Evaluation of adverse effects/events of genetically modified food consumption: a systematic review of animal and human studies

Objective A systematic review of animal and human studies was conducted on genetically modified (GM) food consumption to assess its safety in terms of adverse effects/events to inform public concerns and future research. Methods Seven electronic databases were searched from January 1st 1983 till July 11th 2020 for in vivo, animal and human studies on the incidence of adverse effects/events of GM products consumption. Two authors independently identified eligible studies, assessed the study quality, and extracted data on the name of the periodical, author and affiliation, literature type, the theme of the study, publication year, funding, sample size, target population characteristics, type of the intervention/exposure, outcomes and outcome measures, and details of adverse effects/events. We used the Chi-square test to compare the adverse event reporting rates in articles funded by industry funding, government funding or unfunded articles. Results One crossover trial in humans and 203 animal studies from 179 articles met the inclusion criteria. The study quality was all assessed as being unclear or having a high risk of bias. Minor illnesses were reported in the human trial. Among the 204 studies, 59.46% of adverse events (22 of 37) were serious adverse events from 16 animal studies (7.84%). No significant differences were found in the adverse event reporting rates either between industry and government funding (χ2 = 2.286, P = 0.131), industry and non-industry funding (χ2 = 1.761, P = 0.185) or funded and non-funded articles (χ2 = 0.491, P = 0.483). We finally identified 21 GM food-related adverse events involving 7 GM events (NK603 × MON810 maize, GTS 40-3-2 soybean, NK603 maize, MON863 maize, MON810 maize, MON863 × MON810 × NK603 maize and GM Shanyou 63 rice), which had all been on regulatory approval in some countries/regions. Conclusion Serious adverse events of GM consumption include mortality, tumour or cancer, significant low fertility, decreased learning and reaction abilities, and some organ abnormalities. Further clinical trials and long-term cohort studies in human populations, especially on GM food-related adverse events and the corresponding GM events, are still warranted. It suggests the necessity of labelling GM food so that consumers can make their own choice.

Expressive Power of Anti-Violence Legislation

abstract We know more about why laws on violence against women (vaw) were adopted than about how much and in what ways these laws affect society. The authors argue that even weakly enforced laws can contribute to positive social change. They theorize the expressive power of vaw legislation, and present evidence for a cautiously optimistic assessment of current trends on violence against women and the ways that vaw laws affect social norms. Focusing on a time of major legal change related to vaw in Mexico, this article explores trends in behavior and attitudes related to violence by analyzing four waves of the National Survey on the Dynamics of Household Relations (endireh), which include detailed interviews with thousands of Mexican women. The authors find that over this period, the share of women experiencing intimate-partner abuse declined, attitudes condoning violence shifted, reporting rates rose, and most women learned about legislation to protect their rights. These changes are consistent with the authors’ expectations about the expressive power of anti-violence legislation.

Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination

Objectives: To determine whether spontaneous reporting rates of myocarditis and pericarditis differed in immunocompromised patients compared to the whole population overall, and in terms of demographics, vaccine dose, and time-to-onset. Design: Systematic review of spontaneously reported data from the European Union/European Economic Area (EU/EEA) and the United States (US). Data Sources: EudraVigilance (EU/EEA) and Vaccine Adverse Event Reporting System (VAERS; US) spontaneous reporting databases were searched from date of vaccine launch to 30 November 2021. Eligibility criteria: Publicly available spontaneous reporting data for 'Myocarditis' and 'Pericarditis' from EU/EEA and US following COVID-19 mRNA vaccines. Reports with comorbidities or concurrent medication indicative of transplantation, HIV infection, or cancer ('immunocompromised' population) were compared with each overall database population. Data extraction and synthesis: Two researchers extracted data. Spontaneously reported events of myocarditis and pericarditis were presented for immunocompromised populations for each data source, stratified by age, sex, dose, and time-to-onset (where available). Seriousness of each event was determined according to the ICH E2A definition. Proportional Reporting Ratio (PRR) was calculated. Results: There were 106 reports of myocarditis and pericarditis amongst immunocompromised individuals overall. Seriousness was comparable between the immunocompromised and overall populations in both databases. No trends in age or sex were observed amongst immunocompromised individuals. Most reports (54.4%) to VAERS followed a second vaccine dose and 70.2% of events occurred within 14 days. The frequency of reporting was similar to the wider population (PRR=1.36 [95% CI= 0.89-1.82] for VAERS population). Conclusions: Myocarditis and pericarditis following COVID-19 vaccination are very rare, and benefits of COVID-19 vaccination continue to outweigh any perceived risks. Reporting rates of myocarditis and pericarditis were similar in immunocompromised individuals, however defining characteristics differed compared to the whole population; therefore, continued monitoring of adverse events following vaccination remains vital to understand differences between population subgroups.

Global incidence proportion of intraventricular haemorrhage of prematurity: a meta-analysis of studies published 2010–2020

ObjectiveTo investigate differences and calculate pooled incidence of any intraventricular haemorrhage (IVH), severe IVH (Grade III/IV, sIVH) and ventriculoperitoneal shunt (VPS) placement in preterm infants across geographical, health and economic regions stratified by gestational age (GA).DesignMEDLINE, Embase, CINAHL and Web of Science were searched between 2010 and 2020. Studies reporting rates of preterm infants with any IVH, sIVH and VPS by GA subgroup were included. Meta-regression was performed to determine subgroup differences between study designs and across United Nations geographical regions, WHO mortality strata and World Bank lending regions. Incidence of any IVH, sIVH and VPS by GA subgroups<25, <28, 28–31, 32–33 and 34–36 weeks were calculated using random-effects meta-analysis.ResultsOf 6273 publications, 97 met inclusion criteria. Incidence of any IVH (37 studies 87 993 patients) was: 44.7% (95% CI 40.9% to 48.5%) for GA <25 weeks, 34.3% (95% CI 31.2% to 37.6%) for GA <28 weeks, 17.4% (95% CI 13.8% to 21.6%) for GA 28–31 weeks, 11.3% (95% CI 7.3% to 17.0%) for GA32–33 weeks and 4.9% (95% CI 1.4% to 15.2%) for GA 34–36 weeks. Incidence of sIVH (49 studies 328 562 patients) was 23.7% (95% CI 20.9% to 26.7%) for GA <25 weeks, 15.0% (95% CI 13.1% to 17.2%) for GA <28 weeks, 4.6% (95% CI 3.5% to 6.1%) for GA 28–31 weeks, 3.3% (95% CI 2.1% to 5.1%) for GA 32–33 weeks and 1.8% (95% CI 1.2% to 2.8%) for GA 34–36 weeks. Europe had lower reported incidence of any IVH and sIVH relative to North America (p<0.05). Proportion of VPS across all GA groups was 8.4% (95% CI 4.7% to 14.7%) for any IVH and 17.2% (95% CI 12.2% to 26.2%) for sIVH. Heterogeneity was high (I2 >90%) but 64%–85% of the variance was explained by GA and study inclusion criteria.ConclusionsWe report the first pooled estimates of IVH of prematurity by GA subgroup. There was high heterogeneity across studies suggesting a need for standardised incidence reporting guidelines.

2020 Pennsylvania Patient Safety Reporting: Updated Acute Care Reporting Rates

In our recent article summarizing 2020 data from acute care facilities in Pennsylvania, reporting rates and fall rates were provided for Q1 and Q2 2020 based on the latest data we had available at the time of publication. Given that 2020 was an unpredictable year in healthcare, any forecasting of rates for Q3 and Q4 2020 would have been unreliable. Therefore, this data snapshot serves to complete reporting rates for 2020 now that all hospital patient days and surgical encounters data from 2020 have been made available for rate calculations.

Improving Frontline Responses to Domestic Violence in Europe

The monograph on improving the response of first responders to domestic violence in Europe aims to identify gaps in the cooperation of first-line responders and deliver recommendations, toolkits andcollaborative training for European police organizations and medical and social work professionals. The goal is to improve integrate institutional response to domestic violence. Shared training and adequaterisk assessment tools will create a positive feedback loop, increasing reporting rates of domestic violence to police, the medical profession, and community and social work practitioners.

Systematic review of cardiac adverse effects in children and young people under 18 years of age after SARS-CoV-2 vaccination

BackgroundReports of myocarditis and pericarditis following vaccination with mRNA vaccines for SARS-CoV-2 have occurred after countries began vaccinating adolescents. We undertook a systematic review of cardiac adverse effects associated with SARS-CoV-2 vaccine in children and young people (CYP)< 18 years.MethodsSystematic review with protocol prospectively registered with PROSPERO (CRD42021275380).Six electronic databases were searched from 1 December 2019 to 14 September 2021. Eligible studies were those reporting on CYP with reported or proven myocarditis, pericarditis and/or myopericarditis associated with vaccination against SARS-CoV-2. We summarized findings across all clinical cases reported in case report / case series studies. As a number of studies reported data from two publicly available vaccine surveillance systems, we updated estimates of reporting rates for cardiac adverse events up to 31 October for the US Vaccine Adverse Event Reporting System (VAERS) and 13 November for EudraVigilance covering European Union and European Economic Area (EUEA) countries.ResultsTwenty-one studies were included from 338 identified records. Seventeen were case reports/series describing a total of 127 CYP. Three studies described reporting rates from passive surveillance databases (VAERS, EudraVigilance, and the WHO VigiBase) and one described 22 cases from the US Vaccine Safety Datalink (VSD).Clinical series reported that 99.2% presented with chest pain, 100% had raised troponin and 73.8% had an abnormal ECG. Cardiovascular magnetic resonance (CMR) in 91 cases identified myocardial injury in 61.5%, with 90.1% showing late gadolinium enhancement. NSAIDs were the most common treatment (76.0%).One US dataset (VSD) estimated a significant excess of 29.6 events per million vaccine doses across both sexes and doses. There were 1129 reports of myocarditis and 358 reports of pericarditis from across the USA and EU/EEA. The VAERS reporting rate per million for myocarditis was 12.4 for boys and 1.4 for girls after the first dose, and 49.6 for boys and 6.1 for girls after the second dose. There was a marked trend for VAERS reporting to be highest soon after initiation of the vaccine schedule, suggesting reporting bias.ConclusionsCardiac adverse effects are very rare after mRNA vaccination for COVID-19 in CYP <18 years. The great majority of cases are mild and self-limiting without significant treatment. No data are yet available on children under 12 years. Larger detailed longitudinal studies are urgently needed from active surveillance sources.

The Genetic Landscape of Patent Foramen Ovale: A Systematic Review

Patent Foramen Ovale (PFO) is a common postnatal defect of cardiac atrial septation. A certain degree of familial aggregation has been reported. Animal studies suggest the involvement of the Notch pathway and other cardiac transcription factors (GATA4, TBX20, NKX2-5) in Foramen Ovale closure. This review evaluates the contribution of genetic alterations in PFO development. We systematically reviewed studies that assessed rare and common variants in subjects with PFO. The protocol was registered with PROSPERO and followed MOOSE guidelines. We systematically searched English studies reporting rates of variants in PFO subjects until the 30th of June 2021. Among 1231 studies, we included four studies: two of them assessed the NKX2-5 gene, the remaining reported variants of chromosome 4q25 and the GATA4 S377G variant, respectively. We did not find any variant associated with PFO, except for the rs2200733 variant of chromosome 4q25 in atrial fibrillation patients. Despite the scarceness of evidence so far, animal studies and other studies that did not fulfil the criteria to be included in the review indicate a robust genetic background in PFO. More research is needed on the genetic determinants of PFO.

Epidemiology of myocarditis and pericarditis following mRNA vaccines in Ontario, Canada: by vaccine product, schedule and interval

ImportanceIncreased rates of myocarditis/pericarditis following COVID-19 mRNA vaccines have been observed. However, little data are available related to product-specific differences, which have important programmatic impacts.ObjectiveThe objective of this study was to estimate reporting rates of myocarditis/pericarditis following COVID-19 mRNA vaccine by product, age, sex, and dose number, as well inter-dose interval.DesignWe conducted a population-based cohort study using passive vaccine safety surveillance data. All individuals in Ontario, Canada who received at least one dose of COVID-19 mRNA vaccine between December 14, 2020 and September 4, 2021 were included.SettingThis study was conducted in Ontario, Canada (population: 14.7 million) using the provincial COVID-19 vaccine registry and provincial adverse events following immunization database.ParticipantsWe included all individuals with a reported episode of myocarditis/pericarditis following COVID-19 vaccine in the study period. We obtained information on all doses administered in the province to calculate reporting rates.ExposureReceipt of COVID-19 mRNA vaccine (mRNA-1273 [Moderna Spikevax] or BNT162b2 [Pfizer-BioNTech Comirnaty]).Main Outcome(s) and Measure(s)Reported rate of myocarditis/pericarditis meeting level 1-3 of the Brighton Collaboration case definitions.ResultsThere were 19,740,741 doses of mRNA vaccines administered and 297 reports of myocarditis/pericarditis meeting our inclusion criteria. Among these, 69.7% occurred following the second dose of COVID-19 mRNA vaccine and 76.8% occurred in males. The median age of individuals with a reported event was 24 years. The highest reporting rate of myocarditis/pericarditis was observed in males aged 18-24 years following mRNA-1273 as the second dose; the rate in this age group was 5.1 (95% CI 1.9-15.5) times higher than the rate following BNT162b2 as the second dose. Overall reporting rates were higher when the inter-dose interval was shorter (i.e., ≤30 days) for both vaccine products. Among individuals who received mRNA-1273 for the second dose, rates were higher for those who had a heterologous as opposed to homologous vaccine schedule.Conclusions and RelevanceOur results suggest that vaccine product, inter-dose interval and vaccine schedule combinations may play a role in the risk of myocarditis/pericarditis, in addition to age and sex. Certain programmatic strategies could reduce the risk of myocarditis/pericarditis following mRNA vaccines.

A Qualitative Study on Nurses’ Experiences of Reporting Patient Safety Incidents in East Nusa Tenggara, Indonesia

Background: Reporting patient safety incidents is important to improve patient safety and quality of care. Barriers to report patient safety incidents in nursing may occur due to lack of knowledge and unscheduled as well as low reporting rates. Unfortunately, nurses’ experiences in reporting patient safety incidents have not been comprehensively reviewed.Purpose: The purpose of this study was to explore nurses’ experiences of reporting patient safety incidents in East Nusa Tenggara, Indonesia.Methods: A descriptive phenomenological approach was used to identify, analyze and describe the experiences of 15 nurses in reporting patient safety incidents. Nurses having worked for more than two years, not on leave, not being infected with COVID-19 in the last 14 days, and not having a structural position were purposively recruited. Data were collected using in-depth interviews and voice recordings. The collected data were then transcribed verbatim, and thematic analysis was applied for data analysis.Results: Four main themes were found in this study, which included: (1) Priority and responsibility for services, (2) Barriers to incident reporting, (3) Learning for nurses, and (4) Support for nurses.Conclusion: The nurses experience of in reporting safety incidents is still constrained by several obstacles. It is hoped that health care organizations need to provide appropriate strategies to enhance the safety incident reporting efforts made by nurses. Based on the research findings, it is recommended that health service organizations disseminate the use of safety incident reporting forms and assist nursing managers to their subordinates by conducting supervision and motivation related to incident reporting on a scheduled and continuous basis.