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Perspectives on Psychological Science :... Sep 2023Episodic representations can be entertained either as "remembered" or "imagined"-as outcomes of experience or as simulations of such experience. Here, we argue that this... (Review)
Review
Episodic representations can be entertained either as "remembered" or "imagined"-as outcomes of experience or as simulations of such experience. Here, we argue that this feature is the product of a dedicated cognitive function: the metacognitive capacity to determine the of mental event simulations. We argue that mnemicity attribution should be distinguished from other metacognitive operations (such as reality monitoring) and propose that this attribution is a "cognitive gadget"-a distinctively human ability made possible by cultural learning. Cultural learning is a type of social learning in which traits are inherited through social interaction. In the case of mnemicity, one culturally learns to discriminate metacognitive "feelings of remembering" from other perceptual, emotional, action-related, and metacognitive feelings; to interpret feelings of remembering as indicators of memory rather than imagination; and to broadcast the interpreted feelings in culture- and context-specific ways, such as "I was there" or "I witnessed it myself." We review evidence from the literature on memory development and scaffolding, metacognitive learning and teaching, as well as cross-cultural psychology in support of this view before pointing out various open questions about the nature and development of mnemicity highlighted by our account.
Topics: Humans; Memory, Episodic; Mental Recall; Learning; Metacognition; Emotions; Imagination
PubMed: 36649218
DOI: 10.1177/17456916221141352 -
Signal Transduction and Targeted Therapy Oct 2023Long-term humoral immunity to SARS-CoV-2 is essential for preventing reinfection. The production of neutralizing antibody (nAb) and B cell differentiation are tightly...
Long-term humoral immunity to SARS-CoV-2 is essential for preventing reinfection. The production of neutralizing antibody (nAb) and B cell differentiation are tightly regulated by T follicular help (T) cells. However, the longevity and functional role of T cell subsets in COVID-19 convalescents and vaccine recipients remain poorly defined. Here, we show that SARS-CoV-2 infection and inactivated vaccine elicited both spike-specific CXCR3 T cell and CXCR3 T cell responses, which showed distinct response patterns. Spike-specific CXCR3 T cells exhibit a dominant and more durable response than CXCR3 T cells that positively correlated with antibody responses. A third booster dose preferentially expands the spike-specific CXCR3 T cell subset induced by two doses of inactivated vaccine, contributing to antibody maturation and potency. Functionally, spike-specific CXCR3 T cells have a greater ability to induce spike-specific antibody secreting cells (ASCs) differentiation compared to spike-specific CXCR3 T cells. In conclusion, the persistent and functional role of spike-specific CXCR3 T cells following SARS-CoV-2 infection and vaccination may play an important role in antibody maintenance and recall response, thereby conferring long-term protection. The findings from this study will inform the development of SARS-CoV-2 vaccines aiming to induce long-term protective immune memory.
Topics: Humans; SARS-CoV-2; COVID-19; COVID-19 Vaccines; Antibodies, Neutralizing; Vaccines, Inactivated
PubMed: 37802996
DOI: 10.1038/s41392-023-01650-x -
The Journal of Arthroplasty Aug 2023Orthopaedic devices comprise nearly 20% of devices on the market and 12% to 20% of these devices undergo a recall within 10 years. More than 95% of these devices are...
BACKGROUND
Orthopaedic devices comprise nearly 20% of devices on the market and 12% to 20% of these devices undergo a recall within 10 years. More than 95% of these devices are approved without supporting clinical data through the Food and Drug Administration's 510(k) pathway. The risk of recall of orthopaedic arthroplasty devices approved through the 510(k) pathway has not been previously studied.
METHODS
The FDA 510(k) database was queried for orthopaedic devices approved between January 01, 2008 and December 31, 2018 and subsequently codified to hip and knee arthroplasty devices using product codes. The database included 904 arthroplasty devices during the study period, with hip and knee making up 53.7% (485) and 46.3% (419) of devices, respectively. Information regarding numbers, dates, and reasons for recall were recorded. Cumulative incidence function was conducted to compare the risk of recall between hip and knee arthroplasty.
RESULTS
In total, 94 (19.4%) hip and 85 (20.3%) knee devices were recalled. The hazard of recall by 10 years for hip and knee arthroplasty devices was approximately 24%, with no statistical differences between each region. The most common causes of recall were process control and device design, accounting for 29.6% and 26.3% of recalls, respectively, with no significant difference between study groups.
CONCLUSION
The risk of recall for arthroplasty devices is more than that previously understood. Improved postmarket surveillance strategies along with increased physician participation in detecting and reporting device safety issues are necessary to strengthen patient safety.
Topics: United States; Humans; Medical Device Recalls; United States Food and Drug Administration; Product Surveillance, Postmarketing; Patient Safety; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
PubMed: 36773660
DOI: 10.1016/j.arth.2023.01.068 -
Nutrients Sep 2023The range of gluten-free food products available to consumers is steadily expanding. In recent years, recalls of food products have highlighted the importance of...
The range of gluten-free food products available to consumers is steadily expanding. In recent years, recalls of food products have highlighted the importance of accurate labeling of food products for the presence of wheat, other gluten-containing cereals, or gluten itself as refined ingredient. The purpose of this study was to gain more insights into recent food recalls related to undeclared gluten/wheat contamination and consumer experiences with these recalls. Recalls of products triggered by gluten contamination are relatively scarce and are not often triggered by a consumer complaint. The impact of these recalls on consumer trust was evaluated through an online survey that was distributed among supporters of Celiac Canada (CCA) and covered (i) strategies to adhere to a gluten-free diet, (ii) experiences with gluten-free recalls and their impact on consumer trust, and (iii) demographic information. Consumer concern regarding gluten-free product recalls is significant, but the concern regarding recalls is not heightened after experiencing a recall. Companies pursuing transparency in the process, identification of the source of contamination, and mitigation strategies going forward are likely to retain consumer trust in their product and brand. Based on the survey results, further efforts focusing on consumer education regarding interpreting nutrient labels, identifying sources of information on product recalls, and understanding procedures to follow upon suspected gluten contamination of a gluten-free product are recommended.
Topics: Humans; Diet, Gluten-Free; Food Labeling; Trust; Glutens; Product Recalls and Withdrawals; Celiac Disease
PubMed: 37836454
DOI: 10.3390/nu15194170 -
Photochemistry and Photobiology 2023The COVID-19 pandemic increased sales of portable UV-C devices as a means of inactivating the SARS-CoV-2 virus. Research suggests that excessive UV-C exposure to the...
The COVID-19 pandemic increased sales of portable UV-C devices as a means of inactivating the SARS-CoV-2 virus. Research suggests that excessive UV-C exposure to the eyes and skin can lead to side-effects, primarily photokeratitis and erythema, but these findings are limited to case studies. This study explores self-reported side-effects of UV-C devices by collating five waves of UK consumer survey data from April 2020-December 2021 (N = 26 864). 30%-46% of owners report a side-effect after using a device claiming to emit UV-C. However, detailed analysis of Wave 4 data (N = 309) highlights inconsistencies between reported and plausible side-effect(s) associated with skin or eye exposure from UV-C devices. Alternative explanations are considered, namely that the reported side-effect(s) were psychosomatic or misattributed to direct exposure of UV-C radiation. Data regarding awareness of warnings about device side-effect(s) supports the misattribution explanation. For risk assessment purposes, limited reliable information about specific irritation or injury to the eye and skin was found from self-reporting surveys. To optimize future data collection, we recommend addressing recall errors by: reducing the period under investigation, supplementing responses with empirical measures, and incentivizing respondents to provide accurate information about the make and model of the UV-C device.
PubMed: 36533869
DOI: 10.1111/php.13766 -
Research in Social & Administrative... Jun 2024The pharma supply chain comprises various parties including distributors, manufacturers, raw material suppliers, regulators, pharmacies, hospitals, and patients. Due to... (Review)
Review
BACKGROUND
The pharma supply chain comprises various parties including distributors, manufacturers, raw material suppliers, regulators, pharmacies, hospitals, and patients. Due to the product's complexity and transaction flows, an efficient traceability system is needed in the pharma supply chain to identify the current and all previous product owners. Digitizing the track and trace process significantly improves regulatory oversight and guarantees product quality. A distributed platform for shared data that is immutable, trustworthy, accountable, and transparent in the pharmaceutical supply chain could be built using blockchain-based drug traceability.
OBJECTIVE
This review aims to shed light on blockchain technology's significance and necessity for pharmaceutical supply chain management systems.
METHOD
A comprehensive literature review was performed between January 2017 and September 2023. The search was conducted to elaborate on blockchain technology. Blockchain is a software-based technology that logs and records transactions using a block structure arranged chronologically. Cryptography technology links and secures these blocks on a peer-to-peer network. Blockchain is anticipated to transform the pharmaceutical supply chain by giving all participants access to a single, straightforward system that provides transparency, security, and oversight of the end-to-end delivery of goods.
RESULT
In all, various literature data were included in this review. Using a supply chain powered by blockchain has many benefits. To begin with, it gives a thorough account of the entire procedure from start to finish. A single piece of software can manage the entire supply chain. Additionally, it increases communication between parties with permission. The enhanced security and traceability that blockchain offers is another important benefit. A blockchain system can track, trace, and recall products.
CONCLUSION
Blockchain-based pharmaceutical supply chain management enables the tracking of medicinal drug transactions from raw materials suppliers to end consumers. The pharma blockchain has the potential to enhance the security, integrity, data provenance, and functionality of the supply chain due to its transparency, immutability, and auditability.
Topics: Blockchain; Humans; Pharmaceutical Preparations; Drug Industry; Software
PubMed: 38423927
DOI: 10.1016/j.sapharm.2024.02.014 -
Lessons learned from postmarketing withdrawals of expedited approvals for oncology drug indications.The Lancet. Oncology Mar 2024In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).... (Review)
Review
In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Besides the EMA's conditional marketing authorisation programme and the FDA's Accelerated Approval Program, we observe a tendency towards fast approval for exploratory studies with non-randomised, uncontrolled designs and surrogate endpoints. This issue raises concerns about the robustness and effectiveness of accepted treatments, leaving patients and health-care professionals in a state of uncertainty. A substantial number of accelerated approvals have recently been withdrawn in the USA, with some still authorised in Europe, emphasising discrepancies in regulatory standards that affect both patients and society as a whole. We highlight examples of drugs, authorised on the basis of surrogate endpoints, that were later withdrawn due to an absence of overall survival benefit. Our findings address the challenges and consequences of accelerated approval pathways in oncology. In conclusion, this Policy Review calls for regulatory bodies to better align their procedures and insist on robust evidence, preferably through unbiased randomised controlled trials. Drug approval processes should prioritise patient benefit, overall survival, and quality of life to minimise risks and uncertainties for patients.
Topics: Humans; Drug Approval; Europe; Medical Oncology; Product Surveillance, Postmarketing; Safety-Based Drug Withdrawals
PubMed: 38423058
DOI: 10.1016/S1470-2045(23)00592-2 -
PloS One 2023Product-harm crises have detrimental effects on firm's sales, reputation, and financial value, requiring crisis managers to promptly adopt appropriate response...
Product-harm crises have detrimental effects on firm's sales, reputation, and financial value, requiring crisis managers to promptly adopt appropriate response strategies to mitigate these impacts. Situational Crisis Communication Theory (SCCT) guides managers to align responsibility attribution with response strategies. Using Chinese listed firms' product-harm crises sample from 2015 to 2021, this study analyzes the stock market's reaction to different response strategies. The event study method reveals that a passive strategy is more effective during the disclosure stage, and accept+no recall and deny+recall are conforming strategies during the initial response stage. Additionally, firms with a crisis history should assume greater responsibility when developing response strategies for product-harm crises, as crisis history amplifies negative effects. The results provide recommendations to help managers formulate appropriate strategies.
Topics: Commerce; Disclosure; Social Perception; Product Recalls and Withdrawals; Consumer Product Safety; Private Sector; Public Opinion; Truth Disclosure; China
PubMed: 37616251
DOI: 10.1371/journal.pone.0290548 -
Alzheimer's Research & Therapy Jan 2024Disease-modifying treatments for Alzheimer's disease highlight the need for early detection of cognitive decline. However, at present, most primary care providers do not... (Review)
Review
BACKGROUND
Disease-modifying treatments for Alzheimer's disease highlight the need for early detection of cognitive decline. However, at present, most primary care providers do not perform routine cognitive testing, in part due to a lack of access to practical cognitive assessments, as well as time and resources to administer and interpret the tests. Brief and sensitive digital cognitive assessments, such as the Digital Clock and Recall (DCR™), have the potential to address this need. Here, we examine the advantages of DCR over the Mini-Mental State Examination (MMSE) in detecting mild cognitive impairment (MCI) and mild dementia.
METHODS
We studied 706 participants from the multisite Bio-Hermes study (age mean ± SD = 71.5 ± 6.7; 58.9% female; years of education mean ± SD = 15.4 ± 2.7; primary language English), classified as cognitively unimpaired (CU; n = 360), mild cognitive impairment (MCI; n = 234), or probable mild Alzheimer's dementia (pAD; n = 111) based on a review of medical history with selected cognitive and imaging tests. We evaluated cognitive classifications (MCI and early dementia) based on the DCR and the MMSE against cohorts based on the results of the Rey Auditory Verbal Learning Test (RAVLT), the Trail Making Test-Part B (TMT-B), and the Functional Activities Questionnaire (FAQ). We also compared the influence of demographic variables such as race (White vs. Non-White), ethnicity (Hispanic vs. Non-Hispanic), and level of education (≥ 15 years vs. < 15 years) on the DCR and MMSE scores.
RESULTS
The DCR was superior on average to the MMSE in classifying mild cognitive impairment and early dementia, AUC = 0.70 for the DCR vs. 0.63 for the MMSE. DCR administration was also significantly faster (completed in less than 3 min regardless of cognitive status and age). Among 104 individuals who were labeled as "cognitively unimpaired" by the MMSE (score ≥ 28) but actually had verbal memory impairment as confirmed by the RAVLT, the DCR identified 84 (80.7%) as impaired. Moreover, the DCR score was significantly less biased by ethnicity than the MMSE, with no significant difference in the DCR score between Hispanic and non-Hispanic individuals.
CONCLUSIONS
DCR outperforms the MMSE in detecting and classifying cognitive impairment-in a fraction of the time-while being not influenced by a patient's ethnicity. The results support the utility of DCR as a sensitive and efficient cognitive assessment in primary care settings.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT04733989.
Topics: Humans; Female; Male; Dementia; Cognitive Dysfunction; Alzheimer Disease; Mental Status and Dementia Tests; Neuropsychological Tests
PubMed: 38167251
DOI: 10.1186/s13195-023-01367-7