Clinical effectiveness in cardiovascular trials in relation to the importance to the patient of the end-points measured.

Journal of Evaluation in Clinical Practice
Russell J Bowater, Richard J Lilford

Abstract

In order to increase the statistical power of a trial design, it is common practice for trialists to place a strong emphasis on end-points other than mortality. To assess the validity of this practice, the aim of this study was to investigate the relationship between the effectiveness of cardiovascular interventions in clinical trials and the importance to the patient of the end-point used to measure this effectiveness. A reanalysis of a database of cardiovascular trials used in an earlier study. This database consists of all randomized controlled trials published in six leading journals for cardiovascular research between January 2002 and June 2003 that involve the exposure of humans to any therapeutic or primary preventive intervention for cardiovascular disease and report at least one composite end-point. On the basis of analysing the study data using a statistical modelling approach, the best estimate of the percentage of trials that have a true (not estimated) relative risk of less than 0.8 for the end-point of moderate outcome, major outcome and death are 63%, 39% and 0% respectively, and the upper 95% confidence limits on these three percentages are 73%, 43% and 15% respectively. The proportion of interventions tested in...Continue Reading

References

Sep 1, 1986·Controlled Clinical Trials·R DerSimonian, N Laird
Jul 12, 2002·Statistics in Medicine·Julian P T Higgins, Simon G Thompson
May 22, 2003·JAMA : the Journal of the American Medical Association·Nick FreemantleCarl Griffin
Oct 19, 2005·Journal of Cardiac Failure·James D NeatonMarvin A Konstam
Apr 4, 2007·BMJ : British Medical Journal·Ignacio Ferreira-GonzálezGordon H Guyatt

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Citations

Sep 15, 2012·BMJ Quality & Safety·Guiqing Lily YaoUNKNOWN European HANDOVER Research Collaborative
Jul 29, 2011·Journal of Evaluation in Clinical Practice·Andrew Miles, Michael Loughlin

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