CC2021: The Statistical Fragility of Platelet-Rich Plasma in Rotator Cuff Surgery (October 2021)-CC2021: The Statistical Fragility of Platelet-Rich Plasma in Rotator Cuff Surgery (October 2021)

CC2021: The Statistical Fragility of Platelet-Rich Plasma in Rotator Cuff Surgery (October 2021)

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This study aimed to determine the utility of applying the fragility index (FI) and the fragility quotient (FQ) analysis to randomized controlled trials (RCTs) evaluating the use of platelet-rich plasma (PRP) in rotator cuff repairs (RCRs). A systematic review and meta-analysis were conducted on RCTs published between 2000 and 2020. Out of 9,746 studies screened, 19 RCTs were 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. The analysis suggests that RCTs evaluating PRP for surgical RCRs may lack statistical stability, with only a few outcome events required to alter trial significance. Recommendations include reporting an FI and an FQ in conjunction with P value analysis to carefully interpret the integrity of statistical stability in future comparative trials. The fragility index is a numerical representation of the concept that describes the reversal of significance with a small number of outcome events. The fragility quotient accounts for the sample size and provides a relative measure of fragility and quantitative significance. The study highlights the limitations of relying solely on P values and the need for more robust reporting of statistical stability in RCTs.

Keywords

fragility index

fragility quotient

platelet-rich plasma

rotator cuff repairs

randomized controlled trials

systematic review

meta-analysis

statistical stability

outcome events

comparative trials