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J Patient Saf. 2019 Jan 31. doi: 10.1097/PTS.0000000000000564. [Epub ahead of print]

Developing Evidence for New Patient Safety Bundles Through Multihospital Collaboration.

Author information

James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital, Cincinnati, Ohio.
Department of Pharmaceutical Sciences and Office of Quality and Patient Care, St. Jude Children's Research Hospital, Memphis, Tennessee.
Associates in Process Improvement, Austin, Texas.



Multihospital collaboration for safety improvements is increasingly common, but strategies for developing bundles when effective evidence-based practices are not well described are limited. The Children's Hospitals' Solutions for Patient Safety (SPS) Network sought to further reduce patient harm by developing improvement bundles when preliminary evidence was limited.


As part of the novel Pioneer process, cohorts of volunteer SPS hospitals collaborated to identify a harm reduction bundle for carefully selected hospital-acquired harm categories where evidence-based practices were limited. For each harm type, a leadership team selected interventions (factors) for testing and guided the work throughout the Pioneer process. Using fundamental quality improvement techniques and a planned experimentation design, each participating hospital submitted outcome and process compliance data for the factor implemented. Data from all hospitals implementing that factor were analyzed together using Shewhart charts, response plots, and analysis of covariance to identify whether reliable implementation of the factor influenced outcomes. Factors were categorized based on strength of evidence and other clinical or evidentiary support. Factors with strong support were included in a final bundle and disseminated to all SPS hospitals.


The SPS began the bundle identification process for nine harm types and three have completed the process. The analytic approach resulted in four scenarios that along with clinical input guided the inclusion or rejection of the factor in the final bundle.


In this multihospital collaborative, quality improvement methods and planned experimentation were effective at developing evidence-based harm reduction bundles in situations where limited data for interventions exist.

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