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    Area of Science:

    • Clinical Research Methodology
    • Multisite Study Design
    • Process Improvement in Research

    Background:

    • Multisite studies offer expanded sample sizes and diversity for capturing real-world clinical practices.
    • Challenges in multisite research include site recruitment, sampling variability, inter-site practice differences, and data integrity.
    • Proactive strategies are essential to enhance the rigor and reproducibility of multisite investigations.

    Purpose of the Study:

    • To describe a cascading approach for conducting multisite research.
    • To present an exemplar study evaluating pain prevalence and management in pediatric intensive care units (PICUs) using this approach.

    Main Methods:

    • The cascading approach involves sequential pilot studies with progressively more sites.
    • Each pilot phase includes evaluation, feedback collection from site personnel and experts, procedural revision, and site training.
    • Revised procedures are then implemented in a larger, more diverse cohort of sites.

    Main Results:

    • The exemplar study demonstrated improved data collection efficiency and integrity in the full-scale phase following pilot testing.
    • Consistent site participation was maintained throughout the pilot and full-scale study phases.

    Conclusions:

    • The cascading approach, inspired by process improvement, facilitates knowledge acquisition on site-specific variations.
    • This methodology aids in refining study procedures, optimizing efficiency and data integrity, minimizing participant burden, and sustaining site engagement in multisite research.