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Published byMark Shaw Modified over 9 years ago
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Weaknesses of major randomized trials: they are cleverly designed against coronary surgery. They are not representative of the daily practice (highly selected patient population), but their results are generalized for the whole population with CAD.
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RANDOMIZATION IN ARTS TRIAL (Arterial Revascularization Therapy Study) University Hospital Zürich, April- December 1997 5/986 (0.5 %) patients
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STUDY ENROLLMENT IN MAJOR RANDOMIZED STUDIES COMPARING PTCA TO CABG (91 730 patients) RITA, ERACI, GABI, EAST, CABRI AND BARI trials
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It is a well-known fact that patients recruited for trial have better survival and better results than those eliminated from the trial because of some exclusion criteria.
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NIFEDIPINE IN ACUTE MYOCARDIAL INFARCTION (TRENT TRIAL) (9292 patients admitted with AMI)
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When analyzing a trial, look carefully at “Material and Methods” section: crucial information explaining the results might be found there.
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Serruys P et al. N Engl J Med 2009;360:961-972 Enrollment and Randomization of Patients with Previously Untreated Three-Vessel or Left Main Coronary Artery Disease in the SYNTAX Trial 2 years, 85 centres:10.6 patients/year
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Average number of patients seen by centres in Syntax trial is less than 11 patients/year! If we accept the fact that “all comers” entered the trial, these centres should have been closed long ago, according to present standard of PCI and CABG practice.
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Serruys P et al. N Engl J Med 2009;360:961-972 Cardiac-Related Medications Given after the Study Procedure
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A study with a radically different drug treatment protocols in the two analyzed groups is statistically invalid.
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Difference in outcome in trials funded by for-profit and not-for-profit sources JAMA 2006; 295(19):2270-4
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Beware of industry sponsored trials! Results very often meet the sponsor’s expectations!
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CABG MORTALITY RATES AMONG DIFFERENT SURGEONS: A PROSPECTIVE STUDY JAMA 1991;266:803-809
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There is a major difference between swallowing a pill and performing a complex operation; this fact is not appreciated by statisticians.
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Survival with CABG @ 3 years is 28.4 % higher! Hannan E et al. N Engl J Med 2005;352:2174-2183
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Non-randomized observational trials can reach very important results, which are presently ignored by the academia schooled in conventional statistics
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