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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
#1
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
#2
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
#3
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/29149153/analysis-of-reporting-bias-in-vertebral-augmentation
#4
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
#5
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
#6
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
#7
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-ms-incidence-in-bach-s-nejm-2002-figure
#8
Helen Tremlett, Robyn Lucas
Myths are common in science and research. Findings from a publication in a high impact, influential journal, can be accepted as fact, with an assumption that the peer review process ensures study validity. Repeated presentation of graphical representations or summary statements at scientific meetings and through citation in publications can cement the findings such that they guide 'understanding' of science and future research directions. Such may be the case with the multiple sclerosis (MS) related epidemiology presented within a wider review article published in 2002 in the New England Journal of Medicine (NEJM)...
October 23, 2017: 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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
Ceri Battle, Zoe Abbott, Hayley A Hutchings, Claire O'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/28674135/mechanism-evaluation-of-a-lifestyle-intervention-for-patients-with-musculoskeletal-pain-who-are-overweight-or-obese-protocol-for-a-causal-mediation-analysis
#15
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/28645976/a-combined-randomised-and-observational-study-of-surgery-for-fractures-in-the-distal-radius-in-the-elderly-crossfire-a-study-protocol
#16
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/28515198/post-authorisation-passive-enhanced-safety-surveillance-of-seasonal-influenza-vaccines-protocol-of-a-pilot-study-in-england
#17
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/28435812/scientometrics-on-public-health-research-in-iran-increase-of-area-studies-despite-embargoes-a-review-article
#18
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/28421497/chapter-13-human-ovarian-tissue-vitrification
#19
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/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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