The importance of having a conceptual stage when reporting non-randomized studies

Formal guidelines for statistical reporting of non-randomized studies are important for journals that publish results of such studies. Although it is gratifying to see some journals providing guidelines for statistical reporting, we feel that the current guidelines that we have seen are not entirely adequate when the study is used to draw causal conclusions. We therefore offer some comments on ways to improve these studies. In particular, we discuss and illustrate what we regard as the need for an essential initial stage of any such statistical analysis, the conceptual stage, which formally describes the embedding of a non-randomized study within a hypothetical randomized experiment.