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Richard S Finkel, Kathie M Bishop, Robert M Nelson
The natural history of spinal muscular atrophy type I (SMA-I) has changed as improved medical support has become available. With investigational drugs for spinal muscular atrophy now in clinical trials, efficient trial design focuses on enrolling recently diagnosed infants, providing best available supportive care, and minimizing subject variation. The quandary has arisen whether it is ethically appropriate to specify a predefined level of nutritional and/or ventilation support for spinal muscular atrophy type I subjects while participating in these studies...
October 19, 2016: Journal of Child Neurology
Leila Rooshenas, Daisy Elliott, Julia Wade, Marcus Jepson, Sangeetha Paramasivan, Sean Strong, Caroline Wilson, David Beard, Jane M Blazeby, Alison Birtle, Alison Halliday, Chris A Rogers, Rob Stein, Jenny L Donovan
BACKGROUND: Randomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians' difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians' reported intentions compared with their actual practices...
October 2016: PLoS Medicine
G Testa, E C Koon, L Johannesson
The uterus is the most recent addition to the list of organs that can be successfully transplanted in humans. This paper analyzes living donor uterus transplantation according to the ethical principle of equipoise. A comparison is made between living donor uterus transplantation and gestational surrogate motherhood. Both are solutions to absolute uterine infertility that allow the transfer of genetic material from intended parents to a child. The analysis concludes that living donor uterus transplantation does not violate the ethical principle of equipoise and should be considered an ethically acceptable solution to absolute uterine infertility...
October 18, 2016: American Journal of Transplantation
K A Lee, C O'Sullivan, P Daly, J Pears, C Owens, B Timmermann, C Ares, S E Combs, D Indelicato, M Capra
BACKGROUND: Proton therapy (PT) is a radiotherapy treatment modality that uses protons, rather than conventional photons. PT is often used in paediatric oncology due to its reported capability to reduce acute and late adverse treatment effects. As PT is unavailable in Ireland, patients are referred abroad for treatment. AIMS: To: (1) produce a descriptive study of Irish children referred abroad for PT, and (2) discuss the case for PT in general. METHODS: A retrospective review of all children referred for PT before October 2015 was performed...
October 15, 2016: Irish Journal of Medical Science
Jan H Cornel, George L Bakris, Susanna R Stevens, Michael Alvarsson, Willem A Bax, Lee-Ming Chuang, Samuel S Engel, Renato D Lopes, Darren K McGuire, Axel Riefflin, Helena Wachslicht Rodbard, Isaac Sinay, Tsvetalina Tankova, Julio Wainstein, Eric D Peterson, Rury R Holman
OBJECTIVE: To evaluate chronic kidney disease (CKD) and cardiovascular outcomes in TECOS (Clinical trial reg. no. NCT00790205, participants with type 2 diabetes and cardiovascular disease treated with sitagliptin, a dipeptidyl peptidase 4 inhibitor, according to baseline estimated glomerular filtration rate (eGFR). RESEARCH DESIGN AND METHODS: We used data from 14,671 TECOS participants assigned in a double-blind design to receive sitagliptin or placebo added to existing therapy, while aiming for glycemic equipoise between groups...
October 14, 2016: Diabetes Care
Joseph Scharpf, Michael Tuttle, Richard Wong, Drew Ridge, Russell Smith, Dana Hartl, Robert Levine, Gregory Randolph
This American Head and Neck Society (AHNS) consensus statement focuses on the detection and management of recurrent thyroid cancer. This document describes the radiologic approach to defining structural recurrent disease and the operative and nonoperative rationale in addressing identified structural disease to create equipoise in the personalized treatment strategy for the patient. The recommendations of this AHNS multidisciplinary consensus panel of the American Head and Neck Society are intended to help guide all multidisciplinary clinicians who diagnose or manage adult patients with thyroid cancer...
September 22, 2016: Head & Neck
Rohan D'Souza, Candice K Silversides, Claire McLintock
The prothrombotic state of pregnancy increases the risk of thromboembolic complications and death in women with mechanical heart valves (MHVs). Although it is accepted that these women must be on therapeutic anticoagulation throughout pregnancy, competing maternal and fetal risks, as well as the lack of high-quality data from prospective studies, make the choice of the optimal method of anticoagulation challenging. Vitamin K antagonists (VKAs) are associated with fewer maternal complications, but conversely also the lowest live birth rates as well as warfarin-related embryopathy and fetopathy...
October 5, 2016: Seminars in Thrombosis and Hemostasis
Jodi Taylor, Sarah Black, Stephen J Brett, Kim Kirby, Jerry P Nolan, Barnaby C Reeves, Maria Robinson, Chris A Rogers, Lauren J Scott, Adrian South, Elizabeth A Stokes, Matthew Thomas, Sarah Voss, Sarah Wordsworth, Jonathan R Benger
Health outcomes after out of hospital cardiac arrest (OHCA) are extremely poor, with only 7-9% of patients in the United Kingdom (UK) surviving to hospital discharge. Currently emergency medical services (EMS) use either tracheal intubation or newer supraglottic airway devices (SGAs) to provide advanced airway management during OHCA. Equipoise between the two techniques has led to calls for a well-designed randomised controlled trial. The primary objective of the AIRWAYS-2 trial is to assess whether the clinical effectiveness of the i-gel, a second-generation SGA, is superior to tracheal intubation in the initial airway management of OHCA patients in the UK...
September 30, 2016: Resuscitation
Naomi Kebba, Tom Mwambu, Michael Oketcho, Jonathan Izudi, Ekwaro A Obuku
BACKGROUND: There is clinical equipoise regarding post-operative management of patients with patent ductus arteriosus (PDA) without insertion of a chest drain. This study evaluated post operative outcomes of chest closure with or without a drain following Patent Ductus Arteriosus ligation among childen at Uganda Heart Instritute (UHI). METHODS: This was an open label randomized controlled trial of 62 children 12 years of age and below diagnosed with patent ductus arteriosus at Mulago National Teaching and Referral Hospital, Uganda...
September 29, 2016: BMC Surgery
R J Hardcastle
No abstract text is available yet for this article.
November 2015: Journal of Minimally Invasive Gynecology
Scott M Tintle, Christopher LeBrun, James R Ficke, Benjamin K Potter
Traumatic and trauma-related amputations represent unfortunate sequelae of severe injury, but should not be viewed as a treatment failure and may represent the best reconstructive option for some patients. Lessons from recent military conflicts have guided the evolution of modern surgical techniques and rehabilitation management of this challenging patient population, and treatment at a specialty center may improve patient outcomes. Despite appropriate management, however, surgical complications remain common and revision surgery is often necessary...
October 2016: Journal of Orthopaedic Trauma
John Hilton, Sasha Mazzarello, Dean Fergusson, Anil A Joy, Andrew Robinson, Angel Arnaout, Brian Hutton, Lisa Vandermeer, Mark Clemons
PURPOSE: The current clinical trials development and conduct process is cumbersome and expensive, with the majority of studies focusing on either the development of new agents or new indications for established agents. Unfortunately, research comparing standard-of-care interventions is rarely performed, leaving many important and practical patient-centered questions unanswered. Novel clinical trial methodologies and approaches are needed. METHODS: We have identified simple key components that, when combined, enhance the ability to both perform and increase accrual for studies that compare standard-of-care interventions...
September 20, 2016: Journal of Oncology Practice
Andrew F Auld, Katherine L Fielding, Ankur Gupta-Wright, Stephen D Lawn
Compared with smear microscopy, the Xpert MTB/RIF assay (Xpert), with superior accuracy and capacity to diagnose rifampicin resistance, has advanced TB diagnostic capability. However, recent trials of Xpert impact have not demonstrated reductions in patient morbidity and mortality. We conducted a narrative review of Xpert impact trials to summarize which patient-relevant outcomes Xpert has improved and explore reasons for no observed morbidity or mortality reductions. We searched PubMed, Google Scholar, Cochrane Library and Embase and identified eight trials meeting inclusion criteria: three individually randomized, three cluster-randomized, and two pre-post trials...
August 2016: Transactions of the Royal Society of Tropical Medicine and Hygiene
Alejandro A Rabinstein, Waleed Brinjikji, David F Kallmes
No abstract text is available yet for this article.
September 16, 2016: Circulation Research
Gilbert R Upchurch
No abstract text is available yet for this article.
September 14, 2016: JAMA Surgery
Antoinette de Waha, Sigrid Sandner, Moritz von Scheidt, Andreas Boening, Katharina Koch-Buettner, Dieter Hammel, Rainer Hambrecht, Bernhard C Danner, Friedrich A Schöndube, Gerold Goerlach, Theodor Fischlein, Michael Schmoeckel, Martin Oberhoffer, Rainer Schulz, Thomas Walther, Tibor Ziegelhöffer, Christoph Knosalla, Felix Schönrath, Friedhelm Beyersdorf, Matthias Siepe, Tim Attmann, Martin Misfeld, Friedrich-Wilhelm Mohr, Hans-Hinrich Sievers, Alexander Joost, Leon M Putman, Günther Laufer, Christian Hamm, Uwe Zeymer, Adnan Kastrati, Peter W Radke, Rüdiger Lange, Jochen Cremer, Heribert Schunkert
BACKGROUND: For patients with coronary artery disease undergoing coronary bypass surgery, acetylsalicylic acid (ASA) currently represents the gold standard of antiplatelet treatment. However, adverse cardiovascular event rates in the first year after coronary artery bypass grafting (CABG) still exceed 10%. Graft failure, which is predominantly mediated by platelet aggregation, has been identified as a major contributing factor in this context. Therefore, intensified platelet inhibition is likely to be beneficial...
September 2016: American Heart Journal
Mattias Neyt, Thierry Christiaens, Jacques Demotes, Tom Walley, Frank Hulstaert
AIM: Many questions of relevance to patients/society are not answered by industry-sponsored clinical trials. We consider whether there are benefits to governments in funding practice-oriented clinical trials. METHODOLOGY: A literature search including publications on institutions' websites was performed and supplemented with information gathered from (inter)national stakeholders. RESULTS: Areas were identified where public funding of clinical trials is of importance for society, such as head-to-head comparisons or medical areas where companies have no motivation to invest...
November 2016: Journal of Comparative Effectiveness Research
Doo Sun Sim, Myung Ho Jeong, Youngkeun Ahn, Young Jo Kim, Shung Chull Chae, Taek Jong Hong, In Whan Seong, Jei Keon Chae, Chong Jin Kim, Myeong Chan Cho, Seung-Woon Rha, Jang Ho Bae, Ki Bae Seung, Seung Jung Park
BACKGROUND: The Strategic Reperfusion Early After Myocardial Infarction trial and the French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015 suggested that pharmacoinvasive strategy compares favorably with primary percutaneous coronary intervention (PPCI). We sought to assess the clinical impact of pharmacoinvasive strategy compared with PPCI in real-world patients with ST-segment-elevation myocardial infarction. METHODS AND RESULTS: We used the Korea Acute Myocardial Infarction Registry to identify ST-segment-elevation myocardial infarction patients receiving either pharmacoinvasive strategy defined as fibrinolysis followed by percutaneous coronary intervention (rescue/urgent or routine elective; n=708) or PPCI (n=8878)...
September 2016: Circulation. Cardiovascular Interventions
James L Januzzi
No abstract text is available yet for this article.
August 31, 2016: European Heart Journal
Alik Farber, Robert T Eberhardt
Importance: Chronic critical limb ischemia, marked by intractable lower extremity ischemic rest pain and tissue loss, is a highly morbid condition that leads to the loss of ambulation and decreased quality of life. It is associated with a high risk of limb loss and mortality and presents a significant economic burden to society. Objective: To review the current state of epidemiology, pathophysiology, diagnosis, and treatment of critical limb ischemia. Evidence Review: An extensive literature search of the subject matter was conducted on material published in English between 1980 and 2016; both landmark and recently published articles were evaluated...
August 17, 2016: JAMA Surgery
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