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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.
Insights
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.
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.
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.
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