Abstract

In medical research, it is not unusual that risks are ruled out without any specification the exact risk that was ruled out. This makes it difficult to balance expected health benefits and risk of harm when choosing between alternative treatment options. International guidelines for reporting medical research results are sufficiently specific when it comes to establishing health benefits. However, there is a lack of standards for reporting on ruling out risks. We argue that transparency is needed, as in the case of non-inferiority trials. The Consolidated Standards of Reporting Trials and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements should be revised accordingly.