Innovative Use of Existing Public and Private Data Sources for Postmarketing Surveillance of Central Line-Associated Bloodstream Infections Associated With Intravenous Needleless Connectors.
Ying P Tabak, Richard S Johannes, Xiaowu Sun and 2 others
PMID 27598072WHAT IT FOUND
Hospitals using a new needleless connector showed no significant difference in central line infection rates compared to those using other connectors.
The new device met statistical criteria for noninferiority, meaning it was not associated with higher infection risks.
Key findings
01The adjusted relative risk for central line-associated bloodstream infections in hospitals using the study needleless connector was 0.94 compared to comparator hospitals, which was not statistically significant.
02The upper limit of the confidence interval for the relative risk was below the noninferiority margin of 1.23, meeting the statistical criterion for noninferiority.
03Sensitivity analyses restricted to hospitals with high-frequency or high-volume use of the study connector produced results consistent with the overall finding of no significant difference.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The study relied on hospital-level data rather than patient-level data, so it could not fully adjust for individual patient risk factors. Researchers did not have access to data on which specific connectors comparator hospitals used, only that they did not use the study device. The study could not confirm if hospitals used the study connector exclusively or mixed it with other devices, though sensitivity analyses suggested this did not change the results.
Declared interests
Several authors were employed by CareFusion, the manufacturer of the study device. One author served as an unpaid consultant and coauthor.
The easy way to misread this
Do not interpret the noninferiority result as proof that the new connector reduces infection rates. The study only demonstrated that it did not increase them compared to existing devices.