Evidence-based Pediatric Orthopaedics: How Safe is “Safe”?
The aim of minimizing the risks of complications and adverse events is at the center of surgical practice.Background:
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: