ArticleJournal of clinical epidemiology2021
The fragility index can be used for sample size calculations in clinical trials.
Article in Journal of clinical epidemiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
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Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- The Statistical Fragility of Saline Nasal Irrigation for Rhinosinusitis: A Systematic Review.The Laryngoscope · 2026Pooled it
- The Statistical Fragility of Marrow Stimulation for Cartilage Defects of the Knee: A Systematic Review of Randomized Controlled Trials.Cartilage · 2024Pooled it
- The fragility index and reverse fragility index of FDA investigational device exemption trials in spinal fusion surgery: a systematic review.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2024Pooled it
- Fragility of Evidence for the Efficacy of Anti-Fracture Medications.The Journal of clinical endocrinology and metabolism · 2025Article
- Assessing the statistical fragility of randomized controlled trials in hip and knee arthroplasty: A methodological review.Journal of orthopaedics · 2025Review
- Half-Dose versus Full Dose of Aprotinin in Cardiac Surgery: A Post-hoc Analysis of the Aprotinin European Registry.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2025Article
- Evaluating the Statistical Fragility of Comparative Studies on Autografts for Pediatric ACL Reconstruction.Orthopaedic journal of sports medicine · 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
- Fragility analysis and systematic review of patellar resurfacing versus non-patellar resurfacing in total knee arthroplasty.Journal of experimental orthopaedics · 2024Article
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- Robustness of Randomized Control Trials Supporting Current Neurosurgery Guidelines.Neurosurgery · 2023Article
- The fragility of significant results from randomized controlled trials in esophageal surgeries.Esophagus : official journal of the Japan Esophageal Society · 2023Review
- Assessing the robustness of results from clinical trials and meta-analyses with the fragility index.American journal of obstetrics and gynecology · 2023Review
- Statistical fragility of reporting hemidiaphragmatic paralysis after brachial plexus blocks in randomized controlled trials: a systematic review.Anesthesiology and perioperative science · 2023Review
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- Paediatric surgical trials, their fragility index, and why to avoid using it to evaluate results.Pediatric surgery international · 2022Article
- Fragility indices for only sufficiently likely modifications.Proceedings of the National Academy of Sciences of the United States of America · 2021Article
- On clinical trial fragility due to patients lost to follow up.BMC medical research methodology · 2021Article
- Beyond the Fragility Index.Pharmaceutical statisticsArticle
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Authors and funding
5 authors.
Funding
Abstract
objectiveThe fragility index is a clinically interpretable metric increasingly used to interpret the robustness of clinical trials results that is generally not incorporated in sample size calculation and applied post-hoc. In this manuscript, we propose to base the sample size calculation on the fragility index in a way that supplements the classical prefixed alpha and power cutoffs and we provide a dedicated R software package for the design and analysis tools. STUDY DESIGN AND
settingThis approach follows from a novel hypothesis testing framework that is based on the fragility index and builds on the classical testing approach. As case studies, we re-analyse the design of two important trials in cardiovascular medicine, the FAME and FAMOUS-NSTEMI trials.
resultsThe analyses show that approach returns sample sizes which results in a higher power for the P value based test and most importantly a lower and context dependent Type I error rate for the fragility index based test compared to standard tests.
conclusionOur method allows clinicians to control for the fragility index during clinical trial design.
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