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https://www.readbyqxmd.com/read/29329525/reporting-of-heterogeneity-of-treatment-effect-in-cohort-studies-a-review-of-the-literature
#1
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/29320658/osimertinib-as-first-line-treatment-in-egfr-mutated-non-small-cell-lung-cancer
#2
EDITORIAL
Sanjay Popat
New England Journal of Medicine, Volume 378, Issue 2, Page 192-193, January 2018.
January 11, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29320655/ivf-transfer-of-fresh-or-frozen-embryos-in-women-without-polycystic-ovaries
#3
Lan N Vuong, Vinh Q Dang, Tuong M Ho, Bao G Huynh, Duc T Ha, Toan D Pham, Linh K Nguyen, Robert J Norman, Ben W Mol
BACKGROUND: Among women who are undergoing in vitro fertilization (IVF), the transfer of frozen embryos has been shown to result in a higher rate of live birth than the transfer of fresh embryos in those with infertility associated with the polycystic ovary syndrome. It is not known whether frozen-embryo transfer results in similar benefit in women with infertility that is not associated with the polycystic ovary syndrome. METHODS: We randomly assigned 782 infertile women without the polycystic ovary syndrome who were undergoing a first or second IVF cycle to receive either a frozen embryo or a fresh embryo on day 3...
January 11, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29320654/immune-related-adverse-events-associated-with-immune-checkpoint-blockade
#4
Michael A Postow, Robert Sidlow, Matthew D Hellmann
New England Journal of Medicine, Volume 378, Issue 2, Page 158-168, January 2018.
January 11, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29320652/multiple-sclerosis
#5
Daniel S Reich, Claudia F Lucchinetti, Peter A Calabresi
New England Journal of Medicine, Volume 378, Issue 2, Page 169-180, January 2018.
January 11, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29320647/long-term-effects-of-inhaled-budesonide-for-bronchopulmonary-dysplasia
#6
Dirk Bassler, Eric S Shinwell, Mikko Hallman, Pierre-Henri Jarreau, Richard Plavka, Virgilio Carnielli, Christoph Meisner, Corinna Engel, Alexander Koch, Karen Kreutzer, Johannes N van den Anker, Matthias Schwab, Henry L Halliday, Christian F Poets
BACKGROUND: The long-term effects on neurodevelopment of the use of inhaled glucocorticoids in extremely preterm infants for the prevention or treatment of bronchopulmonary dysplasia are uncertain. METHODS: We randomly assigned 863 infants (gestational age, 23 weeks 0 days to 27 weeks 6 days) to receive early (within 24 hours after birth) inhaled budesonide or placebo. The prespecified secondary long-term outcome was neurodevelopmental disability among survivors, defined as a composite of cerebral palsy, cognitive delay (a Mental Development Index score of <85 [1 SD below the mean of 100] on the Bayley Scales of Infant Development, Second Edition, with higher scores on the scale indicating better performance), deafness, or blindness at a corrected age of 18 to 22 months...
January 11, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29320646/transfer-of-fresh-versus-frozen-embryos-in-ovulatory-women
#7
Yuhua Shi, Yun Sun, Cuifang Hao, Heping Zhang, Daimin Wei, Yunshan Zhang, Yimin Zhu, Xiaohui Deng, Xiujuan Qi, Hong Li, Xiang Ma, Haiqin Ren, Yaqin Wang, Dan Zhang, Bo Wang, Fenghua Liu, Qiongfang Wu, Ze Wang, Haiyan Bai, Yuan Li, Yi Zhou, Mei Sun, Hong Liu, Jing Li, Lin Zhang, Xiaoli Chen, Songying Zhang, Xiaoxi Sun, Richard S Legro, Zi-Jiang Chen
BACKGROUND: Elective frozen-embryo transfer has been shown to result in a higher live-birth rate than fresh-embryo transfer among anovulatory women with the polycystic ovary syndrome. It is uncertain whether frozen-embryo transfer increases live-birth rates among ovulatory women with infertility. METHODS: In this multicenter, randomized trial, we randomly assigned 2157 women who were undergoing their first in vitro fertilization cycle to undergo either fresh-embryo transfer or embryo cryopreservation followed by frozen-embryo transfer...
January 11, 2018: New England Journal of Medicine
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
#8
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
#9
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
#10
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
#11
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/29236642/noninvasive-cardiac-radiation-for-ablation-of-ventricular-tachycardia
#12
Phillip S Cuculich, Matthew R Schill, Rojano Kashani, Sasa Mutic, Adam Lang, Daniel Cooper, Mitchell Faddis, Marye Gleva, Amit Noheria, Timothy W Smith, Dennis Hallahan, Yoram Rudy, Clifford G Robinson
BACKGROUND: Recent advances have enabled noninvasive mapping of cardiac arrhythmias with electrocardiographic imaging and noninvasive delivery of precise ablative radiation with stereotactic body radiation therapy (SBRT). We combined these techniques to perform catheter-free, electrophysiology-guided, noninvasive cardiac radioablation for ventricular tachycardia. METHODS: We targeted arrhythmogenic scar regions by combining anatomical imaging with noninvasive electrocardiographic imaging during ventricular tachycardia that was induced by means of an implantable cardioverter-defibrillator (ICD)...
December 14, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29236639/a-bivalent-meningococcal-b-vaccine-in-adolescents-and-young-adults
#13
RANDOMIZED CONTROLLED TRIAL
Lars Ostergaard, Timo Vesikari, Judith Absalon, Johannes Beeslaar, Brian J Ward, Shelly Senders, Joseph J Eiden, Kathrin U Jansen, Annaliesa S Anderson, Laura J York, Thomas R Jones, Shannon L Harris, Robert O'Neill, David Radley, Roger Maansson, Jean-Louis Prégaldien, John Ginis, Nina B Staerke, John L Perez
BACKGROUND: MenB-FHbp is a licensed meningococcal B vaccine targeting factor H-binding protein. Two phase 3 studies assessed the safety of the vaccine and its immunogenicity against diverse strains of group B meningococcus. METHODS: We randomly assigned 3596 adolescents (10 to 18 years of age) to receive MenB-FHbp or hepatitis A virus vaccine and saline and assigned 3304 young adults (18 to 25 years of age) to receive MenB-FHbp or saline at baseline, 2 months, and 6 months...
December 14, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29236632/noninvasive-ablation-of-ventricular-tachycardia
#14
EDITORIAL
Roy M John, William G Stevenson
New England Journal of Medicine, Volume 377, Issue 24, Page 2388-2390, December 2017.
December 14, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29236630/kidney-diseases-associated-with-human-immunodeficiency-virus-infection
#15
REVIEW
Scott D Cohen, Jeffrey B Kopp, Paul L Kimmel
New England Journal of Medicine, Volume 377, Issue 24, Page 2363-2374, December 2017.
December 14, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29228640/comparison-of-primary-endpoints-between-publications-registries-and-protocols-of-phase-iii-cancer-clinical-trials
#16
Fei Liang, Xinmei Guo, Sheng Zhang, Hongxi Xue, Qiang Chen, Xichun Hu
Background: Decisions by leading journals to require trial registration and to make protocols of phase III randomized clinical trials (RCTs) publicly accessible were landmark events in clinical trial reporting. Materials and Methods: We identified phase III cancer RCTs published between 2013 and 2015 in New England Journal of Medicine (NEJM), The Lancet, The lancet Oncology, JAMA and Journal of Clinical Oncology (JCO). Results: We identified 345 reports of phase III RCTs of which 217 (62...
November 14, 2017: Oncotarget
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
#17
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
#18
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
#19
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. W...
November 2017: PLoS Biology
https://www.readbyqxmd.com/read/29153075/is-whole-colon-investigation-by-colonoscopy-computerised-tomography-colonography-or-barium-enema-necessary-for-all-patients-with-colorectal-cancer-symptoms-and-for-which-patients-would-flexible-sigmoidoscopy-suffice-a-retrospective-cohort-study
#20
Wendy Atkin, Kate Wooldrage, Urvi Shah, Kate Skinner, Jeremy P Brown, Willie Hamilton, Ines Kralj-Hans, Michael R Thompson, Karen G Flashman, Steve Halligan, Siwan Thomas-Gibson, Margaret Vance, Amanda J Cross
BACKGROUND: For patients referred to hospital with suspected colorectal cancer (CRC), it is current standard clinical practice to conduct an examination of the whole colon and rectum. However, studies have shown that an examination of the distal colorectum using flexible sigmoidoscopy (FS) can be a safe and clinically effective investigation for some patients. These findings require validation in a multicentre study. OBJECTIVES: To investigate the links between patient symptoms at presentation and CRC risk by subsite, and to provide evidence of whether or not FS is an effective alternative to whole-colon investigation (WCI) in patients whose symptoms do not suggest proximal or obstructive disease...
November 2017: Health Technology Assessment: HTA
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