Interpreting the results of a clinical trial

Keech, Anthony C; Pike, Rhana; Granger, Renee E; Gebski, Val J

doi:10.5694/j.1326-5377.2007.tb00911.x

Topics

Statistics, epidemiology and research design

In preparing an article reporting a clinical trial, the authors are expected to provide a reasoned interpretation of the results and place them into a broader clinical context. “Interpretation” (Item 20 of the CONSORT statement) refers to how the authors account for their results (Box 1).1

NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW.

Correspondence: tony@ctc.usyd.edu.au

Competing interests:

None identified.

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. Montori VM, Jaeschke R, Schunemann HJ, et al. Users’ guide to detecting misleading claims in clinical research reports. BMJ 2004; 329: 1093-1096.
3. Gebski V, Marschner I, Keech AC. Specifying objectives and outcomes for clinical trials. Med J Aust 2002; 176: 491-492. <MJA full text>
4. Burgess DC, Gebski VJ, Keech AC. Baseline data in clinical trials. Med J Aust 2003; 179: 105-107. <MJA full text>
5. Beller EM, Gebski V, Keech AC. Randomisation in clinical trials. Med J Aust 2002; 177: 565-567. <MJA full text>
6. Kirby A, Gebski V, Keech AC. Determining the sample size in a clinical trial. Med J Aust 2002; 177: 256-257. <MJA full text>
7. Cook DI, Gebski VJ, Keech AC. Subgroup analysis in clinical trials. Med J Aust 2004; 180: 289-291. <MJA full text>
8. Simes RJ, Gebski VJ, Keech AC. Subgroup analysis: application to individual patient decisions. Med J Aust 2004; 180: 467-469. <MJA full text>
9. Seale JP, Gebski VJ, Keech AC. Generalising the results of trials to clinical practice. Med J Aust 2004; 181: 558-560. <MJA full text>
10. Keech AC, Wonders SM, Cook DI, Gebski VJ. Balancing the outcomes: reporting adverse events. Med J Aust 2004; 181: 215-218. <MJA full text>
11. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med 1998; 339: 1349-1357.
12. Loten C, Stokes B, Worsley D, et al. A randomised controlled trial of hot water (45°C) immersion versus ice packs for pain relief in bluebottle stings. Med J Aust 2006; 184: 329-333. <MJA full text>
13. Ursin G, Bernstein L, Lord SJ, et al. Reproductive factors and subtypes of breast cancer defined by hormone receptor and histology. Br J Cancer 2005; 93: 364-371.
14. Collins R, Armitage J, Parish S, et al; Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet 2003; 361: 2005-2016.
15. Horton R. The hidden research paper. JAMA 2002; 287: 2775-2778.

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