Futility of Cluster Designs at Individual Hospitals to Study Surgical Site Infections and Interventions Involving the Installation of Capital Equipment in Operating Rooms

Franklin Dexter, Johannes Ledolter, Richard H. Epstein, Randy W. Loftus

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Article number82
JournalJournal of Medical Systems
Volume44
Issue number4
DOIs
StatePublished - Apr 1 2020

Keywords

  • Cluster randomized trials
  • Operating room management
  • Statistical power analyses
  • Surgical site infection

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Information Systems
  • Health Informatics
  • Health Information Management

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