Urologic oncology randomized controlled trials are frequently fragile - A review of the urology literature

Chertin, Leon; Burman, Irina; Haifler, Miki

doi:10.1016/j.urolonc.2021.04.037

Cited by 3 publications

(7 citation statements)

References 19 publications

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“…Twelve reviews reported FI values stratified by primary vs secondary outcome type. Two studies reported no statistically significant difference between primary and secondary outcome FI values [18, 19], while one study did report a significant difference [14]. Nine reviews investigated the relationship between FI values and journal impact factor.…”

Section: Resultsmentioning

confidence: 99%

“…Four reviews reported no association between risk of bias and FI [14, 21, 32, 52]. Four studies investigated the relationship between FI and patients lost to follow‐up, and three studies [3, 18, 29] found no statistical significance, where one did [19].…”

Section: Resultsmentioning

confidence: 99%

“…They also noted no significant difference between FI and the type of statistical test used to conduct analysis. Chertin et al [14] found a statistically significant difference between FI values in studies in phase II vs studies in phase III ( p = 0.007). Variables associated with FI values are summarized in Table 3.…”

Section: Resultsmentioning

confidence: 99%

“…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%

“…Eleven reviews comprising 645 RCTs reported on correlations between FI and sample size, suggesting that higher FI values were found with higher sample sizes [2, 3, 11, 14, 21–23, 25, 26, 32, 34]. Three systematic reviews reported no association between sample size and FI [15, 31, 35].…”

Section: Resultsmentioning

confidence: 99%

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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%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

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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Fragility of overactive bladder medication clinical trials: A systematic review

Li,

Venishetty,

Fernandez

et al. 2024

Neurourology and Urodynamics

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PurposeOveractive bladder (OAB) syndrome significantly impairs quality of life, often necessitating pharmacological interventions with associated risks. The fragility of OAB trial outcomes, as measured by the fragility index (FI: smallest number of event changes to reverse statistical significance) and quotient (FQ: FI divided by total sample size expressed as a percentage), is critical yet unstudied.Materials and MethodsWe conducted a systematic search for randomized controlled trials on OAB medications published between January 2000 and August 2023. Inclusion criteria were trials with two parallel arms reporting binary outcomes related to OAB medications. We extracted trial details, outcomes, and statistical tests employed. We calculated FI and FQ, analyzing associations with trial characteristics through linear regression.ResultsWe included 57 trials with a median sample size of 211 participants and a 12% median lost to follow‐up. Most studies investigated anticholinergics (37/57, 65%). The median FI/FQ was 5/3.5%. Larger trials were less fragile (median FI 8; FQ 1.0%) compared to medium (FI: 4; FQ 2.5%) and small trials (FI: 4; FQ 8.3%). Double‐blinded studies exhibited higher FQs (median 2.9%) than unblinded trials (6.7%). Primary and secondary outcomes had higher FIs (median 5 and 6, respectively) than adverse events (FI: 4). Each increase in 10 participants was associated with a +0.19 increase in FI (p < 0.001).ConclusionsA change in outcome for a median of five participants, or 3.5% of the total sample size, could reverse the direction of statistical significance in OAB trials. Studies with larger sample sizes and efficacy outcomes from blinded trials were less fragile.

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The fragility index: how robust are the outcomes of head and neck cancer randomised, controlled trials?

Suresh,

Go,

Fritz

et al. 2023

J. Laryngol. Otol.

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Background The fragility index represents the minimum number of patients required to convert an outcome from statistically significant to insignificant. This report assesses the fragility index of head and neck cancer randomised, controlled trials. Methods Studies were extracted from PubMed/Medline, Scopus, Embase and Cochrane databases. Results Overall, 123 randomised, controlled trials were included. The sample size and fragility index medians (interquartile ranges) were 103 (56–213) and 2 (0–5), respectively. The fragility index exceeded the number of patients lost to follow up in 42.3 per cent (n = 52) of studies. A higher fragility index correlated with higher sample size (r = 0.514, p < 0.001), number of events (r = 0.449, p < 0.001) and statistical significance via p-value (r = −0.367, p < 0.001). Conclusion Head and neck cancer randomised, controlled trials demonstrated low fragility index values, in which statistically significant results could be nullified by altering the outcomes of just two patients, on average. Future head and neck oncology randomised, controlled trials should report the fragility index in order to provide insight into statistical robustness.

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Urologic oncology randomized controlled trials are frequently fragile - A review of the urology literature

Cited by 3 publications

References 19 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

Fragility of overactive bladder medication clinical trials: A systematic review

The fragility index: how robust are the outcomes of head and neck cancer randomised, controlled trials?

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