Paper Info
Title
Futility of Cluster Designs at Individual Hospitals to Study Surgical Site Infections and Interventions Involving the Installation of Capital Equipment in Operating Rooms.
Abstract
Anesthesia workspaces are integral components in the chains of many intraoperative bacterial transmission events resulting in surgical site infections (SSI). Matched cohort designs can be used to compare SSI rates among operating rooms (ORs) with or without capital equipment purchases (e.g., new anesthesia machines). Patients receiving care in intervention ORs (i.e., with installed capital equipment) are matched with similar patients receiving care in ORs lacking the intervention. We evaluate statistical power of an alternative design for clinical trials in which, instead, SSI incidences are compared directly among ORs (i.e., the ORs form the clusters) at single hospitals (e.g., the 5 ORs with bactericidal lights vs. the 5 other ORs). Data used for parameter estimates were SSI for 24 categories of procedures among 338 hospitals in the State of California, 2015. Estimated statistical power was ≅8.4% for detecting a reduction in the incidence of SSI from 3.6% to 2.4% over 1 year with 5 intervention ORs and 5 control ORs. For ≅80% statistical power, >20 such hospitals would be needed to complete a study in 1 year. Matched paired cluster designs pair similar ORs (e.g., 2 cardiac ORs, 1 to intervention and 1 to control). With 5 pairs, statistical power would be even less than the estimated 8.4%. Cluster designs (i.e., analyses by OR) are not suitable for comparing SSI among ORs at single hospitals. Even though matched cohort designs are non-randomized and thus have lesser validity, matching patients by their risk factors for SSI is more practical.
Year
DOI
Venue
2020
10.1007/s10916-020-01555-0
Journal of Medical Systems
Keywords
DocType
Volume
Surgical site infection, Operating room management, Cluster randomized trials, Statistical power analyses
Journal
44
Issue
ISSN
Citations 
4
0148-5598
0
PageRank 
References 
Authors
0.34
0
4
Name
Order
Citations
PageRank
Franklin Dexter102.03
Johannes Ledolter211.76
Richard H. Epstein353.18
Randy W Loftus400.34