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Hoboken, NJ: Wiley. Communications of the ACM361217— Retrieved November 5, We collected vaccine errors through the different notification sources used by the National Centre of Pharmacovigilance in Tunisia.❿

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Due to the absence of any specialized drug, it is very difficult to restrict the drastic spread of this virus. Apart from using various protective equipment, early detection and isolation can be very effective to combat the spread of this highly infectious virus.

In the middle of this pandemic scenario, some vaccines are invented and are being applied to the people and it is a ray of hope to fight against this virus. As per the report of the world health organization, ,, numbers of confirmed cases can be observed in countries and 4,, people are already expired due to this disease as of 15th October , pm CEST [40]. From these statistics, it is clear that the worldwide mortality rate is approximately 2.

The major risk factor lies in the highly infectious nature of this virus. Hopefully, 6,,, vaccine doses have already been administered worldwide which may be helpful in reducing the mortality rate.

Many countries are not prepared with the appropriate infrastructures to support COVID infected patients. Moreover, many people from remote areas are not even able to arrange protective gear like masks, sanitizers, etc.

The reverse transcription-polymerase chain reaction test i. It is a quite inspiring finding because CT scan images can be used to isolate some suspected patients at an early phase and therefore, the drastic spread of this virus can be stopped to some extent. The presence of some prominent features like ground-glass opacities, crazy paving, etc. Typically, the absence of properly annotated data makes the automated biomedical image analysis job difficult.

As the name suggests, the proposed approach is based on the superpixels and type 2 fuzzy systems where the type 2 fuzzy objective function is modified to incorporate the advantages of superpixels to efficiently process a large amount of spatial information.

The fuzzy objective function is optimized with the recently developed metaheuristic procedure i. The proposed method allows automated and efficient analysis of the CT scan images which is beneficial to enhance the computer-aided diagnostic systems to act as a tool against the COVID virus.

To summarize, the major contributions are as follows: 1 A novel superpixel-based image segmentation technique is proposed that reduces the incurred computational cost for processing a high amount of spatial information, 2 Type-II fuzzy system is incorporated with the superpixel-based approach, 3 A recently developed metaheuristic procedure ACSO is further enhanced, 4 The conventional fitness function of the FCM clustering approach is enhanced to exploit the advantages of superpixel 5 The cluster centers are updated with the help of the proposed fuzzy ACSO approach.

The remaining article is prepared in the following way: Sections 2 , 3 describes the artificial cell swarm optimization method and the type 2 fuzzy clustering framework respectively. Section 6 discusses some of the relevant points and a brief conclusion is presented in Section 7.

This is a recently developed metaheuristic procedure that is inspired by the artificial cell division procedure. 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. Retrieved May 2, Houston Chronicle. Hearst Corporation. Archived from the original on July 22, The Verge.

Vox Media. Retrieved May 26, Retrieved April 22, Retrieved April 7, Retrieved September 30, The Start menu is coming back to Windows”. Archived from the original on February 3, Retrieved March 31, The Slate Group. Seattle Times. Seattle Times Network. Archived from the original on September 30, Retrieved November 5, Ziff Davis. February 2, September 30, The Guardian.

Thomson Reuters. Business Insider. January 21, Retrieved January 24, PC Magazine. Ziff Davis Media. Conde Nast. Purch Inc. Archived from the original on March 2, Retrieved June 16, Archived from the original on April 9, Retrieved July 25, Retrieved July 17, Retrieved July 23, The New York Times.

July 13, Tom’s Guide. Retrieved August 12, Retrieved April 3, Retrieved May 16, Windows Blog. Retrieved March 9, Retrieved February 7, December 7, Retrieved December 8, Windows Experience Blog. PC Pro. July 29, April 23, Retrieved July 16, March 20, Microsoft says Hello to palm-vein biometrics”.

Retrieved February 10, March 17, Retrieved March 17, Retrieved July 18, Microsoft Docs. Retrieved October 30, Windows Developer Blog. June 17, Retrieved January 2, This means you can now use WSL for machine learning, artificial intelligence, and data science scenarios more easily when big data sets are involved. Scott Hanselman’s Blog. Windows PowerShell Blog. Archived from the original on April 2, Retrieved March 20, Retrieved January 23, Retrieved April 29, Retrieved March 25, June 15, Retrieved August 26, Retrieved January 9, Retrieved October 21, Retrieved October 22, Retrieved May 17, May 21, Retrieved May 22, August 11, Retrieved September 12, Archived from the original on August 11, Retrieved January 21, Xbox Blog.

February 13, Retrieved March 18, Retrieved February 14, Xbox Wire. May 14, Retrieved May 15, Archived from the original on December 1, Retrieved April 2, Retrieved November 15, MKV and.

FLAC files all on its own”. PC Games Hardware in German. May 5, Retrieved April 11, DirectX Developer Blog. Archived from the original on October 4, Retrieved October 3, October 3, March 21, Retrieved June 20, PC Perspective.

Archived from the original on September 5, Retrieved August 22, May 13, Retrieved May 13, Retrieved February 3, May 2, February 3, Retrieved March 11, April 21, Retrieved April 23, Retrieved March 8, Retrieved October 1, October June 21, Retrieved June 22, Conde Nast Digital.

June 22, Retrieved June 23, Retrieved June 21, Purch, Inc. Retrieved July 27, July 15, Retrieved July 15, Retrieved August 4, November 30, Redmond Magazine.

Retrieved August 6, Retrieved July 31, Supersite for Windows. Archived from the original on August 1, March 18, May 19, Retrieved May 21, Retrieved July 14, Retrieved May 18, Windows Help. Archived from the original on May 1, Retrieved February 1, May 16, While our free offer to upgrade to Windows 10 will not apply to Non-Genuine Windows devices.

March 19, Retrieved March 19, Retrieved August 13, July 31, Windows 10 blog. Microsoft Corporation. October 12, Retrieved October 12, Retrieved July 4, Network World. July 28, Retrieved July 29, Retrieved August 1, May 9, Retrieved November 3, Limitations and directions for further research Our research is focused on time pressure during a crisis acting on the involved entities and the coordination of a standard.

Acknowledgements The authors thank the editors and two anonymous reviewers for their insightful and valuable suggestions. Appendix A. In the beginning, were there any established standards or other solutions that you could build up on? How is Novid20 affected by standards and consortia? Can you describe positive or negative influences? More recently, major tech firms Apple and Google have entered the scene and are developing a reference solution.

How does this affect Novid20, and how was this news received within your organization? Appendix B. How did the various members and individuals involved come together? More recently, major tech firms Apple and Google have entered the scene and developed a reference solution. Notes 1 We follow earlier examples e.

Contributor Information Klaus Marhold, Email: ta. References Abbate, J. Business History Review , 75 , 1 , — Oxford: Oxford University Press. IEEE Access , 8 , — Work Study , 50 , 3 , 95— Organization Studies , 37 , 12 , — Journal of Cleaner Production , 94 , — Harlow: Pearson. Government Technology Agency. Applied Economics , 34 , 16 , — Telecommunications Policy , 35 , 4 , — Organization Studies , 33 , 5—6 , — Journal of Epidemiology and Community Health , 75 , 8 , — Hoboken, NJ: Wiley.

In: Coen, D. Journal of Medical Internet Research , 22 , 5 , e MIS Quarterly , 30 , — Science , , , In: Liu, K. Oxon: Routledge, pp. Business History Review , 66 , 1 , 51— Academy of Management Perspectives. Computer Science Review , 38 , Futures , 43 , 9 , — European Commission. Academy of Management Review , 14 , 4 , — Academy of Management Review , 16 , 3 , — In: Miller, J.

The American Economic Review , 76 , 5 , — Science , , eabb Research Policy , 30 , 4 , — Oxford Review of Economic Policy , 18 , 1 , 80— Research Policy , 43 , 3 , — Academy of Management Journal , 45 , 1 , — Journal of Electronic Imaging , 27 , 4 , 1— Singapore: Springer.

IEEE Network , 5 , 6 , 19— Electronic Markets , 30 , 1 , 87— The Lancet Global Health , 8 , 4 , e—e Administrative Science Quarterly , 35 , 1 , 9— Research Policy , 41 , 9 , — Technological Forecasting and Social Change , 91 , — International Journal of Health Geographics , 19 , 1 , 8. The American Economic Review , 75 , 3 , — Information Systems Research , 18 , 4 , — Management Science , 54 , 11 , — In: Dodgson, M.

Journal of Management Information Systems , 23 , 2 , 91— In: Akhgar, B. Nature Medicine , 27 , 5 , — In: Wright, J. Oxford: Elsevier. The Lancet Digital Health , 2 , 6 , e—e New York Times.

Retrieved from www. 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. First, students practiced clinical reasoning CRS by conducting fictive pharmacovigilance telehealth consultations. Second, students wrote a medical letter summarizing the telehealth consultation and analyzing the drug causality assessment. This letter was sent to the teacher for a graded evaluation. In the third stage was a debriefing course with all the students.

Results: Of the third-year medical students enrolled in this course, participated in the distance learning CRS. The evaluation received feedback from students, with an average score of 8. The qualitative evaluation had only positive feedback.

The students appreciated the different format of the teaching, with the possibility to be active. Conclusion: Through distance CRS of pharmacovigilance, medical students’ competences to identify and report adverse drug reactions were tested. The students experienced the pharmacovigilance skills necessary to detect adverse drug reactions in a manner directly relevant to patient care.

The overall evaluation of the students is in favor of this type of method. Methods: This research used a qualitative inductive methodology through thematic analysis. The first step was to identify, through a literature review, current practices for herbal pharmacovigilance. Based on the findings a semi-structured interview guide was designed, and purposive sampling was used to recruit the interview participants. By using a snowballing technique more potential participants were reached.

Most of these recommendations are applicable worldwide, while some are limited to certain regions. Tong, A. Consolidated criteria for reporting qualitative research COREQ : a item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19 6 , — Introduction: Although medical cannabis MC has been available in Canada since , lack of recognition of MC as a drug has restricted patient access.

The Quebec College of Physicians, between and , authorized MC use only within a research framework. Follow-up ended due to either MC discontinuation, loss to follow-up, 3 years follow-up, or end of data collection May , 6 months after the last patient in. Data were collected at inclusion and at follow-up visits every 3 months for the first 2 years, then at least once per year in the third year. MC mode of administration ingestion, inhalation, other , and cannabinoid content ratio tetrahydrocannabinol THC -dominant, cannabidiol CBD -dominant, or balanced were documented.

Results: 2, patients were enrolled in the registry mean age Over follow-up, 3. Reports included a total of AEs average 1. The most common PTs were dizziness Conclusion: There were no new safety concerns identified in the Registry, although notable differences in AE profile between modes of administration and cannabinoid content ratios should be considered by health professionals. Further work identifying and managing risk factors for AEs is warranted to maintain a favorable risk-benefit ratio for MC.

Introduction: Dengue is one of top ten global health threats and is a serious burden in the Philippines. Dengvaxia immunization program was launched on April for children 9—year-olds in three regions with high statistics of dengue, hospitalization, and deaths.

This was coincidentally the campaign period for national elections. Use of vaccine, once available, was part of a strategy to control epidemic. Current measures were inadequate. What started as vaccine-vigilance information sparked a public outcry. This led to a series of parliamentary investigations, traditional and social media misinformation and disinformation vilifying the health decision makers and the company, and criminal charges filed against over 20 individuals by the state over alleged unproven vaccine caused deaths.

Despite attempts to correct these narratives by a few health professionals, the damage to institution, the program, the product, and individuals have been done. The consequences of such actions of emotional approach without understanding the science have resulted in creating general vaccine rejection, hesitancy, other outbreaks such as measles, lowered confidence even with recent COVID vaccines. Objective: This abstract aim to describe the situation at that time in the Philippines and extract lessons that will inform better risk communications during crisis.

Results: Some of the important lessons learned are in risk management and communications. Adverse health product information should be announced with circumspect considering the level of health literacy and risk appreciation in a country. Partisan politics interfered with poorly understood science, fueled by imprudent comments by officials and health professionals who spoke out of turn, amplified by the media and created chaos.

The fear was so palpable that enlightened health professionals refused to provide countervailing facts. Reinstating the vaccine would be perceived as the government had back-pedaled on a mistake. In the meantime, the drama contributed to vaccination hesitancy and outbreaks. Conclusion: Public health decisions are policy and regulatory decisions anchored in ethical and utilitarian principles.

Edillo et al. Economic Cost and Burden of Dengue in the Philippines. Vannice, et al Mendoza, Dayrit, Valenzuela. Dengue researcher faces charges in vaccine fiasco. Lasco et. Medical populism and immunisation programmes: Illustrative examples and consequences for public health. Trolleyology and the Dengue Vaccine Dilemma. Dayrit, Mendoza, Valenzuela The importance of effective risk communication and transparency: lessons from the dengue vaccine controversy in the Philippines.

Dengue vaccination: a more balanced approach is needed. Introduction: Vaccines are vital tools to control epidemic and pandemic diseases, such as COVID, demonstrating safety and effectiveness. However, rare adverse events of special interest AESIs following vaccination arise with every new emerging pathogen vaccine program. Adversomics, a set of technologies that measure the inventory of molecules e. The International Network of Special Immunization Services INSIS brings together vaccine safety, public health, and systems biology experts in middle- and high-income countries to investigate the causes of, and identify strategies to mitigate AESIs following vaccination insisvaccine.


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February 1, The Slate Group. An interrupted time series analysis was performed to assess immediate changes after the implementation level change and over time trend change. Kim T. The unsupervised computer-aided systems are widely applied in different domains of research [8] , [9]. For more information, please visit www. Association was assessed using Bradford Hill criteria [5]. 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. J Patient Saf, June 10, ❿

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