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Evidence-based Pediatric Orthopaedics: How Safe is "Safe"?

G Alexander Augustithis1, Hannah Margaret Ensor, James S Huntley

  • 1*Royal Hospital for Sick Children †Biomathematics and Statistics Scotland, Edinburgh ‡Royal Hospital for Children, Glasgow, UK.

Journal of Pediatric Orthopedics
|March 14, 2017
PubMed
Summary

Many pediatric orthopaedic studies wrongly claim procedures are "safe." A review found most studies lacked sufficient data to support safety claims, highlighting issues with small sample sizes in surgical research.

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Area of Science:

  • Pediatric Orthopaedic Surgery
  • Surgical Safety
  • Evidence-Based Medicine

Background:

  • Minimizing surgical risks is paramount in practice.
  • Assessing the evidence for
  • safe
  • pediatric orthopaedic procedures is crucial.
  • Defining
  • safe
  • requires a low risk of major adverse events (≤5%).

Purpose of the Study:

  • To evaluate the proportion of pediatric orthopaedic studies that adequately support claims of procedural safety.
  • To determine if studies describing procedures as
  • safe
  • met a stringent threshold for major adverse event risk (95% upper confidence limit ≤5%).

Main Methods:

  • A systematic search was conducted in the Journal of Paediatric Orthopaedics (2009-2014) using the keyword
  • safe
  • .
  • 71 relevant papers were identified, with 60 claiming at least one intervention was
  • safe
  • .
  • 67 datasets were analyzed to calculate the 95% upper confidence interval for complication probability.

Main Results:

  • Only 16 out of 67 analyzed datasets provided evidence that the probability of a major complication was below 5%.
  • The vast majority of studies claiming safety did not meet the predefined statistical threshold for low complication rates.

Conclusions:

  • There is a significant failure to understand the statistical limitations of small sample sizes in surgical research.
  • Claims of procedural
  • safety
  • in pediatric orthopaedics are often unsubstantiated due to inadequate evidence.
  • Further research is needed to ensure robust safety reporting in surgical literature.