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Equipoise

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https://www.readbyqxmd.com/read/28034908/targeted-oxygen-in-the-resuscitation-of-preterm-infants-a-randomized-clinical-trial
#1
Ju Lee Oei, Ola D Saugstad, Kei Lui, Ian M Wright, John P Smyth, Paul Craven, Yueping Alex Wang, Rowena McMullan, Elisabeth Coates, Meredith Ward, Parag Mishra, Koert De Waal, Javeed Travadi, Kwee Ching See, Irene G S Cheah, Chin Theam Lim, Yao Mun Choo, Azanna Ahmad Kamar, Fook Choe Cheah, Ahmed Masoud, William Tarnow-Mordi
BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O2) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O2 on the combined risk of death and disability at 2 years in infants <32 weeks' gestation. METHODS: A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission...
January 2017: Pediatrics
https://www.readbyqxmd.com/read/28003553/economics-of-home-monitoring-for-apnea-in-late-preterm-infants
#2
Brian L Montenegro, Michael Amberson, Lauren Veit, Christina Freiberger, Dmitry Dukhovny, Lawrence M Rhein
BACKGROUND: Apnea of prematurity affects a small proportion but large absolute number of late preterm infants, with out-patient management variably utilized despite relative clinical equipoise and potential for improved cost-effectiveness. METHODS: Over a 5-y period, from 2009 to 2013, infants born at ≥34 weeks gestational age at a level IIIB academic center in Boston, Massachusetts, with discharge-delaying apnea, bradycardia, and desaturation (ABD) events were identified...
January 2017: Respiratory Care
https://www.readbyqxmd.com/read/27982726/a-bayesian-analysis-of-a-randomized-clinical-trial-comparing-antimetabolite-therapies-for-non-infectious-uveitis
#3
Erica N Browne, Sivakumar R Rathinam, Anuradha Kanakath, Radhika Thundikandy, Manohar Babu, Thomas M Lietman, Nisha R Acharya
PURPOSE: To conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief. METHODS: A RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan-uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey...
February 2017: Ophthalmic Epidemiology
https://www.readbyqxmd.com/read/27965848/a-feasibility-study-incorporating-a-pilot-randomised-controlled-trial-of-oral-feeding-plus-pre-treatment-gastrostomy-tube-versus-oral-feeding-plus-as-needed-nasogastric-tube-feeding-in-patients-undergoing-chemoradiation-for-head-and-neck-cancer-tube-trial-study
#4
Vinidh Paleri, Joshua Wood, Joanne Patterson, Deborah D Stocken, Mike Cole, Luke Vale, Jeremy Franks, Teresa Guerrero-Urbano, Rachael Donnelly, Stewart Barclay, Tim Rapley, Nikki Rousseau
BACKGROUND: There are 7000 new cases of head and neck squamous cell cancers (HNSCC) treated by the NHS each year. Stage III and IV HNSCC can be treated non-surgically by radio therapy (RT) or chemoradiation therapy (CRT). CRT can affect eating and drinking through a range of side effects with 90 % of patients undergoing this treatment requiring nutritional support via gastrostomy (G) or nasogastric (NG) tube feeding. Long-term dysphagia following CRT is a primary concern for patients...
2016: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/27940456/perioperative-cognitive-protection
#5
C Brown, S Deiner
There is significant evidence that many older surgical patients experience at least a transient decrease in cognitive function. Although there is still equipoise regarding the degree, duration, and mechanism of cognitive dysfunction, there is a concurrent need to provide best-practice clinical evidence. The two major cognitive disorders seen after surgery are postoperative delirium and postoperative cognitive dysfunction. Delirium is a public health problem; millions of dollars are spent annually on delirium-related medical resource use and prolonged hospital stays...
December 2016: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/27907898/obstetrical-and-perinatal-outcomes-following-blastocyst-transfer-compared-to-cleavage-transfer-a-systematic-review-and-meta-analysis
#6
W P Martins, C O Nastri, L Rienzi, S Z van der Poel, C R Gracia, C Racowsky
STUDY QUESTION: Is blastocyst transfer safe when compared to cleavage stage embryo transfer regarding obstetric and perinatal outcomes? SUMMARY ANSWER: The clinical equipoise between blastocyst and cleavage stage embryo transfer remains as the evidence associating blastocyst transfer with some adverse perinatal outcomes is of low/very low quality. WHAT IS KNOWN ALREADY: Extended embryo culture to the blastocyst stage provides some theoretical advantages and disadvantages...
November 2016: Human Reproduction
https://www.readbyqxmd.com/read/27898253/establishing-equipoise-national-survey-of-the-treatment-of-pediatric-para-pneumonic-effusion-and-empyema
#7
Morgan K Richards, Jarod P Mcateer, Todd C Edwards, Lucas R Hoffman, Matthew P Kronman, Dennis W Shaw, Adam B Goldin
BACKGROUND: Despite six randomized trials of various treatments for pediatric para-pneumonic effusion (PPE), management approaches differ. The purpose of this study was to gain insight into opinions on PPE treatment with the goal of designing a definitive trial to generate consensus intervention guidelines. METHODS: To evaluate physician opinions regarding PPE management, we developed a survey based on input from a nationwide, multi-disciplinary advisory group that established content validity...
November 29, 2016: Surgical Infections
https://www.readbyqxmd.com/read/27895301/acute-blood-pressure-management-in-intracerebral-hemorrhage-equipoise-resists-an-attack
#8
Kenneth Butcher, Magdy Selim
No abstract text is available yet for this article.
December 2016: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/27875904/timing-of-rectal-cancer-surgery-following-neoadjuvant-chemoradiation-how-close-are-we-to-striking-an-equipoise
#9
Savio George Barreto, Bhawna Sirohi, Shailesh V Shrikhande
No abstract text is available yet for this article.
November 23, 2016: Future Oncology
https://www.readbyqxmd.com/read/27862965/-thinking-that-somebody-s-going-to-delay-a-tonsillectomy-for-one-to-two-years-is-quite-horrifying-really-a-qualitative-feasibility-study-for-the-national-trial-of-tonsillectomy-in-adults-nattina-part-2
#10
L A McSweeney, J T O'Hara, N S Rousseau, D D Stocken, F Sullivan, L Vale, S Wilkes, J A Wilson, C A Haighton
OBJECTIVES: Level one evidence on the value of adult tonsillectomy versus non-surgical management remains scarce. Before embarking on a costly national randomised controlled trial, it is essential to establish its feasibility. DESIGN: Feasibility study with in-depth qualitative and cognitive interviews. SETTING: ENT staff and patients were recruited from nine hospital centres across England and Scotland. PARTICIPANTS: Patients who were referred for tonsillectomy (n = 15), a convenience sample of general practitioners (n = 11) and ear, nose and throat staff (n = 22)...
October 19, 2016: Clinical Otolaryngology
https://www.readbyqxmd.com/read/27837385/roads-maps-and-destinations-the-journey-of-left-ventricular-assist-device-implantation-in-ambulatory-patients-with-advanced-heart-failure
#11
REVIEW
Barry H Trachtenberg, Jerry D Estep
PURPOSE OF REVIEW: The benefit of left ventricular assist devices in patients dependent on inotropes or temporary mechanical support is clear. There is a large population of advanced heart failure patients who are ambulatory and not dependent on inotropes, but in whom mortality remains high. We review the limited evidence regarding the benefits and risks of LVADs in this population. RECENT FINDINGS: The REVIVE-IT trial, which aimed to study the use of LVADs in patients who are less sick and do not meet current FDA-indications, was suspended due to lack of equipoise in the setting of a spike in pump thromboses...
December 2016: Current Cardiology Reports
https://www.readbyqxmd.com/read/27823685/feasibility-of-a-proposed-randomized-trial-in-patients-with-uncomplicated-descending-thoracic-aortic-dissection-results-of-worldwide-survey
#12
Firas F Mussa, Joseph S Coselli, Kim A Eagle
The trial we propose will be the first multicenter, randomized, trial investigating the role of thoracic endovascular aortic repair (TEVAR) of uncomplicated type B aortic dissection (TBAD) compared to conservative (medical) management. To document the current management approaches for uncomplicated TBAD, we performed an international survey in 130 centers (in US and worldwide), of whom 114 (89%) responded. Sixty-three (54.8%) respondents do not routinely stent uncomplicated TBAD, and 43 (37.4%) perform TEVAR based on various imaging criteria...
November 2016: American Heart Journal
https://www.readbyqxmd.com/read/27809948/antithrombotic-strategy-in-cerebral-venous-thrombosis-differences-between-neurologist-and-hematologist-respondents-in-a-canadian-survey
#13
Thalia S Field, Marie-Christine Camden, Sohaila Al-Shimemeri, Gary Lui, Agnes Y Y Lee
Patterns of practice for management of cerebral venous thrombosis in Canada are unknown. We surveyed Canadian neurologists and hematologists regarding anticoagulation in cerebral venous thrombosis. The response rate was 28%, with 27 neurologists and 20 hematologists responding. We found that choice of first-line initial anticoagulation differed significantly between neurologists and hematologists, with 89% of neurologists favouring unfractionated heparin and hematologists' preference split between unfractionated heparin (50%) and low-molecular-weight heparin (50%)...
January 2017: Canadian Journal of Neurological Sciences. le Journal Canadien des Sciences Neurologiques
https://www.readbyqxmd.com/read/27784670/equipoise-and-the-technology-curve-relevance-in-the-design-of-surgical-trials
#14
EDITORIAL
A H R W Simpson, I R Murray, A D Duckworth
No abstract text is available yet for this article.
October 2016: Bone & Joint Research
https://www.readbyqxmd.com/read/27777297/surgical-management-of-infective-endocarditis-complicated-by-embolic-stroke-practical-recommendations-for-clinicians
#15
Bobby Yanagawa, Gosta B Pettersson, Gilbert Habib, Marc Ruel, Gustavo Saposnik, David A Latter, Subodh Verma
There has been an overall improvement in surgical mortality for patients with infective endocarditis (IE), presumably because of improved diagnosis and management, centered around a more aggressive early surgical approach. Surgery is currently performed in approximately half of all cases of IE. Improved survival in surgery-treated patients is correlated with a reduction in heart failure and the prevention of embolic sequelae. It is reported that between 20% and 40% of patients with IE present with stroke or other neurological conditions...
October 25, 2016: Circulation
https://www.readbyqxmd.com/read/27777269/randomised-placebo-controlled-trials-of-surgery-ethical-analysis-and-guidelines
#16
Julian Savulescu, Karolina Wartolowska, Andy Carr
Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: (1) the presence of equipoise, defined as a lack of unbiased evidence for efficacy of an intervention; (2) clinically important research question; (3) the risk to patients is minimised and reasonable; (4) there is uncertainty about treatment allocation rather than deception; (5) there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and (6) ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool...
October 24, 2016: Journal of Medical Ethics
https://www.readbyqxmd.com/read/27777176/when-should-axillary-drains-be-removed-a-meta-analysis-of-time-limited-versus-volume-controlled-strategies-for-timing-of-drain-removal-following-axillary-lymphadenectomy
#17
David R Thomson, Alexander E J Trevatt, Dominic Furniss
BACKGROUND: Despite numerous studies over the past few decades, the optimum strategy for deciding when to remove drains following axillary lymphadenectomy remains unknown. This meta-analysis aims to compare time-limited and volume-controlled strategies for drain removal. METHODS: A total of 584 titles were identified following a systematic literature search of EMBASE, MEDLINE, Cinahl and the Cochrane library; 6 titles met our eligibility criteria. Data were extracted and independently verified by two authors...
October 5, 2016: Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS
https://www.readbyqxmd.com/read/27776137/dabigatran-for-the-treatment-and-secondary-prevention-of-venous-thromboembolism-a-cost-effectiveness-analysis-for-the-netherlands
#18
J Stevanović, L A de Jong, B S Kappelhoff, E P Dvortsin, M Voorhaar, M J Postma
BACKGROUND: Dabigatran was proven to have similar effect on the prevention of recurrence of venous thromboembolism (VTE) and a lower risk of bleeding compared to vitamin K antagonists (VKA). The aim of this study is to assess the cost-effectiveness (CE) of dabigatran for the treatment and secondary prevention in patients with VTE compared to VKAs in the Dutch setting. METHODS: Previously published Markov model was modified and updated to assess the CE of dabigatran and VKAs for the treatment and secondary prevention in patients with VTE from a societal perspective in the base-case analysis...
2016: PloS One
https://www.readbyqxmd.com/read/27760875/spinal-muscular-atrophy-type-i-is-it-ethical-to-standardize-supportive-care-intervention-in-clinical-trials
#19
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
https://www.readbyqxmd.com/read/27755555/conveying-equipoise-during-recruitment-for-clinical-trials-qualitative-synthesis-of-clinicians-practices-across-six-randomised-controlled-trials
#20
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
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