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Computers in Biology and Medicine Mar 2024The HER2 expression status in breast cancer liver metastases is a crucial indicator for the diagnosis, treatment, and prognosis assessment of patients. And typical...
The HER2 expression status in breast cancer liver metastases is a crucial indicator for the diagnosis, treatment, and prognosis assessment of patients. And typical diagnosis involves assessing the HER2 expression status through invasive procedures like biopsy. However, this method has certain drawbacks, such as being difficult in obtaining tissue samples and requiring long examination periods. To address these limitations, we propose an AI-aided diagnostic model. This model enables rapid diagnosis. It diagnoses a patient's HER2 expression status on the basis of preprocessed images, which is the region of the lesion extracted from a CT image rather than from an actual tissue sample. The algorithm of the model adopts a parallel structure, including a Branch Block and a Trunk Block. The Branch Block is responsible for extracting the gradient characteristics between the tumor sub-environments, and the Trunk Block is for fusing the characteristics extracted by the Branch Block. The Branch Block contains CNN with self-attention, which combines the advantages of CNN and self-attention to extract more meticulous and comprehensive image features. And the Trunk Block is so designed that it fuses the extracted image feature information without affecting the transmission of the original image features. The Conv-Attention is used to calculate the attention in the Trunk Block, which uses kernel dot product and is responsible for providing the weight for the self-attention in the process of using convolution induced deviation calculation. Combined with the structure of the model and the method used, we refer to this model as TBACkp. The dataset comprises the enhanced abdominal CT images of 151 patients with liver metastases from breast cancer, together with the corresponding HER2 expression levels for each patient. The experimental results are as follows: (AUC: 0.915, ACC: 0.854, specificity: 0.809, precision: 0.863, recall: 0.881, F1-score: 0.872). The results demonstrate that this method can accurately assess the HER2 expression status in patients when compared with other advanced deep learning model.
Topics: Female; Humans; Algorithms; Biopsy; Breast Neoplasms; Liver Neoplasms
PubMed: 38277921
DOI: 10.1016/j.compbiomed.2024.108002 -
JRSM Open May 2024Commentators and professional organisations note that an expanding market in human milk-based products (HMBPs) could reduce breastfeeding, compromising maternal and...
OBJECTIVES
Commentators and professional organisations note that an expanding market in human milk-based products (HMBPs) could reduce breastfeeding, compromising maternal and infant health, and undermine public milk bank donations. We investigate whether English NHS trusts purchased these products and whether HMBP companies have marketed to them.
DESIGN
Freedom of Information (FOI) requests asking: (1) whether trusts obtained human milk; (2) if so, how; and (3) whether HMBP companies had approached them. We analysed trusts' responses qualitatively. In 2023, an FOI request to the Food Standards Authority (FSA) following a product recall.
SETTING
England.
PARTICIPANTS
One hundred and ninety-four NHS trusts, the FSA.
MAIN OUTCOME MEASURES
Obtaining human milk, approaches by companies, and trust responses to approaches.
RESULTS
One hundred and seventy-six trusts responded, 102 reporting human milk from milk banks. No trusts reported purchasing from companies in 2022. In 2023, the FSA confirmed six English hospitals used HMBPs from one company; an FOI for trusts' names was refused on law enforcement grounds. Two trusts reported participating in clinical trials funded by companies. Twenty-one reported approaches, using several strategies, including uninvited ward visits. Trusts rejected marketing based on guidance from: (1) trust dieticians or physicians; (2) regional regulatory bodies; (3) professional bodies; and (4) perceived application of an International Code on breastfeeding.
CONCLUSIONS
Companies market to trusts, adopting methods previously used by the formula industry. Trusts express confusion over whether this infringes agreements designed to promote breastfeeding. We encourage clarification and guidance for professionals and trusts to ensure safety, infant and maternal health, and protect public provision.
PubMed: 38699203
DOI: 10.1177/20542704241237658 -
Developmental Psychology Oct 2023Children's drawings of common object categories become dramatically more recognizable across childhood. What are the major factors that drive developmental changes in...
Children's drawings of common object categories become dramatically more recognizable across childhood. What are the major factors that drive developmental changes in children's drawings? To what degree are children's drawings a product of their changing internal category representations versus limited by their visuomotor abilities or their ability to recall the relevant visual information? To explore these questions, we examined the degree to which developmental changes in drawing recognizability vary across different drawing tasks that vary in memory demands (i.e., drawing from verbal vs. picture cues) and with children's shape-tracing abilities across two geographical locations (San Jose, United States, and Beijing, China). We collected digital shape tracings and drawings of common object categories (e.g., cat, airplane) from 4- to 9-year-olds (N = 253). The developmental trajectory of drawing recognizability was remarkably similar when children were asked to draw from pictures versus verbal cues and across these two geographical locations. In addition, our Beijing sample produced more recognizable drawings but showed similar tracing abilities to children from San Jose. Overall, this work suggests that the developmental trajectory of children's drawings is remarkably consistent and not easily explainable by changes in visuomotor control or working memory; instead, changes in children's drawings over development may at least partly reflect changes in the internal representations of object categories. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Topics: Child; Humans; China; Cues; East Asian People; Memory, Short-Term; United States; Asian
PubMed: 37768614
DOI: 10.1037/dev0001600 -
Frontiers in Neurology 2024Upwards of 50% of acute ischemic stroke (AIS) survivors endure varying degrees of disability, with a recurrence rate of 17.7%. Thus, the prediction of outcomes in AIS...
BACKGROUND AND OBJECTIVES
Upwards of 50% of acute ischemic stroke (AIS) survivors endure varying degrees of disability, with a recurrence rate of 17.7%. Thus, the prediction of outcomes in AIS may be useful for treatment decisions. This study aimed to determine the applicability of a machine learning approach for forecasting early outcomes in AIS patients.
METHODS
A total of 659 patients with new-onset AIS admitted to the Department of Neurology of both the First and Second Affiliated Hospitals of Bengbu Medical University from January 2020 to October 2022 included in the study. The patient' demographic information, medical history, Trial of Org 10,172 in Acute Stroke Treatment (TOAST), National Institute of Health Stroke Scale (NIHSS) and laboratory indicators at 24 h of admission data were collected. The Modified Rankine Scale (mRS) was used to assess the 3-mouth outcome of participants' prognosis. We constructed nine machine learning models based on 18 parameters and compared their accuracies for outcome variables.
RESULTS
Feature selection through the Least Absolute Shrinkage and Selection Operator cross-validation (Lasso CV) method identified the most critical predictors for early prognosis in AIS patients as white blood cell (WBC), homocysteine (HCY), D-Dimer, baseline NIHSS, fibrinogen degradation product (FDP), and glucose (GLU). Among the nine machine learning models evaluated, the Random Forest model exhibited superior performance in the test set, achieving an Area Under the Curve (AUC) of 0.852, an accuracy rate of 0.818, a sensitivity of 0.654, a specificity of 0.945, and a recall rate of 0.900.
CONCLUSION
These findings indicate that RF models utilizing general clinical and laboratory data from the initial 24 h of admission can effectively predict the early prognosis of AIS patients.
PubMed: 38938777
DOI: 10.3389/fneur.2024.1407152 -
Frontiers in Medicine 2024Human Immunodeficiency Virus (HIV) remains a global health challenge, and novel approaches to improve HIV control are significantly important. The cell and gene therapy...
Human Immunodeficiency Virus (HIV) remains a global health challenge, and novel approaches to improve HIV control are significantly important. The cell and gene therapy product AGT103-T was previously evaluated (NCT04561258) for safety, immunogenicity, and persistence in seven patients for up to 180 days post infusion. In this study, we sought to investigate the impact of AGT103-T treatment upon analytical treatment interruptions (ATIs). Six patients previously infused with AGT103-T were enrolled into an ATI study (NCT05540964), wherein they suspended their antiretroviral therapy (ART) until their viral load reached 100,000 copies/mL in two successive visits, or their CD4 count was reduced to below 300 cells/μL. During the ATI, all patients experienced viral rebound followed by a notable expansion in HIV specific immune responses. The participants demonstrated up to a five-fold increase in total CD8 counts over baseline approximately 1-2 weeks followed by the peak viremia. This coincided with a rise in HIV-specific CD8 T cells, which was attributed to the increase in antigen availability and memory recall. Thus, the protocol was amended to include a second ATI with the first ATI serving as an "auto-vaccination." Four patients participated in a second ATI. During the second ATI, the Gag-specific CD8 T cells were either maintained or rose in response to viral rebound and the peak viremia was substantially decreased. The patients reached a viral set point ranging from 7,000 copies/mL to 25,000 copies/mL. Upon resuming ART, all participants achieved viral control more rapidly than during the first ATI, with CD4 counts remaining within 10% of baseline measurements and without any serious adverse events or evidence of drug resistance. In summary, the rise in CD8 counts and the viral suppression observed in 100% of the study participants are novel observations demonstrating that AGT103-T gene therapy when combined with multiple ATIs, is a safe and effective approach for achieving viral control, with viral setpoints consistently below 25,000 copies/mL and relatively stable CD4 T cell counts. We conclude that HIV cure-oriented cell and gene therapy trials should include ATI and may benefit from designs that include multiple ATIs when induction of CD8 T cells is required to establish viral control.
PubMed: 38808136
DOI: 10.3389/fmed.2024.1342476 -
Journal of Epidemiology and Global... May 2024Mammography (MG) has demonstrated its effectiveness in diminishing mortality and advanced-stage breast cancer incidences in breast screening initiatives. Notably,...
BACKGROUND
Mammography (MG) has demonstrated its effectiveness in diminishing mortality and advanced-stage breast cancer incidences in breast screening initiatives. Notably, research has accentuated the superior diagnostic efficacy and cost-effectiveness of digital breast tomosynthesis (DBT). However, the scope of evidence validating the cost-effectiveness of DBT remains limited, prompting a requisite for more comprehensive investigation. The present study aimed to rigorously evaluate the cost-effectiveness of DBT plus MG (DBT-MG) compared to MG alone within the framework of Taiwan's National Health Insurance program.
METHODS
All parameters for the Markov decision tree model, encompassing event probabilities, costs, and utilities (quality-adjusted life years, QALYs), were sourced from reputable literature, expert opinions, and official records. With 10,000 iterations, a 2-year cycle length, a 30-year time horizon, and a 2% annual discount rate, the analysis determined the incremental cost-effectiveness ratio (ICER) to compare the cost-effectiveness of the two screening methods. Probabilistic and one-way sensitivity analyses were also conducted to demonstrate the robustness of findings.
RESULTS
The ICER of DBT-MG compared to MG was US$5971.5764/QALYs. At a willingness-to-pay (WTP) threshold of US$33,004 (Gross Domestic Product of Taiwan in 2021) per QALY, more than 98% of the probabilistic simulations favored adopting DBT-MG versus MG. The one-way sensitivity analysis also shows that the ICER depended heavily on recall rates, biopsy rates, and positive predictive value (PPV2).
CONCLUSION
DBT-MG shows enhanced diagnostic efficacy, potentially diminishing recall costs. While exhibiting a higher biopsy rate, DBT-MG aids in the detection of early-stage breast cancers, reduces recall rates, and exhibits notably superior cost-effectiveness.
PubMed: 38748377
DOI: 10.1007/s44197-024-00239-z -
Clinical Pharmacology and Therapeutics Jun 2024Drug recalls occur frequently and have the potential to impact considerable numbers of patients and healthcare providers. However, in the absence of a comprehensive...
Drug recalls occur frequently and have the potential to impact considerable numbers of patients and healthcare providers. However, in the absence of a comprehensive overview the extent of conducted recalls and their impact on patients remains unknown. To address this, we developed a comprehensive overview of drug recalls affecting patients. We compiled this overview based on the drug recall registrations from the Jeroen Bosch Hospital (JBZ), the University Medical Center Utrecht (UMCU), and the Royal Dutch Pharmacists Association (KNMP). A retrospective data analysis was conducted to identify drug recalls that affected patients. Specifically, we defined these as drug recalls that required patients to actively switch their drug to a different batch or brand of the same drug or to switch to a drug within the same or a different class of drugs. To quantify the impact, we used real-world drug dispensing data. Between January 1, 2017, and December 31, 2021, we identified 48 drug recalls that necessitated patients to make active changes to their medications an estimated 855,000 times. Most of the affected patients (292,000) were required to switch to a different brand of the same drug, whereas in 95,000 cases patients had to switch to a drug from another drug class. Our study suggests that a significant number of patients are affected by drug recalls. Future efforts are needed to elucidate patients' experiences and preferences regarding drug recalls, which could provide valuable insights to aid decision-making by relevant (national) authorities concerning drug recalls.
Topics: Humans; Netherlands; Retrospective Studies; Drug Recalls; Drug Substitution
PubMed: 38390768
DOI: 10.1002/cpt.3220 -
Pharmaceutical Medicine Mar 2024Cyproterone acetate (CPA) is a synthetic progesterone derivative introduced in the 1970s and prescribed as antiandrogenic therapy for inoperable prostate cancer, sexual...
BACKGROUND
Cyproterone acetate (CPA) is a synthetic progesterone derivative introduced in the 1970s and prescribed as antiandrogenic therapy for inoperable prostate cancer, sexual deviations in men, and signs of androgenization in women. In 2020, the CPA summary of product characteristics (SmPC) was revised to include an updated special warning and precaution about (1) the risk of meningioma with increasing cumulative dose and (2) contraindication in patients with meningioma or history of meningioma. A Direct Healthcare Professional Communication (DHPC) was distributed. The European Medicine Agency's Pharmacovigilance Risk Assessment Committee requested that marketing authorization holders in Europe conduct a survey to assess physicians' knowledge of the updated key safety information. The primary objective of this study was to measure physicians' awareness (i.e., did they receive and review the revised SmPC and DHPC) and level of knowledge and understanding of the key safety information pertaining to the restricted use of CPA monotherapy because of the risk of meningioma.
METHODS
This cross-sectional web-based survey was administered to dermatologists, endocrinologists, gynecologists, urologists, oncologists, psychiatrists, and general practitioners in France, Germany, Poland, Spain, and the Netherlands who had prescribed CPA monotherapy in the previous 12 months to assess awareness of the risk of meningioma associated with CPA monotherapy.
RESULTS
Of the 613 physicians who participated, 85% correctly indicated that CPA monotherapy should be prescribed with the lowest effective dose, 75% correctly indicated that the risk of meningioma increases with increasing cumulative CPA monotherapy doses, and 73% correctly indicated that treatment with CPA-containing products must be stopped permanently if a patient is diagnosed with meningioma. Overall, 40% of physicians reported having received the DHPC, and 42% reported having received the revised SmPC.
CONCLUSIONS
Despite low recall of receipt of the updated SmPC and DHPC, most physicians surveyed are aware of the meningioma risk and actions to mitigate the risk.
Topics: Male; Humans; Female; Cyproterone Acetate; Meningioma; Cross-Sectional Studies; Europe; Physicians; Meningeal Neoplasms; Phospholipid Ethers
PubMed: 38296916
DOI: 10.1007/s40290-023-00510-x -
Food Additives & Contaminants. Part A,... Jan 2024Analysis of N-nitroso folic acid, a nitrosamine impurity found in folic acid, is challenging due to the complex sample matrices. Many of such supplements contain not...
Analysis of N-nitroso folic acid, a nitrosamine impurity found in folic acid, is challenging due to the complex sample matrices. Many of such supplements contain not only a variety of vitamins, including vitamin A, Bs, C, D and E, but also other ingredients such as minerals, docosahexaenoic acid (DHA), glucose syrup, sugar, and herbs. On the other hand, the strength of folic acid is typically low, ranging from 50 µg to 5 mg per unit. In this study, a highly selective and sensitive LC-MS/MS method was developed to accurately quantify N-nitroso folic acid in supplements containing folic acid. The sample was extracted by 0.1% ammonia solution: MeOH (9:1, v/v) containing 5 ng/mL of N-nitroso folic acid-d (Isotope internal standard). The quantification was performed by MRM in negative ionization mode. Mobile phases A and B were 0.1% formic acid in deionized water and methanol, respectively. The method was validated and found to have sufficient linearity (R > 0.995), accuracy (recovery 83-110%), precision (RSD 3%) and low LOD, LOQ (4 and 10 µg/g respectively, with respect to folic acid). The method was applied to the determination of N-nitroso folic acid in 40 supplements containing folic acid with different strengths and formulation. The content of N-nitroso folic acid was found to be up to 898 ng/unit (1794 µg/g with respect to folic acid). It enabled regulatory actions, such as product recall, to safeguard public health from unsafe products.
Topics: Folic Acid; Chromatography, Liquid; Liquid Chromatography-Mass Spectrometry; Tandem Mass Spectrometry; Vitamins; Vitamin A; Reproducibility of Results
PubMed: 38100531
DOI: 10.1080/19440049.2023.2292603 -
Clinical Toxicology (Philadelphia, Pa.) Feb 2024We describe a rare food contamination of organically grown frozen green beans with , also called black night shade, which were widely available in supermarkets in the...
INTRODUCTION
We describe a rare food contamination of organically grown frozen green beans with , also called black night shade, which were widely available in supermarkets in the Netherlands.
CASE SERIES
To our knowledge, only three adults and one child were referred to the emergency department for observation after eating the contaminated green beans. Only minor symptoms were seen during observation. The remainder of the frozen green beans were obtained from the patients and sent for analysis within one day. Within two and a half days after the first case, a public safety warning and recall were launched.
DISCUSSION
Due to an increase in popularity of organic food, more incidents involving toxic weed contaminants like the one we describe in this report could happen when quality control in organic agriculture is insufficient. In this event, the critical control point obtained from the hazard analysis was insufficiently managed by the producer.
CONCLUSION
This report demonstrates the efficient collaboration between the Dutch Poisons Information Centre, treating physicians at the hospital and the Netherlands Food and Consumer Product Safety Authority in case of a possible public safety issue. Because of quick acting and collaboration between the involved parties, the product was quickly withdrawn from the market.
Topics: Adult; Child; Humans; Poisons; Solanum nigrum; Public Health; Drug Contamination; Hospitals
PubMed: 38451472
DOI: 10.1080/15563650.2024.2320838