Evidence-based Pediatric Orthopaedics: How Safe is “Safe”?

BACKGROUND: The aim of minimizing the risks of complications and adverse events is at the center of surgical practice.This study aimed to assess the evidence on which pediatric orthopaedic surgical procedures are described as "safe." In particular, the objective was to ascertain the proportion of studies describing a procedure as "safe," which achieved a 95% upper limit confidence interval of risk of 5% or less for major adverse events. METHOD: A primary search of Journal of Paediatric Orthopaedics 2009 to 2014 for the single term "safe" returned 71 papers appropriate for analysis. Of these, 60 positively identified at least 1 intervention as "safe." These papers were analyzed and the number of interventions and the number of complications recorded. Data sets (n=67) were created and the 95% upper confidence interval calculated for the probability of a complication. RESULTS: Only 16 data sets (ex 67) provided evidence that the probability of a major complication was under 5%. CONCLUSIONS: This work suggests there is widespread failure of understanding of how low sample sizes or can lead to an unjustifiable claim that procedures are "safe. LEVEL OF EVIDENCE: Unclassifiable.