Coercive measures to manage disruptive or violent behaviour are accepted as standard practice in mental healthcare, but systematic knowledge of potentially harmful outcomes is insufficient.

To examine the association of mechanical restraint with several predefined somatic harmful outcomes.

We conducted a population-based, observational cohort study linking data from the Danish national registers from 2007 to 2019. The primary analyses investigated the association of mechanical restraint with somatic adverse events, using panel regression analyses (within-individual analysis) to account for repeated exposures and outcomes. Secondary between-group analyses were performed with a control group exposed to types of coercion other than mechanical restraint.

The study population comprised 13 022 individuals. We report a statistically significant association of mechanical restraint with thromboembolic events (relative risk 4.377, number needed to harm (NNH) 8231), pneumonia (relative risk 5.470, NNH 3945), injuries (relative risk 2.286, NNH 3240) and all-cause death (relative risk 5.540, NNH 4043) within 30 days after mechanical restraint. Estimates from the between-group analyses (comparing the exposed group with a control group of 22 643 individuals) were non-significant or indicated increased baseline risk in the control group. A positive dose–response analysis for cardiac arrest, injury and death supported a causative role of mechanical restraint in the reported associations.

Although the observed absolute risk increases were small, the derived relative risks were non-negligible considering that less restrictive interventions are available. Clinicians and decision makers should be aware of the excess risk in future decisions on the use of mechanical restraint versus alternative interventions.

Several psychiatric adverse events can occur after vaccination. Passive surveillance reporting systems can support the identification of rare adverse events and contribute to hypothesis generation for potential causal associations.

To describe the psychiatric adverse reactions associated with various COVID-19 vaccines reported in the WHO database (VigiBase®)

We for individual case reports (ICSRs) for “Psychiatric disorders” linked to COVID-19 vaccines authorized in the EU, the US and the UK. Reporting rates were calculated using the number of administered doses as a denominator. Disproportional reporting was investigated through frequentist and Bayesian approaches by the calculation the information component (IC) for adverse psychiatric adverse not included in the vaccine label.

63322 ICSRs including 76,163 psychiatric adverse events were identified, 21878 (34.6 %) were serious events. Mean age in the reports was 48.8 years old (SD: 17.8) and involved 44441 (70.2%) female and 17975 (28.4%) women; sex was not specified in 906 (1.4%) reports. Rate of reported psychiatric adverse events per million administered doses were 52.0, 110.3, 164.8 and 170.8 for Tozinameran/Cominarty (Pfizer-BioNTech), Elasomeran (Moderna), Vaxzevria (AstraZeneca) and Ad26.COV2-S (Janssen) vaccines respectively. UK recorded the highest rates. The most frequently reported events were insomnia (21.6%), confusional state (13.6%) and anxiety (13.5%). Disproportionality was found for: habit cough (IC:3.6), clinomania (IC: 2.2), exploding head syndrome (IC: 2.2) and autoscopy (IC: 2.1).

Rates of reported psychiatric adverse events are very low. Doctors and patients should be aware of these potential adverse reactions. Continuing monitoring of emerging potential safety signals is advised.

No significant relationships.

Meditation is commonly implemented in psychological therapies since the ‘third wave’ of cognitive–behavioural therapy has increased the focus on mindfulness-based interventions. Although extensive research literature demonstrates its benefits, little is known about potential adverse effects.

The aim of this study is to report the prevalence, type and severity of particularly unpleasant meditation-related experiences in the largest cross-sectional study on this topic to date, with 1370 regular meditators.

The participants were asked whether they ever encountered particularly unpleasant experiences as a result of their meditation experience. For the first time, the type and severity of those experiences were assessed and the association with several predictors, such as pre-existing mental disorders, were explored via logistic and linear regression.

Similar to previous studies, 22% of participants (95% CI 20–24) reported having encountered unpleasant meditation-related experiences, and 13% of participants (95% CI 3–5) reported experiences that were categorised as adverse. Those were mostly of affective, somatic and cognitive nature. Unpleasant meditation-related experiences were more likely to occur in participants with pre-existing mental illnesses (P = 0.000, 95% CI 1.25–2.12).

This study demonstrates that unpleasant meditation-related experiences are prevalent among meditators and, to a relevant extent, severe enough to warrant further scientific inquiry. Longitudinal studies are needed to examine whether the unpleasant meditation-related experiences are merely negative and thus should be avoided, or are an inherent part of the contemplative path.

Over the past decades, immunotherapy treatments have been a revolution to many chronic diseases with encouraging results in clinical outcomes and quality of life. The use of monoclonal antibodies has yielded a great variability in terms of clinical efficacy and tolerability although it’s believed the incidence of psychotic symptoms is low (0,1-0,4%).

To review the effects of monoclonal antibodies on psychosis.

Review of literature using PubMed database. A total of 16 studies were included.

The targeted molecules by monoclonal antibodies may determine the risk of psychosis. While those who target TNF-alfa seem to have a reduced risk of psychosis (such as Infliximab, Adalimumab, Certolizumab and Golimumab), monoclonal antibodies who modulate lymphocytes may have a greater risk of psychosis namely Natalizumab, Belimumab, Basiliximab and Daclizumab, which seems to correlate to evidence of alterations in lymphocyte subsets in groups of patients with first psychotic episode and schizophrenia. Some seem to have positive correlation with psychosis namely monoclonal antibodies who have a supressing effect on the immune system, especially those who target adaptative immunity and those who are used in autoimmune diseases (vs oncologic conditions). It is unknown if delusions prevail over hallucinations or vice-versa. Despite the paucity of evidence, these findings corroborate the variability regarding the psychiatric effects of immunotherapy.

The available literature reports a low prevalence of psychotic symptoms associated with the use of monoclonal antibodies but it highlights the importance in knowing the immune mechanisms involved in psychotic disorders. Greater research is needed to correctly assess that risk.

The aims of the study were to investigate the burden for health care workers (HCWs) who suffer from occupational-related adverse events (ORAEs) while working in contaminated areas in a specialized hospital for novel coronavirus pneumonia, to explore related risk factors, to evaluate the effectiveness of bundled interventions, as well as to provide scientific evidence regarding the reduction of risks concerning ORAEs and occupational exposure events.

The study was completed using a special team of 138 HCWs assembled for a specialized hospital for novel coronavirus pneumonia in Wuhan, dated from February 16 to March 26, 2020. The incidence of occupational exposure was determined by data reported from the hospital, while the prevalence of ORAEs was derived from questionnaire results. The relation coefficients of ORAEs and the variable potential risk factors are analyzed by logistic regression. After the risk factors were identified, targeted organized intervention was implemented and chi-square tests were performed to compare the incidence of occupational exposure and the prevalence of ORAEs in contaminated areas before and after the interventions.

Ninety one out of 138 (65.94%) had reported ORAEs with 300 (27.96%) cases of ORAEs being recorded in a total of 1073 entries into contaminated areas. The prevalence of different ORAEs include 205 tenderness (24.73%), 182 headache/dizziness (21.95%), 138 dyspnea (16.65%), 130 blurred vision (15.68%), and 95 nausea/vomiting (11.46%). Personal protective equipment (PPE) is significantly associated with ORAEs in contaminated areas (P < 0.05). Among non-PPE-related factors, insomnia is associated with the majority of ORAEs in contaminated areas. Significant differences were achieved after organized interventions in the incidence of occupational exposure of HCWs (χ2 = 39.07, P < 0.001) and the prevalence of ORAEs in contaminated areas (χ2 = 22.95, P < 0.001).

During the epidemic period of novel severe respiratory infectious disease, the burden of the ORAEs in contaminated areas and the risk of occupational exposure of HCWs were relatively high. In time, comprehensive and multi-level bundled interventions may help decrease the risk of both ORAEs and occupational exposure.

Intervention time (IT) in response to seizures and adverse events (AEs) have emerged as key elements in epilepsy monitoring unit (EMU) management. We performed an audit of our EMU, focusing on IT and AEs.

We performed a retrospective study on all clinical seizures of admissions over a 1-year period at our Canadian academic tertiary care center’s EMU. This EMU was divided in two subunits: a daytime three-bed epilepsy department subunit (EDU) supervised by EEG technicians and a three-bed neurology ward subunit (NWU) equipped with video-EEG where patients were transferred to for nights and weekends, under nursing supervision. Among 124 admissions, 58 were analyzed. A total of 1293 seizures were reviewed to determine intervention occurrence, IT, and AE occurrence. Seizures occurring when the staff was present at bedside at seizure onset were analyzed separately.

Median IT was 21.0 (11.0–40.8) s. The EDU, bilateral tonic–clonic seizures (BTCS), and the presence of a warning signal were associated with increased odds of an intervention taking place. The NWU, BTCS, and seizure rank (seizures were chronologically ordered by the patient for each subunit) were associated with longer ITs. Bedside staff presence rate was higher in the EDU than in the NWU (p < 0.001). AEs occurred in 19% of admissions, with no difference between subunits. AEs were more frequent in BTCS than in other seizure types (p = 0.001).

This study suggests that close monitoring by trained staff members dedicated to EMU patients is key to optimize safety. AE rate was high, warranting corrective measures.

Extracorporeal membrane oxygenation (ECMO) has accelerated rapidly for patients in severe cardiac or respiratory failure. As a result, ECMO networks are being developed across the world using a “hub and spoke” model. Current guidelines call for all patients transported on ECMO to be accompanied by a physician during transport. However, as ECMO centers and networks grow, the increasing number of transports will be limited by this mandate.

The aim of this study was to compare rates of adverse events occurring during transport of ECMO patients with and without an additional clinician, defined as a physician, nurse practitioner (NP), or physician assistant (PA).

This is a retrospective cohort study of all adults transported while cannulated on ECMO from 2011-2018 via ground and air between 21 hospitals in the northeastern United States, comparing transports with and without additional clinicians. The primary outcome was the rate of major adverse events, and the secondary outcome was minor adverse events.

Over the seven-year study period, 93 patients on ECMO were transported. Twenty-three transports (24.7%) were accompanied by a physician or other additional clinician. Major adverse events occurred in 21.5% of all transports. There was no difference in the total rate of major adverse events between accompanied and unaccompanied transports (P = .91). Multivariate analysis did not demonstrate any parameter as being predictive of major adverse events.

In a retrospective cohort study of transports of ECMO patients, there was no association between the overall rate of major adverse events in transport and the accompaniment of an additional clinician. No variables were associated with major adverse events in either cohort.

Given the significant health effects, we assessed geospatial patterns of adverse events (AEs), defined as physical or sexual abuse and accidents or poisonings at home, among children in a mixed rural–urban community.

We conducted a population-based cohort study of children (<18 years) living in Olmsted County, Minnesota, to assess geographic patterns of AEs between April 2004 and March 2009 using International Classification of Diseases, Ninth Revision codes. We identified hotspots by calculating the relative difference between observed and expected case densities accounting for population characteristics ($$Relative\;Difference = {\rm{ }}{{Observed\;Case\;Density - Expected\;Case\;Density} \over {Expected\;Case\;Density}}$$; hotspot ≥ 0.33) using kernel density methods. A Bayesian geospatial logistic regression model was used to test for association of subject characteristics (including residential features) with AEs, adjusting for age, sex, and socioeconomic status (SES).

Of the 30,227 eligible children (<18 years), 974 (3.2%) experienced at least one AE. Of the nine total hotspots identified, five were mobile home communities (MHCs). Among non-Hispanic White children (85% of total children), those living in MHCs had higher AE prevalence compared to those outside MHCs, independent of SES (mean posterior odds ratio: 1.80; 95% credible interval: 1.22–2.54). MHC residency in minority children was not associated with higher prevalence of AEs. Of addresses requiring manual correction, 85.5% belonged to mobile homes.

MHC residence is a significant unrecognized risk factor for AEs among non-Hispanic, White children in a mixed rural–urban community. Given plausible outreach difficulty due to address discrepancies, MHC residents might be a geographically underserved population for clinical care and research.