ReviewAmerican journal of obstetrics and gynecology2023
Assessing the robustness of results from clinical trials and meta-analyses with the fragility index.
Review in American journal of obstetrics and gynecology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Water-soluble contrast agents in adhesional small bowel obstruction: meta-analysis and PRECIS-2 assessment of trials.BJS open · 2025Pooled it
- Exploring the fragility of meta-analyses in ophthalmology: a systematic review.Eye (London, England) · 2024Pooled 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
- Review
- Fragility of Evidence for the Efficacy of Anti-Fracture Medications.The Journal of clinical endocrinology and metabolism · 2025Article
- Post-cesarean skin closure with metal staples versus subcuticular suture in obese patients: A systematic review and meta-analysis of randomized controlled trials.Pregnancy (Hoboken, N.J.) · 2025Article
- A scoping review on metrics to quantify reproducibility: a multitude of questions leads to a multitude of metrics.Royal Society open science · 2025Review
- The Role of Double-Zero-Event Studies in Evidence Synthesis: Evaluating Robustness Using the Fragility Index.Journal of evaluation in clinical practice · 2025Article
- A fragility index analysis of clinical trials evaluating low-intensity extracorporeal shockwave therapy for erectile dysfunction.International journal of impotence research · 2024Review
- Fragility in cardiovascular randomized controlled trials with primary continuous outcomes (2018-2022) from multi-perspectives assessment: a cross-sectional survey.Annals of medicine · 2024Article
- Robustness Assessment of Oncology Dose-Finding Trials Using the Modified Fragility Index.Cancers · 2024Article
- Tipping point analysis for the between-arm correlation in an arm-based evidence synthesis.BMC medical research methodology · 2024Article
- The Fragility of Landmark Randomized Controlled Trials in the Plastic Surgery Literature.Plastic and reconstructive surgery. Global open · 2024Article
- Non-Pharmacological Strategies and Interventions for Effective COVID-19 Control: A Narrative Review.Journal of clinical medicine · 2023Review
- Empirical assessment of fragility index based on a large database of clinical studies in the Cochrane Library.Journal of evaluation in clinical practice · 2023Article
- Beyond the Fragility Index.Pharmaceutical statisticsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
The fragility index has been increasingly used to assess the robustness of the results of clinical trials since 2014. It aims at finding the smallest number of event changes that could alter originally statistically significant results. Despite its popularity, some researchers have expressed several concerns about the validity and usefulness of the fragility index. It offers a comprehensive review of the fragility index's rationale, calculation, software, and interpretation, with emphasis on application to studies in obstetrics and gynecology. This article presents the fragility index in the settings of individual clinical trials, standard pairwise meta-analyses, and network meta-analyses. Moreover, this article provides worked examples to demonstrate how the fragility index can be appropriately calculated and interpreted. In addition, the limitations of the traditional fragility index and some solutions proposed in the literature to address these limitations were reviewed. In summary, the fragility index is recommended to be used as a supplemental measure in the reporting of clinical trials and a tool to communicate the robustness of trial results to clinicians. Other considerations that can aid in the fragility index's interpretation include the loss to follow-up and the likelihood of data modifications that achieve the loss of statistical significance.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.