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Clinical Research Reporting Paradigms May Incompletely Describe Participant Identities
M Enache Oana1, Goldman Rosas Lisa2, Rose Sherri3
1Department of Biomedical Data Science, Stanford University.
Abstract:
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.
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