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https://www.readbyqxmd.com/read/28720618/interpretation-of-cis-in-clinical-trials-with-non-significant-results-systematic-review-and-recommendations
#1
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
#2
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
https://www.readbyqxmd.com/read/28698337/protocol-for-a-multicentre-randomised-feasibility-study-evaluating-the-impact-of-a-prognostic-model-for-management-of-blunt-chest-wall-trauma-patients-stumbl-trial
#3
Ceri Battle, Zoe Abbott, Hayley A Hutchings, Claire Oâ Neill, Sam Groves, Alan Watkins, Fiona E Lecky, Sally Jones, James Gagg, Richard Body, Philip A 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...
July 10, 2017: BMJ Open
https://www.readbyqxmd.com/read/28697343/redefining-hormonal-therapy-for-advanced-prostate-cancer-results-from-the-latitude-and-chaarted-studies
#4
Eric J Small
Two papers published recently in the New England Journal of Medicine describe the utility of abiraterone acetate, an androgen biosynthesis inhibitor, in the early treatment of metastatic prostate cancer. In addition to establishing a new standard of care, these two articles pose a number of important questions for future investigation.
July 10, 2017: Cancer Cell
https://www.readbyqxmd.com/read/28678600/discussing-the-predictive-prognostic-and-therapeutic-value-of-germline-dna-repair-gene-mutations-in-metastatic-prostate-cancer-patients
#5
Ralph J Hauke, Tristan M Sissung, William D Figg
Recent trends in cancer therapy have begun emphasizing the use of precision medicine, especially genetic tools, in the evaluation of malignancies and decision-making. Prostate cancer is a malignancy where the benefits and utility of screening and early treatment are still heavily controversial. A recent paper in the New England Journal of Medicine found that patients with metastatic prostate cancer presented germline mutations in DNA-repair genes at a significantly higher incidence than those with localized prostate cancer...
July 5, 2017: Cancer Biology & Therapy
https://www.readbyqxmd.com/read/28675916/-termination-of-reimbursement-of-arthroscopy-in-osteoarthritis-of-the-knee-is-this-decision-based-on-scientific-grounds
#6
Thoralf Randolph Liebs, Steffen Berger
Background In Germany, arthroscopy of the knee used to be an accepted procedure in the treatment of osteoarthritis of the knee. However, as of April 1, 2016 reimbursement for this procedure has been discontinued. This was a decision of the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA). That decision was based on a report of the German Institute for Quality and Efficiency in Health Care (IQWiG). This report is essentially based on a few studies, three of which have been published in the renowned New England Journal of Medicine...
July 4, 2017: Zeitschrift Für Orthopädie und Unfallchirurgie
https://www.readbyqxmd.com/read/28674135/mechanism-evaluation-of-a-lifestyle-intervention-for-patients-with-musculoskeletal-pain-who-are-overweight-or-obese-protocol-for-a-causal-mediation-analysis
#7
Hopin Lee, John Wiggers, Steven J Kamper, Amanda Williams, Kate M O'Brien, Rebecca K Hodder, Luke Wolfenden, Sze Lin Yoong, Elizabeth Campbell, Robin Haskins, Emma K Robson, James H McAuley, Christopher M Williams
INTRODUCTION: Low back pain (LBP) and knee osteoarthritis (OA) are highly prevalent and disabling conditions that cause societal and economic impact worldwide. Two randomised controlled trials (RCTs) will evaluate the effectiveness of a multicomponent lifestyle intervention for patients with LBP and knee OA who are overweight or obese. The key targets of this intervention are to improve physical activity, modify diet and correct pain beliefs. These factors may explain how a lifestyle intervention exerts its effects on key patient-relevant outcomes: pain, disability and quality of life...
July 3, 2017: BMJ Open
https://www.readbyqxmd.com/read/28659198/-henry-beecher-and-medical-science-the-50th-anniversary-of-a-famous-article
#8
N Jacobs, F G Huisman
In 2016, it had been exactly half a century ago that Henry Beecher published his article 'Ethics and clinical research' in The New England Journal of Medicine. Today, this article is considered a turning point in the history of medical research ethics. On the occasion of the fiftieth anniversary of this famous article, we are looking back on this turbulent period in the history of medicine.
2017: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/28645976/a-combined-randomised-and-observational-study-of-surgery-for-fractures-in-the-distal-radius-in-the-elderly-crossfire-a-study-protocol
#9
Ian A Harris, Justine M Naylor, Andrew Lawson, Rachelle Buchbinder, Rebecca Ivers, Zsolt Balogh, Paul Smith, Rajat Mittal, Wei Xuan, Kirsten Howard, Arezoo Vafa, Piers Yates, Bertram Rieger, Geoff Smith, Ilia Elkinson, Woosung Kim, Mellick Chehade, Jai Sungaran, Kim Latendresse, James Wong, Sameer Viswanathan, Martin Richardson, Kush Shrestha, Herwig Drobetz, Phong Tran, Jeremy Loveridge, Richard Page, Raphael Hau, Roger Bingham, Jonathan Mulford, Ian Incoll
Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28638708/citation-classics-in-central-nervous-system-inflammatory-demyelinating-disease
#10
Jee-Eun Kim, Kang M Park, Yerim Kim, Dae Y Yoon, Jong S Bae
OBJECTIVES: To identify and analyze the characteristics of the most influential articles about central nervous system (CNS) inflammatory demyelinating disease. MATERIALS AND METHODS: The Institute for Scientific Information (ISI) Web of Science database and the 2014 Journal Citation Reports Science Edition were used to retrieve the top 100 cited articles on CNS inflammatory demyelinating disease. The citation numbers, journals, years of publication, authorships, article types, subjects and main issues were analyzed...
June 2017: Brain and Behavior
https://www.readbyqxmd.com/read/28580651/data-fabrication-and-other-reasons-for-non-random-sampling-in-5087-randomised-controlled-trials-in-anaesthetic-and-general-medical-journals
#11
J B Carlisle
Randomised, controlled trials have been retracted after publication because of data fabrication and inadequate ethical approval. Fabricated data have included baseline variables, for instance, age, height or weight. Statistical tests can determine the probability of the distribution of means, given their standard deviation and the number of participants in each group. Randomised, controlled trials have been retracted after the data distributions have been calculated as improbable. Most retracted trials have been written by anaesthetists and published by specialist anaesthetic journals...
June 4, 2017: Anaesthesia
https://www.readbyqxmd.com/read/28515198/post-authorisation-passive-enhanced-safety-surveillance-of-seasonal-influenza-vaccines-protocol-of-a-pilot-study-in-england
#12
Simon de Lusignan, Gaël Dos Santos, Ana Correa, François Haguinet, Ivelina Yonova, Florence Lair, Rachel Byford, Filipa Ferreira, Karen Stuttard, Tom Chan
AIM: To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season's vaccine. STUDY DESIGN: A prospective passive enhanced safety surveillance combining data collection from adverse drug reaction (ADR) cards with automated collection of pseudonymised routinely collected electronic health record (EHR) data...
May 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28493948/gender-bias-in-clinical-case-reports-a-cross-sectional-study-of-the-big-five-medical-journals
#13
Pascale Allotey, Caitlin Allotey-Reidpath, Daniel D Reidpath
BACKGROUND: Gender bias in medical journals can affect the science and the benefit to patients. It has never been investigated in clinical case reports. The oversight is important because of the role clinical case reports play in hypothesis generation and medical education. We investigated contemporary gender bias in case reports for the highest ranked journals in general and internal medicine. METHODS: PubMed case reports data from 2011 to 2016 were extracted for the Annals of Internal Medicine, British Medical Journal, the Journal of the American Medical Association, The Lancet, and New England Journal of Medicine...
2017: PloS One
https://www.readbyqxmd.com/read/28475407/diagnosis-staging-and-risk-stratification-in-prostate-cancer-utilizing-diagnostic-tools-to-avoid-unnecessary-therapies-and-side-effects
#14
Louis Rodgers, Cody J Peer, William D Figg
A lack of appropriate diagnostic tools for prostate cancer has led to overdiagnosis and over treatment. In a recent publication in the New England Journal of Medicine, Hamdy et al showed no difference in the outcomes of patients that had undergone either radical prostatectomy, radiotherapy, or active monitoring. In an effort to enhance clinical stratification, the development of improved, more accurate diagnostic tools is actively being pursued. Herein, we explore recent advances in prostate cancer screening, including biomarker assays, genetic testing, and specialized fields, such as mathematical oncology...
May 5, 2017: Cancer Biology & Therapy
https://www.readbyqxmd.com/read/28435812/scientometrics-on-public-health-research-in-iran-increase-of-area-studies-despite-embargoes-a-review-article
#15
REVIEW
Brice Poreau
BACKGROUND: Due to embargoes and sanctions from 1979 until 2015, impact on scientific research in Iran may be critical. Public health is the main example of this burning point. In this paper, the aim was to map the scientific research in public health in Iran until 2014 with area studies as well as networks of countries involved. METHODS: We used bibliographic analyses using VOS viewer software for network analysis during the period 1975-2014. Two databases were used: Web of Science and PubMed...
March 2017: Iranian Journal of Public Health
https://www.readbyqxmd.com/read/28425136/molecularisation-and-metaphor
#16
David Armstrong
This article explores the molecularisation of medicine thesis by investigating reports on genetics and molecular medicine in the New England Journal of Medicine. While there has indeed been a large increase in the number of references to molecules in the context of genetics over the last few decades these are mostly embedded in a framework of explanatory metaphors, namely (gene) expressivity, penetrance, regulation and pathways. As most of these metaphors are drawn from the social world it would appear that the molecularisation thesis - that social life is becoming dominated by the molecular - needs to be tempered by the ways in which understanding of that molecular world is itself a reflection of social life...
April 20, 2017: Sociology of Health & Illness
https://www.readbyqxmd.com/read/28421497/chapter-13-human-ovarian-tissue-vitrification
#17
Sherman Silber
Ovarian freezing and transplantation has garnered increasing interest as a potential way of preserving fertility in cancer patients as well as for women who just wish to delay childbearing. This chapter spells out our techniques of ovarian cortex vitrification and results for frozen compared to fresh ovarian cortex transplantation (in one single series from one center for the sake of consistency), as well as potentially provides insight into the mechanism behind ovarian follicle recruitment. This represents an effort to simplify and popularize an approach that has yielded favorable results (all cases recovered ovulation and 75% had successful spontaneous pregnancy) in one single, disciplined study...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28401819/-a-plea-for-selective-use-of-the-mammaprint-test
#18
M de Boer, A C Voogd, V C G Tjan-Heijnen
Recently, the results of the MINDACT study were published in The New England Journal of Medicine. The authors conclude that the MammaPrint test can prevent the use of chemotherapy in about 50% of breast cancer patients with a high-risk clinical profile because of the presence of a genomic low risk MammaPrint. We believe that the decision to use chemotherapy should not be based solely on the outcome of the MammaPrint test, as is suggested by the authors, but also on clinical factors, such as tumour size, nodal status and grade...
2017: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/28400294/the-distribution-of-p-values-in-medical-research-articles-suggested-selective-reporting-associated-with-statistical-significance
#19
Thomas V Perneger, Christophe Combescure
OBJECTIVES: Published P-values provide a window into the global enterprise of medical research. The aim of this study was to use the distribution of published P-values to estimate the relative frequencies of null and alternative hypotheses and to seek irregularities suggestive of publication bias. STUDY DESIGN AND SETTING: This cross-sectional study included P-values published in 120 medical research articles in 2016 (30 each from the BMJ, JAMA, Lancet, and New England Journal of Medicine)...
April 9, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28397649/support-and-assessment-for-fall-emergency-referrals-safer-2-a-cluster-randomised-trial-and-systematic-review-of-clinical-effectiveness-and-cost-effectiveness-of-new-protocols-for-emergency-ambulance-paramedics-to-assess-older-people-following-a-fall-with-referral
#20
Helen A Snooks, Rebecca Anthony, Robin Chatters, Jeremy Dale, Rachael Fothergill, Sarah Gaze, Mary Halter, Ioan Humphreys, Marina Koniotou, Phillipa Logan, Ronan Lyons, Suzanne Mason, Jon Nicholl, Julie Peconi, Ceri Phillips, Judith Phillips, Alison Porter, A Niroshan Siriwardena, Graham Smith, Alun Toghill, Mushtaq Wani, Alan Watkins, Richard Whitfield, Lynsey Wilson, Ian T Russell
BACKGROUND: Emergency calls are frequently made to ambulance services for older people who have fallen, but ambulance crews often leave patients at the scene without any ongoing care. We evaluated a new clinical protocol which allowed paramedics to assess older people who had fallen and, if appropriate, refer them to community-based falls services. OBJECTIVES: To compare outcomes, processes and costs of care between intervention and control groups; and to understand factors which facilitate or hinder use...
March 2017: Health Technology Assessment: HTA
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