Appropriate statistical methods for analysing trial data are critical for the correct interpretation of the results. Item 12 of the CONSORT statement (Box 1) relates to the statistical methods used in the reporting of trials, together with scientific and statistical principles concerning analyses of subgroups, endpoints and appropriate statistical tests. These issues need to be carefully considered before beginning a study and should be outlined in a standard trial protocol, which may be supplemented by a more extensive statistical analysis plan.1
The full article is accessible to AMA members and paid subscribers. Login to read more or purchase a subscription now.
Please note: institutional and Research4Life access to the MJA is now provided through Wiley Online Library.
- 1. Altman DG, Schulz KF, Moher D, et al, for the CONSORT group. The revised CONSORT statement for reporting randomised trials: explanation and elaboration. Ann Intern Med 2001; 134: 663-694.
- 2. Gebski V, Marschner I, Keech AC. Specifying objectives and outcomes for clinical trials. Med J Aust 2002; 176: 491-492. <eMJA full text>
- 3. Kirby A, Gebski V, Keech A. Determining the sample size in a clinical trial. Med J Aust 2002; 176: 256-257.<eMJA full text>
- 4. Gebski V, Beller E, Keech AC. Randomised controlled trials, the elements of a good study. Med J Aust 2001; 175: 272-274.
- 5. Woodward M. Epidemiology: study design and data analysis. Boca Raton: Chapman and Hall/CRC Press, 1999.
- 6. Delaney G, Rus M, Gebski V, et al. An Australasian assessment of the basic treatment equivalent model derived from NSW data. Australas Radiol 1999; 43: 500-506.
- 7. Simes RJ, Greatorex V, Gebski VJ. Practical approaches to minimise problems with missing quality of life data. Stat Med 1998; 17: 725-737.
- 8. Hollander M, Wolf D. Nonparametric statistical methods. 2nd Ed. New York: John Wiley and Sons, 1999.
- 9. Martin G. Munchausen's statistical grid, which makes all trials significant. Lancet 1984; ii: 1457.
None identified.