The Fragility of Statistically Significant Randomized Controlled Trials in Plastic Surgery

Chin, Brian; Copeland, Andrea; Gallo, Lucas; Wakeham, Scott; Coroneos, Christopher J.; Walsh, Michael; Thoma, Achilleas; Voineskos, Sophocles H.

doi:10.1097/prs.0000000000006102

Cited by 13 publications

(13 citation statements)

References 25 publications

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“…The median FI was 2 (IQR: 0–4). Eleven studies reported higher FI values associated with lower p values for significant outcomes ( p < = 0.05) [2, 14, 15, 21, 23, 26, 32, 34, 35, 50, 51]. One study reported no correlation between FI and p values for significant outcomes [22].…”

Section: Resultsmentioning

confidence: 99%

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

Vivekanantha

Shah²,

Hoit³

et al. 2023

World j. surg.

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Background The fragility index (FI) is defined as the minimum number of patients or subjects needed to switch experimental groups for statistical significance to be lost in a randomized control trial (RCT). This index is used to determine the robustness of a study's findings and recently as a measure of evaluating RCT quality. The objective of this review was to identify and describe published systematic reviews utilizing FI to evaluate surgical RCTs and to determine if there were common factors associated with higher FI values. Methods Three databases (PubMed, MEDLINE [Ovid], Embase) were searched, followed by a subsequent abstract/ title and full-text screening to yield 50 reviews of surgical RCTs. Authors, year of publication, name of journal, study design, number of RCTs, subspecialty, sample size, median FI, patients lost to follow-up, and associations between variables and FI scores were collected. Results Among 1007 of 2214 RCTs in 50 reviews reporting FI (median sample size 100), the pooled median FI was 3 (IQR: 1-7). Most reviews investigated orthopaedic surgery RCTs (n = 32). There was a moderate correlation between FI and p value (r = 0.-413), a mild correlation between FI and sample size (r = 0.188), and a mild correlation between FI and event number (r = 0.129). Conclusion Based on a limited sample of systematic reviews, surgical RCT FI values are still low (2-5). Future RCTs in surgery require improvement to study design in order to increase the robustness of statistically significant findings.

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Section: Resultsmentioning

confidence: 99%

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

Vivekanantha

Shah²,

Hoit³

et al. 2023

World j. surg.

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“…Subsequently, any synthesis of related RCTs, although it may present low heterogeneity, carries an inherited risk of extrapolated findings. To nutrition's defence however, lower median FI compared with that of MD interventions has been reported in perioperative, 81 anesthesiology, 82 plastic surgery, 83 and critical-care medicine 84 RCTs, as well as among paediatric orthopedic 85 and appendicitis 86 trials. Nevertheless, the synthesis of these trials for recommendations formulation consists of a common practice in the fields mentioned above, as in the science of nutrition.…”

Section: Discussionmentioning

confidence: 99%

How fragile are Mediterranean diet interventions? A research-on-research study of randomised controlled trials

Grammatikopoulou

Nigdelis

Theodoridis

et al. 2021

BMJNPH

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IntroductionThe Mediterranean diet (MD) is a traditional regional dietary pattern and a healthy diet recommended for the primary and secondary prevention of various diseases and health conditions. Results from the higher level of primary evidence, namely randomised controlled trials (RCTs), are often used to produce dietary recommendations; however, the robustness of RCTs with MD interventions is unknown.MethodsA systematic search was conducted and all MD RCTs with dichotomous primary outcomes were extracted from PubMed. The fragility (FI) and the reverse fragility index (RFI) were calculated for the trials with significant and non-significant comparisons, respectively.ResultsOut of 27 RCTs of parallel design, the majority failed to present a significant primary outcome, exhibiting an FI equal to 0. The median FI of the significant comparisons was 5, ranging between 1 and 39. More than half of the comparisons had an FI <5, indicating that the addition of 1–4 events to the treatment arm eliminated the statistical significance. For the comparisons with an FI=0, the RFI ranged between 1 and 29 (Median RFI: 7). When the included RCTs were stratified according to masking, the use of a composite primary endpoint, sample size, outcome category, or dietary adherence assessment method, no differences were exhibited in the FI and RFI between groups, except for the RFI among different compliance assessment methods.ConclusionsIn essence, the present study shows that even in the top tiers of evidence hierarchy, research on the MD may lack robustness, setting concerns for the formulation of nutrition recommendations.

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“…This is a consideration that holds true in other fields of medicine, and a systematic survey of plastic surgery RCTs found that 27% had an FI of 0. 40…”

Section: Discussionmentioning

confidence: 99%

“…3 By comparison, an analysis of the 15 highest impact plastic surgery journals found that a median of one event change led to a loss of statistical significance. 40 In ophthalmology, the median FI was 2, with a median sample size of 92.…”

Section: Discussionmentioning

confidence: 99%

The Fragility Index of Total Hip Arthroplasty Randomized Control Trials: A Systematic Review

Maldonado

et al. 2022

J Am Acad Orthop Surg

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Introduction:Although randomized controlled trials (RCTs) are considered the benchmark study design, a change of outcomes for a few patients can lead to a reversal of study conclusions. As such, examination of the fragility index (FI) of RCTs has become an increasingly popular method to provide further information regarding the relative robustness of RCT results. The purpose of this study was to systematically characterize and assess the predictors of the FI RCTs in total hip arthroplasty literature.Methods:PubMed/MEDLINE, Embase, and Cochrane were systematically searched for all total hip arthroplasty RCTs published between January 2015 and December 2020, which had an equal assignment of participants to a two parallel-arm study design, examined a surgical intervention, and reported on at least one statistically significant dichotomous outcome in the abstract. Potential factors associated with the FI were examined using the Spearman correlation and Mann-Whitney U test.Results:Thirty-four RCTs were selected, with a median number of study participants of 111 (interquartile range [IQR] 72–171] and a median total number of events of 15 (IQR 9.5 to 29). The median FI was 2 (IQR 1 to 6), while six studies had a FI of 0. In 18 cases (52.9%), the number of patients needed to change from no event to event was less than that loss to follow-up. Larger sample size was found to predictive of a higher FI (rs = 0.367, P = 0.033), but the year of publication, journal impact factor, the calculated power analysis size, and loss to follow-up were not associated with FI.Conclusion:The FI serves as a useful addition to other more commonly used approaches of quantitative analyses, such as P values, effect sizes, and confidence intervals, and widespread reporting the FI may provide clinicians with further information about RCT results.Level of Evidence:Level I, systematic review of Level I studies.

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The Fragility of Statistically Significant Randomized Controlled Trials in Plastic Surgery

Cited by 13 publications

References 25 publications

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

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

How fragile are Mediterranean diet interventions? A research-on-research study of randomised controlled trials

The Fragility Index of Total Hip Arthroplasty Randomized Control Trials: A Systematic Review

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