Effect of statins on venous thromboembolic events: a meta-analysis of published and unpublished evidence from randomised controlled trials

Background - It has been suggested that statins substantially reduce the risk of venous thromboembolic events. We sought to test this hypothesis by performing a meta-analysis of both published and unpublished results from randomised trials of statins. Methods and Findings - We searched MEDLINE, EMBASE, and Cochrane CENTRAL up to March 2012 for randomised controlled trials comparing statin with no statin, or comparing high dose versus standard dose statin, with 100 or more randomised participants and at least 6 months' follow-up. Investigators were contacted for unpublished information about venous thromboembolic events during follow-up. Twenty-two trials of statin versus control (105,759 participants) and seven trials of an intensive versus a standard dose statin regimen (40,594 participants) were included. In trials of statin versus control, allocation to statin therapy did not significantly reduce the risk of venous thromboembolic events (465 [0.9%] statin versus 521 [1.0%] control, odds ratio [OR] = 0.89, 95% CI 0.78–1.01, p = 0.08) with no evidence of heterogeneity between effects on deep vein thrombosis (266 versus 311, OR 0.85, 95% CI 0.72–1.01) and effects on pulmonary embolism (205 versus 222, OR 0.92, 95% CI 0.76–1.12). Exclusion of the trial result that provided the motivation for our meta-analysis (JUPITER) had little impact on the findings for venous thromboembolic events (431 [0.9%] versus 461 [1.0%], OR = 0.93 [95% CI 0.82–1.07], p = 0.32 among the other 21 trials). There was no evidence that higher dose statin therapy reduced the risk of venous thromboembolic events compared with standard dose statin therapy (198 [1.0%] versus 202 [1.0%], OR = 0.98, 95% CI 0.80–1.20, p = 0.87). Risk of bias overall was small but a certain degree of effect underestimation due to random error cannot be ruled out. Please see later in the article for the Editors' Summary. Conclusions - The findings from this meta-analysis do not support the previous suggestion of a large protective effect of statins (or higher dose statins) on venous thromboembolic events. However, a more moderate reduction in risk up to about one-fifth cannot be ruled out

Operationalizing NIMH Research Domain Criteria (RDoC) in naturalistic clinical settings

Recently, the National Institute of Mental Health (NIMH) introduced the Research Domain Criteria (RDoC) initiative to address two major challenges facing the field of psychiatry: (1) the lack of new effective personalized treatments for psychiatric disorders, and (2) the limitations associated with categorically-defined psychiatric disorders. While the potential of RDoC to revolutionize personalized psychiatric medicine and psychiatric nosology has been acknowledged, it is unclear how to implement RDoC in naturalistic clinical settings as part of routine outcomes research. In this paper we present the major RDoC principles and then show how these principles are operationalized in the Menninger Clinic’s McNair Initiative for Neuroscience Discovery-Menninger & Baylor College of Medicine (MIND-MB) study. We discuss how RDoC-informed outcomes-based assessment in clinical settings can transform personalized clinical care through multimodal treatments

Secukinumab demonstrates superiority over narrow-band ultraviolet B phototherapy in new-onset moderate to severe plaque psoriasis patients: Week 52 results from the STEPIn study.

Biologic treatments have been studied mainly in patients with a long-term history of psoriasis and previous treatment failures. The purpose of this primary analysis of the STEPIn study is to determine whether early intervention with secukinumab in patients with new-onset moderate to severe plaque psoriasis is superior to standard of care treatment with narrow band ultraviolet B (nb-UVB) phototherapy. The STEPIn study is a randomized, open-label, multicentre study to investigate early intervention with 52 weeks of secukinumab 300 mg administered subcutaneously versus standard treatment with nb-UVB phototherapy in patients with new-onset (≤12 months) moderate to severe plaque psoriasis (NCT03020199). The primary and additional secondary endpoints were ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) at Week 52 and Investigator's Global Assessment (IGA mod 2011) 0/1 response at Week 52, respectively. In the secukinumab and nb-UVB study arms, 77/80 and 76/80 randomized patients received at least one dose of study treatment, respectively. The primary endpoint was achieved: 91.1% (70/77) of patients achieved a PASI 90 response at Week 52 in the secukinumab arm versus 42.3% (32/76) in the nb-UVB arm (p < 0.0001, odds ratio [OR] estimate [95% confidence intervals, CI] = 16.3 [5.6, 46.9]). The additional secondary endpoint was also achieved: 85.7% of patients achieved an IGA 0/1 response at Week 52 in the secukinumab arm versus 36.8% in the nb-UVB arm (p < 0.0001). The safety data were consistent with the safety profiles of secukinumab and nb-UVB with no new or unexpected safety signals. Secukinumab was superior to nb-UVB in treating patients with new-onset moderate to severe plaque psoriasis. The high and sustained skin clearance observed indicates that biologic treatment for psoriasis may be more effective if used early in the disease course

Plasma metabolite profile for primary open-angle glaucoma in three US cohorts and the UK Biobank

Glaucoma is a progressive optic neuropathy and a leading cause of irreversible blindness worldwide. Primary open-angle glaucoma is the most common form, and yet the etiology of this multifactorial disease is poorly understood. We aimed to identify plasma metabolites associated with the risk of developing POAG in a case-control study (599 cases and 599 matched controls) nested within the Nurses' Health Studies, and Health Professionals' Follow-Up Study. Plasma metabolites were measured with LC-MS/MS at the Broad Institute (Cambridge, MA, USA); 369 metabolites from 18 metabolite classes passed quality control analyses. For comparison, in a cross-sectional study in the UK Biobank, 168 metabolites were measured in plasma samples from 2,238 prevalent glaucoma cases and 44,723 controls using NMR spectroscopy (Nightingale, Finland; version 2020). Here we show higher levels of diglycerides and triglycerides are adversely associated with glaucoma in all four cohorts, suggesting that they play an important role in glaucoma pathogenesis

DSM borderline criterion function across age groups: A cross-sectional mixed-method study

DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) Section II criteria for borderline personality disorder (BPD) lack developmental operationalization. The aim of the current study was to evaluate whether DSM criteria operate similarly across adolescents and adults to determine if developmental adjustment for DSM criteria was needed. Three age cohorts were recruited: adolescents (ages 12-17 years; n = 484), young adults (ages 18-25 years; n = 442), and adults (ages ≥26 years; n = 953). The Child Interview for DSM-IV BPD and the Structured Clinical Interview for DSM-IV Axis II disorders were administered to adolescents and adults, respectively. Item response theory methods were used to evaluate differential item (or criterion) functioning (DIF) of BPD criteria across adolescents and adults. Qualitative analyses were then used to evaluate the potential sources of DIF. Item response theory results demonstrated DIF across adolescents and adults for all DSM BPD criteria. Qualitative analyses suggested that the source of DIF was most likely due to rater/interviewer bias. Results furthermore suggested that behavioral criteria may represent the heterotypic features of BPD, while intra- and interpersonal criteria represent the homotypic features of the disorder. The article concludes with recommendations for developmentally informed guidelines for the assessment of BPD

Diffusion of e-health innovations in 'post-conflict' settings: a qualitative study on the personal experiences of health workers.

BACKGROUND: Technological innovations have the potential to strengthen human resources for health and improve access and quality of care in challenging 'post-conflict' contexts. However, analyses on the adoption of technology for health (that is, 'e-health') and whether and how e-health can strengthen a health workforce in these settings have been limited so far. This study explores the personal experiences of health workers using e-health innovations in selected post-conflict situations. METHODS: This study had a cross-sectional qualitative design. Telephone interviews were conducted with 12 health workers, from a variety of cadres and stages in their careers, from four post-conflict settings (Liberia, West Bank and Gaza, Sierra Leone and Somaliland) in 2012. Everett Roger's diffusion of innovation-decision model (that is, knowledge, persuasion, decision, implementation, contemplation) guided the thematic analysis. RESULTS: All health workers interviewed held positive perceptions of e-health, related to their beliefs that e-health can help them to access information and communicate with other health workers. However, understanding of the scope of e-health was generally limited, and often based on innovations that health workers have been introduced through by their international partners. Health workers reported a range of engagement with e-health innovations, mostly for communication (for example, email) and educational purposes (for example, online learning platforms). Poor, unreliable and unaffordable Internet was a commonly mentioned barrier to e-health use. Scaling-up existing e-health partnerships and innovations were suggested starting points to increase e-health innovation dissemination. CONCLUSIONS: Results from this study showed ICT based e-health innovations can relieve information and communication needs of health workers in post-conflict settings. However, more efforts and investments, preferably driven by healthcare workers within the post-conflict context, are needed to make e-health more widespread and sustainable. Increased awareness is necessary among health professionals, even among current e-health users, and physical and financial access barriers need to be addressed. Future e-health initiatives are likely to increase their impact if based on perceived health information needs of intended users

Working alliance and outcome effectiveness in videoconferencing psychotherapy: a systematic review and non-inferiority meta-analysis

Videoconferencing psychotherapy (VCP) – the remote delivery of psychotherapy via secure video link – is an innovative way of delivering psychotherapy, which has the potential to overcome many of the regularly cited barriers to accessing psychological treatment. However, some debate exists as to whether an adequate working alliance can be formed between therapist and client, when therapy is delivered through such a medium. The presented article is a systematic literature review and two meta-analyses aimed at answering the questions: is it possible to develop adequate working alliance in VCP? And is outcome equivalence possible between VCP and face-to-face delivery? Twelve studies were identified which met inclusion/exclusion criteria, all of which demonstrated good working alliance and outcome for VCP. Meta-analyses showed that working alliance in VCP was inferior to face-to-face delivery (standardised mean difference [SMD] = -0.30; 95% confidence interval [CI] [-0.67, 0.07], p = .11; with the lower-bound of the CI extending beyond the non-inferiority margin [-0.50]), but that target symptom reduction was non-inferior (SMD = -0.03; 95% CI [-0.45, 0.40], p = .90; CI within the non-inferiority margin [.50]). These results are discussed and directions for future research recommended

Cervelleite, Ag4TeS: solution and description of the crystal structure

Copyright: Springer-Verlag Wien 2015. This is the final, post refereeing version. You are advised to consult the publisher's version if you wish to cite from it, http://link.springer.com/article/10.1007%2Fs00710-015-0384-