Unbreakable? An analysis of the fragility of randomized trials that support diabetes treatment guidelines

Kruse, Brittany; Vassar, Matt

doi:10.1016/j.diabres.2017.10.007

Cited by 32 publications

(18 citation statements)

References 41 publications

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“…The FI and FQ have since been adopted by a number of researchers in an attempt to add additional clarity to the interpretation of results. [49][50][51] The FI and FQ have also been utilized for orthopedic research, often illustrating a body of literature whose results are far from robust. A recent article by Forrester et al 15 of 23 clinical trials in orthopedic oncology reported a median FI of 2, which the authors attributed to small sample sizes and large losses to follow-up.…”

Section: Discussionmentioning

confidence: 99%

The Fragility of Statistical Significance in Cartilage Restoration of the Knee: A Systematic Review of Randomized Controlled Trials

et al. 2021

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Objective The purpose of this study was to utilize fragility analysis to assess the robustness of randomized controlled trials (RCTs) evaluating the management of articular cartilage defects of the knee. We hypothesize that the cartilage restorative literature will be fragile with the reversal of only a few outcome events required to change statistical significance. Design RCTs from 11 orthopedic journals indexed on PubMed from 2000 to 2020 reporting dichotomous outcome measures relating to the management of articular cartilage defects of the knee were included. The Fragility Index (FI) for each outcome was calculated through the iterative reversal of a single outcome event until significance was reversed. The Fragility Quotient (FQ) was calculated by dividing each FI by study sample size. Additional statistical analysis was performed to provide median FI and FQ across subgroups. Results Nineteen RCTs containing 60 dichotomous outcomes were included for analysis. The FI and FQ of all outcomes was 4 (IQR 2-7) and 0.067 (IQR 0.034-0.096), respectively. The average number of patients lost to follow-up (LTF) was 3.9 patients with 15.8% of the included studies reporting LTF greater than or equal to 4, the FI of all included outcomes. Conclusions The orthopedic literature evaluating articular cartilage defects of the knee is fragile as the reversal of relatively few outcome events may alter the significance of statistical findings. We therefore recommend comprehensive fragility analysis and triple reporting of the P value, FI, and FQ to aid in the interpretation and contextualization of clinical findings reported in the cartilage restoration literature.

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Section: Discussionmentioning

confidence: 99%

The Fragility of Statistical Significance in Cartilage Restoration of the Knee: A Systematic Review of Randomized Controlled Trials

et al. 2021

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“…The median (IQR) RFI at the P = .01 threshold was 12 (7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19) and at the P = .005 threshold was 14…”

Section: Reverse Fragility Index At Different P Value Thresholdsmentioning

confidence: 97%

Application of the Reverse Fragility Index to Statistically Nonsignificant Randomized Clinical Trial Results

Khan

Fonarow

Friede³

et al. 2020

JAMA Netw Open

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“… 26 Another study of 35 RCTs in the 2017 diabetes treatment guidelines reported that the median FI score was 16 (4–29). 27 Analysis of 25 RCTs in heart failure reported a median FI score of 26 (0–118). 16 Compared to these guidelines, RCTs of SSG had moderate robustness having a median FI of 5.5.…”

Section: Discussionmentioning

confidence: 99%

How Robust are the Evidences that Formulate Surviving Sepsis Guidelines? An Analysis of Fragility and Reverse Fragility of Randomized Controlled Trials that were Referred in these Guidelines

Choupoo

Das

Saikia

et al. 2021

Indian Journal of Critical Care Medicine

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A bstract Objectives “Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016” provides guidelines in regard to prompt management and resuscitation of sepsis or septic shock. The study is aimed to assess the robustness of randomized controlled trials (RCTs) that formulate these guidelines in terms of fragility index and reverse fragility index. Method RCTs that contributed to these guidelines having parallel two-group design, 1:1 allocation ratio, and at least one dichotomous outcome were included in the study. The median fragility index was calculated for RCTs with significant statistical outcomes, whereas the median reverse fragility index was calculated for RCTs with nonsignificant statistical results. Results Hundred RCTs that met the inclusion criteria were analyzed. The median fragility index was 5.5 [95% confidence interval (CI) 1–30] and median reverse fragility index was 13 (95% CI 12.07–16.8) at a p value of 0.05. The median reverse fragility index was 16 (95% CI 10–26) at a p value of 0.01. Most of the RCTs included in this analysis were of good quality, having a median Jadad score of 6. Conclusion This analysis found that the surviving sepsis guidelines were based on highly robust RCTs with statistically insignificant results and on some moderately robust RCTs with statistically significant results. RCTs with statistically insignificant results were more robust than RCTs with statistically significant results in regard to these guidelines. Highlights The study assessed the robustness of randomized controlled trials (RCTs) that were used to formulate surviving sepsis guidelines. Most RCTs showed statistically nonsignificant results. RCTs with statistically significant results were moderately fragile whereas RCTs with nonsignificant results were more robust. How to cite this article Choupoo NS, Das SK, Saikia P, Dey S, Ray S. How Robust are the Evidences that Formulate Surviving Sepsis Guidelines? An Analysis of Fragility and Reverse Fragility of Randomized Controlled Trials that were Referred in these Guidelines. Indian J Crit Care Med 2021;25(7):773–779.

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Unbreakable? An analysis of the fragility of randomized trials that support diabetes treatment guidelines

Cited by 32 publications

References 41 publications

The Fragility of Statistical Significance in Cartilage Restoration of the Knee: A Systematic Review of Randomized Controlled Trials

The Fragility of Statistical Significance in Cartilage Restoration of the Knee: A Systematic Review of Randomized Controlled Trials

Application of the Reverse Fragility Index to Statistically Nonsignificant Randomized Clinical Trial Results

How Robust are the Evidences that Formulate Surviving Sepsis Guidelines? An Analysis of Fragility and Reverse Fragility of Randomized Controlled Trials that were Referred in these Guidelines

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