, Volume 32, Issue 3, pp 221-226

New directions in clinical outcomes assessment

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In recent years, electrophysiology clinical research has made tremendous progress. Not only have the standards for conducting research and assessing clinical outcomes improved substantially, but the power of well-conducted and designed randomized clinical trials has been realized. This has led to the emergence of a plethora of randomized clinical trials in electrophysiology. Despite these improvements, there is an immense need to explore and develop better approaches for assessing clinical outcomes. In this article, I review the strengths, challenges, and limitations of randomized clinical trials, especially as they relate to the field of electrophysiology. To address some of these challenges, I propose potential solutions that involve enhancing clinical trials and complementing them with large registries and databases of electronic medical records. If prudently developed and executed, these new directions in assessing clinical outcomes have great potential to inform, and thereby improve the care of patients receiving electrophysiologic interventions.

This study is an educational collaboration among the Electrophysiology Research Foundation, New Jersey, University of Bonn, Bonn, Germany and the University of Medicine and Dentistry New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey.