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1.
FASEB J ; 38(13): e23701, 2024 Jul 15.
Article in English | MEDLINE | ID: mdl-38941193

ABSTRACT

Zearalenone (ZEN) is a mycotoxin known for its estrogen-like effects, which can disrupt the normal physiological function of endometrial cells and potentially lead to abortion in female animals. However, the precise mechanism by which ZEN regulates endometrial function remains unclear. In this study, we found that the binding receptor estrogen receptors for ZEN is extensively expressed across various segments of the uterus and within endometrial cells, and a certain concentration of ZEN treatment reduced the proliferation capacity of goat endometrial epithelial cells (EECs) and endometrial stromal cells (ESCs). Meanwhile, cell cycle analysis revealed that ZEN treatment leaded to cell cycle arrest in goat EECs and ESCs. To explore the underlying mechanism, we investigated the mitochondrial quality control systems and observed that ZEN triggered excessive mitochondrial fission and disturbed the balance of mitochondrial fusion-fission dynamics, impaired mitochondrial biogenesis, increased mitochondrial unfolded protein response and mitophagy in goat EECs and ESCs. Additionally, ZEN treatment reduced the activities of mitochondrial respiratory chain complexes, heightened the production of hydrogen peroxide and reactive oxygen species, and caused cellular oxidative stress and mitochondrial dysfunction. These results suggest that ZEN has adverse effects on goat endometrium cells by disrupting the mitochondrial quality control system and affecting cell cycle and proliferation. Understanding the underlying molecular pathways involved in ZEN-induced mitochondrial dysfunction and its consequences on cell function will provide critical insights into the reproductive toxicity of ZEN and contribute to safeguarding the health and wellbeing of animals and humans exposed to this mycotoxin.


Subject(s)
Cell Proliferation , Endometrium , Goats , Mitochondria , Zearalenone , Animals , Female , Endometrium/cytology , Endometrium/metabolism , Endometrium/drug effects , Zearalenone/toxicity , Zearalenone/pharmacology , Mitochondria/metabolism , Mitochondria/drug effects , Cell Proliferation/drug effects , Reactive Oxygen Species/metabolism , Oxidative Stress/drug effects , Epithelial Cells/metabolism , Epithelial Cells/drug effects , Cells, Cultured , Mitochondrial Dynamics/drug effects , Mitophagy/drug effects , Stromal Cells/metabolism , Stromal Cells/drug effects , Stromal Cells/cytology
2.
Materials (Basel) ; 17(7)2024 Mar 22.
Article in English | MEDLINE | ID: mdl-38611974

ABSTRACT

Additive manufacturing (AM) also commonly known as 3D printing is an advanced technique for manufacturing complex three-dimensional (3D) parts by depositing raw material layer by layer. Various sub-categories of additive manufacturing exist including directed energy deposition (DED), powder bed fusion (PBF), and fused deposition modeling (FDM). FDM has gained widespread adoption as a popular method for manufacturing 3D parts, even for heavy-duty industrial applications. However, challenges remain, particularly regarding part quality. Print parameters such as print speed, nozzle temperature, and flow rate can significantly impact the final product's quality. To address this, implementing a closed-loop quality control system is essential. This system consistently monitors part surface quality during printing and adjusts print parameters upon defect detection. In this study, we propose a simple yet effective image analysis-based closed-loop control system, utilizing serial communication and Python v3.12, a widely accessible software platform. The system's accuracy and robustness are evaluated, demonstrating its effectiveness in ensuring FDM-printed part quality. Notably, this control system offers superior speed in restoring part quality to normal upon defect detection and is easily implementable on commercially available FDM 3D printers, fostering decentralized quality manufacturing.

3.
Technol Health Care ; 32(4): 2081-2090, 2024.
Article in English | MEDLINE | ID: mdl-38393932

ABSTRACT

OBJECTIVE: In order to improve nursing quality management and protect patient medical safety, it is necessary to change the default mode and completely integrate information technology and nursing quality control utilising lean management. METHODS: A database was created, the nurse quality control scoring standard was entered into the computer and after the inspection, and various inspection reports were entered into the computer to precisely and promptly preserve data. The computer was then utilised to precisely assess the intensity and quality of nursing work, compute, count, and analyse the stored data, output the quality of nursing work in each department as a report, and adopt lean management for the gathered issues. RESULTS: To reach the objective of raising nursing quality, data analysis makes it simple to identify flaws and consistently strengthen the weak points. In order to create an information-based nursing quality control system with a simple and effective method as well as results that are scientific and objective, lean management is brought into the construction process.


Subject(s)
Deep Learning , Quality Control , Humans , Total Quality Management
4.
CNS Neurosci Ther ; 30(2): e14576, 2024 02.
Article in English | MEDLINE | ID: mdl-38334212

ABSTRACT

BACKGROUND: Depression is the most disabling neuropsychiatric disorder, causing difficulties in daily life activities and social interactions. The exact mechanisms of depression remain largely unclear. However, some studies have shown that mitochondrial dysfunction would play a crucial role in the occurrence and development of depression. AIMS: To summarize the known knowledge about the role of mitochondrial dysfunction in the pathogenesis of depression. METHODS: We review the recent literature, including 105 articles, to summarize the mitochondrial energy metabolism and quality control systems in the occurrence and development of depression. Some antidepressants which may exert their effects by improving mitochondrial function are also discussed. RESULTS: Impaired brain energy metabolism and (or) damaged mitochondrial quality control systems have been reported not only in depression patients but in animal models of depression. Although the classical antidepressants have not been specially designed to target mitochondria, the evidence suggests that many antidepressants may exert their effects by improving mitochondrial function. CONCLUSIONS: This brief review focuses on the findings that implicate mitochondrial dysfunction and the quality control systems as important etiological factors in the context of depressive disorders. It will help us to understand the various concepts of mitochondrial dysfunction in the pathogenesis of depression, and to explore novel and more targeted therapeutic approaches for depression.


Subject(s)
Depression , Mitochondrial Diseases , Animals , Humans , Depression/drug therapy , Mitochondria/metabolism , Energy Metabolism , Antidepressive Agents/pharmacology , Antidepressive Agents/therapeutic use
5.
Brain Dev ; 45(5): 251-259, 2023 May.
Article in English | MEDLINE | ID: mdl-36870919

ABSTRACT

Chaperone therapy was introduced first as a new molecular therapeutic approach to lysosomal diseases. In a recent article, I reviewed the development of chaperone therapy mainly for lysosomal diseases. Then, more data have been collected particularly on non-lysosomal protein misfolding diseases. In this short review, I propose the concept of chaperone therapy to be classified into two different therapeutic approaches, for pH-dependent lysosomal, and pH-independent non-lysosomal protein misfolding diseases. The concept of lysosomal chaperone therapy is well established, but the non-lysosomal chaperone therapy is heterogeneous and to be investigated further for various individual diseases. As a whole, these two-types of new molecular therapeutic approaches will make an impact on the treatment of a wide range of pathological conditions caused by protein misfolding, not necessarily lysosomal but also many non-lysosomal diseases caused by gene mutations, metabolic diseases, malignancy, infectious diseases, and aging. The concept will open a completely new aspect of protein therapy in future.


Subject(s)
Molecular Chaperones , Proteostasis Deficiencies , Humans , Molecular Chaperones/metabolism , Proteostasis Deficiencies/genetics , Proteostasis Deficiencies/therapy , Proteostasis Deficiencies/metabolism , Mutation , Lysosomes/metabolism
7.
Cells ; 12(3)2023 01 21.
Article in English | MEDLINE | ID: mdl-36766738

ABSTRACT

This work investigated the effect of thyroxine on the biogenesis and quality control system in rat heart mitochondria. In hyperthyroid rats, the concentrations of free triiodothyronine and thyroxine increased severalfold, indicating the development of hyperthyroidism in these animals. The electron microscopy showed 58% of cardiac mitochondria to be in a swollen state. Some organelles were damaged and had a reduced number of cristae. Multilamellar bodies formed from cristae/membranes were found in the vacuolated part of the mitochondria. The hyperthyroidism caused no changes to mitochondrial biogenesis in the investigated animals. At the same time, the levels of mitochondrial dynamics proteins OPA1 and Drp1 increased in the hyperthyroid rats. The administration of thyroxine to the animals led to a decrease in the amount of PINK1 and Parkin in heart tissue. The data suggest that excess thyroid hormones lead to changes in mitochondrial dynamics and impair Parkin-dependent mitophagy in hyperthyroid rat heart.


Subject(s)
Hyperthyroidism , Mitophagy , Animals , Rats , Hyperthyroidism/metabolism , Mitochondria, Heart/metabolism , Mitochondrial Proteins/metabolism , Thyroxine/pharmacology , Ubiquitin-Protein Ligases/metabolism
8.
Int J Mol Sci ; 23(22)2022 Nov 18.
Article in English | MEDLINE | ID: mdl-36430802

ABSTRACT

This work investigated the effect of thyroxine on the biogenesis and quality control system of rat liver mitochondria. Chronic administration of thyroxine to experimental animals induced hyperthyroidism, which was confirmed by a severalfold increase in serum-free triiodothyronine and thyroxine concentrations. The uptake of oxygen was found to increase with a decrease in ADP phosphorylation efficiency and respiratory state ratio. Electron microscopy showed 36% of liver mitochondria to be swollen and approximately 18% to have a lysed matrix with a reduced number of cristae. Frequently encountered multilamellar bodies associated with defective mitochondria were located either at the edge of or inside the organelle. The number, area and perimeter of hyperthyroid rat mitochondria increased. Administration of thyroxine increased mitochondrial biogenesis and the quantity of mitochondrial DNA in liver tissue. Mitochondrial dynamics and mitophagy changed significantly. The data obtained indicate that excess thyroid hormones cause a disturbance of the mitochondrial quality control system and ultimately to the incorporation of potentially toxic material in the mitochondrial pool.


Subject(s)
Hyperthyroidism , Mitochondria, Liver , Rats , Animals , Mitochondria, Liver/metabolism , Mitophagy , Thyroxine/metabolism , Hyperthyroidism/metabolism , Triiodothyronine/metabolism
9.
J Thorac Dis ; 14(9): 3398-3407, 2022 Sep.
Article in English | MEDLINE | ID: mdl-36245604

ABSTRACT

Background: There are considerable differences in the diagnosis and treatment of pulmonary aspergillosis (PA) between specialized hospitals and primary hospitals or developed areas and underdeveloped areas in China. There is a lack of electronic systems that assist respiratory physicians in standardizing the diagnosis and treatment of PA. Methods: We extracted 26 quality control points from the latest guidelines related to PA, and developed a PA quality control system of electronic health record (EHR) based on natural language processing (NLP) techniques. We obtained PA patient records in the Department of Respiratory Medicine of the First Affiliated Hospital of Guangzhou Medical University to verify the effectiveness of the system comparing with manually evaluation of respiratory experts. Results: We successfully developed quality control system of PA; 699 PA medical records from EHR of the First Affiliated Hospital of Guangzhou Medical University between January 2015 and March 2020 were obtained and assessed by the system; 162 defects were found, which included 19 medical records with diagnostic defects, 76 medical records with examination defects, and 80 medical records with treatment defects; 200 medical records were sampled for validation, and found that the sensitivity and accuracy of quality control system for pulmonary aspergillosis (QCSA) were 0.99 and 0.96, F1 value was 0.85, and the recall rate was 0.77 compared with experts' evaluation. Conclusions: Our system successfully uses medical guidelines and NLP technology to detect defects in the diagnosis and treatment of PA, which helps to improve the management quality of PA patients.

10.
Front Endocrinol (Lausanne) ; 13: 934685, 2022.
Article in English | MEDLINE | ID: mdl-36093106

ABSTRACT

G protein-coupled receptors (GPCRs) are plasma membrane proteins associated with an array of functions. Mutations in these receptors lead to a number of genetic diseases, including diseases involving the endocrine system. A particular subset of loss-of-function mutant GPCRs are misfolded receptors unable to traffic to their site of function (i.e. the cell surface plasma membrane). Endocrine disorders in humans caused by GPCR misfolding include, among others, hypo- and hyper-gonadotropic hypogonadism, morbid obesity, familial hypocalciuric hypercalcemia and neonatal severe hyperparathyroidism, X-linked nephrogenic diabetes insipidus, congenital hypothyroidism, and familial glucocorticoid resistance. Several in vitro and in vivo experimental approaches have been employed to restore function of some misfolded GPCRs linked to endocrine disfunction. The most promising approach is by employing pharmacological chaperones or pharmacoperones, which assist abnormally and incompletely folded proteins to refold correctly and adopt a more stable configuration to pass the scrutiny of the cell's quality control system, thereby correcting misrouting. This review covers the most important aspects that regulate folding and traffic of newly synthesized proteins, as well as the experimental approaches targeted to overcome protein misfolding, with special focus on GPCRs involved in endocrine diseases.


Subject(s)
Endocrine System Diseases , Protein Folding , Cell Membrane/metabolism , Endocrine System Diseases/metabolism , Endocrine System Diseases/therapy , Humans , Infant, Newborn , Mutation , Receptors, G-Protein-Coupled/genetics , Receptors, G-Protein-Coupled/metabolism
11.
Front Plant Sci ; 13: 888978, 2022.
Article in English | MEDLINE | ID: mdl-35755658

ABSTRACT

Food traceability is very important for the quality and safety of agricultural products, which is related to the people's livelihood and national economy and has drawn great attention from governments and scientists around the world. The existing studies have not yet overcome the crisis characteristics comprehensively and systematically. A traceability system of red jujube is constructed by a hybrid mode of blockchain and the Internet of Things (IoTs). The system integrates the blockchain and the IoT technologies with characteristics of tamper-proof, decentralization, and distributed storage and solves the problem of date quality traceability by designing the technical process and architecture of date quality traceability and the big data of red jujube, jujube plantation, processing enterprise, commercial enterprises, and market administration. The whole process from planting to processing and sales of red jujube are recorded in the block to ensure the realization of quality traceability of red dates in the process. Through the whole process of big data processing, the key information collected in each process is stored in the database to ensure the realization of quality traceability of red dates in the framework. The system can help to minimize the production and distribution of unsafe or poor-quality products, thereby minimizing the potential for bad publicity, liability, and recalls.

12.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-932955

ABSTRACT

Objective:To explore the application and effect of multi-level quality control system (referred to as “quality control”) in health management center setting.Methods:The health management center of Hanzhong Central Hospital constructed a multi-level quality control system of “hospital-department-unit” and “department-unit-quality-controller” in August 2019. A total of 83 619 people who underwent physical examination in the Health Management Center of Hanzhong Central Hospital from August 2018 to July 2020 were selected as the subjects. 32 009 people who underwent physical examination from August 2018 to July 2019 were selected as the control group, and 51 610 people who underwent physical examination from August 2019 to July 2020 were selected as the experimental group. The timely notification of important abnormal results and the follow-up of the “four-high” population (hypertension, hyperglycemia, hyperlipidemia, and hyperuricemia) were observed. Two thousand satisfaction questionnaires and two thousand physical examination reports were collected from the institutions who had received both physical examination in the Health Management Center of Hanzhong Central Hospital for two consecutive years. The physical examination items of the above clients were basically the same. The satisfaction rate of the two groups of physical examination and the qualification rate of the physical examination reports were measured respectively.Results:The results showed that the timely notification rate of important abnormal results (99.4% vs 96.6%), follow-up rate of “four-high” population (hypertension 95.1% vs 91.2%, hyperglycemia 95.3% vs 91.6%, hyperlipidemia 94.6% vs 92.3%, hyperuricemia 92.7% vs 86.4%), satisfaction rate of physical examination (physical examination environment 94.0% vs 91.3%, service attitude 96.4% vs 91.9%, waiting time 97.6% vs 95.4%, physical examination process 98.3% vs 96.8%, professional level of medical staff 97.2% vs 95.1%), and qualified rate of physical examination report (accuracy of input information 99.5% vs 98.1%, accuracy of main examination conclusion 99.4% vs 97.3%, normative sorting 99.8% vs 98.8%, rationality of health advice 99.2% vs 96.8%) in the experimental group were significantly higher than those in the control group (all P<0.05). Conclusion:The establishment of a multi-level quality control system in health examination service can improve the timely notification rate of important abnormal results, the follow-up rate of the “four-high” population, the satisfaction of physical examinees, and the qualified rate of physical examination reports.

13.
Cardiology ; 146(6): 781-792, 2021.
Article in English | MEDLINE | ID: mdl-34547747

ABSTRACT

Coronary arterial disease is the most common cardiovascular disease. Myocardial ischemia-reperfusion injury caused by the initial interruption of organ blood flow and subsequent restoration of organ blood flow is an important clinical problem with various cardiac reperfusion strategies after acute myocardial infarction. Even though blood flow recovery is necessary for oxygen and nutrient supply, reperfusion causes pathological sequelae that lead to the aggravation of ischemic injury. At present, although it is known that injury will occur after reperfusion, clinical treatment always focuses on immediate recanalization. Mitochondrial fusion, fission, biogenesis, autophagy, and their intricate interaction constitute an effective mitochondrial quality control system. The mitochondrial quality control system plays an important role in maintaining cell homeostasis and cell survival. The removal of damaged, aging, and dysfunctional mitochondria is mediated by mitochondrial autophagy. With the help of appropriate changes in mitochondrial dynamics, new mitochondria are produced through mitochondrial biogenesis to meet the energy needs of cells. Mitochondrial dysfunction and the resulting oxidative stress have been associated with the pathogenesis of ischemia/reperfusion (I/R) injury, which play a crucial role in the pathophysiological process of myocardial injury. This review aimed at elucidating the mitochondrial quality control system and establishing the possibility of using mitochondria as a potential therapeutic target in the treatment of I/R injuries.


Subject(s)
Coronary Artery Disease , Myocardial Infarction , Myocardial Reperfusion Injury , Humans , Mitochondria
14.
Front Physiol ; 12: 629914, 2021.
Article in English | MEDLINE | ID: mdl-33716776

ABSTRACT

High-intensity interval training (HIIT) is reported to be beneficial to brain-derived neurotrophic factor (BDNF) biosynthesis. A key element in this may be the existence of lactate, the most obvious metabolic product of exercise. In vivo, this study investigated the effects of a 6-week HIIT on the peripheral and central lactate changes, mitochondrial quality control system, mitochondrial function and BDNF expression in mouse hippocampus. In vitro, primary cultured mice hippocampal cells were used to investigate the role and the underlying mechanisms of lactate in promoting mitochondrial function during HIIT. In vivo studies, we firstly reported that HIIT can potentiate mitochondrial function [boost some of the mitochondrial oxidative phosphorylation (OXPHOS) genes expression and ATP production], stimulate BDNF expression in mouse hippocampus along with regulating the mitochondrial quality control system in terms of promoting mitochondrial fusion and biogenesis, and suppressing mitochondrial fission. In parallel to this, the peripheral and central lactate levels elevated immediately after the training. In vitro study, our results revealed that lactate was in charge of regulating mitochondrial quality control system for mitochondrial function and thus may contribute to BDNF expression. In conclusion, our study provided the mitochondrial mechanisms of HIIT enhancing brain function, and that lactate itself can mediate the HIIT effect on mitochondrial quality control system in the hippocampus.

15.
Front Immunol ; 11: 601740, 2020.
Article in English | MEDLINE | ID: mdl-33304353

ABSTRACT

Sterile inflammation develops as part of an innate immunity response to molecules released upon tissue injury and collectively indicated as damage-associated molecular patterns (DAMPs). While coordinating the clearance of potential harmful stimuli, promotion of tissue repair, and restoration of tissue homeostasis, a hyper-activation of such an inflammatory response may be detrimental. The complex regulatory pathways modulating DAMPs generation and trafficking are actively investigated for their potential to provide relevant insights into physiological and pathological conditions. Abnormal circulating extracellular vesicles (EVs) stemming from altered endosomal-lysosomal system have also been reported in several age-related conditions, including cancer and neurodegeneration, and indicated as a promising route for therapeutic purposes. Along this pathway, mitochondria may dispose altered components to preserve organelle homeostasis. However, whether a common thread exists between DAMPs and EVs generation is yet to be clarified. A deeper understanding of the highly complex, dynamic, and variable intracellular and extracellular trafficking of DAMPs and EVs, including those of mitochondrial origin, is needed to unveil relevant pathogenic pathways and novel targets for drug development. Herein, we describe the mechanisms of generation of EVs and mitochondrial-derived vesicles along the endocytic pathway and discuss the involvement of the endosomal-lysosomal in cancer and neurodegeneration (i.e., Alzheimer's and Parkinson's disease).


Subject(s)
Alarmins/metabolism , Extracellular Vesicles/metabolism , Immunity, Innate , Inflammation/metabolism , Animals , Endosomes/immunology , Endosomes/metabolism , Extracellular Vesicles/immunology , Extracellular Vesicles/pathology , Humans , Inflammation/immunology , Inflammation/pathology , Lysosomes/immunology , Lysosomes/metabolism , Mitochondria/immunology , Mitochondria/metabolism , Protein Transport , Signal Transduction
16.
Hepatol Int ; 14(4): 437-453, 2020 Jul.
Article in English | MEDLINE | ID: mdl-32638296

ABSTRACT

Three-dimensional (3D) visualization involves feature extraction and 3D reconstruction of CT images using a computer processing technology. It is a tool for displaying, describing, and interpreting 3D anatomy and morphological features of organs, thus providing intuitive, stereoscopic, and accurate methods for clinical decision-making. It has played an increasingly significant role in the diagnosis and management of liver diseases. Over the last decade, it has been proven safe and effective to use 3D simulation software for pre-hepatectomy assessment, virtual hepatectomy, and measurement of liver volumes in blood flow areas of the portal vein; meanwhile, the use of 3D models in combination with hydrodynamic analysis has become a novel non-invasive method for diagnosis and detection of portal hypertension. We herein describe the progress of research on 3D visualization, its workflow, current situation, challenges, opportunities, and its capacity to improve clinical decision-making, emphasizing its utility for patients with liver diseases. Current advances in modern imaging technologies have promised a further increase in diagnostic efficacy of liver diseases. For example, complex internal anatomy of the liver and detailed morphological features of liver lesions can be reflected from CT-based 3D models. A meta-analysis reported that the application of 3D visualization technology in the diagnosis and management of primary hepatocellular carcinoma has significant or extremely significant differences over the control group in terms of intraoperative blood loss, postoperative complications, recovery of postoperative liver function, operation time, hospitalization time, and tumor recurrence on short-term follow-up. However, the acquisition of high-quality CT images and the use of these images for 3D visualization processing lack a unified standard, quality control system, and homogeneity, which might hinder the evaluation of application efficacy in different clinical centers, causing enormous inconvenience to clinical practice and scientific research. Therefore, rigorous operating guidelines and quality control systems need to be established for 3D visualization of liver to develop it to become a mature technology. Herein, we provide recommendations for the research on diagnosis and management of 3D visualization in liver diseases to meet this urgent need in this research field.


Subject(s)
Imaging, Three-Dimensional , Liver Diseases/diagnostic imaging , Tomography, X-Ray Computed , Humans , Liver Diseases/surgery
17.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(1): 85-87, 2020 Jan 08.
Article in Chinese | MEDLINE | ID: mdl-32343075

ABSTRACT

The construction of county and district medical community is an important measure for high-quality medical resources to "double sink and improve". In this study, we have initially constructed a medical equipment quality control system for members of the regional medical community. The current situation of lack of professional medical equipment management personnel and quality control equipment in primary medical institutions has been alleviated, the quality control level of medical equipment in primary medical institutions has been improved, and a new management model for quality control of primary medical equipment has been explored.


Subject(s)
Equipment and Supplies, Hospital/standards , Materials Management, Hospital/organization & administration , Quality Control
18.
Bioanalysis ; 12(5): 319-333, 2020 Mar.
Article in English | MEDLINE | ID: mdl-32129082

ABSTRACT

Aim: Clinical research in pediatrics is progressively initiated by academia. As the reliability of pharmacodynamic measures is closely linked to the quality of bioanalytical data, bioanalytical quality assurance is crucial. However, clear guidance on comprehensive bioanalytical quality monitoring in the academic environment is lacking. Methods & results: By applying regulatory guidelines, international recommendations and scientific discussions, a five-step quality control system for monitoring the bioanalysis of aldosterone by immunoassay was developed. It comprised performance qualification, calibration curve evaluation, analysis of the intra- and inter-run performance via quality control samples, incurred sample reanalysis and external quality assessment by interlaboratory testing. A total of 55 out of 70 runs were qualified for the quantification of aldosterone in the study sample enabling the evaluation of 954 pediatric samples and demonstrating reliability over the 29-month bioanalysis period. Conclusion: The bioanalytical quality control system successfully monitored the aldosterone assay performance and proved its applicability in the academic environment.


Subject(s)
Quality Control , Adolescent , Child , Child, Preschool , Female , Humans , Male , Pediatrics , Research Design
19.
J Pharm Biomed Anal ; 181: 113090, 2020 Mar 20.
Article in English | MEDLINE | ID: mdl-31915108

ABSTRACT

While the role of plasma renin activity (PRA) in heart failure has been widely studied in adults, comprehensive data on pediatric heart failure remain lacking. This drawback is increasingly being addressed by academic research. Nevertheless, such pediatric investigations are commonly conducted only once due to ethical constraints. Therefore, the quality of bioanalytical data must be ensured to acquire meaningful insights into maturing humoral parameters. However, appropriate post-validation assessment of bioanalytical runs is currently underrepresented by regulatory guidance. Thus, for applications in an academic environment, an easy-to-handle six-step bioanalytical quality control system was designed based on regulatory guidelines (e.g. U.S. Food and Drug Administration) combined with international recommendations (e.g. Clinical and Laboratory Standards Institute) and current scientific discussion. Its applicability to an enzyme-linked immunosorbent assay for determination of PRA was investigated within three pediatric trials of the EU-funded "Labeling of Enalapril in Neonates up to Adolescents" project. This quality control system identified 15 % bioanalytical runs as non-compliant to the predefined specifications and ensured the reliable quantification of 940 pharmacodynamic samples. The inter-run assessment of quality controls was able to demonstrate the comparability of the study results. Furthermore, 86 % of incurred sample reanalysis pairs complied with regulatory requirements (>67 %), thus underlining the long-term reproducibility of the utilized ligand-binding assay. Successful participation in interlaboratory testing confirmed the accuracy of the applied method throughout the entire study period. Further investigations showed no notable differences between the five applied lots of the PRA assay. The applicability of this quality control system was proven in an academic environment and ensured reliable results for PRA over the entire 24-month study period.


Subject(s)
Angiotensin-Converting Enzyme Inhibitors/pharmacology , Drug Monitoring/methods , Enalapril/pharmacology , Heart Failure/diagnosis , Renin/metabolism , Adolescent , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Child , Child, Preschool , Drug Monitoring/standards , Enalapril/therapeutic use , Enzyme-Linked Immunosorbent Assay/standards , Female , Heart Failure/blood , Heart Failure/drug therapy , Heart Failure/physiopathology , Humans , Infant , Male , Prognosis , Proof of Concept Study , Quality Control , Renin/blood , Renin/isolation & purification , Renin-Angiotensin System/physiology , Reproducibility of Results
20.
Technol Health Care ; 28(2): 155-163, 2020.
Article in English | MEDLINE | ID: mdl-31282444

ABSTRACT

BACKGROUND: Quality control system is one of the hospital information systems. The adoption of quality control system increases the work efficiency; however, to some extent, it also increases the workload for physicians. OBJECTIVE: The purpose of this study is to investigate the impacts of the quality control system on quality of care (e.g., process and outcome performance). METHODS: Our study collected physicians' behavior information from a large urban hospital in China. We constructed the fixed-effect model to examine the relationship between the quality control system adoption and quality of care. RESULTS: Using the quality control system has a significant (p< 0.001) and negative effect on patients' stay length in the hospital (process performance). Furthermore, using the quality control system has a significant (p< 0.001) and positive effect on the trends of cure rate in the hospital (outcome performance). The coefficient of the dependent variable from the patients' stay length (process performance) is lower than the trends of cure rate (outcome performance). CONCLUSIONS: The controlling system can improve medical quality even though it limits physician behavior to some extent. The controlling system improves both the process performance and outcome performance, and it brings more benefits to outcome performance rather than process performance which means the reflection of the new technology may have more evident on outcome variables.


Subject(s)
Hospital Administration/standards , Outcome Assessment, Health Care/organization & administration , Practice Patterns, Physicians'/organization & administration , Quality Control , Quality of Health Care/organization & administration , China , Humans , Practice Patterns, Physicians'/standards , Quality Indicators, Health Care , Quality of Health Care/standards
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