Examination of participant flow in the CONSORT diagram can improve the understanding of the generalizability of study results

Abstract

A fundamental principle in research is that the findings of a study can only be generalized to the population from which the sample of the study was drawn. What this population was can be discerned from an examination of the study selection criteria. Additional insights can sometimes be gleaned from the study flowchart or CONSORT diagram, which may show sample attenuation between subject screening and final recruitment. Such sample attenuation, if present, implies further limitation to the generalizability of the study outcomes. Two large, 2-year, randomized controlled maintenance therapy trials are described to illustrate sample attenuation that limits study generalizability, one in the context of mindfulness-based cognitive therapy versus antidepressant drugs for recurrent major depressive disorder and the other in the context of quetiapine versus placebo for bipolar disorder. Readers therefore need to examine both study selection criteria and the CONSORT diagram in order to better understand the extent to which study results apply to the patients whom they see.