Statement on matching language to the type of evidence used in describing observational studies vs. randomized trials

Abstract

See page 7 for the editorial comment on this article (doi:10.1093/eurheartj/ehs387) Observational studies and randomized controlled trials (RCTs) provide different types of evidence for the evaluation of a therapeutic intervention. Each has advantages and disadvantages. As illustrated in a series of examples in a separate review,1 interpretation of observational studies, which are relatively descriptive, can be confounded and rendered ambiguous by the fact that many variables impacting outcomes can differ between groups. Therefore, such studies cannot necessarily establish causality. When RCTs are performed using standard design characteristics, the intervention under study is the only variable that differs between the groups. As such, RCTs are much better suited to establish causality in the specific population studied than observational studies. Therefore, it is important to carefully select the language used to report each type of study in order to foster the most accurate data interpretation by the reader. The Editors of the Heart Group (representing the world's cardiovascular journals) recommend that all investigators and editors carefully select language to ‘match’ the type of study conducted (observational vs. randomized) without overstating findings or drawing erroneous conclusions about causality when they cannot be rigorously established.

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