Authors of articles reporting clinical trials should discuss the results of their trial in the context of existing evidence. This approach is encouraged by the CONSORT statement (Box 1).1 A trial’s contribution to the evidence can be pinpointed by seeking answers to questions such as:
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- 1. Altman DG, Schulz KF, Moher D, 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. Evans A, Kalra L. Are the results of randomized controlled trials on anticoagulation in patients with atrial fibrillation generalizable to clinical practice? Arch Intern Med 2001; 161: 1443-1447.
- 3. WHI Investigators. Risks and benefits of estrogen and progestin in healthy postmenopausal women. JAMA 2002; 288: 321-333.
- 4. HRT: what are women (and their doctors) to do [editorial]? Lancet 2004; 346: 2069-2070.
- 5. Early Breast Cancer Trialists’ Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 1998; 351: 1451-1467.
- 6. Gebski V, Lagleva M, Keech A, et al. Survival effects of postmastectomy adjuvant radiation therapy using biologically equivalent doses: a clinical perspective. J Natl Cancer Inst 2006; 98: 26-38.
- 7. Cholesterol Treatment Trialists’ (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins. Lancet 2005; 366: 1267-1278.
- 8. Keech A, Colquhoun D, Best J, et al, for the LIPID Study Group. Secondary prevention of cardiovascular events with long-term pravastatin in patients with diabetes or impaired fasting glucose: results from the LIPID trial. Diabetes Care 2003; 26: 2713-2721.
- 9. Hague W, Forder P, Simes J, et al; LIPID Investigators. Effect of pravastatin on cardiovascular events and mortality in 1516 women with coronary heart disease: results from the Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) Study. Am Heart J 2003; 145: 643-651.
- 10. Charles DHM, Ness AR, Campbell D, et al. Folic acid supplements in pregnancy and birth outcome: re-analysis of a large randomised controlled trial and update of Cochrane review. Paediatr Perinat Epidemiol 2005; 19: 112-124.
- 11. Breast International Group (BIG) 1-98 Collaborative Group. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med 2005; 353: 2747-2757.
- 12. Simes RJ, Coates AS. Patient preferences for adjuvant chemotherapy of early breast cancer: how much benefit is needed? J Natl Cancer Inst Monogr 2001; 30: 146-152.
- 13. Seale JP, Gebski VJ, Keech AC. Generalising the results of trials to clinical practice. Med J Aust 2004; 181: 558-560. <MJA full text>
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