Kenneth M. Kessler, MD
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Kessler KM. The CONSORT Statement: Explanation and Elaboration. Ann Intern Med. 2002;136:926. doi: 10.7326/0003-4819-136-12-200206180-00015
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Published: Ann Intern Med. 2002;136(12):926.
TO THE EDITOR:
Despite the rigor of the CONSORT statement (1, 2), in reality the results of most clinical trials are reduced to a single number: some expression of the treatment effect. The CONSORT statement primarily recommends the reporting of treatment effect as a representation of relative risk. However, relative risk may seriously overestimate treatment effect whenever the outcome prevalence is significantly less than 100% (3, 4). The CONSORT statement secondarily recommends using the number needed to treat (NNT), a value that reflects outcome prevalence as well as treatment effect. The NNT seems to have become popular because it is a whole number and larger than the absolute risk reduction, the number from which it is derived. However, the NNT may be difficult to interpret (3). For example, NNT is an inverse function and increases with decreasing treatment effect. Moreover, the CONSORT statement primarily recommends reporting adverse events in absolute numbers, which would leave the reader the difficult task of comparing an absolute rate of adverse events with treatment effect expressed as the relative risk or the NNT. Even when adverse events are reported as the number needed to harm (NNH), direct comparison of an NNT (for example, 20) with an NNH (for example, 100) generally requires converting these values to the decimals from which they are derived. Wouldn't it be simpler and more accurate to report treatment effect as the absolute risk reduction? Shouldn't this be done per unit of time rather than over the nonstandard period of a specific clinical trial, with appropriate caveats when the treatment effect is not linear over time?
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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