The Statistical Fragility of Platelet-Rich Plasma in Rotator Cuff Surgery: A Systematic Review and Meta-analysis.

BACKGROUND

The practice of evidence-based medicine relies on objective data to guide clinical decision-making with specific statistical thresholds conveying study significance.

PURPOSE

To determine the utility of applying the fragility index (FI) and the fragility quotient (FQ) analysis to randomized controlled trials (RCTs) evaluating the utilization of platelet-rich plasma (PRP) in rotator cuff repairs (RCRs).

STUDY DESIGN

Systematic review and meta-analysis.

METHODS

RCTs pertaining to the utilization of PRP in surgical RCRs published in 13 peer-reviewed journals from 2000 to 2020 were evaluated. The FI was determined by manipulating each reported outcome event until a reversal of significance was appreciated. The associated FQ was determined by dividing the FI by the sample size.

RESULTS

Of the 9746 studies screened, 19 RCTs were ultimately included for analysis. The overall FI incorporating all 19 RCTs was only 4, suggesting that the reversal of only 4 events is required to change study significance. The associated FQ was determined as 0.092. Of the 43 outcome events reporting lost to follow-up data, 13 (30.2%) represented lost to follow-up >4.

CONCLUSION

Our analysis suggests that RCTs evaluating PRP for surgical RCRs may lack statistical stability with only a few outcome events required to alter trial significance. Therefore, we recommend the reporting of an FI and an FQ in conjunction with value analysis to carefully interpret the integrity of statistical stability in future comparative trials.

CLINICAL RELEVANCE

Clinical decisions are often informed by statistically significant results. Thus, a true understanding of the robustness of the statistical findings informing clinical decision-making is of critical importance.