Clinical Research Reporting Paradigms May Incompletely Describe Participant Identities

Music City Center 

Reporting of participants' baseline characteristics in clinical research is important for understanding a given study's context and typically occurs in a tabular format. However, this format incompletely and ambiguously describes included participants, as their identities are more fully represented by an intersecting set of sociodemographic characteristics rather than discrete characteristics in a table. Standard tabular reporting practices therefore introduce limitations in assessing a study's representativeness as well as its internal validity and external validity. To address this, we propose the addition of a simple graph that more clearly shows the joint distribution of baseline sociodemographic characteristics in a given study. We also discuss several practical considerations for the implementation of such graphs in the communication of clinical research.

health equity

clinical trial

observational study

internal validity

external validity

data reporting 

Health Policy Statistics Section