Mirroring everyday clinical practice in clinical trial design: a new concept to improve the external validity of randomized double-blind placebo-controlled trials in the pharmacological treatment of major depression

Background: Randomized, double-blind, placebo-controlled trials constitute the gold standard in clinical research when testing the efficacy of new psychopharmacological interventions in the treatment of major depression. However, the blinded use of placebo has been found to influence clinical trial outcomes and may bias patient selection. Discussion: To improve clinical trial design in major depression so as to reflect clinical practice more closely we propose to present patients with a balanced view of the benefits of study participation irrespective of their assignment to placebo or active treatment. In addition every participant should be given the option to finally receive the active medication. A research agenda is outlined to evaluate the impact of the proposed changes on the efficacy of the drug to be evaluated and on the demographic and clinical characteristics of the enrollment fraction with regard to its representativeness of the eligible population. Summary: We propose a list of measures to be taken to improve the external validity of double-blind, placebocontrolled trials in major depression. The recommended changes to clinical trial design may also be relevant for other psychiatric as well as medical disorders in which expectations regarding treatment outcome may affect the outcome itself

Long-range temporal correlations of broadband EEG oscillations for depressed subjects following different hemispheric cerebral infarction

Abnormal long-range temporal correlation (LRTC) in EEG oscillation has been observed in several brain pathologies and mental disorders. This study examined the relationship between the LRTC of broadband EEG oscillation and depression following cerebral infarction with different hemispheric lesions to provide a novel insight into such depressive disorders. Resting EEGs of 16 channels in 18 depressed (9 left and 9 right lesions) and 21 non-depressed (11 left and 10 right lesions) subjects following cerebral infarction and 19 healthy control subjects were analysed by means of detrended fluctuation analysis, a quantitative measurement of LRTC. The difference among groups and the correlation between the severity of depression and LRTC in EEG oscillation were investigated by statistical analysis. The results showed that LRTC of broadband EEG oscillations in depressive subjects was still preserved but attenuated in right hemispheric lesion subjects especially in left pre-frontal and right inferior frontal and posterior temporal regions. Moreover, an association between the severity of psychiatric symptoms and the attenuation of the LRTC was found in frontal, central and temporal regions for stroke subjects with right lesions. A high discriminating ability of the LRTC in the frontal and central regions to distinguish depressive from non-depressive subjects suggested potential feasibility for LRTC as an assessment indicator for depression following right hemispheric cerebral infarction. Different performance of temporal correlation in depressed subjects following the two hemispheric lesions implied complex association between depression and stroke lesion location.</p

A state level analyses of suicide and the COVID-19 pandemic in Mexico

BACKGROUND: While suicide rates in high- and middle-income countries appeared stable in the early stages of the pandemic, we know little about within-country variations. We sought to investigate the impact of COVID-19 on suicide in Mexico’s 32 states and to identify factors that may have contributed to observed variations between states. METHODS: Interrupted time-series analysis to model the trend in monthly suicides before COVID-19 (from Jan 1, 2010, to March 31, 2020), comparing the expected number of suicides derived from the model with the observed number for the remainder of the year (April 1 to December 31, 2020) for each of Mexico’s 32 states. Next, we modeled state-level trends using linear regression to study likely contributing factors at ecological level. RESULTS: Suicide increased slightly across Mexico during the first nine months of the pandemic (RR 1.03; 95%CI 1.01–1.05). Suicides remained stable in 19 states, increase in seven states (RR range: 1.12–2.04) and a decrease in six states (RR range: 0.46–0.88). Suicide RR at the state level was positively associated with population density in 2020 and state level suicide death rate in 2019. CONCLUSIONS: The COVID-19 pandemic had a differential effect on suicide death within the 32 states of Mexico. Higher population density and higher suicide rates in 2019 were associated with increased suicide. As the country struggles to cope with the ongoing pandemic, efforts to improve access to primary care and mental health care services (including suicide crisis intervention services) in these settings should be given priority. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12888-022-04095-8

A narrative review of recent tools and innovations toward automating living systematic reviews and evidence syntheses

Living reviews are an increasingly popular research paradigm. The purpose of a ‘living’ approach is to allow rapid collation, appraisal and synthesis of evolving evidence on an important research topic, enabling timely influence on patient care and public health policy. However, living reviews are time- and resource-intensive. The accumulation of new evidence and the possibility of developments within the review’s research topic can introduce unique challenges into the living review workflow.To investigate the potential of software tools to support living systematic or rapid reviews, we present a narrative review informed by an examination of tools contained on the Systematic Review Toolbox website. We identified 11 tools with relevant functionalities and discuss the important features of these tools with respect to different steps of the living review workflow. Four tools (NestedKnowledge, SWIFT-ActiveScreener, DistillerSR, EPPI-Reviewer) covered multiple, successive steps of the review process, and the remaining tools addressed specific components of the workflow, including scoping and protocol formulation, reference retrieval, automated data extraction, write-up and dissemination of data.We identify several ways in which living reviews can be made more efficient and practical. Most of these focus on general workflow management, or automation through artificial intelligence and machine-learning, in the screening process. More sophisticated uses of automation mostly target living rapid reviews to increase the speed of production or evidence maps to broaden the scope of the map. We use a case study to highlight some of the barriers and challenges to incorporating tools into the living review workflow and processes. These include increased workload, the need for organisation, ensuring timely dissemination and challenges related to the development of bespoke automation tools to facilitate the review process. We describe how current end-user tools address these challenges, and which knowledge gaps remain that could be addressed by future tool development.Dedicated web presences for automatic dissemination of in-progress evidence updates, rather than solely relying on peer-reviewed journal publications, help to make the effort of a living evidence synthesis worthwhile. Despite offering basic living review functionalities, existing end-user tools could be further developed to be interoperable with other tools to support multiple workflow steps seamlessly, to address broader automatic evidence retrieval from a larger variety of sources, and to improve dissemination of evidence between review updates

Criminal Justice System Contacts among Suicide Decedents in Toronto, 1998-2020: An Observational Study: Démêlés avec le système de justice pénale parmi les personnes décédées par suicide à Toronto, entre 1998 et 2020 : Une étude d'observation

ObjectiveThis exploratory correlational study explored the demographic, clinical, and offence-type characteristics of people with documented past-year contact with the criminal justice system (CJS) in Toronto, Canada who died by suicide. We aimed to compare demographic and clinical factors among individuals with CJS contact who died by suicide to those without recorded CJS contact who died by suicide.MethodsCoroners' final death reports from all recorded suicide deaths in Toronto between 1 January 1998 and 31 December 2020 were retrieved by research staff and coded at the Office of the Chief Coroner (OCC) of Ontario. A series of bivariate analyses and binary logistic regression analyses were performed to compare demographic and clinically relevant characteristics between these groups. Descriptive statistics relating to demographic, clinical, and offence-type characteristics were reported.ResultsA total of 5,288 people died by suicide, of whom 251 (4.7% of all suicides) had recorded CJS contact prior to death. Assault, physical assault, impaired driving, serious/death threats, and sexual assault were the most common criminal charges among those in the CJS contact group. When compared with the no recorded CJS contact group, the CJS contact group was slightly younger (M = 40.0, SD = ±13.4 vs. M = 47.5, SD = ±18.1, p < 0.001), had a higher proportion of males (85.6% vs. 69.9%, p < 0.001), more commonly experienced interpersonal (36.3% vs. 14.5%, p < 0.001) and/or relationship break-up/breakdown stressors (16.7% vs. 7.5%, p < 0.001), and substance misuse or substance use disorders (37.5% vs. 18%, p < 0.001).ConclusionsOur findings highlight that younger men with interpersonal stressors and/or substance misuse characterize suicide decedents with recorded CJS contact in Toronto, Canada. Suicide prevention efforts and strategies should consider the profile differences among those navigating the CJS

The Impact of Infectious Disease-Related Public Health Emergencies on Suicide, Suicidal Behavior, and Suicidal Thoughts:A Systematic Review

Background: Infectious disease-related public health emergencies (epidemics) may increase suicide risk, and high-quality evidence is needed to guide an international response. Aims: We investigated the potential impacts of epidemics on suicide-related outcomes. Method: We searched MEDLINE, EMBASE, PsycInfo, CINAHL, Scopus, Web of Science, PsyArXiv, medRxiv, and bioRxiv from inception to May 13–16, 2020. Inclusion criteria: primary studies, reviews, and meta-analyses; reporting the impact of epidemics; with a primary outcome of suicide, suicidal behavior, suicidal ideation, and/or self-harm. Exclusion criteria: not concerned with suicide-related outcomes; not suitable for data extraction. PROSPERO registration: #CRD42020187013. Results: Eight primary papers were included, examining the effects of five epidemics on suicide-related outcomes. There was evidence of increased suicide rates among older adults during SARS and in the year following the epidemic (possibly motivated by social disconnectedness, fears of virus infection, and concern about burdening others) and associations between SARS/Ebola exposure and increased suicide attempts. A preprint study reported associations between COVID-19 distress and past-month suicidal ideation. Limitations: Few studies have investigated the topic; these are of relatively low methodological quality. Conclusion: Findings support an association between previous epidemics and increased risk of suicide-related outcomes. Research is needed to investigate the impact of COVID-19 on suicide outcomes

Suicide risk and prevention during the COVID-19 pandemic

No abstract available

Vernonia cinerea Less. supplementation and strenuous exercise reduce smoking rate: relation to oxidative stress status and beta-endorphin release in active smokers

<p>Abstract</p> <p>Purpose</p> <p>The aim of this study was to evaluate the effects of <it>Vernonia cinerea </it>Less. (VC) supplementation and exercise on oxidative stress biomarkers, beta-endorphin release, and the rate of cigarette smoking.</p> <p>Methods</p> <p>Volunteer smokers were randomly divided into four groups: group 1: VC supplement; group 2: exercise with VC supplement; group 3: exercise; and group 4: control. VC was prepared by wash and dry techniques and taken orally before smoking, matching the frequency of strenuous exercise (three times weekly). Before and after a two month period, exhaled carbon monoxide (CO), blood oxidative stress (malondialdehyde [MDA], nitric oxide [NOx], protein hydroperoxide [PrOOH] and total antioxidant capacity [TAC]), beta-endorphin and smoking rate were measured, and statistically analyzed.</p> <p>Results</p> <p>In Group 1, MDA, PrOOH, and NOx significantly decreased, whereas TAC increased (p < 0.05). In Group 2, MDA and PrOOH decreased (p < 0.05), with no other changes noted (p > 0.05). In Group 3, MDA, PrOOH, NOx, TAC, and beta-endorphin levels increased significantly (p < 0.05). Group 4 showed no change in oxidative stress variables or beta-endorphine levels (p > 0.05). All groups had lower levels of CO after the intervention. The smoking rate for light cigarette decreased in group 2(62.7%), 1(59.52%), 3 (53.57%) and 4(14.04%), whereas in self-rolled cigarettes it decreased in group 1 (54.47%), 3 (42.30%), 2 (40%) and 4 (9.2%).</p> <p>Conclusion</p> <p>Supplementation with <it>Vernonia cinerea </it>Less and exercise provided benefit related to reduced smoking rate, which may be related to oxidaive stress and beta-endorphine levels.</p

Suicide trends in the early months of the COVID-19 pandemic: an interrupted time-series analysis of preliminary data from 21 countries

BackgroundThe COVID-19 pandemic is having profound mental health consequences for many people. Concerns have been expressed that at its most extreme, this may manifest itself in increased suicide rates.MethodsWe sourced real-time suicide data from around the world via a systematic internet search and recourse to our networks and the published literature. We used interrupted time series analysis to model the trend in monthly suicides prior to COVID-19 in each country/area-within-country, comparing the expected number of suicides derived from the model with the observed number of suicides in the early months of the pandemic. Countries/areas-within countries contributed data from at least 1 January 2019 to 31 July 2020 and potentially from as far back as 1 January 2016 until as recently as 31 October 2020. We conducted a primary analysis in which we treated 1 April to 31 July 2020 as the COVID-19 period, and two sensitivity analyses in which we varied its start and end dates (for those countries/areas-within-countries with data beyond July 2020).OutcomesWe sourced data from 21 countries (high income [n=16], upper-middle income [n=5]; whole country [n=10], area(s)-within-the-country [n=11]). In general, there does not appear to have been a significant increase in suicides since the pandemic began in the countries for which we had data. In fact, in a number of countries/areas-within-countries there appears to have been a decrease.InterpretationThis is the first study to examine suicides occurring in the context of the COVID-19 pandemic in multiple countries. It offers a consistent picture, albeit from high- and upper-middle income countries, of suicide numbers largely remaining unchanged or declining in the early months of the pandemic. We need to remain vigilant and be poised to respond if the situation changes as the longer-term mental health and economic impacts of the pandemic unfold