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result(s) for
"quality assurance protocols"
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Advancing herbal medicine: enhancing product quality and safety through robust quality control practices
2023
This manuscript provides an in-depth review of the significance of quality control in herbal medication products, focusing on its role in maintaining efficiency and safety. With a historical foundation in traditional medicine systems, herbal remedies have gained widespread popularity as natural alternatives to conventional treatments. However, the increasing demand for these products necessitates stringent quality control measures to ensure consistency and safety. This comprehensive review explores the importance of quality control methods in monitoring various aspects of herbal product development, manufacturing, and distribution. Emphasizing the need for standardized processes, the manuscript delves into the detection and prevention of contaminants, the authentication of herbal ingredients, and the adherence to regulatory standards. Additionally, it highlights the integration of traditional knowledge and modern scientific approaches in achieving optimal quality control outcomes. By emphasizing the role of quality control in herbal medicine, this manuscript contributes to promoting consumer trust, safeguarding public health, and fostering the responsible use of herbal medication products.
Journal Article
National protocol for quality assurance in DXA-bone densitometry
by
Vassileva, J.
,
Slavchev, A.
,
Avramova-Cholakova, S.
in
DXA bone densitometry
,
QC measurements
,
quality assurance protocol
2008
Osteoporosis becomes largely one of the most important socially significant and costly diseases. Modern techniques (DXA, US) are applied for bone densitometry. The paper presents a protocol for quality assurance especially of DXA-bone densitometers including quality control made in compliance with international standards (ISCD, IOF). The methodology has been tested in practice by measurements on site-functional assessment, entrance dose, radiation protection, calibration, in-vitro precision. It is expected to raise the quality of the diagnostic process in concert with the EU Medical Directive 97/43 particularly for population screening and sensitive groups. The protocol is an essential part of the National Program for constraining osteoporosis which has been elaborated at the Ministry of Health and at present under implementation throughout the country. It aims at reducing the risk, factors spreading, at diminishing the fracture risk the morbidity and the mortality from osteoporosis. An integral multidisciplinary approach to the problem solving is applied as well as training on three levels — doctors, patients, population, which effectively will contribute for obtaining real results in preventing osteoporosis.
Journal Article
Comparison of Traditional and Novel Drying Techniques and Its Effect on Quality of Fruits, Vegetables and Aromatic Herbs
by
Figiel, Adam
,
Cano-Lamadrid, Marina
,
Calín-Sánchez, Ángel
in
antioxidant activity
,
Antioxidants
,
behavior
2020
Drying is known as the best method to preserve fruits, vegetables, and herbs, decreasing not only the raw material volume but also its weight. This results in cheaper transportation and increments the product shelf life, limiting the food waste. Drying involves the application of energy in order to vaporize and mobilize the moisture content within the porous products. During this process, the heat and mass transfer occurs simultaneously. The quality of dehydrated fruits, vegetables, and aromatic herbs is a key problem closely related to the development and optimization of novel drying techniques. This review reports the weaknesses of common drying methods applied for fruits, vegetables, and aromatic herbs and the possible options to improve the quality of dried products using different drying techniques or their combination. The quality parameters under study include color, bulk density, porosity, shrinkage, phytochemicals, antioxidant capacity, sugars, proteins, volatile compounds, and sensory attributes. In general, drying leads to reduction in all studied parameters. However, the behavior of each plant material is different. On the whole, the optimal drying technique is different for each of the materials studied and specific conditions must be recommended after a proper evaluation of the drying protocols. However, a novel or combined technique must assure a high quality of dried products. Furthermore, the term quality must englobe the energy efficiency and the environmental impact leading to production of sustainable dried products.
Journal Article
Clinical development of new drug–radiotherapy combinations
by
Harrington, Kevin J.
,
Kelly, Stephen
,
Hawkins, Maria A.
in
631/154/1438
,
692/308/2779/109
,
692/4028/67/1059/485
2016
The National Cancer Research Institute Clinical and Translational Radiotherapy Research Working Group (CTRad) includes academia, industry, patient groups and regulatory bodies representatives. In this Consensus Statement, recommendations are provided with the aim of increasing the number of novel drugs being successfully registered in combination with radiotherapy in clinical trials for patients with cancer.
In countries with the best cancer outcomes, approximately 60% of patients receive radiotherapy as part of their treatment, which is one of the most cost-effective cancer treatments. Notably, around 40% of cancer cures include the use of radiotherapy, either as a single modality or combined with other treatments. Radiotherapy can provide enormous benefit to patients with cancer. In the past decade, significant technical advances, such as image-guided radiotherapy, intensity-modulated radiotherapy, stereotactic radiotherapy, and proton therapy enable higher doses of radiotherapy to be delivered to the tumour with significantly lower doses to normal surrounding tissues. However, apart from the combination of traditional cytotoxic chemotherapy with radiotherapy, little progress has been made in identifying and defining optimal targeted therapy and radiotherapy combinations to improve the efficacy of cancer treatment. The National Cancer Research Institute Clinical and Translational Radiotherapy Research Working Group (CTRad) formed a Joint Working Group with representatives from academia, industry, patient groups and regulatory bodies to address this lack of progress and to publish recommendations for future clinical research. Herein, we highlight the Working Group's consensus recommendations to increase the number of novel drugs being successfully registered in combination with radiotherapy to improve clinical outcomes for patients with cancer.
Journal Article
Redesigning systems to improve teamwork and quality for hospitalized patients (RESET): study protocol evaluating the effect of mentored implementation to redesign clinical microsystems
2019
Background
A number of challenges impede our ability to consistently provide high quality care to patients hospitalized with medical conditions. Teams are large, team membership continually evolves, and physicians are often spread across multiple units and floors. Moreover, patients and family members are generally poorly informed and lack opportunities to partner in decision making. Prior studies have tested interventions to redesign aspects of the care delivery system for hospitalized medical patients, but the majority have evaluated the effect of a single intervention. We believe these interventions represent complementary and mutually reinforcing components of a redesigned clinical microsystem. Our specific objective for this study is to implement a set of evidence-based complementary interventions across a range of clinical microsystems, identify factors and strategies associated with successful implementation, and evaluate the impact on quality.
Methods
The RESET project uses the Advanced and Integrated MicroSystems (AIMS) interventions. The AIMS interventions consist of 1) Unit-based Physician Teams, 2) Unit Nurse-Physician Co-leadership, 3) Enhanced Interprofessional Rounds, 4) Unit-level Performance Reports, and 5) Patient Engagement Activities. Four hospital sites were chosen to receive guidance and resources as they implement the AIMS interventions. Each study site has assembled a local leadership team, consisting of a physician and nurse, and receives mentorship from a physician and nurse with experience in leading similar interventions. Primary outcomes include teamwork climate, assessed using the Safety Attitudes Questionnaire, and adverse events using the Medicare Patient Safety Monitoring System (MPSMS). RESET uses a parallel group study design and two group pretest-posttest analyses for primary outcomes. We use a multi-method approach to collect and triangulate qualitative data collected during 3 visits to study sites. We will use cross-case comparisons to consider how site-specific contextual factors interact with the variation in the intensity and fidelity of implementation to affect teamwork and patient outcomes.
Discussion
The RESET study provides mentorship and resources to assist hospitals as they implement complementary and mutually reinforcing components to redesign the clinical microsystems caring for medical patients. Our findings will be of interest and directly applicable to all hospitals providing care to patients with medical conditions.
Trial registration
NCT03745677
. Retrospectively registered on November 19, 2018.
Journal Article
Procedures for large-scale metabolic profiling of serum and plasma using gas chromatography and liquid chromatography coupled to mass spectrometry
by
Zelena, Eva
,
Begley, Paul
,
Francis-McIntyre, Sue
in
631/1647/2230/1378
,
631/1647/320
,
631/1647/527/296
2011
Metabolism has an essential role in biological systems. Identification and quantitation of the compounds in the metabolome is defined as metabolic profiling, and it is applied to define metabolic changes related to genetic differences, environmental influences and disease or drug perturbations. Chromatography–mass spectrometry (MS) platforms are frequently used to provide the sensitive and reproducible detection of hundreds to thousands of metabolites in a single biofluid or tissue sample. Here we describe the experimental workflow for long-term and large-scale metabolomic studies involving thousands of human samples with data acquired for multiple analytical batches over many months and years. Protocols for serum- and plasma-based metabolic profiling applying gas chromatography–MS (GC-MS) and ultraperformance liquid chromatography–MS (UPLC-MS) are described. These include biofluid collection, sample preparation, data acquisition, data pre-processing and quality assurance. Methods for quality control–based robust LOESS signal correction to provide signal correction and integration of data from multiple analytical batches are also described.
Journal Article
Mathematical Modeling and Validation of Retransmission-Based Mutant MQTT for Improving Quality of Service in Developing Smart Cities
by
Hewage, Chaminda
,
Asif, Rameez
,
Zafar, Mohammad Haseeb
in
Analysis
,
Bandwidths
,
Building automation
2022
Unreliable networks often use excess bandwidth for data integration in smart cities. For this purpose, Messaging Queuing Telemetry Transport (MQTT) with a certain quality of service (QoS) is employed. Data integrity and data security are frequently compromised for reducing bandwidth usage while designing integrated applications. Thus, for a reliable and secure integrated Internet of Everything (IoE) service, a range of network parameters are conditioned to achieve the required quality of a deliverable service. In this work, a QoS-0-based MQTT is developed in such a manner that the transparent MQTT protocol uses Transmission Control Protocol (TCP)-based connectivity with various rules for the retransmission of contents if the requests are not entertained for a fixed duration. The work explores the ways to improve the overall content delivery probability. The parameters are examined over a transparent gateway-based TCP network after developing a mathematical model for the proposed retransmission-based mutant QoS-0. The probability model is then verified by an actual physical network where the repeated content delivery is explored at VM-based MQTT, local network-based broker and a remote server. The results show that the repeated transmission of contents from the sender improves the content delivery probability over the unreliable MQTT-based Internet of Things (IoT) for developing smart cities’ applications.
Journal Article
Feasibility of MR-Based Body Composition Analysis in Large Scale Population Studies
by
Bell, Jimmy D.
,
Borga, Magnus
,
Thomas, Louise
in
Abdomen
,
Acceptance criteria
,
Adipose tissue
2016
Quantitative and accurate measurements of fat and muscle in the body are important for prevention and diagnosis of diseases related to obesity and muscle degeneration. Manually segmenting muscle and fat compartments in MR body-images is laborious and time-consuming, hindering implementation in large cohorts. In the present study, the feasibility and success-rate of a Dixon-based MR scan followed by an intensity-normalised, non-rigid, multi-atlas based segmentation was investigated in a cohort of 3,000 subjects.
3,000 participants in the in-depth phenotyping arm of the UK Biobank imaging study underwent a comprehensive MR examination. All subjects were scanned using a 1.5 T MR-scanner with the dual-echo Dixon Vibe protocol, covering neck to knees. Subjects were scanned with six slabs in supine position, without localizer. Automated body composition analysis was performed using the AMRA Profiler™ system, to segment and quantify visceral adipose tissue (VAT), abdominal subcutaneous adipose tissue (ASAT) and thigh muscles. Technical quality assurance was performed and a standard set of acceptance/rejection criteria was established. Descriptive statistics were calculated for all volume measurements and quality assurance metrics.
Of the 3,000 subjects, 2,995 (99.83%) were analysable for body fat, 2,828 (94.27%) were analysable when body fat and one thigh was included, and 2,775 (92.50%) were fully analysable for body fat and both thigh muscles. Reasons for not being able to analyse datasets were mainly due to missing slabs in the acquisition, or patient positioned so that large parts of the volume was outside of the field-of-view.
In conclusion, this study showed that the rapid UK Biobank MR-protocol was well tolerated by most subjects and sufficiently robust to achieve very high success-rate for body composition analysis. This research has been conducted using the UK Biobank Resource.
Journal Article
Sepsis 3 from the perspective of clinicians and quality improvement initiatives
by
AbDulaziz, Salman
,
Daniels, Ron
,
Lander, Harvey
in
Blood pressure
,
Clinical Protocols
,
Consensus
2017
The publication of the Sepsis-3 definitions resulted in a number of concerns related to its impact on the work of QI initiatives that focus on early identification and treatment of sepsis and prompted statements by the GSA, HYPERLINK “http://www.global-sepsis-alliance.org“www.global-sepsis-alliance.org and the Surviving Sepsis campaign (SSC), www.survivingsepsis.org. [...]in this document we aim to assess the new sepsis definitions [1] in the context of quality improvement initiatives. The current proposition adds burden to the data collection as well as for the bedside healthcare workers, since the complexity of calculating variations in six different organ dysfunction systems is high. [...]having SOFA variation as a definition also reduces its usefulness in the measurement burden, one of the relevant domains used to define usefulness of disease definitions. The broad definition of sepsis, the presence of a life threating organ dysfunction, should remain the basis of all QI initiatives. [...]screening for early identification and treatment of patients with sepsis (formerly called severe sepsis) should continue essentially as previously recommended by SSC and seek the presence of any organ dysfunction. [...]their statements were not sufficient to clarify how the new definitions can be used at bedside. [...]our proposal is that an additional statement by the Sepsis 3 authors be issued in order to clarify some of these points as stated below.
Journal Article
Quality assurance for polychromatic flow cytometry using a suite of calibration beads
by
Ambrozak, David
,
Chattopadhyay, Pratip K
,
Nguyen, Richard
in
13/31
,
631/1647/1407/1492
,
Analytical Chemistry
2012
The quality assurance program presented here provides a means to maximize and maintain the performance of individual flow cytometers in a facility. To optimize performance, we recommend performing all three steps (optimization, calibration and standardization) in this program when a new flow cytometer is installed or whenever the flow cytometer's optical path is altered (e.g., lasers, filters or detectors are replaced). The complete process requires 3–4 h. On a more frequent basis, only a subset of these procedures need to be performed as a part of daily maintenance routines. The data generated can be tracked to monitor the instrument and determine whether service is needed. In addition, the data can provide a metric for whether repairs and upgrades have improved or harmed performance, and for future instrument-to-instrument comparisons. In sum, the procedures presented here represent an updated framework for optimizing, calibrating and standardizing a flow cytometer for daily use.
Journal Article