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

G. Alexander Augustithis, Hannah Margaret Ensor, James S. Huntley

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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.”
Original languageEnglish
Pages (from-to)e440-e445
JournalJournal of Pediatric Orthopaedics
Volume37
Issue number7
DOIs
Publication statusPublished - 1 Oct 2017

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