Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial

OBJECTIVES: Objective 1: To determine if it is feasible to conduct an RCT of online Sudarshan Kriya Yoga (SKY) for frontline hospital and long-term care home staff under the constraints imposed by the COVID-19 pandemic and need for remote trial monitoring. Objective 2: To assess whether online versions of SKY and/or Health Enhancement Program (HEP) result in improvement in self-rated measures of insomnia, anxiety, depression, and resilience. TRIAL DESIGN: This is an open-label feasibility randomized controlled trial (RCT), comparing an online breath based yogic intervention SKY versus an online control mind-body intervention HEP in frontline hospital and long-term care home staff managing the COVID-19 pandemic. PARTICIPANTS: Participants will include frontline hospital and long-term care home staff that are involved in the management of COVID-19 patients in London, Ontario, Canada. Participants will be willing and able to attend via online video conferencing software to participate in the study interventions. Participants must have an adequate understanding of English and be able to sit without physical discomfort for 60 minutes. INTERVENTION AND COMPARATOR: Sudarshan Kriya Yoga (SKY): The online version of SKY will be delivered by at least one certified Canadian SKY teacher, with at least one back up teacher at all times, under the supervision of Ms. Ronnie Newman, Director of Research and Health Promotion, Art of Living Foundation, USA. The online version of SKY for healthcare workers has a total duration of 3 hours. Phase I will consist of 5 self-paced online modules of 4-10 minutes each to learn the breath control techniques. Participants will be sent an online survey in REDCap requesting that they self-confirm completion of the Phase I modules. In Phase II, 2 interactive online sessions of 1 hour each will be held on consecutive days with a certified SKY teacher, during which participants will learn the fast, medium and slow breaths. For ease of scheduling, multiple time windows will be offered for Phase II. There will be at least one back up teacher at all times. Both Phase I and II will be completed in the first week. Health Enhancement Program (HEP): The active control arm, HEP, will consist of time-matched online self-paced modules for Phase I. Phase II will consist of mindfulness-based meditation sessions delivered by mental health staff. HEP will be an active treatment program that incorporates mind-body interventions. HEP will consist of time-matched online self-paced modules with psychoeducation on healthy active living as well as interactive modules comprising of guided de-stressing exercises including music therapy, mindfulness and progressive muscle relaxation. Weekly follow up sessions will be offered to all recruited participants for 30 minutes each for the subsequent 4 weeks in both study arms. MAIN OUTCOMES: The following feasibility outcomes will be measured at the end of the study: (1) rate of participant recruitment, (2) rate of retention, (3) completeness of data entry, (4) cost of interventions, and (5) unexpected costs. Such measures will be collected on a daily basis through-out the study and tabulated 5 weeks later at the end of the study. RANDOMISATION: Participants will be randomized after they have electronically signed the consent form and the research staff have confirmed eligibility. We will use REDCap to perform randomization in a 1:1 ratio as well as allocation concealment. REDCap is widely used by health researchers worldwide to significantly reduce data entry and study management errors to improve data fidelity. BLINDING (MASKING): All study participants will be blinded to the study hypotheses so as to prevent any expectation bias. Group allocation will be masked during analysis. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): This study will randomize a total of 60 participants in a 1:1 ratio to either SKY or HEP interventions. TRIAL STATUS: Protocol version number 2.0 (June 5, 2020). Recruitment is currently ongoing (starting June 25, 2020). We anticipate to complete recruitment by June 30, 2021 and complete the study by September 30, 2021. TRIAL REGISTRATION: ClinicalTrials.gov protocol ID NCT04368676 (posted April 30, 2020). FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol

Cognitive Outcomes following Transcatheter Aortic Valve Implantation: A Systematic Review

Severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and contributes to a large proportion of all deaths over the age of 70. Severe aortic stenosis is conventionally treated with surgical aortic valve replacement; however, the less invasive transcatheter aortic valve implantation (TAVI) is suggested for those at high surgical risk. While TAVI has been associated with improved survival and favourable outcomes, there is a higher incidence of cerebral microembolisms in TAVI patients. This finding is of concern given mechanistic links with cognitive decline, a symptom highly prevalent in those with cardiovascular disease. This paper reviews the literature assessing the possible link between TAVI and cognitive changes. Studies to date have shown that global cognition improves or remains unchanged over 3 months following TAVI while individual cognitive domains remain preserved over time. However, the association between TAVI and cognition remains unclear due to methodological limitations. Furthermore, while these studies have largely focused on memory, cognitive impairment in this population may be predominantly of vascular origin. Therefore, cognitive assessment focusing on domains important in vascular cognitive impairment, such as executive dysfunction, may be more helpful in elucidating the association between TAVI and cognition in the long term.Peer Reviewe

Mind-Body Interventions for Depressive Symptoms in Chronic Pain: A Systematic Review of Meta-Analyses

Background: Psychological comorbidities in chronic pain (CP) are common and contribute to adverse health outcomes and poor quality of life. Evidence-based guidance for the management of depressive symptoms in CP is limited, particularly for mind-body interventions. Objectives: To investigate the effectiveness of mind-body interventions for the management of depressive symptoms in people with CP. Study Design: Systematic review (SR) of SRs. Setting: SRs with meta-analyses of clinical interventions for the management of depressive symptoms in people with CP. Methods: This SR was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Electronic searches were performed for MEDLINE, EMBASE, PsycINFO, CINAHL, AMED, the Cochrane Database of Systematic Reviews, and the Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports from inception to March 14, 2019. Reference lists and overviews were also hand-searched. SRs of mind-body interventions for CP were included if they conducted a meta-analysis of depression outcomes in people with any CP type not including headache. Two independent reviewers screened, extracted, and evaluated the quality of articles found. Quality was assessed using the AMSTAR 2 criteria and data were summarized narratively with standardized mean differences and 95% confidence intervals of the depression outcome. Results: Eleven SRs with 20 distinct meta-analyses demonstrated a small to moderate beneficial effect for mind-body interventions (effect sizes: -0.05 to -0.63). Limitations: Depressive symptomatology was a subordinate concern compared with other outcomes. The primary literature base was reasonably broad with 33 primary studies, but small when compared with the number of meta-analyses. Conclusions: Mind-body interventions show consistent small to moderate effects in reducing depressive symptoms in CP. The literature in this area demonstrates understudy and oversynthesis. There is a need for more clinical trials focusing on people with axial pain, people with comorbid major depressive disorder, and with depression as the primary outcome of interest. Full SR registered on PROSPERO: CRD42019131871

Examining the feasibility and effectiveness of case manager delivered problem-solving therapy on late-life depression in a real-world setting: a mixed design pilot study

To optimize outcomes in Late-Life Depression (LLD), there remains a need for innovative augmentation treatments. Problem-Solving Therapy (PST) is demonstrated as an effective augmentation psychotherapy for LLD in a one-to-one setting. This study investigated the feasibility of implementing Case Manager delivered group PST for LLD in a community setting. The design was a mixed-methods pilot one-group pre-test post-test quasi-experimental feasibility study in adults aged 60+ years meeting criteria for major depressive disorder (MDD). Feasibility measures were inclusion, attendance, and attrition rate. PST was delivered in groups of 6–9 participants over 8 weeks. Participants completed a weekly self-rated depression scale from weeks 1–8, and pre-and post-intervention rater assessed depression and self-rated assessments of quality of life, insomnia, disability, and anxiety. Focus group interviews took place at week 8 for the first and last study cohort. Twenty-nine participants (inclusion rate of 91%) were enrolled, a recruitment rate of 2.2 participants/month. Of these, 26 (90%) completed week 8 assessments and 25 (96%) attended 5 or more PST sessions, while 15 (58%) attended all sessions. Self-rated depression, anxiety, and insomnia scores decreased significantly with medium-to-large effect sizes, while there was non-significant improvement in rater-assessed depression and self-rated disability and quality of life. Qualitative data showed participants found PST an easy-to-use technique and felt empowered and hopeful in recovering from depression. The results justify a replication of the study in a large RCT exploring the efficacy of offering a group-based Case Manager facilitated PST to older adults with LLD, in a community setting. Clinical Trial Registration Number: NCT03408821</p

Correction to: Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry

International audienceIn this article, the name of the GLORIA-AF investigator Anastasios Kollias was given incorrectly as Athanasios Kollias in the Acknowledgements. The original article has been corrected

Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry

Background: Previous studies suggested potential ethnic differences in the management and outcomes of atrial fibrillation (AF). We aim to analyse oral anticoagulant (OAC) prescription, discontinuation, and risk of adverse outcomes in Asian patients with AF, using data from a global prospective cohort study. Methods: From the GLORIA-AF Registry Phase II-III (November 2011-December 2014 for Phase II, and January 2014-December 2016 for Phase III), we analysed patients according to their self-reported ethnicity (Asian vs. non-Asian), as well as according to Asian subgroups (Chinese, Japanese, Korean and other Asian). Logistic regression was used to analyse OAC prescription, while the risk of OAC discontinuation and adverse outcomes were analysed through Cox-regression model. Our primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACE). The original studies were registered with ClinicalTrials.gov, NCT01468701, NCT01671007, and NCT01937377. Findings: 34,421 patients were included (70.0&nbsp;±&nbsp;10.5 years, 45.1% females, 6900 (20.0%) Asian: 3829 (55.5%) Chinese, 814 (11.8%) Japanese, 1964 (28.5%) Korean and 293 (4.2%) other Asian). Most of the Asian patients were recruited in Asia (n&nbsp;=&nbsp;6701, 97.1%), while non-Asian patients were mainly recruited in Europe (n&nbsp;=&nbsp;15,449, 56.1%) and North America (n&nbsp;=&nbsp;8378, 30.4%). Compared to non-Asian individuals, prescription of OAC and non-vitamin K antagonist oral anticoagulant (NOAC) was lower in Asian patients (Odds Ratio [OR] and 95% Confidence Intervals (CI): 0.23 [0.22-0.25] and 0.66 [0.61-0.71], respectively), but higher in the Japanese subgroup. Asian ethnicity was also associated with higher risk of OAC discontinuation (Hazard Ratio [HR] and [95% CI]: 1.79 [1.67-1.92]), and lower risk of the primary composite outcome (HR [95% CI]: 0.86 [0.76-0.96]). Among the exploratory secondary outcomes, Asian ethnicity was associated with higher risks of thromboembolism and intracranial haemorrhage, and lower risk of major bleeding. Interpretation: Our results showed that Asian patients with AF showed suboptimal thromboembolic risk management and a specific risk profile of adverse outcomes; these differences may also reflect differences in country-specific factors. Ensuring integrated and appropriate treatment of these patients is crucial to improve their prognosis. Funding: The GLORIA-AF Registry was funded by Boehringer Ingelheim GmbH