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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 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.

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.

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.

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:.

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.

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.

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.

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.

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.

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.

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. It neither use any training dataset nor uses any pre-trained model. The proposed approach can effectively segment the radiological images that are collected from different patients i. It is to be clarified that this approach cannot take any decision about the type of disease automatically.

For example, the proposed approach cannot automatically differentiate between COVID related lung images and other lung diseases. This approach aims to help physicians in early and quick interpretation of the radiological images and diagnosis of the diseases without any manual delineations. This article proposes a novel, simple and elegant solution that uses some of the important features of the chest CT scan images to screen the COVID suspected patients easily and at an early phase which can be considered as an effective tool to reduce the drastic spread of this virus.

From Fig. Both qualitative and quantitative study produces some satisfactory results which help to make the proposed approach trustworthy so that it can be reliably adapted in the real-world scenarios. The proposed approach initially performs a superpixel-based clustering using the proposed superpixel computation method which significantly reduces the computational overhead for the further clustering process by reducing a large amount of spatial information.

The proposed work neither claims that the suggested approach is cent percent accurate in determining the COVID infection nor claims that it can be a replacement of the RT-PCR test but, the proposed method can help detect some common characteristics from the CT scan images, that can help to isolate some suspected patients from the rest of the community. The proposed approach is helpful for the early screening of the COVID besides being a significant contribution to the image segmentation literature.

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 would like to express their gratitude and thank the editors, anonymous reviewers, and referees for their valuable comments and suggestions which are helpful in further improvement of this research work.

The dedicated graphics memory is not utilized for any kind of processing purposes. The system in which the experiments are carried out is equipped with the Microsoft Windows 7 64 bit operating system. It is not at all essential to use the Matlab environment to implement the proposed approach.

We have chosen Matlab due to the availability of some inbuilt functions which are helpful to reduce the coding complexity. Still, any other languages or platforms can be used to implement the same. It is assumed that there are no manual annotations available and the proposed approach is capable to process the images without having any prior knowledge.

The final segmented images are constructed by assigning the superpixel to their corresponding cluster centers. These segmented images are helpful to interpret different features from these radiological images. Appl Soft Comput. Published online Feb 3. Author information Article notes Copyright and License information Disclaimer. All rights reserved. Elsevier hereby grants permission to make all its COVIDrelated research that is available on the COVID resource centre – including this research content – immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source.

Abstract Due to the absence of any specialized drugs, the novel coronavirus disease or COVID is one of the biggest threats to mankind Although the RT-PCR test is the gold standard to confirm the presence of this virus, some radiological investigations find some important features from the CT scans of the chest region, which are helpful to identify the suspected COVID patients.

Introduction Automated computer-aided systems prove their effectiveness and real-life applicability in various scenarios. Table 1 Some of the related literatures and their brief overview. The calibrated source-to-background curves are used to determine the volume using the iterative thresholding procedure. One major drawback of the system is that it cannot effectively measure small volumes.

Wiemker et. This work proposes a divergence theorem and histogram-based Ct image segmentation approach. This approach is can effectively and optimally isolate the lung nodules from the CT scan images.

In this context, the optimality is defined in terms of the mean gradient of the iso-surface and the sphericity. Asari et. This algorithm is consisting of two stages where the first stage employs a global thresholding approach and in the second phase, the differential region growing is used to extract the gastrointestinal lumen from the endoscopic images.

The dynamic hill-clustering approach is used to ascertain the effectiveness of the termination criteria and to look after the growth process. Yu-qian et. Traditional gradient-based edge detection approaches are susceptible to noise and therefore, this approach proposes a novel approach to detect edges of the lung CT scan images using mathematical morphology. This approach is tested on the CT images which are corrupted with the salt-and-pepper noise and its efficiency is proved by comparing this approach with some of the other standard approaches.

It is observed that this approach can efficiently reduce the effect of noise and also can generate precise edges. Falcao et. This approach is highly dependent on the user intervention to efficiently determine the segmented regions and to define the objects. This approach is found to be 3 to 15 times faster compared to manual tracing.

This approach can be applied almost independently to the applications. One main problem associated with this method is the difficulties associated with the choice of slabs and orthogonal slices which has a serious impact on the efficiency of this approach. Pan et. The proposed approach addresses the problem of discontinuous edges and dependency on the initialization which are associated with the traditional edge detection approaches.

In this work, the intensity of the gradient images is modeled as the concentration of the nutrients and the property of the bacteria Escherichia coli. The edges are highlighted as the paths of the bacteria. Although this approach performs well and comparative study shows the effectiveness of the proposed approach still, one problem of this approach is not very robust to noise. Noise can lead to crumpled edges. This approach is not also suitable to handle overlapped cells.

Ji et. Traditional fuzzy C-means clustering approach does not consider the spatial information and less robust to noise. This work proposes a modification which is known as the weighted image patch-based FCM. However, there is evidence for others tests and other clinical contexts monitoring tests [4] or management of critical results [5] the situation is very variable and sometimes worrying. The training of operators and the assessment of skills must therefore also concern, and with particular attention, the clinical significance of the results and the actions to be taken in the event of critical or unusual results.

Miller JA. Quality performance of laboratory testing in pharmacies: a collaborative evaluation. Clin Chem Lab Med ; Pract Lab Med ;e Medicina Kaunas. J Appl Lab Med 1; ISO and ISO enforce the implementation of dashboards, indicators, and patient risk management to continuously improve diagnostic outcome quality and TAT reduction. Our laboratory studied a year-old patients who underwent synthetic treatment or prosthetic surgery for femoral fractures within 48 h of admission and had symptoms attributable to ischemic heart disease dyspnea, chest pain, arrhythmia, and hypotension.

Troponin dosage was measured in all these patients with third-party POCT quality controls; these controls were validated by dedicated software to reduce analytical variability and allow monitoring of high-risk patients directly in TIPO by cardiologists with protocol 0—1 h; this also allowed the laboratory to measure, assess and reduce the risk of harm to the patient by IQCP system Individualized Quality Control Plan and monitoring integrated software as guidelines means to guarantee and protect above all the physician and the patient.

Yet, healthcare spending is unsustainable in an aging world. Technology, as every tool, brings its risks. Global levels of assistance are outrageously unequal. Mental disorders are exponentially growing. How will the lab of the future adapt to the entire story? Internet of Things will be the main key to acquire all the right data. Artificial Intelligence will be non-optional. With health-related knowledge doubling in months, AI will become a mandatory survival kit.

Yet, it still will see things that human eye might miss. Or making correlations that are simply too difficult anyway else. Yes, it will be both defensive for professionals and offensive to diseases, if used in the right way, as every tool.

Digital will influence behaviors, create communities, and redefine the patient-professional interaction. Patients are individuals, parents, children, workers, citizens, consumers, with ever-growing expectations on what and how can be done through a smartphone.

Space and satellite technology will provide the communication background for all above, from remote surgery to distributed expert network, etc. But Space will also bring additional data coming from macroscopic data gathering, earth observation, context-related data and gravity-less phenomenon analysis. Can the lab of the future stay immune from all above? Hard to believe. While exact predictions are useless, some trends are clearly visible and point to the raise of a next-generation ubiquitous lab.

The complete blood count CBC is one of the most requested tests, routinely performed in the central laboratory LAB by large haematological analysers, useful to diagnose many diseases and manage urgent clinical decisions such as transfusion or administration of chemotherapy and antibiotics.

Hb remains the most common POCT in haematology, essential to exclude anaemia. There are two types of technology: small benchtop analysers and portable devices. The latter, some of which use disposable cartridges, do not require start-up procedures, maintenance and calibrations.

The latest generation of portable devices combines advanced digital technology with innovative technologies of viscoelastic focusing and microfluidics and techniques, such as digital microscopy and computer vision, using near infrared spectroscopy and the absorption of light at multiple wavelengths, obtaining CBC results unthinkable until a few years ago.

Poor finger prick technique can provide misleading results, it was proved that capillary samples significantly underestimate PLTs overestimating Hb and WBCs, but differences have not clinical relevance when the samples are collected according to standardized procedures. POCT devices can not differentiate normal cells from pathological ones e. As recommended by the guidelines, due to the inherent risk of preanalytical errors and the standard risk of error during analytical and postanalytical phases, threshold values must be established to repeat CBC in a LAB.

Literature suggests that POCTs are not yet the ideal tools to perform CBC for diagnostic purposes, but they are useful in urgent situations such as rapid monitoring of some parameters e. Further studies are needed to confirm the promising results of POCTs and evaluate their performance even at low ranges and in pathological conditions. Rampoldi E. Carraro P. Biochim Clin ; Briggs C. Where are we at with point-of-care testing in haematology?.

BJH ; — Mooney C. Point of care testing in general haematology. Machine learning algorithms have proven to be very effective in predicting the behavior of phenomena represented in biomedical data. The most commonly used machine learning algorithms, such as artificial neural networks, produce so-called “black box” results, namely: a complex set of mathematical equations that cannot be interpreted by people who do not have in-depth mathematical skills;.

When applying machine learning to data such as images, black box algorithms are not a problem, since the value of the model lies in its accuracy in detecting the presence of certain patterns, attributable, for example, to the presence of a tumor. A specific ML technique, the Rulex “rule generation method”, builds models described by a set of intelligible rules, thus allowing the extraction of important knowledge regarding the variables included in the analysis and their relationships with the outcomes of the phenomenon analyzed.

Introduction: Point-of-care testing POCT is laboratory testing conducted close to the site of patient care. POCT is growing in popularity with manufacturers offering a wide menu of tests and devices where the operator can obtain a rapid test result with the potential to initiate faster patient care decisions.

But POCT is not fool-proof, and any test can and will fail if operated under the wrong conditions. Methods: Risk management is a process where laboratories can assess their weaknesses, implement a control plan to detect and prevent erroneous results, and monitor the effectiveness of their plans. Results: The Clinical and Laboratory Standards Institute CLSI EPA: Quality Control Based on Risk Management provides guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.

The advantages of utilizing a risk management approach to controlling laboratory errors will be emphasized along with the efficiencies gained from conducting a risk assessment and implementing a quality control plan.

POC are tests conducted near the site of patient care, outside of the laboratory, usually performed by patients or clinical personnel not trained in laboratory medicine. POCT require small sample volumes, minimize pre-analytical errors, and reduce alterations of labile analytes.

However, when used appropriately, could improve the patients outcomes by providing faster results and earlier therapeutic strategies 2. Instead, its over or incorrected use could leads a patient risk and potential increase of healthcare costs. We assessed, through a systematic review of the recent scientific literature, the accuracy of the POCT on troponin, procalcitonin, C-reactive protein, parathyroid hormone, INR and d-dimer, and evaluate the impact of faster results on patient management.

So, it is important that the POCT practice is evidence-based looking for evidence of whether POCT confers any advantage in clinical decision making in different scenarios. In some settings, such as rural environment, a rapid availability of cardiac troponins or other analytes can help clinicians to rule out or rule in disease, without transfer patient in other center, avoiding unnecessary costs 3.

Likewise, in Emergency Department, availability of more rapid results with POCT help clinicians to refer patients, but does not always translate into shorter stays 4.

BMJ ; — Ann Clin Biochem. Arch Pathol Lab Med. Alter DN. Arterial and venous blood gas analysis reveals oxygenation and acid-base status of the body. Hemoximetry is recommended to determine the impact of dyshemoglobins on oxygenation. Some calculated values may be in error, e. Moreover, the presence of high concentration of fetal hemoglobin may also be a problem if blood gas analyzer does not detect it, as instrument assumes hemoglobin to be of the adult type, and therefore the calculated blood gas oxygen saturation values are underestimated.

In critically ill patients many other analytes have been used to estimate the severity of disease and try to prognosticate morbidity and mortality. No measurements can encompass the complexity of a disorder, but lactic acid can approach that goal 3 Indeed lactic acidosis is the most frequent metabolic acidosis and many causes are reported for lactate increase, not only hypoxia: the higher the lactate concentration, the worse the outcome.

Low protein concentration, resulting from dilution of blood with protein-free electrolyte solution during surgery, will result in erroneously low Ht value.

Acute respiratory distress syndrone: the berlin definition, Ranieri MV et al. Conductivity-based Hematocrit measurement during cardiopulmonary bypass. Steinfelder-Visccher J et al. The knowledge that has been garnered so far on severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 infection is that humoral immunity encompasses the generation of immunoglobulins of most classes against surface viral antigens, which mostly involve the spike protein, the nucleocapsid protein, but also envelope and membrane proteins.

Since the spike protein is the anchor that the virus uses for penetrating the host cells through biding with its natural host cells receptors, it can be assumed that antibodies binding to spike protein of SARS-CoV-2, and especially to its receptor binding domain, would retain stronger neutralizing potency against the virus. Serological testing has been conventionally defined as a diagnostic procedure used for detecting an immune response against an infectious agent.

The diagnostic sensitivity stratified according to the assay methodology is highly variable. Additionally important drawbacks of rapid serological tests include the facts that the information provided by the companies is concerning because often lacks details, its quality is considerably variegated among different devices, several claims are vague, there is a lack of transparency along with the fact that human aspects are not been adequately addressed for purpose of alleviating the risk of inappropriately using the device.

The risk of misinterpreting tests results by patients when rapid kits are used for self-diagnosis is another aspect that must be considered. This was mostly due to objective difficulties encountered by the patients in reading and interpreting the results of the strips. Important considerations for implementing point-of-care serology testing thus include i usage of well-validated tests, evaluated against a gold standard; ii performance characteristics – thus encompassing sensitivity, specificity, positive and negative predictive values or cross-reaction with other coronaviruses – shall be tested using serum samples collected from patients infected with SARS-CoV-2, with other respiratory viruses including seasonal coronaviruses and also from healthy controls; iii adequate training of healthcare workers is needed iv and, finally, IV provisions must be in place, encompassing the capture of testing data for individual patient records and surveillance purposes, and the participation to external quality assessment schemes, to systematically monitor the quality of this type of testing.

At the heart of society 4. It is in these sectors that, lately, the greatest investments have been made in digital transformation aimed at exploiting -through data-all the new present and emerging technologies, from the Internet of Things IoT to Artificial Intelligence AI.

The exploitation of Big Data, in fact, constitutes the starting point and the indispensable resource for the development of innovative and precision medicine, providing scientific, organizational and infrastructural support to promote research and accelerate preclinical and clinical studies.

However, this development, having increased the number of subjects holding health-related data, the speed of transmission of such data and the quantity of information electronically stored often not on national territory , has determined an exponential increase in the danger of data processing from the point of view of confidentiality and an increased possibility of damaging the dignity and fundamental freedoms of the individual.

This has led to an increased sensitivity of the European legislator and, subsequently, of the national legislator, towards the protection of such data and related protections. In addition to the General Data Protection Regulation, which has revolutionized the way of conceiving the data economy, it is, in fact, being evaluated by European institutions the first draft of the Artificial Intelligence Act, which will be the real springboard for the massive and regulated use of algorithms, especially in healthcare.

To be precise, this last mentioned regulation will only define the limits to the use of algorithmic systems already widely in use. AIFA, through this guide, has described some case studies, showing some workflows that represent the regulations impacted depending on the type of system used and paying particular attention to the compliance related to the treatment of data and the related profiles of cybersecurity.

Ad oggi sono operativi circa 72 Drive-Through-Difesa. I contributi, forniti da ciascuna Forza Armata, sono diretti e coordinati fin dalla prima ora dal Comando Operativo di vertice Interforze COI per mezzo di una Sala Operativa dedicata, composta da personale interforze.

In the last couple of decades, Laboratory Medicine has made giant steps forward in terms of innovative technology and has made major scientific breakthroughs in the medical field as a whole. Indeed, a plethora of both in vitro and in vivo assays and tests in biological fluids of the human hydrodynamic system are now available.

The importance, for clinical purposes, of novel metabolic processes and protein cross-talk mechanisms is being increasingly recognized. The increased survival period of sick, elderly people, plus the therapeutic aspects of precision medicine, in which the drugs selected resulted in a series of direct approaches to altered target molecules, have made it difficult to identify the most effective molecules to use as biomarkers in most of this population scenario.

Therefore, it seems that Laboratory Medicine does not need to increase further value in the contribution to the care of fragile individuals, and in people affected by chronic degenerative diseases. Notwithstanding all these premises, and the increase in Clinical Laboratory testing, which is, and will continue in the future to be an indispensable ally of medical care, the correct diagnosis of a single or of multiple diseases occurring in a single individual will benefit enormously from this Discipline, if some steps forward will be made.

I believe that the enormous amount of knowledge now accumulating in the field of Laboratory Medicine will revolutionize, not only the medical care of people, but, in the various areas of the medical scenario, also the field of Laboratory Medicine Science itself and the practice deriving from it.

In other words, we should all begin to be mindful of our state of health as early as about 20—25 years of age, when most auxological aspects have been reached, and sexual maturity completed. Therefore, also healthy people should be monitored as well as patients, which should be one of the tenets of preventive medicine. Having said that, I must now say that chronological age is practically meaningless in calculating health status. This, of course, applies much more to multimorbidity; in fact, once identified them, measures can be made to eradicate or to delay the start or the progression of each illness, therefore determining a better state of health during the progression of chronological age.

The revolution I am talking about is to look at each individual when they are enjoying still normal health, as mentioned above. This approach may be considered too costly, but in effect it is much less costly than waiting for the appearance of an overt disease, which must then be treated for decades, frequently with very expensive drugs and tests laboratory and imaging. This will also support the joining of Preventive Medicine to effective Individualized Medicine.

Salvatore F. The shift of the paradigm between ageing and diseases. Clin Chem. Lab Med. During the second wave, the validation of SARS-CoV-2 antigen rapid diagnostic tests RDT has substantially changed testing strategies globally, since results were available within 30 min, reducing turnaround time and therefore exposure risk.

Recently, validated self-tests for SARS-CoV-2 based on the nasopharyngeal swab NPS or saliva have prompted for the empowerment of the general population in the fight against the spread of infectious. Swabbing is a complex task requiring training and competency assessment, and thus they are performed by trained nurses or physicians. Recently, Tsang et al. The Authors concluded that saliva and nasal swabs are clinically acceptable alternatives to commonly used nasopharyngeal swabs.

Saliva is a matrix elective for self-collection, and molecular testing is reliable but require laboratory instrumentation to be performed. Indeed, antigen determination on salivary samples is still under debate [2]. Most of the errors occur in the preanalytical phase, with relatively few analytical and post-analytical errors. Some issues arising during the pre-analytical phase of SARS-CoV-2 diagnostics regards: the time of swab, swabbing practice, sample handling and conservation and RNA extraction.

NPS should be taken at the time of symptom onset when the highest viral load occurs in COVID, thus not the day immediately before and not too far from possible close contact with positive subjects.

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. Windows 10 1703 download iso italy covid vaccine/scheduling

Spillage of biological fluids 9. Traceability Levels of responsibility Clinical Chemistry and Hematology exam table with storage times. Commons Attribution (CC BY) license, which allows users to download, copy and build Figure 2 also shows, for small window sizes ranging from 10 to Italian Journal of Food Science, ; 33 (4): 1–10 Figure 1. The schematic illustration of the vaccination and treatment schedule of the experiment.❿

TELEMEDICINE AND HEMOSTASIS-THROMBOSIS CENTRES – Windows 10 1703 download iso italy covid vaccine/scheduling

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 [].

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.

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.

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.

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.

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.

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. 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.

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.

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.

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 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].

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.

It neither use any training dataset nor uses any pre-trained model. The proposed approach can effectively segment the radiological images that are collected from different patients i.

It is to be clarified that this approach cannot take any decision about the type of disease automatically. For example, the proposed approach cannot automatically differentiate between COVID related lung images and other lung diseases. This approach aims to help physicians in early and quick interpretation of the radiological images and diagnosis of the diseases without any manual delineations. This article proposes a novel, simple and elegant solution that uses some of the important features of the chest CT scan images to screen the COVID suspected patients easily and at an early phase which can be considered as an effective tool to reduce the drastic spread of this virus.

The proposed approach initially performs a superpixel-based clustering using the proposed superpixel computation method which significantly reduces the computational overhead for the further clustering process by reducing a large amount of spatial information.

Therefore, radiological images can be conveniently explicated with the application of the proposed method and the proposed approach is also helpful in the easy interpretation of the radiological images. Carta 1 , G. Bonetti 2. The self-monitoring of blood glucose is of utmost importance for diabetic patients: it allows patients to evaluate their individual response to the therapy and verify whether the glycemic objectives have been met.

All of this must of course be based on the use of one data which accurately reflects the glycemia. The guidelines recommend the use of a device for the self-measurement of glycemia POCT which passed the necessary tests of accuracy and precision and thus presents the CE mark. Some studies, however, have emphasized how a non-negligible number of devices bears the CE mark without actually meeting the minimum criteria of accuracy requested 1.

Even the Italian guidelines 2 highlight the necessity that producing firms clearly declare the analytical features of their devices, particularly in terms of accuracy and precision.

The hierarchy of the sources of information has the scientific studies of literature in the first place, with the declarations of producers only ranked second. Lacking explicit and comparable references or in the presence of diverging situations around the analytical performances, diabetic facilities may activate a local evaluation of themselves, with a periodic comparison of the accuracy of the devices being recommended anyway.

The evaluation of the accuracy of POCT systems is very discussed. In any case, the accuracy of glucometers is based on the comparison with a reference method, and it is thus necessary to utilize a correct reference method in laboratories. Much has been discussed around possible variables that may alter the quality of a comparative study of this type method used, type of capillary or venous sample, use of first or second drop for POCT measurement etc.

Traditionally, sodium fluoride NaF is used to stop the glycolysis; this, however, is unable to contrast the glycolysis during the first hour of conservation of the sample. The use of inhibitors that associate the NaF with the citrate buffer thus provoking an early inhibition of the glycolysis has proved more effective in that sense.

The use of early glycolysis inhibitors NaF plus citrate has proved effective to stabilize samples even up to 15 days and this may allow their use even as control material to evaluate the analytical performances of the glucometers alternatively to the materials currently employed which are based on serum or plasma with an addition of glucose and which may present commutability problems. Carta, M. Riv Ital Med Lab 10, — International Organization for Standardization.

In vitro diagnostic test systems-requirements for blood glucose monitoring systems for self testing in managing diabetes mellitus. ISO US Food and Drug Administration. How should glucose meters be evaluated for critical care. As with tests in central laboratories, decentralized analyzes show risks of error in the post-analytical phase. Trying to outline some elements of this problem, it is possible to identify at least three critical elements with different peculiarities, with respect to “centralized” analyzes validation, reporting and, last but not least, clinical interpretation of the result.

We can discuss these items with respect to at least three macro areas: the skills of the personnel dedicated to POCT analysis, the available technologies and methodologies, the standardization of procedures. The validation of the result is the decision to consider an analytical result “valid”, reliable, to make decisions.

Results from central laboratory are generally considered valid a priori. In the POCT setting, validation is responsibility of personnel performing the test, usually “non-laboratory” people who do not have the training that laboratory professionals do.

Validation of a result must also take into account at least the correctness of the pre-analytical and analytical phases, the devices functionality, as well as the verification of quality through the control systems. Controlling panic and delta check ranges adds further complexity. We can combat these risks of error with continuous training, such as in the pre-analytical and analytical phases; using updated technologies, which allow self-checks, warning systems, blocking of results in case of non-compliance with quality specifications, etc.

We are near the start of Artificial Intelligence and utilizing big data to prove competency of operators, to prove that meters were giving reliable results, close to the other meters in the hospital and to maintain quality control in devices used outside of the hospital and operated by nurses, emergency medical technicians, and others not laboratorians [1].

Numerous studies have shown that reporting can be a critical element, when the execution of the tests is very far from the control of the central laboratory. The incorrect laboratory report is the most relevant issue for the post-analytical POCT phase, and specific quality indicators specific quality indicators could be very useful or even mandatory soon [3].

Specific competence counts in the interpretation of the results. For some tests, such as blood gas tests or thromboelastometry, the skills of specialists who have POCT systems at their points of care are likely to be high, often the highest in the health care system. However, there is evidence for others tests and other clinical contexts monitoring tests [4] or management of critical results [5] the situation is very variable and sometimes worrying.

The training of operators and the assessment of skills must therefore also concern, and with particular attention, the clinical significance of the results and the actions to be taken in the event of critical or unusual results.

Our laboratory studied a year-old patients who underwent synthetic treatment or prosthetic surgery for femoral fractures within 48 h of admission and had symptoms attributable to ischemic heart disease dyspnea, chest pain, arrhythmia, and hypotension.

Healthcare is the one of the largest success stories of our times. Technology is another of the largest success stories of our times. We are in the middle of a health-tech secular change. This is for good. This is unstoppable. This is the best part of the story. Yet, healthcare spending is unsustainable in an aging world. Technology, as every tool, brings its risks. Global levels of assistance are outrageously unequal.

Mental disorders are exponentially growing. How will the lab of the future adapt to the entire story? Internet of Things will be the main key to acquire all the right data. Artificial Intelligence will be non-optional. With health-related knowledge doubling in months, AI will become a mandatory survival kit. Yet, it still will see things that human eye might miss.

Or making correlations that are simply too difficult anyway else. Yes, it will be both defensive for professionals and offensive to diseases, if used in the right way, as every tool. Digital will influence behaviors, create communities, and redefine the patient-professional interaction.

Patients are individuals, parents, children, workers, citizens, consumers, with ever-growing expectations on what and how can be done through a smartphone. Space and satellite technology will provide the communication background for all above, from remote surgery to distributed expert network, etc. But Space will also bring additional data coming from macroscopic data gathering, earth observation, context-related data and gravity-less phenomenon analysis. Can the lab of the future stay immune from all above?

Hard to believe. While exact predictions are useless, some trends are clearly visible and point to the raise of a next-generation ubiquitous lab. The complete blood count CBC is one of the most requested tests, routinely performed in the central laboratory LAB by large haematological analysers, useful to diagnose many diseases and manage urgent clinical decisions such as transfusion or administration of chemotherapy and antibiotics.

POCT devices can not differentiate normal cells from pathological ones e. As recommended by the guidelines, due to the inherent risk of preanalytical errors and the standard risk of error during analytical and postanalytical phases, threshold values must be established to repeat CBC in a LAB.

Rampoldi E. Carraro P. Biochim Clin ; Briggs C. Where are we at with point-of-care testing in haematology?. BJH ; — Mooney C. Point of care testing in general haematology.

Machine learning algorithms have proven to be very effective in predicting the behavior of phenomena represented in biomedical data. The most commonly used machine learning algorithms, such as artificial neural networks, produce so-called “black box” results, namely: a complex set of mathematical equations that cannot be interpreted by people who do not have in-depth mathematical skills;.

Results: The Clinical and Laboratory Standards Institute CLSI EPA: Quality Control Based on Risk Management provides guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.

Discussion: This presentation will describe how laboratories can partner with manufacturers to conduct risk assessments and implement quality control plans in their laboratory and at the point-of-care. The advantages of utilizing a risk management approach to controlling laboratory errors will be emphasized along with the efficiencies gained from conducting a risk assessment and implementing a quality control plan.

A revision of CLSI EPA is currently being drafted, and this presentation will preview a few of the updates that can be expected in the next version of the guidance document. Evidence based laboratory medicine EBLM focuses on the use of diagnostic tests to improve patient outcomes. POC are tests conducted near the site of patient care, outside of the laboratory, usually performed by patients or clinical personnel not trained in laboratory medicine.

POCT require small sample volumes, minimize pre-analytical errors, and reduce alterations of labile analytes. However, when used appropriately, could improve the patients outcomes by providing faster results and earlier therapeutic strategies 2. Instead, its over or incorrected use could leads a patient risk and potential increase of healthcare costs. We assessed, through a systematic review of the recent scientific literature, the accuracy of the POCT on troponin, procalcitonin, C-reactive protein, parathyroid hormone, INR and d-dimer, and evaluate the impact of faster results on patient management.

Instead, studies on CRP claimed a significant reduction of antibiotic prescription. Several authors evaluated troponin and INR reporting faster decision-making without any improvement in clinical outcome. Faster results are often translated in better outcomes, without evidence to support this conclusion. So, it is important that the POCT practice is evidence-based looking for evidence of whether POCT confers any advantage in clinical decision making in different scenarios.

In some settings, such as rural environment, a rapid availability of cardiac troponins or other analytes can help clinicians to rule out or rule in disease, without transfer patient in other center, avoiding unnecessary costs 3. Likewise, in Emergency Department, availability of more rapid results with POCT help clinicians to refer patients, but does not always translate into shorter stays 4.

The satisfactory analytical performance, together with an excellent practicability, suggest that the POCT represents an important technological advance in patient care, but, the lack of evidence about the patients outcome invite healthcare workers to use it with judgement. Price CP. Point of care testing. BMJ ; — Ann Clin Biochem. Arch Pathol Lab Med. Alter DN. Arterial and venous blood gas analysis reveals oxygenation and acid-base status of the body. Hemoximetry is recommended to determine the impact of dyshemoglobins on oxygenation.

Some calculated values may be in error, e. Moreover, the presence of high concentration of fetal hemoglobin may also be a problem if blood gas analyzer does not detect it, as instrument assumes hemoglobin to be of the adult type, and therefore the calculated blood gas oxygen saturation values are underestimated.

The initial values have a prognostic significance, but serial measurements are more valuable for prognosis. Conductivity-based Hematocrit Ht estimations have limitations. Abnormal protein concentration will change plasma conductivity. Low protein concentration, resulting from dilution of blood with protein-free electrolyte solution during surgery, will result in erroneously low Ht value.

In any situation, to correctly interpret BGA results history should be always considered: reasons for presentation, information concerning events, environment, trauma, medications, poisons, toxins and an accurate physical examination should be carefully collected. Acute respiratory distress syndrone: the berlin definition, Ranieri MV et al. Conductivity-based Hematocrit measurement during cardiopulmonary bypass.

Steinfelder-Visccher J et al. The knowledge that has been garnered so far on severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 infection is that humoral immunity encompasses the generation of immunoglobulins of most classes against surface viral antigens, which mostly involve the spike protein, the nucleocapsid protein, but also envelope and membrane proteins.

Serological testing has been conventionally defined as a diagnostic procedure used for detecting an immune response against an infectious agent. The diagnostic sensitivity stratified according to the assay methodology is highly variable. Additionally important drawbacks of rapid serological tests include the facts that the information provided by the companies is concerning because often lacks details, its quality is considerably variegated among different devices, several claims are vague, there is a lack of transparency along with the fact that human aspects are not been adequately addressed for purpose of alleviating the risk of inappropriately using the device.

The risk of misinterpreting tests results by patients when rapid kits are used for self-diagnosis is another aspect that must be considered.

This was mostly due to objective difficulties encountered by the patients in reading and interpreting the results of the strips. Important considerations for implementing point-of-care serology testing thus include i usage of well-validated tests, evaluated against a gold standard; ii performance characteristics – thus encompassing sensitivity, specificity, positive and negative predictive values or cross-reaction with other coronaviruses – shall be tested using serum samples collected from patients infected with SARS-CoV-2, with other respiratory viruses including seasonal coronaviruses and also from healthy controls; iii adequate training of healthcare workers is needed iv and, finally, IV provisions must be in place, encompassing the capture of testing data for individual patient records and surveillance purposes, and the participation to external quality assessment schemes, to systematically monitor the quality of this type of testing.

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