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Equipoise

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https://www.readbyqxmd.com/read/29341045/approach-to-infants-born-through-meconium-stained-amniotic-fluid-evolution-based-on-evidence
#1
Munmun Rawat, Sushma Nangia, Praveen Chandrasekharan, Satyan Lakshminrusimha
Meconium-stained amniotic fluid (MSAF) during delivery is a marker of fetal stress. Neonates born through MSAF often need resuscitation and are at risk of meconium aspiration syndrome (MAS), air leaks, hypoxic-ischemic encephalopathy, extracorporeal membrane oxygenation (ECMO), and death. The neonatal resuscitation approach to MSAF has evolved over the last three decades. Previously, nonvigorous neonates soon after delivery were suctioned under the vocal cords with direct visualization technique using a meconium aspirator...
January 16, 2018: American Journal of Perinatology
https://www.readbyqxmd.com/read/29326152/decision-analytic-markov-model-weighting-expected-benefits-and-current-limitations-of-first-generation-bioresorbable-vascular-scaffolds-implications-for-manufacturers-and-next-device-iterations
#2
Davide Capodanno, Sergio Buccheri, Sara Romano, Piera Capranzano, Bruno Francaviglia, Corrado Tamburino
BACKGROUND: Relative benefits of bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents (EES) are expected to accrue after complete bioresorption. METHODS AND RESULTS: We built a decision analytic Markov model comparing BVS and EES for a contemporary percutaneous coronary intervention population. Procedure-related morbidity and outcome data from the available literature were used to derive model probabilities. The net benefit of BVS and EES was estimated in terms of quality-adjusted life expectancy...
January 2018: Circulation. Cardiovascular Interventions
https://www.readbyqxmd.com/read/29316960/pregabalin-versus-gabapentin-in-the-treatment-of-sciatica-study-protocol-for-a-randomised-double-blind-cross-over-trial-pagpros
#3
Kelvin Robertson, Laurence A G Marshman, Maria Hennessy, Linton Harriss, David Plummer
BACKGROUND: There is currently an absence of high-grade evidence regarding the treatment of chronic sciatica (CS). Whilst gabapentin (GBP) and pregabalin (PGB) are both currently used to treat CS, equipoise exists regarding their individual use. In particular, no head-to-head study of GBP and PGB in CS exists. Despite equipoise, most countries' formulary regulatory authorities typically favour one drug for subsidy over the other. This hinders interchange wherever the favoured drug is either ineffective or not tolerated...
January 9, 2018: Trials
https://www.readbyqxmd.com/read/29310600/warfarin-anticoagulation-in-hemodialysis-patients-with-atrial-fibrillation-comparison-of-nephrologist-led-and-anticoagulation-clinic-led-management
#4
Hamad Bahbahani, Ahmed AlTurki, Ahmed Dawas, Mark L Lipman
BACKGROUND: There is conflicting evidence of benefit versus harm for warfarin anticoagulation in hemodialysis patients with atrial fibrillation. This equipoise may be explained by suboptimal Time in Therapeutic Range (TTR), which correlates well with thromboembolic and bleeding complications. This study aimed to compare nephrologist-led management of warfarin therapy versus that led by specialized anticoagulation clinic. METHODS: In a retrospective cohort of chronic hemodialysis patients from two institutions (Institution A: Nephrologist-led warfarin management, Institution B: Anticoagulation clinic-led warfarin management), we identified patients with atrial fibrillation who were receiving warfarin for thromboembolic prophylaxis...
January 8, 2018: BMC Nephrology
https://www.readbyqxmd.com/read/29306468/mid-term-outcomes-of-chronic-total-occlusion-percutaneous-coronary-intervention-with-subadventitial-vs-intraplaque-crossing-a-systematic-review-and-meta-analysis
#5
Aris Karatasakis, Barbara A Danek, Judit Karacsonyi, Lorenzo Azzalini, Mauro Carlino, Stéphane Rinfret, Minh Vo, Bavana V Rangan, M N Burke, Subhash Banerjee, Emmanouil S Brilakis
BACKGROUND: Some reports have demonstrated increased risk with subadventitial chronic total occlusion (CTO) crossing, whereas others suggest equipoise between subadventitial and intraplaque crossing techniques. We sought to clarify the effect of subadventitial lesion crossing on mid-term outcomes of CTO percutaneous coronary intervention (PCI). METHODS: We conducted a systematic review and meta-analysis of studies reporting post-discharge outcomes after CTO PCI performed via subadventitial vs...
February 15, 2018: International Journal of Cardiology
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
#6
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/29300977/schemata-consort-and-the-salk-polio-vaccine-trial
#7
Charles J Kowalski, Adam J Mrdjenovich
In this essay, we defend the design of the Salk polio vaccine trial and try to put some limits on the role schemata should play in designing clinical research studies. Our presentation is structured as a response to de Freitas and Pietrobon (de Freitas, R. S. and R. Pietrobon. 2007. Whoever could get rid of the context of discovery/context of justification dichotomy? A proposal based on recent developments in clinical research. Journal of Medicine and Philosophy 32:25-42.) who identified the CONSORT statement as a schema that would have, had it existed at the time, ruled out the design of the Salk polio vaccine trial of 1954 in favor of a completely randomized controlled clinical trial (RCT)...
December 29, 2017: Journal of Medicine and Philosophy
https://www.readbyqxmd.com/read/29290004/a-republican-argument-against-nudging-and-informed-consent
#8
Paul Hamilton
I argue that it is impermissible to use nudges as a tool to influence patients in the context of informed consent. The motivation for such nudges is that their use can help reconcile potential conflicts between a physician's duty of beneficence and duty to respect patient autonomy. I argue that their use places physicians in a position of domination over patients. That is, it violates the republican freedom of patients because it grants physicians the power to arbitrarily interfere. I also argue that if one tries to adjust the duty of beneficence to avoid this conclusion, then the republican freedom of patients is still threatened under conditions of clinical equipoise...
December 30, 2017: HEC Forum: An Interdisciplinary Journal on Hospitals' Ethical and Legal Issues
https://www.readbyqxmd.com/read/29288862/variability-in-surgical-treatment-of-spondylolisthesis-among-spine-surgeons
#9
Daniel Lubelski, Vincent Alentado, Seth Williams, Colin O'Rourke, Nancy Obuchowski, Jeffrey C Wang, Michael Steinmetz, Alfred Melillo, Edward Benzel, Michael Modic, Robert Quencer, Thomas Mroz
BACKGROUND: There are a multitude of treatments for low grade lumbar spondylolisthesis. There are no clear guidelines for the optimal approach. OBJECTIVE: To identify the surgical treatment patterns for spondylolisthesis, among United States spine surgeons METHODS: 445 US spine surgeons completed a survey of clinical/radiographic case scenarios on patients with lumbar spondylolisthesis with neurogenic claudication with (S+BP) or without (S-BP) associated mechanical back pain...
December 27, 2017: World Neurosurgery
https://www.readbyqxmd.com/read/29284666/is-the-concept-of-clinical-equipoise-still-relevant-to-research
#10
Spencer Phillips Hey, Alex John London, Charles Weijer, Annette Rid, Franklin Miller
No abstract text is available yet for this article.
December 28, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29241844/efficacy-and-safety-of-routine-aspiration-thrombectomy-during-primary-pci-for-st-segment-elevation-myocardial-infarction-a-metanalysis-of-large-randomized-controlled-trials
#11
Konstantinos Marmagkiolis, Abdul Hakeem, Mehmet Cilingiroglu, Dmitriy N Feldman, Konstantinos Charitakis
BACKGROUND: Recent randomized controlled trials (RCTs) have questioned the clinical efficacy and even safety of routine aspiration thrombectomy (AT) during primary PCI. A systematic synthesis of these randomized data is hence very timely to address this clinical equipoise. METHODS: We performed a meta-analysis of the larger (>150 patients) Randomized Controlled Trials (RCT) which compared aspiration thrombectomy with primary PCI alone. Procedural end-points were Myocardial Blush Grade (MBG) of 0 or 1 and ST segment resolution (STR) of >50%...
December 11, 2017: Hellenic Journal of Cardiology: HJC, Hellēnikē Kardiologikē Epitheōrēsē
https://www.readbyqxmd.com/read/29236169/current-treatment-of-central-retinal-artery-occlusion-a-national-survey
#12
Teddy S Youn, Patrick Lavin, Morgan Patrylo, Joseph Schindler, Howard Kirshner, David M Greer, Matthew Schrag
BACKGROUND: Central retinal artery occlusion (CRAO) is an ophthalmological emergency, the retinal analog of a stroke. To date there is no consensus or national guidelines on how this disorder should be managed. As academic neurologists and ophthalmologists treat CRAO frequently, we set out to understand how these clinicians approach patients with CRAO with a national survey. METHODS: We identified university-associated teaching hospitals offering vascular neurology, neuro-ophthalmology and/or retina fellowships in the US and asked the directors of the programs to respond to questions in an open response format to profile the acute management of CRAO at their institution...
December 13, 2017: Journal of Neurology
https://www.readbyqxmd.com/read/29233498/proton-pump-inhibitors-and-cardiovascular-events-a-systematic-review
#13
REVIEW
Timothy P Shiraev, Andrew Bullen
BACKGROUND: Proton pump inhibitors (PPIs) are a commonly prescribed medication that recent data has linked to an increased risk of cardiovascular morbidity and all cause morbidity. The current study sought to perform a systematic review to investigate the link between PPIs and morbidity and mortality METHODS: A systematic review was carried out as per the PRISMA guidelines, with information databases including Pubmed, Medline, and the Cochrane Review Database. English-language studies of all types published from January 1990 to October 2016 were considered...
November 20, 2017: Heart, Lung & Circulation
https://www.readbyqxmd.com/read/29229070/infective-endocarditis-an-update-for-dental-surgeons
#14
REVIEW
Andrew Narendran Robinson, Paul Anantharajah Tambyah
Infective endocarditis (IE) is associated with significant morbidity and mortality. The prevention of infective endocarditis, for many years, has involved the identification of at risk patients undergoing medical or dental procedures and the use of pre-procedural antibiotic prophylaxis. However, evidence regarding the effectiveness of such measures is lacking while evidence is mounting for the adverse effects of inappropriate antibiotic use. International guidelines for antibiotic prophylaxis were amended, radically in some cases to reflect this...
December 2017: Singapore Dental Journal
https://www.readbyqxmd.com/read/29225733/colorectal-surgeon-consensus-with-diverticulitis-clinical-practice-guidelines
#15
Javariah Siddiqui, Assad Zahid, Jonathan Hong, Christopher John Young
AIM: To determine the application of clinical practice guidelines for the current management of diverticulitis and colorectal surgeon specialist consensus in Australia and New Zealand. METHODS: A survey was distributed to 205 colorectal surgeons in Australia and New Zealand, using 22 hypothetical clinical scenarios. RESULTS: The response rate was 102 (50%). For 19 guideline-based scenarios, only 11 (58%) reached consensus (defined as > 70% majority opinion) and agreed with guidelines; while 3 (16%) reached consensus and did not agree with guidelines...
November 27, 2017: World Journal of Gastrointestinal Surgery
https://www.readbyqxmd.com/read/29191445/training-health-professionals-to-recruit-into-challenging-randomized-controlled-trials-improved-confidence-the-development-of-the-quintet-rct-recruitment-training-intervention
#16
Nicola Mills, Daisy Gaunt, Jane M Blazeby, Daisy Elliott, Samantha Husbands, Peter Holding, Leila Rooshenas, Marcus Jepson, Bridget Young, Peter Bower, Catrin Tudur Smith, Carrol Gamble, Jenny L Donovan
OBJECTIVE: To describe and evaluate a training intervention for recruiting patients to randomized controlled trials (RCTs), particularly for those anticipated to be difficult for recruitment. STUDY DESIGN AND SETTING: One of three training workshops were offered to surgeons and one to research nurses. Self-confidence in recruitment was measured through questionnaires before and up to three months after training; perceived impact of training on practice was assessed after...
November 27, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29179624/invited-commentary-on-dub%C3%A3-et-al-perceptions-of-equipoise-risk-benefit-ratios-and-otherwise-healthy-volunteers-in-the-context-of-early-phase-hiv-cure-research-in-the-united-states-a-qualitative-inquiry-are-hiv-infected-candidates-for-participation-in-risky
#17
https://www.readbyqxmd.com/read/29175968/learning-health-systems-clinical-equipoise-and-the-ethics-of-response-adaptive-randomisation
#18
Alex John London
To give substance to the rhetoric of 'learning health systems', a variety of novel trial designs are being explored to more seamlessly integrate research with medical practice, reduce study duration and reduce the number of participants allocated to ineffective interventions. Many of these designs rely on response adaptive randomisation (RAR). However, critics charge that RAR is unethical on the grounds that it violates the principle of equipoise. In this paper, I reconstruct critiques of RAR as holding that it is inconsistent with five important ethical principles...
November 24, 2017: Journal of Medical Ethics
https://www.readbyqxmd.com/read/29175233/biological-information-systems-evolution-as-cognition-based-information-management
#19
REVIEW
William B Miller
An alternative biological synthesis is presented that conceptualizes evolutionary biology as an epiphenomenon of integrated self-referential information management. Since all biological information has inherent ambiguity, the systematic assessment of information is required by living organisms to maintain self-identity and homeostatic equipoise in confrontation with environmental challenges. Through their self-referential attachment to information space, cells are the cornerstone of biological action. That individualized assessment of information space permits self-referential, self-organizing niche construction...
November 22, 2017: Progress in Biophysics and Molecular Biology
https://www.readbyqxmd.com/read/29171051/the-real-world-ethics-of-adaptive-design-clinical-trials
#20
Laura E Bothwell, Aaron S Kesselheim
From the earliest application of modern randomized controlled trials in medical research, scientists and observers have deliberated the ethics of randomly allocating study participants to trial control arms. Adaptive RCT designs have been promoted as ethically advantageous over conventional RCTs because they reduce the allocation of subjects to what appear to be inferior treatments. Critical assessment of this claim is important, as adaptive designs are changing medical research, with the potential to significantly shift how clinical trials are conducted...
November 2017: Hastings Center Report
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