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Open Access Research article

Calculation of NNTs in RCTs with time-to-event outcomes: A literature review

Mandy Hildebrandt12*, Elke Vervölgyi1 and Ralf Bender13

Author Affiliations

1 Institute for Quality and Efficiency in Health Care (IQWiG), Dillenburger Str. 27, 51105 Cologne, Germany

2 Institute for Medical Biometry, Epidemiology and Informatics (IMBEI), Johannes-Gutenberg-University Mainz, 55101 Mainz, Germany

3 Medical Faculty, University of Cologne, Joseph-Stelzmann-Str. 9, 50931 Cologne, Germany

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BMC Medical Research Methodology 2009, 9:21  doi:10.1186/1471-2288-9-21

Published: 20 March 2009

Abstract

Background

The number needed to treat (NNT) is a well-known effect measure for reporting the results of clinical trials. In the case of time-to-event outcomes, the calculation of NNTs is more difficult than in the case of binary data. The frequency of using NNTs to report results of randomised controlled trials (RCT) investigating time-to-event outcomes and the adequacy of the applied calculation methods are unknown.

Methods

We searched in PubMed for RCTs with parallel group design and individual randomisation, published in four frequently cited journals between 2003 and 2005. We evaluated the type of outcome, the frequency of reporting NNTs with corresponding confidence intervals, and assessed the adequacy of the methods used to calculate NNTs in the case of time-to-event outcomes.

Results

The search resulted in 734 eligible RCTs. Of these, 373 RCTs investigated time-to-event outcomes and 361 analyzed binary data. In total, 62 articles reported NNTs (34 articles with time-to-event outcomes, 28 articles with binary outcomes). Of the 34 articles reporting NNTs derived from time-to-event outcomes, only 17 applied an appropriate calculation method. Of the 62 articles reporting NNTs, only 21 articles presented corresponding confidence intervals.

Conclusion

The NNT is used as effect measure to present the results from RCTs with binary and time-to-event outcomes in the current medical literature. In the case of time-to-event data incorrect methods were frequently applied. Confidence intervals for NNTs were given in one third of the NNT reporting articles only. In summary, there is much room for improvement in the application of NNTs to present results of RCTs, especially where the outcome is time to an event.