Background: There is a movement to ensure that pediatric patients are treated in appropriately resourced hospitals through the ACS Children's Surgery Verification (CSV) program. The objective of this study was to assess the potential difference in care provision, health outcomes and healthcare and societal costs after implementation of the CSV program.
Methods: All 2011 inpatient admissions for selected complex pediatric patients warranting treatment at a hospital with Level I resources were evaluated across 6 states. Multivariate regressions were used to analyze differences in healthcare outcomes (postoperative complications including death, length of stay, readmissions and ED visits within 30 days) and costs by CSV level. Recycled predictions were used to estimate differences between the base case scenario, where children actually received care, and the optimized scenario, where all children were theoretically treated at Level I centers.
Results: 8,006 children (mean age 3.06 years, SD 4.49) met inclusion criteria, with 45% treated at Level I hospitals, 30% at Level II and 25% at Level III. No statistically significant differences were observed in healthcare outcomes. Readmissions within 30 days were higher at Level II compared to Level I centers (adjusted IRR 1.61; 95% CI 1.11, 2.34), with an estimated 24 avoidable readmissions per 1000 children if treatment were shifted from Level II to Level I centers. Overall, costs per child were not significantly different between the base case and the optimized scenario.
Conclusion: Many complex surgical procedures are being performed at Level II/III centers. This study found no statistically significant increase in healthcare or societal costs if these were performed instead at Level I centers under the optimized scenario. Ongoing evaluation of efforts to match institutional resources with individual patient needs is needed to optimize children's surgical care in the United States.
Level Of Evidence: II.
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http://dx.doi.org/10.1016/j.jpedsurg.2018.10.102 | DOI Listing |
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Global harmonization of biosimilar developmental requirements will facilitate development leading to increased patient and societal benefits. However, there are several technical and regulatory hurdles that must be addressed to harmonize the regulatory requirements in different countries and regions. At times, there is a requirement for use of locally sourced reference product, forcing biosimilar developers to repeat analytical or clinical comparability studies against reference product batches sourced from within a given country.
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Independent Researcher, The Hague, Netherlands.
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