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

Russell E Glasgow1, Amy G Huebschmann2, Ross C Brownson3

  • 1Department of Family Medicine, University of Colorado School of Medicine, Aurora, Colorado; University of Colorado Adult and Child Consortium of Outcomes Research and Delivery Science Program, Aurora, Colorado.

American Journal of Preventive Medicine
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Summary

Researchers propose an expanded CONSORT flow diagram to improve reporting on external validity and generalizability in clinical trials. This enhanced figure addresses representativeness and sustainability, aiding replication and health equity.

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Area of Science:

  • Clinical Trials Methodology
  • Health Services Research
  • Research Reproducibility

Background:

  • Replication failures in research are a significant problem, partly due to inadequate reporting of external validity factors.
  • Current reporting practices, including the CONSORT flow diagram, offer limited detail on generalizability, especially for low-resource settings and underserved populations.
  • Recent guidelines emphasize the need for transparent reporting on external validity, context, and intervention sustainability to ensure findings' applicability.

Purpose of the Study:

  • To propose an expansion of the CONSORT flow diagram to better report factors influencing external validity in clinical trials.
  • To address the need for concise summarization of data related to generalizability, representativeness, and sustainability.
  • To provide a practical tool for researchers to enhance the transparency of their study's external validity.

Main Methods:

  • Developed an expanded CONSORT flow diagram based on existing theory and recent reporting recommendations.
  • Incorporated data on participant and setting representativeness, staff participation, and intervention sustainability.
  • Illustrated the utility of the expanded figure with a practical example and provided a reporting template.

Main Results:

  • The proposed expanded CONSORT figure effectively summarizes key data related to external validity.
  • Demonstrated the figure's ability to report on participation and representativeness across different levels (settings, staff).
  • Showcased how the figure incorporates information on intervention sustainability beyond project funding.

Conclusions:

  • Implementing the expanded CONSORT figure can significantly improve transparent reporting of external validity.
  • This enhanced reporting method helps address the scientific replication crisis and promotes health equity.
  • The figure offers an efficient way to communicate the representativeness, generalizability, and sustainability of outcomes research findings.