Determining the sample of participants to be analysed is a crucial step in reporting clinical trials. For such analyses, the gold standard is the “intention-to-treat” principle. The question of which participants are included in the analysis appears as Item 16 of the CONSORT statement (Box 1).1
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- 1. Moher D, Schulz KF, Altman DG, et al, for the CONSORT group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134: 663-694.
- 2. Fisher L, Dixon D, Jerson J, et al. Intention to treat in clinical trials. In: Peace K, editor. Statistical issues in drug research and development. New York: Marcel Dekker, 1990.
- 3. Gillings D, Koch G. The application of the principle of intention-to-treat to the analysis of clinical trials. Clinical Research Bulletin. Basle: Santoz Pharma, September, 1990.
- 4. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomized controlled trials. BMJ 1999; 319: 670-674.
- 5. Kirby A, Gebski VJ, Keech AC. Determining the sample size in a clinical trial. Med J Aust 2002; 177: 256-257. <eMJA full text>
- 6. Sackett D, Gent M. Controversy in counting and attributing events in clinical trials. N Engl J Med 1979; 301: 1410-1412.
- 7. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. Br J Cancer 1976; 34: 585-612.
- 8. Armitage P. Exclusions, losses to follow-up and withdrawals in clinical trials. In: Shapiro SH, Louis TA, editors. Clinical trials. New York: Marcel Dekker, 1983.
- 9. Gail MH. Eligibility, exclusions, losses to follow-up, removal of randomised patients and uncounted events in cancer clinical trials. Cancer Treat Rep 1985; 69: 1107-1113.
- 10. Sandler R, Halabi S, Baron J, et al. A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer. N Engl J Med 2003; 348: 883-890.
- 11. Cameron ID, Cumming RG, Kurrle SE, et al. A randomised trial of hip protector use by frail older women living in their own homes. Injury Prevention 2003; 9: 138-141.
- 12. Cakir B, Gebski V, Keech AC. Flow of participants in randomised studies. Med J Aust 2003; 178: 347-349. <eMJA full text>
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None identified.