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Editorial Commentary: High Level of Evidence Randomized Controlled Trials May Report Statistically Fragile
1The Steadman Clinic & Steadman Philippon Research Institute.
Abstract:
Randomized controlled trials (RCTs) are considered the gold standard for evidence-based medicine, and although a well-designed and executed RCT can be extremely powerful, many RCTs have significant flaws that may significantly impact the strength of their conclusions. The fragility index is a metric that objectifies the strength of results from RCTs and is one such metric that should be considered when critically evaluating individual studies. Although the RCTs pertaining to hip arthroscopy have a median value of 4, which is slightly greater than other orthopaedic subspecialties investigated thus far, this is far from a robust result, which mostly highlights the difficulty in performing an RCT in the surgical realm. Some topics of investigation may be better suited for well performed case-control, matched cohort, and meta-analysis studies (among other investigation types), which may provide better and more robust conclusions than a poorly performed RCT. In essence, don't be enamored by level of evidence alone.

