Journal of evaluation in clinical practice
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Meta Analysis
Clinical effectiveness in cardiovascular trials in relation to the importance to the patient of the end-points measured.
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. ⋯ The proportion of interventions tested in the cardiovascular trials considered in this study that have a substantial beneficial effect relative to the control decreases as the end-point used to measure this effect becomes more important to the patient, that is, as the end-point severity increases from minor outcome to major outcome to death. Also, the analysis presented in this study strongly suggests that most of these interventions are likely to have close to no genuine effect on mortality relative to the control. Overall, this study substantially strengthens the empirical basis for the belief that the actions of trialists in choosing to study and heavily emphasize end-points other than mortality in cardiovascular trials and in particular end-points that are of only moderate or major importance to patients, may mislead practitioners and policy-makers about the overall effectiveness of the intervention concerned.