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Review Process

ASERNIP-S CLASSIFICATION SYSTEM

Following the systematic review of a new surgical procedure a statement is prepared covering the evidence rating and the safety and efficacy of the procedure.  If further research is required to obtain data on either the safety and/or efficacy of the procedure then recommendations will be given regarding the most appropriate method for doing this.

EVIDENCE RATING

• Poor
  
• Average
  
• Good
  

(This gives an idea of the strength, quality, precision and magnitude (where appropriate) of the evidence-base)

The evidence for ASERNIP-S systematic review is classified as Good, Average or Poor, based on the quality and availability of this evidence. High-quality evidence is defined here as having a low risk of bias and no other significant flaws. While high-quality randomised controlled trials are regarded as the best kind of evidence for comparing interventions, it may not be practical or ethical to undertake them for some surgical procedures, or the relevant randomised controlled trials may not yet have been carried out. This means that it may not be possible for the evidence on some procedures to be classified as good.

SAFETY

The surgical procedure under review will be given one of the following safety classifications:

• At least as safe compared to comparator* procedure(s)
  
• Safety cannot be determined
  
• Less safe compared to comparator* procedure(s)

EFFICACY

The surgical procedure under review will be given one of the following efficacy classifications:

• At least as efficacious compared to comparator* procedure(s)
  
• Efficacy cannot be determined
  
• Less efficacious compared to comparator* procedure(s)

RECOMMENDATIONS REGARDING THE NEED FOR FURTHER RESEARCH
In order to strengthen the evidence base regarding the procedure it may be recommended that either:

• an audit be undertaken, or
  
• a controlled clinical trial, ideally with random allocation to an intervention and control group, be conducted.

The Royal Australasian College of Surgeons recognises that it may not always be possible to undertake a controlled clinical trial. Under such circumstances, it is recommended that, at the very least, data be contributed to an audit for further assessment, in collaboration with ASERNIP-S, until such time as a controlled clinical trial is undertaken.

*A comparator may be the current "gold standard" procedure, an alternative procedure, a non-surgical procedure or no treatment (natural history).

Effective July 2001