Expanding the CONSORT Figure: Increasing Transparency in Reporting on External Validity.

INTRODUCTION: There are major problems with failure to replicate research findings. Contributing to this problem is a failure to report on factors related to external validity. Frequently, researchers have little knowledge whether findings apply more generally, especially to low-resource settings and underserved populations. The CONSORT flow diagram has improved reporting on variables related to internal validity, but it has very limited detail on issues related to external validity. A recent CONSORT update and other publications have called for more transparent reporting on external validity and context, and information regarding the sustainability of interventions. All of these elements influence the generalizability of findings from outcomes research.
METHODS: Drawing on theory, a prior meeting, and recent recommendations for reporting factors related to external validity, the authors propose an expansion of the basic CONSORT flow diagram for clinical trials to concisely summarize these data that recent CONSORT statements and other guidelines have recommended.
RESULTS: The authors propose the use of an expanded CONSORT figure and illustrate its utility with an example. The expanded CONSORT figure adds data about participation and representativeness at the levels of settings and staff, and about intervention sustainability after project support ends. The authors provide an expanded CONSORT figure reporting template, and demonstrate its use.
CONCLUSIONS: Improving transparent reporting on external validity by using the proposed expanded CONSORT figure would help to address both the scientific replication crisis and health equity concerns. This figure provides a method to efficiently address the representativeness, generalizability, and sustainability of outcomes research.