by Design (QbD) principle for the preparation of hydrogel products to prove both practicability and utility of executing QbD concept to hydrogel based controlled release systems. Product and process understanding will help in decreasing the variability of critical material and process parameters, which give quality product output and reduce the risk. This study includes the identification of the Quality Target Product Profiles (QTPPs) and Critical Quality Attributes (CQAs) from literature or preliminary studies. To identify and control the variability in process and material attributes, two tools of QbD was utilized, Quality Risk Management (QRM) and Experimental Design. Further, it helps to identify the effect of these attributes on CQAs. Potential risk factors were identified from fishbone diagram and screened by risk assessment and optimized by 3-level 2- factor experimental design with center points in triplicate, to analyze the precision of the target process. This optimized formulation was further characterized by gelling time, gelling temperature, rheological parameters, in-vitro biodegradation and in-vitro drug release. Design space was created using experimental design tool that gives the control space and working within this controlled space reduces all the failure modes below the risk level. In conclusion, QbD approach with QRM tool provides potent and effectual pyramid to enhance the quality into the hydrogel.

Air quality considerations for stormwater green street design.

PubMed

Shaneyfelt, Kathryn M; Anderson, Andrew R; Kumar, Prashant; Hunt, William F

2017-12-01

Green streets are increasingly being used as a stormwater management strategy to mitigate stormwater runoff at its source while providing other environmental and societal benefits, including connecting pedestrians to the street. Simultaneously, human exposure to particulate matter from urban transportation is of major concern worldwide due to the proximity of pedestrians, drivers, and cyclists to the emission sources. Vegetation used for stormwater treatment can help designers limit the exposure of people to air pollutants. This goal can be achieved through the deliberate placement of green streets, along with strategic planting schemes that maximize pollutant dispersion. This communication presents general design considerations for green streets that combine stormwater management and air quality goals. There is currently limited guidance on designing green streets for air quality considerations; this is the first communication to offer suggestions and advice for the design of green stormwater streets in regards to their effects on air quality. Street characteristics including (1) the width to height ratio of the street to the buildings, (2) the type of trees and their location, and (3) any prevailing winds can have an impact on pollutant concentrations within the street and along sidewalks. Vegetation within stormwater control measures has the ability to reduce particulate matter concentrations; however, it must be carefully selected and placed within the green street to promote the dispersion of air flow. Copyright © 2017 Elsevier Ltd. All rights reserved.

Enhancing mathematics teachers' quality through Lesson Study.

PubMed

Lomibao, Laila S

2016-01-01

The efficiency and effectivity of the learning experience is dependent on the teacher quality, thus, enhancing teacher's quality is vital in improving the students learning outcome. Since, the usual top-down one-shot cascading model practice for teachers' professional development in Philippines has been observed to have much information dilution, and the Southeast Asian Ministers of Education Organization demanded the need to develop mathematics teachers' quality standards through the Southeast Asia Regional Standards for Mathematics Teachers (SEARS-MT), thus, an intensive, ongoing professional development model should be provided to teachers. This study was undertaken to determine the impact of Lesson Study on Bulua National High School mathematics teachers' quality level in terms of SEARS-MT dimensions. A mixed method of quantitative-qualitative research design was employed. Results of the analysis revealed that Lesson Study effectively enhanced mathematics teachers' quality and promoted teachers professional development. Teachers positively perceived Lesson Study to be beneficial for them to become a better mathematics teacher.

Taguchi experimental design to determine the taste quality characteristic of candied carrot

NASA Astrophysics Data System (ADS)

Ekawati, Y.; Hapsari, A. A.

2018-03-01

Robust parameter design is used to design product that is robust to noise factors so the product’s performance fits the target and delivers a better quality. In the process of designing and developing the innovative product of candied carrot, robust parameter design is carried out using Taguchi Method. The method is used to determine an optimal quality design. The optimal quality design is based on the process and the composition of product ingredients that are in accordance with consumer needs and requirements. According to the identification of consumer needs from the previous research, quality dimensions that need to be assessed are the taste and texture of the product. The quality dimension assessed in this research is limited to the taste dimension. Organoleptic testing is used for this assessment, specifically hedonic testing that makes assessment based on consumer preferences. The data processing uses mean and signal to noise ratio calculation and optimal level setting to determine the optimal process/composition of product ingredients. The optimal value is analyzed using confirmation experiments to prove that proposed product match consumer needs and requirements. The result of this research is identification of factors that affect the product taste and the optimal quality of product according to Taguchi Method.

[Quality by design approaches for pharmaceutical development and manufacturing of Chinese medicine].

PubMed

Xu, Bing; Shi, Xin-Yuan; Wu, Zhi-Sheng; Zhang, Yan-Ling; Wang, Yun; Qiao, Yan-Jiang

2017-03-01

The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory. The holistic design aims at constructing both the quality problem space from the patient requirement and the quality solution space from multidisciplinary knowledge. Holistic information analysis emphasizes understanding the quality pattern of Chinese medicine by integrating and mining multisource data and information at a relatively high level. The batch-to-batch quality consistence and manufacturing system reliability can be realized by comprehensive application of inspective quality control, statistical quality control, predictive quality control and intelligent quality control strategies. Holistic process optimization is to improve the product quality and process capability during the product lifecycle management. The implementation of QbD is useful to eliminate the ecosystem contradictions lying in the pharmaceutical development and manufacturing process of Chinese medicine product, and helps guarantee the cost effectiveness. Copyright© by the Chinese Pharmaceutical Association.

Flared landing approach flying qualities. Volume 1: Experiment design and analysis

NASA Technical Reports Server (NTRS)

Weingarten, Norman C.; Berthe, Charles J., Jr.; Rynaski, Edmund G.; Sarrafian, Shahan K.

1986-01-01

An inflight research study was conducted utilizing the USAF Total Inflight Simulator (TIFS) to investigate longitudinal flying qualities for the flared landing approach phase of flight. The purpose of the experiment was to generate a consistent set of data for: (1) determining what kind of commanded response the pilot prefers in order to flare and land an airplane with precision, and (2) refining a time history criterion that took into account all the necessary variables and their characteristics that would accurately predict flying qualities. The result of the first part provides guidelines to the flight control system designer, using MIL-F-8785-(C) as a guide, that yield the dynamic behavior pilots perfer in flared landings. The results of the second part provides the flying qualities engineer with a newly derived flying qualities predictive tool which appears to be highly accurate. This time domain predictive flying qualities criterion was applied to the flight data as well as six previous flying qualities studies, and the results indicate that the criterion predicted the flying qualities level 81% of the time and the Cooper-Harper pilot rating, within + or - 1, 60% of the time.

Design of agricultural product quality safety retrospective supervision system of Jiangsu province

NASA Astrophysics Data System (ADS)

Wang, Kun

2017-08-01

In store and supermarkets to consumers can trace back agricultural products through the electronic province card to query their origin, planting, processing, packaging, testing and other important information and found that the problems. Quality and safety issues can identify the responsibility of the problem. This paper designs a retroactive supervision system for the quality and safety of agricultural products in Jiangsu Province. Based on the analysis of agricultural production and business process, the goal of Jiangsu agricultural product quality safety traceability system construction is established, and the specific functional requirements and non-functioning requirements of the retroactive system are analyzed, and the target is specified for the specific construction of the retroactive system. The design of the quality and safety traceability system in Jiangsu province contains the design of the overall design, the trace code design and the system function module.

Understanding Quality Assurance: A Cross Country Case Study

ERIC Educational Resources Information Center

Choon Boey Lim, Fion

2008-01-01

Purpose: The purpose of this paper is to examine the level of understanding between an Australian university and its offshore partner institution, on quality assurance. It attempts to highlight the dynamics of quality assurance policy implementation within and across institutions for an offshore degree. Design/methodology/approach: The study used…

Quality by design approach: application of artificial intelligence techniques of tablets manufactured by direct compression.

PubMed

Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Ozer, Ozgen; Güneri, Tamer; York, Peter

2012-12-01

The publication of the International Conference of Harmonization (ICH) Q8, Q9, and Q10 guidelines paved the way for the standardization of quality after the Food and Drug Administration issued current Good Manufacturing Practices guidelines in 2003. "Quality by Design", mentioned in the ICH Q8 guideline, offers a better scientific understanding of critical process and product qualities using knowledge obtained during the life cycle of a product. In this scope, the "knowledge space" is a summary of all process knowledge obtained during product development, and the "design space" is the area in which a product can be manufactured within acceptable limits. To create the spaces, artificial neural networks (ANNs) can be used to emphasize the multidimensional interactions of input variables and to closely bind these variables to a design space. This helps guide the experimental design process to include interactions among the input variables, along with modeling and optimization of pharmaceutical formulations. The objective of this study was to develop an integrated multivariate approach to obtain a quality product based on an understanding of the cause-effect relationships between formulation ingredients and product properties with ANNs and genetic programming on the ramipril tablets prepared by the direct compression method. In this study, the data are generated through the systematic application of the design of experiments (DoE) principles and optimization studies using artificial neural networks and neurofuzzy logic programs.

The robust design for improving crude palm oil quality in Indonesian Mill

NASA Astrophysics Data System (ADS)

Maretia Benu, Siti; Sinulingga, Sukaria; Matondang, Nazaruddin; Budiman, Irwan

2018-04-01

This research was conducted in palm oil mill in Sumatra Utara Province, Indonesia. Currently, the main product of this mill is Crude Palm Oil (CPO) and hasn’t met the expected standard quality. CPO is the raw material for many fat derivative products. The generally stipulated quality criteria are dirt count, free fatty acid, and moisture of CPO. The aim of this study is to obtain the optimal setting for factor’s affect the quality of CPO. The optimal setting will result in an improvement of product’s quality. In this research, Experimental Design with Taguchi Method is used. Steps of this method are identified influence factors, select the orthogonal array, processed data using ANOVA test and signal to noise ratio, and confirmed the research using Quality Loss Function. The result of this study using Taguchi Method is to suggest to set fruit maturity at 75.4-86.9%, digester temperature at 95°C and press at 21 Ampere to reduce quality deviation until 42.42%.

The German Quality Network Sepsis: study protocol for the evaluation of a quality collaborative on decreasing sepsis-related mortality in a quasi-experimental difference-in-differences design.

PubMed

Schwarzkopf, Daniel; Rüddel, Hendrik; Gründling, Matthias; Putensen, Christian; Reinhart, Konrad

2018-01-18

While sepsis-related mortality decreased substantially in other developed countries, mortality of severe sepsis remained as high as 44% in Germany. A recent German cluster randomized trial was not able to improve guideline adherence and decrease sepsis-related mortality within the participating hospitals, partly based on lacking support by hospital management and lacking resources for documentation of prospective data. Thus, more pragmatic approaches are needed to improve quality of sepsis care in Germany. The primary objective of the study is to decrease sepsis-related hospital mortality within a quality collaborative relying on claims data. The German Quality Network Sepsis (GQNS) is a quality collaborative involving 75 hospitals. This study protocol describes the conduction and evaluation of the start-up period of the GQNS running from March 2016 to August 2018. Democratic structures assure participatory action, a study coordination bureau provides central support and resources, and local interdisciplinary quality improvement teams implement changes within the participating hospitals. Quarterly quality reports focusing on risk-adjusted hospital mortality in cases with sepsis based on claims data are provided. Hospitals committed to publish their individual risk-adjusted mortality compared to the German average. A complex risk-model is used to control for differences in patient-related risk factors. Hospitals are encouraged to implement a bundle of interventions, e.g., interdisciplinary case analyses, external peer-reviews, hospital-wide staff education, and implementation of rapid response teams. The effectiveness of the GQNS is evaluated in a quasi-experimental difference-in-differences design by comparing the change of hospital mortality of cases with sepsis with organ dysfunction from a retrospective baseline period (January 2014 to December 2015) and the intervention period (April 2016 to March 2018) between the participating hospitals and all other German

Water quality and habitat conditions in upper Midwest streams relative to riparian vegetation and soil characteristics, August 1997 : study design, methods, and data

USGS Publications Warehouse

Sorenson, S.K.; Porter, S.D.; Akers, K.B.; Harris, M.A.; Kalkhoff, S.J.; Lee, K.E.; Roberts, L.; Terrio, P.J.

1999-01-01

Water-chemistry, biological, and habitat data were collected from 70 sites on Midwestern streams during August 1997 as part of an integrated, regional water-quality assessment by the U.S. Geological Survey National Water-Quality Assessment (NAWQA) Program. The study area includes the Corn Belt region of southern Minnesota, eastern Iowa, and west-central Illinois, one of the most intensive and productive agricultural regions of the world. The focus of the study was to evaluate the condition of woodedriparian zones and the influence of basin soildrainage characteristics on water quality and biological-community responses. This report includes a description of the study design and site-characterization process, sample-collection and processing methods, laboratory methods, quality-assurance procedures, and summaries of data on nutrients, herbicides and metabolites, stream productivity and respiration, biological communities, habitat conditions, and agriculturalchemical and land-use information.

Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process.

PubMed

Hubert, C; Lebrun, P; Houari, S; Ziemons, E; Rozet, E; Hubert, Ph

2014-01-01

The understanding of the method is a major concern when developing a stability-indicating method and even more so when dealing with impurity assays from complex matrices. In the presented case study, a Quality-by-Design approach was applied in order to optimize a routinely used method. An analytical issue occurring at the last stage of a long-term stability study involving unexpected impurities perturbing the monitoring of characterized impurities needed to be resolved. A compliant Quality-by-Design (QbD) methodology based on a Design of Experiments (DoE) approach was evaluated within the framework of a Liquid Chromatography (LC) method. This approach allows the investigation of Critical Process Parameters (CPPs), which have an impact on Critical Quality Attributes (CQAs) and, consequently, on LC selectivity. Using polynomial regression response modeling as well as Monte Carlo simulations for error propagation, Design Space (DS) was computed in order to determine robust working conditions for the developed stability-indicating method. This QbD compliant development was conducted in two phases allowing the use of the Design Space knowledge acquired during the first phase to define the experimental domain of the second phase, which constitutes a learning process. The selected working condition was then fully validated using accuracy profiles based on statistical tolerance intervals in order to evaluate the reliability of the results generated by this LC/ESI-MS stability-indicating method. A comparison was made between the traditional Quality-by-Testing (QbT) approach and the QbD strategy, highlighting the benefit of this QbD strategy in the case of an unexpected impurities issue. On this basis, the advantages of a systematic use of the QbD methodology were discussed. Copyright © 2013 Elsevier B.V. All rights reserved.

Implementing Quality Criteria in Designing and Conducting a Sequential Quan [right arrow] Qual Mixed Methods Study of Student Engagement with Learning Applied Research Methods Online

ERIC Educational Resources Information Center

Ivankova, Nataliya V.

2014-01-01

In spite of recent methodological developments related to quality assurance in mixed methods research, practical examples of how to implement quality criteria in designing and conducting sequential QUAN [right arrow] QUAL mixed methods studies to ensure the process is systematic and rigorous remain scarce. This article discusses a three-step…

Methodological quality of behavioural weight loss studies: a systematic review

PubMed Central

Lemon, S. C.; Wang, M. L.; Haughton, C. F.; Estabrook, D. P.; Frisard, C. F.; Pagoto, S. L.

2018-01-01

Summary This systematic review assessed the methodological quality of behavioural weight loss intervention studies conducted among adults and associations between quality and statistically significant weight loss outcome, strength of intervention effectiveness and sample size. Searches for trials published between January, 2009 and December, 2014 were conducted using PUBMED, MEDLINE and PSYCINFO and identified ninety studies. Methodological quality indicators included study design, anthropometric measurement approach, sample size calculations, intent-to-treat (ITT) analysis, loss to follow-up rate, missing data strategy, sampling strategy, report of treatment receipt and report of intervention fidelity (mean = 6.3). Indicators most commonly utilized included randomized design (100%), objectively measured anthropometrics (96.7%), ITT analysis (86.7%) and reporting treatment adherence (76.7%). Most studies (62.2%) had a follow-up rate >75% and reported a loss to follow-up analytic strategy or minimal missing data (69.9%). Describing intervention fidelity (34.4%) and sampling from a known population (41.1%) were least common. Methodological quality was not associated with reporting a statistically significant result, effect size or sample size. This review found the published literature of behavioural weight loss trials to be of high quality for specific indicators, including study design and measurement. Identified for improvement include utilization of more rigorous statistical approaches to loss to follow up and better fidelity reporting. PMID:27071775

Flying qualities - A costly lapse in flight-control design

NASA Technical Reports Server (NTRS)

Berry, D. T.

1982-01-01

Generic problems in advanced aircraft with advanced control systems which suffer from control sensitivity, sluggish response, and pilot-induced oscillation tendencies are examined, with a view to improving techniques for eliminating the problems in the design phase. Results of two NASA and NASA/AIAA workshops reached a consensus that flying qualities criteria do not match control system development, control system designers are not relying on past experience in their field, ground-based simulation is relied on too heavily, and communications between flying qualities and control systems engineers need improvement. A summation is offered in that hardware and software have outstripped the pilot's capacity to use the capabilities which new aircraft offer. The flying qualities data base is stressed to be dynamic, and continually redefining the man/machine relationships.

Academic Success Through Quality-Managed Course Design.

ERIC Educational Resources Information Center

Reese, Andy C.; Mobley, Mary F.

1996-01-01

Principles of quality management, focusing on defect prevention rather than correction, were applied to the design of a graduate biomedicine course in immunology. The principles require clearly stated course mission and objectives, numerous intermediate steps to achieving objectives, immediate feedback on student performance, and immediate…

Building quality into medical product software design.

PubMed

Mallory, S R

1993-01-01

The software engineering and quality assurance disciplines are a requisite to the design of safe and effective software-based medical devices. It is in the areas of software methodology and process that the most beneficial application of these disciplines to software development can be made. Software is a product of complex operations and methodologies and is not amenable to the traditional electromechanical quality assurance processes. Software quality must be built in by the developers, with the software verification and validation engineers acting as the independent instruments for ensuring compliance with performance objectives and with development and maintenance standards. The implementation of a software quality assurance program is a complex process involving management support, organizational changes, and new skill sets, but the benefits are profound. Its rewards provide safe, reliable, cost-effective, maintainable, and manageable software, which may significantly speed the regulatory review process and therefore potentially shorten the overall time to market. The use of a trial project can greatly facilitate the learning process associated with the first-time application of a software quality assurance program.

A quality by design approach to investigate the effect of mannitol and dicalcium phosphate qualities on roll compaction.

PubMed

Souihi, Nabil; Dumarey, Melanie; Wikström, Håkan; Tajarobi, Pirjo; Fransson, Magnus; Svensson, Olof; Josefson, Mats; Trygg, Johan

2013-04-15

Roll compaction is a continuous process for solid dosage form manufacturing increasingly popular within pharmaceutical industry. Although roll compaction has become an established technique for dry granulation, the influence of material properties is still not fully understood. In this study, a quality by design (QbD) approach was utilized, not only to understand the influence of different qualities of mannitol and dicalcium phosphate (DCP), but also to predict critical quality attributes of the drug product based solely on the material properties of that filler. By describing each filler quality in terms of several representative physical properties, orthogonal projections to latent structures (OPLS) was used to understand and predict how those properties affected drug product intermediates as well as critical quality attributes of the final drug product. These models were then validated by predicting product attributes for filler qualities not used in the model construction. The results of this study confirmed that the tensile strength reduction, known to affect plastic materials when roll compacted, is not prominent when using brittle materials. Some qualities of these fillers actually demonstrated improved compactability following roll compaction. While direct compression qualities are frequently used for roll compacted drug products because of their excellent flowability and good compaction properties, this study revealed that granules from these qualities were more poor flowing than the corresponding powder blends, which was not seen for granules from traditional qualities. The QbD approach used in this study could be extended beyond fillers. Thus any new compound/ingredient would first be characterized and then suitable formulation characteristics could be determined in silico, without running any additional experiments. Copyright © 2013 Elsevier B.V. All rights reserved.

Three-dimensional desirability spaces for quality-by-design-based HPLC development.

PubMed

Mokhtar, Hatem I; Abdel-Salam, Randa A; Hadad, Ghada M

2015-04-01

In this study, three-dimensional desirability spaces were introduced as a graphical representation method of design space. This was illustrated in the context of application of quality-by-design concepts on development of a stability indicating gradient reversed-phase high-performance liquid chromatography method for the determination of vinpocetine and α-tocopheryl acetate in a capsule dosage form. A mechanistic retention model to optimize gradient time, initial organic solvent concentration and ternary solvent ratio was constructed for each compound from six experimental runs. Then, desirability function of each optimized criterion and subsequently the global desirability function were calculated throughout the knowledge space. The three-dimensional desirability spaces were plotted as zones exceeding a threshold value of desirability index in space defined by the three optimized method parameters. Probabilistic mapping of desirability index aided selection of design space within the potential desirability subspaces. Three-dimensional desirability spaces offered better visualization and potential design spaces for the method as a function of three method parameters with ability to assign priorities to this critical quality as compared with the corresponding resolution spaces. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Effect of Additives on Green Sand Molding Properties using Design of Experiments and Taguchi's Quality Loss Function - An Experimental Study

NASA Astrophysics Data System (ADS)

Desai, Bhagyashree; Mokashi, Pavani; Anand, R. L.; Burli, S. B.; Khandal, S. V.

2016-09-01

The experimental study aims to underseek the effect of various additives on the green sand molding properties as a particular combination of additives could yield desired sand properties. The input parameters (factors) selected were water and powder (Fly ash, Coconut shell and Tamarind) in three levels. Experiments were planned using design of experiments (DOE). On the basis of plans, experiments were conducted to understand the behavior of sand mould properties such as compression strength, shear strength, permeability number with various additives. From the experimental results it could be concluded that the factors have significant effect on the sand properties as P-value found to be less than 0.05 for all the cases studied. The optimization based on quality loss function was also performed. The study revealed that the quality loss associated with the tamarind powder was lesser compared to other additives selected for the study. The optimization based on quality loss function and the parametric analysis using ANOVA suggested that the tamarind powder of 8 gm per Kg of molding sand and moisture content of 7% yield better properties to obtain sound castings.

Application of quality by design (QbD) to formulation and processing of naproxen pellets by extrusion-spheronization.

PubMed

Wang, Junlin; Kan, Shuling; Chen, Tong; Liu, Jianping

2015-03-01

The aim of this research was to apply quality by design (QbD) to the development of naproxen loaded core pellets which can be used as the potential core for colon-specific pellets. In the early stages of this study, prior knowledge and preliminary studies were systematically incorporated into the risk assessment using failure mode and effect analysis (FMEA) and fishbone diagram. Then Plackett-Burman design was used to screen eight potential high risk factors (spheronization speed, spheronization time, extrusion speed, drying method, CCMC-Na concentration, lactose concentration, water concentration and Tween 80 concentration) obtained from the above risk assessment. It was discovered that out of the eight potential high risk factors only three factors (spheronization speed, extrusion speed and CCMC-Na concentration) had significant effects on the quality of the pellets. This allowed the use of Box-Behnken design (BBD) to fully elucidate the relationship between the variables and critical quality attribute (CQA). Finally, the final control space was established within which the quality of the pellets can meet the requirement of colon-specific drug delivery system. This study demonstrated that naproxen loaded core pellets were successfully designed using QbD principle.

75 FR 71033 - Air Quality Designations for the 2008 Lead (Pb) National Ambient Air Quality Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-22

.... These include damage to the central nervous system, cardiovascular function, kidneys, immune system, and... growth); (5) Meteorology (weather/transport patterns); (6) Geography/topography (mountain ranges or other... Air Quality Designations for the 2008 Lead (Pb) National Ambient Air Quality Standards AGENCY...

Integrating Kano’s Model into Quality Function Deployment for Product Design: A Comprehensive Review

NASA Astrophysics Data System (ADS)

Ginting, Rosnani; Hidayati, Juliza; Siregar, Ikhsan

2018-03-01

Many methods and techniques are adopted by some companies to improve the competitiveness through the fulfillment of customer satisfaction by enhancement and improvement the product design quality. Over the past few years, several researcher have studied extensively combining Quality Function Deployment and Kano’s model as design techniques by focusing on translating consumer desires into a product design. This paper presents a review and analysis of several literatures that associated to the integration methodology of Kano into the QFD process. Various of international journal articles were selected, collected and analyzed through a number of relevant scientific publications. In-depth analysis was performed, and focused in this paper on the results, advantages and drawbacks of its methodology. In addition, this paper also provides the analysis that acquired in this study related to the development of the methodology. It is hopedd this paper can be a reference for other researchers and manufacturing companies to implement the integration method of QFD- Kano for product design.

Impact of National Ambient Air Quality Standards Nonattainment Designations on Particulate Pollution and Health.

PubMed

Zigler, Corwin M; Choirat, Christine; Dominici, Francesca

2018-03-01

Despite dramatic air quality improvement in the United States over the past decades, recent years have brought renewed scrutiny and uncertainty surrounding the effectiveness of specific regulatory programs for continuing to improve air quality and public health outcomes. We employ causal inference methods and a spatial hierarchical regression model to characterize the extent to which a designation of "nonattainment" with the 1997 National Ambient Air Quality Standard for ambient fine particulate matter (PM2.5) in 2005 causally affected ambient PM2.5 and health outcomes among over 10 million Medicare beneficiaries in the Eastern United States in 2009-2012. We found that, on average across all retained study locations, reductions in ambient PM2.5 and Medicare health outcomes could not be conclusively attributed to the nonattainment designations against the backdrop of other regional strategies that impacted the entire Eastern United States. A more targeted principal stratification analysis indicates substantial health impacts of the nonattainment designations among the subset of areas where the designations are estimated to have actually reduced ambient PM2.5 beyond levels achieved by regional measures, with noteworthy reductions in all-cause mortality, chronic obstructive pulmonary disorder, heart failure, ischemic heart disease, and respiratory tract infections. These findings provide targeted evidence of the effectiveness of local control measures after nonattainment designations for the 1997 PM2.5 air quality standard.

A slow fashion design model for bluejeans using house of quality approach

NASA Astrophysics Data System (ADS)

Nergis, B.; Candan, C.; Sarısaltık, S.; Seneloglu, N.; Bozuk, R.; Amzayev, K.

2017-10-01

The purpose of this study was to develop a slow fashion design model using the house of quality model (HOQ) to provide fashion designers a tool to improve the overall sustainability of denim jeans for Y generation consumers in Turkish market. In doing so, a survey was conducted to collect data on the design & performance expectations as well as the perception of slow fashion in design process of denim jeans of the targeted consumer group. The results showed that Y generation in the market gave the most importance to the sustainable production techniques when identifying slow fashion.

How does the environment impact on the quality of life of advanced cancer patients? A qualitative study with implications for ward design.

PubMed

Rowlands, J; Noble, S

2008-09-01

It is well recognized that the ward environment has an effect on patients' quality of life and may, therefore, impact on the quality of end of life care. The body of evidence that informs ward design policy recommends single-bedded rooms on grounds of reduced infection risk, noise and versatility. Considering the majority of anticipated patient deaths occurring in hospitals, the quality of life aspects of ward design should also be considered. The aim of this study is to explore the views of patients with advanced cancer on the effect the ward environment has on their overall well-being. Semi-structured interviews exploring the experiences of 12 inpatients at a regional cancer centre were recorded and transcribed verbatim. Transcripts were analysed for emerging themes until theoretical saturation. Four major themes emerged: staff behaviours, the immediate environment, single vs. multi-bedded rooms and contact with the outside environment. The attitude, competence and helpfulness of the staff creates the atmosphere of the ward regardless of layout, furnishings, equipment and décor. The majority of the patients in this study expressed a strong preference for a multi-bedded room when they were well enough to interact and a single cubicle when they were very ill or dying, which opposes the current advice for building new hospitals with all single rooms. Although the current policy recommends the use of single-bedded rooms, this study suggests the need for a mix of multi-bedded wards and single rooms with respect to the impact of the environment on patient quality of life.

Evaluating an integrated approach to clinical quality improvement: clinical guidelines, quality measurement, and supportive system design.

PubMed

Cretin, S; Farley, D O; Dolter, K J; Nicholas, W

2001-08-01

Implementing clinical practice guidelines to change patient outcomes presents a challenge. Studies of single interventions focused on changing provider behavior demonstrate modest effects, suggesting that effective guideline implementation requires a multifaceted approach. Traditional biomedical research designs are not well suited to evaluating systems interventions. RAND and the Army Medical Department collaborated to develop and evaluate a system for implementing guidelines and documenting their effects on patient care. The evaluation design blended quality improvement, case study, and epidemiologic methods. A formative evaluation of implementation process and an outcome evaluation of patient impact were combined. Guidelines were implemented in 3 successive demonstrations targeting low back pain, asthma, and diabetes. This paper reports on the first wave of 4 facilities implementing a low back pain guideline. Organizational climate and culture, motivation, leadership commitment, and resources were assessed. Selected indicators of processes and outcomes of care were compared before, during, and after guideline implementation at the demonstration facilities and at comparison facilities. Logistic regression analysis was used to test for guideline effects on patient care. Process evaluation documented varied approaches to quality improvement across sites. Outcome evaluation revealed a significant downward trend in the percentage of acute low back pain patients referred to physical therapy or chiropractic care (10.7% to 7.2%) at demonstration sites and no such trend at control sites. Preliminary results suggest the power of this design to stimulate improvements in guideline implementation while retaining the power to evaluate rigorously effects on patient care.

Ethical challenges in designing and conducting medicine quality surveys.

PubMed

Tabernero, Patricia; Parker, Michael; Ravinetto, Raffaella; Phanouvong, Souly; Yeung, Shunmay; Kitutu, Freddy E; Cheah, Phaik Yeong; Mayxay, Mayfong; Guerin, Philippe J; Newton, Paul N

2016-06-01

In this paper we discuss the main ethical challenges related to the conduct of medicine quality surveys and make suggestions on how to address them. Most evidence-based information regarding medicine quality derives from surveys. However, existing research ethical guidelines do not provide specific guidance for medicine quality surveys. Hence, those conducting surveys are often left wondering how to judge what counts as best practice. A list of the main ethical challenges in the design and conduct of surveys is presented. It is vital that the design and conduct of medicine quality surveys uphold moral and ethical obligations and analyse the ethical implications and consequences of such work. These aspects include the impact on the local availability of and access to medicines; the confidentiality and privacy of the surveyors and the surveyed; questions as to whether outlet staff personnel should be told they are part of a survey; the need of ethical and regulatory approvals; and how the findings should be disseminated. Medicine quality surveys should ideally be conducted in partnership with the relevant national Medicine Regulatory Authorities. An international, but contextually sensitive, model of good ethical practice for such surveys is needed. © 2016 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

Small cause - big effect: improvement in interface design results in improved data quality - a multicenter crossover study.

PubMed

Ahlbrandt, Janko; Henrich, Michael; Hartmann, Bernd A; Bundschuh, Bettina B; Schwarz, Julia; Klasen, Joachim; Röhrig, Rainer

2012-01-01

In Germany the core data set for anesthesia version 3.0 was recently introduced for external quality assurance, which includes five surgical tracer procedures. We found a low rate of correctly documented tracers when compared to procedure data (OPS-Codes) documented separately. Examination revealed that the graphical user interface (GUI) contravened the dialogue principles as defined in EN ISO 9241-110. We worked with the manufacturer to implement small improvements and roll out the software. A crossover study was conducted at a university hospital and a municipal hospital chain with five hospitals. All study sites and surgical tracer procedures combined, we found an improvement from 42% to 65% (p<0.001; N=34,610) correctly documented anesthesias. We also saw improvements for most of the observed surgical tracer procedures at all hospitals. Our results show the big effect small changes to the GUI can have on data quality. They also raise the question, if highly flexible and parameterized clinical documentation systems are suited to achieve high usability. Finding the right balance between GUIs designed by usability experts and the flexibility of parameterization by administrators will be a difficult task for the future and subject to further research.

Enhancing the quality of case studies in health services research.

PubMed Central

Yin, R K

1999-01-01

OBJECTIVE: To provide guidance on improving the quality of case studies in health services research. DATA SOURCES: Secondary data, drawing from previous case study research. RESEARCH DESIGN: Guidance is provided to two audiences: potential case study investigators (eight items) and reviewers of case study proposals (four additional items). PRINCIPAL FINDINGS: The guidance demonstrates that many operational steps can be undertaken to improve the quality of case studies. These steps have been a hallmark of high-quality case studies in related fields but have not necessarily been practiced in health services research. CONCLUSIONS: Given higher-quality case studies, the case study method can become a valuable tool for health services research. Images Figure 3 PMID:10591280

Design and simulation study of the immunization Data Quality Audit (DQA).

PubMed

Woodard, Stacy; Archer, Linda; Zell, Elizabeth; Ronveaux, Olivier; Birmingham, Maureen

2007-08-01

The goal of the Data Quality Audit (DQA) is to assess whether the Global Alliance for Vaccines and Immunization-funded countries are adequately reporting the number of diphtheria-tetanus-pertussis immunizations given, on which the "shares" are awarded. Given that this sampling design is a modified two-stage cluster sample (modified because a stratified, rather than a simple, random sample of health facilities is obtained from the selected clusters); the formula for the calculation of the standard error for the estimate is unknown. An approximated standard error has been proposed, and the first goal of this simulation is to assess the accuracy of the standard error. Results from the simulations based on hypothetical populations were found not to be representative of the actual DQAs that were conducted. Additional simulations were then conducted on the actual DQA data to better access the precision of the DQ with both the original and the increased sample sizes.

Controlling Pollutants and Sources: Indoor Air Quality Design Tools for Schools

EPA Pesticide Factsheets

To protect indoor environmental quality the designer should understand indoor air quality problems and seek to eliminate potential sources of contamination that originate from outdoors as well as indoors.

Evaluating a community-based program to improve healthcare quality: research design for the Aligning Forces for Quality initiative.

PubMed

Scanlon, Dennis P; Alexander, Jeffrey A; Beich, Jeff; Christianson, Jon B; Hasnain-Wynia, Romana; McHugh, Megan C; Mittler, Jessica N; Shi, Yunfeng; Bodenschatz, Laura J

2012-09-01

The Aligning Forces for Quality (AF4Q) initiative is the Robert Wood Johnson Foundation's (RWJF's) signature effort to increase the overall quality of healthcare in targeted communities throughout the country. In addition to sponsoring this 16-site, complex program, the RWJF funds an independent scientific evaluation to support objective research on the initiative's effectiveness and contributions to basic knowledge in 5 core programmatic areas. The research design, data, and challenges faced in the evaluation of this 10-year initiative are discussed. A descriptive overview of the evaluation research design for a multi-site, community based, healthcare quality improvement initiative is provided. The multiphase research design employed by the evaluation team is discussed. Evaluation provides formative feedback to the RWJF, participants, and other interested audiences in real time; develops approaches to assess innovative and under-studied interventions; furthers the analysis and understanding of effective community-based collaborative work in healthcare; and helps to differentiate the various facilitators, barriers, and contextual dimensions that affect the implementation and outcomes of community-based health interventions. The AF4Q initiative is arguably the largest community-level healthcare improvement demonstration in the United States to date; it is being implemented at a time of rapid change in national healthcare policy. The implementation of large-scale, multi-site initiatives is becoming an increasingly common approach for addressing problems in healthcare. The evaluation research design for the AF4Q initiative, and the lessons learned from its approach, may be valuable to others tasked with evaluating similar community-based initiatives.

Off-Line Quality Control In Integrated Circuit Fabrication Using Experimental Design

NASA Astrophysics Data System (ADS)

Phadke, M. S.; Kackar, R. N.; Speeney, D. V.; Grieco, M. J.

1987-04-01

Off-line quality control is a systematic method of optimizing production processes and product designs. It is widely used in Japan to produce high quality products at low cost. The method was introduced to us by Professor Genichi Taguchi who is a Deming-award winner and a former Director of the Japanese Academy of Quality. In this paper we will i) describe the off-line quality control method, and ii) document our efforts to optimize the process for forming contact windows in 3.5 Aim CMOS circuits fabricated in the Murray Hill Integrated Circuit Design Capability Laboratory. In the fabrication of integrated circuits it is critically important to produce contact windows of size very near the target dimension. Windows which are too small or too large lead to loss of yield. The off-line quality control method has improved both the process quality and productivity. The variance of the window size has been reduced by a factor of four. Also, processing time for window photolithography has been substantially reduced. The key steps of off-line quality control are: i) Identify important manipulatable process factors and their potential working levels. ii) Perform fractional factorial experiments on the process using orthogonal array designs. iii) Analyze the resulting data to determine the optimum operating levels of the factors. Both the process mean and the process variance are considered in this analysis. iv) Conduct an additional experiment to verify that the new factor levels indeed give an improvement.

Translational Research in South Africa: Evaluating Implementation Quality Using a Factorial Design

PubMed Central

Smith, Edward A.; Collins, Linda M.; Graham, John W.; Lai, Mary; Wegner, Lisa; Vergnani, Tania; Matthews, Catherine; Jacobs, Joachim

2012-01-01

Background HealthWise South Africa: Life Skills for Adolescents (HW) is an evidence-based substance use and sexual risk prevention program that emphasizes the positive use of leisure time. Since 2000, this program has evolved from pilot testing through an efficacy trial involving over 7,000 youth in the Cape Town area. Beginning in 2011, through 2015, we are undertaking a new study that expands HW to all schools in the Metro South Education District. Objective This paper describes a research study designed in partnership with our South African collaborators that examines three factors hypothesized to affect the quality and fidelity of HW implementation: enhanced teacher training; teacher support, structure and supervision; and enhanced school environment. Methods Teachers and students from 56 schools in the Cape Town area will participate in this study. Teacher observations are the primary means of collecting data on factors affecting implementation quality. These factors address the practical concerns of teachers and schools related to likelihood of use and cost-effectiveness, and are hypothesized to be “active ingredients” related to high-quality program implementation in real-world settings. An innovative factorial experimental design was chosen to enable estimation of the individual effect of each of the three factors. Results Because this paper describes the conceptualization of our study, results are not yet available. Conclusions The results of this study may have both substantive and methodological implications for advancing Type 2 translational research. PMID:22707870

Lithography-induced limits to scaling of design quality

NASA Astrophysics Data System (ADS)

Kahng, Andrew B.

2014-03-01

Quality and value of an IC product are functions of power, performance, area, cost and reliability. The forthcoming 2013 ITRS roadmap observes that while manufacturers continue to enable potential Moore's Law scaling of layout densities, the "realizable" scaling in competitive products has for some years been significantly less. In this paper, we consider aspects of the question, "To what extent should this scaling gap be blamed on lithography?" Non-ideal scaling of layout densities has been attributed to (i) layout restrictions associated with multi-patterning technologies (SADP, LELE, LELELE), as well as (ii) various ground rule and layout style choices that stem from misalignment, reliability, variability, device architecture, and electrical performance vs. power constraints. Certain impacts seem obvious, e.g., loss of 2D flexibility and new line-end placement constraints with SADP, or algorithmically intractable layout stitching and mask coloring formulations with LELELE. However, these impacts may well be outweighed by weaknesses in design methodology and tooling. Arguably, the industry has entered a new era in which many new factors - (i) standard-cell library architecture, and layout guardbanding for automated place-and-route: (ii) performance model guardbanding and signoff analyses: (iii) physical design and manufacturing handoff algorithms spanning detailed placement and routing, stitching and RET; and (iv) reliability guardbanding - all contribute, hand in hand with lithography, to a newly-identified "design capability gap". How specific aspects of process and design enablements limit the scaling of design quality is a fundamental question whose answer must guide future RandD investment at the design-manufacturing interface. terface.

77 FR 9532 - Air Quality Designations for the 2010 Primary Nitrogen Dioxide (NO2

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-17

...This rule establishes air quality designations for all areas in the United States for the 2010 Primary Nitrogen Dioxide (NO2) National Ambient Air Quality Standards (NAAQS). Based on air quality monitoring data, the EPA is issuing this rule to designate all areas of the country as ``unclassifiable/attainment'' for the 2010 NO2 NAAQS. The EPA is designating areas as ``unclassifiable/attainment'' to mean that available information does not indicate that the air quality in these areas exceeds the 2010 NO2 NAAQS.

[Strengthening the methodology of study designs in scientific researches].

PubMed

Ren, Ze-qin

2010-06-01

Many problems in study designs have affected the validity of scientific researches seriously. We must understand the methodology of research, especially clinical epidemiology and biostatistics, and recognize the urgency in selection and implement of right study design. Thereafter we can promote the research capability and improve the overall quality of scientific researches.

Community Building, Emergent Design and Expecting the Unexpected: Creating a Quality eLearning Experience

ERIC Educational Resources Information Center

Thompson, Terrie Lynn; MacDonald, Colla J.

2005-01-01

Given the extraordinary interest and growth in eLearning as a learning tool and as an industry, it is not surprising there is lively debate on quality. A research-based and tested eLearning model was used to design and evaluate an online M.Ed. course in order to study factors that influence the quality of an eLearning event. Several data…

Applying Quality Indicators to Single-Case Research Designs Used in Special Education: A Systematic Review

ERIC Educational Resources Information Center

Moeller, Jeremy D.; Dattilo, John; Rusch, Frank

2015-01-01

This study examined how specific guidelines and heuristics have been used to identify methodological rigor associated with single-case research designs based on quality indicators developed by Horner et al. Specifically, this article describes how literature reviews have applied Horner et al.'s quality indicators and evidence-based criteria.…

The use of the general image quality equation in the design and evaluation of imaging systems

NASA Astrophysics Data System (ADS)

Cota, Steve A.; Florio, Christopher J.; Duvall, David J.; Leon, Michael A.

2009-08-01

The design of any modern imaging system is the end result of many trade studies, each seeking to optimize image quality within real world constraints such as cost, schedule and overall risk. The National Imagery Interpretability Rating Scale (NIIRS) is a useful measure of image quality, because, by characterizing the overall interpretability of an image, it combines into one metric those contributors to image quality to which a human interpreter is most sensitive. The main drawback to using a NIIRS rating as a measure of image quality in engineering trade studies is the fact that it is tied to the human observer and cannot be predicted from physical principles and engineering parameters alone. The General Image Quality Equation (GIQE) of Leachtenauer et al. 1997 [Appl. Opt. 36, 8322-8328 (1997)] is a regression of actual image analyst NIIRS ratings vs. readily calculable engineering metrics, and provides a mechanism for using the expected NIIRS rating of an imaging system in the design and evaluation process. In this paper, we will discuss how we use the GIQE in conjunction with The Aerospace Corporation's Parameterized Image Chain Analysis & Simulation SOftware (PICASSO) to evaluate imager designs, taking a hypothetical high resolution commercial imaging system as an example.

76 FR 76048 - Air Quality Designations for the 2008 Lead (Pb) National Ambient Air Quality Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-HQ-OAR-2009-0443; FRL-9492-3] RIN 2060-AR17 Air Quality Designations for the 2008 Lead (Pb) National Ambient Air Quality Standards Correction In rule document 2011-29460 appearing on pages 72097-72120 in the issues of Tuesday, November 22, 2011...

Design of a ground-water-quality monitoring network for the Salinas River basin, California

USGS Publications Warehouse

Showalter, P.K.; Akers, J.P.; Swain, L.A.

1984-01-01

A regional ground-water quality monitoring network for the entire Salinas River drainage basin was designed to meet the needs of the California State Water Resources Control Board. The project included phase 1--identifying monitoring networks that exist in the region; phase 2--collecting information about the wells in each network; and phase 3--studying the factors--such as geology, land use, hydrology, and geohydrology--that influence the ground-water quality, and designing a regional network. This report is the major product of phase 3. Based on the authors ' understanding of the ground-water-quality monitoring system and input from local offices, an ideal network was designed. The proposed network includes 317 wells and 8 stream-gaging stations. Because limited funds are available to implement the monitoring network, the proposed network is designed to correspond to the ideal network insofar as practicable, and is composed mainly of 214 wells that are already being monitored by a local agency. In areas where network wells are not available, arrangements will be made to add wells to local networks. The data collected by this network will be used to assess the ground-water quality of the entire Salinas River drainage basin. After 2 years of data are collected, the network will be evaluated to test whether it is meeting the network objectives. Subsequent network evaluations will be done very 5 years. (USGS)

Near-Road Air Quality Monitoring: Factors Affecting Network Design and Interpretation of Data

EPA Science Inventory

The growing number of health studies identifying adverse health effects for populations spending significant amounts of time near large roadways has increased the interest in monitoring air quality in this microenvironment. Designing near-road air monitoring networks or interpret...

Application of Quality by Design to the characterization of the cell culture process of an Fc-Fusion protein.

PubMed

Rouiller, Yolande; Solacroup, Thomas; Deparis, Véronique; Barbafieri, Marco; Gleixner, Ralf; Broly, Hervé; Eon-Duval, Alex

2012-06-01

The production bioreactor step of an Fc-Fusion protein manufacturing cell culture process was characterized following Quality by Design principles. Using scientific knowledge derived from the literature and process knowledge gathered during development studies and manufacturing to support clinical trials, potential critical and key process parameters with a possible impact on product quality and process performance, respectively, were determined during a risk assessment exercise. The identified process parameters were evaluated using a design of experiment approach. The regression models generated from the data allowed characterizing the impact of the identified process parameters on quality attributes. The main parameters having an impact on product titer were pH and dissolved oxygen, while those having the highest impact on process- and product-related impurities and variants were pH and culture duration. The models derived from characterization studies were used to define the cell culture process design space. The design space limits were set in such a way as to ensure that the drug substance material would consistently have the desired quality. Copyright © 2012 Elsevier B.V. All rights reserved.

Effluent quality from 200 on-site sewage systems: design values for guidelines.

PubMed

Charles, K J; Ashbolt, N J; Roser, D J; McGuinness, R; Deere, D A

2005-01-01

The quality of effluent from an on-site sewage treatment system is a critical factor in designing the disposal area and, hence, ensuring the sustained performance of the system. Contaminant concentrations in effluent are typically specified in regulatory guidelines or standards; however, the accuracy of these guideline values are brought into question due to the poor performance of septic tanks and the high failure rates of disposal systems reported here and elsewhere. Results from studies of septic tank effluent quality indicated that the effluent is of poorer quality than currently suggested by guidelines. Aerated wastewater treatment systems were found to perform to accreditation guidelines; however, insufficient nutrient data is presently available to assess nutrient loads. It is proposed that the 80th percentile of system performance be adopted as the design value for sizing effluent disposal areas to minimise failure associated with overloading. For septic tanks this equates to 660 mg L(-1) SS, 330 mg L(-1) BOD, 250 mg L(-1) TN and 36 mg L(-1) TP.

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics.

PubMed

Colombo, Stefano; Beck-Broichsitter, Moritz; Bøtker, Johan Peter; Malmsten, Martin; Rantanen, Jukka; Bohr, Adam

2018-04-05

Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field. Copyright © 2018 Elsevier B.V. All rights reserved.

Quality by design: optimization of a liquid filled pH-responsive macroparticles using Draper-Lin composite design.

PubMed

Rafati, Hasan; Talebpour, Zahra; Adlnasab, Laleh; Ebrahimi, Samad Nejad

2009-07-01

In this study, pH responsive macroparticles incorporating peppermint oil (PO) were prepared using a simple emulsification/polymer precipitation technique. The formulations were examined for their properties and the desired quality was then achieved using a quality by design (QBD) approach. For this purpose, a Draper-Lin small composite design study was employed in order to investigate the effect of four independent variables, including the PO to water ratio, the concentration of pH sensitive polymer (hydroxypropyl methylcellulose phthalate), acid and plasticizer concentrations, on the encapsulation efficiency and PO loading. The analysis of variance showed that the polymer concentration was the most important variable on encapsulation efficiency (p < 0.05). The multiple regression analysis of the results led to equations that adequately described the influence of the independent variables on the selected responses. Furthermore, the desirability function was employed as an effective tool for transforming each response separately and encompassing all of these responses in an overall desirability function for global optimization of the encapsulation process. The optimized macroparticles were predicted to yield 93.4% encapsulation efficiency and 72.8% PO loading, which were remarkably close to the experimental values of 89.2% and 69.5%, consequently.

Quality improvement of melt extruded laminar systems using mixture design.

PubMed

Hasa, D; Perissutti, B; Campisi, B; Grassi, M; Grabnar, I; Golob, S; Mian, M; Voinovich, D

2015-07-30

This study investigates the application of melt extrusion for the development of an oral retard formulation with a precise drug release over time. Since adjusting the formulation appears to be of the utmost importance in achieving the desired drug release patterns, different formulations of laminar extrudates were prepared according to the principles of Experimental Design, using a design for mixtures to assess the influence of formulation composition on the in vitro drug release from the extrudates after 1h and after 8h. The effect of each component on the two response variables was also studied. Ternary mixtures of theophylline (model drug), monohydrate lactose and microcrystalline wax (as thermoplastic binder) were extruded in a lab scale vertical ram extruder in absence of solvents at a temperature below the melting point of the binder (so that the crystalline state of the drug could be maintained), through a rectangular die to obtain suitable laminar systems. Thanks to the desirability approach and a reliability study for ensuring the quality of the formulation, a very restricted optimal zone was defined within the experimental domain. Among the mixture components, the variation of microcrystalline wax content played the most significant role in overall influence on the in vitro drug release. The formulation theophylline:lactose:wax, 57:14:29 (by weight), selected based on the desirability zone, was subsequently used for in vivo studies. The plasma profile, obtained after oral administration of the laminar extruded system in hard gelatine capsules, revealed the typical trend of an oral retard formulation. The application of the mixture experimental design associated to a desirability function permitted to optimize the extruded system and to determine the composition space that ensures final product quality. Copyright © 2015 Elsevier B.V. All rights reserved.

30 CFR 27.20 - Quality of material, workmanship, and design.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality of material, workmanship, and design. 27.20 Section 27.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Construction and Design...

30 CFR 27.20 - Quality of material, workmanship, and design.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality of material, workmanship, and design. 27.20 Section 27.20 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Construction and Design...

Application of quality by design concepts in the development of fluidized bed granulation and tableting processes.

PubMed

Djuris, Jelena; Medarevic, Djordje; Krstic, Marko; Djuric, Zorica; Ibric, Svetlana

2013-06-01

This study illustrates the application of experimental design and multivariate data analysis in defining design space for granulation and tableting processes. According to the quality by design concepts, critical quality attributes (CQAs) of granules and tablets, as well as critical parameters of granulation and tableting processes, were identified and evaluated. Acetaminophen was used as the model drug, and one of the study aims was to investigate the possibility of the development of immediate- or extended-release acetaminophen tablets. Granulation experiments were performed in the fluid bed processor using polyethylene oxide polymer as a binder in the direct granulation method. Tablets were compressed in the laboratory excenter tablet press. The first set of experiments was organized according to Plackett-Burman design, followed by the full factorial experimental design. Principal component analysis and partial least squares regression were applied as the multivariate analysis techniques. By using these different methods, CQAs and process parameters were identified and quantified. Furthermore, an in-line method was developed to monitor the temperature during the fluidized bed granulation process, to foresee possible defects in granules CQAs. Various control strategies that are based on the process understanding and assure desired quality attributes of the product are proposed. Copyright © 2013 Wiley Periodicals, Inc.

Buffer strip design for protecting water quality and fish habitat

DOE Office of Scientific and Technical Information (OSTI.GOV)

Belt, G.H.; O'Laughlin, J.

1994-04-01

Buffer strips are protective areas adjacent to streams or lakes. Among other functions, they protect water quality and fish habitat. A typical buffer strip is found in western Oregon, where they are called Riparian Management Areas (RMAs). The authors use the term buffer strip to include functional descriptions such as filter, stabilization, or leave strips, and administrative designations such as Idaho's Stream Protection Zone (SPZ), Washington's Riparian Management Zone (RMZ), and the USDA Forest Service's Streamside Management Zone (SMZ). They address water quality and fishery protective functions of buffer strips on forestlands, pointing out improvements in buffer strip design possiblemore » through research or administrative changes. Buffer strip design requirements found in some western Forest Practices Act (FPA) regulations are also compared and related to findings in the scientific literature.« less

Extending cluster Lot Quality Assurance Sampling designs for surveillance programs

PubMed Central

Hund, Lauren; Pagano, Marcello

2014-01-01

Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance based on the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible non-parametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. PMID:24633656

Development and evaluation of paclitaxel nanoparticles using a quality-by-design approach.

PubMed

Yerlikaya, Firat; Ozgen, Aysegul; Vural, Imran; Guven, Olgun; Karaagaoglu, Ergun; Khan, Mansoor A; Capan, Yilmaz

2013-10-01

The aims of this study were to develop and characterize paclitaxel nanoparticles, to identify and control critical sources of variability in the process, and to understand the impact of formulation and process parameters on the critical quality attributes (CQAs) using a quality-by-design (QbD) approach. For this, a risk assessment study was performed with various formulation and process parameters to determine their impact on CQAs of nanoparticles, which were determined to be average particle size, zeta potential, and encapsulation efficiency. Potential risk factors were identified using an Ishikawa diagram and screened by Plackett-Burman design and finally nanoparticles were optimized using Box-Behnken design. The optimized formulation was further characterized by Fourier transform infrared spectroscopy, X-ray diffractometry, differential scanning calorimetry, scanning electron microscopy, atomic force microscopy, and gas chromatography. It was observed that paclitaxel transformed from crystalline state to amorphous state while totally encapsulating into the nanoparticles. The nanoparticles were spherical, smooth, and homogenous with no dichloromethane residue. In vitro cytotoxicity test showed that the developed nanoparticles are more efficient than free paclitaxel in terms of antitumor activity (more than 25%). In conclusion, this study demonstrated that understanding formulation and process parameters with the philosophy of QbD is useful for the optimization of complex drug delivery systems. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

Quality-by-design approach for the development of telmisartan potassium tablets.

PubMed

Oh, Ga-Hui; Park, Jin-Hyun; Shin, Hye-Won; Kim, Joo-Eun; Park, Young-Joon

2018-05-01

A quality-by-design approach was adopted to develop telmisartan potassium (TP) tablets, which were bioequivalent with the commercially available Micardis ® (telmisartan free base) tablets. The dissolution pattern and impurity profile of TP tablets differed from those of Micardis ® tablets because telmisartan free base is poorly soluble in water. After identifying the quality target product profile and critical quality attributes (CQAs), drug dissolution, and impurities were predicted to be risky CQAs. To determine the exact range and cause of risks, we used the risk assessment (RA) tools, preliminary hazard analysis and failure mode and effect analysis to determine the parameters affecting drug dissolution, impurities, and formulation. The range of the design space was optimized using the face-centered central composite design among the design of experiment (DOE) methods. The binder, disintegrant, and kneading time in the wet granulation were identified as X values affecting Y values (disintegration, hardness, friability, dissolution, and impurities). After determining the design space with the desired Y values, the TP tablets were formulated and their dissolution pattern was compared with that of the reference tablet. The selected TP tablet formulated using design space showed a similar dissolution to that of Micardis ® tablets at pH 7.5. The QbD approach TP tablet was bioequivalent to Micardis ® tablets in beagle dogs.

A Design Quality Learning Unit in Relational Data Modeling Based on Thriving Systems Properties

ERIC Educational Resources Information Center

Waguespack, Leslie J.

2013-01-01

This paper presents a learning unit that addresses quality design in relational data models. The focus on modeling allows the learning to span analysis, design, and implementation enriching pedagogy across the systems development life cycle. Thriving Systems Theory presents fifteen choice properties that convey design quality in models integrating…

Shift work and quality of sleep: effect of working in designed dynamic light.

PubMed

Jensen, Hanne Irene; Markvart, Jakob; Holst, René; Thomsen, Tina Damgaard; Larsen, Jette West; Eg, Dorthe Maria; Nielsen, Lisa Seest

2016-01-01

To examine the effect of designed dynamic light on staff's quality of sleep with regard to sleep efficiency, level of melatonin in saliva, and subjective perceptions of quality of sleep. An intervention group working in designed dynamic light was compared with a control group working in ordinary institutional light at two comparable intensive care units (ICUs). The study included examining (1) melatonin profiles obtained from saliva samples, (2) quality of sleep in terms of sleep efficiency, number of awakenings and subjective assessment of sleep through the use of sleep monitors and sleep diaries, and (3) subjective perceptions of well-being, health, and sleep quality using a questionnaire. Light conditions were measured at both locations. A total of 113 nurses (88 %) participated. There were no significant differences between the two groups regarding personal characteristics, and no significant differences in total sleep efficiency or melatonin level were found. The intervention group felt more rested (OR 2.03, p = 0.003) and assessed their condition on awakening as better than the control group (OR 2.35, p = 0.001). Intervention-ICU nurses received far more light both during day and evening shifts compared to the control-ICU. The study found no significant differences in monitored sleep efficiency and melatonin level. Nurses from the intervention-ICU subjectively assessed their sleep as more effective than participants from the control-ICU.

Applying Quality by Design Concepts to Pharmacy Compounding.

PubMed

Timko, Robert J

2015-01-01

Compounding of medications is an important part of the practice of the pharmacy profession. Because compounded medications do not have U.S. Food and Drug Administration approval, a pharmacist has the responsibility to ensure that compounded medications are of suitable quality, safety, and efficacy. The Federal Government and numerous states have updated their laws and regulations regarding pharmacy compounding as a result of recent quality issues. Compounding pharmacists are expected to follow good preparation prodecures in their compounding practices in much the same way pharmaceutical manufacturers are required to follow Current Good Manufacturing Procedures as detailed in the United States Code of Federal Regulations. Application of Quality by Design concepts to the preparation process for a compounded medication can help in understanding the potential pitfalls and the means to mitigate their impact. The goal is to build quality into the compounding process to ensure that the resultant compounded prescription meets the human or animal patients' requirements.

Water-quality parameters and benthic algal communities at selected streams in Minnesota, August 2000 - Study design, methods and data

USGS Publications Warehouse

Lee, K.E.

2002-01-01

This report describes the study design, sampling methods, and summarizes the physical, chemical, and benthic algal data for a component of the multiagency study that was designed to document diurnal water-quality measurements (specific conductance, pH, water temperature, and dissolved oxygen), benthic algal community composition and chlorophyll-a content, and primary productivity at 12 stream sites on 6 streams in Minnesota during August 2000. Specific conductance, pH, water temperature, dissolved oxygen concentrations and percent dissolved oxygen saturation measurements were made with submersible data recorders at 30 minute intervals for a period of 3-6 days during August 2000. Benthic algae collected from wood and rock substrate were identified and enumerated. Biovolume (volume of algal cells per unit area), density (number of cells per unit area), and chlorophyll-a content from benthic algae were determined. These data can be used as part of the multiagency study to develop an understanding of the relations among nutrient concentrations, algal abundance, algal community composition, and primary production and respiration processes in rivers of differing ecoregions in Minnesota.

Implementation of quality by design toward processing of food products.

PubMed

Rathore, Anurag S; Kapoor, Gautam

2017-05-28

Quality by design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control. It is an approach based on principles of sound science and quality risk management. As the food processing industry continues to embrace the idea of in-line, online, and/or at-line sensors and real-time characterization for process monitoring and control, the existing gaps with regard to our ability to monitor multiple parameters/variables associated with the manufacturing process will be alleviated over time. Investments made for development of tools and approaches that facilitate high-throughput analytical and process development, process analytical technology, design of experiments, risk analysis, knowledge management, and enhancement of process/product understanding would pave way for operational and economic benefits later in the commercialization process and across other product pipelines. This article aims to achieve two major objectives. First, to review the progress that has been made in the recent years on the topic of QbD implementation in processing of food products and second, present a case study that illustrates benefits of such QbD implementation.

Flying qualities design criteria applicable to supersonic cruise aircraft

NASA Technical Reports Server (NTRS)

Chalk, C. R.

1980-01-01

A comprehensive set of flying qualities design criteria was prepared for use in the supersonic cruise research program. The framework for stating the design criteria is established and design criteria are included which address specific failures, approach to dangerous flight conditions, flight at high angle of attack, longitudinal and lateral directional stability and control, the primary flight control system, and secondary flight controls. Examples are given of lateral directional design criteria limiting lateral accelerations at the cockpit, time to roll through 30 deg of bank, and time delay in the pilot's command path. Flight test data from the Concorde certification program are used to substantiate a number of the proposed design criteria.

Implementation of quality by design principles in the development of microsponges as drug delivery carriers: Identification and optimization of critical factors using multivariate statistical analyses and design of experiments studies.

PubMed

Simonoska Crcarevska, Maja; Dimitrovska, Aneta; Sibinovska, Nadica; Mladenovska, Kristina; Slavevska Raicki, Renata; Glavas Dodov, Marija

2015-07-15

Microsponges drug delivery system (MDDC) was prepared by double emulsion-solvent-diffusion technique using rotor-stator homogenization. Quality by design (QbD) concept was implemented for the development of MDDC with potential to be incorporated into semisolid dosage form (gel). Quality target product profile (QTPP) and critical quality attributes (CQA) were defined and identified, accordingly. Critical material attributes (CMA) and Critical process parameters (CPP) were identified using quality risk management (QRM) tool, failure mode, effects and criticality analysis (FMECA). CMA and CPP were identified based on results obtained from principal component analysis (PCA-X&Y) and partial least squares (PLS) statistical analysis along with literature data, product and process knowledge and understanding. FMECA identified amount of ethylcellulose, chitosan, acetone, dichloromethane, span 80, tween 80 and water ratio in primary/multiple emulsions as CMA and rotation speed and stirrer type used for organic solvent removal as CPP. The relationship between identified CPP and particle size as CQA was described in the design space using design of experiments - one-factor response surface method. Obtained results from statistically designed experiments enabled establishment of mathematical models and equations that were used for detailed characterization of influence of identified CPP upon MDDC particle size and particle size distribution and their subsequent optimization. Copyright © 2015 Elsevier B.V. All rights reserved.

Quality Tools and TRIZ Based Quality Improvement Case Study at PT ‘X’ A Plastic Moulding Manufacturing Industry

NASA Astrophysics Data System (ADS)

Wirawan, Christina; Chandra, Fory

2016-02-01

Theory of Inventive Problem Solving (TRIZ) is a creative encouraging problem solving method. TRIZ is prepared by Altshuller for product design. Altshuller prepared contradiction matrix and suggestion to solve contradictions usually occur in product design. This paper try to combine TRIZ with quality tools such as Pareto and Fault Tree Analysis (FTA) to solve contradiction in quality improvement problem, neither than product design problem. Pareto used to identify defect priority, FTA used to analysis and identify root cause of defect. When there is contradiction in solving defect causes, TRIZ used to find creative problem solving. As a case study, PT ’X’, a plastic molding manufacturing industry was taken. PT ‘X’ using traditional press machine to produce plastic thread cone. There are 5 defect types that might occur in plastic thread cone production, incomplete form, dirty, mottle, excessive form, rugged. Research about quality improvement effort using DMAIC at PT ‘X’ have been done by Fory Candra. From this research, defect types, priority, root cause from FTA, recommendation from FMEA. In this research, from FTA reviewed, contradictions found among causes troublesome quality improvement efforts. TRIZ used to solve the contradictions and quality improvement effort can be made effectively.

Data envelopment analysis in service quality evaluation: an empirical study

NASA Astrophysics Data System (ADS)

Najafi, Seyedvahid; Saati, Saber; Tavana, Madjid

2015-09-01

Service quality is often conceptualized as the comparison between service expectations and the actual performance perceptions. It enhances customer satisfaction, decreases customer defection, and promotes customer loyalty. Substantial literature has examined the concept of service quality, its dimensions, and measurement methods. We introduce the perceived service quality index (PSQI) as a single measure for evaluating the multiple-item service quality construct based on the SERVQUAL model. A slack-based measure (SBM) of efficiency with constant inputs is used to calculate the PSQI. In addition, a non-linear programming model based on the SBM is proposed to delineate an improvement guideline and improve service quality. An empirical study is conducted to assess the applicability of the method proposed in this study. A large number of studies have used DEA as a benchmarking tool to measure service quality. These models do not propose a coherent performance evaluation construct and consequently fail to deliver improvement guidelines for improving service quality. The DEA models proposed in this study are designed to evaluate and improve service quality within a comprehensive framework and without any dependency on external data.

Indoor Air Quality in 24 California Residences Designed as High-Performance Homes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Less, Brennan; Mullen, Nasim; Singer, Brett

2015-07-01

Today’s high performance green homes are reaching previously unheard of levels of airtightness and are using new materials, technologies and strategies, whose impacts on Indoor Air Quality (IAQ) cannot be fully anticipated from prior studies. This research study used pollutant measurements, home inspections, diagnostic testing and occupant surveys to assess IAQ in 24 new or deeply retrofitted homes designed to be high performance green buildings in California.

Better design quality of public toilets for visually impaired persons: an all-round concept in design for the promotion of health.

PubMed

Siu, Kin Wai Michael

2008-11-01

According to United Nations statistics, about one-thirtieth of the world's population is visually impaired. These visually impaired persons (VIPs) face a variety of difficulties in their daily lives. This is the case not only in countries with a shortage of resources or with relatively low living standards, but also in developed countries. Most of the time, such difficulties in daily life come from the misunderstanding of VIPs' wants and needs and in turn poor design quality. To enhance equal opportunities in society, promote public health and improve the design quality of the public environment and facilities, a project on how VIPs access public toilets has been under way since 2004. To maintain better design quality in public toilets, the FISH concept has been initiated. This design concept includes the design considerations of friendly, informative, safe, and hygienic. This paper reviews the wants and needs of VIPs that should be considered in using public toilets, and the help that they need to be given. Based on the findings of the project, this paper then discusses how better quality designs for public toilets to promote public health can be obtained by implementing FISH.

Design, implementation, and quality control in the Pathways American-Indian multicenter trial

PubMed Central

Stone, Elaine J.; Norman, James E.; Davis, Sally M.; Stewart, Dawn; Clay, Theresa E.; Caballero, Ben; Lohman, Timothy G.; Murray, David M.

2016-01-01

Background Pathways was the first multicenter American-Indian school-based study to test the effectiveness of an obesity prevention program promoting healthy eating and physical activity. Methods Pathways employed a nested cohort design in which 41 schools were randomized to intervention or control conditions and students within these schools were followed as a cohort (1,704 third graders at baseline). The study’s primary endpoint was percent body fat. Secondary endpoints were levels of fat in school lunches; time spent in physical activity; and knowledge, attitudes, and behaviors regarding diet and exercise. Quality control (QC) included design of data management systems which provided standardization and quality assurance of data collection and processing. Data QC procedures at study centers included manuals of operation, training and certification, and monitoring of performance. Process evaluation was conducted to monitor dose and fidelity of the interventions. Registration and tracking systems were used for students and schools. Results No difference in mean percent body fat at fifth grade was found between the intervention and control schools. Percent of calories from fat and saturated fat in school lunches was significantly reduced in the intervention schools as was total energy intake from 24-hour recalls. Significant increases in self-reported physical activity levels and knowledge of healthy behaviors were found for the intervention school students. Conclusions The Pathways study results provide evidence demonstrating the role schools can play in public health promotion. Its study design and QC systems and procedures provide useful models for other similar school based multi- or single-site studies. PMID:14636805

Nanosystem trends in drug delivery using quality-by-design concept.

PubMed

Li, Jing; Qiao, Yanjiang; Wu, Zhisheng

2017-06-28

Quality by design (QbD) has become an inevitable trend because of its benefits for product quality and process understanding. Trials have been conducted using QbD in nanosystems' optimization. This paper reviews the application of QbD for processing nanosystems and summarizes the application procedure. It provides prospective guidelines for future investigations that apply QbD to nanosystem manufacturing processes. Employing the QbD concept in this way is a novel area in nanosystem quality. Copyright © 2017 Elsevier B.V. All rights reserved.

Nurses' perceptions of feedback to nursing teams on quality measurements: An embedded case study design.

PubMed

Giesbers, A P M Suzanne; Schouteten, Roel L J; Poutsma, Erik; van der Heijden, Beatrice I J M; van Achterberg, Theo

2016-12-01

Providing nursing teams with feedback on quality measurements is used as a quality improvement instrument in healthcare organizations worldwide. Previous research indicated contradictory results regarding the effect of such feedback on both nurses' well-being and performance. Building on the Job Demands-Resources model this study explores: (1) whether and how nurses' perceptions of feedback on quality measurements (as a burdening job demand or rather as an intrinsically or extrinsically motivating job resource) are respectively related to nurses' well-being and performance; and (2) whether and how team reflection influences nurses' perceptions. An embedded case study. Four surgical wards within three different acute teaching-hospital settings in the Netherlands. During a period of four months, the nurses on each ward were provided with similar feedback on quality measurements. After this period, interviews with eight nurses and the ward manager for each ward were conducted. Additionally, observational data were collected from three oral feedback moments on each of the participating wards. The data revealed that individual nurses perceive the same feedback on quality measurements differently, leading to different effects on nurses' well-being and performance: 1) feedback can be perceived as a job demand that pressures nurses to improve the results on the quality measurements; 2) feedback can be perceived as an extrinsically motivating job resource, that is instrumental to improve the results on quality measurements; 3) feedback can be perceived as an intrinsically motivating job resource that stimulates nurses to improve the results on the quality measurements; and 4) feedback can be perceived neither as a job demand, nor as a job resource, and has no effect on nurses' well-being and performance. Additionally, this study indicates that team reflection after feedback seems to be very low in practice, while our data also provides evidence that nursing teams using the

An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine.

PubMed

Mishra, Saurabh M; Rohera, Bhagwan D

2017-11-01

The objective of the present study was to design and develop a formulation for orally disintegrating tablets (ODTs) of carbamazepine using quality by design principles. The target product profile (TPP) and quality target product profile (QTPP) of ODTs were identified. Risk assessment was carried out by leveraging prior knowledge and experience to define the criticality of factors based on their impact by Ishikawa fishbone diagram and preliminary hazard analysis tool. Box-Behnken response surface methodology was used to study the effect of critical factors on various attributes of ODTs. The independent factors selected were compression pressure (X 1 ), concentration of sublimating agent (volatile material) (X 2 ), disintegrant concentration (X 3 ) and the responses were tablet crushing strength, tablet porosity, disintegration time, water absorption time, tablet friability and drug dissolution. ANOVA and lack of fit test illustrated that selected independent variables had significant effect on the response variables, and excellent correlation was observed between actual and predicted values. Optimization by desirability function indicated that compression pressure, X 1 (1534 lbs), ammonium bicarbonate concentration, X 2 (7.68%) and Kollidon ® CL-SF concentration, X 3 (6%) were optimum to prepare ODT formulation of carbamazepine of desired attributes complying with QTPP. Thus, in the present study, a high level of assurance was established for ODT product quality and performance.

Extending cluster lot quality assurance sampling designs for surveillance programs.

PubMed

Hund, Lauren; Pagano, Marcello

2014-07-20

Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance on the basis of the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible nonparametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. Copyright © 2014 John Wiley & Sons, Ltd.

Clinical evaluation study of the German network of disorders of sex development (DSD)/intersexuality: study design, description of the study population, and data quality

PubMed Central

Lux, Anke; Kropf, Siegfried; Kleinemeier, Eva; Jürgensen, Martina; Thyen, Ute

2009-01-01

Background The German Network of Disorders of Sex Development (DSD)/Intersexuality carried out a large scale clinical evaluation study on quality of life, gender identity, treatment satisfaction, coping, and problems associated with diagnoses and therapies in individuals with disorders of sex development (DSD). DSD are a heterogeneous group of various genetic disorders of sex determination or sex differentiation, all of which are rare conditions. In about half of all cases the molecular genetic diagnosis is unknown and diagnosis rests on clinical features. Methods and design The multi-centre clinical evaluation study includes short-term follow-up in some and cross-sectional assessments in all age and diagnostic groups fitting the criteria of DSD. Recruitment was from January 2005 until December 2007 in whole Germany and, additionally, in 2007 in Austria and German-speaking Switzerland. The study consists of a psychosocial inquiry for children, adolescents and their parents, and adults with standardized instruments and the collection of DSD-specific medical data by the attending physician. The main goal was the description of clinical outcomes and the health-care situation of individuals with DSD using a broad generic definition of DSD including all conditions with a mismatch of chromosomal, gonadal and phenotypical sex. 439 children and adolescents, their parents and adults with DSD participated. Discussion The clinical evaluation study represents the most comprehensive study in this clinical field. The paper discusses the study protocol, the data management and data quality as well as the classification used, and it describes the study population. Given the lack of large datasets in rare conditions such as DSD and often biased results from small scale clinical case series, the study aims to generate concrete hypotheses for evidence-based guidelines, which should be tested in further studies. PMID:19383134

Monitoring air quality in mountains: Designing an effective network

USGS Publications Warehouse

Peterson, D.L.

2000-01-01

A quantitatively robust yet parsimonious air-quality monitoring network in mountainous regions requires special attention to relevant spatial and temporal scales of measurement and inference. The design of monitoring networks should focus on the objectives required by public agencies, namely: 1) determine if some threshold has been exceeded (e.g., for regulatory purposes), and 2) identify spatial patterns and temporal trends (e.g., to protect natural resources). A short-term, multi-scale assessment to quantify spatial variability in air quality is a valuable asset in designing a network, in conjunction with an evaluation of existing data and simulation-model output. A recent assessment in Washington state (USA) quantified spatial variability in tropospheric ozone distribution ranging from a single watershed to the western third of the state. Spatial and temporal coherence in ozone exposure modified by predictable elevational relationships ( 1.3 ppbv ozone per 100 m elevation gain) extends from urban areas to the crest of the Cascade Range. This suggests that a sparse network of permanent analyzers is sufficient at all spatial scales, with the option of periodic intensive measurements to validate network design. It is imperative that agencies cooperate in the design of monitoring networks in mountainous regions to optimize data collection and financial efficiencies.

Student-Designed River Study.

ERIC Educational Resources Information Center

Turkall, Sheila Florian

1996-01-01

Describes an integrated student-designed investigation in which students explore different aspects of the Chagrin River including the river ecosystem, velocity and average depth, river flooding, water quality, and economic and political factors. (JRH)

Conceptual design study of 1985 commercial tilt rotor transports. Volume 1: VTOL design summary

NASA Technical Reports Server (NTRS)

Detore, J. A.; Sambell, K. W.

1975-01-01

Aircraft were synthesized in the 21-, 45-, and 100- passenger categories. Technological factors were considered and the 45-passenger point design, designated the D312, was selected. Variants of the D312 having sideline noise levels in hover of + or - 5 PNdB were also studied. All three 45-passenger aircraft were analyzed for performance, weights, economics, handling qualities, noise footprints, aeroelastic stability and ride comfort. Results are presented.

Rating the methodological quality of single-subject designs and n-of-1 trials: introducing the Single-Case Experimental Design (SCED) Scale.

PubMed

Tate, Robyn L; McDonald, Skye; Perdices, Michael; Togher, Leanne; Schultz, Regina; Savage, Sharon

2008-08-01

Rating scales that assess methodological quality of clinical trials provide a means to critically appraise the literature. Scales are currently available to rate randomised and non-randomised controlled trials, but there are none that assess single-subject designs. The Single-Case Experimental Design (SCED) Scale was developed for this purpose and evaluated for reliability. Six clinical researchers who were trained and experienced in rating methodological quality of clinical trials developed the scale and participated in reliability studies. The SCED Scale is an 11-item rating scale for single-subject designs, of which 10 items are used to assess methodological quality and use of statistical analysis. The scale was developed and refined over a 3-year period. Content validity was addressed by identifying items to reduce the main sources of bias in single-case methodology as stipulated by authorities in the field, which were empirically tested against 85 published reports. Inter-rater reliability was assessed using a random sample of 20/312 single-subject reports archived in the Psychological Database of Brain Impairment Treatment Efficacy (PsycBITE). Inter-rater reliability for the total score was excellent, both for individual raters (overall ICC = 0.84; 95% confidence interval 0.73-0.92) and for consensus ratings between pairs of raters (overall ICC = 0.88; 95% confidence interval 0.78-0.95). Item reliability was fair to excellent for consensus ratings between pairs of raters (range k = 0.48 to 1.00). The results were replicated with two independent novice raters who were trained in the use of the scale (ICC = 0.88, 95% confidence interval 0.73-0.95). The SCED Scale thus provides a brief and valid evaluation of methodological quality of single-subject designs, with the total score demonstrating excellent inter-rater reliability using both individual and consensus ratings. Items from the scale can also be used as a checklist in the design, reporting and critical

Preliminary Quality Control System Design for the Pell Grant Program.

ERIC Educational Resources Information Center

Advanced Technology, Inc., Reston, VA.

A preliminary design for a quality control (QC) system for the Pell Grant Program is proposed, based on the needs of the Office of Student Financial Assistance (OSFA). The applicability of the general design for other student aid programs administered by OSFA is also considered. The following steps included in a strategic approach to QC system…

Detailed design of a Ride Quality Augmentation System for commuter aircraft

NASA Technical Reports Server (NTRS)

Suikat, Reiner; Donaldson, Kent E.; Downing, David R.

1989-01-01

The design of a Ride Quality Augmentation System (RQAS) for commuter aircraft is documented. The RQAS is designed for a Cessna 402B, an 8 passenger prop twin representative to this class of aircraft. The purpose of the RQAS is the reduction of vertical and lateral accelerations of the aircraft due to atmospheric turbulence by the application of active control. The detailed design of the hardware (the aircraft modifications, the Ride Quality Instrumentation System (RQIS), and the required computer software) is examined. The aircraft modifications, consisting of the dedicated control surfaces and the hydraulic actuation system, were designed at Cessna Aircraft by Kansas University-Flight Research Laboratory. The instrumentation system, which consist of the sensor package, the flight computer, a Data Acquisition System, and the pilot and test engineer control panels, was designed by NASA-Langley. The overall system design and the design of the software, both for flight control algorithms and ground system checkout are detailed. The system performance is predicted from linear simulation results and from power spectral densities of the aircraft response to a Dryden gust. The results indicate that both accelerations are possible.

Software Design Improvements. Part 2; Software Quality and the Design and Inspection Process

NASA Technical Reports Server (NTRS)

Lalli, Vincent R.; Packard, Michael H.; Ziemianski, Tom

1997-01-01

The application of assurance engineering techniques improves the duration of failure-free performance of software. The totality of features and characteristics of a software product are what determine its ability to satisfy customer needs. Software in safety-critical systems is very important to NASA. We follow the System Safety Working Groups definition for system safety software as: 'The optimization of system safety in the design, development, use and maintenance of software and its integration with safety-critical systems in an operational environment. 'If it is not safe, say so' has become our motto. This paper goes over methods that have been used by NASA to make software design improvements by focusing on software quality and the design and inspection process.

The quality estimation of exterior wall’s and window filling’s construction design

NASA Astrophysics Data System (ADS)

Saltykov, Ivan; Bovsunovskaya, Maria

2017-10-01

The article reveals the term of “artificial envelope” in dwelling building. Authors offer a complex multifactorial approach to the design quality estimation of external fencing structures, which is based on various parameters impact. These referred parameters are: functional, exploitation, cost, and also, the environmental index is among them. The quality design index Qк is inputting for the complex characteristic of observed above parameters. The mathematical relation of this index from these parameters is the target function for the quality design estimation. For instance, the article shows the search of optimal variant for wall and window designs in small, middle and large square dwelling premises of economic class buildings. The graphs of target function single parameters are expressed for the three types of residual chamber’s dimensions. As a result of the showing example, there is a choice of window opening’s dimensions, which make the wall’s and window’s constructions properly correspondent to the producible complex requirements. The authors reveal the comparison of recommended window filling’s square in accordance with the building standards, and the square, due to the finding of the optimal variant of the design quality index. The multifactorial approach for optimal design searching, which is mentioned in this article, can be used in consideration of various construction elements of dwelling buildings in accounting of suitable climate, social and economic construction area features.

Downstream processing from hot-melt extrusion towards tablets: A quality by design approach.

PubMed

Grymonpré, W; Bostijn, N; Herck, S Van; Verstraete, G; Vanhoorne, V; Nuhn, L; Rombouts, P; Beer, T De; Remon, J P; Vervaet, C

2017-10-05

Since the concept of continuous processing is gaining momentum in pharmaceutical manufacturing, a thorough understanding on how process and formulation parameters can impact the critical quality attributes (CQA) of the end product is more than ever required. This study was designed to screen the influence of process parameters and drug load during HME on both extrudate properties and tableting behaviour of an amorphous solid dispersion formulation using a quality-by-design (QbD) approach. A full factorial experimental design with 19 experiments was used to evaluate the effect of several process variables (barrel temperature: 160-200°C, screw speed: 50-200rpm, throughput: 0.2-0.5kg/h) and drug load (0-20%) as formulation parameter on the hot-melt extrusion (HME) process, extrudate and tablet quality of Soluplus ® -Celecoxib amorphous solid dispersions. A prominent impact of the formulation parameter on the CQA of the extrudates (i.e. solid state properties, moisture content, particle size distribution) and tablets (i.e. tabletability, compactibility, fragmentary behaviour, elastic recovery) was discovered. The resistance of the polymer matrix to thermo-mechanical stress during HME was confirmed throughout the experimental design space. In addition, the suitability of Raman spectroscopy as verification method for the active pharmaceutical ingredient (API) concentration in solid dispersions was evaluated. Incorporation of the Raman spectroscopy data in a PLS model enabled API quantification in the extrudate powders with none of the DOE-experiments resulting in extrudates with a CEL content deviating>3% of the label claim. This research paper emphasized that HME is a robust process throughout the experimental design space for obtaining amorphous glassy solutions and for tabletting of such formulations since only minimal impact of the process parameters was detected on the extrudate and tablet properties. However, the quality of extrudates and tablets can be optimized

Defining and improving quality management in Dutch diabetes care groups and outpatient clinics: design of the study.

PubMed

Campmans-Kuijpers, Marjo J E; Lemmens, Lidwien C; Baan, Caroline A; Gorter, Kees J; Groothuis, Jolanda; van Vuure, Klementine H; Rutten, Guy E H M

2013-04-05

Worldwide, the organisation of diabetes care is changing. As a result general practices and diabetes teams in hospitals are becoming part of new organisations in which multidisciplinary care programs are implemented. In the Netherlands, 97 diabetes care groups and 104 outpatient clinics are working with a diabetes care program. Both types of organisations aim to improve the quality of diabetes care. Therefore, it is essential to understand the comprehensive elements needed for optimal quality management at organisational level. This study aims to assess the current level of diabetes quality management in both care groups and outpatient clinics and its improvement after providing feedback on their quality management system and tailored support. This study is a before-after study with a one-year follow-up comparing the levels of quality management before and after an intervention to improve diabetes quality management. To assess the status of quality management, online questionnaires were developed based on current literature. They consist of six domains: organisation of care, multidisciplinary teamwork, patient centeredness, performance management, quality improvement policy and management strategies. Based on the questionnaires, respondents will receive feedback on their score in a radar diagram and an elucidating table. They will also be granted access to an online toolbox with instruments that proved to be effective in quality of care improvement and with practical examples. If requested, personal support in implementing these tools will be available. After one year quality management will be measured again using the same questionnaire. This study will reveal a nationwide picture of quality management in diabetes care groups and outpatient clinics in the Netherlands and evaluate the effect of offering tailored support. The operationalisation of quality management on organisational level may be of interest for other countries as well.

Application of a quality by design approach to the cell culture process of monoclonal antibody production, resulting in the establishment of a design space.

PubMed

Nagashima, Hiroaki; Watari, Akiko; Shinoda, Yasuharu; Okamoto, Hiroshi; Takuma, Shinya

2013-12-01

This case study describes the application of Quality by Design elements to the process of culturing Chinese hamster ovary cells in the production of a monoclonal antibody. All steps in the cell culture process and all process parameters in each step were identified by using a cause-and-effect diagram. Prospective risk assessment using failure mode and effects analysis identified the following four potential critical process parameters in the production culture step: initial viable cell density, culture duration, pH, and temperature. These parameters and lot-to-lot variability in raw material were then evaluated by process characterization utilizing a design of experiments approach consisting of a face-centered central composite design integrated with a full factorial design. Process characterization was conducted using a scaled down model that had been qualified by comparison with large-scale production data. Multivariate regression analysis was used to establish statistical prediction models for performance indicators and quality attributes; with these, we constructed contour plots and conducted Monte Carlo simulation to clarify the design space. The statistical analyses, especially for raw materials, identified set point values, which were most robust with respect to the lot-to-lot variability of raw materials while keeping the product quality within the acceptance criteria. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

Design of the data quality control system for the ALICE O2

NASA Astrophysics Data System (ADS)

von Haller, Barthélémy; Lesiak, Patryk; Otwinowski, Jacek; ALICE Collaboration

2017-10-01

ALICE (A Large Ion Collider Experiment) is the heavy-ion detector designed to study the physics of strongly interacting matter and the quark-gluon plasma at the CERN Large Hadron Collider (LHC). A major upgrade of the experiment is planned for 2019-20. In order to cope with a 100 times higher data rate and with the continuous readout of the Time Projection Chamber (TPC), it is necessary to upgrade the Online and Offline computing to a new common system called O2. The online Data Quality Monitoring (DQM) and the offline Quality Assurance (QA) are critical aspects of the data acquisition and reconstruction software chains. The former intends to provide shifters with precise and complete information in order to quickly identify and overcome problems while the latter aims at providing good quality data for physics analyses. DQM and QA typically involve the gathering of data, its distributed analysis by user-defined algorithms, the merging of the resulting objects and their visualization. This paper discusses the architecture and the design of the data Quality Control system that regroups the DQM and QA. In addition it presents the main design requirements and early results of a working prototype. A special focus is put on the merging of monitoring objects generated by the QC tasks. The merging is a crucial and challenging step of the O2 system, not only for QC but also for the calibration. Various scenarios and implementations have been made and large-scale tests carried out. This document presents the final results of this extensive work on merging. We conclude with the plan of work for the coming years that will bring the QC to production by 2019.

The QUALYOR (QUalité Osseuse LYon Orléans) study: a new cohort for non invasive evaluation of bone quality in postmenopausal osteoporosis. Rationale and study design.

PubMed

Chapurlat, Roland; Pialat, Jean-Baptiste; Merle, Blandine; Confavreux, Elisabeth; Duvert, Florence; Fontanges, Elisabeth; Khacef, Farida; Peres, Sylvie Loiseau; Schott, Anne-Marie; Lespessailles, Eric

2017-12-27

The diagnostic performance of densitometry is inadequate. New techniques of non-invasive evaluation of bone quality may improve fracture risk prediction. Testing the value of these techniques is the goal of the QUALYOR cohort. The bone mineral density (BMD) of postmenopausal women who sustain osteoporotic fracture is generally above the World Health Organization definition for osteoporosis. Therefore, new approaches to improve the detection of women at high risk for fracture are warranted. We have designed and recruited a new cohort to assess the predictive value of several techniques to assess bone quality, including high-resolution peripheral quantitative computerized tomography (HRpQCT), hip QCT, calcaneus texture analysis, and biochemical markers. We have enrolled 1575 postmenopausal women, aged at least 50, with an areal BMD femoral neck or lumbar spine T-score between - 1.0 and - 3.0. Clinical risk factors for fracture have been collected along with serum and blood samples. We describe the design of the QUALYOR study. Among these 1575 women, 80% were aged at least 60. The mean femoral neck T-score was - 1.6 and the mean lumbar spine T-score was -1.2. This cohort is currently being followed up. QUALYOR will provide important information on the relationship between bone quality variables and fracture risk in women with moderately decreased BMD.

Design Features for Internet-Based Quality of Life Instrument in Inflammatory Bowel Disease

PubMed Central

Jonsson, Jens

1999-01-01

The idea of enabling user interaction in an Internet-based quality of life application comes with intention to solve problems common for conventional ways of communicating with patients. Here we are presenting results of the feasibility study, which regarded design and introduction of new forms to acquire patient information. Imagesp1092-a

A quality by design approach to understand formulation and process variability in pharmaceutical melt extrusion processes.

PubMed

Patwardhan, Ketaki; Asgarzadeh, Firouz; Dassinger, Thomas; Albers, Jessica; Repka, Michael A

2015-05-01

In this study, the principles of quality by design (QbD) have been uniquely applied to a pharmaceutical melt extrusion process for an immediate release formulation with a low melting model drug, ibuprofen. Two qualitative risk assessment tools - Fishbone diagram and failure mode effect analysis - were utilized to strategically narrow down the most influential parameters. Selected variables were further assessed using a Plackett-Burman screening study, which was upgraded to a response surface design consisting of the critical factors to study the interactions between the study variables. In process torque, glass transition temperature (Tg ) of the extrudates, assay, dissolution and phase change were measured as responses to evaluate the critical quality attributes (CQAs) of the extrudates. The effect of each study variable on the measured responses was analysed using multiple regression for the screening design and partial least squares for the optimization design. Experimental limits for formulation and process parameters to attain optimum processing have been outlined. A design space plot describing the domain of experimental variables within which the CQAs remained unchanged was developed. A comprehensive approach for melt extrusion product development based on the QbD methodology has been demonstrated. Drug loading concentrations between 40- 48%w/w and extrusion temperature in the range of 90-130°C were found to be the most optimum. © 2015 Royal Pharmaceutical Society.

Quality by design approach of a pharmaceutical gel manufacturing process, part 1: determination of the design space.

PubMed

Rosas, Juan G; Blanco, Marcel; González, Josep M; Alcalá, Manel

2011-10-01

This work was conducted in the framework of a quality by design project involving the production of a pharmaceutical gel. Preliminary work included the identification of the quality target product profiles (QTPPs) from historical values for previously manufactured batches, as well as the critical quality attributes for the process (viscosity and pH), which were used to construct a D-optimal experimental design. The experimental design comprised 13 gel batches, three of which were replicates at the domain center intended to assess the reproducibility of the target process. The viscosity and pH models established exhibited very high linearity and negligible lack of fit (LOF). Thus, R(2) was 0.996 for viscosity and 0.975 for pH, and LOF was 0.53 for the former parameter and 0.84 for the latter. The process proved reproducible at the domain center. Water content and temperature were the most influential factors for viscosity, and water content and acid neutralized fraction were the most influential factors for pH. A desirability function was used to find the best compromise to optimize the QTPPs. The body of information was used to identify and define the design space for the process. A model capable of combining the two response variables into a single one was constructed to facilitate monitoring of the process. Copyright © 2011 Wiley-Liss, Inc.

Performance-Based Service Quality Model: An Empirical Study on Japanese Universities

ERIC Educational Resources Information Center

Sultan, Parves; Wong, Ho

2010-01-01

Purpose: This paper aims to develop and empirically test the performance-based higher education service quality model. Design/methodology/approach: The study develops 67-item instrument for measuring performance-based service quality with a particular focus on the higher education sector. Scale reliability is confirmed using the Cronbach's alpha.…

Assessing the Value of High-Quality Care for Work-Associated Carpal Tunnel Syndrome in a Large Integrated Health Care System: Study Design.

PubMed

Conlon, Craig; Asch, Steven; Hanson, Mark; Avins, Andrew; Levitan, Barbara; Roth, Carol; Robbins, Michael; Dworsky, Michael; Seabury, Seth; Nuckols, Teryl

2016-01-01

Little is known about quality of care for occupational health disorders, although it may affect worker health and workers' compensation costs. Carpal tunnel syndrome (CTS) is a common work-associated condition that causes substantial disability. To describe the design of a study that is assessing quality of care for work-associated CTS and associations with clinical outcomes and costs. Prospective observational study of 477 individuals with new workers' compensation claims for CTS without acute trauma who were treated at 30 occupational health clinics from 2011 to 2013 and followed for 18 months. Timing of key clinical events, adherence to 45 quality measures, changes in scores on the Boston Carpal Tunnel Questionnaire and 12-item Short Form Health Survey Version 2 (SF-12v2), and costs associated with medical care and disability. Two hundred sixty-seven subjects (56%) received a diagnosis of CTS and had claims filed around the first visit to occupational health, 104 (22%) received a diagnosis before that visit and claim, and 98 (21%) received a diagnosis or had claims filed after that visit. One hundred seventy-eight (37%) subjects had time off work, which started around the time of surgery in 147 (83%) cases and lasted a median of 41 days (interquartile range = 42 days). The timing of diagnosis varied, but time off work was generally short and related to surgery. If associations of quality of care with key medical, economic, and quality-of-life outcomes are identified for work-associated CTS, systematic efforts to evaluate and improve quality of medical care for this condition are warranted.

Quality of Austrian and Dutch Falls-Prevention Information: A Comparative Descriptive Study

ERIC Educational Resources Information Center

Schoberer, Daniela; Mijnarends, Donja M.; Fliedner, Monica; Halfens, Ruud J. G.; Lohrmann, Christa

2016-01-01

Objectives: The aim of this study was to evaluate and compare the quality of written patient information material available in Austrian and Dutch hospitals and nursing homes pertaining to falls prevention. Design: Comparative descriptive study design Setting: Hospitals and nursing homes in Austria and the Netherlands. Method: Written patient…

The OA System of College - - Design of the Teaching Quality Monitoring Subsystem

NASA Astrophysics Data System (ADS)

Wu, Hongjuan; Ying, Hong; Jiang, Youyi; Yan, Pei

According to the drawbacks of traditional teaching quality monitoring subsystems and based on the achievements of practical research in the teaching quality monitoring administration in College, this paper provides a design of overall structure of teaching quality monitoring subsystem, that is more suitable for colleges' management. This new system is endowed with the same features as .NET application programes: easy to extend, easy to maintain, flexible, convenient, and it let enterprises, students' parents and excellent graduates participate in teaching quality monitoring administration, have significant effect to ensure the quality of talent training in colleges.

Application of quality by design concept to develop a dual gradient elution stability-indicating method for cloxacillin forced degradation studies using combined mixture-process variable models.

PubMed

Zhang, Xia; Hu, Changqin

2017-09-08

Penicillins are typical of complex ionic samples which likely contain large number of degradation-related impurities (DRIs) with different polarities and charge properties. It is often a challenge to develop selective and robust high performance liquid chromatography (HPLC) methods for the efficient separation of all DRIs. In this study, an analytical quality by design (AQbD) approach was proposed for stability-indicating method development of cloxacillin. The structures, retention and UV characteristics rules of penicillins and their impurities were summarized and served as useful prior knowledge. Through quality risk assessment and screen design, 3 critical process parameters (CPPs) were defined, including 2 mixture variables (MVs) and 1 process variable (PV). A combined mixture-process variable (MPV) design was conducted to evaluate the 3 CPPs simultaneously and a response surface methodology (RSM) was used to achieve the optimal experiment parameters. A dual gradient elution was performed to change buffer pH, mobile-phase type and strength simultaneously. The design spaces (DSs) was evaluated using Monte Carlo simulation to give their possibility of meeting the specifications of CQAs. A Plackett-Burman design was performed to test the robustness around the working points and to decide the normal operating ranges (NORs). Finally, validation was performed following International Conference on Harmonisation (ICH) guidelines. To our knowledge, this is the first study of using MPV design and dual gradient elution to develop HPLC methods and improve separations for complex ionic samples. Copyright © 2017 Elsevier B.V. All rights reserved.

Benchmarking Potential Factors Leading to Education Quality: A Study of Cambodian Higher Education

ERIC Educational Resources Information Center

Chen, Ching-Yaw; Sok, Phyra; Sok, Keomony

2007-01-01

Purpose: To study the quality in higher education in Cambodia and explore the potential factors leading to quality in Cambodian higher education. Design/methodology/approach: Five main factors that were deemed relevant in providing quality in Cambodian higher education were proposed: academic curriculum and extra-curricular activities, teachers'…

Quality Market: Design and Field Study of Prediction Market for Software Quality Control

ERIC Educational Resources Information Center

Krishnamurthy, Janaki

2010-01-01

Given the increasing competition in the software industry and the critical consequences of software errors, it has become important for companies to achieve high levels of software quality. While cost reduction and timeliness of projects continue to be important measures, software companies are placing increasing attention on identifying the user…

Case study: survey of patient satisfaction with prosthesis quality and design among below-knee prosthetic leg socket users.

PubMed

Mohd Hawari, Nurhanisah; Jawaid, Mohammad; Md Tahir, Paridah; Azmeer, Raja Ahmad

2017-11-01

The aim of this case study was to explore patient satisfaction with the quality of prosthetic leg sockets intended for persons with lower limb amputations. A qualitative study based on in-depth interviews, preceded by a questionnaire session, was carried out with patients from the Rehabilitation Center and Hospital in Malaysia. Twelve out-patient and in-patient amputees with lower limb amputations, specifically below-knee amputations, were chosen randomly. The analysis of patients' narratives aimed to identify the functional and esthetic characteristics of currently used prosthetic leg sockets and any problems related to them. The obtained results indicated that out of the 12 participants, 41.7% and 25% were satisfied and somewhat satisfied with their current prosthetic sockets. Durability and comfort were rated by the participants as the most important characteristics of prosthetic sockets, with 83.3%. As regards the esthetic appearance of the socket, 66.7% of the respondents considered that the most important feature was the material from which the socket was fabricated. Thus, we conclude that current satisfaction levels with the quality of prosthetic sockets among amputees in Malaysia are suitable, prosthesis being preferred by many amputees. The results can be used to direct future research on cosmesis and functionality of prosthetic socket design. Implications for Rehabilitation Case study will help participants to get cost effective prosthetic leg socket. Develop prosthetic leg socket comfortable as comparative to existing one. Help Malaysian government to make policy to develop local prosthetic leg socket at affordable price.

Designing quality course management systems that foster intra-professional education.

PubMed

Bowers, Helen F

2006-12-01

This paper draws on the experiences of the author in designing and implementing quality course management policies and procedures for vocational and higher educational programs, both overseas and in Australia. In particular, the paper focuses on those programs of study that require practicums within the curriculum. Whether these are clinical nursing placements, physiotherapy hands-on practical blocks or teacher training instruction, there are many principles of adult education that can be applied to the design and development of course management systems that foster inter-professional education. It is important that the components of any such system allow for a multi-faceted approach that relates collaborative learning to collaborative practice and supports a team of professionals through the skilled use of group-based learning, interactive assessments and inter-organisational processes and practices. The term 'course management system' is used here to describe all those policies and procedures that form the framework of any higher education department or faculty that has the overall responsibility for developing curriculum, teaching and learning resources that ensure quality educational outcomes for its students. In these days of multi-skilling, the benefits of inter-professional education may be significant. To guarantee that standards are kept high and learning outcomes are achievable, the management of an educational system must cover many areas of professional practice. It needs to be supported by all stakeholders in the organisation so that there is an environment of understanding, good interpersonal communication, supportive inter-group relations and an atmosphere of professionalism that is pervasive. This paper introduces a third definition to the model and suggests that intra-professional education be added to form a tripartite foundation for quality professional learning outcomes.

Modal control theory and application to aircraft lateral handling qualities design

NASA Technical Reports Server (NTRS)

Srinathkumar, S.

1978-01-01

A multivariable synthesis procedure based on eigenvalue/eigenvector assignment is reviewed and is employed to develop a systematic design procedure to meet the lateral handling qualities design objectives of a fighter aircraft over a wide range of flight conditions. The closed loop modal characterization developed provides significant insight into the design process and plays a pivotal role in the synthesis of robust feedback systems. The simplicity of the synthesis algorithm yields an efficient computer aided interactive design tool for flight control system synthesis.

Relationship of Indoor, Outdoor and Personal Air (RIOPA) study: study design, methods and quality assurance/control results.

PubMed

Weisel, Clifford P; Zhang, Junfeng; Turpin, Barbara J; Morandi, Maria T; Colome, Steven; Stock, Thomas H; Spektor, Dalia M; Korn, Leo; Winer, Arthur; Alimokhtari, Shahnaz; Kwon, Jaymin; Mohan, Krishnan; Harrington, Robert; Giovanetti, Robert; Cui, William; Afshar, Masoud; Maberti, Silvia; Shendell, Derek

2005-03-01

The Relationship of Indoor, Outdoor and Personal Air (RIOPA) Study was undertaken to evaluate the contribution of outdoor sources of air toxics, as defined in the 1990 Clean Air Act Amendments, to indoor concentrations and personal exposures. The concentrations of 18 volatile organic compounds (VOCs), 17 carbonyl compounds, and fine particulate matter mass (PM(2.5)) were measured using 48-h outdoor, indoor and personal air samples collected simultaneously. PM2.5 mass, as well as several component species (elemental carbon, organic carbon, polyaromatic hydrocarbons and elemental analysis) were also measured; only PM(2.5) mass is reported here. Questionnaires were administered to characterize homes, neighborhoods and personal activities that might affect exposures. The air exchange rate was also measured in each home. Homes in close proximity (<0.5 km) to sources of air toxics were preferentially (2:1) selected for sampling. Approximately 100 non-smoking households in each of Elizabeth, NJ, Houston, TX, and Los Angeles, CA were sampled (100, 105, and 105 respectively) with second visits performed at 84, 93, and 81 homes in each city, respectively. VOC samples were collected at all homes, carbonyls at 90% and PM(2.5) at 60% of the homes. Personal samples were collected from nonsmoking adults and a portion of children living in the target homes. This manuscript provides the RIOPA study design and quality control and assurance data. The results from the RIOPA study can potentially provide information on the influence of ambient sources on indoor air concentrations and exposure for many air toxics and will furnish an opportunity to evaluate exposure models for these compounds.

Forward-Oriented Designing for Learning as a Means to Achieve Educational Quality

ERIC Educational Resources Information Center

Ghislandi, Patrizia M. M.; Raffaghelli, Juliana E.

2015-01-01

In this paper, we reflect on how Design for Learning can create the basis for a culture of educational quality. We explore the process of Design for Learning within a blended, undergraduate university course through a teacher-led inquiry approach, aiming at showing the connections between the process of Design for Learning and academic…

A Quality by Design approach to investigate tablet dissolution shift upon accelerated stability by multivariate methods.

PubMed

Huang, Jun; Goolcharran, Chimanlall; Ghosh, Krishnendu

2011-05-01

This paper presents the use of experimental design, optimization and multivariate techniques to investigate root-cause of tablet dissolution shift (slow-down) upon stability and develop control strategies for a drug product during formulation and process development. The effectiveness and usefulness of these methodologies were demonstrated through two application examples. In both applications, dissolution slow-down was observed during a 4-week accelerated stability test under 51°C/75%RH storage condition. In Application I, an experimental design was carried out to evaluate the interactions and effects of the design factors on critical quality attribute (CQA) of dissolution upon stability. The design space was studied by design of experiment (DOE) and multivariate analysis to ensure desired dissolution profile and minimal dissolution shift upon stability. Multivariate techniques, such as multi-way principal component analysis (MPCA) of the entire dissolution profiles upon stability, were performed to reveal batch relationships and to evaluate the impact of design factors on dissolution. In Application II, an experiment was conducted to study the impact of varying tablet breaking force on dissolution upon stability utilizing MPCA. It was demonstrated that the use of multivariate methods, defined as Quality by Design (QbD) principles and tools in ICH-Q8 guidance, provides an effective means to achieve a greater understanding of tablet dissolution upon stability. Copyright © 2010 Elsevier B.V. All rights reserved.

A design procedure for the handling qualities optimization of the X-29A aircraft

NASA Technical Reports Server (NTRS)

Bosworth, John T.; Cox, Timothy H.

1989-01-01

A design technique for handling qualities improvement was developed for the X-29A aircraft. As with any new aircraft, the X-29A control law designers were presented with a relatively high degree of uncertainty in their mathematical models. The presence of uncertainties, and the high level of static instability of the X-29A caused the control law designers to stress stability and robustness over handling qualities. During flight test, the mathematical models of the vehicle were validated or corrected to match the vehicle dynamic behavior. The updated models were then used to fine tune the control system to provide fighter-like handling characteristics. A design methodology was developed which works within the existing control system architecture to provide improved handling qualities and acceptable stability with a minimum of cost in both implementation as well as software verification and validation.

Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation.

PubMed

Monks, K; Molnár, I; Rieger, H-J; Bogáti, B; Szabó, E

2012-04-06

Robust HPLC separations lead to fewer analysis failures and better method transfer as well as providing an assurance of quality. This work presents the systematic development of an optimal, robust, fast UHPLC method for the simultaneous assay of two APIs of an eye drop sample and their impurities, in accordance with Quality by Design principles. Chromatography software is employed to effectively generate design spaces (Method Operable Design Regions), which are subsequently employed to determine the final method conditions and to evaluate robustness prior to validation. Copyright © 2011 Elsevier B.V. All rights reserved.

Cluster designs to assess the prevalence of acute malnutrition by lot quality assurance sampling: a validation study by computer simulation

PubMed Central

Olives, Casey; Pagano, Marcello; Deitchler, Megan; Hedt, Bethany L; Egge, Kari; Valadez, Joseph J

2009-01-01

Traditional lot quality assurance sampling (LQAS) methods require simple random sampling to guarantee valid results. However, cluster sampling has been proposed to reduce the number of random starting points. This study uses simulations to examine the classification error of two such designs, a 67×3 (67 clusters of three observations) and a 33×6 (33 clusters of six observations) sampling scheme to assess the prevalence of global acute malnutrition (GAM). Further, we explore the use of a 67×3 sequential sampling scheme for LQAS classification of GAM prevalence. Results indicate that, for independent clusters with moderate intracluster correlation for the GAM outcome, the three sampling designs maintain approximate validity for LQAS analysis. Sequential sampling can substantially reduce the average sample size that is required for data collection. The presence of intercluster correlation can impact dramatically the classification error that is associated with LQAS analysis. PMID:20011037

Cluster designs to assess the prevalence of acute malnutrition by lot quality assurance sampling: a validation study by computer simulation.

PubMed

Olives, Casey; Pagano, Marcello; Deitchler, Megan; Hedt, Bethany L; Egge, Kari; Valadez, Joseph J

2009-04-01

Traditional lot quality assurance sampling (LQAS) methods require simple random sampling to guarantee valid results. However, cluster sampling has been proposed to reduce the number of random starting points. This study uses simulations to examine the classification error of two such designs, a 67x3 (67 clusters of three observations) and a 33x6 (33 clusters of six observations) sampling scheme to assess the prevalence of global acute malnutrition (GAM). Further, we explore the use of a 67x3 sequential sampling scheme for LQAS classification of GAM prevalence. Results indicate that, for independent clusters with moderate intracluster correlation for the GAM outcome, the three sampling designs maintain approximate validity for LQAS analysis. Sequential sampling can substantially reduce the average sample size that is required for data collection. The presence of intercluster correlation can impact dramatically the classification error that is associated with LQAS analysis.

Quantifying the Impact of Feedstock Quality on the Design of Bioenergy Supply Chain Networks

DOE PAGES

Castillo-Villar, Krystel; Minor-Popocatl, Hertwin; Webb, Erin

2016-03-01

Logging residues, which refer to the unused portions of trees cut during logging, are important sources of biomass for the emerging biofuel industry and are critical feedstocks for the first-type biofuel facilities (e.g., corn-ethanol facilities). Logging residues are under-utilized sources of biomass for energetic purposes. To support the scaling-up of the bioenergy industry, it is essential to design cost-effective biofuel supply chains that not only minimize costs, but also consider the biomass quality characteristics. The biomass quality is heavily dependent upon the moisture and the ash contents. Ignoring the biomass quality characteristics and its intrinsic costs may yield substantial economicmore » losses that will only be discovered after operations at a biorefinery have begun. Here this paper proposes a novel bioenergy supply chain network design model that minimizes operational costs and includes the biomass quality-related costs. The proposed model is unique in the sense that it supports decisions where quality is not unrealistically assumed to be perfect. The effectiveness of the proposed methodology is proven by assessing a case study in the state of Tennessee, USA. The results demonstrate that the ash and moisture contents of logging residues affect the performance of the supply chain (in monetary terms). Higher-than-target moisture and ash contents incur in additional quality-related costs. The quality-related costs in the optimal solution (with final ash content of 1% and final moisture of 50%) account for 27% of overall supply chain cost. In conclusion, based on the numeral experimentation, the total supply chain cost increased 7%, on average, for each additional percent in the final ash content.« less

Quantifying the Impact of Feedstock Quality on the Design of Bioenergy Supply Chain Networks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Castillo-Villar, Krystel; Minor-Popocatl, Hertwin; Webb, Erin

Logging residues, which refer to the unused portions of trees cut during logging, are important sources of biomass for the emerging biofuel industry and are critical feedstocks for the first-type biofuel facilities (e.g., corn-ethanol facilities). Logging residues are under-utilized sources of biomass for energetic purposes. To support the scaling-up of the bioenergy industry, it is essential to design cost-effective biofuel supply chains that not only minimize costs, but also consider the biomass quality characteristics. The biomass quality is heavily dependent upon the moisture and the ash contents. Ignoring the biomass quality characteristics and its intrinsic costs may yield substantial economicmore » losses that will only be discovered after operations at a biorefinery have begun. Here this paper proposes a novel bioenergy supply chain network design model that minimizes operational costs and includes the biomass quality-related costs. The proposed model is unique in the sense that it supports decisions where quality is not unrealistically assumed to be perfect. The effectiveness of the proposed methodology is proven by assessing a case study in the state of Tennessee, USA. The results demonstrate that the ash and moisture contents of logging residues affect the performance of the supply chain (in monetary terms). Higher-than-target moisture and ash contents incur in additional quality-related costs. The quality-related costs in the optimal solution (with final ash content of 1% and final moisture of 50%) account for 27% of overall supply chain cost. In conclusion, based on the numeral experimentation, the total supply chain cost increased 7%, on average, for each additional percent in the final ash content.« less

Nicotinamide polymeric nanoemulsified systems: a quality-by-design case study for a sustained antimicrobial activity

PubMed Central

Zidan, Ahmed S; Ahmed, Osama AA; Aljaeid, Bader M

2016-01-01

Nicotinamide, the amide form of vitamin B3, was demonstrated to combat some of the antibiotic-resistant infections that are increasingly common around the world. The objective of this study was to thoroughly understand the formulation and process variabilities affecting the preparation of nicotinamide-loaded polymeric nanoemulsified particles. The quality target product profile and critical quality attributes of the proposed product were presented. Plackett–Burman screening design was employed to screen eight variables for their influences on the formulation’s critical characteristics. The formulations were prepared by an oil-in-water emulsification followed by solvent replacement. The prepared systems were characterized by entrapment capacity (EC), entrapment efficiency (EE), particle size, polydispersity index, zeta potential, transmission electron microscopy, Fourier transform infrared spectroscopy, differential scanning calorimetry, powder X-ray diffraction, in vitro drug release, and their antibacterial activity against bacterial scrums. EC, EE, particle size, polydispersity index, zeta potential, and percentage release in 24 hours were found to be in the range of 33.5%–68.8%, 53.1%–67.1%, 43.3–243.3 nm, 0.08–0.28, 9.5–53.3 mV, and 5.8%–22.4%, respectively. One-way analysis of variance and Pareto charts revealed that the experimental loadings of 2-hydroxypropyl-β-cyclodextrin and Eudragit® S100 were the most significant for their effects on nicotinamide EC and EE. Moreover, the polymeric nanoemulsified particles demonstrated a sustained release profile for nicotinamide. The Fourier transform infrared spectroscopy, differential scanning calorimetry, and X-ray diffraction demonstrated a significant interaction between the drug and 2-hydroxypropyl-β-cyclodextrin that might modulate the sustained release behavior. Furthermore, the formulations provided a sustained antibacterial activity that depended on nicotinamide-loading concentration

A design of wireless sensor networks for a power quality monitoring system.

PubMed

Lim, Yujin; Kim, Hak-Man; Kang, Sanggil

2010-01-01

Power grids deal with the business of generation, transmission, and distribution of electric power. Recently, interest in power quality in electrical distribution systems has increased rapidly. In Korea, the communication network to deliver voltage, current, and temperature measurements gathered from pole transformers to remote monitoring centers employs cellular mobile technology. Due to high cost of the cellular mobile technology, power quality monitoring measurements are limited and data gathering intervals are large. This causes difficulties in providing the power quality monitoring service. To alleviate the problems, in this paper we present a communication infrastructure to provide low cost, reliable data delivery. The communication infrastructure consists of wired connections between substations and monitoring centers, and wireless connections between pole transformers and substations. For the wireless connection, we employ a wireless sensor network and design its corresponding data forwarding protocol to improve the quality of data delivery. For the design, we adopt a tree-based data forwarding protocol in order to customize the distribution pattern of the power quality information. We verify the performance of the proposed data forwarding protocol quantitatively using the NS-2 network simulator.

Ensuring the Quality of Evidence: Using the Best Design to Answer Health IT Questions.

PubMed

Weir, Charlene R

2016-01-01

The quality of logic in a research design determines the value of the results and our confidence regarding the validity of the findings. The purpose of this contribution is to review the principles of research design as they apply to research and evaluation in health IT. We review the architecture of research design, the definitions of cause, sources of bias and confounds, and the importance of measurement as related to the various types of health IT questions. The goal is to provide practitioners a roadmap for making decisions for their own specific study. The contribution is organized around the Threats to Validity taxonomy and explains how different design models address these threats through the use of blocking, factorial design, control groups and time series analysis. The contribution discusses randomized experiments, and includes regression discontinuity designs and various quasi-experimental designs with a special emphasis on how to improve pre/post designs. At the end, general recommendations are provided for improving weaker designs and general research procedures.

Designing a Clinical Data Warehouse Architecture to Support Quality Improvement Initiatives.

PubMed

Chelico, John D; Wilcox, Adam B; Vawdrey, David K; Kuperman, Gilad J

2016-01-01

Clinical data warehouses, initially directed towards clinical research or financial analyses, are evolving to support quality improvement efforts, and must now address the quality improvement life cycle. In addition, data that are needed for quality improvement often do not reside in a single database, requiring easier methods to query data across multiple disparate sources. We created a virtual data warehouse at NewYork Presbyterian Hospital that allowed us to bring together data from several source systems throughout the organization. We also created a framework to match the maturity of a data request in the quality improvement life cycle to proper tools needed for each request. As projects progress in the Define, Measure, Analyze, Improve, Control stages of quality improvement, there is a proper matching of resources the data needs at each step. We describe the analysis and design creating a robust model for applying clinical data warehousing to quality improvement.

DATA QUALITY OBJECTIVES AND STATISTICAL DESIGN SUPPORT FOR DEVELOPMENT OF A MONITORING PROTOCOL FOR RECREATIONAL WATERS

EPA Science Inventory

The purpose of this report is to describe the outputs of the Data Quality Objectives (DQOs) Process and discussions about developing a statistical design that will be used to implement the research study of recreational beach waters.

[Application of quality by design in granulation process for ginkgo leaf tablet (Ⅱ)： identification of critical quality attributes].

PubMed

Xu, Bing; Cui, Xiang-Long; Yang, Chan; Wang, Xin; Shi, Xin-Yuan; Qiao, Yan-Jiang

2017-03-01

Quality by design (QbD) highlights the concept of "begin with the end", which means to thoroughly understand the target product quality first, and then guide pharmaceutical process development and quality control throughout the whole manufacturing process. In this paper, the Ginkgo biloba granules intermediates were taken as the research object, and the requirements of the tensile strength of tablets were treated as the goals to establish the methods for identification of granules' critical quality attributes (CQAs) and establishment of CQAs' limits. Firstly, the orthogonal partial least square (OPLS) model was adopted to build the relationship between the micromeritic properties of 29 batches of granules and the tensile strength of ginkgo leaf tablets, and thereby the potential critical quality attributes (pCQAs) were screened by variable importance in the projection (VIP) indexes. Then, a series of OPLS models were rebuilt by reducing pCQAs variables one by one in view of the rule of VIP values from low to high in sequence. The model performance results demonstrated that calibration and predictive performance of the model had no decreasing trend after variables reduction. In consideration of the results from variables selection as well as the collinearity test and testability of the pCQAs, the median particle size (D₅₀) and the bulk density (Da) were identified as critical quality attributes (CQAs). The design space of CQAs was developed based on a multiple linear regression model established between the CQAs (D₅₀ and Da) and the tensile strength. The control constraints of the CQAs were determined as 170 μm< D₅₀<500 μm and 0.30 g•cm⁻³design space, which provided a basis for controlling and optimizing the wet granulation process of the ginkgo leaf tablet.. Copyright© by the Chinese Pharmaceutical Association.

Visualization of regulations to support design and quality control--a long-term study.

PubMed

Blomé, Mikael

2012-01-01

The aim of the study was to visualize design regulations of furniture by means of interactive technology based on earlier studies and practical examples. The usage of the visualized regulations was evaluated on two occasions: at the start when the first set of regulations was presented, and after six years of usage of all regulations. The visualized regulations were the result of a design process involving experts and potential users in collaboration with IKEA of Sweden AB. The evaluations by the different users showed a very positive response to using visualized regulations. The participative approach, combining expertise in specific regulations with visualization of guidelines, resulted in clear presentations of important regulations, and great attitudes among the users. These kinds of visualizations have proved to be applicable in a variety of product areas at IKEA, with a potential for further dissemination. It is likely that the approaches to design and visualized regulations in this case study could function in other branches.

Incorporating Measures of Sleep Quality into Cancer Studies

PubMed Central

Redeker, Nancy S.; Pigeon, Wilfred R.; Boudreau, Eilis A.

2014-01-01

Introduction/background Sleep disturbance may influence the development of cancer and responses to treatment. It is also closely tied to recovery and quality of life in cancer patients, survivors, and caregivers, and recent studies have begun to show beneficial effects of sleep promoting interventions. Despite the importance of sleep to cancer and its treatment and the availability of numerous tools for measuring sleep quality and quantity, sleep measurements are underutilized in cancer studies. Methods This review, written for cancer researchers interested in incorporating sleep measures into their studies, is designed to raise awareness about the importance of sleep and suggest strategies for including sleep evaluation in cancer studies. Conclusions Inclusion of readily available sleep measures may ultimately improve cancer care by facilitating studies that lead to a greater understanding of how sleep and sleep disturbance influence all aspects of cancer care and the patient experience. PMID:25510361

Design and methods of the Midwest Stream Quality Assessment (MSQA), 2013

USGS Publications Warehouse

Garrett, Jessica D.; Frey, Jeffrey W.; Van Metre, Peter C.; Journey, Celeste A.; Nakagaki, Naomi; Button, Daniel T.; Nowell, Lisa H.

2017-10-18

During 2013, the U.S. Geological Survey (USGS) National Water-Quality Assessment Project (NAWQA), in collaboration with the USGS Columbia Environmental Research Center, the U.S. Environmental Protection Agency (EPA) National Rivers and Streams Assessment (NRSA), and the EPA Office of Pesticide Programs assessed stream quality across the Midwestern United States. This Midwest Stream Quality Assessment (MSQA) simultaneously characterized watershed and stream-reach water-quality stressors along with instream biological conditions, to better understand regional stressor-effects relations. The MSQA design focused on effects from the widespread agriculture in the region and urban development because of their importance as ecological stressors of particular concern to Midwest region resource managers.A combined random stratified selection and a targeted selection based on land-use data were used to identify and select sites representing gradients in agricultural intensity across the region. During a 14-week period from May through August 2013, 100 sites were selected and sampled 12 times for contaminants, nutrients, and sediment. This 14-week water-quality “index” period culminated with an ecological survey of habitat, periphyton, benthic macroinvertebrates, and fish at all sites. Sediment was collected during the ecological survey for analysis of sediment chemistry and toxicity testing. Of the 100 sites, 50 were selected for the MSQA random stratified group from 154 NRSA sites planned for the region, and the other 50 MSQA sites were selected as targeted sites to more evenly cover agricultural and urban stressor gradients in the study area. Of the 50 targeted sites, 12 were in urbanized watersheds and 21 represented “good” biological conditions or “least disturbed” conditions. The remaining 17 targeted sites were selected to improve coverage of the agricultural intensity gradient or because of historical data collection to provide temporal context for the

Quality control and quality assurance in genotypic data for genome-wide association studies

PubMed Central

Laurie, Cathy C.; Doheny, Kimberly F.; Mirel, Daniel B.; Pugh, Elizabeth W.; Bierut, Laura J.; Bhangale, Tushar; Boehm, Frederick; Caporaso, Neil E.; Cornelis, Marilyn C.; Edenberg, Howard J.; Gabriel, Stacy B.; Harris, Emily L.; Hu, Frank B.; Jacobs, Kevin; Kraft, Peter; Landi, Maria Teresa; Lumley, Thomas; Manolio, Teri A.; McHugh, Caitlin; Painter, Ian; Paschall, Justin; Rice, John P.; Rice, Kenneth M.; Zheng, Xiuwen; Weir, Bruce S.

2011-01-01

Genome-wide scans of nucleotide variation in human subjects are providing an increasing number of replicated associations with complex disease traits. Most of the variants detected have small effects and, collectively, they account for a small fraction of the total genetic variance. Very large sample sizes are required to identify and validate findings. In this situation, even small sources of systematic or random error can cause spurious results or obscure real effects. The need for careful attention to data quality has been appreciated for some time in this field, and a number of strategies for quality control and quality assurance (QC/QA) have been developed. Here we extend these methods and describe a system of QC/QA for genotypic data in genome-wide association studies. This system includes some new approaches that (1) combine analysis of allelic probe intensities and called genotypes to distinguish gender misidentification from sex chromosome aberrations, (2) detect autosomal chromosome aberrations that may affect genotype calling accuracy, (3) infer DNA sample quality from relatedness and allelic intensities, (4) use duplicate concordance to infer SNP quality, (5) detect genotyping artifacts from dependence of Hardy-Weinberg equilibrium (HWE) test p-values on allelic frequency, and (6) demonstrate sensitivity of principal components analysis (PCA) to SNP selection. The methods are illustrated with examples from the ‘Gene Environment Association Studies’ (GENEVA) program. The results suggest several recommendations for QC/QA in the design and execution of genome-wide association studies. PMID:20718045

Quality by Design (QbD) Approach for Development of Co-Processed Excipient Pellets (MOMLETS) By Extrusion-Spheronization Technique.

PubMed

Patel, Hetal; Patel, Kishan; Tiwari, Sanjay; Pandey, Sonia; Shah, Shailesh; Gohel, Mukesh

2016-01-01

Microcrystalline cellulose (MCC) is an excellent excipient for the production of pellets by extrusion spheronization. However, it causes slow release rate of poorly water soluble drugs from pellets. Co-processed excipient prepared by spray drying (US4744987; US5686107; WO2003051338) and coprecipitation technique (WO9517831) are patented. The objective of present study was to develop co-processed MCC pellets (MOMLETS) by extrusion-spheronization technique using the principle of Quality by Design (QbD). Co-processed excipient core pellets (MOMLETS) were developed by extrusion spheronization technique using Quality by Design (QbD) approach. BCS class II drug (telmisartan) was layered onto it in a fluidized bed processor. Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA) for pellets were identified. Risk assessment was reported using Ishikawa diagram. Plackett Burman design was used to check the effect of seven independent variables; superdisintegrant, extruder speed, ethanol: water, spheronizer speed, extruder screen, pore former and MCC: lactose; on percentage drug release at 30 min. Pareto chart and normal probability plot was constructed to identify the significant factors. Box-Behnken design (BBD) using three most significant factors (Extruder screen size, type of superdisintegrant and type of pore former) was used as an optimization design. The control space was identified in which desired quality of the pellets can be obtained. Co-processed excipient core pellets (MOMLETS) were successfully developed by QbD approach. Versatility, Industrial scalability and simplicity are the main features of the proposed research. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Value of information analysis for groundwater quality monitoring network design Case study: Eocene Aquifer, Palestine

NASA Astrophysics Data System (ADS)

Khader, A.; McKee, M.

2010-12-01

Value of information (VOI) analysis evaluates the benefit of collecting additional information to reduce or eliminate uncertainty in a specific decision-making context. It makes explicit any expected potential losses from errors in decision making due to uncertainty and identifies the “best” information collection strategy as one that leads to the greatest expected net benefit to the decision-maker. This study investigates the willingness to pay for groundwater quality monitoring in the Eocene Aquifer, Palestine, which is an unconfined aquifer located in the northern part of the West Bank. The aquifer is being used by 128,000 Palestinians to fulfill domestic and agricultural demands. The study takes into account the consequences of pollution and the options the decision maker might face. Since nitrate is the major pollutant in the aquifer, the consequences of nitrate pollution were analyzed, which mainly consists of the possibility of methemoglobinemia (blue baby syndrome). In this case, the value of monitoring was compared to the costs of treating for methemoglobinemia or the costs of other options like water treatment, using bottled water or importing water from outside the aquifer. And finally, an optimal monitoring network that takes into account the uncertainties in recharge (climate), aquifer properties (hydraulic conductivity), pollutant chemical reaction (decay factor), and the value of monitoring is designed by utilizing a sparse Bayesian modeling algorithm called a relevance vector machine.

Evaluation of feedback interventions for improving the quality assurance of cancer screening in Japan: study design and report of the baseline survey.

PubMed

Machii, Ryoko; Saika, Kumiko; Higashi, Takahiro; Aoki, Ayako; Hamashima, Chisato; Saito, Hiroshi

2012-02-01

The importance of quality assurance in cancer screening has recently gained increasing attention in Japan. To evaluate and improve quality, checklists and process indicators have been developed. To explore effective methods of enhancing quality in cancer screening, we started a randomized control study of the methods of evaluation and feedback for cancer control from 2009 to 2014. We randomly assigned 1270 municipal governments, equivalent to 71% of all Japanese municipal governments that performed screening programs, into three groups. The high-intensity intervention groups (n = 425) were individually evaluated using both checklist performance and process indicator values, while the low-intensity intervention groups (n= 421) were individually evaluated on the basis of only checklist performance. The control group (n = 424) received only a basic report that included the national average of checklist performance scores. We repeated the survey for each municipality's quality assurance activity performance using checklists and process indicators. In this paper, we report our study design and the result of the baseline survey. The checklist adherence rates were especially low in the checklist elements related to invitation of individuals, detailed monitoring of process indicators such as cancer detection rates according to screening histories and appropriate selection of screening facilities. Screening rate and percentage of examinees who underwent detailed examination tended to be lower for large cities when compared with smaller cities for all cancer sites. The performance of the Japanese cancer screening program in 2009 was identified for the first time.

Eco-innovative design approach: Integrating quality and environmental aspects in prioritizing and solving engineering problems

NASA Astrophysics Data System (ADS)

Chakroun, Mahmoud; Gogu, Grigore; Pacaud, Thomas; Thirion, François

2014-09-01

This study proposes an eco-innovative design process taking into consideration quality and environmental aspects in prioritizing and solving technical engineering problems. This approach provides a synergy between the Life Cycle Assessment (LCA), the nonquality matrix, the Theory of Inventive Problem Solving (TRIZ), morphological analysis and the Analytical Hierarchy Process (AHP). In the sequence of these tools, LCA assesses the environmental impacts generated by the system. Then, for a better consideration of environmental aspects, a new tool is developed, the non-quality matrix, which defines the problem to be solved first from an environmental point of view. The TRIZ method allows the generation of new concepts and contradiction resolution. Then, the morphological analysis offers the possibility of extending the search space of solutions in a design problem in a systematic way. Finally, the AHP identifies the promising solution(s) by providing a clear logic for the choice made. Their usefulness has been demonstrated through their application to a case study involving a centrifugal spreader with spinning discs.

A design procedure and handling quality criteria for lateral directional flight control systems

NASA Technical Reports Server (NTRS)

Stein, G.; Henke, A. H.

1972-01-01

A practical design procedure for aircraft augmentation systems is described based on quadratic optimal control technology and handling-quality-oriented cost functionals. The procedure is applied to the design of a lateral-directional control system for the F4C aircraft. The design criteria, design procedure, and final control system are validated with a program of formal pilot evaluation experiments.

Designing a Clinical Data Warehouse Architecture to Support Quality Improvement Initiatives

PubMed Central

Chelico, John D.; Wilcox, Adam B.; Vawdrey, David K.; Kuperman, Gilad J.

2016-01-01

Clinical data warehouses, initially directed towards clinical research or financial analyses, are evolving to support quality improvement efforts, and must now address the quality improvement life cycle. In addition, data that are needed for quality improvement often do not reside in a single database, requiring easier methods to query data across multiple disparate sources. We created a virtual data warehouse at NewYork Presbyterian Hospital that allowed us to bring together data from several source systems throughout the organization. We also created a framework to match the maturity of a data request in the quality improvement life cycle to proper tools needed for each request. As projects progress in the Define, Measure, Analyze, Improve, Control stages of quality improvement, there is a proper matching of resources the data needs at each step. We describe the analysis and design creating a robust model for applying clinical data warehousing to quality improvement. PMID:28269833

Quality Control for Interviews to Obtain Dietary Recalls from Children for Research Studies

PubMed Central

SHAFFER, NICOLE M.; THOMPSON, WILLIAM O.; BAGLIO, MICHELLE L.; GUINN, CAROLINE H.; FRYE, FRANCESCA H. A.

2005-01-01

Quality control is an important aspect of a study because the quality of data collected provides a foundation for the conclusions drawn from the study. For studies that include interviews, establishing quality control for interviews is critical in ascertaining whether interviews are conducted according to protocol. Despite the importance of quality control for interviews, few studies adequately document the quality control procedures used during data collection. This article reviews quality control for interviews and describes methods and results of quality control for interviews from two of our studies regarding the accuracy of children's dietary recalls; the focus is on quality control regarding interviewer performance during the interview, and examples are provided from studies with children. For our two studies, every interview was audio recorded and transcribed. The audio recording and typed transcript from one interview conducted by each research dietitian either weekly or daily were randomly selected and reviewed by another research dietitian, who completed a standardized quality control for interviews checklist. Major strengths of the methods of quality control for interviews in our two studies include: (a) interviews obtained for data collection were randomly selected for quality control for interviews, and (b) quality control for interviews was assessed on a regular basis throughout data collection. The methods of quality control for interviews described may help researchers design appropriate methods of quality control for interviews for future studies. PMID:15389417

Case-Cohort Studies: Design and Applicability to Hand Surgery.

PubMed

Vojvodic, Miliana; Shafarenko, Mark; McCabe, Steven J

2018-04-24

Observational studies are common research strategies in hand surgery. The case-cohort design offers an efficient and resource-friendly method for risk assessment and outcomes analysis. Case-cohorts remain underrepresented in upper extremity research despite several practical and economic advantages over case-control studies. This report outlines the purpose, utility, and structure of the case-cohort design and offers a sample research question to demonstrate its value to risk estimation for adverse surgical outcomes. The application of well-designed case-cohort studies is advocated in an effort to improve the quality and quantity of observational research evidence in hand and upper extremity surgery. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Redesigning Design: Field Testing a Revised Design Rubric Based on iNACOL Quality Course Standards

ERIC Educational Resources Information Center

Adelstein, David; Barbour, Michael K.

2016-01-01

Designers have a limited selection of K-12 online course creation standards to choose from that are not blocked behind proprietary or pay walls. For numerous institutions and states, the use of the iNACOL "National Standards for Quality Online Courses" is becoming a widely used resource. This article presents the final phase in a…

Quality by design (QbD), Process Analytical Technology (PAT), and design of experiment applied to the development of multifunctional sunscreens.

PubMed

Peres, Daniela D'Almeida; Ariede, Maira Bueno; Candido, Thalita Marcilio; de Almeida, Tania Santos; Lourenço, Felipe Rebello; Consiglieri, Vladi Olga; Kaneko, Telma Mary; Velasco, Maria Valéria Robles; Baby, André Rolim

2017-02-01

Multifunctional formulations are of great importance to ensure better skin protection from harm caused by ultraviolet radiation (UV). Despite the advantages of Quality by Design and Process Analytical Technology approaches to the development and optimization of new products, we found in the literature only a few studies concerning their applications in cosmetic product industry. Thus, in this research work, we applied the QbD and PAT approaches to the development of multifunctional sunscreens containing bemotrizinol, ethylhexyl triazone, and ferulic acid. In addition, UV transmittance method was applied to assess qualitative and quantitative critical quality attributes of sunscreens using chemometrics analyses. Linear discriminant analysis allowed classifying unknown formulations, which is useful for investigation of counterfeit and adulteration. Simultaneous quantification of ethylhexyl triazone, bemotrizinol, and ferulic acid presented at the formulations was performed using PLS regression. This design allowed us to verify the compounds in isolation and in combination and to prove that the antioxidant action of ferulic acid as well as the sunscreen actions, since the presence of this component increased 90% of antioxidant activity in vitro.

A hingeless rotor XV-15 design integration feasibility study. Volume 1: Engineering design studies

NASA Technical Reports Server (NTRS)

Magee, J. P.; Alexander, H. R.

1978-01-01

A design integration feasibility study was carried out to investigate what modifications to the basic XV-15 were necessary to accomplish a flight demonstration of the XV-15 with a Boeing hingeless rotor. Also investigated were additional modifications which would exploit the full capability provided by the combination of the new rotor and the existing T53 engine. An evaluation of the aircraft is presented and the data indicate improved air vehicle performance, acceptable aeroelastic margins, lower noise levels and improved flying qualities compared with the XV-15 aircraft. Inspection of the rotor system data provided shows an essentially unlimited life rotor for the flight spectrum anticipated for the XV-15.

Quality assurance in non-interventional studies.

PubMed

Theobald, Karlheinz; Capan, Müge; Herbold, Marlis; Schinzel, Stefan; Hundt, Ferdinand

2009-11-09

Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres - in between 2% and 5% of the centres depending on the number of participating centres. Before start of

Quality assurance in non-interventional studies

PubMed Central

Theobald, Karlheinz; Capan, Müge; Herbold, Marlis; Schinzel, Stefan; Hundt, Ferdinand

2009-01-01

Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres – in between 2% and 5% of the centres depending on the number of participating centres. Before start

76 FR 6056 - Additional Air Quality Designations for the 2006 24-Hour Fine Particle National Ambient Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

...-9261-3] RIN 2060-AQ30 Additional Air Quality Designations for the 2006 24-Hour Fine Particle National..., and Decisions Related to the 1997 Air Quality Designations and Classifications for the Annual Fine... nationwide for all but three areas for the 2006 24-hour fine particle (PM 2.5 ) National Ambient Air Quality...

Rational design of high-yield and superior-quality rice.

PubMed

Zeng, Dali; Tian, Zhixi; Rao, Yuchun; Dong, Guojun; Yang, Yaolong; Huang, Lichao; Leng, Yujia; Xu, Jie; Sun, Chuan; Zhang, Guangheng; Hu, Jiang; Zhu, Li; Gao, Zhenyu; Hu, Xingming; Guo, Longbiao; Xiong, Guosheng; Wang, Yonghong; Li, Jiayang; Qian, Qian

2017-03-20

Rice (Oryza sativa L.) is a staple food for more than half of the world's population. To meet the ever-increasing demand for food, because of population growth and improved living standards, world rice production needs to double by 2030 1 . The development of new elite rice varieties with high yield and superior quality is challenging for traditional breeding approaches, and new strategies need to be developed. Here, we report the successful development of new elite varieties by pyramiding major genes that significantly contribute to grain quality and yield from three parents over five years. The new varieties exhibit higher yield potential and better grain quality than their parental varieties and the China's leading super-hybrid rice, Liang-you-pai-jiu (LYP9 or Pei-ai 64S/93-11). Our results demonstrate that rational design is a powerful strategy for meeting the challenges of future crop breeding, particularly in pyramiding multiple complex traits.

The quality of the evidence base for clinical pathway effectiveness: room for improvement in the design of evaluation trials.

PubMed

Rotter, Thomas; Kinsman, Leigh; James, Erica; Machotta, Andreas; Steyerberg, Ewout W

2012-06-18

The purpose of this article is to report on the quality of the existing evidence base regarding the effectiveness of clinical pathway (CPW) research in the hospital setting. The analysis is based on a recently published Cochrane review of the effectiveness of CPWs. An integral component of the review process was a rigorous appraisal of the methodological quality of published CPW evaluations. This allowed the identification of strengths and limitations of the evidence base for CPW effectiveness. We followed the validated Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria for randomized and non-randomized clinical pathway evaluations. In addition, we tested the hypotheses that simple pre-post studies tend to overestimate CPW effects reported. Out of the 260 primary studies meeting CPW content criteria, only 27 studies met the EPOC study design criteria, with the majority of CPW studies (more than 70 %) excluded from the review on the basis that they were simple pre-post evaluations, mostly comparing two or more annual patient cohorts. Methodologically poor study designs are often used to evaluate CPWs and this compromises the quality of the existing evidence base. Cochrane EPOC methodological criteria, including the selection of rigorous study designs along with detailed descriptions of CPW development and implementation processes, are recommended for quantitative evaluations to improve the evidence base for the use of CPWs in hospitals.

Ride quality criteria and the design process. [standards for ride comfort

NASA Technical Reports Server (NTRS)

Ravera, R. J.

1975-01-01

Conceptual designs for advanced ground transportation systems often hinge on obtaining acceptable vehicle ride quality while attempting to keep the total guideway cost (initial and subsequent maintenance) as low as possible. Two ride quality standards used extensively in work sponsored by the U.S. Department of Transportation (DOT) are the DOT-Urban Tracked Air Cushion Vehicle (UTACV) standard and the International Standards Organization (ISO) reduced ride comfort criteria. These standards are reviewed and some of the deficiencies, which become apparent when trying to apply them in practice, are noted. Through the use of a digital simulation, the impact of each of these standards on an example design process is examined. It is shown that meeting the ISO specification for the particular vehicle/guideway case investigated is easier than meeting the UTACV standard.

Re-design of apple pia packaging using quality function deployment method

NASA Astrophysics Data System (ADS)

Pulungan, M. H.; Nadira, N.; Dewi, I. A.

2018-03-01

This study was aimed to identify the attributes for premium apple pia packaging, to determine the technical response to be carried out by Permata Agro Mandiri Small and Medium Enterprise (SME) and to design a new apple pie packaging acceptable by the SME. The Quality Function Deployment (QFD) method was employed to improve the apple pia packaging design, which consisted of seven stages in data analysis. The results indicated that whats attribute required by the costumers include graphic design, dimensions, capacity, shape, strength, and resistance of packaging. While, the technical responses to be conducted by the SMEs were as follows: attractive visual packaging designs, attractive colors, clear images and information, packaging size dimensions, a larger capacity packaging (more product content), ergonomic premium packaging, not easily torn, and impact resistant packaging materials. The findings further confirmed that the design of premium apple pia packaging accepted by the SMES was the one with the capacity of ten apple pia or 200 g weight, and with rectangular or beam shape form. The packaging material used was a duplex carton with 400 grammage (g/m2), the outer part of the packaging was coated with plastic and the inside was added with duplex carton. The acceptable packaging dimension was 30 cm x 5 cm x 3 cm (L x W x H) with a mix of black and yellow color in the graphical design.

Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment.

PubMed

Djuris, Jelena; Djuric, Zorica

2017-11-30

Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbD-based submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented. Copyright © 2017 Elsevier B.V. All rights reserved.

Applying quality by design (QbD) concept for fabrication of chitosan coated nanoliposomes.

PubMed

Pandey, Abhijeet P; Karande, Kiran P; Sonawane, Raju O; Deshmukh, Prashant K

2014-03-01

In the present investigation, a quality by design (QbD) strategy was successfully applied to the fabrication of chitosan-coated nanoliposomes (CH-NLPs) encapsulating a hydrophilic drug. The effects of the processing variables on the particle size, encapsulation efficiency (%EE) and coating efficiency (%CE) of CH-NLPs (prepared using a modified ethanol injection method) were investigated. The concentrations of lipid, cholesterol, drug and chitosan; stirring speed, sonication time; organic:aqueous phase ratio; and temperature were identified as the key factors after risk analysis for conducting a screening design study. A separate study was designed to investigate the robustness of the predicted design space. The particle size, %EE and %CE of the optimized CH-NLPs were 111.3 nm, 33.4% and 35.2%, respectively. The observed responses were in accordance with the predicted response, which confirms the suitability and robustness of the design space for CH-NLP formulation. In conclusion, optimization of the selected key variables will help minimize the problems related to size, %EE and %CE that are generally encountered when scaling up processes for NLP formulations. The robustness of the design space will help minimize both intra-batch and inter-batch variations, which are quite common in the pharmaceutical industry.

Design and realization of high quality prime farmland planning and management information system

NASA Astrophysics Data System (ADS)

Li, Manchun; Liu, Guohong; Liu, Yongxue; Jiang, Zhixin

2007-06-01

The article discusses the design and realization of a high quality prime farmland planning and management information system based on SDSS. Models in concept integration, management planning are used in High Quality Prime Farmland Planning in order to refine the current model system and the management information system is deigned with a triangular structure. Finally an example of Tonglu county high quality prime farmland planning and management information system is introduced.

The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Retrospective Study of Acute Myocardial Infarction: Study Design China PEACE-Retrospective AMI Study Design

PubMed Central

Dharmarajan, Kumar; Li, Jing; Li, Xi; Lin, Zhenqiu; Krumholz, Harlan; Jiang, Lixin

2014-01-01

Background Cardiovascular diseases are rising as a cause of death and disability in China. To improve outcomes for patients with these conditions, the Chinese government, academic researchers, clinicians, and more than 200 hospitals have created China Patient-centered Evaluative Assessment of Cardiac Events (China-PEACE), a national network for research and performance improvement. The first study from China PEACE, the Retrospective Study of Acute Myocardial Infarction (China PEACE-Retrospective AMI Study), is designed to promote improvements in AMI quality of care by generating knowledge about the characteristics, treatments, and outcomes of patients hospitalized with acute myocardial infarction (AMI) across a representative sample of Chinese hospitals over the last decade. Methods and Results The China PEACE-Retrospective AMI Study will examine more than 18,000 patient records from 162 hospitals identified using a 2-stage cluster sampling design within economic-geographic regions. Records were chosen from 2001, 2006, and 2011 to identify temporal trends. Data quality will be monitored by a central coordinating center and will, in particular, address case ascertainment, data abstraction, and data management. Analyses will examine patient characteristics, diagnostic testing patterns, in-hospital treatments, in-hospital outcomes, and variation in results by time and site of care. In addition to publications, data will be shared with participating hospitals and the Chinese government to develop strategies to promote quality improvement. Conclusions The China PEACE-Retrospective AMI Study is the first to leverage the China PEACE platform to better understand AMI across representative sites of care and over the last decade in China. The China PEACE collaboration between government, academicians, clinicians and hospitals is poised to translate research about trends and patterns of AMI practices and outcomes into improved care for patients. PMID:24221838

A Validation of Object-Oriented Design Metrics as Quality Indicators

NASA Technical Reports Server (NTRS)

Basili, Victor R.; Briand, Lionel C.; Melo, Walcelio

1997-01-01

This paper presents the results of a study in which we empirically investigated the suits of object-oriented (00) design metrics introduced in another work. More specifically, our goal is to assess these metrics as predictors of fault-prone classes and, therefore, determine whether they can be used as early quality indicators. This study is complementary to the work described where the same suite of metrics had been used to assess frequencies of maintenance changes to classes. To perform our validation accurately, we collected data on the development of eight medium-sized information management systems based on identical requirements. All eight projects were developed using a sequential life cycle model, a well-known 00 analysis/design method and the C++ programming language. Based on empirical and quantitative analysis, the advantages and drawbacks of these 00 metrics are discussed. Several of Chidamber and Kamerer's 00 metrics appear to be useful to predict class fault-proneness during the early phases of the life-cycle. Also, on our data set, they are better predictors than 'traditional' code metrics, which can only be collected at a later phase of the software development processes.

Design of a randomised intervention study: the effect of dumbbell exercise therapy on physical activity and quality of life among breast cancer survivors in Malaysia

PubMed Central

Rufa'i, Adamu Ahmad; Muda, Wan Abdul Manan Wan; Yen, Siew Hwa; Abd Shatar, Aishah Knight; Murali, Bhavaraju Venkata Krishna; Tan, Shu Wen

2016-01-01

Background Participation in physical activity has a positive impact on the overall health and quality of life, whereas physical inactivity is associated with a poor prognosis among breast cancer survivors. Despite the health-enhancing benefits of physical activity, the majority of Malaysian breast cancer survivors are not physically active. This paper presents the design of a randomised study to evaluate the feasibility and effect of exercise therapy intervention using light resistance dumbbell exercise to promote active lifestyle and improve the quality of life of breast cancer survivors in Malaysia. Methods/design This is an intervention study of a 12-week exercise therapy that will explore and compare the effects of light resistance and aerobic exercise on physical activity level and quality of life components in 102 female breast cancer survivors. Major eligibility criteria include histologically confirmed diagnosis of breast cancer stages I–III, 3–12 months post-diagnosis, and absence of any disorder contraindicating exercise. Participants will be stratified based on menopausal status (pre-menopause vs post-menopause) and then assigned randomly to one of three groups. Participants in group A will participate in a three-times weekly supervised resistance exercise using light resistance dumbbells; participants in group B will participate in a three-times weekly supervised aerobic exercise; while participants in group C (control group) will be given aerobic exercise after completion of the intervention. The primary end points include physical activity level and quality of life components. The secondary end points are body mass index, body composition, total caloric intake, and waist-to-hip ratio. Discussion Although there have been many studies of resistance exercise in breast cancer survivors, this is the first study using this specific mode of resistance. Findings will contribute data on the feasibility and effects of light resistance dumbbell exercises

Tweets about hospital quality: a mixed methods study

PubMed Central

Greaves, Felix; Laverty, Antony A; Cano, Daniel Ramirez; Moilanen, Karo; Pulman, Stephen; Darzi, Ara; Millett, Christopher

2014-01-01

Background Twitter is increasingly being used by patients to comment on their experience of healthcare. This may provide information for understanding the quality of healthcare providers and improving services. Objective To examine whether tweets sent to hospitals in the English National Health Service contain information about quality of care. To compare sentiment on Twitter about hospitals with established survey measures of patient experience and standardised mortality rates. Design A mixed methods study including a quantitative analysis of all 198 499 tweets sent to English hospitals over a year and a qualitative directed content analysis of 1000 random tweets. Twitter sentiment and conventional quality metrics were compared using Spearman's rank correlation coefficient. Key results 11% of tweets to hospitals contained information about care quality, with the most frequent topic being patient experience (8%). Comments on effectiveness or safety of care were present, but less common (3%). 77% of tweets about care quality were positive in tone. Other topics mentioned in tweets included messages of support to patients, fundraising activity, self-promotion and dissemination of health information. No associations were observed between Twitter sentiment and conventional quality metrics. Conclusions Only a small proportion of tweets directed at hospitals discuss quality of care and there was no clear relationship between Twitter sentiment and other measures of quality, potentially limiting Twitter as a medium for quality monitoring. However, tweets did contain information useful to target quality improvement activity. Recent enthusiasm by policy makers to use social media as a quality monitoring and improvement tool needs to be carefully considered and subjected to formal evaluation. PMID:24748372

The project MOHAVE tracer study: study design, data quality, and overview of results

NASA Astrophysics Data System (ADS)

Green, Mark C.

In the winter and summer of 1992, atmospheric tracer studies were conducted in support of project MOHAVE, a visibility study in the southwestern United States. The primary goal of project MOHAVE is to determine the effects of the Mohave power plant and other sources upon visibility at Grand Canyon National Park. Perfluorocarbon tracers (PFTs) were released from the Mohave power plant and other locations and monitored at about 30 sites. The tracer data are being used for source attribution analysis and for evaluation of transport and dispersion models and receptor models. Collocated measurements showed the tracer data to be of high quality and suitable for source attribution analysis and model evaluation. The results showed strong influences of channeling by the Colorado River canyon during both winter and summer. Flow from the Mohave power plant was usually to the south, away from the Grand Canyon in winter and to the northeast, toward the Grand Canyon in summer. Tracer released at Lake Powell in winter was found to often travel downstream through the entire length of the Grand Canyon. Data from summer tracer releases in southern California demonstrated the existence of a convergence zone in the western Mohave Desert.

Analytical procedure validation and the quality by design paradigm.

PubMed

Rozet, Eric; Lebrun, Pierre; Michiels, Jean-François; Sondag, Perceval; Scherder, Tara; Boulanger, Bruno

2015-01-01

Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a quality by design (QbD) approach, there have been many discussions on the opportunity for analytical procedure developments to follow a similar approach. While development and optimization of analytical procedure following QbD principles have been largely discussed and described, the place of analytical procedure validation in this framework has not been clarified. This article aims at showing that analytical procedure validation is fully integrated into the QbD paradigm and is an essential step in developing analytical procedures that are effectively fit for purpose. Adequate statistical methodologies have also their role to play: such as design of experiments, statistical modeling, and probabilistic statements. The outcome of analytical procedure validation is also an analytical procedure design space, and from it, control strategy can be set.

Quality by design in formulation and process development for a freeze-dried, small molecule parenteral product: a case study.

PubMed

Mockus, Linas N; Paul, Timothy W; Pease, Nathan A; Harper, Nancy J; Basu, Prabir K; Oslos, Elizabeth A; Sacha, Gregory A; Kuu, Wei Y; Hardwick, Lisa M; Karty, Jacquelyn J; Pikal, Michael J; Hee, Eun; Khan, Mansoor A; Nail, Steven L

2011-01-01

A case study has been developed to illustrate one way of incorporating a Quality by Design approach into formulation and process development for a small molecule, freeze-dried parenteral product. Sodium ethacrynate was chosen as the model compound. Principal degradation products of sodium ethacrynate result from hydrolysis of the unsaturated ketone in aqueous solution, and dimer formation from a Diels-Alder condensation in the freeze-dried solid state. When the drug crystallizes in a frozen solution, the eutectic melting temperature is above -5°C. Crystallization in the frozen system is affected by pH in the range of pH 6-8 and buffer concentration in the range of 5-50 mM, where higher pH and lower buffer concentration favor crystallization. Physical state of the drug is critical to solid state stability, given the relative instability of amorphous drug. Stability was shown to vary considerably over the ranges of pH and buffer concentration examined, and vial-to-vial variability in degree of crystallinity is a potential concern. The formulation design space was constructed in terms of pH and drug concentration, and assuming a constant 5 mM concentration of buffer. The process design space is constructed to take into account limitations on the process imposed by the product and by equipment capability.

Quality Control through Design and Process: Gambrel Roof Truss Challenge

ERIC Educational Resources Information Center

Ward, Dell; Jones, James

2011-01-01

Customers determine whether a product fulfills their needs or satisfies them. "Quality control", then, is the process of finding out what the customer wants, along with designing, producing, delivering, and servicing the product--and ultimately satisfying the customer's expectations. For many years, people considered a product to be of good…

Quality by Design approach to spray drying processing of crystalline nanosuspensions.

PubMed

Kumar, Sumit; Gokhale, Rajeev; Burgess, Diane J

2014-04-10

Quality by Design (QbD) principles were explored to understand spray drying process for the conversion of liquid nanosuspensions into solid nano-crystalline dry powders using indomethacin as a model drug. The effects of critical process variables: inlet temperature, flow and aspiration rates on critical quality attributes (CQAs): particle size, moisture content, percent yield and crystallinity were investigated employing a full factorial design. A central cubic design was employed to generate the response surface for particle size and percent yield. Multiple linear regression analysis and ANOVA were employed to identify and estimate the effect of critical parameters, establish their relationship with CQAs, create design space and model the spray drying process. Inlet temperature was identified as the only significant factor (p value <0.05) to affect dry powder particle size. Higher inlet temperatures caused drug surface melting and hence aggregation of the dried nano-crystalline powders. Aspiration and flow rates were identified as significant factors affecting yield (p value <0.05). Higher yields were obtained at higher aspiration and lower flow rates. All formulations had less than 3% (w/w) moisture content. Formulations dried at higher inlet temperatures had lower moisture compared to those dried at lower inlet temperatures. Published by Elsevier B.V.

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

2012-01-01

Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities.

PubMed

Orlandini, Serena; Pasquini, Benedetta; Caprini, Claudia; Del Bubba, Massimo; Pinzauti, Sergio; Furlanetto, Sandra

2015-11-01

A fast and selective CE method for the determination of zolmitriptan (ZOL) and its five potential impurities has been developed applying the analytical Quality by Design principles. Voltage, temperature, buffer concentration, and pH were investigated as critical process parameters that can influence the critical quality attributes, represented by critical resolution values between peak pairs, analysis time, and peak efficiency of ZOL-dimer. A symmetric screening matrix was employed for investigating the knowledge space, and a Box-Behnken design was used to evaluate the main, interaction, and quadratic effects of the critical process parameters on the critical quality attributes. Contour plots were drawn highlighting important interactions between buffer concentration and pH, and the gained information was merged into the sweet spot plots. Design space (DS) was established by the combined use of response surface methodology and Monte Carlo simulations, introducing a probability concept and thus allowing the quality of the analytical performances to be assured in a defined domain. The working conditions (with the interval defining the DS) were as follows: BGE, 138 mM (115-150 mM) phosphate buffer pH 2.74 (2.54-2.94); temperature, 25°C (24-25°C); voltage, 30 kV. A control strategy was planned based on method robustness and system suitability criteria. The main advantages of applying the Quality by Design concept consisted of a great increase of knowledge of the analytical system, obtained throughout multivariate techniques, and of the achievement of analytical assurance of quality, derived by probability-based definition of DS. The developed method was finally validated and applied to the analysis of ZOL tablets. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Methodological quality of meta-analyses of single-case experimental studies.

PubMed

Jamshidi, Laleh; Heyvaert, Mieke; Declercq, Lies; Fernández-Castilla, Belén; Ferron, John M; Moeyaert, Mariola; Beretvas, S Natasha; Onghena, Patrick; Van den Noortgate, Wim

2017-12-28

Methodological rigor is a fundamental factor in the validity and credibility of the results of a meta-analysis. Following an increasing interest in single-case experimental design (SCED) meta-analyses, the current study investigates the methodological quality of SCED meta-analyses. We assessed the methodological quality of 178 SCED meta-analyses published between 1985 and 2015 through the modified Revised-Assessment of Multiple Systematic Reviews (R-AMSTAR) checklist. The main finding of the current review is that the methodological quality of the SCED meta-analyses has increased over time, but is still low according to the R-AMSTAR checklist. A remarkable percentage of the studies (93.80% of the included SCED meta-analyses) did not even reach the midpoint score (22, on a scale of 0-44). The mean and median methodological quality scores were 15.57 and 16, respectively. Relatively high scores were observed for "providing the characteristics of the included studies" and "doing comprehensive literature search". The key areas of deficiency were "reporting an assessment of the likelihood of publication bias" and "using the methods appropriately to combine the findings of studies". Although the results of the current review reveal that the methodological quality of the SCED meta-analyses has increased over time, still more efforts are needed to improve their methodological quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

Critical to quality in telemedicine service management: application of DFSS (Design for Six Sigma) and SERVQUAL).

PubMed

Yun, Eun Kyoung; Chun, Kee Moon

2008-01-01

Telemedicine generally refers to the use of communications and information technologies for the delivery of health care. owever, telemedicine is not merely a simple combination of health care and technology. The researchers propose a systematic approach for assessing needs of telemedicine customers, called critical-to-quality (CTQ) in Six Sigma, with a purpose of continuous quality improvement. The combination approach using DFSS (Design for Six Sigma) and SERVQUAL (Service Quality Framework) was applied to define the critical quality attributes of telemedicine service management and to match them with the current telemedicine process. With a step-by-step procedure, telemedicine service process was reviewed and all the important CTQ candidates identified via a case study. The findings suggest that nurses need further understanding and research methods that will improve and manage the quality of health care service in various medical fields.

Designing relevant biochars to revitalize soil quality: Current status and advances

EPA Science Inventory

Biochars chemical and physical properties can be designed to improve specific soil quality issues. In order to make appropriate selections, evaluations are required of different feedstocks, pyrolysis conditions, and gross biochar particle sizes. We conducted laboratory soil incu...

Inertial Motion Capture Costume Design Study

PubMed Central

Szczęsna, Agnieszka; Skurowski, Przemysław; Lach, Ewa; Pruszowski, Przemysław; Pęszor, Damian; Paszkuta, Marcin; Słupik, Janusz; Lebek, Kamil; Janiak, Mateusz; Polański, Andrzej; Wojciechowski, Konrad

2017-01-01

The paper describes a scalable, wearable multi-sensor system for motion capture based on inertial measurement units (IMUs). Such a unit is composed of accelerometer, gyroscope and magnetometer. The final quality of an obtained motion arises from all the individual parts of the described system. The proposed system is a sequence of the following stages: sensor data acquisition, sensor orientation estimation, system calibration, pose estimation and data visualisation. The construction of the system’s architecture with the dataflow programming paradigm makes it easy to add, remove and replace the data processing steps. The modular architecture of the system allows an effortless introduction of a new sensor orientation estimation algorithms. The original contribution of the paper is the design study of the individual components used in the motion capture system. The two key steps of the system design are explored in this paper: the evaluation of sensors and algorithms for the orientation estimation. The three chosen algorithms have been implemented and investigated as part of the experiment. Due to the fact that the selection of the sensor has a significant impact on the final result, the sensor evaluation process is also explained and tested. The experimental results confirmed that the choice of sensor and orientation estimation algorithm affect the quality of the final results. PMID:28304337

[Application of quality by design in granulation process for Ginkgo leaf tablet (Ⅲ)： process control strategy based on design space].

PubMed

Cui, Xiang-Long; Xu, Bing; Sun, Fei; Dai, Sheng-Yun; Shi, Xin-Yuan; Qiao, Yan-Jiang

2017-03-01

In this paper, under the guidance of quality by design (QbD) concept, the control strategy of the high shear wet granulation process of the ginkgo leaf tablet based on the design space was established to improve the process controllability and product quality consistency. The median granule size (D50) and bulk density (Da) of granules were identified as critical quality attributes (CQAs) and potential critical process parameters (pCPPs) were determined by the failure modes and effect analysis (FMEA). The Plackeet-Burmann experimental design was used to screen pCPPs and the results demonstrated that the binder amount, the wet massing time and the wet mixing impeller speed were critical process parameters (CPPs). The design space of the high shear wet granulation process was developed within pCPPs range based on the Box-Behnken design and quadratic polynomial regression models. ANOVA analysis showed that the P-values of model were less than 0.05 and the values of lack of fit test were more than 0.1, indicating that the relationship between CQAs and CPPs could be well described by the mathematical models. D₅₀ could be controlled within 170 to 500 μm, and the bulk density could be controlled within 0.30 to 0.44 g•cm⁻³ by using any CPPs combination within the scope of design space. Besides, granules produced by process parameters within the design space region could also meet the requirement of tensile strength of the ginkgo leaf tablet.. Copyright© by the Chinese Pharmaceutical Association.

A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol.

PubMed

Robert, Glenn B; Anderson, Janet E; Burnett, Susan J; Aase, Karina; Andersson-Gare, Boel; Bal, Roland; Calltorp, Johan; Nunes, Francisco; Weggelaar, Anne-Marie; Vincent, Charles A; Fulop, Naomi J

2011-10-26

although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in Europe by Research' (QUASER) study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how these impact on the quality of health care; the findings will be designed to help policy makers, payers and hospital managers understand the factors and processes that enable hospitals in Europe to achieve-and sustain-high quality services for their patients. in-depth multi-level (macro, meso and micro-system) analysis of healthcare quality policies and practices in 5 European countries, including longitudinal case studies in a purposive sample of 10 hospitals. The project design has three major features: • a working definition of quality comprising three components: clinical effectiveness, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes) and quantitative research (secondary analysis of safety and quality data, for example: adverse incident reporting; patient complaints and claims). the protocol is based on the premise that future research, policy and practice need to address the

Does a quality management system improve quality in primary care practices in Switzerland? A longitudinal study

PubMed Central

Goetz, Katja; Hess, Sigrid; Jossen, Marianne; Huber, Felix; Rosemann, Thomas; Brodowski, Marc; Künzi, Beat; Szecsenyi, Joachim

2015-01-01

Objectives To examine the effectiveness of the quality management programme—European Practice Assessment—in primary care in Switzerland. Design Longitudinal study with three points of measurement. Setting Primary care practices in Switzerland. Participants In total, 45 of 91 primary care practices completed European Practice Assessment three times. Outcomes The interval between each assessment was around 36 months. A variance analyses for repeated measurements were performed for all 129 quality indicators from the domains: ‘infrastructure’, ‘information’, ‘finance’, and ‘quality and safety’ to examine changes over time. Results Significant improvements were found in three of four domains: ‘quality and safety’ (F=22.81, p<0.01), ‘information’ (F=27.901, p<0.01) and ‘finance’ (F=4.073, p<0.02). The 129 quality indicators showed a significant improvement within the three points of measurement (F=33.864, p<0.01). Conclusions The European Practice Assessment for primary care practices thus provides a functioning quality management programme, focusing on the sustainable improvement of structural and organisational aspects to promote high quality of primary care. The implementation of a quality management system which also includes a continuous improvement process would give added value to provide good care. PMID:25900466

Quality of reporting of descriptive studies in implant dentistry. Critical aspects in design, outcome assessment and clinical relevance.

PubMed

Meijer, Henny J A; Raghoebar, Gerry M

2012-02-01

The aim of this study was to conduct a review on quality of reporting on descriptive studies in implant dentistry using the STROBE Statement and to analyse possible changes in quality of reporting on descriptive studies in implant dentistry over time. A hand search to select descriptive studies was carried out in seven dental journals, which were thought to have interest in the field of dental implants. Issues of the years 1990, 1995, 2000, 2005 and 2010 were screened. The STROBE Statement with 22 criteria to match was used to determine the quality of an article. Totally 4657 titles and abstracts were screened; 260 of them were found to be reporting on a descriptive study. Percentages of properly addressed items were 46% in 1990, 56% in 1995, 54% in 2000, 59% in 2005 and 70% in 2010. From this review can be concluded that quality of reporting on descriptive studies in implant dentistry is low; there is some improvement from 1990 to 2010, but it does not exceed 70% coverage of the possible to address items. © 2012 John Wiley & Sons A/S.

Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus.

PubMed

Nobels, Frank; Debacker, Noëmi; Brotons, Carlos; Elisaf, Moses; Hermans, Michel P; Michel, Georges; Muls, Erik

2011-09-22

To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Recruitment was completed in December 2008 with 3994 evaluable patients. This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. NCT00681850.

Designing climate-resilient rice with ideal grain quality suited for high-temperature stress

PubMed Central

Sreenivasulu, Nese; Butardo, Vito M.; Misra, Gopal; Cuevas, Rosa Paula; Anacleto, Roslen; Kavi Kishor, Polavarpu B.

2015-01-01

To ensure rice food security, the target outputs of future rice breeding programmes should focus on developing climate-resilient rice varieties with emphasis on increased head rice yield coupled with superior grain quality. This challenge is made greater by a world that is increasingly becoming warmer. Such environmental changes dramatically impact head rice and milling yield as well as increasing chalkiness because of impairment in starch accumulation and other storage biosynthetic pathways in the grain. This review highlights the knowledge gained through gene discovery via quantitative trait locus (QTL) cloning and structural–functional genomic strategies to reduce chalk, increase head rice yield, and develop stable lines with optimum grain quality in challenging environments. The newly discovered genes and the knowledge gained on the influence of specific alleles related to stability of grain quality attributes provide a robust platform for marker-assisted selection in breeding to design heat-tolerant rice varieties with superior grain quality. Using the chalkiness trait in rice as a case study, we demonstrate here that the emerging field of systems genetics can help fast-track the identification of novel alleles and gene targets that can be pyramided for the development of environmentally robust rice varieties that possess improved grain quality. PMID:25662847

An intelligent case-adjustment algorithm for the automated design of population-based quality auditing protocols.

PubMed

Advani, Aneel; Jones, Neil; Shahar, Yuval; Goldstein, Mary K; Musen, Mark A

2004-01-01

We develop a method and algorithm for deciding the optimal approach to creating quality-auditing protocols for guideline-based clinical performance measures. An important element of the audit protocol design problem is deciding which guide-line elements to audit. Specifically, the problem is how and when to aggregate individual patient case-specific guideline elements into population-based quality measures. The key statistical issue involved is the trade-off between increased reliability with more general population-based quality measures versus increased validity from individually case-adjusted but more restricted measures done at a greater audit cost. Our intelligent algorithm for auditing protocol design is based on hierarchically modeling incrementally case-adjusted quality constraints. We select quality constraints to measure using an optimization criterion based on statistical generalizability coefficients. We present results of the approach from a deployed decision support system for a hypertension guideline.

Design of Cycle 3 of the National Water-Quality Assessment Program, 2013-23: Part 2: Science plan for improved water-quality information and management

USGS Publications Warehouse

Rowe, Gary L.; Belitz, Kenneth; Demas, Charlie R.; Essaid, Hedeff I.; Gilliom, Robert J.; Hamilton, Pixie A.; Hoos, Anne B.; Lee, Casey J.; Munn, Mark D.; Wolock, David W.

2013-01-01

This report presents a science strategy for the third decade of the National Water-Quality Assessment (NAWQA) Program, which since 1991, has been responsible for providing nationally consistent information on the quality of the Nation's streams and groundwater; how water quality is changing over time; and the major natural and human factors that affect current water quality conditions and trends. The strategy is based on an extensive evaluation of the accomplishments of NAWQA over its first two decades, the current status of water-quality monitoring activities by USGS and its partners, and an updated analysis of stakeholder priorities. The plan is designed to address priority issues and national needs identified by NAWQA stakeholders and the National Research Council (2012) irrespective of budget constraints. This plan describes four major goals for the third decade (Cycle 3), the approaches for monitoring, modeling, and scientific studies, key partnerships required to achieve these goals, and products and outcomes that will result from planned assessment activities. The science plan for 2013–2023 is a comprehensive approach to meet stakeholder priorities for: (1) rebuilding NAWQA monitoring networks for streams, rivers, and groundwater, and (2) upgrading models used to extrapolate and forecast changes in water-quality and stream ecosystem condition in response to changing climate and land use. The Cycle 3 plan continues approaches that have been central to the Program’s long-term success, but adjusts monitoring intensities and study designs to address critical information needs and identified data gaps. Restoration of diminished monitoring networks and new directions in modeling and interpretative studies address growing and evolving public and stakeholder needs for water-quality information and improved management, particularly in the face of increasing challenges related to population growth, increasing demands for water, and changing land use and climate

Water quality study of Sunter River in Jakarta, Indonesia

NASA Astrophysics Data System (ADS)

Martinus, Y.; Astono, W.; Hendrawan, D.

2018-01-01

Sunter River flows in the city of Jakarta with the designation of river water for agricultural purposes, and can be utilized for urban business and hydroelectric power industry. This study aims to determine the Sunter River water quality based on physical and chemical parameters. Water sampling was conducted 2 times which done in April and May with 5 sampling stations for measuring. The samples was analayzed in the laboratory according SNI methods for parameters BOD, COD, PO4 3-, NO3, Oil & Grease and Detergents. The quality status of Sunter River is determined by the Pollutant Index method. The results show that the water quality of Sunter River is influenced by organic parameter as dominant pollutant with COD concentration ranging from 48 mg/l - 182.4 mg/l and BOD concentration ranging from 14.69 mg/L - 98.91 mg/L. The Pollution Index calculation results show that the water quality status of Sunter River is moderate polluted with IP 6.47. The source of pollutants generally comes from the urban drainage channels, tributaries, and slaughtering industry. The results of this study expected to be use by the government to improve the water quality of Sunter River for better environment.

Universal Design as a Booster for Housing Quality and Architectural Practice.

PubMed

Denizou, Karine

2016-01-01

Norwegian central government has for the last decade increasingly focused on universal design. Fundamental changes in the Norwegian building code and corresponding regulations in 2010 give an apparently clear framework for the implementation of accessibility and universal design. However, it seems that neither increased awareness of accessibility requirements and universal design, nor compliance with the building code guarantees improvement of housing quality and usability. The Norwegian regulations have gone further in the direction of performance requirements than most other countries. This applies to all types of requirements, including requirements for usability, functionality and accessibility. Hardly any specifications are to be found in the regulations. Ideally, this lack of specifications should give designers the opportunity to develop innovative answers and hence to respond to different contexts and needs. Still, many architects and builders ask for clear specifications, in order to simplify and speed up design processes and make control of solutions easier. Many architects understand guidelines as minimum requirements, and are thus reproducing the identical solutions without considering the context and the needs of the users. They see accessibility as another regulatory pressure and requirements as restrictions rather than positive incentives. However, there are examples of designers who have internalised the regulatory framework and thus are able to create and integrate inclusive design in their daily work. Based on recent research conducted by SINTEF Building and Infrastructure and financed by the Norwegian State Housing Bank, this paper presents examples of practice where dwellings have been developed within a framework of universal design. Focus of the research has been on the approach of the design team and their understanding and use of the regulatory framework in order to create better homes in dialogue with the building authorities. Main

Evaluation of water-quality characteristics and sampling design for streams in North Dakota, 1970–2008

USGS Publications Warehouse

Galloway, Joel M.; Vecchia, Aldo V.; Vining, Kevin C.; Densmore, Brenda K.; Lundgren, Robert F.

2012-01-01

In response to the need to examine the large amount of historic water-quality data comprehensively across North Dakota and evaluate the efficiency of the State-wide sampling programs, a study was done by the U.S. Geological Survey in cooperation with the North Dakota State Water Commission and the North Dakota Department of Health to describe the water-quality data collected for the various programs and determine an efficient State-wide sampling design for monitoring future water-quality conditions. Although data collected for the North Dakota State Water Commission High-Low Sampling Program, the North Dakota Department of Health Ambient Water-Quality Network, and other projects and programs provide valuable information on the quality of water in streams in North Dakota, the objectives vary among the programs, some of the programs overlap spatially and temporally, and the various sampling designs may not be the most efficient or relevant to the objectives of the individual programs as they have changed through time. One objective of a State-wide sampling program was to evaluate ways to describe the spatial variability of water-quality conditions across the State in the most efficient manner. Weighted least-squares regression analysis was used to relate the average absolute difference between paired downstream and upstream concentrations, expressed as a percent of the average downstream concentration, to the average absolute difference in daily flow between the downstream and upstream pairs, expressed as a percent of the average downstream flow. The analysis showed that a reasonable spatial network would consist of including the most downstream sites in large basins first, followed by the next upstream site(s) that roughly bisect the downstream flows at the first sites, followed by the next upstream site(s) that roughly bisect flows for the second sites. Sampling sites to be included in a potential State-wide network were prioritized into 3 design levels: level 1

A Water Quality Study in Rutherford County, Tennessee: Student Group Project

ERIC Educational Resources Information Center

James, Rebecca R.; Ogden, Albert E.; DiVincenzo, John P.

2006-01-01

Undergraduate research is the most rewarding way for science students to become exposed to the process of scientific investigation. Water quality studies offer the unique advantages of being easily designed by the students and analytically approachable. This two-part, 14-month study involved several students in the delineation of ground water flow…

Systematic review of the quality of prognosis studies in systemic lupus erythematosus.

PubMed

Lim, Lily S H; Lee, Senq J; Feldman, Brian M; Gladman, Dafna D; Pullenayegum, Eleanor; Uleryk, Elizabeth; Silverman, Earl D

2014-10-01

Prognosis studies examine outcomes and/or seek to identify predictors or factors associated with outcomes. Many prognostic factors have been identified in systemic lupus erythematosus (SLE), but few have been consistently found across studies. We hypothesized that this is due to a lack of rigor of study designs. This study aimed to systematically assess the methodologic quality of prognosis studies in SLE. A search of prognosis studies in SLE was performed using MEDLINE and Embase, from January 1990 to June 2011. A representative sample of 150 articles was selected using a random number generator and assessed by 2 reviewers. Each study was assessed by a risk of bias tool according to 6 domains: study participation, study attrition, measurement of prognostic factors, measurement of outcomes, measurement/adjustment for confounders, and appropriateness of statistical analysis. Information about missing data was also collected. A cohort design was used in 71% of studies. High risk of bias was found in 65% of studies for confounders, 57% for study participation, 56% for attrition, 36% for statistical analyses, 20% for prognostic factors, and 18% for outcome. Missing covariate or outcome information was present in half of the studies. Only 6 studies discussed reasons for missing data and 2 imputed missing data. Lack of rigorous study design, especially in addressing confounding, study participation and attrition, and inadequately handled missing data, has limited the quality of prognosis studies in SLE. Future prognosis studies should be designed with consideration of these factors to improve methodologic rigor. Copyright © 2014 by the American College of Rheumatology.

Deepening our understanding of quality improvement in Europe (DUQuE): overview of a study of hospital quality management in seven countries

PubMed Central

Secanell, Mariona; Groene, Oliver; Arah, Onyebuchi A.; Lopez, Maria Andrée; Kutryba, Basia; Pfaff, Holger; Klazinga, Niek; Wagner, Cordula; Kristensen, Solvejg; Bartels, Paul Daniel; Garel, Pascal; Bruneau, Charles; Escoval, Ana; França, Margarida; Mora, Nuria; Suñol, Rosa; Klazinga, N; Kringos, DS; Lopez, MA; Secanell, M; Sunol, R; Vallejo, P; Bartels, P; Kristensen, S; Michel, P; Saillour-Glenisson, F; Vlcek, F; Car, M; Jones, S; Klaus, E; Bottaro, S; Garel, P; Saluvan, M; Bruneau, C; Depaigne-Loth, A; Shaw, C; Hammer, A; Ommen, O; Pfaff, H; Groene, O; Botje, D; Wagner, C; Kutaj-Wasikowska, H; Kutryba, B; Escoval, A; Lívio, A; Eiras, M; Franca, M; Leite, I; Almeman, F; Kus, H; Ozturk, K; Mannion, R; Arah, OA; Chow, A; DerSarkissian, M; Thompson, CA; Wang, A; Thompson, A

2014-01-01

Introduction and Objective This paper provides an overview of the DUQuE (Deepening our Understanding of Quality Improvement in Europe) project, the first study across multiple countries of the European Union (EU) to assess relationships between quality management and patient outcomes at EU level. The paper describes the conceptual framework and methods applied, highlighting the novel features of this study. Design DUQuE was designed as a multi-level cross-sectional study with data collection at hospital, pathway, professional and patient level in eight countries. Setting and Participants We aimed to collect data for the assessment of hospital-wide constructs from up to 30 randomly selected hospitals in each country, and additional data at pathway and patient level in 12 of these 30. Main outcome measures A comprehensive conceptual framework was developed to account for the multiple levels that influence hospital performance and patient outcomes. We assessed hospital-specific constructs (organizational culture and professional involvement), clinical pathway constructs (the organization of care processes for acute myocardial infarction, stroke, hip fracture and deliveries), patient-specific processes and outcomes (clinical effectiveness, patient safety and patient experience) and external constructs that could modify hospital quality (external assessment and perceived external pressure). Results Data was gathered from 188 hospitals in 7 participating countries. The overall participation and response rate were between 75% and 100% for the assessed measures. Conclusions This is the first study assessing relation between quality management and patient outcomes at EU level. The study involved a large number of respondents and achieved high response rates. This work will serve to develop guidance in how to assess quality management and makes recommendations on the best ways to improve quality in healthcare for hospital stakeholders, payers, researchers, and policy makers

Evaluating radiographers' diagnostic accuracy in screen-reading mammograms: what constitutes a quality study?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Debono, Josephine C, E-mail: josephine.debono@bci.org.au; Poulos, Ann E; Westmead Breast Cancer Institute, Westmead, New South Wales

The aim of this study was to first evaluate the quality of studies investigating the diagnostic accuracy of radiographers as mammogram screen-readers and then to develop an adapted tool for determining the quality of screen-reading studies. A literature search was used to identify relevant studies and a quality evaluation tool constructed by combining the criteria for quality of Whiting, Rutjes, Dinnes et al. and Brealey and Westwood. This constructed tool was then applied to the studies and subsequently adapted specifically for use in evaluating quality in studies investigating diagnostic accuracy of screen-readers. Eleven studies were identified and the constructed toolmore » applied to evaluate quality. This evaluation resulted in the identification of quality issues with the studies such as potential for bias, applicability of results, study conduct, reporting of the study and observer characteristics. An assessment of the applicability and relevance of the tool for this area of research resulted in adaptations to the criteria and the development of a tool specifically for evaluating diagnostic accuracy in screen-reading. This tool, with further refinement and rigorous validation can make a significant contribution to promoting well-designed studies in this important area of research and practice.« less

What Is the Methodologic Quality of Human Therapy Studies in ISI Surgical Publications?

PubMed Central

Manterola, Carlos; Pineda, Viviana; Vial, Manuel; Losada, Héctor

2006-01-01

Objective: To determine the methodologic quality of therapy articles about humans published in ISI surgical journals, and to explore the association between methodologic quality, origin, and subject matter. Summary Background Data: It is supposed that ISI journals contain the best methodologic articles. Methods: This is a bibliometric study. All journals listed in the 2002 ISI under the subject heading of “Surgery” were included. A simple randomized sampling was conducted for selected journals (Annals of Surgery, The American Surgeon, Archives of Surgery, British Journal of Surgery, European Journal of Surgery, Journal of the American College of Surgeons, Surgery, and World Journal of Surgery). Published articles related to therapy on humans of the selected journals were reviewed and analyzed. All kinds of clinical designs were considered, excluding editorials, review articles, letters to the editor, and experimental studies. The variables considered were: place of origin, design, and the methodologic quality of articles, which was determined by applying a valid and reliable scale. The review was performed interchangeably and independently by 2 research teams. Descriptive and analytical statistics were used. Statistical significance was defined as P values less than 1%. Results: A total of 653 articles were studied. Studies came predominantly from the United States and Europe (43.6% and 36.8%, respectively). The subject areas most frequently found were digestive and hepatobiliopancreatic surgery (29.1% and 24.5%, respectively). Average and median methodologic quality scores of the entire series were 11.6 ± 4.9 points and 11 points, respectively. The association between methodologic quality and journals was determined. Also, the association between methodologic quality and origin was observed, but no association with subject area was verified. Conclusions: The methodologic quality of therapy articles published in the journals analyzed is low; however

Statistical issues in quality control of proteomic analyses: good experimental design and planning.

PubMed

Cairns, David A

2011-03-01

Quality control is becoming increasingly important in proteomic investigations as experiments become more multivariate and quantitative. Quality control applies to all stages of an investigation and statistics can play a key role. In this review, the role of statistical ideas in the design and planning of an investigation is described. This involves the design of unbiased experiments using key concepts from statistical experimental design, the understanding of the biological and analytical variation in a system using variance components analysis and the determination of a required sample size to perform a statistically powerful investigation. These concepts are described through simple examples and an example data set from a 2-D DIGE pilot experiment. Each of these concepts can prove useful in producing better and more reproducible data. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Evaluation models and criteria of the quality of hospital websites: a systematic review study

PubMed Central

Jeddi, Fatemeh Rangraz; Gilasi, Hamidreza; Khademi, Sahar

2017-01-01

Introduction Hospital websites are important tools in establishing communication and exchanging information between patients and staff, and thus should enjoy an acceptable level of quality. The aim of this study was to identify proper models and criteria to evaluate the quality of hospital websites. Methods This research was a systematic review study. The international databases such as Science Direct, Google Scholar, PubMed, Proquest, Ovid, Elsevier, Springer, and EBSCO together with regional database such as Magiran, Scientific Information Database, Persian Journal Citation Report (PJCR) and IranMedex were searched. Suitable keywords including website, evaluation, and quality of website were used. Full text papers related to the research were included. The criteria and sub criteria of the evaluation of website quality were extracted and classified. Results To evaluate the quality of the websites, various models and criteria were presented. The WEB-Q-IM, Mile, Minerva, Seruni Luci, and Web-Qual models were the designed models. The criteria of accessibility, content and apparent features of the websites, the design procedure, the graphics applied in the website, and the page’s attractions have been mentioned in the majority of studies. Conclusion The criteria of accessibility, content, design method, security, and confidentiality of personal information are the essential criteria in the evaluation of all websites. It is suggested that the ease of use, graphics, attractiveness and other apparent properties of websites are considered as the user-friendliness sub criteria. Further, the criteria of speed and accessibility of the website should be considered as sub criterion of efficiency. When determining the evaluation criteria of the quality of websites, attention to major differences in the specific features of any website is essential. PMID:28465807

Evaluation models and criteria of the quality of hospital websites: a systematic review study.

PubMed

Jeddi, Fatemeh Rangraz; Gilasi, Hamidreza; Khademi, Sahar

2017-02-01

Hospital websites are important tools in establishing communication and exchanging information between patients and staff, and thus should enjoy an acceptable level of quality. The aim of this study was to identify proper models and criteria to evaluate the quality of hospital websites. This research was a systematic review study. The international databases such as Science Direct, Google Scholar, PubMed, Proquest, Ovid, Elsevier, Springer, and EBSCO together with regional database such as Magiran, Scientific Information Database, Persian Journal Citation Report (PJCR) and IranMedex were searched. Suitable keywords including website, evaluation, and quality of website were used. Full text papers related to the research were included. The criteria and sub criteria of the evaluation of website quality were extracted and classified. To evaluate the quality of the websites, various models and criteria were presented. The WEB-Q-IM, Mile, Minerva, Seruni Luci, and Web-Qual models were the designed models. The criteria of accessibility, content and apparent features of the websites, the design procedure, the graphics applied in the website, and the page's attractions have been mentioned in the majority of studies. The criteria of accessibility, content, design method, security, and confidentiality of personal information are the essential criteria in the evaluation of all websites. It is suggested that the ease of use, graphics, attractiveness and other apparent properties of websites are considered as the user-friendliness sub criteria. Further, the criteria of speed and accessibility of the website should be considered as sub criterion of efficiency. When determining the evaluation criteria of the quality of websites, attention to major differences in the specific features of any website is essential.

Quality by design approach for understanding the critical quality attributes of cyclosporine ophthalmic emulsion.

PubMed

Rahman, Ziyaur; Xu, Xiaoming; Katragadda, Usha; Krishnaiah, Yellela S R; Yu, Lawrence; Khan, Mansoor A

2014-03-03

Restasis is an ophthalmic cyclosporine emulsion used for the treatment of dry eye syndrome. There are no generic products for this product, probably because of the limitations on establishing in vivo bioequivalence methods and lack of alternative in vitro bioequivalence testing methods. The present investigation was carried out to understand and identify the appropriate in vitro methods that can discriminate the effect of formulation and process variables on critical quality attributes (CQA) of cyclosporine microemulsion formulations having the same qualitative (Q1) and quantitative (Q2) composition as that of Restasis. Quality by design (QbD) approach was used to understand the effect of formulation and process variables on critical quality attributes (CQA) of cyclosporine microemulsion. The formulation variables chosen were mixing order method, phase volume ratio, and pH adjustment method, while the process variables were temperature of primary and raw emulsion formation, microfluidizer pressure, and number of pressure cycles. The responses selected were particle size, turbidity, zeta potential, viscosity, osmolality, surface tension, contact angle, pH, and drug diffusion. The selected independent variables showed statistically significant (p < 0.05) effect on droplet size, zeta potential, viscosity, turbidity, and osmolality. However, the surface tension, contact angle, pH, and drug diffusion were not significantly affected by independent variables. In summary, in vitro methods can detect formulation and manufacturing changes and would thus be important for quality control or sameness of cyclosporine ophthalmic products.

The Design of Mechatronics Simulator for Improving the Quality of Student Learning Course in Mechatronics

NASA Astrophysics Data System (ADS)

Kustija, J.; Hasbullah; Somantri, Y.

2018-02-01

Learning course on mechatronics specifically the Department of Electrical Engineering Education FPTK UPI still using simulation-aided instructional materials and software. It is still not maximizing students’ competencies in mechatronics courses required to skilfully manipulate the real will are implemented both in industry and in educational institutions. The purpose of this study is to submit a design of mechatronic simulator to improve student learning outcomes at the course mechatronics viewed aspects of cognitive and psychomotor. Learning innovation products resulting from this study is expected to be a reference and a key pillar for all academic units at UPI in implementing the learning environment. The method used in this research is quantitative method with the approach of Research and Development (R and D). Steps being taken in this study includes a preliminary study, design and testing of the design of mechatronic simulator that will be used in the course of mechatronics in DPTE FPTK UPI. Results of mechatronic design simulator which has been in testing using simulation modules and is expected to motivate students to improve the quality of learning good study results in the course of mechatronic expected to be realized.

Hypothesis driven drug design: improving quality and effectiveness of the design-make-test-analyse cycle.

PubMed

Plowright, Alleyn T; Johnstone, Craig; Kihlberg, Jan; Pettersson, Jonas; Robb, Graeme; Thompson, Richard A

2012-01-01

In drug discovery, the central process of constructing and testing hypotheses, carefully conducting experiments and analysing the associated data for new findings and information is known as the design-make-test-analyse cycle. Each step relies heavily on the inputs and outputs of the other three components. In this article we report our efforts to improve and integrate all parts to enable smooth and rapid flow of high quality ideas. Key improvements include enhancing multi-disciplinary input into 'Design', increasing the use of knowledge and reducing cycle times in 'Make', providing parallel sets of relevant data within ten working days in 'Test' and maximising the learning in 'Analyse'. Copyright © 2011 Elsevier Ltd. All rights reserved.

A study on the sleep quality of incoming university students.

PubMed

Cheng, Shu Hui; Shih, Chi-Chen; Lee, I Hui; Hou, Yi-Wen; Chen, Kao Chin; Chen, Kow-Tong; Yang, Yen Kuang; Yang, Yi Ching

2012-05-30

This study was designed to examine the prevalence and the risk factors of poor sleep quality in 4318 incoming university students in Taiwan. The test battery comprised a self-administered structured questionnaire, including items related to personal medical history and lifestyle habits, the Measurement of Support Functions (MSF), Pittsburgh Sleep Quality Index (PSQI), Chinese Internet Addiction Scale-Revision (CIAS-R), neuroticism subscale of the Maudsley Personality Inventory (MPI), and the 12-item Chinese Health Questionnaire (CHQ-12). Of the total study population, 2360 students (54.7%) were classified into the poor sleep quality group, as defined by a PSQI score ≥6. Based on the results of multivariate logistic regression analysis, poor sleep quality was significantly associated with undergraduate students, female gender, skipping breakfast, tea drinking, a higher tendency toward internet addition, poor social support, higher neuroticism, and higher CHQ scores. Poor sleep quality is prevalent among incoming university students in Taiwan, and more work is needed on the identification of the factors influencing poor sleep, and in providing systematic education in the importance of sleep and time management skills to university students. Copyright © 2012 Elsevier Ltd. All rights reserved.

The effects of aircraft design on STOL ride quality

NASA Technical Reports Server (NTRS)

Jones, C. R.; Jacobson, I. D.

1975-01-01

Effects of aircraft dynamic characteristics on passenger ride quality are investigated to determine ride-quality isocontours similar to aircraft handling-qualities contours. Measurements are made on a moving-base simulator while varying the aircraft short-period and Dutch Roll frequencies and dampings. Both pilot ratings and subjective ride-quality ratings are obtained during flight. Ride and handling qualities were found to be complementary for the Dutch Roll mode, but not for the short-period mode. Regions of optimal ride and handling qualities are defined for the short-period mode, and the effects of turbulence levels studied.

Improving quality and safety in nursing homes and home care: the study protocol of a mixed-methods research design to implement a leadership intervention

PubMed Central

Wiig, Siri; Ree, Eline; Johannessen, Terese; Strømme, Torunn; Storm, Marianne; Aase, Ingunn; Ullebust, Berit; Holen-Rabbersvik, Elisabeth; Hurup Thomsen, Line; Sandvik Pedersen, Anne Torhild; van de Bovenkamp, Hester; Bal, Roland; Aase, Karina

2018-01-01

Introduction Nursing homes and home care face challenges across different countries as people are living longer, often with chronic conditions. There is a lack of knowledge regarding implementation and impact of quality and safety interventions as most research evidence so far is generated in hospitals. Additionally, there is a lack of effective leadership tools for quality and safety improvement work in this context. Methods and analysis The aim of the ‘Improving Quality and Safety in Primary Care—Implementing a Leadership Intervention in Nursing Homes and Homecare’ (SAFE-LEAD) study is to develop and evaluate a research-based leadership guide for managers to increase quality and safety competence. The project applies a mixed-methods design and explores the implications of the leadership guide on managers’ and staffs’ knowledge, attitudes and practices. Four nursing homes and four home care services from different Norwegian municipalities will participate in the intervention. Surveys, process evaluation (interviews, observations) and document analyses will be conducted to evaluate the implementation and impact of the leadership intervention. A comparative study of Norway and the Netherlands will establish knowledge of the context dependency of the intervention. Ethics and dissemination The study is approved by the Norwegian Centre for Research Data (2017/52324 and 54855). The results will be disseminated through scientific articles, two PhD dissertations, an anthology, presentations at national and international conferences, and in social media, newsletters and in the press. The results will generate knowledge to inform leadership practices in nursing homes and home care. Moreover, the study will build new theory on leadership interventions and the role of contextual factors in nursing homes and home care. PMID:29599394

The Uses of Time for Teaching and Learning. Volume III: Research Design and Method. Studies of Education Reform.

ERIC Educational Resources Information Center

Policy Studies Associates, Inc., Washington, DC.

This report describes the research design of a study that identified and evaluated a collection of reforms designed to enhance learning by altering the amount of and/or the quality of time devoted to learning. The study focused on the quantity and quality of time that teachers and students spent in school and, to a lesser extent, students'…

Variables associated with sleep quality in chronic tension-type headache: A cross-sectional and longitudinal design.

PubMed

Benito-González, Elena; Palacios-Ceña, Maria; Fernández-Muñoz, Juan J; Castaldo, Matteo; Wang, Kelun; Catena, Antonella; Arendt-Nielsen, Lars; Fernández-de-Las-Peñas, César

2018-01-01

To investigate variables associated at baseline (cross-sectional design) and at one year (longitudinal design) with the quality of sleep in chronic tension-type headache (CTTH). One hundred and eighty (n = 180) and 135 individuals with CTTH participated in the cross-sectional and longitudinal design respectively. Clinical features were collected with a 4-weeks headache diary at baseline and one-year follow-up. Sleep quality was assessed at baseline and 1-year follow-up with the Pittsburgh Sleep Quality Index. Anxiety and depression (Hospital Anxiety and Depression Scale-HADS), burden of headache (Headache Disability Inventory-HDI), quality of life (SF-36 questionnaire), and pressure pain thresholds (PPTs) at trigeminal, extra-trigeminal and widespread area were assessed at baseline. Hierarchical regression analyses were conducted to determine the associations between variables at baseline and 1-year follow-up with sleep quality. At baseline positive correlations between sleep quality and headache intensity, headache frequency, headache duration, emotional and physical burden of headache and depression were observed. The regression analyses found that depression and emotional burden of headache explained 27.5% of the variance in sleep quality at baseline (r2 = .262; F = 23.72 P < .001). At one-year, sleep quality was significantly associated with baseline burden of headache, depression, widespread PPTs, vitality and mental health domains. Regression analyses revealed that vitality, PPT over the second metacarpal and PPT over the neck explained 30.0% of the variance of sleep quality at one-year (r2 = .269, F = 9.71, P < .001). It seems that sleep quality exhibits a complex interaction in individuals with CTTH since depression and the emotional burden were associated with sleep quality at baseline, but vitality and PPTs over extra-trigeminal areas were associated with the quality of sleep at one-year.

Design and Implementation of the Harvard Fellowship in Patient Safety and Quality.

PubMed

Gandhi, Tejal K; Abookire, Susan A; Kachalia, Allen; Sands, Kenneth; Mort, Elizabeth; Bommarito, Grace; Gagne, Jane; Sato, Luke; Weingart, Saul N

2016-01-01

The Harvard Fellowship in Patient Safety and Quality is a 2-year physician-oriented training program with a strong operational orientation, embedding trainees in the quality departments of participating hospitals. It also integrates didactic and experiential learning and offers the option of obtaining a master's degree in public health. The program focuses on methodologically rigorous improvement and measurement, with an emphasis on the development and implementation of innovative practice. The operational orientation is intended to foster the professional development of future quality and safety leaders. The purpose of this article is to describe the design and development of the fellowship. © The Author(s) 2014.

Data Quality: 1979 Southeastern Virginia Urban Plume Study (SEV-UPS): Surface and Airborne studies

NASA Technical Reports Server (NTRS)

White, J. H.; Strong, R. B.; Saeger, M. L.; Eaton, W. C.; Lommerdahl, J. B.

1981-01-01

The SEV-UPS field study conducted during August 1979 involved the coordinated air quality data collection efforts of three different organizations operating a total of four aircraft and 12 ground stations. Incorporated into plans for that program were numerous quality assurance activities designed to identify potential hazards for data quality in time for their correction and to take data to allow assessment of the consistency of the data from different stations. The purpose of this study was to document QA procedures that were performed by participating agencies and revise data from all platforms for mutual compatibility. For the latter effort, cases were identified on 21 occasions on seven different days where two or more monitoring systems were operating in the same location at nearly the same time. Data from the systems involved were tabulated in 200 m altitude segments, averaged and compared to detect any bias between measurements made from different systems. The results of these comparisons along with the results of independent performance audits are presented.

Designing climate-resilient rice with ideal grain quality suited for high-temperature stress.

PubMed

Sreenivasulu, Nese; Butardo, Vito M; Misra, Gopal; Cuevas, Rosa Paula; Anacleto, Roslen; Kavi Kishor, Polavarpu B

2015-04-01

To ensure rice food security, the target outputs of future rice breeding programmes should focus on developing climate-resilient rice varieties with emphasis on increased head rice yield coupled with superior grain quality. This challenge is made greater by a world that is increasingly becoming warmer. Such environmental changes dramatically impact head rice and milling yield as well as increasing chalkiness because of impairment in starch accumulation and other storage biosynthetic pathways in the grain. This review highlights the knowledge gained through gene discovery via quantitative trait locus (QTL) cloning and structural-functional genomic strategies to reduce chalk, increase head rice yield, and develop stable lines with optimum grain quality in challenging environments. The newly discovered genes and the knowledge gained on the influence of specific alleles related to stability of grain quality attributes provide a robust platform for marker-assisted selection in breeding to design heat-tolerant rice varieties with superior grain quality. Using the chalkiness trait in rice as a case study, we demonstrate here that the emerging field of systems genetics can help fast-track the identification of novel alleles and gene targets that can be pyramided for the development of environmentally robust rice varieties that possess improved grain quality. © The Author 2015. Published by Oxford University Press on behalf of the Society for Experimental Biology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Extension of quality-by-design concept to the early development phase of pharmaceutical R&D processes.

PubMed

Csóka, Ildikó; Pallagi, Edina; Paál, Tamás L

2018-03-27

Here, we propose the extension of the quality-by-design (QbD) concept to also fit the early development phases of pharmaceuticals by adding elements that are currently widely applied, but not yet included in the QbD model in a structured way. These are the introduction of a 'zero' preformulation phase (i.e., selection of drug substance, possible dosage forms and administration routes based on the evaluated therapeutic need); building in stakeholders' (industry, patient, and regulatory) requirements into the quality target product profile (QTTP); and the use of modern quality management tools during the composition and process design phase [collecting critical quality attributes (CQAs) and selection of CPPs) for (still laboratory-scale) design space (DS) development. Moreover, during industrial scale-up, CQAs (as well as critical process parameters; CPPs) can be changed; however, we recommend that the existing QbD elements are reconsidered and updated after this phase. Copyright © 2018 Elsevier Ltd. All rights reserved.

Application of quality-by-design approach to optimize diallyl disulfide-loaded solid lipid nanoparticles.

PubMed

Talluri, Siddhartha Venkata; Kuppusamy, Gowthamarajan; Karri, Veera Venkata Satyanarayana Reddy; Yamjala, Karthik; Wadhwani, Ashish; Madhunapantula, SubbaRao V; Pindiprolu, Saikiran S S

2017-05-01

The current work was carried out by the principles of quality-by-design approach to develop an optimized solid lipid nanoparticles (SLNs) formulation of diallyl disulfide (DADS) through systematic statistical study. And its antitumor activity of DADS was also evaluated on breast cancer cell lines. To understand the effect of formulation variables (critical parameters) on the responses (critical quality attributes) of SLN, a 3-factor, 3-level Box-Behnken design, was explored to predict the responses such as particle size (Y1) and % entrapment efficiency (EE) (Y2) when concentration of surfactant (X1), amount of lipid (X2), and volume of solvent (X3) were selected as independent variables. Particle size analysis revealed that all the batches were within the nanometer range. DADS was released from the SLN much more rapidly at pH 4.5 than at pH 7.4, which is a desirable characteristic for tumor-targeted drug delivery. The cytotoxicity, reactive oxygen species (ROS), determination revealed that the antitumor activity of DADS is enhanced with SLN compared to DADS-free drug, and apoptosis is the mechanism underlying the cytotoxicity. The present study indicated the remarkable potential of DADS-SLN in enhancing the anticancer effect of DADS in breast cancer cells in vitro.

Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

PubMed Central

2011-01-01

Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

Quality Assurance for Postgraduate Programs: Design of a Model Applied on a University in Chile

ERIC Educational Resources Information Center

Careaga Butter, Marcelo; Meyer Aguilera, Eduardo; Badilla Quintana, María Graciela; Jiménez Pérez, Laura; Sepúlveda Valenzuela, Eileen

2017-01-01

The quality of Education in Chile is a controversial topic that has been in the public debate in the last several years. To ensure quality in graduate programs, accreditation is compulsory. The current article presents a model to improve the process of self-regulation. The main objective was to design a Model of Quality Assurance for Postgraduate…

Sensory modulation and sleep quality among adults with learning disabilities: a quasi-experimental case-control design study.

PubMed

Sharfi, Kineret; Rosenblum, Sara

2015-01-01

Following the International Classification of Functioning, Disability and Health (ICF) concepts, this study examines body functions such as sensory modulation and sleep quality among adults with learning disabilities (LD). One hundred and ten participants, 55 adults with LD and 55 matched controls (mean age 30 years) filled in a socio-demographic questionnaire, the Adults/Adolescents Sensory Profile (AASP), and the Mini Sleep Questionnaire (MSQ). Chi-tests, Mann-Whitney tests, and Kolmogorov-Smirnov tests were conducted to examine group differences related to socio-demographic characteristics and body functions. Correlation and regression analyses were conducted to examine relationships between body functions. Significant differences were found between the groups in: (a) unique socio-demographic variables: high-schools attended, family status and number of children; (b) body functions: low registration and sensory sensitivity (p < .001), sensory avoiding (p = .002), sensory seeking (p = .021) and sleep quality (p < .001). Significant correlations were found between AASP subscale scores and the MSQ final score in each group. Regression analysis revealed that for the entire sample (N = 108), low registration accounted for 10.2% of the variance of sleep quality above group membership (p < .001), while in a separate examination of adults with LD (n = 53), low registration accounted for 19.9% of the variance of sleep quality (p < .001). Adults with LD need to be studied through a health-related perspective such as the ICF model to gain further understanding of their unique characteristics and daily needs. Sensory and sleep functions of adults with LD should be further studied in the context of health related quality of life.

Using system dynamics for collaborative design: a case study

PubMed Central

Elf, Marie; Putilova, Mariya; von Koch, Lena; Öhrn, Kerstin

2007-01-01

Background In order to facilitate the collaborative design, system dynamics (SD) with a group modelling approach was used in the early stages of planning a new stroke unit. During six workshops a SD model was created in a multiprofessional group. Aim To explore to which extent and how the use of system dynamics contributed to the collaborative design process. Method A case study was conducted using several data sources. Results SD supported a collaborative design, by facilitating an explicit description of stroke care process, a dialogue and a joint understanding. The construction of the model obliged the group to conceptualise the stroke care and experimentation with the model gave the opportunity to reflect on care. Conclusion SD facilitated the collaborative design process and should be integrated in the early stages of the design process as a quality improvement tool. PMID:17683519

Design of an instrument to measure the quality of care in Physical Therapy.

PubMed

Cavalheiro, Leny Vieira; Eid, Raquel Afonso Caserta; Talerman, Claudia; Prado, Cristiane do; Gobbi, Fátima Cristina Martorano; Andreoli, Paola Bruno de Araujo

2015-01-01

To design an instrument composed of domains that would demonstrate physical therapy activities and generate a consistent index to represent the quality of care in physical therapy. The methodology Lean Six Sigma was used to design the tool. The discussion involved seven different management groups staff. By means of brainstorming and Cause & Effect Matrix, we set up the process map. Five requirements composed the quality of care index in physical therapy, after application of the tool called Cause & Effect Matrix. The following requirements were assessed: physical therapist performance, care outcome indicator, adherence to physical therapy protocols, measure whether the prognosis and treatment outcome was achieved and Infrastructure. The proposed design allowed evaluating several items related to physical therapy service, enabling customization, reproducibility and benchmarking with other organizations. For management, this index provides the opportunity to identify areas for improvement and the strengths of the team and process of physical therapy care.

Automatic Rotational Sky Quality Meter (R-SQM) Design and Software for Astronomical Observatories

NASA Astrophysics Data System (ADS)

Dogan, E.; Ozbaldan, E. E.; Shameoni, Niaei M.; Yesilyaprak, C.

2016-12-01

We have presented the new design of Sky Quality Meter (SQM) device that is an automatic rotational model of sky quality meter (R-SQM) carried out by DAG (Eastern Anatolia Observatory) Technical Team. R-SQM is required for determining the long-term changes of sky quality of an astronomical observatory and consists of four SQM devices mounted on a rotating shaft with different angles for scanning all sky. This system is controlled by a Raspberry Pi control card and a step motor with its driver and a special software.

Methodological quality of diagnostic accuracy studies on non-invasive coronary CT angiography: influence of QUADAS (Quality Assessment of Diagnostic Accuracy Studies included in systematic reviews) items on sensitivity and specificity.

PubMed

Schueler, Sabine; Walther, Stefan; Schuetz, Georg M; Schlattmann, Peter; Dewey, Marc

2013-06-01

To evaluate the methodological quality of diagnostic accuracy studies on coronary computed tomography (CT) angiography using the QUADAS (Quality Assessment of Diagnostic Accuracy Studies included in systematic reviews) tool. Each QUADAS item was individually defined to adapt it to the special requirements of studies on coronary CT angiography. Two independent investigators analysed 118 studies using 12 QUADAS items. Meta-regression and pooled analyses were performed to identify possible effects of methodological quality items on estimates of diagnostic accuracy. The overall methodological quality of coronary CT studies was merely moderate. They fulfilled a median of 7.5 out of 12 items. Only 9 of the 118 studies fulfilled more than 75 % of possible QUADAS items. One QUADAS item ("Uninterpretable Results") showed a significant influence (P = 0.02) on estimates of diagnostic accuracy with "no fulfilment" increasing specificity from 86 to 90 %. Furthermore, pooled analysis revealed that each QUADAS item that is not fulfilled has the potential to change estimates of diagnostic accuracy. The methodological quality of studies investigating the diagnostic accuracy of non-invasive coronary CT is only moderate and was found to affect the sensitivity and specificity. An improvement is highly desirable because good methodology is crucial for adequately assessing imaging technologies. • Good methodological quality is a basic requirement in diagnostic accuracy studies. • Most coronary CT angiography studies have only been of moderate design quality. • Weak methodological quality will affect the sensitivity and specificity. • No improvement in methodological quality was observed over time. • Authors should consider the QUADAS checklist when undertaking accuracy studies.

Rationale and design of the Multicenter Medication Reconciliation Quality Improvement Study (MARQUIS).

PubMed

Salanitro, Amanda H; Kripalani, Sunil; Resnic, Joanne; Mueller, Stephanie K; Wetterneck, Tosha B; Haynes, Katherine Taylor; Stein, Jason; Kaboli, Peter J; Labonville, Stephanie; Etchells, Edward; Cobaugh, Daniel J; Hanson, David; Greenwald, Jeffrey L; Williams, Mark V; Schnipper, Jeffrey L

2013-06-25

Unresolved medication discrepancies during hospitalization can contribute to adverse drug events, resulting in patient harm. Discrepancies can be reduced by performing medication reconciliation; however, effective implementation of medication reconciliation has proven to be challenging. The goals of the Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS) are to operationalize best practices for inpatient medication reconciliation, test their effect on potentially harmful unintentional medication discrepancies, and understand barriers and facilitators of successful implementation. Six U.S. hospitals are participating in this quality improvement mentored implementation study. Each hospital has collected baseline data on the primary outcome: the number of potentially harmful unintentional medication discrepancies per patient, as determined by a trained on-site pharmacist taking a "gold standard" medication history. With the guidance of their mentors, each site has also begun to implement one or more of 11 best practices to improve medication reconciliation. To understand the effect of the implemented interventions on hospital staff and culture, we are performing mixed methods program evaluation including surveys, interviews, and focus groups of front line staff and hospital leaders. At baseline the number of unintentional medication discrepancies in admission and discharge orders per patient varies by site from 2.35 to 4.67 (mean=3.35). Most discrepancies are due to history errors (mean 2.12 per patient) as opposed to reconciliation errors (mean 1.23 per patient). Potentially harmful medication discrepancies averages 0.45 per patient and varies by site from 0.13 to 0.82 per patient. We discuss several barriers to implementation encountered thus far. In the end, we anticipate that MARQUIS tools and lessons learned have the potential to decrease medication discrepancies and improve patient outcomes. Clinicaltrials.gov identifier NCT01337063.

Rationale and design of the Multicenter Medication Reconciliation Quality Improvement Study (MARQUIS)

PubMed Central

2013-01-01

Background Unresolved medication discrepancies during hospitalization can contribute to adverse drug events, resulting in patient harm. Discrepancies can be reduced by performing medication reconciliation; however, effective implementation of medication reconciliation has proven to be challenging. The goals of the Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS) are to operationalize best practices for inpatient medication reconciliation, test their effect on potentially harmful unintentional medication discrepancies, and understand barriers and facilitators of successful implementation. Methods Six U.S. hospitals are participating in this quality improvement mentored implementation study. Each hospital has collected baseline data on the primary outcome: the number of potentially harmful unintentional medication discrepancies per patient, as determined by a trained on-site pharmacist taking a “gold standard” medication history. With the guidance of their mentors, each site has also begun to implement one or more of 11 best practices to improve medication reconciliation. To understand the effect of the implemented interventions on hospital staff and culture, we are performing mixed methods program evaluation including surveys, interviews, and focus groups of front line staff and hospital leaders. Discussion At baseline the number of unintentional medication discrepancies in admission and discharge orders per patient varies by site from 2.35 to 4.67 (mean=3.35). Most discrepancies are due to history errors (mean 2.12 per patient) as opposed to reconciliation errors (mean 1.23 per patient). Potentially harmful medication discrepancies averages 0.45 per patient and varies by site from 0.13 to 0.82 per patient. We discuss several barriers to implementation encountered thus far. In the end, we anticipate that MARQUIS tools and lessons learned have the potential to decrease medication discrepancies and improve patient outcomes. Trial

Quality in School Environments: A Multiple Case Study of the Diagnosis, Design and Management of Environmental Quality in Five Elementary Schools in the Baltimore City Public Schools from an Action Research Perspective. Volumes I and II.

ERIC Educational Resources Information Center

Lackney, Jeffery A.

Environmental factors are being increasingly recognized as playing a role in school effectiveness and educational outcomes. Volume 1 examines what is known concerning the diagnosis, design, and management of environmental quality in schools, and the perceived relationship between environmental quality and educational outcomes, as revealed in an…

Quality of web-based information on social phobia: a cross-sectional study.

PubMed

Khazaal, Yasser; Fernandez, Sebastien; Cochand, Sophie; Reboh, Isabel; Zullino, Daniele

2008-01-01

The objective of the study is to evaluate the quality of web-based information on social phobia and to investigate particular quality indicators. Two keywords, "Social phobia" and "Social Anxiety Disorder", were entered into five popular World Wide Web search engines. Websites were assessed with a standardized proforma designed to rate sites on the basis of accountability, presentation, interactivity, readability, and content quality. "Health On the Net" (HON) quality label and DISCERN scale scores aiding people without content expertise to assess quality of written health publication were used to verify their efficiency as quality indicators. This study evaluates the quality of web-based information on social phobia. On the 200 identified links, 58 were included. On the basis of outcome measures, the overall quality of the sites turned out to be poor. DISCERN and HON label were indicators of good quality indicators. Accountability criteria were poor indicators of site quality. Although social phobia education Websites for patients are common, educational material highly varies in quality and content. There is a need for better evidence-based information about social phobia on the Web and a need to reconsider the role of accountability criteria as indicators of site quality. Clinicians should advise patients of the HON label and DISCERN as useful indicators of site quality. (c) 2007 Wiley-Liss, Inc.

A Tentative Study on the Evaluation of Community Health Service Quality*

NASA Astrophysics Data System (ADS)

Ma, Zhi-qiang; Zhu, Yong-yue

Community health service is the key point of health reform in China. Based on pertinent studies, this paper constructed an indicator system for the community health service quality evaluation from such five perspectives as visible image, reliability, responsiveness, assurance and sympathy, according to service quality evaluation scale designed by Parasuraman, Zeithaml and Berry. A multilevel fuzzy synthetical evaluation model was constructed to evaluate community health service by fuzzy mathematics theory. The applicability and maneuverability of the evaluation indicator system and evaluation model were verified by empirical analysis.

Testing the quality of images for permanent magnet desktop MRI systems using specially designed phantoms.

PubMed

Qiu, Jianfeng; Wang, Guozhu; Min, Jiao; Wang, Xiaoyan; Wang, Pengcheng

2013-12-21

Our aim was to measure the performance of desktop magnetic resonance imaging (MRI) systems using specially designed phantoms, by testing imaging parameters and analysing the imaging quality. We designed multifunction phantoms with diameters of 18 and 60 mm for desktop MRI scanners in accordance with the American Association of Physicists in Medicine (AAPM) report no. 28. We scanned the phantoms with three permanent magnet 0.5 T desktop MRI systems, measured the MRI image parameters, and analysed imaging quality by comparing the data with the AAPM criteria and Chinese national standards. Image parameters included: resonance frequency, high contrast spatial resolution, low contrast object detectability, slice thickness, geometrical distortion, signal-to-noise ratio (SNR), and image uniformity. The image parameters of three desktop MRI machines could be measured using our specially designed phantoms, and most parameters were in line with MRI quality control criterion, including: resonance frequency, high contrast spatial resolution, low contrast object detectability, slice thickness, geometrical distortion, image uniformity and slice position accuracy. However, SNR was significantly lower than in some references. The imaging test and quality control are necessary for desktop MRI systems, and should be performed with the applicable phantom and corresponding standards.

Quality-by-Design approach to monitor the operation of a batch bioreactor in an industrial avian vaccine manufacturing process.

PubMed

Largoni, Martina; Facco, Pierantonio; Bernini, Donatella; Bezzo, Fabrizio; Barolo, Massimiliano

2015-10-10

Monitoring batch bioreactors is a complex task, due to the fact that several sources of variability can affect a running batch and impact on the final product quality. Additionally, the product quality itself may not be measurable on line, but requires sampling and lab analysis taking several days to be completed. In this study we show that, by using appropriate process analytical technology tools, the operation of an industrial batch bioreactor used in avian vaccine manufacturing can be effectively monitored as the batch progresses. Multivariate statistical models are built from historical databases of batches already completed, and they are used to enable the real time identification of the variability sources, to reliably predict the final product quality, and to improve process understanding, paving the way to a reduction of final product rejections, as well as to a reduction of the product cycle time. It is also shown that the product quality "builds up" mainly during the first half of a batch, suggesting on the one side that reducing the variability during this period is crucial, and on the other side that the batch length can possibly be shortened. Overall, the study demonstrates that, by using a Quality-by-Design approach centered on the appropriate use of mathematical modeling, quality can indeed be built "by design" into the final product, whereas the role of end-point product testing can progressively reduce its importance in product manufacturing. Copyright © 2015 Elsevier B.V. All rights reserved.

NHEXAS PHASE I MARYLAND STUDY--QUALITY SYSTEMS AND IMPLEMENTATION PLAN (HSPH QSIP)

EPA Science Inventory

This document describes the project design and quality systems used by the Maryland Study for NHEXAS Phase 1. It contains the following sections: Project Planning and Organization, Project Implementation Plan, Data Acquisition and Management, Records Usage and Management, Routin...

Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit.

PubMed

Selen, Arzu; Cruañes, Maria T; Müllertz, Anette; Dickinson, Paul A; Cook, Jack A; Polli, James E; Kesisoglou, Filippos; Crison, John; Johnson, Kevin C; Muirhead, Gordon T; Schofield, Timothy; Tsong, Yi

2010-09-01

A biopharmaceutics and Quality by Design (QbD) conference was held on June 10-12, 2009 in Rockville, Maryland, USA to provide a forum and identify approaches for enhancing product quality for patient benefit. Presentations concerned the current biopharmaceutical toolbox (i.e., in vitro, in silico, pre-clinical, in vivo, and statistical approaches), as well as case studies, and reflections on new paradigms. Plenary and breakout session discussions evaluated the current state and envisioned a future state that more effectively integrates QbD and biopharmaceutics. Breakout groups discussed the following four topics: Integrating Biopharmaceutical Assessment into the QbD Paradigm, Predictive Statistical Tools, Predictive Mechanistic Tools, and Predictive Analytical Tools. Nine priority areas, further described in this report, were identified for advancing integration of biopharmaceutics and support a more fundamentally based, integrated approach to setting product dissolution/release acceptance criteria. Collaboration among a broad range of disciplines and fostering a knowledge sharing environment that places the patient's needs as the focus of drug development, consistent with science- and risk-based spirit of QbD, were identified as key components of the path forward.

Design Characteristics Influence Performance of Clinical Prediction Rules in Validation: A Meta-Epidemiological Study.

PubMed

Ban, Jong-Wook; Emparanza, José Ignacio; Urreta, Iratxe; Burls, Amanda

2016-01-01

Many new clinical prediction rules are derived and validated. But the design and reporting quality of clinical prediction research has been less than optimal. We aimed to assess whether design characteristics of validation studies were associated with the overestimation of clinical prediction rules' performance. We also aimed to evaluate whether validation studies clearly reported important methodological characteristics. Electronic databases were searched for systematic reviews of clinical prediction rule studies published between 2006 and 2010. Data were extracted from the eligible validation studies included in the systematic reviews. A meta-analytic meta-epidemiological approach was used to assess the influence of design characteristics on predictive performance. From each validation study, it was assessed whether 7 design and 7 reporting characteristics were properly described. A total of 287 validation studies of clinical prediction rule were collected from 15 systematic reviews (31 meta-analyses). Validation studies using case-control design produced a summary diagnostic odds ratio (DOR) 2.2 times (95% CI: 1.2-4.3) larger than validation studies using cohort design and unclear design. When differential verification was used, the summary DOR was overestimated by twofold (95% CI: 1.2 -3.1) compared to complete, partial and unclear verification. The summary RDOR of validation studies with inadequate sample size was 1.9 (95% CI: 1.2 -3.1) compared to studies with adequate sample size. Study site, reliability, and clinical prediction rule was adequately described in 10.1%, 9.4%, and 7.0% of validation studies respectively. Validation studies with design shortcomings may overestimate the performance of clinical prediction rules. The quality of reporting among studies validating clinical prediction rules needs to be improved.

Systematic review of sensory integration therapy for individuals with disabilities: Single case design studies.

PubMed

Leong, H M; Carter, Mark; Stephenson, Jennifer

2015-12-01

Sensory integration therapy (SIT) is a controversial intervention that is widely used for people with disabilities. Systematic analysis was conducted on the outcomes of 17 single case design studies on sensory integration therapy for people with, or at-risk of, a developmental or learning disability, disorder or delay. An assessment of the quality of methodology of the studies found most used weak designs and poor methodology, with a tendency for higher quality studies to produce negative results. Based on limited comparative evidence, functional analysis-based interventions for challenging behavior were more effective that SIT. Overall the studies do not provide convincing evidence for the efficacy of sensory integration therapy. Given the findings of the present review and other recent analyses it is advised that the use of SIT be limited to experimental contexts. Issues with the studies and possible improvements for future research are discussed including the need to employ designs that allow for adequate demonstration of experimental control. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluating the quality of a cell counting measurement process via a dilution series experimental design.

PubMed

Sarkar, Sumona; Lund, Steven P; Vyzasatya, Ravi; Vanguri, Padmavathy; Elliott, John T; Plant, Anne L; Lin-Gibson, Sheng

2017-12-01

Cell counting measurements are critical in the research, development and manufacturing of cell-based products, yet determining cell quantity with accuracy and precision remains a challenge. Validating and evaluating a cell counting measurement process can be difficult because of the lack of appropriate reference material. Here we describe an experimental design and statistical analysis approach to evaluate the quality of a cell counting measurement process in the absence of appropriate reference materials or reference methods. The experimental design is based on a dilution series study with replicate samples and observations as well as measurement process controls. The statistical analysis evaluates the precision and proportionality of the cell counting measurement process and can be used to compare the quality of two or more counting methods. As an illustration of this approach, cell counting measurement processes (automated and manual methods) were compared for a human mesenchymal stromal cell (hMSC) preparation. For the hMSC preparation investigated, results indicated that the automated method performed better than the manual counting methods in terms of precision and proportionality. By conducting well controlled dilution series experimental designs coupled with appropriate statistical analysis, quantitative indicators of repeatability and proportionality can be calculated to provide an assessment of cell counting measurement quality. This approach does not rely on the use of a reference material or comparison to "gold standard" methods known to have limited assurance of accuracy and precision. The approach presented here may help the selection, optimization, and/or validation of a cell counting measurement process. Published by Elsevier Inc.

Improving quality and safety in nursing homes and home care: the study protocol of a mixed-methods research design to implement a leadership intervention.

PubMed

Wiig, Siri; Ree, Eline; Johannessen, Terese; Strømme, Torunn; Storm, Marianne; Aase, Ingunn; Ullebust, Berit; Holen-Rabbersvik, Elisabeth; Hurup Thomsen, Line; Sandvik Pedersen, Anne Torhild; van de Bovenkamp, Hester; Bal, Roland; Aase, Karina

2018-03-28

Nursing homes and home care face challenges across different countries as people are living longer, often with chronic conditions. There is a lack of knowledge regarding implementation and impact of quality and safety interventions as most research evidence so far is generated in hospitals. Additionally, there is a lack of effective leadership tools for quality and safety improvement work in this context. The aim of the 'Improving Quality and Safety in Primary Care-Implementing a Leadership Intervention in Nursing Homes and Homecare' (SAFE-LEAD) study is to develop and evaluate a research-based leadership guide for managers to increase quality and safety competence. The project applies a mixed-methods design and explores the implications of the leadership guide on managers' and staffs' knowledge, attitudes and practices. Four nursing homes and four home care services from different Norwegian municipalities will participate in the intervention. Surveys, process evaluation (interviews, observations) and document analyses will be conducted to evaluate the implementation and impact of the leadership intervention. A comparative study of Norway and the Netherlands will establish knowledge of the context dependency of the intervention. The study is approved by the Norwegian Centre for Research Data (2017/52324 and 54855). The results will be disseminated through scientific articles, two PhD dissertations, an anthology, presentations at national and international conferences, and in social media, newsletters and in the press. The results will generate knowledge to inform leadership practices in nursing homes and home care. Moreover, the study will build new theory on leadership interventions and the role of contextual factors in nursing homes and home care. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Design of an instrument to measure the quality of care in Physical Therapy

PubMed Central

Cavalheiro, Leny Vieira; Eid, Raquel Afonso Caserta; Talerman, Claudia; do Prado, Cristiane; Gobbi, Fátima Cristina Martorano; Andreoli, Paola Bruno de Araujo

2015-01-01

ABSTRACT Objective: To design an instrument composed of domains that would demonstrate physical therapy activities and generate a consistent index to represent the quality of care in physical therapy. Methods: The methodology Lean Six Sigma was used to design the tool. The discussion involved seven different management groups staff. By means of brainstorming and Cause & Effect Matrix, we set up the process map. Results: Five requirements composed the quality of care index in physical therapy, after application of the tool called Cause & Effect Matrix. The following requirements were assessed: physical therapist performance, care outcome indicator, adherence to physical therapy protocols, measure whether the prognosis and treatment outcome was achieved and Infrastructure. Conclusion: The proposed design allowed evaluating several items related to physical therapy service, enabling customization, reproducibility and benchmarking with other organizations. For management, this index provides the opportunity to identify areas for improvement and the strengths of the team and process of physical therapy care. PMID:26154548

A proposal for assessing study quality: Biomonitoring, Environmental Epidemiology, and Short-lived Chemicals (BEES-C) instrument.

PubMed

LaKind, Judy S; Sobus, Jon R; Goodman, Michael; Barr, Dana Boyd; Fürst, Peter; Albertini, Richard J; Arbuckle, Tye E; Schoeters, Greet; Tan, Yu-Mei; Teeguarden, Justin; Tornero-Velez, Rogelio; Weisel, Clifford P

2014-12-01

The quality of exposure assessment is a major determinant of the overall quality of any environmental epidemiology study. The use of biomonitoring as a tool for assessing exposure to ubiquitous chemicals with short physiologic half-lives began relatively recently. These chemicals present several challenges, including their presence in analytical laboratories and sampling equipment, difficulty in establishing temporal order in cross-sectional studies, short- and long-term variability in exposures and biomarker concentrations, and a paucity of information on the number of measurements required for proper exposure classification. To date, the scientific community has not developed a set of systematic guidelines for designing, implementing and interpreting studies of short-lived chemicals that use biomonitoring as the exposure metric or for evaluating the quality of this type of research for WOE assessments or for peer review of grants or publications. We describe key issues that affect epidemiology studies using biomonitoring data on short-lived chemicals and propose a systematic instrument--the Biomonitoring, Environmental Epidemiology, and Short-lived Chemicals (BEES-C) instrument--for evaluating the quality of research proposals and studies that incorporate biomonitoring data on short-lived chemicals. Quality criteria for three areas considered fundamental to the evaluation of epidemiology studies that include biological measurements of short-lived chemicals are described: 1) biomarker selection and measurement, 2) study design and execution, and 3) general epidemiological study design considerations. We recognize that the development of an evaluative tool such as BEES-C is neither simple nor non-controversial. We hope and anticipate that the instrument will initiate further discussion/debate on this topic. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

A proposal for assessing study quality: Biomonitoring, Environmental Epidemiology, and Short-lived Chemicals (BEES-C) instrument

PubMed Central

LaKind, Judy S.; Sobus, Jon R.; Goodman, Michael; Barr, Dana Boyd; Fürst, Peter; Albertini, Richard J.; Arbuckle, Tye E.; Schoeters, Greet; Tan, Yu-Mei; Teeguarden, Justin; Tornero-Velez, Rogelio; Weisel, Clifford P.

2015-01-01

The quality of exposure assessment is a major determinant of the overall quality of any environmental epidemiology study. The use of biomonitoring as a tool for assessing exposure to ubiquitous chemicals with short physiologic half-lives began relatively recently. These chemicals present several challenges, including their presence in analytical laboratories and sampling equipment, difficulty in establishing temporal order in cross-sectional studies, short- and long-term variability in exposures and biomarker concentrations, and a paucity of information on the number of measurements required for proper exposure classification. To date, the scientific community has not developed a set of systematic guidelines for designing, implementing and interpreting studies of short-lived chemicals that use biomonitoring as the exposure metric or for evaluating the quality of this type of research for WOE assessments or for peer review of grants or publications. We describe key issues that affect epidemiology studies using biomonitoring data on short-lived chemicals and propose a systematic instrument – the Biomonitoring, Environmental Epidemiology, and Short-lived Chemicals (BEES-C) instrument – for evaluating the quality of research proposals and studies that incorporate biomonitoring data on short-lived chemicals. Quality criteria for three areas considered fundamental to the evaluation of epidemiology studies that include biological measurements of short-lived chemicals are described: 1) biomarker selection and measurement, 2) study design and execution, and 3) general epidemiological study design considerations. We recognize that the development of an evaluative tool such as BEES-C is neither simple nor non-controversial. We hope and anticipate that the instrument will initiate further discussion/debate on this topic. PMID:25137624

Quality and customer satisfaction: A case study in Brazil

NASA Astrophysics Data System (ADS)

Barcellos, Paulo Fernando Pinto

The dissertation deals with the case of CEEE-Companhia Estadual de Energia Eletrica, an electric power utility located in Rio Grande do Sul, the southernmost state of Brazil. Customer satisfaction with the services provided by CEEE is investigated within three groups of consumers: residential, commercial, and industrial. The purpose of the dissertation is to find answers to the following research questions: (1) What is service quality in public utilities, and particularly in an electric power company? (2) What service quality dimensions do customers want to be provided and favor the most? (3) How does the market measure service quality? (4) What should be done by companies, and particularly by an electric utility monopoly, to increase the performance of the rendered service? (5) How does this impact customer satisfaction, retention, and intention to recommend? and (6) How do we start a company-wide quality program provided that the resources are scarce and therefore priorities should be set forth? To investigate the posed questions, the study begins with an exploratory survey of CEEE's Board. The survey is followed by qualitative research of the three customer groups. After qualitative analysis of the data is concluded, questionnaires for the quantitative research, as well as hypothetical models, are developed. Dillman's "Total Design Method" is used to design the questionnaires. The basic ACSI (American Customer Satisfaction Model) is used to approach customer satisfaction. Data are processed by PLS (Partial Least Squares) which follows the procedure developed at the National Quality Research Center of the University of Michigan Business School. In summary, commercial customers are the most dissatisfied with the services provided by CEEE, while residential customers are the most satisfied. To improve quality, priority should be placed on commercial customers and include efforts to improve productivity gains throughout the company. Also, CEEE's image should be

Optimum study designs.

PubMed

Gu, C; Rao, D C

2001-01-01

Because simplistic designs will lead to prohibitively large sample sizes, the optimization of genetic study designs is critical for successfully mapping genes for complex diseases. Creative designs are necessary for detecting and amplifying the usually weak signals for complex traits. Two important outcomes of a study design--power and resolution--are implicitly tied together by the principle of uncertainty. Overemphasis on either one may lead to suboptimal designs. To achieve optimality for a particular study, therefore, practical measures such as cost-effectiveness must be used to strike a balance between power and resolution. In this light, the myriad of factors involved in study design can be checked for their effects on the ultimate outcomes, and the popular existing designs can be sorted into building blocks that may be useful for particular situations. It is hoped that imaginative construction of novel designs using such building blocks will lead to enhanced efficiency in finding genes for complex human traits.

Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic.

PubMed

Rathore, Anurag S

2016-05-01

Quality by Design (QbD) is currently receiving increased attention from the pharmaceutical community. As a result, most major biotech manufacturers are in varying stages of implementing QbD. Here, I present a case study that illustrates the step-by-step development using QbD of a purification process for the production of a biosimilar product: granulocyte colony-stimulating factor (GCSF). I also highlight and discuss the advantages that QbD-based process development offers over traditional approaches. The case study is intended to help those who wish to implement QbD towards the development and commercialization of biotech products. Copyright © 2016 Elsevier Ltd. All rights reserved.

Seasonal rationalization of river water quality sampling locations: a comparative study of the modified Sanders and multivariate statistical approaches.

PubMed

Varekar, Vikas; Karmakar, Subhankar; Jha, Ramakar

2016-02-01

The design of surface water quality sampling location is a crucial decision-making process for rationalization of monitoring network. The quantity, quality, and types of available dataset (watershed characteristics and water quality data) may affect the selection of appropriate design methodology. The modified Sanders approach and multivariate statistical techniques [particularly factor analysis (FA)/principal component analysis (PCA)] are well-accepted and widely used techniques for design of sampling locations. However, their performance may vary significantly with quantity, quality, and types of available dataset. In this paper, an attempt has been made to evaluate performance of these techniques by accounting the effect of seasonal variation, under a situation of limited water quality data but extensive watershed characteristics information, as continuous and consistent river water quality data is usually difficult to obtain, whereas watershed information may be made available through application of geospatial techniques. A case study of Kali River, Western Uttar Pradesh, India, is selected for the analysis. The monitoring was carried out at 16 sampling locations. The discrete and diffuse pollution loads at different sampling sites were estimated and accounted using modified Sanders approach, whereas the monitored physical and chemical water quality parameters were utilized as inputs for FA/PCA. The designed optimum number of sampling locations for monsoon and non-monsoon seasons by modified Sanders approach are eight and seven while that for FA/PCA are eleven and nine, respectively. Less variation in the number and locations of designed sampling sites were obtained by both techniques, which shows stability of results. A geospatial analysis has also been carried out to check the significance of designed sampling location with respect to river basin characteristics and land use of the study area. Both methods are equally efficient; however, modified Sanders

Aerodynamic and engineering design of a 1.5 s high quality microgravity drop tower facility

NASA Astrophysics Data System (ADS)

Belser, Valentin; Breuninger, Jakob; Reilly, Matthew; Laufer, René; Dropmann, Michael; Herdrich, Georg; Hyde, Truell; Röser, Hans-Peter; Fasoulas, Stefanos

2016-12-01

Microgravity experiments are essential for research in space science, biology, fluid mechanics, combustion, and material sciences. One way to conduct microgravity experiments on Earth is by using drop tower facilities. These facilities combine a high quality of microgravity, adequate payload masses and have the advantage of virtually unlimited repeatability under same experimental conditions, at a low cost. In a collaboration between the Institute of Space Systems (IRS) at the University of Stuttgart and Baylor University (BU) in Waco, Texas, a new drop tower is currently under development at the Center for Astrophysics, Space Physics and Engineering Research (CASPER). The design parameters of the drop tower ask for at least 1.5 s in free fall duration while providing a quality of at least 10-5 g. Previously, this quality has only been achieved in vacuum drop tower facilities where the capsule experiences virtually zero aerodynamic drag during its free fall. Since this design comes at high costs, a different drop tower design concept, which does not require an evacuated drop shaft, was chosen. It features a dual-capsule system in which the experiment capsule is shielded from aerodynamic forces by surrounding it with a drag shield during the drop. As no other dual-capsule drop tower has been able to achieve a quality as good as or better than 10-5 g previous work optimized the design with an aerodynamic perspective by using computational fluid dynamics (CFD) simulations to determine the ideal shape and size of the outer capsule and to specify the aerodynamically crucial dimensions for the overall system. Experiments later demonstrated that the required quality of microgravity can be met with the proposed design. The main focus of this paper is the mechanical realization of the capsule as well as the development and layout of the surrounding components, such as the release mechanism, the deceleration device and the drop shaft. Because the drop tower facility is a

Quality-by-design-based ultra high performance liquid chromatography related substances method development by establishing the proficient design space for sumatriptan and naproxen combination.

PubMed

Patel, Prinesh N; Karakam, Vijaya Saradhi; Samanthula, Gananadhamu; Ragampeta, Srinivas

2015-10-01

Quality-by-design-based methods hold greater level of confidence for variations and greater success in method transfer. A quality-by-design-based ultra high performance liquid chromatography method was developed for the simultaneous assay of sumatriptan and naproxen along with their related substances. The first screening was performed by fractional factorial design comprising 44 experiments for reversed-phase stationary phases, pH, and organic modifiers. The results of screening design experiments suggested phenyl hexyl column and acetonitrile were the best combination. The method was further optimized for flow rate, temperature, and gradient time by experimental design of 20 experiments and the knowledge space was generated for effect of variable on response (number of peaks ≥ 1.50 - resolution). Proficient design space was generated from knowledge space by applying Monte Carlo simulation to successfully integrate quantitative robustness metrics during optimization stage itself. The final method provided the robust performance which was verified and validated. Final conditions comprised Waters® Acquity phenyl hexyl column with gradient elution using ammonium acetate (pH 4.12, 0.02 M) buffer and acetonitrile at 0.355 mL/min flow rate and 30°C. The developed method separates all 13 analytes within a 15 min run time with fewer experiments compared to the traditional quality-by-testing approach. ©2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Design Characteristics Influence Performance of Clinical Prediction Rules in Validation: A Meta-Epidemiological Study

PubMed Central

Ban, Jong-Wook; Emparanza, José Ignacio; Urreta, Iratxe; Burls, Amanda

2016-01-01

Background Many new clinical prediction rules are derived and validated. But the design and reporting quality of clinical prediction research has been less than optimal. We aimed to assess whether design characteristics of validation studies were associated with the overestimation of clinical prediction rules’ performance. We also aimed to evaluate whether validation studies clearly reported important methodological characteristics. Methods Electronic databases were searched for systematic reviews of clinical prediction rule studies published between 2006 and 2010. Data were extracted from the eligible validation studies included in the systematic reviews. A meta-analytic meta-epidemiological approach was used to assess the influence of design characteristics on predictive performance. From each validation study, it was assessed whether 7 design and 7 reporting characteristics were properly described. Results A total of 287 validation studies of clinical prediction rule were collected from 15 systematic reviews (31 meta-analyses). Validation studies using case-control design produced a summary diagnostic odds ratio (DOR) 2.2 times (95% CI: 1.2–4.3) larger than validation studies using cohort design and unclear design. When differential verification was used, the summary DOR was overestimated by twofold (95% CI: 1.2 -3.1) compared to complete, partial and unclear verification. The summary RDOR of validation studies with inadequate sample size was 1.9 (95% CI: 1.2 -3.1) compared to studies with adequate sample size. Study site, reliability, and clinical prediction rule was adequately described in 10.1%, 9.4%, and 7.0% of validation studies respectively. Conclusion Validation studies with design shortcomings may overestimate the performance of clinical prediction rules. The quality of reporting among studies validating clinical prediction rules needs to be improved. PMID:26730980

Measuring Service Quality in Higher Education: A South African Case Study

ERIC Educational Resources Information Center

Green, Paul

2014-01-01

The goal of this paper is to report on the SERVQUAL gap which causes unsuccessful service delivery at a University of Technology in South Africa. Using a quantitative research design, the study adopts a SERVQUAL model adapted to a tertiary environment containing five dimensions of service quality (tangibles, responsiveness, empathy, assurance, and…

Conceptual design study of a V/STOL lift fan commercial short haul transport

NASA Technical Reports Server (NTRS)

Knight, R. G.; Powell, W. V., Jr.; Prizlow, J. A.

1973-01-01

Conceptual designs of V/STOL lift fan commercial short haul transport aircraft for the 1980-85 time period were studied to determine their technical and economic feasibility. The engine concepts included both integral and remote fans. The scope of the study included definition of the hover control concept for each propulsion system, aircraft design, mass properties, cruise performance, noise and ride qualities evaluation. Economic evaluation was also studied on the basis of direct-operating costs and route structure.

Engineering of a novel adjuvant based on lipid-polymer hybrid nanoparticles: A quality-by-design approach.

PubMed

Rose, Fabrice; Wern, Jeanette Erbo; Ingvarsson, Pall Thor; van de Weert, Marco; Andersen, Peter; Follmann, Frank; Foged, Camilla

2015-07-28

The purpose of this study was to design a novel and versatile adjuvant intended for mucosal vaccination based on biodegradable poly(DL-lactic-co-glycolic acid) (PLGA) nanoparticles (NPs) modified with the cationic surfactant dimethyldioctadecylammonium (DDA) bromide and the immunopotentiator trehalose-6,6'-dibehenate (TDB) (CAF01) to tailor humoral and cellular immunity characterized by antibodies and Th1/Th17 responses. Such responses are important for the protection against diseases caused by intracellular bacteria such as Chlamydia trachomatis and Mycobacterium tuberculosis. The hybrid NPs were engineered using an oil-in-water single emulsion method and a quality-by-design approach was adopted to define the optimal operating space (OOS). Four critical process parameters (CPPs) were identified, including the acetone concentration in the water phase, the stabilizer [polyvinylalcohol (PVA)] concentration, the lipid-to-total solid ratio, and the total concentration. The CPPs were linked to critical quality attributes consisting of the particle size, polydispersity index (PDI), zeta-potential, thermotropic phase behavior, yield and stability. A central composite face-centered design was performed followed by multiple linear regression analysis. The size, PDI, enthalpy of the phase transition and yield were successfully modeled, whereas the models for the zeta-potential and the stability were poor. Cryo-transmission electron microscopy revealed that the main structural effect on the nanoparticle architecture is caused by the use of PVA, and two different morphologies were identified: i) A PLGA core coated with one or several concentric lipid bilayers, and ii) a PLGA nanoshell encapsulating lipid membrane structures. The optimal formulation, identified from the OOS, was evaluated in vivo. The hybrid NPs induced antibody and Th1/Th17 immune responses that were similar in quality and magnitude to the response induced by DDA/TDB liposomes, showing that the adjuvant

Study design and "evidence" in patient-oriented research.

PubMed

Concato, John

2013-06-01

Individual studies in patient-oriented research, whether described as "comparative effectiveness" or using other terms, are based on underlying methodological designs. A simple taxonomy of study designs includes randomized controlled trials on the one hand, and observational studies (such as case series, cohort studies, and case-control studies) on the other. A rigid hierarchy of these design types is a fairly recent phenomenon, promoted as a tenet of "evidence-based medicine," with randomized controlled trials receiving gold-standard status in terms of producing valid results. Although randomized trials have many strengths, and contribute substantially to the evidence base in clinical care, making presumptions about the quality of a study based solely on category of research design is unscientific. Both the limitations of randomized trials as well as the strengths of observational studies tend to be overlooked when a priori assumptions are made. This essay presents an argument in support of a more balanced approach to evaluating evidence, and discusses representative examples from the general medical as well as pulmonary and critical care literature. The simultaneous consideration of validity (whether results are correct "internally") and generalizability (how well results apply to "external" populations) is warranted in assessing whether a study's results are accurate for patients likely to receive the intervention-examining the intersection of clinical and methodological issues in what can be called a medicine-based evidence approach. Examination of cause-effect associations in patient-oriented research should recognize both the strengths and limitations of randomized trials as well as observational studies.

Study on Handing Process and Quality Degradation of Oil Palm Fresh Fruit Bunches (FFB)

NASA Astrophysics Data System (ADS)

Mat Sharif, Zainon Binti; Taib, Norhasnina Binti Mohd; Yusof, Mohd Sallehuddin Bin; Rahim, Mohammad Zulafif Bin; Tobi, Abdul Latif Bin Mohd; Othman, Mohd Syafiq Bin

2017-05-01

The main objective of this study is to determine the relationship between quality of oil palm fresh fruit bunches (FFB) and handling processes. The study employs exploratory and descriptive design, with quantitative approach and purposive sampling using self-administrated questionnaires, were obtained from 30 smallholder respondents from the Southern Region, Peninsular Malaysia. The study reveals that there was a convincing relationship between quality of oil palm fresh fruit bunches (FFB) and handling processes. The main handling process factors influencing quality of oil palm fresh fruit bunches (FFB) were harvesting activity and handling at the plantation area. As a result, it can be deduced that the handling process factors variable explains 82.80% of the variance that reflects the quality of oil palm fresh fruit bunches (FFB). The overall findings reveal that the handling process factors do play a significant role in the quality of oil palm fresh fruit bunches (FFB).

Engineering of budesonide-loaded lipid-polymer hybrid nanoparticles using a quality-by-design approach.

PubMed

Leng, Donglei; Thanki, Kaushik; Fattal, Elias; Foged, Camilla; Yang, Mingshi

2017-08-25

Chronic obstructive pulmonary disease (COPD) is a complex disease, characterized by persistent airflow limitation and chronic inflammation. The purpose of this study was to design lipid-polymer hybrid nanoparticles (LPNs) loaded with the corticosteroid, budesonide, which could potentially be combined with small interfering RNA (siRNA) for COPD management. Here, we prepared LPNs based on the biodegradable polymer poly(dl-lactic-co-glycolic acid) (PLGA) and the cationic lipid dioleyltrimethylammonium propane (DOTAP) using a double emulsion solvent evaporation method. A quality-by-design (QbD) approach was adopted to define the optimal formulation parameters. The quality target product profile (QTPP) of the LPNs was identified based on risk assessment. Two critical formulation parameters (CFPs) were identified, including the theoretical budesonide loading and the theoretical DOTAP loading. The CFPs were linked to critical quality attributes (CQAs), which included the intensity-based hydrodynamic particle diameter (z-average), the polydispersity index (PDI), the zeta-potential, the budesonide encapsulation efficiency, the actual budesonide loading and the DOTAP encapsulation efficiency. A response surface methodology (RSM) was applied for the experimental design to evaluate the influence of the CFPs on the CQAs, and to identify the optimal operation space (OOS). All nanoparticle dispersions displayed monodisperse size distributions (PDI<0.2) with z-averages of approximately 150nm, suggesting that the size is not dependent on the investigated CFPs. In contrast, the zeta-potential was highly dependent on the theoretical DOTAP loading. Upon increased DOTAP loading, the zeta-potential reached a maximal point, after which it remained stable at the maximum value. This suggests that the LPN surface is covered by DOTAP, and that the DOTAP loading is saturable. The actual budesonide loading of the LPNs was mainly dependent on the initial amount of budesonide, and a clear

Latin American Study of Nutrition and Health (ELANS): rationale and study design.

PubMed

Fisberg, M; Kovalskys, I; Gómez, G; Rigotti, A; Cortés, L Y; Herrera-Cuenca, M; Yépez, M C; Pareja, R G; Guajardo, V; Zimberg, I Z; Chiavegatto Filho, A D P; Pratt, M; Koletzko, B; Tucker, K L

2016-01-30

Obesity is growing at an alarming rate in Latin America. Lifestyle behaviours such as physical activity and dietary intake have been largely associated with obesity in many countries; however studies that combine nutrition and physical activity assessment in representative samples of Latin American countries are lacking. The aim of this study is to present the design rationale of the Latin American Study of Nutrition and Health/Estudio Latinoamericano de Nutrición y Salud (ELANS) with a particular focus on its quality control procedures and recruitment processes. The ELANS is a multicenter cross-sectional nutrition and health surveillance study of a nationally representative sample of urban populations from eight Latin American countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Perú and Venezuela). A standard study protocol was designed to evaluate the nutritional intakes, physical activity levels, and anthropometric measurements of 9000 enrolled participants. The study was based on a complex, multistage sample design and the sample was stratified by gender, age (15 to 65 years old) and socioeconomic level. A small-scale pilot study was performed in each country to test the procedures and tools. This study will provide valuable information and a unique dataset regarding Latin America that will enable cross-country comparisons of nutritional statuses that focus on energy and macro- and micronutrient intakes, food patterns, and energy expenditure. Clinical Trials NCT02226627.

Optimal design of monitoring networks for multiple groundwater quality parameters using a Kalman filter: application to the Irapuato-Valle aquifer.

PubMed

Júnez-Ferreira, H E; Herrera, G S; González-Hita, L; Cardona, A; Mora-Rodríguez, J

2016-01-01

A new method for the optimal design of groundwater quality monitoring networks is introduced in this paper. Various indicator parameters were considered simultaneously and tested for the Irapuato-Valle aquifer in Mexico. The steps followed in the design were (1) establishment of the monitoring network objectives, (2) definition of a groundwater quality conceptual model for the study area, (3) selection of the parameters to be sampled, and (4) selection of a monitoring network by choosing the well positions that minimize the estimate error variance of the selected indicator parameters. Equal weight for each parameter was given to most of the aquifer positions and a higher weight to priority zones. The objective for the monitoring network in the specific application was to obtain a general reconnaissance of the water quality, including water types, water origin, and first indications of contamination. Water quality indicator parameters were chosen in accordance with this objective, and for the selection of the optimal monitoring sites, it was sought to obtain a low-uncertainty estimate of these parameters for the entire aquifer and with more certainty in priority zones. The optimal monitoring network was selected using a combination of geostatistical methods, a Kalman filter and a heuristic optimization method. Results show that when monitoring the 69 locations with higher priority order (the optimal monitoring network), the joint average standard error in the study area for all the groundwater quality parameters was approximately 90 % of the obtained with the 140 available sampling locations (the set of pilot wells). This demonstrates that an optimal design can help to reduce monitoring costs, by avoiding redundancy in data acquisition.

E-Service Quality Evaluation on E-Government Website: Case Study BPJS Kesehatan Indonesia

NASA Astrophysics Data System (ADS)

Rasyid, A.; Alfina, I.

2017-01-01

This research intends to develop a model to evaluate the quality of e-services on e-government. The proposed model consists of seven dimensions: web design, reliability, responsiveness, privacy and security, personalization, information, and ease of use. The model is used to measure the quality of the e-registration of BPJS Kesehatan, an Indonesian government health insurance program. The validation and reliability testing show that of the seven dimensions proposed, only four that suitable for the case study. The result shows that the BPJS Kesehatan e-registration service is good in reliability and responsiveness dimensions, while from web design and ease of use dimensions the e-service still needs to be optimized.

Implementing resilience engineering for healthcare quality improvement using the CARE model: a feasibility study protocol.

PubMed

Anderson, J E; Ross, A J; Back, J; Duncan, M; Snell, P; Walsh, K; Jaye, P

2016-01-01

Resilience engineering (RE) is an emerging perspective on safety in complex adaptive systems that emphasises how outcomes emerge from the complexity of the clinical environment. Complexity creates the need for flexible adaptation to achieve outcomes. RE focuses on understanding the nature of adaptations, learning from success and increasing adaptive capacity. Although the philosophy is clear, progress in applying the ideas to quality improvement has been slow. The aim of this study is to test the feasibility of translating RE concepts into practical methods to improve quality by designing, implementing and evaluating interventions based on RE theory. The CARE model operationalises the key concepts and their relationships to guide the empirical investigation. The settings are the Emergency Department and the Older Person's Unit in a large London teaching hospital. Phases 1 and 2 of our work, leading to the development of interventions to improve the quality of care, are described in this paper. Ethical approval has been granted for these phases. Phase 1 will use ethnographic methods, including observation of work practices and interviews with staff, to understand adaptations and outcomes. The findings will be used to collaboratively design, with clinical staff in interactive design workshops, interventions to improve the quality of care. The evaluation phase will be designed and submitted for ethical approval when the outcomes of phases 1 and 2 are known. Study outcomes will be knowledge about the feasibility of applying RE to improve quality, the development of RE theory and a validated model of resilience in clinical work which can be used to guide other applications. Tools, methods and practical guidance for practitioners will also be produced, as well as specific knowledge of the potential effectiveness of the implemented interventions in emergency and older people's care. Further studies to test the application of RE at a larger scale will be required

Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared orodispersible films.

PubMed

Visser, J Carolina; Dohmen, Willem M C; Hinrichs, Wouter L J; Breitkreutz, Jörg; Frijlink, Henderik W; Woerdenbag, Herman J

2015-05-15

The quality by design (QbD) approach was applied for optimizing the formulation of extemporaneously prepared orodispersible films (ODFs) using Design-Expert® Software. The starting formulation was based on earlier experiments and contained the film forming agents hypromellose and carbomer 974P and the plasticizer glycerol (Visser et al., 2015). Trometamol and disodium EDTA were added to stabilize the solution. To optimize this formulation a quality target product profile was established in which critical quality attributes (CQAs) such as mechanical properties and disintegration time were defined and quantified. As critical process parameters (CPP) that were evaluated for their effect on the CQAs the percentage of hypromellose and the percentage of glycerol as well as the drying time were chosen. Response surface methodology (RMS) was used to evaluate the effects of the CPPs on the CQAs of the final product. The main factor affecting tensile strength and Young's modulus was the percentage of glycerol. Elongation at break was mainly influenced by the drying temperature. Disintegration time was found to be sensitive to the percentage of hypromellose. From the results a design space could be created. As long as the formulation and process variables remain within this design space, a product is obtained with desired characteristics and that meets all set quality requirements. Copyright © 2015 Elsevier B.V. All rights reserved.

Assessing the quality of pharmacoeconomic studies in India: a systematic review.

PubMed

Desai, Pooja R; Chandwani, Hitesh S; Rascati, Karen L

2012-09-01

The aim of the study was to evaluate the quality of pharmacoeconomic studies based in India. A literature search was conducted using PubMed, MEDLINE, EconLit, PsycInfo and Google Scholar to identify published work on pharmacoeconomics studies based in India. Articles were included if they were original studies that evaluated pharmaceuticals, were based in India and were conducted between 1990 and 2010. Two reviewers independently reviewed the articles using a subjective 10-point quality scale in addition to the 100-point Quality of Health Economic Studies (QHES) questionnaire. Twenty-nine articles published between 1998 and May 2010 were included in the review. The included articles were published in 23 different journals. Each article was written by an average of five authors. The mean subjective quality score of the 29 articles was 7.8 (standard deviation [SD] = 1.3) and the mean QHES scores for the complete pharmacoeconomic studies (n = 24) was 86 (SD = 6). The majority of authors resided in India (62%) at the time of publication and had a medical background (90%). The quality score was significantly (p ≤ 0.05) related to the country of residence of the primary author (non-India = higher) and the study design (randomized controlled trials = higher). Although the overall quality scores were comparable to (e.g. Nigeria) or higher than (e.g. Zimbabwe) similar studies in other developing countries, key features such as an explicit study perspective and the use of sensitivity analyses were missing in about 40% of the articles. The need for economic evaluation of pharmaceuticals is imperative, especially in developing countries such as India as this helps decision makers allocate scarce resources in a justifiable manner.

[Design and implementation of a questionnaire to evaluate the dietary quality of school meals].

PubMed

de Mateo Silleras, Beatriz; Camina Martín, M Alicia; Ojeda Sainz, Berta; Carreño Enciso, Laura; de la Cruz Marcos, Sandra; Marugán de Miguelsanz, José Manuel; Redondo del Río, Paz

2014-10-03

The school canteen provides a substantial proportion of the daily nutritional intake for many children. There are nutritional standards for school meals, however, it is still difficult to assess the dietary quality. To design a questionnaire for assessing the dietary quality of school meals, quickly and easily. A dietary questionnaire (COMES) was designed on the basis of the current recommendations. COMES consist of 15 items related to the food-frequency and to other characteristics of school meals. Then, a longitudinal prospective study was performed in order to analyze, with COMES, 36 school meals of 4 catering companies from Castilla y León during the academic years 2006-2007 to 2010-2011. Differences in dietary quality menus according to the management system of catering companies (in situ vs. transported) were analyzed by using the Mann-Whitney and the Kruskal-Wallis tests. The significance was reached at p <0,05. The frequency intake of meat, dairy and prepared products was higher to the recommended in 97,2%, 94,4% and 27,8% of the analyzed menus, respectively. By contrast, the frequency intake of fish, fruit, legume, and vegetable garnishes were lower to the recommended in 83,3%, 94,4%, 91,7% and 75% of menus, respectively. Nevertheless, recommendations established by our consensus document for school meals are complied for all food groups, except for dairy and fruits. The variety of foods and culinary techniques were appropriate. No significant differences were found in the COMES score according to the management system (p=0,87), although catering system provides higher dietary quality. A new tool to assess quickly and easily the nutritional quality of school meals has been proposed. The assessment of the frequency intake of the most problematic foods for schoolchildren with this scale is much more demanding than the current recommendations. Even so, menus analyzed showed an acceptable quality in terms of variety of foods and culinary techniques, although

A combined geostatistical-optimization model for the optimal design of a groundwater quality monitoring network

NASA Astrophysics Data System (ADS)

Kolosionis, Konstantinos; Papadopoulou, Maria P.

2017-04-01

Monitoring networks provide essential information for water resources management especially in areas with significant groundwater exploitation due to extensive agricultural activities. In this work, a simulation-optimization framework is developed based on heuristic optimization methodologies and geostatistical modeling approaches to obtain an optimal design for a groundwater quality monitoring network. Groundwater quantity and quality data obtained from 43 existing observation locations at 3 different hydrological periods in Mires basin in Crete, Greece will be used in the proposed framework in terms of Regression Kriging to develop the spatial distribution of nitrates concentration in the aquifer of interest. Based on the existing groundwater quality mapping, the proposed optimization tool will determine a cost-effective observation wells network that contributes significant information to water managers and authorities. The elimination of observation wells that add little or no beneficial information to groundwater level and quality mapping of the area can be obtain using estimations uncertainty and statistical error metrics without effecting the assessment of the groundwater quality. Given the high maintenance cost of groundwater monitoring networks, the proposed tool could used by water regulators in the decision-making process to obtain a efficient network design that is essential.

Riparian buffer design guidelines for water quality and wildlife habitat functions on agricultural landscapes in the Intermountain West

Treesearch

Craig W. Johnson; Susan Buffler

2008-01-01

Intermountain West planners, designers, and resource managers are looking for science-based procedures for determining buffer widths and management techniques that will optimize the benefits riparian ecosystems provide. This study reviewed the riparian buffer literature, including protocols used to determine optimum buffer widths for water quality and wildlife habitat...

Fostering Teachers' Design Expertise in Teacher Design Teams: Conducive Design and Support Activities

ERIC Educational Resources Information Center

Huizinga, Tjark; Handelzalts, Adam; Nieveen, Nienke; Voogt, Joke

2015-01-01

Supporting Teacher Design Teams (TDTs) during local curriculum development efforts is essential. To be able to provide high-quality support, insights are needed about how TDTs carry out design activities and how support is valued by the members of TDTs and how it affects their design expertise. In this study, the design and support processes of…

40 CFR 130.9 - Designation and de-designation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... QUALITY PLANNING AND MANAGEMENT § 130.9 Designation and de-designation. (a) Designation. Areawide planning... specified in Water Quality Management (WQM) plans. Areawide planning agencies shall monitor DMA activities... continue water quality planning activities within the designated boundaries. (c) Impact of de-designation...

A design procedure for the handling qualities optimization of the X-29A aircraft

NASA Technical Reports Server (NTRS)

Bosworth, John T.; Cox, Timothy H.

1989-01-01

The techniques used to improve the pitch-axis handling qualities of the X-29A wing-canard-planform fighter aircraft are reviewed. The aircraft and its FCS are briefly described, and the design method, which works within the existing FCS architecture, is characterized in detail. Consideration is given to the selection of design goals and design variables, the definition and calculation of the cost function, the validation of the mathematical model on the basis of flight-test data, and the validation of the improved design by means of nonlinear simulations. Flight tests of the improved design are shown to verify the simulation results.

Case Study on Quality Education

ERIC Educational Resources Information Center

Habib, Zahida

2011-01-01

Quality of Education, especially at Primary level, is an important issue to be discussed at the International Forum. This study highlights the quality of primary education through a comparison of the quality of Community Model Schools and Govt. Girls Primary Schools in Pakistan. Community Model Schools were established under Girls Primary…

Biomarker discovery study design for type 1 diabetes in The Environmental Determinants of Diabetes in the Young (TEDDY) study.

PubMed

Lee, Hye-Seung; Burkhardt, Brant R; McLeod, Wendy; Smith, Susan; Eberhard, Chris; Lynch, Kristian; Hadley, David; Rewers, Marian; Simell, Olli; She, Jin-Xiong; Hagopian, Bill; Lernmark, Ake; Akolkar, Beena; Ziegler, Anette G; Krischer, Jeffrey P

2014-07-01

The Environmental Determinants of Diabetes in the Young planned biomarker discovery studies on longitudinal samples for persistent confirmed islet cell autoantibodies and type 1 diabetes using dietary biomarkers, metabolomics, microbiome/viral metagenomics and gene expression. This article describes the details of planning The Environmental Determinants of Diabetes in the Young biomarker discovery studies using a nested case-control design that was chosen as an alternative to the full cohort analysis. In the frame of a nested case-control design, it guides the choice of matching factors, selection of controls, preparation of external quality control samples and reduction of batch effects along with proper sample allocation. Our design is to reduce potential bias and retain study power while reducing the costs by limiting the numbers of samples requiring laboratory analyses. It also covers two primary end points (the occurrence of diabetes-related autoantibodies and the diagnosis of type 1 diabetes). The resulting list of case-control matched samples for each laboratory was augmented with external quality control samples. Copyright © 2013 John Wiley & Sons, Ltd.

Policy for Establishing Separate Air Quality Designations for Areas of Indian Country Memorandum

EPA Pesticide Factsheets

This 2011 memorandum provides EPA's policy regarding designating areas of Indian country separately from adjacent areas for the National Ambient Air Quality Standards (NAAQS), when requested by the relevant tribe for a particular area of Indian country.

Quality Matters™: An Educational Input in an Ongoing Design-Based Research Project

ERIC Educational Resources Information Center

Adair, Deborah; Shattuck, Kay

2015-01-01

Quality Matters (QM) has been transforming established best practices and online education-based research into an applicable, scalable course level improvement process for the last decade. In this article, the authors describe QM as an ongoing design-based research project and an educational input for improving online education.

Quality of Communication Life in Adolescents with High-Functioning Autism and Asperger Syndrome: A Feasibility Study

ERIC Educational Resources Information Center

Burgess, Sloane; Turkstra, Lyn S.

2010-01-01

Purpose: This study was designed to evaluate the feasibility of using the American Speech-Language-Hearing Association's Quality of Communication Life Scale (QCL; Paul et al., 2004) for a group of individuals with developmental communication disorders--adolescents with high-functioning autism/Asperger syndrome (HFA/AS). Perceptions of quality of…

On designing for quality

NASA Technical Reports Server (NTRS)

Vajingortin, L. D.; Roisman, W. P.

1991-01-01

The problem of ensuring the required quality of products and/or technological processes often becomes more difficult due to the fact that there is not general theory of determining the optimal sets of value of the primary factors, i.e., of the output parameters of the parts and units comprising an object and ensuring the correspondence of the object's parameters to the quality requirements. This is the main reason for the amount of time taken to finish complex vital article. To create this theory, one has to overcome a number of difficulties and to solve the following tasks: the creation of reliable and stable mathematical models showing the influence of the primary factors on the output parameters; finding a new technique of assigning tolerances for primary factors with regard to economical, technological, and other criteria, the technique being based on the solution of the main problem; well reasoned assignment of nominal values for primary factors which serve as the basis for creating tolerances. Each of the above listed tasks is of independent importance. An attempt is made to give solutions for this problem. The above problem dealing with quality ensuring an mathematically formalized aspect is called the multiple inverse problem.

The Role of Habitability Studies in Space Facility and Vehicle Design

NASA Technical Reports Server (NTRS)

Adams, Constance M.

1999-01-01

This document is a viewgraph presentation which reviews the role of the space architect in designing a space vehicle with habitability as a chief concern. Habitability is composed of the qualities of the environment or system which support the crew in working and living. All the impacts from habitability are interdependent; i.e., impacts to well-being can impact performance, safety or efficiency. After reviewing the issues relating to habitability the presentation discusses the application of these issues in two case studies. The first studies the Bio-Plex Hab chamber which includes designs of the living and working areas. The second case study is the ISS-TransHab which is being studied as a prototype for Mars transit.

Conceptual design study of a 1985 commercial STOL tilt rotor transport

NASA Technical Reports Server (NTRS)

Widdison, C. A.; Magee, J. P.; Alexander, H. R.

1974-01-01

Results of conceptual engineering design studies of a STOL tilt rotor commercial aircraft for the 1985 time frame are presented. The details of aircraft size, performance, flying qualities, noise, and cost are included. The savings in terms of fuel economy resulting from STOL operations compared with VTOL vehicles are determined.

Assessment and Quality Social Studies

ERIC Educational Resources Information Center

Savage, Tom V.

2003-01-01

Those anonymous individuals who develop high-stakes tests by which educational quality is measured exercise great influence in defining educational quality. In this article, the author examines the impact of high-stakes testing on the welfare of the children and the quality of social studies instruction. He presents the benefits and drawbacks of…

Design and Development of a Nearable Wireless System to Control Indoor Air Quality and Indoor Lighting Quality.

PubMed

Salamone, Francesco; Belussi, Lorenzo; Danza, Ludovico; Galanos, Theodore; Ghellere, Matteo; Meroni, Italo

2017-05-04

The article describes the results of the project "open source smart lamp" aimed at designing and developing a smart object able to manage and control the indoor environmental quality (IEQ) of the built environment. A first version of this smart object, built following a do-it-yourself (DIY) approach using a microcontroller, an integrated temperature and relative humidity sensor, and techniques of additive manufacturing, allows the adjustment of the indoor thermal comfort quality (ICQ), by interacting directly with the air conditioner. As is well known, the IEQ is a holistic concept including indoor air quality (IAQ), indoor lighting quality (ILQ) and acoustic comfort, besides thermal comfort. The upgrade of the smart lamp bridges the gap of the first version of the device providing the possibility of interaction with the air exchange unit and lighting system in order to get an overview of the potential of a nearable device in the management of the IEQ. The upgraded version was tested in a real office equipped with mechanical ventilation and an air conditioning system. This office was occupied by four workers. The experiment is compared with a baseline scenario and the results show how the application of the nearable device effectively optimizes both IAQ and ILQ.

Design and Development of a Nearable Wireless System to Control Indoor Air Quality and Indoor Lighting Quality

PubMed Central

Salamone, Francesco; Belussi, Lorenzo; Danza, Ludovico; Galanos, Theodore; Ghellere, Matteo; Meroni, Italo

2017-01-01

The article describes the results of the project “open source smart lamp” aimed at designing and developing a smart object able to manage and control the indoor environmental quality (IEQ) of the built environment. A first version of this smart object, built following a do-it-yourself (DIY) approach using a microcontroller, an integrated temperature and relative humidity sensor, and techniques of additive manufacturing, allows the adjustment of the indoor thermal comfort quality (ICQ), by interacting directly with the air conditioner. As is well known, the IEQ is a holistic concept including indoor air quality (IAQ), indoor lighting quality (ILQ) and acoustic comfort, besides thermal comfort. The upgrade of the smart lamp bridges the gap of the first version of the device providing the possibility of interaction with the air exchange unit and lighting system in order to get an overview of the potential of a nearable device in the management of the IEQ. The upgraded version was tested in a real office equipped with mechanical ventilation and an air conditioning system. This office was occupied by four workers. The experiment is compared with a baseline scenario and the results show how the application of the nearable device effectively optimizes both IAQ and ILQ. PMID:28471398

Quality of life, symptom distress, and social support among renal transplant recipients in Southern Taiwan: a correlational study.

PubMed

Chen, Wan-Chi; Chen, Ching-Huey; Lee, Po-Chang; Wang, Wen-Ling

2007-12-01

Quality of life is an important indicator for evaluating therapeutic outcomes and mortality in patients with end-stage renal disease. Few studies have explored the impact of symptom distress and social support on quality of life in this population. A correlational study was designed to examine the influence of symptom distress, social support and demographic characteristics on quality of life in renal transplant recipients. A convenience sample of 113 renal transplant recipients was recruited from a medical center in Southern Taiwan. A structured questionnaire was used to collect data. This four-part tool included: Quality of Life Index--Kidney Transplant Version III, Physical Symptom Distress Scale, Social Support Scale, and demographic characteristics. Data were analyzed by descriptive and inferential statistics (SPSS 10.1 statistical package). Percentage, rank, mean and standard deviation, t-tests, chi-square, ANOVA, Pearson's correlation and multiple regression were computed. Results showed that renal transplant recipients had a moderate quality of life. Social support and symptom distress, age, employment status, and household income significantly explained 28.8% of the variance in quality of life. Findings suggest implications for interventional programming and research aimed toward improving quality of life, including individual and family-based approaches designed to enhance recipients' social support and address effective management of symptoms. Recruiting a transplant clinical nurse specialist to design and implement an intervention program also is recommended.

Design of a digital ride quality augmentation system for commuter aircraft

NASA Technical Reports Server (NTRS)

Hammond, T. A.; Amin, S. P.; Paduano, J. D.; Downing, D. R.

1984-01-01

Commuter aircraft typically have low wing loadings, and fly at low altitudes, and so they are susceptible to undesirable accelerations caused by random atmospheric turbulence. Larger commercial aircraft typically have higher wing loadings and fly at altitudes where the turbulence level is lower, and so they provide smoother rides. This project was initiated based on the goal of making the ride of the commuter aircraft as smooth as the ride experienced on the major commercial airliners. The objectives of this project were to design a digital, longitudinal mode ride quality augmentation system (RQAS) for a commuter aircraft, and to investigate the effect of selected parameters on those designs.

Sustainable microbial water quality monitoring programme design using phage-lysis and multivariate techniques.

PubMed

Nnane, Daniel Ekane

2011-11-15

Contamination of surface waters is a pervasive threat to human health, hence, the need to better understand the sources and spatio-temporal variations of contaminants within river catchments. River catchment managers are required to sustainably monitor and manage the quality of surface waters. Catchment managers therefore need cost-effective low-cost long-term sustainable water quality monitoring and management designs to proactively protect public health and aquatic ecosystems. Multivariate and phage-lysis techniques were used to investigate spatio-temporal variations of water quality, main polluting chemophysical and microbial parameters, faecal micro-organisms sources, and to establish 'sentry' sampling sites in the Ouse River catchment, southeast England, UK. 350 river water samples were analysed for fourteen chemophysical and microbial water quality parameters in conjunction with the novel human-specific phages of Bacteroides GB-124 (Bacteroides GB-124). Annual, autumn, spring, summer, and winter principal components (PCs) explained approximately 54%, 75%, 62%, 48%, and 60%, respectively, of the total variance present in the datasets. Significant loadings of Escherichia coli, intestinal enterococci, turbidity, and human-specific Bacteroides GB-124 were observed in all datasets. Cluster analysis successfully grouped sampling sites into five clusters. Importantly, multivariate and phage-lysis techniques were useful in determining the sources and spatial extent of water contamination in the catchment. Though human faecal contamination was significant during dry periods, the main source of contamination was non-human. Bacteroides GB-124 could potentially be used for catchment routine microbial water quality monitoring. For a cost-effective low-cost long-term sustainable water quality monitoring design, E. coli or intestinal enterococci, turbidity, and Bacteroides GB-124 should be monitored all-year round in this river catchment. Copyright © 2011 Elsevier B.V. All

Landsat image data quality studies

NASA Technical Reports Server (NTRS)

Schueler, C. F.; Salomonson, V. V.

1985-01-01

Preliminary results of the Landsat-4 Image Data Quality Analysis (LIDQA) program to characterize the data obtained using the Thematic Mapper (TM) instrument on board the Landsat-4 and Landsat-5 satellites are reported. TM design specifications were compared to the obtained data with respect to four criteria, including spatial resolution; geometric fidelity; information content; and image relativity to Multispectral Scanner (MSS) data. The overall performance of the TM was rated excellent despite minor instabilities and radiometric anomalies in the data. Spatial performance of the TM exceeded design specifications in terms of both image sharpness and geometric accuracy, and the image utility of the TM data was at least twice as high as MSS data. The separability of alfalfa and sugar beet fields in a TM image is demonstrated.

Evaluating a complex, multi-site, community-based program to improve healthcare quality: the summative research design for the Aligning Forces for Quality initiative.

PubMed

Scanlon, Dennis P; Wolf, Laura J; Alexander, Jeffrey A; Christianson, Jon B; Greene, Jessica; Jean-Jacques, Muriel; McHugh, Megan; Shi, Yunfeng; Leitzell, Brigitt; Vanderbrink, Jocelyn M

2016-08-01

The Aligning Forces for Quality (AF4Q) initiative was the Robert Wood Johnson Foundation's (RWJF's) signature effort to increase the overall quality of healthcare in targeted communities throughout the country. In addition to sponsoring this 16-site complex program, RWJF funded an independent scientific evaluation to support objective research on the initiative's effectiveness and contributions to basic knowledge in 5 core programmatic areas. The research design, data, and challenges faced during the summative evaluation phase of this near decade-long program are discussed. A descriptive overview of the summative research design and its development for a multi-site, community-based, healthcare quality improvement initiative is provided. The summative research design employed by the evaluation team is discussed. The evaluation team's summative research design involved a data-driven assessment of the effectiveness of the AF4Q program at large, assessments of the impact of AF4Q in the specific programmatic areas, and an assessment of how the AF4Q alliances were positioned for the future at the end of the program. The AF4Q initiative was the largest privately funded community-based healthcare improvement initiative in the United States to date and was implemented at a time of rapid change in national healthcare policy. The implementation of large-scale, multi-site initiatives is becoming an increasingly common approach for addressing problems in healthcare. The summative evaluation research design for the AF4Q initiative, and the lessons learned from its approach, may be valuable to others tasked with evaluating similarly complex community-based initiatives.

Continuous production of fenofibrate solid lipid nanoparticles by hot-melt extrusion technology: a systematic study based on a quality by design approach.

PubMed

Patil, Hemlata; Feng, Xin; Ye, Xingyou; Majumdar, Soumyajit; Repka, Michael A

2015-01-01

This contribution describes a continuous process for the production of solid lipid nanoparticles (SLN) as drug-carrier systems via hot-melt extrusion (HME). Presently, HME technology has not been used for the manufacturing of SLN. Generally, SLN are prepared as a batch process, which is time consuming and may result in variability of end-product quality attributes. In this study, using Quality by Design (QbD) principles, we were able to achieve continuous production of SLN by combining two processes: HME technology for melt-emulsification and high-pressure homogenization (HPH) for size reduction. Fenofibrate (FBT), a poorly water-soluble model drug, was incorporated into SLN using HME-HPH methods. The developed novel platform demonstrated better process control and size reduction compared to the conventional process of hot homogenization (batch process). Varying the process parameters enabled the production of SLN below 200 nm. The dissolution profile of the FBT SLN prepared by the novel HME-HPH method was faster than that of the crude FBT and a micronized marketed FBT formulation. At the end of a 5-h in vitro dissolution study, a SLN formulation released 92-93% of drug, whereas drug release was approximately 65 and 45% for the marketed micronized formulation and crude drug, respectively. Also, pharmacokinetic study results demonstrated a statistical increase in Cmax, Tmax, and AUC0-24 h in the rate of drug absorption from SLN formulations as compared to the crude drug and marketed micronized formulation. In summary, the present study demonstrated the potential use of hot-melt extrusion technology for continuous and large-scale production of SLN.

Conceptual design study of 1985 commercial tilt rotor transports. Volume 3: STOL design summary

NASA Technical Reports Server (NTRS)

Sambell, K. W.

1976-01-01

A conceptual design study is presented of 1,985 commercial tilt rotor STOL transports for a NASA 200 n. mi. (370 km) STOL Mission. A 100-passenger STOL Variant (Bell D313) of the Phase I VTOL Tilt Rotor Aircraft is defined. Aircraft characteristics are given; with the aircraft redesigned to meet 2,000-foot (610 m) field criteria, with emphasis on low fuel consumption and low direct operating cost. The 100-passenger STOL Tilt Rotor Aircraft was analyzed for performance, weights, economics, handling qualities, noise footprint and aeroelastic stability.

Principals' Perspectives on Designing, Implementing, and Sustaining a Professional Learning Community: A Qualitative Study

ERIC Educational Resources Information Center

Bozzini, Michelle D.

2017-01-01

This qualitative study explored how elementary school principals design, implement, and sustain high quality professional development through the use of professional learning communities (PLCs) in order to enhance teaching and learning. The researcher revealed the principal's important role in the design, implementation, and sustainability of a…

Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities.

PubMed

Jovanović, Marko; Rakić, Tijana; Tumpa, Anja; Jančić Stojanović, Biljana

2015-06-10

This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm × 4.6 mm, 5 μm particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 °C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm. Copyright © 2015 Elsevier B.V. All rights reserved.

Fuel quality processing study, volume 1

NASA Astrophysics Data System (ADS)

Ohara, J. B.; Bela, A.; Jentz, N. E.; Syverson, H. T.; Klumpe, H. W.; Kessler, R. E.; Kotzot, H. T.; Loran, B. L.

1981-04-01

A fuel quality processing study to provide a data base for an intelligent tradeoff between advanced turbine technology and liquid fuel quality, and also, to guide the development of specifications of future synthetic fuels anticipated for use in the time period 1985 to 2000 is given. Four technical performance tests are discussed: on-site pretreating, existing refineries to upgrade fuels, new refineries to upgrade fuels, and data evaluation. The base case refinery is a modern Midwest refinery processing 200,000 BPD of a 60/40 domestic/import petroleum crude mix. The synthetic crudes used for upgrading to marketable products and turbine fuel are shale oil and coal liquids. Of these syncrudes, 50,000 BPD are processed in the existing petroleum refinery, requiring additional process units and reducing petroleum feed, and in a new refinery designed for processing each syncrude to produce gasoline, distillate fuels, resid fuels, and turbine fuel, JPGs and coke. An extensive collection of synfuel properties and upgrading data was prepared for the application of a linear program model to investigate the most economical production slate meeting petroleum product specifications and turbine fuels of various quality grades. Technical and economic projections were developed for 36 scenarios, based on 4 different crude feeds to either modified existing or new refineries operated in 2 different modes to produce 7 differing grades of turbine fuels. A required product selling price of turbine fuel for each processing route was calculated. Procedures and projected economics were developed for on-site treatment of turbine fuel to meet limitations of impurities and emission of pollutants.

Fuel quality processing study, volume 1

NASA Technical Reports Server (NTRS)

Ohara, J. B.; Bela, A.; Jentz, N. E.; Syverson, H. T.; Klumpe, H. W.; Kessler, R. E.; Kotzot, H. T.; Loran, B. L.

1981-01-01

A fuel quality processing study to provide a data base for an intelligent tradeoff between advanced turbine technology and liquid fuel quality, and also, to guide the development of specifications of future synthetic fuels anticipated for use in the time period 1985 to 2000 is given. Four technical performance tests are discussed: on-site pretreating, existing refineries to upgrade fuels, new refineries to upgrade fuels, and data evaluation. The base case refinery is a modern Midwest refinery processing 200,000 BPD of a 60/40 domestic/import petroleum crude mix. The synthetic crudes used for upgrading to marketable products and turbine fuel are shale oil and coal liquids. Of these syncrudes, 50,000 BPD are processed in the existing petroleum refinery, requiring additional process units and reducing petroleum feed, and in a new refinery designed for processing each syncrude to produce gasoline, distillate fuels, resid fuels, and turbine fuel, JPGs and coke. An extensive collection of synfuel properties and upgrading data was prepared for the application of a linear program model to investigate the most economical production slate meeting petroleum product specifications and turbine fuels of various quality grades. Technical and economic projections were developed for 36 scenarios, based on 4 different crude feeds to either modified existing or new refineries operated in 2 different modes to produce 7 differing grades of turbine fuels. A required product selling price of turbine fuel for each processing route was calculated. Procedures and projected economics were developed for on-site treatment of turbine fuel to meet limitations of impurities and emission of pollutants.

Office of Student Financial Aid Quality Improvement Program: Design and Implementation Plan.

ERIC Educational Resources Information Center

Advanced Technology, Inc., Reston, VA.

The purpose and direction of the quality improvement program of the U.S. Department of Education's Office of Student Financial Aid (OSFA) are described. The improvement program was designed to develop a systematic approach to identify, measure, and correct errors in the student aid delivery system. Information is provided on the general approach…

An analysis of the influence of framework aspects on the study design of health economic modeling evaluations.

PubMed

Gurtner, Sebastian

2013-04-01

Research and practical guidelines have many implications for how to structure a health economic study. A major focus in recent decades has been the quality of health economic research. In practice, the factors influencing a study design are not limited to the quest for quality. Moreover, the framework of the study is important. This research addresses three major questions related to these framework aspects. First, we want to know whether the design of health economic studies has changed over time. Second, we want to know how the subject of a study, whether it is a process or product innovation, influences the parameters of the study design. Third, one of the most important questions we will answer is whether and how the study's source of funding has an impact on the design of the research. To answer these questions, a total of 234 health economic studies were analyzed using a correspondence analysis and a logistic regression analysis. All three categories of framework factors have an influence on the aspects of the study design. Health economic studies have evolved over time, leading to the use of more advanced methods like complex sensitivity analyses. Additionally, the patient's point of view has increased in importance. The evaluation of product innovations has focused more on utility concepts. On the other hand, the source of funding may influence only a few aspects of the study design, such as the use of evaluation methods, the source of data, and the use of certain utility measures. The most important trends in health care, such as the emphasis on the patients' point of view, become increasingly established in health economic evaluations with the passage of time. Although methodological challenges remain, modern information and communication technologies provide a basis for increasing the complexity and quality of health economic studies if used frequently.

Quality Circles in Higher Education: Quality, Satisfaction, and Climate.

ERIC Educational Resources Information Center

Kay, Carol; Healy, Margaret

The effect of quality circles at Iowa State University on absenteeism, performance evaluation, perceptions of the organization climate, job satisfaction, and perceived opportunities for professional and personal growth was measured in this study. The process of quality circles is designed to promote job fulfillment and organizational productivity…

The Quality of Medication Use in Older Adults: Methods of a Longitudinal Study

PubMed Central

Roth, Mary T.; Moore, Charity G.; Ivey, Jena L.; Esserman, Denise A.; Campbell, William H.; Weinberger, Morris

2009-01-01

Background The quality of medication use in older adults is a recurring problem of substantial concern. Efforts to both measure and improve the quality of medication use often define quality too narrowly and fall short of addressing the complexity of an older adult's medication regimen. Objective In an effort to more comprehensively define the quality of medication use in older adults, we conducted a prospective cohort study to: 1) describe the quality of medication use in community-residing older adults at baseline, examining differences between Whites and African Americans; 2) examine the effect of race on medication-related problems[mtr1], and 3) assess the change in quality medication use between Whites and African Americans over time. This paper presents the research design and methods of this longitudinal study. Methods We interviewed 100 White and 100 African-American community-residing older adults three times over one year (baseline, 6, and 12 months). We oversampled African Americans so that we could estimate racial differences in the quality of medication use. We collected information on the quality of medication use, relying on a clinical pharmacist's assessment of quality and the Assessing Care of Vulnerable Elders (ACOVE) quality indicators. We also collected data on demographic characteristics, health literacy, functional status, and participant-reported drug therapy concerns. Results Two hundred older adults were enrolled into the study and completed a baseline visit. Of the 200, 92% completed the 6-month visit (n=183) and 88% completed the 12-month visit (n=176). We present baseline demographic characteristics for the 200 older adults enrolled in the study. Conclusion This longitudinal study is an initial step toward developing more comprehensive, patient-centered measures and interventions to improve the quality of medication use in older adults. PMID:19028378

Elevated guideway cost-ride quality studies for group rapid transit systems

DOT National Transportation Integrated Search

1977-10-01

A methodology is developed for relating cost to ride quality in elevated guideway : system design, based upon directly relating guideway structural properties and : construction tolerances to both cost and ride quality. It is illustrated in detail : ...

Influence of study design on digital pathology image quality evaluation: the need to define a clinical task

PubMed Central

Platiša, Ljiljana; Brantegem, Leen Van; Kumcu, Asli; Ducatelle, Richard; Philips, Wilfried

2017-01-01

Abstract. Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors’ success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to

Influence of study design on digital pathology image quality evaluation: the need to define a clinical task.

PubMed

Platiša, Ljiljana; Brantegem, Leen Van; Kumcu, Asli; Ducatelle, Richard; Philips, Wilfried

2017-04-01

Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors' success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to their criteria

Factors influencing nurse-assessed quality nursing care: A cross-sectional study in hospitals.

PubMed

Liu, Ying; Aungsuroch, Yupin

2018-04-01

To propose a hypothesized theoretical model and apply it to examine the structural relationships among work environment, patient-to-nurse ratio, job satisfaction, burnout, intention to leave and quality nursing care. Improving quality nursing care is a first consideration in nursing management globally. A better understanding of factors influencing quality nursing care can help hospital administrators implement effective programmes to improve quality of services. Although certain bivariate correlations have been found between selected factors and quality nursing care in different study models, no studies have examined the relationships among work environment, patient-to-nurse ratio, job satisfaction, burnout, intention to leave and quality nursing care in a more comprehensive theoretical model. A cross-sectional survey. The questionnaires were collected from 510 Chinese nurses in four Chinese tertiary hospitals in January 2015. The validity and internal consistency reliability of research instruments were evaluated. Structural equation modelling was used to test a theoretical model. The findings revealed that the data supported the theoretical model. Work environment had a large total effect size on quality nursing care. Burnout largely and directly influenced quality nursing care, which was followed by work environment and patient-to-nurse ratio. Job satisfaction indirectly affected quality nursing care through burnout. This study shows how work environment past burnout and job satisfaction influences quality nursing care. Apart from nurses' work conditions of work environment and patient-to-nurse ratio, hospital administrators should pay more attention to nurse outcomes of job satisfaction and burnout when designing intervention programmes to improve quality nursing care. © 2017 John Wiley & Sons Ltd.

Design of monoalcohol - Copolymer system for high quality silver nanowires.

PubMed

Sugiyama, Shintaro; Yokoyama, Shun; Cuya Huaman, Jhon L; Ida, Shohei; Matsumoto, Takatoshi; Kodama, Daisuke; Sato, Kimitaka; Miyamura, Hiroshi; Hirokawa, Yoshitsugu; Balachandran, Jeyadevan

2018-05-14

Research to improve the dimensional properties of silver nanowires (Ag NWs) for transparent conductive film (TCF) applications are being carried out intensively. However, the protocol for the designed synthesis of high-quality Ag NWs is yet to be developed due to the inadequacy of knowledge on the role of parameters. Here, we attempt to elucidate the role played by the parameters and propose a monoalcohol-copolymer based system for the designed synthesis of Ag NWs superior in quality to the one synthesized using conventional ethylene glycol (EG)-polyvinylpyrrolidone (PVP) system. The key findings of the study are as follows: (1) the solubility of Ag source and the partially formed AgCl particles in monoalcohols was found to play an important role not only in the reduction to metallic Ag but also on the uniaxial growth, (2) the adsorption of capping agents on Ag NWs was carried through O and N atoms in the base molecule and their binding energies indicated that the strength is the key parameter to obtain Ag NWs with high aspect ratio, (3) the properties of nanowire could be enhanced through copolymerization of VP and base molecules that have O- and N-based ligands, and (4) the influence of copolymerization on the physical and chemical properties of the surface active agent has been theoretically and experimentally verified. Consequently, we succeeded in the development of a new technique to synthesize high yield of Ag NWs with improved aspect ratio than EG-PVP system by using benzyl alcohol as reducing solvent and N-vinylpyrrolidone/N,N-diethylaminoethyl metacrylate copolymer as a capping agent. The optical transmittance and electrical resistivity of TCFs prepared using the Ag NWs with an average diameter of 43 nm, and an average length of 13 μm were 98.6% and R: 49.1 Ω/□, respectively. Copyright © 2018 Elsevier Inc. All rights reserved.

Quality by design for herbal drugs: a feedforward control strategy and an approach to define the acceptable ranges of critical quality attributes.

PubMed

Yan, Binjun; Li, Yao; Guo, Zhengtai; Qu, Haibin

2014-01-01

The concept of quality by design (QbD) has been widely accepted and applied in the pharmaceutical manufacturing industry. There are still two key issues to be addressed in the implementation of QbD for herbal drugs. The first issue is the quality variation of herbal raw materials and the second issue is the difficulty in defining the acceptable ranges of critical quality attributes (CQAs). To propose a feedforward control strategy and a method for defining the acceptable ranges of CQAs for the two issues. In the case study of the ethanol precipitation process of Danshen (Radix Salvia miltiorrhiza) injection, regression models linking input material attributes and process parameters to CQAs were built first and an optimisation model for calculating the best process parameters according to the input materials was established. Then, the feasible material space was defined and the acceptable ranges of CQAs for the previous process were determined. In the case study, satisfactory regression models were built with cross-validated regression coefficients (Q(2) ) all above 91 %. The feedforward control strategy was applied successfully to compensate the quality variation of the input materials, which was able to control the CQAs in the 90-110 % ranges of the desired values. In addition, the feasible material space for the ethanol precipitation process was built successfully, which showed the acceptable ranges of the CQAs for the concentration process. The proposed methodology can help to promote the implementation of QbD for herbal drugs. Copyright © 2013 John Wiley & Sons, Ltd.

Network-based production quality control

NASA Astrophysics Data System (ADS)

Kwon, Yongjin; Tseng, Bill; Chiou, Richard

2007-09-01

This study investigates the feasibility of remote quality control using a host of advanced automation equipment with Internet accessibility. Recent emphasis on product quality and reduction of waste stems from the dynamic, globalized and customer-driven market, which brings opportunities and threats to companies, depending on the response speed and production strategies. The current trends in industry also include a wide spread of distributed manufacturing systems, where design, production, and management facilities are geographically dispersed. This situation mandates not only the accessibility to remotely located production equipment for monitoring and control, but efficient means of responding to changing environment to counter process variations and diverse customer demands. To compete under such an environment, companies are striving to achieve 100%, sensor-based, automated inspection for zero-defect manufacturing. In this study, the Internet-based quality control scheme is referred to as "E-Quality for Manufacturing" or "EQM" for short. By its definition, EQM refers to a holistic approach to design and to embed efficient quality control functions in the context of network integrated manufacturing systems. Such system let designers located far away from the production facility to monitor, control and adjust the quality inspection processes as production design evolves.

Engineering of an inhalable DDA/TDB liposomal adjuvant: a quality-by-design approach towards optimization of the spray drying process.

PubMed

Ingvarsson, Pall Thor; Yang, Mingshi; Mulvad, Helle; Nielsen, Hanne Mørck; Rantanen, Jukka; Foged, Camilla

2013-11-01

The purpose of this study was to identify and optimize spray drying parameters of importance for the design of an inhalable powder formulation of a cationic liposomal adjuvant composed of dimethyldioctadecylammonium (DDA) bromide and trehalose-6,6'-dibehenate (TDB). A quality by design (QbD) approach was applied to identify and link critical process parameters (CPPs) of the spray drying process to critical quality attributes (CQAs) using risk assessment and design of experiments (DoE), followed by identification of an optimal operating space (OOS). A central composite face-centered design was carried out followed by multiple linear regression analysis. Four CQAs were identified; the mass median aerodynamic diameter (MMAD), the liposome stability (size) during processing, the moisture content and the yield. Five CPPs (drying airflow, feed flow rate, feedstock concentration, atomizing airflow and outlet temperature) were identified and tested in a systematic way. The MMAD and the yield were successfully modeled. For the liposome size stability, the ratio between the size after and before spray drying was modeled successfully. The model for the residual moisture content was poor, although, the moisture content was below 3% in the entire design space. Finally, the OOS was drafted from the constructed models for the spray drying of trehalose stabilized DDA/TDB liposomes. The QbD approach for the spray drying process should include a careful consideration of the quality target product profile. This approach implementing risk assessment and DoE was successfully applied to optimize the spray drying of an inhalable DDA/TDB liposomal adjuvant designed for pulmonary vaccination.

Standards Based Design: Teaching K-12 Educators to Build Quality Online Courses

ERIC Educational Resources Information Center

Quiroz, René E.; Ritter, Nicola L.; Li, Yun; Newton, Rhonda C.; Palkar, Trupti

2016-01-01

The number of online courses, programs, and schools are growing exponentially in K-12 education. Given the unique nature of online courses and the distinct skills necessary to create a quality online course, it is essential that effective professional development be provided for teachers designing online courses. Online courses need to be of the…

Incorporating Total Quality Management in an Engineering Design Course. Report 5-1993.

ERIC Educational Resources Information Center

Wilczynski, V.; And Others

One definition of creativity is the conviction that each and every existing idea can be improved. It is proposed that creativity in an engineering design process can be encouraged by the adoption of Total Quality Management (TQM) methods based on a commitment to continuous improvement. This paper addresses the introduction and application of TQM…

An Analysis of Departure Behaviors of High-Quality Career Designated First-Term Marine Officers

DTIC Science & Technology

2016-03-01

the Officer Retention Board (ORB) near the end of their first term. We show that TBS performance directly relates to officer performance over his/her...SUBJECT TERMS USMC, Marine Corps, Officer Retention Board, Meritorious Designation Program, The Basic School, Retention , officer quality, career...receive meritorious designation, while the remainder of the population competes on the Officer Retention Board (ORB) near the end of their first term. We

Predictive validity evidence for medical education research study quality instrument scores: quality of submissions to JGIM's Medical Education Special Issue.

PubMed

Reed, Darcy A; Beckman, Thomas J; Wright, Scott M; Levine, Rachel B; Kern, David E; Cook, David A

2008-07-01

Deficiencies in medical education research quality are widely acknowledged. Content, internal structure, and criterion validity evidence support the use of the Medical Education Research Study Quality Instrument (MERSQI) to measure education research quality, but predictive validity evidence has not been explored. To describe the quality of manuscripts submitted to the 2008 Journal of General Internal Medicine (JGIM) medical education issue and determine whether MERSQI scores predict editorial decisions. Cross-sectional study of original, quantitative research studies submitted for publication. Study quality measured by MERSQI scores (possible range 5-18). Of 131 submitted manuscripts, 100 met inclusion criteria. The mean (SD) total MERSQI score was 9.6 (2.6), range 5-15.5. Most studies used single-group cross-sectional (54%) or pre-post designs (32%), were conducted at one institution (78%), and reported satisfaction or opinion outcomes (56%). Few (36%) reported validity evidence for evaluation instruments. A one-point increase in MERSQI score was associated with editorial decisions to send manuscripts for peer review versus reject without review (OR 1.31, 95%CI 1.07-1.61, p = 0.009) and to invite revisions after review versus reject after review (OR 1.29, 95%CI 1.05-1.58, p = 0.02). MERSQI scores predicted final acceptance versus rejection (OR 1.32; 95% CI 1.10-1.58, p = 0.003). The mean total MERSQI score of accepted manuscripts was significantly higher than rejected manuscripts (10.7 [2.5] versus 9.0 [2.4], p = 0.003). MERSQI scores predicted editorial decisions and identified areas of methodological strengths and weaknesses in submitted manuscripts. Researchers, reviewers, and editors might use this instrument as a measure of methodological quality.

Designing train-speed trajectory with energy efficiency and service quality

NASA Astrophysics Data System (ADS)

Jia, Jiannan; Yang, Kai; Yang, Lixing; Gao, Yuan; Li, Shukai

2018-05-01

With the development of automatic train operations, optimal trajectory design is significant to the performance of train operations in railway transportation systems. Considering energy efficiency and service quality, this article formulates a bi-objective train-speed trajectory optimization model to minimize simultaneously the energy consumption and travel time in an inter-station section. This article is distinct from previous studies in that more sophisticated train driving strategies characterized by the acceleration/deceleration gear, the cruising speed, and the speed-shift site are specifically considered. For obtaining an optimal train-speed trajectory which has equal satisfactory degree on both objectives, a fuzzy linear programming approach is applied to reformulate the objectives. In addition, a genetic algorithm is developed to solve the proposed train-speed trajectory optimization problem. Finally, a series of numerical experiments based on a real-world instance of Beijing-Tianjin Intercity Railway are implemented to illustrate the practicability of the proposed model as well as the effectiveness of the solution methodology.

Study unique artistic lopburi province for design brass tea set of bantahkrayang community

NASA Astrophysics Data System (ADS)

Pliansiri, V.; Seviset, S.

2017-07-01

The objectives of this study were as follows: 1) to study the production process of handcrafted Brass Tea Set; and 2) to design and develop the handcrafted of Brass Tea Set. The process of design was started by mutual analytical processes and conceptual framework for product design, Quality Function Deployment, Theory of Inventive Problem Solving, Principles of Craft Design, and Principle of Reverse Engineering. The experts in field of both Industrial Product Design and Brass Handicraft Product, have evaluated the Brass Tea Set design and created prototype of Brass tea set by the sample of consumers who have ever bought the Brass Tea Set of Bantahkrayang Community on this research. The statistics methods used were percentage, mean ({{{\\overline X}} = }) and standard deviation (S.D.) 3. To assess consumer satisfaction toward of handcrafted Brass tea set was at the high level.

Application of advanced data collection and quality assurance methods in open prospective study - a case study of PONS project.

PubMed

Wawrzyniak, Zbigniew M; Paczesny, Daniel; Mańczuk, Marta; Zatoński, Witold A

2011-01-01

Large-scale epidemiologic studies can assess health indicators differentiating social groups and important health outcomes of the incidence and mortality of cancer, cardiovascular disease, and others, to establish a solid knowledgebase for the prevention management of premature morbidity and mortality causes. This study presents new advanced methods of data collection and data management systems with current data quality control and security to ensure high quality data assessment of health indicators in the large epidemiologic PONS study (The Polish-Norwegian Study). The material for experiment is the data management design of the large-scale population study in Poland (PONS) and the managed processes are applied into establishing a high quality and solid knowledge. The functional requirements of the PONS study data collection, supported by the advanced IT web-based methods, resulted in medical data of a high quality, data security, with quality data assessment, control process and evolution monitoring are fulfilled and shared by the IT system. Data from disparate and deployed sources of information are integrated into databases via software interfaces, and archived by a multi task secure server. The practical and implemented solution of modern advanced database technologies and remote software/hardware structure successfully supports the research of the big PONS study project. Development and implementation of follow-up control of the consistency and quality of data analysis and the processes of the PONS sub-databases have excellent measurement properties of data consistency of more than 99%. The project itself, by tailored hardware/software application, shows the positive impact of Quality Assurance (QA) on the quality of outcomes analysis results, effective data management within a shorter time. This efficiency ensures the quality of the epidemiological data and indicators of health by the elimination of common errors of research questionnaires and medical

Geohydrology of the Antelope Valley Area, California and design for a ground-water-quality monitoring network

USGS Publications Warehouse

Duell, L.F.

1987-01-01

A basinwide ideal network and an actual network were designed to identify ambient groundwater quality, trends in groundwater quality, and degree of threat from potential pollution sources in Antelope Valley, California. In general, throughout the valley groundwater quality has remained unchanged, and no specific trends are apparent. The main source of groundwater for the valley is generally suitable for domestic, irrigation, and most industrial uses. Water quality data for selected constituents of some network wells and surface-water sites are presented. The ideal network of 77 sites was selected on the basis of site-specific criteria, geohydrology, and current land use (agricultural, residential, and industrial). These sites were used as a guide in the design of the actual network consisting of 44 existing wells. Wells are currently being monitored and were selected whenever possible because of budgetary constraints. Of the remaining ideal sites, 20 have existing wells not part of a current water quality network, and 13 are locations where no wells exist. The methodology used for the selection of sites, constituents monitored, and frequency of analysis will enable network users to make appropriate future changes to the monitoring network. (USGS)

Initial Investigation of Reaction Control System Design on Spacecraft Handling Qualities for Earth Orbit Docking

NASA Technical Reports Server (NTRS)

Bailey, Randall E.; Jackson, E. Bruce; Goodrich, Kenneth H.; Ragsdale, W. Al; Neuhaus, Jason; Barnes, Jim

2008-01-01

A program of research, development, test, and evaluation is planned for the development of Spacecraft Handling Qualities guidelines. In this first experiment, the effects of Reaction Control System design characteristics and rotational control laws were evaluated during simulated proximity operations and docking. Also, the influence of piloting demands resulting from varying closure rates was assessed. The pilot-in-the-loop simulation results showed that significantly different spacecraft handling qualities result from the design of the Reaction Control System. In particular, cross-coupling between translational and rotational motions significantly affected handling qualities as reflected by Cooper-Harper pilot ratings and pilot workload, as reflected by Task-Load Index ratings. This influence is masked but only slightly by the rotational control system mode. While rotational control augmentation using Rate Command Attitude Hold can reduce the workload (principally, physical workload) created by cross-coupling, the handling qualities are not significantly improved. The attitude and rate deadbands of the RCAH introduced significant mental workload and control compensation to evaluate when deadband firings would occur, assess their impact on docking performance, and apply control inputs to mitigate that impact.

Data path design and image quality aspects of the next generation multifunctional printer

NASA Astrophysics Data System (ADS)

Brassé, M. H. H.; de Smet, S. P. R. C.

2008-01-01

Multifunctional devices (MFDs) are increasingly used as a document hub. The MFD is used as a copier, scanner, printer, and it facilitates digital document distribution and sharing. This imposes new requirements on the design of the data path and its image processing. Various design aspects need to be taken into account, including system performance, features, image quality, and cost price. A good balance is required in order to develop a competitive MFD. A modular datapath architecture is presented that supports all the envisaged use cases. Besides copying, colour scanning is becoming an important use case of a modern MFD. The copy-path use case is described and it is shown how colour scanning can also be supported with a minimal adaptation to the architecture. The key idea is to convert the scanner data to an opponent colour space representation at the beginning of the image processing pipeline. The sub-sampling of chromatic information allows for the saving of scarce hardware resources without significant perceptual loss of quality. In particular, we have shown that functional FPGA modules from the copy application can also be used for the scan-to-file application. This makes the presented approach very cost-effective while complying with market conform image quality standards.

Personal Goal Setting and Quality of Life: A Mixed Methods Study of Adult Professionals

ERIC Educational Resources Information Center

Ingraham, Frank

2017-01-01

This mixed methods study was designed to examine the potential impactful relationship between personal goal setting and the quality of life satisfaction (built upon the Goal Setting Theory of motivation and performance). The study aimed to determine how influential the goal achievement process is (or is not) regarding personal fulfillment and…

Designing occupancy studies: general advice and allocating survey effort

USGS Publications Warehouse

MacKenzie, D.I.; Royle, J. Andrew

2005-01-01

1. The fraction of sampling units in a landscape where a target species is present (occupancy) is an extensively used concept in ecology. Yet in many applications the species will not always be detected in a sampling unit even when present, resulting in biased estimates of occupancy. Given that sampling units are surveyed repeatedly within a relatively short timeframe, a number of similar methods have now been developed to provide unbiased occupancy estimates. However, practical guidance on the efficient design of occupancy studies has been lacking. 2. In this paper we comment on a number of general issues related to designing occupancy studies, including the need for clear objectives that are explicitly linked to science or management, selection of sampling units, timing of repeat surveys and allocation of survey effort. Advice on the number of repeat surveys per sampling unit is considered in terms of the variance of the occupancy estimator, for three possible study designs. 3. We recommend that sampling units should be surveyed a minimum of three times when detection probability is high (> 0.5 survey-1), unless a removal design is used. 4. We found that an optimal removal design will generally be the most efficient, but we suggest it may be less robust to assumption violations than a standard design. 5. Our results suggest that for a rare species it is more efficient to survey more sampling units less intensively, while for a common species fewer sampling units should be surveyed more intensively. 6. Synthesis and applications. Reliable inferences can only result from quality data. To make the best use of logistical resources, study objectives must be clearly defined; sampling units must be selected, and repeated surveys timed appropriately; and a sufficient number of repeated surveys must be conducted. Failure to do so may compromise the integrity of the study. The guidance given here on study design issues is particularly applicable to studies of species

A Study of Depression and Quality of Life in Patients of Lichen Planus

PubMed Central

Sawant, Neena S.; Vanjari, Nakul A.; Khopkar, Uday; Adulkar, Satish

2015-01-01

The precise cause of lichen planus is unknown, but the disease seems to be immunologically mediated. It is a psychocutaneous disorder. Due to scarcity of Indian studies in this field, we decided to study in patients of lichen planus the prevalence of depression and quality of life with comparison of the same in both the genders. Patients diagnosed as having lichen planus by consultant dermatologist were enrolled after informed consent and ethics approval. 45 patients were screened, of which 35 who satisfied the criteria were taken up for the study. A semistructured proforma was designed to collect the necessary information with administration of dermatology life quality index and Beck's depression inventory. While 25% were depressed with females being more affected than males, quality of life was impaired in more than 90% patients. Impairment was maximum due to symptoms and illness feelings, disturbed daily activities, or work and time consumption in treatment. There was a strong association between depression and impairment in quality of life in both the genders. This study helps in early identification of psychological problems in lichen planus patients and in planning their future course of management, hence reducing the lack of productivity and improving the prognosis and quality of life. PMID:25802892

Northern Great Plains Network water quality monitoring design for tributaries to the Missouri National Recreational River

USGS Publications Warehouse

Rowe, Barbara L.; Wilson, Stephen K.; Yager, Lisa; Wilson, Marcia H.

2013-01-01

The National Park Service (NPS) organized more than 270 parks with important natural resources into 32 ecoregional networks to conduct Inventory and Monitoring (I&M) activities for assessment of natural resources within park units. The Missouri National Recreational River (NRR) is among the 13 parks in the NPS Northern Great Plain Network (NGPN). Park managers and NGPN staff identified surface water resources as a high priority vital sign to monitor in park units. The objectives for the Missouri NRR water quality sampling design are to (1) assess the current status and long-term trends of select water quality parameters; and (2) document trends in streamflow at high-priority stream systems. Due to the large size of the Missouri River main stem, the NGPN water quality design for the Missouri NRR focuses on wadeable tributaries within the park unit. To correlate with the NGPN water quality protocols, monitoring of the Missouri NRR consists of measurement of field core parameters including dissolved oxygen, pH, specific conductance, and temperature; and streamflow. The purpose of this document is to discuss factors examined for selection of water quality monitoring on segments of the Missouri River tributaries within the Missouri NRR.Awareness of the complex history of the Missouri NRR aids in the current understanding and direction for designing a monitoring plan. Historical and current monitoring data from agencies and entities were examined to assess potential NGPN monitoring sites. In addition, the U.S. Environmental Protection Agency 303(d) list was examined for the impaired segments on tributaries to the Missouri River main stem. Because major tributaries integrate water quality effects from complex combinations of land use and environmental settings within contributing areas, a 20-mile buffer of the Missouri NRR was used to establish environmental settings that may impact the water quality of tributaries that feed the Missouri River main stem. For selection of

Quality by design: optimization of a freeze-drying cycle via design space in case of heterogeneous drying behavior and influence of the freezing protocol.

PubMed

Pisano, Roberto; Fissore, Davide; Barresi, Antonello A; Brayard, Philippe; Chouvenc, Pierre; Woinet, Bertrand

2013-02-01

This paper shows how to optimize the primary drying phase, for both product quality and drying time, of a parenteral formulation via design space. A non-steady state model, parameterized with experimentally determined heat and mass transfer coefficients, is used to define the design space when the heat transfer coefficient varies with the position of the vial in the array. The calculations recognize both equipment and product constraints, and also take into account model parameter uncertainty. Examples are given of cycles designed for the same formulation, but varying the freezing conditions and the freeze-dryer scale. These are then compared in terms of drying time. Furthermore, the impact of inter-vial variability on design space, and therefore on the optimized cycle, is addressed. With this regard, a simplified method is presented for the cycle design, which reduces the experimental effort required for the system qualification. The use of mathematical modeling is demonstrated to be very effective not only for cycle development, but also for solving problem of process transfer. This study showed that inter-vial variability remains significant when vials are loaded on plastic trays, and how inter-vial variability can be taken into account during process design.

Choosing a Cluster Sampling Design for Lot Quality Assurance Sampling Surveys