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Note: Since your browser does not support Javascript, you must press the Continue button once to proceed. Our New BMJ website does not support IE6 please upgrade your browser to the latest version or use alternative browsers suggested below. MIAMI BEACH, FLA.—Patients with femoropopliteal lesions who receive 12 months of cilostazol after endovascular stenting experience restenosis rates 50% lower than those in patients who do not receive the drug. Hiroyoshi Yokoi, MD, of Kansai Rosai Hospital Cardiovascular Center, presented findings at TCT 2012 from the STOP-IC trial, which examined whether cilostazol can reduce binary restenosis after endovascular therapy in patients with symptomatic leg ischemia.
The primary endpoint of angiographic restenosis at 12 months verified by an independent core lab was significantly lower in the cilostazol group, whether ascessed by per-protocol or intention-to-treat analysis (see Figure). The secondary endpoint of 12-month per-protocol restenosis assessed by angiography or duplex was 19% of 93 patients in the cilostazol group and 41% of 97 patients in the non-cilostazol group (P=.001). At 1 year, cilostazol patients showed a lower rate of TLR, while other clinical outcomes including bypass conversion, stent fracture, amputation and mortality were equivalent (see Table). Eligibility criteria included Rutherford classification 2-4 with de novo femoropopliteal lesions presenting >50% stenosis by angiographic follow-up.
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A recent CA ITT analysis determined that faecal occult blood testing reduces mortality from colorectal cancer by 25% if the patient returns the sample cards, rather than by 19%, the value associated with being randomised to receive the test kit.32Adjusting randomised trials for treatment contamination could allow more nuanced understanding of the medical literature. Subanalysis showed that cilostazol was effective in the prevention of restenosis across multiple subgroups. He added that late clinical failure, especially angiographic restenosis, is an important concern with high restenosis rate, and while cilostazol therapy after endovascular stenting for femoropopliteal lesions may improve outcomes, it has been unclear whether the drug can reduce angiographic restenosis after such therapy.
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The Tengiz oil field was discovered in 1979 and is one of the deepest and largest oil fields in the world. The methods used historically to deal with this problem, the “as treated” and “per protocol” analysis techniques, are flawed and inaccurate. For example, the 1994 Scandinavian Simvastatin Survival Study (4S)33 found a 20% greater effect of simvastatin on cardiac events than did the 2002 Heart Protection Study (HPS).34 Although other explanations are possible, differences in treatment contamination clearly played a role. Both groups were taken off ticlopidine at the 1-month mark, and either aspirin alone or aspirin and cilostazol was continued up to 12 months. Other baseline data indicated statin treatment in about 35% of patients, diabetes in 56% and end-stage renal disease in 16%. If Turkey would stop its bombardments and raids against the PKK in Turkish cities and return to peace talks, we could have a cease-fire on the same day. Consequently, much of the country is without power and there is insufficient fuel to power the pumps.
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Its oil reserves are estimated at between 750 million and 1.1 billion tons (6-9 billion barrels) of recoverable oil. Intention to treat analysis is the solution most often used to analyse randomised controlled trials, but this approach ignores this issue of treatment contamination. The Heart Protection Study, which unlike the Scandinavian Simvastatin Survival Study occurred after statins were in general use, had much higher treatment contamination. These are complemented by all of the external accommodation suppliers who have to collect the students’ rent, maintain their buildings and receive their own supplies to do the same. And we are definitely the only platform company in the world that has a vested interest in making its ecosystem cross-platform. Knowing this is my last time racing here at the Ridges, it's kind of sad, but I think it was a great way to end my high school Wisconsin cross country career. The Ortegas now own their own farm, Natalie’s Garden and Greenhouse, just outside of Oregon, and grow many vegetables Ortega grew as a kid, such as carrots, zucchini, tomatillos, peppers and sweet corn. Les dirigeants travaillistes Itzhak Herzog, Tzipi Livni et Shelly Yachimovich poussent de hauts cris, rejoints par une foule de lib raux autoproclam s de la droite, dont le pr sident Rivlin et l ancien ministre de l Int rieur Guideon Saar.
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In that context this literature review produced by the Governance and Social Development Resource Centre (GSDRC) is a useful stock take, citing both humanitarian policy documents as well as real-life examples of LRRD being applied. Unlike the minister, whose every word could affect billions of dollars on the commodity markets, Muhanna can speak more freely. And even though everyone has been bundled up like Nanook of the North lately, no one pointed out the coatroom.
When deciding tosupport UN Security Council Resolution 1970 andmaking no objection toResolution 1973 onLibya, we believed that these decisions would help limit theexcessive use offorce andpave theway fora political settlement. Intention to treat analysis estimates the effect of recommending a treatment to study participants, not the effect of the treatment on those study participants who actually received it. This difference alone would account for almost all of the difference between the intention to treat estimates reported in these two trials.What are the benefits and limitations of CA ITT estimates?The primary benefit of CA ITT analysis is improved accuracy in estimating the size of treatment benefit for a patient who receives the treatment.
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Unfortunately, theactions undertaken byNATO countries under these resolutions led totheir grave violation andsupport forone ofthe parties tothe civil war, with thegoal ofousting theexisting regime, damaging inthe process theauthority ofthe Security Council.
I love this drop lamp hung in threes over a dining-room table or on its own in a cozy reading-nook corner. He understands his responsibility, and he understands what we re trying to do as a football team. In this article, we describe a simple yet rarely used analytical technique, the “contamination adjusted intention to treat analysis,” which complements the intention to treat approach by producing a better estimate of the benefits and harms of receiving a treatment.
Prior to the beginning of each session, the agents were informed that providing false testimony to the body was unlawful. And a few of Ortega’s twelve brothers and sisters live in the area and help out on the farm. Wholesale Jerseys "This report is relevant to persons who are seriously ill, their parents, children, extended families which essentially means every American," said VJ Periyakoil, director of Palliative Care Education and Training at Stanford University's School of Medicine, who was not involved in the report.
He assigns her to the island to research immortality, and she suspects the key to realizing it lies in the pre-teen Natalia, another prisoner. Shapcott describes Golf Revolution as the “yoga model”—you join a club and drop in for as much or as little training as you want in a pay-as-you-go way. This method uses the statistical technique of instrumental variable analysis to address contamination. The exact effect size of a treatment is relevant whenever you weigh a treatment against negative consequences like side effects, against treatment costs in cost effectiveness analyses, or against another treatment.
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It's also Natalia who greets Barry when he arrives on the island six months after Claire and Moira's escape attempt, searching for them. The name riffs on Matson's love of traditional folk textiles and patterns that inspire and become incorporated in her work. We discuss the strengths and limitations of the current methods of addressing treatment contamination and the contamination adjusted intention to treat technique, provide examples of effective uses, and discuss how using estimates generated by contamination adjusted intention to treat analysis can improve clinical decision making and patient care.IntroductionThe recent European Randomized Study of Screening for Prostate Cancer1 concluded that 1400 patients would need prostate specific antigen screening in order to prevent one death from prostate cancer. For example, if many patients stop taking a weight loss drug because of side effects, an intention to treat analysis would measure early treatment side effects appropriately but assess long term weight loss and side effects quite poorly. The insurgents want to carve out a separate state governed by their strict interpretation of Islamic law, and some have links to the Islamic State group.
This number will be used in meta-analyses, cost effectiveness analyses, and clinical guidelines. The comparative effectiveness of two chemotherapeutic regimens with different contamination rates could similarly be misleading to patients and clinicians.8 32 In addition, the estimate of benefit in many cost effectiveness analyses is based on the outcome of an intention to treat analysis, but the estimated treatment cost assumes 100% adherence. In the study, nearly 20% of people assigned to receive prostate specific antigen screening didn’t undergo a single test in 10 years. This disparity will result in underestimation of the treatment’s cost effectiveness and will particularly disadvantage effective but costly treatments.CA ITT analysis of randomised controlled trials has some limitations. In a similar American randomised controlled trial,2 40% of participants who weren’t supposed to receive prostate specific antigen screening were actually tested. Treatment contamination is not always assessed in clinical trials and can be quite difficult to measure, especially in trials of medications for chronic conditions. Both these trials were analysed and interpreted as though all participants followed the treatment they were randomised to. If participants had in fact adhered to their assigned intervention as randomised, would the results have been different? Most importantly, the CA ITT technique assumes that if non-adherents had received the treatment, the treatment would have had the same medical effect as it did in adherents. Are the results accurate when it comes to advising individual patients whether they should be screened?Randomised controlled trials are the “gold standard” for examining the efficacy and safety of medical interventions because they are considered free from bias. If non-adherent or crossover patients exhibit a different treatment benefit from adherents, a CA ITT analysis will be biased.
However, what was seen in the recent prostate specific antigen trials is common in randomised controlled trials and makes the published data less reliable. When study participants do not receive the treatment to which they were randomised, the flaw called “treatment contamination” is created. However, trials do not often proceed like this and are unlikely to do so more often in the future, so an intention to treat analysis will rarely provide an accurate estimate of treatment benefits for those receiving a treatment.
Treatment contamination can occur through treatment non-adherence (not receiving the recommended intervention because of treatment intolerance or patient preference) and treatment crossover (receiving the intervention intended for the other group in a trial). In major trials, efforts should be taken to limit and quantify treatment contamination with close follow-up of study participants, surveys to assess and optimise adherence, and use of intermediate measures of adherence and effectiveness (such as following change in low density lipoprotein in cholesterol trials that are powered for survival). Just as non-adherence is common in clinical practice, treatment contamination in randomised controlled trials is not a small or infrequent problem—some of our largest trials have contamination of more than 30%.3 4 5 6In this paper, we describe a method called the “contamination adjusted intention to treat” (CA ITT) analysis that better estimates the benefits of receiving a treatment.
However, contamination is not always just a nuisance factor—it can demonstrate important factors such as how well patients tolerate treatment side effects. CA ITT analysis uses an established statistical technique called instrumental variables (IVs) analysis to adjust for the bias created by contamination. Once deviations from random assignments occur, regardless of the reason, scientists running trials should examine how treatment contamination has affected their results. The most commonly used approaches historically are the “as treated” and “per protocol” techniques, which have appropriately fallen out of favour (table?). In as treated analyses, participants are analysed entirely on the basis of treatment received (that is, according to their behaviour, not their random assignment). In per protocol analyses, participants who fail to follow the protocol are simply dropped from the study (that is, included or excluded according to their behaviour).
Intention to treat analysis avoids the flaws of the as treated and per protocol approaches and should always be the initial analysis of a randomised controlled trial. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Throughout the 1970s and 1980s, American states had many and varied increases in tobacco taxes that clearly altered smoking rates across states. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Increases in cigarette taxes seem unlikely to affect birth outcomes other than through the effect on smoking.
Researchers used a statistical technique known as IV analysis to estimate the impact of smoking on birth outcomes by comparing birth outcomes and changes in smoking rates with state changes in cigarette taxes.16IV techniques were designed to learn from natural experiments (that is, changes in people’s environments or exposures unrelated to their individual choices or behaviours), in which an unbiased “instrument” (such as change in tobacco taxation level) makes the exposure of interest (such as an individual’s smoking habits) more or less likely but has no other effect, either directly or indirectly, on the outcome. IV analysis assesses how the instrument predicts the exposure and the outcome, then uses that information to understand how the exposure predicts the outcome.
The most common IV in medicine is randomisation within a randomised controlled trial that has treatment contamination. IV analysis can bridge the gap between the more policy focused question posed by intention to treat analyses and the patient focused question of biological efficacy.8 23 24 The concept behind a CA ITT analysis is quite simple. The randomised controlled trial is treated as an IV, with treatment assignment as the “instrument.” The effect of treatment assignment on outcome observed (intention to treat analysis) is adjusted by the percentage of assigned participants who ultimately receive the treatment (contamination adjustment). This way the effect of treatment receipt on the risk of the outcome can be obtained (fig?). If a patient stops taking a medication early, the measured non-adherence can be adjusted for with CA ITT and the biases of as treated and per protocol analyses can be avoided. Estimating treatment effects from randomized clinical trials with noncompliance and loss to follow-up: the role of instrumental variable methods. In per protocol and as treated analyses (A), random assignment is ignored, creating less reliable results. In intention to treat analyses (B), only the effect of randomisation is assessed, not the effect of receiving the intervention.



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