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https://www.readbyqxmd.com/read/29431141/does-tranexamic-acid-lead-to-changes-in-mri-measures-of-brain-tissue-health-in-patients-with-spontaneous-intracerebral-haemorrhage-protocol-for-a-mri-substudy-nested-within-the-double-blind-randomised-controlled-tich-2-trial
#1
Rob A Dineen, Stefan Pszczolkowski, Katie Flaherty, Zhe K Law, Paul S Morgan, Ian Roberts, David J Werring, Rustam Al-Shahi Salman, Tim England, Philip M Bath, Nikola Sprigg
OBJECTIVES: To test whether administration of the antifibrinolytic drug tranexamic acid (TXA) in patients with spontaneous intracerebral haemorrhage (SICH) leads to increased prevalence of diffusion-weighted MRI-defined hyperintense ischaemic lesions (primary hypothesis) or reduced perihaematomal oedema volume, perihaematomal diffusion restriction and residual MRI-defined SICH-related tissue damage (secondary hypotheses). DESIGN: MRI substudy nested within the double-blind randomised controlled Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 trial (ISRCTN93732214)...
February 3, 2018: BMJ Open
https://www.readbyqxmd.com/read/29412437/an-international-position-statement-on-the-management-of-frailty-in-diabetes-mellitus-summary-of-recommendations-2017
#2
A J Sinclair, A Abdelhafiz, T Dunning, M Izquierdo, L Rodriguez Manas, I Bourdel-Marchasson, J E Morley, M Munshi, J Woo, B Vellas
AIM: the the International Position Statement provides the opportunity to summarise all existing clinical trial and best practice evidence for older people with frailty and diabetes. It is the first document of its kind and is intended to support clinical decisions that will enhance safety in management and promote high quality care. METHODS: the Review Group sought evidence from a wide range of studies that provide sufficient confidence (in the absence of grading) for the basis of each recommendation...
2018: Journal of Frailty & Aging
https://www.readbyqxmd.com/read/29329525/reporting-of-heterogeneity-of-treatment-effect-in-cohort-studies-a-review-of-the-literature
#3
Meryl Dahan, Caroline Scemama, Raphael Porcher, David J Biau
BACKGROUND: This article corresponds to a literature review and analyze how heterogeneity of treatment (HTE) is reported and addressed in cohort studies and to evaluate the use of the different measures to HTE analysis. METHODS: prospective cohort studies, in English language, measuring the effect of a treatment (pharmacological, interventional, or other) published among 119 core clinical journals (defined by the National Library of Medicine) in the last 16 years were selected in the following data source: Medline...
January 12, 2018: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/29306063/many-rcts-may-not-be-justified-a-cross-sectional-analysis-of-the-ethics-and-science-of-randomized-clinical-trials
#4
Julie De Meulemeester, Mark Fedyk, Lucas Jurkovic, Michael Reaume, Dar Dowlatshahi, Grant Stotts, Michel Shamy
OBJECTIVE: We have proposed that three scientific criteria are important to the ethical justification of RCTs: (1) they should be designed around a clear hypothesis; (2) uncertainty should exist around that hypothesis; (3) that uncertainty should be as established through a systematic review. We hypothesized that the majority of a sample of recently-published RCTs would not explicitly incorporate these criteria, therefore rendering them potentially unjustified on scientific grounds. STUDY DESIGN AND SETTING: Cross-sectional analysis of all RCTs published in the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA) in 2015...
January 3, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29281975/a-survey-of-prevalence-of-narrative-and-systematic-reviews-in-five-major-medical-journals
#5
Clovis Mariano Faggion, Nikolaos P Bakas, Jason Wasiak
BACKGROUND: Systematic reviews may provide less biased evidence than narrative reviews because they observe a strict methodology, similarly to primary studies. Hence, for clinical research questions, systematic reviews should be the study design of choice. It would be important to evaluate the prevalence and characteristics of narrative and systematic reviews published in prominent medical journals. Researchers and clinicians give great value to articles published in such scientific journals...
December 28, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/29275030/testosterone-and-cardiovascular-health
#6
REVIEW
Andrew Elagizi, Tobias S Köhler, Carl J Lavie
There is an ongoing debate in the medical community regarding the effects of testosterone on cardiovascular (CV) health. For decades, there has been conflicting evidence regarding the association of endogenous testosterone levels and CV disease (CVD) events that has resulted in much debate and confusion among health care providers and patients alike. Testosterone therapy has become increasingly widespread, and after the emergence of studies that reported increased CVD events in patients receiving testosterone therapy, the US Food and Drug Administration (FDA) released a warning statement about testosterone and its potential risk regarding CV health...
December 20, 2017: Mayo Clinic Proceedings
https://www.readbyqxmd.com/read/29239150/gender-differences-in-septic-intensive-care-unit-patients
#7
Francesco Campanelli, Giovanni Landoni, Luca Cabrini, Alberto Zangrillo
BACKGROUND: The world population is mostly male at birth, although there is a shift in predominance over 55 years of age with more females than males. Male gender was recently hypothesized to be a risk factor for sepsis and septic shock; the reasons and the consequences of this odd discrepancy are yet a matter of debate. We investigated the percentage of males and females in a large number of trials performed on septic adult patients admitted to Intensive Care Units. METHODS: We analysed all the multicentre randomized controlled trials ever published in peer-reviewed Journals reporting a significant effect on mortality in intensive care unit septic adult patients; furthermore, we retrieved all the manuscripts dealing with sepsis or septic shock patients published in the last 3 years in the three medical Journals with the highest impact factor...
December 13, 2017: Minerva Anestesiologica
https://www.readbyqxmd.com/read/29221458/a-cohort-examination-to-establish-reporting-of-the-remit-and-function-of-trial-steering-committees-in-randomised-controlled-trials
#8
Elizabeth J Conroy, Barbara Arch, Nicola L Harman, J Athene Lane, Steff C Lewis, John Norrie, Matthew R Sydes, Carrol Gamble
BACKGROUND: The DAMOCLES project established a widely used Data Monitoring Committee (DMC) Charter for randomised controlled trials (RCTs). Typically, within the UK, the DMC is advisory and recommends to another executive body; the Trial Steering Committee (TSC). Despite the executive role of the TSC, the CONSORT Statement does not explicitly require reporting of TSC activity, although is included as an example of good reporting. A lack of guidance on TSC reporting can impact transparency of trial oversight, ultimately leading to a misunderstanding regarding role and, subsequently, further variation in practice...
December 8, 2017: Trials
https://www.readbyqxmd.com/read/29170309/12%C3%A2-a-multi-centre-randomised-feasibility-study-evaluating-the-impact-of-a-prognostic-model-for-management-of-blunt-chest-wall-trauma-patients-stumbl-trial
#9
Ceri Battle, Hayley Hutchings, Zoe Abbott, Claire O'neill, Sam Groves, Alan Watkins, Fiona Lecky, Sally Jones, James Gagg, Rick Body, Phillip Evans
INTRODUCTION: A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the Emergency Department (ED). A definitive randomised controlled trial (impact trial), is required to assess the clinical and cost effectiveness of the new model, before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design...
December 2017: Emergency Medicine Journal: EMJ
https://www.readbyqxmd.com/read/29161267/sugar-industry-sponsorship-of-germ-free-rodent-studies-linking-sucrose-to-hyperlipidemia-and-cancer-an-historical-analysis-of-internal-documents
#10
Cristin E Kearns, Dorie Apollonio, Stanton A Glantz
In 1965, the Sugar Research Foundation (SRF) secretly funded a review in the New England Journal of Medicine that discounted evidence linking sucrose consumption to blood lipid levels and hence coronary heart disease (CHD). SRF subsequently funded animal research to evaluate sucrose's CHD risks. The objective of this study was to examine the planning, funding, and internal evaluation of an SRF-funded research project titled "Project 259: Dietary Carbohydrate and Blood Lipids in Germ-Free Rats," led by Dr...
November 2017: PLoS Biology
https://www.readbyqxmd.com/read/29149153/analysis-of-reporting-bias-in-vertebral-augmentation
#11
Douglas P Beall, Sean M Tutton, Kieran Murphy, Wayne Olan, Christopher Warner, Jack B Test
Osteoporotic vertebral compression fractures (OVCFs) are a significant cause of morbidity and mortality in the United States and worldwide, with estimates of 750,000 to 1.5 million occurring annually. As the elderly population continues to increase, the incidence of OVCFs will continue to rise, as will the morbidity and mortality associated with this condition. Vertebral augmentation (VA) was almost universally accepted as the appropriate treatment modality prior to 2 sham trials published in 2009 by the New England Journal of Medicine (NEJM)...
November 2017: Pain Physician
https://www.readbyqxmd.com/read/29101129/dissemination-of-2014-dual-antiplatelet-therapy-dapt-trial-results-a-systematic-review-of-scholarly-and-media-attention-over-7-months
#12
Melissa K Sharp, Romana Haneef, Philippe Ravaud, Isabelle Boutron
OBJECTIVE: To explore how the results from the 2014 dual antiplatelet therapy (DAPT) trial were disseminated to the scientific community and online media. DESIGN: A a systematic review of scholarly and public attention surrounding the DAPT study. SETTINGS: Data were collected from the ISI Web of Knowledge, Google Scholar, PubMed Commons, EurekAlert, the DAPT study website (www.daptstudy.org) and the New England Journal of Medicine website (for scholarly attention) and Altmetric Explorer, Snap Bird, YouTube (for public attention) citing DAPT study results appearing from 16 November 2014 to 10 June 2015...
November 3, 2017: BMJ Open
https://www.readbyqxmd.com/read/29100609/economic-evaluations-of-alcohol-prevention-interventions-is-the-evidence-sufficient-a-review-of-methodological-challenges
#13
REVIEW
Sarah R Hill, Luke Vale, David Hunter, Emily Henderson, Yemi Oluboyede
Public health interventions have unique characteristics compared to health technologies, which present additional challenges for economic evaluation (EE). High quality EEs that are able to address the particular methodological challenges are important for public health decision-makers. In England, they are even more pertinent given the transition of public health responsibilities in 2013 from the National Health Service to local government authorities where new agents are shaping policy decisions. Addressing alcohol misuse is a globally prioritised public health issue...
October 27, 2017: Health Policy
https://www.readbyqxmd.com/read/29070642/exploring-the-theory-barriers-and-enablers-for-patient-and-public-involvement-across-health-social-care-and-patient-safety-a-protocol-for-a-systematic-review-of-reviews
#14
Josephine Ocloo, Sarah Garfield, Shoba Dawson, Bryony Dean Franklin
INTRODUCTION: The emergence of patient and public involvement (PPI) in healthcare in the UK can be traced as far back as the 1970s. More recently, campaigns by harmed patients and their relatives have emerged as a result of clinical failings in the NHS, challenging paternalistic healthcare, which have led to a new focus on PPI in quality and safety, nationally and internationally. Evidence suggests that PPI within patient safety is often atheoretical and located within a biomedical discourse...
October 24, 2017: BMJ Open
https://www.readbyqxmd.com/read/29058806/an-epidemic-of-multiple-sclerosis-and-falling-infection-rates-reflecting-on-comparisons-made-and-the-rising-multiple-sclerosis-incidence-in-bach-s-2002-new-england-journal-of-medicine-figure
#15
H Tremlett, R Lucas
BACKGROUND AND PURPOSE: We set out to revisit and comment on the evidence surrounding a popular figure published in the New England Journal of Medicine (2002), which suggests that the incidence of immune-mediated diseases, including multiple sclerosis (MS), is increased by reduced exposure to infections. METHODS: Commentary. RESULTS: We found that, to date (May 2017), this influential article has been cited >2000 times. However, on close investigation of the figure, we noticed some problems...
January 2018: European Journal of Neurology: the Official Journal of the European Federation of Neurological Societies
https://www.readbyqxmd.com/read/28993088/hip-and-knee-arthroplasty-orthopedic-literature-in-medical-journals-is-it-negatively-biased
#16
Ronald E Delanois, Chukwuweike U Gwam, Nicolas S Piuzzi, Morad Chughtai, Arthur L Malkani, Peter M Bonutti, Michael A Mont
BACKGROUND: Healthcare policy is often determined by well-designed studies most often published in high-impact medical journals. However, concern about the presence of publication bias against lower-extremity arthroplasty-related studies has called into question some of the validity of certain reports. There are only a few studies investigating the presence of the bias in high-impact medical journals against lower-extremity arthroplasty intervention, particularly in the Journal of American Medical Association (JAMA), New England Journal of Medicine (NEJM), and the Lancet...
September 19, 2017: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28967862/provision-of-information-about-newborn-screening-antenatally-a-sequential-exploratory-mixed-methods-project
#17
Fiona Ulph, Stuart Wright, Nimarta Dharni, Katherine Payne, Rebecca Bennett, Stephen Roberts, Kieran Walshe, Tina Lavender
BACKGROUND: Participation in the UK Newborn Bloodspot Screening Programme (NBSP) requires parental consent but concerns exist about whether or not this happens in practice and the best methods and timing to obtain consent at reasonable cost. OBJECTIVES: To collate all possible modes of prescreening communication and consent for newborn (neonatal) screening (NBS); examine midwives', screening professionals' and users' views about the feasibility, efficiency and impact on understanding of each; measure midwives' and parents' preferences for information provision; and identify key drivers of cost-effectiveness for alternative modes of information provision...
October 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28749016/trends-in-study-design-and-the-statistical-methods-employed-in-a-leading-general-medicine-journal
#18
M Gosho, Y Sato, K Nagashima, S Takahashi
WHAT IS KNOWN AND OBJECTIVE: Study design and statistical methods have become core components of medical research, and the methodology has become more multifaceted and complicated over time. The study of the comprehensive details and current trends of study design and statistical methods is required to support the future implementation of well-planned clinical studies providing information about evidence-based medicine. Our purpose was to illustrate study design and statistical methods employed in recent medical literature...
July 27, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/28720618/interpretation-of-cis-in-clinical-trials-with-non-significant-results-systematic-review-and-recommendations
#19
Jennifer S Gewandter, Michael P McDermott, Rachel A Kitt, Jenna Chaudari, James G Koch, Scott R Evans, Robert A Gross, John D Markman, Dennis C Turk, Robert H Dworkin
OBJECTIVES: Interpretation of CIs in randomised clinical trials (RCTs) with treatment effects that are not statistically significant can distinguish between results that are 'negative' (the data are not consistent with a clinically meaningful treatment effect) or 'inconclusive' (the data remain consistent with the possibility of a clinically meaningful treatment effect). This interpretation is important to ensure that potentially beneficial treatments are not prematurely abandoned in future research or clinical practice based on invalid conclusions...
July 18, 2017: BMJ Open
https://www.readbyqxmd.com/read/28718304/the-role-of-surgery-in-low-grade-gliomas-do-timing-and-extent-of-resection-matter
#20
Hugues Duffau
Hugues Duffau is a Professor and Chairman of the Neurosurgery Department in the Montpellier University Medical Center and Head of the INSERM 1051 Team "plasticity of the central nervous system, human stem cells and glial tumors" at the Institute for Neurosciences of Montpellier (France). He is an expert in the awake cognitive neurosurgery of slow-growing brain tumors, such as low-grade gliomas, a routine which he has developed since 20 years. His fundamental approach is centered on the concepts of the brain connectomics and neuroplasticity, breaking with the traditional localizationist view of cerebral processing...
July 18, 2017: CNS Oncology
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