The Fragility of Statistical Findings in Meniscus Repair Literature: A Systematic Review of Randomized Controlled Trials.

Abstract

Background: Within the realm of orthopedic literature, the determination of statistical significance for outcomes relies on probability analysis and the reporting of P-values. The aim of this study was to employ fragility analysis as a means of evaluating the resilience of randomized controlled trials (RCTs) that assess meniscus surgeries. It was hypothesized that dichotomous outcomes would be statistically fragile and comparable to other orthopedic specialties.

Methods: Included in this study were RCTs reporting dichotomous measures pertaining to meniscus repair, sourced from 14 orthopedic journals indexed on PubMed between 2000 and 2022. The fragility index (FI) for each outcome was determined by iteratively reversing a single outcome event until the significance was reversed. To calculate the fragility quotient (FQ), the FI of each study was divided by its respective sample size. Additionally, the interquartile range (IQR) was calculated for both the FI and FQ.

Results: Out of the 7,844 articles screened, a total of 17 RCTs with 112 dichotomous outcomes were included for analysis. The FI for all the outcomes was 7, with an IQR of 4 to 10. Similarly, the FQ was 0.067, with an IQR of 0.029 to 0.107. However, statistically significant outcomes had a FI and FQ of 4 (IQR 2 to 7) and .057 (IQR 0.03 to 0.108), respectively. The average number of patients lost to follow-up was 2 patients and 17.6% of studies reporting lost to follow up of 7 or greater.

Conclusion: Recent findings suggest that the stability of the literature concerning meniscus repair may not be as robust as previously assumed. Consequently, we strongly advocate for the inclusion of the FI and FQ metrics, alongside the P-value, to enhance the interpretation of clinical findings presented in the meniscus repair literature. Level of Evidence: I.