Ctj.sagepub.com: 7/9/12.. Clinical equipoise is widely regarded as an ethical requirement for the design and conduct of randomized controlled trials (RCTs). Underlying clinical equipoise is the norm that no patient should be randomized to treatment known (or believed by the expert clinical community) to be inferior to the established standard of care. This implies that patient-subjects should not be exposed to net risks in control groups of randomized trials - risks that are not compensated by the prospect of direct medical benefits from the control intervention. However, proponents of clinical equipoise have no moral objections to permitting net risks for nontherapeutic research procedures employed in clinical trials. This differential assessment makes risk-benefit assessment of randomized trials incoherent. In this article, I examine critically four arguments in defense of clinical equipoise as a requirement for risk-benefit assessment. Read more. ...

Abstract Equipoise, or the criterion of honest professional uncertainty in the clinical community, is currently the most widely accepted standard for adjudicating the ethical dilemmas of medical research involving human patients. Nonetheless, equipoise has recently become a subject of considerable criticism. Among the objections to equipoise, an important one is based on the observation of an objective difficulty for equipoise in providing sound ethical guidance in practical circumstances that arise in clinical research. A chief example of such problem is represented by the case of monitoring accumulating data from a trial. In this article we argue that the perceived inadequacy of equipoise in this context is caused by a widespread misconception of the relation between equipoise and more fundamental ethical principles. We argue that, when interpreted as a mid-level principle (Rachels, 2009), the value of equipoise as the appropriate ethical guidance for clinical research becomes more firmly ...

The importance of unbiased comparative research trials to answer clinical questions that guide best treatment practices is unquestionable. Large multicenter clinical trials are critical for answering important clinical questions that cannot be answered by observational data. These studies depend on adequate recruitment from unbiased samples of patients from the population of interest. Investigators participating in such trials must also have clinical equipoise that the treatment under study may or may not be better than the standard treatments available. If such clinical equipoise does not exist, then recruitment will be biased and potentially delayed. In recent years, stroke clinical trials have struggled to enroll patients to acute trials for a variety of reasons, including narrow eligibility time windows and, most recently, to the growing list of available, although not necessarily safe or efficacious, therapies.. In January 2008, the US Food and Drug Administration cleared the second device ...

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For many years equipoise has been compared by internet gurus to other steroids like deca durabolin and dianabol. However, they likely have never tried any of them to make such an observation. In spite of the fact that it works like those anabolic steroids, it is nothing like them, and calling these compounds the same is like comparing apples to oranges.. First off, equipoise does not aromatize like dianabol nor does it work as fast. Hence, if you are looking to put on 10 pounds of water in a couple weeks, then EQ will not help you. Next, it has no progestin properties at all, so it is different compared to deca durabolin in that way too. Though, you could argue that they have similar mild and slow acting properties.. Nevertheless, things are much simpler when it comes to comparisons. All you need to do is look at the stats on paper, and you will see that the closest thing to EQ is straight testosterone. The only exception is an added double bond at the carbon 1 and 2 positions, which is why ...

The Authors reply: In response to our paper,1 R K Mohindra argues that the underlying empirical evidence base is in equipoise with regard to antibiotic prophylaxis for infective endocarditis and that this means that NICE should not have intervened with its new guidelines.2 This equipoise … ...

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Equipoise is not a rapid mass builder, but will provide a slow but steady gain of strength and quality muscle mass. The most positive effects of this drug are seen when it is used for longer cycles, usually lasting at least 10 weeks in length. The muscle gained should not be the smooth bulk seen with androgens, but instead a very defined and solid look ...

Ebrahim Barkoudah, MD, MPH, FACP 1 3, Larry A Weinrauch, MD 2 3 1 Department of Medicine Brigham and Womens Hospital; 2 E P Joslin Research Laboratory, Department of Global Health and Population; and 3 Harvard Medical School, Boston, all in MA November 20, 2015 The Benefits of Screening and Treating Abnormal Blood Glucose in the Population TO THE EDITOR: We read with interest the US Preventive Services Task Force recommendations for screening of asymptomatic adults, in primary care settings. While the focus on hard events in clinical trials is understandable and appropriate, discounting morbid events in the production of guidelines is not fully examined. Focusing on all-cause mortality in patients at low risk of events and for short observation time is insufficient to draw conclusions, when mortality rates are low.1 Therefore, a finding of clinical equipoise may represent a statistical error, as the studies are underpowered to define a difference between strategies. Trials may demonstrate ...

After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility ...

Clinical equipoise exists around the optimal time to start adjuvant endocrine therapy in patients who will receive post-operative radiotherapy for breast cancer. Patients receive either concurrent or sequential endocrine and radiation therapy, where concurrent therapy consists of endocrine therapy started before, with or during radiotherapy, while sequential treatment is defined as endocrine therapy starting after the completion of radiotherapy. A recent survey of Canadian oncologists showed that the main reason for prescribing sequential endocrine therapy was a concern that concurrent endocrine therapy and radiotherapy would worsen the toxicity of endocrine treatment. This is despite the absence of any clinical trial evidence to support this. Indeed, a recent systematic review by our group was unable to confirm or refute whether increased toxicities, related to the timing of endocrine therapy and radiotherapy actually exist in clinical practice. The investigators are therefore proposing a ...

I did a lot of Testosterone. I did about 3000 mg of Test per week. I love Testosterone and I love Equipoise. The Test I did was mostly propionate. Once in a while I would do enanthate and I would always keep it with Equipoise. Id probably do, oh God… I would do a shot every other day. I wouldnt worry about the amount of oil; I would worry about the amount of drug. Over the course of a week, I take 3,000 mg of Test and probably put in 400 to 500 mg of Equipoise. Remember, thats 15 mg shots. So that would be about 10 CCs of EQ over a weeks period. I would do shoulders, triceps, and biceps. ...

Bland M. Uncertainty is in the blood. Equipoise 2014; 6-7. Equipoise is the journal of the Department of Health Sciences, University of York. The Spring 2014 issue, The Uncertainty Issue includes Uncertainty is in the blood. Warning: this is a really big file and you may have give it time to download before trying to scroll through. I hope you like it. The rest of the journal is good, too. ...

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Equipoise and Winstrol have long been praised by strength and endurance minded athletes. Depending on an individuals tolerance and specific needs, dosage can vary. The prevailing wisdom states that Equipoise and testosterone ethanate should be taken in 500 mg doses for fourteen weeks, adding Winstrol to the stack for an additional six weeks.. Steroid stacks work best when the stack is targeted to a specific outcome. It is important that proper post-cycle therapy is carried out in all cases. This therapy eliminates the risk of permanent side effects. With a little common sense, improving athletic performance, cutting or bulking with a steroid stack be a safe and effective part of fitness training. ...

36 years old 6 foot 1 in tall 197 pounds my body fat is under 11% I have been Lifting for half my life last cycle was testosterone only, this time I want to add some EQ equipoise. My goal is to increase my cardio, have more intense workouts, and also cut down a little bit further. Do you think equipoise would be good for me and how much would you use

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My point here is not to speak badly of the need for safety in hospitals, rather a need to gain some equipoise on the subject. It is true that weve done a pretty good job improving surgical infection rates in America with things like pre-procedure antibiotics, antibacterial drapes, and good technique. But I wonder whats more expensive for our system in the long run, hand washing with soap and water or foam alcohol dispensers that have cannisters that have to be refilled and repurchased time and time again. what about all those plastic gowns we wear because a nasal swab shows traces of the genetic makeup of a single methicillin-resistant bacillus in a patients nose? Or might all that plastic we purchase ultimately become more expensive to our health care system and environment in the long run ...

I have been training in the gym my whole adult life. Decided to do a cycle of T propionate 300 mg/week, and the gains were spectacular. The following two cycles did nothing to mass or strength, even though I upped the doses, and added equipoise and dbol, so I stopped doing cycles altogether. That was four years ago. Now diagnosed with low T, went on TRT two months ago, T enanthate 200 mg/week. No benefit to training what so ever. I eat plenty of food, sleep well, no alcohol or drugs, I take

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Biostatisticians have frequently uncritically accepted the measurements provided by their medical colleagues engaged in clinical research. Such measures often involve considerable loss of information. Particularly, unfortunate is the widespread use of the so-called responder analysis, which may in …

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The histogram is divided into 20 bins, and the frequency of p-values in each bin are plotted. This means all significant results (p , 0.05) fall in the left-most bin. If all non-significant studies examined no true effects, the p-values would be uniformly distributed, with 3.4 studies in each bin (64 non-significant studies (there are 99 p-values plotted, so 99-35=64) in 19 remaining bins). If we think of this p-value distribution as a mix of null effects (uniformly distributed) and true effects (a skewed distribution highest at low p-values), the distribution is not a shallow curve (which would be a sign of low power, see p-value distributions as a function of power here). Instead, the distribution looks more like a sharp angle, which mirrors a p-value distribution from a set of highly powered experiments. It really looks like our power was very high (but we should remember we only have 100 datapoints). There will certainly be some replication studies that, with a much larger sample size, will ...

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The difference between using a modified ordinal system such as you suggest and using a grading or rating system is the following. Using ordinals while permitting ties and gaps suggests the following: Assuming that the top four judges are tied, you could give them all 1s, all 4s, all 2.5s (or perhaps any number between 1 and 4). But the issue is what the next judge ranking is. If you say that its a 5, youre still in the realm of an ordinal solution. But if you let 1-4 be 1s and then let 5 be a 3 and never have any rule that they need to correlate, youve moved into a rating system that really isnt ordinal at all (in the statisticians sense of that word). But your point might be that we need to have as many possible grades as we have judges so that someone could be fully ordinal if they wanted to be. There are a couple of reasons I wouldnt go this direction. First we can permit teams to avoid all ties by not requiring whole number values for the grades. Unlike speaker points where ...

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The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research.

The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT ...

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Introduction. Carotid artery stenting (CAS) has achieved clinical equipoise with carotid endarterectomy (CEA), as demonstrated by multiple large randomized clinical trials (RCTs), multiple pivotal registry trials resulting in Food and Drug Administration (FDA) clearance of 7 carotid stent systems, and 2 multispecialty guideline documents endorsed by 14 professional societies that endorse CAS as an option to CEA for stroke prevention.1. Approximately 20 years ago, several RCTs compared medical therapy with CEA for both symptomatic and asymptomatic patients. CEA was superior to medical therapy (primarily aspirin) for stroke prevention. As less-invasive revascularization techniques with stents evolved and became more successful, pivotal trials were performed to obtain FDA approval, and head-to-head comparisons with CEA were performed.. Clinical Trials. CAS is the preferred treatment for patients at increased risk for CEA (high-surgical-risk patients). The SAPPHIRE (Stenting and Angioplasty With ...

PURPOSE: Evidence regarding whether or not antibiotic prophylaxis is beneficial in preventing post-operative surgical site infection in adult inguinal hernia repair is conflicting. A recent Cochrane review based on 17 randomised trials did not reach a conclusion on this subject. This study aimed to describe the current practice and determine whether clinical equipoise is prevalent. METHODS: Surgeons in training were recruited to administer the Survey of Hernia Antibiotic Prophylaxis usE survey to consultant-level general surgeons in London and the south-east of England on their practices and beliefs regarding antibiotic prophylaxis in adult elective inguinal hernia repair ...

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Increasing the high number of under-fives entering the age of study, commonly called early childhood education (Pendidikan Anak Usia Dini-PAUD), creates an opportunity to design a product that supports learning activities for the toddlers, namely folding study desks. This research aims to make a redesign of folding table-chair products specially designed for toddlers by considering ergonomic aspects that prioritize function and comfort using Quality Function Deployment (QFD) method through anthropometry approach of toddlers body. This study focuses on toddlers aged 3 yr to 5 yr who are students of the playing group and kindergarten at Integrated Islamic Kindergarten (Taman Kanak-kanak Islam Terpadu-TKIT) Rabbani. Different body sizes of toddlers with adults are the main consideration in determining anthropometric approach, but it is also expected to produce ergonomic products both in terms of materials and product size to a childs sitting position. The results of this study obtained a ...

JAMA recently stated that it would no longer accept industry-sponsored trials in which the data analysis was performed solely by the sponsors statisticians, instead requiring that the analysis be performed by or independently validated by an academic statistician. Although this policy has created some concern in the statistical community, the reaction has been modest. I suggest that this policy has important implications for the role of the statistician in biomedical research and deserves more attention that it has received so far.

Outline of Randomization Lectures 1. Background and definitions 2. Generation of schedules 3. Implementation (to ensure allocation concealment, sometimes called blinded randomization) 4. Theory behind randomization Readings • Chapter 6 of Friedman, Furberg and DeMets • Supplemental notes for week 3 on the class web site • Other papers are cited in the notes Key Points • A random process should be used to generate treatment allocations or assignments • Treatment allocations should be concealed until the time of randomization - allocation concealment is critical to prevent selection bias. Some refer to this as blinded randomization. (It should not be confused with blinding of treatments). Randomization Assignment of experimental units to treatment by a random process such that neither investigator nor patient knows the treatment to be assigned at the time the patient is registered. Timing of Randomized Trials Considerations • 1st patient (Chalmers) • Strong degree of equipoise ...

The QRI research team will present summaries of anonymised findings to the RCT CI and TMG (as agreed a priori), identifying the factors that appear to be hindering recruitment and including anonymised supporting evidence. The QRI team will suggest a potential plan of action to improve recruitment, based on the findings from the specific RCT but also including experience from other QRIs for generic issues. The CI/TMG will then need to decide on the content of their plan of action to improve recruitment.. The aspects that the QRI team will be able to work with the RCT team on are likely to include providing feedback and training on generic recruitment issues, such as how to present the RCTs design and interventions more clearly to improve levels of understanding and informed consent, how to approach patients treatment preferences, and, perhaps, facilitating discussions around issues of eligibility assessment, equipoise, and team-working, or potential changes to the protocol - as ...

After the results of the WAKE-UP trial were published in May 2018, the DSMB recommended discontinuation of the trial due to a loss of equipoise. Over a period of 8 years, 225 patients were enrolled (113 alteplase and 112 placebo). The mean age in the alteplase group was 73.7 years (vs 71.0 years in the placebo group), and median NIHSS in the alteplase group was 12 (IQR 8-17) and 10 (IQR 6-16.5) in the placebo group. Of the entire cohort, 10% were randomized in the 4.5-6 hour window, 25% in the 6-9 hour window and 65% that awoke with symptoms. The median time from stroke onset to study intervention was 432 minutes (IQR 374-488) in the alteplase arm and 450 minutes (IQR 374-500) in the placebo arm. The alteplase arm had 69% with a large vessel occlusion (vs. 72.3% in the placebo arm). The median core infarct volumes were 4.6 ml (IQR 0-23.2) and 2.4 ml (IQR 0-19.5) ml in the alteplase and placebo arm respectively. The median volumes of the ischemic areas (core+penumbra) were 74.3 ml (IQR 40.1-134) ...

A number of reasons may account for the striking discordance between experimental studies, which almost overwhelmingly have been supportive of a beneficial effect, and large randomized controlled trials assessing hard outcomes such as ALTITUDE. The most obvious of these are differences between experimental animal models and humans, design considerations, lack of experimental equipoise, biological noise, and publication bias, all of which may fail to alert one to possible adverse signals.26 The short-term nature of almost all of the humans studies using surrogates versus those using hard outcomes, differential responsivity of some end points to RAAS blockade, and the inclusion of patients with advanced CKD represent important additional consideration.27 In support of CKD status being an important driver of adverse events, studies that have examined the combination of ARB+Aliskiren with milder degrees of CKD have not demonstrated adverse events, despite reductions in ambulatory BP in the ...

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Is science broken? A lot of people seem to think so, including some esteemed statisticians. One line of reasoning uses the concepts of false discovery rate and its complement, positive predictive value, to argue that most (or, at least, many) published scientific results must be wrong unless most hypotheses are a priori true.. The false discovery rate (FDR) is the probability that a significant p-value indicates a false positive, or equivalently, the proportion of significant p-values that correspond to results without a real effect. The complement, positive predictive value (\(PPV=1-FDR\)) is the probability that a significant p-value indicates a true positive, or equivalently, the proportion of significant p-values that correspond to results with real effects.. I became interested in this topic after reading Felix Schönbrodts blog post, Whats the probability that a significant p-value indicates a true effect? and playing with his ShinyApp. Schönbrodts post led me to David Colquhouns ...

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A statistical analysis of the factors that determine how long Olympic records last reveals how many are likely to fall in the next two weeks in London

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This map is a cartogram where the original shapes of each territory mapped is proportional to the variable mapped. Values for more than 200 territories are used to create the map. That number of figures is far too big to be able to take in at a glance. However the brains visual processing skills are phenomenal, and presented as a picture you have no difficulty with that number. Before you look at a particular map, you usually have some ideas about the subject. Some of those ideas may be confirmed, other things may surprise you. You, not the cartographer, not the statistician, decide what is most striking about the figures. ...

k stands for 1000 (as in kb=1000 bytes, for instance). What are your Level 1 observations (i.e., the 6192)? If only 72 bears were exported from the US in a given year then figures in the ballpark of hundreds of thousands appear fairly high to me? J. On Thu, Jun 23, 2011 at 2:14 PM, Lukas Bösch ,[email protected], wrote: , In my opinion the scales dont differ wildly. , I am not a statistician though, so maybe you have a different opinion. , , , . sum centgdp2 , , Variable , Obs Mean Std. Dev. Min Max , -------------+-------------------------------------------------------- , centgdp2 , 6192 -.0835699 .8318088 -.3333735 5.257175 , , . sum centlandarea2 , , Variable , Obs Mean Std. Dev. Min Max , -------------+-------------------------------------------------------- , centlandar~2 , 6192 -.0336882 .9528875 -.6987395 2.490177 , , . sum centpopulation2 , , Variable , Obs Mean Std. Dev. Min Max , -------------+-------------------------------------------------------- , centpopul~n2 , 6192 -.0018452 ...

Highland Statistics Ltd. provides 10 different 5-day statistics courses. The course instructors are Dr. Alain Zuur (statistician) and Dr. Elena Ieno (biologist). Our statistical and biological backgrounds ensure a lively and enjoyable interaction with our participants. One of our strong points is explaining statistics in a non-technical and understandable language.. We teach around 25 statistics courses per year all over the world. These are our courses:. ...

The UKs national statistician said he has "no doubt" that there will be a further wave of Covid-19 infections in the autumn.