Search results for: quadrangular space adverse events following immunization

Authors: Nashed Atef Nashed Farag

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Introduction: Reporting adverse events following vaccination remains a challenge. WHO has mandated pharmacovigilance centers around the world to submit Adverse Events Following Immunization (AEFI) reports from different countries to a large electronic database of adverse drug event data called Vigibase. Despite sufficient information about AEFIs on Vigibase, they are not available to the general public. However, the WHO has an alternative website called VigiAccess, an open-access website that serves as an archive for reported adverse reactions and AEFIs. The aim of the study was to establish a reporting model for a number of commonly used vaccines in the VigiAccess system. Methods: On February 5, 2018, VigiAccess comprehensively searched for ESSI reports on the measles vaccine, oral polio vaccine (OPV), yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine, and tuberculosis vaccine (BCG). These are reports from all pharmacovigilance centers around the world since they joined the WHO Drug Monitoring Program. Results: After an extensive search, VigiAccess found 9,062 AEFIs from the measles vaccine, 185,829 AEFIs from the OPV vaccine, 24,577 AEFIs from the yellow fever vaccine, 317,208 AEFIs from the pneumococcal vaccine, 73,513 AEFIs from the rotavirus vaccine, and 145,447 AEFIs from meningococcal cal vaccine, 22,781 EI FI vaccines against tetanus and 35,556 BCG vaccines against AEFI. Conclusion: The study found that among the eight vaccines examined, pneumococcal vaccines were associated with the highest number of AEFIs, while measles vaccines were associated with the fewest AEFIs.

Keywords: surgical approach, anatomical approach, decompression, axillary nerve, quadrangular space adverse events following immunization, cameroon, COVID-19 vaccines, nOPV, ODK vaccines, adverse reactions, VigiAccess, adverse event reporting

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Authors: Sundip Charmode, Simmi Mehra, Sudhir Kushwaha, Shalom Philip, Pratik Amrutiya, Ranjna Jangal

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Introduction: Quadrangular space syndrome involves compression of the axillary nerve and posterior circumflex humeral artery and its management in few cases, requires surgical decompression. The current study reviews the surgical approaches used in the decompression of neurovascular structures and presents our reflections and recommendations. Methods: Four human cadavers, in the Department of Anatomy were used for dissection of the Axillae and the Scapular region by the senior residents of the Department of Anatomy and Department of Orthopedics, who dissected quadrangular space in the eight upper limbs, using anterior and posterior surgical approaches. Observations: Posterior approach to identify the quadrangular space and secure its contents was recognized as the easier and much quicker method by both the Anatomy and Orthopedic residents, but it may result in increased postoperative morbidity. Whereas the anterior (Delto-pectoral) approach involves more skill but reduces postoperative morbidity. Conclusions: Anterior (Delto-pectoral) approach with suggested modifications can prove as an effective method in surgical decompression of quadrangular space syndrome. The authors suggest more cadaveric studies to facilitate anatomists and surgeons with the opportunities to practice and evaluate older and newer surgical approaches.

Keywords: surgical approach, anatomical approach, decompression, axillary nerve, quadrangular space

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Authors: Peter Yamoah, Frasia Oosthuizen

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Introduction: Reporting of Adverse Events Following Immunization continues to be a challenge. Pharmacovigilance centers throughout the world are mandated by the WHO to submit AEFI reports from various countries to a large pool of adverse drug reaction electronic database called Vigibase. Despite the relevant information of AEFI in Vigibase, it is unavailable to the general public. However, the WHO has an alternative website called VigiAccess which is an open access website serving as a repository of reported adverse drug reactions and AEFIs. The aim of the study was to ascertain the reporting pattern of a number of commonly used vaccines in VigiAccess. Methods: VigiAccess was thoroughly searched on the 5th of February 2018 for AEFI reports of measles vaccine, oral polio vaccine (OPV), yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine and tuberculosis (BCG) vaccine. These were reports from all pharmacovigilance centers in the world from the time they joined the WHO drug monitoring program. Results: After a thorough search in VigiAccess, there were 9,062 measles vaccine AEFIs, 185,829 OPV AEFIs, 24,577 yellow fever vaccine AEFIs, 317,208 pneumococcal vaccine AEFIs, 73,513 rotavirus vaccine AEFIs, 145,447 meningococcal vaccine AEFIs, 22,781 tetanus vaccine AEFIs and 35,556 BCG vaccine AEFIs. Conclusion: The study revealed that out of the eight vaccines studied, pneumococcal vaccines are associated with the highest number of AEFIs whilst measles vaccines were associated with the least AEFIs.

Keywords: vaccines, adverse reactions, VigiAccess, adverse event reporting

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Authors: Andreas Ateke Njoh, Shalom Tchokfe Ndoula, Amani Adidja, Germain Nguessan Menan, Annie Mengue, Eric Mboke, Hassan Ben Bachir, Sangwe Clovis Nchinjoh, Yauba Saidu, Laurent Cleenewerck De Kiev

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Vaccines serve a great deal in protecting the population globally. Vaccine products are subject to rigorous quality control and approval before use to ensure safety. Even if all actors take the required precautions, some people could still have adverse events following immunization (AEFI) caused by the vaccine composition or an error in its administration. AEFI underreporting is pronounced in low-income settings like Cameroon. The Country introduced electronic platforms to strengthen surveillance. With the introduction of many novel vaccines, like COVID-19 and the novel Oral Polio Vaccine (nOPV) 2, there was a need to monitor AEFI in the Country. A cross-sectional study was conducted from July to December 2022. Data on AEFI per region of Cameroon were reviewed for the past five years. Data were analyzed with MS Excel, and the results were presented in proportions. AEFI reporting was uncommon in Cameroon. With the introduction of novel vaccines in 2021, the health authorities engaged in new tools and training to capture cases. AEFI detected almost doubled using the open data kit (ODK) compared to previous platforms, especially following the introduction of the nOPV2 and COVID-19 vaccines. The AEFI rate was 1.9 and 160 per administered 100 000 doses of nOPV2 and COVID-19 vaccines, respectively. This mobile tool captured individual information for people with AEFI from all regions. The platform helped to identify common AEFI following the use of these new vaccines. The ODK mobile technology was vital in improving AEFI reporting and providing data to monitor using new vaccines in Cameroon.

Keywords: adverse events following immunization, cameroon, COVID-19 vaccines, nOPV, ODK

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Authors: Kasun U. G. Palihakkara

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Although vaccine coverage in Sri Lanka is close to 100%, with the widely spreading vaccine rejection trend reaching South Asian regions, it is essential to catch on whether Sri Lankans are being misinformed from the common misconceptions regarding vaccines. As the rates of target diseases decrease, parents become less accepting of even minor common adverse events. It is essential to preserve the integrity of immunization programs and protect public health by finding out the prevalence of anti-immunization trends. The primary objective of this study was to assess the immunization practices and prevalence of trends related to anti-immunization among urban community in Sri Lanka. A descriptive cross-sectional quantitative study on 323 participants using convenient sampling with 213 self-administered questionnaires. Additionally, 110 online questionnaires were distributed. 31% of the study population does not maintain immunization records for their children. While majority seek information regarding immunization from reliable sources such as the family physician or specialist pediatricians, 30% also refer to unreliable sources such as online communities for their opinion. 31% of study population had not vaccinated for Japanese encephalitis. 73% of the study population had encountered with side effects of vaccination such as fever & 47% believed that such side effects are rare. 52% of the population had hostile attitude regarding the administration of several doses multiple vaccines within a child’s first year. Diseases like polio had been successfully eradicated from Sri Lanka with the help of vigorous vaccination programs. However, majority of the study population believe that there’s no need to keep vaccinating the children for those eradicated diseases and exposing the child for adverse effects of such vaccines. Majority of the population were aware of the existing misconceptions regarding immunization. The most popular misconceptions about vaccines popular among the study population were the MMR (Measles, Mumps, and Rubella) vaccine being a possible cause leading to autism and bowel disease and children getting infected with the disease even after they get vaccinated, may be due to the inactivated vaccine. Disturbingly 22% of the study population believed that vaccines are useless in preventing diseases nowadays. These data obtained from the urban study population reveals that even though statistically Sri Lankan immunization coverage is 100%, there is a possibility of anti-vaccination trend arising in Sri Lanka due to the prevalence of various misconceptions and rumors related to it. Therefore these data recommend the need for thorough awareness among the mothers.

Keywords: anti-vaccination, immunization, infectious diseases, pediatric health

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Authors: Humraaz Kaja, Kofi Mensah, Frasia Oosthuizen

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Background and Aim: Vilazodone was approved in 2011 as an antidepressant to treat the major depressive disorder. As a relatively new drug, it is not clear if all adverse effects have been identified. The aim of this study was to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM) in order to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method: Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analyzed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post-marketing. Results: A total of 9708 adverse events had been recorded on VigiAccess, of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastro-intestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions: In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued post-marketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.

Keywords: adverse drug reactions, pharmacovigilance, post-marketing surveillance, vilazodone

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Authors: Hiranmoyee Das

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Aim. Due to late presentation and delayed diagnosis mortality rate of retinoblastoma is more than 50% in developing counties. So to facilitate the diagnosis, to decrease the disease and treatment burden and to increase the disease survival rate, an attempt was made for early diagnosis of Retinoblastoma by including fundus examination in routine immunization programs. Methods- A unique immunization card is followed in a tertiary health care center where examination of pupillary reflex is made mandatory in each visit of the child for routine immunization. In case of any abnormality, the child is referred to the ophthalmology department. Conclusion- Early detection is the key in the management of retinoblastoma. Every child is brought to the health care system at least five times before the age of 2 years for routine immunization. We should not miss this golden opportunity for early detection of retinoblastoma.

Keywords: retinoblastoma, immunization, unique, early

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Authors: Eunjoo Lee

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Background: As the number of surgeries increases, the incidence of adverse events is likely to become more prevalent. Patients who are somewhat knowledgeable about surgery-related adverse events are more likely to engage in safety initiatives to prevent them. Objectives: To evaluate the impact of a smartphone application developed during the study to enhance patients’ knowledge of surgery-related adverse events during hospitalization. Design: Non-randomized, one group, measured pre- and post-intervention. Participants: Thirty-six hospitalized patients admitted to the orthopedics unit of a general hospital in South Korea. Methods. First, a smartphone application to enhance patients’ knowledge of surgery-related adverse events was developed through an iterative process, which included a literature review, expert consultation, and pilot testing. The application was installed on participants’ smartphones, and research assistants taught the participants to use it. Twenty-five true/false questions were used to assess patients’ knowledge of preoperative precautions (eight items), surgical site infection (five items), Foley catheter management (four items), drainage management (four items), and anesthesia-related complications (four items). Results: Overall, the percentage of correct answers increased significantly, from 57.02% to 73.82%, although answers related to a few specific topics did not increase that much. Although the patients’ understanding of drainage management and the Foley catheter did increase substantially after they used the smartphone application, it was still relatively low. Conclusions: The smartphone application developed during this study enhanced the patients’ knowledge of surgery-related adverse events during hospitalization. However, nurses must make an additional effort to help patients to understand certain topics, including drainage and Foley catheter management. Relevance to clinical practice: Insufficient patient knowledge increases the risk of adverse events during hospitalization. Nurses should take active steps to enhance patients’ knowledge of a range of safety issues during hospitalization, in order to decrease the number of surgery-related adverse events.

Keywords: patient education, patient participation, patient safety, smartphone application, surgical errors

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Authors: Kwaku Damoah

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This study presents a comprehensive data-driven analysis to understand the evolution of adverse events (AEs) in pharmacovigilance. Utilizing data from the FDA Adverse Event Reporting System (FAERS), we employed three analytical methods: rank-based, frequency-based, and percentage change analyses. These methods assessed temporal trends and patterns in AE reporting, focusing on various drug-active ingredients and patient demographics. Our findings reveal significant trends in AE occurrences, with both increasing and decreasing patterns from 2000 to 2023. This research highlights the importance of continuous monitoring and advanced analysis in pharmacovigilance, offering valuable insights for healthcare professionals and policymakers to enhance drug safety.

Keywords: event analysis, FDA adverse event reporting system, pharmacovigilance, temporal trend analysis

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Authors: Giulia Bonaldo, Alberto Vaccheri, Ottavio D'Annibali, Domenico Motola

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The Human Papilloma Virus (HPV) was shown to be the cause of different types of carcinomas, first of all of the cervical intraepithelial neoplasia. Since the early 80s to today, thanks first to the preventive screening campaigns (pap-test) and following to the introduction of HPV vaccines on the market; the number of new cases of cervical cancer has decreased significantly. The HPV vaccines currently approved are three: Cervarix® (HPV2 - virus type: 16 and 18), Gardasil® (HPV4 - 6, 11, 16, 18) and Gardasil 9® (HPV9 - 6, 11, 16, 18, 31, 33, 45, 52, 58), which all protect against the two high-risk HPVs (6, 11) that are mainly involved in cervical cancers. Despite the remarkable effectiveness of these vaccines has been demonstrated, in the recent years, there have been many complaints about their risk-benefit profile due to Adverse Events Following Immunization (AEFI). The purpose of this study is to provide a support about the ongoing discussion on the safety profile of HPV vaccines based on real life data deriving from spontaneous reports of suspected AEFIs collected in the Vaccine Adverse Events Reporting System (VAERS). VAERS is a freely-available national vaccine safety surveillance database of AEFI, co-administered by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). We collected all the reports between January 2007 to December 2017 related to the HPV vaccines with a brand name (HPV2, HPV4, HPV9) or without (HPVX). A disproportionality analysis using Reporting Odds Ratio (ROR) with 95% confidence interval and p value ≤ 0.05 was performed. Over the 10-year period, 54889 reports of AEFI related to HPV vaccines reported in VAERS, corresponding to 224863 vaccine-event pairs, were retrieved. The highest number of reports was related to Gardasil (n = 42244), followed by Gardasil 9 (7212) and Cervarix (3904). The brand name of the HPV vaccine was not reported in 1529 cases. The two events more frequently reported and statistically significant for each vaccine were: dizziness (n = 5053) ROR = 1.28 (CI95% 1.24 – 1.31) and syncope (4808) ROR = 1.21 (1.17 – 1.25) for Gardasil. For Gardasil 9, injection site pain (305) ROR = 1.40 (1.25 – 1.57) and injection site erythema (297) ROR = 1.88 (1.67 – 2.10) and for Cervarix, headache (672) ROR = 1.14 (1.06 – 1.23) and loss of consciousness (528) ROR = 1.71 (1.57 – 1.87). In total, we collected 406 reports of death and 2461 cases of permanent disability in the ten-year period. The events consisting of incorrect vaccine storage or incorrect administration were not considered. The AEFI analysis showed that the most frequently reported events are non-serious and listed in the corresponding SmPCs. In addition to these, potential safety signals arose regarding less frequent and severe AEFIs that would deserve further investigation. This already happened with the referral of the European Medicines Agency (EMA) for the adverse events POTS (Postural Orthostatic Tachycardia Syndrome) and CRPS (Complex Regional Pain Syndrome) associated with anti-papillomavirus vaccines.

Keywords: adverse drug reactions, pharmacovigilance, safety, vaccines

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Authors: Melaku Tsehay

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The Consortium of Christian Relief and Development Associations (CCRDA), and the CORE Group Polio Partners (CGPP) Secretariat have been working with Global Alliance for Vac-cines and Immunization (GAVI) to improve the immunization data quality in Afar and Somali Regional States. The main aim of this study was to compare the quality of immunization data before and after the above interventions in health facilities in the pastoralist communities in Ethiopia. To this end, a comparative-cross-sectional study was conducted on 51 health facilities. The baseline data was collected in May 2019, while the end line data in August 2021. The WHO data quality self-assessment tool (DQS) was used to collect data. A significant improvment was seen in the accuracy of the pentavalent vaccine (PT)1 (p = 0.012) data at the health posts (HP), while PT3 (p = 0.010), and Measles (p = 0.020) at the health centers (HC). Besides, a highly sig-nificant improvment was observed in the accuracy of tetanus toxoid (TT)2 data at HP (p < 0.001). The level of over- or under-reporting was found to be < 8%, at the HP, and < 10% at the HC for PT3. The data completeness was also increased from 72.09% to 88.89% at the HC. Nearly 74% of the health facilities timely reported their respective immunization data, which is much better than the baseline (7.1%) (p < 0.001). These findings may provide some hints for the policies and pro-grams targetting on improving immunization data qaulity in the pastoralist communities.

Keywords: data quality, immunization, verification factor, pastoralist region

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Authors: Kye Gilder, Kevin Shan, Amy Halseth, Steve Smith

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This study assessed the effect of prolonged-release naltrexone 32 mg/bupropion 360 mg (NB) on cardiovascular (CV) events in overweight/obese participants at elevated CV risk. Participants must lose ≥2% body weight at 16 wks, without a sustained increase in blood pressure, to continue drug. Only serious adverse events (SAE) and adverse events leading to discontinuation of study drug (AELDSD) were collected. The study was terminated early after second interim analysis with 50% of all CV events. Data on CV endpoints has been published. Current analyses focused on AEs in participants on antidepressants at baseline, as these individuals were excluded from Phase 3 trials. Intent-to-treat (ITT) population (placebo [PBO] N=4450, NB N=4455) was 54.5% female, 83.5% white, mean age of 61 yrs, mean BMI 37.3 kg/m2, 22.8% with a history of depression, 23.1% on antidepressants, including 15.4% on an SSRI. SAEs in participants receiving antidepressants was similar between NB (10.7%) and PBO (9.9%) and also similar to overall population (9.5% NB, 8.1% PBO). SAEs in those on SSRIs were similar, 10.1% NB and PBO 9.4%. For those on SSRIs or other antidepressants, AELDSDs were similar to overall population and were primarily GI disorders. Obesity increases the risk of developing depression. For participants taking NB and antidepressants, including SSRIs, there is a similar AE profile as the overall population and data revealed no evidence of an additional health risk with combined use.

Keywords: antidepressant, Contrave, Mysimba, obesity, pharmacotherapy

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Authors: Mareen Brosterhaus, Antje Hammer, Steffen Kalina, Stefan Grau, Anjali A. Roeth, Hany Ashmawy, Thomas Gross, Marcel Binnebosel, Wolfram T. Knoefel, Tanja Manser

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Background: The identification of critical incidents in hospitals is an essential component of improving patient safety. To date, various methods have been used to measure and characterize such critical incidents. These methods are often viewed by physicians and nurses as external quality assurance, and this creates obstacles to the reporting events and the implementation of recommendations in practice. One way to overcome this problem is to use tools that directly involve staff in measuring indicators of quality and safety of care in the department. One such instrument is the global trigger tool (GTT), which helps physicians and nurses identify adverse events by systematically reviewing randomly selected patient records. Based on so-called ‘triggers’ (warning signals), indications of adverse events can be given. While the tool is already used internationally, its implementation in German hospitals has been very limited. Objectives: This study aimed to assess the feasibility and potential of the global trigger tool for identifying adverse events in German hospitals. Methods: A total of 120 patient records were randomly selected from two surgical, and one neurosurgery, departments of three university hospitals in Germany over a period of two months per department between January and July, 2017. The records were reviewed using an adaptation of the German version of the Institute for Healthcare Improvement Global Trigger Tool to identify triggers and adverse event rates per 1000 patient days and per 100 admissions. The severity of adverse events was classified using the National Coordinating Council for Medication Error Reporting and Prevention. Results: A total of 53 adverse events were detected in the three departments. This corresponded to adverse event rates of 25.5-72.1 per 1000 patient-days and from 25.0 to 60.0 per 100 admissions across the three departments. 98.1% of identified adverse events were associated with non-permanent harm without (Category E–71.7%) or with (Category F–26.4%) the need for prolonged hospitalization. One adverse event (1.9%) was associated with potentially permanent harm to the patient. We also identified practical challenges in the implementation of the tool, such as the need for adaptation of the global trigger tool to the respective department. Conclusions: The global trigger tool is feasible and an effective instrument for quality measurement when adapted to the departmental specifics. Based on our experience, we recommend a continuous use of the tool thereby directly involving clinicians in quality improvement.

Keywords: adverse events, global trigger tool, patient safety, record review

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Authors: Fahad Raj Khan, Suleman Khan

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There is a lack of consensus about the predictive value of raised blood glucose levels in terms of major adverse cardiac events (MACEs) in non-diabetic patients admitted for acute decompensated heart failure. The purpose of this research was to examine the long-term prognosis of acute decompensated heart failure (ADHF) in non-diabetic persons who had increased blood glucose levels, i.e., stress hyperglycemia, at the time of their ADHF hospitalization. The research involved 650 non-diabetic patients. Based on their admission stress hyperglycemia, they were divided into two groups.ie with and without (SHGL). The two groups' one-year outcomes for major adverse cardiac events (MACEs) were compared, and key predictors of MACEs were discovered. For statistical analysis, the two-tailed Mann-Whitney U test, Fisher's exact test, and binary logistic regression analysis were utilized. SHGL was found in 353 (54.3%) individuals. It was more frequent in men than in women. About 27% of patients with SHGL had previously been admitted for ADHF. Almost 62% were hypertensive, whereas 14 % had CKD. MACEs were significantly predicted by SHGL, HTN, prior hospitalization for ADHF, CKD, and cardiogenic shock upon admission. SHGL at the time of ADHF admission, independent of DM status, may be a predictive indication of MACEs.

Keywords: stress hyperglycemia, acute heart failure, major adverse cardiac events, MACEs

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Authors: S. Kurian, S. Satpathy, S. K. Gupta, S. Arya, D. K. Sharma

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Advances in the use of health care technology have resulted in increased adverse events (AEs) related to the use of medical devices. The study focused on the existing reporting systems. This study was conducted in a tertiary care public sector hospital. Devices included Syringe infusion pumps, Cardiac monitors, Pulse oximeters, Ventilators and Defibrillators. A total of 211 respondents were recruited. Interviews were held with 30 key informants. Medical records were scrutinized. Relevant statistical tests were used. Resident doctors reported maximum frequency of AEs, followed by nurses; and least by consultants. A significant association was found between the cadre of health care personnel and awareness that the patients and bystanders have a risk of sustaining AE. Awareness regarding reporting of AEs was low, and it was generally done verbally. Other critical findings are discussed in the light of the barriers to reporting, reasons for non-compliance, recording system, and so on.

Keywords: adverse events, health care technology, medical devices, public sector hospital, reporting systems

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Authors: George Lin

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This study examines a practice in which Chinese municipal governments actively pursue momentary and spectacular urbanism through the hosting of mega-events as an instrument to reproduce urban space for the enhancement of place competitiveness and advancement of political career. Practicing event-driven spectacular urbanism is found to have a short-term impact upon the economy and an effect upon the career advancement of the party secretary more than the mayor. Hosting mega-events has been used as a means to create “a harmonious society” and unified social space whereby grievance and discontents are grossed over, ignored, excluded and marginalized. Geographically, a new urban space has been created for the central city to reassert/consolidate its leading competitive position in the regional and national economy at the expense of the disadvantaged and marginalized. Findings of this research call for a critical re-evaluation of the sophisticated state-space inter-relations in the ongoing processes of planetary urbanization and global urban revolution in which China has taken an important part.

Keywords: Chinese cities, mega events, urbanism, urbanization

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Authors: Rodchares Hanrinth, Theerapong Srisil, Peeraya Sriphong, Pawich Paktipat

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The trigger tool is the low-cost, low-tech method to detect adverse events through clues called triggers. The Institute for Healthcare Improvement (IHI) has developed the Global Trigger Tool for measuring and preventing adverse events. However, this tool is not specific for detecting adverse drug events. The pharmacy-based trigger tool is needed to detect adverse drug events (ADEs). Group concept mapping is an effective method for conceptualizing various ideas from diverse stakeholders. This technique was used to identify a pharmacy-based trigger to detect adverse drug events (ADEs). The aim of this study was to involve the pharmacists in conceptualizing, developing, and prioritizing a feasible trigger tool to detect adverse drug events in a provincial hospital, the northeastern part of Thailand. The study was conducted during the 6-month period between April 1 and September 30, 2017. Study participants involved 20 pharmacists (17 hospital pharmacists and 3 pharmacy lecturers) engaging in three concept mapping workshops. In this meeting, the concept mapping technique created by Trochim, a highly constructed qualitative group technic for idea generating and sharing, was used to produce and construct participants' views on what triggers were potential to detect ADEs. During the workshops, participants (n = 20) were asked to individually rate the feasibility and potentiality of each trigger and to group them into relevant categories to enable multidimensional scaling and hierarchical cluster analysis. The outputs of analysis included the trigger list, cluster list, point map, point rating map, cluster map, and cluster rating map. The three workshops together resulted in 21 different triggers that were structured in a framework forming 5 clusters: drug allergy, drugs induced diseases, dosage adjustment in renal diseases, potassium concerning, and drug overdose. The first cluster is drug allergy such as the doctor’s orders for dexamethasone injection combined with chlorpheniramine injection. Later, the diagnosis of drug-induced hepatitis in a patient taking anti-tuberculosis drugs is one trigger in the ‘drugs induced diseases’ cluster. Then, for the third cluster, the doctor’s orders for enalapril combined with ibuprofen in a patient with chronic kidney disease is the example of a trigger. The doctor’s orders for digoxin in a patient with hypokalemia is a trigger in a cluster. Finally, the doctor’s orders for naloxone with narcotic overdose was classified as a trigger in a cluster. This study generated triggers that are similar to some of IHI Global trigger tool, especially in the medication module such as drug allergy and drug overdose. However, there are some specific aspects of this tool, including drug-induced diseases, dosage adjustment in renal diseases, and potassium concerning which do not contain in any trigger tools. The pharmacy-based trigger tool is suitable for pharmacists in hospitals to detect potential adverse drug events using clues of triggers.

Keywords: adverse drug events, concept mapping, hospital, pharmacy-based trigger tool

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Authors: Farina Maqbool

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Background: It is well said that children are considered the future masons of the country and a healthy brain is found in a healthy body. Therefore, a healthy generation can be produced by giving knowledge of immunization to mothers. Immunization is the most lucrative public health intrusion that has placed the greatest effect on the health of the people. The main objective of the present study was to find out the mother’s knowledge, attitude, and practices towards childhood immunization. Methods: Multistage sampling technique was used. One hundred and sixty mothers were selected conveniently who have at least one child up to two years. Data were collected through the face to face interview. The chi-square test was used to test the significance of the association between independent and dependent variables. Data were analyzed using the Statistical Package for Social Science. Results: A higher percentage of mothers (85.0%) knew vaccine-preventable diseases. Major proportion (82.5%) of the mothers had thought that immunization is important for their child’s health. A majority (66.3%) of the respondents’ children were fully immunized, whereas 26.3 percent of them were replied negatively. Remaining 7.5 percent of the respondents’ child un-immunized Chi-square value (39.14) shows a highly significant association between the education of the respondents and receiving of all recommended vaccines for children. Gamma value shows a strong positive relationship between the variables.

Keywords: attitude, childhood, immunization, knowledge, practices

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Authors: Kennedy Efosa Ehimwenma, Sujatha Krishnamoorthy, Safiya Al‑Sharji

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The probability computation of events is in the interval of [0, 1], which are values that are determined by the number of outcomes of events in a sample space S. The probability Pr(A) that an event A will never occur is 0. The probability Pr(B) that event B will certainly occur is 1. This makes both events A and B a certainty. Furthermore, the sum of probabilities Pr(E₁) + Pr(E₂) + … + Pr(Eₙ) of a finite set of events in a given sample space S equals 1. Conversely, the difference of the sum of two probabilities that will certainly occur is 0. This paper first discusses Bayes, the complement of probability, and the difference of probability for occurrences of learning-events before applying them in the prediction of learning objects in student learning. Given the sum of 1; to make a recommendation for student learning, this paper proposes that the difference of argMaxPr(S) and the probability of student-performance quantifies the weight of learning objects for students. Using a dataset of skill-set, the computational procedure demonstrates i) the probability of skill-set events that have occurred that would lead to higher-level learning; ii) the probability of the events that have not occurred that requires subject-matter relearning; iii) accuracy of the decision tree in the prediction of student performance into class labels and iv) information entropy about skill-set data and its implication on student cognitive performance and recommendation of learning.

Keywords: complement of probability, Bayes’ rule, prediction, pre-assessments, computational education, information theory

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Authors: Harish Krishnamurthy, Anna Lafontant, Ren Yi

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Unidentified Flying Objects (UFOs) have been an interesting topic for most enthusiasts and hence people all over the United States report such findings online at the National UFO Report Center (NUFORC). Some of these reports are a hoax and among those that seem legitimate, our task is not to establish that these events confirm that they indeed are events related to flying objects from aliens in outer space. Rather, we intend to identify if the report was a hoax as was identified by the UFO database team with their existing curation criterion. However, the database provides a wealth of information that can be exploited to provide various analyses and insights such as social reporting, identifying real-time spatial events and much more. We perform analysis to localize these time-series geospatial events and correlate with known real-time events. This paper does not confirm any legitimacy of alien activity, but rather attempts to gather information from likely legitimate reports of UFOs by studying the online reports. These events happen in geospatial clusters and also are time-based. We look at cluster density and data visualization to search the space of various cluster realizations to decide best probable clusters that provide us information about the proximity of such activity. A random forest classifier is also presented that is used to identify true events and hoax events, using the best possible features available such as region, week, time-period and duration. Lastly, we show the performance of the scheme on various days and correlate with real-time events where one of the UFO reports strongly correlates to a missile test conducted in the United States.

Keywords: time-series clustering, feature extraction, hoax prediction, geospatial events

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Authors: Willy Mbenza, Sho Kenjiro

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Increasing efforts are directed towards a better understanding and foreknowledge of extreme precipitation likelihood, given the adverse effects associated with their occurrence. This knowledge plays a crucial role in long-term planning and the formulation of effective emergency response. However, predicting extreme events reliably presents a challenge to conventional empirical/statistics due to the involvement of numerous variables spanning different time and space scales. In the recent time, Machine Learning has emerged as a promising tool for predicting the dynamics of extreme precipitation. ML techniques enables the consideration of both local and regional physical variables that have a strong influence on the likelihood of extreme precipitation. These variables encompasses factors such as air temperature, soil moisture, specific humidity, aerosol concentration, among others. In this study, we develop an ML model that incorporates both local and regional variables while establishing a robust relationship between physical variables and precipitation during the downscaling process. Furthermore, the model provides valuable information on the frequency and duration of a given intensity of precipitation.

Keywords: machine learning (ML), predictions, rainfall events, regional variables

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Authors: Ahmad Daryani, Yousef Dadimoghaddam, Mehdi Sharif, Ehsan Ahmadpour, Shahabeddin Sarvi, Baghar Hashemi

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Background: Excretory-secretory antigens (ESAs) of Toxoplasma gondii are one of the candidates for immunization against toxoplasmosis. For evaluation of immunization, we determined the kinetics of the distribution of Toxoplasma and parasite load in different tissues of mice immunized by ESAs. Methods: In this experimental study, 36 mice in case (n= 18) and control (n= 18) groups were immunized with ESAs and PBS, respectively. After 2 weeks, mice were challenged intraperitoneally with Toxoplasma virulent RH strain. Blood and different tissues (brain, spleen, liver, heart, kidney, and muscle) were collected daily after challenge (1, 2, 3 and last day before death). Parasite load was calculated using Real time QPCR targeted at the B1 gene. Results: ESAs as vaccine in different tissues showed various effects. However, infected mice which received the vaccine in comparison with control group, displayed a drastically decreasing in parasite burden, in their blood and tissues (P= 0.000). Conclusion: These results indicated that ESAs with reduction of parasite load in different tissues of host could be evaluable candidate for the development of immunization strategies against toxoplasmosis.

Keywords: parasitic load, murine toxoplasmosis, immunization, excretory-secretory antigens, real time QPCR

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Authors: Zhipeng Yan, Janice Wing-Tung Kwong, Ching-Lung Lai

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Background: Advanced melanoma accounts for the majority of skin cancer death due to its poor prognosis. Nivolumab and ipilimumab are monoclonal antibodies targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocytes antigen 4 (CTLA-4). Nivolumab and ipilimumab combination therapy has been proven to be effective for advanced melanoma. This systematic review and meta-analysis are to evaluate its clinical efficacy and adverse events. Method: A systematic search was done on databases (Pubmed, Embase, Medline, Cochrane) on 21 June 2020. Search keywords were nivolumab, ipilimumab, melanoma, and randomised controlled trials. Clinical trials fulfilling the inclusion criteria were selected to evaluate the efficacy of combination therapy in terms of prolongation of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). The odd ratios and distributions of grade 3 or above adverse events were documented. Subgroup analysis was performed based on PD-L1 expression-status and BRAF-mutation status. Results: Compared with nivolumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR in combination therapy were 0.64 (95% CI, 0.48-0.85; p=0.002), 0.84 (95% CI, 0.74-0.95; p=0.007) and 1.76 (95% CI, 1.51-2.06; p < 0.001), respectively. Compared with ipilimumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR were 0.46 (95% CI, 0.37-0.57; p < 0.001), 0.54 (95% CI, 0.48-0.61; p < 0.001) and 6.18 (95% CI, 5.19-7.36; p < 0.001), respectively. In combination therapy, the odds ratios of grade 3 or above adverse events were 4.71 (95% CI, 3.57-6.22; p < 0.001) compared with nivolumab monotherapy, and 3.44 (95% CI, 2.49-4.74; p < 0.001) compared with ipilimumab monotherapy, respectively. High PD-L1 expression level and BRAF mutation were associated with better clinical outcomes in patients receiving combination therapy. Conclusion: Combination therapy is effective for the treatment of advanced melanoma. Adverse events were common but manageable. Better clinical outcomes were observed in patients with high PD-L1 expression levels and positive BRAF-mutation.

Keywords: nivolumab, ipilimumab, advanced melanoma, systematic review, meta-analysis

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Authors: Betty Makena, Tsegaye Tadesse, Mark Svoboda

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Global warming has intensified the frequency and intensity of extreme climate disasters and led to unpredictable weather conditions. Consequently, rapid shifts between drought and floods, known as Drought-Flood Abrupt Alteration (DFAA), have become increasingly common. DFAA results in superimposed impacts of drought and floods within a short period, exacerbating the effects of the floods or drought event. Current disaster management plans often overlook DFAA events, as they primarily focus on either floods or drought. Therefore, effectively identifying DFAA events is crucial for developing effective mitigation strategies. This study aims to identify historical DFAA events in Kenya using the Long Cycle Drought-Flood Abrupt Alteration Index (LDFAI). The research will analyze the spatial distribution, temporal variation, and intensity of DFAA events from 1990 to 2023, as well as their socio-economic impacts. Understanding these events is important to develop more effective strategies to address the impacts of DFAA events. Findings from this study will inform decision making to develop coping strategies to mitigate the adverse effects of DFAA in Kenya.

Keywords: abrupt, alteration, drought, floods

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Authors: Sudhanshu Kumar, Raghvendra Chandrakar, Arun Chakraborty

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In the ocean, the temperature extremes have the potential to devastate marine habitats, ecosystems together with ensuing socioeconomic consequences. In recent years, these extreme events are more frequent and intense globally and their increasing trend is expected to continue in the upcoming decades. It recently attracted public interest, as well as scientific researchers, which motivates us to analyze the current marine heatwave (MHW) events in the Bay of Bengal region. we have isolated 107 MHW events (above 90th percentile threshold) in this region of the Indian Ocean and investigated the variation in duration, intensity, and frequency of MHW events during our test period (1982-2021). Our study reveals that in the study region the average of three MHW events per year with an increasing linear trend of 1.11 MHW events per decade. In the analysis, we found the longest MHW event which lasted about 99 days, which is far greater than an average MHW event duration. The maximum intensity was 5.29°C (above the climatology-mean), while the mean intensity was 2.03°C. In addition, we observed net heat flux accompanied by anticyclonic eddies to be the primary cause of these events. Moreover, we concluded that these events affect sea surface height and oceanic productivity, highlighting the adverse impact of MHWs on marine ecosystems.

Keywords: marine heatwaves, global warming, climate change, sea surface temperature, marine ecosystem

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Authors: Jai Myung Yang, Na Young Kim, Sung Ho Shin

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The adverse reactions of current live smallpox vaccines and potential use of smallpox as a bioterror weapon have heightened the development of new effective vaccine for this infectious disease. In the present study, DNA vaccine vector was produced which was optimized for expression of the vaccinia virus L1 antigen in the mouse model. A plasmid IgM-tL1R, which contains codon-optimized L1R gene, was constructed and fused with an IgM signal sequence under the regulation of a SV40 enhancer. The expression and secretion of recombinant L1 protein was confirmed in vitro 293 T cell. Mice were administered the DNA vaccine by electroporation and challenged with vaccinia virus. We observed that immunization with IgM-tL1R induced potent neutralizing antibody responses and provided complete protection against lethal vaccinia virus challenge. Isotyping studies reveal that immunoglobulin G2 (IgG2) antibody predominated after the immunization, indicative of a T helper type 1 response. Our results suggest that an optimized DNA vaccine, IgM-tL1R, can be effective in stimulating anti-vaccinia virus immune response and provide protection against lethal orthopoxvirus challenge.

Keywords: DNA vaccine, electroporation, L1R, vaccinia virus

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Authors: Nadjet Mekaouche, Hanane Zitouni, Fatma Boudia, Habiba Fetati, A. Saleh, A. Lardjam, H. Geniaux, A. Coubret, H. Toumi

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Medicines have undeniably played a major role in prolonging shelf life and improving quality. The absolute efficacy of the drug remains a lever for innovation, its benefit/risk balance is not always assured and it does not always have the expected effects. Prior to marketing, knowledge about adverse drug reactions is incomplete. Once on the market, phase IV drug studies begin. For years, the drug was prescribed with less care to a large number of very heterogeneous patients and often in combination with other drugs. It is at this point that previously unknown adverse effects may appear, hence the need for the implementation of a pharmacovigilance system. Pharmacovigilance represents all methods for detecting, evaluating, informing and preventing the risks of adverse drug reactions. The most severe adverse events occur frequently in hospital and that a significant proportion of adverse events result in hospitalizations. In addition, the consequences of hospital adverse events in terms of length of stay, mortality and costs are considerable. It, therefore, appears necessary to develop ‘hospital pharmacovigilance’ aimed at reducing the incidence of adverse reactions in hospitals. The most widely used monitoring method in pharmacovigilance is spontaneous notification. However, underreporting of adverse drug reactions is common in many countries and is a major obstacle to pharmacovigilance assessment. It is in this context that this study aims to describe the experience of the pharmacovigilance service at the University Hospital of Oran (EHUO). This is a retrospective study extending from 2011 to 2017, carried out on archived records of declarations collected at the level of the EHUO Pharmacovigilance Department. Reporting was collected by two methods: ‘spontaneous notification’ and ‘active pharmacovigilance’ targeting certain clinical services. We counted 217 statements. It involved 56% female patients and 46% male patients. Age ranged from 5 to 78 years with an average of 46 years. The most common adverse reaction was drug toxidermy. For the drugs in question, they were essentially according to the ATC classification of anti-infectives followed by anticancer drugs. As regards the evolution of declarations by year, a low rate of notification was noted in 2011. That is why we decided to set up an active approach at the level of some services where a resident of reference attended the staffs every week. This has resulted in an increase in the number of reports. The declarations came essentially from the services where the active approach was installed. This highlights the need for ongoing communication between all relevant health actors to stimulate reporting and secure drug treatments.

Keywords: adverse drug reactions, hospital, pharmacovigilance, spontaneous notification

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Authors: Pranee Suecharoen, Ratchadaporn Soontornpas, Jaturat Kanpittaya

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Background: Contrast media has an important role for disease diagnosis through detection of pathologies. Contrast media can, however, cause adverse reactions after administration of its agents. Although non-ionic contrast media are commonly used, the incidence of adverse events is relatively low. The most common reactions found (10.5%) were mild and manageable and/or preventable. Pharmacists can play an important role in evaluating adverse reactions, including awareness of the specific preparation and the type of adverse reaction. As most common types of adverse reactions are idiosyncratic or pseudo-allergic reactions, common standards need to be established to prevent and control adverse reactions promptly and effectively. Objective: To measure the effect of using tools for symptom evaluation in order to reduce the severity, or prevent the occurrence, of adverse reactions from contrast media. Methods: Retrospective review descriptive research with data collected on adverse reactions assessment and Naranjo’s algorithm between June 2015 and May 2016. Results: 158 patients (10.53%) had adverse reactions. Of the 1,500 participants with an adverse event evaluation, 137 (9.13%) had a mild adverse reaction, including hives, nausea, vomiting, dizziness, and headache. These types of symptoms can be treated (i.e., with antihistamines, anti-emetics) and the patient recovers completely within one day. The group with moderate adverse reactions, numbering 18 cases (1.2%), had hypertension or hypotension, and shortness of breath. Severe adverse reactions numbered 3 cases (0.2%) and included swelling of the larynx, cardiac arrest, and loss of consciousness, requiring immediate treatment. No other complications under close medical supervision were recorded (i.e., corticosteroids use, epinephrine, dopamine, atropine, or life-saving devices). Using the guideline, therapies are divided into general and specific and are performed according to the severity, risk factors and ingestion of contrast media agents. Patients who have high-risk factors were screened and treated (i.e., prophylactic premedication) for prevention of severe adverse reactions, especially those with renal failure. Thus, awareness for the need for prescreening of different risk factors is necessary for early recognition and prompt treatment. Conclusion: Studying adverse reactions can be used to develop a model for reducing the level of severity and setting a guideline for a standardized, multidisciplinary approach to adverse reactions.

Keywords: role of pharmacist, management of adverse reactions, guideline for contrast media, non-ionic contrast media

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Authors: Sandipika Gupta

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Objective: Due to admirably low 30-day mortality rates for paediatric cardiac surgery, it is now pertinent to turn towards more intermediate-length outcomes such as morbidities closely associated with these surgeries. One such morbidity, major adverse events (MAE) comprises a group of adverse outcomes associated with paediatric cardiac surgery (e.g. cardiac arrest, major haemorrhage). Methods: This is a retrospective study that analysed the incidence and impact of MAE which was the primary outcome in the UK population. The data was collected in 5 centres between October 2015 and June 2017, amassing 3090 surgical episodes. The incidence and risk factors for MAE, were assessed through descriptive statistical analyses and multivariate logistic regression. The secondary outcomes of life status at 6 months and the length of hospital stay were also evaluated to understand the impact of MAE on patients. Results: Out of 3090 episodes, 134 (4.3%) had a postoperative MAE. The majority of the episodes were in: neonates (47%, P<0.001), high-risk cardiac diagnosis groups (20.1%, P<0.001), episodes with longer 5mes on the bypass (72.4%, P<0.001) and urgent surgeries (57.9%, P<0.001). Episodes reporting MAE also reported longer lengths of stay in hospital (29 days vs 9 days, P<0.001). Furthermore, patients experiencing MAE were at a higher risk of mortality at the 6-month life status check (mortality rates: 29.2% vs 2%, P<0.001).Conclusions: Key risk factors were identified. An important negative impact of MAE was found for patients. The identified risk factors could be used to profile and flag at-risk patients. Monitoring of MAE rates and closer investigation into the care pathway before and after individual MAEs in children’s heart units may lead to a reduction in these terrible events.

Keywords:

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Authors: Warda Ajaz

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This study uses the ‘Community Capitals Framework’ (CCF) to develop a community resilience index that can serve as a useful tool for measuring resilience of communities in diverse contexts and backgrounds. CCF is an important analytical tool to assess holistic community change. This framework identifies seven major types of community capitals: natural, cultural, human, social, political, financial and built, and claims that the communities that have been successful in supporting healthy sustainable community and economic development have paid attention to all these capitals. The framework, therefore, proposes to study the community development through identification of assets in these major capitals (stock), investment in these capitals (flow), and the interaction between these capitals. Capital based approaches have been extensively used to assess community resilience, especially in the context of natural disasters and extreme events. Therefore, this study identifies key indicators for estimating each of the seven capitals through an extensive literature review and then develops an index to calculate a community resilience score. The CCF-based community resilience index presents an innovative way of operationalizing the concept of community resilience and will contribute toward decision-relevant research regarding adaptation and mitigation of community vulnerabilities to climate change-induced, as well as other adverse events.

Keywords: adverse events, community capitals, community resilience, climate change, economic development, sustainability

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