Longitudinal evaluation of external quality assessment results for CA 15-3, CA 19-9, and CA 125.

Background: Tumor markers are established laboratory tools that help to diagnose, estimate prognosis, and monitor the course of cancer. For meaningful decision-making in patient care, it is essential that methods and analytical platforms demonstrate high sensitivity, specificity, precision, and comparability. Regular participation at external quality assessment (EQA) schemes is mandatory for laboratories. Here, a longitudinal evaluation of EQA data was performed to assess the performance of tumor marker assays over time. Methods: Longitudinal data of the cancer antigens (CA) 15-3 (n = 5,492), CA 19-9 (n = 6,802), and CA 125 (n = 5,362) from 14 INSTAND EQAs conducted between 2019 and 2023 were evaluated. A median of 197, 244 and 191 laboratories participated at the EQAs for CA 15-3, CA 19-9 and CA 125, respectively. Data evaluation encompasses intra- and inter-manufacturer specific variations over time, assay precision, and adherence to the EQA limits of ±24% for CA 15-3, ±27% for CA 19-9 and ±36% for CA 125. Results: The study showed median manufacturer-dependent differences of up to 107% for CA 15-3, 99% for CA 125, and even 549% for CA 19-9 between the highest and the lowest methods over the studied period. Regarding the normalized median of all methods, the values of the most deviant methods were 0.42 for CA 15-3, 7.61 for CA 19-9, and 1.82 for CA 125. Intra-manufacturer variability was generally low, with median coefficients of variation (CV) below 10%. As the methods were evaluated according to method-specific consensus values, most participants passed the EQAs within the acceptance criteria. When the criteria were consistently set at 24%, the central 90% of participants passed the EQAs in 78.6%-100% for CA 15-3 (with exception of AX), 89.3%-100% for CA 125, and 64.3%-100% for CA 19-9. Conclusion: While intra-method precision of most analytical platforms is acceptable for all three tumor markers, considerable inter-method variability was observed over the whole studied period demonstrating the necessity for better standardization and harmonization of the methods, development of international reference materials, and comprehensive commutability studies with patient samples.

Chemical characteristics and water stability evaluation of groundwater in the CKDu Zone of Sri Lanka.

Groundwater is the main source of drinking water for the rural population in the chronic kidney disease of unknown etiology (CKDu) zone of the North Central Province (NCP) in Sri Lanka. In this study, a total of 334 groundwater samples (311 dug wells, 21 tube wells and 2 springs) during the wet season from two aquifers in the NCP were collected, and investigated their chemical characteristics and evaluate their water quality, including groundwater chemistry, main ion sources, the corrosion and scaling potential of groundwater. The results showed that the two hydrochemical types of groundwater in the NCP were mainly of the Ca-HCO3, Na·Ca-HCO3 types, with the main HCO3-, Na+ and Ca2+ ions in both types of groundwater originating from silicate and evaporite salt dissolution and influenced by alternating cation adsorption, while the presence of NO3- was mainly anthropogenic. Evaluation of water stability using namely Langelier saturation index (LSI), Ryznar stability index (RSI), Puckorius scaling index (PSI) and Larson-Skold index (LS), indicated that most groundwater presents corrosion potential and has corrosion behavior tendency of metals to some degrees. The water quality of Polonnaruwa was better than that of Anuradhapura in the NCP, and when the groundwater was worse than the "good" grade, which must be properly treated before it is used as drinking water.

External Quality Assessment (EQA) scheme for serological diagnostic test for SARS-CoV-2 detection in Sicily Region (Italy), in the period 2020-2022.

OBJECTIVES: Since December 2019, worldwide public health has been exposed to a severe acute respiratory syndrome caused by Coronavirus-2. Serological testing is necessary for retrospective assessment of seroprevalence rates, and the determination of vaccine response and duration of immunity. For this reason, it was necessary to introduce a panel of tests able to identify and quantify Covid-19 antibodies. METHODS: As a Regional Reference Centre, the CRQ Laboratory (Regional Laboratory for the Quality Control) developed and conducted an External Quality Assessment (EQA) panel of assays, to evaluate the quality of various methods, that were used by 288 Sicilian laboratories, previously authorized on behalf of the Public Health Service. RESULTS: The performance test was based on pooled samples with different levels of concentration of antibodies. 97 , 98, and 95 % of the participating laboratories tested all samples correctly in 2020, 2021, and 2022 respectively. The best performance was observed in the test of total Ig. The general performance of laboratories improved over the years. CONCLUSIONS: The incorrect diagnosis had and could still have important implications on vaccination cycles. Only through the effort of laboratory professionals, and the extension of the EQA scheme, a better harmonization of methods, protocols, and thus results, to guarantee a better healthcare system, will be possible.

Evaluating the Commutability of Reference Materials for α-Fetoprotein: Accurate Value Assignment With Multiple Systems and Trueness Verification.

Background: The accurate measurement of α-fetoprotein (AFP) is critical for clinical diagnosis. However, different AFP immunoassays may yield different results. Appropriate AFP reference materials (RMs) were selected and assigned accurate values for applications with external quality assessment (EQA) programs to standardize AFP measurements. Methods: Forty individual clinical samples and six different concentrations of candidate RMs (Can-RMs, L1-L6) were prepared by the Beijing Center for Clinical Laboratories. The Can-RMs were assigned target values by performing five immunoassays, using WHO International Standard 72/225 as a calibrator, and sent to 45 clinical laboratories in Beijing for AFP measurements. The commutability of all RMs was assessed based on CLSI and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) approaches. Analytical performance was assessed for compliance based on accuracy (total error, TE), trueness (bias), and precision (CV). Results: The Can-RMs were commutable for all immunoassays using the CLSI approach and for 6 of 10 assay combinations using the IFCC approach. RMs diluted in WHO RM 72/225 were commutable among all assays with the CLSI approach, except for serum matrix (Autolumo vs. Roche analyzer) and diluted water matrix (Abbott vs. Roche/Mindray analyzer), whereas some inconclusive and non-commutable results were found using the IFCC approach. The average pass rates based on the TE, bias, and CV were 91%, 81%, and 95%, respectively. Conclusions: The commutability of the RMs differed between both evaluation approaches. The Can-RMs exhibited good commutability with the CLSI approach, suggesting their suitability for use with that approach as commutable EQA materials with assigned values and for monitoring the performance of AFP measurements.

Longitudinal evaluation of laboratory results and method precision in worldwide erythropoietin external quality assessments.

Introduction: This study presents a longitudinal analysis of external quality assessment (EQA) results for erythropoietin (EPO) determinations conducted between 2017 and 2022 with a continuously increasing number of participating laboratories. The aim of this work was to evaluate participant performance and methodological aspects. Methods: In each of the eleven EQA surveys, a blinded sample set of lyophilized human serum containing one sample with lower EPO concentrations (L) and one with higher EPO concentrations (H) was sent to the participating laboratories. Results: A total of 1,256 measurements were included. The median (interquartile range) fraction of participants not meeting the criteria of acceptance set at 20% around the robust mean of the respective survey was 9.5% (6.1%-10.7%) (sample L) and 9.1% (5.8%-11.8%) (sample H) but lacked a clear trend in the observed period. Some surveys exhibited unusually high interlaboratory variation, suggesting interfering components in the EQA samples. Different immunological methods and reagent manufacturers also showed variability in measurement outcomes to some extent. Conclusion: These findings highlight the need for continuous quality assessment in EPO measurements to ensure patient safety and identify areas for further research and investigation.

RWE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 16.

In this update, we discuss recent US FDA guidance offering more specific guidelines on appropriate study design and analysis to support causal inference for non-interventional studies and the launch of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) public electronic catalogues. We also highlight an article recommending assessing data quality and suitability prior to protocol finalization and a Journal of the American Medical Association-endorsed framework for using causal language when publishing real-world evidence studies. Finally, we explore the potential of large language models to automate the development of health economic models.

Automated Quality Assessment of Medical Images in Echocardiography Using Neural Networks with Adaptive Ranking and Structure-Aware Learning.

The quality of medical images is crucial for accurately diagnosing and treating various diseases. However, current automated methods for assessing image quality are based on neural networks, which often focus solely on pixel distortion and overlook the significance of complex structures within the images. This study introduces a novel neural network model designed explicitly for automated image quality assessment that addresses pixel and semantic distortion. The model introduces an adaptive ranking mechanism enhanced with contrast sensitivity weighting to refine the detection of minor variances in similar images for pixel distortion assessment. More significantly, the model integrates a structure-aware learning module employing graph neural networks. This module is adept at deciphering the intricate relationships between an image's semantic structure and quality. When evaluated on two ultrasound imaging datasets, the proposed method outshines existing leading models in performance. Additionally, it boasts seamless integration into clinical workflows, enabling real-time image quality assessment, crucial for precise disease diagnosis and treatment.

Implementation and evaluation of a system for assessment of the quality of long-term management of patients at a geriatric hospital.

BACKGROUND: The increasing aging population presents a significant challenge, accompanied by a shortage of professional caregivers, adding to the therapeutic burden. Clinical decision support systems, utilizing computerized clinical guidelines, can improve healthcare quality, reduce expenses, save time, and boost caregiver efficiency. OBJECTIVES: 1) Develop and evaluate an automated quality assessment (QA) system for retrospective longitudinal care quality analysis, focusing on clinical staff adherence to evidence-based guidelines (GLs). 2) Assess the system's technical feasibility and functional capability for senior nurse use in geriatric pressure-ulcer management. METHODS: A computational QA system using our Quality Assessment Temporal Patterns (QATP) methodology was designed and implemented. Our methodology transforms the GL's procedural-knowledge into declarative-knowledge temporal-abstraction patterns representing the expected execution trace in the patient's data for correct therapy application. Fuzzy temporal logic allows for partial compliance, reflecting individual and grouped action performance considering their values and temporal aspects. The system was tested using a pressure ulcer treatment GL and data from 100 geriatric patients' Electronic Medical Records (EMR). After technical evaluation for accuracy and feasibility, an extensive functional evaluation was conducted by an experienced nurse, comparing QA scores with and without system support, and versus automated system scores. Time efficiency was also measured. RESULTS: QA scores from the geriatric nurse, with and without system's support, did not significantly differ from those provided by the automated system (p < 0.05), demonstrating the effectiveness and reliability of both manual and automated methods. The system-supported manual QA process reduced scoring time by approximately two-thirds, from an average of 17.3 min per patient manually to about 5.9 min with the system's assistance, highlighting the system's efficiency potential in clinical practice. CONCLUSION: The QA system based on QATP, produces scores consistent with an experienced nurse's assessment for complex care over extended periods. It enables quick and accurate quality care evaluation for multiple patients after brief training. Such automated QA systems may empower nursing staff, enabling them to manage more patients, accurately and consistently, while reducing costs due to saved time and effort, and enhanced compliance with evidence-based guidelines.

Methodological Quality of Pulmonary Arterial Hypertension Treatment Evidence-Based Guidelines: A Systematic Review Using the AGREE II and AGREE REX Tools.

PURPOSE: Pulmonary arterial hypertension (PAH) is a progressive disease with a poor prognosis, and its management should be grounded in well-developed clinical practice guidelines (CPG). Thus, we critically assess the methodological quality of the available CPG for pharmacological treatments for PAH. METHODS: A systematic review (CRD42023387168) was performed in PubMed, Cochrane, Embase, and Tripdatabase (Jan-2023). Eligible records were appraised by four reviewers using the Appraisal of Guidelines, Research, and Evaluation Collaboration tool (AGREE II) and the complementary tool for assessing recommendations' quality and certainty, AGREE REX. Descriptive statistics were used to summarize the data. RESULTS: Overall, 31 guidelines, mainly authored by professional societies (90%), targeting only physicians as primary users (84%), were identified. Guidelines presented a moderate overall quality (scores of 63% and 51% in AGREE II and AGREE REX, respectively), with a few domains showing slight improvements over the years. AGREE II "Scope and Purpose" (94%) and "Presentation Clarity" (99%) domains obtained the highest scores. The items related to "Stakeholder involvement," "Editorial independence," and "Clinical applicability" (AGREE REX) were fairly reported. Conversely, CPG lacks rigor in development (32% score, AGREE II), scarcely discusses the role of stakeholders, and provides deficient data on the implementation of recommendations (scores of 35% and 46% in AGREE II and AGREE REX, respectively). No differences in the quality of guidelines published by different developers or countries were observed (p > 0.05). CONCLUSION: Methodological weaknesses are common among guidelines addressing PAH treatment, especially regarding scientific rigor, stakeholders' values and preferences, and facilitators and barriers to implementability. Particular attention should be given to developing future guidelines.

Sperm collection and characteristics analysis of the critically endangered Chinese pangolin (Manis pentadactyla).

The Chinese pangolin (Manis pentadactyla) is a critically endangered species. However, there is a paucity of research on the male reproductive gamete biology of this species. The present study was the first to systematically analyse the sperm characterization of the Chinese pangolin, including semen collection, sperm morphometry and ultrastructure. The semen of five male Chinese pangolins was successfully collected using the electroejaculation method. CASA (computer-assisted sperm analysis) was used to assess semen quality and take images for sperm morphometric analysis. Scanning electron microscopy (SEM) and transmission electron microscopy (TEM) were used for sperm ultrastructure observation. The results showed that the semen of the Chinese pangolin was yellow to pale yellow in colour, viscous, with a fishy odour, and a slightly alkaline pH of between 7.7 and 7.9. The head defects were the main sperm defects; there were 13 kinds of head defects counted in this study. The total sperm length, head length, head width and tail length were 67.62 ± 0.21 µm, 10.47 ± 0.06 µm, 1.33 ± 0.006 µm and 57.16 ± 0.20 µm, respectively. SEM observed that the spermatozoa had a rod-shaped head with a distinct apical ridge, which was different from most mammals and similar to that in avians and reptiles. Interestingly, TEM found that the acrosome membrane of the Chinese pangolin had a double membrane structure rather than a multiple bi-lamellar membrane structure as reported by the previous study. Collectively, this study contributes to the development of artificial breeding efforts and assisted reproductive techniques for the Chinese pangolin, as well as providing technical support for research on germplasm conservation of this species.

A full reference quality assessment method with fused monocular and binocular features for stereo images.

Aiming to automatically monitor and improve stereoscopic image and video processing systems, stereoscopic image quality assessment approaches are becoming more and more important as 3D technology gains popularity. We propose a full-reference stereoscopic image quality assessment method that incorporate monocular and binocular features based on binocular competition and binocular integration. To start, we create a three-channel RGB fused view by fusing Gabor filter bank responses and disparity maps. Then, using the monocular view and the RGB fusion view, respectively, we extract monocular and binocular features. To alter the local features in the binocular features, we simultaneously estimate the saliency of the RGB fusion image. Finally, the monocular and binocular quality scores are calculated based on the monocular and binocular features, and the quality scores of the stereo image prediction are obtained by fusion. Performance testing in the LIVE 3D IQA database Phase I and Phase II. The results of the proposed method are compared with newer methods. The experimental results show good consistency and robustness.

Motion Artifact Detection for T1-Weighted Brain MR Images Using Convolutional Neural Networks.

Quality assessment (QA) of magnetic resonance imaging (MRI) encompasses several factors such as noise, contrast, homogeneity, and imaging artifacts. Quality evaluation is often not standardized and relies on the expertise, and vigilance of the personnel, posing limitations especially with large datasets. Machine learning based on convolutional neural networks (CNNs) is a promising approach to address these challenges by performing automated inspection of MR images. In this study, a CNN for the detection of random head motion artifacts (RHM) in T1-weighted MRI as one aspect of image quality is proposed. A two-step approach aimed to first identify images exhibiting pronounced motion artifacts, and second to evaluate the feasibility of a more detailed three-class classification. The utilized dataset consisted of 420 T1-weighted whole-brain image volumes with isotropic resolution. Human experts assigned each volume to one of three classes of artifact prominence. Results demonstrate an accuracy of 95% for the identification of images with pronounced artifact load. The addition of an intermediate class retained an accuracy of 76%. The findings highlight the potential of CNN-based approaches to increase the efficiency of post-hoc QAs in large datasets by flagging images with potentially relevant artifact loads for closer inspection.

Microbial Health Risks of Cryptosporidium parvum and Giardia lamblia in Tropical Coastal Water in Araromi, Nigeria.

Objective: Giardia and Cryptosporidium are enteric protozoa that can cause a variety of gastrointestinal diseases, especially in vulnerable people like children, the elderly, and those with impaired immune systems. In order to ascertain the microbiological quality of the recreational water from Araromi Beach in Ilaje Local Government Area, Ondo State, Nigeria. This risk assessment is of great significance to human health protection against waterborne diseases. The aim of this study was to determine the microbial quality of recreational water from Araromi Beach in Ilaje Local Government Area, Ondo State, Nigeria. Methods: Microscopic examination of Cryptosporidium and Giardia oocysts were done. Results: Results revealed maximum occurrence of Cryptosporidium parvum (20 oocysts/100 mL) of water sample in the month of April and maximum occurrence of Giardia lamblia (300 cysts/100 mL) of water sample in the month of June. Additionally, according to Kolmogorov-Smirnov tests for normalcy Ho =0.05, Giardia lamblia and Cryptosporidium parvum were not regularly distributed in the water samples collected from the beach throughout the study period. The average likelihood of contracting Giardia lamblia and Cryptosporidium parvum infections after consuming 100 mL of beach water was 0.96 and 0.35, respectively. The risks of infection associated with Cryptosporidium parvum was lower than those associated with Giardia lamblia in water from the beach, but were both above the acceptable risk limit of 10-4. Conclusion: The results of this study indicate that Giardia and Cryptosporidium may represent serious health hazards to people who engage in aquatic activities. Adopting a comprehensive strategy that includes regular inspections, enhanced detection techniques, and the prevention of aquatic environment pollution may provide clean and safe recreational water for all, thereby safeguarding the public's health.

Super-resolution deep-learning reconstruction for cardiac CT: impact of radiation dose and focal spot size on task-based image quality.

This study aimed to evaluate the impact of radiation dose and focal spot size on the image quality of super-resolution deep-learning reconstruction (SR-DLR) in comparison with iterative reconstruction (IR) and normal-resolution DLR (NR-DLR) algorithms for cardiac CT. Catphan-700 phantom was scanned on a 320-row scanner at six radiation doses (small and large focal spots at 1.4-4.3 and 5.8-8.8 mGy, respectively). Images were reconstructed using hybrid-IR, model-based-IR, NR-DLR, and SR-DLR algorithms. Noise properties were evaluated through plotting noise power spectrum (NPS). Spatial resolution was quantified with task-based transfer function (TTF); Polystyrene, Delrin, and Bone-50% inserts were used for low-, intermediate, and high-contrast spatial resolution. The detectability index (d') was calculated. Image noise, noise texture, edge sharpness of low- and intermediate-contrast objects, delineation of fine high-contrast objects, and overall quality of four reconstructions were visually ranked. Results indicated that among four reconstructions, SR-DLR yielded the lowest noise magnitude and NPS peak, as well as the highest average NPS frequency, TTF50%, d' values, and visual rank at each radiation dose. For all reconstructions, the intermediate- to high-contrast spatial resolution was maximized at 4.3 mGy, while the lowest noise magnitude and highest d' were attained at 8.8 mGy. SR-DLR at 4.3 mGy exhibited superior noise performance, intermediate- to high-contrast spatial resolution, d' values, and visual rank compared to the other reconstructions at 8.8 mGy. Therefore, SR-DLR may yield superior diagnostic image quality and facilitate radiation dose reduction compared to the other reconstructions, particularly when combined with small focal spot scanning.

Subjective performance evaluation of bitrate allocation strategies for MPEG and JPEG Pleno point cloud compression.

The recent rise in interest in point clouds as an imaging modality has motivated standardization groups such as JPEG and MPEG to launch activities aiming at developing compression standards for point clouds. Lossy compression usually introduces visual artifacts that negatively impact the perceived quality of media, which can only be reliably measured through subjective visual quality assessment experiments. While MPEG standards have been subjectively evaluated in previous studies on multiple occasions, no work has yet assessed the performance of the recent JPEG Pleno standard in comparison to them. In this study, a comprehensive performance evaluation of JPEG and MPEG standards for point cloud compression is conducted. The impact of different configuration parameters on the performance of the codecs is first analyzed with the help of objective quality metrics. The results from this analysis are used to define three rate allocation strategies for each codec, which are employed to compress a set of point clouds at four target rates. The set of distorted point clouds is then subjectively evaluated following two subjective quality assessment protocols. Finally, the obtained results are used to compare the performance of these compression standards and draw insights about best coding practices.

Incidence of complications after nonoperating room anesthesia in children in a low- and middle-income country: A prospective and observational study.

INTRODUCTION: Nonoperating room anesthesia is a growing field of medicine that can have an increased risk of complications, particularly in low- and middle-income countries. AIMS: The aim of this study was to describe the incidence of complications after pediatric nonoperating room anesthesia and investigate its risk factors. METHODS: In this prospective observational study, we included all children aged less than 5 years who were sedated or anesthetized in the radiology setting of a university hospital in a low- and middle-income country. Patients were divided into two groups: complications or no-complications groups. Then, we compared both groups, and univariable and multivariable logistic regression models were used to investigate the main risk factors for complications. RESULTS: We included 256 children, and the incidence of complications was 8.6%. The main predictors of nonoperating room anesthesia-related morbidity were: critically-ill children (aOR = 2.490; 95% CI: 1.55-11.21), predicted difficult airway (aOR = 5.704; 95% CI: 1.017-31.98), and organization insufficiencies (aOR = 52.6; 95% CI:4.55-613). The preanesthetic consultation few days before NORA protected against complications (aOR = 0.263; 95%CI: 0.080-0.867). CONCLUSIONS: The incidence of complications during NORA among children in our radiology setting remains high. Investigating predictors for morbidity allowed high-risk patient selection, which allowed taking precautions. Several improvement measures were taken to address the organization's insufficiencies.

Quality-Aware Signal Processing Mechanism of PPG Signal for Long-Term Heart Rate Monitoring.

Photoplethysmography (PPG) is widely utilized in wearable healthcare devices due to its convenient measurement capabilities. However, the unrestricted behavior of users often introduces artifacts into the PPG signal. As a result, signal processing and quality assessment play a crucial role in ensuring that the information contained in the signal can be effectively acquired and analyzed. Traditionally, researchers have discussed signal quality and processing algorithms separately, with individual algorithms developed to address specific artifacts. In this paper, we propose a quality-aware signal processing mechanism that evaluates incoming PPG signals using the signal quality index (SQI) and selects the appropriate processing method based on the SQI. Unlike conventional processing approaches, our proposed mechanism recommends processing algorithms based on the quality of each signal, offering an alternative option for designing signal processing flows. Furthermore, our mechanism achieves a favorable trade-off between accuracy and energy consumption, which are the key considerations in long-term heart rate monitoring.

Establishing Quality Assurance for HIV-1 Rapid Test for Recent Infection in Thailand through the Utilization of Dried Tube Specimens.

The present study focuses on establishing the quality assurance of laboratories for recent infections (RTRI) in Thailand. We developed a cold-chain independent method, using fully characterized plasma obtained from the Thai Red Cross Society, and prepared as dried tube specimens (DTS). Twenty microliters of HIV-seronegative, recent, and long-term infected samples were aliquoted into individual tubes and dried at room temperature, 20-30 degrees Celsius, in a biosafety cabinet overnight to ensure optimal preservation. The DTS external quality control and external quality assessment were tested for homogeneity and stability following the ISO/Guide 35 guidelines. The DTS panels were distributed to 48 sites (FY 2022) and 27 sites (FY 2023) across 14 and 9 provinces, respectively, in Thailand. The results from participating laboratories were collected and evaluated for performance. The results were scored, and acceptable performance criteria were defined as the proportion of panels correctly tested, which was set at 100%. The satisfactory performance ranged from 96% to 100% and was not significantly different among the 13 health regions. The developed and implemented DTS panels can be used to monitor the quality of RTRI testing in Thailand.