11:51 Jul 29, 2007 |
English language (monolingual) [PRO] Medical - Medical: Cardiology | |||||
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| Selected response from: Dr Sue Levy (X) Local time: 09:07 | ||||
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SUMMARY OF ALL EXPLANATIONS PROVIDED | ||||
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5 +1 | composite endpoint |
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3 +1 | sum |
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3 +1 | possible interpretation |
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Discussion entries: 4 | |
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sum Explanation: I suppose that in terms of this protocol the importance of all the listed events is equal. The primary endpoint will be the sum of incidence rates of A, B and C. A-occluded infarct-related artery on the predischarge angiogram, B-death C-recurrent MI before coronary angiography |
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possible interpretation Explanation: The endpoint was primarily determined by an occluded infarct-related artery on the predischarge angiogram, death, or recurrent MI before coronary angiography. IMO these conditions are independent, so 'composite' or 'combination' is inappropriate. What the author probably had in mind is that these events formed the 'primary group' of endpoints (or endpoint-determining events). |
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composite endpoint Explanation: The text is poorly worded. What it means is that the study uses a composite endpoint - in other words, several single endpoints are valid - in this case either of the three stated endpoints, but obviously a combination is not required (or even possible!). http://www.actmagazine.com/appliedclinicaltrials/article/art... A composite endpoint in a RCT consists of multiple single endpoints that are combined in order to confront an investigational drug with a higher number of events expected during the trial. For instance, the primary composite endpoint may include mortality along with nonfatal endpoints such as hospitalization and cardiac arrest in chronic heart failure patients,6 or along with myocardial infarction and stroke in hypertensives.7 The major advantages in using a composite endpoint are: statistical precision and efficiency will be increased8 ; trials become smaller, less costly; and the results of promising new treatments will be available earlier. If more than one outcome is important for efficacy evaluation, a composite endpoint can efficiently deal with the issue of multiplicity.9 A summary measure for drug efficacy can be defined10 (e.g., the assessment of skeletal-related events [SREs] in trials for prevention or treatment of bone metastases). |
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Grading comment
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