Quality Control Standards Research Articles

Abstract 5229: Pathogenic germline mutations and risk of multiple myeloma

Abstract BACKGROUND: Multiple Myeloma (MM) is an incurable disease with no known germline high penetrant risk gene. The higher risk of MM among affected relatives suggests a genetic contribution to the etiology. To date, 24 common risk variants with low effect sizes were identified using genome-wide association studies, which account for 17% of heritability. However, a systematic analysis of the known rare alleles in cancer predisposition genes has not been undertaken so far in MM. We collaborated with six other academic centers across the United States to identify and select cases for analysis of germline predisposition of MM. METHODS: We performed whole exome, next-generation sequencing of 2,387 familial or early onset germline MM cases from the myeloma sequencing consortium (MMSEQ). We called 1.5 million variants and performed standard quality control of the data. We also obtained exome data on 1,285 cases from UK Biobank (UKBB) and 344,513 non-cancer controls (total=3,672 cases). We analyzed the ultra-rare, coding variants in 90 clinically relevant or putative candidates for cancer predisposition. We then used the automated variant curator PathoMAN to annotate and assert pathogenicity of each variant. We contrasted our results with assertions of pathogenicity from ClinVar and tested for gene association with MM. RESULTS: Overall, we observed several pathogenic or likely pathogenic variants, both singleton and recurrent founder mutations. In the MMSEQ, 8.7% of MM cases harbored a pathogenic variant in these known/putative cancer predisposition genes. Predominant group of pathogenic variants were observed within CHEK2 (19%), TP53 (8%), and ATM (5%). A case-control analysis revealed strong association with TP53 and weakly with ATM. In the familial/early onset MMSEQ cases, TP53 mutations were enriched 68 times more than in the UKBB controls. Our preliminary results suggest that known genes of cancer susceptibility such as TP53 and ATM may also play a role in myeloma risk. CONCLUSION: In a large study of multi-center MM cases, we identified a significant proportion of individuals who are carriers of known (solid) cancer predisposition genes. This study suggests that these known cancer predisposition genes may be relevant in a subset of MM cases. Citation Format: Michael T. Conry, Nicola Camp, Celine Vachon, Michelle Hildebrandt, Elizabeth E. Brown, Steven M. Lipkin, Judy Garber, Susan L. Slager, Samantha Stokes, Aaron D. Norman, Aalin Izhar, Sita Dandiker, Kylee Maclachlan, Kenneth Offit, Saad Usmani, Vijai Joseph. Pathogenic germline mutations and risk of multiple myeloma. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5229.

Quality Management of Distance Learning Higher Education

This article aims to describe the implementation of distance learning necessitates a quality management system for higher education. The method is qualitative, which can be explained by the reality of quality management in distance learning higher education. Literature related to quality management of distance learning in higher education, including problems and constraints of distance learning, management models in distance learning, distance learning systems approaches, roles in distance learning, online learning design components, and long-distance higher education quality assurance systems, serves as a data source. The results of the discussion can indicate actions for maintaining quality levels, such as (a) quality management, management so that there is still quality control for graduates who are expected to meet nationally accepted competency standards (quality control), and (b) higher education with distance learning is able to respond to any situation. Changes in learning include the development of distance education, and (c) distance education is the development of the concept of a cyber university or what is commonly known as distance learning in Indonesia.

The Effect Of The Implementation Of Quality Control Standards (SPM) On Audit Quality At Public Accounting Firm (KAP) In Malang

The existence of a Quality Control System (SPM) is absolutely necessary for Public Accounting Firms (KAP) in an effort to maintain and control audit quality. There are nine components of Quality Control Standards (SPM) listed in SPAP (2011) SPM section 100 No. 07, including independence, personal assignment, consultation, supervision, hiring, professional growth, promotion, customer acceptance, continuity, and inspection. The goal of this study was to ascertain the impact of implementing the QCS (SPM) elements on audit quality at KAP Public Accounting Firms in Malang City. 13 Public Accounting Companies (KAP) in Malang City that are members of the Indonesian Institute of Certified Public Accountants make up the study's sample (IAPI). Techniques for gathering data include convenience sampling or interviewing people in the population who are receptive to answering questions. The researcher gave 10 questionnaires for each Public Accounting Firm (KAP) in Malang City. Using multiple linear regression analysis, the T-test, the F-test, the validity test, the reliability test, and the classical assumption test when processing data. The study's findings indicate that audit quality is influenced in part by independence, personal assignment, consultation, supervision, advancement, and inspection. Meanwhile, audit quality is not much impacted by employment, professional growth, client acceptance, or sustainability. Independence, freelancing, personal projects, consultancy, oversight, hiring, and career advancement.

The Evaluation of Quality Control and Laboratory Management in Microbiology Laboratories in Sudan Comparing to the International Standards

Background: The microbiology laboratory plays an important role in isolation, characteristic of microorganisms, clinical function {infection control}, epidemiological, surveillance, prevention, finding the route of transmission of infective microbe, and participate in the antimicrobial stewardship programs (1). Hence the basic rights of laboratory test reports are the reliability, accuracy, timeliness, and in form that can be sense (2), so, the quality management system model is remarkable to attaining excellence in laboratories practices and improving quality (3). Objectives: The main objective of this study was to evaluate the quality control and laboratory management of microbiology laboratories in Sudan comparing to the international standards. Materials and Methods: The type of this study is non interventional study, observational research method, cross sectional study was carried out between 2014 to 2023 structured questionnaire distributed to the seven microbiology laboratories in Khartoum state and Aljazeera state in Sudan to evaluate the quality control and the laboratory management checking and assessing the facility setup, personnel, laboratory facilities, environment and biosafety, equipment, quality system, identification methods, Antibiotic susceptibility testing methods of these microbiology laboratories. SPSS statistical system and Microsoft excel were utilized for data analysis. Results: The results proposed in Tables and demonstrated that most of the questionnaires respondents about the procedures for the tests and methods done in the laboratory standardized in accordance with the ISO 15189:2012 their number was 81 with percentage (64.3%) there were 45with percentage (35.7%) was not complying the standards.Conclusion: The study revealed that all these microbiology laboratories have moderate performance quality control and laboratory management standards and their needs to continuous improvement programs to provide better patient care.

Integration of multiomics with precision nutrition for gestational diabetes: Study protocol for the Westlake Precision Birth Cohort

Integration of multiomics with precision nutrition for gestational diabetes: Study protocol for the Westlake Precision Birth Cohort

Metabolomics-Based Analysis of the Effects of Different Cultivation Strategies on Metabolites of Dendrobium officinale Kimura et Migo.

Dendrobium officinale Kimura et Migo is a famous plant with a high medicinal value which has been recorded in the Chinese Pharmacopoeia (2020 Edition). The medicinal properties of D. officinale are based on its chemical composition. However, there are no reports on how different cultivation methods affect its chemical composition. In order to reveal this issue, samples of the D. officinale were collected in this study through tree epiphytic cultivation, stone epiphytic cultivation, and greenhouse cultivation. Polysaccharides were determined by phenol sulfuric acid method and secondary metabolites were detected by the UPLC-MS technique. In addition, with regards to metabolomics, we used multivariate analyses including principal component analysis (PCA) and orthogonal partial least squares analysis (OPLS-DA) to screen for differential metabolites which met the conditions of variable importance projection values >1, fold change >4, and p < 0.05. The differential metabolites were taken further for metabolic pathway enrichment analysis, which was based on the Kyoto Encyclopedia of Genes and Genomes (KEGG) database, and validated by antioxidant activity. Comparing the three groups of samples according to the standards of the ChP (2020 edition), the results showed that the polysaccharide content of the samples from stony epiphytic cultivation and greenhouse cultivation was significantly higher than that of the samples from live tree epiphytic cultivation. Metabolomic analysis revealed that there were 185 differential metabolites among the 3 cultivation methods, with 99 of the differential metabolites being highest in the stone epiphytic cultivation. The results of the metabolic pathway enrichment analysis showed that the different cultivation strategies mainly effected four carbohydrate metabolic pathways, five secondary metabolite synthesis pathways, six amino acid metabolic pathways, one nucleotide metabolism pathway, three cofactor and vitamin metabolism pathways, and one translation pathway in genetic information processing. Furthermore, D. officinale from stone epiphytic cultivation which had the best antioxidant activity was implicated in differential metabolite production. This study revealed the effects of different cultivation methods on the chemical composition of D. officinale and also provided a reference for establishing the quality control standards to aid its development and utilization.

Quality Assessment of Fried Oils from Different Street Food Vendors and Restaurants in Different Areas of Gilgit, Pakistan

The study was designed to estimate the quality of the frying oils used in northern areas of Pakistan. A cross-sectional analysis was performed to investigate the behavior and common practices of street food vendors (SFVs) regarding oil selection, food preparation, and awareness of rancid oil on human health. Seventy-Eight (78) commercial fried oil samples were evaluated based on the free fatty acid (FFAs), peroxide value (PV), moisture contents (MC), total polar matter (TPM), color, and iodine value (IV). The analysis showed that FFAs, PV, TPM, color, and IV significantly deviated from standard values provided by Pakistan Standard Quality Control Authority, (PSQCA) Pakistan. The SFVs used low-quality oil because of low price and ease of availability over quality, frying oil was changed infrequently and blended with new oil. Furthermore, the majority of SFVs were unaware of the hazards of rancid oil to human health, food handling practices were unsanitary, and cleaning methods were ineffective. Quality control, legislation, and SFVs safety and hygiene training are the most critical requirements to improve the overall quality of fried street foods in Gilgit, Pakistan.

Computational Systems Pharmacology and Molecular Docking Reveal an Anti-Apoptosis and Anti-Inflammatory Mechanism of Compound Angelica Ligusticum Wallichii Granules in the Treatment of Endometriosis.

Traditional medicine is a common treatment option for endometrioid-related symptoms. In the past few decades, Guixiong Xiaoyi formula has been widely used as a traditional medicine for the treatment of endometriosis. This study aimed to prepare compound Angelica Ligusticum wallichii granule (CALG) by modern technological methods and to study its pharmacodynamics and mechanisms of treating endometriosis. The ingredients of CALG were determined by UPLC-Q-TOF/MS. Target prediction of compounds and diseases was performed using databases, and the mechanisms of CALG were predicted by Gene Ontology and Kyoto Encyclopedia of Genes and Genomes and verified by molecular docking. Furthermore, a rat model of endometriosis was established to study the effects of CALG on endometriosis in vivo. CALG with good specificity, durability, and stability was obtained following a detailed preparation process and quality control standard. Using network systems pharmacology, 109 chemical compositions and 104 core targets were identified for the treatment of endometriosis. The composition-target-channel-disease network topology analysis of the top 15 chemical compositions of CALG showed that the beneficial effect of CALG on endometriosis was attributed to phenolic compounds. In addition, CALG treatment reduced the volume of ectopic uterine lesions, promoted apoptosis, inhibited the secretion of inflammatory cytokines, and increased HIF-1 expression in rats with endometriosis. CALG induces apoptosis and inhibits inflammation and is a promising drug for the treatment of endometriosis.

Imaged capillary isoelectric focusing employing fluorocarbon and methylcellulose coated fused silica capillary for characterization of charge heterogeneity of protein biopharmaceuticals

AbstractIdentifying and characterizing charge heterogeneity is essential for the successful development and production of biopharmaceuticals. Imaged capillary isoelectric focusing technology based on isoelectric point differentiation has been becoming the gold standard of quality and manufactory process control in the biopharmaceutical industry due to its high‐resolution characterization of protein charge variants with high throughput. Fluorocarbon‐coated capillaries are widely used in the imaged capillary isoelectric focusing to suppress the electroosmotic flow and minimize the protein adsorption onto the fused silica capillary inner surface. Additionally, polymers such as methylcellulose are usually added to the sample solution to serve as a dynamic capillary coating that improves the peak shape and resolution during the imaged capillary isoelectric focusing separation, especially for complex proteins. However, the addition of methylcellulose tends to result in tedious operation, “spike peaks” from bubble generation, and frequent capillary blockage during the imaged capillary isoelectric focusing separation. In addition, methylcellulose is not compatible with mass spectrometry and easily produces the contamination of mass spectrometry ion source when carrying out imaged capillary isoelectric focusing—mass spectrometry direct coupling. Recently, a new imaged capillary isoelectric focusing method was developed employing a methylcellulose‐coated capillary cartridge, to avoid the addition of methylcellulose which is then present throughout the whole analysis. When applied to protein drug characterization the established imaged capillary isoelectric focusing method demonstrated high repeatability, stable coatings, outstanding separation efficiency, and excellent isoelectric point differentiation. In addition, we compared imaged capillary isoelectric focusing separation using the methylcellulose‐coated capillary with that utilizing the routinely coated capillary such as fluorocarbon, illustrating that methylcellulose coating provided consistent results and could be seamlessly integrated into an existing drug discovery process. Finally, the methylcellulose‐coated fused silica capillary was applied to imaged capillary isoelectric focusing—mass spectrometry for characterizing protein charge variants allowing reliable identification of mass spectrometry after imaged capillary isoelectric focusing separation. This can greatly simplify the operation steps and prevent the contamination of mass spectrometry ion source that often results from using routinely coated capillaries ultimately making this an essential innovation of imaged capillary isoelectric focusing—mass spectrometry that greatly improves the imaged capillary isoelectric focusing compatibility with mass spectrometry.

Surgical treatment of heart failure in China: towards the era of artificial heart

The number of patients with heart failure in China is large, and the proportion of patients with end-stage heart failure continues to increase. The clinical effect of guideline-directed medications therapy for end-stage heart failure is poor. Heart transplantation is the most effective treatment for end-stage heart failure. But it is faced with many limitations such as the shortage of donors. In recent years, the research and development of artificial heart in China has made great progress. Three devices have been approved by the National Medical Products Administration for marketing, and another one is undergoing pre-marketing clinical trial. Since 2017, more than 200 cases of ventricular assist device implantation have been carried out in more than 34 hospitals in China. Among them, 70 patients in Fuwai Hospital, Chinese Academy of Medical Sciences had a 2-year survival rate of 90%. The first patient has survived more than 5 years with the device. More efforts should be put into the training of standardized technical team and quality control. Further research should be carried out in the aspects of pulsatile blood flow pump, fully implanted cable-free device, and improved biomaterial with better blood compatibility.

Perceived distress due to nasopharyngeal swab collection: Correspondence.

Dear Editor, we would like to correspond on the publication “Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial1”. Nasopharyngeal swab collection caused significant distress, which worsened with age, according to Kawade et al.1 The authors concluded that sample collectors should be properly trained, and parents should be encouraged to participate in the procedure.1 We agree that effective clinical specimen collection can lead to a high diagnostic yield and give patients the most comfort. However, regardless of the invasiveness of the treatment, fear of specimen collection is a prevalent problem among pediatric patients.2 Children may experience severe pain, worry, and suffering during a specimen collecting procedure.3, 4 Most young children who had clinical specimens collected reported having a lot of fear before the procedure.3 Children who experienced more moderate to severe pain throughout the specimen collection process were more likely to have high pre-procedural anxiety.4 To lessen the discomfort experienced during the procedure, anxiety-reducing therapies should be investigated.4 To lessen the subjects' worry and terror, a standard quality control for specimen collecting procedure as well as patient preparation is required. The reported distress may have been lessened had the authors applied effective distraction during the procedure. Any distraction method could have been chosen.2 Distraction tactics of any kind have been shown to significantly lower the perception of pain and anxiety.2 Kawade et al. should provide details on the distraction technique(s) used with the children in their study. None.

Systematic Quality Evaluation of Epimedium wushanense T. S. Ying Based on Two Quality Control Standards: Total Flavonoid Glycosides and Epimedin C.

Two quality control standards, total flavonoid glycosides of Epimedii Folium and epimedin C of Epimedii Wushanensis Folium, were used to systematically evaluate the quality of Epimedium wushanense T. S. Ying, so as to provide reference for its germplasm screening and resource utilization. Seven representative populations of E. wushanense covering its main distribution areas were uniformly sampled during the flowering period. There were significant quality differences among the populations of E. wushanense. According to the quality standard of total flavonoid glycosides, all populations were superior to the quality standard of the Chinese Pharmacopoeia for Epimedii Folium, with more than 1.5 % total flavonoid glycosides. The variation ranges of epimedin A, epimedin B, epimedin C, icariin and total flavonoid glycosides were 0.40-0.76 %, 0.51-0.83 %, 1.70-9.31 %, 0.40-1.23 % and 3.05-10.61 %, respectively. According to the quality standard of epimedin C, all populations were better than the quality standard of the Chinese Pharmacopoeia for Epimedii Wushanensis Folium, with more than 1.0 % epimedin C. The variation range of epimedin C was 2.22-10.06 %. When comparing the results of the two methods, a trend of slightly lower mean values was found for total flavonoid glycosides, except for the HBXW population. The quality of E. wushanense was superior to both the quality standard of Epimedii Folium and Epimedii Wushanense Folium in the Chinese Pharmacopoeia. Epimedin C was the most abundant component. Among the investigated populations, HBXW and HBGK exhibited the highest quality, and may provide excellent genetic resources for standardized cultivation. In addition, the habitat of these populations can also serve a reference for cultivation conditions.

Research on Quality Effect Evaluation of Medical Device Management in Shanghai Based on Radar Chart Method

Under the new pattern of high-quality development, the 2021 Briefing Report on Quality Control of Medical Devices in Shanghai Hospitals at All Levels will be subjected to secondary data processing, and the radar map analysis method will be used to visually evaluate the quality control effects and differences of medical devices in different types of hospitals in Shanghai. Analyze the quality level of medical device management in hospitals at all levels in Shanghai, study the key parts that affect the quality effect, and provide more theoretical basis for the effective control of medical device management quality. From the radar chart, the overall medical device level of tertiary hospitals is higher than that of secondary hospitals, and the overall coverage area is also larger. The overall quality balance of tertiary specialized hospitals needs to be improved urgently, mainly focusing on medical consumables and on-site inspection. There is a big gap in the quality control level of medical devices in other second-level hospitals, but the preparations for quality control training are more comprehensive. Hospital medical device management should pay more attention to specialized hospitals, low-level hospitals and socially run hospitals, and continuously improve the quality control system. At the same time, strengthen the standardization of medical device management and standardization of quality control, and promote the healthy and stable development of medical devices.

Identification of bibenzyls and evaluation of imitative wild planting techniques in Dendrobium officinale by HPLC-ESI-MSn.

Dendrobium officinale is a traditional Chinese herb with beneficial properties. Modern pharmacological studies show that bibenzyl is one of the antitumor active ingredients, but there is no effective quality control method for identifying ingredients. In this study, the composition of bibenzyls in Dendrobium officinale was studied by high-performance liquid chromatography coupled with electrospray ionization multistage mass spectrometry (HPLC-ESI-MSn ). A total of nine isolated bibenzyls and their glycosides, 22 bis (bibenzyls), and two phenylpropanol bibenzyl derivatives were identified. The results of HPLC characteristic chromatogram analysis and statistical analysis showed that the relative content of bibenzyls in wild imitation cultivation of samples had been significantly higher than that in greenhouse cultivation. In addition, the relative content of bibenzyls increased with the growth of the original plant. This study provided a scientific reference for controlling the quality of bibenzyls in Dendrobium officinale, developing the cultivation technology and improving the quality of Dendrobium officinale. HIGHLIGHTS: HPLC-ESI-MS/MS method for the analysis of bibenzyls and bis (bibenzyls) in Dendrobium officinale. Easy-to-use method facilitating rapid measurement of large sample quantities. The method requires only small volumes of samples for the analysis. Applicable for the establishment of Chinese medicine studies and the quality control standard of Chinese herbs.

Browning inhibition and shelf life of packaged air‐dried chestnut kernels

AbstractAir‐dried chestnut is a traditional snack in northern China, but no standardized quality control methods or commercial products are available. The browning of air‐dried chestnut kernels was inhibited by the combined use of 1.5% EDTA‐2Na, 1% pullulan, and 1% l‐cysteine. The air‐dried chestnut kernels were packed in three different bags (PB1, polyethylene (PE); PB2, polyamide resin (PA)/PE; and PB3, polyethylene terephthalate/PA/aluminum foil/PE), and stored at 4°C, 25°C, and 35°C, respectively. With increased storage time, the degree of browning, weight loss, and hardness increased, while the antioxidant activity and respiration rate decreased. The shelf life (SL) of packaged air‐dried chestnut kernels in different storage conditions was predicted by the Arrhenius equation, and the longest predicted shelf‐lives at 4°C, 25°C, and 35°C were 105.3 days (PB2), 19.5 days (PB3), and 10.8 days (PB1), respectively. The results provide guidance for inhibiting the browning of packaged air‐dried chestnut kernels and prolonging their SL during production and consumption.Practical applicationsAir‐dried chestnut has a crisp and sweet taste and low digestibility of starch, however, it has not been industrially processed until now. The optimal browning inhibitors and packaging materials of air‐dried chestnut kernel were explored, and the shelf life of packaged air‐dried chestnut kernel was predicted using Arrhenius equation. The results of this study will be beneficial to the commercial production of air‐dried chestnut kernel.

Quality Aspects of Herbal Drugs and its Formulation

To evaluate a high-quality medicine, herbal compositions must be standardised. The total of all aspects that directly or indirectly influence the safety, efficacy, and acceptance of a drug product is the quality of a herbal drug. The field of herbal drugs and formulations is developing quickly nowadays, and there is still much to learn about the standardisation of these products. However, the lack of a standardised parameter hurts herbal treatment. The primary constraints are the absence of standards for raw materials, processing techniques, and finished goods, product formulas, and absence of quality control standards. To assure the quality, safety, and effectiveness of herbal medicine using contemporary methods, it is required to measure the regulation of herbal medicine.

Predictive Value of KLASS-02-QC Assessment Score on KLASS-02 Surgical Outcomes: Validation of Surgeon Quality Control and Standardization for D2 Lymphadenectomy.

The aim of this study was to audit the 22 items and assessed each item's predictive value on surgical outcomes. The KLASS-02 trial revealed that the oncologic outcomes of laparoscopic distal gastrectomy are not inferior to open distal gastrectomy in patients with advanced gastric cancer. The surgeons participating in this trial were chosen based on the assessment scores from the KLASS-02-QC trial, which used 22 items for standardization of D2 lymphadenectomy and quality control. We reviewed proficiency scores (PSs) for 22 items for 20 surgeons who participated in KLASS-02. The surgeons were divided into 2 groups according to PS, and the perioperative outcomes of 924 patients enrolled in KLASS-02 were compared between groups. Each item's predictive value for perioperative outcome was then assessed using multivariable regression models. Of the total 924 patients, 529 were operated on by high-score surgeons (high PS) and 395 were operated on by low-score surgeons (low-PS). High-PS group had less intraoperative blood loss, longer operation times, and fewer complications, major complications, reoperations, and shorter first flatus and hospital stay than low-PS group ( P =0.006, P <0.001, P <0.001, P <0.001, P =0.042, P =0.013, and P <0.001, respectively). Some items used in KLASS-02-QC predicted perioperative outcomes, such as intraoperative blood loss, major complications, reoperation, and hospital stay. Although this study only analyzed data associated with qualified surgeons, the 22 items effectively assessed the surgeons based on PS. A high score was associated with longer operation times, but better perioperative outcomes.

Review on Quality Aspects of Herbal Drugs and its Formulations

To evaluate the quality of pharmaceuticals, it is crucial to consider the quality factors of herbal remedies herbal formulations. The total of all elements that directly or indirectly affect the product’s security, efficacy, and acceptance constitutes the quality of herbal medicines. The absence of formulation criteria, however, is a problem for herbal medications. The primary constraints are the absence of formulation for raw materials, processing techniques, and final goods, dose formulation, and the absence of quality control standards. To assure the quality, safety, and efficacy in herbal medicines using current, appropriate GMP standards.

Data quality and auditing within the Netherlands Heart Registration: using the PCI registry as an example.

The aim of this article is to present the method and results of the data quality control system and audit within the Netherlands Heart Registration (NHR) using data of patients treated with percutaneous coronary intervention (PCI) in the Netherlands as an example. The NHR is aDutch nationwide registry of all cardiac interventions, comprising data from all 71hospitals, of which 30are cardiac intervention or heart centres. Each year, within the NHR, data validation and verification is performed by standard quality controls and monitoring visits (audits). For the audit in 2019, asample of 50-100 medical records of patients treated with PCI in 2016 and 2017 were reviewed in each hospital by an independent auditor. The data received by the NHR were compared with the information in the hospitals' medical records. In total 12patient characteristics, 5intervention variables and 3outcome variables were screened. The value of avariable was considered discrepant if more than 10% of the medical records reviewed regarding this variable were not consistent with the reported data received by the NHR. For all variables together, the consistency was high, 97.6%. All variables, except multivessel disease (9.3% discrepancy in the 2622 medical records reviewed), had an accuracy above 95%. The results of the audit of the PCI medical records show that the overall quality of the data is high. For variables such as multivessel disease it is important to improve knowledge of the definitions and to train all those involved in the registration process.

The grading quality markers identification of Panax notoginseng under the guidance of traditional experience using untargeted metabolomics and anti-myocardial ischemia evaluation of zebrafish

Panax notoginseng (PN) was an edible Chinese herbal medicine. PN's current quality control standard cannot precisely match the traditional grading experience. In this study, under the guidance of the traditional grading experience, the combined metabolomics and biological effect evaluation were used to reveal the distinct chemical quality of PN. The quality of PN was evaluated by traditional experience and characterized by the electronic tongue. A zebrafish myocardial ischemia model was developed to verify the grading experience. The untargeted metabolomics method was used to identify and validate the grading markers of PN. The taste was the critical indicator for classifying the quality. Based on the experience sensory scores (ranged from 47.0 to 87.8), PNs could be divided into two grades. The experience scores were significantly associated with umami and richness of the electronic tongue(p<0.01). Besides, superior PN showed substantially stronger anti-myocardial ischemia activity(p<0.001). Thirty-nine differential components were found using UHPLC-LTQ-Orbitrap MS, of which 22 were identified. A new kind of grading quality markers alkynols in PN-associated efficacy was identified, which revealed stronger anti-myocardial ischemia activities than saponin. This study evaluated PN through untargeted metabolomics and anti-myocardial ischemia evaluation of zebrafish and proposed the critical role of alkynols in PN's quality classification.