Using a Cascading Approach to Improve Multisite Study Procedures.

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.