Prevention. How much harm? How much benefit? 2. Ten potential pitfalls in determining the clinical significance of benefits.

Abstract

A preventive program is only of value if it has proven benefits that outweigh any adverse consequences; unfortunately, determination of the clinical significance of reported benefits is not always easy. The first article of this series discussed the confusion caused by reporting results in terms of relative rates. In this article, 10 other pitfalls that may lead to misunderstanding of the degree of benefits are reviewed. These pitfalls are: the type of outcome chosen (surrogate v. clinically significant), the risk level in the population screened, the interval between the intervention and the benefit, the duration of intervention required to achieve the benefit, the overshadowing of one benefit by another, the application of a benefit for one variant of a disease to another variant, lower benefits in community settings than in clinical trials, publication bias, preferential citation of studies showing beneficial effects and "false-negative" results of studies. These pitfalls are illustrated through examples from the current medical literature.