Predictors of Increased Fragility Index Scores in Surgical Randomized Controlled Trials: An Umbrella Review

Vivekanantha, Prushoth; Shah, Ajay; Hoit, Graeme; Ayeni, Olufemi R.; Whelan, Daniel B.

doi:10.1007/s00268-023-06928-3

Cited by 5 publications

(1 citation statement)

References 72 publications

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“…These results further exemplify the methodological challenges of conducting high-quality RCTs in surgical specialties [31][32] . In contrast to previous studies [33][34] our analysis of FI among positive studies did not reveal any correlation with the P value, Impact Factor or correlation with the number of patients lost to follow-up, which was di cult to explain. However, among the 8 RCTs analyzed in our study, we identi ed several methodological weaknesses that could in uence the interpretation of their results.…”

Section: Discussioncontrasting

confidence: 99%

Assessing the Robustness of Randomized Controlled Trials on Neuromonitoring in Thyroid Surgery: Utilizing the Fragility and Reverse Fragility Index

Bollo-Arocena,

Gallego,

Carballo

et al. 2024

Preprint

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Purpose The Fragility Index (FI) and Reverse Fragility Index (RFI)) are novel metrics that have been developed to evaluate the robustness of RCTs. The aim of this study was to assess the robustness of RCTs, in the use of intraoperative neuromonitoring (IOMN) in the thyroid surgery field, using FI, RFI, and their respective fragility quotients. Methods A Systematic search was conducted based on the PRISMA which utilized MEDLINE, EMBASE, Cochrane Library, and Web of Science databases. Inclusion criteria included RCTs related to the IONM in the thyroid surgery with dichotomous outcome measures and 1:1 allocation. Fragile results were defined as those with an FI or RFI equal to or less than the number of patients lost to follow-up or those with an FI or RFI less than 3. Results There were 8 RCTs that met our criteria with 2473 patients with 4607 nerves at risk. Among them, 2 (25%) were positive RCTs (p < 0.05) and 6 (75%) were negative RCTs (p > 0.05). The median FI was 2 (IQR 0–2). The median RFI was 3.5 (IQR 1.6–6). Based on the relationship between an FI/RFI ratio of less than 3, two (25%) studies were considered fragile. Furthermore, based on the relationship between FI/RFI and the number of patients lost during follow-up, 4 (50%) studies were considered fragile. Conclusions Using the new metrics, FI and RFI, the RCTs that did not demonstrate superiority with the use of IONM in thyroid surgery were more robust than those that did show superiority. However, controversy regarding the utility of IONM is not closed

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Section: Discussioncontrasting

confidence: 99%

Assessing the Robustness of Randomized Controlled Trials on Neuromonitoring in Thyroid Surgery: Utilizing the Fragility and Reverse Fragility Index

Bollo-Arocena,

Gallego,

Carballo

et al. 2024

Preprint

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Fragility analysis and systematic review of patellar resurfacing versus non‐patellar resurfacing in total knee arthroplasty

Polisetty,

Hohmann,

DiDomenico

et al. 2024

J. exp. orthop.

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IntroductionFragility analysis is a method of further characterising the robustness of statistical outcomes. This study evaluates the statistical fragility of randomised controlled trials (RCTs) comparing patellar resurfacing versus non‐patellar surfacing in total knee arthroplasty (TKA).MethodsPubMed, MEDLINE and EMBASE were searched for RCTs comparing outcomes in TKA based on patellar resurfacing. Fragility index (FI) and reverse FI (collectively, “FI”) were calculated for dichotomous outcomes as the number of outcome reversals needed to change statistical significance. Fragility quotient (FQ) was calculated by dividing the FI by the sample size for that outcome. Median FI and FQ were calculated for each individual outcome and for the overall study. Subanalyses were performed to assess FI and FQ based on outcome type, statistical significance and loss to follow‐up.ResultsTwenty‐one RCTs were included in the analysis, capturing 3910 subjects. The overall median FI was 5.0 (interquartile range, [IQR] 4.0−6.0), and the overall median FQ was 0.048 (IQR 0.022−0.065). The outcome of anterior knee pain has a median FI of 6.0 (IQR 4.0−6.0) and a median FQ of 0.057 (IQR 0.025−0.065). Only five (7%) outcomes were significant. The loss to follow‐up was greater than the FI in 12 of 19 studies (63%) with available data.ConclusionRCTs comparing patellar resurfacing in TKAs show significant statistical fragility; a few outcome reversals can alter findings. The majority of outcomes were nonsignificant, indicating that the choice to resurface the patella may not affect most clinical outcomes; however, clinical conclusions are limited by the statistical fragility of the analysed outcomes. Larger RCTs for this comparison are necessary, and we suggest adding FI and FQ to RCT reports with p values to improve the interpretability of results.Level of EvidenceLevel II.

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How statistically fragile are randomized controlled trials comparing quadriceps tendon autografts with hamstring or bone‐patellar tendon‐bone autografts in anterior cruciate ligament reconstruction?

Dworsky‐Fried,

Bernardini,

Vivekanantha

et al. 2024

Knee surg. sports traumatol. arthrosc.

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PurposeTo determine the statistical fragility of randomized controlled trials (RCTs) which compare the use of quadriceps tendon (QT) autografts to either hamstring tendon (HT) or bone‐patellar tendon‐bone (BPTB) autografts in anterior cruciate ligament reconstruction (ACLR).MethodsA search was conducted across PubMed, MEDLINE and EMBASE databases for RCTs comparing QT autografts to HT or BPTB autografts in ACLR from inception to 21 April 2024. Studies that reported ≥1 statistically significant continuous outcome, statistically significant dichotomous outcome and/or nonsignificant dichotomous outcome were included for analysis. The fragility index (FI), continuous fragility index (CFI) and reverse fragility index (RFI) were calculated for significant dichotomous outcomes, significant continuous outcomes and nonsignificant dichotomous outcomes, respectively.ResultsA total of 11 RCTs comprising 716 patients were included. The mean sample size was 65.8 patients. The median FI among nine outcomes from four studies was 1.0 (interquartile range [IQR], 0.5; 95% confidence interval [CI], 0.6–1.4; range 0.5–1.5). The number of patients lost to follow‐up at the final follow‐up period was more than the study‐specific FI in three (75%) studies. The median CFI among 30 outcomes from six studies was 4.9 (IQR, 10.1, 95% CI, 3.9–8.2; range 0–18.2). The number of patients lost to follow‐up at the final follow‐up period was more than the study‐specific CFI in four (66.7%) studies. The median RFI among 10 outcomes from five studies was 5.0 (IQR, 3.5; 95% CI, 3.4–6.6; range 1.0–9.0). The number of patients lost to follow‐up at the final follow‐up period was more than the study‐specific RFI in four (80%) studies.ConclusionThis systematic review revealed that regardless of the metric used, RCTs comparing QT autografts to HT or BPTB autograft options in ACLR are statistically fragile. While the indices of statistical fragility evaluated in this study are important metrics of robustness to consider, their application in research and clinical practice needs to be further elucidated.Level of EvidenceLevel I.

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Predictors of Increased Fragility Index Scores in Surgical Randomized Controlled Trials: An Umbrella Review

Cited by 5 publications

References 72 publications

Assessing the Robustness of Randomized Controlled Trials on Neuromonitoring in Thyroid Surgery: Utilizing the Fragility and Reverse Fragility Index

Assessing the Robustness of Randomized Controlled Trials on Neuromonitoring in Thyroid Surgery: Utilizing the Fragility and Reverse Fragility Index

Fragility analysis and systematic review of patellar resurfacing versus non‐patellar resurfacing in total knee arthroplasty

How statistically fragile are randomized controlled trials comparing quadriceps tendon autografts with hamstring or bone‐patellar tendon‐bone autografts in anterior cruciate ligament reconstruction?

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