ABSTRACT
Introduction: Dialectical Behavior Therapy (DBT) aims to decrease emotional dysregulation, particularly through psychoeducation groups targeting skills learning. In March 2020, the confinement due to COVID-19 abruptly interrupted these groups. We continued skills training through YouTube videos. Our objective is to evaluate the feasibility of this format during the confinement. Method(s): All the participants in the DBT skills group carried out in Strasbourg were included (n = 37). The psychoeducational videos were published biweekly during the confinement on the YouTube channel "GREMO HUS". Participants were encouraged to view these videos by calls/messages. One month after the end of the confinement, an online questionnaire assessed satisfaction. Result(s): In total, 92% of patients responded. Of the 34 respondents, 28 (82%) had watched at least one video, and 32% had watched more than 6 videos. A very large majority of users were satisfied with the videos. Seventy-nine percent said they were very helpful in understanding the skills, and 77% thought they had used the DBT skills more frequently. All but one said that the skills helped them to overcome difficulties in times of confinement. Discussion(s): Our study is the first to interview patients directly regarding DBT YouTube videos. These videos were considered relevant by participants during the confinement period. Their use could compliment DBT skills training groups, and serve as a training support for therapists.Copyright © 2021 Elsevier Masson SAS
ABSTRACT
Summary Background: During the COVID-19 pandemic, platform trials with a flexible, adaptive design have emerged as an important study design for randomised controlled trials (RCTs) to provide timely, robust findings on new interventions based on large numbers of participants. Since Germany has often been criticised for deficits in clinical research during the pandemic, we compared the study landscape of various countries during the pandemic. Method(s): ClinicalTrials.gov, the U.S. National Library of Medicine's central trial registry and the Cochrane COVID-19 trial registry were searched for interventional RCTs and platform studies on COVID-19 up to 8 February 2022. The results on number, status, number of participants and funding of the countries were compared. Result(s): A total of 1,246 interventional RCTs and 45 platform studies were registered in Germany, France, UK, US and Australia until February 2022. Germany coordinated only a small proportion of initiated trials. In Germany, one RCT per 1 million inhabitants has been identified;whereas more than twice as many have been identified in France and the US. About a quarter of the RCTs initiated in Germany with >500 participants were completed. In the US, 99 % were completed. One platform study per 100 million inhabitants was initiated in Germany, six in US, eleven in Australia and UK and 18 in France. Conclusion(s): Compared to other countries, Germany initiated fewer interventional RCTs and platform studies during the pandemic. The results from platform studies formed a relevant basis for evidence-based recommendations on interventions to treat COVID-19. Germany contributed little evidence to COVID-19 guidelines. Copyright © 2022 DIOmed Verlags GmbH. All rights reserved.
ABSTRACT
Background: Thromboembolic events are common complications of COVID- 19. Study results on the safety and efficacy of thromboprophylaxis or anticoagulation in COVID-19 are controversial. This review with random-effects meta-analyses systematically summarises the current evidence. Method(s): We included randomised controlled trials (RCTs) published until February 2022 that investigated standard thromboprophylaxis or anticoagulation at any dosage with thromboprophylaxis or no prophylaxis in COVID-19 patients. Relevant outcomes were mortality, clinical status, thrombotic events or death and (severe) bleeding (28 days). Certainty of evidence was assessed according to GRADE (Grading of Recommendations Assessment, Development and Evaluation). Result(s): We included 13 RCTs with 7,364 patients. Two studies investigated thromboprophylaxis versus placebo in COVID-19 outpatients;three studies compared intermediate-dose and seven therapeutic-dose anticoagulation with standard thromboprophylaxis in hospitalised COVID-19 patients;one study investigated post-discharge thromboprophylaxis versus no prophylaxis. We are uncertain whether thromboprophylaxis is beneficial over placebo or no thromboprophylaxis in outpatient- or post-discharge-settings. Intermediatedose anticoagulation is not capable of reducing thrombotic events or death (RR 1.03, 95 % CI 0.86 - 1.24), but is associated with an increase of severe bleedings (non-significant) (RR 1.48, 95 % CI 0.53 - 4.15). Therapeutic-dose anticoagulation may decrease thrombotic events or deaths in patients with moderate COVID-19 (RR 0.64, 95 % CI 0.38-1.07;fixed-effect meta-analysis RR 0.72, 95 % CI 0.57 - 0.91) but showed no effect in patients with severe disease (RR 0.98, 95 % CI 0.86 - 1.12). The risk of severe bleeding may increase regardless of disease severity (RR 1.78, 95 % CI 1.15 - 2.74). Conclusion(s): Certainty of evidence is low. Hospitalised, moderately-ill COVID-19 patients may benefit from therapeutic-dose anticoagulation, however, with an increased risk of bleeding. Copyright © 2022 DIOmed Verlags GmbH. All rights reserved.
ABSTRACT
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. To assess the efficacy and safety of nirmatrelvir/ritonavir (Paxlovid®) plus standard of care compared to standard of care with or without placebo, or any other proven intervention for treating COVID-19 and for preventing SARS-CoV-2 infection.
ABSTRACT
Introduction: Dialectical Behavior Therapy (DBT) aims to decrease emotional dysregulation, particularly through psychoeducation groups targeting skills learning. In March 2020, the confinement due to COVID-19 abruptly interrupted these groups. We continued skills training through YouTube videos. Our objective is to evaluate the feasibility of this format during the confinement. Method: All the participants in the DBT skills group carried out in Strasbourg were included (n = 37). The psychoeducational videos were published biweekly during the confinement on the YouTube channel “GREMO HUS”. Participants were encouraged to view these videos by calls/messages. One month after the end of the confinement, an online questionnaire assessed satisfaction. Results: In total, 92% of patients responded. Of the 34 respondents, 28 (82%) had watched at least one video, and 32% had watched more than 6 videos. A very large majority of users were satisfied with the videos. Seventy-nine percent said they were very helpful in understanding the skills, and 77% thought they had used the DBT skills more frequently. All but one said that the skills helped them to overcome difficulties in times of confinement. Discussion: Our study is the first to interview patients directly regarding DBT YouTube videos. These videos were considered relevant by participants during the confinement period. Their use could compliment DBT skills training groups, and serve as a training support for therapists.
ABSTRACT
Background In a context of a rapid emerging disease, like the COVID-19 pandemic, we are confronted with clinical uncertainty, evolving epidemiological setting and lacking evidence. Within the context of such a high-priority topic, living systematic reviews (LSRs) are an important systematic review type characterized through regular updating and permanent surveillance of continuously evolving evidence. However, with the new pandemic-related challenges, the standard LSR methodology had to be adapted. Objectives The objective is to discuss certain challenges that occurred when conducting LSRs in a rapidly emerging disease context. In particular, we give insights in the lessons we have learned from the conduct of two COVID-19 LSRs and highlight emerging methodological aspects. Results With the evolving knowledge around the virus and its caused disease, we learned that the initial plan for inclusion of study designs, publication types, interventions and comparators, outcomes and the search strategy had to be adapted. The author teams for example had to revise outcome measures or included observational data in addition to evidence from randomized controlled trials, as they provided substantial information on the safety of investigated interventions. For deciding when to update a LSR, additional aspects, such as policy relevance or waiting for important evidence dependent on the individual research question were considered. To avoid biases in the review process, we learned that transparent reporting of any methodological adaptations is highly relevant;between protocol and review, as well as between each review update. Conclusions Our experience showed that LSRs are highly suitable in a pandemic context, in particular when facing unexpected methodological and clinical challenges. The research question, study designs and the methodology, should be revisited and critically discussed before each update, to be flexible enough for addressing the pandemic context. Key messages Living systematic reviews are highly relevant in a pandemic context, but the methodology and decision when to update the review have to be adapted to respond purposeful to the emerging topic. To avoid biases in the review process, we learned that transparent reporting of any methodological adaptations is highly relevant;between protocol and review, as well as between each review update.
ABSTRACT
The use of psychotropics during the COVID-19 pandemic has raised two questions, in order of importance: first, what changes should be made to pharmacological treatments prescribed to mental health patients? Secondly, are there any positive side effects of these substances against SARS-CoV-2? Our aim was to analyze usage safety of psychotropics during COVID-19; therefore, herein, we have studied: (i) the risk of symptomatic complications of COVID-19 associated with the use of these drugs, notably central nervous system activity depression, QTc interval enlargement and infectious and thromboembolic complications; (ii) the risk of mistaking the iatrogenic impact of psychotropics with COVID-19 symptoms, causing diagnostic error. Moreover, we provided a summary of the different information available today for these risks, categorized by mental health disorder, for the following: schizophrenia, bipolar disorder, anxiety disorder, ADHD, sleep disorders and suicidal risk. The matter of psychoactive substance use during the pandemic is also analyzed in this paper, and guideline websites and publications for psychotropic treatments in the context of COVID-19 are referenced during the text, so that changes on those guidelines and eventual interaction between psychotropics and COVID-19 treatment medication can be reported and studied. Finally, we also provide a literature review of the latest known antiviral properties of psychotropics against SARS-CoV-2 as complementary information.