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Francesca De Angelis (ITALY) Chitosan-Coenzyme Q10 as Bone Graft Materials Covid Pandemic Towards Increased Risk of Stunting. Open in a separate window (10). R i m g υ i m g ′ = R λ R γ that will be certainly helpful in diagnosing some symptoms of COVID All movement is prohibited outside of those windows, including both vehicular (rule) stating that hiding COVID symptoms is against religion and that.
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The artificial cell swarm optimization procedure mimics the artificial cells as the search agents. The actual artificial cell division approach [46] is slightly modified to design the optimization procedure.
The incorporated modifications are listed below [47] :. The hierarchical tree structure is formed throughout the generations due to the artificial cell division process. Swarms of artificial cells are considered in the optimization process to take part in the artificial cell division process.
No communication is allowed between any pair of artificial cells. Lifespan of the k th artificial cell at a certain timestamp t s is an important parameter and it is directly dependent on the fitness value f i t n e s s k as given in Eq. A huge number of swarms can significantly increase the fitness evaluations and a small number of swarms can increase time to converge and therefore, is essential to decide the swarm count moderately.
In this work, the swarm count is considered is a fixed parameter. One artificial cell can produce some new cells and the production of new cells occur at a certain distance which is inversely dependent on the fitness of the producer cell as expressed in Eq. The distance between the k th cell and any of the l th cell, which are produced from the same parent cell, must be same. Therefore, if a cell is near to global optima, then it can generate some other cells at a smaller distance and vice-versa.
Smaller steps help to search the nearest portions of the global optima cautiously so that the global optima may not be missed accidentally.
A cell does not have any effect on the population once its lifespan is over. This property helps to maintain the size of the population and prevents getting overpopulated. The successor cells of a cell can produce some other cells by the cell division process to maintain the population. The life span of a cell can belong it belongs to the near-optimal area.
The quality of a population is evaluated using the lambda function which is given in Eq. Algorithm 1 illustrates the artificial cell swarm optimization approach in brief [47]. The proposed approach adopts the type 2 fuzzy logic-based clustering approach to effectively model and handle the random uncertainties.
In most real-life applications, the uncertainty cannot be predicted in advance. A wide range of input types can produce random uncertainties. Hence, it is essential to cope up with the random uncertainties in real-life scenarios. The fuzzy C-means clustering approach is one of the widely used clustering approaches which is suitable to various problems of different domains [48] , [49] , [50] , [51].
The main reason behind the increasing popularity of fuzzy systems is the suitability of this approach in different scenarios where the crisp clustering approaches do not perform well. A single point can be a member of more than one cluster at the same time with some membership values.
The total sum of all membership values for a certain point must be one. So, the value of the membership can be anything between 0 and 1. The dissimilarity function which is optimized by the fuzzy C-means clustering approach is given in Eq. The cluster centers can be updated using Eq. The type 2 fuzzy logic systems use separate sets of membership values that are also fuzzy in nature.
This approach allows efficient modeling of dynamic input uncertainties by providing additional degrees of freedom. In this work, the type 2 fuzzy logic-based clustering approach is adopted to overcome some of the common problems of type 1 fuzzy systems like noise sensitivity, relative membership values, etc. It is essential to improve the outcome of the segmentation process. The uncertainty of a point must be decided depending on the membership value i.
So, a lower membership value indicates higher uncertainty and vice-versa. Some of the basic reason behind the adoption of type 2 fuzzy system in this work is listed below [53] :.
The membership value in type 2 fuzzy systems can be calculated using Eq. The proposed approach does not require Eq. The artificial cell swarm optimization process will guide the proposed approach to determine the optimal cluster centers. The type 2 fuzzy clustering system can be easily understood from algorithm 2 and the schematic diagram of the type 2 fuzzy system can be visualized from Fig.
The ever-growing technology allows us to increase the quality of the image acquisition hardware. High-quality biomedical images can be acquired from various biomedical image acquisition devices and it is helpful in a precise analysis of the biomedical images.
Automated biomedical image analysis devices are facing some challenges due to the increasing quality of biomedical images. A high amount of spatial information creates severe problems for automated and computer-aided diagnostic systems because medical diagnostic systems demand quick and accurate results. Image segmentation plays a vital role in many automated computer-aided image analysis systems.
It is essential to generate precise reports within the stipulated amount of time to provide accurate treatment to the patients. To handle this situation effectively and to accelerate the screening process of the COVID infection, a superpixel-based novel approach is proposed in this work to segment the CT scan images. Superpixels are useful to represent a set of pixels in a computation-friendly manner.
Different approaches can be found in the literature to find the superpixel image from an input image [54] , [55] , [56]. Some superpixel computation methods like mean shift [54] and watershed [56] produce irregular superpixels and some methods like SLIC [55] generate regular superpixels. Meanshift and watershed approaches are more useful due to the capability to generate irregular superpixels.
The watershed approach is simpler to implement compared to the mean-shift approach but it is sensitive to the noise which is not at all desirable for the image segmentation approaches. In this work, the noise sensitivity of the watershed approach is removed with the help of the gradient image, which is generated using the approach, proposed in [57].
The obtained gradient image is processed using the morphological erosion and dilation-based reconstruction operations, which are given in Eqs.
Here, s e is the structuring element and it is an important parameter that controls the segmented outcome. The size of the structuring element is subjective and depends on the image under consideration. Practically, it is not possible to determine different structuring elements which are of various sizes, depending on the image. Therefore, the pointwise maximum value is computed using Eq.
The number of superpixels is inversely dependent on the size of the structuring elements. It can be easily understood in Fig.
The image considered in these two figures is the T e s t 01 image [58] please refer to Table 3. Dependency of the number of superpixels on the size of the disk structuring element a — h superpixel images obtained using the disk structuring element of size 3 to 10 respectively, i Size of the structuring element vs.
Dependency of the number of superpixels on the size of the square structuring element a — h superpixel images obtained using the square structuring element of size 3 to 10 respectively, i Size of the structuring element vs.
A very small lower bound is not desirable because it will produce very small regions and some essential edge information can be lost. So, the threshold value can be adjusted as per the requirement and depending on the available resources. The conventional fuzzy C-means clustering approach often overlooks some important spatial information that can be costly in terms of the segmentation performance. Some approaches try to solve this problem by considering and blending some local spatial information in the objective function but it increases the computational cost and therefore not suitable on many occasions.
Superpixels can help in this context by over-segmenting an image in many small, perceptually uniform, and homogeneous regions. In this work, the CT images are first processed to determine the superpixels using the proposed approach and then the fuzzy artificial cell swarm optimization approach is used to determine the segmented image by finding the optimal clusters.
As discussed earlier, the type 2 fuzzy system is used to perform the segmentation. The fuzzy objective function which is given in Eq. To incorporate the advantages of the superpixel, it is necessary to modify the fuzzy objective function. The representative value is used in the objective function, and the modified objective function is given in Eq.
The cluster centers can be updated and guided by the artificial cell swarm optimization and therefore, no equation is required to compute the updated positions of the cluster center. This approach is not dependent on the selection of the initial cluster centers. The proposed procedure is given in algorithm 3 and the schematic flow diagram is given in Fig. As discussed earlier, the properly annotated ground truth segmented images may not be available always, and therefore, some standard intrinsic cluster evaluation methods are used here to evaluate the proposed approach quantitatively.
The proposed methods are applied to the images and the test results are demonstrated with the 10 CT scan images that are randomly selected which are obtained from different countries of the world. Table 3 gives a brief overview of the test images and the test images along with their histograms are given in Fig. The experiments are performed in the MatLab Ra on a computer that is equipped with an Intel i3 processor and 4 GB main memory. The proposed method is compared with some metaheuristic optimization-based image segmentation approaches like modified genetic algorithm [67] , modified PSO [68] , improved bat algorithm [69] and modified cuckoo search method [70] in both qualitative and quantitative manner.
The visual comparison is presented in Fig. The acceptable values are highlighted in boldface. The comparisons and evaluations are performed for different numbers of clusters. A comparative study of different approaches using T e s t 01 for different number of clusters.
Performance evaluation of different approaches using Davies—Bouldin index The highlighted values indicates acceptable values. Performance evaluation of different approaches using Xie—Beni index The highlighted values indicates acceptable values.
Performance evaluation of different approaches using Dunn index The highlighted values indicates acceptable values. From the qualitative and quantitative results, it can be observed that the proposed SUFACSO approach outperforms some state-of-the-art works and can produce realistic outputs that are certainly helpful for the interpretation of the real-life CT scan images and therefore, this approach can be helpful for the early screening purposes.
At the end of each table, the average performance of the five approaches is reported which is beneficial to understand the overall performance of these methods for the different number of clusters and different cluster validity indices. In the case of average, the column-wise optimal values are highlighted instead of highlighting the row-wise optimal values. The row-wise highlighted values talk about the performance of the individual algorithm for the different number of clusters whereas the column-wise highlighted values help to understand the performance of the individual algorithms.
It can be observed that the proposed approach outperforms other approaches for most of the number of clusters as well as for most of the validity indices. For example, on a total of 16 occasions i. These comparative results are graphically presented in Fig. In X -axis the number of clusters and in the Y -axis, the values of the corresponding validity index are plotted. The experiments are carried out for the different numbers of clusters. A particular approach may perform well for a particular cluster count.
That is why the average values of all experiments are reported at the end of each table for better interpretation. It can be observed that the proposed approach can optimize different objective functions effectively. Actually, the experiments are carried out on CT images in the first phase and CT images in the second phase. It is already mentioned in Section 5. Results that are obtained from all images are not possible to report in this stipulated amount of space.
Therefore, only some results that are obtained from some selected images are reported. Apart from these tests, the proposed approach is also compared with some of the active contour models based on some standard parameters like accuracy, precision, and recall. This comparison is performed by using the database that is available at [71]. This dataset is created by collecting sample images from 49 patients with age range 32—86 years.
The obtained average results are reported in Table 8. The rate of convergence is an important parameter to be studied. The performance evaluation remains incomplete without studying and comparing the convergence of different algorithms. The convergence analysis gives a clear view of the comparative performance of different algorithms for the different numbers of clusters. The graphical analysis of the convergence is presented in this subsection using the image T e s t 01 for the Dunn index.
In Fig. In a single plot, four separate curves are indicating four different clusters. These curves show that the proposed approach can efficiently segment the images for a higher number of clusters. Moreover, the proposed approach also outperforms some other methods in terms of convergence besides quantitative and qualitative performance. The time complexity is an important aspect that is to be analyzed.
From the detailed discussion of the proposed approach, it can be noticed that the proposed approach can be viewed as a two-phase procedure where the watershed-based computation approach is used to determine the superpixel image from the underlying image in the first phase and the optimal segmented outcome is computed in the second phase.
The task of optimization is performed using the proposed fuzzy ACSO approach. The gradient information of an image is used to avoid the noise sensitivity of the water-shed based superpixel computation process. The watershed-based technique is a simple method to compute the superpixel and the implementation follows linear complexity [56]. It is quite inspiring and lucrative to adopt this approach on different occasions.
In the optimization part, the fuzzy objective function is optimized by using the proposed fuzzy ACSO method. The ACSO approach is an effective and efficient approach that can be executed in linear time [47].
So, the proposed approach is efficient enough and can be effectively used in various real-life problem-solving scenarios. This approach can effectively process high-quality images with the help of the proposed superpixel-based approach that is an essential quality for the real-life application of an image segmentation approach. This approach removes the dependency of choice of the initial cluster centers as well as the ACSO approach determines the optimal cluster centers by optimizing some validity indices.
These advantages motivate us to apply the proposed approach to automatically segment the radiological images that will be certainly helpful in diagnosing some symptoms of COVID The experimental outcomes show the efficiency of the proposed approach. Under this pandemic environment, this work is designed hoping that it can help physicians and other domain experts to some extent in the early diagnosis of the disease. Early diagnosis can prevent the drastic spread of this highly infectious virus.
Quantitative results do not have any direct implications in real-life diagnosis. The segmented outcomes are useful in the diagnosis process. Physicians can investigate the segmented outcomes to find some prominent and common features as mentioned in Table 2.
The segmented images will be helpful in the easy interpretation of the radiological images. The proposed SUFACSO approach is an efficient image segmentation approach that can effectively segment the radiological images that highly useful in the easy interpretation of these images.
There is a high possibility that a suspected patient can spread the disease in the community completely unwillingly. The proposed approach can reduce this chance because an initial screening can be performed by the physicians comfortable with the help of the proposed SUFACSO approach. It is worth mentioning here that the proposed approach is neither a replacement of the RT-PCR test nor it can confirm the presence of the virus accurately.
However, this approach can be helpful in an initial screening at an early stage that will restrict the spread of this highly infectious virus by separating suspected patients from the rest of the community. The obtained results indicate that the proposed approach is suitable for real-life scenarios and also performs efficiently. This approach can be easily adapted for the automated screening purposes of the COVID infected patients.
It is assumed the quality of the CT scan images is considerably high and the performance of the proposed approach is not verified against the presence of noise. It will be interesting to study the proposed approach in the presence of noise.
The scalability of the proposed approach to different types of biomedical images can be explored in future studies. Missing manual annotations can jeopardize the generalizability of the proposed work. On the other hand, the obtained results are quite promising and encouraging. From the best of the knowledge of the authors, there is no publicly available manually annotated dataset for the chest CT scan images of the COVID positive cases. Although the proposed approach is efficient enough to segment the CT scan images automatically and produces realistic segmented outcomes still, some important drawbacks can be observed in this proposed approach that can be addressed in the subsequent works.
One important drawback of the proposed approach is that it cannot automatically determine the number of clusters and it can be overcome in future works. Automated estimation of the clusters can make this approach more realistic, robust, and application friendly.
The proposed method can handle only a single objective at a time. Therefore, the proposed approach is not suitable for multi-objective optimization issues unless enhanced further. The number of images in the dataset is not very large. So, the proposed approach can also be tested on some additional CT images of COVID infection as well as on some standard dataset of the biomedical images.
Published online Arch Intern Med. The EU 7 -PIM list: a list of potentially inappropriate medications for older people consented by experts from seven European countries. Eur J Clin Pharmacol. Introduction: A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient [1].
Use of medicinal products in children is identified as a risk factor for occurrence of medication errors [2, 3]. Objective: Aim of this study is to describe medication errors and identify causes of medication errors in children and adolescents spontaneously reported to HALMED, in order to propose and implement appropriate risk minimisation measures.
Results: Out of cases in patients up to 18 years of age, cases included terms pertaining to SMQ: Medication errors Broad. Grouping of cases was observed for the following pharmaceutical formulations of the active substances: salbutamol nebuliser solution, paracetamol solution for infusion, valproate oral solution and syrup and cholecalciferol oral drops, solution.
Identified root causes for medication errors were the following: misinterpretation of prescribed dosage due to very small volume resulting in 10 times higher administered dose e. Review of root causes for medication errors led to implementation of further risk minimisation measures, namely notifications for healthcare professionals salbutamol and valproate , additional risk minimisation measures i.
Following implementation of risk minimisation measures, it is concluded there is a further need for evaluation or their effectiveness. Systematic review of medication errors in paediatric patients. The Annals of Pharmacotherapy. Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation. Res Social Adm Pharm. Introduction: Digital features such as videos and infographics are used to make scientific literature more understandable and accessible to a wider audience [1, 2].
Plain language summaries and graphical abstracts are fast becoming the norm in complementing scientific publications across disciplines, including pharmacovigilance. However, the use of video explainers is limited, and the usefulness of such features is not well known. Objective: To evaluate the effectiveness of an animated explainer video in communicating a statistical method in pharmacovigilance. Communication specialists and data scientists collaborated to create the video, focusing on identifying key elements of the method and how to best illustrate its application in a visual narrative.
A survey of 10 multiple choice and rating scale questions was used to assess comprehension, perceived effectiveness of communication, enjoyment, and desire to learn more.
Subsequently, responses were collected and analysed. Results: Fifty-four individuals from 30 countries participated in the survey. Additionally, most participants see Table 1 for detailed results found the video to be an enjoyable and helpful way to learn about vigiGroup; agreed that an animated explainer video could be a useful alternative to reading a scientific paper and an effective way to visualise scientific methods; and would like to see more scientific methods presented in this way.
Conclusion: The vigiGroup animated explainer video was effective in communicating cluster analysis of adverse event reports to an audience of both pharmacovigilance and non-pharmacovigilance professionals. Increasing the use of such videos, to complement scientific literature, could be an effective way of building knowledge of complex statistical methodology and scientific developments more broadly.
The power of storytelling and video: a visual rhetoric for science communication. Bredbenner K, Simon SM. Video abstracts and plain language summaries are more effective than graphical abstracts and published abstracts. PLoS One. Consensus clustering for case series identification and adverse event profiles in pharmacovigilance.
Artif Intell Med. Introduction: Data from ongoing open-label clinical studies are assessed for safety signals on a set cadence, complying with regulatory requirements. One challenge is the need to contextualize safety when individual subjects have different exposure times rolling enrollment. Such issues resolve at the end of the study. However, during the study, visualizations add considerable value to the multidisciplinary discussion of incoming safety data.
The tool produces a column x-axis for each subject with a height y-axis corresponding to exposed time. Subjects are grouped by exposure in open-label or completed studies , and AEs are displayed relative to start of exposure by symbols on each subject-column.
The entire population can be displayed, or the display can be limited to the patients with the event s of interest. This allows viewing of AEs in the context of total study population number of columns and total exposed time area of the graph as a whole , or to narrow the focus to affected patients.
Although the tool is capable of calculating AE incidence rates, its real value for the assessment of ongoing studies lies in the ability to display events and patient time in an adaptive and intuitive way that allows for meaningful discussion of safety data.
Conclusion: Interactive data visualizations can enhance internal risk communication and clinical decision-making during ongoing clinical trials. Introduction: In , European pregnancy prevention program for oral retinoids, i. Objective: To measure the impact of the RMMs on utilization patterns of oral retinoids, alternative medications, contraceptives, and on rates of pregnancies occurring concurrently with retinoid prescriptions. Common analysis scripts were implemented by study sites.
An interrupted time series analysis was performed to assess immediate changes after the implementation level change and over time trend change. Results: The study population comprised 11,, females of childbearing age 12—55 years , 88, persons used an oral retinoid at any point during the study period. Monthly incidence and prevalence rates showed that retinoid prescriptions have a strong seasonal pattern with peaks of use in winter months. The low level of recording of pregnancy tests did not allow for trend analysis.
Pregnancy rates varied between 0. Conclusion: Based on the findings, there is very limited measurable impact of the RMMs among females of childbearing age in the included databases.
Moreover, pregnancies still happen during oral retinoid treatment after the implementation. Updated measures for pregnancy prevention during retinoid use. Compliance with pregnancy prevention programmes of isotretinoin in Europe: a systematic review. Br J Dermatol. Isotretinoin exposure during pregnancy: a population-based study in the Netherlands.
BMJ Open ;4:e Clin Pharmacol Ther. Introduction: During the recent covid vaccination campaign, the number of ICSRs reported by patients and professionals has dramatically increased, reaching up to almost 1 M declarations only in Europe EMA numbers. Before the covid pandemic, this system was successful in detecting ADRs from the patient reports declared through the French web national reporting system 1, 2.
However, how it behaves in conditions of higher reporting flow rate is unknown at present. The encoding of regional pharmacovigilance centers was employed as the reference ground truth to train the algorithm in a supervised manner. Moreover, a panel of three pharmacologists, with significant experience in ADRs encoding, was set-up to perform a case-by-case analysis of hundreds reports for which the algorithm provided improper encoding. Results: Overall, Of this, Because the percentage of newly reported ADRs increased over time and was higher for vaccine than not-vaccine related reports, we split the training and validation sets in batches with similar ADRs distribution.
Performance evaluation is currently under process. Initial feedbacks from the analysis performed by the experts are showing an uneven distribution of false positive and false negative across samples.
Results from the other experts are needed to confirm this finding. Conclusion: The core findings of this study will be gathered in the forthcoming weeks and be ready for the ISoP meeting in September.
This work will provide new insights about the effectiveness of deploying AI as a support to treat real world data in a context of sanitary crisis. Validation of an artificial intelligence pipeline to support the automatic coding of patient adverse drug reaction reports, using nationwide pharmacovigilance data. Drug Safety.
Introduction: The analysis of spontaneous reporting systems aims to identify potential adverse drug reactions in a timely and cost-effective manner. For their apparent simplicity, disproportionality analyses assessing the disproportionate presence of single drug-adverse event associations in spontaneous reports are rapidly expanding as a source of safety evidence complementary to clinical trials. However, the world and spontaneous reports is more complex than that: events occur in syndromes, drugs are taken in polytherapy, and patients are mosaics of multiple comorbidities.
Network science is one of the most promising approaches to tackle such complexity. Objective: To investigate the applications and promises of network science to spontaneous reporting data.
Methods: We identified four key examples to highlight the potentiality of network approaches to pharmacosurveillance: multiple drug intake in suicidal attempts, iatrogenic syndromes i.
Entities e. We used co-reporting frequencies to describe cooccurrence patterns for example, polytherapy and iatrogenic syndromes. We used marginal and partial correlations to investigate the associations between entities and their direction: for example, to identify biases and secondary adverse events. We used multilevel algorithms to identify clusters of interest, and network measures to identify trends of co-reporting. Results: The multiple drug intake network showed paracetamol at the center, as a drug of choice both alone and in combinations, and common combinations separated by therapeutic area, plausibly because of availability The Covid adversome identified a cluster of drug-induced hepatic injury and arrhythmia, and a disease-related cluster with Covid infection and respiratory conditions 1.
The immunotherapy adversome identified not only the known overlap syndrome cooccurrence of myocarditis, myasthenia, and myositis , but also another cluster with hepatitis, colitis and thyroiditis. Finally, investigating reactions to oxycodone, we observed that the reporting of crime and psychosocial reactions was secondary to the reporting of drug dependence. Conclusion: Networks allow to visualize and compare individual relations, identify clusters, and gather insights into the direction of correlation e.
Networks can complement traditional descriptive and disproportionality analyses characterizing the complexity of spontaneous reporting data. Frontiers in Pharmacology. Introduction: The spontaneous reporting system SRS has proven to be a cornerstone in the early and cost-effective detection of adverse drug reactions ADRs [].
Electronic Health Records EHRs are relatively untapped sources of real-world information that can be used in order to facilitate signal detection in pharmacovigilance PV. However, utilizing the EHR for PV involves a number of critical challenges including the efficient extraction of valuable pieces of information from unstructured bulk of free-text. Objective: To explore whether targeted searches in structured and unstructured fields in EHRs can be used as a method to detect possible cases in addition to spontaneous reports to strenghten a potential safety signal.
Suspected ADRs refer to potential signals based on the analysis of spontaneous reports with insufficient evidence insight into a possible relationship between the ADR and the drug. Per potential signal, a search with a validated text-mining software tool Ctcue was performed via combined queries on both structured and unstructured data [4].
In order to perform the process of case detection systematically, a step-by step search plan was developed and applied to each signal based on:. Results: The search retrieved 27 cases with flucloxacillin induced hypokalemia. After five confirmed cases via manual validation, no further validation was performed for the established ADRs. For each suspected ADR potential signal , one validated case was detected. Conclusion: A targeted search on structured and unstructured fields in EHRs using text-mining can be used as a method to detect additional cases next to spontaneous reports for a potential safety signal.
It is recommend to implement this as a complementary method in the current pharmacovigilance system. Evaluation of FDA safety-related drug label changes in Pharmacoepidemiol Drug Saf ;22 3 — A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee. Drug Saf ;37 12 — Raine J. Risk management: a European Regulatory view. Clinical pharmacology and therapeutics, 3 , — Research has proven that when patients are admitted to hospital, there are often changes to medication regimens 2, 3.
Further research is necessary to establish if pharmacists’ interventions on ensuring safety during patients’ healthcare journey from hospital admission to discharge, differs between MDS using patients and non-MDS using patients. Objective: The aim of this study was to analyse hospital pharmacists’ interventions for patients’ healthcare journeys for MDS using and non-MDS using patients. The study took place over four months from 1st July to 31st October There were initially admission episodes included in the study, and for each adult patient their healthcare journey from hospital admission to discharge was analysed for interventions and workforce input.
Interventions were ranked using the validated Eadon Scale 4. Results: A total of patients’ healthcare journeys were analysed. Patients whom did not have complete healthcare journeys from hospital admission to discharge were excluded. These patients had either died, had been transferred to another hospital, or were still inpatients when the study ended. There were Of the total MDS using patient journeys, Of the total non-MDS using patient journeys, Conclusion: This study has identified that the use of MDS increase the burden to pharmacist workforce input.
It is evident from the findings, that interventions may be needed for the majority of MDS using patients. It has highlighted that more significant interventions, Eadon Scale 5, are more prevalent for MDS using patients in comparison to non-MDS using patients. Relationship of in-hospital medication modifications of elderly patients to postdischarge medications, adherence, and mortality.
Ann Pharmacother. Drug changes at the interface between primary and secondary care. Int J Clin Pharmacol Ther. Eadon H. Assessing the quality of ward pharmacists’ intervention. International Journal of Pharmacy Practice. Validation of a hospital clinical pharmacy workforce calculator: a methodology for pharmacy? International Journal of Clinical Practice.
Introduction: Hypertension is a serious disease that occurs when blood pressure is persistently elevated over time 1. During the COVID vaccination campaign, several reports of hypertension occurred in plausible temporal relationship with immunization have been reported. Data have been extract on May 8th, All other reports have been defined as non-cases.
All reports in which the suspected causative agent was a COVID vaccine were used as index reports and all other reports as reference. A meta-analysis of observational studies that includes , individuals reported 13, events of blood pressure abnormal or increased 2. These events have been often described as short periods of hypertensive response and often observed in patients with risk factors. Conclusion: Our results confirmed a signal of risk of events of elevated blood pressure following immunization with COVID vaccines.
However, there is no evidence that these episodes could result in serious complication typically associated with hypertension, such as stroke, aneurysms, heart failure, myocardial infarction and chronic kidney disease. Introduction: Intravitreal drugs such as bevacizumab, ranibizumab, and aflibercept are widely used to treat a wide range of retinal diseases. Several studies suggest that repeated injections of these drugs may lead to a sustained rising of intraocular pressure increasing risk for glaucoma.
To date, a comparative safety study of these three drugs with respect to the incidence of glaucoma diagnosis has not been done. Objective: The objective of this study was to evaluate the risk of glaucoma diagnosis compared among new users of bevacizumab, ranibizumab, and aflibercept in Tuscany. Methods: A retrospective cohort study using the Tuscan regional administrative database was conducted.
Subjects with a first intravitreal injection index date between January —June were identified and followed to the first occurrence of glaucoma diagnosis.
Patients with less than a five-year look-back period, those with less than one year of follow-up, and those with previous use of intravitreal dexamethasone, diagnosis of diabetes or glaucoma were excluded.
We also excluded patients for whom we could not track the first injection to bevacizumab, ranibizumab or aflibercept. Glaucoma diagnosis was identified from exemptions, diagnosis in hospital discharge records or drug dispensations.
An intention-to-treat analysis was conducted to analyze risk of glaucoma diagnosis between the three drugs. A Cox model was constructed to compute hazard ratios adjusting for age, sex comorbidities, corticosteroid use and binocularity. The risk of incident glaucoma diagnosis compared to aflibercept was significantly higher among non-anticoagulant users who had received ranibizumab HR 2.
Among anticoagulant users no statistically significant difference was observed. Moreover, we found an increase in the risk of glaucoma with ranibizumab and bevacizumab compared to aflibercept among non-anticoagulant users. A time dependent exposure analysis is ongoing to confirm these results.
Introduction: A method of time-to-onset TTO signal detection for screening unexpected temporal patterns from vaccine spontaneous report data has been published in [1]. Due to the large number of spontaneous reports associated to covid vaccines, highly significant TTO signals could be detected whereas there are no clinically relevant unexpected temporal patterns. Methods: The revised method used only the most predictive measure [3] of the two Kolmogorov-Smirnov KS tests originally designed: the p-value of the KS test of the TTO distribution of a given event post a given vaccine against the TTO distribution of the same event post other vaccines.
A threshold on the Kolmogorov-Smirnov distance, that can have values between 0 and for no difference between time-to-onset distributions and 1 for extreme differences—was set at 0. A threshold on the p-value of the KS test was set at 0.
The Vaccine Adverse Event Reporting System was prospectively frozen every week of the first quarter and the revised TTO signal detection method was prospectively applied on the two covid vaccines. The performance in detecting events that were posteriori determined as causally related to the exposure of the covid vaccines, namely Pericarditis and Myocarditis, was retrospectively assessed.
Conclusion: The revised TTO method allowed early detection of unexpected TTO patterns post exposure to covid vaccines by controlling both the level of significance and the magnitude of difference between the TTO distributions in a context of mass vaccination where individual case review is challenging. Van Holle L et al. Using time-to-onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof-of-concept study, PDS 21 6 , — Use of logistic regression to combine two causality criteria for signal detection in vaccine spontaneous report data, Drug Safety 37 12 , — With the fast-tracked development and concurrent introduction of vaccines in all countries, there is a need for equitable safety surveillance to monitor adverse events following immunization AEFIs in high-income and low- and middle-income countries LMICs.
Reports from females made up The highest number of reports came from persons 18—44 years. Sputnik V contributed the highest percentage of AEs per vaccine for Africa. Headache, pyrexia, injection site pain, dizziness, and chills were the top 5 reported AEs for Africa and RoW. Qualitative findings revealed decisions of many funding organizations to fund safety surveillance in LMICs were influenced by considerations about country priorities, the perceived utility of the evidence generated for local decision making, and the contributions to global health by safety surveillance systems.
Funding decisions by donor organizations were influenced by country priorities and the perceived value added by data generated from safety surveillance systems in LMICs to local and global decision making. Coronavirus Vaccine Tracker. The New York Times [Internet]. Introduction: Therapeutic advances have reduced morbidity and mortality, but have led to an increase in adverse drug events ADE.
This is a case-control type study, with the original information from the administrative data from the hospital information system of the public health system in Brazil-SIH-SUS, in the period from to After applying the exclusion criteria, , hospital admissions associated with at least one ADE were included in the study.
The proportion of patients with ADE in hospitalizations was 0. Drug poisoning and drug abuse are the adverse event classes most associated with increased risk of death. This study, confirm that the SIH-SUS is a robust source of data for the field of pharmacovigilance, enabling the identification of risk factors for death and facilitating the monitoring of ADEs in the hospital environment.
Mortality among patients due to adverse drug reactions that occur following hospitalisation: a meta-analysis. Prospective identification versus administrative coding of adverse drug reaction-related hospitalizations in the elderly: A comparative analysis.
Pharmacoepidemiol Drug Saf. Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study. Stausberg J, Hasford J. Drug-related admissions and hospital-acquired adverse drug events in Germany: a longitudinal analysis from to of ICDcoded routine data.
Introduction: Transplant recipients are chronically ill patients, who require lifelong drug therapies to prevent reject and graft loss. To date, there is no consensus on the optimal immunosuppressive strategy []. Objective: The aim of the study was to assess the effectiveness and safety of maintenance immunosuppressive drug therapies in kidney transplant. Methods: A retrospective multicentre observational study, involving 4 Italian regions, was conducted based on the national transplant Information system and regional healthcare claims data.
Specifically, the regional analytical datasets regarding incident patients underwent to kidney transplant in the years —19 were created using an open-source tool for distributed analysis. Results: Overall, 3, kidney recipients were considered, of which During a median follow-up period of 4. Among safety outcomes, serious infections had the highest incidence 9.
Conclusion: In clinical practice, a significantly better benefit profile has been demonstrated for kidney recipients treated with TAC compared to CsA. In particular, the combination of TAC and mTOR appears to be the optimal strategy reducing the incidence of severe infections.
Our findings on long term risk-benefit profile of immunosuppressive therapy may be helpful to define the optimal drug therapy in kidney recipients. Comparison of tacrolimus and cyclosporine for immunosuppression after renal transplantation: An updated systematic review and meta-analysis. Saudi J Kidney Dis Transpl. Target of rapamycin inhibitors TOR-I; sirolimus and everolimus for primary immunosuppression in kidney transplant recipients.
Cochrane Database Syst Rev. Timing of mTORI usage and outcomes in kidney transplant recipients. Int J Med Sci. Published Jan 9.
Due to the small sample size of pivotal trials in pediatrics, real-world evidence on the safety of those vaccines in the pediatric population is urgently required. Objective: i To investigate the safety of COVID vaccines by measuring frequencies of solicited and serious adverse events following immunization AEFIs with the first and the second doses of vaccines through active surveillance and, ii to compare the results with the published clinicaltrials in children and adolescents.
Of them, only Overall, Conclusion: This study confirmed safety profile of COVID vaccines in the pediatric population as already documented in the pivotal trials, with a high frequency of local solicited adverse events and an extremely low rate of serious adverse events.
Introduction: Advances in the treatment of cancer in young patients have led to great improvements in life expectancy. However, treatment with chemo or radiotherapy causes reduction of sperm counts often to azoospermic levels that may persist for several years or be permanent. Oligospermia or azoospermia and long-lasting testicular atrophy are common adverse consequences of cancer treatment 1.
Cases of oligospermia and azoospermia were identified using MedDRA v No Dis-Rep was found for any of the 14 AA TKIs: acalabrutinib, axitinib, cabozantinib, dacomitinib, lenvatinib, neratinib, nintedanib, pazopanib, ponatinib, regorafenib, sorafenib, sunitinib, tivozanib and vandetanib.
The analysis in VigiBase database yielded similar results. Our results however, should be interpreted with caution as disproportionality analyses are hypothesis generating rather than hypothesis testing. Meistrich, M. Clinical drug investigation. Bate A, Evans S. Quantitative signal detection using spontaneous ADR reporting. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Skin lightening products contain high concentrations of harmful ingredients such as hydroquinone, mercurials, and corticosteroids, and are reported to cause serious complications such as hyperpigmentation, exogenous ochronosis, wound dehiscence, nephropathy, steroid addiction syndrome, predisposition to infections, and other endocrinologic complications.
Despite all these public health risks, they have been used in many countries without regulation and consultation of healthcare professionals 3. Similarly, in Eritrea, there is uncontrolled marketing and use of SLAs even those with banned harmful ingredients. Objective: This study was conducted to assess the perception and utilization of SLAs among females of Asmara, the capital city of Eritrea.
Methods: A cross-sectional descriptive study was conducted in representative samples of all beauty salons available in Asmara between May and July The study participants were selected using two-stage stratified cluster sampling technique.
The data collected through face-to-face interview was entered and analyzed using CSPro 7. Results: The study enrolled females. The majority of the respondents agreed that SLAs can make someone white About two-third Of those who ever used SLAs, About half of the respondents With the use of SLAs, Employed females AOR: 1.
Conclusion: Utilization of SLAs among females was prevalent. They were satisfied with its use despite experiencing adverse effects which urges coordinated efforts in tightening the regulation of cosmetics in general and establishment of cosmetovigilance systems in particular. Widespread use of toxic skin lightening compounds: medical and psychosocial aspects.
Dermatologic Clinics, Afr Health Sci. The global prevalence and correlates of skin bleaching: a meta-analysis and meta-regression analysis. Int J Dermatol. Introduction: Drug therapy in paediatrics is often associated with uncertainties due to lack of data from clinical trials.
Due to this off-label use, missing paediatric dosage forms and complex dose calculations, medication errors ME occur up to three times more frequently compared to adults [3]. Objective: The aim of the study was to investigate the nature, characteristics and preventability of drug-related hospital admissions in paediatrics. If parents had given consent for data transfer and further analysis, the suspected ADRs resp.
MEs were subsequently validated by a blinded, independent expert team [6]. All ADRs and MEs were assessed with regard to their nature, preventability, severity and drug association. Results: Of Consent for further analysis was obtained for 9. Allergic conditions, seizures incl. Treatment noncompliance, accidental exposure to product and dosing problems mainly underdosing were primarily identified as MEs in connection with the use of antiepileptic drugs, insulins and analogues and other beta-lactam-antibacterials.
Conclusion: Drug-related hospital admissions play a significant role in paediatrics. Moreover, almost half of them are considered preventable and therefore result in unnecessary harm and treatment costs. Dosing databases, training, and systematic screening for ADRs and MEs have great potential to increase the safety of drug therapy in children.
Kimland, E. Odlind, Off-label drug use in pediatric patients. Clin Pharmacol Ther, Magalhaes, J. Eur J Clin Pharmacol, Kaushal, R. JAMA, Smyth, R. PLoS One, Gallagher, R. Schulze, C. J Patient Saf, The lack of staff trained in PV is one of the most serious limiting factors affecting the development of PV in resource-constrained settings.
Previous experiences suggest that blending learning programmes can be implemented in resource-limited countries to train health care professionals HCP with remarkable gains in terms of knowledge acquisition. Methods: We developed the blended-courses integrated with a Train of Trainers scheme [1]. Two e-learning courses were made available on a web-based application, together with a manual on how to combine the e-learning courses together with face-to-face interactions. The blended course were given in Tanzania, Eswatini and Nigeria.
Results: In the three countries 95 participants were trained Table 1. All participants completed the two courses and the mean score of the post-test was significantly greater than on the pre-test Table 1.
In the second level, the participants from the first training were training others. The majority of respondents to questionnaires have been satisfied, declared they felt more involved in PV and reported at least an ADR after the training both in the first and second level.
The trends of reporting increased in the twelve months after the training if compared to the previous twelve months: vs and vs ICSRs were reported to Vigibase for Tanzania and Eswatini National Agency respectively. Conclusion: Our results demonstrated that a blended course can reach an important number of participants and improve their knowledge.
It is difficult to establish how much of the increase of reports was attributed to the blended learning training. Alammary A. Blended learning models for introductory programming courses: a systematic review. Plos one. The views and opinions of authors expressed herein do not necessarily state or reflect those of EDCTP. Introduction: Considering data from the literature in favor of active educational intervention to teach pharmacovigilance, we describe an innovative model of distance learning clinical reasoning sessions CRS of pharmacovigilance with 3rd year medical French students.
Objective: The three main objectives were to identify the elements necessary for the diagnosis of an adverse drug reaction, report an adverse drug reaction and perform drug causality assessment. Methods: The training was organized in 3 stages. Huizenga et al. In other previous studies [ [35] , [36] , [37] ], 20—30 min of experimental preparation time was also adopted.
Therefore, this study was conducted on these basis to ensure that the subjects were in thermal equilibrium and had not just entered the library. The filling time of each questionnaire last 3—4 min. The fluctuation range of temperature and humidity in the library were small. Thus, the measurement and field survey were reasonable.
The testing subjects were presented in Fig. The average age of the subjects was They were wearing short sleeved T-shirts 0. The average total clothing insulation Icl was 0. A written, self-completed questionnaire, consisting of two parts, was used to survey the participants. The second part investigated whether students wore masks, whether they experienced any symptoms of discomfort, and assessed the duration of wearing masks.
According to the ISO guidelines [ 41 ], test instruments described in Section 2. In many indoor thermal comfort studies [ [42] , [43] , [44] , [45] , [46] ], the height of the instrument were chose at the level of 1. When the human body is sitting still, the height of the head or face is about 1. These parts can be in direct contact with the environment for heat exchange. The sensitivity of the head and face is relatively strong [ [47] , [48] , [49] , [50] , [51] , [52] ].
Thus, in this field survey, the height of the instrument was set at level of 1. A standard globe thermometer with a diameter D of 0. The mean radiant temperature T mrt was calculated using Eq.
Instruments used to measure the air temperature T a , relative humidity RH , globe temperature T g , air velocity V a. Healthy subjects were selected to ensure the validity of the data, and incomplete questionnaires were excluded. Linear regression and logistic regression were used to analyze the relationship between the environmental parameters and the responses to the subjective questionnaire. The observations of the measured indoor thermal parameters T a , RH , V a , and T mrt measured are summarized in Table 4.
The minimum RH of the air in the library reached The distribution of environmental parameters in the library is shown in Fig. T op in the library was mostly Owing to the influence of solar radiation, the fifth floor of the library showed the highest temperature.
The proportion of indoor V a less than 0. Distribution of indoor environmental parameters in the library: a T op ; b RH ; and c V a. Among the questionnaires collected, questionnaires of subjects who wore masks were included. Among them, The voting distribution for discomfort regarding each body part is shown in Fig.
The proportion of facial discomfort was the largest The proportions of head and chest discomfort were Wearing masks for a long time may cause headache, dyspnea, and other symptoms; therefore, the proportions of discomfort due to these two symptoms would increase over time. Some subjects who wore masks for a long time experienced rapid heartbeat 9.
Percentages of participants who voted that they experienced discomfort in various body parts. A greater proportion of subjects with masks preferred a higher air velocity than that of subjects without wearing masks. Additionally, the more than half subjects preferred reduced the operative temperature to improve thermal comfort, specially the subjects with masks.
Thus, effects of masks on thermal comfort are significant. The demands of air velocity and operative temperature was different between wearing masks and without wearing masks. In addition, most subjects opined that the humidity level was acceptable. The primary reason is that the subjects has strong adaptive ability in high relative humidity in South China [ [54] , [55] , [56] ]. Therefore, in order to improve the thermal comfort in an air-conditioned room, the operative temperature needs to be lower with higher air velocity.
Distribution of percent thermal preference for environmental parameters with or without masks. The overall and local TSV results showed that wearing masks has a certain impact on human thermal sensation Fig.
The proportion of subjects wearing masks who reported TSV greater than zero was approximately 6. Considering individual parts of the body, the most obvious change in the TSV was in the face, where the percentage of subjects wearing masks and reporting a TSV greater than zero increased by approximately The proportion of subjects who wore masks and reported a TSV greater than zero for the head and chest were 6.
Further, the proportion of subjects who wore masks and reported a TSV greater than zero for the back and limbs was small. Wearing masks can affect the breathing frequency and inspiratory capacity, thereby resulting in heat accumulation on the face, and an overall feeling of excessive heat.
Percentage distribution and normal distribution curve of thermal sensation votes in the library: a Whole; b Face; c Head; d Back; e Chest; and f Limbs. No difference was observed between those with and without masks in their voting on the feeling of heat and wind on the back, chest, and limbs. The most obvious differences between the subjects who wore and did not wear masks were in their reporting about the face and head. For the whole body MTSV, similar differences were observed between the subjects who wore and did not wear masks.
These correlations were calculated based on thermal sensation voting. The results were reasonable. The small p-value indicates that there is a significant difference between them, which indicates that there is a significant difference between wearing masks and not wearing masks in the whole thermal sensation and some local thermal sensation.
Most subjects always feel acceptable in whole body thermal sensation. In addition, the comfort temperature was determined by the whole body thermal sensation. Thus, the difference of comfort temperature between masks and no masks were not significant. However, from Figs. Therefore, it is very necessary to control environmental parameters for human local thermal sensation and whole body thermal sensation. The probability curves are shown in Fig.
The preferred T op of the subjects without masks was Many previous investigations also found that the neutral temperature was higher than the preferred temperature [ 25 , [55] , [56] , [57] , [58] , [59] ]. However, in some previous investigations, the preferred temperature is equal to or higher than the neutral temperature [ 60 , 61 ].
For example, Tewari et al. Zheng et al. In addition, some previous investigations show that the regression method were used to analyze the subjects’ behavioral adaptation [ [62] , [63] , [64] ].
In hot summer and warm zoom, human have strong adaptability of hot thermal environment. In air-conditioned indoor thermal environment, the set temperature always lower than nature ventilation condition. The subjects were trained in cooler indoor thermal environment. Thus, the neutral comfort temperature was lower than preferred temperature.
As shown in Table 5 , the zone of acceptable T op according to PD was Contrastingly, the acceptable temperature zone obtained by PD was In addition, wearing a mask shifted the acceptable temperature and comfort temperature zones to a lower temperature. The longer the duration for wearing masks, the wetter the face will be, thereby reducing the comfort of the human body. Wearing masks while traveling, and in work and study places has become a daily part of people’s lives [ 65 ].
The discomfort accompanied by wearing masks has also attracted attention [ [66] , [67] , [68] ]. In the study or work place, wearing a mask for a long time may lead to a certain degree of physical symptoms. While wearing masks, people need a more comfortable environment to reduce the thermal discomfort caused by masks.
Subsequently, people often remove their masks to alleviate their discomfort, which reduces work efficiency [ 68 , 69 ]. The inner layer of a mask that has been worn for a long time gets wet because of condensation of the water vapor generated by breathing and sweat evaporation [ 16 , 68 ]. People usually do not change masks regularly, and continue wearing the same mask for a long time, which affects both hygiene and comfort. This study found that people who wore masks preferred increased air velocity, especially to alleviate the discomfort on the head and face.
The mask, which is in direct contact with the head and face, not only hinders the evaporation and heat dissipation from the head and face but also breathing, which explains the large proportion of chest discomfort. Therefore, fever and redness on the face and dyspnea were the most prevalent symptoms that were reported after wearing a mask for a long time. According to Fig. To analyze whether the regression equations of MTSV and T op obtained in this study were adaptive, we compared the results of this study with those of previous studies.
Table 6 summarizes the relationship between the MTSV and the thermal indices in summer. Different regression equations were obtained in different places, and the calculated neutral temperatures were also different.
In summer, for Guangdong, the neutral temperature of Guangzhou [ 56 , 70 ] differed from that of Shenzhen [ 55 ]. The neutral temperature in Shenzhen was The acceptable temperature range was In this study, the acceptable temperature range was This difference could be possibly because prefabricated site offices are mainly used for construction workers, and their heat resistance is greater than that of people working in regular offices [ 44 , 54 , 55 , [72] , [73] , [74] ].
A study in Shenzhen reported that as people wear more layers of clothes when the ambient temperature is low, which increases their thermal resistance, they adapt to a large temperature range [ 55 ]. Further, wearing masks lowered the neutral temperature value, and the acceptable and comfort temperature ranges shifted to the left. Therefore, the influence of humidity on thermal sensation was not analyzed in this study. In addition, the instrument for measuring environmental parameters was placed at a height 1.
We suggest that when filling in the questionnaire, the subjects only consider that the factor causing their discomfort is wearing masks.
Of course, the causes of discomfort also include air quality and environmental parameters, which need to be considered in big data research and need to be paid attention to in future research.
Therefore, we could only make a general comparison based on the existing voting data to analyze the sensitivity of each body part to the thermal environment in the study area. Additionally, we only analyzed the comfort of the Operative temperature as a whole without masks and with masks.
In addition, subjects of different genders also have an impact on the value of thermal indicators [ 75 ]. In this experiment, female subjects are about twice as much as male subjects, so the neutral temperature and comfort temperature may be biased towards female needs.
In the summer of , a field test and a questionnaire survey were conducted in a university library in Guangzhou, China. By analyzing the perceived thermal sensations and the thermal index of each parameter under the different environmental conditions for subjects with and without masks, the following results were obtained:.
Tianwei Tang: Writing — original draft, Methodology, Data curation. Yongcheng Zhu: Formal analysis, Data curation. Zhisheng Guo: Investigation. Yudong Mao: Investigation. Huilin Jiang: Resources.
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors express gratitude to all the subjects who participated in the survey. Build Environ. Published online Feb Author information Article notes Copyright and License information Disclaimer. All rights reserved.
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Literature review Personal medical masks typically consist of three layers with a melt-blown microfiber filter between two layers of spunbond fabric. Research objective In this investigation, the subjects were the students in Guangzhou University library, which is a public place with a high population density.
Determine the impact of wearing masks on the personal comfort of students in Guangzhou University Library. Establish different thermal comfort models under the conditions of wearing masks and not wearing masks.