Fragility Index and Fragility Quotient in Randomized Controlled Trials on Corticosteroids in ARDS Due to COVID-19 and Non-COVID-19 Etiology

Vargas, Maria; Marra, Annachiara; Buonanno, Pasquale; Coviello, Antonio; Iacovazzo, Carmine; Servillo, Giuseppe

doi:10.3390/jcm10225287

Cited by 8 publications

(6 citation statements)

References 36 publications

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“…The FI has been reported for a number of medical and surgical RCTs, including cerebrovascular surgery, 2 critical care, 4 , 41 nephrology, 42 hand surgery, 5 and cardiovascular trials. 43 To the authors’ knowledge, this is the first study to evaluate the FI for interventional radiology trials.…”

Section: Discussionmentioning

confidence: 99%

The reproducibility of interventional radiology randomized controlled trials and external validation of a classification system

Aslan¹,

Stevens²,

Aldine³

et al. 2023

dir

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The fragility index (FI) measures the robustness of randomized controlled trials (RCTs). It complements the P value by taking into account the number of outcome events. In this study, the authors measured the FI for major interventional radiology RCTs. METHODSInterventional radiology RCTs published between January 2010 and December 2022 relating to trans-jugular intrahepatic portosystemic shunt, trans-arterial chemoembolization, needle biopsy, angiography, angioplasty, thrombolysis, and nephrostomy tube insertion were analyzed to measure the FI and robustness of the studies. RESULTSA total of 34 RCTs were included. The median FI of those studies was 4.5 (range 1-68). Seven trials (20.6%) had a number of patients lost to follow-up that was higher than their FI, and 15 (44.1%) had a FI of 1-3. CONCLUSIONThe median FI, and hence the reproducibility of interventional radiology RCTs, is low compared to other medical fields, with some having a FI of 1, which should be interrupted cautiously.

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Section: Discussionmentioning

confidence: 99%

The reproducibility of interventional radiology randomized controlled trials and external validation of a classification system

Aslan¹,

Stevens²,

Aldine³

et al. 2023

dir

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“…Statistical fragility is poorly understood, with no consensus on cut-offs to determine whether a study is significantly fragile or robust. However, multiple studies have shown high fragility in the medical literature (3,7,8).…”

Section: Discussionmentioning

confidence: 99%

A Comparative Analysis of Unit Fragility and the Relative Risk Index

Heston

2023

Preprint

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BACKGROUND: In biostatistics, evaluating fragility is crucial for understanding their vulnerability to miscategorization. One proposed measure of statistical fragility is the unit fragility index (UFI), which measures the susceptibility of the p-value to flip significance with minor changes in outcomes. Although the UFI provides valuable information, it relies on p-values, which are arbitrary measures of statistical significance. Alternative measures, such as the fragility quotient (FQ) and the percent fragility index, have been proposed to decrease the UFI’s reliance on sample size. However, these approaches still rely on p-values and thus depend on an arbitrary cutoff of p < 0.05. Instead of quantifying fragility by relying on p-values, this study evaluated the effect of small changes on relative risk. METHODS: Random 2x2 contingency tables associated with an initial p-value of 0.001 to 0.05 were evaluated. Each table’s UFI and relative risk index (RRI) were calculated. A derivative of the RRI, the percent RRI, was also calculated along with the FQ. The UFI, FQ, RRI, pRRI, initial p-value, and sample size were compared. RESULTS: A total of 15000 cases were tested. The correlation between the UFI and the p-value was the strongest (r = -0.807), and the correlation between the pRRI was the weakest (r = -0.395). The RRI had the strongest correlation with the sample size (r = 0.826), and the UFI had the weakest correlation (r = 0.3904). The coefficient of variation for the average RRI was the smallest at 28.3%, and for the FQ, it was the greatest at 57.0%. The correlation between the UFI, FQ, and p-value is significantly greater than the correlation between the RRI, pRRI, and p-value (for all comparisons, p < 0.001). CONCLUSION: The RRI and pRRI are significantly less correlated with the p-value than the UFI and FQ, indicating relative independence of the RRI and pRRI from p-values.

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“…This indicates that, on average, half a percent of study participants would need to have their outcomes changed from an event to a non-event for the trial results to turn from statistically significant to statistically not significant. In other words, the FQ provides a measure of how sensitive trial results are to changes in a small number of participants [37,38]. A low FQ value means that a trial result is relatively robust and not overly sensitive to small changes in the number of outcomes, and vice versa.…”

Section: Fragility Indexmentioning

confidence: 99%

Assessing the robustness of COVID-19 vaccine efficacy trials: systematic review and meta-analysis, January 2023

et al. 2023

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Background Vaccines play a crucial role in the response to COVID-19 and their efficacy is thus of great importance. Aim To assess the robustness of COVID-19 vaccine efficacy (VE) trial results using the fragility index (FI) and fragility quotient (FQ) methodology. Methods We conducted a Cochrane and PRISMA-compliant systematic review and meta-analysis of COVID-19 VE trials published worldwide until 22 January 2023. We calculated the FI and FQ for all included studies and assessed their associations with selected trial characteristics using Wilcoxon rank sum tests and Kruskal–Wallis H tests. Spearman correlation coefficients and scatter plots were used to quantify the strength of correlation of FIs and FQs with trial characteristics. Results Of 6,032 screened records, we included 40 trials with 54 primary outcomes, comprising 909,404 participants with a median sample size per outcome of 13,993 (interquartile range (IQR): 8,534–25,519). The median FI and FQ was 62 (IQR: 22–123) and 0.50% (IQR: 0.24–0.92), respectively. FIs were positively associated with sample size (p < 0.001), and FQs were positively associated with type of blinding (p = 0.023). The Spearman correlation coefficient for FI with sample size was moderately strong (0.607), and weakly positive for FI and FQ with VE (0.138 and 0.161, respectively). Conclusions This was the largest study on trial robustness to date. Robustness of COVID-19 VE trials increased with sample size and varied considerably across several other important trial characteristics. The FI and FQ are valuable complementary parameters for the interpretation of trial results and should be reported alongside established trial outcome measures.

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Fragility Index and Fragility Quotient in Randomized Controlled Trials on Corticosteroids in ARDS Due to COVID-19 and Non-COVID-19 Etiology

Cited by 8 publications

References 36 publications

The reproducibility of interventional radiology randomized controlled trials and external validation of a classification system

The reproducibility of interventional radiology randomized controlled trials and external validation of a classification system

A Comparative Analysis of Unit Fragility and the Relative Risk Index

Assessing the robustness of COVID-19 vaccine efficacy trials: systematic review and meta-analysis, January 2023

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