ArticleJournal of evaluation in clinical practice2023
Empirical assessment of fragility index based on a large database of clinical studies in the Cochrane Library.
Article in Journal of evaluation in clinical practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Platelet-Rich Plasma Accelerates the Return to Sport in Athletes with Acute Muscle Injuries: A Systematic Review and Statistical Fragility Index-Based Meta-Analysis of Randomized Controlled Trials.Sports medicine - open · 2026Pooled it
- An alternative method for assessing the fragility of survival analysis results: a proof-of-concept study based on the log-rank test.American journal of epidemiology · 2026Article
- Evaluating the properties of the fragility index of meta-analyses.BMC medical research methodology · 2025Article
- Pediatric lower extremity fracture treatments: a statistical review of randomized controlled trials.Journal of orthopaedics · 2025Review
- The Role of Double-Zero-Event Studies in Evidence Synthesis: Evaluating Robustness Using the Fragility Index.Journal of evaluation in clinical practice · 2025Article
- Assessing robustness of results of randomised clinical trials using Fragility Index.European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2024Article
- Are orthopaedic randomized controlled trials as statistically fragile as portrayed? A call for improved interpretation of the statistical fragility index.Journal of experimental orthopaedics · 2024Article
- Beyond the Fragility Index.Pharmaceutical statisticsArticle
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
RATIONALE AIMS AND
objectivesThe fragility index (FI) and fragility quotient (FQ) are increasingly used measures for assessing the robustness of clinical studies with binary outcomes in terms of statistical significance. The FI is the minimum number of event status modifications that can alter a study result's statistical significance (or nonsignificance), and the FQ is calculated as the FI divided by the study's total sample size. The literature has no widely recognized criteria for interpreting the fragility measures' magnitudes. This article aims to provide an empirical assessment for the FI and FQ based on a large database of clinical studies in the Cochrane Library.
methodsWe explored the overall empirical distributions of the FI and FQ based on five common methods (Fisher's exact test, χ
resultsFor about 20% of studies with significant results, the statistical significance was changed after modifying the event status of only one participant. Studies with significant results were considered slightly fragile if the significance hinged on the statuses of about five events. Studies were extremely fragile if FI
conclusionsThe statistical significance of clinical studies could be changed after modifying a few events' statuses. Many studies' findings are fairly fragile. The distributions of the FI and FQ provide insights for appraising the robustness of evidence in clinical decision-making.
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