Translating statistical findings into plain English.

摘要

Clinical trial reports usually give estimates of treatment effects, their confidence intervals, and p values. The statistical methods and their technical meaning are well established. There is less clarity about the concise interpretative wording that authors should use, especially in the abstract and conclusions and by others in commentaries. The following guidance assumes that one short sentence needs to capture the essence of a trial's findings for the primary endpoint. Various scenarios can arise (figure). Scenario A has the treatment effect very highly statistically significant (p<0.001); in, for example, the comparison of everolimus with placebo for progression-free survival in advanced renal-cell carcinoma.1 Such strong evidence provides proof of treatment efficacy beyond reasonable doubt, justifying the statement "everolimus prolongs progression-free survival". However, even extreme p values are not definitive proof.