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The #COVID19 Government Measures Dataset puts together all the measures implemented by governments worldwide in response to the Coronavirus pandemic. The main symptoms of COVID are fever, fatigue, and dry cough, accompanied by nasal congestion, runny nose, and diarrhea in some patients [7]. COVID medicine is a new and fast-changing field. The editors and authors of replace.me have made every effort to provide information. And now for something completely different: from nCoV and COVID to nMan single cytokine or chemokine in COPD Better understand-. The coronavirus disease (Covid) causes. Download file PDF Removed (eSIR) model to predict epidemics trends in Italy and.❿
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Windows 10 1703 download iso italy covid symptoms covid.Investigation of the effects of face masks on thermal comfort in Guangzhou, China – PMC
Most subjects always feel acceptable in whole body thermal sensation. In addition, the comfort temperature was determined by the whole body thermal sensation. Thus, the difference of comfort temperature between masks and no masks were not significant. However, from Figs. Therefore, it is very necessary to control environmental parameters for human local thermal sensation and whole body thermal sensation.
The probability curves are shown in Fig. The preferred T op of the subjects without masks was Many previous investigations also found that the neutral temperature was higher than the preferred temperature [ 25 , [55] , [56] , [57] , [58] , [59] ].
However, in some previous investigations, the preferred temperature is equal to or higher than the neutral temperature [ 60 , 61 ]. For example, Tewari et al. Zheng et al. In addition, some previous investigations show that the regression method were used to analyze the subjects’ behavioral adaptation [ [62] , [63] , [64] ]. In hot summer and warm zoom, human have strong adaptability of hot thermal environment. In air-conditioned indoor thermal environment, the set temperature always lower than nature ventilation condition.
The subjects were trained in cooler indoor thermal environment. Thus, the neutral comfort temperature was lower than preferred temperature. As shown in Table 5 , the zone of acceptable T op according to PD was Contrastingly, the acceptable temperature zone obtained by PD was In addition, wearing a mask shifted the acceptable temperature and comfort temperature zones to a lower temperature.
The longer the duration for wearing masks, the wetter the face will be, thereby reducing the comfort of the human body. Wearing masks while traveling, and in work and study places has become a daily part of people’s lives [ 65 ]. The discomfort accompanied by wearing masks has also attracted attention [ [66] , [67] , [68] ].
In the study or work place, wearing a mask for a long time may lead to a certain degree of physical symptoms. While wearing masks, people need a more comfortable environment to reduce the thermal discomfort caused by masks.
Subsequently, people often remove their masks to alleviate their discomfort, which reduces work efficiency [ 68 , 69 ]. The inner layer of a mask that has been worn for a long time gets wet because of condensation of the water vapor generated by breathing and sweat evaporation [ 16 , 68 ].
People usually do not change masks regularly, and continue wearing the same mask for a long time, which affects both hygiene and comfort. This study found that people who wore masks preferred increased air velocity, especially to alleviate the discomfort on the head and face. The mask, which is in direct contact with the head and face, not only hinders the evaporation and heat dissipation from the head and face but also breathing, which explains the large proportion of chest discomfort.
Therefore, fever and redness on the face and dyspnea were the most prevalent symptoms that were reported after wearing a mask for a long time. According to Fig. To analyze whether the regression equations of MTSV and T op obtained in this study were adaptive, we compared the results of this study with those of previous studies.
Table 6 summarizes the relationship between the MTSV and the thermal indices in summer. Different regression equations were obtained in different places, and the calculated neutral temperatures were also different.
In summer, for Guangdong, the neutral temperature of Guangzhou [ 56 , 70 ] differed from that of Shenzhen [ 55 ]. The neutral temperature in Shenzhen was The acceptable temperature range was In this study, the acceptable temperature range was This difference could be possibly because prefabricated site offices are mainly used for construction workers, and their heat resistance is greater than that of people working in regular offices [ 44 , 54 , 55 , [72] , [73] , [74] ].
A study in Shenzhen reported that as people wear more layers of clothes when the ambient temperature is low, which increases their thermal resistance, they adapt to a large temperature range [ 55 ]. Further, wearing masks lowered the neutral temperature value, and the acceptable and comfort temperature ranges shifted to the left.
Therefore, the influence of humidity on thermal sensation was not analyzed in this study. In addition, the instrument for measuring environmental parameters was placed at a height 1. We suggest that when filling in the questionnaire, the subjects only consider that the factor causing their discomfort is wearing masks.
Of course, the causes of discomfort also include air quality and environmental parameters, which need to be considered in big data research and need to be paid attention to in future research. Therefore, we could only make a general comparison based on the existing voting data to analyze the sensitivity of each body part to the thermal environment in the study area. Additionally, we only analyzed the comfort of the Operative temperature as a whole without masks and with masks.
In addition, subjects of different genders also have an impact on the value of thermal indicators [ 75 ]. In this experiment, female subjects are about twice as much as male subjects, so the neutral temperature and comfort temperature may be biased towards female needs. In the summer of , a field test and a questionnaire survey were conducted in a university library in Guangzhou, China. By analyzing the perceived thermal sensations and the thermal index of each parameter under the different environmental conditions for subjects with and without masks, the following results were obtained:.
Tianwei Tang: Writing — original draft, Methodology, Data curation. Yongcheng Zhu: Formal analysis, Data curation. Zhisheng Guo: Investigation. Yudong Mao: Investigation. Huilin Jiang: Resources. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors express gratitude to all the subjects who participated in the survey. Build Environ. Published online Feb Author information Article notes Copyright and License information Disclaimer.
All rights reserved. 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.
Literature review Personal medical masks typically consist of three layers with a melt-blown microfiber filter between two layers of spunbond fabric. Research objective In this investigation, the subjects were the students in Guangzhou University library, which is a public place with a high population density. Determine the impact of wearing masks on the personal comfort of students in Guangzhou University Library.
Establish different thermal comfort models under the conditions of wearing masks and not wearing masks. Methods The methods of this study are as follows.
Research environment The study was conducted in the Guangzhou University library Fig. Open in a separate window. Subjective survey and measurements A total of healthy college students males and females; detailed information is provided in Table 1 were randomly invited to participate in the survey. Table 1 Anthropometric data of subjects SD: standard deviation.
Table 2 Subjective vote scale. Table 3 Instruments used to measure the air temperature T a , relative humidity RH , globe temperature T g , air velocity V a. Data processing Healthy subjects were selected to ensure the validity of the data, and incomplete questionnaires were excluded. Results 3. Thermal parameters The observations of the measured indoor thermal parameters T a , RH , V a , and T mrt measured are summarized in Table 4.
Table 4 Indoor thermal parameters. Effect of wearing masks on human comfort Among the questionnaires collected, questionnaires of subjects who wore masks were included. Distribution of the percentage of symptoms among participants wearing masks. Effect of wearing mask on thermal preference Fig. Distribution of thermal sensation vote The overall and local TSV results showed that wearing masks has a certain impact on human thermal sensation Fig.
Box plot for a thermal sensation vote and b air movement sensation vote. Table 5 Unacceptable percentage of Operative temperature under different conditions. Discussion 4. Effect of wearing face masks on human thermal comfort Wearing masks while traveling, and in work and study places has become a daily part of people’s lives [ 65 ].
Adaptive analysis of the operative temperature To analyze whether the regression equations of MTSV and T op obtained in this study were adaptive, we compared the results of this study with those of previous studies. Table 6 Comparison of the TSV model with previous studies conducted in offices. Conclusions In the summer of , a field test and a questionnaire survey were conducted in a university library in Guangzhou, China. By analyzing the perceived thermal sensations and the thermal index of each parameter under the different environmental conditions for subjects with and without masks, the following results were obtained: 1.
The subjects wearing masks had higher requirements for environmental comfort, and the thermal discomfort in their face and head increased. Among the subjects who felt uncomfortable, For subjects without masks, the neutral T op was For subjects with masks, the neutral T op was For subjects without masks, the acceptable T op range was For subjects wearing masks, the acceptable T op ranged from In summary, the subjects who wore masks preferred colder temperatures. The difference in thermal comfort between those wearing masks and those not wearing masks is not very big.
However, wearing mask for a long time may cause discomfort. Considering the thermal comfort, it is recommended to wearing a mask for no more than 2 h. Declaration of competing interest 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.
References 1. Rodriguez-Morales A. Covid, an emerging coronavirus infection: current scenario and recent developments – an overview. Pure Appl. Chan J. A familial cluster of pneumonia associated with the novel coronavirus indicating person-to-person transmission: a study of a family cluster. Liu J. Community transmission of severe acute respiratory syndrome Coronavirus 2, Shenzhen, China, Morawska L. Xie Z. Total Environ. Bourouiba L.
Turbulent gas clouds and respiratory pathogen emissions: potential implications for reducing transmission of COVID Moore J. Oliver S. MMWR Morb. Zhang R. Wing S. Development of wearable air-conditioned mask for personal thermal management.
November ; Reader T. Google Patents; Lai A. Effectiveness of facemasks to reduce exposure hazards for airborne infections among general populations. Leung N. The data collected through face-to-face interview was entered and analyzed using CSPro 7. Results: The study enrolled females. The majority of the respondents agreed that SLAs can make someone white About two-third Of those who ever used SLAs, About half of the respondents With the use of SLAs, Employed females AOR: 1.
Conclusion: Utilization of SLAs among females was prevalent. They were satisfied with its use despite experiencing adverse effects which urges coordinated efforts in tightening the regulation of cosmetics in general and establishment of cosmetovigilance systems in particular. Widespread use of toxic skin lightening compounds: medical and psychosocial aspects. Dermatologic Clinics, Afr Health Sci. The global prevalence and correlates of skin bleaching: a meta-analysis and meta-regression analysis.
Int J Dermatol. Introduction: Drug therapy in paediatrics is often associated with uncertainties due to lack of data from clinical trials. Due to this off-label use, missing paediatric dosage forms and complex dose calculations, medication errors ME occur up to three times more frequently compared to adults [3].
Objective: The aim of the study was to investigate the nature, characteristics and preventability of drug-related hospital admissions in paediatrics. If parents had given consent for data transfer and further analysis, the suspected ADRs resp. MEs were subsequently validated by a blinded, independent expert team [6]. All ADRs and MEs were assessed with regard to their nature, preventability, severity and drug association.
Results: Of Consent for further analysis was obtained for 9. Allergic conditions, seizures incl. Treatment noncompliance, accidental exposure to product and dosing problems mainly underdosing were primarily identified as MEs in connection with the use of antiepileptic drugs, insulins and analogues and other beta-lactam-antibacterials.
Conclusion: Drug-related hospital admissions play a significant role in paediatrics. Moreover, almost half of them are considered preventable and therefore result in unnecessary harm and treatment costs.
Dosing databases, training, and systematic screening for ADRs and MEs have great potential to increase the safety of drug therapy in children. Kimland, E. Odlind, Off-label drug use in pediatric patients. Clin Pharmacol Ther, Magalhaes, J. Eur J Clin Pharmacol, Kaushal, R. JAMA, Smyth, R. PLoS One, Gallagher, R. Schulze, C. J Patient Saf, The lack of staff trained in PV is one of the most serious limiting factors affecting the development of PV in resource-constrained settings.
Previous experiences suggest that blending learning programmes can be implemented in resource-limited countries to train health care professionals HCP with remarkable gains in terms of knowledge acquisition. Methods: We developed the blended-courses integrated with a Train of Trainers scheme [1]. Two e-learning courses were made available on a web-based application, together with a manual on how to combine the e-learning courses together with face-to-face interactions.
The blended course were given in Tanzania, Eswatini and Nigeria. Results: In the three countries 95 participants were trained Table 1. All participants completed the two courses and the mean score of the post-test was significantly greater than on the pre-test Table 1.
In the second level, the participants from the first training were training others. The majority of respondents to questionnaires have been satisfied, declared they felt more involved in PV and reported at least an ADR after the training both in the first and second level.
The trends of reporting increased in the twelve months after the training if compared to the previous twelve months: vs and vs ICSRs were reported to Vigibase for Tanzania and Eswatini National Agency respectively. Conclusion: Our results demonstrated that a blended course can reach an important number of participants and improve their knowledge.
It is difficult to establish how much of the increase of reports was attributed to the blended learning training. Alammary A. Blended learning models for introductory programming courses: a systematic review. Plos one. The views and opinions of authors expressed herein do not necessarily state or reflect those of EDCTP.
Introduction: Considering data from the literature in favor of active educational intervention to teach pharmacovigilance, we describe an innovative model of distance learning clinical reasoning sessions CRS of pharmacovigilance with 3rd year medical French students.
Objective: The three main objectives were to identify the elements necessary for the diagnosis of an adverse drug reaction, report an adverse drug reaction and perform drug causality assessment. Methods: The training was organized in 3 stages. First, students practiced clinical reasoning CRS by conducting fictive pharmacovigilance telehealth consultations. Second, students wrote a medical letter summarizing the telehealth consultation and analyzing the drug causality assessment.
This letter was sent to the teacher for a graded evaluation. In the third stage was a debriefing course with all the students. Results: Of the third-year medical students enrolled in this course, participated in the distance learning CRS. The evaluation received feedback from students, with an average score of 8. The qualitative evaluation had only positive feedback. The students appreciated the different format of the teaching, with the possibility to be active. Conclusion: Through distance CRS of pharmacovigilance, medical students’ competences to identify and report adverse drug reactions were tested.
The students experienced the pharmacovigilance skills necessary to detect adverse drug reactions in a manner directly relevant to patient care.
The overall evaluation of the students is in favor of this type of method. Methods: This research used a qualitative inductive methodology through thematic analysis. The first step was to identify, through a literature review, current practices for herbal pharmacovigilance. Based on the findings a semi-structured interview guide was designed, and purposive sampling was used to recruit the interview participants. By using a snowballing technique more potential participants were reached.
Most of these recommendations are applicable worldwide, while some are limited to certain regions. Tong, A. Consolidated criteria for reporting qualitative research COREQ : a item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19 6 , — Introduction: Although medical cannabis MC has been available in Canada since , lack of recognition of MC as a drug has restricted patient access. The Quebec College of Physicians, between and , authorized MC use only within a research framework.
Follow-up ended due to either MC discontinuation, loss to follow-up, 3 years follow-up, or end of data collection May , 6 months after the last patient in. Data were collected at inclusion and at follow-up visits every 3 months for the first 2 years, then at least once per year in the third year.
MC mode of administration ingestion, inhalation, other , and cannabinoid content ratio tetrahydrocannabinol THC -dominant, cannabidiol CBD -dominant, or balanced were documented. Results: 2, patients were enrolled in the registry mean age Over follow-up, 3.
Reports included a total of AEs average 1. The most common PTs were dizziness Conclusion: There were no new safety concerns identified in the Registry, although notable differences in AE profile between modes of administration and cannabinoid content ratios should be considered by health professionals. Further work identifying and managing risk factors for AEs is warranted to maintain a favorable risk-benefit ratio for MC.
Introduction: Dengue is one of top ten global health threats and is a serious burden in the Philippines. Dengvaxia immunization program was launched on April for children 9—year-olds in three regions with high statistics of dengue, hospitalization, and deaths.
This was coincidentally the campaign period for national elections. Use of vaccine, once available, was part of a strategy to control epidemic. Current measures were inadequate. What started as vaccine-vigilance information sparked a public outcry. This led to a series of parliamentary investigations, traditional and social media misinformation and disinformation vilifying the health decision makers and the company, and criminal charges filed against over 20 individuals by the state over alleged unproven vaccine caused deaths.
Despite attempts to correct these narratives by a few health professionals, the damage to institution, the program, the product, and individuals have been done. The consequences of such actions of emotional approach without understanding the science have resulted in creating general vaccine rejection, hesitancy, other outbreaks such as measles, lowered confidence even with recent COVID vaccines.
Objective: This abstract aim to describe the situation at that time in the Philippines and extract lessons that will inform better risk communications during crisis. Results: Some of the important lessons learned are in risk management and communications. Adverse health product information should be announced with circumspect considering the level of health literacy and risk appreciation in a country. Partisan politics interfered with poorly understood science, fueled by imprudent comments by officials and health professionals who spoke out of turn, amplified by the media and created chaos.
The fear was so palpable that enlightened health professionals refused to provide countervailing facts. Reinstating the vaccine would be perceived as the government had back-pedaled on a mistake. In the meantime, the drama contributed to vaccination hesitancy and outbreaks.
Conclusion: Public health decisions are policy and regulatory decisions anchored in ethical and utilitarian principles. Edillo et al. Economic Cost and Burden of Dengue in the Philippines. Vannice, et al Mendoza, Dayrit, Valenzuela. Dengue researcher faces charges in vaccine fiasco. Lasco et. Medical populism and immunisation programmes: Illustrative examples and consequences for public health. Trolleyology and the Dengue Vaccine Dilemma. Dayrit, Mendoza, Valenzuela The importance of effective risk communication and transparency: lessons from the dengue vaccine controversy in the Philippines.
Dengue vaccination: a more balanced approach is needed. Introduction: Vaccines are vital tools to control epidemic and pandemic diseases, such as COVID, demonstrating safety and effectiveness. However, rare adverse events of special interest AESIs following vaccination arise with every new emerging pathogen vaccine program. Adversomics, a set of technologies that measure the inventory of molecules e. The International Network of Special Immunization Services INSIS brings together vaccine safety, public health, and systems biology experts in middle- and high-income countries to investigate the causes of, and identify strategies to mitigate AESIs following vaccination insisvaccine.
Brighton Collaboration case definitions and harmonized protocols will be employed to collect detailed clinical data and serial blood samples suitable for adversomics e. Integration of clinical and biological data will enable comparisons of analyte levels and immune responses within groups over time and between cases and controls. Global collaboration across five continents will ensure adequate sample size.
Conclusion: INSIS-led studies will provide insight into pathways triggered in these AESIs and susceptible populations to inform vaccine development strategies to reduce the potential to trigger pathways involved in AESIs, risk-benefit assessment, and personalized vaccination strategies. Introduction: During the covid 19 period, several countries needed to set up or develop their pharmacovigilance systems, unfortunately containment and the closure of borders prevented the organisation of classic training sessions.
Objective: The objective of this work is to present the pharmacovigilance simulation game developed by CAPM, RCC and the results of its pilot use with pharmacovigilants from 10 French-speaking African countries. The game is based on good practices in Pharmacovigilance PV , and inspired by the different WHO guidelines, the experience of the Moroccan PV center, and behaviors consensually considered as the norm in PV.
In fact, they are put in a real-life situation to choose actions and strategies for the development of a PV center and must be able to optimize the human and material resources at their disposal to make their center shine within their national health system but also at the level of the international PV network. Better understand the challenges and outlooks linked to the creation and management of a PV center. Put into practice the theoretical concepts in causality assessment, signal detection and risk minimization actions.
During the game, within 10 levels, participants have to set up a PV center following WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems as structural indicators, process indicators and outcome indicators, and following the pharmacovigilance process from collecting data, analyzing them, detecting signals, and setting up national technical pharmacovigilance committee to discuss about safety signals and risk minimization actions to put in place.
Conclusion: The use of the game by the pharmacovigilantes during the pilot phase gave good feedback on the ease of use and the effectiveness of the game in capacity building in pharmacovigilance. University of Huddersfield, Huddersfield, pp. Introduction: Pharmacovigilance has traditionally been a reactive science with a significant dependence on spontaneous adverse event reporting. The pandemic on the other hand has accelerated application of novel technologies and approaches to engaging with the patient, remote connected care at their home and dependence on technologies to supplement regular communication channels.
Telemedicine is evolving rapidly and playing a key role in clinical interventions. Objective: Digital Health and novel technologies offer a significant opportunity to enhance pharmacovigilance thru proactive patient monitoring, risk communication, personalized care plans and access to real world data.
Leveraging such approaches will not only lead to early detection of risks but also to personalized interventions and improved patient outcomes. Educational material which is more interactive, visual and multi-dimensional can replace paper or text based risk communication material.
This could provide early signal detection in individual patients and enable proactive patient level pharmacovigilance. Educational and risk related material can be dynamically updated based on patient preferences, interactions and profiles. Machine learning approaches which link material with outcome can enhance impact of pharmacovigilance methods and tools. In order to utilize the full potential of such options it is critical that the regulatory framework is updated to enable such approaches which complement traditional PV and can drive efficiencies and higher effectiveness in the risk communication process.
Collaboration within the network of industry and regulators is essential to further such research and maximize the impact on value for patients, HCPs and sponsors. Introduction: Large amounts of data associated with safety issues are generated along the entire lifetime of drugs, from its infancy as preclinical leads, through its adolescence as clinical candidates, all the way up to its adulthood as marketed drugs exposed to the human population.
Across the different stages in the life of a drug, some of the data collected initially may be confirmed and consolidated with data at an advanced stage, whereas other data may not be translated, and in some cases may even contradict, those safety signals that are ultimately observed in the human population.
Collecting and properly integrating such an heterogenous pool of data is a complex and tedious task. But even if one manages to put all data together, the construction of useful models to anticipate and detect drug safety signals remains a challenge.
Objective: The presentation will cover our efforts to connect data from in vitro safety pharmacology, preclinical toxicology, clinical safety and post-marketing spontaneous reports for over 9, small molecule drugs, combination drugs, and biologics.
A novel consensus approach using various statistical and machine learning methods to anticipate side effects of potential safety concern, detect adverse drug reaction signals and perform pharmacovigilance analyses will be introduced.
Use case application examples to individual drugs and drug classes will be discussed. Methods: Our consensus approach to post-marketing surveillance integrates four different methodologies based on detection of prior safety markers, identification of class reactions, statistical projection of disproportionalities based on reporting frequencies and velocities, and machine learning models of translational safety data.
Results: Results on the validation of our approach to anticipating adverse drug reactions of safety concern to the population at the postmarketing stage based on i in vitro safety pharmacology data, ii preclinical toxicology data, iii clinical safety data and iv the first sample of 25 postmarketing spontaneous reports will be presented.
Based on data available in each case, the performance of the different methods varies for different drugs, drug classes, and side effects. A discussion on performances in selected use cases will be included.
As an example, the analysis of long-term PARP inhibition on circadian patterns and its dependence on the reporting bias by consumers will be discussed. Conclusion: Integration and modelling of the large amount of translational safety data currently available from all phases of drug discovery, development and post-marketing to anticipate and follow adverse drug reactions opens an avenue to a whole new perspective in pharmacovigilance.
Introduction: Psychedelics are unique psychoactive chemicals that can change consciousness by acting on 5-HT2A receptors []. There is limited knowledge concerning the online interest in psychedelics that we can extrapolate via trends websites. Objective: We aim to examine the online information-seeking behavior concerning the most popular psychedelics, including cannabis—a quasi-psychedelic—in the European Union EU members of interest and the UK before and during the pandemic.
Methods: We designed a “dictionary” of terms to extract online search data from Google Trends concerning psychedelics and cannabis from Jan to 1-Jan We conducted a triple Holt-Winters exponential smoothing—additive model—for time series analysis to infer seasonality [4, 5]. We utilized hierarchical clustering—an unsupervised machine learning method—to explore clusters of countries concerning the spatial geographic mapping of these chemicals. We also implemented—a t-test—for comparing the slope difference of two trends before versus during the pandemic.
Results: There was an evident seasonal pattern for cannabis, NBOMe, and psilocybin in almost all nations of interest. Similar patterns existed in France and the UK, while those in Germany, Sweden, and Romania had relatively shorter periodicity. Analysis of slopes and hierarchical clustering conveyed differentiated patterns concerning the temporal and spatial mapping, respectively, while contrasting the two periods before versus during the pandemic.
Conclusion: Cannabis and psychedelics follow somewhat a consistent pattern concerning seasonality across Europe; some correlate with the seasonal harvesting of mushrooms, and others with public holidays, including Christmas, the new year holiday, or school breaks.
The pandemic influenced some significant changes concerning the online interest in the EU and the UK; nonetheless, we should rely on more rigorous longitudinal and experimental study designs—possessing a superior level of evidence—to confirm the causal relationship.
However, these patterns might be insightful for decision-makers and regulatory authorities—like the EMCDDA—to prognosticate and prevent addiction catastrophes. Understanding and using time series analyses in addiction research. Carhart-Harris RL. How do psychedelics work?. Current Opinion in Psychiatry. Novel psychoactive substances: types, mechanisms of action, and effects. British Medical Journal. Robust forecasting with exponential and Holt—Winters smoothing. Journal of Forecasting.
Gardner Jr ES. Exponential smoothing: The state of the art—Part II. International Journal of Forecasting. Introduction: Continuous monitoring of the safety profile of drugs is one of the critical processes of pharmacovigilance.
As medical literature might be valuable source of safety data, especially for rare, unlisted, serious cases, all MAHs are obliged to medical literature monitoring MLM in all marketing countries [1]. This approach can be changed through modern automation techniques. Objective: To develop and test a tool for automated monitoring of local literature and enhance drug safety data identification.
Methods: Modern programming approaches were used to create PV platform, intended for automated literature screening. GAMP 5 recommendations were used to prove the validation status. Results: We developed a tool—DrugCard PV platform which screens local medical sources for updates on a weekly basis. Till May we added around local journals originated from 10 countries that cover different therapeutic areas.
Our tool automatically searches for defined keywords drug trade names, active substances in published articles. Different file formats can be screened including text, pdfs, images etc. In case a new issue of a journal is published—a PV specialist will receive an email notification.
The mandatory features of a validated computerized system, like audit trail, logs, reports are also present here. Instead of manual reading of the whole journal issue the user only should read a separate article, analyze whether there is a valuable safety data and label it depending on the content.
PV specialists may work together inside the platform and provide a quality check for labeled articles. Our pilot study of how a new tool may improve the efficiency revealed interesting results. Despite the dramatically decreased amount of time needed, the number of identified ICRSs from literature increased. During the abovementioned pilot study of automated local literature monitoring lasting 2 months, 31 safety cases were identified valid and non-valid ICSRs.
This is much more than usual rate of safety cases finding. It offers increasing efficiency in safety information identification with less time spent on routine activities. Certificate of copyright in Ukraine. Hyperacute toxicity is a recent newly described entity, albeit incompletely characterized [3]. We selected reports with available information to calculate a plausible time-to-onset. Events of interest were classified into fulminant within 7 days and hyper-acute cases within 21 days, i.
Cases were described in terms of demographic and clinical features: age, gender, anticancer regimen combination vs monotherapy , therapeutic indications, seriousness hospitalization , case fatality rate CFR, namely the proportion of cases where death was reported as outcome , co-reported symptoms, co-reported irAEs. The Immune-Adversome was estimated considering events as nodes and co-reporting as links. Hyperacute cases 18, represented Monotherapy was reported in the majority of cases Pyrexia, diarrhea, fatigue, dyspnea were the most frequently reported symptoms.
Hyperacute myocarditis was reported in Among fulminant cases, most frequent irAEs were interstitial lung disease , colitis , hypothyroidism , and myocarditis Other co-occurring irAEs were colitis-hepatitis-thyroiditis, and arthritis and psoriasis.
Our network approach may complement traditional disproportionality analyses in pharmacovigilance for a more effective signal detection technique, thus supporting regulatory and clinical monitoring, especially in complex scenario such as oncology. Target Oncol ; — Oncologist ; — Hyperacute toxicity with combination ipilimumab and anti-PD1 immunotherapy. Eur J Cancer ; — Introduction: The prolongation of the QT interval is a serious and potentially fatal adverse reaction that has led to the discontinuation of many drugs including some opioids.
Data mining on pharmacovigilance databases can detect signals that identify early the risk associated with some drugs. Results: A total of drug-reaction pairs was found in opioid reports. Analysis of individual opioids show significant signals for QT prolongation for each drug. The temporal evolution of the different signals according to the number of reports included from to shows early significant positivization of signals in the first 6 to 12 months. Underlying mechanism is unknown, but it seems to be linked to hERG channel blocking.
We propose the evaluation of the trend of change in the confidence intervals of the disproportionality parameters as a measure that can predict the occurrence of clinical events at the population level and a posible usefull strategy to minimize adverse reactions. Introduction: Language and speech are increasingly debated as potential markers for diagnosing and monitoring patients with affective and psychotic disorders 1—3.
However, many neglected factors may confound communicative atypicalities. A comprehensive list of potential confounding drugs will support the design of robust communicative marker studies. Objective: We aim at identifying a list of drugs potentially associated with speech and language disorders, within psychotic and affective disorders. Within the FAERS, we considered separately 3 populations psychotic, affective and non-neuropsychiatric disorders , to account for the confounding role of different underlying conditions.
Robustness analyses were performed to account for the biases. Results: We identified a list of potential expected and 91 unexpected confounding medications for the identification of communication markers of affective and psychotic disorders e. We developed also a MedDRA query proposal for speech and language conditions, formalization of possible biases, and related analyses to account for them.
Conclusion: We provided a list of medications to be accounted for in future studies of communicative bio-behavioral markers in affective and psychotic disorders. The methodological procedure we developed does not simply facilitate future investigations of communicative biomarkers in other conditions, more crucially it provides a case-study in more rigorous procedures for digital phenotyping in general. Insel TR. Automated assessment of psychiatric disorders using speech: A systematic review.
Laryngoscope Investigative Otolaryngology. Voice patterns in schizophrenia: A systematic review and Bayesian meta-analysis. Schizophr Res. Introduction: The comparison of safety profiles for products recently on the market is difficult.
There is a lack of methodology for quantifying the potential differences between products that have the same indication. Objective: Provide the tools to quantify the differences in spontaneous reporting between two products. An Euclidian distance from the EBGM to the diagonal line measures the deviation from what would have been expected under the null assumption of similar safety profiles.
As the deviation does not capture the statistical uncertainty around the estimate, we propose as measure of the deviation the minimal distance of the four Euclidian distances calculated from each of the credibility intervals around the EBGM post Product A and Product B. A visualization capturing the global trend of the most substantial differences in reporting was generated.
Conclusion: This relatively simple method can provide quantification of the differences in reporting and could help prioritize one product over the other for some population subgroups.
Introduction: The application of text mining approaches to identify adverse events AEs from electronic health records EHRs is a growing area of interest in pharmacovigilance research.
In veterinary medicine, the majority of EHRs consist of unstructured clinical narratives, hence the development of appropriate methods for identifying AEs of interest is an important step in the research process. Identifying renal disease poses a specific challenge as the event may be described in narrative form or implied by reported test results or the use of renal disease specific medications. In this study we developed regular expressions regexes to identify relevant mentions of renal disease in veterinary free text clinical narratives.
Objective: To develop a method for identifying veterinary patients with renal disease in free text clinical narratives. Methods: Using VeDDRA terminology as a starting point, we used an iterative approach to develop a series of regexes which were then applied to a random sample of 10, clinical narratives.
In order to measure precision, clinical narratives containing a match to the regexes were reviewed against a case definition by two independent reviewers and disagreement was settled by consensus. Terms in the final regex were derived from three sources—VeDDRA, a word embedding model and expert opinion.
To determine recall, the final regex was applied to a sample of consults where the main presenting complaint was deemed to be renal disease by a veterinary clinician. Expanding this terminology using a word embedding model improved the PPV to 0.
Following changes suggested by a veterinary expert, the PPV of the final regex was improved to 0. When the regex was divided into three components, the PPV for these individual portions was mentions of renal disease 0. When compared against the veterinary clinician validated sample of renal disease consults recall was 0. Conclusion: The developed regex can be used to identify animals with renal disease, with mentions of renal disease treatment being the most specific indicator of clinical disease.
This method can be employed to filter potential cases of interest from large datasets for use in observational studies. Introduction: We use AI in our everyday lives probably without even realising it.
There are many discussions about the use of AI in PV and the potential innovation that it could bring but given the conservative nature of our business and having to work in a highly regulated environment, how can we build confidence to get us over that barrier.
Will having the regulators use the same AI make us more comfortable or will legislation be necessary to drive us forward? Objective: Explore why PV has lagged behind with AI technology that is commonplace in other parts of our lives and business.
Aspects of AI, such as machine learning, are used in areas such as early disease prediction, clinical diagnosis, outcome prediction and prognosis evaluation, personalized treatments, drug discovery, manufacturing, clinical trial research, and more. In our personal lives, services like Amazon and Google use AI to understand and target their customers and we accept that as normal. The objective of this presentation is to explore the reluctance of accepting AI in PV and how we can move towards overcoming those obstacles.
We will look at some real-life practical examples where AI in PV has worked and what it took to get there. Conclusion: We will show that the practical application of AI is achievable and has been achieved in the high volume environment of a regulatory authority.
Many of the AI features used by the RA, and the lessons learned from that project, can also be applied in industry, so why are we waiting? Introduction: Access to case narratives during signal assessment is crucial to provide a more complete picture of the cases [1], however patient confidentiality needs to be considered.
Sharing of narratives while preserving privacy requires de-identification—the removal or replacement of personal identifiers. Automating this task can help with increasing data load. To ensure patient confidentiality throughout the full pharmacovigilance process, the narratives should be de-identified early in the process.
Person names—one of the more common identifiers in case narratives—can lead to in- direct identification of patients but are challenging to recognise in free text. Objective: To develop and evaluate a method for automated de-identification of names in case narratives. Methods: We use an ensemble of BERT [2]—a state-of-the-art language model using deep-neural network—combined with hand-engineered rules for detecting names.
Our model is trained on i2b2 deidentification challenge data [3] combined with unprocessed data from the Yellow Card system[4] provided by the MHRA. Because names are rare in the Yellow Card data, the training dataset is prepared using active learning through an independent model. Model testing is done on a separate, manually annotated dataset.
Evaluation of the deidentification is guided by: 1 how often clinically relevant information is removed and 2 how identifiable the narratives that the model fails to completely de-identify are. We define three categories of identifiability: a Directly identifiable, where subject identification is very likely with the leaked information e. Results: Out of the 71 narratives with names and initials, only 12 contained occurrences missed by the system.
Manual evaluation found only one directly and one indirectly identifiable narrative due to leaks. It should be noted that the leaked direct identifier was a foreign, non-English name. A single narrative may contain multiple occurrences of names, the table presents results per occurrence. Conclusion: Automated de-identification of names is possible without compromising clinically relevant information. A rescue vessel practises saving people during a maritime search and rescue drill in the Pearl River estuary, south China’s Guangdong Province, on Oct.
A comprehensive maritime search and rescue drill was held Thursday in the Pearl River estuary, seeing the participation of 28 vessels, 3 aircraft, and around staff members. Wednesday as a tropical storm, according to the Guangdong Meteorological Service.
The typhoon is expected to move in a north-west direction at a speed of about 20 km per hour, before entering the Beibu Gulf Wednesday afternoon, with its intensity gradually weakening. The meteorological department predicted that there will be heavy wind and rain in Guangdong between Wednesday and Thursday morning. Schedules of several high-speed rail lines and flights in Guangdong have been temporarily adjusted, and customs clearance has been suspended at relevant ports.
Web editor: ZhongWenxing, LiangJun. While they were monitoring Group D of the Hainan gibbon troupe on Jan. This new family member now brings the population of the rare primate to 36 in total. The baby gibbon is currently in good condition. Photo shows a female gibbon and its newborn baby from Group D of the Hainan gibbon troupe. In early , two Hainan gibbons were also born, with one of them belonging to Group D of the local Gibbon population. Photo courtesy of the Hainan Tropical Rainforest National Park Administration Yuannan is the offspring of an older female gibbon in Group D of the troupe, while the most recently spotted baby gibbon is the offspring of a younger female gibbon in the same group.
Yuannan and this newborn baby gibbon are also half-siblings, with the same father but different mothers, said Qi Xuming from the publicity and science popularization department of the Bawangling Branch of the Hainan Tropical Rainforest National Park Administration.
Web editor: Hongyu, Bianji. Your email address will not be published. King Sihamoni conveyed his good wishes to Xi and warmly welcomed Li’s visit to Cambodia. Definitions of category. Leave a Comment Cancel reply Your email address will not be published.
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