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Related Experiment Videos

Detecting Anomalies Among Practice Sites Within Multicenter Trials.

Seth A Berkowitz1,2, Kara E Rudolph3, Sanjay Basu4,5,6,7,8

  • 1Division of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill (S.A.B.).

Circulation. Cardiovascular Quality and Outcomes
|March 13, 2019
PubMed
Summary

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Transportability methods effectively identified site anomalies in multicenter trials that standard methods missed. This new approach helps distinguish participant differences from potential site performance issues, improving trial validity.

Area of Science:

  • Clinical Trials
  • Biostatistics
  • Cardiovascular Disease Research

Background:

  • Multicenter trials often show significant result variations between sites.
  • These heterogeneities may stem from participant population differences or site-specific protocol deviations.
  • Investigating these anomalies is crucial for maintaining study validity and accurate treatment effect assessment.

Purpose of the Study:

  • To evaluate the efficacy of transportability methods in detecting site anomalies within multicenter randomized trials.
  • To compare the performance of transportability methods against standard statistical approaches for anomaly detection.
  • To determine if observed treatment-effect heterogeneities are attributable to participant characteristics or site performance.

Main Methods:

Keywords:
blood pressurecardiovascular systemheart failuremethodologyreproducibility

Related Experiment Videos

  • Applied transportability methods to two large cardiovascular trials: TOPCAT and ACCORD BP.
  • Utilized calibration tests to assess if participant covariates explained between-site differences in treatment effects.
  • Compared results from transportability methods with standard regression analyses.

    • Main Results:

    • Standard methods failed to detect significant heterogeneities in the TOPCAT trial between Russia/Georgia and Americas sites.
    • Transportability methods identified significant discrepancies (P<0.001) between these TOPCAT sites, not explained by participant characteristics.
    • Transportability methods found no significant discrepancies in the ACCORD BP trial, indicating participant characteristics explained site variations.

    Conclusions:

    • Transportability methods demonstrate superiority over standard approaches for detecting anomalies in multicenter trials.
    • These methods aid data monitoring boards in differentiating between participant-driven and site-performance-related heterogeneities.
    • Enhanced anomaly detection improves the reliability and validity of findings from multicenter randomized trials.